On May 15, 2023 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, reported a business update and financial results for the quarter ended March 31, 2023 (Press release, DiaMedica, MAY 15, 2023, View Source [SID1234631714]). Management will host a conference call Tuesday, May 16, 2023, at 7:00AM Central Daylight Time/8:00AM Eastern Daylight Time to discuss its business update and first quarter 2023 financial results.
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Clinical Developments
ReMEDy2 Phase 2/3 Trial for Acute Ischemic Stroke – Clinical Hold Update
DiaMedica plans to file complete response requesting hold lift this week
DiaMedica plans to file a clinical hold response with the U.S. Food and Drug Administration (FDA) by the end of the week. This request for lifting the clinical hold will include the submission of requested additional supporting data to address prior issues that led to the clinical hold in July 2022. DiaMedica has completed supplemental in-use studies as requested by the FDA. These studies, performed at an independent laboratory, were conducted in two parts. Part 1 simulated actual use of DM199 administration in a hospital setting and Part 2 evaluated worst-case scenarios such as varying storage durations, temperature(s) and light exposure to DM199. DiaMedica believes data from Part 1 confirmed its conclusions from prior testing that the intravenous (IV) dose administered in the ReMEDy2 study was higher than planned due to the change in IV bag materials and was the cause of the hypotension. Accordingly, a dose revision in ReMEDy2 from 1.0 µg/kg to 0.5 µg/kg should avoid or minimize the risk of clinically significant hypotension while still reaching what we believe will be a therapeutic blood concentration level. Additionally, results from part 2 of the in-use study were substantially consistent with Part 1 indicating that no special handling instructions should be required. These results are also similar to the Company’s IV bag study completed in the fall of 2022. The Company further notes that there are no proposed changes to the ensuing three weeks of subcutaneous dosing under the study protocol.
As previously announced, the Company provided responses to FDA inquiries on a potential trypsin impurity contributing to hypotension and methods assays to be used to measure results in the in-use study. The FDA responded to the Company indicating that the assays developed for the in-use study appeared appropriate and its assessment of the potential trypsin impurity was also acceptable.
"With the pending submission of our request to lift the clinical hold, we are optimistic that we have fully identified the cause for last year’s unexpected hypotensive events and have provided the FDA with adequate data to support our position and allow the FDA to lift the clinical hold," commented Rick Pauls, DiaMedica’s Chief Executive Officer. "We look forward to receiving the FDA’s response and hope to then be able to resume our work advancing the science of stroke care."
DiaMedica also completed, in healthy volunteers, a Phase 1C open label, single ascending dose (SAD) study of DM199, administered with the polyvinylchloride (PVC) IV bags used in the ReMEDy2 trial. The purpose of the study was to confirm, with human data, that the revised IV dose of DM199, 0.5 µg/kg, was well-tolerated in humans and achieved an appropriate DM199 blood concentration level similar to prior clinical trials and in the desired therapeutic range. The results from this study will be included as additional supporting data in the Company’s clinical hold response package to the FDA.
"Patient safety is paramount for DiaMedica and we’re pleased to go above and beyond to achieve that end," stated Kirsten Gruis, M.D., DiaMedica’s Chief Medical Officer. "Data developed in our Phase 1C study at the 0.5 µg/kg IV dose level has demonstrated similar DM199 exposure with the IV dosing regimen used in our ReMEDy1 AIS trial. These results, in addition to the in-use study, give us further assurance that we have identified the correct DM199 IV dose level and we hope that this will also give confidence to physician investigators once we are able to resume the ReMEDy2 trial."
Balance Sheet and Cash Flow
DiaMedica reported total cash, cash equivalents and investments of $28.7 million, current liabilities of $2.8 million and working capital of $26.9 million as of March 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 decreases in cash and investments and in working capital were due primarily to cash used to fund operating activities during the quarter ended March 31, 2023. After the end of the quarter, DiaMedica received $750,000 from a private investment from its newly appointed Chief Business Officer.
Net cash used in operating activities for the three months ended March 31, 2023 was $5.1 million compared to $3.9 million for the three months ended March 31, 2022. The increase in cash usage relates primarily to the increased net loss in the current year period over the prior year period, partially offset by non-cash share-based compensation and the effects of changes in operating assets and liabilities in the current year period.
Financial Results
Research and development (R&D) expenses increased to $3.6 million for the three months ended March 31, 2023, up $1.6 million from $2.0 million for the three months ended March 31, 2022. The increased costs were driven by a number of factors, including primarily increased manufacturing and process development costs, the costs for the in-use study performed to address the clinical hold on the IND for the ReMEDy2 trial, costs incurred for the Phase 1C health volunteer study and increased personnel costs associated with expansion of the clinical team. These increases were partially offset by decreased costs incurred in the Phase 2/3 ReMEDy2 trial due to the clinical hold.
General and administrative (G&A) expenses were $1.9 million for the three months ended March 31, 2023, up from $1.6 million for the three months ended March 31, 2022. The increase was primarily due to recruiting costs incurred in conjunction the expansion of the Company’s team and increased legal fees incurred in connection with the Company’s lawsuit against Pharmaceutical Research Associates Group B.V., which was acquired by and is now a subsidiary of ICON plc.
Conference Call and Webcast Information
DiaMedica Management will host a conference call and webcast to discuss its business update and first quarter 2023 financial results on Tuesday, May 16, 2023, at 8:00 AM Eastern Time / 7:00 AM Central Time:
Date:
Tuesday, May 16, 2023
Time:
7:00 AM CT / 8:00 AM ET
Web access:
Dial In:
(877) 550-1858
Conference ID:
2125#
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 play back 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 May 23, 2023, by dialing (800) 645-7964 (US 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 75 sites in the United States. 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. The study population is representative of the approximately 80% of AIS patients who do not have treatment options today, primarily due to the limitations on treatment with tPA 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 (KLK1). KLK1 is a serine protease (protein) that plays an important role in the regulation of diverse physiological processes including blood flow, inflammation, fibrosis, oxidative stress and neurogenesis via a molecular mechanism that increases production of nitric oxide and prostaglandin. 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 a recombinant form of the KLK1 protein. The KLK1 protein, produced from the pancreas of pigs and human urine, has been used to treat patients in Japan, China and South Korea for decades. DM199 is currently being studied in patients with acute ischemic stroke (AIS) and patients with chronic kidney disease. In September 2021, the FDA granted Fast Track Designation to DM199 for the treatment of AIS.