Monopar Therapeutics has tons of upside, says Roth Capital

Roth Capital Partners resumed coverage on Friday on clinical-stage biopharma company Monopar Therapeutics (Monopar Therapeutics Stock Quote, Charts, News, Analysts, Financials NASDAQ:MNPR), with analyst Kumaraguru Raja issuing a “Buy” rating on the stock. 

Monopar is focused on developing therapeutics for cancer patients, with its assets including Validive, a clonidine mucobuccal tablet, in a Phase 2b/3 trial for treatment of radiation-induced severe oral mucositis; Camsirubicin, aimed at minimizing toxic effects of cancer treatment on the heart; and MNPR-101, an antibody for treating advanced solid cancers. 

Monopar gave a program update in last month’s third quarter announcement, saying its VOICE International Phase 2b/3 trial with Validive is enrolling patients and adding clinical sites, now at 73 active sites and over 130 patients dosed. Enrolment in the Phase 2b portion has been completed, while enrolment in the Phase 3 portion has begun, with an independent data monitoring board to perform an analysis on the first 130 patients, expected in the first quarter 2023, to determine whether the Phase 3 trial should continue.

On Camsirubicin, Monopar’s Phase 1b has cleared the third dose cohort and is currently enrolling patients in the fourth dose level. Results from an interim analysis were presented as a poster at a conference in mid-November, with Raja saying the data so far looks encouraging.

In other research, Monopar is conducting preclinical studies on MNPR-101to support a first-in-human study submission, while preclinical data on MNPR-202 is expected to be presented at a meeting this month.

In Monopar’s third quarter commentary, the company said it ended the Q3 with cash and equivalents of $14.3 million, which it sees as sufficient to complete the Phase 2b portion of the VOICE trial, to start the Phase 3 trial and to support the Camsirubicin trial “through at least November 2023.”

“The Company plans to raise additional funds and/or engage a partner within the next 12 months to complete the VOICE clinical program and continue camsirubicin clinical development through and beyond the ongoing open-label, dose escalation Phase 1b clinical trial,” Monopar said in a press release.

As for Raja, the analyst is pairing Roth Capital’s “Buy” rating with a 12-month price target of $18.00, which at press time represented a projected return of 584 per cent. (All figures in US dollars.)

“We arrive at our 12-month price target of $18/share by assessing the after-tax, risk-adjusted NPV of potential future cash flows from the company’s severe oral mucositis and advanced soft tissue sarcoma programs. The probability-adjusted, fully taxed (30 per cent) NPV (15 per cent discount rate) of potential cash flows through 2035 is $224 million or $18/share, by our calculation, corresponding to our 12-month price target,” Raja said.

On upcoming potential catalysts, Raja pointed to the preclinical data on MNPR-202 due this month, a decision on continuing the Validive Phase 2b trial into Phase 3, likely in Q1 2023, and additional data and a pivotal trial plan on Camsirubicin sometime in mid-2023.