Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 07, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2023 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2023 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-35853 | |
Entity Registrant Name | Harvard Apparatus Regenerative Technology, Inc. | |
Entity Central Index Key | 0001563665 | |
Entity Tax Identification Number | 45-5210462 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 84 October Hill Road, Suite 11 | |
Entity Address, City or Town | Holliston | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 01746 | |
City Area Code | (774) | |
Local Phone Number | 233-7300 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 13,882,060 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 2,140 | $ 1,241 |
Short-term investments | 2,523 | |
Prepaid research and development | 259 | 274 |
Prepaid expenses and other current assets | 79 | 79 |
Total current assets | 5,001 | 1,594 |
Property, plant and equipment, net | 39 | 49 |
Right-of-use assets, net | 135 | 147 |
Deferred financing costs | 544 | 610 |
Other long-term assets | 62 | |
Total assets | 5,781 | 2,400 |
Current liabilities: | ||
Accounts payable | 372 | 682 |
Accrued and other current liabilities | 1,476 | 582 |
Operating lease liability, current | 119 | 99 |
Total current liabilities | 1,967 | 1,363 |
Operating lease liability, net of current portion | 18 | 48 |
Total liabilities | 1,985 | 1,411 |
Commitments and contingencies (Note 7) | ||
Series E convertible preferred stock, par value $0.01 per share, 5,000 shares authorized; 0 and 4,180 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | 4,180 | |
Stockholders’ equity (deficit): | ||
Common stock, par value $0.01 per share, 60,000,000 shares authorized; 13,882,060 and 12,174,467 issued and outstanding at June 30, 2023 and December 31, 2022, respectively | 139 | 122 |
Additional paid-in capital | 92,172 | 79,698 |
Accumulated deficit | (88,515) | (83,011) |
Total stockholders’ equity (deficit) | 3,796 | (3,191) |
Total liabilities and stockholders’ equity (deficit) | $ 5,781 | $ 2,400 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Series E convertible preferred stock, par value, per share | $ 0.01 | $ 0.01 |
Series E convertible preferred stock, shares authorized | 5,000 | 5,000 |
Series E convertible preferred stock, shares issued | 0 | 4,180 |
Series E convertible preferred stock, shares outstanding | 0 | 4,180 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 60,000,000 | 60,000,000 |
Common stock, shares issued | 13,882,060 | 12,174,467 |
Common stock, shares outstanding | 13,882,060 | 12,174,467 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Operating expenses: | ||||
Research and development | $ 1,566 | $ 326 | $ 2,075 | $ 629 |
Selling, general and administrative | 1,085 | 1,049 | 3,463 | 2,951 |
Total operating expenses | 2,651 | 1,375 | 5,538 | 3,580 |
Operating loss | (2,651) | (1,375) | (5,538) | (3,580) |
Other income, net: | ||||
Sublease income | 32 | 61 | ||
Other income (expense), net | 37 | (2) | 34 | (3) |
Total other income, net | 37 | 30 | 34 | 58 |
Net loss | (2,614) | (1,345) | (5,504) | (3,522) |
Preferred stock dividends | 3 | (18) | (77) | (18) |
Net loss attributable to common stockholders | $ (2,611) | $ (1,363) | $ (5,581) | $ (3,540) |
Basic net loss per share | $ (0.19) | $ (0.12) | $ (0.43) | $ (0.32) |
Diluted net loss per share | $ (0.19) | $ (0.12) | $ (0.43) | $ (0.32) |
Weighted average common shares, basic | 13,785,657 | 11,230,525 | 13,000,211 | 10,996,996 |
Weighted average common shares, diluted | 13,785,657 | 11,230,525 | 13,000,211 | 10,996,996 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited) - USD ($) $ in Thousands | Series E Convertible Preferred Stock [Member] Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Dec. 31, 2021 | $ 108 | $ 73,801 | $ (76,938) | $ (3,029) | |
Temporary equity, beginning balance, shares at Dec. 31, 2021 | |||||
Beginning balance, shares at Dec. 31, 2021 | 10,760,871 | ||||
Preferred stock dividends | (18) | (18) | |||
Temporary equity, preferred stock dividends | 18 | ||||
Issuance of common stock, net of offering costs | $ 8 | 5,052 | 5,060 | ||
Issuance of common stock, net of offering costs, shares | 854,771 | ||||
Share-based compensation expense | 512 | 512 | |||
Net loss | (3,522) | (3,522) | |||
Issuance of series E convertible preferred stock | |||||
Issuance of series E convertible preferred stock | 4,000 | ||||
Ending balance, value at Jun. 30, 2022 | $ 116 | 79,347 | (80,460) | (997) | |
Temporary equity, ending balance, shares at Jun. 30, 2022 | 4,018 | ||||
Ending balance, shares at Jun. 30, 2022 | 11,615,642 | ||||
Beginning balance, value at Mar. 31, 2022 | $ 108 | 74,036 | (79,115) | (4,971) | |
Temporary equity, beginning balance, shares at Mar. 31, 2022 | |||||
Beginning balance, shares at Mar. 31, 2022 | 10,760,871 | ||||
Preferred stock dividends | (18) | (18) | |||
Temporary equity, preferred stock dividends | 18 | ||||
Issuance of common stock, net of offering costs | $ 8 | 5,052 | 5,060 | ||
Issuance of common stock, net of offering costs, shares | 854,771 | ||||
Share-based compensation expense | 277 | 277 | |||
Net loss | (1,345) | (1,345) | |||
Issuance of series E convertible preferred stock | |||||
Issuance of series E convertible preferred stock | 4,000 | ||||
Ending balance, value at Jun. 30, 2022 | $ 116 | 79,347 | (80,460) | (997) | |
Temporary equity, ending balance, shares at Jun. 30, 2022 | 4,018 | ||||
Ending balance, shares at Jun. 30, 2022 | 11,615,642 | ||||
Beginning balance, value at Dec. 31, 2022 | $ 122 | 79,698 | (83,011) | (3,191) | |
Temporary equity, beginning balance, shares at Dec. 31, 2022 | 4,180 | 4,180 | |||
Beginning balance, shares at Dec. 31, 2022 | 12,174,467 | ||||
Preferred stock dividends | (77) | (77) | |||
Temporary equity, preferred stock dividends | 77 | ||||
Conversion of preferred stock for common stock | $ 7 | 4,250 | 4,257 | ||
Temporary equity, conversion of preferred stock for common stock | (4,257) | ||||
Conversion of preferred stock for common stock, shares | 706,626 | ||||
Issuance of common stock, net of offering costs | $ 10 | 5,982 | 5,992 | ||
Issuance of common stock, net of offering costs, shares | 1,000,967 | ||||
Share-based compensation expense | 2,319 | 2,319 | |||
Net loss | (5,504) | (5,504) | |||
Ending balance, value at Jun. 30, 2023 | $ 139 | 92,172 | (88,515) | 3,796 | |
Temporary equity, ending balance, shares at Jun. 30, 2023 | |||||
Ending balance, shares at Jun. 30, 2023 | 13,882,060 | ||||
Beginning balance, value at Mar. 31, 2023 | $ 127 | 84,712 | (85,901) | (1,062) | |
Temporary equity, beginning balance, shares at Mar. 31, 2023 | 4,051 | ||||
Beginning balance, shares at Mar. 31, 2023 | 12,716,534 | ||||
Preferred stock dividends | 3 | 3 | |||
Temporary equity, preferred stock dividends | (3) | ||||
Conversion of preferred stock for common stock | $ 7 | 4,041 | 4,048 | ||
Temporary equity, conversion of preferred stock for common stock | (4,048) | ||||
Conversion of preferred stock for common stock, shares | 674,693 | ||||
Issuance of common stock, net of offering costs | $ 5 | 2,937 | 2,942 | ||
Issuance of common stock, net of offering costs, shares | 490,833 | ||||
Share-based compensation expense | 479 | 479 | |||
Net loss | (2,614) | (2,614) | |||
Ending balance, value at Jun. 30, 2023 | $ 139 | $ 92,172 | $ (88,515) | 3,796 | |
Temporary equity, ending balance, shares at Jun. 30, 2023 | |||||
Ending balance, shares at Jun. 30, 2023 | 13,882,060 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
OPERATING ACTIVITIES | ||
Net loss | $ (5,504) | $ (3,522) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation expense | 2,319 | 512 |
Depreciation | 23 | 27 |
Change in fair value of warrant liability | (2) | |
Changes in operating assets and liabilities: | ||
Prepaid research and development | 15 | |
Prepaid expenses and other current assets | 198 | |
Deferred financing costs | 66 | (173) |
Other long-term assets | (62) | |
Accounts payable | (310) | 823 |
Accrued and other current liabilities | 894 | 483 |
Net cash used in operating activities | (2,559) | (1,654) |
INVESTING ACTIVITIES | ||
Purchases of short-term investments | (2,523) | |
Purchases of property, plant, and equipment | (11) | (8) |
Net cash used in investing activities | (2,534) | (8) |
FINANCING ACTIVITIES | ||
Proceeds from issuance of common stock | 5,992 | 5,060 |
Net cash provided by financing activities | 5,992 | 5,060 |
Net increase in cash and cash equivalents | 899 | 3,398 |
Cash and cash equivalents at the beginning of the year | 1,241 | 1,292 |
Cash and cash equivalents at the end of the period | 2,140 | 4,690 |
Supplemental disclosure of non-cash activities: | ||
Settlement of contingency matter | (3,250) | |
Settlement of due to Harvard Bioscience included in accrued and other current liabilities | (750) | |
Issuance of Series E convertible preferred stock | 4,000 | |
Purchases of property and equipment in accounts payable or accrued expenses | 5 | |
Preferred stock dividends | 77 | 18 |
Conversion of preferred stock into common stock | $ 4,257 |
Overview and Basis of Presentat
Overview and Basis of Presentation | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Overview and Basis of Presentation | 1. Overview and Basis of Presentation Overview Harvard Apparatus Regenerative Technology, Inc., formerly Biostage, Inc., (HRGN or the Company) is a clinical-stage biotechnology company focused on the development of regenerative medicine treatments for disorders of the gastro-intestinal system and other organs that result from cancer, trauma or birth defects. The Company’s technology is based on our proprietary cell-therapy platform that uses a patient’s own stem cells to regenerate and restore function to damaged organs. The Company believes that its technology represents a next generation solution for restoring organ function because it allows the patient to regenerate their own organ, thus eliminating the need for human donor or animal transplants, the sacrificing of another of the patient’s own organs or permanent artificial implants. Since inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, and acquiring operating assets. The Company has two business segments and does not have significant costs or assets outside the United States. On October 31, 2013, Harvard Bioscience, Inc., or Harvard Bioscience, contributed its regenerative medicine business assets, plus $ 15 The Company filed an amendment (the “Certificate of Amendment”) to its Amended and Restated Certificate of Incorporation (the “Certificate of Incorporation”) with the Secretary of State for the State of Delaware to change its name from Biostage, Inc. to Harvard Apparatus Regenerative Technology, Inc. The Company also amended and restated its Amended and Restated Bylaws, solely to reflect the name change (as amended, the “Third Amended and Restated Bylaws”). The Certificate of Amendment and the Third Amended and Restated Bylaws each became effective on July 20, 2023. In connection with the name change, the Company will trade on the OTCQB under the new ticker symbol “HRGN”. The new ticker symbol was effective at the open of the market on July 20, 2023. Consumer Health In the second quarter of 2023, the Company’s subsidiary in Hong Kong, Harvard Apparatus Regenerative Technology Limited, or HRGN LTD, started a Consumer Health business. The Consumer Health business will include a broad range of products focused on anti-aging dietary supplements. The Company plans to start selling anti-aging supplements through HRGN LTD in the third quarter of 2023. These products are marketed to the general public and initially targeted at consumers in the Great China Region through eCommerce (online sales). Going Concern The Company has incurred substantial operating losses since its inception, and as of June 30, 2023 had an accumulated deficit of approximately $ 88.5 4.7 The Company will need to raise additional funds to fund its operations. In the event the Company is unable to raise additional capital from outside sources before or during the first quarter of 2024, it may be forced to curtail or cease its operations. Cash requirements and cash resource needs will vary significantly depending upon the timing of the financial and other resource needs that will be required to complete ongoing development, pre-clinical and clinical testing of product candidates, as well as regulatory efforts and collaborative arrangements necessary for the Company’s product candidates that are currently under development. The Company is currently seeking and will continue to seek financing from other existing and/or new investors to raise necessary funds through a combination of public or private equity offerings. The Company may also pursue debt financings, other financing mechanisms, research grants, or strategic collaborations and licensing arrangements. The Company may not be able to obtain additional financing on favorable terms, if at all. The Company’s operations will be adversely affected if it is unable to raise or obtain needed funding and may materially affect the Company’s ability to continue as a going concern. The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern and therefore, the condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amount and classifications of liabilities that may result from the outcome of this uncertainty. |
Summary of Significant Accounti
Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements | 2. Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements Summary of Significant Accounting Policies The accounting policies underlying the accompanying unaudited condensed consolidated financial statements are those set forth in Note 2 to the consolidated financial statements for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K. Principles of Consolidation The condensed consolidated financial statements include the accounts of HRGN and its subsidiaries, Harvard Apparatus Regenerative Technology Limited (Hong Kong), Harvard Apparatus Regenerative Technology (Hangzhou) Limited (China), Harvard Apparatus Regenerative Technology GmbH (Germany) and HRGN Limited (UK). The functional currency for HRGN and these subsidiaries is the U.S dollar. All intercompany balances and transactions have been eliminated in consolidation. Basis of Presentation The condensed consolidated financial statements reflect the Company’s financial position, results of operations and cash flows in conformity with accounting principles generally accepted in the United States, or U.S. GAAP. Use of Estimates The process of preparing condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Such estimates include, but are not limited to, share-based compensation, valuation of warrant liability, accrued expenses and the valuation allowance for deferred income taxes. Actual results could differ from those estimates. Cash Concentrations The Company maintains its cash balances with a financial institution in federally insured accounts and may periodically have cash balances in excess of insurance limits. The Company maintains its accounts with financial institutions with a high credit rating. The Company has not experienced any losses to date and believes that it is not exposed to any significant credit risk on cash. Cash and Cash Equivalents The Company considers all highly liquid investments with a maturity of three months or less at the date of purchase to be cash equivalents. The Company currently invests available cash in money market funds. Property, Plant and Equipment Property, plant and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets as follows: Schedule of Property Plant and Equipment Estimated Useful Lives Leasehold improvements Shorter of expected useful life or lease term Furniture, machinery and equipment, computer equipment and software 3 7 Maintenance and repairs are charged to expense as incurred, while any additions or improvements are capitalized. Net Loss Per Share Basic net loss per share is calculated by dividing net loss applicable to common stockholders by the weighted-average number of shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted-average number of shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock method. For purposes of the diluted net loss per share calculation, warrants to purchase common stock and stock options are considered to be common stock equivalents, but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share applicable to common stockholders were the same for all periods presented. Unaudited Interim Financial Information The accompanying interim condensed consolidated balance sheet as of June 30, 2023, condensed consolidated interim statements of operations and stockholders’ equity (deficit) for the three and six months ended June 30, 2023 and 2022, and cash flows for the six months ended June 30, 2023 and 2022 are unaudited. The interim unaudited condensed consolidated financial statements have been prepared in accordance with GAAP on the same basis as the annual audited consolidated financial statements and, in the opinion of management, reflect all adjustments necessary for a fair statement of the Company’s financial position as of June 30, 2023, its condensed consolidated results of operations and stockholders’ equity (deficit) for the three and six months ended June 30, 2023 and 2022, and cash flows for the six months ended June 30, 2023 and 2022. The financial data and other information disclosed in these notes related to the three and six months ended June 30, 2023 and 2022 are unaudited. The results for the three and six months ended June 30, 2023 are not necessarily indicative of results to be expected for the year ending December 31, 2023, any other interim periods or any future year or period. Recently Adopted Accounting Pronouncements Accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s condensed consolidated financial statements upon adoption. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (ASU 2016-12) |
Fair Value Measurements and Sho
Fair Value Measurements and Short-term Investments | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements and Short-term Investments | 3. Fair Value Measurements and Short-term Investments Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The Company utilizes a valuation hierarchy for disclosure of the inputs to the valuations used to measure fair value that prioritizes the inputs into three broad levels. Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument. Level 3 inputs are unobservable inputs based on the Company’s own assumptions used to measure assets and liabilities at fair value. A financial asset or liability’s classification within the hierarchy is determined based on the lowest level input that is significant to the fair value measurement. The Company had no assets or liabilities classified as Level 2 or Level 3 as of June 30, 2023 and December 31, 2022. The Company’s short-term investments consist of a certificate of deposit account held to maturity and is carried at amortized cost. The carrying value of financial instruments (consisting of cash, accounts payable, accrued compensation and accrued expenses) is considered to be representative of their respective fair values due to the short-term nature of those instruments. The certificate of deposit matures in October 2023. The company has investments classified as short term and held-to-maturity on the accompanying condensed consolidated balance sheets. Investment income is included as other income. Investment income for the three months ended June 30, 2023 and June 30, 2022 consists primarily of interest earned of $ 41,000 0 41,000 0 The Company had approximately $ 2.1 2.5 1.2 0 Schedule of Short Term Investment Securities June 30, 2023 (In thousands) Amortized Held-to-maturity Certificate of deposit $ 2,523 Total investment securities $ 2,523 |
Accrued and Other Current Liabi
Accrued and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2023 | |
Payables and Accruals [Abstract] | |
Accrued and Other Current Liabilities | 4. Accrued and Other Current Liabilities Accrued and other current liabilities consist of the following: Schedule of Accrued and Other Current Liabilities June 30, December 31, 2023 2022 (in thousands) Research and development $ 923 $ — Advisory costs 375 300 Legal costs — 135 Audit services 70 80 Payroll 82 55 Other liabilities 26 12 Total accrued and other current liabilities $ 1,476 $ 582 |
Capital Stock
Capital Stock | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
Capital Stock | 5. Capital Stock Private Placement On April 12, 2023 and on March 31, 2023, the Company entered into Securities Purchase Agreements, each a Purchase Agreement, with new and existing investors, the Investors, pursuant to which the Investors agreed to purchase in a private placement an aggregate of 1,000,967 6 6.00 The Company had 1,113,622 4.69 |
Series E Convertible Preferred
Series E Convertible Preferred Stock | 6 Months Ended |
Jun. 30, 2023 | |
Series E Convertible Preferred Stock | |
Series E Convertible Preferred Stock | 6. Series E Convertible Preferred Stock On April 28, 2022, the Company entered into a Preferred Issuance Agreement, or PIA, with Harvard Bioscience, Inc., or HBIO, dated as of April 27, 2022. Pursuant to the PIA, the Company and HBIO agreed that once HBIO had paid at least $ 4.0 On June 10, 2022, following the execution of a subscription agreement and HBIO providing evidence of payment of the requisite $ 4.0 4,000 1,000 4.0 On January 18, 2023, HBIO converted 200 9,545 31,933 In connection with the private placement, as of April 12, 2023, the Company had received $ 6.0 4,000,000 6.00 674,693 There were no Schedule of Categories of Preferred Stock Authorized Undesignated preferred stock 979,000 Series B convertible preferred stock 1,000,000 Series C convertible preferred stock 4,000 Series D convertible preferred stock 12,000 Series E convertible preferred stock 5,000 |
Share-Based Compensation
Share-Based Compensation | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Compensation | 7. Share-Based Compensation HRGN Amended and Restated Equity Incentive Plan The Company maintains the Amended and Restated Equity Incentive Plan (the Plan) for the benefit of certain officers, employees, non-employee directors, and other key persons (including consultants and advisory board members). All options and awards granted under the Plan consist of the Company’s shares of common stock. The Company’s policy is to issue stock available from its registered but unissued stock pool through its transfer agent to satisfy stock option exercises and vesting of the restricted stock units. The vesting period for awards is generally four years ten years The Company’s Plan has 5,098,000 1,293,379 The following table summarizes information concerning options outstanding and exercisable: Schedule of Options Outstanding and Exercisable Amount Weighted-average exercise price Weighted-average contractual life (years) Aggregate intrinsic value (in thousands) Outstanding at December 31, 2022 2,516,924 $ 3.95 7.68 $ 6,917 Granted 1,863,309 6.05 Canceled / forfeited (593,333 ) 6.12 Outstanding at June 30, 2023 3,786,900 4.64 8.06 2,756 Options exercisable 1,998,552 4.65 7.44 1,971 Options vested and expected to vest 3,687,482 4.69 8.06 2,653 The Company’s outstanding stock options include 698,195 2.6 No Aggregate intrinsic value for outstanding options and exercisable options as of June 30, 2023, was approximately $ 2.8 2.0 3.65 4.4 2.69 The Company uses the Black-Scholes option pricing model to value its stock options. The weighted average assumptions for valuing options granted during the six months ended June 30, 2023 and 2022 were as follows: Schedule of Weighted Average Assumptions Six months ended June 30, 2023 2022 Risk-free interest rate 3.76 % 2.59 % Expected volatility 126.16 % 124.51 % Expected term (in years) 5.9 5.5 Expected dividend yield — % — % The Company recorded share-based compensation expense in the following expense categories of its condensed consolidated statements of operations: Schedule of Share-based Compensation Expense Three months ended Six months ended 2023 2022 2023 2022 (In thousands) (In thousands) Research and development $ 51 $ 88 $ 113 $ 148 Selling, general and administrative 428 189 2,206 364 Total $ 479 $ 277 $ 2,319 $ 512 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. Commitments and Contingencies On April 14, 2017, representatives for the estate of an individual plaintiff filed a wrongful death complaint with the Suffolk Superior Court, in the County of Suffolk, Massachusetts, against the Company and other defendants, including Harvard Bioscience, Inc., or HBIO, the former parent of the Company that spun off the Company in 2013, as well as another third party. The complaint sought payment for an unspecified amount of damages and alleged that the plaintiff sustained terminal injuries allegedly caused by products provided by certain of the named defendants and utilized in connection with surgeries performed by third parties in Europe in 2012 and 2013. This lawsuit related to the Company’s first-generation trachea scaffold technology for which the Company discontinued development in 2014, and not to the Company’s current HRGN Esophageal Implant. On April 27, 2022, the Company and HBIO executed a settlement with the plaintiffs (the “Settlement”), which resolves all claims relating to the litigation. The Settlement resulted in the dismissal with prejudice of the wrongful death claim, and neither the Company nor HBIO admit any fault or liability in connection with the claim. The Settlement also resolved any and all claims by and between the parties and the Company’s product liability insurance carriers, which resulted in the dismissal with prejudice of all claims asserted by or against those carriers, the Company and HBIO. In relation to the litigation, the Company paid approximately $ 5.9 100 0.1 With respect to such $ 5.9 4.0 4.0 8 4.0 4,000 8 1,000 4.0 3.3 0.8 From time to time, the Company may be involved in various claims and legal proceedings arising in the ordinary course of business. Other than the above matter, there are no such matters pending that the Company expects to be material in relation to its business, financial condition, results of operations, or cash flows. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2023 | |
Leases | |
Leases | 9. Leases The Company leases laboratory and office space and certain equipment with remaining terms ranging from 1 2 The laboratory and office space arrangement is under a sublease that was renewed in December of 2022 and currently extends through May 31, 2024. This lease automatically renews annually for one-year periods unless the Company or the counterparty provides a notice of termination within one hundred and eighty days prior to May 31 st On January 5, 2022, the Company executed a four-month sublease agreement for certain laboratory and office space at its Holliston, Massachusetts facility. The Company further extended the sublease agreement on a month-to-month basis until August 31, 2022 when the other party vacated the premises. For the six months ended June 30, 2022, the Company recorded sublease income of approximately $ 61,000 All of the Company’s leases qualify as operating leases. The following table summarizes the presentation of the Company’s operating leases in its condensed consolidated balance sheets: Schedule of Operating Leases in Consolidated Balance Sheets Balance Sheet Classification June 30, 2023 December 31, 2022 Assets: Operating lease assets Right-of-use asset, net $ 135 $ 147 Liabilities: Current portion of operating lease liabilities Current portion of operating lease liabilities 119 99 Operating lease liabilities, net of current portion Operating lease liabilities, net of current portion 18 48 Total operating lease liabilities $ 137 $ 147 The Company recorded operating lease expense in the following categories in its condensed consolidated statements of operations: Schedule of Operating Lease Expense Categories in Consolidated Statements of Operations Three months ended Six months ended 2023 2022 2023 2022 (In thousands) (In thousands) Research and development $ 17 $ 19 $ 35 $ 38 General and administrative 11 11 22 22 Total $ 28 $ 30 $ 57 $ 60 Cash paid included in the computation of the operating lease assets and lease liabilities during the three and six months ended June 30, 2023 amounted to approximately $ 28,000 57,000 30,000 60,000 The weighted average remaining lease term and weighted average discount rate of the Company’s operating leases are as follows: Schedule of Weighted Average Lease Term and Discount Rates As of June 30, 2023 2022 Remaining lease term (in years) 0.88 1.16 Discount rate 12.78 % 9.25 % The minimum lease payments for the next three years are expected to be as follows: Schedule of Minimum Lease Payments June 30, 2023 As of June 30, 2023 (in thousands) 2023 $ 70 2024 69 2025 5 Total lease payments 144 Less: imputed interest (7 ) Present value of operating lease liabilities $ 137 |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 10. Net Loss Per Share Schedule of Basic and Diluted Net Loss Per Share 2023 2022 2023 2022 Three months ended June 30, Six months ended June 30, 2023 2022 2023 2022 (in thousands, except shares and per share data) (in thousands, except shares and per share data) Net loss $ (2,614 ) $ (1,345 ) $ (5,504 ) $ (3,522 ) Preferred stock dividends 3 (18 ) (77 ) (18 ) Net loss attributable to common stockholders $ (2,611 ) $ (1,363 ) $ (5,581 ) $ (3,540 ) Basic and diluted weighted average common shares outstanding 13,785,657 11,230,525 13,000,211 10,996,996 Basic and diluted net loss per share attributable to common stockholders $ (0.19 ) $ (0.12 ) $ (0.43 ) $ (0.32 ) Basic net loss per share attributable to common stockholders $ (0.19 ) $ (0.12 ) $ (0.43 ) $ (0.32 ) The following potential common shares were excluded from the calculation of diluted net loss per share attributable to common stockholders for the six months ended June 30, 2023 and 2022 because including them would have had an anti-dilutive effect: Schedule of Antidilutive Securities Excluded from Computation of Earnings per Share Six months ended June 30, 2023 2022 Options to purchase common stock 3,786,900 2,402,603 Warrants to purchase common stock 1,113,622 1,888,622 Series E convertible preferred stock — 686,680 Total 4,900,522 4,977,905 |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 11. Income Taxes The Company did not record a federal or state income tax provision or benefit for the six months ended June 30, 2023 and 2022, respectively, due to the expected loss before income taxes to be incurred for the years ended December 31, 2023 and 2022, as well as the Company’s continued maintenance of a full valuation allowance against its net deferred tax assets. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 12. Subsequent Events The Company performed a review of events subsequent to the balance sheet through the date the financial statements were issued and determined that there were no such events requiring recognition or disclosure in the financial statements except as disclosed below. In July 2023, the Company’s shareholders approved the Amended and Restated Equity Incentive Plan to increase of the number of shares of the Company’s common stock available for issuance pursuant to the 2013 Equity Incentive Plan by 4,000,000 9,098,000 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The condensed consolidated financial statements include the accounts of HRGN and its subsidiaries, Harvard Apparatus Regenerative Technology Limited (Hong Kong), Harvard Apparatus Regenerative Technology (Hangzhou) Limited (China), Harvard Apparatus Regenerative Technology GmbH (Germany) and HRGN Limited (UK). The functional currency for HRGN and these subsidiaries is the U.S dollar. All intercompany balances and transactions have been eliminated in consolidation. |
Basis of Presentation | Basis of Presentation The condensed consolidated financial statements reflect the Company’s financial position, results of operations and cash flows in conformity with accounting principles generally accepted in the United States, or U.S. GAAP. |
Use of Estimates | Use of Estimates The process of preparing condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Such estimates include, but are not limited to, share-based compensation, valuation of warrant liability, accrued expenses and the valuation allowance for deferred income taxes. Actual results could differ from those estimates. |
Cash Concentrations | Cash Concentrations The Company maintains its cash balances with a financial institution in federally insured accounts and may periodically have cash balances in excess of insurance limits. The Company maintains its accounts with financial institutions with a high credit rating. The Company has not experienced any losses to date and believes that it is not exposed to any significant credit risk on cash. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with a maturity of three months or less at the date of purchase to be cash equivalents. The Company currently invests available cash in money market funds. |
Property, Plant and Equipment | Property, Plant and Equipment Property, plant and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets as follows: Schedule of Property Plant and Equipment Estimated Useful Lives Leasehold improvements Shorter of expected useful life or lease term Furniture, machinery and equipment, computer equipment and software 3 7 Maintenance and repairs are charged to expense as incurred, while any additions or improvements are capitalized. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing net loss applicable to common stockholders by the weighted-average number of shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted-average number of shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock method. For purposes of the diluted net loss per share calculation, warrants to purchase common stock and stock options are considered to be common stock equivalents, but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share applicable to common stockholders were the same for all periods presented. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The accompanying interim condensed consolidated balance sheet as of June 30, 2023, condensed consolidated interim statements of operations and stockholders’ equity (deficit) for the three and six months ended June 30, 2023 and 2022, and cash flows for the six months ended June 30, 2023 and 2022 are unaudited. The interim unaudited condensed consolidated financial statements have been prepared in accordance with GAAP on the same basis as the annual audited consolidated financial statements and, in the opinion of management, reflect all adjustments necessary for a fair statement of the Company’s financial position as of June 30, 2023, its condensed consolidated results of operations and stockholders’ equity (deficit) for the three and six months ended June 30, 2023 and 2022, and cash flows for the six months ended June 30, 2023 and 2022. The financial data and other information disclosed in these notes related to the three and six months ended June 30, 2023 and 2022 are unaudited. The results for the three and six months ended June 30, 2023 are not necessarily indicative of results to be expected for the year ending December 31, 2023, any other interim periods or any future year or period. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements Accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s condensed consolidated financial statements upon adoption. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (ASU 2016-12) |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Property Plant and Equipment Estimated Useful Lives | Property, plant and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets as follows: Schedule of Property Plant and Equipment Estimated Useful Lives Leasehold improvements Shorter of expected useful life or lease term Furniture, machinery and equipment, computer equipment and software 3 7 |
Fair Value Measurements and S_2
Fair Value Measurements and Short-term Investments (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Short Term Investment Securities | Schedule of Short Term Investment Securities June 30, 2023 (In thousands) Amortized Held-to-maturity Certificate of deposit $ 2,523 Total investment securities $ 2,523 |
Accrued and Other Current Lia_2
Accrued and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued and Other Current Liabilities | Accrued and other current liabilities consist of the following: Schedule of Accrued and Other Current Liabilities June 30, December 31, 2023 2022 (in thousands) Research and development $ 923 $ — Advisory costs 375 300 Legal costs — 135 Audit services 70 80 Payroll 82 55 Other liabilities 26 12 Total accrued and other current liabilities $ 1,476 $ 582 |
Series E Convertible Preferre_2
Series E Convertible Preferred Stock (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Series E Convertible Preferred Stock | |
Schedule of Categories of Preferred Stock | Schedule of Categories of Preferred Stock Authorized Undesignated preferred stock 979,000 Series B convertible preferred stock 1,000,000 Series C convertible preferred stock 4,000 Series D convertible preferred stock 12,000 Series E convertible preferred stock 5,000 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Options Outstanding and Exercisable | The following table summarizes information concerning options outstanding and exercisable: Schedule of Options Outstanding and Exercisable Amount Weighted-average exercise price Weighted-average contractual life (years) Aggregate intrinsic value (in thousands) Outstanding at December 31, 2022 2,516,924 $ 3.95 7.68 $ 6,917 Granted 1,863,309 6.05 Canceled / forfeited (593,333 ) 6.12 Outstanding at June 30, 2023 3,786,900 4.64 8.06 2,756 Options exercisable 1,998,552 4.65 7.44 1,971 Options vested and expected to vest 3,687,482 4.69 8.06 2,653 |
Schedule of Weighted Average Assumptions | The Company uses the Black-Scholes option pricing model to value its stock options. The weighted average assumptions for valuing options granted during the six months ended June 30, 2023 and 2022 were as follows: Schedule of Weighted Average Assumptions Six months ended June 30, 2023 2022 Risk-free interest rate 3.76 % 2.59 % Expected volatility 126.16 % 124.51 % Expected term (in years) 5.9 5.5 Expected dividend yield — % — % |
Schedule of Share-based Compensation Expense | The Company recorded share-based compensation expense in the following expense categories of its condensed consolidated statements of operations: Schedule of Share-based Compensation Expense Three months ended Six months ended 2023 2022 2023 2022 (In thousands) (In thousands) Research and development $ 51 $ 88 $ 113 $ 148 Selling, general and administrative 428 189 2,206 364 Total $ 479 $ 277 $ 2,319 $ 512 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Leases | |
Schedule of Operating Leases in Consolidated Balance Sheets | All of the Company’s leases qualify as operating leases. The following table summarizes the presentation of the Company’s operating leases in its condensed consolidated balance sheets: Schedule of Operating Leases in Consolidated Balance Sheets Balance Sheet Classification June 30, 2023 December 31, 2022 Assets: Operating lease assets Right-of-use asset, net $ 135 $ 147 Liabilities: Current portion of operating lease liabilities Current portion of operating lease liabilities 119 99 Operating lease liabilities, net of current portion Operating lease liabilities, net of current portion 18 48 Total operating lease liabilities $ 137 $ 147 |
Schedule of Operating Lease Expense Categories in Consolidated Statements of Operations | The Company recorded operating lease expense in the following categories in its condensed consolidated statements of operations: Schedule of Operating Lease Expense Categories in Consolidated Statements of Operations Three months ended Six months ended 2023 2022 2023 2022 (In thousands) (In thousands) Research and development $ 17 $ 19 $ 35 $ 38 General and administrative 11 11 22 22 Total $ 28 $ 30 $ 57 $ 60 |
Schedule of Weighted Average Lease Term and Discount Rates | The weighted average remaining lease term and weighted average discount rate of the Company’s operating leases are as follows: Schedule of Weighted Average Lease Term and Discount Rates As of June 30, 2023 2022 Remaining lease term (in years) 0.88 1.16 Discount rate 12.78 % 9.25 % |
Schedule of Minimum Lease Payments | The minimum lease payments for the next three years are expected to be as follows: Schedule of Minimum Lease Payments June 30, 2023 As of June 30, 2023 (in thousands) 2023 $ 70 2024 69 2025 5 Total lease payments 144 Less: imputed interest (7 ) Present value of operating lease liabilities $ 137 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Basic and Diluted Net Loss Per Share | Schedule of Basic and Diluted Net Loss Per Share 2023 2022 2023 2022 Three months ended June 30, Six months ended June 30, 2023 2022 2023 2022 (in thousands, except shares and per share data) (in thousands, except shares and per share data) Net loss $ (2,614 ) $ (1,345 ) $ (5,504 ) $ (3,522 ) Preferred stock dividends 3 (18 ) (77 ) (18 ) Net loss attributable to common stockholders $ (2,611 ) $ (1,363 ) $ (5,581 ) $ (3,540 ) Basic and diluted weighted average common shares outstanding 13,785,657 11,230,525 13,000,211 10,996,996 Basic and diluted net loss per share attributable to common stockholders $ (0.19 ) $ (0.12 ) $ (0.43 ) $ (0.32 ) Basic net loss per share attributable to common stockholders $ (0.19 ) $ (0.12 ) $ (0.43 ) $ (0.32 ) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings per Share | The following potential common shares were excluded from the calculation of diluted net loss per share attributable to common stockholders for the six months ended June 30, 2023 and 2022 because including them would have had an anti-dilutive effect: Schedule of Antidilutive Securities Excluded from Computation of Earnings per Share Six months ended June 30, 2023 2022 Options to purchase common stock 3,786,900 2,402,603 Warrants to purchase common stock 1,113,622 1,888,622 Series E convertible preferred stock — 686,680 Total 4,900,522 4,977,905 |
Overview and Basis of Present_2
Overview and Basis of Presentation (Details Narrative) - USD ($) $ in Thousands | Oct. 31, 2013 | Jun. 30, 2023 | Dec. 31, 2022 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Accumulated deficit | $ 88,515 | $ 83,011 | |
Short-term investments on hand | $ 4,700 | ||
Harvard Bioscience Plan [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Proceeds from contributions | $ 15,000 |
Schedule of Property Plant and
Schedule of Property Plant and Equipment Estimated Useful Lives (Details) | Jun. 30, 2023 |
Property, Plant and Equipment [Line Items] | |
Property, Plant, and Equipment, Useful Life, Term, Description [Extensible Enumeration] | Useful Life, Lease Term [Member] |
Minimum [Member] | Furniture Machinery And Equipment Computer Equipment And Software [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 3 years |
Maximum [Member] | Furniture Machinery And Equipment Computer Equipment And Software [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 7 years |
Schedule of Short Term Investme
Schedule of Short Term Investment Securities (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Cash and Cash Equivalents [Line Items] | ||
Total investment securities | $ 2,523 | |
Certificates of Deposit [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Total investment securities | $ 2,523 |
Fair Value Measurements and S_3
Fair Value Measurements and Short-term Investments (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |||||
Primarily of interest earned | $ 41,000 | $ 0 | $ 41,000 | $ 0 | |
Cash equivalents | 2,100,000 | 2,100,000 | $ 1,200,000 | ||
Short-term investments | $ 2,523,000 | $ 2,523,000 |
Schedule of Accrued and Other C
Schedule of Accrued and Other Current Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Research and development | $ 923 | |
Advisory costs | 375 | 300 |
Legal costs | 135 | |
Audit services | 70 | 80 |
Payroll | 82 | 55 |
Other liabilities | 26 | 12 |
Total accrued and other current liabilities | $ 1,476 | $ 582 |
Capital Stock (Details Narrativ
Capital Stock (Details Narrative) - Private Placement [Member] - USD ($) $ / shares in Units, $ in Millions | Apr. 12, 2023 | Mar. 31, 2023 | Jun. 30, 2023 |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||
Amount of consideration received from the transaction | $ 6 | $ 6 | |
Price per share | $ 6 | $ 6 | |
Common Stock [Member] | |||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||
Number of securities into which the class of warrant or right may be converted | 1,000,967 | 1,000,967 | |
Warrants to purchase common stock outstanding | 1,113,622 | ||
Weighted-average exercise price | $ 4.69 |
Schedule of Categories of Prefe
Schedule of Categories of Preferred Stock (Details) | Jun. 30, 2023 shares |
Undesignated Preferred Stock [Member] | |
Preferred stock, shares authorized | 979,000 |
Series B Preferred Stock [Member] | |
Preferred stock, shares authorized | 1,000,000 |
Series C Preferred Stock [Member] | |
Preferred stock, shares authorized | 4,000 |
Series D Preferred Stock [Member] | |
Preferred stock, shares authorized | 12,000 |
Series E Preferred Stock [Member] | |
Preferred stock, shares authorized | 5,000 |
Series E Convertible Preferre_3
Series E Convertible Preferred Stock (Details Narrative) - USD ($) | Apr. 12, 2023 | Jan. 18, 2023 | Jun. 10, 2022 | Apr. 28, 2022 | Jun. 30, 2023 |
Preferred stock, shares outstanding | 0 | ||||
Private Placement [Member] | |||||
Proceeds from private placement | $ 6,000,000 | ||||
Common Stock [Member] | |||||
Common stock dividends, shares | 31,933 | ||||
Series E Convertible Preferred Stock [Member] | |||||
Conversion of stock, shares issued | 200 | ||||
Accrued dividends | $ 9,545 | ||||
Series E Preferred Stock [Member] | |||||
Conversion of stock, shares issued | 674,693 | ||||
Conversion price, per share | $ 6 | ||||
Series E Preferred Stock [Member] | Private Placement [Member] | |||||
Proceeds from private placement | $ 4,000,000 | ||||
Harvard Bioscience Inc [Member] | Series E Convertible Preferred Stock [Member] | |||||
Litigation amount received | $ 4,000,000 | $ 4,000,000 | |||
Temporary equity, stock issued | 4,000 | ||||
Temporary equity, issue price per share | $ 1,000 |
Schedule of Options Outstanding
Schedule of Options Outstanding and Exercisable (Details) - Share-Based Payment Arrangement, Option [Member] - Biostage 2013 Equity Incentive Plan [Member] - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2023 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Amount, Outstanding | 2,516,924 | |
Weighted-average exercise price, Outstanding | $ 3.95 | |
Weighted-average contractual life, Outstanding | 8 years 21 days | 7 years 8 months 4 days |
Aggregate intrinsic value, Outstanding (in dollars) | $ 6,917 | |
Amount, Granted | 1,863,309 | |
Weighted-average exercise price, Granted | $ 6.05 | |
Amount, Canceled / forfeited | (593,333) | |
Weighted-average exercise price, Canceled / forfeited | $ 6.12 | |
Amount, Outstanding | 3,786,900 | 2,516,924 |
Weighted-average exercise price, Outstanding | $ 4.64 | $ 3.95 |
Aggregate intrinsic value, Outstanding (in dollars) | $ 2,756 | $ 6,917 |
Amount, Outstanding | 1,998,552 | |
Weighted-average exercise price, Options exercisable | $ 4.65 | |
Weighted-average contractual life, Options exercisable | 7 years 5 months 8 days | |
Aggregate intrinsic value, Options exercisable (in dollars) | $ 1,971 | |
Amount, Options vested and expected to vest | 3,687,482 | |
Weighted-average exercise price, Options vested and expected to vest | $ 4.69 | |
Weighted-average contractual life, Options vested and expected to vest | 8 years 21 days | |
Aggregate intrinsic value, Options vested and expected to vest (in dollars) | $ 2,653 |
Schedule of Weighted Average As
Schedule of Weighted Average Assumptions (Details) - Biostage 2013 Equity Incentive Plan [Member] | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Risk-free interest rate | 3.76% | 2.59% |
Expected volatility | 126.16% | 124.51% |
Expected term (years) | 5 years 10 months 24 days | 5 years 6 months |
Expected dividend yield | 0% | 0% |
Schedule of Share-based Compens
Schedule of Share-based Compensation Expense (Details) - Biostage 2013 Equity Incentive Plan [Member] - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total share-based compensation | $ 479 | $ 277 | $ 2,319 | $ 512 |
Research and Development Expense [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total share-based compensation | 51 | 88 | 113 | 148 |
Selling, General and Administrative Expenses [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total share-based compensation | $ 428 | $ 189 | $ 2,206 | $ 364 |
Share-Based Compensation (Detai
Share-Based Compensation (Details Narrative) | 6 Months Ended |
Jun. 30, 2023 USD ($) $ / shares shares | |
Performance Shares [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of award outstanding | shares | 698,195 |
Allocated share-based compensation expense | $ 2,600,000 |
Share based compensation arrangement by share based payment award unrecognized compensation costs | $ 0 |
HRGN Amended And Restate Equity Incentive Plan [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Share-based compensation arrangement by share-based payment award, award vesting period | 4 years |
Share-based compensation arrangement by share-based payment award, expiration period | 10 years |
Share-based compensation arrangement by share-based payment award, number of shares authorized | shares | 5,098,000 |
Common stock, capital shares reserved for future issuance | shares | 1,293,379 |
Share-based compensation arrangement by share-based payment award, options, outstanding, intrinsic value | $ 2,800,000 |
Share-based compensation arrangement by share-based payment award, options, exercisable, intrinsic value | $ 2,000,000 |
Share price | $ / shares | $ 3.65 |
Unrecognized compensation expense | $ 4,400,000 |
Employee service share-based compensation, nonvested awards, compensation cost not yet recognized, period for recognition | 2 years 8 months 8 days |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 6 Months Ended | |||
Jun. 10, 2022 | Mar. 03, 2022 | Jun. 30, 2022 | Jun. 30, 2023 | Dec. 31, 2022 | |
Loss Contingencies [Line Items] | |||||
Estimated litigation cost | $ 5.9 | $ 5.9 | |||
litigation paid percent | 100% | ||||
Harvard Bioscience Inc. [Member] | |||||
Loss Contingencies [Line Items] | |||||
Litigation amount received | $ 4 | $ 4 | |||
Harvard Bioscience Inc. [Member] | Convertible Preferred Stock [Member] | |||||
Loss Contingencies [Line Items] | |||||
Preferred stock, dividend rate, percentage | 8% | ||||
Harvard Bioscience Inc. [Member] | Series E 8% Convertible Preferred Stock [Member] | |||||
Loss Contingencies [Line Items] | |||||
Litigation amount received | $ 4 | ||||
Preferred stock, dividend rate, percentage | 8% | ||||
Temporary equity, stock issued | 4,000 | ||||
Temporary equity, issue price per share | $ 1,000 | ||||
Accrual for contingency matter | $ 3.3 | ||||
Legal costs on claims against insurance carrier | $ 0.8 | ||||
Medmarc [Member] | |||||
Loss Contingencies [Line Items] | |||||
Cash payment received on litigation | $ 0.1 |
Schedule of Operating Leases in
Schedule of Operating Leases in Consolidated Balance Sheets (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Leases | ||
Operating lease assets | $ 135 | $ 147 |
Current portion of operating lease liabilities | 119 | 99 |
Operating lease liabilities, net of current portion | 18 | 48 |
Total operating lease liabilities | $ 137 | $ 147 |
Schedule of Operating Lease Exp
Schedule of Operating Lease Expense Categories in Consolidated Statements of Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Operating lease expense | $ 28 | $ 30 | $ 57 | $ 60 |
Research and Development Expense [Member] | ||||
Operating lease expense | 17 | 19 | 35 | 38 |
Selling, General and Administrative Expenses [Member] | ||||
Operating lease expense | $ 11 | $ 11 | $ 22 | $ 22 |
Schedule of Weighted Average Le
Schedule of Weighted Average Lease Term and Discount Rates (Details) | Jun. 30, 2023 | Jun. 30, 2022 |
Leases | ||
Remaining lease term (in years) | 10 months 17 days | 1 year 1 month 28 days |
Discount rate | 12.78% | 9.25% |
Schedule of Minimum Lease Payme
Schedule of Minimum Lease Payments (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Leases | ||
2023 | $ 70 | |
2024 | 69 | |
2025 | 5 | |
Total lease payments | 144 | |
Less: imputed interest | (7) | |
Present value of operating lease liabilities | $ 137 | $ 147 |
Leases (Details Narrative)
Leases (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Sublease income | $ 32 | $ 61 | ||
Operating lease cost | $ 28 | $ 30 | $ 57 | $ 60 |
Minimum [Member] | ||||
Remaining term | 1 year | |||
Maximum [Member] | ||||
Remaining term | 2 years |
Schedule of Basic and Diluted N
Schedule of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Earnings Per Share [Abstract] | ||||
Net loss | $ (2,614) | $ (1,345) | $ (5,504) | $ (3,522) |
Preferred stock dividends | 3 | (18) | (77) | (18) |
Net loss attributable to common stockholders | $ (2,611) | $ (1,363) | $ (5,581) | $ (3,540) |
Weighted average number of shares outstanding basic | 13,785,657 | 11,230,525 | 13,000,211 | 10,996,996 |
Weighted average number of shares outstanding diluted | 13,785,657 | 11,230,525 | 13,000,211 | 10,996,996 |
Basic net loss per share attributable to common stockholders | $ (0.19) | $ (0.12) | $ (0.43) | $ (0.32) |
Diluted net loss per share attributable to common stockholders | $ (0.19) | $ (0.12) | $ (0.43) | $ (0.32) |
Schedule of Antidilutive Securi
Schedule of Antidilutive Securities Excluded from Computation of Earnings per Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 4,900,522 | 4,977,905 |
Share-Based Payment Arrangement, Option [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 3,786,900 | 2,402,603 |
Warrant [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 1,113,622 | 1,888,622 |
Series E Convertible Preferred Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 686,680 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - 2013 Equity Incentive Plan[ Member] | 1 Months Ended |
Jun. 30, 2023 shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Issuance of common stock | 4,000,000 |
Shares authorized | 9,098,000 |