Synthetic Biologics, Inc. (SYN) 10K Annual Reports & 10Q SEC Filings

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.

In 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.

Regulatory 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.

Enrollment 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.

Completed 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 - Expense Highlight
In addition, we expect research and development expenses to increase as we incur program costs for VCN's product candidates.

Legal - Other Highlight
This increase of 28.7% primarily comprised of increased consulting and legal costs related to the VCN acquisition, higher insurance costs, audit fees, and public relations expenses.
M & A - Other Highlight
We believe our cash position of $57.1 million in mid March 2022 is sufficient to fund our operations through at least the end of the fourth quarter of 2023, including continuation of our ongoing Phase 1b/2a clinical study of SYN-004 (ribaxamase) in allogeneic HCT recipients for the prevention of aGVHD, as well as our planned Phase 1 and Phase 2 clinical programs for SYN-020 and to fund our committed obligations under the Purchase Agreement for the VCN Acquisition.
Other - Other Highlight
Our cash and cash equivalents totaled $67.3 million as of December 31, 2021, an increase of $61.1 million from December 31, 2020.
Financial - Expense Highlight
Years Ended December 31, 2021 and 2020 General and Administrative Expenses 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.
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Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Material Contracts, Statements, Certifications & more

Synthetic Biologics, Inc. provided additional information to their SEC Filing as exhibits

Exhibit 4.4: Instruments Defining The Rights Of Security Holders, Including Indentures

Exhibit 10.4: Material Contract

Exhibit 10.32: Material Contract

Exhibit 10.33: Material Contract

Exhibit 10.34: Material Contract

Exhibit 10.35: Material Contract

Exhibit 21.1: Subsidaries Of The Registrant

Exhibit 23.1: Consents Of Experts And Counsel

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

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

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