Filing summary
Entity mismatch: The request identifies Tempest Therapeutics, Inc., but the supplied Form 10-Q is for Millendo Therapeutics, Inc. (ticker MLND), for the quarter ended March 31, 2019. This summary reflects the supplied filing, not a Tempest filing.
Business context and reporting period
Millendo was a clinical-stage biopharmaceutical company developing treatments for rare endocrine diseases. Its lead candidates were livoletide for Prader-Willi syndrome (PWS) and nevanimibe for classic congenital adrenal hyperplasia (CAH), with nevanimibe also under investigation for Cushing’s syndrome. The company had no approved products and no product-sales revenue. Results are for the three months ended March 31, 2019; the 2018 comparison reflects Private Millendo before the December 2018 reverse merger, which affects comparability.
Key financial metrics
| Metric | Q1 2019 | Q1 2018 / comparison |
|---|---|---|
| Revenue | No product-sales revenue | No product-sales revenue |
| Research and development expense | $6.2 million | $2.8 million; up 124% |
| General and administrative expense | $4.5 million | $1.6 million; up 175% |
| Operating loss | $10.7 million | $4.4 million |
| Net loss | $10.4 million | $4.4 million |
| Net loss per share | $0.78 | $6.00; comparison affected by post-merger share structure |
| Cash used in operating activities | $10.6 million | $5.0 million |
| Cash, cash equivalents and marketable securities | $67.0 million at March 31, 2019 | $77.7 million at December 31, 2018 |
| Total debt | Approximately $0.5 million outstanding | Quarterly principal repayments: $45,000 |
Operating cash burn increased year over year. No product gross margin was reported because the company had no product sales. The filing reports total assets of $74.3 million, total liabilities of $10.6 million, and stockholders’ equity of $63.7 million at quarter-end.
Material changes and developments
- R&D expense rose mainly because of increased livoletide development costs, clinical and preclinical work, and higher personnel expense. Livoletide-related expense was $3.0 million, versus $0.4 million in Q1 2018; nevanimibe expense was $0.8 million, versus $1.3 million.
- G&A expense increased primarily with public-company professional fees, staffing and stock compensation, insurance, and facilities.
- In March 2019, Millendo initiated a pivotal Phase 2b/3 livoletide PWS trial. Topline results from its Phase 2b portion were expected in the first half of 2020.
- The company adopted lease accounting guidance effective January 1, 2019, recognizing $1.8 million of lease liabilities and a $0.8 million right-of-use asset at March 31.
Outlook, risks and unusual items
- Management said existing cash, cash equivalents and marketable securities were expected to fund current operating plans into the second half of 2020, including through the expected livoletide Phase 2b topline results. The company anticipated needing additional capital over time.
- In April 2019, it entered an at-the-market equity distribution agreement allowing sales of up to $50 million of common stock; the filing does not report proceeds from the facility.
- The CAH Phase 2b trial had a tolerability issue at its initial 1,000 mg twice-daily dose: three of six subjects discontinued after non-serious adverse events. Enrollment was to pause while Millendo sought approval for a protocol amendment to begin at a lower dose and escalate. The timing impact was still being evaluated.
- Management cited clinical, regulatory, enrollment, manufacturing, funding and commercialization uncertainties; the company could delay or curtail programs if it could not raise capital. The Cushing’s syndrome study also faced slower-than-expected enrollment.
- Several legacy OvaScience shareholder lawsuits remained pending or stayed, and the company could not estimate potential losses for certain matters. It was negotiating attorneys’ fee demands related to merger-related suits.
- Disclosure controls were judged effective at a reasonable-assurance level. The filing also notes that management had not completed the prior year-end internal-control assessment following the merger and planned its first assessment for December 31, 2019.
Investor verification points
- Confirm the intended issuer: the supplied filing is Millendo Therapeutics, not Tempest Therapeutics.
- Check the livoletide trial’s enrollment, protocol and first-half-2020 topline schedule, and whether results support further development.
- Track regulatory and ethics committee decisions and the revised dosing plan for the CAH Phase 2b trial, including tolerability at higher doses.
- Monitor quarterly cash burn, ATM share sales and dilution, and whether the stated runway remains adequate.
- Review developments in legacy litigation and the planned internal-control assessment.