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TRACON Pharmaceuticals, Inc. (symbol: TCON) is a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapeutics for the treatment of cancer and wet age-related macular degeneration (AMD). The firm's leading clinical-stage product is Envafolimab (KN035), an investigational PD-L1 single-domain antibody designed for the treatment of soft tissue sarcoma.
The company's portfolio also includes:
- DE-122: Currently in a randomized Phase IIa study targeting wet AMD.
- TRC102: A small molecule in Phase II clinical trials for mesothelioma, Phase I trials for solid tumors, and additional trials for lymphomas and lung cancer.
- TRC253: In Phase II clinical trials for treating metastatic castration-resistant prostate cancer.
- TJ004309: A CD73 antibody in Phase I development for solid tumors.
TRACON Pharmaceuticals operates on a cost-efficient, contract research organization (CRO)-independent product development platform. This unique approach allows the company to partner with ex-U.S. companies, facilitating the development and commercialization of innovative therapies within the United States.
The company's collaborative efforts and licensing agreements with other firms reinforce its commitment to delivering cutting-edge treatments. Financially, TRACON demonstrates resilience and strategic growth, leveraging partnerships to advance their clinical trials and ensure a pipeline of promising therapeutic candidates.
For investors, TRACON Pharmaceuticals represents a significant opportunity in the biopharmaceutical landscape, driven by a robust pipeline of investigational drugs and a strategic focus on effective, targeted cancer therapies.
TRACON Pharmaceuticals (NASDAQ: TCON) announced a registered direct offering of 1.1 million shares at $8.06 per share, raising approximately $8.8 million. The offering, closing around December 22, 2020, aims to fund the pivotal ENVASARC study for envafolimab in sarcoma, alongside business development and general corporate purposes. A.G.P./Alliance Global Partners is the financial advisor for this transaction, conducted under an effective SEC registration statement. Investors are encouraged to review the prospectus supplement to understand the offering details.
TRACON Pharmaceuticals (NASDAQ:TCON) announced the publication of clinical data revealing insights into TRC102's mechanism and responsive patient demographics. The study highlighted a patient with metastatic colorectal cancer achieving a near-complete response for 45 months post-treatment with TRC102 and Temodar. Molecular analysis indicated that silencing of DNA repair pathways contributed to treatment effectiveness. TRC102 is currently in multiple Phase 1 and 2 trials, with promising data supporting its use in combination treatments for glioblastoma.
TRACON Pharmaceuticals (NASDAQ:TCON) announced that its partners, Alphamab Oncology and 3D Medicines, have submitted a new drug application for envafolimab (KN035) to the National Medical Products Administration (NMPA) for treating MSI-H/dMMR cancers, including colorectal and gastric cancers. This submission signifies a key milestone in envafolimab's development. The drug, a subcutaneous PD-L1 inhibitor, is also being tested in various ongoing trials, including those for biliary tract cancer and sarcoma.
TRACON Pharmaceuticals (NASDAQ:TCON) announced its Q3 2020 financial results, highlighting significant progress in its ENVASARC trial and funding acquisition. Cash reserves increased to $26.5 million, supporting operations into Q1 2022. The company reported a net loss of $4.0 million, down from $5.2 million a year earlier, while R&D expenses decreased to $1.8 million. TRACON aims to expedite patient enrollment for the ENVASARC trial and anticipates interim data in 2021. Additionally, envafolimab shows promising results in MSI-H/dMMR colorectal cancer, with a 32% objective response rate.
TRACON Pharmaceuticals (NASDAQ:TCON) will release its third quarter 2020 financial and operating results on November 10, 2020, after market close. A conference call is scheduled for the same day at 4:30 pm ET to discuss these results and corporate activities. The company's clinical pipeline includes Envafolimab for sarcoma, TRC253 for prostate cancer, TRC102 for lung cancer, and TJ004309 for advanced solid tumors. TRACON aims to partner with companies lacking U.S. clinical capabilities, sharing costs and risks in drug development.
TRACON Pharmaceuticals (NASDAQ:TCON) announced that the FDA has granted orphan drug designation for its drug TRC102, aimed at treating malignant glioma, including glioblastoma. TRC102 is a small molecule designed to inhibit the DNA base excision repair pathway. Clinical trials have shown promising results, with some patients experiencing extended survival. Orphan designation provides TRACON with incentives such as tax credits for clinical trials and seven years of market exclusivity upon approval. This designation highlights the unmet medical needs in treating malignant glioma.
TRACON Pharmaceuticals (NASDAQ:TCON) highlighted updated clinical data from the pivotal trial of envafolimab for patients with MSI-H/dMMR colorectal cancer. The trial showed a 32% confirmed objective response rate (ORR) in 41 patients, with 75% achieving a duration of response (DOR) of at least 12 months. The overall population saw a 43% ORR with 92% having a DOR of 12 months or more. Envafolimab's efficacy is comparable to immune checkpoint inhibitors Opdivo and Keytruda, and it is set for a pivotal trial in undifferentiated pleomorphic sarcoma in the U.S.
TRACON Pharmaceuticals (Nasdaq: TCON) will present a corporate overview at the H.C. Wainwright 22nd Annual Global Investment Conference on September 16, 2020, at 12:00 pm EDT. The live webcast can be accessed on their website, with a replay available afterward. TRACON focuses on targeted cancer therapeutics, utilizing a CRO-independent development platform. Their pipeline includes Envafolimab for sarcoma, TRC253 for prostate cancer, TRC102 for lung cancer, and TJ004309 for advanced solid tumors. The company seeks partnerships for U.S. regulatory and clinical development.
TRACON Pharmaceuticals (TCON) announced that CEO Charles Theuer will present a corporate overview at the 2020 Wells Fargo Virtual Healthcare Conference on September 9 at 10:40 am EDT. The company focuses on developing targeted cancer therapies and operates an efficient, CRO-independent product development platform. Its pipeline includes Envafolimab for sarcoma, TRC253 for prostate cancer, TRC102 for lung cancer, and TJ004309 for advanced solid tumors. TRACON seeks partnerships for U.S. regulatory and clinical development to share costs and risks.
TRACON Pharmaceuticals (NASDAQ: TCON) announced a definitive securities purchase agreement to raise approximately $5.0 million through a private placement of about 3.0 million shares of common stock and pre-funded warrants. Each share will be priced at approximately $1.67. The funds will be used for the ENVASARC pivotal study of envafolimab in sarcoma, cleared by the FDA on August 14, 2020, and for general corporate purposes. The company will file a registration statement with the SEC for the resale of the stock-related securities.
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