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])

On November 13, 2025 Aptose Biosciences Inc. ("Aptose" or the "Company") (TSX: APS and OTC: APTOF), a clinical-stage precision oncology company developing a tuspetinib (TUS)-based triple drug frontline therapy to treat patients with newly diagnosed acute myeloid leukemia (AML), reported financial results for the third quarter ended September 30, 2025, and provided a corporate update.

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"Tuspetinib in combination with VEN+AZA standard treatment (TUS+VEN+AZA) has been highly active and so well tolerated in newly diagnosed AML patients with 40 mg, 80 mg, and 120 mg TUS, we dose escalated to the 160 mg TUS dose level in the triplet," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. "Patients evaluated at the higher dose levels of 80 mg and 120 mg TUS have all (6/6; 100%) achieved CR/CRh responses, exceeding the 66% rate expected from VEN+AZA alone. We now are dosing at 160 mg TUS, and we look forward to providing further updates next month at ASH (Free ASH Whitepaper)."

Key Corporate Highlights

Tuspetinib Data Reported at European School of Haematology (ESH) 7th International Conference Data from the ongoing TUSCANY trial of tuspetinib in combination with venetoclax and azacitidine (TUS+VEN+AZA) were presented in a poster presentation, "TUSCANY Study of Safety and Efficacy of Tuspetinib plus Standard of Care Venetoclax and Azacitidine in Study Participants with Newly Diagnosed AML Ineligible for Induction Chemotherapy," at the European School of Haematology (ESH) 7th International Conference on Acute Myeloid Leukemia "Molecular and Translational": Advances in Biology and Treatment, held in October in Estoril, Portugal. Data from 10 patients in the TUSCANY trial across all three cohorts, 40 mg, 80 mg or 120 mg TUS dose in TUS+VEN+AZA, reveal promising clinical safety and antileukemic activity and support the use of TUS with standard of care treatment across a broad range of AML populations, including those carrying adverse mutations regardless of FLT3 mutation status.

As reported, the addition of TUS to VEN+AZA achieved CR/CRh responses in 6/6 (100%) patients treated at the higher dose levels of 80 mg and 120 mg TUS, exceeding the 66% rate expected from VEN+AZA alone. Overall, TUS+VEN+AZA has delivered CR/CRh responses in 9/10 (90%) patients. CR/CRh responses were achieved across diverse mutational subtypes including unmutated FLT3, FLT3-ITD, NPM1c, biallelic TP53 with complex karyotype, RAS, and myelodysplasia related mutations. MRD-negativity with TUS+VEN+AZA was observed in 7/9 (78%) of responding patients by central flow cytometry, and hematopoietic stem cell transplants (HSCT) have been completed in 2 patients to date.

Aptose Clinical Data Accepted for Poster Presentation at ASH (Free ASH Whitepaper) – Aptose was notified that its abstract, "TUSCANY Study demonstrates safety and efficacy of tuspetinib plus standard of care venetoclax and azacitidine in patients with newly diagnosed AML ineligible for induction chemotherapy," has been selected for poster presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. The meeting is scheduled to take place December 6-9, 2025, in Orlando, Florida. The abstract accepted for presentation can be viewed online at the ASH (Free ASH Whitepaper) conference website here, and will appear in the November supplemental issue of Blood. The actual presentation will include more recent updates and additional data not found in the abstract.
Completed and Planned Value-Creating Milestones

2025: 1H

Reported safety and efficacy with 40mg TUS+VEN+AZA
Reported safety and efficacy with 80mg TUS+VEN+AZA
2025: European Hematology Association (EHA) (Free EHA Whitepaper)

Reported maturing data from TUS+VEN+AZA triplet study
2025: 2H

Reported safety and efficacy with 120 mg TUS+VEN+AZA
CSRC review of data; decision to dose escalate to 160 mg TUS+VEN+AZA
2025: European School of Haematology (ESH) 7th International Conference

Reported excellent safety across three TUS dose levels of TUS+VEN+AZA
Reported CR/CRh responses in patients with biallelic TP53 mutations
Reported evolving data from 120 mg TUS+VEN+AZA triplet
2025: American Society of Hematology (ASH) (Free ASH Whitepaper)

Report evolving response rate and durability data from four (4) dose levels of TUS+VEN+AZA triplet
Report safety and tolerability of TUS with VEN+AZA in combination with unadjusted dosing of VEN+AZA
FINANCIAL RESULTS OF OPERATIONS
Aptose Biosciences Inc.
Statements of Operations Data
(unaudited)
($ in thousands, except for share and per share data)

Three months ended
September 30,
Nine months ended
September 30,
2025
2024
2025
2024
Operating expenses:
Research and development $ 2,205 $ 4,702 $ 7,867 $ 15,560
General and administrative 2,708 2,263 9,428 8,510
Total operating expenses 4,913 6,965 17,295 24,070
Other (expense) income, net (210 ) 12 (414 ) 225
Net loss $ (5,123 ) $ (6,953 ) $ (17,709 ) $ (23,845 )
Net loss per share, basic and diluted $ (2.01 ) $ (11.33 ) $ (7.34 ) $ (44.41 )
Weighted average number of common shares outstanding used in the calculation of basic and diluted loss per common share
2,552,429 613,604 2,411,943 536,891

Net loss for the quarter ended September 30, 2025 decreased by $1.8 million to $5.1 million, as compared to $7.0 million for the comparable period in 2024. Net loss for the nine months ended September 30, 2025 decreased by $6.1 million to $17.7 million, as compared to $23.8 million for the comparable period in 2024.

Aptose Biosciences Inc.
Balance Sheet Data
(unaudited)
($ in thousands)

September 30, December 31,
2025
2024
Cash, cash equivalents and restricted cash equivalents $ 1,637 $ 6,707
Working capital (3,302 ) 5,053
Total assets 6,341 10,127
Long-term liabilities 18,712 10,193
Accumulated deficit (558,676 ) (540,967 )
Shareholders’ deficit (19,450 ) (4,543 )

Total cash, cash equivalents and restricted cash equivalents as of September 30, 2025 were $1.6 million. The Company does not have sufficient cash to fund operations and relies on advances made by Hanmi to fund operations. The Company is actively deploying financing and cost reduction efforts to extend cash runway.
As of November 7, 2025, there were 2,552,429 common shares of the Company ("Common Shares") issued and outstanding. In addition, there were 37,370 Common Shares issuable upon the exercise of outstanding stock options and there were 1,267,585 Common Shares issuable upon the exercise of the outstanding warrants.
RESEARCH AND DEVELOPMENT EXPENSES

Research and development expenses for the three and nine months ended September 30, 2025 and 2024 were as follows:

Three months ended
Nine months ended
September 30,
September 30,
(in thousands) 2025
2024
2025
2024

Program costs – Tuspetinib $ 1,423 $ 4,067 $ 5,135 $ 10,656
Program costs – Luxeptinib 91 (225 ) 290 287
Program costs – APTO-253 - - - 13
Personnel related expenses 661 941 2,258 4,274
Stock-based compensation 30 (81 ) 184 317
Depreciation of equipment - - - 13
Total $ 2,205 $ 4,702 $ 7,867 $ 15,560

Research and development expenses decreased by $2.5 million to $2.2 million for the quarter ended September 30, 2025, as compared to $4.7 million for the comparable period in 2024. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:

Program costs for tuspetinib were $1.4 million for the quarter ended September 30, 2025, compared with $4.1 million for the comparable period in 2024. The lower program costs for tuspetinib in the current period are attributable to reduced activity in our APTIVATE clinical trial, reduced manufacturing activity, and related expenses.
Program costs for luxeptinib increased by approximately $0.3 million during the three months ended September 30, 2025 compared to the comparable period in 2024 due to a refund provided by one of our clinical vendors during the three months ended September 30, 2024.
The Company discontinued further development of APTO-253.
Personnel-related expenses decreased by $0.3 million due to lower headcount for research and development personnel in the current quarter.
Stock-based compensation increased by $0.1 million in the quarter ended September 30, 2025, compared to the comparable period in 2024, primarily due to forfeitures recognized during the three months ended September 30, 2024 in connection with employee terminations during the period.
Research and development expenses decreased by $7.7 million to $7.9 million for the nine months ended September 30, 2025, as compared to $15.6 million for the comparable period in 2024. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:

Program costs for tuspetinib were $5.1 million for the nine months ending September 30, 2025, compared to $10.7 million for the comparable period in 2024. The increased costs associated with the TUSCANY study were offset by a decrease in tuspetinib development expenses during the current period. This reduction is due to the conclusion of activities in our APTIVATE clinical trial during the current period, compared to higher APTIVATE activities during the nine months ended September 30, 2024, as well as lower manufacturing and related development costs.
Program costs for luxeptinib remained consistent during the nine months ended September 30, 2025 compared to the comparable period in 2024.
The Company discontinued further development of APTO-253.
Personnel-related expenses decreased by $2.0 million due to lower headcount for research and development personnel in the current quarter.
Stock-based compensation decreased by approximately $0.1 million in the nine months ended September 30, 2025, compared to the comparable period in 2024, primarily due to stock options forfeited and/or vested in prior periods that are no longer being expensed resulting in lower expense in the current period.

(Press release, Aptose Biosciences, NOV 13, 2025, View Source [SID1234659890])

On November 13, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that Jannie Oosthuizen, president, Human Health U.S., and Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, are scheduled to participate in a fireside chat at the Jefferies Global Healthcare Conference in London on Thursday, Nov. 20, 2025, at 9:30 a.m. ET / 2:30 p.m. GMT.

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink.

(Press release, Merck & Co, NOV 13, 2025, View Source [SID1234659906])

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 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported that the U.S. Food and Drug Administration (FDA) completed its filing review and accepted the company’s New Drug Application (NDA) for n.c.a. 177Lu-edotreotide (also known as ITM-11 or 177Lu-edotreotide). 177Lu-edotreotide is ITM’s proprietary, synthetic, targeted radiotherapeutic investigational agent for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2026.

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"The FDA’s acceptance of our NDA is an important regulatory milestone in advancing this new radiopharmaceutical treatment option for patients with GEP-NETs," said Dr. Celine Wilke, chief medical officer of ITM. "In the Phase 3 COMPETE trial, 177Lu-edotreotide demonstrated extended PFS, a straightforward dosing regimen, and a favorable safety profile, supporting its potential to improve the current treatment paradigm. We look forward to working closely with the FDA toward potential approval."

The NDA submission for 177Lu-edotreotide is supported by results from the Phase 3 COMPETE study, a prospective, randomized, controlled, open-label trial that enrolled 309 patients with inoperable, progressive Grade 1 or Grade 2 GEP-NETs as a first- or second-line treatment. The trial met its primary endpoint, revealing a significantly longer median mPFS in patients treated with agent177Lu-edotreotide compared to everolimus, a targeted molecular therapy. Patients treated with 177Lu-edotreotide also demonstrated a significantly higher ORR compared to everolimus.

"This milestone reflects more than 20 years of leadership and dedication to advancing the radiopharmaceutical field, built on our global isotope manufacturing, clinical expertise, and pipeline of targeted therapeutics and diagnostics," said Dr. Andrew Cavey, chief executive officer of ITM. "Above all, we are driven by a single focus: making a real difference for people living with hard-to-treat cancers."

About the COMPETE Trial

The COMPETE trial (NCT03049189) evaluated177Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with177Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus.177Lu-edotreotide is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, SSTR-positive GEP-NET tumors.

(Press release, ITM Isotopen Technologien Munchen, NOV 13, 2025, View Source [SID1234661164])