UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38052 | --- | --- | |-------------------------------------------------------------------------------------------------------- ...

Financial Performance - Forte Biosciences reported a net loss of $5.812 million for Q2 2021, a decrease of $28.949 million compared to a net loss of $34.761 million in Q2 2020[118]. - Total operating expenses for Q2 2021 were $5.747 million, down from $34.754 million in Q2 2020, reflecting a decrease of $29.007 million[118]. - The net loss for the six months ended June 30, 2021, was approximately $10.6 million, with an accumulated deficit of about $62.1 million as of the same date[127]. - Net cash used in operating activities for the six months ended June 30, 2021, was $8.0 million, compared to $6.9 million for the same period in 2020[142]. Research and Development - Research and development expenses increased to $3.523 million in Q2 2021 from $1.937 million in Q2 2020, an increase of $1.586 million[118]. - The company anticipates significant increases in research and development expenses as it continues to advance the FB-401 program through clinical trials[135]. - The company recognized an expense of $32.1 million for in-process research and development assets acquired during the merger with Tocagen[112]. - Research and development expenses increased to $3.5 million for Q2 2021, up from $1.9 million in Q2 2020, representing an increase of approximately 84.2%[121]. Clinical Trials - The company completed a Phase 1/2a study of FB-401, showing nearly 80% improvement in atopic dermatitis (AD) disease activity in pediatric subjects[100]. - In the Phase 1/2a trial, 90% of pediatric patients achieved at least a 50% improvement in disease activity, with 70% achieving a 75% improvement[100]. - Forte initiated a multicenter, placebo-controlled clinical trial of FB-401 in September 2020, enrolling 154 subjects, with preliminary results expected in Q3 2021[101]. Revenue and Funding - The company has not generated any revenue from product sales and expects future revenue to fluctuate based on collaborations and licensing agreements[106]. - The company has not generated any revenue from product sales or out-licensing and does not expect to do so until regulatory approval is obtained[134]. - The company raised net cash proceeds of approximately $19.4 million in connection with the Merger, along with an additional $4.6 million from a stock issuance[128]. - Forte incurred $44,000 in offering costs related to a shelf registration statement effective in June 2021, allowing for the potential to raise up to $300 million[96]. Expenses - General and administrative expenses for Q2 2021 were $2.224 million, an increase of $1.464 million compared to $0.760 million in Q2 2020[118]. - General and administrative expenses rose to $2.2 million for Q2 2021, compared to $0.8 million in Q2 2020, marking a 175% increase[122]. - The company expects general and administrative expenses to increase substantially due to staff expansion and higher compliance costs associated with being a public company[124]. Cash Position - Cash and cash equivalents were approximately $50.8 million as of June 30, 2021, expected to fund operations for at least 12 months[133]. Off-Balance Sheet Arrangements - The company has not entered into any off-balance sheet arrangements and does not have holdings in variable interest entities[145].

Forte Biosciences, Inc. (NASDAQ:FBRX) Q1 2021 Earnings Conference Call May 10, 2021 4:30 PM ET Company Participants Paul Wagner - CEO Dan Birch - CMO Tony Riley - CFO Conference Call Participants Mohit Bansal - Citigroup Kumar Raja - Brookline Capital Markets Michael Higgins - Ladenburg Thalmann Kalpit Patel - B. Riley Operator Welcome to Forte Biosciences First Quarter 2021 Conference Call. My name is David and I will be the operator for this call. On the call are Paul Wagner, Chairman and Chief Executive ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38052 | --- | --- | --- | --- | --- | |------------------------------------------------------------------------------------------ ...

Part I [Business](index=4&type=section&id=Item%201.%20Business) 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](index=11&type=chunk) - In June 2020, Forte completed a reverse merger with Tocagen, Inc, becoming a publicly traded company on the Nasdaq under the symbol **FBRX**[12](index=12&type=chunk) - 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](index=13&type=chunk)[40](index=40&type=chunk) - 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](index=49&type=chunk)[51](index=51&type=chunk) [Risk Factors](index=21&type=section&id=Item%201A.%20Risk%20Factors) 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](index=126&type=chunk)[131](index=131&type=chunk) - Forte's prospects are **highly dependent on its single product candidate, FB-401**, which involves a lengthy, expensive, and uncertain development process[141](index=141&type=chunk)[154](index=154&type=chunk)[166](index=166&type=chunk) - 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](index=340&type=chunk)[346](index=346&type=chunk) - 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](index=280&type=chunk)[286](index=286&type=chunk) - The company faces significant competition from major pharmaceutical companies with greater resources, such as **Regeneron/Sanofi (Dupixent) and Pfizer (Eucrisa)**[182](index=182&type=chunk)[183](index=183&type=chunk) [Unresolved Staff Comments](index=65&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments - None[390](index=390&type=chunk) [Properties](index=65&type=section&id=Item%202.%20Properties) 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](index=391&type=chunk) [Legal Proceedings](index=65&type=section&id=Item%203.%20Legal%20Proceedings) The company reports no legal proceedings - None[392](index=392&type=chunk) [Mine Safety Disclosures](index=65&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[393](index=393&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=66&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) 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](index=397&type=chunk) - The company has never declared or paid cash dividends and does not intend to in the foreseeable future[399](index=399&type=chunk) - There were **no repurchases of common stock in 2020**[402](index=402&type=chunk) [Selected Financial Data](index=66&type=section&id=Item%206.%20Selected%20Financial%20Data) As a smaller reporting company, this information is not required - Not required as the company is a "smaller reporting company"[404](index=404&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=67&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=440&type=chunk) - 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](index=441&type=chunk) - 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](index=442&type=chunk) - 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](index=449&type=chunk)[444](index=444&type=chunk) 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](index=74&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, this information is not required - Not required as the company is a "smaller reporting company"[466](index=466&type=chunk) [Financial Statements and Supplementary Data](index=74&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) 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](index=467&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=74&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no disagreements with its accountants - None[468](index=468&type=chunk) [Controls and Procedures](index=74&type=section&id=Item%209A.%20Controls%20and%20Procedures) 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](index=470&type=chunk) - Management concluded that the company's internal control over financial reporting was **effective** as of December 31, 2020, based on the COSO framework[472](index=472&type=chunk) [Other Information](index=75&type=section&id=Item%209B.%20Other%20Information) The company reports no other information - None[477](index=477&type=chunk) Part III [Directors, Executive Officers, Corporate Governance, Executive Compensation, Security Ownership, and Related Matters](index=76&type=section&id=Items%2010-14) 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](index=480&type=chunk)[481](index=481&type=chunk)[482](index=482&type=chunk)[483](index=483&type=chunk)[484](index=484&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=77&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) 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](index=487&type=chunk) - Financial statement schedules are omitted because they are not applicable or the information is included in the financial statements or notes[488](index=488&type=chunk) [Form 10-K Summary](index=81&type=section&id=Item%2016%20Form%2010-K%20Summary) The company has elected not to include a Form 10-K summary - The Company has elected to not include a summary[503](index=503&type=chunk) Financial Statements [Report of Independent Registered Public Accounting Firm](index=84&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) 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](index=515&type=chunk) [Consolidated Financial Statements](index=85&type=section&id=Consolidated%20Financial%20Statements) 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](index=89&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) 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](index=532&type=chunk)[580](index=580&type=chunk)[582](index=582&type=chunk) - The company has an exclusive license agreement with the DHHS, requiring a minimum annual payment of **$100,000 beginning in 2021**[586](index=586&type=chunk)[587](index=587&type=chunk) - In November 2020, the company completed a public offering of 1,614,035 shares, raising net proceeds of **$42.7 million**[596](index=596&type=chunk) - 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](index=616&type=chunk)[617](index=617&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38052 | --- | --- | --- | --- | --- | |-------------------------------------------------------------------------------------- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38052 | --- | --- | --- | --- | --- | |------------------------------------------------------------------------------------------- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38052 TOCAGEN INC. (Exact name of registrant as specified in its charter) Delaware 26 - 1243872 (State or other jurisdiction of ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-38052 | --- | --- | |-----------------------------------------------------------------------------------------------------|---------- ...

Summary of Tocagen Inc. and Forte Biosciences Merger Conference Call Company Overview - **Companies Involved**: Tocagen Inc. (TOCA) and Forte Biosciences - **Date of Call**: February 20, 2020 Key Points from the Conference Call Merger Announcement - Tocagen and Forte have agreed to merge, creating a dermatology-focused company with a lead asset, FB-401, for atopic dermatitis [6][8] - The merger follows Tocagen's strategic review after disappointing Phase 3 results in September 2019 [6] Financial Structure - Tocagen's equity holders are expected to own approximately 25.5% of the combined company, while Forte's equity holders will own 74.5% on a fully diluted basis [7] - The combined company is projected to have a cash balance of approximately $25 million post-merger [8][11] Product Development - FB-401 is a live biotherapeutic developed for inflammatory skin diseases, particularly atopic dermatitis [9][10] - There are approximately 17 million atopic dermatitis patients in the US, with a significant unmet need for effective treatments, especially in pediatrics [10][15] - The Phase 1-2A clinical data for FB-401 shows significant efficacy and a favorable safety profile in both pediatric and adult populations [10][12] Clinical Trials and Data - The Phase 1-2A trial included 10 adults and 20 pediatric patients, demonstrating a 50% improvement in atopic dermatitis scores with no adverse events reported [17][19] - The next Phase 2 study is expected to start by mid-2020, with data readouts anticipated in mid-2021 [12][20] Intellectual Property - Forte holds extensive intellectual property protection for FB-401, including four issued patents covering composition and use, with protection lasting until at least 2037 [10][20] Management and Advisory Team - The merged company will be led by Forte's current CEO, Paul Wagner, who has a strong background in advancing the company through critical milestones [8][9] - The scientific advisory board includes prominent figures in dermatology, enhancing the company's credibility and expertise in the field [13] Future Outlook - The merger is expected to create significant shareholder value by addressing unmet clinical needs in inflammatory skin diseases, particularly for pediatric patients [21][22] - The next 12 to 18 months are projected to be eventful with the publication of Phase 1-2A data and the anticipated start of the next trial [20] Additional Important Information - The call included a reminder about the forward-looking statements and associated risks, encouraging listeners to review SEC filings for more detailed information [3][4] - The merger aims to leverage the strengths of both companies to enhance the development and commercialization of innovative therapies for dermatological disorders [6][21]