Synlogic Reports First Quarter 2022 Financial Results and Business Update

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Synlogic, Inc.

– Advance Clinical Readouts 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 to support the projected track through 2024 –

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

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

“We are delighted to share this progress as we seek to advance our new Phenylketonuria (PKU) program towards Phase 3 initiation,” said Synlogic Chief Executive Officer Aoife Brennan, MB Ch.B. . “We believe we have a unique opportunity to advance a potential treatment for the 55,000 people with PKU worldwide, more than 75% of whom still need additional treatment options, either as monotherapy or as an add-on. We are pleased with the progress made in our additional programs with milestones expected in 2022, including our homocystinuria (HCU) and enteric hyperoxaluria programs, as well as research progress, including our ongoing collaborations with Ginkgo Bioworks and Rock.

Upcoming milestones planned

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

  • Initiate the Phase 3 trial for the PKU program in the first half of 2023 with Phase 3 readiness activities currently underway

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

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

Recent Business Highlights

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 new 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 amounted to $11.7 million for the quarter ended March 31, 2022, compared to $11.2 million for the corresponding period in 2021.

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

Financial outlook

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

Participation in the investor and industry conference

Synlogic will attend the following upcoming investor and industry conferences:

  • RBC Capital Markets Global Healthcare Conference. Dr. Brennan will present on Wednesday, May 18, 2022 at 8:30 a.m. ET at the RBC Capital Markets Global Healthcare conference being held in New York City May 17-18, 2022.

  • The HC Wainwright World Investment Conference. Chief Financial Officer Michael Jensen and Chief Commercial Officer Molly Harper will present the company on Wednesday, May 25, 2022 at 10:30 a.m. ET at the HC Wainwright Global Investment Conference taking place May 23-26, 2022 in Miami , in Florida.

  • International Organic Convention. Synlogic will be attending the BIO International Convention to be held June 13-16, 2022 in San Diego, CA with a company presentation by Ms. Harper.

Live webcasts of the presentations, if available, will be accessible under the “Calendar of Events” in the Investors & Media section of Synlogic’s website. Archived versions will then be available in the same place.

Conference Call and 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 “Calendar of Events” page in the Investors & Media section of the website. from Synlogic. Investors can listen to the call by dialing +1 (844) 815-2882 from within the United States or (213) 660-0926 from outside the United States. The call ID number is 5149412. A replay will be available for 30 days in the Investors and Media section of Synlogic’s website.

About Synlogic

Synlogic is a clinical-stage biotechnology company that develops drugs 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 new drug candidates designed to treat homocystinuria (HCU) and enteric hyperoxaluria. The rapid advancement of these potential biotherapies, called synthetic biotics, has been made possible by Synlogic’s proprietary, reproducible, and target-specific drug design. Synlogic uses programmable and precise genetic engineering of well-characterized probiotics to exert localized activity for therapeutic purposes, with an emphasis on metabolic and immunological diseases. Synlogic is also working with Roche on a research collaboration focused on the discovery of a new synthetic biotic for the treatment of inflammatory bowel disease and with Ginkgo Bioworks to include additional undisclosed preclinical actives, combining the Synlogic’s approach to synthetic biotics with Ginkgo’s Codebase and Foundry services. For more 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 fact, included in this press release regarding strategy, future operations, clinical development plans, future financial condition, future revenues, projected expenditures, prospects, plans and objectives of management are forward-looking statements. In addition, when used in this press release, the words “may”, “could”, “should”, “anticipate”, “believe”, “estimate”, “expect”, “on the track”, “intend”, “plan”, “predict”, and similar expressions and variations thereof, 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 therapies to treat a wide range of diseases, including inborn errors of metabolism, metabolic diseases and inflammatory and immune disorders; our expectations regarding the adequacy of our existing cash balance; the future clinical development of Synthetic Biotics; Synlogic’s approach to discovering and developing new therapies using synthetic biology; our research and other collaborations; and the anticipated timing of Synlogic’s clinical trials of SYNB1618, SYNB1934, SYNB1353 and SYNB8802 and the availability of clinical trial data. Actual results could differ materially from those contained in any forward-looking statements due to a variety of factors, including: uncertainties inherent in the clinical and preclinical development process; Synlogic’s ability to protect its intellectual property rights; and legislative, regulatory, political and economic developments, as well as risks identified under “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 beliefs regarding future events. Synlogic anticipates that subsequent events and developments will cause a change of opinion. However, while Synlogic may choose to update these forward-looking statements in the future, Synlogic specifically disclaims any obligation to do so. These forward-looking statements should not be taken to represent the views of Synlogic as of any date subsequent to the date hereof.

Synlogic, Inc.

Condensed Consolidated Statements of Earnings

(unaudited)

(in thousands except share and data per share)

For the three months ended

March, 31st

2022

2021

Revenue

$

244

$

Operating Expenses

Research and development

11,738

11,180

general and administrative

4,271

3,851

Total operating expenses

16,009

15,031

Operating loss

(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 the calculation of net loss per share – basic and diluted

71,969,007

41,545,050

Synlogic, Inc.

Condensed consolidated balance sheets

(unaudited)

(in thousands, except shared data)

March, 31st,
2022

The 31st of December,
2021

Assets

Cash, cash equivalents and negotiable 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 equity

Current liabilities

$

9,664

$

10,080

Long-term liabilities

17,351

17,390

Total responsibilities

27,015

27,470

Full shareholder equity

132,294

147,266

Total Liabilities and Equity

$

159 309

$

174,736

Common stock and common stock equivalents

Ordinary actions

70,267,586

69,698,844

Common stock warrants (pre-funded)

2,548,117

2,548,117

Total Common Shares

72 815 703

72,246,961


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