On May 9, 2018 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and wet age‐related macular degeneration, reported financial results for the first quarter ended March 31, 2018 (Press release, Tracon Pharmaceuticals, MAY 9, 2018, View Source [SID1234526400]).
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First Quarter 2018 and Recent Corporate Highlights
In April 2018, TRACON closed a private placement of its common stock and warrants providing aggregate gross proceeds of approximately $38.7 million. In conjunction with the financing, the Company appointed Ted Wang, Ph.D., Chief Investment Officer of Puissance Capital Management, to its Board of Directors.
Enrollment continues in the Phase 3 TAPPAS trial of TRC105 for the treatment of angiosarcoma that is accruing at 25 sites in the United States and multiple sites in the United Kingdom and France. At the initial meeting in May 2018, the Independent Data Monitoring Committee recommended that the trial continue as planned. We expect to conduct the interim analysis to determine the final sample size and eligible population for the trial in the second half of 2018.
Enrollment continues in the Phase 1/2 trial of TRC253, TRACON’s product candidate for the treatment of prostate cancer that was in-licensed from Janssen. The Phase 1/2 trial is designed to assess safety, determine the recommended Phase 2 dose and assess response by prostate-specific antigen (PSA) levels. If Janssen opts to reacquire TRC253 prior to or following completion of the Phase 1/2 trial, TRACON is entitled to receive a $45.0 million opt-in payment, up to $137.5 million in potential milestone payments and a low-single digit royalty.
"Our clinical programs continue to advance as planned, and we expect multiple potentially value-creating data readouts over the remainder of 2018, all delivered through our cost-efficient product development platform," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Most importantly, our global pivotal Phase 3 TAPPAS trial of TRC105 in angiosarcoma continues to enroll well, with the key interim analysis expected in the second half of the year."
Expected Upcoming 2018 Milestones
Presentation of data from preclinical studies of TRC105 in combination with PD-1 checkpoint inhibition at International Microenvironment Cancer Society meeting in June 2018 in Lisbon.
Completion of the dose escalation portion of the Phase 1/2 trial of TRC253 in patients with prostate cancer in mid-2018.
Announcement of top-line data from the randomized Phase 2 TRAXAR trial of TRC105 in combination with Inlyta for patients with advanced or metastatic renal cell carcinoma is expected in the second half of 2018.
Announcement of the results of the interim analysis from the Phase 3 pivotal TAPPAS trial of TRC105 in angiosarcoma is expected in the second half of 2018.
Presentation of data from the Phase 1b trial of TRC105 in combination with Opdivo in patients with non-small cell lung cancer is expected in the second half of 2018.
First Quarter 2018 Financial Results
Cash, cash equivalents and short-term investments were $62.5 million at March 31, 2018, compared to $34.5 million at December 31, 2017.
Collaboration revenue was $3.0 million for the first quarter of 2018 compared to $0.6 million for the first quarter of 2017. The increase was due to the $3.0 million non-refundable upfront payment received in connection with the Ambrx agreement recorded as revenue in the first quarter of 2018.
Research and development expenses for the first quarter of 2018 were $9.4 million compared to $5.6 million for the first quarter of 2017. The increase was primarily attributable to increased TRC105 drug manufacturing activities in the first quarter of 2018 as compared to the 2017 period.
General and administrative expenses for the first quarter of 2018 were $1.8 million compared to $2.0 million for the first quarter of 2017.
Net loss for the first quarter of 2018 was $8.4 million compared to $7.1 million for the first quarter of 2017.
Investor Conference Call
The Company will hold a conference call today at 4:30 p.m. EST / 1:30 p.m. PST to provide an update on corporate activities and to discuss the financial results of its first quarter of 2018. The dial-in numbers are (855) 779‑9066 for domestic callers and (631) 485-4859 for international callers. Please use passcode 3189378. 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 Carotuximab (TRC105)
TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in a pivotal Phase 3 trial in angiosarcoma and multiple Phase 2 clinical trials, in combination with VEGF inhibitors. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a randomized Phase 2 trial for patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.
About TRC253
TRC253 is a novel, orally bioavailable small molecule that is a potent, high affinity competitive inhibitor of the androgen receptor (AR) and AR mutations, including the F876L (also known as F877L) mutation. The AR F876L mutation results in an alteration in the AR ligand binding domain that confers resistance to therapies for prostate cancer. Activation of the AR is crucial for the growth of prostate cancer at all stages of the disease. 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.