On March 23, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) announced today it has entered into a definitive agreement to acquire Ouro Medicines, a privately held biotechnology company focused on developing T cell engager therapies for autoimmune diseases.

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The acquisition adds OM336 (gamgertamig), a clinical‑stage BCMAxCD3 T cell engager, to Gilead’s growing inflammation portfolio. OM336 is designed to enable rapid and deep B cell depletion following a limited subcutaneously administered treatment course. In ongoing Phase 1/2 clinical studies, OM336 has demonstrated transformative efficacy and a differentiated safety profile after a single treatment cycle in severe antibody-mediated orphan diseases including autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP). Gamgertamig has been granted both Fast Track and Orphan Drug Designation by the U.S. FDA for the treatment of AIHA and ITP and is expected to enter registrational studies in 2027.

"This acquisition underscores our commitment to advancing transformative therapies for people living with serious autoimmune diseases," said Dietmar Berger, MD, PhD, Chief Medical Officer of Gilead. "BCMA is a validated target with emerging data demonstrating potentially transformative outcomes in autoimmune diseases. BCMA targeted T cell engagers represent a differentiated approach with the potential to induce durable disease control. This novel framework complements our expanding inflammation pipeline and reflects our strategy to invest in innovative science that may redefine standards of care."

BCMA‑targeted T cell engagers are being investigated as a precision approach for severe inflammatory and autoimmune diseases by eliminating pathogenic B cells and plasma cells. By redirecting a patient’s own T cells toward BCMA‑expressing plasma cells, clinical data suggests these agents may reduce inflammation, improve organ‑level disease, and, in some cases, enable an immune reset marked by durable, drug‑free remission without ongoing immunosuppression. T cell engagers represent an important modality for patients alongside Gilead’s portfolio of CAR-T assets.

"From the outset, we saw the potential for gamgertamig to redefine the standard of care for immune-mediated diseases," said Jaideep Dudani, PhD, CoFounder and Chief Executive Officer of Ouro Medicines. "Since then, we’ve taken meaningful steps to advance that vision, with multiple trials now underway. With support from Gilead and Galapagos, we can build on the strong early foundation—leveraging a proven track record in late stage development, launch, and commercialization to accelerate our programs and help deliver on the promise gamgertamig holds for patients with immune-mediated diseases, following our initial collaboration with Keymed Biosciences."

Terms of the Transaction

Under the terms of the agreement Gilead will acquire all of the outstanding equity of Ouro Medicines for a total of $1,675 million in upfront cash consideration, subject to customary adjustments, which is payable at closing, and up to $500 million in contingent milestone payments. Closing of the transaction is subject to expiration or termination of certain regulatory filings and other customary conditions.

Strategic Collaboration with Galapagos

Gilead is currently in advanced discussions with Galapagos with respect to a potential research and development collaboration on the acquired Ouro Medicines assets. The arrangement between Gilead and Galapagos is contemplated to include the following key terms:

Galapagos would pay 50% of the upfront consideration and 50% of any contingent milestone payments payable to Ouro Medicines’ shareholders.
Galapagos would absorb substantially all of Ouro Medicines’ operating assets and retain its employees.
Gilead and Galapagos would collaborate on the development of OM336, with Galapagos responsible for development costs through initiation of registrational studies. Registrational study costs would be shared equally between the parties.
Gilead would retain sole worldwide commercialization rights (other than in Greater China where Keymed Biosciences has existing commercialization rights) and Gilead would pay Galapagos royalties of 20%-23% of net sales.
Amended legacy Galapagos Option License and Collaboration Agreement ("OLCA") to allow for up to $500 million of Galapagos’ current cash to be used freely by Galapagos, including up to $150 million for potential share repurchases.
Centerview Partners LLC and TD Cowen are acting as financial advisors to Gilead. Goldman Sachs & Co. LLC is acting as the exclusive financial advisor to Ouro Medicines. Morgan Stanley & Co., LLC is acting as financial advisor to Galapagos. Covington & Burling LLP, Mayer Brown LLP, and Arnold & Porter Kaye Scholer LLP are serving as legal counsel to Gilead. Goodwin Procter LLP is serving as legal counsel to Ouro Medicines. Paul Weiss LLP and Linklaters LLP are serving as legal counsel to Galapagos.

About OM336

OM336 is an investigational BCMAxCD3 bispecific T cell engager for the treatment of autoantibodies driven immune-mediated disease. OM336 has been granted Orphan Drug Designation and Fast Track Designation by the U.S. Food and Drug Administration for certain autoimmune diseases. OM336 is under an open IND in the U.S. and is expected to enter registrational studies in 2027. OM336 is in-licensed by Ouro Medicines from Keymed Biosciences, which owns the rights to develop the program in Greater China.

On March 23, 2026 Theriva Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported the outcomes of a recent Type B End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) regarding the design of a Phase 3 clinical study of lead clinical candidate VCN-01 in combination with standard-of-care chemotherapy for the treatment of metastatic pancreatic adenocarcinoma (PDAC).

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The FDA provided general agreement with Theriva’s proposed design for a Phase 3 clinical trial, which closely tracks the design of the successful VIRAGE Phase 2 trial. As announced in 2025, the VIRAGE trial met its primary endpoints, with metastatic PDAC patients receiving VCN-01 with SoC chemotherapy having improved overall survival (OS), progression free survival (PFS) and Duration of Response (DoR) compared to SoC chemotherapy alone. Greater improvements in OS and PFS were observed in patients who received two doses of VCN-01, leading Theriva to plan the Phase 3 trial to include repeat dosing and an adaptive design aimed to optimize the trial’s timelines and outcomes. .

Consistent with scientific advice previously received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the FDA advised that a potential biologics licensing application (BLA) for VCN-01 in metastatic PDAC could be supported by Theriva’s proposed Phase 3 clinical trial (if successful) comprising a single, high-quality, randomized, double-blinded, study comparing VCN-01 plus gemcitabine/nab-paclitaxel SoC to gemcitabine/nab-paclitaxel SoC plus placebo. The FDA further agreed on the proposed dosing of VCN-01 and gemcitabine/nab-paclitaxel in repeated "macrocycles" (enabling more than 2 doses of VCN-01 to be administered in the Phase 3 trial), the proposed inclusion/exclusion criteria, the primary endpoint (overall survival), key secondary endpoints (including progression free survival), and the use of an adaptive design. The FDA also clarified statistical expectations regarding the proposed interim analyses and the quality of data required for potential sample size re-estimation or a demonstration of early efficacy.

"We are very pleased to align with the FDA on the key elements of our proposed pivotal Phase 3 trial evaluating VCN-01 plus gemcitabine/nab-paclitaxel SoC in metastatic PDAC patients," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "Data from our VIRAGE Phase 2b study demonstrated improved outcomes in PDAC patients treated with 2 doses of VCN-01 and we believe that administering multiple macrocycles of VCN-01 and gemcitabine/nab-paclitaxel that may further improve patient outcomes. The combined feedback from the FDA and the EMA now enables us to finalize the protocol for a pivotal Phase 3 clinical trial and pursue development funding and/or partnerships, which, if successful, may deliver a novel and effective treatment option for patients with this difficult to treat solid tumor cancer."

About Pancreatic Ductal Adenocarcinoma

Cancer of the pancreas consists of two main histological types: cancer that arises from the ductal (exocrine) cells of the pancreas or, much less often, cancers may arise from the endocrine compartment of the pancreas. Pancreatic ductal adenocarcinoma ("PDAC") accounts for more than 90% of all pancreatic tumors. It can be located either in the head of the pancreas or in the body/tail. Pancreatic cancer usually metastasizes to the liver and peritoneum. Other less common metastatic sites are the lungs, brain, kidney, and bone. In its early stages, pancreatic cancer does not typically result in any characteristic symptoms. In many instances, progressive abdominal pain is the first symptom. Therefore, in most cases, pancreatic cancer is diagnosed in its late stages (locally advanced non-metastatic or metastatic stage of the disease) when surgical resection and possibly curative treatment is not possible. It is generally assumed that only 10% of cases are resectable at presentation, whereas 30-40% of patients are diagnosed at local advanced/unresectable stage and 50-60% present with distant metastases.

About VCN-01

VCN-01 is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to 142 patients to date in Company- and investigator-sponsored clinical trials of different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). More information on these clinical trials is available at Clinicaltrials.gov.

(Press release, , MAR 23, 2026, View Source [SID1234663838])

On March 23, 2026 Oncotelic Therapeutics, Inc. (OTCQB:OTLC) ("Oncotelic", the "Company" or "We" or "Our"), a leader in RNA-based therapeutics, reported that its subsidiary Sapu Nano will present new data on everolimus toxicology, focusing on tissue concentration-driven effects, at the upcoming Society of Toxicology (SOT) 2026 Annual Meeting and ToxExpo, taking place March 22-25, 2026, in San Diego, California.

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The presentation will be featured during the Poster Session: ADME/Toxicokinetics I:

Date: Monday, March 23, 2026
Time (Author Attended): 1:45 PM – 4:15 PM
Display Time: 9:00 AM – 4:30 PM
Location: Exhibit Hall B, San Diego Convention Center
Abstract #: 3539
Poster Board #: K692
Presentation Title:
"Everolimus Toxicology: Tissue Concentration Effects"

Authors:
W. Chang, N. Chang, T. Hoque, and C. Lee
Sapu Nano, San Diego, CA

This poster presents new findings that elucidate the relationship between tissue-level exposure of everolimus and organ-specific toxicological outcomes, advancing understanding beyond traditional plasma pharmacokinetics.

"These data underscore the importance of tissue pharmacokinetics in determining toxicity profiles for mTOR inhibitors such as everolimus," said Wen-Han Chang PhD, Sr. Manager Nanomedicine. "Our findings provide a foundation for developing improved delivery strategies, including intravenous and nanoparticle-based formulations that better control biodistribution."

The SOT Annual Meeting and ToxExpo is the leading international forum for toxicology, bringing together scientists from academia, industry, and regulatory agencies to present cutting-edge research in safety science and drug development.

Sapu Nano’s participation highlights its continued leadership in nanomedicine and advanced drug delivery, with a focus on enhancing therapeutic index through precise control of drug distribution at the tissue level.

For more information about the meeting, visit:
www.toxicology.org/2026 | #2026SOT | #ToxExpo

(Press release, Oncotelic, MAR 23, 2026, View Source [SID1234663837])

On March 23, 2026 Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing masked immuno-oncology therapies for people living with cancer, reported pipeline progress and business updates and reported financial results for the fourth quarter and full year ended December 31, 2025.

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"As we enter 2026, we are well-positioned to leverage our clinically validated masking technology to continue advancing our next generation of multi-specific I-O therapies toward the clinic," said René Russo, Pharm.D., president and chief executive officer of Xilio. "We are encouraged by the progress the field has recently made with masked T cell engagers for prostate cancer, and we are excited to be advancing a potential first-in-class multi-specific masked T cell engager targeting both PSMA and STEAP1 with built-in co-stimulatory signaling designed to enhance potency and durability of response. We believe that targeting both PSMA and STEAP1, which are the most prevalent tumor-associated antigens expressed in prostate cancer, will minimize resistance due to antigen escape. In addition, this quarter we continued to make strong progress advancing XTX501, our potential best-in-class bispecific PD-1 / masked IL-2, toward a planned IND submission mid-year."

Pipeline Progress and Business Updates

XTX501: bispecific PD-1 / masked IL-2

XTX501 is a novel bispecific PD-1 / masked IL-2 designed to selectively stimulate PD-1 positive, antigen-experienced T cells and enhance their function. XTX501 incorporates masking and is designed to overcome IL-2 receptor-mediated clearance, peripheral activity and tolerability issues associated with non-masked IL-2 agents. In preclinical studies, XTX501 demonstrated robust monotherapy activity (including in settings insensitive to PD-1 therapy) and tumor-selective pharmacodynamics consistent with its intended mechanism of action.

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Xilio is currently advancing XTX501 through investigational new drug (IND)-enabling studies and plans to submit an IND application for XTX501 in the middle of 2026.
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Xilio plans to initiate a Phase 1 trial for XTX501 in the second half of 2026 and report initial Phase 1 data in the second half of 2027, subject to clearance of the IND by the U.S. Food and Drug Administration.
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Xilio plans to initially evaluate XTX501 in patients with metastatic non-small cell lung cancer before expanding development to other solid tumor types, including tumors that are insensitive to PD-1 therapy. The company believes XTX501 also has the potential to be a foundational "backbone" therapy for combination treatment with other agents.

Masked T Cell Engager Programs

Xilio is leveraging its proprietary, clinically-validated masking technology to advance two wholly-owned programs for masked T cell engagers, as well as an additional program in collaboration with AbbVie Group Holdings Limited (AbbVie).

Xilio’s masked T cell engagers include molecules with one or more tumor-associated antigen (TAA) binding domains and a CD3 targeting domain, which are designed to release a potent, short half-life T cell engager upon tumor-selective activation (ATACR format), and molecules that include a co-stimulatory domain designed to further enhance potency and durability of the T cell response (SEECR format). Depending on the desired properties that Xilio is seeking to achieve for a particular molecule and TAA(s), Xilio’s modular architecture for its masked T cell engagers enables optionality to: include multiple TAA binding domains; add a co-stimulatory domain; and/or mask the CD3 targeting domain, TAA binding domain(s) and/or the co-stimulatory signaling domain.

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Xilio is advancing a wholly-owned masked T cell engager program targeting CLDN18.2 (ATACR format). Xilio’s modular design architecture for T cell engagers also enables flexibility to evaluate designs that incorporate masking of the CLDN18.2 binding domain and/or add a co-stimulatory domain (SEECR format) in parallel with advancing the current molecule design. CLDN18.2 is expressed in gastrointestinal cancers (including gastric, pancreatic and esophageal) and lung cancer.
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Xilio plans to present new preclinical data for its CLDN18.2 program in a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place from April 17-22, 2026 (abstract number: 1619).
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Xilio is advancing a wholly-owned multi-specific, masked T cell engager program targeting PSMA and STEAP1 with built-in co-stimulatory signaling (SEECR format). Xilio anticipates nominating a development candidate in the second quarter of 2026. PSMA and STEAP1 are expressed in most prostate cancer tumors, and targeting both of these TAAs has the potential to address tumor heterogeneity while minimizing the potential for resistance due to antigen escape.
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Xilio plans to advance these masked T cell engager programs into IND-enabling studies and submit IND applications for each of these programs in 2027.

Efarindodekin alfa: masked IL-12

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Xilio is evaluating efarindodekin alfa as a monotherapy in an ongoing Phase 2 clinical trial in patients with advanced solid tumors and expects to deliver an option data package to Gilead Sciences, Inc. (Gilead) in the first half of 2027.

Recent Corporate Updates

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In January 2026, Xilio announced the appointment of Sara Bonstein as chair of the board of directors.
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In January 2026, Xilio announced the receipt of $35.8 million in gross proceeds from the exercise of Series B warrants, before deducting underwriting discounts and commissions and any offering expenses, including the full exercise of Series B warrants held by Coastlands Capital, Frazier Life Sciences and Gilead. The Series B warrants were issued in connection with a follow-on offering in June 2025.
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In January 2026, Xilio announced the achievement of a development milestone related to the masked antibody-based immunotherapy program under the company’s collaboration, license and option agreement with AbbVie.

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In February 2026, Xilio closed a follow-on offering of prefunded warrants for $40.0 million in gross proceeds, before deducting underwriting discounts and commissions and any offering expenses. The offering was led by existing investor Coastlands Capital and included participation from OrbiMed, Perceptive Advisors and Gilead, as well as other new and existing institutional investors.

Year-End and Fourth Quarter 2025 Financial Results

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Cash Position: Cash and cash equivalents were $137.5 million as of December 31, 2025, compared to $55.3 million as of December 31, 2024. In the fourth quarter of 2025, Xilio received $35.8 million in gross proceeds from Series B warrant exercises and a $17.5 million development milestone payment under its license agreement with Gilead.
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Collaboration and License Revenue: Collaboration and license revenue was $13.7 million for the quarter ended December 31, 2025, compared to $1.7 million for the quarter ended December 31, 2024. Collaboration and license revenue was $43.8 million for the year ended December 31, 2025, compared to $6.3 million for the year ended December 31, 2024. The year-over-year increase was primarily driven by collaboration and license revenue recognized under the collaboration, license and option agreement and stock purchase agreement that Xilio entered into in February 2025 with AbbVie and an increase in collaboration and license revenue recognized under the license agreement with Gilead due to the achievement of a $17.5 million development milestone during the third quarter of 2025.
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Research & Development (R&D) Expenses: R&D expenses were $18.1 million for the quarter ended December 31, 2025, compared to $8.8 million for the quarter ended December 31, 2024. R&D expenses were $56.0 million for the year ended December 31, 2025, compared to $41.2 million for the year ended December 31, 2024. The year-over-year increase was primarily driven by manufacturing activities related to IND-enabling studies and preclinical development activities for XTX501, increased clinical development activities related to efarindodekin alfa, increased costs related to masked T cell engager programs and indirect research and development and increased personnel-related costs, which were partially offset by a decrease in costs related to vilastobart and XTX202.
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General & Administrative (G&A) Expenses: G&A expenses were $7.4 million for the quarter ended December 31, 2025, compared to $6.5 million for the quarter ended December 31, 2024. G&A expenses were $29.7 million for the year ended December 31, 2025, compared to $24.8 million for the year ended December 31, 2024. The year-over-year increase was primarily driven by an increase in professional and consulting fees, including legal fees and other professional costs, and an increase in personnel-related costs, which were partially offset by a decrease in costs related to directors’ and officers’ liability insurance.
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Net Income (Loss): Net income was $10.4 million for the quarter ended December 31, 2025, compared to a net loss of $13.1 million for the quarter ended December 31, 2024. Net loss was $35.0 million for the year ended December 31, 2025, compared to $58.2 million for the year ended December 31, 2024. The year-over-year decrease in net loss was primarily driven by increased collaboration and license revenue for the year ended December 31, 2025.

Cash Runway

Based on its current operating plans, Xilio anticipates that its existing cash and cash equivalents will be sufficient to enable it to fund its operating expenses and capital expenditure requirements through the end of 2027.

This estimate excludes any potential future milestone payments, option-related fees or other contingent payments under Xilio’s collaboration and partnership agreements with AbbVie and Gilead and excludes up to $36.2 million in additional gross proceeds in the second half of 2026 if all outstanding Series C warrants are exercised at their current exercise price.

(Press release, Xilio Therapeutics, MAR 23, 2026, View Source [SID1234663836])

On March 23, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) (the "Company"), a clinical-stage biotechnology company developing a pipeline of advanced CAR-T cell therapy product candidates to treat cancer, reported that it has entered into definitive agreements for the purchase and sale of an aggregate of 925,927 shares of common stock (or pre-funded warrant in lieu thereof), series A warrants to purchase up to 925,927 shares of common stock and short-term series B warrants to purchase up to 925,927 shares of common stock, at a combined purchase price of $2.16 per share of common stock (or $2.159 per pre-funded warrant in lieu thereof) and accompanying warrants in a private placement. The series A warrants and the short-term series B warrants will have an exercise price of $2.16 per share and will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares issuable upon exercise of the warrants (the "Stockholder Approval Date"). The series A warrants will expire five years from the later of the Stockholder Approval Date and the Effectiveness Date (as defined below) and the short-term series B warrants will expire twenty-four months from the later of the Stockholder Approval Date and the Effectiveness Date. The private placement is expected to close on or about March 23, 2026, subject to the satisfaction of customary closing conditions.

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

The gross proceeds from the offering are expected to be approximately $2 million, prior to deducting placement agent fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the series A warrants and the short-term series B warrants, if fully exercised on a cash basis, will be approximately $4 million. No assurance can be given that any of the series warrants will be exercised, or that the Company will receive cash proceeds from the exercise of the series warrants. The Company intends to use the net proceeds from the offering for working capital and other general corporate purposes.

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the securities issued in the private placement and shares of common stock underlying the warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Pursuant to a registration rights agreement with the investors, the Company has agreed to file a resale registration statement covering the securities described above (such date of effectiveness of the resale registration statement, the "Effectiveness Date").

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, Tempest Therapeutics, MAR 23, 2026, View Source [SID1234663835])