Financial Data and Key Metrics Changes - As of September 30, 2025, the company's cash, cash equivalents, and short-term investments were $55.3 million, an increase from $30 million as of June 30, 2025, and $44.1 million at the end of the previous year [14] - The net cash used in operating activities for the nine months ended September 30, 2025, was $21.3 million, compared to $15.6 million for the same period in 2024, primarily due to an increase in net loss [14][15] - The net losses for the three and nine month periods ending September 30, 2025, were $8.6 million and $24.0 million, respectively, higher than the $6.3 million and $16.5 million reported during the same periods in 2024 [17] Business Line Data and Key Metrics Changes - R&D expenses for the three and nine month periods ending September 30, 2025, were $6.4 million and $17.9 million, respectively, an increase from $5 million and $12.6 million in the same periods of the prior year, driven by the progress of the ReMEDy2 clinical trial and the expansion of the clinical team [16] - General and administrative expenses were $2.6 million and $7.3 million for the three and nine month periods ending September 30, 2025, up from $1.9 million and $5.7 million in 2024, attributed to increased non-cash share-based compensation and personnel costs [16][17] Market Data and Key Metrics Changes - The enrollment rates for the ReMEDy2 stroke trial have been lower than initially projected due to changes in stroke referral patterns, with current enrollment approaching 50% of the target for the interim futility analysis [10][11] - The company is currently utilizing actual enrollment rates from clinical trial sites instead of historical rates for more accurate forecasting [11][36] Company Strategy and Development Direction - The company is focusing on advancing its clinical programs, particularly DM199, which is positioned as a first-in-class treatment for preeclampsia and other vascular-related conditions [3][4] - Plans include expanding clinical studies into early onset preeclampsia and fetal growth restriction cohorts, with a U.S. phase two trial anticipated to begin soon [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the current cash position to fund planned clinical studies and operations into the second half of 2027 [14] - The management team remains optimistic about the potential of DM199 based on encouraging interim results and the unique safety profile of the drug [4][22] Other Important Information - The company completed an in-person pre-IND meeting with the FDA, which was deemed productive, and is preparing for a phase two trial in the U.S. [9] - The Independent Data Safety Monitoring Board reported no safety concerns in the ReMEDy2 trial, allowing enrollment to continue without modification [12] Q&A Session Summary Question: Discussion on preeclampsia KOL community engagement and trial site considerations - Management highlighted extensive outreach to KOLs, receiving encouraging feedback regarding DM199's safety profile and efficacy in reducing blood pressure [20][22] Question: Details on protocol amendments and dosing outcomes - Management explained that part 1B will focus on IV dosing until delivery, allowing physicians to adjust dosing as needed based on patient response [23] Question: Clarification on the purpose of the 12 patient expansion cohort - The 12 patient cohort was intended to supplement the original plan for part 1B, focusing on the highest dose observed in cohort 10 [27][28] Question: Expectations for enrollment rates and site activation for the stroke trial - Management noted that historical enrollment rates were around 0.25, but current rates are slightly lower, with over 35 sites activated and more coming on board [35][36] Question: Meaningful change expectations for the modified Rankin Scale score at interim analysis - A 15% absolute improvement in the mRS score is expected to be meaningful, with adjustments made to the protocol to exclude severe stroke patients [42][43]

Financial Data and Key Metrics Changes - The company is in a pivotal phase two/three for ischemic stroke and is simultaneously conducting a phase two study for preeclampsia, with key data expected in the next sixty days [3][34] - The market opportunity for early onset preeclampsia is estimated at about 30,000 patients in the U.S., with a focus on severe cases that require hospitalization [13][14] Business Line Data and Key Metrics Changes - DM199 is a recombinant human tissue kallikrein-1 (KLK1) serine protease enzyme, which has shown potential in increasing perfusion and lowering blood pressure in preeclampsia patients [7][15] - The current treatment options for preeclampsia are described as antiquated and ineffective, highlighting the need for a new therapy like DM199 [14][19] Market Data and Key Metrics Changes - In the U.S., early onset preeclampsia occurs in up to 1% of pregnancies, translating to approximately 40,000 live births annually, indicating a significant market potential for DM199 [13][14] - The company anticipates a high penetration rate for DM199 in the market due to the lack of effective current treatments [13][15] Company Strategy and Development Direction - The company aims to address the unmet need in preeclampsia treatment by providing a therapy that does not cross the placental barrier, thus reducing risks to the fetus [15][19] - The strategy includes leveraging clinical data from existing studies in China to inform the development of DM199 for ischemic stroke and preeclampsia [35][39] Management's Comments on Operating Environment and Future Outlook - Management emphasizes the critical need for effective treatments in preeclampsia, as current medications often fail to manage the disease effectively [19][54] - The company is optimistic about the upcoming data readouts and believes that successful results could validate the efficacy of DM199 in both preeclampsia and ischemic stroke [34][50] Other Important Information - The company is conducting a KOL event on May 28 to discuss the unmet needs in preeclampsia and the design of their clinical trials [58][60] - The pivotal REMEDY two trial for DM199 in acute ischemic stroke is targeting patients who are not eligible for existing treatments, representing a large market opportunity [43][44] Q&A Session Summary Question: Can you discuss the clinical development of DM199 for preeclampsia? - The company is in a pivotal phase two/three for ischemic stroke and simultaneously conducting a phase two study for preeclampsia, with data expected soon [3][34] Question: What is the market opportunity for DM199 in preeclampsia? - The market opportunity is estimated at about 30,000 patients in the U.S., focusing on severe cases that require hospitalization [13][14] Question: Why was South Africa chosen for the preeclampsia trial? - South Africa was selected due to high rates of preeclampsia and the expertise of local investigators in conducting rigorous clinical trials [21][23] Question: What are the key endpoints for the preeclampsia study? - Key endpoints include assessing whether DM199 crosses the placental barrier and its efficacy in lowering blood pressure [30][31] Question: How does DM199 compare to existing treatments for stroke? - DM199 has a 24-hour treatment window, which is significantly longer than existing treatments, potentially allowing more patients to receive effective care [47][49]