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Business Wire
7 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
23-04-2025
- Business
- Yahoo
Google, University of Arizona support Chandler Unified schools' cybersecurity clinic
High school students in an East Valley district can now participate in an innovative cybersecurity clinic supported by Google and the University of Arizona. The clinic is being offered at Basha and Arizona College Preparatory high schools, supplementing Chandler Unified School District's existing four-year cybersecurity programs at Basha and Chandler high schools. Chandler Unified students were already able to earn college credits from Chandler Gilbert Community College as they learned about this rapidly developing field. For students looking to get cybersecurity training, the district has provided them a 'pathway from the high school to the community college and then to the university to reduce costs, provide access and early career engagement,' said Paul Wagner, a University of Arizona professor who helped launch the Chandler Unified clinic. In June 2024, UA was awarded a $1 million grant from Google's Cybersecurity Clinics Fund to help the university establish its own cybersecurity clinic. Wagner thought it would be a good idea to offer Google's online cybersecurity certification to high school students as well, building the country's first high school cybersecurity clinic. "Since it affects students so closely, I think it's important for everyone to understand and know the bare minimum," said Sumedha Balwadgi, an Arizona College Prep senior who completed the certificate program. "This is a skill that is applicable in all sectors," Badgalwi said. "I'm planning on going into engineering at college, and I am confident that it's going to come up and be useful." Modeled after legal clinics, where law students get work experience in their field, cybersecurity clinics are meant to bridge the experience gap that graduating students face when applying for entry-level jobs. 'We thought maybe 10 or so students would join this opportunity, and then we had almost 100 people registered for the Google Cybersecurity Professional Certificate,' Wagner said. Chandler Unified students were able to complete Google's course free of charge outside of class. On March 25, 59 students received their certification at a ceremony in Arizona College Prep's auditorium. The school district hopes the clinic will provide opportunities for its students to market themselves to future employers and build connections within an industry that continues to grow in Arizona. 'We have over 50 semiconductor companies just in Chandler alone," between the supply chain and fabrication plants, said Janet Hartkopf, Chandler Unified's coordinator for emerging technologies. She oversaw the creation of the cybersecurity clinics with the goal of preparing students 'for all aspects of those types of jobs.' While no credential guarantees a job, the clinic's certification could help students land internships or entry-level jobs. Students are encouraged to post their certification as a digital badge and connect with their cybersecurity instructor via LinkedIn to start building a professional network. For students who want to continue their cybersecurity training in the fall semester, the University of Arizona is offering Chandler Unified students its micro-credential in cybersecurity risk and vulnerability assessment. Teachers will have access to course material from the University of Arizona's cybersecurity program to adapt for high school students. After acquiring their micro-credential, students will then be tasked with completing risk-assessment surveys for schools across the district to apply what they have learned. 'Employers want to see that you have hands-on experience, and they want to see that you had the initiative as a high schooler to get the certificate and give back in your community with a real-world organization,' said Anne Cleaveland, co-chair of the Consortium of Cybersecurity Clinics. Chandler Unified is also offering six internships to students who have completed both Google's certification and the University of Arizona's micro-credential to work alongside district IT professionals. These internships will be completed on students' own free time and will not be paid, but they will offer a rare opportunity for high school students looking to complete internships before the age of 18. To protect critical and private information, students will not have access to any sensitive data throughout the internship. The district also plans to add courses on "cyber hygiene" that will introduce students to protecting themselves and businesses from phishing scams and malware, and offer students the chance to pitch themselves to complete cyber-hygiene assessments for local companies. There are currently no plans to expand the clinics to other high schools, so Chandler Unified encourages interested incoming ninth graders to apply to either Basha or Arizona College Prep. "I think being able to complete this was the highlight of my senior year," Balwadgi said. "I was involved in a lot of things related to this, and it was a new skill that I'll definitely take away in college and future career." Coverage of education solutions on and in The Arizona Republic is partially supported by a grant from the Arizona Local News Foundation's Arizona Community Collaborative Fund. This article originally appeared on Arizona Republic: Chandler Unified students can now receive cybersecurity experience
