On March 28, 2024 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients, reported fourth quarter and full-year 2023 financial results and summarized recent developments (Press release, Monopar Therapeutics, MAR 28, 2024, View Source [SID1234641542]).

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Recent Developments

Novel MNPR-101 Radiopharmaceutical Program targeting uPAR – Phase 1 dosimetry clinical trial to commence in the coming weeks

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MNPR-101-Zr Phase 1 dosimetry clinical trial has Human Research Ethics Committee (HREC) clearance in Australia and is on track to initiate at the Melbourne Theranostic Innovation Centre (MTIC) within the next few weeks.
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Will enroll patients with advanced cancers, aiming for those most likely to have uPAR expression, which include a majority of all triple-negative breast, colorectal, and pancreatic cancers.

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Will utilize state-of-the-art positron emission tomography (PET) imaging to assess tumor uptake, normal organ biodistribution, and safety.

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Internationally recognized radiopharmaceutical physician, Professor Rodney Hicks, will be the lead investigator for the trial.

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Positive preclinical data support the potential of a MNPR-101 based radiopharmaceutical to provide a very meaningful clinical benefit to patients.

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In February 2024, Monopar shared preclinical biodistribution and efficacy data using imaging and therapeutic radioisotopes conjugated to MNPR-101. Imaging with MNPR-101-Zr in a pancreatic cancer human tumor xenograft mouse model showed high specificity and durable tumor uptake. With the therapeutic radioisotope actinium-225 (Ac-225) conjugated to MNPR-101, near complete elimination of tumor was achieved after a single injection in a triple negative breast human tumor xenograft mouse model.

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In March 2024, Monopar shared biodistribution data using the therapeutic radioisotope Lutetium-177 (Lu-177) conjugated to MNPR-101. The images show highly preferential uptake in tumor, helping explain the near complete elimination of tumors observed after a single injection of therapeutic radioisotopes bound to MNPR-101.

Camsirubicin – Phase 1b Dose-Escalation Trial, Currently enrolling the Fifth Dose-Level Cohort (650 mg/m2)

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Monopar is presently enrolling patients at the fifth dose level, which is over twice the highest dose reached in any prior camsirubicin clinical trial (650 mg/m2 versus 265 mg/m2).

Results for the Fourth Quarter and Year Ended December 31, 2023, Compared to the Fourth Quarter and Year Ended December 31, 2022

Cash and Net Loss

Cash, cash equivalents and short-term investments as of December 31, 2023, were $7.3 million. Monopar expects that its current funds, which include an additional $3.2 million from the net proceeds of its at-the-market facility in Q1 2024, will be sufficient for Monopar to continue operations at least through June 30, 2025, to conduct and conclude its first-in-human clinical trial with Monopar’s MNPR-101-Zr radiopharma program and continue the Company’s other pipeline programs.

Net loss for the fourth quarter of 2023 was $1.8 million or $0.12 per share compared to $2.9 million or $0.22 per share for the fourth quarter of 2022. Net loss for the year ended December 31, 2023 was $8.4 million or $0.61 per share compared to $10.5 million or $0.83 per share for the year ended December 31, 2022.

Research and Development (R&D) Expenses

R&D expenses for the fourth quarter of 2023 were $1.0 million compared to $2.1 million for the fourth quarter of 2022. This decrease of $1.1 million was primarily due to (1) a decrease of $0.9 million for Validive clinical trial expense, (2) a decrease of $0.2 million in camsirubicin manufacturing costs, and (3) a decrease of $0.1 million in R&D salaries, partially offset by an increase of $0.1 million in MNPR-101 radiopharmaceutical program development activities.

R&D expenses for the year ended December 31, 2023 were $5.6 million compared to $7.6 million for the year ended December 31, 2022. This decrease of $2.0 million was primarily due to (1) a decrease of $1.4 million for Validive clinical trial and manufacturing costs, (2) a decrease of $0.9 million in camsirubicin clinical trial and manufacturing costs, (3) a decrease of $0.1 million in R&D salaries, partially offset by an increase of $0.4 million in MNPR-101 radiopharma activity.

General and Administrative (G&A) Expenses

G&A expenses for the fourth quarter of 2023 were $0.9 million, compared to $0.8 million for the fourth quarter of 2022. This increase of $0.1 million was primarily due to an increase in G&A personnel expenses.

G&A expenses for the year ended December 31, 2023 were $3.2 million, compared to $2.9 million for the year ended December 31, 2022. This increase of $0.3 million was primarily due to an increase in G&A personnel expenses.