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SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Verastem, Inc. – VSTM
GlobeNewswire News Room· 2024-06-30 15:36
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 ...
Verastem(VSTM) - 2024 Q1 - Quarterly Report
2024-05-09 20:08
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 ...
Verastem(VSTM) - 2023 Q4 - Annual Report
2024-03-14 20:55
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-35403 Verastem, Inc. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction o ...
Verastem(VSTM) - 2023 Q3 - Quarterly Report
2023-11-08 21:16
Financial Performance - The company has an accumulated deficit of $797.5 million as of September 30, 2023[151]. - The net loss for the three months ended September 30, 2023, was $20.0 million, compared to $60.0 million for the same period in 2022[151]. - Total revenue for the nine months ended September 30, 2023 was $0.0 million, a decrease of 100% from $2.6 million in the same period of 2022[168]. - Net loss for Q3 2023 was $20.0 million, an increase of 11% compared to a net loss of $18.1 million in Q3 2022[157]. - Research and development expenses for Q3 2023 were $13.9 million, an increase of 24% from $11.3 million in Q3 2022[157]. - Total operating expenses for Q3 2023 were $21.3 million, up 20% from $17.7 million in Q3 2022[157]. - Research and development expenses for the nine months ended September 30, 2023 were $38.9 million, a slight decrease of 2% from $39.8 million in the same period of 2022[169]. - Selling, general and administrative expenses for the nine months ended September 30, 2023 were $22.1 million, an increase of 17% from $18.9 million in the same period of 2022[168]. - Selling, general and administrative expenses increased to $22.1 million in 2023 from $18.9 million in 2022, a rise of 16.9%[174]. - Interest income for Q3 2023 was $2.2 million, a significant increase of 611% from $0.3 million in Q3 2022[165]. - Interest expense for Q3 2023 was $1.1 million, up 57% from $0.7 million in Q3 2022[166]. - Interest income surged to $4.3 million in 2023, up from $0.4 million in 2022, reflecting a significant increase of 975% driven by higher interest rates and investment balances[176]. - Interest expense rose to $3.0 million in 2023 compared to $1.4 million in 2022, marking an increase of 114.3% primarily due to a loan agreement with Oxford[177]. - Net cash used in operating activities was $56.8 million for the 2023 period, compared to $47.1 million in 2022, indicating a 20.4% increase in cash outflow[182]. - Cash provided by financing activities in 2023 was $134.6 million, significantly higher than $51.8 million in 2022, reflecting a 159.5% increase[184]. - The company expects existing cash resources to fund planned operations for at least 12 months from the date of the financial statements[151]. - The company is exposed to interest rate risk, with a total of $165.7 million in cash and investments as of September 30, 2023, which could be affected by changes in U.S. interest rates[191]. - As of September 30, 2023, the company had $165.7 million in cash, cash equivalents, and investments[181]. Clinical Trials and Research - The combination of avutometinib and defactinib demonstrated an overall objective response rate (ORR) of 45% in patients with recurrent low-grade serous ovarian cancer (LGSOC) in the RAMP 201 trial[142]. - Among patients with KRAS mutant LGSOC, the ORR was 60%, while it was 29% for KRAS wild-type LGSOC[143]. - The FRAME study showed an ORR of 42% in evaluable patients with LGSOC, with a median duration of response of 26.9 months[144]. - The company plans to initiate a confirmatory Phase 3 trial (RAMP 301) to evaluate the efficacy and safety of the combination therapy in recurrent LGSOC in the second half of 2023[145]. - The RAMP 203 trial, evaluating the combination of avutometinib with Amgen's KRAS G12C inhibitor, has shown a confirmed ORR of 25% across efficacy-evaluable patients[146]. - The company received a grant of up to $3.8 million from the Pancreatic Cancer Network to support the RAMP 205 trial, which will evaluate the combination of avutometinib and defactinib in pancreatic cancer[148]. Strategic Partnerships - The company entered into a collaboration agreement with GenFleet Therapeutics, involving an upfront payment of $2.0 million and potential milestone payments of up to $622.0 million[186][187]. - The company expects to finance operations through future potential milestones and royalties from the Secura APA[180]. - The company may terminate the GenFleet Agreement with 90 days written notice, allowing flexibility in its strategic partnerships[188]. - The company made a $2.0 million upfront payment in September 2023 under the GenFleet Agreement, contributing to increased R&D costs[162].
Verastem(VSTM) - 2023 Q2 - Quarterly Report
2023-08-08 20:16
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) (Exact name of registrant as specified in its charter) Delaware OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-35403 For the quarterly period ended June 30, 2023 Verastem, Inc. (State or other jurisdict ...
Verastem(VSTM) - 2023 Q1 - Quarterly Report
2023-05-09 20:18
Financial Performance - The company reported a net loss of $15.7 million for the three months ended March 31, 2023, compared to a net loss of $17.0 million for the same period in 2022, indicating a reduction in losses year-over-year [140]. - Total revenue for the three months ended March 31, 2023, was $0.0 million, a decrease of 100% compared to $2.6 million for the same period in 2022 [148]. - Research and development expenses decreased by $1.6 million, or 12%, from $13.6 million in the 2022 Period to $12.0 million in the 2023 Period [149]. - Selling, general and administrative expenses increased by $1.4 million, or 24%, from $5.9 million in the 2022 Period to $7.3 million in the 2023 Period [155]. - Interest income for the 2023 Period was $1.0 million, an increase of 2022% compared to less than $0.1 million in the 2022 Period [157]. - Interest expense rose to $0.8 million in the 2023 Period, a significant increase of 1273% from $0.1 million in the 2022 Period [160]. - The change in fair value of preferred stock tranche liability was $3.4 million for the 2023 Period, with no liability reported in the 2022 Period [161]. - Net cash used in operating activities was $20.3 million for the 2023 Period, compared to $19.3 million for the 2022 Period [164]. - Cash provided by financing activities for the 2023 Period was $44.1 million, compared to $25.5 million for the 2022 Period [166]. Cash and Investments - As of March 31, 2023, the company had an accumulated deficit of $753.2 million and cash, cash equivalents, and investments totaling $111.2 million, expected to fund operations for at least the next 12 months [140]. - Cash, cash equivalents, and investments totaled $111.2 million as of March 31, 2023 [163]. - The company expects to finance cash needs through equity offerings, debt financings, collaborations, and licensing arrangements, which may dilute existing stockholders' ownership [199]. - The company has ongoing and potential future clinical trials that will impact commercialization activities and regulatory review outcomes [202]. Clinical Trials and Research - The company is advancing two registration-directed trials, RAMP 201 and RAMP 202, to evaluate the efficacy and safety of avutometinib alone and in combination with defactinib in patients with recurrent low-grade serous ovarian cancer (LGSOC) and KRAS G12V non-small cell lung cancer (NSCLC) [131]. - The combination of avutometinib and defactinib has received breakthrough designation from the FDA for the treatment of all patients with recurrent LGSOC, regardless of KRAS status [130]. - The company received a Therapeutic Accelerator Award from the Pancreatic Cancer Network for up to $3.8 million to support a Phase 1b/2 clinical trial of avutometinib in combination with defactinib for pancreatic cancer [138]. - The RAMP 203 trial, evaluating the combination of avutometinib with Amgen's KRAS G12C inhibitor LUMAKRAS, has advanced to Phase 2 dose expansion [135]. - The RAMP 204 trial, assessing the combination of avutometinib with Mirati's KRAS G12C inhibitor KRAZATI, is currently open and enrolling patients [136]. - The company plans to include mature data from the RAMP 201 study to potentially support filing for accelerated approval in patients with recurrent LGSOC [133]. - Continued enrollment in the combination arm of RAMP 201 is planned to expand clinical experience in anticipation of a confirmatory study [133]. - The company anticipates continued significant expenses and operating losses as it advances clinical trials and expands its intellectual property portfolio [196]. Financing Activities - The first tranche of the Private Placement closed on January 27, 2023, generating gross proceeds of $30.0 million [169]. - The company plans to sell and issue 944,160 shares of Series B Convertible Preferred Stock at a price of $31.77 per share, potentially raising approximately $30.0 million if certain conditions are met [170]. - The Series B Convertible Preferred Stock ranks senior to common stock and junior to all existing and future debt obligations [171]. - The company has entered into a loan agreement for up to $150.0 million, with an initial term loan of $25.0 million funded at closing and an additional $15.0 million funded upon achieving specific milestones [176]. - The term loans bear interest at a floating rate, with a minimum of 7.37%, and are due in full by March 1, 2027 [177]. - The company has a finance agreement with AFCO for $1.4 million at an interest rate of 7.4% per annum, requiring monthly payments of $0.1 million through October 2023 [182]. - The company borrowed a total of $40.0 million under a Loan Agreement, with interest rates subject to fluctuations based on the one-month CME Secured Overnight Financing Rate plus 7.37% [205]. Licensing and Revenue - The company sold its exclusive worldwide license for duvelisib to Secura for an upfront payment of $70.0 million, with potential milestone payments totaling up to $95.0 million [193]. - During the 2022 period, the company recognized $2.6 million in revenue from the sale of the COPIKTRA license and related assets [195]. - The company anticipates receiving milestone payments and royalties under the Secura APA, which will depend on the timing of such receipts [202]. - The company may need to relinquish valuable rights to technologies or revenue streams if additional funds are raised through collaborations or licensing arrangements [199]. Market Risks - The company is exposed to market risk related to interest rate changes, with a potential immaterial effect on the fair market value of its investment portfolio from a 100 basis point change in interest rates [201]. - A 10% increase in current interest rates would have resulted in an immaterial increase in cash interest expense for the three months ended March 31, 2023, due to the interest rate floor and cap [205]. - As of March 31, 2023, an immaterial amount of total liabilities were denominated in foreign currencies, indicating limited exposure to foreign currency fluctuations [204]. Contractual Obligations - The company has not reported any material changes in its contractual obligations and commitments since the last Annual Report [200].
Verastem(VSTM) - 2022 Q4 - Annual Report
2023-03-14 21:00
Financial Performance - As of December 31, 2022, the company had an accumulated deficit of $737.5 million and a net loss of $73.8 million for the year ended December 31, 2022[415]. - Total revenue for the year ended December 31, 2022, was $2.596 million, a decrease from $88.516 million in 2020[463]. - Product revenue, net was $0 for the years ended December 31, 2022 and 2021, compared to $15.232 million in 2020[463]. - The net loss for the year ended December 31, 2022, was $73.812 million, compared to a net loss of $71.200 million in 2021[463]. - The company had no product revenue recorded for the years ended December 31, 2022 and 2021, indicating a shift in revenue strategy[441]. - The company may incur losses for the foreseeable future and may never achieve or maintain profitability[496]. Research and Development - Research and development expenses for the year ended December 31, 2022, totaled $50.6 million, an increase from $39.3 million in 2021[429]. - Total research and development expenses included $22.4 million for the combination of avutometinib and defactinib in 2022, up from $17.0 million in 2021[429]. - Research and development expenses increased to $50.558 million in 2022 from $39.347 million in 2021[463]. - The company expects to incur significant expenses and may continue to experience operating losses due to ongoing research and development of its lead product candidates, avutometinib and defactinib[415]. - Avutometinib and defactinib are being investigated for various solid tumors, including low-grade serous ovarian cancer and non-small cell lung cancer[412]. - Research and development expenses increased to $50.6 million in 2022 from $39.3 million in 2021, with significant increases in drug substance costs and CRO costs[467]. Cash and Investments - Cash, cash equivalents, and investments as of December 31, 2022, were $87.9 million, with additional expected funding from a $30.0 million Series B Preferred Stock issuance and a $15.0 million debt drawdown[415]. - As of December 31, 2022, the company had $87.9 million in cash, cash equivalents, and investments[472]. - The company had cash, cash equivalents, and investments totaling $87.9 million as of December 31, 2022, down from $100.3 million in 2021[509]. - Net cash used in operating activities was $63.7 million in 2022, compared to $53.5 million in 2021, reflecting net losses adjusted for non-cash charges[475]. - Cash provided by investing activities in 2022 was $66.2 million, primarily from net maturities of investments[476]. - Financing activities generated $51.8 million in 2022, including $27.4 million from an at-the-market equity offering program[477]. Expenses - Selling, general and administrative expenses were $24.975 million in 2022, slightly up from $24.115 million in 2021[463]. - Selling, general and administrative expenses rose to $25.0 million in 2022, compared to $24.1 million in 2021, driven by higher commercial operations costs[468]. - Interest expense decreased significantly to $2.137 million in 2022 from $9.972 million in 2021[463]. - Interest expense decreased to $2.1 million in 2022 from $10.0 million in 2021, largely due to the conversion of 2020 Notes into common stock in July 2021[470]. - Interest income increased to $1.215 million in 2022 from $181,000 in 2021[463]. - Interest income for 2022 was $1.2 million, a significant increase from $0.2 million in 2021, primarily due to rising interest rates on debt securities[469]. Strategic Decisions - The company sold its exclusive worldwide license for duvelisib to Secura Bio, Inc., allowing it to focus on its lead product candidates[413]. - The company anticipates financing future development costs through existing cash, milestone payments, and potential strategic financing opportunities[418]. - The company expects to finance its cash needs through a combination of equity offerings, debt financings, and collaborations[500]. - The company entered into a loan agreement with Oxford for up to $150.0 million, with an initial term loan of $25.0 million funded at closing[478]. - The company has borrowed $25.0 million under a Loan Agreement, which bears interest at a floating rate subject to an overall floor and cap[511]. Impact of COVID-19 - The COVID-19 pandemic has impacted clinical trial operations, causing delays in startup activities and limiting new clinical trials[419]. - The company has adopted a hybrid work program for employees in response to the COVID-19 pandemic[419]. Assets and Liabilities - As of December 31, 2022, the company had a right-of-use asset of $1.8 million and lease liability of $2.3 million[461]. - As of December 31, 2022, the company had federal net operating loss carryforwards of $436.6 million and state net operating loss carryforwards of $203.3 million, available to reduce future taxable income[503]. - As of December 31, 2022, there was $0.3 million aggregate principal amount outstanding of 2018 Notes[495].
Verastem(VSTM) - 2022 Q3 - Quarterly Report
2022-11-03 20:34
Table of Contents For the transition period from to Commission file number: 001-35403 Verastem, Inc. (Exact name of registrant as specified in its charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Delaware (State or other juri ...
Verastem (VSTM) Investor Presentation - Slideshow
2022-08-14 17:56
RASTEM® Corporate Presentation August 2022 Safe Harbor Statement This presentation includes forward-looking statements about, among other things, Verastem Oncology's programs and product candidates, including anticipated regulatory submissions, approvals, performance and potential benefits of Verastem Oncology's product candidates, that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Applicable risks ...
Verastem(VSTM) - 2022 Q2 - Quarterly Report
2022-08-08 20:24
Financial Performance - The company reported a net loss of $22.0 million for the three months ended June 30, 2022, compared to a net loss of $38.9 million for the same period in 2021[117]. - Net loss for the three months ended June 30, 2022, was $21.9 million, representing a 30% increase from a net loss of $16.9 million in the same period of 2021[126]. - Total revenue for the three months ended June 30, 2022, was $0.5 million, a decrease of 100% compared to $500,000 in the same period of 2021[126]. - Total revenue for the six months ended June 30, 2022, was $2.6 million, a 72% increase from $1.5 million in the same period of 2021[139]. - Transition services revenue was $0.0 million in the 2022 Quarter, a decrease of 100% from $0.4 million in the 2021 Quarter, as services were substantially completed in 2021[127]. - The company recorded other income of $34,000 in the 2022 Period, compared to no other income in the 2021 Period[146]. Cash and Investments - As of June 30, 2022, the company had an accumulated deficit of $702.6 million and cash, cash equivalents, and investments totaling $94.3 million[117]. - The company has cash, cash equivalents, and investments totaling $94.3 million as of June 30, 2022, with primary exposure to interest rate sensitivity due to the nature of its investment portfolio[191]. - For the six months ended June 30, 2022, the company reported a net cash used in operating activities of $31.975 million, compared to $32.742 million for the same period in 2021[153]. - Cash provided by investing activities for the 2022 Period was $48.5 million, primarily from net maturities of investments[154]. - The cash inflow from operating activities due to changes in operating assets and liabilities was $3.4 million for the 2022 Period[153]. Research and Development - The ongoing FRAME study is evaluating the combination of VS-6766 and defactinib in patients with recurrent low-grade serous ovarian cancer (LGSOC) and KRAS mutant tumors[108]. - The combination of VS-6766 and defactinib has received breakthrough designation from the FDA for the treatment of all patients with recurrent LGSOC[105]. - The company expects to report topline results from Part A of the RAMP 202 study in the second half of 2022[109]. - The company received a "Therapeutic Accelerator Award" of up to $3.8 million from the Pancreatic Cancer Network to support a Phase 1b/2 clinical trial of VS-6766 in combination with defactinib[113]. - The company has initiated registration-directed trials entitled RAMP 201 and RAMP 202 to evaluate the efficacy and safety of VS-6766 alone and in combination with defactinib[109]. - Approximately 80% of patients remained on study treatment with a median duration of follow-up of four months in the interim analysis of the RAMP 201 trial[110]. - The company anticipates incurring significant expenses and continuing operating losses due to ongoing research and development efforts for VS-6766 and defactinib[117]. - Research and development expenses increased by 53% to $14.9 million in the 2022 Quarter from $9.7 million in the 2021 Quarter, driven by higher contract research organization costs and drug substance costs[128]. - Research and development expenses for the six months ended June 30, 2022, were $28.5 million, up 53% from $18.6 million in the same period of 2021, mainly due to increased CRO and drug product costs[141]. Debt and Financing - The company raised $24.1 million in net proceeds from a loan and security agreement with Oxford during the 2022 Period[156]. - The company entered into a loan agreement allowing for up to $150 million in term loans, with an initial loan of $25 million funded at closing[157]. - Interest expense decreased by 65% to $0.7 million in the 2022 Period from $2.0 million in the 2021 Period, attributed to the conversion of $28.0 million principal of convertible senior notes[148]. - The company entered into a Loan Agreement on March 25, 2022, borrowing $25.0 million, with interest rates subject to fluctuations based on the one-month CME Secured Overnight Financing Rate plus a margin[193]. - The company may finance its cash needs through equity offerings, debt financings, collaborations, and licensing arrangements, which may dilute existing stockholders' interests[188]. Licensing and Agreements - The Secura APA resulted in an upfront payment of $70 million, with potential regulatory milestone payments up to $45 million and sales milestone payments up to $50 million[174]. - The company expects to receive low double-digit royalties on annual aggregate net sales above $100 million in the U.S., EU, and the UK from the Secura agreement[174]. - The company sold its COPIKTRA license and no longer sells COPIKTRA in the U.S., expecting to finance operations through future milestones and royalties[150]. - In the 2022 Period, the company recognized $2.6 million in revenue from the sale of the COPIKTRA license and related assets, primarily due to a regulatory milestone achieved by Secura's sublicensee, CSPC, amounting to $2.5 million[177]. - The company is obligated to pay Chugai a non-refundable payment of $3.0 million under the Chugai Agreement, along with double-digit royalties on net sales of products containing VS-6766[179]. - The Chugai Agreement allows Chugai to obtain opt-back rights for development and commercialization in the EU, Japan, and Taiwan, contingent upon certain conditions[180]. - The company may terminate the Chugai Agreement with 180 days' written notice, while Chugai may terminate under certain conditions related to patent challenges[182]. Operational Risks - The company expects to incur significant expenses and operating losses as it continues ongoing clinical trials for product candidates VS-6766 and defactinib, and anticipates that existing cash resources will be sufficient for at least the next twelve months[183]. - The company is subject to fluctuations in foreign currency rates due to contracts with CROs and contract manufacturers globally[192].