On November 13, 2025 TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the "Company"), an oncology company integrating novel delivery technology with standard of care therapies, and its investigational immunotherapeutic to transform treatment for patients with solid tumors, reported financial results for the quarter ended September 30, 2025, and provides an operation update.

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"TriSalus continued to deliver strong commercial performance in the third quarter, underscoring the growing clinical adoption of our TriNav product suite and proprietary PEDD platform across a broad range of solid tumor indications," said Mary Szela, President and CEO of TriSalus. "We are pleased to reaffirm our full-year revenue growth guidance of 50%, reflecting the increasing market penetration of TriNav for liver-directed therapies. We continue to invest in registry and other clinical programs and are committed to building a data-driven case for the expansion of our PEDD technology platform to new embolization applications. With our strategic shift toward partnering development of nelitolimod, we are also reducing our quarterly cash burn even as we extend our platform. Our three PERIO clinical phase 1 dose escalation studies are completed, with clinical study reports under preparation for data release in Q4. We look forward to the balance of 2025 energized by our long-term vision of bringing our PEDD technology to a wider range of patients and improving their clinical outcomes."

Third Quarter 2025 Operational Highlights

Generated $11.6 million in net sales, a 57% increase year-over-year, and sequential growth of 3% over the second quarter 2025.
Lowered quarterly cash burn by approximately 50% quarter-over-quarter.
Delivered strong commercial performance, with expanding use of TriNav in liver embolization, and continued further development of new applications for new clinical settings focused on the interventional radiology call point.
Simplified the Company’s capital structure through successful completion of an exchange offering of previously issued Series A Preferred stock.
Investigator-published study in the Journal of the Endocrine Society includes results of a retrospective single-center study by Gad et al. which evaluated the safety, feasibility, and early efficacy of Pressure-Enabled Thyroid Artery Embolization (PED-TAE) using the TriNav Infusion System. This novel, minimally invasive technique targets the inferior thyroid arteries to reduce gland size and alleviate symptoms in patients who are not candidates for surgery or conventional therapies. These early results lay the foundation for a broader evaluation of pressure-enabled embolization in the management of benign thyroid disease,"
Initiated a clinical trial to evaluate genicular artery embolization (GAE) as a potential treatment for knee osteoarthritis, a condition affecting more than 30 million adults in the United States. The study aims to assess whether GAE can reduce pain and delay the need for knee replacement surgery.
Third Quarter 2025 Financial Results

Revenue, all from sales of the TriNav system, was $11.6 million for the three months ended September 30, 2025, an increase of 57% compared to the same period in 2024 and 3% sequential growth. Revenue growth was driven primarily by increased TriNav sales within liver directed applications.
Gross margins were 84% in the third quarter, compared to 86% in the same period of 2024. The year-over-year decline was primarily driven by lower manufacturing efficiency associated with newly launched products, a dynamic we continue to expect to improve as production scales and processes mature over the course of the year.
Research and Development (R&D) expenses were approximately $5.2 million, compared to $4.2 million for the same quarter of the prior year. The increase was primarily due to a one-time charge of approximately $2.1 million related to closing of our clinical studies related to nelitolimod, partially offset by the revision of approximately $0.7 million in patent-related costs to general and administrative expenses.
Sales and Marketing (S&M) expenses were approximately $6.8 million in the third quarter, compared to $6.1 million for the same quarter of the prior year. The year-over-year increase was primarily due to an increase in performance related compensation driven by the increase in sales.
General & Administrative (G&A) expenses for the third quarter were approximately $6.7 million, compared to $4.7 million for the same quarter of the prior year. The increase was primarily driven by the acceleration of approximately $1.6 million in non-cash stock-based compensation and the revision of approximately $0.7 million in patent-related expenses from research and development to general and administrative.
Operating losses were $9.0 million, compared to Operating losses of $8.7 million for the same period in the prior year. The increase was primarily driven by a one-time charge related to the close out of our clinical studies along with a one-time acceleration of non-cash stock based compensation related awards.
Net loss attributable to common stockholders was $41.3 million in the third quarter, compared to $3.2 million for the same period in the prior year, primarily driven by the conversion of our preferred stock to common stock during the third quarter of 2025, resulting in approximately $30.5 million net loss attributable to common stockholders.
The basic and diluted loss per share was $0.96 for the third quarter, compared to $0.12 for the same period in 2024. This is primarily due to the conversion of preferred stock to common stock.
As of September 30, 2025, cash and cash equivalents totaled $22.7 million providing sufficient runway to reach positive adjusted EBITDA.
The non-GAAP measure of adjusted EBITDA is reconciled in the table below as the Company believes it is an important measure of performance. Adjusted EBITDA losses were $5.4 million, compared to losses of $7.2 million for the same period in 2024. Adjusted EBITDA for the period includes approximately $2.1 million of a charge related to closing the clinical studies related to Nelitolimod. Currently, reductions in adjusted EBITDA losses are due to increased sales, reduced research and development expenses and increased stock compensation in 2025.

Conference Call

The Company will host a conference call and webcast today, November 13, 2025 at 4:30 PM eastern time to discuss its financial results for the quarter ended September 30, 2025. Parties interested in participating by phone should register using this online form. After registering for the webcast, dial-in details will be provided in an auto-generated e-mail containing a link to the conference phone number along with a personal pin. The event will also be webcast live on the investor relations section of TriSalus’ website. A replay will also be available on the website following the event.

(Press release, TriSalus Life Sciences, NOV 13, 2025, View Source [SID1234659938])

On November 13, 2025 PAVmed Inc. (NASDAQ: PAVM) ("PAVmed" or the "Company"), a diversified commercial-stage medical technology company, operating in the medical device, diagnostics, and digital health sectors, reported a business update for the Company and its subsidiaries, Lucid Diagnostics Inc. (NASDAQ: LUCD) ("Lucid") and Veris Health Inc. ("Veris"), and reported financial results for the quarter ended September 30, 2025.

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Conference Call and Webcast

The webcast will take place on Thursday, November 13, 2025, at 8:30 AM and is accessible in the investor relations section of the Company’s website at pavmed.com. Alternatively, to access the conference call by telephone, U.S.-based callers should dial 1-800-836-8184 and international listeners should dial 1-646-357-8785. All listeners should provide the operator with the conference call name "PAVmed Business Update" to join.

Following the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company’s website at pavmed.com.

Business Update Highlights

"Over the past 18 months, we have taken decisive steps to stabilize PAVmed’s corporate structure and strengthen its balance sheet, and we believe we are entering the final stages of that process," said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer. "As our subsidiaries continue to execute and advance toward major milestones, we expect PAVmed to benefit directly from their success. Veris is progressing toward FDA submission of its implantable physiological monitor, expanding its partnership with OSU-The James, and developing new value-add capabilities beyond remote patient monitoring. Lucid remains firmly on track as it approaches transformative Medicare coverage for EsoGuard, supported by a strengthened balance sheet, continued commercial execution, and a new world-class market access team driving payor engagement. We also signed a letter of intent with Duke University to license a promising endoscopic imaging technology, adding another potential growth engine to our innovation pipeline."

Highlights from the third quarter and recent weeks:

Veris launched commercial phase of strategic partnership with The Ohio State University James Cancer Hospital, advancing deployment of the Veris Cancer Care Platform.
Veris fully relaunched implantable physiological monitor development in preparation for a planned 2026 FDA 510(k) submission.
Veris completed a long-term strategic partnership with The Ohio State’s James Cancer Hospital. Integration with the hospital’s electronic health record (EHR) system is now in process, with full commercial deployment of the Veris Cancer Care Platform to commence thereafter.
Veris continued executing on its expanded vision, focusing on commercial expansion and value-add offerings beyond remote patient monitoring (RPM), including clinical support services and AI-based clinical decision tools such as risk stratification.
PAVmed signed a letter of intent to license, through a newly formed subsidiary, groundbreaking endoscopic esophageal imaging technology, as it continues to evaluate new opportunities to leverage its shared services model across diverse sectors.
Lucid Diagnostics announced third quarter 2025 financial results and key business developments, including:
Recognized $1.2 million in EsoGuard Esophageal DNA Test revenue for 3Q25 and processed 2,841 EsoGuard tests.
Medicare Contractor Advisory Committee (CAC) meeting held where medical experts unanimously supported Medicare coverage for EsoGuard.
Strengthened balance sheet with underwritten public offering of common stock, netting approximately $27.0 million in proceeds.
Recruited world-class market access team focused on payor engagement, broad insurance coverage, and patient access.
Financial Results:

For the three months ended September 30, 2025, Operating expenses were approximately $4.8 million which include stock-based compensation expenses of $0.4 million. GAAP net loss attributable to common stockholders was approximately $6.3 million, or $(0.29) per common share on a diluted basis.
As shown below and for the purpose of illustrating the effect of stock-based compensation and other non-cash income and expenses on the Company’s financial results, the Company’s non-GAAP adjusted loss was approximately $0.4 million or $(0.02) per common share.
PAVmed had cash and cash equivalents of $3.1 million as of September 30, 2025, compared to $1.2 million as of December 31, 2024.
The unaudited financial results for the three and nine months ended September 30, 2025 were filed with the SEC on Form 10-Q on November 12, 2025, and are available at www.pavmed.com or www.sec.gov.

(Press release, PAVmed, NOV 13, 2025, View Source [SID1234659937])

On November 13, 2025 Taiho Oncology, Inc., a company developing and commercializing novel treatments for hematologic malignancies and solid tumors, reported the presentation of new data from 14 studies across company-sponsored and company-funded externally led studies at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, to be held Dec. 6-9, 2025, in Orlando, Florida.

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Taiho Oncology will share findings from clinical trials in two oral presentations and evidence from real-world studies in two online abstracts.

The oral presentations will highlight results from the Phase 2 part of ASTX030-01, a randomized, open-label, crossover trial comparing oral combination of azacitidine and cedazuridine to subcutaneous azacitidine and the Phase 2 portion of the Phase 1/2 trial ASTX727-03 of low-dose versus standard-dose oral decitabine and cedazuridine in patients with lower-risk myelodysplastic syndromes (MDS).
The two online posters will present real-world data on U.S. adults with acute myeloid leukemia (AML), describing treatment patterns and outcomes with hypomethylating agent (HMA) plus venetoclax, and evaluating the time burden of initiating parenteral HMA-based therapy in routine practice.
Additionally, 10 presentations – including four oral presentations – led by independent investigators will feature data from Taiho-funded investigator-initiated or collaborative studies. These presentations will highlight:

Results from a UK multicenter Phase 2 randomized trial comparing ASTX727 with hydroxycarbamide or best supportive care in advanced MDS/ myeloproliferative neoplasm (MPN).
Data from a Phase 2 study evaluating the all-oral combination of ASTX727, venetoclax and revumenib in newly diagnosed AML patients with NPM1m, KMT2Ar or NUP98r AML mutations.
Results of a Phase 1/2 clinical trial of the combination of oral decitabine/cedazuridine with the venetoclax in patients with untreated high-risk MDS and chronic myeloid leukemia (CMML).
Safety and efficacy results from a Phase 1/2 trial evaluating an all-oral combination of ASTX727, venetoclax and gilteritinib in both relapsed refractory and newly diagnosed FLT3-mutated AML, high-risk MDS or MPN.
"As the leader of oral HMA development, we’re excited that these data will be featured in six oral presentations at the ASH (Free ASH Whitepaper) Annual Meeting," said Harold Keer, MD, PhD, Taiho Oncology Chief Medical Officer. "These data highlight our increasing understanding of novel oral regimens in hematology. We are invested in developing treatments that have the potential to improve flexibility and lower the treatment burden for patients, and collaborating with leading institutions, evidenced by our continued support of independent clinical research to advance cancer care. We look forward to participating in the essential scientific exchange that contributes to progress in hematology at the ASH (Free ASH Whitepaper) Annual Meeting."

Data being presented by Taiho Oncology and its partners at the 2025 ASH (Free ASH Whitepaper) Annual Meeting and Exposition include:

Company-Sponsored Studies

Oral Presentations

Title: A phase 2 dose confirmation trial of oral ASTX030, a combination of oral azacitidine with cedazuridine among patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, and acute myeloid leukemia
Abstract Number: 491
Session Name: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Moving the Needle Through Novel Approaches in MDS and CMML
Session Date: Dec. 7, 2025
Session Time: 9:30 a.m. to 11a.m.
Presentation Time: 10:15 to 10:30 a.m.
Location: OCCC – Valencia Room W415D
Presenter: Guillermo Garcia-Manero, MD

Title: Low-dose oral decitabine and cedazuridine among patients with low-risk myelodysplastic syndromes
Abstract Number: 790
Session Name: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Treatment Advances in Lower risk Myelodysplastic Syndromes and Myelodysplastic/Myeloproliferative Neoplasms
Session Date: Dec. 8, 2025
Session Time: 10:30 a.m. to 12 p.m.
Presentation Time: 11:15 to 11:30 a.m.
Location: OCCC – Valencia Room W415A
Presenter: Guillermo Garcia-Manero, MD

Online Abstracts

Title: Time burden of treatment with parenteral HMAs in combination with venetoclax among patients with newly diagnosed AML
Abstract Number: 6990
Lead Author: Amer Zeidan, MD

Title: Real-World Characteristics, Treatment Modifications, and Outcomes for AML Patients Receiving HMAs + Venetoclax (1L)
Abstract Number: 8176
Lead Author: Amer Zeidan, MD

Company-Funded Externally Led Studies

Oral Presentations

Title: Phase II Study of the All-Oral Combination of Revumenib (SNDX-5613) with Decitabine/Cedazuridine (ASTX727) and Venetoclax (SAVE) in Newly Diagnosed AML
Abstract Number: 47
Session Name: 617. Acute Myeloid Leukemias: Commercially Available Therapies: Frontline treatment with intensive or lower-intensity regimens
Session Date: Dec. 6, 2025
Session Time: 9:30 to 11 a.m.
Presentation Time: 10:30 to 10:45 a.m.
Location: OCCC – Valencia Room W415A
Presenter: Wei-Ying Jen, BM BCh, FRCPath

Title: Oral decitabine/cedazuridine in combination with venetoclax in treatment-naïve high-risk myelodysplastic syndrome or chronic myelomonocytic leukemia: Updates of a Phase 1/2 clinical trial
Abstract Number: 237
Session Name: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Treatment Advances in Higher Risk Myelodysplastic Syndromes
Session Date: Dec. 6, 2025
Session Time: 2 to 3:30 p.m.
Presentation Time: 2:30 to 2:45 p.m.
Location: OCCC – Chapin Theater W415BC
Presenter: Alex Bataller, MD, PhD

Title: ASTX727 delivers superior response rates and associated survival benefit versus hydroxycarbamide/best supportive care in CMML and other MDS/MPN overlap syndromes: First results from the Phase 2 UK multicenter randomized ammo trial
Abstract Number: 488
Session Name: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Moving the Needle Through Novel Approaches in MDS and CMML
Session Date: Dec. 7, 2025
Session Time: 9:30 to 11 a.m.
Presentation Time: 10:45 to 11 a.m.
Location: OCCC – Valencia Room W415D
Presenter: Daniel H. Wiseman, MB, ChB, PhD

Title: Phase I/II Study of Decitabine/Cedazuridine (ASXT727), Venetoclax, and Gilteritinib for Patients with FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Abstract Number: 997
Session Name: 617. Acute Myeloid Leukemias: Commercially Available Therapies: Frontline treatment with intensive or lower-intensity regimens
Session Date: Dec. 8, 2025
Session Time: 4:30 to 6 p.m.
Presentation Time: 4:30 to 4:45 p.m.
Location: OCCC – Chapin Theater W320
Presenter: Roberta S. Azevedo, MD

Poster Presentations

Title: Translational Investigation of Tolinapant (ASTX660) in Acute Myeloid Leukemia Using Integrated Clinical, Bioinformatic, and Pharmacological Approaches
Abstract Number: 2552
Session Name: 802. Chemical Biology and Experimental Therapeutics: Poster I
Session Date: Dec. 6, 2025
Session Time: 5:30 to 7:30 p.m.
Location: OCCC – West Halls B3-B4

Title: A Randomized Phase II Trial of ASTX727 and Venetoclax With or Without Enasidenib for Newly Diagnosed Older Adults With IDH2 Mutant Acute Myeloid Leukemia: A MyeloMATCH Substudy (MM1OA-S03)
Abstract Number: 3466
Session Name: 617. Acute Myeloid Leukemias: Commercially Available Therapies: Poster II
Session Date: Dec. 7, 2025
Session Time: 6 to 8 p.m.
Location: OCCC – West Halls B3-B4

Title: Trial in progress: A Phase I Study Evaluating the Safety of cirtuvivint (CIRT) as Monotherapy and in Combination with ASTX727 in Patients with MDS and AML
Abstract Number: 3431
Session Name: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster II
Session Date: Dec. 7, 2025
Session Time: 6 to 8 p.m.
Location: OCCC – West Halls B3-B4

Title: Trial in Progress – A Randomized Study of ASTX727 With or Without Ladademstat in Accelerated/Blast-Phase Myeloproliferative Neoplasms
Abstract Number: 3827
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II
Session Date: Dec. 7, 2025
Session Time: 6 to 8 p.m.
Location: OCCC – West Halls B3-B4

Title: A Comparison of Overall Survival and Quality of Life in MDS Patients Treated with Azacitidine vs Decitabine: A Propensity-Matched Registry Study
Abstract Number: 3862
Session Name: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Poster II
Session Date: Dec. 7, 2025
Session Time: 6 to 8 p.m.
Location: OCCC – West Halls B3-B4

Title: A Multiarm Phase 1b Study of Personalized Oral Maintenance Therapy with Decitabine/Cedazuridine (ASTX727) Plus Physician’s Choice of Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib in Acute Myeloid Leukemia
Abstract Number: 5228
Session Name: 617. Acute Myeloid Leukemias: Commercially Available Therapies: Poster III
Session Date: Dec. 8, 2025
Session Time: 6 to 8 p.m.
Location: OCCC – West Halls B3-B4

(Press release, Taiho, NOV 13, 2025, View Source [SID1234659936])

On November 13, 2025 General Proximity, a biotechnology company discovering and developing the next generation of induced proximity medicines, reported a strategic multi-target collaboration with Daiichi Sankyo (TSE: 4568) through its Daiichi Sankyo Research Institute in Boston to apply General Proximity’s proprietary OmniTAC discovery platform to oncology programs of interest to Daiichi Sankyo.

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Induced proximity medicines enable the precise and selective modification of disease-driving proteins, creating therapeutic opportunities for traditionally undruggable targets. The approach uses small molecules to bring two proteins into close physical proximity and subsequently induce a desired therapeutic effect. The OmniTAC platform allows unbiased screening for effector proteins capable of modulating disease-relevant targets, offering a powerful and differentiated approach to drug discovery.

"Daiichi Sankyo is a leader in oncology research and development, and we are excited to work with such a strong collaborator," said Armand Cognetta, Founder & Chief Executive Officer of General Proximity. "This agreement represents an important validation of our novel induced proximity approach and highlights the potential of our OmniTAC discovery platform to deliver innovative solutions for patients."

Under the terms of the collaboration, General Proximity will leverage OmniTAC to discover and characterize novel effector-target pairs with the potential to generate first-in-class therapeutic candidates.

In parallel with this collaboration, General Proximity will continue to expand the reach of its OmniTAC platform by leveraging the precise control of proximity to address undruggable targets across multiple disease areas. In addition to oncology, the company is advancing programs in cardiometabolic disease, neurodegeneration, and longevity, underscoring its commitment to translating breakthrough science into transformative therapies for patients worldwide.

(Press release, General Proximity, NOV 13, 2025, https://www.prnewswire.com/news-releases/general-proximity-announces-multi-target-collaboration-with-daiichi-sankyo-to-discover-and-advance-novel-oncology-therapeutics-using-omnitac-platform-302612832.html [SID1234659935])

On November 13, 2025 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported the pricing of its previously announced underwritten public offering of 8,543,794 shares of its common stock at an offering price to the public of $7.25 per share, and in lieu of common stock to certain investors, pre-funded warrants to purchase up to an aggregate of 3,870,000 shares of its common stock at an offering price to the public of $7.2499 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.0001 per share exercise price for each such pre-funded warrant.

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The gross proceeds from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Verastem Oncology, are expected to be approximately $90 million. In addition, Verastem Oncology has granted the underwriters a 30-day option to purchase up to an additional 1,862,069 shares of its common stock on the same terms and conditions. The offering is expected to close on or about November 17, 2025 subject to satisfaction of customary closing conditions. All of the securities to be sold in the offering are to be sold by Verastem Oncology.

Jefferies, Guggenheim Securities and Cantor are acting as joint book-running managers for the offering. H.C. Wainwright & Co. is acting as lead manager for the offering.

Verastem Oncology intends to use the net proceeds from the public offering to fund commercial activities for AVMAPKI FAKZYNJA CO-PACK that has been approved by the U.S. Food and Drug Administration to treat KRAS-mutated recurrent Low-Grade Serous Ovarian Cancer, continued clinical research and development of product candidates including the VS-7375 oral KRAS G12D (ON/OFF) inhibitor program, and for working capital and other general corporate purposes.

A shelf registration statement on Form S-3 relating to the public offering of the securities described above was declared effective by the Securities and Exchange Commission (SEC) on November 20, 2023. The offering is being made by means of a written prospectus and prospectus supplement that form a part of the registration statement. Before you invest, you should read the preliminary prospectus supplement relating to and describing the terms of the public offering, the accompanying base prospectus, and the related registration statement and other documents that Verastem Oncology has filed with the SEC for more complete information about Verastem Oncology and the offering. An electronic copy of the preliminary prospectus supplement and accompanying prospectus relating to the offering is free and can be found by visiting EDGAR on the SEC website at www.sec.gov. An electronic copy of the final prospectus supplement and accompanying prospectus relating to the offering will be available on the SEC website at www.sec.gov or may be obtained, when available, by contacting Jefferies LLC, by mail at Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, or by telephone at (212) 518-9544, or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Equity Capital Markets, 110 E. 59th Street, 6th Floor, New York, NY 10022, or by email at [email protected].

This press release shall not constitute an offer to sell or the 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, Verastem, NOV 13, 2025, View Source [SID1234659934])