Lexaria Bioscience Corp.’s (NASDAQ: LEXX) Drug Development Program and Recent FDA Confirmation Position It for Favorable Valuation

 

• Lexaria is a global innovator of drug delivery platforms, including its patented DehydraTECH(TM) technology
• The company recently released information that would help its stakeholders research and understand how biotech and pharmaceutical companies are valued
• Based on some of the methodologies used in valuation, Lexaria is positioned favorably as its DehydraTECH-processed CBD for the treatment of hypertension has successfully reached the IND application stage, with the program recently receiving an additional boost
• The FDA agreed with Lexaria’s proposal to pursue a 505(b)(2) new drug application (“NDA”) regulatory pathway, an abbreviated pathway, for its hypertension program

As a follow-up to recent coverage by Zacks Small-Cap Research, which valued the company at $15.00 (https://nnw.fm/4kNBc), global innovator Lexaria Bioscience (NASDAQ: LEXX) provided information to its stakeholders that would help them conveniently research and understand different non-affiliated third-party sources and their methodologies for valuing biotech and pharmaceutical companies.

“Valuation of equities is a complex task with innumerable risks and rewards that include far-reaching macro events as well as company-specific developments. It is nearly impossible to foresee all risks and rewards, but underlying logic-based evaluation is one way to provide a realistic framework of expectations that investors can use in their analysis,” the August 11 press release reads (https://nnw.fm/t27DQ).

One of the logic-based evaluations considers the stage at which a company’s drug development program has reached. According to the U.S. Food and Drug Administration (“FDA”), there are five steps to the drug development process: Discovery and Development, Preclinical Research, Clinical Research, FDA Drug Review, and, finally, FDA Post-Market Drug Safety Monitoring. However, not more than about 250 of 5,000-10,000 compounds tested during the Discovery stage successfully transition to the third step. Against this backdrop, Lexaria stands out, having completed the first two steps with its DehydraTECH-CBD for hypertension treatment, with favorable results to boot.

The company’s first advanced human clinical study (“HCS”) for hypertension, conducted in 2018, for example, showed that DehydraTECH drug delivery technology delivered 317% more CBD to the blood at 30 minutes. Later HCS’s evidenced rapid and sustained drop in blood pressure (HYPER-H21-1), up to a 23% average reduction in overnight blood pressure and reduced arterial stiffness (HYPER-H21-2), and a 41% overall reduction in pulmonary artery systolic pressure (“PASP”) in male subjects (HYPER-H21-3). Lexaria is set to announce results from its fourth HCS – HYPER-H21-4 – in Q4 2022 (https://nnw.fm/vEweN). 

If the HYPER-H21-4 study were registered with the FDA, Lexaria notes, it would possibly be a Phase 1B or 2A study. This information lends color to the company’s valuation going by a guide prepared by Bay Bridge Bio, which notes that a company’s valuation increases as its drug development progresses from Phase 1 through Phase 3. For example, at the start of a Phase I trial, a biotech company’s valuation would be $88 million, a figure that would then rise to $248 million at the start of Phase 2 study, finally eclipsing the $1 billion mark to settle at $1.119 billion when the Phase III trial begins. The figures increase further following an FDA approval of the drug candidate.

Considering the FDA’s recent confirmation that it agreed with Lexaria’s proposal to pursue a 505(b)(2) new drug application (“NDA”) regulatory pathway, an abbreviated pathway, the company’s accelerated drug development program for hypertension therapeutics could wend way to a multi-billion-dollar valuation in due course. The pharmaceutical industry is rife with examples of such possibilities.

In March, for example, Pfizer Inc. (NYSE: PFE) completed the acquisition of clinical-stage company Arena Pharmaceuticals for a total consideration of $6.7 billion. At the time of the acquisition, Arena was expecting results for its Phase 3 trial undertaken to evaluate the safety and efficacy of the etrasimod drug candidate in patients with active ulcerative colitis (https://nnw.fm/DxgbZ). 

As a December 2021 report by accounting firm PwC notes, big pharma is set to spend anywhere between $5 billion and $15 billion and, in some cases, as much as $50 billion in 2022 to purchase promising biotech companies and their IP, as they seek to bring on board in new drugs that can become serious revenue generators (https://nnw.fm/ogdk2). Such acquisitions attest that biotech companies with little to no revenue can still be worth billions.

For more information, visit the company’s website at www.LexariaBioscience.com.

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://nnw.fm/LEXX

About NetworkNewsWire

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Laredo Oil Inc. (LRDC) Progressing Toward Drilling as 2023 Oil Demand Projected to Increase

 

• OPEC releases “bullish” forecast for oil demand moving into 2023
• Healthy global economic growth, improvements in geopolitical developments and containment of COVID-19 in China contribute to positive projection
• LRDC has leased 37,900 mineral acres in the Western Williston Basin of Montana

Despite a slowing economy and worries of a recession, the oil and gas industry has rebounded strongly throughout 2021, with oil prices reaching their highest levels in six years, a recent Deloitte report noted (https://nnw.fm/Gsu5J); OPEC’s recent bullish 2023 forecast indicates that upward trend may continue. That’s good news for Laredo Oil (OTC: LRDC), an oil exploration and production company that is working to start drilling in Montana.

“OPEC expects global oil demand to rise in 2023 but at a slower pace than 2022, the producer group said in its first forecast for next year, citing still robust economic growth and progress in containing COVID-19 in China,” reported Reuters (https://nnw.fm/BQMQ1). “In a monthly report on Tuesday, the Organization of the Petroleum Exporting Countries (‘OPEC’) said it expects demand to rise by 2.7 million barrels per day (‘bpd’), or 2.7%, in 2023. It left this year’s growth forecast unchanged at 3.36 million bpd.”

Reuters noted that oil use has “rebounded from the pandemic-induced slump in 2020 and is set to exceed 2019 levels this year. The outlook for 2023 suggests a strain on supplies could persist as growth in non-OPEC output, which has been hit by Russian losses, is expected to lag the rise in demand.” However, Reuters noted that OPEC pointed to “2023 expectations for healthy global economic growth amidst improvements in geopolitical developments, combined with expected improvements in the containment of COVID-19 in China” as factors in its projected positive oil forecast. 

Laredo Oil’s primary focus is on acquiring, developing and operating undervalued conventional oil and gas properties. The company is also engaged in the acquisition and development of select mature oil fields that are suitable for its proprietary Enhanced Oil Recovery (“EOR”) methods.

The company leased 37,900 mineral acres in the Western Williston Basin of Montana at favorable prices during the most recent down cycle and continues to take leases in the area. 

For more information, visit the company’s website at www.Laredo-Oil.com.

NOTE TO INVESTORS: The latest news and updates relating to LRDC are available in the company’s newsroom at https://nnw.fm/LRDC

About NetworkNewsWire

NetworkNewsWire (“NNW”) is a financial news and content distribution company, one of 50+ brands within the InvestorBrandNetwork (“IBN”), that provides: (1) access to a network of wire solutions via InvestorWire to reach all target markets, industries and demographics in the most effective manner possible; (2) article and editorial syndication to 5,000+ news outlets; (3) enhanced press release solutions to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of corporate communications solutions. As a multifaceted organization with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience comprising investors, consumers, journalists and the general public. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.

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Cybin Inc. (NEO: CYBN) (NYSE American: CYBN) Leading Out in Transformation of Psychedelic Sector

 

• Psilocybin is seeing a “research resurgence” focused on how the substance changes the brain’s connectivity patterns
• CYBN is leading the industry in developing proprietary psychedelic-based therapeutics
• The company’s lead investigational molecule has the potential to treat major depressive disorder and alcohol use disorder

The status of psilocybin is evolving as a result of mounting public acceptance and growing evidence that the substance delivers remarkable health benefits. Cybin (NEO: CYBN) (NYSE American: CYBN) is on the leading edge of this transformation, as the clinical-stage biopharmaceutical company focuses on progressing psychedelics to therapeutics by offering a new standard of care for mental-health disorders and improving patient outcomes.

Psilocybin is undergoing a transformation. Numerous studies have reported positive findings using psilocybin “for treating depression as well as smoking and alcohol addiction, and for reducing anxiety in the terminally ill,” reported Scientific America (https://nnw.fm/FfpDi). “Ongoing and planned studies are testing the drug for conditions that include opioid dependence, PTSD and anorexia nervosa. This scientific interest, plus growing social acceptance, is contributing to legal changes in cities across the U.S.”

The article provided a quick overview of the history of the substance, noting that “after a flurry of research in the 1950s and 1960s, psilocybin and all other psychedelics were abruptly banned, partly in response to their embrace by the counterculture. Following the 1971 United Nations Convention on Psychotropic Substances, psilocybin was classed in the U.S. as a Schedule I substance.

The article quoted David Nutt, a neuropsychopharmacologist at Imperial College London, as saying: “It’s the worst censorship of research in history.”

This “censorship” appears to be coming to an end as Nutt and others are leading a “research resurgence” focused on how psilocybin changes the brain’s connectivity patterns, including reducing connections within the usual networks while increasing links between less connected regions. “Just this year, a study showed that treatment involving psilocybin led to sustained network alterations, which seemed to correlate with reduced depression symptoms,” the article observed. “Two organizations are beginning final rounds of trials for psilocybin’s use for depression, which could lead to the substance’s first approval by the U.S. Food and Drug Administration.”

Cybin is heavily involved in this resurgence of research. The company is leading the industry in developing proprietary psychedelic-based therapeutics, with a pipeline featuring three psychedelic molecules —CYB003, CYB004 and CYB005 — that are derived from CYBN’s novel drug-discovery platform (https://nnw.fm/KMEUj). 

Cybin’s lead investigational molecule, CYB003, is a deuterated psilocybin analog derived from psilocybin, which is part of a family of molecules called indolamines that includes more common neurotransmitters, such as serotonin. The substance is designed to achieve less variability in plasma levels, faster onset of action, shorter duration of effect and potentially better tolerability for an overall better outcome for patients. CYB003 has the potential to effectively treat major depressive disorder (“MDD”) and alcohol use disorder (“AUD”) and is currently being evaluated in a phase 1/2a clinical trial.

A deuterated dimethyltryptamine (“DMT”), CYB004 has been shown to exert its psychedelic effects by activating the 5-HT2A receptor. In its natural form, DMT is rapidly metabolized in the body, unstable and not orally bioavailable. However, preclinical studies indicate that the deuterated DMT can overcome these limitations and provide increased oral and pulmonary bioavailability, faster onset with lower doses, less patient variability, and better dose titration for fewer side effects and longer-acting desensitization of the serotonergic receptors. The company reports that CYB004, which is currently in a phase 1 in-human study, has the potential to effectively treat anxiety disorders.

The company’s third substance is CYB005, which is a discovery-phase phenethylamine derivative with the potential to effectively treat neuroinflammation and psychiatric conditions. CYB005 is in preclinical development.

For more information, visit the company’s website at www.Cybin.com.

NOTE TO INVESTORS: The latest news and updates relating to CYBN are available in the company’s newsroom at https://nnw.fm/CYBN

About NetworkNewsWire

NetworkNewsWire (“NNW”) is a financial news and content distribution company, one of 50+ brands within the InvestorBrandNetwork (“IBN”), that provides: (1) access to a network of wire solutions via InvestorWire to reach all target markets, industries and demographics in the most effective manner possible; (2) article and editorial syndication to 5,000+ news outlets; (3) enhanced press release solutions to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of corporate communications solutions. As a multifaceted organization with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience comprising investors, consumers, journalists and the general public. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.

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Golden Matrix Group Inc. (NASDAQ: GMGI) Scores Big Q3 Win on International Expansion

 

• GMGI sets new bar for quarterly revenue, topping $9 million for first time
• The company currently has a string of 15 consecutive profitable quarters
• Golden Matrix is growing through international M&A activity and launching gaming products, including a new highly anticipated eSports platform

Tech stocks have rallied since the tech-laden Nasdaq hit a nearly two-year low in June. Most of the first half of the year was dominated by geopolitical drama, and international upheaval fueling recession concerns amid spiking inflation. None of that stopped Golden Matrix Group (NASDAQ: GMGI) from having its best revenue quarter ever, spearheaded by horizontal and vertical growth.

Golden Matrix, a provider of turnkey and white label gaming platforms and content, hasn’t filed its 10-Q quarterly report with the Securities and Exchange Commission yet, but did provide some color to investors on its third quarter of fiscal 2022, which ran from May-July. The Las Vegas-based company logged record revenues exceeding $9 million in the quarter, an improvement of approximately 177% from $3.25 million in the comparable quarter of fiscal 2021.

Meaningful progress in both its flagship business-to-business (“B2B”) division and new business-to-consumer (“B2C”) division undergirded the jump in revenue. GMGI CEO Brian Goodman called the record quarter “even more impressive when considering the impact of global economic headwinds and an unfavorable exchange rate throughout the quarter.”

The strength of the U.S. dollar is important to Golden Matrix as the bulk of its customers are overseas, particularly Asia-Pacific as far as B2B clients. Golden Matrix has chosen not to foray into the byzantine U.S. market, with its software designed to decline requests coming from within the country to maintain strict compliance with U.S. law. At the end of the quarter, GMGI had about 635 operators and approximately 6.5 million registered users across all its traditional B2B gaming platforms.

Internationally, GMGI’s GM-X System is the industry standard as a configurable and scalable gaming platform providing access to over 10,000 games from dozens of providers along with sophisticated analytics, retention tools, loyalty features, and more. Through GM-X, Golden Matrix offers an array of games, including slots, table games, live games, and sports. The company is also planning on expanding into the burgeoning eSports that is growing at a stunning 22% compound annual growth rate on its way to an estimated $12.5 billion by 2030. The new GMGI B2B eSports platform is expected to make its debut any time now.

Record quarterly revenue has also been spurred on by Golden Matrix taking an 80 percent stake in RKings, the United Kingdom-based owner of a popular skill tournament platform operated in the U.K. and Ireland. RKings gives players an opportunity to win a bevy of products from jewelry to golf clubs to exotic cars and vacations. In the latest quarter, RKings’ B2C competitions engaged more than 46,000 new registered users.

The company didn’t provide insight into EBITDA or net income in its recent news release, but investors surely will be looking forward to the regulatory filings to see if the string of profitable quarters – currently standing at 15 – continues.

For more information, visit the company’s website at www.GoldenMatrix.com. 

NOTE TO INVESTORS: The latest news and updates relating to GMGI are available in the company’s newsroom at https://nnw.fm/GMGI

About NetworkNewsWire

NetworkNewsWire (“NNW”) is a financial news and content distribution company, one of 50+ brands within the InvestorBrandNetwork (“IBN”), that provides: (1) access to a network of wire solutions via InvestorWire to reach all target markets, industries and demographics in the most effective manner possible; (2) article and editorial syndication to 5,000+ news outlets; (3) enhanced press release solutions to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of corporate communications solutions. As a multifaceted organization with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience comprising investors, consumers, journalists and the general public. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.

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Phase I Trial Advance for Concussion Drug Leads Odyssey Health, Inc. (ODYY) to Prepare to Launch the Efficacy Analysis Stage for its Product

 

• Brain concussion injuries have commanded a new level of respect in recent years as military personnel, athletes and care center administrations seek remedies rather than simply encouraging people to “shake off” a hard hit to the head
• Odyssey Health is advancing clinical trials for its novel PRV-002 drug / device solution for treating concussion patients
• The company reported completion of four cohorts of testing for safety in human subjects in August, and is preparing to launch Phase II testing that will evaluate the product’s efficacy
• PRV-002 is administered intranasally where it can be taken up across the blood-brain barrier by the body, helping it to target the area where it is needed most with minimal expression in the blood’s circulation system

Medical solutions innovator Odyssey Health (OTC: ODYY) is preparing to launch Phase II clinical trial testing of its novel brain concussion therapy following successful outcomes in examining its drug’s safety.

Odyssey’s PRV-002 combines a synthetic neurosteroid with an intranasal applicator device to deliver the drug in such a way that it will be taken up into the brain with minimal circulation through the blood system. The drug is lipophilic, which helps it to cross the blood-brain barrier where it needs to go to rapidly eliminate swelling and oxidative stress in the brain in order to maintain proper blood flow to critical parts of the organ.

Odyssey Health has completed a series of lab animal tests involving the company’s proprietary solution and announced this month the successful completion of the first cohort of the multiple ascending dose portion of its Phase I clinical trial analyzing safety of the drug in human volunteers.

The company is finishing up the final stage of its Phase I trial that involves administering high doses of the drug to human patients. Phase II will take a hard look at the efficacy of the drug product by looking at specific outcome measures. (https://nnw.fm/S0YW0).

Concussions, also known medically as mild traumatic brain injury, or mTBI, have come to be taken more seriously in the general public in recent years, particularly as professional athletes have acknowledged a need to prioritize their recovery from significant head impacts over a desire to remain competitive.

NASCAR driver Kurt Busch became one of the latest to acknowledge head injury concerns when he chose to sit out multiple races until he could be assured he was mentally as well as physically recovered from a qualifying round crash in late July.

“Brain injury recovery doesn’t always take a linear path. I’ve been feeling well in my recovery, but this week I pushed to get my heart rate and body in a race simulation type environment, and it’s clear I’m not ready to be back in the race car,” Busch said when he announced he’d miss a fourth race (https://nnw.fm/merpB). “This was by far the hardest week emotionally because I do feel the progression of recovery, but racing requires an extreme physical and mental effort, and my body is not 100% able to sustain the intense race conditions.”

Odyssey’s PRV-002 solution aims to eventually be approved for on-site administration at incidents where head injuries occur, such as at athletic competitions. Patients would be treated within the first minutes after the injury happens, allowing them to avoid swelling that might lead to long-term consequences.

Currently there is no U.S. Food and Drug Administration (“FDA”)-approved medication for treating concussions, allowing Odyssey Health to state they are pursuing a novel solution to fulfill an unmet need for millions of people worldwide.

The Phase II trial is expected to include military sites that sustain a high rate of concussion.

“We need a treatment to prevent the long-term consequences of concussion as far too many of our Service Members are retiring with TBI disorders that lessen their quality of life,” Major General (Ret.) Jim Linder, the former chief of staff for the U.S. Special Operations Command, stated last month in addressing Odyssey’s testing program (https://nnw.fm/sr1nd).”

For more information, visit the company’s website at www.OdysseyHealthInc.com.

NOTE TO INVESTORS: The latest news and updates relating to ODYY are available in the company’s newsroom at https://nnw.fm/ODYY

About NetworkNewsWire

NetworkNewsWire (“NNW”) is a financial news and content distribution company, one of 50+ brands within the InvestorBrandNetwork (“IBN”), that provides: (1) access to a network of wire solutions via InvestorWire to reach all target markets, industries and demographics in the most effective manner possible; (2) article and editorial syndication to 5,000+ news outlets; (3) enhanced press release solutions to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of corporate communications solutions. As a multifaceted organization with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience comprising investors, consumers, journalists and the general public. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.

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