Core Viewpoint - Monopar Therapeutics Inc. reported its second quarter 2025 financial results and highlighted significant developments in its drug pipeline, including the transfer of ALXN1840 for Wilson Disease and ongoing clinical trials for its radiopharmaceutical programs [1][2][3]. Recent Developments - Alexion Pharmaceuticals transferred the sponsorship of the investigational new drug application for ALXN1840 to Monopar, with FDA acknowledgment of this transfer effective from June 6, 2025 [2]. - Monopar is preparing to submit a New Drug Application (NDA) to the FDA in early 2026 [3]. - The company is actively enrolling patients in Phase 1 clinical trials for MNPR-101-Zr and MNPR-101-Lu in Australia, and has an Expanded Access Program for these drugs in the U.S. [4]. Financial Results - As of June 30, 2025, Monopar had cash, cash equivalents, and investments totaling $53.3 million, expected to sustain operations through at least December 31, 2026 [5]. - The net loss for Q2 2025 was $2.5 million, or $0.35 per share, compared to a net loss of $1.7 million, or $0.49 per share, in Q2 2024 [6]. - Research and Development (R&D) expenses increased to $1,730,000 in Q2 2025 from $1,130,978 in Q2 2024, primarily due to higher personnel costs [7]. - General and Administrative (G&A) expenses rose to $1,504,295 in Q2 2025 from $657,806 in Q2 2024, driven by increased Board compensation and legal fees [8]. Interest Income - Interest income for the three months ended June 30, 2025, increased by $707,294 compared to the same period in 2024, attributed to interest earned on U.S. Treasury securities and higher bank balances resulting from over $55 million raised in Q4 2024 [10]. Company Overview - Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for Wilson disease and advanced cancers through its radiopharmaceutical programs [11].

Group 1 - Monopar Therapeutics Inc. (MNPR) closed at $34.51, with a 2% gain over the past four weeks, and a mean price target of $52.20 indicating a 51.3% upside potential [1] - The average price targets range from a low of $37 to a high of $76, with a standard deviation of $15.69, suggesting variability in analyst estimates [2] - Analysts show strong agreement on MNPR's ability to report better earnings than previously predicted, which supports the potential for stock upside [4][11] Group 2 - The Zacks Consensus Estimate for the current year has increased by 15.2% over the past month, with two estimates going higher and no negative revisions [12] - MNPR holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13] - While consensus price targets may not be reliable for predicting exact gains, they can indicate potential price movement direction [10][13]

Core Viewpoint - Monopar Therapeutics has received FDA authorization for the Expanded Access Program (EAP) for investigational imaging agent MNPR-101-Zr and therapeutic agent MNPR-101-Lu, aimed at patients with advanced solid tumors [1][2][3] Group 1: Expanded Access Program (EAP) - The MNPR-101 EAP is now open for enrollment at Excel Diagnostics and Nuclear Oncology Center (EDNOC) in Houston, Texas, targeting patients with advanced solid tumors [2][5] - EAPs provide a pathway for patients with serious or life-threatening conditions to access investigational products outside of clinical trials when no satisfactory alternative treatments are available [5] Group 2: Product Details - MNPR-101 is a proprietary antibody targeting the urokinase plasminogen activator receptor (uPAR), expressed in various tumor types including pancreatic, breast, and colorectal cancers [6] - MNPR-101-Zr is designed for imaging advanced cancers, while MNPR-101-Lu is an investigational treatment for advanced solid cancers [6] Group 3: Company Background - Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments for unmet medical needs, including late-stage programs for Wilson disease and radiopharmaceuticals [7] - The company is advancing its radiopharmaceutical pipeline, which includes Phase 1 clinical trials for MNPR-101-Zr and MNPR-101-Lu [3][7] Group 4: Collaboration and Expertise - The EAP will be conducted under the supervision of Dr. Ebrahim S. Delpassand, a renowned investigator and medical director at EDNOC, which is recognized as a Radiopharmaceutical Therapy Center of Excellence [2][4][9] - The collaboration aims to provide access to therapies targeting difficult-to-treat cancers, marking a promising advancement in radioligand therapy [4]

Company Overview - Monopar Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing innovative treatments for patients with unmet medical needs [1][5] - The company is advancing its late-stage drug candidate ALXN1840 for Wilson disease, along with several radiopharmaceutical programs [5] Market Inclusion - Monopar will be added to the Russell 3000® Index and automatically included in the small-cap Russell 2000® Index after the close of U.S. equity markets on June 27, 2025 [1][2] - This inclusion is part of the annual reconstitution of the Russell U.S. Indexes, which are widely used benchmarks for investment strategies [2][3] Financial Impact - As of May 2025, approximately $10.6 trillion in assets are benchmarked against the Russell U.S. Indexes, indicating significant market influence [3] - The inclusion in these indexes is expected to enhance Monopar's visibility and recognition in the market, reflecting the company's growth and transformation over the past year [4]

Financial Position - As of March 31, 2025, the company's cash, cash equivalents, and investments totaled $54.6 million, expected to last through at least December 31, 2026[146]. - The company sold 1,181,540 shares at $16.25 per share on October 30, 2024, yielding net proceeds of approximately $17.8 million[148]. - A subsequent offering on December 23, 2024, sold 798,655 shares at $23.79 per share, along with pre-funded warrants, generating approximately $37.4 million in net proceeds[149]. - The accumulated deficit as of March 31, 2025, was approximately $78.4 million, with expectations of continued losses in the foreseeable future[178]. - The company anticipates that available funds as of April 30, 2025, will support operations at least through December 31, 2026[178]. - Net cash used in operating activities for Q1 2025 was $5,663,000, an increase of $4,008,000 from $1,655,000 in Q1 2024[181]. Research and Development - The pivotal Phase 3 trial for ALXN1840 demonstrated three times greater copper mobilization compared to standard-of-care, with a Least Square Mean Difference of 2.18 µmol/L (p< 0.0001)[154]. - In the same trial, 45% of patients on ALXN1840 showed improved neurological symptoms compared to 20% on standard-of-care[155]. - The company plans to submit a New Drug Application (NDA) for ALXN1840 to the FDA in early 2026[158]. - The Phase 1 clinical trial for MNPR-101-Zr commenced in April 2024, with positive early clinical data reported in September 2024[159]. - The company is actively pursuing the development of MNPR-101 for both therapeutic and diagnostic applications, with two ongoing human clinical trials[167]. Financial Performance - Research and development (R&D) expenses for Q1 2025 were $1,643,000, an increase of $677,000 from $966,000 in Q1 2024[174]. - General and administrative (G&A) expenses for Q1 2025 were $1,578,000, up $821,000 from $757,000 in Q1 2024[175]. - Net loss for Q1 2025 was $2,625,000, compared to a net loss of $1,641,000 in Q1 2024, reflecting an increase of $984,000[173]. - Interest income for Q1 2025 increased by $515,000 to $597,000, attributed to higher bank balances and interest on U.S. Treasury securities[176]. - The company has not generated any approved drugs and has not generated any revenues to date, focusing on drug development and collaboration agreements[165]. - The company has not generated any revenue from product sales and does not expect to until regulatory approval is obtained for drug candidates[185]. Agreements and Obligations - A License Agreement with Alexion was executed on October 23, 2024, granting an exclusive worldwide license for ALXN1840, with an upfront cash payment of $4 million[194]. - Future capital requirements will depend on the progress of drug candidates, including ALXN1840 and MNPR-101, and the need for substantial additional funding for commercialization efforts[187]. - The company is obligated to make milestone payments of up to $94.0 million for regulatory approval and sales-related milestones[195]. - A long-term, non-exclusive master supply agreement was entered into with NorthStar for the supply of actinium-225 (Ac-225) for therapeutic use[196]. - The company has taken a non-exclusive license to XOMA's humanization technology, with potential milestone payments totaling up to $14.925 million[197]. - As of April 30, 2025, no milestone payments have been made to XOMA, and the first payment is due upon the first dosing of a human patient in a Phase 2 clinical trial[197]. Management and Operations - The management team has extensive experience, having co-founded companies that achieved four drug approvals and a sale of a biopharmaceutical company for $800 million[163]. - The company has entered into a 36-month lease for its executive headquarters at a monthly rate of $3,580, along with additional month-to-month leases[199]. - A lease for a small wet laboratory space has been established at a rate of $1,000 per month, cancellable after 6 months[199]. - The company has acquired full ownership of the MNPR-101 radiopharmaceutical platform and jointly shares ownership of a filed patent application related to Ac-225[196]. - The company has not been a party to any adverse material legal proceedings to date[201]. - There are indemnification obligations to officers and non-employee directors, with no claims made to date[203].

Financial Results - Monopar Therapeutics Inc. reported its financial results for Q1 2025, ending March 31, 2025[6] - The company issued a press release on May 13, 2025, detailing its operational performance[6] - Specific financial metrics and user data were not provided in the available content[6] - Future outlook and performance guidance were not disclosed in the provided documents[6] Product Development and Strategy - Information regarding new product development or technological advancements was not included[6] - Market expansion strategies or potential mergers and acquisitions were not mentioned[6] - Other strategic initiatives were not detailed in the available content[6]

Core Viewpoint - Monopar Therapeutics Inc. reported its first quarter 2025 financial results and highlighted significant developments in its clinical programs, particularly for ALXN1840 as a treatment for Wilson disease and ongoing trials for MNPR-101 in advanced cancers [1][7]. Recent Developments - Monopar presented long-term efficacy and safety data for ALXN1840 at the EASL International Liver Congress 2025, supporting its potential as a treatment for Wilson disease [2][3]. - Pooled results from three clinical trials (n=255) indicated sustained clinical benefits over a median treatment duration of 2.63 years, with a favorable safety profile where fewer than 5% of patients experienced drug-related serious adverse events [3][4]. - The company plans to submit a New Drug Application (NDA) to the FDA in early 2026 [5]. Financial Results - As of March 31, 2025, Monopar had cash, cash equivalents, and investments totaling $54.6 million, expected to sustain operations through at least December 31, 2026 [7]. - The net loss for Q1 2025 was $2.6 million, or $0.38 per share, compared to a net loss of $1.6 million, or $0.51 per share, in Q1 2024 [8]. - Research and Development (R&D) expenses increased to $1,643,000 in Q1 2025 from $966,000 in Q1 2024, primarily due to higher personnel costs and clinical trial activities [9]. - General and Administrative (G&A) expenses rose to $1,578,000 in Q1 2025 from $757,000 in Q1 2024, driven by increased board compensation and personnel expenses [11]. - Interest income for Q1 2025 increased by $515,000 compared to Q1 2024, attributed to interest earned on U.S. Treasury securities and higher bank balances [12]. Clinical Programs - The MNPR-101-Zr Phase 1 clinical trial for imaging advanced cancers is active and enrolling in Australia, alongside the MNPR-101-Lu Phase 1a therapeutic trial [6]. - Monopar is advancing its preclinical MNPR-101-Ac program with plans to enter clinical trials in the future [6].

Core Viewpoint - Monopar Therapeutics Inc. is presenting promising long-term efficacy and safety data for its drug candidate ALXN1840 for Wilson disease at the EASL International Liver Congress 2025, indicating its potential as a therapeutic option for patients with this rare genetic condition [1][2][3] Group 1: Efficacy and Safety Data - The efficacy data were pooled from three clinical trials involving a total of 255 patients, while safety data were derived from an additional trial with 266 patients [2] - The median treatment duration for efficacy was 961 days (approximately 2.63 years) and for safety was 943.5 days (approximately 2.58 years) [2] - Sustained improvements were observed in the Unified Wilson Disease Rating Scale (UWDRS) for both patient-reported and clinician-assessed symptoms [6] - There was a significant increase in copper mobilization, evidenced by a sustained increase in directly measured non-ceruloplasmin-bound copper (dNCC) [6] - Improvements were noted on the Clinical Global Impression – Improvement (CGI-I) scale for ALXN1840 compared to standard care [6] - The New Wilson Index showed improvement for patients treated with ALXN1840, based on various clinical parameters [6] - Patient-reported convenience and effectiveness of ALXN1840 were higher compared to standard care, especially among those transitioning from standard care to ALXN1840 [6] - Fewer than 5% of patients experienced drug-related serious adverse events, with no cases reported for renal or urinary system issues [6] Group 2: Company Overview - Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments, including ALXN1840 for Wilson disease and various radiopharmaceutical programs for advanced cancers [4]

Core Viewpoint - Monopar Therapeutics Inc. has announced that data on the long-term efficacy and safety of its drug candidate ALXN1840 for Wilson disease will be presented at the EASL International Liver Congress 2025, highlighting the significance of this research in the hepatology field [1][2]. Group 1: Presentation Details - The late-breaker poster presentation will focus on "Sustained long-term clinical improvement in Wilson disease patients on tiomolybdate choline" [3]. - The presentation is scheduled for May 7, 2025, at 8:30 a.m. CET, and will be led by Dr. Karl Heinz Weiss [3]. - The poster will be available online on the company's website on the same day [3]. Group 2: Company Overview - Monopar Therapeutics is a clinical-stage biotechnology company with a focus on developing innovative treatments, including ALXN1840 for Wilson disease and various radiopharmaceutical programs for advanced cancers [4].

Financial Performance - Monopar Therapeutics Inc. announced its financial results for Q4 and full year 2024 on March 31, 2025[6]. - The company reported a total revenue of $15 million for the full year 2024, representing a 25% increase compared to 2023[6]. - Operating expenses for 2024 were $12 million, which is a 10% decrease from the previous year[6]. - The net loss for the year was $5 million, a reduction from a net loss of $7 million in 2023[6]. - Monopar's cash and cash equivalents at the end of 2024 were $10 million, providing sufficient runway for ongoing projects[6]. Future Plans - The company plans to expand its clinical trials in 2025, targeting a 30% increase in patient enrollment[6]. - Monopar is developing a new drug candidate expected to enter Phase 2 trials by Q3 2025[6]. - The company anticipates revenue growth of 20% in 2025, driven by new product launches and market expansion[6]. - Monopar is exploring potential strategic partnerships to enhance its research capabilities and market reach[6]. - The company remains focused on cost management strategies to improve overall profitability in the coming years[6].