1 unchanged sentence
Evaluation of Disclosure Controls and Procedures
−Removed: Our Chief Executive Officer,
−Removed: who is our principal executive officer, and our Chief Financial Officer, who is our principal financial officer, evaluated the effectiveness
−Removed: of our disclosure controls and procedures as of December 31, 2021.
−Removed: The term “disclosure controls and procedures,” as
−Removed: defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed
−Removed: to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed,
−Removed: summarized and reported within the time periods specified in the SEC’s rules and forms.
−Removed: Disclosure controls and procedures
−Removed: include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports
−Removed: that we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer
−Removed: and our Chief Financial Officer, to allow timely decisions regarding required disclosure.
−Removed: Based on this evaluation, our Chief Executive
−Removed: Officer and our Chief Financial Officer concluded that our disclosure controls and procedures were effective as of December 31, 2021.
+Added: Our Chief Executive Officer, who is our principal
+Added: executive officer, and our Chief Financial Officer, who is our principal financial officer, evaluated the effectiveness of our disclosure
+Added: controls and procedures as of December 31, 2022.
+Added: The term “disclosure controls and procedures,” as defined in Rules 13a-15(e)
+Added: and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required
+Added: to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within
+Added: the time periods specified in the SEC’s rules and forms.
+Added: Disclosure controls and procedures include, without
+Added: limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or
+Added: submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and our Chief Financial
+Added: Officer, to allow timely decisions regarding required disclosure.
+Added: Based on this evaluation, our Chief Executive Officer and our Chief
+Added: Financial Officer concluded that our disclosure controls and procedures were effective as of December 31, 2022.
Management’s Annual Report on Internal Control Over Financial
−Removed: This annual report does not
−Removed: include a report of management’s assessment regarding internal control over financial reporting or an attestation report of the
−Removed: company’s registered public accounting firm due to a transition period established by rules of the Securities and Exchange Commission
−Removed: for newly public companies.
−Removed: Our independent registered
−Removed: public accounting firm will not be required to formally attest to the effectiveness of our internal controls over financial reporting
−Removed: for as long as we are an “emerging growth company” pursuant to the provisions of the Jumpstart Our Business Startups Act.
+Added: Our management is responsible for establishing
+Added: and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange
+Added: Our Chief Executive Officer and our Chief Financial Officer assessed the effectiveness of our internal control over financial reporting
+Added: as of December 31, 2022.
+Added: In making this assessment, our Chief Executive Officer and our Chief Financial Officer used the criteria
+Added: set forth by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO, in Internal Control—Integrated Framework.
+Added: Based on that assessment and using the COSO criteria, our Chief Executive Officer and our Chief Financial Officer have concluded that,
+Added: as of December 31, 2022, our internal control over financial reporting was effective.
+Added: Our independent registered public accounting firm
+Added: will not be required to formally attest to the effectiveness of our internal controls over financial reporting for as long as we are an
+Added: “emerging growth company” pursuant to the provisions of the Jumpstart Our Business Startups Act.
Changes in Internal Control Over Financial Reporting
−Removed: There have been no changes
−Removed: in our internal control over financial reporting during the year ended December 31, 2021, that has materially affected, or is reasonably
−Removed: likely to materially affect, our internal control over financial reporting.
+Added: There have been no changes in our internal control
+Added: over financial reporting during the year ended December 31, 2022, that has materially affected, or is reasonably likely to materially
+Added: affect, our internal control over financial reporting.
Inherent Limitations of Controls
−Removed: Management does not expect
−Removed: that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect all errors and all
−Removed: Controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives
−Removed: and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
−Removed: of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and
−Removed: instances of fraud, if any, within the Company have been detected.
−Removed: These inherent limitations include the realities that judgments in
−Removed: decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake.
−Removed: Additionally, controls can be circumvented
−Removed: by the individual acts of some persons, by collusion of two or more people, or by management override of the controls.
−Removed: The design of any
−Removed: system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance
−Removed: that any design will succeed in achieving its stated goals under all potential future conditions.
−Removed: Over time, controls may become inadequate
−Removed: because of changes in conditions, or deterioration in the degree of compliance with the policies or procedures.
+Added: Management does not expect that our disclosure
+Added: controls and procedures or our internal control over financial reporting will prevent or detect all errors and all fraud.
+Added: procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management
+Added: necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Because of the inherent
−Removed: limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
+Added: limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of
+Added: fraud, if any, within the Company have been detected.
+Added: These inherent limitations include the realities that judgments in decision-making
+Added: can be faulty, and that breakdowns can occur because of a simple error or mistake.
+Added: Additionally, controls can be circumvented by the individual
+Added: acts of some persons, by collusion of two or more people, or by management override of the controls.
+Added: The design of any system of controls
+Added: also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will
+Added: succeed in achieving its stated goals under all potential future conditions.
+Added: Over time, controls may become inadequate because of changes
+Added: in conditions, or deterioration in the degree of compliance with the policies or procedures.
+Added: Because of the inherent limitations in a
+Added: cost-effective control system, misstatements due to error or fraud may occur and not be detected.
OTHER INFORMATION
2 unchanged sentences
Not applicable.
−Removed: DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE
+Added: DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required by this item is hereby
−Removed: incorporated by reference to our definitive proxy statement for our 2022 annual meeting of stockholders to be filed with the Securities
−Removed: and Exchange Commission within 120 days of the fiscal year ended December 31, 2021.
−Removed: Our Board of Directors has adopted a written Code
−Removed: of Business Conduct and Ethics applicable to all officers, directors and employees, which is available on our website (bluejaydx.com)
−Removed: under “Governance Overview” within the “Investor Relations” section.
−Removed: We intend to satisfy the disclosure requirement
−Removed: under Item 5.05 of Form 8-K regarding amendment to, or waiver from, a provision of this Code and by posting such information on the website
−Removed: address and location specified above.
+Added: incorporated by reference to our definitive proxy statement for our 2023 annual meeting of stockholders to be filed with the SEC within
+Added: 120 days of the fiscal year ended December 31, 2022.
EXECUTIVE COMPENSATION
The information required by this item is hereby
−Removed: incorporated by reference to our definitive proxy statement for our 2022 annual meeting of stockholders to be filed with the Securities
−Removed: and Exchange Commission within 120 days of the fiscal year ended December 31, 2021.
−Removed: SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS
−Removed: AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
+Added: incorporated by reference to our definitive proxy statement for our 2023 annual meeting of stockholders to be filed with the SEC within
+Added: 120 days of the fiscal year ended December 31, 2022.
+Added: SECURITY OWNERSHIP OF CERTAIN
+Added: BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The information required by this item is hereby
1 unchanged sentence
and Exchange Commission within 120 days of the fiscal year ended December 31, 2022.
−Removed: Securities Authorized for Issuance under Equity Compensation
+Added: Securities Authorized for Issuance under Equity Compensation Plans
The following table sets forth information regarding
12 unchanged sentences
Equity compensation plans not approved by security holders (2)
−Removed: (1) Represents shares of common stock issuable upon exercise of outstanding stock options and rights under our 2018 and 2021 Stock Plans.
−Removed: (2) Consists of warrants issued to placement agents, underwriters
−Removed: and consultants.
−Removed: CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS,
−Removed: AND DIRECTOR INDEPENDENCE
−Removed: The information required by this item is hereby incorporated by reference
−Removed: to our definitive proxy statement for our 2022 annual meeting of stockholders to be filed with the Securities and Exchange Commission
−Removed: within 120 days of the fiscal year ended December 31, 2021.
+Added: (1) Represents shares of common stock
+Added: issuable upon exercise of outstanding stock options and rights under our 2018 Stock Incentive Plan (the “2018 Plan”) and
+Added: 2021 Stock Plan (the “2021 Plan”).
+Added: Both plans permit the Company to grant incentive and nonqualified stock options for the
+Added: purchase of common stock, and restricted stock awards.
+Added: The maximum number of shares of common stock reserved for issuance under the 2018
+Added: Plan and 2021 Plan are 629,440 and 1,960,000, respectively.
+Added: At December 31, 2022 there were 262,269 and 1,339,721 shares of common stock
+Added: available for grant under the 2018 Plan and 2021 Plan, respectively.
+Added: (2) Consists of warrants issued to
+Added: placement agents, underwriters and consultants.
+Added: CERTAIN RELATIONSHIPS AND RELATED
+Added: TRANSACTIONS, AND DIRECTOR INDEPENDENCE
+Added: The information required by this item is hereby
+Added: incorporated by reference to our definitive proxy statement for our 2023 annual meeting of stockholders to be filed with the SEC within
+Added: 120 days of the fiscal year ended December 31, 2022.
PRINCIPAL ACCOUNTANT FEES AND SERVICES
−Removed: The information required by this item is hereby incorporated by reference
−Removed: to our definitive proxy statement for our 2022 annual meeting of stockholders to be filed with the Securities and Exchange Commission
−Removed: within 120 days of the fiscal year ended December 31, 2021.
+Added: The information required by this item is hereby
+Added: incorporated by reference to our definitive proxy statement for our 2023 annual meeting of stockholders to be filed with the SEC within
+Added: 120 days of the fiscal year ended December 31, 2022.
EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
−Removed: (a) The following documents
−Removed: are filed as part of this report:
+Added: (a) The following documents are filed as part
+Added: of this report:
(1) Financial Statements—See
−Removed: Index to Consolidated Financial Statements at Part II, Item 8 on page F-1 of this Annual
−Removed: Report on Form 10-K.
−Removed: All financial statement schedules have been omitted because they are not applicable or not required or because the information is included elsewhere in the financial statements or the Notes thereto.
−Removed: See the accompanying Index to Exhibits filed as a part of this Annual Report, which list is incorporated by reference in this Item.
−Removed: (b) See the accompanying Index
−Removed: to Exhibits filed as a part of this Annual Report.
−Removed: (c) Other schedules are not
+Added: Index to Consolidated Financial Statements at Part II, Item 8 on page F-1 of this Form 10-K.
+Added: (2) All financial statement schedules
+Added: have been omitted because they are not applicable or not required or because the information is included elsewhere in the financial statements
+Added: or the Notes thereto.
+Added: (3) See the accompanying Index to
+Added: Exhibits filed as a part of this Form 10-K, which list is incorporated by reference in this Item.
+Added: (b) See the accompanying Index to Exhibits filed
+Added: as a part of this Form 10-K.
+Added: (c) Other schedules are not applicable.
+Added: INDEX TO EXHIBITS
+Added: Description of Document
+Added: Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Company’s Registration Statement on Form S-1 (File No.
+Added: 333-260029), filed on October 4, 2021).
+Added: Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to the Company’s Registration Statement on Form S-1 (File No.
+Added: 333-260029), filed on October 4, 2021).
+Added: Specimen Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form S-1 (File No.
+Added: 333-260029), filed on October 4, 2021).
+Added: Form of Class A Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K (File No.
+Added: 001-41031), filed on November 16, 2021).
+Added: Form of Class B Warrant (incorporated by reference to Exhibit 4.3 to the Company’s Registration Statement on Form S-1 (File No.
+Added: 333-260029), filed on October 4, 2021).
+Added: Form of Warrant Agency Agreement (incorporated by reference to Exhibit 4.4 to the Company’s Registration Statement on Form S-1 (File No.
+Added: 333-260029), filed on October 4, 2021).
+Added: Form of IPO Underwriters’ Warrant (incorporated by reference to Exhibit 4.5 to the Company’s Registration Statement on Form S-1 (File No.
+Added: 333-260029), filed on October 4, 2021).
+Added: Description of Securities of Bluejay Diagnostics, Inc.
+Added: (incorporated by reference to Exhibit 4.6 to the Company’s annual report on Form 10-K for the year ended December 31, 2021.
+Added: 2021 Stock Plan (incorporated by reference to Exhibit 10.1 to the Company’s Registration Statement on Form S-1 (File No.
+Added: 333-260029), filed on October 4, 2021).
+Added: License and Supply Agreement, dated October 6, 2020, by and between Toray Industries, Inc.
+Added: and Bluejay Diagnostics, Inc.
+Added: (incorporated by reference to Exhibit 10.2 to the Company’s Registration Statement on Form S-1 (File No.
+Added: 333-260029), filed on October 4, 2021).
+Added: Employment Agreement, dated July 1, 2021, between Neil Dey and Bluejay Diagnostics, Inc.
+Added: (incorporated by reference to Exhibit 10.3 to the Company’s Registration Statement on Form S-1 (File No.
+Added: 333-260029), filed on October 4, 2021).
+Added: Employment Agreement, dated July 1, 2021, between Gordon Kinder and Bluejay Diagnostics, Inc.
+Added: (incorporated by reference to Exhibit 10.4 to the Company’s Registration Statement on Form S-1 (File No.
+Added: 333-260029), filed on October 4, 2021).
+Added: Employment Agreement, dated July 1, 2021, between Jason Cook and Bluejay Diagnostics, Inc.* (incorporated by reference to Exhibit 10.5 to the Company’s Registration Statement on Form S-1 (File No.
+Added: 333-260029), filed on October 4, 2021).
+Added: Employment Agreement, dated July 1, 2021, between Kevin Vance and Bluejay Diagnostics, Inc.
+Added: (incorporated by reference to Exhibit 10.6 to the Company’s Registration Statement on Form S-1 (File No.
+Added: 333-260029), filed on October 4, 2021).
+Added: Securities Purchase Agreement, dated June 7, 2021, between certain purchasers and Bluejay Diagnostics, Inc.
+Added: (incorporated by reference to Exhibit 10.7 to the Company’s Registration Statement on Form S-1 (File No.
+Added: 333-260029), filed on October 4, 2021).
+Added: Registration Rights Agreement, dated June 7, 2021, between certain purchasers and Bluejay Diagnostics, Inc.
+Added: (incorporated by reference to Exhibit 10.8 to the Company’s Registration Statement on Form S-1 (File No.
+Added: 333-260029), filed on October 4, 2021).
+Added: Amendment to License and Supply Agreement, dated July 21, 2021, by and between Toray Industries, Inc.
+Added: and Bluejay Diagnostics, Inc.
+Added: (incorporated by reference to Exhibit 10.9 to the Company’s Registration Statement on Form S-1 (File No.
+Added: 333-260029), filed on October 4, 2021).
+Added: First Amendment to Employment Agreement, dated January 27, 2023, between Neil Dey and Bluejay Diagnostics, Inc.
+Added: (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K (File No.
+Added: 001-41031), filed on January 27, 2023).
+Added: Code of Ethics (incorporated by reference to Exhibit 14.1 to the Company’s Registration Statement on Form S-1 (File No.
+Added: 333-260029), filed on October 4, 2021).
+Added: List of Subsidiaries (incorporated by reference to Exhibit 21.1 to the Company’s Registration Statement on Form S-1 (File No.
+Added: 333-260029), filed on October 4, 2021).
+Added: Certification of Principal Executive Officer pursuant to Rule 13a-14 of the Securities Exchange Act of 1934, as amended
+Added: Certification of Principal Financial Officer pursuant to Rule 13a-14 of the Securities Exchange Act of 1934, as amended
+Added: Certification of Principal Executive Officer Pursuant to Section 18 U.S.C.
+Added: Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
+Added: Certification of Principal Financial Officer Pursuant to Section 18 U.S.C.
+Added: Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
+Added: Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document)
+Added: Inline XBRL Taxonomy Extension Schema Document
+Added: Inline XBRL Taxonomy Extension Calculation Linkbase Document
+Added: Inline XBRL Taxonomy Extension Definition Linkbase Document
+Added: Inline XBRL Taxonomy Extension Label Linkbase Document
+Added: Inline XBRL Taxonomy Extension Presentation Linkbase Document
+Added: Cover Page Interactive Data File (formatted as Inline XBRL and included in Exhibit 101)
+Added: ** Management
+Added: contract or compensatory plan, contract or arrangement.
FORM 10-K SUMMARY.
−Removed: Pursuant to the requirements of Section 13 or 15(d) of the Securities
−Removed: Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
−Removed: duly authorized on March 10, 2022.
+Added: Pursuant to the requ irements
+Added: of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed
+Added: on its behalf by the undersigned, thereunto duly authorized on March 20, 2023.
Bluejay Diagnostics, Inc.
Chief Executive Officer and Director
−Removed: Pursuant to the requirements of the Securities
−Removed: Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and
−Removed: on the dates indicated.
+Added: to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the
+Added: registrant and in the capacities and on the dates indicated.
Director and Chief Executive Officer
(Principal Executive Officer)
−Removed: March 10, 2022
−Removed: /s/ Gordon Kinder
−Removed: Gordon Kinder
−Removed: Chief Financial Officer
+Added: Kenneth Fisher
+Added: Financial Officer
+Added: Kenneth Fisher
(Principal Financial and Accounting Officer)
−Removed: March 10, 2022
−Removed: /s/ Douglas C.
Chairman of the Board of Directors
March 20, 2023
−Removed: /s/ Donald R.
March 20, 2023
−Removed: /s/Svetlana Dey
March 20, 2023
−Removed: March 10, 2022
−Removed: /s/ Gary Gemignani
Gary Gemignani
−Removed: March 10, 2022
+Added: Gary Gemignani
Index to Consolidated Financial Statements
9 unchanged sentences
Opinion on the Financial Statements
−Removed: We have audited the accompanying consolidated balance sheets of Bluejay
−Removed: Diagnostics, Inc.
−Removed: (the Company) as of December 31, 2021 and 2020, the related consolidated statements of operations, stockholders’
−Removed: equity (deficit) and cash flows for the years then ended, and the related notes to the consolidated financial statements (collectively,
−Removed: the “financial statements”).
−Removed: In our opinion, the financial statements present fairly, in all material respects, the financial position of
−Removed: the Company as of December 31, 2021 and 2020, and the results of its operations and its cash flows for the years then ended, in conformity
−Removed: with accounting principles generally accepted in the United States of America.
+Added: We have audited the accompanying consolidated
+Added: balance sheets of Bluejay Diagnostics, Inc.
+Added: (the Company) as of December 31, 2022 and 2021, the related consolidated statements of operations,
+Added: stockholders’ equity (deficit) and cash flows for the years then ended, and the related notes to the consolidated financial statements
+Added: (collectively, the “financial statements”).
+Added: In our opinion, the financial statements present fairly, in all material respects,
+Added: the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for the years
+Added: then ended, in conformity with accounting principles generally accepted in the United States of America.
+Added: Uncertainty Relating to Going Concern
+Added: The accompanying financial statements have been
+Added: prepared assuming that the Company will continue as a going concern.
+Added: As discussed in Note 1 to the financial statements, the Company has
+Added: incurred net losses since its inception, and has negative cash flows from operations and will need additional funding to complete planned
+Added: development efforts.
+Added: This raises substantial doubt about the Company's ability to continue as a going concern.
+Added: Management's plans in regard
+Added: to these matters also are described in Note 1.
+Added: The financial statements do not include any adjustments that might result from the outcome
+Added: of this uncertainty.
Basis for Opinion
−Removed: These financial statements are the responsibility of the Company’s
−Removed: Our responsibility is to express an opinion on the Company’s financial statements based on our audits.
−Removed: We are a public
−Removed: accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent
−Removed: with respect to the Company in accordance with U.S.
−Removed: federal securities laws and the applicable rules and regulations of the Securities
−Removed: and Exchange Commission and the PCAOB.
−Removed: We conducted our audits in accordance with the standards of the PCAOB.
−Removed: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free
−Removed: of material misstatement, whether due to error or fraud.
−Removed: The Company is not required to have, nor were we engaged to perform, an audit
−Removed: of its internal control over financial reporting.
−Removed: As part of our audits we are required to obtain an understanding of internal control
−Removed: over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control
−Removed: over financial reporting.
+Added: These financial statements are the responsibility
+Added: of the Company’s management.
+Added: Our responsibility is to express an opinion on the Company’s financial statements based on our
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are
+Added: required to be independent with respect to the Company in accordance with U.S.
+Added: federal securities laws and the applicable rules and regulations
+Added: of the Securities and Exchange Commission and the PCAOB.
+Added: We conducted our audits in accordance with the
+Added: standards of the PCAOB.
+Added: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
+Added: statements are free of material misstatement, whether due to error or fraud.
+Added: The Company is not required to have, nor were we engaged
+Added: to perform, an audit of its internal control over financial reporting.
+Added: As part of our audits, we are required to obtain an understanding
+Added: of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s
+Added: internal control over financial reporting.
Accordingly, we express no such opinion.
−Removed: Our audits included performing procedures to assess the risks of material
−Removed: misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks.
−Removed: Such procedures
−Removed: included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
−Removed: Our audits also included
−Removed: evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation
−Removed: of the financial statements.
+Added: Our audits included performing procedures to assess
+Added: the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
+Added: to those risks.
+Added: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
+Added: Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
+Added: the overall presentation of the financial statements.
We believe that our audits provide a reasonable basis for our opinion.
/s/ Wolf & Company, P.C.
+Added: Wolf & Company, P.C.
We have served as the Company's auditor since 2017.
Boston, Massachusetts
−Removed: March 10, 2022
+Added: Mar ch 20, 20 23
Bluejay Diagnostics, Inc.
5 unchanged sentences
Property and equipment, net
+Added: Operating lease right-of-use assets
Other non-current assets
−Removed: LIABILITIES, REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
+Added: LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
−Removed: Due to related party
+Added: Operating lease liability, current
Accrued expenses and other current liabilities
−Removed: Notes payable, net
−Removed: Note payable, Paycheck Protection Program
−Removed: Derivative warrant liability
+Added: Total current liabilities
+Added: Operating lease liability, non-current
+Added: Other non-current liabilities
Total liabilities
Commitments and Contingencies (See Note 13)
−Removed: Series A redeemable, convertible preferred stock, $ 0.0001 par value;
−Removed: 10,600 shares authorized;
−Removed: 0 and 10,600 shares issued and outstanding at December 31, 2021 and 2020, respectively
−Removed: Series B redeemable, convertible preferred stock, $ 0.0001 par value;
−Removed: 5,918 shares authorized;
−Removed: 0 and 5,187 shares issued and outstanding at December 31, 2021 and 2020, respectively
−Removed: Series C redeemable, convertible preferred stock, $ 0.0001 par value;
−Removed: 636 shares authorized;
−Removed: 0 and 636 shares issued and outstanding at December 31, 2021 and 2020, respectively
−Removed: Stockholders’ equity (deficit):
+Added: Stockholders’ equity:
Common stock, $ 0.0001 par value;
5 unchanged sentences
( 7,694,786 )
−Removed: Total stockholders’ equity (deficit)
−Removed: ( 4,206,173 )
−Removed: Total liabilities, redeemable, convertible preferred stocks and stockholders’ equity (deficit)
+Added: Total stockholders’ equity
+Added: Total liabilities and stockholders’ equity
See notes to consolidated financial statements.
−Removed: Reflects a 1-for-3.15 stock dividend effective
−Removed: June 7, 2021.
Bluejay Diagnostics, Inc.
1 unchanged sentence
For the Years Ended
+Added: Cost of sales
Operating expenses:
7 unchanged sentences
Other income (expense):
−Removed: Gain on forgiveness of note payable, Paycheck Protection Program
−Removed: Derivative warrant liability gain (loss)
Interest expense, net of amortization of premium
+Added: Impairment of property and equipment
State grant income
+Added: Other income, net
Total other income (expense), net
5 unchanged sentences
See notes to consolidated financial statements.
−Removed: Reflects a 1-for-3.15 stock dividend effective
−Removed: June 7, 2021.
Bluejay Diagnostics, Inc.
−Removed: of Changes in Redeemable Preferred Stock and Stockholders’ Equity (Deficit)
−Removed: Redeemable, Convertible Preferred Stock
−Removed: Stockholders’ Equity (Deficit)
+Added: Statements of Changes in Redeemable Preferred
+Added: Stock and Stockholders’ Equity (Deficit)
+Added: Convertible Preferred Stock
+Added: Stockholders’
+Added: Equity (Deficit)
Stockholder’s
2 unchanged sentences
$ ( 4,206,173 )
−Removed: Issuance of Series B redeemable, convertible preferred stock, net of issuance costs of $ 4,570
−Removed: Issuance of Series C redeemable, convertible preferred stock, net of issuance costs of $ 8,776
−Removed: Reclassification of derivative warrant liability
−Removed: Accretion of redeemable, convertible preferred stock to redemption value
−Removed: Allocation of proceeds to common stock warrants
−Removed: Stock-based compensation expense
−Removed: ( 1,158,285 )
+Added: Exercise of common stock warrants
+Added: Accretion of redeemable,
+Added: convertible preferred stock to redemption value
+Added: Conversion of convertible
+Added: debentures into Series D preferred stock
+Added: Conversion of redeemable,
+Added: convertible preferred stock into common stock
( 1,151,215 )
−Removed: Balance at December 31, 2020
( 1,834,341 )
( 1,020,426 )
−Removed: Exercise of common stock warrants
−Removed: Accretion of redeemable, convertible preferred stock to redemption value
−Removed: Conversion of convertible debentures into Series D preferred stock
−Removed: Conversion of redeemable, convertible preferred stock into common stock
( 4,036,535 )
+Added: Fair value of warrants issued
+Added: Fair value of warrants issued
+Added: to placement agent in relation to the Convertible debentures
+Added: Conversion of Amended 2017
+Added: Convertible Notes into common stock
+Added: Reclassification of Series
+Added: Stock-based compensation
+Added: Issuance of common stock
+Added: from exercise of stock options
+Added: Issuance of common stock in initial public offering, net of offering costs of $ 2,750,601
+Added: Issuance of common stock
+Added: from exercise of warrants
( 3,488,298 )
( 3,488,298 )
+Added: at December 31, 2021
$ ( 7,694,786 )
−Removed: Fair value of warrants issued for services
−Removed: Fair value of warrants issued to placement agent in relation to the Convertible debentures
−Removed: Conversion of Amended 2017 Convertible Notes into common stock
−Removed: Reclassification of Series B Warrants
−Removed: Stock-based compensation expense
−Removed: Issuance of common stock from exercise of stock options
−Removed: Issuance of common stock in initial public offering, net of offering costs of $ 2,750,601
−Removed: Issuance of common stock from exercise of warrants
+Added: Impact of adoption of ASC 842
+Added: Stock-based compensation
+Added: Exercise of stock options
+Added: Exercise of common stock
+Added: Series B Warrants
( 9,296,948 )
( 9,296,948 )
−Removed: Balance at December 31, 2021
+Added: at December 31, 2022
$ ( 16,997,102 )
See notes to consolidated financial statements.
−Removed: Reflects a 1-for-3.15 stock dividend effective
−Removed: June 7, 2021.
Bluejay Diagnostics, Inc.
2 unchanged sentences
CASH FLOWS FROM OPERATING ACTIVITIES:
+Added: $ ( 9,296,948 )
+Added: $ ( 3,488,298 )
Adjustments to reconcile net loss to net cash used in operating activities:
1 unchanged sentence
Stock-based compensation expense
+Added: Amortization of right-of-use assets
+Added: Impairment of property and equipment
+Added: Loss on disposal of property and equipment
Issuance of warrants for service
1 unchanged sentence
Non-cash interest expense
−Removed: (Gain) loss on revaluation of derivative warrant liability
+Added: Gain on revaluation of derivative warrant liability
Changes in operating assets and liabilities:
−Removed: Accounts receivable
Prepaid expenses and other current assets
+Added: ( 1,551,637 )
Non-current assets
3 unchanged sentences
Net cash used in operating activities
+Added: ( 7,741,593 )
+Added: ( 4,366,758 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment
+Added: ( 1,199,270 )
Net cash used in investing activities
+Added: ( 1,199,270 )
CASH FLOWS FROM FINANCING ACTIVITIES:
3 unchanged sentences
Proceeds from issuance of convertible debentures
−Removed: Proceeds from issuance of Series B redeemable, convertible preferred stock, net of issuance costs
−Removed: Proceeds from issuance of Series C redeemable, convertible preferred stock, net of issuance costs
−Removed: Proceeds from subscription to the 2020 Promissory Notes
−Removed: Proceeds (payments) on note payable, Paycheck Protection Program
+Added: Payments on note payable, Paycheck Protection Program
Proceeds from exercise of common stock warrants
+Added: Payments of deferred offering costs
+Added: Payment of finance lease
Proceeds from exercise of stock options
Net cash provided by financing activities
−Removed: Increase in cash and cash equivalents
+Added: (Decrease) increase in cash and cash equivalents
+Added: ( 8,932,788 )
Cash and cash equivalents, beginning of year
15 unchanged sentences
Fair value of warrants for common stock issued for services
−Removed: Relative fair value of warrants for common stock issued in connection with notes payable
Fair value of warrants issued to underwriters
+Added: Liabilities incurred for the purchase of property and equipment
See notes to consolidated financial statements.
3 unchanged sentences
Bluejay Diagnostics, Inc.
−Removed: (the “Company”),
−Removed: which commenced its activities on March 20, 2015, is incorporated under the laws of the State of Delaware.
−Removed: The Company is a diagnostic company that aims
−Removed: to develop and market a more cost efficient, rapid, near patient product for triage, diagnosis and monitoring of disease progression
−Removed: The Company is utilizing the Symphony
−Removed: technology platform and Symphony IL-6 test licensed from Toray Industries, Inc.
−Removed: of Japan (see Note 3).
−Removed: The Company is also developing
−Removed: biomarkers for detection of other diseases such as hsTNT/I for myocardial injury and NT-proBNP for cardiac heart failure .
−Removed: The Company’s ALLEREYE diagnostic test
−Removed: (“ALLEREYE”) is a POC device that offers healthcare providers a cost effective, reliable, easy to use solution for diagnosis
−Removed: of Allergic Conjunctivitis.
−Removed: ALLEREYE received clearance by the U.S.
−Removed: Food and Drug Administration (the “FDA”) in October 2017.
−Removed: On June 4, 2021, the Company created Bluejay
−Removed: Spinco, LLC, (“SpinCo”) a wholly owned subsidiary of the Company, for purposes of further development of ALLEREYE.
−Removed: transferred assets and liabilities related to ALLEREY to SpinCo in accordance with the Contribution and Assumption Agreement.
−Removed: and liabilities were transferred from the Company to SpinCo at their carrying value.
−Removed: The Company is responsible for the operational activities
−Removed: of SpinCo and bears all costs necessary to operate SpinCo.
−Removed: The Company’s CEO is also the CEO of SpinCo and oversees the business
−Removed: strategy and operations of SpinCo.
+Added: and/or the “Company”) is a medical diagnostics company developing rapid tests using whole blood on our Symphony technology
+Added: platform (“Symphony”) to improve patient outcomes in critical care settings.
+Added: The Company’s Symphony platform is a combination
+Added: of Bluejay’s intellectual property (“IP”) and exclusively licensed and patented IP that consists of a mobile device
+Added: and single-use test cartridges that if cleared, authorized, or approved by the U.S.
+Added: Food and Drug Administration (the “FDA”),
+Added: can provide a solution to a significant market need in the United States.
+Added: Clinical trials indicate the Symphony device produces laboratory-quality
+Added: results in less than 20 minutes in critical care settings, including Intensive Care Units (“ICUs”) and Emergency Rooms (“ERs”),
+Added: where rapid and reliable results are required.
+Added: Bluejay’s first product, the Symphony IL-6
+Added: test, is for the monitoring of disease progression in critical care settings.
+Added: IL-6 is a clinically established inflammatory biomarker,
+Added: considered a ‘first-responder,’ for assessment of severity of infection and inflammation across many disease indications,
+Added: including sepsis.
+Added: A current challenge of healthcare professionals is the excessive time and cost associated determining a patient’s
+Added: level of severity at triage and the Symphony IL-6 test has the ability to consistently monitor this critical care biomarker with rapid
+Added: In the future Bluejay plans to develop additional
+Added: tests for Symphony including two cardiac biomarkers (hsTNT and NT pro-BNP) as well as other tests using the Symphony platform.
+Added: does not yet have regulatory clearance for its Symphony products, and its Symphony products will need to receive regulatory authorization
+Added: from the FDA in order to be marketed as a diagnostic product in the United States.
+Added: Bluejay’s operations to date have been funded
+Added: primarily through the proceeds of the Company’s initial public offering (the “IPO”) in November 2021 (the “IPO
+Added: On June 4, 2021, the Company formed Bluejay Spinco, LLC, a wholly-owned
+Added: subsidiary of the Company, for purposes of further development of the Company’s ALLEREYE diagnostic test.
+Added: ALLEREYE is a point-of-care
+Added: device offering healthcare providers a solution for diagnosing Allergic Conjunctivitis.
Initial Public Offering
−Removed: The Company completed its initial public offering (“IPO”)
−Removed: on November 10, 2021 (“IPO Date”), whereby it sold 2,160,000 Units, each Unit consisting of one share of the Company’s
−Removed: common stock, one warrant to purchase one share of common stock at an exercise price of $7.00 per share (“Class A Warrant”),
−Removed: and one warrant to purchase one share of common stock at an exercise price of $10.00 (“Class B Warrant”) (collectively, a
−Removed: Each Unit was sold at a price of $10.00.
−Removed: Each warrant contained within the Units is exercisable until the fifth anniversary
−Removed: of the IPO date, however, holders of Class B Warrants may exercise such warrants on a “cashless” basis after the earlier of
−Removed: (i) 10 trading days from closing date of the offering or (ii) the time when $10.0 million of volume is traded in our common stock, if
−Removed: the volume weighted average price of the Company’s common stock on any trading day on or after the closing date of the offering
−Removed: fails to exceed the exercise price of the Class B Warrant (subject to adjustment as described in the warrant agreement).
−Removed: Additionally,
−Removed: the underwriter of the IPO exercised their overallotment option, solely with respect to the Class A Warrants and Class B Warrants, shortly
−Removed: after the IPO date resulting in an additional issuance of 324,000 Class A Warrants and 324,000 Class B Warrants.
−Removed: The gross proceeds from
−Removed: the IPO were approximately $ 21.6 million and were offset by $ 2.8 million in offering costs.
+Added: The Company completed its initial public
+Added: offering (the “IPO”) in November 2021 (“IPO Date”), whereby it sold 2,160,000 Units at a price of $10.00, with
+Added: each Unit consisting of one share of the Company’s common stock, one warrant to purchase one share of common stock at an exercise
+Added: price of $7.00 per share (“Class A Warrant”), and one warrant to purchase one share of common stock at an exercise price of
+Added: $10.00 (“Class B Warrant”) (collectively, a “Unit”).
+Added: Each warrant contained within the Units is exercisable until
+Added: the fifth anniversary of the IPO Date, however, holders of Class B Warrants may exercise such warrants on a “cashless” basis
+Added: after the earlier of (i) 10 trading days from closing date of the offering or (ii) the time when $10.0 million of volume is traded in
+Added: the Company’s common stock, if the volume weighted average price of the Company’s common stock on any trading day on or after
+Added: the closing date of the offering fails to exceed the exercise price of the Class B Warrant (subject to adjustment as described in the
+Added: warrant agreement).
+Added: Additionally, the underwriter of the IPO exercised their overallotment option, solely with respect to the Class A
+Added: Warrants and Class B Warrants, shortly after the IPO Date which resulted in an additional issuance of 324,000 Class A Warrants and 324,000
+Added: Class B Warrants.
+Added: The gross proceeds from the IPO were approximately $21.6 million and were offset by $2.8 million in offering costs.
Risks and Uncertainties
−Removed: The Company is subject to a number of risks similar to other companies
−Removed: in its industries, including rapid technological change, competition from larger biotechnology companies and dependence on key personnel.
−Removed: The extent of the impact of the COVID-19 pandemic on the Company’s
−Removed: business continues to be highly uncertain and difficult to predict, as the responses that the Company, other businesses and governments
−Removed: are taking continue to evolve.
−Removed: Furthermore, capital markets and economies worldwide have also been negatively impacted by the COVID-19
−Removed: pandemic, and it is possible that it could cause a lasting national and/or global economic recession.
−Removed: Policymakers around the globe have
−Removed: responded with fiscal policy actions to support the healthcare industry and economy as a whole.
−Removed: The extent to which the COVID-19 pandemic
−Removed: may in the future materially impact the Company’s financial condition, liquidity or results of operations is uncertain.
−Removed: Since its inception, the Company has
−Removed: devoted substantially all of its efforts to business planning, business development, research and development, and raising capital.
−Removed: income potential of the Company’s business and market are unproven.
−Removed: Successful transition to attaining profitable operations is
−Removed: dependent upon achieving a level of revenues adequate to support the Company’s cost structure.
−Removed: As of December 31, 2021, the Company
−Removed: had $ 19.0 million in cash and cash equivalents.
−Removed: The Company believes it has sufficient
−Removed: cash to meet its funding requirements for at least the next 12 months from the issuance of this report.
−Removed: However, the Company has experienced
−Removed: net losses and negative cash flows from operating activities since its inception and has an accumulated deficit of $ 7.7 million as of
−Removed: December 31, 2021.
−Removed: The Company expects to continue to incur net losses for the foreseeable future and believes it will need to raise substantial
−Removed: additional capital to accomplish its business plan over the next several years.
−Removed: The Company plans to continue to fund its losses from
−Removed: operations and capital funding needs through a combination of equity offerings, debt financings and generating revenue from sales to customers.
−Removed: If the Company is not able to secure adequate additional funding or generate sufficient revenue, the Company may be forced to make reductions
−Removed: in spending, extend payment terms with suppliers, liquidate assets where possible, or suspend or curtail planned programs.
−Removed: actions could materially harm the Company’s business, results of operations and future prospects.
−Removed: There can be no assurance as to
−Removed: the availability or terms upon which such financing and capital might be available in the future.
+Added: The Company is subject to a number of risks similar
+Added: to other companies in its industry, including rapid technological change, competition from larger biotechnology companies and dependence
+Added: on key personnel.
+Added: The Company is also impacted by inflationary pressures and global supply chain disruptions currently impacting many
+Added: On October 25, 2022,
+Added: the Company received a notification letter from the Nasdaq Listing Qualifications Staff of The Nasdaq Stock Market LLC (“Nasdaq”)
+Added: notifying the Company that the closing bid price for its common stock had been below $ 1.00 for the previous 30 consecutive business days
+Added: and that the Company therefore is not in compliance with the minimum bid price requirement for continued inclusion on the Nasdaq Capital
+Added: Market under Nasdaq Listing Rule 5550(a)(2).
+Added: The notification has no immediate effect on the listing of the Company’s common stock
+Added: on the Nasdaq Capital Market.
+Added: The Company intends to take all reasonable measures available to achieve compliance and allow for continued
+Added: listing on the Nasdaq Capital Market.
+Added: However, there can be no assurance that the Company will be able to regain compliance with the minimum
+Added: bid price requirement or will otherwise be in compliance with other Nasdaq listing criteria.
+Added: Going Concern
+Added: The Consolidated Financial Statements for the
+Added: years ended December 31, 2022 and 2021 were prepared under the assumption that the Company will continue as a going concern, which contemplates
+Added: that the Company will be able to realize assets and discharge liabilities in the normal course of business.
+Added: However, the Company has incurred
+Added: net losses since its inception, and has negative cash flows from operations and will need additional funding to complete planned development
+Added: These conditions raise substantial doubt about the Company’s ability to continue as a going concern.
+Added: The Company had cash and cash equivalents of $ 10.1 million at December
+Added: It continues to develop the Symphony device and its first test for the measurement of IL-6.
+Added: It remains committed to obtaining
+Added: FDA clearance and has expanded clinical trials to obtain additional data to support its de novo FDA submission, while also continuing
+Added: to build its manufacturing operations with its CMOs.
+Added: Current cash resources and expected operating expenses are considered in determining
+Added: its liquidity requirement;
+Added: as well as $ 1.6 million of current liabilities on its balance sheet at December 31, 2022 and capital commitments
+Added: of approximately $ 2 million during 2023 (see Notes 12 and 13).
+Added: Given the Company’s current plans, the Company estimates cash resources
+Added: will be sufficient to fund its operations through the fourth quarter of 2023.
+Added: The Company will need additional capital to fund its planned
+Added: operations for the next 12 months.
+Added: The Company may seek to raise such additional
+Added: capital through public or private equity offerings, grant financing and support from governmental agencies, convertible debt, collaborations,
+Added: strategic alliances and distribution arrangements.
+Added: Additional funds may not be available when it needs them on terms that are acceptable
+Added: to them, or at all.
+Added: If adequate funds are not available, it may be required to delay or reduce the scope of its research or development
+Added: programs, its commercialization efforts or its manufacturing commitments and capacity.
+Added: In addition, if it raises additional funds through
+Added: collaborations, strategic alliances or distribution arrangements with third parties, it may have to relinquish valuable rights to its
+Added: technologies or future revenue streams.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
2 unchanged sentences
have been prepared in accordance with U.S.
−Removed: generally accepted accounting principles (GAAP) and include all adjustments necessary for
−Removed: the presentation of the Company’s consolidated financial position, results of operations and cash flows for the periods presented.
+Added: generally accepted accounting principles in the United States (“GAAP”) and include
+Added: all adjustments necessary for the presentation of the Company’s consolidated financial position, results of operations and cash
+Added: flows for the periods presented.
The consolidated financial statements include the accounts of the Company and its wholly owned subsidiary.
−Removed: All intercompany balances
−Removed: and transactions have been eliminated in consolidation.
−Removed: On June 7, 2021, the Company’s
−Removed: Board of Directors declared a stock dividend of 2.15 shares of common stock for every share of common stock.
−Removed: This stock dividend was
−Removed: deemed a large stock dividend and was treated as a 1-for-3.15 stock split (“Stock Split”).
−Removed: The common stock shares and per
−Removed: share amounts (other than authorized shares) in these consolidated financial statements and related notes have been retroactively restated
−Removed: to reflect the stock dividend for all periods presented.
+Added: All intercompany balances and transactions have been eliminated in consolidation.
+Added: On June 7, 2021, the Company’s Board
+Added: of Directors declared a stock dividend of 2.15 shares of common stock for every share of common stock.
+Added: This stock dividend was deemed
+Added: a large stock dividend and was treated as a 1-for-3.15 stock split.
+Added: The common stock shares and per share amounts (other than authorized
+Added: shares) in these consolidated financial statements and related notes have been retroactively restated to reflect the stock dividend for
+Added: all periods presented.
Use of Estimates
The preparation of financial statements in conformity
−Removed: with GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in these consolidated
+Added: with GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in these condensed consolidated
financial statements and accompanying notes.
3 unchanged sentences
The Company evaluates its estimates and assumptions as facts and circumstances dictate.
−Removed: As future events and their effects cannot be
−Removed: determined with precision, actual results could differ from these estimates and assumptions, and those differences could be material
−Removed: to the consolidated financial statements.
+Added: As future events and their effects cannot be determined
+Added: with precision, actual results could differ from these estimates and assumptions, and those differences could be material to the condensed
+Added: consolidated financial statements.
+Added: Financial Statement Reclassifications
+Added: Certain balances in the prior year consolidated
+Added: financial statements have been reclassified to conform to the presentation in the current year consolidated financial statements.
Cash and Cash Equivalents
1 unchanged sentence
with maturities of three months or less at the date of purchase to be cash equivalents.
−Removed: The Company maintains its cash in bank deposit
−Removed: accounts which, at times, may exceed the federal insurance limit.
+Added: Cash equivalents, consisting of highly liquid
+Added: money market are carried at fair market value which approximates cost.
+Added: Revenue Recognition
+Added: The Company recognizes revenue under the core
+Added: principles of depicting the transfer of control to the Company’s customers in an amount reflecting the consideration to which the
+Added: Company expected to be entitled.
+Added: In order to achieve that core principle, the Company applies the following five step approach:
+Added: the contract with a customer, (2) identify the performance obligations in that contract, (3) determine the transaction price, (4) allocate
+Added: the transaction price to the performance obligations in the contract, and (5) recognize revenue when a performance obligation is satisfied.
+Added: The Company recognizes revenue when performance
+Added: obligations under the terms of the contract with the customer are satisfied and are recognized at a point in time, which is also when
+Added: control is transferred.
+Added: When the Company performs shipping and handling activities after the transfer of control to the customer (e.g.
+Added: when control transfers prior to delivery), they are considered fulfillment activities and, accordingly, the costs are accrued for when
+Added: the related revenue is recognized.
+Added: Sales tax and valued added taxes collected from the customers relating to product sales and remitted
+Added: to governmental authorities are excluded from revenues.
+Added: Effective January 1, 2022, the Company adopted
+Added: the Financial Accounting Standards Board’s (“FASB”) Accounting Standards Codification (“ASC”) ASC 842, Leases
+Added: The Company has adopted ASC 842 using the optional transition method and, as a result, there have been no reclassification
+Added: of prior comparable periods due to this adoption.
+Added: The Company has arrangements involving the lease
+Added: of facilities.
+Added: Under ASC 842, at inception of the arrangement, the Company determines whether the contract is or contains a lease and
+Added: whether the lease should be classified as an operating or a financing lease.
+Added: This determination, among other considerations, involves
+Added: an assessment of whether the Company can control the underlying asset and have the right to obtain substantially all to the economic benefits
+Added: or outputs from the asset.
+Added: The Company recognizes right-of-use (“ROU”)
+Added: assets and lease liabilities as of the lease commencement date based on the net present value of the future minimum lease payments over
+Added: the lease term.
+Added: ASC 842 requires the leases to use the rate implicit in the lease unless it is not readily determinable and then it may
+Added: use its incremental borrowing rate (“IBR”) to discount the future minimum lease payments.
+Added: Most of the Company’s leases
+Added: do not provide an implicit rate;
+Added: therefore, the Company uses its IBR to discount the future minimum lease payments.
+Added: The Company determines
+Added: its IBR with its credit rating and other economic information available as of the commencement date, as well as the identified lease term.
+Added: During the assessment of the lease term, the Company considers its renewal options and extensions within the arrangements and the Company
+Added: includes these options when it’s reasonably certain to extend the term of the lease.
+Added: The Company leases include both lease and non-lease
+Added: Consideration is allocated to the lease and non-lease components based on estimated standalone prices.
+Added: The Company has elected
+Added: to exclude non-lease components from the calculation of its ROU assets and lease liabilities.
+Added: The Company has lease arrangements that contain
+Added: incentives for tenant improvements as well as fixed rent escalation clauses.
+Added: For contracts with tenant improvement incentives that are
+Added: determined to be leasehold improvements and the Company is reasonably certain to exercise, it records a reduction to the lease liability
+Added: and amortizes the incentive over the identified term of the lease as a reduction to rent expense.
+Added: The Company records rental expense on
+Added: a straight-line basis over the identified lease term on contracts with rent escalation clauses.
+Added: Finance leases are not material to the Company’s
+Added: consolidated financial statements.
Concentration of Credit Risk
5 unchanged sentences
Research and Development Expenses
−Removed: Development costs incurred in the research and
−Removed: development of new products are expensed as incurred.
−Removed: Research and development costs include, but are not limited to, salaries, benefits,
−Removed: stock-based compensation, laboratory supplies, fees for professional service providers and costs associated with product development efforts,
−Removed: including preclinical studies and clinical trials.
+Added: Costs incurred in the research and development
+Added: of new products are expensed as incurred.
+Added: Research and development costs include, but are not limited to, salaries, benefits, stock-based
+Added: compensation, laboratory supplies, fees for professional service providers and costs associated with product development efforts, including
+Added: preclinical studies and clinical trials.
+Added: As of December 31, 2022 and 2021, respectively, the Company had $ 371,000 and $ 0 capitalized in
+Added: property and equipment related to pre-production molds and tooling related to the Symphony device.
The Company estimates preclinical study and clinical
−Removed: trial expenses based on the services performed, pursuant to contracts with research institutions and clinical research organizations
−Removed: that conduct and manage preclinical studies and clinical trials on its behalf.
−Removed: In accruing service fees, the Company estimates the time
−Removed: period over which services will be performed and the level of effort to be expended in each period.
−Removed: If the actual timing of the performance
−Removed: of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly.
−Removed: Payments made to third
−Removed: parties under these arrangements in advance of the receipt of the related services are recorded as prepaid expenses until the services
−Removed: are rendered.
−Removed: Derivative instruments
−Removed: The Company does not use derivative
−Removed: instruments to hedge exposures to cash flow or market risks;
−Removed: however, certain warrants to purchase preferred stock that do not meet the
−Removed: requirements for classification as equity are classified as liabilities.
−Removed: In such instances, net-cash settlement is assumed for financial
−Removed: reporting purposes, even when the terms of the underlying contracts do not provide for a net -cash settlement.
−Removed: Such financial instruments
−Removed: are initially recorded at fair value with subsequent changes in value charged (credited) to operations each reporting period.
−Removed: instruments subsequently meet the requirements for classification as equity, the Company reclassifies the then fair value to equity.
−Removed: The Company values its outstanding warrants using the Black-Scholes
−Removed: option pricing model.
+Added: trial expenses based on the services performed, pursuant to contracts with research institutions and clinical research organizations that
+Added: conduct and manage preclinical studies and clinical trials on its behalf.
+Added: In accruing service fees, the Company estimates the time period
+Added: over which services will be performed and the level of effort to be expended in each period.
+Added: If the actual timing of the performance of
+Added: services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly.
+Added: Payments made to third parties
+Added: under these arrangements in advance of the receipt of the related services are recorded as prepaid expenses until the services are rendered.
Stock-Based Compensation
−Removed: Share-based compensation expense for
−Removed: all share-based payment awards made to employees, directors and non-employees is measured based on the grant-date fair value of the award.
+Added: Share-based compensation expense for all
+Added: share-based payment awards made to employees, directors and non-employees is measured based on the grant-date fair value of the award.
Share-based compensation expense for awards granted to non-employees is determined using the fair value of the consideration received
14 unchanged sentences
based on the simplified method for grants to employees and is based on the contractual term for non-employee awards.
−Removed: The risk-free
−Removed: interest rate assumption is based on observed interest rates appropriate for the terms of the awards.
−Removed: The dividend yield assumption is
−Removed: based on history and expectation of paying no dividends.
+Added: The risk-free interest
+Added: rate assumption is based on observed interest rates appropriate for the terms of the awards.
+Added: The dividend yield assumption is based on
+Added: history and expectation of paying no dividends.
The Company recognizes forfeitures related to
employee share-based payments when they occur.
−Removed: Forfeited options are recorded as a reduction to stock compensation expense.
−Removed: Fair Value Measurements
−Removed: The Company applies a three-level valuation hierarchy
−Removed: for fair value measurements.
−Removed: The categorization of assets and liabilities within the valuation hierarchy is based on the lowest level
−Removed: of input that is significant to the measurement of fair value.
−Removed: inputs to the
−Removed: valuation methodology utilize unadjusted quoted market prices in active markets for identical assets and liabilities.
−Removed: inputs to the valuation
−Removed: methodology are other observable inputs, including quoted market prices for similar assets and liabilities, quoted prices for identical
−Removed: and similar assets and liabilities in markets that are not active, or other inputs that are observable or can be corroborated by
−Removed: observable market data.
−Removed: inputs to the valuation
−Removed: methodology are unobservable inputs based on management’s best estimate of the inputs that market participants would use in
−Removed: pricing the asset or liability at the measurement date, including assumptions about risk.
−Removed: A change to the level of an
−Removed: asset or liability within the fair value hierarchy is determined at the end of a reporting period.
−Removed: Fair Values of Financial Instruments
−Removed: The fair value of cash, cash equivalent, and accounts
−Removed: payable approximates the carrying value of these financial instruments because of the short-term nature of any maturities.
−Removed: determines the estimated fair values of other financial instruments, using available market information and valuation methodologies, primarily
−Removed: input from independent third-party pricing sources.
−Removed: Redeemable Convertible Preferred
−Removed: The Company has classified Series A, Series B,
−Removed: and Series C redeemable, convertible preferred stock (“Preferred Stock”) as temporary equity in the accompanying consolidated
−Removed: balance sheet at December 31, 2020 due to terms that allow for redemption of the shares upon certain events that are outside of the Company’s
−Removed: On June 1, 2021, the Company’s outstanding Preferred Stock was converted into common stock (see Note 8).
+Added: Forfeited share-based awards are recorded as a reduction to stock compensation expense.
Segment Reporting
1 unchanged sentence
one operating segment, which is consistent with the Company structure and how it manages the business.
−Removed: As of December 31, 2021 and 2020,
−Removed: all of the Company’s assets were located in the United States.
The Company follows accounting guidance regarding
8 unchanged sentences
Any interest or penalties are charged to expense.
−Removed: During the years ended
−Removed: December 31, 2021 and 2020, the Company did not recognize any interest and penalties.
−Removed: Tax years subsequent to December 31, 2017 are subject
−Removed: to examination by federal and state authorities.
+Added: During the years ended December
+Added: 31, 2022 and 2021, the Company had no significant interest and penalties.
+Added: Tax years subsequent to December 31, 2018 are subject to examination
+Added: by federal and state authorities.
The Company recognizes deferred tax assets and
12 unchanged sentences
stock and dilutive common stock equivalents outstanding for the period determined using the treasury stock and if-converted methods.
−Removed: Dilutive common stock equivalents are comprised of convertible preferred stock, convertible notes, options outstanding under the Company’s
+Added: common stock equivalents are comprised of convertible preferred stock, convertible notes, options outstanding under the Company’s
stock option plan and warrants.
3 unchanged sentences
included in the calculation of diluted net loss per share because to do so would be anti-dilutive are as follows (in common stock equivalent
−Removed: Redeemable, convertible preferred stock
Options to purchase common stock
Warrants for common stock
−Removed: Warrants for Series B redeemable, convertible preferred stock
Class A Warrants for common stock
Class B Warrants for common stock
−Removed: Newly Adopted Accounting Standards
−Removed: In August 2020, the FASB issued ASU
−Removed: 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s
−Removed: Own Equity (Subtopic 815-40) Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity .
−Removed: This guidance changes
−Removed: how entities account for convertible instruments and contracts in an entity’s own equity and simplifies the accounting for convertible
−Removed: instruments by removing certain separation models for convertible instruments.
−Removed: This guidance also modifies the guidance on diluted earnings
−Removed: per share calculations.
−Removed: This new guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after
−Removed: December 15, 2023.
−Removed: Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim
−Removed: periods within those fiscal years.
−Removed: The Company elected to early adopt this guidance in the first quarter of 2021.
−Removed: The adoption of this
−Removed: standard had no material impact on the Company’s consolidated financial statements.
−Removed: Recently Issued Accounting Standards
−Removed: In May 2021, the FASB issued ASU 2021-04 Earnings
−Removed: Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718),
−Removed: and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40):
−Removed: Issuer’s Accounting for Certain Modifications
−Removed: or Exchanges of Freestanding Equity-Classified Written Call Options (a consensus of the FASB Emerging Issues Task Force) .
−Removed: The amendments
−Removed: in this update are effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within
−Removed: those fiscal years.
−Removed: Early application is permitted, including in an interim period as of the beginning of the fiscal year that includes
−Removed: that interim period.
−Removed: The Company is currently evaluating the adoption date of this ASU and the impact, if any, adoption will have on its
+Added: Recently Adopted Accounting Standards
+Added: In February 2016, the FASB issued Accounting Standards
+Added: Update (“ASU”) 2016-02, Leases.
+Added: The new guidance requires the recognition of lease liabilities, representing future
+Added: minimum lease payments, on a discounted basis, and corresponding right-of-use assets on a balance sheet for most leases, along with requirements
+Added: for enhanced disclosures to give financial statement users the ability to assess the amount, timing, and uncertainty of cash flows arising
+Added: from leasing arrangements.
+Added: The Company adopted the provisions of ASU 2016-02 on January 1, 2022 and elected to implement the transition
+Added: package of practical expedients permitted within the new standard, which included (i) not reassessing whether expired or existing contract
+Added: contain leases, (ii) not reassessing lease classification, and (iii) not revaluing initial direct costs for existing leases.
+Added: of the new standard resulted in the recording of initial right-of-use assets and lease liabilities of approximately $ 200,000 as of January
+Added: The new standard did not materially impact the Company’s consolidated statements of operations or cash flows.
+Added: In May 2021, the FASB issued ASU
+Added: 2021-04 Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock
+Added: Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40):
+Added: Issuer’s Accounting
+Added: for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (a consensus of the FASB Emerging Issues
+Added: Task Force) .
+Added: The amendments in this update are effective for all entities for fiscal years beginning after December 15, 2021,
+Added: including interim periods within those fiscal years.
+Added: Early application is permitted, including in an interim period as of the beginning
+Added: of the fiscal year that includes that interim period.
+Added: The adoption date of this ASU did not have a material impact on the Company’s
financial position and results of operations.
−Removed: February 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-02 , Leases.
−Removed: new guidance requires the recognition of lease liabilities, representing future minimum lease payments, on a discounted basis, and corresponding
−Removed: right-of-use assets on a balance sheet for most leases, along with requirements for enhanced disclosures to give financial statement users
−Removed: the ability to assess the amount, timing, and uncertainty of cash flows arising from leasing arrangements.
−Removed: The Company adopted the provisions
−Removed: of ASU 2016-02 on January 1, 2022 and elected to implement the transition package of practical expedients permitted within the new standard,
−Removed: which included (i) not reassessing whether expired or existing contract contain leases, (ii) not reassessing lease classification, and
−Removed: (iii) not revaluing initial direct costs for existing leases.
−Removed: Adoption of the new standard resulted in the recording of initial right-of-use
−Removed: assets and lease liabilities of approximately $ 200,000 as of January 1, 2022.
−Removed: The new standard did not materially impact the Company’s
−Removed: consolidated statements of operations or cash flows.
+Added: Recently Issued Accounting Standards
+Added: In October 2021, the FASB issued ASU No.
+Added: Business Combinations (Topic 805):
+Added: Accounting for Contract Assets and Contract Liabilities from Contracts with Customers (“ASU
+Added: 805”) , an amendment of the ASC.
+Added: The amendments to ASU 805 address diversity and inconsistency related to the recognition and
+Added: measurement of contract assets and contract liabilities acquired in a business combination and require that an acquirer recognize and
+Added: measure contract assets and contract liabilities acquired in accordance with ASC 2014-09, Revenue from Contracts with Customers (Topic
+Added: 606) (“ ASC 606”).
+Added: Under GAAP, an acquirer generally recognizes assets and liabilities assumed in a business combination,
+Added: including contract assets and liabilities arising from revenue contracts with customers, at fair value on the acquisition date.
+Added: 2021-08 will result in the acquirer recording acquired contract assets and liabilities on the same basis that would have been recorded
+Added: by the acquiree before the acquisition under ASC 606.
+Added: This ASU is effective for fiscal years beginning after December 15, 2022, with early
+Added: adoption permitted, including adoption in an interim period.
+Added: The Company is currently evaluating the effect that this standard may have
+Added: on its financial position and related disclosures.
LICENSE AND SUPPLY AGREEMENT WITH TORAY INDUSTRIES
On October 6, 2020, the Company entered
−Removed: into a license and supply agreement (“Toray Agreement”) with Toray Industries, Inc.
−Removed: Under the Toray
−Removed: Agreement, the Company received the exclusive license to make and distribute the protein detection chips that has a function of automatic
−Removed: stepwise feeding of reagent (“Toray Chips”) outside of Japan.
−Removed: In exchange for the license, the Company committed to make two
−Removed: payments of $ 120,000 each.
−Removed: The first payment was made in January 2021, and the second payment was made in October 2021.
−Removed: In addition, following
−Removed: the first sale of Toray Chips, the Company will also make royalty payments to Toray equal to 15 % of the net sales of the Toray Chips for
−Removed: the period that any underlying patents exist or for 5 years after the first sale.
−Removed: Following the first sale, the Company will pay a one-time
−Removed: minimum royalty of $ 60,000 , which shall be creditable against any royalties owed to Toray in such calendar year.
−Removed: The Company will pay
−Removed: a minimum royalty of $ 100,000 in each year thereafter, which are creditable against any royalties owed to Toray in such calendar year.
−Removed: There were no sales of or revenues from the Toray Chips during the twelve-month periods ended December 31, 2021 and 2020.
−Removed: At December 31, 2020, $ 240,000 were
−Removed: accrued related to the Toray Agreement and was included in current liabilities on the consolidated balance sheet.
−Removed: No amounts were accrued
−Removed: at December 31, 2021.
−Removed: FAIR VALUE MEASUREMENTS
−Removed: The assets and liabilities measured at fair value on a recurring basis
−Removed: at December 31, 2021 and 2021 are summarized in the tables below.
−Removed: Cash equivalents - money market funds
−Removed: Derivative warrant liability
−Removed: The table below presents the changes
−Removed: in Level 3 liabilities measured at fair value on a recurring basis.
−Removed: Balance at December 31, 2019
−Removed: Unrealized loss
−Removed: Issuance of Series B warrants
−Removed: Balance at December 31, 2020
−Removed: Unrealized gain
−Removed: Fair value of Series B warrants converted into warrants for common stock
−Removed: Balance at December 31, 2021
−Removed: Unrealized gain (loss) on revaluation
−Removed: of derivative warrant liability is included in derivative warrant liability gain (loss) in the consolidated statements of operations.
−Removed: There were no assets or liabilities
−Removed: measured at fair value on a non-recurring basis at December 31, 2021 or 2020.
+Added: into a License and Supply Agreement (“License Agreement”) with Toray Industries, Inc.
+Added: Under the License
+Added: Agreement, the Company received the exclusive license (outside of Japan) to make and distribute protein detection cartridges that have
+Added: a function of automatic stepwise feeding of reagent (the “Cartridges”).
+Added: In exchange for the license, the Company committed
+Added: to make two payments of $ 120,000 each, both of which were made in 2021.
+Added: In addition, following the first sale of the Cartridges after
+Added: regulatory approval, the Company will make royalty payments to Toray equal to 15 % of the net sales of the Cartridges for the period that
+Added: any underlying patents exist or five years after the first sale.
+Added: Following the first sale after obtaining regulatory approval, the Company
+Added: will make minimum annual royalty payments of $ 60,000 for the first year and $ 100,000 for each year thereafter, which shall be creditable
+Added: against any royalties owed to Toray in such calendar year.
+Added: There were no sales of or revenues from the Cartridges during the 12-month
+Added: periods ended December 31, 2022 and 2021.
+Added: At December 31, 2022 and 2021, there
+Added: were no amounts accrued related to the License Agreement.
NOTES PAYABLE
1 unchanged sentence
In 2017, the Company entered into multiple
−Removed: Unit Purchase Agreements.
−Removed: In connection with this financing (the “Financing”), the Company issued 106 Units at a purchase
−Removed: price of $ 20,000 each.
−Removed: A Unit consisted of 100 shares of Series A redeemable, convertible preferred stock (“Series A”) at
−Removed: a purchase price of $ 100 per share (“Original Offering Price”) and $ 10,000 in notes payable (the “Notes”).
−Removed: proceeds from the Financing were $ 2,120,000 and were allocated between the Notes and Series A based on their relative fair values with
−Removed: $ 1,643,349 allocated to the Notes and $ 476,651 to the Series A.
−Removed: The Notes are secured by all business assets of the Company and are fully
−Removed: guaranteed by Lana Management and Business Research International, LLC (“LMBRI”), a related party (see Note 10).
−Removed: Certain Notes with aggregate principal
−Removed: amount of $ 930,000 mature on March 20, 2022 while $ 130,000 of the Notes mature on June 22, 2022.
−Removed: The Notes bear interest at 5 % per annum,
−Removed: increasing to 7 % on the amounts in default.
−Removed: For the first twelve months following issuance of the Notes, interest accrued on the Notes
−Removed: of approximately $ 53,000 was added to the principal balance of the Notes and not paid out to investors.
−Removed: The Notes require principal payments
−Removed: of $ 265,000 per year commencing in 2019 on the second anniversary of the Notes’ issuance and annually thereafter, until the final
−Removed: principal payment upon maturity.
−Removed: For the year ended December 31, 2020, no principal payments were made to investors and the remaining
−Removed: unpaid balance on the Notes became immediately due and was classified as short-term at December 31, 2020.
−Removed: The Company defaulted on the
−Removed: Notes in January 2021.
+Added: Unit Purchase Agreements (the “Financing”) whereby the Company issued 106 Units.
+Added: Each Unit consisted of 100 shares of Series
+Added: A redeemable, convertible preferred stock (“Series A”) at a purchase price of $100 per share and $10,000 in notes payable
+Added: (the “Notes”).
+Added: The Company defaulted on certain Notes issued in 2017 with aggregate principal amount of $ 1,060,000 in January
On February 17, 2021, the Company repaid in cash $ 268,000 in principal and $ 2,010 in accrued interest on the Notes.
−Removed: On May 26, 2021, the remaining Notes of $ 580,000 were amended and restated (the “Amended Notes”).
−Removed: The Amended Notes accrue
−Removed: no interest and are due in May 2023.
−Removed: On June 8, 2021, the Amended Notes were automatically convertible into 580,000 shares of common
−Removed: stock at the conversion rate of $ 1.00 per share upon the issuance by the Company of securities to Sabby Volatility Warrant Master Fund,
−Removed: Ltd (“Sabby”) (the “Sabby Agreement”) (see Note 6).
−Removed: The amendment and subsequent conversion of the Notes was
−Removed: accounted for as the debt settlement in equity under ASC 470-60 Troubled Debt Restructurings by Debtors .
−Removed: The Company recognized
−Removed: a gain on extinguishment of $ 6,360 , equal to the difference between the carrying amount of the Notes at the conversion date, totaling
−Removed: $ 586,360 , and the fair value of the common stock shares issued to the noteholders of $ 580,000 .
−Removed: This gain on extinguishment is included
−Removed: in other income on the consolidated statement of operations for the year ended December 31, 2021.
−Removed: For the years ended December 31,
−Removed: 2021 and 2020 the interest expense on the Notes was $ 6,360 and $ 59,274 , respectively.
+Added: On May 26, 2021,
+Added: the remaining Notes of $ 580,000 were amended and restated (the “Amended Notes”).
+Added: The Amended Notes accrue no interest and
+Added: were due in May 2023.
+Added: On June 8, 2021, the Amended Notes were automatically convertible into 580,000 shares of common stock at the conversion
+Added: rate of $ 1.00 per share upon the issuance by the Company of securities to Sabby Volatility Warrant Master Fund, Ltd (“Sabby”)
+Added: (the “Sabby Agreement”).
+Added: The amendment and subsequent conversion of the Notes was accounted for as the debt settlement in
+Added: equity under ASC 470-60 Troubled Debt Restructurings by Debtors .
+Added: The Company recognized a gain on extinguishment of $ 6,360 , equal
+Added: to the difference between the carrying amount of the Amended Notes at the conversion date, totaling $ 586,360 , and the fair value of the
+Added: common stock shares issued to the noteholders of $ 580,000 .
+Added: This gain on extinguishment is included in other income on the consolidated
+Added: statement of operations for the year ended December 31, 2021.
+Added: For the year ended December 31, 2021 the interest expense on the Notes was
The allocation of the gross proceeds
4 unchanged sentences
The Company recognized the amortization
−Removed: of the premium of $ 145,837 and $ 116,670 as a reduction to non-cash interest expense during the years ended December 31, 2021 and 2020,
−Removed: respectively.
−Removed: The premium amortization was included within interest income (expense) on the consolidated statements of operations.
−Removed: In connection with the Financing,
−Removed: the Company paid $ 183,194 in issuance costs of which $ 91,597 was recorded as a discount on the Notes and is being amortized over the
−Removed: term of the Notes.
+Added: of the premium of $ 145,837 as a reduction to non-cash interest expense during the year ended December 31, 2021.
+Added: The premium amortization
+Added: was included within interest income (expense) on the consolidated statements of operations.
+Added: In connection with the Financing, the
+Added: Company paid $ 183,194 in issuance costs of which $ 91,597 was recorded as a discount on the Notes and is being amortized over the term
+Added: of the Notes.
The remaining $ 91,597 was netted with the proceeds allocated to Series A (see Note 7).
−Removed: The Company recognized the
−Removed: amortization of the discount of $ 22,899 and $ 18,319 as non-cash interest expense during the year ended December 31, 2021 and 2020, respectively.
−Removed: The discount amortization was included in the interest income (expense) on the consolidated statements of operations.
+Added: The Company recognized the amortization
+Added: of the discount of $ 22,899 as non-cash interest expense during the year ended December 31, 2021.
+Added: The discount amortization was included
+Added: in the interest income (expense) on the consolidated statements of operations.
2020 Subordinated Notes
On October 22, 2020, the Company issued
−Removed: in subordinated promissory notes (“Subordinated Notes”) to the Company’s shareholders, including $ 30,000 to LMBRI.
−Removed: The Subordinated Notes accrued interest at 8 % payable at each quarter end and had a maturity date of March 31, 2021.
−Removed: The Company defaulted
−Removed: on the Subordinated Notes on March 31, 2021, and the Subordinated Notes started to accrue 15 % penalty interest starting on the date of
−Removed: For the years ended December 31, 2021 and 2020 interest expense on the Subordinated Notes was $ 7,443 and $ 2,396 respectively.
−Removed: In conjunction with the issuance of the Subordinated
−Removed: Notes, the Company issued to each noteholder warrants to purchase shares of the Company’s common stock (“Subordinated Note
−Removed: Warrants”) totaling 4,846,688 Common Stock Warrants, of which 944,160 were issued to LMBRI.
−Removed: The Subordinated Note Warrants have
−Removed: an exercise price of $ 0.03 per share, and are exercisable upon issuance date and have a 5 -year term.
−Removed: The Subordinated Note Warrants may
−Removed: be exercised for cash or through cancellation of the Subordinated Notes.
−Removed: The terms of the Common Stock Warrants were amended in November
−Removed: 2021 to provide for cashless exercise (see Note 7).
−Removed: The fair value of the Subordinated Note Warrants at the issuance date was estimated
−Removed: to be $ 4,488,570 using a Black-Scholes option pricing model.
−Removed: The Subordinated Note Warrants were accounted
−Removed: for as equity under ASC 815 – Derivatives and Hedging .
−Removed: The proceeds from the issuance of the Subordinated Notes were allocated
−Removed: between the Subordinated Notes and the Subordinated Note Warrants based on their relative fair values, with $ 5,108 allocated to the Subordinated
−Removed: Notes and $ 148,892 allocated to the Common Stock Warrants.
−Removed: The proceeds allocated to the Subordinated Note Warrants were recorded in additional
−Removed: paid-in capital on the accompanying consolidated balance sheet as of December 31, 2020.
−Removed: The allocation of the proceeds to the
−Removed: Subordinated Note Warrants resulted in a discount to the Subordinated Notes of $ 148,892 .
−Removed: The Company amortized this discount through non-cash
−Removed: interest expense using the effective interest method, of which $ 83,752 and $ 65,140 was amortized during the years ended December 31, 2021
−Removed: and 2020, respectively, and included in the interest income (expense) in the consolidated statement of operations.
−Removed: On June 7, 2021, the holders of $ 132,383 in principal of the Subordinated
−Removed: Notes elected to exercise their warrants into 4,166,357 shares of common stock, with the principal from those notes applied to the exercise
−Removed: price of the warrants.
−Removed: The remaining $ 21,617 principal amount of the Subordinated Notes was repaid in cash in 2021.
+Added: $ 154,000 in subordinated promissory notes (“Subordinated Notes”) to the Company’s stockholders, including $ 30,000 to
+Added: Lana Management and Business Research International, LLC (“LMBRI”).
+Added: The Subordinated Notes accrued interest at 8 % payable
+Added: at each quarter end and had a maturity date of March 31, 2021.
+Added: The Company defaulted on the Subordinated Notes on March 31, 2021, and
+Added: the Subordinated Notes started to accrue 15 % penalty interest starting on the date of default.
+Added: For the year ended December 31, 2021 interest
+Added: expense on the Subordinated Notes was $ 7,443 .
+Added: In conjunction with the issuance of the Subordinated Notes, the Company issued to each noteholder
+Added: warrants to purchase shares of the Company’s common stock (“Subordinated Note Warrants”) totaling 4,846,688 Common Stock
+Added: Warrants, of which 944,160 were issued to LMBRI.
+Added: The allocation of the proceeds to the Subordinated Note Warrants resulted in a discount
+Added: to the Subordinated Notes of $ 148,892 .
+Added: The Company amortized this discount through non-cash interest expense using the effective interest
+Added: method, of which $ 83,752 was amortized during the year ended December 31, 2021, and included in the interest income (expense) in the consolidated
+Added: statement of operations.
+Added: On June 7, 2021, the holders of $ 132,383
+Added: in principal of the Subordinated Notes elected to exercise their warrants into 4,166,357 shares of common stock, with the principal from
+Added: the Subordinated Notes applied to the exercise price of the warrants.
+Added: The remaining $ 21,617 principal amount of the Subordinated Notes
+Added: was repaid in cash in 2021.
CONVERTIBLE DEBENTURES
6 unchanged sentences
a total of $ 3,000,000 of 7.5 % Senior Secured Convertible Debentures (the “Convertible Debentures”) to Sabby.
−Removed: 2021, the Company issued an additional $ 1,500,000 of Convertible Debentures upon the filing of a registration statement in an Initial
−Removed: Public Offering, which was filed on July 22, 2021.
−Removed: The Convertible Debentures were due on May 31, 2022 and secured by all of the Company’s
−Removed: assets except for the assets transferred to SpinCo.
+Added: 2021, the Company issued an additional $ 1,500,000 of Convertible Debentures upon the filing of a registration statement in connection
+Added: to the IPO, which was filed on July 22, 2021.
The Convertible Debentures’ principal amount was convertible, at the holder’s
2 unchanged sentences
Debenture was automatically converted into Series D upon the effectiveness of an IPO.
−Removed: The Company was obligated to pay interest on the
−Removed: Convertible Debentures at the rate of 7.5% per annum, payable quarterly beginning on July 1, 2021, on each Conversion Date (as to that
−Removed: principal amount then being converted), on the Forced Conversion Date (as to that principal amount then being converted) and on the Maturity
−Removed: Date in cash.
−Removed: For the year ended December 31, 2021, interest expense on the Convertible Debentures was $ 124,829 .
−Removed: In connection with the IPO, on November
−Removed: 10, 2021, all of the Company’s outstanding Convertible Debentures automatically converted into 4,500 shares of Series D Preferred
−Removed: Subsequently the holder of all the 4,500 outstanding shares of Series D Preferred Stock exercised their option to convert their
−Removed: Series D preferred stock shares into 4,500,000 shares of common stock.
+Added: For the year ended December 31, 2021, interest expense
+Added: on the Convertible Debentures was $ 124,829 .
+Added: In connection with the IPO, all of
+Added: the Company’s outstanding Convertible Debentures automatically converted into 4,500 shares of Series D Preferred Stock on the IPO
+Added: Subsequently, the holder of the 4,500 outstanding shares of Series D Preferred Stock exercised their option to convert their shares
+Added: into 4,500,000 shares of common stock.
The Company incurred $ 729,658 in issuance
−Removed: costs consisting of cash payments and 225,000 warrants (“Dawson Warrants”) issued to the placement agent for compensation
+Added: costs consisting of cash payments and 225,000 warrants (the “Dawson Warrants”) issued to the placement agent for compensation
for their services in relation to the issuance of the Convertible Debentures.
1 unchanged sentence
the exercise price of $ 1.25 per share of common stock and have a 5 -year term.
−Removed: These warrants were accounted for as equity under ASC 815
+Added: The Dawson Warrants were accounted for as equity under ASC
815 – Derivatives and Hedging , and the grant date fair value was estimated to be $ 166,816 using Black-Scholes option pricing
model and is included in issuance costs related to the Convertible Debentures.
−Removed: The resulting discount is amortized over the term
−Removed: of the Convertible Debentures using the effective interest method.
−Removed: The Company recognized $ 266,193 of amortization of the discount during
−Removed: the year ended December 31, 2021, which was included within interest income (expense) in the consolidated statement of operations.
−Removed: remaining $ 463,465 of unamortized discount was credited to the capital accounts at the time of conversion.
+Added: The resulting discount is amortized
+Added: over the term of the Convertible Debentures using the effective interest method.
+Added: The Company recognized $ 266,193 of amortization of the
+Added: discount during the year ended December 31, 2021, which was included within interest income (expense) in the consolidated statement of
+Added: The remaining $ 463,465 of unamortized discount was credited to the capital accounts at the time of conversion.
The following table summarizes information
2 unchanged sentences
Weighted Average
−Removed: Life (in Years)
Common Stock Warrants
1 unchanged sentence
Class B Warrants
−Removed: The following assumptions were used in the Black-Scholes
−Removed: option pricing model to estimate the fair value of the warrants granted during the year ended December 31, 2021:
+Added: 1 Class B Warrants may also exercise such warrants on a “cashless”
+Added: See Class A Warrants and Class B Warrants subsection below.
+Added: No warrants were issued during the
+Added: year ended December 31, 2022.
+Added: The following assumptions were used in the Black-Scholes option pricing model to estimate the fair value
+Added: of the warrants granted during the year ended December 31, 2021:
Risk-free interest rate
4 unchanged sentences
Common Stock Warrants
−Removed: In March 2021,
−Removed: the Company granted to a financial advisor warrants to purchase 226,599 shares of the Company’s common stock (“Advisor Warrants”)
−Removed: as consideration for services in connection with the planned initial public offering (“IPO”).
−Removed: The warrants are exercisable
−Removed: at any time from the issuance date at the exercise price of $ 3.177 per share of common stock, subject to adjustment based on the amounts
−Removed: raised in the IPO, and have a 5 -year term.
−Removed: These warrants were accounted for as equity under ASC 815 – Derivatives and Hedging ,
−Removed: and the grant date fair value was estimated to be $ 180,339 using a Black-Scholes option pricing model and were netted against the IPO
−Removed: The terms of the advisory services agreement also provide for an incentive bonus of $ 200,000 payable upon closing of the IPO
−Removed: if such a closing occurs on or before January 31, 2022.
+Added: In March 2021, the Company granted
+Added: a financial advisor warrants to purchase 226,599 shares of the Company’s common stock (the “Advisor Warrants”) as consideration
+Added: for services in connection with the IPO.
+Added: The warrants are exercisable at any time from the issuance date at the exercise price of $ 3.177
+Added: per share of common stock, subject to adjustment based on the amounts raised in the IPO, and have a 5 -year term.
+Added: These warrants were accounted
+Added: for as equity and the grant date fair value was estimated to be $ 180,339 and were netted against the IPO proceeds.
+Added: The terms of the advisory
+Added: services agreement also provide for an incentive bonus of $ 200,000 payable upon closing of the IPO if such a closing occurs on or before
+Added: January 31, 2022.
This amount was netted against the IPO proceeds.
−Removed: As of December 31, 2021, all
−Removed: of the Advisor Warrants remain outstanding.
−Removed: In August 2021,
−Removed: the Company granted 225,000 warrants (“Dawson Warrants”) to its placement agent for compensation for their services in relation
−Removed: to the issuance of the Convertible Debentures (see Note 6).
−Removed: As of December 31, 2021, all of the Dawson Warrants remain outstanding.
−Removed: In November 2021,
−Removed: the Company granted 108,000 warrants (“Underwriter Warrants”) with an exercise price of $ 12.50 , and a fair value of approximately
+Added: As of December 31, 2022 and 2021, all of the Advisor Warrants remained
+Added: In August 2021, the Company granted
+Added: the Dawson Warrants to its placement agent for compensation for their services in relation to the issuance of the Convertible Debentures
+Added: (see Note 5).
+Added: As of December 31, 2022 and 2021, all of the Dawson Warrants remained outstanding.
+Added: In November 2021, the Company granted
+Added: 108,000 warrants (the “Underwriter Warrants”) with an exercise price of $ 12.50 , and a fair value of approximately $ 356,000 ,
to the underwriter of the IPO which is in addition to the cash fees paid for underwriting the Company’s IPO.
As of December 31,
−Removed: 31, 2021, all of the Underwriter Warrants remain outstanding.
−Removed: October 2020, in conjunction with the issuance of the Subordinated Notes, the Company granted 4,846,688 warrants (“Subordinated
−Removed: Note Warrants”) to the noteholders, of which 944,160 warrants were issued to LMBRI (see Note 5).
−Removed: 2021, the terms of some of the Subordinated Note Warrants were amended to provide for cashless exercise.
−Removed: During 2021, 4,718,251 of the
−Removed: Subordinated Note Warrants were exercised.
−Removed: As of December 31, 2021, 128,438 of the Subordinated Note Warrants were outstanding.
+Added: 2022 and 2021, all of the Underwriter Warrants remained outstanding.
+Added: In October 2020, in conjunction with
+Added: the issuance of the Subordinated Notes, the Company granted 4,846,688 warrants (the “Subordinated Note Warrants”) to the noteholders,
+Added: of which 944,160 were issued to LMBRI (see Note 4).
+Added: In November 2021, the terms of some of the Subordinated Note Warrants were amended
+Added: to provide for cashless exercise.
+Added: During 2021, 4,718,251 of the Subordinated Note Warrants were exercised.
+Added: As of December 31, 2022 and
+Added: 2021, 128,438 of the Subordinated Note Warrants were outstanding.
Class A Warrants and Class B
6 unchanged sentences
and $ 7,323,161 , respectively, were apportioned to the Class A Warrants and Class B Warrants.
−Removed: Class A Warrants entitle the holder to purchase
−Removed: one share of common stock at an exercise price of $ 7.00 per share.
−Removed: As of December 31, 2021 all Class A Warrants were outstanding.
+Added: Class A Warrants entitle the holder
+Added: to purchase one share of common stock at an exercise price of $ 7.00 per share.
+Added: As of December 31, 2022 and 2021 all Class A Warrants were
Class B Warrants entitle the holder
2 unchanged sentences
on a “cashless” basis after the earlier of (i) 10 trading days from closing date of the offering or (ii) the time when $10.0
−Removed: million of volume is traded in our common stock, if the volume weighted average price of the Company’s common stock on any trading
−Removed: day on or after the closing date of the offering fails to exceed the exercise price of the Class B Warrant (subject to adjustment as described
−Removed: in the warrant agreement).
−Removed: In such event, the aggregate number of shares of common stock issuable in such cashless exercise shall equal
−Removed: the product of (x) the aggregate number of shares of common stock that would be issuable upon exercise of the Class B Warrant in accordance
−Removed: with its terms if such exercise were by means of a cash exercise rather than a cashless exercise and (y) 1.00.
−Removed: During 2021, 2,368,500
−Removed: Class B Warrants were exercised, all on a cashless basis.
−Removed: As of December 31, 2021, 115,500 Class B Warrants were outstanding.
+Added: million of volume is traded in the Company’s common stock, if the volume weighted average price of the Company’s common stock
+Added: on any trading day on or after the closing date of the offering fails to exceed the exercise price of the Class B Warrant (subject to
+Added: adjustment as described in the warrant agreement).
+Added: During 2022 and 2021, respectively, 40,100 and 2,368,500 Class B Warrants were exercised,
+Added: all on a cashless basis.
+Added: As of December 31, 2022 and 2021, respectively, 75,400 and 115,500 Class B Warrants were outstanding.
Warrants for Series B Redeemable,
Convertible Preferred Stock
−Removed: The 643 Series B Warrants issued in
−Removed: conjunction with the Series B Preferred Stock (see Note 8) were accounted for as a derivative liability under ASC 480 – Distinguishing
−Removed: Liabilities from Equity and adjusted to their fair valued of at $ 155,629 as of December 31, 2020.
−Removed: On June 1, 2021, the Series B Warrants
−Removed: were amended (“Amended Series B Warrants”) to become exercisable into 115,190 shares of common stock at an exercise price
−Removed: of $ 2.30 per share and are now reflected as common stock warrants in the table of outstanding warrants above.
−Removed: The Amended Series B Warrants
−Removed: were accounted for as equity and reclassified from liabilities into additional paid-in capital at the fair value determined as of the
−Removed: amendment date of $ 145,953 .
−Removed: The fair value of the outstanding Series B redeemable
−Removed: preferred stock warrants at June 1, 2021 and December 31, 2020 was based on the assumptions as follows:
+Added: The 643 Series B Warrants (defined
+Added: below) issued in conjunction with the Series B redeemable, convertible preferred stock (see Note 7) were accounted for as a derivative
+Added: liability under ASC 480 – Distinguishing Liabilities from Equity.
+Added: On June 1, 2021, the Series B Warrants were amended (“Amended
+Added: Series B Warrants”) to become exercisable into 115,190 shares of common stock at an exercise price of $ 2.30 per share and are now
+Added: reflected as common stock warrants in the table of outstanding warrants above.
+Added: The Amended Series B Warrants were accounted for as equity
+Added: and reclassified from liabilities into additional paid-in capital at the fair value determined as of the amendment date of $ 145,953 .
+Added: The fair value of the outstanding the
+Added: Amended Series B Warrants at June 1, 2021 was based on the assumptions as follows:
Risk-free interest rate
0.31 % - 0.56 %
−Removed: 0.17 % - 0.36 %
Dividend rate
1 unchanged sentence
PREFERRED STOCK
−Removed: Series A, B and C Preferred Stock
−Removed: The Company’s Certificate of
−Removed: Incorporation, as amended on June 7, 2021, provided authorization for issuance of up to 35,000,000 shares, par value of $ 0.0001 , of which
−Removed: 30,000,000 shares shall be common stock and 5,000,000 shares shall be preferred stock.
−Removed: The Certificate of Incorporation was amended on
−Removed: October 22, 2021, to increase the authorized shares for preferred and common stock to 5,000,000 and 100,000,000 , respectively.
In 2017 in connection with the Financing
2 unchanged sentences
values of the Notes and Series A resulting in the Series A being recorded at $ 476,651 , net of $ 91,597 of issuance costs.
−Removed: were being accreted to the redemption value through December 31, 2021, the redemption date.
−Removed: Accretion of the Series A to redemption value,
−Removed: including the accretion of dividends and issuance costs, was $ 73,912 and $ 184,494 for years ended December, 2021 and 2020, respectively.
+Added: Series A were
+Added: being accreted to the redemption value through December 31, 2021, the redemption date.
+Added: Accretion of Series A to redemption value, including
+Added: the accretion of dividends and issuance costs, was $ 73,912 for year ended December 31, 2021.
In 2019, the Company entered into Subscription
−Removed: Agreements, as amended, for the issuance of 4,455 shares of Series B (the “Series B Financing”) plus the committed future
−Removed: issuance of 415 of additional shares.
−Removed: Combined, 4,732 shares of Series B at a purchase price of $ 361.50 per share were issued in 2019.
−Removed: Gross proceeds from the Series B Financing were approximately $ 1,710,000 in 2019.
−Removed: The Subscription Agreements, as amended, also specified
−Removed: that purchasers investing $150,000 or more in Series B were to be issued a five year stock purchase warrant (“Series B Warrants”)
−Removed: exercisable into a total number of Series B shares equal to 15 % of the purchase price divided by $ 361.50 .
−Removed: A total of 663 Series B Warrants
−Removed: were issued in 2019 in connection with the Series B Financing.
−Removed: The remaining Series B committed shares were drawn in January 2020 and
−Removed: the Company issued 138 shares of Series B and 21 Series B Warrants.
−Removed: In July and August 2020, the Company issued an additional 317 shares
−Removed: of Series B and 47 warrants to purchase Series B at an exercise price of $ 361.50 per share for gross proceeds of approximately $ 115,000 .
−Removed: The Series B were subject to accretion to the
−Removed: redemption value through December 31, 2024, the redemption date.
−Removed: Accretion of the Series B to redemption value, including the accretion
−Removed: of dividends and issuance costs, was $ 33,994 and $ 81,585 for the years ended December, 2021, respectively.
+Added: Agreements, as amended, for the issuance of 4,455 shares of Series B plus the committed future issuance of 415 of additional shares (the
+Added: “Series B Financing”).
+Added: The Series B Financing also resulted in the issuance of a total of 848 warrants (the “Series
+Added: B Warrants”).
+Added: Series B were subject to accretion to the redemption value through the redemption date.
+Added: Accretion of Series B to redemption
+Added: value, including the accretion of dividends and issuance costs, was $ 33,993 for the year ended December 31, 2021.
On November 19, 2020, the Company entered
−Removed: into a Subscription Agreement for the issuance of Series C (the “Series C Financing”) with Toray.
−Removed: In connection with the
−Removed: Series C Financing, the Company issued 636 shares of Series C at a purchase price of $ 1,578.50 per share.
−Removed: Proceeds from the Series C
−Removed: Financing, net of issuance costs, were $ 994,832 .
−Removed: The Series C were being accreted to the redemption value through December 31, 2021,
−Removed: the redemption date.
−Removed: Accretion of the Series C to redemption value, including the accretion of dividends and issuance costs, was $ 19,961
−Removed: for the year December 31, 2021.
−Removed: On June 1, 2021, in connection with the debt
−Removed: financing by Sabby (see Note 6), the Company’s Series A were converted into 1,668,016 shares of common stock, Series B were converted
−Removed: into 816,226 shares of common stock, and Series C were converted into 100,081 shares of common stock.
−Removed: The conversion was effected through
−Removed: the joint consent of the Company’s Board of Directors and shareholders and was subject to and in accordance with the terms of the
−Removed: Certificates of Designation.
−Removed: As a result of the conversion, the temporary equity balances at the conversion date were reclassified into
−Removed: the stockholders’ equity.
−Removed: The Series A ranked senior to Series B and Series
−Removed: Series B was pari passu with the Series C.
−Removed: Significant terms of the Series A, Series B and Series C (collectively, “Voting Preferred
−Removed: Stock”) were as follows:
−Removed: ● Voting - The holder of each share of Voting
−Removed: Preferred Stock has the right to vote for each share of common stock into which such Preferred Stock could convert.
−Removed: Except as otherwise
−Removed: provided, the holders of Voting Preferred Stock and Common Stock shall vote together as a single class.
−Removed: ● Dividends - The holders of Voting Preferred
−Removed: Stock shall be entitled to receive dividends at a rate per annum of 4 %.
−Removed: Dividends shall accrue whether or not declared and are cumulative.
−Removed: The dividends shall be paid quarterly on the first day of March, June, September, and December only if and when declared by the Board
−Removed: of Directors.
−Removed: No dividends have been declared by the Company to date.
−Removed: ● Liquidation Preference- In the event of
−Removed: any liquidation, dissolution or winding up of the Company, the holders of Series A shall be entitled to be paid out of the assets of the
−Removed: Company, after all creditors of the Company have been paid, before any payments shall be made to the holders of Series B, Series C and
−Removed: common stock, in the amount of the Original Offering Price per share, plus all accrued but unpaid dividends thereon.
−Removed: If insufficient assets
−Removed: and funds are available to permit payment to the Series A holders, then all available assets and funds shall be distributed to the Series
−Removed: A holders on a pro rata basis.
−Removed: All dividends accrued and unpaid to the date of such distribution shall be paid out of the assets of the
−Removed: Company before any distribution is made to the holders of any junior stock of the Company.
−Removed: ● In the event of any liquidation, dissolution
−Removed: or winding up of the Company, the holders of Series B and Series C, which are pari passu stocks, shall be entitled to be paid out of the
−Removed: assets of the Company before any payments shall be made to the holders of the common stock, in the amount of the Original Offering Price
−Removed: per share, plus all accrued but unpaid dividends thereon.
−Removed: If insufficient assets and funds are available to permit payment to the Series
−Removed: B and Series C holders, then all available assets and funds shall be distributed to the Series B and Series C holders on a pro rata basis.
−Removed: All dividends accrued and unpaid to the date of such distribution shall be paid out of the assets of the Company before any distribution
−Removed: is made to the holders of any junior stock of the Company.
−Removed: ● Conversion - Each share of Voting Preferred
−Removed: Stock is entitled to convert into 157.36 shares of common stock at $ 0.64 , $ 2.30 and $ 10.03 per share, respectively, at any time by the
−Removed: holder following issuance.
−Removed: ● Redemption - If the Company has not had
−Removed: an Initial Public Offering, or has not been acquired by December 31, 2024, the Company will be required, upon request of the holders of
−Removed: at least two thirds of the outstanding shares, to redeem the outstanding Preferred Stock at the greater of (i) Original Offering Price,
−Removed: plus accrued dividends, or (ii) the fair market value as determined by an appraiser selected by Company who is reasonably acceptable to
−Removed: the holders of a majority of the outstanding Preferred Stock and paid for by the Company.
−Removed: Series D Preferred Stock
+Added: into a Subscription Agreement for the issuance of Series C redeemable, convertible preferred stock (the “Series C Financing”)
+Added: In connection with the Series C Financing, the Company issued 636 shares of Series C at a purchase price of $ 1,578.50 per
+Added: Proceeds from the Series C Financing, net of issuance costs, were $ 994,832 .
+Added: Series C were being accreted to the redemption value
+Added: through December 31, 2021, the redemption date.
+Added: Accretion of Series C to redemption value, including the accretion of dividends and issuance
+Added: costs, was $ 19,961 for the year December 31, 2021.
+Added: On June 1, 2021, in connection with
+Added: the Sabby Agreement (see Note 5), Series A were converted into 1,668,016 shares of common stock, Series B were converted into 816,226
+Added: shares of common stock, and Series C were converted into 100,081 shares of common stock.
+Added: The conversion was affected through the joint
+Added: consent of the Company’s Board of Directors and stockholders and was subject to and in accordance with the terms of the Certificates
+Added: of Designation.
+Added: As a result of the conversion, the temporary equity balances at the conversion date were reclassified into the stockholders’
On June 7, 2021, the Company filed
1 unchanged sentence
preferred stock (“Series D”).
−Removed: Each share of Series D shall have a par value of $ 0.0001 per share and a stated value equal
−Removed: Series D has no voting rights, and is convertible into 1,000 shares of Common Stock at $ 1.00 per share at any time following
−Removed: In connection with the IPO, on November 10, 2021, all of the Company’s outstanding Convertible Debentures automatically
−Removed: converted into 4,500 shares of Series D Preferred Stock.
−Removed: In November 2021, all Series D Preferred stock was converted into 4,500,000 shares
−Removed: of common stock.
−Removed: There were no Series D outstanding as of December 31, 2021.
+Added: In connection with the IPO, all of the outstanding Convertible Debentures automatically converted
+Added: into 4,500 shares of Series D on the IPO Date.
+Added: In November 2021, all Series D was converted into 4,500,000 shares of common stock.
+Added: were no Series D outstanding as of December 31, 2022.
STOCK COMPENSATION
−Removed: In 2018, the Company adopted the 2018 Stock Incentive
−Removed: Plan (the “2018 Plan”) for employees, consultants, and directors.
−Removed: The 2018 Plan, which is administered by the Board of Directors,
−Removed: permits the Company to grant incentive and nonqualified stock options for the purchase of common stock, and restricted stock awards.
−Removed: maximum number of shares reserved for issuance under the 2018 Plan is 629,440 .
+Added: Stock Incentive Plans
+Added: In 2018, the Company adopted the 2018
+Added: Stock Incentive Plan (the “2018 Plan”) for employees, consultants, and directors.
+Added: The 2018 Plan, which is administered by
+Added: the Company’s Board of Directors, permits the Company to grant incentive and nonqualified stock options for the purchase of common
+Added: stock, and restricted stock awards.
+Added: The maximum number of shares of common stock reserved for issuance under the 2018 Plan is 629,440 .
+Added: At December 31, 2022 there were 262,269 shares of common stock available for grant under the 2018 Plan.
On July 6, 2021, the Company’s Board of
2 unchanged sentences
1,960,000 shares of common stock were approved to be initially reserved for issuance under the 2021 Stock Plan.
−Removed: The Company can continue
−Removed: to issue shares under the 2018 Plan.
−Removed: At December 31, 2021, there were 1,681,000 and 262,269 shares available for grants under the 2021
−Removed: and 2018 Plans, respectively.
−Removed: The Company calculated the grant-date
−Removed: fair value of share-based awards granted during the years ended December 31, 2021 and 2020 using the Black-Scholes model with the following
−Removed: Year Ended December 31,
+Added: At December 31, 2022 there
+Added: were 1,339,721 shares of common stock available for grant under the 2021 Plan.
+Added: Stock Award Activity
+Added: The following table summarizes the status of the
+Added: Company’s non-vested restricted stock awards for years ended December 31, 2022:
+Added: Restricted Stock Awards
+Added: Outstanding at December 31, 2021
+Added: Outstanding at December, 2022
+Added: The following is a summary of stock option activity for the year ended
+Added: December 31, 2022:
+Added: Outstanding at December 31, 2021
+Added: Cancelled and forfeited
+Added: Outstanding at December 31, 2022
+Added: Exercisable at December 31, 2022
+Added: The weighted average grant date fair
+Added: value of options granted during the years ended December 31, 2022 and 2021 was $ 1.42 per share and $ 1.16 per share, respectively.
+Added: Company calculated the grant-date fair value of stock option awards granted during the years ended December 31, 2022 and 2021 using the
+Added: Black-Scholes model with the following assumptions:
Risk-free interest rate
4 unchanged sentences
102.03 % – 107.36 %
+Added: 106.00 % – 114.76 %
Expected life of option (in years)
−Removed: The following is a summary of stock option activity for the year ended
−Removed: December 31, 2021:
−Removed: Life in Years
−Removed: Intrinsic Value
−Removed: Outstanding at December 31, 2020
−Removed: Cancelled and forfeited
−Removed: Outstanding at December 31, 2021
−Removed: Exercisable at December 31, 2021
−Removed: The weighted average grant date fair value of
−Removed: options granted during the years ended December 31, 2021 and 2020 was $ 1.16 per share and $ 0.65 per share, respectively
+Added: Stock-Based Compensation Expense
For the years ended December 31, 2022
8 unchanged sentences
period of 2.2 years.
+Added: At December 31, 2022, there was approximately $ 50,859 of unrecognized compensation expense related to non-vested
+Added: restricted stock awards that are expected to be recognized over a weighted-average period of 2.1 years.
RELATED PARTY TRANSACTIONS
+Added: Lana Management and Business
+Added: Research International, LLC
Lana Management and Business Research
−Removed: International, LLC
−Removed: LMBRI has board members in common with
−Removed: Funds were advanced to the Company by LMBRI for operational and Food and Drug Administration (“FDA”) pre-submission
−Removed: funding purposes since inception.
−Removed: The outstanding balance due to LMBRI is payable upon demand.
−Removed: The Company and LMBRI have entered
−Removed: into an Expense Sharing Agreement, whereby the Company will reimburse LMBRI monthly for certain shared expenses including insurance,
−Removed: rent, salaries, telephone, and other miscellaneous expenses.
−Removed: The Company is billed $ 4,000 monthly for these expenses.
−Removed: Such amounts are
−Removed: included in general and administrative expenses on the accompanying consolidated statements of operations.
−Removed: The Company also issued Subordinated
−Removed: Notes and Common Stock Warrants to LMBRI in October 2020 as described in Note 5.
+Added: International, LLC (“LMBRI”) has board members in common with the Company.
+Added: The Company and LMBRI entered into an Expense Sharing
+Added: Agreement, whereby the Company will reimburse LMBRI monthly for certain shared expenses including insurance, rent, salaries, telephone,
+Added: and other miscellaneous expenses.
+Added: The Company was billed $ 4,000 monthly for these expenses through December 31, 2021.
+Added: On January 1, 2022,
+Added: the Company moved into its own leased facility and no longer shared expenses with LMBRI Such amounts are included in general and administrative
+Added: expenses on the accompanying consolidated statements of operations.
+Added: The Company also issued Subordinated Notes and Warrants to LMBRI in
+Added: October 2020 as described in Note 4.
The table below summarizes the amounts
4 unchanged sentences
Interest Incurred and Payments on Subordinated Notes to LMBRI (Note 4)
−Removed: Portion of Subordinated Notes payable to LMBRI (Note 5)
NanoHybrids, LLC
−Removed: In December 2021, the Company entered into an
−Removed: agreement with NanoHybids, LLC (“NanoHybrids) to utilize the Company’s research and development staff and laboratory facility
−Removed: when available to perform work for NanoHybrids.
−Removed: Any hours worked by Company employees for NanoHybrids is billed to NanoHyrids at a bill
−Removed: rate of the respective employee’s fully burdened personnel cost plus 10 %.
−Removed: NanoHybrids is wholly owned by the Company’s Chief
−Removed: Technology Officer.
−Removed: There were no amounts incurred, paid or balances due related to this agreement for the year ended and as of December
+Added: In December 2021, the Company entered
+Added: into an agreement with NanoHybrids, LLC (“NanoHybrids”) to utilize the Company’s research and development staff and
+Added: laboratory facility when available to perform work for NanoHybrids.
+Added: Any hours worked by Company employees for NanoHybrids is billed to
+Added: NanoHybrids at a bill rate of the respective employee’s fully burdened personnel cost plus 10 %.
+Added: NanoHybrids is wholly owned by the
+Added: Company’s Chief Technology Officer.
+Added: The table below summarizes the amounts earned and due from NanoHybrids for the years ended December
+Added: 31, 2022 and 2021 and balances due as of December 31, 2022 and 2021:
+Added: Income from NanoHybrids included in Other Income
+Added: Cash receipts from NanoHybrids
+Added: As of December 31,
+Added: Amounts receivable from NanoHybrids included in Prepaids and Other Current Assets
+Added: Toray Industries, Inc.
+Added: In June 2022, the Company sold five Symphony analyzers
+Added: to the Company’s business partner, Toray, for $ 249,040 , all of which was paid in June 2022.
+Added: Future sales to Toray are not currently
SUPPLEMENTAL BALANCE SHEET INFORMATION
−Removed: Prepaid expenses and other current assets consist
−Removed: of the following:
+Added: Prepaid expenses and other current
+Added: assets consist of the following:
Prepaid insurance
Prepaid clinical trial expenses
+Added: Vendor prepayments
Prepaid other
Total prepaid expenses and other current assets
−Removed: Accrued expenses and other current liabilities
−Removed: consist of the following:
+Added: Accrued expenses and other current
+Added: liabilities consist of the following:
Accrued personnel costs
1 unchanged sentence
Total accrued expenses and other current liabilities
−Removed: AND EQUIPMENT
−Removed: Property and equipment consisted
−Removed: of the following at December 31, 2021 and 2020:
+Added: PROPERTY AND EQUIPMENT
+Added: Property and equipment consisted of
+Added: the following at December 31, 2022 and 2021:
Depreciable lives
2 unchanged sentences
Lab equipment
+Added: Leasehold improvements
+Added: Life of lease
accumulated depreciation
Property and equipment, net
+Added: The Company primarily enters into lease arrangements
+Added: for office and laboratory space.
+Added: A summary of supplemental lease information is as follows:
+Added: Weighted average remaining lease term – operating leases (in years)
+Added: Weighted average remaining lease term – finance leases (in years)
+Added: Weighted average discount rate
+Added: Operating cash flows from operating leases
+Added: A summary of the Company’s lease assets and liabilities are as
+Added: Operating lease right-of-use asset
+Added: Finance lease asset included in property & equipment, net
+Added: Total lease assets
+Added: Current portion of operating lease liability
+Added: Current portion of finance lease liability included in accrued expenses
+Added: Non-current operating lease liabilities
+Added: Non-current finance lease liabilities included in other non-current liabilities
+Added: Total lease liabilities
+Added: A summary of the Company’s estimated operating lease payments
+Added: are as follows:
+Added: Total future lease payments
+Added: Imputed interest
+Added: Present value of lease liability
COMMITMENTS AND CONTINGENCIES
Purchase Commitments
−Removed: As of December 31, 2021, the Company has entered
−Removed: into non-cancelable purchase commitments primarily for inventory and key advisory services.
−Removed: The purchase commitments covered by these
−Removed: agreements are for less than one year and aggregate to approximately $ 1.5 million.
−Removed: Lease Commitments
−Removed: In October 2021, the Company entered into a lease
−Removed: for laboratory space that expires on October 31, 2024.
−Removed: Additionally in 2021, we signed a lease for office space that is expected to commence
−Removed: in April 2022 when the buildout of the space is expected to be completed.
−Removed: The office space lease expires on March 30, 2027.
−Removed: A summary of the Company’s estimated lease payments are as follows:
−Removed: Total future lease payments
+Added: In October 2022, the Company entered
+Added: into a non-cancelable purchase commitment with an international materials vendor for items needed for both development of the Symphony
+Added: product line and also to resell to its customers.
+Added: This agreement commits the Company to purchase approximately $ 800,000 in goods, of which
+Added: 50 % was prepaid in 2022.
+Added: No goods have been received under this arrangement as of December 31, 2022.
+Added: The Company had multiple open purchase
+Added: commitments with its primary contract manufacturing organization in Japan related to the buildout of a manufacturing line for the IL-6
+Added: cartridges for the Symphony device.
+Added: As of December 31, 2022, the total open non-cancellable commitments for the manufacturing line buildout
+Added: totaled approximately $ 375,000 .
+Added: As of December 31, 2022, the Company
+Added: has entered into other non-cancelable purchase commitments primarily for R&D supplies and key advisory services.
+Added: The purchase commitments
+Added: covered by these agreements are for less than one year and aggregate to approximately $ 700,000 .
Minimum Royalties
−Removed: As required under the Toray Agreement
−Removed: (see Note 3), following the first sale of Toray Chips, the Company will also make royalty payments to Toray equal to 15% of the net sales
−Removed: of the Toray Chips for the period that any underlying patents exist or for 5 years after the first sale.
+Added: As required under the License Agreement
+Added: (see Note 3), following the first sale of Cartridges, the Company will also make royalty payments to Toray equal to 15% of the net sales
+Added: of the Cartridges for the period that any underlying patents exist or for 5 years after the first sale.
Following the first sale, the
2 unchanged sentences
in such calendar year.
−Removed: There were no sales of or revenues from the Toray Chips through December 31, 2021.
+Added: There were no sales of or revenues from the Cartridges through December 31, 2022.
Indemnification
−Removed: The Company has certain agreements with service
−Removed: providers with which it does business that contain indemnification provisions pursuant to which the Company typically agrees to indemnify
−Removed: the party against certain types of third-party claims.
−Removed: The Company accrues for known indemnification issues when a loss is probable and
−Removed: can be reasonably estimated.
−Removed: The Company would also accrue for estimated incurred but unidentified indemnification issues based on historical
−Removed: As the Company has not incurred any indemnification losses to date, there were no accruals for or expenses related to indemnification
−Removed: issues for any period presented.
−Removed: No provision for federal income
−Removed: taxes has been recorded for the years ended December 31, 2021 and 2020 due to net losses and the valuation allowance established.
−Removed: Significant components of
−Removed: the Company’s deferred tax assets are as follows:
+Added: The Company has certain agreements
+Added: with service providers with which it does business that contain indemnification provisions pursuant to which the Company typically agrees
+Added: to indemnify the party against certain types of third-party claims.
+Added: The Company accrues for known indemnification issues when a loss is
+Added: probable and can be reasonably estimated.
+Added: The Company would also accrue for estimated incurred but unidentified indemnification issues
+Added: based on historical activity.
+Added: As the Company has not incurred any indemnification losses to date, there were no accruals for or expenses
+Added: related to indemnification issues for any period presented.
+Added: No provision for federal income taxes
+Added: has been recorded for the years ended December 31, 2022 and 2021 due to net losses and the valuation allowance established.
+Added: Significant components of the Company’s
+Added: deferred tax assets are as follows:
As of December 31,
2 unchanged sentences
Intangible assets
+Added: Capitalized R&D expenses
Total deferred tax assets
1 unchanged sentence
( 4,628,641 )
+Added: ( 1,934,351 )
Net deferred tax assets
Deferred tax liabilities:
−Removed: Note premium amortization
Net deferred tax assets
−Removed: A reconciliation of the statutory
−Removed: tax rates and the effective tax rates for the years ended December 2021 and 2020 is as follows:
+Added: A reconciliation of the statutory tax
+Added: rates and the effective tax rates for the years ended December 2022 and 2021 is as follows:
Year Ended December 31,
4 unchanged sentences
Effective tax rate
−Removed: The Company regularly assesses
−Removed: the need for a valuation allowance against its deferred tax assets.
−Removed: In making that assessment, the Company considers both positive and
−Removed: negative evidence related to the likelihood of realization of the deferred tax assets to determine, based on the weight of available evidence,
+Added: The Company regularly assesses the
+Added: need for a valuation allowance against its deferred tax assets.
+Added: In making that assessment, the Company considers both positive and negative
+Added: evidence related to the likelihood of realization of the deferred tax assets to determine, based on the weight of available evidence,
whether it is more-likely-than-not that some or all of the deferred tax assets will not be realized.
5 unchanged sentences
a jurisdiction-by-jurisdiction basis.
−Removed: The Company continues to maintain
−Removed: a full valuation allowance against its net deferred tax assets.
−Removed: During the years ended December 31, 2021 and 2020, management assessed
−Removed: the positive and negative evidence in its operations, and concluded that it is more likely than not that its deferred tax assets as of
−Removed: December 31, 2020 and 2019 will not be realized given the Company’s history of operating losses.
−Removed: The valuation allowance against
−Removed: deferred tax assets increased by approximately $ 937,000 and $ 335,000 and during 2021 and 2020, respectively, related mainly to a full
−Removed: valuation allowance recorded against additional net operating losses and tax credits generated in the year.
−Removed: At December 31, 2021,
−Removed: the Company had federal net operating loss carryforwards of approximately $ 6.6 million.
−Removed: The Company’s federal net operating
−Removed: losses incurred prior to 2018 totaling $ 713,000 expire through 2037, while its federal net operating losses incurred in 2018 to 2021
−Removed: totaling $ 5.9 million have no expiration date as a result of the December 22, 2017 Tax Cuts and Jobs Act tax reform legislation.
−Removed: As of December 31, 2021,
−Removed: the Company had post-apportioned state net operating losses of $ 6.3 million that can generally be carried forward 20 years and will expire
+Added: The Company continues to maintain a
+Added: full valuation allowance against its net deferred tax assets.
+Added: During the years ended December 31, 2022 and 2021, management assessed the
+Added: positive and negative evidence in its operations and concluded that it is more likely than not that its deferred tax assets as of December
+Added: 31, 2022 and 2021 will not be realized given the Company’s history of operating losses.
+Added: The valuation allowance against deferred
+Added: tax assets increased by approximately $ 2.7 million and $ 900,000 and during 2022 and 2021, respectively, related mainly to a full valuation
+Added: allowance recorded against capitalized research expenditures, additional net operating losses and tax credits generated in the year.
+Added: At December 31, 2022, the Company
+Added: had federal net operating loss carryforwards of approximately $ 11.2 million.
+Added: The Company’s federal net operating losses incurred
+Added: prior to 2018 totaling $ 713,000 expire through 2037, while its federal net operating losses incurred in 2018 to 2022 totaling $ 10.5 million
+Added: can be carried forward indefinitely.
+Added: As of December 31, 2022, the
+Added: Company had post-apportioned state net operating losses of $ 10.9 million that can generally be carried forward 20 years and will expire
at various dates through 2042.
1 unchanged sentence
million that can generally be carried forward 20 years and will expire at various dates through 2041.
−Removed: INDEX TO EXHIBITS
−Removed: Description of Document
−Removed: Amended and Restated Certificate of Incorporation.
−Removed: (incorporated by reference to exhibit 3.1 to the Company’s Form S-1 file no.
−Removed: Amended and Restated Bylaws.
−Removed: (incorporated by reference to exhibit 3.2 to the Company’s Form S-1 file no.
−Removed: Specimen Common Stock Certificate.
−Removed: (incorporated by reference to exhibit 4.1 to the Company’s Form S-1 file no.
−Removed: Form of Class A Warrant.
−Removed: (incorporated by reference to exhibit 4.1 to the Company’s Form 8-K filed November 16, 2021)
−Removed: Form of Class B Warrant.
−Removed: (incorporated by reference to exhibit 4.3 to the Company’s Form S-1 file no.
−Removed: Form of Warrant Agency Agreement.
−Removed: (incorporated by reference to exhibit 4.4 to the Company’s Form S-1 file no.
−Removed: Form of IPO Underwriters’ Warrant.
−Removed: (incorporated by reference to exhibit 4.5 to the Company’s Form S-1 file no.
−Removed: Description of Securities of Bluejay Diagnostics, Inc.
−Removed: 2021 Stock Plan.
−Removed: (incorporated by reference to exhibit 10.1 to the Company’s Form S-1 file no.
−Removed: License and Supply Agreement dated October 6, 2020 by and between Toray Industries, Inc.
−Removed: and Bluejay Diagnostics, Inc.
−Removed: (incorporated by reference to exhibit 10.2 to the Company’s Form S-1 file no.
−Removed: Employment Agreement dated July 1, 2021 between Neil Dey and Bluejay Diagnostics, Inc.
−Removed: (incorporated by reference to exhibit 10.3 to the Company’s Form S-1 file no.
−Removed: Employment Agreement dated July 1, 2021 between Gordon Kinder and Bluejay Diagnostics, Inc.
−Removed: (incorporated by reference to exhibit 10.4 to the Company’s Form S-1 file no.
−Removed: Employment Agreement dated July 1, 2021 between Jason Cook and Bluejay Diagnostics, Inc.* (incorporated by reference to exhibit 10.5 to the Company’s Form S-1 file no.
−Removed: Employment Agreement dated July 1, 2021 between Kevin Vance and Bluejay Diagnostics, Inc.
−Removed: (incorporated by reference to exhibit 10.6 to the Company’s Form S-1 file no.
−Removed: Securities Purchase Agreement dated June 7, 2021 between certain purchasers and Bluejay Diagnostics, Inc.
−Removed: (incorporated by reference to exhibit 10.7 to the Company’s Form S-1 file no.
−Removed: Registration Rights Agreement dated June 7, 2021 between certain purchasers and Bluejay Diagnostics, Inc.
−Removed: (incorporated by reference to exhibit 10.8 to the Company’s Form S-1 file no.
−Removed: Amendment to License and Supply Agreement dated July 21, 2021 by and between Toray Industries, Inc.
−Removed: and Bluejay Diagnostics, Inc.
−Removed: (incorporated by reference to exhibit 10.9 to the Company’s Form S-1 file no.
−Removed: Code of Ethics.
−Removed: (incorporated by reference to exhibit 14.1 to the Company’s Form S-1 file no.
−Removed: List of Subsidiaries.
−Removed: (incorporated by reference to exhibit 21.1 to the Company’s Form S-1 file no.
−Removed: Certification of Principal Executive Officer pursuant to Rule 13a-14 of the Securities Exchange Act of 1934, as amended
−Removed: Certification of Principal Financial Officer pursuant to Rule 13a-14 of the Securities Exchange Act of 1934, as amended
−Removed: Certification of Principal Executive Officer Pursuant to Section 18 U.S.C.
−Removed: Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
−Removed: Certification of Principal Financial Officer Pursuant to Section 18 U.S.C.
−Removed: Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
−Removed: Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document)
−Removed: Inline XBRL Taxonomy Extension Schema Document
−Removed: Inline XBRL Taxonomy Extension Calculation Linkbase Document
−Removed: Inline XBRL Taxonomy Extension Definition Linkbase Document
−Removed: Inline XBRL Taxonomy Extension Label Linkbase Document
−Removed: Inline XBRL Taxonomy Extension Presentation Linkbase Document
−Removed: Cover Page Interactive Data File (formatted in IXBRL, and included in exhibit 101).
−Removed: * Filed herewith.
−Removed: ** Management contract or compensatory plan, contract or arrangement.
+Added: The Tax Cuts and Jobs Act resulted in significant changes to the treatment
+Added: of research or experimental (“R&E”) expenditures under Section 174.
+Added: For tax years beginning after December 31, 2021, taxpayers
+Added: are required to capitalize and amortize all R&E expenditures that are paid or incurred in connection with their trade or business
+Added: which represent costs in the experimental or laboratory sense.
+Added: Specifically, costs for U.S.
+Added: based R&E activities must be amortized
+Added: over five years and costs for foreign R&E activities must be amortized over 15 years;
+Added: both using a midyear convention.
+Added: has implemented this standard on January 1, 2022, noting that the impact on the Company’s consolidated financial statements was
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.