TRACON Pharmaceuticals Reports Fourth Quarter and Year-End 2022 Financial Results and Provides Corporate Update
“The significant progress we achieved in the fourth quarter sets up 2023 to be a potentially transformational year for TRACON,” said
Recent Corporate Highlights
November 2022, we announced dosing of the first patient in a Phase 1/2 trial that studies envafolimab with our proprietary CTLA-4 antibody YH001 in combination with doxorubicin in front line sarcoma.
November 2022, we completed the Phase 1 study of the CD73 antibody TJ4309, triggering I-Mab’s right to reacquire the asset for a payment to TRACON of $9M.
December 2022, we announced positive interim results in the ENVASARC Phase 2 pivotal trial based on a double-digit objective response rate (ORR) by central radiographic review in the cohort of single agent envafolimab (N=18) and the cohort of envafolimab given in combination with Yervoy (N=18). The primary endpoint of the pivotal ENVASARC trial is achievement of an 11.25% ORR by central radiographic review in either 80 patient cohort.
December 2022, we announced a non-recourse non-dilutive financing of up to $30Mrelated to the arbitration with I-Mab. We received $3.5Mup front and the remainder will be available subject to the award exceeding a threshold and satisfaction of other conditions.
Expected Upcoming Milestones
- Report the binding decision of the
International Chamber of Commerce Arbitration Panel on theongoing arbitration involving the TJ4309 and bispecific antibody agreements with I-Mab Biopharma where we are seeking to recover over $200 millionin damages, which we expect in the first quarter of 2023.
- Report the second and final interim efficacy analysis from the ENVASARC pivotal trial following the review of more than 12 weeks of efficacy data (including two on-study CT scans) by the independent data monitoring committee from 46 patients who receive envafolimab as a single agent and 46 patients who receive envafolimab in combination with Yervoy®, which we expect in the third quarter of 2023.
- Complete full accrual of the ENVASARC pivotal trial before the end of 2023.
- Report Phase 1 data from the Phase 1/2 clinical trial of YH001 in combination with envafolimab and doxorubicin in patients with soft tissue sarcoma, which we expect in the second half of 2023.
Fourth Quarter 2022 Financial Results
- Cash and cash equivalents were
$17.4 millionat December 31, 2022, compared to $24.1 millionat December 31, 2021, and is expected to fund the company into mid-2023.
- Research and development expenses for the fourth quarter of 2022 were
$3.9 million, compared to $3.1 millionfor the fourth quarter of 2021.
- General and administrative expenses for the fourth quarter of 2022 were
$2.0 million, compared to $4.6 millionfor the fourth quarter of 2021. The decrease was primarily attributable to legal expenses incurred in the fourth quarter of 2021 in connection with the arbitration with I-Mab.
- Net loss for the fourth quarter of 2022 was
$7.0 million, compared to $7.7 millionfor the fourth quarter of 2021.
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.
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
About ENVASARC (NCT04480502)
The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in
YH001 is an IgG1 antibody against CTLA-4 that has shown enhanced antibody dependent cellular cytotoxicity and complement dependent cytotoxicity in vitro. In preclinical studies YH001 demonstrated superior T cell activation and superior tumor growth inhibition activity compared to ipilimumab. YH001 also demonstrated superior activity compared to ipilimumab in human transgenic mouse tumor models when combined with a PD-(L)1 antibody. In these models, single agent YH001 depleted regulatory T cells and increased CD8+ T cells in tumor tissue. YH001 is being studied with envafolimab and doxorubicin in a Phase 1/2 clinical trial sponsored by TRACON (NCT05448820), and has been studied in multiple Phase 1 trials in
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
TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate to adenosine, which is highly immunosuppressive. TJ004309 was studied in a Phase 1 trial sponsored by TRACON (NCT03835949) 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.
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 1/2 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 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.
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 final binding decision from the
Unaudited Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
|Three Months Ended
|Research and development||3,875||3,064||13,888||11,146|
|General and administrative||1,957||4,599||14,006||17,547|
|Total operating expenses||5,832||7,663||27,894||28,693|
|Loss from operations||(5,832)||(7,663)||(27,894)||(28,347)|
|Total other expense||(1,165)||(49)||(1,241)||(320)|
Net loss per share, basic and diluted
|Weighted-average common shares outstanding,|
|basic and diluted||22,293,735||19,442,526||20,919,118||17,252,637|
Unaudited Condensed Consolidated Balance Sheets
|Cash and cash equivalents|
|Prepaid and other assets||795||864|
|Total current assets||18,228||24,936|
|Property and equipment, net||51||50|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses|
|Accrued compensation and related expenses||1,457||1,532|
|Long-term debt, current portion||9,807||1,391|
|Total current liabilities||22,371||13,676|
|Other long-term liabilities||969||1,167|
|Arbitration financing payable||3,280||—|
|Commitments and contingencies|
|Additional paid-in capital||229,737||219,471|
|Total stockholders’ equity||(7,151)||11,714|
|Total liabilities and stockholders’ equity|
|Company Contact:||Investor Contact:|
|Chief Executive Officer|
|(858) 550-0780||(212) 915-2578|
Source: TRACON Pharmaceuticals, Inc.