ROCKVILLE, Md., Nov. 4, 2019 /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 an operational update and reported
financial results for the three and nine months ended September 30, 2019.
"During the third quarter, we remained sharply focused on the
advancement of our portfolio of GI-focused clinical programs which
leverage the microbiome to improve the health of patients," stated
Steven A. Shallcross, Chief
Executive and Financial Officer. "We were pleased to announce our
clinical trial collaboration with Washington
University School of Medicine in St. Louis ("Washington
University") to conduct a Phase 1b/2a clinical trial of SYN-004 (ribaxamase). The
announcement of this agreement is an important step in our pursuit
of a more cost-effective development strategy for our SYN-004
(ribaxamase) program aimed at improving clinical outcomes of
high-risk patients who undergo allogeneic hematopoietic cell
transplantation (HCT) and receive long courses of intravenous (IV)
beta-lactam antibiotics. Looking ahead, we intend to hold a Type-C
meeting with the U.S. Food & Drug Administration ("FDA") during
the fourth quarter to solidify the clinical protocol parameters for
this program with the intention of initiating enrollment during the
first quarter of 2020."
Mr. Shallcross continued, "Enrollment in our
investigator-sponsored Phase 2b
clinical study for SYN-010 in breath-methane positive irritable
bowel syndrome with constipation (IBS-C) patients remains ongoing.
We anticipate a data readout sometime during the first half of 2020
which we believe will further fortify the established clinical data
set for SYN-010 and support regulatory discussions to potentially
simplify future registration studies. For our SYN-020 intestinal
alkaline phosphatase (IAP) program, preclinical activities and
toxicology studies remain on track to support an Investigational
New Drug Application (IND) application filing during the first
quarter of 2020. We look forward to sharing important updates and
progress for this and all our GI and microbiome-focused clinical
programs."
Clinical Development and Operational Update
- Entered into a Clinical Trial Agreement with Washington University School of Medicine in
St. Louis to conduct a Phase
1b/2a clinical trial of SYN-004
(ribaxamase)
-
- Enrollment is expected to begin during the first quarter of
2020, contingent upon agreement with the FDA and approval of the
clinical study protocol by Washington
University's Institutional Review Board (IRB),
- The proposed study is a Phase 1b/2a single-center, randomized, double-blinded,
placebo-controlled clinical trial designed to evaluate the safety,
tolerability and pharmacokinetics of oral SYN-004 (ribaxamase) in
up to 36 adult allogeneic HCT recipients,
- Study participants will be enrolled into three sequential
cohorts that will be administered a different study-assigned IV
beta-lactam antibiotic. Eight participants in each cohort will
receive SYN-004 (ribaxamase) and four will receive placebo,
- Safety and pharmacokinetic data for each cohort will be
reviewed by an independent Data and Safety Monitoring Committee,
which will make a recommendation on whether to proceed to the next
IV beta-lactam antibiotic,
- The proposed study will also evaluate potential protective
effects of SYN-004 (ribaxamase) on the gut microbiome as well as
generate preliminary information on potential therapeutic benefits
and patient outcomes of SYN-004 (ribaxamase) in allogeneic HCT
recipients.
- Enrollment is ongoing in the Phase 2b investigator-sponsored clinical study of
SYN-010, for the treatment of IBS-C
-
- The Phase 2b clinical study is
being conducted by the Medically Associated Science and Technology
(MAST) Program at Cedars-Sinai Medical Center and is a 12-week,
placebo-controlled, double-blind, randomized clinical trial
evaluating two dose strengths of oral SYN-010 (21 mg and 42 mg) in
approximately 150 patients diagnosed with IBS-C,
- The primary objective for the study will be to determine the
efficacy of SYN-010, measured as an improvement from baseline in
the weekly average number of complete spontaneous bowel movements
(CSBMs) during the 12-week treatment period for SYN-010 21 mg and
42 mg daily doses relative to placebo,
- Secondary efficacy endpoints for both dose strengths of SYN-010
will measure changes from baseline in abdominal pain, bloating,
stool frequency as well as the use of rescue medication relative to
placebo,
- A data readout is anticipated in 1H 2020,
- 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;
- Evaluated potential clinical development strategies to advance
SYN-020 (intestinal alkaline phosphatase) to and through clinical
trials targeting areas of significant unmet medical need, including
enterocolitis associated with radiation therapy for cancer
-
- Anticipate filing a US IND in Q1 2020;
- Continued to exercise prudent cash management and financial
stewardship to further extend our cash runway through at least the
fourth quarter of 2020.
Quarter Ended September 30,
2019 Financial Results
General and administrative expenses decreased by approximately
26% to $1.1 million for the three
months ended September 30, 2019, from
$1.5 million for the three months
ended September 30, 2018. This
decrease is primarily due to decreased stock-based compensation
expense related to forfeitures and decreased option grants, along
with the reduction of investor relations and consulting costs. The
charge related to stock-based compensation expense was $68,000 for the three months ended September 30, 2019, compared to $186,000 the three months ended September 30, 2018.
Research and development expenses increased by approximately 46%
to $4.1 million for the three months
ended September 30, 2019 from
$2.8 million for the three months
ended September 30, 2018. This
increase is primarily the result of higher manufacturing and
pre-IND-enabling toxicology study costs for SYN-020 and the cost
incurred to co-fund the investigator-sponsored Phase 2b clinical study of SYN-010. Research and
development expenses also include a charge relating to stock-based
compensation expense of $22,000 for
the three months ended September 30,
2019, compared to $289,000 for
the three months ended September 30,
2018.
Other income was $92,000 for the
three months ended September 30,
2019, compared to other income of $631,000 for the three months ended September 30, 2018. Other income for the three
months ended September 30, 2019 is
primarily comprised of interest income while the three months ended
September 30, 2018 is comprised of
non-cash income of $626,000 from the
change in fair value of warrants. The decrease in the fair value of
the warrants was due to the decrease in our stock price.
Cash and cash equivalents as of September
30, 2019 totaled $18.7
million, a decrease of $10.3
million from December 31,
2018.
Conference Call
Synthetic Biologics will hold a conference call today, Monday, November 4,
2019, 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/1096/32094. An archive of
the call will be available for replay at the same URL,
https://www.webcaster4.com/Webcast/Page/1096/32094, 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 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 includes statements
regarding the intent to hold a Type-C meeting with the FDA
during the fourth quarter to solidify the clinical protocol
parameters for the SYN-004 program, the anticipated
filing of an IND for SYN-020 during in the first quarter of 2020;
enrollment for the Phase 1b/2a
clinical trial of SYN-004 initiating during the first
quarter of 2020, contingent upon agreement with the FDA and
approval of the clinical study protocol by the Washington University School of Medicine's
Institutional Review Board (IRB); the study design of the Phase
1b/2a clinical trial of SYN-004,
a data readout for the Phase 2b
investigator-sponsored clinical study of SYN-010 for the treatment
of IBS-C is anticipated in 1H 2020; the data readout further
fortifying the clinical data set for SYN -010 and enabling
regulatory discussions to potentially simplify future registration.
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, the
ability of Synthetic Biologics' product candidates to demonstrate
safety and effectiveness, as well as results that are consistent
with prior results, a failure to receive the necessary
regulatory approvals for commercialization of Synthetic Biologics'
therapeutics, including approval of proposed trial designs, 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, a failure to file INDs when anticipated, 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, Synthetic
Biologics' ability to achieve acceptance of its product candidates
in the marketplace and the successful development, marketing or
sale of Synthetic Biologics' products by competitors that render
Synthetic Biologics' products obsolete or non-competitive,
Synthetic Biologics' ability to continue to comply with the
continued listing requirements of the NYSE American, the continued
maintenance and growth of Synthetic Biologics' patent estate,
Synthetic Biologics becoming and remaining profitable, Synthetic
Biologics' ability to obtain or maintain the capital or grants
necessary to fund its research and development activities, a loss
of any of Synthetic Biologics' key scientists or management
personnel and other factors described in Synthetic Biologics' Form
10-K and 10-K/A for the year ended December
31, 2018 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
|
|
|
September 30,
2019
|
|
December
31,
2018
|
Assets
|
|
|
|
Cash and
cash equivalents
|
$
18,650
|
|
$
28,918
|
Prepaid
expenses and other current assets
|
1,193
|
|
593
|
Property
and equipment, net
|
425
|
|
607
|
Right of
Use Asset
|
451
|
|
-
|
Deposits
and other assets
|
23
|
|
23
|
Total
Assets
|
$
20,742
|
|
$
30,141
|
Liabilities and
Stockholder's Deficit
|
|
|
|
Total
liabilities
|
$
6,172
|
|
$
3,686
|
Series A
Convertible Preferred Stock
|
12,481
|
|
12,296
|
Total
Stockholder's Equity
|
2,089
|
|
14,159
|
Total Liabilities
and Stockholders' Deficit
|
$
20,742
|
|
$
30,141
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations
|
(In thousands
except share and per share amounts)
|
|
|
For the three
months ended
September
30,
|
|
For the nine
months ended
September
30,
|
|
(Unaudited)
|
|
(Unaudited)
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Operating Costs
and Expenses
|
|
|
|
|
|
|
|
General
and administrative
|
$
1,098
|
|
$
1,474
|
|
$
3,297
|
|
$
4,525
|
Research
and development
|
4,144
|
|
2,846
|
|
9,156
|
|
9,788
|
Total Operating
Costs and Expenses
|
5,242
|
|
4,320
|
|
12,453
|
|
14,313
|
Loss from
Operations
|
(5,242)
|
|
(4,320)
|
|
(12,453)
|
|
(14,313)
|
Other Income
(Expense)
|
|
|
|
|
|
|
|
Change
in fair value of warrant
liability
|
-
|
|
626
|
|
-
|
|
4,064
|
Interest
income
|
92
|
|
5
|
|
217
|
|
20
|
Total Other Income
(Expense), net
|
92
|
|
631
|
|
217
|
|
4,084
|
Net
Loss
|
(5,150)
|
|
(3,689)
|
|
(12,236)
|
|
(10,229)
|
Net Loss
Attributable to Non-controlling Interest
|
(30)
|
|
(9)
|
|
(73)
|
|
(35)
|
Net Loss
Attributable to Synthetic Biologics, Inc. and
Subsidiaries
|
$
(5,120)
|
|
$
(3,680)
|
|
$
(12,164)
|
|
$
(10,194)
|
Series A
Preferred Stock Dividend
|
(63)
|
|
(61)
|
|
(185)
|
|
(181)
|
Series B
Preferred Stock Dividend
|
(70)
|
|
-
|
|
(585)
|
|
-
|
Net Loss
Attributable to Common Stockholders
|
$
(5,253)
|
|
$
(3,741)
|
|
$
(12,934)
|
|
$
(10,375)
|
Net Loss Per Share
– Basic and Dilutive
|
$
(0.31)
|
|
$
(0.93)
|
|
$
(0.79)
|
|
$
(2.73)
|
Weighted average
number of common shares
outstanding - Basic and Diluted
|
16,805,257
|
|
4,028,304
|
|
16,313,326
|
|
3,802,812
|
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SOURCE Synthetic Biologics, Inc.