On November 24, 2025 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported the publication of data from its Acclaim-1 Phase 1 clinical trial of Reqorsa Gene Therapy (quaratusugene ozeplasmid) in combination with Tagrisso (osimertinib) in patients with advanced non-small cell lung cancer (NSCLC) in the peer-reviewed journal Clinical Lung Cancer.

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"We believe REQORSA is an innovative gene therapy that may benefit many lung cancer patients, and we are pleased to see these data for REQORSA published and shared with the scientific community," said Ryan Confer, President and Chief Executive Officer at Genprex. "Genprex is thankful to the patients who participated in this study, along with the investigators who made the completion of the study possible. We believe this new mechanism and novel approach targeting lung cancer, which comes with a strong safety profile and early signs of efficacy, is paving new ground in the fight against lung cancer."

The Acclaim-1 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with osimertinib in patients with late-stage NSCLC with activating epidermal growth factor receptor (EGFR) mutations whose disease progressed after treatment with osimertinib (osimertinib monotherapy or osimertinib combination therapy).

The Phase 1 dose escalation portion of the trial was designed primarily to assess safety, however, the Company believes promising efficacy results were also observed. The reported results showed no Dose Limiting Toxicities (DLTs), established a Recommended Phase 2 Dose (RP2D) of 0.12 mg/kg (the highest dose level administered in the trial) and provided data showing early efficacy of REQORSA in combination with osimertinib.

Of the 12 patients treated with escalating doses of REQORSA and standard doses of osimertinib, all of whom had progressed on osimertinib containing regimens, three patients had experienced prolonged time to progression, including one with continuing partial response.

Specifically, one patient at the 0.06 mg/kg dose level, previously treated with carboplatin, pemetrexed and osimertinib, had a partial remission by investigator evaluation, and as of the data from April 2025 used in the published manuscript had continued to receive study treatment for 47 cycles over 32 months. The patient continues to receive REQORSA and osimertinib treatment in the trial more than three years after enrolling.A second patient at the 0.12 mg/kg dose level who was previously treated with cisplatin, pemetrexed, carboplatin and osimertinib had stable disease and received REQORSA for 32 cycles, or approximately 24 months, until disease progression occurred.

A third patient who was at the 0.09 mg/kg dose level, previously treated with osimertinib, had stable disease and received 14 cycles over approximately 10 months before disease progression occurred.

The extended Progression Free Survival (PFS) of each of these patients is consistent with long-term PFS seen in several patients in prior early-stage clinical trials of REQORSA and is not expected with treatment with osimertinib alone after progression on osimertinib.

REQORSA administration was generally well tolerated and there were no DLTs. The administration was associated with a delayed infusion-related reaction of muscle aches, fever and chills in some patients, which we believe is similar to reactions seen with the administration of antibodies routinely used in oncology treatment. This was managed with prophylactic steroids, acetaminophen and diphenhydramine, and symptoms decreased with repeat cycles.

(Press release, Genprex, NOV 24, 2025, View Source [SID1234660897])

On November 24, 2025 Theralase Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase" or the "Company"), a clinical stage pharmaceutical company pioneering light, radiation, sound and drug-activated therapeutics for the treatment of cancer, bacteria and viruses reported that it has entered into an agreement with Research Capital Corporation ("RCC") as the sole agent and bookrunner on a commercially reasonable "best efforts" agency basis, for a brokered private placement offering ("Offering") of units of the Company ("Units") at a price of C$ 0.17 per Unit to raise a minimum of C$ 4,500,000 and up to a maximum of C$5,500,000 in aggregate gross proceeds.

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Each Unit will consist of one common share of the Company ("Common Share") and one Common Share purchase warrant ("Warrant"). Each Warrant shall entitle the holder thereof to purchase one Common Share ("Warrant Share") at an exercise price of $CAN 0.21 per Warrant Share at any time for a period of 60 months following the closing of the Offering. The Company will use commercial reasonable efforts to obtain the necessary approvals to list the Warrants on the TSX Venture Exchange ("TSXV").

The Company will grant the Agent an option ("Agent’s Option") to increase the size of the Offering by up to C$1,000,000 in Units by giving written notice of the exercise of the Agent’s Option, or a part thereof, to the Company at any time up to 48 hours prior to closing of the Offering.

The Company plans to use the minimum proceeds of the financing for:

Furtherance of a Phase II non-muscle invasive bladder cancer clinical study
Good Laboratory Practice ("GLP") toxicology studies to support clinical development for the intravenous use of Rutherrin (Ruvidar + transferrin) in the treatment of various cancers
working capital and general corporate purposes
If the maximum proceeds are achieved, then the following strategic initiatives will be added:

GLP toxicology studies to support clinical development for the topical use of Ruvidar in the treatment of herpes simplex virus induced cold sores
design, development and commercialization of products in the device division
The Offering is scheduled to close on or about the week of December 1, 2025, or such other date as the Company and the Agent may agree upon, and is subject to the receipt of all necessary approvals; including, the approval of the TSXV.

The Offering will take place by way of:

a private placement pursuant to National Instrument 45-106 – Prospectus Exemptions under Part 5A, as amended by CSA Coordinated Blanket Order 45-935 – Exemptions from Certain Conditions of the Listed Issuer Financing Exemption ("Listed Issuer Financing Exemption" or "LIFE"), to qualified investors in all the provinces of Canada, except Québec and
in other jurisdictions where the Offering can lawfully be made; including, the United States under applicable private placement exemptions. Such sales to investors in the United States will be subject to applicable United States securities laws and restrictions on its securities purchased.
The Units issued under the Listed Issuer Financing Exemption will not be subject to resale restrictions pursuant to applicable Canadian securities laws.

The LIFE offering document ("Offering Document") related to the Offering can be accessed under the Company’s profile at www.sedarplus.ca or on the Company’s website at: www.theralase.com.

Prospective investors should read this Offering Document before making an investment decision.

Upon closing of the Offering, the Company shall pay to RCC:

a cash commission equal to 7% of the aggregate gross proceeds of the Offering payable in cash (subject to a reduction for orders on the "president’s list"); and
non-transferrable broker warrants of the Company exercisable to acquire that number of Units equal to 7% of the number of Units issued under the Offering (subject to a reduction for orders on the "president’s list"), at an exercise price of C$0.17 per Unit, expiring 60 months after the date of the closing of the Offering.

(Press release, Theralase, NOV 24, 2025, View Source [SID1234661918])

On November 24, 2025 IN8bio, Inc. (the "Company") reported consolidated data, a summary of which is located below, from its investigator-sponsored Phase 1 single-center clinical trial of INB-200 and its Company-sponsored Phase 2 multi-center clinical trial of INB-400 for the treatment of patients with newly diagnosed glioblastoma ("GBM") in poster and oral presentations at the 2025 Society for Neuro-Oncology ("SNO") Annual Meeting on November 21 and 22, 2025.

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Summary of Clinical Update from Phase 1 Trial of INB-200 and Phase 2 Trial of INB-400

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Across the two trials, 17 patients were treated with the Company’s DeltExTM Drug Resistant Immunotherapy ("DeltEx DRI") gamma-delta T cells, with 14 patients receiving repeated (3 up to 6) doses. 10 additional patients were consented contemporaneously but received only the standard-of-care Stupp protocol ("SOC") and were monitored for progression and survival.

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Patients treated with repeated doses of DeltEx DRI cells achieved a median progression-free survival ("mPFS") of 13.0 months (n=14), compared to the mPFS of 6.6 months for patients receiving only SOC (n=10).

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Patients receiving repeated doses of DeltEx DRI cells have not yet reached median overall survival ("mOS"), which continues to climb at 16.4+ months as of October 31, 2025, while SOC patients attained a mOS of 11.0 months.

(Press release, In8bio, NOV 24, 2025, View Source [SID1234660898])

On November 24, 2025 Phrontline Biopharma ("Phrontline"), a next-generation antibody–drug conjugate (ADC) company, reported the closing of a $60 million Pre-A+ financing round. The round was led by Lapam Investment, with participation from Samsung Venture Investment Corporation (SVIC), Guofang Innovation, Hankang Venture Capital, Songqing Capital, Jifeng Ventures, and Sino Biopharmaceutical Limited. Existing shareholders — Decheng Capital, Medfine Health Fund, and C&D Emerging Investment — also participated and increased their investment in the company. This financing reflects strong investor confidence in Phrontline’s differentiated bispecific and dual-payload ADC platforms, its strategically designed pipeline, and its rapidly expanding global development capabilities. Proceeds will support advancement of the company’s clinical-stage and preclinical ADC programs, expansion of global clinical operations, and strengthening of key strategic partnerships.

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Building a Leading Bispecific and Dual-Payload ADC Platform

Founded in 2022, Phrontline is among the first biotechnology companies globally to focus on bispecific antibody ADCs (BsAb-ADCs) and dual-payload ADCs. The company has built an end-to-end ADC platform spanning antibody discovery, linker–payload engineering, site-specific conjugation, and functional characterization — resulting in a proprietary, highly differentiated technology engine.

Leveraging this platform, Phrontline has designed multiple dual-target combinations and complementary payload strategies tailored to specific tumor indications and has advanced nearly ten innovative ADC programs. Among them, TJ101, a bispecific ADC targeting EGFR and B7-H3, is currently enrolling patients in parallel first-in-human clinical trials in China and the United States. Preclinical data demonstrate superior efficacy and safety relative to peer programs, positioning TJ101 as one of the leading next-generation EGFR/B7-H3 bispecific ADC candidates worldwide.

Strategic Collaborations Accelerating Global Expansion.

On October 20, 2025, Phrontline announced a global strategic collaboration with Samsung Bioepis. Under the terms of the agreement, the companies will jointly develop two next-generation bispecific, dual-payload ADC candidates with differentiated mechanisms of action, leveraging Phrontline’s proprietary BsAb and dual-payload ADC platforms.

On October 31, 2025, Phrontline entered into an exclusive license agreement with Sino Biopharmaceutical Limited for TJ101 in Mainland China and the Hong Kong SAR. Sino Biopharmaceutical will make an upfront payment of an undisclosed amount, along with potential development and commercial milestone payments and sales-based royalties. This collaboration represents a key inflection point for Phrontline’s lead asset as it transitions into accelerated global clinical development.

Advancing Next-Generation ADCs Through Science and Conviction

"From the beginning, our strategy has been guided by biology and translational science. We believe that dual-target synergy and complementary payload mechanisms can unlock new therapeutic options for patients whose tumors are resistant to current therapies," said Tony Chen, Ph.D., Founder and Chief Executive Officer of Phrontline Biopharma. "Our preclinical and emerging clinical data are beginning to validate this vision." "We are deeply grateful to both our new and existing investors for their continued confidence in Phrontline," Dr. Chen added. "This financing marks an important milestone for the company and will allow us to accelerate our clinical programs and global expansion as we work to deliver truly innovative ADC medicines to patients around the world."

Investor Perspective

"Phrontline is a highly execution-focused and resilient team," said Ji Wang, Investment Lead at Lapam Investment. "By leveraging its proprietary bispecific antibody and dual-payload ADC platforms, the company has built a differentiated pipeline aimed at major unmet medical needs. Its preclinical data show compelling efficacy and safety and demonstrate the strong scalability of its platform.

"We look forward to supporting Phrontline as its programs advance through clinical development and as the company continues to drive innovation in next-generation ADC therapeutics," Wang added.

(Press release, Phrontline Biopharma, NOV 24, 2025, View Source [SID1234660914])

On November 24, 2025 Lineage Cell Therapeutics, Inc. reported it had achieved the first milestone available under its worldwide collaboration with Roche and Genentech, a member of the Roche Group, for OpRegen (RG6501), a suspension of human allogeneic retinal pigment epithelial (RPE) cells, currently in development for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). The milestone was achieved based on manufacturing and clinical advancements related to the OpRegen cell therapy program.

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"We are excited to have achieved the first of the $620 million of milestone payments available under our collaboration with Roche and Genentech. The achievement of this milestone is rooted in our manufacturing expertise, which we deployed with the OpRegen cell therapy program, and reflects years of investment to optimize our in-house production processes and highlights the importance of having in-house control of complex manufacturing processes," stated Brian M. Culley, Lineage CEO. "Roche and Genentech are established leaders in ophthalmology, with a demonstrated and longstanding commitment to patients, innovative research, and successful product development, and we are proud to have reached this manufacturing milestone to support the Genentech team’s clinical efforts."

"Long-term clinical outcomes following a single administration of OpRegen cell therapy is challenging the view that GA causes irreversible damage. Clinical data reported at 12-, 24-, and 36-months for Cohort 4 of the Phase 1/2a study (12 patients) continues to demonstrate a consistent and durable treatment effect, with OpRegen-treated eyes exhibiting mean BCVA scores above baseline at each of these timepoints in these patients with less advanced disease. Notably, five patients who received significant coverage of OpRegen cell therapy across their GA lesion are demonstrating long-term outcomes consistent with meaningful disease stabilization and even improvement," added Mr. Culley.

RG6501 (OpRegen) is a suspension of human allogeneic retinal pigment epithelial (RPE) cells currently in development for the treatment of GA secondary to AMD. Subretinal delivery of OpRegen cell therapy has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function. It is being developed under an exclusive worldwide collaboration between Lineage, Roche, and Genentech, a member of the Roche Group, and is currently being evaluated in a Phase 2a clinical study, GAlette, in patients with GA secondary to AMD (ClinicalTrials.gov Identifier: NCT05626114).

(Press release, Lineage Cell Therapeutics, NOV 24, 2025, View Source [SID1234660899])