SAN
JOSE, Calif., Jan. 21,
2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa"
or the "Company") (NASDAQ: ANIX), a biotechnology company focused
on the treatment and prevention of cancer, today provided the
following letter to shareholders from the Company's, Chairman and
CEO, Dr. Amit Kumar:
To our valued shareholders,
I am excited to highlight our key achievements from the past
year and share our upcoming goals and milestones for 2025 at Anixa
Biosciences. In 2024, we made remarkable progress in our mission to
develop innovative therapies and vaccines to combat cancer, all
while maintaining a strong financial foundation that positions us
to confidently pursue our ambitious goals.
We utilized only $7 million of
cash during the 2024 fiscal year, concluding with $20 million in cash and investments. Our prudent
financial management has ensured a strong balance sheet, giving us
the flexibility to advance our programs effectively.
At the Society for Immunotherapy of Cancer (SITC) conference on
November 8, 2024, we presented
positive preliminary Phase 1 data from our breast cancer vaccine
trial. The vaccine demonstrated promising results across three
patient groups:
- Recurrence Group: Survivors of triple-negative breast
cancer (TNBC) concerned about recurrence post-treatment.
- Prevention Group: Women with genetic mutations placing
them at high risk of developing breast cancer.
- Therapeutic Group: Women with residual disease following
standard-of-care treatment, where the vaccine was combined with
Keytruda (pembrolizumab).
We are encouraged by the positive data trends as additional
patients are enrolled in all three cohorts. The vaccine
demonstrated a strong safety profile, being well tolerated by
participants with protocol-defined immune responses observed in
over 70% of patients. Looking ahead, a Phase 2 study evaluating the
vaccine in the neoadjuvant setting is planned to commence in 2025,
marking an important next step in its development.
These early results provide a solid foundation for expanding our
vaccine programs. Building on the success of our breast cancer
vaccine, we began developing vaccines targeting prostate, lung, and
colon cancers, along with other major indications. The
collaboration with the National Cancer Institute on our ovarian
cancer vaccine also continues to progress. Meanwhile, we broadened
our patent portfolio across all development projects, strengthening
our intellectual property position.
Concurrently, our CAR-T program targeting ovarian cancer
advanced significantly. We completed treatment of the second dose
cohort and initiated treatment of the third dose cohort. A patient
from the first dose cohort showed a strong response, receiving FDA
authorization for a second dose of T cells. This patient remains
alive and well 21+ months after initial treatment. Other patients
in the trial have also shown encouraging results. These findings
offer promising signs that the CAR-T therapy may serve as a
successful long-term treatment option, highlighting its potential
effectiveness in the fight against ovarian cancer. Unlike
conventional CAR-T therapies, which excel in hematological cancers
but struggle with solid tumors, our platform shows promise in
overcoming this challenge. We believe it may effectively treat
ovarian cancer and other solid tumor types.
2025 holds significant promise as we aim to build on the
momentum of 2024:
- Breast Cancer Vaccine: Complete the Phase 1 trial,
present additional clinical data at scientific conferences, and
initiate the Phase 2 trial.
- CAR-T Clinical Trial: Complete treatment of the third,
fourth, and fifth dose cohorts and share data updates.
Additionally, we plan to initiate pre-clinical studies of our
CAR-T's effectiveness on other solid tumors.
- Vaccine Development: Continue development of vaccines
for ovarian, lung, prostate, and colon cancers, with progress
updates expected throughout the year.
With $20 million in cash and
investments, we have a cash runway of over 2.5 years. Our clean
capital structure—free of warrants, preferred stock, and
debt—positions us well to execute our plans and remain agile in a
dynamic environment.
We believe Anixa Biosciences is at the forefront of developing
transformative therapies for cancer, driven by science, innovation,
and a commitment to improving patient outcomes. Our strong
financial foundation and dedicated team ensure that we are
well-equipped to achieve our objectives and deliver value to our
shareholders.
Thank you for your continued support and belief in our mission.
Together, we are making significant strides in the fight against
cancer and paving the way for a healthier future.
Sincerely,
Dr. Amit Kumar
Chairman and CEO
Anixa Biosciences
About Anixa Biosciences, Inc.
Anixa is a
clinical-stage biotechnology company focused on the treatment and
prevention of cancer. Anixa's therapeutic portfolio consists of an
ovarian cancer immunotherapy program being developed in
collaboration with Moffitt Cancer Center, which uses a novel type
of CAR-T, known as chimeric endocrine receptor-T cell (CER-T)
technology. The Company's vaccine portfolio includes vaccines being
developed in collaboration with Cleveland Clinic to treat and
prevent breast cancer and ovarian cancer, as well as additional
cancer vaccines to address many intractable cancers, including high
incidence malignancies in lung, colon, and prostate. These vaccine
technologies focus on immunizing against "retired" proteins that
have been found to be expressed in certain forms of cancer. Anixa's
business model of partnering with world-renowned research
institutions on all stages of development allows the Company to
continually examine emerging technologies in complementary fields
for further development and commercialization. To learn more, visit
www.anixa.com or follow Anixa on Twitter, LinkedIn, Facebook
and YouTube.
Forward-Looking Statements
Statements that are not historical fact may be considered
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements are not statements of historical facts, but rather
reflect Anixa's current expectations concerning future events and
results. We generally use the words "believes," "expects,"
"intends," "plans," "anticipates," "likely," "will" and similar
expressions to identify forward-looking statements. Such
forward-looking statements, including those concerning our
expectations, involve risks, uncertainties and other factors, some
of which are beyond our control, which may cause our actual
results, performance or achievements, or industry results, to be
materially different from any future results, performance, or
achievements expressed or implied by such forward-looking
statements. These risks, uncertainties and factors include, but are
not limited to, those factors set forth in "Item 1A - Risk Factors"
and other sections of our most recent Annual Report on Form 10-K as
well as in our Quarterly Reports on Form 10-Q and Current Reports
on Form 8-K. We undertake no obligation to publicly update or
revise any forward-looking statements, whether as a result of new
information, future events or otherwise, except as required by law.
You are cautioned not to unduly rely on such forward-looking
statements when evaluating the information presented in this press
release.
Contact:
Mike Catelani
President, COO & CFO
mcatelani@anixa.com
408-708-9808
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SOURCE Anixa Biosciences, Inc.
