Business context and reporting period
Monopar Therapeutics Inc. is a clinical-stage biopharmaceutical company developing four oncology-focused candidates: Validive, camsirubicin, MNPR-101 and MNPR-202. This unaudited Form 10-Q covers the quarter and six months ended June 30, 2022.
The company had no approved products and generated no revenue. Its principal programs were Validive, in the Phase 2b/3 VOICE trial; camsirubicin, in a Phase 1b dose-escalation trial; and preclinical MNPR-101-derived radioimmunotherapeutics and MNPR-202.
Financial highlights
| Metric | Q2 2022 | Q2 2021 | Six months 2022 | Six months 2021 |
|---|---|---|---|---|
| Revenue | None | None | None | None |
| Research and development expense | $2.08 million | $1.48 million | $3.76 million | $2.68 million |
| General and administrative expense | $0.68 million | $0.62 million | $1.46 million | $1.30 million |
| Total operating expenses / operating loss | $2.76 million | $2.09 million | $5.22 million | $3.99 million |
| Net loss | $2.76 million | $2.08 million | $5.22 million | $3.96 million |
| Net loss per share, basic and diluted | $0.22 | $0.17 | $0.41 | $0.32 |
| Net cash used in operating activities | Not presented quarterly | Not presented quarterly | $3.78 million | $3.34 million |
Gross margin and operating margin are not meaningful because the company had no revenue. Cash and cash equivalents were $16.46 million at June 30, 2022, down from $20.30 million at December 31, 2021. Total assets were $16.74 million; current liabilities were $2.19 million. The balance sheet reported no debt. Accumulated deficit was $46.51 million.
Six-month financing cash flow was a use of $0.08 million, compared with $10.90 million provided in the prior-year period, which included ATM stock-sale proceeds. There was no investing cash flow in either period.
Material changes versus prior comparable periods
- Q2 net loss rose by about $0.68 million year over year; six-month net loss rose by about $1.26 million.
- R&D expense increased $0.60 million in Q2 and $1.07 million for the six months, mainly reflecting higher Validive and camsirubicin trial and manufacturing costs. G&A expense increased $0.07 million in Q2 and $0.16 million for the six months, primarily due to salaries and benefits.
- Operating cash use increased $0.43 million for the six months. Cash declined $3.84 million during the first half of 2022, whereas it increased $7.56 million in the first half of 2021, largely because of prior-year equity-sale proceeds.
- The company recorded operating lease assets and liabilities in 2022 for additional office space; total lease liability was $80,125 at quarter-end.
Outlook, commentary and risks
- Management estimated available funds would support planned operations at least through September 30, 2023, and stated there was no substantial doubt about the company’s ability to continue as a going concern. This estimate does not mean existing funds are sufficient to complete all development programs.
- Additional funding is expected within 12 months. Completing the Validive VOICE program, including a possible second confirmatory Phase 3 trial, is expected to require funding in the millions or tens of millions of dollars, depending on a collaboration or partnership. The company said it may need to curtail or terminate programs if it cannot secure financing or a suitable partner.
- Management anticipated a Validive interim analysis in Q1 2023. As of July 29, 2022, 58 VOICE trial sites were activated. The company planned to seek additional capital and/or a Validive partner.
- The camsirubicin Phase 1b trial had advanced to its fourth dose level. Management expected topline results by September 2023, but noted that higher-than-anticipated dose escalation could extend the trial and require additional funding. Further development beyond Phase 1b will require additional funding.
- The company reported progress with NorthStar on MNPR-101 radioimmunotherapeutic and diagnostic candidates and was evaluating pathways to a first-in-human study. MNPR-202 remained in preclinical evaluation.
- Risks include clinical-trial, regulatory and manufacturing uncertainty; dependence on third parties; financing and dilution risk; competition and intellectual-property risks; and possible COVID-19- or Russia-Ukraine-related disruption to trials, shipping, costs or financing.
- 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 as of June 30, 2022. No legal claims had been asserted.
- The new JonesTrading ATM permits up to $4.87 million of stock sales; no shares had been sold under it by the filing date. Future sales could dilute shareholders or affect the share price.
Important facts for investors to verify
- Whether the cash-runway estimate through September 2023 remains supportable as trial spending rises, and what financing or partnership has been secured.
- VOICE enrollment, the planned Q1 2023 interim analysis, its results and the funding required for any Phase 3 or confirmatory trial.
- Camsirubicin dose-escalation progress, trial timing and whether results or further development require additional capital.
- Actual use of the $4.87 million ATM, potential dilution and any other financing or collaboration terms.
- Progress toward human testing of MNPR-101-derived candidates and results from MNPR-202 preclinical work.