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DiaMedica Therapeutics Provides a Business Update and Announces Third Quarter 2024 Financial Results

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DiaMedica Therapeutics (DMAC) provided Q3 2024 updates on its clinical programs. The company implemented changes to its ReMEDy2 Acute Ischemic Stroke Phase 2/3 trial, expanding the trial population to include thrombolytic non-responders and increasing interim analysis sample size to 200 subjects. Top-line interim results are now expected in Q4 2025. The company's Preeclampsia Phase 2 trial received regulatory approval and dosed its first patient. Financial highlights include cash position of $50.2M as of September 30, 2024, R&D expenses increased to $5.0M in Q3, and G&A expenses remained stable at $1.9M. Cash runway extends into Q3 2026.

DiaMedica Therapeutics (DMAC) ha fornito aggiornamenti sul Q3 2024 riguardanti i suoi programmi clinici. L'azienda ha apportato modifiche al suo trial di fase 2/3 ReMEDy2 per l'ictus ischemico acuto, ampliando la popolazione del trial per includere i soggetti non rispondenti ai trombolitici e aumentando la dimensione del campione per l'analisi intermedia a 200 soggetti. I risultati preliminari sono ora attesi nel Q4 2025. Il trial di fase 2 sulla preeclampsia dell'azienda ha ricevuto approvazione regolatoria e ha somministrato il primo trattamento. I risultati finanziari evidenziano una posizione di cassa di $50,2 milioni al 30 settembre 2024, spese per ricerca e sviluppo aumentate a $5 milioni nel Q3, e spese generali e amministrative rimaste stabili a $1,9 milioni. La disponibilità di cassa si estende fino al Q3 2026.

DiaMedica Therapeutics (DMAC) proporcionó actualizaciones del Q3 2024 sobre sus programas clínicos. La compañía implementó cambios en su ensayo de fase 2/3 ReMEDy2 para accidente cerebrovascular isquémico agudo, expandiendo la población del ensayo para incluir no respondedores a trombolíticos y aumentando el tamaño de la muestra para el análisis intermedio a 200 sujetos. Los resultados preliminares ahora se esperan en el Q4 2025. El ensayo de fase 2 sobre preeclampsia de la compañía recibió aprobación regulatoria y dosificó a su primer paciente. Los aspectos financieros incluyen una posición de efectivo de $50,2 millones al 30 de septiembre de 2024, gastos de I+D aumentados a $5 millones en el Q3, y gastos generales y administrativos estables en $1,9 millones. La disponibilidad de efectivo se extiende hasta el Q3 2026.

DiaMedica Therapeutics (DMAC)는 Q3 2024의 임상 프로그램 업데이트를 제공했습니다. 회사는 급성 허혈성 뇌졸중에 대한 ReMEDy2 2/3상 시험을 변경하여 시험 대상을 혈전 용해제에 반응하지 않는 환자로 확대하고, 중간 분석 샘플 크기를 200명으로 증가시켰습니다. 주요 중간 결과는 이제 Q4 2025년에 예상됩니다. 회사의 전자혈압증 시험이 규제 승인을 받고 첫 번째 환자에게 투약되었습니다. 재무 하이라이트에는 2024년 9월 30일 현재 현금 위치가 $50.2M인 점, Q3의 연구개발(R&D) 비용이 $5.0M으로 증가한 점, 일반 및 관리(G&A) 비용이 $1.9M으로 안정적이었던 점이 포함됩니다. 현금 운영 자금은 Q3 2026년까지 연장됩니다.

DiaMedica Therapeutics (DMAC) a fourni des mises à jour pour le Q3 2024 concernant ses programmes cliniques. La société a apporté des modifications à son essai de phase 2/3 ReMEDy2 sur l'accident vasculaire cérébral ischémique aigu, en élargissant la population de l'essai pour inclure les non-répondeurs aux thrombolytiques et en augmentant la taille de l'échantillon pour l'analyse intermédiaire à 200 sujets. Les résultats préliminaires sont désormais attendus au Q4 2025. L'essai de phase 2 sur la prééclampsie de la société a reçu l'approbation réglementaire et a administré son premier traitement. Les points forts financiers incluent une position de trésorerie de 50,2 millions de dollars au 30 septembre 2024, des dépenses de R&D augmentées à 5,0 millions de dollars au Q3, et des dépenses générales et administratives restées stables à 1,9 million de dollars. La période de trésorerie s'étend jusqu'au Q3 2026.

DiaMedica Therapeutics (DMAC) hat im Q3 2024 Updates zu seinen klinischen Programmen bereitgestellt. Das Unternehmen hat Änderungen an seiner ReMEDy2-Studie der Phasen 2/3 für akuten ischämischen Schlaganfall vorgenommen, wobei die Studienpopulation erweitert wurde, um thrombolytische Nicht-Responder einzuschließen, und die Stichprobengröße für die Zwischenanalyse auf 200 Probanden erhöht wurde. Die vorläufigen Ergebnisse werden nun im Q4 2025 erwartet. Die Phase-2-Studie zu Präeklampsie des Unternehmens erhielt die behördliche Genehmigung und hat ihren ersten Patienten behandelt. Finanzielle Höhepunkte beinhalten eine Liquiditätsposition von 50,2 Millionen USD zum 30. September 2024, F&E-Ausgaben von 5,0 Millionen USD im Q3 und stabile allgemeine und Verwaltungskosten in Höhe von 1,9 Millionen USD. Die finanzielle Laufzeit erstreckt sich bis ins Q3 2026.

Positive
  • Strong cash position of $50.2M with runway into Q3 2026
  • Received regulatory approval and initiated Preeclampsia Phase 2 trial
  • Expanded ReMEDy2 trial population potentially accelerating enrollment
  • Protocol changes may reduce total trial size and costs
Negative
  • R&D expenses increased to $5.0M in Q3 2024 from $3.3M in Q3 2023
  • Net cash used in operations increased to $15.6M from $14.9M YoY
  • Delayed interim results timeline from Summer 2025 to Q4 2025

Insights

The Q3 2024 financial update reveals a stable financial position with $50.2 million in cash and investments, providing runway into Q3 2026. R&D expenses increased to $5.0 million from $3.3 million year-over-year, reflecting expanded clinical trial activities. The company maintains strong working capital of $46.5 million, though slightly down from year-end 2023. The increased cash burn rate, with net operating cash use of $15.6 million for the first nine months, indicates accelerating clinical development, particularly in the ReMEDy2 trial. Protocol modifications could potentially reduce total trial costs through a more efficient interim analysis design.

The expansion of the ReMEDy2 trial to include thrombolytic non-responders is strategically significant. This modification could accelerate enrollment while targeting patients who showed strong treatment response in previous trials. The increase in interim analysis sample size to 200 subjects, though delaying results to Q4 2025, may ultimately reduce the total required participants. The initiation of the preeclampsia Phase 2 trial adds a second potential indication, with early results expected in H1 2025. These developments demonstrate pipeline progression while maintaining scientific rigor.

Conference Call and Webcast Thursday November 14 at 8:00 AM Eastern Time / 7:00 AM Central Time

  • Implemented Updates to AIS Program Intended to Enhance Probability of Trial Success and Expedite Study Completion, with Potential for a Reduced Study Size
  • Preeclampsia Phase 2 Trial Received Regulatory Approval and First Patient Dosed
  • Cash Runway Into Q3 2026

MINNEAPOLIS--(BUSINESS WIRE)-- DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for severe ischemic diseases, today provided a business update and financial results for the quarter ended September 30, 2024. Management will host a conference call Thursday, November 14, 2024, at 8:00 AM Eastern Time / 7:00 AM Central Time to discuss its business update and third quarter 2024 financial results.

Updates to ReMEDy2 Acute Ischemic Stroke (AIS) Phase 2/3 Protocol and Statistical Analysis Plan

Following in-depth discussions of the ReMEDy2 trial with current and prospective investigators, stroke experts and its scientific advisory board, the Company has made certain additional updates to the protocol intended to enhance the probability of success for the trial, principally through two modifications: broadening the trial population to include patients not responding to thrombolytic treatment (tissue plasminogen activator (tPA) or tenecteplase (TNK)) and increasing the sample size of the planned interim analysis. These changes were submitted the United States Food and Drug Administration (FDA) on August 30, 2024, and as no FDA comments have been received to-date, the Company is proceeding with implementation..

The first modification of expanding the trial population will capture patients expected to demonstrate a strong treatment response with a low placebo response, potentially enhancing the primary outcome measure for the ReMEDy2 trial. These patients are considered “non-responders” if they receive thrombolytic therapy but retain a persistent neurologic deficit, meaning that their stroke symptoms do not improve, six or more hours following administration of the thrombolytic. In the Company’s prior ReMEDy1 Phase 2 stroke trial, the subgroup of patients who received tPA (n=20) prior to enrollment showed the highest response rate of any group, with these patients receiving DM199 or placebo an average of 13.5 hours post-tPA administration, indicating that the participants did have a persistent neurological deficit prior to randomization. The Company further notes that including these patients has the potential to significantly accelerate enrollment.

The second modification follows additional statistical modeling of the adaptive design study whereby the interim analysis will be conducted when 200 subjects are treated instead of the previously proposed sample size of 144 subjects. The incremental increase in sample size is intended to increase the precision of the algorithm used to determine the final overall sample size, which we expect will reduce the total number of participants required for the study, thereby reducing the overall trial timeline and trial cost. DiaMedica plans to submit an amended statistical analysis plan (SAP) to the FDA for confirmatory comments.

Together, these protocol and SAP changes are intended to increase the probability of success for the ReMEDy2 trial and expedite overall completion of the study, with potential for a reduced sample size and cost savings.

ReMEDy2 Phase 2/3 Clinical Update

Progress continues with the ReMEDy2 trial site activation activities. The majority of the Company’s priority research sites in the United States have been activated. These sites are anticipated to be top enrollment centers for the ReMEDy2 trial and are expected to enroll a disproportionately large share of participants in the trial. DiaMedica recently received approval from Health Canada to conduct the ReMEDy2 trial in Canada and is on track to commence site activations in Canada by the end of the year.

With the adoption of an increased sample size for the interim analysis, the Company now anticipates top line interim results in Q4 2025 compared to the Company’s previous guidance of Summer 2025. Patient recruitment will continue while the first 200 participants complete their participation in the trial and the interim analysis is conducted.

"The inclusion of thrombolytic non-responders significantly expands the pool of eligible patients with potential for observing increased treatment responses," stated Dr. Lorianne Masuoka, DiaMedica’s Chief Medical Officer. "As we near the completion of activating our high-volume centers, this is expected to catalyze further enrollment momentum."

Preeclampsia Phase 2 Investigator-Sponsored Trial

DM199 is being developed as a disease-modifying treatment to safely extend gestation and improve fetal and maternal outcomes in preeclampsia (PE). DM199’s mechanism of action has the potential to lower blood pressure, enhance endothelial health and improve perfusion to maternal organs and the placenta. On October 9, 2024, DiaMedica announced the receipt of regulatory approval from the South African Health Products Regulatory Authority (SAHPRA) to initiate an investigator-sponsored trial (IST) of DM199 in PE. As reported earlier today, the first patient has been enrolled in the Part 1A dose escalation portion of the Phase 2 study. Top line results from Part 1A are anticipated in the first half of 2025.

The Phase 2 IST is an open-label, single center, single-arm, safety and pharmacodynamic, proof-of-concept study of DM199 for the treatment of PE conducted at the Tygerberg Hospital, Cape Town, South Africa. Up to 90 women with PE, and potentially an additional 30 subjects with fetal growth restriction, may be evaluated. Part 1 of the PE study is recruiting women planned for delivery within 72 hours and Part 2 will recruit women in the expectant management setting. Key outcomes from Part 1 are safety, tolerability, identifying whether DM199 crosses the placental barrier and two efficacy signals of interest to DiaMedica: (1) change in maternal systolic blood pressure (SBP) after infusion and (2) improved baseline uterine artery blood flow.

A replay of the Company’s July 29, 2024 Preeclampsia Key Opinion Leader (KOL) Event continues to be available on the DiaMedica website click here.

In conjunction with the webinar, DiaMedica released a white paper titled “The Potential of DM199 to Treat Preeclampsia”. The white paper can be downloaded from the Literature & Publications section of DiaMedica.com or click here.

Balance Sheet and Cash Flow

DiaMedica reported total cash, cash equivalents and investments of $50.2 million, current liabilities of $4.3 million and working capital of $46.5 million as of September 30, 2024, compared to total cash, cash equivalents and investments of $52.9 million, current liabilities of $2.8 million and working capital of $50.9 million as of December 31, 2023. The decreases in combined cash, cash equivalents and marketable securities and in working capital are due to the net cash used in operating activities partially offset by the net proceeds received from DiaMedica’s June 2024 private placement.

Net cash used in operating activities for the nine months ended September 30, 2024 was $15.6 million compared to $14.9 million for the nine months ended September 30, 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 ReMEDy2 clinical trial during, the current year period, partially offset by changes in operating assets and liabilities during the current year period.

Financial Results

Research and development (R&D) expenses increased to $5.0 million for the three months ended September 30, 2024, up from $3.3 million for the three months ended September 30, 2023. R&D expenses increased to $12.6 million for the nine months ended September 30, 2024, up from $9.4 million for the nine months ended September 30, 2023. These increases are due primarily to increased costs resulting from the continuation of the ReMEDy2 clinical trial, the expansion of the Company’s clinical team and increased manufacturing development activity. These increases were partially offset by decreased costs related to clinical trial work completed in 2023, including the Phase 1C and REDUX trials, and the completion in 2023 of in-use study work performed to address the prior clinical hold on the ReMEDy2 trial. DiaMedica expects R&D expenses to increase moderately relative to recent prior periods as it globally expands the ReMEDy2 trial site activations and participant enrollments continue.

General and administrative (G&A) expenses were $1.9 million for each of the three month periods ended September 30, 2024 and 2023. G&A expenses were $5.7 million for the nine months ended September 30, 2024, down from $6.0 million for the nine months ended September 30, 2023. The decrease for the nine-month comparison resulted from the combination of reductions in the cost of directors and officers liability insurance premiums and decreased legal fees incurred in connection with DiaMedica’s lawsuit against PRA Netherlands and was partially offset by increased personnel costs incurred in conjunction with expanding the team and increased non-cash share-based compensation costs. DiaMedica expects G&A expenses to remain steady as compared to recent prior periods.

Other income, net, was $616 thousand and $1.8 million for the three and nine months ended September 30, 2024, respectively, compared to $693 thousand and $1.2 million for the three and nine months ended September 30, 2023, respectively. The nine-month comparison increase was driven by increased interest income recognized during the current year period related to a higher average marketable securities balance compared to the prior year period.

Conference Call and Webcast Information

DiaMedica Management will host a conference call and webcast to discuss its business update and third quarter 2024 financial results on Thursday, November 14, 2024 at 8:00 AM Eastern Time / 7:00 AM Central Time:

Date:

     

Thursday, November 14, 2024

Time:

     

8:00 AM ET / 7:00 AM CT

Web access:

     

https://app.webinar.net/8B2w698qkyb

Dial In:

     

(646) 357-8785

Conference ID:

     

28056

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 November 18, 2024, by dialing (888) 660-6345 (US Toll Free) and entering the replay passcode: 28056#.

About the Acute Ischemic Stroke Phase 2/3 ReMEDy2 Trial

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 350 patients at up to 100 sites globally. 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 proposed trial has the potential to serve as a pivotal registration study of DM199 in this patient population.

About the Preeclampsia Phase 2 Trial

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 8% of pregnancies worldwide, preeclampsia can pose significant risks to both the mother and baby, including risk of stroke, placental abruption, progression to eclampsia, premature delivery, and death. This Phase 2 open-label, single center, single-arm, safety and pharmacodynamic, proof-of-concept, investigator-sponsored study of DM199 in treating preeclampsia is being conducted at the Tygerberg Hospital, Cape Town, South Africa (SA), under the direction of Catherine Cluver, MD, PhD, Professor of Maternal/Fetal Medicine, Stellenbosch University, Stellenbosch, SA, in collaboration with DiaMedica. This trial will enroll up to 90 women with preeclampsia and potentially 30 subjects with fetal growth restriction. Dosing commenced in the fourth quarter of 2024. Part 1A top line study results are anticipated in the first half of 2025 and are intended to demonstrate whether DM199 is safe and lowers maternal blood pressure. Additionally, patients with early onset PE will be evaluated for improvements in uterine artery dilation, a sign that DM199 is a potentially disease modifying therapy.

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 serious ischemic diseases with a focus on acute ischemic stroke and preeclampsia. DiaMedica’s lead candidate DM199 is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality in Asia for the treatment of acute ischemic stroke, preeclampsia and other vascular diseases. For more information visit the Company’s website at www.diamedica.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and forward-looking information that are based on the beliefs of management and reflect management’s current expectations. When used in this press release, the words “anticipates,” “believes,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” or “will,” the negative of these words or such variations thereon or comparable terminology, and the use of future dates are intended to identify forward-looking statements and information. The forward-looking statements and information in this press release include statements regarding the Company’s expectations regarding the effect of the ReMEDy2 protocol and statistical analysis plan changes and whether they will increase the probability of success for the trial, expedite overall study completion, reduce the sample size and save costs; the timing for additional ReMEDy2 trial site activations and interim enrollment; timing for top line results from Part 1A of the preeclampsia Phase 2 investigator-sponsored trial; anticipated clinical benefits and success of DM199; future operating expenses and cash runway into third quarter of 2026. Such statements and information reflect management’s current view and DiaMedica undertakes no obligation to update or revise any of these statements or information. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Applicable risks and uncertainties include, among others, risks and uncertainties relating to the timing of ReMEDy2 trial site activations and enrollment, regulatory applications and related filing and approval timelines; the possibility of additional future adverse events associated with or unfavorable results from the ReMEDy2 trial; risks and uncertainties relating to the clinical expansion into preeclampsia and the DM199 Phase 2 trial for preeclampsia, including timing of results; the possibility of unfavorable results from DiaMedica’s ongoing or future clinical trials of DM199; the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; DiaMedica’s plans to develop, obtain regulatory approval for and commercialize its DM199 product candidate for the treatment of acute ischemic stroke and preeclampsia and its expectations regarding the benefits of DM199; DiaMedica’s ability to conduct successful clinical testing of DM199 and within its anticipated parameters, site activations, enrollment numbers, costs and timeframes; the adaptive design of the ReMEDy2 trial and the possibility that the targeted enrollment and other aspects of the trial could change depending upon certain factors, including additional input from the FDA and the blinded interim analysis; the perceived benefits of DM199 over existing treatment options; the potential direct or indirect impact of COVID-19, hospital and medical facility staffing shortages, and worldwide global supply chain shortages on DiaMedica’s business and clinical trials, including its ability to meet its site activation and enrollment goals; DiaMedica’s reliance on collaboration with third parties to conduct clinical trials; DiaMedica’s ability to continue to obtain funding for its operations, including funding necessary to complete current and planned clinical trials and obtain regulatory approvals for DM199 for acute ischemic stroke and preeclampsia, and the risks identified under the heading “Risk Factors” in DiaMedica’s annual report on Form 10-K for the fiscal year ended December 31, 2023 and subsequent reports filed with the U.S. Securities and Exchange Commission, including its most recent quarterly report on Form 10-Q for the quarterly period ended September 30, 2024. The forward-looking information contained in this press release represents the expectations of DiaMedica as of the date of this press release and, accordingly, is subject to change after such date. Readers should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While DiaMedica may elect to, it does not undertake to update this information at any particular time except as required in accordance with applicable laws.

 
 
 

DiaMedica Therapeutics Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(Unaudited) 

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

2024

 

2023

 

2024

 

2023

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Research and development

$

4,983

 

 

$

3,272

 

 

$

12,587

 

 

$

9,433

 

General and administrative

 

1,900

 

 

 

1,885

 

 

 

5,675

 

 

 

5,986

 

Operating loss

 

(6,883

)

 

 

(5,157

)

 

 

(18,262

)

 

 

(15,419

)

 

 

 

 

 

 

 

 

 

 

 

 

Other income:

 

 

 

 

 

 

 

 

 

 

 

Other income, net

 

616

 

 

 

693

 

 

 

1,739

 

 

 

1,220

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss before income tax expense

 

(6,267

)

 

 

(4,464

)

 

 

(16,523

)

 

 

(14,199

)

 

 

 

 

 

 

 

 

 

 

 

 

Income tax expense

 

(7

)

 

 

(7

)

 

 

(21

)

 

 

(21

)

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

(6,274

)

 

 

(4,471

)

 

 

(16,544

)

 

 

(14,220

)

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive income (loss)

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on marketable securities

 

132

 

 

 

(64

)

 

 

75

 

 

 

(53

)

 

 

 

 

 

 

 

 

 

 

 

 

Net loss and comprehensive loss

$

(6,142

)

 

$

(4,535

)

 

$

(16,469

)

 

$

(14,273

)

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share

$

(0.15

)

 

$

(0.12

)

 

$

(0.42

)

 

$

(0.46

)

Weighted average shares outstanding – basic and diluted

 

42,751,577

 

 

 

37,949,422

 

 

 

39,604,179

 

 

 

30,751,329

 

 
 
 
 

DiaMedica Therapeutics Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share amounts) 

 

 

September 30,

2024

 

December 31,

2023

 

(unaudited)

 

 

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

4,134

 

 

$

4,543

 

Marketable securities

 

 

46,063

 

 

 

48,352

 

Amounts receivable

 

 

290

 

 

 

411

 

Prepaid expenses and other assets

 

 

280

 

 

 

369

 

Total current assets

 

 

50,767

 

 

 

53,675

 

 

 

 

 

Non-current assets:

 

 

 

 

Deposits

 

 

1,308

 

 

 

 

Operating lease right-of-use asset, net

 

 

298

 

 

 

354

 

Property and equipment, net

 

 

151

 

 

 

131

 

Total non-current assets

 

 

1,757

 

 

 

485

 

 

 

 

 

Total assets

 

$

52,524

 

 

$

54,160

 

 

 

 

 

 

 

LIABILITIES AND EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,171

 

 

$

926

 

Accrued liabilities

 

 

3,024

 

 

 

1,777

 

Operating lease obligation

 

 

88

 

 

 

80

 

Finance lease obligation

 

 

14

 

 

 

3

 

Total current liabilities

 

 

4,297

 

 

 

2,786

 

 

 

 

 

 

 

Non-current liabilities:

 

 

 

 

 

 

Operating lease obligation

 

 

249

 

 

 

316

 

Finance lease obligation

 

 

14

 

 

 

1

 

Total non-current liabilities

 

 

263

 

 

 

317

 

 

 

 

 

 

 

Shareholders’ equity:

 

 

 

 

 

 

Common shares, no par value; unlimited authorized; 42,766,497 and 37,958,000 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively

 

 

 

 

 

 

Paid-in capital

 

 

179,985

 

 

 

166,609

 

Accumulated other comprehensive income

 

 

81

 

 

 

6

 

Accumulated deficit

 

 

(132,102

)

 

 

(115,558

)

Total shareholders’ equity

 

 

47,964

 

 

 

51,057

 

Total liabilities and shareholders’ equity

 

$

56,791

 

 

$

54,160

 

 
 
 
 

DiaMedica Therapeutics Inc.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited) 

 

 

 

Nine Months Ended

September 30,

 

 

2024

 

2023

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(16,544

)

 

$

(14,220

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

Share-based compensation

 

 

1,496

 

 

 

1,227

 

Amortization of discount on marketable securities

 

 

(1,013

)

 

 

(856

)

Non-cash lease expense

 

 

56

 

 

 

52

 

Depreciation

 

 

28

 

 

 

22

 

Changes in operating assets and liabilities:

 

 

 

 

Amounts receivable

 

 

79

 

 

 

(228

)

Prepaid expenses and other assets

 

 

131

 

 

 

(860

)

Deposits

 

 

(1,308

)

 

 

 

Accounts payable

 

 

245

 

 

 

129

 

Accrued liabilities

 

 

1,188

 

 

 

(182

)

Net cash used in operating activities

 

 

(15,642

)

 

 

(14,916

)

 

 

 

 

Cash flows from investing activities:

 

 

 

 

Purchase of marketable securities

 

 

(39,623

)

 

 

(64,537

)

Maturities of marketable securities

 

 

43,000

 

 

 

40,135

 

Purchases of property and equipment

 

 

(18

)

 

 

(21

)

Net cash provided by (used in) investing activities

 

 

3,359

 

 

 

(24,423

)

 

 

 

 

Cash flows from financing activities:

 

 

 

 

Proceeds from issuance of common shares, net of offering costs

 

 

11,747

 

 

 

36,848

 

Proceed from the exercise of common stock options

 

 

133

 

 

 

 

Principal payments on finance lease obligation

 

 

(6

)

 

 

(5

)

Net cash provided by financing activities

 

 

11,874

 

 

 

36,843

 

 

 

 

 

Net decrease in cash and cash equivalents

 

 

(409

)

 

 

(2,496

)

Cash and cash equivalents at beginning of period

 

 

4,543

 

 

 

4,728

 

Cash and cash equivalents at end of period

 

$

4,134

 

 

$

2,232

 

 

 

 

 

 

 

Supplemental disclosure of non-cash transactions:

 

 

 

 

 

 

Assets acquired under financing lease

 

$

30

 

 

$

 

Cash paid for income taxes

 

$

20

 

 

$

26

 

 
 

 

Scott Kellen

Chief Financial Officer

Phone: (763) 496-5118

skellen@diamedica.com

For Investor Inquiries:

Mike Moyer

Managing Director, LifeSci Advisors, LLC

mmoyer@lifesciadvisors.com

Source: DiaMedica Therapeutics Inc.

FAQ

What changes did DiaMedica (DMAC) make to its ReMEDy2 trial protocol in Q3 2024?

DMAC expanded the trial population to include thrombolytic non-responders and increased the interim analysis sample size to 200 subjects, aiming to enhance trial success probability and potentially reduce overall study size.

What is DiaMedica's (DMAC) cash position as of September 30, 2024?

DMAC reported $50.2M in total cash, cash equivalents and investments, with working capital of $46.5M and current liabilities of $4.3M.

When does DiaMedica (DMAC) expect top-line interim results for the ReMEDy2 trial?

DMAC expects top-line interim results in Q4 2025, revised from the previous guidance of Summer 2025.

What progress has DiaMedica (DMAC) made in its Preeclampsia trial in Q3 2024?

DMAC received regulatory approval from South African authorities and dosed its first patient in the Phase 2 Preeclampsia trial, with top-line results from Part 1A expected in first half of 2025.

DiaMedica Therapeutics Inc.

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