FibroBiologics Announces Pricing of $4 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

On November 19, 2025 FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics" or the "Company"), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, reported it has entered into a definitive purchase agreement for the issuance and sale to an existing shareholder of 3,540,000 shares of its common stock and pre-funded warrants to purchase 8,570,203 shares of its common stock at a purchase price of $0.3303 per share or pre-funded warrant (less $0.00001 for each pre-funded warrant), in a registered direct offering priced at-the-market under Nasdaq rules. The pre-funded warrants are exercisable at any time at an exercise price of $0.00001 per share and do not expire.

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"We’re grateful for the continued support from one of our major shareholders. Their commitment gives us the flexibility to strengthen our capital structure and stay focused on building the future. This kind of long-term alignment allows us to move faster, innovate more aggressively, and fully pursue the opportunities in our pipeline," said Pete O’Heeron, Founder and Chief Executive Officer.

The purchase price for the shares or prefunded warrants will be paid not in cash but with sovereign-issued .9999 fine gold coins valued at $4,069.18 per oz. based on the spot price of gold at the time of signing of the purchase agreement, delivered to the Company’s depository. The Company intends to liquidate the purchase price into United States dollars in the near term.

In addition, in a concurrent private placement, the Company will issue and sell unregistered warrants to purchase one share of its common stock for each share of common stock or pre-funded warrant purchased in the registered direct offering, for up to 12,110,203 shares of common stock. The unregistered warrants have an exercise price of $0.3303 per share of common stock, will be exercisable beginning on the effective date of, and subject to, approval by our stockholders of the issuance of the shares of common stock upon exercise of the unregistered warrants (the "Stockholder Approval") and will expire five years following the date of the Stockholder Approval. The Company has agreed to file a registration statement with the Securities and Exchange Commission ("SEC") to register the resale of the shares of common stock underlying the unregistered warrants. If at the time of exercise of such warrants there is no effective registration statement registering the shares issuable upon exercise of such warrants, or the prospectus contained therein is not available for the resale of such shares by the warrant holder, then such warrants may also be exercised, in whole or in part, by cashless (net) exercise.

The offering is expected to close on or about November 19, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds to the Company from the offering are expected to be approximately $4.0 million, before deducting offering expenses payable by FibroBiologics. FibroBiologics intends to use the net proceeds from the offering for general corporate purposes, including the satisfaction of debt. In addition, if the holders of the unregistered warrants exercise such warrants in full for cash following the Stockholder Approval, the Company would receive additional gross proceeds of approximately $4.0 million. The Company cannot predict when or if the unregistered warrants will be exercised for cash or exercised at all. It is possible that the unregistered warrants may expire and may never be exercised.

The shares of common stock, pre-funded warrants and shares of common stock issuable upon exercise of the pre-funded warrants offered in the registered direct offering (but not the unregistered warrants issued in the concurrent private placement or the shares issuable upon exercise of such unregistered warrants) are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-284663) previously filed and declared effective by the SEC on February 10, 2025. The offering of the shares of common stock and pre-funded warrants in the registered direct offering is being made only by means of a prospectus supplement that forms a part of the registration statement. The final prospectus supplement relating to the securities offered in the registered direct offering will be filed by FibroBiologics with the SEC. When available, copies of the final prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained from the SEC’s website at www.sec.gov.

The unregistered warrants issued in the concurrent private placement and the shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and/or Regulation D promulgated thereunder, have not been registered under the Act or applicable state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

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

(Press release, FibroBiologics, NOV 19, 2025, View Source [SID1234660083])

Dialectic Therapeutics Announces Dosing of First Patient in Platinum-Resistant Ovarian Cancer (PROC)

On November 19, 2025 Dialectic Therapeutics, Inc., a clinical-stage biotechnology company developing innovative anti-cancer drugs, reported that patient dosing is underway in a clinical trial led by the renowned Drs. Elizabeth Stover, Joyce Liu, and Ursula Matulonis from the Dana-Farber Cancer Institute. Dr. Matulonis previously served as the Principal Investigator for the study that led to a recent FDA approval in platinum-resistant ovarian cancer (PROC).

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Dr. Stover, the principal investigator and IND-holder of the study, has recruited the first two patients, with more now being considered for eligibility in this extraordinarily exciting trial. For more information about the trial, including eligibility criteria, call 877-338-7425 or visit: View Source

"The advance of DT2216 to this Phase 1b/2 trial represents a critical milestone, driven by compelling data from our Phase 1a and preclinical studies. We have a remarkable opportunity to impact patients’ lives and are grateful for the leadership of our world-class collaborators at Harvard and Dana-Farber," said John D. Harkey Jr., Executive Chairman of Dialectic Therapeutics, Inc.

"New therapeutic options are very much needed for our patients with platinum-resistant ovarian cancer. The preclinical data is extremely compelling in terms of the likelihood of translating to the clinical setting, and we are very excited to test weekly paclitaxel and DT2216 for ovarian cancer," stated Dr. Ursula Matulonis, Chief of the Division of Gynecologic Oncology at the Dana-Farber Cancer Institute and professor of Medicine at Harvard Medical School.

Dr. Stover’s trial builds on the Phase 1a clinical data and the preclinical results, generated by Dialectic and Harvard School of Public Health, which demonstrate complete tumor eradication in both in vivo and in vitro ovarian cancer models.

"The preclinical efficacy observed with DT2216 and paclitaxel is among the strongest results we have seen in preclinical models of high-grade serous ovarian cancer. It’s exciting to be able to bring a new potential treatment option to the clinic for our patients," said Dr. Elizabeth Stover, Assistant Professor of Medicine at Harvard Medical School and a medical oncologist in the Division of Gynecologic Oncology.

DT2216 is a novel therapeutic designed to potently and selectively degrade BCL-XL, a key protein used by cancer cells to evade death.

The company’s completed Phase 1a trial enrolled and treated 20 patients across six dose-escalating cohorts. This study established a recommended Phase 2 dose (RP2D) demonstrating a favorable safety and tolerability profile. Biomarkers from patients receiving the RP2D showed that DT2216 degraded the intended BCL-XL target protein in all patients within this dosing cohort, demonstrating powerful and precise target engagement.

In collaboration with Dr. Kristopher Sarosiek at Harvard School of Public Health, the effects of DT2216 were evaluated in cancer cell line and patient-derived xenograft (PDX) models of high-grade serous ovarian carcinoma (HGSOC), including OVCAR3 and the highly chemo-resistant DF83 PDX model. The combination of paclitaxel and DT2216 induced rapid tumor regressions and eradicated the tumors completely. Notably, tumors showed no evidence of regrowth after DT2216 treatment was discontinued.

"As a lab that investigates how tumor cells commit to cell death, we’re encouraged by how cleanly the biology matches the pharmacology. DT2216 selectively engages the target – BCL-XL – and potently initiates tumor cell death in combination with paclitaxel. It’s exactly the trajectory we hope to replicate in patients," stated Dr. Sarosiek, Director of the Cell Death Laboratory at Harvard School of Public Health. "We’ve long sought to develop innovative therapies that directly target the proteins responsible for making tumor cells resistant to treatment, and DT2216 offers us the opportunity to finally achieve this in patients."

(Press release, Dialectic Therapeutics, NOV 19, 2025, View Source [SID1234660100])

Genprex Adds Clinical Trial Site for Acclaim-1 and Acclaim-3 Lung Cancer Clinical Trials

On November 19, 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 Company has added Gabrail Cancer Center in Canton, Ohio, as a new clinical trial site for the Acclaim-1 and Acclaim-3 clinical trials studying its lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), in lung cancer. In addition, the Company expects to add and open additional clinical trial sites for its Acclaim clinical trials over the coming months in an effort to expand its reach to additional patients and expedite enrollment.

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"We are pleased to collaborate with Gabrial Cancer Center, an established patient-focused cancer treatment center, in order to expand the number of trial sites available and to provide access to a greater number of patients who may be able to participate in our lung cancer trials," said Ryan Confer, President and Chief Executive Officer at Genprex. "We believe this partnership may accelerate patient enrollment, allowing more patients to receive our innovative gene therapy treatment and for Genprex to more expeditiously advance our clinical trials."

About Acclaim-1

Acclaim-1 is a Phase 1/2 clinical trial evaluating the combination of REQORSA and AstraZeneca’s Tagrisso (osimertinib) to treat patients with late-stage non-small cell lung cancer (NSCLC) who have activating EGFR mutations and disease progression after treatment with Tagrisso.

The Phase 2a expansion study follows the successful completion of the Phase 1 dose escalation portion of the study, which showed REQORSA was generally well tolerated with no dose limiting toxicities despite doubling the starting dose. Importantly, the results showed early signs of efficacy with some patients experiencing prolonged progression free survival and one patient having a partial response.

The Phase 2a expansion portion of the trial is expected to enroll approximately 33 patients who have previously received Tagrisso treatment and will determine the safety profile and evaluate efficacy, as well as several other exploratory endpoints. Genprex’s team plans to conduct an interim analysis following the treatment of 19 patients, which the Company currently expects to complete enrollment of the first 19 patients in the first half of 2026. The Acclaim-1 clinical trial has received U.S. Food and Drug Administration (FDA) Fast Track Designation.

About Acclaim-3

Acclaim-3 is a Phase 1/2 clinical trial evaluating the combination of REQORSA and Genentech’s Tecentriq (atezolizumab) as maintenance therapy in patients with extensive stage small cell lung cancer (ES-SCLC) who are candidates for maintenance therapy after receiving Tecentriq and chemotherapy as standard of care initial treatment. In this study, patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced.

The Phase 2 expansion study follows the successful completion of the Phase 1 dose escalation portion of the study, which showed REQORSA was generally well tolerated. There were no dose limiting toxicities, and in Acclaim-3, the Phase 2 patients are receiving the same dose of REQORSA as patients in the Phase 2 portion of Acclaim-1.

The Phase 2 expansion portion is expected to enroll approximately 50 patients. The primary endpoint of the Phase 2 portion is to determine the 18-week progression-free survival rate from the time of the start of maintenance therapy with REQORSA and Tecentriq in patients with ES-SCLC. Patients will also be followed for survival. Genprex’s team plans to conduct an interim analysis after the 25th patient enrolled and treated reaches 18 weeks of follow up. The Company expects to complete enrollment of the first 25 patients for interim analysis in the Phase 2 expansion portion of the study in the first half of 2026. The Acclaim-3 clinical trial is supported by FDA Fast Track Designation and Orphan Drug Designation.

(Press release, Genprex, NOV 19, 2025, View Source [SID1234660084])

Nuvalent Announces FDA Acceptance of New Drug Application for Zidesamtinib for the Treatment of TKI Pre-treated Patients with Advanced ROS1-positive NSCLC

On November 19, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for zidesamtinib, an investigational ROS1-selective inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least 1 prior ROS1 tyrosine kinase inhibitor (TKI). The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026.

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Nuvalent’s NDA submission is based on results for TKI pre-treated patients with advanced ROS1-positive NSCLC enrolled in the global registrational ARROS-1 Phase 1/2 clinical trial. These data were reported along with preliminary data from the ongoing Phase 2 TKI-naïve cohort of ARROS-1, and presented as part of the Presidential Symposium at the IASLC 2025 World Conference on Lung Cancer in September 2025.

About Zidesamtinib and the ARROS-1 Phase 1/2 Clinical Trial
Zidesamtinib is an investigational, novel brain-penetrant ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R. In addition, zidesamtinib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy. Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ROS1 tyrosine kinase inhibitors and orphan drug designation for ROS1-positive NSCLC.

Zidesamtinib is currently being investigated in the ARROS-1 trial (NCT05118789), a first-in-human Phase 1/2 clinical trial for patients with advanced ROS1-positive NSCLC and other solid tumors. The completed Phase 1 portion enrolled ROS1-positive NSCLC patients who previously received at least one ROS1 TKI, or patients with other ROS1-positive solid tumors who had been previously treated. The Phase 1 portion of the trial was designed to evaluate the overall safety and tolerability of zidesamtinib, with additional objectives including determination of the recommended Phase 2 dose (RP2D), characterization of the pharmacokinetic profile, and evaluation of preliminary anti-tumor activity. The ongoing global, single arm, open label Phase 2 portion is designed with registrational intent for TKI-naïve and TKI pre-treated patients with advanced ROS1-positive NSCLC.

(Press release, Nuvalent, NOV 19, 2025, View Source [SID1234660101])

GSK and LTZ announce strategic collaboration to advance novel myeloid cell engagers in oncology

On November 19, 2025 GSK plc (LSE/NYSE: GSK) and LTZ Therapeutics (LTZ), an immunotherapy-focused biotechnology company based in Redwood City, California, reported a strategic research collaboration to advance the development of novel myeloid cell engagers (MCEs) to address significant unmet need in oncology. The research collaboration aims to develop up to four potential first-in-class MCE therapies targeting haematologic cancers and solid tumours. The agreement grants GSK an exclusive option to license worldwide development and commercial rights for these pre-clinical therapies.

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MCEs are an emerging class of immuno-oncology treatments designed to use the body’s own immune system to recognise and kill tumour cells, providing a novel approach to target cancers with a favourable safety profile. Myeloid cells make up a significant majority of tissue resident immune cells in the body, providing potential for a broad and sustained infiltration of tumours when they are used to target and kill cancerous cells. The LTZ MCE platform has shown promising pre-clinical data on targeted anti-cancer activity in multiple tumour types. While other modalities have shown efficacy, they can be associated with significant side effects requiring inpatient monitoring that limit community use where most patients receive care.

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK said: "This collaboration builds on GSK’s targeted investment in next-generation technologies to advance cancer medicines with transformative potential. By combining our scientific expertise with LTZ’s innovative immune-engager platform, we aim to accelerate first-in-class myeloid cell engager therapies in haematologic cancers and solid tumours to transform outcomes with a safety profile to enable broad community access for people living with cancer."

Robert Li, Founder and CEO of LTZ said: "We are thrilled to enter a strategic agreement with GSK. This collaboration marks a pivotal milestone in our mission to uncover the potential of myeloid biology to deliver new treatment options for diseases with significant unmet need. Working with GSK for oncology indications will enable us to accelerate this vision, uniting expertise, and a common goal of improving outcomes for patients."

Financial considerations
Under the terms of the agreement, LTZ will receive an upfront payment of $50 million and is eligible to receive success-based preclinical, clinical, regulatory and commercial milestone payments, plus tiered royalties on global net sales of commercialized products resulting from the collaboration.

(Press release, GlaxoSmithKline, NOV 19, 2025, View Source [SID1234660085])