Biotech Influence on Cannabinoid-based Drug Development Leading to Latest Clinical Trials for Treatments for Chronic Disorders

Thursday, August 10, 2017 Drug News
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PALM BEACH, Florida, August 10, 2017 /PRNewswire/ --

As the biotechnology

science industry continues to become more involved in medical cannabis, specifically in the area of cannabinoid-based drugs and treatments, revenue generating opportunities across the marijuana sector are beginning to become more and more apparent. Key
factors boosting the legal marijuana market include growing revenues as there are over 20 conditions for which medical marijuana is used, some of the key applications include pain management, arthritis, cancer, multiple sclerosis and Alzheimer's and additional chronic disorders. Active biotech companies in the sector include: Therapix Biosciences Ltd. (NASDAQ: TRPX), Zynerba Pharmaceuticals Inc. (NASDAQ: ZYNE), GW Pharmaceuticals plc (NASDAQ: GWPH), INSYS Therapeutics Inc. (NASDAQ: INSY) and 22nd Century Group Inc. (NYSE: XXII)

Therapix Biosciences Ltd. (NASDAQ: TRPX), a specialty clinical stage pharmaceutical Company specializing in the development of cannabinoid-based drugs, today reported financial results for the three and six months ended June 30, 2017. The Company will host a conference call and webcast today to discuss the financial results and to provide an update on current developments with respect to its clinical programs. Financial Summary - Second Quarter 2017 vs. Second Quarter 2016 (the functional currency of the Company is New Israeli Shekel; for presentation purposes. See the full financial tables at YahooFinance .

Brief details from the press release include:

  • Net loss of $1.9 million, or $0.54 per ADS, for the three months ended June 30, 2017, compared to a net loss of $0.5 million, or $0.61 per ADS, for the three months ended June 30, 2016. This period's net loss included $0.44 million of exchange rate differences on balances of cash and cash equivalents, versus none incurred during the corresponding period in 2016.
  • Research and development ('R&D') expenses amounted to approximately $0.46 million for the three months ended June 30, 2017, compared to approximately $0.23 million for the three months ended June 30, 2016. The increase resulted primarily from a marked rise in expenses in connection with the clinical trials, as well as a R&D studies.
  • Cash totaled $11.8 million as of June 30, 2017, compared to $12.1 million at March 31, 2017. The increase in cash primarily resulted from additional net proceeds raised in the Company's Initial Public Offering through the complete exercise of the underwriter's overallotment option, as well as expenses incurred in our ongoing clinical trials, other R&D expenses, investor relations and business development activities and operational activities. The Company currently believes that its cash balance will be sufficient to maintain its current operations into the third quarter of 2018

Read this entire release and more news for TRPX at:

Business update and developments in Therapix Biosciences clinical R&D programs:

  • In the Company's ongoing study Phase IIa clinical trial in Tourette's Syndrome at Yale University (n=18), 12 patients have been enrolled to date; patient #13 is scheduled to be screened this week. The last patient is currently projected to be enrolled by the end of September or early October, 2017, which is consistent with our previously disclosed estimate. To date, ten patients have completed the entire three-month treatment regimen.
  • In the Yale study, patients that have completed the initial 3-month treatment period have been given the option to extend their treatment for an additional 3 months based on a positive assessment of efficaciousness after the first 3 months. Of the 10 patients that have already completed the initial 3-month treatment period, 8 patients have opted to extend their treatment.
  • In the anticipated proof-of-concept study in MCI, the Company will be evaluating cognition in TBI patients who are generally symptomatic with significant cognitive dysfunction. The primary endpoint is expected to measure the cognitive functions post injury. The Company currently intends to initiate a similar pre-clinical study in small animals towards the end the third quarter, 2017, or early fourth quarter 2017, which is materially on track with our earlier disclosed estimate.

In other industry news, other financial results and market performance of note: 

Zynerba Pharmaceuticals Inc. (NASDAQ: ZYNE) closed up 21.21% on Wednesday at $7.60 with over 4.2 million shares traded by the market close and was further up slightly in afterhours trading. The company recently announced top-line results from its double-blind placebo controlled Phase 2 STAR 1 (Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy) clinical trial evaluating ZYN002 (cannabidiol [CBD] gel) in adult epilepsy patients with focal seizures.

GW Pharmaceuticals plc (NASDAQ: GWPH) recently announced financial results for the third quarter ended 30 June 2017. "I am pleased to report the NDA submission process for Epidiolex is now underway with the final sections of the submission expected to be completed in October. With a clear view now towards our anticipated approval, we are making excellent progress with preparations to ensure a highly successful launch in 2018," stated Justin Gover, GW's Chief Executive Officer. "Following the recent publication of our first Phase 3 trial in The New England Journal of Medicine, we look forward to additional Epidiolex data publications and presentations in the second half of the year.

Read the full release here:

INSYS Therapeutics Inc. (NASDAQ: INSY) also recently announced financial results for the three-month period ended June 30, 2017. Net revenue for the second quarter of 2017 was $42.6 million, compared to $69.2 million for the second quarter of 2016. The results reflect a decline in Subsys® (fentanyl sublingual spray) prescription volumes due to softness in overall demand in the TIRF category. Gross margin was 91% for both the second quarter of 2017 and 2016.

Read the full results here:

22nd Century Group Inc. (NYSE: XXII) was up in afterhours trading on Wednesday after announcing the Company's second quarter 2017 financial results and will provide a business update for investors on a conference call to be held Thursday, August 10th, at 4:15 PM (Eastern Time). Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group, together with John T. Brodfuehrer, Chief Financial Officer, will conduct the call. Interested parties are invited to participate in the call by dialing: (800)-344-6491 and using Conference ID 9326956. The conference call will consist of an overview of recent business highlights and a summary of the financials presented in the Company's second quarter 2017 Form 10-Q. Immediately thereafter, there will be a question and answer segment open to all callers. Although 22nd Century has not yet received revenues from licensing or broad commercial sales of the Company's proprietary Very Low Nicotine tobacco - which are expected to be considerable - sales of the Company's conventional products continue to grow impressively. Second quarter results show that 22nd Century is already experiencing the benefits of newly signed manufacturing agreements. Revenue for the second quarter of 2017 increased to approximately $3.9 Million - a 37.8% increase over the revenues for the second quarter of 2016 and the highest quarterly revenue in the Company's history. 22nd Century projects that year-end revenue will exceed $16 Million - a new record for the Company.

DISCLAIMER: (MNU) is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. MNU is NOT affiliated in any manner with any company mentioned herein. MNU and its affiliated companies are a news dissemination solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. MNU's market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release. MNU is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. For current services performed MNU has been compensated thrirty-nine hundred dollars for news coverage of the current press release issued by Therapix Biosciences Ltd. by a non-affiliated third party. MNU HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.

This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and MNU undertakes no obligation to update such statements.

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