Synlogic, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Synlogic, Inc. has filed its 2023 annual report (10-K) detailing financial data and corporate information.</b>

AI Summary

SYNLOGIC, INC. (SYBX) filed a Annual Report (10-K) with the SEC on March 19, 2024. Synlogic, Inc. filed its 2023 Form 10-K on March 19, 2024, reporting on its fiscal year ending December 31, 2023. The filing details various financial instruments and equity components, including common stock, warrants, and restricted stock. Key dates mentioned include the fiscal year end of December 31, 2023, and subsequent events up to February 29, 2024. The company's business address is 301 Binney Street, Suite 402, Cambridge, MA 02142. Synlogic, Inc. was formerly known as Mirna Therapeutics, Inc., with a name change effective August 9, 2011.

Why It Matters

For investors and stakeholders tracking SYNLOGIC, INC., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Synlogic's financial position and operational activities for the fiscal year 2023, crucial for investors and stakeholders to assess performance and future outlook. The detailed breakdown of financial instruments and equity components offers insights into the company's capital structure and potential dilution factors.

Risk Assessment

Risk Level: medium — SYNLOGIC, INC. shows moderate risk based on this filing. The company's financial health and operational status are detailed in this 10-K, but specific financial performance metrics like revenue and net income are not provided in the extracted text, necessitating further review of the full filing.

Analyst Insight

Review the full 10-K filing for detailed financial statements, including revenue, net income, and cash flow, to fully assess Synlogic's financial performance and strategic direction.

Key Numbers

• 2023-12-31 — Fiscal Year End (CONFORMED PERIOD OF REPORT)
• 2024-03-19 — Filing Date (FILED AS OF DATE)
• 2024-02-01 to 2024-02-29 — Subsequent Event Period (us-gaap:SubsequentEventMember)
• 2023-10-03 — October 2023 Financing Date (srt:MaximumMember sybx:October2023FinancingMember)
• 2023-11-09 — November 2023 Event Date (2023-11-09)
• 2019-06-30 — June 2019 Date (srt:MaximumMember sybx:GinkgoBioworksIncMember sybx:PreFundedWarrantsMember)
• 2023-06-30 — June 2023 Date (2023-06-30)
• 2023-09-27 — September 2023 Date (2023-09-27)

Key Players & Entities

• SYNLOGIC, INC. (company) — COMPANY CONFORMED NAME
• SYBX (company) — Ticker Symbol
• 10-K (document) — FORM TYPE
• 20231231 (date) — CONFORMED PERIOD OF REPORT
• 20240319 (date) — FILED AS OF DATE
• Mirna Therapeutics, Inc. (company) — FORMER COMPANY
• 20110809 (date) — DATE OF NAME CHANGE
• 301 BINNEY STREET SUITE 402 (address) — BUSINESS ADDRESS

FAQ

Key Dates

• 2023-12-31: Fiscal Year End — Reporting period for the 10-K.
• 2024-03-19: Filing Date — Date the 10-K was officially submitted to the SEC.
• 2024-02-01: Subsequent Event Period Start — Marks the beginning of the period for subsequent events disclosed.

Key Financial Figures

• $0.001 — ch registered Common Stock, par value $0.001 per share SYBX The Nasdaq Capital M
• $6.45 — computed based on the closing price of $6.45 per share on June 30, 2023. As of Mar
• $500 million — cts, Kuvan and Palynziq, have generated $500 million and $300 million respectively, in annua
• $300 million — lynziq, have generated $500 million and $300 million respectively, in annual revenue as bran
• $3 billion — opportunity we estimate to be more than $3 billion. For HCU, with an estimated 5,000 patie
• $1 billion — tial market opportunity to be more than $1 billion. Further, these two disease states pr

Filing Documents

• sybx-20231231.htm (10-K) — 2988KB
• sybx-ex10_6.htm (EX-10.6) — 262KB
• sybx-ex10_7.htm (EX-10.7) — 105KB
• sybx-ex10_16.htm (EX-10.16) — 66KB
• sybx-ex10_18.htm (EX-10.18) — 56KB
• sybx-ex10_22.htm (EX-10.22) — 58KB
• sybx-ex10_23.htm (EX-10.23) — 14KB
• sybx-ex10_24.htm (EX-10.24) — 51KB
• sybx-ex10_25.htm (EX-10.25) — 14KB
• sybx-ex10_40.htm (EX-10.40) — 29KB
• sybx-ex21_1.htm (EX-21.1) — 4KB
• sybx-ex23_1.htm (EX-23.1) — 4KB
• sybx-ex31_1.htm (EX-31.1) — 12KB
• sybx-ex31_2.htm (EX-31.2) — 12KB
• sybx-ex32_1.htm (EX-32.1) — 9KB
• sybx-ex32_2.htm (EX-32.2) — 9KB
• img23650160_0.jpg (GRAPHIC) — 5KB
• img24573681_0.jpg (GRAPHIC) — 15KB
• img25497202_0.jpg (GRAPHIC) — 5KB
• img78137899_0.jpg (GRAPHIC) — 9KB
• img78137899_1.jpg (GRAPHIC) — 14KB
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• img120714031_0.jpg (GRAPHIC) — 69KB
• img120714031_1.jpg (GRAPHIC) — 22KB
• img120714031_2.jpg (GRAPHIC) — 39KB
• img120714031_3.jpg (GRAPHIC) — 89KB
• img120714031_4.jpg (GRAPHIC) — 33KB
• img120714031_5.jpg (GRAPHIC) — 145KB
• img120714031_6.jpg (GRAPHIC) — 157KB
• img120714031_7.jpg (GRAPHIC) — 70KB
• img268074070_0.jpg (GRAPHIC) — 5KB
• 0000950170-24-033146.txt (&nbsp;) — 13127KB
• sybx-20231231.xsd (EX-101.SCH) — 1418KB
• sybx-20231231_htm.xml (XML) — 1699KB

Business

Business 2 Item 1A.

Risk Factors

Risk Factors 37 Item 1B. Unresolved Staff Comments 75 Item 1C. Cybersecurity 75 Item 2.

Properties

Properties 76 Item 3.

Legal Proceedings

Legal Proceedings 76 Item 4. Mine Safety Disclosures 77 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 78 Item 6. [Reserved] 78 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 79 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 90 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 90 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 90 Item 9A.

Controls and Procedures

Controls and Procedures 90 Item 9B. Other Information 91 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 91 PART III Item 10. Directors, Executive Officers and Corporate Governance 92 Item 11.

Executive Compensation

Executive Compensation 92 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 92 Item 13. Certain Relationships and Related Transactions, and Director Independence 92 Item 14. Principal Accounting Fees and Services 92 PART IV Item 15. Exhibits, Financial Statement Schedules 93 Item 16. Form 10-K Summary 97 ii

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements that involve risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained herein are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "continue" or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about: our evaluation of strategic alternatives with a goal to enhance stockholder value, including the possibility of a merger or a sale of the Company; the success of our research and development efforts; the initiation, progress, timing, costs and results of clinical trials for our product candidates; the time and costs involved in obtaining regulatory approvals for our product candidates; the success of our collaborations with third parties; the progress, timing and costs involved in developing manufacturing processes and in manufacturing products, as well as agreements with third-party manufacturers; the rate of progress and cost of our commercialization activities; the expenses we incur in marketing and selling our product candidates, if approved; the revenue generated by sales of our product candidates, if approved; the emergence of competing or complementary technological developments; the terms and timing of any additional collaborative, licensing or other arrangements that we may establish; the acquisition of businesses, products and technologies; our need to implement additional infrastructure and internal systems; our need to add personnel and financial and management informa

Bu siness

Item 1. Bu siness. Overview We are a biopharmaceutical company advancing novel therapeutics to transform the care of serious diseases. We focus on rare metabolic disorders, with our lead program, labafenogene marselecobac (SYNB1934), studied in Synpheny-3, a global, pivotal Phase 3 study for patients with phenylketonuria (PKU), and SYNB1353, a potential treatment for homocystinuria (HCU). Both PKU and HCU are caused by inborn errors of metabolism, and present significant need for innovation due to limitations of both efficacy and safety in the currently available medical treatment options. In February 2024, we made the decision to discontinue Synpheny-3, our pivotal study of our lead product candidate, labafenogene marselecobac (SYNB1934), as a potential treatment for PKU. The decision to end Synpheny-3 is based on results of an internal review in advance of an upcoming independent Data Monitoring Committee (DMC) assessment, which indicated the trial was unlikely to meet its primary endpoint. The decision was not based on concerns regarding safety or tolerability. We will now work with the Synpheny-3 clinical trial sites involved to implement the discontinuation. As a result, our current corporate strategy is focused on pursuing strategic initiatives to enhance stockholder value, including but not limited to, a merger or the sale of the Company. Our strategic process is both active and ongoing and includes a range of interactions with transaction counterparties. Thus, we believe it is in our stockholders' best interest to allow sufficient opportunity to pursue and consummate one or more such transactions and to consider additional alternatives that may materialize in the future. However, there can be no assurance that such activities will result in any agreements or transactions that will enhance shareholder value. Further, any strategic transaction that is completed ultimately may not deliver the anticipated benefits or enhance shareholder value. Our early-

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View this 10-K filing on SEC EDGAR