On January 12, 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 preliminary unaudited financial results for the fourth quarter and full year ended December 31, 2025.

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The Company anticipates fourth quarter 2025 revenues of approximately $13.2 million and full-year 2025 revenues of approximately $45.2 million. As of December 31, 2025, TriSalus estimates cash and cash equivalents of approximately $20.4 million.

"TriSalus continued to deliver strong commercial performance in the fourth quarter and exceeded our 2025 guidance of 50% annual revenue growth, underscoring the meaningful clinical adoption of our TriNav product suite and proprietary PEDD platform across a broad range of solid tumor indications," said Mary Szela, President and Chief Executive Officer of TriSalus. "We are pleased not only with our commercial execution but also with the sustained progress on our strategic initiatives, including expansion of the TriNav platform across multiple indications beyond the liver and deepening our engagement within the interventional radiology community. Looking ahead to 2026, we expect full-year revenues to be in a range of approximately $60 million to $62 million."

Projected Unaudited 2025 Fourth Quarter and Full-Year Financial Results

Preliminary revenue for the fourth quarter of approximately $13.2 million, compared to $8.3 million in the prior year, representing approximately 60% growth year-over-year and sequential quarterly growth of approximately 14%.
Preliminary revenue for the year of approximately $45.2 million for the year, compared to $29.4 million in the prior year, representing approximately 53% growth year-over-year.
Year-end cash and cash equivalents of approximately $20.4 million, compared to $22.7 million at the start of the fourth quarter, a reduction in cash and cash equivalents for the fourth quarter of 2025 of $2.3 million. This reflects continued strong revenue growth and focus on operational efficiency.
The preliminary financial results set forth above are unaudited, are based on management’s initial review of TriSalus Life Science’s results as of and for the year ended December 31, 2025, and are subject to revisions based upon TriSalus Life Science’s year-end closing procedures and the completion of the external audit of TriSalus Life Science’s year-end financial statements. Actual results may differ materially from these preliminary unaudited results as a result of the completion of year-end closing procedures, final adjustments and other developments arising between now and the time that TriSalus Life Science’s financial results are finalized. In addition, these preliminary unaudited results are not a comprehensive statement of TriSalus Life Science’s financial results for the year ended December 31, 2025, should not be viewed as a substitute for full, audited financial statements, prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the Company’s results for any future period. Accordingly, investors are cautioned not to place undue reliance on these preliminary unaudited results.

TriSalus Life Sciences expects to announce full-year 2025 financial results its during earnings conference call in March 2026.

(Press release, TriSalus Life Sciences, JAN 12, 2026, View Source [SID1234662003])

On January 12, 2026 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the company’s key 2026 milestones ahead of its presentation at J.P. Morgan’s 44th annual healthcare conference.

"2025 was marked by exceptional progress at Cogent Biosciences," said Andrew Robbins, President and Chief Executive Officer. "We reported positive results from all three pivotal trials of bezuclastinib in patients with GIST and Systemic Mastocytosis, submitted our first NDA for bezuclastinib in patients with NonAdvSM based on the strength of the SUMMIT data, and put ourselves in a very strong financial position entering the new year. During 2026, we will transform Cogent into a fully integrated commercial stage company with plans to launch bezuclastinib in the second half of the year. In addition, we are investing for the future and plan to submit INDs in 2026 for both our pan-KRAS inhibitor and recently announced JAK2 V617F inhibitor. Our plans are supported by a highly experienced team with proven launch experience backed by a strong balance sheet. We are poised for success and extremely excited about the meaningful impact we can have for patients."

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In 2026, Cogent plans to achieve the following milestones:

Bezuclastinib

Acceptance of the New Drug Application (NDA) for bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM) by the end of February 2026
Submit an NDA in April 2026 for bezuclastinib in patients with advanced Gastrointestinal Stromal Tumors (GIST) previously treated with imatinib based on the strength of the PEAK pivotal trial
Submit an NDA in 1H 2026 for bezuclastinib in patients with Advanced Systemic Mastocytosis (AdvSM) based on the strength of the APEX pivotal trial
Present detailed, updated clinical data from each of the three pivotal trials (SUMMIT, PEAK, APEX) at major medical meetings during 1H 2026
Commercialize bezuclastinib following potential FDA approval in 2H 2026
Pipeline

Submit Investigational New Drug (IND) applications for CGT1815, Cogent’s novel, selective pan-KRAS(ON) inhibitor and CGT1145, Cogent’s novel, selective JAK2 V617F inhibitor
Present clinical data on CGT4859, Cogent’s selective and potent FGFR 2/3 inhibitor, from its Phase 1/2 study in patients with alterations in FGFR2 or FGFR3
Complete dose escalation for both CGT4255, Cogent’s CNS-penetrant, selective mutant ErbB2 inhibitor, and CGT6297, Cogent’s selective PI3Kα inhibitor
Bezuclastinib Expanded Access Programs

Working with the FDA, Cogent has established active Expanded Access Programs for U.S. patients with GIST or SM who meet disease-specific criteria and could benefit from treatment with bezuclastinib or the combination of bezuclastinib and sunitinib. A growing number of investigational sites now offer access to the bezuclastinib EAPs. For more information please visit: View Source

New Leadership Appointment

Cogent also announced today that Abb Hayden has joined Cogent as Senior Vice President, Sales. Mr. Hayden joins Cogent with over 25 years of industry experience. Previously he served as Vice President of Commercial at Syndax Pharmaceuticals. While at Syndax, he played an integral part in building the commercial infrastructure leading the Field Sales, Marketing, and Clinical Education team to launch Revuforj and Niktimvo. Prior to Syndax, he held roles of increasing responsibility at Adaptive Biotechnologies, Onyx Pharmaceuticals, and Eli Lilly. Mr. Hayden is a graduate of the University of Central Arkansas.

J.P. Morgan Presentation Details

Cogent will participate in a presentation and Q&A session at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, beginning at 8:15 a.m. PT (11:15 a.m. ET). A live webcast will be accessible in the "Investors & Media" section of the company’s website, www.cogentbio.com, and will be archived for 30 days following the event.

Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Cogent also announced today that, on January 9, 2026, the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, approved the grant of "inducement" equity awards to five new employees under the company’s 2020 Inducement Plan with a grant date of January 9, 2026. The awards were approved in accordance with Listing Rule 5635(c)(4) of the corporate governance rules of the Nasdaq Stock Market. The employees received, in the aggregate, (i) nonqualified options to purchase 66,700 shares of Cogent common stock and (ii) 9,700 restricted stock units (RSUs). Each option has a 10-year term, an exercise price equal to the closing price of Cogent’s common stock on the grant date, and a 4-year vesting schedule with 25% vesting on the 1-year anniversary of the grant date and the remainder vesting in equal monthly installments over the subsequent 36 months, provided such employee remains employed through each such vesting date. The RSUs vest annually in equal installments over 4 years from the grant date, provided such employee remains employed through each such vesting date.

(Press release, Cogent Biosciences, JAN 12, 2026, View Source [SID1234661943])

On January 12, 2026 NMS Group (NMS), a global leader in oncological innovation, reported that the China’s National Medical Products Administration (NMPA) has granted approval to the Investigational New Drug (IND) application for its first-in-class, orally bioavailable PARP7-selective inhibitor, atamparib, enabling its clinical studies in patients with advanced solid tumors.

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The phase Ib/II clinical trial expected to start in the first quarter of 2026 is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of atamparib in patients with advanced solid tumors, with a focus on a promising new therapeutic sub-setting. The goal is to validate the molecule’s differentiated mechanism of action and its favorable safety and tolerability with more than 200 patients treated so far, both in late-line patients and in future combination with standard-of-care in earlier treatment settings.

"The IND approval in China represents a key strategic milestone for the development of atamparib," said Hugues Dolgos, CEO of NMS Srl. "Recent data generated across preclinical and clinical programs, along with the newly published mechanism of action, have enabled us to reposition this asset into a promising sizeable indication where we believe it can deliver meaningful clinical benefit."

"Conducting the study in China is expected to support atamparib global clinical development by enabling timely access to a clinically relevant patient population and facilitating the potential availability of new treatment options for patients in China and worldwide," said Dadong Li, CEO of NMS Shanghai. "This milestone marks an important step in advancing the development of atamparib and exploring its potential to expand treatment options for patients."

In parallel, NMS is advancing a dual inhibitor program currently in preclinical development, targeting PARP7 and another undisclosed target, which is expected to complement the clinical development strategy of atamparib and underscores the company’s commitment to building a differentiated portfolio of innovative therapeutic candidates.

(Press release, Nerviano Medical Sciences, JAN 12, 2026, View Source [SID1234661961])

On January 12, 2026 Moderna, Inc. (NASDAQ:MRNA) reported business updates and progress across its pipeline of mRNA medicines. Moderna enters 2026 with a focus on growing sales, launching new infectious disease products and delivering pivotal readouts across oncology, rare disease and infectious disease portfolios.

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"In 2025, we strengthened our commercial execution, successfully launched our third product, and continued to advance our mRNA pipeline. At the same time, we reduced our annual operating expenses by approximately $2 billion, significantly exceeding the financial cost reduction commitments we set at the start of the year," said Stéphane Bancel, Chief Executive Officer of Moderna. "We remain focused on our strategy to build a large seasonal vaccine franchise for at-risk populations, creating a strong cash engine to fund our next phase of innovation in oncology and rare disease. We expect this approach to support up to 10 percent revenue growth in 2026, as we further reduce costs, expand our commercial portfolio with approvals of additional seasonal vaccines, and anticipate multiple clinical data catalysts driven by our late-stage oncology pipeline."

The Company’s presentation will take place on Monday, January 12, 2026, at 4:30 p.m. PT/7:30 p.m. ET at the 44th Annual J.P. Morgan Healthcare Conference. A live webcast of both the presentation and the question-and-answer session will be available.

Summary of Financial Updates

2025 financial updates: Moderna expects 2025 revenue of approximately $1.9 billion (unaudited), $100 million above the midpoint of the $1.6 – $2.0 billion range communicated on the Company’s 3Q25 Earnings Call. The Company is also improving2025 expected GAAP operating expenses by $200 million to a range of $5.0 – $5.2 billion (unaudited). Cash, cash equivalents and investments at year-end 2025 were approximately $8.1 billion (unaudited), which includes a $0.6 billion draw down from our recently announced $1.5 billion term loan facility. Full financial details will be reported in connection with the Company’s Earnings Call on February 13, 2026.

2026 financial framework: Moderna reiterates its target of up to 10% revenue growth in 2026. The Company expects GAAP operating expenses of approximately $4.9 billion in 2026. Moderna expects to further reduce GAAP operating expenses to $4.2 – $4.6 billion in 2027, on the path to targeted cash breakeven in 2028.

Summary of Late-Stage Pipeline and Approved Product Milestones

Seasonal vaccines:

COVID vaccines: Moderna’s new COVID vaccine, mNEXSPIKE, is currently approved in the U.S., Canada and Australia. Moderna is expecting potential approvals of mNEXSPIKE in Europe, Japan and Taiwan in 2026.

RSV vaccine: Moderna’s RSV vaccine, mRESVIA, is in an ongoing Phase 3 heterologous revaccination study with data expected in 2026.

Seasonal flu vaccine: The Company has completed submissions for approval of mRNA-1010 in the U.S., Canada, Australia and Europe and expects potential approvals to begin in 2026.

Seasonal flu/COVID vaccine: The Company’s mRNA-1083 filing is under review with the European Medicines Agency (EMA). Moderna submitted for approval to Health Canada in 2025. The Company is awaiting further guidance from the U.S. FDA on refiling.

Norovirus vaccine: Moderna’s ongoing Phase 3 study of mRNA-1403 is enrolling a second Northern Hemisphere season (2025-2026) for additional case accruals, which will inform the timing of the Phase 3 readout. The Company expects an interim analysis in 2026.

Oncology therapeutics:

Intismeran autogene: The Company is advancing mRNA-4157 in collaboration with Merck, with eight total Phase 2 and Phase 3 clinical trials underway across multiple tumor types including melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma. In adjuvant melanoma, Moderna expects the five-year Phase 2b data in early 2026, and the Phase 3 data potentially in 2026.

mRNA-4359: Moderna’s Phase 1/2 study of mRNA-4359, an investigational wholly-owned cancer antigen therapy, is ongoing. The Phase 2 portion of the study includes cohorts in first-line metastatic melanoma, second-line+ metastatic melanoma and first-line metastatic NSCLC, and the Company expects a potential Phase 2 data readout in 2026.

Rare disease therapeutics:

Propionic acidemia (PA) therapeutic: The Company’s PA candidate, mRNA-3927, is in a registrational study and target enrollment has been reached. Moderna expects a potential data readout in 2026.

Methylmalonic acidemia (MMA) therapeutic: Moderna’s mRNA-3705 has been selected by the FDA for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program, with a registrational study expected to begin in 2026.

Corporate Updates:

Moderna announced it closed a five-year term loan facility for up to $1.5 billion of capital from Ares Management Credit Funds.

Moderna announced that the Coalition for Epidemic Preparedness Innovations (CEPI) will invest up to $54.3 million to support a pivotal Phase 3 clinical trial to help advance Moderna’s investigational mRNA-based H5 pandemic influenza vaccine candidate, mRNA-1018, to licensure.

Key 2026 Investor and Analyst Event Dates

Fourth Quarter and Fiscal Year 2025 Earnings Call: February 13, 2026

Analyst Day: November 12, 2026

Event Information

Moderna’s presentation will take place on Monday, January 12, 2026, at 4:30 p.m. PT/7:30 p.m. ET at the 44th Annual J.P. Morgan Healthcare Conference. A live webcast of both the presentation and the question-and-answer session will be available under "Events and Presentations" in the investor section of Moderna’s website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for at least 30 days following the presentation.

(Press release, Moderna Therapeutics, JAN 12, 2026, View Source [SID1234661977])

On January 12, 2026 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pipeline progress and outlined key anticipated milestones towards its first potential U.S. commercial launch under its "OnTarget 2026" operating plan.

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As part of this plan, Nuvalent anticipates the following 2026 milestones:

Commercial launch in the U.S. of zidesamtinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least 1 prior ROS1 tyrosine kinase inhibitor (TKI), pending U.S. Food and Drug Administration (FDA) review;
Submit data to FDA for potential indication expansion of zidesamtinib in TKI-naïve patients with advanced ROS1-positive NSCLC in the second half of 2026;
Submit a New Drug Application (NDA) for neladalkib in TKI pre-treated patients with advanced ALK-positive NSCLC in the first half of 2026;
Progress the ongoing ALKAZAR Phase 3 randomized, controlled trial of neladalkib for TKI-naïve patients with ALK-positive NSCLC;
Progress the ongoing HEROEX-1 Phase 1a/1b trial of NVL-330 for patients with advanced HER2-altered NSCLC; and,
Disclose a new development candidate by year-end 2026.
"Over the past two years, the Nuvalent team has seamlessly executed against our OnTarget 2026 operating plan towards our goal of a first potential FDA approval, ending 2025 with the recent FDA acceptance of our NDA for zidesamtinib in TKI pre-treated ROS1-positive NSCLC and commercial preparedness activities well underway," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "If zidesamtinib is approved, a first commercial launch in 2026 would be a transformative moment for Nuvalent and the first step towards realizing our mission of becoming a sustainable company capable of not only discovering and developing, but delivering new medicines for patients with cancer."

"With cash runway anticipated into 2029, our strong financial position enables us to focus on the execution of a first U.S. launch while also supporting the continued advancement and expansion of both our commercial and development portfolios," said Alexandra Balcom, Chief Financial Officer at Nuvalent. "We have completed a pre-NDA meeting with the FDA for our ALK program and plan to move forward with an NDA submission of the data for TKI pre-treated patients with ALK-positive NSCLC from our ALKOVE-1 study of neladalkib in the first half of this year. In the second half of the year, we anticipate submitting data to support a potential indication expansion for zidesamtinib in ROS1-positive NSCLC, and growing our discovery portfolio with a new development candidate. Together, we believe the achievement of these anticipated 2026 milestones would position Nuvalent for continued, long-term growth driven by delivering meaningful impact for patients with NSCLC and beyond."

2025 Year-End Cash and Guidance

Nuvalent ended 2025 with approximately $1.4 billion in cash, cash equivalents and marketable securities (unaudited), which, based on its current operating plans, is expected to fund its operations into 2029. This amount is a preliminary, unaudited estimate only as of today, could change following completion of year-end closing procedures, and does not present all information necessary for an understanding of the company’s financial position as of December 31, 2025.

Presentation at 44th Annual J.P. Morgan Healthcare Conference

Dr. Porter will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 13, 2026 at 9:00 a.m. PT. A live webcast will be available in the Investors section of Nuvalent’s website at www.nuvalent.com, and will be archived for 30 days following the conference.

About Zidesamtinib
Zidesamtinib is an investigational, brain-penetrant, ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R. In addition, zidesamtinib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy.

Based on results for tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) enrolled in the global registrational ARROS-1 Phase 1/2 clinical trial, the U.S. Food and Drug Administration (FDA) has accepted for filing Nuvalent’s NDA submission for zidesamtinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who received at least 1 prior ROS1 TKI. The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026. Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic NSCLC who have been previously treated with 2 or more ROS1 TKIs and orphan drug designation for ROS1-positive NSCLC.

About Neladalkib
Neladalkib is an investigational, brain-penetrant, ALK-selective inhibitor created with the aim to overcome limitations observed with currently available ALK inhibitors. Neladalkib is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with single or compound treatment-emergent ALK mutations such as G1202R. In addition, neladalkib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and to drive deep, durable responses for patients across all lines of therapy. Neladalkib has received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ALK tyrosine kinase inhibitors and orphan drug designation for ALK-positive NSCLC.

About NVL-330
NVL-330 is an investigational, brain-penetrant, HER2-selective tyrosine kinase inhibitor designed to address the combined medical need of treating HER2-mutant tumors, including those with HER2 exon 20 insertion mutations, avoiding treatment related adverse events due to off-target inhibition of wild-type EGFR, and treating brain metastases.

(Press release, Nuvalent, JAN 12, 2026, View Source [SID1234661993])