Financial Position - As of September 30, 2025, the company had approximately $93.4 million in cash and cash equivalents[111]. - Cash and cash equivalents were approximately $93.4 million as of September 30, 2025, expected to fund operations for at least 12 months[139]. - The net loss for the nine months ended September 30, 2025, was $44.6 million, with an accumulated deficit of $198.6 million as of the same date[133]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $34.4 million, compared to $20.7 million for the same period in 2024[145]. - Future capital requirements are uncertain and will depend on various factors, including the progress of clinical trials and potential strategic alliances[140]. Public Offering - The company completed a public offering on June 25, 2025, selling 5,630,450 shares at $12.00 per share, raising gross proceeds of $75.0 million[112]. - The gross proceeds from the public offering on June 25, 2025, were $75.0 million, with underwriting costs of approximately $5.1 million[135]. Research and Development - Research and development expenses for Q3 2025 were $15.2 million, up from $5.9 million in Q3 2024, primarily due to a $9.7 million increase in clinical and manufacturing expenses related to ongoing clinical trials[125]. - For the nine months ended September 30, 2025, research and development expenses totaled $36.5 million, compared to $16.0 million for the same period in 2024, reflecting a $21.6 million increase in manufacturing and clinical expenses[127]. Clinical Trials - The Phase 1 trial of FB102 demonstrated a good safety profile with no dose limiting toxicities and significant reductions in NK cell pharmacodynamic markers (greater than approximately 70%)[101]. - In the Phase 1b celiac disease study, FB102 showed a statistically significant benefit on the composite histological VCIEL endpoint with a mean change of -1.849 for placebo compared to 0.079 for FB102 (p=0.0099)[103]. - The gluten challenge induced GI symptoms showed a 42% benefit for FB102 treated subjects (4.0 events per subject) compared to placebo (6.9 events per subject)[105]. - The company initiated a Phase 2 celiac study in July 2025, with topline readout expected in 2026[106]. Market Potential - The global vitiligo treatment market is projected to reach approximately $2.3-2.7 billion by 2032-2034[109]. - The global alopecia treatment market is valued at around $3-3.5 billion in 2024, with potential to reach $6 billion by 2032-2034[109]. Intellectual Property - The company has one US patent and multiple pending applications related to the FB102 program, with estimated expiration dates from 2043 to 2046[115]. Revenue and Sales - The company has no products approved for commercial sale and has not generated any revenue from product sales[118]. - The company has no products approved for commercial sale and has not generated any revenue from product sales or other sources[133]. Administrative Expenses - General and administrative expenses for Q3 2025 were $3.2 million, an increase from $2.8 million in Q3 2024, mainly due to a $0.6 million rise in personnel-related expenses[129]. - General and administrative expenses for the nine months ended September 30, 2025, decreased to $9.6 million from $13.3 million in 2024, primarily due to a $6.0 million reduction in professional and legal expenses[130]. Regulatory Classification - The company is classified as a smaller reporting company under Rule 12b-2 of the Securities Exchange Act of 1934, thus not required to provide detailed market risk disclosures[153].

Financial Performance - Forte Biosciences reported research and development expenses of $15.2 million for Q3 2025, up from $5.9 million in Q3 2024, primarily due to increased clinical and manufacturing costs[3]. - For the nine months ended September 30, 2025, research and development expenses totaled $36.5 million, compared to $16.0 million for the same period in 2024, reflecting a $21.6 million increase in manufacturing and clinical expenses[4]. - General and administrative expenses for Q3 2025 were $3.2 million, an increase from $2.8 million in Q3 2024, mainly due to personnel-related costs[6]. - Net loss per share for Q3 2025 was $(0.99), compared to $(4.54) for Q3 2024, indicating a reduction in losses year-over-year[8]. - Forte's total operating expenses for the nine months ended September 30, 2025, were $46.1 million, compared to $29.3 million for the same period in 2024[12]. Cash and Assets - The company ended Q3 2025 with $93.4 million in cash and cash equivalents, a significant increase from $22.2 million at the end of 2024[9]. - Total assets as of September 30, 2025, were $97.1 million, up from $61.6 million at the end of 2024, driven by increased cash reserves[11]. - The accumulated deficit increased to $(198.6) million as of September 30, 2025, compared to $(154.0) million at the end of 2024[11]. Clinical Trials and Research - Forte anticipates topline results from three key clinical trials for FB102 in 2026, including phase 2 in celiac disease and phase 1b in vitiligo and alopecia areata[2]. - The company has expanded enrollment for the FB102 phase 2 celiac disease trial to US sites, with results expected in 2026[2].

Core Insights - AlphaQuest LLC increased its stake in Forte Biosciences by 300.7% in Q2, owning 16,897 shares valued at $218,000 [2] - Analysts have mixed ratings on Forte Biosciences, with a consensus rating of "Moderate Buy" and an average price target of $68.00 [3] - Forte Biosciences reported an EPS of ($0.96) for the last quarter, exceeding the consensus estimate of ($1.21) by $0.25 [5] Company Overview - Forte Biosciences is a biopharmaceutical company based in Dallas, Texas, focusing on developing treatments for autoimmune diseases [6] - The company is working on the FB-102 program, targeting conditions such as graft-versus-host disease, vitiligo, and alopecia areata [6] Stock Performance - Forte Biosciences shares opened at $12.94, with a market capitalization of $160.84 million and a P/E ratio of -1.88 [4] - The stock has experienced a 12-month low of $4.11 and a high of $28.68 [4]

Financial Position - As of June 30, 2025, the company had approximately $106.1 million in cash and cash equivalents[108]. - The company raised $75.0 million from a public offering on June 25, 2025, with underwriting costs of approximately $5.1 million[133]. - As of June 30, 2025, the company had cash and cash equivalents of approximately $106.1 million, expected to fund operations for at least 12 months[136]. - Net cash used in operating activities for the first half of 2025 was $20.4 million, compared to $12.6 million in the same period of 2024[143]. - The net loss for the first half of 2025 was $26.9 million, compared to a net loss of $19.9 million in the same period of 2024, reflecting ongoing operational challenges[131]. - The company has not generated any revenue from product sales and has incurred operating losses since inception[131]. Clinical Trials and Research - The Phase 1b trial for celiac disease enrolled 32 subjects, showing a statistically significant benefit on the composite histological VCIEL endpoint with a p-value of 0.0099[100]. - FB102 demonstrated a 42% reduction in gluten challenge induced GI symptoms compared to placebo, with 4.0 events per subject in the FB102 group versus 6.9 in the placebo group[102]. - The company initiated a Phase 2 celiac study in July 2025, with topline readout expected in 2026[103]. - FB102 showed significant reductions in NK cell pharmacodynamic markers, with reductions greater than approximately 70% observed in Phase 1 trials[98]. - Research and development expenses for Q2 2025 were $8.6 million, up from $5.7 million in Q2 2024, primarily due to a $3.8 million increase in clinical expenses for Phase 1b trials[123]. - For the first half of 2025, research and development expenses totaled $21.3 million, compared to $10.1 million in the same period of 2024, driven by an $11.7 million increase in manufacturing and clinical expenses[125]. Market Outlook - The global vitiligo treatment market is projected to reach approximately $2.3-2.7 billion by 2032-2034, while the alopecia treatment market could reach $6 billion in the same timeframe[106]. Regulatory and Strategic Considerations - The company has a pending PCT application and multiple pending US applications related to the FB102 program, with estimated expiration dates from 2043 to 2046[112]. - Future capital requirements will depend on various factors, including the progress of clinical trials and potential strategic alliances[137]. - The company is actively monitoring the impacts of global events, including economic uncertainty and geopolitical tensions, on its business operations[114]. Administrative Expenses - General and administrative expenses decreased to $3.0 million in Q2 2025 from $7.1 million in Q2 2024, mainly due to a $4.8 million reduction in professional and legal expenses[127]. - Other income for Q2 2025 increased to $330,000 from $307,000 in Q2 2024, primarily due to higher interest income[122].

Clinical Trials - Forte Biosciences expects three clinical trial readouts for FB102 in 2026, including phase 2 in celiac disease and phase 1b in vitiligo and alopecia areata[1][2]. - The company anticipates further increases in research and development expenses as it advances FB102 through ongoing clinical trials[7]. Financial Performance - The company reported research and development expenses of $8.6 million for Q2 2025, up from $5.7 million in Q2 2024, primarily due to a $3.8 million increase in clinical expenses[5]. - For the six months ended June 30, 2025, research and development expenses totaled $21.3 million, compared to $10.1 million for the same period in 2024, reflecting an increase of $11.7 million in manufacturing and clinical expenses[6]. - General and administrative expenses decreased to $3.0 million in Q2 2025 from $7.1 million in Q2 2024, mainly due to a $4.8 million reduction in professional and legal expenses[8]. - The company reported a net loss per share of $(0.96) for Q2 2025, compared to $(6.78) for Q2 2024[10]. - Forte's accumulated deficit increased to $(180.9) million as of June 30, 2025, compared to $(154.0) million at the end of 2024[13]. Cash and Funding - As of June 30, 2025, Forte had $106.1 million in cash and cash equivalents, an increase from $22.2 million at the end of 2024[11][13]. - The company closed a public offering on June 25, 2025, raising net proceeds of $69.9 million from the sale of 5,630,450 shares at $12.00 per share[3]. - An additional $1.7 million was raised from the exercise of the over-allotment option for 148,258 shares in July 2025[4].

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].