Monopar Therapeutics Reports First Quarter 2024 Financial Results and Strategic Focus on its Radiopharma Pipeline
Monopar Therapeutics Inc. reported its first-quarter 2024 financial results and a strategic focus on its radiopharma pipeline. The company initiated the MNPR-101-Zr Phase 1 clinical trial and aims to launch the MNPR-101-RIT Phase 1 trial by Q4 2024 or Q1 2025. Monopar is winding down non-radiopharma programs to concentrate resources on radiopharma assets. The company is well-funded till at least June 30, 2025, with a net loss of $1.6 million for Q1 2024. R&D expenses decreased, while G&A expenses saw a slight drop.
Monopar is making significant progress in its radiopharma programs, with promising preclinical data and entry into clinical trials.
The Company has initiated the first-in-human Phase 1 imaging and dosimetry clinical trial with MNPR-101-Zr, led by renowned radiopharmaceutical physician Prof. Rodney Hicks.
Monopar's radiopharma programs have shown optimized imaging and therapeutic capabilities, with high tumor uptake and minimal healthy tissue uptake.
The Company filed a provisional patent application to protect advancements in its MNPR-101 radiopharma programs.
Monopar reported a net loss of $1.6 million for Q1 2024, indicating ongoing financial challenges.
The Company will require additional funding to advance its preclinical and clinical programs beyond June 30, 2025, potentially leading to future dilution for shareholders.
Monopar Therapeutics' reported cash position of
The decrease in General and Administrative expenses by
The strategic focus on the radiopharmaceutical pipeline by Monopar is indicative of the high potential and growth within this sector. Initiating a first-in-human Phase 1 trial for MNPR-101-Zr is a significant milestone, given the radiopharmaceutical market's demand for innovative cancer therapies. The company's decision to wind down non-radiopharma programs highlights its commitment to this sector and will likely reallocate resources to more promising areas.
The positive preclinical data and the provisional patent application for MNPR-101 radiopharma programs are promising but require further validation in clinical settings. Investors should monitor the progress of the Phase 1 trial closely, as it will provide initial insights into the efficacy and safety profile of the candidate, which are critical drivers for future valuation. The anticipation of initiating a therapeutic radiopharmaceutical Phase 1 clinical study further extends the pipeline's depth and aligns with industry trends towards targeted cancer treatments.
Monopar's emphasis on the radiopharma segment comes at a time when the market is recognizing the value of targeted therapies in oncology. Recent acquisitions within the space signal a strong commercial interest and validate the strategic direction the company has taken. As such, Monopar's specialized focus might position it favourably for potential partnerships or acquisition talks, an aspect that could influence investor sentiment.
The closure of other clinical programs may raise concerns about the company's portfolio diversification. However, the strong market dynamics of radiopharmaceuticals, combined with a clear strategic focus, can make for a compelling narrative for growth-oriented investors. Market conditions and competitor advancements will be influential in determining Monopar's relative positioning in the growing niche of radiopharma oncology treatments.
Initiated MNPR-101-Zr First-in-Human Phase 1 Radiopharma Clinical Trial
MNPR-101-RIT Phase 1 Clinical Trial Targeted for Launch as Early as Q4 2024 or Q1 2025
WILMETTE, Ill., May 09, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage radiopharmaceutical company focused on developing innovative treatments for cancer patients, today announced first quarter 2024 financial results and summarized recent developments.
Recent Developments
The radiopharma space has had numerous positive recent developments and announcements, from acquisitions to clinical data to reimbursement rates to commercial demand. Since this past December alone, four significant acquisitions have been publicly announced or completed which have had upfront payments ranging from approximately
Monopar has been generating promising preclinical data, and recently entered the clinic with its novel, proprietary MNPR-101 radiopharma program targeting the urokinase plasminogen activator receptor (uPAR). Based on these advances, Monopar has made the strategic decision to focus its resources on the assets and capabilities it has been building up in the radiopharma space. As such, the Company is winding down its non-radiopharma programs, including camsirubicin (and its Phase 1b clinical trial) as well as MNPR-202. The Company is targeting launching its second radiopharma clinical trial as early as the end of this year or the first quarter of 2025.
MNPR-101 for Radiopharmaceutical Use – First-in-Human Study with MNPR-101-Zr is Now Active
- Received clearance and recently initiated a first-in-human Phase 1 imaging and dosimetry clinical trial with novel radiopharmaceutical MNPR-101-Zr in advanced cancer patients. Further information about the MNPR-101-Zr trial is available at www.ClinicalTrials.gov under study identifier NCT06337084. This study is being led by internationally recognized radiopharmaceutical physician Prof. Rodney Hicks, founder of the Melbourne Theranostic Innovation Centre (MTIC).
- Optimized imaging and therapeutic MNPR-101 radiopharma programs, significantly increasing tumor uptake while minimizing uptake in healthy tissue (link). This work led to in vivo efficacy studies demonstrating near complete elimination of the tumor after a single injection of the MNPR-101 radiopharmaceutical agent.
- Imaged the biodistribution of a therapeutic radioisotope bound to MNPR-101, and demonstrated highly preferential tumor uptake in the tumor consistent with what is seen with the Zr-89 imaging radioisotope (link).
- Filed a provisional patent application to protect the recent advancements and optimizations Monopar has achieved with its MNPR-101 radiopharma programs.
- Announced that Monopar’s abstract on MNPR-101-Zr radiopharma program was selected for presentation at the Society of Nuclear Medicine and Molecular Imaging’s Annual Meeting on June 8-11, 2024.
- Monopar is targeting initiating a Phase 1 clinical study in advanced cancers with its therapeutic radiopharmaceutical MNPR-101-RIT as soon as the end of this year or early next year.
Results for the First Quarter Ended March 31, 2024, Compared to the First Quarter Ended March 31, 2023
Cash and Net Loss
Cash, cash equivalents and short-term investments as of March 31, 2024, were
Net loss for the first quarter of 2024 was
Research and Development (R&D) Expenses
R&D expenses for the first quarter of 2024 were
General and Administrative (G&A) Expenses
G&A expenses for the first quarter of 2024 were
About Monopar Therapeutics
Monopar Therapeutics is a clinical-stage radiopharmaceutical company focused on developing innovative treatments for cancer patients, including Phase 1-stage MNPR-101-Zr for imaging advanced cancers and late preclinical-stage MNPR-101 radio-immuno-therapeutic (RIT) for the treatment of advanced 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 and are not limited to: that Monopar is targeting initiating a Phase 1 clinical study in advanced cancers with its therapeutic radiopharmaceutical MNPR-101-RIT as soon as the end of this year or early next year; and that current funds will be sufficient for Monopar to continue operations at least through June 30, 2025, to continue to conduct and conclude its first-in-human clinical trial with Monopar’s MNPR-101-Zr radiopharmaceutical program, and to advance the preclinical MNPR-101-RIT therapeutic program into the clinic. The forward-looking statements involve risks and uncertainties including, but not limited to: that we may expend available funds sooner than anticipated or require additional funding due to change in circumstances or unanticipated events; that future preclinical or clinical data will not be as promising as the data to date; not enrolling sufficient patients in the MNPR-101-Zr Phase 1 clinical trial or at all; that MNPR-101-Zr and/or MNPR-101 conjugated to a therapeutic radioisotope may cause unexpected serious adverse effects or fail to image or be effective against the cancer tumors in humans; and the significant general risks and uncertainties surrounding the research, development, regulatory approval, and commercialization of imaging agents and therapeutics. 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:
Monopar Therapeutics Inc.
Investor Relations
Kim R. Tsuchimoto
Chief Financial Officer
kimtsu@monopartx.com
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FAQ
What clinical trial did Monopar Therapeutics initiate?
Monopar initiated the MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial in advanced cancer patients.
What radiopharmaceutical program is Monopar focusing on?
Monopar is concentrating its resources on the MNPR-101 radiopharma program targeting the urokinase plasminogen activator receptor (uPAR).
What were Monopar's net loss and funding status for Q1 2024?
Monopar reported a net loss of $1.6 million for Q1 2024. The company's funds are projected to last till at least June 30, 2025, but additional funding will be needed for future operations.
When did Monopar file a provisional patent application?
Monopar filed a provisional patent application to protect advancements in its MNPR-101 radiopharma programs.
Who is leading Monopar's Phase 1 imaging and dosimetry clinical trial?
The Phase 1 trial with MNPR-101-Zr is led by Prof. Rodney Hicks, an internationally recognized radiopharmaceutical physician.
