Monopar Therapeutics
For the period ended Sep 30, 2025. Filed Nov 13, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 13, 2025
MNPR$71.42+6.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-12.
0001437749-25-026042
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-13.
0001437749-25-034617
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 87 previous paragraphs and 93 current paragraphs.
66 unchanged; 18 reworded; 7 added; 3 removed; 0 previous and 2 current paragraphs rearranged.
Tables are not compared: 9 previous and 10 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (7)
Current report
On September 23, 2025, pursuant to an underwriting agreement with Morgan Stanley & Co. LLC, Leerink Partners LLC, and Barclays Capital Inc., we sold 1,034,433 shares of our common stock at $67.67 per share in a public offering and pre-funded warrants to purchase 960,542 shares of our common stock at $67.669 per pre-funded warrant, reflecting the $0.001 exercise price. The net proceeds of the shares and pre-funded warrants sold were approximately $126.9 million after underwriting discounts and commissions but before offering expenses. On September 24, 2025, pursuant to a share purchase agreement with Tactic Pharma, an existing significant stockholder that held approximately 13.4% of our common stock prior to this offering, we used $35 million of the Offering proceeds to repurchase 500,229 shares of our common stock from Tactic Pharma at $63.6098 per share, which equals the public offering price per share less underwriting discounts and commissions. After giving effect to the repurchase, our net proceeds from the offering were approximately $91.9 million before estimated offering expenses.
Current report
On June 6, 2025, Alexion officially transferred sponsorship of the investigational new drug (“IND”) application for ALXN1840 to Monopar. The FDA acknowledged this change on July 29, 2025, confirming that the transfer was effective as of June 6, 2025. We are now fully responsible for the program, including its commercial advancement and compliance with all applicable federal regulations.
Current report
On September 14-15, 2025, we presented new data on the long-term neurological efficacy and safety of ALXN1840 at the 150th American Neurological Association (ANA) Annual Meeting. Matthew Lorincz, M.D., Ph.D., Professor of Neurology and Co-Director of the Wilson Disease Center of Excellence at the University of Michigan delivered the poster and oral presentations. The analysis pooled efficacy and safety data from the same clinical trials pooled and analyzed for the EASL presentation above. The new findings presented at ANA highlight the long-term neurological benefit of ALXN1840, and follow the EASL presentation of long-term hepatic and systemic safety and efficacy data. Together, these findings underscore the potential of ALXN1840 to favorably impact both neurological and hepatic manifestations of Wilson disease. The ANA data presented highlight the following:
Current report
On November 9, 2025, we presented new data and analyses from the Phase 2 ALXN1840-WD-204 copper balance study at the American Association for the Study of Liver Diseases (AASLD) - The Liver Meeting® 2025. In an oral presentation titled*“Rapidly Improved Cu Balance in Wilson Disease Patients on Tiomolybdate Choline,”* Professor Aftab Ala, MBBS, M.D., FRCP, Ph.D., Professor of Hepatology and Consultant Hepatologist at the Institute of Liver Studies at King’s College Hospital in London, shared results showing that treatment with ALXN1840 (tiomolybdate choline) led to a rapid and sustained improvement in daily copper balance in patients with Wilson disease, primarily through increased fecal copper excretion.
Current report
The mean daily copper balance among patients treated with ALXN1840 in the study (n=8) was significantly lower - indicating improvement - compared with their pre-treatment baseline. Copper balance improved both during the initial 15 mg once-daily dosing period (days 1-28) and over the entire treatment duration (days 1-39), which included patients receiving either 15 mg every other day or 30 mg once daily.
Current report
On September 26, 2025, we received FDA clearance on our IND application for MNPR-101-Lu, which covers the protocol titled* “Phase 1, Open-Label, Multicenter, Dosimetry and Dose-Escalation Trial to Characterize the Safety, Tolerability, and Anti-Tumor Activity of Fractionated MNPR-101-Lu Dosing in the Treatment of uPAR-Expressing Advanced or Metastatic Solid Tumors.”* This IND incorporates our proprietary linker technology, which has been designed to enhance the stability and biodistribution of our therapeutic radiopharmaceuticals.
Current report
The increase in cash flow provided by financing activities during thenine months ended September 30, 2025, compared to thenine months ended September 30, 2024, of $88,803,654 was primarily due to higher net proceeds of approximately $91.9 million, after deducting underwriting discounts and commissions but before offering expenses, from the September 2025 capital raise and Share Repurchase.
Removed paragraphs (3)
Previous report
Cash Flow Provided By (Used in) Investing Activities
Previous report
Cash Flow (Used in) Provided by Financing Activities
Previous report
The decrease in cash flow provided by financing activities during thesix months ended June 30, 2025, compared to thesix months ended June 30, 2024, of $3,604,489 was primarily due to higher net proceeds of $3.2 million from sales of our common stock under at-the-market sales programs in 2024 whereas in 2025 there were no similar financing activities.
Reworded paragraphs (18)
Previous wording
Our cash, cash equivalents and investments as of June 30, 2025, were $53.3 million. As discussed further below and elsewhere in this Quarterly Report, we expect that our current funds will be sufficient at least through December 31, 2026, in order for us to: (1) assemble a regulatory package and file an NDA for the in-licensed ALXN1840 investigational drug candidate for Wilson disease; (2) continue to conduct and conclude our first-in-human imaging and dosimetry clinical trial with MNPR-101-Zr; (3) continue to conduct our first-in-human therapeutic clinical trial of MNPR-101-Lu; (4) advance our preclinical MNPR-101-Ac program into the clinic; and (5) invest in internal R&D projects to expand our radiopharmaceutical pipeline.
Current wording
Our cash, cash equivalents and investments as of September 30, 2025, were $143.7 million. As discussed further below and elsewhere in this Quarterly Report, we expect that our current funds will be sufficient at least through December 31, 2027, in order for us to: (1) assemble a regulatory package and file an NDA for the in-licensed ALXN1840 investigational drug candidate for Wilson disease; (2) continue to conduct and conclude our first-in-human imaging and dosimetry clinical trial with MNPR-101-Zr, continue to conduct our first-in-human therapeutic clinical trial of MNPR-101-Lu, and advance our preclinical MNPR-101-Ac program into the clinic; and (3) invest in internal R&D projects to expand our radiopharmaceutical pipeline.
Previous wording
While our significant accounting policies are described Note 2 of our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q, we believe the following accounting policies to be critical to the judgments and estimates used in the preparation of our condensed consolidated financial statements.
Current wording
While our significant accounting policies are described in Note 2 of our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q, we believe the following accounting policies to be critical to the judgments and estimates used in the preparation of our condensed consolidated financial statements.
Previous wording
Stock-based compensation costs for stock awards granted to our employees, non-employee directors and consultants are based on the fair value of the underlying instruments calculated using the Black-Scholes option-pricing model on the date of grant for stock options and using the closing stock price on the date of grant for RSUs and recognized as an expense on a straight-line basis. Determining the appropriate fair value model and related assumptions requires judgment, including selecting methods for estimating our future stock price volatility and expected holding term. During the sixmonths ended June 30, 2025, we granted 2,000 options to purchase shares of our common stock to a consultant, 52,766 options to purchase shares of our common stock to non-employee directors, 154,204 options to purchase shares of our common stock to officers, and 16,911 options to purchase shares of our common stock to non-officer employees. The expected stock price volatility is based on an analysis of the Company’s stock price history over a period commensurate with the expected term of the options, trading volume of the Company’s stock, look-back volatilities and Company specific events that affected volatility in a prior period. Forfeitures only include actual forfeitures to-date as the Company accounts for forfeitures as they occur due to a limited history of forfeitures. The expected term for options granted to date is estimated using the simplified method. We have not paid dividends and do not anticipate paying a cash dividend in future vesting periods and, accordingly, use an expected dividend yield of zero. The risk-free interest rate is based on the rate of U.S. Treasury securities with maturities consistent with the estimated expected term of the awards.
Current wording
Stock-based compensation costs for stock awards granted to our employees, non-employee directors and consultants are based on the fair value of the underlying instruments calculated using the Black-Scholes option-pricing model on the date of grant for stock options and using the closing stock price on the date of grant for RSUs and recognized as an expense on a straight-line basis. Determining the appropriate fair value model and related assumptions requires judgment, including selecting methods for estimating our future stock price volatility and expected holding term. During the nine months ended September 30, 2025, we granted 2,000 options to purchase shares of our common stock to a consultant, 52,766 options to purchase shares of our common stock to non-employee directors, 154,204 options to purchase shares of our common stock to officers, and 39,411 options to purchase shares of our common stock to non-officer employees. The expected stock price volatility is based on an analysis of the Company’s stock price history over a period commensurate with the expected term of the options, trading volume of the Company’s stock, look-back volatilities and Company specific events that affected volatility in a prior period. Forfeitures only include actual forfeitures to-date as the Company accounts for forfeitures as they occur due to a limited history of forfeitures. The expected term for options granted to date is estimated using the simplified method. We have not paid dividends and do not anticipate paying a cash dividend in future vesting periods and, accordingly, use an expected dividend yield of zero. The risk-free interest rate is based on the rate of U.S. Treasury securities with maturities consistent with the estimated expected term of the awards.
Previous wording
Comparison of the Three and Six Months Ended June 30, 2025 and 2024
Current wording
Comparison of the Three and Nine Months Ended September 30, 2025 and 2024
Previous wording
The following table summarizes the results of our operations for the three and six months ended June 30, 2025 and 2024:
Current wording
The following table summarizes the results of our operations for the three and nine months ended September 30, 2025 and 2024:
Previous wording
R&D expenses for the six months ended June 30, 2025, were $3,373,375, compared to $2,097,088 for the six months ended June 30, 2024. This represents an increase of$1,276,287 attributed to (1) a $1,246,824 increase in R&D personnel expenses including stock-based compensation and (2) a net increase of $29,463 in other R&D expenses.
Current wording
R&D expenses for the three months ended September 30, 2025, were $2,589,749, compared to $984,278 for the three months ended September 30, 2024. This represents an increase of$1,605,471 attributed to (1) a $937,582 increase in manufacturing activities related to ALXN1840, (2) a $617,667 increase in R&D personnel expenses including stock-based compensation and (3) a net increase of $50,223 in other R&D expenses.
Previous wording
R&D expenses for the three months ended June 30, 2025, were $1,730,000, compared to $1,130,978 for the three months ended June 30, 2024. This represents an increase of$599,023 attributed to (1) a $636,300 increase in R&D personnel expenses including stock-based compensation, partially offset by (2) a net decrease of $37,277 in other R&D expenses.
Current wording
R&D expenses for thenine months ended September 30, 2025, were $5,963,124, compared to $3,081,366 for thenine months ended September 30, 2024. This represents an increase of$2,881,758 attributed to (1) a $1,199,119 increase in manufacturing activities related to ALXN1840 and (2) a $1,864,491 increase in R&D personnel expenses including stock-based compensation partially offset by (3) a net decrease of $181,852 in other R&D expenses.
Previous wording
G&A expenses for the three months ended June 30, 2025, were $1,504,295, compared to $657,806 for the three months ended June 30, 2024. This represents an increase of $846,489 primarily attributed to (1) a $370,103 increase in Board compensation resulting from the grant of stock options in March 2025 (no stock options were granted to the Board in 2024), (2) a $255,650 increase in G&A personnel expenses including stock-based compensation, (3) a $114,322 increase in legal fees, (4) a $63,200 increase in state franchise taxes and (5) a $41,416 increase in insurance expenses and (6) a net increase of $1,798 in other G&A expenses.
Current wording
G&A expenses for the three months ended September 30, 2025, were $1,503,326, compared to $590,624 for the three months ended September 30, 2024. This represents an increase of $912,702 primarily attributed to (1) a $369,959 increase in Board compensation resulting from the grant of stock options in March 2025 (no stock options were granted to the Board in 2024), (2) a $287,749 increase in G&A personnel expenses including stock-based compensation, and (3) a net increase of $254,993 in other G&A expenses.
Previous wording
G&A expenses for the six months ended June 30, 2025, were $3,082,737, compared to $1,415,087 for the six months ended June 30, 2024. This represents an increase of $1,667,651 primarily attributed to (1) a $786,548 increase in Board compensation resulting from the grant of stock options in March 2025 (no stock options were granted to the Board in 2024), (2) a $546,745 increase in G&A personnel expenses including stock-based compensation, (3) a $187,244 increase in legal fees, (4) a $82,832 increase in insurance expenses, (5) a $63,200 increase in state franchise taxes and (6) a net increase of $1,082 in other G&A expenses.
Current wording
G&A expenses for thenine months ended September 30, 2025, were $4,586,063, compared to $2,005,711 for thenine months ended September 30, 2024. This represents an increase of $2,580,352 primarily attributed to (1) a $1,156,506 increase in Board compensation resulting from the grant of stock options in March 2025 (no stock options were granted to the Board in 2024), (2) a $834,495 increase in G&A personnel expenses including stock-based compensation, (3) a $229,817 increase in legal fees, (4) a $124,248 increase in insurance expenses, and (5) a net increase of $235,286 in other G&A expenses.
Previous wording
Interest income for the three months ended June 30, 2025, increased by $707,294 compared to the same period in 2024. The increase is attributed to interest earned on U.S. Treasury securities and higher bank balances in 2025, resulting from over $55 million of funds raised in the fourth quarter of 2024.
Current wording
Interest income for the three months ended September 30, 2025, increased by $556,129 compared to the same period in 2024. The increase is attributed to interest earned on U.S. Treasury securities and higher bank balances in 2025, resulting from net proceeds of approximately $91.9 million, after deducting underwriting discounts and commissions but before offering expenses, from the September 2025 capital raise and Share Repurchase.
Previous wording
Interest income for the six months ended June 30, 2025, increased by $1,221,974 compared to the same period in 2024. The increase is attributed to interest earned on U.S. Treasury securities and higher bank balances in 2025, resulting from over $55 million of funds raised in the fourth quarter of 2024.
Current wording
Interest income for thenine months ended September 30, 2025, increased by $1,778,103 compared to the same period in 2024. The increase is attributed to interest earned on U.S. Treasury securities and higher bank balances in 2025, resulting from net proceeds of approximately $91.9 million, after deducting underwriting discounts and commissions but before offering expenses, from the September 2025 capital raise and Share Repurchase.
Previous wording
We have incurred losses and cumulative negative cash flows from operations since we commenced operations resulting in an accumulated deficit of approx imately $80.9 millionas of June 30, 2025. We anticipate that we will continue to incur losses for the foreseeable future. We expect that our R&D and G&A expenses will increase to enable the execution of our strategic plan. We anticipate that the currently available funds as of July 31, 2025, will fund our planned operations at least through December 31, 2026. We will seek to obtain needed capital through a variety of methods, including but not limited to the sale of our common stock, debt financing, strategic partnerships or other sources of capital at our disposal.
Current wording
We have incurred losses and cumulative negative cash flows from operations since we commenced operations resulting in an accumulated deficit of approx imately $84.3 millionas of September 30, 2025. We anticipate that we will continue to incur losses for the foreseeable future. We expect that our R&D and G&A expenses will increase to enable the execution of our strategic plan. We anticipate that the currently available funds as of October 31, 2025, will fund our planned operations at least through December 31, 2027. We will seek to obtain needed capital through a variety of methods, including but not limited to the sale of our common stock, debt financing, strategic partnerships or other sources of capital at our disposal.
Previous wording
The following table provides information regarding our cash flows for the six months ended June 30, 2025 and 2024.
Current wording
The following table provides information regarding our cash flows for the nine months ended September 30, 2025 and 2024.
Previous wording
During the six months ended June 30, 2025 and 2024, we had a net cash outflow of $6,314,353 and $1,146,149, respectively. During the six months ended June 30, 2025, versus the six months ended June 30, 2024, the increase in net cash outflow of $5,168,204 primarily consisted of (1) an increase in net cash provided by investing activities due to certain investment maturities versus purchases of investments, partially offset by (2) an increase in net cash used in operating activities of $3,408,466 and (3) a decrease in cash flow provided by financing activities of $3,604,489 due to the sales of shares of our common stock under at-the-market sales programs during the six months ended June 30, 2024 and no similar financing activities in the comparable period of 2025.
Current wording
During thenine months ended September 30, 2025 and 2024, we had a net cash inflow of $81,861,071 and a net cash outflow of $1,245,996, respectively. During thenine months ended September 30, 2025, versus thenine months ended September 30, 2024, the increase in net cash inflow of $83,107,067 primarily consisted of (1) an increase in cash flow provided by financing activities of $88,803,654 due to the net proceeds of approximately $91.9 million, after deducting underwriting discounts and commissions but before offering expenses, from the September 2025 capital raise and Share Repurchase, partially offset by (2) an increase in net cash used in investing activities due to purchases of investments of $1,264,561 and (3) an increase in net cash used in operating activities of $4,425,498.
Previous wording
The increase of $3,408,466 in cash flow used in operating activities during thesix months ended June 30, 2025, compared to thesix months ended June 30, 2024, was primarily a result of a higher net loss due to an increase in research and development expenses and a payment of$3 million related to ALXN1840 in 2025.
Current wording
The increase of $4,425,498 in cash flow used in operating activities during thenine months ended September 30, 2025, compared to thenine months ended September 30, 2024, was primarily a result of a higher net loss due to an increase in research and development expenses and a payment of$3 million related to ALXN1840 in 2025.
Previous wording
The increase of $1,847,196 in cash provided by investing activities during thesix months ended June 30, 2025, compared to thesix months ended June 30, 2024, was primarily a result of net investment in U.S. Treasury securities maturing and/or invested in during the periods reported.
Current wording
The increase of $1,264,561 in cash used in investing activities during thenine months ended September 30, 2025, compared to thenine months ended September 30, 2024, was primarily a result of net investment in U.S. Treasury securities maturing and/or invested in during the periods reported.
Previous wording
On October 23, 2024, we executed a License Agreement with Alexion, pursuant to which Alexion granted us an exclusive worldwide license for the development and commercialization of ALXN1840, a drug candidate for Wilson disease. As initial upfront consideration for the License Agreement, we issued Alexion 387,329 shares (representing 9.9% of our outstanding shares at the time) of our common stock and agreed to make an upfront cash payment of $4.0 million. The foregoing cash payment was comprised of $1.0 million paid at the time of signing and the remaining $3.0 million paid in January 2025, pursuant to the terms of the agreement. As of June 30, 2025, we have paid an aggregate of $4.0 million in cash under the License Agreement. We agreed to an anti-dilution provision that entitled Alexion to receive additional shares at no cost to maintain their 9.9% ownership until we raised the next $25.0 million of our common stock, subject to a maximum of 705,015 shares unless we obtained stockholder approval. Pursuant to the anti-dilution right, we issued an additional 157,188 shares of common stock to Alexion. No further obligations exist pursuant to the anti-dilution right.
Current wording
On October 23, 2024, we executed a License Agreement with Alexion, pursuant to which Alexion granted us an exclusive worldwide license for the development and commercialization of ALXN1840, a drug candidate for Wilson disease. As initial upfront consideration for the License Agreement, we issued Alexion 387,329 shares (representing 9.9% of our outstanding shares at the time) of our common stock and agreed to make an upfront cash payment of $4.0 million. The foregoing cash payment consisted of $1.0 million paid at the time of signing and the remaining $3.0 million paid in January 2025, pursuant to the terms of the agreement. As of September 30, 2025, we have paid an aggregate of $4.0 million in cash under the License Agreement. We agreed to an anti-dilution provision that entitled Alexion to receive additional shares at no cost to maintain their 9.9% ownership until we raised the next $25.0 million of our common stock, subject to a maximum of 705,015 shares unless we obtained stockholder approval. Pursuant to the anti-dilution right, we issued an additional 157,188 shares of common stock to Alexion. No further obligations exist pursuant to the anti-dilution right.
Previous wording
We recently entered into a 36-month lease that commenced on April 1, 2025, for our executive headquarters at 1000 Skokie Blvd in the Village of Wilmette, Illinois, at a monthly rate of $3,580 per month, and we also have a month-to-month lease for additional space at the same location for $2,379 per month. We also entered into a lease that commenced on January 16, 2025, for a small wet laboratory space and certain equipment at the Helix 51 Bioscience Incubator at The Rosalind Franklin University of Medicine and Science in North Chicago, Illinois, at a rate of $1,000 per month, which is cancellable after 6 months with 30 days advance written notice.
Current wording
We entered into a 36-month lease that commenced on April 1, 2025, for our executive headquarters at 1000 Skokie Blvd in the Village of Wilmette, Illinois, at a monthly rate of $3,580 per month; we also have a month-to-month lease for additional space at the same location for $2,379 per month. We also entered into a lease that commenced on January 16, 2025, for a small wet laboratory space and certain equipment at the Helix 51 Bioscience Incubator at The Rosalind Franklin University of Medicine and Science in North Chicago, Illinois, at a rate of $1,000 per month, which is cancellable after 6 months with 30 days advance written notice.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
Cash Flow Used in Investing Activities
Current report — wording carried from elsewhere
Cash Flow Provided by Financing Activities