Full Press Release Details
Synthetic Biologics Reports 2021 Year End Operational
Highlights and Financial Results
-Completed acquisition of VCN Biosciences, expanding
pipeline into oncology-
-VCN-01 received Orphan Drug Designation for
retinoblastoma from the U.S. FDA-
-As of December 31, 2021, Synthetic Biologics
reports $67.3 million in cash, which is expected to provide runway through the end of 2023-
-Conference call and webcast to be held today
MD, March 16, 2022 - Synthetic Biologics, Inc. (NYSE American: SYN), a
diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, today
reported financial results for the year ended December 31, 2021, and provided a corporate update.
Recent Developments:
Anticipated Milestones:
"2021 was a monumental year for the Company,
setting the stage for continued progress and a number of important upcoming milestones in 2022," said Steven A. Shallcross, Chief
Executive Officer of Synthetic Biologics. "The recent acquisition of VCN Biosciences positions us at the forefront of oncolytic
virus development. VCN's systemically administered, selectively replicating adenoviruses are designed to break down the tumor stroma,
which hides the tumor from the patient's immune system. In turn, this improves the anti-tumor effect of the oncolytic virus, as
well as chemotherapies and immuno-oncology products."
Mr. Shallcross continued, "We are poised
for another exciting year ahead as we anticipate the initiation of multiple international studies, including a Phase 2 clinical trial
of intravenous VCN-01 in combination with standard-of-care chemotherapy as a first line therapy in newly-diagnosed metastatic PDAC patients,
as well as a Phase 2/3 pivotal trial of intravitreal VCN-01 as either an adjunct to chemotherapy or a potential rescue therapy in pediatric
patients with advanced retinoblastoma. We do not plan any clinical activities in Eastern Europe; however, we recognize that the war in
the Ukraine may have follow-on effects globally that could adversely impact the cost and conduct of our international clinical trials.
We will seek to mitigate this impact where possible. In parallel with our development of VCN-01, we continue to advance the clinical development
of both SYN-004 and SYN-020 and look forward to providing further updates on key upcoming milestones. We remain well-capitalized through
the end of 2023 and highly encouraged by the potential for each of our clinical programs."
Year Ended December 31, 2021 Financial Results
General and administrative expenses increased
to $6.5 million for the year ended December 31, 2021, from $5.0 million for the year ended December 31, 2020. This increase of 28.7% is
primarily composed of increased consulting and legal costs related to the VCN acquisition, higher insurance costs, audit fees, and public
relations expenses. The charge relating to stock-based compensation expense was $0.3 million for the year ended December 31, 2021, compared
to $0.3 million for the year ended December 31, 2020.
Research and development expenses increased to
$7.8 million for the year ended December 31, 2021, from $5.1 million for the year ended December 31, 2020. This increase of 53% is primarily
the result of increased clinical trial expenses as we continued dosing patients in the Phase 1b/2a clinical trial of SYN-004, the dosing
of healthy volunteers in the SAD and MAD Phase 1 clinical trials for SYN-020, and by higher indirect program costs for the year ended
December 31, 2021, including an increase in manufacturing costs for SYN-020. We anticipate research and development expense to increase
as our ongoing clinical trials continue to enroll patients and new patients are enrolled in the VCN-01 clinical trials. Research and development
expenses also included a charge relating to non-cash stock-based compensation expense of $76,000 for the year ended December 31, 2021,
compared to $66,000 for the year ended December 31, 2020.
Other income was $6,000 for the year ended December
31, 2021, compared to other income of $44,000 for the year ended December 31, 2020. Other income for the year ended December 31, 2021
and 2020 is primarily composed of interest income from investments.
Cash and cash equivalents totaled $67.3 million
as of December 31, 2021, an increase of $61.1 million from December 31, 2020.
For further details on Synthetic Biologics'
financial results refer to the Company's Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities
and Exchange Commission.
Synthetic Biologics will host a conference call at 4:30 p.m. ET today
to review year end 2021 operational highlights and financial results. Individuals may participate in the live call via telephone by dialing
(877) 451-6152 (domestic) or (201) 389-0879 (international) and using the conference ID: 13727535. Participants are asked to dial in
15 minutes before the start of the call to register. Investors and the public can access the live and archived webcast of this call via
the "News & Media" section of the company's website, https://www.syntheticbiologics.com, under "Events"
or by clicking here, 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 treat diseases in areas of high unmet need. The
Company recently consummated the acquisition of VCN Biosciences, S.L. (VCN), which is developing a new oncolytic adenovirus (OV)
platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of
co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient's immune
system. In addition, the Company's lead candidates are: (1) SYN-004 (ribaxamase) which is designed to degrade certain commonly used
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.
Forward-Looking Statements
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 initiation of VCN-01 dosing in an investigator sponsored study at the
University of Leeds (H1 2022); initiation of VCN-01 dosing in combination with mesothelin-directed CAR-T cells in an investigator
sponsored study at the University of Pennsylvania (H1 2022); initiation of a Phase 2 study of VCN-01 in combination with
standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy in newly diagnosed metastatic PDAC patients (H2
2022); initiation of a Phase 2/3 pivotal trial of VCN-01 as either an adjunct to chemotherapy or a potential rescue therapy in
pediatric patients with advanced retinoblastoma (early 2023); data read out from the first cohort of the SYN-004 study in allo-HCT
patients (H1 2022); top-line data from the multiple ascending dose study of SYN-020 in healthy volunteers (H1 2022); initiation of a
Phase 2a study of SYN-020 (H2 2022), and providing further updates on key upcoming milestones, remaining well-capitalized
through the end of 2023 and the potential for each of our clinical programs. 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, whether the combined business of Synthetic Biologics and VCN
will be successful; Synthetic Biologics' and VCN's product candidates demonstrating safety and effectiveness, as well as results
that are consistent with prior results; the ability to initiate clinical trials (including initiation of VCN-01 dosing in an
investigator sponsored study at the University of Leeds (H1 2022), initiation of VCN-01 dosing in combination with
mesothelin-directed CAR-T cells in an investigator sponsored study at the University of Pennsylvania (H1 2022), the planned Phase 2
trial of VCN-01 in combination with standard-of-care gemcitabine/nab-paclitaxel as a first line therapy in newly diagnosed
metastatic PDAC patients (H2 2022), and a Phase 2/3 pivotal trial as either an adjunct to chemotherapy or a potential rescue therapy
in in pediatric patients with advanced retinoblastoma (early 2023)); the data read out from the first cohort of the SYN-004 study
(H1 2022); the ability to complete clinical trials on time and achieve the desired results and benefits; continuing clinical trial
enrollment as expected; the ability to obtain regulatory approval for commercialization of product candidates or to comply with
ongoing regulatory requirements, regulatory limitations relating to Synthetic Biologics' and VCN's ability to promote or
commercialize their product candidates for the specific indications; acceptance of product candidates in the marketplace and the
successful development, marketing or sale of Synthetic Biologics' and VCN's products; developments by competitors that render such
products obsolete or non-competitive; Synthetic Biologics' and VCN's ability to maintain license agreements;, the continued