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1. Moderna, but for engineered bacteria.

2. An early-stage Amgen, specializing in live bacterial therapies.

3. CRISPR Therapeutics, but developing 'living medicines' from gut bacteria.

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• SYNB1934: An orally administered synthetic biotic medicine currently in development to treat hyperuricemia in patients with gout.

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Synlogic (SYBX) is a clinical-stage biotechnology company focused on the research and development of a novel class of synthetic biotics for the treatment of rare metabolic and inflammatory diseases. As a company in the discovery and clinical development phase, Synlogic does not currently have "major customers" in the traditional sense of selling approved commercial products to either companies or individuals.

Companies at this stage primarily generate capital through equity financing, strategic collaborations, and grants, rather than product sales. If one were to consider entities that have provided significant funding or entered into strategic alliances (which are the closest equivalent to "customers" for a company at this stage of development), these would typically be larger pharmaceutical companies or government/non-profit organizations.

Historically, Synlogic has engaged in collaboration agreements that provided revenue. While specific major revenue-generating collaborations for their current pipeline are not active in a commercial product sales context, a notable past partner that fits the description of a company in a collaboration context was:

• Roche (Genentech): Synlogic had a research collaboration with Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY). This collaboration focused on inflammatory bowel disease and contributed to Synlogic's revenue during its active period, though it was terminated in 2021.

Currently, following a reverse merger, Synlogic's focus is on advancing its pipeline of investigational therapies for rare diseases, and it is not engaged in commercial product sales to other companies or individuals.

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Aoife Brennan, M.B., B.Ch. President and Chief Executive Officer

Dr. Aoife Brennan joined Synlogic as Chief Medical Officer in 2016 and was appointed President and Chief Executive Officer in October 2018. Before joining Synlogic, she spent six years at Biogen, most recently as Vice President and Head of the Rare Disease Innovation Unit, where she was involved in programs ranging from pre-clinical to commercial. She also led clinical development at Tolerx, a startup biotechnology company focused on immunotherapy for Type 1 diabetes. Dr. Brennan holds a medical degree from Trinity College Dublin, Ireland, and completed post-graduate training in internal medicine, endocrinology, and metabolism. She has also served as a director and advisor to several public and private biotech companies, including Ra Pharmaceuticals, Inc., which was acquired by UCB.

Michael Jensen Chief Financial Officer

Michael Jensen was appointed Chief Financial Officer of Synlogic in March 2022. Prior to Synlogic, Mr. Jensen served as the CFO at Intrinsic Therapeutics, a commercial-stage medical device company. His career includes financial leadership roles at various biotech and healthcare companies such as Taconic Biosciences, Straumann North America, Siemens Healthcare Diagnostics, Novartis, and Novo Nordisk Inc. Mr. Jensen holds a Master of Economics and Business Administration degree from Copenhagen Business School in Denmark.

David L. Hava, Ph.D. Head of Research and Development

David L. Hava is the Head of Research and Development at Synlogic. He also holds the title of Chief Scientific Officer. Synlogic announced his appointment as Head of Research and Development in January.

Antoine Awad Chief Operating Officer

Antoine "Tony" Awad serves as the Chief Operating Officer at Synlogic, Inc.

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The key risks to Synlogic's (SYBX) business are as follows:

1. Risk of Nasdaq Delisting and "Public Shell" Status: Synlogic recently received a notice from the Nasdaq Stock Market's Listing Qualifications Department, expressing concerns that the company is a "public shell" due to its lack of revenue-generating assets and significantly reduced operations since February 2024. This could lead to the delisting of its securities, although Synlogic plans to contest this decision. The absence of revenue in 2025 and minimal research and development expenses were highlighted as contributing factors to this assessment.
2. Financial Instability, Persistent Losses, and Negative Cash Flows: The company faces ongoing financial challenges, including persistent losses and negative cash flows. An AI analyst report also noted low stock scores driven primarily by these financial issues and negative valuation metrics, reflecting a struggle with profitability and a lack of positive earnings or dividends. The company's decision in February 2024 to discontinue Synpheny-3, its pivotal study of labafenogene marselecobac (SYNB1934) in phenylketonuria (PKU), and to evaluate strategic options has further impacted its financial position, leading to restructuring charges and a significant reduction in R&D expenses.
3. Uncertainties Inherent in Clinical Development and Regulatory Approval: As a clinical-stage biotechnology company, Synlogic's success heavily relies on the uncertain clinical and preclinical development process of its product candidates. The ability to obtain regulatory approval for its product candidates is a significant risk, and there is no assurance that its development efforts will lead to commercialized products.

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The clear emerging threat to Synlogic (SYBX) is the advancement and potential success of gene therapies for monogenic metabolic disorders, particularly Phenylketonuria (PKU).

Synlogic's lead product candidate, SYNB1934, is an engineered living bacterial therapeutic designed for the chronic management of PKU. Gene therapies, such as the investigational gene therapy by PTC Therapeutics for PKU, represent a fundamentally different and potentially curative approach. If gene therapies prove highly effective, safe, and durable, they could offer a one-time treatment for these disorders, significantly altering the standard of care and reducing the long-term market opportunity for chronic management therapies like Synlogic's. This potential shift from chronic treatment to a cure, driven by a rapidly advancing and distinct technological modality, represents a clear emerging threat to the market position of Synlogic's product candidates for monogenic disorders.

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Expected Drivers of Future Revenue Growth for Synlogic (SYBX)

Over the next 2-3 years, Synlogic's future revenue growth is expected to be driven by the following key factors:

1. Clinical Development and Potential Commercialization of SYNB1353 for Homocystinuria (HCU): Synlogic's SYNB1353 program, aimed at treating homocystinuria, is a significant potential revenue driver. The candidate has received Fast Track and Rare Pediatric Disease Designations from the FDA, has demonstrated proof of mechanism in a Phase 1 study, and is advancing into a Phase 2 study. Successful progression through clinical trials and eventual market approval would position SYNB1353 as a primary source of product-based revenue.
2. Clinical Development and Potential Commercialization of SYNB8802 for Enteric Hyperoxaluria: Another key pipeline asset, SYNB8802, is currently in Phase 2 clinical trials for the treatment of enteric hyperoxaluria and has demonstrated proof of concept in a Phase 1b study. The successful advancement and potential commercialization of SYNB8802 represent an additional opportunity for future product revenue.
3. Expansion of and New Strategic Collaborations and Partnerships: Synlogic has an existing research collaboration with Roche for a novel Synthetic Biotic aimed at inflammatory bowel disease, which has generated milestone payments. Further expanding existing partnerships or forging new strategic collaborations for its Synthetic Biotic platform or other preclinical and clinical assets could provide significant non-product revenue through upfront payments, research and development funding, and potential future milestone payments and royalties.

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Share Repurchases

• In November 2022, Synlogic repurchased 4,196,889 shares of common stock from a stockholder for an aggregate purchase price of $2.5 million, at $0.60 per share, as part of a privately negotiated transaction.

Share Issuance

• In September 2021, Synlogic completed an underwritten public offering of 15,000,000 shares of its common stock at a price of $3.00 per share, generating gross proceeds of $45.0 million.
• In April 2021, the company announced the pricing of an underwritten public offering of 10,000,000 shares of common stock at $3.00 per share, with expected gross proceeds of $30.0 million.
• In October 2023, Synlogic closed an underwritten public offering of 7,394,363 shares of common stock (or pre-funded warrants) and accompanying common warrants, resulting in approximately $21.0 million in aggregate gross proceeds.
• A 1-for-15 reverse stock split was effected on September 28, 2023.

Inbound Investments

• During 2021, Synlogic received an upfront, nonrefundable technology access fee and the first milestone payment related to a collaboration agreement.
• A second milestone payment under the collaboration agreement was received in 2022.
• Synlogic reported receiving a $2.5 million milestone payment from Roche, which, as of Q3 2023, was anticipated to extend the company's cash runway into the first half of 2025.

Capital Expenditures

• Capital expenditures were $728,000 in 2022.
• Capital expenditures decreased to $214,000 in 2023.
• Capital expenditures were $14,000 in 2024, representing a significant decrease from the prior year.