VSTM — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-07

• We are a biopharmaceutical company committed to developing and commercializing new medicines to improve the lives of patients diagnosed with challenging RAS/MAPK pathway-driven cancers. We market AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets) in the United States (“U.S.”), the …

• Our pipeline includes clinical-stage programs, preclinical research programs and externally partnered early-stage programs. Our focus is on novel small molecule drugs developed both as monotherapy and in combination, which inhibit critical signaling pathways in cancer that promote cancer cell surviv…

• AVMAPKI FAKZYNJA CO-PACK is the first treatment specifically approved by the FDA for adults with KRAS-mutated recurrent LGSOC who have received prior systemic therapy. AVMAPKI (avutometinib) inhibits MEK kinase activity while also blocking the compensatory reactivation of MEK by upstream RAF. RAF an…

• The combination is being evaluated in an ongoing international Phase 3 trial, RAMP 301, in recurrent LGSOC with or without a KRAS mutation. The trial was fully enrolled, as of December 2025, and will serve as a confirmatory study for the initial indication and has the potential to expand the indicat…

• ØIn April 2026, we announced new two-year median follow up data from the Phase 2 RAMP 201 trial that demonstrated durable benefit of avutometinib plus defactinib across both KRAS-mutant and KRAS wild-type recurrent LGSOC patients, with discontinuation rates consistent with the primary analysis, pres…

Text removed vs the prior filing · source: 10-Q · 2025-11-04

• We are a biopharmaceutical company committed to the development and commercialization of new medicines to improve the lives of patients diagnosed with RAS MAPK pathway-driven cancers. We market AVMAPKI™ FAKZYNJA™ CO-PACK (avutometinib capsules; defactinib tablets) in the United States. Our pipeline …

• On May 8, 2025, the FDA approved AVMAPKI FAKZYNJA CO-PACK for the treatment of adult patients with “KRAS mt” recurrent LGSOC who received prior systemic therapy. The KRAS mutant recurrent LGSOC indication has been granted approval by the FDA under the accelerated approval pathway based on the tumor …

• AVMAPKI (avutometinib) inhibits MEK kinase activity while also blocking the compensatory reactivation of MEK by upstream RAF. RAF and MEK proteins are regulators of the RAS/RAF/MEK/ extracellular-signal-regulated-kinase (“ERK”) MAPK pathway. Blocking RAF and/or MEK activates FAK, a key mediator of d…

• In the fourth quarter of 2020, we commenced a registration-directed trial investigating avutometinib in combination with defactinib for the treatment of patients with recurrent LGSOC entitled RAMP 201 study. We use the term “RAMP” to refer to our RAF and MEK Program. The RAMP 201 study is an adaptiv…

• In December 2023, we announced the initiation of a confirmatory Phase 3 trial to evaluate the combination of avutometinib and defactinib for the treatment of patients with recurrent LGSOC entitled RAMP 301. RAMP 301 is a randomized global confirmatory trial, which is evaluating the efficacy and safe…

Text added vs the prior filing · source: 10-Q · 2026-05-07

• ØWe will require additional financing to execute our operating plan and continue to operate as a going concern.

• As required under Accounting Standards Update 2014-15, Presentation of Financial Statements-Going Concern (ASC 205-40), we have the responsibility to evaluate whether conditions and/or events raise substantial doubt about our ability to meet our future financial obligations as they become due within…

Text removed vs the prior filing · source: 10-Q · 2025-11-04

• Recent health care reform initiatives focused on the cost of prescription drugs may have a material adverse effect on our business and results of operations.

• Under the current United States presidential administration, there have been significant and wide-ranging reforms to federal policy and the federal government. Drug pricing and reimbursement reform have been a particular area of focus. For example, President Trump issued an Executive Order in April …

• Orders, some pharmaceutical manufacturers have announced direct-to-consumer offerings with discounted prices or reached agreement with the federal government regarding pricing for drugs, including prices for Medicaid drugs and newly launched products, federal agencies are reportedly developing new d…

• The implementation and impact of these or other prescription drug reform initiatives is uncertain. As a result, there can be no assurance that such reform will not have a significant adverse impact on our business.

• Due to the January 2025 change in presidential administration, we face substantial uncertainty regarding potential regulatory developments in the United States that may adversely affect our business.