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Phase 2 clinical trials of TRC105 suggest activity in angiosarcoma and hepatocellular carcinoma
IND filed for the initiation of clinical trials in wet AMD
Cash balance of $61.2 million at June 30, 2015
SAN DIEGO, Aug. 5, 2015 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration and fibrotic diseases, today announced its financial results for the second quarter ended June 30, 2015.
Second Quarter 2015 and Recent Corporate Highlights
"We made substantial progress on both the clinical and regulatory fronts during the second quarter, our first full quarter as a public company. We presented positive data on multiple pipeline products, continued to advance our lead program, TRC105, across multiple solid tumor indications, and saw a significant step in the expansion of our clinical pipeline beyond oncology with the IND filing by our partner, Santen, in wet AMD," said Charles P. Theuer, M.D., Ph.D., President and CEO of TRACON. "We are particularly excited by the ongoing complete responses seen in angiosarcoma, a tumor type known to express high levels of endoglin, and expect to initiate a Phase 3 trial in this indication in 2016."
Upcoming Development Milestones
Second Quarter 2015 Financial Results
Investor Conference Call
The Company will hold a conference call today at 4:30 p.m. EDT / 1:30 p.m. PDT to provide an update on corporate activities and to discuss the financial results of its second quarter 2015. The dial-in numbers are (855) 779-9066 for domestic callers and (631) 485-4859 for international callers. Please use passcode 93406510. 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.
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 multiple Phase 2 clinical trials sponsored by both TRACON and the National Cancer Institute for the treatment of multiple solid tumor types in combination with VEGF inhibitors. TRC105 is also being developed in combination with VEGF inhibitor treatments in wet AMD. For more information about the clinical trials, please visit TRACON's website at http://www.traconpharma.com/clinical_trials.php.
About Wet AMD
Wet AMD is the leading cause of blindness worldwide in the elderly and is caused by excessive growth and leakage of blood vessels at the back of the eye that leads to a chronic and often rapid loss of vision. Existing therapies for the disease are limited, including treatment targeting the VEGF pathway.
TRC102 is a novel, clinical-stage 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 clinical trials sponsored by both the National Cancer Institute and Case Cancer Center. For more information about the clinical trials, please visit TRACON's website at http://www.traconpharma.com/clinical_trials.php.
TRACON develops targeted therapies for cancer, wet AMD and fibrotic diseases. TRACON's current pipeline includes two clinical stage product candidates: TRC105, an anti-endoglin antibody that is being developed for the treatment of renal cell carcinoma, soft tissue sarcoma, hepatocellular carcinoma, glioblastoma and choriocarcinoma, and TRC102, a small molecule that is being developed for the treatment of lung cancer and glioblastoma. To learn more about TRACON and its product candidates, visit TRACON's website at www.traconpharma.com.
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 its product candidates, expectations regarding the initiation and timing of future clinical trials by TRACON or third parties, and expected regulatory submissions and determinations. Risks that could cause actual results to differ from those expressed in these forward-looking statements include: risks associated with clinical development; whether TRACON, the NCI or others will be able to complete or initiate clinical trials on TRACON's expected timelines, if at all; 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 Santen advances TRC105 (DE-122) in ophthalmological indications or whether the NCI sponsors additional trials of TRACON's product candidates; potential changes in regulatory requirements in the United States and foreign countries; TRACON's reliance on third parties for the development of its product candidates, including the conduct of its clinical trials and manufacture of its product candidates; whether TRACON will be able to obtain additional financing; and other risks described in TRACON's filings with the Securities and Exchange Commission under the heading "Risk Factors". All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. TRACON undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
|TRACON Pharmaceuticals, Inc.|
|Unaudited Condensed Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Collaboration revenue||$ 4,197||$ 1,069||$ 5,329||$ 1,425|
|Research and development||5,405||1,560||9,236||2,821|
|General and administrative||1,476||400||2,489||827|
|Total operating expenses||6,881||1,960||11,725||3,648|
|Loss from operations||(2,684)||(891)||(6,396)||(2,223)|
|Total other income (expense)||(237)||(89)||(520)||(118)|
|Accretion to redemption value of redeemable convertible preferred stock||--||(66)||(31)||(132)|
|Net loss attributable to common stockholders||$ (2,921)||$ (1,046)||$ (6,947)||$ (2,473)|
|Net loss per share attributable to common stockholders, basic and diluted||$ (0.24)||$ (0.65)||$ (0.69)||$ (1.53)|
|Weighted-average common shares outstanding, basic and diluted||12,096,599||1,614,851||10,071,838||1,614,851|
|TRACON Pharmaceuticals, Inc.|
|Condensed Balance Sheets|
|June 30,||December 31,|
|Cash and cash equivalents||$ 61,164||$ 35,000|
|Prepaid and other assets||4,315||728|
|Total current assets||65,479||35,728|
|Property and equipment, net||143||97|
|Total assets||$ 65,662||$ 38,171|
|Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit)|
|Accounts payable and accrued expenses||$ 6,097||$ 3,974|
|Current portion of deferred revenue||4,789||4,357|
|Preferred stock warrant liabilities||--||246|
|Long-term debt, current portion||--||4,676|
|Total current liabilities||10,886||13,253|
|Other long-term liabilities||773||408|
|Long-term debt, less current portion||6,812||4,258|
|Commitments and contingencies|
|Redeemable convertible preferred stock||--||49,880|
|Stockholders' equity (deficit):|
|Additional paid-in capital||87,875||2,004|
|Total stockholders' equity (deficit)||46,791||(32,174)|
|Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit)||$ 65,662||$ 38,171|
CONTACT: Company Contact: Casey Logan Chief Business Officer (858) 550-0780 ext. 236 firstname.lastname@example.org Investor Contact: Andrew McDonald LifeSci Advisors LLC 646-597-6987 Andrew@lifesciadvisors.comNEXT ARTICLE
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