Monopar Therapeutics — Q1 2022 Form 10-Q
Reporting period: Three months ended March 31, 2022; balance-sheet comparisons are with December 31, 2021. Monopar is a clinical-stage biopharmaceutical company with no approved products or product revenue.
Financial performance and position
| Metric | Q1 2022 | Q1 2021 / prior period |
|---|---|---|
| Revenue | None | None |
| Research and development expense | $1.678 million | $1.207 million |
| General and administrative expense | $0.779 million | $0.688 million |
| Total operating expenses | $2.457 million | $1.895 million |
| Net loss | $2.457 million | $1.884 million |
| Basic and diluted net loss per share | $0.19 | $0.16 |
| Net cash used in operating activities | $2.468 million | $1.938 million |
| Cash and cash equivalents | $17.819 million at March 31, 2022 | $20.304 million at December 31, 2021 |
| Total liabilities | $1.099 million | $1.581 million at December 31, 2021 |
No product-revenue margins are applicable. The filing reports no borrowings or debt; liabilities primarily comprise payables, accruals and operating lease obligations. Current assets were $18.013 million versus current liabilities of $1.074 million at quarter-end.
Changes versus the prior comparable period
- Net loss increased by $0.573 million, while operating expenses increased by $0.562 million.
- R&D expense rose $0.471 million, mainly from Validive trial and manufacturing costs and personnel costs, including stock-based compensation. G&A expense rose $0.091 million, primarily due to salaries and benefits.
- Operating cash use increased by $0.529 million. Financing cash flow was a $0.017 million outflow in Q1 2022, compared with $10.921 million of financing inflows in Q1 2021, when the company sold shares through an at-the-market program.
- Stockholders’ equity declined to $16.967 million from $18.941 million at year-end. The company reported $0.500 million of non-cash stock-based compensation in Q1 2022.
Programs, outlook and key risks
- Validive: The Phase 2b/3 VOICE trial had 44 active, enrolling sites in the U.S. and Europe. An interim analysis was anticipated in the second half of 2022. Completing the program, including a possible confirmatory Phase 3 trial, was expected to require additional funding in the millions or tens of millions of dollars, depending on partnership arrangements.
- Camsirubicin: The Phase 1b dose-escalation trial was enrolling patients at the fourth dose level. Management expected topline results by June 2023, but said higher dose escalation could extend the trial and require additional funding. A GEIS-led Phase 2 trial was contemplated after Phase 1b completion.
- MNPR-101: Monopar and NorthStar were evaluating radioimmunotherapeutic and diagnostic candidates, including MNPR-101-PCTA, and assessing a potential first-in-human study.
- MNPR-202: Preclinical testing with the Cancer Science Institute of Singapore was ongoing; results were awaited.
- Management estimated available cash would fund planned operations at least through June 2023 and support obtaining camsirubicin Phase 1b topline results as planned and completing Validive Phase 2b and commencing Phase 3. This estimate depends on assumptions; substantial additional financing is needed to advance programs. The company stated it had no substantial doubt about its ability to continue as a going concern based on its cash assessment through June 2023.
- On April 20, 2022, the company established a new JonesTrading at-the-market sales agreement for up to $4.870 million; no shares had been sold under it as of the filing. Equity issuance could dilute shareholders, and the company said this facility alone would not meet its expected funding needs.
- Risks include clinical, regulatory, manufacturing, patient-enrollment and financing uncertainty; reliance on third parties; potential dilution or unfavorable partnership terms; and possible cost or shipping impacts from COVID-19 and the Russia-Ukraine conflict. The Validive license includes potential milestones of up to $108 million and royalties of 5%–10% on net sales; no milestones had been reached as of March 31, 2022.
Important facts for investors to verify
- Cash runway assumptions and the timing, amount and terms of financing or any Validive partnership.
- VOICE enrollment, interim-analysis timing and whether the trial design or need for a confirmatory Phase 3 changes.
- Camsirubicin dose-escalation progress, safety findings, trial duration and topline-results timing.
- Actual proceeds and dilution from the $4.870 million ATM facility and any additional capital raises.
- Progress toward first-in-human evaluation of MNPR-101-derived candidates and results from MNPR-202 preclinical studies.