On August 11, 2026 Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company" or "Sona") reported that it has closed its over-subscribed private placement that was announced on July 31, 2026 with the issuance of 8,423,372 common shares (each, a "Share") at $0.30 per share. (the "Financing"). All securities issued pursuant to the Financing will be subject to a hold period of four months and one day from the date of issuance.

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As previously disclosed, Sona intends to use the net proceeds of the Financing for advancing studies to support the clinical advancement and continuing research and development work on its Targeted Hyperthermia TherapyTM ("THT") oncology treatment, as well as for general working capital purposes.

Directors of the Company subscribed for 300,000 shares. Such participation is considered to be "related party transactions" within the meaning of Multilateral Instrument 61-101 Protection of Minority Security Holders in Special Transactions ("MI 61-101"). The Company relied on the exemptions from the formal valuation and minority shareholder approval requirements of MI 61-101 contained in sections 5.5(a) and 5.7(1)(a) of MI 61-101 in respect of related party participation in the Offering as neither the fair market value (as determined under MI 61-101) of the subject matter of, nor the fair market value of the consideration for, the transaction, insofar as it involves the related parties, exceeded 25% of the Company’s market capitalization (as determined under MI 61-101).

(Press release, Sona Nanotech, AUG 11, 2026, View Source [SID1234669954])

On August 11, 2026 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage biotechnology company developing transformative therapies for the treatment of cancer and rare diseases, reported financial results for the second quarter ended June 30, 2026 and provided a business update.

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"In the second quarter, we strengthened our late-stage pipeline through continued clinical and operational execution, positioning us for multiple important clinical and regulatory milestones over the coming quarters," said Jesse Shefferman, Chief Executive Officer at Protara Therapeutics. "We continue to make progress in the ADVANCED-2 trial and expect to complete enrollment in the fourth quarter of 2026. We remain confident that TARA-002 will be a preferred treatment option in the non-muscle invasive bladder cancer (NMIBC) BCG-Unresponsive setting and we are redesigning ADVANCED-3 to be a multi-cohort, open-label, exploratory trial, which will allow us to study TARA-002 in a broader high-grade, high-risk NMIBC patient population. The redesigned ADVANCED-3 protocol is expected to accelerate and expand the breadth of data available at or around the time of the potential launch of TARA-002 in BCG-Unresponsive carcinoma in situ (CIS) patients."

Mr. Shefferman added, "We also advanced our rare disease programs during the quarter. We recently presented encouraging interim durability and safety data from the STARBORN-1 pivotal trial of TARA-002 in Lymphatic Malformations (LMs) and, following discussions with the FDA, expect to submit our Biologics License Application (BLA) in the second half of 2027. At the same time, enrollment in the THRIVE-3 registrational trial evaluating IV Choline Chloride continues as planned, with interim results expected in the fourth quarter of this year. As we continue to execute across our portfolio, we believe we are well positioned to deliver a series of important clinical, regulatory and operational catalysts that have the potential to create meaningful value for patients and shareholders."

Recent Progress and Highlights

TARA-002 in NMIBC

● The Company expects to complete enrollment of the BCG-Unresponsive cohort in the fourth quarter of 2026.

● The Company is redesigning the recently initiated ADVANCED-3 trial to be a multi-cohort, open-label, exploratory trial to evaluate the efficacy and safety of intravesical TARA-002 in high-grade, high-risk BCG-Naïve and BCG-Exposed CIS (± Ta/T1) patients and papillary (Ta/T1) patients across BCG exposures. Importantly, this new design allows Protara to accelerate and expand the breadth of TARA-002 data in a broader high-grade, high-risk NMIBC patient population.

TARA-002 in LMs

● Protara presented updated interim safety and durability data from the ongoing Phase 2 STARBORN-1 trial evaluating TARA-002 in pediatric patients with macrocystic and mixed cystic LMs in a poster session at the International Society for the Study of Vascular Anomalies World Congress in Philadelphia, Pennsylvania. As of an April 10, 2026 data cutoff:

○ TARA-002 demonstrated clinical success in 83% (10/12) of participants that completed treatment and in 100% (10/10) of evaluable patients. All seven participants that reached the 32-week post-treatment assessment remained disease free as of the data cutoff.

○ The majority of AEs were mild to moderate, with no serious AEs reported. The most common AEs were swelling and fatigue, and most were transient and resolved within a few days.

● Based on engagement with the FDA under Breakthrough Therapy designation, the Company intends to submit a BLA for TARA-002 in LMs based on the results of the pivotal STARBORN-1 trial in the second half of 2027 and will continue to submit safety and efficacy data from the trial on an ongoing basis to support the FDA’s evaluation of the risks and benefits of TARA-002 in LMs.

IV Choline Chloride for Patients on Parenteral Support (PS)

● THRIVE-3, the Company’s registrational Phase 3 clinical trial, is ongoing, and the Company expects to report interim results in the fourth quarter of 2026.

Second Quarter 2026 Financial Results

● As of June 30, 2026, unrestricted cash and cash equivalents and marketable debt securities totaled $161.9 million. The Company expects its cash and cash equivalents and marketable debt securities will be sufficient to fund its planned operations and milestones into 2028.

● Research and development expenses for the second quarter of 2026 increased to $17.0 million from $10.8 million for the prior year period. This increase was primarily due to higher direct costs associated with ongoing clinical trials of $3.2 million, increased personnel-related expenses of $1.8 million and increased non-program specific research and development expenses, primarily attributable to chemistry, manufacturing and controls of $1.2 million.

● General and administrative expenses for the second quarter of 2026 increased to $6.4 million from $5.8 million for the prior-year period. The increase was primarily due to an increase in personnel-related expenses of $0.7 million, offset by a decrease in other general and administrative expenses of $0.1 million.

● For the second quarter of 2026, Protara incurred a net loss of $21.7 million, or $0.36 per share, compared with a net loss of $15.0 million, or $0.35 per share, for the prior-year period.

About TARA-002

TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and of LMs, for which it has been granted Rare Pediatric Disease, Orphan Drug, Breakthrough Therapy and Fast Track designations by the FDA. TARA-002 is a first-in-class TLR2/NOD2 agonist and novel immunopotentiator derived from inactivated Streptococcus pyogenes with a mechanism of action that includes the activation of innate and adaptive immune pathways within the bladder wall. When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a pro-inflammatory response with the release of cytokines such as tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma, IL-6, IL-10 and IL-12. TARA-002 also directly kills tumor cells and triggers a host immune response by inducing immunogenic cell death, which further enhances the antitumor immune response.

TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil in Japan by Chugai Pharmaceutical Co., Ltd.

About Non-Muscle Invasive Bladder Cancer

Bladder cancer is the sixth most common cancer in the United States, with non-muscle invasive bladder cancer (NMIBC) representing approximately 80% of bladder cancer diagnoses, or approximately 65,000 patients in the U.S. each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle. Patients suffering from high-grade, high-risk NMIBC face high rates of disease recurrence and are potentially subject to full removal of the bladder (cystectomy).

About Lymphatic Malformations

Lymphatic Malformations (LMs) are rare, congenital malformations of lymphatic vessels resulting in the failure of these structures to connect or drain into the venous system. Protara’s focus is on macrocystic and mixed cystic LMs, for which there are no currently approved therapies. More than 50% of LMs are detected at birth and 90% diagnosed before the age of three years. The most common morbidities and serious manifestations of the disease include compression of the upper aerodigestive tract, including airway obstruction requiring intubation and possible tracheostomy dependence; intralesional bleeding; impingement on critical structures, including nerves, vessels and lymphatics; recurrent infection; and cosmetic and other functional disabilities. TARA-002 has been granted Rare Pediatric Disease, Orphan Drug, Breakthrough Therapy and Fast Track designations by the FDA for the treatment of LMs.

About IV Choline Chloride for Patients on Parenteral Support

IV Choline Chloride is an investigational, intravenous phospholipid substrate replacement therapy in development for patients receiving parenteral support (PS). Choline is an important substrate for phospholipids that are critical for healthy liver function and play an important role in modulating gene expression, cell membrane signaling, brain development and neurotransmission, muscle function and bone health. There are currently no available PS formulations containing choline. IV Choline Chloride has the potential to become the first FDA approved IV choline formulation for PS patients. It has been granted Orphan Drug designation by the FDA for the prevention and/or treatment of choline deficiency in patients on long-term parenteral nutrition and has been granted Fast Track designation as a source of choline when oral or enteral nutrition is not possible, insufficient or contraindicated. The U.S. Patent and Trademark Office has issued Protara a U.S. patent claiming a choline composition and a U.S. patent claiming a method of treating choline deficiency with a choline composition, each with a term expiring in 2041.

(Press release, Protara Therapeutics, AUG 11, 2026, View Source [SID1234669953])

On August 11, 2026 Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, reported its financial results for the second quarter ended June 30, 2026 and provided an update on its R&D pipeline and other corporate developments.

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"The first six months of 2026 were highlighted by steady and strong execution across our organization," stated Kris Vaddi, Ph.D., Chief Executive Officer of Prelude. "We’ve made considerable progress advancing our three core programs. Notably, we are well positioned to initiate, in the fourth quarter, the first clinical trial of our highly differentiated, selective KAT6A degrader, PRT13722 in HR+ breast cancer. Enrollment in our phase 1 study of PRT12396, our mutant-selective JAK2V617F inhibitor, continues, and we are also making excellent progress toward advancing the lead development candidates from our mCALR degrader antibody conjugate program."

Program Updates and Upcoming Milestones

Highly selective KAT6A oral degrader program

KAT6 is an emerging and recently validated target in the treatment of HR+ breast cancer. Prelude discovered and is developing first-in-class, highly potent, highly selective and orally bioavailable KAT6A selective degraders. Pending clearance of the IND application, the Company expects the phase 1 study initiation of PRT13722 in HR+ breast cancer in the fourth quarter of 2026. Prelude believes that selectively degrading KAT6A has the potential for improved efficacy, tolerability and combinability with other agents relative to non-selective inhibitors of KAT6A/B.

The Company presented preclinical data supporting this hypothesis at the AACR (Free AACR Whitepaper) Annual Meeting 2026. The presentation can be found at Publications – Prelude Therapeutics.

Mutant selective JAK2V617F JH2 inhibitor program

JAK2V617F is the primary driver mutation responsible for disease progression in the majority of patients living with myeloproliferative neoplasms (MPNs). The mutation impacts approximately 95% of patients with polycythemia vera (PV), 60% of patients with essential thrombocythemia (ET) and 55% of patients with myelofibrosis (MF). Identifying JAK2 JH2 inhibitors that selectively target V617F+ cells has long been the goal for advancing the treatment of MPNs. Prelude has designed and identified novel allosteric inhibitors that bind into the JAK2 JH2 "deep pocket" where the V617F mutation resides. These candidates demonstrate mutant specific inhibition in multiple preclinical models of MPNs. Prelude believes this approach may have the potential to reduce mutant allele burden, slow or even reverse disease progression, and transform treatment outcomes for MPN patients.

PRT12396, Prelude’s lead, mutant-selective JAK2V617F inhibitor, received IND clearance from the U.S. Food and Drug Administration, as previously announced in February 2026 and is currently enrolling patients into a Phase 1 study of PRT12396 in patients with PV and MF. The Company also continues to make progress advancing next generation development candidates with potential best-in-class selectivity profiles.

The JAK2V617F inhibitor program is subject to an exclusive option agreement with Incyte announced in November 2025.

Mutated calreticulin (mCALR) DAC discovery program

Mutant CALR is a neoantigen presented on the cell surface of malignant myeloid cells but not normal cells and is found in approximately 25-35% of patients with MF and essential thrombocythemia (ET). Recently, a mCALR-targeted monoclonal antibody demonstrated robust clinical activity in high-risk ET patients. Prelude is advancing mCALR-targeted degrader antibody conjugates (DACs) using the Company’s proprietary degrader payloads as a differentiated approach for patients with CALR mutations. This discovery program is wholly owned and controlled by Prelude.

The Company presented the preclinical data from the program at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress in June and the American Society of Hematology (ASH) (Free ASH Whitepaper) 67th Annual Meeting in December 2025. The presentations can be found at Publications – Prelude Therapeutics.

Degrader payloads for next generation DACs

Prelude is leveraging our expertise in targeted protein degradation to discover and develop novel degrader payloads for use with next generation DACs. We have developed highly potent SMARCA2/4 and CDK9 degrader payloads optimized for efficacy, tolerability and developability when coupled to a wide range of different antibodies. Building on our existing DAC partnership with AbCellera, the Company’s payloads and corresponding payload-linkers are available for licensing to additional partners to expand the reach of this new technology.

We have recently published preclinical data demonstrating that next generation DACs using Prelude degrader payloads have potential for significantly better in vivo efficacy and tolerability compared to traditional cytotoxic ADCs when tested head-to-head in xenograft models. These data can be found at: Publications – Prelude Therapeutics

Corporate Updates

In April 2026, the Company announced the appointment of Charles Morris, M.D. as Chief Medical Officer.

Second Quarter 2026 Financial Results 

Cash, Cash Equivalents, Restricted cash and Marketable securities:

Cash, cash equivalents, restricted cash and marketable securities as of June 30, 2026 were $155.2 million. The Company anticipates that its existing cash, cash equivalents, restricted cash and marketable securities will fund Prelude’s operations into the second quarter of 2028.

Research and Development (R&D) Expenses:

For the three months ended June 30, 2026, R&D expense decreased to $16.1 from $25.8 million for the prior year period. Included in the R&D expense for the three months ended June 30, 2026 was $1.0 million of non-cash expense related to stock-based compensation expense, including employee stock options, compared to $2.2 million for the three months ended June 30, 2025. Along with the decrease in stock-based compensation expense, the decrease was primarily related to lower expense incurred for our SMARCA2 clinical trials which we paused in 2025 along with a decrease in employee related expenses due to a workforce reduction in the second half of 2025. Research and development expenses may fluctuate from period to period depending upon the stage of certain projects and the level of preclinical and clinical trial-related activities.

General and Administrative (G&A) Expenses:

For the three months ended June 30, 2026, G&A expenses decreased to $5.0 million from $6.4 million for the prior year period. Included in general and administrative expenses for the three months ended June 30, 2026, was $1.0 million of non-cash expense related to stock-based compensation expense, including employee stock options, compared to $1.6 million for the three months ended June 30, 2025. The decrease in general and administrative expenses was primarily due to a decrease in stock-based compensation along with a decrease in employee-related expenses.

Net Loss:

For the three months ended June 30, 2026, net loss was $13.9 million, or $0.14 per share compared to $31.2 million, or $0.41 per share, for the prior year period. Included in the net loss for the three months ended June 30, 2026, was $2.0 million of non-cash expenses related to the impact of expensing share-based payments, including employee stock options due in part to fewer employees, as compared to $3.8 million for the same period in 2025.

(Press release, Prelude Therapeutics, AUG 11, 2026, View Source [SID1234669952])

On August 11, 2026 Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company focused on the discovery and development of integrin-based therapeutics, reported a corporate update and announced second quarter 2026 financial results.

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"In the second quarter, we continued to execute across the portfolio, led by strong enrollment in FORTIFY," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. "With the appointments of Flavia and Robert to the board, Pliant now has deep global oncology drug development and commercialization expertise at this important time for our oncology program. We continue to make progress on our proprietary integrin-targeted drug-delivery platform and look forward to sharing more information on the platform soon."
Oncology Program
PLN-101095 is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to overcome checkpoint resistance by blocking TGF-β activation in the tumor microenvironment. Pliant is currently conducting FORTIFY, a Phase 1a/1b open-label, dose-escalation and indication expansion trial (NCT0670706), to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of PLN-101095, in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors.

•Enrollment continues in FORTIFY, a Phase 1b indication expansion trial. FORTIFY will enroll up to 102 patients across three cohorts including non-small cell lung cancer (NSCLC), clear cell renal cell carcinoma (ccRCC) and tumors with high tumor mutational burden. Patients are treated for 14 days with PLN-101095 dosed at 1,000 mg twice daily as monotherapy, after which pembrolizumab is added as combination therapy. Enrollment remains strong, progressing ahead of schedule. Interim data is expected in 2027.

•Oral presentation at AACR (Free AACR Whitepaper) of updated PLN-101095 Phase 1 data highlights monotherapy biomarker data showing a coordinated T-cell reactivation cascade in responders. In July, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s (AACR) (Free AACR Whitepaper) Drug Discovery and Development conference, the Company reviewed encouraging PLN-101095 Phase 1 monotherapy biomarker data. As previously reported, all responding patients showed large increases in plasma interferon gamma (IFN-γ), a modulator of anti-tumor immunity, after 14 days of monotherapy with PLN-101095. Updated data show that blocking of αvβ8 by PLN-101095 also resulted in increases in CXCL9, a recruiter of T cells, and granzyme-B, a marker for cytotoxic arming in responding patients. Increased IFN-γ, CXCL9 and granzyme-B after PLN-101095 monotherapy signals a shift in the tumor microenvironment that could potentially resensitize tumors to pembrolizumab. Importantly, no non-responders experienced increases in these biomarkers.

Integrin-Targeted Delivery Platform

•Utilizing cell-specific integrin receptors, Pliant has developed a platform to deliver drug payloads, including siRNAs, to selective tissue types. Current programs are focused on delivering siRNAs to skeletal muscle cells and other tissues. Preclinical proof-of-concept studies are currently ongoing. The Company believes this integrin-targeting drug-delivery platform has the potential for broad applicability across multiple disease areas utilizing a variety of drug payloads. Pliant plans to provide additional detail on the platform and path forward, including initial treatment indications, in the second half of 2026.

Corporate Highlights
•Appointed Flavia Borellini, Ph.D. and Robert Iannone, M.D., M.S.C.E. to the Company’s Board of Directors. Dr. Borellini brings more than 25 years of executive management experience in the biopharmaceutical industry with a focus on the global development of targeted oncology drugs from preclinical to commercial stage. Dr. Iannone, who currently serves as Executive Vice President, Research and Development and Chief Medical Officer at Jazz Pharmaceuticals, brings more than two decades of executive drug development and regulatory leadership, including the approval of several targeted and immuno-oncology medicines.

Second Quarter 2026 Financial Results
•Research and development expenses were $16.7 million, as compared to $32.2 million for the prior-year quarter. The decrease was primarily due to completing close-out activities for BEACON-IPF, a Phase 2b/3 study of bexotegrast, in 2025 and reduced personnel-related expenses, including stock based compensation, driven by decreased headcount compared to prior year.
•General and administrative expenses were $7.1 million, as compared to $13.4 million for the prior-year quarter. The decrease was primarily due to personnel-related expenses, including stock-based compensation, driven by decreased headcount compared to prior year.
•Net loss was $22.4 million as compared to $43.3 million for the prior-year quarter. The decrease was primarily due to significantly lower operating expenses following the termination of bexotegrast development in IPF in 2025 and decreased personnel-related expenses, including stock-based compensation, driven by reduced headcount compared to prior year.
•As of June 30, 2026, the Company had cash, cash equivalents and short-term investments of $159.6 million which the Company expects to be sufficient to fund operations into the second half of 2028.

(Press release, Pliant Therapeutics, AUG 11, 2026, View Source [SID1234669951])

On August 11, 2026 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on developing targeted immunotherapies for cancer, reported a Letter to Shareholders from Frank Bedu-Addo, Ph.D., Chief Executive Officer and Director of PDS Biotech:

"Dear Fellow Shareholders,

Over the past several months, our Board of Directors and management team conducted a comprehensive review of our development portfolio, capital allocation priorities and long-term strategy. Following this review, we believe the best path to creating long-term shareholder value is to prioritize the advancement of PDS0301, our tumor-targeted immunocytokine, while pursuing strategic partnership opportunities for PDS0101.

The oncology treatment landscape is rapidly evolving with the emergence of various precision medicines. Despite these advances, treatment resistance and limited durability of response remain significant challenges for many patients with advanced solid tumors. Based on supportive preclinical and clinical data, we believe PDS0301 has the potential to address these challenges by precisely targeting and remodeling the tumor microenvironment, potentially enhancing the effectiveness and durability of current and emerging oncology therapies. To address this medical need, we have designed PDS0301 for use, in combination with other oncology therapies, to remodel the tumor microenvironment to potentially promote more effective anti-tumor responses in patients. We believe the remodeling of the tumor microenvironment is an important factor in addressing treatment resistance and reversing disease progression. Further, this mechanism could enable PDS0301 to complement a broad range of current and emerging oncology therapies, including RAS pathway inhibitors, bispecific antibodies, ADCs and radioligand therapies.

We concluded that our resources should be redirected toward PDS0301, where we believe the combination of encouraging clinical data, development opportunity and capital requirements provide a potentially more attractive path to long-term shareholder value.

Phase 2 mCRC Results

Patients with metastatic microsatellite stable (MSS) and mismatch repair-proficient (pMMR) colorectal cancer, particularly those with liver metastases, continue to face substantial unmet medical needs, and median overall survival is reported to be less than 10 months and objective response rates (ORR) less than 25%1. Clinical data generated in collaboration with the National Cancer Institute demonstrated encouraging and durable activity, including a 71% ORR at 6 months and an 80% 24-month survival rate in patients with metastatic MSS and pMMR colorectal cancer and liver metastases2. Together with safety observed in more than 380 treated patients, these findings strengthen our conviction that PDS0301 has the potential to address one of the more significant limitations of current oncology therapies.

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Strategic Partnering Opportunities for PDS0101

We have decided that we will cease further internal investment in the PDS0101 Phase 3 VERSATILE-003 trial, including the discontinuation of the VERSATILE-003 Phase 3 trial, and intend to pursue strategic partnerships or other externally funded opportunities for the continued development of PDS0101. This decision follows a comprehensive assessment of the capital, time and resources required to complete the Phase 3 trial and support commercialization of PDS0101. This decision reflects our commitment to disciplined capital allocation rather than a change in our view of the underlying PDS0101 science and clinical data. We believe the strength of the Phase 2 clinical results allows us to preserve the potential value of PDS0101 through a strategic partnership.

Why We Believe PDS0301 Represents Our Greatest Opportunity

Our objective is to establish PDS0301 as a foundational component of next-generation oncology therapies for multiple difficult-to-treat solid tumors.

We believe PDS0301 offers several important differentiators:

•
Encouraging efficacy as a single agent (monotherapy) in advanced, recurrent cancer.

•
Encouraging efficacy with chemotherapy in difficult-to-treat metastatic colorectal cancer.

•
More than 380 patients treated with an encouraging safety and tolerability profile.

•
A mechanism designed to remodel the tumor microenvironment and to reshape the anti-tumor immune response in patients, leading to more effective and more durable or long-lasting therapy. The mechanism also has the potential to improve the durability of ADCs, bispecific antibodies, radioligands, targeted therapies and immunotherapies.

•
Clinical activity and tolerability observed across multiple difficult-to-treat solid tumors as a single agent and in double and triple combinations.

•
A Phase 2b development strategy designed to take into account feedback from the FDA.

Although metastatic colorectal cancer is our lead development program, our maturing clinical data in various solid tumors suggests that PDS0301 may have broader application. By targeting the tumor microenvironment rather than a single oncogenic pathway, PDS0301 appears to have applicability across multiple difficult-to-treat solid tumors which could result in several combination oncology therapy strategies.

Beyond colorectal cancer, PDS0301 is also being evaluated in recurrent prostate cancer, metastatic castration resistant prostate cancer, Kaposi sarcoma, HPV16-positive cancers, and other National Cancer Institute-sponsored clinical trials, providing additional opportunities to demonstrate the breadth of PDS0301.

Looking Ahead

A randomized Phase 2b trial with PDS0301 has been designed taking into account feedback received from the FDA and is intended to generate meaningful clinical data with disciplined capital investment.

Over the next 18 to 24 months, we expect to:

•
Advance PDS0301 through a randomized Phase 2b development program.
•
Identify and assess strategic partnering opportunities for PDS0101.

•
Maintain disciplined capital allocation while delivering meaningful clinical and business milestones.

We believe PDS Biotechnology is well positioned at the intersection of one of oncology’s most important emerging trends: improving the effectiveness and durability of oncology therapies through precision remodeling of the tumor microenvironment. By focusing our resources on PDS0301, identifying strategic partnerships for PDS0101, and executing with financial discipline, we believe we can create meaningful long-term value for both patients and shareholders. We look forward to updating you on our progress as we move forward with this new strategy."

Sincerely,

Frank Bedu-Addo, Ph.D.
Chief Executive Officer, Director

PDS Biotechnology will announce its financial results for the quarter ending June 30, 2026, on August 13, 2026.

(Press release, PDS Biotechnology, AUG 11, 2026, View Source [SID1234669950])