Latest news with #ForteBiosciences
Business Wire
8 hours ago
- Business
- Business Wire
Forte Biosciences Announces Positive Data in FB102 Celiac Disease Phase 1B Study
DALLAS--(BUSINESS WIRE)--Forte Biosciences, Inc. ( (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced positive data from a Phase 1b trial in celiac disease for lead program FB102 (FB102-101). The company will be hosting a conference call today at 8:30 am ET. Prof. Jason Tye-Din, Head of Celiac Research at the Walter and Eliza Hall Institute and principal investigator in the FB102-101 study will be participating in the call. Please connect to the call using the following link: The event and accompanying slides can also be accessed by visiting the investor relations section of the company's website at An archived webcast will be available on the company's website following the event. The FB102-101 Phase 1b celiac disease study enrolled 32 subjects 3:1 randomized (24 on FB102 and 8 on placebo). Subjects received 4 doses of FB102 (10 mg/kg) and underwent a 16 day gluten challenge. In addition to safety and tolerability, the study assessed morphologic and inflammatory endpoints along with gluten challenge (GC) induced symptoms. FB102 demonstrated a statistically significant benefit on the composite histological VCIEL endpoint (change from baseline). The mean VCIEL change from baseline was -1.849 for placebo subjects compared to 0.079 for FB102 treated subjects (p=0.0099). The change in the density of CD3-positive T cells, or IELs, from baseline was an increase of 13.3 for placebo subjects compared to a decline of 1.5 for FB102 treated subjects (p=0.0035). Baseline IEL density was 25.6 for the placebo subjects and 23.5 for the FB102 treated subjects. The mean change in the Vh:Cd ratio from baseline was -0.173 (0.21) for placebo subjects compared to -0.046 (0.09), a 73% improvement for FB102 treated subjects compared to placebo. Gluten challenge induced GI symptoms (nausea, vomiting, diarrhea, abdominal pain and abdominal bloating) reported during the 16 day gluten challenge from patient diaries/AE collection demonstrated a 42% benefit for FB102 treated subject (4.0 events per subject) compared to placebo (6.9 events per subject). There were no dropouts in the study. Treatment emergent adverse events (TEAE) were primarily mild (grade 1) with no grade 3 or higher SAEs reported in the FB102 arm. 'We want to congratulate all of the investigators and researchers that supported this study. I also want to acknowledge the incredible dedication and hard work of the Forte team. 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.' said Paul Wagner, Ph.D. CEO and Chairperson of Forte Biosciences. 'These results are also very encouraging given the biology of the additional FB102 indications including vitiligo, alopecia areata and type 1 diabetes. We also look forward to reading out the topline results of the FB102 vitiligo study in the first half of 2026.' About Forte Forte Biosciences, Inc. is a clinical-stage biopharmaceutical company that is advancing FB102, which is a proprietary anti-CD122 monoclonal antibody therapeutic candidate with potentially broad autoimmune and autoimmune-related indications. Forward-Looking Statements Forte cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as 'may,' 'will,' 'should,' 'expect,' 'plan,' 'anticipate,' 'could,' 'intend,' 'target,' 'project,' 'contemplates,' 'believes,' 'estimates,' 'predicts,' 'potential' or 'continue' or the negatives of these terms or other similar expressions. These statements are based on the Forte's current beliefs and expectations. Forward-looking statements include statements regarding Forte's beliefs, goals, intentions and expectations regarding its product candidate, FB102 and the therapeutic and commercial market potential of FB102, the expected timeline for the Phase 2 celiac study and related readout, and the expected timing of topline results for the FB102 vitiligo study. 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; the risk that results from preclinical and the Phase 1b trials may not be predictive of future results from clinical trials; risks associated with 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-Q filed on May 15, 2025, and in its other filings with the Securities and Exchange Commission. All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Forte undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Source: Forte Biosciences, Inc.
Yahoo
15-05-2025
- Business
- Yahoo
Forte Biosciences, Inc. Announces Results and Provides Update
DALLAS, May 15, 2025--(BUSINESS WIRE)--Forte Biosciences, Inc. ( (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced its first quarter 2025 financial results and provided a clinical update. "We are looking forward to reading out the topline data from the FB102 celiac disease trial this quarter. FB102 continues to be well-tolerated and there have been no dropouts to date. Additionally, we have now dosed the first patient in the FB102 vitiligo trial. 2025 is shaping up to be a very eventful year which we believe will further validate the potential for FB102," said Forte Biosciences CEO Paul Wagner, Ph.D. Q1 2025 Operating Results Research and development expenses were $12.7 million for the three months ended March 31, 2025, compared to $4.4 million for the same period in 2024. The increase was primarily due to an increase of $8.9 million in manufacturing expenses to support our two clinical trials and clinical expenses for celiac disease and vitiligo indications, partially offset by a decrease of $0.5 million in personnel-related expenses. General and administrative expenses were $3.4 million for the three months ended March 31, 2025 compared to $3.5 million for the same period in 2024. The decrease was primarily due to decreases in legal and professional expenses of $1.0 million offset by an increase of $0.9 million in personnel related expenses including additional non-cash stock-based compensation of $0.7 million. Net losses per share were $(1.37) and $(4.03) for the quarters ended March 31, 2025 and 2024, respectively. Forte ended the first quarter of 2025 with $45.9 million in cash and cash equivalents. There are 6.6 million shares of common stock and 4.8 million prefunded warrants outstanding as of March 31, 2025. FORTE BIOSCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share and par value data) March 31, 2025 December 31, 2024 (unaudited) Assets Current assets: Cash and cash equivalents $ 45,856 $ 22,244 Short-term investments — 36,121 Prepaid expenses and other current assets 1,302 2,981 Total current assets 47,158 61,346 Property and equipment, net 125 77 Other assets 176 138 Total assets $ 47,459 $ 61,561 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 5,023 $ 4,879 Accrued liabilities (including $50 and $0 related party payable as of March 31, 2025 and December 31, 2024, respectively) 4,009 4,202 Total current liabilities 9,032 9,081 Commitments and contingencies (Note 6) Stockholders' equity: Common stock, $0.001 par value: 200,000,000 shares authorized as of March 31, 2025 (unaudited) and December 31, 2024; 6,581,667 and 6,393,323 shares issued and outstanding as of March 31, 2025 (unaudited) and December 31, 2024, respectively 6 6 Additional paid-in capital 208,075 206,461 Accumulated other comprehensive income — 11 Accumulated deficit (169,654 ) (153,998 ) Total stockholders' equity 38,427 52,480 Total liabilities and stockholders' equity $ 47,459 $ 61,561 FORTE BIOSCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) (in thousands, except share and per share amounts) For the Three Months Ended March 31, 2025 2024 Operating expenses: Research and development $ 12,542 $ 4,324 Research and development - related party 150 29 General and administrative 3,432 3,451 Total operating expenses 16,124 7,804 Loss from operations (16,124 ) (7,804 ) Other income, net 468 384 Net loss $ (15,656 ) $ (7,420 ) Per share information: Net loss per share - basic and diluted $ (1.37 ) $ (4.03 ) Weighted average shares and pre-funded warrants outstanding, basic and diluted 11,398,971 1,843,306 Comprehensive Loss: Net loss $ (15,656 ) $ (7,420 ) Unrealized loss on available-for-sale securities, net (11 ) (6 ) Comprehensive loss $ (15,667 ) $ (7,426 ) Additional details on Forte's first quarter 2025 financial results can be found in Forte's Form 10-Q as filed with the SEC on May 15, 2025. You can also find more information in the investor relations section of Forte's website at About Forte Forte Biosciences, Inc. is a clinical-stage biopharmaceutical company that is advancing FB102, which is a proprietary anti-CD122 monoclonal antibody therapeutic candidate with potentially broad autoimmune and autoimmune-related indications. Forward-Looking Statements Forte cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negatives of these terms or other similar expressions. These 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 our ongoing clinical trials may not be predictive of future results from clinical trials; risks associated with 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-Q filed on May 15, 2025, and in its other filings with the Securities and Exchange Commission. All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Forte undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Source: Forte Biosciences, Inc. View source version on Contacts LifeSci AdvisorsMike Moyer, Managing Directormmoyer@ Forte Biosciences, Wagner, CEOinvestors@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
15-05-2025
- Business
- Business Wire
Forte Biosciences, Inc. Announces Results and Provides Update
DALLAS--(BUSINESS WIRE)--Forte Biosciences, Inc. ( (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced its first quarter 2025 financial results and provided a clinical update. 'We are looking forward to reading out the topline data from the FB102 celiac disease trial this quarter. FB102 continues to be well-tolerated and there have been no dropouts to date. Additionally, we have now dosed the first patient in the FB102 vitiligo trial. 2025 is shaping up to be a very eventful year which we believe will further validate the potential for FB102,' said Forte Biosciences CEO Paul Wagner, Ph.D. Q1 2025 Operating Results Research and development expenses were $12.7 million for the three months ended March 31, 2025, compared to $4.4 million for the same period in 2024. The increase was primarily due to an increase of $8.9 million in manufacturing expenses to support our two clinical trials and clinical expenses for celiac disease and vitiligo indications, partially offset by a decrease of $0.5 million in personnel-related expenses. General and administrative expenses were $3.4 million for the three months ended March 31, 2025 compared to $3.5 million for the same period in 2024. The decrease was primarily due to decreases in legal and professional expenses of $1.0 million offset by an increase of $0.9 million in personnel related expenses including additional non-cash stock-based compensation of $0.7 million. Net losses per share were $(1.37) and $(4.03) for the quarters ended March 31, 2025 and 2024, respectively. Forte ended the first quarter of 2025 with $45.9 million in cash and cash equivalents. There are 6.6 million shares of common stock and 4.8 million prefunded warrants outstanding as of March 31, 2025. (in thousands, except share and par value data) March 31, 2025 (unaudited) Assets Current assets: Cash and cash equivalents $ 45,856 $ 22,244 Short-term investments — 36,121 Prepaid expenses and other current assets 1,302 2,981 Total current assets 47,158 61,346 Property and equipment, net 125 77 Other assets 176 138 Total assets $ 47,459 $ 61,561 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 5,023 $ 4,879 Accrued liabilities (including $50 and $0 related party payable as of March 31, 2025 and December 31, 2024, respectively) 4,009 4,202 Total current liabilities 9,032 9,081 Commitments and contingencies (Note 6) Stockholders' equity: Common stock, $0.001 par value: 200,000,000 shares authorized as of March 31, 2025 (unaudited) and December 31, 2024; 6,581,667 and 6,393,323 shares issued and outstanding as of March 31, 2025 (unaudited) and December 31, 2024, respectively 6 6 Additional paid-in capital 208,075 206,461 Accumulated other comprehensive income — 11 Accumulated deficit (169,654 ) (153,998 ) Total stockholders' equity 38,427 52,480 Total liabilities and stockholders' equity $ 47,459 $ 61,561 Expand FORTE BIOSCIENCES, INC. (unaudited) (in thousands, except share and per share amounts) For the Three Months Ended March 31, 2025 2024 Operating expenses: Research and development $ 12,542 $ 4,324 Research and development - related party 150 29 General and administrative 3,432 3,451 Total operating expenses 16,124 7,804 Loss from operations (16,124 ) (7,804 ) Other income, net 468 384 Net loss $ (15,656 ) $ (7,420 ) Per share information: Net loss per share - basic and diluted $ (1.37 ) $ (4.03 ) Weighted average shares and pre-funded warrants outstanding, basic and diluted 11,398,971 1,843,306 Comprehensive Loss: Net loss $ (15,656 ) $ (7,420 ) Unrealized loss on available-for-sale securities, net (11 ) (6 ) Comprehensive loss $ (15,667 ) $ (7,426 ) Expand Additional details on Forte's first quarter 2025 financial results can be found in Forte's Form 10-Q as filed with the SEC on May 15, 2025. You can also find more information in the investor relations section of Forte's website at About Forte Forte Biosciences, Inc. is a clinical-stage biopharmaceutical company that is advancing FB102, which is a proprietary anti-CD122 monoclonal antibody therapeutic candidate with potentially broad autoimmune and autoimmune-related indications. Forward-Looking Statements Forte cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as 'may,' 'will,' 'should,' 'expect,' 'plan,' 'anticipate,' 'could,' 'intend,' 'target,' 'project,' 'contemplates,' 'believes,' 'estimates,' 'predicts,' 'potential' or 'continue' or the negatives of these terms or other similar expressions. These 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 our ongoing clinical trials may not be predictive of future results from clinical trials; risks associated with 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-Q filed on May 15, 2025, and in its other filings with the Securities and Exchange Commission. All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Forte undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Source: Forte Biosciences, Inc.
Yahoo
01-04-2025
- Business
- Yahoo
Is Forte Biosciences (NASDAQ:FBRX) In A Good Position To Deliver On Growth Plans?
There's no doubt that money can be made by owning shares of unprofitable businesses. For example, although made losses for many years after listing, if you had bought and held the shares since 1999, you would have made a fortune. But while history lauds those rare successes, those that fail are often forgotten; who remembers So, the natural question for Forte Biosciences (NASDAQ:FBRX) shareholders is whether they should be concerned by its rate of cash burn. For the purpose of this article, we'll define cash burn as the amount of cash the company is spending each year to fund its growth (also called its negative free cash flow). First, we'll determine its cash runway by comparing its cash burn with its cash reserves. We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. A company's cash runway is calculated by dividing its cash hoard by its cash burn. When Forte Biosciences last reported its December 2024 balance sheet in March 2025, it had zero debt and cash worth US$58m. Looking at the last year, the company burnt through US$31m. So it had a cash runway of approximately 23 months from December 2024. That's not too bad, but it's fair to say the end of the cash runway is in sight, unless cash burn reduces drastically. Depicted below, you can see how its cash holdings have changed over time. Check out our latest analysis for Forte Biosciences Forte Biosciences didn't record any revenue over the last year, indicating that it's an early stage company still developing its business. Nonetheless, we can still examine its cash burn trajectory as part of our assessment of its cash burn situation. Over the last year its cash burn actually increased by 6.9%, which suggests that management are increasing investment in future growth, but not too quickly. That's not necessarily a bad thing, but investors should be mindful of the fact that will shorten the cash runway. While the past is always worth studying, it is the future that matters most of all. For that reason, it makes a lot of sense to take a look at our analyst forecasts for the company. While its cash burn is only increasing slightly, Forte Biosciences shareholders should still consider the potential need for further cash, down the track. Issuing new shares, or taking on debt, are the most common ways for a listed company to raise more money for its business. Many companies end up issuing new shares to fund future growth. By comparing a company's annual cash burn to its total market capitalisation, we can estimate roughly how many shares it would have to issue in order to run the company for another year (at the same burn rate). Forte Biosciences' cash burn of US$31m is about 59% of its US$52m market capitalisation. From this perspective, it seems that the company spent a huge amount relative to its market value, and we'd be very wary of a painful capital raising. Even though its cash burn relative to its market cap makes us a little nervous, we are compelled to mention that we thought Forte Biosciences' cash runway was relatively promising. We don't think its cash burn is particularly problematic, but after considering the range of factors in this article, we do think shareholders should be monitoring how it changes over time. On another note, Forte Biosciences has 5 warning signs (and 4 which are significant) we think you should know about. If you would prefer to check out another company with better fundamentals, then do not miss this free list of interesting companies, that have HIGH return on equity and low debt or this list of stocks which are all forecast to grow. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Sign in to access your portfolio
Yahoo
19-02-2025
- Business
- Yahoo
One Forte Biosciences Insider Raised Stake By 273% In Previous Year
Looking at Forte Biosciences, Inc.'s (NASDAQ:FBRX ) insider transactions over the last year, we can see that insiders were net buyers. That is, there were more number of shares purchased by insiders than there were sold. While insider transactions are not the most important thing when it comes to long-term investing, we do think it is perfectly logical to keep tabs on what insiders are doing. Check out our latest analysis for Forte Biosciences In the last twelve months, the biggest single purchase by an insider was when Chief Financial Officer Antony Riley bought US$125k worth of shares at a price of US$5.55 per share. Although we like to see insider buying, we note that this large purchase was at significantly below the recent price of US$11.23. Because the shares were purchased at a lower price, this particular buy doesn't tell us much about how insiders feel about the current share price. The chart below shows insider transactions (by companies and individuals) over the last year. If you click on the chart, you can see all the individual transactions, including the share price, individual, and the date! There are always plenty of stocks that insiders are buying. If investing in lesser known companies is your style, you could take a look at this free list of companies. (Hint: insiders have been buying them). Looking at the total insider shareholdings in a company can help to inform your view of whether they are well aligned with common shareholders. A high insider ownership often makes company leadership more mindful of shareholder interests. From our data, it seems that Forte Biosciences insiders own 8.8% of the company, worth about US$6.8m. We do generally prefer see higher levels of insider ownership. It is good to see the recent insider purchase. And the longer term insider transactions also give us confidence. But we don't feel the same about the fact the company is making losses. On this analysis the only slight negative we see is the fairly low (overall) insider ownership; their transactions suggest that they are quite positive on Forte Biosciences stock. In addition to knowing about insider transactions going on, it's beneficial to identify the risks facing Forte Biosciences. Every company has risks, and we've spotted 6 warning signs for Forte Biosciences (of which 4 shouldn't be ignored!) you should know about. If you would prefer to check out another company -- one with potentially superior financials -- then do not miss this free list of interesting companies, that have HIGH return on equity and low debt. For the purposes of this article, insiders are those individuals who report their transactions to the relevant regulatory body. We currently account for open market transactions and private dispositions of direct interests only, but not derivative transactions or indirect interests. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
