On November 14, 2025 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and diseases, reported financial results and recent business highlights for its three months ended September 30, 2025.

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The Company anticipates dosing the first patient in a Phase 1 clinical study (NCT07049328) to evaluate HCW9302 in patients with an autoimmune disease in the fourth quarter of 2025. HCW9302 is the Company’s lead product candidate for its clinical program to develop treatments for autoimmune diseases and inflammatory conditions. HCW9302 is a subcutaneously injectable, first-in-kind interleukin 2 ("IL-2") fusion molecule constructed using the Company’s legacy TOBITM platform technology. IL-2, the active component of HCW9302, is the cytokine in humans and other vertebrates responsible for maintaining the proper numbers and functions of regulatory T ("Treg") cells in the body. Treg cells control excessive inflammation caused by other immune cells, which is the etiology of autoimmune diseases. The breakthrough discovery of the critical function of Treg cells by Drs. Mary E. Brunkow, Fred Ramsdell and Shimon Sakaguchi was recently acknowledged with the 2025 Nobel Prize in Physiology or Medicine for their groundbreaking work concerning Treg cells, which discovery was that these cells are the immune system’s security guards which prevent immune cells from attacking our own body.

Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer said, "The goal of our Phase 1 clinical study for HCW9302 is to establish the safe dose that effectively increases Treg cell activity in patients with an autoimmune disease. Once we achieve this objective, we hope to rapidly expand clinical development of HCW9302 in Phase 2 studies in patients with alopecia areata as well as other autoimmune diseases and inflammatory conditions."

Business Highlights

Business Development Transactions

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The Company has launched its search for a strong commercial partner for the clinical development of its T-cell engager ("TCE") compounds. These compounds are designed to address shortfalls in the first generation products. The Company has created TCE compounds that can target cancer antigens and CD3 activation of effector T cells while simultaneously reducing the immunosuppression in tumor microenvironment. Such immunosuppression could play a pivotal role in reducing effector T-cell infiltration and anti-tumor efficacy in solid tumors.

Financing Transactions

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During the three months ended September 30, 2025, the Company issued 475,000 shares of Common Stock for gross proceeds of $2.2 million utilizing the Company’s Standby Equity Purchase Agreement.

Preclinical and Clinical Development Results

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The Company has successfully opened two clinical sites that are actively screening patients to participate in a first-in-human Phase 1 dose escalation clinical trial to evaluate one of its lead drug candidates, HCW9302, in patients with alopecia areata. The Company expects to dose the first patient in this clinical trial in the fourth quarter of 2025. Alopecia areata is a common autoimmune disease in humans that currently has no curative FDA approved treatments. It causes sudden hair loss and can have a significant negative impact on patients’ quality of life and psychological health. The National Alopecia Areata Foundation estimates approximately 160 million people worldwide and 7 million people in the United States have alopecia areata. The condition affects about 2% of the global population at some point in their lifetime.
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HCW Biologics showcased data for its lead engager HCW11-018b highlighting the uniqueness and advantages of the Company’s second-generation TCE program over the first-generation products at SITC (Free SITC Whitepaper). HCW11-018b is a tetra-valent construct that activates tumor-infiltrated exhausted T cells while addressing the immunosuppressive tumor microenvironment. It has broad coverage for human solid tumor indications by targeting tissue factor, with high potency and precision, shown in xenograft models including the Patient-Derived Xenograft (PDX) tumor model.

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HCW Biologics also presented data for its lead product candidate in the Company’s second-generation immune checkpoint inhibitor program at SITC (Free SITC Whitepaper). HCW11-040 is a proprietary TRBC-pembrolizumab-based immune checkpoint inhibitor, which the Company considers as its franchise immunotherapeutic compound for internal clinical development. It is a unique combination of cytokines in multi-functional fusion protein molecule that exhibits the ability to expand progenitor exhausted T cells, or TPEX cells, without inducing a cytokine storm in preclinical studies. TPEX cells, located in the draining lymph nodes and tumors of the patients, have been implicated as the primary responders to ICI therapy. HCW11-040 in undergoing IND-enabling studies to prepare for clinical trials for evaluation in the treatment of solid tumors.

Third Quarter 2025 Financial Results

Revenues: Revenues for the three months ended September 30, 2024 and 2025 were $426,423 and $15,606, respectively. Revenues for the nine months ended September 30, 2024 and 2025 were $2.2 million and $27,222, respectively. Historically, revenues have been derived exclusively from the sale of licensed molecules to the Company’s licensee, Wugen. In the nine months ended September 30, 2025, the Company agreed to a one-year suspension of the Wugen License Agreement.

Research and development (R&D) expenses: R&D expenses for the three months ended September 30, 2024 and 2025 were $1.2 million and $1.4 million, respectively, an increase of $271,334, or 18%. R&D expenses for the nine months ended September 30, 2024 and 2025 were $5.3 million and $4.1 million, respectively, a decrease of $1.2 million, or 23%. R&D expenses in the nine months ended September 30, 2024 were comparatively higher than the same period in 2025 due to expenses incurred for the manufacture of a high-expressing line of HCW9101, an element needed in the manufacture of HCW9302, the Company’s clinical-stage molecule. Such activities were completed in 2024.

General and administrative (G&A) expenses: G&A expenses for the three months ended September 30, 2024 and 2025 were $1.6 million and $1.9 million, respectively, an increase of $251,537, or 15%. G&A expenses for the nine months ended September 30, 2024 and 2025 were $4.8 million and $6.2 million, respectively, an increase of $1.4 million, or 29%. The increase in G&A expenses in 2025 was primarily due to salaries and benefits and professional fees related to audit services, tax and other advisory services, as well as required activities to remain in compliance with SEC regulations and Nasdaq listing rules.

Legal expenses (recoveries), net: Legal expenses and recoveries, net represent the legal fees that the Company incurred for an Arbitration which held its hearing in May 2024, was settled on July 13, 2024, and was dismissed on December 24, 2024. Legal expenses (recoveries), net for the three months ended September 30, 2024 and 2025 were $1.0 million and $6,006, respectively. Legal expenses (recoveries), net for the nine months ended September 30,2024 and 2025 were $15.8 million and a contra expense of ($1.6) million, respectively. In January 2025, the Company received a $2.0 million insurance reimbursement that was paid directly to the law firm involved in representing Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, in the Arbitration. The Company is engaged in discussions with the law firms involved with this matter to arrange a reasonable payment plan with respect to $12.1 million legal fees which remain unpaid.

Net loss: Net loss for the three months ended September 30, 2024 and 2025 was $3.9 million and $4.6 million, respectively. Net loss for the nine months ended September 30, 2024 and 2025 was $26.7 million and $8.7 million, respectively.

(Press release, HCW Biologics, NOV 14, 2025, View Source [SID1234659970])

On November 14, 2025 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager TriKE platform, reported third quarter 2025 financial results for the period ended September 30, 2025.

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The Company’s Phase 1 dose escalation study is evaluating GTB-3650 in a total of 14 patients (two patients per cohort) with relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including refractory acute myeloid leukemia and high-risk myelodysplastic syndrome. GTB-3650 is dosed in two-week blocks, two weeks on and two weeks off, for up to four months based on clinical benefit. The trial aims to assess the safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity. The Company plans to provide the next update on the trial in the first quarter of 2026 following completion of additional dose cohorts.

"We are highly encouraged by the continued progress of our Phase 1 clinical trial evaluating GTB-3650 in cancer patients, which has now advanced to Cohort 4 at a dose level of 10 µg/kg/day ," said Michael Breen, Executive Chairman and Chief Executive Officer. "We look forward to assessing higher doses, as we are now approaching the efficacy range predicted by preclinical in vivo leukemia models, and we plan to share the next trial update in the first quarter of 2026. The excellent safety profile observed with GTB-3650 and the immune activation potential of bringing IL-15 to the immune synapse suggests a potential competitive advantage for GTB-5550 compared to other modalities like bispecific antibodies, cell therapies, and antibody drug conjugates also targeting solid tumors expressing B7H3, which is quicky emerging as a compelling novel immune checkpoint target."

Third Quarter 2025 Financial Summary

Cash Position: The Company had cash and cash equivalents of approximately $2.6 million as of September 30, 2025, which is anticipated to be sufficient to fund the Company’s operations into the first quarter of 2026.

Research and Development (R&D) Expenses: R&D expenses for the third quarter ended September 30, 2025 were approximately $0.6 million compared to $1.3 million for the same comparable quarter of 2024. The $0.7 million decrease was primarily due to a reduction in production and material costs. R&D expenses primarily relate to the Company’s continued licensing, development and production of its most advanced TriKE product candidates GTB-3650 and GTB-5550 along with the progression on other promising product candidates. In late June 2024, the Company received clearance from the Food and Drug Administration with respect to the Company’s Investigational New Drug ("IND") application in relation to the Company’s next generation GTB-3650 camelid nanobody product. Study enrollment began in early 2025 and the Company has advanced into the clinic, enrolling patients, and performing tests for data collection throughout the year. Following the financing completed in May 2025, the Company has restarted the final phase of product development of GTB-5550 and anticipates submission of an IND application for GTB-5550 in late December 2025 or in January 2026.

Selling, General and Administrative (SG&A) Expenses (Excluding Stock Compensation): SG&A expenses for the third quarter ended September 30, 2025 were relatively flat compared to the same comparable quarter of 2024, amounting to approximately $2.4 million compared to $2.3 million, respectively.

Net Loss: The Company reported a net loss of approximately $3.1 million for the third quarter ended September 30, 2025 compared to a net loss of $3.4 million for the same comparable quarter in 2024. The $0.3 million decrease consisted primarily of significant decreases in R&D expenses (as described above).

(Press release, GT Biopharma, NOV 14, 2025, View Source [SID1234659969])

On November 14, 2025 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty income, reported financial results and recent corporate highlights for the third quarter ended September 30, 2025.

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Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, "Fortress has achieved several strategic milestones that reinforce the strength of our diversified business model and our continued ability to enhance shareholder value across our portfolio. The acquisition of two subsidiaries this year, Checkpoint Therapeutics, Inc. ("Checkpoint"), by Sun Pharma and Baergic Bio, Inc. ("Baergic") by Axsome Therapeutics ("Axsome"), are both strategic exits that represent validation of our approach. The sale of Checkpoint generated approximately $28 million in upfront consideration, with the potential for additional contingent value right (CVR) payments and future royalty income from sales of UNLOXCYT (cosibelimab-ipdl) to Fortress. We also anticipate the resubmission of the New Drug Application ("NDA") for CUTX-101, which, upon approval, may qualify for a Priority Review Voucher—further demonstrating the potential embedded value in our pipeline. Journey Medical Corporation ("Journey Medical") continues to deliver strong operational execution, highlighted by the successful launch of Emrosi and accelerating commercial performance, supported by expanded payer coverage and new pooled Phase 3 data analysis presented at Fall Clinical demonstrating Emrosi’s statistical and clinical superiority over Oracea and placebo for the treatment of rosacea. Additionally, our late-stage pipeline continues to progress meaningfully, with dotinurad advancing in two Phase 3 trials for the treatment of gout. The $205 million Series A financing announced by Crystalys Therapeutics, Inc. ("Crystalys") underscores the market’s confidence in dotinurad’s best-in-class potential for safety and efficacy. Urica Therapeutics’ ("Urica") strategic sale of dotinurad to Crystalys last year, in exchange for equity and a 3% royalty on future net sales, further positions Fortress to participate in long-term value creation. As we move forward, Fortress remains focused on disciplined execution, optimizing our capital allocation, and advancing high-impact assets that drive sustainable growth and deliver innovative treatments to patients worldwide."

Recent Corporate Highlights1:

Monetization Updates

● In November 2025, Avenue Therapeutics, Inc. ("Avenue") announced the acquisition of its subsidiary Baergic by Axsome. Under the terms of the purchase agreement, Baergic shareholders will receive a $0.3 million upfront payment (less transaction expenses) and are eligible to receive milestone payments of up to $2.5 million upon the occurrence of certain development and regulatory events for the first indication for AXS-17 (formerly known as BAER-101) and $1.5 million for each indication thereafter, up to $79 million in potential sales-based milestones, and a tiered mid-to-high single-digit royalty on potential global net sales of AXS-17. Avenue is eligible to receive ~74% of all future payments and royalties payable under the agreement. Avenue is a subsidiary of Fortress.
● In May 2025, Fortress’ subsidiary, Checkpoint, was acquired by Sun Pharmaceutical Industries, Inc. (together with its subsidiaries and/or associated companies, "Sun Pharma"). Checkpoint was acquired for an aggregate upfront payment totaling ~$355 million and ~$60 million payable in a CVR, of which Fortress received approximately $28 million upfront, with the potential for an additional CVR payment of up to $4.8 million and a 2.5% royalty on future net sales of UNLOXCYT (cosibelimab-ipdl) to Fortress.

Clinical Updates

● In October 2025, the first patients were dosed in two randomized, double-blind, multicenter global Phase 3 trials evaluating dotinurad, a next-generation, once daily oral, URAT1 inhibitor with potential for best-in-class safety and efficacy for the treatment of gout.
● Also in October 2025, we presented efficacy data from a pooled analysis of the two Phase 3 multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, Minocycline Versus Oracea in Rosacea-1 and Minocycline Versus Oracea in Rosacea-2, evaluating DFD-29 (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) (or "Emrosi") for the treatment of inflammatory lesions of rosacea in adults, at the 2025 Fall Clinical Dermatology Conference. DFD-29 demonstrated superior efficacy in Investigator’s Global Assessment ("IGA") treatment success rates and inflammatory lesion counts versus both placebo and doxycycline (P<0.001 for all comparisons).
● In July 2025, AstraZeneca announced that anselamimab (formerly known as CAEL-101) did not achieve statistical significance for the primary endpoint in its Phase III Cardiac Amyloid Reaching for Extended Survival ("CARES") clinical program for Mayo stages IIIa and IIIb AL amyloidosis patients. However, the drug showed clinically meaningful improvement in a prespecified subgroup and was well tolerated. AstraZeneca indicated that the company plans to submit the prespecified subgroup analysis from the CARES trials with regulatory authorities.

Regulatory Updates

● In December 2023, we completed the asset transfer of CUTX-101 to Sentynl Therapeutics ("Sentynl"), a wholly owned subsidiary of Zydus Lifesciences Ltd. Pursuant to the transaction with Sentynl, Sentynl will transfer to Cyprium, if issued upon approval, a Rare Pediatric Disease Priority Review Voucher ("PRV"), and Cyprium will also be eligible to receive royalties on net sales of CUTX-101 and up to $129 million in aggregate development and sales milestones from Sentynl. On September 30, 2025, the FDA issued a Complete Response Letter ("CRL") relating to the NDA for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients. The CRL noted cGMP deficiencies had been observed at the facility where CUTX-101 is manufactured, and Sentynl expects to resubmit the CUTX-101 NDA shortly. The CRL did not cite any other approvability concerns, nor did it identify any deficiencies in CUTX-101’s efficacy and safety data.

● In July 2025, the FDA granted Orphan Drug Designation to Mustang Bio, Inc. ("Mustang Bio") for MB-101 (IL13Ra2-targeted CAR T-cells) for the treatment of recurrent diffuse and anaplastic astrocytoma and glioblastoma. MB-101 received Orphan Drug Designation on time and with a designation that is broader than the indication proposed. We intend to advance MB-101, in combination with MB-108, as a potential treatment option. Our novel therapeutic strategy, combining our MB-101 CAR-T cell therapy with our MB-108 oncolytic virus, leverages MB-108 to reshape the tumor microenvironment ("TME") to make cold tumors "hot," thereby potentially improving the efficacy of MB-101 CAR-T cell therapy.

Commercial Product Updates

● Journey Medical’s net product revenues for the third quarter ended September 30, 2025, were $17.0 million, compared to net product revenues of $14.6 million for the third quarter ended September 30, 2024.
● In July 2025, Journey Medical announced expanded payer access with over 100 million commercial lives in the United States for Emrosi (40mg Minocycline Hydrochloride Modified-Release Capsules, 10mg immediate release and 30mg extended release), the Company’s recently launched treatment for the inflammatory lesions of rosacea in adults. This compares to 54 million commercial lives in May 2025.

General Corporate:

● In the third quarter of 2025, Crystalys, in which Urica Therapeutics, Inc. ("Urica") maintains an equity position, announced a $205 million Series A financing to support the advancement of global Phase 3 clinical studies evaluating dotinurad for the treatment of gout. In addition, Urica is eligible to receive a 3% royalty on future net sales of dotinurad. Urica is a majority-owned and controlled subsidiary of Fortress.

Financial Results:

● As of September 30, 2025, Fortress’ consolidated cash and cash equivalents totaled $86.2 million, compared to $57.3 million as of December 31, 2024, an increase of $28.9 million year-to-date.
● Fortress’ consolidated cash and cash equivalents, totaling $86.2 million as of September 30, 2025, includes $38.6 million attributable to Fortress and the private subsidiaries, $3.7 million attributable to Avenue, $19.0 million attributable to Mustang Bio and $24.9 million attributable to Journey Medical.
o Fortress’ consolidated cash and cash equivalents totaled $57.3 million as of December 31, 2024, and included $20.9 million attributable to Fortress and private subsidiaries, $2.6 million attributable to Avenue, $6.6 million attributable to Checkpoint, $6.8 million attributable to Mustang Bio and $20.3 million attributable to Journey Medical. Checkpoint was acquired by Sun Pharma in May 2025.
● Fortress’ consolidated net revenue totaled $17.6 million for the third quarter ended September 30, 2025, $17.0 million of which was generated from our marketed dermatology products. This compares to consolidated net revenue totaling $14.6 million for the third quarter of 2024, all of which was generated from our marketed dermatology products.
● Consolidated research and development expenses totaled $0.2 million for the third quarter ended September 30, 2025, compared to $9.4 million for the third quarter ended September 30, 2024.
● Consolidated selling, general and administrative costs were $17.4 million for the third quarter ended September 30, 2025, compared to $22.0 million for the third quarter ended September 30, 2024.
● Consolidated net income attributable to common stockholders was $3.7 million, or $0.13 per share basic, and $0.11 per share diluted, for the third quarter ended September 30, 2025, compared to net loss attributable to common stockholders of $(15.0) million, or $(0.76) per share basic and diluted, for the third quarter ended September 30, 2024.

(Press release, Fortress Biotech, NOV 14, 2025, View Source [SID1234659968])

On November 14, 2025 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, reported that Curis will report emavusertib and BTKi clinical data in Primary CNS Lymphoma (PCNSL) and Secondary CNS Lymphoma (SCNSL) in three presentations and preclinical data on emavusertib in an oral presentation at the 30th Annual Meeting of the Society for Neuro-Oncology (SNO) on November 19-23:

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November 21, 2025 – 4:30 PM ET (11:30 AM HT)

Format:

Poster Presentation

Presenter:

Dr. Christian Grommes, Memorial Sloan Kettering Cancer Center, NY, NY

Title:

Analysis of Genetic Mutation Profile and CNS Pharmacokinetics in Relapsed/Refractory Primary CNS Lymphoma Patients Responding to Novel Emavusertib (IRAK4i) and BTKi Combination

Format:

Poster Presentation

Presenter:

Dr. Lakshmi Nayak, Dana-Farber Cancer Institute, Boston, MA

Title:

Preliminary Safety and Efficacy of Emavusertib (CA-4948) in Combination with Ibrutinib in Relapsed/Refractory Primary Central Nervous System Lymphoma Patients

November 22, 2025 – 4:45 PM ET (11:45 AM HT)

Format:

Rapid Oral Presentation

Presenter:

Dr. Christian Grommes, Memorial Sloan Kettering Cancer Center, NY, NY

Title:

Analysis of Genetic Mutation Profile and CNS Pharmacokinetics in Relapsed/Refractory Primary CNS Lymphoma Patients Responding to Novel Emavusertib (IRAK4i) and BTKi Combination

Format:

Poster Presentation

Presenter:

Cecilia A. Merrigan, APRN, CNP, DNP, Mayo Clinic, Rochester, MN

Title:

Promising Efficacy Signal in Secondary CNS Lymphoma Patients Treated with Emavusertib and Ibrutinib

November 23, 2025 – 3:24 PM ET (10:24 AM HT)

Format:

Oral Presentation

Presenter:

Christina von Roemeling, Ph.D., University of Florida, Gainesville, FL

Title:

Targeting Myddosome Signaling to Improve Immunotherapy in Melanoma Brain Metastases

(Press release, Curis, NOV 14, 2025, View Source [SID1234659967])

On November 14, 2025 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported its participation in the Jefferies Global Healthcare Conference in London on Wednesday, November 19, 2025 at 11:30 a.m. GMT (6:30 a.m. ET).

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A live webcast will be available on the Investors & Media page of Cogent’s website at investors.cogentbio.com. A replay of the webcast will be available approximately two hours after the completion of the event and will be archived for up to 30 days.

(Press release, Cogent Biosciences, NOV 14, 2025, View Source [SID1234659966])