On March 17, 2026 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported financial results for the full year of 2025 and recent operational progress.

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"2026 is about building a steady cadence of biopsies and treatments," said Vish Seshadri, Chief Executive Officer of Abeona. "We are focused on ensuring every ZEVASKYN patient has a seamless experience throughout their treatment journey. Establishing these commercial foundations will position us to scale-up ZEVASKYN in 2026 and beyond."

ZEVASKYN (prademagene zamikeracel) updates

● First ZEVASKYN commercial patient treatment completed in December; launch momentum building in first quarter 2026: Following the optimization of a release assay in 2025, ZEVASKYN commercial launch activities commenced in the fourth quarter, with the first patient treatment completed in December prior to a mandatory annual manufacturing facility shutdown. Since resuming manufacturing in late January 2026, multiple biopsies have been collected with additional biopsies expected this month. One patient has completed treatment with ZEVASKYN so far in 2026, and other collected biopsies are at various stages in the manufacturing process.
● Growing ZEVASKYN treatment experience expected to catalyze further ZEVASKYN demand: Growing ZEVASKYN treatment experience across the initial Qualified Treatment Center (QTC) network is establishing the institutional workflows and scalable foundation necessary to accelerate patient throughput and streamline the referral-to-treatment timeline. As the RDEB community shares in the positive experiences of the initial ZEVASKYN patients, the Company believes this will continue to catalyze sustained demand for ZEVASKYN.
● Abeona expands patient access to ZEVASKYN across Texas and the Gulf Coast region with activation of its newest QTC: In December, the Company announced activation of The University of Texas Medical Branch (UTMB), in Galveston, Texas, as the fourth QTC for ZEVASKYN. UTMB is a major academic medical center renowned for its expertise in comprehensive complex skin disease and wound care.

Full Year 2025 Financial Results

Abeona reported total revenue of $5.8 million for the year ended December 31, 2025. This was comprised of $3.4 million in license and other revenues and $2.4 million in net product revenue. License and other revenues were driven by a clinical milestone reached under the October 2020 sublicense agreement with Taysha Gene Therapies for its investigational Rett syndrome gene therapy.

Net product revenue reflects the single patient treatment in December. While net product revenue reflects Medicaid coverage for the patient treated in December, the Company expects average net revenues to normalize over time as the payer mix expands to include commercially insured patients. Cash was received from the December treatment in the first quarter 2026.

Cost of sales for 2025 was $1.5 million, primarily driven by the first commercial ZEVASKYN treatment in December and costs from an August production batch that was not released due to technical challenges related to the FDA-mandated rapid sterility lot release assay.

Total research and development (R&D) spending for 2025 decreased $7.6 million to $26.8 million, compared to $34.4 million in 2024. This reduction was primarily driven by the April 2025 FDA approval of ZEVASKYN, which resulted in certain production costs being capitalized into inventory and engineering runs that are no longer classified as R&D expense.

Selling, general and administrative (SG&A) expenses for 2025 were $65.0 million, an increase of $35.1 million over 2024. This increase primarily reflects Abeona’s commercial transition following the April 2025 FDA approval of ZEVASKYN, including $18.6 million in personnel and stock-based compensation and $2.3 million in direct commercialization costs. Additionally, certain engineering and training expenses previously classified as R&D were transitioned to SG&A post-approval.

In May 2025, Abeona sold the Rare Pediatric Disease Priority Review Voucher (PRV) awarded following the FDA’s approval of ZEVASKYN. The Company received $155.0 million in gross proceeds from the sale in June 2025, resulting in a $152.4 million gain net of $2.6 million in transaction costs.

Net income was $71.2 million for the year ended December 31, 2025, or $1.34 per basic and $1.01 per diluted common share. Net loss in 2024 was $(63.7) million, or $(1.55) per basic and diluted common share.

Cash, cash equivalents and short-term investments totaled $191.4 million as of December 31, 2025.

Conference Call Details

The Company will host a conference call and webcast on Tuesday, March 17, 2026 at 8:30 a.m. ET to discuss its 2025 financial results and corporate progress. To access the call, dial 888-506-0062 (U.S. toll-free) or 973-528-0011 (international) and Entry Code: 977217 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona’s website at View Source The archived webcast replay will be available for 30 days following the call.

(Press release, Abeona Therapeutics, MAR 17, 2026, View Source [SID1234663604])

On March 17, 2026 Prescient Therapeutics Ltd (ASX:PTX) is advancing enrolment in its Phase 2 clinical trial for lead asset PTX-100, with new research highlighting steady progress across trial execution, regulatory milestones and funding — while pointing to valuation upside from current levels.

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A new report from Pitt Street Research outlines growing momentum behind PTX-100, a first-in-class oncology drug targeting relapsed or refractory cutaneous T-cell lymphoma (CTCL), a rare and difficult-to-treat cancer where treatment options remain limited.

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The therapy works by inhibiting GGTase-1, a pathway involved in cancer cell signalling and survival, offering a differentiated approach compared with existing treatment classes.

Phase 2 footprint expands
The Pitt Street report noted that Prescient’s Phase 2 trial continues to scale, with eight of a planned 16 global sites now established and enrolling patients.

The study is structured in two stages, beginning with dose optimisation before expanding into a broader efficacy and safety phase. Key endpoints include objective response rate, along with progression-free survival and duration of response.

Clinical sites across the US and Australia are already active, with European expansion underway — a key step expected to support recruitment in a relatively small and specialised patient population.

The report highlights European site activation as a critical near-term driver, particularly as new investigators come on board to help lift enrolment rates and accelerate data flow through 2026.

Early data supports differentiated approach
While Phase 2 remains in its early stages, the investment case continues to be anchored by encouraging Phase 1 results.

PTX-100 delivered a 43% overall response rate and a 100% clinical benefit rate in earlier studies, alongside a favourable safety profile with no serious adverse events attributed to the drug.

That combination is particularly relevant in CTCL, where existing therapies often struggle to deliver durable responses without significant side effects.

The research note argues the drug’s unique mechanism and early data position it as a potentially differentiated option in this setting, while also opening the door to broader applications across other cancers.

"PTX-100’s status as the only GGTase-1 inhibitor in clinical development anywhere in the world, and one with far more promising results than any TCL drugs on the market, gives it a uniqueness that is attractive to potential pharmaceutical partners."

Regulatory progress and funding support
Recent regulatory milestones are also strengthening the commercial outlook.

PTX-100 has secured orphan drug designation in both the US and Europe for CTCL, providing incentives such as market exclusivity, regulatory support and reduced fees — factors that can help streamline development and improve long-term economics.

Prescient has also reinforced its balance sheet, raising $9.8 million in capital and receiving a $4.3 million R&D tax incentive refund, extending its cash runway into 2027.

This funding position supports continued clinical progress while allowing the company to explore potential partnering opportunities.

Partnerships and broader pipeline optionality
Beyond PTX-100, the report points to additional upside from Prescient’s pipeline, including its OmniCAR and CellPryme platforms.

These technologies are designed to enhance cell therapy approaches such as CAR-T, addressing limitations around durability, efficacy and control. The company is currently seeking collaborations to advance these programmes, creating additional pathways for value creation.

However, the most significant near-term catalyst remains PTX-100, particularly as Phase 2 data begins to build.

"A pharma partnership — whether in the form of a co-development agreement, regional licensing deal, or broader collaboration — would be a transformative catalyst for Prescient’s valuation and share price."

The report notes that meaningful Phase 2 data will likely be required before major deals are struck, although early engagement with potential partners is already under way.

Valuation highlights upside, with risks in focus
Pitt Street Research has reiterated its valuation range of $0.11 to $0.16 per share, based on a risk-adjusted net present value model incorporating PTX-100, CellPryme and the company’s cash position.

PTX-100 accounts for the majority of that valuation, reflecting its position as the company’s lead and most advanced asset.

At current levels around $0.06 per share, the report implies material upside, contingent on continued clinical progress and successful execution of the Phase 2 programme.

As with all clinical-stage biotech companies, risks remain. Pitt Street notes that for Prescient, these include potential delays in patient enrolment, regulatory uncertainty and the possibility of future capital requirements, alongside the inherent variability of clinical outcomes as trials expand.

According to the researchers, with Prescient’s differentiated mechanism, supportive early data and expanding trial infrastructure, the company is entering a critical period where execution — particularly around enrolment and data delivery — will be key to unlocking that potential.

On March 17, 2026 Alloy Therapeutics, Inc. ("Alloy"), a biotechnology ecosystem company dedicated to democratizing access to cutting-edge drug discovery technologies, reported an agreement with AbbVie to develop a new antibody platform to discover potent, specific, and effective antibodies against targets that are difficult to address with current technologies. As part of the multi-year agreement, Alloy will receive an upfront payment, as well as an additional payment in connection with the delivery of the platform to AbbVie.

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The collaboration provides AbbVie with access to the antibody discovery platform as part of its broader research efforts. For Alloy, the collaboration reflects its continued focus on enabling partners through platform-based discovery technologies and reinforces its commitment to advancing antibody therapeutics.

Alloy’s ATX-Gx platform has rapidly become the industry standard for fully humanized transgenic mice, and is now used by over 200 partners to enable many therapeutic discovery programs. Alloy is dedicated to reinvesting its revenue into innovation and has continuously expanded its platform offerings, developing new strains and tools to meet the evolving needs of antibody discovery. This commitment ensures Alloy remains at the forefront of enabling partners to access advanced technologies that accelerate drug development.

"We believe the best technologies are built in close collaboration with partners who share our commitment to innovation and real-world impact," said Davide Schiavone, Senior Director and Head of Genetically Engineered Organisms at Alloy Therapeutics. "This agreement with AbbVie allows us to design a platform that reflects what scientists truly need with practical, modular tools that streamline therapeutic discovery and expand what’s possible in antibody engineering."

(Press release, Alloy Therapeutics, MAR 17, 2026, View Source [SID1234663579])

On March 17, 2026 Soley Therapeutics, a biotechnology company advancing novel therapeutics informed by integrated cell stress biology, reported STX-6398, a first-in-class drug candidate with selective anti-tumor activity through modulation of cytoskeleton-associated protein 2 (CKAP2), a previously undruggable protein central to malignant cancer progression. Preclinical data for STX-6398 will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place April 17-22 in San Diego.

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The AACR (Free AACR Whitepaper) presentation will describe the discovery and preclinical characterization of STX-6398, an oral small molecule that modulates CKAP2 and its downstream signaling pathways. Studies demonstrate selective anti-tumor activity in vitro and in vivo, with efficacy observed across preclinical models following oral administration. These data support advancing STX-6398 as a new therapeutic opportunity for CKAP2-expressing cancers.

"CKAP2 sits at the intersection of microtubule dynamics and malignant progression, shaping proliferation, migration, and angiogenesis," said Yerem Yeghiazarians, M.D., Co-Founder and Chief Executive Officer of Soley Therapeutics. "The data to be presented at AACR (Free AACR Whitepaper) demonstrate that it is possible to pharmacologically modulate CKAP2 with an oral small molecule and achieve meaningful anti-tumor activity across multiple preclinical models. STX-6398 is one of many first-in-class candidates from Soley’s integrated cell stress platform and validates that our approach can enable drugging targets long considered inaccessible."

Soley’s AACR (Free AACR Whitepaper) 2026 Presentation Details

Title: CKAP2 Modulation with a Novel Small Molecule Results in Excellent In-Vitro and In-Vivo Anti-Tumor Activity
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Targets and Pathways
Day and Time: April 20, 2:00 PM to 5:00 PM PDT
Location: Poster Section 15
Poster Number: 3043

(Press release, Soley Therapeutics, MAR 17, 2026, View Source [SID1234663575])

On March 16, 2026 HCW Biologics Inc. ("HCWB" or the "Company") (NASDAQ: HCWB), is a U.S.-based commercial- and clinical-stage biopharmaceutical company focused on supporting or developing novel immunotherapies to treat autoimmune diseases, cancer, and senescence-associated dysplasia, reported results of groundbreaking research studies, published in the peer-reviewed, high-impact journal, Science Advances (Cole et al., "IL-7/IL-15/IL-21 cytokine-fusion scaffold generates highly functional CAR-T cells enriched in long-lived T memory stem cells" Science Advances, 13 Mar 2026, Vol 12, Issue 11). These studies were led by Harris Goldstein, M.D., professor of pediatrics and of microbiology & immunology and director of the Einstein-Rockefeller-CUNY-Mount Sinai Center for AIDS Research and his team of Albert Einstein College of Medicine scientists, most notably Erin Cole, M.S., a graduate student in the Goldstein laboratory.

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The study results demonstrated that HCW9206, the Company’s proprietary and commercial-stage multi-cytokine fusion protein reagent, provides a revolutionary approach to generate chimeric T-cell receptor – T cells ("CAR-Ts") for immunotherapy with increased function in a cost-effective manner. HCW9206, a first-in-class cytokine-scaffold-based platform, enables production of more potent CAR-T-based immunotherapies by generating a CAR-T population which is highly functional and markedly enriched for long-live T-memory stem cells (Tscm). Utilizing HCW9206 as a manufacturing strategy may be broadly applicable to increase persistence and functionality of CAR-Ts.

Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, stated, "HCW9206 is a novel compound that enables a single molecule to deliver synergistic signals from three different immune-stimulatory cytokines. It is versatile and has shown activity in the creation of memory-like NK-cells for cell-based therapy against cancer, and now we also discovered it has the potential to enhance the production of CAR-T therapies as a promising novel reagent to replace the current industry-standard method that relies on anti-CD3/anti-CD28/IL-2-based approaches. An approach that employs HCW9206 as a reagent is more streamlined and may lower the cost of CAR-T manufacturing. Equally important, based on experimental models, HCW9206 has shown improvement in functional activities and persistence of CAR-Ts following adoptive transfer, a goal the industry has been trying to achieve for the last decade."

Functional persistence of CAR-Ts is limited by conventional and costly manufacturing methods utilizing anti-CD3/CD28 (αCD3/28)/IL-2 stimulation, which generates terminally differentiated and shorter-lived CAR-Ts. Utilizing HCW9206 during the manufacture of CAR-Ts synergizes the effects of IL-7, IL-15 and IL-21 to promote the generation of a CAR-T cell product with a diverse mix of T cell subsets that exhibit a combination of Tscm self-renewal capacity and enhanced T cell effector function, likely from the TEM population. In this pivotal publication, the authors show how HCW9206, when used in the manufacture of CAR-T, stimulates proliferation of CD8+T cells, particularly those within the Tscm subset. As a result, HCW9206 was shown to generate CAR-Ts without requiring αCD3/28/IL-2 activation which are highly enriched in long-lived Tscm (50% or more) and display potent activity across distinct disease experimental models, namely, HIV-1 or B-cell leukemia. In preclinical studies, CAR-Ts manufactured using HCW9206 were significantly superior compared to CART-Ts manufactured using standard methods employing anti-CD3/anti-CD28 and IL-2 reagents for CAR lentiviral transduction and subsequent expansion and persistence of highly active human CAR-Ts. While there is still a need to confirm in clinical studies, this research suggests that CAR-T cells produced with HCW9206 may be a more effective and long-lasting CAR-T cell immunotherapy than conventional CAR-T produced using αCD3/28/IL-2.

In this article, the authors demonstrate in a humanized mouse model of HIV-1 infection utilizing T cells from people living with HIV (PLWH), HCW9206 enabled generation of duoCAR-T cells composed of a highly enriched Tscm population, which supported long-term persistence and functional activity in vivo, along with the effector memory T cells (TEM) population capable of providing immediate and potent HIV-1 suppression. Utilizing HCW9206 in the manufacture of CAR-Ts may advance HIV immunotherapy by introducing a new strategy that may produce functionally persistent product, thereby extending the lifespan of anti-HIV CAR-T therapy in PLWH and potentially enabling a functional cure. The authors also show how anti-cancer CD19-CAR-T cells manufactured using HCW9206 exhibited a greater capacity to mount a protective proliferative response in vivo, as indicated by the effective suppression of tumor cell expansion after rechallenging with CD19+ cancer cells by HCW9206-generated CD19-CAR-T cells compared to the (αCD3/28)-generated CD19-CAR-Tcells in multiple humanized animal models.

The authors of this article also reported that antigen stimulation of duoCAR-T produced with HCW9206 significantly upregulated the expression of SATBI1 (special AT-rich sequence-binding protein 1), a gene previously reported to be a key determinant in linage commitment through chromatin reorganization. Specifically, SATB1 has been shown to be a key regulator of CD8+ T-cell quiescence and stemness, as well as promoting early effector cell expansion and differentiation to support both effector responses and long-term T-cell persistence.

Taken together, these data demonstrate that manufacturing human T cells with HCW9206 produces HIV- and CD19-specific CAR-T cells that are highly enriched for the Tscm memory phenotype, as well as human effector T cells capable of maintaining suppression of HIV and leukemic cell proliferation in experimental models. Therefore, generating human CAR-T cells utilizing HCW9206 could provide a new, improved, and highly scalable method for generating human CAR-T cells to treat patients with infectious disease and cancer and replace standard CAR-T cell production using αCD3/28 activation. This has widespread implications for the generation of more robust CAR-T cell-based immunotherapies with the potential to improve CAR-T cell functional persistence and efficacy for treatment of HIV and cancer.

The authors are Natalia Valderrama Pena, B.S., Niraj Shrestha, Ph.D., and Hing Wong, Ph.D. at HCW Biologics; along with Sara Lamcaj, Ph.D., Agnes Sydenstricker, B.S., Adilyn Voss, B.S., Christopher Hiner, Ph.D., and Jian Hua Zheng, B.S., Harris Goldstein, M.D. at Albert Einstein College of Medicine; Ying Xiong, Ph.D., Zhongyu Zhu, Ph.D., and Boro Dropulić, Ph.D., at Caring Cross; and Cheng Cheng Zhang, Ph.D. at University of Texas Southwestern Medical Center, Dallas, TX.

(Press release, HCW Biologics, MAR 16, 2026, View Source [SID1234663589])