Monopar Therapeutics Inc. — Q3 2021 Form 10-Q
Reporting period: Three and nine months ended September 30, 2021. Monopar is a clinical-stage biopharmaceutical company with no approved products and no operating revenue.
Financial position and results
| Metric | Q3 / September 30, 2021 | Comparable period / prior balance |
|---|---|---|
| Revenue | None | None |
| Operating expenses | $2.459 million for Q3; $6.446 million for nine months | $1.648 million and $4.248 million, respectively, in 2020 |
| Net loss | $2.458 million for Q3; $6.423 million for nine months | $1.639 million and $4.176 million, respectively, in 2020 |
| Cash and cash equivalents | $22.342 million | $16.737 million at December 31, 2020 |
| Operating cash flow | $(5.285) million for nine months | $(3.422) million in 2020 |
| Financing cash flow | $10.887 million for nine months | $8.189 million in 2020 |
| Total liabilities | $1.240 million; all current | $1.177 million at December 31, 2020 |
Q3 loss per share was $0.20 versus $0.15 in Q3 2020; nine-month loss per share was $0.52 versus $0.39. No debt was reported. Gross margin is not applicable because the company had no revenue. Accumulated deficit was $38.608 million at September 30, 2021.
Changes and funding
- Research and development expense rose 46% in Q3 and 85% for the nine-month period, primarily from Validive trial costs, personnel and camsirubicin trial preparation. General and administrative expense rose 61% in Q3 and 7% for nine months.
- Operating cash use increased by $1.864 million year over year for the nine-month period, reflecting higher operating expenses.
- During the first nine months, Monopar raised $10.925 million net from its at-the-market stock sales, issuing 1,104,047 shares. The $19.7 million aggregate sales authorization was fully used; no further sales under that agreement were expected. No shares were sold under it in Q3.
- Management estimated available cash would fund obligations through December 2022 and reported no substantial doubt about going concern. This estimate depends on assumptions; further funding is needed for development plans.
Programs, outlook and risks
- Validive: The Phase 2b/3 VOICE trial had dosed its first patient in February; 20 Phase 2b sites were activated by August, and authorization to proceed in multiple European countries was received in September. Management anticipated Phase 2b interim completion in the first half of 2022 and Phase 3 enrollment completion in the first half of 2023. Completing the program, including a possible confirmatory Phase 3 trial, requires additional funding in the millions or tens of millions of dollars, depending on partnership arrangements.
- Camsirubicin: The U.S. Phase 1b trial was initiated in September, with first patients dosed in October. Management said current funds were sufficient to obtain topline Phase 1b results, but additional funding would be needed for later development. A planned GEIS-led Phase 2 study is expected to require Monopar support averaging approximately $2–3 million per year.
- Other pipeline: MNPR-101 radioimmunotherapeutic and diagnostic work continued with NorthStar and other collaborators; related expenses were described as immaterial through October 31. A collaboration with Singapore’s Cancer Science Institute was evaluating MNPR-202 and related analogs in preclinical models.
- Management expected losses and expenses to increase. Funding options include equity, debt, collaborations and grants; inability to secure capital or a suitable partner could delay, reduce or terminate programs. Equity financing would dilute shareholders, while partnering could require surrendering valuable rights.
- Risks include clinical and regulatory uncertainty, trial enrollment and execution, reliance on third parties, competition, intellectual property and licensing risks, and possible COVID-19 effects on trials and financing. The filing reported no material change to previously disclosed risk factors, no asserted legal claims and no off-balance-sheet arrangements.
Important facts for investors to verify
- Actual cash runway versus the December 2022 estimate, and the timing, amount and terms of additional financing or partnerships.
- VOICE enrollment, interim data timing, Phase 3 progression and any need for a confirmatory trial.
- Camsirubicin Phase 1b progress and the funding and expected obligations associated with subsequent trials.
- Quarterly cash burn, rising R&D costs, and the effects of future equity issuance and outstanding stock-based awards on dilution.
- Whether development and collaboration milestones are achieved; disclosed potential payments include up to $108 million to Onxeo for Validive and up to $14.925 million to XOMA for MNPR-101, contingent on milestones.