TRACON Pharmaceuticals

TRACON Pharmaceuticals, Inc. engages in the development and commercialization of targeted therapies for cancer, and ophthalmic and fibrotic diseases. Its products include TRC105, an anti-endoglin antibody for the treatment of solid tumor types, TRC205 created for the treatment of fibrotic diseases, and TRC102, a small molecule that is in clinical development made for lung cancer and glioblastoma. The company was founded in October 2004 and is headquartered in San Diego, CA.

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TRACON Pharmaceuticals reports positive interim data, focuses on growth strategies

TRACON Pharmaceuticals showcased promising interim data from the ENVASARC trial, reflecting positive efficacy of ENVA treatment and strategic advancements in product development.
While facing challenges such as financial losses and regulatory compliance, TRACON's focus on cost-saving measures and operational efficiency positions it for sustainable growth.
The company's strong cash position, commitment to advancing its pipeline, and opportunities for collaboration and portfolio expansion signal a promising outlook for future growth and innovation.
By leveraging its product development platform and upcoming trial data releases, TRACON aims to drive value creation, financial stability, and regulatory compliance in the competitive pharmaceutical landscape.

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TRACON Pharmaceuticals Inc (NASDAQ:TCON) announced that its undifferentiated pleomorphic sarcoma (UPS) drug envafolimab has been granted fast track designation by the US Food and Drug Administration. The designation covers the development of envafolimab for patients with locally advanced, unresectable or metastatic UPS and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy.

TRACON Pharmaceuticals earns FDA fast track designation for sarcoma drug envafolimab

SAN DIEGO, Sept. 14, 2022 (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, announced today that the U.S. Food and Drug Administration (FDA) has granted fast track designation for the development of 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.

TRACON Pharmaceuticals Announces Fast Track Designation by the FDA for Envafolimab for the Treatment of the Soft Tissue Sarcoma Subtypes of UPS and MFS

TRACON Pharmaceuticals Inc (NASDAQ:TCON) has announced a $35 million non-dilutive long-term debt facility with Runway Growth Capital LLC to support its ongoing pivotal ENVASARC trial to treat cancer and for general corporate purposes. The biopharma said that $10 million of the $35 million loan was funded upon closing, and the additional $25 million available may be funded upon achieving "certain clinical milestones and at Runway's discretion".

TRACON Pharmaceuticals strikes $35M debt financing facility with Runway Growth Capital

Initial $10 million draw extends cash runway to mid-2023 Initial $10 million draw extends cash runway to mid-2023

TRACON Pharmaceuticals Announces $35 Million Non-Dilutive Debt Financing with Runway Growth Capital

BEIJING & SAN DIEGO--(BUSINESS WIRE)-- #Biocytogen--Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen") and TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), today jointly announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for the initiation of a Phase 1/2 clinical study of YH001 in combination with envafolimab and doxorubicin for the treatment of sarcoma patients, including patients who have not received prior therapy. The Phase 1/2 tr

US FDA Approval of IND for CTLA-4 Antibody YH001 for the Treatment of Front-line Sarcoma Patients in Combination with Envafolimab

TRACON Pharmaceuticals Inc (NASDAQ:TCON) said the US Food and Drug Administration (FDA) has approved its Investigational New Drug application for the initiation of a phase one-two clinical trial of YH001 in combination with envafolimab and doxorubicin for the treatment of sarcoma, including in patients who have not received prior therapy. The trial will assess the safety and efficacy of YH001 and envafolimab in patients with the rare sarcoma subtypes of alveolar soft part sarcoma and chondrosarcoma.

TRACON Pharmaceuticals announces FDA approval for CTLA-4 antibody YH001 for treating sarcoma in combination with envafolimab

SAN DIEGO, Aug. 29, 2022 (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 that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for the initiation of a Phase 1/2 clinical trial of YH001 in combination with envafolimab and doxorubicin for the treatment of sarcoma patients, including patients who have not received prior therapy.

TRACON Pharmaceuticals Announces Approval of IND for CTLA-4 Antibody YH001 for the Treatment of Front-line Sarcoma Patients in Combination with Envafolimab

TRACON Pharmaceuticals, Inc. (NASDAQ:TCON ) Q2 2022 Earnings Conference Call August 10, 2022 4:30 PM ET Company Participants Charles Theuer - President and Chief Executive Officer Scott Brown - Chief Financial Officer Conference Call Participants Maury Raycroft - Jefferies Ed White - H.C. Wainwright Soumit Roy - Jones Research Nick Abbott - Wells Fargo Joel Beatty - Baird Operator Good day, ladies and gentlemen, and welcome to TRACON Pharmaceuticals Second Quarter 2022 Earnings Conference Call.

TRACON Pharmaceuticals, Inc. (TCON) CEO Charles Theuer on Q2 2022 Results - Earnings Call Transcript

TRACON Pharmaceuticals (NASDAQ:TCON) Inc rounded out the second quarter with a strong cash runway to carry out key trials and continue hitting significant milestones. The San Diego, Califoria-based clinical stage biopharma company reported cash and cash equivalents of US$13.6 million as of June 30 2022, compared to $24.1 million at the end of December 2021.

TRACON Pharmaceuticals ends 2Q with strong cash runway to support key trials

SAN DIEGO, Aug. 10, 2022 (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 second quarter ended June 30, 2022. The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

TRACON Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Corporate Update

TRACON Pharmaceuticals (NASDAQ:TCON) Inc announced that the Independent Data Monitoring Committee for the ENVASARC pivotal trial has recommended that the trial proceed as planned. The update follows a review of three-week safety data from more than 20 patients enrolled into the trial by the end of June 2022.

TRACON Pharmaceuticals says ENVASARC trial gets recommendation to proceed as planned

Trial to Continue as Planned Trial to Continue as Planned

TRACON Pharmaceuticals Announces Results of Independent Data Monitoring Committee Review of Safety Data from ENVASARC Pivotal Trial

TRACON Pharmaceuticals (NASDAQ:TCON) Inc announced that it has submitted an application to initiate a trial combining a new drug to be taken in combination with two other medications by patients with various types of tumours. Tracon said it has filed an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for the initiation of a phase one and two clinical study of CTLA-4 antibody YH001 in combination with envafolimab and doxorubicin for front-line patients with sarcomas, including those who have not previously received therapy.

TRACON Pharmaceuticals submits new drug application for the treatment of sarcoma patients in combination with envafolimab

SAN DIEGO, Aug. 08, 2022 (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 that the company submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1/2 clinical study of YH001 in combination with envafolimab and doxorubicin for the treatment of sarcoma patients, including patients who have not received prior therapy.

TRACON Pharmaceuticals Announces Submission of IND Application for CTLA-4 Antibody YH001 for the Treatment of Front-line Sarcoma Patients in Combination with Envafolimab

SAN DIEGO, July 27, 2022 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (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, announced today that it will report its second quarter 2022 financial and operating results after the close of U.S. financial markets on Wednesday, August 10, 2022. In addition, management will host a conference call to provide an update on corporate activities and discuss the financial results.

TRACON to Report Second Quarter 2022 Financial Results and Provide Corporate Update on August 10, 2022

TRACON Pharmaceuticals (NASDAQ:TCON) Inc said an initial independent data monitoring committee (IDMC) interim efficacy analysis of its ENVASARC pivotal trial is set to take place in 4Q following the enrollment of the 36th patient in the trial. The trial, which began dosing in December 2020, is a multicenter, open label, randomized, non-comparative, parallel cohort study targeting sarcoma being conducted at 30 top cancer centers in the United States and the United Kingdom.

TRACON Pharmaceuticals enrols 36th patient at ENVASARC trial triggering 4Q interim efficacy analysis

SAN DIEGO, July 26, 2022 (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 the enrollment of the 36th patient in the ENVASARC pivotal trial at the 600 mg dose of envafolimab, which enables the initial independent data monitoring committee (IDMC) interim efficacy analysis to proceed. The interim analysis is expected to occur in the fourth quarter of this year.

TRACON Pharmaceuticals Announces Dosing of 36th Patient in ENVASARC Pivotal Trial Triggering Initial IDMC Efficacy Review Expected in the Fourth Quarter

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SAN DIEGO, May 16, 2022 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (Nasdaq: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with life science companies through a profit-share, revenue share, or franchise model, today announced that Charles Theuer, M.D., Ph.D., President and Chief Executive Officer, will present a corporate overview at the H.C. Wainwright Global Investment Conference, being held May 23-26, 2022.

TRACON Pharmaceuticals to Present at the H.C. Wainwright Global Investment Conference

TRACON Pharmaceuticals, Inc. (NASDAQ:TCON ) Q1 2022 Earnings Conference Call May 11, 2022 4:30 PM ET Company Participants Charles Theuer – President and Chief Executive Officer Scott Brown – Chief Financial Officer Conference Call Participants Maury Raycroft – Jefferies Ed White – H.C. Wainwright Joel Beatty – Baird Nick Abbott – Wells Fargo Soumit Roy – Jones Research Operator Good day, ladies and gentlemen, and welcome to TRACON Pharmaceuticals First Quarter 2022 Earnings Conference Call.

TRACON Pharmaceuticals, Inc. (TCON) CEO Charles Theuer on Q1 2022 Results - Earnings Call Transcript

TRACON Pharmaceuticals (NASDAQ:TCON) Inc CEO Charles Theuer said the biopharmaceutical company remains on track to release interim efficacy data from its recently approved amended ENVASARC protocol, using a higher dose of envafolimab, later this year. “We are pleased with the pace of enrollment under the amended ENVASARC protocol and remain on track to deliver interim efficacy data in the second half of this year,” Theuer said in a statement accompanying the firm's 1Q results.

TRACON Pharmaceuticals says it is on track to release new efficacy data from ENVASARC protocol later this year

SAN DIEGO, May 11, 2022 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals, Inc. (Nasdaq:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with companies to develop and commercialize innovative products in the U.S., today announced financial results for the first quarter ended March 31, 2022. The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

TRACON Pharmaceuticals Reports First Quarter 2022 Financial Results and Provides Corporate Update

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SAN DIEGO, May 04, 2022 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (Nasdaq: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the United States, announced today that it will report its first quarter 2022 financial and operating results after the close of U.S. financial markets on Wednesday, May 11, 2022. In addition, management will host a conference call to provide an update on corporate activities and discuss the financial results.

TRACON to Report First Quarter 2022 Financial Results and Corporate Update on May 11, 2022

TRACON Pharmaceuticals (NASDAQ:TCON) Inc announced that the amended ENVASARC protocol approved by the US Food and Drug Administration (FDA) in February has now been approved by institutional review boards or ethics committees at all 30 of its clinical sites, including 29 in the US and one in the UK. The San Diego-based clinical stage biopharmaceutical company said it expects to report results of Independent Data Monitoring Committee (IDMC) mandated interim safety reviews and interim efficacy review in the second half of 2022.

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