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Synthetic Biologics Reports 2020 Second Quarter Operational Highlights and Financial Results -- Announced FDA Clearance of IND Application for SYN-020 Intestinal Alkaline Phosphatase (IAP) -- -- Signed Option License Agr

Key Takeaway: Synthetic Biologics Reports 2020 Second Quarter Operational Highlights and Financial Results -- Announced FDA Clearance of IND Application for SYN-020 Intestinal Alkaline Phosphatase (IAP) -- -- Signed Option License Agreement with Massachusetts General Hospital to Develop S

Full Press Release Details

Synthetic Biologics Reports 2020 Second
Quarter Operational Highlights and Financial Results
-- Announced FDA Clearance of IND
Application for SYN-020 Intestinal Alkaline Phosphatase (IAP) --
-- Signed Option License Agreement
with Massachusetts General Hospital to Develop SYN-020
to Treat and Prevent Metabolic and
Inflammatory Diseases Associated with Aging --
-- Enrollment in the Phase 2b Investigator-Sponsored
Clinical Trial of SYN-010 Has Recommenced
Following COVID-19-Related Postponement
-- Conference Call Today at 4:30 p.m.
MD, August 6, 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, today provided a clinical programs update and reported
financial results for the quarter ended June 30, 2020.
"During the second quarter, we remained
diligently focused on advancing our portfolio of GI and microbiome-focused clinical development programs while continuing to navigate
the unprecedented global health and economic crisis sparked by the COVID-19 global pandemic," said Steven A. Shallcross,
Chief Executive and Financial Officer of Synthetic Biologics. "We made significant progress positioning SYN-020, our orally
delivered recombinant version of bovine intestinal alkaline phosphatase (IAP), for its first clinical trial. We were pleased to
report the FDA responded to our Investigational New Drug application (IND) with a study-may-proceed letter to conduct a Phase
1 single ascending dose study of SYN-020 in healthy volunteers. Additionally, we expanded our collaboration with Massachusetts
General Hospital (MGH) in the form of an exclusive option agreement to license intellectual property and technology to commercially
develop SYN-020 for the treatment and prevention of metabolic and inflammatory diseases associated with aging. The Phase 1 clinical
trial 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 and indications that may be developed under the MGH
Mr. Shallcross continued, "Enrollment in the Phase 2b
investigator-sponsored clinical trial of SYN-010, intended to treat irritable bowel syndrome-constipation (IBS-C) and being conducted
out of Cedars-Sinai Medical Center (CSMC), has recommenced following a temporary postponement during the first and second quarter
due to the impact of the COVID-19 global pandemic. A data readout in the form of an interim futility analysis is expected during
the third quarter and topline data is anticipated during the first quarter of 2021, subject to potential COVID-19 complications."
Mr. Shallcross concluded, "We remain in close contact with Washington University as we continue to evaluate opportunities
to initiate the planned Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients
in the face of the ongoing COVID-19 pandemic. We continue to closely monitor the crisis caused by the spread of the COVID-19 and
look forward to sharing important updates and progress for this and all our GI and microbiome-focused clinical programs."
Clinical Development and Operational
o Received study-may-proceed letter from FDA to conduct a Phase 1 single ascending dose study in healthy volunteers, designed to evaluate SYN-020 for safety, tolerability, and pharmacokinetic parameters (Q3 2020),
o 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;
Quarter Ended June 30, 2020 Financial
General and administrative expenses increased
by 23% to $1.3 million for the three months ended June 30, 2020, from $1.0 million for the three months ended June 30, 2019. This
increase is primarily due to increased legal costs related to business development, patent execution and employee contract matters,
vacation expense, and insurance costs. The charge related to stock-based compensation expense was $67,000 for the three months
ended June 30, 2020, compared to $59,000 the three months ended June 30, 2019.
Research and development expenses decreased
by 38% to $1.6 million for the three months ended June 30, 2020, from $2.6 million for the three months ended June 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 and a temporary halt
during the second quarter in new enrollment in the Phase 2b investigator sponsored clinical trial of SYN-010. The charge related
to stock-based compensation expense was $19,000 for the three months ended June 30, 2020, compared to $31,000 for the three months
ended June 30, 2019.
Other income was $6,000 for the three months
ended June 30, 2020, compared to other income of $80,000 for the three months ended June 30, 2019. Other income for the three months
ended June 30, 2020 and 2019 is primarily comprised of interest income.
Cash and cash equivalents as of June 30,
2020 totaled $8.1 million, a decrease of $7.0 million from December 31, 2019.
Synthetic Biologics will hold a conference call today, Thursday,
August 6, 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 https://www.webcaster4.com/Webcast/Page/1096/35797.
An archive of the call will be available for replay at the same URL, https://www.webcaster4.com/Webcast/Page/1096/35797,
for 90 days after the call.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE American:
SYN) is a 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 clinical 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 microbiome
damage, C. difficile infection (CDI), overgrowth of pathogenic organisms, the emergence of antimicrobial resistance (AMR)
and acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients, and (2) SYN-010, which
is intended to reduce the impact of methane-producing organisms in the gut microbiome to treat an underlying cause of irritable
bowel syndrome with constipation (IBS-C). The Company is also advancing SYN-020, an oral formulation of the enzyme intestinal
alkaline phosphatase (IAP) to treat both local GI and systemic diseases. For more information, please visit Synthetic Biologics'
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 Phase 1 clinical trial of SYN-020 supporting the clinical development of SYN-020 in multiple
indications, a data readout in the investigator-sponsored Phase 2b clinical trial of SYN-010 in the form of an interim futility
analysis during the third quarter and topline data during the first quarter of 2021, subject to potential COVID-19 complications,
and use of the license with MGH in the advancement of an expanded clinical development program for SYN-020. 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, and those conducted by investigators, for SYN-004, SYN-010 and SYN-020 to be commenced or completed on time 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, a failure to maintain
our listing on the NYSE American, 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,
2019 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
Vincent I. Perrone, Director Corporate Communication, (240)
Gregory Kelley, Senior Vice President, (404) 836-2302, gregory.kelley@ogilvy.com
Last updated: Aug 6, 2020