ROCKVILLE, Md., May 5, 2020 /PRNewswire/ -- 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 March 31, 2020.
"During the first quarter of 2020, we remained sharply focused
on executing our strategy to advance our portfolio of GI and
microbiome-focused clinical development programs while responding
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. "Recommendations by local governments,
hospitals and healthcare organizations to concentrate resources
towards COVID-19 care are having a material impact on ongoing and
planned clinical trials. This includes our ongoing Phase
2b investigator-sponsored clinical
trial of SYN-010, intended to treat irritable bowel syndrome with
constipation (IBS-C), being conducted out of Cedars-Sinai Medical
Center (CSMC), as well as our planned Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in
allogeneic hematopoietic cell transplant (HCT) recipients, which
will be conducted by the Washington
University School of Medicine in St. Louis (Washington
University). Although we have experienced additional delays
in enrollment and site visits for our planned and ongoing clinical
trials, we believe we have implemented an operational framework
which will allow us to navigate this crisis and ultimately deliver
on the tangible results and goals we have established for our
company."
Mr. Shallcross continued, "During the first quarter, we
continued to make significant progress towards the completion of
Investigational New Drug (IND)-enabling toxicology studies and
assay development that are expected to support the filing of an IND
for our SYN-020 intestinal alkaline phosphatase (IAP) program
during the second quarter of 2020." Mr. Shallcross concluded, "In
response to the efforts undertaken by our clinical development
partners to conserve resources for combatting COVID-19, we have
been able to reduce our burn rate and further extend our cash
runway through at least the first quarter of 2021. We are
monitoring the crisis caused by the spread of the COVID-19 closely
and remain dedicated to protecting the health and safety of our
employees, our clinical development partners and our patients."
Clinical Development and Operational
Update
- Received official meeting minutes from the U.S. Food & Drug
Administration (FDA) in Q1 2020 following a Type-C meeting held at
the Company's request to discuss the development of a Phase
1b/2a clinical trial of SYN-004
(ribaxamase) in 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,
- Study participants will be enrolled into three sequential
cohorts administered a different study-assigned IV beta-lactam
antibiotic. Eight participants in each cohort will receive SYN-004
(ribaxamase) and four will receive placebo,
- Due to the unique challenges posed by the global COVID-19
pandemic, Washington University has
temporarily limited all non-essential activities, which directly
impacts planned clinical trials. As a result, commencement of the
planned Phase 1b/2a clinical trial in
allogeneic HCT recipients is postponed until the first quarter of
2021, subject to the impact of COVID-19,
- Initiation of the clinical trial remains contingent upon
approval of the clinical trial protocol by the Washington University School of Medicine's
Institutional Review Board (IRB) and determination that the study
is safe-to-proceed by the FDA;
- Enrollment in the Phase 2b
investigator-sponsored clinical study of SYN-010 for the treatment
of IBS-C continued through most of the first quarter of 2020.
However, due to the unique challenges posed by the global COVID-19
pandemic, CSMC has temporarily limited all non-essential
activities, which directly impacts ongoing clinical trials
-
- As a result, additional enrollment in the Phase 2b investigator-sponsored clinical trial is
temporarily suspended until a time when the safety of the Company's
employees, the employees of its clinical development partners, and
study participants can be assured,
- Active study participants who did not complete the study prior
to the decision to halt all non-essential activities may elect to
complete the study as CSMC has taken steps to ensure proper data
collection from this group of patients,
- A data readout is anticipated during the third quarter of 2020,
subject to the impact of COVID-19,
- Cedars-Sinai Medical Center and Synthetic Biologics are
co-funding the study. The patent rights covering the use of SYN-010
are owned by Cedars-Sinai Medical Center and are exclusively
licensed by Cedars-Sinai Medical Center to Synthetic
Biologics;
- Made additional progress towards the completion of IND-enabling
toxicology studies and assay development that are expected to
support the advancement of SYN-020 (intestinal alkaline
phosphatase) into clinical trials targeting areas of significant
unmet medical need, including enterocolitis associated with
radiation therapy for cancer
-
- Anticipate filing a U.S. IND in Q2 2020;
- The Company has further extended its cash runway since its
clinical development partners (CSMC, Washington University) have reduced their operating
capacity to include only essential activities directed towards
combatting COVID-19, which excludes all planned and ongoing
clinical trials for the time being;
- As previously disclosed in its Annual Report on Form 10-K for
the fiscal year ended December 31,
2019, which was filed with the Securities and Exchange
Commission on February 20, 2020, the
Company's audited financial statements contained a going concern
explanatory paragraph in the audit opinion from its independent
registered public accounting firm. This announcement does not
represent any change or amendment to the Company's financial
statements or to its Annual Report on Form 10-K for the year ended
December 31, 2019.
Quarter Ended March 31, 2020
Financial Results
General and administrative expenses increased by 21% to
$1.4 million for the three months
ended March 31, 2020, from
$1.1 million for the three months
ended March 31, 2019. This increase
is primarily due to increased insurance costs, registration fees,
and legal costs. The charge related to stock-based compensation
expense was $65,000 for the three
months ended March 31, 2020, compared
to $65,000 the three months ended
March 31, 2019.
Research and development expenses decreased by 32% to
$1.6 million for the three months
ended March 31, 2020, from
$2.4 million for the three months
ended March 31, 2019. This decrease
is primarily the result of lower indirect program costs for the
three months ended March 31, 2020,
including salary and related expense reductions resulting from the
2019 headcount reductions and a decrease in manufacturing costs for
SYN-020. The research and development costs incurred during the
quarter were primarily related to the investigator-sponsored Phase
2b clinical study of SYN-010. We
anticipate research and development expense to decrease as a result
of the response to the global COVID-19 pandemic by our clinical
development partners which has led to the postponement of the Phase
1b/2a clinical trial of SYN-004
(ribaxamase) in allogeneic HCT recipients and a temporary halt in
new enrollment in the Phase 2b
investigator sponsored clinical trial of SYN-010. The
charge related to stock-based compensation expense was $18,000 for the three months ended March 31, 2020, compared to no charge related to
stock-based compensation expense for the three months ended
March 31, 2019 resulting from the
2018 restructuring.
Other income was $38,000 for the
three months ended March 31, 2020,
compared to other income of $44,000
for the three months ended March 31,
2019. Other income for the three months ended March 31, 2020 and 2019 is primarily comprised of
interest income.
Cash and cash equivalents as of March 31,
2020 totaled $10.1 million, a
decrease of $5.0 million from
December 31, 2019.
Conference Call
Synthetic Biologics will hold a conference call today,
Tuesday, May 5, 2020, at 4:30 p.m.
(EDT). 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/1096/34417. An archive of
the call will be available for replay at the same URL,
https://www.webcaster4.com/Webcast/Page/1096/34417, 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' 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 commencement of the planned Phase 1b/2a investigator-sponsored clinical study in
allogeneic HCT patients in the first quarter of 2021, anticipated
data readout for the investigator-sponsored Phase 2b clinical study for SYN-010 during the third
quarter of 2020, anticipated IND filing for SYN-020 in the
second quarter of 2020, SYN-004's degrading certain
commonly used intravenous (IV) beta-lactam antibiotics within the
gastrointestinal tract to prevent microbiome damage, C. difficile
infection, overgrowth of pathogenic organisms, the emergence of
antimicrobial resistance (AMR) and acute graft-versus-host-disease
in allogeneic hematopoietic cell transplant (HCT) recipients, and
SYN-010 reducing the impact of methane-producing organisms in the
gut microbiome to treat an underlying cause of irritable bowel
syndrome with constipation. 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 and SYN-010 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,
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.
- Financial Tables Follow -
Synthetic
Biologics, Inc. and Subsidiaries
|
(in thousands,
except share and per share amounts)
|
|
Consolidated
Balance Sheets
|
|
For the three
months ends
March
31,
|
|
2020
|
|
2019
|
Assets
|
|
|
|
Cash and
cash equivalents
|
$
10,085
|
|
$
15,045
|
Prepaid
expenses and other current assets
|
1,084
|
|
1,381
|
Property
and equipment, net
|
309
|
|
367
|
Right of
Use Asset
|
386
|
|
419
|
Deposits
and other assets
|
23
|
|
23
|
Total
Assets
|
$
11,887
|
|
$
17,235
|
Liabilities and
Stockholder's Deficit
|
|
|
|
Total
liabilities
|
$
3,281
|
|
$
5,748
|
Series A
Convertible Preferred Stock
|
12,606
|
|
12,544
|
Synthetic Biologics,
Inc. and Subsidiaries Equity (Deficit)
|
(1,122)
|
|
1,821
|
Non-controlling
interest
|
(2,878)
|
|
(2,878)
|
Total Liabilities
and Stockholders' Equity (Deficit)
|
$
11,887
|
|
$
17,235
|
|
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations
|
|
|
|
|
For the three
months ended
March 31,
|
|
|
2020
|
|
2019
|
Operating Costs
and Expenses
|
|
|
|
|
General
and administrative
|
|
$
1,393
|
|
$
1,154
|
Research
and development
|
|
1,635
|
|
2,418
|
Total Operating
Costs and Expenses
|
|
3,028
|
|
3,572
|
Loss from
Operations
|
|
(3,028)
|
|
(3,572)
|
Other
Income
|
|
|
|
|
Interest
income
|
|
38
|
|
44
|
Total Other
Income
|
|
38
|
|
44
|
Net
Loss
|
|
(2,990)
|
|
(3,528)
|
Net Loss
Attributable to Non-controlling Interest
|
|
(26)
|
|
(16)
|
Net Loss
Attributable to Synthetic Biologics, Inc.
and
Subsidiaries
|
|
$
(2,964)
|
|
$
(3,512)
|
Series A Preferred
Stock Dividends
|
|
(62)
|
|
(61)
|
Series B Preferred
Stock Dividends
|
|
(404)
|
|
(398)
|
Net Loss
Attributable to Common Stockholders
|
|
(3,430)
|
|
(3,971)
|
Net Loss Per Share
- Basic and Dilutive
|
|
$
(0.20)
|
|
$
(0.25)
|
Weighted average
number of common shares outstanding -
Basic and Dilutive
|
|
17,093,920
|
|
15,656,784
|
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SOURCE Synthetic Biologics, Inc.