Forte Biosciences(FBRX) - 2020 Q4 - Annual Report

Part I Business Forte Biosciences is a clinical-stage biopharmaceutical company developing its lead product, FB-401, for inflammatory skin diseases like atopic dermatitis - The company's lead product candidate is FB-401, a topically applied, live biotherapeutic for treating inflammatory skin diseases like atopic dermatitis (AD), with a focus on pediatric patients[11] - In June 2020, Forte completed a reverse merger with Tocagen, Inc, becoming a publicly traded company on the Nasdaq under the symbol FBRX[12] - A multi-center, double-blinded, placebo-controlled Phase 2 clinical trial of FB-401 was initiated in September 2020, with results expected in mid-2021[13][40] - The company's intellectual property includes 7 issued U.S. patents covering formulations, manufacturing, and methods of use, which are expected to expire in April 2037[49][51] Risk Factors The company faces risks from its history of net losses, dependence on a single product candidate, reliance on third parties, and intellectual property challenges - The company has a history of net losses, reporting a loss of $46.5 million in 2020, and anticipates continued losses, requiring substantial additional capital[126][131] - Forte's prospects are highly dependent on its single product candidate, FB-401, which involves a lengthy, expensive, and uncertain development process[141][154][166] - The company relies on third parties for conducting clinical trials (CROs) and manufacturing clinical supplies (CMOs), and failure by these parties could halt development[340][346] - Forte's success depends on its ability to obtain and maintain patent protection and faces risks of its patents being challenged, invalidated, or circumvented[280][286] - The company faces significant competition from major pharmaceutical companies with greater resources, such as Regeneron/Sanofi (Dupixent) and Pfizer (Eucrisa)[182][183] Unresolved Staff Comments The company reports no unresolved staff comments - None[390] Properties The company leases adequate office and lab space in Torrance, California, under a cancellable agreement - The company leases office and laboratory space in Torrance, California, on a monthly basis with a 30-day cancellation notice[391] Legal Proceedings The company reports no legal proceedings - None[392] Mine Safety Disclosures This item is not applicable to the company - Not applicable[393] Part II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities The company's stock trades on Nasdaq as "FBRX", and no dividends or stock repurchases have occurred - Common stock began trading on the Nasdaq Capital Market under the ticker "FBRX" on June 16, 2020[397] - The company has never declared or paid cash dividends and does not intend to in the foreseeable future[399] - There were no repurchases of common stock in 2020[402] Selected Financial Data As a smaller reporting company, this information is not required - Not required as the company is a "smaller reporting company"[404] Management's Discussion and Analysis of Financial Condition and Results of Operations The 2020 net loss increased to $46.5 million due to a merger charge and higher expenses, though cash is sufficient for the next 12 months Results of Operations (in thousands) | | Year Ended Dec 31, 2020 | Year Ended Dec 31, 2019 | Change | |:---|:---:|:---:|:---:| | Research and development | $10,004 | $2,684 | $7,320 | | General and administrative | $4,221 | $1,380 | $2,841 | | In-process R&D assets acquired | $32,057 | $— | $32,057 | | Net Loss | ($46,487) | ($4,069) | ($42,418) | - The increase in R&D expenses by $7.3 million was primarily due to a $5.4 million increase in manufacturing, clinical, and regulatory costs for the FB-401 program[440] - The increase in G&A expenses by $2.8 million was mainly due to a $1.2 million increase in legal/professional fees and a $1.0 million increase in payroll-related costs[441] - A one-time charge of $32.1 million for acquired in-process research and development (IPR&D) assets was recognized in connection with the Tocagen merger[442] - As of December 31, 2020, the company had cash and cash equivalents of $58.8 million and believes this is sufficient to fund operations for at least 12 months[449][444] Summary of Cash Flows (in thousands) | | Year Ended Dec 31, 2020 | Year Ended Dec 31, 2019 | |:---|:---:|:---:| | Net cash used in operating activities | ($18,423) | ($2,771) | | Net cash provided by (used in) investing activities | $3,582 | ($162) | | Net cash provided by financing activities | $66,667 | $4,856 | Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, this information is not required - Not required as the company is a "smaller reporting company"[466] Financial Statements and Supplementary Data This section indicates the required financial statements are included starting on page F-1 of the report - The financial statements and supplementary data are included at the end of the Annual Report on Form 10-K, beginning on page F-1[467] Changes in and Disagreements with Accountants on Accounting and Financial Disclosure The company reports no disagreements with its accountants - None[468] Controls and Procedures Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2020 - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2020[470] - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2020, based on the COSO framework[472] Other Information The company reports no other information - None[477] Part III Directors, Executive Officers, Corporate Governance, Executive Compensation, Security Ownership, and Related Matters Information for Items 10-14 is incorporated by reference from the company's 2021 proxy statement - Information for Items 10, 11, 12, 13, and 14 is incorporated by reference from the company's Definitive Proxy Statement[480][481][482][483][484] Part IV Exhibits, Financial Statement Schedules This section lists documents filed with the report, noting financial statements begin on page F-1 and schedules are omitted - The financial statements are filed as part of the report, beginning on page F-1[487] - Financial statement schedules are omitted because they are not applicable or the information is included in the financial statements or notes[488] Form 10-K Summary The company has elected not to include a Form 10-K summary - The Company has elected to not include a summary[503] Financial Statements Report of Independent Registered Public Accounting Firm The auditor issued an unqualified opinion on the 2020 and 2019 financial statements, finding them fairly presented in conformity with U.S. GAAP - The auditor, Mayer Hoffman McCann P.C, issued an unqualified (clean) opinion on the consolidated financial statements for fiscal years 2020 and 2019[515] Consolidated Financial Statements The company's financial position changed significantly in 2020 due to a reverse merger and financing, with assets growing to $61.2 million and equity becoming positive Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2020 | Dec 31, 2019 | |:---|:---:|:---:| | Cash and cash equivalents | $58,765 | $6,939 | | Total assets | $61,239 | $7,658 | | Total current liabilities | $2,259 | $1,912 | | Total stockholders' equity (deficit) | $58,980 | ($4,769) | Consolidated Statement of Operations Data (in thousands) | | Year Ended Dec 31, 2020 | Year Ended Dec 31, 2019 | |:---|:---:|:---:| | Research and development | $10,004 | $2,684 | | General and administrative | $4,221 | $1,380 | | In-process R&D assets acquired | $32,057 | $— | | Net loss | ($46,487) | ($4,069) | | Net loss per share | ($6.32) | ($1.93) | Consolidated Statement of Cash Flows Data (in thousands) | | Year Ended Dec 31, 2020 | Year Ended Dec 31, 2019 | |:---|:---:|:---:| | Cash flows from operating activities | ($18,423) | ($2,771) | | Cash flows from investing activities | $3,582 | ($162) | | Cash flows from financing activities | $66,667 | $4,856 | Notes to Consolidated Financial Statements Notes detail the reverse merger accounting, a DHHS license agreement, a $42.7 million public offering, and a full valuation allowance against deferred tax assets - The merger with Tocagen on June 15, 2020 was accounted for as a reverse asset acquisition, resulting in a $32.1 million charge for acquired IPR&D assets[532][580][582] - The company has an exclusive license agreement with the DHHS, requiring a minimum annual payment of $100,000 beginning in 2021[586][587] - In November 2020, the company completed a public offering of 1,614,035 shares, raising net proceeds of $42.7 million[596] - As of December 31, 2020, the company had federal net operating loss (NOL) carryforwards of $256.5 million and state NOLs of $269.1 million[616][617]