Forte Biosciences(FBRX)

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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]
Forte Biosciences(FBRX) - 2023 Q4 - Annual Report
2024-03-18 20:20
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 ...
Forte Biosciences(FBRX) - 2023 Q4 - Annual Results
2024-03-18 20:18
[Business Highlights & Outlook](index=1&type=section&id=2023%20Business%20Highlights) Forte Biosciences advanced its lead product candidate, FB-102, into clinical trials, completing the SAD portion and initiating MAD cohorts - The primary achievement in 2023 was the clinical advancement of **FB-102**, a program targeting autoimmune diseases[2](index=2&type=chunk) - The Phase 1 trial for FB-102 successfully completed its single ascending dose (SAD) portion and has now commenced the multiple ascending dose (MAD) phase[2](index=2&type=chunk) [2023 Financial Performance](index=1&type=section&id=2023%20Financial%20Performance) Forte Biosciences' 2023 financial results show increased operating expenses, primarily from R&D for FB-102, resulting in a larger net loss and reduced cash reserves [Operating Results Summary](index=1&type=section&id=2023%20Operating%20Results) Research and development expenses significantly increased in 2023 due to FB-102, leading to a wider net loss per share Operating Expenses Comparison (2023 vs 2022) | Expense Category | 2023 (in millions) | 2022 (in millions) | Change (in millions) | | :--- | :--- | :--- | :--- | | Research and Development | $21.9 | $5.6 | +$16.3 | | General and Administrative | $10.6 | $8.3 | +$2.3 | Key Financial Metrics (as of Dec 31, 2023) | Metric | 2023 | 2022 | | :--- | :--- | :--- | | Net Loss per Share | ($1.00) | ($0.80) | | Cash and Cash Equivalents | $37.1 million | $41.1 million | | Common Stock Outstanding | 36.3 million shares | 21.0 million shares | [Consolidated Balance Sheets](index=2&type=section&id=CONSOLIDATED%20BALANCE%20SHEETS) Total assets decreased in 2023 primarily due to reduced cash, while liabilities slightly increased and stockholders' equity declined Balance Sheet Summary (in thousands) | Account | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $37,125 | $41,100 | | Total current assets | $38,327 | $41,511 | | **Total assets** | **$38,980** | **$41,997** | | **Liabilities & Equity** | | | | Total current liabilities | $3,666 | $3,179 | | Total stockholders' equity | $35,314 | $38,818 | | **Total liabilities and stockholders' equity** | **$38,980** | **$41,997** | [Consolidated Statements of Operations](index=2&type=section&id=CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20LOSS) The company reported a significantly increased net loss in 2023, driven by more than doubled total operating expenses due to intensified R&D Statement of Operations Summary (in thousands) | Line Item | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Research and development | $21,862 | $5,594 | | General and administrative | $10,624 | $8,302 | | **Total operating expenses** | **$32,486** | **$13,896** | | Loss from operations | ($32,486) | ($13,896) | | **Net loss** | **($31,476)** | **($13,879)** | | Net loss per share | ($1.00) | ($0.80) | [Corporate Overview and Forward-Looking Statements](index=3&type=section&id=About%20Forte) Forte Biosciences, a clinical-stage biopharmaceutical company, is developing FB-102 for autoimmune diseases, while cautioning on risks related to funding, clinical development, and regulatory approval - Forte is a clinical-stage biopharmaceutical company advancing its main product candidate, **FB-102**[11](index=11&type=chunk) - **FB-102** is being developed for broad autoimmune applications, with potential indications in graft-versus-host disease, vitiligo, and alopecia areata[11](index=11&type=chunk) - The company highlights risks related to its ability to obtain sufficient capital, clinical development uncertainties, and regulatory approval for **FB-102**[12](index=12&type=chunk)
Forte Biosciences(FBRX) - 2023 Q3 - Quarterly Report
2023-11-12 16:00
```markdown PART I. FINANCIAL INFORMATION [Financial Statements](index=2&type=section&id=Item%201.%20Financial%20Statements) Q3 2023 financials show increased operating expenses and net loss from FB-102 R&D, with cash boosted by July 2023 financing Condensed Consolidated Balance Sheet Data (in thousands) | Account | September 30, 2023 (unaudited) | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $46,185 | $41,100 | | Total current assets | $47,102 | $41,511 | | Total assets | $47,879 | $41,997 | | **Liabilities & Stockholders' Equity** | | | | Accounts payable | $5,354 | $1,153 | | Total current liabilities | $7,471 | $3,179 | | Accumulated deficit | $(112,648) | $(87,044) | | Total stockholders' equity | $40,408 | $38,818 | Condensed Consolidated Statements of Operations Data (in thousands) | Metric | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $6,369 | $1,379 | $18,295 | $3,106 | | General and administrative | $3,847 | $2,044 | $7,810 | $5,851 | | Loss from operations | $(10,216) | $(3,423) | $(26,105) | $(8,957) | | Net loss | $(9,955) | $(3,400) | $(25,604) | $(9,002) | | Net loss per share | $(0.26) | $(0.18) | $(0.96) | $(0.56) | Condensed Consolidated Statements of Cash Flows Data (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(19,737) | $(5,292) | | Net cash provided by investing activities | $63 | $0 | | Net cash provided by financing activities | $24,759 | $7,296 | | **Net increase in cash and cash equivalents** | **$5,085** | **$2,004** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the FB-102 program, increased R&D and G&A expenses, and a $25M private placement for future operations [Overview](index=19&type=section&id=Overview) Forte Biosciences advances preclinical FB-102 for autoimmune diseases, with **$46.2M** cash as of Sep 2023, boosted by a **$25M** private placement - The company is advancing its product candidate, **FB-102**, a proprietary molecule with potential applications in autoimmune diseases such as graft-versus-host disease (GvHD), vitiligo, and alopecia areata (AA)[101](index=101&type=chunk) - In July 2023, the company raised approximately **$25 million** in gross proceeds through a private placement of common stock and pre-funded warrants[109](index=109&type=chunk) - The company's ability to raise capital through its "at-the-market" (ATM) facility is currently restricted because the market value of its common stock held by non-affiliates is below the **$75 million** threshold required by Form S-3[110](index=110&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) Operating expenses significantly increased in Q3 2023 due to FB-102 R&D and litigation, resulting in a **$25.6M** net loss for the nine months Comparison of Operating Results (in thousands) | Expense Category | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | Change | | :--- | :--- | :--- | :--- | | Research and development | $18,295 | $3,106 | $15,189 | | General and administrative | $7,810 | $5,851 | $1,959 | | **Total operating expenses** | **$26,105** | **$8,957** | **$17,148** | | **Net Loss** | **$(25,604)** | **$(9,002)** | **$(16,602)** | - The increase in R&D expenses for the nine months ended Sep 30, 2023 was primarily due to a **$9.1 million** increase in manufacturing costs and a **$5.5 million** increase in preclinical expenses for the **FB-102** program[124](index=124&type=chunk) - The increase in G&A expenses for the nine months ended Sep 30, 2023 was mainly due to a **$1.9 million** increase in legal expenses, which includes litigation costs[127](index=127&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) As of Sep 2023, the company had **$46.2M** cash, sufficient for 12 months, with **$19.7M** net cash used in operations and **$24.8M** from financing - The company had cash and cash equivalents of approximately **$46.2 million** as of September 30, 2023, and believes this is sufficient to fund operations for at least 12 months from the filing date[130](index=130&type=chunk) - On July 31, 2023, the company raised gross proceeds of approximately **$25 million** from a private placement of common stock and pre-funded warrants[133](index=133&type=chunk) - Net cash used in operating activities increased to **$19.7 million** for the nine months ended September 30, 2023, from **$5.3 million** in the same period of 2022, primarily due to a higher net loss[139](index=139&type=chunk)[141](index=141&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Forte Biosciences is not required to provide market risk disclosures - As a smaller reporting company, Forte Biosciences is not required to provide quantitative and qualitative disclosures about market risk[149](index=149&type=chunk) [Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were ineffective due to a material weakness in income tax provision review, with remediation steps underway - The Chief Executive Officer and Chief Financial Officer concluded that disclosure controls and procedures were not effective due to a material weakness in internal control over the review of the annual income tax provision[150](index=150&type=chunk) - The company is taking steps to remediate the material weakness, including augmenting third-party resources for tax accounting review and strengthening its internal review process[152](index=152&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in multiple legal proceedings with Camac Fund LP, including books and records actions and fiduciary duty claims - Camac Fund LP has filed a books and records action against the company in the Delaware Court of Chancery, which remains pending[155](index=155&type=chunk) - Camac Fund LP filed a complaint against the company's directors, alleging breaches of fiduciary duty related to the July 2023 private placement and the timing of the 2023 annual meeting[156](index=156&type=chunk)[159](index=159&type=chunk) - On October 28, 2023, Forte filed a complaint against Camac and other defendants, alleging they issued false and misleading proxy statements and failed to disclose they were acting as a group, in violation of Exchange Act Sections 14(a) and 13(d)[162](index=162&type=chunk)[163](index=163&type=chunk) [Risk Factors](index=28&type=page&id=Item%201A.%20Risk%20Factors) The company faces substantial risks, primarily from its single preclinical product FB-102, requiring significant capital, and ongoing litigation and control weaknesses [Risks related to Forte's business, technology and industry](index=30&type=section&id=Risks%20related%20to%20Forte%27s%20business%2C%20technology%20and%20industry) The company's success depends on preclinical FB-102, has incurred **$112.6M** accumulated deficit, and requires substantial additional capital for operations - The company's business is almost entirely dependent on the success of developing **FB-102**, which is currently in preclinical development, after discontinuing its prior candidate FB-401 in 2021[169](index=169&type=chunk)[170](index=170&type=chunk) - Forte has incurred net losses every year since inception, with an accumulated deficit of **$112.6 million** as of September 30, 2023, and expects to continue incurring significant losses[179](index=179&type=chunk) - The company will require additional capital to fund its operations beyond the next twelve months. Failure to obtain necessary financing will prevent the completion of development and commercialization of **FB-102**[183](index=183&type=chunk) [Risks related to Government Regulation](index=47&type=section&id=Risks%20related%20to%20government%20regulation) FB-102 development faces lengthy, expensive, and uncertain regulatory approval, with no guarantee of success or freedom from ongoing compliance obligations - **FB-102** requires significant additional preclinical and clinical development before seeking regulatory approval, and there is no guarantee of success[244](index=244&type=chunk) - The process of obtaining regulatory approvals is expensive, may take many years, and is highly uncertain. The FDA has substantial discretion and may require additional studies or reject the application[267](index=267&type=chunk) - Even if approved, the company will be subject to ongoing regulatory requirements for manufacturing (cGMP), labeling, promotion, and post-marketing studies, with potential for significant penalties for non-compliance[277](index=277&type=chunk)[279](index=279&type=chunk) [Risks related to Intellectual Property](index=57&type=section&id=Risks%20related%20to%20Forte%27s%20intellectual%20property) Success hinges on obtaining and maintaining patent protection for FB-102, facing challenges to validity and potential costly infringement litigation - The company's success depends on its ability to obtain and maintain patent protection for **FB-102**, but there is no assurance that patent applications will be granted or that they will provide meaningful protection[295](index=295&type=chunk) - The patent position of healthcare companies is highly uncertain, and any patents Forte obtains may be challenged, invalidated, or circumvented by competitors[299](index=299&type=chunk)[301](index=301&type=chunk) - The company may be subject to third-party claims of intellectual property infringement, which could prevent or delay the development and commercialization of its product candidates and lead to expensive litigation[333](index=333&type=chunk) [Risks related to Reliance on Third Parties](index=67&type=section&id=Risks%20related%20to%20Forte%27s%20reliance%20on%20third%20parties) Forte heavily relies on third parties for preclinical studies, clinical trials, and manufacturing, exposing it to risks of non-performance and delays - The company relies on third parties (CROs, medical institutions) to conduct its preclinical studies and planned clinical trials, which limits its control over the timing and execution of these activities[346](index=346&type=chunk) - Forte contracts with third-party manufacturers (CMOs) for its product candidates and does not have its own manufacturing capabilities. This reliance creates risks related to supply sufficiency, quality, cost, and regulatory compliance (cGMP)[352](index=352&type=chunk) - If third-party collaborators fail to perform their obligations, terminate agreements, or prioritize other projects, Forte's development programs could be delayed or halted, and its business could be adversely affected[356](index=356&type=chunk) [General Risks](index=71&type=section&id=General%20Risks) The company faces Nasdaq delisting risk, high stock price volatility, ongoing litigation, and a material weakness in internal financial controls - The company is currently non-compliant with **Nasdaq's** minimum **$1.00** bid price requirement, which could result in the delisting of its common stock if not resolved by the **March 12, 2024** deadline[361](index=361&type=chunk) - The company's stock price is highly volatile, influenced by clinical development news, financial results, and market conditions. The company is also facing litigation related to its recent private placement[365](index=365&type=chunk)[370](index=370&type=chunk) - A material weakness has been identified in the company's internal control over financial reporting related to the review of its annual income tax provision, which could impact the ability to report financial results accurately and timely[385](index=385&type=chunk)[386](index=386&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=77&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred beyond those previously disclosed in the August 1, 2023 Form 8-K - No unregistered sales of securities occurred other than those previously disclosed in the Form 8-K filed on August 1, 2023[393](index=393&type=chunk) [Defaults Upon Senior Securities](index=77&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) None - The company reports no defaults upon senior securities[394](index=394&type=chunk) [Mine Safety Disclosures](index=78&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) None - The company reports no mine safety disclosures[396](index=396&type=chunk) [Other Information](index=78&type=section&id=Item%205.%20Other%20Information) None - The company reports no other information for this item[397](index=397&type=chunk) [Exhibits](index=79&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including agreements for the recent private placement and officer certifications - Exhibits filed include the Securities Purchase Agreement and Registration Rights Agreement from the July 2023 financing, an amendment to the Preferred Stock Rights Agreement, and the Amended and Restated 2021 Equity Incentive Plan[398](index=398&type=chunk) ```