PDS Biotech Announces New Composition of Matter Patent for PDS0101 in Japan

Rhea-AI Summary

PDS Biotechnology (Nasdaq: PDSB) announced that the Japan Patent Office issued Patent No. 7783866 for PDS0101 on Dec 9, 2025, granting broad composition-of-matter and methods-of-use claims.

The patent expands previously granted Japanese protections and adds to a global IP estate that includes granted patents in the United States, China, Australia, and Hong Kong, with additional applications pending in other countries. The company said this, together with anticipated biologics exclusivity in the United States, provides patent and market protections for PDS0101 into the 2040s. PDS0101 is in a Phase 3 trial studying PDS0101 plus pembrolizumab for HPV16-positive recurrent/metastatic head and neck cancer.

Positive

• Japan Patent No. 7783866 issued on Dec 9, 2025
• Patent grants broad composition-of-matter and methods-of-use claims
• Adds to granted patents in US, China, Australia, Hong Kong
• Company states anticipated market protections into the 2040s
• PDS0101 is enrolled in a Phase 3 trial with pembrolizumab for HPV16-positive recurrent/metastatic head and neck cancer

Negative

• No Phase 3 efficacy readout date or clinical results disclosed
• Biologics exclusivity described as anticipated, not a confirmed granted term

Key Figures

Shelf registration size $200.0 million Form S-3 shelf filed 2025-08-29

ATM sales agreement $20.0 million Separate sales agreement prospectus under S-3

ATM capacity $50.0 million At-the-market program with B. Riley and H.C. Wainwright

Cash and equivalents $26.2 million As of September 30, 2025 (Q3 2025 10-Q)

Q3 2025 net loss $9.0 million Quarter ended September 30, 2025

Nine-month net loss $26.9 million Nine months ended September 30, 2025

Convertible debentures $22,222,222 Senior secured convertible debentures issued April 30, 2025

Effective interest rate 24.1% Annual rate on debentures as of Q3 2025

Market Reality Check

$1.02 Last Close

Volume Volume 357,942 is 0.38x the 20-day average of 933,930, suggesting limited pre‑news activity. low

Technical Shares at 0.8983, trading below the 200-day MA of 1.18 and 60.63% under the 52-week high.

Peers on Argus

PDSB gained 3.25% while peers were mixed: CUE -3.15%, CAMP +8.31%, MAIA +2.5%, PYPD -0.5%, VTVT +8.66%, pointing to a stock-specific driver.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 02	Regulatory meeting news	Positive	+7.0%	FDA accepted Type C meeting to discuss Phase 3 endpoint and potential acceleration.
Nov 13	Earnings and pipeline	Negative	-12.3%	Reported Q3 losses, limited cash, alongside clinical updates and trial strategy plans.
Nov 11	Registered direct offering	Negative	+8.8%	Dilutive registered direct equity/warrant financing to fund Phase 3 and operations.
Nov 10	Clinical data update	Positive	+7.0%	SITC data showed immune activation and biomarkers linked to clinical benefit.
Nov 06	Earnings call scheduling	Neutral	-1.8%	Announcement of upcoming Q3 results call and webcast logistics only.

Pattern Detected

Recent news has often produced sizable moves, with positive clinical/regulatory updates and negative financing/liquidity items both driving double‑digit percentage reactions, and one financing event showing a positive divergence.

Recent Company History

Over the last month, PDSB has reported multiple developments around its HPV16‑targeted programs and financing. A Nov 6 call announcement had little impact, but positive translational data on Nov 10 and a registered direct offering on Nov 11 both saw strong upside moves. Q3 results and liquidity details on Nov 13 were followed by a double‑digit decline, while the Dec 2 FDA Type C meeting news produced a solid gain. The new Japanese patent builds on this sequence of pipeline‑focused milestones.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-08-29

$200.0 million registered capacity

An effective Form S-3 filed on 2025-08-29 allows PDSB to offer up to $200.0 million in various securities, including up to $20.0 million via a dedicated sales agreement and an additional at‑the‑market program of up to $50.0 million. The shelf runs until 2028-08-29 and has been used at least once via a 424B5 on 2025-11-12.

Market Pulse Summary

The stock surged +18.0% in the session following this news. A strong positive reaction aligns with the company’s pattern of sizable moves on pipeline and regulatory milestones, as seen after prior clinical updates and FDA meeting news. However, the presence of a $200.0 million shelf and past use of best‑efforts offerings highlight ongoing financing needs that could introduce dilution. Historical reactions to financings have been mixed, so sustainability of gains has depended on maintaining confidence in PDS0101’s late‑stage path.

Key Terms

composition of matter regulatory

"issued Patent No. 7783866 for PDS0101 granting broad composition of matter"

Composition of matter describes the specific chemical makeup and structure of a substance — essentially the “recipe” of which atoms or molecules are present and how they are arranged. For investors, it matters because that precise recipe is what patents, regulatory approvals, and product claims protect; control over a unique composition can create market exclusivity, influence manufacturing costs, and drive a company’s valuation or licensing potential.

biologics exclusivity regulatory

"Together with anticipated biologics exclusivity in the United States"

A fixed regulatory period during which a licensed biological medicine has protection from approval of competing copycat products, meaning health authorities will not approve follow-on versions using the original data. It matters to investors because this temporary “no-entry” window shields sales and profits from direct competition, similar to a short-term monopoly, and therefore influences a drug maker’s revenue forecast, valuation and the timing of future competitors entering the market.

intellectual property technical

"adds to the Company’s robust intellectual property estate"

Intellectual property are legal rights that protect creations of the mind—such as inventions, brand names, designs, software, or secret formulas—giving the owner control over who can use, copy or sell them. For investors, IP is like owning a blueprint or recipe: it can generate steady income through exclusive sales or licensing, boost a company’s competitive edge and valuation, and also create costs or risks if rights must be defended or challenged in court.

Phase 3 medical

"PDS0101 is currently being studied in the Company’s Phase 3 trial"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

recurrent/metastatic medical

"in HPV16-positive recurrent/metastatic head and neck cancer"

Recurrent/metastatic describes cancer that has returned after initial treatment (recurrent) or has spread from its original site to other parts of the body (metastatic), making it generally more difficult to cure. For investors, this label defines a patient group with high, often urgent medical need, shapes clinical trial goals and the approval pathway for new drugs, and helps estimate market size and potential revenue for therapies aimed at later-stage disease.

immunotherapy medical

"a late-stage immunotherapy company focused on transforming how the immune system"

Treatment that uses or enhances the body’s immune system to detect and fight disease, most often cancers or chronic infections; think of it as training or arming the body’s own soldiers to find and destroy targets. It matters to investors because successful immunotherapies can lead to high-value drug approvals, recurring revenue from long-term treatments, and changes in competitive dynamics, while failures or safety issues in clinical trials can materially affect company valuations.

HPV vaccination medical

"Long-term impact of HPV vaccination and COVID-19 pandemic on oropharyngeal"

HPV vaccination protects against human papillomavirus, a common virus that can cause genital warts and several cancers. Think of it as preventive maintenance for public health: by reducing future disease, it cuts long‑term treatment costs and shapes demand for medicines and clinics. Investors watch uptake, approval, pricing and public programs because they directly affect revenue, market size, regulatory risk and potential legal exposure for vaccine makers and healthcare providers.

modeling study technical

"The Lancet Regional Health – Americas. 2022;8:100143. A modeling Study."

A modeling study uses mathematical formulas or computer simulations to estimate how a situation might unfold when real-world testing is impractical or too slow. Like a flight simulator for a business or medical scenario, it helps predict outcomes, test assumptions and explore risks under different conditions. Investors use modeling studies to judge likely revenues, costs, regulatory impacts or market demand and to decide whether potential rewards justify the risks.

AI-generated analysis. Not financial advice.

New Patent Grants Broad Composition Claims for PDS0101

Previously Granted Patent Protections and Anticipated Market Exclusivity Provide Protection for PDS0101 in the United States into the 2040s

PRINCETON, N.J., Dec. 09, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced that the Japan Patent Office has issued Patent No. 7783866 for PDS0101 granting broad composition of matter and methods of use claims. The new patent expands previously granted patents in Japan, and adds to the Company’s robust intellectual property estate, which includes previously granted patents in the United States, China, Australia, and Hong Kong. The Company has additional patent applications pending in several other countries. Together with anticipated biologics exclusivity in the United States, the Company has patent and market protections for PDS0101 into the 2040s.

The incidence of HPV16-related cancers is rapidly increasing in the US and Europe and also increasing globally.* PDS0101 is currently being studied in the Company’s Phase 3 trial for PDS0101 + pembrolizumab in HPV16-positive recurrent/metastatic head and neck cancer.

“The issuance of an additional patent for PDS0101 in Japan further strengthens our global IP portfolio and reinforces the robust intellectual property position supporting our growth. This marks an important step in protecting the value of our innovative immunotherapies as we advance our pipeline worldwide.” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotechnology.

The Company intends to continue to advance broad intellectual property protections for PDS0101 and its other investigational agents in development.

*Damgacioglu H, Sonawane K, Chhatwal J, et al. Long-term impact of HPV vaccination and COVID-19 pandemic on oropharyngeal cancer incidence and burden among men in the USA: A modeling Study. The Lancet Regional Health – Americas. 2022;8:100143.

About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company has initiated a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy PDS0101 (Versamune^® HPV) is being developed in combination with a standard-of-care immune checkpoint inhibitor, and in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.

For more information, please visit www.pdsbiotech.com

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to conduct clinical trials for PDS0101 (Versamune^® HPV), PDS01ADC, PDS0103 (Versamune^® MUC1) and other Versamune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101 (Versamune^® HPV), PDS01ADC, PDS0103 (Versamune^® MUC1) and other Versamune^® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s or its partners’ ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding response rates, the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Versamune^® is a registered trademark of PDS Biotechnology Corporation.

Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com

Media Contact:
David Schull
Russo Partners
Phone +1 (858) 717-2310
Email: david.schull@russopartnersllc.com

FAQ

What patent did PDSB announce on Dec 9, 2025?

PDSB announced that the Japan Patent Office issued Patent No. 7783866 for PDS0101 on Dec 9, 2025.

How long does PDSB say PDS0101 will be protected in the US?

The company said patent plus anticipated biologics exclusivity provide protections for PDS0101 into the 2040s.

Which countries already have granted patents for PDS0101 according to PDSB?

PDSB listed granted patents in the United States, China, Australia, and Hong Kong and pending applications elsewhere.

What clinical trial is PDS0101 currently in as of Dec 9, 2025?

PDS0101 is being studied in a Phase 3 trial evaluating PDS0101 plus pembrolizumab for HPV16-positive recurrent/metastatic head and neck cancer.

Does the Dec 9, 2025 announcement include Phase 3 results or a readout date for PDS0101?

No; the announcement notes the Phase 3 study is ongoing but does not provide efficacy data or a readout date.

What is the Nasdaq ticker for PDS Biotechnology referenced in the announcement?

The company trades under the ticker PDSB on Nasdaq.