Synlogic(US:SYBX)2021-11-10 18:44Financial Data and Key Metrics Changes - Research and development expenses increased to $13.4 million for Q3 2021 from $10.5 million in Q3 2020, primarily due to clinical study activities related to SYNB1618 and SYNB8802 [46] - General and administrative expenses rose to $3.6 million in Q3 2021 compared to $3 million in Q3 2020 [47] - The company reported a consolidated net loss of $16 million or $0.29 per share for Q3 2021, compared to a net loss of $13.2 million or $0.36 per share for the same period in 2020 [47] - Revenue for Q3 2021 was $0.9 million, attributed to a collaboration with Roche, compared to no revenue in Q3 2020 [47] - Cash and cash equivalents at the end of Q3 2021 were $150.1 million, up from $100.4 million at the end of 2020, expected to fund operations into 2024 [48] Business Line Data and Key Metrics Changes - The lead asset SYNB1618 demonstrated a statistically significant reduction in plasma Phe levels in the Phase 3 SynPheny study, marking a significant milestone in PKU drug development [5][6] - SYNB8802 showed robust consumption of oxalates in the GI tract, indicating potential as a therapy for Enteric hyperoxaluria [7][42] - SYNB1353, a new oral metabolic program for homocystinuria, was unveiled, expanding the company's metabolic portfolio [9] Market Data and Key Metrics Changes - The PKU market is characterized by a significant unmet need, with many diagnosed patients not receiving treatment due to limitations of existing therapies [16][67] - Enteric hyperoxaluria affects approximately 75,000 to 90,000 patients in the U.S., with no current treatment options available [41] - The market for homocystinuria is dynamic, with a substantial population in need of effective therapies [56] Company Strategy and Development Direction - The company is focused on rare and niche metabolic diseases, leveraging its Synthetic Biotic platform to develop targeted therapies [10] - Plans to advance SYNB1934 into a pivotal Phase 3 study based on encouraging data from the SynPheny study [24][39] - The collaboration with Roche aims to develop a Synthetic Biotic medicine for inflammatory bowel disease, with positive initial milestones achieved [61] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical potential of the Synthetic Biotic platform, particularly in addressing unmet needs in PKU and other metabolic diseases [5][10] - The company is committed to advancing its clinical programs and expects to provide meaningful updates in the coming quarters [48][50] Other Important Information - The company has made significant progress in its metabolic portfolio, with ongoing studies and collaborations enhancing its development capabilities [10][39] - The management team emphasized the importance of patient feedback in shaping the development of new therapies [21] Q&A Session Summary Question: Can you comment on the new compound SYNB1353 for HCU and its market opportunity? - Management highlighted the potential of SYNB1353 to address elevated homocysteine levels and noted a substantial unmet need in the market [52][56] Question: What are the next steps after achieving the first milestone in the Roche collaboration? - The collaboration is in the discovery phase, with further milestones and negotiations expected as the program progresses [60][61] Question: What are the key drivers for adoption in the under-penetrated PKU market? - Management indicated that the low treatment rate is due to the limited efficacy of existing therapies, emphasizing the need for a viable treatment option [64][67] Question: How does SYNB1353 differ from other programs in the clinic? - The program leverages existing knowledge from the PKU platform, utilizing similar molecular components while focusing on different biological targets [70][72] Question: Will there be pediatric trials for SYNB1618? - Management confirmed plans to pursue pediatric development once regulatory alignment is achieved [81] Question: What are the next steps for SYNB8802 if proof of concept is demonstrated? - The company plans to expand into other underlying etiologies and will consider the best path forward based on data from the proof of concept study [83] Question: Does SYNB1934 fall under the Gingko collaboration? - Management clarified that SYNB1934 was developed prior to the Gingko collaboration and does not involve milestone or royalty obligations to Gingko [85]