HeartBeam Inc
For the period ended Sep 30, 2024. Filed Nov 7, 2024.
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Sep 30, 2024 · Filed Nov 7, 2024
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Notes to the Condensed Unaudited Financial Statements
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
NOTE 1 –ORGANIZATION AND OPERATIONS
HeartBeam, Inc. (“HeartBeam” or the “Company”) is a cardiac technology company focusing on developing and commercializing higher resolution ambulatory Electrocardiogram (“ECG”) solutions that enable the detection and monitoring of cardiac disease outside a healthcare facility setting. The Company’s ability to develop higher resolution ECG solutions is achieved through the development of the Company’s proprietary and patented Vector Electrocardiography (“VECG”) technology platform. HeartBeam’s VECG is capable of developing three-dimensional (3D) representations of cardiac electrical activity by displaying the spatial locations of ECG waveforms that demonstrated in early studies to deliver diagnostic capability equal or superior to traditional hospital-based ECG systems.
The Company has validated this technology and is seeking U.S. Food and Drug Administration (“FDA”) clearance of its initial telehealth products. The Company filed a 510(k) submission in 2023 for its initial product, a patient-held VECG device. With a planned second submission, this product will become an ambulatory device, carried by patients, which can synthesize a 12L ECG for physician review.
The Company was incorporated in 2015 as a Delaware corporation. The Company operates asone segment and its operations are based in Santa Clara, California.
NOTE 2 –GOING CONCERN AND OTHER UNCERTAINTIES
The Company is subject to a number of risks similar to those of early stage medical device companies, including dependence on key individuals and products, the inherent uncertainties with regulatory approvals, the difficulties inherent in the development of a commercial market, the potential need to obtain additional capital, competition from larger companies, other technology companies and other technologies.
The Company has incurred losses each year since inception and has experienced negative cash flows from operations in each year since inception. As of September 30, 2024 the Company has a cash and cash equivalents balance of approximately $5.8 million. Based on its current business plan assumptions and expected cash burn rate, the Company believes 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 the Company’s ability to continue as a going concern.
Therefore, the Company’s continued operations will depend on its ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships until sufficient revenue can be generated to achieve positive cash flow from operations. The Company expects no material commercial revenue in 2024.
The Company continues to maintain strong financial discipline as it achieves critical R&D, clinical and regulatory milestones in advance of commercialization. Management believes the continued achievement of these milestones will provide the Company the ability to raise additional capital. Management can provide no assurance that such financing or strategic relationships will be available on acceptable terms, or at all, which would likely have a material adverse effect on the Company and its financial statements.
On May 2, 2024, the Company entered into a Sales Agreement (“PV Sales Agreement”) with Public Ventures, LLC, as sales agent (“Public Ventures”), pursuant to which the Company may sell up to an aggregate of approximately $17 million of shares of the Company’s common stock. There were 50,000 shares issued under the At The Market (“ATM”) during the nine months ended September 30, 2024. As of September 30, 2024, there was approximately $16.9 million available for issuance under the ATM.
The accompanying unaudited condensed financial statements do not include any adjustments relating to the recoverability and classification of asset carrying amounts or the amount and classification of liabilities that may result should the Company be unable to continue as a going concern.
NOTE 3 –SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
BASIS OF PRESENTATION
The accompanying condensed unaudited financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America ("US GAAP") and in conformity with the instructions on Form 10-Q and Rule 8-03 of Regulation S-X and the related rules and regulations of the Securities and Exchange Commission (“SEC”) and have been prepared on a basis which assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. In the opinion of management, the unaudited interim condensed financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results of operations for the periods presented. The interim operating results are not necessarily indicative of results that may be expected for any subsequent period. The accompanying condensed unaudited financial statements should be read in conjunction with the Company’s audited annual financial statements and notes thereto included in the Company’s Form 10-K filed with the SEC on March 20, 2024 (“2023 Annual Report”).
CASH, CASH EQUIVALENTS AND RESTRICTED CASH
The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash deposits. The Company maintains its cash in institutions insured by the Federal Deposit Insurance Corporation (“FDIC”) and has cash balances in accounts which exceed the federally insured limits as of September 30, 2024 and December 31, 2023. The Company has made a deposit to the bank for their credit cards in the amount of $56,000 and $50,000 and is classified as restricted cash included in other assets as of September 30, 2024, and December 31, 2023, respectively.
USE OF ESTIMATES
The preparation of financial statements in conformity with US GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Due to the inherent uncertainty involved in making estimates, actual results reported in future periods may be based on amounts that differ from those estimates.
PROPERTY AND EQUIPMENT, NET
Property and equipment are stated at cost less accumulated depreciation. Depreciation of property and equipment is calculated using the straight-line method over the estimated useful lives of the assets. The Company regularly evaluates the estimated remaining useful lives of the Company’s property and equipment, net, to determine whether events or changes in circumstances warrant a revision to the remaining period of depreciation. Maintenance and repairs are expensed as incurred.
During the three months ended September 30, 2024, the Company has capitalized tools amounting to $52,200, which is being depreciated based on useful life of 7 years. Depreciation and amortization expense for the three months ended September 30, 2024 was nominal. As of September 30, 2024, property and equipment, net represents machinery and equipment of $51,600 and construction-in-progress related to tooling development that has not been placed into service is amounting to $405,000 and $256,000 as of September 30, 2024, and December 31, 2023, respectively. Construction-in-progress amounts are not subject to depreciation as such assets are not yet available for their intended use.
NET LOSS PER COMMON SHARE
Basic net loss per share excludes the effect of dilution and is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding.
Diluted net loss per share is computed by giving effect to all potential shares of common stock, including stock options and warrants to the extent dilutive. Basic net loss per share was the same as diluted net loss per share for the three and nine months ended September 30, 2024 and 2023 as the inclusion of all potential common shares outstanding would have an anti-dilutive effect.
In accordance with ASC 260-10-45-13, exercisable penny options are included in the calculation of weighted average basic and diluted earnings per share. Penny options of 178,533 and 176,105 have been included in the calculation of weighted average basic and diluted earnings per share for the three and nine months ended September 30, 2024 and September 30, 2023, respectively.
The following is a summary of awards outstanding as of September 30, 2024 and 2023, which are not included in the computation of basic and diluted weighted average shares:
| Three and Nine months endedSeptember 30, | ||
|---|---|---|
| 2024 | 2023 | |
| Stock options (excluding exercisable penny stock options) | 7,244,175 | 4,782,020 |
| Restricted stock units | 283,411 | 221,631 |
| Warrants | 5,152,397 | 5,152,397 |
| Total | 12,679,983 | 10,156,048 |
RECENTLY ISSUED ACCOUNTING STANDARDS
Not Yet Adopted as of September 30, 2024:
In November 2023, the Financial Standards Accounting Board (FASB) issued Accounting Standards Update (ASU) 2023-07 "Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures" which expands annual and interim disclosure requirements for reportable segments, primarily through enhanced disclosures about significant segment expenses. ASU 2023-07 is effective for the Company’s annual periods beginning January 1, 2024, and for interim periods beginning January 1, 2025, with early adoption permitted. The Company is evaluating the disclosure impact of the updated standard on the Company’s financial statement disclosures.
In December 2023, the FASB issued ASU 2023-09 "Income Taxes (Topics 740): Improvements to Income Tax Disclosures" to expand the disclosure requirements for income taxes, specifically related to the rate reconciliation and income taxes paid. ASU 2023-09 is effective for the Company’s annual periods beginning January 1, 2025, with early adoption permitted. The Company is currently evaluating the potential effect that the updated standard will have on the Company’s financial statement disclosures.
In March 2024, the FASB issued ASU 2024-02 “Codification Improvements – Amendments to Remove References to the Concepts Statements.” This amendments to the Codification that remove references to various Concepts Statement. The amendments in this update are effective for public business entities for fiscal years beginning after December 15, 2024. Early application of the amendments in this update is permitted for all entities, for any fiscal year or interim period for which financial statements have not yet been issued (or made available for issuance). If an entity adopts the amendments in an interim period, it must adopt them as of the beginning of the fiscal year that includes that interim period. The Company is currently evaluating the impact that the adoption of this standard will have on the Company’s financial statement disclosures.
NOTE 4 –STOCKHOLDERS’ EQUITY
WARRANTS
The following is a summary of warrant activity during the nine months ended September 30, 2024:
| Number ofshares | Weightedaverage exerciseprice | Weightedaverageremaining life (years) | Aggregateintrinsic value(in thousands) | |
|---|---|---|---|---|
| Outstanding and exercisable - December 31, 2023 | 5,152,397 | $4.71 | 3.35 | $792 |
| Exercised | — | — | — | — |
| Expired | — | — | — | — |
| Outstanding and exercisable – September 30, 2024 | 5,152,397 | $4.71 | 2.59 | $742 |
NOTE 5 –STOCK-BASED COMPENSATION
At the June 2024 annual stockholders’ meeting the 2022 Equity Incentive Plan was amended to increase the number of authorized shares from 5,900,000 shares to 8,900,000.
STOCK OPTIONS
The following is a summary of stock option activity during the nine months ended September 30, 2024:
| Number ofoptionsoutstanding | Weightedaverageexerciseprice | Averageremainingcontractual life(in years) | Aggregateintrinsic value(in thousands) | |
|---|---|---|---|---|
| Outstanding – December 31, 2023 | 6,092,525 | $2.22 | 8.7 | $2,945 |
| Options granted | 1,435,000 | 2.32 | ||
| Options exercised | (38,069) | 0.77 | ||
| Options cancelled | (66,748) | 3.54 | ||
| Outstanding – September 30, 2024 | 7,422,708 | $2.24 | 8.6 | $2,826 |
| Exercisable – September 30, 2024 | 2,147,402 | $1.96 | 7.5 | $1,534 |
The Company estimates the fair values of stock options using the Black-Scholes option-pricing model on the date of grant. For the nine months ended September 30, 2024 and 2023, the assumptions used in the Black-Scholes option pricing model, which was used to estimate the grant date fair value per option, were as follows:
| Nine Months ended September 30, | ||
|---|---|---|
| 2024 | 2023 | |
| Weighted-average Black-Scholes option pricing model assumptions: | ||
| Volatility | 125.33% - 128.85% | 110.23% - 110.64% |
| Expected term (in years) | 6.00 - 7.00 | 5.85 - 6.07 |
| Risk-free rate | 3.59% - 4.60% | 3.54% - 3.95% |
| Expected dividend yield | $— | $— |
| Weighted average grant date fair value per share | $1.81 - $2.48 | $1.75 - $3.38 |
RESTRICTED STOCK UNITS
The following is a summary of RSU’s awards activity during the nine months ended September 30, 2024:
| Numbers of Shares | Weighted Average Grant Date Fair value | |
|---|---|---|
| Non-Vested at beginning of period | 217,881 | $3.12 |
| Shares granted | 243,357 | 2.26 |
| Shares vested | (177,827) | 3.13 |
| Non-vested at the end of period | 283,411 | $2.38 |
STOCK BASED COMPENSATION
The following is a summary of stock-based compensation expense (rounded):
| Three months ended September 30, | Nine Months ended September 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| General and administrative | ||||
| Stock options | 560,000 | 589,500 | 1,898,000 | 1,352,100 |
| RSU’s | 149,000 | 153,000 | 433,000 | 323,000 |
| Total general and administrative | 709,000 | 742,500 | 2,331,000 | 1,675,100 |
| Research and development | ||||
| Stock options | 334,000 | 173,600 | 941,000 | 336,100 |
| RSU’s | 10,000 | 10,200 | 28,000 | 10,200 |
| Total research and development | 344,000 | 183,800 | 969,000 | 346,300 |
| Total | 1,053,000 | 926,300 | 3,300,000 | 2,021,400 |
During the nine months ended 2023, the Company granted 2,208,000 options to various executives and employees. Sixty percent (60%) of these options vest based on FDA Clearance for marketing of HeartBeam’s synthesized 12L product and the remaining forty percent (40%) vest monthly over a period of 48 months.
The Company calculated the fair value for each of these grants using the Black-Scholes option pricing model and the performance-based options are expensed beginning from date of grant to the expected FDA clearance, which is based on management’s probability assessment performed on a quarterly basis.
As of September 30, 2024, total compensation cost not yet recognized related to unvested stock options and unvested RSUs was approximately $8.3 million and $0.5 million, respectively, which is expected to be recognized over a weighted-average period of 2.9 years and 0.85 years, respectively.
NOTE 6 –RELATED PARTY TRANSACTIONS
During the course of business, the Company obtains accounting services from CTRLCFO, a firm in which a prior executive of the Company had significant influence. On December 29, 2023, this executive, informed the Company of his plans to retire from his position as of February 1, 2024 and as such ceased to be a related party as of February 1, 2024. The Company had balances due to this firm amounting to approximately $2,000 as of December 31, 2023.
During April 2024, the Company entered into consulting agreement withone of the independent Board of Directors to provide business development consulting services. For these consulting services, the Company agreed to pay $5,000 per month as remuneration and granted 70,000 options to vest during over a period of 36 months. During the three and nine months ended September 30, 2024, the Company recognized $25,700 and $50,200, respectively related to these consulting services, which includes stock based compensation expense of $10,700 and $20,200, respectively.
NOTE 7 –COMMITMENTS
Lease Obligations
Prior to February 1, 2024, the Company was in a month-to-month lease agreement for its headquarters. The agreement was for an undefined term that could be cancelled at any time, givenone month’s notice by either party. The Company’s monthly rent expense associated with this agreement was approximately $1,800. This headquarters lease was in the name of the Company’s Chief Executive Officer, and the cost was reimbursed monthly to CEO until January 31, 2024 when the Company terminated the month-to-month lease, and entered into a new lease in name of the Company with the same landlord. The new lease commenced on February 1, 2024, for initial period of 3 years. The Company performed an assessment and concluded that amount of operating lease right-of-use, or ROU assets was below the Company’s capitalization thresholds set in accordance with ASC 842. For the three and nine months ended September 30, 2024 rent was approximately $5,400 and $15,840, respectively. For the three and nine months ended September 30, 2023, rent expense was approximately $4,000 and $12,000, respectively.
Professional Services Agreement
In March 2022, the Company entered into a professional services agreement with Triple Ring Technologies, Inc. (“TRT”), a co-development company, to assist in the design and development of the Company’s telehealth complete solution 3D vector ECG collection device for remote heart attack or MI monitoring. This agreement was followed by several amendments. The agreement with TRT includes a commitment totaling $1.7 million. For the three and nine months ended September 30, 2024, the Company has expensed approximately $0.1 million and $0.3 million, respectively. For the three and nine months ended September 30, 2023, the Company has expensed approximately $0.3 million and $0.8 million, respectively.
As of September 30, 2024, the Company has a remaining commitment of $0.1 million.
Clinical Research Organization
On March 8, 2024, the Company has entered into an agreement with Clinical Research Organization (CRO) to perform certain services related to project set up, clinical trial management and monitoring during next six months. As per terms of the agreement, the Company will pay CRO approximately $0.5 million for these services. Additionally, the Company has signed a Clinical Study Agreement with first offive sites to carry out the clinical study for which CRO will act as Company sponsor in relation to payment for these services. The total cost of the clinical trial including the CRO cost is expected to approximate $0.9 million. For the three months and nine months ended September 30, 2024, the Company has expensed $0.1 million and $0.7 million based on actual services performed by the CRO and clinical sites, of which $0.1 million was accrued as of September 30, 2024. As of September 30, 2024, the Company has a remaining commitment of $0.1 million.
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