Closed Upsized IPO Priced at Top-Of-Range,
Full Exercise of the Over-Allotment Nets $20.4 Million in Proceeds
Data Presented at ASCO Showed that Lead Asset
INT230-6 Prolongs Survival Alone or in Combination With
Ipilimumab in Adult Patients with Relapsed, Refractory,
Metastatic Sarcomas Compared To Synthetic Controls
INVINCIBLE Study Data Presented at ASCO Showed
INT230-6 Following One Intratumoral Dose Can Cause Immune Priming
in Historically Quiescent Breast Cancers
WESTPORT, Conn., Aug. 14,
2023 /PRNewswire/ -- Intensity Therapeutics, Inc.
(Nasdaq: INTS), a clinical-stage biotechnology company focused on
the discovery and development of proprietary, novel immune-based
intratumoral cancer therapies designed to kill tumors and increase
immune system recognition of cancers, today reported financial
results for the second quarter ended June
30, 2023, and provided a corporate update.
"The second quarter of 2023 was transformative for Intensity
Therapeutics, during which, we closed an upsized initial public
offering (IPO), priced at top-of-the-range, despite a turbulent
biotech capital market environment. The $20.5 million of net proceeds now allows us to
further the development of our lead product candidate, INT230-6,
into registration studies," stated Lewis H.
Bender, President and Chief Executive Officer of Intensity
Therapeutics. "Notably, in June, our trial investigators presented
new data at the 2023 American Society of Clinical Oncology (ASCO)
Annual Meeting from the IT-01 phase 1/2 clinical study of INT230-6,
either as monotherapy or in combination with ipilimumab in patients
with relapsed, refractory and metastatic sarcomas, as well as from
the phase 2 INVINCIBLE study of INT230-6 in presurgical breast
cancer patients. The data demonstrated that, for all sarcoma
patients receiving at least one dose of INT230-6, alone, the median
overall survival was 21.3 months, compared to the typical 7 to 10
months in historical phase 1/2 studies. As a result of this
compelling data, interest in our novel approach was especially high
among the physicians who treat sarcoma, a deadly disease in
desperate need of new therapeutic approaches. We intend to submit
an Investigational New Drug (IND) application for a phase 3 study
of INT-230-6 in soft tissue sarcoma by the end of this year.
"Additionally, Angel Arnaout, M.D., Scientist and Surgical
Oncologist at the Ottawa Hospital, and Professor of Surgery at the
University of Ottawa was the lead
author on the poster reporting INVINCBLE results at ASCO on the use
of INT230-6 in early stage breast cancer. Results from Part 2 of
our INVINCIBLE study showed high levels of tumor necrosis,
expression levels of dendritic cells, macrophages and CD4 T-cells
tumor influx, post treatment using INT230-6, when comparing
patients treated with drug versus those in the control group. Dr.
Arnaout commented on how our new drug may shift the way all cancer
patients awaiting surgery are treated. Looking ahead, we expect to
report additional data from the INVINCIBLE study by year end and
are planning to launch a phase 2/3 program in a presurgical breast
cancer setting," concluded Mr. Bender.
Recent Company Highlights
- June 2023: Closed an upsized IPO
of 3.9 million shares of common stock at a public offering price of
$5.00 per share, representing the
top-of-the-range, raising net proceeds of $20.5 million after full 15% over-allotment.
- In June: Reported data at ASCO from 29 metastatic sarcoma
patients enrolled in the IT-01 study of lead product, INT230-6, a
locally delivered potent cytotoxic treatment; data showed extended
survival in refractory soft tissue sarcoma subjects by nearly 450
days compared to a synthetic control and that treatment with
INT230-6 induced an immune response in sarcoma tumors. Safety data
was favorable with the majority of adverse events being low
grade.
- In June: Presented data at ASCO meeting from the INVINCIBLE
study of INT230-6 in presurgical breast cancer, which reported that
gene enrichment pathway analysis demonstrated INT230-6 induced
signaling in the post-treatment samples, immune priming in
historically quiescent breast cancers and induced T-Cell receptor
signaling, macrophage markers, and IL-18 and B-Cell Receptor
signaling. Previously at ASCO and other oncology conferences, the
Company reported that INT230-6 resulted in major pathological
reduction in several early breast cancer patients with up to 100%
tumor necrosis after one intratumoral (IT) dose.
- Completed first drafts of the IT-01 clinical study reports for
INT230-6 alone, in combination with Merck's immunotherapy drug
pembrolizumab and in combination with Bristol-Myers Squibb's
immunotherapy drug, ipilimumab.
Anticipated 2023 Clinical Milestones
- Report additional results from IT-01 phase 1/2 clinical trial
of INT230-6 involving metastatic sarcomas.
- Report additional results from the phase 2 INVINCIBLE study in
presurgical breast cancer.
- File an Investigational New Drug (IND) application for a phase
3 study of INT230-6 in soft tissue sarcoma.
- Finalize the study design and a protocol for a phase 2/3
program in presurgical breast cancer.
Second Quarter 2023 Financial Highlights
Research and Development (R&D) Expenses were
$0.9 million for the three months
ended June 30, 2023 as compared to
$1.4 million for the same period last
year. The 38.0% decrease reflects the fact that Study IT-01 and
Study IT-02 no longer have patient care costs and the drafting of
results is nearly complete. Phase 3 IT-03 in sarcoma and phase 2/3
IT-04 in presurgical breast cancer will continue to incur planning,
multiple regulatory filing, manufacturing, study initiation and
trial preparation costs in 2023.
General and Administrative (G&A) Expenses were
$363,000 for the three months ended
June 30, 2023 as compared to
$545,000 for the same period in 2022.
The decrease is primarily due to the prior year having higher costs
relating to SEC filings and IPO expenses. The accounting services
and legal costs related to the IPO in 2023 were charged directly to
the equity section of the balance sheet as a reduction of
additional paid in capital.
Interest Expense for the three months ended
June 30, 2023 were $222,000 as compared to $15,000 for the three months ended June 30, 2022. The increase is due to the
execution of additional convertible notes in 2023.
Net Operating Loss for the second quarter ended
June 30, 2023 was $1.2 million as compared to $1.9 million for the three months ended
June 30, 2022.The current quarter
includes a non-operating loss of $2.3
million which is the discount from the IPO price that was
given to convertible debt holders as part of their agreements.
Cash and Cash Equivalents as of June 30, 2023, were approximately $136,000. After accounting for the total net cash
proceeds received following the closing of the IPO, of
approximately $20.5 million, the
Company expects to have sufficient cash to fund current operations
until early in the third quarter of 2025.
Conference Call and Webcast Information
The Company will hold a conference call today at 8AM EDT.
To participate in the conference call, please dial
1-877-317-6789 (domestic) or 1-412-317-6789 (international). To
access a live webcast of the call, please visit:
https://ir.intensitytherapeutics.com/news-events/events-presentations.
An archived replay of the webcast will be available for one year
on the Intensity Therapeutics website at:
https://ir.intensitytherapeutics.com/news-events/events-presentations.
About Intensity Therapeutics
Intensity Therapeutics,
Inc. is a clinical-stage biotechnology company pioneering a new
immune-based approach to treat solid tumor cancers. Intensity
leverages its DfuseRx℠ technology platform to create proprietary
drug formulations that following direct injection rapidly disperse
throughout a tumor and diffuse therapeutic agents into cancer
cells. Intensity's product candidates have the potential to induce
an adaptive immune response that not only attacks the injected
tumor, but also non-injected tumors. The Company's lead product
candidate, INT230-6, is in development for the treatment of
patients with solid tumors, such as sarcoma and breast cancer.
Intensity has a clinical collaboration agreement with Merck Sharpe
& Dohme (Merck) to evaluate INT230-6 with pembrolizumab. In
addition, the Company has a clinical collaboration agreement with
Bristol-Myers Squibb to evaluate the combination INT230-6 with
Bristol-Myers Squibb's anti-CTLA-4 antibody, ipilimumab. Intensity
has also executed agreements with the Ottawa Hospital Research
Institute (OHRI) and the Ontario Institute of Cancer Research
(OICR) to study INT230-6 in a randomized controlled neoadjuvant
phase 2 study in women with early stage breast cancer (the
INVINCIBLE study) (NCT04781725). Additionally, the Company executed
a Cooperative Research and Development Agreement (CRADA) with the
National Cancer Institute's (NCI) Vaccine Branch. For more
information, please visit www.intensitytherapeutics.com and follow
the Company on Twitter @IntensityInc.
Forward-Looking Statements
Certain statements in this
press release may constitute "forward-looking statements" within
the meaning of the United States Private Securities Litigation
Reform Act of 1995, as amended to date. These statements include,
but are not limited to, statements relating to the expected future
plans, development activities, projected milestones, business
activities or results. We have based these forward-looking
statements on our current expectations and projections about future
events, nevertheless, actual results or events could differ
materially from the plans, intentions and expectations disclosed
in, or implied by, the forward-looking statements we make. These
risks and uncertainties, many of which are beyond our control,
include: the risk that the anticipated milestones in 2023 or beyond
may be delayed or not occur or be changed, as well as other risks
described in the section entitled "Risk Factors" in the Company's
SEC filings, which can be obtained on the SEC website at
www.sec.gov. Readers are cautioned not to place undue reliance on
the forward-looking statements, which speak only as of the date on
which they are made and reflect management's current estimates,
projections, expectations and beliefs. The Company does not plan to
update any such forward-looking statements and expressly disclaims
any duty to update the information contained in this press release
except as required by law.
Contact Information
Investor Relations Contact:
Rx Communications
Group
Michael Miller
(917)-633-6086
mmiller@rxir.com
US Media Contact:
KOGS Communication
Edna Kaplan
+1 781 639 1910
kaplan@kogspr.com
Financials
Intensity
Therapeutics, Inc.
|
Condensed Statements
of Operations
|
(Unaudited)
|
|
|
|
Three Months
Ended
|
|
|
Six Months
Ended
|
|
|
|
June
30,
|
|
|
June
30,
|
|
|
|
2023
|
|
|
2022
|
|
|
2023
|
|
|
2022
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development costs
|
|
$
|
859,212
|
|
|
$
|
1,385,966
|
|
|
$
|
1,632,986
|
|
|
$
|
3,080,466
|
|
General and
administrative costs
|
|
|
362,490
|
|
|
|
543,830
|
|
|
|
842,846
|
|
|
|
1,227,853
|
|
Total operating
expenses
|
|
|
1,221,702
|
|
|
|
1,929,796
|
|
|
|
2,475,832
|
|
|
|
4,308,319
|
|
Loss from
operations
|
|
|
(1,221,702)
|
|
|
|
(1,929,796)
|
|
|
|
(2,475,832)
|
|
|
|
(4,308,319)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
171
|
|
|
|
213
|
|
|
|
487
|
|
|
|
856
|
|
Interest
expense
|
|
|
(221,779)
|
|
|
|
(14,959)
|
|
|
|
(305,161)
|
|
|
|
(29,754)
|
|
Loss on debt
extinguishment
|
|
|
(2,261,581)
|
|
|
|
-
|
|
|
|
(2,261,581)
|
|
|
|
-
|
|
Other
|
|
|
4,349
|
|
|
|
16,900
|
|
|
|
5,074
|
|
|
|
40,528
|
|
Net loss
|
|
$
|
(3,700,542)
|
|
|
$
|
(1,927,642)
|
|
|
$
|
(5,037,013)
|
|
|
$
|
(4,296,689)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock deemed
dividend
|
|
|
(1,323,535)
|
|
|
|
-
|
|
|
|
(1,323,535)
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable
to common stockholders
|
|
$
|
(5,024,077)
|
|
|
$
|
(1,927,642)
|
|
|
$
|
(6,360,548)
|
|
|
$
|
(4,296,689)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share, basic
and diluted
|
|
$
|
(1.43)
|
|
|
$
|
(0.57)
|
|
|
$
|
(1.84)
|
|
|
$
|
(1.26)
|
|
Weighted average number
of shares of common stock, basic and diluted.
|
|
|
3,516,579
|
|
|
|
3,410,103
|
|
|
|
3,463,635
|
|
|
|
3,410,103)
|
|
Intensity
Therapeutics, Inc.
|
Condensed Balance
Sheets
|
(Unaudited)
|
|
|
|
June 30,
2023
|
|
|
December 31,
2022
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
135,765
|
|
|
$
|
1,311,877
|
|
Stock subscriptions receivable
|
|
|
17,765,000
|
|
|
|
-
|
|
Other current assets
|
|
|
159,460
|
|
|
|
138,459
|
|
Total current
assets
|
|
|
18,060,225
|
|
|
|
1,450,336
|
|
Right-of-use asset,
net
|
|
|
-
|
|
|
|
139,089
|
|
Other assets
|
|
|
167,738
|
|
|
|
167,738
|
|
Total assets
|
|
$
|
18,227,963
|
|
|
$
|
1,757,163
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES,
REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY
(DEFICIENCY)
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
1,581,812
|
|
|
$
|
603,176
|
|
Accrued expenses
|
|
|
1,476,633
|
|
|
|
1,723,400
|
|
Current lease liability
|
|
|
-
|
|
|
|
143,221
|
|
Convertible note and accrued interest
|
|
|
-
|
|
|
|
4,348,548
|
|
Total current
liabilities
|
|
|
3,058,445
|
|
|
|
6,818,345
|
|
|
|
|
|
|
|
|
|
|
Related party deposit
|
|
|
36,000
|
|
|
|
36,000
|
|
Total
liabilities
|
|
|
3,094,445
|
|
|
|
6,854,345
|
|
Series A
redeemable convertible preferred stock, par value $.0001.
Authorized, issued, and outstanding shares of none and 5,000,000 as
of June 30, 2023 and December 31, 2022, respectively.
|
|
|
-
|
|
|
|
10,000,000
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS' EQUITY
(DEFICIENCY)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Authorized
preferred stock is 15,000,000 shares as of June 30, 2023. None
issued or outstanding as of June 30, 2023.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series B
convertible preferred stocks, par value $.0001. Authorized, issued,
and outstanding shares of none and 1,449,113 as of June
30, 2023 and December 31, 2022, respectively.
|
|
|
-
|
|
|
|
145
|
|
|
|
|
|
|
|
|
|
|
Series C
convertible preferred stocks, par value $.0001. Authorized, issued,
and outstanding shares of none and 1,800,606 as of June
30, 2023 and December 31, 2022, respectively.
|
|
|
-
|
|
|
|
180
|
|
|
|
|
|
|
|
|
|
|
Common
stock, par value $.0001. Authorized shares of 135,000,000 and
50,000,000 as of June 30, 2023 and December 31, 2022, respectively.
Issued and outstanding shares of 13,099,377 and 3,410,103 as of
June 30, 2023 and December 31, 2022, respectively.
|
|
|
1,310
|
|
|
|
341
|
|
Additional paid in
capital
|
|
|
60,145,764
|
|
|
|
23,555,160
|
|
Accumulated
deficit
|
|
|
(45,013,556)
|
|
|
|
(38,653,008)
|
|
Total stockholders' equity
(deficiency)
|
|
|
15,133,518
|
|
|
|
(15,097,182)
|
|
Total liabilities,
redeemable convertible preferred stock and stockholders' equity
(deficiency)
|
|
$
|
18,227,963
|
|
|
$
|
1,757,163
|
|
View original
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SOURCE Intensity Therapeutics, Inc.