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")."

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 8, 2025 Novavax, Inc. (Nasdaq: NVAX) reported its financial results and operational highlights for the first quarter ended March 31, 2025 (Press release, Novavax, MAY 8, 2025, View Source [SID1234652754]).

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"I am pleased with the progress we have made in the first quarter on our corporate growth strategy," said John C. Jacobs, President and Chief Executive Officer, Novavax. "We remain focused on creating shareholder value as we advance our three priorities for the year – optimizing our partnership with Sanofi, advancing new and existing partnership opportunities and continuing the development of our early-stage organic pipeline."

First Quarter 2025 and Recent Highlights

Strategic Priority #1: Sanofi Partnership

•COVID-19 Biologics License Application (BLA) under review by the U.S. Food and Drug Administration (FDA). In April 2025, we received an information request for a postmarketing commitment (PMC) for a clinical trial. Discussions with the FDA regarding our proposed study design are ongoing and we believe our BLA is approvable upon alignment on the details of the PMC.

oAchievement of BLA approval triggers a $175 million milestone payment from Sanofi.
•Transfers of marketing authorization to Sanofi for U.S. and European Union (EU) markets, assuming approvals in each jurisdiction, are expected in Q4 2025 and trigger an additional $50 million in combined milestones from Sanofi.

Strategic Priority #2: Leverage our technology platform and pipeline to forge additional partnerships

•In April 2025, Novavax and Takeda Pharmaceuticals announced significantly improved terms for their partnership to support ongoing commercialization of Nuvaxovid in Japan. As part of this agreement, Novavax will receive a $20 million upfront payment, a payment related to the 2024-2025 season and is eligible to receive annual milestone payments plus royalties on net sales.
•In March 2025, Novavax signed an additional Material Transfer Agreement (MTA) for Matrix-M with a top tier pharmaceutical company, expanded the scope of the MTA signed in the fall to now include viral pathogens, and entered a preclinical collaboration with a new partner to explore the application and utility of Matrix-M with their cancer vaccine candidate.
•Completed enrollment and expect initial cohort data by mid-year for the Phase 3 trial for our COVID-19-Influenza Combination (CIC) and stand-alone seasonal influenza vaccine candidates to evaluate immunogenicity and safety in adults aged 65 and older. Novavax intends to partner these programs, and this trial reflects the material completion of investment by Novavax.
•Presented data at the April 2025 World Vaccine Congress on the potential of Novavax’s technology platform and Matrix-M adjuvant, which showcases attributes related to efficacy and tolerability. Highlights included utility of Matrix-M across multiple vaccine platforms and disease areas, underscoring breadth of potential partnership opportunities.

Strategic Priority #3: Advance our technology platform and early-stage pipeline

•In April 2025, announced preliminary results from the SHIELD-Utah study that showed Novavax’s COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) targeting the JN.1 strain resulted in fewer and less severe reactogenicity symptoms, when compared with the Pfizer-BioNTech mRNA 2024-2025 vaccine.
•Continued advancement of early-stage preclinical research for H5N1 avian pandemic influenza, respiratory syncytial virus combinations, varicella-zoster virus (shingles) and Clostridioides difficile colitis vaccine candidates.
•Continued work on new potential Matrix formulations intended to improve upon and expand the utility of Matrix-M.

On May 8, 2025 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the first quarter ended March 31, 2025 (Press release, Nektar Therapeutics, MAY 8, 2025, View Source [SID1234652753]).

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Cash and investments in marketable securities on March 31, 2025 were $220.7 million as compared to $269.1 million on December 31, 2024. Nektar’s cash and marketable securities are expected to support strategic development activities and operations into the fourth quarter of 2026.

"We are on track to report topline data in June from the Phase 2 study of rezpegaldesleukin in atopic dermatitis," said Howard W. Robin, President and CEO of Nektar. "These data will be followed by the topline data from the Phase 2 study of rezpegaldesleukin in patients with alopecia areata in December of this year. The results of both randomized studies will demonstrate the potential of rezpegaldesleukin to provide a new treatment paradigm for patients with these serious dermatological diseases. As a first-in-class T regulatory cell biologic, rezpegaldesleukin is poised to emerge as an important novel mechanism to treat millions of patients with chronic autoimmune disorders."

"We are also on track to complete our IND-enabling work for NKTR-0165, our unique antibody targeting the TNFR2 receptor, that has the potential to be developed as a treatment for multiple sclerosis, ulcerative colitis and vitiligo," continued Robin. "We are targeting the submission of the IND for NKTR-0165 at the end of this year. Additionally, we are making significant progress on our new bispecific antibody, NKTR-0166. This antibody incorporates a TNFR2 epitope with a validated antibody target and is advancing into preclinical studies."

Summary of Financial Results

Revenue in the first quarter of 2025 was $10.5 million as compared to $21.6 million in the first quarter of 2024. Revenue has decreased year over year because we no longer recognize product sales due to the sale of the Huntsville manufacturing facility in December 2024.

Total operating costs and expenses in the first quarter of 2025 were $55.0 million as compared to $57.1 million in the first quarter of 2024. Operating costs and expenses for the first quarter of 2025 decreased as compared to 2024 due to the elimination of cost of goods sold following the sale of the Huntsville manufacturing facility, partially offset by increases in R&D and G&A expenses.

R&D expense in the first quarter of 2025 was $30.5 million as compared to $27.4 million for the first quarter of 2024. R&D expense increased primarily due to an increase in expense for the development of rezpegaldesleukin, partially offset by a decrease in expense for the development of NKTR-255.

G&A expense was $24.3 million in the first quarter of 2025 and $20.1 million in the first quarter of 2024. G&A expense increased due to an increase in legal expenses, partially offset by decreases in facilities and stock-based compensation expenses.

In the first quarter of 2025, we began accounting for our investment in the new portfolio company, Gannet BioChem, under the equity method of accounting which calculates our gain or loss based on the change in our share of Gannet BioChem’s equity each quarter. This resulted in a $4.5 million non-cash loss from the equity method investment.

Net loss for the first quarter of 2025 was $50.9 million or $0.24 basic and diluted loss per share as compared to a net loss of $36.8 million or $0.19 basic and diluted loss per share in the first quarter of 2024. Excluding the $4.5 million non-cash loss from our equity method investment in Gannet BioChem, net loss, on a non-GAAP basis, for the first quarter of 2025 was $46.4 million or $0.22 basic and diluted loss per share.

Recent Business Highlights

● In April 2025, the European Hematological Association (EHA) (Free EHA Whitepaper) selected the abstract submitted by Nektar collaborators at the Fred Hutchinson Cancer Center entitled "Enhanced CAR T-cell Expansion and Durable Complete Responses with NKTR-255 Plus Lisocabtagene Maraleucel in Relapsed/Refractory Large B-cell Lymphoma" for oral presentation at the 30th annual EHA (Free EHA Whitepaper) Congress, being held in Milan, Italy from June 12-15, 2025.

● In February 2025, Nektar announced completion of target enrollment in the REZOLVE-AA 84-patient Phase 2b clinical trial of rezpegaldesleukin in severe-to-very severe alopecia areata.

● In February 2025, Nektar announced a new clinical trial agreement with TrialNet, an international clinical trial network at the forefront of diabetes research, to evaluate rezpegaldesleukin in a Phase 2 study of approximately 70 patients with new onset type 1 diabetes mellitus.

● In February 2025, the FDA granted Fast Track designation for rezpegaldesleukin for the treatment of adult and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

● In January 2025, Nektar announced completion of target enrollment in the REZOLVE-AD 396-patient Phase 2b clinical trial of rezpegaldesleukin in moderate-to-severe atopic dermatitis.

Conference Call to Discuss First Quarter 2025 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time on May 8, 2025.

This press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through June 8, 2025.

To access the conference call, please pre-register at Nektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call.