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DiaMedica Therapeutics Inc. DMAC

Pharmaceutical Preparations · SIC 2834 · Vertical: Pharmaceutical Preparations (SIC 2834)

10.77USD+7.70% · 1 dayClose 04 Nov 2026

DiaMedica Therapeutics develops DM199, a recombinant form of human kallikrein-1, tested for preeclampsia, fetal growth restriction and acute ischemic stroke. The company is still in clinical stage with no approved products, and its net loss of 32.8 million USD in 2025 and cash reserve of 43.5 million USD at June 30, 2026 put funding and study results in focus now.

At the close of 04 Nov 2026, DiaMedica Therapeutics Inc. (DMAC) stock was 10.77 USD (+7.70% on the day), with market capitalisation 580.8 m USD, beta 1.48, 52-week range 5.33–10.77 USD. Latest reported quarter (Q2 2026): net income of -10.1 m USD, diluted EPS -0.19 USD.

Data as of · AI analysis dated · Source: SEC filings and closing prices, computed by olivLaw.

Market cap
580.8 m USD
shares as of 03 Aug 2026
P/E (TTM)
unavailable
Diluted EPS TTM -0.70 · TTM to 31 Dec 2025
E/P (TTM)
-6.50%
TTM to 31 Dec 2025
Dividend yield
unavailable
Beta (2y)
1.48
Volatility (1y) 59%
52-week range
5.3310.77

Price history

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Technical reading

RSI (14)
75.2
overbought (≥ 70)
Bollinger (20, 2)
7.06 – 10.37
above the upper band · %B 1.12 · band width 38.0%
SMA 50 / 200
7.82 / 7.15
uptrend (price > SMA50 > SMA200)
MACD (12, 26, 9)
0.61 / 0.45
MACD above signal

Indicators describe past prices; on their own they do not predict direction. On our history the RSI ≤ 40 filter added no return (see the signals methodology).

Performance

CompanyS&P 500vs S&P 500Vertical median
1 month+27.9%−2.0%+29.9 pp—
3 months+61.6%−2.2%+63.8 pp—
6 months+65.2%+4.3%+60.9 pp—
Year to date+35.3%+10.6%+24.7 pp—
1 year+60.5%+10.5%+50.0 pp+4.2%
3 years+324.0%+73.7%+250.4 pp+4.9%
5 years+131.6%+61.7%+69.9 pp—
Max drawdown (1y)
−43.2%
12 Dec 2025 → 10 Jun 2026
Max drawdown (5y)
−75.4%
08 Nov 2021 → 18 Nov 2022
Compound annual growth (5y)
+18.3%
S&P 500 +10.1%

Price returns, dividends excluded.

Quarterly results

Latest quarter: Q2 2026 · 30 Jun 2026

Revenue
unavailable USD
unavailable YoY
Net income
-10.1 m USD
unavailable YoY
Diluted EPS
-0.19
unavailable YoY
net / operating
unavailable / unavailable

Quarterly statements · USD

Fiscal yearQ3 '24Q4 '24Q1 '25Q2 '25Q3 '25Q4 '25Q1 '26Q2 '26
Research & development5.0 m6.5 m5.7 m5.8 m6.4 m6.7 m8.0 m8.2 m
Operating income-6.9 m-8.4 m-8.1 m-8.0 m-9.0 m-9.2 m-10.5 m-10.5 m
Pre-tax income-6.3 m-7.9 m-7.7 m-7.7 m-8.6 m-8.7 m-10.0 m-10.1 m
Income tax7.0 k9.0 k6.0 k6.0 k6.0 k10.0 k7.0 k7.0 k
Net income-6.3 m-7.9 m-7.7 m-7.7 m-8.6 m-8.7 m-10.0 m-10.1 m
Diluted EPS-0.15—-0.18-0.18-0.17—-0.19-0.19
Operating cash flow-4.5 m ≈-6.4 m-7.1 m-7.6 m ≈-6.6 m ≈-7.8 m-9.1 m-8.1 m ≈
Capex9.0 k ≈7.0 k12.0 k6.0 k ≈16.0 k ≈6.0 k8.0 k3.0 k ≈

≈ derived quarter (cumulative difference / share-days average)

E/P over time

E/P = trailing-12-month diluted EPS / price at quarter end. E/P is the inverse of P/E and stays defined when earnings are negative.

Fiscal years

Fiscal year20182019202020212022202320242025
Revenue500.0 kunavailableunavailableunavailableunavailableunavailableunavailableunavailable
Revenue YoYunavailableunavailableunavailableunavailableunavailableunavailableunavailableunavailable
Net income-5.7 m-10.6 m-12.3 m-13.6 m-13.7 m-19.4 m-24.4 m-32.8 m
Net income YoYunavailableunavailableunavailableunavailableunavailableunavailableunavailableunavailable
Diluted EPSunavailableunavailableunavailable-0.65-0.52-0.60-0.60-0.70
Diluted EPS YoYunavailableunavailableunavailableunavailableunavailableunavailableunavailableunavailable
net %-1,146.8%unavailableunavailableunavailableunavailableunavailableunavailableunavailable
Free cash flow-5.7 m-9.1 m-9.2 m-12.3 m-11.6 m-18.8 m-22.1 m-29.1 m

Reported results vs expectations

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Balance sheet & financial health

Fiscal year 2025 · 31 Dec 2025

Cash
15.6 m USD
Financial debt
unavailable USD
Net debt
unavailable USD
Equity
56.1 m USD
Total assets
61.4 m USD
Debt / equity
unavailable
Current ratio
11.81x
ROE
-67.7%
ROA
-60.8%
FCF margin
unavailable

Financial statements (source on every figure)

Revenue and net income (USD)

Income statement · USD

Research & development
2023
13.1 m
2024
19.1 m
2025
24.6 m

SEC (XBRL)· 30 Mar 2026verified

Operating income
2023
-21.3 m
2024
-26.7 m
2025
-34.4 m

SEC (XBRL)· 30 Mar 2026verified

Pre-tax income
2023
-19.3 m
2024
-24.4 m
2025
-32.7 m

SEC (XBRL)· 30 Mar 2026verified

Income tax
2023
43.0 k
2024
30.0 k
2025
28.0 k

SEC (XBRL)· 30 Mar 2026verified

Net income
2023
-19.4 m
2024
-24.4 m
2025
-32.8 m

SEC (XBRL)· 30 Mar 2026verified

Diluted EPS
2023
-0.60
2024
-0.60
2025
-0.70

SEC (XBRL)· 30 Mar 2026verified

Balance sheet · USD

Cash
2023
4.5 m
2024
3.0 m
2025
15.6 m

SEC (XBRL)· 30 Mar 2026verified

Receivables
2023
369.0 k
2024
236.0 k
2025
258.0 k

SEC (XBRL)· 30 Mar 2026verified

Current assets
2023
53.7 m
2024
44.6 m
2025
60.6 m

SEC (XBRL)· 30 Mar 2026verified

Property, plant & equipment, net
2023
131.0 k
2024
148.0 k
2025
145.0 k

SEC (XBRL)· 30 Mar 2026verified

Total assets
2023
54.2 m
2024
46.3 m
2025
61.4 m

SEC (XBRL)· 30 Mar 2026verified

Accounts payable
2023
926.0 k
2024
940.0 k
2025
1.5 m

SEC (XBRL)· 30 Mar 2026verified

Current liabilities
2023
2.8 m
2024
5.4 m
2025
5.1 m

SEC (XBRL)· 30 Mar 2026verified

Equity
2023
51.1 m †
2024
40.7 m †
2025
56.1 m †

SEC (XBRL)· 30 Mar 2026verified

Cash flow · USD

Operating cash flow
2023
-18.7 m
2024
-22.1 m
2025
-29.1 m

SEC (XBRL)· 30 Mar 2026verified

Capex
2023
24.0 k
2024
25.0 k
2025
40.0 k

SEC (XBRL)· 30 Mar 2026verified

Free cash flow
2023
-18.8 m ≈
2024
-22.1 m ≈
2025
-29.1 m ≈

SEC (XBRL)· 30 Mar 2026derived

Investing cash flow
2023
-18.3 m
2024
8.6 m
2025
-2.2 m

SEC (XBRL)· 30 Mar 2026verified

Financing cash flow
2023
36.8 m
2024
12.0 m
2025
43.9 m

SEC (XBRL)· 30 Mar 2026verified

Computed indicators

Growth

Revenue growth (YoY)
unavailable
input data missing
Revenue CAGR 3Y
unavailable
input data missing
Revenue CAGR 5Y
unavailable
input data missing
EBIT growth (YoY)
unavailable
the base of the ratio is not positive
Net income growth (YoY)
unavailable
the base of the ratio is not positive
Net income CAGR 3Y
unavailable
input data missing
Net income CAGR 5Y
unavailable
input data missing
EPS growth (YoY)
unavailable
input data missing
EPS CAGR 3Y
unavailable
input data missing
EPS CAGR 5Y
unavailable
input data missing
FCF growth (YoY)
unavailable
the base of the ratio is not positive

Profitability

Gross margin
unavailable
input data missing
EBITDA margin
unavailable
input data missing
EBIT margin
unavailable
input data missing
Net margin
unavailable
input data missing
FCF margin
unavailable
input data missing

Returns

ROE
-114.6%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
ROA
-98.2%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
ROIC
unavailable
input data missing
ROCE
-102.1%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
Payout ratio (EPS)
unavailable
input data missing
Payout ratio (FCF)
unavailable
input data missing

Balance sheet

Net debt
unavailable
input data missing
Net debt / EBITDA
unavailable
input data missing
Debt / equity
unavailable
input data missing
Interest coverage
unavailable
input data missing

Liquidity

Current ratio
6.7x
computed by olivLawbalance sheet at 30 Jun 2026
Quick ratio
unavailable
input data missing
Cash ratio
0.8x
computed by olivLawbalance sheet at 30 Jun 2026

Cash

Operating cash flow
-31.5 m USD
computed by olivLawTTM to 30 Jun 2026
Capital expenditure
33.0 k USD
computed by olivLawTTM to 30 Jun 2026
Free cash flow
-31.5 m USD
computed by olivLawTTM to 30 Jun 2026
FCF conversion
unavailable
insufficient data
Cash conversion
unavailable
input data missing

Efficiency

Days sales outstanding
unavailable
input data missing
Days inventory outstanding
unavailable
input data missing
Days payables outstanding
unavailable
input data missing
Cash conversion cycle
unavailable
input data missing

Market and valuation

Market capitalisation
580.8 m USD
computed by olivLawbalance sheet at 30 Jun 2026
Enterprise value
unavailable
input data missing
Market cap / net income TTM
unavailable
insufficient data
P/E (TTM)
unavailable
insufficient data
Earnings yield
-6.5%
computed by olivLawTTM to 30 Jun 2026
P/B
15.1x
computed by olivLawbalance sheet at 30 Jun 2026
P/S
unavailable
input data missing
EV/EBITDA
unavailable
input data missing
EV/EBIT
unavailable
input data missing
EV/Sales
unavailable
input data missing
P/FCF
unavailable
the base of the ratio is not positive
FCF yield
-5.4%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
Dividend yield
unavailable
no dividend in the structured statements; a missing line is not a confirmed zero
Shareholder yield (distributions)
unavailable
input data missing

1 indicators that do not apply to the sector.

Valuation

olivLaw classification

Insufficient data
What is missing
  • indicators available: 2 of at least 6
  • score weight coverage: 12.5% of at least 60%
  • valuation methods computed: 0 of at least 1

A scoring methodology on indicators and valuation, not investment advice.

Closing price

10.77 USD

04 Nov 2026Source: olivLaw, closing series

Market cap: 580.8 m USD

Key indicators

Market capitalisation
580.8 m USD
computed by olivLawbalance sheet at 30 Jun 2026
P/E (TTM)
unavailable
insufficient data
P/B
15.1x
computed by olivLawbalance sheet at 30 Jun 2026
EV/EBITDA
unavailable
input data missing
ROE
-114.6%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
Net margin
unavailable
input data missing
Revenue growth (YoY)
unavailable
input data missing
Dividend yield
unavailable
no dividend in the structured statements; a missing line is not a confirmed zero

Coverage and freshness

19/37 reporting lines present
Latest full fiscal year: 2018
Latest reported period: 30 Jun 2026
Latest balance sheet date: 30 Jun 2026
Share count (cover of the latest filing), as of: 03 Aug 2026
Source: SEC (XBRL)published 10 Aug 2026
verified 823derived 72

Score by group

13% · Insufficient data

Estimated value range

unavailable — no valuation method could be computed

Valuation assumptions are editorial choices, not measured; beta is not measured.

Valuation methods

  • DCF (discounted cash flow)unavailable · input data missing
  • Peers: EV/EBITDAunavailable · net debt missing: EV cannot be bridged to equity (missing debt is not zero)
  • Peers: P/Eunavailable · the base of the ratio is not positive
  • Dividend discount (DDM)unavailable · the company pays no dividend: a dividend model needs an explicit initiation assumption

no valuation method could be computed

Multiple comparisons use the SIC vertical: Pharmaceutical Preparations (SIC 2834)

Classification (SIC) comparables group by industry code, not by economic activity; the direct group is an editorial selection by activity. Members' multiples are on their own trailing twelve months, at their own latest close.

Assumptions (illustrative, editorial)

Risk-free rate
4.3%
Equity risk premium
5.0%
Beta (default)
1.00
Cost of equity
9.3%
Terminal growth
2.5%

Factor scorecard

Insufficient data

Minimum-evidence gate: indicators available: 2 of at least 6; score weight coverage: 12.5% of at least 60%; valuation methods computed: 0 of at least 1

FactorValueScoreWeight used
ROIC · Qualityunavailableunavailable—
Net margin · Qualityunavailableunavailable—
FCF conversion · Qualityunavailableunavailable—
Revenue CAGR 3Y · Growthunavailableunavailable—
EPS CAGR 3Y · Growthunavailableunavailable—
Net debt / EBITDA · Balance sheetunavailableunavailable—
Interest coverage · Balance sheetunavailableunavailable—
Current ratio · Balance sheet6.7x100 (on a fixed band)33%
P/E (TTM) · Valuationunavailableunavailable—
EV/EBITDA · Valuationunavailableunavailable—
FCF yield · Valuation-5.4%0 (on a fixed band)67%
Shareholder yield (distributions) · Returnsunavailableunavailable—
Payout ratio (FCF) · Returnsunavailableunavailable—

Factors without a value were dropped; the remaining weights were renormalised.

Score groups

  • Balance sheet· partial100/100 · 1/3 factors with a value
  • Growth· partialunavailable · 0/2 factors with a value
  • Quality· partialunavailable · 0/3 factors with a value
  • Returns· partialunavailable · 0/2 factors with a value
  • Valuation· partial0/100 · 1/3 factors with a value

A «partial» group is computed from under half of its weight or from one factor: it is not a full assessment of the group.

Memo

DiaMedica Therapeutics Inc. (DMAC). Latest full fiscal year: 2018; data up to 2026-06-30.

Figures computed from the financial statements: ROE -114.6%.

Valuation cannot be computed from the available data.

Insufficient data for a verdict (indicators available: 2 of at least 6; score weight coverage: 12.5% of at least 60%; valuation methods computed: 0 of at least 1).

Text generated deterministically from the figures shown; no language model. Not investment advice.

What supports the thesis

  • Current ratio: 6.7x

What contradicts it

  • FCF yield: -5.4%

Not assessed (insufficient data or a ratio without meaning): ROIC, Net margin, FCF conversion, Revenue CAGR 3Y, EPS CAGR 3Y, Net debt / EBITDA, Interest coverage, P/E (TTM), EV/EBITDA, Shareholder yield (distributions), Payout ratio (FCF).

Versus the vertical median

Pharmaceutical Preparations (SIC 2834) · same industry (4-digit SIC) · compared with 39 companies

Multiples and returns vs the median

P/E
—
vertical median 32.4x
EV/EBITDA
—
vertical median 24.9x
P/S
—
vertical median 7.7x
P/B
15.1x
vertical median 5.7x
above median (+167.4%)
ROE
-114.6%
vertical median -9.5%
below median
Net margin
—
vertical median 3.6%
EBIT margin
—
vertical median -7.8%
Revenue YoY
—
vertical median 5.9%
Net debt/EBITDA
—
vertical median -0.0x
Dividend yield
—
vertical median 2.2%

Price rebased to 100 (monthly, 5 years)

Companies in the vertical

Market capP/EROENet marginRevenue YoY1A / 3A
LLYEli Lilly And Company1,325.9 bn45.786.1%31.9%+44.7%+31% / +138%
JNJJohnson & Johnson640.8 bn40.420.0%16.2%+6.0%+29% / +72%
ONCBeone Medicines Ltd.524.7 bn817.514.7%10.7%+40.2%+4% / +90%
ABBVAbbVie Inc.505.5 bn49.2—15.7%+8.6%+26% / +101%
MRKMerck & Co., Inc.356.9 bn115.67.0%4.8%+1.3%+38% / +41%
ABTAbbott Laboratories190.6 bn30.612.4%13.9%+5.7%−15% / +5%
PFEPfizer Inc171.0 bn42.74.4%6.3%−1.6%+17% / −2%
VRTXVertex Pharmaceuticals Inc134.6 bn34.220.8%30.7%+8.9%+22% / +50%
BMYBristol-Myers Squibb Company126.1 bn13.744.1%18.5%−0.2%+25% / +25%
TEVATeva Pharmaceutical Industries Limited48.9 bn97.66.6%3.6%+4.3%+56% / +327%
ZTSZoetis Inc.34.3 bn13.764.4%27.5%+2.3%−35% / −53%
ROIVRoivant Sciences Ltd.26.0 bn—-6.2%-3,535.0%−71.6%+73% / +277%
UTHRUnited Therapeutics Corporation25.8 bn21.519.3%41.6%+10.6%+24% / +151%
RPRXRoyalty Pharma plc25.8 bn37.68.5%32.1%+5.1%+66% / +145%
INSMInsmed Inc22.9 bn—-72.5%-39.9%+66.7%−50% / +317%
VTRSViatris Inc.21.7 bn—-23.6%-23.9%−3.0%+77% / +106%
ALNYAlnylam Pharmaceuticals, Inc.21.4 bn8.1126.6%52.8%+65.2%−65% / −5%
TGTXTg Therapeutics, Inc.9.4 bn22.5100.3%55.2%+87.3%+85% / +381%
BLRXBioLineRx Ltd4.9 bn—-12.8%-171.7%−95.9%−46% / −97%
BHCBausch Health Companies Inc.3.1 bn——-7.6%+6.7%+31% / +17%
ANABAnaptysbio, Inc.1.4 bn11.5—82.4%+157.0%+71% / +404%
KURAKura Oncology, Inc.677.0 m—-167.7%-384.3%+25.2%−37% / −21%
DMACDiaMedica Therapeutics Inc.580.8 m—-114.6%—unavailable+61% / +324%
PHATPhathom Pharmaceuticals, Inc.461.7 m——-30.2%+216.9%−64% / −19%
ALTAltimmune, Inc.412.4 m—-28.9%-223,804.9%+105.0%−60% / −33%

1- and 3-year price returns: for DMAC from daily closes (the same as the performance table), for the other companies from month-end closes.

olivLaw engine forecast

The world engine ran after the company's latest material disclosure. Probabilities are of TOUCHING a level within the horizon (not closing there) and sit next to the random walk (p_rw), the no-information benchmark.

The engine has no published run for this company yet.

Valuation scenarios (editable assumptions)

Illustrative scenarios

Scenarios are not available. input data missing

AI analysis

AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.

In brief

DiaMedica Therapeutics develops DM199, a recombinant form of human kallikrein-1, tested for preeclampsia, fetal growth restriction and acute ischemic stroke. The company is still in clinical stage with no approved products, and its net loss of 32.8 million USD in 2025 and cash reserve of 43.5 million USD at June 30, 2026 put funding and study results in focus now 13.

SWOT

Strengths

  • DM199 is the first recombinant kallikrein-1 studied clinically in patients, which could offer a more controlled safety profile than extracted forms 1.
  • Fast Track designation from the FDA for acute ischemic stroke can facilitate engagement with the regulator 1.
  • Interim preeclampsia results show rapid and sustained blood pressure reductions without observed placental transfer 13.

Weaknesses

  • The company has no approved products and no product revenue, so reliance on external funding is high 1.
  • Net losses rose in 2026 and operating cash use increased compared with the prior year 3.
  • ReMEDy2 enrollment has been slower than expected, which could postpone the regulatory timeline 13.

Opportunities

  • If clinical data confirm benefit in preeclampsia, the company could address an unmet need with no approved solutions 1.
  • A strategic partnership could support development and commercialization and ease pressure on internal funding 1.
  • Expanding studies to Canada and the United Kingdom could accelerate data generation for early-onset preeclampsia 3.

Threats

  • Additional FDA requirements on reproductive toxicity could delay entry into US studies 13.
  • If funding cannot be secured on acceptable terms, clinical programmes could be reduced or postponed 1.
  • Better-resourced competitors could develop alternatives faster, and the share price has been volatile 1.

Risks

  • Funding and continuityhigh

    The company has no product revenue and expects current resources to last through 2027, which could require new share issues and dilution 13.

  • FDA delayshigh

    The requested rabbit study could not be completed and alternative models could substantially delay the US timeline 1.

  • ReMEDy2 enrollmentmedium

    Slow site activation and difficult recruitment could postpone the interim analysis and completion of the study 12.

  • Acceptance of foreign datamedium

    The FDA could decline the South African study data, which would require additional participants or studies 2.

  • Safety and adverse effectsmedium

    Side effects of DM199 could limit its commercial profile or delay approval, and the company acknowledges product liability exposure 1.

Investment thesis

What would need to be true (bull case)

  • Interim preeclampsia results show significant and sustained blood pressure reductions, and the absence of approved therapies could offer a clear advantage if studies confirm benefit 13.
  • Fast Track status and Asian experience with kallikrein-1 could support a regulatory path faster than for an entirely new molecule 1.
  • If the ReMEDy2 interim analysis in 2027 is favourable, the company could have stronger grounds for partnerships and financing 3.

What would break the thesis

  • The company has no approved products and rising net losses, so additional funding could be needed before decisive results arrive 13.
  • FDA nonclinical requirements and slow ReMEDy2 enrollment could significantly delay the timeline 12.
  • If the South African data are not accepted or safety effects limit use, the programme's value could fall considerably 12.

What to watch

  • Detailed Part 1a preeclampsia results and conference presentation2026
  • First patient in the early-onset preeclampsia Phase 2 studyQ4 2026
  • ReMEDy2 interim analysisQ1 2027
  • Funding plans and length of the cash runway2027

Products, market & competition

AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.

The business

DiaMedica Therapeutics Inc. is a clinical-stage biopharmaceutical company, based in Minneapolis, focused on severe ischemic disease 13. Its lead candidate DM199 (rinvecalinase alfa) is the first pharmaceutically active recombinant form of human tissue kallikrein-1 studied clinically in patients and holds FDA Fast Track designation for acute ischemic stroke 1. Longer term, the company plans to develop DM300, a recombinant human ulinastatin, for severe acute pancreatitis 1.

Segments

Preeclampsia and fetal growth restriction

The preeclampsia and fetal growth restriction program is the main near-term priority, centred on an investigator-sponsored Phase 2 study at Tygerberg Hospital in Cape Town 13. Preeclampsia affects up to 8% of pregnancies and roughly 10 million cases occur each year, with no approved therapies in the United States or Europe 1.

Acute ischemic stroke

The Phase 2/3 ReMEDy2 trial initially aims to enroll about 300 participants, with an interim analysis after the first 200 13. The company expects the interim analysis in early 2027, and up to 80% of stroke patients are not eligible for current treatments 23.

Market context

The market DM199 targets includes preeclampsia, which affects up to 8% of pregnancies worldwide, and ischemic stroke, where up to 80% of patients cannot receive thrombolytics or thrombectomy 12. In Asia, kallikrein-1 derived from urine or pig pancreas has been used for decades, supporting a therapeutic market, although the company highlights regulatory differences versus the US and Europe 1.

The final market size for DM199 depends on clinical results, regulatory approvals and payer acceptance, and the company warns its estimates rest on assumptions that could prove inaccurate 1. Assessing the commercial opportunity therefore remains conditional on study progress.

Trends

  • Regulatory interest in preeclampsia therapiestailwind

    The lack of approved preeclampsia treatments creates an unmet need that could favour faster acceptance of candidates with Fast Track or Breakthrough status, if data are convincing 1.

  • Additional FDA requirementsheadwind

    The FDA requested extra nonclinical studies before a US Phase 2 start, and antibody responses seen in rabbits complicated their completion, which could delay the timeline 13.

  • Difficult enrollment in stroke trialsheadwind

    The company reports hospital staffing shortages, strict inclusion criteria and competition for patients, factors that slowed site activation and enrollment in ReMEDy2 12.

  • Acceptance of ex-US trial datamixed

    Data from the South African study could require added conditions or might not be accepted by the FDA, which could mean extra participants or trials 2.

Competitive position

The company describes its main competitors as Asian products based on urine-derived or porcine pancreas-derived kallikrein-1, sold in Japan, China and South Korea, where about 20 companies market the porcine form 1. In the US and Europe, the company states no comparable products are currently approved 1.

The company warns that in preeclampsia and stroke, better-resourced partners or rivals could accelerate alternative therapies, and DM199 could face competition sooner than expected 1.

  • Tech-pool BioPharma / Shanghai Pharmaceuticals

    Sells urine-derived kallikrein-1 (Kailikang) in China for ischemic stroke, according to the company 1.

  • Porcine pancreas-derived kallikrein-1 producers

    Around 20 companies sell this form in Japan, China and South Korea for hypertension and vascular disease 1.

  • Vasodilators with other mechanisms

    The company cites nitric oxide donors, prostacyclin analogues and endothelium-derived factor stimulators as preclinical alternatives without approvals 1.

  • Standard antihypertensives used in pregnancy

    The company notes common hypertension drugs cross the placental barrier or are contraindicated in pregnancy, leaving room for new therapies 1.

News & filings

In the press

No news in our archive over the last 180 days.

SEC filings

Sources

  1. [1] Form 10-K, fiscal year ended 2025-12-31 · SEC / DiaMedica Therapeutics Inc. · 30 Mar 2026
  2. [2] Form 10-Q, quarter ended 2026-06-30 · SEC / DiaMedica Therapeutics Inc. · 10 Aug 2026
  3. [3] Form 8-K, results release (exhibit 99.1) · SEC / DiaMedica Therapeutics Inc. · 10 Aug 2026

Figures computed by olivLaw from SEC filings and closing prices; the qualitative analysis is AI-generated from cited sources. Not investment advice.