Notes
to Consolidated Financial Statements
Note
1 - Basis of presentation
Galmed
Pharmaceuticals Ltd. (the “Company”) was incorporated in Israel on July 31, 2013 and commenced operations on February 2,
2014.
The
Company holds a wholly-owned subsidiary, Galmed International Ltd., which was incorporated in Malta. Galmed International Ltd. previously
held a wholly-owned subsidiary, Galmed Medical Research Ltd., which was incorporated in Israel, and had been an inactive company since
2015 and was liquidated in February 2019.
The
Company also holds two additional wholly-owned subsidiaries, Galmed Research and Development Ltd and Galtopa Therapeutics Ltd., both
of which are incorporated in Israel.
The
Company is a clinical stage biopharmaceutical company primarily focused on the development of its product candidate Aramchol for
liver and fibro-inflammatory diseases. The Company has focused almost exclusively on developing Aramchol for the treatment of NASH
and is currently developing Aramchol for PSC and exploring the feasibility of developing Aramchol for other fibro-inflammatory
indications outside of liver disease. The Company is also collaborating with the Hebrew University in the development of
Amilo-5MER. The Company has an operating history limited to pre-clinical and clinical drug development.
In
May 2023, the Company announced the initiation of a new clinical program to evaluate Aramchol meglumine for the treatment of Primary
Sclerosing Cholangitis (PSC).
In
addition, in May 2023, the Company entered into a definitive agreement with OnKai, Inc. (“Onkai”) for an equity investment
in Onkai. See note 4.
The
Company funded its research and development programs and operations to date primarily through proceeds from private placements and public
offerings. The Company currently has no products approved for marketing and has not generated any revenue from product sales to date.
As of March 31, 2023, the Company had cash and cash equivalents of $1.7 million, short term deposit of $0.8 million, restricted cash
of $0.1 million, and marketable debt securities of $9.7 million.
The
Company has incurred operating losses in each year since inception. The Company’s loss attributable to holders of its ordinary
shares for the three months period ended March 31, 2023 was approximately $1.8 million. As of March 31, 2023, the Company had
an accumulated deficit of $187.9 million. Substantially all of its operating losses resulted from costs incurred in connection with the
Company’s development program and from general and administrative costs associated with its operations.
The
Company will need to raise substantial, additional capital to fund its operations and to develop Aramchol for, and beyond its current
development stage and any future commercialization, as well as any additional indications.
Based
on the Company’s current operating plan, the Company’s management currently estimates that its cash position will support
its current clinical trials and operations as currently conducted for more than 12 months from the date of issuance of these financial
statements.
These
unaudited interim consolidated financial statements have been prepared as of March 31, 2023 and for the three months period then ended.
Accordingly, certain information and footnote disclosures normally included in annual financial statements prepared in accordance with
U.S. GAAP have been omitted. These unaudited interim consolidated financial statements should be read in conjunction with the audited
financial statements and the accompanying notes of the Company for the year ended December 31, 2022 that are included in the Company’s
Annual Report on Form 20-F, filed with the Securities and Exchange Commission on March 29, 2023 (the “Annual Report on Form 20-F”).
The results of operations presented are not necessarily indicative of the results to be expected for the year ending December 31, 2023.
Note
2 - Summary of significant accounting policies
The
significant accounting policies that have been applied in the preparation of the unaudited consolidated interim financial statements
are identical to those that were applied in preparation of the Company’s most recent annual financial statements in connection
with its Annual Report on Form 20-F.
Note
3 - Stockholders’ Equity
|
1. |
In
February 2022, the Company granted options to purchase 24 ordinary shares of the Company to one of its officers. The options
are exercisable at $1.61 per share, have a 10-year term and vest over a period of four years. |
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2. |
In
November 2022, the Company’s board of directors approved the repricing of outstanding options to purchase an aggregate
of 64,559 ordinary shares held by the Company’s employees and directors to $5.70 per share and extended their
terms for one year following the date of termination of an optionee’s employment or service with the Company or affiliate.
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On March 23,
2023, the Company received a ruling from the Israel Tax Authority (“ITA”) confirming the repricing. This repricing was
accounted for as a modification of a share-based payment award and increased the. The incremental compensation expense recognized
as a result of the modification during the period ended December 31, 2023 was approximately $0.1 million. |
Note
4 – Subsequent events
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1. |
On
May 4, 2023, the Company entered into a definitive agreement (the “Agreement”) for a $1.5 million equity investment
in OnKai, a US-based technology company developing an AI-based platform to advance healthcare for underserved populations across
the United States by facilitating alignment between healthcare stakeholders. |
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The
Agreement provides that the Company will invest $1.5 million in exchange for series seed preferred shares of OnKai (which is in addition
to a $1.5 million investment that was made by the Company in OnKai through a Simple Agreement for future equity and which
will convert at a 15% discount into series seed preferred shares upon consummation of the Investment Round). Following the Investment
Round, the Company will hold approximately 18% of the outstanding share capital of OnKai on an as-converted and fully diluted basis. |
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2. |
On
May 15, 2023 the Company effected a reverse share split of the Company’s ordinary shares at the ratio of 1-for-15, such that
each fifteen (15) ordinary shares, par value NIS 0.01 per share, shall be consolidated into one (1) ordinary share, par value NIS
0.15. As a result, all share and per share amounts were adjusted retroactively for all periods presented in these financial statements. |
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
All
references to “we,” “us,” “our,” “the Company” and “our Company”, in this
Form 6-K are to Galmed Pharmaceuticals Ltd. and its subsidiaries, unless the context otherwise requires. All references to “shares”
or “ordinary shares” are to our ordinary shares, NIS 0.01 nominal par value per share. All references to “Israel”
are to the State of Israel. “U.S. GAAP” means the generally accepted accounting principles of the United States. Unless otherwise
stated, all of our financial information presented in this Form 6-K has been prepared in accordance with U.S. GAAP. Any discrepancies
in any table between totals and sums of the amounts and percentages listed are due to rounding. Unless otherwise indicated, or the context
otherwise requires, references in this Form 6-K to financial and operational data for a particular year refer to the fiscal year of our
company ended December 31 of that year.
Our
reporting currency and financial currency is the U.S. dollar. In this Form 6-K, “NIS” means New Israeli Shekel, and “$,”
“US$” and “U.S. dollars” mean United States dollars.
Cautionary
Note Regarding Forward-Looking Statements
This
Form 6-K contains forward-looking statements about our expectations, beliefs or intentions regarding, among other things, our product
development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, we
or our representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified
by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,”
“should,” “anticipate,” “could,” “might,” “seek,” “target,” “will,”
“project,” “forecast,” “continue” or their negatives or variations of these words or other comparable
words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements may be included
in, among other things, various filings made by us with the SEC, press releases or oral statements made by or with the approval of one
of our authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results
as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently
subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied
by the forward-looking statements. Many factors could cause our actual activities or results to differ materially from the activities
and results anticipated in forward-looking statements, including, but not limited to, the factors summarized below:
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the
timing and cost of our planned PSC clinical trial and our pivotal Phase 3 ARMOR trial, or the ARMOR Study, if re-initiated, for our
product candidates, Aramchol and Amilo-5MER, or for any other pre-clinical or clinical trials; |
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completion
and receiving favorable results of our planned PSC clinical trial and the ARMOR Study (if re-initiated) for Aramchol or any other
pre-clinical or clinical trial; |
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regulatory
action with respect to Aramchol or any other product candidate by the U.S. Food and Drug Administration, or the FDA, or the European
Medicines Authority, or EMA, including but not limited to acceptance of an application for marketing authorization, review and approval
of such application, and, if approved, the scope of the approved indication and labeling; |
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the
commercial launch and future sales of Aramchol and any future product candidates; |
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our
ability to comply with all applicable post-market regulatory requirements for Aramchol, Amilo-5MER or any other product candidate
in the countries in which we seek to market the product; |
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our
ability to achieve favorable pricing for Aramchol, Amilo-5MER or any other product candidate; |
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our
expectations regarding the commercial market for PSC, non-alcoholic steato-hepatitis, or NASH, in patients or any other targeted
indication; |
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third-party
payor reimbursement for Aramchol, Amilo-5MER or any other product candidate; |
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our
estimates regarding anticipated capital requirements and our needs for additional financing; |
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market
adoption of Aramchol or any other product candidate by physicians and patients; |
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the
timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate; |
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our
ability to obtain and maintain adequate protection of our intellectual property; |
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the
possibility that we may face third-party claims of intellectual property infringement; |
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our
ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; |
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our
ability to establish adequate sales, marketing and distribution channels; |
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intense
competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory
and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; |
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the
development and approval of the use of Aramchol or any other product candidate for additional indications or in combination therapy; |
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our
expectations regarding licensing, acquisitions and strategic operations; |
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current
or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated
liquidity risk; and |
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our
ability to maintain the listing of our ordinary share on The Nasdaq Capital Market; |
We
believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known
and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance
or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in
our Annual Report on Form 20-F for the year ended December 31, 2022 filed with the SEC on March 29, 2023, in greater detail under the
heading “Risk Factors” and elsewhere in the Annual Report and this Form 6-K. Given these uncertainties, you should not rely
upon forward-looking statements as predictions of future events.
All
forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified
in their entirety by the cautionary statements included in this report. We undertake no obligations to update or revise forward-looking
statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In
evaluating forward-looking statements, you should consider these risks and uncertainties.
Overview
We
are a biopharmaceutical company focused on the development of Aramchol. We have focused almost exclusively on developing Aramchol
for the treatment of liver disease and are currently developing Aramchol for PSC and exploring the feasibility of developing
Aramchol for other fibro-inflammatory indications outside of liver disease. We are also collaborating with the Hebrew University
in the development of Amilo-5MER, a 5 amino acid synthetic peptide.
In
September 2019, we initiated our Phase 3 ARMOR Study to evaluate the efficacy and safety of Aramchol in subjects with NASH and fibrosis.
The ARMOR Study was originally comprised of two parts, a randomized, double-blind, placebo-controlled histology-based registrational
part and a clinically based part where subjects will continue with the same treatment for approximately five years. In December 2020,
we announced the addition of a 150-patient open label part to the ARMOR Study and suspended randomization of new patients into the double-blind,
placebo-controlled histology-based registrational part of ARMOR as all enrolled patients were transitioned to the open
label part.
In
May 2022, we announced our plan to expand into new anti-fibrotic indications to maximize the potential of Aramchol while at the same
time discontinuing the open label part of its ARMOR Study having reached its objectives. Simultaneously, we initiated a cost reduction
plan and initiated a process to evaluate our strategic alternatives. Following the discontinuation of our open label part of the ARMOR
Study, we do not currently expect to initiate the second part of the ARMOR Study in the near term.
In
May, 2023, we announced the initiation of a new clinical program to evaluate Aramchol meglumine for the treatment of Primary Sclerosing
Cholangitis (PSC), a rare disease for which there is no approved treatment. We plan to initiate a Phase 2 study in the last quarter
of 2023. The single-arm, open label, proof-of-concept clinical trial will evaluate the effects of 24 weeks of treatment with Aramchol
meglumine in approximately 15 patients with PSC. The study’s endpoints will include the conventional relevant laboratory parameters
(alkaline phosphatase and bilirubin), sophisticated imaging including liver stiffness using MR Elastography (MRE), imaging of the biliary
tract using MR cholangiopancreatography (MRCP) and hepatocyte-specific contrast agents, histological fibrosis and molecular assessment
as well as a range of biomarkers of disease activity and fibrosis. These endpoints are expected to provide a robust assessment of the
underlying disease and the effects of Aramchol.
In
addition, in May 2023, we entered into a definitive agreement (the “Agreement”) for a $1.5 million equity investment in OnKai
Inc. (“OnKai”), a US-based technology company developing an AI-based platform to advance healthcare for underserved populations
across the United States by facilitating alignment between healthcare stakeholders. The signing of the definitive agreement follows an
announcement that we made in January 2023 that we had entered into a non-binding termsheet for an equity investment in OnKai. The Agreement
provides that we will invest $1.5 million in exchange for series seed preferred shares of OnKai (which is in addition to a $1.5 million
investment that was made by the Company in OnKai through a Simple Agreement for Future Equity and which will convert at a 15% discount
into series seed preferred shares upon consummation of the Investment Round). Following the Investment Round, we will hold approximately
18% of the outstanding share capital of OnKai on an as-converted and fully diluted basis. In connection with the Agreement, the our wholly-owned
subsidiary, Galmed Research and Development Ltd. (“GRD”), entered into a services agreement (the “Services Agreement”)
with OnKai. The Services Agreement provides that GRD shall on a non-exclusive basis (i) provide support services to OnKai relating to
finance, business development, strategic planning, execution and others; and (ii) lend its experience to OnKai in building a strategy
and for the development of treatments for the underserved and that OnKai shall on a non-exclusive basis (i) take part in plan preparation
to serve GDR’s vision of developing drugs for the underserved population and (ii) when relevant, design a process on the clinical
trial dashboard that could potentially serve GDR’s future trial.
In
view of our initiation of our PSC clinical program and our investment and collaboration with Onkai, we are no longer evaluating our strategic
alternatives.
Financial
Overview
To
date, we have funded our operations primarily through proceeds from private placements and public offerings. At March 31, 2023, we had
current assets of $12.8 million, which includes cash and cash equivalents of $1.7 million, short term deposit of $0.8 million, marketable
debt securities of $9.7 million, other receivables of $0.6 million and restricted cash of $0.1 million. This compares with current assets
of $14.7 million at December 31, 2022, which includes cash and cash equivalents of $2.0 million, marketable debt securities of $11.7
million, other receivables if $0.8 million and restricted cash of $0.1 million. Although we provide no assurance, we believe that such
existing funds will be sufficient to continue our business and operations as currently conducted for more than 12 months from the date
of issuance of this Form 6-K. However, we will continue to incur operating losses, which may be substantial over the next several years,
and we expect that we will need to obtain additional funds to further develop our research and development programs.
Costs
and Operating Expenses
Our
current costs and operating expenses consist of two components: (i) research and development expenses; and (ii) general and administrative
expenses.
Research
and Development Expenses
Our
research and development expenses consist primarily of outsourced development expenses, salaries and related personnel expenses and fees
paid to external service providers, patent and regulatory related legal fees, costs of pre-clinical studies and clinical trials and drug
and laboratory supplies. We account for all research and development expenses as they are incurred. We expect our research and development
expense to remain our primary expense in the near future as we continue to develop Aramchol and Amilo-5MER. Increases or decreases in
research and development expenditures are primarily attributable to the number and/or duration of the pre-clinical and clinical studies
that we conduct.
We
expect that a substantial amount of our research and development expense in the future will be incurred in support of our current and
anticipated pre-clinical and clinical development projects. Due to the inherently unpredictable nature of pre-clinical and clinical development
studies, we are unable to estimate with any certainty the costs we will incur in the continued development of Aramchol, Amilo-5MER and
any other potential product candidate. Clinical development timelines, the probability of success and development costs can differ materially
from expectations. We currently expect to continue testing Aramchol and Amilo-5MER in pre-clinical studies for toxicology, safety and
efficacy, and to conduct additional clinical trials for Aramchol and to initiate a first-in-human clinical study for Amilo-5MER.
While
we are currently focused on advancing Aramchol’s and Amilo-5MER’s development, our future research and development expenses
will depend largely on the clinical success of Aramchol, as well as ongoing assessments of the Aramchol’s commercial potential.
As we obtain results from clinical trials, we may elect to discontinue or delay clinical trials for our product candidate in certain
indications in order to focus our resources on more promising indications for such product candidate. Completion of clinical trials may
take several years or more, but the length of time generally varies according to the type, complexity, novelty and intended use of a
product candidate.
We
expect our research and development expenses to increase in the future from current levels as we continue to advance our clinical product
development into a pivotal stage trial and, potentially, the in-licensing of additional product candidates.
The
lengthy process of completing clinical trials and seeking regulatory approval for Aramchol requires the expenditure of substantial resources.
Any failure or delay in completing clinical trials, or in obtaining regulatory approvals, could cause a delay in generating product revenue
and cause our research and development expenses to increase and, in turn, have a material adverse effect on our operations. Because of
the factors set forth above, we are not able to estimate with any certainty when we would recognize any net cash inflows from our projects.
General
and Administrative Expenses
General
and administrative expenses consist primarily of compensation for employees in executive and operational roles, including finance, /accounting,
legal and other operating positions in connection with our activities. Our other significant general and administrative expenses include
non-cash stock-based compensation costs and facilities costs (including the rental expense for our offices in Tel Aviv, Israel), professional
fees for outside accounting and legal services, travel costs, investors relations, insurance premiums and depreciation.
Financial
expenses (income), Net
Our
financial income, net consists mainly of interest income from marketable debt securities, amortization of discount on safe notes and
foreign currency gains. Our financial expense consists of fees associated with banking activities and losses from realization of marketable
debt securities.
Results
of Operations
The
table below provides our results of operations for the three months ended March 31, 2023 as compared to the three months ended March
31, 2022.
| |
Three months ended March 31, | |
| |
2023 | | |
2022 | |
| |
(unaudited) | |
| |
(In thousands, except per share data) | |
Research and development expenses | |
| 1,083 | | |
| 4,796 | |
General and administrative expenses | |
| 919 | | |
| 1,296 | |
Total operating expenses | |
| 2,002 | | |
| 6,092 | |
Financial expense (income), net | |
| (172 | ) | |
| 51 | |
Net loss | |
| 1,830 | | |
| 6,143 | |
Other comprehensive loss: | |
| (100 | ) | |
| 445 | |
Comprehensive loss | |
| 1,730 | | |
| 6,588 | |
Basic and diluted net loss per share*) | |
$ | 1.09 | | |
$ | 3.67 | |
*) Retroactively adjusted to reflect the reverse split.
Research
and Development Expenses
Our
research and development expenses amounted to approximately $1.1 million during the three months ended March 31, 2023, representing a
decrease of approximately $3.7 million, or 77%, compared to approximately $4.8 million for the comparable period in 2022.The decrease
during the three months ended March 31, 2023 primarily resulted from a decrease in clinical trial expenses of approximately $2.2 million.
General
and Administrative Expenses
Our
general and administrative expenses amounted to approximately $0.9 million during the three months ended March 31, 2023, representing
a decrease of approximately $0.4 million, or 31%, compared to approximately $1.3 million for the comparable period in 2022. The decrease
in general and administrative expenses for the three months ended March 31, 2023 resulted primarily from a decrease in share based compensation
and professional services expenses.
Operating
Loss
As
a result of the foregoing, for the three months ended March 31, 2023, our operating loss was approximately $2.0 million, representing
a decrease of $4.1 million, or 67%, as compared to approximately $6.1 million for the comparable period in 2022.
Financial
expenses (income), Net
Our
financial income, net amounted to approximately $0.2 million during the three months ended March 31, 2023, compared to financial expenses
of $0.05 million for the comparable period in 2022.
The
financial income, net for the three months ended March 31, 2023 primarily relates to gain from amortization of discount on Safe notes.
Net
Loss
As
a result of the foregoing, for the three months ended March 31, 2023, our net loss was approximately $1.8 million, representing a decrease
of $4.3 million, or 70%, as compared to approximately $6.1 million for the comparable period in 2022.
Liquidity
and Capital Resources
To
date, we have funded our operations primarily through proceeds from private placements and public offerings and we have incurred substantial
losses since our inception. As of March 31, 2023, we had an accumulated deficit of approximately $187.9 million and positive working
capital (current assets less current liabilities) of approximately $10.0 million. We expect that operating losses will continue for the
foreseeable future.
As
of March 31, 2023, we had cash and cash equivalents of approximately $1.7 million, short term deposits of $0.8 million, restricted cash
of approximately $0.1 million and marketable debt securities of approximately $9.7 million invested in accordance with our investment
policy, totaling approximately $12.2 million, as compared to approximately $2.0 million, $0.1 million and $11.7 million as of December
31, 2022, respectively, totaling approximately $13.8 million. The decrease is mainly attributable to the $1.7 million negative cash flow
from operating activities during the three months ended March 31, 2023.
We
had negative cash flow from operating activities of approximately $1.7 million for the three months ended March 31, 2023, as compared
to negative cash flow from operating activities of approximately $5.5 million for the three months ended March 31, 2022. The negative
cash flow from operating activities for the three months ended March 31, 2023 is mainly attributable to our net loss of approximately
$1.8 million.
We
had positive cash flow from investing activities of approximately $1.3 million for the three months ended March 31, 2023, as compared
to a approximately $6.3 million for the three months ended March 31, 2022. The positive cash flow from investing activities for the three
months ended March 31, 2023 was primarily due to the net sale of available for sale securities, partially offset by investment in
short-term deposits.
We
had no cash flow from financing activities for the three months ended March 31, 2023 and March 31, 2022.
On
March 26, 2021, we entered into a Sales Agreement with Cantor Fitzgerald & Co. and Canaccord Genuity LLC, as sales agents, pursuant
to which we may offer and sell ordinary shares “at the market” having an aggregate offering price of up to $50.0 million
from time to time through the sales agents subject to the limits of General Instruction I.B.5 to Form F-3, also known as the baby shelf
rule. During July 2022, we sold 7,666 ordinary shares under our ATM program for total net proceeds of approximately $0.1 million.
Although
we provide no assurance, we believe that our existing funds will be sufficient to continue our business and operations as currently conducted
for more than 12 months from the date of issuance of this Report on Form 6-K. However, additional funding will be necessary to fund our
PSC program, the ARMOR Study (if re-iniitated), our Amilo-5MER program and ongoing research and development work, to advance our product
candidates through regulatory approval and into commercialization, if approved. We intend to obtain additional funding through debt or
equity financings, governmental grants or through entering into collaborations, strategic alliances or license agreements to increase
the funds available to support our operating and capital needs. Although we have been successful in raising capital in the past, there
is no assurance that we will be successful in obtaining additional financing on terms acceptable to us. Specifically, the COVID-19 pandemic
and the invasion of Ukraine has significantly disrupted global financial markets, and may limit our ability to access capital, which
could in the future negatively affect our liquidity. If funds are not available, we may be required to delay, reduce the scope of or
eliminate research or development plans for, or commercialization efforts with respect to Aramchol, Amilo-5MER and/or our other pre-clinical
and clinical programs. This may raise substantial doubts about our ability to continue as a going concern.
The
extent of our future capital requirements will depend on many other factors, including:
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the
progress and costs of our pre-clinical studies and other research and development activities; |
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the
regulatory pathway of Aramchol, Amilo-5MER or any other product candidate; |
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the
scope, prioritization and number of our research and development programs; |
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the
amount of revenues and contributions we receive under future licensing, development and commercialization arrangements with respect
to Aramchol or any other product candidtate; |
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the
costs of the development and expansion of our operational infrastructure; |
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the
costs and timing of obtaining regulatory approval for Aramchol, Amilo-5MER or any other product candidate; |
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the
ability of us, or our collaborators, to achieve development milestones, marketing approval and other events or developments under
our potential future licensing agreements; |
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the
costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights; |
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the
costs and timing of securing manufacturing arrangements for clinical or commercial production; |
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the
costs of contracting with third parties to provide sales and marketing capabilities for us; |
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the
costs of acquiring or undertaking development and commercialization efforts for any future products, product candidates or platforms; |
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the
magnitude of our general and administrative expenses; |
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any
cost that we may incur under future in- and out-licensing arrangements relating to Aramchol, Amilo-5MER or any other product candidate; |
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market
conditions; |
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our
ability to maintain the listing of our orindary share on The Nasdaq Capital Market; and |
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the
impact of the COVID-19 pandemic and the Russian invasion of Ukraine, which may exacerbate the magnitude of the factors discussed
above. |
Trend
Information
We
are a development stage company, and it is not possible for us to predict with any degree of accuracy the outcome of our research, development
or commercialization efforts. As such, it is not possible for us to predict with any degree of accuracy any significant trends, uncertainties,
demands, commitments or events that are reasonably likely to have a material effect on our net loss, liquidity or capital resources,
or that would cause financial information to not necessarily be indicative of future operating results or financial condition. However,
to the extent possible, certain trends, uncertainties, demands, commitments and events are in this “Management’s Discussion
and Analysis of Financial Condition and Results of Operations”.
Controls
and Procedures
As
a “foreign private issuer”, we are only required to conduct the evaluations required by Rules 13a-15(b) and 13a-15(d) of
the Exchange Act as of the end of each fiscal year and therefore have elected not to provide disclosure regarding such evaluations at
this time.
EXHIBIT
INDEX