Workflow
DiaMedica Therapeutics(DMAC)
icon
Search documents
DiaMedica Therapeutics(DMAC) - 2024 Q2 - Earnings Call Transcript
2024-08-11 11:31
Financial Data and Key Metrics Changes - The company completed an $11.8 million private placement, extending its cash runway into Q3 of 2026, with net proceeds of approximately $11.7 million [15] - As of June 30, 2024, combined cash, cash equivalents, and investments increased to $54.1 million, up from $52.9 million at the end of 2023 [15] - Net cash used in operating activities for the first half of 2024 was $11.2 million, compared to $10.1 million in the same period of the prior year [16] - Research and development expenses rose to $3.9 million for Q2 2024, up from $2.5 million in Q2 2023, and $7.6 million for the first half of 2024, compared to $6.2 million in the same period of 2023 [16][17] - General and administrative expenses decreased to $1.7 million for Q2 2024, down from $2.2 million in Q2 2023, and $3.8 million for the first half of 2024, down from $4.1 million in the same period of 2023 [18] Business Line Data and Key Metrics Changes - The ReMEDy2 trial is progressing well, with a focus on activating high-quality research institutions [4][8] - The company has identified 15 sites with high enrollment potential, expecting at least 9 of these to be active by the end of Q3 2024 [6][8] Market Data and Key Metrics Changes - The preeclampsia program is gaining momentum, with expectations for initial enrollment to begin in Q4 2024 and top-line results anticipated in the first half of 2025 [13] Company Strategy and Development Direction - The company is focused on expanding the ReMEDy2 trial and engaging with high-quality research sites to facilitate participant enrollment [4][8] - DM-199 is being positioned as a potential first-in-class treatment for preeclampsia, with significant benefits anticipated for patients [9][12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress of the ReMEDy2 trial and the potential of DM-199 in treating preeclampsia, highlighting the lack of approved therapeutic options in this area [8][12] - The company is addressing challenges related to site activation and participant enrollment due to staffing shortages at research hospitals [5][6] Other Important Information - The company is working with a highly experienced research team for the preeclampsia program, which is expected to enhance the study's credibility and effectiveness [10][11] Q&A Session Summary Question: How many sites are currently active and enrolling? - The company has 13 sites activated, with expectations to have 9 out of the 15 high-enrolling sites operational by the end of Q3 [20] Question: How is the regulatory process for the preeclampsia study going? - The regulatory process in South Africa is being led by Dr. Cluver and her team, and it appears to be progressing well [21] Question: Are there any unexpected issues with the screening criteria? - The company feels confident about the screening process and is continuously looking for ways to improve enrollment rates [22]
DiaMedica Therapeutics(DMAC) - 2024 Q2 - Quarterly Results
2024-08-07 20:32
Financial Position - DiaMedica completed a $12 million private placement, extending its cash runway into Q3 2026[1] - The company reported total cash, cash equivalents, and investments of $54.1 million as of June 30, 2024, an increase from $52.9 million at the end of 2023[9] - Cash and cash equivalents increased to $14,066,000 as of June 30, 2024, from $4,543,000 at the end of 2023, marking a significant increase of 209.5%[21] - Total assets rose to $56,791,000 as of June 30, 2024, compared to $54,160,000 at the end of 2023, reflecting a growth of 4.8%[21] - Total current liabilities increased to $3,088,000 as of June 30, 2024, compared to $2,786,000 at the end of 2023, indicating a rise of 10.9%[21] - Shareholders' equity increased to $53,415,000 as of June 30, 2024, from $51,057,000 at the end of 2023, representing a growth of 4.6%[21] Research and Development - Research and development (R&D) expenses increased to $3.9 million for Q2 2024, up from $2.5 million in Q2 2023, reflecting ongoing clinical trials[10] - A Phase 2 trial for preeclampsia is set to begin in Q4 2024, with initial proof-of-concept results expected in the first half of 2025[5] - The company has selected 15 research centers in the U.S. for the ReMEDy2 trial, with at least nine expected to be activated this quarter[2] - The company anticipates full enrollment of 144 patients for the interim analysis of the ReMEDy2 trial by Q1 2025[2] - DM199 is intended to lower blood pressure and improve perfusion to maternal organs in preeclampsia, with no approved therapeutics currently available in the U.S. or Europe[3] Income and Expenses - General and administrative (G&A) expenses decreased to $1.7 million for Q2 2024, down from $2.2 million in Q2 2023[11] - Other income increased to $526 thousand for Q2 2024, up from $271 thousand in Q2 2023, driven by higher interest income[12] - The company reported other income of $526,000 for Q2 2024, compared to $271,000 in Q2 2023, an increase of 94.1%[20] - Net cash used in operating activities for the first half of 2024 was $11.2 million, compared to $10.1 million for the same period in 2023[9] - The company generated net cash used in operating activities of $11,172,000 for the six months ended June 30, 2024, compared to $10,119,000 for the same period in 2023, an increase of 10.4%[22] - Cash flows from financing activities provided $11,751,000 in Q2 2024, compared to $36,849,000 in Q2 2023, indicating a decrease of 68.2%[22] Net Loss - The net loss for the six months ended June 30, 2024, was $10,270,000, compared to a net loss of $9,749,000 for the same period in 2023, representing an increase of 5.3%[22] - The company reported a basic and diluted net loss per share of $0.13 for Q2 2024, an improvement from $0.16 in Q2 2023[20]
DiaMedica Therapeutics(DMAC) - 2024 Q2 - Quarterly Report
2024-08-07 20:31
Clinical Trials - DM199 clinical trial (ReMEDy2) is currently enrolling approximately 350 patients globally, with an adaptive design allowing for sample size adjustments based on interim analysis results [61]. - The ReMEDy2 trial aims for a primary endpoint of physical recovery from stroke, measured by the modified Rankin Scale (mRS) at day 90 [62]. - The company plans to conduct a Phase 2 trial for DM199 in treating preeclampsia, with an estimated cost of approximately $1.5 million and initial results expected in the first half of 2025 [65]. - The Phase 2 trial for preeclampsia is expected to begin enrolling subjects in Q4 2024, with a total of up to 120 subjects planned for evaluation [65]. Financial Performance - The company reported net losses of $10.3 million for the six months ended June 30, 2024, compared to $9.7 million for the same period in 2023, with an accumulated deficit of $125.8 million as of June 30, 2024 [66]. - Net cash used in operating activities was $11.2 million for the six months ended June 30, 2024, compared to $10.1 million for the same period in 2023, reflecting an increase of approximately 10.9% [81]. - Net cash provided by financing activities was $11.7 million for the six months ended June 30, 2024, down from $36.8 million in the same period of 2023, a decrease of approximately 68.2% [83]. - 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 [84]. - The company expects to incur substantial operating losses as it continues research and development of its DM199 product candidate, with anticipated increases in losses compared to prior periods [84]. Expenses - Research and Development (R&D) expenses increased to $3.9 million for Q2 2024, up 54% from $2.5 million in Q2 2023; for the six months ended June 30, 2024, R&D expenses were $7.6 million, up 23% from $6.2 million in the same period of 2023 [74]. - General and Administrative (G&A) expenses decreased to $1.7 million for Q2 2024, down 23% from $2.2 million in Q2 2023; for the six months ended June 30, 2024, G&A expenses were $3.8 million, down 7% from $4.1 million in the same period of 2023 [75]. Cash and Funding - Cash, cash equivalents, and marketable securities totaled $54.1 million as of June 30, 2024, compared to $52.9 million as of December 31, 2023 [77]. - As of June 30, 2024, the company had working capital of $51.9 million, an increase from $50.9 million as of December 31, 2023, reflecting a growth of approximately 2% [80]. - The company received net proceeds of $11.7 million from a private placement in June 2024, but expects to need substantial additional capital for ongoing R&D activities [85]. - Future funding requirements will depend on various factors, including the timing and results of ongoing clinical trials, indicating potential volatility in cash flow needs [85]. - The company may need to seek additional funding through equity or debt financing, which could dilute existing shareholders' interests [88]. - If adequate funding is not available, the company may be forced to scale back operations or delay product development, impacting long-term growth prospects [90]. Other Income - Other income increased to $526 thousand for Q2 2024, compared to $271 thousand in Q2 2023, driven by higher interest income from increased marketable securities [76].
Are Medical Stocks Lagging DiaMedica Therapeutics (DMAC) This Year?
ZACKS· 2024-08-01 14:42
Group 1 - DiaMedica Therapeutics, Inc. (DMAC) is outperforming the Medical sector with a year-to-date return of 15.5%, compared to the sector average of 7.1% [4] - The Zacks Consensus Estimate for DMAC's full-year earnings has increased by 8.7% over the past 90 days, indicating improving analyst sentiment [4] - DMAC is ranked 2 (Buy) in the Zacks Rank system, which focuses on earnings estimates and revisions [3] Group 2 - DiaMedica Therapeutics, Inc. is part of the Medical - Biomedical and Genetics industry, which consists of 500 stocks and currently ranks 87 in the Zacks Industry Rank [6] - Stocks in the Medical - Biomedical and Genetics industry have gained approximately 1.4% year-to-date, indicating that DMAC is performing better than its peers in this specific industry [6] - Elutia Inc. (ELUT), another stock in the Medical sector, has a year-to-date return of 69% and also holds a Zacks Rank of 2 (Buy) [5]
DiaMedica: Early 2025 Interim Futility Analysis Could Be A Major Inflection Point
Seeking Alpha· 2024-07-11 18:48
DiaMedica Therapeutics (NASDAQ:DMAC) is expected to complete enrollment for an interim futility analysis of its phase 2/3 ReMEDy2 clinical trial, using DM199 for the treatment of patients with acute ischemic stroke [AIS]. Enrollment of 144 patients for such an analysis is expected by Q1 of 2025, barring that there are no delays in recruitment. Having said that, this sets up a chance for it to target a very large multibillion-dollar market, where there are no FDA approved therapies. The company is in the pro ...
DiaMedica Therapeutics(DMAC) - 2024 Q1 - Earnings Call Transcript
2024-05-11 20:49
DiaMedica Therapeutics Inc. (NASDAQ:DMAC) Q1 2024 Results Conference Call May 9, 2024 8:00 AM ET Company Participants Rick Pauls - President, CEO & Director Lorianne Masuoka - Chief Medical Officer Scott Kellen - CFO & Company Secretary Conference Call Participants Chase Knickerbocker - Craig-Hallum Thomas Flaten - Lake Street François Brisebois - Oppenheimer Operator Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics First Quarter 2024 Conference Call. An audio recording of the w ...
DiaMedica Therapeutics(DMAC) - 2024 Q1 - Quarterly Report
2024-05-08 20:34
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36291 DIAMEDICA THERAPEUTICS INC. (Exact name of registrant as specified in its charter) British Columbia (State or other juris ...
DiaMedica Therapeutics(DMAC) - 2024 Q1 - Quarterly Results
2024-05-08 20:30
Exhibit 99.1 DiaMedica Therapeutics Provides a Business Update and Announces First Quarter 2024 Financial Results Conference Call and Webcast May 9 at 8:00 AM Eastern Time / 7:00 AM Central Time Minneapolis, Minnesota – May 8, 2024 (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 quarter ended March ...
DiaMedica (DMAC) Up as Stroke Study Dosing Begins Post Relaunch
Zacks Investment Research· 2024-04-18 15:10
DiaMedica Therapeutics Inc. (DMAC) announced that it has dosed the first patient in the relaunch of its mid to late-stage stage pivotal study evaluating the safety and efficacy of its lead product candidate, DM199, to treat acute ischemic stroke (AIS). The company’s shares gained 9.7% on Apr 17, following the encouraging news.DM199 is DiaMedica’s recombinant (synthetic) form of human tissue kallikrein-1, which will be developed in the pivotal phase II/III ReMEDy2 study for AIS patients. The investigational ...
DiaMedica Therapeutics (DMAC) Loses -19.8% in 4 Weeks, Here's Why a Trend Reversal May be Around the Corner
Zacks Investment Research· 2024-04-15 14:36
DiaMedica Therapeutics, Inc. (DMAC) has been on a downward spiral lately with significant selling pressure. After declining 19.8% over the past four weeks, the stock looks well positioned for a trend reversal as it is now in oversold territory and there is strong agreement among Wall Street analysts that the company will report better earnings than they predicted earlier.How to Determine if a Stock is OversoldWe use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spott ...