On November 10, 2020 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need, reported financial results for the quarter ended September 30, 2020 (Press release, Synthetic Biologics, NOV 10, 2020, View Source [SID1234570630]).

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"During the third quarter, we remained sharply focused on executing our strategy to advance our portfolio of GI-focused clinical development programs while continuing to respond to the unprecedented global health and economic crisis sparked by the COVID-19 pandemic," said Steven A. Shallcross, Chief Executive and Financial Officer of Synthetic Biologics. "We were pleased to receive formal written notification from the U.S. Food and Drug Administration ("FDA") notifying the Company that the proposed Phase 1b/2a clinical study of SYN-004 (ribaxamase) in adult allogeneic hematopoietic cell transplant ("HCT") recipients may proceed per our originally submitted clinical program protocol. Initiation of the planned Phase 1b/2a clinical trial to be conducted by the Washington School of Medicine in St. Louis ("Washington University") is anticipated to commence during the first quarter of 2021, pandemic conditions permitting. Following the announcement of our expanded collaboration with Massachusetts General Hospital ("MGH"), we continued to make significant progress on our SYN-020 intestinal alkaline phosphatase (IAP) program, including establishing Phase 1-enabling assays and completion of the manufacturing of drug supply in support of the planned Phase 1 single ascending dose ("SAD") study in healthy volunteers. The Phase 1 SAD Study is intended to support the clinical development of SYN-020 in multiple indications, including an initial indication for the treatment of radiation enteropathy secondary to pelvic cancer therapy."

Mr. Shallcross continued, "During the third quarter, we announced the results of a planned interim futility analysis of the investigator-sponsored Phase 2b clinical study of SYN-010 being conducted by Cedars-Sinai Medical Center ("CSMC"). Although SYN-010 was well-tolerated, analysis of the interim data set concluded it was unlikely to meet its primary objective by the time enrollment was completed. On the basis of these findings, CSMC agreed to discontinue the trial and intends to conduct a comprehensive review of the final data set and publish its findings. While we’re disappointed by these results, we’re committed to working with our clinical development partners to advance SYN-004 and SYN-020. Both of these programs are unrelated to SYN-010, and therefore, we remain encouraged by the outlook and potential for these programs to address large, underserved markets. We continue to closely monitor the crisis caused by the spread of COVID-19 and look forward to sharing important updates and progress for our GI-focused clinical programs."

Clinical Development and Operational Update

Received written notification from the FDA informing the Company that the SYN-004 (ribaxamase) Phase 1b/2a clinical program in adult allogeneic hematopoietic cell transplant ("HCT") recipients may proceed per the submitted clinical program protocol (Q3 2020)
Initiation of the proposed Phase 1b/2a clinical trial to be conducted by the Washington University School of Medicine in St. Louis in adult allogeneic HCT recipients is anticipated to commence during Q1 2021, pandemic conditions permitting,
The Phase 1b/2a clinical trial will comprise a single center, randomized, double-blinded, placebo-controlled clinical trial of oral SYN-004 (ribaxamase) in up to 36 evaluable adult allogeneic HCT recipients,
The goal of this study is to evaluate the safety, tolerability and potential absorption into the systemic circulation (if any) of 150 mg oral SYN-004 (ribaxamase) administered to allogeneic HCT recipients four times per day who receive an IV beta-lactam antibiotic to treat fever;
Received a study-may-proceed letter from the FDA to conduct a Phase 1 single ascending dose ("SAD") study in healthy volunteers, designed to evaluate SYN-020 intestinal alkaline phosphatase ("IAP") for safety, tolerability, and pharmacokinetic parameters (Q3 2020)
The Phase 1 clinical program is intended to support the clinical development of SYN-020 in multiple indications, including an initial indication for the treatment and prevention of radiation enteropathy secondary to cancer therapy;
Announced the results of a planned interim futility analysis of the investigator-sponsored Phase 2b clinical study of SYN-010 being conducted by Cedars-Sinai Medical Center ("CSMC") (Q3 2020)
Based on the review of the interim analysis, it was concluded that although SYN-010 was well-tolerated, it is unlikely to meet its primary objective by the time enrollment is completed,
CSMC has discontinued the trial and will conduct a comprehensive review of the final data set and publish its findings,
On the basis of these results, the Company and CSMC have mutually decided to terminate the exclusive license agreement and clinical trial agreements relating to SYN-010. The patent rights previously licensed to the Company covering the use of SYN-010 will remain the property of CSMC;
Quarter Ended September 30, 2020 Financial Results

General and administrative expenses increased by 9% to $1.2 million for the three months ended September 30, 2020, from $1.1 million for the three months ended September 30, 2019. This increase is primarily due to increased insurance costs and stock registration fees, offset by a decrease in legal costs. The charge related to stock-based compensation expense was $67,000 for the three months ended September 30, 2020, compared to $68,000 the three months ended September 30, 2019.

Research and development expenses decreased by 78% to $0.9 million for the three months ended September 30, 2020, from $4.1 million for the three months ended September 30, 2019. This decrease is primarily the result of the response to the global COVID-19 pandemic by our clinical development partners which led to the postponement of the Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients, as well as the discontinuation of the Phase 2b investigator sponsored clinical trial of SYN-010. The charge related to stock-based compensation expense was $15,000 for the three months ended September 30, 2020, compared to $23,000 for the three months ended September 30, 2019.

Other income was $134 for the three months ended September 30, 2020, compared to other income of $92,000 for the three months ended September 30, 2019. Other income for the three months ended September 30, 2020 and 2019 is primarily comprised of interest income.

Cash and cash equivalents as of September 30, 2020 totaled $6.0 million, a decrease of $9.0 million from December 31, 2019.

Conference Call

Synthetic Biologics will hold a conference call today, Tuesday, November 10, 2020, at 4:30 p.m. (EST). The dial-in information for the call is as follows, U.S. toll free: 1-888-347-5280 or International: +1 412-902-4280. Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source An archive of the call will be available for replay at the same URL, View Source, for 90 days after the call.