On August 8, 2022 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported financial results for the three months ended June 30, 2022, and highlighted recent progress (Press release, Verastem, AUG 8, 2022, View Source [SID1234617797]).
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"In the second quarter, we announced findings from the interim analysis of our registration-directed RAMP 201 trial in low-grade serous ovarian cancer and are encouraged by the anti-tumor activity that we have seen to date in patients with both KRAS mutant and KRAS wild-type tumors. We look forward to evaluating a more mature data set to select the go forward regimen." said Brian Stuglik, CEO of Verastem Oncology. "We also advanced our broader development program, including being honored by the Pancreatic Cancer Network as the first recipient of their Therapeutic Accelerator Award. This award will support a Phase 1b/2 clinical trial evaluating VS-6766 and defactinib in addition to standard of care chemotherapy in front-line metastatic pancreatic cancer. The goal of the trial is to increase response rate and survival through a more complete blockade of tumorigenic signaling."
Second Quarter 2022 and Recent Highlights
Low Grade Serous Ovarian Cancer (LGSOC)
Verastem Oncology completed a planned interim analysis of the registration-directed RAMP 201 trial with the goal of selecting a go forward treatment regimen of either VS-6766 monotherapy or VS-6766 in combination with defactinib. The analysis indicated encouraging efficacy results with confirmed responses by independent review in patients treated with VS-6766 monotherapy and patients treated with VS-6766 in combination with defactinib. The findings also include confirmed responses by independent review in both KRAS mutant and KRAS wild-type LGSOC. To date, there have been no additional safety signals with a continued favorable safety profile in both the monotherapy and combination treatment arms with approximately 6% of patients discontinuing due to adverse events.
With approximately 80% of patients in the RAMP 201 study remaining on study treatment with a median duration of follow-up of four months, data from the interim analysis were not mature enough to make a final decision on the go forward treatment regimen and the trial continues with all four cohorts. The Company plans to complete enrollment of all four cohorts of the trial in the second half of this year. Each cohort is expected to have approximately 36 patients for a total of 144 patients.
KRAS Mutant Non-Small Cell Lung Cancer (NSCLC)
The registration-directed RAMP 202 study investigating VS-6766 alone and in combination with defactinib continues to enroll patients with V600E or non-V600E BRAF mutations. Planned enrollment is complete in the selection phase (Part A; n=32) in patients with KRAS G12V-mutant NSCLC. Enrollment has also been completed in the non-G12V mutant cohort in the selection phase (Part A). The Company expects to report topline results from Part A, initiate Part B and discuss the data with regulatory authorities during the second half of 2022.
The Phase 1/2 RAMP 204 clinical trial evaluating VS-6766 in combination with Mirati’s adagrasib in KRAS G12C-mutant NSCLC opened and is enrolling participants.
The Phase 1/2 RAMP 203 clinical trial evaluating VS-6766 in combination with Amgen’s LUMAKRASTM (sotorasib) in KRAS G12C-mutant NSCLC continues to enroll and initial results are expected to be reported during the second half of 2022.
Corporate Updates
The U.S Patent and Trademark Office has granted Patent No. 11,400,090 which covers the novel, intermittent twice-weekly dosing regimen used in the VS-6766 development program. This extends the current patent protection for VS-6766 in RAS-driven cancers (KRAS/NRAS/HRAS mutations) to 2038.
The Company received the first "Therapeutic Accelerator Award" from the Pancreatic Cancer Network (PanCAN). The award will support a Phase 1b/2 clinical trial of the Company’s lead investigational candidates, RAF/MEK Clamp, or VS-6766, with FAK inhibitor, defactinib to evaluate whether a more complete blockade of KRAS signaling in addition to standard of care chemotherapy will improve outcomes for patients with front-line metastatic pancreatic cancer. KRAS mutations occurs in more than 95% of pancreatic cancer tumors.
Results from a Phase 1 investigator-initiated trial evaluating RAF/MEK clamp VS-6766 in combination with everolimus presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) found encouraging responses across various RAS-driven tumor types as well as a tolerable intermittent dosing schedule. The data also included a median progression-free survival interval of 6.3 months in KRAS mutant NSCLC and median progression-free survival of 35.8 and 41.8 months in two enrolled patients with KRAS mutant LGSOC, respectively. The trial is continuing with an ongoing expansion cohort for patients with KRAS mutant NSCLC.
Second Quarter 2022 Financial Results
Verastem Oncology ended the second quarter 2022 with cash, cash equivalents and investments of $94.3 million. With proceeds available upon achievement of certain milestones from the Oxford Finance LLC credit facility and expected milestones and royalties from the sale of COPIKTRA, Verastem Oncology expects that it has a cash runway until at least 2025 to deliver on the current programs for VS-6766 and defactinib, including expenditures and development in LGSOC and KRAS mutant NSCLC.
Total revenue for the three months ending June 30, 2022 (2022 Quarter) was $0.0 million, compared to $0.5 million for the three months ended June 30, 2021 (2021 Quarter).
Total operating expenses for the 2022 Quarter were $21.4 million, compared to $16.4 million for the 2021 Quarter.
Research & development expenses for the 2022 Quarter were $14.9 million, compared to $9.7 million for the 2021 Quarter. The increase of $5.2 million, or 53.6%, primarily resulted from an increase in drug product and drug substance costs, contract research organization costs and investigator fees.
Selling, general & administrative expenses for the 2022 Quarter were $6.5 million, compared to $6.7 million for the 2021 Quarter. The decrease of $0.2 million, or 3.0%, primarily resulted from lower consulting and professional fees.
Net loss for the 2022 Quarter was $22.0 million, or $0.12 per share (basic and diluted), compared to net loss of $16.9 million, or $0.10 per share (basic and diluted), for the 2021 Quarter.
For the 2022 Quarter, non-GAAP adjusted net loss was $20.1 million, or $0.11 per share (diluted), compared to non-GAAP adjusted net loss of $14.0 million, or $0.08 per share (diluted), for the 2021 Quarter. Please refer to the GAAP to Non-GAAP Reconciliation attached to this press release.
Use of Non-GAAP Financial Measures
To supplement Verastem Oncology’s condensed consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in the United States (GAAP), the Company uses the following non-GAAP financial measures in this press release: non-GAAP adjusted net (loss) income and non-GAAP net (loss) income per share. These non-GAAP financial measures exclude certain amounts or expenses from the corresponding financial measures determined in accordance with GAAP. Management believes this non-GAAP information is useful for investors, taken in conjunction with the Company’s GAAP financial statements, because it provides greater transparency and period-over-period comparability with respect to the Company’s operating performance and can enhance investors’ ability to identify operating trends in the Company’s business. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of the Company’s operating results as reported under GAAP, not in isolation or as a substitute for, or superior to, financial information prepared and presented in accordance with GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures for the three and six months ended June 30, 2022, and 2021 are included in the tables accompanying this press release after the unaudited condensed consolidated financial statements.
About VS-6766
VS-6766 (formerly known as CH5126766 and RO5126766) is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF potentially creating a more complete and durable anti-tumor response through maximal RAS pathway inhibition. VS-6766 is currently in late-stage development.
In contrast to other MEK inhibitors, VS-6766 blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows VS-6766 to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors. The U.S. Food and Drug Administration granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK inhibitor VS-6766, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.1
Verastem Oncology is conducting Phase 2 registration-directed trials of VS-6766 alone and with defactinib in patients with recurrent LGSOC and in patients with recurrent KRAS G12V-mutant NSCLC as part of its RAMP (Raf And Mek Program) clinical trials, RAMP 201 and RAMP 202, respectively. Verastem Oncology has also established clinical collaborations with Amgen and Mirati to evaluate LUMAKRAS (sotorasib) and adagrasib in combination with VS-6766 in KRAS G12C-mutant NSCLC as part of the RAMP 203 and RAMP 204 trials, respectively.