Baichi and leap therapeutics announced exclusive option and license agreement for dkn-01

Leap therapeutics and baichi today announced an exclusive option and license agreement for the clinical development and commercialization of leap therapeutics' Dickkopf-1 (DKK1) antibody dkn-01 in Asia (excluding Japan), Australia and New Zealand Baichi obtained the right to develop and commercialize the dkn-01 of leap therapeutics in Asia Pacific region (except Japan), and launched the joint study of dkn-01 of leap therapeutics and terezumab, an anti PD-1 antibody of baichi Cambridge, Ma and Beijing, China January 3, 2020 / American news agency / -- leap Therapeutics (NASDAQ Code: lptx), a biotech company developing targeted immunotumor therapy, and Baiji Shenzhou (NASDAQ Code: bgne; Hong Kong stock exchange code: 06160), a biomedical company in the commercial stage, focuses on the development and commercialization of innovative molecular targeting and immunotumor drugs for cancer treatment The two companies today announced an exclusive option and license agreement for the clinical development and commercialization of leap therapeutics' Dickkopf-1 (DKK1) antibody dkn-01 in Asia (excluding Japan), Australia and New Zealand Leap therapeutics will retain the exclusive right to develop, produce and commercialize dkn-01 in the rest of the world In addition, leap therapeutics announced a US $27 million equity financing agreement with Baiji Shenzhou and two institutional investors "We are very pleased to explore the combination therapy of anti PD-1 antibody tirelizumab and dkn-01 So far, dkn-01 has been active in combination with immunosuppressive agents in gastric cancer patients defined by biomarkers Our partnership with leap therapeutics is another example of our commitment to developing innovative therapies to meet unmet medical needs in Asia and around the world " In accordance with the terms of the agreement, leap therapeutics will receive US $3 million in cash in advance from Baekje, which will receive an exclusive license to develop and commercialize dkn-01 in Asia (excluding Japan), Australia and New Zealand Leap therapeutics will be eligible for an additional payment from baichi if baichi decides to exercise based on the results of subsequent preliminary proof of concept tests In addition, leap therapeutics is eligible to receive payments from Baiji Shenzhou based on the achievement of specific development, regulatory and sales milestones, with a total transaction value of up to $132 million, and to receive a tiered royalty on any product sold by dkn-01 in the licensed territory As part of a $27 million equity investment being made simultaneously, Baiji will make a $5 million equity investment in leap therapeutics Dr Christopher K mirabelli, President and CEO of leap therapeutics, said: "cooperation on the further development of dkn-01 has always been our primary strategic focus We are very pleased to start our cooperation with the global leader in tumor field, Baiji Shenzhou, which is leap The ideal partner of therapeutics, who has rich experience in tumor drug development in Asia Pacific region, and their expertise and products will support our efforts to meet the far unmet medical needs in esophagus, stomach, gynecology and other cancers " During the term of the option, leap therapeutics agreed to conduct a study on the combination therapy of dkn-01 and tirelizumab Leap therapeutics plans to evaluate the combination therapy of dkn-01 and tirelizumab in about 40 patients with second-line DKK1 overexpression of gastric adenocarcinoma / gastroesophageal junction cancer, in order to establish a positive clinical experience of dkn-01 combined with PD-1 inhibitors in such patients In addition, leap therapeutics plans to evaluate the efficacy of dkn-01 combined with tirelizumab and chemotherapy in about 20 patients with first-line gastric adenocarcinoma / gastroesophageal junction cancer Leap therapeutics expects to launch these clinical trials in the first half of 2020 At the same time that the equity financing and Baiji Shenzhou signed the authorization agreement, leap therapeutics has signed a securities purchase agreement to sell 1421801 newly designated series a compulsory convertible preferred shares to a major institutional investor at a price of $10.55 per share in the form of targeted additional issuance after the equity financing takes effect, and 1137 shares to Baiji Shenzhou and perception advisors, 442 newly designated series B mandatory convertible preferred shares The share price of the preferred stock is equivalent to $1.055 per common stock, which is the closing price of the common stock of leap therapeutics on the NASDAQ Global Stock Market on January 2, 2020 At the end of the transaction, holders of series a mandatory convertible preferred shares will also receive a voting special preferred share, which will give them the right to elect a member of the leap therapeutics board of directors With the approval of leap therapeutics shareholders, series a compulsory convertible preferred shares will be automatically converted into prepaid warrants to purchase 14218010 ordinary shares, Series B compulsory convertible preferred shares will be automatically converted into 11374420 ordinary shares, and the additional shares represent 8% of the accrued dividend per year Upon shareholder approval and conversion of preferred shares, investors will also receive warrants to purchase up to an equivalent number of common shares at an exercise price of $2.11 per share Before deducting the placement agency fee and expected issuance fee payable by leap therapeutics, the total income of leap therapeutics from this issuance is about 27 million USD, excluding any income from exercising the certified equity The equity financing plan will come into effect on or before January 8, 2020 if the customary transaction conditions are met Leap therapeutics plans to hold a special meeting of shareholders to approve the increase of authorized shares of common stock, conversion of convertible preferred stock to common stock, issuance of warrants and other related matters With regard to the general meeting, leap therapeutics has signed a voting agreement with the subsidiary entity of healthcare ventures, which holds 29.3% of the company's existing issued common shares in total, to vote on all its income shares and to vote in favor of the plan proposed at the special meeting of shareholders Raymond James is the placement agent for the equity financing The additional securities are not registered under the Securities Act of 1933, as amended, or under the securities laws of other states of the United States, and may not be issued or sold in the United States if they are not registered with the securities and Exchange Commission (SEC) or do not meet applicable registration exemption exceptions Leap therapeutics has agreed to file a registration statement with the securities and Exchange Commission that includes the resale of common shares converted from preferred shares and the exercise of warrants to be issued in an additional direction This press release does not constitute an offer to sell or solicit the purchase of any securities which, in any state, may not be sold in that state if such offer, solicitation and sale were illegal prior to registration or qualification under the laws of that state Dkn-01 dkn-01 is a humanized monoclonal antibody, which can bind to and block the activity of Dickkopf-1 (DKK1) protein Dickkopf-1 (DKK1) protein is the regulator of Wnt / β - Catenin signal transduction, and Wnt / β - Catenin signal is a signal pathway that usually involves tumor development and immunosuppression of the immune system DKK1 plays an important role in tumor cell signaling and immune suppressive tumor microenvironment by enhancing the activity of myeloid suppressor cells and inhibiting the effect of NK ligand on tumor cells About gastroesophageal junction / gastric adenocarcinoma the gastroesophageal junction is the junction of esophagus and stomach According to its tissue location, adenocarcinoma of the gastroesophageal junction is usually classified as esophageal cancer or gastric cancer Gastric adenocarcinoma (gastric cancer) is still one of the most common lethal cancers in the world, especially in elderly men According to GLOBOCAN 2018 data, gastric cancer is the fifth most common tumor and the third most lethal cancer, with about 783000 deaths in 2018 [II] The incidence and mortality of gastric cancer vary greatly from region to region, which is highly correlated with diet and H pylori infection [II] About leap therapeutics leap therapeutics (NASDAQ Code: lptx) focuses on the development of targeted and immunotherapy for cancer Dkn-01 is the most advanced clinical candidate drug of leap therapeutics It is a humanized monoclonal antibody against the protein of Dickkopf-1 (DKK1), a Wnt pathway regulator At present, dkn-01 is being used in clinical trials for the treatment of esophageal cancer, hepatobiliary cancer, gynecological cancer and prostate cancer For more information on leap therapeutics, please visit http:// or the public documents submitted by leap therapeutics to the U.S Securities and Exchange Commission, which can be accessed at http:// through the electronic data collection, analysis and retrieval system (EDGAR) or https://investors.leaptx.com/ About Baiji Shenzhou, a global, commercial stage, R & D-based biotechnology company, focusing on the research and development of molecular targeting and immunotherapy for tumor With more than 3300 employees in mainland China, the United States, Australia and Switzerland, Baiji Shenzhou is developing new oral small molecule and monoclonal antibody anti-cancer drugs At present, Baiji Shenzhou is also building a drug combination program for anti-cancer treatment, aiming to bring lasting and far-reaching impact on the life of cancer patients Baichi sells its own Btk inhibitor brukinsa in the United States Gamma (zebudinib); in China, its anti-pd1 antibody drug baizean ® (tirelizumab) has been approved for marketing Under the authorization of Xinji Logistics Co., Ltd (which belongs to Bristol Myers Squibb), Baiji Shenzhou will sell Abraxane ® paclitaxel for injection (albumin binding type), refumex ® (lenalidomide) and vidasha ® (azacytidine for injection) in China; under the authorization of Amgen, Baiji Shenzhou plans to sell angavi ® (xgeva ®) desurmab injection in China [II], [III] leap therapeutics forward-looking statements this press release contains forward-looking statements within the meaning of section 27a of the Securities Act of 1933, section 21e of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, involving risks and uncertainties These statements include statements about the effectiveness of equity financing, the approval of shareholders at the extraordinary general meeting of shareholders, and dkn-01's expectations for advancing, including the start, timing and design of future research, the registration of future research, the possibility of exercising future options, milestones or royalties paid by Baiji, as well as other future expectations, plans and prospects Although leap therapeutics believes that the expectations reflected in these forward-looking statements as of the date of the statement are reasonable, the forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause the actual results to differ materially from our expectations Such risks and uncertainties include, but are not limited to, the accuracy of our estimates of fees, future revenues, capital requirements and financing needs; the results, costs and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not be effectively designed or produce positive results; and we obtain and maintain Our regulatory approval capabilities for candidate drugs; the size and growth potential of our candidate drug market; our ability to continue to obtain and maintain intellectual property protection for our candidate drugs; and other risks Detailed information on factors that may cause significant differences in actual results will be included in leap Pharma