NASDAQ false 0001527599 0001527599 2022-05-12 2022-05-12












Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 12, 2022




(Exact name of registrant as specified in its charter)




Delaware   001-37566   26-1824804

(State or other jurisdiction

of incorporation)



File Number)


(IRS Employer

Identification No.)


301 Binney St., Suite 402

Cambridge, MA

(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (617) 401-9975

Not applicable

(Former Name or Former Address, if Changed Since Last Report)



Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):


Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)


Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))


Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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


Title of each class





Name of each exchange

on which registered

Common Stock   SYBX   The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging Growth Company

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. ☐




Item 2.02

Results of Operations and Financial Condition

On May 12, 2022, Synlogic, Inc. (the “Company”) announced its financial results for the quarter ended March 31, 2022. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.


Item 9.01

Financial Statements and Exhibits.

(d) Exhibits


99.1    Press Release dated May 12, 2022.
104    Cover Page Interactive Data File (embedded within the Inline XBRL document)


Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


Date: May 12, 2022     Synlogic, Inc.

/s/ Gregg Beloff

    Name:   Gregg Beloff
    Title:   Interim Chief Financial Officer

Exhibit 99.1



Synlogic Reports First Quarter 2022 Financial Results and Provides Business Update

- Clinical readouts anticipated for phenylketonuria (PKU), homocystinuria (HCU) and enteric hyperoxaluria programs in H2 2022 –

- PKU program progressing with Phase 3 readiness activities underway –

- $120.5 million in cash, cash equivalents and short-term investments support projected runway into 2024 –

- Conference call and webcast at 8:30 a.m. ET today –

Cambridge, Mass. May 12, 2022 – Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, today reported financial results for the first quarter ended March 31, 2022 and provided an update on pipeline programs.

“We are pleased to share this progress as we seek to advance our novel phenylketonuria (PKU) program towards Phase 3 initiation,” said Synlogic President and Chief Executive Officer Aoife Brennan, M.B. Ch.B. “We believe that we have a unique opportunity to advance a potential treatment for the 55,000 people around the globe with PKU, of whom more than 75% remain in need of additional treatment options – either monotherapy or adjunctive. We are pleased with the progress across our additional programs with expected milestones in 2022, including our homocystinuria (HCU) and enteric hyperoxaluria programs, as well as research progress including our ongoing collaborations with Ginkgo Bioworks and Roche.”

Anticipated Upcoming Milestones



Report additional Phase 2 data and final candidate selection for PKU program in H2 2022



Initiate the Phase 3 trial for the PKU program in H1 2023 with Phase 3 readiness activities currently underway



Share data from the Phase 1 trial in healthy volunteers for SYNB1353 in H2 2022



Share proof of concept data for SYNB8802 for enteric hyperoxaluria in H2 2022


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Recent Business Highlights



Michael Jensen joined Synlogic as CFO in March 2022



Participation and data presentations at scientific congresses described below:



PKU and HCU program data were presented at inborn errors of metabolism congresses including the Society for Inherited Metabolic Disorders (SIMD) Annual Meeting, the Genetic Metabolic Dietitians International (GMDI) 2022 Conference, and the Garrod Symposium 2022



From Synlogic’s Research team, five different programs were represented at the 2022 Synthetic Biology: Engineering, Evolution & Design (SEED) Conference covering preclinical and clinical work in PKU, HCU, enteric hyperoxaluria, inflammatory bowel disease (IBD), and gout



From Process Development & Manufacturing Sciences (PDMS) at Synlogic, a presentation at the 2022 18th Annual Protein Engineering & Cell Therapy Summit (PEGS) Boston Conference & Expo

First Quarter 2022 Financial Results

As of March 31, 2022, Synlogic had cash, cash equivalents and short-term investments of $120.5 million.

Revenue was $0.2 million for the three months ended March 31, 2022. Revenue in 2022 was associated with the ongoing research collaboration with Roche for the discovery of a novel Synthetic Biotic for the treatment of IBD. There was no revenue for the three months ended March 31, 2021.

For the three months ended March 31, 2022, Synlogic reported a consolidated net loss of $15.7 million, or $0.22 per share, compared to a consolidated net loss of $15.0 million, or $0.36 per share, for the corresponding period in 2021.

Research and development expenses were $11.7 million for the three months ended March 31, 2022 compared to $11.2 million for the corresponding period in 2021.

General and administrative expenses were $4.3 million for the three months ended March 31, 2022 compared to $3.9 million for the corresponding period in 2021.


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Financial Outlook

Based upon its current operating plan and balance sheet as of March 31, 2022, Synlogic expects to have sufficient cash to be able to fund operations into 2024.

Investor & Industry Conference Participation

Synlogic will participate in the following upcoming investor and industry conferences:



RBC Capital Markets Global Healthcare Conference. Dr. Brennan will provide a Company presentation on Wednesday, May 18, 2022 at 8:30 am ET during the RBC Capital Markets Global Healthcare Conference to be held in New York City from May 17-18, 2022.



The H.C. Wainwright Global Investment Conference. Chief Financial Officer Michael Jensen and Chief Business Officer Molly Harper will provide a company presentation on Wednesday, May 25, 2022 at 10:30 am ET during the H.C. Wainwright Global Investment Conference taking place from May 23- 26, 2022 in Miami, Florida.



BIO International Convention. Synlogic will participate in the BIO International Convention taking place from June 13-16, 2022 in San Diego, California, including a company presentation by Ms. Harper.

Live webcasts of the presentations, if available, will be accessible under the “Event Calendar” in the Investors & Media section of the Synlogic website. Archived versions will be available afterwards at the same location.

Conference Call & Webcast Information

Synlogic will host a conference call and live webcast at 8:30 a.m. ET today, May 12, 2022. To access the live webcast, please visit the “Event Calendar” page within the Investors and Media section of the Synlogic website. Investors may listen to the call by dialing +1 (844) 815-2882 from locations in the United States or (213) 660-0926 from outside the United States. The conference ID number is 5149412. A replay will be available for 30 days on the Investors and Media section of the Synlogic website.


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About Synlogic

Synlogic is a clinical-stage biotechnology company developing medicines through its proprietary approach to synthetic biology. Synlogic’s pipeline includes its lead program in phenylketonuria (PKU), which has demonstrated proof of concept, and additional novel drug candidates designed to treat homocystinuria (HCU) and enteric hyperoxaluria. The rapid advancement of these potential biotherapeutics, called Synthetic Biotics, has been enabled by Synlogic’s proprietary, reproducible, target-specific drug design. Synlogic uses programmable, precision genetic engineering of well-characterized probiotics to exert localized activity for therapeutic benefit, with a focus on metabolic and immunologic diseases. Synlogic is also working with Roche in a research collaboration focused on the discovery of a novel Synthetic Biotic for the treatment of inflammatory bowel disease and with Ginkgo Bioworks to include additional undisclosed preclinical assets, combining Synlogic’s approach to Synthetic Biotics with Ginkgo’s Codebase and Foundry services. For additional information visit www.synlogictx.com.

Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, clinical development plans, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “on track,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Synlogic may identify forward-looking statements. Examples of forward-looking statements, include, but are not limited to, statements regarding the potential of Synlogic’s approach to Synthetic Biotics to develop therapeutics to address a wide range of diseases including inborn errors of metabolism, metabolic diseases, and inflammatory and immune disorders; our expectations about sufficiency of our existing cash balance; the future clinical development of Synthetic Biotics; the approach Synlogic is taking to discover and develop novel therapeutics using synthetic biology; our research and other collaborations; and the expected timing of Synlogic’s clinical trials of SYNB1618, SYNB1934, SYNB1353 and SYNB8802 and availability of clinical trial data. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including: the uncertainties inherent in the clinical and preclinical development process; the ability of Synlogic to protect its intellectual property rights; and legislative, regulatory, political and economic developments, as well as those risks identified under the heading “Risk Factors” in Synlogic’s filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Synlogic’s current views with respect to future events. Synlogic anticipates that subsequent events and developments will cause its views to change. However, while Synlogic may elect to update these forward-looking statements in the future, Synlogic specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Synlogic’s view as of any date subsequent to the date hereof.


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Synlogic, Inc.

Condensed Consolidated Statements of Operations



(in thousands except share and per share data)    For the three months ended  
     March 31  
     2022     2021  


   $ 244     $ —    

Operating expenses


Research and development

     11,738       11,180  

General and administrative

     4,271       3,851  







Total operating expenses

     16,009       15,031  







Loss from operations

     (15,765     (15,031

Other income, net

     68       60  







Net loss

   $ (15,697   $ (14,971







Net loss per share - basic and diluted

   $ (0.22   $ (0.36







Weighted-average common shares used in computing net loss per share - basic and diluted

     71,969,007       41,545,050  








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Synlogic, Inc.

Condensed Consolidated Balance Sheets



(in thousands, except share data)              
     March 31,
     December 31,



Cash, cash equivalents, & marketable securities

   $ 120,518      $ 136,629  

Fixed assets

     9,082        9,088  

Other assets

     29,709        29,019  







Total assets

   $ 159,309      $ 174,736  







Liabilities and stockholders’ equity


Current liabilities

   $ 9,664      $ 10,080  

Long-term liabilities

     17,351        17,390  







Total liabilities

     27,015        27,470  







Total stockholders’ equity

     132,294        147,266  







Total liabilities and stockholders’ equity

   $ 159,309      $ 174,736  







Common stock and common stock equivalents


Common stock

     70,267,586        69,698,844  

Common stock warrants (pre-funded)

     2,548,117        2,548,117  







Total common stock

     72,815,703        72,246,961  



Bill Berry

Berry & Company Public Relations

Phone: 212-253-8881

Email: bberry@berrypr.com


Andrew Funderburk

Kendall Investor Relations

Phone: 617-401-9152

Email: afunderburk@kendallir.com


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