DiaMedica Therapeutics Provides a Business Update and Announces Full Year 2024 Financial Results
DiaMedica Therapeutics (DMAC) reported its full year 2024 financial results and provided key business updates. The company is advancing two main clinical programs: a Phase 2/3 trial for acute ischemic stroke (ReMEDy2) and a Phase 2 trial for preeclampsia.
Key financial highlights include:
- Cash position of $44.1 million as of December 31, 2024
- Net loss of $24.4 million ($0.60 per share)
- R&D expenses increased to $19.1 million
- G&A expenses decreased to $7.6 million
The company expects preliminary topline safety and efficacy data from Part 1A of the preeclampsia study in Q2 2025. The ReMEDy2 trial has reached 30 activated hospital sites, with interim analysis expected in H1 2026. Cash runway extends into Q3 2026.
DiaMedica Therapeutics (DMAC) ha riportato i risultati finanziari dell'intero anno 2024 e ha fornito aggiornamenti chiave sull'attività. L'azienda sta portando avanti due principali programmi clinici: uno studio di Fase 2/3 per l'ictus ischemico acuto (ReMEDy2) e uno studio di Fase 2 per la preeclampsia.
Le principali evidenze finanziarie includono:
- Posizione di cassa di $44,1 milioni al 31 dicembre 2024
- Perdita netta di $24,4 milioni ($0,60 per azione)
- Le spese per R&S sono aumentate a $19,1 milioni
- Le spese generali e amministrative sono diminuite a $7,6 milioni
L'azienda prevede dati preliminari sulla sicurezza e l'efficacia dalla Parte 1A dello studio sulla preeclampsia nel secondo trimestre del 2025. Lo studio ReMEDy2 ha raggiunto 30 siti ospedalieri attivati, con un'analisi intermedia prevista per la prima metà del 2026. La disponibilità di cassa si estende fino al terzo trimestre del 2026.
DiaMedica Therapeutics (DMAC) informó sus resultados financieros del año completo 2024 y proporcionó actualizaciones clave sobre el negocio. La compañía está avanzando en dos programas clínicos principales: un ensayo de Fase 2/3 para el accidente cerebrovascular isquémico agudo (ReMEDy2) y un ensayo de Fase 2 para la preeclampsia.
Los aspectos financieros clave incluyen:
- Posición de efectivo de $44.1 millones al 31 de diciembre de 2024
- Pérdida neta de $24.4 millones ($0.60 por acción)
- Los gastos de I+D aumentaron a $19.1 millones
- Los gastos generales y administrativos disminuyeron a $7.6 millones
La compañía espera datos preliminares sobre seguridad y eficacia de la Parte 1A del estudio de preeclampsia en el segundo trimestre de 2025. El ensayo ReMEDy2 ha alcanzado 30 sitios hospitalarios activados, con un análisis intermedio esperado en la primera mitad de 2026. La disponibilidad de efectivo se extiende hasta el tercer trimestre de 2026.
DiaMedica Therapeutics (DMAC)는 2024년 전체 연도 재무 결과를 발표하고 주요 사업 업데이트를 제공했습니다. 이 회사는 두 가지 주요 임상 프로그램을 진행하고 있습니다: 급성 허혈성 뇌졸중을 위한 2/3상 시험(ReMEDy2)과 자간전증을 위한 2상 시험입니다.
주요 재무 하이라이트는 다음과 같습니다:
- 2024년 12월 31일 기준 현금 보유액 $44.1백만
- 순손실 $24.4백만 ($0.60 주당)
- 연구개발(R&D) 비용이 $19.1백만으로 증가
- 일반 및 관리(G&A) 비용이 $7.6백만으로 감소
회사는 2025년 2분기에 자간전증 연구의 1A 부분에 대한 초기 안전성 및 유효성 데이터를 예상하고 있습니다. ReMEDy2 시험은 30개의 활성화된 병원 사이트에 도달했으며, 중간 분석은 2026년 상반기에 예상됩니다. 현금 운영 자금은 2026년 3분기까지 연장됩니다.
DiaMedica Therapeutics (DMAC) a publié ses résultats financiers pour l'année complète 2024 et a fourni des mises à jour clés sur ses activités. L'entreprise avance deux programmes cliniques principaux : un essai de phase 2/3 pour l'accident vasculaire cérébral ischémique aigu (ReMEDy2) et un essai de phase 2 pour la prééclampsie.
Les points saillants financiers comprennent :
- Position de trésorerie de $44,1 millions au 31 décembre 2024
- Perte nette de $24,4 millions ($0,60 par action)
- Les dépenses de R&D ont augmenté à $19,1 millions
- Les dépenses générales et administratives ont diminué à $7,6 millions
L'entreprise s'attend à des données préliminaires sur la sécurité et l'efficacité de la Partie 1A de l'étude sur la prééclampsie au deuxième trimestre 2025. L'essai ReMEDy2 a atteint 30 sites hospitaliers activés, avec une analyse intermédiaire prévue pour le premier semestre 2026. La trésorerie est disponible jusqu'au troisième trimestre 2026.
DiaMedica Therapeutics (DMAC) hat seine Finanzzahlen für das gesamte Jahr 2024 veröffentlicht und wichtige Geschäftsupdates bereitgestellt. Das Unternehmen verfolgt zwei Hauptklinische Programme: eine Phase 2/3-Studie für einen akuten ischämischen Schlaganfall (ReMEDy2) und eine Phase 2-Studie für Präeklampsie.
Wichtige finanzielle Highlights umfassen:
- Cash-Position von $44,1 Millionen zum 31. Dezember 2024
- Nettoverlust von $24,4 Millionen ($0,60 pro Aktie)
- F&E-Ausgaben stiegen auf $19,1 Millionen
- Allgemeine und Verwaltungskosten sanken auf $7,6 Millionen
Das Unternehmen erwartet im 2. Quartal 2025 vorläufige Sicherheits- und Wirksamkeitsdaten aus Teil 1A der Präeklampsiestudie. Die ReMEDy2-Studie hat 30 aktivierte Krankenhausstandorte erreicht, mit einer Zwischenanalyse, die für das erste Halbjahr 2026 erwartet wird. Die Cash-Reserven reichen bis ins 3. Quartal 2026.
- Data Safety Monitoring Board confirmed positive safety review for ReMEDy2 trial
- Expanded clinical pipeline with new preeclampsia program
- Strong cash position of $44.1M provides runway into Q3 2026
- Increased site activation to 30 hospitals for ReMEDy2 trial
- Net loss increased to $24.4M from $19.4M year-over-year
- R&D expenses increased 46% to $19.1M
- Cash burn increased with net cash used in operations rising to $22.1M from $18.7M
- Delays in site activation and slower than expected enrollment in ReMEDy2 trial
Insights
DiaMedica's financial results reflect a biotech company in active development phase with a mixed financial picture. The
The net loss of
The decline in G&A expenses to
The appointment of Daniel O'Connor, who previously led Ambrx to a
DiaMedica's dual clinical programs represent distinct risk-reward profiles and timelines. The preeclampsia program is progressing on schedule with multiple dosing cohorts completed and preliminary data expected in Q2 2025. This relatively near-term catalyst could provide important validation for DM199 in this high-unmet-need indication, which currently lacks effective pharmacological interventions.
The acute ischemic stroke (AIS) program shows concerning timeline extensions. Despite reaching 30 activated hospital sites, enrollment delays have pushed the interim analysis to first half of 2026, representing a significant timeline shift. The implementation of protocol version 5.0 with expanded eligibility criteria was necessary to address recruitment challenges but raises questions about execution efficiency.
The positive DSMB review confirming safety of the new intravenous dosing regimen removes one risk factor for the AIS program. However, the company faces the persistent challenge of clinical trial enrollment in stroke - a notoriously difficult therapeutic area with numerous failed development programs.
DiaMedica's strategy of pursuing both indications creates pipeline diversification, with the preeclampsia program potentially delivering earlier proof-of-concept while the larger AIS program progresses. Both indications address substantial unmet medical needs, but the timeline extension for the AIS program creates uncertainty around DiaMedica's development pathway and potential regulatory approval timeframes.
Conference Call and Webcast March 18 at 8:00 AM Eastern Time / 7:00 AM Central Time
- Preeclampsia Phase 2 Trial Preliminary Topline Safety and Efficacy Data from Part 1A of the Study Expected in the Second Quarter of 2025
- Acute Ischemic Stroke Phase 2/3 Program Enrollment Ongoing
- Appointed Experienced Biotech Executive Daniel J. O’Connor to the Board
- Cash Runway into Q3 2026
“We made significant progress in 2024, advancing our AIS program and expanding into preeclampsia,” said Rick Pauls, President and CEO of DiaMedica. “Both of these populations are critically underserved, representing substantial unmet medical needs and large commercial opportunities.”
Preeclampsia Phase 2 Clinical Developments
Dosing in the Phase 2 investigator-sponsored trial of DM199 for preeclampsia (DM199 For Pregnancy Complications trial – NCT06875141) began in November 2024 in
Acute Ischemic Stroke (AIS) ReMEDy2 Phase 2/3 Clinical Developments
The total number of activated study sites has reached 30 hospitals during the first quarter of 2025 for the Company’s Phase 2/3 AIS trial (the ReMEDy2 trial – NCT065216). The majority of these sites are operating under version 5.0 of the study protocol, the latest version, which expanded the pool of eligible AIS participants. While the Company has noted an increase in enrollment in the first part of 2025, with delays in site activation during 2024, the transition to version 5.0 of the protocol and slower than expected enrollment, the Company anticipates the interim analysis for sample size re-estimation on the first 200 participants in the first half of 2026; the Company notes this timing is based upon anticipated increased enrollment.
DiaMedica further reports that its data safety monitoring board (DSMB) completed its scheduled safety review of the new intravenous dosing rates implemented upon resumption of the ReMEDy2 trial. Based upon that review, the DSMB concluded that the ReMEDy2 trial should continue without modification. This pre-specified assessment was based on a comprehensive review of safety data from the first twenty (N=20) enrolled participants and no significant safety concerns were identified.
Daniel J. O’Connor Appointed to the Board
Mr. O’Connor was appointed to DiaMedica’s Board of Directors in February 2025. Most recently Mr. O’Connor served as CEO of Ambrx, where he engineered a turnaround of the company resulting in a
Financial Results Highlights for the Year Ended December 31, 2024
-
Cash Position and Runway – Cash, cash equivalents, and short-term investments were
as of December 31, 2024, compared to$44.1 million as of December 31, 2023. Based on its current plans, the Company anticipates its current cash, cash equivalents, and short-term investments will enable the Company to fund its planned clinical studies and support corporate operations into the third quarter of 2026.$52.9 million -
Cash Flows - Net cash used in operating activities for the year ended December 31, 2024 was
compared to$22.1 million for the year ended December 31, 2023. The increase in cash used in operating activities resulted primarily from the combination of increased net loss and the advance of deposit funds to vendors supporting the Company’s ReMEDy2 clinical trial during 2024.$18.7 million -
Research and Development (R&D) – R&D expenses were
for the year ended December 31, 2024, compared to$19.1 million for the year ended December 31, 2023. The increase was due primarily to cost increases resulting from the continuation of the ReMEDy2 clinical trial, the expansion of the clinical team, and increased manufacturing development activity. Partially offsetting this increase were cost reductions related to completion of prior clinical and non-clinical work in 2023. DiaMedica expects its R&D expenses to increase moderately relative to recent prior periods as the Company expands its ReMEDy2 trial globally and continues site activation and enrollment and expands its DM199 clinical development program into preeclampsia.$13.1 million -
General and Administrative (G&A) – G&A expenses were
for the year ended December 31, 2024, down from$7.6 million for the year ended December 31, 2023. The decrease resulted primarily from the combination of decreased legal fees and reductions in directors’ and officers’ liability insurance premiums.$8.2 million -
Net Loss - Net loss was
, or$24.4 million loss per share, for the year ended December 31, 2024, compared to$0.60 , or$19.4 million loss per share, for the year ended December 31, 2023.$0.60
Conference Call and Webcast Information
DiaMedica Management will host a conference call and webcast to discuss its business update and full year 2024 financial results on Tuesday, March 18, 2025, at 8:00 AM Eastern Time / 7:00 AM Central Time:
Date: |
Tuesday, March 18, 2025 |
Time: |
7:00 AM CDT / 8:00 AM EDT |
Web access: |
|
Dial In: |
(800) 836-8184 |
Conference ID: |
50034 |
Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for playback on DiaMedica’s website, under investor relations - events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until March 25, 2025, by dialing (888) 660-6345 (US Toll Free) and entering the replay passcode: 50034#.
About the Phase 2 Trial of DM199 for Preeclampsia
Preeclampsia (PE) is a serious pregnancy disorder that typically develops after the 20th week of gestation, characterized by high blood pressure and damage to organ systems, often the kidneys and liver. Affecting up to
About the Phase 2/3 ReMEDy2 Trial of DM199 for Acute Ischemic Stroke
The ReMEDy2 trial is an adaptive design, randomized, double-blind, placebo-controlled trial studying the use of the Company’s product candidate, DM199, to treat acute ischemic stroke patients. The trial is intended to enroll approximately 300 patients at up to 100 sites globally. The final sample size will be determined based upon the results of an interim analysis of 200 participants, and, if not stopped for futility, may range between 300 and 728 patients, according to a pre-determined statistical plan. Patients enrolled in the trial will be treated for three weeks with either DM199 or placebo, beginning within 24 hours of the onset of AIS symptoms, with the final follow-up at 90 days. The trial excludes patients who received mechanical thrombectomy (MT) or participants with large vessel occlusions in the intracranial carotid artery or the M1 segment for the middle cerebral, vertebral or basilary arteries or those that are otherwise eligible for MT. Participants treated with tissue plasminogen activator (tPA) or tenecteplase (TNK), (thrombolytic agents) intended to dissolve blood clots, are eligible for participation if they continue to experience a persistent neurological deficit after receiving thrombolytic treatment and meet all other trial criteria. DiaMedica believes that the ReMEDy2 trial has the potential to serve as a pivotal registration study of DM199 in this patient population.
About DM199
DM199 (rinvecalinase alfa) is a recombinant form of human tissue kallikrein-1 (rhKLK1) in clinical development for acute ischemic stroke and preeclampsia. KLK1 is a serine protease enzyme that plays an important role in the regulation of diverse physiological processes via a molecular mechanism that increases production of nitric oxide, prostacyclin and endothelium-derived hyperpolarizing factors. In the case of AIS, DM199 is intended to enhance blood flow and boost neuronal survival in the ischemic penumbra by dilating arterioles surrounding the site of the vascular occlusion and inhibition of apoptosis (neuronal cell death) while also facilitating neuronal remodeling through the promotion of angiogenesis. In preeclampsia, DM199 is intended to lower blood pressure, enhance endothelial health and improve perfusion to maternal organs and the placenta.
About DiaMedica Therapeutics Inc.
DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company committed to improving the lives of people suffering from preeclampsia and acute ischemic stroke. DiaMedica’s lead candidate, DM199, is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality in
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the
DiaMedica Therapeutics Inc. |
|||||||
Condensed Consolidated Statements of Operations and Comprehensive Loss |
|||||||
(In thousands, except share and per share amounts) |
|||||||
|
|
|
Year Ended December 31, |
||||
|
|
|
2024 |
|
2023 |
||
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
19,057 |
|
$ |
13,110 |
|
General and administrative |
|
|
7,624 |
|
|
8,157 |
|
Total operating expenses |
|
|
26,681 |
|
|
21,267 |
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(26,681) |
|
|
(21,267) |
|
|
|
|
|
|
|
|
Other income: |
|
|
|
|
|
|
|
|
Other income, net |
|
|
2,267 |
|
|
1,929 |
|
Total other income, net |
|
|
2,267 |
|
|
1,929 |
|
|
|
|
|
|
|
|
Loss before income tax expense |
|
|
(24,414) |
|
|
(19,338) |
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
|
(30) |
|
|
(43) |
|
|
|
|
|
|
|
|
Net loss |
|
|
(24,444) |
|
|
(19,381) |
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss) |
|
|
|
|
|
|
|
|
Unrealized gain on marketable securities |
|
|
17 |
|
|
80 |
|
|
|
|
|
|
|
|
Net loss and comprehensive loss |
|
$ |
(24,427) |
|
$ |
(19,301) |
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.60) |
|
$ |
(0.60) |
|
|
Weighted average shares outstanding – basic and diluted |
|
|
40,404,681 |
|
|
32,566,723 |
|
|
|
|
|
|
DiaMedica Therapeutics Inc. |
|||||||
Condensed Consolidated Balance Sheets |
|||||||
(In thousands, except share amounts) |
|||||||
|
|
|
December 31, 2024 |
|
December 31, 2023 |
||
|
|
|
|
|
|
||
ASSETS |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
3,025 |
|
$ |
4,543 |
|
Marketable securities |
|
|
41,122 |
|
|
48,352 |
|
Amounts receivable |
|
|
236 |
|
|
369 |
|
Prepaid expenses and other assets |
|
|
227 |
|
|
411 |
|
Total current assets |
|
|
44,610 |
|
|
53,675 |
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
Deposits |
|
|
1,308 |
|
|
— |
|
Operating lease right-of-use asset |
|
|
279 |
|
|
354 |
|
Property and equipment, net |
|
|
148 |
|
|
131 |
|
Total non-current assets |
|
|
1,735 |
|
|
485 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
46,345 |
|
$ |
54,160 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND EQUITY |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
940 |
|
$ |
926 |
|
Accrued liabilities |
|
|
4,347 |
|
|
1,777 |
|
Finance lease obligation |
|
|
13 |
|
|
3 |
|
Operating lease obligation |
|
|
90 |
|
|
80 |
|
Total current liabilities |
|
|
5,390 |
|
|
2,786 |
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
Finance lease obligation, non-current |
|
|
12 |
|
|
1 |
|
Operating lease obligation, non-current |
|
|
225 |
|
|
316 |
|
Total non-current liabilities |
|
|
237 |
|
|
317 |
|
|
|
|
|
|
|
|
Shareholders’ equity: |
|
|
|
|
|
|
|
|
Common shares, no par value; unlimited authorized; 42,818,660 and 37,958,000 shares issued and outstanding, as of December 31, 2024 and 2023, respectively |
|
|
— |
|
|
— |
|
Paid-in capital |
|
|
180,697 |
|
|
166,609 |
|
Accumulated other comprehensive income |
|
|
23 |
|
|
6 |
|
Accumulated deficit |
|
|
(140,002) |
|
|
(115,558) |
|
Total shareholders’ equity |
|
|
40,718 |
|
|
51,057 |
Total liabilities and shareholders’ equity |
|
$ |
46,345 |
|
$ |
54,160 |
|
|
|
|
|
|
|
|
|
DiaMedica Therapeutics Inc. |
||||||
Condensed Consolidated Statements of Cash Flows |
||||||
(In thousands) |
||||||
|
|
Year Ended December 31, |
||||
|
|
2024 |
|
2023 |
||
Cash flows from operating activities: |
|
|
|
|
|
|
Net loss |
|
$ |
(24,444) |
|
$ |
(19,381) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
Share-based compensation |
|
|
2,085 |
|
|
1,683 |
Amortization of discounts on marketable securities |
|
|
(1,343) |
|
|
(1,223) |
Non-cash lease expense |
|
|
75 |
|
|
70 |
Depreciation |
|
|
39 |
|
|
30 |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
Amounts receivable |
|
|
133 |
|
|
(287) |
Prepaid expenses and other assets |
|
|
184 |
|
|
(160) |
Deposits |
|
|
(1,308) |
|
|
— |
Accounts payable |
|
|
14 |
|
|
192 |
Accrued liabilities |
|
|
2,489 |
|
|
348 |
Net cash used in operating activities |
|
|
(22,076) |
|
|
(18,728) |
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
Purchase of marketable securities |
|
|
(50,411) |
|
|
(69,410) |
Maturities of marketable securities |
|
|
59,000 |
|
|
51,135 |
Purchase of property and equipment |
|
|
(25) |
|
|
(24) |
Net cash provided by (used in) investing activities |
|
|
8,564 |
|
|
(18,299) |
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
Proceeds from issuance of common shares, net of offering costs |
|
|
11,747 |
|
|
36,848 |
Proceeds from the exercise of stock options |
|
|
256 |
|
|
— |
Principal payments on finance lease obligations |
|
|
(9) |
|
|
(6) |
Net cash provided by financing activities |
|
|
11,994 |
|
|
36,842 |
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents |
|
|
(1,518) |
|
|
(185) |
Cash and cash equivalents at beginning of period |
|
|
4,543 |
|
|
4,728 |
Cash and cash equivalents at end of period |
|
$ |
3,025 |
|
$ |
4,543 |
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
Assets acquired under financing lease |
|
$ |
30 |
|
$ |
— |
Cash paid for income taxes |
|
$ |
26 |
|
$ |
33 |
|
|
|
|
|
|
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20250317880582/en/
Scott Kellen
Chief Financial Officer
Phone: (763) 496-5118
skellen@diamedica.com
For Investor Inquiries:
Mike Moyer
Managing Director, LifeSci Advisors, LLC
Phone: (617) 308-4306
mmoyer@lifesciadvisors.com
Source: DiaMedica Therapeutics Inc.