Bicara Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
Dosing commenced in FORTIFI-HN01, a pivotal Phase 2/3 trial of ficerafusp alfa in 1L R/M HNSCC
Updated data from ongoing Phase 1/1b trial in 1L R/M HNSCC to be presented at 2025 ASCO Annual Meeting
Strong financial position with approximately $490 million in cash and cash equivalents expected to fund operations into the first half of 2029
BOSTON, March 27, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced financial results for the fourth quarter and full year ended December 31, 2024 and provided a business update.
"2024 was a remarkable year for Bicara, marked by our successful transition to a public company, the advancement of our lead asset, ficerafusp alfa, and the addition of key leaders to our executive team and Board of Directors. We continue to make strong progress in 2025, with patient dosing actively underway in FORTIFI-HN01, the pivotal Phase 2/3 trial of ficerafusp alfa in recurrent/metastatic head and neck squamous cell carcinoma," said Claire Mazumdar, PhD, MBA, Chief Executive Officer of Bicara Therapeutics. "As FORTIFI-HN01 progresses, we look forward to presenting updated data from our ongoing Phase 1/1b study of ficerafusp alfa in 1L R/M HNSCC at the 2025 ASCO Annual Meeting. We also continue to evaluate the potential broad utility of ficerafusp alfa across other areas of head and neck cancer, as well as other solid tumor types."
Pipeline Highlights
Bicara is developing ficerafusp alfa, a first-in-class, dual-action bifunctional epidermal growth factor receptor (EGFR)/transforming growth factor beta (TGF-<BETA>) antibody for multiple different solid tumor cancer types.
Pivotal Phase 2/3 Clinical Trial in 1L R/M HNSCC
-- In February 2025, Bicara dosed the first patients in FORTIFI-HN01, a
global, randomized, double-blind, placebo-controlled, pivotal Phase 2/3
trial of ficerafusp alfa in combination with pembrolizumab in 1L (first
line) recurrent/metastatic (R/M) head and neck squamous cell carcinoma
(HNSCC), excluding patients with oropharyngeal squamous cell carcinoma
associated with human papillomavirus infection (HPV-positive).
Ongoing Phase 1/1b Clinical Trial in 1L R/M HNSCC
-- Updated data from an ongoing Phase 1/1b trial will be presented at the
2025 American Society of Clinical Oncology (ASCO) Annual Meeting, which
will be held from May 30-June 3, 2025 in Chicago, IL.
Ongoing Phase 1/1b Expansion Cohorts and Development of Ficerafusp Alfa Across Other HNSCC Populations and Solid Tumor Types
-- In January 2025, Bicara presented data from the Phase 1/1b dose expansion
cohort of ficerafusp alfa in combination with pembrolizumab in patients
with second line (2L) or later squamous cancer of the anal canal (SCAC)
at the 2025 ASCO Gastrointestinal Cancers Symposium, providing additional
support for the complementary mechanisms of ficerafusp alfa and
pembrolizumab.
-- Updated data from a Phase 1b expansion cohort evaluating ficerafusp alfa
monotherapy in patients with 2L or later cutaneous squamous cell
carcinoma (cSCC) will be presented at the American Association for Cancer
Research (AACR) Annual Meeting 2025, which will be held from April 25-30,
2025 in Chicago, IL.
-- A Phase 1b expansion cohort evaluating ficerafusp alfa both as
monotherapy and in combination with pembrolizumab in patients with 3L+
metastatic colorectal cancer (RAS / BRAF wild type) is expected to
initiate in 2025.
-- A Phase 1b expansion cohort evaluating ficerafusp alfa in combination
with pembrolizumab in HPV-positive patients with a history of heavy
smoking is expected to initiate in the first half of 2025.
Upcoming Events and Presentations
-- Three abstracts related to ficerafusp alfa will be presented at the
upcoming AACR Annual Meeting 2025, which will be held from April 25-30,
2025 in Chicago, IL:
-- Dose expansion results of single agent ficerafusp alfa (BCA101), a
bifunctional EGFR/TGF-<BETA> inhibitor in patients with metastatic
or advanced cutaneous squamous cell carcinoma (cSCC) (Abstract #:
CT034).
-- This presentation will highlight data from a Phase 1/1b
dose expansion cohort of ficerafusp alfa monotherapy in
second line or later cSCC patients.
-- Dual blockade of EGFR and TGF-<BETA> with ficerafusp alfa has the
potential to overcome resistance mechanisms in 1L R/M HNSCC in
combination with Pembrolizumab (Abstract #: 3284).
-- This presentation will highlight a translational medicine
biomarker dataset that provides insights into the effects
of targeted inhibition of TGF-<BETA> with ficerafusp alfa.
-- Ficerafusp alfa reverses acquired resistance to the KRAS-G12C
inhibitor sotorasib in KRAS-G12C-mutated lung tumors (Abstract #:
4434).
-- This presentation will highlight a preclinical dataset that
provides insights into the role of inhibiting TGF-<BETA> in
overcoming acquired KRAS-G12C-inhibitor drug-resistant
KRAS-G12C-mutated lung cancer.
-- Members of the Bicara management team will participate in the Stifel 2025
Virtual Targeted Oncology Forum on Tuesday, April 8, 2025 at 2:00 p.m.
ET. A live webcast of the presentation will be available on the Events
and Presentations section of Bicara's website. A replay of the webcast
will be archived and available following the event.
Fourth Quarter and Full Year 2024 Financial Results
-- Cash Position: As of December 31, 2024, Bicara had cash and cash
equivalents of $489.7 million, compared to $230.4 million as of December
31, 2023. Based on its current operating and development plans, the
Company expects that its existing cash and cash equivalents will fund
operations into the first half of 2029.
-- Research and Development Expenses: Research and development expenses were
$19.9 million and $63.6 million for the fourth quarter and full year
ended December 31, 2024, respectively, as compared to $10.6 million and
$30.6 million for the same periods in 2023. The increase was primarily
due to additional costs associated with the initiation of the
FORTIFI-HN01 Phase 2/3 clinical trial, as well as the Company's ongoing
Phase 1/1b clinical trial to advance ficerafusp alfa.
-- General and Administrative Expenses: General and administrative expenses
were $6.8 million and $18.8 million for the fourth quarter and full year
ended December 31, 2024, respectively, as compared to $3.1 million and
$9.3 million for the same periods in 2023. The increase was primarily due
to additional personnel costs and professional fees to prepare Bicara to
operate as a public company.
-- Net Loss: Net loss totaled $21.0 million and $68.0 million for the fourth
quarter and full year ended December 31, 2024, respectively, as compared
to $12.4 million and $52.0 million for the same periods in 2023. Net loss
for the year ended December 31, 2023 included a $13.4 million non-cash
expense that represents the change in fair value of Bicara's Series B
preferred stock tranche rights liability.
About Bicara Therapeutics
Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara's lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-<BETA>). Through this dual-targeting mechanism, 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. 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 or 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, Bicara's strategy, business plans and focus; express or implied statements regarding the clinical development of ficerafusp alfa, including the initiation, timing, progress and results of ongoing and planned clinical trials; the expected therapeutic potential and clinical benefits of ficerafusp alfa, including potential efficacy and tolerability; Bicara's expected operating expenses and capital expenditure requirements, including its cash runway through the first half of 2029; and participation at upcoming conferences and
the timing of data readouts. 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 and uncertainties related to uncertainties inherent in the development of product candidates, including the conduct of research activities and the conduct of clinical trials; uncertainties as to the availability and timing of results and data from clinical trials; whether results from prior preclinical studies and clinical trials will be predictive of the results of subsequent preclinical studies and clinical trials; regulatory developments in the United States and foreign countries; whether Bicara's cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; as well as the risks and uncertainties identified in Bicara's filings with the Securities and Exchange Commission $(SEC.UK)$, including Bicara's upcoming Annual Report on Form 10-K for the year ended December 31, 2024 and any subsequent filings Bicara makes with the 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.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands except shares and per share data)
Three Months Ended Year Ended
December 31, December 31,
----------------------- -------------------------
2024 2023 2024 2023
------- -------
Operating expenses
Research and
development -
related party $ 816 $ 2,733 $ 8,216 $ 9,244
Research and
development 19,067 7,829 55,403 21,373
General and
administrative 6,754 3,125 18,770 9,272
---------- ------- ---------- -------
Total
operating
expenses(1) 26,637 13,687 82,389 39,889
---------- ------- ---------- -------
Loss from
operations (26,637) (13,687) (82,389) (39,889)
Other (expenses)
income
Interest income 5,866 1,301 14,581 1,314
Change in fair
value of Series
B preferred
stock tranche
rights
liability -- (49) -- (13,405)
---------- ------- ---------- -------
Total other
income
(expense) 5,866 1,252 14,581 (12,091)
---------- ------- ---------- -------
Net loss before
income taxes (20,771) (12,435) (67,808) (51,980)
Income tax
expense (186) (5) (187) (5)
---------- ------- ---------- -------
Net loss $ (20,957) $(12,440) $ (67,995) $(51,985)
========== ======= ========== =======
Net Loss per share,
basic and diluted $ (0.39) $ (19.71) $ (4.05) $ (89.61)
========== ======= ========== =======
Weighted-average
number common
shares
outstanding, basic
and diluted 54,424,607 631,286 16,805,524 580,109
========== ======= ========== =======
(1) Expenses
include the
following non-cash
stock-based
compensation
expense
Research &
Development $ 1,040 $ 171 $ 2,084 $ 381
General and
administrative 2,141 594 5,313 1,518
---------- ------- ---------- -------
Total
stock-based
compensation
expense $ 3,181 $ 765 $ 7,397 $ 1,899
========== ======= ========== =======
BICARA THERAPEUTICS INC.
CONSOLIDATED BALANCE SHEETS
(in thousands)
December 31, December 31,
2024 2023
-------------- ----------------
Assets
Current assets:
Cash and cash equivalents $ 489,711 $ 230,440
Prepaid expenses and other assets 12,822 633
---------- ---------
Total current assets 502,533 231,073
Property and equipment, net 155 202
Right of use asset -- operating lease 690 613
Other assets 6,618 2,094
---------- ---------
Total assets $ 509,996 $ 233,982
========== =========
Liabilities, redeemable convertible
preferred stock, and stockholders' equity
(deficit)
Current liabilities:
Accounts payable $ 3,893 $ 2,142
Accounts payable -- related party 615 1,044
Accrued expenses and other current
liabilities 12,875 8,053
Accrued expenses and other current
liabilities -- related party -- 3,561
Operating lease liability -- current
portion 607 285
---------- ---------
Total current liabilities 17,990 15,085
Operating lease liability -- net of
current portion 131 372
Other liabilities -- 17
---------- ---------
Total liabilities 18,121 15,474
Total redeemable convertible
preferred stock -- 367,277
Total stockholders' equity
(deficit) 491,875 (148,769)
---------- ---------
Total liabilities, redeemable
convertible preferred stock, and
stockholders' equity (deficit) $ 509,996 $ 233,982
========== =========
Contacts
Investors
Rachel Frank
IR@bicara.com
Media
Dan Budwick
1AB
dan@1abmedia.com
(END) Dow Jones Newswires
March 27, 2025 07:30 ET (11:30 GMT)
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