ROCKVILLE, Md., March 4, 2021 /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
year ended December 31, 2020.
Recent developments:
- Received Institutional Review Board ("IRB") approval from
Washington University School of
Medicine in St. Louis for the
SYN-004 (ribaxamase) Phase 1b/2a
clinical trial protocol in allogeneic hematopoietic cell transplant
("HCT") recipients
- Commenced screening of patients for enrollment of the first of
three sequential antibiotic cohorts in the SYN-004 Phase
1b/2a clinical trial in allogeneic
HCT recipients
- Current cash position of approximately $72.6 million
- Received $8.0 million from the
exercise of warrants
- Current cash runway provides funding into 2023 and ability to
fully fund Phase 1b/2a clinical trial
of SYN-004 and Phase 1 safety studies of SYN-020 intestinal
alkaline phosphatase ("IAP") program
Upcoming milestones:
- Expect to begin dosing patients in the first antibiotic cohort
of the SYN-004 Phase 1b/2a clinical
trial during Q1 2021; A topline data readout of the first
antibiotic cohort is expected during Q4 2021
- Expect to commence first Phase 1 single-ascending-dose study
("SAD") of SYN-020 during Q2 2021; Topline data anticipated during
Q3 2021
- Expect to commence second Phase 1 multiple-ascending-dose
("MAD") study of SYN-020 during Q3 2021; Topline data anticipated
during Q2 2022
"We are more encouraged than ever by the outlook for the
business as we have made important progress during the fourth
quarter advancing and demonstrating the significant value of our
clinical development programs. With a number of upcoming catalysts
later this year, we believe there is potential to continue to
deliver significant value for our shareholders," stated
Steven A. Shallcross, Chief
Executive and Financial Officer. "IRB approval by Washington University of the SYN-004 Phase
1b/2a clinical program protocol marks
a major milestone for the Company. Looking ahead, we believe
SYN-004 has the potential to address an important and underserved
patient population, and may 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. We are pleased to
announce that Washington University has
begun screening patients for enrollment of the first of three
sequential antibiotic cohorts and look forward to reporting topline
data for this group towards the end of this year, pandemic
conditions permitting."
Mr. Shallcross continued, "During the fourth quarter of 2020, we
also made significant progress and gained additional clarity on
potential clinical development pathways for our SYN-020 IAP
program. Looking ahead, we intend to commence safety studies
starting with a planned Phase 1 single-ascending-dose study in
healthy volunteers during the second quarter of 2021; a topline
data readout is expected during the third quarter of 2021. A second
Phase 1 multiple-ascending-dose study is also expected to begin
enrollment during the third quarter of 2021. Both studies are
designed to support the advancement of SYN-020 in multiple
potential therapeutic indications, including celiac disease,
nonalcoholic fatty liver disease ("NAFLD") and age-related
metabolic and inflammatory diseases. We are very excited about the
potential for this program to be a long-term value driver for our
Company and look forward to sharing important updates and progress
as we continue to advance it towards clinical trials."
Mr. Shallcross concluded, "While remaining keenly focused on the
execution of our clinical development activities, we also
significantly strengthened our balance sheet and raised net
proceeds of approximately $63.8
million, in addition to $8.0
million in proceeds from the cash exercise of warrants,
which has helped to streamline our capital structure. As a result
of these activities, our current cash position is approximately
$72.6 million. Our fortified
financial footing will now allow the Company to continue its
operations into 2023 as well as fully fund the Phase 1b/2a clinical trial of SYN-004 and our planned
Phase 1 safety studies of SYN-020 IAP."
Clinical Development and Operational
Update
- Announced approval by the IRB at Washington University of the SYN-004 Phase
1b/2a clinical program protocol in
allogeneic HCT recipients, allowing the clinical trial to commence
as planned;
- Announced Washington University has
begun screening patients for enrollment of the first antibiotic
cohort for the Company's Phase 1b/2a
clinical trial of SYN-004 in allogeneic HCT recipients for the
prevention of acute graft-versus-host-disease (aGVHD)
-
- The Phase 1b/2a clinical trial
comprises a single center, randomized, double-blind,
placebo-controlled clinical trial of oral SYN-004 in up to 36
evaluable adult allogeneic HCT recipients,
- The goal of this clinical trial is to evaluate the safety,
tolerability and potential absorption into the systemic circulation
(if any) of oral SYN-004 administered to allogeneic HCT recipients
who receive an IV beta-lactam antibiotic to treat fever,
- Study participants will be enrolled into three sequential
cohorts and administered a different study-assigned IV beta-lactam
antibiotic. Eight participants in each cohort will receive SYN-004
and four will receive placebo,
- Safety and pharmacokinetic data for each cohort will be
reviewed by an independent Data and Safety Monitoring Committee
("DSMC"), which will make a recommendation on whether to proceed to
the next IV beta-lactam antibiotic,
- A topline data readout for the first antibiotic cohort is
anticipated during the fourth quarter of 2021, pandemic conditions
permitting;
- A Phase 1 SAD clinical trial in healthy volunteers of the
Company's SYN-020 IAP is anticipated to commence during the second
quarter of 2021
-
- A topline data readout is anticipated during the third quarter
of 2021, pandemic conditions permitting,
- A second Phase 1 clinical trial evaluating multiple-ascending
doses of SYN-020 in healthy volunteers is expected to commence
during the third quarter of 2021; topline data is anticipated
during the second quarter of 2022, pandemic conditions
permitting,
- Both studies are intended to support the development of SYN-020
in multiple potential clinical indications;
- Strengthened balance sheet by raising net proceeds of
$63.8 million from the sale of the
common stock via the Company's At-The-Market ("ATM") facility, and
$8.0 million resulting from the cash
exercise of a portion of Company's 2018 warrants
-
- As a result of these activities, the Company has extended its
cash runway into 2023 and has the ability to fully fund its Phase
1b/2a clinical trial of SYN-004 and
planned Phase 1 SAD and MAD clinical trials of SYN-020;
- Announced the appointment of senior biotech executive
John Monahan, PhD, to the Company's
Board of Directors
-
- Dr. Monahan brings to the Company more than 45 years of
executive leadership experience in the pharmaceutical and
biotechnologies industries.
Year Ended December 31, 2020
Financial Results
General and administrative expenses increased to $5.0 million for the year ended December 31, 2020, from $4.6 million for the year ended December 31, 2019. This increase of 8.7% is due
to increased legal costs related to business development, patent
execution, employee contract matters, vacation expense, insurance
costs and registration fees. The charge relating to stock-based
compensation expense was $300,000 for
the year ended December 31, 2020,
compared to $300,000 for the year
ended December 31, 2019.
Research and development expenses decreased to $5.1 million for the year ended December 31, 2020, from $11.1 million for the year ended December 31, 2019. This decrease of 54.1% is
primarily due to a reduction in preclinical and manufacturing
activity of SYN-020 IAP and 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 the SYN-010 clinical trial and to a
lesser extent the discontinuation of the Phase 2b investigator sponsored clinical trial of
SYN-010. Research and development expenses also include a charge
relating to non-cash stock-based compensation expense of
$66,000 for the year ended
December 31, 2020, compared to
$75,000 for the year ended
December 31, 2019.
Total other income was $44,000 for
the year ended December 31, 2020,
compared to other income of $283,000
for the year ended December 31, 2019.
Total other income for the year ended December 31, 2020 and 2019 is primarily comprised
of interest income from investments.
Cash and cash equivalents on December 31,
2020 were $6.2 million, a
decrease of $8.8 million from
December 31, 2019.
Conference Call
Synthetic Biologics will hold a conference call today,
Thursday, March 4, 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/1096/39984. An archive of
the call will be available for replay at the same URL,
https://www.webcaster4.com/Webcast/Page/1096/39984, 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 cash runway providing funding into 2023 and
the ability to fully fund the Phase 1b/2a clinical trial of SYN-004 and planned Phase
1 safety studies of SYN-020 intestinal alkaline phosphatase,
topline data of the first antibiotic cohort in the SYN-004 Phase
1b/2a clinical program being readout
during Q4 2021, commencing the first Phase 1 single-ascending-dose
study of SYN-020 during Q2 2021 and providing topline data during
Q3 2021, commencing the second Phase 1 multiple-ascending-dose
study of SYN-020 during Q3 2021 and providing topline data during
Q2 2022, continuing to deliver significant value for shareholders,
the potential of SYN-004 to address an important and underserved
patient population, and significantly improve outcomes for
allogeneic HCT recipients by preventing downstream complications
often associated with disruption of the gut microbiome by
intravenous beta-lactam antibiotics, and the potential for SYN-020
to be a long term value driver. 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-020 to be commenced or completed as planned, or a failure to
provide topline data when anticipated or to achieve desired results
and benefits, 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' most recent
Form 10-K 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
|
|
|
December
31,
|
|
2020
|
|
2019
|
Assets
|
|
|
|
Cash and
cash equivalents
|
$
6,227
|
|
$
15,045
|
Prepaid
expenses and other current assets
|
1,707
|
|
1,381
|
Property
and equipment, net
|
174
|
|
367
|
Right of
Use Asset
|
279
|
|
419
|
Deposits
and other assets
|
23
|
|
23
|
Total
Assets
|
$
8,410
|
|
$
17,235
|
Liabilities and
Stockholder's (Deficit) Equity
|
|
|
|
Total
liabilities
|
$
3,152
|
|
$
5,748
|
Series A
Convertible Preferred Stock
|
12,798
|
|
12,544
|
Synthetic Biologics, Inc. and Subsidiaries (Deficit)
Equity
|
(4,767)
|
|
1,821
|
Non-controlling interest
|
(2,773)
|
|
(2,878)
|
Total Liabilities
and Stockholders' (Deficit) Equity
|
$
8,410
|
|
$
17,235
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations
|
|
|
|
|
For the years
ended
December 31,
|
|
|
2020
|
|
2019
|
Operating Costs
and Expenses
|
|
|
|
|
General
and administrative
|
|
$
5,029
|
|
$
4,580
|
Research
and development
|
|
5,131
|
|
11,083
|
Total Operating
Costs and Expenses
|
|
10,160
|
|
15,663
|
Loss from
Operations
|
|
(10,160)
|
|
(15,663)
|
Other
Income
|
|
|
|
|
Interest
income
|
|
44
|
|
283
|
Total Other
Income
|
|
44
|
|
283
|
Net
Loss
|
|
(10,116)
|
|
(15,380)
|
Net Loss
Attributable to Non-controlling Interest
|
|
(73)
|
|
(77)
|
Net Loss
Attributable to Synthetic Biologics, Inc.
and
Subsidiaries
|
|
$
(10,043)
|
|
$
(15,303)
|
Series A Preferred
Stock Dividends
|
|
(254)
|
|
(248)
|
Series B Preferred
Stock Dividends
|
|
(1,380)
|
|
(525)
|
Effect of Warrant
Exercise price adjustment
|
|
(880)
|
|
-
|
Net Loss
Attributable to Common Stockholders
|
|
(12,557)
|
|
(16,076)
|
Net Loss Per Share
- Basic and Dilutive
|
|
$
(0.66)
|
|
$
(0.98)
|
Weighted average
number of common shares outstanding - Basic
and Dilutive
|
|
19,011,362
|
|
16,438,201
|
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SOURCE Synthetic Biologics, Inc.