ROCKVILLE, Md., Nov. 10, 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 September 30, 2020.
"During the third quarter, we remained sharply focused on
executing our strategy to advance our portfolio of GI-focused
clinical development programs while continuing to respond 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. "We were pleased to receive formal written
notification from the U.S. Food and Drug Administration ("FDA")
notifying the Company that the proposed Phase 1b/2a clinical study of SYN-004 (ribaxamase) in
adult allogeneic hematopoietic cell transplant ("HCT") recipients
may proceed per our originally submitted clinical program protocol.
Initiation of the planned Phase 1b/2a
clinical trial to be conducted by the Washington School of Medicine
in St. Louis ("Washington University") is anticipated to commence
during the first quarter of 2021, pandemic conditions permitting.
Following the announcement of our expanded collaboration with
Massachusetts General Hospital ("MGH"), we continued to make
significant progress on our SYN-020 intestinal alkaline phosphatase
(IAP) program, including establishing Phase 1-enabling assays and
completion of the manufacturing of drug supply in support of the
planned Phase 1 single ascending dose ("SAD") study in healthy
volunteers. The Phase 1 SAD Study 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."
Mr. Shallcross continued, "During the third quarter, we
announced the results of a planned interim futility analysis of the
investigator-sponsored Phase 2b
clinical study of SYN-010 being conducted by Cedars-Sinai Medical
Center ("CSMC"). Although SYN-010 was well-tolerated, analysis of
the interim data set concluded it was unlikely to meet its primary
objective by the time enrollment was completed. On the basis of
these findings, CSMC agreed to discontinue the trial and intends to
conduct a comprehensive review of the final data set and publish
its findings. While we're disappointed by these results, we're
committed to working with our clinical development partners to
advance SYN-004 and SYN-020. Both of these programs are unrelated
to SYN-010, and therefore, we remain encouraged by the outlook and
potential for these programs to address large, underserved markets.
We continue to closely monitor the crisis caused by the spread of
COVID-19 and look forward to sharing important updates and progress
for our GI-focused clinical programs."
Clinical Development and Operational
Update
- Received written notification from the FDA informing the
Company that the SYN-004 (ribaxamase) Phase 1b/2a clinical program in adult allogeneic
hematopoietic cell transplant ("HCT") recipients may proceed per
the submitted clinical program protocol (Q3 2020)
-
- Initiation of the proposed Phase 1b/2a clinical trial to be conducted by the
Washington University School of
Medicine in St. Louis in adult
allogeneic HCT recipients is anticipated to commence during Q1
2021, pandemic conditions permitting,
- The Phase 1b/2a clinical trial
will comprise a single center, randomized, double-blinded,
placebo-controlled clinical trial of oral SYN-004 (ribaxamase) in
up to 36 evaluable adult 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;
- Received a study-may-proceed letter from the FDA to conduct a
Phase 1 single ascending dose ("SAD") study in healthy volunteers,
designed to evaluate SYN-020 intestinal alkaline phosphatase
("IAP") for safety, tolerability, and pharmacokinetic parameters
(Q3 2020)
-
- 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;
- Announced the results of a planned interim futility analysis of
the investigator-sponsored Phase 2b
clinical study of SYN-010 being conducted by Cedars-Sinai Medical
Center ("CSMC") (Q3 2020)
-
- Based on the review of the interim analysis, it was concluded
that although SYN-010 was well-tolerated, it is unlikely to meet
its primary objective by the time enrollment is completed,
- CSMC has discontinued the trial and will conduct a
comprehensive review of the final data set and publish its
findings,
- On the basis of these results, the Company and CSMC have
mutually decided to terminate the exclusive license agreement and
clinical trial agreements relating to SYN-010. The patent rights
previously licensed to the Company covering the use of SYN-010 will
remain the property of CSMC;
Quarter Ended September 30,
2020 Financial Results
General and administrative expenses increased by 9% to
$1.2 million for the three months
ended September 30, 2020, from
$1.1 million for the three months
ended September 30, 2019. This
increase is primarily due to increased insurance costs and stock
registration fees, offset by a decrease in legal costs. The charge
related to stock-based compensation expense was $67,000 for the three months ended September 30, 2020, compared to $68,000 the three months ended September 30, 2019.
Research and development expenses decreased by 78% to
$0.9 million for the three months
ended September 30, 2020, from
$4.1 million for the three months
ended September 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, as well as the discontinuation of the Phase
2b investigator sponsored clinical
trial of SYN-010. The charge related to stock-based compensation
expense was $15,000 for the three
months ended September 30, 2020,
compared to $23,000 for the three
months ended September 30, 2019.
Other income was $134 for the
three months ended September 30,
2020, compared to other income of $92,000 for the three months ended September 30, 2019. Other income for the three
months ended September 30, 2020 and
2019 is primarily comprised of interest income.
Cash and cash equivalents as of September
30, 2020 totaled $6.0 million,
a decrease of $9.0 million from
December 31, 2019.
Conference Call
Synthetic Biologics will hold a conference call today,
Tuesday, November 10, 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/1096/38296. An archive of
the call will be available for replay at the same URL,
https://www.webcaster4.com/Webcast/Page/1096/38296, for 90 days
after the call.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE American: SYN) is a diversified
clinical-stage company developing 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 Phase 1 single ascending dose study supporting the
clinical development of SYN-020 in multiple indications, initiation
of the proposed Phase 1b/2a clinical trial to be conducted by the
Washington University School of
Medicine in adult allogeneic HCT recipients commencing during Q1
2021. 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 to receive additional funding necessary to
continue operations, a failure of Synthetic Biologics' clinical
trials, and those conducted by investigators, for SYN-004, 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 its 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.
- Financial Tables Follow -
|
Synthetic
Biologics, Inc. and Subsidiaries
|
|
|
(in thousands,
except share and per share amounts)
|
|
|
|
|
Consolidated
Balance Sheets
|
|
|
|
|
|
September 30,
2020
|
|
December 31,
2019
|
Assets
|
|
|
|
Cash and
cash equivalents
|
$
6,005
|
|
$
15,045
|
Prepaid
expenses and other current assets
|
657
|
|
1,381
|
Property
and equipment, net
|
202
|
|
367
|
Right of
Use Asset
|
316
|
|
419
|
Deposits
and other assets
|
23
|
|
23
|
Total
Assets
|
$
7,203
|
|
$
17,235
|
Liabilities and
Stockholder's Deficit
|
|
|
|
Total
liabilities
|
$
3,271
|
|
$
5,748
|
Series A
Convertible Preferred Stock
|
12,733
|
|
12,544
|
Synthetic Biologics,
Inc. and Subsidiaries Equity (Deficit)
|
(6,051)
|
|
1,821
|
Non-controlling
interest
|
(2,750)
|
|
(2,878)
|
Total Liabilities
and Stockholders' Deficit
|
$
7,203
|
|
$
17,235
|
|
|
|
|
|
|
|
|
|
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)
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Operating Costs
and Expenses
|
|
|
|
|
|
|
|
General
and administrative
|
$
1,197
|
|
$
1,098
|
|
$
3,876
|
|
$
3,297
|
Research
and development
|
914
|
|
4,144
|
|
4,152
|
|
9,156
|
Total Operating
Costs and Expenses
|
2,111
|
|
5,242
|
|
8,028
|
|
12,453
|
Loss from
Operations
|
(2,111)
|
|
(5,242)
|
|
(8,028)
|
|
(12,453)
|
Other
Income
|
|
|
|
|
|
|
|
Interest
income
|
-
|
|
92
|
|
44
|
|
217
|
Total Other
Income, net
|
-
|
|
92
|
|
44
|
|
217
|
Net
Loss
|
(2,111)
|
|
(5,150)
|
|
(7,984)
|
|
(12,236)
|
Net Loss
Attributable to Non-controlling Interest
|
(8)
|
|
(30)
|
|
(50)
|
|
(73)
|
Net Loss
Attributable to Synthetic Biologics, Inc. and
Subsidiaries
|
$
(2,103)
|
|
$
(5,120)
|
|
$
(7,934)
|
|
$
(12,163)
|
Series A
Preferred Dividends
|
(64)
|
|
(63)
|
|
(189)
|
|
(185)
|
Series B
Preferred Dividends
|
(519)
|
|
(70)
|
|
(1,315)
|
|
(585)
|
Net Loss
Attributable to Common Stockholders
|
$
(2,686)
|
|
$
(5,253)
|
|
$
(9,438)
|
|
$
(12,933)
|
Net Loss Per Share
– Basic and Dilutive
|
$
(0.14)
|
|
$
(0.31)
|
|
$
(0.52)
|
|
$
(0.79)
|
Weighted average
number of common shares
outstanding - Basic and Diluted
|
19,398,339
|
|
16,805,257
|
|
18,302,585
|
|
16,313,326
|
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SOURCE Synthetic Biologics, Inc.