TRACON Pharmaceuticals Reports Fourth Quarter and Year-End 2020 Financial Results and Provides Corporate Update
“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
Recent Corporate Highlights
- 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.
January 2021, TRACON announced that its partners Alphamab Oncology and 3D Medicines received notification their New Drug Application for envafolimab, submitted in November 2020in 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.
December 2020, TRACON announced the dosing of the first patient in the pivotal ENVASARC trial.
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.
December 2020, TRACON announced financings of approximately $13.8 millionin 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
Chinafor MSI-H/dMMR cancer.
Fourth Quarter 2020 Financial Results
- Cash, cash equivalents and short-term investments were
$36.1 millionat December 31, 2020, compared to $16.4 millionat 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 millionfor the fourth quarter of 2019.
- General and administrative expenses for the fourth quarter of 2020 were
$2.0 million, compared to $1.9 millionfor the fourth quarter of 2019.
- Net loss for the fourth quarter of 2020 was
$4.3 million, compared to $4.0 millionfor the fourth quarter of 2019.
Conference Call 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 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
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
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 (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.
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; TRC253, a Phase 3 ready small molecule drug candidate for the treatment of prostate cancer; 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
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 TRACON's and its collaboration partners’ plans to further develop product candidates, expectations regarding the timing and scope of clinical trials and availability of clinical data, expected development, regulatory and commercial milestones and timing thereof, estimated cash runway, potential utility of product candidates, potential events under collaboration and license agreements, and TRACON’s business development strategy and goals to enter into additional collaborations. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: risks associated with clinical development and regulatory approval of novel pharmaceutical products; whether TRACON or others will be able to complete or initiate clinical trials on TRACON’s expected timelines, if at all, including due to risks associated with the COVID-19 pandemic; the fact that future preclinical studies and clinical trials may not be successful or otherwise consistent with results from prior studies; the fact that TRACON has limited control over whether or when third party collaborators complete on-going trials or initiate additional trials of TRACON’s product candidates; the fact that TRACON’s collaboration agreements are subject to early termination; whether TRACON will be able to enter into additional collaboration agreements on favorable terms or at all; potential changes in regulatory requirements in
Unaudited Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
|Three Months Ended
|Research and development||$||2,197||$||1,913||$||8,198||$||14,530|
|General and administrative||1,980||1,899||8,025||7,766|
|Total operating expenses||4,177||3,812||16,223||22,296|
|Loss from operations||(4,177||)||(3,812||)||(16,223||)||(22,296||)|
|Total other expense||(134||)||(124||)||(552||)||(378||)|
|Net loss per share, basic and diluted||$||(0.31||)||$||(1.25||)||$||(1.87||)||$||(7.47||)|
|Weighted-average common shares outstanding, basic and diluted||13,800,771||3,159,740||8,984,148||3,034,299|
Unaudited Condensed Consolidated Balance Sheets
|Cash and cash equivalents||$||32,131||$||16,412|
|Prepaid and other assets||784||848|
|Total current assets||36,914||17,260|
|Property and equipment, net||16||23|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses||$||6,235||$||7,875|
|Accrued compensation and related expenses||1,590||1,355|
|Long-term debt, current portion||2,718||2,604|
|Total current liabilities||10,543||11,834|
|Other long-term liabilities||432||850|
|Long-term debt, less current portion||1,391||2,739|
|Commitments and contingencies|
|Additional paid-in capital||204,166||165,028|
|Total stockholders’ equity||25,072||2,698|
|Total liabilities and stockholders’ equity||$||37,438||$||18,121|
|Company Contact:||Investor Contact:|
|Chief Business Officer|
Source: TRACON Pharmaceuticals, Inc.