BCAX — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-11

• •Alternate dose study to evaluate loading and every-three-week maintenance regimen: In August 2026, we announced the initiation of FORTIFI-FLEX, a randomized clinical study that will evaluate ficerafusp alfa in combination with pembrolizumab, administered as a 12-week loading dose of 1500mg QW follo…

• ◦1500mg QW, 750mg QW and 2000mg Q2W plus pembrolizumab in 1L R/M HPV-negative HNSCC: In May 2026, we presented extended follow-up data out to three years from the Phase 1b study of ficerafusp alfa in combination with pembrolizumab in 1L R/M HPV-negative HNSCC at the 2026 American Society of Clinical…

• squamous cell carcinoma, as well as ficerafusp alfa in combination with pembrolizumab in patients with second-line or later squamous cancer of the anal canal. These data demonstrated proof-of-concept in both indications and reinforced our conviction in ficerafusp alfa's broad applicability across TG…

• additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and could force us to delay, limit, reduce or terminate our product …

• Our future development costs may vary significantly based on various factors such as timely and successful completion of clinical trials, positive results from our future clinical trials, receipt of marketing approvals from applicable regulatory authorities, establishment of arrangements with third …

Text removed vs the prior filing · source: 10-Q · 2026-05-11

• •Alternate dose study to evaluate loading and every-three-week maintenance regimen: In February 2026, we presented positive data from the Phase 1b expansion cohort evaluating 2000mg of ficerafusp alfa every-other-week in combination with pembrolizumab in 1L HPV-negative R/M HNSCC at the 2026 Multidi…

• ◦1500mg QW, 750mg QW and 2000mg Q2W plus pembrolizumab in 1L R/M HPV-negative HNSCC: In May 2026, our peer-reviewed manuscript was published in the Journal of Clinical Oncology detailing results from the Phase 1b expansion cohort evaluating 1500mg of ficerafusp alfa QW in combination with pembrolizu…

• •Chief Medical Officer transition and appointment of Chief Commercial Officer: On May 8, 2026, Bill Schelman, M.D., Ph.D., previously our Executive Vice President, Clinical Development, succeeded David Raben, M.D. to serve as our Chief Medical Officer, and Dr. Raben has transitioned to serve as a Se…

• Our future development costs may vary significantly based on various factors such as timely and successful completion of clinical trials, positive results from our future clinical trials, receipt of marketing approvals from applicable regulatory authorities, establishment of arrangements with third …

• development could mean a significant change in the costs and timing associated with the development of these therapeutic candidates. For example, if the FDA or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing be…

Text added vs the prior filing · source: 10-Q · 2026-08-11

• On July 15, 2026, the Patent Trial and Appeal Board (“PTAB”) of the United States Patent and Trademark Office instituted a post-grant review petition brought by us against The John Hopkins University, No. PGR2026-00025, concerning a patent in a family alleged to be licensed to Y-Trap, U.S. Patent 12…

Text added vs the prior filing · source: 10-Q · 2026-08-11

• Biopharmaceutical product development entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate efficacy or an acceptable safety profile, gain regulatory approval, secure market access and reimbursement and become com…

• Additionally, our expenses could increase beyond our expectations if we are required by the U.S. Food and Drug Administration, or the FDA, Health Canada, the European Medicines Agency, or the EMA, or other comparable regulatory authorities to perform clinical trials in addition to those that we curr…

• If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties in the future, we may have to relinquish valuable rights to our intellectual property, technologies, future

• revenue streams or product candidates or grant licenses on terms that may not be favorable to us. We could also be required to seek funds through arrangements with collaborators or others at an earlier stage than otherwise would be desirable. Any of these occurrences may have a material adverse effe…

• resources being concentrated among a smaller number of our competitors. As a result of all of these factors, our competitors may succeed in obtaining patent protection and/or FDA, Health Canada, the EMA or other regulatory approval or discovering, developing and commercializing products in our field…

Text removed vs the prior filing · source: 10-Q · 2026-05-11

• Biopharmaceutical product development entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate efficacy or an acceptable safety profile, gain regulatory

• approval, secure market access and reimbursement and become commercially viable, and therefore any investment in us is highly speculative. Accordingly, before making an investment in us, you should consider our prospects, factoring in the costs, uncertainties, delays and difficulties frequently enco…

• Additionally, our expenses could increase beyond our expectations if we are required by the U.S. Food and Drug Administration, or the FDA, Health Canada, the European Medicines Agency, or the EMA, or other comparable regulatory authorities to perform clinical trials in addition to those that we curr…

• If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties in the future, we may have to relinquish valuable rights to our intellectual property, technologies, future revenue streams or product candidates or grant …

• We maintain the majority of our cash, cash equivalents and marketable securities in accounts with major U.S. and multi-national financial institutions, and our deposits at certain of these institutions exceed insured limits. Market conditions and changes in financial regulations and policies can imp…

Text added vs the prior filing · source: 10-Q · 2026-08-11

• On August 10, 2026, the board of directors (the “Board”) of Bicara Therapeutics Inc. (the “Company”) determined that Ivan Hyep will no longer serve as the Company’s Chief Financial Officer, Treasurer, Principal Financial Officer or Principal Accounting Officer, effective as of August 12, 2026 (the “…

• In addition, Mr. Hyep entered into a consulting agreement (the “Consulting Agreement”) with the Company, pursuant to which Mr. Hyep will provide consulting and transition advisory services to the Company from time to time. The Consulting Agreement commences on the CFO Transition Date and continues u…

• On August 10, 2026, the Board appointed Jennifer Larson as Chief Financial Officer, Treasurer, Principal Financial Officer and Principal Accounting Officer of the Company, effective as of the CFO Transition Date.

• Prior to joining the Company, Ms. Larson, age 51, served as Senior Vice President, Chief Financial Officer of Deciphera Pharmaceuticals, Inc. (“Deciphera”), a former publicly traded biopharmaceutical company, from August 2024 to July 2026, as the Senior Vice President of Finance and Investor Relatio…

• In connection with Ms. Larson’s appointment, the Company and Ms. Larson entered into an executive employment agreement, effective on the CFO Transition Date (the “Larson Employment Agreement”), substantially on the Form Employment Agreement (as defined below). The Larson Employment Agreement provide…

Text removed vs the prior filing · source: 10-Q · 2026-05-11

• On May 7, 2026, or the Transition Date, David Raben, M.D. resigned from his role as our Chief Medical Officer and transitioned to serve as a Senior Executive Advisor to the Company, effective on the Transition Date. Dr. Raben’s resignation was not the result of any disagreement with the Company or o…

• In addition, Dr. Raben entered into a consulting agreement, or the Consulting Agreement, with us, pursuant to which Dr. Raben now serves as a Senior Executive Advisor to the Company. The Consulting Agreement was effective as of the Transition Date and ends on December 31, 2026, unless terminated at …

• The following table describes for the three months ended March 31, 2026 each trading arrangement under which our directors or officers adopted, materially modified, or terminated any contract, instruction, or written plan for the purchase or sale of our securities that was intended to satisfy the af…

• Claire Mazumdar, Ph.D. (Chief Executive Officer and Director)

• Until the earlier of a) December 31, 2026; b) the first date on which all trades have been executed or all trading orders related to such trades have expired; and c) the date on which the plan holder gives notice to terminate the plan.