“During the fourth quarter of 2016 and beginning of this year, we made significant progress toward several important corporate objectives, and anticipate a number of additional potentially value-creating milestones over the remainder of 2017,” said
Fourth Quarter 2016 and Recent Corporate Highlights
February 2017, the Company initiated dosing in the Phase 3 TAPPAS (a randomized Phase 3 trial of TRC105 And Pazopanib versus Pazopanib alone in patients with advanced AngioSarcoma) trial of TRC105. In January 2017, the Company announced that agreement was reached 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 TAPPAS trial. This one-to-one randomized trial of TRC105 in combination with Votrient® (pazopanib) versus single agent Votrient features an adaptive enrichment design which allows for greater flexibility and efficiency to identify potential signs of clinical benefit.
February 2017, the Company announced that the combination of TRC105 and Avastin did not improve median PFS versus single agent Avastin in recurrent GBM patients, although the combination was associated with a non-significant increase in overall survival. Detailed survival data and the correlative analyses are expected to be presented at an oncology conference later this year.
January 2017, the FDAcleared the IND for TRC253, a small molecule competitive inhibitor of the wild type androgen receptor and androgen receptor mutations that confer resistance to Xtandi® (enzalutamide) and other drugs approved to treat prostate cancer. TRC253 was in-licensed as part of the Company’s strategic licensing collaboration with Janssen Pharmaceutica N.V.in September 2016. TRACON expects to initiate dosing in a Phase 1/2 trial of TRC253 in the first half of 2017.
November 2016, the Company closed an underwritten public offering of a total of 3,018,750 shares of its common stock resulting in total gross proceeds, before deducting underwriting discounts and commissions and other offering expenses, of $17.4 million.
November 2016, updated data from the ongoing Phase 1b/2 study of TRC105 and Votrient in patients with angiosarcoma were presented at the Connective Tissue Oncology Society(CTOS) annual meeting. The presentation indicated the combination of TRC105 and Votrient continued to demonstrate encouraging signs of activity, including ongoing durable complete responses, and was well-tolerated.
November 2016, preclinical data from two separate liver fibrosis models were presented in a poster at the American Association for the Study of Liver Diseases(AASLD) Annual Meeting entitled, “Endoglin Antibody Reduces the NAFLD Activity Score in the STAM Model of NASH and Reduces Liver Fibrosis Following Carbon Tetrachloride Treatment.” The poster also highlighted a marked reduction in cutaneous neurofibromatosis in a sarcoma patient following dosing with TRC105 and Votrient in a Phase 2 clinical trial, suggesting the potential clinical utility of an endoglin antibody for the treatment of patients with fibrosis.
Additional Expected 2017 Milestones
- Initiation of dosing in the Phase 1/2 trial of TRC253 in patients with prostate cancer.
- Presentation of data from expanded cohorts in the Phase 1 trial of TRC102 and Temodar® (temozolomide) by the
National Cancer Institute.
- Completion of the Phase 1/2 PAVE study of DE-122 in patients with wet AMD by TRACON’s partner,
Santen Pharmaceutical Co., Ltd.(Santen).
- Initiation of dosing in Santen’s Phase 2
AVANTEstudy, a randomized controlled Phase 2 trial of DE-122 and Lucentis® (ranibizumab) versus single agent Lucentis in patients with wet AMD.
- Announcement of top-line data from the randomized Phase 2 TRAXAR trial of TRC105 in combination with Inlyta® (axitinib) in patients with advanced or metastatic renal cell carcinoma.
- Completion of dose escalation in the Phase 1/2 clinical trial of TRC253.
Fourth Quarter 2016 Financial Results
- Cash, cash equivalents and short-term investments were
$44.4 millionat December 31, 2016, compared to $35.1 millionand $52.2 millionat September 30, 2016and December 31, 2015, respectively.
- Collaboration revenue for the fourth quarter of 2016 was
$0.6 million, compared to $1.4 millionfor the fourth quarter of 2015.
- Research and development expenses for the fourth quarter of 2016 were
$4.8 million, compared to $10.6 millionfor the fourth quarter of 2015. The decrease in 2016 as compared to 2015 primarily resulted from decreased TRC105 drug manufacturing expenses.
- General and administrative expenses for the fourth quarter of 2016 were
$1.9 million, compared to $1.7 millionfor the fourth quarter of 2015.
- The net loss for the fourth quarter of 2016 was
$6.3 million, compared to a loss of $11.0 millionfor the fourth quarter of 2015.
Investor Conference Call
The Company will hold a conference call today at
After the live webcast, a replay will remain available on TRACON’s website for 60 days.
About TRC105 and other Endoglin Antibodies
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 one Phase 3 and multiple Phase 2 clinical trials sponsored by TRACON or the
TRACON develops targeted therapies for cancer, ophthalmic and fibrotic 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
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, expected development milestones, availability of additional clinical data 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, 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 or when the NCI completes on-going trials or sponsors additional trials of TRACON’s product candidates; potential changes in regulatory requirements in
|TRACON Pharmaceuticals, Inc.|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended
|Twelve Months Ended
|Research and development||4,767||10,559||21,566||25,680|
|General and administrative||1,925||1,672||7,859||5,691|
|Total operating expenses||6,692||12,231||29,425||31,371|
|Loss from operations||(6,075)||(10,836)||(25,976)||(23,467)|
|Total other income (expense)||(239)||(211)||(1,032)||(943)|
|Accretion to redemption value of redeemable convertible preferred stock||-||-||-||(31)|
|Net loss attributable to common stockholders||$(6,314)||$(11,047)||$(27,008)||$(24,441)|
|Net loss per share attributable to common stockholders, basic and diluted||$(0.45)||$(0.91)||$(2.13)||$(2.20)|
|Weighted‑average common shares outstanding, basic and diluted||14,099,380||12,166,905||12,677,910||11,115,651|
|TRACON Pharmaceuticals, Inc.|
|Condensed Consolidated Balance Sheets|
|December 31,||December 31,|
|Cash and cash equivalents||$35,710||$41,373|
|Prepaid and other assets||1,235||1,150|
|Total current assets||45,648||53,306|
|Property and equipment, net||82||173|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses||$6,213||$8,281|
|Accrued compensation and related expenses||1,588||1,163|
|Current portion of deferred revenue||1,259||3,353|
|Long‑term debt, current portion||333||1,378|
|Final payment due bank||850||-|
|Total current liabilities||10,243||14,175|
|Other long-term liabilities||21||905|
|Long‑term debt, less current portion||7,130||7,464|
|Commitments and contingencies|
|Additional paid‑in capital||113,918||89,556|
|Total stockholders’ equity||28,336||30,978|
|Total liabilities and stockholders’ equity||$45,730||$53,522|
Casey LoganChief Business Officer (858) 550‐0780 ext. 236 firstname.lastname@example.org Investor Contact: Andrew McDonald LifeSci Advisors LLC646-597-6987