Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | May 08, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | CBIO | |
Entity Registrant Name | Catalyst Biosciences, Inc. | |
Entity Central Index Key | 0001124105 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 37,759,825 | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity File Number | 000-51173 | |
Entity Tax Identification Number | 56-2020050 | |
Entity Address, Address Line One | 611 Gateway Blvd. | |
Entity Address, Address Line Two | Suite 120 | |
Entity Address, City or Town | South San Francisco | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94080 | |
City Area Code | 650 | |
Local Phone Number | 871-0761 | |
Entity Interactive Data Current | Yes | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Title of 12(b) Security | Common Stock |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 8,099 | $ 21,666 |
Accounts and other receivables | 5,000 | 5,000 |
Prepaid and other current assets | 915 | 1,540 |
Total current assets | 14,014 | 28,206 |
Other assets, noncurrent | 168 | 168 |
Right-of-use assets | 17 | 66 |
Property and equipment, net | 1 | 4 |
Total assets | 18,750 | 28,444 |
Current liabilities: | ||
Accounts payable | 16 | 194 |
Accrued compensation | 1,085 | 2,582 |
Other accrued liabilities | 743 | 1,452 |
Dividends payable | 7,558 | |
CVR derivative liability | 5,000 | 5,000 |
Operating lease liability | 38 | |
Total current liabilities | 6,844 | 16,824 |
CVR derivative liability, noncurrent | 4,550 | |
Total liabilities | 11,394 | 16,824 |
Commitments and Contingencies (Note 9) | ||
Stockholders’ deficit: | ||
Common stock, $0.001 par value, 100,000,000 shares authorized; 37,759,825 and 37,756,574 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively | 37 | 37 |
Additional paid-in capital | 384,686 | 389,210 |
Accumulated deficit | (410,676) | (410,936) |
Total stockholders’ deficit | (25,953) | (21,689) |
Total liabilities, redeemable convertible preferred stock and stockholders’ deficit | 18,750 | 28,444 |
Redeemable Convertible Preferred Stock | ||
Current liabilities: | ||
Redeemable convertible preferred stock, $0.001 par value, 123,418 shares authorized; 12,340 shares issued and outstanding at March 31, 2023 and December 31, 2022 | 33,309 | $ 33,309 |
GC Biopharma Corp | ||
Current assets: | ||
Long-term receivable from GCBP | $ 4,550 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 37,759,825 | 37,756,574 |
Common stock, shares outstanding | 37,759,825 | 37,756,574 |
Redeemable Convertible Preferred Stock | ||
Temporary equity,par value | $ 0.001 | $ 0.001 |
Temporary equity, shares authorized | 123,418 | 123,418 |
Temporary equity, shares outstanding | 12,340 | 12,340 |
Temporary equity, shares issued | 12,340 | 12,340 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating expenses (income): | ||
Research and development | $ 588,000 | $ 9,703,000 |
General and administrative | 3,970,000 | 4,994,000 |
Gain on disposal of assets, net | (4,736,000) | |
Total operating expenses (income) | (178,000) | 15,495,000 |
Income (loss) from operations | 178,000 | (14,701,000) |
Interest and other income, net | 96,000 | 165,000 |
Income (loss) before income taxes | 274,000 | (14,536,000) |
Income tax expenses | 14,000 | 0 |
Net income (loss) | $ 260,000 | $ (14,536,000) |
Net income (loss) per share attributable to common stockholders, basic | $ 0.01 | $ (0.46) |
Net income (loss) per share attributable to common stockholders, diluted | $ 0.01 | $ (0.46) |
Shares used to compute net income (loss) per share attributable to common stockholders, basic | 37,758,416 | 31,456,090 |
Shares used to compute net income (loss) per share attributable to common stockholders, diluted | 37,984,324 | 31,456,090 |
Cash dividends paid per common share | $ 0.24 | |
Contingent Value Rights Agreement | ||
Operating expenses (income): | ||
Cash dividends paid per common share | $ 0.01 | |
Collaboration | ||
Revenue: | ||
License and collaboration revenue | $ 794,000 | |
Cost of collaboration | ||
Operating expenses (income): | ||
Cost of license and collaboration | $ 798,000 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) (Unaudited) - USD ($) $ in Thousands | Total | Redeemable Convertible Preferred Stock | Common Stock | Additional Paid-In Capital | Accumulated Deficit |
Balance at Dec. 31, 2021 | $ 41,089 | $ 31 | $ 443,752 | $ (402,694) | |
Balance (in shares) at Dec. 31, 2021 | 31,409,707 | ||||
Stock-based compensation expense | 515 | 515 | |||
Stock-based compensation expense | 32,684 | ||||
Issuance of common stock from stock grants | 16 | 16 | |||
Issuance of common stock from stock grants, shares | 34,662 | ||||
Net income (loss) | (14,536) | (14,536) | |||
Balance at Mar. 31, 2022 | 27,084 | $ 31 | 444,283 | (417,230) | |
Balance (in shares) at Mar. 31, 2022 | 31,477,053 | ||||
Balance at Dec. 31, 2022 | (21,689) | $ 37 | 389,210 | (410,936) | |
Temporary equity, Balance (in shares) at Dec. 31, 2022 | 12,340 | ||||
Temporary equity, Balance at Dec. 31, 2022 | $ 33,309 | ||||
Balance (in shares) at Dec. 31, 2022 | 37,756,574 | ||||
Stock-based compensation expense | 210 | 210 | |||
Issuance of common stock from stock grants | 2 | 2 | |||
Issuance of common stock from stock grants, shares | 3,251 | ||||
CVR cash dividends paid related to GCBP Agreement ($0.01 per share) | (206) | (206) | |||
CVR derivative liability | (4,530) | (4,530) | |||
Net income (loss) | 260 | 260 | |||
Balance at Mar. 31, 2023 | $ (25,953) | $ 37 | $ 384,686 | $ (410,676) | |
Temporary Equity, Balance (in shares) at Mar. 31, 2023 | 12,340 | ||||
Temporary Equity, Balance at Mar. 31, 2023 | $ 33,309 | ||||
Balance (in shares) at Mar. 31, 2023 | 37,759,825 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) (Unaudited) (Parenthetical) - $ / shares | 3 Months Ended | ||
Mar. 08, 2023 | Jan. 12, 2023 | Mar. 31, 2023 | |
Cash dividends paid per common share | $ 0.24 | $ 0.24 | |
Contingent Value Rights Agreement | |||
Cash dividends paid per common share | $ 0.01 | $ 0.01 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating Activities | ||
Net income (loss) | $ 260 | $ (14,536) |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||
Stock-based compensation expense | 210 | 515 |
Depreciation and amortization | 3 | 113 |
Change in fair value of long-term receivables | (20) | |
Change in fair value of derivative liabilities | 20 | |
Bad debt expense | 200 | |
Net gain on disposal of assets | (4,736) | |
Changes in operating assets and liabilities: | ||
Accounts and other receivables | 1,054 | |
Prepaid and other current assets | 625 | 1,485 |
Accounts payable | (178) | (1,713) |
Accrued compensation and other accrued liabilities | (2,411) | 1,036 |
Operating lease liability and right-of-use asset | 11 | 26 |
Deferred revenue | (230) | |
Net cash flows used in operating activities | (6,216) | (12,050) |
Investing Activities | ||
Proceeds from maturities of short-term investments | 2,504 | |
Proceeds from the sale of legacy rare bleeding disorder program to GCBP | 1,000 | |
Payment of transaction costs in connection with the sale of legacy rare bleeding disorder program to GCBP | (589) | |
Net cash flows provided by investing activities | 411 | 2,504 |
Financing Activities | ||
Payment of dividends | (7,764) | |
Issuance of common stock from stock grants | 2 | 16 |
Net cash flows (used in) provided by financing activities | (7,762) | 16 |
Net decrease in cash and cash equivalents | (13,567) | (9,530) |
Cash and cash equivalents at beginning of the period | 21,666 | 44,347 |
Cash and cash equivalents at end of the period | 8,099 | $ 34,817 |
Supplemental Disclosure on Non-Cash Investing and Financing Activities: | ||
CVR derivative liability | 4,530 | |
Accrued transaction costs related to GCBP asset sale | $ 205 |
Nature of Operations and Liquid
Nature of Operations and Liquidity | 3 Months Ended |
Mar. 31, 2023 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Nature of Operations and Liquidity | 1. Catalyst Biosciences, Inc. and its subsidiary (the “Company” or “Catalyst”) was a biopharmaceutical company with expertise in protease engineering. Prior to ceasing research and development activities in March 2022, the Company had several protease assets that were designed to address unmet medical needs in disorders of the complement or coagulation systems. As discussed further below, the Company recently completed a purchase agreement to acquire a clinical-stage drug candidate for the treatment of NASH (nonalcoholic steatohepatitis, a severe form of nonalcoholic fatty liver disease). Concurrent with this purchase agreement, the Company entered into a separate business combination agreement to acquire an indirect controlling interest in a China-based pharmaceutical company. The Company will continue to evaluate the impact of the novel coronavirus disease (“COVID-19”) pandemic on its business, operations, and cash requirements. On May 19, 2022, Catalyst entered into and closed on an asset purchase agreement with Vertex Pharmaceuticals Inc. (“Vertex”), pursuant to which Vertex acquired Catalyst’s complement portfolio, including CB 2782-PEG and CB 4332, as well as its complement-related intellectual property including the ProTUNE TM TM Restructuring. On February 27, 2023, Catalyst entered into and closed on an asset purchase agreement with GC Biopharma Corp. (“GCBP”), pursuant to which GCBP acquired Catalyst’s legacy rare bleeding disorder program, including the coagulation related assets marzeptacog alfa (activated) (“MarzAA”), dalcinonacog alfa (“DalcA”), and CB-2679d-GT. See Note 11, Restructuring. F351 Asset Acquisition On December 26, 2022, the Company executed and closed an Asset Purchase Agreement, which was amended on March 29, 2023 (the “F351 Agreement”), with GNI Group Ltd. and GNI Hong Kong Limited (together “GNI”) to purchase all of the assets and intellectual property rights primarily related to the proprietary Hydronidone compound (collectively, the “F351 Assets”), other than such assets and intellectual property rights located in the People’s Republic of China. At the closing of the agreement on December 26, 2022, the Company paid $35.0 million in the form of 6,266,521 shares of Catalyst common stock and 12,340 shares of newly designated Series X redeemable convertible preferred stock (“Catalyst Convertible Preferred Stock”). Each share of Catalyst Convertible Preferred Stock is convertible into 10,000 shares of common stock, subject to stockholder approval under Nasdaq rules and subject to a beneficial ownership conversion blocker. For additional information, see Note 3, F351 Asset Acquisition Business Combination Agreement Concurrent with the F351 Asset acquisition, the Company signed a definitive agreement, as amended on March 29, 2023, with GNI Group Ltd., GNI Hong Kong Limited, GNI USA, Inc., Continent Pharmaceuticals Inc. and Shanghai Genomics, Inc. (collectively, “GNI”) and other minority stockholders to acquire an indirect controlling interest in Beijing Continent Pharmaceutical Co Ltd. (“BC”), a commercial-stage pharmaceutical company based in China and majority-owned subsidiary of GNI, in exchange for newly issued shares of common stock (the “Business Combination Agreement”). The closing of the transactions under the Business Combination Agreement will be subject to stockholder approval at a stockholder meeting expected to be held in the third quarter of 2023 and certain customary closing conditions. For additional information, see Note 9, Commitments and Contingencies Contingent Value Rights Agreement Pursuant to the Business Combination Agreement, on December 26, 2022, Catalyst and the Rights Agent (as defined therein) executed a contingent value rights agreement, as amended on March 29, 2023 (the “CVR Agreement”), pursuant to which each holder of Catalyst common stock as of January 5, 2023 (the “CVR Holders”), excluding GNI, received one contractual contingent value right (a “CVR”) issued by the Company for each share of Catalyst common stock held by such holder. Each CVR entitles the holder thereof to receive certain cash payments in the future. For additional information, see Note 9, Commitments and Contingencies Liquidity On January 12, 2023, the Company paid a one-time cash dividend of $0.24 per share to the Company’s common stockholders of record as of close of business on January 5, 2023, excluding GNI. The aggregate amount of the special dividend payment was approximately $7.6 million. On March 8, 2023, the Company distributed the net cash proceeds received from the GCBP asset sale of $0.2 million, or $0.01 per share, to the CVR Holders, excluding GNI. See Note 11, Restructuring The Company had net income of $0.3 million for the three months ended March 31, 2023. As of March 31, 2023, the Company had an accumulated deficit of $410.7 million and cash and cash equivalents of $8.1 million. Its primary uses of cash are to fund operating expenses and general and administrative expenditures. As part of the F351 Agreement, the Company issued 12,340 shares of Catalyst Convertible Preferred Stock, which upon stockholder approval, will be converted to 123,400,000 shares of common stock, subject to applicable beneficial ownership limitations. The terms of the Catalyst Convertible Preferred Stock include a cash settlement feature which provide that, if the Company’s stockholders fail to approve the conversion of the Catalyst Convertible Preferred Stock by September 30, 2023, the Company could be required to make cash payments to the holders of Catalyst Convertible Preferred Stock significantly in excess of its current liquidity. The Company believes that stockholders who are entitled to vote on the conversion proposal at the Company’s 2023 Annual Meeting of Stockholders, which is expected to be held in the third quarter of 2023, will vote to approve the proposal. However, as the vote of the Company’s common stockholders is outside of the control of the Company, there is substantial doubt about its ability to continue as a going concern for at least 12 months following the issuance of these condensed consolidated financial statements. The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Basis of Presentation The Company’s condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and following the requirements of the Securities and Exchange Commission (the “SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP can be condensed or omitted. These financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments, which are necessary for a fair presentation of the Company’s financial information. These interim results and cash flows for any interim period are not necessarily indicative of the results to be expected for the year ending December 31, 2023, or for any other future annual or interim period. The accompanying condensed consolidated financial statements and related financial information should be read in conjunction with the consolidated financial statements filed with the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 (the “Annual Report”). Use of Estimates The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, allowance of doubtful accounts, long-term receivable, contingent value rights, operating lease right-of-use assets and liabilities, accrued expenses, income taxes and stock-based compensation. The Company bases its estimates on various assumptions that the Company believes to be reasonable under the circumstances. Actual results could differ from those estimates. Accounting Pronouncements Recently Adopted In June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments Long-Term Receivable The Company determined that the hold-back from the GCBP asset sale in February 2023 qualified as a long-term receivable. The receivable is considered a loan held for investment since the Company has the intent and ability to hold to maturity. Catalyst has elected to account for the receivable under the fair value option method of accounting and any changes in fair value are recorded in interest and other income, net on the condensed consolidated statement of operations . Refer to Note 4, Fair Value Measurements and Note 11, Restructuring , for additional information regarding the long-term receivable and GCBP asset sale. Net Income (Loss) per Share Attributable to Common Stockholders The Company calculates basic and diluted net income (loss) per share attributable to common stockholders in conformity with the two-class method required for participating securities. The Catalyst Convertible Preferred Stock contractually entitles the holders of such shares to participate in dividends but such participation is contingent upon the completion of the merger with GNI. As a result, the Catalyst Convertible Preferred Stock is excluded from the basic EPS calculation, as these shares are not participating securities until the merger with GNI closes. As such, net income for the periods presented was not allocated to these securities. During periods of loss, the Company allocates no loss to participating securities because they have no contractual obligation to share in the losses of the Company. Basic net income (loss) per share attributable to common stockholders is calculated by dividing the net income (loss) by the weighted average number of shares of common stock outstanding during the period, without consideration for potentially dilutive securities. Participating securities are excluded from the basic weighted average common shares outstanding. Diluted net income (loss) per share attributable to common stockholders is based on the weighted average number of common shares outstanding during the period, including potential dilutive common shares. For purposes of this calculation, outstanding stock options and warrants are considered potential dilutive common shares. The calculation of diluted EPS does not consider the effect of the Catalyst Convertible Preferred Stock since conversion is contingent upon the occurrence of a specified future event. |
F351 Asset Acquisition
F351 Asset Acquisition | 3 Months Ended |
Mar. 31, 2023 | |
Business Combinations [Abstract] | |
F351 Asset Acquisition | 3. F351 Asset Acquisition On December 26, 2022, the Company acquired the F351 Assets from GNI in accordance with the terms of the F351 Agreement as discussed in Note 1, Nature of Operations and Liquidity The Company concluded that the F351 acquisition was not the acquisition of a business, as substantially all of the fair value of the gross assets acquired was concentrated in a single identifiable asset, the intellectual property rights (outside of China) to a clinical stage drug candidate for the treatment of liver fibrosis, or the F351 Assets. Subject to stockholder approval, each share of Catalyst Convertible Preferred Stock issued under the F351 Agreement is convertible into 10,000 shares of common stock. The Company is required to hold a stockholders’ meeting to request the approval of the conversion of the Catalyst Convertible Preferred Stock into shares of common stock in accordance with Nasdaq Listing Rule 5635(a) (the “Conversion Proposal”). The Company expects to hold its 2023 Annual Meeting of Stockholders in the third quarter of 2023 and will include the following matters as proposals to be voted on at the meeting: (i) the Conversion Proposal and (ii) if necessary or appropriate, the approval of an amendment to the Company’s certificate of incorporation to authorize sufficient shares of common stock for the conversion of the Catalyst Convertible Preferred Stock issued pursuant to the F351 Agreement. In March 2023, the Company amended the F351 Agreement and the Catalyst Convertible Preferred Stock Certificate of Designation to extend the deadline for the cash settlement of the Catalyst Convertible Preferred Stock from June 26, 2023 to September 30, 2023. Under the amended terms, if the Company’s stockholders do not approve the conversion of the Catalyst Convertible Preferred Stock by September 30, 2023, then the Catalyst Convertible Preferred Stock would be redeemable at the option of the holders for cash equal to the closing price of the common stock on the last trading day prior to the holder’s redemption request. Using the closing price on May 8, 2023 of $0.21, if all the currently outstanding Catalyst Convertible Preferred Stock was redeemed for cash, the Company would be required to make a payment of approximately $25.9 million. The Company has insufficient liquidity to make such a payment, if required. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements For a description of the fair value hierarchy and the Company’s fair value methodology, see “ Part II - Item 8 - Financial Statements and Supplementary Data - Note 3 Summary of Significant Accounting Policies The following tables present the fair value hierarchy for assets and liabilities measured at fair value on a recurring basis as of March 31, 2023 and December 31, 2022 ( in thousands March 31, 2023 Level 1 Level 2 Level 3 Total Financial assets: Money market funds (1) $ 8,099 $ — $ — $ 8,099 Long-term receivable from GCBP — — 4,550 4,550 Total financial assets $ 8,099 $ — $ 4,550 $ 12,649 Financial liabilities: CVR derivative liability $ — $ — $ 5,000 $ 5,000 CVR derivative liability, noncurrent — — 4,550 4,550 Total financial liabilities $ — $ — $ 9,550 $ 9,550 December 31, 2022 Level 1 Level 2 Level 3 Total Financial assets: Money market funds (1) $ 21,666 $ — $ — $ 21,666 Total financial assets $ 21,666 $ — $ — $ 21,666 Financial liabilities: CVR derivative liability $ — $ — $ 5,000 $ 5,000 Total financial liabilities $ — $ — $ 5,000 $ 5,000 (1) Included in cash and cash equivalents on the accompanying condensed consolidated balance sheets The carrying amounts of accounts and other receivables, accounts payable, and accrued liabilities approximate their fair values due to the short-term maturity of these instruments. Derivative Liabilities and Long-term Receivables The CVR derivative liability relates to the CVR Agreement executed in connection with the Business Combination Agreement. The fair value of this derivative liability is based on significant unobservable inputs, which represent Level 3 measurements within the fair value hierarchy. The estimated fair value of the CVR liability was determined based on the anticipated amount and timing of projected cash flows to be received from Vertex pursuant to the Vertex asset purchase agreement. As of March 31, 2023, the Company expects to receive a $5.0 million hold-back payment from Vertex in the second quarter of 2023, which will be distributed, net of expenses, to the holders of Catalyst common stock as of January 5, 2023 under the CVR Agreement. The CVR liability was initially recorded at $5.0 million at issuance on December 26, 2022 and there was no change in the estimated fair value as of March 31, 2023. The long-term receivable and the corresponding CVR derivative liability, noncurrent relate to the asset purchase agreement with GCBP. The fair value of this long-term receivable and derivative liability is based on significant unobservable inputs, which represent Level 3 measurements within the fair value hierarchy. The estimated fair value of the long-term receivable and CVR derivative liability, noncurrent was determined based on the anticipated amount and timing of projected cash flows to be received from GCBP pursuant to the GCBP asset purchase agreement discounted to their present values using an estimated discount rate of 5.05%. As of March 31, 2023, the Company expects to receive a $5.0 million hold-back payment from GCBP in the first quarter of 2025, which will be distributed, net of expenses, to the holders of Catalyst common stock as of January 5, 2023 under the CVR Agreement. The following table sets forth the changes in the estimated fair value of the Company’s Level 3 financial assets and liabilities ( in thousands Long-term receivable CVR derivative from GCBP liability, noncurrent Balance at December 31, 2022 $ — $ — Additions in the period 4,530 4,530 Changes in fair value 20 20 Balance at March 31, 2023 $ 4,550 $ 4,550 |
Leases
Leases | 3 Months Ended |
Mar. 31, 2023 | |
Lessee Disclosure [Abstract] | |
Lease | 5 . Lease Operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term. In calculating the present value of the lease payments, the Company has elected to utilize its incremental borrowing rate based on the original lease term and not the remaining lease term. The lease includes non-lease components ( e.g. The Company leases office space for its corporate headquarters, located in South San Francisco, CA. The lease term is through April 30, 2023 and there are no stated renewal options. The Company currently has a month-to-month lease that will continue to be utilized following the expiration of the corporate headquarters lease. In March 2022, the Company entered into a sublease agreement for its leased facility that commenced in April 2022. Under the terms of the sublease agreement, the Company will receive $0.2 million in base lease payments over the term of the sublease, which ends in April 2023. For the three months ended March 31, 2023, the Company recognized sublease income of $38,000. The sublease agreement began in April 2022, so no sublease income was recognized during the three months ended March 31, 2022. For the three months ended March 31, 2023 and 2022, the Company’s operating lease expense was $0.1 million and $0.5 million, respectively. The Company has historically prepaid one month’s worth of rent expense, therefore as of March 31, 2023, the Company does not have any remaining lease payments under its current lease agreement. The present value assumptions used in calculating the present value of the lease payments were as follows: March 31, 2023 December 31, 2022 Weighted-average remaining lease term 0 years 0.3 years Weighted-average discount rate 0.0 % 4.3 % Supplemental cash flow information related to operating leases was as follows (in thousands) Three Months Ended March 31, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities $ 39 $ 502 |
Stock Based Compensation
Stock Based Compensation | 3 Months Ended |
Mar. 31, 2023 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock Based Compensation | 6 . Stock Based Compensation 2018 Omnibus Incentive Plan In June 2018, stockholders of the Company approved the Company’s 2018 Omnibus Incentive Plan (the “2018 Plan”). The 2018 Plan had previously been approved by the Company’s Board of Directors (the “Board”) and the Compensation Committee (the “Committee”) of the Board, subject to stockholder approval. The 2018 Plan became effective on June 13, 2018. On June 9, 2021, the stockholders of the Company approved an amendment previously approved by the Board to increase the number of shares of common stock reserved for issuance under the 2018 Plan by 2,500,000 to a total of 5,300,000 shares. The amendment became effective immediately upon stockholder approval. After the option modification (as discussed below), the number of shares of common stock reserved for issuance under the 2018 Plan increased to a total of 31,456,403. As of March 31, 2023, there were 25,521,867 shares of common stock available for future grant. Performance-Based Stock Option Grants In June 2022, the Committee approved the issuance of an option grant to purchase 400,000 shares (2,457,917 shares after the option modification discussed below) of common stock to the Chief Executive Officer pursuant to the 2018 Plan, which will vest upon (a) the achievement of a specified performance goal and (b) the grantee’s continued employment during the service period. During the three months ended March 31, 2023, this award was cancelled. Prior to cancellation, no expense has been recognized related to this award and no options have vested. Special Cash Dividend On January 12, 2023, the Company paid a special, one-time cash dividend of $7.6 million (or $0.24 per share) to the Company’s common stockholders of record as of the close of business on January 5, 2023. The Company determined, in accordance with the adjustment provision of the 2018 Plan, that the special cash dividend was unusual and non-recurring and that appropriate adjustment to the stock options to purchase shares of the Company’s common stock outstanding under the 2018 Plan was required. The Company treated this adjustment as a modification to the original stock option grants because the terms of the agreements were modified in order to preserve the value of the option awards after a large non-recurring cash dividend. These options were amended to decrease the exercise price and increase the number of shares subject to the stock option on a proportionate basis. No incremental value was provided to the option holders as a result of the modification and no additional compensation cost was recorded by the Company. The following table summarizes stock option activity under the Company’s 2018 Plan and related information: Number of Shares Underlying Outstanding Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (Years) Outstanding — December 31, 2022 8,678,767 $ 1.42 7.47 Options granted (1) 14,008,093 $ 0.86 Options forfeited and cancelled (1) (14,210,119 ) $ 0.91 Options expired (12,174 ) $ 36.16 Outstanding — March 31, 2023 8,464,567 $ 1.30 6.01 Exercisable — March 31, 2023 7,306,692 $ 1.40 (1) Includes options that were cancelled and re-granted as part of the option modification from the special cash dividend, as further discussed above. Valuation Assumptions The Company estimated the fair value of stock options granted using the Black-Scholes option-pricing formula and a single option award approach. Due to its limited relevant historical data, the Company estimated its volatility considering a number of factors including the use of the volatility of comparable public companies. The expected term of options granted under the Plan, all of which qualify as “plain vanilla” per SEC Staff Accounting Bulletin 107, is determined based on the simplified method due to the Company’s limited relevant history. The risk-free rate is based on the yield of a U.S. Treasury security with a term consistent with the option. This fair value is being amortized ratably over the requisite service periods of the awards, which is generally the vesting period. The only options granted during the quarter ended March 31, 2023 were as a result of the option modification. Since no new stock options were granted during the quarter ended March 31, 2023, all weighted-average assumptions for the period were not applicable. The fair value of employee stock options was estimated using the following weighted-average assumptions: Three Months Ended March 31, 2023 2022 Employee Stock Options: Risk-free interest rate — 1.87 % Expected term (in years) — 6.1 Dividend yield — — Volatility — 91.54 % Weighted-average fair value of stock options granted $ — $ 0.39 Total stock-based compensation expense recognized was as follows ( in thousands Three Months Ended March 31, 2023 2022 Research and development $ 66 $ 128 General and administrative (1) 144 387 Total stock-based compensation expense $ 210 $ 515 (1) No shares of common stock were issued to board members for the three months ended March 31, 2023. |
Collaborations
Collaborations | 3 Months Ended |
Mar. 31, 2023 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaborations | 7 . ISU Abxis In December 2018, the Company entered into an amended and restated license agreement with ISU Abxis (the “A&R ISU Abxis Agreement”). Under the A&R ISU Abxis Agreement, ISU Abxis will receive commercialization rights in South Korea to the Company’s engineered Factor IX dalcinonacog alfa - DalcA and the Company will receive clinical development and commercialization rights in the rest of world (excluding South Korea) and manufacturing development and manufacturing rights worldwide (including South Korea) The rovides for a low single-digit royalty payment to ISU Abxis, on a country-by-country basis, for net product sales of DalcA by the Company or its affiliates in each country other than South Korea. Pursuant to the A&R , the Company will also pay up to an aggregate of $19.5 million in milestone payments to ISU Abxis, including $2.5 million in regulatory and development milestone payments and up to $17.0 million in commercial milestone payments, if the applicable milestones are met. As a result of the sale of the Company’s rare bleeding disorders programs, including DalcA and other assets, to GCBP in February 2023, the A&R ISU Abxis Agreement was transferred to GCBP. See Note 11, Restructuring. |
Net Income (Loss) per Share Att
Net Income (Loss) per Share Attributable to Common Stockholders | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Income (Loss) per Share Attributable to Common Stockholders | 8 . Potentially dilutive securities are excluded from the calculation of diluted net income (loss) per share attributable to common stockholders if their inclusion is anti-dilutive. Potentially dilutive securities that were not included in the diluted per share calculations because they would be anti-dilutive were as follows: Three Months Ended March 31, 2023 2022 Options to purchase common stock 8,249,500 2,777,710 Common stock warrants — 85 Total 8,249,500 2,777,795 In addition, the Catalyst Convertible Preferred Stock has also been excluded from the computation of diluted net income (loss) per share attributable to common stockholders because the contingency for conversion of these shares has not been met. The following is a reconciliation of the numerator (net income or loss) and denominator (number of shares) used in the calculation of basic and diluted net income (loss) per share attributable to common stockholders (in thousands, except share and per share data): Three Months Ended March 31, 2023 2022 Numerator Net income (loss) $ 260 $ (14,536 ) Denominator Weighted-average number of shares used in computing net income (loss) per share available to common stockholders, basic 37,758,416 31,456,090 Effect of dilutive stock options 225,908 — Weighted-average number of shares used in computing net income (loss) per share available to common stockholders, diluted 37,984,324 31,456,090 Net income (loss) per share available for common stockholders, basic $ 0.01 $ (0.46 ) Net income (loss) per share available for common stockholders, dilutive $ 0.01 $ (0.46 ) |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9 . Commitments and Contingencies As of March 31, 2023 and December 31, 2022, the Company had cash deposited in certain financial institutions in excess of federally insured levels. The Company regularly monitors the financial stability of these financial institutions and believes that it is not exposed to any significant credit risk in cash and cash equivalents. However, in March and April 2023, certain U.S. government banking regulators took steps to intervene in the operations of certain financial institutions due to liquidity concerns, which caused general heightened uncertainties in financial markets. While these events have not had a material direct impact on the Company’s operations, if further liquidity and financial stability concerns arise with respect to banks and financial institutions, either nationally or in specific regions, the Company’s ability to access cash or enter into new financing arrangements may be threatened, which could have a material adverse effect on its business, financial condition and results of operations. Business Combination Agreement Concurrent with the F351 Asset acquisition, as amended on March 29, 2023, the Company entered into the Business Combination Agreement with GNI and other minority stockholders (“Sellers” and each a “Seller”) to acquire an indirect controlling interest in BC, a commercial-stage pharmaceutical company based in China and majority-owned subsidiary of GNI, in exchange for newly issued shares of Catalyst common stock. The closing of the transactions under the Business Combination Agreement will be subject to stockholder approval at a stockholder meeting expected to be held in the third quarter of 2023 and certain customary closing conditions. If the transaction is approved by stockholders, the Company would issue at closing a total of up to 1,110,776,224 shares of Catalyst common stock for an indirect controlling interest in BC. Each Seller may elect to be issued Catalyst Convertible Preferred Stock in lieu of the Company’s common stock. The Business Combination Agreement contains certain termination rights, including the right for Catalyst to terminate the Business Combination Agreement to enter into a definitive agreement for a superior proposal. Upon termination of the Business Combination Agreement under specified circumstances, the Company may be required to pay a termination fee of $2.0 million and either party, as the case may be, may be required to reimburse the other party for reasonable out-of-pocket fees and expenses incurred by such party in connection with the Business Combination Agreement, up to a maximum amount of $2.0 million. Contingent Value Rights Agreement Pursuant to the Business Combination Agreement, on December 26, 2022, Catalyst and the Rights Agent (as defined therein) executed the CVR Agreement, as amended on March 29, 2023, pursuant to which the CVR Holders received one contractual CVR issued by the Company, subject to and in accordance with the terms and conditions of the CVR Agreement, for each share of Catalyst common stock held by such holder. Each CVR entitles the holder thereof to receive (i) certain cash payments from the net proceeds related to the disposition of the Company’s legacy assets (MarzAA, DalcA, and CB 2679d-GT), (ii) 100% of the excess cash (net of all current or contingent liabilities, including transaction-related expenses) retained by the Company in excess of $1.0 million as of the closing date of the transactions under the Business Combination Agreement, (iii) 100% of the amount actually received by the Company, net of expenses, pursuant to the Vertex asset purchase agreement and (iv) 100% of the excess, by which the preapproved costs to manage, negotiate, settle and finalize certain third party claims exceed the costs actually incurred with respect to such claims. The CVRs are not transferable, except in certain limited circumstances as provided for in the CVR Agreement, will not be certificated or evidenced by any instrument, and will not be registered with the SEC or listed for trading on any exchange. In February 2023, the Company recorded a $4.5 million long-term CVR derivative liability as a result of the disposition of the Company’s legacy assets to GCBP. On March 8, 2023, the Company distributed the net cash proceeds received from the GCBP asset sale of $0.2 million to the CVR Holders. Refer to Note 4, Fair Value Measurements Restructuring, COVID-19 The current COVID-19 pandemic has presented a substantial public health and economic challenge around the world and is affecting the Company’s employees and business operations. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning COVID-19, the actions taken to contain it or treat its impact and the economic impact on local, regional, national, and international markets. The COVID-19 pandemic may disrupt the Company’s ability to conduct the clinical development and commercialization of Hydronidone in NASH fibrosis as planned. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 10 . Income Taxes During the three months ended March 31, 2023 and 2022, the Company recorded an income tax expense of $14,000 and zero, respectively. The Company recorded no income tax benefits for the net operating losses incurred or for the research and development tax credits generated in each period due to its uncertainty of realizing a benefit from those items. All of the Company’s operating losses since inception have been generated in the United States. As of March 31, 2023, after consideration of certain limitations (see below), the Company had approximately $194.1 million federal and $3.6 million state net operating loss carryforwards ("NOL") available to reduce future taxable income which, if unused, the majority will carry forward indefinitely for federal and will begin to expire in 2032 for state tax purposes. If the Company experiences a greater than 50 percent aggregate change in ownership over a three-year period (a Section 382 ownership change), utilization of its pre-change NOL carryforwards are subject to annual limitation under Section 382 of the Internal Revenue Code (California has similar provisions). The annual limitation is determined by multiplying the value of the Company's stock at the time of such ownership change by the applicable long-term tax-exempt rate. Such limitations may result in expiration of a portion of the NOL carryforwards before utilization. The Company determined that ownership changes occurred on December 31, 2007, August 20, 2015, April 13, 2017, February 15, 2018, February 18, 2020, and December 26, 2022. The ability of the Company to use its remaining NOL and tax credit carry forwards may be further limited if the Company experiences a Section 382 ownership change as a result of future changes in its stock ownership. |
Restructuring
Restructuring | 3 Months Ended |
Mar. 31, 2023 | |
Restructuring And Related Activities [Abstract] | |
Restructuring | 1 1 . Restructuring In November 2021, the Board approved a restructuring of its business based on its decision to stop the clinical development of MarzAA and focus solely on its complement programs and protease medicines platform. The restructuring included a reduction-in-force whereby approximately 35% of employees were terminated. In March 2022, the Board approved a further reduction of its workforce as part of its restructuring plan whereby 22 full-time employees were terminated. Following this reduction, the Company had five full-time employees remaining. During the quarter ended March 31, 2022, the Company recorded additional charges of $1.0 million for severance and other costs related to the reduction-in-force, recognized as an operating expense within the condensed consolidated statements of operations, which the Company paid during the second quarter of 2022. Sale of Assets In May 2022, the Company entered into an asset purchase agreement with Vertex, pursuant to which Vertex purchased the Company’s complement portfolio, including CB 2782-PEG and CB 4332, as well as its complement-related intellectual property including the ProTUNE TM TM Commitments and Contingencies In February 2023, Catalyst entered into an asset purchase agreement with GCBP, pursuant to which GCBP acquired the Company’s legacy rare bleeding disorders programs, including MarzAA, DalcA and CB-2679d-GT, for $6.0 million in cash consideration. Cash of $1.0 million was received upfront in February 2023 and the remaining $5.0 million will be paid two years after the closing upon satisfaction of certain post-closing indemnification obligations. The hold-back amount is recorded as a long-term receivable on the condensed consolidated balance sheet. In March 2023, the Company distributed the net cash proceeds received upfront of $0.2 million to the CVR Holders. Once received, the remaining net proceeds, net of expenses, from the hold-back amount will be distributed to the CVR Holders pursuant to the CVR Agreement, see Note 9, Commitments and Contingencies |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 1 2 . Subsequent Events Cost Sharing Agreement On April 13, 2023, the Company entered into a Cost Sharing and Agency Agreement with GNI. Under this agreement, GNI will pay for certain costs related to the development of the F351 Assets in the U.S. incurred from December 26, 2022 until the Business Combination Agreement closes. After the Business Combination Agreement closes, the Company will be required to reimburse GNI for such costs. The Company has not incurred any expenses related to the development of the F351 Assets through March 31, 2023. Manufacturing Agreements On April 18, 2023, the Company entered into two separate agreements to support the F351 Assets acquired from GNI. One agreement will cover analytical method process familiarization and validation to support good manufacturing practices (“GMP”) manufacturing, and the other agreement will cover non-GMP manufacturing services and clinical supply batch GMP manufacturing of the F351 Assets, with total payments of up to $0.3 million and $0.2 million, respectively. The Company can terminate these agreements at any time upon 90 days written notice. Upon termination, the Company will be responsible to pay for services incurred prior to termination and any non-cancellable obligations in connection with such services. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The Company’s condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and following the requirements of the Securities and Exchange Commission (the “SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP can be condensed or omitted. These financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments, which are necessary for a fair presentation of the Company’s financial information. These interim results and cash flows for any interim period are not necessarily indicative of the results to be expected for the year ending December 31, 2023, or for any other future annual or interim period. The accompanying condensed consolidated financial statements and related financial information should be read in conjunction with the consolidated financial statements filed with the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 (the “Annual Report”). |
Use of Estimates | Use of Estimates The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, allowance of doubtful accounts, long-term receivable, contingent value rights, operating lease right-of-use assets and liabilities, accrued expenses, income taxes and stock-based compensation. The Company bases its estimates on various assumptions that the Company believes to be reasonable under the circumstances. Actual results could differ from those estimates. |
Accounting Pronouncements Recently Adopted | Accounting Pronouncements Recently Adopted In June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments |
Long-Term Receivable | Long-Term Receivable The Company determined that the hold-back from the GCBP asset sale in February 2023 qualified as a long-term receivable. The receivable is considered a loan held for investment since the Company has the intent and ability to hold to maturity. Catalyst has elected to account for the receivable under the fair value option method of accounting and any changes in fair value are recorded in interest and other income, net on the condensed consolidated statement of operations . Refer to Note 4, Fair Value Measurements and Note 11, Restructuring , for additional information regarding the long-term receivable and GCBP asset sale. |
Net Income (Loss) per Share Attributable to Common Stockholders | Net Income (Loss) per Share Attributable to Common Stockholders The Company calculates basic and diluted net income (loss) per share attributable to common stockholders in conformity with the two-class method required for participating securities. The Catalyst Convertible Preferred Stock contractually entitles the holders of such shares to participate in dividends but such participation is contingent upon the completion of the merger with GNI. As a result, the Catalyst Convertible Preferred Stock is excluded from the basic EPS calculation, as these shares are not participating securities until the merger with GNI closes. As such, net income for the periods presented was not allocated to these securities. During periods of loss, the Company allocates no loss to participating securities because they have no contractual obligation to share in the losses of the Company. Basic net income (loss) per share attributable to common stockholders is calculated by dividing the net income (loss) by the weighted average number of shares of common stock outstanding during the period, without consideration for potentially dilutive securities. Participating securities are excluded from the basic weighted average common shares outstanding. Diluted net income (loss) per share attributable to common stockholders is based on the weighted average number of common shares outstanding during the period, including potential dilutive common shares. For purposes of this calculation, outstanding stock options and warrants are considered potential dilutive common shares. The calculation of diluted EPS does not consider the effect of the Catalyst Convertible Preferred Stock since conversion is contingent upon the occurrence of a specified future event. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Assets and Liabilities Measured at Fair Value on a Recurring Basis | The following tables present the fair value hierarchy for assets and liabilities measured at fair value on a recurring basis as of March 31, 2023 and December 31, 2022 ( in thousands March 31, 2023 Level 1 Level 2 Level 3 Total Financial assets: Money market funds (1) $ 8,099 $ — $ — $ 8,099 Long-term receivable from GCBP — — 4,550 4,550 Total financial assets $ 8,099 $ — $ 4,550 $ 12,649 Financial liabilities: CVR derivative liability $ — $ — $ 5,000 $ 5,000 CVR derivative liability, noncurrent — — 4,550 4,550 Total financial liabilities $ — $ — $ 9,550 $ 9,550 December 31, 2022 Level 1 Level 2 Level 3 Total Financial assets: Money market funds (1) $ 21,666 $ — $ — $ 21,666 Total financial assets $ 21,666 $ — $ — $ 21,666 Financial liabilities: CVR derivative liability $ — $ — $ 5,000 $ 5,000 Total financial liabilities $ — $ — $ 5,000 $ 5,000 (1) Included in cash and cash equivalents on the accompanying condensed consolidated balance sheets |
Changes in Estimated Fair Value of Level 3 Financial Assets and Liabilities | The following table sets forth the changes in the estimated fair value of the Company’s Level 3 financial assets and liabilities ( in thousands Long-term receivable CVR derivative from GCBP liability, noncurrent Balance at December 31, 2022 $ — $ — Additions in the period 4,530 4,530 Changes in fair value 20 20 Balance at March 31, 2023 $ 4,550 $ 4,550 |
Lease (Tables)
Lease (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Lessee Disclosure [Abstract] | |
Summary of Present Value Assumptions used in Calculating Present Value of Lease Payments | The present value assumptions used in calculating the present value of the lease payments were as follows: March 31, 2023 December 31, 2022 Weighted-average remaining lease term 0 years 0.3 years Weighted-average discount rate 0.0 % 4.3 % |
Schedule of Supplemental Cash Flow Information | Supplemental cash flow information related to operating leases was as follows (in thousands) Three Months Ended March 31, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities $ 39 $ 502 |
Stock Based Compensation (Table
Stock Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Option Activity Under Company's Equity Incentive Plans | The following table summarizes stock option activity under the Company’s 2018 Plan and related information: Number of Shares Underlying Outstanding Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (Years) Outstanding — December 31, 2022 8,678,767 $ 1.42 7.47 Options granted (1) 14,008,093 $ 0.86 Options forfeited and cancelled (1) (14,210,119 ) $ 0.91 Options expired (12,174 ) $ 36.16 Outstanding — March 31, 2023 8,464,567 $ 1.30 6.01 Exercisable — March 31, 2023 7,306,692 $ 1.40 (1) Includes options that were cancelled and re-granted as part of the option modification from the special cash dividend, as further discussed above. |
Summary of Weighted Average Valuation Assumptions Used to Estimate Fair Value of Employee Stock Options | The fair value of employee stock options was estimated using the following weighted-average assumptions: Three Months Ended March 31, 2023 2022 Employee Stock Options: Risk-free interest rate — 1.87 % Expected term (in years) — 6.1 Dividend yield — — Volatility — 91.54 % Weighted-average fair value of stock options granted $ — $ 0.39 |
Summary of Stock-Based Compensation Expense Recognized | Total stock-based compensation expense recognized was as follows ( in thousands Three Months Ended March 31, 2023 2022 Research and development $ 66 $ 128 General and administrative (1) 144 387 Total stock-based compensation expense $ 210 $ 515 (1) No shares of common stock were issued to board members for the three months ended March 31, 2023. |
Net Income (Loss) per Share A_2
Net Income (Loss) per Share Attributable to Common Stockholders (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Anti-dilutive Security not Included in Diluted per Share Calculations | Potentially dilutive securities that were not included in the diluted per share calculations because they would be anti-dilutive were as follows: Three Months Ended March 31, 2023 2022 Options to purchase common stock 8,249,500 2,777,710 Common stock warrants — 85 Total 8,249,500 2,777,795 |
Basic and Diluted Net Income (Loss) Per Share Attributable to Common Stockholders | The following is a reconciliation of the numerator (net income or loss) and denominator (number of shares) used in the calculation of basic and diluted net income (loss) per share attributable to common stockholders (in thousands, except share and per share data): Three Months Ended March 31, 2023 2022 Numerator Net income (loss) $ 260 $ (14,536 ) Denominator Weighted-average number of shares used in computing net income (loss) per share available to common stockholders, basic 37,758,416 31,456,090 Effect of dilutive stock options 225,908 — Weighted-average number of shares used in computing net income (loss) per share available to common stockholders, diluted 37,984,324 31,456,090 Net income (loss) per share available for common stockholders, basic $ 0.01 $ (0.46 ) Net income (loss) per share available for common stockholders, dilutive $ 0.01 $ (0.46 ) |
Nature of Operations and Liqu_2
Nature of Operations and Liquidity - Additional Information (Detail) $ / shares in Units, $ in Thousands | 3 Months Ended | |||||
Mar. 08, 2023 USD ($) $ / shares | Jan. 12, 2023 USD ($) $ / shares | Dec. 26, 2022 USD ($) shares | Mar. 31, 2023 USD ($) Segment $ / shares | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Organization and Nature of Operations [Line Items] | ||||||
Number of operating segment | Segment | 1 | |||||
Dividends Payable, date declared | Jan. 12, 2023 | |||||
Dividends paid | $ / shares | $ 0.24 | $ 0.24 | ||||
Amount of dividend payment | $ 7,600 | |||||
Common stock, dividend payable, date of record | Jan. 05, 2023 | |||||
Net income (loss) | $ 260 | $ (14,536) | ||||
Accumulated deficit | 410,676 | $ 410,936 | ||||
Cash and cash equivalents | $ 8,099 | $ 21,666 | ||||
F351 Agreement | ||||||
Organization and Nature of Operations [Line Items] | ||||||
Assets acquisition, paid | $ 35,000 | |||||
Purchase agreement amendment date | Mar. 29, 2023 | |||||
Business Combination Agreement | ||||||
Organization and Nature of Operations [Line Items] | ||||||
Purchase agreement amendment date | Mar. 29, 2023 | |||||
Contingent Value Rights Agreement | ||||||
Organization and Nature of Operations [Line Items] | ||||||
Purchase agreement amendment date | Mar. 29, 2023 | |||||
Dividends paid | $ / shares | $ 0.01 | $ 0.01 | ||||
Amount of dividend payment | $ 200 | |||||
Convertible Preferred Stock | F351 Agreement | ||||||
Organization and Nature of Operations [Line Items] | ||||||
Preferred stock shares issued | shares | 12,340 | |||||
Preferred stock, shares issued upon conversion of common stock | shares | 10,000 | |||||
Common Stock | F351 Agreement | ||||||
Organization and Nature of Operations [Line Items] | ||||||
Assets acquisition, shares issued | shares | 6,266,521 | |||||
Conversion of stock shares, issued | shares | 123,400,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) - ASU 2016-13 | Mar. 31, 2023 |
Change in accounting principle, accounting standards update, adoption date | Jan. 01, 2023 |
Change in accounting principle, accounting standards update, adopted | true |
Change in accounting principle, accounting standards update, immaterial effect | true |
F351 Asset Acquisition - Additi
F351 Asset Acquisition - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | Dec. 26, 2022 | May 08, 2023 |
Subsequent Event [Member] | ||
Asset Acquisition [Line Items] | ||
Common stock closing price | $ 0.21 | |
Conversion of outstanding preferred stock redeemed for cash | $ 25.9 | |
F351 Agreement | Convertible Preferred Stock | ||
Asset Acquisition [Line Items] | ||
Preferred stock shares issued | 12,340 | |
Preferred stock, shares issued upon conversion of common stock | 10,000 | |
Common Stock | F351 Agreement | ||
Asset Acquisition [Line Items] | ||
Assets acquisition, shares issued | 6,266,521 |
Fair Value Measurements - Asset
Fair Value Measurements - Assets and Liabilities Measured at Fair Value (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Assets, fair value | $ 12,649 | $ 21,666 | |
Liabilities, fair value | 9,550 | 5,000 | |
Long-term receivable | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Assets, fair value | 4,550 | ||
Money Market Funds | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Assets, fair value | [1] | 8,099 | 21,666 |
CVR Derivative Liability | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Liabilities, fair value | 5,000 | 5,000 | |
CVR Derivative Liability non current | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Liabilities, fair value | 4,550 | ||
Fair Value, Inputs, Level 1 | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Assets, fair value | 8,099 | 21,666 | |
Fair Value, Inputs, Level 1 | Money Market Funds | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Assets, fair value | [1] | 8,099 | 21,666 |
Fair Value, Inputs, Level 3 | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Assets, fair value | 4,550 | ||
Liabilities, fair value | 9,550 | 5,000 | |
Fair Value, Inputs, Level 3 | Long-term receivable | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Assets, fair value | 4,550 | ||
Fair Value, Inputs, Level 3 | CVR Derivative Liability | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Liabilities, fair value | 5,000 | $ 5,000 | |
Fair Value, Inputs, Level 3 | CVR Derivative Liability non current | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Liabilities, fair value | $ 4,550 | ||
[1]Included in cash and cash equivalents on the accompanying condensed consolidated balance sheets |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - Contingent Value Rights Agreement | 3 Months Ended | |||
Mar. 31, 2023 USD ($) | Mar. 31, 2025 USD ($) | Jun. 30, 2023 USD ($) | Dec. 26, 2022 USD ($) | |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||||
Initial derivative liability | $ 5,000,000 | |||
Change in the estimated fair value | $ 0 | |||
Vertex Asset Purchase Agreement | Forecast | ||||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||||
Amount to be received under agreement | $ 5,000,000 | |||
GCBP Asset Purchase Agreement | CVR Derivative Liability non current | Estimated Discount Rate | ||||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||||
Derivative liability measurement input | 0.0505 | |||
GCBP Asset Purchase Agreement | Long-term receivable | Estimated Discount Rate | ||||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||||
Derivative asset measurement input | 0.0505 | |||
GCBP Asset Purchase Agreement | Forecast | ||||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||||
Amount to be received under agreement | $ 5,000,000 |
Fair Value Measurements - Chang
Fair Value Measurements - Changes in Estimated Fair Value of Level 3 Financial Assets and Liabilities (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Long-term receivable | |
Fair Value Assets And Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |
Additions in the period | $ 4,530 |
Changes in fair value | 20 |
Balance at March 31, 2023 | 4,550 |
CVR Derivative Liability non current | |
Fair Value Assets And Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |
Additions in the period | 4,530 |
Changes in fair value | 20 |
Balance at March 31, 2023 | $ 4,550 |
Lease - Additional Information
Lease - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | |
Lessee Lease Description [Line Items] | |||
Lease expiration date | Apr. 30, 2023 | ||
Lessee operating lease renewal term description | no stated renewal options | ||
Operating lease expense | $ 100,000 | $ 500,000 | |
Sublease Arrangement | |||
Lessee Lease Description [Line Items] | |||
Lease commencement month and year | 2022-04 | ||
Lease expiration month and year | 2023-04 | ||
Lease payments receivable | $ 200,000 | 200,000 | |
Sublease Income | $ 38,000 | $ 0 |
Lease - Summary of Present Valu
Lease - Summary of Present Value Assumptions used in Calculating Present Value of Lease Payments (Detail) | Mar. 31, 2023 | Dec. 31, 2022 |
Lessee Disclosure [Abstract] | ||
Weighted-average remaining lease term | 0 years | 3 months 18 days |
Weighted-average discount rate | 0% | 4.30% |
Lease - Schedule of Supplementa
Lease - Schedule of Supplemental Cash Flow Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating Lease Liabilities Payments Due [Abstract] | ||
Cash paid for amounts included in the measurement of lease liabilities | $ 39 | $ 502 |
Stock Based Compensation - Addi
Stock Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | ||
Jan. 12, 2023 | Jun. 09, 2021 | Mar. 31, 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Number of common stock available for future grant | 25,521,867 | ||
Options vested | 0 | ||
Aggregate amount of special dividend payment | $ 7.6 | ||
Dividends paid | $ 0.24 | $ 0.24 | |
Dividends Payable, date declared | Jan. 12, 2023 | ||
Common stock, dividend payable, date of record | Jan. 05, 2023 | ||
Stock options granted during quarter | 0 | ||
2018 Omnibus Incentive Plan | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Increase in number of shares of common stock reserved for issuance | 2,500,000 | ||
Common stock, capital shares reserved for future issuance | 5,300,000 | 31,456,403 | |
2018 Omnibus Incentive Plan | Performance Based Stock Option Grants | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Issuance of option grants to purchase common stock shares | 400,000 | ||
2018 Omnibus Incentive Plan | Accounting Standards Update 2021-04 | Performance Based Stock Option Grants | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Issuance of option grants to purchase common stock shares | 2,457,917 |
Stock Based Compensation - Summ
Stock Based Compensation - Summary of Option Activity Under Company's Equity Incentive Plans (Detail) - $ / shares | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 | Dec. 31, 2022 | ||
Number of Shares Underlying Outstanding Options | |||
Number of Shares Underlying Outstanding Options, Beginning Balance | 8,678,767 | ||
Number of Shares Underlying Outstanding Options, Options granted | [1] | 14,008,093 | |
Number of Shares Underlying Outstanding Options, Options forfeited and cancelled | [1] | (14,210,119) | |
Number of Shares Underlying Outstanding Options, Options expired | (12,174) | ||
Number of Shares Underlying Outstanding Options, Ending Balance | 8,464,567 | 8,678,767 | |
Number of Shares Underlying Outstanding Options, Exercisable- March 31, 2023 | 7,306,692 | ||
Weighted- Average Exercise Price | |||
Weighted- Average Exercise Price, Beginning Balance | $ 1.42 | ||
Weighted- Average Exercise Price, Options granted | [1] | 0.86 | |
Weighted- Average Exercise Price, Options forfeited and cancelled | [1] | 0.91 | |
Weighted- Average Exercise Price, Options expired | 36.16 | ||
Weighted- Average Exercise Price, Ending Balance | 1.30 | $ 1.42 | |
Weighted- Average Exercise Price, Exercisable - March 31, 2022 | $ 1.40 | ||
Weighted-Average Remaining Contractual Term (Years) | |||
Weighted-Average Remaining Contractual Term (Years), Outstanding Balance | 6 years 3 days | 7 years 5 months 19 days | |
[1]Includes options that were cancelled and re-granted as part of the option modification from the special cash dividend, as further discussed above. |
Stock Based Compensation - Fair
Stock Based Compensation - Fair Values of Stock Options Estimated Using Black-Scholes Valuation Model (Detail) - Employee Stock Option - $ / shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Black Scholes Method Used [Line Items] | ||
Risk-free interest rate | 1.87% | |
Expected term (in years) | 6 years 1 month 6 days | |
Dividend yield | 0% | 0% |
Volatility | 91.54% | |
Weighted-average fair value of stock options granted | $ 0.39 |
Stock Based Compensation - Su_2
Stock Based Compensation - Summary of Stock-Based Compensation Expense Recognized (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | $ 210 | $ 515 | |
Research and development | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | 66 | 128 | |
General and Administrative | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | [1] | $ 144 | $ 387 |
[1]No shares of common stock were issued to board members for the three months ended March 31, 2023. |
Stock Based Compensation - Su_3
Stock Based Compensation - Summary of Stock-Based Compensation Expense Recognized (Parenthetical) (Detail) | 3 Months Ended |
Mar. 31, 2023 shares | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Number of shares of common stock issued to certain board members in lieu of cash compensation | 0 |
Collaborations - Additional Inf
Collaborations - Additional Information (Detail) - ISU Abxis - Amended and Restated License Agreement - USD ($) | 1 Months Ended | |
Feb. 28, 2023 | Dec. 31, 2018 | |
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||
Regulatory and development milestone payment | $ 2,500,000 | |
GCBP Asset Purchase Agreement | ||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||
Milestone payment | $ 0 | |
Regulatory and development milestone payment | 0 | |
Commercial milestone payments | $ 0 | |
Maximum | ||
Revenue Recognition Multiple Deliverable Arrangements [Line Items] | ||
Milestone payment | 19,500,000 | |
Commercial milestone payments | $ 17,000,000 |
Net Income (Loss) per Share A_3
Net Income (Loss) per Share Attributable to Common Stockholders - Anti-dilutive Security not Included In Diluted per Share Calculations (Detail) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti dilutive securities | 8,249,500 | 2,777,795 |
Options To Purchase Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti dilutive securities | 8,249,500 | 2,777,710 |
Common Stock Warrants | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti dilutive securities | 85 |
Net Income (Loss) per Share A_4
Net Income (Loss) per Share Attributable to Common Stockholders - Basic and Diluted Net Income (Loss) Per Share Attributable to Common Stockholders (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Earnings Per Share [Abstract] | ||
Net income (loss) | $ 260 | $ (14,536) |
Weighted-average number of shares used in computing net income (loss) per share available to common stockholders, basic | 37,758,416 | 31,456,090 |
Effect of dilutive stock options | 225,908 | |
Weighted-average number of shares used in computing net income (loss) per share available to common stockholders, diluted | 37,984,324 | 31,456,090 |
Net income (loss) per share available for common stockholders, basic | $ 0.01 | $ (0.46) |
Net income (loss) per share available for common stockholders, dilutive | $ 0.01 | $ (0.46) |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | ||
Mar. 08, 2023 | Mar. 31, 2023 | Mar. 31, 2023 | Feb. 28, 2023 | |
Commitments And Contingencies Disclosure [Line Items] | ||||
Long-term CVR derivative liability | $ 4,550,000 | $ 4,550,000 | ||
Contingent Value Rights Agreement | ||||
Commitments And Contingencies Disclosure [Line Items] | ||||
Long-term CVR derivative liability | $ 4,500,000 | |||
Distribution to CVR holders from asset sale proceeds | $ 200,000 | $ 200,000 | ||
Contingent Value Rights Agreement | ||||
Commitments And Contingencies Disclosure [Line Items] | ||||
Percentage of excess cash on dispositions net | 100% | |||
Percentage of excess cash on dispositions net | $ 1,000,000 | |||
Percentage of excess preapproved costs | 100% | |||
Vertex Asset Purchase Agreement | Contingent Value Rights Agreement | ||||
Commitments And Contingencies Disclosure [Line Items] | ||||
Percentage of amount received on agreement, net of expenses | 100% | |||
F351 | GNI | Business Combination Agreement | ||||
Commitments And Contingencies Disclosure [Line Items] | ||||
Termination fee required to pay upon termination of agreement | $ 2,000,000 | |||
F351 | GNI | Maximum | Business Combination Agreement | ||||
Commitments And Contingencies Disclosure [Line Items] | ||||
Common stock, shares issued | 1,110,776,224 | |||
Reimbursement for out-of-pocket fees and expenses | $ 2,000,000 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Income Tax [Line Items] | ||
Income tax expense (benefits) | $ 14,000 | $ 0 |
Research and Development Tax Credits | ||
Income Tax [Line Items] | ||
Income tax expense (benefits) | 0 | |
Federal Income Tax | ||
Income Tax [Line Items] | ||
Net operating loss carryforwards | 194,100,000 | |
State Income Tax | ||
Income Tax [Line Items] | ||
Net operating loss carryforwards | $ 3,600,000 | |
Net operating loss carryforwards expiration year | 2032 |
Restructuring - Additional Info
Restructuring - Additional Information (Detail) $ in Thousands | 1 Months Ended | 3 Months Ended | |||||||
Mar. 08, 2023 USD ($) | Mar. 31, 2023 USD ($) | Feb. 28, 2023 USD ($) | May 31, 2022 USD ($) | Mar. 31, 2022 Employee | Nov. 30, 2021 | Mar. 31, 2023 USD ($) | Jun. 30, 2022 USD ($) | Mar. 31, 2022 USD ($) | |
Restructuring Cost And Reserve [Line Items] | |||||||||
Percent of employees terminated | 35% | ||||||||
Number of Employees terminated | Employee | 22 | ||||||||
Remaining number of full time employees | Employee | 5 | ||||||||
Proceeds from Sale of Intangible Assets | $ 1,000 | ||||||||
Gain (loss) on disposal | 4,736 | ||||||||
Contingent Value Rights Agreement | |||||||||
Restructuring Cost And Reserve [Line Items] | |||||||||
Distribution to CVR holders from asset sale proceeds | $ 200 | $ 200 | |||||||
Vertex Pharmaceuticals Incorporated | |||||||||
Restructuring Cost And Reserve [Line Items] | |||||||||
Proceeds from Sale of Intangible Assets | $ 60,000 | ||||||||
Upfront payment received | 55,000 | ||||||||
Post closing indemnification obligation | 5,000 | ||||||||
Gain (loss) on disposal | $ 57,400 | ||||||||
Transaction costs | $ 2,600 | ||||||||
GCBP Asset Purchase Agreement | |||||||||
Restructuring Cost And Reserve [Line Items] | |||||||||
Proceeds from Sale of Intangible Assets | $ 6,000 | ||||||||
Upfront payment received | 1,000 | ||||||||
Post closing indemnification obligation | 5,000 | ||||||||
Gain (loss) on disposal | $ 4,700 | ||||||||
Transaction costs | $ 800 | ||||||||
Operating Expense | |||||||||
Restructuring Cost And Reserve [Line Items] | |||||||||
Restructuring costs | $ 1,000 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) | 3 Months Ended | |
Apr. 18, 2023 USD ($) Agreement | Mar. 31, 2023 USD ($) | |
Subsequent Event [Line Items] | ||
Expenses incurred under cost sharing agreement | $ 0 | |
Subsequent Event [Member] | ||
Subsequent Event [Line Items] | ||
Number of separate agreements | Agreement | 2 | |
Non GMP Manufacturing Services [Member] | Subsequent Event [Member] | ||
Subsequent Event [Line Items] | ||
Cost of services as per agreement | $ 300,000 | |
Clinical Supply Batch GMP Manufacturing [Member] | Subsequent Event [Member] | ||
Subsequent Event [Line Items] | ||
Cost of services as per agreement | $ 200,000 |