BTK

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

A Beigene executive is under investigation by Chinese authorities, according to several local media reports. The executive was identified as Yin Min, according to Chinese business news outlets Yicai.com and Jiemian. Yin Min joined Beigene in January 2022 as Chief Commercial Officer for Greater China. Beigene confirmed in a statement on Friday that an employee was cooperating with the ongoing investigation in China. According to Beigene's statement, it is Beigene's understanding that the investigation is not related to Beigene's activities. Prior to joining Beigene, Yin spent 15 years at Astrazeneca, where she held various positions at the UK drugmaker, including head of oncology in China. The Economic Observer newspaper reported that Yin Min had been detained for more than 48 hours by anti-smuggling authorities in the southern Chinese city of Shenzhen. The Chinese news outlet, citing multiple people familiar with the matter, said the investigation involved allegations of illegal imports during her tenure at Astrazeneca. Several Astrazeneca employees were also detained, according to the news site. Last month, Bloomberg reported that five current and former employees of AstraZeneca were detained by Shenzhen police over the summer for possibly violating data privacy laws and illegally importing unapproved drugs. Bloomberg reported at the time, citing people familiar with the matter, that the person involved was linked to Astrazeneca's oncology division. Before that, Chinese authorities in January 2022 accused some Astrazeneca employees of insurance fraud and tampering with genetic test results to get ineligible patients to take the company's EGFR inhibitor Tagrisso. The case began in Shenzhen. He oversaw Astrazeneca's golden age in China, where it enjoyed double-digit sales growth for years until two price-cutting programs began eating into revenue from the company's generics and new drugs. As for Beigene, until recently, China was the cancer specialist's main source of revenue. With the BTK inhibitor Brukinsa gaining ground in the United States and the PD-1 inhibitor Tevimbra beginning to roll out outside of China, Beigene's dependence on China is decreasing. In 2023, Beigene's product sales in China and outside China will be roughly equal. In the first six months of 2024, China accounted for 40 percent of Beigene's product sales. In July, Beigene opened its flagship biologics manufacturing and innovation center in the United States in New Jersey. Earlier this month, Beigene officially launched Tevimbra in the U.S. at a price 10% lower than Merck & Co. 's Keytruda. Although Beigene's commercial dependence on China is decreasing, the company has recently resumed disclosure of certain risk factors related to its business in China, as required by the U.S. Securities and Exchange Commission.

Roche has inked a new deal with Dyno Therapeutics to develop next-generation AAV capsids for gene therapies targeting neurological diseases, expanding the scope of an existing partnership that started in 2020. The Swiss drugmaker will pay $50 million upfront with more than $1 billion in potential milestones and royalties, according to a Thursday release . Dyno will lead design and discovery work for the capsids, with Roche set to take on capsid validation studies as well as further preclinical and clinical development. The companies did not specify which neurological conditions would be studied. The Watertown, MA-based biotech first teamed up with Roche four years ago to develop new vectors for gene therapies for CNS diseases and liver-directed treatments. That deal featured an undisclosed upfront payment and was worth up to $1.8 billion in milestones. The latest agreement gives Roche more access to Dyno’s platform and sequence design technologies. Dyno designs its capsids with a platform called CapsidMap, which makes use of DNA libraries as well as screening and AI technology. The platform is meant to make gene therapies more effective and produce capsids that can target specific organs and tissues. The biotech also has partnerships with Astellas , Sarepta Therapeutics and Novartis . As for Roche, neurology is one of three “shared priority” areas it is focusing on for R&D work. On an earnings call with the media on Wednesday, Roche pharma head Teresa Graham said the company “is very interested in neuroscience as a therapeutic area and in a number of different diseases.” The drugmaker’s current key neurology assets include the Phase 3 BTK inhibitor fenebrutinib for multiple sclerosis and the Phase 2 antibody trontinemab for Alzheimer’s.