NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
NOTE 1 – ORGANIZATION AND OPERATIONS
HeartBeam, Inc. (“HeartBeam” or “Company”) is a development-stage company specializing in cardiovascular diagnostic technology. The Company was incorporated in 2015 as a Delaware corporation. The Company’s operations are based in Santa Clara, California and it operates in one segment.
HeartBeam’s initial focus is on timely diagnosis of a heart attack. The Company’s technology provides physicians with complete cardiac diagnostic information for a patient that is outside of a medical institution. The Electrocardiogram (“ECG”) collection device is the size of a credit card. The device sends ECG signals to the patient's smartphone and on to a cloud-based software expert system. Results of the cloud-based analysis are presented to a qualified health care professional for immediate action including, if necessary, a telehealth visit. The Company has validated this novel technology in three clinical studies and is preparing to seek U.S. Food and Drug Administration (“FDA”) clearance of its initial products late 2022 and early 2023. Clearance for the Emergency Department (“ED”) product, HeartBeam AIMI (TM) is scheduled for late 2022, submission of the telehealth product, HeartBeam AIMIGo (TM) is scheduled for late 2022 with clearance in early 2023.
On September 27, 2021, the Company filed a certificate of amendment to its amended and restated certificate of incorporation with the Secretary of State of the State of Delaware to effect a 1-for-2.75 reverse stock split of its outstanding shares of common stock. As a result of the reverse stock split, every 2.75 shares of the Company’s outstanding pre-reverse split common stock were combined and reclassified into one share of common stock. Unless otherwise noted, all share and per share data included in these condensed unaudited financial statements retroactively reflect the 1-for-2.75 reverse stock split.
NOTE 2 – LIQUIDITY, GOING CONCERN AND OTHER UNCERTAINTIES
The Company is subject to a number of risks similar to those of early stage companies, including dependence on key individuals and products, 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 June 30, 2022 and December 31, 2021, the Company had an accumulated deficit of approximately $14,895,000 and $9,224,000, respectively. Based on our current business plan assumptions and the 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 condensed unaudited financial statements. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern.
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 and revenue. Revenue is expected following FDA clearance of our initial two products. 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.
The condensed unaudited 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 might result should the Company be unable to continue as a going concern.
On January 30, 2020, the World Health Organization (“WHO”) announced a global health emergency, a result of coronavirus (“COVID-19 outbreak”) and the risks to the international community. In March 2020, the WHO classified the COVID-19 outbreak as a pandemic, based on the rapid increase in exposure globally. Developments such as social distancing and shelter-in-place directives were effected impacting the Company’s operations. While the restrictions have eased, the risk continues as new variants are being discovered, and although certain changes in telehealth benefits may be favorable to the Company, these disruptions may negatively impact the Company’s results of operations and liquidity beyond 2022.
NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
BASIS OF PRESENTATION
The accompanying condensed unaudited financial statements have been prepared in conformity with US Generally Accepted Accounting Principles ("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 financial statements and notes thereto included in the Company’s Form 10-K filed with the SEC on March 24, 2022 (“2021 Annual Report”).
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.
ACCOUNTING FOR WARRANTS
The Company classifies as equity any contracts that (i) require physical settlement or net-share settlement or (ii) gives the Company a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement). The Company classifies as assets or liabilities any contracts that (i) require net-cash settlement (including a requirement to net cash settle the contract if an event occurs and if that event is outside the control of the Company) or (ii) gives the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement). The Company accounts for its currently issued warrant instruments in conjunction with the Company’s common stock in permanent equity. These warrants are indexed to the Company’s stock and meet the requirements of equity classification as prescribed under ASC 815. Warrants classified as equity are initially measured at fair value, and subsequent changes in fair value are not recognized so long as the warrants continue to be classified as equity.
STOCK-BASED COMPENSATION
The Company periodically issues stock options and restricted stock awards (“RSU’s”) to employees and non-employees for services. The Company has adopted ASU 2018-07 which expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from non-employees. The Company accounts for such grants issued and vesting to employees and non-employees based on ASC 718, whereby the value of the award is measured on the date of grant and recognized as compensation expense over the vesting period.
The Company grants certain option holders the right to early exercise, as of June 30, 2022, 10,236 options remain unvested. These early exercised grants are not considered an expense or included in either shares outstanding or weighted average shares outstanding until vested.
The fair value of stock options on the date of grant is calculated using the Black-Scholes option pricing model, based on key assumptions such as the fair value of common stock, expected volatility and expected term. These estimates require the input of subjective assumptions, including (i) the expected stock price volatility, (ii) the calculation of the expected term of the award, (iii) the risk-free interest rate and (iv) expected dividends. These assumptions are primarily based on third-party valuations, historical data, peer company data and the judgment of management regarding future trends and other factors. The Company has estimated the expected term of its employee stock options using the “simplified” method, whereby, the expected term equals the arithmetic average of the vesting term and the original contractual term of the option due to its lack of sufficient historical data. The risk-free interest rates for periods within the expected term of the option are based on the US Treasury securities with a maturity date commensurate with the expected term of the associated award. The Company has never paid and does not expect to pay dividends in the foreseeable future. The Company accounts for
forfeitures when they occur. Stock-based compensation expense recognized in the financial statements is reduced by the actual awards forfeited.
Compensation cost for restricted stock awards issued to employees and non-employees is measured using the grant date fair value of the award, and expense is recognized over the service period, adjusted to reflect actual forfeitures.
RESEARCH AND DEVELOPMENT EXPENSE
The Company expenses the cost of research and development as incurred. Research and development expenses consist primarily of professional services costs associated with the development of cardiovascular technologies and products.
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 six months ended June 30, 2022 and 2021 as the inclusion of all potential common shares outstanding would have an anti-dilutive effect.
As of June 30, 2022, the penny warrants issued during 2019 have been excluded from the net loss per common share calculation following ASC 260-1-25-12A (Treatment of Contingently Issuable Shares in Weighted-Average Shares Outstanding) as there are circumstances under which these shares would not be issued and therefore not exercisable, (see NOTE 4).
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. As of June 30, 2022, 170,149 penny options have been included in the calculation of weighted average basic and diluted earnings per share.
The following is a summary of awards outstanding as of June 30, 2022 and 2021, which are not included in the computation of basic and diluted weighted average shares:
| | | | | | | | | | | | | | | | | |
| | | Three and Six months ended June 30, |
| | | | 2022 | | 2021 |
Stock options (excluding exercisable penny stock options) | | | | | 1,868,218 | | | 569,875 | |
Restricted stock awards | | | | | 22,500 | | | — | |
Convertible debt | | | | | — | | | 2,718,023 | |
Warrants | | | | | 3,908,276 | | | 422,549 | |
Total | | | | | 5,798,994 | | | 3,710,447 | |
NOTE 4 – STOCKHOLDERS’ EQUITY
COMMON STOCK
On January 14, 2022, the Company issued 78,025 shares of Common Stock to a consulting firm for services that were related to the IPO that was consummated in the prior year. The Company calculated the value of the common stock using closing stock price on November 11, 2021, resulting in a fair value of approximately $365,000. The Company also issued 72,727 warrants, the calculated fair value of the warrants was of $1.25 each, using the Black-Scholes option pricing model on the date the consulting firm achieved the milestone, using the following assumptions: (a) fair value of $2.28 per share, (b) expected volatility of 90.81%, (c) dividend yield of 0%, (d) risk-free interest rate of 0.87%, and (e) expected life of 5 years, resulting in the fair value of approximately $91,000.
On February 18, 2022, the Company entered into a stock purchase agreement pursuant to which the Company agreed to issue and sell to OpenSky Opportunities Fund Ltd. an aggregate of 58,000 units consisting of one share of Common Stock and Warrants to purchase one share of Common Stock at a combined price of $6.00 per unit. The Common Stock and the Warrants were immediately separable and issued separately but were purchased together in the Private Placement. The
Warrants will have a per share exercise price of $6.00 and are exercisable immediately subject to a 180-Day lock up. The Warrants will expire five years from the date of issuance. The Company received $348,000 in proceeds from the sale. The Company paid no underwriting discounts or commissions.
During the three and six months ended June 30, 2022 the Company issued shares of common stock upon exercise of vested stock options and restricted stock awards of 23,120 and 36,071, respectively. The Company received proceeds of a de minimis amount for the exercise of stock options.
WARRANTS
On February 28, 2022, the Company issued 58,000 warrants to purchase 58,000 shares of common stock at an exercise price of $6.00 per share.
On January 14, 2022, the Company issued 72,727 warrants based on performance metrics achieved in 2021 to purchase 72,727 shares of common stock at an exercise price of $5.50 per share, with an expiration of five years from the date of issuance.
The following is a summary of warrant activity during the six months ended June 30, 2022:
| | | | | | | | | | | | | | | | | | | | | | | |
| Number of shares | | Weighted average exercise price | | Weighted average remaining life (years) | | Aggregate intrinsic value (in thousands) |
Outstanding - December 31, 2021 | 3,777,549 | | | $ | 5.42 | | | 4.45 | | $ | 1,259 | |
Issued | 130,727 | | | 5.72 | | | — | | — | |
| | | | | | | |
Outstanding – June 30, 2022 | 3,908,276 | | | 5.43 | | | 3.97 | | $ | 525 | |
Exercisable – June 30, 2022 | 3,501,004 | | | $ | 6.06 | | | 4.36 | | $ | — | |
NOTE 5 – STOCK-BASED COMPENSATION
In 2015, the Company’s Board of Directors approved the HeartBeam, Inc. 2015 Equity Incentive Plan ("2015 Plan"), to attract and retain the best available personnel for positions of substantial responsibility, to provide additional incentive to employees, directors, and consultants, and to promote the success of the Company’s business. The 2015 Plan provides for the grant of stock options and RSU’s to purchase common stock of which 1,636,362 were authorized by the board of which 1,325,867 are outstanding. The 2015 Plan was terminated upon shareholder approval of the 2022 Equity Incentive Plan (“2022 Plan”) whereby no awards can be issued under the 2015 Plan.
The Company’s shareholders approved the 2022 Plan at the annual meeting of stockholders held on June 15, 2022, pursuant to which 1,900,000 shares of common stock was authorized for issuance. As of June 30, 2022, there were 1,165,000 shares available for issuance under the 2022 Equity Plan.
As of June 30, 2022 and 2021, the Company received proceeds of a de minimis amount from the exercise of stock options.
STOCK OPTIONS
The following is a summary of stock option activity during the six months ended June 30, 2022:
| | | | | | | | | | | | | | | | | | | | | | | |
| Number of options outstanding | | Weighted average exercise price (*) | | Average remaining contractual life (in years) | | Aggregate intrinsic value (in thousands) |
| | | | | | | |
Outstanding – December 31, 2021 | 1,105,938 | | | $ | 2.03 | | | 8.8 | | $ | 1,535 | |
Options granted | 961,000 | | | 1.39 | | | | | |
Options exercised | (28,571) | | | — | | | | | |
| | | | | | | |
Outstanding – June 30, 2022 | 2,038,367 | | | 1.72 | | | 8.9 | | 499 | |
Exercisable – June 30, 2022 | 451,133 | | | $ | 0.89 | | | 7.7 | | $ | 366 | |
(*) $ - Indicates exercise price less than $0.01 per share
During the three months ended June 30, 2022 the Company modified options to purchase 63,636 shares of common stock with an exercise price of $2.80 to an exercise price of $1.60. The total incremental cost of the modification was de minimis.
The Company estimates the fair values of stock options using the Black-Scholes option-pricing model on the date of grant. For the six months ended June 30, 2022 and 2021, 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:
| | | | | | | | | | | |
| Six months ended June 30, |
| 2022 | | 2021 |
Weighted-average Black-Scholes option pricing model assumptions: | | | |
Volatility | 107.25% - 110.98% | | 76.8% - 76.9% |
Expected term (in years) | 5.73 - 5.80 | | 5.66 |
Risk-free rate | 1.47% - 2.85% | | 0.48% - 0.82% |
Expected dividend yield | — | | | — | |
Weighted average grant date fair value per share | $1.08 - $1.75 | | $1.59 - $1.81 |
RESTRICTED STOCK UNITS
The following is a summary of RSU’s awards activity during the six months ended June 30, 2022:
| | | | | | | | | | | | | | |
| | Six months ended June 30, 2022 |
| | Numbers of Shares | | Weighted Average Grant Date Fair value |
Non-Vested at beginning of period | | 30,000 | | | $ | 3.20 | |
Shares vested | | 7,500 | | | 3.20 | |
Non-vested | | 22,500 | | | $ | 3.20 | |
STOCK BASED COMPENSATION
The following is a summary of stock-based compensation expense:
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three months ended June 30, | | Six months ended June 30, | | |
| 2022 | | 2021 | | 2022 | | 2021 | | | | |
General and administration | | | | | | | | | | | |
Stock options | 175,900 | | | 21,000 | | | 296,800 | | | 26,000 | | | | | |
RSU’s | 23,100 | | | — | | | 35,000 | | | — | | | | | |
Total general and administration | 199,000 | | | 21,000 | | | 331,800 | | | 26,000 | | | | | |
R&D | | | | | | | | | | | |
Stock options | 64,800 | | | 2,400 | | | 90,900 | | | 6,000 | | | | | |
Total | $ | 263,800 | | | $ | 23,400 | | | $ | 422,700 | | | $ | 32,000 | | | | | |
As of June 30, 2022, total compensation cost not yet recognized related to unvested stock options was approximately $2.4 million, which is expected to be recognized over a weighted-average period of 3.22 years.
As of June 30, 2022, total compensation cost not yet recognized related to unvested RSU’s is approximately $61,000, which is expected to be recognized over a weighted-average period of 1.3 years.
NOTE 6 – RELATED PARTY TRANSACTIONS
During the course of business, the Company obtains accounting services from CTRLCFO, a firm in which an executive of the Company has significant influence, as well as Hardesty, where he is a non-managing partner. The Company incurred accounting fees from these firms of approximately $4,000 and $11,000 during the three and six months ended June 30, 2022, respectively, and approximately $32,000 and $55,000 during the three and six months ended June 30, 2021. The Company had balances due to these firms amounting to approximately $1,000 as of June 30, 2022 and December 31, 2021.
NOTE 7 – COMMITMENTS AND CONTINGENCIES
On May 1, 2019, the Company entered into a month to month lease agreement for our headquarters. The agreement is for an undefined term and can be cancelled at any time, given one month’s notice by either party. The Company’s monthly rent expense associated with this agreement is approximately $1,440. The Company’s month to month headquarters lease is in the name of the Company’s Chief Executive Officer, and the cost is reimbursed monthly.
For the three and six months ended June 30, 2022 and 2021, rent expense was approximately $4,000 and $8,000 respectively for each year.
On January 31, 2022, the Company entered into a partnership agreement with LIVMOR Inc. (“LIVMOR”) to build a Company-branded version of the LIVMOR’s Halo+ FDA cleared turnkey solution for RPM to connect physicians and patients. As included in the agreement, the Company and LIVMOR have the right to enter into additional agreements as needed in order to further the Company’s development of its products. The agreement with LIVMOR includes a commitment in 2022 of $1.0 million. As of June 30, 2022 LIVMOR accepted the committed $1.0 million payment, of which $0.9 million has been incurred as R&D expense and $0.1 million is included in prepaid expenses.
On March 7, 2022, the Company entered into a professional services agreement with Triple Ring Technologies, Inc, 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. The agreement with Triple Ring includes a commitment in 2022 of approximately $2.0 million. The Company has expensed $0.8 million and $0.1 million is included in accrued expenses as of June 30, 2022.
NOTE 8 – SUBSEQUENT EVENTS
On July 13, 2022, following the approval of the 2022 Plan, the Company filed its Registration Statement on Form S-8, pursuant to which the Company issued RSU’s to the Board of Directors totaling 238,970 units.
On August 2, 2022, the Company entered into a supplemental agreement to the partnership agreement dated January 31, 2022 with LIVMOR.
The supplemental agreement states the Company will pay an additional $200,000 for the source code access under the partnership agreement. Payments totaling $200,000 have been made by the Company and LIVMOR has delivered to the Company copies of source materials and codes. All licenses granted by LIVMOR will automatically be converted into a non-exclusive and perpetual license and become licenses granted on a royalty-free and fully paid-up basis, in which LIVMOR hereby expressly waives and relinquishes all HeartBeam payment obligations under the initial partnership agreement.