DMACNasdaqPharmaceutical PreparationsUS GAAP · USD

DiaMedica Therapeutics Inc.

DiaMedica Therapeutics Inc. is a clinical-stage biopharmaceutical company developing DM199 (rinvecalinase alfa), a recombinant form of human tissue kallikrein-1, for preeclampsia and acute ischemic stroke. The company also has an earlier-stage preclinical program, DM300, for severe acute pancreatitis, but its business is centered on advancing DM199 through clinical trials and regulatory review.

Kysy yhtiöstä
Liikevoitto (EBIT)−34,4milj. USD
−28,9 %v/v
Nettotulos−32,8milj. USD
−34,0 %v/v
Vapaa kassavirta−29,1milj. USD
−31,7 %v/v

Tilikausi 2025 · muutos edellisvuodesta

Kehitys 2020–2025

−40−30−20−100milj. USD2020: EBIT −13 milj. USD20202021: EBIT −14 milj. USD20212022: EBIT −14 milj. USD20222023: EBIT −21 milj. USD20232024: EBIT −27 milj. USD20242025: EBIT −34 milj. USD2025−34
LiikevaihtoLiikevoitto (EBIT)

Liiketoiminta

Osuus liikevaihdosta
DM199 clinical programs100 %

Lead recombinant KLK1 candidate being developed for preeclampsia and acute ischemic stroke.

Preclinical pipeline0 %

Early-stage DM300 program targeting severe acute pancreatitis.

Asiakkaat

DiaMedica does not sell commercial products today; its near-term counterparties are clinical investigators, trial sites, regulators, and potential development partners. If DM199 is approved, the end customers would be hospitals, physicians, and patients in maternal health and stroke care, with commercialization likely depending on a partner or licensing arrangement.

Clinical trial investigators and sites

Run the preeclampsia and AIS studies and generate the data needed for regulatory advancement.

Regulatory agencies

FDA and other agencies review pre-IND, IND, and clinical data before approval can progress.

Strategic partners and licensors

May provide funding, development support, or commercialization rights for DM199.

Future hospitals and physicians

Would use DM199 if approved for preeclampsia or acute ischemic stroke treatment.

Strategia

DiaMedica's strategy is to advance DM199 through clinical proof-of-concept and later-stage trials in preeclampsia and acute ischemic stroke. The company is also working to preserve flexibility through partnerships or licensing, since commercialization would require substantial capital and operational scale.

Advance DM199 in preeclampsiaLyhyt aikaväli

Preeclampsia is a new indication with potential clinical differentiation and value creation.

Continue and expand ReMEDy2 in AISLyhyt aikaväli

Stroke remains the core clinical program and a key path to eventual approval.

Preserve financing flexibilityLyhyt aikaväli

The company has no product revenue and depends on external capital to fund R&D.

Build optionality for commercializationKeskipitkä aikaväli

If DM199 succeeds, the company may need a partner to support sales, manufacturing, and distribution.

Maantiede

The company is U.S.-based and its current business is primarily driven by clinical development and regulatory activity rather than product sales. Its ReMEDy2 stroke trial is described as global in scope, and the company is expanding its preeclampsia program through FDA interaction in the United States. Because it has no product revenue, geography mainly affects where trials are run, where regulators are engaged, and where future commercialization could occur.

Riskit

DiaMedica is exposed to classic clinical-stage biotech risks: trial failure, regulatory delay, and financing dependence. Its lead asset must reproduce early signals in later studies, and the company may need to raise capital before any product revenue is available. Government agency staffing or funding disruptions could also slow FDA review and other approvals that the business depends on.

Järjestetty vakavuuden mukaan
MatalaKohtalainenKorkeaMatalaKohtalainenKorkeaVaikutus →Todennäköisyys →Clinical trial failure or non-replication of data1Regulatory delay or adverse FDA feedback2Government agency disruption4
Vaikutus on riskin vakavuus ja todennäköisyys sen toteutumisen todennäköisyys lähivuosina, molemmat arvioitu yhtiön raporttien perusteella. Numerot vastaavat listaa.
  1. Clinical trial failure or non-replication of dataVaikutus: KorkeaTodennäköisyys: Kohtalainen

    DM199 must show consistent efficacy and safety in later trials to support approval.

    Kohdistuu: Preeclampsia and acute ischemic stroke programs

  2. Regulatory delay or adverse FDA feedbackVaikutus: KorkeaTodennäköisyys: Kohtalainen

    The company depends on FDA review to advance from pre-IND/IND into later development.

    Kohdistuu: PE program and broader clinical timeline

  3. Financing and dilution riskVaikutus: Korkea

    The company has no product sales and relies on equity or other external funding.

    Kohdistuu: Operating runway and ownership dilution

  4. Government agency disruptionVaikutus: KeskitasoTodennäköisyys: Kohtalainen

    Reduced staffing or funding at FDA/SEC can delay approvals and normal oversight functions.

    Kohdistuu: Regulatory process timing

  5. Commercialization execution riskVaikutus: Keskitaso

    If approved, DiaMedica may need partners or significant internal buildout for launch.

    KohdistuuMarketingSalesManufacturingDistribution

Kirjanpito

Harkinnanvaraiset erät
Research and development expense recognition

Trial expansion, manufacturing development, and clinical staffing directly affect operating loss.

Vaikutus: Higher R&D spend can materially increase quarterly cash burn.

Stock-based compensation

G&A includes non-cash share-based awards for executives and support staff.

Vaikutus: Affects reported operating expense and dilution analysis.

Marketable securities and interest income

Other income, net is driven mainly by interest earned on invested cash.

Vaikutus: Changes in balances and rates affect non-operating results and liquidity.

Future collaboration or licensing accounting

Any upfront fees, milestones, or royalties would change the revenue profile materially.

Vaikutus: Could introduce revenue recognition judgments once commercialization partnerships exist.

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Päivitetty: 24.9.2026