GNPX Genprex Inc

PART I - FINANCIAL INFORMATION

 

Item 1. Financial Statements (unaudited)

 

Genprex, Inc.

 

Condensed Balance Sheets

 

 

See accompanying notes to the unaudited condensed financial statements.

 

 

Genprex, Inc.

 

Condensed Statements of Operations (unaudited)

 

 

See accompanying notes to the unaudited condensed financial statements.

 

 

Genprex, Inc.

 

Condensed Statements of Changes in Stockholders' Equity (unaudited)

 

 

See accompanying notes to the unaudited condensed financial statements.

 

 

Genprex, Inc.

 

Condensed Statements of Cash Flows (unaudited)

 

 

See accompanying notes to the unaudited condensed financial statements.

 

 

GENPREX, INC.

NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

 

Note 1 - Description of Business and Basis of Presentation

 

Unless the context requires otherwise, references to “Genprex,” the “Company,” “we,” “us” or “our” in this Quarterly Report on Form 10-Q refer to Genprex, Inc. We are a clinical stage gene therapy company pioneering the development of gene-based therapies for large patient populations with unmet medical needs. Our oncology platform utilizes our non-viral ONCOPREX® Nanoparticle Delivery System. Using this system, plasmids containing tumor suppressor genes, which are deleted early in the development of cancer, are encapsulated within lipid nanoparticles and administered intravenously to the patient to re-express the deleted tumor suppressor genes. Our diabetes technology is designed to work in Type 1 diabetes by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. In Type 2 diabetes, our technology is believed to work by replenishing and rejuvenating the beta cells that make insulin.

 

Oncology Platform

 

Our lead oncology drug candidate, REQORSA® Immunogene Therapy (generic name: quaratusugene ozeplasmid), previously referred to as GPX-001, uses the ONCOPREX Nanoparticle Delivery System to express the TUSC2 tumor suppressor gene and is initially being developed in combination with prominent cancer drugs to treat Non-Small Cell Lung Cancer (“NSCLC”) and Small Cell Lung Cancer (“SCLC”). The active agent in REQORSA is a plasmid that expresses the TUSC2 tumor suppressor gene. REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis (programmed cell death) in cancer cells, and modulates the immune response against cancer cells. In preclinical studies, REQORSA has been shown to be complementary with targeted drugs and immunotherapies. We believe REQORSA’s unique attributes position REQORSA to provide treatment for patients with NSCLC, SCLC, and possibly other cancers, and that it can improve on current therapies.

 

Acclaim-1: The Acclaim-1 study is a Phase 1/2 clinical trial that has three portions - a Phase 1 dose escalation portion, a Phase 2 expansion portion, and a Phase 2 randomized portion. Acclaim-1 uses a combination of REQORSA and AstraZeneca's Tagrisso® in patients with late-stage NSCLC that has activating epidermal growth factor receptor (“EGFR”) mutations and progression after treatment with Tagrisso. On May 25, 2023, after completion of the Phase 1 portion of the trial, the Safety Review Committee (“SRC”) for the Acclaim-1 clinical trial approved advancement from the Phase 1 dose escalation portion of the trial to the Phase 2 expansion portion of the trial. Based on a review of safety data which showed no dose limiting toxicities (“DLTs”), the SRC determined that the recommended Phase 2 dose of REQORSA will be 0.12 mg/kg. This was the highest dose level delivered in the Phase 1 portion and is twice the highest dose level delivered in the Company’s prior clinical trial combining REQORSA with Tarceva® for the treatment of late-stage lung cancer. We expect we will dose the first patient in the fourth quarter of 2023. The Phase 2 expansion portion of the trial is expected to enroll approximately 66 patients; half will be patients who received only prior Tagrisso treatment and the other half will be patients who received prior Tagrisso treatment and chemotherapy, in order to determine toxicity profiles of patients with different eligibility criteria, as well as efficacy and other endpoints. There will be an interim analysis following the treatment of 19 patients in each cohort. In preparation for the Phase 2 expansion portion of the trial, we are in the process of adding additional clinical sites and in May 2023 amended the protocol to clarify the control arm treatments in the Phase 2 randomized portion of the trial. The Food and Drug Administration (“FDA”) has granted Fast Track Designation for the Acclaim-1 treatment combination of REQORSA and Tagrisso in NSCLC patients who have progressed after Tagrisso treatment.

 

Acclaim-2: The Acclaim-2 study is a Phase 1/2 clinical trial that has three portions - a Phase 1 dose escalation portion, a Phase 2 expansion portion, and a Phase 2 randomized portion. We currently are enrolling and treating patients in the Phase 1 dose escalation portion of Acclaim-2. The Acclaim-2 trial uses a combination of REQORSA and Merck & Co.’s Keytruda® in patients with late-stage NSCLC whose disease has progressed after treatment with Keytruda. Patients are currently being treated at the 0.06 mg/kg dose level in the first cohort of patients and, subject to the Acclaim-2 Safety Review Committee approval, will be treated at successive dose levels of 0.09 mg/kg and 0.12 mg/kg. In March 2023, we amended the Acclaim-2 protocol to include additional treatments in the control group with the goal of accelerating enrollment in the randomized portion of the study. We expect enrollment in the dose escalation portion of the study to be completed in the second quarter of 2024. We will then evaluate patients in the Phase 2 expansion portion of the study at the maximum tolerated dose ("MTD") or recommended Phase 2 dose ("RP2D"). The FDA has granted Fast Track Designation for the Acclaim-2 treatment combination of REQORSA and Keytruda in NSCLC patients who have progressed after Keytruda treatment.

 

Acclaim-3: The Acclaim-3 study has two portions - a Phase 1 dose escalation portion and a Phase 2 expansion portion. In November 2022, we filed with the FDA our protocol for our Phase 1/2 Acclaim-3 clinical trial using a combination of REQORSA and Genentech, Inc.’s Tecentriq® as maintenance therapy in patients with extensive stage small cell lung cancer (“ES-SCLC”) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. We expect to dose the first patient in Acclaim-3 in the fourth quarter of 2023.  Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. In June 2023, the FDA granted Fast Track Designation for the Acclaim-3 treatment combination of REQORSA and Tecentriq as maintenance therapy in patients with ES-SCLC who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. In August 2023, the FDA granted Orphan Drug Designation to REQORSA for the treatment of SCLC. 

 

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We have experienced a delay in the production of a new batch of REQORSA in connection with our transition to a lipid nanoparticle (“LNP”) third party contract development and manufacturing organization (“LNP CDMO”) with advanced and automated processes that we believe will allow us to more efficiently scale our product as we increase production for our trials. We currently estimate that we have enough REQORSA to treat patients receiving REQORSA in our ongoing clinical trials through approximately October 2023. In the event we have not produced another batch of REQORSA by October 2023, treatment of patients in our ongoing clinical trials would be delayed until a new batch of REQORSA is successfully produced. Additionally, the dosing of a first patient in our Phase 2 expansion portion of our Acclaim-1 clinical trial and in our Phase 1 dose escalation portion of our Acclaim-3 clinical trial is pending the availability of a new batch of REQORSA. We expect to produce a new batch of REQORSA in the fourth quarter of 2023; however, if we are incorrect in this estimation, we expect we will experience further delays.

 

In April 2023, at the 2023 Annual Meeting of the American Association of Cancer Researchers (AACR 2023), we presented data that we believe further validates our ONCOPREX Nanoparticle Delivery System platform. These positive pre-clinical data were reported from our University of Texas MD Anderson Cancer Center ("MD Anderson") collaborators and documented the successful delivery of a second tumor suppressor gene, the NPRL2 tumor suppressor gene. The studies used the ONCOPREX Nanoparticle Delivery System to express the NPRL2 gene in anti-PD1 resistant, metastatic human NSCLCs in humanized mouse models. We believe these studies of NPRL2 provide solid data that the ONCOPREX Nanoparticle Delivery System is a platform that can be used with multiple tumor suppressor genes.

 

The TUSC2 gene is one of a series of tumor suppressor genes on the short arm of Chromosome 3. The therapeutic use of TUSC2 is covered by our exclusive worldwide licenses from MD Anderson. NPRL2 is another tumor suppressor gene also located on the short arm of Chromosome 3 and we have filed for patent protection for its therapeutic use. We believe that our ONCOPREX Nanoparticle Delivery System may allow for delivery of a number of other cancer-fighting genes, alone or in combination with other cancer therapies, to combat multiple types of cancer. In August 2022, we entered into a three-year sponsored research agreement with MD Anderson to support further pre-clinical studies of TUSC2 and NPRL2. 

 

Diabetes Gene Therapy

 

In diabetes, we have exclusively licensed from the University of Pittsburgh of the Commonwealth System of Higher Education (“University of Pittsburgh”) multiple technologies relating to the development of a gene therapy product for each of Type 1 and Type 2 diabetes. The same general novel approach is used in each of Type 1 and Type 2 whereby an adeno-associated virus (“AAV”) vector containing the Pdx1 and MafA genes is administered directly into the pancreatic duct. In humans, this can be done with a routine endoscopy procedure. Our diabetes product candidates are currently being evaluated and optimized in preclinical animal studies at the University of Pittsburgh. GPX-002 is being developed for the treatment of Type 1 diabetes and GPX-003 is being developed for the treatment of Type 2 diabetes. GPX-002 is designed to work by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. GPX-003 is believed to work by replenishing and rejuvenating the beta cells that make insulin. We expect to finalize our constructs and request to meet with the FDA before the end of 2023 to obtain their guidance on the toxicology studies that we plan to conduct. In August 2022, we entered into a one-year sponsored research agreement with the University of Pittsburgh for the use of GPX-003 in a non-human primate (“NHP”) model of Type 2 diabetes. We are in the process of extending this agreement and revising the research plan to encompass our most recent technologies to which we acquired exclusive rights from the University of Pittsburgh in July 2023. See also "Note 9 – Subsequent Events" to our interim condensed financial statements included in this Quarterly Report on Form 10-Q.  In February 2023, our research collaborators at the University of Pittsburgh presented preclinical data in a NHP model of Type 1 diabetes highlighting the therapeutic potential of GPX-002 at the 16th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2023) in Berlin, Germany. The study results showed the treated animals had statistically significant decreased insulin requirements, increased c-peptide levels, and improved glucose tolerance compared to baseline. 

 

Capital Requirements, Liquidity and Going Concern Considerations

 

Our unaudited condensed financial statements are prepared in accordance with generally accepted accounting principles in the United States ("U.S. GAAP") applicable to a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. However, as shown in the accompanying unaudited condensed financial statements, we have sustained substantial losses from operations since inception and have no current source of revenue. In addition, we have used, rather than provided, cash in our operations. We expect to continue to incur significant expenditures to further clinical trials for the commercial development of our product candidates.

 

Management recognizes that we must obtain additional capital resources to successfully commercialize our product candidates. To date, we have received funding in the form of equity and debt, and we plan to seek additional funding in the future. However, no assurances can be given that we will be successful in raising additional capital. If we are not able to timely and successfully raise additional capital, the timing of our clinical trials, financial condition and results of operations may be materially and adversely affected. These unaudited condensed financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts and classification of liabilities.

 

The Company believes that our current cash and cash equivalents, including from the net proceeds from the July 2023 Registered Direct Offering, described in Note 9 – Subsequent Events, will be sufficient to fund expenditure requirements for our necessary operations and expected clinical trial activities into the third quarter of 2024. The Company has based these estimates, however, on assumptions that may prove to be wrong, and could spend available financial resources much faster than we currently expect. The Company will need to raise additional funds to continue funding our development and operations. Management plans to secure such additional funding.

 

As a result of the Company’s recurring losses from operations and the need for additional financing to fund its operating and capital requirements, there is uncertainty regarding the Company’s ability to maintain liquidity sufficient to operate its business effectively, which raises substantial doubt as to the Company’s ability to continue as a going concern.

 

See “Note 9 – Subsequent Events – July 2023 Registered Direct Offering” for a description of the Company’s registered direct offering of shares and warrants in July 2023 resulting in net proceeds of approximately $6.7 million.

 

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Note 2 - Summary of Significant Accounting Policies

 

Our unaudited condensed financial statements have been prepared in accordance with U.S. GAAP, and the requirements of the United States ("U.S.") Securities and Exchange Commission (the “SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. Accordingly, they do not include all of the information and footnotes normally included in financial statements prepared in conformity with U.S. GAAP. The December 31, 2022 condensed balance sheet was derived from the December 31, 2022 audited financial statements. They should be read in conjunction with the financial statements and notes thereto included in our 2022 Annual Report on Form 10-K, filed with the SEC on March 31, 2023 (the “Form 10-K”).

 

The accompanying condensed financial statements are unaudited and include all adjustments (consisting of normal recurring adjustments) that management considers necessary for a fair presentation of our condensed financial position and results of operations for the interim periods presented. The results of operations for the interim periods are not necessarily indicative of the results that may be expected for the entire year.

 

A summary of our significant accounting policies consistently applied in the preparation of the accompanying unaudited condensed financial statements follows.

 

Use of Estimates

 

The preparation of our unaudited condensed financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited condensed financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

 

Cash and Cash Equivalents

 

We consider all highly liquid short-term investments with an initial maturity of three months or less to be cash equivalents. Any amounts of cash in financial institutions which exceed FDIC insured limits expose us to cash concentration risk. We have cash in a money market account and had $9,718,036 and $20,679,538 in excess of FDIC insured limits of $250,000 at June 30, 2023 and December 31, 2022, respectively. We have no cash equivalents at June 30, 2023 and December 31, 2022, respectively.

 

Net Loss Per Share

 

Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive shares of common stock, which includes common stock equivalents consisting of (i) 17,453,229 unexercised options granted by our board of directors and warrants to purchase shares of common stock, and (ii) 2,284,580 unvested restricted stock units to purchase shares of common stock granted by our board of directors. 

 

Fair Value of Financial Instruments

 

The carrying amounts reported in the balance sheet for cash, money-market savings account, accounts receivable, and accounts payables approximate fair value because of the immediate or short-term maturity of these financial instruments.

 

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Property and Equipment

 

Furniture and equipment are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets, which range from three to five years. Routine maintenance and repairs are charged to expense as incurred and major renovations or improvements are capitalized.

 

Research and Development Costs

 

Research and development expenditures consist of costs incurred to conduct research, develop engineering materials for further study, and develop clinical strategies for current and future programs. These costs include payments to collaborative research partners, manufacturing partners and consultants, and clinical strategy partners, wages and associated employee benefits, facilities, and overhead costs. These expenditures relate to our preclinical and Phase 1/2 clinical trials and are expensed as incurred. Materials produced to be used in clinical research are capitalized and included in research and development supplies and are expensed as they are used for testing or clinical activities, or have spoiled.

 

Research and development supplies purchased and capitalized for future use were $2,770,955 and $2,864,937 at June 30, 2023 and December 31, 2022, respectively.

 

Intellectual Property

 

Intellectual property consists of legal and related costs associated with patents and other proprietary technology and rights developed, acquired, licensed by, or maintained by us that we believe contribute to a probable economic benefit toward such patents and activities. These costs incurred in connection with obtaining and maintaining intellectual property protection, such as patent applications and patent maintenance, are capitalized. Intellectual property is stated at cost, to be amortized on a straight-line basis over the estimated useful lives of the assets.

 

Accounting for Stock-Based Compensation

 

We use the fair value-based method of accounting for stock-based compensation for options granted to employees, independent consultants and contractors. We measure options granted at fair value determined as of the grant date and recognize the expense over the periods in which the options vest or are expected to vest and related services are rendered based on the terms and conditions of the award. Generally, where the award only has a service condition, the requisite service period is the same as the vesting period.

 

Long-Lived Assets

 

We review long-lived assets and certain identifiable intangibles held and used for possible impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. In evaluating the fair value and future benefits of our intangible assets, management performs an analysis of the anticipated undiscounted future net cash flow of the individual assets over the remaining amortization period. We recognize an impairment loss if the carrying value of the asset exceeds the discounted expected future cash flows. During the six months ended June 30, 2023, and the year ended December 31, 2022, there were no deemed impairments of our long-lived assets.

 

Recent Accounting Developments

 

Accounting pronouncements issued but not effective until after June 30, 2023, are not expected to have a significant effect on our financial condition, results of operations, or cash flows.

 

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Note 3 - Intellectual Property

 

We own or have exclusive license agreements on 20 granted patents and 22 pending patent applications worldwide for technologies developed in-house or by researchers at the National Cancer Institute, MD Anderson, the University of Texas Southwestern Medical Center, and the University of Pittsburgh. These patents comprise various therapeutic, diagnostic, technical and processing claims. These license rights will be amortized on a straight-line basis over the estimated period of useful lives of the underlying patents or the license agreements.

 

University of Pittsburgh

 

On February 11, 2020, we entered into an exclusive license agreement with the University of Pittsburgh for patented gene therapy technologies relating to the potential treatment of Type 1 and Type 2 diabetes. This license was first amended on August 17, 2022, to extend the milestone related to the filing of a new investigational drug ("IND") application. This license was amended again on November 3, 2022, to include a new licensed glucagon promoter technology related to Type 1 diabetes and set FDA and clinical milestones related to the glucagon technology (See Note 7 – Commitments and Contingences – Commitments – University of Pittsburgh).

 

On November 22, 2022, we entered into an exclusive license agreement with the University of Pittsburgh relating to the transformation of macrophages enabling them to reduce autoimmunity activity in Type 1 diabetes. 

 

On December 29, 2022, we entered into an exclusive license agreement with the University of Pittsburgh relating to the use of an insulin promoter in combination with our existing gene therapy, including the Pdx1 and MafA transcription factors, as a potential treatment for Type 2 diabetes.

 

See also "Note 9 – Subsequent Events" to our interim condensed financial statements included in this Quarterly Report on Form 10-Q regarding an additional exclusive license agreement that we entered into with the University of Pittsburgh in July 2023.

 

The University of Texas MD Anderson Cancer Center

 

On May 4, 2020, we entered into an exclusive worldwide license agreement with The Board of Regents of the University of Texas System on behalf of MD Anderson relating to a portfolio of patent applications and related technology for the treatment of cancer using our lead drug candidate and immunotherapies. 

 

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Note 4 - Equity

 

Registered Direct Offering

 

On March 1, 2023, we completed a registered direct offering, in which we sold to an accredited healthcare-focused institutional investor an aggregate of 3,809,524 shares of our common stock and warrants to purchase up to 3,809,524 shares of our common stock, at a combined offering price of $1.05 per share of common stock and accompanying warrant. The warrants are exercisable immediately upon issuance, expire 5 years from the date of issuance and have an exercise price of $1.10 per share. We received net proceeds of approximately $3.6 million after $400,000 of commissions and expenses, excluding any proceeds that may be received in the future from any exercise of the warrants.

 

See “Note 9 – Subsequent Events – July 2023 Registered Direct Offering” for a description of the Company’s registered direct offering of shares and warrants in July 2023 resulting in net proceeds of approximately $6.7 million.

 

At-The-Market Offering

 

On November 18, 2022, we entered into an Equity Distribution Agreement (the "Sales Agreement") with JMP Securities LLC ("JMP Securities") pursuant to which we  may sell from time to time, at our option, shares of our common stock through JMP Securities, as sales agent (the "ATM Facility"), up to an aggregate offering price of $50 million. Sales of the shares pursuant to the ATM Facility were previously made under our prior "shelf" Registration Statement on Form S-3 (Reg. No. 333-239134), and future ATM Facility sales may be made under our currently effective "shelf" Registration Statement on Form S-3 (Reg. No. 333-271386) and a related prospectus supplement for the ATM Facility to be filed as appropriate. Additionally, under the terms of the Sales Agreement, the shares may be sold at market prices, at negotiated prices or at prices related to the prevailing market price. We will pay JMP Securities a commission of 3.0% of the gross proceeds from the sale of the shares. During the year ended December 31, 2022, we sold 3,886 shares of common stock for aggregate net proceeds of $4,532 under the ATM Facility. We did not use the ATM Facility during the three months ended June 30, 2023, and during the six months ended June 30, 2023, we sold 53,592 shares of common stock for aggregate net proceeds of $78,355 under the ATM Facility. 

 

Stock Issuances

 

During the three months ended June 30, 2023, we issued 5,000 shares of common stock for services provided to us valued at $4,400 to the Chairman of our Scientific Advisory Board. During the six months ended June 30, 2023, we issued 10,000 shares of common stock for services provided to us valued at $12,350 to the Chairman of our Scientific Advisory Board (inclusive of the 5,000 shares issued during the three months ended June 30, 2023, as described in the immediately preceding sentence).

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During the three months ended  June 30, 2022, we issued 5,000 shares of common stock for services provided to us valued at $11,150 to the Chairman of our Scientific Advisory Board. During the six months ended June 30, 2022, we issued (i) 10,000 shares of common stock for services provided to us valued at $28,650 to the Chairman of our Scientific Advisory Board (inclusive of the 5,000 shares issued during the three months ended June 30, 2022, as described in the immediately preceding sentence), and (ii) 13,643 shares of common stock upon the exercise of warrants on a cashless basis.

 

Preferred Stock

 

We are authorized to issue 10,000,000 shares of preferred stock with a par value of $0.001 per share, none of which are outstanding at June 30, 2023.

 

Common Stock

 

We are authorized to issue 200,000,000 shares of common stock with a par value of $0.001 per share, all of which are voting common stock. There were 51,979,078 shares of our common stock outstanding at June 30, 2023.

 

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Common Stock Purchase Warrants

 

Common stock purchase warrant activity for the three and six months ended June 30, 2023, and  June 30, 2022, respectively, is as follows:

 

		2023				2022
		Number of		Weighted Average		Number of		Weighted Average
		Warrants		Exercise Price		Warrants		Exercise Price
Outstanding at January 1,		2,147,778		$ 4.32		2,204,747		$ 4.39
Warrants issued		3,839,524		1.10		—		—
Warrants exercised		38,400		6.25		—		—
Outstanding at March 31,		5,948,902		$ 2.23		2,204,747		$ 4.39
Warrants exercised		—		—		13,643		0.50
Warrants cancelled or expired		—		—		112,993		4.47
Outstanding at June 30,		5,948,902		$ 2.23		2,078,111		$ 4.41
Vested at June 30,		22,500		1.50		—		—
Exercisable at June 30,		5,728,069		$ 2.23		1,844,776		$ 4.66

 

We did not issue any warrants during the three-month period ended June 30, 2023. During the six-month period ended June 30, 2023, we issued (i) a warrant to purchase up to 30,000 shares of common stock to a service provider at an exercise price of $1.65 per share, the fair market value of a share of common stock on the date of issuance, and (ii) a warrant to purchase up to 3,809,524 shares of common stock to the accredited healthcare-focused institutional investor in connection with the registered direct offering completed on March 1, 2023, at an exercise price of $1.10 per share. During the three- and six-month periods ended June 30, 2023, we recorded share-based compensation of $34,010 and $77,311, respectively, associated with the vesting and issuance of warrants. We expect to record $13,408 of share-based compensation for time-based vesting through the end of the fiscal year 2023 and $300,000 of share-based compensation based on performance-based vesting in the future with respect to our warrants outstanding as of June 30, 2023.

 

We did not issue any warrants during the three- or six-month periods ended  June 30, 2022. During the six-month period ended June 30, 2022, we issued 13,643 shares of common stock to a placement agent associated with a registered direct offering in November 2019 upon the exercise of warrants on a cashless basis and canceled warrants to purchase 112,993 shares of common stock upon termination of a warrant and warrant shares forfeited associated with a cashless exercise. We recorded no share-based compensation associated warrants during the six-month period ended June 30, 2022.

 

As of June 30, 2023, we had outstanding warrants to purchase 5,948,902 shares of common stock at a weighted average exercise price of $2.23 that have been issued to various consultants, investors, and placement agents. These warrants vest immediately or over periods ranging up to 12 months, are exercisable for a period of up to five years, enable the holders to purchase shares of our common stock at exercise prices ranging from $1.10 to $7.22 per share and have per-share fair values ranging from $0.60 to $4.63, based on Black-Scholes-Merton pricing models. The following assumptions were used in calculation of fair market value of options via Black-Scholes-Merton pricing models for the three and six months ended June 30, 2023:

 

				Three Months Ended June 30, 2023		Six Months Ended June 30, 2023
Expected term (in years):				0		2.5 - 3.0
Risk-free rate:				0%		4.99% - 5.06%
Volatility:				0.00%		83.14%
Dividend yield:				0%		0%

 

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2018 Equity Incentive Plan

 

Our board of directors and stockholders have approved and adopted our 2018 Equity Incentive Plan (“2018 Plan”), which became effective on the completion of our IPO on April 3, 2018. The 2018 Plan provides for the grant of incentive stock options that are intended to qualify under Section 422 of the Internal Revenue Code of 1986, as amended (“ISOs”), nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit ("RSU") awards, performance-based stock awards and performance-based cash awards. ISOs may be granted only to employees. All other awards may be granted to employees, including officers, and to our non-employee directors and consultants.

 

A total of 4,160,000 shares of common stock were initially available under the 2018 Plan, plus a number of shares of common stock (not to exceed 2,628,749 shares) subject to outstanding awards under our 2009 Equity Incentive Plan (the “2009 Plan”) as of the IPO that expire, are forfeited or otherwise terminate or that are used to cover the exercise price or applicable tax withholdings. No further grants will be made under the 2009 Plan.

 

In addition, the number of shares of common stock reserved for issuance under the 2018 Plan automatically increases on January 1 of each year, since  January 1, 2019, by 5% of the total number of shares of our common stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by our Board or a committee appointed to administer the 2018 Plan.

 

On  January 1, 2022 and 2023, the number of shares of common stock reserved for issuance under the 2018 Plan was increased by an aggregate of 2,393,735 and 2,405,298 shares, respectively. As of June 30, 2023, a total of 424,990 shares of common stock remain available for issuance under the 2018 Plan.

 

2018 Employee Stock Purchase Plan

 

Our board of directors and stockholders approved and adopted our 2018 Employee Stock Purchase Plan (“ESPP”), which became effective on April 3, 2018. The ESPP has not yet been utilized as a benefit available to our employees. The ESPP authorizes the issuance of 208,050 shares of our common stock pursuant to purchase rights that may be granted to our eligible employees. The number of shares of common stock reserved for issuance under the ESPP is automatically increased on January 1 of each calendar year, beginning on January 1, 2019, by 2% of the total number of shares of our common stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the administrator of the ESPP. The administrator of the ESPP determined not to increase the number of shares reserved for issuance under the ESPP on  January 1, 2023.

 

Stock Options

 

As of June 30, 2023, we had outstanding stock options to purchase 11,504,327 shares of common stock that have been granted to various executives, other employees, directors, and independent contractors. These options vest immediately or over periods ranging from 12 to 48 months, are exercisable for a period of up to ten years, enable the holders to purchase shares of our common stock at exercise prices ranging from $0.30 to $9.80 per share and have per-share fair values ranging from $0.24 to $7.93, based on Black-Scholes-Merton pricing models. The following assumptions were used in calculation of fair market value of options via Black-Scholes-Merton pricing models for the three months ended June 30, 2023:

 

				Three Months Ended June 30, 2023		Six Months Ended June 30, 2023
Expected term (in years):				6.0		6.0
Risk-free rate:				4.60% – 4.73%		4.60% – 4.73%
Volatility:				83.42%		83.14% - 83.42%
Dividend yield:				0%		0%

 

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During the three-month period ended  June 30, 2023, we granted stock options to purchase an aggregate of 47,500 shares of our common stock with exercise prices ranging from $0.81 to $0.88 per share to employees. During the six-month period ended  June 30, 2023, we granted stock options to purchase an aggregate of 130,000 shares of our common stock with exercise prices ranging from $0.81 to $1.51 per share to employees.

 

During the three-month period ended  June 30, 2022, we granted stock options to purchase an aggregate of 487,604 shares of our common stock with exercise prices ranging from $1.36 to $2.85 per share to board members, executives, other employees and consultants. During the six-month period ended June 30, 2022, we (i) granted stock options to purchase an aggregate of 2,892,166 shares of our common stock with exercise prices ranging from $1.36 to $3.50 per share to board members, executives, other employees and consultants, and (ii) cancelled options to purchase 17,500 shares of common stock at an exercise price of $2.00 in connection with the termination of certain employees.

 

The weighted average remaining contractual term for the outstanding options at  June 30, 2023 and  December 31, 2022 is 6.62 and 7.08 years, respectively.

 

Stock option activity for the six months ended June 30, 2023, and year ended  December 31, 2022 is as follows:

 

 

		2023				2022
		Number of		Weighted Average		Number of		Weighted Average
		Options		Exercise Price		Options		Exercise Price
Outstanding at January 1,		11,374,327		$ 3.08		8,574,301		$ 3.35
Options granted		82,500		1.43		2,404,562		2.30
Options expired or cancelled		—		—		17,500		2.00
Outstanding at March 31,		11,456,827		$ 3.07		10,961,363		$ 3.13
Options granted		47,500		0.85		487,604		1.59
Outstanding at June 30,		11,504,327		$ 3.06		11,448,967		$ 3.06
Vested at June 30,		582,981		2.02		235,465		3.32
Exercisable at June 30,		8,722,617		$ 3.16		6,166,620		$ 3.20

 

Restricted Stock Units

 

A summary of the RSU activity under the 2018 Plan during the six months ended June 30, 2023 is presented below. These amounts include RSUs granted to executives, other employees, and board members. There was no RSU activity for the year ended December 31, 2022.

 

		2023
		Number of		Weighted Average
		Units		Grant Date Fair Value
Outstanding at January 1,		—		—
Restricted stock units granted		1,913,195		1.65
Outstanding at March 31,		1,913,195		$ 1.65
Restricted stock units granted		371,385		0.74
Outstanding at June 30,		2,284,580		$ 1.50
Vested at June 30,		—		—
Expected to vest at June 30,		2,284,580		$ 1.50

 

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Share-Based Compensation

 

For the three and six months ended June 30, 2023, our total share-based compensation was approximately $1.5 million and $2.9 million, respectively, nearly all of which represents the expected vesting of options issued to executives, other employees, and service providers and RSUs issued to executives, other employees, and board members. As of  June 30, 2023, our total compensation cost related to non-vested time-based stock option awards and warrants granted to executives, other employees, board members, and service providers and not yet recognized was approximately $7.3 million. We expect to record this stock-based compensation expense over the next three years using a graded vesting method. As of June 30, 2023, the weighted average term over which these expenses are expected to be recognized is 1.51 years. 

 

For the three- and six-month periods ended June 30, 2022, our total share-based compensation was approximately $1.2 million and $2.2 million, respectively, nearly all of which represents the expected vesting of options issued to executives, other employees, and service providers.

 

As of June 30, 2023, there are no performance-based stock option awards outstanding and one performance-based warrant outstanding issued to a service provider. Our total compensation cost related to the non-vested performance-based warrant not yet recognized was approximately $300,000. The entirety of this warrant may be recognized and recorded upon the achievement of certain clinical milestones.

 

Note 5 - 401(k) Savings Plan

 

In 2022, we established a defined-contribution savings plan under Section 401(k) of the Internal Revenue Code ("401(k) Plan") and established an employer matching program for participants in the 401(k) Plan. The 401(k) Plan covers all employees who meet defined minimum age and service requirements, and allows participants to defer a portion of their annual compensation on a pre-tax basis. We incurred $27,758 and $90,806 of expense for matching contributions to the 401(k) Plan during the three- and six-month periods ended June 30, 2023, respectively. We incurred $22,048 and $25,752 of expense for matching contributions to the 401(k) Plan during the three- and six-month periods ended  June 30, 2022, respectively.

 

Note 6 - Related Party Transactions

 

Introgen Research Institute

 

Introgen Research Institute (“IRI”) is a Texas-based technology company formed by Rodney Varner, our President, Chief Executive Officer and Chairman of the Board and IRI's sole officer. IRI is owned by trusts of which Mr. Varner's descendants are the sole beneficiaries. In April 2009, prior to Mr. Varner becoming an officer and director of our Company in August 2012, we entered into an Assignment and Collaboration Agreement with IRI, providing us with the exclusive right to commercialize a portfolio of intellectual property. This agreement was amended in 2011 to include additional sublicensing of additional intellectual property made available to IRI from MD Anderson (See Note 7 – Commitments and Contingences – Commitments – MD Anderson Cancer Center).

 

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Note 7 - Commitments and Contingencies

 

Commitments

 

MD Anderson Cancer Center

 

In July 2018, we entered into a two-year sponsored research agreement with MD Anderson to sponsor preclinical studies focused on the combination of REQORSA with an immunotherapy with a projected total cost of approximately $2 million. This agreement was extended beyond the original expiration date, expiring in May 2022 after giving effect to such extension. In August 2022, we entered into a three-year sponsored research agreement with MD Anderson to sponsor preclinical studies focused on REQORSA and NPRL2 in oncology to resensitize NSCLC and SCLC to targeted therapies and immunotherapies with a projected total cost of approximately $2.9 million. We incurred approximately $240,000 and $480,000 of expense from this agreement during the three- and six-month periods ended  June 30, 2023, respectively. We did not incur expenses from this agreement during the three- or six-month periods ended  June 30, 2022. As of June 30, 2023, we have paid approximately $720,000 toward this agreement.

 

In 2011, we agreed to assume certain contractual and other obligations of IRI in consideration for the sublicense rights, expertise, and assistance associated with certain technologies and intellectual property originally licensed to another party under the 1994 License Agreement with MD Anderson (“Original MD Anderson License Agreement”). These technologies and intellectual property were later sublicensed to IRI (the “IRI Sublicense”). We also agreed to pay royalties of 1% on sales of certain licensed products for a period of 21 years following the termination of the later of the Original MD Anderson License Agreement and the IRI Sublicense. We assumed patent prosecution costs and an annual minimum royalty of $20,000 payable to the National Institutes of Health.

 

On March 3, 2021, we entered into an amendment (the “MD License Amendment”) to the Patent and Technology License Agreement dated May 4, 2020, with MD Anderson. The MD License Amendment grants us a worldwide, exclusive, sublicensable license to an additional portfolio of six patents and one patent application and related technology for methods for treating cancer by administration of a TUSC2 therapy in conjunction with EGFR inhibitors or other anti-cancer therapies in patients predicted to be responsive to TUSC2 therapy. Pursuant to the MD License Amendment, we agreed to (i) pay annual maintenance fees ranging from the mid five figures to the low six figures, (ii) total milestone payments of $6,150,000, (iii) a one-time fee in the mid five figures and (iv) certain patent related expenses. We incurred $45,000 of expense from this agreement during each of the three- and six-month periods ended  June 30, 2023. We incurred $40,000 and $90,000 of expense from this agreement during the three- and six-month periods ended  June 30, 2022, respectively. As of June 30, 2023, we have paid approximately $320,000 toward this agreement. 

 

National Institutes of Health

 

We have a royalty obligation to the National Institutes of Health ("NIH") to be paid upon our receipt of FDA approval using NIH technology. The $240,000 contingent obligation which increases annually by $20,000 and is $340,000 as of December 31, 2022, and June 30, 2023, and will be recognized when we obtain regulatory approval (the event that triggers the payment obligation).

 

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University of Pittsburgh

 

Pursuant to an exclusive license agreement dated February 11, 2020 by and between us and the University of Pittsburgh, amended on August 17, 2022, and amended again on  November 3, 2022, we agreed to pay (i) an initial licensing fee of $25,000, (ii) annual maintenance fees of $25,000 for the first three years and $40,000 for each subsequent year following the first anniversary of the agreement, (iii) royalties ranging from 1.5% to 3% of net sales of licensed technologies, (iv) an annual minimal royalty payment of $250,000 per year beginning in the year of the first commercial sale of licensed technology, (v) a share of non-royalty sublicense income of 20%, and (vi) an aggregate of $3,975,000 in milestone payments related to the usage of a glucagon promoter and gene therapy technologies to potentially treat Type 1 diabetes. Unless earlier terminated pursuant to its terms, the agreement expires upon the later of (i) 20 years after the first commercial sale of the licensed technology thereunder and (ii) expiration of the last valid claim under the patent rights. We incurred $25,000 of expense from this agreement during each of the three- and six-month periods ended  June 30, 2023. We incurred $25,000 of expense from this agreement during each of the three- and six-month periods ended  June 30, 2022. As of June 30, 2023, we have incurred and paid approximately $110,000 toward this agreement. 

 

Pursuant to an exclusive license agreement dated November 22, 2022 by and between us and the University of Pittsburgh, we agreed to pay (i) an initial licensing fee of $25,000, (ii) annual maintenance fees of $25,000 for the first three years and $40,000 for each subsequent year following the first anniversary of the agreement, (iii) royalties ranging from 1.5% to 3% of net sales of licensed technologies, (iv) an annual minimal royalty payment of $250,000 per year beginning in the year of the first commercial sale of licensed technology, (v) a share of non-royalty sublicense income of 20%, and (vi) an aggregate of $3,975,000 in milestone payments related to the usage of a macrophage technology and gene therapy technologies to potentially treat Type 1 diabetes. Unless earlier terminated pursuant to its terms, the agreement expires upon the later of (i) 20 years after the first commercial sale of the licensed technology thereunder and (ii) expiration of the last valid claim under the patent rights. We incurred $25,000 of expense from this agreement during each of the three- and six-month periods ended  June 30, 2023. We did not incur expenses from this agreement during the three- or six-month periods ended  June 30, 2022. As of June 30, 2023, we have incurred and paid approximately $25,000 toward this agreement. 

 

Pursuant to an exclusive license agreement dated December 29, 2022 by and between us and the University of Pittsburgh, we agreed to pay (i) an initial licensing fee of $25,000, (ii) annual maintenance fees of $25,000 for the first three years and $40,000 for each subsequent year following the first anniversary of the agreement, (iii) royalties ranging from 1.5% to 3% of net sales of licensed technologies, (iv) an annual minimal royalty payment of $250,000 per year beginning in the year of the first commercial sale of licensed technology, (v) a share of non-royalty sublicense income of 20%, and (vi) an aggregate of $3,975,000 in milestone payments related to the usage of an insulin promoter and gene therapy technologies to potentially treat Type 2 diabetes. Unless earlier terminated pursuant to its terms, the agreement expires upon the later of (i) 20 years after the first commercial sale of the licensed technology thereunder and (ii) expiration of the last valid claim under the patent rights. We incurred $25,000 of expense from this agreement during each of the three- and six-month periods ended  June 30, 2023. We did not incur expenses from this agreement during the three- or six-month periods ended  June 30, 2022. As of June 30, 2023, we have paid approximately $25,000 toward this agreement. 

 

Contract Development and Manufacturing Organization

 

We entered into a three-year development services agreement in July 2022, amended in each of January 2023 and March 2023, with a contract development and manufacturing organization to manufacture good manufacturing practices ("GMP") grade materials for use in our clinical trials with a projected total cost of approximately $4.5 million. We incurred approximately $2.3 million and $1.9 million of expense from this agreement during the three and six months ended  June 30, 2023, respectively. We did not incur expenses from this agreement during the three- or six-month periods ended  June 30, 2022. As of June 30, 2023, we have paid approximately $2.4 million toward this agreement.  

 

Contingencies

 

From time to time, we may become subject to threatened and/or asserted claims arising in the ordinary course of our business. Management is not aware of any matters, either individually or in the aggregate, that are reasonably likely to have a material impact on our financial condition, results of operations or liquidity.

 

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Note 8 - Significant Events

 

Effects of the COVID-19 pandemic are still being felt in the U.S. and around the world. The availability of vaccines holds promise for the future, though new variants of the virus and potential waning immunity from vaccines may result in continued impact from this pandemic in the future, which could adversely impact our operations. Through March 31, 2021, we had not experienced any material impact on its financial results or operations as a result of the COVID-19 pandemic. Beginning in June 2021, we experienced delays in engaging clinical sites as a result of a backlog of clinical trial protocols requiring review created by an accumulation of clinical trial protocols. We also have experienced disruptions in our supply chain regarding our manufacturing and testing operations. We continue to closely monitor the impact of the COVID-19 pandemic on its business and workforce.

 

Note 9 - Subsequent Events

 

Share Issuance

 

On July 3, 2023, we issued 5,000 shares of our common stock to the Chairman of our Scientific Advisory Board in consideration for services.

 

License Agreement

 

On July 14, 2023, we entered into an exclusive license agreement with the University of Pittsburgh related to a gene therapy for both Type 1 and Type 2 diabetes using a MafB promoter to drive expression of the Pdx1 and MafA transcription factors. 

 

July 2023 Registered Direct Offering

 

On July 21, 2023, we completed a registered direct offering priced at the market under Nasdaq rules, in which we sold to accredited healthcare-focused institutional investors an aggregate of (i) 7,425,744 shares of our common stock, and (ii) warrants to purchase up to 7,425,744 shares of our common stock, at a combined offering price of $1.01 per share of common stock and accompanying warrant. The warrants are exercisable immediately upon issuance, expire 5 years from the date of issuance and have an exercise price of $0.885 per share.  Also, we agreed to issue to H.C. Wainwright & Co., LLC or its designees (the “Placement Agent”) warrants to purchase up to an aggregate of 445,545 shares of our common stock.  The warrants issued to the Placement Agent have substantially the same terms as the warrants issued to the investors except that the Placement Agent warrants have an exercise price of $1.2625 per share and expire on July 18, 2028. We received net proceeds of approximately $6.7 million after approximately $800,000 of commissions and expenses, excluding any proceeds that may be received in the future from any exercise of the warrants.

 

Warrant Issuances

 

On July 1, 2023, the Company issued a warrant to purchase up to 50,000 shares of its common stock at an exercise price of $0.95 per share to a consultant for services. On August 3, 2023, the Company issued a warrant to purchase up to 15,000 shares of its common stock at an exercise price of $0.73 per share to a consultant for services. On August 10, 2023, the Company issued a warrant to purchase up to 75,000 shares of its common stock at an exercise price of $0.64 per share to a consultant for services.

 

Option Exercise

 

On August 16, 2023, we issued 20,000 shares of common stock for $5,960 in cash to a former board member upon the exercise of options.

 

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

You should read the following Management's Discussion and Analysis of Financial Condition and Results of Operations ("MD&A") together with our interim condensed financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the section titled “Risk Factors” included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as may be amended, supplemented or superseded from time to time by other reports we file with the SEC. All amounts in this report are in United States ("U.S.") dollars, unless otherwise noted.

 

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA

 

This Quarterly Report on Form 10-Q (this “Quarterly Report”) contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). This Quarterly Report contains forward-looking statements that involve substantial risks and uncertainties. Unless the context requires otherwise, references to "Genprex," the "Company," "we," "us" or "our" in this Quarterly Report refer to Genprex, Inc. Any statements in this Quarterly Report about our expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as “believe,” “will,” “expect,” “anticipate,” “estimate,” “intend,” “plan” and “would.” For example, statements concerning financial condition, possible or assumed future results of operations, growth opportunities, industry ranking, plans and objectives of management, markets for our common stock and future management and organizational structure and statements about our current or future product candidates and their development, our beliefs regarding their preclinical or clinical profile or efficacy, and the regulatory approval process and pathway and the timing thereof, are all forward-looking statements. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, levels of activity, performance or achievements to differ materially from any results, levels of activity, performance or achievements expressed or implied by any forward-looking statement. 

 

Any forward-looking statements are qualified in their entirety by reference to the risk factors discussed throughout this Quarterly Report. Some of the risks, uncertainties and assumptions that could cause actual results to differ materially from estimates or projections contained in the forward-looking statements include but are not limited to:

 

●

Market conditions;

  

●

Our capital position;

  

●

Our ability to compete effectively and with larger and/or better-financed biotechnology and pharmaceutical companies;

  

●

Our uncertainty of developing marketable products;

  

●

Our ability to develop and commercialize our products;

  

●

Our ability to obtain regulatory approvals;

  

●

Our ability and third parties’ ability to maintain and protect intellectual property rights;

  

●

Our ability to raise additional future financing and possible lack of financial and other resources, our ability to continue to support and fund our pre-clinical and clinical development programs and growth of our business, and expectations regarding our ability to continue as a going concern;

  

●

The effects and ultimate impact of public health crises such as the coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole;

  

 

●

The success of our clinical trials through all phases of clinical development, including the ability of our third-party suppliers or manufacturers to supply or manufacture our products on a timely, consistent basis in a manner sufficient and appropriate as is commensurate to meet our clinical trial timing, courses of treatment, and other requisite fulfillment considerations necessary to adequately advance our development programs;

    

●

Our ability to conduct and complete our clinical trials in accordance with projected timelines;

  

●

Any delays in regulatory review and approval of our current and future product candidates;

  

●

Our dependence on third-party suppliers or manufacturers to supply or manufacture our key ingredients and/or raw materials, products and/or product components and successfully carry out a sustainable, reproducible and scalable manufacturing process in accordance with specifications or applicable regulations;

  

●

Our ability to control product development costs;

  

●

Our ability to attract and retain key employees;

 

●

Our ability to enter into new strategic collaborations, licensing or other arrangements;

 

●

Changes in government regulation affecting product candidates that could increase our development costs;

 

●

Our involvement in patent, trademark and other intellectual property litigation that could be expensive and divert management’s attention;

 

●

The possibility that there may be no market acceptance for our products; and

 

●

Changes in third-party reimbursement policies which could adversely affect potential future sales of any of our products that are approved for marketing.

 

The foregoing list sets forth some, but not all, of the factors that could affect our ability to achieve results described in any forward-looking statements, which speak only as of the date of this Quarterly Report or the date of the document incorporated by reference into this Quarterly Report.  Except as required by law, we assume no obligation and expressly disclaim any duty to update any forward-looking statement to reflect events or circumstances after the date of this Quarterly Report or to reflect the occurrence of unanticipated events. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements contained in this Quarterly Report. All forward-looking statements are expressly qualified in their entirety by the cautionary statements contained in this section.

 

 

Overview

 

We are a clinical stage gene therapy company pioneering the development of gene-based therapies for large patient populations with unmet medical needs. Our oncology platform utilizes our non-viral ONCOPREX® Nanoparticle Delivery System. Using this system, plasmids containing tumor suppressor genes, which are deleted early in the development of cancer, are encapsulated within lipid nanoparticles and administered intravenously to the patient to re-express the deleted tumor suppressor genes. Our diabetes technology is designed to work in Type 1 diabetes by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. In Type 2 diabetes, our technology is believed to work by replenishing and rejuvenating the beta cells that make insulin.

 

Oncology Platform

 

Our lead oncology drug candidate, REQORSA® Immunogene Therapy (generic name: quaratusugene ozeplasmid), previously referred to as GPX-001, uses the ONCOPREX Nanoparticle Delivery System to express the TUSC2 tumor suppressor gene and is initially being developed in combination with prominent cancer drugs to treat Non-Small Cell Lung Cancer (“NSCLC”) and Small Cell Lung Cancer (“SCLC”). The active agent in REQORSA is a plasmid that expresses the TUSC2 tumor suppressor gene. REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis (programmed cell death) in cancer cells, and modulates the immune response against cancer cells. In preclinical studies, REQORSA has been shown to be complementary with targeted drugs and immunotherapies. We believe REQORSA’s unique attributes position REQORSA to provide treatment for patients with NSCLC, SCLC, and possibly other cancers, and that it can improve on current therapies.

 

Acclaim-1: The Acclaim-1 study is a Phase 1/2 clinical trial that has three portions - a Phase 1 dose escalation portion, a Phase 2 expansion portion, and a Phase 2 randomized portion. Acclaim-1 uses a combination of REQORSA and AstraZeneca's Tagrisso® in patients with late-stage NSCLC that has activating epidermal growth factor receptor (“EGFR”) mutations and progression after treatment with Tagrisso. On May 25, 2023, after completion of the Phase 1 portion of the trial, the Safety Review Committee (“SRC”) for the Acclaim-1 clinical trial approved advancement from the Phase 1 dose escalation portion of the trial to the Phase 2 expansion portion of the trial. Based on a review of safety data which showed no dose limiting toxicities (“DLTs”), the SRC determined that the recommended Phase 2 dose of REQORSA will be 0.12 mg/kg. This was the highest dose level delivered in the Phase 1 portion and is twice the highest dose level delivered in the Company’s prior clinical trial combining REQORSA with Tarceva® for the treatment of late-stage lung cancer. We expect we will dose the first patient in the fourth quarter of 2023. The Phase 2 expansion portion of the trial is expected to enroll approximately 66 patients; half will be patients who received only prior Tagrisso treatment and the other half will be patients who received prior Tagrisso treatment and chemotherapy, in order to determine toxicity profiles of patients with different eligibility criteria, as well as efficacy and other endpoints. There will be an interim analysis following the treatment of 19 patients in each cohort. In preparation for the Phase 2 expansion portion of the trial, we are in the process of adding additional clinical sites and in May 2023 amended the protocol to clarify the control arm treatments in the Phase 2 randomized portion of the trial. The Food and Drug Administration (“FDA”) has granted Fast Track Designation for the Acclaim-1 treatment combination of REQORSA and Tagrisso in NSCLC patients who have progressed after Tagrisso treatment.

 

Acclaim-2: The Acclaim-2 study is a Phase 1/2 clinical trial that has three portions - a Phase 1 dose escalation portion, a Phase 2 expansion portion, and a Phase 2 randomized portion. We currently are enrolling and treating patients in the Phase 1 dose escalation portion of Acclaim-2. The Acclaim-2 trial uses a combination of REQORSA and Merck & Co.’s Keytruda® in patients with late-stage NSCLC whose disease has progressed after treatment with Keytruda. Patients are currently being treated at the 0.06 mg/kg dose level in the first cohort of patients and, subject to the Acclaim-2 Safety Review Committee approval, will be treated at successive dose levels of 0.09 mg/kg and 0.12 mg/kg. In March 2023, we amended the Acclaim-2 protocol to include additional treatments in the control group with the goal of accelerating enrollment in the randomized portion of the study. We expect enrollment in the dose escalation portion of the study to be completed in the second quarter of 2024. We will then evaluate patients in the Phase 2 expansion portion of the study at the maximum tolerated dose ("MTD") or recommended Phase 2 dose ("RP2D"). The FDA has granted Fast Track Designation for the Acclaim-2 treatment combination of REQORSA and Keytruda in NSCLC patients who have progressed after Keytruda treatment.

 

Acclaim-3: The Acclaim-3 study has two portions - a Phase 1 dose escalation portion and a Phase 2 expansion portion. In November 2022, we filed with the FDA our protocol for our Phase 1/2 Acclaim-3 clinical trial using a combination of REQORSA and Genentech, Inc.’s Tecentriq® as maintenance therapy in patients with extensive stage small cell lung cancer (“ES-SCLC”) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. We expect to dose the first patient in Acclaim-3 in the fourth quarter of 2023.  Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. In June 2023, the FDA granted Fast Track Designation for the Acclaim-3 treatment combination of REQORSA and Tecentriq as maintenance therapy in patients with ES-SCLC who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. In August 2023, the FDA granted Orphan Drug Designation to REQORSA for the treatment of SCLC. 

 

We have experienced a delay in the production of a new batch of REQORSA in connection with our transition to a lipid nanoparticle (“LNP”) third party contract development and manufacturing organization (“LNP CDMO”) with advanced and automated processes that we believe will allow us to more efficiently scale our product as we increase production for our trials. We currently estimate that we have enough REQORSA to treat patients receiving REQORSA in our ongoing clinical trials through approximately October 2023. In the event we have not produced another batch of REQORSA by October 2023, treatment of patients in our ongoing clinical trials would be delayed until a new batch of REQORSA is successfully produced. Additionally, the dosing of a first patient in our Phase 2 expansion portion of our Acclaim-1 clinical trial and in our Phase 1 dose escalation portion of our Acclaim-3 clinical trial is pending the availability of a new batch of REQORSA. We expect to produce a new batch of REQORSA in the fourth quarter of 2023; however, if we are incorrect in this estimation, we expect we will experience further delays.

 

In April 2023, at the 2023 Annual Meeting of the American Association of Cancer Researchers (AACR 2023), we presented data that we believe further validates our ONCOPREX Nanoparticle Delivery System platform. These positive pre-clinical data were reported from our University of Texas MD Anderson Cancer Center ("MD Anderson") collaborators and documented the successful delivery of a second tumor suppressor gene, the NPRL2 tumor suppressor gene. The studies used the ONCOPREX Nanoparticle Delivery System to express the NPRL2 gene in anti-PD1 resistant, metastatic human NSCLCs in humanized mouse models. We believe these studies of NPRL2 provide solid data that the ONCOPREX Nanoparticle Delivery System is a platform that can be used with multiple tumor suppressor genes.

 

The TUSC2 gene is one of a series of tumor suppressor genes on the short arm of Chromosome 3. The therapeutic use of TUSC2 is covered by our exclusive worldwide licenses from MD Anderson. NPRL2 is another tumor suppressor gene also located on the short arm of Chromosome 3 and we have filed for patent protection for its therapeutic use. We believe that our ONCOPREX Nanoparticle Delivery System may allow for delivery of a number of other cancer-fighting genes, alone or in combination with other cancer therapies, to combat multiple types of cancer. In August 2022, we entered into a three-year sponsored research agreement with MD Anderson to support further pre-clinical studies of TUSC2 and NPRL2.

 

 

Diabetes Gene Therapy

 

In diabetes, we have exclusively licensed from the University of Pittsburgh of the Commonwealth System of Higher Education (“University of Pittsburgh”) multiple technologies relating to the development of a gene therapy product for each of Type 1 and Type 2 diabetes. The same general novel approach is used in each of Type 1 and Type 2 whereby an adeno-associated virus (“AAV”) vector containing the Pdx1 and MafA genes is administered directly into the pancreatic duct. In humans, this can be done with a routine endoscopy procedure. Our diabetes product candidates are currently being evaluated and optimized in preclinical animal studies at the University of Pittsburgh. GPX-002 is being developed for the treatment of Type 1 diabetes and GPX-003 is being developed for the treatment of Type 2 diabetes. GPX-002 is designed to work by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. GPX-003 is believed to work by replenishing and rejuvenating the beta cells that make insulin. We expect to finalize our constructs and request to meet with the FDA before the end of 2023 to obtain their guidance on the toxicology studies that we plan to conduct. In August 2022, we entered into a one-year sponsored research agreement with the University of Pittsburgh for the use of GPX-003 in a non-human primate (“NHP”) model of Type 2 diabetes. We are in the process of extending this agreement and revising the research plan to encompass our most recent technologies to which we acquired exclusive rights from the University of Pittsburgh in July 2023. See also "Note 9 – Subsequent Events" to our interim condensed financial statements included in this Quarterly Report on Form 10-Q. In February 2023, our research collaborators at the University of Pittsburgh presented preclinical data in a NHP model of Type 1 diabetes highlighting the therapeutic potential of GPX-002 at the 16th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2023) in Berlin, Germany. The study results showed the treated animals had statistically significant decreased insulin requirements, increased c-peptide levels, and improved glucose tolerance compared to baseline. 

 

Recent Developments 

 

Registered Direct Offering

 

On July 21, 2023, we completed a registered direct offering priced at the market under Nasdaq rules, in which we sold to accredited healthcare-focused institutional investors an aggregate of (i) 7,425,744 shares of our common stock, and (ii) warrants to purchase up to 7,425,744 shares of our common stock, at a combined offering price of $1.01 per share of common stock and accompanying warrant. The warrants are exercisable immediately upon issuance, expire 5 years from the date of issuance and have an exercise price of $0.885 per share.  Also, we agreed to issue to H.C. Wainwright & Co., LLC or its designees (the “Placement Agent”) warrants to purchase up to an aggregate of 445,545 shares of our common stock.  The warrants issued to the Placement Agent have substantially the same terms as the warrants issued to the investors except that the Placement Agent warrants have an exercise price of $1.2625 per share and expire on July 18, 2028. We received net proceeds of approximately $6.7 million after $800,000 of commissions and expenses, excluding any proceeds that may be received in the future from any exercise of the warrants.

 

License Agreement

 

On July 14, 2023, we entered into an exclusive license agreement with the University of Pittsburgh related to a gene therapy for both Type 1 and Type 2 diabetes using a MafB promoter to drive expression of the Pdx1 and MafA transcription factors. 

 

JOBS Act

 

On April 5, 2012, the JOBS Act was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. Although we are currently an emerging growth company, we have irrevocably elected not to avail ourselves of this extended transition period and, as a result, we will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies. We have implemented all new accounting pronouncements that are in effect and may affect our financial statements, and we do not believe that there are any other new accounting pronouncements that have been issued that would have a material impact on our financial position or results of operations.

 

Notwithstanding the foregoing, subject to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain exemptions, including, without limitation, the exemption from the requirements (i) to provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act, and (ii) to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We expect that our eligibility to qualify as an “emerging growth company” will end on December 31, 2023, the last day of our fiscal year following the fifth anniversary of the date of our initial public offering.

 

Recently Issued Accounting Pronouncements

 

A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our interim condensed financial statements appearing in this Quarterly Report on Form 10-Q.

 

Critical Accounting Policies and Significant Judgments and Estimates

 

Our condensed financial statements have been prepared in accordance with generally accepted accounting principles in the U.S. ("U.S. GAAP"). The preparation of these condensed financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed financial statements, and the reported amounts of expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

 

We believe that the following accounting policies are the most critical to aid in fully understanding and evaluating our reported financial results, and they require our most difficult, subjective or complex judgments, resulting from the need to make estimates about the effect of matters that are inherently uncertain.

 

 

Research and Development Costs

 

We record accrued expenses for costs invoiced from research and development activities conducted on our behalf by third-party service providers, which include the conduct of preclinical studies and clinical trials and contract research, manufacturing, and testing activities. We record the costs of research and development activities based upon the amount of services provided, and we include these costs in accrued liabilities in the condensed balance sheets and within research and development expense in the condensed statements of operations. These costs are a significant component of our research and development expenses. Purchased materials to be used in future research are capitalized and included in research and development supplies.

 

We estimate the amount of work completed through discussions with internal personnel and external service providers as to the progress or stage of completion of the services and the agreed-upon fee to be paid for such services. We make significant judgments and estimates in determining the accrued balance in each reporting period. As actual costs become known, we adjust our accrued estimates. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed, the number of patients enrolled and the rate of patient enrollment in any of our clinical trials may vary from our estimates and could result in our reporting amounts that are too high or too low in any particular period. Our accrued expenses are dependent, in part, upon the receipt of timely and accurate reporting from contract research organizations ("CROs") and other third-party service providers. To date, there have been no material differences from our accrued expenses to actual expenses. 

 

Impairment of Long-Lived Assets

 

Management reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount may not be realizable or at a minimum annually during the fourth quarter of the year. If an evaluation is required, the estimated future undiscounted cash flows associated with the asset are compared to the asset’s carrying value to determine if an impairment of such asset is necessary. The effect of any impairment would be to expense the difference between the fair value of such asset and its carrying value based upon discounted cash flows.

 

Components of our Results of Operations and Financial Condition

 

Operating expenses

 

We classify our operating expenses into three categories: research and development, general and administrative, and depreciation.

 

Research and development. Research and development expenses consist primarily of:

 

	•	costs incurred to conduct research, such as the discovery and development of our current and potential product candidates;
	•	costs related to the production and storage of supplies for engineering purposes and storage and usage of clinical supplies, including waste created in the process of producing clinical materials, spoilage, and testing of clinical materials;
	•	costs related to the use of contract manufacturers, manufacturing consultants, testing organizations, cold-storage facilities, and logistics service providers;
	•	fees paid to clinical consultants, clinical trial sites and vendors, including CROs in conjunction with implementing and monitoring our clinical trials and acquiring and evaluating clinical trial data, including all related fees, such as patient screening fees, laboratory work, and statistical compilation and analysis;
	•	costs related to compliance with drug development regulatory requirements; and
	•	costs related to staffing and personnel associated with research and development activities, including wages, taxes, benefits, leases, overheads, supplies, and share-based compensation.

 

We recognize all research and development costs as they are incurred. Clinical trial costs, contract manufacturing and other development costs incurred by third parties are expensed as the contracted work is performed.

 

We expect our research and development expenses to increase in the future as we advance our current and future product candidates into and through clinical trials, as we pursue regulatory approval of our current and potential product candidates in the U.S. and Europe, and as we expand our research programs to include new therapies and new therapy combinations. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming. The actual probability of success for our current and potential product candidates may be affected by a variety of factors including the quality of our current and potential product candidates, early clinical data, investment in our clinical program, competition, manufacturing capability and commercial viability, and limited contracted partners. We may never succeed in achieving regulatory approval for any of our current or future product candidates. As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of our product candidates, if at all.

 

General and administrative. General and administrative expense consists of personnel related costs, which include administrative and executive salaries, as well as the costs of professional services, such as accounting and legal, travel, facilities, information technology and other administrative expenses. We expect our general and administrative expense to increase in future periods due to the anticipated growth of our business and related infrastructure as well as accounting, insurance, investor relations, and other costs associated with being a public company.

 

Depreciation. Depreciation expense consists of depreciation from our fixed assets consisting of our property, equipment, and furniture. We depreciate our assets over their estimated useful life. We estimate furniture and computer and office equipment to have a five-year life.

 

 

Results of Operations

 

Comparison of the Three and Six Months Ended June 30, 2023, and 2022

 

The following summarizes our results of operations for the three and six months ended June 30, 2023, and 2022.

 

Research and Development Expense

 

Research and Development ("R&D") expense for the three months ended June 30, 2023 was $3,976,917, compared to $2,926,927 for the three months ended June 30, 2022, an increase of $1,049,990, or 36%. This increase was primarily due to (i) advancements and expansions in our manufacturing programs, including the manufacturing of clinical materials and testing with CDMOs, (ii) increased usage of our CROs for our Acclaim-1 and Acclaim-2 clinical trials as well as startup costs associated with our planned Acclaim-3 clinical trial and (iii) increased usage of sponsored research to support our preclinical programs.

 

R&D expense for the six months ended June 30, 2023, was $9,287,065, compared to $4,967,153 for the six months ended June 30, 2022. This increase of $4,319,912, or 87%, is primarily due to (i) advancements and expansions in our manufacturing programs, including testing and start-up costs associated with the transition to advanced CDMOs experienced in large scale clinical trial and commercial manufacture of gene therapies for operational efficiencies as we advance REQORSA into later stage clinical trials, (ii) increased usage of third-parties, including CROs, to manage and maintain our Acclaim-1 and Acclaim-2 clinical trials, and initiate our planned Acclaim-3 clinical trial and (iii) an increase in R&D personnel from 13 employees at June 30, 2022 to 18 employees on June 30, 2023 to support our manufacturing and pre-clinical and clinical programs. 

 

General and Administrative Expense

 

General and administrative ("G&A") expense for the three months ended June 30, 2023 was $4,054,990, compared to $2,836,916 for the three months ended June 30, 2022, an increase of $1,218,074, or 43%. This increase was primarily due to increases in G&A headcount, professional services, and share-based compensation. 

 

G&A expense for the six months ended June 30, 2023, was $8,012,070, compared to $6,100,656 for the six months ended June 30, 2022. This increase of $1,911,414, or 31%, is primarily due to increases in G&A personnel from 10 employees at June 30, 2022 to 12 employees on June 30, 2023, increased usage in third-parties, including consultants, professional service providers, and legal fees, and increases in share-based compensation.

 

Interest Income. Interest income was $55,551 and $5,744 for the three months ended June 30, 2023 and 2022, respectively, representing an increase of $49,807. The increase associated with interest income for the three months ended June 30, 2023 was primarily due to cashback incentives associated with credit cards and changes in interest rates associated with the cash balances held in money market instruments.

 

Depreciation Expense. Depreciation expense was $3,837 and $6,544 for the three months ended June 30, 2023 and 2022, respectively, representing a decrease of $2,707, or 41%. The changes in associated depreciation expense for the three months ended June 30, 2023 was primarily due to the timing of purchases of computer equipment for new employees and changes to accounting policies related to depreciation.

 

Net Loss. We had a net loss of $7,980,193 and $5,764,643 for the three months ended June 30, 2023 and 2022, respectively, representing an increase of $2,215,550, or 38%. We had a net loss of $17,182,967 and $11,074,460 for the six months ended June 30, 2023 and 2022, respectively, representing an increase of $6,108,507, or 55%. The increases in net loss between these periods was primarily due to an increase in headcount from 21 to 30 employees since June 30, 2022 as well as the expansion of our clinical and manufacturing programs to support our Acclaim-1 and Acclaim-2 clinical trials and our planned Acclaim-3 clinical trial. 

 

Liquidity and Capital Resources

 

From inception through June 30, 2023, we have never generated revenue from product sales and have incurred net losses in each year. As of June 30, 2023, we had an accumulated deficit of $120,010,786. We have funded our operations primarily through the sale and issuance of capital stock. For the year ended December 31, 2022, we sold an aggregate of 3,886 shares of common stock for total net proceeds of $4,532 pursuant to our ATM Facility as governed by the Equity Distribution Agreement (as further described below) and issued 116,973 shares of common stock upon the exercise of options for gross proceeds of $1,755. During the six months ended June 30, 2023, we sold 53,592 shares of common stock for aggregate net proceeds of $78,355 pursuant to our ATM Facility and completed a registered direct offering in which we sold 3,809,524 shares of our common stock and warrants to purchase 3,809,524 shares of our common stock to an accredited healthcare-focused institutional investor for aggregate net proceeds of approximately $3.7 million. See also "Note 4 - Equity - Registered Direct Offering" to our interim condensed financial statements included in this Quarterly Report on Form 10-Q.

 

On November 18, 2022, we entered into our Equity Distribution Agreement (the "Sales Agreement") with JMP Securities LLC as Agent, with respect to an at-the-market offering program (our “ATM Facility”) under which we may offer and sell, from time to time at our sole discretion, shares of our common stock, having an aggregate offering price of up to $50.0 million through the Agent. We have agreed to pay the Agent a commission equal to three percent (3%) of the gross sales proceeds of any shares sold through the Agent under the Sales Agreement and also have provided the Agent with customary indemnification and contribution rights. See also "Note 4 - Equity - At-The-Market Offering" to our interim condensed financial statements included in this Quarterly Report on Form 10-Q. 

 

 

As of June 30, 2023, we had $9,955,684 in cash and cash equivalents. Subsequent to the quarter ended June 30, 2023, on July 21, 2023, we raised approximately $6.7 million in net proceeds in a registered direct offering pursuant to which we sold 7,425,744 shares of common stock and warrants to purchase up to 7,425,744 shares of common stock. See “Note 9 – Subsequent Events – July 2023 Registered Direct Offering” to the Financial Statements included in this Quarterly Report on Form 10-Q.

 

We do not expect to generate revenue from product sales unless and until we successfully complete development of, obtain regulatory approval for and begin to commercialize one or more of our current or potential product candidates, which we expect will take a number of years and which is subject to significant uncertainty. Accordingly, we anticipate that we will need to raise additional capital to fund our future operations, which include conducting our Acclaim-1, Acclaim-2, and Acclaim-3 clinical trials and completing pre-clinical work and conducting clinical trials for our diabetes program. We have completed the Phase 1 dose escalation portion of the Acclaim-1 trial and on May 25, 2023, the Acclaim-1 SRC approved advancement to the Phase 2 expansion portion of the trial. We expect we will dose the first patient in the Phase 2 expansion portion of the trial in the fourth quarter of 2023, subject to the availability of a new batch of REQORSA. We expect enrollment in the dose escalation portion of the Acclaim-2 trial to be completed in the second quarter of 2024 after which we will move into the expansion of the trial subject to approval by the Acclaim-2 SRC. Dosing of the first patient in the Acclaim-3 clinical trial is expected to occur in the fourth quarter of 2023, subject to availability of a new batch of REQORSA. Until such time as we can generate substantial revenue from product sales, if ever, we expect to finance our operating activities through a combination of equity offerings, drawdowns on our ATM Facility pursuant to our Sales Agreement with JMP Securities as Agent, and debt financings and we may seek to raise additional capital through strategic collaborations. However, we may be unable to raise additional funds or enter into such arrangements when needed on favorable terms, or at all, which would have a negative impact on our financial condition and could force us to delay, limit, reduce or terminate our development programs or commercialization efforts or grant rights to others to develop or market product candidates that we would otherwise prefer to develop and market ourselves. Failure to receive additional funding could cause us to curtail or cease our operations. Furthermore, even if we believe we have sufficient funds for our current or future operating plans, we may seek additional capital due to favorable market conditions or strategic considerations.

 

Based on our current cash and cash equivalents, we estimate that we will be able to fund our expenditure requirements for our necessary operations and expected clinical trial activities into the third quarter of 2024. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently plan due to incorrect assumptions or due to a decision to expand our activities beyond those currently planned. We previously have experienced delays in engaging clinical sites as a result of disruptions at these clinical sites caused by the COVID-19 pandemic. We also have experienced delays in clinical trial enrollment as a result of competition for patients and additional time required in connection with our transition to the new LNP CDMO and manufacture of final drug product. Delays in the conduct of our trials could result in utilizing our capital resources sooner without advancing our clinical trials as anticipated.

 

The following table sets forth the primary sources and uses of cash and cash equivalents during the six months ended June 30, 2023, and 2022:

 

		Six Months Ended June 30,
		2023				2022
Net cash used in operating activities		$	(15,039,538	)		$	(8,552,166	)
Net cash used in investing activities			(39,627	)			(23,689	)
Net cash provided by financing activities			4,080,780				—
Net decrease in cash and cash equivalents		$	(10,998,385	)		$	(8,575,855	)

 

Cash used in operating activities

 

Net cash used in operating activities was $15,039,538 and $8,552,166 for the six months ended June 30, 2023, and 2022, respectively, an increase of $6,487,372, or 76%. This increase was primarily due to our personnel expenses growing as a result of an increase in headcount from 21 to 30 employees as well as increases in contract manufacturing and clinical operation expenses associated with our Acclaim-1 and Acclaim-2 trials and our planned Acclaim-3 clinical trial. 

 

Cash used in investing activities

 

Net cash used in investing activities was $39,627 and $23,689 for the six months ended June 30, 2023, and 2022, respectively, an increase of $15,938. This increase was primarily due to timing associated with prosecution costs of our intellectual property. 

 

Cash provided by financing activities

 

Net cash provided by financing activities was $4,080,780 and $0 during the six months ended June 30, 2023, and 2022, respectively. This increase of $4,080,780 was primarily due to sales of common stock in capital raising activities during the six months ended June 30, 2023.  

 

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

The Company is not required to provide the information required by this Item as it is a “smaller reporting company,” as defined in Rule 12b-2 of the Exchange Act.

 

Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

As required by Rules 13a-15(b) and 15d-15(b) of the Exchange Act, our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2023. The term “disclosure controls and procedures” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized, and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Based on that evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that, because of certain material weaknesses in our internal controls over financial reporting, our disclosure controls and procedures were not effective as of June 30, 2023.  The material weaknesses relate to a lack of segregation of duties between accounting and other functions and the absence of sufficient depth of in-house accounting personnel with the ability to properly account for complex transactions.  

 

Due to our size and nature, segregation of all conflicting duties may not always be possible and may not be economically feasible. However, to the extent possible, the initiation of transactions, the custody of assets and the recording of transactions are performed by separate individuals. Our size and nature also do not allow for our accounting staff to have depth of expertise in all areas that might be desirable, such as expertise in accounting for a variety of complex transactions. Management evaluated the impact of our failure to maintain effective segregation of duties and sufficient depth of personnel on our assessment of our internal control over financial reporting and has concluded that these control deficiencies represent material weaknesses. 

 

In response to the material weaknesses described above, during the quarter ended June 30, 2023, we performed additional analysis and other post-closing procedures to ensure our financial statements were prepared in accordance with U.S. GAAP. Accordingly, we believe that the financial statements included in this report fairly present, in all material respects, our financial condition, results of operations and cash flows for the periods presented.

 

Remediation Plans

 

Management is actively engaged in remediation efforts to address the material weaknesses identified in the management’s evaluation of internal controls and procedures. The remediation efforts, which have been or are in the process of being implemented, are intended to address the identified material weaknesses, and include:

 

•

new accounting software, processes, and workflows to further segregate duties among limited accounting staff;

 

•

specific review procedures, including the added involvement of our General Counsel to review certain accounting transactions following a given period in an effort to enhance accuracy of reporting;

 

•

specific review procedures, including the added involvement of our manufacturing staff to enhance controls associated with the tracking and reporting of inventory values in our supply chain;

 

•

a formal Disclosure Committee that has oversight responsibility for the accuracy and timeliness of disclosures made by us through controls and procedures and the monitoring of their integrity and effectiveness; and

 

•

additional hiring of staff and development of accounting processes and policies to further segregate accounting responsibilities and increase the depth of our expertise in accounting for a variety of complex transactions.

 

During the quarter ended June 30, 2023, we took actions to remediate the material weaknesses relating to our internal controls over financial reporting including: (i) the continued implementation of workflow approval processes in our accounting software to further segregate duties, enhance billing accuracy, and ensure transparency and oversight from department leaders, legal, and finance; and (ii) reviewing a plan to engage additional internal staff, external staff, or an advisory firm to provide support on technical issues related to U.S. GAAP as related to the maintenance of our accounting books and records and the preparation of our financial statements. 

 

As Management continues to evaluate and work to improve its internal control over financial reporting, we may take additional measures to address control deficiencies, or we may modify certain of the remediation measures described above. While remediation efforts are active, management requires additional time to demonstrate the operating effectiveness of our remediation efforts. The material weaknesses cannot be considered remediated until the applicable remedial controls operate for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively. 

 

Changes in Internal Control over Financial Reporting

 

Except as described above, there were no changes in our internal control over financial reporting during the quarter ended June 30, 2023, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

Inherent Limitations of Disclosure Controls and Internal Control over Financial Reporting

 

Because of their inherent limitations, our disclosure controls and procedures and our internal control over financial reporting may not prevent material errors or fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. The effectiveness of our disclosure controls and procedures and our internal control over financial reporting is subject to risks, including that the controls may become inadequate because of changes in conditions or that the degree of compliance with our policies or procedures may deteriorate.

 

 

PART II – OTHER INFORMATION

 

Item 1. Legal Proceedings

 

From time to time, we may become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business. Litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm our business. We are currently not aware of any such legal proceedings or claims that will have, individually or in the aggregate, a material adverse effect on our business, financial condition, or operating results.

 

Item 1A. Risk Factors

 

The Company is not required to provide the information required by this Item as it is a “smaller reporting company,” as defined in Rule 12b-2 of the Exchange Act.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

During the three months ended June 30, 2023, we issued and sold the following unregistered securities:

 

On April 1, 2023, we issued 5,000 shares of our common stock to the Chairman of our Scientific Advisory Board in consideration for services during the three months ended June 30, 2023.

 

The foregoing issuance of securities was not registered under the Securities Act or the securities laws of any state, and the securities were offered and issued in reliance on the exemption from registration under the Securities Act afforded by Section 4(a)(2).

 

Item 3. Defaults Upon Senior Securities

 

None.

 

Item 4. Mine Safety Disclosures

 

Not applicable.

 

Item 5. Other Information

 

None.

 

Item 6. Exhibits

 

 

INDEX TO EXHIBITS

 

Exhibit Number		Description of Exhibit
10.1+		Genprex, Inc. Amended and Restated Outside Director Compensation Policy, adopted June 27, 2023, incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed on June 27, 2023.
31.1*		Certification of Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*		Certification of Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1**		Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS*		Inline XBRL Instance Document.
101.SCH*		Inline XBRL Taxonomy Extension Schema Document.
101.CAL*		Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF*		Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB*		Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE*		Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104*		Cover Page Interactive Data File (Formatted as Inline XBRL and contained in Exhibit 101).

 

*  Filed herewith.

** Furnished herewith.

+  Indicates management contract or compensatory plan.

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

	GENPREX, INC.
Date: August 21, 2023	By:	/s/ J. Rodney Varner
		J. Rodney Varner
		Chief Executive Officer
		(Principal Executive Officer)
	By:	/s/ Ryan M. Confer
		Ryan M. Confer
		Chief Financial Officer
		(Principal Financial and Accounting Officer)

 

Exhibit 31.1

 

CERTIFICATION OF CHIEF EXECUTIVE OFFICER OF GENPREX, INC. PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, J. Rodney Varner, certify that:

 

1.

I have reviewed this quarterly report on Form 10-Q of Genprex, Inc., a Delaware corporation (the “registrant”);

 

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.

The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c)

Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d)

Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

 

5.

The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

 

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

 

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

 

Date: August 21, 2023	By:	/s/ J. Rodney Varner
		J. Rodney Varner
		Chief Executive Officer
		(Principal Executive Officer)

 

Exhibit 31.2

 

CERTIFICATION OF CHIEF FINANCIAL OFFICER OF GENPREX, INC. PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Ryan M. Confer, certify that:

 

1.

I have reviewed this quarterly report on Form 10-Q of Genprex, Inc., a Delaware corporation (the “registrant”);

 

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.

The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c)

Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d)

Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

 

5.

The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

 

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

 

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

 

Date: August 21, 2023	By:	/s/ Ryan M. Confer
		Ryan M. Confer Chief Financial Officer (Principal Financial and Accounting Officer)

 

Exhibit 32.1

 

CERTIFICATIONS OF CEO AND CFO PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report on Form 10-Q of Genprex, Inc. (the “Company”) for the quarter ended June 30, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned, J. Rodney Varner, Chief Executive Officer of the Company, and Ryan M. Confer, Chief Financial Officer of the Company, hereby certifies, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that to the best of his knowledge:

 

(1)

The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2)

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

 

Date: August 21, 2023	By:	/s/ J. Rodney Varner
		J. Rodney Varner
		Chief Executive Officer
		(Principal Executive Officer)
	By:	/s/ Ryan M. Confer
		Ryan M. Confer
		Chief Financial Officer
		(Principal Financial and Accounting Officer)

 

This certification accompanies the Report, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Report), irrespective of any general incorporation language contained in such filing.

 

v3.23.2

Document And Entity Information - shares	6 Months Ended
	Jun. 30, 2023	Aug. 10, 2023
Document Information [Line Items]
Entity Central Index Key	0001595248
Entity Registrant Name	Genprex, Inc.
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Document Fiscal Period Focus	Q2
Document Fiscal Year Focus	2023
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Jun. 30, 2023
Document Transition Report	false
Entity File Number	001-38244
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	90-0772347
Entity Address, Address Line One	3300 Bee Cave Road, #650-227
Entity Address, City or Town	Austin
Entity Address, State or Province	TX
Entity Address, Postal Zip Code	78746
City Area Code	512
Local Phone Number	537-7997
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	GNPX
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	true
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		59,409,822

v3.23.2

Condensed Balance Sheets (Current Period Unaudited) - USD ($)	Jun. 30, 2023	Dec. 31, 2022
Current assets:
Cash and cash equivalents	$ 9,955,684	$ 20,954,069
Accounts receivable	0	34,852
Prepaid expenses and other	2,410,425	484,224
Total current assets	12,366,109	21,473,145
Property and equipment, net	15,179	23,032
Other non-current assets:
Security deposits	17,154	21,818
Supplies	2,770,955	2,864,937
Intellectual property, net	741,722	702,095
Total other assets	3,529,831	3,588,850
Total assets	15,911,119	25,085,027
Current liabilities:
Accounts payables	1,497,979	442,925
Other current liabilities	2,362,267	2,367,362
Total current liabilities	3,860,246	2,810,287
Commitments and contingencies
Stockholders’ equity:
Preferred stock $0.001 par value: 10,000,000 shares authorized; no shares issued and outstanding	0	0
Common stock $0.001 par value: 200,000,000 shares authorized; 51,979,078 and 48,105,962 shares issued and outstanding at June 30, 2023, and December 31, 2022, respectively	51,979	48,106
Additional paid-in capital	132,009,680	125,054,453
Accumulated deficit	(120,010,786)	(102,827,819)
Total stockholders’ equity	12,050,873	22,274,740
Total liabilities and stockholders’ equity	$ 15,911,119	$ 25,085,027

v3.23.2

Condensed Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares	Jun. 30, 2023	Dec. 31, 2022
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized (in shares)	10,000,000	10,000,000
Preferred stock, shares issued (in shares)	0	0
Preferred stock, shares outstanding (in shares)	0	0
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized (in shares)	200,000,000	200,000,000
Common stock, shares issued (in shares)	51,979,078	48,105,962
Common stock, shares outstanding (in shares)	51,979,078	48,105,962

v3.23.2

Condensed Statements of Operations (Unaudited) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Cost and expenses:
Depreciation	$ 3,837	$ 6,544	$ 7,853	$ 13,274
Research and development	3,976,917	2,926,927	9,287,065	4,967,153
General and administrative	4,054,990	2,836,916	8,012,070	6,100,656
Total costs and expenses	8,035,744	5,770,387	17,306,988	11,081,083
Operating loss	(8,035,744)	(5,770,387)	(17,306,988)	(11,081,083)
Interest income	55,551	5,744	124,021	6,623
Net loss	$ (7,980,193)	$ (5,764,643)	$ (17,182,967)	$ (11,074,460)
Net loss per share—basic and diluted (in dollars per share)	$ (0.15)	$ (0.12)	$ (0.34)	$ (0.23)
Weighted average number of common shares— basic and diluted (in shares)	51,978,968	47,893,404	50,732,237	47,886,538

v3.23.2

Condensed Statements of Changes in Stockholders' Equity (Unaudited) - USD ($)	Common Stock [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member]	Total
Balance (in shares) at Dec. 31, 2021	47,874,708
Balance at Dec. 31, 2021	$ 47,874	$ 120,316,315	$ (79,087,198)	$ 41,276,991
Issuance of stock for services (in shares)	5,000
Issuance of stock for services	$ 5	17,495	0	17,500
Share-based compensation	0	1,039,940	0	1,039,940
Net loss	$ 0	0	(5,309,817)	(5,309,817)
Balance (in shares) at Mar. 31, 2022	47,879,708
Balance at Mar. 31, 2022	$ 47,879	121,373,750	(84,397,015)	37,024,614
Balance (in shares) at Dec. 31, 2021	47,874,708
Balance at Dec. 31, 2021	$ 47,874	120,316,315	(79,087,198)	41,276,991
Net loss				(11,074,460)
Balance (in shares) at Jun. 30, 2022	47,898,351
Balance at Jun. 30, 2022	$ 47,898	122,525,045	(90,161,658)	32,411,285
Balance (in shares) at Mar. 31, 2022	47,879,708
Balance at Mar. 31, 2022	$ 47,879	121,373,750	(84,397,015)	37,024,614
Issuance of stock for services (in shares)	18,643
Issuance of stock for services	$ 19	17,953	0	17,972
Share-based compensation	0	1,133,342	0	1,133,342
Net loss	$ 0	0	(5,764,643)	(5,764,643)
Issuance of stock for cash (in shares)	0
Issuance of stock for cash	$ 0	0	0	0
Balance (in shares) at Jun. 30, 2022	47,898,351
Balance at Jun. 30, 2022	$ 47,898	122,525,045	(90,161,658)	32,411,285
Balance (in shares) at Dec. 31, 2022	48,105,962
Balance at Dec. 31, 2022	$ 48,106	125,054,453	(102,827,819)	22,274,740
Issuance of stock for services (in shares)	5,000
Issuance of stock for services	$ 5	7,945	0	7,950
Share-based compensation	0	1,324,165	0	1,324,165
Net loss	$ 0	0	(9,202,774)	(9,202,774)
Issuance of stock for cash (in shares)	3,863,116
Issuance of stock for cash	$ 3,863	4,076,917	0	4,080,780
Balance (in shares) at Mar. 31, 2023	51,974,078
Balance at Mar. 31, 2023	$ 51,974	130,463,480	(112,030,593)	18,484,861
Balance (in shares) at Dec. 31, 2022	48,105,962
Balance at Dec. 31, 2022	$ 48,106	125,054,453	(102,827,819)	22,274,740
Net loss				(17,182,967)
Balance (in shares) at Jun. 30, 2023	51,979,078
Balance at Jun. 30, 2023	$ 51,979	132,009,680	(120,010,786)	12,050,873
Balance (in shares) at Mar. 31, 2023	51,974,078
Balance at Mar. 31, 2023	$ 51,974	130,463,480	(112,030,593)	18,484,861
Issuance of stock for services (in shares)	5,000
Issuance of stock for services	$ 5	4,395	0	4,400
Share-based compensation	0	1,541,805	0	1,541,805
Net loss	$ 0	0	(7,980,193)	(7,980,193)
Balance (in shares) at Jun. 30, 2023	51,979,078
Balance at Jun. 30, 2023	$ 51,979	$ 132,009,680	$ (120,010,786)	$ 12,050,873

v3.23.2

Condensed Statements of Cash Flows (Unaudited) - USD ($)	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Cash flows from operating activities:
Net loss	$ (17,182,967)	$ (11,074,460)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	7,853	13,274
Share-based compensation	2,878,320	2,208,754
Changes in operating assets and liabilities:
Accounts receivable	34,852	0
Prepaid expenses and other	(1,921,536)	(337,762)
Research and development supplies	93,982	69,485
Accounts payable	1,055,054	(289,872)
Other current liabilities	(5,096)	858,415
Net cash used in operating activities	(15,039,538)	(8,552,166)
Cash flows from investing activities:
Additions to intellectual property	(39,627)	(23,689)
Net cash used in investing activities	(39,627)	(23,689)
Cash flows from financing activities:
Proceeds from issuances of stock and warrants	4,080,780	0
Net cash provided by financing activities	4,080,780	0
Net decrease in cash and cash equivalents	(10,998,385)	(8,575,855)
Cash and cash equivalents, beginning of period	20,954,069	38,628,876
Cash and cash equivalents, end of period	$ 9,955,684	$ 30,053,021

v3.23.2

Note 1 - Description of Business and Basis of Presentation	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block]	Note 1 - Description of Business and Basis of Presentation   Unless the context requires otherwise, references to “Genprex,” the “Company,” “we,” “us” or “our” in this Quarterly Report on Form 10-Q refer to Genprex, Inc. We are a clinical stage gene therapy company pioneering the development of gene-based therapies for large patient populations with unmet medical needs. Our oncology platform utilizes our non-viral ONCOPREX® Nanoparticle Delivery System. Using this system, plasmids containing tumor suppressor genes, which are deleted early in the development of cancer, are encapsulated within lipid nanoparticles and administered intravenously to the patient to re-express the deleted tumor suppressor genes. Our diabetes technology is designed to work in Type 1 diabetes by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. In Type 2 diabetes, our technology is believed to work by replenishing and rejuvenating the beta cells that make insulin.   Oncology Platform   Our lead oncology drug candidate, REQORSA® Immunogene Therapy (generic name: quaratusugene ozeplasmid), previously referred to as GPX-001, uses the ONCOPREX Nanoparticle Delivery System to express the TUSC2 tumor suppressor gene and is initially being developed in combination with prominent cancer drugs to treat Non-Small Cell Lung Cancer (“NSCLC”) and Small Cell Lung Cancer (“SCLC”). The active agent in REQORSA is a plasmid that expresses the TUSC2 tumor suppressor gene. REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis (programmed cell death) in cancer cells, and modulates the immune response against cancer cells. In preclinical studies, REQORSA has been shown to be complementary with targeted drugs and immunotherapies. We believe REQORSA’s unique attributes position REQORSA to provide treatment for patients with NSCLC, SCLC, and possibly other cancers, and that it can improve on current therapies.   Acclaim-1: The Acclaim-1 study is a Phase 1/2 clinical trial that has three portions - a Phase 1 dose escalation portion, a Phase 2 expansion portion, and a Phase 2 randomized portion. Acclaim-1 uses a combination of REQORSA and AstraZeneca's Tagrisso® in patients with late-stage NSCLC that has activating epidermal growth factor receptor (“EGFR”) mutations and progression after treatment with Tagrisso. On May 25, 2023, after completion of the Phase 1 portion of the trial, the Safety Review Committee (“SRC”) for the Acclaim-1 clinical trial approved advancement from the Phase 1 dose escalation portion of the trial to the Phase 2 expansion portion of the trial. Based on a review of safety data which showed no dose limiting toxicities (“DLTs”), the SRC determined that the recommended Phase 2 dose of REQORSA will be 0.12 mg/kg. This was the highest dose level delivered in the Phase 1 portion and is twice the highest dose level delivered in the Company’s prior clinical trial combining REQORSA with Tarceva® for the treatment of late-stage lung cancer. We expect we will dose the first patient in the fourth quarter of 2023. The Phase 2 expansion portion of the trial is expected to enroll approximately 66 patients; half will be patients who received only prior Tagrisso treatment and the other half will be patients who received prior Tagrisso treatment and chemotherapy, in order to determine toxicity profiles of patients with different eligibility criteria, as well as efficacy and other endpoints. There will be an interim analysis following the treatment of 19 patients in each cohort. In preparation for the Phase 2 expansion portion of the trial, we are in the process of adding additional clinical sites and in May 2023 amended the protocol to clarify the control arm treatments in the Phase 2 randomized portion of the trial. The Food and Drug Administration (“FDA”) has granted Fast Track Designation for the Acclaim-1 treatment combination of REQORSA and Tagrisso in NSCLC patients who have progressed after Tagrisso treatment.   Acclaim-2: The Acclaim-2 study is a Phase 1/2 clinical trial that has three portions - a Phase 1 dose escalation portion, a Phase 2 expansion portion, and a Phase 2 randomized portion. We currently are enrolling and treating patients in the Phase 1 dose escalation portion of Acclaim-2. The Acclaim-2 trial uses a combination of REQORSA and Merck & Co.’s Keytruda® in patients with late-stage NSCLC whose disease has progressed after treatment with Keytruda. Patients are currently being treated at the 0.06 mg/kg dose level in the first cohort of patients and, subject to the Acclaim-2 Safety Review Committee approval, will be treated at successive dose levels of 0.09 mg/kg and 0.12 mg/kg. In March 2023, we amended the Acclaim-2 protocol to include additional treatments in the control group with the goal of accelerating enrollment in the randomized portion of the study. We expect enrollment in the dose escalation portion of the study to be completed in the second quarter of 2024. We will then evaluate patients in the Phase 2 expansion portion of the study at the maximum tolerated dose ("MTD") or recommended Phase 2 dose ("RP2D"). The FDA has granted Fast Track Designation for the Acclaim-2 treatment combination of REQORSA and Keytruda in NSCLC patients who have progressed after Keytruda treatment.   Acclaim-3: The Acclaim-3 study has two portions - a Phase 1 dose escalation portion and a Phase 2 expansion portion. In November 2022, we filed with the FDA our protocol for our Phase 1/2 Acclaim-3 clinical trial using a combination of REQORSA and Genentech, Inc.’s Tecentriq® as maintenance therapy in patients with extensive stage small cell lung cancer (“ES-SCLC”) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. We expect to dose the first patient in Acclaim-3 in the fourth quarter of 2023.  Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. In June 2023, the FDA granted Fast Track Designation for the Acclaim-3 treatment combination of REQORSA and Tecentriq as maintenance therapy in patients with ES-SCLC who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. In August 2023, the FDA granted Orphan Drug Designation to REQORSA for the treatment of SCLC.    We have experienced a delay in the production of a new batch of REQORSA in connection with our transition to a lipid nanoparticle (“LNP”) third party contract development and manufacturing organization (“LNP CDMO”) with advanced and automated processes that we believe will allow us to more efficiently scale our product as we increase production for our trials. We currently estimate that we have enough REQORSA to treat patients receiving REQORSA in our ongoing clinical trials through approximately October 2023. In the event we have not produced another batch of REQORSA by October 2023, treatment of patients in our ongoing clinical trials would be delayed until a new batch of REQORSA is successfully produced. Additionally, the dosing of a first patient in our Phase 2 expansion portion of our Acclaim-1 clinical trial and in our Phase 1 dose escalation portion of our Acclaim-3 clinical trial is pending the availability of a new batch of REQORSA. We expect to produce a new batch of REQORSA in the fourth quarter of 2023; however, if we are incorrect in this estimation, we expect we will experience further delays.   In April 2023, at the 2023 Annual Meeting of the American Association of Cancer Researchers (AACR 2023), we presented data that we believe further validates our ONCOPREX Nanoparticle Delivery System platform. These positive pre-clinical data were reported from our University of Texas MD Anderson Cancer Center ("MD Anderson") collaborators and documented the successful delivery of a second tumor suppressor gene, the NPRL2 tumor suppressor gene. The studies used the ONCOPREX Nanoparticle Delivery System to express the NPRL2 gene in anti-PD1 resistant, metastatic human NSCLCs in humanized mouse models. We believe these studies of NPRL2 provide solid data that the ONCOPREX Nanoparticle Delivery System is a platform that can be used with multiple tumor suppressor genes.   The TUSC2 gene is one of a series of tumor suppressor genes on the short arm of Chromosome 3. The therapeutic use of TUSC2 is covered by our exclusive worldwide licenses from MD Anderson. NPRL2 is another tumor suppressor gene also located on the short arm of Chromosome 3 and we have filed for patent protection for its therapeutic use. We believe that our ONCOPREX Nanoparticle Delivery System may allow for delivery of a number of other cancer-fighting genes, alone or in combination with other cancer therapies, to combat multiple types of cancer. In August 2022, we entered into a three-year sponsored research agreement with MD Anderson to support further pre-clinical studies of TUSC2 and NPRL2.    Diabetes Gene Therapy   In diabetes, we have exclusively licensed from the University of Pittsburgh of the Commonwealth System of Higher Education (“University of Pittsburgh”) multiple technologies relating to the development of a gene therapy product for each of Type 1 and Type 2 diabetes. The same general novel approach is used in each of Type 1 and Type 2 whereby an adeno-associated virus (“AAV”) vector containing the Pdx1 and MafA genes is administered directly into the pancreatic duct. In humans, this can be done with a routine endoscopy procedure. Our diabetes product candidates are currently being evaluated and optimized in preclinical animal studies at the University of Pittsburgh. GPX-002 is being developed for the treatment of Type 1 diabetes and GPX-003 is being developed for the treatment of Type 2 diabetes. GPX-002 is designed to work by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. GPX-003 is believed to work by replenishing and rejuvenating the beta cells that make insulin. We expect to finalize our constructs and request to meet with the FDA before the end of 2023 to obtain their guidance on the toxicology studies that we plan to conduct. In August 2022, we entered into a one-year sponsored research agreement with the University of Pittsburgh for the use of GPX-003 in a non-human primate (“NHP”) model of Type 2 diabetes. We are in the process of extending this agreement and revising the research plan to encompass our most recent technologies to which we acquired exclusive rights from the University of Pittsburgh in July 2023. See also "Note 9 – Subsequent Events" to our interim condensed financial statements included in this Quarterly Report on Form 10-Q.  In February 2023, our research collaborators at the University of Pittsburgh presented preclinical data in a NHP model of Type 1 diabetes highlighting the therapeutic potential of GPX-002 at the 16th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2023) in Berlin, Germany. The study results showed the treated animals had statistically significant decreased insulin requirements, increased c-peptide levels, and improved glucose tolerance compared to baseline.    Capital Requirements, Liquidity and Going Concern Considerations   Our unaudited condensed financial statements are prepared in accordance with generally accepted accounting principles in the United States ("U.S. GAAP") applicable to a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. However, as shown in the accompanying unaudited condensed financial statements, we have sustained substantial losses from operations since inception and have no current source of revenue. In addition, we have used, rather than provided, cash in our operations. We expect to continue to incur significant expenditures to further clinical trials for the commercial development of our product candidates.   Management recognizes that we must obtain additional capital resources to successfully commercialize our product candidates. To date, we have received funding in the form of equity and debt, and we plan to seek additional funding in the future. However, no assurances can be given that we will be successful in raising additional capital. If we are not able to timely and successfully raise additional capital, the timing of our clinical trials, financial condition and results of operations may be materially and adversely affected. These unaudited condensed financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts and classification of liabilities.   The Company believes that our current cash and cash equivalents, including from the net proceeds from the July 2023 Registered Direct Offering, described in Note 9 – Subsequent Events, will be sufficient to fund expenditure requirements for our necessary operations and expected clinical trial activities into the third quarter of 2024. The Company has based these estimates, however, on assumptions that may prove to be wrong, and could spend available financial resources much faster than we currently expect. The Company will need to raise additional funds to continue funding our development and operations. Management plans to secure such additional funding.   As a result of the Company’s recurring losses from operations and the need for additional financing to fund its operating and capital requirements, there is uncertainty regarding the Company’s ability to maintain liquidity sufficient to operate its business effectively, which raises substantial doubt as to the Company’s ability to continue as a going concern.   See “Note 9 – Subsequent Events – July 2023 Registered Direct Offering” for a description of the Company’s registered direct offering of shares and warrants in July 2023 resulting in net proceeds of approximately $6.7 million.

v3.23.2

Note 2 - Summary of Significant Accounting Policies	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Significant Accounting Policies [Text Block]	Note 2 - Summary of Significant Accounting Policies   Our unaudited condensed financial statements have been prepared in accordance with U.S. GAAP, and the requirements of the United States ("U.S.") Securities and Exchange Commission (the “SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. Accordingly, they do not include all of the information and footnotes normally included in financial statements prepared in conformity with U.S. GAAP. The December 31, 2022 condensed balance sheet was derived from the December 31, 2022 audited financial statements. They should be read in conjunction with the financial statements and notes thereto included in our 2022 Annual Report on Form 10-K, filed with the SEC on March 31, 2023 (the “Form 10-K”).   The accompanying condensed financial statements are unaudited and include all adjustments (consisting of normal recurring adjustments) that management considers necessary for a fair presentation of our condensed financial position and results of operations for the interim periods presented. The results of operations for the interim periods are not necessarily indicative of the results that may be expected for the entire year.   A summary of our significant accounting policies consistently applied in the preparation of the accompanying unaudited condensed financial statements follows.   Use of Estimates   The preparation of our unaudited condensed financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited condensed financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.   Cash and Cash Equivalents   We consider all highly liquid short-term investments with an initial maturity of three months or less to be cash equivalents. Any amounts of cash in financial institutions which exceed FDIC insured limits expose us to cash concentration risk. We have cash in a money market account and had $9,718,036 and $20,679,538 in excess of FDIC insured limits of $250,000 at June 30, 2023 and December 31, 2022, respectively. We have no cash equivalents at June 30, 2023 and December 31, 2022, respectively.   Net Loss Per Share   Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive shares of common stock, which includes common stock equivalents consisting of (i) 17,453,229 unexercised options granted by our board of directors and warrants to purchase shares of common stock, and (ii) 2,284,580 unvested restricted stock units to purchase shares of common stock granted by our board of directors.    Fair Value of Financial Instruments   The carrying amounts reported in the balance sheet for cash, money-market savings account, accounts receivable, and accounts payables approximate fair value because of the immediate or short-term maturity of these financial instruments.   Property and Equipment   Furniture and equipment are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets, which range from three to five years. Routine maintenance and repairs are charged to expense as incurred and major renovations or improvements are capitalized.   Research and Development Costs   Research and development expenditures consist of costs incurred to conduct research, develop engineering materials for further study, and develop clinical strategies for current and future programs. These costs include payments to collaborative research partners, manufacturing partners and consultants, and clinical strategy partners, wages and associated employee benefits, facilities, and overhead costs. These expenditures relate to our preclinical and Phase 1/2 clinical trials and are expensed as incurred. Materials produced to be used in clinical research are capitalized and included in research and development supplies and are expensed as they are used for testing or clinical activities, or have spoiled.   Research and development supplies purchased and capitalized for future use were $2,770,955 and $2,864,937 at June 30, 2023 and December 31, 2022, respectively.   Intellectual Property   Intellectual property consists of legal and related costs associated with patents and other proprietary technology and rights developed, acquired, licensed by, or maintained by us that we believe contribute to a probable economic benefit toward such patents and activities. These costs incurred in connection with obtaining and maintaining intellectual property protection, such as patent applications and patent maintenance, are capitalized. Intellectual property is stated at cost, to be amortized on a straight-line basis over the estimated useful lives of the assets.   Accounting for Stock-Based Compensation   We use the fair value-based method of accounting for stock-based compensation for options granted to employees, independent consultants and contractors. We measure options granted at fair value determined as of the grant date and recognize the expense over the periods in which the options vest or are expected to vest and related services are rendered based on the terms and conditions of the award. Generally, where the award only has a service condition, the requisite service period is the same as the vesting period.   Long-Lived Assets   We review long-lived assets and certain identifiable intangibles held and used for possible impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. In evaluating the fair value and future benefits of our intangible assets, management performs an analysis of the anticipated undiscounted future net cash flow of the individual assets over the remaining amortization period. We recognize an impairment loss if the carrying value of the asset exceeds the discounted expected future cash flows. During the six months ended June 30, 2023, and the year ended December 31, 2022, there were no deemed impairments of our long-lived assets.   Recent Accounting Developments   Accounting pronouncements issued but not effective until after June 30, 2023, are not expected to have a significant effect on our financial condition, results of operations, or cash flows.

v3.23.2

Note 3 - Intellectual Property	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Intangible Assets Disclosure [Text Block]	Note 3 - Intellectual Property   We own or have exclusive license agreements on 20 granted patents and 22 pending patent applications worldwide for technologies developed in-house or by researchers at the National Cancer Institute, MD Anderson, the University of Texas Southwestern Medical Center, and the University of Pittsburgh. These patents comprise various therapeutic, diagnostic, technical and processing claims. These license rights will be amortized on a straight-line basis over the estimated period of useful lives of the underlying patents or the license agreements.   University of Pittsburgh   On February 11, 2020, we entered into an exclusive license agreement with the University of Pittsburgh for patented gene therapy technologies relating to the potential treatment of Type 1 and Type 2 diabetes. This license was first amended on August 17, 2022, to extend the milestone related to the filing of a new investigational drug ("IND") application. This license was amended again on November 3, 2022, to include a new licensed glucagon promoter technology related to Type 1 diabetes and set FDA and clinical milestones related to the glucagon technology (See Note 7 – Commitments and Contingences – Commitments – University of Pittsburgh).   On November 22, 2022, we entered into an exclusive license agreement with the University of Pittsburgh relating to the transformation of macrophages enabling them to reduce autoimmunity activity in Type 1 diabetes.    On December 29, 2022, we entered into an exclusive license agreement with the University of Pittsburgh relating to the use of an insulin promoter in combination with our existing gene therapy, including the Pdx1 and MafA transcription factors, as a potential treatment for Type 2 diabetes.   See also "Note 9 – Subsequent Events" to our interim condensed financial statements included in this Quarterly Report on Form 10-Q regarding an additional exclusive license agreement that we entered into with the University of Pittsburgh in July 2023.   The University of Texas MD Anderson Cancer Center   On May 4, 2020, we entered into an exclusive worldwide license agreement with The Board of Regents of the University of Texas System on behalf of MD Anderson relating to a portfolio of patent applications and related technology for the treatment of cancer using our lead drug candidate and immunotherapies.

v3.23.2

Note 4 - Equity	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Equity [Text Block]	Note 4 - Equity   Registered Direct Offering   On March 1, 2023, we completed a registered direct offering, in which we sold to an accredited healthcare-focused institutional investor an aggregate of 3,809,524 shares of our common stock and warrants to purchase up to 3,809,524 shares of our common stock, at a combined offering price of $1.05 per share of common stock and accompanying warrant. The warrants are exercisable immediately upon issuance, expire 5 years from the date of issuance and have an exercise price of $1.10 per share. We received net proceeds of approximately $3.6 million after $400,000 of commissions and expenses, excluding any proceeds that may be received in the future from any exercise of the warrants.   See “Note 9 – Subsequent Events – July 2023 Registered Direct Offering” for a description of the Company’s registered direct offering of shares and warrants in July 2023 resulting in net proceeds of approximately $6.7 million.   At-The-Market Offering   On November 18, 2022, we entered into an Equity Distribution Agreement (the "Sales Agreement") with JMP Securities LLC ("JMP Securities") pursuant to which we  may sell from time to time, at our option, shares of our common stock through JMP Securities, as sales agent (the "ATM Facility"), up to an aggregate offering price of $50 million. Sales of the shares pursuant to the ATM Facility were previously made under our prior "shelf" Registration Statement on Form S-3 (Reg. No. 333-239134), and future ATM Facility sales may be made under our currently effective "shelf" Registration Statement on Form S-3 (Reg. No. 333-271386) and a related prospectus supplement for the ATM Facility to be filed as appropriate. Additionally, under the terms of the Sales Agreement, the shares may be sold at market prices, at negotiated prices or at prices related to the prevailing market price. We will pay JMP Securities a commission of 3.0% of the gross proceeds from the sale of the shares. During the year ended December 31, 2022, we sold 3,886 shares of common stock for aggregate net proceeds of $4,532 under the ATM Facility. We did not use the ATM Facility during the three months ended June 30, 2023, and during the six months ended June 30, 2023, we sold 53,592 shares of common stock for aggregate net proceeds of $78,355 under the ATM Facility.    Stock Issuances   During the three months ended June 30, 2023, we issued 5,000 shares of common stock for services provided to us valued at $4,400 to the Chairman of our Scientific Advisory Board. During the six months ended June 30, 2023, we issued 10,000 shares of common stock for services provided to us valued at $12,350 to the Chairman of our Scientific Advisory Board (inclusive of the 5,000 shares issued during the three months ended June 30, 2023, as described in the immediately preceding sentence). .   During the three months ended  June 30, 2022, we issued 5,000 shares of common stock for services provided to us valued at $11,150 to the Chairman of our Scientific Advisory Board. During the six months ended June 30, 2022, we issued (i) 10,000 shares of common stock for services provided to us valued at $28,650 to the Chairman of our Scientific Advisory Board (inclusive of the 5,000 shares issued during the three months ended June 30, 2022, as described in the immediately preceding sentence), and (ii) 13,643 shares of common stock upon the exercise of warrants on a cashless basis.   Preferred Stock   We are authorized to issue 10,000,000 shares of preferred stock with a par value of $0.001 per share, none of which are outstanding at June 30, 2023.   Common Stock   We are authorized to issue 200,000,000 shares of common stock with a par value of $0.001 per share, all of which are voting common stock. There were 51,979,078 shares of our common stock outstanding at June 30, 2023.   Common Stock Purchase Warrants   Common stock purchase warrant activity for the three and six months ended June 30, 2023, and  June 30, 2022, respectively, is as follows:       2023   2022     Number of   Weighted Average   Number of   Weighted Average     Warrants   Exercise Price   Warrants   Exercise Price Outstanding at January 1,   2,147,778   $ 4.32   2,204,747   $ 4.39 Warrants issued   3,839,524   1.10   —   — Warrants exercised   38,400   6.25   —   — Outstanding at March 31,   5,948,902   $ 2.23   2,204,747   $ 4.39 Warrants exercised   —   —   13,643   0.50 Warrants cancelled or expired   —   —   112,993   4.47 Outstanding at June 30,   5,948,902   $ 2.23   2,078,111   $ 4.41 Vested at June 30,   22,500   1.50   —   — Exercisable at June 30,   5,728,069   $ 2.23   1,844,776   $ 4.66   We did not issue any warrants during the three-month period ended June 30, 2023. During the six-month period ended June 30, 2023, we issued (i) a warrant to purchase up to 30,000 shares of common stock to a service provider at an exercise price of $1.65 per share, the fair market value of a share of common stock on the date of issuance, and (ii) a warrant to purchase up to 3,809,524 shares of common stock to the accredited healthcare-focused institutional investor in connection with the registered direct offering completed on March 1, 2023, at an exercise price of $1.10 per share. During the three- and six-month periods ended June 30, 2023, we recorded share-based compensation of $34,010 and $77,311, respectively, associated with the vesting and issuance of warrants. We expect to record $13,408 of share-based compensation for time-based vesting through the end of the fiscal year 2023 and $300,000 of share-based compensation based on performance-based vesting in the future with respect to our warrants outstanding as of June 30, 2023.   We did not issue any warrants during the three- or six-month periods ended  June 30, 2022. During the six-month period ended June 30, 2022, we issued 13,643 shares of common stock to a placement agent associated with a registered direct offering in November 2019 upon the exercise of warrants on a cashless basis and canceled warrants to purchase 112,993 shares of common stock upon termination of a warrant and warrant shares forfeited associated with a cashless exercise. We recorded no share-based compensation associated warrants during the six-month period ended June 30, 2022.   As of June 30, 2023, we had outstanding warrants to purchase 5,948,902 shares of common stock at a weighted average exercise price of $2.23 that have been issued to various consultants, investors, and placement agents. These warrants vest immediately or over periods ranging up to 12 months, are exercisable for a period of up to five years, enable the holders to purchase shares of our common stock at exercise prices ranging from $1.10 to $7.22 per share and have per-share fair values ranging from $0.60 to $4.63, based on Black-Scholes-Merton pricing models. The following assumptions were used in calculation of fair market value of options via Black-Scholes-Merton pricing models for the three and six months ended June 30, 2023:           Three Months Ended June 30, 2023   Six Months Ended June 30, 2023 Expected term (in years):       0   2.5 - 3.0 Risk-free rate:       0%   4.99% - 5.06% Volatility:       0.00%   83.14% Dividend yield:       0%   0%   2018 Equity Incentive Plan   Our board of directors and stockholders have approved and adopted our 2018 Equity Incentive Plan (“2018 Plan”), which became effective on the completion of our IPO on April 3, 2018. The 2018 Plan provides for the grant of incentive stock options that are intended to qualify under Section 422 of the Internal Revenue Code of 1986, as amended (“ISOs”), nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit ("RSU") awards, performance-based stock awards and performance-based cash awards. ISOs may be granted only to employees. All other awards may be granted to employees, including officers, and to our non-employee directors and consultants.   A total of 4,160,000 shares of common stock were initially available under the 2018 Plan, plus a number of shares of common stock (not to exceed 2,628,749 shares) subject to outstanding awards under our 2009 Equity Incentive Plan (the “2009 Plan”) as of the IPO that expire, are forfeited or otherwise terminate or that are used to cover the exercise price or applicable tax withholdings. No further grants will be made under the 2009 Plan.   In addition, the number of shares of common stock reserved for issuance under the 2018 Plan automatically increases on January 1 of each year, since  January 1, 2019, by 5% of the total number of shares of our common stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by our Board or a committee appointed to administer the 2018 Plan.   On  January 1, 2022 and 2023, the number of shares of common stock reserved for issuance under the 2018 Plan was increased by an aggregate of 2,393,735 and 2,405,298 shares, respectively. As of June 30, 2023, a total of 424,990 shares of common stock remain available for issuance under the 2018 Plan.   2018 Employee Stock Purchase Plan   Our board of directors and stockholders approved and adopted our 2018 Employee Stock Purchase Plan (“ESPP”), which became effective on April 3, 2018. The ESPP has not yet been utilized as a benefit available to our employees. The ESPP authorizes the issuance of 208,050 shares of our common stock pursuant to purchase rights that may be granted to our eligible employees. The number of shares of common stock reserved for issuance under the ESPP is automatically increased on January 1 of each calendar year, beginning on January 1, 2019, by 2% of the total number of shares of our common stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the administrator of the ESPP. The administrator of the ESPP determined not to increase the number of shares reserved for issuance under the ESPP on  January 1, 2023.   Stock Options   As of June 30, 2023, we had outstanding stock options to purchase 11,504,327 shares of common stock that have been granted to various executives, other employees, directors, and independent contractors. These options vest immediately or over periods ranging from 12 to 48 months, are exercisable for a period of up to ten years, enable the holders to purchase shares of our common stock at exercise prices ranging from $0.30 to $9.80 per share and have per-share fair values ranging from $0.24 to $7.93, based on Black-Scholes-Merton pricing models. The following assumptions were used in calculation of fair market value of options via Black-Scholes-Merton pricing models for the three months ended June 30, 2023:           Three Months Ended June 30, 2023   Six Months Ended June 30, 2023 Expected term (in years):       6.0   6.0 Risk-free rate:       4.60% – 4.73%   4.60% – 4.73% Volatility:       83.42%   83.14% - 83.42% Dividend yield:       0%   0%     During the three-month period ended  June 30, 2023, we granted stock options to purchase an aggregate of 47,500 shares of our common stock with exercise prices ranging from $0.81 to $0.88 per share to employees. During the six-month period ended  June 30, 2023, we granted stock options to purchase an aggregate of 130,000 shares of our common stock with exercise prices ranging from $0.81 to $1.51 per share to employees.   During the three-month period ended  June 30, 2022, we granted stock options to purchase an aggregate of 487,604 shares of our common stock with exercise prices ranging from $1.36 to $2.85 per share to board members, executives, other employees and consultants. During the six-month period ended June 30, 2022, we (i) granted stock options to purchase an aggregate of 2,892,166 shares of our common stock with exercise prices ranging from $1.36 to $3.50 per share to board members, executives, other employees and consultants, and (ii) cancelled options to purchase 17,500 shares of common stock at an exercise price of $2.00 in connection with the termination of certain employees.   The weighted average remaining contractual term for the outstanding options at  June 30, 2023 and  December 31, 2022 is 6.62 and 7.08 years, respectively.   Stock option activity for the six months ended June 30, 2023, and year ended  December 31, 2022 is as follows:         2023   2022     Number of   Weighted Average   Number of   Weighted Average     Options   Exercise Price   Options   Exercise Price Outstanding at January 1,   11,374,327   $ 3.08   8,574,301   $ 3.35 Options granted   82,500   1.43   2,404,562   2.30 Options expired or cancelled   —   —   17,500   2.00 Outstanding at March 31,   11,456,827   $ 3.07   10,961,363   $ 3.13 Options granted   47,500   0.85   487,604   1.59 Outstanding at June 30,   11,504,327   $ 3.06   11,448,967   $ 3.06 Vested at June 30,   582,981   2.02   235,465   3.32 Exercisable at June 30,   8,722,617   $ 3.16   6,166,620   $ 3.20   Restricted Stock Units   A summary of the RSU activity under the 2018 Plan during the six months ended June 30, 2023 is presented below. These amounts include RSUs granted to executives, other employees, and board members. There was no RSU activity for the year ended December 31, 2022.       2023     Number of   Weighted Average     Units   Grant Date Fair Value Outstanding at January 1,   —   — Restricted stock units granted   1,913,195   1.65 Outstanding at March 31,   1,913,195   $ 1.65 Restricted stock units granted   371,385   0.74 Outstanding at June 30,   2,284,580   $ 1.50 Vested at June 30,   —   — Expected to vest at June 30,   2,284,580   $ 1.50   Share-Based Compensation   For the three and six months ended June 30, 2023, our total share-based compensation was approximately $1.5 million and $2.9 million, respectively, nearly all of which represents the expected vesting of options issued to executives, other employees, and service providers and RSUs issued to executives, other employees, and board members. As of  June 30, 2023, our total compensation cost related to non-vested time-based stock option awards and warrants granted to executives, other employees, board members, and service providers and not yet recognized was approximately $7.3 million. We expect to record this stock-based compensation expense over the next three years using a graded vesting method. As of June 30, 2023, the weighted average term over which these expenses are expected to be recognized is 1.51 years.    For the three- and six-month periods ended June 30, 2022, our total share-based compensation was approximately $1.2 million and $2.2 million, respectively, nearly all of which represents the expected vesting of options issued to executives, other employees, and service providers.   As of June 30, 2023, there are no performance-based stock option awards outstanding and one performance-based warrant outstanding issued to a service provider. Our total compensation cost related to the non-vested performance-based warrant not yet recognized was approximately $300,000. The entirety of this warrant may be recognized and recorded upon the achievement of certain clinical milestones.

v3.23.2

Note 5 - 401(k) Savings Transactions	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Defined Contribution Plan [Text Block]	Note 5 - 401(k) Savings Plan   In 2022, we established a defined-contribution savings plan under Section 401(k) of the Internal Revenue Code ("401(k) Plan") and established an employer matching program for participants in the 401(k) Plan. The 401(k) Plan covers all employees who meet defined minimum age and service requirements, and allows participants to defer a portion of their annual compensation on a pre-tax basis. We incurred $27,758 and $90,806 of expense for matching contributions to the 401(k) Plan during the three- and six-month periods ended June 30, 2023, respectively. We incurred $22,048 and $25,752 of expense for matching contributions to the 401(k) Plan during the three- and six-month periods ended  June 30, 2022, respectively.

v3.23.2

Note 6 - Related Party Transactions	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Related Party Transactions Disclosure [Text Block]	Note 6 - Related Party Transactions   Introgen Research Institute   Introgen Research Institute (“IRI”) is a Texas-based technology company formed by Rodney Varner, our President, Chief Executive Officer and Chairman of the Board and IRI's sole officer. IRI is owned by trusts of which Mr. Varner's descendants are the sole beneficiaries. In April 2009, prior to Mr. Varner becoming an officer and director of our Company in August 2012, we entered into an Assignment and Collaboration Agreement with IRI, providing us with the exclusive right to commercialize a portfolio of intellectual property. This agreement was amended in 2011 to include additional sublicensing of additional intellectual property made available to IRI from MD Anderson (See Note 7 – Commitments and Contingences – Commitments – MD Anderson Cancer Center).

v3.23.2

Note 7 - Commitments and Contingencies	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Commitments and Contingencies Disclosure [Text Block]	Note 7 - Commitments and Contingencies   Commitments   MD Anderson Cancer Center   In July 2018, we entered into a two-year sponsored research agreement with MD Anderson to sponsor preclinical studies focused on the combination of REQORSA with an immunotherapy with a projected total cost of approximately $2 million. This agreement was extended beyond the original expiration date, expiring in May 2022 after giving effect to such extension. In August 2022, we entered into a three-year sponsored research agreement with MD Anderson to sponsor preclinical studies focused on REQORSA and NPRL2 in oncology to resensitize NSCLC and SCLC to targeted therapies and immunotherapies with a projected total cost of approximately $2.9 million. We incurred approximately $240,000 and $480,000 of expense from this agreement during the three- and six-month periods ended  June 30, 2023, respectively. We did not incur expenses from this agreement during the three- or six-month periods ended  June 30, 2022. As of June 30, 2023, we have paid approximately $720,000 toward this agreement.   In 2011, we agreed to assume certain contractual and other obligations of IRI in consideration for the sublicense rights, expertise, and assistance associated with certain technologies and intellectual property originally licensed to another party under the 1994 License Agreement with MD Anderson (“Original MD Anderson License Agreement”). These technologies and intellectual property were later sublicensed to IRI (the “IRI Sublicense”). We also agreed to pay royalties of 1% on sales of certain licensed products for a period of 21 years following the termination of the later of the Original MD Anderson License Agreement and the IRI Sublicense. We assumed patent prosecution costs and an annual minimum royalty of $20,000 payable to the National Institutes of Health.   On March 3, 2021, we entered into an amendment (the “MD License Amendment”) to the Patent and Technology License Agreement dated May 4, 2020, with MD Anderson. The MD License Amendment grants us a worldwide, exclusive, sublicensable license to an additional portfolio of six patents and one patent application and related technology for methods for treating cancer by administration of a TUSC2 therapy in conjunction with EGFR inhibitors or other anti-cancer therapies in patients predicted to be responsive to TUSC2 therapy. Pursuant to the MD License Amendment, we agreed to (i) pay annual maintenance fees ranging from the mid five figures to the low six figures, (ii) total milestone payments of $6,150,000, (iii) a one-time fee in the mid five figures and (iv) certain patent related expenses. We incurred $45,000 of expense from this agreement during each of the three- and six-month periods ended  June 30, 2023. We incurred $40,000 and $90,000 of expense from this agreement during the three- and six-month periods ended  June 30, 2022, respectively. As of June 30, 2023, we have paid approximately $320,000 toward this agreement.    National Institutes of Health   We have a royalty obligation to the National Institutes of Health ("NIH") to be paid upon our receipt of FDA approval using NIH technology. The $240,000 contingent obligation which increases annually by $20,000 and is $340,000 as of December 31, 2022, and June 30, 2023, and will be recognized when we obtain regulatory approval (the event that triggers the payment obligation).   University of Pittsburgh   Pursuant to an exclusive license agreement dated February 11, 2020 by and between us and the University of Pittsburgh, amended on August 17, 2022, and amended again on  November 3, 2022, we agreed to pay (i) an initial licensing fee of $25,000, (ii) annual maintenance fees of $25,000 for the first three years and $40,000 for each subsequent year following the first anniversary of the agreement, (iii) royalties ranging from 1.5% to 3% of net sales of licensed technologies, (iv) an annual minimal royalty payment of $250,000 per year beginning in the year of the first commercial sale of licensed technology, (v) a share of non-royalty sublicense income of 20%, and (vi) an aggregate of $3,975,000 in milestone payments related to the usage of a glucagon promoter and gene therapy technologies to potentially treat Type 1 diabetes. Unless earlier terminated pursuant to its terms, the agreement expires upon the later of (i) 20 years after the first commercial sale of the licensed technology thereunder and (ii) expiration of the last valid claim under the patent rights. We incurred $25,000 of expense from this agreement during each of the three- and six-month periods ended  June 30, 2023. We incurred $25,000 of expense from this agreement during each of the three- and six-month periods ended  June 30, 2022. As of June 30, 2023, we have incurred and paid approximately $110,000 toward this agreement.    Pursuant to an exclusive license agreement dated November 22, 2022 by and between us and the University of Pittsburgh, we agreed to pay (i) an initial licensing fee of $25,000, (ii) annual maintenance fees of $25,000 for the first three years and $40,000 for each subsequent year following the first anniversary of the agreement, (iii) royalties ranging from 1.5% to 3% of net sales of licensed technologies, (iv) an annual minimal royalty payment of $250,000 per year beginning in the year of the first commercial sale of licensed technology, (v) a share of non-royalty sublicense income of 20%, and (vi) an aggregate of $3,975,000 in milestone payments related to the usage of a macrophage technology and gene therapy technologies to potentially treat Type 1 diabetes. Unless earlier terminated pursuant to its terms, the agreement expires upon the later of (i) 20 years after the first commercial sale of the licensed technology thereunder and (ii) expiration of the last valid claim under the patent rights. We incurred $25,000 of expense from this agreement during each of the three- and six-month periods ended  June 30, 2023. We did not incur expenses from this agreement during the three- or six-month periods ended  June 30, 2022. As of June 30, 2023, we have incurred and paid approximately $25,000 toward this agreement.    Pursuant to an exclusive license agreement dated December 29, 2022 by and between us and the University of Pittsburgh, we agreed to pay (i) an initial licensing fee of $25,000, (ii) annual maintenance fees of $25,000 for the first three years and $40,000 for each subsequent year following the first anniversary of the agreement, (iii) royalties ranging from 1.5% to 3% of net sales of licensed technologies, (iv) an annual minimal royalty payment of $250,000 per year beginning in the year of the first commercial sale of licensed technology, (v) a share of non-royalty sublicense income of 20%, and (vi) an aggregate of $3,975,000 in milestone payments related to the usage of an insulin promoter and gene therapy technologies to potentially treat Type 2 diabetes. Unless earlier terminated pursuant to its terms, the agreement expires upon the later of (i) 20 years after the first commercial sale of the licensed technology thereunder and (ii) expiration of the last valid claim under the patent rights. We incurred $25,000 of expense from this agreement during each of the three- and six-month periods ended  June 30, 2023. We did not incur expenses from this agreement during the three- or six-month periods ended  June 30, 2022. As of June 30, 2023, we have paid approximately $25,000 toward this agreement.    Contract Development and Manufacturing Organization   We entered into a three-year development services agreement in July 2022, amended in each of January 2023 and March 2023, with a contract development and manufacturing organization to manufacture good manufacturing practices ("GMP") grade materials for use in our clinical trials with a projected total cost of approximately $4.5 million. We incurred approximately $2.3 million and $1.9 million of expense from this agreement during the three and six months ended  June 30, 2023, respectively. We did not incur expenses from this agreement during the three- or six-month periods ended  June 30, 2022. As of June 30, 2023, we have paid approximately $2.4 million toward this agreement.     Contingencies   From time to time, we may become subject to threatened and/or asserted claims arising in the ordinary course of our business. Management is not aware of any matters, either individually or in the aggregate, that are reasonably likely to have a material impact on our financial condition, results of operations or liquidity.

v3.23.2

Note 8 - Significant Events	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Effect of Covid 19 Pandemic [Text Block]	Note 8 - Significant Events   Effects of the COVID-19 pandemic are still being felt in the U.S. and around the world. The availability of vaccines holds promise for the future, though new variants of the virus and potential waning immunity from vaccines may result in continued impact from this pandemic in the future, which could adversely impact our operations. Through March 31, 2021, we had not experienced any material impact on its financial results or operations as a result of the COVID-19 pandemic. Beginning in June 2021, we experienced delays in engaging clinical sites as a result of a backlog of clinical trial protocols requiring review created by an accumulation of clinical trial protocols. We also have experienced disruptions in our supply chain regarding our manufacturing and testing operations. We continue to closely monitor the impact of the COVID-19 pandemic on its business and workforce.

v3.23.2

Note 9 - Subsequent Events	6 Months Ended
	Jun. 30, 2023
Notes to Financial Statements
Subsequent Events [Text Block]	Note 9 - Subsequent Events   Share Issuance   On July 3, 2023, we issued 5,000 shares of our common stock to the Chairman of our Scientific Advisory Board in consideration for services.   License Agreement   On July 14, 2023, we entered into an exclusive license agreement with the University of Pittsburgh related to a gene therapy for both Type 1 and Type 2 diabetes using a MafB promoter to drive expression of the Pdx1 and MafA transcription factors.    July 2023 Registered Direct Offering   On July 21, 2023, we completed a registered direct offering priced at the market under Nasdaq rules, in which we sold to accredited healthcare-focused institutional investors an aggregate of (i) 7,425,744 shares of our common stock, and (ii) warrants to purchase up to 7,425,744 shares of our common stock, at a combined offering price of $1.01 per share of common stock and accompanying warrant. The warrants are exercisable immediately upon issuance, expire 5 years from the date of issuance and have an exercise price of $0.885 per share.  Also, we agreed to issue to H.C. Wainwright & Co., LLC or its designees (the “Placement Agent”) warrants to purchase up to an aggregate of 445,545 shares of our common stock.  The warrants issued to the Placement Agent have substantially the same terms as the warrants issued to the investors except that the Placement Agent warrants have an exercise price of $1.2625 per share and expire on July 18, 2028. We received net proceeds of approximately $6.7 million after approximately $800,000 of commissions and expenses, excluding any proceeds that may be received in the future from any exercise of the warrants.   Warrant Issuances   On July 1, 2023, the Company issued a warrant to purchase up to 50,000 shares of its common stock at an exercise price of $0.95 per share to a consultant for services. On August 3, 2023, the Company issued a warrant to purchase up to 15,000 shares of its common stock at an exercise price of $0.73 per share to a consultant for services. On August 10, 2023, the Company issued a warrant to purchase up to 75,000 shares of its common stock at an exercise price of $0.64 per share to a consultant for services.   Option Exercise   On August 16, 2023, we issued 20,000 shares of common stock for $5,960 in cash to a former board member upon the exercise of options.

v3.23.2

Significant Accounting Policies (Policies)	6 Months Ended
	Jun. 30, 2023
Accounting Policies [Abstract]
Use of Estimates, Policy [Policy Text Block]	Use of Estimates   The preparation of our unaudited condensed financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited condensed financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.
Cash and Cash Equivalents, Policy [Policy Text Block]	Cash and Cash Equivalents   We consider all highly liquid short-term investments with an initial maturity of three months or less to be cash equivalents. Any amounts of cash in financial institutions which exceed FDIC insured limits expose us to cash concentration risk. We have cash in a money market account and had $9,718,036 and $20,679,538 in excess of FDIC insured limits of $250,000 at June 30, 2023 and December 31, 2022, respectively. We have no cash equivalents at June 30, 2023 and December 31, 2022, respectively.
Earnings Per Share, Policy [Policy Text Block]	Net Loss Per Share   Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive shares of common stock, which includes common stock equivalents consisting of (i) 17,453,229 unexercised options granted by our board of directors and warrants to purchase shares of common stock, and (ii) 2,284,580 unvested restricted stock units to purchase shares of common stock granted by our board of directors.
Fair Value of Financial Instruments, Policy [Policy Text Block]	Fair Value of Financial Instruments   The carrying amounts reported in the balance sheet for cash, money-market savings account, accounts receivable, and accounts payables approximate fair value because of the immediate or short-term maturity of these financial instruments.
Property, Plant and Equipment, Policy [Policy Text Block]	Property and Equipment   Furniture and equipment are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets, which range from three to five years. Routine maintenance and repairs are charged to expense as incurred and major renovations or improvements are capitalized.
Research and Development Expense, Policy [Policy Text Block]	Research and Development Costs   Research and development expenditures consist of costs incurred to conduct research, develop engineering materials for further study, and develop clinical strategies for current and future programs. These costs include payments to collaborative research partners, manufacturing partners and consultants, and clinical strategy partners, wages and associated employee benefits, facilities, and overhead costs. These expenditures relate to our preclinical and Phase 1/2 clinical trials and are expensed as incurred. Materials produced to be used in clinical research are capitalized and included in research and development supplies and are expensed as they are used for testing or clinical activities, or have spoiled.   Research and development supplies purchased and capitalized for future use were $2,770,955 and $2,864,937 at June 30, 2023 and December 31, 2022, respectively.
Intangible Assets, Finite-Lived, Policy [Policy Text Block]	Intellectual Property   Intellectual property consists of legal and related costs associated with patents and other proprietary technology and rights developed, acquired, licensed by, or maintained by us that we believe contribute to a probable economic benefit toward such patents and activities. These costs incurred in connection with obtaining and maintaining intellectual property protection, such as patent applications and patent maintenance, are capitalized. Intellectual property is stated at cost, to be amortized on a straight-line basis over the estimated useful lives of the assets.
Share-Based Payment Arrangement [Policy Text Block]	Accounting for Stock-Based Compensation   We use the fair value-based method of accounting for stock-based compensation for options granted to employees, independent consultants and contractors. We measure options granted at fair value determined as of the grant date and recognize the expense over the periods in which the options vest or are expected to vest and related services are rendered based on the terms and conditions of the award. Generally, where the award only has a service condition, the requisite service period is the same as the vesting period.
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block]	Long-Lived Assets   We review long-lived assets and certain identifiable intangibles held and used for possible impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. In evaluating the fair value and future benefits of our intangible assets, management performs an analysis of the anticipated undiscounted future net cash flow of the individual assets over the remaining amortization period. We recognize an impairment loss if the carrying value of the asset exceeds the discounted expected future cash flows. During the six months ended June 30, 2023, and the year ended December 31, 2022, there were no deemed impairments of our long-lived assets.
New Accounting Pronouncements, Policy [Policy Text Block]	Recent Accounting Developments   Accounting pronouncements issued but not effective until after June 30, 2023, are not expected to have a significant effect on our financial condition, results of operations, or cash flows.

v3.23.2

Note 4 - Equity (Tables)	6 Months Ended
	Jun. 30, 2023
Notes Tables
Schedule of Stockholders' Equity Note, Warrants or Rights [Table Text Block]	2023   2022     Number of   Weighted Average   Number of   Weighted Average     Warrants   Exercise Price   Warrants   Exercise Price Outstanding at January 1,   2,147,778   $ 4.32   2,204,747   $ 4.39 Warrants issued   3,839,524   1.10   —   — Warrants exercised   38,400   6.25   —   — Outstanding at March 31,   5,948,902   $ 2.23   2,204,747   $ 4.39 Warrants exercised   —   —   13,643   0.50 Warrants cancelled or expired   —   —   112,993   4.47 Outstanding at June 30,   5,948,902   $ 2.23   2,078,111   $ 4.41 Vested at June 30,   22,500   1.50   —   — Exercisable at June 30,   5,728,069   $ 2.23   1,844,776   $ 4.66
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block]	Three Months Ended June 30, 2023   Six Months Ended June 30, 2023 Expected term (in years):       0   2.5 - 3.0 Risk-free rate:       0%   4.99% - 5.06% Volatility:       0.00%   83.14% Dividend yield:       0%   0%         Three Months Ended June 30, 2023   Six Months Ended June 30, 2023 Expected term (in years):       6.0   6.0 Risk-free rate:       4.60% – 4.73%   4.60% – 4.73% Volatility:       83.42%   83.14% - 83.42% Dividend yield:       0%   0%
Share-Based Payment Arrangement, Option, Activity [Table Text Block]	2023   2022     Number of   Weighted Average   Number of   Weighted Average     Options   Exercise Price   Options   Exercise Price Outstanding at January 1,   11,374,327   $ 3.08   8,574,301   $ 3.35 Options granted   82,500   1.43   2,404,562   2.30 Options expired or cancelled   —   —   17,500   2.00 Outstanding at March 31,   11,456,827   $ 3.07   10,961,363   $ 3.13 Options granted   47,500   0.85   487,604   1.59 Outstanding at June 30,   11,504,327   $ 3.06   11,448,967   $ 3.06 Vested at June 30,   582,981   2.02   235,465   3.32 Exercisable at June 30,   8,722,617   $ 3.16   6,166,620   $ 3.20
Share-Based Payment Arrangement, Restricted Stock Unit, Activity [Table Text Block]	2023     Number of   Weighted Average     Units   Grant Date Fair Value Outstanding at January 1,   —   — Restricted stock units granted   1,913,195   1.65 Outstanding at March 31,   1,913,195   $ 1.65 Restricted stock units granted   371,385   0.74 Outstanding at June 30,   2,284,580   $ 1.50 Vested at June 30,   —   — Expected to vest at June 30,   2,284,580   $ 1.50

v3.23.2

Note 1 - Description of Business and Basis of Presentation (Details Textual) $ in Millions	Jul. 21, 2023 USD ($)
July 2023 Registered Direct Offering [Member] | Subsequent Event [Member]
Proceeds from Issuance or Sale of Equity	$ 6.7

v3.23.2

Note 2 - Summary of Significant Accounting Policies (Details Textual) - USD ($)	6 Months Ended	12 Months Ended
	Jun. 30, 2023	Dec. 31, 2022
Cash, Uninsured Amount	$ 9,718,036	$ 20,679,538
Cash Equivalents, at Carrying Value	0	0
Research and Development Assets, Current	2,770,955	2,864,937
Impairment, Long-Lived Asset, Held-for-Use, Total	$ 0	$ 0
Minimum [Member]
Property, Plant and Equipment, Useful Life (Year)	3 years
Maximum [Member]
Property, Plant and Equipment, Useful Life (Year)	5 years
Options and Warrants [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount (in shares)	17,453,229
Restricted Stock Units (RSUs) [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount (in shares)	2,284,580

v3.23.2

Note 4 - Equity (Details Textual) - USD ($)								3 Months Ended					6 Months Ended		12 Months Ended
	Jul. 21, 2023	Jul. 03, 2023	Mar. 01, 2023	Jan. 01, 2023	Nov. 18, 2022	Jan. 01, 2022	Apr. 03, 2018	Jun. 30, 2023	Mar. 31, 2023	Mar. 30, 2023	Jun. 30, 2022	Mar. 31, 2022	Jun. 30, 2023	Jun. 30, 2022	Dec. 31, 2022	Dec. 31, 2021
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)								5,948,902					5,948,902
Warrants and Rights Outstanding, Term (Year)								5 years					5 years
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)								$ 2.23	$ 2.23		$ 4.41	$ 4.39	$ 2.23	$ 4.41	$ 4.32	$ 4.39
Proceeds from Issuance of Common Stock													$ 4,080,780	$ 0
Stock Issued During Period, Value, Issued for Services								$ 4,400	$ 7,950		$ 17,972	$ 17,500
Stock Issued During Period, Shares, Exercise of Cashless Warrants (in shares)														13,643
Preferred Stock, Shares Authorized (in shares)							10,000,000	10,000,000					10,000,000		10,000,000
Preferred Stock, Par or Stated Value Per Share (in dollars per share)							$ 0.001	$ 0.001					$ 0.001		$ 0.001
Preferred Stock, Shares Outstanding, Ending Balance (in shares)								0					0		0
Common Stock, Shares Authorized (in shares)							200,000,000	200,000,000					200,000,000		200,000,000
Common Stock, Par or Stated Value Per Share (in dollars per share)							$ 0.001	$ 0.001					$ 0.001		$ 0.001
Common Stock, Shares, Outstanding (in shares)								51,979,078					51,979,078		48,105,962
Class of Warrant or Right, Issued in Period (in shares)								0	3,839,524		0			0
Class of Warrant or Right, Vesting Period (Month)													12 months
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number (in shares)								11,504,327		11,456,827	11,448,967	10,961,363	11,504,327	11,448,967	11,374,327	8,574,301
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period (Year)													10 years
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Exercise Price (in dollars per share)								$ 3.06		$ 3.07	$ 3.06	$ 3.13	$ 3.06	$ 3.06	$ 3.08	$ 3.35
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross (in shares)								47,500		82,500	487,604	2,404,562	130,000	2,892,166
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Grants in Period, Weighted Average Exercise Price (in dollars per share)								$ 0.85		$ 1.43	$ 1.59	$ 2.30
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Forfeitures and Expirations in Period (in shares)												17,500		17,500
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Forfeitures and Expirations in Period, Weighted Average Exercise Price (in dollars per share)												$ 2.00		$ 2.00
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term (Year)													6 years 7 months 13 days		7 years 29 days
Class of Warrant or Right, Outstanding (in shares)								5,948,902	5,948,902		2,078,111	2,204,747	5,948,902	2,078,111	2,147,778	2,204,747
The 2018 Equity Incentive Plan [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Additional Shares Authorized (in shares)				2,405,298		2,393,735	4,160,000
Share Based Compensation Arrangement By Share Based Payment Award, Percentage Applied on Outstanding Shares of Common Stock For Automatically Increase on Each Year							5.00%
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares)								424,990					424,990
The 2009 Plan [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Additional Shares Authorized (in shares)							2,628,749
The 2018 Employee Stock Purchase Plan [Member]
Share Based Compensation Arrangement By Share Based Payment Award, Percentage Applied on Outstanding Shares of Common Stock For Automatically Increase on Each Year							2.00%
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares)							208,050
Time Based Options [Member]
Share-based Payment Arrangement, Expense, Future Milestone													$ 13,408	$ 0
Performance Shares [Member]
Share-based Payment Arrangement, Expense, Future Milestone													$ 300,000
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number (in shares)								0					0
Share-Based Payment Arrangement, Option [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested in Period, Fair Value								$ 1,500,000			$ 1,200,000		$ 2,900,000	$ 2,200,000
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount								$ 7,300,000					$ 7,300,000
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year)													1 year 6 months 3 days
Scientific Advisory Board Chairman [Member]
Stock Issued During Period, Shares, Issued for Services (in shares)								5,000			5,000		10,000	10,000
Stock Issued During Period, Value, Issued for Services								$ 4,400			$ 11,150		$ 12,350	$ 28,650
Maximum [Member]
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)								$ 7.22					$ 7.22
Warrants or Rights, Fair Value Per Share (in dollars per share)								4.63					$ 4.63
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period (Month)													48 months
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Exercise Price (in dollars per share)								9.80					$ 9.80
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Weighted Average Grant Date Fair Value (in dollars per share)													7.93
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Grants in Period, Weighted Average Exercise Price (in dollars per share)								0.88			$ 2.85		1.51	$ 3.50
Weighted Average [Member]
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)								2.23					2.23
Minimum [Member]
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)								1.10					1.10
Warrants or Rights, Fair Value Per Share (in dollars per share)								0.60					$ 0.60
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period (Month)													12 months
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Exercise Price (in dollars per share)								0.30					$ 0.30
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Weighted Average Grant Date Fair Value (in dollars per share)													0.24
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Grants in Period, Weighted Average Exercise Price (in dollars per share)								$ 0.81			$ 1.36		$ 0.81	$ 1.36
Subsequent Event [Member] | Scientific Advisory Board Chairman [Member]
Stock Issued During Period, Shares, Issued for Services (in shares)		5,000
Warrants Issued with Registered Direct Offering [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)			3,809,524
Warrants and Rights Outstanding, Term (Year)			5 years
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)			$ 1.10
Warrants Issued with Registered Direct Offering [Member] | Subsequent Event [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)	7,425,744
Warrants and Rights Outstanding, Term (Year)	5 years
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)	$ 0.885
Warrant For Service Provider [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)								30,000					30,000
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)								$ 1.65					$ 1.65
Warrant For Service Provider 2 [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)								3,809,524					3,809,524
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)								$ 1.10					$ 1.10
Vesting of Warrants For Service Provider [Member]
Share-Based Payment Arrangement, Expense								$ 34,010					$ 77,311	$ 112,993
Performance-based Warrant [Member]
Class of Warrant or Right, Outstanding (in shares)								1					1
Warrant, Nonvested Award, Cost Not yet Recognized, Amount								$ 300,000					$ 300,000
Registered Direct Offering [Member]
Stock Issued During Period, Shares, New Issues (in shares)			3,809,524
Equity Offering, Combined Purchase Price (in dollars per share)			$ 1.05
Proceeds from Issuance or Sale of Equity			$ 3,600,000
Payments of Stock Issuance Costs			$ 400,000
July 2023 Registered Direct Offering [Member] | Subsequent Event [Member]
Stock Issued During Period, Shares, New Issues (in shares)	7,425,744
Proceeds from Issuance or Sale of Equity	$ 6,700,000
Payments of Stock Issuance Costs	$ 800,000
The 2022 ATM Facility [Member]
Stock Issued During Period, Shares, New Issues (in shares)					3,886			0					53,592
Brokerage Commissions, Percentage of Gross Proceeds					3.00%
Proceeds from Issuance of Common Stock					$ 4,532								$ 78,355
The 2022 ATM Facility [Member] | Maximum [Member]
Common Stock, Shares Authorized, Value					$ 50,000,000

v3.23.2

Note 4 - Equity - Common Stock Purchase Warrant Activity (Details) - $ / shares	3 Months Ended				6 Months Ended
	Jun. 30, 2023	Mar. 31, 2023	Jun. 30, 2022	Mar. 31, 2022	Jun. 30, 2022
Outstanding, number of warrants (in shares)	5,948,902	2,147,778	2,204,747	2,204,747	2,204,747
Outstanding, weighted average exercise price (in dollars per share)	$ 2.23	$ 4.32	$ 4.39	$ 4.39	$ 4.39
Warrants issued, number of warrants (in shares)	0	3,839,524	0		0
Warrants issued, weighted average exercise price (in dollars per share)		$ 1.10
Exercised, number of warrants (in shares)		38,400	13,643
Exercised, weighted average exercise price (in dollars per share)		$ 6.25	$ 0.50
Warrants cancelled or expired, number of warrants (in shares)			112,993
Warrants cancelled or expired, weighted average exercise price (in dollars per share)			$ 4.47
Outstanding, number of warrants (in shares)	5,948,902	5,948,902	2,078,111	2,204,747	2,078,111
Outstanding, weighted average exercise price (in dollars per share)	$ 2.23	$ 2.23	$ 4.41	$ 4.39	$ 4.41
Vested, number of warrants (in shares)	22,500
Vested, weighted average exercise price (in dollars per share)	$ 1.50
Exercisable, number of warrants (in shares)	5,728,069		1,844,776		1,844,776
Exercisable, weighted average exercise price (in dollars per share)	$ 2.23		$ 4.66		$ 4.66

v3.23.2

Note 4 - Equity - Assumptions (Details)	3 Months Ended	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2023
Expected term (in years): (Year)	0 years
Risk-free rate:	0.00%
Volatility:	0.00%	83.14%
Dividend yield:	0.00%	0.00%
Share-Based Payment Arrangement, Option [Member]
Expected term (in years): (Year)	6 years	6 years
Volatility:	83.42%
Dividend yield:	0.00%	0.00%
Minimum [Member]
Expected term (in years): (Year)		2 years 6 months
Risk-free rate:		4.99%
Minimum [Member] | Share-Based Payment Arrangement, Option [Member]
Risk-free rate:	4.60%	4.60%
Volatility:		83.14%
Maximum [Member]
Expected term (in years): (Year)		3 years
Risk-free rate:		5.06%
Maximum [Member] | Share-Based Payment Arrangement, Option [Member]
Risk-free rate:	4.73%	4.73%
Volatility:		83.42%

v3.23.2

Note 4 - Equity - Stock Option Activity (Details) - $ / shares	3 Months Ended				6 Months Ended
	Jun. 30, 2023	Mar. 30, 2023	Jun. 30, 2022	Mar. 31, 2022	Jun. 30, 2023	Jun. 30, 2022
Outstanding, number of shares (in shares)		11,374,327	10,961,363	8,574,301	11,374,327	8,574,301
Outstanding, weighted average exercise price (in dollars per share)		$ 3.08	$ 3.13	$ 3.35	$ 3.08	$ 3.35
Options granted, number of shares (in shares)	47,500	82,500	487,604	2,404,562	130,000	2,892,166
Options granted, weighted average exercise price (in dollars per share)	$ 0.85	$ 1.43	$ 1.59	$ 2.30
Options expired or cancelled, number of shares (in shares)				17,500		17,500
Options expired or cancelled, weighted average exercise price (in dollars per share)				$ 2.00		$ 2.00
Outstanding, number of shares (in shares)	11,504,327	11,456,827	11,448,967	10,961,363	11,504,327	11,448,967
Outstanding, weighted average exercise price (in dollars per share)	$ 3.06	$ 3.07	$ 3.06	$ 3.13	$ 3.06	$ 3.06
Vested or expected to vest, number of shares (in shares)	582,981		235,465		582,981	235,465
Vested or expected to vest, weighted average exercise price (in dollars per share)	$ 2.02		$ 3.32		$ 2.02	$ 3.32
Exercisable, number of shares (in shares)	8,722,617		6,166,620		8,722,617	6,166,620
Exercisable, weighted average exercise price (in dollars per share)	$ 3.16		$ 3.20		$ 3.16	$ 3.20

v3.23.2

Note 4 - Equity - Restricted Stock Units Activity (Details) - Restricted Stock Units (RSUs) [Member] - $ / shares	3 Months Ended
	Jun. 30, 2023	Mar. 31, 2023
Outstanding, shares (in shares)	1,913,195
Outstanding, weighted average grant date fair value (in dollars per share)	$ 1.65
Restricted stock units granted, shares (in shares)	371,385	1,913,195
Restricted stock units granted, weighted average grant date fair value (in dollars per share)	$ 0.74	$ 1.65
Outstanding, shares (in shares)	2,284,580	1,913,195
Outstanding, weighted average grant date fair value (in dollars per share)	$ 1.50	$ 1.65
Expected to vest at June 30, (in shares)	2,284,580
Expected to vest at June 30, (in dollars per share)	$ 1.50

v3.23.2

Note 5 - 401(k) Savings Transactions (Details Textual) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Defined Contribution Plan, Cost	$ 27,758	$ 22,048	$ 90,806	$ 25,752

v3.23.2

Note 7 - Commitments and Contingencies (Details Textual) - USD ($)		1 Months Ended	3 Months Ended			6 Months Ended		12 Months Ended
	Sep. 30, 2022	Jul. 31, 2018	Jun. 30, 2023	Jun. 30, 2022	Mar. 31, 2017	Jun. 30, 2023	Jun. 30, 2022	Dec. 31, 2009	Mar. 31, 2023	Dec. 31, 2022	Dec. 29, 2022	Nov. 22, 2022	Mar. 03, 2021	Feb. 11, 2020
Costs and Expenses			$ 8,035,744	$ 5,770,387		$ 17,306,988	$ 11,081,083
Other Commitment, Total										$ 340,000
License Agreement Terms [Member]
Costs and Expenses			45,000	40,000		45,000	90,000
Contract Payments Incurred and Paid						320,000
License Agreement Milestone Payment													$ 6,150,000
National Institute of Health [Member]
Royalty on Sales, Percentage								1.00%
Royalty Term (Year)								21 years
Royalty Payment, Annual Minimum								$ 20,000
Payment for Contingent Consideration Liability, Operating Activities					$ 240,000
Contingent Payments Annual Increase					$ 20,000
Research Agreement [Member] | MD Anderson [Member]
Long Term Contract, Estimated Cost	$ 2,900,000	$ 2,000,000
Costs and Expenses			240,000	0		480,000	0
Contract Payments Incurred and Paid						720,000
License Agreement [Member] | University of Pittsburgh [Member]
Licensing Fee, Amount														$ 25,000
Annual Maintenance Fee, First Three Years, Amount														25,000
Annual Maintenance Fee, After Year Three, Amount														40,000
Annual Royalty Payment Per Year, Minimum														$ 250,000
Share of Non-Royalty Sublicense Income, Percent														20.00%
License Agreement [Member] | University of Pittsburgh [Member] | Dosing of First Human Patient in a Phase I Clinical Trial [Member]
Costs and Expenses			25,000	25,000		25,000	25,000
Contract Payments Incurred and Paid						110,000
Milestone Payment														$ 3,975,000
License Agreement [Member] | University of Pittsburgh [Member] | Usage of a Glucagon Promoter and Gene Therapy Technologies to Potentially Treat Type 1 Diabetes [Member]
Costs and Expenses			25,000	0		25,000	0
Contract Payments Incurred and Paid						25,000
Licensing Fee, Amount												$ 25,000
Annual Maintenance Fee, First Three Years, Amount												25,000
Annual Maintenance Fee, After Year Three, Amount												40,000
Annual Royalty Payment Per Year, Minimum												$ 250,000
Share of Non-Royalty Sublicense Income, Percent												20.00%
Milestone Payment												$ 3,975,000
License Agreement [Member] | University of Pittsburgh [Member] | Usage of a Glucagon Promoter and Gene Therapy Technologies to Potentially Treat Type 2 Diabetes [Member]
Costs and Expenses			25,000	0			0
Contract Payments Incurred and Paid						25,000
Licensing Fee, Amount											$ 25,000
Annual Maintenance Fee, First Three Years, Amount											25,000
Annual Maintenance Fee, After Year Three, Amount											40,000
Annual Royalty Payment Per Year, Minimum											$ 250,000
Share of Non-Royalty Sublicense Income, Percent											20.00%
Milestone Payment											$ 3,975,000
License Agreement [Member] | University of Pittsburgh [Member] | Minimum [Member]
Royalty Percent, Licensed Technology Covered by Patent														1.50%
License Agreement [Member] | University of Pittsburgh [Member] | Minimum [Member] | Usage of a Glucagon Promoter and Gene Therapy Technologies to Potentially Treat Type 1 Diabetes [Member]
Royalty Percent, Licensed Technology Covered by Patent												1.50%
License Agreement [Member] | University of Pittsburgh [Member] | Minimum [Member] | Usage of a Glucagon Promoter and Gene Therapy Technologies to Potentially Treat Type 2 Diabetes [Member]
Royalty Percent, Licensed Technology Covered by Patent											1.50%
License Agreement [Member] | University of Pittsburgh [Member] | Maximum [Member]
Royalty Percent, Licensed Technology Covered by Patent														3.00%
License Agreement [Member] | University of Pittsburgh [Member] | Maximum [Member] | Usage of a Glucagon Promoter and Gene Therapy Technologies to Potentially Treat Type 1 Diabetes [Member]
Royalty Percent, Licensed Technology Covered by Patent												3.00%
License Agreement [Member] | University of Pittsburgh [Member] | Maximum [Member] | Usage of a Glucagon Promoter and Gene Therapy Technologies to Potentially Treat Type 2 Diabetes [Member]
Royalty Percent, Licensed Technology Covered by Patent											3.00%
Development and Manufacturing of GMP Grade Materials [Member]
Costs and Expenses			$ 2,300,000	$ 0		1,900,000	$ 0
Contract Payments Incurred and Paid						$ 2,400,000
Development Services Agreement, Expected Total Project Cost									$ 4,500,000

v3.23.2

Note 9 - Subsequent Events (Details Textual) - USD ($)				3 Months Ended		6 Months Ended
	Aug. 16, 2023	Jul. 21, 2023	Jul. 03, 2023	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022	Aug. 10, 2023	Aug. 03, 2023	Jul. 01, 2023	Mar. 31, 2023	Mar. 01, 2023	Dec. 31, 2022	Mar. 31, 2022	Dec. 31, 2021
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)				5,948,902		5,948,902
Warrants and Rights Outstanding, Term (Year)				5 years		5 years
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)				$ 2.23	$ 4.41	$ 2.23	$ 4.41				$ 2.23		$ 4.32	$ 4.39	$ 4.39
Warrants Issued with Registered Direct Offering [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)												3,809,524
Warrants and Rights Outstanding, Term (Year)												5 years
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)												$ 1.10
Scientific Advisory Board Chairman [Member]
Stock Issued During Period, Shares, Issued for Services (in shares)				5,000	5,000	10,000	10,000
Subsequent Event [Member] | Warrants Issued with Registered Direct Offering [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)		7,425,744
Warrants and Rights Outstanding, Term (Year)		5 years
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)		$ 0.885
Subsequent Event [Member] | Placement Agent Warrants [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)		445,545
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)		$ 1.2625
Subsequent Event [Member] | Consultant Warrants [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)								75,000	15,000	50,000
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)								$ 0.64	$ 0.73	$ 0.95
Subsequent Event [Member] | July 2023 Registered Direct Offering [Member]
Stock Issued During Period, Shares, New Issues (in shares)		7,425,744
Shares Issued, Price Per Share (in dollars per share)		$ 1.01
Proceeds from Issuance or Sale of Equity		$ 6,700,000
Payments of Stock Issuance Costs		$ 800,000
Subsequent Event [Member] | Scientific Advisory Board Chairman [Member]
Stock Issued During Period, Shares, Issued for Services (in shares)			5,000
Subsequent Event [Member] | Former Board Member [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period (in shares)	20,000
Stock Issued During Period, Value, Stock Options Exercised	$ 5,960

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