Financial Data and Key Metrics Changes - Net cash used in operating activities was $14.5 million for FY 2024, representing a 20% increase year-over-year, primarily due to investments in R&D and achieving FDA clearance [37][38][40] - G&A expenses remained largely flat, with less than a 4% increase year-over-year, indicating financial discipline [39] Business Line Data and Key Metrics Changes - The company received FDA clearance for the HeartBeam system in December, marking a significant milestone [9][16] - A second 510(k) application for the twelve-lead synthesis software was submitted in January, currently under FDA review [10][17] Market Data and Key Metrics Changes - The initial target market includes concierge medicine patients, estimated at 1.5 million in the US, with a potential revenue opportunity of $250 to $500 million annually [29][30] - The broader direct patient pay market could represent a revenue opportunity of $1.3 to $2.6 billion annually, focusing on patients aged 35 to 74 with elevated cardiac risk [31] Company Strategy and Development Direction - The company aims to establish itself as the first personal cable-free synthesized twelve-lead ECG, starting with direct patient pay and expanding to payer plans and integrated healthcare systems [22][24] - The go-to-market strategy includes a pilot commercialization phase in two geographic markets, focusing on customer experience and retention [26][51] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about achieving key milestones in 2025, including FDA clearance for the twelve-lead synthesis software [48][50] - The company is focused on minimizing cash burn while preparing for commercialization, with a strong belief in the value of its technology [45][46] Other Important Information - The company completed a public offering of $11.5 million, which will support upcoming milestones and operational readiness [14][36] - HeartBeam, Inc. received the Diamond Pinnacle Health Care Award for medical device innovation, highlighting its contributions to patient care [15] Q&A Session Summary Question: What went into your decision to not immediately commercialize upon clearance? - The company decided to wait for the twelve-lead synthesis software clearance to ensure differentiation in the market [55] Question: What are your expectations for cash burn in 2025 and timing of next raise? - The expected cash burn for 2025 is similar to the $14.5 million spent in 2024, with a focus on prudent spending in the first half of the year [57][60] Question: Can you discuss the pathway or roadmap to get to heart attack detection? - The company plans to engage with the FDA soon and initiate a clinical study for heart attack detection later this year [64][68] Question: Is there any competition in the same space? - The company does not see direct competitors for its small cable-free ECG device that synthesizes a twelve-lead ECG, emphasizing its unique IP [69][72] Question: Are you concerned about political changes affecting timely FDA approval? - Management has not seen an impact on the FDA submission process and remains confident in their interactions with the review team [74][76] Question: Does your initial go-to-market plan include wearables? - The device is not a wearable, but there is potential for integration with wearable data [77][79] Question: Are you planning to initially commercialize this technology alone or with a partner? - The initial pilot commercialization will be conducted by the company's own team, with options for partnerships evaluated later [80][82] Question: When is the expected clearance time from FDA for the second clearance? - The company estimates receiving FDA clearance for the twelve-lead synthesis software before the end of the year [84][86] Question: Can you give us more details on the early access program? - The early access program aims to evaluate the offering and prepare for commercialization, involving hundreds of patients [87][89]

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 ...