On May 9, 2025 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor, reported financial results and provided an update on recent operational highlights for the first quarter ended March 31, 2025 (Press release, Allarity Therapeutics, MAY 9, 2025, View Source [SID1234652829]).

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"The start of 2025 marks an important next chapter for Allarity," said Thomas Jensen, CEO of Allarity Therapeutics. "With enrollment about to begin in both our self-funded ovarian cancer trial and the Veterans Administration–funded combination trial in small cell lung cancer, we are focused on generating the data needed to advance stenoparib toward regulatory approval. The continued durability of response observed in ovarian cancer patients is encouraging, and we look forward to sharing updates on both trials in the months ahead."

Clinical and Drug Development Progress

Durable Clinical Benefit as monotherapy dosed twice daily: Multiple patients treated with stenoparib in the ongoing Phase 2 trial for advanced ovarian cancer exceeded 30 weeks on therapy, with two patients still on treatment and receiving benefit more than 19 months, underscoring the drug’s safety profile.
DRP Platform Expansion Beyond Small Molecules: At AACR (Free AACR Whitepaper) 2025, Allarity presented a novel DRP for daratumumab in multiple myeloma, marking the Company’s first DRP developed for a targeted antibody therapy. This milestone expands the versatility of the DRP platform, which was previously focused exclusively on small-molecule drugs.
New Protocol Implemented: Building on compelling data in the ongoing phase 2 ovarian cancer trial, the Company implemented a new Phase 2 protocol focused on platinum-resistant, advanced ovarian cancer patients, with the goal of optimizing dose and refining patient selection to accelerate stenoparib more aggressively toward regulatory approval.
Combination Trial Launched: Allarity announced a new Phase 2 trial evaluating stenoparib in combination with temozolomide for recurrent small cell lung cancer (SCLC), fully funded by the U.S. Veterans Administration. Allarity’s material contribution is limited to supplying the necessary stenoparib drug product. This novel trial is based upon compelling therapeutic rationale for the combination and could provide a new treatment option for these patients whose options are otherwise limited.
Clinical Data Presented at SGO: The Company presented updated Phase 2 clinical data at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting, demonstrating durable clinical benefit from stenoparib in heavily pre-treated ovarian cancer patients, including those with platinum-resistant, platinum-refractory, and BRCA wild-type disease.
Financial Strengthening and Corporate Development

Fully utilized the Company’s At-the-Market (ATM) offering program initiated in March 2024. With all capacity under the related Form S-3 now exhausted, the current ATM program has concluded.
Authorized a $5 million share repurchase program, reinforcing confidence in long-term shareholder value​.
To date, the Company has repurchased approximately 2 million shares under the authorized buyback program.
Initiated efforts to combat potential illegal short selling, engaging ShareIntel to investigate trading irregularities through enhanced market surveillance and potential legal action.
Ended Q1 2025 with a cash and restricted cash balance of approximately $27 million, further reinforcing the Company’s financial stability and ability to execute on clinical development objectives.
Regulatory and Compliance Resolutions

Finalized settlement with the SEC following receipt of a Wells Notice in July 2024, resolving all outstanding regulatory matters related to past disclosures by prior management regarding FDA interactions on the Dovitinib NDA, which was submitted to the FDA in 2021.
Had class action lawsuit dismissed, closing all related shareholder litigation and further clearing the path for Allarity to focus on clinical and corporate progress.
Anticipated Clinical Milestones in 2025

New Ovarian Cancer Trial Protocol—New Protocol Enrollment: In the first half of 2025, Allarity expects to begin enrollment under a new protocol for stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer. The updated protocol design reflects the compelling, durable clinical benefit observed to date in platinum resistant patients. The protocol aims to provide the definitive foundation for pivotal registration trials for stenoparib in ovarian cancer.​
New Small Cell Lung Cancer Trial—Combination Study: Patient enrollment will initiate in Q2-Q3 2025 in this new Phase 2 trial evaluating stenoparib in combination with temozolomide for recurrent small cell lung cancer (SCLC). The trial, fully funded by the U.S. Veterans Administration, will assess the potential of this novel combination to improve outcomes in recurrent SCLC patients with extremely limited therapeutic opportunities.
First Quarter 2025 Operating Results

Cash Position: As of March 31, 2025, cash, cash equivalents and restricted cash totaled $27.7 million compared to $20.9 million of cash and cash receivables at December 31, 2024.
R&D Expenses: Research and Development (R&D) expenses for the quarter ended March 31, 2025, were $1.4 million, compared to $2.2 million for the quarter ended March 31, 2024.
G&A Expenses: General and Administrative (G&A) expenses for the quarter ended March 31, 2025, were $1.6 million, compared to $2.1 million for the quarter ended March 31, 2024.
Net Loss: Net loss was $2.7 million for the quarter ended March 31, 2025, compared to $3.8 million for the quarter ended March 31, 2024.
About Stenoparib
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant Wnt/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug-specific DRP to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature.

On May 9, 2025 Turnstone Biologics Corp. ("Turnstone" or the "Company") (Nasdaq-CM: TSBX), a biotechnology company historically focused on the development of a differentiated approach to treat and cure patients with solid tumors by pioneering selected tumor-infiltrating lymphocyte ("Selected TIL") therapy, reported financial results for the first quarter ended March 31, 2025, and provided recent corporate updates (Press release, Turnstone Biologics, MAY 9, 2025, View Source [SID1234652828]).

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Corporate Updates

In January 2025, Turnstone made the determination to discontinue all TIDAL-01 clinical studies and halted further development of the program. As a result, the Company initiated a process to explore a range of potential strategic alternatives focused on maximizing shareholder value. Turnstone continues to evaluate strategic alternatives and will provide additional updates when it is determined that further disclosure is appropriate or legally required.

In March 2025, Turnstone received approval from the Listing Qualifications Department at the Nasdaq Stock Market ("Nasdaq") to transfer listing of its shares from the Nasdaq Global Market to the Nasdaq Capital Market. This transfer was effective as of the opening of business on March 31, 2025, and the Company’s shares of Common Stock continue to trade under the "TSBX" ticker symbol. The approval by Nasdaq was conditioned upon the Company meeting the applicable market value requirement of publicly held shares for continued listing and all other applicable requirements for listing on the Nasdaq Capital Market.

Financial Highlights

Cash, Cash Equivalents and Short-Term Investments: As of March 31, 2025, cash, cash equivalents and short-term investments were $21.9 million.

Research and Development (R&D) Expenses: R&D expenses for the three months ended March 31, 2025, were $4.4 million, compared to $15.8 million for the same period in 2024. The decrease was due primarily to shutting down almost all clinical development activities and the pursuit of strategic alternatives.

General and Administrative (G&A) Expenses: G&A expenses for the three months ended March 31, 2025, were $4.8 million, compared to $4.9 million for the same period in 2024.

Net Loss: Net loss for the three months ended March 31, 2025, was $11.8 million, compared to net loss of $19.6 million for the same period in 2024.

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.

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

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

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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.

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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.

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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.

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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).