Forte Biosciences, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Forte Biosciences, Inc. has filed its 2023 10-K report detailing its financial performance and business operations.</b>

AI Summary

Forte Biosciences, Inc. (FBRX) filed a Annual Report (10-K) with the SEC on March 18, 2024. Forte Biosciences, Inc. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023. The filing includes financial data and disclosures for the period. The company's principal executive offices are located in Dallas, TX. Forte Biosciences, Inc. was formerly known as Tocagen Inc. The SIC code for the company is 2834 (Pharmaceutical Preparations).

Why It Matters

For investors and stakeholders tracking Forte Biosciences, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Forte Biosciences' financial health and strategic direction for investors and stakeholders. As a pharmaceutical preparations company, the disclosures in this report are crucial for understanding its regulatory compliance and market positioning.

Risk Assessment

Risk Level: low — Forte Biosciences, Inc. shows low risk based on this filing. The filing is a standard annual report (10-K) and does not contain immediate, significant negative news or events, indicating a routine disclosure cycle.

Analyst Insight

Monitor future filings for updates on Forte Biosciences' clinical trials, regulatory approvals, and financial performance in the pharmaceutical sector.

Key Numbers

• 2023-12-31 — Fiscal Year End (Period of report)
• 2024-03-18 — Filing Date (Date of filing)
• 2834 — SIC Code (Standard Industrial Classification)

Key Players & Entities

• Forte Biosciences, Inc. (company) — Filer name
• FBRX (company) — Ticker symbol
• Tocagen Inc. (company) — Former company name
• Dallas, TX (location) — Business and mailing address city and state
• 2834 (other) — Standard Industrial Classification code
• 2023-12-31 (date) — Fiscal year end
• 2024-03-18 (date) — Filing date

FAQ

Industry Context

Forte Biosciences operates within the Pharmaceutical Preparations industry, which is characterized by extensive research and development, regulatory hurdles, and market competition.

Regulatory Implications

As a pharmaceutical company, Forte Biosciences is subject to stringent regulations from bodies like the FDA, impacting its product development, manufacturing, and marketing activities.

What Investors Should Do

1. Review the full 10-K filing for detailed financial statements and management's discussion and analysis.
2. Analyze any disclosed risk factors related to clinical trials, regulatory approvals, and market adoption of its products.
3. Track future SEC filings for updates on the company's progress and any material events.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-03-18: Filing Date — Date the 10-K report was officially submitted to the SEC.

Year-Over-Year Comparison

This is the company's 2023 annual report (10-K), following previous filings which would have included quarterly reports (10-Q) and potentially other material event disclosures.

Key Financial Figures

• $1.2 billion — treatment market size was estimated at $1.2 billion in 2018 and is projected to reach $1.9
• $1.9 billion — llion in 2018 and is projected to reach $1.9 billion by 2026 (Fortune Business Insights).
• $2.7 billion — alopecia treatment market was valued at $2.7 billion in 2018, and is projected to reach $3.9
• $3.9 billion — lion in 2018, and is projected to reach $3.9 billion by 2026, resulting in a CAGR of 4.6% fr
• $37.1 million — d Mkt Research). We had approximately $37.1 million in cash and cash equivalents as of Dece
• $1.006 — y's common stock at a purchase price of $1.006 per Share, and 9,689,293 pre-funded war
• $1.005 — of common stock at a purchase price of $1.005 per pre-funded warrant ("Private Placem
• $0.001 — nded warrants have an exercise price of $0.001 per share of common stock, are immediat
• $25 million — he Private Placement were approximately $25 million and the Company incurred $272 thousand
• $272 thousand — ly $25 million and the Company incurred $272 thousand in issuance costs. Certain executive of
• $1.16 million — ate Placement, purchasing approximately $1.16 million of shares of common stock at a purchase
• $1.01 — of common stock at a purchase price of $1.01 per share. In connection with the Priva
• $300 million — 2021 which allowed Forte to raise up to $300 million in additional capital. On March 31, 202
• $25.0 million — ck up to an aggregate offering price of $25.0 million during the term of the ATM Facility. On
• $7.0 million — he ATM Facility covering sales of up to $7.0 million of shares of common stock. On August 12

Filing Documents

• fbrx-20231231.htm (10-K) — 1981KB
• fbrx-ex10_16.htm (EX-10.16) — 416KB
• fbrx-ex10_17.htm (EX-10.17) — 20KB
• fbrx-ex21_1.htm (EX-21.1) — 8KB
• fbrx-ex23_1.htm (EX-23.1) — 5KB
• fbrx-ex23_2.htm (EX-23.2) — 4KB
• fbrx-ex31_1.htm (EX-31.1) — 15KB
• fbrx-ex31_2.htm (EX-31.2) — 15KB
• fbrx-ex32_1.htm (EX-32.1) — 8KB
• fbrx-ex32_2.htm (EX-32.2) — 8KB
• fbrx-ex97_1.htm (EX-97.1) — 49KB
• 0000950170-24-032843.txt (&nbsp;) — 8053KB
• fbrx-20231231.xsd (EX-101.SCH) — 1035KB
• fbrx-20231231_htm.xml (XML) — 1168KB

Business

Business 3 Item 1A.

Risk Factors

Risk Factors 13 Item 1B. Unresolved Staff Comments 52 Item 1C. Cybersecurity 52 Item 2.

Properties

Properties 53 Item 3.

Legal Proceedings

Legal Proceedings 53 Item 4. Mine Safety Disclosures 53 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 54 Item 6. Reserved 54 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 55 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 61 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 61 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosur e 61 Item 9A.

Controls and Procedures

Controls and Procedures 61 Item 9B. Other Information 62 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 62 PART III Item 10. Directors, Executive Officers and Corporate Governance 63 Item 11.

Executive Compensation

Executive Compensation 63 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 63 Item 13. Certain Relationships and Related Transactions, and Director Independence 63 Item 14. Principal Accounting Fees and Services 63 PART IV Item 15. Exhibits, Financial Statement Schedules 64 1 PART I

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K 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"). These forward-looking statements are based on current expectations and beliefs and involve numerous risks and uncertainties that could cause actual results to differ materially from expectations. These forward-looking statements should not be relied upon as predictions of future events as it cannot be assured that the events or circumstances reflected in these statements will be achieved or will occur. You can identify forward-looking statements by the use of forward-looking terminology including "anticipates," "believes," "could," "seeks," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "pro forma," "should," "will," "would," or the negative of these words and phrases or other variations of these words and phrases or comparable terminology. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. For example, forward-looking statements include, but are not limited to statements about: any statements of the plans, strategies and objectives of management for future operations; any statements concerning proposed new products, services or developments; any statements regarding any business disruption or potential impact to our business due to COVID-19; any statements regarding future economic conditions or performance; any statements regarding future regulatory approvals; our expectations regarding the timing of product launches, as well as product features and specifications, including target indications for FB-102; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; the timing, scop

Business

Item 1. Business Overview Forte Biosciences, Inc. and its subsidiaries ( www.fortebiorx.com ) ("Forte", "we", "our") is a clinical-stage biopharmaceutical company whose lead product candidate, FB-102, is currently in a Phase 1 trial. FB-102 is a proprietary molecule with potentially broad autoimmune and autoimmune-related applications including in such indications as graft-versus-host disease ("GvHD"), vitiligo and alopecia areata ("AA"). The Company's FB-102 program aims to address key pathways implicated in these indications with a CD122 antagonist. CD122 is a subunit of IL-2/IL-15 receptors which are key regulators of NK cells and T cell subsets. The primary objective of the Phase 1 trial is to assess the safety, tolerability and pharmacokinetics of single and multiple ascending doses of FB-102 under intravenous and subcutaneous administration. Three cohorts of single ascending doses were successfully completed in March 2024. Cohorts of multiple ascending doses have commenced. GvHD is a complication that may occur after an allogeneic transplant and is where donor's T-cells attack the patient's healthy cells . There are 2 main types of GvHD – acute GvHD and chronic GvHD. The severity of symptoms range from mild to fatal. US prevalence of acute GvHD is estimated at approximately 5,000 cases and occurs in up to 50% of allogeneic stem cell transplant recipients. Onset of acute GvHD typically occurs within 3 months of transplant. Symptoms occur in the skin (rash), GI tract (vomiting, diarrhea) and liver (jaundice). US prevalence of chronic GvHD is estimated at approximately 14,000 cases and occurs in up to 40% of recipients. In addition to symptoms in the skin, GI tract and liver, chronic GvHD may also manifest itself in the lungs, mucosal surfaces (eyes, mouth, GU tract), muscle and joints (connective tissue). Vitiligo is a disease of the skin mediated primarily by NK and CD8+ T cells that attack melanocytes leading to patchy depigmentation of the skin.

View Full Filing

View this 10-K filing on SEC EDGAR