30, Inc. (NASDAQ:SYBX) Q3 2019 Earnings Conference Call November 12, 2019 5:00 PM ET Company Participants Elizabeth Wolffe - Head, IR & Corporate Communications Aoife Brennan - President, CEO & Director Gregg Beloff - Interim CFO, Pincipal Acounting Oficer & Principal Financial Officer Scott Plevy - Chief Scientific Officer Conference Call Participants Joori Park - SVB Leerink Samantha Semenkow - Citigroup Mark Breidenbach - Oppenheimer Edward Tenthoff - Piper Jaffray Companies Julian Harrison - BTIG Operat ...

SYNB1618 for Phenylketonuria (PKU) - SYNB1618 is being developed to manage Phe levels below target to prevent irreversible cognitive damage, increase natural protein intake (classic PKU patients' natural protein intake is typically less than 10g), and allow for oral dosing without systemic toxicity[16] - Phase 1/2a study demonstrated safety and clearance in healthy volunteers and PKU patients, with no treatment-related serious adverse events, systemic toxicity, or infections[28] - Single dose MTD in healthy volunteers was defined as 2x10^11 CFU, and a dose of 7x10^10 CFU TID over seven days was well-tolerated in PKU patients[28] - Modeling suggests potential for 8-18% to 57-131% blood Phe lowering with SYNB1618, depending on the dose and activity of PAL and LAAD pathways[36] - A bridging study with solid formulation was initiated in Q3 2019, and a Phase 2 study in PKU patients to assess Phe lowering is expected to start in 1H 2020[55] SYNB1891 in Immuno-Oncology - SYNB1891 is designed as a dual innate immune activator, combining a bacterial chassis and STING agonist (c-di-AMP) for efficacy and controlled safety[62] - In vitro characterization shows interferon production across multiple human STING alleles, with activity greater than naked STING agonist[66] - In vivo characterization demonstrates dose-dependent anti-tumor activity of SYNB1891 prototype strain (PT1) as a single agent[71] - IND for SYNB1891 has been cleared by the FDA, and Phase 1 monotherapy data is expected in 2020[76] General - For indications where immune checkpoint inhibitors are indicated, 55-87% of patients fail to respond[57]

Financial Data and Key Metrics Changes - Revenues for Q2 2019 were $0.4 million, an increase from $0.3 million in Q2 2018, primarily from collaboration with AbbVie [26] - Total operating expenses decreased to $13.4 million in Q2 2019 from $15.6 million in Q2 2018 [26] - Consolidated net loss for Q2 2019 was $12.3 million or $0.45 per share, compared to a net loss of $14.6 million or $0.59 per share in Q2 2018 [28] - Cash position at the end of Q2 2019 was $149.1 million, bolstered by a $50 million cash influx from the Ginkgo agreement [29] Business Line Data and Key Metrics Changes - Research and Development expenses were $9.7 million in Q2 2019, down from $10.9 million in Q2 2018, due to reduced clinical development costs for the SYNB1618 program [27] - General and administrative expenses decreased to $3.7 million in Q2 2019 from $4.7 million in Q2 2018 [28] Market Data and Key Metrics Changes - The company is focusing on metabolic diseases, particularly phenylketonuria (PKU) and hyperammonemia, with engineered strains SYNB1618 and SYNB1020 [11][12] - Collaboration with AbbVie aims to develop Synthetic Biotic medicines for inflammatory bowel disease (IBD) [13] Company Strategy and Development Direction - The company aims to develop a new class of living medicines using synthetic biology to address unmet medical needs [8][10] - A collaboration with Ginkgo Bioworks was established to enhance synthetic biology capabilities and optimize clinical candidates [19][22] - The company is prioritizing metabolic diseases and immunomodulation as key focus areas for future development [76] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of SYNB1618 and SYNB1020 programs, with expectations for upcoming clinical data [16][45] - The company is on track to file an IND application for SYNB1891 and anticipates significant advancements in its clinical programs [17][46] - Management highlighted the importance of understanding the behavior of engineered bacteria in human trials to inform future studies [31][38] Other Important Information - The company plans to present full data from the SYNB1618 study at the SSIEM symposium in September [34] - The collaboration with Ginkgo includes a commitment of $30 million for services over the next five years [22] Q&A Session Summary Question: Details on the bridging study for SYNB1618 - Management confirmed the bridging study will start with a well-tolerated dose and will dose escalate to identify the maximum tolerated dose [52][53] Question: Evidence for the new manufacturing process supporting tolerability - Management noted that while preclinical models do not provide direct evidence, tolerability data from the SYNB1020 program gives confidence in the new formulation [64] Question: Plans for assessing SYNB1891 as a monotherapy and in combination with Tecentriq - Management confirmed that SYNB1891 will be assessed first as a monotherapy, followed by combination therapy with Tecentriq [85][88] Question: Strategic intent for exploring synthetic biotic platform in diseases like IBD - Management emphasized the potential of the platform to address unmet needs in IBD and the importance of combination therapies for complex diseases [92][94] Question: Clarification on the optimization of the SYNB1618 profile - Management indicated that optimization efforts will focus on achieving the desired Phe lowering at tolerable doses, with ongoing studies to validate the approach [100][103]