Group 1 - The article discusses the investment opportunities related to Verastem (NASDAQ: VSTM) and its RAMP 201 program data, particularly focusing on the impact of avutometinib monotherapy and its combination therapies [1] - The author emphasizes the importance of innovative companies in the biotech sector that are developing breakthrough therapies and pharmaceuticals with potential acquisition catalysts [1] Group 2 - The author has a beneficial long position in VSTM shares, indicating a personal investment interest in the company [2] - The article is presented as an independent opinion without any compensation from the company mentioned, ensuring the analysis is based on personal insights [2]

Clinical Trial Results - The combination of avutometinib and defactinib has shown a confirmed overall response rate (ORR) of 31% in evaluable patients with measurable disease in the RAMP 201 study[138]. - Among patients with KRAS mutant LGSOC, the confirmed ORR was 44%, while for KRAS wild-type patients, it was 17%[138]. - The median duration of response was 31.1 months for all evaluable patients, with 22 months for KRAS mutant and 9.2 months for KRAS wild-type populations[138]. - The median progression-free survival was 12.9 months overall, with 22 months for KRAS mutant and 12.8 months for KRAS wild-type populations[138]. - Initial results from the RAMP 203 study showed a confirmed ORR of 25% in patients treated with the combination of avutometinib and LUMAKRAS[144]. - The RAMP 205 trial, supported by a $3.8 million grant from PanCAN, reported an overall response rate (ORR) of 83% in the dose level 1 cohort[147]. - The RAMP 301 study is currently enrolling patients with recurrent LGSOC regardless of KRAS mutation status, aiming for full approval of the combination therapy[143]. - The RAMP 204 study was closed to further enrollment to prioritize the RAMP 203 study, which includes treatment-naïve patients[146]. - The company expects to report updated data from the RAMP 205 study in the first quarter of 2025[147]. Market Opportunity - The total annual incident addressable market opportunity for the combination is estimated at approximately $300 million for KRAS mutant and $374 million for KRAS wild-type populations[140]. - The total prevalent addressable market opportunity is estimated at approximately $1.7 billion for KRAS mutant and $1.6 billion for KRAS wild-type populations[140]. Financial Performance - The company reported a net loss of $24.0 million for the three months ended September 30, 2024, compared to a net loss of $20.0 million for the same period in 2023, representing a 20% increase in losses[152]. - Total operating expenses for Q3 2024 were $37.0 million, a 74% increase from $21.3 million in Q3 2023[157]. - Total revenue for the nine months ended September 30, 2024, was $10.0 million, a 100% increase compared to $0.0 million for the same period in 2023[170]. - Research and development expenses increased by 77% to $24.8 million in Q3 2024 from $13.9 million in Q3 2023, driven by higher costs in contract research organizations, consulting, and investigator fees[157]. - Research and development expense for the 2024 Period was $60.5 million, representing a 56% increase from $38.9 million in the 2023 Period[171]. - Selling, general and administrative expense for the 2024 Period was $32.8 million, a 49% increase from $22.1 million in the 2023 Period[174]. - Interest income decreased to $3.2 million in the 2024 Period from $4.3 million in the 2023 Period, a decline of 27%[176]. - Interest expense increased to $3.4 million in the 2024 Period from $3.0 million in the 2023 Period, a rise of 13%[177]. - The change in fair value of preferred stock tranche liability resulted in $4.2 million income for the 2024 Period compared to $0.3 million expense in the 2023 Period[178]. - The change in fair value of warrant liability was $13.5 million for the 2024 Period, with no warrant liability outstanding during the 2023 Period[179]. Cash Flow and Financing - As of September 30, 2024, the company had $113.2 million in cash, cash equivalents, and investments[182]. - For the nine months ended September 30, 2024, the company reported a net cash used in operating activities of $79.7 million, compared to $56.8 million for the same period in 2023[184]. - Cash provided by investing activities for the 2024 Period was $60.0 million, primarily from maturities of investments[185]. - The company raised $53.8 million in net proceeds from the issuance of common stock and warrants in July 2024[186]. - The company has borrowed $40.0 million under the Loan Agreement, with interest rates subject to fluctuations based on market conditions[191]. - The cash outflow from net losses adjusted for non-cash charges was $78.7 million for the 2024 Period, compared to $55.8 million for the 2023 Period[184]. - The cash outflow due to changes in operating assets and liabilities for the 2024 Period was primarily driven by a decrease of $2.7 million in accounts payable[184]. - The company expects to finance a portion of its business through future potential milestones and royalties from the Secura APA[181]. Collaboration and Development - The company entered into a collaboration agreement with GenFleet for exclusive rights to develop oncology programs targeting RAS pathway-driven cancers, with a lead program VS-7375/GFH375 selected in December 2023[149]. - The Phase 1 study for VS-7375/GFH375 in China began in July 2024, evaluating safety and efficacy in patients with KRAS G12D mutations[150]. - The company anticipates filing an IND for VS-7375/GFH375 in the United States by the first quarter of 2025[150]. Going Concern - The company had an accumulated deficit of $891.0 million as of September 30, 2024, raising substantial doubt about its ability to continue as a going concern[152]. - The company is exposed to market risk related to changes in interest rates, with an immediate 100 basis point change not expected to materially affect the fair market value of its investment portfolio[189]. - The company has not reported any material changes in its contractual obligations and commitments since the last annual report[188].

Core Viewpoint - Verastem, Inc. is a clinical-stage biopharmaceutical company focused on developing cancer treatments targeting the RAS/MAPK pathway, with a promising combination therapy of Avutometinib and Defactinib for recurrent low-grade serous ovarian cancer (LGSOC) expected to receive FDA approval by 2H2024 [1][12][30] Company Overview - Founded in 2010 and headquartered in Needham, Massachusetts, Verastem develops oncology treatments using small-molecule inhibitors targeting specific cancer pathways, particularly the RAS/MAPK pathway [2] - The company’s leading therapy aims to suppress uncontrolled cancerous cell proliferation associated with mutations in the RAS/MAPK pathway, which are involved in several cancer types [2] Clinical Program - The combination of Avutometinib and Defactinib is currently in a rolling NDA submission process, with expectations for completion by 2H2024 [1][4] - The clinical pipeline includes multiple trials for various indications, including recurrent LGSOC, metastatic pancreatic cancer, and mKRAS G12C non-small cell lung cancer (NSCLC) [3][6][10] Pipeline and Collaborations - The RAMP 301 trial is focused on recurrent LGSOC, while RAMP 203 and RAMP 204 are collaborations with Amgen and Mirati Therapeutics, respectively, targeting mKRAS G12C NSCLC [7][10] - The company has received Fast Track Designation from the FDA for the combination therapy of Avutometinib and Sotorasib for mKRAS G12C NSCLC [9] Market Opportunity - The total addressable market for LGSOC is substantial, with an estimated annual opportunity of $570 million and a prevalent market potential of $1.7 billion for KRAS mutant patients [12][26] - The combination therapy has shown promising early results, with an overall response rate of 45% and 60% for KRAS-mutated patients, significantly higher than current treatment options [13][26] Financial Position - As of June 30, 2024, Verastem reported cash, cash equivalents, and investments totaling $144.5 million, providing a cash runway through the anticipated FDA approval decision by 1H2025 [21][22] - The company’s market cap is approximately $98.2 million, indicating it trades below its cash value, which may present a speculative investment opportunity [20][22] Conclusion - Verastem's combination therapy of Avutometinib and Defactinib is positioned as a potentially groundbreaking treatment for recurrent LGSOC, with a viable path to regulatory approval and significant market potential [30] - The company is viewed as a speculative buy, given its promising clinical data and financial resources to support ongoing development [29][30]

Clinical Development and Market Opportunity - The combination of avutometinib and defactinib has shown a confirmed objective response rate of 27% in all patients with recurrent LGSOC, with rates of 37% in KRAS mutant and 15% in KRAS wild-type patients [112]. - The total annual incident addressable market opportunity for the combination is estimated to be approximately $300 million for KRAS mutant and $270 million for KRAS wild-type populations [114]. - The total prevalent addressable market opportunity is estimated to be approximately $1.7 billion for KRAS mutant and $1.1 billion for KRAS wild-type populations [114]. - The estimated median duration of therapy for KRAS mutant patients is 14 months, while for KRAS wild-type patients it is 7 months [117]. - The FDA granted breakthrough designation for the combination of avutometinib and defactinib for the treatment of all patients with recurrent LGSOC [110]. - The RAMP 301 study has been initiated to evaluate the combination of avutometinib and defactinib against standard chemotherapy or hormonal therapy in recurrent LGSOC patients [119]. - The RAMP 203 study has shown a confirmed overall response rate of 25% in patients with KRAS G12C NSCLC [120]. - The company plans to seek accelerated approval from the FDA for the combination of avutometinib and defactinib for patients with recurrent KRAS mutant LGSOC [113]. - The combination of avutometinib and defactinib has received orphan drug designation for the treatment of LGSOC in the United States [110]. - The company received a Therapeutic Accelerator Award from PanCAN for up to $3.8 million to support a Phase 1b/2 clinical trial of avutometinib in combination with defactinib [122]. - The RAMP 205 trial reported a confirmed overall response rate (ORR) of 83% (5/6) for patients receiving the combination of avutometinib and defactinib with gemcitabine and Nab-paclitaxel [123]. - The Phase 1 study for GFH375/VS-7375 is being conducted in approximately 20 hospitals in China, evaluating safety and efficacy in patients with advanced KRAS G12D mutant solid tumors [125]. - The collaboration with GenFleet includes options for exclusive development rights for up to three oncology programs targeting RAS pathway-driven cancers [125]. Financial Performance - Total revenue for the three months ended June 30, 2024, was $10.0 million, a 100% increase compared to $0.0 million for the same period in 2023 [132]. - Research and development expenses increased by 40% to $18.1 million for the 2024 Quarter, up from $12.9 million in the 2023 Quarter [133]. - The net loss for the three months ended June 30, 2024, was $8.3 million, a 66% improvement compared to a net loss of $24.3 million for the same period in 2023 [132]. - The company had an accumulated deficit of $867.0 million as of June 30, 2024 [127]. - The company received net proceeds of approximately $51.1 million from the sale of 13,333,334 shares of common stock in July 2024 [128]. - Total revenue for the six months ended June 30, 2024, was $10.0 million, a 100% increase compared to $0.0 million for the same period in 2023 [143]. - Research and development expenses for the 2024 Period were $35.8 million, up from $24.9 million in the 2023 Period, representing a 44% increase [144]. - Selling, general and administrative expenses increased to $20.6 million in the 2024 Period from $14.7 million in the 2023 Period, a rise of 40% [147]. - Interest income for the 2024 Period was $2.4 million, compared to $2.1 million in the 2023 Period, marking a 12% increase [148]. - Interest expense rose to $2.3 million in the 2024 Period from $1.9 million in the 2023 Period, reflecting a 20% increase [149]. - The change in fair value of preferred stock tranche liability resulted in an income of $4.2 million for the 2024 Period, compared to an expense of $0.5 million in the 2023 Period [150]. - Cash outflow from operating activities was $55.9 million for the 2024 Period, compared to $40.2 million for the 2023 Period [154]. - As of June 30, 2024, the company had $83.4 million in cash, cash equivalents, and investments [152]. - The company received a $10.0 million milestone payment in July 2024 due to Secura achieving cumulative worldwide net sales of COPIKTRA exceeding $100.0 million [143]. - The fair value of the preferred stock tranche liability decreased from $4.2 million at the beginning of the 2024 Period to $0.0 million at the end of the 2024 Period [150]. - Net cash used in operating activities for six months ended June 30, 2024, was $(55,877) thousand, compared to $(40,190) thousand for the same period in 2023, indicating a decline in operational cash flow [157]. - Cash, cash equivalents, and investments totaled $83.4 million as of June 30, 2024, primarily consisting of interest-bearing assets [159]. - The company has borrowed $40.0 million under a Loan Agreement, with interest rates subject to fluctuations based on the one-month CME Secured Overnight Financing Rate plus a margin [161]. - The increase in cash, cash equivalents, and restricted cash for the six months ended June 30, 2024, was $4,536 thousand, a significant decrease from $108,537 thousand in the prior year [157]. - Financing activities resulted in cash inflow of $441 thousand for the six months ended June 30, 2024, a significant decrease from $135,531 thousand in the prior year, indicating reduced financing activities [157]. Risk Factors - The company anticipates continued operating losses due to ongoing research and development costs and lack of regulatory approval for product candidates [129]. - The company is exposed to interest rate risk, but a 100 basis point change in interest rates would not materially affect the fair market value of its investment portfolio due to its short-term duration [159]. - As of June 30, 2024, an immaterial amount of total liabilities were denominated in foreign currencies, indicating limited exposure to foreign currency fluctuations [160]. - The company’s available-for-sale securities are subject to interest rate risk, which could lead to a decline in value if market interest rates increase [159]. - A 10% increase in current interest rates would result in an immaterial increase in cash interest expense due to the overall interest rate floor and cap in the Loan Agreement [161].

Verastem Oncology (VSTM) announced that it has dosed the first patient in a phase I/II study evaluating its KRAS G12D inhibitor, GFH375/VS-7375, for treating KRAS G12D mutant solid tumors. Verastem's collaboration partner GenFleet Therapeutics is conducting the study in China. We note that after evaluating the initial dose escalation data from the above mentioned phase I study in China, VSTM plans to expedite the development path ahead for GFH375/VS-7375 in the United States. In May 2024, VSTM initiated the ...

LOS ANGELES, July 10, 2024 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Verastem, Inc. ("Verastem" or the "Company") (NASDAQ: VSTM) investors that the firm has initiated an investigation into possible securities fraud and may file a class action on behalf of investors. Verastem investors that lost money on their investment are encouraged to contact Lesley Portnoy, Esq. Please visit our website to review more information and submit your transaction information. Investors can contact the law firm at no co ...

Group 1 - Pomerantz LLP is investigating claims on behalf of investors of Verastem, Inc. regarding potential securities fraud or unlawful business practices by the company and its officers or directors [1] - Following the news of the investigation, Verastem's stock price dropped by $8.06 per share, representing a decline of 66.17%, closing at $4.12 per share on May 24, 2024 [3] - On May 23, 2024, Verastem announced interim safety and efficacy results from the RAMP 205 Phase 1/2 clinical trial, revealing that 12 patients experienced 19 treatment-emergent serious adverse events [5] Group 2 - Pomerantz LLP is recognized as a leading firm in corporate, securities, and antitrust class litigation, with a history of recovering multimillion-dollar damages for victims of securities fraud and corporate misconduct [4]

On this news, Verastem's stock price fell $8.06 per share, or 66.17%, to close at $4.12 per share on May 24, 2024. Attorney advertising. Prior results do not guarantee similar outcomes. [Click here for information about joining the class action] Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean ...

NEW YORK, June 30, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Verastem, Inc. ("Verastem" or the "Company") (NASDAQ: VSTM). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. On May 23, 2024, Verastem issued a press release "announc[ing] the initial interim safety and efficacy results from the ongoing RAMP 205 Phase 1/2 clinical trial evaluating avutometinib plus defactinib in combination with gemcitabine and ...

For the transition period from to Commission file number: 001-35403 Table of Contents Verastem, Inc. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 For the quarterly period ended March 31, 2024 FORM 10-Q OR (Mark One) ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 02494 (Zip Code) (781) 292-4200 (Registrant's telephone number, including area code) Sec ...