Monopar Therapeutics
For the period ended Jun 30, 2026. Filed Aug 12, 2026.
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.
Jun 30, 2026 · Filed Aug 12, 2026
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 2026-03-31; filed 2026-05-14.
0001437749-26-016982
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-12.
0001437749-26-027164
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 94 previous paragraphs and 106 current paragraphs.
72 unchanged; 20 reworded; 13 added; 2 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 13 previous and 19 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 (13)
Current report
On May 19, 2026,Hepatology Communications published a peer-reviewed manuscript entitled* “Effect of Tiomolibdate Choline on Copper Balance in Patients with Wilson Disease: an Open-label Phase 2 Trial.”* The publication reported results from the Phase 2 ALXN1840-WD-204 study (NCT04573309) and demonstrated that ALXN1840 produces a rapid, statistically significant, and sustained improvement in daily copper balance in patients with Wilson disease, driven by increased fecal copper excretion. The publication builds on a recently published peer-reviewed Journal of Hepatology Letter to the Editor, which highlighted the importance of comparing outcomes to a pre-treatment baseline to accurately assess the effect of a potential Wilson disease treatment on copper balance. Key findings reported in the publication include:
Current report
Notably, the observed improvements in copper balance and copper mobilization occurred in a Wilson disease patient population with a mean duration of 16 years on SoC, suggesting that despite years of treatment with currently available therapies, patients present with a considerable amount of residual copper in the body that ALXN1840 is able to mobilize and eliminate. This finding is consistent with data from the completed 48-week Phase 3 trial, in which ALXN1840 demonstrated superior copper mobilization compared to SoC even in patients with a mean prior SoC treatment duration of 11 years.
Current report
On May 29, 2026, we presented Phase 2 ALXN1840-WD-205 data at the EASL Congress 2026. In a presentation titled*“ALXN1840 (tiomolibdate choline) Stabilizes Liver Disease and Improves Neurological Symptoms as well as Quality of Life in Treatment-Experienced Wilson Disease Patients,”*we presented results from the open-label, multicenter Phase 2 trial evaluating the effects of ALXN1840 on liver pathology and clinical outcomes in heavily pre-treated patients with Wilson disease. Key findings presented at EASL 2026 include:
Current report
These results, in a heavily pre-treated Wilson disease population, demonstrate that ALXN1840 can stabilize liver disease and provide clinically meaningful improvements in neurologic symptoms and quality of life. The neurologic and quality of life findings from this study complement the increased copper mobilization and clinical improvement shown in the completed Phase 3 pivotal trial (Study WTX101-301).
Current report
On June 28, 2026, we presented new analyses from the Phase 3 FoCus randomized controlled clinical trial of ALXN1840 at the 12th Congress of the European Academy of Neurology (EAN 2026). These analyses build upon the previously reported Phase 3 FoCus results demonstrating ALXN1840 met its primary endpoint of superior copper mobilization versus SoC. In an encore poster presentation titled*“Greater clinical benefit with tiomolibdate choline versus standard of care in neurologic Wilson disease patients in the Phase 3 FoCus Trial,”* we presented results showing that ALXN1840 produced significant neurologic improvement over time and greater global clinical improvement compared to SoC therapy in Wilson disease patients with neurologic symptoms at baseline. ALXN1840 also demonstrated similar or better outcomes compared to SoC across a range of psychiatric and hepatic measures during the 48-week study. In the subset of patients with neurologic symptoms at baseline from the 2:1 randomized Phase 3 FoCus clinical trial (NCT03403205; n=207), ALXN1840 demonstrated improved outcomes compared to SoC across multiple clinical measures:
Current report
Across Phase 2 and Phase 3 studies, ALXN1840 has demonstrated a well-characterized and favorable safety profile in 266 patients, with a median treatment duration of 2.58 years and maximum exposure of more than 8 years. Drug-related serious adverse events (SAEs) occurred in 4.9% of patients, including neurologic SAEs in less than 1% and no treatment-related deaths.
Current report
On June 30, 2026, the FDA granted Rare Pediatric Disease (RPD) designation to ALXN1840. The FDA grants RPD designation to therapies intended to treat serious or life-threatening diseases that primarily affect children from birth to 18 years of age. The designation provides us with the potential at the time of NDA approval to receive a pediatric Priority Review Voucher (PRV), which can be used to obtain priority review of a subsequent marketing application or sold or transferred to another sponsor. Priority review can reduce the FDA’s target review time by several months.
Current report
We announced on July 22, 2026, that we have initiated a rolling submission of our NDA for ALXN1840, and we anticipate completing the submission within the next few months. There can be no assurance that, following completion of the rolling submission, the FDA will accept the NDA for filing or that the NDA will ultimately be approved.
Current report
R&D expenses for the six months ended June 30, 2026, were $8,254,079 compared to $3,373,375 for the six months ended June 30, 2025. This represents an increase of $4,880,704 primarily attributed to (1) a$2,852,822 increase in R&D contractor and consulting expenses, (2) a $1,520,821 increase in R&D personnel expenses including stock-based compensation, (3) a $489,537 increase inmanufacturing activities related to ALXN1840 and (4) a net increase of $17,524 in other R&D expenses.
Current report
G&A expenses for the six months ended June 30, 2026, were$3,615,837, compared to $3,082,737 for the six months ended June 30, 2025. This represents an increase of $533,100 primarily attributed to (1) a $368,712 increase in G&A personnel expenses including stock-based compensation, (2) a$286,301 increase in G&A contractor and consulting expenses, and (3) a net decrease of$121,913 in other G&A expenses.
Current report
Other Income (loss)
Current report
Other income for the three and six months ended June 30, 2026, was$32,158; there was no other income forthe three months ended June 30, 2025. The increase is primarily attributable to an adjustment to a vendor invoice recognized during the current period.
Current report
Interest Income (loss)
Removed paragraphs (2)
Previous report
Based on recent regulatory interactions with the FDA regarding ALXN1840, during which the agency has encouraged continued dialogue with us on certain questions before we submit our NDA, we currently expect to submit our NDA in mid-2026. This anticipated timing reflects our efforts to incorporate additional information and further refine the submission package. However, there can be no assurance that the FDA will accept the NDA for filing or that the application will ultimately be approved.
Previous report
Interest Income
Reworded paragraphs (20)
Previous wording
Our cash, cash equivalents and investments as of March 31, 2026, were $137.5 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.
Current wording
Our cash, cash equivalents and investments as of June 30, 2026, were $134.3 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, 2027, in order for us to: (1) assemble a regulatory package, complete the rolling submission of the NDA and initiate pre-commercial activities 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
On December 23, 2024, we sold 798,655 shares of our common stock at $23.79 per share in a public offering. Concurrent with that offering, we completed a private placement of pre-funded warrants to purchase 882,761 shares of common stock at a purchase price of $23.789 per pre-funded warrant to an institutional investor. The net proceeds of the shares and the pre-funded warrants sold were approximately $37.4 million after fees, commissions and other offering costs.
Current wording
On December 23, 2024, we sold 798,655 shares of our common stock at $23.79 per share in a public offering. Concurrent with that offering, we completed a private placement of pre-funded warrants to purchase 882,761 shares of common stock at a purchase price of $23.789 per pre-funded warrant, reflecting the $0.001 exercise price, to an institutional investor. The net proceeds of the shares and the pre-funded warrants sold were approximately $37.4 million after fees, commissions and other offering costs.
Previous wording
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,”* we 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 wording
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,”* we shared results showing that treatment with ALXN1840 led to a rapid and sustained improvement in daily copper balance in patients with Wilson disease, primarily through increased fecal copper excretion.
Previous wording
On April 19, 2026, at the American Academy of Neurology Annual Meeting (AAN), new analyses were presented from the Phase 3 FoCus trial of ALXN1840 showing greater neurologic benefit versus standard of care in Wilson disease patients with neurologic symptoms at baseline, with durable neurologic benefit observed over multiple years of treatment. The data presented highlight the following:
Current wording
On April 19, 2026, at the American Academy of Neurology Annual Meeting (AAN), new analyses were presented from the Phase 3 FoCus trial of ALXN1840 showing greater neurologic benefit versus SoC in Wilson disease patients with neurologic symptoms at baseline, with durable neurologic benefit observed over multiple years of treatment. The data presented highlight the following:
Previous wording
We are also actively exploring opportunities to expand our radiopharmaceutical pipeline primarily through internal development efforts. In October 2024, we announced the filing of a provisional patent application for new radiopharmaceutical compounds and a family of linkers used to connect radioisotopes with targeting agents, including our uPAR-targeting antibody MNPR-101. In March 2025, we filed a corresponding international patent application claiming priority to the October 2024 provisional filing (International Patent Application No. PCT/US2025/021595).
Current wording
We are also exploring opportunities to expand our radiopharmaceutical pipeline primarily through internal development efforts. In October 2024, we announced the filing of a provisional patent application for new radiopharmaceutical compounds and a family of linkers used to connect radioisotopes with targeting agents, including our uPAR-targeting antibody MNPR-101. In March 2025, we filed a corresponding international patent application claiming priority to the October 2024 provisional filing (International Patent Application No. PCT/US2025/021595).
Previous wording
Two accounting pronouncements, detailed in Note 2 of our condensed consolidated financial statements in this Quarterly Report on Form 10-Q, are under consideration for adoption as of March 31, 2026.
Current wording
Three accounting pronouncements, detailed in Note 2 of our condensed consolidated financial statements in this Quarterly Report on Form 10-Q, are under consideration for adoption as of June 30, 2026.
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 three months ended March 31, 2026, we granted 2,000 options to purchase shares of our common stock to a consultant, 48,728 options to purchase shares of our common stock to officers, and 11,500 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 six months ended June 30, 2026, we granted 2,000 options to purchase shares of our common stock to a consultant, 1,284 options to purchase shares of our common stock to non-employee directors, 48,728 options to purchase shares of our common stock to officers, and 13,300 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 Months Ended March 31, 2026 and 2025
Current wording
Comparison of the Three and Six Months Ended June 30, 2026 and 2025
Previous wording
The following table summarizes the results of our operations for the three months ended March 31, 2026 and 2025:
Current wording
The following table summarizes the results of our operations for the three and six months ended June 30, 2026 and 2025:
Previous wording
R&D expenses for the three months ended March 31, 2026, were $3,487,247 compared to $1,643,375 for the three months ended March 31, 2025. This represents an increase of $1,843,872 primarily attributed to (1) an $825,972 increase in R&D contractor and consulting expenses, (2) a $799,593 increase in R&D personnel expenses including stock-based compensation and (3) a net increase of $218,307 in other R&D expenses.
Current wording
R&D expenses for the three months ended June 30, 2026, were$4,766,832 compared to $1,730,000 for the three months ended June 30, 2025. This represents an increase of $3,036,831 primarily attributed to (1) a$2,026,851 increase in R&D contractor and consulting expenses, (2) a $721,228 increase in R&D personnel expenses including stock-based compensation and (3) a net increase of $288,752 in other R&D expenses.
Previous wording
G&A expenses for the three months ended March 31, 2026, were $1,738,006, compared to $1,578,442 for the three months ended March 31, 2025. This represents an increase of $159,564 primarily attributed to (1) a $134,599 increase in G&A personnel expenses including stock-based compensation, and (2) a net increase of $24,965 in other G&A expenses.
Current wording
G&A expenses for the three months ended June 30, 2026, were $1,877,831, compared to $1,504,295 for the three months ended June 30, 2025. This represents an increase of $373,536 primarily attributed to (1) a $234,113 increase in G&A personnel expenses including stock-based compensation, (2) a $198,988 increase in G&A contractor and consulting expenses, and (3) a net decrease of $59,565 in other G&A expenses
Previous wording
Interest income for the three months ended March 31, 2026, was $1,332,203 compared to $596,845 forthe three months ended March 31, 2025. The increase is attributed to interest earned on U.S. Treasury securities and commercial paper, and higher bank balances in 2026, due to the net proceeds of approximately $91.9 million from the September 2025 capital raise.
Current wording
Interest income for the three months ended June 30, 2026, was$1,299,205 compared to $780,769 forthe three months ended June 30, 2025. The increase is attributed to interest earned on U.S. Treasury securities and commercial paper and to higher bank balances in 2026 due to the net proceeds of approximately $91.9 million from the September 2025 capital raise.
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 $93.4 millionas of March 31, 2026. We anticipate that we will continue to incur losses for the foreseeable future. We expect that our R&D and Selling, General and Administrative (“SG&A”) expenses will increase to enable the execution of our strategic plan, including our ALXN1840 pre-commercial activities and, if approved, commercialization activities. We anticipate that the currently available funds as of March 31, 2026, 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.
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 $98.7 millionas of June 30, 2026. We anticipate that we will continue to incur losses for the foreseeable future. We expect that our R&D and General and Administrative (“G&A”) expenses will increase to enable the execution of our strategic plan, including our ALXN1840 pre-commercial activities and, if approved, commercialization activities. We anticipate that the available funds as of July 31, 2026, 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 three months ended March 31, 2026 and 2025.
Current wording
The following table provides information regarding our cash flows for the six months ended June 30, 2026 and 2025.
Previous wording
During thethree months ended March 31, 2026 and 2025, we had a net cash outflow of $9,289,289 and a net cash outflow of $6,104,880, respectively. The net change in cash and cash equivalents as of thethree months ended March 31, 2026, compared to thethree months ended March 31, 2025, primarily consisted of (1) an increase in cash outflow used in investing activities of $5,257,724, which is primarily due to increased investment activity following the $91.9 million in net proceeds from the September 2025 capital raise, partially offset by (2) a decrease in net cash used in operating activities of $2,189,410 due to the payment of $3 million related to ALXN1840 in 2025 (no similar payment was made in 2026).
Current wording
During thesix months ended June 30, 2026 and 2025, we had a net cash outflow of $9,075,786 and a net cash outflow of $6,314,353, respectively. The net change in cash and cash equivalents as of thesix months ended June 30, 2026, compared to thesix months ended June 30, 2025, primarily consisted of (1) an increase in cash outflow used in investing activities of $2,329,546, which is primarily due to increased investment activity following the $91.9 million in net proceeds from the September 2025 capital raise and (2) an increase in net cash used in financing activities of $415,065 primarily due tohigher net share settlement taxes on vested RSUs, reflecting both a higher number of awards vesting and an increase in our stock price compared to the corresponding vesting dates in 2025.
Previous wording
The decrease of $2,189,410 in cash flow used in operating activities during thethree months ended March 31, 2026, compared to thethree months ended March 31, 2025, was primarily a result of a payment of $3 million related to ALXN1840 in 2025 (no similar payment was made in 2026).
Current wording
The decrease of $19,344 in cash flow used in operating activities during the six months ended June 30, 2026, compared to the six months ended June 30, 2025, was primarily due to the absence of a $3.0 million in-process research and development payment related to ALXN1840 that was made in 2025, largely offset by a higher net loss in the current period.
Previous wording
The increase of $5,257,724 in cash flow used in investing activities during thethree months ended March 31, 2026, compared to thethree months ended March 31, 2025, was primarily a result of an increase in net investment in U.S. Treasury securities and commercial paper maturing and/or invested in during the periods reported.
Current wording
The increase of $2,329,546 in cash flow used in investing activities during thesix months ended June 30, 2026, compared to thesix months ended June 30, 2025, was primarily a result of an increase in net investment in U.S. Treasury securities and commercial paper maturing and/or invested in during the periods reported.
Previous wording
The increase of $84,521 in cash flow used in financing activities during thethree months ended March 31, 2026, compared to thethree months ended March 31, 2025, was primarily a result of higher net share settlement taxes on vested RSUs in 2026.
Current wording
The increase of$415,065 in cash flow used in financing activities during thesix months ended June 30, 2026, compared to thesix months ended June 30, 2025, was primarily a result of higher net share settlement taxes on vested RSUs, reflecting both a higher number of awards vesting and an increase in our stock pricein 2026.
Previous wording
We anticipate that the funds available as of April 30, 2026, will fund our obligations at least through December 31, 2027. We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our drug product candidates, and the extent to which we enter into collaborations with third parties to participate in the development and commercialization of our drug product candidates, we are unable to accurately estimate with high reliability the amounts and timing required for increased capital outlays and operating expenditures associated with our current and anticipated drug product candidate development programs.
Current wording
We anticipate that the funds available as of July 31,2026, will fund our obligations at least through December 31, 2027. We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our drug product candidates, and the extent to which we enter into collaborations with third parties to participate in the development and commercialization of our drug product candidates, we are unable to accurately estimate with high reliability the amounts and timing required for increased capital outlays and operating expenditures associated with our current and anticipated drug product candidate development programs.
Previous 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. On November 1, 2025, we entered into an additional 36-month lease at the same location at a monthly rate of $5,002, which replaced a previous month-to-month arrangement for that space. Additionally, on March 22, 2026, we entered into a one-year lease commencing January 16, 2026, 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 $875 per month.
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. On November 1, 2025, we entered into an additional 36-month lease at the same location at a monthly rate of $5,002, which replaced a previous month-to-month arrangement for that space. Additionally, on March 22, 2026, we entered into a one-year lease commencing January 16, 2026, 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 $875 per month. On June 11, 2026, we entered into an additional 36-month lease for Suite 100 at 1000 Skokie Blvd in the Village of Wilmette, Illinois, with the 36-month term to commence upon the Landlord’s delivery of the space after substantially completing the agreed-upon improvements.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Interest income for the six months ended June 30, 2026, was $2,631,408 compared to $1,377,614 for the six months ended June 30, 2025. The increase is attributed to interest earned on U.S. Treasury securities and commercial paper and to higher bank balances in 2026 due to the net proceeds of approximately $91.9 million from the September 2025 capital raise.