YH-001

嘉宾简介陈兆荣博士深耕医药研发行业三十余载，在新药临床研发、新药审评、医药注册，医学事务和药物安全等领域有着丰厚经验。在加入祐和前曾在Citrine Medicine, JHL等几家Biotech公司担任CMO。在GSK曾担任副总裁兼卓越注册中心负责人、中国/香港区医学总监。在此之前，他历任Bayer-Schering Pharma、Sanofi高管职位。陈兆荣博士毕业于山东医科大学医疗系，并在澳大利亚阿德莱德皇家医院获得临床药理学博士学位。他曾获阿德雷得皇家医院Florey 研究基金及NH&MRC研究基金。也曾在澳大利亚药品管理局（TGA）从事药物审评与审批工作。祐和医药作为百奥赛图的全资子公司，祐和医药承担着为百奥赛图研发管线进行临床开发的使命。依托强大的临床开发团队及其丰富的临床开发经验，祐和医药聚焦于肿瘤和非肿瘤的抗体药物治疗。公司已构建起针对十多个靶点的强大研发管线。现阶段1个产品已启动国际多中心（MRCT）II期临床研究，3个产品在临床I期，1个产品获得IND批件。详情请访问：www.eucure.com。发展历程201611月，祐和医药科技（北京）有限公司成立12月，获得百奥财富和国投创业的A轮投资20177月，获得百奥财富和国投创业的A+轮投资20183月，完成由招银国际资本领投，本草资本跟投的B轮投资20195月，成立波士顿子公司10月，组建国际化临床开发团队10月，YH001项目IND获得FDA批准2020YH001项目：①联合君实生物PD-1澳洲I期临床研究完成首例患者筛选②项目IND获得NMPA批准YH002项目：①项目IND获得FDA批准②澳洲I期临床研究完成首例患者筛选③项目IND获得NMPA批准YH003项目：联合君实生物PD-1澳洲I期临床研究完成首例患者筛选2021YH001项目：①中国I期临床研究完成首例患者筛选②和YH003在美国进入II期临床研究③II期国际多中心临床试验（MRCT）获NMPA批准YH003项目：①联合君实生物PD-1在澳洲顺利进入II期临床研究②项目IND获得NMPA批准③中国I期临床研究完成首例患者用药④II期国际多中心临床试验（MRCT）获NMPA批准⑤联合PD-1抗体的国际多中心（MRCT）II期临床试验完成首例患者给药YH004项目：澳洲I期临床研究完成首例患者给药技术平台基于RenMice®（RenMab®，RenLite®和RenNano®）平台，百奥赛图建立了六大全人抗体技术平台，满足多种靶点、多种成药形式的抗体药物开发。产品管线Innovative Drug Pipeline质量源于设计，又贯穿始终。QbD大会历经四载，在行业同仁的持续关注和支持下，2024第五届QbD生物药质量科学大会（QbD2024）将于7月26-27日在北京悠唐皇冠假日酒店再次召开。将重点围绕创新生物药的质控、分析、法规等内容展开讨论。从案例、实践去解读创新药质量研究管理的进程，持续深化QbD理念。祐和医药首席执行官&首席医学官陈兆荣将在大会会场四：国际药品监管法规专场为大家带来主题为“遵循监管政策，加速新药研发”的报告，诚邀各位同仁与会！药企福利-享免费观摩门票推荐阅读归来花满树，携手再破千层浪！金斯瑞蓬勃生物倾情加盟QbD2024第五届生物药质量科学大会茵冠生物质量总监邹沛华：间充质干细胞质量控制与质量体系的搭建 | QbD2024风云录泽辉生物质量负责人单晓鹏：细胞治疗产品控制策略 | QbD2024风云录原启生物质量副总裁陶铜静：CGT药物CMC质量控制策略 | QbD2024风云录景达生物CEO杨月峰：通用现货型NK细胞的工艺开发及质量控制 | QbD2024风云录贝思奥生物创始人罗光佐：AAV药物关键质量属性及其分析质控难点 | QbD2024风云录

SAN DIEGO, May 14, 2024 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, today announced financial results for the first quarter ended March 31, 2024. The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time. “With ENVASARC fully enrolled we are focused on leveraging our Product Development Platform to generate non-dilutive capital through either an additional license or by replacing a CRO and executing clinical trials for partners at a lower cost compared to a CRO but still at a premium to our costs using a pay for performance model,” said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. “We look forward to reporting the final response assessment data in all patients from the ENVASARC Phase 2 pivotal trial, which are expected in the third quarter.” Recent Corporate Highlights In April, we announced updated interim safety and efficacy data from the ENVASARC Phase 2 pivotal trial in 73 patients treated with single agent envafolimab. The objective response rate (ORR) was 11% by investigator review and 5.5% by blinded independent central review (BICR), all of which were confirmed responses. Envafolimab monotherapy was generally well tolerated and median duration of response by BICR was greater than six months. The primary endpoint of the study is achievement of an ORR by BICR in nine of 82 patients (11%) treated with envafolimab and median duration of response of greater than six months is a key secondary endpoint. In April, the Company announced that the Nasdaq Hearings Panel granted the Company’s request for an extension to demonstrate compliance with all applicable criteria for continued listing on The Nasdaq Capital Market, including the $1.00 bid price and $2.5 million stockholders’ equity requirements, through June 3, 2024, provided the Company execute a reverse stock split and file an S-1, both of which the Company executed in April. The Company continues to consider alternatives to address the $2.5 million stockholders’ equity requirement on or before June 3, 2024. Expected Upcoming Milestone Report the final response assessment data including duration of response in all patients from the ENVASARC Phase 2 pivotal trial, which are expected in the third quarter of 2024. First Quarter 2024 Financial Results Cash, cash equivalents and restricted cash were $8.0 million at March 31, 2024, compared to $8.6 million at December 31, 2023, which is expected to fund the Company late into the third quarter of 2024. Research and development expenses for the first quarter of 2024 were $1.9 million, compared to $5.0 million for the first quarter of 2023. The decrease was primarily related to completing enrollment of the ENVASARC Phase 2 pivotal trial in 2024. General and administrative expenses for the first quarter of 2024 were $1.4 million, compared to $2.3 million for the first quarter of 2023. Net loss for the first quarter of 2024 was $3.2 million, compared to $8.5 million for the first quarter of 2023. Conference Call Details To access the call by phone, please register using this link and you will be provided with dial-in details. A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com. After the live webcast, a replay will remain available on TRACON’s website for 60 days. About Envafolimab Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. TRACON has received orphan drug designation from the U.S. Food and Drug Administration for envafolimab for patients with soft tissue sarcoma and fast track designation from the U.S. Food and Drug Administration for envafolimab (KN035) for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy. About ENVASARC (NCT04480502) The ENVASARC Phase 2 pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON enrolled patients in ENVASARC with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor. A total of 82 evaluable patients have received treatment with single agent envafolimab at 600 mg every three weeks. The primary endpoint is objective response rate by central review in nine of 82 patients (11%) with duration of response a key secondary endpoint. About TRACON TRACON is a clinical-stage biopharmaceutical company utilizing a cost-efficient, CRO-independent, product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies. The Company’s clinical-stage pipeline includes: Envafolimab, a PD-L1 single-domain antibody given by rapid subcutaneous injection that is being studied in the pivotal ENVASARC trial for sarcoma; YH001, a potential best-in-class CTLA-4 antibody in Phase 1 development; and TRC102, a Phase 2 small molecule drug candidate for the treatment of lung cancer. TRACON is actively seeking additional corporate partnerships through a profit-share or revenue-share partnership, or through franchising TRACON’s product development platform. TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in the United States or who wish to become CRO-independent. To learn more about TRACON and its product pipeline, visit TRACON’s website at www.traconpharma.com. Forward-Looking Statements Statements made in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, TRACON’s plans to further develop product candidates; TRACON’s ability to regain compliance with Nasdaq continued listing standards and maintain the listing of its securities on a national securities exchange; TRACON’s plans to further license out its platform or replace CROs and generate non-dilutive capital; expectations regarding the timing and scope of clinical trials and availability of clinical data, including the timing and results of accrual and data from TRACON’s ENVASARC Phase 2 pivotal trial; expected development, regulatory and commercial milestones and timing thereof; potential utility of product candidates; TRACON’s cash runway; and TRACON’s business development strategy and goals, including the ability to enter into additional collaborations or licensing arrangements. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: the risk that TRACON needs substantial additional capital to continue as a going concern and to enroll or complete its ongoing clinical trials as currently planned, if at all; risks associated with clinical development and regulatory approval of novel pharmaceutical product candidates; whether TRACON or others will be able to complete or initiate clinical trials on TRACON’s expected timelines, if at all, including due to risks associated with geopolitical and macroeconomic events; the fact that future preclinical studies and clinical trials, including ENVARSAC, may not be successful or otherwise consistent with results from prior studies; the fact that TRACON has limited control over whether or when third party collaborators complete on-going trials or initiate additional trials of TRACON’s product candidates; the fact that TRACON’s collaboration agreements are subject to early termination; whether TRACON will be able to enter into additional collaboration agreements or licensing arrangements or arrangements whereby TRACON replaces CROs on favorable terms or at all; potential changes in regulatory requirements in the United States and foreign countries; TRACON’s reliance on third parties for the development of its product candidates, including the conduct of its clinical trials and manufacture of its product candidates; whether TRACON will be able to obtain additional financing; whether TRACON will experience unanticipated costs or other events that cause TRACON’s cash runway to not extend late into the third quarter of 2024; whether TRACON will remain listed on Nasdaq; and other risks described in TRACON’s filings with the Securities and Exchange Commission under the heading “Risk Factors”. All forward‐looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. TRACON undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made except as required by law. TRACON Pharmaceuticals, Inc.Unaudited Condensed Consolidated Statements of Operations(in thousands, except share and per share data) Three Months EndedMarch 31, 2024 2023 Revenue$100 $— Operating expenses: Research and development 1,878 4,969 General and administrative 1,434 2,344 Total operating expenses 3,312 7,313 Loss from operations (3,212) (7,313)Total other income (expense) 44 (1,191)Net loss$(3,168) $(8,504) Loss per share, basic and diluted$(1.33) $(6.76)Weighted-average common shares outstanding, basic and diluted 2,389,519 1,258,096 TRACON Pharmaceuticals, Inc.Unaudited Condensed Consolidated Balance Sheets(in thousands) March 31, December 31, 2024 2023 Assets Current assets: Cash and cash equivalents$7,891 $8,564 Prepaid and other assets 511 526 Total current assets 8,402 9,090 Property and equipment, net 33 37 Restricted Cash 73 73 Other assets 847 905 Total assets$9,355 $10,105 Liabilities and Stockholders’ Deficit Current liabilities: Accounts payable and accrued expenses$10,036 $9,755 Accrued compensation and related expenses 414 427 Total current liabilities 10,450 10,182 Other long-term liabilities 667 732 Commitments and contingencies Stockholders’ deficit: Common stock 3 2 Additional paid-in capital 241,902 239,688 Accumulated deficit (243,667) (240,499)Total stockholders’ deficit (1,762) (809)Total liabilities and stockholders’ deficit$9,355 $10,105 Company Contact:Investor Contact:Charles TheuerBrian RitchieChief Executive OfficerLifeSci Advisors LLC(858) 550-0780(212) 915-2578ctheuer@traconpharma.combritchie@lifesciadvisors.com