Zynerba Archives - Green Market Report

Debra BorchardtDebra BorchardtAugust 6, 2019
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4min4400

Australian-based Zynerba Pharmaceuticals Inc. (ZYNE) delivered second-quarter results and updates on the company’s drugs including its CBD (cannabidiol) gel. The general and administrative expenses for Zynerba during the second quarter of 2019 were $3.3 million, including stock-based compensation expense of $0.8 million. The net loss for the second quarter of 2019 was $11.1 million with a basic and diluted net loss per share of $(0.50).

The company announced that the U.S. Patent and Trademark Office issued U.S. Patent No. 10,314,792 titled “Treatment of Autism Spectrum Disorder with Cannabidiol” which includes claims directed to methods of treating autism spectrum disorder by administering a therapeutically effective amount of synthetic cannabidiol. This new patent expires in 2038 and is part of an expanding intellectual property portfolio covering Zygel.

“The past few months have been very productive for our team,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “We initiated new studies in autism spectrum disorder and 22q11.2 deletion syndrome, obtained Fast Track Designation for Zygel™ in FXS, enhanced our senior management team with two excellent additions in Medical and Regulatory, received an important new patent for CBD, and were added to the Russell 2000® and 3000®indices. We also extended our cash runway into the second half of 2021 through the addition of $27.0 million in cash from our ATM in the second quarter and a positive decision from the Australian government that will provide us access to an incremental $7.0 to $9.0 million in research and development cash credits. This all sets the stage for the next 12 months to be potentially transformational as we report out on our FXS pivotal trial, and our Phase 2 trials in DEE, ASD and 22q.”

The company also noted that it was added as a member of the U.S. all-cap Russell 3000 and small-cap Russell 2000 Indexes at the conclusion of the 2019 Russell indexes annual reconstitution at the open of the U.S. markets on July 1, 2019

Anido added, “Regarding the CONNECT-FX study, we believe that pivotal data will now be available in the first half of 2020. We are thrilled with the interest in this study by families who have children with Fragile X syndrome, our investigators, and our advocacy partners. The study design includes specific entrance criteria that have resulted in a higher than predicted screen failure rate. Importantly, these entrance criteria have resulted in an enrolled population with more severe behavioral symptoms than the FAB-C study population. We believe this will enhance the study’s ability to demonstrate a strong signal of activity and minimize response variability.”

Outlook

Zynerba’s cash and cash equivalent position as of June 30, 2019, was $88.7 million. Management said that it believes that the cash and cash equivalent position including proceeds anticipated from the Australian AOF is enough to fund operations and capital requirements beyond the expected NDA submission and potential approval of Zygel in FXS and into the second half of 2021.


StaffStaffFebruary 26, 2019
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6min7100

It’s time for your Daily Hit of cannabis financial news for February 26, 2019.

On The Site

GW Pharmaceutical

GW Pharmaceuticals plc (NASDAQ: GWPH) announced its financial results for the quarter ending December 31, 2018 reflecting the company’s first sales of its cannabis drug Epidiolex. The stock jumped almost 8% in after-hours trading as the biotech company beat analyst estimates. Net sales began on November 1 and between that day and the end of the year, the company logged sales of $4.7 million.

GW Pharmaceuticals changed its fiscal year to begin on January 1, 2019. The revenue for the quarter was $6.7 million versus $4.0 million for the same time period in 2017.  The average estimate for revenues from Yahoo Finance was $5.35 million.

Zynerba

Zynerba Pharmaceuticals, Inc. (ZYNE) stock popped over 8% in early trading to lately trade at $5.45 after the company announced that it had received a patent covering the company’s CBD gel.

The company said in a statement, “The U.S. Patent and Trademark Office has issued US Patent No. 10,213,390, titled “Treatment of Fragile X Syndrome with Cannabidiol” which includes claims directed to methods of treating Fragile X Syndrome by administering a therapeutically effective amount of synthetic or purified cannabidiol. This new patent, which expires in 2038, is part of an expanding intellectual property portfolio covering the Company’s cannabidiol (CBD) product candidate, ZYN002 Transdermal CBD gel.”

In Other News

Purpose Investments Inc. announced the performance of Purpose Marijuana Opportunities Fund (the “Fund”) following the one-year anniversary of its inception. The Fund (NEO: MJJ) returned 53.43% over the period from January 31, 2018 to January 31, 2019, easily outperforming the Solactive North American Marijuana Index during the same period.

“The performance of Purpose Marijuana Opportunities Fund shows exactly why we believe active management is the most optimized way to invest in the cannabis sector,” said Greg Taylor, Chief Investment Officer of Purpose Investments and Portfolio Manager for the Fund. “Passive investing in a new industry, such as marijuana, often means chasing or missing opportunities because the indexes are rebalancing much more slowly than the market itself is moving. On the other hand, active investing allows you to capitalize on all of the opportunities while properly managing risks through a variety of different strategies and tactics.”

Marijuana Company Of America Inc.  (OTCQB: MCOA) announced that the United States Patent and Trademark Office issued the Company a patent for the formulation of its flagship CBD product, hempSMART Brain. hempSMART Brain is a wellness product formulated with a proprietary composition of natural ingredients and cannabidiol (CBD) for the enhancement of brain function. The U.S. Patent Office issued patent number 10,201,553. To view the patent on hempSMART™ Brain visit the link here.

Liht Cannabis Corp. (CSE: LIHT) (OTCQX: LIHTF) provided an “in-progress” update on the company’s first harvest in Las Vegas, Nevada. Kurt Keating, Director of Operations, reports, that the team has harvested close to 1000 plants to date, producing over 335 lbs of wet weight.  They are on schedule to complete the last two rooms by March 6th. The crop strains are: Bubba Kush, Moonshine Ghost Train Haze, Amherst Sour Diesel, Skywalker and Lemon Skunk.

Green Growth Brands, Inc. (CSE: GGB) (OTCQB: GGBXF) appointed Randy Whitaker as Chief Operating Officer, a new position within GGB. Mr. Whitaker has over 27 years’ experience in real estate, finance, and store operations.  Mr. Whitaker joins GGB from Belk, Inc. a privately held department store with over 293 locations.

Organigram Holdings Inc. (TSX VENTURE: OGI) (OTCQX: OGRMF) signed a letter of intent with the Société québécoise du cannabis (SQDC). This agreement solidifies the company’s position as a true national player in Canada’s legal adult use recreational cannabis marketplace. Organigram now has distribution in place for all ten Canadian provinces.


Debra BorchardtDebra BorchardtFebruary 26, 2019
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3min8710

Zynerba Pharmaceuticals, Inc. (ZYNE) stock popped over 8% in early trading to lately trade at $5.45 after the company announced that it had received a patent covering the company’s CBD gel.

The company said in a statement, “The U.S. Patent and Trademark Office has issued US Patent No. 10,213,390, titled “Treatment of Fragile X Syndrome with Cannabidiol” which includes claims directed to methods of treating Fragile X Syndrome by administering a therapeutically effective amount of synthetic or purified cannabidiol. This new patent, which expires in 2038, is part of an expanding intellectual property portfolio covering the Company’s cannabidiol (CBD) product candidate, ZYN002 Transdermal CBD gel.”

The company said that the issuance of this patent comes as enrollment progresses in CONNECT-FX, a pivotal, multi-national, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of ZYN002 in three through 17-year old FXS patients with a full mutation of the FMR1 gene. The primary endpoint is the change from baseline to the end of the treatment period in the Aberrant Behavior Checklist-Community FXS Specific (ABC-CFXS) Social Avoidance subscale.

Zynerba said in a statement that clinical investigative sites are enrolling patients in the United States, Australia, and New Zealand. Patients who have completed the double-blind phase are now enrolling into the 12-month open-label phase. The company expects to report top-line data in the second half of 2019.

This follows the company recent news that the International Intellectual Property Organization issued a patent on a Zynerba’s CBD-based drug to treat osteoarthritis. Zynerba had conducted a study that showed that CBD could be an effective treatment for patients suffering from osteoarthrits. The administration of a CBD transdermal gel showed an improvement in pain. This patent will allow Zynerba to tap into a large osteoarthritis market occupied primarily by opioids

2018 wasn’t especially kind to Zynerba. It’s failed ZYN001 drug was a huge setback. Then the company’s stock offering was met with dismay by investors. Many felt the company had enough cash to see it through additional R&D and that it didn’t need to add more shares to the mix. Zynerba planned to use the net proceeds of the offering to support the clinical development of ZYN002

 


William SumnerWilliam SumnerNovember 8, 2018
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4min5071

The biopharmaceutical companies Zynerba Pharmaceuticals Inc. (NASDAQ: ZYNE) and Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) today posted their financial results for the third quarter, which ended on September 30, 2018. In the results, both companies glossed over their less than stellar financial situation, opting instead to highlight their clinical achievements over the last quarter.

Zynerba Pharmaceuticals

Over the last quarter, Zynerba was able to raise approximately $29.9 million through a follow-on public offer. The company has approximately $66.2 million in cash and cash equivalents, slightly down from $66.5 million at the start of the year. Company management believes that this is sufficient capital for the company to continue operations into at least the first half of 2020. Net losses for the quarter were down, falling from $8.31 million during the same period in the previous year to $7.8 million. The net loss per share, basic and diluted, was $0.47. “The momentum we established in the first half of 2018 continued through the third quarter,” commented Armando Anido, Chairman and CEO of Zynerba. “We began enrolling patients into CONNECT-FX, our pivotal study in Fragile X syndrome and we expect to complete enrollment in BELIEVE-1, our Phase 2 study in developmental and epileptic encephalopathies, before year end. With our third quarter 2018 follow-on offering, we are well capitalized and expect our current cash to take us through the presentation of top line data for both of these studies.”

Corbus Pharmaceuticals

Losses for the company increased over the last quarter, rising from $6.9 million in the same period in the previous year to $14.6 million. Revenue for the quarter rose, but not nearly enough to cover its losses; increasing from $0.3 million to $1.1 million. The increase in revenue was attributed to a $25 million Development Award Agreement with the Cystic Fibrosis Foundation. However, operating expenses also rose, going from $8.2 million to $16 million; which was attributed to increased spending for clinical studies. Currently, Corbus has $55.7 million in cash and cash equivalents. Combined with the grant from the Cystic Fibrosis Foundation, the company believes that it has enough capital to continue operating until the fourth quarter of 2019. “Our expanded pipeline of ECS-targeting drug candidates is now diversified with lenabasum, our lead late-stage clinical asset in four rare inflammatory indications with expected clinical read-out in 2020, together with CRB-4001, which is expected to enter the clinic in 2019 as a novel candidate for nonalcoholic steatohepatitis, or NASH,” said Corbus CEO, Yuval Cohen, Ph.D. “We have progressed in securing a platform for potential future growth for our Company from our library of over 600 compounds targeting ECS pathways.”


Debra BorchardtDebra BorchardtAugust 2, 2018
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4min7660

Zynerba Pharmaceuticals Inc. (ZYNE) reported a net loss of $12 million and a diluted net loss per share of $(0.89) for the second quarter ending June 30, 2018. General and administrative expenses were $3.4 million, including stock-based compensation expense of $1.0 million. Research and development expenses for the second quarter of 2018 were $8.5 million, including stock-based compensation of $0.8 million.

The company is still sitting in a solid cash position with $43.1 million, compared to $52.1 million as of March 31, 2018. On July 24, 2018, the company closed a follow-on offering selling 4,062,500 shares of common stock at an offering price of $8.00 per share, resulting in net proceeds of $30.0 million after deducting underwriting discounts and commissions and offering expenses. According to the company statement, Zynerba has also granted the underwriters a 30-day option to purchase up to 609,375 additional shares of common stock at the public offering price, less underwriting discounts and commissions, which expires on August 19, 2018. Zynerba intends to use the net proceeds of the proposed offering to support the clinical development of ZYN002, for additional research and development, and for general corporate purposes.

“Our strong clinical and corporate momentum continued over the past few months, including initiating CONNECT-FX, a pivotal study in Fragile X syndrome, and the BELIEVE 1 study in developmental and epileptic encephalopathies,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “We presented exciting new data from the ongoing FAB-C study highlighting significant and sustained improvements in behavioral symptoms of FXS in children and adolescents treated with ZYN002 out to 38 weeks. Importantly, we closed a follow-on offering on July 24th, which added $30 million to our cash position. We believe this extends our cash runway into the first half of 2020, past the top-line results from the CONNECT-FX and BELIEVE-1 studies. Assuming positive results in CONNECT-FX and supportive regulatory interactions, we believe the additional capital will fund our NDA filing for ZYN002 for the treatment of behavioral symptoms of Fragile X.”

ZYN002

The stament gave an update on the company’s main drug at this time ZYN002. “Adult refractory focal seizure patients administering transdermal ZYN002 in STAR 1 and STAR 2 showed continued reductions in focal seizures compared to baseline through 12 months of treatment. ZYN002 was well tolerated. These data continue to suggest the potential for ZYN002 in the treatment of epilepsy, and provide insight into the design of the upcoming double blind, placebo controlled Phase 2b study, which the Company expects to initiate in the second half of 2018.”

Stock Performance

Zynerba stock was sliding this morning following the earnings announcement. The biotech company has had a difficult year. It’s failed ZYN001 drug was a huge setback. Then the company’s stock offering was met with dismay by investors. Many felt the company had enough cash to see it through additional R&D and that it didn’t need to add more shares to the mix.

Zynerba has also burned through a tremendous amount of cash. In a handful of quarters, it has gone from a cash position of $77 million to its current $43 million.

According to Yahoo! Finance, there are seven analysts covering the stock. Three have hold ratings, while four have buy ratings. The average price target is $19.17. The stock was lately trading at $6.35, down 1% in pre-market trading.

 


Debra BorchardtDebra BorchardtJuly 5, 2018
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4min6531

It’s time for your Daily Hit of financial cannabis news for July 5, 2018.

The markets were closed on Wednesday in honor of the Fourth of July. Because of the holiday, news has been fairly light this week and today was no exception. It feels like many companies either took the first two days of the week off or the second.

On The Site

Alberta Canada

Several cannabis companies announced signing agreements with the Alberta Gaming, Liquor & Cannabis Commission (AGLC) to supply recreational cannabis to Alberta’s private cannabis retailers and the AGLC’s online cannabis store, www.albertacannabis.org.

Alberta is Canada’s fourth most populated province and is mostly known as being the home to tourist destinations like Banff Park and Lake Louise. Its capital is Edmonton and its largest city is Calgary. The province is known as being a hub for the country’s crude oil industry

Zynerba Pharmaceuticals Inc.

Cannabinoids drug company Zynerba Pharmaceuticals, Inc. (ZYNE) reported that the top-line results from a Phase 1 clinical program studying ZYN001 failed and that it will abandon the drug and instead focus on ZYN002. The shares fell over 20% in pre-market trading, but at the open fell 16% to lately trade at $8.01.

In Other News

MedMen Enterprises Inc.

MedMen Enterprises Inc. (MMNFF) has set the opening date of its second store in Las Vegas for early October 2018. The MedMen Las Vegas Airport store is currently under construction at 4503 Paradise Road, near popular landmarks such as the Hard Rock Hotel, the Thomas and Mack Center and McCarran International Airport.

MedMen received land-use and zoning approval from the Clark County Board of County Commissioners late last month for the new site. The company expects to move an existing license to the location following customary state and local regulatory approvals.

Namaste Technologies Inc.

Namaste Technologies Inc. (NXTTF) has signed a consulting agreement with Cannbit Ltd. where Cannbit will provide domestic consulting services to Namaste that will streamline the Company’s Israeli operations, expand its platform and increase domestic revenues. Namaste’s recent announcement of its 10% investment in Cannbit, with Cannbit’s intention to publicly list on the Tel Aviv Stock Exchange, is further supported by this strategic partnership.


Debra BorchardtDebra BorchardtJuly 5, 2018
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4min7430

Cannabinoids drug company Zynerba Pharmaceuticals, Inc. (ZYNE) reported that the top-line results from a Phase 1 clinical program studying ZYN001 failed and that it will abandon the drug and instead focus on ZYN002. The shares fell over 20% in pre-market trading, but at the open fell 16% to lately trade at $8.01.

The patent-protected, pro-drug of tetrahydrocannabinol (THC) was delivered via a transdermal patch, in healthy volunteers. The program assessed the safety and pharmacokinetics in single and multiple doses of several formulations of ZYN001. The study indicated that the target blood levels of 5 to 15 ng/ml THC were not achieved. The company did say that ZYN001 was very well tolerated with minimal skin erythema and that there were no serious adverse events or discontinuations for subjects receiving ZYN001.

ZYN001 was being developed for patients with fibromyalgia and peripheral neuropathic pain. The company’s website said that “THC is a CB1 agonist which acts at many sites along pain transmission pathways, and has been shown to have an analgesic effect in chronic pain models.”

In a statement, Zynerba said, “As a result of these data, the Company will focus its development efforts and investments on the ZYN002 Fragile X syndrome, developmental and epileptic encephalopathy (DEE) and adult refractory epilepsy programs. The Company expects that this change will extend its cash runway into the second half of 2019.”

Zynerba has also had issues with its studies on ZYN002. Last year the company had to report that its Phase 2 study was not a huge success. While patients did experience a reduction in seizures, it wasn’t a big statistical difference from the placebo. The news sent shares diving to a year’s low of $5.42. Since then, value players have been pushing shares higher on hopes of positive study results.

Seaport Global and Ladenburg Thalman both gave the stock Buy rating earlier this year according to Yahoo! Finance. The stock has an average price target of $17.50.

Investors seem to be tiring of the company’s suggestions that its studies are performing well, only to find out the results are less than satisfactory. Just two months ago, Zynerba said, “Zynerba is executing on a Phase 1 program to assess multiple formulations of ZYN001, a patent-protected, pro-drug of THC delivered via a patch. The Company expects to complete this study in the first half of 2018, and assuming supportive data, move into a Phase 2 clinical trial in Tourette Syndrome late in the second half of 2018.” The phrase “assuming supportive data” implies the study is probably performing as expected.

Zynerba has also seemed to try to ride the coattails of GW Pharmaceuticals (GWPH) studies. GW Pharmaceuticals has had very successful studies with its cannabinoid drugs for epilepsy and was recently approved by the FDA for Epidiolex. Yet, Zynerba’s epilepsy drugs had not had the same success.

 

 


Debra BorchardtDebra BorchardtMay 8, 2018
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4min5560

Beleaguered biotech company Insys Therapeutics  Inc. (INSY) reported a loss of $20.4 million in the first quarter for a loss of $0.28 cents per share. Adjusted those losses ended up being $0.19 cents per share, meeting analyst expectations.

The pharmaceutical company is known for its kickback scheme on painkillers still managed to post revenue of $23.9 million, which missed the estimates for revenues of $24.7 million. Gross revenue was $38.5 million, a decrease of 26% versus last year. The drop was attributed to the decline in sales of Subsys.

Expenses rose to $19.9 million as compared to last year’s $15 million for the same time period, mostly due to increased legal expenses. Despite its legal issues, Insys has forged ahead with clinical trials for CBD oral solutions with initiations of Phase three and Phase two trials. The company is also exploring a nasal spray.

“The continued momentum in our pipeline in the first quarter of 2018 is indicative of the strong foundation we established in 2017 that will enable the company to shift its focus from opioids to become a leader in pharmaceutical cannabinoids and spray technologies,” said Insys CEO Saeed Motahari. “Our recently launched clinical trials for the use of CBD in patients with infantile spasms and Prader-Willi Syndrome, combined without collaboration with the University of California San Diego, gives us strong confidence in our future leadership position in cannabinoids to develop potential solutions for patients in need.”

Stock Performance

The stock was lately trading at $6.78, down from its 52-week high of $15.02, but above the year low of $4.02. Six analysts cover the stock with and an average price target of $8.00 according to Yahoo Finance. Two are rating the stock at Hold, two at buy and two t strong buy.

Zynerba Pharmaceuticals Inc.

Zynerba Pharmaceuticals (ZYNE) also reported its first-quarter earnings on Tuesday with a loss of $12.3 for a loss of $0.91 cents per share versus last year’s loss of $7 million for the same time period or $0.60 cents per share. Analysts has estimated the company would report a loss of $0.64 cents per share.

Research and development expenses for the quarter were $8.9 million versus last year’s $5.4 million. The company has cash and cash equivalents of $52.1 million, which Zynerba says is enough to fund operations through 2019.

“We have made significant progress on advancing our lead asset, ZYN002 transdermal CBD gel, in the first few months of 2018,” said Zynerba CEO Armando Anido. “We recently initiated our Phase 2 study of ZYN002 in patients with developmental and epileptic encephalopathies and we are preparing to initiate a single pivotal trial for Fragile X Syndrome. We expect to achieve a number of additional milestones this year, which should position us for an exciting and data-rich 2018 and 2019.”

Stock Performance

The stock fell 13% on the earnings announcement and was lately trading at $9.00, down from its year high of $20.73.


StaffStaffApril 25, 2018
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5min9510

Here’s your Daily Hit of cannabis financial news for April 25, 2018:

On The Site:

Zynerba Pharmaceuticals Inc. 

Zynerba Pharmaceuticals  (ZYNE) announced 12-month results for its cannabidiol (CBD) gel to treat adults with epilepsy. The data is being presented today at the Emerging Science session of the 2018 Annual Meeting of the American Academy of Neurology (AAN) in Los Angeles, CA. The company is saying that the data show over the long term that seizures are reduced, yet the placebo effects in the study weren’t published.

Weed Inc. 

Weed Inc (BUDZ) is a cannabis company based in Arizona and is operated by Martin, his daughter Nicole Breen and her husband Ryan Breen. The company says it is focused on the development and application of cannabis-derived compounds for the treatment of human disease. CEO Glenn Martin is now facing a new complaint by Travis Nelson, a former employee, and shareholder of Weed. He is being accused of insider trading an transporting cannabis across state lines.

In Other News:

Golden Leaf Holdings Ltd.

Golden Leaf Holdings Ltd. (GLDFF), a leading cannabis oil solutions company built around recognized brands appointed Karl R. “Rick” Miller, Jr. to the Company’s Board of Directors, effective April 17, filling a previously vacated board position. With his addition to the Board, he will join the Audit and Nomination and Compensation Committees.

General Cannabis

Lifestyle apparel manufacturer Chiefton Supply Co., a General Cannabis (CANN) company is surging into Spring 2018 with a distribution deal to supply national action sports retailer Tilly’s with its first hemp apparel brand. Customers can find the first run of Chiefton products in Tilly’s stores located in major malls from coast to coast, including Minnesota’s Mall of America, Dallas Texas’ The Galleria, Washington’s Tacoma Mall and Massachusetts’ South Shore Plaza, with more designs on the way as the season heats up.

MM Acquisition CO., LLC

MM Acquisition (MMAC) announced the official completion of its state-of-the-art indoor cultivation facility in Downtown Los Angeles. The $15.5 million, 36,000 square foot grow operation was completed in early 2018 and has just launched its first proprietary strain, Triple 7. The facility is currently growing 40 different strains and is able to produce 600-700 pounds of high-quality flower per month.

MMAC was founded by broadcasting, digital media and luxury automotive dealership entrepreneur Scott Ginsburg who saw a huge opportunity in the California cannabis market with LA at the epicenter. Ginsburg has made a significant personal investment combined with additional capital from a blue-chip group of investors that has now created a company with a state-of-the-art LA-based cultivation facility combined with its own retail dispensaries that will serve the Los Angeles market.

Honu Xpress, Inc.

Honu Xpress, Inc. announcde that on 4/20 the Company executed a binding Licensing and Service Agreement for exclusive rights to the  Mystabis inhaler technology. The rights activate after funding the transaction and meeting other customary terms.  The Mystabis Inhaler is a revolutionary patent-pending inhaler that provides pressurized metered-doses of cannabis oil directly to the lung’s capillaries with little to no exhale.


Debra BorchardtDebra BorchardtApril 25, 2018
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3min4710

Zynerba Pharmaceuticals Inc. (ZYNE) announced 12-month results for its cannabidiol (CBD) gel to treat adults with epilepsy. The data is being presented today at the Emerging Science session of the 2018 Annual Meeting of the American Academy of Neurology (AAN) in Los Angeles, CA. The company is saying that the data show over the long term that seizures are reduced, yet the placebo effects in the study weren’t published.

“These data continue to suggest that focal seizures may be reduced with longer-term exposure to transdermally-delivered CBD,” said Dr. Liza Squires, Zynerba’s Chief Medical Officer. “In this population of patients, the use of ZYN002 for an additional 12 months in STAR 2 was well tolerated and appeared to result in clinically meaningful seizure reductions both across and within the originally randomized STAR 1 groups. These data continue to provide insight into the potential for ZYN002 in certain epilepsies, and we look forward to initiating a Phase 2b study in adult refractory focal seizures in the second half of 2018.”

In the company’s latest results Zynerba said that compared to baseline, the median changes in seizure rates at months 3, 6, 9, and 12 of STAR 2 across all ZYN002-treated patients at each time point were:
— 25% reduction at month 3 (N=171)
— 36% reduction at month 6 (N=146)
— 49% reduction at month 9 (N=112)
— 58% reduction at month 12 (N=70)

Safety

Zynerba said that the ZYN002 gel was well tolerated with good skin tolerability. The company statement read, “In STAR 2, the most common treatment-emergent AEs (> 7.5%) were upper respiratory tract infection (viral and bacterial [17%]) and headache (11%). One serious AE was considered possibly related to ZYN002 (increased anxiety). There was no clinically significant abnormal liver AEs (i.e. alanine aminotransferase/aspartate aminotransferase) >3x upper limit of normal reported for patients receiving ZYN002.”

Where’s The Placebo Data?

In the STAR 1 results, Zynerba’s study was conducted during a shorter time period and the placebo results weren’t much different from ZYN002’s results. The company stated, “In STAR 1, the change in seizure frequency did not statistically differ between
placebo and both doses of ZYN002.” The placebo results in the STAR 2 study weren’t published in the one-page infographic.

 

 



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The Green Market Report focuses on the financial news of the rapidly growing cannabis industry. Our target approach filters out the daily noise and does a deep dive into the financial, business and economic side of the cannabis industry. Our team is cultivating the industry’s critical news into one source and providing open source insights and data analysis


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