Live-News • Jul 12
FB102 Achieves Primary Endpoint in Vitiligo Trial With Durable Improvement at Forte Biosciences Forte Biosciences reported that FB102 met its primary endpoint in a small placebo-controlled vitiligo trial, with statistically significant improvement in facial Vitiligo Area Scoring Index by week 24 and benefits persisting off treatment through week 24.
Experts described the FB102 study as a success but highlighted the need for larger confirmatory trials to better quantify efficacy and fully characterize the safety profile.
Forte Biosciences’ share price is at $43.92, with the stock up 150.1% over the past 30 days, reflecting a sharp recent repricing around the company’s prospects.
The key question now is how future, larger FB102 studies read out, since the current data are early stage and come from a small sample, which can make the stock sensitive to any shift in efficacy or safety signals. New Risk • Jul 09
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 25% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (25% average weekly change). Earnings are forecast to decline by an average of 30% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (100% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$189m net loss in 3 years). Ankündigung • Jul 09
Forte Biosciences Announces Positive Results From FB102 Double-Blind Placebo-Controlled Phase 1b Study In Vitiligo Forte Biosciences, Inc. announced positive results from the FB102 double-blind placebo-controlled phase 1b study in vitiligo. FB102 achieved 29.6% mean FVASI improvement from baseline at week 24 (p-value = 0.020). Response to FB102 was observed early, with statistically significant improvements observed by the day 64 visit (p=0.023), continuing through week 24, after completion of the 12-week treatment period. FB102 achieved 43.2% mean FVASI improvement from baseline at week 24 (p-value = 0.006) in subjects with greater disease involvement having baseline FVASI =0.75 (approximately one-quarter of face depigmented), including: FVASI50 = 58.8%, FVASI75 = 23.5%. Responder endpoints in overall population achieved FVASI50 in 34.4% of FB102 treated subjects at week 24 with FVASI 75 achieved in 12.5% of FB102 treated subjects at week 24; this endpoint was impacted by one placebo FVASI75 responder, reinforcing the importance of randomized controlled studies and baseline severity when interpreting vitiligo responder endpoints. The majority of FB102 treated subjects continued to improve through week 24 after completion of the 12-week treatment period with an additional 8 percentage point FVASI improvement between week 12 and 24. Among FB102-treated subjects with baseline FVASI =0.75 the mean FVASI improvement increased an additional 14 percentage points between week 12 and 24. 84% (27/32) of FB102 treated subjects improved from baseline to week 24 following the 12-week treatment period and 0% (0/32) worsened. 27% (3/11) of placebo subjects worsened during the 24 week period. FB102 continues to demonstrate a strong safety profile and compared favorably to placebo with only mild to moderate AEs. These independent centrally-reviewed, placebo-controlled data demonstrate statistically significant FB102 mean FVASI improvements from baseline, with progressive improvement and a strong responder profile through week 24 after completion of the 12-week treatment period. The FB102 double-blind placebo-controlled phase 1b vitiligo study enrolled 43 subjects 3:1 randomized with 11 on placebo and 32 on FB102. Forte enrolled 2 FB102 treatment cohorts in the trial including the 3 mg/kg maintenance cohort previously disclosed. There were 15 on FB102 in Cohort A and 17 in Cohort B. The primary endpoint of the study was mean percent FVASI improvement from baseline assessed by central-review. The mean percent FVASI improvement from baseline in the ITT population was 29.6% for FB102 (n=32) compared to a mean deterioration of 16.2% for placebo (n=11), for a placebo-adjusted FB102 benefit of 45.8% (p=0.005). The group of 11 placebo subjects in the ITT population had one subject that was not part of the protocol-defined efficacy-evaluable population due to facial hair and that subject also experienced vitiligo progression during the study. The protocol defined efficacy-evaluable population excluded this one placebo subject (n=10) which also provides a more conservative assessment of the FB102 activity. In the protocol-defined efficacy evaluable population (FB102: 32, PBO:10), FB102 achieved 29.6% mean FVASI improvement from baseline at week 24 vs 7.9% on placebo for a placebo-adjusted FB102 benefit of 21.7% (p-value = 0.020). Response to FB102 was observed early, with statistically significant improvement observed by the day 64 visit (p=0.023), continuing through week 24, after completion of the 12-week treatment period. In Cohort A, FB102 achieved a 28.8% mean FVASI improvement from baseline at week 24 compared to 7.9% for placebo for a placebo-adjusted FB102 benefit of 20.9% (p-value = 0.04) while in Cohort B, FB102 achieved a 30.4% mean FVASI improvement from baseline at week 24 compared to 7.9% for placebo for a placebo-adjusted FB102 benefit of 22.5% (p-value = 0.027). In subjects with greater disease involvement having baseline FVASI =0.75 (approximately one-quarter of face depigmented), FB102 achieved 43.2% mean FVASI improvement from baseline at week 24 compared to 0.5% for placebo treated subjects for a placebo-adjusted FB102 benefit of 42.7% (p-value = 0.006) with 10 of 17 FB102 treated subjects achieving an FVASI50 (58.8%) and 4 of 17 achieving an FVASI75 (23.5%) compared to 0 of 4 achieving FVASI50 and FVASI 75 for placebo subjects (0%). In the protocol-defined efficacy evaluable population 11 of 32 FB102 treated subjects achieved FVASI50 (34.4%) with 4 of 32 FB102 treated subjects achieving an FVASI 75 (12.5%) compared to 1 of 10 placebo subjects achieving FVASI50/75; the placebo FVASI75 responder reinforces the importance of randomized controlled studies and baseline severity when interpreting vitiligo responder endpoints. FB102 treated subjects continued to improve through week 24 after completion of the 12-week treatment period with an additional 8 percentage point FVASI improvement between week 12 and 24. Among FB102-treated subjects with baseline FVASI =0.75 the mean FVASI improvement increased an additional 14 percentage points between week 12 and 24. 84% (27/32) FB102 treated subjects improved from baseline to week 24 following the 12-week treatment period and 0% (0/32) worsened. 27% (3/11) of placebo subject worsened during the 24 week period. All AEs were mild/moderate with FB102 comparing favorably to placebo, and taken together with the phase1b celiac study, FB102 continues to demonstrate a strong safety profile. Ankündigung • May 02
Forte Biosciences, Inc., Annual General Meeting, May 29, 2026 Forte Biosciences, Inc., Annual General Meeting, May 29, 2026. Ankündigung • Apr 10
Forte Biosciences, Inc. has completed a Follow-on Equity Offering in the amount of $150.000019 million. Forte Biosciences, Inc. has completed a Follow-on Equity Offering in the amount of $150.000019 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 5,709,936
Price\Range: $26.27
Discount Per Security: $1.5762 Ankündigung • Apr 09
Forte Biosciences, Inc. has filed a Follow-on Equity Offering. Forte Biosciences, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock Breakeven Date Change • Apr 02
No longer forecast to breakeven The 4 analysts covering Forte Biosciences no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$133.6m in 2026. New consensus forecast suggests the company will make a loss of US$119.0m in 2027. New Risk • Jan 13
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings are forecast to decline by an average of 30% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (179% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$161m net loss in 3 years). Recent Insider Transactions • Jan 04
Chief Financial Officer recently bought US$255k worth of stock On the 30th of December, Antony Riley bought around 10k shares on-market at roughly US$26.33 per share. This transaction amounted to 30% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Antony's only on-market trade for the last 12 months. Ankündigung • Sep 16
Forte Biosciences, Inc. Announces Presentation of Fb102 Celiac Disease Trial At Tampere Celiac Disease Symposium Forte Biosciences, Inc. announced additional details from the oral presentation "FB102 prevents histological damage and mitigates gluten challenge-induced symptoms in a celiac disease phase 1b study - Jason Tye-Din, Walter and Eliza Hall Institute; Royal Melbourne Hospital" at the Tampere Celiac Disease Symposium 2025 (Tampere, Finland) on September 12, 2025, further supporting the significant differentiation of FB102 in celiac disease. Highlights of the oral presentation include: FB102 demonstrated a decline in the TCR gd density from baseline of 1.5 compared to an increase of 3.9 for placebo (p=0.0007); TCR gd cells produce pro-inflammatory cytokines including IFN-g and TNF-a and upregulate activating receptors on epithelial cells triggering cytotoxic responses that directly kill the epithelial cells. Ki67-positive intraepithelial cell density increased from baseline by 8.6 on placebo compared to 2.5 on FB102 (p=0.0006); Ki67 is a marker of T cell proliferation (inflammation) on gluten exposure in celiac disease; NK cells declined by 95% following FB102 dosing; IL-15 upregulates activating receptors and confers resistance to activation-induced cell death and enhances T cell epithelial cytotoxicity in celiac disease; No statistically significant difference in Tregs between FB102 and placebo at any timepoint; Regulatory T cells (Tregs) help to modulate the immune response in autoimmune diseases like celiac disease. The phase 2 FB102 celiac disease trial is underway with topline data coming in 2026. The FB102 impact on the additional IEL subtypes in the phase 1b trial is extremely encouraging with respect to the additional therapeutic indications Forte is pursuing, including vitiligo and alopecia areata with data from both of these trials expected next year. In some cases, you can identify forward-looking statements by terms such as " may, "will," "should," "plan," "anticipate," "intend," target, project,contemplates," "bel believes,estimates," "predicts," "pot potential" or "continue" or the negatives of these terms or other similar statements are based on the Company's current beliefs and expectations. Forward-looking statements include statements regarding the Company's beliefs, goals, intentions and expectations regarding its product candidate, FB102 and the therapeutic and commercial market potential of FB102, expectations for patient enrollment and timing of clinical data readouts. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: risks related to Forte's ability to obtain sufficient additional capital to continue to advance Forte's product candidate, FB102; uncertainties associated with the clinical development and regulatory approval of Forte's product candidate,FB102, including potential delays in the commencement, enrollment and completion of clinical trials, including the timing of the completion of the Company's patient-based trials; the risk that results from preclinical and any interim result of ongoing clinical trials may not be predictive of future results from clinical trials may not be predictive the failure to realize any value from FB102 in light of inherent risks, expense and difficulties involved in successfully bringing product candidates to market; and additional risks, uncertainties, and other information affecting Forte's business and operating results is contained in Forte's quarterly Report on Forms 10-QQQQQQQ. Price Target Changed • Aug 18
Price target increased by 14% to US$52.25 Up from US$45.67, the current price target is an average from 4 analysts. New target price is 339% above last closing price of US$11.91. Stock is up 44% over the past year. The company is forecast to post a net loss per share of US$4.47 next year compared to a net loss per share of US$12.17 last year. Price Target Changed • Aug 17
Price target decreased by 8.2% to US$44.67 Down from US$48.67, the current price target is an average from 3 analysts. New target price is 286% above last closing price of US$11.57. Stock is up 54% over the past year. The company is forecast to post a net loss per share of US$4.52 next year compared to a net loss per share of US$12.17 last year. Ankündigung • Jun 24
Forte Biosciences, Inc. Announces Positive Data in Ff102 Celiac Disease Phase 1B Study Forte Biosciences, Inc. announced positive data from a Phase 1b trial in celiac disease for lead program FB102 (FB102-101). Treatment emergent adverse events (TEAE) were primarily mild (grade 1) with no grade 3 or higher SAEs reported in the FB102 arm. Celiac disease is debilitating for many patients with even trace exposure to gluten. FB102 has taken a big step forward towards addressing this very large unmet need with the results from this study. The Phase 2 celiac disease study is initiating with a topline readout expected in 2026. These results are also very encouraging given the biology of the additional FB102 indications including vitiligo, alopecia areata and type 1 diabetes. The company also look forward to reading out the topline results of the FB102 vitiligo study in the first half of 2026. New Risk • Jun 05
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$35m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$35m free cash flow). Share price has been highly volatile over the past 3 months (23% average weekly change). Shareholders have been substantially diluted in the past year (352% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (US$44m net loss next year). Market cap is less than US$100m (US$65.7m market cap). Ankündigung • Apr 21
Forte Biosciences, Inc., Annual General Meeting, May 29, 2025 Forte Biosciences, Inc., Annual General Meeting, May 29, 2025. Price Target Changed • Apr 04
Price target decreased by 45% to US$59.00 Down from US$107, the current price target is an average from 2 analysts. New target price is 903% above last closing price of US$5.88. Stock is down 66% over the past year. The company is forecast to post a net loss per share of US$3.73 next year compared to a net loss per share of US$12.17 last year. New Risk • Mar 24
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 18% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Earnings are forecast to decline by an average of 26% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (339% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$80m net loss in 3 years). Market cap is less than US$100m (US$52.2m market cap). New Risk • Jan 13
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 340% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (39% average weekly change). Earnings have declined by 3.9% per year over the past 5 years. Shareholders have been substantially diluted in the past year (340% increase in shares outstanding). Revenue is less than US$1m. Ankündigung • Nov 21
Forte Biosciences, Inc. announced that it expects to receive $53 million in funding from OrbiMed Advisors LLC, Janus Henderson Group plc, Tybourne Capital Management Limited, Ikarian Capital, LLC, BVF Partners L.P., Fred Alger Management, LLC Forte Biosciences, Inc. announced an private placement of common shares for gross proceeds of $53,000,000 on November 19, 2024. The transaction included participation from new and existing investors including OrbiMed Advisors LLC, Janus Henderson Group plc, Tybourne Capital Management Limited, Ikarian Capital, LLC, BVF Partners L.P., Red Hook Fund LP, Fred Alger Management, LLC. The Private Placement is expected to close on November 21, 2024. Board Change • Oct 01
High number of new directors There are 6 new directors who have joined the board in the last 3 years. Independent Director Rich Vincent was the last director to join the board, commencing their role in 2024. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Board Change • Sep 25
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Director Shivpreet Kapoor was the last director to join the board, commencing their role in 2024. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. New Risk • Sep 19
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.83m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$31m free cash flow). Earnings have declined by 2.4% per year over the past 5 years. Revenue is less than US$1m. Market cap is less than US$10m (US$9.83m market cap). Minor Risk Share price has been volatile over the past 3 months (14% average weekly change). New Risk • Aug 20
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 15% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$31m free cash flow). Share price has been highly volatile over the past 3 months (15% average weekly change). Earnings have declined by 2.4% per year over the past 5 years. Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (US$12.0m market cap). Price Target Changed • Aug 16
Price target increased by 25% to US$4.38 Up from US$3.50, the current price target is an average from 2 analysts. New target price is 1,358% above last closing price of US$0.30. Stock is down 64% over the past year. The company posted a net loss per share of US$1.00 last year. Ankündigung • Jul 22
Forte Biosciences, Inc., Annual General Meeting, Aug 20, 2024 Forte Biosciences, Inc., Annual General Meeting, Aug 20, 2024. New Risk • Jun 28
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 9.8% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$30m free cash flow). Shareholders have been substantially diluted in the past year (73% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (9.8% average weekly change). Market cap is less than US$100m (US$17.5m market cap). New Risk • May 15
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$30m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$30m free cash flow). Shareholders have been substantially diluted in the past year (73% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (US$24.7m market cap). New Risk • Nov 24
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$23m free cash flow). Earnings have declined by 4.6% per year over the past 5 years. Shareholders have been substantially diluted in the past year (73% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (10% average weekly change). Market cap is less than US$100m (US$15.6m market cap). New Risk • Nov 16
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$16m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$16m free cash flow). Earnings have declined by 4.6% per year over the past 5 years. Shareholders have been substantially diluted in the past year (73% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (US$14.2m market cap). Board Change • Oct 01
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Independent Director Mike Hacke was the last director to join the board, commencing their role in 2023. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Ankündigung • Sep 22
Forte Biosciences Receives Non-Compliance Letter from Nasdaq On September 14, 2023, Forte Biosciences, Inc. (the Company") received a written notice (the Notice") from the Nasdaq Listing Qualifications staff of The Nasdaq Stock Market LLC (Nasdaq") indicating that, for the last 30 consecutive business days, the minimum bid price of the Company's common stock had been below the $1.00 per share minimum requirement for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the Minimum Bid Price Requirement"). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided an initial period of 180 calendar days, or until March 12, 2024, to regain compliance with the Minimum Bid Price Requirement. The Notice states that the Nasdaq staff will provide written notification that the Company has achieved compliance with Rule 5550(a)(2) if, at any time before March 12, 2024, the closing bid price of the Company's common stock is $1.00 per share or more for a minimum of ten consecutive business days. The Notice has no immediate effect on the listing or trading of the Company's common stock. In the event the Company does not regain compliance with the Minimum Bid Price Requirement by March 12, 2024, the Company may be eligible for additional time to regain compliance. To qualify, the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. If the Company meets these requirements, the Company will be granted an additional 180 calendar days to regain compliance. If the Company does not qualify for or fails to regain compliance during the second compliance period, then the Nasdaq staff will provide written notification to the Company that its common stock will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. The Company intends to actively monitor the closing bid price of its common stock and consider its available options to regain compliance with the Minimum Bid Price Requirement. There can be no assurance that the Company will regain compliance with the Minimum Bid Price Requirement during the 180-day compliance period ending March 12, 2024, secure an extension of the compliance period beyond March 12, 2024 or maintain compliance with any other Nasdaq listing requirements. Ankündigung • Sep 21
Forte Biosciences, Inc. Announces Directorate Appointments Forte Biosciences, Inc. at its AGM held on September 19, 2023, approved appointment of Chris McIntyre and Michael G. Hacke as directors. Ankündigung • Sep 07
Camac Partners Shares Key Facts that Reinforce the Need for Urgent Change in Forte Biosciences’s Boardroom On September 6, 2023, Camac Partners, LLC and ATG Capital Management, LLC, the Group and its independent director candidates – Michael Hacke and Chris McIntyre – responded to misrepresentations and distortions included in Forte Biosciences, Inc’s recent presentation. Camac Partners stated that Hacke and McIntyre have been nominated by the Group for election to the Company’s Board of Directors at the upcoming Annual Meeting of Stockholders currently scheduled for September 19, 2023. Camac Partners stated that as a reminder, the Group recently filed its own presentation that details why it believes the Company is in urgent need of boardroom change following years of poor performance and worst-in-class governance under Chairman and CEO Paul Wagner. In addition, the Group encourages stockholders to consider the facts before deciding which individuals to support at the upcoming Annual Meeting. Ankündigung • Aug 26
Forte Biosciences, Inc., Annual General Meeting, Sep 19, 2023 Forte Biosciences, Inc., Annual General Meeting, Sep 19, 2023. New Risk • Aug 18
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 78% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 2.6% per year over the past 5 years. Shareholders have been substantially diluted in the past year (78% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (US$30.3m market cap). Ankündigung • Jan 13
Forte Biosciences, Inc appoints David Gryska to the Board of Directors Forte Biosciences, Inc. announced that Mr. David Gryska has been appointed to the Forte Biosciences Board of Directors. Mr. Gryska was previously the Chief Financial Officer and Executive Vice President at Incyte. Prior to joining Incyte, Mr. Gryska held the position of Chief Financial Officer and Senior Vice President at Celgene prior to its acquisition by Bristol-Myers Squibb. Mr. Gryska has spent over 30 years as a senior executive at life science and biotechnology companies with extensive experience relating to strategic transactions, acquisitions, financings and global expansion. Recent Insider Transactions • Dec 20
CEO & Chairman recently bought US$105k worth of stock On the 16th of December, Paul A. Wagner bought around 100k shares on-market at roughly US$1.05 per share. This transaction amounted to 7.8% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Paul A.'s only on-market trade for the last 12 months. Board Change • Nov 16
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 2 experienced directors. No highly experienced directors. CEO & Chairman Paul A. Wagner is the most experienced director on the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Seeking Alpha • Aug 16
Forte Biosciences: Lots Of Clinical Risk Ahead And A Questionable Business Plan FB-401, the lead asset failed in clinical trials.
The company has one very early-stage asset they intend to move forward in the clinic, FB-102.
Investors are likely to encounter dilution, a high degree of clinical risk and there is insufficient evidence to assess whether FB-401 has any advantages over other therapeutics.
Summary
Creativity is not my strength so I am reusing the title from an article that I wrote a few months back about Vyne Therapeutics, another dermatology company. The shares of Vyne have fallen 60% since then. The story is at Forte is essentially the same and all too common in biotech. Vyne and Forte both experienced setbacks, institutional investors sold and long term investors have fared poorly. Most importantly, for both companies, there is a suboptimal plan to move forward that exposes investors to a high degree of clinical risk, requires hundreds of millions of capital and has a low chance of rewarding investors in a manner commensurate with this outsized risk. I will outline a few reasons I rate Forte Biosciences (FBRX) a SELL
Institutional Investors
Major institutional investors have sold and cut their losses. Forte Biosciences had an enviable roster of professional investors including BVF, Orbimed and Perceptive Advisors. These are seasoned investors with a staff of PhD/MDs who are highly capable of assessing the future likelihood of success. All three funds sold their entire stake in the company. This is not always the case after a clinical failure. There are many cases where institutional investors increase their stake at a low price. Three institutional investors selling their entire stake strongly suggests these professionals do not see a bright future.
For an unprofitable biotech company, institutional investors are an important source of capital. Funding an unprofitable biotech in the capital markets is very challenging currently. It is not clear Forte will be able to obtain future funding and if they do, terms will likely be unfavorable. What is clear is they have very limited cash ($38.5 m currently) and they will need hundreds of million to develop the new molecule. In fact, they have a shelf registration in place. Investors should expect substantial dilution.
The Plan Forward
The asset the company intends to move forward after the failure of FB-401 in atopic dermatitis is FB-102. Given this asset is in the very early stages of testing, prudence dictates an assessment as to whether the risk is worth the potential reward. This molecule may enter the clinic for testing as late as 2024.
The company's presentation noted development plans in graft versus host disease (GvHD), vitiligo and alopecia areata which represent combined markets of over $6 billion. Each indication will require separate clinical trials to prove safety and efficacy adding substantially to the cost of development. Each of these indications has standard of care treatments.
The company notes an unmet medical need. GvHD is a disease where there is a legitimate unmet need but there are other companies much further along in testing including Seres Therapeutics (MCRB) and MaaT Pharma. The unmet need may be satisfied by these entrants and MaaT has already produced favorable safety and efficacy data.
Alopecia and vitiligo have very effective treatments currently-JAK inhibitors. The company noted the safety profile of JAK inhibitors. Opzelura is a topical JAK and most Doctors consider the safety profile of the cream to be of no concern whatsoever. In alopecia, where oral JAKS are approved, the safety and efficacy data for all 3 JAK inhibitors (Pfizer, Lilly and Concert) has been favorable but there is a black box warning. From an efficacy standpoint, there is no unmet need. From a safety standpoint, the mechanism of action and side effect profile are related. The JAK inhibitors work in vitiligo and alopecia areata by suppressing the immune system. There is nothing to suggest FB-102 can achieve the suppression of the immune system required for efficacy without the same safety issues.
Investors are going to spend hundreds of million dollars developing treatments in indications where there are either treatments approved or assets years ahead of Forte's molecule, FB-102. Investors are taking on a huge amount of risk to enter crowded markets with little assurance of any competitive advantage. Of course, there is also the possibility the molecule does not show efficacy or adequate safety and needs to abandoned leaving Forte with no assets.
To make development of FB-102 worthwhile, it would have to offer a benefit over existing treatments. The company presentation does not include the mechanism of action of FB-102 making it impossible to ascertain whether the "proprietary molecule" that involves "antagonism of a pathway for autoimmune disease" has any advantages or is even likely to work.
The company cites infrequent dosing as a potential benefit of the treatment. This is an extraordinarily poor reason to spend hundreds of millions to develop a treatment. Dosing is a very unimportant issue in diseases such as GvHD which can be fatal. Vitiligo and alopecia areata are diseases where patients have skin discolorations or baldness and patients are highly motivated to take their medicine. Seeking Alpha • Jul 07
Forte Biosciences large shareholders make demands for company's future A pair of large shareholders of Forte Biosciences (NASDAQ:FBRX) are making demands that could impact the company's future, including the suggestion that the company liquidate.
In a Wednesday SEC filing, Brad Leonard, managing member of BML Capital Management, which has a 9.1% stake in common shares, wrote that "Forte shareholders would be best served by a complete liquidation as soon as possible."
Forte (FBRX) and some shareholders have been at odds over the future of Forte's only asset, FB-102, which is in the preclinical stage for several indications, including alopecia and vitiligo, a conditions that affects skin pigmentation.
Leonard noted that since a May announcement on development plans, there has not been a single insider purchase.
On Tuesday, Jacob Ma-Weaver, managing member of Funicular Funds, said in a SEC filing that Forte's board had yet to make an "adequate assessment of the potential immediate value creation that could be achieved through a substantial buyback program, tender offer at a premium, or special dividend." Funicular has a 7.5% stake.
Seeking Alpha's Quant Rating views Forte (FBRX) as a hold with the only high grade being for valuation. Board Change • Apr 27
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 1 experienced director. No highly experienced directors. President, CEO & Chairman Paul A. Wagner is the most experienced director on the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Board Change • Apr 02
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 1 experienced director. No highly experienced directors. President, CEO & Chairman Paul A. Wagner is the most experienced director on the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Board Change • Dec 05
High number of new and inexperienced directors There are 4 new directors who have joined the board in the last 3 years. The company's board is composed of: 4 new directors. 1 experienced director. No highly experienced directors. President, CEO & Chairman Paul A. Wagner is the most experienced director on the board, commencing their role in 2017. The company’s lack of experienced directors is considered a risk according to the Simply Wall St Risk Model. Recent Insider Transactions • Sep 09
President recently sold US$4.3m worth of stock On the 7th of September, Paul A. Wagner sold around 1m shares on-market at roughly US$4.35 per share. This was the largest sale by an insider in the last 3 months. This was Paul A.'s only on-market trade for the last 12 months. Price Target Changed • Sep 04
Price target increased to US$103 Up from US$88.20, the current price target is an average from 5 analysts. New target price is 1,936% above last closing price of US$5.06. Stock is down 81% over the past year. Executive Departure • Jun 04
Director Thomas Darcy has left the company On the 28th of May, Thomas Darcy's tenure as Director ended after 13.8 years in the role. As of March 2021, Thomas still personally held 25.14k shares (US$861k worth at the time). Thomas is the only executive to leave the company over the last 12 months. The current median tenure of the management team is less than a year, which is considered inexperienced in the Simply Wall St Risk Model. Breakeven Date Change • May 22
Forecast to breakeven in 2025 The 5 analysts covering Forte Biosciences expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$49.1m in 2025. Average annual earnings growth of 44% is required to achieve expected profit on schedule. Is New 90 Day High Low • Feb 19
New 90-day low: US$30.76 The company is down 24% from its price of US$40.27 on 20 November 2020. The American market is up 10.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 15% over the same period. Is New 90 Day High Low • Jan 28
New 90-day low: US$33.73 The company is down 7.0% from its price of US$36.38 on 29 October 2020. The American market is up 21% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 28% over the same period. Is New 90 Day High Low • Sep 29
New 90-day high: US$50.69 The company is up 232% from its price of US$15.25 on 01 July 2020. The American market is up 8.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 4.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share.