- INT230-6, Intensity's lead drug candidate, continues to advance
into late-stage clinical programs in sarcoma and breast cancer
- Cash and investments of $10.5
million expected to fund operations through the end of the
first quarter of 2025
SHELTON,
Conn., May 9, 2024 /PRNewswire/ -- Intensity
Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a
late-stage clinical 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, announces first quarter 2024 financial
results and provides a corporate update.
Corporate Update
- In mid-2024, the Company intends on initiating a Phase 3
open-label, randomized study, or the INVINCIBLE-3 Study, testing
INT230-6 as a monotherapy compared to the standard of care ("SOC")
drugs in second and third line treatment for certain soft tissue
sarcoma subtypes. We plan to enroll 333 patients with an endpoint
of overall survival and have screened and qualified over 30 sites
for the INVINCIBLE-3 Study. Contract negotiations to approve and
activate these sites are in process. We estimate the sites could
take between two to six months to complete their contracting
processes.
- In mid-2024, the Company intends on initiating a Phase 2/3
program testing INT230-6 in combination with the SOC treatment
(chemotherapy/immunotherapy) compared to SOC alone in women with
triple negative breast cancer in presurgical (neoadjuvant) breast
cancer. The endpoint for the Phase 2 portion of the study, or the
INVINCIBLE-4 Study, is the change in the pathological complete
response rate for the combination compared to the SOC alone. We
expect to initiate the INVINCIBLE-4 Study in mid-2024, which will
provide data to size a Phase 3 study. We are in the process of
screening and qualifying sites for the INVINCIBLE-4 Study.
"We continue to make excellent progress towards the initiation
of our INVINCIBLE-3 Study," said Lewis H.
Bender, Founder, President and CEO of Intensity
Therapeutics, Inc. "In the first quarter, we were able to release
our INT230-6 Phase 3 clinical supplies, successfully ship the
entire batch to our main depot, and complete labeling of a portion
of the vials for the United States
sites. During the quarter, we completed evaluation of dozens
of sites and are now in various stages of contract and budget
discussions with over 30 different high-quality sarcoma centers. We
continue to qualify new sarcoma specialty hospitals in the US and
internationally, and top enrolling centers from our previous
metastatic study have expressed interest in participating in the
INVINCIBLE-3 trial." Mr. Bender continued, "Our INVINCIBLE-4 Study
also continues to make excellent progress. Sites are being
recruited and we continue to work towards initiating the study in
mid-2024."
First Quarter 2024 Financial Results
Research and development expenses were $2.8 million for the three months ended
March 31, 2024, compared to
$0.8 million for the same period in
2023. The increase was primarily due to preliminary work related to
the INVINCIBLE-3 Study, and to a lesser extent, costs for
manufacturing a new batch of INT230-6 and increased expenses
related to salary, benefits, and stock-based compensation.
General and administrative expenses were $1.9 million for the three months ended
March 31, 2024, compared to
$0.5 million for the same period in
2023. The increase was primarily due to increased expenses related
to salary, benefits and stock-based compensation, higher legal,
audit, and consulting fees, and higher directors and officers
insurance.
Overall, net loss was $4.6 million
for the three months ended March 31,
2024, compared to $1.3 million
for the three months ended March 31,
2023.
As of March 31, 2024, cash, cash
equivalents and marketable debt securities totaled $10.5 million, which the Company expects will be
sufficient to fund operations through the end of the first quarter
in 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
Intensity Therapeutics is a late-stage clinical 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 of INT230-6 to kill tumors and elicit an adaptive immune
response within days of injection, representing a novel approach to
cancer cell death that holds the potential to shift the treatment
paradigm and turn many deadly cancers into chronic diseases.
INT230-6 has completed enrollment of over 200 patients in a Phase
1/2 dose escalation trial (NCT03058289) and Phase 2 randomized
control clinical trial in breast cancer (the INVINCIBLE 2 study)
(NCT04781725). The Company is initiating a Phase 3 trial in
soft tissue sarcoma (the INVINCIBLE 3 study) (NCT06263231), testing
INT230-6 as second or third line monotherapy compared to the
standard of care with overall survival as an endpoint. The Company
is also planning a Phase 2/3 program in presurgical triple negative
breast cancer testing INT230-6 in combination with standard of care
compared to standard of care alone. 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 Company's expected future plans, cash
runway, development activities, projected milestones, business
activities or results. When or if used in this communication, the
words "may," "could," "should," "anticipate," "believe,"
"estimate," "expect," "intend," "plan," "predict" and similar
expressions and their variants, as they relate to the Company or
its management, may identify forward-looking statements. The
forward-looking statements contained in this press release are
based on management's 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. These risks and
uncertainties, many of which are beyond our control, include: the
initiation, timing, progress and results of future preclinical
studies and clinical trials and research and development programs;
the need to raise additional funding before the Company can expect
to generate any revenues from product sales; plans to develop and
commercialize product candidates; the timing or likelihood of
regulatory filings and approvals; the ability of the Company's
research to generate and advance additional product candidates; the
implementation of the Company's business model, strategic plans for
the Company's business, product candidates and technology;
commercialization, marketing and manufacturing capabilities and
strategy; the rate and degree of market acceptance and clinical
utility of the Company's system; the Company's competitive
position; the Company's intellectual property position;
developments and projections relating to the Company's competitors
and its industry; the Company's ability to maintain and establish
collaborations or obtain additional funding; expectations related
to the use of cash and cash equivalents and investments; estimates
regarding expenses, future revenue, capital requirements and needs
for additional financing; and 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:
Justin Kulik
justin@coreir.com
(558) 230-6401
Media Contact:
Jules
Abraham
CORE IR
julesa@coreir.com
Intensity
Therapeutics, Inc.
|
Condensed Statement
of Operations
|
(in thousands,
except share and per share amounts)
|
(Unaudited)
|
|
|
|
|
Three Months Ended
March 31,
|
|
2024
|
|
2023
|
Operating
expenses:
|
|
|
|
Research and
development
|
$
2,815
|
|
$
774
|
General and
administrative
|
1,928
|
|
480
|
Total operating
expenses
|
4,743
|
|
1,254
|
Loss from
operations
|
(4,743)
|
|
(1,254)
|
|
|
|
|
Other income
(expense):
|
|
|
|
Interest
income
|
140
|
|
—
|
Interest
expense
|
—
|
|
(83)
|
Other income
|
—
|
|
1
|
Net loss
|
$
(4,603)
|
|
$
(1,336)
|
|
|
|
|
Loss per share, basic
and diluted
|
$
(0.34)
|
|
$
(0.39)
|
Weighted average number
of shares of common stock, basic and diluted
|
13,709,487
|
|
3,410,103
|
Intensity
Therapeutics, Inc.
|
Condensed Balance
Sheets
|
(in
thousands)
|
(Unaudited)
|
|
|
March 31,
2024
|
|
December 31,
2023
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash, cash equivalents
and marketable debt securities
|
$
10,497
|
|
$
14,776
|
Prepaid expenses and
other current assets
|
672
|
|
688
|
Total current
assets
|
11,169
|
|
15,464
|
Right-of-use asset,
net
|
141
|
|
147
|
Other assets
|
1,098
|
|
1,684
|
Total
assets
|
$
12,408
|
|
$
17,295
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
1,219
|
|
$
3,048
|
Accrued
expenses
|
1,274
|
|
891
|
Lease liability,
current portion
|
26
|
|
20
|
Total current
liabilities
|
2,519
|
|
3,959
|
Other long-term
liabilities
|
36
|
|
36
|
Lease liability, net of
current portion
|
131
|
|
138
|
Total
liabilities
|
2,686
|
|
4,133
|
Total stockholders'
equity
|
9,722
|
|
13,162
|
Total liabilities and
stockholders' equity
|
$
12,408
|
|
$
17,295
|
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SOURCE Intensity Therapeutics Inc.