"Successful investing takes time, discipline, and patience. No matter how great the talent or effort, some things just take time", said Warren Buffett. The question now is - did you have the patience to hold on to stocks we highlighted and reap the gains? Cidara Therapeutics Inc. (CDTX) touched a 52-week high of $87.19 today, as it continues to progress with its accelerated development plan for CD388, a non-vaccine preventive treatment for seasonal influenza. The company will be pursuing a Biologics Licens ...

Core Viewpoint - Monopar Therapeutics Inc. has announced a registered offering of common stock and pre-funded warrants, aiming to raise approximately $100 million for general corporate purposes, including research and development [1][2][3]. Group 1: Offering Details - The offering consists of 1,034,433 shares of common stock priced at $67.67 per share and pre-funded warrants to purchase 960,542 shares at $67.669 each [1]. - The gross proceeds from the offering, net of anticipated stock repurchase, are expected to be around $100 million before underwriting discounts and expenses [2]. - The offering is anticipated to close on or about September 25, 2025, subject to customary closing conditions [3]. Group 2: Use of Proceeds - Monopar plans to allocate up to $35 million of the proceeds to repurchase shares from Tactic Pharma, LLC at a price of $63.6098 per share, which is equivalent to the offering price for investors [3]. Group 3: Management and Registration - Morgan Stanley, Leerink Partners, and Barclays are serving as lead book-running managers for the offering [4]. - The securities are being offered under a "shelf" registration statement filed with the SEC, with a prospectus supplement to be made available [5]. Group 4: Company Overview - Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments, including late-stage ALXN1840 for Wilson disease and various radiopharmaceutical programs for advanced cancers [7].

Core Insights - Monopar Therapeutics Inc. announced the publication of a peer-reviewed Letter to the Editor in the Journal of Hepatology, discussing the effects of ALXN1840 on copper balance in patients with Wilson disease [1][2] Group 1: Study Findings - The earlier conclusion from the Phase 2 ALXN1840-WD-204 study indicated that ALXN1840 did not promote copper excretion due to methodological limitations in the copper balance equation [2] - The new analysis shows that ALXN1840 statistically significantly improved copper balance, increasing copper excretion over the study duration [2] - Key findings include: - For the 15 mg/day treatment period, the mean daily difference in copper balance was -0.367 mg (p=0.005) - For the overall treatment period, the mean daily difference was -0.289 mg (p=0.023) - The cumulative mean change from baseline was -6.08 mg (95% CI: -10.18 mg to -1.98 mg) [5] Group 2: Company Overview - Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments for unmet medical needs, including late-stage ALXN1840 for Wilson disease [8] - The company also has radiopharmaceutical programs in various stages of development for imaging and treating advanced cancers [8]

Core Insights - Monopar Therapeutics Inc. announced the publication of a peer-reviewed Letter to the Editor in the Journal of Hepatology, discussing the effects of ALXN1840 on copper balance in patients with Wilson disease [1][2] Group 1: Study Findings - The earlier conclusion from the Phase 2 ALXN1840-WD-204 study indicated that ALXN1840 did not promote copper excretion due to methodological limitations in the copper balance equation [2] - By comparing pre- and post-treatment data, the analysis showed that ALXN1840 statistically significantly improved copper balance, leading to increased copper excretion [2] - Key findings from the study include: - For the 15 mg/day treatment period, the mean daily difference in copper balance was -0.367 mg (p=0.005) - For the overall treatment period, including dose changes, the mean daily difference was -0.289 mg (p=0.023) - The cumulative mean change from baseline was -6.08 mg (95% CI: -10.18 mg to -1.98 mg) [5] Group 2: Company Overview - Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments for unmet medical needs, including late-stage ALXN1840 for Wilson disease and various radiopharmaceutical programs [8]

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].

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]

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. reported a productive year in 2024, highlighted by the in-licensing of ALXN1840, initiation of two Phase 1 clinical trials, and a strengthened balance sheet with over $55 million in net proceeds from financings [2][3]. Recent Program Developments - The company plans to submit a New Drug Application (NDA) for ALXN1840 targeting Wilson disease in early 2026, following a successful Phase 3 clinical trial [3]. - ALXN1840 is a potent copper binder and mobilizer, addressing a rare genetic condition that leads to toxic copper accumulation [3]. - Monopar has executed a worldwide exclusive license for ALXN1840 with Alexion, which included a cash payment of $4 million and a 9.9% equity stake in Monopar [3]. Clinical Trials - MNPR-101 is currently enrolling in Phase 1 imaging and therapeutic oncology trials, targeting aggressive cancers through its imaging agent MNPR-101-Zr and therapeutic agent MNPR-101-Lu [4]. Recent Financings - In Q4 2024, Monopar raised over $55 million through various financings, including public offerings and private placements [5]. - The company dosed its first patient with MNPR-101-Lu in December 2024 and presented promising clinical data at the EANM 2024 Annual Congress [5]. Financial Results - As of December 31, 2024, Monopar reported cash and short-term investments of $60.2 million, sufficient to fund operations through at least December 31, 2026 [6]. - The net loss for Q4 2024 was $10.9 million, compared to $1.8 million in Q4 2023, while the annual net loss for 2024 was $15.6 million, up from $8.4 million in 2023 [7]. Research and Development Expenses - R&D expenses for Q4 2024 were $9.9 million, significantly higher than $1.0 million in Q4 2023, primarily due to the in-licensing of ALXN1840 [8]. - For the year ended December 31, 2024, R&D expenses totaled $13.0 million, compared to $5.6 million in 2023, reflecting increased investment in clinical programs [9]. General and Administrative Expenses - G&A expenses for Q4 2024 were $1.2 million, up from $0.9 million in Q4 2023, attributed to increases in personnel salaries and consulting fees [10]. - For the full year 2024, G&A expenses remained stable at $3.2 million compared to 2023 [11].