Bicara Therapeutics

Bicara Therapeutics

Develops targeted therapies and tumor modulators

Overview

Bicara Therapeutics develops cancer therapies that combine targeted precision treatment with tumor modulation. Their products deliver agents to cancer cells with high specificity while also adjusting the tumor environment to boost anti-cancer activity. This dual-action approach sets them apart from firms pursuing a single strategy, as they aim to both attack cancer cells and modify the tumor site through partnerships and regulatory navigation. The company’s goal is to improve patient outcomes by bringing effective, approvable therapies to market through research, trials, and eventual commercialization.

About Bicara Therapeutics

Simplify's Rating
Why Bicara Therapeutics is rated
B-
Rated B on Competitive Edge
Rated B on Growth Potential
Rated C on Differentiation

Industries

Biotechnology

Healthcare

Company Size

51-200

Company Stage

IPO

Headquarters

Cambridge, Massachusetts

Founded

2020

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Simplify's Take

What believers are saying

  • August 11, 2026 leadership reset installed Ryan Cohlhepp, Jenn Larson, and Greg Shiferman.
  • FORTIFI-HN01 has 200-plus active sites and targets mid-2027 interim data.
  • June 30, 2026 cash reached $497.3 million, funding operations into first-half 2029.

What critics are saying

  • Y-Trap's patent lawsuit and PTAB challenge threaten ficerafusp alfa exclusivity through 2027.
  • Q2 2026 operating expenses jumped to $60.0 million, pressuring a pre-revenue balance sheet.
  • Mid-2027 interim failure kills accelerated approval and leaves Bicara dependent on one asset.

What makes Bicara Therapeutics unique

  • Ficerafusp alfa pairs EGFR targeting with TGF-beta trapping, attacking tumor growth and immune suppression.
  • May 2026 data showed 31% three-year overall survival in 1L HPV-negative HNSCC.
  • Bicara selected 1500 mg weekly for Phase 3 after FDA-aligned dose selection.

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Funding

Total Funding

$825M

Above

Industry Average

Funded Over

5 Rounds

Post IPO Equity funding comparison data is currently unavailable. We're working to provide this information soon!
Post IPO Equity Funding Comparison
Coming Soon

Benefits

Hybrid Work Options

Stock Price

Growth & Insights and Company News

Headcount

6 month growth

-1%

1 year growth

0%

2 year growth

-1%
Insider Monkey
Aug 19th, 2026
Can Bicara (BCAX) commercialize Ficera? Breakthrough 3-year data faces execution risk in c-suite overhaul.

Can Bicara (BCAX) commercialize Ficera? Breakthrough 3-year data faces execution risk in c-suite overhaul. Published on August 19, 2026 at 9:56 am by maham fatima in hedge funds, news. On August 11, Bicara Therapeutics (NASDAQ:BCAX) used its second-quarter earnings call to deliver two headlines at once. CEO Claire Mazumdar announced she will step into a Vice Chair and Strategic Adviser role at the start of next year, handing the top job to President and Chief Operating Officer Ryan Cohlhepp. That handoff arrives just as the company points to fresh survival data for ficerafusp alfa, its lead drug candidate for frontline recurrent or metastatic HPV-negative head and neck cancer, and pushes its pivotal trial toward a critical readout. Bull case: Ficera's data speaks loudly. At May's ASCO meeting, Bicara presented three-year follow-up data spanning roughly 90 patients across three dose cohorts, the longest follow-up reported for any investigational agent in HPV-negative head and neck cancer. At the 1,500 milligram weekly pivotal dose, about one in three patients was still alive at three years, roughly double the survival rate seen in retrospective analyses of standard-of-care pembrolizumab in this population. Management ties that benefit to the drug's TGF-beta inhibition, which it says drives tumor penetration and immune cell infiltration rather than blocking a single pathway. Overall survival nearly doubled against the standard of care while the safety profile stayed consistent, the company said. Execution on the pivotal Phase III FORTIFI-HN01 study has kept pace. Bicara says it is on track for substantial enrollment by the end of 2026, with more than 200 sites now active, positioning the trial for a mid-2027 interim readout that could open the door to accelerated approval. The company also launched FORTIFI-FLEX, a study of an every-three-week maintenance dose built on encouraging results from an exploratory every-two-week cohort shown earlier this year, with data targeted for the time of any U.S. approval decision. Beyond the core indication, Bicara points to early proof of concept in cutaneous squamous cell carcinoma and anal canal cancer, backed by roughly $497 million in cash that management says funds operations through the first half of 2029. Bear case: A lot changes at once. The leadership overhaul goes well beyond the CEO chair. Jenn Larson took over as Chief Financial Officer the day after the call, succeeding Ivan Hyep, who had a hand in raising over $800 million for the company since its early days. Two more transitions take effect in January: Chief Development Officer Tanya Green moves into the Chief Operating Officer seat, and Chief Corporate Affairs Officer Jenna Cohen becomes Chief Business Officer. A new Chief Legal Officer and two new board members are joining as well, a lot of change concentrated in a single quarter right as the company approaches its most consequential trial milestone. The financial picture is also getting more expensive. Operating expenses rose in the second quarter of 2026 compared with a year earlier, driven by clinical operations, manufacturing costs and a larger headcount, and management expects quarter-over-quarter expenses to keep climbing for the rest of the year as it builds out medical affairs and commercial teams. All of that spending is happening before Ficera has generated a dollar of revenue, and the payoff still depends on an interim analysis that will not arrive until mid-2027, with accelerated approval described only as a potential outcome rather than a certainty. Skeptics still outnumber believers. Hedge fund ownership held flat at 24 funds in the most recent quarter, unchanged from the prior period, which points to steady rather than growing institutional conviction. Short interest sits at 20.4% of the float, a level that signals a sizable bear camp is still betting against the stock. The bet investors are making. Bicara heads into its next chapter with a differentiated survival story and a leadership team built for commercialization, but also with more moving parts than it has had at any point since going public. The three-year ASCO data set a high bar, and confirming it will fall to a management team going through its biggest shakeup yet, right as FORTIFI-HN01 approaches its mid-2027 interim analysis. Rising spend and a crowded transition timeline give skeptics plenty to point to, even as the underlying science keeps drawing attention. Whether the drug's mechanism translates into an approved therapy, rather than just a compelling conference presentation, is the question the next several quarters will answer. While we acknowledge the risk and potential of BCAX as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. If you are looking for an AI stock that is more promising than BCAX and that has 10,000% upside potential, check out our report about this cheapest AI stock.

Yahoo Finance
Aug 11th, 2026
Bicara Therapeutics elevates Ryan Cohlhepp to CEO as pivotal head and neck cancer trial nears

Bicara Therapeutics announced a leadership transition, promoting Ryan Cohlhepp to CEO effective January 2027 as the company prepares for potential commercial launch. The biotech firm is advancing its Phase III FORTIFI-HN01 study for HPV-negative head and neck cancer, targeting substantial enrolment by year-end. Three-year follow-up data presented at ASCO 2026 showed TGF-beta inhibition nearly doubled overall survival compared to standard pembrolizumab treatment in the pivotal dose cohort. The company has expanded to over 200 active clinical sites and launched the FORTIFI-FLEX study to optimise dosing regimens. Bicara ended the quarter with $497 million in cash, expected to fund operations into the first half of 2029. Management anticipates a top-line interim analysis in mid-2027 and plans to release early colorectal cancer data by year-end 2026.

Associated Press
Aug 11th, 2026
Bicara appoints Ryan Cohlhepp as CEO, expects mid-2027 trial results for cancer therapy ficerafusp alfa

Bicara Therapeutics announced leadership changes alongside its second quarter 2026 results. Ryan Cohlhepp will succeed Claire Mazumdar as chief executive officer in January 2027, whilst Mazumdar transitions to vice chair of the board and strategic adviser. The clinical-stage biopharmaceutical company reported cash and marketable securities of $497.3 million as of 30 June 2026, up from $414.8 million at year-end 2025. Bicara expects this to fund operations into the first half of 2029. Net loss totalled $55.4 million for the second quarter, compared to $27.4 million in the same period last year. Research and development expenses nearly doubled to $45.8 million from $24.8 million, primarily due to costs for the ongoing FORTIFI-HN01 pivotal trial. The company is on track for substantial enrolment in its pivotal study by year-end, with topline interim results expected mid-2027.

MarketBeat
Aug 11th, 2026
Bicara Therapeutics (NASDAQ:BCAX) posts earnings results, hits expectations.

Bicara Therapeutics (NASDAQ:BCAX) posts earnings results, hits expectations. August 11, 2026 Key points. * Bicara Therapeutics met earnings expectations, reporting a quarterly loss of $0.82 per share, in line with the consensus estimate. * Management highlighted encouraging three-year FICERA follow-up data in HPV-negative head and neck cancer and said the pivotal FORTIFI-HN01 trial remains on track for substantial enrollment by year-end, with an interim analysis planned for mid-2027. * The company ended the quarter with approximately $497 million in cash and marketable securities, providing projected runway into the first half of 2029, though expenses are expected to rise as clinical, manufacturing, and potential commercial-launch investments increase. * Five stocks we like better than Bicara Therapeutics. Bicara Therapeutics (NASDAQ:BCAX - Get Free Report) announced its quarterly earnings results on Tuesday. The company reported ($0.82) earnings per share for the quarter, meeting the consensus estimate of ($0.82), Zacks reports. Here are the key takeaways from Bicara Therapeutics' conference call: * Management highlighted three-year follow-up data for FICERA in HPV-negative head and neck cancer, saying approximately one in three patients remained alive at three years - nearly double retrospective standard-of-care estimates - while maintaining a consistent safety profile. * The pivotal FORTIFI-HN01 study remains on track for substantial enrollment by year-end, with more than 200 sites active and a planned interim analysis in mid-2027 that could support a potential accelerated approval. * Bicara initiated the FORTIFI-FLEX study to evaluate loading and every-three-week maintenance dosing, aiming to have data available by a potential U.S. approval and support inclusion of a more convenient regimen in the product label. * The company reported approximately $497 million in cash and marketable securities at quarter-end, providing projected runway into the first half of 2029, while warning that operating expenses will rise as pivotal-trial, manufacturing, medical-affairs, and commercial-launch investments increase. * Leadership transitions will take effect as Ryan Cohlhepp becomes CEO and Claire Mazumdar moves to vice chair and strategic advisor; Bicara also announced new finance, operations, business, and legal leadership intended to support potential commercialization. Bicara Therapeutics price performance. Shares of BCAX stock traded down $3.53 during trading hours on Tuesday, reaching $24.20. 402,159 shares of the company traded hands, compared to its average volume of 596,974. The firm has a 50-day moving average price of $25.82 and a 200 day moving average price of $21.64. The company has a market cap of $1.59 billion, a P/E ratio of -8.68 and a beta of -0.75. Bicara Therapeutics has a 12-month low of $9.67 and a 12-month high of $30.99. Analyst upgrades and downgrades. A number of brokerages have recently issued reports on BCAX. The Goldman Sachs Group upped their price target on Bicara Therapeutics from $16.00 to $18.00 and gave the company a "neutral" rating in a report on Tuesday, May 12th. Guggenheim began coverage on Bicara Therapeutics in a research report on Monday, May 11th. They issued a "buy" rating and a $42.00 target price for the company. Cantor Fitzgerald restated an "overweight" rating on shares of Bicara Therapeutics in a research note on Wednesday, May 27th. Weiss Ratings reiterated a "sell (d-)" rating on shares of Bicara Therapeutics in a research note on Monday, July 6th. Finally, Morgan Stanley increased their price objective on shares of Bicara Therapeutics from $36.00 to $37.00 and gave the company an "overweight" rating in a research report on Tuesday, May 12th. One analyst has rated the stock with a Strong Buy rating, ten have issued a Buy rating, three have issued a Hold rating and one has given a Sell rating to the company's stock. According to MarketBeat.com, Bicara Therapeutics currently has a consensus rating of "Moderate Buy" and an average price target of $30.27. Insiders place their bets. In related news, COO Ryan Cohlhepp sold 28,214 shares of the company's stock in a transaction on Wednesday, July 8th. The shares were sold at an average price of $28.98, for a total value of $817,641.72. Following the completion of the transaction, the chief operating officer owned 182,177 shares of the company's stock, valued at approximately $5,279,489.46. This represents a 13.41% decrease in their position. The sale was disclosed in a filing with the SEC, which is accessible through this link. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, CEO Claire Mazumdar sold 10,000 shares of the company's stock in a transaction dated Friday, July 10th. The stock was sold at an average price of $28.42, for a total value of $284,200.00. Following the completion of the transaction, the chief executive officer directly owned 362,152 shares of the company's stock, valued at approximately $10,292,359.84. This trade represents a 2.69% decrease in their position. The disclosure for this sale is available in the SEC filing. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. In the last 90 days, insiders have sold 88,450 shares of company stock worth $2,366,675. Company insiders own 13.80% of the company's stock. Hedge funds weigh in on Bicara Therapeutics. A number of institutional investors and hedge funds have recently made changes to their positions in BCAX. Deutsche Bank AG increased its position in Bicara Therapeutics by 0.9% during the fourth quarter. Deutsche Bank AG now owns 128,626 shares of the company's stock valued at $2,165,000 after acquiring an additional 1,171 shares during the last quarter. Legal & General Group Plc lifted its holdings in shares of Bicara Therapeutics by 64.1% in the 2nd quarter. Legal & General Group Plc now owns 3,156 shares of the company's stock worth $29,000 after acquiring an additional 1,233 shares during the last quarter. Mariner LLC lifted its holdings in shares of Bicara Therapeutics by 3.0% in the 4th quarter. Mariner LLC now owns 64,562 shares of the company's stock worth $1,087,000 after acquiring an additional 1,902 shares during the last quarter. Invesco Ltd. boosted its stake in shares of Bicara Therapeutics by 13.2% during the 2nd quarter. Invesco Ltd. now owns 16,877 shares of the company's stock worth $157,000 after purchasing an additional 1,962 shares during the period. Finally, New York State Common Retirement Fund boosted its stake in shares of Bicara Therapeutics by 87.5% during the 4th quarter. New York State Common Retirement Fund now owns 7,500 shares of the company's stock worth $126,000 after purchasing an additional 3,500 shares during the period. About Bicara Therapeutics. Bicara Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing novel neurohormone-based therapies for psychiatric and neurological disorders. The company's research focuses on harnessing endogenous signaling pathways in the brain, with the goal of offering new treatment options for conditions that remain inadequately addressed by existing medications. Bicara applies proprietary peptide engineering and intranasal delivery platforms to optimize central nervous system uptake and therapeutic effect. The company's lead candidates include PST-001, an intranasal vasopressin-1A receptor antagonist in development for postpartum depression, and PST-002, an oxytocin receptor modulator being investigated for social anxiety and autism spectrum disorder. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. Continue following MarketBeat Before you consider Bicara Therapeutics, you'll want to hear this. MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and Bicara Therapeutics wasn't on the list. While Bicara Therapeutics currently has a Moderate Buy rating among analysts, top-rated analysts believe these five stocks are better buys. Learn the basics of options trading and how to use them to boost returns and manage risk with this free report from MarketBeat. Click the link below to get your free copy.

Citybiz
Jul 28th, 2026
Bicara Therapeutics adds Jeremy Bender and Christy Oliger to board as commercialization nears.

Bicara Therapeutics adds Jeremy Bender and Christy Oliger to board as commercialization nears. July 28, 2026 Bicara Therapeutics (Nasdaq: BCAX) has appointed biotechnology executives Jeremy Bender and Christy Oliger to its Board of Directors, strengthening its leadership team as the clinical-stage oncology company prepares for its next phase of growth and advances its lead cancer therapy toward potential commercialization. The appointments bring decades of biotechnology, corporate strategy, and commercial leadership experience to the board as Bicara works to transition from a clinical-stage organization to one focused on bringing its lead candidate, ficerafusp alfa, to market. The company also announced that founding board member Kiran Mazumdar-Shaw has retired from the board. Chief Executive Officer Claire Mazumdar said the additions align with Bicara's evolution as it advances its oncology pipeline. "We are delighted to welcome Jeremy and Christy to our Board of Directors at this pivotal time for Bicara," Mazumdar said. "Together, they bring deep commercial, strategic, and operational expertise that will be invaluable as we continue our evolution from a clinical-stage organization to one focused on successfully delivering ficerafusp alfa to patients." Bender most recently served as chief executive officer, president, and a director of Day One Biopharmaceuticals, leading the company through its transformation into a commercial-stage oncology business. During his tenure, Day One secured approval and launched OJEMDA for pediatric low-grade glioma before being acquired by Servier in a transaction valued at approximately $2.5 billion in 2026. His previous leadership roles include vice president of corporate development at Gilead Sciences, chief operating officer of Tizona Therapeutics, chief business officer at Sutro Biopharma, and vice president of corporate development at Allos Therapeutics. Earlier in his career, he worked in the life sciences practice at Boston Consulting Group. Bender currently serves on the boards of Mereo BioPharma Group and Aura Biosciences. Oliger brings more than 30 years of commercial and operational experience across global biopharmaceutical organizations. She most recently served as senior vice president and head of Genentech's Oncology Business Unit, where she managed a portfolio of 15 oncology products generating more than $13 billion in U.S. revenue and led an organization of more than 800 employees. During her tenure at Genentech, she oversaw multiple oncology product launches spanning lung cancer, breast cancer, chronic lymphocytic leukemia, non-Hodgkin lymphoma, and melanoma. She also previously led the company's Neurology, Rare Disease, and Infectious Disease business unit, supporting launches of Ocrevus for multiple sclerosis, Hemlibra for hemophilia, and Evrysdi for spinal muscular atrophy. Oliger currently serves on the boards of Vera Therapeutics, Karyopharm Therapeutics, and Replimune. She has also served as a director for several biotechnology companies that were later acquired, including Nuvalent, Sierra Oncology, Reata Pharmaceuticals, RayzeBio, and Lava Oncology. Board Chairman Mike Powell thanked outgoing director Kiran Mazumdar-Shaw for her role in establishing and growing the company. "As one of our founding Board members, Kiran has been instrumental in shaping Bicara from its earliest days," Powell said. "Her impact extends beyond the initial seed capital that helped launch the company, but also the strategic guidance and steadfast support that has enabled Bicara to advance ficerafusp alfa into the clinic and reach the important milestone of a registration-enabling clinical study." Bicara is developing bifunctional antibody therapies designed to simultaneously target tumor cells and modify the tumor microenvironment. Its lead candidate, ficerafusp alfa, combines an epidermal growth factor receptor (EGFR)-targeting monoclonal antibody with a transforming growth factor beta (TGF-β) ligand trap, aiming to block tumor growth while reducing immune suppression within the tumor microenvironment. The therapy is currently being developed for head and neck squamous cell carcinoma, with additional evaluation in other solid tumor types. By adding executives with extensive experience in late-stage development, commercialization, and corporate strategy, Bicara is positioning its board to support regulatory execution, potential product launches, and long-term corporate growth as its pipeline advances.

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