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])

On March 16, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT reported that CFO Raphi Levy will present at the Sidoti Virtual Small Cap Conference taking place on March 18-19, 2026.

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Event: Sidoti Virtual Small Cap Conference
Format: Company Presentation
Date: March 18, 2026
Time: 10:00 – 10:30AM ET
Location: Virtual

Mr. Levy will be available for 1×1 investor meetings at the conference. Please reach out to your Sidoti representative to schedule.

(Press release, Alpha Tau Medical, MAR 16, 2026, View Source [SID1234663588])

On March 16, 2026 Perspective Therapeutics, Inc. ("Perspective," the "Company," "we," "us," and "our") (NYSE AMERICAN: CATX), a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body, reported a business update and announced full year results for the year ended December 31, 2025.

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"The rich flow of data readouts in 2026 reflects years of dedication by our team to develop transformational new treatment options for patients in need of more choices," said Thijs Spoor, Perspective’s CEO. "We look forward to evaluating how these results will inform next steps for advancing our lead program VMT-α-NET and contribute to our understanding of the broader potential of our proprietary next-generation targeted radiopharmaceutical technology."

Advancing the current clinical pipeline

VMT-α-NET

We are conducting a multi-center, open-label, dose-finding study (clinicaltrials.gov identifier NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2)-positive neuroendocrine tumors (NETs) who have not received prior radiopharmaceutical therapies (RPT).

Updated interim data from the study, as of a data-cut off (DCO) date of December 10, 2025, were presented at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium ("ASCO-GI 2026"). Highlights from the updated analysis included the following:

Safety findings based on 56 patients who received at least one treatment:

The 56 patients in this safety analysis comprised 2 patients in Cohort 1 (2.5 mCi), 46 patients in Cohort 2 (5.0 mCi), and 8 patients in Cohort 3 (6.0 mCi).
There were no reports of dose limiting toxicities (DLTs), treatment-related discontinuations, serious renal complications, dysphagia, or clinically significant treatment-related myelosuppression.
Grade 3 or higher treatment-emergent adverse events were reported in 21 patients (37.5%). One of these patients, who was enrolled in Cohort 3, experienced a transient Grade 4 event (lymphocyte count decrease). This event was transient and resolved without medical intervention. The patient continues to receive [212Pb]VMT-α-NET treatment. There were no Grade 5 events.
Serious adverse events were reported in 5 patients, with none deemed related to the study medication.
Anti-tumor activity reported at ASCO (Free ASCO Whitepaper)-GI in January 2026, based on both patients in Cohort 1 and 23 (half) of the patients enrolled in Cohort 2:

Updated efficacy analysis in the same 25 patients from ESMO (Free ESMO Whitepaper) Congress 2025 ("ESMO 2025") in October 2025 was presented with an additional ~13 weeks of follow-up since the previous presentation at ESMO (Free ESMO Whitepaper) 2025.
19 of the 25 patients (76%) were without progression and remained alive, including both patients in Cohort 1.
Nine (39%) patients in Cohort 2 were observed to have response according to investigator-assessed RECIST v1.1. Eight (35%) of those responses were confirmed and previously reported at ESMO (Free ESMO Whitepaper) 2025. One additional patient experienced an initial response in their most recent tumor assessment after the prior update at ESMO (Free ESMO Whitepaper) 2025. As the patient remains on study, the patient is expected to receive a subsequent tumor assessment.
Seven patients were observed to have deepening of best response, including one patient with stable disease.
As of February 28, 2026, the first 23 patients in Cohort 2 would have had the opportunity for at least 48 weeks of follow-up since beginning treatment. By mid-2026, we expect all 46 patients in Cohort 2 would have had the opportunity for at least 48 weeks of follow-up since beginning treatment.

Cohort 3 opened in June 2025 after alignment was reached with the FDA, as previously agreed prior to the initiation of this study in 2023. Patients in Cohort 3 are receiving up to four fixed administered doses of [212Pb]VMT-α-NET at 6.0 mCi, every eight weeks, if they weigh more than 60kg (133lb), or 100μCi/kg of body weight if they weigh less than or equal to 60kg.

After the opening of Cohort 3 was announced in June 2025, eight Cohort 3 patients commenced treatment and contributed to dose-limiting toxicity (DLT) assessment by a safety monitoring committee (SMC). The DLT assessment is now complete, and we are cleared to treat more patients at this dose, with an additional eight patients already treated as of February 28, 2026, for a total of 16 patients in Cohort 3.

By mid-2026, the eight DLT patients in Cohort 3 would have had the opportunity for at least 32 weeks of follow-up since beginning treatment, sufficient time to have completed at least one scan following the full course of treatment.

We believe our clinical data package positions us for meaningful regulatory engagement in 2026 to align on the path forward.

During the dose finding phase of the study, we enrolled primarily NETs patients whose disease originated in the pancreas or the digestive track. We have allowance for enrollment of NETs patients whose disease originated in the lung (of which small cell lung cancer is a subset), and pheochromocytoma/paraganglioma NETs, as well as SSTR2+ meningioma.

VMT01

VMT01 is a MC1R-targeted RPT that can be radiolabeled with either 203Pb for patient selection and dosimetry assessments, or 212Pb for alpha particle therapy.

We are conducting a multi-center, open-label, dose-finding study (clinicaltrials.gov identifier NCT05655312) in heavily pre-treated patients with histologically confirmed melanoma and MC1R-positive imaging scans.

Most recently, patients have received treatments at 3.0 mCi, either as monotherapy or in combination with nivolumab, a PD-1 blocking antibody developed and marketed by Bristol Myers Squibb as Opdivo.

Since dosing re-opened for 3.0 mCi of VMT01 as monotherapy, and was initiated for 3.0 mCi of VMT01 in combination with nivolumab in September 2025, 10 patients had received VMT01 3.0 mCi treatment as of February 28, 2026; six patients had received VMT01 at 3.0 mCi in combination with nivolumab, and four patients had received 3.0 mCi of VMT01 as monotherapy, in addition to the three patients who received this monotherapy dose in late 2023. Both cohorts are now closed for enrollment.

By late 2026, the 10 patients who had received VMT01 3.0 mCi treatment since the initiation or re-opening of these cohorts in September 2025 would have had the opportunity for at least 24 weeks of follow-up after their initial doses, sufficient time to have completed at least one scan after the full course of treatment (up to three doses every eight weeks).

PSV359

We designed PSV359 to target and deliver 212Pb to tumor sites expressing fibroblast activation protein-α, or FAP-α, associated with multiple highly prevalent solid tumors, with patients in need of additional treatment options. The targeting moiety may also be radiolabeled with 203Pb or 68Ga and 64Cu to detect FAP-α expression in individual patients. Preclinical imaging and therapy as well as human imaging results suggest our proprietary targeting ligand has improved levels of target engagement and uptake in tumors, as well as reduced retention in healthy tissues, which may result in a desirable therapeutic index.

As of February 28, 2026, two patients in Cohort 1 had been treated with [212Pb]PSV359 at 2.5 mCi, and six patients in Cohort 2 had been treated at 5.0 mCi, for a total of eight patients. By late 2026, these patients would have had the opportunity for at least 32 weeks of follow-up after their initial doses, sufficient time to have completed at least one scan after the full course of treatment (up to four doses every eight weeks). Activation activities are underway for additional sites.

Updates to the preclinical pipeline

Our discovery team is preparing additional novel constructs for potential first-in-human (FIH) imaging. If and when those constructs meet our criteria for further development, we plan to proceed with pre-IND filing activities. During the fourth quarter of 2025, we decided not to pursue further development of one early-stage preclinical asset, while activities continue on multiple other preclinical assets.

Updates on manufacturing infrastructure

We continue to make progress on expanding our manufacturing capabilities by increasing and enhancing capacity at existing facilities and building out recently acquired sites.

Full Year 2025 Financial Summary

Cash, cash equivalents, and short-term investments as of December 31, 2025 were approximately $145 million as compared to $227 million as of December 31, 2024. In February 2026, we announced the closing of an underwritten offering of securities with net proceeds of approximately $164 million after deducting underwriting discounts and commissions and other offering-related expenses. We believe our cash, cash equivalents and short-term investments as of December 31, 2025, together with the net proceeds from the February 2026 offering, will be sufficient to fund our current clinical milestones and operational investments into late 2027.

As of December 31, 2025, we had approximately 74.3 million shares of common stock and approximately 10.9 million warrants and options to purchase shares of common stock outstanding. In connection with the February 2026 underwritten offering of securities noted above, we issued 39.6 million shares of common stock along with pre-funded warrants to purchase 6.6 million shares of common stock.

Grant revenue was $0.9 million for the year ended December 31, 2025, compared to approximately $1.5 million for the year ended December 31, 2024. Grant revenue is derived from our work with the National Institutes of Health.

Research and development expenses were $84.2 million for the year ended December 31, 2025, compared to $41.6 million for the year ended December 31, 2024, an increase of approximately 102%. The increase in research and development expenses was primarily related to increased clinical site activities, drug program costs and delivery costs along with higher personnel costs, including share-based compensation.

Research and development expenses additionally included a $10.0 million non-cash impairment loss for the three months ended December 31, 2025, in connection with our decision to deprioritize an early-stage preclinical asset within our in-process research and development portfolio. This early-stage preclinical asset was acquired as part of the merger between Viewpoint Molecular Targeting, Inc. and Isoray, Inc. in February 2023.

General and administrative expenses were $30.2 million for the year ended December 31, 2025, compared to $26.6 million for the year ended December 31, 2024, an increase of approximately 14%. The increase in general and administrative expenses for the year ended December 31, 2025 was primarily due to increased personnel costs, partially offset by decreased fees for professional services.

Total operating expenses for the year ended December 31, 2025 were $114.4 million (including a non-cash, one-time impairment loss for a preclinical asset of $10.0 million), compared to $92.3 million for the same period in 2024 (including a non-cash, one-time goodwill impairment charge of $24.1 million), an increase of approximately 24%.

Net loss for the year ended December 31, 2025 was $103.1 million, or $1.40 per basic and diluted share, compared to a net loss of $79.3 million, or $1.23 per basic and diluted share, for the same period in 2024. During the year ended December 31, 2025, there was a net benefit of $7.7 million in net interest income and other expense, compared to a net benefit of $10.5 million in net interest income and other expense during the year ended December 31, 2024.

(Press release, Perspective Therapeutics, MAR 16, 2026, View Source [SID1234663587])

On March 16, 2026 Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported the company has entered into a supply agreement with Johnson & Johnson to evaluate MRT-2359 in combination with ERLEADA (apalutamide) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) with androgen receptor (AR) mutations in a planned Phase 2 study expected to initiate in the third quarter of 2026. MRT-2359 is an investigational, orally bioavailable, GSPT1-directed MGD discovered and developed by Monte Rosa. ERLEADA is an AR inhibitor developed by Janssen Research and Development, LLC, indicated for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) and patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

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Under the terms of the agreement, Monte Rosa will conduct and sponsor the trial and Johnson & Johnson will provide ERLEADA as part of a supply agreement.

"We are pleased to enter into this supply agreement with Johnson & Johnson to further explore the potential of MRT-2359 in combination with next-generation AR inhibitors such as apalutamide in patients with advanced prostate cancer," said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. "Based on the compelling clinical activity observed to date in heavily pretreated patients with AR mutations, we believe this combination approach holds significant promise. Data generated from these studies have the potential to further confirm MRT-2359’s clinical activity and may position the program for advancement into registrational studies, representing an important step forward for prostate cancer patients with limited therapeutic options for this respective patient population."

The planned Phase 2 study of up to 25 mCRPC patients is designed to efficiently assess the efficacy and safety of MRT-2359 plus ERLEADA in mCRPC patients with AR mutations, with potential to expand the study into additional patient subsets, including patients naïve to next-generation AR inhibitors, should the activity in the AR mutant patient population confirm. The study will evaluate PSA response, RECIST response, duration of response, progression-free survival (PFS), radiographic progression-free survival (rPFS), and safety.

Monte Rosa recently announced additional, positive data from the company’s ongoing Phase 1/2 clinical study evaluating MRT-2359 in combination with enzalutamide in heavily pretreated patients with mCRPC. The data were presented at the 2026 ASCO (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium on February 26, 2026.

About MRT-2359
MRT-2359 is a potent, highly selective, and orally bioavailable investigational molecular glue degrader (MGD) of GSPT1. MYC-driven cancers, including prostate cancer, depend on enhanced translation of oncoproteins to support rapid growth. MRT-2359 exploits this therapeutic vulnerability by disrupting translation through selective degradation of the translation termination factor GSPT1. MRT-2359 treatment reduced cellular abundance of many prostate cancer-relevant oncoproteins, including AR, MYC, and Cyclin D1-E2F, and demonstrated robust anti-tumor activity across multiple preclinical models of metastatic castration-resistant prostate cancer (mCRPC). MRT-2359 in combination with the AR inhibitor enzalutamide is being investigated in an ongoing Phase 1/2 study (clinicaltrials.gov identifier NCT05546268) in patients with mCRPC. In heavily pretreated mCRPC patients, MRT-2359 plus enzalutamide demonstrated encouraging early signals of clinical response.

(Press release, Monte Rosa Therapeutics, MAR 16, 2026, View Source [SID1234663586])