On May 8, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pipeline and business progress, reiterated key anticipated milestones, and announced first quarter 2025 financial results (Press release, Nuvalent, MAY 8, 2025, View Source [SID1234652755]).

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"2025 is a critical year of execution for Nuvalent as we continue to transition toward becoming a fully integrated commercial-stage biopharmaceutical company," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "We expect multiple meaningful milestones this year, including pivotal data for TKI pre-treated patients from both of our parallel lead programs, and our first potential NDA submission for zidesamtinib for TKI pre-treated patients with ROS1-positive NSCLC."

Dr. Porter continued, "The continued progress across our portfolio is a direct reflection of the strength and dedication of our team—it is their deep expertise, operational excellence, and commitment to patients that drive our ability to execute. In recognition of their significant contributions, we’re pleased to announce the leadership promotions of Ruth Adams to Senior Vice President, Clinical Operations; Dr. Joshua Horan to Senior Vice President, Chemistry; and Jessie Lin to Senior Vice President, Corporate Strategy and Portfolio Management. With strong product candidates, a solid financial position, and an experienced team unified by an unwavering commitment to patient impact, we believe we are well-positioned to achieve our goals."

Recent Pipeline and Business Highlights

ROS1 Program

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Evaluation of zidesamtinib, the company’s novel ROS1-selective inhibitor, is ongoing in the ARROS-1 Phase 1/2 trial for patients with advanced TKI-naïve and TKI pre-treated ROS1-positive non-small cell lung cancer (NSCLC) and other solid tumors. The company expects to report pivotal data for TKI pre-treated patients with advanced ROS1-positive NSCLC in the first half of 2025 in support of an anticipated New Drug Application (NDA) submission by mid-year 2025.
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A manuscript reinforcing the rational molecular design of zidesamtinib as a novel ROS1-selective inhibitor was published in Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), in conjunction with the presentation of new preclinical data at the AACR (Free AACR Whitepaper) meeting detailing the first crystal structure of ROS1 G2032R in complex with zidesamtinib. The crystal structure further supports zidesamtinib’s molecular design and provides structural insights into how the ROS1 G2032R mutation affects TKI binding. The publication additionally explores the activity of zidesamtinib and other approved or investigational ROS1 TKIs at clinically relevant concentrations against ROS1 resistance mutations, including the most commonly occurring resistance mutation, ROS1 G2032R, in preclinical mutagenesis screens and an intracranial ROS1 G2032R xenograft model. Findings presented in the manuscript show that, at clinically relevant concentrations, zidesamtinib suppressed on-target resistance in ENU mutagenesis screens simulating first-line and later-line treatment and inhibited ROS1 G2032R brain tumors more effectively than the other ROS1 TKIs evaluated.
ALK Program

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Evaluation of neladalkib, its novel ALK-selective inhibitor, is ongoing in the ALKOVE-1 Phase 1/2 trial for patients with advanced ALK-positive NSCLC and other solid tumors. The company expects to report pivotal data for TKI pre-treated patients with advanced ALK-positive NSCLC and other solid tumors by year-end 2025.
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Nuvalent presented new preclinical data at the AACR (Free AACR Whitepaper) Annual Meeting demonstrating that neladalkib suppressed resistance in ENU mutagenesis screens simulating first-line and later-line treatment.
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The company plans to initiate the ALKAZAR Phase 3 trial, its front-line development strategy for the company’s ALK program, in the first half of 2025. The Phase 3 ALKAZAR trial will be a global, randomized, controlled trial designed to evaluate neladalkib versus the current standard of care for the treatment of patients with TKI-naïve ALK-positive NSCLC. Patients will be randomized 1:1 to receive neladalkib monotherapy or ALECENSA (alectinib) monotherapy. The company will present a "Trial in Progress" poster including background and study design for ALKAZAR at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
HER2 Program

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Enrollment is ongoing in the HEROEX-1 Phase 1a/1b trial evaluating the overall safety and tolerability of NVL-330, the company’s novel HER2-selective inhibitor, for pre-treated patients with HER2-altered NSCLC. Additional objectives include determination of the recommended Phase 2 dose, characterization of NVL-330’s pharmacokinetic profile, and preliminary evaluation of anti-tumor activity. A "Trial in Progress" poster including background and study design for HEROEX-1 will be presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting.

Recent Leadership Promotions

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Ruth Adams, Promoted to Senior Vice President, Clinical Operations: Ruth joined Nuvalent in 2020, bringing more than 20 years of experience in research and development for oncology therapeutics. This promotion recognizes Ruth’s continued excellence in overseeing clinical trial execution, exemplified by her leadership in the global operationalization of Nuvalent’s ARROS-1, ALKOVE-1, HEROEX-1, and ALKAZAR studies.
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Joshua Horan, Ph.D., Promoted to Senior Vice President, Chemistry: Joshua joined the Nuvalent team in 2018, bringing more than 15 years of drug discovery experience spanning the fields of immunology, nephrology, proteopathy, and oncology. This promotion recognizes Joshua’s continued excellence in overseeing Nuvalent’s discovery chemistry program, which has generated three novel, potential best-in-class drug candidates and continues to advance an active discovery pipeline.
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Jessie Lin, Promoted to Senior Vice President, Corporate Strategy & Portfolio Management: Jessie has worked with the Nuvalent team since 2020, bringing 15 years of experience driving multidisciplinary strategic growth initiatives across the life sciences industry.

This promotion recognizes Jessie’s continued excellence in shaping and advancing Nuvalent’s mission of becoming a fully integrated biopharmaceutical company capable of discovering, developing, and delivering precisely targeted therapies for patients with cancer.

Upcoming Events

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TD Cowen 6th Annual Oncology Innovation Summit: Management will be participating in a virtual fireside chat on Tuesday, May 27, 2025 at 4:00 p.m. ET. A live webcast will be available in the Investors section of Nuvalent’s website at www.nuvalent.com, and will be archived for 30 days following the conference.

First Quarter 2025 Financial Results

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Cash Position: Cash, cash equivalents and marketable securities were $1.1 billion as of March 31, 2025. Nuvalent continues to believe its existing cash, cash equivalents and marketable securities will be sufficient to fund its current operating plan into 2028.
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R&D Expenses: Research and development (R&D) expenses were $74.4 million for the first quarter of 2025.
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G&A Expenses: General and administrative (G&A) expenses were $20.4 million for the first quarter of 2025.
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Net Loss: Net loss was $84.6 million for the first quarter of 2025.

On May 7, 2025 OmniAb, Inc. (NASDAQ: OABI) reported financial results for the three months ended March 31, 2025, and provided operating and partner program updates (Press release, OmniAb, MAY 8, 2025, View Source [SID1234652778]).

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"We have started the year with robust deal flow, including both platform and asset-based deals. Our business remains strong as our diversified pipeline of partner programs is progressing with recent and expected new clinical entrants and data readouts," said Matt Foehr, Chief Executive Officer of OmniAb. "Today we announced the xPloration Partner Access Program for OmniAb partners, enhancing the scalability of our technology platforms and creating new business opportunities that we believe will be accretive to both earnings and cash flow in short- and long-term. This initiative furthers our mission to push the frontiers of discovery technologies along with our focus on creating value for our partners and our stakeholders. As we look ahead, our 2025 outlook remains on track with our commitment to running an efficient and leverageable business."

First Quarter 2025 Financial Results

Revenue for the first quarter of 2025 was $4.2 million, compared with $3.8 million for the same period in 2024, with the increase primarily due to the recognition of a $1.0 million Phase 1 milestone payment and higher license fees, partially offset by lower service revenue.

Research and development expense was $12.6 million for the first quarter of 2025, compared with $14.6 million for the same period in 2024, with the decrease primarily due to lower share-based compensation expense and lower external expenses associated with our small-molecule ion channel programs and technology development. General and administrative expense was $7.9 million for the first quarter of 2025, compared with $8.3 million for the same period in 2024, with the decrease primarily due to lower legal fees and share-based compensation expense.

Net loss for the first quarter of 2025 was $18.2 million, or $0.17 per share, compared with a net loss of $19.0 million, or $0.19 per share, for the same period in 2024.

As of March 31, 2025, OmniAb had cash, cash equivalents and short-term investments of $43.6 million.

2025 Financial Guidance

OmniAb affirms guidance for 2025 revenue to be in the range of $20 million to $25 million, and revises operating expense guidance to be in the range of $85 million to $90 million from the previous range of $90 million to $95 million. In addition, OmniAb continues to expect 2025 cash use to be lower than cash use in 2024. Cash use in 2024 was $38.9 million, excluding the 2024 ATM issuance. The 2025 full year effective tax rate is expected to be approximately 0%.

First Quarter 2025 and Recent Business Highlights

During the first quarter of 2025, OmniAb entered into three new platform license agreements including the Wyss Institute at Harvard University, Takis Biotech S.r.l. and Orion Corporation.

OmniAb entered into a research collaboration and license agreement with Orion Corporation to discover and generate an antibody-based compound for a specific ion-channel target. Under the terms of the agreement, OmniAb will receive an upfront payment of $250,000 and is eligible to receive service payments. OmniAb is also eligible to receive development, regulatory and commercialization milestone payments totaling to over $55 million. OmniAb will receive low- to mid-single digit tiered royalties on net sales, should the program reach commercialization.

As of March 31, 2025, the Company had 95 active partners and 378 active programs, including 33 OmniAb-derived programs in clinical development or being commercialized.

Post-quarter close, OmniAb entered into an asset-based sale with Angelini Pharma for a small molecule Kv7.2 program. OmniAb will receive an upfront payment of $3 million, and potential milestones of over $170 million and royalties.

In addition, OmniAb launched the offering of xPloration to existing partners through a Partner Access Program. xPloration is a high-throughput single B-cell screening instrument that leverages machine learning and artificial intelligence to address challenges in primary B-cell screening with traditional methods, such as limited antibody diversity and lengthy processes. We believe it offers a competitive edge over current market offerings for B-cell screening with unmatched screening throughput, superior hit recovery, exceptional ease-of-use and reliability. OmniAb will showcase xPloration at the 21st Annual PEGS Boston Summit, taking place May 12-16 at the Omni Boston Hotel at the Seaport.

First quarter 2025 and recent partner and business highlights include the following:

IMVT-1402

Immunovant announced that potentially registrational trials for IMVT-1402 are currently enrolling patients in four indications: myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), Graves’ disease (GD) and difficult-to-treat rheumatoid arthritis.
A fifth potentially registrational trial for Sjogren’s disease is planned to begin in the summer of 2025. Additionally, a proof-of-concept study has been initiated in a sixth indication, cutaneous lupus erythematosus.
Batoclimab

Immunovant announced positive study results for batoclimab in MG and CIDP. The pivotal study in MG met its primary endpoint, showing a change from baseline in the Myasthenia Gravis Activities of Daily Living score in the acetylcholine receptor antibody positive population at 12 weeks. The 680mg dose arm showed a 5.6-point improvement with a 74% mean immunoglobulin G (IgG) reduction, while the 340mg dose arm showed a 4.7-point improvement with a 64% mean IgG reduction.
Initial CIDP results from Period 1, following standard-of-care washout, demonstrated a mean improvement in the adjusted Inflammatory Neuropathy Cause and Treatment (aINCAT) disability score of 1.8 across study arms. An 84% responder rate (with response defined as an aINCAT improvement ≥1) was observed among all patients whose IgG was reduced by ≥70%.
In both batoclimab studies, deeper IgG reductions correlated with better clinical outcomes across a range of assessments and timepoints.
Immunovant expects to announce additional data for batoclimab in GD, including six-month remission data, this summer. Additionally, top-line results for batoclimab from potentially registrational Phase 3 trials in thyroid eye disease are expected in the second half of 2025.
Sugemalimab

CStone Pharmaceuticals announced the submission of a Type II variation application to the European Medicines Agency (EMA) for sugemalimab, seeking approval for the treatment of unresectable stage III non-small cell lung cancer (NSCLC) in patients who have not progressed following platinum-based chemoradiotherapy. This is CStone’s second regulatory submission for sugemalimab to the EMA, following its 2024 approval for metastatic NSCLC.
TEV-53408

Teva Pharmaceuticals initiated a Phase 2 trial of TEV-53408 in adults with celiac disease. The primary efficacy objective is to assess the ability of TEV-53408 to attenuate gluten-induced enteropathy. Additional objectives include the safety assessment of TEV-53408.
RNDO- 564

Rondo Therapeutics published preclinical data for RNDO-564, a CD28 x Nectin-4 bispecific antibody for bladder cancer, in theJournal of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper).In vitrostudies demonstrated that RNDO-564 enhanced T-cell activation and cytotoxicity against Nectin-4 positive tumor cells. The antibody demonstrated significant tumor regression in tumor-bearing mouse models, both alone and with an immune checkpoint inhibitor. Favorable pharmacokinetic and tolerability profiles were observed in non-human primates.
OmniAb recently appointed Philip J. Gotwals, Ph.D., and Steve Crouse to its Board of Directors. Dr. Gotwals, with 30 years of biopharmaceutical experience in R&D, business development, product development, and therapeutic area strategy, along with Mr. Crouse, who brings over 20 years of expertise in life sciences sales and marketing, product development, business development, and general management, will help advance the Company’s strategic initiatives.

OmniAb reported that partners presented data on nine OmniAb derived molecules at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, held April 25-30. These presentations showcased clinical trial designs, as well as data across various preclinical and clinical studies.

The Company also expects that multiple partners will be presenting data from programs developed with OmniAb technology at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 30 – June 3, 2025.

Conference Call and Webcast

OmniAb management will host a conference call with accompanying slides today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (800) 549 8228 using the conference ID 96760. Slides, as well as the live and replay webcast of the call, are available at View Source

On May 8, 2025 Genmab reported Financial Results for the First Quarter of 2025 (Press release, Genmab, MAY 8, 2025, View Source [SID1234653889]).

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On May 8, 2025 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, reported financial results for the first quarter ended March 31, 2025 (Press release, Crinetics Pharmaceuticals, MAY 8, 2025, View Source [SID1234652740]).

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"Crinetics is stronger than we have ever been," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "We are approaching a pivotal moment in our company’s history. We are on-track with the FDA review and preparations for the anticipated launch of paltusotine for acromegaly, while also moving forward with multiple late-stage studies. We are excited to unveil our Phase 3 study for adult CAH patients aimed at demonstrating normalization of androstenedione levels with physiological glucocorticoid replacement to define an uncompromising standard of care in CAH. We’re also excited to start the clinical development program for CRN09682, the first candidate from our nonpeptide drug conjugate platform. We look forward to sharing more about this and our other early programs at our upcoming R&D Day. With a robust financial foundation and strong momentum across clinical, regulatory, and commercial fronts, we are poised to deliver on our mission of advancing innovative therapeutics to improve the lives of patients with endocrine diseases around the world."

First Quarter 2025 and Recent Highlights:
The review process for paltusotine’s New Drug Application (NDA) for acromegaly appears to be on track with productive and consistent engagement with the Food & Drug Administration (FDA).
Launch of CrinetiCARE patient support services platform and a patient-focused disease state education website.
Marketing authorization application (MAA) validated by the European Medicines Agency (EMA) for paltusotine for the treatment of acromegaly, consistent with a timeline for potential EMA decision in the first half of 2026. The EMA also granted Orphan Drug Designation (ODD) for paltusotine for the treatment of acromegaly, further highlighting the level of unmet need, and the potential for paltusotine to offer significant benefit to patients.
Phase 2 TouCAHn open-label study of atumelnant in congenital adrenal hyperplasia (CAH) reported positive results. Atumelnant administration was shown to result in rapid, substantial and sustained statistically significant reduction in androstenedione (A4) levels, the key biomarker for disease control. Atumelnant was well-tolerated and demonstrated significant clinical improvements. We have also initiated an open-label extension study.
Phase 3 CALM-CAH study is designed with an uncompromising primary endpoint to demonstrate atumelnant’s potential ability to normalize androstenedione (A4) levels with physiological glucocorticoid (GC) replacement.
IND clearance for CRN09682, the first candidate from the nonpeptide drug conjugate (NDC) platform. A "Study May Proceed" letter has been received to allow us to begin a Phase 1/2 dose escalation study of CRN09682 with an expansion phase for the treatment of metastatic or locally advanced SST2-positive neuroendocrine tumors and other SST2-expressing solid tumors.
Key Upcoming Milestones
FDA PDUFA target action date of September 25, 2025 for paltusotine NDA for the treatment and maintenance therapy of acromegaly.
R&D Day scheduled for June 26, 2025, where Crinetics will provide updates on its early-stage pipeline, with a focus on CRN09682 for neuroendocrine tumors and other SST2+ tumors, TSH antagonist for Graves’ disease and thyroid eye disease, and SST3 agonist for autosomal dominant polycystic kidney disease.
Crinetics expects to initiate the CAREFNDR Phase 3 trial of paltusotine in carcinoid syndrome in the second half of 2025.
Crinetics expects to initiate the CALM-CAH Phase 3 study in adults with CAH and the Phase 2/3 study in pediatrics in the second half of 2025.
Planning, including regulatory interactions, for the next study of atumelnant in ACTH-dependent Cushing’s syndrome is underway. Initiation of the Phase 2/3 study is expected to begin in the second half of 2025.
IND-enabling activities for the TSH antagonist continue as expected, and the SST3 agonist development is ongoing.
Based on emerging data from IND-enabling studies, our PTH antagonist candidate in preclinical development has been substituted with another candidate expected to exhibit an improved profile. This new candidate is in IND-enabling studies, which we intend to complete next year.
First Quarter 2025 Financial Results
Revenues were $0.4 million for the quarter ended March 31, 2025, compared to $0.6 million for the same period in 2024. Revenues were primarily derived from the paltusotine licensing agreement with Sanwa Kagaku Kenkyusho Co., Ltd.
Research and development expenses were $76.2 million for the three months ended March 31, 2025, compared to $53.3 million for the same period in 2024. The increases were primarily attributable to an increase in personnel costs of $13.3 million, increased manufacturing activities costs of $2.5 million, and increased outside services costs of $4.1 million, for the quarter ended March 31, 2025, respectively, all of which were driven by the advancement of our clinical programs and the expansion of our preclinical portfolio.
Selling, general and administrative expenses were $35.5 million for the three months ended March 31, 2025, compared to $20.8 million for the same period in 2024. The increases were primarily driven by an increase in personnel costs of $7.8 million and an increase in outside services costs of $5.6 million for the quarter ended March 31, 2025, respectively, to support the continued overall growth of the Company and the planned commercial launch of paltusotine.
Net loss for the three months ended March 31, 2025, was $96.8 million, compared to a net loss of $66.9 million for the same period in 2024.
Cash, cash equivalents, and investments totaled $1.3 billion as of March 31, 2025, compared to $1.4 billion as of December 31, 2024. Based on current projections, Crinetics expects that its cash, cash equivalents and investments will be sufficient to fund its current operating plan into 2029. For 2025, we continue to anticipate our cash used in operations to be between $340 and $380 million.
Conference Call and Webcast Details
Management will hold a live conference call and webcast today, Thursday, May 8 at 4:30 p.m. ET. To participate, please dial 1-800-267-6316 (domestic) or 1-203-518-9783 (international) and refer to Conference ID CRNXQ4. To access the webcast, the direct link (here) or visit the Events page of the Crinetics website. Following the live event, the webcast will be archived on the Investor Relations section of www.crinetics.com.

On May 8, 2025 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 and infectious diseases, reported updates on preclinical immune response data with a novel, investigational Infectimune based flu vaccine that were featured at the American Association of Immunologists’ IMMUNOLOGY2025 Annual Meeting, which took place May 3-7, 2025, in Honolulu, Hawaii (Press release, PDS Biotechnology, MAY 8, 2025, View Source [SID1234652756]).

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As previously announced, on Sunday, May 4, 2025, Andrea Sant, Ph.D., Professor of Microbiology and Immunology at the University of Rochester Medical Center, presented "How immune memory from influenza infection shapes protective immune responses to vaccination," during the International Society of Influenza and Other Respiratory Viruses (ISIRIV) sponsored symposium. The discussion described how, in preclinical influenza studies, the use of Infectimune resulted in the elicitation of a significantly greater frequency of highly multifunctional, influenza-specific CD4 T cells that produced multiple cytokines compared to current vaccine approaches and also exhibited cytotoxic (cell killing) characteristics. Infectimune was uniquely able to promote CD4 T cells that targeted lung tissue in those with a history of influenza infection.

Separately, on Tuesday May 6, 2025, James D. Allen, Ph.D., Program Director/Research Associate, Florida Research and Innovation Center, Cleveland Clinic, presented preclinical data in a poster (#2219) titled, "H3 Hemagglutinin proteins optimized for 2018-2022 elicit protective antibodies across panels of modern influenza A (H3N2) viruses." In preclinical ferret studies, Infectimune based universal flu vaccines, comprised of PDS Biotech-licensed computationally optimized broadly reactive antigens (COBRAs), neutralized and protected against historical H3N2 influenza strains that occurred between 2014 and 2021, demonstrating excellent breadth of protective immune response against multiple strains of influenza.

"With increasing recent interest in universal vaccines as the next frontier in influenza vaccine development, we are pleased to see continued interest from leading experts in the potential of Infectimune as a promising option," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "This collaborative approach allows PDS Biotech to focus our resources on our immuno-oncology programs, particularly our VERSATILE-003 Phase 3 clinical trial evaluating Versamune HPV in recurrent/metastatic HPV16-positive head and neck squamous carcinoma ("HNSCC")."