Full Press Release Details
Bicara Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update
On track to initiate FORTIFI-HN01, a pivotal Phase 2/3 trial of ficerafusp alfa in 1L R/M HNSCC
Completed upsized initial public offering, raising approximately $362 million in gross proceeds, with full exercise of the
underwriters option to purchase additional shares
Strong financial position with approximately $521 million in cash and
cash equivalents expected to fund operations into the first half of 2029
BOSTON, Nov. 12, 2024 Bicara Therapeutics Inc. (Nasdaq: BCAX),
a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies for patients with solid tumors, today announced financial results for the third quarter ended September 30, 2024 and provided a business
The third quarter of 2024 was momentous for Bicara, highlighted by the successful completion of our upsized initial public offering,
providing us with a robust balance sheet to continue to advance the development of ficerafusp alfa, our bifunctional EGFR/TGF- inhibitor designed to exert potent
anti-tumor activity directly within the tumor microenvironment, said Claire Mazumdar, PhD, MBA, Chief Executive Officer of Bicara Therapeutics. We are currently on track to achieve several anticipated milestones, most notably the
upcoming initiation of FORTIFI-HN01, a pivotal Phase 2/3 trial of ficerafusp alfa, for the treatment of recurrent/metastatic head and neck squamous cell carcinoma, following encouraging interim Phase 1/1b data and alignment with the FDA on the
registrational trial design. Bolstered by our strong financial position with cash runway expected to fund operations into the first half of 2029, we are committed to bringing ficerafusp alfa to patients with head and neck squamous cell carcinoma and
other solid tumors as quickly as possible.
Bicara is developing ficerafusp alfa, a first-in-class, dual-action
bifunctional epidermal growth factor receptor (EGFR)/transforming growth factor beta (TGF- ) antibody for multiple different solid tumor cancer types.
Planned Pivotal Phase 2/3 Clinical Trial in 1L R/M HNSCC
Ongoing Phase 1/1b Clinical Trial in 1L R/M HNSCC
Expansion into Other HNSCC Populations and Solid Tumor Types
Third Quarter 2024 Financial Results
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- ). 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- signaling within the tumor microenvironment. Ficerafusp alfa is being
Forward-Looking Statements
This press release contains
forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, Bicara s expectations regarding plans for its current and future clinical trials, the anticipated
timing of the initiation of FORTIFI-HN01, Bicara s pivotal Phase 2/3 clinical study, the anticipated timing of dosing patients and receiving data from Bicara s Phase 1/1b expansion cohorts evaluating ficerafusp alfa in combination with
pembrolizumab; the expected therapeutic potential and clinical benefits of ficerafusp alfa, including potential efficacy and tolerability, and the timing and success of interactions with and approval of regulatory authority; the anticipated
contribution of the members of Bicara s board of directors to its operations and progress; and financial projections and expectations regarding the time period in which our capital resources will be sufficient to fund our anticipated operations
including our cash runway, use of capital, expenses and other financial results. The words 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 forward-looking statements contain these identifying words. 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), including Bicara s upcoming Quarterly Report on Form 10-Q for the quarter ended September 30, 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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited, in thousands except shares and per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development - related party | $ | 2,310 | $ | 2,271 | $ | 7,400 | $ | 6,511 | ||||||||
| Research and development | 13,554 | 4,668 | 36,336 | 13,544 | ||||||||||||
| General and administrative | 4,764 | 2,591 | 12,016 | 6,147 | ||||||||||||
| Total operating expenses 1 | 20,628 | 9,530 | 55,752 | 26,202 | ||||||||||||
| Loss from operations | (20,628 | ) | (9,530 | ) | (55,752 | ) | (26,202 | ) | ||||||||
| Other (expenses) income | ||||||||||||||||
| Interest income | 3,147 | 13 | 8,715 | 13 | ||||||||||||
| Change in fair value of Series B preferred stock tranche rights liability | (13,328 | ) | (13,356 | ) | ||||||||||||
| Total other income (expense) | 3,147 | (13,315 | ) | 8,715 | (13,343 | ) | ||||||||||
| Net loss before income taxes | (17,481 | ) | (22,845 | ) | (47,037 | ) | (39,545 | ) | ||||||||
| Income tax expense | (1 | ) | ||||||||||||||
| Net loss | $ | (17,481 | ) | $ | (22,845 | ) | $ | (47,038 | ) | $ | (39,545 | ) | ||||
| Net Loss per share, basic and diluted | $ | (1.60 | ) | $ | (38.23 | ) | $ | (11.27 | ) | $ | (70.18 | ) | ||||
| Weighted-average number common shares outstanding, basic and diluted | 10,901,138 | 597,586 | 4,147,353 | 563,483 | ||||||||||||
| 1 Expenses include the following non-cash stock-based compensation expense | ||||||||||||||||
| Research & Development | $ | 1,469 | $ | 398 | $ | 3,172 | $ | 924 | ||||||||
| General and administrative | 562 | 121 | 1,044 | 210 | ||||||||||||
| Total stock-based compensation expense | $ | 2,031 | $ | 519 | $ | 4,216 | $ | 1,134 |
BICARA THEAPEUTICS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except shares and per share data)
| September 30, 2024 | December 31, 2023 | |||||||
| Assets | (Unaudited) | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 520,758 | $ | 230,440 | ||||
| Prepaid expenses and other assets | 756 | 633 | ||||||
| Total current assets | 521,514 | 231,073 | ||||||
| Property and equipment, net | 130 | 202 | ||||||
| Right of use asset operating lease | 414 | 613 | ||||||
| Other assets | 2,115 | 2,094 | ||||||
| Total assets | $ | 524,173 | $ | 233,982 | ||||
| Liabilities, redeemable convertible preferred stock, and stockholders equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,531 | $ | 2,142 | ||||
| Accounts payable related party | 431 | 1,044 | ||||||
| Accrued expenses and other current liabilities | 10,410 | 8,053 | ||||||
| Accrued expenses and other current liabilities related party | 1,801 | 3,561 | ||||||
| Operating lease liability current portion | 308 | 285 | ||||||
| Total current liabilities | 14,481 | 15,085 | ||||||
| Operating lease liability net of current portion | 137 | 372 | ||||||
| Other liabilities | 17 | |||||||
| Total liabilities | 14,618 | 15,474 | ||||||
| Total redeemable convertible preferred stock | 367,277 | |||||||
| Total stockholders equity | 509,555 | (148,769 | ) | |||||
| Total liabilities, redeemable convertible preferred stock, and stockholders equity (deficit) | $ | 524,173 | $ | 233,982 |