IRAK4 Inhibitor (Xunhe Pharmaceutical)

Another inflammation and immunology startup has attracted big bucks. On Thursday, Evommune announced a $115 million raise to back a pipeline anticipated to have multiple Phase 2 readouts in the next 18 months. The Series C gives fresh momentum to the Palo Alto startup’s pipeline after it stopped development of its Phase 2a drug, an IRAK4 inhibitor, in atopic dermatitis last September. The biotech quickly rebounded and has a mid-stage test ongoing — with more planned soon — for its MRGPRX2 inhibitor codenamed EVO756. The once-daily oral drug is being explored for chronic inducible urticaria, chronic spontaneous urticaria, atopic dermatitis and other indications. Evommune has a partnership with Maruho for development and commercialization of the asset in certain Asian regions. (Septerna, which went public last week , is also working on MRGPRX2.) The startup also has an IL-18-targeted fusion protein dubbed EVO301 for atopic dermatitis. It will enter Phase 2 in the first three months of next year, CEO Luis Peña told Endpoints News . The California startup licensed the asset from South Korean company AprilBio this summer for $15 million upfront and about $475 million in potential payments, an Evommune spokesperson confirmed to Endpoints at the time of the June announcement . Meanwhile, Evommune could still return to the shelved IRAK4 inhibitor, known as EVO101. An investigator-initiated trial is now testing the drug for hidradenitis suppurativa, a chronic skin condition that has attracted interest in recent years. If those data look good, Evommune might restart development. RA Capital and Sectoral Asset Management co-led the Series C, which comes 18 months after a $50 million Series B . While the new raise gives Evommune multiple years of runway, it could entertain the idea of going public, and its investor syndicate “could easily support an IPO,” Peña said. Around the middle of next year — after releasing its first batch of Phase 2 data for EVO756 in chronic inducible urticaria — could be a good time to explore the public market, Peña said. The biotech might also attract the interest of pharma acquirers, Peña said. Evommune is led by former Dermira executives, who helped take the autoimmune drug developer to a $1.1 billion sale to Eli Lilly in early 2020. “We’re more amenable to that kind of partnership as opposed to actually doing a co-development deal with a company,” Peña said. “We have such deep development expertise that we don’t really need help on that front, but if someone wants to come and bid on our programs or our company at some point, they can.” He declined to comment on whether Evommune has already received takeover proposals. He added that “you should never set up your company that way.” Peña, who was chief development officer of Dermira when Lilly bought it, formed his new startup a week after he left the Indianapolis drugmaker in 2020. The main drug from that buyout, lebrikizumab , was approved by the FDA for eczema last month. Evommune licensed the IRAK4 inhibitor and EVO756, among other programs, from Lilly.

LEXINGTON, Mass., Oct. 29, 2024 /PRNewswire/ -- Curis, Inc. ("Curis") (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, today announced that it has entered into a definitive agreement with a combination of existing and new investors for the purchase of 2,398,414 shares of its common stock in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, Curis also agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to an aggregate of 2,398,414 shares of common stock. The unregistered warrants to be issued in the concurrent private placement will have an exercise price of $4.92 per share of common stock, will be exercisable immediately and will expire five years following the issuance date. The combined purchase price for one share of common stock and the associated unregistered warrant is $5.045. Gross proceeds to Curis from the offering are expected to be approximately $12.1 million, before deducting the placement agents' fees and other offering expenses payable by Curis. Curis intends to use the net proceeds from the offering on research, development, working capital, and other general corporate purposes. The registered direct offering and concurrent private placement are each expected to close on or about October 30, 2024, subject to the satisfaction of customary closing conditions. Truist Securities and Laidlaw & Company (U.K.) Ltd. are acting as placement agents for the registered direct offering and the concurrent private placement. The shares of common stock offered in the registered direct offering (but excluding the unregistered warrants to be issued in the concurrent private placement and shares of common stock underlying the unregistered warrants) are being offered by Curis pursuant to a shelf registration statement on Form S-3 (File No. 333-276950) that was filed with the U.S. Securities and Exchange Commission ("SEC") on February 8, 2024 and declared effective by the SEC on April 12, 2024. A prospectus supplement relating to and describing the terms of the registered direct offering will be filed with the SEC and will be available on the SEC's website at . The registered direct offering is being made only by means of a prospectus and related prospectus supplement. When available, electronic copies of the prospectus supplement and the accompanying prospectus may also be obtained from Truist Securities, Inc., Attention: Prospectus Department, 3333 Peachtree Road NE, 9th floor, Atlanta, Georgia 30326, by telephone at (800) 685-4786, or by email at [email protected]; and Laidlaw & Company (U.K.) Ltd., Attention: [email protected]. The unregistered warrants are being offered in the concurrent private placement pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), provided in Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act or applicable state securities laws. Curis has agreed to file a resale registration statement with the SEC covering the resale of the shares of common stock underlying the unregistered warrants. 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 other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About Curis, Inc. Curis is a biotechnology company focused on the development of emavusertib, an orally available, small molecule IRAK4 inhibitor. Emavusertib is currently undergoing testing in the Phase 1/2 TakeAim Lymphoma study (CA-4948-101) in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL) in combination with the BTK inhibitor ibrutinib, as a monotherapy in the Phase 1/2 TakeAim Leukemia study (CA-4948-102) in patients with relapsed/refractory acute myeloid leukemia (AML) and relapsed/refractory high risk myelodysplastic syndrome (hrMDS) with either a FLT3 mutation or a splicing factor mutation (U2AF1 or SF3B2), and as a frontline combination therapy with azacitidine and venetoclax in patents with AML (CA-4948-104). Emavusertib has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of AML and MDS and from the European Commission for the treatment of PCNSL. Curis, through its 2015 collaboration with Aurigene, has the exclusive license to emavusertib (CA-4948). Curis licensed its rights to Erivedge® to Genentech, a member of the Roche Group, under which they are commercializing Erivedge® for the treatment of advanced basal cell carcinoma. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including, without limitation, any statements with respect to Curis's registered direct offering and concurrent private placement, anticipated use of proceeds, prospects for Curis and the expected closing of the registered direct offering and the concurrent private placement. Forward-looking statements may contain the words "believes," "expects," "anticipates," "plans," "intends," "seeks," "estimates," "assumes," "predicts," "projects," "targets," "will," "may," "would," "could," "should," "continue," "potential," "focus," "strategy," "mission" or similar expressions. Actual results may differ materially from those indicated by such forward-looking statements. Factors that may cause such a difference include, without limitation, risks and uncertainties related to market and other conditions, the satisfaction of customary closing conditions related to the registered direct offering and the concurrent private placement and the impact of general economic, industry or political conditions in the United States or internationally. There can be no assurance that Curis will be able to complete the registered direct offering and the concurrent private placement on the anticipated terms, or at all. You should not place undue reliance on these forward-looking statements. Additional risks and uncertainties relating to the registered direct offering, Curis and its business can be found under the caption "Risk Factors" included in Curis's Annual Report on Form 10-K for the year ended December 31, 2023, Curis's prospectus supplement to be filed with the SEC, and in other filings that Curis periodically makes with the SEC. In addition, any forward-looking statements included in this press release represent the view of Curis only as of today and should not be relied upon as representing Curis's views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by law. SOURCE Curis, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED