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Synthetic Biologics, Inc. (SYN) SEC Filing 10-K Annual Report for the fiscal year ending Friday, December 31, 2021

SEC Filings

Synthetic Biologics, Inc.

CIK: 894158 Ticker: SYN

 

Exhibit 99.1

 

 

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 at 4:30 p.m. ET-

 

Rockville, 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:

 

·VCN acquisition: Synthetic Biologics completed the acquisition of privately held VCN Biosciences, developer of a novel oncolytic adenovirus (OV) platform designed for intravenous (IV), intravitreal (IVit) and intratumoral 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.

 

·Pipeline updates: The acquisition of VCN Biosciences transformed Synthetic Biologics’ pipeline with the addition of VCN's lead clinical-stage drug candidate, VCN-01, as well as preclinical stage VCN-11, which incorporates a proprietary albumin binding domain in the virus shell with the potential to extend the effectiveness of the therapy.

 

oIn February of 2022, VCN-01 received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of retinoblastoma; VCN-01 has previously been granted ODD by the EMA for the treatment of pancreatic cancer.

 

oRegulatory agency recognition builds upon the encouraging clinical data generated to date; VCN-01 has been evaluated in 72 patients across four Phase 1 clinical trials, including patients with pancreatic cancer, head and neck squamous cell carcinoma, colorectal cancer, and retinoblastoma.

 

oEnrollment progressed in the Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease; and topline data for this cohort are expected in H1 2022.

 

oCompleted dosing and follow-up in a Phase 1, placebo-controlled, multiple ascending dose study of SYN-020 in healthy volunteers; SYN-020 was very well tolerated at all doses and patient samples are undergoing pharmacokinetic and pharmacodynamic analyses.

 

Anticipated Milestones:

 

VCN-01

 

·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 (H2 2022).

 


The following information was filed by Synthetic Biologics, Inc. (SYN) on Wednesday, March 16, 2022 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Synthetic Biologics, Inc.'s 10-K Annual Report:

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Document And Entity Information
Consolidated Balance Sheets
Consolidated Balance Sheets (Parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Operations
Consolidated Statements Of Stockholders (Deficit) Equity
Income Taxes
Income Taxes (Details)
Income Taxes (Tables)
Income Taxes - Additional Information (Details)
Income Taxes - Deferred Tax Assets (Details)
License, Collaborative And Employment Agreements And Commitments
License, Collaborative And Employment Agreements And Commitments (Tables)
License, Collaborative And Employment Agreements And Commitments - Additional Information (Details)
License, Collaborative And Employment Agreements And Commitments - Maturity Analysis Of Operating Leases (Details)
Non-Controlling Interest
Non-Controlling Interest (Details)
Organization, Nature Of Operations And Basis Of Presentation
Organization, Nature Of Operations And Basis Of Presentation (Details)
Selected Balance Sheet Information
Selected Balance Sheet Information (Tables)
Selected Balance Sheet Information - Schedule Of Accrued Employee Benefits (Details)
Selected Balance Sheet Information - Schedule Of Accrued Expenses (Details)
Selected Balance Sheet Information - Schedule Of Prepaid Expenses And Other Current Assets (Details)
Selected Balance Sheet Information - Schedule Of Property And Equipment (Details)
Stock-Based Compensation And Warrants
Stock-Based Compensation And Warrants (Tables)
Stock-Based Compensation And Warrants - (Details)
Stock-Based Compensation And Warrants - Options Outstanding And Exercisable (Details)
Stock-Based Compensation And Warrants - Stock Incentive Plan And Other Information (Details)
Stock-Based Compensation And Warrants - Stock Warrants (Details)
Stock-Based Compensation And Warrants - Summary Of All Outstanding And Exercisable Warrants (Details)
Stock-Based Compensation And Warrants - Summary Of All Warrant Activity (Details)
Stock-Based Compensation And Warrants - Summary Of Stock Option Activity (Details)
Stockholders' Equity
Stockholders' Equity (Details)
Subsequent Events
Subsequent Events (Details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies (Tables)
Summary Of Significant Accounting Policies - Additional Information (Details)
Summary Of Significant Accounting Policies - Property And Equipment (Details)
Ticker: SYN
CIK: 894158
Form Type: 10-K Annual Report
Accession Number: 0001410578-22-000405
Submitted to the SEC: Wed Mar 16 2022 4:50:02 PM EST
Accepted by the SEC: Wed Mar 16 2022
Period: Friday, December 31, 2021
Industry: Pharmaceutical Preparations

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