Monopar Therapeutics Files 8-K: Acquisition, Debt, and Equity Sales

TL;DR

Monopar Therapeutics filed an 8-K detailing an acquisition, new debt, and equity sales. Big moves happening!

AI Summary

On October 23, 2024, Monopar Therapeutics Inc. entered into a material definitive agreement related to the completion of an acquisition. The company also disclosed the creation of a direct financial obligation and reported unregistered sales of equity securities. This filing indicates significant corporate activity and potential financial restructuring.

Why It Matters

This 8-K filing signals substantial corporate actions for Monopar Therapeutics, including an acquisition, new financial obligations, and equity sales, which could impact its financial standing and future operations.

Risk Assessment

Risk Level: medium — The filing indicates significant corporate events including an acquisition, new financial obligations, and equity sales, which introduce financial and operational risks.

Key Players & Entities

• Monopar Therapeutics Inc. (company) — Registrant
• October 23, 2024 (date) — Earliest event reported
• Delaware (jurisdiction) — State of incorporation
• 1000 Skokie Blvd. , Suite 350 , Wilmette , IL (address) — Business and mailing address

FAQ

Key Financial Figures

• $0.001 — nge on which registered Common Stock, $0.001 par value MNPR The Nasdaq Stock Mar
• $4.0 m — reed to make an upfront cash payment of $4.0 million, which shall be payable in two in
• $1.0 million — ayable in two installments, including a $1.0 million cash payment at the time of signing and
• $3.0 million — sh payment at the time of signing and a $3.0 million cash payment within ninety (90) days. A
• $25.0 million — uances of Common Stock through the next $25.0 million of common equity capital raised by the
• $94.0 m — n aggregate milestone payments of up to $94.0 million, including regulatory approval an
• $4.0 million — gram. As a result, the costs beyond the $4.0 million due at signing and within ninety (90) d
• $6.0 million — and cash equivalents were approximately $6.0 million. Although this would allow us to make a

Filing Documents

• mnpr20241021_8k.htm (8-K) — 60KB
• ex_735036.htm (EX-10.1) — 417KB
• ex_735037.htm (EX-10.2) — 104KB
• ex_735003.htm (EX-99.1) — 16KB
• monologo.jpg (GRAPHIC) — 4KB
• 0001437749-24-031957.txt ( ) — 852KB
• mnpr-20241023.xsd (EX-101.SCH) — 3KB
• mnpr-20241023_def.xml (EX-101.DEF) — 12KB
• mnpr-20241023_lab.xml (EX-101.LAB) — 16KB
• mnpr-20241023_pre.xml (EX-101.PRE) — 12KB
• mnpr20241021_8k_htm.xml (XML) — 3KB

01 Entry into a Material Definitive Agreement

Item 1.01 Entry into a Material Definitive Agreement. On October 23, 2024, Monopar Therapeutics Inc. (the "Company" or "Monopar") executed a License Agreement effective October 23, 2024 (the "License Agreement") with Alexion Pharmaceuticals, Inc. ("Alexion, AstraZeneca Rare Disease" or "Alexion"), pursuant to which Alexion, AstraZeneca Rare Disease granted the Company an exclusive worldwide license for the development and commercialization of ALXN-1840, a drug candidate for Wilson disease that has progressed through a Phase 3 clinical trial that met its primary endpoint (the "Licensed Product"). As initial upfront consideration for the License Agreement, Alexion will receive 387,329 shares (the "Initial Shares") of the Company's common stock (the "Common Stock") (representing a 9.9% beneficial ownership interest in the Company upon issuance) and the Company has agreed to make an upfront cash payment of $4.0 million, which shall be payable in two installments, including a $1.0 million cash payment at the time of signing and a $3.0 million cash payment within ninety (90) days. Additionally, Alexion is eligible to receive milestones and royalties, as further described below. The Initial Shares will be issued pursuant to a separate Common Stock Investment Agreement, also dated October 23, 2024, between the Company and Alexion (the "Equity Agreement"). Pursuant to the Equity Agreement, the Company agreed to anti-dilution provisions that entitle Alexion to additional shares (together with the Initial Shares, the "Shares") of Common Stock so that the total number of Shares issued thereunder continue to represent 9.9% of outstanding shares after any subsequent issuances of Common Stock through the next $25.0 million of common equity capital raised by the Company, subject to a maximum of 705,015 Shares (inclusive of the Initial Shares) unless the Company obtains stockholder approval. The Equity Agreement also entitles Alexion to customary registration rights and the Comp

01 Completion of Acquisition or Disposition of Assets

Item 2.01 Completion of Acquisition or Disposition of Assets. The information set forth in Item 1.01 above is incorporated by reference into this Item 2.01.

03 Creation of a Direct Financial Obligation

Item 2.03 Creation of a Direct Financial Obligation. The information set forth in Item 1.01 above is incorporated by reference into this Item 2.03.

02 Unregistered Sales of Equity Securities

Item 3.02 Unregistered Sales of Equity Securities. The information set forth in Item 1.01 above is incorporated by reference into this Item 3.02. The Shares are being sold and issued without registration under the Securities Act of 1933, as amended (the "Securities Act"), in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act as a transaction not involving a public offering.

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On October 24, 2024, the Company issued a press release announcing it entered into a license agreement with Alexion, AstraZeneca Rare Disease. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.

01 Other Events

Item 8.01 Other Events. Wilson disease is a rare and progressive genetic condition in which the body's pathway for removing excess copper is compromised. It affects one in 30,000 live births in the US. Over time this results in the build-up of toxic copper levels in the liver, brain, and other organs, leading to damage that greatly impacts a patient's life. Patients can develop a wide range of symptoms, including liver disease and/or psychiatric or neurological symptoms, such as personality changes, tremors and difficulty walking, swallowing or talking. In some cases, the damage and loss of function may be irreversible. ALXN-1840 (bis-choline tetrathiomolybdate) is an investigational once-daily, oral medicine in development for the treatment of Wilson disease. This novel molecule is designed to selectively and tightly bind and remove copper from the body's tissues and blood. ALXN-1840 has been granted Orphan Drug Designation in the United States and orphan designation in the European Union for Wilson disease. A pivotal Phase 3 trial with ALXN-1840 has been completed, which met its primary endpoint. The primary endpoint assessed copper mobilization over 48 weeks, defined as daily mean AUEC (Area Under the Effect Curve) for dNCC (directly measured non-ceruloplasmin-bound copper). In the trial, 214 patients were enrolled, and the trial was randomized, rater-blinded, and multi-centered, designed to evaluate the efficacy and safety of ALXN-1840 versus standard-of-care (SoC) in patients with Wilson disease aged 12 years and older. In the trial, people taking ALXN-1840 experienced rapid copper mobilization, with a response at four weeks and sustained through the 48 weeks. The primary endpoint demonstrated three-times greater copper mobilization from tissues compared to the SoC arm (Least Square Mean Difference [LSM Diff] 2.18 mol/L; p< 0.0001), including in patients who had been treated previously for an average of 10 years. Alexion ended up terminating the ALXN-1840

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits Exhibit No. Description 10.1* License Agreement between Alexion and Monopar dated October 23, 2024 10.2 Common Stock Investment Agreement between Alexion and Monopar dated as of October 23, 2024 99.1 Press Release Dated October 24, 2024 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) * Portions of this exhibit (indicated by asterisks) have been redacted in compliance with Regulation S-K Item 601(b)(10)(iv).

Forward-Looking Statements

Forward-Looking Statements This 8-K, and any documents we incorporate by reference, contain certain forward-looking statements that involve substantial risks and uncertainties. All statements contained in this Form 8-K and any documents we incorporate by reference, other than statements of historical facts, are forward-looking statements including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. The words "anticipate", "believe", "estimate", "expect", "intend", "may", "plan", "predict", "project", "target", "potential", "will", "would", "could", "should", "continue" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among other things, statements about: our near term ability to raise sufficient funds in order for us to support continued clinical, regulatory and commercial development of our programs and to make contractual upfront and future milestone payments, as well as our ability to further raise additional funds in the future to support any existing or future product candidate programs through completion of clinical trials, the approval processes and, if applicable, commercialization our ability to raise funds on acceptable terms our ability to find a suitable pharmaceutical partner or partners to further our development efforts, under acceptable financial terms risks and uncertainties associated with our or any development partners' research and development activities, including preclinical

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