Earnings Analysis to Watch: Cara Therapeutics Inc. (CARA), Earth Science Tech Inc (ETST), Zynerba Pharmaceuticals Inc. (ZYNE)

Earnings Analysis to Watch: Cara Therapeutics Inc. (CARA), Earth Science Tech Inc (ETST), Zynerba Pharmaceuticals Inc. (ZYNE)

Earnings Analysis to Watch: Cara Therapeutics Inc. (CARA), Earth Science Tech Inc (ETST), Zynerba Pharmaceuticals Inc. (ZYNE)

Cara Therapeutics Inc. (NASDAQ: CARA) showing jumped of 5.89% and closed at $16.17, after gaining total volume of 1.37 million shares. Its earnings per share (EPS) is -$2.10 and its beta value stands at 3.20 points and has total market capitalization of $430.77 million and a total of 27.30 million outstanding shares.

Cara Therapeutics Inc. (CARA) on March 10, 2017 announced financial results for the fourth quarter and full year ended December 31, 2016.

“In 2016, we advanced our three late-stage trials in indications of high unmet need where existing therapies are ineffective or are limited by significant side effects and the high potential for abuse,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “We look forward to a transformative 2017, as we anticipate sharing efficacy data for CR845 in uremic pruritus, acute postoperative pain and chronic pain.”

Fourth Quarter and Recent Business Highlights

  • In September 2016, initiated Phase 2b trial evaluating three doses of oral CR845 in chronic pain patients with osteoarthritis (OA).
  • In October 2016, delivered presentation and hosted industry symposium at the 10th Annual Pain & Migraine Therapeutics Summit and ANESTHESIOLOGY® 2016, respectively, at which the Company discussed CR845 as a novel approach to acute and chronic pain management due to its unlikeliness to lead to physical dependence.
  • In November 2016, announced the completion of enrollment in Part A of an adaptive Phase 2 / 3 trial of I.V. CR845, which was initiated in June 2016 in dialysis patients suffering from moderate-to-severe uremic pruritus (UP), an intractable systemic itch condition in patients with chronic kidney disease (CKD), for which there are no approved therapies in the United States.
  • In November 2016, presented two posters at Kidney Week, the American Society of Nephrology’s Annual Meeting, which included positive data from the Company’s Phase 2 study of I.V. CR845 in UP.

Expected 2017 Milestones

  • Top-line data expected in the first quarter of 2017 from Part A of the adaptive Phase 2/3 trial of I.V. CR845 in 160 dialysis patients suffering from moderate-to-severe UP.
  • Trial completion expected in the first quarter of 2017, with data readout expected in the second quarter of 2017, from a pharmacokinetic safety trial of multiple doses of Oral CR845 in hemodialysis patients to define bioequivalent tablet strengths to inform the ability to develop an oral tablet formulation for moderate-to-severe UP.
  • Top-line data expected in the second quarter of 2017 from the Phase 2b trial of Oral CR845, for the treatment of pain associated with OA.
  • Interim conditional power analysis expected in the second quarter of 2017 from CLIN-3001, our 450 patient adaptive Phase 3 trial of I.V. CR845 in postoperative pain.
  • Data expected in the second quarter of 2017 from a Phase 1 trial to quantitatively assess any effects of I.V. CR845 on respiratory drive after bolus infusion in healthy volunteers.

Earth Science Tech Inc (OTCMKTS:ETST) reported the up of 5.24% and closed at $2.04, with the total traded volume of 23,859.00 million shares. During last trade its minimum price was $111,291.00 and it gained its highest price of $2.09 and has a total of 40.91 million outstanding shares.

On February 23, 2017 Earth Science Tech Inc (ETST), an innovative biotech company focused on hemp cannabinoid research and development, has begun composition work on its two (2) new Cannabis Cannabinoid-Based pharmaceutical drugs and has initiated patent studies on its three (3) new nutraceutical products. This is the first project Earth Science Tech and its wholly owned subsidiary, Cannabis Therapeutics, are working with Smart Medicines GMP on as a result of the Company’s recently finalized joint venture.

Earth Science Tech and Cannabis Therapeutics two new Cannabis Cannabinoid-Based pharmaceutical drug formulations (compositions) are expected to be completed by summer 2017, with non-prescription nutraceuticals being available for sale before the end of the year and the pharmaceutical-grade products being launched in the first or second quarter of 2018.

Earth Science Tech and Cannabis Therapeutics initial patent-pending Cannabinoid-Based nutraceutical product/products being developed seek to offer a broad spectrum of health protection, including immune system strengthening properties and strong antioxidant properties among a variety of other heath & overall wellness benefits. Another nutraceutical Cannabinoid-Based product in the pipeline seeks to improve and protect brain and liver function, which can improve the quality of life for patients, especially those experiencing harsh side effects from traditional medicines. The final nutraceutical to be developed is a prophylactic that aims to prevent some of the more common causes of cancer to help reduce occurrence rates.

Zynerba Pharmaceuticals Inc. (NASDAQ:ZYNE) increased 3.43% closed at $19.62 and traded with total volume of 229,628.00 shares, while the average trading remained 445,312.00 shares. During last trade its minimum price was $18.90 and it gained the highest price of $19.84. Its market capitalization was $240.88 million.

Zynerba Pharmaceuticals Inc. (ZYNE) on March 13, 2017 announced that it has completed enrollment in the Phase 2 STAR 1 (Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy) clinical trial evaluating ZYN002 cannabidiol (CBD) gel in adult epilepsy patients with refractory focal seizures. The Company also announced that enrollment has completed in the Phase 2 STOP (Synthetic Transdermal Cannabidiol for the Treatment of Knee Pain due to Osteoarthritis) clinical trial evaluating ZYN002 CBD gel for the treatment of osteoarthritis.

In the double-blind, multi-center STAR 1 trial, 224 patients with refractory epilepsy were screened and the Company expects to exceed the target of randomizing 180 patients once the remaining patients complete the 8-week baseline period. The screen failure rate experienced for this trial has been between 10% – 15%.  The primary endpoint for the STAR 1 trial will assess the median percentage change in seizure frequency over the 12-week treatment period.

In the double-blind, multi-center STOP trial, 418 patients with osteoarthritis knee pain were screened and the Company has already exceeded the target of randomizing 300 patients.  Additional patients still in the baseline period are expected to be randomized as well and the screen failure rate experienced for this trial has been between 20% – 25%. The primary endpoint for the STOP trial will assess the change from baseline in the weekly mean of the 24-hour average of worst pain score.

“Reaching our target patient enrollment in the STAR 1 and STOP Phase 2 clinical studies represents key clinical milestones for Zynerba and we remain  on-track to report top-line data for each trial in July/August of this year,” said Armando Anido, chairman and chief executive officer. “The rapid enrollment and significant interest in our trials is highly encouraging. We will continue working diligently to move these potential treatments through clinical and regulatory development as efficiently as possible.”

Leave a reply

0 Comments

There are no comments on this post.