Monopar Therapeutics Reports Second聽Quarter 2025聽Financial Results and Recent Developments
Monopar Therapeutics (Nasdaq: MNPR) reported its Q2 2025 financial results and key developments. The company ended Q2 with $53.3 million in cash, expected to fund operations through December 2026. Notable developments include the transfer of ALXN1840's IND from Alexion Pharmaceuticals, with plans to submit an NDA in early 2026 for Wilson Disease treatment.
The company reported a Q2 2025 net loss of $2.5 million ($0.35 per share), compared to $1.7 million ($0.49 per share) in Q2 2024. R&D expenses increased to $1.73 million, while G&A expenses rose to $1.50 million. Their MNPR-101 radiopharmaceutical program continues with active Phase 1 trials in Australia and an Expanded Access Program in the U.S.
Monopar Therapeutics (Nasdaq: MNPR) ha pubblicato i risultati finanziari del Q2 2025 e i principali sviluppi. La societ脿 ha chiuso il trimestre con $53.3 milioni in cassa, importo che dovrebbe finanziare le operazioni fino a dicembre 2026. Tra gli sviluppi rilevanti c'猫 il trasferimento dell'IND di ALXN1840 da Alexion Pharmaceuticals, con l'intenzione di presentare una NDA all'inizio del 2026 per il trattamento della malattia di Wilson.
La societ脿 ha registrato una perdita netta nel Q2 2025 di $2.5 milioni ($0.35 per azione), rispetto a $1.7 milioni ($0.49 per azione) nel Q2 2024. Le spese di ricerca e sviluppo (R&D) sono salite a $1.73 milioni, mentre le spese generali e amministrative (G&A) sono aumentate a $1.50 milioni. Il programma radiofarmaceutico MNPR-101 prosegue con studi di Fase 1 attivi in Australia e un Programma di Accesso Espanso negli Stati Uniti.
Monopar Therapeutics (Nasdaq: MNPR) inform贸 sus resultados financieros del Q2 2025 y los desarrollos clave. La compa帽铆a cerr贸 el trimestre con $53,3 millones en efectivo, monto que se espera financie las operaciones hasta diciembre de 2026. Entre los hitos se incluye la transferencia del IND de ALXN1840 desde Alexion Pharmaceuticals, con planes de presentar una NDA a principios de 2026 para el tratamiento de la enfermedad de Wilson.
La compa帽铆a report贸 una p茅rdida neta en el Q2 2025 de $2,5 millones ($0,35 por acci贸n), frente a $1,7 millones ($0,49 por acci贸n) en el Q2 2024. Los gastos de I+D aumentaron hasta $1,73 millones, mientras que los gastos generales y administrativos (G&A) subieron a $1,50 millones. El programa radiofarmac茅utico MNPR-101 contin煤a con ensayos de Fase 1 activos en Australia y un Programa de Acceso Ampliado en EE. UU.
Monopar Therapeutics (Nasdaq: MNPR)電� 2025雲� 2攵勱赴 鞛 鞁れ爜 氚� 欤检殧 歆勴枆 靷暛鞚� 氚滍憸頄堨姷雼堧嫟. 頃措嫻 攵勱赴 毵� 须岇偓电� 氙疙檾 5,330毵� 雼煬鞚� 順勱笀鞚� 氤挫湢頃橁碃 鞛堨柎 2026雲� 12鞗旉箤歆� 鞖挫榿 鞛愱笀鞚� 於╇嫻頃� 瓴冹溂搿� 鞓堨儊霅╇媹雼�. 欤茧頃� 毵岉暅 歆勴枆 靷暛鞙茧電� ALXN1840鞚� IND臧� Alexion Pharmaceuticals鞐愳劀 鞚挫爠霅� 鞝愳澊 鞛堨溂氅�, Wilson 氤� 旃橂毳� 鞙勴暅 NDA毳� 2026雲� 齑� 鞝滌稖頃� 瓿勴殟鞛呺媹雼�.
须岇偓电� 2025雲� 2攵勱赴 靾滌啇鞁れ澊 氙疙檾 $2.5 million(欤茧嫻 $0.35)鞚措澕瓿� 氤搓碃頄堨溂氅�, 鞚措姅 2024雲� 2攵勱赴鞚� $1.7 million(欤茧嫻 $0.49)瓿� 牍勱祼霅╇媹雼�. 鞐瓣惮臧滊皽牍�(R&D)電� $1.73 million鞙茧 歃濌皜頄堦碃, 鞚茧皹甏�毽箘(G&A)電� $1.50 million鞙茧 電橃棃鞀惦媹雼�. MNPR-101 氚╈偓靹膘潣鞎巾拡 頂勲攴鸽灗鞚� 順胳＜鞐愳劀 歆勴枆 欷戩澑 1靸� 鞁滍棙瓿� 氙戈淡鞚� 頇曤寑 鞝戧芳 頂勲攴鸽灗(Expanded Access Program)鞚� 韱淀暣 瓿勳啀 歆勴枆霅橁碃 鞛堨姷雼堧嫟.
Monopar Therapeutics (Nasdaq: MNPR) a publi茅 ses r茅sultats financiers du T2 2025 et les d茅veloppements cl茅s. La soci茅t茅 a cl么tur茅 le trimestre avec 53,3 millions de $ en tr茅sorerie, montant qui devrait financer les op茅rations jusqu'en d茅cembre 2026. Parmi les faits marquants figure le transfert de l'IND d'ALXN1840 depuis Alexion Pharmaceuticals, avec l'intention de soumettre une NDA d茅but 2026 pour le traitement de la maladie de Wilson.
La soci茅t茅 a d茅clar茅 une perte nette au T2 2025 de 2,5 millions de dollars (0,35 $ par action), contre 1,7 million de dollars (0,49 $ par action) au T2 2024. Les d茅penses de recherche et d茅veloppement (R&D) ont augment茅 脿 1,73 million de $, tandis que les frais g茅n茅raux et administratifs (G&A) ont progress茅 脿 1,50 million de $. Le programme radiopharmaceutique MNPR-101 se poursuit avec des essais de phase 1 actifs en Australie et un programme d'acc猫s 茅largi aux 脡tats-Unis.
Monopar Therapeutics (Nasdaq: MNPR) meldete seine Finanzergebnisse f眉r Q2 2025 und wichtige Entwicklungen. Das Unternehmen schloss das Quartal mit $53,3 Millionen an Barmitteln ab, die voraussichtlich die Gesch盲ftst盲tigkeit bis Dezember 2026 finanzieren. Zu den wichtigsten Entwicklungen geh枚rt die 脺bertragung des IND von ALXN1840 von Alexion Pharmaceuticals, mit Pl盲nen, Anfang 2026 eine NDA zur Behandlung der Wilson-Krankheit einzureichen.
Das Unternehmen wies einen Nettoverlust im Q2 2025 von $2,5 Millionen ($0,35 je Aktie) aus, gegen眉ber $1,7 Millionen ($0,49 je Aktie) im Q2 2024. Die F&E-Ausgaben stiegen auf $1,73 Millionen, w盲hrend die allgemeinen Verwaltungsaufwendungen (G&A) auf $1,50 Millionen zunahmen. Das radiopharmazeutische Programm MNPR-101 l盲uft weiter mit aktiven Phase鈥�1鈥慡tudien in Australien und einem Expanded鈥慉ccess鈥慞rogramm in den USA.
- Strong cash position of $53.3 million, sufficient through December 2026
- Successfully acquired ALXN1840 IND from Alexion Pharmaceuticals
- Multiple active clinical trials for MNPR-101 radiopharmaceutical program
- Decreased loss per share from $0.49 in Q2 2024 to $0.35 in Q2 2025
- Significant increase in interest income from higher cash balances
- Net loss increased to $2.5 million from $1.7 million year-over-year
- R&D expenses increased by $599,023 compared to Q2 2024
- G&A expenses more than doubled to $1.50 million from $657,806 year-over-year
Insights
Monopar's strong $53.3M cash position provides runway through 2026 while advancing Wilson disease drug toward NDA and progressing radiopharmaceutical pipeline.
Monopar's Q2 results reveal a solid financial foundation with
The company's net loss widened to
Monopar's radiopharmaceutical pipeline continues to advance with active enrollment in Phase 1 trials for MNPR-101-Zr (imaging) and MNPR-101-Lu (therapeutic) in Australia, complemented by an Expanded Access Program in the U.S. The company is also progressing preclinical work on MNPR-101-Ac with plans for future clinical trials.
The substantial increase in interest income reflects efficient capital management following their
WILMETTE, Ill., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (鈥淢onopar鈥� or the 鈥淐ompany鈥�) (Nasdaq: MNPR), a clinical鈥恠tage biopharmaceutical company focused on developing innovative treatments for patients with unmet medical needs, today announced second聽quarter 2025 financial results and recent developments.
Recent Developments
ALXN1840 for Wilson Disease
On June 6, 2025, Alexion Pharmaceuticals officially transferred sponsorship of the investigational new drug (鈥淚ND鈥�) application for ALXN1840 to Monopar. The U.S. Food and Drug Administration (鈥淔DA鈥�) acknowledged this change on July 29, 2025, confirming that the transfer was effective as of June 6, 2025. Monopar is now fully responsible for the program, including its commercial advancement and compliance with all applicable federal regulations.
Monopar is preparing to submit a New Drug Application (鈥淣DA鈥�) to the FDA in early 2026.
MNPR鈥�101 for Radiopharmaceutical Use
The Company鈥檚 MNPR-101-Zr Phase 1 (imaging and dosimetry) and MNPR-101-Lu (therapeutic) Phase 1a clinical trials in advanced cancers are active and enrolling in Australia, and the Company鈥檚 Expanded Access Program (also referred to as compassionate use) for MNPR-101-Zr and MNPR-101-Lu is active and enrolling in the U. S. Monopar continues its preclinical work with MNPR-101-Ac (therapeutic) with plans to enter the clinic in the future.
Financial Results for the Second Quarter Ended June 30, 2025, Compared to the Second Quarter Ended June 30, 2024
Cash and Net Loss
Cash, cash equivalents and investments as of June 30, 2025, were
Net loss for the second quarter of 2025 was
Research and Development (鈥淩&D鈥�) Expenses
R&D expenses for the second quarter of 2025 were
General and Administrative (鈥淕&A鈥�) Expenses
G&A expenses for the second quarter of 2025 were
Interest Income
Interest income for the three months ended June 30, 2025, increased聽by
About Monopar Therapeutics Inc.
Monopar Therapeutics is a clinical-stage biopharmaceutical company with late-stage ALXN1840 for Wilson disease, and radiopharmaceutical programs including Phase 1-stage MNPR-101-Zr for imaging advanced cancers, and Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac for the treatment of advanced cancers. For more information, and links to SEC filings that contain detailed financial information, visit:聽https://ir.monopartx.com/quarterly-reports.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The words 鈥渕ay,鈥� 鈥渨ill,鈥� 鈥渃ould,鈥� 鈥渨ould,鈥� 鈥渟hould,鈥� 鈥渆xpect,鈥� 鈥減lan,鈥� 鈥渁nticipate,鈥� 鈥渋ntend,鈥� 鈥渂elieve,鈥� 鈥渆stimate,鈥� 鈥減redict,鈥� 鈥減roject,鈥� 鈥減otential,鈥� 鈥渃ontinue,鈥� 鈥渢arget鈥� and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of these forward-looking statements include statements concerning: that Monopar is responsible for advancing the program commercially; that Monopar is preparing to submit an NDA to the FDA in early 2026; that Monopar continues its preclinical work with MNPR-101-Ac with the plan to enter the clinic in the future; and that Monopar expects that its current funds will be sufficient to continue operations at least through December 31, 2026. The forward-looking statements involve risks and uncertainties including, but not limited to: uncertainties related to the regulatory process that Monopar intends to initiate related to ALXN1840 and the outcome thereof; the rate of market acceptance and competitiveness in terms of pricing, efficacy and safety, of any products for which Monopar receives marketing approval, and Monopar鈥檚 ability to competitively market any such products as compared to larger pharmaceutical firms; Monopar鈥檚 ability to raise sufficient funds in order for the Company to support continued preclinical, clinical, regulatory, precommercial and commercial development of its programs and to make contractual milestone payments, as well as its 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; and the significant general risks and uncertainties surrounding the research, development, regulatory approval, and commercialization of imaging agents and therapeutics. Actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Monopar's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Monopar undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Any forward-looking statements contained in this press release represent Monopar鈥檚 views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
CONTACT:听听
Monopar Therapeutics Inc.
Investor Relations听听
Quan Vu听听
Chief Financial Officer听听
[email protected]听听
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FAQ
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