vTv Therapeutics Inc. — Q3 2023 Form 10-Q
Business and period. This clinical-stage pharmaceutical company focuses on metabolic and inflammatory diseases. The filing covers the quarter and nine months ended September 30, 2023; financial statements are unaudited. Its lead candidate is cadisegliatin (TTP399), an investigational adjunctive therapy to insulin for type 1 diabetes. The company has not generated product-sales revenue.
Financial highlights
Amounts below are in millions of dollars, except per-share data.
| Metric | Q3 2023 | Q3 2022 | Nine months 2023 | Nine months 2022 |
|---|---|---|---|---|
| Revenue | $0 | $0 | $0 | $2.0 |
| Research and development | $2.8 | $3.1 | $11.5 | $8.4 |
| General and administrative | $2.5 | $2.6 | $9.3 | $9.8 |
| Operating loss | $(5.4) | $(5.7) | $(20.8) | $(16.2) |
| Net loss attributable to vTv Therapeutics Inc. | $(6.7) | $(4.3) | $(16.8) | $(14.4) |
| Basic and diluted loss per Class A share | $(0.08) | $(0.05) | $(0.21) | $(0.20) |
- At September 30, cash and cash equivalents were $8.2 million, down from $12.1 million at December 31, 2022. Current assets were $10.1 million and current liabilities $10.3 million. Long-term investments were $4.4 million; the company sold its Reneo shares after quarter-end for approximately $4.4 million.
- Operating cash use for the first nine months was $16.2 million, versus $9.1 million a year earlier. Financing provided $12.3 million, principally from early repayment of the G42 promissory note; cash declined by $3.9 million.
- Reported notes payable were $0.5 million, all current. The filing also reports $18.7 million of noncurrent contract liabilities and $0.4 million of operating lease liabilities. Stockholders’ deficit was $25.2 million.
- Q3 net loss included a $4.2 million impairment of the Anteris investment, partly offset by a $0.6 million unrealized gain on Reneo shares and gains from changes in related-party warrant fair value. For the nine-month period, the Anteris impairment was offset in part by Reneo investment gains and warrant fair-value gains.
Changes and management commentary
- Year-to-date revenue fell by $2.0 million because the 2022 period included recognition of a Huadong development milestone. No revenue was recorded in the first nine months of 2023.
- Year-to-date R&D expense rose 36.5% to $11.5 million, mainly from increased cadisegliatin drug-product and trial-preparation costs. Management said trial progress and future R&D spending depend on securing additional funding.
- Management stated that existing cash was expected to fund operations into the first quarter of 2024. It was seeking financing, partnering, licensing, or program-monetization opportunities to fund operations and cadisegliatin trials into the third quarter of 2024. The company said these conditions raise substantial doubt about its ability to continue as a going concern.
- Potential financing sources include up to $37.3 million of remaining ATM capacity and additional Lincoln Park share sales, subject to market-price, trading-volume, and other limitations. These options could dilute shareholders; financing or partnership terms may also constrain operations or require relinquishing rights.
- The FDA and company had aligned on trial designs and a primary endpoint for cadisegliatin studies; management expected to initiate studies as soon as possible. The filing does not provide a specific start date or funding commitment.
- On September 25, Anteris gave notice terminating its license agreement, with termination scheduled to become effective December 24, 2023. Anteris shareholders subsequently approved its dissolution; vTv recorded a $4.2 million investment impairment. On October 30, vTv received approximately $4.4 million from selling its Reneo shares.
- Stockholders approved authority for a reverse split between 1-for-10 and 1-for-40, but the board had not selected a ratio or date as of the filing. Disclosure controls were reported effective, and the company reported no material legal proceedings or material changes to previously disclosed risk factors.
Important facts for investors to verify
- Whether vTv secures adequate financing on acceptable terms before its projected cash runway expires, and the resulting dilution or other restrictions.
- Whether the post-quarter Reneo sale proceeds were received and how they affect the company’s updated cash runway and plans.
- The timing, funding, and regulatory path for cadisegliatin trials, including whether the planned studies begin and progress as expected.
- The consequences of Anteris’s license termination and dissolution, including any remaining obligations or recoveries.
- The eventual reverse-split ratio and effective date, and the current availability and terms of ATM and Lincoln Park financing facilities.