TRACON Pharmaceuticals, Inc. (NASDAQ:TCON) Files An 8-K Other Events

Item 8.01Other Events.

On January 3, 2017, TRACON Pharmaceuticals, Inc. (TRACON) issued
a press release announcing that it had reached an agreement with
the U.S. Food and Drug Administration (FDA) under a Special
Protocol Assessment (SPA) for the protocol design, clinical
endpoints and statistical analysis approach for the Company’s
Phase 3 study evaluating TRC105 for the treatment of patients
with advanced angiosarcoma.

TRACON intends to conduct the Phase 3 TAPPAS trial (a randomized
Phase 3 trial of TRC105 And Pazopanib versus Pazopanib alone in
patients with advanced AngioSarcoma) at sites in both the United
States and Europe. This one-to-one randomized trial of TRC105 in
combination with Votrient (pazopanib) versus Votrient alone will
initially enroll 124 patients. The trial features an adaptive
design that, based on an interim analysis, can allow for sample
size re-estimation up to a maximum of 200 patients, as well as
possible enrichment of more responsive patients with cutaneous
angiosarcoma. The primary endpoint of the trial is
progression-free survival (PFS), with overall survival (OS) as a
secondary endpoint.

The press release issued on January 3, 2017 is attached hereto as
Exhibit 99.1.

Forward-Looking Statements

This report and the exhibit hereto contain forward-looking
statements, including statements regarding the potential benefits
that may be derived from the SPA, TRACON’s plans to further
develop its product candidates and expectations regarding the
initiation, design and timing of future clinical trials by TRACON
or third parties. Risks that could cause actual results to differ
from those expressed in these forwardlooking statements include:
risks associated with clinical development; whether TRACON or
others will be able to complete or initiate clinical trials on
TRACONs expected timelines, if at all; whether TRACON will
realize expected benefits from the SPA; the fact that the SPA
does not guarantee regulatory approval, even if the planned Phase
3 trial meets the agreed-upon endpoints; the fact that future
preclinical studies and clinical trials may not be successful or
otherwise consistent with results from prior studies; potential
changes in regulatory requirements in the United States and
foreign countries; TRACONs reliance on third parties for the
development of its product candidates, including the conduct of
its clinical trials and manufacture of its product candidates;
and whether TRACON will be able to obtain additional
financing.For a further description of these and other risks
facing TRACON, please see the risk factors described in TRACONs
filings with the United States Securities and Exchange
Commission, including those factors discussed under the caption
“Risk Factors” in those filings. Forward-looking statements
speak only as of the date of this report and TRACON undertakes no
obligation to update or revise these statements, except as may be
required by law.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

About TRACON Pharmaceuticals, Inc. (NASDAQ:TCON)

TRACON Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on the development and commercialization of therapeutics for cancer, wet age-related macular degeneration (wet AMD) and fibrotic diseases. The Company’s research focuses on antibodies that bind to the endoglin receptor, which is essential to angiogenesis (the process of new blood vessel formation) and a contributor to fibrosis (tissue scarring). The Company’s lead product candidate, TRC105, is an endoglin antibody that is being developed for the treatment of multiple solid tumor types in combination with inhibitors of the vascular endothelial growth factor (VEGF) pathway. TRC205 is being developed for the treatment of fibrotic disease. The Company is also developing TRC102, a small molecule that is in clinical development for the treatment of lung cancer and glioblastoma.

TRACON Pharmaceuticals, Inc. (NASDAQ:TCON) Recent Trading Information

TRACON Pharmaceuticals, Inc. (NASDAQ:TCON) closed its last trading session up +0.05 at 5.35 with 540,822 shares trading hands.