Monopar Therapeutics Inc. — Q2 2021 Form 10-Q
Reporting period: Quarter and six months ended June 30, 2021. The filing was signed August 12, 2021. Monopar is a clinical-stage biopharmaceutical company with no approved products and no operating revenue.
Business context and programs
- Validive: Phase 2b/3 VOICE trial for prevention of severe oral mucositis in oropharyngeal cancer patients receiving chemoradiation. The first patient was dosed in February 2021.
- Camsirubicin: In development for advanced soft tissue sarcoma. The company reported FDA clearance in August 2021 to proceed with a Phase 1b trial and expected to dose the first patient in Q4 2021.
- MNPR-101 and related radioimmunotherapeutics: Preclinical programs targeting uPAR, including research for cancer and severe COVID-19, in collaboration with NorthStar.
- MNPR-202: Early-stage camsirubicin analog under preclinical evaluation with the Cancer Science Institute of Singapore.
Financial performance and liquidity
| Metric | Q2 2021 | Q2 2020 | Six months 2021 | Six months 2020 |
|---|---|---|---|---|
| Revenue | $0 | $0 | $0 | $0 |
| Research and development expense | $1.476 million | $0.833 million | $2.683 million | $1.177 million |
| General and administrative expense | $0.616 million | $0.632 million | $1.304 million | $1.423 million |
| Total operating expenses | $2.092 million | $1.464 million | $3.987 million | $2.600 million |
| Net loss | $2.080 million | $1.446 million | $3.964 million | $2.537 million |
| Basic and diluted loss per share | $0.17 | $0.14 | $0.32 | $0.24 |
- Q2 R&D expense rose $644,000 year over year, principally due to Validive trial costs, camsirubicin trial preparation, and increased personnel costs. Six-month R&D expense increased $1.506 million. G&A declined $119,000 for the six-month period, partly because some CEO compensation was allocated to R&D.
- At June 30, cash and cash equivalents were $24.293 million, versus $16.737 million at December 31, 2020. Total assets were $24.457 million; total liabilities were $1.104 million, consisting of current liabilities. The balance sheet reported no debt.
- Six-month operating cash use was $3.344 million, compared with $2.121 million in 2020. Financing provided $10.897 million, mainly from common-stock sales; cash increased $7.556 million. There was no investing cash flow.
- During the first half, the company sold 1,104,047 shares under its at-the-market sales agreement for net proceeds of $10.925 million. The agreement’s maximum offering amount was reached; the company did not expect further sales under it. Shares outstanding were 12,582,728 at June 30.
- Operating margins are not meaningful because the company has no revenue. Accumulated deficit was $36.149 million.
Changes, outlook, and risks
- Management estimated that available cash would fund planned operations at least through September 2022 and stated that it found no substantial doubt about going concern. This estimate is subject to assumptions and does not cover all potential development needs.
- Monopar said it planned to pursue additional financing or a Validive partnership within 12 months. Completing the VOICE program, including a possible second confirmatory Phase 3 trial, could require funding in the millions or tens of millions of dollars. Additional funding is also needed for development beyond camsirubicin Phase 1b and for other pipeline programs.
- The company anticipated the VOICE Phase 2b interim point in the first half of 2022 and Phase 3 enrollment completion in Q1 2023. In August 2021 it reported reaching 20 activated Phase 2b sites and intended to activate additional sites.
- Monopar expects continuing losses and increased R&D spending. If financing or a suitable partner is unavailable, it may delay, reduce, terminate, or out-license programs; equity financing could dilute existing shareholders.
- Key risks include clinical-trial outcomes and enrollment, regulatory and manufacturing delays, reliance on third parties, intellectual-property protection, competition, and COVID-19 effects on trials and financing. The filing reported no material changes to the risk factors in its 2020 Form 10-K.
- Potential contractual payments include up to $108 million in Validive milestones to Onxeo plus 5%–10% royalties on net sales, and up to $14.925 million in MNPR-101 milestones to XOMA. No milestones or royalties were earned or payable during the reported periods.
- No material legal claims were reported, and the company reported no off-balance-sheet arrangements. Disclosure controls were assessed as effective, with no material changes in internal control over financial reporting during the quarter.
Important facts for investors to verify
- Whether cash, spending, and access to financing remain consistent with management’s runway estimate through September 2022, particularly as clinical spending rises.
- VOICE enrollment, interim timing, trial results, and the availability and terms of financing or a partnership to complete the program.
- The actual start, enrollment, cost, and results of the camsirubicin Phase 1b trial, and funding required for subsequent development.
- Further share issuance and dilution following exhaustion of the JonesTrading sales agreement, and whether alternative financing or collaboration terms affect shareholder value.
- Whether preclinical MNPR-101, radioimmunotherapeutic, and MNPR-202 findings translate into clinical development and whether related regulatory, manufacturing, and intellectual-property risks change.