Equity Insider News Commentary
Issued on behalf of Oncolytics Biotech
Inc.
VANCOUVER, BC, April 14,
2025 /PRNewswire/ -- Equity Insider News
Commentary – Routine medical appointments or cancer
screenings—critical for catching the disease in earlier, more
treatable stages—has dropped to just over 50% of the population. At
the same time, doctors are raising alarm bells over a noticeable
increase in cancer diagnoses among younger adults, especially
women. With proposed funding cuts to the NIH now on the
table and new estimates suggesting that drug tariffs could add
$10,000 or more to treatment costs,
the path forward may rely less on government programs and more on
private-sector breakthroughs. So far in 2025, several oncology
innovators have stepped forward with meaningful updates, including
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC),
CEL-SCI Corporation (NYSE-American: CVM), OS Therapies
Incorporated (NYSE-American: OSTX), BeiGene, Ltd.
(NASDAQ: ONC), and Actinium Pharmaceuticals, Inc.
(NYSE-American: ATNM).
Forecasts show cancer's global footprint expanding sharply, with
annual case counts expected to rise 20% by 2030 and swell by 75% by
mid-century, according to Statista. Meanwhile, Precedence
Research projects the global immunotherapy drugs market will
reach nearly US$1.2 trillion by 2033,
driven by an 18% compound annual growth rate.
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC)
recently turned heads after securing a new share purchase agreement
with Alumni Capital that could provide up to US$20 million in flexible financing, and
potentially increase available capital by nearly 45% of the
company's valuation at the time of the announcement. The deal gives
Oncolytics the right—but not the obligation—to raise capital
over a 15-month period through equity sales under its own
control.
For a clinical-stage company heading toward multiple inflection
points, the agreement offers an important advantage: access to cash
if and when it's strategically needed. The announcement was met
with heightened market interest, driving a notable spike in share
price and trading volume on Friday, as investors reacted to the
added financial runway and the timing of upcoming trial
updates.
The capital agreement reinforces a broader narrative taking
shape in 2025. Oncolytics continues to advance pelareorep,
its intravenously delivered immunotherapy, which triggers a
systemic immune response against tumors.
Pelareorep is being tested across multiple solid tumor types
where outcomes remain poor, including HR-positive HER2-negative
metastatic breast cancer, pancreatic ductal adenocarcinoma (PDAC),
and advanced anal cancer. All three indications are now being
studied in multi-drug combination trials that reflect real-world
treatment settings and physician preferences.
"With multiple clinical trials surpassing expectations in 2024,
2025 is shaping up to be a defining year for Oncolytics,"
said Wayne Pisano, Chair of Oncolytics' Board of
Directors and Interim CEO in a recent update. "Our top priority is
HR+/HER2- metastatic breast cancer, in which two randomized trials
involving over 100 patients have shown substantial clinical benefit
for patients receiving pelareorep and paclitaxel compared to
paclitaxel monotherapy. We believe that if we can approximate the
benefit we saw in BRACELET-1 in our planned registrational study,
the progression-free survival benefit alone would support an
accelerated approval submission."
In breast cancer, the company recently completed a randomized
Phase 2 trial called BRACELET-1. In this study, patients treated
with pelareorep and paclitaxel outperformed those receiving
paclitaxel alone, showing a near doubling in progression-free
survival. The company has stated that the data support moving ahead
with a larger registrational study, expected to begin later this
year. If new results mirror those seen in BRACELET-1,
Oncolytics may have the foundation to submit for accelerated
approval in this indication.
Meanwhile, the company continues to expand its gastrointestinal
cancer program. A pancreatic cancer cohort within the GOBLET study
is moving toward full enrollment, after clearing safety hurdles
with regulators in Germany.
Patients will receive pelareorep alongside a modified FOLFIRINOX
chemotherapy regimen—with or without the checkpoint inhibitor
atezolizumab. Interim efficacy results from this arm are expected
later in 2025 and may inform the structure of a future
registration-enabling trial. Notably, Oncolytics is working
with the Pancreatic Cancer Action Network (PanCAN) on this
cohort, as they provided a US$5
million grant to fund it.
In advanced anal cancer, pelareorep is being tested with
atezolizumab in another GOBLET cohort. Among the first 12 patients,
four showed partial responses and one had a complete response
lasting over 15 months. Based on these early outcomes—stronger than
what's typically seen from checkpoint inhibitors alone—the company
has expanded the cohort to include an additional 18 patients.
Pelareorep's unique mechanism of action has garnered attention
from key opinion leaders in immunotherapy. During a recent event
hosted by H.C. Wainwright, Profs. Martine Piccart and
Alexander Eggermont emphasized
pelareorep's ability to turn so-called "cold" tumors "hot,"
potentially enhancing the effectiveness of checkpoint inhibitors
and other cancer therapies in difficult-to-treat cancers like PDAC
and HR+/HER2- metastatic breast cancer.
As of the end of Q4 2024, Oncolytics reported
$15.9 million in cash on hand, with
operations funded into the third quarter of 2025. With late-stage
trials being planned, multiple data readouts on the horizon, and a
flexible US$20 million equity
facility now in place, the company enters Q2 not just with
momentum—but with the financial agility to match it.
CONTINUED… Read this and more news for Oncolytics Biotech
at:
https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
In other recent industry developments and happenings in the
market include:
CEL-SCI Corporation (NYSE-American: CVM) is gaining
traction after a study published in Cancer Cell validated
its approach to seeking early approval for Multikine, its lead
immunotherapy candidate for head and neck cancer.
"The data from both our completed Multikine neoadjuvant Phase 3
study and the study published in Cancer Cell show
that newly diagnosed locally advanced head and neck cancer patients
who were treated with immune therapies before surgery and had tumor
responses, were also likely to have better overall survival," said
Geert Kersten, CEO of
CEL-SCI. "This is quite logical—when a person's tumor
shrinks in response to immunotherapy treatment before the tumor is
removed by surgery—their survival outcome is expected to be
better."
Patients who responded to Multikine before surgery had
significantly higher survival rates than those who didn't respond.
The FDA has approved a 212-patient confirmatory trial to
support the company's regulatory path forward.
"We believe that the recent greater availability of
peer-reviewed published data specific to neoadjuvant therapy and
early tumor response in head and neck cancer supports our
development and regulatory efforts," added Kersten.
OS Therapies Incorporated (NYSE-American: OSTX), has
completed its acquisition of Advaxis Immunotherapies'
listeria-based cancer programs, securing full IP ownership and
strengthening its leadership in this emerging therapeutic
category.
"We are thrilled to have now consolidated all of the
intellectual property for the listeria cancer immunotherapy
platform into OS Therapies, positioning us to fully expand
it in the years ahead and improve the standard of care across
cancer treatment in the years ahead," said Paul Romness, CEO of OS Therapies. "We
now have late-stage, mid-stage and early-stage cancer immunotherapy
candidates, a rich pipeline of preclinical cancer immunotherapy
candidates and a long IP runway to in order to fully leverage this
powerful cancer immunotherapy platform."
The company's pipeline now includes three clinical-stage
immunotherapies and eight additional preclinical assets aimed at
more than 30 cancer types. Its lead candidate, OST-HER2, is
expected to be submitted for FDA accelerated approval by
year-end for recurrent, lung-metastatic osteosarcoma. If approved,
the company would become eligible for a Priority Review Voucher,
currently valued at $150 million.
BeiGene, Ltd. (NASDAQ: ONC) recently received a positive
opinion from the European Medicines Agency's CHMP for
TEVIMBRA (tislelizumab) in combination with chemotherapy as a
first-line treatment for extensive-stage small cell lung cancer,
based on a Phase 3 study showing a significant overall survival
benefit. Weeks earlier, the FDA approved TEVIMBRA with chemo
for first-line treatment of PD-L1-positive esophageal squamous cell
carcinoma after another Phase 3 trial showed a 34% reduction in the
risk of death.
"Today's positive CHMP opinion marks another important step for
TEVIMBRA to potentially expand its indications in a fourth disease
area in Europe to reach more
patients affected by cancer," said Mark
Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at
BeiGene. "TEVIMBRA is the cornerstone of our solid tumor
portfolio with 58 regulatory approvals in 18 months and is being
studied in combination with multiple novel molecules with the
potential to herald the next wave of cancer therapeutics."
TEVIMBRA is now approved in over 45 countries and remains the
backbone of BeiGene's expanding solid tumor portfolio.
Actinium Pharmaceuticals, Inc. (NYSE-American: ATNM)
recently unveiled ATNM-400, a first-in-class, non-PSMA targeting
prostate cancer radiotherapy powered by the potent alpha-emitter
Actinium-225, showing 99.8% tumor inhibition in preclinical models.
The company plans to present these data at AACR 2025, targeting a
major unmet need in patients who progress after Pluvicto.
"The current era of radiotherapy is built on the clinical and
commercial success of Pluvicto in prostate cancer," said
Sandesh Seth, Chairman and CEO of
Actinium. "The field is now looking to address patients that
do not respond or progress after Pluvicto therapy. We believe
ATNM-400 can address this high unmet need and we are incredibly
excited by our data to date."
Alongside ATNM-400, Actinium is advancing clinical
programs across AML, solid tumors, and cell therapy
conditioning—backed by a robust patent portfolio and expanding
in-house manufacturing infrastructure.
Source:
https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
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