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Verastem, Inc. (NASDAQ: VSTM) is a pioneering biopharmaceutical company dedicated to discovering and developing innovative drugs that target cancer stem cells. These cells are a significant factor in tumor recurrence and metastasis, posing a substantial challenge in the treatment of various cancers. Verastem's mission is to translate groundbreaking cancer stem cell research into new medicines that address major cancers, including breast cancer.
The core focus of Verastem lies in advancing novel anticancer agents, particularly those inhibiting critical signaling pathways that promote cancer cell survival and tumor growth. This includes the development of RAF/MEK inhibitors and FAK inhibitors. These targeted therapies are designed to intercept the mechanisms that allow cancer cells to thrive and spread, offering hope for more effective treatments.
One of the company's notable projects involves the combination of avutometinib (a RAF/MEK clamp) and defactinib (a FAK inhibitor). This drug combination has shown promising results and has been granted breakthrough therapy designation for treating recurrent low-grade serous ovarian cancer (LGSOC), regardless of KRAS status, after one or more prior lines of therapy, including platinum-based chemotherapy.
Verastem has also entered into a strategic partnership with GenFleet Therapeutics, a clinical-stage biotechnology company. This collaboration aims to advance three oncology programs, with GFH375 being the first selected candidate. GFH375, an oral KRAS G12D inhibitor, targets both the
Verastem Oncology (Nasdaq: VSTM) reported Q2 2024 financial results and business updates. Key highlights include:
1. Initiated rolling NDA submission for avutometinib and defactinib combination in recurrent low-grade serous ovarian cancer.
2. Presented positive initial interim results from RAMP 205 trial in first-line metastatic pancreatic cancer at ASCO 2024.
3. Cash position of $83.4 million as of June 30, 2024; pro forma $144.5 million including recent financing and milestone payment.
4. Q2 2024 revenue of $10 million from COPIKTRA sales milestone.
5. Net loss of $8.3 million, or $0.31 per share for Q2 2024.
6. Expects to complete NDA submission in H2 2024 and potential U.S. commercial launch in 2025.
Verastem Oncology (Nasdaq: VSTM) has received FDA Orphan Drug Designation for avutometinib and defactinib in treating pancreatic cancer. This combination therapy, along with standard chemotherapy, showed promising results in the ongoing RAMP 205 trial for first-line metastatic pancreatic cancer. Initial interim data presented at ASCO 2024 revealed an 83% confirmed partial response rate in the dose level 1 cohort. The company plans to report updated data from the trial in Q1 2025. The Orphan Drug Designation recognizes the unmet need in pancreatic cancer treatment and offers benefits such as tax credits and potential market exclusivity.
Verastem Oncology (Nasdaq: VSTM) has announced the pricing of a $55.0 million public offering of common stock, warrants, and pre-funded warrants. The offering includes 13,333,334 shares of common stock and warrants at $3.00 per share, and 5,000,000 pre-funded warrants with accompanying warrants at $2.999 each. The warrants have an exercise price of $3.50 per share and will expire in 18 months.
The company plans to use the proceeds for the potential launch of avutometinib and defactinib in LGSOC, continued clinical research and development, working capital, and other corporate purposes. Guggenheim Securities and Cantor are acting as joint book-running managers for the offering, which is expected to close on July 25, 2024.
Verastem Oncology (Nasdaq: VSTM) has announced a proposed public offering of common stock, warrants, and pre-funded warrants. The offering, subject to market conditions, aims to raise funds for various purposes including:
1. Potential launch of avutometinib and defactinib in low-grade serous ovarian cancer (LGSOC)
2. Continued clinical research and development
3. Working capital and general corporate purposes
4. Possible acquisitions
Guggenheim Securities and Cantor are acting as joint book-running managers for the offering. The securities will be offered under a shelf registration statement declared effective by the SEC on November 20, 2023.
Verastem Oncology (Nasdaq: VSTM) announced that the first patient has been dosed with GFH375/VS-7375, a KRAS G12D (ON/OFF) inhibitor, in a Phase 1/2 trial in China. Conducted by GenFleet Therapeutics, this trial is part of a collaboration established in 2023. The trial aims to evaluate GFH375/VS-7375's safety and efficacy in patients with advanced KRAS G12D mutant solid tumors. Initial preclinical data showed strong anti-tumor activity and potential for brain metastases treatment. Verastem plans to initiate development studies outside China after analyzing the Phase 1 dose escalation data.
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical firm, has announced inducement grants under Nasdaq Rule 5635(c)(4). The company granted stock options for 108,292 shares to seven new employees to incentivize their employment.
The stock options, priced at $3.25 per share, reflect the closing price on July 1, 2024. Options for 78,292 shares will vest 25% after one year, with the remaining shares vesting quarterly over three years. Meanwhile, options for 30,000 shares will vest upon meeting specific regulatory milestones, contingent on continued employment.
Verastem Oncology (Nasdaq: VSTM) announced its addition to the Russell 3000® and Russell Microcap® Indexes, effective July 1, 2024.
This inclusion reflects the company's progress, including the advancement of avutometinib combined with defactinib for recurrent low-grade serous ovarian cancer. Verastem anticipates announcing mature data from RAMP 201 and completing its rolling NDA submission in the latter half of 2024.
The company is also progressing in the clinical programs for metastatic pancreatic cancer and non-small cell lung cancer. Additionally, GenFleet has initiated a Phase 1/2 clinical trial in China for GFH375/VS-7375, targeting KRAS G12D mutations.
Russell indexes are essential benchmarks for investment managers, encompassing the 4,000 largest U.S. stocks and tracking about $10.5 trillion in assets.
GenFleet Therapeutics has received approval from China's National Medical Products Administration (NMPA) for an open-label, multi-center phase I/II clinical trial of GFH375 (VS-7375), an oral KRAS G12D (ON/OFF) inhibitor, in patients with advanced solid tumors. This trial targets the prevalent KRAS G12D mutation, with no existing G12D-targeted therapies approved. GFH375 has shown promising preclinical safety, bioavailability, and efficacy, including potential for treating brain metastases.
The study will be conducted across ~40 hospitals, including Shanghai Chest Hospital. Phase I will assess safety, tolerability, and preliminary efficacy, determining the recommended phase II dose. Phase II will evaluate efficacy in cancers such as PDAC, CRC, and NSCLC, and investigate response/resistance mechanisms.
GenFleet's collaboration with Verastem Oncology, initiated in 2023, highlights the company's advances in RAS-targeted therapies, exemplified by previous success with KRAS G12C inhibitor fulzerasib.
Verastem Oncology (Nasdaq: VSTM) has begun a rolling submission of a New Drug Application (NDA) to the FDA for accelerated approval of the avutometinib and defactinib combination. This treatment is aimed at adult patients with recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC). The submission will be completed in the second half of 2024 with mature data from the RAMP 201 trial, which shows promising response rates. Verastem plans to present this data at a medical conference and discuss potential approval paths for KRAS wild-type patients. The company will host an investor call on May 24, 2024, to provide updates.
Verastem Oncology (Nasdaq: VSTM) announced positive initial interim safety and efficacy results from its ongoing RAMP 205 Phase 1/2 clinical trial for metastatic pancreatic cancer. The trial evaluates avutometinib plus defactinib combined with gemcitabine and Nab-paclitaxel. As of May 14, 2024, in dose level 1, 83% (5/6) of patients achieved a confirmed partial response. One dose-limiting toxicity was observed but later cleared. The results will be presented at the ASCO Annual Meeting on June 1, 2024. Verastem will host a conference call on May 24, 2024, to discuss these findings.
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