Theriva Biologics Files 2023 Annual Report on Form 10-K

Ticker: TOVX · Form: 10-K · Filed: Mar 25, 2024 · CIK: 894158

Theriva Biologics, Inc. 10-K Filing Summary
FieldDetail
CompanyTheriva Biologics, Inc. (TOVX)
Form Type10-K
Filed DateMar 25, 2024
Risk Level
Pages15
Reading Time18 min
Key Dollar Amounts$1
Sentimentneutral

Sentiment: neutral

Topics: 10-K, Annual Report, Theriva Biologics, Financials, SEC Filing

TL;DR

<b>Theriva Biologics, Inc. has filed its annual report detailing its 2023 financial performance and corporate history.</b>

AI Summary

Theriva Biologics, Inc. (TOVX) filed a Annual Report (10-K) with the SEC on March 25, 2024. Theriva Biologics, Inc. (formerly Synthetic Biologics, Inc.) filed its 2023 10-K report on March 25, 2024. The company was formerly known as Adeona Pharmaceuticals, Inc. and Pipex Pharmaceuticals, Inc. The filing covers the fiscal year ending December 31, 2023. The company's principal executive offices are located in Rockville, MD. Theriva Biologics operates in the Pharmaceutical Preparations industry (SIC code 2834).

Why It Matters

For investors and stakeholders tracking Theriva Biologics, Inc., this filing contains several important signals. The 10-K filing provides a comprehensive overview of Theriva Biologics' financial health, operational activities, and strategic direction for the fiscal year 2023. Understanding the company's historical name changes and its current operational base is crucial for assessing its evolution and market positioning.

Risk Assessment

Risk Level: — Theriva Biologics, Inc. shows moderate risk based on this filing. The filing is a standard annual report (10-K) and does not contain immediate red flags or urgent disclosures.

Analyst Insight

Review the detailed financial statements and risk factors within the 10-K to assess Theriva Biologics' current financial standing and future prospects.

Key Numbers

  • 2023-12-31 — Fiscal Year End (Period covered by the 10-K report)
  • 2024-03-25 — Filing Date (Date the 10-K was filed)
  • 2834 — SIC Code (Industry classification for Pharmaceutical Preparations)

Key Players & Entities

  • Theriva Biologics, Inc. (company) — Filer
  • Synthetic Biologics, Inc. (company) — Former company name
  • Adeona Pharmaceuticals, Inc. (company) — Former company name
  • Pipex Pharmaceuticals, Inc. (company) — Former company name
  • Rockville, MD (location) — Business address
  • Steven A. Shallcross (person) — Mentioned in relation to a date

FAQ

When did Theriva Biologics, Inc. file this 10-K?

Theriva Biologics, Inc. filed this Annual Report (10-K) with the SEC on March 25, 2024.

What is a 10-K filing?

A 10-K is a comprehensive annual financial report required by the SEC, covering audited financials, business operations, risk factors, and management discussion. This particular 10-K was filed by Theriva Biologics, Inc. (TOVX).

Where can I read the original 10-K filing from Theriva Biologics, Inc.?

You can access the original filing directly on the SEC's EDGAR system. The filing is publicly available and includes all exhibits and attachments submitted by Theriva Biologics, Inc..

What are the key takeaways from Theriva Biologics, Inc.'s 10-K?

Theriva Biologics, Inc. filed this 10-K on March 25, 2024. Key takeaways: Theriva Biologics, Inc. (formerly Synthetic Biologics, Inc.) filed its 2023 10-K report on March 25, 2024.. The company was formerly known as Adeona Pharmaceuticals, Inc. and Pipex Pharmaceuticals, Inc.. The filing covers the fiscal year ending December 31, 2023..

Is Theriva Biologics, Inc. a risky investment based on this filing?

Based on this 10-K, Theriva Biologics, Inc. presents a moderate-risk profile. The filing is a standard annual report (10-K) and does not contain immediate red flags or urgent disclosures.

What should investors do after reading Theriva Biologics, Inc.'s 10-K?

Review the detailed financial statements and risk factors within the 10-K to assess Theriva Biologics' current financial standing and future prospects. The overall sentiment from this filing is neutral.

How does Theriva Biologics, Inc. compare to its industry peers?

Theriva Biologics operates within the pharmaceutical preparations sector, focusing on the development and commercialization of therapeutic products.

Are there regulatory concerns for Theriva Biologics, Inc.?

The filing is subject to SEC regulations governing public company disclosures, including the accuracy and completeness of financial reporting.

Industry Context

Theriva Biologics operates within the pharmaceutical preparations sector, focusing on the development and commercialization of therapeutic products.

Regulatory Implications

The filing is subject to SEC regulations governing public company disclosures, including the accuracy and completeness of financial reporting.

What Investors Should Do

  1. Analyze the financial statements for revenue, net income, and cash flow.
  2. Review the risk factors section for potential challenges and uncertainties.
  3. Examine management's discussion and analysis for strategic insights.

Key Dates

  • 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K
  • 2024-03-25: Filing Date — Date the 10-K was officially submitted to the SEC

Glossary

10-K
An annual report required by the U.S. Securities and Exchange Commission (SEC), which gives a comprehensive summary of a company's financial performance. (Provides detailed financial and operational information about Theriva Biologics for the fiscal year 2023.)

Year-Over-Year Comparison

This is the initial 10-K filing for Theriva Biologics under its current name, following previous filings under different corporate identities.

Filing Stats: 4,443 words · 18 min read · ~15 pages · Grade level 14.7 · Accepted 2024-03-25 16:20:55

Key Financial Figures

  • $1 — oximately $ 16,791,123 million based on $1.00, the closing price of the registrant

Filing Documents

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 31 Item 1B. Unresolved Staff Comments 59 Item 1C. Cybersecurity 59 Item 2.

Properties

Properties 60 Item 3.

Legal Proceedings

Legal Proceedings 60 Item 4. Mine Safety Disclosures 60 PART II. 60 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 60 Item 6. [Reserved] 61 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 61 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 68 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 69 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 108 Item 9A.

Controls and Procedures

Controls and Procedures 108 Item 9B. Other Information 109 I tem 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 109 PART III. 110 Item 10. Directors, Executive Officers and Corporate Governance 110 Item 11.

Executive Compensation

Executive Compensation 113 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 123 Item 13. Certain Relationships and Related Transactions, and Director Independence 124 Item 14. Principal Accountant Fees and Services 125 PART IV. 126 Item 15. Exhibits and Financial Statement Schedules 126 Item 16. Form 10-K Summary 132 2 Table of Contents PART I Special Note Regarding Forward-Looking Statements This Annual Report on Form 10-K (this "Annual Report") contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), that involve substantial risks and uncertainties. The forward-looking statements are contained principally in Part I, Item 1. "Business," Part I, Item 1A. "Risk Factors," and Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations," but are also contained elsewhere in this Annual Report. In some cases you can identify forward-looking statements by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based on our current beliefs, expectations, and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and generally beyond our control, that could cause actual results to differ materially from those expressed, projected or implied in or by the forward-looking statements. You should refer to Item 1A. "Risk Factors" section of this Annual Report for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Annual Report will prove to be a

Business

Item 1. Business . Overview We are a diversified clinical-stage company developing therapeutics designed ot treat cancer and related diseases in areas of high unmet need. As a result of the acquisition in March 2022 of Theriva Biologics, S.L. ("VCN", formerly named VCN Biosciences, S.L.), described in more detail below (the "Acquisition"), we began transitioning our strategic focus to oncology, which is now our primary focus, through the development of VCN's new oncolytic adenovirus platform designed for intravenous and intravitreal delivery to trigger tumor cell death, to improve access of co-administered cancer therapies to the tumor, and to promote a robust and sustained anti-tumor response by the patient's immune system. Our lead product candidate, VCN-01, a clinical stage oncolytic human adenovirus that is modified to express an enzyme, PH20 hyaluronidase, is currently being administered in a Phase 2 clinical study for the treatment of pancreatic cancer, a Phase 1 clinical study for the treatment of retinalblastoma, a Phase 1 clinical study for the treatment of head and neck squamous cell carcinoma and a Phase 1 clinical study for the treatment of solid tumors. Prior to the Acquisition, our focus was on developing therapeutics designed to treat gastrointestinal (GI) diseases which included our clinical development candidates: (1) SYN-004 (ribaxamase) which is designed to degrade certain commonly used intravenous (IV) beta-lactam antibiotics within the GI tract to prevent microbiome damage, thereby preventing overgrowth and infection by pathogenic organisms such Clostridioides difficile infection (CDI) and vancomycin resistant Enterococci (VRE), and reducing the incidence and severity of 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 s

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