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Financial Data and Key Metrics Changes - General and administrative expenses for Q2 2024 were $2.2 million, up from $1.8 million in Q2 2023, primarily due to noncash stock-based compensation and higher consulting costs [16] - Research and development expenses increased to $2.8 million in Q2 2024 from $1.5 million in Q2 2023, driven by higher headcount and clinical costs [17] - Net loss for Q2 2024 was $5 million compared to a net loss of $3.2 million in Q2 2023, with cash and cash equivalents at approximately $9.2 million at the end of the quarter [17][20] Business Line Data and Key Metrics Changes - HeartBeam is focusing on the AIMIGo system for arrhythmia detection, with plans to expand into heart attack detection, targeting a $12 billion market opportunity [7] - The company is also looking to incorporate its technology into the patch market, which is expected to grow to $4.8 billion by 2030 [8] Market Data and Key Metrics Changes - The initial focus is on symptom-driven diagnosis for arrhythmias, with future applications in heart attack detection and chronic condition monitoring [22][23] - More than 120 million Americans have some form of heart disease, indicating a significant market potential for HeartBeam's technology [8] Company Strategy and Development Direction - HeartBeam aims to disrupt multiple large markets with its AIMIGo device, which is a cable-free 12-lead ECG system [18] - The company is preparing for a limited launch of AIMIGo by the end of 2024, which will provide valuable user feedback [19] - HeartBeam is also working on a second FDA submission for algorithms that convert vector signals into synthesized 12-lead ECGs [19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of AIMIGo and its ability to transform cardiac monitoring [18] - The company is engaged in productive discussions with the FDA and believes it is progressing toward clearance for AIMIGo [21] Other Important Information - HeartBeam has completed enrollment in the VALID-ECG study, which compares AIMIGo with standard 12-lead ECGs, and results are currently being analyzed [11][25] - The company has conducted multiple clinical studies with over 500 patients, demonstrating the technology's effectiveness [14] Q&A Session Summary Question: Can you provide more detail on the timing of the FDA clearance? - Management stated that they are under active review with the FDA and are addressing additional information requests, anticipating a limited launch before the end of the year [21] Question: Can you explain the market sizes for HeartBeam's technology? - Management explained that HeartBeam's technology has a wide range of applications, starting with arrhythmia detection and moving towards chronic condition monitoring and prevention [22][23] Question: What are the results of the VALID-ECG study? - Management indicated that the data from the VALID-ECG study is currently being analyzed, and results will be the basis for a second FDA submission [25] Question: Why is AI needed if the 12-lead ECG is evaluated by a physician? - Management clarified that AI will provide automated arrhythmia classification and assist physicians in diagnosing patients based on a complete clinical picture [26][27] Question: Will the initial AIMIGo product be able to detect heart attacks? - Management confirmed that while there is still work to be done, they believe the technology will provide insights into patients with chest pain, focusing initially on arrhythmia detection [28] Question: Is the company pursuing FDA approval for atrial flutter versus atrial fibrillation? - Management stated that the initial indications for FDA clearance will cover a range of arrhythmias, including atrial flutter and atrial fibrillation [29]

Financial Performance - The company reported a net loss of $4.956 million for the three months ended June 30, 2024, compared to a net loss of $3.154 million for the same period in 2023, representing a 57% increase in loss [64]. - Operating expenses totaled $5.090 million for the three months ended June 30, 2024, a 54% increase from $3.312 million in the same period of 2023 [64]. - General and administrative ("G&A") expenses increased by approximately $0.3 million or 7% during the six months ended June 30, 2024, primarily due to non-cash stock-based compensation expense of $0.7 million [66]. - Net cash used in operating activities was $7.0 million during the six months ended June 30, 2024, primarily due to a net loss of $9.5 million [71]. - The company expects no material commercial revenue in 2024 and cannot assure that financing or strategic relationships will be available on acceptable terms [70]. - The company has incurred losses each year since inception and has experienced negative cash flows from operations in each year since inception [69]. - The company’s continued operations will depend on the ability to raise additional capital through various potential sources until sufficient revenue can be generated to achieve positive cash flow from operations [70]. Research and Development - Research and development expenses increased by 92% to $2.844 million for the three months ended June 30, 2024, compared to $1.484 million for the same period in 2023 [64]. - Research and development ("R&D") expenses increased by approximately $1.4 million or 92% during the three months ended June 30, 2024, compared to the same period in 2023 [67]. - R&D expenses increased by approximately $2.1 million or 67% during the six months ended June 30, 2024, compared to the same period in 2023 [68]. - The company completed patient enrollment in the VALID-ECG study with a total of 198 patients, aimed at validating the AIMIGo 12L ECG Synthesis Software [52]. - The company has acquired approximately one million 12L ECGs to support its AI development efforts [54]. Regulatory and Product Development - The company has filed a 510(k) submission with the FDA for the HeartBeam AIMIGo device and is in the substantive review phase [50]. - The company plans to launch the AIMIGo 3L system by the end of 2024, which will provide valuable user feedback [53]. - The company has been granted two new U.S. patents in 2024, bringing the total to 13 issued U.S. patents [58]. Financing and Capital - The company entered into a PV Sales Agreement to offer up to $17 million of its common stock, with approximately $16.9 million available for issuance as of June 30, 2024 [60]. Awards and Recognition - The company was awarded the "Best New ECG Technology Solution" at the 8th annual MedTech Breakthrough Awards [62].

Core Insights - Revumenib shows promising efficacy in combination with standard therapies for acute myeloid leukemia (AML), with a 96% composite complete remission (CRc) rate in the BEAT AML trial [7][5][6] - The company is advancing revumenib across various acute leukemia patient settings, with plans for a pivotal trial by the end of 2024 [9][6] Company Overview - Syndax Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing innovative cancer therapies, including revumenib, a selective menin inhibitor [3][5] - The company is also developing axatilimab, a monoclonal antibody targeting the CSF-1 receptor [3] Clinical Trial Data - In the BEAT AML trial, 26 newly diagnosed AML patients were enrolled, achieving a 96% CRc rate and 92% minimal residual disease (MRD) negative status [7][8] - The AUGMENT-102 trial reported a 52% CRc rate in patients with relapsed/refractory AML, with a significant portion achieving MRD negative status [5][11] - Revumenib was well-tolerated, with manageable adverse events, and showed no new safety signals when combined with other therapies [8][12] Future Directions - An expansion cohort is ongoing to establish the recommended dose for future trials, with a pivotal trial planned for newly diagnosed patients by year-end 2024 [9][6] - Revumenib has received Orphan Drug Designation and Breakthrough Therapy Designation from the FDA for treating specific AML patient populations [15]

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HeartBeam, Inc. (NASDAQ:BEAT) Q1 2024 Earnings Conference Call May 9, 2024 4:30 PM ET Company Participants Branislav Vajdic - Founder and CEO Rob Eno - President Rick Brounstein - Consulting Chief Financial Officer Brooks Hamilton - Investor Relations, MZ Group Conference Call Participants Leo Carpio - Joseph Gunnar Operator Greetings. And welcome to the HeartBeam First Quarter 2024 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session wil ...

HEARTBEAM, Inc. See accompanying notes to the condensed unaudited financial statements In February 2023, the Company entered into a sales agreement (the "Sales Agreement") with A.G.P./Alliance Global Partners ("AGP") pursuant to which the Company may issue and sell, from time to time, shares of the Company's common stock having an aggregate offering price of up to $13.0 million in at-the-market offerings ("ATM") sales, which was terminated in May 2024. NET LOSS PER COMMON SHARE In March 2024, the FASB issue ...

HeartBeam (NASDAQ:BEAT) just reported results for the fourth quarter of 2023.HeartBeam reported earnings per share of -13 cents. This met the analyst estimate for EPS of -13 cents.The company did not report any revenue for the quarter.InvestorPlace Earnings is a project that leverages data from TradeSmith to automate coverage of quarterly earnings reports. InvestorPlace Earnings distills key takeaways including earnings per share and revenue, as well as how a company stacks up to analyst estimates. These ar ...

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Start Time: 16:30 January 1, 0000 5:11 PM ET HeartBeam, Inc. (NASDAQ:BEAT) Q4 2023 Earnings Conference Call March 20, 2024, 16:30 PM ET Company Participants Branislav Vajdic - CEO and Founder Rob Eno - President Deborah Castillo - VP of Regulatory Affairs Rick Brounstein - Consulting CFO Conference Call Participants Ben Haynor - Alliance Global Partners Operator Greetings, and welcome to the HeartBeam Fourth Quarter and Full Year 2023 Financial Results Conference Call. At this time, all participants are in ...