Financial Data and Key Metrics Changes - As of March 31, 2025, the company reported total combined cash and investments of $37.3 million, down from $44.1 million as of December 31, 2024, indicating a decrease due to net cash used to fund operations [11] - Current liabilities were reported at $4.7 million, compared to $5.4 million in the previous quarter, while working capital decreased to $32.8 million from $39.2 million [11] - Net cash used in operating activities for Q1 2025 was $7.1 million, an increase from $6.7 million in Q1 2024, primarily due to an increased net loss [12] Business Line Data and Key Metrics Changes - Research and development expenses increased to $5.7 million for Q1 2025, up from $3.7 million in Q1 2024, driven by costs associated with the REMEDY two clinical trial and global expansion [12][13] - General and administrative expenses rose to $2.5 million from $2.1 million, mainly due to additional non-cash share-based compensation [13] Market Data and Key Metrics Changes - The company is currently engaged in two clinical development programs: preeclampsia and stroke, with significant progress reported in both areas [4][8] - Enrollment for the stroke program is progressing steadily, with participant enrollment now between the 20th and 25th percentile mark for the interim analysis [9] Company Strategy and Development Direction - The company aims to advance its clinical development programs, particularly focusing on the preeclampsia program, which is currently the only novel agent being studied in pregnant women with this condition [8] - The management is also working on expanding the stroke program's enrollment and maintaining momentum through site engagement [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in both clinical programs and highlighted the importance of upcoming milestones, including preliminary results from the preeclampsia trial and interim analysis from the stroke program [43] - The company anticipates that its current cash and investments will provide a runway into Q3 2026, indicating a focus on sustaining operations while advancing clinical trials [12] Other Important Information - A key opinion leader call regarding preeclampsia is scheduled for May 28, 2025, to educate stakeholders about the disease and the company's clinical trial design [6][8] - The company is actively engaging with high-volume sites to drive enrollment in the stroke program, with a focus on maintaining relationships and expanding geographic reach [33] Q&A Session Summary Question: Clarification on laboratory test results for DM199 - Management confirmed that the main variable affecting the timeline for results is the placental transfer assay, which is being finalized [17] Question: Triggers for Parts 2 and 3 of the preeclampsia study - Management indicated that dilation of intrauterine arteries would trigger the fetal growth restriction cohort, with more details to be shared after upcoming results [19][20] Question: Anticipated read-through from preeclampsia data to AIS development - Management noted that while the indications are unique, positive results in preeclampsia would confirm the activity of the protein being studied [25] Question: Update on stroke program enrollment - Management reported that high-enrolling sites are seeing one to two patients per month, and overall enrollment is above plan, with encouraging momentum [31][32] Question: Expansion of the preeclampsia study to the U.S. - Management confirmed plans to expand the study to the U.S. in the future, but the current focus remains on completing Part 1a and moving into Part 1b [39]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company reported total combined cash and investments of $37.3 million, down from $44.1 million as of December 31, 2024, indicating a decrease due to net cash used to fund operations [10] - Current liabilities decreased to $4.7 million from $5.4 million, while working capital fell to $32.8 million from $39.2 million [10] - Net cash used in operating activities for Q1 2025 was $7.1 million, compared to $6.7 million for Q1 2024, reflecting an increase in net loss [11] Business Line Data and Key Metrics Changes - Research and development expenses increased to $5.7 million for Q1 2025, up from $3.7 million in Q1 2024, primarily due to costs associated with the REMEDY two clinical trial and global expansion [11][12] - General and administrative expenses rose to $2.5 million from $2.1 million, mainly due to additional non-cash share-based compensation [12] Market Data and Key Metrics Changes - The company is currently engaged in two clinical development programs: preeclampsia and stroke, with significant progress reported in both areas [4][8] - Enrollment for the stroke program is progressing steadily, with participant enrollment now between the 20th and 25th percentile mark for the interim analysis [8] Company Strategy and Development Direction - The company aims to advance its clinical development programs, particularly focusing on the preeclampsia program, which is expected to release preliminary top-line results between June and July [5][6] - The company plans to sponsor a preeclampsia key opinion leader call to educate stakeholders on the disease and treatment options [6][7] - Future expansion of the preeclampsia study to the U.S. is planned, with a focus on obtaining results from Part 1a before moving to Parts 1b, 2, and 3 [36] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in both the preeclampsia and stroke programs, highlighting the importance of upcoming milestones [39] - The company anticipates that its current cash and investments will provide a runway into Q3 2026, indicating a stable financial position for ongoing operations [11] Other Important Information - The company has engaged an experienced stroke neurologist to support site engagement during a key team member's medical leave, ensuring continued enrollment momentum [8] Q&A Session Summary Question: Clarification on laboratory test results timing - Management confirmed that the main variable affecting the timing of results is the placental transfer assay, which is being finalized [15][16] Question: Triggers for advancing to Part 2 and 3 of the preeclampsia study - Management indicated that dilation of intrauterine arteries would trigger movement to the fetal growth restriction cohort [17][18] Question: Anticipated read-through from preeclampsia data to stroke development - Management noted that positive preeclampsia data would confirm the activity of the protein being studied, which is also used in stroke treatment [22][24] Question: Update on stroke program enrollment and high-volume centers - Management reported that some high-enrolling sites are achieving one to two patients per month, with overall enrollment momentum building [26][28] Question: Future expansion of the preeclampsia study to the U.S. - Management confirmed plans to expand the study to the U.S. in the future, contingent on results from the current phases [34][36]

Financial Performance - For the three months ended March 31, 2025, the net loss was $7.7 million, compared to a net loss of $5.2 million for the same period in 2024, resulting in an accumulated deficit of $147.7 million as of March 31, 2025[72]. - Other income, net, decreased to $443 thousand for the three months ended March 31, 2025, compared to $597 thousand for the same period in 2024, due to reduced interest income from lower average marketable securities balances[81]. - The net cash used in operating activities for the three months ended March 31, 2025, was $7.1 million, an increase from $6.7 million for the same period in 2024, representing a rise of approximately 6.0%[84]. - The company reported net cash provided by financing activities of $91 thousand for the three months ended March 31, 2025, a significant improvement from a net cash outflow of $1 thousand in the same period of 2024[86]. Research and Development - Research and development (R&D) expenses increased to $5.7 million for the three months ended March 31, 2025, up from $3.7 million for the same period in 2024, primarily due to the continuation of the ReMEDy2 clinical trial and increased manufacturing development activity[79]. - The ReMEDy2 clinical trial aims to enroll approximately 300 participants at up to 100 sites globally, with an adaptive design that includes an interim analysis after the first 200 participants[71]. - The Phase 2 study for preeclampsia (PE) is expected to evaluate up to 90 women, with preliminary topline results anticipated between June and July 2025[69]. - DM199 has received Fast Track designation from the FDA for the treatment of acute ischemic stroke (AIS) and is the first recombinant form of KLK1 undergoing global clinical development[64]. Cash and Liquidity - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $37.3 million, down from $44.1 million as of December 31, 2024, reflecting a decrease of approximately 15.5%[82][83]. - The company anticipates that its current cash resources will be sufficient to fund operations for at least the next 12 months, although future funding requirements may arise earlier than expected[74]. - The company may require significant additional funds earlier than currently expected, particularly if market conditions for raising capital are favorable[88][90]. Operating Expenses - General and administrative (G&A) expenses were $2.5 million for the three months ended March 31, 2025, compared to $2.1 million for the same period in 2024, driven by additional non-cash share-based compensation expenses[80]. - Future operating losses are expected to increase moderately as the company continues its clinical trials and expands its team to support operations[73]. - The company anticipates needing substantial additional capital to complete R&D activities and expects operating losses to moderately increase in the near term[88]. Funding and Capital Requirements - The company has not generated any revenues from product sales and has financed operations primarily through equity sales, interest income, and government grants[72]. - The company has not generated any revenues from product sales and does not expect to do so for at least three to four years, indicating ongoing reliance on external funding[87]. - The most recent equity financing raised gross proceeds of $11.8 million from the issuance of 4,720,000 common shares at $2.50 per share, approximately 10% above the closing price on the offering date[89]. - If adequate funding is not available, the company may need to implement cost reduction strategies, including potential layoffs or scaling back development efforts[91].

Financial Performance - Net loss for Q1 2025 was $7.7 million, or $0.18 loss per share, compared to a net loss of $5.2 million, or $0.14 loss per share, in Q1 2024[8] - For the three months ended March 31, 2025, the net loss was $7,707,000, compared to a net loss of $5,151,000 for the same period in 2024, representing a 49% increase in net loss year-over-year[19] - The company reported a basic and diluted net loss per share of $0.18 for Q1 2025, compared to $0.14 for Q1 2024, reflecting a 29% increase in loss per share[19] Cash and Investments - Cash, cash equivalents, and short-term investments were $37.3 million as of March 31, 2025, down from $44.1 million as of December 31, 2024[8] - The company anticipates its current cash position will fund planned clinical studies and support operations into Q3 2026[8] - Cash and cash equivalents at the end of the period were $2,589,000, down from $3,025,000 at the beginning of the period, a decrease of 14%[23] - The company experienced a net cash provided by investing activities of $6,622,000 in Q1 2025, compared to $4,208,000 in Q1 2024, an increase of 57%[23] Operating Activities - Net cash used in operating activities for Q1 2025 was $7.1 million, compared to $6.7 million for the same period in 2024, reflecting an increase in net loss[8] - Net cash used in operating activities was $7,149,000 for Q1 2025, compared to $6,653,000 for Q1 2024, indicating a 7% increase in cash outflow[23] Research and Development - Research and Development (R&D) expenses increased to $5.7 million in Q1 2025 from $3.7 million in Q1 2024, primarily due to the continuation of the ReMEDy2 clinical trial and global expansion[8] - Research and development expenses increased to $5,656,000 in Q1 2025 from $3,676,000 in Q1 2024, reflecting a 54% increase[19] - Enrollment in the Phase 2/3 ReMEDy2 trial for acute ischemic stroke is progressing as planned, with an interim analysis on the first 200 patients expected in the first half of 2026[5] - The Phase 2 trial for DM199 in preeclampsia will enroll up to 90 women with preeclampsia and 30 women with fetal growth restriction[10] Administrative Expenses - General and Administrative (G&A) expenses rose to $2.5 million in Q1 2025 from $2.1 million in Q1 2024, mainly due to additional non-cash share-based compensation[8] Assets and Liabilities - Total current assets decreased to $37,422,000 as of March 31, 2025, down from $44,610,000 as of March 31, 2024, a decline of 16%[21] - Total assets decreased to $38,830,000 as of March 31, 2025, compared to $46,345,000 as of December 31, 2024, a decrease of 16%[21] - Total liabilities decreased to $4,876,000 as of March 31, 2025, down from $5,627,000 as of December 31, 2024, a decrease of 13%[21] Upcoming Events - A virtual key opinion leader (KOL) event is scheduled for May 28, 2025, to discuss the treatment landscape for preeclampsia and the DM199 Phase 2 study design[4] Clinical Study Results - Topline safety and efficacy results from Part 1A of the Phase 2 preeclampsia study are expected between the second half of June and the first half of July 2025[2]

Financial Data and Key Metrics Changes - As of December 31, 2024, the company reported total combined cash and investments of $44.1 million, down from $52.9 million at the end of 2023, indicating a decrease due to cash used for operations [34] - Current liabilities increased to $5.4 million from $2.8 million, while working capital decreased to $39.2 million from $50.9 million [34] - Net cash used in operating activities for the full year 2024 was $22.1 million, compared to $18.7 million in 2023, driven by increased net loss and advance deposit funds for the ReMEDy2 trial [35] Business Line Data and Key Metrics Changes - Research and development expenses rose to $19.1 million for the year ended December 31, 2024, up from $13.1 million in the prior year, primarily due to the continuation of the ReMEDy2 clinical trial and increased manufacturing activities [36] - General and administrative expenses decreased to $7.6 million from $8.2 million, attributed to reduced legal fees and lower insurance premiums, partially offset by increased personnel costs [38] Market Data and Key Metrics Changes - The company activated 30 clinical sites for the ReMEDy2 trial, which is expected to generate a steady stream of enrollments [16] - The protocol for the stroke program was updated to allow DM199 to be stored at refrigerated temperatures, expanding the eligible patient population [17] Company Strategy and Development Direction - The company is focused on advancing its clinical programs for DM199 in both stroke and preeclampsia, aiming to provide treatment options for conditions with no current therapeutic alternatives [31][78] - The strategy includes expanding the ReMEDy2 trial globally and increasing site activation and enrollment activities [37] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in clinical trials and the potential of DM199 as a transformative therapy for patients lacking treatment options [78] - The company anticipates that its current cash and investments will provide a runway into Q3 of 2026, indicating a stable financial outlook for the near term [36] Other Important Information - The independent Data Safety Monitoring Board reviewed safety data and concluded that the ReMEDy2 trial should continue without modification [27] - A peer-reviewed publication analyzing DM199's mechanism of action was released, providing scientific insight into its potential benefits for acute ischemic stroke patients [28] Q&A Session Summary Question: How many of the activated sites are among the top 15 identified? - The majority of the top 15 sites are activated, with many currently enrolling patients [43] Question: What data did the DSMB review for safety? - The DSMB had access to the entire database of patient data up until a specific cutoff date [45] Question: What are the expectations around enrollment rates for the ReMEDy2 trial? - The company anticipates doubling the number of enrolling sites and expects sites to enroll about one to two patients per month [55] Question: Has the amended statistical analysis plan been finalized with the FDA? - Yes, the amended statistical analysis plan has been finalized with the FDA [74]

Financial Data and Key Metrics Changes - As of December 31, 2024, the company reported total combined cash and investments of $44.1 million, down from $52.9 million at the end of 2023, indicating a decrease due to cash used for operations [34] - Current liabilities increased to $5.4 million from $2.8 million, while working capital decreased to $39.2 million from $50.9 million [34] - Net cash used in operating activities for the full year 2024 was $22.1 million, compared to $18.7 million in 2023, driven by increased net loss and advance deposit funds to vendors [35] Business Line Data and Key Metrics Changes - Research and development expenses rose to $19.1 million for the year ended December 31, 2024, up from $13.1 million in the prior year, primarily due to the continuation of the ReMEDy2 clinical trial and increased manufacturing activities [36] - General and administrative expenses decreased to $7.6 million from $8.2 million, attributed to reduced legal fees and lower insurance premiums, partially offset by increased personnel costs [38] Market Data and Key Metrics Changes - The company activated 30 clinical sites for the ReMEDy2 trial, which is expected to generate a steady stream of enrollments [16] - The protocol for the stroke program was updated to allow DM199 to be stored at refrigerated temperatures, expanding the eligible patient population [17] Company Strategy and Development Direction - The company is focused on advancing its clinical programs for DM199 in both stroke and preeclampsia, aiming to provide treatment options for conditions currently lacking effective therapies [31][78] - The strategy includes expanding the ReMEDy2 trial globally and increasing site activation and enrollment activities [37] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in site engagement and enrollment due to lower staffing levels in research units post-COVID, but expressed optimism about increasing enrollment rates in 2025 [22][24] - The company anticipates that its current cash and investments will provide a runway into Q3 of 2026, indicating a stable financial outlook for the near term [36] Other Important Information - The independent Data Safety Monitoring Board reviewed safety data and concluded that the ReMEDy2 trial should continue without modification [27] - A recent publication analyzed the mechanism of action of DM199, providing scientific insight into its potential benefits for acute ischemic stroke patients [28] Q&A Session Summary Question: How many of the activated sites are among the top 15 identified? - The majority of the top 15 sites are activated, with many currently enrolling patients [43] Question: What data did the DSMB review for safety? - The DSMB had access to the entire database of patient data up until a specific cutoff date [45] Question: What are the expectations around enrollment rates for the interim analysis? - The company anticipates doubling the number of enrolling sites and targeting sites that can enroll about one to two patients per month [55] Question: Has the amended statistical analysis plan been finalized with the FDA? - Yes, the amended statistical analysis plan has been finalized with the FDA [74]

Financial Performance - DiaMedica Therapeutics Inc. reported net losses of $24.4 million and $19.4 million for the years ended December 31, 2024 and 2023, respectively[375]. - The company had cash, cash equivalents, and marketable securities of $44.1 million as of December 31, 2024, with an accumulated deficit of $140.0 million[375]. - General and administrative (G&A) expenses decreased to $7.6 million in 2024 from $8.2 million in 2023[379]. - Other income, net, increased to $2.3 million in 2024 from $1.9 million in 2023, driven by higher interest income related to increased marketable securities[393]. - Cash, cash equivalents, and marketable securities decreased to $44.1 million as of December 31, 2024, from $52.9 million in 2023, due to net cash used in operating activities[396]. - Net cash used in operating activities was $22.1 million for 2024, compared to $18.7 million in 2023, primarily due to increased net loss and advance deposit funds for the ReMEDy2 trial[397]. - Net cash provided by financing activities was $12.0 million in 2024, down from $36.8 million in 2023, mainly from the June 2024 private placement[399]. - The company expects to incur substantial operating losses until product sales or licensing fees are generated, with operating losses expected to moderately increase as clinical studies continue[401]. - As of December 31, 2024, the company estimates outstanding commitments of approximately $19.3 million, with $14.5 million due within the next 12 months[406]. - Future operating lease obligations total approximately $316,000, with about $90,000 due over the next 12 months[407]. - The company does not expect to generate any revenue from product sales for at least three to four years, pending regulatory approvals[401]. Research and Development - Research and development (R&D) expenses were $19.1 million for 2024, up from $13.1 million in 2023, primarily due to clinical development costs[378]. - Research and development (R&D) expenses increased to $19.1 million for the year ended December 31, 2024, up from $13.1 million in 2023, primarily due to the continuation of the ReMEDy2 clinical trial and expansion of the clinical team[391]. - The ReMEDy2 clinical trial for DM199 aims to enroll approximately 300 participants globally, with a potential final sample size of up to 728 patients[367]. - The Phase 2 trial for preeclampsia (PE) is expected to evaluate up to 90 women, with results from the initial part anticipated in Q2 2025[371]. - DM199 is designed to enhance blood flow and neuronal survival in AIS patients, addressing a critical unmet need as up to 80% of AIS patients are ineligible for current treatments[366]. - The company expects to incur significant expenses and increased operating losses for at least the next few years as it expands its clinical trials[376]. - The company plans to continue monitoring and potentially expanding its clinical development programs based on ongoing results and market conditions[377]. Licensing and Obligations - The company has entered into a license agreement with Catalent Pharma Solutions for gene expression technology and manufacturing of DM199[408]. - A milestone payment obligation remains due upon the first regulatory approval of DM199 for commercial sale as of December 31, 2024[408]. - Following the product launch, the company will incur a royalty obligation of less than 1% of net sales, with an indefinite royalty term[408]. - The license agreement can be canceled by the company with 90 days' prior written notice[408]. - Catalent cannot terminate the license unless the company fails to make required milestone and royalty payments[408].

Financial Position - Cash position as of December 31, 2024, was $44.1 million, down from $52.9 million as of December 31, 2023, with a cash runway anticipated into Q3 2026[7] - Total assets decreased from $54,160 million in 2023 to $46,345 million in 2024, a decline of approximately 14.9%[19] - Current liabilities increased significantly from $2,786 million in 2023 to $5,390 million in 2024, an increase of about 93%[19] - Shareholders' equity dropped from $51,057 million in 2023 to $40,718 million in 2024, a decrease of approximately 20.2%[19] - Cash and cash equivalents decreased from $4,543 million at the beginning of the period to $3,025 million at the end, a decline of 33.4%[21] - Total current assets fell from $53,675 million in 2023 to $44,610 million in 2024, a decrease of approximately 16.9%[19] - The company reported an increase in accrued liabilities from $1,777 million in 2023 to $4,347 million in 2024, an increase of about 144.5%[19] Operating Activities - Net cash used in operating activities for 2024 was $22.1 million, an increase from $18.7 million in 2023, primarily due to increased net loss and advance deposits for the ReMEDy2 trial[7] - Net cash used in operating activities was $22,076 million in 2024, compared to $18,728 million in 2023, indicating a 17.9% increase in cash outflow[21] Research and Development - Research and Development (R&D) expenses rose to $19.1 million in 2024 from $13.1 million in 2023, driven by the continuation of the ReMEDy2 trial and expansion of the clinical team[7] - The company expects moderate increases in R&D expenses as it expands the ReMEDy2 trial and the DM199 clinical development program into preeclampsia[7] Net Loss - Net loss for the year ended December 31, 2024, was $24.4 million, or $0.60 loss per share, compared to a net loss of $19.4 million, or $0.60 loss per share, in 2023[7] - Net loss for 2024 was $24,444 million, compared to a net loss of $19,381 million in 2023, representing a 26.5% increase in losses[21] ReMEDy2 Trial - The ReMEDy2 trial has activated 30 study sites as of Q1 2025, with an interim analysis for sample size re-estimation expected in the first half of 2026[3] - The ReMEDy2 trial aims to enroll approximately 300 patients globally, with the final sample size determined by an interim analysis of 200 participants[10] - Preliminary safety and efficacy data from the Phase 2 trial for preeclampsia is anticipated in Q2 2025[4] Corporate Developments - The company appointed Daniel J. O'Connor to the Board in February 2025, who previously led a $2 billion acquisition at Ambrx[6] Cash Flows - Cash flows from investing activities improved, with net cash provided of $8,564 million in 2024 compared to a net cash used of $18,299 million in 2023[21] - Proceeds from the issuance of common shares decreased from $36,848 million in 2023 to $11,747 million in 2024, a decline of about 68.2%[21]

Financial Data and Key Metrics Changes - As of September 30, 2024, the company's cash, cash equivalents, and investments totaled $50.2 million, down from $52.9 million as of December 31, 2023 [30] - Net cash used in operating activities for the nine months ended September 30, 2024, was $15.6 million compared to $14.9 million in the same period of the prior year [30] - Research and development expenses increased to $5 million for the three months ended September 30, 2024, up from $3.3 million in the prior year period [31] - General and administrative expenses were $1.9 million for each of the three months ended September 30, 2024, and 2023 [33] Business Line Data and Key Metrics Changes - The company is making solid progress on its stroke and preeclampsia programs, with expectations for 2025 to be transformative [4] - The ReMEDy2 trial is seeing updates to its protocol and statistical analysis plan to enhance enrollment rates and improve trial outcomes [11][12] Market Data and Key Metrics Changes - The company anticipates that the activation of top U.S. sites for the AIS study will lead to a significant increase in patient enrollment [5][6] - The preeclampsia program has secured regulatory approval in South Africa, with the first participant enrolled [9] Company Strategy and Development Direction - The company is focused on building momentum with high-quality research institutions and expanding its clinical trial sites [28] - The updates to the ReMEDy2 trial are expected to improve the probability of success and accelerate the timeline for completion [16][28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of DM199 in treating preeclampsia and its first and best-in-class potential [9] - The company believes that the changes in the ReMEDy2 trial will lead to a more efficient study and significant cost savings [27] Other Important Information - The company expects its current cash and investments to provide a runway to Q3 of 2026 [30] - The interim analysis for the ReMEDy2 trial is now expected in Q4 2025, with completion anticipated by next summer [50] Q&A Session Summary Question: What prompted the re-evaluation of the ReMEDy2 protocol? - The changes were driven by a combination of wanting to simulate enrollment and extensive discussions with experts [37] Question: At what point will patients now be randomized? - Patients will be randomized into the study only if they do not receive tPA prior to randomization [38] Question: Is the total number of patients for the study still viable? - The total number of patients is expected to be lower than the previously planned 364 based on the new interim analysis [39] Question: What are the assumptions for a quicker final readout with the changes? - The changes allow for greater precision in sample size assessment, potentially reducing the total number of patients needed [42] Question: Will the changes impact DM199's commercial opportunity? - The company believes that expanding the label to include tPA non-responders could significantly increase the patient population and revenue potential [48] Question: Is there any risk of FDA feedback necessitating trial modifications? - The chances of receiving substantive FDA feedback are low at this point, as the company is well past the 30-day mark for comments [55]

Financial Performance - For the nine months ended September 30, 2024, the net loss was $16.5 million, compared to $14.2 million for the same period in 2023, reflecting an increase in losses due to ongoing clinical trials and operational costs[68]. - The company has an accumulated deficit of $132.1 million as of September 30, 2024, with substantial operating losses primarily from product candidate development and R&D activities[68]. - General and administrative expenses were $1.9 million for the three months ended September 30, 2024, consistent with the same period in 2023, while for the nine months, expenses decreased to $5.68 million from $5.99 million[79]. - Net cash used in operating activities was $15.6 million for the nine months ended September 30, 2024, compared to $14.9 million for the same period in 2023, indicating an increase of approximately 4.7%[84]. - The company expects to incur significant expenses and increased operating losses for at least the next several years as it expands its clinical trials and development programs[69]. - The company expects to incur substantial operating losses as it continues research and development of its DM199 product candidate, with no revenue expected for at least three to four years[87]. Research and Development - Research and development expenses increased to $4.98 million for the three months ended September 30, 2024, up from $3.27 million for the same period in 2023, and to $12.59 million for the nine months ended September 30, 2024, up from $9.43 million in 2023[78]. - The ReMEDy2 clinical trial aims to enroll approximately 350 patients globally, with a potential sample size adjustment based on interim analysis results[63]. - The company received regulatory approval to initiate a study of DM199 for the treatment of preeclampsia, which affects up to 8% of pregnancies worldwide[65]. - The first subject in the investigator-sponsored study of DM199 for preeclampsia was enrolled in Q4 2024, with topline data expected to demonstrate initial proof-of-concept[67]. Cash and Liquidity - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $50.2 million, down from $52.9 million as of December 31, 2023, representing a decrease of approximately 5.1%[81]. - The company anticipates that its current cash resources will be sufficient to fund operations for at least the next 12 months, although future funding requirements may arise sooner than expected[71]. - Total current liabilities increased to $4.3 million as of September 30, 2024, compared to $2.8 million at the end of 2023, marking a rise of about 53.6%[81]. - Net cash provided by investing activities was $3.4 million for the nine months ended September 30, 2024, a significant improvement from a net cash outflow of $24.4 million in the same period of 2023[85]. - Net cash provided by financing activities decreased to $11.9 million for the nine months ended September 30, 2024, down from $36.8 million in the prior year, a decline of approximately 67.6%[86]. - The company anticipates needing substantial additional capital to support ongoing R&D activities and clinical studies, with current cash resources expected to last for at least the next twelve months[88]. - Future funding requirements will depend on various factors, including the timing and results of ongoing development efforts and the potential expansion of current programs[88]. - The company has historically financed operations primarily through equity sales and expects to continue this practice, with no existing credit facilities available[90]. - If adequate funding is not available, the company may need to scale back operations, which could include cost reduction strategies and potential divestitures[92].