Recent Updates
Recently added Catalysts
TOVX

Synthetic Biologics Reports First Quarter 2022 Operational Highlights and Financial Results -Encouraging data further supports the development of novel oncolytic adenovirus (OV) platform; Announced a peer-reviewed public

Key Takeaway: Synthetic Biologics Reports First Quarter 2022 Operational Highlights and Financial Results -Encouraging data further supports the development of novel oncolytic adenovirus (OV) platform; Announced a peer-reviewed publication highlighting positive clinical data on VCN-01 and

Full Press Release Details

Synthetic Biologics Reports First Quarter 2022
Operational Highlights and Financial Results
-Encouraging data further supports the development
of novel oncolytic adenovirus (OV) platform; Announced a peer-reviewed publication highlighting positive clinical data on VCN-01 and
an upcoming oral presentation on VCN-11, a novel oncolytic adenovirus designed to evade neutralizing antibodies-
- Reported positive safety data on SYN-020
intestinal alkaline phosphatase from the Phase 1 Multiple Ascending Dose clinical trial-
-Formed Scientific Advisory Board and strengthened
the leadership team to support transformative clinical development strategy and extension into oncology -
-As of March 31, 2022, Synthetic Biologics
reports $56.7 million in cash, which is expected to provide runway through the end of 2023-
-Conference call and webcast to be held today
MD, May 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 March 31, 2022,
and provided a corporate update.
Recent Developments:
Anticipated Milestones:
"We are extremely pleased with the continued
momentum following the transformative VCN acquisition, and our significant corporate advancements that mark a new phase of strategic
growth," said Steven A. Shallcross, Chief Executive Officer of Synthetic Biologics. "This is an important phase of Synthetic
Biologics' evolution, and to support our extension into oncology, we strengthened our leadership team and recently formed a Scientific
Advisory Board of leading experts composed of key opinion leaders. These distinguished leaders have made groundbreaking scientific advances
in their respective fields of oncology, immunology and gene therapy, and we look forward to their counsel as we advance our oncolytic
adenovirus development program to address devastating cancers with high unmet need. We are well positioned to deliver on our sharpened
clinical development strategy and are poised for an exciting year ahead with the anticipation of multiple clinical studies and pivotal
milestones that should continue to drive shareholder value."
Quarter Ended March 31, 2022 Financial
General and administrative expenses increased
to $1.7 million for the for the three months ended March 31, 2022, from $1.4 million for the three months ended March 31, 2021. This
increase of 17% primarily composed of increased consulting and legal costs related to the VCN acquisition, higher insurance costs, audit
fees, and public relations expenses and VCN administrative expenses not included in prior year. The charge related to stock-based compensation
expense was $85,000 for the three months ended March 31, 2022, compared to $82,000 the three months ended March 31, 2021.
Research and development expenses increase to
$2.6 million for the three months ended March 31, 2022, from approximately $1.1 million for the three months ended March 31, 2021. This
increase of 132% is primarily the result of higher manufacturing expense for SYN-020, costs incurred related to our Phase 1a clinical
trial of SYN-020 and the Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients and VCN research expenses related
to VCN-01 not incurred in the prior year. We anticipate research and development expense to increase as we plan for and initiate enrollment
for our phase 2 clinical trial for VCN-01 in PDAC, phase 2/3 clinical trial in retinoblastoma, expand GMP manufacturing activities for
VCN-01 and SYN-020, and continue with supporting our VCN-11 and other preclinical and discovery initiatives. The charge related to stock-based
compensation expense was $28,000 for the three months ended March 31, 2022, compared to $19,000 related to stock-based compensation expense
for the three months ended March 31, 2021.
Other expense was $21,068 for the three months
ended March 31, 2022 compared to other income of $347 for the three months ended March 31, 2021. Other expense is primarily composed
of exchange loss of $22,607, offset by interest income of $1,539. Other income for the three months ended March 31, 2021 is primarily
comprised of interest income.
Cash and cash equivalents totaled $56.7 million
as of March 31, 2022, a decrease of $10.5 million from December 31, 2021.
Synthetic Biologics will host a conference call at 8:30 a.m. ET today
to review first quarter 2022 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: 13729717. 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. The Company's lead candidates are: (1) VCN-01, an oncolytic
adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves
as a significant physical and immunosuppressive barrier to cancer treatment; (2) 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 (3) 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 the potential of VCN-11 to balance safety, the suggestion that treatment with VCN-01 is feasible has an acceptable safety profile,
the SAD and MAD studies supporting the development of SYN-020 in multiple clinical indications, initiation of VCN-01 dosing in
an investigator sponsored study of brain tumors at the University of Leeds (H1 2022) initiation of VCN-01 dosing in combination with
mesothelin-directed CAR-T cells for pancreatic and ovarian cancer 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 (Q4 2022), initiation of a Phase 2/3 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 (H2 2022), planning for the initiation of a Phase 2a study of SYN-020 (H2 2022),
being well positioned to deliver on our sharpened clinical development strategy and being poised for an exciting year ahead with the
anticipation of multiple clinical studies and pivotal milestones that should continue to drive shareholder value 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 VCN-01 dosing in an investigator
sponsored study of brain tumors at the University of Leeds (H1 2022), initiate VCN-01 dosing in combination with mesothelin-directed
CAR-T cells for pancreatic and ovarian cancer in an investigator sponsored study at the University of Pennsylvania (H1 2022), initiate
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 (Q4 2022), initiate a Phase 2/3 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 (H2 2022), the SAD and MAD studies supporting the development of SYN-020 in multiple clinical indications and planning
for the initiation of a Phase 2a study of SYN-020 (H2 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
maintenance and growth of Synthetic Biologics' and VCN's patent estate, the ability to continue to remain well financed, and other factors
Last updated: May 16, 2022