Financial Performance - The company reported a net loss of $19.448 million for the year ended December 31, 2024, compared to a net loss of $14.639 million in 2023, representing a 33% increase in losses [255]. - The company reported a net loss of $19.5 million for the year ended December 31, 2024 [264]. - Net cash used in operating activities for the year ended December 31, 2024, was $14.5 million, compared to $12.1 million for the year ended December 31, 2023 [264][265]. - Net cash provided by financing activities decreased significantly from $24.9 million in 2023 to $0.9 million in 2024 [267]. - The company expects existing cash to be insufficient to fund operations for the next twelve months, raising substantial doubt about its ability to continue as a going concern [261]. Research and Development - Research and development expenses increased by 63% to $11.051 million in 2024, up from $6.798 million in 2023 [255]. - Research and development (R&D) expenses increased by $4.3 million or 63% compared to the same period in 2023, primarily due to increased headcount and clinical-related costs [257]. - The VALID-ECG pivotal study enrolled 198 patients across five clinical sites to validate the HeartBeam 12 Lead ECG Synthesis Software for arrhythmia detection [236]. - The company has acquired approximately one million 12L ECGs to support its AI development efforts [238]. Leadership Changes - The company appointed Timothy Cruickshank as CFO and Robert Eno as CEO in 2024, indicating a strategic leadership transition [250][252]. Patents and Intellectual Property - As of December 31, 2024, the company had 14 issued U.S. patents and 9 pending applications, with patents expected to expire between April 11, 2036, and April 21, 2042 [241]. Capital and Financing - The company entered into a PV Sales Agreement to offer up to $17 million of common stock, with approximately $16.2 million available for issuance as of December 31, 2024 [247]. - The company raised $0.7 million from the sale of common stock and $0.1 million from stock options during the year ended December 31, 2024 [260]. - Subsequent to year-end, the company raised $11.5 million through a public offering [260]. Operating Expenses - Total operating expenses rose by 30% to $19.887 million in 2024, compared to $15.314 million in 2023 [255]. - Net cash used in investing activities was $0.2 million in 2024, consistent with $0.3 million in 2023, primarily for property and equipment purchases [266]. Product Development - The HeartBeam System received FDA clearance on December 13, 2024, marking it as the first FDA cleared cable-free, ambulatory ECG device [231]. - The company plans to initiate an Early Access Program for the HeartBeam System to gather user feedback before commercialization [237]. Cash Position - As of December 31, 2024, the company had approximately $2.4 million in cash and cash equivalents, a decrease of $13.8 million from $16.2 million as of December 31, 2023 [259]. - The company does not have any off-balance sheet arrangements [268].

Financial Data and Key Metrics Changes - The net loss for Q3 2024 was approximately $4.979 million, with adjusted net cash used in operating activities at $3.3 million, primarily focused on R&D and clinical initiatives [27] - The cash balance as of September 30, 2024, was $5.8 million [27] Business Line Data and Key Metrics Changes - HeartBeam has developed a cable-free 12-lead ECG technology that captures high-resolution cardiac data, positioning itself to disrupt the cardiac care market valued at over $100 billion annually in the U.S. [6][7] - The company has a growing body of clinical evidence, with nine peer-reviewed publications and over 500 patients enrolled in studies demonstrating the technology's potential [21] Market Data and Key Metrics Changes - HeartBeam's technology is applicable in multiple large markets, with a strategy that includes symptom-driven diagnosis, monitoring, and ultimately replacing traditional ECGs [7] - The company received recognition as a "Rising Star" at the Global Healthcare Conference and a MedTech Breakthrough Award for best new ECG technology solution [24] Company Strategy and Development Direction - The company is focused on achieving FDA clearance as a foundational milestone, which will enable future product submissions and commercialization efforts [31][36] - HeartBeam's initial go-to-market strategy targets direct patient pay in concierge and preventive cardiology practices, with plans to gather evidence for insurance reimbursement [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving FDA clearance and emphasized the importance of the upcoming early access program for user feedback [40][41] - The company is preparing for commercialization and aims to minimize cash burn while delivering on key milestones [38] Other Important Information - The management team has evolved to better position the company for commercialization, with new appointments including a Chief AI Officer [37] - HeartBeam is engaged in productive discussions with the FDA and remains optimistic about achieving foundational clearance [36] Q&A Session Summary Question: Can you provide more detail on the timing of the FDA clearance? What are the outstanding items? - Management reiterated that the FDA is engaged and responsive, expressing confidence in achieving clearance in the near term [40] Question: Given your cash burn, what are your plans for raising capital? - The company is managing cash burn closely and has strong support from existing shareholders, focusing on maintaining and adding value-add investors [42][43] Question: Can you provide more context on the timing and reason for the change in CEO from Branislav to Rob? - The transition was planned, with Branislav focusing on technical efforts while Rob leads commercialization due to his commercial background [44][46][47] Question: Can you provide an update on the VALID-ECG study? - Enrollment for the 198-patient VALID-ECG study has been completed, and data will be the basis for the upcoming FDA submission [48][49] Question: If everything goes right with the FDA, what could 2025 revenues look like for HeartBeam? - The company does not anticipate significant revenue in 2025 but aims to refine its go-to-market strategy and gather critical user feedback [50][52]

Product Development and Technology - The HeartBeam System, a credit card-sized ECG device, is in the substantive review phase with the FDA, aiming for clearance as the first patient-held VECG device [61]. - A total of 198 patients were enrolled in the VALID-ECG Study to demonstrate the equivalence of the HeartBeam Synthesized 12L ECG to a standard 12L ECG [63]. - The company has developed initial deep learning algorithms for detecting cardiac arrhythmias, with data presented at two major electrophysiology conferences in 2024 [67]. - The HeartBeam technology demonstrated the ability to detect coronary artery occlusion with accuracy comparable to standard 12L ECGs, improving diagnostic performance metrics significantly [69][70]. - The company anticipates that the Early Access Program for the HeartBeam System will provide valuable user feedback in the coming months [65]. Financial Performance - General and administrative (G&A) expenses increased by approximately $0.06 million or 3% for the three months ended September 30, 2024, compared to the same period in 2023, primarily due to increased headcount and higher consultant costs [85]. - Research and development (R&D) expenses increased by approximately $1.3 million or 78% for the three months ended September 30, 2024, driven by increased headcount, clinical and AI-related costs, and consulting spend [87]. - Total operating expenses for the three months ended September 30, 2024, were $5.069 million, a 36% increase from $3.737 million in the same period of 2023 [85]. - Net loss for the three months ended September 30, 2024, was $4.979 million, representing a 43% increase from a net loss of $3.470 million in the same period of 2023 [85]. - Cash and cash equivalents as of September 30, 2024, were approximately $5.8 million, a decrease of $10.4 million from $16.2 million as of December 31, 2023 [94]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $10.319 million, compared to $9.235 million for the same period in 2023 [94]. - R&D expenses for the nine months ended September 30, 2024, increased by approximately $3.4 million or 71% compared to the same period in 2023, primarily due to increased clinical and AI-related costs [88]. - The company expects no material commercial revenue in 2024 and faces substantial doubt regarding its ability to continue as a going concern without raising additional capital [93]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $0.105 million, a significant decrease from $24.994 million in the same period of 2023 [98]. - The company has incurred losses each year since inception and has experienced negative cash flows from operations in each year since inception [92]. Management Changes - Timothy Cruickshank was appointed as CFO on September 10, 2024, succeeding Richard Brounstein [81]. - Robert Eno was appointed as CEO on October 17, 2024, succeeding founder Branislav Vajdic, who will focus on R&D and AI applications [83]. Intellectual Property - The company has been granted two new U.S. patents in 2024, bringing the total to 17 issued patents worldwide [75]. Workforce and Growth - As of September 30, 2024, the company had 20 employees and plans to hire additional professionals to support growth strategies [72].

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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 ...