Forte Biosciences(FBRX)
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Forte Biosciences(FBRX) - 2024 Q4 - Annual Report
2025-03-28 20:01
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].
Forte Biosciences (FBRX) Is a Great Choice for 'Trend' Investors, Here's Why
ZACKS· 2025-01-03 15:01
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].
Here's Why Momentum in Forte Biosciences (FBRX) Should Keep going
ZACKS· 2024-11-28 14:51
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].
Forte Biosciences (FBRX) Upgraded to Buy: What Does It Mean for the Stock?
ZACKS· 2024-11-19 18:01
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][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - Institutional investors often rely on earnings estimates to determine the fair value of stocks, leading to buying or selling actions that affect stock prices [4]. Company Performance and Investor Sentiment - The upgrade for Forte Biosciences reflects an improvement in its underlying business, which is expected to drive stock appreciation as investors respond to this positive trend [5][11]. - Analysts have raised earnings estimates for Forte Biosciences, with a 3.3% increase in the Zacks Consensus Estimate over the past three months [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have averaged a +25% annual return since 1988 [7][9]. - The upgrade places Forte Biosciences in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10][11].
Forte Biosciences(FBRX) - 2024 Q3 - Quarterly Report
2024-11-14 21:05
Financial Performance - Forte Biosciences reported a net loss of $8.39 million for the three months ended September 30, 2024, compared to a net loss of $9.96 million for the same period in 2023, reflecting a decrease of $1.56 million [83]. - The net loss for the nine months ended September 30, 2024, was approximately $28.3 million, compared to a net loss of $25.6 million for the same period in 2023, reflecting an increase of 10.6% [89]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $20.7 million, compared to $19.7 million for the same period in 2023 [95]. - The net change in cash and cash equivalents for the nine months ended September 30, 2024, was a decrease of $20.8 million, compared to an increase of $5.1 million for the same period in 2023 [94]. Expenses - Research and development expenses for the three months ended September 30, 2024, were $5.87 million, down from $6.37 million in the same period of 2023, a reduction of $0.50 million [83]. - General and administrative expenses decreased to $2.76 million for the three months ended September 30, 2024, from $3.85 million in the same period of 2023, a decrease of $1.09 million [83]. - Research and development expenses for the nine months ended September 30, 2024, were $16.0 million, a decrease of 12.0% from $18.3 million in the same period in 2023 [85]. - General and administrative expenses for the nine months ended September 30, 2024, were $13.3 million, an increase of 70.5% from $7.8 million in the same period in 2023 [86]. Cash Position - As of September 30, 2024, Forte had approximately $16.4 million in cash and cash equivalents [73]. - Cash and cash equivalents as of September 30, 2024, were approximately $16.4 million, with an accumulated deficit of approximately $146.8 million [89]. - The gross proceeds from the Private Placement on July 31, 2023, were $25.0 million, with issuance costs of $272 thousand [89]. Clinical Trials and Product Development - The Phase 1 trial of FB102 demonstrated a good safety profile with no dose-limiting toxicities observed, and significant reductions in NK cell pharmacodynamic markers of over 70% [73]. - Forte initiated a patient-based trial for celiac disease in Q3 2024, with top-line results expected in Q2 2025 [73]. - The company anticipates an increase in research and development expenses in the future as it continues to develop its lead product candidate, FB102 [85]. - The company has not generated any revenue from product sales or out-licensing and expects to incur ongoing losses as it develops FB102, currently in a Phase 1b clinical trial [90]. Market Potential - The global vitiligo treatment market was estimated at $1.2 billion in 2018 and is projected to reach $1.9 billion by 2026, indicating significant market potential for FB102 [73]. - 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 [73]. Stock Information - Forte's common stock is publicly traded on the Nasdaq Capital Market under the ticker symbol FBRX [73]. Future Outlook - Future capital requirements are difficult to forecast and will depend on various factors, including the initiation and progress of clinical trials and regulatory approvals [90].
Forte Biosciences(FBRX) - 2024 Q3 - Quarterly Results
2024-11-14 21:04
Financial Performance - Forte Biosciences reported research and development expenses of $5.9 million for Q3 2024, a decrease of 7.8% from $6.4 million in Q3 2023[4] - For the nine months ended September 30, 2024, research and development expenses totaled $16.0 million, down 12.5% from $18.3 million in the same period of 2023[5] - General and administrative expenses for Q3 2024 were $2.8 million, a decrease of 26.3% compared to $3.8 million in Q3 2023[6] - The company reported a net loss per share of $(4.54) for Q3 2024, compared to $(6.57) for Q3 2023, reflecting an improvement of 30.5%[7] Cash and Liabilities - As of September 30, 2024, Forte had $16.4 million in cash and cash equivalents, down from $37.1 million at the end of 2023[8] - Total current liabilities increased to $8.58 million as of September 30, 2024, compared to $3.67 million at the end of 2023[9] - Forte's accumulated deficit increased to $146.8 million as of September 30, 2024, compared to $118.5 million at the end of 2023[9] Clinical Development - Forte has initiated a clinical trial for FB102 in celiac disease, with topline data expected in Q2 2025[1] - The company has advanced FB102 into clinical trials, demonstrating a good safety profile in phase 1 studies[4] Stock Information - The company completed a 1:25 reverse stock split in August 2024, resulting in 1.46 million shares of common stock outstanding[8]
Forte Biosciences(FBRX) - 2024 Q2 - Quarterly Results
2024-08-14 20:37
Financial Performance - Forte Biosciences reported research and development expenses of $5.7 million for Q2 2024, down from $7.1 million in Q2 2023, primarily due to a $1.5 million decrease in manufacturing costs[5] - General and administrative expenses increased to $7.1 million in Q2 2024 from $1.9 million in Q2 2023, mainly due to higher legal and professional expenses[6] - The net loss per share for Q2 2024 was $(0.27), compared to $(0.42) for Q2 2023, indicating an improvement in loss per share year-over-year[7] - Research and development expenses for the first half of 2024 totaled $10.1 million, down from $11.9 million in the same period of 2023, reflecting a decrease in manufacturing costs[6] Cash and Equity Position - Forte ended Q2 2024 with approximately $24.5 million in cash and cash equivalents, down from $37.1 million at the end of 2023[7] - The total stockholders' equity decreased to $16.96 million as of June 30, 2024, from $35.31 million at the end of 2023, primarily due to accumulated deficit increases[9] - Forte's total assets decreased to $26.08 million as of June 30, 2024, from $38.98 million at the end of 2023, indicating a significant reduction in financial resources[9] Product Development - The company is advancing its FB102 program into a patient study for celiac disease, with first patient dosing expected in Q3 2024 and top-line results anticipated by Q2 2025[4] - Forte's FB102 demonstrated a good safety profile in the completed phase 1 healthy volunteer study, with significant reductions in NK cell pharmacodynamic markers observed[4] - The company is optimistic about the potential of FB102 across various autoimmune diseases, citing significant unmet needs in the market[2]
Forte Biosciences(FBRX) - 2024 Q2 - Quarterly Report
2024-08-14 20:05
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].
Forte Biosciences(FBRX) - 2024 Q1 - Quarterly Report
2024-05-13 20:15
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].
Forte Biosciences(FBRX) - 2024 Q1 - Quarterly Results
2024-05-13 20:06
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]