ROCKVILLE, Md., Aug. 6, 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 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 license agreement."
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
Update
- Submitted an Investigational New Drug application (IND) to the
U.S. Food and Drug Administration (FDA) for SYN-020, the Company's
recombinant version of bovine intestinal alkaline phosphatase (IAP)
supporting an initial indication to mitigate the intestinal damage
caused by radiation therapy routinely used to treat pelvic cancers
(Q2 2020)
-
- 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),
- 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;
- Entered into an agreement with Massachusetts General Hospital
(MGH) granting the Company an option for an exclusive license to
intellectual property and technology related to the use of IAP to
maintain GI and microbiome health, diminish systemic inflammation,
and treat age-related diseases (Q2 2020)
-
- Under the terms of the agreement, Synthetic Biologics is
granted exclusive rights to negotiate a worldwide license with MGH
to commercially develop SYN-020 to treat and prevent metabolic and
inflammatory diseases associated with aging,
- If executed, the Company plans to use this license in the
advancement of an expanded clinical development program for
SYN-020;
- Enrollment in the investigator-sponsored Phase 2b clinical trial of SYN-010, intended to treat
IBS-C, has recommenced following a temporary halt in Q1 and Q2 2020
due to the COVID-19 global pandemic; however, the ability to
continue to recruit new patients into this clinical trial remains
at the discretion of CSMC and contingent upon 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 of 2020 and topline data is
anticipated during the first quarter of 2021, subject to the impact
of COVID-19,
- CSMC and Synthetic Biologics are co-funding the study. The
patent rights covering the use of SYN-010 are owned by CSMC and are
exclusively licensed by CSMC to Synthetic Biologics;
- Received written notification from the FDA informing the
Company that the FDA determined the Phase 1b/2a clinical program in adult allogeneic
hematopoietic cell transplant (HCT) recipients may proceed per the
submitted clinical program protocol (Q3 2020)
-
- Due to the unique challenges posed by the global COVID-19
pandemic, Washington University
continues to evaluate non-essential activities, which may have a
direct impact on planned and ongoing clinical trials, including the
SYN-004 (ribaxamase) Phase 1b/2a
clinical program in allogeneic HCT recipients,
- At this time, the Company has determined that postponing the
initiation of the planned Phase 1b/2a
clinical trial in allogeneic HCT recipients until at least the
first quarter of 2021 remains the appropriate course of action due
to continued uncertainty surrounding the ongoing global COVID-19
pandemic;
- On July 30, 2020, the Company
received written communication from NYSE American LLC (the
"Exchange"), the Company's current listing exchange, stating that
in addition to Section 1003(iii), it is now also not in compliance
with both Section 1003(i) and Section 1003(ii) of the NYSE American
Company Guide since it reported a stockholders' deficit of
($4.0) million as of March 31, 2020 and losses from continuing
operations and/or net losses in its five most recent fiscal years
ended December 31, 2019
-
- The Company has previously submitted a plan of compliance which
was accepted by the Exchange addressing how it intends to regain
compliance with the Exchange continued listing standards by
November 25, 2020, the end of the
current compliance plan period,
- The NYSE American notification does not affect the Company's
business operations or the listing of the Company's shares on the
Exchange, and does not represent any change or amendment to the
Company's consolidated financial statements or to its quarterly
reports for the quarter ended March 30,
2020 or to its annual report on Form 10-K for the year ended
December 31, 2019.
Quarter Ended June 30, 2020
Financial Results
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.
Conference Call
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' 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 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.
- Financial Tables Follow -
Synthetic
Biologics, Inc. and Subsidiaries
|
(in thousands,
except share and per share amounts)
|
|
Consolidated
Balance Sheets
|
|
|
|
June 30,
2020
|
|
December 31,
2019
|
Assets
|
|
|
|
Cash and
cash equivalents
|
$
8,059
|
|
$
15,045
|
Prepaid
expenses and other current assets
|
897
|
|
1,381
|
Property
and equipment, net
|
251
|
|
367
|
Right of
Use Asset
|
352
|
|
419
|
Deposits
and other assets
|
23
|
|
23
|
Total
Assets
|
$
9,582
|
|
$
17,235
|
Liabilities and
Stockholder's Deficit
|
|
|
|
Total
liabilities
|
$
3,763
|
|
$
5,748
|
Series A
Convertible Preferred Stock
|
12,669
|
|
12,544
|
Synthetic Biologics,
Inc. and Subsidiaries Equity (Deficit)
|
(3,966)
|
|
1,821
|
Non-controlling
interest
|
(2,884)
|
|
(2,878)
|
Total Liabilities
and Stockholders' Deficit
|
$
9,582
|
|
$
17,235
|
|
|
|
|
Condensed
Consolidated Statements of Operations
|
(In thousands
except share and per share amounts)
|
|
|
For the three
months ended
June 30,
|
|
For the six months
ended
June 30,
|
|
(Unaudited)
|
|
(Unaudited)
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Operating Costs
and Expenses
|
|
|
|
|
|
|
|
General
and administrative
|
$
1,286
|
|
$
1,044
|
|
$
2,679
|
|
$
2,199
|
Research
and development
|
1,603
|
|
2,594
|
|
3,238
|
|
5,012
|
Total Operating
Costs and Expenses
|
2,889
|
|
3,638
|
|
5,917
|
|
7,211
|
Loss from
Operations
|
(2,889)
|
|
(3,638)
|
|
(5,917)
|
|
(7,211)
|
Other
Income
|
|
|
|
|
|
|
|
Interest
income
|
6
|
|
80
|
|
44
|
|
125
|
Total Other
Income, net
|
6
|
|
80
|
|
44
|
|
125
|
Net
Loss
|
(2,883)
|
|
(3,558)
|
|
(5,873)
|
|
(7,086)
|
Net Loss
Attributable to Non-controlling Interest
|
(16)
|
|
(27)
|
|
(42)
|
|
(43)
|
Net Loss
Attributable to Synthetic Biologics, Inc. and
Subsidiaries
|
$
(2,867)
|
|
$
(3,531)
|
|
$
(5,831)
|
|
$
(7,043)
|
Series A
Preferred Dividends
|
(63)
|
|
(61)
|
|
(125)
|
|
(122)
|
Series B
Preferred Dividends
|
(392)
|
|
(117)
|
|
(796)
|
|
(515)
|
Net Loss
Attributable to Common Stockholders
|
$
(3,322)
|
|
$
(3,709)
|
|
$
(6,752)
|
|
$
(7,680)
|
Net Loss Per Share
– Basic and Dilutive
|
$
(0.18)
|
|
$
(0.23)
|
|
$
(0.38)
|
|
$
(0.48)
|
Weighted average
number of common shares outstanding - Basic and
Diluted
|
18,405,884
|
|
16,465,314
|
|
17,748,688
|
|
16,063,283
|
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SOURCE Synthetic Biologics, Inc.