Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Nov. 15, 2021 | |
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-35853 | |
Entity Registrant Name | BIOSTAGE, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 45-5210462 | |
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 | |
Title of 12(b) Security | None | |
No Trading Symbol Flag | true | |
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 | 10,688,407 | |
Entity Central Index Key | 0001563665 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash | $ 1,995 | $ 1,026 |
Restricted cash | 50 | 50 |
Grant receivable | 0 | 77 |
Prepaid expenses and other current assets | 277 | 524 |
Total current assets | 2,322 | 1,677 |
Property, plant and equipment, net | 130 | 217 |
Right-of-use assets | 103 | 182 |
Total assets | 2,555 | 2,076 |
Current liabilities: | ||
Accounts payable | 112 | 31 |
Accrued and other current liabilities | 272 | 317 |
Current portion of notes payable | 0 | 284 |
Warrant liability | 31 | 17 |
Current portion of operating lease liability | 81 | 107 |
Total current liabilities | 496 | 756 |
Notes payable, net of current portion | 0 | 120 |
Operating lease liability, net of current portion | 22 | 75 |
Total liabilities | 518 | 951 |
Commitments and contingencies (Note 7) | ||
Stockholders' equity: | ||
Preferred stock, $0.01 par value; 2,000,000 shares authorized as of September 30, 2021 and December 31, 2020, no shares issued and outstanding | 0 | 0 |
Common stock, $0.01 par value; 60,000,000 shares authorized as of September 30, 2021 and December 31, 2020; 10,688,407 and 9,388,407 issued and outstanding at September 30, 2021 and December 31, 2020, respectively | 107 | 94 |
Additional paid-in capital | 72,995 | 69,991 |
Accumulated deficit | (71,065) | (68,960) |
Total stockholders' equity | 2,037 | 1,125 |
Total liabilities and stockholders' equity | $ 2,555 | $ 2,076 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 2,000,000 | 2,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
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 | 10,688,407 | 9,388,407 |
Common stock, shares outstanding | 10,688,407 | 9,388,407 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
CONSOLIDATED STATEMENTS OF OPERATIONS | ||||
Revenues | $ 0 | $ 0 | $ 0 | $ 0 |
Operating expenses: | ||||
Research and development | 250 | 548 | 1,023 | 1,727 |
General and administrative | 572 | 510 | 1,712 | 2,488 |
Total operating expenses | 822 | 1,058 | 2,735 | 4,215 |
Operating loss | (822) | (1,058) | (2,735) | (4,215) |
Other income (expense): | ||||
Forgiveness of notes payable | 0 | 0 | 408 | 0 |
Grant income | 0 | 370 | 165 | 370 |
Change in fair value of warrant liability | (27) | 28 | (14) | 6 |
Other income (expense), net | 0 | 0 | 71 | (2) |
Total other income (expense), net | (27) | 398 | 630 | 374 |
Net loss | $ (849) | $ (660) | $ (2,105) | $ (3,841) |
Basic net loss per share (in dollars per share) | $ (0.08) | $ (0.07) | $ (0.22) | $ (0.45) |
Diluted net loss per share (in dollars per share) | $ (0.08) | $ (0.07) | $ (0.22) | $ (0.45) |
Weighted-average common shares, basic | 10,014,494 | 8,855,465 | 9,614,781 | 8,593,810 |
Weighted-average common shares, diluted | 10,014,494 | 8,855,465 | 9,614,781 | 8,593,810 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Balance at Dec. 31, 2019 | $ 82 | $ 65,102 | $ (64,095) | $ 1,089 |
Balance (in shares) at Dec. 31, 2019 | 8,155,555 | |||
Net loss | $ 0 | 0 | (3,841) | (3,841) |
Share-based compensation expense | $ 0 | 1,004 | 0 | 1,004 |
Share-based compensation expense (in shares) | 37,974 | |||
Common stock withheld for taxes | $ 0 | (42) | 0 | (42) |
Common stock withheld for taxes (in shares) | (12,026) | |||
Issuance of common stock and warrants to purchase common stock | $ 2 | 1,056 | 0 | 1,058 |
Issuance of common stock and warrants to purchase common stock (in shares) | 276,027 | |||
Issuance of common stock from exercise of warrants | $ 10 | 2,731 | 0 | 2,741 |
Issuance of common stock from exercise of warrants (in shares) | 930,877 | |||
Balance at Sep. 30, 2020 | $ 94 | 69,851 | (67,936) | 2,009 |
Balance (in shares) at Sep. 30, 2020 | 9,388,407 | |||
Balance at Jun. 30, 2020 | $ 87 | 67,419 | (67,276) | 230 |
Balance (in shares) at Jun. 30, 2020 | 8,688,083 | |||
Net loss | $ 0 | 0 | (660) | (660) |
Share-based compensation expense | $ 0 | 151 | 0 | 151 |
Share-based compensation expense (in shares) | 0 | |||
Issuance of common stock and warrants to purchase common stock | $ 1 | 498 | 0 | 499 |
Issuance of common stock and warrants to purchase common stock (in shares) | 125,000 | |||
Issuance of common stock from exercise of warrants | $ 6 | 1,783 | 0 | 1,789 |
Issuance of common stock from exercise of warrants (in shares) | 575,324 | |||
Balance at Sep. 30, 2020 | $ 94 | 69,851 | (67,936) | 2,009 |
Balance (in shares) at Sep. 30, 2020 | 9,388,407 | |||
Balance at Dec. 31, 2020 | $ 94 | 69,991 | (68,960) | 1,125 |
Balance (in shares) at Dec. 31, 2020 | 9,388,407 | |||
Net loss | $ 0 | 0 | (2,105) | (2,105) |
Share-based compensation expense | $ 0 | 421 | 0 | 421 |
Share-based compensation expense (in shares) | 0 | |||
Issuance of common stock and warrants to purchase common stock | $ 13 | 2,583 | 0 | 2,596 |
Issuance of common stock and warrants to purchase common stock (in shares) | 1,300,000 | |||
Balance at Sep. 30, 2021 | $ 107 | 72,995 | (71,065) | 2,037 |
Balance (in shares) at Sep. 30, 2021 | 10,688,407 | |||
Balance at Jun. 30, 2021 | $ 97 | 70,847 | (70,216) | 728 |
Balance (in shares) at Jun. 30, 2021 | 9,688,407 | |||
Net loss | $ 0 | 0 | (849) | (849) |
Share-based compensation expense | $ 0 | 160 | 0 | 160 |
Share-based compensation expense (in shares) | 0 | |||
Issuance of common stock and warrants to purchase common stock | $ 10 | 1,988 | 0 | 1,998 |
Issuance of common stock and warrants to purchase common stock (in shares) | 1,000,000 | |||
Balance at Sep. 30, 2021 | $ 107 | $ 72,995 | $ (71,065) | $ 2,037 |
Balance (in shares) at Sep. 30, 2021 | 10,688,407 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (2,105) | $ (3,841) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Forgiveness of notes payable | (408) | 0 |
Share-based compensation expense | 421 | 1,004 |
Depreciation | 87 | 139 |
Change in fair value of warrant liability | 14 | (6) |
Changes in operating assets and liabilities: | ||
Grant receivable | 77 | (370) |
Prepaid expenses and other current assets | 247 | 270 |
Accounts payable | 81 | (170) |
Accrued and other current liabilities | (41) | (45) |
Net cash used in operating activities | (1,627) | (3,019) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Purchases of property, plant and equipment | 0 | (7) |
Net cash used in investing activities | 0 | (7) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Proceeds from issuance of common stock and warrants | 2,596 | 1,058 |
Proceeds from exercise of warrants | 0 | 2,741 |
Proceeds from notes payable | 0 | 404 |
Acquisition of common stock for tax withholding obligations | 0 | (42) |
Net cash provided by financing activities | 2,596 | 4,161 |
Net increase in cash and restricted cash | 969 | 1,135 |
Cash and restricted cash at beginning of period | 1,076 | 963 |
Cash and restricted cash at end of period | 2,045 | 2,098 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Issuance of vested stock | $ 0 | $ 42 |
Overview and Basis of Presentat
Overview and Basis of Presentation | 9 Months Ended |
Sep. 30, 2021 | |
Overview and Basis of Presentation | |
Overview and Basis of Presentation | 1. Overview and Basis of Presentation Overview Biostage, Inc. (Biostage or the Company) is a biotechnology company developing bioengineered organ implants based on the Company’s novel Cellspan TM TM mesenchymal stromal cells to form the Company’s Cellspan provide surgeons a new paradigm to address life-threatening conditions of the esophagus, bronchus, and trachea due to congenital abnormalities, diseases, infections and traumas On October 31, 2013, Harvard Bioscience, Inc. (Harvard Bioscience) contributed its regenerative medicine business assets, plus $15 million of cash, into Biostage (formerly “Harvard Apparatus Regenerative Technologies” at the time of spin-off.) On November 1, 2013, the spin-off of the Company from Harvard Bioscience was completed. On that date, the Company became an independent company that operates the regenerative medicine business previously owned by Harvard Bioscience. The spin-off was completed through the distribution of all the shares of common stock of Biostage to stockholders of Harvard Bioscience (the “Distribution”). The Company’s common stock is currently traded on the OTCQB Venture Market under the symbol “BSTG”. Going Concern The Company has incurred substantial operating losses since its inception, and as of September 30, 2021 has an accumulated deficit of approximately $71.1 million and will require additional financing to fund future operations. The Company expects that its operating cash on-hand as of September 30, 2021 of approximately $2.0 million, which includes cash proceeds of approximately $2.6 million received in May, June, and September of 2021 from existing investors, will enable it to fund its operating expenses and capital expenditure requirements into the second quarter of 2022. Therefore, these conditions raise substantial doubt about the Company’s ability to continue as a going concern. The Company will need to raise additional funds to fund its operations. In the event the Company does not raise additional capital from outside sources in the second quarter of 2022, 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 products, as well as regulatory efforts and collaborative arrangements necessary for the Company’s products that are currently under development. The Company is currently seeking and will continue to seek financings 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 such circumstance may materially affect the Company’s ability to continue as a going concern. The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern and therefore, the 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 | 9 Months Ended |
Sep. 30, 2021 | |
Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements | |
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 consolidated financial statements are those set forth in Note 2 to the consolidated financial statements for the year ended December 31, 2020 included in the Company’s Annual Report on Form 10-K. Principles of Consolidation The consolidated financial statements include the accounts of Biostage, and three wholly-owned subsidiaries, Harvard Apparatus Regenerative Technology Limited (Hong Kong), Harvard Apparatus Regenerative Technology GmbH (Germany) and Biostage Limited (UK). All intercompany balances and transactions have been eliminated in consolidation. The functional currency for Biostage and these subsidiaries is the U.S dollar. Basis of Presentation The 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 (GAAP). Use of Estimates The preparation of the Company’s consolidated financial statements requires the Company to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, expenses and related disclosures. On an ongoing basis the Company evaluates its estimates, judgments and methodologies. The Company bases its estimates on historical experience and on various other assumptions that the Company believes are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity and the amount of expenses. Actual results may differ from these estimates. Net Loss Per Share Basic net loss per share is computed using the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed using the sum of the weighted average number of common shares outstanding during the period and, if dilutive, the weighted average number of potential shares of common stock, including the assumed exercise of stock options, warrants, and the impact of unvested restricted stock. The Company applies the two-class method to calculate basic and diluted net loss per share attributable to common stockholders as its warrants to purchase common stock are participating securities. The two-class method is an earnings allocation formula that treats a participating security as having rights to earnings that otherwise would have been available to common stockholders. However, the two-class method does not impact the net loss per share of common stock as the Company has been in a net loss position and the warrant holders do not participate in losses. Basic and diluted shares outstanding are the same for each period presented as all common stock equivalents would be antidilutive due to the net losses incurred. Unaudited Interim Financial Information The accompanying interim consolidated balance sheet as of September 30, 2021, consolidated interim statements of operations and stockholders’ equity for the three and nine months ended September 30, 2021 and 2020, and consolidated statements of cash flows for the nine months ended September 30, 2021 and 2020 are unaudited. The interim unaudited 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 September 30, 2021, its consolidated results of operations and consolidated stockholders’ equity for the three and nine months ended September 30, 2021 and 2020 and consolidated statements of cash flows for the nine months ended September 30, 2021 and 2020. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2021 and 2020 are unaudited. The results for the three and nine months ended September 30, 2021 are not necessarily indicative of results to be expected for the year ending December 31, 2021, any other interim periods or any future year or period. SBIR Award Grant income is recognized when qualified research and development costs are incurred and recorded in other income (expense), net in the consolidated statements of operations. When evaluating grant revenue from the SBIR grant, the Company considered accounting requirements under the Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 606, Revenue From Contracts With Customers. The Company concluded that ASC 606 did not apply as there is no exchange of goods or services or an exchange of intellectual property between the parties; therefore, the Company presents grant income in other income. On October 26, 2018, the Company was awarded the Phase II Fast-Track SBIR grant from the Eunice Kennedy NICHD grant aggregating approximately $1.1 million to support development, testing, and translation to the clinic through September 2019 and represented years one and two of the Phase II portion of the award. On August 3, 2020, the Company was awarded a third year of the Phase II grant totaling approximately $0.5 million for support of development, testing, and translation to the clinic covering qualified expenses incurred from October 1, 2019 through September 30, 2020. In September of 2020, the Company filed and was granted a one year, no-cost extension for the Phase II grant period extending through September 30, 2021. For the nine months ended September 30, 2021 and 2020, the Company recognized approximately $165,000 and $370,000 of grant income, respectively, from Phase II of the SBIR grant. The aggregate SBIR grant to date provided a total award of approximately $1.8 million, of which, approximately $1.5 million has been recognized through September 30, 2021. The Phase II portion of the award expired effective September 30, 2021. Restricted Cash Restricted cash consists of $50,000 held as collateral for the Company’s credit card program as of September 30, 2021 and December 31, 2020. The Company’s consolidated statements of cash flows include restricted cash with cash when reconciling the beginning-of-period and end-of-period total amounts shown on such statements. A reconciliation of the cash and restricted cash reported within the balance sheet that sum to the total of the same amounts shown in the consolidated statements of cash flows is as follows: September 30, December 31, 2021 2020 (In thousands) Cash $ 1,995 $ 1,026 Restricted cash 50 50 Total cash and restricted cash as shown in the consolidated statements of cash flows $ 2,045 $ 1,076 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 consolidated financial statements upon adoption. |
Capital Stock
Capital Stock | 9 Months Ended |
Sep. 30, 2021 | |
Capital Stock | |
Capital Stock | 3. Capital Stock On September 1, 2021, the Company issued a total of 1,000,000 shares of its common stock and warrants to purchase 500,000 shares of common stock with an exercise price of $2.00 per share, at purchase price of $2.00 per unit. Each unit consisted of one share of common stock and a warrant to purchase one half of one share of common stock. The shares and warrants were sold to a group of investors for aggregate gross and net proceeds of approximately $2.0 million, of which, $1.4 million and $0.6 million was allocated to the common stock and warrants, respectively. The Company classified these warrants on its consolidated balance sheets as equity as the warrants do not have any redemption features nor a right to put for cash that is outside the control of the Company, and valued using the Black-Scholes model based on the following weighted average assumptions: Risk-free interest rate 0.78 % Expected volatility 121.43 % Expected term 5 years Expected dividend yield — Exercise price $ 2.00 Market value of common stock $ 3.00 On June 17, 2021, the Company issued a total of 300,000 shares of its common stock and warrants to purchase 150,000 shares of common stock with an exercise price of $2.00 per share, at a purchase price of $2.00 per unit. Each unit consisted of one share of common stock and a warrant to purchase one half of one share of common stock. The shares and warrants were sold to a group of investors for aggregate gross and net proceeds of approximately $0.6 million, of which, $0.4 million and $0.2 million was allocated to the common stock and warrants, respectively. The Company classified these warrants on its consolidated balance sheets as equity as the warrants do not have any redemption features nor a right to put for cash that is outside the control of the Company, and valued using the Black-Scholes model based on the following weighted average assumptions: Risk-free interest rate 0.87 % Expected volatility 118.01 % Expected term 5 years Expected dividend yield — Exercise price $ 2.00 Market value of common stock $ 1.21 During the nine months ended September 30, 2020, the Company issued a total of 151,027 and 125,000 shares of its common stock at purchase prices of $3.70 and $4.00 per share, respectively, and warrants to purchase 151,027 shares of common stock at an exercise price of $3.70 per share to a group of investors for aggregate gross and net proceeds of approximately $1.1 million, of which $1.0 million and $0.1 million was allocated to the common stock and warrants, respectively. The fair value of the warrants at issuance was $0.1 million. The Company classified these warrants on its consolidated balance sheets as equity, and valued using the Black-Scholes model based on the following weighted average assumptions: Risk-free interest rate 0.88 % Expected volatility 106.7 % Expected term 2 months Expected dividend yield — Exercise price $ 3.70 Market value of common stock $ 3.11 During the nine months ended September 30, 2020, the Company issued 516,877 shares of its common stock to a group of investors in connection with the exercise of 516,877 previously issued warrants at $3.70 per share for aggregate gross and net proceeds of approximately $1.9 million. In separate transaction during the same period, the Company issued 414,000 shares of its common stock to a group of investors in connection with the exercise of 414,000 previously issued warrants at $2.00 per share for aggregate gross and net proceeds of approximately $0.8 million. During the nine months ended September 30, 2020, the Company issued a total of 25,948 shares of its common stock to employees due to the vesting of restricted stock units and issuance of a common stock award. Warrant to purchase common stock activity for the nine months ended September 30, 2021 was as follows: Weighted-average Amount exercise price Outstanding at December 31, 2020 1,893,201 $ 6.44 Issued 650,000 2.00 Exercised — — Outstanding at September 30, 2021 2,543,201 $ 5.30 |
Notes Payable
Notes Payable | 9 Months Ended |
Sep. 30, 2021 | |
Notes Payable. | |
Notes Payable | 4. Notes Payable On May 4, 2020, the Company obtained a loan (Loan) from the Bank of America (Lender) in the aggregate amount of approximately $0.4 million, pursuant to the Paycheck Protection Plan (PPP), established as part of the CARES Act. The Loan is evidenced by a promissory note dated May 4, 2020 issued by the Company and will accrue interest at a fixed interest rate of 1% per annum from the funding date of May 4, 2020. Payments of principal and interest have been deferred since the funding under the original terms of the promissory note. However, the Loan and accrued interest may be forgivable at the conclusion of this period. Under the terms of the PPP, certain amounts of the Loan may be forgiven if they are used for qualifying expenses as described in the CARES Act. The terms of the promissory note, including eligibility and forgiveness, may be subject to additional requirements adopted by the SBA. Any unforgiven portion of the PPP loan, including principal and interest, will mature on May 4, 2022 and will be required to be payable monthly. The Note may be prepaid by the Company at any time prior to maturity with no prepayment penalties. The Company has accounted for the loan under FASB ASC 470, Debt In accordance with FASB ASC 470, Debt |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Measurements | |
Fair Value Measurements | 5. Fair Value Measurements 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 as of September 30, 2021 and December 31, 2020. The Company’s restricted cash that serves as collateral for the Company’s credit card program is held in a demand money market account and is measured at fair value based on quoted prices, which are Level 1 inputs. The Company classifies warrants to purchase common stock that are accounted for as liabilities as Level 3 liabilities, as discussed below. The Company's notes payable carrying value as of December 31, 2020 approximates fair value due to the relatively small amount of principal and the short duration of the note payable. The Company had no notes payable at September 30, 2021. See Note 4. The following fair value hierarchy tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis: Fair value measurement as of September 30, 2021 (In thousands) Level 1 Level 2 Level 3 Total Assets: Restricted cash $ 50 $ — $ — $ 50 Total $ 50 $ — $ — $ 50 Liabilities: Warrant liability $ — $ — $ 31 $ 31 Total $ — $ — $ 31 $ 31 Fair value measurement as of December 31, 2020 (In thousands) Level 1 Level 2 Level 3 Total Assets: Restricted cash $ 50 $ — $ — $ 50 Total $ 50 $ — $ — $ 50 Liabilities: Warrant liability $ — $ — $ 17 $ 17 Total $ — $ — $ 17 $ 17 The following table presents a reconciliation of the Company’s liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) for the nine months ended September 30, 2021: Warrant liability (In thousands) Balance at December 31, 2020 $ 17 Change in fair value upon re-measurement 14 Balance at September 30, 2021 $ 31 The Company has re-measured the warrant liability to estimated fair value at inception, prior to modification and at each reporting date using the Black-Scholes option pricing model with the following weighted average assumptions: September 30, December 31, 2021 2020 Risk-free interest rate 0.05 % 0.12 % Expected volatility 154.68 % 137.89 % Expected term (in years) 0.4 1.1 Expected dividend yield — — Exercise price $ 8.00 $ 8.00 Market value of common stock $ 3.00 $ 1.25 Warrants to purchase shares of common stock 92,212 92,212 |
Share-Based Compensation
Share-Based Compensation | 9 Months Ended |
Sep. 30, 2021 | |
Share-Based Compensation | |
Share-Based Compensation | 6. Share-Based Compensation Biostage 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 and the contractual life is ten years. Canceled and forfeited options and awards are available to be reissued under the Plan. In June 2020, the Company’s shareholders approved the Plan, to among other things, increase of the number of shares of the Company’s common stock available for issuance pursuant to the 2013 Equity Incentive Plan by 3,000,000 shares, which increased the total shares authorized to be issued under the Plan to 5,098,000. There were 3,574,042 shares available for issuance as of September 30, 2021. The Company has granted options to purchase common stock under the Plan. Stock option activity during the nine months ended September 30, 2021 was as follows: Weighted-average Aggregate Number of Weighted – remaining intrinsic Options average contractual value (in Outstanding exercise price term (years) thousands) Outstanding at December 31, 2020 1,599,720 $ 6.33 5.77 $ — Granted 301,674 $ 1.49 Canceled (398,212) $ 9.20 Outstanding at September 30, 2021 1,503,182 $ 4.63 7.41 $ 876 Vested at September 30, 2021 895,850 $ 6.21 6.97 $ 376 The Company’s outstanding options include 243,532 performance-based awards that have vesting provisions subject to the achievement of certain business milestones. As of September 30, 2021, no expense has been recognized for these unvested awards given that the milestone achievements for these awards have not yet been deemed probable for accounting purposes. Total unrecognized compensation expense for the remaining 243,532 performance-based awards is approximately $0.8 million. As of September 30, 2021, unrecognized compensation cost related to unvested non-performance-based awards amounted to $0.4 million, which will be recognized over a weighted-average period of 0.7 years. The Company uses the Black-Scholes option pricing model to value its stock options. The weighted average assumptions for valuing options granted during the nine months ended September 30, 2021 and 2020 were as follows: September 30, 2021 2020 Risk-free interest rate 0.89 % 0.71 % Expected volatility 116.86 % 109.66 % Expected term (years) 5.28 4.2 Expected dividend yield — — The Company recorded share-based compensation expense in the following expense categories of its consolidated statements of operations: Three months ended Nine months ended September 30, September 30, 2021 2020 2021 2020 (In thousands) (In thousands) Research and development $ 96 $ 73 $ 213 $ 234 General and administrative 64 78 208 770 Total share-based compensation $ 160 $ 151 $ 421 $ 1,004 During the nine months ended September 30, 2020, as part of the termination arrangement with the Company’s former chief executive officer, the Company modified certain options to purchase 236,970 shares of common stock, issued an 80,000 fully vested stock option grant, and accelerated the vesting of 3,300 restricted stock units resulting in recording $153,000, $70,000, and $4,000, respectively, of share-based compensation. In March 2020, the Company issued 35,000 common stock awards to an employee to be earned upon the achievement of certain milestones. Such milestones were achieved during the nine months ended September 30, 2020 and the Company issued 23,793 fully vested shares of common stock to the employee with 11,207 common shares withheld to cover taxes. The Company recognized share-based compensation of $140,000 for the nine months ended September 30, 2020. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies | |
Commitments and Contingencies | 7. 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 (the “Court”), against the Company and other defendants, including Harvard Bioscience, Inc. (“Harvard Bioscience”), our former parent entity prior to the spin-off of the Company in 2013, as well as another third party. The complaint seeks payment for an unspecified amount of damages and alleges that the plaintiff sustained terminal injuries allegedly caused by products, including one synthetic trachea scaffold and two bioreactors, 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 relates to the Company’s first-generation trachea scaffold technology for which the Company discontinued development in 2014, and not to the Company’s current Cellframe technology nor to its lead development Cellspan Esophageal Implant product candidate. On October 1, 2019, the Court entered an order granting plaintiffs’ motion to compel the defendants to produce discovery. Subsequently, the plaintiff filed a motion for sanctions against the Company on January 6, 2020 claiming failure to produce the required discovery. The Company’s counsel at the time, which had been selected for the case by its liability insurance carrier, never notified the Company of plaintiffs’ motion and never responded to plaintiff’ motion. As a result of the failure of the Company’s former counsel to respond, on January 29, 2020, the Court entered an order allowing plaintiffs’ sanctions against the Company and the other defendants, which establishes a sanction of admitted liability. In June 2021, the Company was informed of these 2019 and 2020 court actions by new defense counsel appointed by its liability insurance carrier. On June 9, 2021, the Company, together with the other defendants, filed a motion to vacate the Court’s order allowing plaintiff’s motion for sanctions, and following a hearing on such motion, on August 6, 2021 the Court issued a ruling in our favor, vacating the sanctions. This case will now proceed on the merits, which the Company will continue to oppose vigorously. On September 15, 2021, one of the Company’s product liability insurance carriers which had been providing a defense to the Company and Harvard Bioscience, notified each party that it was denying coverage under the applicable policy for the lawsuit and would no longer be providing a defense to each such company with respect thereto, or covering related legal expenses incurred after September 30, 2021. The insurance carrier also filed a corresponding complaint for declaratory judgment with the Court asking the Court to declare that said insurance carrier is not required to defend, indemnify or provide coverage to the Company and Harvard Bioscience with respect to the lawsuit described above. The Company believes the insurance carrier’s grounds for denying coverage are without merit and intends to vigorously defend against this complaint for declaratory judgment and the insurance carrier’s denial of the claim and related matters. There can be no assurance that the Company and the other defendants will prevail in the insurance coverage litigation. As such, it is unclear at this point if our product liability insurance coverage will reimburse the Company for all or any portion of any defense costs or damages if the Company were to lose the underlying case on the merits. While there can be no assurance that the Company and other defendants will prevail in the underlying case, the Company continues to believe that the plaintiff’s claims made in the lawsuit are without merit and will continue to vigorously defend against such claims. If the Company faces a trial on damages and lose on the merits, it does not know the exact amount of compensatory and, potentially, punitive damages that could be awarded, but the amounts could be substantial. Considering these factors, an estimate of potential liability cannot be made at this time. However, any potential loss on the merits, especially if not covered by the Company’s product liability insurance, would be likely to adversely impact its financial condition and may cause the Company to have to curtail or cease its operations. The Company is evaluating possible malpractice claims as one source of recovery but has not asserted such a claim and cannot provide assurance that such a claim would provide a recovery. Further, in accordance with a separation and distribution agreement between Harvard Bioscience and the Company relating to the spin-off, the Company would be required to indemnify Harvard Bioscience against losses that Harvard Bioscience may suffer as a result of this litigation. 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 | 9 Months Ended |
Sep. 30, 2021 | |
Leases | |
Leases | 8. Leases The Company leases laboratory and office space and certain equipment with remaining terms ranging approximately from 0.7 to 3.0 years. The laboratory and office space arrangement is under a sublease that was renewed in December of 2020 and currently extends through May 31, 2022. This lease automatically renews annually for a one-year period unless the Company or the counterparty provides a notice of termination within one hundred and eighty days prior to May 31 st All of the Company’s leases qualify as operating leases. The following table summarizes the presentation of the Company’s operating leases in its consolidated balance sheets: September 30, December 31, (In thousands) Balance sheet classification 2021 2020 Assets: Operating lease assets Right-of-use asset $ 103 $ 182 Liabilities: Current operating lease liabilities Current portion of operating lease liabilities 81 107 Non-current operating lease liabilities Operating lease liabilities, net of current portion 22 75 Total operating lease liabilities $ 103 $ 182 The Company recorded operating lease expense in the following categories in its consolidated statements of operations: Three months ended September 30, Nine months ended September 30, 2021 2020 2021 2020 (In thousands) (In thousands) Research and development $ 19 $ 19 $ 58 $ 58 General and administrative 11 11 33 33 Total operating lease expense $ 30 $ 30 $ 91 $ 91 Cash paid included in the computation of the operating lease assets and lease liability during the nine months ended September 30, 2021 and 2020 amounted to approximately $91,000 and $91,000, respectively. The weighted average remaining lease term and weighted average discount rate of the Company’s operating leases are as follows: As of September 30, 2021 2020 Remaining lease term (in years) 1.38 1.99 Discount rate 10.54 % 13.12 % The minimum lease payments for the next five years are expected to be as follows: As of (In thousands) September 30, 2021 $ 31 2022 62 2023 12 2024 7 2025 — Total lease payments 112 Less: imputed interest 9 Present value of operating lease liabilities $ 103 |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2021 | |
Net Loss Per Share | |
Net Loss Per Share | 9. Net Loss 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 September 30, 2020 and 2019 because including them would have had an anti-dilutive effect: Nine months ended September 30, 2021 2020 Warrants to purchase common stock 2,543,201 1,893,201 Options to purchase common stock 1,503,182 1,641,674 Total 4,046,383 3,534,875 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2021 | |
Income Taxes | |
Income Taxes | 10. Income Taxes The Company did not record a federal or state income tax provision or benefit for the three and nine months ended September 30, 2021 and 2020, respectively, due to the expected loss before income taxes to be incurred for the years ended December 31, 2021 and 2020, as well as the Company’s continued maintenance of a full valuation allowance against its net deferred tax assets. The Company maintains the Harvard Apparatus Regenerative Technology GmbH (Germany) subsidiary whereas in fiscal years 2013, 2014 and 2015 certain withholding taxes were paid to the German tax authorities. In June of 2021, the Company received a refund payment of approximately $71,000 for certain withholding taxes paid during those fiscal years. This amount has been recorded in other income (expense), net, for the nine months ended September 30, 2021 |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2021 | |
Subsequent Events | |
Subsequent Events | 11. Subsequent Events The Company has performed an evaluation of subsequent events through the time of filing this Quarterly Report on Form 10-Q with the Securities Exchange Commission and has determined that there are no such events to report. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements | |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of Biostage, and three wholly-owned subsidiaries, Harvard Apparatus Regenerative Technology Limited (Hong Kong), Harvard Apparatus Regenerative Technology GmbH (Germany) and Biostage Limited (UK). All intercompany balances and transactions have been eliminated in consolidation. The functional currency for Biostage and these subsidiaries is the U.S dollar. |
Basis of Presentation | Basis of Presentation The 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 (GAAP). |
Use of Estimates | Use of Estimates The preparation of the Company’s consolidated financial statements requires the Company to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, expenses and related disclosures. On an ongoing basis the Company evaluates its estimates, judgments and methodologies. The Company bases its estimates on historical experience and on various other assumptions that the Company believes are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity and the amount of expenses. Actual results may differ from these estimates. |
Net Loss per Share | Net Loss Per Share Basic net loss per share is computed using the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed using the sum of the weighted average number of common shares outstanding during the period and, if dilutive, the weighted average number of potential shares of common stock, including the assumed exercise of stock options, warrants, and the impact of unvested restricted stock. The Company applies the two-class method to calculate basic and diluted net loss per share attributable to common stockholders as its warrants to purchase common stock are participating securities. The two-class method is an earnings allocation formula that treats a participating security as having rights to earnings that otherwise would have been available to common stockholders. However, the two-class method does not impact the net loss per share of common stock as the Company has been in a net loss position and the warrant holders do not participate in losses. Basic and diluted shares outstanding are the same for each period presented as all common stock equivalents would be antidilutive due to the net losses incurred. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The accompanying interim consolidated balance sheet as of September 30, 2021, consolidated interim statements of operations and stockholders’ equity for the three and nine months ended September 30, 2021 and 2020, and consolidated statements of cash flows for the nine months ended September 30, 2021 and 2020 are unaudited. The interim unaudited 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 September 30, 2021, its consolidated results of operations and consolidated stockholders’ equity for the three and nine months ended September 30, 2021 and 2020 and consolidated statements of cash flows for the nine months ended September 30, 2021 and 2020. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2021 and 2020 are unaudited. The results for the three and nine months ended September 30, 2021 are not necessarily indicative of results to be expected for the year ending December 31, 2021, any other interim periods or any future year or period. |
SBIR Award | SBIR Award Grant income is recognized when qualified research and development costs are incurred and recorded in other income (expense), net in the consolidated statements of operations. When evaluating grant revenue from the SBIR grant, the Company considered accounting requirements under the Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 606, Revenue From Contracts With Customers. The Company concluded that ASC 606 did not apply as there is no exchange of goods or services or an exchange of intellectual property between the parties; therefore, the Company presents grant income in other income. On October 26, 2018, the Company was awarded the Phase II Fast-Track SBIR grant from the Eunice Kennedy NICHD grant aggregating approximately $1.1 million to support development, testing, and translation to the clinic through September 2019 and represented years one and two of the Phase II portion of the award. On August 3, 2020, the Company was awarded a third year of the Phase II grant totaling approximately $0.5 million for support of development, testing, and translation to the clinic covering qualified expenses incurred from October 1, 2019 through September 30, 2020. In September of 2020, the Company filed and was granted a one year, no-cost extension for the Phase II grant period extending through September 30, 2021. For the nine months ended September 30, 2021 and 2020, the Company recognized approximately $165,000 and $370,000 of grant income, respectively, from Phase II of the SBIR grant. The aggregate SBIR grant to date provided a total award of approximately $1.8 million, of which, approximately $1.5 million has been recognized through September 30, 2021. The Phase II portion of the award expired effective September 30, 2021. |
Restricted Cash | Restricted Cash Restricted cash consists of $50,000 held as collateral for the Company’s credit card program as of September 30, 2021 and December 31, 2020. The Company’s consolidated statements of cash flows include restricted cash with cash when reconciling the beginning-of-period and end-of-period total amounts shown on such statements. A reconciliation of the cash and restricted cash reported within the balance sheet that sum to the total of the same amounts shown in the consolidated statements of cash flows is as follows: September 30, December 31, 2021 2020 (In thousands) Cash $ 1,995 $ 1,026 Restricted cash 50 50 Total cash and restricted cash as shown in the consolidated statements of cash flows $ 2,045 $ 1,076 |
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 consolidated financial statements upon adoption. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements | |
Schedule of reconciliation of the cash and restricted cash reported within the balance sheet that sum to the total of the same amounts shown in the consolidated statements of cash flows | September 30, December 31, 2021 2020 (In thousands) Cash $ 1,995 $ 1,026 Restricted cash 50 50 Total cash and restricted cash as shown in the consolidated statements of cash flows $ 2,045 $ 1,076 |
Capital Stock (Tables)
Capital Stock (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Capital Stock | |
Schedule of Classification of warrants to equity | Risk-free interest rate 0.78 % Expected volatility 121.43 % Expected term 5 years Expected dividend yield — Exercise price $ 2.00 Market value of common stock $ 3.00 Risk-free interest rate 0.87 % Expected volatility 118.01 % Expected term 5 years Expected dividend yield — Exercise price $ 2.00 Market value of common stock $ 1.21 Risk-free interest rate 0.88 % Expected volatility 106.7 % Expected term 2 months Expected dividend yield — Exercise price $ 3.70 Market value of common stock $ 3.11 |
Schedule of warrant to purchase common stock | Weighted-average Amount exercise price Outstanding at December 31, 2020 1,893,201 $ 6.44 Issued 650,000 2.00 Exercised — — Outstanding at September 30, 2021 2,543,201 $ 5.30 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Measurements | |
Schedule of assets and liabilities measured at fair value on a recurring basis | The following fair value hierarchy tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis: Fair value measurement as of September 30, 2021 (In thousands) Level 1 Level 2 Level 3 Total Assets: Restricted cash $ 50 $ — $ — $ 50 Total $ 50 $ — $ — $ 50 Liabilities: Warrant liability $ — $ — $ 31 $ 31 Total $ — $ — $ 31 $ 31 Fair value measurement as of December 31, 2020 (In thousands) Level 1 Level 2 Level 3 Total Assets: Restricted cash $ 50 $ — $ — $ 50 Total $ 50 $ — $ — $ 50 Liabilities: Warrant liability $ — $ — $ 17 $ 17 Total $ — $ — $ 17 $ 17 |
Schedule of reconciliation company's liabilities at fair value on recurring basis | Warrant liability (In thousands) Balance at December 31, 2020 $ 17 Change in fair value upon re-measurement 14 Balance at September 30, 2021 $ 31 |
Schedule of weighted average assumptions | September 30, December 31, 2021 2020 Risk-free interest rate 0.05 % 0.12 % Expected volatility 154.68 % 137.89 % Expected term (in years) 0.4 1.1 Expected dividend yield — — Exercise price $ 8.00 $ 8.00 Market value of common stock $ 3.00 $ 1.25 Warrants to purchase shares of common stock 92,212 92,212 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Share-Based Compensation | |
Schedule of Stock option activity | The Company has granted options to purchase common stock under the Plan. Stock option activity during the nine months ended September 30, 2021 was as follows: Weighted-average Aggregate Number of Weighted – remaining intrinsic Options average contractual value (in Outstanding exercise price term (years) thousands) Outstanding at December 31, 2020 1,599,720 $ 6.33 5.77 $ — Granted 301,674 $ 1.49 Canceled (398,212) $ 9.20 Outstanding at September 30, 2021 1,503,182 $ 4.63 7.41 $ 876 Vested at September 30, 2021 895,850 $ 6.21 6.97 $ 376 |
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 nine months ended September 30, 2021 and 2020 were as follows: September 30, 2021 2020 Risk-free interest rate 0.89 % 0.71 % Expected volatility 116.86 % 109.66 % Expected term (years) 5.28 4.2 Expected dividend yield — — |
Schedule of share-based compensation expense | September 30, 2021 2020 Risk-free interest rate 0.89 % 0.71 % Expected volatility 116.86 % 109.66 % Expected term (years) 5.28 4.2 Expected dividend yield — — |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Leases | |
Summary of presentation of operating leases in consolidated balance sheets | September 30, December 31, (In thousands) Balance sheet classification 2021 2020 Assets: Operating lease assets Right-of-use asset $ 103 $ 182 Liabilities: Current operating lease liabilities Current portion of operating lease liabilities 81 107 Non-current operating lease liabilities Operating lease liabilities, net of current portion 22 75 Total operating lease liabilities $ 103 $ 182 |
Summary of presentation of operating leases in consolidated balance sheets | The Company recorded operating lease expense in the following categories in its consolidated statements of operations: Three months ended September 30, Nine months ended September 30, 2021 2020 2021 2020 (In thousands) (In thousands) Research and development $ 19 $ 19 $ 58 $ 58 General and administrative 11 11 33 33 Total operating lease expense $ 30 $ 30 $ 91 $ 91 |
Schedule of Weighted average discount rate and lease term | The weighted average remaining lease term and weighted average discount rate of the Company’s operating leases are as follows: As of September 30, 2021 2020 Remaining lease term (in years) 1.38 1.99 Discount rate 10.54 % 13.12 % |
Summary of minimum lease payments for the next five years and thereafter | The minimum lease payments for the next five years are expected to be as follows: As of (In thousands) September 30, 2021 $ 31 2022 62 2023 12 2024 7 2025 — Total lease payments 112 Less: imputed interest 9 Present value of operating lease liabilities $ 103 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Net Loss Per Share | |
Schedule of antidilutive securities excluded from computation of earnings per share | Nine months ended September 30, 2021 2020 Warrants to purchase common stock 2,543,201 1,893,201 Options to purchase common stock 1,503,182 1,641,674 Total 4,046,383 3,534,875 |
Overview and Basis of Present_2
Overview and Basis of Presentation (Details) $ in Thousands | 1 Months Ended | 9 Months Ended | |
Oct. 31, 2013USD ($) | Sep. 30, 2021USD ($) | Dec. 31, 2020USD ($) | |
Overview And Basis Of Presentation [Line Items] | |||
Number of business segment | 1 | ||
Retained Earnings (Accumulated Deficit) | $ (71,065) | $ (68,960) | |
Cash | 1,995 | $ 1,026 | |
Existing Investors | |||
Overview And Basis Of Presentation [Line Items] | |||
Cash proceeds received | $ 2,600 | ||
Harvard Bioscience Plan [Member] | |||
Overview And Basis Of Presentation [Line Items] | |||
Proceeds from Contributions from Parent | $ 15,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements - Additional Information (Details) | 9 Months Ended | ||||
Sep. 30, 2021USD ($)item | Sep. 30, 2020USD ($) | Dec. 31, 2020USD ($) | Aug. 03, 2020USD ($) | Oct. 26, 2018USD ($) | |
Basic And Diluted Earnings Per Share [Line Items] | |||||
Number Of Wholly Owned Subsidiaries | item | 3 | ||||
Recognized grants receivable | $ 1,500,000 | ||||
Restricted Cash | 50,000 | $ 50,000 | |||
Grants Receivable | 1,800,000 | ||||
Phase Two | |||||
Basic And Diluted Earnings Per Share [Line Items] | |||||
Grants Receivable in fiscal year | $ 500,000 | $ 1,100,000 | |||
Grant Income Recognized | $ 165,000 | $ 370,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements - Cash and restricted cash (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Dec. 31, 2019 |
Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements | ||||
Cash | $ 1,995 | $ 1,026 | ||
Restricted cash | 50 | 50 | ||
Total cash and restricted cash as shown in the consolidated statements of cash flows | $ 2,045 | $ 1,076 | $ 2,098 | $ 963 |
Capital Stock (Details)
Capital Stock (Details) - $ / shares | Sep. 01, 2021 | Jun. 17, 2021 | Sep. 30, 2020 |
Capital Stock | |||
Risk-free interest rate | 0.78% | 0.87% | 0.88% |
Expected volatility | 121.43% | 118.01% | 106.70% |
Expected term | 5 years | 5 years | 2 months |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Exercise price | $ 2 | $ 2 | $ 3.70 |
Market value of common stock | $ 3 | $ 1.21 | $ 3.11 |
Capital Stock - Additional Info
Capital Stock - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | Sep. 01, 2021 | Jun. 17, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Dec. 31, 2020 |
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 92,212 | 92,212 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 8 | $ 8 | |||
Stock Issued During Period, Shares, New Issues | 151,027 | ||||
Share Price | $ 3.70 | ||||
Fair value of the warrants at issuance | $ 0.1 | ||||
Private Placement | |||||
Gross and net proceeds from issuance | $ 2 | $ 0.6 | 1.1 | ||
Stock Issued During Period, Value, New Issues | $ 0.6 | $ 0.2 | $ 0.1 | ||
Restricted Stock | |||||
Stock Issued During Period, Shares, New Issues | 25,948 | ||||
Common Stock | |||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 500,000 | 150,000 | 151,027 | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2 | $ 2 | $ 3.70 | ||
Stock Issued During Period, Shares, New Issues | 1,000,000 | 300,000 | 125,000 | ||
Share Price | $ 2 | $ 2 | $ 4 | ||
Warrants and Rights Outstanding | $ 1.4 | $ 0.4 | $ 1 | ||
Warrant One | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 3.70 | ||||
Proceeds from Warrant Exercises | $ 1.9 | ||||
Stock Issued During Period, Shares, New Issues | 516,877 | ||||
Shares Issued As A Result Of Exercise Of Warrants | 516,877 | ||||
Warrant Two | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2 | ||||
Proceeds from Warrant Exercises | $ 0.8 | ||||
Stock Issued During Period, Shares, New Issues | 414,000 | ||||
Shares Issued As A Result Of Exercise Of Warrants | 414,000 |
Capital Stock - Warrant (Detail
Capital Stock - Warrant (Details) | 9 Months Ended |
Sep. 30, 2021$ / sharesshares | |
Capital Stock | |
Amount, Outstanding | shares | 1,893,201 |
Amount, Issued | shares | 650,000 |
Amount, Exercised | shares | 0 |
Amount, Outstanding | shares | 2,543,201 |
Weighted-average exercise price, Outstanding | $ / shares | $ 6.44 |
Weighted-average exercise price, Issued | $ / shares | 2 |
Weighted-average exercise price, Exercised | $ / shares | 0 |
Weighted-average exercise price, Outstanding | $ / shares | $ 5.30 |
Notes Payable (Details)
Notes Payable (Details) - USD ($) $ in Thousands | Dec. 18, 2020 | May 04, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 |
Debt Instrument [Line Items] | ||||||
Gain on forgiveness of notes payable | $ 0 | $ 0 | $ 408 | $ 0 | ||
Paycheck Protection Program loan | ||||||
Debt Instrument [Line Items] | ||||||
Proceeds from Issuance of Debt | $ 400 | $ 400 | ||||
Fixed interest rate | 1.00% |
Fair Value Measurements - Recon
Fair Value Measurements - Reconciliation of company liabilities (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Fair Value Measurements | |
Beginning Balance | $ 17 |
Change in fair value upon re-measurement | 14 |
Ending Balance | $ 31 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Assets: | ||
Total | $ 50 | $ 50 |
Liabilities: | ||
Total | 31 | 17 |
Liabilities classified | 31 | 17 |
Notes payable | 0 | |
Restricted cash [Member] | ||
Liabilities: | ||
Fair Value Transfers Between Level Hierarchies | 50 | 50 |
Warrant liability | ||
Liabilities: | ||
Fair Value Transfers Between Level Hierarchies | 31 | 17 |
Level 1 [Member] | ||
Assets: | ||
Total | 50 | 50 |
Level 1 [Member] | Restricted cash [Member] | ||
Liabilities: | ||
Fair Value Transfers Between Level Hierarchies | 50 | 50 |
Level 2 [Member] | ||
Assets: | ||
Assets classified | 0 | 0 |
Liabilities: | ||
Liabilities classified | 0 | 0 |
Level 3 [Member] | ||
Liabilities: | ||
Total | 31 | 17 |
Level 3 [Member] | Warrant liability | ||
Liabilities: | ||
Fair Value Transfers Between Level Hierarchies | $ 31 | $ 17 |
Fair Value Measurements - Weigh
Fair Value Measurements - Weighted average assumptions (Details) - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Exercise Price | $ 8 | $ 8 |
Market value of common stock | $ 3 | $ 1.25 |
Warrants to purchase shares of common stock | 92,212 | 92,212 |
Measurement Input, Risk Free Interest Rate [Member] | ||
Risk-free interest rate | 0.05% | 0.12% |
Measurement Input, Price Volatility [Member] | ||
Expected volatility | 154.68 | 137.89 |
Measurement Input, Expected Term [Member] | ||
Expected term (in years) | 4 months 24 days | 1 year 1 month 6 days |
Measurement Input, Expected Dividend Rate [Member] | ||
Expected dividend yield | 0.00% | 0.00% |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock option and restricted stock unit activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Amount, Outstanding | 1,893,201 | |
Amount, Granted | 650,000 | |
Amount, Outstanding | 2,543,201 | 1,893,201 |
Weighted-average exercise price, Outstanding | $ 6.44 | |
Weighted-average exercise price, Granted | 2 | |
Weighted-average exercise price, Outstanding | $ 5.30 | $ 6.44 |
Biostage2013 Equity Incentive Plan [Member] | Stock Options [Member] | ||
Amount, Outstanding | 1,599,720 | |
Amount, Granted | 301,674 | |
Amount, Canceled | (398,212) | |
Amount, Outstanding | 1,503,182 | 1,599,720 |
Amount, Options vested | 895,850 | |
Weighted-average exercise price, Outstanding | $ 6.33 | |
Weighted-average exercise price, Granted | 1.49 | |
Weighted-average exercise price, Canceled | 9.20 | |
Weighted-average exercise price, Outstanding | 4.63 | $ 6.33 |
Weighted-average exercise price, Options vested | $ 6.21 | |
Weighted-average contractual life, Outstanding | 7 years 4 months 28 days | 5 years 9 months 7 days |
Weighted-average contractual life, Options Vested | 6 years 11 months 19 days | |
Outstanding at the beginning (in dollars) | $ 0 | |
Outstanding at the end (in dollars) | 876 | $ 0 |
Vested at the end (in dollars) | $ 376 |
Share-Based Compensation - Weig
Share-Based Compensation - Weighted average assumptions (Details) | Sep. 01, 2021 | Jun. 17, 2021 | Sep. 30, 2021 | Sep. 30, 2020 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk-free interest rate | 0.78% | 0.87% | 0.88% | |
Expected volatility | 121.43% | 118.01% | 106.70% | |
Expected term (years) | 5 years | 5 years | 2 months | |
Expected dividend yield | 0.00% | 0.00% | 0.00% | |
Biostage2013 Equity Incentive Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk-free interest rate | 0.89% | 0.71% | ||
Expected volatility | 116.86% | 109.66% | ||
Expected term (years) | 5 years 3 months 10 days | 4 years 2 months 12 days | ||
Expected dividend yield | 0.00% | 0.00% |
Share-Based Compensation - Shar
Share-Based Compensation - Share-based compensation expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total share-based compensation | $ 70,000 | |||
Biostage2013 Equity Incentive Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total share-based compensation | $ 160 | $ 151 | $ 421 | 1,004 |
Research and development [Member] | Biostage2013 Equity Incentive Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total share-based compensation | 96 | 73 | 213 | 234 |
General and administrative [Member] | Biostage2013 Equity Incentive Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total share-based compensation | $ 64 | $ 78 | $ 208 | $ 770 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) - USD ($) | 1 Months Ended | 9 Months Ended | |||
Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Allocated Share-based Compensation Expense | $ 70,000,000 | ||||
Number of award outstanding | 2,543,201 | 1,893,201 | |||
Restricted Stock Units (RSUs) | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Allocated Share-based Compensation Expense | 4,000,000 | ||||
Performance Shares [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share Based Compensation Arrangement By Share Based Payment Award Unrecognized Compensation Costs | $ 0 | ||||
Allocated Share-based Compensation Expense | $ 800,000 | ||||
Number of award outstanding | 243,532 | ||||
Unrecognized compensation expense | $ 243,532 | ||||
Common Stock Awards [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Allocated Share-based Compensation Expense | $ 140,000 | ||||
Number of awards issued | 35,000 | 23,793 | |||
Number of fully vested shares withheld | 11,207 | ||||
Chief executive officer | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Allocated Share-based Compensation Expense | $ 153,000,000 | ||||
Number of fully vested stock options issued | 80,000 | ||||
Number of options to purchase common stock modified | 236,970 | ||||
Chief executive officer | Restricted Stock Units (RSUs) | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of awards whose vesting was accelerated | 3,300 | ||||
Biostage Amended and Restated Equity Incentive Plan | |||||
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 Additional Shares Authorized | 3,000,000 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 5,098,000 | ||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 8 months 12 days | ||||
Shares available for issuance | 3,574,042 | ||||
Unrecognized compensation expense | $ 400,000 |
Leases (Details)
Leases (Details) | 9 Months Ended |
Sep. 30, 2021 | |
Lessee, Lease, Description [Line Items] | |
Renewal term | 1 year |
Termination option | false |
Notice period for termination | 180 days |
Minimum | |
Lessee, Lease, Description [Line Items] | |
Remaining term | 8 months 12 days |
Maximum | |
Lessee, Lease, Description [Line Items] | |
Remaining term | 3 years |
Leases - Operating leases in co
Leases - Operating leases in consolidated balance sheets (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Leases | ||
Right-of-use asset | Operating lease assets | Operating lease assets |
Operating lease assets | $ 103 | $ 182 |
Current operating lease liabilities | $ 81 | $ 107 |
Current portion of operating lease liabilities | Current operating lease liabilities | Current operating lease liabilities |
Non-current operating lease liabilities | $ 22 | $ 75 |
Operating lease liabilities, net of current portion | Non-current operating lease liabilities | Non-current operating lease liabilities |
Total operating lease liabilities | $ 103 | $ 182 |
Leases - Operating lease expens
Leases - Operating lease expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Research and development | $ 250 | $ 548 | $ 1,023 | $ 1,727 |
General and administrative | 572 | 510 | 1,712 | 2,488 |
Assets Leased To Other [Member] | ||||
Research and development | 19 | 19 | 58 | 58 |
General and administrative | 11 | 11 | 33 | 33 |
Total operating lease expense | $ 30 | $ 30 | $ 91 | $ 91 |
Leases - Weighted average disco
Leases - Weighted average discount rate and lease term (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Leases | ||
Remaining lease term (in years) | 1 year 4 months 17 days | 1 year 11 months 26 days |
Discount rate | 10.54% | 13.12% |
Cash paid included in the computation of the operating lease assets and lease liability | $ 91,000 | $ 91,000 |
Leases - Minimum lease payments
Leases - Minimum lease payments (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Minimum lease payments for the next five years and thereafter | ||
2021 | $ 31 | |
2022 | 62 | |
2023 | 12 | |
2024 | 7 | |
Total lease payments | 112 | |
Less: imputed interest | 9 | |
Total operating lease liabilities | $ 103 | $ 182 |
Net loss Per Share - Anti-dilut
Net loss Per Share - Anti-dilutive shares (Details) - shares | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 4,046,383 | 3,534,875 |
Warrants to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 2,543,201 | 1,893,201 |
Options to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 1,503,182 | 1,641,674 |
Income Taxes (Details)
Income Taxes (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Income Taxes | |
Refund for withholding taxes paid | $ 71,000 |