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, 2025 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 ...

Exhibit 99.1 FORTE BIOSCIENCES, INC. ANNOUNCES RESULTS AND PROVIDES UPDATE DALLAS, TX – AUGUST 14, 2025 – Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced its second quarter 2025 financial results and provided a business update. "I am deeply appreciative of the Forte team's incredible accomplishments in initiating 3 clinical trials for FB102 with data readouts shortly." said Forte Bi ...

Summary of Forte Biosciences (FBRX) Investor Webcast - June 23, 2025 Company Overview - **Company**: Forte Biosciences (FBRX) - **Focus**: Development of FV102, an antibody targeting celiac disease and other autoimmune conditions Key Points from the Call Industry and Product Development - **Celiac Disease**: Affects approximately 2.5 million people in the U.S., often underdiagnosed due to lack of treatment options [10] - **FV102**: An antibody targeting CD122, involved in the immune response related to celiac disease, showing positive results in Phase 1b trials [5][6] - **Phase 2 Study**: Initiating a Phase 2 trial with 100 patients, focusing on efficacy and safety, with data expected in 2026 [29][30] Clinical Trial Results - **Phase 1b Trial**: - 32 subjects enrolled, randomized 3:1 (FV102 to placebo) [17] - Positive histological and symptom data observed in treated subjects compared to placebo [5] - Significant reduction in intraepithelial lymphocyte (IEL) density in the FV102 group, indicating reduced inflammation [23] - 42% reduction in gluten-induced symptoms in the FV102 group, including nausea and abdominal pain [25][26] Mechanism of Action - **Mechanism**: FV102 blocks IL-2 and IL-15 signaling, preventing activation of autoreactive T cells and NK cells, while sparing regulatory T cells [6][7] - **Targeted Diseases**: Besides celiac disease, FV102 shows potential in treating vitiligo, alopecia, and type 1 diabetes [6][31] Safety Profile - **Adverse Events**: Only one grade 3 adverse event reported in the placebo group; overall safety profile consistent with previous studies [27][28] Future Directions - **Phase 2 Trial Design**: Will include a higher gluten challenge and focus on both histological and symptom endpoints [40][41] - **Long-term Goals**: Aim to demonstrate protection from gluten-induced gut damage and symptomatology, which could set the stage for future trials [64] Competitive Landscape - **Comparison with Other Treatments**: FV102's dual blockade of IL-2 and IL-15 is seen as a significant advantage over other therapies that focus solely on IL-15 [58][60] Additional Insights - **Clinical Relevance**: A change of around 30% in IEL count is considered significant for clinical benefit [37] - **Patient Experience**: Participants reported high tolerability to FV102, with many experiencing no symptoms during gluten challenges [60] Conclusion - Forte Biosciences is advancing its clinical development of FV102 for celiac disease, with promising Phase 1b results leading to a Phase 2 trial. The company aims to address significant unmet needs in autoimmune diseases through innovative therapeutic mechanisms.

FORTE BIOSCIENCES CLINICAL STAGE FB-102 3 FB102 CELIAC DISEASE PHASE 1B RESULTS JUNE 2025 1 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS 2 Certain statements contained in this presentation regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, and the Private Securities Litigation Act of 1995, known as the PSLRA. These include statements regarding management's intention, plans, beliefs, ...

Financial Performance - The net loss for Q1 2025 was $15.7 million, compared to a net loss of $7.4 million in Q1 2024, representing an increase in loss of $8.2 million[112]. - The net loss for Q1 2025 was $15.7 million, with an accumulated deficit of $169.7 million as of March 31, 2025[118]. - Total operating expenses for Q1 2025 were $16.1 million, compared to $7.8 million in Q1 2024, reflecting an increase of $8.3 million[112]. - General and administrative expenses decreased to $3.4 million for Q1 2025 from $3.5 million in Q1 2024, primarily due to a $1.0 million reduction in legal and professional expenses[115]. - Net cash used in operating activities for Q1 2025 was $10.4 million, compared to $6.7 million in Q1 2024[127]. - The company has not generated any revenue from product sales or out-licensing and has never been profitable[118]. Cash Position - The company had approximately $45.9 million in cash and cash equivalents as of March 31, 2025[99]. - Cash and cash equivalents were approximately $45.9 million as of March 31, 2025, expected to fund operations for at least 12 months[122]. - The gross proceeds from the 2024 Private Placement were $53.0 million, with issuance costs of $3.4 million[120]. Research and Development - Research and development expenses increased to $12.7 million for Q1 2025, up from $4.4 million in Q1 2024, primarily due to an $8.9 million rise in manufacturing expenses for clinical trials[113]. - FB102, the current lead product candidate, is in Phase 1 clinical development, targeting autoimmune-related indications[123]. - A Phase 1 trial of FB102 demonstrated a good safety profile, with significant reductions in NK cell pharmacodynamic markers of over 70%[94]. - The company initiated a patient-based trial for celiac disease in Q3 2024, with top-line results expected in Q2 2025[94]. - The company expects to incur ongoing losses as it develops FB102, with future capital requirements difficult to forecast[123]. Market Potential - The global vitiligo treatment market is projected to reach $1.9 billion by 2026, indicating significant market potential for FB102[96]. - 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%[97]. Securities and Financing - Forte filed a new shelf registration statement for the issuance of up to $300 million in securities, effective April 2025[100]. - The company filed a shelf registration statement to register the issuance of up to $300 million in securities in March 2025[119]. - Net cash provided by investing activities for Q1 2025 was primarily due to proceeds from the redemption of U.S. treasury bills[130].

Financial Performance - Forte Biosciences reported a net loss per share of $(12.17) for the year ended December 31, 2024, compared to $(24.92) for 2023, indicating an improvement in loss per share by 51.1%[6]. - Forte's accumulated deficit increased to $(153.998) million in 2024 from $(118.520) million in 2023, reflecting a rise of 29.9% in accumulated losses[8]. Expenses - Research and development expenses decreased to $21.2 million in 2024 from $21.9 million in 2023, a reduction of $0.7 million, primarily due to a $7.0 million decrease in manufacturing expenses[4]. - General and administrative expenses increased to $15.4 million in 2024, up from $10.6 million in 2023, reflecting a rise of $4.8 million mainly due to higher professional and legal expenses[5]. Cash and Assets - Forte ended 2024 with $58.4 million in cash, cash equivalents, and short-term investments, down from $37.1 million in cash and cash equivalents at the end of 2023[6]. - Total current assets increased to $61.3 million as of December 31, 2024, compared to $38.3 million in 2023, reflecting a growth of 60.0%[8]. Liabilities - Total liabilities rose to $9.1 million in 2024 from $3.7 million in 2023, an increase of 147.0%[8]. Clinical Trials - The company initiated a celiac patient trial for FB102, with nearly half of the patients having completed both dosing and gluten challenge, and topline results expected in Q2 2025[3]. - The company anticipates dosing the first patient in the FB102 vitiligo trial shortly, indicating ongoing commitment to expanding its clinical programs[3]. Fundraising - Forte raised $53.0 million in gross proceeds from an over-subscribed private placement in November 2024, enhancing its financial position[6].

Core Viewpoint - Forte Biosciences, Inc. (FBRX) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][2]. Earnings Estimates and Stock Price Movement - The change in earnings estimates is strongly correlated with near-term stock price movements, with institutional investors using these estimates to determine fair value [3]. - An increase in earnings estimates typically leads to higher fair value for stocks, prompting institutional investors to buy or sell, which in turn affects stock prices [3]. Company Performance Indicators - Forte Biosciences is projected to earn -$3.60 per share for the fiscal year ending December 2025, reflecting a year-over-year change of 70.4% [7]. - Over the past three months, the Zacks Consensus Estimate for Forte Biosciences has increased by 5.3%, indicating a positive trend in earnings estimates [7]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [6]. - The Zacks rating system maintains a balanced distribution of 'buy' and 'sell' ratings, ensuring that only the top 20% of stocks are positioned for superior earnings estimate revisions [8][9]. Investment Implications - The upgrade of Forte Biosciences to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [9].

Financial Position - As of December 31, 2024, the company had approximately $58.4 million in cash, cash equivalents, and short-term investments[343]. - Cash, cash equivalents, and short-term investments totaled approximately $58.4 million as of December 31, 2024, expected to fund operations for at least 12 months[380]. - Net cash used in operating activities for 2024 was $30.7 million, compared to $28.7 million in 2023, indicating an increase in cash outflow[387]. - Net cash provided by financing activities in 2024 was $51.9 million, primarily from a private placement of common stock and pre-funded warrants[390]. - The company has not generated any revenue from product sales and has incurred operating losses since inception, with an accumulated deficit of $154.0 million as of December 31, 2024[375]. Private Placement - The gross proceeds from the 2024 Private Placement were $53.0 million, with issuance costs of $3.4 million[344]. - The gross proceeds from the 2023 Private Placement were $25.0 million, with issuance costs of $272 thousand[345]. - The gross proceeds from the 2024 Private Placement were $53.0 million, with issuance costs of $3.4 million[377]. Research and Development - The company anticipates research and development expenses to continue to increase as it develops its lead product candidate, FB102[353]. - The company anticipates an increase in research and development expenses as it continues to develop its lead product candidate, FB102, currently in Phase 1 clinical development[371]. - Research and development expenses decreased to $21.2 million in 2024 from $21.9 million in 2023, primarily due to a $7.0 million decrease in manufacturing expenses[370]. Operating Expenses - Total operating expenses for the year ended December 31, 2024, were $36.6 million, an increase of $4.1 million from $32.5 million in 2023[369]. - General and administrative expenses increased to $15.4 million in 2024 from $10.6 million in 2023, reflecting a rise of $4.8 million mainly due to higher professional and legal expenses[372]. Clinical Trials and Product Development - FB102 demonstrated significant reductions in NK cell pharmacodynamic markers, with reductions of approximately 70% in Phase 1 trials[338]. - The company is currently enrolling patients in a trial for celiac disease, with top-line results expected in the second quarter of 2025[338]. Market Overview - The global vitiligo treatment market was estimated at $1.2 billion in 2018 and is projected to reach $1.9 billion by 2026[340]. - 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[341]. - Celiac disease affects approximately 2.5 million people in the U.S., with 0.3% to 0.5% of patients being non-responsive to a gluten-free diet[339]. Net Loss - The net loss for the year ended December 31, 2024, was $35.5 million, compared to a net loss of $31.5 million in 2023, representing an increase of $4.0 million[375].

Core Viewpoint - The article emphasizes the importance of confirming the sustainability of a trend in stock investing, particularly for short-term trades, and highlights the potential of stocks like Forte Biosciences, Inc. (FBRX) that show strong price momentum and solid fundamentals [1][2][3]. Group 1: Stock Performance - FBRX has experienced a significant price increase of 425.4% over the past 12 weeks, indicating strong investor interest and potential upside [4]. - The stock has maintained a price increase of 3% over the past four weeks, suggesting that the upward trend is still intact [5]. - Currently, FBRX is trading at 86.1% of its 52-week high-low range, indicating it may be on the verge of a breakout [5]. Group 2: Fundamental Strength - FBRX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, which are critical for near-term price movements [6]. - The stock has an Average Broker Recommendation of 1 (Strong Buy), reflecting high optimism from the brokerage community regarding its near-term performance [7]. Group 3: Investment Strategy - The article suggests using the "Recent Price Strength" screen to identify stocks like FBRX that are on an uptrend supported by strong fundamentals [3][8]. - It also mentions that there are over 45 Zacks Premium Screens available for investors to find stocks that align with their investment strategies [8].

Core Viewpoint - The sustainability of a trend is crucial for successful short-term investing, and confirming fundamental factors is essential to maintain momentum in stocks [1][2]. Group 1: Trend Analysis - Timing entries into a trend significantly impacts investment success, as trends can reverse unexpectedly, leading to potential losses [1][2]. - A unique short-term trading strategy, the "Recent Price Strength" screen, helps identify stocks with strong fundamentals that can sustain their upward momentum [3]. Group 2: Company Spotlight - Forte Biosciences, Inc. (FBRX) - FBRX has shown a solid price increase of 171.1% over the past 12 weeks, indicating strong investor interest [4]. - The stock has experienced a remarkable price increase of 326.5% over the last four weeks, suggesting that the upward trend is still intact [5]. - Currently, FBRX is trading at 81.5% of its 52-week high-low range, indicating a potential breakout opportunity [5]. Group 3: Fundamental Strength - FBRX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises [6]. - The stock's Average Broker Recommendation is 1 (Strong Buy), reflecting high optimism from the brokerage community regarding its near-term price performance [7]. Group 4: Additional Opportunities - Besides FBRX, there are other stocks that meet the criteria of the "Recent Price Strength" screen, providing additional investment opportunities [8]. - The Zacks Research Wizard can assist in backtesting stock-picking strategies to ensure they have produced profitable results in the past [9].