On December 4, 2025 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, reported that it will present new preclinical data from its CAPTN-3 platform of conditionally activated tri-specific antibodies at the upcoming European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology (ESMO-IO) 2025 Annual Congress being held from December 10-12, 2025, in London, United Kingdom.

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Presentation Details:

• Conference: ESMO (Free ESMO Whitepaper) Immuno-Oncology (ESMO-IO) 2025 Annual Congress
• Title: CAPTN-3 unique design demonstrated by 2 novel platform compounds
• Presenter: Dr. Hadas Reuveni
• Presentation Number: FPN# 287P
• Session Title: Poster Presentation
• Date/Time: Wednesday, December 10, 2025, 17:15
• Location: London, UK

"Our CAPTN-3 platform can produce novel tri-specific antibodies that engage T cells, NK cells and bind to tumor associated antigens. The powerful synergy we have seen in preclinical studies strengthens our conviction in not only the platform, but also in this novel structure to overcome tumor evasion and drug resistance. We look forward to showcasing new data from our lead CAPTN-3 program, IM1240, in multiple PD-1 resistant models, and new data demonstrating the platform versatility with multiple tri-specific antibodies" said Gil Efron, Chief Executive Officer of Purple Biotech, Ltd.

The poster will be accessible under the Publications section of the Purple Biotech website following the congress.

(Press release, Purple Biotech, DEC 4, 2025, View Source;id=374459&p=2412439&I=1206939-c7Z3G6f3m8 [SID1234661130])

On December 4, 2025 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported three positive clinical data update presentations at the World Federation of Neuro-Oncology Societies/Society for Neuro-Oncology (WFNOS/SNO) Annual Meeting, November 19-23, 2025 in Honolulu, Hawaii. The World Federation of Neuro-Oncology Societies (WFNOS) and Society for Neuro-Oncology (SNO) advance research, education, and clinical care for patients with tumors of the central nervous system.

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"Real world clinical experience with REYOBIQ in both primary and metastatic CNS cancers continues to show a promising safety profile and signs of efficacy," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "This expanding clinical data set around REYOBIQ coupled with substantial progress bringing our CNSide diagnostic portfolio to market provides our team at Plus with growing confidence that we can achieve our goal of materially improving survival rates for patients with CNS cancers."

KEY HIGHLIGHTS:

Phase 1 Multicenter Study of Multiple Doses of Rhenium (186Re) Obisbemeda (Reyobiq) for Leptomeningeal Metastases: Rationale, Design, and Preliminary Cohort 1 Data

Overview:

Completed ReSPECT-LM single dose trial showed REYOBIQ was well-tolerated up to a maximum tolerated dose of 66mCi, with a recommended phase 2 dose of 44.1 mCi, and absorbed doses delivered of >300 Gy observed
ReSPECT-LM open label, multidose Phase 1/2 trial initiated to identify maximum tolerated dose across varying dosing intervals and to characterize efficacy of multiple doses at optimal dose selected by assessing response using CNSide CSF tumor cell enumeration test

Response:

Enrollment in Cohort 1 has begun with delivery of 13.2 mCi at 3 intervals
Three patients enrolled as of data cutoff: one patient has received all doses without dose limiting toxicity

Next Steps:

Phase 1b/2a dose optimization trial is enrolling with the ultimate goal of improving outcomes for LM patients

Phase 1/2 ReSPECT-GBM Trial of Rhenium (186Re) Obisbemeda in Recurrent Glioblastoma: Safety and Efficacy from the Phase 1 and Update on Phase 2

Overview:

Phase 1 dose-escalation study completed, with patients dosed from 1.0 mCi to 41.5 mCi, achieving a maximum absorbed tumor dose of 739.5 Gy. Dose 22.3 mCi was selected as the recommended Phase 2 dose due to its favorable safety profile
Ongoing Phase 2 study has enrolled 24 of planned 34 patients as of data cutoff; study continues to evaluate safety and efficacy at the Phase 2 recommended dose

Safety:

Across all patients treated in both Phase 1 and 2, most treatment-related adverse events were Grade 1 or 2, including lymphopenia (7.9%), cognitive disorder (7.0%), and headache (7.0%), with no treatment-related deaths or study discontinuations due to serious adverse reactions (SARs)

Response:

Efficacy data from Phase 1 cohorts 1 to 6 showed a median overall survival of 17 months for patients receiving ≥100 Gy, compared to 6 months for those receiving <100 Gy, surpassing historical bevacizumab monotherapy outcomes
SPECT/CT imaging continues to confirm high tumor-specific radiation retention, with minimal systemic exposure

Next Steps:

Phase 2 continues to enroll
REYOBIQ has demonstrated promising safety and efficacy profile, supporting continued investigation as a novel therapeutic for recurrent GBM

Assessment of rhenium-186 obisbemeda (186RNL) therapy for recurrent glioblastoma (rGBM) using MRI and SPECT imaging biomarkers

Overview:

Phase 1 ReSPECT-GBM showed promising improvements in overall survival
REYOBIQ efficacy also evaluated using MRI and SPECT imaging biomarkers

Response:

REYOBIQ dose positively correlates with treatment coverage ratio, time to peak, and progression free survival; negatively correlates with mean transit time and tumor volume
Based on a Wilcoxon Signed Rank test on 23 patients receiving REYOBIQ, untreated tumor volume was significantly increased relative to treated tumor volume. Overall survival negatively associated with tumor volume

Conclusion:

MRI combined with SPECT imaging biomarkers effectively evaluate REYOBIQ in recurrent GBM treatment, guiding patient specific planning

Plus Therapeutics and its wholly owned subsidiary, CNSide Diagnostics focused on central nervous system metastases management, each hosted a booth at the WFNOS/SNO Annual Meeting exhibit hall.

About LM
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.

About REYOBIQ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.

(Press release, Plus Therapeutics, DEC 4, 2025, View Source [SID1234661129])

On December 4, 2025 Syntara Limited (ASX: SNT), a clinical-stage drug development company, reported that two posters detailing the preclinical findings and clinical data1 from its Phase 2a trial evaluating amsulostat (200 mg BID) in combination with ruxolitinib (RUX) for the treatment of myelofibrosis (MF) will be presented at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH) (Free ASH Whitepaper), taking place in Orlando, Florida, from 6-9 December 2025.

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One poster presentation, titled "A Phase 1/2a Trial of Amsulostat, a Novel Pan-Lysyl Oxidase Inhibitor, in Patients with Advanced Myelofibrosis as an Add-On to Ruxolitinib Treatment for Up to 52 Weeks," will be featured in the session "Myeloproliferative Syndromes: Clinical and Epidemiological" on Saturday 6 December (EST).

In a concurrent "Bone Marrow Microenvironment" session, Syntara will also present preclinical research highlighting amsulostat-sensitive, lysyl oxidase–mediated modulation of growth factor signaling, titled "Lysyl Oxidases Directly Control Cell Surface Abundance of Platelet-Derived Growth Factor Receptors and Signaling in Osteoblasts."

Attending the ASH (Free ASH Whitepaper) Annual Meeting on behalf of Syntara will be Dr. Jana Baskar, CMO, Dr. Wolfgang Jarolimek, Head of Drug Discovery, and Gary Phillips, CEO.

Mr Phillips said: "The ASH (Free ASH Whitepaper) Annual Meeting and Exposition is the leading global forum for advancing research in haematological malignancies. We welcome the opportunity to present our recent clinical and mechanism of action data on amsulostat to the global haematology community and to discuss future clinical and commercial pathways with potential collaborators."

Syntara has received feedback from the US Food and Drug Administration (FDA) on the recommended pathway for further development of amsulostat and, with the support of an experienced and well renowned advisory board, is progressing the protocol for the next trial. Amsulostat is also being evaluated in two Phase 1c/2 trials of myelodysplastic syndrome which are currently recruiting and expected to deliver preliminary results in 2026.

(Press release, Syntara, DEC 4, 2025, https://mcusercontent.com/add2e2fa70ec3d0eeaf2a93cc/files/a7cc5fc7-eb21-174a-d2db-66f2331f2272/03033592.pdf [SID1234661128])

On December 4, 2025 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported data from a Phase 1b trial of enozertinib (ORIC-114) at the ESMO (Free ESMO Whitepaper) Asia Congress 2025. Data in previously treated NSCLC patients with EGFR atypical mutations were presented at a mini-oral session, and the presentation can be found in the publication section of ORIC’s website here. In addition, compelling preliminary data in 1L NSCLC patients with EGFR P-loop and alpha C-helix compressing (PACC) mutations were disclosed.

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"Enozertinib was purposefully designed to be highly brain-penetrant and exquisitely selective in order to address the limitations of available therapies and potentially drive differentiated durability. These data provide clinical support for this design approach, demonstrating strong systemic and CNS activity in NSCLC patients with EGFR PACC mutations," said Pratik S. Multani, M.D., chief medical officer. "The profile we have seen with enozertinib compares favorably to other investigational therapies and continues to support enozertinib’s best-in-class potential."

Enozertinib Phase 1b Trial Design
Enozertinib is being evaluated in a Phase 1b trial in patients with locally advanced or metastatic NSCLC with EGFR atypical mutations. Notably, enrollment allows patients with active untreated brain metastases. Prior therapies in previously treated patients include chemotherapy and EGFR targeted therapies. The primary endpoint of the trial is to determine the recommended Phase 2 dose (RP2D), and secondary endpoints include investigator-assessed objective response rate (ORR), disease control rate (DCR), and safety.

Previously Treated NSCLC Patients with EGFR Atypical Mutations
As of the August 29, 2025 cutoff date, 47 patients were dosed — 25 patients received 80 mg QD oral enozertinib and 22 patients received 120 mg QD. Patients were heavily pretreated, having received a median of 2 prior therapies, with 81% of patients having received a prior EGFR targeted therapy, including osimertinib and afatinib. Brain metastases were present in 55% of patients at baseline, including those with active brain metastases.

Preliminary Safety Analysis
Enozertinib was well tolerated with mostly Grade 1 or 2 treatment-related adverse events (TRAEs) and no significant off-target toxicities. Most frequent TRAEs included diarrhea, paronychia, and stomatitis. There were no treatment discontinuations related to TRAEs. High rates of early dose reductions occurred in the 120 mg cohort compared to the 80 mg cohort, such that most patients received an effective dose of 80 mg QD.

22 patients with PACC mutations were efficacy evaluable, all receiving an effective dose of 80 mg QD, consisting of 12 patients from the 80 mg cohort and 10 patients from the 120 mg cohort who underwent early dose reduction.

Preliminary Activity Analysis
In the 22 efficacy evaluable patients with PACC mutations, enozertinib demonstrated strong systemic and CNS antitumor activity.

36% confirmed ORR and 91% DCR, with comparable rates in patients with brain metastases at baseline
Responses observed across a wide range of EGFR PACC mutations including in the most prevalent mutations (i.e., G719X, S768I), and in a broad spectrum of PACC complex mutations
As of the data cutoff (at a median follow-up of over 32 weeks), 75% of responders remained on treatment
1L NSCLC Patients with EGFR PACC Mutations (Preliminary)
As of the November 18, 2025 cutoff date, 10 efficacy evaluable patients were dosed with 80 mg QD oral enozertinib. 60% of these patients had brain metastases at baseline, all of which were active and untreated. The safety profile to date in this cohort of patients is in line with the safety profile at the 80 mg QD dose level in other cohorts. Enozertinib demonstrated strong preliminary systemic and CNS activity, including 80% ORR and 100% intracranial ORR in patients with measurable CNS disease (investigator-assessed by RECIST).

Next Steps
Based on these data, 80 mg QD oral enozertinib has been selected as the dose for potential Phase 3 development. Enrollment and follow-up continues in 1L EGFR PACC patients with the next update expected in mid-2026, ahead of initiation of a potential Phase 3 trial.

Conference Call and Webcast Details
In conjunction with the ESMO (Free ESMO Whitepaper) Asia Congress, ORIC will host a conference call and webcast on Saturday, December 6, 2025, at 8:00 pm ET. To join the conference call via phone and participate in the live Q&A session, please pre-register online here to receive a telephone number and unique passcode required to enter the call. A live webcast and audio archive of the conference call will be available through the investor section of ORIC’s website at www.oricpharma.com. The webcast will be available for replay for 90 days following the presentation.

(Press release, ORIC Pharmaceuticals, DEC 4, 2025, View Source [SID1234661127])

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])