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SAN DIEGO, Nov. 07, 2018 (GLOBE NEWSWIRE) -- 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, today announced financial results for the third quarter ended September 30, 2018.
Third Quarter 2018 and Recent Corporate Highlights
“We anticipate significant potential catalysts over the next two quarters, including two randomized data points: top-line Phase 2 data from TRAXAR in renal cell carcinoma and interim Phase 3 results from TAPPAS in angiosarcoma” said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. “Of note, we continue to be encouraged by the rapid rate of accrual into the Phase 3 TAPPAS angiosarcoma trial.”
Expected Upcoming Milestones
Third Quarter 2018 Financial Results
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 third 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.
TRC102 (methoxyamine) 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 multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute or Case Comprehensive Cancer Center. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.
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. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php
TRACON develops targeted therapies for cancer and ophthalmic diseases. The Company’s clinical-stage pipeline includes: TRC105, an endoglin antibody that is being developed for the treatment of multiple cancers; DE-122, the ophthalmic formulation of TRC105 that is being developed in wet AMD through a collaboration with Santen Pharmaceutical Company Ltd.; TRC102, a small molecule being developed for the treatment of lung cancer and glioblastoma; and TRC253, a small molecule being developed for the treatment of prostate cancer. TRACON is actively seeking additional corporate partnerships whereby it shares in the cost and risk of clinical development and commercialization of new product candidates. In these partnerships TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in the United States. 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 timing and scope of clinical trials and availability of clinical data, expected development milestones, estimated cash runway, and potential utility of TRACON’s product candidates. 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; 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; 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; the possibility of unexpected expenses or other uses of TRACON’s cash resources; 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 Consolidated Statements of Operations
(in thousands, except share and per share data)
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research and development||6,976||4,257||24,529||14,732|
|General and administrative||2,107||1,847||5,480||5,879|
|Total operating expenses||9,083||6,104||30,009||20,611|
|(Loss) income from operations||(9,083)||1,394||(27,009)||(11,856)|
|Total other expense||(2)||(224)||(194)||(687)|
|Net (loss) income||($9,085)||$1,170||($27,203)||($12,543)|
|Net (loss) income per share, basic and diluted||($0.30)||$0.07||($1.05)||($0.76)|
|Weighted-average common shares outstanding, basic||29,837,486||16,828,801||25,962,237||16,550,730|
|Weighted-average common shares outstanding, diluted||29,837,486||17,137,311||25,962,237||16,550,730|
TRACON Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
|September 30,||December 31,|
|Cash and cash equivalents||$28,193||$29,467|
|Prepaid and other assets||1,268||1,591|
|Total current assets||48,439||36,057|
|Property and equipment, net||52||73|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses||$12,062||$6,800|
|Accrued compensation and related expenses||1,156||1,494|
|Current portion of deferred revenue||-||667|
|Long-term debt, current portion||370||2,837|
|Total current liabilities||13,588||11,798|
|Other long-term liabilities||371||409|
|Long-term debt, less current portion||5,973||4,603|
|Commitments and contingencies|
|Additional paid-in capital||160,433||121,670|
|Total stockholders’ equity||28,559||16,987|
|Total liabilities and stockholders’ equity||$48,491||$36,130|
|Company Contact:||Investor Contact:|
|Mark Wiggins||Andrew McDonald|
|Chief Business Officer||LifeSci Advisors LLC|
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