Taysha Gene Therapies, Inc. 10-Q

Item 1. Financial Statements. Taysha Gene Therapies, Inc. Condensed Consolidated Balance Sheets (in thousands, except share and per share data) (Unaudited) June 30, 2022 December 31, 2021 ASSETS Current assets: Cash and cash equivalents $ 66,239 $ 149,103 Prepaid expenses and other current assets 10,596 10,499 Total current assets 76,835 159,602 Restricted cash 2,637 2,637 Deferred lease asset 643 667 Property, plant and equipment, net 61,011 50,610 Other non-current assets 1,206 440 Total assets $ 142,332 $ 213,956 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable $ 23,967 $ 21,763 Accrued expenses and other current liabilities 18,986 29,983 Total current liabilities 42,953 51,746 Build-to-suit lease liability 25,609 25,900 Term loan, net 37,580 37,192 Other non-current liabilities 3,480 3,735 Total liabilities 109,622 118,573 Commitments and contingencies - Note 9 Stockholders' equity Preferred stock, $ 0.00001 par value per share; 10,000,000 shares authorized and no shares issued and outstanding as of June 30, 2022 and December 31, 2021 — — Common stock, $ 0.00001 par value per share; 200,000,000 shares authorized and 41,020,086 and 38,473,945 issued and outstanding as of June 30, 2022 and December 31, 2021, respectively 1 — Additional paid-in capital 352,342 331,032 Accumulated deficit ( 319,633 ) ( 235,649 ) Total stockholders’ equity 32,710 95,383 Total liabilities and stockholders' equity $ 142,332 $ 213,956 The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 1 Taysha Gene Therapies, Inc. Condensed Consolidated Statements of Operations (in thousands, except share and per share data) (Unaudited) For the Three Months Ended June 30, For the Six Months Ended June 30, 2022 2021 2022 2021 Operating expenses: Research and development $ 23,118 $ 30,643 $ 60,917 $ 54,497 General and administrative 9,867 10,129 21,336 18,365 Total operating expenses 32,985 40,772 82,253 72,862 Loss from operations ( 32,985 ) ( 40,772 ) ( 82,253 ) ( 72,862 ) Other income (expense): Interest income 27 40 41 106 Interest expense ( 912 ) ( 194 ) ( 1,761 ) ( 194 ) Other expense ( 3 ) — ( 11 ) — Total other expense, net ( 888 ) ( 154 ) ( 1,731 ) ( 88 ) Net loss $ ( 33,873 ) $ ( 40,926 ) $ ( 83,984 ) $ ( 72,950 ) Net loss per common share, basic and diluted $ ( 0.84 ) $ ( 1.09 ) $ ( 2.14 ) $ ( 1.96 ) Weighted average common shares outstanding, basic and diluted 40,142,403 37,479,164 39,163,996 37,237,115 The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 2 Taysha Gene Therapies, Inc. Condensed Consolidated Statements of Stockholders’ Equity (in thousands, except share data) (Unaudited) For the Three Months Ended June 30, 2022 Additional Total Common Stock Paid-in Accumulated Stockholders' Shares Amount Capital Deficit Equity Balance as of March 31, 2022 38,473,945 $ — $ 336,485 $ ( 285,760 ) $ 50,725 Stock-based compensation — — 4,249 — 4,249 Issuance of common stock, net of sales commissions and other offering costs of $ 392 2,000,000 1 11,608 — 11,609 Issuance of common stock upon vesting and settlement of restricted stock units 546,141 — — — — Net loss — — — ( 33,873 ) ( 33,873 ) Balance as of June 30, 2022 41,020,086 $ 1 $ 352,342 $ ( 319,633 ) $ 32,710 For the Three Months Ended June 30, 2021 Additional Total Common Stock Paid-in Accumulated Stockholders' Shares Amount Capital Deficit Equity Balance as of March 31, 2021 37,761,435 $ — $ 316,022 $ ( 93,150 ) $ 222,872 Stock-based compensation — — 4,549 — 4,549 Issuance of common stock upon vesting and settlement of restricted stock units 629,730 — — — — Net loss — — — ( 40,926 ) ( 40,926 ) Balance as of June 30, 2021 38,391,165 $ — $ 320,571 $ ( 134,076 ) $ 186,495 The accompanying notes are an integral part of these unaudited condensed consolidated financial statements 3 Taysha Gene Therapies, Inc. Condensed Consolidated Statements of Stockholders’ Equity (in thousands, except share data) (Unaudited) For the Six Months Ended June 30, 2022 Additional Total Common Stock Paid-in Accumulated Stockholders' Shares Amount Capital Deficit Equity Balance as of December 31, 2021 38,473,945 $ — $ 331,032 $ ( 235,649 ) $ 95,383 Stock-based compensation — — 9,702 — 9,702 Issuance of common stock, net of sales commissions and other offering costs of $ 392 2,000,000 1 11,608 — 11,609 Issuance of common stock upon vesting and settlement of restricted stock units 546,141 — — — — Net loss — — — ( 83,984 ) ( 83,984 ) Balance as of June 30, 2022 $ 41,020,086 $ 1 $ 352,342 $ ( 319,633 ) $ 32,710 For the Six Months Ended June 30, 2021 Additional Total Common Stock Paid-in Accumulated Stockholders' Shares Amount Capital Deficit Equity Balance as of December 31, 2020 37,761,435 $ — $ 312,428 $ ( 61,126 ) $ 251,302 Stock-based compensation — — 8,143 — 8,143 Issuance of common stock upon vesting and settlement of restricted stock units 629,730 — — — — Net loss — — — ( 72,950 ) ( 72,950 ) Balance as of June 30, 2021 38,391,165 $ — $ 320,571 $ ( 134,076 ) $ 186,495 The accompanying notes are an integral part of these unaudited condensed consolidated financial statements 4 Taysha Gene Therapies, Inc. Condensed Consolidated Statements of Cash Flows (in thousands) (Unaudited) For the Six Months Ended June 30, 2022 2021 Cash flows from operating activities Net loss $ ( 83,984 ) $ ( 72,950 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation expense 531 117 Research and development license expense 1,250 5,500 Stock-based compensation 9,470 8,143 Other 387 194 Changes in operating assets and liabilities: Prepaid expenses and other assets 80 ( 3,282 ) Accounts payable 6,212 2,382 Accrued expenses and other liabilities ( 7,958 ) 15,053 Due to related party — ( 8 ) Net cash used in operating activities ( 74,012 ) ( 44,851 ) Cash flows from investing activities Purchase of research and development license ( 3,250 ) ( 5,500 ) Purchase of property, plant and equipment ( 16,290 ) ( 3,532 ) Net cash used in investing activities ( 19,540 ) ( 9,032 ) Cash flows from financing activities Payment of shelf registration costs ( 227 ) — ESPP contributions 321 — Proceeds from issuance of common stock, net of sales commissions 11,640 — Other ( 1,046 ) — Net cash provided by financing activities 10,688 — Net decrease in cash, cash equivalents and restricted cash ( 82,864 ) ( 53,883 ) Cash, cash equivalents and restricted cash at the beginning of the period 151,740 251,253 Cash, cash equivalents and restricted cash at the end of the period $ 68,876 $ 197,370 Cash and cash equivalents 66,239 197,370 Restricted cash 2,637 — Cash, cash equivalents and restricted cash at the end of the period $ 68,876 $ 197,370 Supplemental disclosure of cash flow information: Cash paid for interest $ 935 $ — Supplemental disclosure of noncash investing and financing activities: Property, plant and equipment in accounts payable and accrued expenses 2,722 3,308 Acquisition of property, plant and equipment funded by landlord — 606 Deferred offering costs not yet paid 109 — Purchase of research and development license not yet paid 1,000 — Build-to-suit lease liability — 26,250 The accompanying notes are an integral part of these unaudited condensed consolidated financial statements 5 Note 1—Organization and Description of Business Operations Taysha Gene Therapies, Inc. (the “Company” or “Taysha”) was originally formed under the laws of the State of Texas on September 20, 2019 (“Inception”). Taysha converted to a Delaware corporation on February 13, 2020 , which had no impact to the Company’s par value or issued and authorized capital structure. Taysha is a patient-centric gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system in both rare and large patient populations. Sales Agreement On October 5, 2021, the Company entered into a Sales Agreement (the “Sales Agreement”) with SVB Securities LLC (f/k/a SVB Leerink LLC) and Wells Fargo Securities, LLC (collectively, the “Sales Agents”), pursuant to which the Company may issue and sell, from time to time in its sole discretion, shares of its common stock having an aggregate offering price of up to $ 150.0 million through the Sales Agents. In March 2022, the Company amended the Sales Agreement to, among other things, include Goldman Sachs & Co. LLC as an additional Sales Agent. The Sales Agents may sell common stock by any method permitted by law deemed to be an “at-the-market offering” as defined in Rule 415(a)(4) of the Securities Act, including sales made directly on or through the Nasdaq Global Select Market or any other existing trade market for the common stock, in negotiated transactions at market prices prevailing at the time of sale or at prices related to prevailing market prices, or any other method permitted by law. The Sales Agents are entitled to receive 3.0 % of the gross sales price per share of common stock sold under the Sales Agreement. In April 2022, the Company sold 2,000,000 shares of common stock under the Sales Agreement and received $ 11.6 million in net proceeds. No other shares of common stock have been issued and sold pursuant to the Sales Agreement as of June 30, 2022. Going Concern The accompanying condensed consolidated financial statements are prepared in accordance with generally accepted accounting principles applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred operating losses since inception and expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. As of June 30, 2022, the Company had an accumulated deficit of $ 319.6 million and cash and cash equivalents of $ 66.2 million . Losses are expected to continue as the Company continues to invest in its research and development activities. Management believes that there is presently insufficient funding available to allow the Company to fund its currently planned research and discovery programs and the build-out of its GMP manufacturing facility for a period exceeding one year from the date of this filing with the Securities and Exchange Commission. These conditions and events raise substantial doubt about the Company’s ability to continue as a going concern. In response to these conditions and to meet the Company’s capital requirements, management plans to use its current cash on hand, along with access to the term loan facility (see Note 4), and some combination of the following: (i) dilutive and/or non-dilutive financings, (ii) out-licensing or strategic alliances/collaborations, and (iii) out-licensing or sale of its non-core assets. If the Company raises additional funds through collaborations, strategic alliances, business development or licensing arrangements with third parties, the Company might have to relinquish valuable rights to its technologies, future revenue streams, research programs or product candidates. However, these plans have not yet been finalized and are not within the Company’s control, and therefore cannot be deemed probable. As a result, the Company has concluded that management’s plans do not alleviate substantial doubt about the Company’s ability to continue as a going concern. 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. 6 Note 2—Summary of Significant Accounting Policies Basis of Presentation The unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States ("GAAP") as determined by the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X and are consistent in all material respects with those included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, filed with the Securities and Exchange Commission ("SEC") on March 31, 2022 (the “2021 Annual Report”). In the opinion of management, the unaudited condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results for the periods presented. The consolidated balance sheet as of December 31, 2021 is derived from audited financial statements, however, it does not include all of the information and footnotes required by GAAP for complete financial statements. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and related notes in the Company’s 2021 Annual Report. Principles of Consolidation The accompanying interim condensed consolidated financial statements include the accounts of Taysha and its inactive wholly owned U.S. subsidiaries as well as t wo foreign subsidiaries incorporated during 2021 . All intercompany transactions and balances have been eliminated in consolidation. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. The most significant estimates and assumptions in the Company’s financial statements relate to the determination of the fair value of the common stock prior to the Company’s initial public offering (“IPO”) in September 2020 (as an input into stock-based compensation), and estimating preclinical manufacturing accruals and accrued or prepaid research and development expenses. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected. In response to the ongoing and rapidly evolving COVID-19 pandemic, management considered the impact of the estimated economic implications on the Company’s critical and significant accounting estimates, including assessment of impairment of long-lived assets. Significant Accounting Policies There have been no changes in the Company’s significant accounting policies as disclosed in Note 2 to the audited consolidated financial statements included in the 2021 Annual Report. Comprehensive Loss Comprehensive loss is equal to net loss as presented in the accompanying condensed consolidated statements of operations. Recently Issued Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), as amended, with guidance regarding the accounting for and disclosure of leases. This update requires lessees to recognize the liabilities related to all leases, including operating leases, with a term greater than 12 months on the balance sheets. This update also requires lessees and lessors to disclose key information about their leasing transactions. This guidance will become effective for the Company for annual reporting periods beginning after December 15, 2021 and interim periods within fiscal years beginning after December 15, 2022. The new standard requires the use of one of the following two approaches, either (1) retrospectively to each prior reporting period presented in the financial statements with the cumulative effect recognized at the beginning of the earliest comparative period presented, or (2) retrospectively at the beginning of the period of adoption through a cumulative-effect adjustment. The Company has not yet concluded which approach will be utilized to adopt the new standard and is currently evaluating the impact of this standard on its condensed consolidated financial statements. 7 Note 3—Balance Sheet Components Prepaid expenses and other current assets consisted of the following (in thousands): June 30, 2022 December 31, 2021 Prepaid research and development $ 6,128 $ 5,218 Prepaid clinical trial 2,934 3,298 Deferred offering costs 698 545 Prepaid insurance 108 148 Prepaid bonus 51 427 Other 677 863 Total prepaid expenses and other current assets $ 10,596 $ 10,499 Property, plant and equipment consisted of the following (in thousands): June 30, 2022 December 31, 2021 Leasehold improvements $ 2,090 $ 2,067 Laboratory equipment 1,438 1,095 Computer equipment 1,129 1,098 Furniture and fixtures 896 845 Construction in progress 56,474 46,004 62,027 51,109 Accumulated depreciation ( 1,016 ) ( 499 ) Property, plant and equipment, net $ 61,011 $ 50,610 Included in construction in progress at June 30, 2022 was $ 56.3 million of costs associated with the Build-to-Suit lease (see Note 9), which includes $ 3.1 million of capitalized payroll and payroll-related costs. Depreciation expense was $ 0.3 million and $ 0.5 million for the three and six months ended June 30, 2022, respectively. Depreciation expense was less than $ 0.1 million and $ 0.1 million for the three and six months ended June 30, 2021, respectively. Accrued expenses and other current liabilities consisted of the following (in thousands): June 30, 2022 December 31, 2021 Accrued research and development $ 8,918 $ 11,895 Accrued compensation 4,620 7,703 Accrued license fees 1,500 3,500 Accrued property, plant and equipment 1,224 2,644 Accrued clinical trial 807 1,659 Accrued professional and consulting fees 439 1,091 Other 1,478 1,491 Total accrued expenses and other current liabilities $ 18,986 $ 29,983 Note 4—Loan with Silicon Valley Bank On August 12, 2021 (the “Closing Date”), the Company entered into a Loan and Security Agreement (the “Term Loan Agreement”), by and among the Company, the lenders party thereto from time to time (the “Lenders”) and Silicon Valley Bank, as administrative agent and collateral agent for the Lenders (“Agent”). The Term Loan Agreement provides for (i) on the Closing Date, $ 40.0 million aggregate principal amount of term loans available through December 31, 2021 , (ii) from January 1, 2022 until September 30, 2022 , an additional $ 20.0 million term loan facility available at the Company’s option upon having three distinct and active clinical stage programs, determined at the discretion of the Agent, at the time of draw, (iii) from October 1, 2022 until March 31, 2023 , an additional $ 20.0 million term loan facility available at the Company’s option upon having three distinct and active clinical stage programs, determined at the discretion of the Agent, at the time of draw and (iv) from April 1, 2023 until December 31, 2023 , an additional $ 20.0 million term loan facility available upon approval by the Agent and the Lenders (collectively, the “Term Loans”). The Company drew $ 30.0 million in term loans on the Closing Date and $ 10.0 million in term loans in December 2021. 8 The interest rate applicable to the Term Loans is the greater of (a) the WSJ Prime Rate plus 3.75 % or (b) 7.00 % per annum. The Term Loans are interest only from the Closing Date through August 31, 2024, after which the Company is required to pay equal monthly installments of principal through August 1, 2026 , the maturity date. The Term Loans may be prepaid in full through August 12, 2022 with payment of a 2.00 % prepayment premium, after which they may be prepaid in full through August 12, 2023 with payment of a 1.00 % prepayment premium, after which they may be prepaid in full with no prepayment premium. An additional final payment of 7.5 % of the amount of Terms Loans advanced by the Lenders (“Exit Fee”) will be due upon prepayment or repayment of the Term Loans in full. The Exit Fee of $ 3.0 million was recorded as debt discount and has also been fully accrued within non-current liabilities as of June 30, 2022. The debt discount is being accreted using the effective interest method over the term of the Term Loans within interest expense in the condensed consolidated statements of operations. The obligations under the Term Loan Agreement are secured by a perfected security interest in all of the Company’s assets except for intellectual property and certain other customarily excluded property pursuant to the terms of the Term Loan Agreement. There are no financial covenants and no warrants associated with the Term Loan Agreement. The Term Loan Agreement contains various covenants that limit the Company’s ability to engage in specified types of transactions without the consent of the Lenders which include, among others, incurring or assuming certain debt; merging, consolidating or acquiring all or substantially all of the capital stock or property of another entity; changing the nature of the Company’s business; changing the Company’s organizational structure or type; licensing, transferring or disposing of certain assets; granting certain types of liens on the Company’s assets; making certain investments; and paying cash dividends. The Term Loan Agreement also contains customary representations and warranties, and also includes customary events of default, including payment default, breach of covenants, change of control, and material adverse effects. The Company was in compliance with all covenants under the Term Loan Agreement as of June 30, 2022. Upon the occurrence of an event of default, a default interest rate of an additional 5 % per annum may be applied to the outstanding loan balances, and the Lenders may declare all outstanding obligations immediately due and payable and exercise all of its rights and remedies as set forth in the Term Loan Agreement and under applicable law. During the six months ended June 30, 2022, the Company recognized interest expense related to the Term Loan of $ 1.4 million. Future principal debt payments on the loan payable as of June 30, 2022 are as follows (in thousands): Year Ending December 31, 2022 — 2023 — 2024 6,667 2025 20,000 2026 13,333 Total principal payments 40,000 Unamortized debt discount ( 2,420 ) Term Loan, net $ 37,580 Note 5—Research, Collaboration and License Agreements UT Southwestern Agreement On November 19, 2019, the Company entered into a research, collaboration and license agreement (“UT Southwestern Agreement”) with the Board of Regents of the University of Texas System on behalf of The University of Texas Southwestern Medical Center (“UT Southwestern”). Under the UT Southwestern Agreement, UT Southwestern is primarily responsible for preclinical development activities with respect to licensed products for use in certain specified indications (up to investigational new 9 drug application -enabling studies), and the Company is responsible for all subsequent clinical development and commercialization activities with respect to the licensed products. UT Southwestern will conduct such preclinical activities for a two-year period under mutually agreed upon sponsored research agreements that were entered into beginning in April 2020. During the initial research phase, the Company has the right to expand the scope of specified indications under the UT Southwestern Agreement. In connection with the UT Southwestern Agreement, the Company obtained an exclusive, worldwide, royalty-free license under certain patent rights of UT Southwestern and a non-exclusive, worldwide, royalty-free license under certain know-how of UT Southwestern, in each case to make, have made, use, sell, offer for sale and import licensed products for use in certain specified indications. Additionally, the Company obtained a non-exclusive, worldwide, royalty-free license under certain patents and know-how of UT Southwestern for use in all human uses, with a right of first refusal to obtain an exclusive license under certain of such patent rights and an option to negotiate an exclusive license under other of such patent rights. The Company is required to use commercially reasonable efforts to develop, obtain regulatory approval for, and commercialize at least one licensed product. On April 2, 2020, the Company amended the UT Southwestern Agreement to include the addition of another licensed product and certain indications, and a right of first refusal to the Company over certain patient dosing patents. No additional consideration was transferred in connection with this amendment. In March 2022, the Company and UT Southwestern mutually agreed to revise the payment schedules and current performance expectations of the current sponsored research agreements under the UT Southwestern Agreement and defer payments by fifteen months. The UT Southwestern Agreement expires on a country-by-country and licensed product-by-licensed product basis upon the expiration of the last valid claim of a licensed patent in such country for such licensed product. After the initial research term, the Company may terminate the agreement, on an indication-by-indication and licensed product-by-licensed product basis, at any time upon specified written notice to UT Southwestern. Either party may terminate the agreement upon an uncured material breach of the agreement or insolvency of the other party. In November 2019, as partial consideration for the license rights granted under the UT Southwestern Agreement, the Company issued 2,179,000 shares of its common stock, or 20 % of its then outstanding fully-diluted common stock, to UT Southwestern. As additional consideration, UT Southwestern was entitled to receive additional shares if their holdings fell below 10 % on a fully-diluted basis before or as a result of the completion of a qualified financing. In March 2020, following the initial closing of the Series A convertible preferred stock agreement, which met the definition of such qualified financing, the anti-dilution feature expired and no additional shares were issued. UT Southwestern no longer owns such shares of common stock as of January 2022. The Company does not have any future milestone or royalty obligations to UT Southwestern under the UT Southwestern Agreement other than costs related to maintenance of patents. Queen’s Agreement On February 21, 2020, the Company entered into a license agreement with Queen’s (the “Queen’s Agreement”) to obtain the exclusive perpetual, royalty-bearing license, with the right to sublicense through multiple tiers, under certain patent rights and know-how of Queen’s, including certain improvements to such patent rights and know-how, to develop products in any field which use one or more valid claims of the patents licensed under the Queen’s Agreement (the “Licensed Patents”), or the technology, information and intellectual property related to the patents licensed under the Queen’s Agreement (together with the Licensed Patents, the “Licensed Products”), and to make, have made, use, sell, offer for sale, import and export Licensed Products and otherwise exploit such patents and know-how for use in certain specified indications. In exchange for the rights granted to the Company, the Company made a cash payment of $ 3.0 million in April 2020 which was recorded within research and development expenses in the consolidated statements of operations for the year ended December 31, 2020 since the acquired license does not have an alternative future use. The Company is obligated to make aggregate cash payments of up to $ 10.0 million upon the completion of a combination of regulatory milestones and up to $ 10.0 million upon the completion of a combination of commercial milestones. In further consideration of the rights granted, beginning with the Company’s first commercial sale of the Licensed Products, the Company will also pay an annual earned royalty in the low single digits on net sales of Licensed Products, subject to certain customary reductions, and a percentage of non-royalty sublicensing revenue ranging in the low double digits. Royalties are payable, on a Licensed Products-by-Licensed Products and a country-by-country basis, until expiration of the last valid claim of a Licensed Patent covering such Licensed Products in such country and the expiration of any regulatory exclusivity for such Licensed Products in such country. No additional milestone payments were made in connection with the Queen’s Agreement during the six months ended June 30, 2022. 10 Abeona CLN1 Agreements In August 2020, the Company entered into license and inventory purchase agreements (collectively, the “Abeona Agreements”) with Abeona Therapeutics Inc. (“Abeona”) for worldwide exclusive rights to certain intellectual property rights and know-how relating to the research, development and manufacture of ABO-202, an AAV-based gene therapy for CLN1 disease (also known as infantile Batten disease). Under the terms of the Abeona Agreements, the Company made initial cash payments to Abeona of $ 3.0 million for the license fee and $ 4.0 million for purchase of clinical materials and reimbursement for previously incurred development costs in October 2020. In exchange for the license rights, the Company recorded an aggregate of $ 7.0 million within research and development expenses in the consolidated statements of operations for the year ended December 31, 2020 since the acquired license or acquired inventory do not have an alternative future use. The Company is obligated to make up to $ 26.0 million in regulatory-related milestones and up to $ 30.0 million in sales-related milestones per licensed CLN1 product. The Company will also pay an annual earned royalty in the high single digits on net sales of any licensed CLN1 products. The license agreement with Abeona (the “Abeona License Agreement”) expires on a country-by-country and licensed product-by-licensed product basis upon the expiration of the last royalty term of a licensed product. Either party may terminate the Abeona License Agreement upon an uncured material breach of the agreement or insolvency of the other party. The Company may terminate the Abeona License Agreement for convenience upon specified prior written notice to Abeona. In December 2021, the Company’s Clinical Trial Application (“CTA”) filing for TSHA-118 for the treatment of CLN1 disease was approved by Health Canada and therefore triggered a regulatory milestone payment in connection with this agreement. The Company recorded $ 3.0 million within research and development expenses in the consolidated statements of operations for the year ended December 31, 2021. The milestone fee was paid in January 2022 and classified as an investing cash outflow in the condensed consolidated statements of cash flows for the six months ended June 30, 2022. Abeona Rett Agreement On October 29, 2020, the Company entered into a license agreement (the “Abeona Rett Agreement”) with Abeona pursuant to which the Company obtained an exclusive, worldwide, royalty-bearing license, with the right to grant sublicenses under certain patents, know-how and materials originally developed by the University of North Carolina at Chapel Hill, the University of Edinburgh and Abeona to research, develop, manufacture, have manufactured, use, and commercialize licensed products for gene therapy and the use of related transgenes for Rett syndrome. Subject to certain obligations of Abeona, the Company is required to use commercially reasonable efforts to develop at least one licensed product and commercialize at least one licensed product in the United States. In connection with the Abeona Rett Agreement, the Company paid Abeona a one-time upfront license fee of $ 3.0 million which was recorded in research and development expenses in the consolidated statements of operations for the year ended December 31, 2020 since the acquired license does not have an alternative future use. The Company is obligated to pay Abeona up to $ 26.5 million in regulatory-related milestones and up to $ 30.0 million in sales-related milestones per licensed Rett product and high single-digit royalties on net sales of licensed Rett products. Royalties are payable on a licensed product-by-licensed product and country-by-country basis until the latest of the expiration or revocation or complete rejection of the last licensed patent covering such licensed product in the country where the licensed product is sold, the loss of market exclusivity in such country where the product is sold, or, if no licensed product exists in such country and no market exclusivity exists in such country, ten years from first commercial sale of such licensed product in such country. The Abeona Rett Agreement expires on a country-by-country and licensed product-by-licensed product basis upon the expiration of the last royalty term of a licensed product. Either party may terminate the agreement upon an uncured material breach of the agreement or insolvency of the other party. The Company may terminate the agreement for convenience upon specified prior written notice to Abeona. In March 2022, the Company’s CTA filing for TSHA-102 for the treatment of Rett Syndrome was approved by Health Canada and therefore triggered a regulatory milestone payment in connection with this agreement. The Company recorded $ 1.0 million within research and development expenses in the condensed consolidated statements of operations for the six months ended June 30, 2022. The $ 1.0 million regulatory milestone fee was paid in July 2022. 11 Acquisition of Worldwide Rights for TSHA-120 for the treatment of GAN In March 2021, the Company acquired the exclusive worldwide rights to a clinical-stage AAV9 gene therapy program, now known as TSHA-120, for the treatment of Giant Axonal Neuropathy (“GAN”). TSHA-120 is an intrathecally dosed AAV9 gene therapy currently being evaluated in a clinical trial for the treatment of GAN. The trial is being conducted by the National Institutes of Health (“NIH”) in close collaboration with a leading patient advocacy group focused on finding treatments and cures for GAN. TSHA-120 has received rare pediatric disease and orphan drug designations from the U.S. Food and Drug Administration for the treatment of GAN. The worldwide rights were acquired through a license agreement, effective March 29, 2021, between Hannah’s Hope Fund for Giant Axonal Neuropathy, Inc. (“HHF”) and the Company (the “GAN Agreement”). Under the terms of the GAN Agreement, in exchange for granting the Company the exclusive worldwide rights to TSHA-120, HHF received an upfront payment of $ 5.5 million and will be eligible to receive clinical, regulatory and commercial milestones totaling up to $ 19.3 million, as well as a low, single-digit royalty on net sales upon commercialization of the product. In exchange for the license rights, the Company recorded an aggregate of $ 5.5 million within research and development expenses in the condensed consolidated statements of operations for the six months ended June 30, 2021, since the acquired license does not have an alternative future use. This license fee was paid in April 2021 and has been classified as an investing outflow in the condensed consolidated statements of cash flows for the six months ended June 30, 2021. No additional milestone payments were made in connection with the GAN Agreement during the six months ended June 30, 2022. License Agreement for CLN7 In March 2022, the Company entered into a license agreement with UT Southwestern (the “CLN7 Agreement”) pursuant to which the Company obtained an exclusive worldwide, royalty-bearing license with right to grant sublicenses to develop, manufacture, use, and commercialize licensed products for gene therapy for CLN7, a form of Batten Disease In connection with the CLN7 Agreement, the Company paid one-time up-front license fee of $ 0.3 million. The Company recorded the up-front license fee in research and development expense in the condensed consolidated statements of operations since the acquired license does not have an alternative future use. The up-front license fee was classified as an investing cash outflow in the condensed consolidated statements of cash flows for the six months ended June 30, 2022. The Company is obligated to pay UT Southwestern up to $ 7.7 million in regulatory-related milestones and up to $ 7.5 million in sales-related milestones, as well as a low, single-digit royalty on net sales upon commercialization of the product. Note 6—Stock-Based Compensation On July 1, 2020, the Company’s board of directors approved the 2020 Equity Incentive Plan (“Existing Plan”) which permits the granting of incentive stock options, non-statutory stock options, stock appreciation rights, RSAs, RSUs and other stock-based awards to employees, directors, officers and consultants. On July 1, 2020, 3,529,412 shares of common stock were authorized for issuance under the Existing Plan. On September 16, 2020, the Company increased the number of shares of common stock authorized for issuance under the Existing Plan to 3,845,294 . As of September 16, 2020, the approval date of the New Plan (as defined below), no additional awards will be granted under the Existing Plan. The terms of the Existing Plan will continue to govern the terms of outstanding equity awards that were granted prior to approval of the New Plan. On September 16, 2020, the Company’s stockholders approved the 2020 Stock Incentive Plan (“New Plan”), which became effective upon the execution of the underwriting agreement in connection with the IPO. Initially, the number of shares available for future issuance under the New Plan was the sum of (1) 3,390,168 new shares of common stock, (2) 209,841 remaining shares of common stock reserved under the Existing Plan that became available for issuance upon the effectiveness of the New Plan and (3) the number of shares of common stock subject to outstanding awards under the Existing Plan when the New Plan became effective that thereafter expire or are forfeited, canceled, withheld to satisfy tax withholding or to purchase or exercise an award, repurchased by the Company or are otherwise terminated. The number of shares of common stock reserved for issuance under the New Plan automatically increases on January 1 of each year, for a period of ten years , from January 1, 2021 continuing through January 1, 2030 , by 5 % of the total number of shares of common stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares as may be determined by the Company’s board of directors. On January 1, 2021 the Company’s board of directors increased the number of shares of common stock reserved for issuance under the New Plan by 1,434,934 shares. On January 1, 2022 the Company’s board of directors increased the number of shares of common stock reserved for issuance under the New Plan by 1,923,697 shares. 12 Furthermore, on September 16, 2020, the Company’s stockholders approved the Employee Stock Purchase Plan (“ESPP”), which became effective upon the execution of the underwriting agreement in connection with the IPO. The maximum number of shares of common stock that may be issued under the ESPP will not exceed 362,000 shares of common stock, plus the number of shares of common stock that are automatically added on January 1st of each year for a period of up to ten years , commencing on the first January 1 following the IPO and ending on (and including) January 1, 2030 , in an amount equal to the lesser of ( i ) one percent ( 1.0 %) of the total number of shares of capital stock outstanding on December 31st of the preceding calendar year, and (ii) 724,000 shares of common stock. No shares were added to the ESPP in 2021 . On January 1, 2022, the Company’s board of directors increased the number of shares of common stock reserved for issuance under the ESPP by 384,739 . No issuance s have been made under the ESPP as of June 3 0 , 2022 . Stock Options On July 1, 2020, options to purchase 2,896,782 shares of common stock under the Existing Plan were awarded to certain employees and consultants of the Company with an exercise price per share of $ 0.80 , which were expected to vest over a four-year period, all of which were subsequently cancelled (the “Cancelled Options”). The grant date fair value of the Cancelled Options was $ 13.8 million at the original grant date. In exchange, the Company awarded 2,518,932 RSUs on September 2, 2020, which are expected to vest over a four-year term. The Company accounted for the changes in award terms as a modification in accordance with ASC 718 Compensation – Stock Compensation. The modification was accounted for as an exchange of the original award for a new award with total compensation cost equal to the grant-date fair value of the original award plus any incremental value measured on the modification date. The Company determined that there was no incremental value as the fair value of the original award immediately before the modification was greater than the fair value of the new award immediately after the modification. Accordingly, the Company continues to recognize the remaining compensation cost of the Cancelled Options over the vesting period of the RSUs. For the three months ended June 30, 2022, 777,852 shares of common stock under the New Plan were awarded with a weighted-average grant date fair value per share of $ 4.13 . For the six months ended June 30, 2022 2,679,952 shares of common stock under the New Plan were awarded with a weighted-average grant date fair value per share of $ 4.21 . The stock options vest over one to four years and have a ten-year contractual term. The following weighted-average assumptions were used to estimate the fair value of stock options that were granted during the three and six months ended June 30, 2022 and 2021: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Risk-free interest rate 2.77 % 1.07 % 2.16 % 0.80 % Expected dividend yield — — — — Expected term in years 6.0 6.0 6.1 6.0 Expected volatility 76 % 76 % 76 % 75 % The following table summarizes stock option activity, during the six months ended June 30, 2022: Weighted Weighted Average Aggregate Average Remaining Intrinsic Stock Exercise Contractual Value Options Price Life (in years) (in thousands) Outstanding at December 31, 2021 3,649,962 $ 24.13 9.2 $ — Options granted 2,679,952 6.24 Options cancelled or forfeited ( 1,170,879 ) 15.53 Options expired ( 10,340 ) 21.71 Outstanding at June 30, 2022 5,148,695 $ 16.78 8.9 $ 85 Vested and expected to vest at June 30, 2022 5,148,695 $ 16.78 8.9 $ 85 Options exercisable at June 30, 2022 1,094,502 $ 25.03 7.9 $ — The aggregate intrinsic value in the above table is calculated as the difference between the fair value of the Company’s common stock as of June 30, 2022 and the exercise price of the stock options. As of June 30, 2022, the total unrecognized compensation related to unvested stock option awards granted was $ 37.3 million, which the Company expects to recognize over a weighted-average period of approximately 3.1 years. No stock options were exercised during the period. 13 In March 2022, the Company announced a strategic reprioritization. As part of the reprioritization, the Company reduced its workforce by approximately 35 % (see Note 10). All outstanding unvested awards were forfeited upon each employee’s termination date, resulting in a forfeit of 713,540 awards in April 2022 and reversal of $ 0.8 million in stock-based compensation expense in April 2022. Restricted Stock Units On September 2, 2020, the Company issued 331,121 RSUs to an employee under the Existing Plan; 25 % of the shares of common stock underlying the RSUs vest at each anniversary over a four-year period. The RSUs are subject to a service-based vesting condition. The Company at any time may accelerate the vesting of the RSUs. Such shares are not accounted for as outstanding until they vest. As of June 30, 2022, the total unrecognized compensation related to unvested RSUs granted, including the remaining compensation cost associated with the RSUs granted on September 2, 2020 in exchange for the Cancelled Options, was $ 8.6 million which is expected to be amortized on a straight-line basis over a weighted-average period of approximately 2.0 years. The Company's default tax withholding method for RSUs is the sell-to-cover method, in which shares with a market value equivalent to the tax withholding obligation are sold on behalf of the holder of the RSUs upon vesting and settlement to cover the tax withholding liability and the cash proceeds from such sales are remitted by the Company to taxing authorities. The Company’s RSU activity for the six months ended June 30, 2022 was as follows: Weighted Average Grant Date Number Fair Value of Shares per Share Nonvested at December 31, 2021 1,886,765 $ 6.52 Restricted units granted — — Vested ( 546,141 ) 5.25 Cancelled or forfeited — — Nonvested at June 30, 2022 1,340,624 $ 7.04 Restricted Stock Awards RA Session II, the Company’s President and Chief Executive Officer, was awarded 769,058 RSAs under the Existing Plan on July 1, 2020, which are expected to vest over a three-year term, subject to continuous employment. As of June 30, 2022, the total unrecognized compensation related to unvested RSAs granted was $ 1.1 million which is expected to be amortized on a straight-line basis over a weighted-average period of approximately 0.8 years. The fair value of these RSAs at the grant date of July 1, 2020 was $ 5.28 per share. The Company’s RSA activity for the six months ended June 30, 2022 was as follows: Weighted Average Grant Date Number Fair Value of Shares per Share Nonvested at December 31, 2021 341,975 $ 5.28 Restricted stock granted — — Vested ( 128,240 ) 5.28 Nonvested at June 30, 2022 213,735 $ 5.28 Employee Stock Purchase Plan In February 2022, the Company’s board of directors authorized the first offering under the ESPP. Under the ESPP, eligible employees may purchase shares of Taysha common stock through payroll deductions at a price equal to 85 % of the lower of the fair market values of the stock as of the beginning or the end of six-month offering periods. An employee’s payroll deductions under the ESPP are limited to 15 % of the employee’s compensation and employees may not purchase more than 1,800 of shares of Taysha common stock during any offering period. During the six months ended June 30, 2022, stock-based compensation expense related to the ESPP was not material. 14 During the six months ended June 30, 2022, $ 0.2 million of stock-based compensation expense was capitalized as part of construction in process (see Note 3). The following table summarizes the total stock-based compensation expense for the stock options, ESPP, RSAs and RSUs recorded in the condensed consolidated statements of operations for the three and six months ended June 30, 2022 and 2021 (in thousands): For the Three Months Ended June 30, For the Six Months Ended June 30, 2022 2021 2022 2021 Research and development expense $ 1,316 $ 2,214 $ 3,893 $ 3,793 General and administrative expense 2,825 2,335 5,577 4,350 Total $ 4,141 $ 4,549 $ 9,470 $ 8,143 Note 7—Net Loss Per Common Share Basic net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding for the period. Since the Company had a net loss in all periods presented, basic and diluted net loss per common share are the same. The following table represents the calculation of basic and diluted net loss per common share (in thousands, except share and per share data): For the Three Months Ended June 30, For the Six Months Ended June 30, 2022 2021 2022 2021 Net loss $ ( 33,873 ) $ ( 40,926 ) $ ( 83,984 ) $ ( 72,950 ) Weighted-average shares of common stock outstanding used to compute net loss per common share, basic and diluted 40,142,403 37,479,164 39,163,996 37,237,115 Net loss per common share, basic and diluted $ ( 0.84 ) $ ( 1.09 ) $ ( 2.14 ) $ ( 1.96 ) The following common stock equivalents outstanding as of June 30, 2022 and 2021 were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been anti‑dilutive: June 30, 2022 June 30, 2021 Unvested RSUs 1,340,624 2,053,137 Unvested RSAs 213,735 470,215 Stock options 5,148,695 3,213,692 Total 6,703,054 5,737,044 Note 8—Income Taxes Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are provided if based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets. There is no provision for income taxes because the Company has incurred operating losses and capitalized certain items for income tax purposes since its inception and maintains a full valuation allowance against its net deferred tax assets. The reported amount of income tax expense for the period differs from the amount that would result from applying the federal statutory tax rate to net loss before taxes primarily because of the change in valuation allowance. 15 As of June 30, 2022, there were no material changes to either the nature or the amounts of the uncertain tax positions previously determined for the year ended December 31, 2021. Note 9—Commitments and Contingencies Litigation The Company is not a party to any material legal proceedings and is not aware of any pending or threatened claims. From time to time, the Company may be subject to various legal proceedings and claims that arise in the ordinary course of its business activities. Commitments In the normal course of business, the Company enters into contracts that contain a variety of indemnifications with its employees, licensors, suppliers and service providers. The Company’s maximum exposure under these arrangements is unknown at June 30, 2022. The Company does not anticipate recognizing any significant losses relating to these arrangements. Total lease expense, inclusive of lease incentives, under all operating lease agreements amounted to $ 0.3 million and $ 0.1 million for the three months ended June 30, 2022 and 2021, respectively, and $ 0.6 million and $ 0.1 million for the six months ended June 30, 2022 and 2021, respectively. Durham Lease On December 17, 2020, the Company entered into a lease agreement (the “Durham Lease”) with Patriot Park Partners II, LLC, a Delaware limited liability company (the “Durham Landlord”), pursuant to which the Company agreed to lease approximately 187,500 square feet of a manufacturing facility located at 5 National Way, Durham, North Carolina (the “Facility”). The Durham Lease commenced on April 1, 2021 and is expected to have a term of approximately fifteen years and six months . The Company has two options to extend the term of the Durham Lease, each for a period of an additional five years . The Company was not required to provide a security deposit in connection with its entry into the Durham Lease. The Company is responsible for constructing interior improvements within the Facility. The Company was required to place $ 2.6 million in an escrow account which will be released when the improvements are substantially complete. The escrow funds are recorded as restricted cash on the condensed consolidated balance sheet as of June 30, 2022. The Durham Landlord has the right to terminate the Durham Lease upon specified events of default, including the Company’s failure to pay rent in a timely manner and upon the occurrence of certain events of insolvency with respect to the Company. The Company incurred initial direct costs to enter into the Durham Lease of approximately $ 0.8 million. The costs have been recorded on the condensed consolidated balance sheets as a deferred lease asset and are being amortized into earnings over the term of the Durham Lease. In accordance with ASC Topic 840, Leases , the Company is deemed, for accounting purposes only, to be the owner of the entire leased Facility, including the building shell, during the construction period because of the Company’s expected level of direct financial and operational involvement in the substantial tenant improvements, including structural improvements, required to build out the Facility. As a result, the Company capitalized approximately $ 26.3 million as a build-to-suit asset within property, plant and equipment, net and recognized a corresponding build-to-suit lease financing obligation as a liability on its condensed consolidated balance sheets equal to the fair value of the existing building shell using comparable market prices per square foot for similar space for public real estate transactions in the surrounding area at commencement of construction in April 2020. Additionally, construction costs incurred as part of the build-out and tenant improvements are also capitalized within property, plant and equipment, net. Costs of approximately $ 10.6 million have been capitalized during the six months ended June 30, 2022, related to both equipment purchases and the build-out of the leased Facility, as well as capitalization of interest and certain payroll and payroll-related costs. The Company will assess and determine if the build-to-suit asset and corresponding liability should be de-recognized upon completion of construction. 16 Note 10 – Strategic Reprioritization In March 2022, the Company implemented changes to the Company’s organizational structure as well as a broader operational cost reduction plan to enable the Company to focus on specific clinical-stage programs for GAN and Rett syndrome. The Company will conduct small proof-of-concept studies in CLN1 disease and SLC13A5 deficiency. Development of the CLN7 program will continue in collaboration with existing partners with future clinical development to focus on the first-generation construct. Substantially all other research and development activities have been paused to increase operational efficiency. In connection with prioritization of programs, the Company reduced headcount by approximately 35 % across all functions. In accordance with ASC 420, Exit and Disposal Activities, the Company recorded one-time severance and termination-related costs of $ 2.6 million in the condensed consolidated statements of operations for the six months ended June 30, 2022, primarily within research and development expenses. Payments of accrued severance and termination-related costs are substantially complete as of June 30, 2022. Note 11 – Retirement Plan In July 2021, the Company adopted a 401(k) retirement savings plan that provides retirement benefits to all full-time employees. Eligible employees may contribute a percentage of their annual compensation, subject to Internal Revenue Service limitations. The Company contributed $ 0.1 million and $ 0.6 million to the 401(k) retirement savings plan for the three and six months ended June 30, 2022, respectively. 17