Pembrolizumab

Soquelitinib Atopic Dermatitis Phase 1 Clinical Trial Enrolling Patients in Second Dosing Cohort Interim Data from Atopic Dermatitis Trial Expected to be Announced December 2024 Registration Phase 3 Clinical Trial of Soquelitinib in Peripheral T Cell Lymphoma (PTCL) Enrolling with Multiple Clinical Sites Open Conference call today at 4:30 p.m. ET / 1:30 p.m. PT BURLINGAME, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the third quarter ended September 30, 2024. “There is strong interest from clinicians and patients in both of our clinical programs for soquelitinib – the registration Phase 3 clinical trial in PTCL and the Phase 1 clinical trial in atopic dermatitis – and we are pleased with ongoing enrollment in these trials,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “ITK inhibition offers a novel mechanism of action that inhibits multiple parallel signaling pathways that modulate T cell function and immunity, giving it broad potential across a range of indications in oncology and immune disease. Its clinical potential has already been demonstrated in PTCL and we look forward to presenting interim data from our Phase 1 clinical trial in atopic dermatitis in December. We are excited for the potential of ITK inhibition to provide a new oral treatment option for atopic dermatitis, with the potential for improved efficacy, and with a more convenient and tolerable profile than biologics.” Business Update and Strategy Prioritized Program: Soquelitinib (Corvus’ selective ITK inhibitor) Soquelitinib for Immune Diseases Corvus continues to enroll patients at multiple clinical sites in its randomized, placebo-controlled Phase 1 clinical trial of soquelitinib in patients with moderate to severe atopic dermatitis. The trial is planned to enroll 64 patients that have failed at least one prior therapy across four different 28-day dosing regimens of soquelitinib compared to a placebo group. Patients are followed for an additional 30 days after completing the 28 day course of therapy. The endpoints include safety and improvement in the Eczema Area and Severity Index. Patients and physicians are blinded to the treatment assignment. Enrollment in the first cohort (100 mg, twice per day) has been completed and the data review committee has met and found no safety signals. The second cohort (200 mg, once-daily) is now enrolling patients. Corvus plans to announce interim data from the Phase 1 clinical trial in December 2024. In November, Corvus plans to present new preclinical data highlighting the potential of soquelitinib to prevent lung damage, inflammation and pulmonary hypertension caused by systemic sclerosis at ACR Convergence 2024, the annual meeting of the American College of Rheumatology.Corvus continues to advance its next-generation ITK inhibitor preclinical product candidates, which were designed to deliver precise T-cell modulation that is optimized for specific immunology indications. Soquelitinib for T Cell Lymphoma Corvus continues to enroll patients in a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed PTCL at multiple sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate. The primary endpoint of the trial is progression free survival.There are no FDA fully approved agents for the treatment of relapsed PTCL and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory peripheral T cell lymphoma after at least 2 lines of systemic therapy. Collaboration with Kidney Cancer Research Consortium: Ciforadenant (adenosine A2a receptor inhibitor) Corvus is collaborating with the Kidney Cancer Research Consortium in a Phase 1b/2 clinical trial evaluating ciforadenant as a potential first line therapy for metastatic renal cell cancer (RCC) in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The efficacy endpoint for the trial is deep response rate, defined as CR plus PRs of greater than 50% tumor volume reduction. The clinical trial is expected to enroll up to 60 patients and as of September 30, 2024, a total of 46 patients were enrolled in the trial. The protocol defined, interim pre-specified statistical threshold for efficacy is a 50% increase above the 32% deep response rate seen with previous ipilimumab/nivolumab combination trials in RCC conducted by investigators at the Kidney Cancer Research Consortium. The analysis of the clinical trial continues to meet the threshold for efficacy and therefore enrollment continues. Along with our partners at the Kidney Cancer Research Consortium, we have decided to continue our follow-up of patients on the trial before presenting the data. Therefore, we will not be presenting this data at the GU Malignancy conference taking place in late November and will instead target a presentation sometime in 2025.The Phase 1b/2 clinical trial in patients with metastatic RCC is supported by data presented in November at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting highlighting the potential of ciforadenant to overcome immunotherapy resistance in metastatic castration resistant prostate cancer. Financial Results As of September 30, 2024, Corvus had cash, cash equivalents and marketable securities of $41.7 million as compared to $27.1 million as of December 31, 2023. In October 2024, a holder of 1,677,220 common stock warrants early exercised all of their warrants resulting in cash proceeds of approximately $5.9 million. Corvus expects full year 2024 net cash used in operating activities to be between approximately $25 million and $26 million, resulting in a projected cash balance of between approximately $38 million and $39 million at December 31, 2024. Based on its current plans, Corvus expects its cash to fund operations into 2026. Research and development expenses for the three months ended September 30, 2024 totaled $5.2 million compared to $4.0 million for the same period in 2023. The increase of approximately $1.2 million was primarily due to higher clinical trial costs associated with the development of soquelitinib. The net loss for the three months ended September 30, 2024 was $40.2 million compared to a net loss of $6.0 million for the same period in 2023. Total stock compensation expense for the three months ended September 30, 2024 was $0.7 million compared to $0.5 million for the same period in 2023 and the non-cash loss from Corvus’ equity method investment in Angel Pharmaceuticals was $0.7 million for the three months ended September 30, 2024 compared to a loss of $0.9 million for the same period in 2023. In addition, the Company recorded a non-cash loss of $32.8 million related to an increase in the fair value of its warrant liability during the three months ended September 30, 2024 due an increase in the Company’s stock price from $1.82 at June 30, 2024 to $5.28 at September 30, 2024. The Company issued approximately 17.1 million common stock warrants in its May 2024 registered direct offering with an exercise price of $3.50 per common stock warrant. After the October 2024 early exercise of 1,677,220 common stock warrants, approximately 15.4 million common stock warrants remain outstanding. The common stock warrants expire on June 30, 2025. Conference Call DetailsCorvus will host a conference call and webcast today, Tuesday, November 12, 2024, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the third quarter 2024 financial results. The conference call can be accessed by dialing 1- 800-717-1738 (toll-free domestic) or 1- 646-307-1865 (international) or by clicking on this link for instant telephone access to the event. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days. About Corvus PharmaceuticalsCorvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com. About SoquelitinibSoquelitinib (formerly CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. Based on interim results from a Phase 1/1b clinical trial in patients with refractory T cell lymphomas, which demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, the Company initiated a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed PTCL. Soquelitinib also is now being investigated in a randomized placebo controlled phase 1 clinical trial in patients with atopic dermatitis. The immunologic effects of soquelitinib lead to what is known as Th1 skewing and inhibition of Th2 and Th17 cells. Research on soquelitinib’s mechanism of action suggests that it has the potential to control differentiation of normal T helper cells and enhance immune responses to tumors by augmenting the generation of cytotoxic killer T cells and the production of cytokines that inhibit cancer cell survival. Soquelitinib has also been shown to prevent T cell exhaustion, a major limitation of current immunotherapy and CAR-T therapies. Soquelitinib has been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of their secreted cytokines. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with cancers, including solid tumors, and in patients with autoimmune and allergic diseases. About Peripheral T Cell LymphomaPeripheral T cell lymphoma is a heterogeneous group of malignancies accounting for about 10% of non-Hodgkin’s lymphomas (NHL) in Western populations, reaching 20% to 25% of NHL in some parts of Asia and South America. The most common subtypes are PTCL-not otherwise specified (PTCL-NOS) and T follicular helper cell lymphoma. First line treatment for these diseases is typically combination chemotherapy, however, approximately 75% of patients either do not respond or relapse within the first two years. Patients in relapse are treated with various chemotherapy agents but have poor overall outcomes with median progression-free survival in the three to four month range and overall median survival of six to 12 months. There are no approved drugs in relapsed PTCL based on randomized trials. PTCL is a disease of mature helper T cells that express ITK, often containing numerous genetic mutations and frequently associated with viral infection. Most often the malignant cells of PTCL express a Th2 phenotype. About Atopic DermatitisAtopic dermatitis, also called eczema, is a chronic disease that can cause inflammation, redness, scaly patches, blisters and irritation of the skin. It affects up to 20% of children and up to 10% of adults, and treatments include topical therapies, oral therapies and systemic injectable biologic therapies. It is frequently associated with other allergic disorders such as food allergies and asthma. Atopic dermatitis, like asthma and allergy, involves the participation of Th2 lymphocytes which secrete cytokines that result in inflammation. Soquelitinib has been shown in preclinical studies to inhibit cytokine production from Th2 lymphocytes. About CiforadenantCiforadenant (CPI-444) is an investigational small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine to immune cells present in the tumor microenvironment. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2a receptor present on immune cells and block their activity. Ciforadenant has been shown to block the immunosuppressive effects of myeloid cells present in tumors and preclinical studies published in 2018 demonstrated synergy with combinations of anti PD1 and anti-CTLA4 antibodies. About MupadolimabMupadolimab (CPI-006) is an investigational, potent humanized monoclonal antibody that is designed to react with a specific site on CD73. In preclinical studies, it has demonstrated immunomodulatory activity resulting in activation of lymphocytes, induction of antibody production from B cells and effects on lymphocyte trafficking. While there are other anti-CD73 antibodies and small molecules in development for treatment of cancer, such agents react with a different region of CD73. Mupadolimab is designed to react with a region of the molecule that acts to stimulate B cells and block production of immunosuppressive adenosine. Mupadolimab is being studied in combination with pembrolizumab in a Phase 1b/2 clinical trial in patients with advanced head and neck cancers and in patients with NSCLC that have failed chemotherapy and anti-PD(L)1 therapy. It is postulated that the activation of B cells will enhance immunity within the tumors of these patients, leading to improved clinical outcomes. About Angel PharmaceuticalsAngel Pharmaceuticals is a privately held biopharmaceutical company developing a pipeline of precisely targeted investigational medicines for cancer, autoimmune, infectious and other serious diseases in China. Angel Pharmaceuticals was launched through a collaboration with U.S.-based Corvus and investments from investors in China. Angel Pharmaceuticals licensed the rights to develop and commercialize Corvus’ three clinical-stage candidates – soquelitinib, ciforadenant and mupadolimab – in greater China and obtained global rights to Corvus’ BTK inhibitor preclinical programs. Under the collaboration, Corvus currently has a 49.7% equity stake in Angel Pharmaceuticals excluding 7% of Angel’s equity reserved for issuance under the Angel ESOP, and Corvus has designated three individuals on Angel’s five-person Board of Directors. For more information, visit www.angelpharma.com. Forward-Looking StatementsThis press release contains forward-looking statements, including statements related to the potential safety and efficacy of the Company’s product candidates including soquelitinib, ciforadenant and mupadolimab; the potential use of soquelitinib to treat a variety of hematological cancers and autoimmune diseases; the potential of ciforadenant to overcome immunotherapy resistance in metastatic castration resistant prostate cancer; the potential of ITK inhibition to provide a new oral treatment option for atopic dermatitis; the Company’s ability and its partners’ ability, as well as the timing thereof, to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company’s registrational Phase 3 clinical trial for PTCL with soquelitinib and its Phase 1 clinical trial for atopic dermatitis with soquelitinib; the timing of and the Company’s ability to launch clinical trials, including the soquelitinib Phase 1 clinical trial for solid tumors; the design of clinical trials, including the timeline for initiation, target or expected number of patients to be enrolled, expected number of sites and certain other product development milestones, including in regards to the Phase 1 clinical trial for atopic dermatitis with soquelitinib and the registrational Phase 3 clinical trial for PTCL with soquelitinib; the availability and timing of clinical and preclinical data announcements and clinical readouts, including interim data from the Phase 1 clinical trial for atopic dermatitis with soquelitinib and preclinical data highlighting the potential of soquelitinib to prevent lung damage, inflammation and pulmonary hypertension caused by systemic sclerosis; the estimated amount of net cash used in operating activities for 2024 and its ability to fund operations into 2026. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the three months ended September 30, 2024, filed with the Securities and Exchange Commission on or about the date hereof, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of soquelitinib and its other product candidates; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials and release data from such studies and clinical trials; the results of preclinical studies and interim data from clinical trials not being predictive of future results; the Company’s ability to enroll sufficient numbers of patients in its clinical trials; the unpredictability of the regulatory process; regulatory developments in the United States, and other foreign countries; the costs of clinical trials may exceed expectations; the Company’s ability to accurately estimate the amount of net cash used in operating activities for 2024 and cash on hand providing funding into 2026 and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. The Company’s results for the quarter ended September 30, 2024 are not necessarily indicative of its operating results for any future periods. CORVUS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 (unaudited) (unaudited)Operating expenses: Research and development $5,222 $3,965 $13,411 $12,527 General and administrative 2,033 1,595 6,032 5,229 Total operating expenses 7,255 5,560 19,443 17,756 Loss from operations (7,255) (5,560) (19,443) (17,756)Interest income and other expense, net 566 425 1,316 1,204 Change in fair value of warrant liability (32,846) — (31,030) — Sublease income - related party — — — 56 Loss from equity method investment (682) (865) (1,023) (3,880)Net loss $(40,217) $(6,000) $(50,180) $(20,376)Net loss per share, basic and diluted$(0.60) $(0.12) $(0.86) $(0.43)Shares used to compute net loss per share, basic and diluted 66,701,086 48,971,246 58,513,303 47,683,792 CORVUS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) September 30,December 31, 2024 2023 (unaudited) Assets Cash, cash equivalents and marketable securities$41,651 $27,149Operating lease right-of-use asset 284 1,149Other assets 1,693 1,132Investment in Angel Pharmaceuticals 15,187 16,123Total assets$58,815 $45,553Liabilities and stockholders' equity Accounts payable and accrued liabilities and other liabilities$6,088 $5,495Operating lease liability 354 1,374Warrant liability 39,964 —Stockholders' equity 12,409 38,684Total liabilities and stockholders' equity$58,815 $45,553 INVESTOR CONTACT:Leiv LeaChief Financial OfficerCorvus Pharmaceuticals, Inc.+1-650-900-4522llea@corvuspharma.com MEDIA CONTACT:Sheryl SeapyReal Chemistry+1-949-903-4750sseapy@realchemistry.com

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 (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 InvestorsRachel FrankIR@bicara.com MediaDan Budwick1ABdan@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, 2023Assets(Unaudited) Current assets: Cash and cash equivalents$520,758 $230,440Prepaid expenses and other assets 756 633Total current assets 521,514 231,073 Property and equipment, net 130 202Right of use asset – operating lease 414 613Other assets 2,115 2,094Total assets$524,173 $233,982 Liabilities, redeemable convertible preferred stock, and stockholders’ equity (deficit) Current liabilities: Accounts payable$1,531 $2,142Accounts payable – related party 431 1,044Accrued expenses and other current liabilities 10,410 8,053Accrued expenses and other current liabilities – related party 1,801 3,561Operating lease liability – current portion 308 285Total current liabilities 14,481 15,085 Operating lease liability – net of current portion 137 372Other liabilities — 17Total liabilities 14,618 15,474Total redeemable convertible preferred stock — 367,277