Financial Performance - The company has incurred a net loss of $6.8 million for the three months ended March 31, 2024, compared to a net loss of $25.0 million for the same period in 2023, resulting in an accumulated deficit of $484.1 million as of March 31, 2024[112]. - Net loss for the three months ended March 31, 2024, was $6.8 million, compared to a net loss of $25.0 million for the same period in 2023, an improvement of $18.2 million[129]. - Interest income increased to $1.1 million for the three months ended March 31, 2024, from $0.3 million for the same period in 2023, an increase of $0.8 million[132]. - Cash and cash equivalents as of March 31, 2024, were $90.5 million[140]. - Net cash used in operating activities was $7.6 million for the three months ended March 31, 2024, compared to $20.3 million for the same period in 2023[143]. Research and Development - Research and development expenses totaled $683,000 for the three months ended March 31, 2024, significantly down from $17.3 million for the same period in 2023[120]. - Research and development expenses decreased by approximately $16.7 million to $0.7 million for the three months ended March 31, 2024, from $17.3 million for the same period in 2023[130]. - The company has terminated all treatment-related and long-term follow-up clinical studies for its Gaucher disease and Fabry disease programs, and discontinued its Hunter syndrome gene therapy program[107]. - The company expects substantial increases in expenses if product development resumes, particularly for preclinical activities and clinical trials[146]. - The establishment of a sales, marketing, and distribution infrastructure is necessary for the commercialization of product candidates[147]. Strategic Plans and Mergers - The company plans to halt development of its gene therapy programs and explore strategic alternatives, including potential mergers or acquisitions[106]. - A merger agreement has been entered into with Tectonic, with certain investors agreeing to purchase shares at a price of $12.39908 per share, totaling approximately $130.7 million in private financings[108]. - The merger is subject to approval by stockholders and is conditioned upon receiving cash proceeds of not less than $114.5 million[109]. - Future operations are highly dependent on the success of the merger, with no assurances that it will be consummated[110]. Funding and Expenses - The company has received gross cash proceeds of $428.1 million from sales of common stock through its IPO and follow-on offerings, and $87.5 million from the sale of its cystinosis gene therapy program[111]. - The company has not generated any product revenue since its inception in 2015 and relies on external funding to support operations[111]. - The company anticipates an increase in general and administrative expenses as it resumes development of product candidates and increases headcount[125]. - General and administrative expenses were $7.3 million for the three months ended March 31, 2024, compared to $7.9 million for the same period in 2023, a decrease of $0.6 million[131]. - Total operating expenses decreased by $17.3 million to $7.9 million for the three months ended March 31, 2024, from $25.2 million for the same period in 2023[129]. Currency and Financial Risk - The company recognized foreign currency transaction losses of $13, and $28 for the three months ended March 31, 2024, and 2023, respectively[154]. - A 10% change in the exchange rate between the U.S. dollar and other currencies is not expected to materially impact the financial position or results of operations[154]. - The company may finance cash needs through equity offerings, debt financings, and collaboration agreements, which could involve relinquishing valuable rights[148]. - The company has not entered into any foreign currency hedging contracts to mitigate exposure to foreign currency exchange risk[155]. Operational Considerations - Additional personnel will need to be hired and retained to support clinical, medical, and commercial operations[147]. - The company may need to delay or limit product development if additional funds are not raised when needed[148]. - There were no material changes to the company's critical accounting policies during the three months ended March 31, 2024[150].

Merger and Ownership Structure - AVROBIO securityholders are expected to own approximately 22.3% of the combined company, while former Tectonic securityholders are expected to own approximately 39.8%[61]. - The merger agreement includes an exchange ratio based on AVROBIO's net cash at closing, anticipated to be between $65.0 million and $75.0 million[61]. - If AVROBIO's net cash is below $65.0 million, the exchange ratio will be adjusted, resulting in a smaller ownership percentage for AVROBIO stockholders[61]. - The merger cannot be consummated without the approval of certain proposals by AVROBIO stockholders[63]. - Following the merger, AVROBIO stockholders are expected to own approximately 22.3% of the combined company, while former Tectonic stockholders are expected to own approximately 39.8%[67]. - AVROBIO anticipates its net cash at closing will be between $65.0 million and $75.0 million, with ownership percentages based on an assumption of $65.0 million[67]. - If the merger is not completed, AVROBIO may be required to pay Tectonic a termination fee of $2,712,500, or Tectonic may owe AVROBIO $4,900,000[67]. - The completion of the merger is subject to various conditions, including approval from both AVROBIO and Tectonic stockholders[75]. Financial Performance and Capital Requirements - AVROBIO incurred a net loss of $105.9 million for the year ended December 31, 2022, and a net income (loss) of $12.2 million for the year ended December 31, 2023[78]. - AVROBIO has received a cash payment of $87.5 million from Novartis for the sale of its cystinosis gene therapy program, which has allowed the company to pay off all outstanding amounts under its Term Loan Agreement[78]. - The combined company may need to raise additional capital, potentially causing significant dilution to existing shareholders[64]. - AVROBIO's future capital requirements will depend on various factors, including the costs associated with drug discovery, clinical trials, and potential regulatory reviews[82]. - The company may need additional funding to resume development of its product candidates, which may not be available on acceptable terms[82]. - AVROBIO's exploration of strategic alternatives may involve entering into acquisitions or mergers, which could result in dilution for existing stockholders[83]. Strategic Alternatives and Operational Focus - In July 2023, AVROBIO announced a comprehensive exploration of strategic alternatives to maximize stockholder value, including a proposed merger with Tectonic announced in January 2024[79]. - AVROBIO's management and employees are currently focused on the merger, which may divert attention from day-to-day operations[74]. - The company has halted further development of its programs and conducted reductions in force while evaluating strategic alternatives[82]. - AVROBIO's cash conservation activities may lead to unintended consequences, including employee attrition and reduced morale[78]. - The company has implemented workforce reductions to conserve capital expenditures, but may not realize the anticipated savings or operational efficiencies from these restructuring efforts[87]. Clinical Development and Regulatory Challenges - AVROBIO's clinical development has been halted, and the commercially-scalable plato platform has been used in only two clinical trials[96]. - The company has limited experience in preparing and submitting regulatory filings, having never completed a pivotal or registrational clinical trial[92]. - The regulatory approval process for AVROBIO's novel product candidates may be more expensive and time-consuming compared to other therapies, with limited prior approvals in the HSC gene therapy space[90]. - AVROBIO's ability to conduct clinical trials may be impacted by changes in hospital policies, government regulations, and disruptions in third-party services[89]. - The company may face significant delays in resuming clinical trials due to challenges in patient enrollment, particularly for rare diseases[94]. Intellectual Property and Competitive Landscape - AVROBIO's ability to compete effectively depends on maintaining proprietary technology and manufacturing processes[129]. - The company may face substantial litigation expenses and resource diversion if claims of patent infringement arise[128]. - AVROBIO's reliance on trade secrets and confidentiality agreements poses risks, as these can be difficult to enforce[129]. - Changes in U.S. patent law, particularly the Leahy-Smith America Invents Act, could increase uncertainties and costs related to patent applications and enforcement, potentially adversely affecting AVROBIO's business[130]. - AVROBIO's ability to protect its intellectual property may be compromised if it cannot secure patent term extensions or data exclusivity for its product candidates, which could lead to reduced revenue[132]. Market and Economic Conditions - The market price of AVROBIO common stock is subject to significant fluctuations, particularly in the context of the merger's completion[66]. - AVROBIO's stock price may decline if the market assumes the merger will not be completed[73]. - The company is subject to provisions in its charter and bylaws that could delay or prevent a change in control, including the authorization of "blank check" preferred stock and a classified board of directors[138]. - AVROBIO's financial condition could be adversely affected by unfavorable global economic conditions, including the impacts of the COVID-19 pandemic and geopolitical events[141]. - The company has faced cybersecurity threats in the past, including a cyberattack in 2017 that led to the theft of funds, which could disrupt operations if similar incidents occur in the future[141]. Compliance and Regulatory Risks - AVROBIO is subject to various U.S. and foreign healthcare laws, and non-compliance could result in substantial penalties and reputational harm[120]. - Compliance with data protection laws, including GDPR, is critical, as violations could result in fines up to 4% of global revenues or €20 million[122]. - The company may need to enhance its business processes and systems to support future growth and ensure compliance with regulatory requirements[120]. - AVROBIO's suppliers have not undergone FDA approval processes, which poses risks for the company's ability to meet regulatory requirements[109]. Employee and Management Issues - AVROBIO has implemented workforce reductions, including a 50% reduction in July 2023 and further cuts in October, November, and December 2023, impacting employee morale and retention[118]. - The company is currently led by an interim CEO following the resignation of the former President and CEO on May 1, 2023, with no timeline for hiring a permanent replacement[118]. - AVROBIO's ability to retain key personnel is critical for its future success, with a competitive landscape for skilled employees in the biotechnology sector[118].

Merger Details - AVROBIO and Tectonic Therapeutic have entered into a definitive merger agreement in an all-stock transaction, with AVROBIO acquiring 100% of Tectonic's equity [1] - The combined company will operate under the name Tectonic Therapeutic, Inc and trade on Nasdaq under the ticker symbol "TECX" [1] - Tectonic has raised $130.7 million in a private placement, with the combined company expected to have approximately $165 million in cash and cash equivalents at closing [1] Strategic Rationale - The merger enhances Tectonic's ability to advance its clinical-stage Fc-relaxin fusion protein, TX45, and other pipeline assets [2] - Tectonic's GEODeTM platform enables the discovery of biologics targeting challenging GPCRs, which are central to human biology and the target of over 30% of approved drugs [2][3] - The combined company is expected to have sufficient cash to fund operations into mid-2027 [1] Tectonic's Pipeline - TX45, a potential best-in-class Fc-relaxin fusion protein, is being developed for Group 2 Pulmonary Hypertension in HFpEF patients, affecting over 600,000 people in the US [4] - Phase 1a data for TX45 has shown promising PK/PD effects, with Phase 1b and Phase 2 data expected in 2025 and 2026, respectively [5] - Tectonic's second program targets Hereditary Hemorrhagic Telangiectasia (HHT), affecting approximately 75,000 patients in the US, with human studies planned for late 2025 to early 2026 [5] - A third program focuses on fibrosis using a bispecific approach to inhibit two different receptors [5] Financial and Organizational Structure - Post-merger, AVROBIO shareholders will own approximately 22.3% of the combined company, while Tectonic shareholders will own approximately 40.2% [6] - The combined company will be led by Tectonic's management team, with one AVROBIO board member joining the new board [7] - The merger is expected to close in Q2 2024, subject to shareholder approvals and other customary closing conditions [7] Advisors - Leerink Partners is serving as exclusive financial advisor to Tectonic, with Cooley LLP as legal counsel [8] - Piper Sandler is acting as capital markets advisor to Tectonic, while TD Cowen and Houlihan Lokey are serving as financial advisors to AVROBIO [8]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Common Stock, $0.0001 par value per share AVRO Nasdaq Global Select Market FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38537 | --- | --- | |----------------------------- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38537 AVROBIO, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 81-0710585 (State or other jurisdiction of (I. ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38537 AVROBIO, INC. (Exact Name of Registrant as Specified in its Charter) Registrant's telephone number, including area code: (6 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-38537 | --- | --- | --- | --- | |-----------------|-------------------------|----------|----------------------------------------| | clas ...

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 ...