Core Viewpoint - Monopar Therapeutics Inc. reported its third quarter 2025 financial results, highlighting advancements in its drug candidates and recent financing activities, indicating a strong position for future growth and regulatory submissions [1]. Recent Developments - ALXN1840 for Wilson Disease: New data presented at the 150th American Neurological Association Annual Meeting demonstrated long-term neurological efficacy and safety of ALXN1840, emphasizing its potential to positively impact both neurological and hepatic manifestations of Wilson disease [2][3]. - MNPR-101 for Radiopharmaceutical Use: The FDA cleared the IND application for MNPR-101-Lu, which aims to treat advanced or metastatic solid tumors, utilizing proprietary linker technology to enhance therapeutic efficacy [5]. Recent Financing Capital Raise and Share Repurchase - On September 23, 2025, Monopar priced a public offering of 1,034,433 shares at $67.67 per share, raising approximately $126.9 million in net proceeds [6]. - Following the offering, the company repurchased 550,229 shares from Tactic Pharma for $35 million, resulting in net proceeds of approximately $91.9 million after the share repurchase [7]. Financial Results for the Third Quarter Ended September 30, 2025 - Cash, cash equivalents, and investments totaled $143.7 million, sufficient to support operations through at least December 31, 2027, while advancing multiple clinical trials and R&D projects [9]. - The net loss for Q3 2025 was $3.4 million, or $0.48 per share, compared to a net loss of $1.3 million, or $0.37 per share, in Q3 2024 [10]. - R&D expenses increased to $2.59 million, primarily due to higher manufacturing activities and personnel costs [11]. - G&A expenses rose to $1.50 million, driven by increased board compensation and personnel expenses [12]. - Interest income increased by $556,129, attributed to higher bank balances and interest earned on U.S. Treasury securities [13]. Company Overview - Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments for unmet medical needs, with key programs including ALXN1840 for Wilson disease and various radiopharmaceutical candidates [14].

Core Insights - Monopar Therapeutics Inc. has been identified as a promising investment opportunity, with Raymond James raising its price target from $80 to $142 while maintaining a Strong Buy rating [1][3] Financial Performance - In Q2 2025, Monopar reported a net loss of $2.5 million ($0.35 per share), an increase from a net loss of $1.7 million ($0.49 per share) in Q2 2024 [2] - The company has cash, cash equivalents, and investments totaling $53.3 million, which is expected to support operations through December 31, 2026 [2] Development Pipeline - The increased price target reflects confidence in the company's ability to execute its anticipated timeline, including filing an NDA for ALXN1840, completing its Phase 1 imaging/dosimetry trial for MNPR-101-Zr, continuing its Phase 1a therapeutic trial for MNPR-101-Lu, and advancing the preclinical MNPR-101-Ac program into the clinic [3]

Core Insights - Monopar Therapeutics Inc. announced that its abstract on the Phase 2 ALXN1840-WD-204 copper balance study has been selected for an oral presentation at the AASLD – The Liver Meeting 2025, scheduled for November 7-11, 2025 in Washington, D.C. [1] Company Overview - Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments for unmet medical needs, with late-stage ALXN1840 for Wilson disease and various radiopharmaceutical programs [3] - The company is also working on Phase 1-stage MNPR-101-Zr for imaging advanced cancers, and Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac225 for treating advanced cancers [3] Presentation Details - The abstract for the oral presentation is available on the conference website, with materials to be accessible on Monopar's website on November 9, 2025 [2] - The presentation will take place on November 9, 2025, from 9:00-9:15 am EST, featuring the presenting author Aftab Ala, MBBS, M.D., FRCP, Ph.D. [5]

Market Outlook - Ryan Detrick, chief market strategist at Carson Group, anticipates a strong end-of-year rally despite historically weak periods in late September and early October [1] - The market has experienced five consecutive months of gains, which historically leads to an average decline in October, suggesting a potential break for investors [1] - Q4 typically shows a median return of nearly 6% when the market has been up for five months prior, indicating bullish sentiment [1] Investment Strategy - Detrick expressed a desire for a mild correction of 4-6%, viewing it as a healthy market adjustment [2] - Current market indicators include low put-to-call ratios and a significant inflow of $58 billion into US equity funds, the highest this year [2] - Anticipated volatility around Jewish holidays and early October may present buying opportunities, driven by strong earnings and consumer performance [2] Company Highlights Monopar Therapeutics Inc. (NASDAQ:MNPR) - Achieved a 3-month performance of 100.82% as of October 10, with an average upside potential of 20.70% [7][8] - Raymond James raised the price target from $80 to $142, maintaining a Strong Buy rating, indicating confidence in the company's future performance [8] - Reported a net loss of $2.5 million for Q2 2025, an increase from a net loss of $1.7 million in Q2 2024, with cash reserves of $53.3 million to support operations through December 2026 [9] Mesoblast Limited (NASDAQ:MESO) - Recorded a 3-month performance of 64.01% as of October 10, with an average upside potential of 56.16% [11] - The company received a permanent J-Code for its product Ryoncil, enhancing billing and reimbursement pathways, which is a significant commercial milestone [12] - Ryoncil is the first FDA-approved mesenchymal stromal cell product for pediatric patients with steroid-refractory acute graft-versus-host disease, expanding its market potential [13][14]

Company Highlights - Cidara Therapeutics Inc. (CDTX) reached a 52-week high of $87.19 as it advances its development plan for CD388, a non-vaccine preventive treatment for seasonal influenza, with enrollment in a Phase 3 study expected to start by September 2025 targeting 6,000 participants [1] - Maze Therapeutics Inc. (MAZE) saw its stock rise to a 52-week high of $27.09 following positive Phase 1 clinical results for MZE782, an oral therapy for Phenylketonuria and chronic kidney disease, with plans to enter Phase 2 studies in 2026 [3][4] - Medpace Holdings Inc. (MEDP) is set to report Q3 2025 financial results on October 22, 2025, and has raised its full-year guidance twice, indicating strong operational momentum, with the stock hitting a 52-week high of $506.55 [5][6] - Monopar Therapeutics Inc. (MNPR) rebounded from potential Nasdaq delisting to a 52-week high of $73.75, planning to seek approval for ALXN1840 for Wilson disease in early 2026, supported by long-term clinical data [7][8] - Prenetics Global Limited (PRE) projects 2025 revenue between $85 million and $100 million, a significant increase from $30.6 million in 2024, with its new wellness brand IM8 Health on track for $100 million in annual recurring revenue [9][10] - Protagonist Therapeutics Inc. (PTGX) is nearing a major milestone with Icotrokinra for psoriasis, having submitted a regulatory application to the FDA and EMA in July 2025, with the stock reaching a 52-week high of $66.70 [11][12] - uniQure N.V. (QURE) announced positive results from its Phase I/II study of AMT-130 for Huntington's disease, planning to submit a Biologics License Application in Q1 2026, with the stock soaring over 200% to a 52-week high of $51.21 [13][14] - Rezolute Inc. (RZLT) surged to a 52-week high of $9.02 ahead of topline results from its pivotal Phase III trial for hypoglycemia treatment, expected in December [15][16] - United Therapeutics Corp. (UTHR) reached a 52-week high of $442.01 as anticipation builds for data from the TETON-2 study of nebulized Tyvaso in idiopathic pulmonary fibrosis, with positive results reported earlier [17][18]

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]