Financial Position - Forte Biosciences has approximately $24.5 million in cash and cash equivalents as of June 30, 2024[87]. - The accumulated deficit as of June 30, 2024, was approximately $138.5 million, indicating ongoing financial challenges[104]. - As of June 30, 2024, the company had cash and cash equivalents of approximately $24.5 million, which is expected to fund operations for at least 12 months[104]. - Net cash used in operating activities for the six months ended June 30, 2024, was $12.6 million, compared to $10.7 million for the same period in 2023, reflecting an increase of about 17.7%[111]. - The company has not generated any revenue from product sales or out-licensing, indicating a reliance on external funding for operations[107]. Revenue and Expenses - Forte has no products approved for commercial sale and has not generated any revenue from product sales[92]. - Research and development expenses for the three months ended June 30, 2024, were $5.7 million, a decrease of approximately 19.6% from $7.1 million in the same period in 2023[99]. - General and administrative expenses for the three months ended June 30, 2024, increased to $7.1 million from $1.9 million, reflecting a significant rise of approximately 273.7%[102]. - The net loss for the six months ended June 30, 2024, was approximately $19.9 million, compared to a net loss of $15.6 million for the same period in 2023, representing an increase of about 27.5%[101]. - Other income for the three months ended June 30, 2024, was $307,000, up from $138,000 in the same period in 2023, marking a growth of approximately 122.5%[99]. Research and Development - Forte plans to initiate a patient study in celiac disease in Q3 2024, with top-line results expected by Q2 2025[83]. - Research and development expenses are expected to increase as Forte continues to develop FB102[94]. - The company anticipates an increase in research and development expenses in the future as it continues to develop its lead product candidate, FB102[101]. Market Overview - The estimated prevalence of celiac disease in the U.S. is 1 in 133, equating to approximately 2.5 million people[84]. - The global vitiligo treatment market was valued at $1.2 billion in 2018 and is projected to reach $1.9 billion by 2026[85]. - The global alopecia treatment market was valued at $2.7 billion in 2018, projected to reach $3.9 billion by 2026, with a CAGR of 4.6%[87]. Intellectual Property - Forte owns one U.S. patent related to skin conditions, with an estimated expiration date of 2039, and three pending PCT applications related to FB102, expiring between 2043-2044[90]. Private Placement - The gross proceeds from the Private Placement on July 31, 2023, were approximately $25 million, with issuance costs of $272,000[88]. - The gross proceeds from the private placement on July 31, 2023, were approximately $25 million, which will support ongoing operations and development[105].

Financial Performance - Forte Biosciences reported a net loss of approximately $7.4 million for the three months ended March 31, 2024, compared to a net loss of $6.8 million for the same period in 2023, reflecting an increase in loss of $667,000 [117]. - General and administrative expenses increased to $3.5 million for the three months ended March 31, 2024, from $2.1 million in the same period in 2023, driven by a $1.4 million increase in legal and professional expenses [120]. - For the three months ended March 31, 2024, net cash used in operating activities was $6.7 million, compared to $5.2 million for the same period in 2023, reflecting an increase in net loss from $6.8 million to $7.4 million [131]. - The company has not generated any revenue from product sales or out-licensing and expects ongoing losses as it develops its lead product candidate, FB102, currently in Phase 1 clinical trials [127]. Research and Development - Research and development expenses were $4.4 million for the three months ended March 31, 2024, a decrease of $434,000 from $4.8 million in the same period in 2023, primarily due to a reduction in manufacturing costs [118]. - Forte anticipates research and development expenses to continue to increase as the company advances its FB102 program through clinical trials [112]. - Forte's lead product candidate, FB102, is currently in a Phase 1 trial, with patient-based studies anticipated to begin in 2024 [97]. Market Opportunity - The U.S. prevalence of acute graft-versus-host disease (GvHD) is estimated at approximately 5,000 cases, occurring in up to 50% of allogeneic stem cell transplant recipients [99]. - The global vitiligo treatment market was valued at $1.2 billion in 2018 and is projected to reach $1.9 billion by 2026, indicating a significant market opportunity for FB102 [101]. - The global alopecia treatment market was valued at $2.7 billion in 2018 and is projected to reach $3.9 billion by 2026, with a CAGR of 4.6% from 2019 to 2026 [102]. Capital and Funding - As of March 31, 2024, Forte had approximately $30.4 million in cash and cash equivalents, which is expected to fund operations for at least 12 months [124]. - The company has a shelf registration statement effective for raising up to $300 million in additional capital, but its ability to access this funding is restricted due to market value limitations [126]. - On July 31, 2023, the company issued 15,166,957 shares at $1.006 per share and 9,689,293 pre-funded warrants at $1.005, raising approximately $25 million in gross proceeds [125]. - Future capital requirements are uncertain and will depend on various factors, including clinical trial outcomes and regulatory approvals [128]. - The company may face dilution if it raises additional funds by issuing equity securities, which could also impose operational restrictions [128]. Cash Flow and Expenses - Net cash used in investing activities for the three months ended March 31, 2024, was minimal, primarily due to the purchase of property and equipment [132]. - The company incurred $272,000 in issuance costs related to the recent private placement of shares and warrants [125]. - Net cash provided by financing activities for the three months ended March 31, 2023, was primarily due to the issuance of shares under the employee stock purchase plan [133]. Accumulated Deficit - The company has an accumulated deficit of approximately $125.9 million as of March 31, 2024 [123]. - The company has not entered into any off-balance sheet arrangements or holds variable interest entities [134].

Financial Performance - Forte Biosciences reported research and development expenses of $4.4 million for Q1 2024, a decrease from $4.8 million in Q1 2023, primarily due to a $2.7 million reduction in manufacturing costs[4] - General and administrative expenses increased to $3.5 million in Q1 2024 from $2.1 million in Q1 2023, mainly due to higher legal and professional expenses[5] - The net loss per share improved to ($0.16) in Q1 2024 compared to ($0.32) in Q1 2023[6] - Total operating expenses for Q1 2024 were $7.8 million, up from $6.9 million in Q1 2023[9] Cash and Assets - Forte ended Q1 2024 with approximately $30.4 million in cash and cash equivalents, down from $37.1 million at the end of 2023[8] - The total assets decreased to $32.0 million as of March 31, 2024, from $39.0 million at the end of 2023[8] - The accumulated deficit increased to $125.9 million as of March 31, 2024, compared to $118.5 million at the end of 2023[8] Shareholder Information - The weighted average shares outstanding increased to 46,082,861 in Q1 2024 from 21,006,680 in Q1 2023[9] Research and Development - The company anticipates completing the multiple ascending dose cohorts of the FB102 phase 1 trial around mid-year 2024[3] - Forte plans to initiate patient-based studies for FB102 before the end of 2024, indicating significant potential in treating autoimmune diseases[3]

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 sep For the fiscal year ended December 31, 2023 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 FORTE BIOSCIENCES, INC. (Exact name of Registrant as specified in its Charter) Delaware 26-1243872 (State or other jurisdic ...

Exhibit 99.1 FORTE BIOSCIENCES, INC. ANNOUNCES 2023 RESULTS AND PROVIDES BUSINESS UPDATE DALLAS, TX – MARCH 18, 2024 – Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced its 2023 results and provided a business update. 2023 Business Highlights "Forte achieved a major milestone by advancing FB-102 into the clinic and beating the timelines we targeted in our third quarter business update ...

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, 2023 Delaware 26-1243872 (State or other jurisdiction of incorporation or organization) 3060 Pegasus Park Drive, Building 6 Dallas, Texas 75247 (Address of principal executive offices) (Zip Code) (I.R.S. Employer Identification No.) Registrant's telephone number, including area code: ( ...

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, 2023 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 FORTE BIOSCIENCES, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 26-1243872 (State or other jurisdict ...

OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 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, 2023 Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or f ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 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 FORTE BIOSCIENCES, INC. (Exact name of Registrant as specified in its Charter) Delaware 26-1243872 (State or other jurisdiction of incorporation or organization) 3060 Pegasus Park Drive, Building 6 Dallas, Texas 75247 (Address of principal executive offices) (Zip Code) (I.R.S. E ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock FBRX The Nasdaq Stock Market LLC 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, 2022 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 ...