Business Context and Reporting Period
This Form 8-K Current Report was filed by Syndax Pharmaceuticals, Inc. on May 23, 2017. The filing primarily addresses the commencement of a public offering of common stock and provides updates on the clinical progress of the Company's lead drug candidate, entinostat, specifically within the ENCORE 601 and ENCORE 602 trials.
Key Financial Metrics
The filing does not provide specific revenue, profit, cash flow, margin, or debt figures. The primary financial event disclosed is the initiation of an underwritten public offering of $50,000,000 of the Company's common stock.
Material Changes and Clinical Developments
- Public Offering: On May 23, 2017, the Company commenced a public offering of $50,000,000 of common stock.
- NSCLC Cohort (ENCORE 601): The non-small cell lung cancer (NSCLC) cohort for patients with disease progression on or after PD-1 therapy met the prespecified objective response threshold. The cohort will re-open to enroll a total of 56 patients. Initial results are expected in Q4 2017, with enrollment completion anticipated in H1 2018.
- Melanoma Cohort (ENCORE 601): The first cohort of 13 melanoma patients who progressed on prior immune checkpoint inhibitor therapy met the criteria to advance to the second stage of the trial. Four patients (31% Objective Response Rate) achieved an objective response. Three patients remained on treatment without progression as of the data cutoff.
Guidance, Outlook, and Risks
Future Milestones:
- Q4 2017: Presentation of initial results from the NSCLC cohort and correlative biomarker data from the melanoma cohort.
- H1 2018: Presentation of results from Stage 2 of the melanoma and NSCLC cohorts and Stage 1 of the colorectal cohort.
- H2 2018: Presentation of efficacy and safety data from the Phase 2 portion of the ENCORE 602 trial.
Risks and Contingencies:
- The completion of the $50 million public offering is subject to market conditions and customary closing conditions; there is no assurance the offering will be completed on anticipated terms or at all.
- The report contains forward-looking statements regarding clinical trial timing and outcomes, which are subject to significant risks and uncertainties.
Investor Verification Checklist
- Verify the final closing status and net proceeds of the $50,000,000 public offering.
- Monitor the Q4 2017 data presentation for the NSCLC cohort to confirm the durability of the initial response.
- Review the full clinical data release for the melanoma cohort to assess the long-term safety and efficacy profile beyond the initial 13 patients.
- Check subsequent filings for updates on the decision to expand the PD-1/PD-L1 naive NSCLC cohort.