Full Press Release Details
Synthetic Biologics Reports Second Quarter 2021
Operational Highlights and Financial Results;
Conference Call to be Held Today at 4:30 PM
Phase 1 Single-Ascending Dose Clinical Trial
of SYN-020 Demonstrated Favorable Safety Profile
and was Well Tolerated at All Dose Levels; A
Second Phase 1 Multiple-Ascending Dose Clinical Trial Expected to Commence in Q3 2021
Enrollment in Phase 1b/2a Clinical Trial of
SYN-004 in Allogeneic HCT Recipients Proceeding as Planned
Reports $74.3 Million of Cash on Hand to Fund
Clinical Programs Through Key Milestones Beyond 2022
MD, August 5, 2021 - 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, today provided a clinical programs update and reported financial
results for the second quarter ended June 30, 2021.
Recent Developments:
Anticipated Milestones:
"During the second quarter, we remained
focused on the advancement of our portfolio of gastrointestinal and microbiome-focused clinical programs," said Steven A. Shallcross,
Chief Executive Officer of Synthetic Biologics. "We were pleased to complete patient dosing and observation in the Phase 1 SAD clinical
trial of SYN-020 intestinal alkaline phosphatase with preliminary results demonstrating that SYN-020 maintained a favorable safety profile,
was well tolerated at all dose levels, and no adverse events were attributed to SYN-020. Looking ahead, we intend to commence a second
Phase 1 MAD clinical trial of SYN-020 in healthy adult volunteers during the third quarter of 2021 with topline results expected during
the second quarter of 2022. Both the Phase 1 SAD and MAD studies are designed to support the advancement of SYN-020 in multiple potential
therapeutic indications, including celiac disease, nonalcoholic fatty liver disease ("NAFLD"), radiation enteritis, and age-related
metabolic and inflammatory diseases."
Mr. Shallcross continued, "Patient screening
and enrollment in the SYN-004 Phase 1b/2a clinical trial in allogeneic HCT recipients remains ongoing at the Washington University School
of Medicine in St. Louis ("Washington University"). At this time, enrollment is proceeding as expected and we anticipate announcing
topline results from this first of three antibiotic cohorts during the fourth quarter of 2021. We believe SYN-004 has the potential to
significantly improve outcomes for allogeneic HCT recipients by preventing downstream complications often caused by disruption of the
gut microbiome by intravenous ("IV") beta-lactam antibiotics following conditioning therapy. We are very excited about the
potential for our portfolio of clinical development programs to be long-term value drivers for our Company and look forward to sharing
important updates as they become available."
Clinical Development and Operational Update
Quarter Ended June 30, 2021 Financial Results
General and administrative expenses decreased
by 2% to approximately $1.26 million for the three months ended June 30, 2021, from approximately $1.29 million for the three months ended
June 30, 2020. This decrease is primarily due to lower legal costs and vacation expense offset by higher insurance costs, audit fees and
registration fees. The charge related to stock-based compensation expense was $83,000 for the three months ended June 30, 2021, compared
to $67,000 for the three months ended June 30, 2020.
Research and development expenses increased
by 21% to approximately $1.9 million for the three months ended June 30, 2021, from approximately $1.6 million for the three months
ended June 30, 2020. This increase is primarily the result of increased clinical trial expenses as we began dosing patients in the
Phase 1b/2a clinical trial of SYN-004 and Phase 1 SAD clinical trial of SYN-020 during the three months ended June 30, 2021, offset
by lower indirect program costs for the three months ended June 30, 2021, including salary and related expense reductions, a
decrease in manufacturing costs for SYN-020 and market research. In addition, as a result of the global COVID-19 pandemic, our
clinical development partner (Washington University) reduced their operating capacity during 2020 to include only essential
activities as part of their pandemic response, which delayed the start of our clinical trial until 2021. We anticipate research and
development expense to increase as our ongoing clinical trials continue to enroll patients. The charge related to stock-based
compensation expense was $19,000 for the three months ended June 30, 2021, compared to $19,000 related to stock-based compensation
expense for the three months ended June 30, 2020.
Other income was $2,000 for the three months ended
June 30, 2021, compared to other income of $6,000 for the three months ended June 30, 2020. Other income for the three months ended June
30, 2021 and 2020 is primarily comprised of interest income.
Cash and cash equivalents as of June 30, 2021
totaled $74.3 million, an increase of $68.1 million from December 31, 2020.
Synthetic Biologics will hold a conference call
today, Thursday, August 5, 2021, 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 https://www.webcaster4.com/Webcast/Page/1096/41790. An archive of the call will be available for replay at the same URL, https://www.webcaster4.com/Webcast/Page/1096/41790
, for 90 days after the call.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE American: SYN)
is 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. The Company's lead candidates are: (1) SYN-004 (ribaxamase) which is designed to degrade
certain commonly used intravenous (IV) beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent (a) microbiome damage,
(b) Clostridioides difficile infection (CDI), (c) overgrowth of pathogenic organisms, (d) the emergence of antimicrobial resistance
(AMR), and (e) acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients, and (2) SYN-020,
a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat
both local GI and systemic diseases. For more information, please visit Synthetic Biologics' website at www.syntheticbiologics.com.
This release contains forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified
by terminology such as "may," "should," "potential," "continue," "expects," "anticipates,"
"intends," "plans," "believes," "estimates," and similar expressions, and include statements regarding
the current cash runway providing funding to complete the Phase 1b/2a clinical trial of SYN-004, clinical trials of SYN-020 through proof-of-concept,
and other key milestones into 2023, the Phase 1 clinical trials of SYN-020 supporting development of SYN-020 in multiple potential clinical
indications, commencing a second Phase 1 multiple ascending-dose ("MAD") study of SYN-020 during Q3 2021 and topline data
anticipated during Q2 2022, a topline data readout from the first of three antibiotic cohorts of the SYN-004 Phase 1b/2a clinical trial
during Q4 2021, SYN-004 having the potential to significantly improve outcomes for allogeneic HCT recipients by preventing downstream
complications often associated with disruption of the gut microbiome by intravenous ("IV") beta-lactam antibiotics following
conditioning therapy. These forward-looking statements are based on management's expectations and assumptions as of the date of
this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual
results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements.
Important factors that could cause actual results to differ materially from current expectations include, among others, a failure to receive
the necessary regulatory approvals for commercialization of Synthetic Biologics' therapeutics, a failure of Synthetic Biologics'
clinical trials for SYN-004 and SYN-020 to be completed on time, to provide topline data when anticipated or to achieve desired results
and benefits, especially in light of COVID-19, a failure of Synthetic Biologics' clinical trials to continue enrollment as expected
or receive anticipated funding, a failure of Synthetic Biologics to successfully develop, market or sell its products, Synthetic Biologics'
inability to maintain its material licensing agreements, or a failure by Synthetic Biologics or its strategic partners to successfully
commercialize products and other factors described in Synthetic Biologics' Annual Report on Form 10-K for the year ended December
31, 2020 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. The information in this release
is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements
contained in this release on account of new information, future events, or otherwise, except as required by law.
For further information, please contact:
Synthetic Biologics, Inc. (Corporate and Investors)
Vincent I. Perrone, Director Corporate Communication, (240) 660-2000,
Gregory Kelley, Senior Vice President, (404) 836-2302, gregory.kelley@ogilvy.com