On August 8, 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 second quarter ended June 30, 2018 (Press release, Tracon Pharmaceuticals, AUG 8, 2018, View Source [SID1234528546]).

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Second Quarter 2018 and Recent Corporate Highlights

In August, we submitted an amendment to the FDA for the Phase 3 TAPPAS trial of TRC105 for the treatment of angiosarcoma that is accruing at 26 sites in the United States and multiple sites in the United Kingdom and France. The amendment proposes an increase in the trial sample size to account for the fewer than expected number of events that define the endpoint of progression free survival, reflecting a higher than expected rate of withdrawal for progressive disease unconfirmed by central review. The amendment increases the number of patients analyzed at the interim analysis from 70 to 120. Although the trial is enrolling at a higher rate than expected, with more than 80 patients enrolled, the amendment is expected to delay the interim analysis until Q1 2019.

In July, we completed enrollment in the Phase 1 portion of a Phase 1/2 trial of TRC253 and determined the recommended Phase 2 dose for patients with metastatic prostate cancer. Dosing in the Phase 2 portion of the trial commenced in August. 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.

In June, preclinical data from two murine models assessing the activity of TRC105 in combination with a PD-1 antibody were presented at the 2018 International Cancer Microenvironment Society meeting. The combination of treatment with TRC105 and the PD-1 antibody significantly reduced tumor volume compared to treatment with either individual therapy in both tumor models. Survival was significantly improved with combination treatment versus the individual therapies, with long-term survival demonstrated in 30% to 60% of animals. Combination treatment also increased tumor specific T cells, indicating stimulation of an immune response. TRC105 is being developed with the PD-1 checkpoint inhibitor Opdivo in patients with lung cancer in a Phase 1 trial.

In April, 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.
"We anticipate significant news flow over the next few quarters with three major data events from TRC105 trials, including two randomized data points: top-line Phase 2 data in renal cell carcinoma and interim Phase 3 results in angiosarcoma" said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We continue to be encouraged by the rapid rate of accrual into the Phase 3 TAPPAS angiosarcoma trial."

Expected Upcoming Milestones

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 prior to the end of 2018.

Announcement of data from the Phase 1b trial of TRC105 in combination with Opdivo in patients with non-small cell lung cancer is expected prior to the end of 2018.

Announcement of the results of the interim analysis from the Phase 3 pivotal TAPPAS trial of TRC105 in angiosarcoma is expected in Q1 2019.
Second Quarter 2018 Financial Results

Cash, cash equivalents and short-term investments were $53.4 million at June 30, 2018, compared to $34.5 million at December 31, 2017. We expect our current cash, cash equivalents and short-term investments to fund operations into Q4 2019.

Research and development expenses for the second quarter of 2018 were $8.1 million compared to $4.9 million for the second quarter of 2017. The increase was primarily attributable to increased TRC105 drug manufacturing activities in the second quarter of 2018 as compared to the 2017 period.

General and administrative expenses for the second quarter of 2018 were $1.6 million compared to $2.1 million for the second quarter of 2017.

Net loss for the second quarter of 2018 was $9.8 million compared to $6.6 million for the second 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 second 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, as well as in a Phase 1 trial with Opdivo. 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