AVROBIO Inc

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 31,2023

☐ 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

(Exact name of registrant as specified in its charter)

(617)914-8420

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Securities registered pursuant to Section 12(g) of the Act:

None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes☐ No ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes☐ No ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes☐ No☒

The aggregate market value of the registrant’s common stock held by non-affiliates of the registrant was approximately $36,571,122 as of June 30, 2023 (based on a closing price of $0.95 share as quoted by the Nasdaq Global Select Market as of such date). In determining the market value of non-affiliate common stock, shares of the registrant’s common stock beneficially owned by officers, directors and affiliates have been excluded. This determination of affiliate status is not necessarily a conclusive determination for other purposes.

The registrant had 44,860,515 shares of Common Stock, $0.0001 par value per share, outstanding as of March 7, 2024.

DOCUMENTS INCORPORATED BY REFERENCE

None.

AVROBIO, Inc.

Annual Report on Form 10-K for the Fiscal Year Ended December 31, 2023

Table of Contents

i

Summary Risk Factors

The business of AVROBIO, Inc., or AVROBIO, is subject to numerous risks and uncertainties that you should be aware of in evaluating AVROBIO’s business. These risks include, but are not limited to, the following, including risks related to the proposed merger (as defined below) with Tectonic Therapeutic, Inc., a Delaware corporation, or Tectonic:

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The exchange ratio (as defined below) will not change or otherwise be adjusted based on the market price of AVROBIO common stock as the exchange ratio depends on AVROBIO’s net cash at the closing and not the market price of AVROBIO common stock, so the merger consideration at the closing may have a greater or lesser value than at the time the Merger Agreement (as defined below) was signed.

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Failure to complete the merger may result in either AVROBIO or Tectonic paying a termination fee to the other party, and could harm the AVROBIO common stock price and future business and operations of each company.

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Some AVROBIO and Tectonic directors and executive officers have interests in the merger that are different from AVROBIO stockholders and that may influence them to support or approve the merger without regard to AVROBIO stockholders’ interests.

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AVROBIO stockholders and Tectonic stockholders may not realize a benefit from the merger commensurate with the ownership dilution they will experience in connection with the merger, including the issuance of Tectonic common stock in the private financings (as defined below).

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If the merger is not completed, AVROBIO’s stock price may decline significantly.

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AVROBIO has incurred net losses since inception, expects to incur net losses for the foreseeable future and may never achieve or maintain profitability.

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If AVROBIO decides to resume development of its product candidates, AVROBIO will need additional funding, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force AVROBIO to delay, limit or terminate AVROBIO’s product development efforts or other operations.

•

Business interruptions resulting from the coronavirus disease, or COVID-19, pandemic or similar public health crises have caused and may in the future cause a disruption of the development of AVROBIO’s product candidates and adversely impact AVROBIO’s business.

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AVROBIO’s hematopoietic stem cell, or HSC, lentiviral-based gene therapy product candidates are based on a novel technology, which makes it difficult to predict the time and cost of product candidate development and of subsequently obtaining regulatory approval, should AVROBIO resume development of AVROBIO’s product candidates.

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AVROBIO’s product candidates and the process for administering AVROBIO’s product candidates may cause undesirable side effects or have other properties that, should AVROBIO resume development of its product candidates, could delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences following any potential marketing approval.

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Success in preclinical studies or early clinical trials may not be indicative of results obtained in later trials, should AVROBIO resume development of its product candidates.

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Should AVROBIO resume development of its product candidates, AVROBIO may find it difficult to enroll patients in AVROBIO’s clinical trials, which could delay or prevent AVROBIO from proceeding with clinical trials of AVROBIO’s product candidates.

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Should AVROBIO resume development of its product candidates, AVROBIO may encounter substantial delays in resuming its clinical trials or AVROBIO may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.

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Should AVROBIO resume development of its product candidates, even if AVROBIO completes the necessary preclinical and clinical studies, AVROBIO cannot predict whether or when AVROBIO would be able to obtain regulatory approval to commercialize a product candidate, and any approval could be for a narrower indication than anticipated.

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AVROBIO’s commercially-scalable plato® platform has been used in only two of AVROBIO’s clinical trials and clinical development has been halted.

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AVROBIO faces significant competition in AVROBIO’s industry and, should AVROBIO resume development of its product candidates, there can be no assurance that AVROBIO’s product candidates, if approved, will achieve

ii acceptance in the market over existing established therapies. In addition, AVROBIO’s competitors may develop therapies that are more advanced or effective than AVROBIO’s, which may adversely affect AVROBIO’s ability to successfully market or commercialize any of AVROBIO’s product candidates, should AVROBIO resume development of AVROBIO’s product candidates.

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Gene therapies are novel, complex and difficult to manufacture. Should AVROBIO resume development of its product candidates, AVROBIO could experience production problems that result in delays in AVROBIO’s development or commercialization programs or otherwise adversely affect AVROBIO’s business.

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Should AVROBIO resume development of its product candidates, AVROBIO expects to rely on third parties to conduct some or all aspects of AVROBIO’s vector production, product manufacturing, protocol development, research and preclinical and clinical testing, and these third parties may not perform satisfactorily.

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AVROBIO has historically relied, and, should AVROBIO resume development of its product candidates, expects to continue to rely, on sole source suppliers for AVROBIO’s automated, closed cell processing system; vector supply; plasmid supply; cell culture media supply; and drug product manufacturing. In addition, AVROBIO is dependent on a limited number of suppliers for some of AVROBIO’s other components and materials used in AVROBIO’s product candidates.

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Should AVROBIO resume development of its product candidates, third-party claims of intellectual property infringement may prevent or delay AVROBIO’s development and commercialization efforts.

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AVROBIO’s rights to develop and commercialize its product candidates, should AVROBIO resume development of its product candidates, are subject, in part, to the terms and conditions of licenses granted to AVROBIO by others.

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If AVROBIO experiences material weaknesses or deficiencies in the future, or otherwise fails to establish and maintain effective internal controls, AVROBIO may be unable to produce timely and accurate financial statements, and AVROBIO may conclude that its internal control over financial reporting is not effective, which could adversely impact AVROBIO’s investors’ confidence and AVROBIO’s stock price.

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AVROBIO’s failure to meet Nasdaq Global Select Market’s, or Nasdaq, continued listing requirements could result in a delisting of AVROBIO common stock.

The summary risk factors described above should be read together with the text of the full risk factors below, in the section entitled “Risk Factors” and the other information set forth in this Annual Report on Form 10-K, including AVROBIO’s consolidated financial statements and the related notes, as well as in other documents that AVROBIO files with the Securities and Exchange Commission, or the SEC. The risks summarized above or described in full below are not the only risks that AVROBIO faces. Additional risks and uncertainties not precisely known to AVROBIO, or that AVROBIO currently deems to be immaterial may also materially adversely affect AVROBIO’s business, financial condition, results of operations and future growth prospects.

Forward-looking Information

This Annual Report on Form 10-K contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. These statements may be identified by such forward-looking terminology as “aims,” “anticipates,” “believes,” “continue,” “could,” “designed to,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “predicts,” “projects,” “seeks,” “strives,” “should,” “will,” and similar expressions or the negative of these terms. AVROBIO’s forward-looking statements are based on a series of expectations, assumptions, estimates and projections about AVROBIO, are not guarantees of future results or performance and involve substantial risks and uncertainty. AVROBIO may not actually achieve the plans, intentions or expectations disclosed in AVROBIO’s forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. AVROBIO’s business and its forward-looking statements involve substantial known and unknown risks and uncertainties, including the risks and uncertainties inherent in AVROBIO’s statements regarding:

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the risk that the conditions to closing of the potential merger with Tectonic are not satisfied, including failure to obtain stockholder approval for the transactions;

•

AVROBIO’s ability to meet expectations regarding the timing and completion of the merger;

iii

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uncertainties as to the timing and costs of the consummation of the transactions contemplated by the Merger Agreement and the ability of AVROBIO and Tectonic to consummate the transaction, including the private financings;

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the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the Merger Agreement;

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the fact that under the terms of the Merger Agreement, AVROBIO is restrained from soliciting other acquisition proposals during the pendency of the merger, except in certain circumstances;

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the effect of the announcement or pendency of the merger on AVROBIO’s business relationships, operating results and business generally, including disruption of AVROBIO’s management’s attention from ongoing business operations due to the merger and potential adverse reactions or changes to business relationships resulting from the announcement or completion of the transactions;

•

the risk that the Merger Agreement may be terminated in circumstances that require AVROBIO to pay a termination fee;

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the outcome of any legal proceedings that may be instituted against AVROBIO, Tectonic or any of each company’s respective directors or officers related to the Merger Agreement or the transactions contemplated thereby;

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the impact of the COVID-19 pandemic or any other public health crisis on AVROBIO’s clinical trial programs, should AVROBIO resume development of its product candidates, clinical supply and business generally;

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should AVROBIO resume development of its product candidates, the timing, progress and results of preclinical studies and clinical trials for AVROBIO’s programs and product candidates, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and AVROBIO’s research and development programs;

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should AVROBIO resume development of its product candidates, the existence or absence of side effects or other properties relating to AVROBIO’s product candidates which could delay or prevent their regulatory approval, limit their commercial potential, or result in significant negative consequences following any potential marketing approval;

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the durability of effects from AVROBIO’s product candidates, should AVROBIO resume development of its product candidates;

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the timing, scope or likelihood of regulatory filings and approvals, should AVROBIO resume development of its product candidates;

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should AVROBIO resume development of its product candidates, the anticipated regulatory pathway for its product candidates and planned interactions with regulatory agencies;

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should AVROBIO resume development of its product candidates, AVROBIO’s ability to develop and advance product candidates into, and successfully complete, clinical studies;

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should AVROBIO resume development of its product candidates, AVROBIO’s expectations regarding the size of the patient populations for its product candidates, if approved for commercial use;

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the implementation of AVROBIO’s business model and its strategic plans for its business, product candidates, should AVROBIO resume development of its product candidates, technology and plato platform;

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should AVROBIO resume development of its product candidates, AVROBIO’s commercialization, marketing and manufacturing capabilities and strategy;

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should AVROBIO resume development of its product candidates, the pricing and reimbursement of AVROBIO’s product candidates, if approved;

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should AVROBIO resume development of its product candidates, the scalability and commercial viability of AVROBIO’s manufacturing methods and processes, including AVROBIO’s move to a closed, automated system;

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should AVROBIO resume development of its product candidates, the rate and degree of market acceptance and clinical utility of its product candidates, in particular, and gene therapy, in general;

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AVROBIO’s ability to establish or maintain collaborations or strategic relationships or obtain additional funding;

iv

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AVROBIO’s competitive position;

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the scope of protection AVROBIO and/or its licensors are able to establish and maintain for intellectual property rights covering its product candidates, should AVROBIO resume development of its product candidates, as well as any statements as to whether AVROBIO does or does not infringe, misappropriate or otherwise violate any third-party intellectual property rights;

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AVROBIO’s financial performance;

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AVROBIO’s ability to retain the continued service of its key professionals and, should AVROBIO resume development of its product candidates, to identify, hire and retain additional qualified professionals;

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should AVROBIO resume development of its product candidates, developments and projections relating to its competitors and industry, including other lentiviral or HSC gene therapy companies;

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AVROBIO’s expectations related to the use of its cash reserves;

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AVROBIO’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

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AVROBIO’s ability to avoid any findings of material weaknesses or significant deficiencies in the future;

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AVROBIO’s ability to satisfy the continued listing requirements of the Nasdaq, including a minimum bid price, and to maintain its common stock listing on Nasdaq or any stock exchange;

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the impact of laws and regulations, including without limitation recently enacted tax reform legislation; and

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other risks and uncertainties, including those listed under the caption “Risk Factors.”

All of AVROBIO’s forward-looking statements are as of the date of this Annual Report on Form 10-K only. In each case, actual results may differ materially from such forward-looking information. AVROBIO can give no assurance that such expectations or forward-looking statements will prove to be correct. An occurrence of or any material adverse change in one or more of the risk factors or risks and uncertainties referred to in this Annual Report on Form 10-K or included in AVROBIO’s other public disclosures or its other periodic reports or other documents or filings filed with or furnished to the SEC could materially and adversely affect AVROBIO’s business, prospects, financial condition and results of operations. Except as required by law, AVROBIO does not undertake or plan to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections or other circumstances affecting such forward-looking statements occurring after the date of this Annual Report on Form 10-K, even if such results, changes or circumstances make it clear that any forward-looking information will not be realized. Any public statements or disclosures by AVROBIO following this Annual Report on Form 10-K that modify or impact any of the forward-looking statements contained in this Annual Report on Form 10-K will be deemed to modify or supersede such statements in this Annual Report on Form 10-K.

Note Regarding Trademarks

All brand names or trademarks appearing in this report are the property of their respective holders.

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