Second Quarter 2017 and Recent Corporate Highlights
- In July, TRACON and its partner,
Santen Pharmaceutical Co. Ltd.(Santen), announced the initiation of a Phase 2a study of DE-122, the ophthalmic formulation of TRC105, for the treatment of patients with wet age-related macular degeneration (AMD). The Phase 2a study is a randomized controlled trial designed to assess the safety and efficacy of repeated intravitreal injections of DE-122 in combination with Lucentis® (ranibizumab) compared to Lucentis monotherapy in patients with wet AMD. The initiation of the Phase 2a study triggered a $7.0 millionmilestone payment obligation to TRACON.
- In June, the Company presented positive clinical data from studies of TRC105 at the annual meeting of the
American Society of Clinical Oncology( ASCO). In separate Phase 1b clinical trials combining TRC105 with Votrient® (pazopanib) in patients with soft tissue sarcoma and TRC105 with Inlyta® (axitinib) in patients with renal cell carcinoma (RCC), overall response to treatment showed a statistically significant association with baseline levels of certain soluble biomarkers. These biomarkers will be further assessed in the ongoing Phase 3 randomized TAPPAS trial that combines TRC105 with Votrient in angiosarcoma and the randomized Phase 2 TRAXAR trial that combines TRC105 with Inlyta in patients with RCC.
- In June, at the
ASCOannual meeting, the National Cancer Institute(NCI) reported data from its trial of TRC102 in combination with Temodar® (temozolomide) in patients with refractory solid tumors. Based on partial responses in patients with ovarian cancer, non-small cell lung cancer and KRAS-positive colorectal cancer, the NCI elected to enroll expansion cohorts in each of these tumor types at the recommended Phase 2 oral dose of TRC102. The authors concluded that the combination of Temodar and TRC102 is active, and markers of DNA damage response (Rad51, ϒ-H2AX and/or pNbs1) were induced in 4 of 5 paired colon biopsies, indicating DNA damage following treatment.
- In May, positive results from the NCI-sponsored Phase 1/2 trial of TRC105 and Nexavar® (sorafenib) in patients with hepatocellular cancer (HCC) were e-published in the journal,
Clinical Cancer Research. Overall response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) across four dose groups. All observed responses occurred in the two highest dose groups, in which 5 of 15 (33%) patients demonstrated a response. Median progression free survival (PFS) was 3.8 months and median overall survival (OS) was 15.5 months. Nexavar was approved for the treatment of patients with advanced HCC based on data showing a median OS of 10.7 months versus 7.9 months with placebo in the multicenter SHARP trial. The ORR for Nexavar treatment by RECIST in the SHARP trial was 2%. TRACON is currently conducting a multicenter Phase 1/2 trial of TRC105 in combination with Nexavar in patients with HCC and expects to report initial data in the first half of 2018.
- In May, the Company announced the initiation of dosing in a Phase 1/2 clinical trial of TRC253 in patients with metastatic castration-resistant prostate cancer. The primary objectives of the Phase 1/2 study are to assess the safety of TRC253, determine its recommended Phase 2 dose and evaluate response by prostate-specific antigen (
PSA) levels. In the Phase 2 portion of the trial, TRACON intends to incorporate circulating tumor DNA testing to allow for biomarker-directed therapy of patients who have progressed following treatment with an androgen receptor (AR) inhibitor.
- In May, the Company announced that preclinical data indicating the potential clinical utility of targeting endoglin in acute myeloid leukemia (AML) and B-cell acute lymphoblastic leukemia (B-cell ALL), was published in the
May 4, 2017, issue of Blood, the official journal of the American Society of Hematology. TRACON has engaged key opinion leaders to discuss potential clinical trial designs for TRC105 in AML.
“We are encouraged by the continued clinical progress across our entire pipeline, including in hepatocellular cancer. The Phase 3 TAPPAS study of TRC105 in angiosarcoma continues to enroll well, and is on track to deliver key interim data in mid-2018. During the quarter, we also initiated dosing in the Phase 1/2 study of TRC253 in patients with prostate cancer and expect to complete the dose escalation portion of the study by the end of this year,” said
Expected Upcoming Milestones for 2017
- Presentation of data from the Phase 1/2 PAVE study of DE-122 in patients with wet AMD by Santen in the second half of 2017.
- 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 RCC in the second half of 2017.
- Completion of the dose escalation portion in the Phase 1/2 clinical trial of TRC253 in patients with prostate cancer in the second half of 2017.
Second Quarter 2017 Financial Results
- Cash, cash equivalents and short-term investments were
$32.0 millionat June 30, 2017, compared to $44.4 millionat December 31, 2016. The reported cash balance does not include the $7.0 millionmilestone payment from Santen, which the Company expects to receive in the third quarter.
- Collaboration revenue for the second quarter of 2017 was
$0.6 millioncompared to $0.8 millionfor the second quarter of 2016.
- Research and development expenses for the second quarter of 2017 were
$4.9 millioncompared to $6.8 millionfor the second quarter of 2016. The decrease was primarily a result of decreased TRC105 drug manufacturing expenses in 2017.
- General and administrative expenses for the second quarter of 2017 were
$2.1 millioncompared to $2.0 millionfor the second quarter of 2016.
- The net loss for the second quarter of 2017 was
$6.6 millioncompared to a net loss of $8.3 millionfor the second quarter of 2016.
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 Carotuximab (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
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
TRC253 is a novel, orally bioavailable small molecule that is a potent, high affinity competitive inhibitor of the 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 mCRPC. 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.
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 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, Santen, 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 Santen or the NCI completes on-going trials or initiates additional trials of TRACON’s product candidates; potential changes in regulatory requirements in
|TRACON Pharmaceuticals, Inc.|
|Unaudited Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended
|Six Months Ended
|Research and development||4,893||6,773||10,475||12,268|
|General and administrative||2,068||2,044||4,032||4,053|
|Total operating expenses||6,961||8,817||14,507||16,321|
|Loss from operations||(6,330||)||(8,010||)||(13,250||)||(14,304||)|
|Total other income (expense)||(236||)||(287||)||(463||)||(519||)|
Net loss per share, basic and diluted
|Weighted‑average common shares outstanding,
basic and diluted
|TRACON Pharmaceuticals, Inc.|
|Condensed Consolidated Balance Sheets|
|Cash and cash equivalents||$||26,001||$||35,710|
|Prepaid and other assets||814||1,235|
|Total current assets||32,812||45,648|
|Property and equipment, net||78||82|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses||$||6,536||$||6,213|
|Accrued compensation and related expenses||1,096||1,588|
|Current portion of deferred revenue||386||1,259|
|Long‑term debt, current portion||1,162||333|
|Final payment due bank||-||850|
|Total current liabilities||9,180||10,243|
|Other long-term liabilities||372||21|
|Long‑term debt, less current portion||6,043||7,130|
|Commitments and contingencies|
|Additional paid‑in capital||116,589||113,918|
|Total stockholders’ equity||17,295||28,336|
|Total liabilities and stockholders’ equity||$||32,890||$||45,730|
Casey LoganChief Business Officer (858) 550‐0780 ext. 236 firstname.lastname@example.org Investor Contact: Andrew McDonald LifeSci Advisors LLC646-597-6987 Andrew@lifesciadvisors.com