On December 4, 2025 NovaBridge Biosciences (Nasdaq: NBP) (NovaBridge or the Company) a global biotechnology platform company committed to accelerating access to innovative medicines, reported that new data from the expanded Phase 1 dosing study for ragistomig, a 4-1BB X PD-L1 bispecific antibody, will be presented in a poster at the European Society for Medical Oncology – Immuno-Oncology Congress 2025 (ESMO-IO 2025) by co-developer ABL Bio. The poster (Abstract #688) will be presented by Gerald Falchook, MD, Director of the Sarah Cannon Research Institute (SCRI) at HealthONE Denver, on Wednesday, December 10th at 5:30 PM GMT.

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"The expanded Phase 1 dosing study achieved its objective of extending the therapeutic window for ragistomig by defining a new dosing schedule that could provide strong anti-tumor efficacy and a more manageable tolerability profile, including improved hepatic safety. The data build on promising Phase 1 data presented at ASCO (Free ASCO Whitepaper) 2024 and support progression to combination studies which could significantly advance patient care," said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge.

"Ragistomig was designed to deliver new therapeutic options for patients who have developed resistance or relapsed after treatment with checkpoint inhibitors, a multi-billion dollar drug class that serves as the cornerstone of care for many cancers. We are encouraged by the promising ragistomig advancements and data that will be presented at ESMO (Free ESMO Whitepaper)-IO and look forward to continuing the program in collaboration with our partner, ABL Bio," said Sean Fu, PhD, Chief Executive Officer of NovaBridge.

ESMO-IO Meeting information:

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Title: Phase 1 Clinical Trial of Ragistomig (ABL503/TJ-L14B: PD-L1 × 4-1BB bispecific antibody) Q6W Dosing Balances Favorable Safety and Sustained Efficacy Through Extended Immunologic Memory and Reinvigoration of CD8+ T Cells
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Abstract #688
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Date and Time: Wednesday, December 10th at 5:30 PM GMT
A copy of the poster will be available here after the session. To review an overview of the Phase 1 dose escalation data, click here.

About Ragistomig

Ragistomig (also known as ABL503) is a differentiated novel bispecific that integrates a single-chain, Fc-silent PD-L1 segment as a tumor engager and 4-1BB segment as a conditional T cell activator. It was developed using ABL Bio’s "Grabody-T" bispecific antibody platform technology to overcome resistance to PD-(L)1 inhibition and stimulate 4-1BB activation only in the presence of PD-L1 expressing tumor cells, to minimize the risk of off-tumor toxicity. Preclinical studies demonstrated that the bispecific antibody showed better anti-tumor activity than its single-agent components. A Phase 1 dose expansion study (NCT04762641) is currently being conducted in the U.S. and South Korea. The study was designed with a primary endpoint of defining the dose-limiting toxicity and adverse event profile of ragistomig, as well as to observe the objective response rate, pharmacokinetic and immunogenicity profiles and other secondary endpoints.

Ragistomig (also known as ABL503) is being jointly developed with ABL Bio

ASCO 2024: the 2024 American Society for Clinical Oncology Annual Meeting; Q6W: every six weeks

(Press release, NovaBridge Biosciences, DEC 4, 2025, View Source [SID1234661123])

On December 4, 2025 Alpha-9 Oncology, a clinical-stage radiotherapeutic company developing targeted cancer therapies, reported the initiation of dosing in a Phase 1 study evaluating A9-3408, a novel Actinium-225-based radiotherapeutic targeting melanocortin 1 receptor (MC1R) for the treatment of patients with melanoma. The Phase 1 study is a multi-center, open-label trial designed to evaluate the safety, dosimetry, and dose escalation of A9-3408 in patients with MC1R-positive melanoma, who have progressed on standard-of-care therapies.

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This milestone advances Alpha-9’s melanoma program, which first entered the clinic last year with A9-3202, a Gallium-68-based imaging agent used to assess MC1R expression and identify patients for the A9-3408 therapeutic study.

"Dosing the first patient with our MC1R radiotherapeutic marks an important milestone for the company and validates our internal R&D platform," said Paul Blanchfield, Chief Executive Officer, Alpha-9 Oncology. "We are excited to have initiated trials for our first therapeutic program and look forward to advancing additional best-in-class assets into the clinic as we aim to bring novel, life-improving treatments to people living with cancer."

"MC1R is an ideal target due to its high expression in melanoma and limited presence in healthy tissue," said Robert Meehan, M.D., Chief Medical Officer at Alpha-9. "Despite advances in immunotherapy, significant unmet needs remain for patients who progress on current standard of care. In our A9-3202 imaging study, 92% of patients had strong MC1R expression after progression on immunotherapy, demonstrating the potential for this program to provide a new modality for patients."

Dr. Meehan recently joined Alpha-9 as Chief Medical Officer, bringing progressive leadership experience in biopharma and biotechnology, specializing in the creation of complex, novel development programs. Dr. Meehan is a board-certified physician trained in hematology and oncology, with expertise in all phases of drug development across multiple modalities. Prior to Alpha-9, Dr. Meehan was the Senior Vice President, Clinical Development at Dragonfly Therapeutics, held multiple senior clinical leadership roles at Moderna, and was a staff clinician in the Developmental Therapeutics Clinic at the National Cancer Institute.

Alpha-9’s platform is built on a systematic approach to molecule design, optimizing binders, linkers, and chelators to create radiotherapeutics with superior uptake and retention in tumors while minimizing off-target effects. The advancement of the MC1R program highlights the company’s capability to develop best-in-class molecules and deliver on the promise of precision oncology.

(Press release, Alpha9 Oncology, DEC 4, 2025, View Source [SID1234661138])

On December 4, 2025 Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company focused on transforming breast cancer treatment and prevention, reported the completion of a Type C meeting with the U.S. Food and Drug Administration ("FDA") on November 17, 2025, to review regulatory strategy for advancing (Z)-endoxifen. During the meeting, the FDA provided the Company feedback on potential expedited regulatory pathways and development options across metastatic disease, neoadjuvant treatment, and breast cancer risk-reduction settings.

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The meeting focused on clinical development design, endpoint strategy, and pathways that could support a streamlined registrational approach. Atossa believes the FDA interaction meaningfully clarified potential routes to accelerate clinical development and regulatory review for (Z)-endoxifen, helping to position the Company to pursue a faster and more focused development strategy across multiple breast cancer indications.

"This meeting was a meaningful development milestone for our programs," said Steven Quay, M.D., Ph.D., Atossa’s President and Chief Executive Officer. "We used this discussion to incorporate FDA feedback into our development planning that could meaningfully shorten our regulatory timeline. We continue to aggressively execute the advancement of (Z)-endoxifen across the breast cancer continuum and toward potential registration pathways."

This includes multiple high-value clinical settings, including:

Metastatic breast cancer (mBC): A dose-ranging study is in preparation as part of the Company’s strategy to support registrational development.
Neoadjuvant ER+/HER2- breast cancer: Enrollment and data generation continue in the Phase 2 EVANGELINE trial.
Breast cancer risk-reduction: Development includes a low-dose strategy targeting mammographic breast density and overall breast cancer risk.
In support of its metastatic breast cancer program, Atossa recently submitted an Investigational New Drug application ("IND") to the FDA and is awaiting feedback. The Company also anticipates additional IND submissions in 2026 to advance combination strategies and explore opportunities beyond monotherapy and breast cancer.

"Our clinical program is now structured around decisive value-creating milestones," said Janet Rea, MSPH, Senior Vice President of Research and Development. "We have completed multiple clinical trials involving nearly 800 participants, and are optimistic that this foundation, combined with anticipated upcoming data, and FDA input supports an active push towards multiple regulatory endpoints."

About (Z)-Endoxifen

(Z)-endoxifen is a highly potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with demonstrated ability to inhibit and potentially degrade estrogen receptors. It has shown activity even in tumors that have developed resistance to other endocrine therapies. Beyond its anti-estrogenic properties, (Z)-endoxifen also targets the oncogenic signaling pathway, protein kinase C beta 1 (PKCβ1), at clinically achievable blood and tumor levels. (Z)-endoxifen also seems to deliver comparable or superior bone-protective effects relative to tamoxifen.

Atossa is developing a proprietary enteric oral formulation of (Z)-endoxifen that bypasses stomach acid, which would otherwise partially convert the active (Z)-isomer to its inactive (E)-form. We believe this innovation allows for optimal bioavailability and therapeutic integrity. Clinical studies have shown Atossa’s (Z)-endoxifen to be well tolerated in both healthy women and those with breast cancer. In nearly 800 adults (healthy volunteers and breast cancer patients) receiving doses up to 360 mg/day, no maximum tolerated dose (MTD) has been identified, supporting continued dose-range exploration.

Atossa’s (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including four recently issued U.S. patents and numerous pending applications worldwide.

(Press release, Atossa Therapeutics, DEC 4, 2025, View Source [SID1234661139])

On December 4, 2025 Protara Therapeutics, Inc. (Nasdaq: TARA) ("Protara"), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported that it has commenced an underwritten public offering of $75 million in aggregate of shares of its common stock or, in lieu of issuing common stock to certain investors, pre-funded warrants to purchase shares of its common stock. All of the shares of common stock and pre-funded warrants to be sold in the proposed offering will be offered by Protara. In addition, Protara expects to grant the underwriters a 30-day option to purchase additional shares of common stock at the public offering price, less underwriting discounts and commissions. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering. Protara intends to use the net proceeds received from the offering to fund the clinical development of TARA-002, as well as the development of other clinical programs. Protara may also use the net proceeds from the offering for working capital and other general corporate purposes.

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J.P. Morgan, TD Cowen and Piper Sandler are acting as joint book-running managers of the proposed offering.

The shares of common stock and the pre-funded warrants will be issued pursuant to a shelf registration statement on Form S-3 (File No. 333-275290) that was declared effective on November 14, 2023 by the U.S. Securities and Exchange Commission (the "SEC"). The offering is being made only by means of a preliminary prospectus supplement and the accompanying prospectus. A preliminary prospectus supplement and the accompany prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from the offices of J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or by email at [email protected] and [email protected]; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or by email at [email protected]; or Piper Sandler & Co., 350 North 5th Street, Suite 1000, Minneapolis, Minnesota 55401, Attention: Prospectus Department, by telephone at (800) 747-3924, or by email at [email protected].

Before investing in the offering, interested parties should read the preliminary prospectus supplement and related prospectus for this offering, the documents incorporated by reference therein and the other documents Protara has filed with the SEC. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the applicable securities laws of such state or jurisdiction.

(Press release, Protara Therapeutics, DEC 4, 2025, View Source [SID1234661126])

On December 4, 2025 iOnctura, a clinical-stage biopharmaceutical company combating neglected and hard-to-treat cancers, reported it has dosed the first patient in its Phase I/II clinical trial evaluating roginolisib in patients with MF who are no longer responding to JAK inhibition. Further details of the trial will be presented in a poster presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida on Sunday, December 7 at 6pm EST.

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This milestone marks an important step toward addressing the significant unmet medical needs of MF patients who face diminishing therapeutic options, as their disease progresses or becomes resistant to standard-of-care JAK inhibitor treatment.

The Phase I/II trial is part of a comprehensive development program evaluating next-generation PI3Kδ inhibitor roginolisib’s tolerability and anti-tumor response across a number of solid and hematologic malignancies.

"Based on non-clinical data being presented at ASH (Free ASH Whitepaper), we anticipate that targeting both the PI3Kδ and JAK pathways could have a synergistic effect in MF — an approach that has previously eluded older generation PI3Kδ inhibitors because of their unfavorable tolerability profiles." said Dr Michael Lahn, Chief Medical Officer of iOnctura.

Overactivation of the PI3K-Akt signaling pathway contributes to the occurrence and progression of cancer[1]. In MF, pathway activation is a well described mechanism of resistance in response to JAK inhibition[2]. Inhibition of this pathway using roginolisib may overcome the lack of response and lead to a beneficial therapeutic effect. Non-clinical evidence in support of this mechanism is being presented at ASH (Free ASH Whitepaper) on Monday, December 8, 2025 at 6pm EST.

These data demonstrate monotherapy activity of roginolisib against MF cell lines and in vitro models of primary MF cells. Further, roginolisib and JAK inhibition (ruxolitinib or momelotinib) exerts a synergistic anti-cancer effect. These data support the rationale behind the ongoing HEMA-MED clinical trial.

Professor Alessandro Vannucchi, Professor of Hematology and Department Head of the Center for Research and Innovation in Myeloproliferative Neoplasms (CRIMM) at the University of Florence, Florence, Italy and Principal Investigator of the HEMA-MED study said: "Myelofibrosis patients often have suboptimal responses to ruxolitinib and/or acquire resistance over time. Roginolisib’s intriguing mechanism of action and favorable toxicity profile position it as a compelling partner for ruxolitinib. By combining these agents, we could unlock more durable responses and redefine therapeutic expectations for this challenging rare disease."

In addition to the two posters related to MF, trials in progress posters for the ongoing investigations of roginolisib in peripheral T-cell lymphoma and chronic lymphocytic leukemia (CLL) will also be presented at ASH (Free ASH Whitepaper).

iOnctura poster presentations at the 67th ASH (Free ASH Whitepaper) Annual Meeting in Orlando, Florida, USA:

1. A Vannucchi et al. Trial in progress: Sunday, December 7, 06:00 PM – 08:00 PM EST

Abstract 25-4153: A study of roginolisib in combination with ruxolitinib in patients with myelofibrosis who are unresponsive to JAK inhibitors (HEMA-MED)

2. M Balliu et al.: Monday, December 8, 06:00 PM – 08:00 PM EST

Abstract 25-7102: The selective PI3Kd inhibitor roginolisib synergizes with ruxolitinib against progenitor cells from naïve and JAK-inhibitor-refractory/resistant patients with myelofibrosis

3. D Sibon et al. Trial in progress: Sunday, December 7, 06:00 PM – 08:00 PM EST

Abstract 25-11050: PlatΤform: A multicenter, multi-arm, academic platform trial evaluating novel agents and combinations in relapsed or refractory peripheral T-cell lymphomas

4. J Brown et al. Trial in progress: Sunday, December 7, 06:00 PM – 08:00 PM EST

Abstract 25-7765: Roginolisib (IOA-244), an orally bioavailable, selective PI3Kδ inhibitor, in combination with venetoclax and rituximab in patients with relapsed chronic lymphocytic leukemia (CLL)

About myelofibrosis (MF)

MF is a rare myeloproliferative neoplasm marked by activation and growth of mutated cells in the bone marrow, with approximately 0.5 cases per 100,000 individuals diagnosed globally a year[3].

JAK inhibitors are a key treatment option for MF patients and improve symptoms and quality of life, but approximately half of patients discontinue therapy within three years[4]. Reasons for discontinuation include disease progression, tolerability and adverse events and death resulting from resistance to the JAK therapy[5],[6].

About the HEMA-MED clinical trial

The HEMA-MED trial (NCT06887803) is a prospective, multi-center, open-label Phase I/II single arm trial consisting of two parts. Part 1 (Phase 1) will enroll 13 patients to assess the safety of the combination of the PI3Kδ inhibitor roginolisib in combination with the JAK inhibitor ruxolitinib, and Part 2 (Phase 2) will expand to enroll 13 additional patients to further allow the assessment of benefit/risk for all 26 patients. In addition to safety, the secondary endpoints of the HEMA-MED trial include blood biomarker and spleen reduction responses, and improvements of MF related symptoms. Exploratory measures will assess endpoints associated with the mechanism of action (MOA) of roginolisib.

(Press release, iOnctura, DEC 4, 2025, View Source [SID1234661140])