Bicara Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update
Bicara Therapeutics (Nasdaq: BCAX) reported Q3 2024 financial results and business updates. The company completed an upsized IPO raising $362 million in gross proceeds and maintains a strong financial position with $521 million in cash, expected to fund operations into H1 2029. The company is preparing to initiate FORTIFI-HN01, a pivotal Phase 2/3 trial of ficerafusp alfa for head and neck cancer treatment. Current Phase 1/1b trial shows promising results with 64% overall response rate and 18% complete response rate. Q3 financial results show R&D expenses of $15.9 million and G&A expenses of $4.8 million, with a net loss of $17.5 million.
Bicara Therapeutics (Nasdaq: BCAX) ha riportato i risultati finanziari e gli aggiornamenti aziendali del terzo trimestre del 2024. L'azienda ha completato un'IPO aumentata, raccogliendo 362 milioni di dollari in proventi lordi e mantiene una solida posizione finanziaria con 521 milioni di dollari in cassa, previsti per finanziare le operazioni fino alla prima metà del 2029. L'azienda sta preparando l'avvio di FORTIFI-HN01, uno studio clinico cruciale di Fase 2/3 per il trattamento del cancro della testa e del collo con ficerafusp alfa. L'attuale studio di Fase 1/1b mostra risultati promettenti con un tasso di risposta globale del 64% e un tasso di risposta completa del 18%. I risultati finanziari del terzo trimestre mostrano spese per R&S di 15,9 milioni di dollari e spese generali e amministrative di 4,8 milioni di dollari, con una perdita netta di 17,5 milioni di dollari.
Bicara Therapeutics (Nasdaq: BCAX) informó los resultados financieros y las actualizaciones comerciales del tercer trimestre de 2024. La empresa completó una oferta pública inicial (IPO) ampliada, recaudando 362 millones de dólares en ingresos brutos y mantiene una sólida posición financiera con 521 millones de dólares en efectivo, que se espera financien las operaciones hasta la primera mitad de 2029. La empresa se está preparando para iniciar FORTIFI-HN01, un ensayo pivotal de Fase 2/3 de ficerafusp alfa para el tratamiento del cáncer de cabeza y cuello. El ensayo actual de Fase 1/1b muestra resultados prometedores con una tasa de respuesta global del 64% y una tasa de respuesta completa del 18%. Los resultados financieros del tercer trimestre muestran gastos en I+D de 15,9 millones de dólares y gastos generales y administrativos de 4,8 millones de dólares, con una pérdida neta de 17,5 millones de dólares.
비카라 테라퓨틱스 (Nasdaq: BCAX)는 2024년 3분기 재무 결과 및 사업 업데이트를 보고했습니다. 회사는 3억 6200만 달러의 총 수익을 올리는 공모를 성공적으로 완료했으며, 5억 2100만 달러의 현금을 보유하고 있어 2029년 상반기까지 운영 자금이 충분할 것으로 예상됩니다. 회사는 피세라푸스 알파의 두경부암 치료를 위한 주요 2/3상 임상시험인 FORTIFI-HN01을 시작할 준비를 하고 있습니다. 현재 1상/1b상 시험은 64%의 전체 반응률과 18%의 완전 반응률로 유망한 결과를 보여줍니다. 3분기 재무 결과는 1,590만 달러의 연구개발 비용과 480만 달러의 일반 관리 비용을 나타내며, 순손실은 1,750만 달러입니다.
Bicara Therapeutics (Nasdaq: BCAX) a rapporté les résultats financiers et les mises à jour commerciales du troisième trimestre 2024. L'entreprise a complété une IPO augmentée, levant 362 millions de dollars de recettes brutes et maintient une solide position financière avec 521 millions de dollars de liquidités, prévus pour financer les opérations jusqu'au premier semestre 2029. L'entreprise se prépare à lancer FORTIFI-HN01, un essai pivot de Phase 2/3 de ficerafusp alfa pour le traitement des cancers de la tête et du cou. L'essai actuel de phase 1/1b montre des résultats prometteurs avec un taux de réponse global de 64 % et un taux de réponse complète de 18 %. Les résultats financiers du troisième trimestre montrent des dépenses R&D de 15,9 millions de dollars et des dépenses générales et administratives de 4,8 millions de dollars, avec une perte nette de 17,5 millions de dollars.
Bicara Therapeutics (Nasdaq: BCAX) hat die finanziellen Ergebnisse und Unternehmensupdates für das 3. Quartal 2024 veröffentlicht. Das Unternehmen hat ein erweitertes IPO abgeschlossen und 362 Millionen USD an Bruttoerträgen gesammelt und hat eine starke finanzielle Position mit 521 Millionen USD in bar, die voraussichtlich die Operationen bis zur ersten Hälfte von 2029 finanzieren werden. Das Unternehmen bereitet sich darauf vor, FORTIFI-HN01 zu starten, eine entscheidende Phase 2/3-Studie von ficerafusp alfa zur Behandlung von Kopf- und Halskrebs. Die aktuelle Phase 1/1b-Studie zeigt vielversprechende Ergebnisse mit einer Gesamtansprechrate von 64 % und einer vollständigen Ansprechrate von 18 %. Die Finanzzahlen für das 3. Quartal zeigen F&E-Ausgaben von 15,9 Millionen USD und allgemeine Verwaltungsausgaben von 4,8 Millionen USD sowie einen Nettverlust von 17,5 Millionen USD.
- Successful IPO raising $362 million in gross proceeds
- Strong cash position of $521 million with runway into H1 2029
- Phase 1/1b trial showing 64% overall response rate in HNSCC treatment
- FDA alignment achieved for pivotal Phase 2/3 trial design
- Increased R&D expenses from $6.9M to $15.9M YoY
- Higher G&A expenses from $2.6M to $4.8M YoY
- Net loss of $17.5M in Q3 2024
Insights
The successful IPO raising
Q3 operating expenses show expected increases in R&D (
The clinical data for ficerafusp alfa shows strong potential in head and neck cancer treatment. Key metrics include a
The upcoming pivotal FORTIFI-HN01 trial design has FDA alignment, reducing regulatory risk. The expansion into multiple indications including anal canal and cutaneous squamous cell carcinoma demonstrates the broad potential of this novel bifunctional EGFR/TGF-β approach. Near-term catalysts include trial initiation in Q4 2024/Q1 2025 and multiple data readouts in 2025.
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
Strong financial position with approximately
BOSTON, Nov. 12, 2024 (GLOBE NEWSWIRE) -- 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 update.
“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-β 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.”
Pipeline Highlights
Bicara is developing ficerafusp alfa, a first-in-class, dual-action bifunctional epidermal growth factor receptor (EGFR)/transforming growth factor beta (TGF-β) antibody for multiple different solid tumor cancer types.
Planned Pivotal Phase 2/3 Clinical Trial in 1L R/M HNSCC
- The Company has aligned with the U.S. Food and Drug Administration on the design of FORTIFI-HN01, a 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) and expects to initiate the trial late in the fourth quarter of 2024 or early in the first quarter of 2025.
Ongoing Phase 1/1b Clinical Trial in 1L R/M HNSCC
- In an ongoing Phase 1/1b trial, ficerafusp alfa in combination with pembrolizumab has demonstrated clinically meaningful anti-tumor activity, with a
64% overall response rate,18% complete response rate and median progression free survival of 9.8 months in frontline human papillomavirus (HPV)-negative R/M HNSCC, along with a favorable tolerability profile, as of the April 2024 data cut-off date (presented at the 3rd Hawaii Global Summit on Thoracic Malignancies in June 2024). - Updated data from an ongoing Phase 1/1b trial is expected at a medical meeting in the first half of 2025.
Expansion into Other HNSCC Populations and Solid Tumor Types
- Data from a Phase 1b expansion cohort evaluating ficerafusp alfa in combination with pembrolizumab in second line (2L) or later squamous cancer of the anal canal is expected at a medical meeting in the first quarter of 2025.
- Updated data from a Phase 1b expansion cohort evaluating ficerafusp alfa monotherapy in 2L or later cutaneous squamous cell carcinoma is expected at a medical meeting in the first half of 2025.
Business Highlights
- In September 2024, Bicara completed its initial public offering (IPO) of 20,125,000 shares of its common stock at a public offering price of
$18.00 per share, including full exercise of the underwriters’ option to purchase additional shares, raising gross proceeds of approximately$362 million , before deducting underwriting discounts, commissions and other offering expenses. Shares began trading on the Nasdaq Global Market under the symbol “BCAX.” - In conjunction with its IPO in September 2024, Bicara appointed its President and Chief Operating Officer, Ryan Cohlhepp, PharmD, as a Director to its Board of Directors.
- In August 2024, Bicara expanded its Board of Directors with the appointments of biopharma industry leaders Mike Powell, PhD, as Chairman of the Board, and Christopher Bowden, MD, as a Director.
Third Quarter 2024 Financial Results
- Cash Position: As of September 30, 2024, Bicara had cash and cash equivalents of
$520.8 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
$15.9 million for the third quarter of 2024, compared to$6.9 million for the third quarter of 2023. The increase was primarily due to additional costs associated with the Company’s ongoing clinical trials to advance ficerafusp alfa. - General and Administrative Expenses: General and administrative expenses were
$4.8 million for the third quarter of 2024, compared to$2.6 million for the third quarter of 2023. The increase in general and administrative expenses was primarily due to additional personnel costs and professional fees to prepare Bicara to operate as a public company. - Net Loss: Net loss was
$17.5 million for the third quarter of 2024, compared to$22.8 million for the third quarter of 2023. Net loss for the third quarter of 2023 included a$13.3 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-β). 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-β 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, 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.
Contacts
Investors
Rachel Frank
IR@bicara.com
Media
Dan Budwick
1AB
dan@1abmedia.com
| 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 expenses1 | 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 | 4,174,353 | 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 | |||
FAQ
What were Bicara Therapeutics (BCAX) Q3 2024 financial results?
How much did Bicara Therapeutics (BCAX) raise in its IPO?
What are the clinical trial results for ficerafusp alfa by BCAX?
