On October 15, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported new and updated data from its advancing oncology pipeline will be shared in seven abstracts at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2025 Meeting, taking place from October 17-21 in Berlin, Germany. Highlights include new Phase 3 C-POST data on an every 6-week dosing regimen for the PD-1 inhibitor Libtayo (cemiplimab) as adjuvant treatment for cutaneous squamous cell carcinoma (CSCC) with a high risk of recurrence.

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"Our oncology presentations at ESMO (Free ESMO Whitepaper) represent important progress toward expanding options for people with difficult-to-treat cancers," said Israel Lowy, M.D., Ph.D., Clinical Development Unit Head, Oncology, at Regeneron. "Notably, we look forward to sharing new data on a patient-centric every 6-week dosing option from our C-POST Phase 3 trial, which recently supported the FDA approval of Libtayo as the first immunotherapy for adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation."

The new safety and pharmacokinetic data from C-POST being presented at ESMO (Free ESMO Whitepaper) showcase a patient-centric approach to dosing. Patients received either adjuvant therapy with Libtayo or placebo intravenously, starting with 350 mg every 3 weeks for 12 weeks. The majority of patients were switched to every 6-week dosing after the initial 12 weeks, and the remaining patients continued with dosing every 3 weeks throughout the trial. Treatment continued until disease recurrence, unacceptable toxicity, or up to 48 weeks of treatment. Efficacy, pharmacokinetics and immunogenicity were similar across both regimens. The safety profile of Libtayo as adjuvant treatment of patients with CSCC at high risk of recurrence after surgery and radiation is consistent with the known safety profile for Libtayo monotherapy in advanced cancers.

The full list of Regeneron presentations at ESMO (Free ESMO Whitepaper) includes:

Abstract Title Abstract Presenter Session Date/Time
(CET)
Libtayo skin cancer
Analysis of second primary cutaneous squamous cell carcinoma (CSCC) tumors (SPTs) reported during the C-POST trial, a randomized phase 3 study of adjuvant cemiplimab vs placebo for high-risk CSCC Mini-oral
presentation: 1603MO

Danny
Rischin Saturday,
October 18,
14:45-16:15
Adjuvant cemiplimab for high-risk cutaneous squamous cell carcinoma: Evaluating dosing intervals in a phase 3 trial Poster
presentation:
1660P

Danny
Rischin Monday,
October 20,
12:00-12:45
CemiplimAb-rwlc Survivorship and Epidemiology (CASE): A prospective, non-interventional study of the safety and effectiveness of cemiplimab in immunocompromised/immunosuppressed (IC/IS) patients with advanced cutaneous squamous cell carcinoma (CSCC) at 18 months’ follow-up Poster
presentation:
1666P

Soo J.
Park Monday,
October 20,
12:00-12:45
Libtayo lung cancer
Association between patient-reported outcomes (PROs) and overall survival (OS) in aNSCLC patients treated with first-line (1L) cemiplimab-based therapy Poster
presentation:
1862P

David R.
Gandara Saturday,
October 18,
12:00-12:45
Ubamatamab
Randomized Phase 2 study of ubamatamab ± cemiplimab in patients (pts) with platinum-resistant ovarian cancer (OC) Poster
presentation:
1078P

Jung-Yun
Lee Saturday,
October 18,
12:00-12:45
REGN7075
Mitigating infusion-related reactions (IRRs) with cetirizine and montelukast in patients (pts) receiving REGN7075, an EGFRxCD28 bispecific antibody (bsAb) Poster
presentation:
1558P

Neil H.
Segal Sunday,
October 19,
12:00-12:45
Additional presentations
Predicting real-world overall survival in advanced melanoma using machine learning Poster
presentation: 1632P

Fei
Wang Monday,
October 20,
12:00-12:45

The potential use of ubamatamab described above is investigational, and its safety and efficacy have not been evaluated by any regulatory authority.

(Press release, Regeneron, OCT 15, 2025, View Source [SID1234656677])

On October 15, 2025 Propanc Biopharma, Inc. ("Propanc" or the "Company") reported it has entered into a strategic financing agreement of up to $100 million with Hexstone Capital LLC ("Hexstone"), a family office that has invested in a significant number of Digital Asset Treasury (DAT) companies across a range of digital assets including BTC, ETH, SOL, DOGE, ATH, OG, and INJ. "We are delighted to enter into this strategically important transaction with Hexstone Capital," said James Nathanielsz, Chief Executive Officer of Propanc. "This financing will allow us to accelerate the development of our clinical pipeline and leverage Hexstone’s previous investments in companies that have also built out Digital Asset Treasuries. Our goal is to grow our treasury to a value of $100 million or more within the next twelve months. In less than five years, DAT companies have evolved from being market curiosities to becoming significant players in the digital asset ecosystem. We believe we are well-positioned to capitalize on this trend and generate both short- and long-term value for shareholders."

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Transaction Overview

Under the terms of the agreement, Propanc will issue 100 shares of newly designated Series C Convertible Preferred Stock, each with a par value of $0.01 and an initial stated value of $10,000, resulting in an initial investment of $1 million.

The Preferred Stock is convertible into Common Stock at an initial conversion price of $5.00 per share, representing a 280% premium over the Company’s recent closing price of $1.78. The conversion terms include variable alternative conversion prices and are subject to a 4.99% beneficial ownership limitation, as detailed in the Company’s filings with the U.S. Securities and Exchange Commission (SEC).

Additionally, Propanc will issue 9,900 Warrants to Hexstone, each entitling the purchase of one share of Preferred Stock at $9,999.99, totaling up to $99 million in potential funding. The Warrants are exercisable, immediately, and will remain valid for 12 months. Subject to equity conditions and beneficial ownership limits, the Company may call up to 500 Warrants per calendar month at $0.01 each, allowing up to $5 million in Preferred Stock per month—less any Warrants already exercised by Hexstone during that period.

Further details can be found in the Company’s Form 8-K filed with the SEC and accessible at www.sec.gov.

(Press release, Propanc, OCT 15, 2025, View Source [SID1234656676])

On October 15, 2025 PharmaMar Group (MSE: PHM) reported it has received a milestone payment of $50 million from Jazz Pharmaceuticals plc (Nasdaq:JAZZ) related to the full approval granted on October 2nd of this year from the U.S Food and Drug Administration (FDA) for Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) as a first-line maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.

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In December 2019, PharmaMar entered into an exclusive license agreement with Jazz Pharmaceuticals for lurbinectedin in the United States.

(Press release, PharmaMar, OCT 15, 2025, View Source [SID1234656675])

On October 15, 2025 Keros Therapeutics, Inc. ("Keros" or the "Company") (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta ("TGF-ß") family of proteins, reported that, as part of its previously announced $375 million capital return program, it has entered into share purchase agreements (the "Purchase Agreements") to repurchase all of the shares of the Company’s common stock beneficially owned by each of ADAR1 Capital Management ("ADAR1") and Pontifax Venture Capital ("Pontifax") at a purchase price of $17.75 per share in cash. The aggregate purchase price for the repurchase is approximately $181 million, which is expected to be funded from the Company’s existing cash and cash equivalents. The transactions are expected to close on October 15, 2025. In connection with the Purchase Agreements, Mr. Ran Nussbaum and Mr. Tomer Kariv have tendered their resignations to the Board of Directors, effective immediately.

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In connection with its entry into the Purchase Agreements, Keros also reported that it plans to distribute 25% of any net cash proceeds it receives on or before December 31, 2028 from its global license agreement with Takeda Pharmaceuticals U.S.A., Inc. ("Takeda") to Keros stockholders.

Following the closing of the transactions with ADAR1 and Pontifax, the Company intends to commence a tender offer for up to $194 million in value of shares of the Company’s common stock, subject to market conditions, at a purchase price of $17.75 per share in cash. The Company presently intends to commence the tender offer by the end of October 2025. The Company expects to fund the tender offer from its existing cash and cash equivalents.

"We are pleased to have reached these agreements with ADAR1 and Pontifax, and look forward to completing our capital return program in the near term. The capital return program – which includes an additional commitment to distribute future near-term Takeda proceeds – reflects our confidence in the outlook for Keros and the prospects for our key clinical program, KER-065," said Jean-Jacques Bienaimé, Chair of the Board of Directors. "With a more focused and streamlined organization, supported by a strong financial position, we are moving forward fully focused on the execution of our clinical strategy. We continue to target a first quarter 2026 start of the Phase 2 clinical trial of KER-065 in patients with Duchenne muscular dystrophy ("DMD"), subject to positive regulatory interaction, and believe Keros is well-positioned to deliver meaningful value to both patients and stockholders."

"Our engagement with the management team and Board has delivered results for all stockholders, including a commitment by Keros to return a portion of the Takeda licensing revenue directly to investors," said Daniel Schneeberger, Founder and Chief Investment Officer at ADAR1 Capital Management. "We appreciate the collaborative dialogue we have had with the Company and believe today’s announcement is a thoughtful and positive step toward enhancing long-term stockholder value."

The negotiation and approval of the repurchase transactions with ADAR1 and Pontifax were overseen by a Capital Return Committee of Keros’ Board of Directors, composed entirely of independent and disinterested directors. The Committee recommended that the full Board approve the repurchase transactions and the subsequent tender offer, which the Board approved.

The Purchase Agreements include certain customary standstill, voting and other provisions. Details of the Purchase Agreements will be filed on a Form 8-K with the U.S. Securities and Exchange Commission (the "SEC").

Goldman Sachs & Co. LLC is serving as Keros’ financial advisor, and Cooley LLP is serving as legal counsel.

(Press release, Keros Therapeutics, OCT 15, 2025, sec.gov/Archives/edgar/data/1664710/000110465925099512/tm2528773d1_ex99-1.htm [SID1234656674])

On October 15, 2025 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, reported that it has determined the recommended Phase 2 dose (RP2D) of 1,100 mg once daily for ATRN-119, its oral ATR inhibitor in the monotherapy arm of the ongoing ABOYA-119 Phase 1/2a dose-escalation study, in patients with advanced solid tumors.

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ATR program

Building on the completion of dose escalation and supported by new preclinical data suggesting potential synergistic anti-tumor effects, Aprea is considering further ATRN-119 development in combination approaches that could expand its therapeutic potential. The Company believes ATRN-119’s mechanism of action, favorable safety profile, and pharmacologic characteristics make it an ideal candidate for combination with DNA-damaging agents, including radiation therapy, antibody-drug conjugates and immune checkpoint inhibitors.

As part of this strategic focus, Aprea is pausing further enrollment in both once daily and twice daily monotherapy dosing arms of ABOYA-119. Importantly, patients currently being dosed with ATRN-119 as part of this ongoing clinical trial will continue to have access to therapy without interruption.

The Company is currently in discussions with leading academic centers to explore combining ATRN-119 with radiation in patients with HPV+ head and neck cancer, an indication where synergistic anti-tumor effects have been observed in preclinical data. Additional investigator-led studies evaluating ATRN-119 in combination with an I/O agent and antibody-drug conjugates, are also being explored, based on preclinical evidence that ATR inhibition may enhance anti-tumor immune responses.

Phase 1 monotherapy data in the ABOYA-119 dose-escalation study, ATRN-119 demonstrated:

Favorable tolerability profile with manageable adverse events at the RP2D of 1100 mg once daily
Durable disease stabilization in heavily pretreated patients across multiple tumor types
Dose-proportional pharmacokinetics supporting once-daily dosing
Preliminary signs of clinical activity in biomarker-selected populations
"We are very pleased to have identified the recommended monotherapy Phase 2 dose for ATRN-119, which is an important step in our transition to the next stage of development," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "Based on the growing body of evidence supporting ATR inhibition as a potent sensitizer to DNA-damaging therapies and immunotherapy, we are now considering ATRN-119 in combination approaches that we believe could expand its clinical impact. We believe this candidate’s mechanism, safety profile, and pharmacologic characteristics make it a compelling candidate for pairing with other anti-cancer therapies, including radiation or checkpoint inhibitors, where synergistic anti-tumor effects have been demonstrated preclinically."

A poster titled Updated data from ABOYA-119: A phase 1/2a trial of ATRN-119, a novel macrocyclic ATR inhibitor, in patients with advanced solid tumors harboring DNA damage will be presented at the forthcoming AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) on Friday, October 24, 2025.

WEE1 Program

Aprea continues to advance its lead program, WEE1 kinase inhibitor APR-1051 at full speed. The ongoing Phase 1, first-in-human study (NCT06260514) is actively enrolling patients at three leading clinical sites in the United States. To date, patients with advanced solid tumors harboring specific cancer-associated gene alterations have been treated with APR-1051 at doses up to 150 mg once daily. Early signals of clinical benefit, including disease stabilization in multiple patients, have been observed, supporting continued dose escalation and further clinical evaluation of APR-1051. The Company expects to report clinical data from this study later this month at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) and is planning to further explore safety, pharmacokinetics, and signals of antitumor activity.

(Press release, Aprea, OCT 15, 2025, View Source [SID1234656672])