On November 17, 2025 Acuitas Therapeutics, a global leader in lipid nanoparticle (LNP) delivery systems for the acceleration of partners’ clinical development, reported its Next-Generation LNP advancements, a suite of novel and enhanced technologies that expand the range of diseases treatable with mRNA-LNP medicines, at the 13th International mRNA Health Conference in Berlin. Also at the conference, the company highlighted additional preclinical data on its LNP formulations’ applicability in cancer vaccines, potency, and safety.

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"Commercial validation of our technology has provided both an important milestone of success and the impetus for continued advancement," said Dr. Thomas Madden, CEO of Acuitas Therapeutics. "Our research, presented at the mRNA Health Conference, is focused on two key goals: expanding the application of our technology into new therapeutic areas and enhancing the potency and safety of the platform itself, with novel LNP formulations and various improvement strategies. Underpinning both is our commitment to improving the translatability of preclinical data, which is essential for accelerating the journey of mRNA and personalized therapies from the laboratory bench to the clinic."

Next-Generation LNP for mRNA-based Therapeutics

At the conference, Acuitas’ Chief Scientific Officer, Dr. Ying Tam, showcased the company’s Next-Generation LNP advancements, a comprehensive approach that uses multiple technologies and strategies to improve all aspects of LNP utility and applicability – from potency, safety, extrahepatic targeting, to manufacturing.

The advancements were featured in an oral presentation titled "Next-Generation Lipid Nanoparticles for Clinical Development of mRNA-based Therapeutics." The presentation detailed Acuitas’ efforts in advancing mRNA-LNP beyond current clinical standards and broadening the range of diseases these therapies can treat. Key highlights of the presentation include:

Novel LNP candidates engineered for significantly improved potency, as high as a four-fold increase for some cases, in gene editing and vaccine applications.
Optimized lipid structures reduced liver exposure, leading to increased tolerability, lowered liver enzymes, while preserving therapeutic activity in mice.
DARPin-conjugated LNP candidates that achieved highly targeted delivery to immune cells (T-lymphocytes), with a long-circulating format further enhancing uptake efficiency and expression levels.
Mucous penetrant mRNA-LNP candidates capable of extrahepatic delivery to airway epithelial cells in cystic fibrosis lung models, enabling effective gene editing compared to control LNP.
An alternative LNP manufacturing approach, called pre-formed vesicles (PFV), with equivalent potency to standard benchmark manufacturing methods, offered significant improvements in cost, storage, distribution, and flexibility of LNP manufacturing, especially for personalized mRNA-LNP therapies.
Additional Posters Presented

In addition to its lead presentation, Acuitas also showcased three posters that elucidated the mechanics of LNP delivery and assessed its existing slate of lipids, as well as explored novel options for future formulations.

Applying Clinically Approved ALC-315 in Cancer Vaccines

Acuitas’ ALC-315 ionizable lipid — used in the Pfizer-BioNTech COVID-19 vaccine (COMIRNATY) — was assessed for its cancer vaccine development potential. The research directly compared Acuitas’ LNP to lipoplexes and evaluated modified mRNA against the unmodified mRNA predominantly used in current cancer vaccine trials. Key highlights of this data include:

Using LNP comprised of ALC-315, unmodified RNA induced a stronger antigen-specific CD8 T-cell response compared to a nucleoside-modified mRNA incorporating N1methylpseudouridine-encoding OVA payload as a model tumour antigen, while maintaining strong immunogenicity at one-tenth of the initially tested dose.
Using LNP comprised of ALC-315, mRNA delivered intramuscularly induced equal or superior cellular and humoral immunity compared to intravenously (IV) administered mRNA lipoplexes – an alternative mRNA cancer vaccine format in clinical development – despite mRNA lipoplexes being administered at four-fold higher doses and with more boosts.
Several potent novel proprietary lipids were identified that achieved equivalent cellular responses to ALC-315. Further assessment will be conducted to compare potency and activity using syngeneic neoantigen models.
Novel Lipids with Improved Activity for Prophylactic Vaccine Development

Acuitas identified and validated six novel lipids that induce higher virus-specific immunogenicity compared to ALC-315. Key findings related to these novel lipids include:

The six novel lipid candidates induced equivalent neutralizing antibody titres at a five-fold lower dose than ALC-315.
The lipid candidates demonstrated favorable reactogenicity profiles comparable to ALC-315, while eliciting stronger cellular- and B-cell responses.
Innate immune responses induced by LNP correlated with their reactogenicity, but not with adaptive and innate immune responses.
Several lipid candidates achieved higher in vivo expression in secondary lymphoid organs and reduced liver expression compared to ALC-315.
Impact of Body Weight and Medications on mRNA-LNP Safety in Monkeys

As the industry continues using larger nonhuman primates in translational work, Acuitas sought to understand how body weight, premedications (steroid, H1 and H2 blockers), and concomitant medications (meloxicam) impact LNP activity and tolerability. The study was conducted in monkeys using an IV-administered mRNA-LNP encoding human IgG. Key highlights of this data include:

LNP tolerability is reduced in larger monkeys (>6 kg).
Premedications helped reduce the elevation of liver transaminases.
Premedications improved tolerability but reduced the level of IgG mRNA expression.
Platelet count decreases were greatest in large monkeys and monkeys given meloxicam.
More information on posters presented at the mRNA Health Conference and Vaccine R&D Conference can be found here.

(Press release, Acuitas Therapeutics, NOV 17, 2025, View Source [SID1234660039])

On November 17, 2025 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to developing novel therapies to treat cancer, reported the closing of its previously announced private placement in public equity ("PIPE"). The PIPE was led by Ikarian Capital, Squadron Capital Management, Affinity Healthcare Fund, LP, and Exome Asset Management, with participation from other healthcare focused funds, for total gross proceeds of approximately $21.5 million.

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NextCure sold and issued an aggregate of 708,428 shares of common stock ("Common Stock") at the market purchase price of $8.52 per share, and pre-funded warrants ("Pre-Funded Warrants") to purchase up to an aggregate of 1,815,049 shares of Common Stock at a purchase price of $8.519 per Pre-Funded Warrant (each with a nominal exercise price of $0.001 per share for exercise of the warrant) in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act").

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

NextCure intends to use the net proceeds from the offering for general working capital needs, extending the company’s cash runway into the first half of 2027, which is beyond the planned first half of 2026, proof of concept data readouts of its two antibody drug conjugate (ADC) programs, SIM0505 (CDH6 ADC) and LNCB74 (B7-H4 ADC).

The securities sold in the private placement have not been registered under the Securities Act, or any state or other applicable jurisdiction’s securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. In connection with the private placement, NextCure and the investors entered into a registration rights agreement pursuant to which NextCure will file a registration statement (the "Resale Registration Statement") with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the securities sold in the private placement. Any offering of the securities sold in the private placement under the Resale Registration Statement will only be made by means of a prospectus.

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

(Press release, NextCure, NOV 17, 2025, View Source [SID1234660024])

On November 17, 2025 CorriXR Therapeutics, Inc., an oncology-focused biotherapeutics company pioneering a novel gene editing platform to overcome drug resistance in solid tumors, reported the publication of a manuscript in Molecular Therapy Oncology detailing results from a preclinical study evaluating CRISPR-directed gene editing for the treatment of squamous cell lung carcinoma (LUSC). The study was conducted in collaboration with scientists at ChristianaCare’s Gene Editing Institute (GEI).

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"This foundational work strengthens CorriXR’s strategy of disrupting cancer cell survival pathways to restore sensitivity to standard therapies," said Eric B. Kmiec, Ph.D., Founder and Chief Executive Officer of CorriXR Therapeutics and Executive Director of GEI. "These findings build on more than a decade of GEI research into NRF2, a master regulator of cellular stress responses and known driver of treatment resistance. We are encouraged by the consistency of results across in vitro human lung cancer models and our in vivo studies and are actively pursuing IND-enabling work to bring this promising approach to patients."

Key findings from the study include:

Restoration of chemosensitivity: Editing 20-40% of LUSC cells to disrupt NRF2 was sufficient to resensitize tumors to chemotherapy, resulting in significant reductions in tumor growth.
Reduced cancer-driving signals: Edited tumors reduced NRF2 expression and downregulation of its downstream markers, demonstrating effective pathway disruption.
No off-target editing above background: Unintended edits remained below 0.2% supporting the specificity and safety of the gene editing approach.
Strong translational potential: The lipid nanoparticle (LNP) delivery system achieved robust editing in both engineered and patient-derived tumor models, reinforcing the feasibility of advancing towards clinical development.
"Treatment resistance remains one of the greatest challenges in oncology, and these data demonstrate that targeting NRF2 can meaningfully resensitize tumors with minimal off-target effects," said Kelly Banas, Ph.D., lead author of the study and Associate Director of Research at GEI. "This approach has the potential to lower chemotherapy doses, reduce toxicity and help patients remain healthier throughout treatment." Kmiec added, "Instead of creating entirely new drugs, we are using gene editing to make existing ones effective again."

The study also highlights that the biology of NRF2 driven resistance extends beyond lung cancer. "While this work focused on LUSC, NRF2 overactivation drives treatment resistance across multiple solid tumors, including head and neck squamous cell carcinoma (HNSCC)," said Kmiec. "These data indicate that CRISPR-enabled targeting of NRF2 may disrupt the tumor microenvironment and address a shared mechanism of therapeutic failure."

LUSC is an aggressive form of non-small cell lung cancer (NSCLC), representing 20-30% of lung cancer cases and affecting an estimated 190,000 people annually in the U.S. Chemotherapy remains a cornerstone of care, but many patients develop resistance, leaving limited options beyond dose escalation, which increases toxicity and typically worsens quality of life. NRF2 overactivation is a well-established driver of this resistance across multiple solid tumors, including HNSCC, esophageal and liver cancers – representing a significant unmet medical need.

These findings provide a compelling foundation to advance CorriXR’s lead program for HNSCC, as well as the Company’s LUSC program, into clinical development. CorriXR and GEI are now independently validating results at commercial CROs, conducting the required safety and regulatory studies to support an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for approval of human trials, and are exploring partnerships to accelerate clinical translation.

The full publication: Functional characterization of tumor-specific CRISPR-directed gene editing as a combinatorial therapy for the treatment of solid tumors – ScienceDirect is available online in Molecular Therapy Oncology.

(Press release, CorriXR Therapeutics, NOV 17, 2025, View Source [SID1234660040])

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 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])