Shares of Threshold Pharmaceuticals, Inc. (NASDAQ:THLD) ended Tuesday session in red amid volatile trading. The shares closed down -0.10 points or -7.75% at $1.19 with 2.52 million shares getting traded. Post opening the session at $1.25, the shares hit an intraday low of $1.18 and an intraday high of $1.28 and the price vacillated in this range throughout the day. The company has a market cap of $89.98 million and the numbers of outstanding shares have been calculated to be 71.51 million shares.
Threshold Pharmaceuticals, Inc. (THLD) on Aug. 01, 2016 reported financial results for the second quarter ended June 30, 2016 and provided an update on the Company’s corporate and clinical development activities.
“Encouraged by the MAESTRO data presented recently at ASCO that demonstrated meaningful improvement in overall survival in the subgroup of patients from Japan and South Korea, we are pursuing a registration strategy for Japan,” said Barry Selick, Ph.D., Chief Executive Officer of Threshold. “We have also been encouraged by the translational data evaluating the role of hypoxia in mediating treatment resistance to cancer immunotherapy conducted by collaborators at the MD Anderson Cancer Center and to initiating a clinical trial evaluating evofosfamide in combination with checkpoint blockade.”
Evofosfamide – The Company’s lead product candidate is an investigational hypoxia-activated prodrug that is designed to be activated under tumor hypoxic conditions, a hallmark of many cancers.
- Additional data analyses from the MAESTRO Phase 3 trial, which were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting recently, reported on the subgroup of 123 Asian patients enrolled at Japanese and South Korean sites in which the risk of death was reduced by 48 percent for patients on the treatment arm compared to patients on the control arm with an associated stratified hazard ratio of 0.52 (95% CI: 0.32 – 0.85);
- The Company is evaluating the feasibility of submitting a New Drug Application (NDA) for registration with the Pharmaceuticals and Medical Devices Agency, or PMDA, in Japan based on the results seen in the Japanese sub-population;
- Clinical development collaborations investigating evofosfamide in patients with pancreatic neuroendocrine tumors (pNET), recurrent glioblastoma (GBM) and hepatocellular carcinoma (HCC) remain ongoing; and
- A recent presentation by one of the Company’s collaborators from the MD Anderson Cancer Center highlighted the promise of evofosfamide in combination with “checkpoint antibodies” to improve the efficacy of this class of potent anti-cancer therapies. A clinical trial evaluating evofosfamide plus ipilimumab to treat a variety of solid tumors is planned.
Tarloxotinib – Beyond the evofosfamide program, the Company is pursuing the Phase 2 proof of concept studies with tarloxotinib, a hypoxia-activated epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), which is designed to selectively release an irreversible EGFR-TKI in hypoxic tumors.
- Investigations continue in two proof-of-concept, Phase 2 clinical trials in patients with advanced non-small cell lung cancer (NSCLC) and patients with metastatic squamous cell carcinoma of the head and neck and skin; the designs of both trials necessitate a minimum response rate for study continuation. When the specified target numbers of patients have been assessed, the Company plans to report the preliminary results; this is estimated to occur in the third quarter of 2016.
Second Quarter 2016 Financial Results
- Cash, cash equivalents and marketable securities totaled $33.6 million at June 30, 2016 compared to $38.0 million at March 31, 2016; the net decrease of $4.4 million was a result of operating cash requirements for the quarter ended June 30, 2016. With the previously announced decision to cease joint development of evofosfamide under the Company’s former collaboration with Merck KGaA and the workforce reduction, the Company continues to expect its operating cash requirements to be lower for the second half of fiscal year 2016 compared to the first half of 2016.
- No revenue was recognized in the second quarter ended June 30, 2016 compared to $3.7 million for the same period of 2015. Revenue for the quarter ended June 30, 2015 related to the amortization of the aggregate of $110 million in upfront and milestone payments received from the Company’s former collaboration with Merck KGaA, Darmstadt, Germany. The revenue from the upfront payment and milestone payments received under the agreement were previously being amortized over the relevant performance period, rather than being immediately recognized when the upfront payment and milestones were earned or received. As a result of Merck KGaA, Darmstadt, Germany’s and the Company’s decision to cease further joint development of evofosfamide in December 2015, the Company immediately recognized all of the remaining deferred revenue into revenue during the quarter ending December 31, 2015. Also as a result of the termination of the agreement, the Company is no longer eligible to receive any further milestone payments from Merck KGaA, Darmstadt, Germany.
- Research and development expenses were $4.0 million for the second quarter ended June 30, 2016, compared to $10.1 million for the same period in 2015. The decrease in research and development expenses, net of reimbursement for Merck KGaA, Darmstadt, Germany’s 70 percent share of total eligible collaboration expenses for evofosfamide, was due primarily to a $3.6 million decrease in employee related expenses, including a $0.9 million decrease in non-cash stock-based compensation expense and a $2.5 million decrease in clinical development expenses and consulting expenses. The Company expects research and development expenses to continue to decline in 2016 as result of the decision to cease further joint development of evofosfamide under the Company’s former collaboration with Merck KGaA and the workforce reduction.
Shares of Intercept Pharmaceuticals Inc (NASDAQ:ICPT) ended Tuesday session in red amid volatile trading. The shares closed down -4.73 points or -3.12% at $146.89 with 336,106.00 shares getting traded. Post opening the session at $150.63, the shares hit an intraday low of $146.36 and an intraday high of $151.29 and the price vacillated in this range throughout the day. The company has a market cap of $3.79 billion and the numbers of outstanding shares have been calculated to be 24.73 million shares.
Intercept Pharmaceuticals Inc (ICPT) on Aug. 17, 2016 announced that the New England Journal of Medicine published the key results of the Phase 3 POISE trial of Ocaliva (obeticholic acid) for the treatment of patients with primary biliary cholangitis, formerly known as primary biliary cirrhosis (PBC). On a background of standard of care or given as monotherapy, Ocaliva met the primary endpoint of the POISE trial and improved multiple biochemical disease markers as compared to placebo with high statistical significance.
The POISE trial evaluated the safety and efficacy of once-daily treatment with Ocaliva in PBC patients with an inadequate therapeutic response to, or who are unable to tolerate, ursodeoxycholic acid (UDCA). The trial`s primary endpoint was a reduction in alkaline phosphatase (ALP) to below a threshold of 1.67 times the upper limit of the normal range, with a reduction of at least 15% from baseline, and a total bilirubin level at or below the upper limit of the normal range after 12 months of Ocaliva therapy. These liver biomarkers have been shown to be reasonably likely to predict progression to liver failure and resulting liver transplant or premature death in patients with PBC. Ocaliva 5-10 mg (46%) and Ocaliva 10 mg (47%) were both statistically superior to placebo (10%) in achieving the primary endpoint (p<0.001). Most Ocaliva-treated patients had liver biochemical improvements even if they did not achieve the composite primary endpoint, with a significantly higher percent of patients achieving greater than or equal to 15% ALP reduction with Ocaliva 5-10 mg and Ocaliva 10 mg (both groups 77%) compared to placebo (29%) (p<0.001). The majority of patients (93%) continued receiving UDCA therapy during the trial.
“The POISE data support Ocaliva as an important new treatment option for the substantial group of PBC patients who have an inadequate response to, or cannot tolerate, UDCA and therefore remain at risk of adverse outcomes,” said Frederik Nevens, M.D., Ph.D., University Hospitals Leuven & KU Leuven, Belgium, and the lead author of the paper. “For nearly 20 years, we only had one option to help our PBC patients. The introduction of Ocaliva provides physicians and patients with an opportunity to rethink treatment goals and take action when ALP and/or bilirubin remain elevated despite UDCA therapy.”