UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 2.02 | Results of Operations and Financial Condition |
On March 17, 2022, Synlogic, Inc. (the “Company”) announced its financial results for the quarter and full year ended December 31, 2021. The full text of the press release and the subsequent presentation issued in connection with the announcement is furnished as Exhibit 99.1 and 99.2, respectively, to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K (including Exhibit 99.1 and 99.2) 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
| Exhibit No. |
Description | |
| 99.1 | Press Release dated March 17, 2022. | |
| 99.2 | Presentation dated March 17, 2022. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
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: March 17, 2022 | Synlogic, Inc. | |||||||
| By: | /s/ Gregg Beloff |
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| Name: | Gregg Beloff | |||||||
| Title: | Interim Chief Financial Officer | |||||||
Exhibit 99.1
Synlogic Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update
- Phenylketonuria (PKU) program on track for Phase 3 trial initiation in H2 2022 –
- Clinical readouts anticipated for PKU program in H1 2022 and in homocystinuria and enteric hyperoxaluria in H2 2022 –
- $136.6 million in cash, cash equivalents and marketable securities support projected runway into 2024 –
- Conference call and webcast at 8:30 a.m. ET today –
Cambridge, Mass. March 17, 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 fourth quarter and full year ending December 31, 2021 and provided an update on pipeline programs.
“2021 was a transformational year for Synlogic highlighted by proof of concept for our lead program in phenylketonuria (PKU),” said Aoife Brennan, M.B. Ch.B., Synlogic President and Chief Executive Officer. “Despite the devastating burden of this disease, a large majority of people living with PKU remain in need of an efficacious, safe, oral medication. We look forward to sharing Phase 2 data in the first half of this year as we continue plans to initiate Phase 3 later this year. We are also excited for clinical data readouts from our homocystinuria (HCU) and enteric hyperoxaluria programs, as well as research progress including our ongoing collaborations with Ginkgo Bioworks and Roche.”
Recent Portfolio Highlights
SYNB1618 and SYNB1934: In Development for the Treatment of PKU
| • | PKU is a rare metabolic disease that can result in irreversible cognitive and neurological damage. Approximately 75% of people with PKU remain untreated, reflecting limitations of current therapies. SYNB1618 and SYNB1934 are non-systemically absorbed, oral drug candidates being studied for both adjunctive and monotherapy treatment of PKU. |
| • | In September 2021, Synlogic reported positive interim results from the Phase 2 SynPheny-1 study for SYNB1618, with clinically meaningful and statistically significant reduction of plasma Phe levels in patients with PKU. Based on this achieved proof of concept, the Company began preparations for Phase 3 development. |
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| • | In parallel, Synlogic added an arm to the Phase 2 Synpheny-1 study for SYNB1934, a next-generation drug candidate for PKU designed for greater potency in Phe reduction. This additional arm in Synpheny-1 followed positive results with SYNB1934 in healthy volunteer studies. |
| • | In H1 2022, Synlogic expects to announce additional data from the Synpheny-1 study and, based on those findings, which of the two candidates will proceed to Phase 3 and potential commercialization. |
SYNB1353: In Development for the Treatment of HCU
| • | In November 2021, Synlogic and Ginkgo Bioworks announced the nomination of SYNB1353, a drug candidate designed to consume methionine for the treatment of HCU. Like PKU, HCU is an inherited rare metabolic disease caused by an inborn error of metabolism that results in significant disease burden, including intellectual disability and thromboembolism. |
| • | During 2022, the Company plans to submit an investigational new drug application (IND), initiate clinical trials and, in H2 2022, report Phase 1 healthy volunteer data for SYNB1353. |
SYNB8802: In Development for the Treatment of Enteric Hyperoxaluria
| • | Enteric hyperoxaluria, a leading cause of recurrent kidney stones, is a chronic, progressive disease that can lead to chronic kidney disease (CKD) and end-stage renal disease (ESRD), and for which there is currently no FDA-approved treatment. |
| • | Synlogic demonstrated proof of mechanism for SYNB8802 in enteric hyperoxaluria in 2021, and it is currently being evaluated in patients who have undergone Roux-en-Y gastric bypass surgery, with proof-of-concept data from this study expected in 2022. |
Preclinical Pipeline
| • | Synlogic plans to advance research programs to address metabolic and immunologic diseases, including wholly owned programs targeting inflammatory bowel disease and hyperuricemia (gout), diseases for which the Synthetic Biotic clinical profile of orally-administered, non-systemically absorbed biotherapeutics is particularly compelling. |
| • | The Company’s research collaboration with Roche to develop a Synthetic Biotic for the treatment of inflammatory bowel disease continues to progress. |
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| • | Synlogic and Ginkgo continue to advance their long-term strategic platform collaboration with multiple undisclosed metabolic and immunology programs now in preclinical development. |
Anticipated Upcoming Milestones
Rare Metabolic Diseases
| • | SYNB1618 and SYNB1934 for PKU |
| • Phase 2 SynPheny-1 study data |
H1 2022 | |
| • Phase 3 trial initiation |
H2 2022 | |
| • | SYNB1353 for homocystinuria (HCU) |
| • Data from Phase 1 trial in healthy volunteers |
H2 2022 |
Enteric Hyperoxaluria
| • | SYNB8802 for enteric hyperoxaluria |
| • Data from Phase 1b trial in patients with Roux-en-Y gastric bypass |
2022 |
Corporate Updates
Earlier this month, the company announced the appointment of Michael Jensen as Chief Financial Officer. Mr. Jensen brings extensive and diversified experience within global pharmaceutical and medical device companies to Synlogic, spanning analytics, financial management, information systems, and operations. Mr. Jensen was formerly the CFO of Intrinsic Therapeutics.
Fourth Quarter 2021 Financial Results
As of December 31, 2021, Synlogic had cash, cash equivalents, and marketable securities of $136.6 million.
Revenue was $0.6 million for the three months ended December 31, 2021. Revenue in 2021 was associated with the ongoing research collaboration with Roche for the discovery of a novel Synthetic Biotic medicine for the treatment of IBD. There was no revenue for the three months ended December 31, 2020.
Research and development expenses were $11.9 million for the three months ended December 31, 2021, compared to $11.4 million for the corresponding period in 2020.
General and administrative expenses for the three months ended December 31, 2021 were $3.9 million compared to $3.3 million for the corresponding period in 2020.
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For the three months ended December 31, 2021, Synlogic reported a consolidated net loss of $15.1 million, or $0.21 per share, compared to a consolidated net loss of $14.6 million, or $0.39 per share, for the corresponding period in 2020.
Full Year 2021 Financial Results
Revenues were $1.8 million for the year ended December 31, 2021, compared to $0.5 million for the same period in 2020. Revenue in 2021 was associated with the ongoing research collaboration with Roche for the discovery of a novel Synthetic Biotic medicine for the treatment of IBD. Revenue in 2020 was due to the prior collaboration with AbbVie, which was terminated in May 2020. Operating expenses were $62.5 million for the year ended December 31, 2021, compared to $61.0 million for the same period in 2020. For the year ended December 31, 2021, consolidated net loss was $60.6 million, or $1.09 per share, compared to a consolidated net loss of $59.2 million, or $1.65 per share, for the year ended December 31, 2020.
Financial Outlook
Based upon its current operating plan and balance sheet as of December 31, 2021, Synlogic expects to have sufficient cash to be able to fund operations into 2024.
Investor Conference Presentation
Today, Synlogic will participate in Oppenheimer’s 32nd Annual Healthcare Conference. Dr. Brennan will present virtually at 10:40 am ET.
A live webcast of the presentation will be accessible under the “Event Calendar” in the Investors & Media section of the Company’s website. An archived version will also be available after the presentation on the Synlogic website.
Conference Call & Webcast Information
Synlogic will host a conference call and live webcast at 8:30 a.m. ET today, March 17, 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 +1 (213) 660-0926 from outside the United States. The conference ID number is 1719849. 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 with plans to start a pivotal, Phase 3 study in the second half of 2022, 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
(unaudited)
| (in thousands,except share and per share data) | ||||||||||||||||
| For the three months ended | For the years ended | |||||||||||||||
| December 31 | December 31 | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue |
$ | 592 | $ | — | $ | 1,754 | $ | 545 | ||||||||
| Operating expenses |
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| Research and development |
11,873 | 11,407 | 47,127 | 47,474 | ||||||||||||
| General and administrative |
3,864 | 3,286 | 15,392 | 13,537 | ||||||||||||
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| Total operating expenses |
15,737 | 14,693 | 62,519 | 61,011 | ||||||||||||
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| Loss from operations |
(15,145 | ) | (14,693 | ) | (60,765 | ) | (60,466 | ) | ||||||||
| Other income, net |
56 | 105 | 204 | 1,293 | ||||||||||||
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| Net loss |
$ | (15,089 | ) | $ | (14,588 | ) | $ | (60,561 | ) | $ | (59,173 | ) | ||||
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| Net loss per share—basic and diluted |
$ | (0.21 | ) | $ | (0.39 | ) | $ | (1.09 | ) | $ | (1.65 | ) | ||||
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| Weighted-average common shares used in computing net loss per share—basic and diluted |
71,945, 538 | 37,792,966 | 55,329,711 | 35,835,744 | ||||||||||||
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Synlogic, Inc.
Condensed Consolidated Balance Sheets
(unaudited)
| (in thousands, except share data) | ||||||||
| December 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Assets |
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| Cash, cash equivalents, & marketable securities |
$ | 136,629 | $ | 100,444 | ||||
| Fixed assets |
9,088 | 10,776 | ||||||
| Other assets |
29,019 | 32,620 | ||||||
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| Total assets |
$ | 174,736 | $ | 143,840 | ||||
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| Liabilities and stockholders’ equity |
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| Current liabilities |
$ | 10,080 | $ | 8,301 | ||||
| Long-term liabilities |
17,390 | 20,404 | ||||||
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| Total liabilities |
27,470 | 28,705 | ||||||
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| Total stockholders’ equity |
147,266 | 115,135 | ||||||
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| Total liabilities and stockholders’ equity |
$ | 174,736 | $ | 143,840 | ||||
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| Common stock and common stock equivalents |
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| Common stock |
69,698,844 | 38,183,273 | ||||||
| Common stock warrants (pre-funded) |
2,548,117 | 2,548,117 | ||||||
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| Total common stock |
72,246,961 | 40,731,390 | ||||||
| MEDIA CONTACT: |
INVESTOR CONTACT: | |
| Bill Berry Berry & Company Public Relations Phone: 212-253-8881 Email: bberry@berrypr.com |
Andrew Funderburk Kendall Investor Phone: 617-401-9152 Email: afunderburk@kendallir.com | |
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Transforming Medicine through Synthetic Biology Q4 and Full Year 2021 Financial Results & Business Update March 17, 2022 Exhibit 99.2
Forward Looking Statements This presentation 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," "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, 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; 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 SEC. 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..
© 2020 SYNLOGIC. QU©AR2T0E1R9LYSYRNELSOUGLTICS.. AALLLL RRIIGGHHTTSS RREESSEERRVVEEDD.. || 33 Opening Remarks Dr. Aoife Brennan MB CHB President & CEO
PKU Proof of concept from Phase 2 interim analysis with lead candidate PKU Next generation candidate showed greater potency HCU 2nd rare metabolic disease drug candidate entered pre-IND studies HOX Achieved proof of mechanism in healthy volunteers IBD Established Roche collaboration, achieved first research milestone PKU Phase 2 data Æ H1 2022 PKU Phase 3 initiation Æ H2 2022 HCU Phase 1 data from healthy volunteers Æ H2 2022 Enteric hyperoxaluria proof of concept Æ 2022 Multiple Anticipated Milestones as PKU Program Approaches Phase 3 2021 2022
Synthetic Biotics: A New Paradigm of Biotherapeutics GI = gastrointestinal Well-characterized probiotic chassis Programable, precision genetic engineering + Targets validated biology in metabolic and immunological diseases Safe chassis, with >100 years of human experience Orally-administered convenience Reversible via rapid GI clearance Addressing rare and common diseases
PKU: Unique Opportunity for Value Creation PKU = phenylketonuria Significant unmet medical need - 75% of patients remain untreated De-risked path to registration Well-connected patient population at concentrated sites of care Differentiated profile established in POC Phase 3 initiation in H2 2022 expected
© 2020 SYNLOGIC. QU©AR2T0E1R9LYSYRNELSOUGLTICS.. AALLLL RRIIGGHHTTSS RREESSEERRVVEEDD.. || 33 PKU Opportunity Molly Harper Chief Business Officer
*Responsive to BH4 (tetrahydrobiopterin) = molecule that the body produces to act as a cofactor with PAH, the enzyme that is impaired in PKU. Sapropterin is a synthetic form of BH4. NPKUA; 2. Patient numbers for sapropterin, pegvaliase derived from Biomarin financials and disclosures YE 2020; 3. Synlogic Market Research 2021 and Levy 2020 4. U.S. Prescribing Information for Palynziq; REMS = Risk Evaluation and Mitigation Strategy ~75% remain untreated2 Limitations of Current Options Create Need for A New Approach in PKU OPPORTUNITY PKU Patients, US (n=17,000)1 pegvaliase sapropterin
Potentially Transformative Product Profile Efficacy Safety Oral administration Monotherapy or Adjunctive Use .Sources: Synlogic PKU Program Update, September 20, 20211, Synlogic Market Research 4Q 2021 Designed and Differentiated for PKU
© 2020 SYNLOGIC. QU©AR2T0E1R9LYSYRNELSOUGLTICS.. AALLLL RRIIGGHHTTSS RREESSEERRVVEEDD.. || 33 PKU Clinical Development Dr. Aoife Brennan MB CHB President & CEO
With POC Established, PKU Program Has Path to Phase 3 in 2022 September 2021 SYNB1618: POC established SYNB1934: Greater potency confirmed Phase 3: Committed based on strength of POC H1 2022* SYNB1618: Complete Phase 2 dataset SYNB1934: PKU patient data Monotherapy and adjunctive use data Phase 3 drug candidate treatment data H2 2022* End-of-Phase 2 Meeting Phase 3 initiation * Anticipated Milestones
Regulatory Path De-Risked at Multiple Levels Disease Precedents in two FDA-approved drugs Platform Synthetic Biotics Drug Candidate SYNB1618/SYNB1934
© 2020 SYNLOGIC. QU©AR2T0E1R9LYSYRNELSOUGLTICS.. AALLLL RRIIGGHHTTSS RREESSEERRVVEEDD.. || 33 Enteric Hyperoxaluria, Homocystinuria and Preclinical Programs Dave Hava, PhD Chief Scientific Officer
SYNB1353 for HCU: 2nd Rare Metabolic Disease Program Significant disease burden Builds on PKU success Strong synergies with PKU Gut lumen Methionine SYNB1353 Intestinal epithelium CBS = cystathionine beta-synthase 1. Development of an Investigational Methionine-consuming Synthetic Biotic Medicine (SYNB1353) for the Treatment of Homocystinuria, International Congress of Inborn Errors of Metabolism, November 23, 2021 3-MTP SYNB1353: Methionine-Consuming Drug Candidate for HCU
SYNB8802 for Enteric Hyperoxaluria: On Track for POC in 2022 GI = gastrointestinal, CKD = chronic kidney disease, ESRD = end stage renal disease Acute Crises, Long-Term Damage Stomach Small Intestine Colon Consumes Oxalate Across GI Tract Dietary Oxalate SYNB8802
Platform’s Progress Has Enabled Research Programs in New Areas Immunological disease SYNB1618 Phe SYNB8802 Oxalate metabolism SYNB1934 Phe SYNB1353 Methionine Metabolic disease
Strength of Partners Reflects Platform Progress and Potential IND = Investigational New Drug
© 2020 SYNLOGIC. QU©AR2T0E1R9LYSYRNELSOUGLTICS.. AALLLL RRIIGGHHTTSS RREESSEERRVVEEDD.. || 33 Financial Summary Michael Jensen Chief Financial Officer
Balance Sheet (unaudited) 31 December 2021 31 December 2020 Cash, Cash Equivalents, and Marketable Securities $136.6 M $100.4 M * weighted average shares used in computing net loss per shares - basic and diluted Fourth Quarter and Year End 2021 Summary Results Financial Performance (unaudited) 31 Dec 2021 31 Dec 2020 31 Dec 2021 31 Dec 2020 Revenue $0.6 M - 1.8 M 0.5 M R&D Expenses $11.9 M $11.4 M $47.1 M $47.5 M G&A Expenses $3.9 M $3.3 M $15.4 M $13.5 M Net Loss $(15.1 M) $(14.6 M) $(60.6 M) $(59.2 M) Net Loss per share – basic and diluted* $(0.21) $(0.39) (1.09) (1.65) Weighted Average Shares Outstanding* 71.9 M 37.8 M 55.3 M 35.8 M
© 2020 SYNLOGIC. QU©AR2TE1R9LYSYRNELSOUGLTICS.. AALLLL RRIIGGHHTTSS RREESSEERRVVEEDD.. || 1414 Concluding Remarks Dr. Aoife Brennan MB CHB President & CEO
PKU Phase 2 data readout Æ H1 2022 PKU Phase 3 initiation Æ H2 2022 HCU Phase 1 data from healthy volunteers Æ H2 2022 Enteric hyperoxaluria proof of concept Æ 2022 Multiple Expected Near-Term Milestones Strong balance sheet: $136.6m* with projected runway into 2024 * As of December 31, 2021
Available For Questions Dave Hava, PhD Chief Scientific Officer Michael Jensen Chief Financial Officer Aoife Brennan, MB ChB President & CEO Antoine Awad Chief Operating Officer Molly Harper Chief Business Officer