Intec Pharma Ltd. (NASDAQ: NTEC) (“Intec” or “the Company”) today announces financial results for the three and six months ended June 30, 2019.
Highlights of the second quarter 2019 and recent weeks include:
- Completed the qualification studies for the commercial scale manufacture of Accordion Pill®-Carbidopa/Levodopa (AP-CD/LD) with LTS LohmanTherapie-Systeme;
- Announced topline results from the Company’s pivotal Phase 3 trial (the ACCORDANCE trial) evaluating the safety and efficacy of the AP-CD/LD compared with immediate release CD/LD (IR-CD/LD; Sinemet®) as a treatment for the symptoms of advanced Parkinson’s disease (PD), reporting that AP-CD/LD provided treatment for Parkinson’s disease symptoms but did not demonstrate statistically superiority to IR-CD/LD in terms of reduction in OFF time from baseline under the conditions established in the protocol;
- Completed the pharmacokinetic (PK) study of the custom-designed AP developed for a proprietary compound under the previously announced feasibility and option agreement with Novartis Pharmaceuticals;
- Entered into an agreement with Merck to explore using the AP platform for an undisclosed development program;
- Published a review highlighting the benefits of the AP oral drug delivery platform in the peer-reviewed journal, Therapeutic Delivery;
- Published the results from an earlier Phase 2 clinical study of the AP-CD/LD in PD patients in the peer-reviewed journal, Parkinsonism and Related Disorders;
- Presented data from the PK study of AP-CD/LD 50/500 mg TID in a poster at the XXIV World Congress on Parkinson’s Disease and Related Disorders; and
- Granted European patent titled, “Delivery Device for Oral Intake of an Agent,” which covers Intec’s gastro-retentive drug delivery device with perforated external film.
“We were very disappointed that the ACCORDANCE study did not meet its target endpoints. In our preliminary review of the top-line data, we noted sub-sets of patients that performed particularly well, showing meaningful reduction in OFF time compared with IR-CD/LD. Based on our preliminary review, we believe we may not have been able to administer enough LD to certain patients as it was agreed with the U.S. Food and Drug Administration (FDA) that the maximum dose would be three APs per day. Given the long-term safety profile established by this trial, we believe this limitation should be removed and that this could present a method of providing additional LD to those patients who need it. We believe the on-going analyses of this study will lead to an improved understanding of what will be required in future studies to generate approvable clinical data with the AP delivery platform in PD,” stated Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma.
“During the second quarter, we made significant progress advancing and expanding our partner-sponsored programs. We are excited to have successfully completed the PK study for our custom-designed AP for Novartis’ proprietary compound and are looking forward to advancing this program into potential partnership discussions. This partnership holds significant promise as the market opportunity for this proprietary compound is in excess of $1 billion. In addition, we entered into a research collaboration with Merck for the development of a custom-designed AP for one of Merck’s proprietary compounds and are now initiating the design and construction of this new AP for this very promising program.
“We continue to make progress refining the AP for our cannabis program and hope to advance our proprietary AP containing synthetic tetrahydrocannabinol (AP-THC), one of the primary cannabinoids contained in cannabis, into a new PK study next year. The Accordion Pill has the potential to address several major drawbacks of current methods of use and treatment with cannabis and cannabinoids, such as short duration of effect, delayed onset, variability of exposure, variable potency batch to batch, variability of the administered dose and adverse events that correlate with rate of rise and peak levels. Given the known analgesic properties of cannabinoids, we remain enthusiastic about the potential for these programs and believe our AP-cannabinoids will be applicable to a variety of pain indications.
“While the ACCORDANCE results were not what we expected, we continue to believe in the potential of the AP platform. Toward that end, we plan to seek to move forward with a commercial agreement with Novartis. In addition, once we obtain the final data from our ACCORDANCE study, we plan to look for ways to advance this program forward, whether on our own or through a potential partnership. In tandem, we plan to continue to build our AP drug delivery platform with the addition of both partner-sponsored R&D programs, such as Novartis and Merck, and through internally led drug reformulation programs, such as our cannabis program in pain indications. We believe this strategy provides the best opportunities for both short- and long-term growth,” concluded Mr. Meckler.
Financial Highlights for the Three and Six Months Ended June 30, 2019
Research and development expenses, net, for the three-month period ended June 30, 2019 were approximately $7.9 million, a decrease of approximately $500,000, or 6%, compared with approximately $8.4 million for the second quarter of 2018. Research and development expenses, net, for the six-month period ended June 30, 2019 amounted to approximately $16.4 million, a decrease of approximately $900,000, or 5%, compared with approximately $17.3 million in the six-month period ended June 30, 2018. The decrease in both periods was primarily due to a decrease in expenses related to our ACCORDANCE study and open label extension study, offset by an increase in expenses related to the scale up activities for the commercial-scale production capabilities for AP-CD/LD at LTS.
General and administrative expenses for the three-month period ended June 30, 2019 were approximately $2.1 million, a decrease of approximately $100,000 or 5%, compared with approximately $2.2 million in the three-month period ended June 30, 2018. General and administrative expenses for the six-month period ended June 30, 2019 amounted to approximately $4.3 million, an increase of approximately $200,000, or 5%, compared with approximately $4.1 million in the six-month period ended June 30, 2018. The increase in the six-month period was primarily related to the increase in payroll and related expenses mainly due to an increase in headcount and salary raises and insurance expenses, offset by a decrease in professional services.
Net loss for the three-month period ended June 30, 2019 was approximately $10.0 million, compared with a net loss of $11.0 million in the prior year’s second quarter. Net loss for the six-month period ended June 30, 2019 was $20.7 millioncompared with $21.8 million during the six-month period ended June 30, 2018.
Loss per ordinary share for the three-month period ended June 30, 2019 was $0.30 compared with a loss per ordinary share of $0.34 for the three-month period ended June 30, 2018. Loss per ordinary share for the six-month period ended June 30, 2019 was $0.62 compared with a loss per ordinary share of $0.75 for the six-month period ended June 30, 2018.
As of June 30, 2019, the Company had cash and cash equivalents and marketable securities of approximately $21.6 million compared with approximately $40.6 million at December 31, 2018.
Net cash used in operating activities during the six-month period ended June 30, 2019 was approximately $17.7 millioncompared with net cash used in operating activities of approximately $19.9 million during the six-month period ended June 30, 2018. This decrease resulted primarily from the decrease in the net loss for the period in the amount of $1.1 million and from changes in operating assets and liabilities items of approximately $300,000.
The Company had negative cash flow from investing activities of approximately $1.0 million during the six-month period ended June 30, 2019 compared to negative cash flow from investing activities of approximately $4.3 million during the six-month period ended June 30, 2018. This decrease resulted primarily from a decrease in purchase of property and equipment in the amount of approximately $2.5 million, an increase in proceeds from the disposal of marketable securities in the amount of approximately $576,000 and a decrease of approximately $261,000 in investment in other assets related to the establishment of the commercial scale production capabilities for AP-CD/LD at LTS.
Net cash provided by financing activities during the six-month period ended June 30, 2019 was approximately $268,000, which was provided by the proceeds from the exercise of options by employees. Net cash provided by financing activities for the six months ended June 30, 2018 was approximately $35.0 million which was mainly provided by funds received from our April 2018 public offering of ordinary shares.
SOURCE Intec Pharma Ltd.
Medicine Man Technologies to Present at Benzinga Cannabis Capital Conference
On the first anniversary of Canadian cannabis legalization, “Legalization 2.0” or “Cannabis 2.0” will allow popular cannabis derivatives like edibles, infused beverages, and vapes to legally be bought and sold nationwide. Demand for these products is incredibly high, and most analysts believe that cannabis derivatives will allow companies to deliver on ambitious revenue projections for the still-growing pot industry. Because this market is so important, companies that are prepared to capitalize on cannabis-derived consumables—like BevCanna Enterprises Inc. (CSE:BEV) (OTCPK:BVNNF), MediPharm Labs Corp. (TSX:LABS) (OTCQX:MEDIF), Cronos Group (TSX:CRON) (NASDAQ:CRON), Valens GroWorks (TSXV:VGW) (OTCQX:VGWCF), and IAnthus Capital Holdings, Inc. (CSE:IAN) (OTCQX:ITHUF)—are likely to ride the new wave of legalization and become the major industry players of tomorrow.
According to a comprehensive report from Deloitte called Nurturing New Growth: Canada Gets Ready for Cannabis 2.0, the Canadian market for edibles and alternative cannabis products will be worth $2.7 billion annually. $1.6 billion of that will be from edibles alone, and $529 million will be from beverages.
BevCanna is Best Positioned to Deliver Cannabis Beverages
BevCanna Enterprises Inc. (CSE:BEV) (OTCPK:BVNNF) understands better than perhaps any other company what kind of opportunity “legalization 2.0” provides for the cannabis industry. With its goal to become the global leader in cannabis-infused drinks, BevCanna has done an exceptionally good job of preparing itself for the new consumables market.
The last few months have seen a bevvy of activity for BevCanna. The company recently completed independent lab testing on its proprietary powder ingredient, Deeper Green, which allows for a full range of cannabinoid inputs, including THC, CBD, full-spectrum extracts and hemp-based CBD. The company also has an exclusive supply agreement with Nextleaf Solutions to employ its water-soluble cannabinoids for development and manufacturing, as well as a research license allowing BevCanna to look into the stability and homogeneity of water-soluble cannabinoid infusions in water-based beverages.
All this means that BevCanna has the technology and the permits in place to deliver cannabis drinks that are both high-quality and reliable. Accomplishing just one of these tasks is a monumental achievement, but having both in place in time for “legalization 2.0” puts the company in an industry-leading position.
BevCanna Enterprises Inc. (BEV-BVNNF)‘s two announced products lines, Anarchist Mountain Beverages and Grüv Beverages provide the company with brands that are broadly appealing for consumers interested in cannabis drinks. Anarchist Mountain is a line of THC-dominant sparkling spring water beverages with botanical flavor profiles inspired by the Pacific Northwest. Grüv is a wide range of easy-drinking cannabis-infused iced tea drinks with a balanced CBD and THC profile. Additionally, BevCanna is in “the final development stage for a third product line that will be the catalyst for the launch of the company’s water-soluble powder beverage line in California,” according to its corporate update.
At the beginning of October, the company entered into a definitive agreement with Higharchy Ventures to manufacture and launch a portfolio of cannabis-infused beverage brands for the Canadian market. The brands will be distributed throughout Canada via Higharchy’s retail cannabis network, and as part of the rollout, BevCanna plans to establish a retail education and training program. This program will focus on educating store staff on the infused beverage category and responsible consumption.
Also, in its recent corporate update, BevCanna Enterprises Inc. (CSE:BEV) (OTC:BVNNF) laid out its objects for the next six months, which mostly center on forming relationships with LPs looking to enter the infused products market in Canada, as well as forming strategic relationships with companies and brands that offer complimentary products.
Already, 11% of Canadians consume cannabis products like edibles and infused beverages, and according to the Deloitte report, another 13% are expected to start buying them when they become legal. With nearly one in four citizens in Canada currently or likely to consume cannabis edibles and alternative products, Deloitte says that “legalizing these products should clearly create valuable new growth opportunities for Canada’s cannabis sector.”
Other Companies That Can Deliver Products to a Hungry Market
BevCanna Enterprises Inc. (BEV-BVNNF) won’t be the only company to benefit from “Legalization 2.0.” Many of its contemporaries are working hard to establish themselves in the newly legal markets.
In preparing for the new legislation governing cannabis derivatives, MediPharm Labs Corp. (TSX:LABS) (OTCQX:MEDIF) VP of investor relations & communications Laura Lepore says that her company is building “the largest vape pen platform in all of Canada.” A big part of that is the company’s white label agreement with Ace Valley, which in signed in June, to launch a premium line of approximately 2 million Ace Valley-branded cannabis extract-based vape pens to Canadian consumers.
MediPharms has also signed a manufacturing agreement with Cronos Group (TSX:CRON) (NASDAQ:CRON), which will see the company produce high-quality cannabis concentrate filled vapes for Cronos Group’s COVE brand. Vape pens have been called the key to Cronos Group’s success, and its Cronos Device Labs in Israel—which is focused on developing vape products for cannabis applications—could just be the driving force to make Cronos a leader in the vape pen category.
Not to be outdone, Valens GroWorks (TSXV:VGW) (OTCQX:VGWCF) is making sure it remains the go-to cannabis extraction company as legalization 2.0 impacts the industry. Valens already lists major market players such as Canopy Growth, HEXO, and The Green Organic Dutchman among its clientele, and to make sure that it can meet the demand for cannabis extracts once edibles can be produced and sold, it has increased its annual extraction capacity to 425,000 kgs of dried cannabis and hemp biomass.
Like MediPharm and BevCanna Enterprises Inc. (BEV-BVNNF), Valens also entered a white-label contract that will see it produce a minimum of 2.5 million THC and CBD infused beverages over five years for Iconic Brewing.
While those companies prepare to capture the burgeoning cannabis consumables market in Canada, IAnthus Capital Holdings, Inc. (CSE:IAN) (OTCQX:ITHUF) hopes to take a similar approach in the US market wherever it can. According to its Q2 financial earnings report, the company can sell extracts such as vape cartridges, edibles, waxes, and tinctures in the state of Arizona. IAnthus also increased its production by 30 percent in Q2 over the previous quarter and is planning to use this added capacity to fuel rollouts in New York, New Jersey, and Massachusetts.
The Growing Market for Cannabis Consumables and Extracts
A survey conducted by Ernst & Young found that once cannabis products like gummies and face creams become available, they will attract as many as 3 million new Canadian consumers to the market.
Outside of Canada, the market for cannabis consumables is growing exponentially. According to Zion Research, the global market for cannabis beverages is going to grow in value from 1.6 billion to $4.5 billion in 2025, at a CAGR of approximately 15%. Meanwhile, Arcview projects that the edibles market could be worth over $4.1 billion in just Canada and the United States by 2022.
BevCanna Enterprises Inc. (BEV-BVNNF) has made sure it can capitalize on the markets created by “Legalization 2.0.” It will do this through its multiple agreements to test, manufacture, and supply pot beverages, both for its own brands and for clients.
It will be joined in the new markets by MediPharm Labs Corp. and its partner Cronos Group, as well as Valens GroWorks
Sunniva Announces Amendment Of Performance Warrants
Sunniva Inc. (“Sunniva” or the “Company”) (CSE:SNN) (OTCQB:SNNVF), a North American provider of cannabis products and services, announces that it is amending the terms of the 718,249 performance warrants (the “Performance Warrants”) issued in conjunction with the acquisition of LTYR Logistics, LLC (“LTYR”) on December 31, 2018. The Performance Warrants are convertible into 718,249 common shares of the Company (“Performance Shares”) upon the satisfaction of certain operational milestones (the “Milestones”).
The Performance Warrants will be amended by replacing the original Milestone of opening a distribution business at the Company’s facility in Long Beach, California with the opening of a distribution business at the Company’s facility in Coachella, California. Upon amendment of the Performance Warrants, the Milestones will be satisfied and the Company will convert the Performance Warrants into Performance Shares.
The amendment of the 239,491 Performance Warrants held by Mr. Kevin Wilkerson, President of the Company and the former CEO of LTYR, is considered to be a “related party transaction” within the meaning of Multilateral Instrument 61-101 Protection of Minority Security Holders in Special Transactions (“MI 61-101”). The Company is relying on the exemptions from the formal valuation and minority shareholder approval requirements of MI 61-101, as neither the fair market value of the subject matter of, nor the fair market value of the consideration from, the amendment of the Performance Warrants held by Mr. Wilkerson, exceeds 25% of the Company’s market capitalization.
For more information please visit: www.sunniva.com.
To be added to the Sunniva email distribution list please register at www.sunniva.com/email-alerts.
The Canadian Securities Exchange does not accept responsibility for the adequacy or accuracy of this release.
SOURCE Sunniva Inc.
Employers still face cannabis-related challenges, a year after legalization
Employers are still facing challenges related to cannabis in the workplace a year into legalization, finds a new survey by the Canadian Federation of Independent Business (CFIB). In fact, nearly six in 10 business owners rank their provincial government’s efforts to educate them as poor or very poor.
“Cannabis legalization posed some major new challenges for employers, especially in industries where the safety of employees or customers is a concern. We warned governments in the lead-up to legalization that their education efforts were severely lacking. A year in, and as new products become available, it doesn’t look like it’s gotten much better,” said CFIB president Dan Kelly. “We’re finding that provincial governments still have not done a great job of informing employers of their responsibilities, relevant rules and regulations, as well as the resources available to them.”
Only 8 per cent of surveyed businesses had experienced a cannabis-related incident in the workplace since October 17, 2018, but that number rises to 22 per cent for businesses with 100 to 499 employees, according to the preliminary data. Businesses in hospitality were most likely to report having had an incident (16 per cent).
The survey also found that:
- Only a quarter of businesses list their provincial government as a primary source of information related to cannabis in the workplace.
- 32 per cent listed CFIB as a primary source of information, while 48 per cent did not have a primary source of information.
- 59 per cent of those who had a primary source of information felt better equipped to deal with cannabis in the workplace.
- 34 per cent of businesses do not have a drug and alcohol policy in place.
“Many small businesses don’t have an HR department or legal experts on staff so they need help and resources, but too often, their needs are treated as an afterthought when governments rush to introduce major new legislation,” added Kelly. “I advise any business owners that are looking for information to visit cfib.ca/cannabis for tools and resources, including a free workplace drug and alcohol policy template.”
SOURCE Canadian Federation of Independent Business
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