Presented positive Phase 1/2 clinical data for
INT230-6 in patients with refractory soft tissue sarcoma at
Connective Tissue Oncology Society ("CTOS"), demonstrating 93%
disease control rate in patients on monotherapy and survival
extension of nearly 15 months vs. synthetic control group
Received Orphan Drug Designation for the three
components of INT230-6 for the treatment of soft tissue
sarcoma
Closed upsized IPO and full exercise of
over-allotment option for $20.2
million in net proceeds
On track to file IND for Phase 3 study of
INT230-6 in soft tissue sarcoma and to report additional Phase 2
INVICIBLE study results for presurgical breast cancer by end of
2023
SHELTON,
Conn., Nov. 13, 2023 /PRNewswire/
-- Intensity Therapeutics, Inc. (Nasdaq: INTS), a late-stage
biotechnology company that applies novel engineered chemistry to
discover and develop proprietary, novel immune-based intratumoral
cancer therapies designed to kill tumors and increase immune system
recognition of cancers, today reported financial results for the
third quarter ended September 30,
2023, and provided a corporate update.
"Metastatic soft tissue sarcoma continues to plague cancer
patients who have poor survival outcomes and insufficient
therapeutic options. The positive overall survival and disease
control rate data from our Phase 1/2 clinical trial of INT230-6
positions our lead candidate as a potential much needed reprieve,
keeping the drug inside the tumor while sparing the body of
toxicity. We expect to file an IND for a Phase 3 study of INT230-6
in soft tissue sarcoma by the end of 2023 and look forward to
progressing this study," said Lewis H.
Bender, President and Chief Executive Officer of
Intensity.
Mr. Bender added: "To continue the momentum built from our
successful upsized IPO in July, we also look forward to reporting
additional results from our Phase 2 INVINCIBLE study in presurgical
breast cancer at a medical meeting and finalizing the study design
and protocol for a Phase 2/3 program in presurgical breast cancer
before year end. I am pleased with our pace of progress to advance
the clinical development of INT230-6 and am strongly encouraged by
data to date, which reinforces the potential of INT230-6 to shift
the treatment paradigm of cancer."
Recent Company Highlights
- Presented Positive INT230-6 Data in Patients with Refractory
Soft Tissue Sarcoma at the Connective Tissue Oncology Society
(CTOS). In November, the Company presented positive data from
its ongoing Phase 1/2 clinical trial of INT230-6 at the CTOS annual
meeting. The data presented demonstrated a strong disease control
rate of 93% for subjects in the monotherapy arm while also
extending survival in subjects by nearly 15 months when compared to
a synthetic control group. INT230-6 was found to be generally safe
and well tolerated with the majority of treatment-emergent adverse
events being grade 1 or 2.
- Received Orphan Drug Designation for Components of
INT230-6 for the Treatment of Soft Tissue Sarcoma. In
September, Intensity was granted orphan drug designation (ODD) by
the US Food and Drug Administration for three active moieties
comprising its lead candidate INT230-6: cisplatin, vinblastine
sulfate, and the diffusion enhancer SHAO-FA (8-((2-hydroxybenzoyl)
amino)octanoate).
- Completed Upsized Initial Public Offering (IPO) with Full
Exercise of the Over-Allotment Option. In July, Intensity
announced that it had closed its IPO with the full exercise of its
over-allotment option. Intensity received a total of $20.2 million in net proceeds from the
transaction, providing sufficient cash and cash equivalents to fund
operations into the second half of 2025.
Anticipated Near-Term Milestones
- Report additional results from the Phase 2 INVINCIBLE study in
presurgical breast cancer at a medical meeting in 4Q 2023
- File an Investigational New Drug (IND) application for a Phase
3 study of INT230-6 in soft tissue sarcoma in 4Q 2023
- Finalize the study design for a Phase 2/3 program in
presurgical breast cancer in 4Q 2023
Third Quarter 2023 Financial Highlights
Research and Development (R&D) Expenses were
$1.4 million for the three months
ended September 30, 2023, as compared
to $1.2 million for the same period
last year. The increase is due to ongoing Phase 3 IT-03 in sarcoma
and phase 2/3 IT-04 in presurgical breast cancer, which will
continue to incur planning, multiple regulatory filing,
manufacturing, study initiation and trial preparation costs in
2023.
General and Administrative (G&A) Expenses were
$1.1 million for the three months
ended September 30, 2023, as compared
to $0.6 million for the same period
in 2022. The increase is primarily due to the costs of operating as
a public company. 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 September 30, 2023, were $0 as compared to $15,123 for the three months ended September 30, 2022. The decrease is due to the
convertible notes and accrued interest being converted to common
stock at the time of the IPO.
Net Operating Loss for the third quarter ended
September 30, 2023, was $2.3 million as compared to $1.8 million for the three months ended
September 30, 2022.
Cash, Cash Equivalents and Marketable Securities as of
September 30, 2023, were
approximately $15.6 million. The
Company expects to have sufficient cash to fund current operations
into the second half of 2025.
About INT230-6
INT230-6, Intensity's lead proprietary
investigational product candidate, is designed for direct
intratumoral injection. INT230-6 was discovered using Intensity's
proprietary DfuseRx℠ technology platform. The drug is composed of
two proven, potent anti-cancer agents, cisplatin and vinblastine,
and a penetration enhancer molecule (SHAO) that helps disperse
potent cytotoxic drugs throughout tumors for diffusion into cancer
cells. These agents remain in the tumor resulting in a favorable
safety profile. In addition to local disease control, direct
killing of the tumor by INT230-6 releases a bolus of neoantigens
specific to the patient's malignancy, leading to engagement of the
immune system and systemic anti-tumor effects. Importantly, these
effects are mediated without immunosuppression that so often occurs
with systemic chemotherapy.
About Intensity Therapeutics' Clinical
Studies
INT230-6 has completed enrollment of over 200
patients in two phase 2 and phase 1 dose escalation clinical trials
(NCT03058289 and NCT04781725) with various advanced solid tumors;
IT-01 in metastatic disease, and IT-02 the INVINCIBLE study, in
presurgical breast cancer. The Company has a clinical collaboration
agreement with Merck Sharpe & Dohme (Merck) to evaluate the
combination of INT230-6, Intensity's lead product candidate, and
KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 (programmed death
receptor-1) therapy, in patients with advanced pancreatic, colon,
squamous cell and bile duct malignancies. The Company also 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, in patients with advanced liver,
breast and sarcoma cancers. Intensity managed the individual
combination arms separately with each respective partner via a
joint development committee. The Company also executed agreements
with the Ottawa Hospital Research Institute (OHRI) and the Ontario
Institute of Cancer Research (OICR) to study INT230-6 in the
INVINCIBLE study, a randomized controlled neoadjuvant phase 2 study
in women with early-stage breast cancer. Near-term, Intensity
expects to file an Investigational New Drug (IND) application for a
Phase 3 study of INT230-6 in soft tissue sarcoma as well as
finalizing the study design and protocol for a Phase 2/3 program in
presurgical breast cancer.
About Intensity Therapeutics
Intensity Therapeutics is
a late-stage biotechnology company that applies novel engineered
chemistry to turn "cold" tumors "hot" by enabling its aqueous
cytotoxic-containing drug product, INT230-6, to mix and saturate
the dense, high-fat pressurized environment of the tumor. As a
result of the saturation, Intensity's clinical trials have
demonstrated the ability if INT230-6 to kill tumors and elicit an
adaptive immune response within days of injection, representing a
truly novel approach to cancer cell death that holds the potential
to shift the treatment paradigm and turn many deadly cancers into
chronic diseases. For more information about the Company, including
publications, papers and posters about its novel approach to cancer
therapeutics, visit www.intensitytherapeutics.com.
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 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.
Investor Relations Contact:
Argot Partners
Jonathan Nugent
Intensity@argotpartners.com
Media Contact:
Argot Partners
David Rosen
david.rosen@argotpartners.com
Intensity
Therapeutics, Inc.
|
Condensed Statement
of Operations
|
(Unaudited)
|
|
|
|
Three Months
Ended
|
|
|
Nine Months
Ended
|
|
|
|
September
30,
|
|
|
September
30,
|
|
|
|
2023
|
|
|
2022
|
|
|
2023
|
|
|
2022
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development costs
|
|
$
|
1,351,766
|
|
|
$
|
1,160,737
|
|
|
$
|
2,984,752
|
|
|
$
|
4,241,203
|
|
General and
administrative costs
|
|
|
1,138,748
|
|
|
|
607,113
|
|
|
|
1,981,594
|
|
|
|
1,834,966
|
|
Total operating
expenses
|
|
|
2,490,514
|
|
|
|
1,767,850
|
|
|
|
4,966,346
|
|
|
|
6,076,169
|
|
Loss from
operations
|
|
|
(2,490,514)
|
|
|
|
(1,767,850)
|
|
|
|
(4,966,346)
|
|
|
|
(6,076,169)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
147,539
|
|
|
|
988
|
|
|
|
148,026
|
|
|
|
1,844
|
|
Interest
expense
|
|
|
-
|
|
|
|
(15,123)
|
|
|
|
(305,161)
|
|
|
|
(44,877)
|
|
Loss on debt
extinguishment
|
|
|
-
|
|
|
|
-
|
|
|
|
(2,261,581)
|
|
|
|
-
|
|
Other
|
|
|
13,230
|
|
|
|
7,118
|
|
|
|
18,304
|
|
|
|
47,646
|
|
Net loss
|
|
$
|
(2,329,745)
|
|
|
$
|
(1,774,867)
|
|
|
$
|
(7,366,758)
|
|
|
$
|
(6,071,556)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock deemed
dividend
|
|
|
-
|
|
|
|
-
|
|
|
|
(1,323,535)
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable
to common stockholders
|
|
$
|
(2,329,745)
|
|
|
$
|
(1,774,867)
|
|
|
$
|
(8,690,293)
|
|
|
$
|
(6,071,556)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share, basic
and diluted
|
|
$
|
(0.17)
|
|
|
$
|
(0.52)
|
|
|
$
|
(1.26)
|
|
|
$
|
(1.78)
|
|
Weighted average number
of shares of common stock, basic and diluted.
|
|
|
13,660,627
|
|
|
|
3,410,103
|
|
|
|
6,899,984
|
|
|
|
3,410,103
|
|
Intensity
Therapeutics, Inc.
|
Condensed Balance
Sheets
|
(Unaudited)
|
|
|
|
September 30,
2023
|
|
|
December 31,
2022
|
|
|
|
(unaudited)
|
|
|
(audited)
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
6,693,825
|
|
|
$
|
1,311,877
|
|
Marketable debt securities
|
|
|
8,955,316
|
|
|
|
-
|
|
Prepaid expenses
|
|
|
971,239
|
|
|
|
62,924
|
|
Other current assets
|
|
|
14,366
|
|
|
|
75,535
|
|
Total current
assets
|
|
|
16,634,746
|
|
|
|
1,450,336
|
|
Right-of-use asset,
net
|
|
|
152,605
|
|
|
|
139,089
|
|
Other assets
|
|
|
28,438
|
|
|
|
167,738
|
|
Total assets
|
|
$
|
16,815,789
|
|
|
$
|
1,757,163
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES,
REDEEMABLE CONVERTIBLE PREFERRED STOCK AND
STOCKHOLDERS' EQUITY (DEFICIENCY)
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
358,404
|
|
|
$
|
603,176
|
|
Accrued expenses
|
|
|
355,006
|
|
|
|
1,723,400
|
|
Current lease liability
|
|
|
10,556
|
|
|
|
143,221
|
|
Convertible note and accrued interest
|
|
|
-
|
|
|
|
4,348,548
|
|
Total current
liabilities
|
|
|
723,966
|
|
|
|
6,818,345
|
|
Long-term lease
liability
|
|
|
144,891
|
|
|
|
-
|
|
Related party deposit
|
|
|
36,000
|
|
|
|
36,000
|
|
Total
liabilities
|
|
|
904,857
|
|
|
|
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 September 30, 2023 and
December 31, 2022,
respectively.
|
|
|
-
|
|
|
|
10,000,000
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS' EQUITY
(DEFICIENCY)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Authorized
preferred stock is 15,000,000 shares as
of September 30, 2023. None issued or
outstanding as of September 30, 2023.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series B
convertible preferred stock, par value $.0001. Authorized, issued,
and
outstanding shares of none and
1,449,113 as of September 30, 2023 and December 31,
2022, respectively.
|
|
|
-
|
|
|
|
145
|
|
|
|
|
|
|
|
|
|
|
Series C
convertible preferred stock, par value $.0001. Authorized,
issued,
and
outstanding shares of none and 1,800,606 as of September
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 September 30, 2023 and
December 31, 2022, respectively. Issued and outstanding
shares of 13,709,377 and
3,410,103 as of September 30, 2023 and December 31, 2022,
respectively.
|
|
|
1,371
|
|
|
|
341
|
|
Additional paid-in
capital
|
|
|
63,252,862
|
|
|
|
23,555,160
|
|
Accumulated
deficit
|
|
|
(47,343,301)
|
|
|
|
(38,653,008)
|
|
Total stockholders'
equity (deficiency)
|
|
|
15,910,932
|
|
|
|
(15,097,182)
|
|
Total liabilities,
redeemable convertible preferred stock and stockholders' equity
(deficiency)
|
|
$
|
16,815,789
|
|
|
$
|
1,757,163
|
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/intensity-therapeutics-reports-third-quarter-financial-results-and-provides-corporate-update-301985474.html
SOURCE Intensity Therapeutics Inc.