DiaMedica Therapeutics(US:DMAC)2022-08-11 16:01Financial Data and Key Metrics Changes - As of June 30, 2022, the company's combined cash and investments totaled $38.4 million, down $2.6 million from $41 million at the end of Q1 2022 and down $6.7 million from $45.1 million at the prior year-end [18] - Research and development expenses for Q2 were $2 million, compared to $2.2 million in the same period last year, while year-to-date expenses were $3.9 million versus $4.6 million in the prior year [20] - General and administrative expenses for Q2 were $1.4 million, up from $1.2 million in the same period last year, with year-to-date expenses at $3 million compared to $2.4 million previously [22] Business Line Data and Key Metrics Changes - The enrollment in the ReMEDy2 stroke trial was paused due to three incidents of clinically significant hypotension, which were not reported in the prior Phase II ReMEDy1 trial [3][5] - The company plans to propose a revision of IV dose levels to match those in the ReMEDy1 trial, where DM199 was well tolerated [12] Market Data and Key Metrics Changes - The company noted that there were no similar hypotensive events reported with subcutaneous dosing, indicating that the issue was related to the IV bag used in the ReMEDy2 trial [15] Company Strategy and Development Direction - The company is focused on addressing the clinical hold imposed by the FDA and plans to submit a response in September, with the hope of resuming enrollment shortly thereafter [13][24] - The company aims to adjust the dosing strategy based on findings from the IV bag compatibility study, which indicated that the previous IV bags caused significant binding of the DM199 protein [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence that the hypotensive events were related to the IV bag change rather than a problem with DM199 itself, suggesting that the drug is biologically active [14] - The company remains optimistic about resuming the trial and believes that adequate clinical monitoring can mitigate risks associated with hypotension [16] Other Important Information - The company highlighted that cash usage was lower than planned due to the enrollment halt, but current cash reserves are expected to support operations into early 2024 [19] Q&A Session Summary Question: How variable was the drug binding to the IV bag? - Management indicated that the binding was dependent on patient body weight, and they plan to drop the dosing in half to 0.5 micrograms per kg for all patients [26] Question: How have site activation discussions proceeded during the hold? - Management has maintained communication with sites and continued pre-activation activities, including budget discussions and staffing assessments [27] Question: How was enrollment pacing before the hold? - Management noted that enrollment was slow initially but showed a significant uptick in the month prior to the hold, indicating positive momentum [28] Question: Were there any issues with the IV bags during the Phase II trial? - Management acknowledged that binding was noted in earlier trials but deemed it not significant at that time [31] Question: What are the potential outcomes from the FDA feedback? - Management believes the issue is solely related to the IV bag and plans to adjust the dose accordingly, aiming for a clear path to lift the clinical hold [50]