TRACON Pharmaceuticals Reports First Quarter 2020 Financial Results and Provides Corporate Update
Recent Corporate Highlights
- In May, TRACON completed a Type B meeting with the FDA to discuss the pivotal ENVASARC trial design for the potential registration of envafolimab in multiple soft tissue sarcoma subtypes. The FDA agreed with the trial design to enroll separate noncomparative cohorts of 80 patients each with undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS), with the first cohort receiving single-agent envafolimab and the second cohort receiving envafolimab plus Yervoy (ipilimumab), with the primary endpoint being objective response rate by RECIST by blinded independent radiographic review in each cohort. TRACON expects to initiate dosing of ENVASARC in the second half of 2020, provide interim clinical trial data in 2021, final clinical trial data in 2022, and provided the drug is approved by the
US FDA, commercialize envafolimab in 2023.
- In April, TRACON amended its agreement with
Aspire Capital Fund, LLC( Aspire Capital) to lower the minimum price of shares sold to be considered at the market purchases for Nasdaq purposes to $1.89per share. Under the amended agreement, Aspire Capitalis committed to purchase up to an aggregate of $15.0 millionof shares of our common stock at our request from time to time until June 2022, $14.2 millionof which remained available for sale as of March 31, 2020.
- In April, TRACON retained global rights to TRC253 by virtue of Janssen Pharmaceutica N.V.’s decision not to exercise its option to reacquire global rights to TRC253 following a review of the Phase 2 data in prostate cancer patients with acquired resistance to Xtandi or Erleada. TRACON has initiated an out-licensing process to identify a corporate partner to develop and commercialize TRC253 in an earlier line of treatment in
China, where the androgen receptor inhibitors Xtandi and Erleada are not widely accessible.
- In April, TRACON entered into a deferral agreement with
Silicon Valley Bankto defer principal payments for six months, which is expected to extend TRACON’s cash runway further into the first quarter of 2021.
- In March, TRACON’s licensee
Santenannounced the discontinuation of DE-122 development based on top-line data from the Phase 2a AVANTE clinical study that indicated the combination of DE-122 and Lucentis did not improve visual acuity when compared to single-agent Lucentis.
“We are pleased the FDA agreed with our pivotal ENVASARC trial design and endpoints as we believe it can enable a fast to market strategy to provide envafolimab as expeditiously as possible to sarcoma patients in need of a new therapy,” said
Expected Upcoming Milestones
- Receive orphan drug designation for envafolimab in soft tissue sarcoma in the second half of 2020.
- Enroll the first patient in ENVASARC, a pivotal trial in the sarcoma subtypes of
UPSand MFS, during the second half of 2020.
- Report top-line data from the Phase 1 dose escalation study of TJ4309, a CD73 antibody, as a single agent and in combination with Tecentriq (a PD-L1 antibody being supplied by Roche), in the second half of 2020.
First Quarter 2020 Financial Results
- Cash and cash equivalents were
$14.1 millionat March 31, 2020, compared to $16.4 millionat December 31, 2019. We expect our current cash and cash equivalents to fund operations into the first quarter of 2021. We believe our cash runway could extend into the third quarter of 2021 if we were to fully utilize the $14.2 millionthat remains available under the Aspire Capitalagreement.
- Research and development expenses for the first quarter of 2020 were
$2.0 million, compared to $5.2 millionfor the first quarter of 2019. The decrease was primarily attributable to lower manufacturing expenses and clinical trial expenses due to the discontinuation of the Phase 3 TRC105 program and lower manufacturing expenses for TRC253.
- General and administrative expenses for the first quarter of 2020 and 2019 were
- Net loss for the first quarter of 2020 was
$4.0 million, compared to $7.2 millionfor the first quarter of 2019.
Investor Conference Call
The Company will hold a conference call today at
After the live webcast, a replay will remain available on TRACON’s website for 60 days.
Envafolimab is a novel, single-domain antibody against PD-L1 that is administered by subcutaneous injection without the need for an adjuvant. Envafolimab is currently dosing in Phase 1 trials in the
TRC253 is a novel, orally bioavailable small molecule drug that is a potent, high affinity competitive inhibitor of the androgen receptor (AR) and AR mutations, including the F877L mutation. The AR F877L mutation results in an alteration in the AR ligand binding domain that confers resistance to therapies for prostate cancer. Therapies targeting the AR have demonstrated clinical efficacy by extending time to disease progression, and in some cases, the survival of patients with metastatic castration-resistant prostate cancer. However, resistance to these agents is often observed and several molecular mechanisms of resistance have been identified, including gene amplification, overexpression, alternative splicing, and point mutation of the AR. TRC253 recently completed a Phase 1/2 clinical trial in prostate cancer conducted by TRACON. TRACON believes TRC253 can be developed and commercialized successfully in
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 a 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 product development platform. The Company’s clinical-stage pipeline includes: Envafolimab, a subcutaneous PD-L1 single-domain antibody being developed for the treatment of sarcoma with the goal of starting a registrational trial in the
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 plans to further develop product candidates, expectations regarding the timing and scope of clinical trials and availability of clinical data, expected development milestones and timing thereof, estimated cash runway, potential access to future capital, potential utility of product candidates, potential events, payments and actions 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; 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; whether and when any bispecific antibodies are developed under TRACON’s collaboration with
|Unaudited Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)
|Three Months Ended
|Research and development|
|General and administrative||1,886||1,949|
|Total operating expenses||3,884||7,163|
|Loss from operations||(3,884||)||(7,163||)
|Total other income (expense)||(137||)||(50||)|
Net loss per share, basic and diluted
|Weighted‑average common shares outstanding, basic and diluted||5,171,351||2,989,251|
|Condensed Consolidated Balance Sheets|
|Cash and cash equivalents|
|Prepaid and other assets||835||848|
|Total current assets||14,969||17,260|
|Property and equipment, net||19||23|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses|
|Accrued compensation and related expenses||594||1,355|
|Long‑term debt, current portion||1,267||2,604|
|Total current liabilities||8,772||11,834|
|Other long-term liabilities||754||850|
|Long‑term debt, less current portion||3,438||2,739|
|Commitments and contingencies|
|Additional paid‑in capital||169,134||165,028|
|Total stockholders’ equity||2,784||2,698|
|Total liabilities and stockholders’ equity|
|Company Contact:||Investor Contact:|
|Chief Business Officer|
Source: TRACON Pharmaceuticals, Inc.