Study to evaluate ficerafusp alfa in combination with pembrolizumab as a loading and every-three-week maintenance regimen in 1L R/M HPV-negative HNSCC expected to initiate in Q3 2026
Long-term follow-up data from Phase 1b study of ficerafusp alfa in combination with pembrolizumab in 1L R/M HPV-negative HNSCC patients to be presented at ASCO 2026
Bill Schelman, M.D., Ph.D., EVP, Clinical Development promoted to Chief Medical Officer, and David Raben, M.D., Chief Medical Officer transitioned to serve as a Senior Executive Advisor to the company
Chris Sarchi appointed as Chief Commercial Officer
BOSTON, May 11, 2026 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX) today announced financial results for the first quarter ended March 31, 2026 and provided a business update.
"The first quarter of 2026 reflects strong progress as we work to position ficerafusp alfa as the cornerstone of treatment in HPV-negative head and neck cancer. In addition to advancing our FORTIFI-HN01 pivotal trial, we continued to enroll patients in additional Phase 1b signal-seeking studies as we aim to unlock the full blockbuster potential of ficerafusp alfa. Based on recent FDA discussions, we plan to initiate a randomized study to evaluate a loading and every-three-week maintenance dosing regimen -- further differentiating ficerafusp alfa and expanding optionality for patients and providers. We also look forward to sharing an important data update at ASCO 2026, which will further characterize the role of TGF-<BETA> in driving depth and durability of response across three 1L R/M HNSCC expansion cohorts," said Claire Mazumdar, Ph.D., Chief Executive Officer at Bicara Therapeutics. "Alongside our clinical progress, we are rapidly evolving toward becoming a commercial-stage company, and to support that evolution, today we announced several executive changes. David Raben has transitioned from Chief Medical Officer to a Senior Executive Advisor role after three years of instrumental contributions, and Bill Schelman, formerly Executive Vice President of Clinical Development, has stepped into the Chief Medical Officer role. We have also welcomed Chris Sarchi as our Chief Commercial Officer, who brings extensive oncology commercialization and leadership experience as we build toward launch."
First Quarter 2026 Highlights and Recent Progress
FORTIFI-HN01: Pivotal Phase 2/3 Clinical Trial of Ficerafusp Alfa in First Line (1L) Recurrent or Metastatic (R/M) HPV-Negative Head and Neck Squamous Cell Carcinoma (HNSCC)
-- Continued strong execution in FORTIFI-HN01, our pivotal trial in 1L
HPV-negative R/M HNSCC; expect to be substantially enrolled by the end of
the year to enable an interim analysis in mid-2027 to support potential
accelerated approval.
-- Based on recent discussions with the U.S. Food and Drug Administration
(FDA), the company plans to initiate a randomized clinical study that
will evaluate ficerafusp alfa in combination with pembrolizumab,
administered as a 12-week loading dose of 1500mg weekly (QW) followed by
maintenance dosing of 2250mg every three weeks (Q3W). The company expects
to initiate the study in the third quarter of 2026 to have results in
time for potential U.S. accelerated approval.
Phase 1b Studies of Ficerafusp Alfa Across HNSCC and Other Solid Tumor Types
-- Continued to enroll multiple Phase 1b expansion cohorts to identify early
proof-of-concept signals and inform ficerafusp alfa development strategy
beyond 1L R/M HPV-negative HNSCC.
-- Published a manuscript detailing results from a Phase 1b expansion cohort
evaluating 1500mg of ficerafusp alfa QW in combination with
pembrolizumab in 1L R/M HNSCC in the Journal of Clinical Oncology. Read
the manuscript here.
Corporate Highlights
-- Announced that effective May 8, 2026, Bill Schelman, M.D., Ph.D.,
previously the company's Executive Vice President, Clinical Development,
has succeeded David Raben, M.D., as Chief Medical Officer, and Dr. Raben
has transitioned to serve as a Senior Executive Advisor. With this
promotion, Dr. Schelman is responsible for medical affairs and clinical
development. In his new role, Dr. Raben will advise on clinical
development strategy across the company's portfolio.
-- Announced that effective May 8, 2026, Chris Sarchi was appointed as Chief
Commercial Officer. In this role, he will lead the commercial
organization in preparation for launch readiness.
Key Anticipated Upcoming Milestones
HNSCC
-- Present long-term follow-up data, which will further characterizing the
role of TGF-<BETA> inhibition in driving depth and durability of response,
from three Phase 1b expansion cohorts of ficerafusp alfa in combination
with pembrolizumab in 1L R/M HPV-negative HNSCC at the 2026 American
Society of Clinical Oncology (ASCO) Annual Meeting, which will be held
from May 29-June 2, 2026 in Chicago, IL.
Other Solid Tumors, Including mCRC
-- Present data from Phase 1b expansion cohort evaluating ficerafusp alfa
both as monotherapy and in combination with pembrolizumab in patients
with 3L+ mCRC (RAS/BRAF wild type MSS) in the second half of 2026.
First Quarter 2026 Financial Results
-- Cash, Cash Equivalents and Marketable Securities: As of March 31, 2026,
Bicara had cash, cash equivalents and marketable securities of $539.8
million, compared to $414.8 million in cash, cash equivalents and
marketable securities as of December 31, 2025. The company received
approximately $161.8 million in net proceeds from an oversubscribed
public offering in the first quarter of 2026. Based on its current
operating and development plans, the company expects that its existing
cash, cash equivalents and marketable securities will fund operations
into the first half of 2029.
-- Research and Development Expenses: Research and development expenses were
$47.5 million for the first quarter of 2026 as compared to $34.3 million
for the first quarter of 2025. The increase was primarily due to costs
associated with the ongoing FORTIFI-HN01 pivotal trial, as well as the
company's ongoing Phase 1/1b dose expansion cohorts, and an increase in
personnel costs.
-- General and Administrative Expenses: General and administrative expenses
were $12.7 million for the first quarter of 2026 as compared to $7.5
million for the first quarter of 2025. The increase was primarily due to
additional personnel costs and professional fees to support advancement
of our clinical trials.
-- Net Loss: Net loss totaled $56.2 million for the first quarter of 2026
compared to $36.8 million for the first quarter of 2025.
Upcoming Investor Conferences
Bicara Therapeutics will participate in two upcoming investor conferences:
-- BofA Securities Health Care Conference 2026 on Wednesday, May 13, 2026 at
9:20 a.m. PT.
-- TD Cowen 7th Annual Oncology Innovation Summit: Insights for ASCO & EHA
on Wednesday, May 27, 2026 at 10:30 a.m. ET.
A live webcast of the fireside chats will be accessible through the Investor Relations section of Bicara's website under Events and Presentations. A replay of the webcast will be archived and available for 30 days following the event.
Conference Call Information
Bicara will host a live conference call and webcast at 8:30 a.m. ET today to discuss first quarter 2026 financial results and recent business activities. Individuals may register for the conference call by clicking the link here. Once registered, participants will receive dial-in details and a unique PIN that will allow them to access the call. An audio webcast will be accessible through the Investor Relations section of Bicara's website under Events and Presentations. An archived replay will also be available for 30 days following the event.
About Bicara Therapeutics
Bicara is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara has built a platform designed to facilitate the development of bifunctional therapies that precisely target the tumor and deliver a tumor-modulating payload to the tumor site. This approach was deployed in the development of Bicara's lead program ficerafusp alfa, formerly BCA101, a bifunctional epidermal growth factor receptor (EGFR) directed monoclonal antibody bound to a human transforming growth factor beta (TGF-<BETA>) ligand trap. By combining these two clinically validated targets, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-<BETA> signaling within the tumor microenvironment $(TME)$. Ficerafusp alfa directs the TGF-<BETA> inhibitor into the immediate TME through the binding of EGFR on tumor cells, which Bicara believes will lead to deep and durable responses and an increase in overall survival, while reducing the potential adverse effects previously associated with systemic TGF-<BETA> inhibition. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit www.bicara.com or follow us on LinkedIn and X.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as "may," "might," "will," "could," "would," "should," "plan," "anticipate," "intend," "believe," "expect," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target" and similar words or expressions, or the negative thereof, are intended to identify forward-looking statements, although not all contain identifying words. Any statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, express or implied statements regarding Bicara's strategy, business plans and focus; the clinical development of ficerafusp alfa, including the initiation, timing, progress, results and future data releases of Bicara's ongoing and planned clinical trials; the advancement of the FORTIFI-HN01 pivotal trial in 1L HPV-negative R/M HNSCC and Bicara's expectation for the trial to be substantially enrolled by the end of the year and an interim analysis mid-2027; the timing of future data releases from Bicara's ongoing Phase 1/1b expansion cohorts; the initiation of an alternate dose study in the third quarter of 2026 to evaluate a loading and every-three-week maintenance dosing regimen of ficerafusp alfa and expectations for results in time for potential U.S. accelerated approval; the expected therapeutic potential and clinical benefits of ficerafusp alfa, including potential efficacy, depth, durability and tolerability as compared to the existing standard of care; Bicara's ability to scale and prepare for potential commercialization of ficerafusp alfa; anticipated contributions of members of Bicara's leadership team; the potential for regulatory approval and U.S. launch of ficerafusp alfa; and Bicara's expected operating expenses and capital expenditure requirements, including its cash runway into the first half of 2029. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks and uncertainties that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks relating to Bicara's research and development activities; Bicara's ability to execute on its business plans and strategy, including obtaining the requisite regulatory approvals on the expected timeline, if at all; uncertainties relating to the clinical development of ficerafusp alfa; the Company's dependence on third parties; risks related to the Company's financial condition and need for additional funds in order to commercialize ficerafusp alfa, if approved; risks related to regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; risks related to establishing and maintaining Bicara's intellectual property protections; and risks related to the competitive landscape for ficerafusp alfa; as well as other risks described in "Risk Factors," in Bicara's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Bicara's subsequent filings with the U.S. Securities and Exchange Commission (SEC). In addition, any forward-looking statements represent Bicara's views only as of today and should not be relied upon as representing its views as of any subsequent date. Bicara explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Bicara intends to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company's Investor Relations website, in addition to following the Company's press releases, SEC filings, public conference calls, presentations, and webcasts.
BICARA THERAPEUTICS INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE
LOSS
(Unaudited, in thousands except shares and per share
data)
Three Months Ended March 31,
2026 2025
------------ -----------
Operating expenses
Research and development $ 47,500 $ 34,333
General and administrative 12,742 7,455
------------ -----------
Total operating expenses(1) 60,242 41,788
------------ -----------
Loss from operations (60,242) (41,788)
Other income
Interest income 4,083 5,014
------------ -----------
Total other income 4,083 5,014
------------ -----------
Net loss before income taxes (56,159) (36,774)
Income tax expense (52) (72)
------------ -----------
Net loss $ (56,211) $ (36,846)
============ ===========
Net Loss per share, basic and
diluted $ (0.93) $ (0.68)
============ ===========
Weighted-average number common
shares outstanding, basic and
diluted 60,717,041 54,456,515
============ ===========
Other comprehensive loss:
Unrealized loss on marketable
securities, net of tax (486) --
------------ -----------
Total other comprehensive loss (486) --
------------ -----------
Total comprehensive loss $ (56,697) $ (36,846)
============ ===========
(1) Expenses include the following
non-cash stock-based compensation
expense
Research & Development $ 2,225 $ 1,141
General and administrative 3,633 2,310
------------ -----------
Total stock-based compensation
expense. $ 5,858 $ 3,451
============ ===========
BICARA THERAPEUTICS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited, in thousands)
March 31, 2026 December 31, 2025
---------------- -------------------
Assets
Current assets:
Cash and cash equivalents $ 323,462 $ 96,685
Prepaid expenses and other
assets 5,162 7,252
Marketable securities 216,291 318,116
------------ --- --------------
Total current assets 544,915 422,053
Property and equipment, net 346 330
Right of use asset -- operating
lease 1,428 1,701
Other assets 6,910 6,910
------------ --- --------------
Total assets $ 553,599 $ 430,994
============ === ==============
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $ 6,188 $ 5,515
Accounts payable -- related
party 1,252 2,278
Accrued expenses and other
current liabilities 29,948 18,898
Accrued expenses and other
current liabilities -- related
party 812 1,141
Operating lease liability --
current portion 1,140 1,117
------------ --- --------------
Total current liabilities 39,340 28,949
Operating lease liability -- net
of current portion 301 593
------------ --- --------------
Total liabilities 39,641 29,542
Total stockholders' equity 513,958 401,452
------------ --- --------------
Total liabilities and
stockholders' equity $ 553,599 $ 430,994
============ === ==============
Contacts
Investors
Rachel Frank
IR@bicara.com
Media
Tim Palmer
tim.palmer@bicara.com
(END) Dow Jones Newswires
May 11, 2026 07:30 ET (11:30 GMT)
Comments