TRACON Pharmaceuticals Reports First Quarter 2022 Financial Results and Provides Corporate Update
“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,” said
Recent Corporate Highlights
- In March, we announced the amended ENVASARC protocol using a higher dose of envafolimab was approved by the FDA.
- In April, we announced the amended ENVASARC protocol was approved by internal review boards or ethic committees at each of the 30 clinical sites in the
U.S. andU.K. and that all sites were open for enrolment, with more than 10 patients enrolled.
Expected Key Upcoming Milestones
- Two interim safety reviews and the interim efficacy data review by the ENVASARC Independent Data Monitoring Committee (IDMC) in the second half of 2022.
- Initiate dosing of a Phase 1/2 clinical trial of envafolimab with our potential best in class CTLA-4 antibody YH001 as well as with doxorubicin chemotherapy in the second half of 2022.
- Report the
International Chamber of Commerce (ICC) Arbitration Panel’s binding decisions on the legal disputes involving the TJ4309 and bispecific antibody agreements withI-Mab this year. - Complete the TJ4309 Phase 1 trial permitting
I-Mab the opportunity to terminate the license for$9M this year. - Initiate dosing of a randomized Phase 2 trial of TRC102 in locally advanced non-small cell lung cancer sponsored and funded by the
National Cancer Institute this year.
First Quarter 2022 Financial Results
- Cash, cash equivalents and short-term investments were
$16.6 million atMarch 31, 2022 , compared to$24.1 million atDecember 31, 2021 . The Company expects that its current cash and cash equivalents will fund operations into 2023. - Research and development expenses for the first quarter of 2022 were
$3.0 million , compared to$2.3 million for the first quarter of 2021. - General and administrative expenses for the first quarter of 2022 were
$6.5 million , compared to$2.7 million for the first quarter of 2021. The increase was primarily attributable to legal expenses incurred due to the arbitration hearing held inFebruary 2022 withI-Mab related to the TJ4309 and bispecific antibody agreements, and the Company expects general and administrative expenses to decrease significantly for the remainder of the year. - Net loss for the first quarter of 2022 was
$9.5 million , compared to$5.1 million for the first quarter of 2021.
Conference Call Details
Domestic: | 855-779-9066 |
International: | 631-485-4859 |
Conference ID: | 8178208 |
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, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in
About ENVASARC (NCT04480502)
The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in
About YH001
YH001 is an IgG1 antibody against CTLA-4 that has shown enhanced antibody dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (
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
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.
About TRACON
TRACON develops targeted therapies for cancer utilizing a capital efficient, CRO independent, product development platform. 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; TRC102, a Phase 2 small molecule drug candidate for the treatment of lung cancer; and TJ004309, a CD73 antibody in Phase 1 development for the treatment of advanced solid tumors. TRACON is actively seeking additional corporate partnerships whereby it leads
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, statements regarding the timing of the report from the International Chamber of Commerce Arbitration Panel’s regarding the binding decisions on the legal disputes involving the TJ4309 and bispecific antibody agreements with
Unaudited Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
Three Months Ended |
||||||
2022 | 2021 | |||||
Operating expenses: | ||||||
Research and development | ||||||
General and administrative | 6,453 | 2,671 | ||||
Total operating expenses | 9,446 | 4,955 | ||||
Loss from operations | (9,446) | (4,955) | ||||
Total other expense | (27) | (109) | ||||
Net loss | ||||||
Net loss per share, basic and diluted | ||||||
Weighted-average common shares outstanding, basic and diluted | 19,608,986 | 15,479,304 | ||||
Unaudited Condensed Consolidated Balance Sheets
(in thousands)
2022 | 2021 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | |||||||
Prepaid and other assets | 653 | 864 | |||||
Total current assets | 17,293 | 24,936 | |||||
Property and equipment, net | 49 | 50 | |||||
Other assets | 1,522 | 1,571 | |||||
Total assets | |||||||
Liabilities and Stockholders’ Equity | |||||||
Current liabilities: | |||||||
Accounts payable and accrued expenses | |||||||
Accrued compensation and related expenses | 816 | 1,532 | |||||
Long-term debt, current portion | 698 | 1,391 | |||||
Total current liabilities | 14,953 | 13,676 | |||||
Other long-term liabilities | 1,121 | 1,167 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity: | |||||||
Common stock | 20 | 19 | |||||
Additional paid-in capital | 220,019 | 219,471 | |||||
Accumulated deficit | (217,249) | (207,776) | |||||
Total stockholders’ equity | 2,790 | 11,714 | |||||
Total liabilities and stockholders’ equity |
Company Contact: | Investor Contact: |
Chief Business Officer | |
(858) 251-3492 | (212) 915-2578 |
mwiggins@traconpharma.com | britchie@lifesciadvisors.com |
Source: TRACON Pharmaceuticals, Inc.