Initiated and Enrolling Patients into MNPR-101-Zr First-in-Human Phase 1 Radiopharma Clinical Trial MNPR-101 radio-immuno-therapeutic (RIT) Clinical Trial on Track to Initiate in Q4 2024 WILMETTE, Ill., Aug. 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 second quarter 2024 financial results and summarized recent developments. Recent Developments MNPR-101 for Radiopharmaceutical Use MNPR-101 is a uPAR-targeting antibody being developed as a precision radiopharmaceutical for both imaging and treatment of various cancers. MNPR-101-Zr is a cancer imaging agent radiolabeled with Zirconium-89, a positron emission tomography (PET) imaging isotope. Preclinical imaging studies have shown selective, high, and enduring tumor uptake across multiple uPAR-expressing cancers including pancreatic, colorectal, and triple negative breast cancers. An open-label Phase 1 imaging and dosimetry clinical trial of MNPR-101-Zr was recently initiated and is currently active and enrolling patients. An open-label Phase 1 clinical trial for Monopar’s therapeutic radiopharmaceutical MNPR-101-RIT is on track to initiate as early as Q4 2024. Preclinical in vivo studies of therapeutic radioisotopes, such as actinium-225 and lutetium-177, bound to MNPR-101 have shown near complete elimination of uPAR-expressing tumors after just a single injection. Monopar’s MNPR-101-RIT abstract was selected as a Top-Rated Oral Presentation at the European Association of Nuclear Medicine (EANM) 2024 Annual Congress that will be held in Hamburg, Germany in October 2024. A long-term supply agreement with NorthStar Medical Radioisotopes LLC was entered into under which NorthStar agreed to provide actinium-225 for Monopar’s development stage and potential future commercial stage programs. The NorthStar collaboration agreement was amended, with one primary impact being Monopar gaining full ownership and title to its lead MNPR-101 radiopharmaceutical platform. Reverse Stock Split On August 5, 2024, the stockholders approved the reverse stock split proposal at the Annual Meeting of Stockholders, which provided the Board of Directors with authority to effect a reverse split within the range of ratios approved by stockholders. Subsequently, the Board of Directors approved a reverse stock split of 1 for 5 shares of the Company's common stock in an attempt to regain compliance with the Nasdaq's continued listing requirements. The Company expects that the reverse stock split will become effective at 5:00 pm on Monday, August 12, 2024, and its common stock will begin trading on a split-adjusted basis at the open of trading on Tuesday, August 13, 2024. Results for the Second Quarter Ended June 30, 2024 Compared to the Second Quarter Ended June 30, 2023 Cash and Net Loss Cash, cash equivalents and short-term investments as of June 30, 2024, were $7.1 million. Monopar projects that its current funds will be sufficient to continue operations at least through August 31, 2025, including to continue to conduct and conclude our first-in-human clinical trial with our MNPR-101-Zr radiopharmaceutical imaging program and to advance our MNPR-101-RIT program into the clinic. We are in the process of winding down the camsirubicin Phase 1b clinical trial and the preclinical development of MNPR-202 due to focusing our finite financial resources on our radiopharmaceutical programs. We will require additional funding to further advance our clinical and preclinical programs, and we anticipate that we will seek to raise additional capital within the next 12 months to fund our future operations. Net loss for the second quarter of 2024 was $1.7 million, or $0.10 per share, compared to net loss of $2.2 million, or $0.16 per share, for the second quarter of 2023. Research and Development (R&D) Expenses R&D expenses for the quarter ended June 30, 2024 were $1,131,000, compared to $1,595,000 for the quarter ended June 30, 2023. This represents a decrease of $464,000 attributed to (1) a decrease of $636,000 in Validive clinical trial-related expenses due to the closure of the trial in March 2023, and (2) decrease in camsirubicin manufacturing costs of $138,000. These decreases were partially offset by a net increase of $310,000 due to other R&D expenses attributable to MNPR-101 for radiopharma use. General and Administrative (G&A) Expenses G&A expenses for the quarter ended June 30, 2024 were $658,000, compared to $733,000 for the quarter ended June 30, 2023. This represents a decrease of $75,000 primarily attributed to (1) a decrease in stock-based compensation to the board of directors of $64,000 as no equity awards were issued to the board of directors to-date in 2024, and (2) a net decrease in consulting, tax services and other G&A expenses of $11,000. Principal Effects of the Pending Reverse Stock Split The number of shares authorized remains at 40,000,000. After effectiveness of the anticipated reverse stock split, the unaudited proforma number of shares issued and outstanding will be approximately 3,520,366. The par value will remain unchanged at $0.001 per share. 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, as well as early development programs against solid 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 Monopar is on track to initiate a Phase 1 clinical study in advanced cancers with its therapeutic radiopharmaceutical MNPR-101-RIT as soon as Q4 2024; that NorthStar will provide actinium-225 for Monopar’s development stage and potential future commercial stage programs; that current funds will be sufficient for Monopar to continue operations at least through August 31, 2025, including 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; and that the Company expects that the reverse stock split at a ratio of 1 for 5 shares of common stock will become effective at 5:00 pm on Monday, August 12, 2024 and its common stock will begin trading on a split-adjusted basis at the open of trading on Tuesday, August 13, 2024. 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 preclinical data to date; not enrolling sufficient patients in the MNPR-101-Zr Phase 1 clinical trial; 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; the effects of general economic and market conditions on Monopar’s operations and ability to raise funding; whether the Company effects the reverse stock split as expected and whether the Company is able to regain compliance with Nasdaq’s requirements within required timeframes or at all; 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 Karthik Radhakrishnan Chief Financial Officerkarthik@monopartx.com Follow Monopar on social media for updates:Twitter: @MonoparTx LinkedIn: Monopar Therapeutics

临床1期财报引进/卖出

2024-06-25

·BioSpace

Monopar Announces MNPR-101-RIT Abstract Accepted as a Top-Rated Oral Presentation at EANM’24

WILMETTE, Ill., June 25, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company focused on developing innovative treatments for cancer patients, today announced that its abstract titled “Evaluation of Anti-uPAR Antibody as a Radiopharmaceutical for Imaging and Treatment of Solid Tumors” has been accepted as a “Top-Rated Oral Presentation” within the Scientific Program of the European Association of Nuclear Medicine (EANM) 2024 Annual Congress to be held on October 19-23, 2024 in Hamburg, Germany. Monopar’s abstract details its MNPR-101-RIT, a novel first-in-class radio-immuno-therapeutic program that targets cancers expressing the urokinase plasminogen activator receptor (uPAR), including triple-negative breast, colorectal, and pancreatic cancers. The Company’s preclinical data demonstrate compelling and durable anti-tumor benefits with MNPR-101 conjugated to therapeutic radioisotopes, including lutetium-177 (Lu-177) and actinium-225 (Ac-225). “We are honored by the recognition of our MNPR-101-RIT abstract at EANM’24,” said Chandler Robinson, MD, CEO of Monopar Therapeutics. “This selection underscores the potential of our uPAR-targeted therapy and the interest around uPAR as a potential new target for radiopharma treatment.” Monopar recently initiated its MNPR-101-Zr first-in-human Phase 1 imaging and dosimetry clinical trial in advanced cancer patients. Further information about this trial is available at under study identifier NCT06337084. About Monopar Therapeutics Inc. 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, as well as early development programs against solid cancers. For more information, visit: 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: the Company’s preclinical data demonstrating compelling and durable anti-tumor benefits with MNPR-101 conjugated to therapeutic radioisotopes, including lutetium-177 (Lu-177) and actinium-225 (Ac-225); and that the selection of Monopar’s abstract underscores the potential of its uPAR-targeted therapy and the interest around uPAR as a potential new target for radiopharma treatment. The forward-looking statements involve risks and uncertainties including, but not limited to: the recently initiated first-in-human Phase 1 imaging and dosimetry clinical trial in advanced cancer patients with MNPR-101-Zr may not yield satisfactory results, if at all; that future preclinical or clinical data will not be as promising as the data to date; not receiving regulatory clearance to proceed into human clinical trials for MNPR-101-RIT; that MNPR-101-Zr and/or MNPR-101-RIT may cause unexpected serious adverse effects 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 Follow Monopar on social media for updates: Twitter: @MonoparTx LinkedIn: Monopar Therapeutics

临床1期免疫疗法

2024-05-09

·GlobeNewswire-Health Care

Monopar Therapeutics Reports First Quarter 2024 Financial Results and Strategic Focus on its Radiopharma Pipeline

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 $1 billion to over $4 billion (BMS/RayzeBio, AstraZeneca/Fusion Pharma, Eli Lilly/POINT BioPharma, and Novartis/ Mariana Oncology). 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 $8.8 million. Monopar projects that its current funds will be sufficient to continue operations at least through June 30, 2025, to continue to conduct and conclude its first-in-human imaging and dosimetry clinical trial with MNPR-101-Zr, and to advance the preclinical MNPR-101-RIT therapeutic program into the clinic. Monopar will require additional funding to advance its preclinical and clinical programs beyond that, and anticipates seeking to raise additional capital within the next 12 months to fund its future operations. Net loss for the first quarter of 2024 was $1.6 million or $0.10 per share compared to net loss of $2.4 million or $0.19 per share for the first quarter of 2023. Research and Development (R&D) Expenses R&D expenses for the first quarter of 2024 were $966,000 compared to $1,653,000 for the first quarter of 2023. This decrease of $687,000 was primarily due to a decrease of $716,000 in Validive clinical trial-related expenses due to the closure of the trial in March 2023, partially offset by a net increase of $29,000 in other R&D expenses. General and Administrative (G&A) Expenses G&A expenses for the first quarter of 2024 were $757,000, compared to $872,000 for the first quarter of 2023. This represents a decrease of $115,000 primarily attributed to (1) a decrease in stock-based compensation to the non-employee directors of $70,000 as no equity awards were issued in the first quarter of 2024 compared to the first quarter of 2023, (2) a reduction of $62,000 in patent expenses related to the closure of the Validive trial, and (3) a reduction of stock-based compensation expenses to employees of $16,000 due to the full vesting of the 2020 grants in the fourth quarter of 2023, partially offset by a net increase in consulting, tax services and other G&A expenses of $33,000. 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 StatementsStatements 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 RelationsKim R. TsuchimotoChief Financial Officerkimtsu@monopartx.com Follow Monopar on social media for updates: Twitter: @MonoparTx LinkedIn: Monopar Therapeutics

临床1期财报并购

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