Soligenix Announces Recent Accomplishments And First Quarter 2025 Financial Results

On May 9, 2025 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended March 31, 2025 (Press release, Soligenix, MAY 9, 2025, View Source [SID1234652827]).

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"Our strategic focus remains on advancing our clinical programs, and we anticipate several significant development milestones. These include top-line results in 2026 from our actively enrolling Phase 3 confirmatory study of HyBryte (synthetic hypericin) for early-stage cutaneous T-cell lymphoma (CTCL). Furthermore, we expect to report top-line results in the second half of this year from our ongoing Phase 2 studies of SGX945 (dusquetide) in Behçet’s disease and SGX302 (synthetic hypericin) in mild-to-moderate psoriasis," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.

Dr. Schaber continued, "With approximately $7.3 million in cash at March 31, 2025, we are committed to allocating resources responsibly to achieve our strategic goals and near-term milestones. While this cash balance provides sufficient operating runway through December 2025, we continue to evaluate all strategic options, including partnership, merger and acquisition, government grants, and potential financing opportunities to advance our late-stage pipeline and the Company."

Soligenix Recent Accomplishments

On April 14, 2025, the Company announced positive interim results following 18 weeks of treatment from the ongoing open-label, investigator-initiated study (IIS) evaluating extended HyBryte treatment for up to 54 weeks in patients with early-stage CTCL. To view this press release, please click here.
On March 25, 2025, the Company announced a publication describing the preclinical efficacy of CiVax, a thermostabilized subunit vaccine against SARS-CoV-2. To view the publication, please click here. To view this press release, please click here.
Financial Results – Quarter Ended March 31, 2025

Soligenix reported no revenue for the quarter ended March 31, 2025, compared to $0.1 million for the prior quarter ended March 31, 2024. The decrease was primarily related to a decrease in revenue associated with the zero-margin grant for the HyBryte IIS.

Soligenix’s net loss was $3.2 million, or ($1.06) per share, for the quarter ended March 31, 2025, compared to $1.9 million, or ($2.91) per share, for the quarter ended March 31, 2024. This increase in net loss was primarily due to an increase in operating expenses related to ongoing clinical trials and a decrease in other income attributable to the change in the fair value of debt during the three months ended March 31, 2024 with no corresponding change in fair value during the three months ended March 31, 2025.

Research and development expenses were $2.2 million for the quarter ended March 31, 2025 as compared to $1.1 million for the same period in 2024. The increase was primarily due to costs associated with our Phase 2 study in Behçet’s Disease and the second confirmatory Phase 3 CTCL trial as well as increases in third party manufacturing.

General and administrative expenses were $1.1 million for the quarter ended March 31, 2025 as compared to $1.0 million for the same period in 2024. The increase was primarily attributable to increases in professional expenses and various taxes.

As of March 31, 2025, the Company’s cash position was approximately $7.3 million.

Protalix BioTherapeutics Reports First Quarter 2025 Financial and Business Results

On May 9, 2025 Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported financial results for the quarter ended March 31, 2025, and provided a business and clinical update (Press release, Protalix, MAY 9, 2025, View Source [SID1234652826]).

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"We had another solid quarter, with an increase in revenues from selling goods compared to the prior year quarter," said Dror Bashan, Protalix’s President and Chief Executive Officer. "Given the promising results obtained in 2024 from our first-in-human study of our gout candidate, PRX-115, we are focused on building on the momentum and working toward initiating a phase II clinical trial in patients with gout later this year. At the same time, we continued to evaluate additional pipeline candidates for potential further development, including PRX-119 as well as various early-stage clinical assets."

First Quarter 2025 and Recent Business and Clinical Highlights

Pipeline Developments

PRX-115

●In 2024, we successfully completed the First-in-Human (FIH) phase I clinical trial of PRX-115, our recombinant PEGylated uricase product candidate in development as a potential treatment for uncontrolled gout. The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD; reduction of uric acid) following a single dose of PRX-115 in subjects with elevated uric acid levels. We are in the advance stages of preparations for the phase II clinical trial we expect to commence during the second half of 2025.
oThe preliminary results of the FIH study demonstrate that PRX-115 has the potential to offer an effective uric acid-lowering treatment with an added benefit of a potentially wide dosing interval, which may enhance patient compliance and treatment flexibility. Further studies are needed to confirm the long-term safety and efficacy of PRX-115 in the gout patient population.
oThe results were presented in a late-breaking poster at the American College of Rheumatology (ACR) Convergence 2024, being held November 14-19, 2024 at the Walter E. Washington Convention Center in Washington, D.C. A copy of the poster is available on the Protalix website here: View Source
Pegunigalsidase alfa

●In March 2025, our global development and commercial partner, Chiesi Global Rare Diseases, announced multiple presentations on pegunigalsidase alfa and Fabry Disease at the 21st Annual WORLDSymposium Research Meeting. The Poster presentations are available in the publications section of Protalix’s website.
First Quarter 2025 Financial Highlights

●We recorded revenues from selling goods of $10.0 million during the three months ended March 31, 2025, an increase of $6.3 million, or 170%, compared to revenues of $3.7 million for the three months ended March 31, 2024. The increase resulted primarily from an increase of $5.9 million in sales to Pfizer Inc. and an increase of $0.4 million in sales to Fundação Oswaldo Cruz, or Fiocruz (Brazil).
●We recorded revenues from license and R&D services of $0.1 million for the three months ended March 31, 2025 and the three months ended March 31, 2024. Revenues from license and R&D services are comprised primarily of revenues we recognized in connection with our license and supply agreements with Chiesi. We expect to generate minimal revenues from license and R&D services other than potential regulatory milestone payments.
●Cost of goods sold was $8.2 million for the three months ended March 31, 2025, an increase of $5.6 million, or 215%, from cost of goods sold of $2.6 million for the three months ended March 31, 2024. The increase in cost of goods sold resulted primarily from an increase in sales to Pfizer and Fiocruz (Brazil).
●For the three months ended March 31, 2025, our total research and development expenses were approximately $3.5 million comprised of approximately $1.8 million of salary and related expenses, approximately $0.8 million in subcontractor-related expenses, approximately $0.2 million of materials-related expenses and approximately $0.7 million of other expenses. For the three months ended March 31, 2024, our total research and development expenses were approximately $2.9 million comprised of approximately $1.5 million of salary and related expenses, approximately $0.5 million of subcontractor-related expenses, approximately $0.2 million of materials-related expenses and approximately $0.7 million of other expenses. Total increase in research and developments expenses for the three months ended March 31, 2025 was $0.6 million, or 21%, compared to the three months ended March 31, 2024. The increase in research and development expenses resulted primarily from the advance in our clinical pipeline.
●Selling, general and administrative expenses were $2.6 million for the three months ended March 31, 2025, a decrease of $0.5 million, or 16%, compared to $3.1 million for the three months ended March 31, 2024. The decrease resulted primarily from a decrease of $0.4 million in salary and related expenses and a decrease of $0.1 million in selling expenses.
●Financial income, net was $0.4 million for the three months ended March 31, 2025, compared to financial income, net of $0.1 million for the three months ended March 31, 2024. The difference resulted primarily from lower notes interest expenses due to the September
2024 repayment in full of all the outstanding principal and interest payable under our then outstanding 7.50% Senior Secured Convertible Promissory Notes, partially offset by lower interest income on bank deposits and higher exchange rate costs.
●For the three months ended each of March 31, 2025 and March 31, 2024, we recorded a tax benefit of approximately $(0.1) million. The tax benefit resulted primarily from deferred taxes on income mainly derived from GILTI income mainly in respect of Section 174 of the U.S. Tax Cuts and Jobs Act of 2017, or the TCJA. Effective in 2022, Section 174 of the TCJA requires all U.S. companies, for tax purposes, to capitalize and subsequently amortize R&D expenses that fall within the scope of Section 174 over five years for research activities conducted in the United States and over 15 years for research activities conducted outside of the United States rather than deducting such costs in the current year.
●Cash, cash equivalents and short term bank deposits were approximately $34.7 million at March 31, 2025.
●Net loss for the quarter ended March 31, 2025 was approximately $3.6 million, or $0.05 per share, basic and diluted, compared to $4.6 million, or $0.06 per share, basic and diluted, for the same period in 2024.
Conference Call and Webcast Information

We will host a conference call today, May 9, 2025 at 8:30 am EDT, to review the financial results and provide a business update. To participate in the conference call, please dial the following numbers prior to the start of the call:

Conference Call Details:

Date:Friday, May 9, 2025

Time:8:30 a.m. Eastern Daylight Time (EDT)

Toll Free:1-877-423-9813

International:1-201-689-8573

Israeli Toll Free:1-809-406-247

Conference ID:13753682

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Webcast Details:

The conference will be webcast live from the Protalix website and will be available via the following links:

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Conference ID: 13753682

PMV Pharmaceuticals Reports First Quarter 2025 Financial Results and Corporate Highlights

On May 9, 2025 PMV Pharmaceuticals, Inc. ("PMV Pharma" or the "Company"; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, reported financial results for the first quarter ended March 31, 2025, and provided a corporate update (Press release, PMV Pharma, MAY 9, 2025, View Source [SID1234652825]).

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PMV Pharma plans to provide interim analysis data from the Phase 2 PYNNACLE trial in the middle of 2025. This interim analysis will include data for approximately 50 patients, of which approximately 40% are in the ovarian cancer cohort, who have been followed for at least 18 weeks.

"Our registrational PYNNACLE trial continues to progress well and enrollment remains on track," said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. "I am very appreciative of the efforts of our team and their continued execution. We look forward to providing data from the interim analysis in the middle of this year."

Corporate Highlights


Paper published in Cancer Discovery describing the discovery of rezatapopt. The paper entitled, "Restoration of the Tumor Suppressor Function of Y220C-Mutant p53 by Rezatapopt, a Small Molecule Reactivator," can be accessed here.

First Quarter 2025 Financial Results

PMV Pharma ended the first quarter with $165.8 million in cash, cash equivalents, and marketable securities, compared to $183.3 million as of December 31, 2024. Net cash used in operations was $18.3 million for the three months ended March 31, 2025, compared to $16.2 million for the three months ended March 31, 2024.


Net loss for the quarter ended March 31, 2025, was $17.5 million compared to $15.3 million for the quarter ended March 31, 2024.


Research and development (R&D) expenses were $17.4 million for the quarter ended March 31, 2025, compared to $13.2 million for the quarter ended March 31, 2024. The increase in R&D expenses was primarily due to external expenses related to the advancement of product candidates, offset by decreased personnel related costs and stock-based compensation.


General and administrative (G&A) expenses were $4.1 million for the quarter ended March 31, 2025, compared to $5.0 million for the quarter ended March 31, 2024. The decrease in G&A expenses was primarily due to reduced headcount and spend for facility and operational expenses.

About Rezatapopt

Rezatapopt (PC14586) is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein, restoring the wild-type tumor-suppressor function. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation.

About the PYNNACLE Clinical Trial

The ongoing Phase 1/2 PYNNACLE clinical trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation. The primary objective of the Phase 1 portion of the trial was to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of rezatapopt when administered orally to patients. Safety, tolerability, pharmacokinetics and effects on biomarkers were also assessed. The Phase 2 portion is a registrational, single arm, expansion basket clinical trial comprising five cohorts (ovarian, lung, breast, and endometrial cancers, and other solid tumors) with the primary objective of evaluating the efficacy of rezatapopt at the RP2D in patients with TP53 Y220C and KRAS wild-type advanced solid tumors. For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750).

Olema Oncology to Participate in Upcoming Investor Conferences

On May 9, 2025 Olema Pharmaceuticals, Inc. ("Olema", "Olema Oncology", Nasdaq: OLMA) a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported that the Company will participate in the following upcoming investor conferences (Press release, Olema Oncology, MAY 9, 2025, View Source [SID1234652824]):

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H.C. Wainwright 3rd Annual BioConnect Investor Conference
Date: Tuesday, May 20, 2025 at 4:30 p.m. ET
Format: Fireside Chat
Location: New York, NY

T.D. Cowen 6th Annual Oncology Innovation Summit: Insights for ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper)
Date: Tuesday, May 27, 2025 at 5 p.m. ET
Format: Fireside Chat
Location: Virtual

Live webcasts and recordings of these presentations will be available, as permitted by the event host, in the Events and Presentations section of Olema’s investor relations website at ir.olema.com.

Lilly plans to expand Purdue University collaboration with up to a $250 million investment to accelerate pharmaceutical innovation

On May 9, 2025 Eli Lilly and Company (NYSE: LLY) and Purdue University reported a significant expansion of their long-standing alliance, with Lilly’s planned investment of up to $250 million in the collaboration over the next eight years (Press release, Eli Lilly, MAY 9, 2025, View Source [SID1234652822]). This partnership, which has the potential to be the largest ever industry-academic agreement of its kind in the United States, will seek to accelerate innovation at every stage of the pharmaceutical pipeline.

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The Lilly-Purdue 360 Initiative aims to achieve several key goals, including discovering and accelerating the delivery of medicines to patients; bridging the gap between laboratory discoveries and clinical applications; creating more resilient, efficient and sustainable supply chains; and deploying innovative, scalable approaches to workforce development. The expanded collaboration is also expected to generate significant economic benefits for Indiana by creating a highly skilled workforce and fostering local innovation.

The earlier agreement, which had been set to expire in 2027, will now extend with four new projects added through 2032. Additionally, it will engage existing joint programs, such as Lilly Scholars at Purdue and the Lilly and Purdue Research Alliance Center (LPRC). Purdue will make space available for Lilly researchers on-site in West Lafayette. Purdue researchers will collaborate in Lilly facilities in Indianapolis and in Indiana’s LEAP Research and Innovation District.

"As potentially the largest single university-industry research agreement in American history, Lilly and Purdue are blazing a new trail to the endless frontier," said Purdue University President Mung Chiang. "As for our state, when its largest company and the largest university expand collaboration at a scale never seen before, especially in the backdrop of Lilly’s manufacturing facility in LEAP, today marks a monumental watershed in the generation of jobs, workforce, and innovation along America’s Hard-Tech Corridor. We thank Lilly for its pioneering impact on health and medicine in our society and for what is now the largest single research funding, from public or private capital, in Purdue’s history."

To achieve the initiative’s ambitious goals, Lilly and Purdue will concentrate on several key areas:

Applying AI-powered tools to augment traditional drug discovery methods while leveraging advancements in machine learning and big data analytics to explore disease mechanisms and personalized treatments
Facilitating technology-enabled approaches to accelerate potential treatments from Phase I clinical studies to regulatory approval and technology transfer into manufacturing — critical focus areas of the Lilly Medicine Foundry
Incorporating robotics, AI, and data sciences to quickly scale manufacturing capacity more effectively, with improved compliance and greater sustainability
Enhancing workforce development to ensure a strong talent pipeline to meet the demands of Lilly and other Indiana employers
"Accelerating the delivery of life-changing medicines demands a highly skilled workforce and continuous innovation across discovery, process development and manufacturing," said David A. Ricks, Lilly’s chair and CEO. "Through this expanded collaboration with Purdue, we look forward to combining our strengths in advanced technologies and cutting-edge science to pioneer new methods of delivering next-generation medicines to advance human health."

The Lilly-Purdue 360 Initiative supports Purdue’s One Health initiative, which advances knowledge and innovation related to animal, human, and plant well-being through novel interdisciplinary initiatives and partnerships with industry.