On September 3, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biopharmaceutical company developing therapeutics using its proprietary INTASYL siRNA gene silencing technology to eliminate cancer, reported that Phio Pharmaceuticals is a presenting company at the H.C. Wainwright 27th Annual Global Investment Conference to be held September 8 – 10, 2025 (Press release, Phio Pharmaceuticals, SEP 3, 2025, View Source [SID1234655732]).

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Mr. Robert Bitterman, President and CEO of Phio Pharmaceuticals will deliver an update on its on-going Phase 1b clinical trial for skin cancer. He will also be discussing strategy and anticipated next steps in the PH-762 development program upon completion of the treatment phase of the study.

· Presentation Details: September 10, 2025 at 1:30-2 PM EST

· Location: 27th Annual H.C. Wainwright Global Investment Conference, Lotte New York Plaza Hotel, New York City, NY

Mr. Bitterman will also be available for one-on-one investor meetings throughout the conference September 8 – 10, 2025. Investors interested in scheduling a meeting with the Phio Pharmaceuticals management team should contact their H.C. Wainwright representative or email [email protected].

On September 3, 2025 Lantern Pharma Inc. (NASDAQ: LTRN), an AI-driven clinical -stage oncology company developing targeted therapies for cancer that are being advanced using its proprietary computational biology and machine learning platform, reported the successful completion of a Type C meeting with the U.S. Food and Drug Administration (FDA) (Press release, Lantern Pharma, SEP 3, 2025, View Source [SID1234655744]). The meeting provided critical guidance on the regulatory pathway and trial design for a planned pediatric trial focused on CNS cancers, including Atypical Teratoid Rhabdoid Tumor (ATRT).

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During the Type C meeting, the FDA provided constructive feedback on the proposed clinical trial structure, which includes a parallel cohort specifically for ATRT patients to accelerate data collection in this ultra-rare population. Additionally, the agency confirmed the potential incorporation of spironolactone as a combination agent, to allow for the assessment of spironolactone’s synergistic effects with Lantern’s lead investigational therapy, LP-184/STAR-001 in enhancing the potential efficacy in CNS cancers. This feedback aligns with Lantern’s strategy to advance precision oncology solutions for pediatric patients facing limited treatment options. Lantern is now preparing to submit an IND (investigational new drug) application amendment for LP-184/STAR-001 under its wholly owned subsidiary, Starlight Therapeutics, based on the guidance and dialogue from the Type C meeting.

Lantern’s program for ATRT has received Rare Pediatric Disease Designation and Orphan Drug Designation from the FDA, underscoring the urgent unmet need for innovative therapies in these aggressive childhood brain cancers. The planned trial is expected to enroll pediatric patients across multiple sites, with primary endpoints focused on progression-free survival, overall response rate, and quality-of-life measures.

"We are thrilled with the constructive dialogue and positive feedback from our Type C meeting with the FDA," said Panna Sharma, President and CEO of Lantern Pharma. "This guidance not only reinforces our trial design but also highlights the potential of our AI platform, RADR, in identifying and optimizing combination regimens like spironolactone for these devastating pediatric CNS cancers. We remain committed to rapidly advancing this program with the aim of bringing hope to children and families affected by brain cancer."

Lantern Pharma continues to leverage its proprietary RADR AI platform to accelerate drug development, reduce costs, and identify patient responders across oncology indications. The company plans to submit an Investigational New Drug (IND) application amendment incorporating the FDA’s guidance in the coming months, with planned trial initiation targeted for Q1 2026.

On September 3, 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 its second CAPTN-3 trispecific antibody, targeting TROP2 in development (Press release, Purple Biotech, SEP 3, 2025, View Source [SID1234655733]).

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Purple Biotech has advanced development of a tri-specific antibody targeting TROP2 from its unique CAPTN-3 platform. Through activation of both the innate and adaptive immune systems, CAPTN-3 platform candidates can generate synergistic responses within the tumor microenvironment (TME) and overcome the immunosuppressive environment, which remains a major challenge in treating solid tumors.

IM1305 (capped-CD3xTROP2xNKG2A) contains a masked anti-CD3 arm, as well as an anti-NKG2A arm, and an anti-TROP2 arm. The potent anti-CD3 arm is masked at the periphery with a cleavable cap, designed to be removed specifically in the TME, which is expected to reduce the risk of off-target cytokine release and potentially enables higher dosing to achieve increased efficacy.

Encouraging preclinical results targeting TROP2 have demonstrated sustained tumor regression of human triple negative breast cancer (TNBC) in a mouse model, with no detectable tumor recurrence following treatment completion. Significant cell death induction was demonstrated in multiple tumor types, including TNBC, tongue and hypopharyngeal cancers, pancreatic and gastric cancers, at remarkably low doses (EC50 1-5 pM).

TROP2 is broadly expressed across major solid tumors (e.g., breast, lung, gastrointestinal, ovarian) and is associated with poor prognosis. Supported by prior clinical validation from approved TROP2-directed antibody-drug conjugates (ADCs), the broad potential of targeting TROP2 makes it a compelling target for the CAPTN-3 platform.

Unlike ADCs or monospecific antibodies, CAPTN-3 combines selective TROP2 binding with multi-effector immune recruitment (T and NK cells). This immune synapse–driven cytotoxicity is expected to potentially be independent of TROP2 density, providing a strong rationale for activity in non-ADC settings and across diverse tumor types.

"We are expanding our portfolio with the development of this novel tri-specific antibody to leverage our accumulated knowledge and technological advancements from the development of IM1240. By optimizing the CAPTN-3 platform, we are able to accelerate the time of development for the new TROP2 targeted tri-specific antibody." said Gil Efron, CEO of Purple Biotech Ltd." There is growing interest in TROP2 as a therapeutic target and excitement around next-generation engagers, and we believe our TCE platform is uniquely positioned to capitalize on this momentum. CAPTN-3 is a platform that can potentially generate multiple programs and expand our partnering opportunities."

On September 3, 2025 Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, reported participation and presentation of initial Phase 1 data of ENV105 in non-small cell lung cancer by Principal Investigator Dr. Karen Reckamp. Dr. Reckamp will present at the World Lung Cancer Conference which takes place September 6-9, 2025, at the Fira de Barcelona Gran Via in Barcelona, Spain (Press release, Kairos Pharma, SEP 3, 2025, View Source [SID1234655745]).

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Dr. Reckamp’s presentation, "Combination of Osimertinib and Carotuximab for Advanced, EFGR-Mutated Non-Small Cell Lung Cancer Patients," focuses on combination therapy of ENV105 with osimertinib for the treatment of non-small cell lung cancer. More information on the trial can be found here.

The primary objective of the open-label trial is to evaluate the safety and tolerability of the combination therapy.

On September 3, 2025 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported that John Celebi, President and Chief Executive Officer, will participate in 1×1 investor meetings at the H.C. Wainwright 27th Annual Global Investment Conference on Monday, September 8, 2025 (Press release, Sensei Biotherapeutics, SEP 3, 2025, View Source [SID1234655734]).

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An on-demand corporate presentation will be available here on September 5, 2025, at 7:00 a.m. ET. A replay of the webcast will be available in the Investors section of the Sensei website for approximately 90 days following the event.