Financial Performance - The company has incurred a net loss of $20.9 million for the nine months ended September 30, 2023, compared to a net loss of $80.9 million for the same period in 2022, indicating a significant improvement [131]. - The company reported a net income of $20.9 million for the nine months ended September 30, 2023, compared to a net loss of $80.9 million for the same period in 2022, an improvement of $101.8 million [151]. - As of September 30, 2023, the company has an accumulated deficit of $468.5 million, reflecting ongoing financial challenges [131]. Expenses - The total operating expenses for the three months ended September 30, 2023, were $21.1 million, down from $23.0 million in the same period in 2022 [145]. - General and administrative expenses were $18.7 million for the nine months ended September 30, 2023, compared to $26.1 million for the same period in 2022, a decrease of $7.4 million [153]. - Total operating expenses decreased to $62.0 million for the nine months ended September 30, 2023, from $80.2 million for the same period in 2022, a reduction of $18.1 million [151]. - The company anticipates continued increases in general and administrative expenses due to costs associated with being a public company and exploring strategic alternatives [141]. Research and Development - The total research and development expenses for the three months ended September 30, 2023, were $14.8 million, a decrease of $1.1 million from $15.9 million in the same period in 2022 [145]. - Research and development expenses decreased by approximately $10.7 million to $43.3 million for the nine months ended September 30, 2023, from $54.0 million for the same period in 2022 [152]. - The company has terminated all treatment-related and long-term follow-up clinical studies for its Gaucher disease and Fabry disease programs as part of its strategic review [129]. - The company currently has three gene therapy product candidates, none of which are in active clinical development as of the filing date [129]. - The company has halted the development of its gene therapy programs and is exploring strategic alternatives, including potential acquisitions or mergers [128]. Cash Flow and Liquidity - Cash and cash equivalents as of September 30, 2023, were $105.8 million, indicating a strong liquidity position [165]. - Net cash used in operating activities was $55.2 million for the nine months ended September 30, 2023, compared to $73.5 million for the same period in 2022, reflecting improved cash flow management [168]. - Net cash provided by investing activities was $84.9 million for the nine months ended September 30, 2023, compared to cash used of $0.3 million for the same period in 2022, primarily due to the sale of the cystinosis program [169]. - Net cash used by financing activities was $16.1 million for the nine months ended September 30, 2023, compared to cash provided of $0.2 million for the same period in 2022, primarily due to the repayment of the Term Loan Agreement [170]. Other Income and Gains - The company recognized a gain on asset sale of $83.7 million for the nine months ended September 30, 2023, net of $3.8 million in transaction costs [154]. - Interest income for the three months ended September 30, 2023, was $1.4 million, a significant increase from $111,000 in the same period in 2022 [145]. - Other income, net, was $1.1 million for the nine months ended September 30, 2023, compared to $(0.7) million for the same period in 2022, primarily due to the elimination of interest expense related to the Term Loan Agreement [156]. Future Outlook - The company expects substantial increases in expenses if product development resumes, particularly for clinical trials and preclinical studies, as well as for hiring additional personnel and expanding infrastructure [171]. - The company plans to finance cash needs through equity offerings, debt financings, collaboration agreements, and other funding sources, which may involve relinquishing rights to technologies or revenue streams [172]. Foreign Currency Exposure - Foreign currency transaction losses were $116 thousand for the nine months ended September 30, 2023, compared to $70 thousand for the same period in 2022, primarily due to transactions in currencies other than the U.S. dollar [179]. - The company has not entered into any foreign currency hedging contracts to mitigate exposure to foreign currency exchange risk [180].

Financial Performance - The company has not generated any product revenue to date and has incurred significant operating losses, with a net loss of $42.5 million for the six months ended June 30, 2023, compared to a net loss of $57.9 million for the same period in 2022[125]. - The company has an accumulated deficit of $446.9 million as of June 30, 2023[125]. - Net income for Q2 2023 was $67.5 million, a significant increase of $95.5 million compared to a net loss of $28.1 million in Q2 2022[142]. - For the six months ended June 30, 2023, total operating expenses decreased to $40.9 million from $57.2 million in the same period of 2022, reflecting a reduction of $16.2 million[149]. Cash and Funding - As of June 30, 2023, the company had cash and cash equivalents of $124.7 million, which is expected to fund operations at least into the fourth quarter of 2024[129]. - The company has received gross cash proceeds of $428.1 million from sales of common stock through its initial public offering and follow-on offerings[124]. - The company may need substantial additional funding to support operations and pursue growth strategies, relying on external sources for financing[126]. - The company repaid all outstanding amounts under the Term Loan Agreement in Q2 2023, resulting in a net cash used by financing activities of $16.3 million for the six months ended June 30, 2023[164]. - Operating activities used $34.9 million of cash for the six months ended June 30, 2023, compared to $57.1 million in the same period of 2022, reflecting improved cash flow management[162]. Research and Development - Research and development expenses totaled $11.1 million for the three months ended June 30, 2023, a decrease from $18.9 million for the same period in 2022[134]. - The company has incurred research and development expenses related to various programs, with significant costs expected to increase if development resumes[134]. - Research and development expenses decreased by approximately $7.7 million to $11.1 million for Q2 2023, down from $18.9 million in Q2 2022, driven by reductions in development, manufacturing, and personnel-related costs[143]. - The company is focused on three HSC gene therapy programs, with AVR-RD-02 in a Phase 1/2 clinical trial for Gaucher disease type 1 and type 3[122]. Strategic Plans - The company plans to halt development of its programs and explore strategic alternatives, which may include acquisitions or mergers[122]. - The company anticipates increased general and administrative expenses due to exploration of potential strategic alternatives and preparation for commercial operations[139]. - The company plans to expand its infrastructure and hire additional personnel to support product development and commercialization[166]. - The company expects to incur significant commercialization expenses if regulatory approval for product candidates is obtained[166]. Currency and Accounting - Foreign currency transaction losses for the six months ended June 30, 2023, were $65,000, compared to $40,000 for the same period in 2022[174]. - The company has not entered into foreign currency hedging contracts to mitigate exchange rate risks[175]. - A 10% change in exchange rates is not expected to materially impact the company's financial position[174]. - There were no material changes to the company's critical accounting policies during the six months ended June 30, 2023[169]. - The company is classified as an "emerging growth company" and may take advantage of certain reporting exemptions until it no longer qualifies[170].

Financial Performance - The company reported net losses of $25.0 million for the three months ended March 31, 2023, compared to $29.8 million for the same period in 2022, resulting in an accumulated deficit of $514.4 million as of March 31, 2023[121]. - Net loss for the three months ended March 31, 2023, was $24.96 million, an improvement of $4.88 million compared to a net loss of $29.83 million for the same period in 2022[140]. - Net cash used in operating activities was $20.3 million for the three months ended March 31, 2023, compared to $28.0 million for the same period in 2022[149]. - Total other income (expense), net, was $0.3 million for the three months ended March 31, 2023, compared to $(0.4) million for the same period in 2022, primarily due to increased interest income[140]. Funding and Cash Position - The company has raised a total of $428.1 million from sales of common stock through its initial public offering and follow-on offerings, along with $87.5 million from preferred stock sales[120]. - As of March 31, 2023, the company had cash and cash equivalents of $72.3 million, expected to fund operations into the first quarter of 2024[125]. - Cash and cash equivalents as of March 31, 2023, were $72.3 million, expected to fund operating expenses into the first quarter of 2024[146]. - As of March 31, 2023, approximately $26.5 million of common stock remained available for future issuance under the ATM facility[144]. - The company has drawn $15.0 million in term loans under its Term Loan Agreement, with a repayment schedule starting November 1, 2024[145]. Research and Development - The total research and development expenses for the three months ended March 31, 2023, were $17.3 million, a decrease from $19.3 million in the same period of 2022[129]. - Research and development expenses decreased by approximately $1.9 million to $17.3 million for the three months ended March 31, 2023, from $19.3 million for the same period in 2022[138]. - The company is currently focused on four HSC gene therapy programs targeting rare diseases, with significant market opportunities estimated at approximately $3.5 billion in worldwide net sales in 2022[116]. - AVR-RD-02 is in a Phase 1/2 clinical trial for Gaucher disease type 1, with five patients dosed and six enrolled as of March 20, 2023, and a global Phase 2/3 trial planned for the second half of 2023[118]. - The company plans to initiate a Phase 1/2 clinical trial for AVR-RD-04 for cystinosis in the second half of 2023, following the completion of enrollment in a collaborator-sponsored trial[119]. - The company expects expenses to increase substantially as it advances preclinical activities and clinical trials of its product candidates[152]. Operating Expenses - The company anticipates significant increases in general and administrative expenses as it expands headcount and prepares for potential commercialization of its product candidates[134]. - General and administrative expenses were $7.9 million for the three months ended March 31, 2023, compared to $10.2 million for the same period in 2022, a decrease of $2.3 million[139]. - The company has incurred significant operating losses and will require substantial additional funding to support ongoing operations and growth strategies[123]. Currency and Interest Rate Exposure - The company recognized foreign currency transaction losses of $28 thousand and $46 thousand for the three months ended March 31, 2023, and 2022, respectively[161]. - The company believes that a 10% change in the exchange rate between the U.S. dollar and other currencies would not have a material impact on its financial position or results of operations[161]. - The company has not entered into any foreign currency hedging contracts to mitigate exposure to foreign currency exchange risk[162]. - An immediate 100 basis point change in interest rates would not have a material effect on the fair market value of the company's investment portfolio due to its short-term duration and low risk profile[160].

Financial Performance - The company incurred net losses of $105.9 million and $119.1 million for the years ended December 31, 2022, and 2021, respectively[236]. - As of December 31, 2022, the company had cash and cash equivalents of $92.6 million, expected to fund operations into the first quarter of 2024[242]. - The company may need to consider strategic alternatives, including mergers or liquidation, if unable to raise adequate capital[239]. - The company has federal and state net operating loss carryforwards of $340.4 million and $313.0 million as of December 31, 2022, and 2021, respectively[425]. - Federal research and development tax credit carryforwards amount to approximately $6.8 million and $6.2 million for the years ending December 31, 2022, and 2021, respectively[425]. Product Development and Clinical Trials - The company has a total of four gene therapy programs in its pipeline, with two currently in clinical development[244]. - The company has only dosed ten patients using its plato platform in clinical trials, including six patients in the halted FAB-GT clinical trial[265]. - The ongoing Phase 1/2 clinical trial of AVR-RD-04 is being conducted by collaborators at the University of California, San Diego, while the planned Phase 1/2 clinical trial of AVR-RD-05 has received acceptance for its CTA application from the MHRA[283]. - The company has dosed only 24 patients in its clinical trials, including 14 patients from the Fabry program that was deprioritized in January 2022[279]. - The company expects to enroll up to ten patients by the end of 2023 in the Guard1 clinical trial for Gaucher disease type 1, but there are no assurances this goal will be met[291]. Regulatory and Compliance Challenges - The regulatory approval process for the company's novel product candidates may be more expensive and time-consuming compared to better-known therapies[266]. - The FDA has indicated that patients treated with gene therapies should undergo long-term follow-up observation for potential adverse events for up to 15 years[272]. - Regulatory authorities may require a Risk Evaluation and Mitigation Strategy (REMS) if any product candidates receive marketing approval, which could include additional warnings and restrictions[277]. - The company has limited experience in preparing and submitting regulatory filings, having never completed a pivotal or registrational clinical trial[278]. - The FDA established the Office of Therapeutic Products (OTP) to enhance review capabilities for gene therapy products, but the impact on time and costs for regulatory approval remains uncertain[271]. Manufacturing and Supply Chain Risks - The company may face production problems due to the complexity of gene therapies, which could lead to delays in development or commercialization[336]. - Manufacturing processes are complex and may result in product defects or recalls if not strictly controlled, impacting inventory and financial performance[337]. - The company relies on third parties for vector production and clinical testing, which may lead to reduced control and potential delays in product development[339]. - The ongoing COVID-19 pandemic and geopolitical factors, such as the war in Ukraine, may cause delays in production and supply[350]. - The company relies on sole source suppliers for critical components, including automated closed cell processing systems, vector supply, plasmid supply, and drug product manufacturing for clinical trials[345]. Market and Competitive Landscape - The company faces significant competition from larger pharmaceutical and biotechnology companies, which may have more advanced therapies and greater resources[306]. - Competitors such as Sanofi, Pfizer, and Takeda currently market established therapies for conditions like Gaucher disease, which the company is targeting[307]. - The commercial success of product candidates is uncertain and may be adversely affected if market opportunities are smaller than anticipated[365]. - Market acceptance of the company's product candidates will depend on factors such as efficacy, safety, pricing, and the willingness of healthcare providers to prescribe the treatments[366]. Human Resources and Organizational Challenges - The company’s success depends on the ability to retain key employees and attract new talent, which is critical for ongoing operations and development[391]. - The company implemented a reduction in force in January 2022, deprioritizing the Fabry disease program, and continued to streamline employee headcount through the first half of 2022[392]. - The company faces intense competition for skilled personnel in gene therapy research and vector manufacturing, which may impede recruitment and retention efforts[392]. - The company restructured its organization in January 2022, significantly reducing its workforce to conserve capital resources, which may lead to unintended attrition and reduced employee morale[399]. Legal and Compliance Risks - Compliance with healthcare laws and regulations is critical, as violations could result in substantial penalties, including fines and exclusion from federal healthcare programs[404]. - The company is subject to various federal and state fraud and abuse laws, which will impact clinical trial programs and healthcare professional interactions[404]. - The company may face substantial fines for violations of the GDPR, which can be up to 4% of global revenues or €20 million (£17.5 million), whichever is greater[414]. - The company must comply with stringent data protection laws, and failure to do so could result in government enforcement actions and adverse publicity[410]. Financial and Market Access Challenges - The uncertainty regarding insurance coverage and reimbursement for newly approved products could limit the company's ability to market those products and decrease revenue generation[373]. - The company faces significant pricing pressures due to cost containment trends in the U.S. healthcare industry and extensive governmental price controls in international markets[375]. - Legislative changes, such as the Inflation Reduction Act of 2022, may impose new financial liabilities and affect pricing negotiations for the company's products[384]. - The company may experience delays in product approvals due to inadequate funding for the FDA and other regulatory agencies[385].

March 2023 Arianna living with Gaucher disease type 3 1 Disclaimer This presentation has been prepared by AVROBIO, Inc. (“AVROBIO”) clinical trial results, and product approvals; the timing and results of results, such as signals of safety, activity, or durability of effect, for informational purposes only and not for any other purpose. Certain our ongoing preclinical studies; the anticipated benefits of our gene observed from preclinical or clinical trials, will not be replicated or information contained i ...

PART I. FINANCIAL INFORMATION This section provides the unaudited condensed consolidated financial statements and management's discussion and analysis for the period [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) This section presents the unaudited condensed consolidated financial statements of AVROBIO, Inc. for the period ended March 31, 2022, including balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity, and statements of cash flows, along with detailed notes explaining the company's business, accounting policies, license agreements, and financial position [Balance Sheets](index=7&type=section&id=Balance%20Sheets) This section presents the company's financial position, including assets, liabilities, and equity, as of specific dates Balance Sheet Summary | Metric | March 31, 2022 (in thousands) | December 31, 2021 (in thousands) | | :----- | :---------------------------- | :------------------------------- | | Total Assets | $175,343 | $203,837 | | Total Liabilities | $32,180 | $34,361 | | Total Stockholders' Equity | $143,163 | $169,476 | | Cash and Cash Equivalents | $161,663 | $189,567 | [Statements of Operations and Comprehensive Loss](index=8&type=section&id=Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's financial performance, including revenues, expenses, and net loss, over specific periods Statements of Operations Summary | Metric | Three Months Ended March 31, 2022 (in thousands) | Three Months Ended March 31, 2021 (in thousands) | Change (YoY) | | :----- | :----------------------------------------------- | :----------------------------------------------- | :----------- | | Research and Development | $19,253 | $18,527 | +$726 | | General and Administrative | $10,165 | $8,357 | +$1,808 | | Total Operating Expenses | $29,418 | $26,884 | +$2,534 | | Net Loss | $(29,833) | $(26,899) | $(2,934) | | Net Loss Per Share (Basic and Diluted) | $(0.68) | $(0.65) | $(0.03) | [Statements of Stockholders' Equity](index=9&type=section&id=Statements%20of%20Stockholders%27%20Equity) This section outlines changes in the company's equity accounts, including common stock and accumulated deficit, over specific periods Stockholders' Equity Summary | Metric | March 31, 2022 (in thousands) | December 31, 2021 (in thousands) | | :----- | :---------------------------- | :------------------------------- | | Common Stock | $4 | $4 | | Additional Paid-in Capital | $556,534 | $553,014 | | Accumulated Deficit | $(413,375) | $(383,542) | | Total Stockholders' Equity | $143,163 | $169,476 | - **Stock-based compensation expense** for the three months ended March 31, 2022, was **$3,378 thousand**, and **$4,635 thousand** for the same period in 2021[24](index=24&type=chunk) [Statements of Cash Flows](index=10&type=section&id=Statements%20of%20Cash%20Flows) This section reports the cash inflows and outflows from operating, investing, and financing activities over specific periods Cash Flow Summary | Metric | Three Months Ended March 31, 2022 (in thousands) | Three Months Ended March 31, 2021 (in thousands) | | :----- | :----------------------------------------------- | :----------------------------------------------- | | Net Cash Used in Operating Activities | $(28,014) | $(27,339) | | Net Cash Used in Investing Activities | $(32) | $(115) | | Net Cash Provided by Financing Activities | $142 | $799 | | Net Decrease in Cash, Cash Equivalents and Restricted Cash | $(27,904) | $(26,655) | | Cash, Cash Equivalents and Restricted Cash at End of Period | $162,155 | $233,519 | [Notes to Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements [1. Nature of the Business](index=11&type=section&id=1.%20Nature%20of%20the%20Business) This note describes AVROBIO's core business as a clinical-stage gene therapy company and its financial viability - AVROBIO is a **clinical-stage gene therapy company** focused on developing potentially **curative ex vivo lentiviral gene therapies** to treat **rare diseases** following a **single dose treatment regimen**[29](index=29&type=chunk) - The company has incurred **recurring net losses since inception**, including **$29.8 million** for the three months ended March 31, 2022, and had an **accumulated deficit of $413.4 million** as of March 31, 2022[31](index=31&type=chunk) - Existing cash and cash equivalents of **$161.7 million** as of March 31, 2022, are expected to fund current planned operations and capital expenditure requirements for **at least the next twelve months**, but **future viability depends on raising additional capital**[31](index=31&type=chunk) [2. Summary of Significant Accounting Policies](index=11&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and methods used in preparing the financial statements - The unaudited condensed consolidated financial statements are **prepared in conformity with GAAP** and reflect all necessary adjustments for fair presentation[32](index=32&type=chunk)[33](index=33&type=chunk) - The company operates and manages its business as **one operating segment**, with all material long-lived assets residing in the United States[37](index=37&type=chunk) - As an **'emerging growth company' (EGC)**, AVROBIO has elected to use the **extended transition period for complying with new or revised accounting standards**[46](index=46&type=chunk) [3. License Agreements](index=14&type=section&id=3.%20License%20Agreements) This note details the company's exclusive worldwide license agreements for various gene therapy programs - The company holds an **exclusive worldwide license** from The University of Manchester for an ex vivo lentiviral gene therapy for Hunter syndrome (MPSII), with **potential milestone payments up to $80 million** and **mid-single digit royalties**. Incurred **$963 thousand** related to collaborative research funding in Q1 2022[53](index=53&type=chunk)[54](index=54&type=chunk)[56](index=56&type=chunk) - AVROBIO has an **exclusive worldwide license** from University Health Network (UHN) for Fabry disease, incurring **$24 thousand** in R&D expense in Q1 2022. Another **exclusive license** with UHN for Interleukin 12 patent rights incurred no R&D expense in Q1 2022[57](index=57&type=chunk)[60](index=60&type=chunk)[63](index=63&type=chunk)[65](index=65&type=chunk) - The company also holds **exclusive worldwide licenses** for Pompe disease (from BioMarin Pharmaceutical Inc.), cystinosis (from Papillon Therapeutics, Inc.), and Gaucher disease (from Lund University Rights Holders), with no related expenses recognized in Q1 2022 for these agreements[66](index=66&type=chunk)[67](index=67&type=chunk)[70](index=70&type=chunk)[71](index=71&type=chunk)[72](index=72&type=chunk)[73](index=73&type=chunk) [4. Fair Value Measurement](index=17&type=section&id=4.%20Fair%20Value%20Measurement) This note provides information on the fair value of financial instruments, particularly cash equivalents Fair Value Measurement Details | Asset | March 31, 2022 (in thousands) | December 31, 2021 (in thousands) | | :---- | :---------------------------- | :------------------------------- | | Cash equivalents — money market funds | $160,512 | $189,332 | - The **fair value of cash equivalents was determined through quoted prices by third-party pricing services (Level 1 inputs)**[77](index=77&type=chunk) [5. Supplemental Balance Sheet Information](index=18&type=section&id=5.%20Supplemental%20Balance%20Sheet%20Information) This note offers additional details on specific balance sheet accounts, such as prepaid expenses and accrued liabilities Supplemental Balance Sheet Details | Category | March 31, 2022 (in thousands) | December 31, 2021 (in thousands) | | :------- | :---------------------------- | :------------------------------- | | Prepaid expenses and other current assets | $9,258 | $9,578 | | Property and equipment, net | $3,867 | $4,126 | | Restricted cash | $492 | $492 | | Accrued expenses and other current liabilities | $12,879 | $15,638 | [6. Commitments and Contingencies](index=19&type=section&id=6.%20Commitments%20and%20Contingencies) This note discloses the company's contractual obligations, potential legal proceedings, and indemnification agreements - The company was **not subject to any material legal proceedings** during the three months ended March 31, 2022 and 2021, and no material legal proceedings are currently pending or threatened[85](index=85&type=chunk) - AVROBIO is party to various agreements requiring future milestone and royalty payments, and enters into **standard indemnification agreements with unknown maximum exposure**, but **does not anticipate significant losses**[86](index=86&type=chunk) [7. Note Payable](index=19&type=section&id=7.%20Note%20Payable) This note describes the terms and conditions of the company's term loan agreement and related obligations - In November 2021, the company entered into a **Term Loan Agreement** for up to **$50 million**, with **$15 million** advanced on the closing date. The **$20 million Milestone Funding tranche is no longer available** due to the **deprioritization of the Fabry program**[87](index=87&type=chunk)[149](index=149&type=chunk) - The note payable, net of discount, was **$15,020 thousand** as of March 31, 2022. The **loan bears interest at the greater of Prime Rate + 4.85% or 8.10%**, with an **effective interest rate of approximately 11.12%**[88](index=88&type=chunk)[90](index=90&type=chunk)[91](index=91&type=chunk) - **Interest-only payments are required through November 1, 2024**, followed by **principal and interest installments through October 1, 2026**. An **end-of-term charge of 9.00%** of the aggregate principal amount is due upon repayment[88](index=88&type=chunk)[89](index=89&type=chunk) [8. Stockholders' Equity](index=21&type=section&id=8.%20Stockholders%27%20Equity) This note provides details on the company's authorized and outstanding shares, and shares reserved for future issuance - As of March 31, 2022, the company had **150,000,000 authorized common shares** and **10,000,000 undesignated preferred shares**, with **no preferred stock outstanding**. **No cash dividends have been declared or paid**[95](index=95&type=chunk) Shares Reserved for Future Issuance | Shares Reserved for Future Issuance | March 31, 2022 | December 31, 2021 | | :---------------------------------- | :------------- | :---------------- | | Exercise of outstanding stock options | 9,471,305 | 7,423,777 | | Vesting of restricted stock units | 919,853 | 599,850 | | Issuance under 2018 Stock Option and Grant Plan | 1,777,657 | 2,583,736 | | Issuance under 2018 Employee Stock Purchase Plan | 1,544,308 | 1,151,010 | | Issuance under 2019 Inducement Plan | 573,944 | 412,686 | | Issuance under 2020 Inducement Plan | 1,637,000 | 1,637,000 | | Total shares reserved | 15,924,067 | 13,808,059 | [9. Stock-based Compensation](index=21&type=section&id=9.%20Stock-based%20Compensation) This note explains the accounting for stock-based awards and the related compensation expense recognized Stock-based Compensation Expense | Stock-based Compensation Expense | Three Months Ended March 31, 2022 (in thousands) | Three Months Ended March 31, 2021 (in thousands) | | :------------------------------- | :----------------------------------------------- | :----------------------------------------------- | | Research and development | $939 | $2,115 | | General and administrative | $2,439 | $2,520 | | Total | $3,378 | $4,635 | - The **weighted-average grant-date fair value of stock options granted decreased** from **$10.69** in Q1 2021 to **$1.29** in Q1 2022[102](index=102&type=chunk) - As of March 31, 2022, **total unrecognized compensation cost related to unvested stock-based awards** was **$34,360 thousand**, expected to be recognized over a **weighted-average period of 2.78 years**[107](index=107&type=chunk) [10. Net Loss Per Share](index=23&type=section&id=10.%20Net%20Loss%20Per%20Share) This note details the calculation of basic and diluted net loss per share for the reporting periods - Basic and diluted net loss per share was **$(0.68)** for the three months ended March 31, 2022, compared to **$(0.65)** for the same period in 2021[20](index=20&type=chunk) - **Potentially dilutive common stock equivalents**, including **9,471,305 options** and **919,853 restricted stock units** as of March 31, 2022, were **excluded from the diluted net loss per share calculation as their effect would be anti-dilutive**[108](index=108&type=chunk)[109](index=109&type=chunk) [11. Related Party Transactions](index=23&type=section&id=11.%20Related%20Party%20Transactions) This note discloses transactions with entities or individuals considered related parties to the company - The company recognized **$24 thousand** in research and development expense related to license agreements with University Health Network (UHN) for the three months ended March 31, 2022, down from **$39 thousand** in the prior year[110](index=110&type=chunk) - Expenses of **$794 thousand** were recorded for a sublease to rent lab space from an entity affiliated with a board member for the three months ended March 31, 2022, an increase from **$641 thousand** in the prior year[111](index=111&type=chunk) [12. Restructuring Activities](index=23&type=section&id=12.%20Restructuring%20Activities) This note describes the company's restructuring efforts, including program deprioritization and workforce reductions - In January 2022, AVROBIO **deprioritized its AVR-RD-01 Fabry disease program** due to **new clinical data showing variable engraftment patterns and a challenging market/regulatory environment**[112](index=112&type=chunk) - A **workforce reduction of approximately 23%** was approved, resulting in **total restructuring expenses of $1,369 thousand** for the three months ended March 31, 2022, **primarily for employee termination benefits**[112](index=112&type=chunk)[115](index=115&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on AVROBIO's financial condition and operational results for the three months ended March 31, 2022, highlighting the company's focus on clinical-stage gene therapies for rare diseases, its financial performance, liquidity, and future funding requirements, including the impact of the Fabry program deprioritization and workforce reduction [Overview](index=25&type=section&id=Overview) This section provides a high-level summary of AVROBIO's business, pipeline, and financial performance - AVROBIO is a **clinical-stage gene therapy company** focused on developing potentially **curative ex vivo lentiviral-based gene therapies** for **rare diseases**, particularly lysosomal disorders[118](index=118&type=chunk) - The company's pipeline includes **five lentiviral-based gene therapy programs**: AVR-RD-04 (cystinosis), AVR-RD-02 (Gaucher disease type 1), AVR-RD-05 (Hunter syndrome), AVR-RD-06 (Gaucher disease type 3), and AVR-RD-03 (Pompe disease)[119](index=119&type=chunk) - AVROBIO has incurred **significant operating losses since inception**, with a net loss of **$29.8 million** for Q1 2022 and an **accumulated deficit of $413.4 million** as of March 31, 2022[124](index=124&type=chunk)[125](index=125&type=chunk) - Existing cash and cash equivalents of **$161.7 million** are projected to fund operating expenses and capital expenditure requirements **into the first quarter of 2024**, but **substantial additional funding will be needed**[128](index=128&type=chunk) [Components of Our Consolidated Results of Operations](index=26&type=section&id=Components%20of%20Our%20Consolidated%20Results%20of%20Operations) This section breaks down the key components contributing to the company's consolidated financial results [Operating Expenses](index=26&type=section&id=Operating%20Expenses) This section details the company's research and development and general and administrative expenses [Research and Development Expenses](index=26&type=section&id=Research%20and%20Development%20Expenses) This section analyzes the trends and drivers of the company's research and development expenditures - Research and development expenses increased by approximately **$0.7 million** to **$19.3 million** for Q1 2022, from **$18.5 million** for Q1 2021, **primarily driven by a $1.8 million increase in clinical trial consulting expenses**[141](index=141&type=chunk) - The company expects R&D expenses to **increase substantially over the next several years** as product candidates advance through clinical development, requiring increased personnel, contractor, and facilities costs[132](index=132&type=chunk) [General and Administrative Expenses](index=28&type=section&id=General%20and%20Administrative%20Expenses) This section analyzes the trends and drivers of the company's general and administrative expenditures - General and administrative expenses increased by **$1.8 million** to **$10.2 million** for Q1 2022, compared to **$8.4 million** for Q1 2021[142](index=142&type=chunk) - This increase was **attributable to a $0.7 million rise in personnel-related costs (including severance from workforce reduction) and a $1.1 million increase in other expenses** (facilities, professional, and legal fees)[142](index=142&type=chunk) [Other (Expense) Income, Net](index=28&type=section&id=Other%20%28Expense%29%20Income%2C%20Net) This section details non-operating income and expenses, primarily interest expense - Other (expense), net, was **$(0.4) million** for Q1 2022, compared to less than **$(0.1) million** for Q1 2021, **primarily due to interest expense related to the Term Loan Agreement** entered in Q4 2021[143](index=143&type=chunk) [Consolidated Results of Operations](index=28&type=section&id=Consolidated%20Results%20of%20Operations) This section provides a comparative analysis of the company's consolidated operating results [Comparison of the three months ended March 31, 2022 and 2021](index=28&type=section&id=Comparison%20of%20the%20three%20months%20ended%20March%2031%2C%202022%20and%202021) This section compares the company's financial performance for the three-month periods ended March 31, 2022 and 2021 Operating Expense Comparison | Operating Expense | 2022 (in thousands) | 2021 (in thousands) | Change (in thousands) | | :---------------- | :------------------ | :------------------ | :-------------------- | | Research and Development | $19,253 | $18,527 | $726 | | General and Administrative | $10,165 | $8,357 | $1,808 | | Total Operating Expenses | $29,418 | $26,884 | $2,534 | | Loss from Operations | $(29,418) | $(26,884) | $(2,534) | | Total Other (Expense) Income, Net | $(415) | $(15) | $(400) | | Net Loss | $(29,833) | $(26,899) | $(2,934) | [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's ability to meet its short-term and long-term financial obligations and its funding sources - Since inception, AVROBIO has **funded operations primarily through sales of preferred stock ($87.5 million)**, **common stock through IPO and follow-on offerings ($428.1 million)**, **ATM facility sales ($23.5 million)**, and **$15.0 million from a term loan**[123](index=123&type=chunk)[144](index=144&type=chunk) - As of March 31, 2022, the company had **$161.7 million** in cash and cash equivalents, which are **expected to fund operating expenses and capital expenditure requirements into the first quarter of 2024**[128](index=128&type=chunk)[150](index=150&type=chunk) - The **$20.0 million Milestone Funding tranche under the Term Loan Agreement is no longer available** due to the **deprioritization of the Fabry disease program**[149](index=149&type=chunk) [Cash Flows](index=30&type=section&id=Cash%20Flows) This section analyzes the company's cash inflows and outflows from operating, investing, and financing activities Cash Flow Summary | Cash Flow Activity | Three Months Ended March 31, 2022 (in thousands) | Three Months Ended March 31, 2021 (in thousands) | | :----------------- | :----------------------------------------------- | :----------------------------------------------- | | Net cash used in operating activities | $(28,014) | $(27,339) | | Net cash used in investing activities | $(32) | $(115) | | Net cash provided by financing activities | $142 | $799 | | Net (decrease) in cash and cash equivalents | $(27,904) | $(26,655) | - The **decrease in cash provided by financing activities** in Q1 2022 was **primarily due to lower proceeds from stock option exercises** compared to Q1 2021, **partially offset by proceeds from ESPP shares**[155](index=155&type=chunk) [Funding Requirements](index=31&type=section&id=Funding%20Requirements) This section outlines the company's anticipated future capital needs and strategies for securing additional funding - Expenses are **expected to increase substantially** with ongoing preclinical activities, clinical trials, and potential commercialization efforts for product candidates[156](index=156&type=chunk) - The company anticipates **financing future cash needs through equity offerings, debt financings, collaboration agreements, and other third-party funding**, as **product revenue is not expected for several years**[158](index=158&type=chunk) [Contractual Obligations and Commitments](index=31&type=section&id=Contractual%20Obligations%20and%20Commitments) This section refers to disclosures regarding the company's long-term contractual obligations and commitments - Disclosure of contractual obligations and commitments is set forth in the Annual Report on Form 10-K for the fiscal year ended December 31, 2021[159](index=159&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=31&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) This section confirms no material changes to the company's critical accounting policies during the reporting period - There were **no material changes to the company's critical accounting policies** during the three months ended March 31, 2022[160](index=160&type=chunk) [Emerging Growth Company Status](index=32&type=section&id=Emerging%20Growth%20Company%20Status) This section explains the company's status as an emerging growth company and its election of certain exemptions - AVROBIO is an **'emerging growth company' (EGC)** and takes advantage of certain exemptions from reporting requirements, including an **extended transition period for new or revised accounting standards**[161](index=161&type=chunk) [Recently Issued Accounting Pronouncements](index=32&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) This section refers to disclosures regarding recently issued accounting pronouncements and their potential impact - A description of recently issued accounting pronouncements that may impact financial position and results of operations is disclosed in Note 2, 'Summary of Significant Accounting Policies'[162](index=162&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section discusses AVROBIO's exposure to market risks, specifically interest rate risk on its cash equivalents and foreign currency exchange risk from international operations, and the company's strategies for managing these risks [Interest Rate Risk](index=32&type=section&id=Interest%20Rate%20Risk) This section analyzes the company's exposure to interest rate fluctuations on its cash equivalents and debt obligations - AVROBIO's **primary exposure to market risk is interest rate sensitivity**, affecting its **$161.7 million** in cash and cash equivalents, primarily held in short-term money market funds[163](index=163&type=chunk) - Due to the **short-term duration and low-risk profile of its investment portfolio**, an **immediate 100 basis point change in interest rates would not materially affect the fair market value** of the portfolio[163](index=163&type=chunk) [Foreign Currency Exchange Risk](index=32&type=section&id=Foreign%20Currency%20Exchange%20Risk) This section discusses the company's exposure to foreign currency exchange rate fluctuations from international operations - The company is **exposed to foreign exchange rate risk** from research and development costs incurred by its Australian and Canadian subsidiaries in Australian and Canadian dollars, respectively[164](index=164&type=chunk) - **Foreign currency transaction losses of $46 thousand** were recognized for the three months ended March 31, 2022, compared to **$25 thousand** for the same period in 2021[164](index=164&type=chunk) - A **10% change in the exchange rate** between the U.S. dollar, Australian dollar, Great British Pound, and Canadian dollar is **not expected to have a material impact** on the company's financial position or results of operations[164](index=164&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details management's evaluation of the company's disclosure controls and procedures and reports on any changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=33&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section details management's assessment of the effectiveness of the company's disclosure controls and procedures - Management, with the participation of the CEO and CFO, evaluated the **effectiveness of disclosure controls and procedures as of March 31, 2022, and concluded they were effective at the reasonable assurance level**[167](index=167&type=chunk) [Changes in Internal Control over Financial Reporting](index=33&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section reports on any material changes in the company's internal control over financial reporting - **No change in internal control over financial reporting occurred** during the three months ended March 31, 2022, that materially affected, or is reasonably likely to materially affect, internal control over financial reporting[168](index=168&type=chunk) PART II. OTHER INFORMATION This section provides additional disclosures including legal proceedings, risk factors, and other required information [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) This section confirms the absence of any material legal proceedings against the company - As of March 31, 2022, AVROBIO was **not subject to any pending or threatened litigation that, if determined adversely, would reasonably be expected to have a material adverse effect on its business**[170](index=170&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) This section outlines the significant risks and uncertainties that could adversely affect AVROBIO's business, financial condition, and results of operations, covering aspects from financial viability and product development to manufacturing, commercialization, intellectual property, and stock ownership [Risks related to our business, financial position and need for additional capital](index=34&type=section&id=Risks%20related%20to%20our%20business%2C%20financial%20position%20and%20need%20for%20additional%20capital) This section highlights risks associated with the company's financial viability, ongoing losses, and future funding requirements - AVROBIO has incurred **net losses since inception** and expects to continue incurring losses for the foreseeable future, potentially **never achieving or maintaining profitability**[172](index=172&type=chunk)[174](index=174&type=chunk) - The company will need **substantial additional funding, which may not be available on acceptable terms**, potentially **forcing delays, limitations, or termination of product development efforts**[177](index=177&type=chunk)[180](index=180&type=chunk) - The **Term Loan Agreement contains restrictions limiting operational flexibility**, and the **$20.0 million Milestone Funding tranche is no longer available** due to the **deprioritization of the Fabry program**[181](index=181&type=chunk)[182](index=182&type=chunk) [Risks related to the discovery and development of our product candidates](index=37&type=section&id=Risks%20related%20to%20the%20discovery%20and%20development%20of%20our%20product%20candidates) This section outlines risks inherent in the discovery, development, and regulatory approval of the company's gene therapy product candidates - The **ongoing COVID-19 pandemic has caused and may continue to cause disruptions to clinical trial programs**, clinical supply, and business operations, impacting patient enrollment and data collection[187](index=187&type=chunk)[188](index=188&type=chunk)[189](index=189&type=chunk)[191](index=191&type=chunk) - **Lentiviral-based gene therapy is a novel technology**, making it **difficult to predict the time and cost of product candidate development and regulatory approval**, which can be **more expensive and lengthy**[193](index=193&type=chunk)[194](index=194&type=chunk) - Product candidates and their administration process may cause **undesirable side effects, including delayed adverse events**, which could **delay or prevent regulatory approval, limit commercial potential, or result in significant negative consequences**[199](index=199&type=chunk)[200](index=200&type=chunk)[201](index=201&type=chunk)[203](index=203&type=chunk)[204](index=204&type=chunk) - **Success in preclinical studies or early clinical trials may not be indicative of later trial results**; the **deprioritization of the Fabry program due to variable engraftment patterns in later-stage patients highlights this risk**[211](index=211&type=chunk) - **Difficulty enrolling patients in clinical trials, especially for rare diseases and international patients**, could **delay or prevent the progression of product candidates**[217](index=217&type=chunk)[218](index=218&type=chunk)[219](index=219&type=chunk)[221](index=221&type=chunk)[222](index=222&type=chunk) - The company faces **significant competition from larger pharmaceutical and biotechnology companies with greater resources and established therapies**[233](index=233&type=chunk)[234](index=234&type=chunk)[235](index=235&type=chunk)[236](index=236&type=chunk) [Risks related to manufacturing](index=50&type=section&id=Risks%20related%20to%20manufacturing) This section details risks associated with the complex manufacturing processes for gene therapies, including production interruptions and quality control - **Gene therapies are novel, complex, and difficult to manufacture**, posing risks of **production interruptions, equipment malfunctions, facility contamination, raw material shortages, and human error**[256](index=256&type=chunk)[257](index=257&type=chunk) - Even **minor deviations in the manufacturing process could result in product defects, lot failures, product recalls, or insufficient inventory**, **delaying clinical trials or commercial launches**[257](index=257&type=chunk)[258](index=258&type=chunk) [Risks related to our reliance on third parties](index=50&type=section&id=Risks%20related%20to%20our%20reliance%20on%20third%20parties) This section discusses risks arising from the company's dependence on third-party contractors for critical aspects of its operations - AVROBIO **relies on third parties for vector production, product manufacturing, protocol development, research, and preclinical/clinical testing**, which **reduces control and poses risks if these parties do not perform satisfactorily**[259](index=259&type=chunk)[260](index=260&type=chunk)[261](index=261&type=chunk)[262](index=262&type=chunk)[263](index=263&type=chunk) - The company **depends on sole source suppliers** for its **automated, closed cell processing system, vector supply, plasmid supply, cell culture media, and drug product manufacturing**, creating **significant supply chain risks**[264](index=264&type=chunk)[265](index=265&type=chunk)[266](index=266&type=chunk)[268](index=268&type=chunk)[269](index=269&type=chunk) - **Contract manufacturers are subject to extensive cGMP regulations**, and **failure to meet these requirements could lead to delays, regulatory sanctions, or facility closures**[271](index=271&type=chunk)[272](index=272&type=chunk)[273](index=273&type=chunk)[274](index=274&type=chunk) - **Reliance on third parties necessitates sharing trade secrets**, **increasing the risk of competitors discovering them or unauthorized disclosure**, which could **impair the company's competitive position**[275](index=275&type=chunk)[276](index=276&type=chunk)[277](index=277&type=chunk) [Risks related to commercialization of our product candidates](index=53&type=section&id=Risks%20related%20to%20commercialization%20of%20our%20product%20candidates) This section addresses risks concerning market acceptance, reimbursement, and regulatory hurdles for commercializing product candidates - If AVROBIO is **unable to establish its own sales, distribution, and marketing capabilities or enter into agreements with third parties**, it will be **unable to generate product revenue**[278](index=278&type=chunk)[279](index=279&type=chunk) - The **commercial success of any product candidate depends on market acceptance by physicians, patients, and third-party payors**, which is **uncertain for novel gene therapy products**[281](index=281&type=chunk)[282](index=282&type=chunk)[284](index=284&type=chunk) - The **insurance coverage and reimbursement status of newly-approved products are uncertain**, and **failure to obtain or maintain adequate coverage could limit marketability and revenue**[286](index=286&type=chunk)[287](index=287&type=chunk)[288](index=288&type=chunk)[289](index=289&type=chunk)[290](index=290&type=chunk) - **Healthcare legislative reform measures and cost containment initiatives, both domestically and internationally**, could **adversely affect demand, pricing, and profitability of product candidates**[291](index=291&type=chunk)[292](index=292&type=chunk)[294](index=294&type=chunk)[295](index=295&type=chunk)[296](index=296&type=chunk) - **Negative public opinion and increased regulatory scrutiny of gene therapy and genetic research** may **damage public perception of product candidates or adversely affect business operations and regulatory approvals**[302](index=302&type=chunk) [Risks related to our intellectual property](index=64&type=section&id=Risks%20related%20to%20our%20intellectual%20property) This section covers risks related to protecting the company's intellectual property, including patents and license agreements - **Third-party claims of intellectual property infringement may prevent or delay AVROBIO's development and commercialization efforts**, potentially requiring **substantial litigation expense or licensing fees**[331](index=331&type=chunk)[332](index=332&type=chunk)[334](index=334&type=chunk)[335](index=335&type=chunk)[336](index=336&type=chunk) - **Rights to develop and commercialize product candidates are subject to license agreements**, and **termination or disputes over these licenses could significantly harm the ability to commercialize products**[338](index=338&type=chunk)[339](index=339&type=chunk)[341](index=341&type=chunk)[342](index=342&type=chunk) - **Inability to obtain and maintain patent protection, or if the scope is insufficient**, could **allow competitors to develop similar products, adversely affecting commercialization**[343](index=343&type=chunk)[344](index=344&type=chunk)[345](index=345&type=chunk) - **Changes in U.S. patent law, including Supreme Court decisions**, could **diminish the value of patents and impair the ability to protect product candidates**[359](index=359&type=chunk)[360](index=360&type=chunk)[361](index=361&type=chunk)[362](index=362&type=chunk)[363](index=363&type=chunk) - **Failure to obtain patent term extension and data exclusivity for product candidates** could **materially harm the business by allowing competitors to enter the market sooner**[365](index=365&type=chunk) [Risks related to ownership of our common stock](index=71&type=section&id=Risks%20related%20to%20ownership%20of%20our%20common%20stock) This section outlines risks associated with the volatility of the company's stock price and corporate governance matters - The **market price of AVROBIO's common stock is highly volatile** and may be influenced by various factors, potentially **preventing investors from reselling shares at or above purchase price**[371](index=371&type=chunk)[372](index=372&type=chunk) - **Concentration of ownership among existing executive officers, directors, and principal stockholders** may prevent new investors from influencing significant corporate decisions[376](index=376&type=chunk) - As an **'emerging growth company' (EGC)**, AVROBIO's **reduced disclosure requirements** may **make its common stock less attractive to investors, potentially leading to a less active trading market and more volatile stock price**[378](index=378&type=chunk)[379](index=379&type=chunk)[380](index=380&type=chunk) - **Failure to maintain an effective system of internal control over financial reporting** could **lead to inaccurate financial reports, fraud, loss of investor confidence, and a decline in stock price**[384](index=384&type=chunk)[385](index=385&type=chunk)[386](index=386&type=chunk)[387](index=387&type=chunk) - **Provisions in the company's amended and restated certificate of incorporation and by-laws, along with Delaware law**, could **make it more difficult or costly for a third party to acquire the company**[392](index=392&type=chunk)[394](index=394&type=chunk) [General Risk Factors](index=76&type=section&id=General%20Risk%20Factors) This section presents broader risks, including economic conditions, cybersecurity, and changes in tax law, affecting the company - **Unfavorable global economic conditions, such as those caused by the COVID-19 pandemic or geopolitical events like the war in Ukraine**, could **adversely affect AVROBIO's business, financial condition, or results of operations**[397](index=397&type=chunk) - The **company's internal computer systems, or those of its collaborators, are vulnerable to security breaches (e.g., cyberattacks)**, which could **disrupt product development programs and harm business operations**[400](index=400&type=chunk) - **Changes in tax law could adversely affect AVROBIO's business and financial condition, impacting cash flow and results of operations**[401](index=401&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=77&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is marked as "Not applicable," indicating no information to report regarding unregistered sales of equity securities or use of proceeds for the period - Not applicable[402](index=402&type=chunk) [Item 3. Defaults Upon Senior Securities](index=77&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is marked as "Not applicable," indicating no information to report regarding defaults upon senior securities for the period - Not applicable[402](index=402&type=chunk) [Item 4. Mine Safety Disclosures](index=77&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is marked as "Not applicable," indicating no information to report regarding mine safety disclosures for the period - Not applicable[402](index=402&type=chunk) [Item 5. Other Information](index=77&type=section&id=Item%205.%20Other%20Information) This item is marked as "Not applicable," indicating no other information to report for the period - Not applicable[402](index=402&type=chunk) [Item 6. Exhibits](index=78&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Form 10-Q, including corporate documents, certifications, and interactive data files - Exhibits include the Fourth Amended and Restated Certificate of Incorporation, Amended and Restated By-laws, and various certifications (e.g., Section 302, Section 906)[405](index=405&type=chunk) - Interactive Data Files (Inline XBRL) are furnished as part of the report[405](index=405&type=chunk) [Signatures](index=79&type=section&id=Signatures) This section contains the required signatures of the registrant's authorized officers, confirming the submission of the report - The report was signed by Geoff MacKay (President, Chief Executive Officer, and Principal Executive Officer) and Erik Ostrowski (Chief Financial Officer and Principal Financial and Accounting Officer) on May 10, 2022[408](index=408&type=chunk)