On February 25, 2021 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 U.S., reported financial results for the fourth quarter and year ended December 31, 2020 (Press release, Tracon Pharmaceuticals, FEB 25, 2021, View Source [SID1234575640]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

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"We ended 2020 on a high note by enrolling the first patient in the ENVASARC pivotal trial within one year of licensing envafolimab and raising additional capital at market price that further extends our cash runway into the second half of 2022," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We are focused on enrolling the ENVASARC trial expeditiously and expect the availability of interim data later this year, final data in 2022, and assuming positive clinical data and regulatory approval, to potentially commercialize envafolimab in 2023, in order to address a high unmet need for patients with UPS or MFS."

Recent Corporate Highlights

Envafolimab

As of February 5, 2021, TRACON had initiated 16 clinical sites and enrolled multiple patients at multiple sites in the pivotal ENVASARC trial of single agent envafolimab and envafolimab combined with Yervoy.

In January 2021, TRACON announced that its partners Alphamab Oncology and 3D Medicines received notification their New Drug Application for envafolimab, submitted in November 2020 in China, was granted priority review by the Center for Drug Evaluation of the National Medical Products Administration in the indication of MSI-H/dMMR cancer.

In December 2020, TRACON announced the dosing of the first patient in the pivotal ENVASARC trial.
TRC102

In November 2020, TRACON announced the publication of clinical data in the journal Cancer Cell, that provided molecular insight into TRC102’s mechanism of action and patient populations most likely to respond to treatment. The article, entitled, "Molecular Features of Cancers Exhibiting Exceptional Responses to Treatment," highlighted the clinical features and tumor biology of an exceptional responder patient treated with TRC102. TRC102 is a small molecule inhibitor of DNA base inhibitor repair being studied in Phase 1 and Phase 2 trials sponsored by the National Cancer Institute.
Corporate

In December 2020, TRACON announced financings of approximately $13.8 million in the aggregate with multiple new and existing healthcare focused institutional investors through registered direct offerings of its common stock. The financings were completed at market price, and TRACON expects the net proceeds will extend its cash runway into the second half of 2022.
Expected Key Upcoming Milestones

Independent Data Monitoring Committee review of ENVASARC safety data in 1H 2021.

Submit envafolimab response data to the FDA for orphan drug designation in sarcoma in 1H 2021.

Data presentation on TJ004309 Phase 1 results in 1H 2021.

Interim ENVASARC efficacy and safety data in 2H 2021.

Data presentation on TRC102 Phase 2 results in 2H 2021.

Request FDA breakthrough therapy designation for envafolimab in 2H 2021.

Decision on envafolimab NDA in China for MSI-H/dMMR cancer.
Fourth Quarter 2020 Financial Results

Cash, cash equivalents and short-term investments were $36.1 million at December 31, 2020, compared to $16.4 million at December 31, 2019. The Company expects that its current cash, cash equivalents and short-term investments will fund operations into the second half of 2022.

Research and development expenses for the fourth quarter of 2020 were $2.2 million, compared to $1.9 million for the fourth quarter of 2019.

General and administrative expenses for the fourth quarter of 2020 were $2.0 million, compared to $1.9 million for the fourth quarter of 2019.

Net loss for the fourth quarter of 2020 was $4.3 million, compared to $4.0 million for the fourth quarter of 2019.
Conference Call Details

Thursday, February 25, at 4:30 PM Eastern Time / 1:30 PM Pacific Time
Domestic: 855-779-9066
International: 631-485-4859
Conference ID: 5681569
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 novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in pivotal trials. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the U.S. sponsored by TRACON, as well as in a Phase 2 pivotal trial as a single agent in MSI-H/dMMR advanced solid tumor patients 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. Alphamab Oncology and 3D Medicines submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer that was accepted for review in December 2020 and granted priority review in January 2021. In the Phase 2 MSI-H/dMMR advanced solid tumor trial, the confirmed objective response rate (ORR) by blinded independent central review in MSI-H/dMMR colorectal cancer (CRC) patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 32%, which was similar to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 33% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of KEYNOTE-164.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multi-center, open label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States that began dosing in December 2020. TRACON expects the trial to enroll 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy. The primary endpoint is ORR by blinded independent central review with duration of response a key secondary endpoint.

About TRC102

TRC102 (methoxyamine) is a novel, small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA) and has orphan drug designation from the US FDA in malignant glioma, including glioblastoma.

About TJ004309

TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJ004309 is currently being studied in an ongoing Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.