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Intec Pharma Reports Second Quarter 2019 Financial Results and Business Update

Vlad Poptamas



Reading Time: 5 minutes


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.

Management Commentary

“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.


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Flower One’s Second Quarter Highlighted by Industry Leading Cultivation Performance

Vlad Poptamas



Reading Time: 3 minutes


Flower One Holdings Inc. (the “Company”) (CSE: FONE) (OTCQX: FLOOF), a leading cannabis cultivator, producer and innovator in Nevada, today reported its financial and operating results for the second quarter ended June 30, 2019. All amounts are expressed in U.S. dollars unless indicated otherwise.  Now operating in a state of ongoing weekly harvests following the completed conversion of its Nevada greenhouse and its inaugural harvest announced on June 11, 2019, the Company confirmed today that its second quarter financial and operational performance has resulted in a cultivation yield performance of 38.3 grams per square foot, per harvest cycle, at an average cost per gram of $0.45.

In addition, the Company announced that it has completed an initial harvest in all eight of its flower zones and has commenced harvesting of its second cycle of planted cannabis.   The success of its cultivation performance through the second quarter has resulted in a year-to-date tenfold increase of the Company’s biological assets and inventory to $56.1M further strengthening its balance sheet. At the quarter end, the Company held more than 14,000 pounds of dry cannabis inventory. Flower One’s dry cannabis will now transition to the Company’s 55,000 square-foot production facility to generate a wide variety of the most in demand cannabis products and brands from across the United States.

“Achieving a cultivation yield performance of 38.3 grams per square foot and doing so at a cost of $0.45 per gram, firmly establishes us as one of the leading large-scale cannabis cultivators in North America and the world,” said President and CEO, Ken Villazor.

“We are extremely proud of these results and what they signal not only for the future of Flower One, but also for our ever-expanding brand and retail partner portfolio, and valued shareholders. This clearly demonstrates our ability to fulfill our promise of providing the industry’s first seed-to-shelf solution for cannabis brands and retailers,” added Kellen O’Keefe, Chief Strategy Officer.

Other Q2 highlights:

  • Entered eighth brand partnership – plus three more subsequent to the quarter;
  • Obtained debt financing of up to $30 million to accelerate market roll-out;
  • U.S. trading upgraded to OTCQX Best Market from OTCQB in May.

Second quarter financial results

The Company’s operational activities during the quarter largely focused on advancing the conversion of its 455,000 square foot greenhouse and production facility for cultivating high-quality cannabis at scale which was completed during the quarter.

The Company recorded cannabis inventory of $25.4 million and biological assets of $30.6 million as a result of the cultivation activities during the six months ended June 30, 2019.  Additionally, the Company invested $41.0 million in property, plant and equipment primarily for the Nevada greenhouse facility.

Revenue for the quarter was $636 thousand. The Company began recording revenue on November 9, 2018 subsequent to the acquisition of the assets of NLVO. As such, there was no revenue for the comparable period of 2018. All revenue for the quarter was from the NLVO operations. The Company expects to begin earning revenue from the sale of products from its the flagship greenhouse facility starting in the third quarter.

Net income was $19.1 million mainly driven by a fair value gain of $37.3 million on the growth of biological assets, partially offset by cost of goods sold of $844 thousand and $1.8 million in losses related to fair value adjustments on derivative liabilities, $461 thousand in share-based compensation, $3.1 million in finance expenses, $796 thousand in foreign exchange loss related to the convertible debenture, derivative liabilities and the Company’s cash balances held in Canadian dollars, $3.7 million in general and administrative expenses, and tax expense of $7.9 million mainly related to the fair value gain on the growth of biological assets.

As at June 30, 2019, Flower One had working capital of $41.9 million compared to a working capital deficit of $32.9 million at December 31, 2018.

Flower One’s 2019 second quarter financial statements and management’s discussion and analysis will be issued and filed on SEDAR at on August 13, 2019 and will be available on the same day on Flower One’s website at

Notice of conference call

Management of Flower One will host a conference call at 8:30 a.m. ET on Wednesday, August 14, 2019 to review recent and upcoming milestones. You can join the call by dialing 647-427-7450 or 1-888-231-8191. Please dial 647-427-7450 or 1-888-231-8191 approximately 15 minutes prior to the call to secure a line. You will be put on hold until the conference call begins. A replay of the conference call will also be available until Wednesday, August 28, 2019. To access the archived conference call, please dial 1-855-859-2056 and enter the conference code 2435459.

A live audio webcast of the call will be available at Please connect at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to join the webcast. An archived replay of the webcast will be available for 90 days.


SOURCE Flower One Holdings Inc.

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Sunniva Provides Update On California Operations

Vlad Poptamas



Reading Time: 3 minutes


Sunniva Inc. (“Sunniva”, the “Company”, “we”, “our” or “us”) (CSE: SNN) (OTCQB: SNNVF), a North American provider of cannabis products and services, today provided an operational update and outlook for its U.S. operations.

Sunniva California Campus

The Company has recently been advised by our general contractor that connection of certain utilities to the glasshouse in Cathedral City, California have been delayed for several months. In addition, the longer than expected time to closing of the sale of Sunniva Medical Inc. to CannaPharmaRx, Inc. has limited the amount of cash available for the ongoing funding of the glasshouse which has created additional delays in the current schedule.  The expected date for onboarding of genetic material and plants for phase one of the 325,000 square foot Sunniva California Campus is now anticipated to be early 2020. The developer and Sunniva have been disappointed with the overall progress of the glasshouse. As a result, the parties have reorganized the project management team and have engaged an internationally recognized construction consulting firm to manage the project through the final stages of construction and commissioning of the facility. Both parties believe that these changes will greatly influence the ability to achieve the revised estimated time to completion.

“Today’s announcement of the deferral of our previously planned operational date is disappointing, however, we do not feel that this setback will have an impact on the long term value that may be created from the glasshouse and we remain confident that the cannabis grown in this facility will be of the highest quality in the industry.” said Dr. Anthony Holler, CEO of Sunniva.

Branded Cannabis Product Sales

The Company has been prioritizing available capital towards the completion of the glasshouse and as a result has reduced the amount of cash allocated to the purchase of biomass for use in the Company’s Extraction Facility and to the purchase of third party flower to be used in branded cannabis sales. As a result of this decision, the Company will not achieve its previously announced 2019 revenue estimate of USD$55$60 million from sales of Sunniva branded products.

Preliminary Q2 2019 Revenue

The Company is announcing preliminary revenue of $5.3 million for the three-month period ended June 30, 2019. This represents an 18% increase over the $4.5 million in revenue generated in the comparative three-month period from 2018. At the end of June 30, 2019, the Company had generated approximately $19.5 million in revenue in 2019.  Gross profit margin for the second quarter of 2019 is expected to be a loss of approximately $1 million primarily due to the lower sales of cannabis products in California, while continuing to bear the fixed operational costs of the respective facilities.

“We are pleased with the performance of our operations in the first half of the year. The $19.5 million in revenue is greater than the total revenue generated in all of 2018.” Said Kevin Wilkerson, President of Sunniva, Inc. “We have demonstrated our ability to produce large volumes of cannabis products and combined with our distribution and packaging capabilities, we have been able to successfully deliver that product into the California market.”

Further information regarding the revised timeline for expected completion of the Sunniva California Campus and an updated financial outlook for the remainder of fiscal 2019 will be provided in the Q2 2019 Earnings Release.

Q2 2019 Earnings Release Date

The Company plans to release financial results for the second quarter 2019 and provide a corporate update on its Canadian and U.S. operations, after market close on Thursday August 29, 2019.

The Company’s executive management will discuss the results during a conference call on Thursday, August 29, 2019 at 5:00 pm Eastern Time / 2:00 pm Pacific Time.  To participate in the call please dial 1-800-319-4610, or (604) 638-5340.  An audio replay will be available shortly after the call by dialing 1-855-669-9658 or (604) 674-8052 and entering code 3557.  The replay will be available for two weeks following the call.

For more information please visit:

To be added to the Sunniva email distribution list please register at

Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.


SOURCE Sunniva Inc.

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Namaste Technologies Announces Changes to Board of Directors

Vlad Poptamas



Reading Time: 1 minute


Namaste Technologies Inc. (“Namaste” or the “Company”) (TSXV: N) (FRANKFURT: M5BQ) (OTCMKTS: NXTTF) today announced that Kenneth Ngo, the Company’s Chief Financial Officer, has stepped down from the Board of Directors effective immediately.

“I wish to thank Kenneth for stepping onto the Board of Directors in December 2018 as we reshaped the Company.  With the addition of Ken Jones and Andy Wilczynski, who can provide financial expertise to the board, Kenneth has decided to step down as a board member” said Meni Morim, Interim CEO of Namaste Technologies.

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