TRACON Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Corporate Update
“Enrollment in the ENVASARC Phase 2 pivotal trial continues to be ahead of schedule and we look forward to reporting the interim efficacy analysis on the initial 36 patients in the fourth quarter, after each patient has had two on-study scans,” said
Recent Corporate Highlights
- In August, we announced that the U.S. Food and Drug Administration (FDA) approved our Investigational New Drug (IND) application for the initiation of a Phase 1/2 clinical trial of our CTLA-4 antibody YH001 in combination with envafolimab and doxorubicin for the treatment of sarcoma patients, including patients who have not received prior therapy.
- In September, we announced entry into a $35 million non-dilutive long-term debt facility with Runway Growth Finance Corp., with
$10 millionfunded at closing which extended the Company’s runway to mid-2023.
- In September, we announced that we received fast track designation from the FDA for the development of envafolimab 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.
- In October, the Independent Data Monitoring Committee (IDMC) recommended the ENVASARC Phase 2 pivotal trial proceed as planned following the review of more than 12 weeks of safety data from more than 20 patients who received the 600 mg dose of envafolimab as a single agent or in combination with Yervoy® (ipilimumab).
Expected Upcoming Milestones
- Report the interim efficacy analysis by the IDMC following the review of more than 12 weeks of efficacy data from 36 patients who received the 600 mg dose of envafolimab as a single agent or in combination with Yervoy®.
- Initiate dosing in the Phase 1/2 clinical trial of envafolimab with our potential best in class CTLA-4 antibody YH001, as well as with doxorubicin chemotherapy.
- Report the binding decision of the
International Chamber of Commerce (ICC) 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.
Third Quarter 2022 Financial Results
- Cash and cash equivalents were
$17.0 millionat September 30, 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 third quarter of 2022 were
$4.1 million, compared to $2.7 millionfor the third quarter of 2021.
- General and administrative expenses for the third quarter of 2022 were
$2.3 million, compared to $4.2 millionfor the third quarter of 2021. The decrease was primarily attributable to legal expenses incurred in the third quarter of 2021 due to the arbitration with I-Mab.
- Net loss for the third quarter of 2022 was
$6.4 million, compared to $7.0 millionfor the third 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, 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 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 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.
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 Tribunal regarding the legal disputes involving the TJ004309 and bispecific antibody agreements with I-Mab Biopharma; whether TRACON will recover any of the
Unaudited Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
|Three Months Ended
||Nine Months Ended
|Research and development||4,097||2,730||10,013||8,082|
|General and administrative||2,280||4,151||12,049||12,948|
|Total operating expenses||6,377||6,881||22,062||21,030|
|Loss from operations||(6,377||)||(6,881||)||(22,062||)||(20,684||)|
|Total other income (expense)||(58||)||(71||)||(76||)||(271||)|
Net loss per share, basic and diluted
|Weighted-average common shares outstanding, basic and diluted||21,469,977||18,533,772||20,455,877||16,514,652|
Unaudited Condensed Consolidated Balance Sheets
|Cash and cash equivalents|
|Prepaid and other assets||983||864|
|Total current assets||18,020||24,936|
|Property and equipment, net||51||50|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses|
|Accrued compensation and related expenses||1,283||1,532|
|Long-term debt, current portion||—||1,391|
|Total current liabilities||11,760||13,676|
|Other long-term liabilities||1,446||1,167|
|Long-term debt, less current portion||9,095||—|
|Commitments and contingencies|
|Additional paid-in capital||227,257||219,471|
|Total stockholders’ equity||(2,635||)||11,714|
|Total liabilities and stockholders’ equity|
|Company Contact:||Investor Contact:|
|Chief Executive Officer|
|(858) 550-0780||(212) 915-2578|
Source: TRACON Pharmaceuticals, Inc.