Ficerafusp alfa

Joining Zenas BioPharma on the Nasdaq today is MBX, which has also slightly upsized its offering. It’s an unusually busy Friday for biotech IPOs, with Zenas BioPharma, MBX and Bicara Therapeutics all going public with fine-tuned offerings.Of today’s three Nasdaq debuts, Bicara is set to make the biggest splash. The cancer-focused biotech is now offering 17.5 million shares at $18 apiece, a significant advance on the 11.8 million shares the company had originally expected to offer when it set out IPO plans last week.Rather than the $210 million the company had originally hoped to raise , Bicara's offering this morning should bring in around $315 million—with potentially a further $47 million to come if underwriters take up their 30-day option to buy an additional 2.6 million shares at the same price. The final share price of $18 also marks the top end of the $16-$18 range the biotech previously set out.Bicara, which will trade under the ticker "BCAX" from this morning, is seeking money to fund a pivotal phase 2/3 clinical trial of ficerafusp alfa in head and neck squamous cell carcinoma. The biotech plans to use the late-phase data to support a filing for FDA approval of its bifunctional antibody that targets EGFR and TGF-β. Zenas has also slightly increased its own offering, expecting to bring in $225 million in gross proceeds via the sale of 13.2 million shares of its public stock at $17 apiece. Underwriters also have a 30-day option to buy almost 2 million additional shares at the same price, which could reap a further $33.7 million.That potential combined total of almost $260 million marks an increase on the $208.6 million in net proceeds the biotech had originally planned to bring in by selling 11.7 million shares initially followed by 1.7 million to underwriters.Zenas’ stock will begin trading under the ticker “ZBIO” this morning.The biotech explained last month how its top priority will be funding a slate of studies of obexelimab in multiple indications, including an ongoing phase 3 trial in people with the chronic fibro-inflammatory condition immunoglobulin G4-related disease. Phase 2 trials in multiple sclerosis and systemic lupus erythematosus and a phase 2/3 study in warm autoimmune hemolytic anemia make up the rest of the slate.Obexelimab targets CD19 and FcγRIIb, mimicking the natural antigen-antibody complex to inhibit a broad B-cell population. Because the bifunctional antibody is designed to block, rather than deplete or destroy, B-cell lineage, Zenas believes chronic dosing may achieve better outcomes, over longer courses of maintenance therapy, than existing drugs. Joining Bicara and Zenas on the Nasdaq today is MBX, which has also slightly upsized its offering. The autoimmune-focused biotech started the week estimating that it would sell 8.5 million shares priced between $14 and $16 apiece.Not only has the company since settled on the top end of this price range, but it has also bumped up the overall amount of shares available in the IPO to 10.2 million. It means that instead of the $114.8 million in net proceeds that MBX was discussing on Monday, it’s now looking at $163.2 million in gross proceeds, according to a post-market release Sept. 12.The company could rake in a further $24.4 million if underwriters fully exercise their option to buy an additional 1.53 million shares.MBX’s stock is due to list on the Nasdaq this morning under the ticker “MBX,” and the company has already set out how it will use its IPO proceeds to advance its two clinical-stage candidates, including the hypoparathyroidism therapy MBX 2109. The aim is to report top-line data from a phase 2 trial in the third quarter of 2025 and then take the drug into phase 3.

BOSTON, Sept. 12, 2024 (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 the pricing of its initial public offering of 17,500,000 shares of its common stock at a public offering price of $18.00 per share. Bicara Therapeutics’ shares are expected to begin trading on the Nasdaq Global Market on September 13, 2024 under the ticker symbol “BCAX.” The offering is expected to close on September 16, 2024, subject to the satisfaction of customary closing conditions. In addition, Bicara Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 2,625,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. All of the shares of common stock are being offered by Bicara Therapeutics. Morgan Stanley, TD Cowen, Cantor and Stifel are acting as joint bookrunners for the offering. The gross proceeds to Bicara Therapeutics from the initial public offering, before deducting underwriting discounts and commissions and other offering expenses payable by Bicara Therapeutics, are expected to be approximately $315.00 million, excluding any exercise of the underwriters’ option to purchase additional shares of common stock. A registration statement relating to the shares sold in the initial public offering has been filed with the Securities and Exchange Commission and was declared effective on September 12, 2024. The offering is being made only by means of a prospectus. A copy of the final prospectus, when available, may be obtained from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, by telephone at (866) 718-1649, or by email at prospectus@morganstanley.com; TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, New York 10017, by telephone at (855) 495-9846, or by email at TD.ECM_Prospectus@tdsecurities.com; Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022 or by email at prospectus@cantor.com; or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104 by telephone at (415) 364-2720 or by email at syndprospectus@stifel.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. 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 asset, 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 initially being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need. Cautionary Note Regarding Forward-Looking Statements This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding Bicara Therapeutics’ expectations regarding the commencement of trading of its shares on the Nasdaq Global Market, the completion and timing of the closing of the offering and the anticipated gross proceeds from the offering. Forward-looking statements are based on Bicara Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to the satisfaction of customary closing conditions and the completion of the offering, and the risks inherent in biopharmaceutical product development and clinical trials. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” section of the registration statement filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Bicara Therapeutics undertakes no duty to update such information except as required under applicable law. Readers should not rely upon the information on this page as current or accurate after its publication date. Contacts InvestorsRachel Frankir@bicara.com MediaDan Budwick1ABdan@1abmedia.com