HeartBeam, Inc.
For the period ended Mar 31, 2025. Filed May 13, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 13, 2025
BEAT$0.40+1.8%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-07.
0001628280-24-046250
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-13.
0001628280-25-025064
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 68 previous paragraphs and 54 current paragraphs.
15 unchanged; 22 reworded; 17 added; 30 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 3 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (17)
Current report
The HeartBeam System (previously referred to as “AIMIGo TM”) was granted FDA clearance on December 13, 2024. The HeartBeam System is the first U.S. Food and Drug Administration (“FDA”) cleared cable-free, ambulatory 3-D ECG that captures the heart’s electrical signals from three distinct directions for high-fidelity data collection and advanced diagnostics for arrhythmia assessment. The HeartBeam System is comprised of a credit card sized 3-Lead ECG recording device, a patient application, a physician portal, and powerful cloud-based algorithms.
Current report
In January 2025, the Company filed a 510(k) application for the software algorithms that synthesize a 12L ECG from the 3-Lead ECG recorded signal obtained by the HeartBeam System. The software synthesizes these signals into a familiar 12L ECG display, using a personalized transformation matrix. This latest submission builds on HeartBeam’s recent FDA clearance, and once cleared by the FDA, the cumulative result will be an ambulatory device, carried by patients, which can synthesize a 12L ECG for manual assessment of arrhythmia by physicians.
Current report
In April 2025, the Company announced that the VALID-ECG pivotal study successfully met its clinical endpoints. The study evaluated the mean difference in ECG intervals and amplitudes between HeartBeam’s synthesized 12L ECG and a simultaneously collected standard 12L ECG. Intervals and amplitudes are important in assessing non-life-threatening arrhythmias. Data showed a 93.4% overall diagnostic agreement, indicating that HeartBeam’s synthesized 12-lead ECG can support diagnosis of arrhythmias in a manner consistent with standard 12L ECGs.
Current report
During the first quarter of 2025 and ensuing period, the Company continued its efforts with commercial readiness activities, in advance of an anticipated commercial launch that will occur once we receive FDA clearance for our 12L synthesis software.
Current report
In April 2025, HeartBeam announced a strategic collaboration with AccurKardia to potentially add their FDA-cleared, automated ECG interpretation platform to our Product. Adding AccurKardia’s FDA-cleared, device-agnostic automated ECG interpretation platform to HeartBeam’s device will enhance HeartBeam’s commercial offering for arrhythmia assessment by enabling patients and physicians to get an automated rhythm assessment which will facilitate a quicker diagnosis and faster access to clinical care when needed. The strategic collaboration is expected to expedite HeartBeam’s product development efforts, reducing both costs and timelines.
Current report
HeartBeam has 15 issued and allowed U.S. patents (U.S. 10,433,744, U.S. 10,117,592, U.S. 11,071,490, U.S. 11,419,538, U.S. 11,445,963, U.S. 11,701,049, U.S. 11,529,085, U.S. 10,980,433, U.S. 11,412,972, U.S. 11,234,658, U.S. 11,793,444, U.S. 11,877,853, U.S. 11,969,251, U.S. US 12,207,908 and U.S. 12,290,368) Outside of the U.S., HeartBeam has five issued patents in South Korea, Germany, France, Netherlands and the United Kingdom
Current report
•The first patent significantly advances intellectual property for HeartBeam’s credit card-sized ECG device, bolstering both the defensive and offensive moat around the company’s core technology.
Current report
•The second patent expands the use of risk-based diagnostic algorithms into HeartBeam’s product portfolio around wearable devices.
Current report
February Public Offering under Form S-3
Current report
During the three months ended March 31, 2025, we entered into an underwriting agreement with Public Ventures, LLC dba MDB Capital (“Public Ventures”) to consummate an offering (the “February Public Offering”) and we have raised approximately $11.5 million in gross proceeds through sales of common stock as listed below:
Current report
•On February 12, 2025, 5,882,353 shares of common stock sold at an offering price of $1.70 per share, which closed on February 14, 2025. The Company received $8.94 million in net proceeds from the February Public Offering after deducting underwriter discounts and commissions. In addition, pursuant to the underwriting agreement, as partial compensation for its service, we granted 588,235 underwriter warrants with an exercise price of $2.13 to Public Ventures.
Current report
•On February 21, 2025, Public Ventures exercised the bulk of their over-allotment option (the “Over-allotment Option”) of 864,033 shares of common stock which closed on February 25, 2025. The Company received $1.31 million in net proceeds from the Over-allotment Option after deducting underwriter discounts and commission and we granted an additional 86,403 underwriter warrants with an exercise price of $2.13 as compensation to Public Ventures.
Current report
Strategic Collaboration with AccurKardia
Current report
On April 24, 2025, HeartBeam announced a strategic collaboration with AccurKardia to advance cardiac monitoring innovation. Adding AccurKardia’s FDA-cleared, device-agnostic automated ECG interpretation platform to HeartBeam’s device will enhance HeartBeam’s commercial offering for arrhythmia assessment by enabling patients and physicians to get an automated rhythm assessment which will facilitate a quicker diagnosis and faster access to clinical care when needed. The strategic collaboration is expected to expedite HeartBeam’s product development efforts, reducing both costs and timelines.
Current report
As of March 31, 2025, we had approximately $4.4 million in cash and cash equivalents, an increase of $2.0 million from $2.4 million as of December 31, 2024.In addition, the Company held, short-term investments of $3.8 million as treasury securities at the balance sheet date. When combined with cash and cash equivalents of $4.4 million, the balance for the Company as at March 31, 2025 was $8.2 million.
Current report
As of March 31, 2025, the Company held two treasury securities with maturity dates of greater than 90 days. These short-term investments have an amortized cost basis of approximately $3.8 million and maturity periods of 94 and 119 days, respectively. When combined with cash and cash equivalents of $4.4 million, the balance for the Company at March 31, 2025 was $8.2 million
Current report
We had no financing activity during the three months ended March 31, 2024.
Removed paragraphs (30)
Previous report
Our Products (“Product” or “Products”) require FDA clearance and have not been cleared for marketing.
Previous report
To date, we have developed a working prototype for the HeartBeam System and have filed a 510(k) submission with the FDA. This submission is for the initial Product, a device which is a 3 lead (3L) X, Y, Z vector VECG. We are in the substantive review phase of answering questions posed by the FDA on this submission. We have clarified the information requested in meetings with FDA representatives and are finalizing our official responses. During the second half of 2024 we received additional questions from FDA, have provided answers and additional data, and are engaged in productive discussions to finalize the clearance. If cleared as anticipated, we believe this will be the first patient-held VECG device to be cleared by the FDA and this will be a major milestone for the company.
Previous report
We are currently analyzing the data and working on the other components of the second 510(k) application. We anticipate submitting this 510(k) application soon after receiving the initial FDA clearance. The result of these two 510(k) submissions, if cleared by the FDA as anticipated, will be an ambulatory device, carried by patients, which can synthesize a 12L ECG for physician review.
Previous report
We have developed initial deep learning algorithms, focused on the ability to detect various cardiac arrhythmias. HeartBeam has had data on its deep learning algorithm presented at two prestigious Electrophysiology conferences. Data were presented at the European Heart Rhythm Association in Berlin, Germany in April 2024 and at the Heart Rhythm Society, in Boston, MA in May 2024. We believe that, when combined with our Products, HeartBeam’s AI will provide additional value to patients and physicians in several ways, including:
Previous report
•Providing automated classification of cardiac conditions, including common arrhythmias,
Previous report
•Potentially enhancing user experience and simplify the onboarding process, and
Previous report
•In the longer run, we believe that applying deep learning algorithms on top of the rich VECG data, especially with the longitudinal dataset from patients taking repeated readings, may result in unsurpassed predictive and diagnostic capabilities.
Previous report
A landmark clinical study on the HeartBeam technology was published in the August 2023 issue of the journal JACC: Advances. The publication, “Coronary Artery Occlusion Detection Using 3-Lead ECG System Suitable for Credit Card-Size Personal Device Integration” demonstrated that HeartBeam’s VECG technology detects the presence of a coronary occlusion, the cause of heart attacks, with the same accuracy as a standard 12L ECG.
Previous report
The study showed that the automated analysis of the VECG and 12L ECG signals had similar performance in determining whether a coronary artery was occluded. Also in the study, the human interpretation of the 12L ECGs had significant intra- and inter-observer variability, which does not occur with automated readings. The study also showed that the presence of the “normal baseline” recording, a novel feature that is integral to HeartBeam’s VECG technology, dramatically improved the accuracy of interpretation, increasing the Area Under the Curve, a standard measure of diagnostic performance, from 0.72 to 0.95. This is particularly important since physicians who are analyzing 12L ECGs often do not have access to a normal baseline, implying that the HeartBeam system could outperform this approach.
Previous report
The study was a collaboration of Harvard Medical School Faculty at Beth Israel Deaconess Medical Center in Boston, MA, and Clinical Center of Serbia in Belgrade.
Previous report
•One patent covers apparatuses and methods that facilitate the comparison of cardiac signals over time for the automated or assisted detection of heart attacks. The other patent covers methods and apparatuses around HeartBeam’s wrist-based ECG system.
Previous report
Interactions with Industrial Players
Previous report
We believe that our VECG technology has the potential to be the most advanced ambulatory cardiac monitoring solution and is applicable in a number of form factors. In anticipation of FDA clearance, we are refining our go-to-market strategy and are encouraged by our early discussions with industry players and their interest in our technology.
Previous report
Presentations at AHA
Previous report
In August 2024, we were notified of the acceptance of two of our pilot studies for presentation at American Heart Association meeting in November 2024. The studies are designed to show early evidence of (1) clinical equivalence of the HeartBeam Synthesized 12L ECG to a standard 12L ECG for diagnosis of arrhythmia and (2) the use of the technology for heart attack detection.
Previous report
At-the-Market Offering
Previous report
On May 2, 2024, we entered into the PV Sales Agreement with Public Ventures, pursuant to which we may offer and sell from time to time, at our option, through or to Public Ventures, up to an aggregate of approximately $17 million of shares of the Company’s common stock, $0.0001 par value per share (the “Shares”). We will pay Public Ventures a commission at a fixed rate of 3.0% of the aggregate gross proceeds from each sale of the Shares under the PV Sales Agreement. There were 50,000 Shares issued under the ATM during the three months ended June 30, 2024. As of September 30, 2024, there was approximately $16.9 million available for issuance under the ATM following the use of the shelf registration on Form S-3 for the Agreements and the ATM during the quarter.
Previous report
Any Shares to be offered and sold under the PV Sales Agreement will be issued and sold pursuant to our Registration Statement on Form S-3 (File No. 333-269520), filed with the Securities and Exchange Commission on February 1, 2023 and the prospectus supplement included therein, relating to the Offering, by methods deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, or if specified by us, by any other method permitted by law.
Previous report
In order to proceed with the PV Sales Agreement, we terminated the prior Sales Agreement with A.G.P/Alliance Global Partners.
Previous report
Appointment of Additional Senior Management Team members
Previous report
On September 10, 2024, we announced the appointment of Timothy Cruickshank as Chief Financial Officer (CFO). Mr. Cruickshank brings more than 15 years of public company experience with a focus on growing businesses with disruptive technologies through authentic leadership, strategic focus, data-driven decisions, and strong risk management and governance. He succeeds long-time CFO Richard Brounstein, who has been serving in an advisory capacity since retiring in February 2024.
Previous report
On September 24, 2024, we announced the appointment of Lance Myers, PhD, a pioneer in digital health data analytics and body-worn biosensor technologies, as Chief Artificial Intelligence (AI) Scientist. In this newly created position, Dr. Myers will play a pivotal role in guiding how AI is applied to the Company’s core technology. Most recently, Dr. Myers served as AI Advisor to HeartBeam until September 23, 2024.
Previous report
On October 17, 2024, we announced the appointment of Robert Eno as Chief Executive Officer (CEO). Mr. Eno joined HeartBeam as President in January 2023 and will lead as the Company continues to work towards securing the foundational FDA 510(k) clearance for its vector-based technology and prepares for commercialization and growth. As part of a long-planned transition, Mr. Eno succeeds long-time CEO and founder, Branislav Vajdic, Ph.D. Dr. Vajdic will continue as President of HeartBeam, focused on innovating on the Company’s groundbreaking vector-based technology, driving research and development efforts, and advancing artificial intelligence (AI) applications.
Previous report
General and administrative (“G&A”) expenses increased by approximately $0.4 million or 6% during the nine months ended September 30, 2024. The increase in G&A expense is primarily related to non-cash stock-based compensation expense amounting to $0.7 million associated with additional awards granted since September 30, 2023, higher consulting costs of $0.4 million related to finance consultants, primarily offset by decrease in payroll cost of $0.4 million related to lower costs associated with restructuring of G&A headcount, decrease of $0.5 million comprising of lower investor relation costs, and legal costs incurred in this period compared to the prior period.
Previous report
Research and development expenses (“R&D”) expenses increased by approximately $3.4 million or 71% during the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023. The increase in R&D expense is primarily related to increase in headcount of $0.9 million and non-cash stock-based compensation expense amounting to $0.5 million associated with additional awards granted since September 30, 2023, increase of clinical and AI related costs of $2.0 million, increase in consulting spend of $1.0 million offset by decrease in product development consulting cost of $0.8 million primarily driven by completion of milestone projects in prior period.
Previous report
As of September 30, 2024, we had approximately $5.8 million in cash, a decrease of $10.4 million from $16.2 million as of December 31, 2023.
Previous report
Stock-based Compensation
Previous report
The compensation cost for all stock-based awards is measured at the grant date, based on the fair value of the award, determined using a Black-Scholes option pricing model for stock options and fair value on the date of grant for non-vested restricted stock, and is recognized as an expense over the employee’s requisite service period (generally the vesting period of the equity award). Determining the fair value of stock-based awards at the grant date requires significant estimates and judgments. Management has determined the fair value and vesting period of stock-based compensation to be a critical accounting estimate due to certain options containing performance-based vesting condition.
Previous report
Research and Development: Clinical and Manufacturing Accruals
Previous report
We record accruals for estimated costs of research, preclinical studies and clinical trials, and manufacturing development, which are a significant component of research and development expenses. A substantial portion of our ongoing research and development activities are conducted by one CRO. Our contract with this CRO include pass-through fees such as regulatory expenses, investigator fees, travel costs and other miscellaneous costs. We accrue the costs incurred under agreements with CRO based on estimates of actual work completed in accordance with the CRO agreement. We determine the estimated costs based on actual services performed by the CRO and clinical sites as at each period end. As actual costs become known, we adjust our accruals. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and could result in our reporting amounts that are too high or too low in any particular period.
Reworded paragraphs (22)
Previous wording
We are a medical technology company focused on transforming cardiac care through the power of personalized insights. Our aim is to deliver innovative, higher resolution ambulatory cardiac monitoring solutions that can be used by patients anywhere to enable the detection and monitoring of cardiac disease outside of a healthcare facility. Our ability to develop higher resolution Electrocardiogram (“ECG”) solutions is achieved through the development of our proprietary and patented Vector Electrocardiography (“VECG”) technology platform. Our VECG technology is capable of capturing 3D vector signals of the heart’s electrical activity and synthesizing a 12-Lead (“12L”) ECG from these signals. In early studies, our approach demonstrated equal or superior diagnostic capability than traditional hospital-based 12L ECG systems.
Current wording
We are a medical technology company focused on transforming cardiac care through the power of personalized insights. Our aim is to deliver innovative, higher resolution ambulatory cardiac monitoring solutions that can be used by patients anywhere to enable the detection and monitoring of cardiac disease outside of a healthcare facility. Our ability to develop higher resolution Electrocardiogram (“ECG”) solutions is achieved through the development of our proprietary and patented technology platform that allows us to collect the heart’s electrical activity from three distinct directions and synthesize a 12-Lead (“12L”) ECG from these signals. In recent studies, our approach has demonstrated diagnostic insights similar to a standard 12L ECG for arrhythmia assessment. The data from these studies was also submitted to the FDA as part of our recent FDA submission.
Previous wording
We believe our Products and services will benefit many stakeholders, including patients, healthcare providers, and healthcare payors. We are developing our telehealth Product, (“the HeartBeam System”, previously referred to as “AIMIGo™”), to address the rapidly growing field of ambulatory cardiac health monitoring. The HeartBeam System is comprised of a credit card sized electrocardiogram device, a patient application, a physician portal, and powerful cloud-based algorithms. We believe that we are uniquely positioned to play a central role in ambulatory cardiac monitoring including high-risk Coronary Artery Disease (“CAD”) patients, because the initial studies have shown that our ischemia detection system may be more accurate than existing ambulatory monitoring solutions. CAD patients are at increased risk for a heart attack or Myocardial Infarction (“MI”).
Current wording
We believe our Products (“Products” or “Product”) and services will benefit many stakeholders, including patients, healthcare providers, and healthcare payors, and will also address the rapidly growing field of ambulatory cardiac health monitoring. We believe that we are uniquely positioned to play a central role in ambulatory cardiac monitoring including high-risk Coronary Artery Disease (“CAD”), given positive, proof-of-concept data from the initial feasibility studies that demonstrated comparable performance of the HeartBeam System and the standard 12L ECG in ischemia detection. CAD patients are at increased risk for a heart attack or Myocardial Infarction (“MI”). Additionally, our unique portable form-factor will make high-fidelity insights easily accessible, wherever patients are, compared to a standard 12L ECG which is typically limited to a healthcare setting.
Previous wording
Following FDA clearance of the HeartBeam System, we plan to file a submission for the software algorithms that synthesize a 12L ECG from the HeartBeam System. We have held two pre-submission meetings with the FDA on this 12L synthesis submission. These meetings focused primarily on the performance goals of our clinical study that is designed to demonstrate the similarity between our synthesized 12L signal and the output of a standard 12L ECG for the intended use. Based on feedback from FDA and our clinical experts, we have designed a prospective multicenter pivotal study, the VALID-ECG Study for clinical validation of the HeartBeam 12 Lead ECG Synthesis Software for Arrhythmia Detection.
Current wording
The Company held two pre-submission meetings with the FDA ahead of the 12L ECG synthesis software submission. These meetings focused primarily on the performance goals of our clinical study designed to demonstrate the similarity between our synthesized 12L ECG signal and the output of a standard 12L ECG for the arrhythmia assessment.. Based on feedback from FDA and our clinical experts, the Company designed a prospective multicenter pivotal study, the VALID-ECG pivotal study, for clinical validation of the HeartBeam 12L ECG synthesis software for arrhythmia assessment.
Previous wording
On June 20, 2024, we completed patient enrollment in the VALID-ECG Study. A total of 198 patients were enrolled from five clinical sites in the United States. The primary objective was to demonstrate the equivalence of ECG waveforms between the HeartBeam System Synthesized 12L ECG and Standard 12L ECG, recorded simultaneously in each subject, by assessing relevant ECG characteristics, i.e. intervals and amplitudes. Efforts were made to enroll patients with a diverse demographic profile reflective of the intended use population in the United States.
Current wording
The VALID-ECG pivotal study was a multicenter trial that enrolled 198 patients across five clinical sites in the US, including Allegheny Health Network, Atlanta Heart Specialists, Mount Sinai Hospital, Northwell Health and Piedmont Heart Institute. Efforts were made to enroll patients with a diverse demographic profile reflective of the intended use population in the United States.
Previous wording
We continue to anticipate that our Early Access Program for the HeartBeam System will occur in coming months. This program will provide the company with valuable feedback on the user experience and functionality of the system in a real world setting. We do not anticipate that the HeartBeam System clearance will generate significant revenue before the 12L clearance.
Current wording
The Company initiated an early access program (the “Early Access Program”) for the HeartBeam System. This program will provide the Company with valuable feedback on the user experience, overall workflow and functionality of the system in a real-world setting. We do not anticipate that the Early Access Program will generate revenue. The intent of the Early Access Program is to prepare the Company to commercialize the technology once we receive FDA clearance for our 12L synthesis software.
Previous wording
We also have an active AI program underway. Our AI team includes 5 PhDs. The leadership has deep AI expertise, including prior positions at Apple, Microsoft and Google. We have acquired approximately one million 12L ECGs from various sources, a key element in our fast-paced AI development efforts.
Current wording
In addition, the Company also has an active AI program underway. We have acquired approximately one million standard 12L ECGs from various sources, a key element in our fast-paced AI development efforts. We believe that, when combined with our Products, these deep learning algorithms will provide additional value to patients and physicians in several ways.
Previous wording
The custom software and hardware of our Products are classified as Class II medical devices by the FDA, running on an FDA registered Class I software platform. Premarket review and clearance by the FDA for Class II devices is generally accomplished through the 510(k) premarket notification process or De Novo process. Given the proposed intended use of our device, the 510(k) submission is expected to require clinical data to support FDA clearance.
Current wording
The custom software and hardware of our Products are classified as Class II medical devices by the FDA. Premarket review and clearance by the FDA for Class II devices is generally accomplished through the 510(k) premarket notification process or De Novo process. Given the proposed intended use of our device, the 510(k) submission or De Novo process is expected to require clinical data to support FDA clearance.
Previous wording
As of September 30, 2024, we had 20 employees. We intend to hire or engage additional full-time professionals, employees, and / or consultants to align with our growth strategy. Although the market is highly competitive for attracting and retaining highly qualified professionals in our industry, we continue our endeavor to find such candidates for our Company. Our management team and additional personnel that we may hire in the future will be primarily responsible for executing and implementing growth opportunities, making tactical decisions related to our strategy and pursuing opportunities to invest in new technologies through strategic partnerships and acquisitions.
Current wording
As of March 31, 2025, we had 19 employees. We intend to strike a balance of managing our headcount in line with cash resources, while also, at the appropriate time, hiring or engaging additional full-time professionals, employees, and / or consultants in alignment with our growth strategy. Although the market is highly competitive for attracting and retaining highly qualified professionals in our industry, we continue our endeavor to find such candidates for our Company. Our management team and additional personnel that we may hire in the future will be primarily responsible for executing and implementing growth opportunities, making tactical decisions related to our strategy and pursuing opportunities to invest in new technologies through strategic partnerships and acquisitions.
Previous wording
Thus far in 2024, we have been granted two new U.S. patents:
Current wording
Thus far in 2025, we have been granted two new U.S. patents related to HeartBeam’s compact, mobile three-lead cardiac monitoring devices and detection of atrial fibrillation.
Previous wording
•We now have 17 issued patents worldwide, with 13 issued patents in the U.S. and four issued patents in Germany, France, Netherlands and United Kingdom. Additionally, we have ten pending U.S applications and twenty-one pending applications in Canada, China, the European Union, Japan, South Korea and Australia. We also have one pending Patent Cooperation Treaty application. The issued patents are predicted to expire between April 11, 2036 and March 4, 2044.
Current wording
The Company now has 20 issued patents worldwide, including fifteen (15) issued U.S. patents and eleven (11) pending U.S applications. Outside of the U.S., we have five (5) issued patents in South Korea, Germany, France, Netherlands and United Kingdom, two (2) allowed patents and twenty-one (21) pending applications in Canada, China, the European Union, Japan, South Korea and Australia. The issued patents are predicted to expire between April 11, 2036 and April 21, 2042.
Previous wording
Summary of Statements of Operations for the three and nine months ended September 30, 2024 compared with the three and nine months ended September 30, 2023:
Current wording
Summary of Statements of Operations for the three months ended March 31, 2025 compared with the three months ended March 31, 2024:
Previous wording
General and administrative (“G&A”) expenses increased by approximately $0.06 million or 3% during the three months ended September 30, 2024 as compared to the three months ended September 30, 2023. The increase in G&A expense is primarily related to increase in headcount amounting to $0.02 million, higher consultants costs of $0.07 million primarily offset by lower legal costs in this quarter compared to the prior period.
Current wording
General and administrative (“G&A”) expenses decreased by approximately $0.3 million or 15% during the three months ended March 31, 2025 as compared to the three months ended March 31, 2024. The decrease in G&A expense is primarily related to decrease in non-cash stock-based compensation expense amounting to $0.5 million driven by change in estimate for recognition of milestone options offset by an increase in insurance expense of $0.1 million and commercial readiness expenses for $0.1 million.
Previous wording
Research and development expenses (“R&D”) expenses increased by approximately $1.3 million or 78% during the three months ended September 30, 2024 as compared to the three months ended September 30, 2023. The increase in R&D expense is primarily related to increase in headcount of $0.3 million and non-cash stock-based compensation expense amounting to $0.1 million associated with additional awards granted since September 30, 2023, increase of clinical and AI related costs of $0.5 million, increase in consulting spend of $0.6 million offset by decrease in product development consulting cost of $0.1 million primarily driven by completion of milestone projects in prior period.
Current wording
Research and development expenses (“R&D”) expenses increased by approximately $1.1 million or 44% during the three months ended March 31, 2025 as compared to the three months ended March 31, 2024. The increase in R&D expense is primarily related to increase in headcount of $0.6 million and non-cash stock-based compensation expense amounting to $0.4 million associated with additional awards granted since March 31, 2024, increase in product development expense of $0.5 million, offset by a decrease in clinical related costs of $0.4 million.
Previous wording
Other income during the three and nine months ended September 30, 2024 and 2024 is related to interest earned on our cash balances.
Current wording
Other income during the three months ended March 31, 2025 and 2024 is related to interest earned on our cash and short term investments.
Previous wording
We have incurred losses each year since inception and has experienced negative cash flows from operations in each year since inception. As of September 30, 2024, we have cash and cash equivalents balance of approximately $5.8 million. Based on our current business plan assumptions and expected cash burn rate, we believe that the existing cash is insufficient to fund operations for the next twelve months following the issuance of these financial statements. These factors raise substantial doubt regarding our ability to continue as a going concern.
Current wording
We have incurred losses each year since inception and have experienced negative cash flows from operations in each year since inception. As of March 31, 2025, we have cash and short-term investments of approximately $8.2 million. Based on our current business plan assumptions and expected cash burn rate, we believe that the existing cash is insufficient to fund operations for the next twelve months following the issuance of these financial statements. These factors raise substantial doubt regarding our ability to continue as a going concern.
Previous wording
Cash flows for the nine months ended September 30, 2024 and 2023 (in thousands):
Current wording
Cash flows for the three months ended March 31, 2025 and 2024 (in thousands):
Previous wording
Net cash used in our operating activities of $10.3 million during the nine months ended September 30, 2024, is primarily due to our net loss of $14.5 million less $3.3 million in non-cash expenses and $0.9 million of net changes in operating assets and liabilities.
Current wording
Net cash used in our operating activities of $4.5 million during the three months ended March 31, 2025, is primarily due to our net loss of $5.5 million less $1.1 million in non-cash expenses and $0.1 million of net changes in operating assets and liabilities.
Previous wording
Net cash used by our operating activities of $9.2 million during the nine months ended September 30, 2023, is primarily due to our net loss of $10.8 million less $2.0 million in non-cash expenses and $0.4 million of net changes in operating assets and liabilities.
Current wording
Net cash used in our operating activities of $3.5 million during the three months ended March 31, 2024, is primarily due to our net loss of $4.6 million less $1.2 million in non-cash expenses and $0.1 million of net changes in operating assets and liabilities.
Previous wording
Net cash used in investing activities during the nine months ended September 30, 2023, of $0.1 million, is primarily due to purchase of property and equipment.
Current wording
Net cash used in investing activities during the three months ended March 31, 2025, of $3.8 million is from the purchase of short-term investments.
Previous wording
Net cash used in investing activities during the nine months ended September 30, 2024 of $0.2 million, is from the purchase of property and equipment.
Current wording
Net cash used in investing activities during the three months ended March 31, 2024 of $0.1 million, is from the purchase of equipment.
Previous wording
Net cash provided by financing activities during the nine months ended September 30, 2023, of $24.9 million, is primarily from the issuance of common stock, net of issuance costs.
Current wording
During the three months ended March 31, 2025, net cash provided by financing activities of $10.3 million is primarily from net proceeds from sale of common stock, net of issuance costs.
Previous wording
There have been no material changes to our critical accounting estimates from the information provided in Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” included in our 2023 Annual Report except as covered below:
Current wording
There have been no material changes to our critical accounting estimates from the information provided in Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” included in our 2024 Annual Report.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
During the nine months ended September 30, 2024, net cash provided by financing activities during the nine months ended September 30, 2024, of $0.1 million is primarily from net proceeds from sale of equity, net of issuance costs.