WILMETTE, Ill., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients, today announced second quarter 2023 financial results and summarized recent developments.
Recent Developments
Camsirubicin – Phase 1b Dose-Escalation Trial, Treating Fifth Dose-Level Cohort (650 mg/m2)
MNPR101 for Radiopharmaceutical Use – Promising Preclinical Studies Support First in Human Study
MNPR202 Promising Preclinical Data Ignite Further Research
Results for the Second Quarter Ended June 30, 2023 Compared to the Second Quarter Ended June 30, 2022
Cash and Net Loss
Cash, cash equivalents and short-term investments as of June 30, 2023 were $10.2 million. Monopar expects that its current funds will be sufficient for Monopar to obtain topline results from its ongoing open-label Phase 1b camsirubicin clinical trial by mid-2024 (but this may not be the case if camsirubicin reaches even higher dose levels than anticipated and topline results are deferred as dosing continues beyond mid-2024), advance the Company’s MNPR-101 radiopharmaceutical program into its first-in-human clinical trial, and close out Monopar’s terminated Validive Phase 2b/3 (VOICE) clinical program. The Company estimates its cash, cash equivalents and short-term investments will fund the Company’s planned operations at least through September 2024. Monopar will require additional funding to advance its clinical and preclinical programs beyond that and anticipates seeking to raise additional capital within the next 12 months to fund its future operations.
Net loss for the second quarter of 2023 was $2.2 million or $0.16 per share compared to net loss of $2.8 million or $0.22 per share for the second quarter of 2022.
Research and Development (R&D) Expenses
R&D expenses for the three months ended June 30, 2023 were $1,595,000, compared to $2,078,000 for the three months ended June 30, 2022. This represents a decrease of $483,000 primarily attributed to (1) a decrease of $606,000 in camsirubicin clinical trial expenses and manufacturing-related expenses, and (2) a decrease of $68,000 in Validive clinical trial and manufacturing-related expenses. These decreases were partially offset by (1) a $99,000 increase in non-clinical studies related to MNPR-101-Zr and MNPR-101-RIT activity, and (2) an increase of $112,000 in R&D personnel and consulting expenses.
General and Administrative (G&A) Expenses
G&A expenses for the three months ended June 30, 2023 were $733,000, compared to $685,000 for the three months ended June 30, 2022. This represents an increase of $48,000 primarily attributed to an increase in G&A salaries and benefits.
About Monopar Therapeutics
Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients. Monopar's pipeline consists of camsirubicin (Phase 1b) for the treatment of advanced soft tissue sarcoma; MNPR101, a late-stage preclinical antibody for radiopharmaceutical use in advanced cancers; and MNPR202, an early-stage camsirubicin analog for various cancers. For more information, and links to SEC filings that contain detailed financial information, visit: https://ir.monopartx.com/quarterly-reports.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of these forward-looking statements include statements concerning: that both Phase 1b camsirubicin patients are set to receive additional cycles of camsirubicin treatment, which may result in further tumor size reduction; that both the MNPR-101 imaging and therapeutic agents are showing promise in preclinical studies and moving toward first-in-human studies potentially as early as the end of this year ; the timing and cost of the Phase 1b camsirubicin clinical trial, MNPR-101 radiopharma program and MNPR-202; and that the Company’s cash, cash equivalents and short-term investments will be sufficient to fund planned operations at least through September 2024. The forward-looking statements involve risks and uncertainties including, but not limited to: not successfully recruiting patients and initiating additional clinical trial sites for the camsirubicin Phase 1b clinical trial within expected timeframes, if at all; the camsirubicin trial data being inconclusive or negative; the Company’s inability to raise sufficient funds or engage a partner to continue the camsirubicin clinical program through and beyond the Phase 1b clinical trial and to further develop MNPR-101-Zr and MNPR-101-RIT with its collaboration partners; the effects of general economic and market conditions on Monopar’s operations and ability to raise funding, including potential ramifications due to recent instability in the banking industry; whether the Company will remain in compliance with Nasdaq listing standards with regard to its stock price and if the Company becomes non-compliant, whether the Company will regain compliance within Nasdaq’s time limits and requirements and its effect on the Company’s ability to raise funds; and the significant general risks and uncertainties surrounding the research, development, regulatory approval, and commercialization of therapeutics and imaging agents. Actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Monopar's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Monopar undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Any forward-looking statements contained in this press release represent Monopar’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
Contact
Kim R. Tsuchimoto
Chief Financial Officer
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Follow Monopar on social media for updates:
@MonoparTx Monopar Therapeutics
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