IMUNON CEO RECAPS A YEAR OF CLINICAL ACHIEVEMENT AND SOLID FUNDAMENTALS
June 02 2025 - 8:05AM
IMUNON, Inc. (NASDAQ: IMNN)
Dear Valued Shareholders,
A Year of Breakthroughs: IMUNON Has
Never Been Stronger
As I mark my first year as President and CEO of
IMUNON, I am thrilled to share the progress we have made in
advancing our mission to transform cancer treatment. With robust
fundamentals and groundbreaking clinical data, your company is well
positioned to deliver an innovative therapy and to create
significant value for you, our shareholders.
Progress with IMNN-001: A Potential
Game-Changer for Ovarian Cancer
Over the past year, we have achieved remarkable
milestones, most notably with our lead candidate, IMNN-001, which
has entered the pivotal Phase 3 OVATION 3 Study for the frontline
treatment of women newly diagnosed with advanced ovarian cancer.
The Phase 2 OVATION 2 Study (n=112, median follow-up of 31 months)
has demonstrated powerful and highly encouraging results,
positioning IMNN-001 as a potential advance in the standard of
care. Key findings, that will be presented tomorrow, June 3, in an
oral presentation at the prestigious American Society of Clinical
Oncology (ASCO) Annual Meeting and are also being published
simultaneously in Gynecologic Oncology, include:
- Significant Survival Benefits: In
the intent-to-treat (ITT) population, IMNN-001 plus
standard-of-care neoadjuvant and adjuvant chemotherapy (N/ACT)
extended median overall survival (OS) by 13 months (46 vs. 33
months) compared to standard-of-care N/ACT alone, with a hazard
ratio of 0.69. As Dr. Premal H. Thaker, OVATION 2 Study Chair and
Interim Chief of Gynecologic Oncology at Washington University
School of Medicine, noted, “An increase in survival of six months
is considered clinically meaningful. The data indicating that
IMNN-001 could extend lives by one year or longer represent a
potentially historic advance.”
- Enhanced Efficacy with PARP
Inhibitors: For patients receiving poly ADP-ribose polymerase
(PARP) inhibitors as maintenance therapy, median OS in the IMNN-001
arm has not yet been reached after more than five years (vs. 37
months in the control arm), with a hazard ratio of 0.38.
- Strong Results in HRD+ and BRCA
Populations: Increased therapeutic activity was observed in women
with homologous recombination deficiency (HRD+), including BRCA1/2
mutations, with a hazard ratio of 0.42.
- Consistency of Clinical Data:
Consistency, across multiple endpoints, subgroups and data
analyses, suggest that the OS results are real and have great
promise to be confirmed in our Phase 3 study, and particularly in
the HRD+ and BRCA-mutated population where this important subgroup
readout may occur much sooner than in the ITT population.
- Favorable Safety Profile: IMNN-001
was well tolerated, with primarily manageable adverse events (e.g.,
abdominal pain, nausea, vomiting) and no reports of cytokine
release syndrome, systemic toxicity, or serious immune-related
adverse events, making it a promising first-in-class
immunotherapy.
- Our dialogue with the U.S. Food and
Drug Administration (FDA), to date, has not identified any
fundamental weaknesses in our data, analyses or assumptions. Their
alignment in support of our Phase 3 trial was quick and
unambiguous.
With these results, IMNN-001 becomes the first
immunotherapy with a favorable safety profile to demonstrate
survival benefits in a frontline setting leading to the potential
to transform ovarian cancer treatment.
TheraPlas Platform: A Foundation for Broad
Impact
The TheraPlas platform, which powers IMNN-001,
leverages the immunological properties of interleukin-12 (IL-12) to
target the tumor microenvironment effectively. These data further
validate TheraPlas’ potential to treat ovarian cancer while
alleviating side effects often seen with other immunotherapies.
Beyond ovarian cancer, we are exploring IMNN-001 applications in
other tumor types and TheraPlas’ ability to carry other therapeutic
DNA payloads, both of which could unlock significant opportunities
for growth and partnerships.
Growing Momentum and Financial
Discipline
Our clinical success has attracted increasing
interest from institutional investors, reflecting confidence in our
science and strategy. The recent upward trajectory in our share
price positions us well to potentially meet the $1 NASDAQ listing
requirement in the near term. As we prepare for the Phase 3 OVATION
3 Study, which will evaluate IMNN-001 in women with stage IIIC or
IV ovarian cancer (randomized 1:1, with OS as the primary
endpoint), we are committed to funding this pivotal trial
strategically. We have taken steps to conserve cash and align our
critical needs with available capital on hand, while securing the
resources needed to advance this potentially transformative therapy
through optimal opportunities.
Looking Ahead: A Bright Future for
IMUNON
With a pivotal Phase 3 trial on the horizon,
compelling data validating our TheraPlas platform, and a clear
financial strategy, IMUNON is poised for transformative growth. We
are dedicated to bringing IMNN-001 to patients in desperate need of
new treatment options while delivering sustainable value to you,
our shareholders.
On behalf of the entire IMUNON team, thank you
for your continued support and belief in our vision. Together, we
are building a company that has the potential to redefine cancer
care. I look forward to sharing more milestones as we advance
toward our goal.
Sincerely,Stacy R. Lindborg, Ph.D.President and Chief Executive
OfficerIMUNON, Inc.
Forward-Looking Statements
IMUNON wishes to inform readers that
forward-looking statements in this letter are made pursuant to the
“safe harbor” provisions of the Private Securities Litigation
Reform Act of 1995. All statements, other than statements of
historical fact, including, but not limited to, statements
regarding the timing and enrollment of the Company’s clinical
trials, the potential of any therapies developed by the Company to
fulfill unmet medical needs, the market potential for the Company’s
products, if approved, the potential efficacy and safety profile of
our product candidates, and the Company’s plans and expectations
with respect to its development programs more generally, are
forward-looking statements. We generally identify forward-looking
statements by using words such as “may,” “will,” “expect,” “plan,”
“anticipate,” “estimate,” “intend” and similar expressions (as well
as other words or expressions referencing future events, conditions
or circumstances). Readers are cautioned that such forward-looking
statements involve risks and uncertainties including, without
limitation, uncertainties relating to unforeseen changes in the
course of research and development activities and in clinical
trials, including the fact that interim results are not necessarily
indicative of final results; the uncertainties of and difficulties
in analyzing interim clinical data; the significant expense, time
and risk of failure in conducting clinical trials; the need for
IMUNON to evaluate its future development plans; possible actions
by customers, suppliers, competitors or regulatory authorities; and
other risks detailed from time to time in IMUNON’s filings with the
Securities and Exchange Commission. IMUNON assumes no obligation,
except to the extent required by law, to update or supplement
forward-looking statements that become untrue because of subsequent
events, new information or otherwise.
Contacts:
Media |
Investors |
|
|
Jenna Urban |
Peter Vozzo |
CG life |
ICR Healthcare |
212-253-8881 |
443-213-0505 |
jurban@cglife.com |
peter.vozzo@icrhealthcare.com |
Imunon (NASDAQ:IMNN)
Historical Stock Chart
From Jun 2025 to Jul 2025
Imunon (NASDAQ:IMNN)
Historical Stock Chart
From Jul 2024 to Jul 2025