GreenBully wrote: FSD PHARMA HAS MORE THEN 20,000,000 NOW WE WAIT TO SEE HOW THEY SPEND IT VIA FINANCIALS
GOOD THINGS COME TO THOSE WHO WAIT
NOBODY KNOW'S WHEN THEY ACTUALLY START THE PHASE 2A IT COULD BE NEXT WEEK OR NEXT MONTH OR NEXT FEW MONTHS OR AFTER US ELECTION.
BIOTECH COMPANIES NEED MONEY AND THEY WERE ASSET RICH AND WERE ABLE TO SELL CANNARA BIOTECH AND ALSO RAISE $20,000,000
CASH IS KING. ULTRAMICROPEA IS USED IN ITALY FOR INFLAMMATION
NOW WE WAIT TO SEE IF IT WORKS ON COVID19 PATIENTS!!!!!!!!!!!!!!!!!!
GO BIG OR GO HOME!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
FACTS
INSIDERS LOADED UP OVER 4 MILLION OF THEIR OWN MONEY PLEASE FIND ME OTHER MICROCAP BIOTECHS THAT HAVE DONE THIS.
FDA GAVE THEM APPROVAL TO DESIGN PHASE 2A TRIAL,... MANY ARE ONLY ON PHASE 1 SO THAT SETS THEM APART FROM THE REST, MANY VACCINE COMPANIES ARE ON PHASE 2 AND 3 ALSO BUT THOSE IM NOT COUNTING , THERAPEUTICS SUCH AS ULTRAMICROPEA REACH AND STOP CYTOKINE STORM = STOP DEATH.
THIS IS HUGE AND ONLY TIME AND CLINICAL TRIALS CAN PROVE OTHERWISE YOU NEED TO HAVE STRENGTH LIKE A BULL AND PATIENCE LIKE AN OWL.
FSD PHARMA MOVED AWAY FROM CANNABIS BECAUSE IT'S BAD BUSINESS IN CANADA AND ALSO ITS FEDERALLY ILLEGAL IN USA.
FSD PHARMA IS ON NASDAQ AND THEIR MISSION IS BIOTECH.
FSD PHARMA HAD HUGE CASH BURN RATES BUT MAKING DRUGS ARE NOT CHEAP.
INSTITUTIONAL HIGHWAYS ARE HARD TO COME INTO IF YOU LOOK AT OTHER LARGE BIOTECH STOCKHOUSE BOARDS THEY DON'T EVEN HAVE MUCH COMMENTS MOSTLY BECAUSE ITS' 80 INSTITUTIONAL OWNERSHIP.
THE RISKS EXIST BUT WE MUST ACKOWLEDGE THAT FSD PHARMA MADE AMAZING MOVES SINCE 2018 AFTER THE CANNABIS BUBBLE BURST THEY MADE TOUGH CHOICE OF NOT GOING THROUGH WITH GROW FACILITY EXPANSIONS FOR 200,000 SQ FT. THEY SAID F OFF TO AUXLY BECAUSE AUXLY DIDNT FINISH THE BUILDOUT ON TIME.
THERE IS OVER SUPPLY ISSUES IN CANADA NOBODY WANTS TO SMOKE SHT WEED. BLACKMARKET THRIVES.
FORGET ABOUT CANNABIS FOR NOW UNTIL USA LEGALIZES WHO KNOWS WHEN THAT MIGHT BE I DOUBT TRUMP WILL LEGALIZE IT..
NEXT STEP. WE WAIT AND SEE HOW THE PHASE 2 A TRIAL PLAYS OUT. THERE ARE MANY BIOTECH COMPANIES ON NASDAQ THAT DO WELL. HOW MANY BILLION MARKET CAP ARE THERE BIOTECH VS CANNABIS STOCKS?
THERE IS RISKS TO ALL STOCKS BUT THE ODDS ARE GOOD FOR FSD PHARMA BECAUSE THEY HAVE A SOLID PHARMA TEAM BEHIND THEM AND THEY MEAN BUSINESS.
MANY PEOPLE MADE FUN OF RAZA BOKHARI ONLINE AND HE' IS HIGH CLASS AND DOESNT CARE WHAT PEOPLE THINK OR SAY IT SEEMS THAT HE ONLY WANTS TO FOCUS ON THE PHARMA AND THE REST WILL DO THE TALKING.
ALL FSD PHARMA INSIDER BUYING CAN BE FOUND HERE : INSIDERS SEDI
There are risks still such as will they have enough money?
Recent 20,000,000 Raise says otherwise. FSD Pharma Announces US$20M At-The-Market Offering
Will FSD Pharma pass phase 1?
FSD Pharma Reports Favorable Topline Results from Phase 1 First-in-Human Safety and Tolerability Study of Ultramicronized PEA
Will they be able to close and get institutional investment banking as promised?
FSD Pharma Announces Closing of C$10.125 Million Private Placement to Institutional Investors
FSD Pharma was able to get phase IIa approval to design a concept to treat covid19 patients this means FDA gave them the go ahead to draw out the schematics on how the phase 2 proceedure will take place. UltramicroPEA has huge safety profile behind it and is a good candidate to tackle cytokine storm that's how. It's good to pay seasoned pharmaceutical executives that know how to do this and navigate the pharma realm. FSD Pharma Receives U.S. FDA Approval to Design a Phase 2a Clinical Trial to Treat Patients with Suspected or Confirmed COVID-19 Diagnosis
Most clinical trials even though approved need a clinical setting for example, where the hell will they preform the clinical trials? Well I guess this board member could prove useful now couldn't he since he managed 3.2 billion dollar healthcare hospital setting and probably has many connections... Seasoned Healthcare Executive and Academic Luminary Larry Kaiser, MD, Joins FSD Pharma Board of Directors
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Company Description
FSD Pharma Inc. is a publicly traded holding company since May 2018. FSD Pharma BioSciences, Inc. (a whollyowned subsidiary) is a specialty biotech pharmaceutical research and development (R&D) company focused on developing multiple applications of its lead compound, FSD201 ultramicronized Palmitoyl ethylamine (PEA). Ultramicronized PEA is known to target the cannabinoid2 (CB2) receptors of the endcannabinoid system of the human body and acts by down regulating the proinflammatory cytokines to effectuate an antiinflammatory response. The Company has successfully completed a Phase 1 firstinhuman safety and tolerability study for FSD201, with the compound found to be safe with no serious adverse side effects. This study also validated considerable scientific literature published in the European Union that claims safety and tolerability of microPEA. Ultramicronized PEA is being dispensed in Italy and Spain as a prescription based medical food supplement since 2004. The Company received permission from the Food and Drug Administration (FDA) on June 1, 2020 to submit an Investigational New Drug Application (IND) to use FSD201 to treat COVID19, the disease caused by the SARSCoV2 virus. Severe COVID19 is characterized by an overexuberant inflammatory response that may lead to a cytokine storm and ultimately death. The Company is focused on developing FSD201 for its anti inflammatory properties to avoid the cytokine storm associated with acute lung injury in hospitalized COVID19 patients. FSD’s whollyowned subsidiary, FV Pharma, is a licensed producer under Canada’s Cannabis Act and Regulations, having received its cultivation license on October 13, 2017 and its full Sale for Medical Purposes license on June 21, 2019. The Company is licensed to cultivate cannabis in approximately 25,000 square feet of its facility in Cobourg, Ontario.
Key Points
- FSD is seeking to bring innovative prescription products to market that are formulated from its proprietary microPEA development platform through independent or concomitant use to address multiple disease conditions.
- Having successfully completed a Phase I firstinhuman safety and tolerability trial for FSD201, the Company’s targeted indication for a Phase 2a proof of concept trial is COVID19 (currently engaged with the FDA to get the IND approved). Additional potential targets for Phase 2 trials include newlydiagnosed osteoarthritis of the knee, endometriosis, and opioid replacement and/or sparing agent.
- COVID19 has developed into a worldwide pandemic, with Italy being a particular “hotspot.” The Company contacted the FDA in lateMarch 2020 after becoming aware that several Italian physicians and scientists were advocating for use of ultramicronized PEA for patients suffering from COVID19 symptoms based on the drug’s mechanism of action as a potent and safe antiinflammatory agent that reduces the production of proinflammatory cytokines.
- FSD Pharma holds exclusive worldwide licensing rights (except Italy and Spain) to ultramicronizedPEA for all conditions in all regulatory categories and plans to submit FSD201 Phase 1 trial results for publication in a peerreviewed journal.
- The Company holds a strong IP portfolio covering ultramicronized composition of matter and use (202934 U.S. expiration).
- As of June 30, 2020, the Company held approximately C$52M in cash and noncash assets.
FSD Pharma Inc. 520 William Street
Cobourg, ON K9A 3A5 Canada
Phone: (647) 8647969
https://fsdpharma.com HUGE (NASDAQ) | HUGENASDAQ | | Recent Price (07/10/20) | $3.80 | | 52week Range | $2.39 $32.16 | | Shares Outstanding | 8.1 mm | | Market Capitalization | C$31 mm | | Average 10day volume | 359,277 | | Insider Ownership +>5% | 4% | | Institutional Ownership | 11% | | EPS (Year ended 03/31/20) | C($1.33) | | Employees | 17 | | |
Oneyear Stock Chart See page 10 for applicable disclosures. RECENT DEVELOPMENTS FSD Pharma is progressing in its accomplishments, with a specific focus on advancing ultramicronized PEA (FSD201) into a Phase 2a proofofconcept trial for the treatment of COVID19. A timeline of the key recent events reported this quarter by the Company is summarized below. The base Executive Informational Overview, which was published on March 11, 2020 (
https://bit.ly/31DDcxk) on FSD Pharma, provides a complete Company profile.
- June 22, 2020—FSD Pharma accounted favorable topline results from its Phase 1 randomized, doubleblind, placebocontrolled study of ultramicronized PEA (FSD201). This singlesite study was conducted at the Alfred Hospital, part of the Alfred Health group of hospitals serving the state of Victoria in Australia and enrolled 48 healthy adult men and women. The trial sequentially tested single ascending doses ranging from 600 mg to 2400 mg tablets and multiple ascending doses ranging from 600 mg to 1200 mg tablets administered twice daily for 7 consecutive days. The single ascending dose subjects were also tested for food effect. The study found ultramicronized PEA was safe and well tolerated. Mild and selflimiting side effects were reported and were deemed unlikely to be related to study drug. There were no abnormal laboratory findings or ECGs observed during the study and no serious adverse events reported. No subjects withdrew due to an adverse event and all eligible subjects completed all doses. The pharmacokinetic profile of FSD201 in this study is still being analyzed. The study was led by principal researcher Jason Lickliter, MD, Chief Medical Officer of Nucleus Network, Australia.
The Company plans to submit the FSD201 Phase 1 trial results for publication in a peerreviewed journal and advance this compound into a Phase 2a proofofconcept trial for the treatment of COVID19. Severe COVID19 is characterized by an overexuberant inflammatory response that may lead to a cytokine storm and ultimately death. The U.S. FDA gave the Company permission to submit an Investigational New Drug (IND) application for the use of FSD201 to treat COVID19. FSD Pharma contacted the FDA after it became aware that Italian physicians and scientists were supporting the use of ultramicronized PEA for patients suffering from symptoms of COVID19 based on the drug’s mechanism of action as a potent and safe antiinflammatory agent that reduces the production of proinflammatory cytokines and where it may help mitigate a cytokine storm. The Company has not made any express or implied claims that its product has the ability to eliminate, cure, or contain the COVID19 (or SARS2 Coronavirus).
- June 9, 2020—FSD Pharma announced the closing of a previously announced private placement of 1,500,000 of the Company’s Class B Subordinate Voting Shares at a price of C$6.75 per share and warrants to purchase 1,500,000 Shares of the Company to certain institutional investors for gross proceeds (before placement fees and other estimated offering expenses payable by the Company) of approximately C$10.125 million. The warrants have a fiveyear term and an exercise price of C$9.65 per share. The Company has also granted the placement agents an option to arrange for purchases of up to an additional C$10.125 million of securities on the terms above for a period of 30 days following the initial closing. The net proceeds from this private placement are expected to be used for working capital and other general corporate purposes.
- June 4, 2020—FSD Pharma announced that it has entered into definitive agreements with certain institutional investors for the purchase and sale of 1,500,000 shares of the Company’s Class B Subordinate Voting Shares at a price of C$6.75 per share pursuant to a private placement, resulting in gross proceeds of approximately C$10.125 million. The Company has also agreed to issue common share purchase warrants to purchase 1,500,000 shares of the Company. The warrants will have a five yearterm and an exercise price of C$9.65 per share. The Company has granted the investors an option to acquire up to an additional C$10.125 million of units on the terms set forth above for a period of 30 days following the initial closing.
- June 3, 2020—FSD Pharma announced that the U.S. Food and Drug Administration (FDA) has given the Company permission to submit an IND for the use of FSD201 to treat COVID19, the disease caused by the SARSCoV2 virus. FSD Pharma is focused on developing FSD201 for its antiinflammatory properties to avoid the cytokine storm associated with acute lung injury in hospitalized COVID19 patients. The FDA’s permission to design a proofofconcept study evaluating clinical doses of FSD201 in COVID19 patients is a paradigm shift for FSD Pharma. The Company contacted the FDA in lateMarch 2020 after becoming aware that several Italian physicians and scientists were advocating for use of ultramicronized PEA for patients suffering from symptoms of COVID19, based on the drug’s mechanism of action as a potent and safe antiinflammatory agent that reduces the production of proinflammatory cytokines. Various studies over the past 40 years further validate the efficacy and safety of ultramicronized PEA in treatment and prophylactic effects in respiratory infections. These studies also pointed out that the ease of application of PEA and offers the possibility to have a quick therapeutic answer ready in the event of a flu epidemic.
Greater details on the Company’s COVID19 efforts underway are provided on page 4. - May 21, 2020—FSD Pharma announced the sale of 5 million common shares of Pharmadrug Inc. (BUZZCSE) (formerly Aura Health) in a privately negotiated transaction at C$0.08 per share, for cash proceeds of C$400,000. Under the terms of the sale, the buyer has the option (through June 26, 2020) to purchase an additional 5 million shares of Pharmadrug at C$0.10 per share from FSD Pharma for cash proceeds of C$500,000. FSD Pharma’s equity position of 13.5 million Pharmadrug shares was established in April 2019 as part of a share exchange transaction. The Company may consider the divestiture of the balance of its equity stake in Pharmadrug through open market transactions.
- May 14, 2020—FSD Pharma reported that management’s discussion and analysis of financial condition and results of operations for the three months ended March 31, 2020 have been filed and can be viewed on the Company’s SEDAR profile at www.sedar.com as well as on pages 7, 8, and 9 of this Update. The Company also provided an update on its primary business efforts:
- The Phase 1 firstinhuman safety and tolerability study with FSD201 in Australia is progressing.
- FV Pharma, a licensed producer under Canada’s Cannabis Act and Regulations and a whollyowned subsidiary of the Company, continued to operate at a scaled back level due to the COVID19 pandemic. The facility’s medical cannabis license remains in good standing. It is fulfilling weekly shipments to its existing customers and continues to maintain its genetics library.
- In 1Q20, the Company initiated efforts to strengthen available cash on hand. It realized more than C$7.7 million by liquidating its equity interest in Cannara Biotech (LOVECSE). It has also listed its real estate asset in Cobourg, Ontario for sale and has filed for a mixed shelf registration for up to C$100 million.
- March 23, 2020—FSD Pharma announced that it has taken steps to mitigate the impact of the novel coronavirus SARSCoV2 pandemic on its whollyowned subsidiary, FV Pharma Inc. and its facility in Cobourg, Ontario. The Company’s actions are aligned with evolving guidance from provincial and local Canadian health officials. FSD Pharma management implemented a systematic and orderly scale back of FV Pharma’s cultivation operations and a furlough policy for its workforce, except for certain personnel working staggered shifts to ensure continuity of operations and licensure. The Company has also closed its facility to collaboration partners and ceased their operations.
FSD PHARMA REQUESTS TO INITIATE A HUMAN CLINICAL EFFICACY TRIAL OF ULTRAMICRONIZEDPEA (FSD201) ON EXPLORATORY IND BASIS TO TREAT COVID19 PATIENTS On June 3, 2020, the Company announced that the U.S. FDA had given FSD Pharma permission to submit an Investigational New Drug Application (IND) to use FSD201 to treat COVID19, the disease caused by the SARSCoV2 virus. Severe COVID19 is characterized by an overexuberant inflammatory response that may lead to a cytokine storm and ultimately death. FSD Pharma is focused on developing FSD201 for its antiinflammatory properties to avoid the cytokine storm associated with acute lung injury in hospitalized COVID19 patients.
The FDA’s permission to design a proofofconcept study evaluating clinical doses of FSD201 in COVID19 patients is a paradigm shift for FSD Pharma. The Company contacted the FDA in lateMarch 2020 after becoming aware that several Italian physicians and scientists were advocating for use of ultramicronized PEA for patients suffering from symptoms of COVID19 based on the drug’s mechanism of action as a potent and safe antiinflammatory agent that reduces the production of proinflammatory cytokines. Various studies over the past 40 years further validate the efficacy and safety of ultramicronized PEA in treatment and prophylactic effects in respiratory infections. These studies also pointed out that the ease of application of PEA offers the possibility to have a quick therapeutic ready in the event of a flu epidemic.
Relevance to COVID19 Pandemic COVID19 has developed into a worldwide pandemic, with Italy being a particular “hotspot.” There is a desperate need for new medicines to treat COVID19 patients, as the virus has shut down much of the world. Healthcare providers on the front lines have been employing existing medicines, such as the malaria drugs, hydroxychloroquine and chloroquine. FSD Pharma recently became aware that several Italian physicianscientists are advocating for the use of ultramicronizedPEA for patients suffering from symptoms of COVID19 based on the drug’s mechanism of action as a potent and safe antiinflammatory agent that has been demonstrated to reduce the production of pro inflammatory cytokines.
Over 350 papers have been referenced in PubMed in the last 50 years describing the physiological properties of PEA and its pharmacological and therapeutic profile. PEA has a broad spectrum of biological targets and target molecules, among which are PPARalpha, TRPV1, and orphan receptors such as GPR55.
COVID19 Trial Design Based on FDA feedback received to date, the Company expects the trial to be a randomized, controlled, double blind, U.S. multicenter study to assess the efficacy and safety of FSD201 dosed 600mg or 1200mg twicedaily plus standard of care (SOC) versus SOC alone in symptomatic patients with clinical presentation compatible with COVID
19. Eligible patients will present with symptoms consistent with influenza/coronavirus (fever, dry cough, malaise, difficulty breathing) and/or newly documented positive case of COVID19.
The primary endpoint is to determine if FSD201 plus SOC provides a significant improvement in clinical status (i.e., shorter time to symptom relief). Secondary objectives are to determine if FSD201 plus SOC demonstrates additional benefit in terms of safety, objective assessments, such as length of time to normalization of fever, length of time to improvement of oxygen saturation, and length of time to clinical progression, including time to mechanical ventilation or hospitalization, and length of hospital stay. The exploratory endpoint is cytokine clearance (as measured by Enzyme Linked Immunosorbent Assay [ELISA]). Treatment period is expected to be 14 days. All patients who experience clinical benefit are expected to continue to receive their assigned treatment until study completion.
Justification for Ultramicronized PEA in COVID19 Over 600 scientific papers attest to the physiological properties of PEA and its role as an endogenous modulator, as well as its pharmacological and therapeutic effects, specifically its antiinflammatory profile. PEA acts via multiple mechanisms, either directly to activate PPARα and GPR55 or indirectly through the inhibition of FAAH, which increases endogenous levels of anandamide (AEA) and 2arachidonoylglycerol (2AG). These endocannabinoids directly activate CB2 (or CB1) receptors and TRPV1 channels (entourage effect). PEA may also activate TRPV1 channels via PPARα. AEA has been shown to inhibit tumor necrosis factorαinduced NFkappa B activation, independent of CB1 and CB2. Saturated acylethanolamides, such as PEA (an endogenous congener of AEA), may act in an analogous fashion to modify chronic inflammation in autoimmune disorders.
Nobel laureate Rita LeviMontalcini described the importance of the activation of the inflammatory cascade and in 1993 discovered that PEA functions as a mast cell modulator by reducing mast cell migration and degranulation; thus, PEA reduces the pathological overactivation of these cells and the activity of proinflammatory cytokines (such as TNFα and IL6), cyclooxygenase, and iNOS. It is this excess immune response activity that contributes to the physiologic derangement induced by influenza viruses and sets up the pathogenesis of the “cytokine storm.” Thus, PEA down regulates hyperactive mast cells, inhibits iNOS expression, and nuclear NFkappa B translocation. It is theorized that coronavirus activates the cellular IKK/NFkappa B signaling pathway for replication; therefore, PEA as a PPARα agonist may improve oxidative/nitrosative stress induced by NFkappa B and may be a suitable agent for antiviral intervention. PEA has also repeatedly been shown to downmodulate excess immune response activity that contributes to the physiologic derangement induced by viruses and help mitigate the pathogenesis of the “cytokine storm.”
Between 1969 and 1979, PEA was marketed as Impulsin by a pharmaceutical manufacturer in the former Czechoslovakia to treat influenza and the common cold. During this period, clinical trials were conducted for these indications that involved nearly 4,000 patients and volunteers across six randomized, doubleblind, placebo controlled trials. Together, these clinical trials demonstrated that PEA has clear treatment and prophylactic effects in respiratory infections and was safe. Side effects were not reported, and study authors explicitly stated that “No side effects were registered after several years of clinical testing of Impulsin in military and civilian communities.” They also stated that the ease of application of PEA offers the possibility to have a quick therapeutic answer ready in the event of a flu epidemic.
Background on Ultramicronized PEA FSD Pharma acquired worldwide rights (exItaly and Spain) to ultramicronized PEA from Epitech Group, an Italian pharmaceutical company that invented and holds the patents until 2034 for ultramicronized PEA (defined as 0.6 10µM particle size). PEA is a naturally occurring fatty acid amide that was first discovered in the yolks of chicken eggs. It is biosynthesized from a membrane phospholipid and is degraded to palmitic acid and ethanolamine and serves as an antiinflammatory modulator within the cell. Epitech markets ultramicronized PEA as a prescription based “Food for Special Medical Purposes” in Italy under the brand name Normast® 600mg oral tablets, for several chronic pain and inflammatory conditions, including sciatic pain and diabetic neuropathy. FSD is focused on developing ultramicronizedPEA (FSD201) for its antiinflammatory properties. A firstinhuman safety and tolerability study is currently progressing in Australia led by principal researcher Jason Lickliter, MD, Chief Medical Officer of Nucleus Network.
Numerous clinical trials assessing the safety and efficacy of ultramicronized PEA on chronic pain have been published in the last decade, demonstrating that ultramicronized PEA at doses up to 2700mg/day administered to patients with various chronic pain syndromes induced a significant decrease in pain intensity, compared with control groups. In addition, clinical studies have demonstrated that ultramicronized PEA is generally very well tolerated. More than 1,500 patients have received either ultramicronized or micronized PEA in clinical studies and no serious adverse events were reported in the vast majority of these studies at doses as high as 2700mg/day.
RECENT MILESTONES June 2020 - Successfully completed Phase 1 inhuman safety and tolerability study with no serious adverse effects reported
- Raised C$10.125 million through a private placement in an institutional investor only round
- Received U.S. FDA approval to design a Phase 2a clinical trial to treat COVID19 patients
May 2020 - Monetized noncore asset with sale of partial equity stake in Pharmadrug Inc.
April 2020 - Filed PreIND Meeting Request Package (PIND 149800) with the FDA for the treatment of COVID19 patients
March 2020 - In response to COVID19 pandemic, scaled down operation at Cannabis Production Facility in Canada (FV Pharma)
- Initiated Phase 1 in human safety and tolerability study for microPEA in Australia
- CEO rang Opening Bell on Canadian Securities Exchange (CSE) to celebrate accomplishment as the first CSE listed company to duallist onto a major U.S. stock exchange
- Filed mixed shelf registration for up to C$100 million
POTENTIAL MILESTONES - The Company plans to submit Phase I trial results for FSD201 for publication in a peerreviewed journal and advance this compound into a Phase 2a proofofconcept trial for the treatment of COVID19.
- The U.S. Food and Drug Administration recently gave the Company permission to submit an Investigational New Drug application for the use of FSD201 to treat COVID19.
- FSD contacted the FDA after becoming aware that Italian physicians and scientists were advocating for use of ultramicronized PEA for patients suffering from symptoms of COVID19 based on the drug’s mechanism of action as a potent and safe antiinflammatory agent that reduces the production of proinflammatory cytokines and may help mitigate a cytokine storm.”
RECENT FINANCIAL RESULTS In order to mitigate the impact of COVID19, the Company implemented a systematic and orderly scale back of FV Pharma’s cultivation operations and a furlough policy for its workforce, except for certain personnel working staggered shifts to ensure continuity of operations and licensure, effective March 23, 2020. The Company has also closed its facility to collaboration partners and ceased their operations. These restrictions are expected to stay in place until further guidance is provided by provincial and local Canadian health officials advising it is safe for such restrictions to be removed. The impact of COVID19 did not have a material impact on the financial results for the three months ended March 31, 2020. Pages 710 provide the Company’s most recent Condensed Consolidated Financial Statements for the quarter ended March 31, 2020.
FSD Pharma Inc.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited) (expressed in Canadian dollars, except number of shares)
Three months ended March 31, | | 2020
$ | 2019
$ |
Revenue |
— |
— |
Cost of revenue | — | — |
| Gross loss before fair value adjustments | — | — |
| Fair value adjustments on inventory sold | — | — |
| Unrealized loss (gain) on changes in fair value of biological assets | — | — |
| Gross (loss) profit | — | — |
| Expenses | | |
| General and administrative | 4,008,869 | 2,104,330 |
| Research and development | 403,287 | — |
| Sharebased payments | 3,062,930 | 302,858 |
| Depreciation and amortization | 1,291,148 | — |
| Impairment of rightofuse asset | 119,447 | — |
| Total operating expenses | 8,885,681 | 2,407,188 |
| Loss from continuing operations | (8,885,681) | (2,407,188) |
Other income |
(18,081) | — |
| Finance expense | 97,253 | — |
| Gain on settlement of derivative liability | (843,301) | — |
| Loss (gain) on changes in fair value of other investments | 2,725,061 | (1,240,047) |
| Net loss from continuing operations | (10,846,613) | (1,167,141) |
| Net loss from discontinued operations | (1,597,587) | (1,130,145) |
| Net loss for the period | (12,444,200) | (2,297,286) |
| Other comprehensive income | | |
Items that may be subsequently reclassified to income:
Exchange gain on translation of foreign operations |
1,618,974 |
— |
| Comprehensive loss | (10,825,226) | (2,297,286) |
Net loss per share | | |
| Basic and diluted continuing operations | (1.33) | (0.17) |
| Basic and diluted discontinued operations | (0.20) | (0.16) |
| Weighted average number of shares outstanding – basic and diluted | 8,149,759 | 6,901,558 |
| Source: FSD Pharma Inc. | | |
FSD Pharma Inc.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(unaudited) (expressed in Canadian dollars)
| As at, | March 31,
2020
$ | March 31,
2019
$ |
ASSETS
Current assets
Cash |
8,358,899 |
7,932,737 |
| Trade and other receivables | 1,941,517 | 2,070,055 |
| Prepaid expenses and deposits | 2,728,562 | 430,381 |
| Inventories | — | 942,939 |
| Biological assets | — | — |
| | 13,028,978 | 11,376,112 |
| Assets held for sale | 12,314,080 | — |
| | 25,343,058 | 11,376,112 |
Noncurrent assets
Other investments |
1,312,311 |
11,780,864 |
| Rightofuse asset, net | — | 127,410 |
| Property, plant and equipment, net | — | 11,804,145 |
| Intangible assets, net | 23,069,420 | 22,358,932 |
| | 49,724,789 | 57,447,463 |
LIABILITIES
Current liabilities
Trade and other payables |
4,844,344 |
4,467,826 |
| Lease obligations | 56,831 | 56,207 |
| Derivative liability | — | 2,646,269 |
| Notes payable | 2,084,590 | 1,908,412 |
Noncurrent liabilities | 6,985,765 | 9,078,714 |
| Lease obligations | 135,710 | 146,662 |
| | 7,121,475 | 9,225,376 |
SHAREHOLDER'S EQUITY
Class A share capital |
201,500 |
201,500 |
| Class B share capital | 101,887,365 | 97,815,149 |
| Warrant reserve | 5,626,160 | 5,745,034 |
| Contributed surplus | 24,344,210 | 23,091,099 |
| Foreign exchange translation reserve | 1,506,284 | (112,690) |
| Accumulated deficit | (90,962,205) | (78,518,005) |
| | 42,603,314 | 48,222,087 |
| | 49,724,789 | 57,447,463 |
| Source: FSD Pharma Inc. | | |
FSD Pharma Inc.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
For the three months ended March 31, 2020 and 2019 (unaudited) (expressed in Canadian dollars)
| For the three months ended March 31, | 2020
$ | 2019
$ |
Operating activities
Net loss |
(10,846,613) |
(1,167,141) |
Add (deduct) items not affecting cash
Depreciation and amortization |
1,291,148 |
— |
| Impairment of rightofuse asset | 119,447 | — |
| Interest expense | 97,253 | — |
| Sharebased payments | 3,062,930 | 302,858 |
| Change in fair value of other investments | 2,725,061 | (1,240,047) |
| Change in fair value of derivative liability | (843,301) | — |
Changes in noncash working capital balances
Trade and other receivables |
(596,070) |
165,115 |
| Prepaid expenses and deposits | (2,141,679) | (52,183) |
| Trade and other payables | (27,219) | 32,946 |
| Cash used in continuing operating activities | (7,159,043) | (1,958,452) |
| Cash used in discontinued operating activities | (144,235) | (2,047,436) |
| Cash used in operating activities | (7,303,278) | (4,005,888) |
Investing activities
Proceeds from sale of investments |
7,743,492 |
— |
| Cash provided by continuing investing activities | 7,743,492 | — |
| Cash used in discontinued investing activities | — | (482,430) |
| Cash provided by (used in) investing activities | 7,743,492 | (482,430) |
Financing activities
Repayment of lease obligation |
(14,052) |
— |
| Proceeds from exercise of stock options | — | 459,199 |
| Cash (used in) provided by continuing financing activities | (14,052) | 459,199 |
| Cash (used in) provided by discontinued financing activities | — | — |
| Cash (used in) provided by financing activities | (14,052) | 459,199 |
Net increase (decrease) in cash during the period |
426,162 |
(4,029,119) |
Cash, beginning of period |
7,932,737 |
21,134,930 |
| Cash, end of period | 8,358,899 | 17,105,811 |
Source: FSD Pharma Inc. | | |
This Quarterly Update has been prepared by FSD Pharma Inc. (“FSD” or “the Company”) with the assistance of Crystal Research Associates, LLC (“CRA”) based upon information provided by the Company. CRA has not independently verified such information. Some of the information in this Update relates to future events or future business and financial performance. Such statements constitute forwardlooking information within the meaning of the Private Securities Litigation Act of 1995. Such statements can only be predictions and the actual events or results may differ from those discussed due to the risks described in FSD’s statements on its financial and other reports filed from time to time.
The content of this report with respect to FSD has been compiled primarily from information available to the public released by the Company through news releases, presentations, Annual Reports, and other filings. FSD is solely responsible for the accuracy of this information. Information as to other companies has been prepared from publicly available information and has not been independently verified by FSD or CRA. Certain summaries of activities and outcomes have been condensed to aid the reader in gaining a general understanding. CRA assumes no responsibility to update the information contained in this report. In addition, CRA has been compensated by the Company in cash of forty thousand U.S. dollars for its services in creating the base Executive Informational Overview (EIO) report and for Quarterly Updates.
Investors should carefully consider the risks and information about FSD’s business. Investors should not interpret the order in which considerations are presented in this or other filings as an indication of their relative importance. In addition, the risks and uncertainties overviewed herein are not the only risks that the Company faces. Additional risks and uncertainties not presently known to FSD or that it currently believes to be immaterial may also adversely affect the Company’s business. If any of such risks and uncertainties develops into an actual event, FSD’s business, financial condition, and results of operations could be materially and adversely affected, and the trading price of the Company’s shares could decline.