Cardio-Renal Syndrome

PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 28 March 2024, 08:00 a.m. CET alfapump® – PMA1 submitted to US FDA and accepted for substantive review, extensive feedback just received from FDA which is currently under review by the Company DSR® – potential treatment for cardiorenal syndrome in heart failure presented at international heart failure conference, strong data from non-randomized cohort of US MOJAVE study Ghent, Belgium – 28 March 2024– Sequana Medical NV (Euronext Brussels: SEQUA) (the "Company" or "SequanaMedical"), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces its financial results for the year ended 31 December 2023, and provides a business update and outlook for 2024 and beyond. Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: “Securing PMA approval is a major value inflection point and the team is navigating through the approval process. Last night we received extensive feedback from the FDA on our PMA application and we will update the market as soon as we have completed the review thereof together with our external advisors. Subject to PMA approval, we believe US commercialization is derisked given our focus on the liver transplant centers that address the large majority of our target patients. Furthermore, the alfapump can benefit from attractive pricing and leverage its FDA breakthrough device designation to enhance its reimbursement position. We are excited by DSR as a potential treatment in cardiorenal syndrome, where there is a clear unmet need for therapies to effectively and durably address congestion and cardiorenal dysfunction. The data from our RED DESERT and SAHARA clinical studies demonstrate that DSR can not only completely replace loop diuretics during therapy but also deliver a dramatic and durable improvement in their diuretic responsiveness and reduction in chronic loop diuretic requirements. Looking ahead, we plan to initiate the randomized phase of the US MOJAVE study post alfapump PMA approval and expect interim data in the second half of 2025.” 2023 highlights North American alfapump liver program POSEIDON – one-year follow-up data from successful pivotal study in patients with recurrent or refractory ascites due to liver cirrhosis, confirms strong clinical pro alfapump Virtual elimination of needle paracentesis Robust safety pro disease progression Clinically meaningful improvement in patients’ quality of life maintained Survival probability of 70% at 12 and 18 months post-implant Patient preference study indicates that US patients have a strong preference for the alfapump vs large volume paracentesis2 Matched interim analysis of patients from NACSELD3 registry indicates that alfapump safety pro comparable to standard of care4 PMA application submitted to the US FDA in December 2023 DSR heart failure program Successful completion of IND5-enabling pre-clinical and Phase 1 studies of second-generation DSR product (DSR 2.0) Data from GLP6 studies in mice and sheep showed there was no difference in systemic and local toxic effects in animals treated repeatedly with DSR 2.0 compared to animals in the control group, concluding that DSR 2.0 had consistent safety with the standard peritoneal dialysis solution used in the control group Data from the Phase 1 CHIHUAHUA study in stable peritoneal dialysis patients demonstrated that a single dose of DSR 2.0 was safe and well-tolerated and indicated a compelling dosing pro > MOJAVE – all three patients from the non-randomized cohort in the US Phase 1/2a study of DSR 2.0 for treatment of congestive heart failure successfully treated with DSR 2.0, confirming the strong clinical outcomes seen in the RED DESERT and SAHARA proof-of-concept studies Safe and effective maintenance of euvolemia without the need for loop diuretics Durable improvement in cardio-renal health Dramatic improvement in diuretic response and at least 95% reduction in loop diuretic requirements up to almost four months after last DSR therapy Additional DSR patents granted in the US and China Additional US patents granted in February 2023 covering among other, the expansion of the composition of matter and method for Sequana Medical’s DSR therapy, including additional oncotic and osmotic agents and the use of an implantable pump system Key composition of matter patent was granted in China in March 2023 Corporate Established Sequana Medical US Inc. with an office in Boston which has been certified according to ISO 13485:2016 and MDSAP7 (USA and Canada) by BSI8, in preparation of the US commercial launch of the alfapump Expanded Board of Directors with the appointment of Dr. Kenneth Macleod in June 2023 and Ids van der Weij in November 2023 as non-executive directors Dr. Macleod is a partner at Rosetta Capital and brings more than 35 years’ experience in the life science sector from his senior operating roles in healthcare companies and life science fund management Mr. van der Weij is managing partner of Partners in Equity and brings more than 25 years’ corporate investment experience Raised €15.8 million in gross proceeds in April 2023 by means of an equity placement via an accelerated book building offering Cash position of €2.6 million at the end of December 2023, compared to €18.9 million at the end of December 2022 Post-period events North American alfapump liver program The American Medical Association granted six new CPT9 category III reimbursement codes in January 2024, available for use by healthcare professionals and payors as of July 1st, 2024, for procedures related to the alfapump system, including implantation, revision, removal and programming of the pump system, replacement of the pump and the catheters PMA application for alfapump accepted by the US FDA for substantive review in January 2024, ahead of anticipated timing DSR heart failure program The independent Data Safety Monitoring Board approved the start of the MOJAVE randomized cohort of up to 30 additional patients following review of data from non-randomized cohort in January 2024 Three-month follow-up data from all three patients in the MOJAVE non-randomized cohort confirmed dramatic improvement in diuretic response and virtual elimination of loop diuretics following DSR therapy Strong data supporting DSR’s role as potential treatment for cardiorenal syndrome based on results of RED DESERT and SAHARA proof-of-concept DSR studies presented during late-breaking session at leading international heart failure conference, THT 2024 Corporate Company’s cash runway extended to end of Q3 2024 In February 2024, the Company announced a significantly reduced cash burn through 1) the focus on obtaining alfapump PMA approval, 2) postponing the start of the randomized cohort of the DSR MOJAVE study to after reaching alfapump PMA approval, and 3) halting all European commercial activities for alfapump In February 2024, the Company’s lenders agreed to defer all debt service payments until after alfapump PMA approval decision In March 2024, the Company raised €11.5 million in gross proceeds by means of an equity placement via an accelerated book building offering. Following this equity placement, the €3.0 million convertible loan agreement entered in February 2024 by Partners in Equity and Rosetta Capital will be mandatorily converted into new shares. Outlook for 2024 and beyond The Company is currently reviewing the extensive feedback which was received from the FDA yesterday (day-90 after PMA filing) on its alfapump PMA application together with its external advisors and will update the market in due course. A day-100 meeting is scheduled with the FDA on April 9th 2024. For the DSR heart failure program, the Company will start the randomized cohort of the US Phase 1/2a MOJAVE study after reaching PMA approval for its alfapump. The start of the randomized phase is currently anticipated in Q1 2025, including up to 30 additional diuretic-resistant heart failure patients, with up to 20 patients treated with DSR 2.0 and up to 10 patients treated with intravenous loop diuretics, and interim data are expected in H2 2025. Detailed financial review in Thousand Euros (if not stated otherwise) FY 2023 FY 2022 Change Revenue 712 923 -23% Cost of goods sold (164) (205) -20% Gross margin 548 718 -24% Sales & Marketing (1,799) (2,240) -20% Clinical (6,947) (9,773) -29% Quality & Regulatory (5,586) (3,632) +54% Supply Chain (4,724) (3,158) +50% Engineering (4,041) (3,853) +5% General & Administration (6,943) (6,687) +4% Total operating expenses (30,040) (29,343) +2% Other income 629 530 +19% Earnings before interest and taxes (EBIT10) (28,862) (28,094) +3% Finance income 1,052 451 +133% Finance cost (4,288) (2,733) +57% Total net finance expense (3,236) (2,282) +42% Income tax expense (466) (387) +20% Net loss for the period (32,564) (30,763) +6% Basic Loss Per Share (in Euros) (1.22) (1.35) -10% Cash position* at 31 December 2,584 18,875 -86% N.M.: Not Meaningful (percentage greater than 150%) * Cash position only includes cash and cash equivalents. Consolidated statements of profit and loss Revenue Revenue decreased from €0.92 million in 2022 to €0.71 million in 2023 due to the decision to scale back European commercial activities in April 2023. Cost of goods sold Cost of goods sold decreased from €0.21 million in 2022 to €0.16 million in 2023 in line with the decrease in revenue. Operating expenses Total operating expenses remained broadly unchanged from €29.34 million in 2022 to €30.04 million in 2023, and are mainly related to the preparations of the submissions for marketing approval of the alfapump in the US. Sales and marketing expenses decreased from €2.24 million in 2022 to €1.80 million in 2023 due to the decision to scale back European commercial activities. Clinical expenses decreased from €9.77 million in 2022 to €6.95 million in 2023 mainly as a result of lower costs related to the North American pivotal POSEIDON study of the alfapump and the completion of the SAHARA DSR proof-of-concept study in 2022, partially compensated by pre-clinical and clinical development work required for the Company’s IND filing for its proprietary DSR product and commencement of the MOJAVE study in the US. Quality and Regulatory expenses increased from €3.63 million in 2022 to €5.59 million in 2023, mainly driven by external advice and testing solicited for the preparation of the submissions for marketing approval of the alfapump in the US. Supply chain expenses increased from €3.16 million in 2022 to €4.72 million in 2023 largely driven by additional staffing and external advice for the preparation of the submissions for marketing approval of the alfapump in the US and higher production costs. Engineering expenses increased from €3.85 million in 2022 to €4.04 million in 2023, largely driven by test samples required for the preparation of the submissions for marketing approval of the alfapump in the US. General and Administration expenses remained broadly unchanged, from €6.69 million in 2022 to €6.94 million in 2023. Other income remained broadly unchanged from €0.53 million in 2022 to €0.63 million in 2023. EBIT Earnings before interest and taxes (EBIT) remained broadly unchanged from a loss of €28.09 million in 2022 to a loss of €28.86 million in 2023. Total net finance expenses Net finance cost increased from €2.28 million in 2022 to €3.24 million in 2023, mainly resulting from the valuation of the Investor Warrants (non-cash item) and debt related interest expenses compensated by the valuation of the Bootstrap Warrants and Kreos Subscription Rights (both non-cash items). Income tax expense Income tax expense remained broadly unchanged from €0.39 million in 2022 to €0.47 million in 2023. Net loss for the period As a result of the above, the net loss increased from €30.76 million in 2022 to €32.56 million in 2023. Basic losses per share (LPS) Basic losses per share decreased from €1.35 in 2022 to €1.22 in 2023. Consolidated balance sheet Net debt Net debt11 at 31 December 2023 increased by €16.22 million compared to 31 December 2022. Working Capital Working capital12 in 2023 decreased by €0.32 million compared to 2022, mainly as a result of a decrease in trade payables and other payables. Liquidity The Company is still in its development phase and conducting clinical trials in order to achieve regulatory marketing approvals, which incurs various risks and uncertainties, including but not limited to the uncertainty of the development process and the timing of achieving profitability. The Company’s ability to continue operations also depends on its ability to raise additional capital and to refinance existing debt, in order to fund operations and assure the solvency of the Company until revenues reach a level to sustain positive cash flows. The impact of macroeconomic conditions and geopolitical situation in Ukraine and the Middle East on the Company’s ability to secure additional financing rounds or undertake capital market transactions remains unclear at this point in time and will remain under review by the Executive Management and the Board of Directors. The above conditions indicate the existence of material uncertainties, which may also cast significant doubt about the Company’s ability to continue as a going concern. The Company will continue to require additional financing in the near future and in that respect already entered a €3.0 million mandatory convertible loan agreement in February 2024 with Partners in Equity and Rosetta Capital and successfully raised €11.5 million gross proceeds in March 2024 in a private equity placement via an accelerated bookbuild offering. Together with existing cash resources, the net proceeds from this financing round are expected to extend the current cash runway of the Company to the end of Q3 2024. The Company continues to evaluate equity and other financing options, including discussions with existing as well as new investors. The Executive Management and the Board of Directors remain confident about the strategic plan, which comprises additional financing measures including equity and/or other financing sources, and therefore consider the financial information in this press release on a going concern basis as appropriate. Consolidated statement of cash flows Net cash outflow from operating activities was €29.06 million in 2023 compared to €27.48 million in 2022. The outflow was mainly driven by higher net loss of the period. Cash flow from investing activities resulted in a net outflow of €0.72 million in 2023, compared to a net outflow of €0.65 million in 2022. Cash flow from financing activities resulted in a net inflow of €13.46 million in 2023, mainly as a result of the proceeds from the equity placement in H1 2023 partially compensated by repayments of financial debt and interest. In 2022, the net inflow of €37.32 million was mainly a result of the proceeds from the equity placement in H1 2022, and the €10 million loan facility with Kreos Capital secured in H2 2022. The Company ended 2023 with a total cash and cash equivalents amount of €2.58 million (2022: €18.87 million). 2024 Financial Calendar 23 April 2024 Online publication of Annual Report 2023 23 May 2024 Annual General Meeting 2024 For more information, please contact: Sequana Medical Lies Vanneste Director Investor Relations E: IR@sequanamedical.com T: +32 (0)498 05 35 79 About Sequana Medical Sequana Medical NV is a pioneer in treating fluid overload, a serious and frequent clinical complication in patients with liver disease, heart failure and cancer. This causes major medical issues including increased mortality, repeated hospitalizations, severe pain, difficulty breathing and restricted mobility. Although diuretics are standard of care, they become ineffective, untolerable or exacerbate the problem in many patients. There are limited effective treatment options, resulting in poor clinical outcomes, high costs and a major impact on their quality of life. Sequana Medical is seeking to provide innovative treatment options for this large and growing "diuretic-resistant" patient population. alfapump® and DSR® are Sequana Medical's proprietary platforms that work with the body to treat diuretic-resistant fluid overload, delivering major clinical and quality of life benefits for patients and reducing costs for healthcare systems. The Company's Premarket Approval (PMA) application for the alfapump was submitted to the US FDA in December 2023 and accepted for substantive review in January 2024, having reported positive primary and secondary endpoint data from the North American pivotal POSEIDON study in recurrent or refractory ascites due to liver cirrhosis. Results of the Company's RED DESERT and SAHARA proof-of-concept studies in heart failure support DSR's mechanism of action as breaking the vicious cycle of cardiorenal syndrome. All three patients from the non-randomized cohort of MOJAVE, a US randomized controlled multi-center Phase 1/2a clinical study, have been successfully treated with DSR, resulting in a dramatic improvement in diuretic response and virtual elimination of loop diuretic requirements. The independent Data Safety Monitoring Board approved the start of the randomized MOJAVE cohort of up to a further 30 patients, which is planned after alfapump US PMA approval. Sequana Medical is listed on Euronext Brussels (Ticker: SEQUA.BR) and headquartered in Ghent, Belgium. For further information, please visit . Important Regulatory Disclaimers The alfapump® system is currently not approved in the United States or Canada. In the United States and Canada, the alfapump system is currently under clinical investigation (POSEIDON Trial) and is being studied in adult patients with refractory or recurrent ascites due to liver cirrhosis. DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. There is no link between DSR therapy and ongoing investigations with the alfapump system in Europe, the United States or Canada. Note: alfapump® and DSR® are registered trademarks. Forward-looking statements This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent the current judgment of Sequana Medical on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release. Financial information The financial statements have been prepared in accordance with IFRS, as adopted by the EU. The financial information included in this press release is an extract from the full IFRS consolidated financial statements which will be published on 23 April 2024. As of the date of this press release, the statutory auditor, PricewaterhouseCoopers Bedrijfsrevisoren BV, with registered office at Culliganlaan 5, 1831 Machelen, Belgium, represented by Peter D’hondt, auditor, has not yet completed his audit procedures on the IFRS consolidated statements as of and for the year ended 31 December 2023. The statutory auditor has confirmed that the audit, which is substantially complete, has not to date revealed any material misstatement in the draft consolidated accounts, and that the accounting data reported in the press release is consistent, in all material respects, with the draft consolidated accounts from which it has been derived. Consolidated statement of profit and loss in Thousand Euros (if not stated otherwise) Year ended 31 December 2023 2022 Revenue 712 923 Cost of goods sold (164) (205) Gross margin 548 718 Sales & Marketing (1,799) (2,240) Clinical (6,947) (9,773) Quality & Regulatory (5,586) (3,632) Supply Chain (4,724) (3,158) Engineering (4,041) (3,853) General & Administration (6,943) (6,687) Total operating expenses (30,040) (29,343) Other income 629 530 Earnings before interests and taxes (EBIT) (28,862) (28,094) Finance income 1,052 451 Finance cost (4,288) (2,733) Total net finance expense (3,236) (2,282) Income tax expense (466) (387) Net loss for the period (32,564) (30,763) Basic losses per share (in Euro) (1.22) (1.35) Consolidated statement of comprehensive income in Thousand Euros (if not stated otherwise) Year ended 31 December 2023 2022 Net loss for the period (32,564) (30,763) Components of other comprehensive income (OCI) items that will not be reclassified to profit or loss: Remeasurements of defined benefit plans (356) 413 Items that may be reclassified subsequently to profit or loss: Currency translation adjustments (64) 727 Total other comprehensive income/(loss)-net of tax (420) 1,140 Total comprehensive income (32,984) (29,623) Attributable to Sequana Medical shareholders (32,984) (29,623) Consolidated balance sheet in Thousand Euros (if not stated otherwise) As at 31 December 2023 2022 ASSETS Property, plant and equipment 2,316 2,068 Financial Assets 100 86 Other non-current assets 1,388 782 Total non-current assets 3,805 2,936 Trade receivables 43 114 Other receivables and prepaid expenses 1,373 1,479 Inventory 2,296 2,621 Cash and cash equivalents 2,584 18,875 Total current assets 6,296 23,089 Total assets 10,101 26,025 EQUITY AND LIABILITIES Share capital 2,926 2,460 Share premium 185,644 170,324 Reserves (2,896) (2,426) Loss brought forward (206,022) (173,458) Cumulative translation adjustment 882 946 Total equity (19,465) (2,153) Long term financial debts 8,969 12,193 Long term lease debts 464 609 Retirement benefit obligation 668 228 Total non-current liabilities 10,101 13,030 Short term financial debts 7,818 4,483 Short term lease debts 269 307 Other current financial liabilities 2,767 1,569 Trade payables and contract liabilities 2,907 3,392 Other payables 2,257 1,812 Accrued liabilities and provisions 3,448 3,586 Total current liabilities 19,466 15,148 Total equity and liabilities 10,101 26,025 Consolidated statement of cash flows in Thousand Euros (if not stated otherwise) Year ended 31 December 2023 2022 Net loss for the period (32,564) (30,763) Income tax expense 466 387 Financial result 3,271 1,923 Depreciation 661 312 Change in defined benefit plan (50) (102) Share-based compensation 564 564 Changes in trade and other receivables (543) (457) Changes in inventories 483 42 Changes in trade and other payables/provisions (905) 990 Taxes paid (446) (378) Cash flow used in operating activities (29,063) (27,482) Investments in tangible fixed assets (711) (677) Investments in financial assets (11) 24 Cash flow used in investing activities (721) (653) Proceeds from capital increase 15,786 28,420 (Repayments) from leasing debts (414) (407) (Repayments) from financial debts (982) - Proceeds from financial debts - 9,626 Interest paid (929) (315) Cash flow from financing activities 13,461 37,324 Net change in cash and cash equivalents (16,324) 9,189 Cash and cash equivalents at the beginning of the period 18,875 9,600 Net effect of currency translation on cash and cash equivalents 33 85 Cash and cash equivalents at the end of the period 2,584 18,875 Consolidated statement of changes in equity in Thousand Euros (if not stated otherwise) Share capital Share premium Reserves Loss brought forward Currency translation differences Total shareholder equity Balance at 1 January 2022 1,925 142,433 (2,669) (142,695) 220 (787) Net loss for the period (30,763) (30,763) Other comprehensive income 413 727 1,140 March 2022 Equity Placement 535 27,885 28,420 Capital increase Share Options 0 7 7 Transaction costs for equity instruments (735) (735) Share-based compensation 564 564 Balance at 31 December 2022 2,460 170,324 (2,426) (173,458) 946 (2,153) Balance at 1 January 2023 2,460 170,324 (2,426) (173,458) 946 (2,153) Net loss for the period (32,564) (32,564) Other comprehensive income (356) (64) (420) April 2023 Equity Placement 461 15,320 15,780 Capital increase 10/23 5 0 6 Transaction costs for equity instruments (678) (678) Share-based compensation 564 564 Balance at 31 December 2023 2,926 185,644 (2,896) (206,022) 882 (19,465) 1 PMA: Pre-Market Approval 2 Patient preference study using discrete-choice experiment methodology to elicit patient preference for attributes of an implantable pump as a novel interventional treatment for ascites, N=125 US patients with comparable patient pro pivotal cohort in POSEIDON study 3 NACSELD: North American Consortium for the Study of End stage Liver Disease 4 Comparing outcomes in terms of death, hospitalization rate and liver transplant of POSEIDON pivotal cohort (6 months post-implant) to matched patient group from NACSELD registry with POSEIDON 5 IND: Investigational New Drug 6 GLP: Good Laboratory Practice 7 MDSAP: Medical Device Single Audit Program 8 BSI: British Standards Institution 9 CPT: Current Procedural Terminology 10 EBIT is defined as revenue less cost of goods sold and operating expenses. 11 Net debt is calculated by adding short-term, long-term financial and lease debt and deducting cash and cash equivalents. 12 The components of working capital are inventory + trade receivables + other receivables and prepaid expenses - trade payables - other payables - accrued liabilities and provisions. Attachments Press Release_FYR 2023_28 March 2024_NL_vF Press Release_FYR 2023_28 March 2024_ENG_vF

Conference Call and Webcast March 20 at 8:00 AM Eastern Time / 7:00 AM Central Time ReMEDy2 Clinical Site Activation Commenced in December 2023 Strengthened Management Team with Lorianne Masuoka, M.D., as Chief Medical Officer $53 Million Cash with Runway to 2026 MINNEAPOLIS--(BUSINESS WIRE)-- DiaMedica Therapeutics, Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and cardio-renal disease, today provided a business update and financial results for the year ended December 31, 2023. Management will host a conference call Wednesday, March 20, 2024, at 8:00 AM Eastern Time / 7:00 AM Central Time to discuss its business update and full year 2023 financial results. ReMEDy2 Phase 2/3 AIS Clinical Developments DiaMedica has been actively engaging with clinical study sites in the United States and globally. In the U.S., the first clinical sites were opened in December 2023 and as of the date of this press release, six sites have been opened. The majority of the U.S. sites are expected to be activated by the third quarter of 2024. With the support of the Canadian Stroke Consortium, the activation of study sites in Canada is expected to begin in the third quarter of 2024. In Australia, the Company has received provisional endorsement from the Australian Stroke Trials Network (ASTN) and Australian site activation is expected to commence in the fourth quarter of 2024. Initial steps are also being taken to expand ReMEDy2 into the United Kingdom and Europe. As previously discussed, the Company submitted a protocol modification to the U.S. Food and Drug Administration (FDA) in October 2023 intended to enhance the probability of clinical success in the ReMEDy2 clinical trial. These modifications included focusing participant eligibility to those subjects with only moderate acute ischemic strokes (AIS) in the anterior circulation. Moderate strokes are commonly defined as those stroke patients having a baseline National Institutes of Health Stroke Score (NIHSS) of 5-15. Moderate severity strokes frequently result from occlusions in small vessels, and if diagnosed after the tissue plasminogen activator (tPA; ACTIVASE®) treatment window has closed, typically have limited treatment alternatives as they are generally not candidates for mechanical thrombectomy. The exclusion of posterior circulation strokes aligns with enrollment criteria used by Shanghai Pharmaceuticals, the marketer of urinary-derived KLK1, called KAILIKANG®, in its registration studies in China. Given the ReMEDy2 primary endpoint of modified Rankin Scale (mRS) score of 0-1 (excellent outcome), the Company believes that focusing on strokes of moderate severity will maximize the potential performance improvement in participants treated with DM199 vs. placebo, meaning that this change should increase the number of participants receiving DM199 achieving an excellent outcome as compared to the placebo group. This change is also consistent with results from the Company’s Phase 2, ReMEDy1 stroke trial, where the subgroup of participants with moderate strokes, not receiving mechanical thrombectomy prior to enrollment, showed a greater percentage of patients on DM199 achieving an mRS of 0-1 compared to placebo, recognizing that the trial had a relatively small number of participants. At this time, based upon information obtained from current and potential clinical study sites, the Company believes that full enrollment for the 144 patients for the interim analysis will be completed in the first quarter of 2025. For more information about the ReMEDy2 AIS Phase 2/3 clinical trial, please visit ( ). Dr. Lorianne Masuoka joined DiaMedica in January 2024 with more than 25 years of experience building and expanding high value pipelines in the biopharmaceutical industry that have resulted in drug approvals and strategic alliances. She is a board-certified neurologist, experienced in treating stroke patients, who has successfully created and overseen high performing teams to lead the clinical development of new medicines, with a focus in neurology and oncology. Dr. Masuoka served as Chief Medical Officer of Epygenix Therapeutics, Marinus Pharmaceuticals (Nasdaq: MRNS), Cubist Pharmaceuticals ($9.5B acquisition by Merck), and Nektar Therapeutics (Nasdaq: NKTR) where, as a member of executive management, she managed teams in the areas of clinical research, pharmacovigilance, biostatistics and data management, regulatory affairs, and clinical operations. Previously, she held various roles of increasing responsibility at FivePrime Therapeutics ($1.9B acquisition by Amgen) and Chiron (now Novartis). In addition to her executive roles, Dr. Masuoka most recently served as a Board member at Pfenex Inc. ($516M acquisition by Ligand) and served as a Board member at Opiant Pharmaceuticals (up to $500M acquisition by Indivior). Dr. Masuoka received her medical degree from the University of California, Davis, where she also completed her residency in neurology. She completed her epilepsy fellowship at Yale University and is board certified by the American Board of Psychiatry and Neurology. Lorianne also recruited a former colleague to join DiaMedica’s team as Vice President of Clinical Operations. Ms. Rebekah de Vitry Fries has over 15 years of clinical operations experience including Epygenix Therapeutics; Takeda and Marinus Pharmaceuticals. “We have been focused on engaging and activating high-quality stroke centers to set the foundation for patient enrollment,” commented Dr. Masuoka. “We are encouraged by the level of interest from quality study sites and are committed to bringing DM199 to stroke patients.” Balance Sheet and Cash Flow DiaMedica reported 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, compared to total cash, cash equivalents and investments of $33.5 million, $2.2 million in current liabilities and $31.7 million in working capital as of December 31, 2022. The increases in cash, cash equivalents and investments and in working capital were due primarily to the $36.8 million of net proceeds from the April and June 2023 private placements, partially offset by cash used to fund operating activities during the year ended December 31, 2023. Net cash used in operating activities for the year ended December 31, 2023 was $18.7 million compared to $11.5 million for the year ended December 31, 2022. The increase in cash used in operating activities was driven primarily by the Company’s higher net loss and increased amortization of discounts on purchased marketable securities, partially offset by non-cash share-based compensation and the effects of the changes in operating assets and liabilities during 2023. Financial Results Research and development (R&D) expenses increased to $13.1 million for the year ended December 31, 2023, up from $7.8 million for the year ended December 31, 2022. The increase was driven principally by costs incurred for the in-use studies performed to address the previous clinical hold on the Company’s ReMEDy2 AIS trial, costs incurred for the Phase 1C study and increased manufacturing and process development costs for DM199. Also contributing to the increase were higher personnel costs, including non-cash share-based compensation, associated with expanding the clinical team. DiaMedica expects its R&D expenses to increase moderately as we globally expand the ReMEDy2 trial. The increases will be moderated by the completion of prior clinical trials during 2023. General and administrative (G&A) expenses were $8.2 million for the year ended December 31, 2023, up from $6.2 million for the year ended December 31, 2022. This increase was primarily driven by increased legal fees incurred in connection with the Company’s lawsuit against Pharmaceutical Research Associates Group B.V. (PRA Netherlands) and increased personnel costs incurred in conjunction with expanding the Company’s team. Increased costs for patent prosecution and non-cash share-based compensation also contributed to the increase. DiaMedica expects that its G&A costs we will remain steady or decline slightly as compared to prior periods. Other income, net, was $1.9 million for the year ended December 31, 2023 compared to $0.4 million for 2022. This increase was driven by increased interest income recognized during 2023 as compared to 2022, related to both higher interest rates and increased marketable securities balances during 2023. Conference Call and Webcast Information DiaMedica Management will host a conference call and webcast to discuss its business update and full year quarter 2023 financial results on Wednesday, March 20, 2024, at 8:00 AM Eastern Time / 7:00 AM Central Time: Date: Wednesday, March 20, 2024 Time: 7:00 AM CDT / 8:00 AM EDT Web access: Dial In: (877) 550-1858 Conference ID: 1754341 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 the Company’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 27, 2024, by dialing (800) 645-7964 (U.S. Toll Free) and entering the replay passcode: 2125#. About 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 (AIS) patients. The trial is intended to enroll approximately 350 patients at up to 100 sites in the United States with planned global expansion. 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 treated with tissue plasminogen activator (tPA) and/or mechanical thrombectomy. DiaMedica believes that the proposed trial has the potential to serve as a pivotal registration study of DM199 in this patient population. About DM199 DM199 is a recombinant (synthetic) form of human tissue kallikrein-1 (rKLK1; rinvecalinase alpha). rKLK1 is identical to naturally produced KLK1, 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 and prostacyclin. In the case of ischemic stroke, the administration of DM199 is intended to enhance blood flow to infarction (blood clot) site and boost neuronal survival in the ischemic penumbra by dilating arterioles surrounding the site of the infarction and inhibition of apoptosis (neuronal cell death) while also facilitating neuronal remodeling through the promotion of angiogenesis. KLK1 deficiency may play a role in multiple vascular and fibrotic diseases such as stroke, chronic kidney disease, retinopathy, vascular dementia, and resistant hypertension where current treatment options are limited or ineffective. DiaMedica is the first company to have developed and clinically studied rKLK1. Non-recombinant, tissue extracted KLK1 protein, produced from the pancreas of pigs and human urine, has been approved for decades outside the U.S. and Europe for patients in Japan, China and South Korea with a variety of ischemic conditions such as AIS, chronic renal disease, retinopathy and hypertension. DM199 is currently being studied in patients with AIS. In September 2021, the FDA granted Fast Track Designation to DM199 for the treatment of AIS. About DiaMedica Therapeutics Inc. DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company committed to improving the lives of people suffering from serious diseases with a focus on 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 Asia for the treatment of acute ischemic stroke and other vascular diseases. For more information visit the Company’s website at . 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,” “look forward,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “hope,” “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 protocol amendments to increase the probability of clinical success of DM199 for the treatment of AIS in the ReMEDy2 trial and streamline the site selection and activation process, timing for site activations and geographic locations thereof and enrollment in the ReMEDy2 trial, anticipated clinical benefits and success of DM199, and cash runway to 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, uncertainties relating to the effects of the protocol amendments, timing of 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; 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 cardio-renal disease and its expectations regarding the benefits of DM199; DiaMedica’s ability to conduct successful clinical testing of DM199 and within its anticipated parameters, 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 planned clinical trials and obtain regulatory approvals for DM199 for acute ischemic stroke and cardio-renal disease, 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 U.S. Securities and Exchange Commission filings. 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) Year Ended December 31, 2023 2022 Operating expenses: Research and development $ 13,110 $ 7,839 General and administrative 8,157 6,162 Total operating expenses 21,267 14,001 Operating loss (21,267 ) (14,001 ) Other income: Other income, net 1,929 353 Total other income, net 1,929 353 Loss before income tax expense (19,338 ) (13,648 ) Income tax expense (43 ) (28 ) Net loss (19,381 ) (13,676 ) Other comprehensive income (loss) Unrealized gain (loss) on marketable securities 80 (23 ) Net loss and comprehensive loss $ (19,301 ) $ (13,699 ) Basic and diluted net loss per share $ (0.60 ) $ (0.52 ) Weighted average shares outstanding – basic and diluted 32,566,723 26,443,067 DiaMedica Therapeutics Inc. Condensed Consolidated Balance Sheets (In thousands, except share amounts) December 31, 2023 December 31, 2022 ASSETS Current assets: Cash and cash equivalents $ 4,543 $ 4,728 Marketable securities 48,352 28,774 Prepaid expenses and other assets 411 251 Amounts receivable 369 82 Total current assets 53,675 33,835 Non-current assets: Operating lease right-of-use asset 354 424 Property and equipment, net 131 136 Total non-current assets 485 560 Total assets $ 54,160 $ 34,395 LIABILITIES AND EQUITY Current liabilities: Accounts payable $ 926 $ 734 Accrued liabilities 1,777 1,365 Finance lease obligation 3 6 Operating lease obligation 80 63 Total current liabilities 2,786 2,168 Non-current liabilities: Finance lease obligation, non-current 1 4 Operating lease obligation, non-current 316 396 Total non-current liabilities 317 400 Commitments and contingencies (Note 10) Shareholders’ equity: Common shares, no par value; unlimited authorized; 37,958,000 and 26,443,067 shares issued and outstanding, as of December 31, 2023 and 2022, respectively — — Paid-in capital 166,609 128,078 Accumulated other comprehensive income (loss) 6 (74 ) Accumulated deficit (115,558 ) (96,177 ) Total shareholders’ equity 51,057 31,827 Total liabilities and shareholders’ equity $ 54,160 $ 34,395 DiaMedica Therapeutics Inc. Condensed Consolidated Statements of Cash Flows (In thousands) Year Ended December 31, 2023 2022 Cash flows from operating activities: Net loss $ (19,381 ) $ (13,676 ) Adjustments to reconcile net loss to net cash used in operating activities: Share-based compensation 1,683 1,502 Amortization of discounts on marketable securities (1,223 ) (11 ) Non-cash lease expense 70 64 Depreciation 30 25 Changes in operating assets and liabilities: Amounts receivable (287 ) 48 Prepaid expenses and other assets (160 ) (54 ) Accounts payable 192 225 Accrued liabilities 348 366 Net cash used in operating activities (18,728 ) (11,511 ) Cash flows from investing activities: Purchase of marketable securities (69,410 ) (45,684 ) Maturities of marketable securities 51,135 57,303 Purchase of property and equipment (24 ) (81 ) Net cash provided by (used in) investing activities (18,299 ) 11,538 Cash flows from financing activities: Proceeds from issuance of common shares, net of offering costs 36,848 — Principal payments on finance lease obligations (6 ) (6 ) Net cash provided by (used in) financing activities 36,842 (6 ) Net increase (decrease) in cash and cash equivalents (185 ) 21 Cash and cash equivalents at beginning of period 4,728 4,707 Cash and cash equivalents at end of period $ 4,543 $ 4,728 Supplemental disclosure of cash flow information: Cash paid for income taxes $ 33 $ 27 Assets acquired under operating lease $ — $ 446

Presentation by Key Opinion Leader Dr. Testani on Wednesday, March 6th 2024 Ghent, Belgium – 28 February 2024– Sequana Medical NV (Euronext Brussels: SEQUA) (the "Company" or "SequanaMedical"), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces that the late-breaking abstract including data from the RED DESERT and SAHARA proof-of-concept studies of the Company’s DSR therapy in patients with diuretic-resistant heart failure have been selected for a late-breaking presentation at THT 2024. Technology and Heart failure Therapeutics (THT) will be held from March 4th to 6th, 2024 in Boston, US and is an international conference on the latest heart failure innovations, focusing on device- and technology-based treatments within the context of drug therapies. The abstract “Serial Direct Sodium Removal in Patients with Heart Failure and Diuretic Resistance” will be presented on Wednesday March 6th, 2024 by Dr. Jeffrey Testani, Associate Professor of Medicine and Director of Heart Failure Research at Yale University School of Medicine and will become available on the website of THT prior to the start of the conference. For more information, please contact: Sequana Medical Lies Vanneste Director Investor Relations E: IR@sequanamedical.com T: +32 (0)498 053579 About DSR, a disease-modifying heart failure drug therapy tackling cardiorenal syndrome (CRS) Cardiorenal syndrome is a key clinical challenge in heart failure and results from the combined vicious cycle of dysfunction of the heart and kidney. Despite the complex pathophysiology, the resultant clinical pro thought to manifest as a self-reinforcing negative feedback cycle characterized by decreased glomerular filtration, increased renal sodium avidity, and congestion, despite escalating diuretic doses. No current therapies have been shown to improve patient outcomes in this complex and poorly understood indication. Reducing congestion is a key element of therapy but loop diuretics exacerbate many of the core mechanisms thought to underly CRS. Through effective control of the volume status for an extended period of time and thereby avoiding the negative consequences of loop diuretics, DSR has the potential to break the negative feedback cycle of this clinical challenge. Extensive analysis of patients in the RED DESERT and SAHARA studies shows the benefit from DSR therapy on i) volume status, ii) normalized diuretic response and dramatically reduced loop diuretic dosing, iii) improvement in kidney function, iv) neurohormonal status and signalling, as well as v) cardiovascular parameters. In these patients there were no congestion-related re-hospitalizations, a one class improvement in their NYHA status and a reduction of 75% in their predicated one-year mortality (based on the Seattle Heart Failure model). Initial data from the non-randomized cohort in the US MOJAVE study support these findings and indicated that DSR is safe and well tolerated, restores diuretic response and improves cardio-renal health. Data from the RED DESERT and SAHARA proof-of-concept studies have been submitted for publication in a peer-reviewed journal. About Sequana Medical Sequana Medical NV is a pioneer in treating fluid overload, a serious and frequent clinical complication in patients with liver disease, heart failure and cancer. This causes major medical issues including increased mortality, repeated hospitalizations, severe pain, difficulty breathing and restricted mobility. Although diuretics are standard of care, they become ineffective, untolerable or exacerbate the problem in many patients. There are limited effective treatment options, resulting in poor clinical outcomes, high costs and a major impact on their quality of life. Sequana Medical is seeking to provide innovative treatment options for this large and growing "diuretic-resistant" patient population. alfapump® and DSR® are Sequana Medical's proprietary platforms that work with the body to treat diuretic-resistant fluid overload, delivering major clinical and quality of life benefits for patients and reducing costs for healthcare systems. The Company's Premarket Approval (PMA) application for the alfapump was submitted to the US FDA in December 2023 and accepted for substantive review in January 2024, having reported positive primary and secondary endpoint data from the North American pivotal POSEIDON study in recurrent or refractory ascites due to liver cirrhosis. US market approval of the alfapump is anticipated in the second half of 2024. Results of the Company's RED DESERT and SAHARA proof-of-concept studies in heart failure support DSR's mechanism of action as breaking the vicious cycle of cardiorenal syndrome. All three patients from the non-randomized cohort of MOJAVE, a US randomized controlled multi-center Phase 1/2a clinical study, have been successfully treated with DSR, confirming the strong clinical outcomes seen in the RED DESERT and SAHARA studies. The independent Data Safety Monitoring Board approved the start of the randomized MOJAVE cohort of up to a further 30 patients, which is planned after alfapump PMA approval. Sequana Medical is listed on Euronext Brussels (Ticker: SEQUA.BR) and headquartered in Ghent, Belgium. For further information, please visit . Important Regulatory Disclaimers The alfapump® system is currently not approved in the United States or Canada. In the United States and Canada, the alfapump system is currently under clinical investigation (POSEIDON Trial) and is being studied in adult patients with refractory or recurrent ascites due to liver cirrhosis. DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. There is no link between DSR therapy and ongoing investigations with the alfapump system in Europe, the United States or Canada. Note: alfapump® and DSR® are registered trademarks. Forward-looking statements This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent the current judgment of Sequana Medical on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release. Attachments Press release_THT Late breaking abstract_Feb 2024_NL_vF Press release_THT Late breaking abstract_Feb 2024_ENG_vF