vTv Therapeutics Inc. — Q1 2022 Form 10-Q
Reporting period: Three months ended March 31, 2022; unaudited consolidated results. vTv is a clinical-stage pharmaceutical company focused on metabolic and inflammatory diseases. It has not generated product sales.
Key financial results
| Metric | Q1 2022 | Q1 2021 / comparison |
|---|---|---|
| Revenue | $2.0 million | $1.0 million; increase of $1.0 million |
| Research and development | $3.1 million | $3.1 million; broadly unchanged |
| General and administrative | $5.3 million | $2.2 million; up $3.2 million |
| Operating loss | $6.5 million | $4.3 million |
| Net loss before noncontrolling interest | $9.4 million | $5.9 million |
| Net loss attributable to vTv | $7.0 million; $0.10 per share | $4.2 million; $0.08 per share |
| Net cash used in operating activities | $1.0 million | $5.3 million |
Q1 2022 revenue was a $2.0 million development milestone under the Huadong license agreement, recognized because the related performance obligation was already satisfied. The prior-year revenue reflected a contract amendment and cumulative revenue reallocation. One customer accounted for all revenue in both periods. No product-sale revenue was reported.
G&A increased mainly due to $2.3 million more legal expense and $0.8 million of severance costs. R&D spending on TTP399 rose $2.2 million, substantially offset by lower spending on azeliragon and HPP737. Other expense included a $3.2 million unrealized loss on Reneo shares, partly offset by a $0.5 million gain from a lower fair value of related-party warrants.
Financial position and liquidity
- Cash and cash equivalents were $12.1 million at March 31, 2022, down from $13.4 million at year-end 2021. Long-term investments were $5.9 million, including $1.7 million in Reneo stock and $4.2 million in Anteris preferred stock.
- Total assets were $20.2 million; current assets were $13.6 million and current liabilities were $12.7 million. Accounts payable and accrued expenses were $12.5 million.
- Total liabilities were $13.9 million. No notes payable remained at quarter-end; the company repaid $0.3 million during the quarter. Lease liabilities totaled $0.6 million. The filing reports no material interest-rate exposure.
- Operating cash use was lower than the prior year primarily because of working-capital changes, including a $4.4 million increase in accounts payable and accrued expenses. Financing used $0.3 million, and cash declined by $1.3 million.
- Accumulated deficit was $247.7 million. Management stated that available capital, based on current operating plans, was expected to fund operations into Q4 2022 and concluded that substantial doubt exists about the company’s ability to continue as a going concern.
Developments, outlook, and risks
- The company plans two pivotal, placebo-controlled TTP399 trials in type 1 diabetes, targeting approximately 1,000 patients in total; at least one trial is planned to last one year. Trials were expected to start in Q3 2022. The FDA granted TTP399 Breakthrough Therapy Designation and agreed with the proposed primary endpoint: difference in hypoglycemia events versus placebo.
- Management said a mechanistic study found no increase in ketone levels during acute insulin withdrawal in TTP399-treated patients. The filing describes these findings as supportive; pivotal efficacy and safety outcomes remain uncertain.
- The company is seeking licensing transactions for TTP399 outside North America and Europe and for HPP737 and other assets, and is evaluating financing options, including direct equity investment. It may also use the remaining $37.3 million under its ATM agreement and its Lincoln Park purchase facility. Availability depends on market price, trading volume, and contractual limits; equity financing could dilute shareholders.
- Management expects continuing losses and significant R&D spending, but says development plans and costs depend on trial progress, enrollment, regulatory decisions, and access to funding. The company may need to delay, reduce, or discontinue programs if it cannot raise capital on acceptable terms.
- CEO Deepa Prasad resigned effective March 29, 2022; Richard S. Nelson became Interim CEO. The company reported no material legal proceedings and no material changes to previously disclosed risk factors.
Important facts for investors to verify
- Whether the company secures additional financing or licensing proceeds in time to extend its stated Q4 2022 runway, and the resulting dilution or commercial rights granted.
- Whether the planned pivotal TTP399 trials began on schedule, their enrollment and costs, and subsequent FDA feedback or clinical results.
- Whether the one-customer revenue concentration continues and whether future milestone or collaboration revenue is earned.
- How Reneo’s market value, related-party warrant valuation, and elevated legal and severance costs affect future reported results.
- Potential obligations under licenses, including Novo Nordisk development, regulatory, and sales milestones and royalties if applicable.