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Here are 1-2 brief analogies for Monopar Therapeutics (MNPR):

• Imagine a tiny, clinical-stage Bristol Myers Squibb, solely dedicated to developing novel cancer therapies.
• It's like a startup version of Genentech, focused on discovering new cancer drugs, but with its pipeline still deep in clinical trials.

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• Camsirubicin (MNPR-201): A novel topoisomerase II inhibitor being developed for the treatment of advanced soft tissue sarcoma (ASTS).
• MNPR-101 (uPAR-directed monoclonal antibody): A humanized monoclonal antibody designed to selectively target the urokinase plasminogen activator receptor (uPAR), overexpressed in many cancers and fibrotic diseases.
• MNPR-600 (Radioimmunotherapeutic Platform): A proprietary targeted alpha-particle radiopharmaceutical platform that leverages MNPR-101 for treating severe cancers.

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Monopar Therapeutics (MNPR) is a clinical-stage biopharmaceutical company focused on developing therapies for cancer and severe diseases.

As a clinical-stage company, Monopar Therapeutics is primarily engaged in research and development, conducting clinical trials for its investigational drug candidates. The company does not currently have any commercialized products for sale, and therefore does not have major customers in the traditional sense.

Monopar's financial reports, including its most recent 10-K filing (for the fiscal year ended December 31, 2023), explicitly state: "To date, we have not generated any revenue from the sale of any products." The company has also not reported significant collaboration or licensing revenue in recent years. Its operations are primarily funded through equity financing.

While biopharmaceutical companies at various stages may enter into licensing or collaboration agreements with other pharmaceutical companies (e.g., an historical agreement with Ipsen related to Validive), these typically involve upfront payments, milestone payments, and potential royalties rather than ongoing product sales to specific "customers." Monopar is currently focused on advancing its pipeline and is not generating revenue from such activities.

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• Siegfried AG (SFZN)
• Corden Pharma
• Polypeptide Group

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Chandler D. Robinson, MD MBA MSc, Co-Founder, Chief Executive Officer and Board Member

Dr. Robinson co-founded Monopar Therapeutics and has served as its CEO since December 2014. He co-founded and was CEO of Tactic Pharmaceuticals in 2010, leading it through a successful sale of its lead compound. He was also a co-founder and board member of Wilson Therapeutics, which was acquired by Alexion (now AstraZeneca) for $855 million in 2018. Dr. Robinson served as CEO of Gem Pharmaceuticals, LLC from 2012 until its drug development assets were acquired by Monopar in 2017, and as CEO of Jade Therapeutics Inc. from 2012 to 2015. His previous experience includes working at Onyx Pharmaceuticals, co-managing a healthcare clinic, and working at Bear Stearns investment bank.

Karthik Radhakrishnan, Chief Financial Officer, Principal Accounting Officer, and Principal Financial Officer

Mr. Radhakrishnan was appointed Monopar's Chief Financial Officer, Principal Accounting Officer, and Principal Financial Officer, effective July 1, 2024. He brings over 20 years of financial strategy, investment, and public company experience. Since January 2017, Mr. Radhakrishnan has served as President and founder of Titania Partners LLC, a management consulting firm focused on the life science sector. During this time, he served as CFO of Santalis Pharmaceuticals, Inc. and CEO of Asylia Therapeutics, Inc. He previously served as CFO of Opexa Therapeutics, Inc. and was a Vice President at ING Investment Management.

Christopher M. Starr, PhD, Co-Founder & Executive Chairman of the Board

Dr. Starr co-founded Monopar Therapeutics in 2014. He has helped bring six orphan product drugs to market. Dr. Starr co-founded and served as CEO of Raptor Pharmaceuticals from 2006 to 2014, overseeing the approval and commercialization of Procysbi®. Raptor Pharmaceuticals was subsequently sold to Horizon Pharma in 2016. He also co-founded BioMarin Pharmaceutical Inc. in 1997, where he served as Senior Vice President and Chief Scientific Officer until 2006.

Andrew P. Mazar, PhD, Co-Founder & Chief Scientific Officer

Dr. Mazar co-founded Monopar Therapeutics in December 2014 and serves as its Chief Scientific Officer. He is also listed as EVP, Research & Development.

Andrew J. Cittadine, Chief Operating Officer

Mr. Cittadine is an experienced healthcare executive and serial entrepreneur. He has a successful track record of identifying, founding, and building healthcare businesses from concept to commercialization, leading to their acquisition by Fortune Global 1000 firms.

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Key Risks to Monopar Therapeutics (MNPR)

1. Inability to Obtain Sufficient Future Funding: Monopar Therapeutics is a clinical-stage company with no commercialized products and, consequently, no revenue, leading to a history of financial losses. While the company has projected its current cash reserves to sustain operations into 2026, significant additional funding will be required to support the potential commercialization of its lead asset, ALXN1840, for Wilson Disease, and to continue the development of its radiopharmaceutical pipeline (MNPR-101-Zr, MNPR-101-Lu, and MNPR-101-Ac). The need for frequent capital raises can also lead to dilution of existing shareholder value.

2. Failure of Clinical Trials or Inability to Obtain Regulatory Approval: The success of Monopar's business is heavily dependent on the successful completion of its ongoing clinical trials and subsequent regulatory approvals for its drug candidates. There are inherent uncertainties in the clinical development process, including the risk of delays, outright failures, or results that are not sufficiently conclusive for regulatory agencies to grant marketing approval. A previous setback with its Validive program, which failed to meet efficacy endpoints in a Phase 2/3 study, underscores this risk.

3. Competition from Existing and Developing Therapies: Monopar's drug candidates face significant competition. For ALXN1840, its lead asset for Wilson Disease, the market includes existing generic therapies that could limit pricing power. Furthermore, there is competition from other pipeline candidates, such as Pfizer's gene therapy, VTX-801, which, if successful and brought to market, could potentially render ALXN1840 irrelevant. In the radiopharmaceutical space, Monopar competes with larger pharmaceutical companies and other firms developing targeted radiopharmaceuticals for cancer treatment.

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The increasing success and expanding indications of antibody-drug conjugates (ADCs) that utilize topoisomerase I inhibitor payloads represent an emerging threat. These targeted therapies, such as trastuzumab deruxtecan (Enhertu) and sacituzumab govitecan (Trodelvy), offer a more precise delivery of cytotoxic agents, potentially leading to improved efficacy and reduced systemic toxicity compared to standalone, systemically administered topoisomerase I inhibitors like Monopar's MNPR-101 and MNPR-202. This trend could challenge the market potential and perceived clinical value of non-targeted cytotoxic agents.

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1. Commercialization and Market Adoption of ALXN1840 for Wilson Disease: Monopar Therapeutics has assumed full responsibility for ALXN1840, a late-stage investigational drug for Wilson Disease, with a New Drug Application (NDA) submission planned for early 2026. Positive Phase 2 study results for ALXN1840, demonstrating rapid and sustained improvement in copper balance in Wilson disease patients, suggest a potentially significant advancement in treatment options. Analysts anticipate ALXN1840 to be a key revenue generator upon approval.

2. Advancement and Commercialization of MNPR-101 Radiopharmaceuticals in Oncology: The company is developing a pipeline of MNPR-101 radiopharmaceuticals targeting advanced solid tumors, including clinical-stage MNPR-101-Zr for imaging and MNPR-101-Lu for therapy, as well as the late-preclinical stage MNPR-101-Ac. As these programs progress through clinical trials and potentially achieve regulatory approvals, they will represent new product launches for various cancer indications, contributing to future revenue.

3. Strategic Collaborations and Partnerships: Monopar Therapeutics actively builds its drug development pipeline through in-house efforts and the licensing of promising late preclinical and clinical-stage therapeutics. Successful new collaborations or partnerships could provide upfront payments, milestone payments, and future royalty streams, thereby contributing to revenue. The company's strategy to develop MNPR-101 in combination with existing cancer therapies also highlights the potential for partnership-driven revenue.

4. Expansion of MNPR-101 Applications through Combination Therapies and New Radioisotopes: Monopar plans to develop MNPR-101 in combination with existing cancer therapies to potentially improve treatment outcomes. Additionally, the development of MNPR-101 conjugated with different radioisotopes, such as MNPR-101-Ac, indicates a broader application strategy within the oncology space, which could lead to expanded market opportunities and increased revenue streams.

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Share Issuance

• Monopar Therapeutics Inc. announced the pricing of a $135 million underwritten offering of common stock and pre-funded warrants on September 24, 2025.
• The number of outstanding shares increased by 80.26% in one year, leading to 7.20 million shares outstanding.
• A 1:5 reverse stock split was effected on August 13, 2024.

Capital Expenditures

• Capital expenditures have been reported as negligible ("n/a") for the company, indicating minimal spending in this category.