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Curatis and Neupharma Announce Exclusive Licensing Agreement to Develop and Market Corticorelin (C-PTBE-01) for the Treatment of Peritumoral Brain Edema in Japan

On March 11, 2026 Curatis Holding AG (SIX: CURN) and Neupharma Co., Ltd. ("Neupharma"), a Japanese pharmaceutical company specializing in oncology, immunology, pulmonology and cardiology disorders, reported an exclusive license and development agreement for corticorelin (C-PTBE-01) in Japan.

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Under the terms of the agreement, Neupharma will receive exclusive rights to develop and commercialize corticorelin for the treatment of peritumoral brain edema (PTBE) in Japan. PTBE is a tumor-associated condition for which no approved targeted therapies currently exist. Neupharma will finance and conduct a pivotal clinical trial in Japan to support filing for approval in Japan. Curatis will receive upfront and milestone payments for the achievement of regulatory and commercial targets totaling up to CHF 83.5 million, as well as royalties on future sales in Japan of up to 20%.

The agreement stipulates that corticorelin is planned to be introduced in Japan initially for children and adolescents. A meeting with the Japanese drug regulatory authority PMDA to discuss the registration enabling study is planned for summer 2026, and the clinical study is expected to start in 2027.

At the same time, preparatory work for the pivotal Phase 3 study for approval in the US and Europe as well as global partnering activities are proceeding as planned.

Corticorelin / C-PTBE-01

Curatis’ lead product candidate, C-PTBE-01 (corticorelin), is being developed to treat peritumoral brain edema (PTBE). PTBE occurs in association with many primary and metastatic (secondary) brain tumors, often in connection with metastases caused by lung cancer, breast cancer, melanoma and colorectal cancer. PTBE results in impairment of brain function due to the accumulation of extracellular fluid around the tumor and can cause symptoms such as headaches, vomiting and neurological dysfunction such as paralysis, speech disorders, visual problems and altered mental status. Standard of care treatment for PTBE is the use of corticosteroids which frequently have serious side effects such as severe myopathy, impaired glucose metabolism, muscle wasting, abnormal weight gain, osteoporosis, gastritis, gastrointestinal bleeding, hypertension and personality changes. Additionally, corticosteroids can also counteract certain cancer therapies such as chemotherapy or emerging immunotherapies that rely on adequate T-cell functionality which is impaired by corticosteroids.

Corticorelin (hCRH), a 41 amino acid endogenous polypeptide, has demonstrated preclinically (in vivo) the ability to positively impact the blood-brain barrier after a disruption due to the underlying malignant tumor. In two clinical studies in patients with PTBE, corticorelin demonstrated the potential to substantially reduce, or in some cases completely replace, steroid use, which may reduce or avoid the severe glucocorticoid-related side effects and subsequently improve quality of life. In the US alone, more than 150,000 patients suffer from PTBE. The estimate for the potential market opportunities for corticorelin is therefore over USD 1 billion per year. Corticorelin is an investigational drug not approved for therapeutic use in the United States or outside the United States.

(Press release, Neupharma, MAR 11, 2026, https://www.businesswire.com/news/home/20260310112972/en/Curatis-and-Neupharma-Announce-Exclusive-Licensing-Agreement-to-Develop-and-Market-Corticorelin-C-PTBE-01-for-the-Treatment-of-Peritumoral-Brain-Edema-in-Japan [SID1234663463])

Parabilis Medicines’ Zolucatetide, the First and Only Direct Inhibitor of the Elusive β-catenin:TCF Interaction, Receives FDA Orphan Drug Designation for the Treatment of Desmoid Tumors

On March 11, 2026 Parabilis Medicines, a clinical-stage biopharmaceutical company committed to creating extraordinary medicines for people living with cancer using its Helicon TM peptide platform to drug historically undruggable targets, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to zolucatetide (previously known as FOG-001), the company’s lead investigational HeliconTM peptide and the first and only direct inhibitor of the elusive β-catenin:TCF interaction, for the treatment of desmoid tumors. Zolucatetide has also received FDA Fast Track Designation in desmoid tumors.

"Patients living with desmoid tumors have lacked therapies that directly address the root biological cause of their disease because that biology, the β-catenin:TCF interaction, has long been considered ‘undruggable,’" said Mathai Mammen, M.D., Ph.D., Chairman, CEO and President of Parabilis Medicines. "With Orphan Drug Designation and Fast Track Designation from the FDA, along with compelling early clinical data showing encouraging evidence of clinical activity, we are building momentum behind zolucatetide as a potential first-in-class therapy that we believe could help redefine the standard of care for patients with desmoid tumors and other tumors driven by the same elusive biology. We are committed to advancing this program with rigor and speed to deliver meaningful impact for patients."

Desmoid tumors are considered a rare condition involving locally invasive soft-tissue tumors that form in the connective tissues. While they do not metastasize, desmoid tumors can be aggressive and recurrent, often causing chronic and significant pain, limited mobility, disfigurement and organ dysfunction, and no existing therapies target the underlying biology of the disease.

Zolucatetide is an investigational first-in-class inhibitor of the Wnt/β-catenin pathway, which is the fundamental driver of desmoid tumor growth. Orphan Drug Designation follows early data, first released at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting, demonstrating that zolucatetide has shown evidence of clinically meaningful antitumor activity in desmoid tumors, including tumor reductions and 100% disease-control rate (DCR) in all 10 patients with at least one post-baseline scan and an 80% objective response rate (ORR) in the five patients with more than one post-baseline scan per RECIST 1.1.

The FDA grants Orphan Drug Designation to drugs and biologics that are intended for safe and effective treatment, diagnosis or prevention of rare diseases or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain incentives, such as tax credits towards the cost of clinical trials upon approval and prescription drug user fee waivers. Products with Orphan Drug Designation status are also entitled to a potential seven years of regulatory exclusivity following regulatory approval.

Beyond desmoid tumors, zolucatetide is being evaluated across a broad range of rare and common Wnt/β-catenin-driven tumor types. Clinical data presented at the AACR (Free AACR Whitepaper)-NCI-EORTC 2025 meeting showed zolucatetide had single-agent activity in five low-complexity tumor types where Wnt/β-catenin mutations are the primary drivers of disease – including desmoid, adamantinomatous craniopharyngioma (ACP), ameloblastoma, salivary gland cancer, and solid pseudopapillary neoplasm (SPN) – with strong scientific rational for combination therapy in more complex cancers such as microsatellite-stable colorectal cancer (MSS CRC). Parabilis also shared early data indicating the potential of zolucatetide in hepatocellular carcinoma (HCC) and familial adenomatous polyposis (FAP) at the JP Morgan Healthcare conference earlier this year.

The company plans to share additional data readouts in 2026 from its ongoing Phase 1/2 trial of zolucatetide, in which more than 150 patients have been dosed to date.

About Zolucatetide (Previously FOG-001)

Zolucatetide is an investigational first-in-class competitive inhibitor of β-catenin interactions with the T-cell factor (TCF) family of transcription factors and is currently in clinical development. By directly targeting the β-catenin:TCF protein-protein interaction, zolucatetide is intended to block the Wnt signaling pathway irrespective of the various APC and β-catenin mutations that typically drive disease.

Zolucatetide combines key features that distinguish it from previously reported Wnt/β-catenin pathway modulators: zolucatetide acts inside the cell where it binds directly to the key oncogenic driver β-catenin; and zolucatetide blocks the Wnt pathway at the key downstream node, disrupting the interaction between β-catenin and the TCF transcription factors, thereby abrogating the signal transmission by which Wnt pathway mutations are believed to drive oncogenesis.

Zolucatetide is currently being evaluated in a Phase 1/2 clinical trial in patients with locally advanced or metastatic solid tumors. Zolucatetide has received Fast Track Designation and Orphan Drug Designation for the treatment of desmoid tumors from the U.S. Food and Drug Administration (FDA).

About the Phase 1/2 trial of Zolucatetide

Zolucatetide is being evaluated in a Phase 1/2 multicenter, open-label study (NCT05919264) assessing its safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity. The trial includes dose-escalation and dose-expansion phases and is testing zolucatetide both as a monotherapy and in combination with other anticancer agents in patients with advanced or metastatic solid tumors likely or known to harbor a Wnt pathway–activating mutation (WPAM).

(Press release, Parabilis Medicines, MAR 11, 2026, View Source;cateninTCF-Interaction-Receives-FDA-Orphan-Drug-Designation-for-the-Treatment-of-Desmoid-Tumors [SID1234663462])

Tempus Announces Study Highlighting the Role of Advanced Genomic Profiling Features in Identifying Clinically Actionable Findings

On March 11, 2026 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported the publication of a new study in JCO Precision Oncology highlighting how advanced features of comprehensive genomic profiling (CGP) expand treatment options for cancer patients in community oncology settings. The study, conducted in collaboration with The Oncology Institute (TOI), reveals that features such as tumor-normal matched sequencing, RNA sequencing, and liquid biopsy reflex identify actionable findings that are missed by more limited standard in-network testing.

While organizations like ASCO (Free ASCO Whitepaper) and the NCCN strongly advocate for CGP to guide precision therapies, current guidelines often lack specificity regarding the exact composition or essential features required within these panels. This research demonstrates that CGP value extends far beyond simple panel size, highlighting the utility of advanced testing features to more fully capture clinically relevant findings.

In the study, 12% (approximately 1 in 8) of patients across the pilot and expanded cohorts had potentially actionable findings associated with an approved therapy identified solely through advanced Tempus features—such as tumor-normal matching, RNA sequencing, and liquid biopsy reflex testing—that would otherwise have been missed by less comprehensive tests.

"This study demonstrates a clear clinical mandate: to truly provide precision medicine, we must utilize the most comprehensive tools available," said Ezra Cohen, MD, Chief Medical Officer, Oncology at Tempus and a coauthor of the study. "Advanced testing capabilities expand access to targeted treatments and clinical trial opportunities, while providing clinicians with a more comprehensive view of clinically relevant findings. This underscores the critical role Tempus plays in helping clinicians ensure that no stone is left unturned for their patients."

(Press release, Tempus, MAR 11, 2026, View Source [SID1234663461])

Verrica Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results

On March 11, 2026 Verrica Pharmaceuticals Inc. ("Verrica") (Nasdaq: VRCA), a therapeutics company developing and commercializing medications for the treatment of dermatological diseases, including skin cancers, reported financial results for the fourth quarter and full year ended December 31, 2025.

"In 2025, Verrica successfully implemented a series of transformational changes that we believe have fundamentally improved the future growth and strategic value of our entire business," said Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica. "Our focused and efficient commercial strategy allowed us to nearly double dispensed applicator units of YCANTH from the prior year while cutting selling, general and administrative expenses by over 40% over that same period. This February, we dispensed more applicators of YCANTH per selling day than in any month in our history, reflecting strong and increasing demand for YCANTH. We are poised to advance our late-stage clinical pipeline in common warts and basal cell carcinoma, which collectively could represent a multiple billion-dollar opportunity. Finally, in 2025 we significantly improved our financial position, repaying our outstanding debt while extending our cash runway into the first quarter of 2027.

"Looking ahead, in addition to growing YCANTH sales in the United States we have multiple potential avenues to continue building value by entering new markets and expanding our product portfolio. Our first international partnership for YCANTH, with Torii Pharmaceutical, has now launched in Japan. After recently gaining alignment with regulators for YCANTH’s approval pathway in the European Union, we are now able to more meaningfully engage in discussions with additional potential commercialization partners, which could provide a significant source of non-dilutive funding and future revenue for the Company," Dr. Rieger continued.

"We are also advancing toward pivotal Phase 3 studies of VP-315 for the treatment of basal cell carcinoma. VP-315 represents a unique opportunity to introduce a novel immunotherapy with potential abscopal activity that could become a primary or neoadjuvant, non-surgical treatment option for this large patient population. With the opportunity to grow YCANTH in the United States, enter new markets and develop transformative medicines, we are tremendously excited about what 2026 has in store for Verrica and our patients," Dr. Rieger concluded.

Conference Call and Webcast Information

The Company will host a conference call on Wednesday, March 11, 2026, at 8:30 am, to discuss its fourth quarter and full year 2025 financial results and provide a business update. To participate in the conference call, please utilize the following information:

Domestic Dial-In Number: Toll-Free: 1-800-343-4136

International Dial-In Number: 1-203-518-9843

Conference ID: VERRICA

Participants can use Guest dial-in #s above and be answered by an operator.

Webcast:

View Source;tp_key=9018bdf1ab

The call will be broadcast live over the Web and can also be accessed on Verrica Pharmaceuticals’ website: www.verrica.com.

The conference call will also be available for replay for one month on the Company’s website in the Events Calendar of the Investors section.

Business Highlights and Recent Developments

YCANTH (VP-102)

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During the fourth quarter of 2025, YCANTH dispensed applicator units totaled 13,654, representing a year-over-year increase of 58% from the fourth quarter of 2024. On a sequential basis, YCANTH dispensed applicator units decreased approximately 3% from the prior quarter.

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In the first quarter of 2026, while January was likely impacted somewhat by significant winter weather across the East Coast, dispensed applicator units per selling day in February rebounded, reaching a record monthly high since launch.

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In September 2025, Verrica announced that its partner, Torii Pharmaceutical Co. Ltd. ("Torii"), a wholly-owned subsidiary of Shionogi & Co., Ltd., received approval from the Japanese Ministry of Health, Labour and Welfare for YCANTH for the treatment of molluscum. On February 9, 2026, the Company announced the commercial launch of YCANTH in Japan by Torii for the treatment of molluscum contagiosum.

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On January 7, 2026, the Company announced that the first patient was dosed in December 2025 in the global Phase 3 program evaluating YCANTH (VP-102) for the treatment of common warts. The Phase 3 program was initiated based upon the clinically meaningful activity observed for the primary endpoint of complete clearance in the Phase 2 COVE-1 study. These results, if replicated in the Phase 3 program, support the potential for YCANTH to become the first therapy approved in either the United States or Japan for the treatment of common warts, a condition that impacts over 22 million people in the United States alone. The Company has retained full commercial rights for all potential YCANTH indications outside of Japan and believes that YCANTH for common warts could represent a substantial commercial and licensing opportunity.

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The Company launched YcanthRx in the fourth quarter of 2025, a new non-dispensing pharmacy option. YcanthRx is designed to provide prescribers a central hub option for YCANTH prescriptions to assist with benefits investigations and prior authorizations. Prescriptions written to YcanthRx are then routed to a dispensing pharmacy in the Company’s pharmacy network that is contracted with the patient’s insurance plan, where available.

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On October 20, 2025, the Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency provided positive feedback that supports the filing of a Marketing Authorization Application for YCANTH as a treatment for molluscum contagiosum. Based on Verrica’s comprehensive efficacy and safety data from the well-controlled Phase 3 studies successfully conducted in both the U.S. and Japan, the CHMP concluded that no further Phase 3 clinical studies are needed to progress toward a filing for approval.

VP-315

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On November 4, 2025, the Company presented new data on VP-315 from its Phase 2 trial in basal cell carcinoma (BCC) at the 40th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The presentation revealed supportive immunologic mechanistic data that helps explain why VP-315 shrinks treated basal cell carcinomas in many patients (as evidenced by a 97% objective response rate and an 86% reduction in overall tumor size).

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The Company is now providing additional data on the abscopal response in 14 observed but not treated lesions from the Phase 2 study, which suggests immune system engagement. Specifically, 3 out of the 14 lesions had complete histologic clearance and there was a 67% overall reduction in tumor size across all 14 lesions. Additional details on this observation are being planned for discussion at a scientific conference later this year.

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On November 14, 2025, the Company announced that the FDA confirmed alignment with the Company’s plan for the Phase 3 program for BCC to encompass two placebo-controlled Phase 3 studies with approximately 100 subjects each and a primary endpoint of complete clearance as assessed at week 14. Based on the discussion with the FDA, the Company expects these studies will be adequate to support a New Drug Application filing, with long-term follow-up studies to be conducted as post-approval commitments.

CORPORATE

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On February 12, 2026, the Company announced the appointment of Chris Chapman as its Chief Commercial Officer. Mr. Chapman brings over 25 years of commercial experience in the pharmaceutical industry to Verrica, and most recently served as Chief Commercial Officer at Dermavant Sciences through its acquisition by Organon, where he played an instrumental role in launching VTAMA (tapinarof) cream, 1%, approved for adult plaque psoriasis in June 2022 and atopic dermatitis in December 2024.

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On November 24, 2025, the Company announced a private placement of $50 million anchored by Caligan Partners LP and PBM Capital, along with other new and existing investors. The Company used $35.0 million of the net proceeds to fully repay its outstanding obligations and terminate all outstanding commitments under its Credit Agreement, and the remainder for working capital and general corporate purposes. With these proceeds and its existing cash and cash equivalents, the Company expects its cash runway to fund operations into the first quarter of 2027.

Financial Results

Fourth Quarter 2025 Financial Results

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Product revenue, net was $3.7 million for the three months ended December 31, 2025, compared to net product revenue of $0.3 million for the three months ended December 31, 2024. The increase in product revenue was based on higher demand for YCANTH. Product revenue, net, relates to the delivery of YCANTH to Verrica’s distribution partners.

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License and collaboration revenue was $1.4 million for the three months ended December 31, 2025, consisting primarily of commercial supply for Torii’s YCANTH launch in Japan. License and collaboration revenue was not material for the three months ended December 31, 2024.

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Costs of product revenue were $0.7 million for the quarter ended December 31, 2025, compared to $0.6 million for the quarter ended December 31, 2024.

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Selling, general and administrative expenses were $8.1 million for the quarter ended December 31, 2025, compared to $9.9 million for the same period in 2024. Excluding the impact of stock-based compensation, the decrease of $1.8 million was primarily due to lower expenses related to commercial activities for YCANTH.

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Research and development expenses were $2.5 million for the quarter ended December 31, 2025, compared to $1.2 million for the same period in 2024. Excluding the impact of stock-based compensation, the increase was primarily attributable to costs associated with the Phase 3 program for common warts and compensation.

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Interest income was $0.2 million for the quarter ended December 31, 2025, which was unchanged from the quarter ended December 31, 2024.

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Interest expense was $1.3 million for the quarter ended December 31, 2025, compared to $2.3 million for the same period in 2024. Interest expense was related to borrowings under the Company’s now-repaid Credit Agreement. The decrease of $1.0 million was related to a lower principal balance and the termination of the Credit Agreement in November 2025.

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For the quarter ended December 31, 2025, net loss was $8.1 million, or $0.57 per basic and diluted share, compared to a net loss of $16.2 million, or $2.41 per share, for the same period in 2024.

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For the quarter ended December 31, 2025, non-GAAP net loss was $7.2 million, or $0.51 per basic and diluted share, compared to a non-GAAP net loss of $12.2 million, or $1.81 per share, for the same period in 2024.

Full Year 2025 Financial Results

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Product revenue, net was $15.3 million for the twelve months ended December 31, 2025, compared to $6.6 million for the twelve months ended December 31, 2024. For the twelve months ended December 31, 2025, product revenue, net was primarily related to increased demand for YCANTH.

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License and collaboration revenue was $20.3 million for the twelve months ended December 31, 2025, compared to $1.0 million for the twelve months ended December 31, 2024. License and collaboration revenue for the twelve months ended December 31, 2025, consisted primarily of $18.0 million in milestone payments and $2.3 million of revenue related to commercial supplies and development activity from the Collaboration and License Agreement with Torii.

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Costs of product revenue were $2.2 million for the twelve months ended December 31, 2025, compared to $1.9 million for the twelve months ended December 31, 2024. The increase was due to increased sales of YCANTH partially offset by higher obsolete inventory reserves in the prior period.

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Selling, general and administrative expenses were $35.2 million during the twelve months ended December 31, 2025, compared to $58.8 million for the same period in 2024. Excluding the impact of stock-based compensation, the decrease of $20.6 million was primarily due to lower expenses related to commercial activities for YCANTH, including decreases in compensation, benefits and travel due to reduced sales force of $6.9 million, decreased commercial costs of $6.6 million, decreased compensation of $2.7 million related to termination of non-sales employees, decreased travel and fleet costs of $2.0 million and decreased legal and administrative costs of $2.3 million.

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Research and development expenses were $8.9 million for the twelve months ended December 31, 2025, compared to $11.8 million for the same period in 2024. Excluding stock-based compensation, the decrease of $2.1 million was primarily attributable to decreased clinical costs for VP-315.

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Interest income was $0.9 million for the twelve months ended December 31, 2025, compared to $1.4 million for the same period in 2024. The decrease of $0.5 million was primarily due to a lower cash balance.

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Interest expense was $7.7 million for the twelve months ended December 31, 2025, and $9.4 million for the same period in 2024. Interest expense is related to borrowings under the Credit Agreement, which was terminated in November 2025. The decrease of $1.7 million was primarily related to a lower principal balance and the termination of the Credit Agreement.

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For the twelve months ended December 31, 2025, net loss was $17.9 million, or $1.68 per share, compared to a net loss of $76.6 million, or $14.78 per share, for the same period in 2024.

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For the twelve months ended December 31, 2025, non-GAAP net loss was $13.2 million, or $1.24 per share, compared to a non-GAAP net loss of $64.6 million, or $12.47 per share, for the same period in 2024.

(Press release, Verrica Pharmaceuticals, MAR 11, 2026, View Source [SID1234663460])

Tempest Announces Partnership for TPST-2003 in Preparation for Planned U.S. Registrational Study in 2026

On March 11, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest"), a clinical-stage biotechnology company developing a pipeline of advanced CAR-T cell therapy product candidates to treat cancer, reported the selection of Cincinnati Children’s Applied Gene and Cell Therapy Center ("AGCTC") as the lead contract development and manufacturing partner to conduct the formal technology transfer of TPST-2003, Tempest’s dual-targeting CD19/BCMA CAR-T therapy under development for the treatment of relapsed/refractory multiple myeloma ("rrMM").

Tempest recently announced that, as of a January 31, 2026 data cutoff, a total of 36 patients with rrMM had received one infusion of TPST-2003, including 24 patients in a prior Phase 1/2 investigator-initiated trial (IIT) and 12 patients in the ongoing REDEEM-1 trial, representing one of the largest datasets evaluating a CD19/BCMA dual-targeting CAR-T therapy. As of the data cutoff, all six efficacy evaluable patients enrolled in the REDEEM-1 trial had achieved a complete response (CR) according to the International Myeloma Working Group (IMWG) uniform response criteria. Among 25 evaluable patients with measurable disease at baseline across both studies, the overall response rate ("ORR") was 100% (25/25). Tempest plans to present the results of the REDEEM-1 trial and updated results from the IIT at a scientific meeting later this year.

"The recent positive results from the ongoing REDEEM-1 trial position TPST-2003 as a potential class-leading therapy for rrMM, which, subject to FDA approval, could offer a meaningful option for patients with rrMM," said Dr. Matt Angel, President and Chief Executive Officer of Tempest. "The potential to treat patients with extramedullary disease (EMD) and patients who have previously received a BCMA-targeting CAR-T is particularly exciting. We are very pleased to have selected the AGCTC as our partner to execute the technology transfer of TPST-2003 as we prepare for our planned U.S. clinical development."

The AGCTC is a research, development, and manufacturing hub advancing future cell and gene therapy (CGT) treatments for patients with unmet needs. Established in 2001, the center has evolved into a nationally recognized leader in CTG CDMO services with a proven track record that reflects Cincinnati Children’s commitment to solving unmet medical needs through translational science. AGCTC is part of the Cincinnati Children’s Cancer and Blood Diseases Institute, which is ranked #1 in the nation by U.S. News & World Report for pediatric cancer care.

"We are proud to have been selected to support the development of this exciting product candidate," said Dr. Chaozhong Zou, Executive Director and General Manager of AGCTC, Cancer and Blood Diseases Institute, Cincinnati Children’s Hospital Medical Center. "The parallel-structure dual-targeting CAR architecture of TPST-2003 is truly innovative, and fits perfectly within our experience supporting technology transfer of engineered cell therapy products, including our extensive experience making novel CAR-T programs IND-ready. We look forward to generating the information needed to advance TPST-2003 to the next stage of development."

About TPST-2003

TPST-2003 is an autologous CD19/BCMA dual-targeting CAR-T therapy designed to improve response depth and durability in patients with relapsed/refractory multiple myeloma (rrMM) through a parallel dual-targeting CAR structure designed to address tumor heterogeneity and antigen escape. TPST-2003 is being developed in China by Tempest’s partner, Novatim Immune Therapeutics ("Novatim"). Under its agreement with Novatim, Tempest has the exclusive right to develop TPST-2003 outside of China, India, Turkey, and Russia.

About REDEEM-1

REDEEM-1 (Study nos. CTR20233309/NCT06223646) is a Phase 1/2a clinical trial evaluating TPST-2003 in patients with relapsed/refractory multiple myeloma, including patients with high-risk cytogenetics and patients with extramedullary disease. The REDEEM-1 trial has a targeted full enrollment of 29 patients. The REDEEM-1 trial is sponsored and being conducted by Tempest’s partner, Novatim Immune Therapeutics, with a total of eight clinical sites registered in China: Peking Union Medical College Hospital (Dr. Jian Li; lead site), The First Affiliated Hospital of Nanchang University (Dr. Fei Li), Peking University First Hospital (Dr. Yujin Dong), Henan Cancer Hospital (Dr. Baijun Fang), Shanxi Provincial Cancer Hospital (Dr. Liping Su), The Second Xiangya Hospital of Central South University (Dr. Hongling Peng), The First Affiliated Hospital of China Medical University (Dr. Xiaojing Yan), and The Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College (Dr. Dehui Zou).

Additional clinical trials evaluating TPST-2003

A Phase 1/2 IIT (Study no. NCT04714827) is evaluating TPST-2003 in patients with relapsed/refractory multiple myeloma, including patients with high-risk cytogenetics and patients with extramedullary disease. The IIT is sponsored and being conducted by Tempest’s partner, Novatim Immune Therapeutics, with a total of two clinical sites registered in China: Shanghai Fourth People’s Hospital (Dr. Weijun Fu; lead site) and Shanxi Provincial Cancer Hospital (Dr. Liping Su).

A Phase 1 trial (Study nos. CTR20242409/NCT06518876) is evaluating TPST-2003 in patients with POEMS, a rare blood disorder caused by abnormal plasma cells. The Phase 1 trial is sponsored and being conducted by Tempest’s partner, Novatim Immune Therapeutics, with a total of three clinical sites registered in China: Peking Union Medical College Hospital (Dr. Jian Li; lead site), Xuanwu Hospital Capital Medical University (Dr. Wanling Sun), and West China Hospital, Sichuan University (Dr. Yu Wu).

(Press release, Tempest Therapeutics, MAR 11, 2026, View Source [SID1234663459])