Intec Pharma Ltd. (NASDAQ: NTEC) (“Intec” or “the Company”) today announces financial results for the fourth quarter and year ended December 31, 2019 and provides a corporate update.
Highlights from the Quarter and Recent Weeks
- Developed an Accordion Pill (AP) for a Merck & Co. (MSD) proprietary compound that met the in vitro specifications set forth in the companies’ research collaboration and are now in discussions with MSD to determine advancing the program into human pharmacokinetic (PK) studies;
- Concluded the Feasibility and Option Agreement (FOA) with Novartis Pharmaceuticals, under which Intec Pharma built a custom-designed AP for a Novartis proprietary compound that met the technical and PK clinical specifications set forth but following an internal and revised commercial strategic assessment, Novartis determined not to take the program forward;
- Novartis agreed to pay Intec Pharma $1.5 million upon conclusion of the program FOA and those funds were transferred to the Company in February 2020;
- Completed the qualifying production runs for the commercial scale manufacturing of AP Carbidopa/Levodopa (AP-CD/LD) with our manufacturing partner, LTS Lohmann Therapie-Systeme AG (LTS);
- Secured $10 million in committed financing from Aspire Capital, a long-term institutional investor; and
- Enhanced the balance sheet with a $6.5 million public offering.
“We entered 2020 with a focused agenda for leveraging our Accordion Pill platform in both the near- and long-term, with goals to outlicence our late-stage Parkinson’s disease program, to advance our research collaboration with Merck into human PK studies, to move our cannabinoid program into a second PK study and to expand our pipeline by adding new partnered programs, such as the one we have with Merck. Our team is diligently working toward executing these objectives and we look forward to achieving a number of these in the coming months,” said Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec.
“In tandem with these initiatives, we continue to work with our manufacturing partner, LTS, to advance the commercial scale production of AP-CD/LD, confident that having these critical processes in place enhances our business development efforts. We are pleased to report that LTS has completed the qualification studies for the commercial scale production and have initiated the validation and stability studies of the batches which are expected to serve as the clinical material for the next Phase 3 clinical trial plan. This is particularly beneficial for our partnering discussions for the Parkinson’s disease program.
“In addition to advances with commercial manufacturing, we continue to engage in dialogues with potential new partners. Toward that end, our business development and technical operations teams are actively participating in a number of key drug delivery conferences worldwide in the coming months. We expect the enhanced visibility for the AP and its capabilities to increase the interest in the platform among audiences seeking new technologies and improved delivery formulations.
“Importantly, we strengthened our balance sheet believing that a stronger financial position enhances our ability to negotiate with partners and provides us with a longer runway to achieve key objectives. We believe our cash will now take us into the second quarter of 2021, without tapping into our Aspire commitment,” added Mr. Meckler.
Financial Highlights for the Fourth Quarter Ended December 31, 2019
Research and development expenses, net, for the three-month period ended December 31, 2019 were approximately $1.8 million, a decrease of $8.5 million, or approximately 82.5%, compared with approximately $10.3 million in the three-month period ended December 31, 2018. The decrease was primarily due to a decrease in expenses related to the ACCORDANCE Phase 3 study of AP-CD/LD and the Open Label Extension study, both of which were completed during 2019 and a decrease 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 December 31, 2019 were approximately $1.8 million, a decrease of $300,000, or approximately 14.3%, compared with approximately $2.1 million in the three-month period ended December 31, 2018. The decrease was primarily due to a decrease in professional services and expenses related to investor relations activities. This decrease was offset by an increase in insurance expenses.
Impairment of long-lived assets was recorded as the top-line results of the ACCORDANCE trial were considered a triggering event for impairment. For the three-month period ended December 31, 2019, the Company recorded an impairment charge of approximately $3.9 million. This impairment represents the excess carrying value of the long-lived assets compared to its fair value.
The Company recorded other income for the three-month period ended December 31, 2019, of $1.5 million on conclusion of the program with Novartis.
Net loss for the three-month period ended December 31, 2019 was approximately $6.6 million, a decrease of $6.0 million, or approximately 47.6%, compared with the net loss for the three-month period ended December 31, 2018 of approximately $12.6 million. The decrease was mainly due to the decrease in research and development expenses as detailed above and the other income associated with the conclusion of the Novartis program offset by the impairment of the Company’s long-lived assets.
Loss per ordinary share for the fourth quarter ended December 31, 2019 was $0.19 compared with $0.38 for the fourth quarter ended December 31, 2018.
Financial Highlights for the Year Ended December 31, 2019
Research and development expenses, net, for the year ended December 31, 2019 were approximately $26.7 million, a decrease of $8.7 million, or approximately 24.6%, compared with approximately $35.4 million in the prior year period. The decrease was primarily due to a decrease in expenses related to the ACCORDANCE Phase 3 study of AP-CD/LD and the Open Label Extension study, both of which were completed during 2019.
General and administrative expenses for the year ended December 31, 2019 were approximately $8.3 million, an increase of $400,000, or approximately 5.1%, compared with approximately $7.9 million in the year ended December 31, 2018. The increase was primarily related to the increase in insurance expenses. This increase was offset by a decrease in professional services.
Impairment of long-lived assets was recorded as the top-line results of the ACCORDANCE trial were considered a triggering event for impairment. For the year ended December 31, 2019, the Company recorded an impairment charge of approximately $13.7 million. This impairment represents the excess carrying value of the long-lived assets compared to its fair value.
The Company recorded other income for the year ended December 31, 2019, of $1.5 million on conclusion of the program with Novartis.
Net loss for the fiscal year ended December 31, 2019 was approximately $47.6 million, an increase of $4.1 million, or approximately 9.4%, compared with the net loss for the year ended December 31, 2018 of approximately $43.5 million. The increase was mainly due to the impairment of the Company’s long-lived assets and an increase in general and administrative expenses as detailed above offset by the other income associated with the conclusion of the Novartis program and the decrease in research and development expenses, as detailed above.
Loss per ordinary share for the full-year 2019 was $1.41 compared with $1.40 for the full-year 2018.
As of December 31, 2019, the Company had cash and cash equivalents and marketable securities of approximately $10.1 million compared with approximately $40.6 million at December 31, 2018.
Net cash used in operating activities was approximately $29.0 million for the year ended December 31, 2019 compared with net cash used in operating activities of approximately $39.1 million for the year ended December 31, 2018. This decrease resulted primarily from a decrease in research and development activities in the amount of approximately $8.7 million and changes in operating asset and liability items of approximately $1.2 million.
The Company had negative cash flow from investing activities of approximately $3.2 million for the year ended December 31, 2019 compared with negative cash flow from investing activities of approximately $9.3 million for the year ended December 31, 2018. This decrease resulted primarily from a reduction of approximately $2.1 million in investment in other assets related to the establishment of the commercial scale production capabilities for AP-CD/LD at LTS and a decrease in purchase of property and equipment in the amount of approximately $3.8 million.
Net cash provided by financing activities was approximately $2.4 million for the year ended December 31, 2019 compared with net cash provided by financing activities of approximately $35.1 million for the year ended December 31, 2018. The principal source of the cash provided by financing activities during 2019 was the funds received from the Company’s “at-the-market” equity offering program of $2.1 million. The principal source of the cash provided by financing activities during 2018 was the funds received from the Company’s April 2018 underwritten public offering of ordinary shares that resulted in net proceeds of approximately $35.0 million.
In January 2020, the Company raised $6.5 million in an underwritten public offering of 16,250,000 ordinary shares (which included pre-funded warrants to purchase ordinary shares in lieu thereof) and warrants to purchase up to 16,250,000 ordinary shares, at a public offering price of $0.40 per ordinary share and warrant. The warrants have an exercise price of $0.40 per share, are immediately exercisable, and will expire five years from the date of issuance.
More detailed information can be found in the Company’s Annual Report, a copy of which has been filed with the Securities and Exchange Commission and posted on the Company’s website at www.intecpharma.com. You may request a copy of the Company’s Form 10-K, at no cost to you, by writing to the Chief Financial Officer of the Company at 12 Hartom Street, Har Hotzvim, Jerusalem 9777512, Israel or by calling the Company at +972 (2) 586 4657.
Innocan’s Over-The-Counter Pain Relief Spray Receives FDA’s Technical Validation for Marketing in the USA
Herzliya, Israel and Calgary, Alberta–(Newsfile Corp. – July 13, 2020) – Innocan Pharma Corporation (CSE: INNO) (FSE: IP4) (the “Company” or “Innocan“), is pleased to announce that it has received notice from the FDA that Innocan’s over-the-counter Relief & Go Pain Relief spray product has successfully received technical validation and approval to commence marketing in the USA. Innocan’s pain relief formulation contains a combination of Magnesium oil, Methyl salicylate, Menthol and CBD. The Relief & GO Pain Relief spray is designed to target pain-related muscle and provide relief for joint pain. The unique formulation is administered with a simple dose of spray, roll-on or lotion.
To view an enhanced version of Figure 1, please visit:
“We are excited to receive the approval from the FDA to market our flagship pain relief product in the USA” Iris Bincovich, co-founder and CEO of Innocan states and she continues: “This represents the Company’s ability to develop and practice breakthrough technologies to create new CBD based products for the growing pain relief market.”
According to the American Academy of Pain Medicine chronic pain affects approximately 1.5 billion people worldwide, and research by Prescient & Strategic Intelligence reported that “Chronic Pain Treatment Market to Reach US $105.9 Billion by 2024”.
The Company, through its wholly owned subsidiary, Innocan Pharma Ltd. (“Innocan Pharma Israel”), is a pharmaceutical tech company that focuses on the development of several drug delivery platforms combining cannabidiol (“CBD”). InnoCan and Ramot at Tel Aviv University are collaborating on a new, revolutionary exosome-based technology that targets both central nervous system (CNS) indications and the Covid-19 Corona Virus. CBD-Loaded Exosomes hold the potential to provide a highly synergistic effect of anti-inflammatory properties and help in the recovery of infected lung cells. This product, which is expected to be administrated by inhalation, will be tested against a variety of lung infections.
The Company signed on a worldwide exclusive license agreement with Yissum, the commercial arm of the Hebrew University of Jerusalem to develop CBD drug delivery platform based on a unique-controlled release Liposome to be administrated by Injection. The company plans, together with Prof. Berenholtz, Head of the Laboratory of Membrane and Liposome Research of the Hebrew University to test the Liposome platform on several potential indications. The company is also working on a dermal product integrating CBD with other pharmaceutical ingredients as well as the development and sale of CBD-integrated pharmaceuticals, including, but not limited to, topical treatments for relief of psoriasis symptoms as well as the treatment of muscle pain and rheumatic pain. The founders and officers of InnoCan have commercially successful track records in the pharmaceutical and technology sectors in Israel and globally.
For further information, please contact:
For InnoCan Pharma Corporation:
Iris Bincovich, CEO
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
Caution regarding forward-looking information
Certain information set forth in this news release, including, without limitation, the effectiveness and safety of the Company’s products, , information regarding the markets, requisite regulatory approvals and the anticipated timing for market entry, is forward-looking information within the meaning of applicable securities laws. By its nature, forward-looking information is subject to numerous risks and uncertainties, some of which are beyond InnoCan’s control. The forward-looking information contained in this news release is based on certain key expectations and assumptions made by InnoCan, including expectations and assumptions concerning the anticipated benefits of the products, satisfaction of regulatory requirements in various jurisdictions and satisfactory completion of requisite production and distribution arrangements. Forward-looking information is subject to various risks and uncertainties which could cause actual results and experience to differ materially from the anticipated results or expectations expressed in this news release. The key risks and uncertainties include but are not limited to: general global and local (national) economic, market and business conditions; governmental and regulatory requirements and actions by governmental authorities; and relationships with suppliers, manufacturers, customers, business partners and competitors. There are also risks that are inherent in the nature of product distribution, including import / export matters and the failure to obtain any required regulatory and other approvals (or to do so in a timely manner) and availability in each market of product inputs and finished products. The anticipated timeline for entry to markets may change for a number of reasons, including the inability to secure necessary regulatory requirements, or the need for additional time to conclude and/or satisfy the manufacturing and distribution arrangements. As a result of the foregoing, readers should not place undue reliance on the forward-looking information contained in this news release concerning the timing of launch of product distribution. A comprehensive discussion of other risks that impact InnoCan can also be found in InnoCan’s public reports and filings which are available under InnoCan’s profile at www.sedar.com.
Readers are cautioned that undue reliance should not be placed on forward-looking information as actual results may vary materially from the forward-looking information. InnoCan Pharma does not undertake to update, correct or revise any forward-looking information as a result of any new information, future events or otherwise, except as may be required by applicable law.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/59564
TransCanna Receives State-Wide Operating License
Now owns largest known fully licensed cannabis facilities in California
Vancouver, British Columbia–(Newsfile Corp. – July 11, 2020) – TransCanna Holdings Inc. (CSE: TCAN) (FSE: XETR) (“TransCanna” or the “Company”) is pleased to announce that its wholly-owned subsidiary, Lyfted Farms, Inc. (“Lyfted”), was successfully granted a Type 11 ‘Distributor’ license by the California Bureau of Cannabis Control for its 196,000 square foot Daly Avenue Facility.
This long-anticipated milestone marks the completion of all state and local licenses required for the Company to begin operations at its flagship cannabis processing facility in Modesto, California.
This state-wide license represents Lyfted’s most major milestone to date in meeting the distribution and production capabilities needed to meet the escalating demand for its products in the world’s largest cannabis market. The license was granted after three levels of approvals were achieved at the county and state level and will allow for the commencement of packaging, transport, wholesale, pre-roll assembly, labeling, testing, contract packaging (white-labeling), and of course distribution of cannabis products to all licensed retailers across the state.
“This is the most exciting development in our history and what everyone has been working towards,” says Bob Blink, TransCanna CEO. “Being granted a license at the state level is a long, costly, and complex process, and one that requires navigating and understanding a complex regulatory process. It’s a significant barrier to entry for most companies, so this marks a huge turning point for us. We are delighted to have achieved our biggest goal to date and excited to be able to better serve the demands of the California cannabis market.”
The Company is currently completing upgrades to the flagship Daly Facility. Commercial cannabis activities are expected to commence at Daly August 2020, via the deployment of a 16,000 square foot cannabis distribution center (Phase 1). To date, Lyfted has been able to process in excess of $1M USD/month in wholesale cannabis transactions out of a distribution space of 1,000 square feet from its Jerusalem Court facility. These upgrades will mean the Company now has 16,000 square feet of distribution space at its disposal as of August 2020.
“This exponential increase in capacity is incredibly exciting for investors,” says Blink, adding the Company has been focused on building out its wholesale and distribution business while awaiting its final license. “Having processed a million dollars’ worth of product out of a single one-thousand square foot facility, we are anticipating significant growth now that our 196,000 square foot operation is online.”
Lyfted anticipates hiring up to 250 full-time employees at the flagship site with a strong focus placed on social equity and a diverse workforce that is reflective of the communities it serves and operates in.
About TransCanna Holdings Inc.
TransCanna Holdings Inc. is a California based, Canadian listed company building cannabis-focused brands for the California lifestyle, through its wholly-owned California subsidiaries.
On behalf of the Board of Directors
Bob Blink, CEO
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.
This release includes certain statements and information that may constitute forward-looking information within the meaning of applicable Canadian securities laws or forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements relate to future events or future performance and reflect the expectations or beliefs regarding future events of management of the Company. Generally, forward-looking statements and information can be identified by the use of forward-looking terminology such as “intends” or “anticipates”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “should”, “would” or “occur”. This information and these statements, referred to herein as “forward‐looking statements”, are not historical facts, are made as of the date of this news release and include without limitation estimates and forecasts and statements as to management’s expectations for growth and the commencement of operations of the Company’s Daly facility.
The forward-looking information in this press release is based upon certain assumptions that management considers reasonable in the circumstances, including that operations will commence at the Company’s Daly facility in Modesto, California, as and when expected.
These forward‐looking statements involve numerous known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially from any future results, events or developments expressed or implied by such forward-looking statements. Risks and uncertainties associated with the forward-looking information in this news release include, among others, dependence on obtaining and maintaining regulatory approvals, including state, local or other licenses and any inability to obtain all necessary governmental approvals licenses and permits to complete upgrades to its Daly facility in a timely manner; engaging in activities which currently are illegal under U.S. federal law and the uncertainty of existing protection from U.S. federal or other prosecution; regulatory or political change such as changes in applicable laws and regulations, including U.S. state-law legalization, particularly in California, due to inconsistent public opinion, perception of the medical-use and adult-use marijuana industry, bureaucratic delays or inefficiencies or any other reasons; any other factors or developments which may hinder market growth;; reliance on management; and the effect of capital market conditions and other factors (including those related to the COVID-19 pandemic) on capital availability; competition, including from more established or better financed competitors; and the need to secure and maintain corporate alliances and partnerships, including with customers and suppliers.
Although management of the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements or forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. The Company does not undertake to update any forward-looking statement, forward-looking information or financial out-look, except in accordance with applicable securities laws.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/59555
PURA Cannabis Cultivation Spinoff and Dividend Breaking News Update
Dallas, Texas–(Newsfile Corp. – July 10, 2020) – Puration, Inc. (OTC Pink: PURA) now has the following update to the press release published this morning about the management buyout of a separate public company that will in turn purchase PURA’s cannabis cultivation spinoff in exchange for common stock scheduled to close today. The management buyout has been executed by all parties. The purchase is scheduled to be funded on Monday. The management/owner team plans to make a formal announcement on Tuesday, July 14, 2020 (the formal announcement was previously expected on Monday, but to ensure funding is complete first, the announcement is now scheduled for the next day).
PURA – Logo
To view an enhanced version of this graphic, please visit:
The common stock issued in exchange for the PURA spinoff is intended to be issued to PURA shareholders in a dividend distribution.
NCM Biotech, a subsidiary of Kali-Extracts (OTC Pink: KALY) will also be acquired and merged with PURA’s cannabis spinoff.
The management team purchasing control of the target public company is expected to confirm the planned acquisitions of PURA’s cannabis cultivation company and KALY’s NCM Biotech in the announcement now scheduled for Tuesday, July 14, 2020.
PURA’s cannabis cultivation operation is thriving. The operation has recently purchased and relocated to a new property from its former leased property. Texas lawmakers have recently implemented hemp friendly farming regulations and in so doing, universities within the State of Texas have initiated hemp farming research programs. PURA’s cannabis cultivation spinoff has initiated a number of joint research applications with Texas universities.
NCM Biotech is focused on medical research and the development of treatments derived from its patented cannabis extraction process. See a recent research report on CBD extracts derived from NCM Biotech’s patented extraction process: Journal of Cannabis Research.
For more information on Puration, visit http://www.purationinc.com
This news release contains forward-looking statements within the meaning of the Securities Litigation Reform Act. The statements reflect the Company’s current views with respect to future events that involve risks and uncertainties. Among others, these risks include the expectation that any of the companies mentioned herein will achieve significant sales, the failure to meet schedule or performance requirements of the companies’ contracts, the companies’ liquidity position, the companies’ ability to obtain new contracts, the emergence of competitors with greater financial resources and the impact of competitive pricing. In the light of these uncertainties, the forward-looking events referred to in this release might not occur. These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/59533
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