On February 19, 2026 Pilatus Biosciences Inc., a biopharmaceutical company developing novel metabolic checkpoint immunotherapies for liver and gastrointestinal cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for PLT012, the company’s first-in-class anti-CD36 monoclonal antibody for the treatment of hepatocellular carcinoma (HCC). Pilatus is also developing PLT012 in additional solid tumor indications.

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FDA Fast Track designation is intended to facilitate the development and expedite the review of therapies that treat serious conditions and address unmet medical needs. The designation enables more frequent interactions with the FDA and potential eligibility for rolling review, priority review, and accelerated approval pathways.

PLT012 is a first-in-class metabolic checkpoint antibody designed to block CD36-mediated lipid uptake and immune suppression within the tumor microenvironment. CD36 is an immune-metabolic regulator highly expressed on exhausted T cells, NK cells, regulatory T cells, and tumor-associated macrophages, but far less prevalent in healthy tissues. By targeting CD36, PLT012 is engineered to invigorate innate and adaptive effector cells, reduce immunosuppressive cell populations, and promote stronger anti-tumor immune responses.

"Receiving FDA Fast Track designation for PLT012 is an important milestone that reinforces the potential of our checkpoint therapy approach to transform the treatment of HCC," said Raven Lin, Ph.D., Co-Founder and CEO, Pilatus Biosciences. "PLT012 was designed to address the metabolic adaptations that drive immune evasion in cancer. With IND clearance already secured and our Phase 1 trial open for patient enrollment, this designation will help accelerate clinical development and advance towards delivering a novel therapeutic option for patients, both in HCC and other solid tumors where patients do not benefit from existing immunotherapies."

The Phase 1 study (NCT07337525) is currently open for patient enrollment at clinical sites in Dallas and Houston, Texas. The study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary signs of clinical activity, with expansion cohorts planned for tumor types strongly influenced by CD36-mediated metabolic dysregulation. In preclinical models, PLT012 demonstrated monotherapy activity across both immune-inflamed and immune-excluded tumors and showed potential synergy with PD-1/PD-L1 inhibitors, supporting development as both a single agent and a combination therapy.

"Targeting CD36 represents a promising new way to reshape the tumor microenvironment. Importantly, we also start to reveal its superior activity on treating metabolic disorders. The fast track represents the beginning of an exciting chapter for Pilatus Biosciences," said Prof. Ping-Chih Ho, Chair of Scientific Advisory Board and Co-founder at Pilatus Biosciences. "Importantly, PLT012 has the potential to redefine how we approach the MASH-to-HCC continuum by intervening at the metabolic root of disease to treat and prevent progression."

Pilatus has also received FDA Orphan Drug Designation for PLT012 for the treatment of liver and intrahepatic bile duct cancers.

Beyond oncology, PLT012’s mechanism of action may also address upstream drivers of liver disease progression. By targeting CD36-mediated lipid uptake, PLT012 has demonstrated promising preclinical activity in metabolic dysfunction-associated steatohepatitis (MASH), including reductions in inflammation and fibrosis. By addressing the full disease continuum, from early hepatic dysfunction to advanced malignancy, PLT012 is well-positioned to intervene at the metabolic root of disease and potentially slow or halt progression.

About PLT012

PLT012 is a humanized monoclonal antibody designed to selectively block CD36-mediated lipid uptake, a key mechanism driving immunosuppression and immune exclusion within the tumor microenvironment. By targeting lipid metabolism, PLT012 exerts a unique mechanism of action: it reduces immunosuppressive cell populations, including Tregs and pro-tumor macrophages, while simultaneously enhancing anti-tumor activities of intratumoral NK cell and cytotoxic CD8+ T cell that are otherwise susceptible to lipid-induced exhaustion. In preclinical studies, PLT012 has demonstrated potent monotherapy efficacy in models of liver malignancies, with a favorable safety profile across species. Leveraging its distinct mechanism of action, PLT012 further acts as a potent sensitizer in combination with anti–PD-L1 therapies, effectively overcoming drug resistance in immune "cold" tumors and liver metastases.

(Press release, Pilatus Biosciences, FEB 19, 2026, View Source [SID1234662807])

On February 19, 2026 TriSalus Life Sciences, Inc. (Nasdaq: TLSI) ("TriSalus" or the "Company"), an oncology focused medical technology company advancing novel drug delivery technologies alongside standard-of-care therapies to improve outcomes for patients with solid tumors, reported that it intends to offer to sell shares of its common stock in an underwritten public offering. All of the shares to be sold in the offering are to be sold by TriSalus. In addition, TriSalus intends to grant the underwriters a 30-day option to purchase up to 15% of the total number of shares of common stock sold in the offering, on the same terms and conditions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Lake Street Capital Markets is acting as the sole book-runner for the proposed offering.

The shares are being offered and sold by the Company pursuant to an effective shelf registration statement on Form S-3 (File No. 333-291509) previously filed with the U.S. Securities and Exchange Commission (the "SEC") on November 13, 2025 and declared effective by the SEC on December 4, 2025. The offering of such shares is being made only by means of a prospectus supplement that forms a part of the registration statement. A preliminary prospectus supplement and accompanying base prospectus relating to the offering has been or will be filed with the SEC and will be available for free on the SEC’s website at View Source When available, copies of the preliminary prospectus supplement and the accompanying base prospectus relating to the offering may be obtained from Lake Street Capital Markets, LLC at 121 South Eighth Street, Suite 1000, Minneapolis, MN 55402, or e-mail at [email protected]. The final terms of the proposed offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, TriSalus Life Sciences, FEB 19, 2026, View Source [SID1234662806])

On February 19, 2026 Ten63 Therapeutics, an advanced AI drug-discovery company, reported that it added strategic investment from new investors Chugai Venture Fund and the Gates Foundation, bringing the Company’s total funding to over $45M.

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"We are very impressed with Ten63’s AI drug discovery platform and its ability to quickly and accurately simulate trillions of potential drugs," said John Gustofson, President and Head of Chugai Venture Fund. "However, this is not just about making drug discovery faster. It’s about creating medicines for targets no one else can and designing better alternatives where existing drugs deliver inadequate results."

The increased funding will fuel the advancement of Ten63’s proprietary computational drug discovery platform, BEYOND. BEYOND is the world’s first Large Quantum Chemistry Model (LQCM), delivering precise quantum-mechanics level simulations that are orders of magnitude faster than other cutting-edge computational approaches. The company says BEYOND enables the pursuit of previously undruggable targets, which correspond to 80% of all proteins in the human body. Ten63 has multiple programs showing its platform can overcome previously intractable problems. One such program focuses on Myc, one of the most-studied oncogenes, which has long been considered undruggable and is believed to drive 70% of all cancers. Despite hundreds of attempts spanning 40 years, it remains elusive. With the mathematical breakthroughs behind BEYOND, Ten63 has Myc-targeting therapeutics in active development that surpass all previous attempts at Myc inhibition.

"AI not only accelerates drug discovery; it enables us to pursue high-impact targets in ways that were previously impossible. Many of the most important targets across multiple diseases are considered undruggable. These critical targets are data-poor and difficult to reach experimentally. Making them exceptionally difficult for traditional experimental screening and current AI techniques. They require a new approach," said Marcel Frenkel, PhD, CEO of Ten63 Therapeutics.

Powered by BEYOND, the company is pursuing a pipeline of first- and best-in-class small molecules against some of the most impactful oncology targets. The company is focused on high-impact, but thus far undruggable or underdrugged disease targets.

Frenkel continued, "By perfecting a simulation environment that enables AI to explore and learn from trillions of molecular possibilities, millions of times faster than physical methods, while retaining experimental-level accuracy, we are advancing towards superintelligence for drug discovery. At that point, we believe little will remain undruggable."

New investors, the Gates Foundation and Chugai Venture Fund, RYSE, K5 Global, SF Holdings, Duke Capital Partners, Cape Fear BioCapital, Black Opal Ventures, and Panorama, joined Ten63’s existing syndicate, including Hatteras Venture Partners, Yosemite, Morpheus Ventures, Alexandria Venture Investments, and Draper Associates, in the latest funding round.

In connection with the financing, Mike Dial, Ph.D., Managing Director of Chugai Venture Fund, joined Ten63’s board of directors.

Coordinated Global Effort
In connection with the investment, Ten63 also received a grant from the Gates Foundation to support a global strategy to address one of the deadliest cancers worldwide: cervical cancer.

Human papillomavirus (HPV) is the most common sexually transmitted infection in the world. Some strains of HPV are high-risk and can lead to cancers, like cervical, vulvar, and vaginal cancers. Each year, HPV causes cancer in more than 650,000 women and men. Early detection and treatment of precancerous cells can prevent this from happening. Ten63’s BEYOND platform is being used to develop cost-effective and safe treatments for HPV lesions worldwide by tackling the viral proteins that lead to cancer and have so far been undruggable.

"The enthusiasm and momentum behind this new funding validates what we’ve believed from the beginning," says Clay Thorp, Ten63 Chairman of the Board and General Partner at Hatteras Venture Partners "Ten63’s approach has the potential to transform not just cancer treatment, but the entire spectrum of drug discovery."

(Press release, Ten63 Therapeutics, FEB 19, 2026, View Source [SID1234662805])

On February 19, 2026 Compugen Ltd. (NASDAQ: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational drug target discovery powered by AI/ML, reported that management will participate in the following upcoming investor conferences:

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Oppenheimer 36th Annual Healthcare Life Sciences Conference
Date: Thursday, February 26, 2026
Location: Virtual
Format: Fireside chat and 1×1 meetings
Fireside chat time: 2 PM ET

Leerink Partners 2026 Global Healthcare Conference
Date: Monday, March 9, 2026
Location: Miami, Florida, U.S.
Format: Fireside chat and 1×1 meetings
Fireside chat time: 8:40 AM ET

Live webcasts of the fireside chats will be available on the events page of the Investor Relations section of Compugen’s website at www.cgen.com. Replays will be available following the live events.

(Press release, Compugen, FEB 19, 2026, View Source [SID1234662804])

On February 19, 2026 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported business and financial results for the fourth quarter and full year 2025 and provided business updates.

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Fourth quarter total revenue grew 14% year-over-year to $43.6 million, and U.S. Galleri revenue grew 31% year over year to $41.3 million. Net loss was $99.2 million, which includes amortization of Illumina acquisition-related intangible items of $34.6 million. Gross loss was $11.1 million. Non-GAAP adjusted gross profit was $23.1 million, and non-GAAP adjusted EBITDA was $(71.8) million.1

For the full year total revenue grew 17% year over year to $147.2 million, and U.S. Galleri revenue grew 26% year over year to $136.8 million. Net loss was $408.4 million, which includes amortization of Illumina acquisition-related intangible items of $138.3 million and intangible assets impairment of $28.0 million. Gross loss was $62.6 million. Non-GAAP adjusted gross profit was $73.6 million, and non-GAAP adjusted EBITDA was $(320.6) million.

"2025 was a year of significant commercial growth for GRAIL, and we’re excited by the building momentum for multi-cancer early detection. In the fall, we presented positive results from the first ~25,000 participants in the PATHFINDER 2 study, and we subsequently raised more than $435 million, which provides financial flexibility as we continue to drive towards broad access for Galleri," said Bob Ragusa, Chief Executive Officer at GRAIL. "Our teams completed Galleri’s PMA submission to the FDA in January. And today, we announced topline results for the NHS-Galleri trial and completion of the analysis of the full 35k participant PATHFINDER 2 study. We remain on track for continued commercial growth in 2026 with new and expanding partnerships in digital health and further integration into health systems. We anticipate presenting detailed results from both PATHFINDER 2 and the NHS-Galleri trial in mid-2026."

For the three months ended December 31, 2025, as compared to the three months ended December 31, 2024, GRAIL reported:

Revenue: Total revenue, comprised of screening and development services revenue, was $43.6 million, an increase of $5.3 million or 14%.
Net loss: Net loss was $99.2 million, an increase of $2.1 million or 2%.
Gross loss: Gross loss was $11.1 million, an improvement of $4.8 million or 30%.
Adjusted gross profit1: Adjusted gross profit was $23.1 million, an increase of $5.2 million or 29%.
Adjusted EBITDA1: Adjusted EBITDA was $(71.8) million, an improvement of $12.2 million or 15%.
For the twelve months ended December 31, 2025, as compared to the twelve months ended December 31, 2024, GRAIL reported:

Revenue: Total revenue, comprised of screening and development services revenue, was $147.2 million, an increase of $21.6 million or 17%.
Net loss: Net loss was $408.4 million, an improvement of $1.6 billion or 80%.
Gross loss: Gross loss was $62.6 million, an improvement of $15.4 million or 20%.
Adjusted gross profit1: Adjusted gross profit was $73.6 million, an increase of $15.8 million or 27%.
Adjusted EBITDA1: Adjusted EBITDA was $(320.6) million, an improvement of $163.0 million or 34%.
Cash position: Cash, cash equivalents, and short-term marketable securities totaled $904.4 million as of December 31, 2025.

Additional business highlights include:

Announced topline results from the landmark, randomized, controlled NHS-Galleri trial, which evaluated annual screening with the Galleri test in England’s National Health Service (NHS) over three years in 142,000 demographically representative participants aged 50 to 77. The results show that adding Galleri to standard of care screening resulted in a substantial reduction in Stage IV cancer diagnoses, increased Stage I and II detection of deadly cancers, and four-fold higher cancer detection rate when compared to standard of care alone. While there was a trend towards reduction in combined Stage III and IV, the trial did not meet the primary endpoint of a statistically significant reduction.

Completed analysis of the full 35,000 participant PATHFINDER 2 study, demonstrating performance consistent with the 25,000 patient analysis presented in October and a strong safety profile. Full data from this study will be submitted for presentation at a conference later this year.

The Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R 842 / S.339) became federal law, establishing a Medicare coverage pathway for multi-cancer early detection tests.

Completed submission of the final module of the Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Galleri in January. The PMA submission is focused on test performance and safety results from 25,490 consented participants in the U.S.-based PATHFINDER 2 study with one year of follow up and from the prevalent screening round (first year) of the NHS-Galleri trial, the largest, and only, randomized, controlled intended use trial of any multi-cancer early detection (MCED) test. The submission is also supported by a bridging analysis to compare performance of the version of Galleri used in registrational trials to the updated version that has been submitted to the FDA for premarket approval.

Expanded access to Galleri through digital health platforms with the launch of the Hims & Hers Multi-Cancer Test by Galleri. The availability of Galleri through Hims & Hers Labs platform is additive to access provided through other leading digital health and wellness platforms including Function Health and Everlywell.
Conference Call and Webcast
A webcast and conference call will be held today, February 19, 2026, at 2:00 p.m. PT / 5:00 p.m. ET. Individuals interested in listening to the conference call may access it on the investor relations section of GRAIL’s website at investors.grail.com.

(Press release, Grail, FEB 19, 2026, View Source [SID1234662803])