On May 8, 2025 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the first quarter ended March 31, 2025 (Press release, Puma Biotechnology, MAY 8, 2025, View Source [SID1234652760]). Unless otherwise stated, all comparisons are for the first quarter of 2025 compared to the first quarter of 2024.

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Product revenue, net consists entirely of revenue from sales of NERLYNX, Puma’s first commercial product. Product revenue, net in the first quarter of 2025 was $43.1 million, compared to product revenue, net of $40.3 million in the first quarter of 2024.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $3.0 million, or $0.06 per basic and diluted share, for the first quarter of 2025, compared to net loss of $4.8 million, or $0.10 per basic and diluted share, for the first quarter of 2024.

Non-GAAP adjusted net income was $5.0 million, or $0.10 per basic and diluted share, for the first quarter of 2025, compared to non-GAAP adjusted net loss of $2.4 million, or $0.05 per basic share and diluted share, for the first quarter of 2024. Non-GAAP adjusted net income (loss) excludes stock-based compensation expense. For a reconciliation of GAAP net income (loss) to non-GAAP adjusted net income (loss) and GAAP net income (loss) per share to non-GAAP adjusted net income (loss) per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the first quarter of 2025 was $3.6 million, compared to $11.3 million provided by operating activities in the first quarter of 2024. At March 31, 2025, Puma had cash, cash equivalents and marketable securities of $93.2 million, compared to cash, cash equivalents and marketable securities of $101.0 million at December 31, 2024.

"We are pleased to report better than expected net income for the first quarter of 2025," said Alan H. Auerbach, Chairman, Chief Executive Officer, and President of Puma. "We recently presented new clinical data on neratinib at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 and we look forward to important updates from our ongoing alisertib clinical studies later this year."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) presentation of interim data from ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (H2 2025); and (ii) presentation of additional interim data from the ALI-4201/ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (H2 2025)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX and royalty revenue. For the first quarter ended March 31, 2025, total revenue was $46.0 million, of which $43.1 million was net product revenue and $2.9 million was royalty revenue. This compares to total revenue of $43.8 million in the first quarter of 2024, of which $40.3 million was net product revenue and $3.5 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $42.0 million for the first quarter of 2025, compared to $46.1 million for the first quarter of 2024.

Cost of Sales

Cost of sales was $10.6 million for the first quarter of 2025, virtually unchanged from $10.7 million for the first quarter of 2024.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $17.6 million for the first quarter of 2025, compared to $21.8 million for the first quarter of 2024. The $4.2 million decrease resulted primarily from a decrease of $3.6 million in professional fees and expenses, primarily legal fees; a decrease of $0.2 million in payroll and related costs; and a decrease of $0.2 million in stock-based compensation.

Research and Development Expenses

Research and development expenses were $13.8 million for the first quarter of 2025, compared to $13.6 million for the first quarter of 2024. The $0.2 million increase resulted primarily from increases of $0.2 million in clinical trial expenses; and $0.2 million in consultants and contractors; partially offset by a decrease of $0.1 million in stock-based compensation.

Total Other Income (Expenses)

Total other expenses were $0.7 million for the first quarter of 2025, compared to total other expenses of $2.3 million for the first quarter of 2024. The $1.6 million decrease resulted primarily from a lower debt balance, which reflects principal payments of approximately $11.1 million per quarter.

Second Quarter and Full Year 2025 Financial Outlook

Second Quarter 2025

Full Year 2025 (current)

Full Year 2025 (previous)

Net Product Revenue

$48–$50 million

$192–$198 million

$192–$198 million

Royalty Revenue

$2–$3 million

$20–$24 million

$20–$24 million

License Revenue

$0 million

$0 million

$0 million

Net Income/(Loss)*

$4–$6 million

$23–$28 million

$23–$28 million

Gross to Net Adjustment

20%–21.5%

20.5%–21.5%

20.5%–21.5%

*The outlook above does not include any adjustments for tax valuation allowance.

Conference Call

Puma Biotechnology will host a conference call to report its first quarter 2025 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PT/4:30 p.m. ET on Thursday, May 8, 2025. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.

On May 8, 2025 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported financial results for the first quarter ended March 31, 2025, and provided a business update (Press release, Protara Therapeutics, MAY 8, 2025, View Source [SID1234652759]).

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"We have made significant progress thus far in 2025, notably with the recent presentation of positive interim results from our ADVANCED-2 trial of TARA-002 in BCG-Unresponsive and BCG-Naïve patients which demonstrated durable 12-month landmark responses," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "We believe TARA-002 is well positioned to make a meaningful difference in the lives of patients with non-muscle invasive bladder cancer (NMIBC). In addition to our NMIBC program, we are pleased with the continued progress we have made across our rare disease programs and look forward to several exciting data milestones in the coming months."

Recent Progress and Highlights

TARA-002 in NMIBC

At the American Urological Association (AUA) 2025 Annual Meeting in April, the Company announced positive updated interim results from the ADVANCED-2 trial in evaluable NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-Unresponsive and BCG-Naïve. As of the April 16, 2025 data cutoff:
TARA-002 demonstrated a complete response (CR) rate at any time of 100% (5/5) and 67% (2/3) at 12 months in the cohort of BCG-Unresponsive patients. As previously communicated, the BCG-Unresponsive cohort is designed to be registrational in alignment with the 2024 BCG-Unresponsive Non-muscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment Draft Guidance for Industry issued by the U.S. Food and Drug Administration (FDA).
In the proof-of-concept BCG-Naïve cohort of patients, TARA-002 demonstrated a CR rate at any time of 76% (16/21) and a CR rate of 43% (3/7) at 12 months.
The majority of adverse events were Grade 1 and transient, with no Grade 3 or greater treatment-related adverse events as assessed by study investigators.
Interim results from approximately 25 six-month evaluable BCG-Unresponsive patients are expected to be announced by the end of 2025.
Following regulatory alignment with the FDA, the Company expects to provide an update on the design of its planned BCG-Naïve registrational trial in the second half of 2025.
Protara continues to investigate subcutaneous dosing through priming and maintenance combined with intravesical dosing, as well as exploring combination treatment with TARA-002 in NMIBC patients with CIS.
IV Choline Chloride for Patients on Parenteral Support (PS)

The Company plans to initiate THRIVE-3, a registrational Phase 3 clinical trial, in the third quarter of 2025. THRIVE-3 is a seamless Phase 2b/3 trial with a dose confirmation portion (n=24) followed by a double-blinded, randomized, placebo-controlled portion to assess the efficacy and safety of IV Choline Chloride over 24 weeks in adolescents and adults on long-term PS when oral or enteral nutrition is not possible, insufficient, or contraindicated (n=105). IV Choline Chloride was previously granted Fast Track designation by the FDA.
TARA-002 in LMs

Dosing continues to progress in the Phase 2 STARBORN-1 trial of TARA-002 in pediatric patients with macrocystic and mixed cystic LMs and the Company intends to provide an interim update from the trial in the second half of 2025. The Company previously announced the completion of the study’s first safety cohort, in which TARA-002 showed promising results and was generally well-tolerated.
Corporate Update

In April 2025, Protara strengthened its leadership team with the appointments of Leonardo Viana Nicacio, M.D., as Chief Medical Officer, and Shane Williams, Ph.D., as Vice President, Head of Human Resources, Chief People Officer. Dr. Nicacio brings to Protara nearly 20 years of broad oncology, drug development, regulatory and commercial experience across leading biopharmaceutical and health technology companies, and most recently served as Head of Clinical Development and Global Medical Affairs at Stemline Therapeutics. Dr. Williams brings a strong track record of driving growth, leading transformational change, and building high-performing teams across innovative life science organizations. He most recently served as Chief People Officer at Century Therapeutics.
First Quarter 2025 Financial Results

As of March 31, 2025, unrestricted cash and cash equivalents and investments in marketable debt securities totaled $157.5 million. The Company expects its cash, cash equivalents, and investments in marketable debt securities will be sufficient to fund operations into 2027.
Research and development expenses for the first quarter of 2025 increased to $9.1 million from $7.7 million for the prior year period. The increase was primarily due to a $2.6 million increase in clinical trial activities for TARA-002 and IV Choline, offset by a $1.2 million decrease in indirect expenses.
General and administrative expenses for the first quarter of 2025 increased to $5.0 million from $4.1 million for the prior year period. This increase was primarily due to a $0.4 million increase in personnel-related costs as well as an increase of professional fees of $0.4 million.
For the first quarter of 2025, Protara incurred a net loss of $11.9 million, or $0.29 per share, compared with a net loss of $11.1 million, or $0.97 per share, for the same period in 2024. Net loss for the first quarter of 2025 included approximately $0.8 million of stock-based compensation expenses.
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 Designation by the U.S. Food and Drug Administration. 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. Protara has successfully shown manufacturing comparability between TARA-002 and OK-432.

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 release of cytokines such as tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma IL-6, IL-10, 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.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Bladder cancer is the 6th most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses. Approximately 65,000 patients are diagnosed with NMIBC in the United States 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.

About Lymphatic Malformations (LMs)

LMs are rare, congenital malformations of lymphatic vessels resulting in the failure of these structures to connect or drain into the venous system. Most LMs are present in the head and neck region and are diagnosed in early childhood during the period of active lymphatic growth, with more than 50% 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, lymphatics; recurrent infection, and cosmetic and other functional disabilities.

About IV Choline Chloride

IV Choline Chloride is an investigational, intravenous phospholipid substrate replacement therapy in development for patients receiving parenteral support (PS). Choline is a known important substrate for phospholipids that are critical for healthy liver function that also play an important role in modulating gene expression, cell membrane signaling, brain development and neurotransmission, muscle function, and bone health. PS patients are unable to synthesize choline from enteral nutrition sources, and there are currently no available PS formulations containing choline. Approximately 80% of patients dependent on PS are choline-deficient and of those approximately 63% have some degree of liver dysfunction, which can lead to hepatic failure. Every year in the U.S. there are approximately 90,000 people who require PS at home and of those approximately 30,000 are on long-term PS. IV Choline Chloride has the potential to become the first U.S. Food and Drug Administration (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 PN and 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 us a U.S. patent claiming a choline composition and a U.S. patent claiming a method for treating choline deficiency with a choline composition, each with a term expiring in 2041.

On May 8, 2025 Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, reported financial results for the quarter ended March 31, 2025 and provided a business update (Press release, Prime Medicine, MAY 8, 2025, View Source [SID1234652758]).

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"We recently unveiled our AATD program, further demonstrating our commitment to building a liver franchise of Prime Editors designed to cure major genetic diseases," said Keith Gottesdiener, M.D., President and Chief Executive Officer of Prime Medicine. "Both our Wilson’s Disease and AATD programs are advancing through preclinical development, and we look forward to initiating clinical trials in both indications in 2026. In addition, we remain on track to report initial data from our Phase 1/2 trial of PM359 in CGD this year, and continue to progress our efforts in CF."

Dr. Gottesdiener continued, "While PM359 leverages a different delivery mechanism from our programs in liver and lung diseases, we believe our forthcoming CGD data could provide important readthrough across our pipeline. If positive, these data would demonstrate the potential of Prime Editing as a powerful and differentiated technology, potentially capable of offering curative benefit to patients following a single treatment. We remain committed to executing with focus and discipline as we approach these first in-human data, which we hope will mark a key inflection point on our path to sustained growth."

Prime Medicine’s Pipeline:

Prime Medicine is advancing a set of high-value programs across its core areas of focus (hematology, immunology and oncology, liver, and lung). These include ex vivo hematopoietic stem cell (HSC) programs for the treatment of p47phox chronic granulomatous disease (CGD) and X-linked CGD; lipid nanoparticle (LNP) Prime Editors for the treatment of Wilson’s Disease and alpha-1 antitrypsin deficiency (AATD); LNP or adeno-associated virus (AAV) Prime Editors for the treatment of cystic fibrosis (CF); and ex vivo T-cell therapies, which are being developed in collaboration with Bristol Myers Squibb.

Recent Business Updates

•In March 2025, Prime Medicine unveiled its preclinical program for the treatment of AATD. Prime Medicine’s program leverages the Company’s universal liver LNP to edit the E342K (Pi*Z) mutation in the SERPINA1 gene, the prevalent disease-causing mutation in AATD, with the potential to treat both lung- and liver-associated disease. In initial in vivo data, Prime Medicine observed high levels of editing at the target site, with full restoration of circulating wild-type AAT protein (M-AAT) to normal human range. Additionally, based on preclinical studies using unoptimized surrogate Prime Editors across Prime Medicine’s liver franchise, the Company believes Prime Editing has the ability to correct disease-causing mutations without introducing off-target or bystander edits.
Anticipated Upcoming Milestones:

Chronic Granulomatous Disease (CGD):
•Announce initial clinical data from Cohort 1 in the Phase 1/2 trial of PM359 for p47phox CGD in 2025. The initial readout will include safety and engraftment data, as well as key outcome measures, including the reconstitution of NADPH oxidase activity as measured by the DHR assay.

Wilson’s Disease:
•Advance PM577 through investigational new drug (IND)-enabling studies for the treatment of Wilson’s Disease patients with the most prevalent Wilson’s Disease mutation in the United States.
•File investigational new drug (IND) and/or clinical trial application (CTA) for PM577 in the first half of 2026.
AATD:
•Initiate IND-enabling studies for the treatment of AATD.
•File IND and/or CTA in mid-2026.
First Quarter 2025 Financial Results
•Research and Development (R&D) Expenses: R&D expenses were $40.6 million for the three months ended March 31, 2025, as compared to $37.8 million for the three months ended March 31, 2024. The increase in R&D expenses primarily due to the expansion and build out of our laboratory space at 60 First Street and 500 Arsenal Street.
•General and Administrative (G&A) Expenses: G&A expenses were $13.3 million for the three months ended March 31, 2025, as compared to $11.2 million for the three months ended March 31, 2024. The increase in G&A expenses was driven by personnel expenses.
•Net Loss: Net loss was $51.9 million for the three months ended March 31, 2025, as compared to $45.8 million for the three months ended March 31, 2024.
•Cash Position: As of March 31, 2025, cash, cash equivalents, investments, and restricted cash were $158.3 million, as compared to $204.5 million as of December 31, 2024.
Financial Guidance
Based on its current operating plans, Prime Medicine expects that its cash, cash equivalents and investments as of March 31, 2025 will be sufficient to fund its operating expenses and capital expenditure requirements into the first half of 2026.

On May 8, 2025 Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, reported a corporate update and announced first quarter 2025 financial results (Press release, Pliant Therapeutics, MAY 8, 2025, View Source [SID1234652757]).

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"During the first quarter and over recent weeks, our teams have been working diligently to close out the global BEACON-IPF trial with the goal of announcing topline data in the second quarter," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. "Additionally, progress was made in our oncology program with initial data from our Phase 1 dose escalation trial of PLN-101095 demonstrating antitumor activity, including confirmed partial responses, in a variety of solid tumors."

First Quarter and Recent Developments
Bexotegrast Highlights
•BEACON-IPF close-out activities continue with topline data expected in the second quarter of 2025. Following the termination of the BEACON-IPF Phase 2b/3 trial evaluating bexotegrast in patients with idiopathic pulmonary fibrosis (IPF), the Company continues the formal close out of the global trial. Topline data from the BEACON-IPF trial is expected in the second quarter of 2025.
•Results from a Phase 2a positron emission tomography (PET) imaging trial published in the American Journal of Respiratory and Critical Care Medicine (AJRCCM). The publication reviews the previously reported positive results from the first interventional, single-center double-blind, placebo-controlled Phase 2 trial of bexotegrast using PET and magnetic resonance imaging to evaluate collagen deposition in the lungs of 10 patients with IPF.
Oncology Program
•Interim Phase 1 data from a trial of PLN-101095 and pembrolizumab demonstrated antitumor activity with confirmed partial responses in three of six patients treated with the highest dose tested to date. Topline data from the first three cohorts of the ongoing Phase 1 dose escalation trial of PLN-101095 in combination with pembrolizumab showed confirmed partial responses in solid tumors that are resistant to immune checkpoint inhibitors. Of the six patients treated at the 1000 mg dose administered orally twice daily (BID), three patients, suffering from non-small cell lung cancer (NSCLC), cholangiocarcinoma and melanoma, experienced confirmed partial response assessed by iRECIST criteria associated with 74%, 48% and 42% reductions in tumor size, respectively. PLN-101095 was generally well tolerated across all doses tested. The trial is currently enrolling the fourth of five potential cohorts, evaluating PLN-101095 at 1000 mg administered three times daily (TID).
Corporate Highlights
•Strategic realignment of workforce and operations underway. On May 1, 2025, the Company announced a strategic realignment of its operations including an approximately 45% reduction in its workforce as well as other cost-saving actions. The process is expected to extend the cash runway to support execution of clinical trials, including any late-stage clinical trials, and is expected to be substantially completed by the second quarter of 2025.

First Quarter 2025 Financial Results

•Research and development expenses were $43.4 million, as compared to $37.1 million for the prior-year quarter. The increase was primarily due to acceleration of close-out activities for BEACON-IPF, a Phase 2b/3 study of bexotegrast and employee-related expenses, driven by increased headcount.
•General and administrative expenses were $15.5 million, as compared to $15.2 million for the prior-year quarter. The increase was primarily due to professional service expenses.
•Net loss of $56.2 million as compared to $47.0 million for the prior-year quarter. The increase was primarily due to higher operating expenses driven by close-out activities related to BEACON-IPF.
•As of March 31, 2025, the Company had cash, cash equivalents and short-term investments of $307.1 million.

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")."