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Heathcare and Biotech Updates

Massachusetts Biotech Advances Novel Cytokine Therapies

Source: Dr. Robert Driscoll  (11/15/23)

Wedbush sees over 300% upside for Werewolf stock based on early clinical success for its PREDATOR platform and pipeline, according to a WedBush research note.

Cambridge, Massachusetts-based Werewolf Therapeutics Inc. (HOWL:NASDAQ) reported Q3 2023 results and progress for its pipeline of INDUKINE product candidates, noted Wedbush analyst Dr. Robert Driscoll in a November 15 research report.

The analysts have an Outperform rating and US$9 price target on Werewolf Therapeutics.

Early Efficacy Signals Seen for Lead Candidate

According to the analysts, Werewolf’s WTX-124 INDUKINE therapy has shown initial proof-of-concept with a differentiated safety profile compared to standard high-dose IL-2 and evidence of antitumor activity in early studies.

At the 12 mg dose, WTX-124 yielded a partial response in a melanoma patient and disease control in lung cancer patients. The company is now testing an 18 mg dose cohort.

The analysts believe this data validates Werewolf’s novel INDUKINE approach to conditionally activating cytokines within tumors while limiting systemic toxicity.

Advancing Broad Pipeline

Beyond WTX-124, Werewolf is evaluating the second INDUKINE candidate, WTX-330, in dose escalation and plans to share preclinical data on WTX-518 in 2024.

The company is also progressing IL-21 INDUKINE WTX-712 towards the clinic based on encouraging preclinical results.

Significant Upside from Current Levels

Wedbush maintains an Outperform rating on Werewolf Therapeutics and a US$9 price target, seeing over 300% upside for the shares.

The firm’s valuation is based on projected 2031 sales for WTX-124 applied to standard revenue multiples.

In summary, the analysts see Werewolf’s INDUKINE platform and early WTX-124 efficacy as validating the company’s novel approach to cytokine therapies in oncology. With multiple clinical catalysts upcoming, they view the risk/reward as favorable.

 

Important Disclosures:

  1. The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
  2. This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

For additional disclosures, please click here.

Disclosures for Wedbush, Werewolf Therapeutics, November 15, 2023

 

Analyst Certification We, Robert Driscoll, Ritika Das and Sam Ravina, certify that the views expressed in this report accurately reflect our personal opinions and that we have not and will not, directly or indirectly, receive compensation or other payments in connection with our specific recommendations or views contained in this report.

Company Specific Disclosures This information is subject to change at any time. 1. WS makes a market in the securities of Werewolf Therapeutics.

OTHER DISCLOSURES The information herein is based on sources that we consider reliable, but its accuracy is not guaranteed. The information contained herein is not a representation by this corporation, nor is any recommendation made herein based on any privileged information. This information is not intended to be nor should it be relied upon as a complete record or analysis: neither is it an offer nor a solicitation of an offer to sell or buy any security mentioned herein. This firm, Wedbush Securities, its officers, employees, and members of their families, or any one or more of them, and its discretionary and advisory accounts, may have a position in any security discussed herein or in related securities and may make, from time to time, purchases or sales thereof in the open market or otherwise. The information and expressions of opinion contained herein are subject to change without further notice. The herein mentioned securities may be sold to or bought from customers on a principal basis by this firm. Additional information with respect to the information contained herein may be obtained upon request. Wedbush Securities does and seeks to do business with companies covered in its research reports. Thus, investors should be aware that the firm may have a conflict of interest that could affect the objectivity of this report. Investors should consider this report as only a single factor in making their investment decision. Please see pages 3–7 of this report for analyst certification and important disclosure information. Retail Investors The information provided is for general informational purposes only and should not be considered an individual recommendation or personalized investment advice. The companies/investments mentioned may not be suitable for everyone. Each investor needs to review their own respective situation(s) before making any investment decisions. All expressions of opinion are subject to change without notice due to shifting market(s), economic or political conditions. Investment involves risks including the risk of principal. Past performance is no guarantee of future results and the opinions presented cannot be viewed as an indicator of future performance.

Telehealth Co. Signs Largest Client Yet

Source: Streetwise Reports  (3/30/23)

Onboarding will begin in April for the health care system that has more than 1,200 care centers in seven states.

Telemedicine company Reliq Health Technologies Inc. (RHT:TSX.V; RQHTF:OTCQB; A2AJTB:WKN) announced it has signed a contract with its largest client yet, a healthcare system with more than 1,200 care centers in seven states.

Onboarding will begin in April at 20 of their skilled nursing facilities, which are expected to add more than 2,000 new patients per month to Reliq’s iUGO platform by the end of the year at an average revenue of US$65 per patient per month.

Skilled nursing facilities are “a very big space for us,” Chief Executive Lisa Crossley said.

Over the last six months, the company has signed three large networks of such facilities, including the newest client.

“That market segment has become incredibly important to us over a very short period of time,” Crossley said. “I think it really speaks to the value proposition we offer to that market segment that we’ve gotten such strong traction in such a short period of time.”

The U.S. skilled nursing facility and rehabilitation market is expected to grow at a compound annual growth rate of 4.5% to US$308.8 billion by 2023, according to a report by Markets and Research.

The U.S. skilled nursing facility and rehabilitation market is expected to grow at a compound annual growth rate of 4.5% to US$308.8 billion by 2023, according to a report by Markets and Research.

“The growing incidences of chronic conditions such as diabetes, paralysis, hypertension, etc., and the rising geriatric population is expected to fuel the market over the next few years,” the report said. “Medicare and Medicaid availability and the growing technologies will play a driving role for the market in the coming years.”

The global telehealth market Reliq serves is anticipated to reach US$380 billion by 2023, according to another Research and Markets report.

The pandemic “led to increased awareness about telemedicine solutions, propelled the adoption rates among patients and providers, and increased the investment activities in the market,” the report said.

Technical analyst Clive Maund of CliveMaund.com recommended the stock shortly after news broke last year that the company’s cash intake went up 485% from the fiscal year 2021 to the fiscal year 2022.

“We, therefore, stay long,” Maund wrote for Streetwise Reports.

The Catalyst: ‘A Very Large Opportunity’

The new client network, which was not identified, has more than 10 million patient encounters per year in New York, Ohio, Maryland, Virginia, Florida, Kentucky, and South Carolina, Reliq said.

Newly discharged patients will get long-term virtual care at home using Reliq’s Transitional Care Management, Remote Patient Monitoring, and Chronic Care Management, and Behavioral Health Integration modules on its platform.

Those patients will bring in an average revenue of US$60 per patient for their first 30 days after discharge and US$65 per patient per month after that.

Technical analyst Clive Maund of CliveMaund.com recommended the stock shortly after news broke last year that the company’s cash intake went up 485% from the fiscal year 2021 to the fiscal year 2022. “We, therefore, stay long,” Maund wrote for Streetwise Reports.

The new client manages a wide variety of care settings, such as primary care clinics, hospice agencies, home health agencies, and hospitals.

“It’s a very large opportunity for us,” Crossley said. “This client is really representative of that very comprehensive, holistic offering that our product and platform represents, and (have) very broad appeal in the market.”

The company also recently announced it had signed 40 new skilled nursing facility clients in California, Florida, and Pennsylvania, adding more than 4,000 new patients per month to iUGO.

This week, it announced it had signed ten new contracts with eight physician practices in Nevada and California and two home health agencies in Texas.

Crossley has said the company services more than 100,000 on iUGO and expects to have as many as 200,000 patients on the platform by the middle of 2023.

Managing Patients at Home

Diseases the company aims to manage at home with iUGO include chronic obstructive pulmonary disease (COPD), congestive heart failure, diabetes, hypertension, and others. Patients get audible reminders to step on a scale, take their blood pressure, or prick their fingers for glucose monitoring. The information is automatically uploaded to the cloud.

iUGO draws on data from fall detection devices, medication tracking, and vitals data to flag patients at home or in facilities who need additional monitoring. It even uses artificial intelligence algorithms in its software.

Reliq is on the cutting edge there, as AI has yet to be widely deployed in health care. But a recent report from McKinsey & Co. and Harvard researchers said that AI adoption could result in savings of 5% to 10% of health care spending, or US$200 billion to US$360 billion annually.

Retail: 91.7%
Management & Insiders: 8%
Institutions: 0.3%
Strategic Investors: 0%
91.7%
8.0%
*Share Structure as of 3/30/2023

 

“For hospitals, the savings come largely from use cases that improve clinical operations . . .  and quality and safety,” the report’s authors wrote. “For physician groups, the savings also mostly come from use cases that improve clinical operations.”

Ownership and Share Structure

About 8% of Reliq’s shares are owned by insiders, including Crossley, with 1.61% or 3.22 million shares. About 0.3% of the company is owned by institutional investors, including FNB Wealth Management, with 0.02% or 0.03 million shares, according to Reuters.

Other top investors include Eugene Beukman, who owns 0.11% or 0.23 million shares, and Brian Storseth, who owns 0.07% or 0.14 million shares, Reuters said.

Crossley said 91.7% of the company is retail.

The company has 200.6 million shares outstanding, with about 197 million free-floating. It has a market cap of CA$97.4 million and trades in a 52-week range of CA$0.92 and CA$0.36.

 

Disclosures:
1) Steve Sobek wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.

2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: Reliq Health Technologies Inc. Click here for important disclosures about sponsor fees.

3) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.

4) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

5) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Eli Lilly is cutting insulin prices and capping copays at $35 – 5 questions answered

By Dana Goldman, University of Southern California and Karen Van Nuys, University of Southern California 

Pharmaceutical giant Eli Lilly is slashing the list prices for some of its most popular insulin products by 70% and capping insulin copays at US$35 for uninsured patients and those with private health insurance. These changes follow efforts by the federal government, the California state government, nonprofits and some companies to make insulin more affordable for the more than 7 million Americans with diabetes who require it.

The Conversation asked Dana Goldman and Karen Van Nuys, two scholars who have researched insulin pricing, to explain why Eli Lilly is dramatically cutting the cost of some of its insulin products and to sum up how it may improve access to this essential medical treatment.

1. Why is Lilly reducing prices now?

High insulin prices have not earned any U.S. manufacturer many friends, with list prices increasing 54% from 2014 to 2019.

Most troublingly, an estimated 1.3 million uninsured people with diabetes and patients with inadequate insurance have resorted to rationing their insulin. Skipping doses because of high insulin prices has sometimes had tragic and even deadly consequences.

But growing competition has shaken up the insulin market in recent years.

For example, Walmart introduced its own private-brand insulin in 2021. Mylan, a large generic drugmaker, developed a version of long-acting insulin called Semglee, priced 65% lower than its branded competitor. But few consumers use those products.

Efforts to produce cheaper insulin by the nonprofit drugmaker CivicaRx and the state of California are several years out and won’t provide immediate relief.

Then there’s the Inflation Reduction Act, a big spending package Congress approved in 2022. It capped insulin out-of-pocket costs at $35 for Americans with Medicare, a government health insurance program that covers people over 65.

And, in fact, Lilly itself has been trying to disrupt insulin prices. In 2019, the drugmaker introduced insulin lispro, a lower-cost version of its blockbuster insulin, Humalog.

2. What does this mean for Americans who need insulin?

Part of the problem with the existing system is that some patients, especially if they’re uninsured or have high deductibles, end up paying the list price – which can mean spending $1,000 or more a month on insulin. This can be a crushing financial burden.

Lilly’s new $35 out-of-pocket cap means that privately insured patients and those without insurance requiring insulin will spend no more than that monthly for copays. Its 70% reduction in the list price of two popular name brand insulins, Humalog and Humulin, will bring some financial relief. And the company has also reduced its generic lispro’s list price to $25 a vial, down from $126.

The evidence is clear that these price reductions will improve patient adherence – which means fewer missed doses of this lifesaving medication.

3. How might Lilly’s actions affect the whole industry?

Lilly has put pressure on its biggest competitors, Novo Nordisk and Sanofi, to follow suit.

These lower prices could also make Lilly’s insulins affordable to cash-paying patients. As a result, these insulins could be added to the list of drugs provided by pharmacies that are disrupting the U.S. prescription drug industry, like Mark Cuban’s Cost Plus Drug Co. and Blueberry Pharmacy. These companies provide low-cost drugs with transparent markups or through membership programs, typically without insurance.

4. Why did insulin get so expensive in the US?

That lispro, Lilly’s own, cheaper authorized generic insulin, hasn’t completely displaced the equivalent name brand Humalog in the market by now may seem surprising. But it is the result of the complex U.S. prescription drug distribution system.

Insulin prices are the result of a complex set of negotiations between manufacturers and pharmacy benefit managers, which act on behalf of insurers. The three largest – CVS Caremark, Express Scripts and Optum Rx – handle about 80% of all prescriptions.

These middlemen negotiate directly with Lilly and other insulin manufacturers, focusing on two key sums: the list price and the rebate. Manufacturers are paid the list price but then must pay a rebate to the pharmacy benefit managers.

How do pharmacy benefit managers get manufacturers to pay rebates? They maintain formularies – lists of drugs that patients in a health plan can access. If an insulin manufacturer wants to supply diabetes patients, it needs to remain on those formularies. And doing so requires the manufacturer to pay bigger rebates. Otherwise, pharmacy benefit managers can exclude the manufacturer.

In 2016, OptumRx, which negotiates insulin prices for about 28 million people, excluded only four types of insulin from its formulary. By 2022, OptumRx was excluding 13 insulins.

Keeping insulin on formularies, in short, has required high rebates, and list prices have increased along with them. Ironically, as insulin list prices have been rising, manufacturers have been making less money off of insulin sales, while middlemen have been making more. The key to true price competition is to ensure access to all versions of insulin and to convince patients and providers that people with diabetes can substitute lower-cost versions without compromising their health.

5. What might happen next?

The Federal Trade Commission, a government agency that probes anti-competitive practices, and Congress are now investigating pharmacy benefit managers’ rebate and formulary practices, among other things. These investigations, along with Lilly’s moves, may lead other insulin manufacturers to lower their list prices.

And once its competitors decide whether they will follow Lilly’s example, pharmacy benefit managers will be under a lot of scrutiny to see whether they give preferred formulary placement to the lowest-cost insulin products, or to those that pay the highest rebates.The Conversation

About the Authors:

Dana Goldman, Dean of the Sol Price School of Public Policy; Professor of Pharmacy, Public Policy, and Economics, University of Southern California and Karen Van Nuys, Executive Director of the Value of Life Sciences Innovation program; Fellow at the USC Schaeffer Center, University of Southern California

This article is republished from The Conversation under a Creative Commons license. Read the original article.

 

Exploring Why The Economist Named this Biotech ‘One To watch’ in 2023

Source: Streetwise Reports  (1/23/23)

As more researchers delve into the medicinal potentials of once-verboten compounds, forward-thinking companies like Awakn Life Sciences Corp. are leading the charge to map their most useful aspects and open access for people who need help now. Read more to learn what catalysts Awakn has in store and why The Economist touched on this treatment as one of their top stories of 2023.

Addiction is a serious problem and one for which drugs are often largely to blame. However, drugs — which is to say, the right drugs, used in the right ways — can also play a large part in the solution.

Few companies are more convinced of the inevitability of this approach to treatment than Awakn Life Sciences Corp. (AWKN:NEO; AWKNF:OTCQB). Founded with the goal of bringing surcease of suffering to the 285 million people who struggle with alcohol addiction each year, the company is at the forefront of addressing this US$25B market.

Awakn was founded in 2020 by a team of experienced researchers and industry professionals who saw a need for more effective, personalized treatments for addiction and mental health disorders.

Awakn’s Treatment is Unique

Many current treatments, such as 12-step programs and other group counseling, are not tailored to the unique needs and characteristics of individual patients, making it difficult for them to achieve long-term recovery.

Currently, three medications are approved by the U.S. Food and Drug Administration to treat alcohol use disorder: acamprosate, disulfiram, and naltrexone. However, studies have found that most people attempting traditional therapies require between two and five attempts to actually shake their addiction.

The Economist touched on Awakn’s current clinics in a recent video, marking it as one of the five stories to watch out for in 2023. In it, Natasha Loder, the health policy editor for The Economist, said, “2023 is going to be a really pivotal year for psychedelic medicines.”

In addition, many existing treatments have not been thoroughly tested and validated through clinical research, leaving doubt about their effectiveness. Awakn has staked its reputation on developing trial-verified therapies that incorporate scheduled substances like the drug ketamine, which is a licensed medicine with well-established safety and efficacy as an analgesic and anesthetic.

In addition to its research and development efforts on the clinical side, Awakn is working to improve access to addiction and mental health care. The company is partnering with healthcare providers, payers, and other stakeholders to develop and implement innovative models of care that are more accessible and affordable for patients.

While the company has made large strides in deploying these methods in its own clinics, it is also bundling its technologies and techniques for licensed distribution to other providers.

The Economist touched on Awakn’s current clinics in a recent video, marking it as one of the five stories to watch out for in 2023. In it, Natasha Loder, the health policy editor for The Economist, said, “2023 is going to be a really pivotal year for psychedelic medicines.”

The Catalyst: Clinic Expansions and a Subsidized Phase III Trial

The past month has been quite busy for Awakn, with the expansion of its Oslo clinic and the announcement of a second Norwegian clinic in Trondheim. The company also announced that its ‘Ketamine for Reduction of Alcohol Relapse’ (KARE) trial has reached Phase III with the assistance of the UK’s National Health System (NHS) and will take place at seven sites across the Kingdom, where Awakn already operates two clinics in London and Bristol.

“More than two million UK adults have serious alcohol problems, yet only one in five get treatment. Unfortunately, three out of four people who quit alcohol will be back drinking heavily after a year,” explains Professor Celia Morgan from the University of Exeter. According to the latest report from Polaris Market Research, the global addiction treatment market was valued at US$8.28 billion in 2021 and is expected to grow at a CAGR of 6.4% during the forecast period.

“If this trial definitively establishes that ketamine and therapy works, we hope we can begin to see it used in NHS settings,” Morgan explains. It should be noted that the NHS spends over £3.5 billion per year treating alcohol addiction.

Awakn’s CEO Anthony Tennyson concurs: “With three Awakn clinics already open in the UK and more in Europe, we are already seeing the benefits of this treatment for our clients on an off-label basis.”

STIFEL GMP analyst Andrew Partheniou recently rated the company a speculative Buy on news of Awakn’s Phase III trial, stating in a report that “government funding for 66% of the total trial cost” is “significantly reducing AWKN’s out-of-pocket expense to just over US$1 million.”

“Awakn therapeutics for treating addiction have been proven to be highly efficacious. In our Phase II trial of AUD sufferers, our approach delivered 86% abstinence in the six months post-treatment versus 2% abstinence at the trial start and 25% in the current standard of care,” he continues.

“To put that in context, study participants went from being sober on average seven days a year to being sober on average 314 days a year on an annualized basis.”

“We are focused on addiction because there are few (if any) people whose lives have not been touched by addiction. Alcohol Use Disorder affects 285 million people globally. It destroys families, lives and, sadly, often kills.”

These positive developments follow the company’s 27% revenue growth in Q3 2022 and suggest that while the business is still in the nascent stages of growth, its underlying value proposition is well advanced and nearing a level of sustainable maturation.

STIFEL GMP analyst Andrew Partheniou recently rated the company a speculative Buy on news of Awakn’s Phase III trial, stating in a report that “government funding for 66% of the total trial cost” is “significantly reducing AWKN’s out-of-pocket expense to just over US$1 million.”

His report goes on to detail how “AWKN signed its third licensing agreement in North America, this time with Nushama, an operator in New York City. The offering is expected to be attractive to patients, providing better efficacy at a fraction of standard offerings (min. US$50k in NYC vs. AWKN at US$12.5k), with Nushama paying AWKN an annual fee and undisclosed royalty.”

Partheniou is optimistic that while clinic revenue could reach US$10 million by 2024, its real growth will come from licensing agreements. However, licensing and ketamine therapy aren’t the only tools that Awakn has to work with.

In a July report, H.C. Wainwright & Co. Analyst Patrick Trucchio focused on the company’s concurrent trials involving the equally ‘circumspect’ pharmaceutical MDMA. “We estimate (that MDMA-assisted therapy) could have blockbuster drug potential based on the significant unmet medical need and evidence generated to date pointing to the potential of MDMA-assisted therapy in a variety of mood disorders,” Trucchio explained.

“Moreover, Awakn’s MDMA-assisted therapy has generated promising Phase 2a data in AUD (alcohol use disorder), which follows the validation of the approach in PTSD in a late-stage program being conducted by MAPS, a non-profit organization based in the U.S.”

Awakn is currently pursuing four R&D programs, three live and one paused. The live programs focus on the following:

  • Ketamine combined with therapy to treat AUD, with Phase II complete and Phase III planned for 2023
  • Repurposing ketamine combined with therapy to treat behavioral addictions, with feasibility activity ongoing and Phase II planned for 2023
  • Developing MDMA in partnership with Catalent to address its known IP and pharmacokinetics challenges in order to increase the probability of developing MDMA into a successfully marketed drug to treat addictions with trauma as a causative factor.

The fourth, paused, program involves developing New Chemical Entity (NCE) candidates with properties similar to MDMA to treat addictions and mental health conditions with the poorest current standards of care, trauma as a causative factor, and the most significant total addressable markets.

Ownership and Share Structure

Awakn’s management owns 18.82% of the company’s 32,476,187 common shares.  Awakn also has 9,049,240 warrants, 2,971,746 stock options, and 35,172 DSUs outstanding for a fully diluted of 44,532,345.

OrbiMed Advisors LLC files as an insider, with a 7.40% equity stake (2,403,550 regular shares) and 989,583 warrants exercisable at prices of CA$1.80 or higher.

According to Reuters, 18.27% of shares are held by institutions and strategic investors, 8.35% by investment managers, and 9.93% by individual investors.

The company is covered by a myriad of analysts, including previously mentioned Andrew Partheniou of Stifel and Patrick Trucchio of H.C. Wainwright & Co. The company has also been reviewed by Jason McCarthy of Maxim Group and technical analyst Clive Maund of Clivemaund.com. You can click “See More Live Data” in the data box above to read more of what they are saying.

Other institutional investors of note include Iter Investments, Palo Santo, Negev Capital, Neo Kuma, TD Veen, JLS, and Ambria. The company’s market cap is US$ 7,354,000.

Disclosures:

1) Owen Ferguson wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. They members of their household own securities of the following companies mentioned in the article: None. They or members of their household are paid by the following companies mentioned in this article: None.

2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security. As of the date of this article, an affiliate of Streetwise Reports has a consulting relationship with Awakn Life Sciences Corp. Please click here for more information.

3) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal  disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.

4) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Awakn Life Sciences Corp., a company mentioned in this article.

5) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Biopharma Co.’s Burn Tissue Removal Product Approved

Source: Swayampakula Ramakanth  (1/4/23)

Because of the green light from the U.S. Food and Drug Administration, H.C. Wainwright & Co. raised its target price on the developer of this drug, according to a recent report.

Vericel Corp.’s (VCEL:NASDAQ) NexoBrid, a product that removes nonviable burn tissue, was recently approved and given a wider label than expected by the U.S. Food and Drug Administration (FDA), reported H.C. Wainwright & Co. analyst Dr. Swayampakula Ramakanth in a Jan. 3 research note. Vericel expects to commercially launch the drug in Q2/23.

“We expect management to provide additional details of the commercial launch in Q1/23 at an investor conference,” Ramakanth wrote.

On the news of the FDA approval, H.C. Wainwright increased its price target on Vericel to US$37 per share from US$35, the analyst pointed out. The biopharma is trading now at about $26.34 per share. The investment bank also reiterated its Buy rating on it.

Approved Uses

Ramakanth reported that NexoBrid is approved for adults with deep partial thickness and/or full-thickness thermal burns.

Patients may apply it to these burns twice within a 24-hour period, first to an area of up to 15% of their body surface area and second to an area of up to 20% of their body surface area.

Milestone Payment Due

NexoBrid is the result of a collaboration between Vericel and MediWound, Ramakanth indicated. Now that the drug is FDA approved, Vericel owes MediWound a milestone payment of US$7.5 million ($7.5M), payable in this first quarter of 2023.

Rationale for a New Target

H.C. Wainwright derived its new price target on Vericel based on a few assumptions, Ramakanth noted. One is that Vericel will initially garner US$6,500 per patient per burn treatment.

Another is that the biopharma will start generating revenue from NexoBrid in Q3/23. The third is that Vericel’s revenue from NexoBrid in 2023 will be an estimated US$8.5M and, by year-end 2026, will be about US$31M.

Disclosures:
1) Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.

2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

3) Statements and opinions expressed are the opinions of the author and not of Streetwise Reports or its officers. The author is wholly responsible for the validity of the statements. The author was not paid by Streetwise Reports for this article. Streetwise Reports was not paid by the author to publish or syndicate this article. Streetwise Reports requires contributing authors to disclose any shareholdings in, or economic relationships with, companies that they write about. Streetwise Reports relies upon the authors to accurately provide this information and Streetwise Reports has no means of verifying its accuracy.

4) This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.

5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Disclosures For H.C.Wainwright & Co., MediWound Ltd.,  January 3, 2023

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Swayampakula Ramakanth, Ph.D., Arthur He, Ph.D. and Sean Lee , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst’s household has a financial interest in the securities of Vericel Corporation and MediWound Ltd. (including, without limitation, any option, right, warrant, future, long or short position). As of December 31, 2022 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Vericel Corporation and MediWound Ltd.

Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report. The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The Firm or its affiliates did not receive compensation from Vericel Corporation for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm or its affiliates did receive compensation from MediWound Ltd. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for MediWound Ltd. during the past 12 months.

The Firm does not make a market in Vericel Corporation and MediWound Ltd. as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person.

H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report.

H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report. H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.

The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice. Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.

Tech. Analyst Says Pharma Co. Is at a Favorable Risk/Reward Ratio

Source: Clive Maund  (12/28/22) 

Technical analyst Clive Maund reviews Algernon Pharmaceuticals Inc.’s 6-month, 3-year, and 9-year charts to tell you whether you should be interested in this pharma company.

Another stock that appears to be at stony rock bottom is Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGN0:XFRA), and it has two things going for it — one is that it could come out with positive news at any time that could get it moving and the other is that, with only 2.3 million shares in issue, when it does move it is likely to result in big percentage gains, as happened back last January when it rocketed from CA$4 to CA$12 in a matter of a couple of weeks, a move which we rode.

On its 6-month chart, we can see that after dropping hard in mid-October, it has marked out a low trading range that has allowed downside momentum to drop out and the 50-day moving average has dropped down close to the price, in the process opening up a quite large gap between it and the 200-day and these factors taken together make a rally soon increasingly likely with the relatively strong Accumulation line over the past several months being another positive factor.

Zooming out on a 3-year chart enables us to put recent action in more perspective (note that this chart and the 9-year we are also looking at have been adjusted for a one-for-100-share rollback about a year ago, which explains the low number of shares in issue).

On this chart, we see that Algernon is now extraordinarily cheap as it has dropped back from a peak at over CA$53 in 2020 to the current miserly price of CA$2.50. The worst decline was behind it by late last year, since which time, although it has continued to make new lows, the rate of decline has slowed, with, as mentioned above, the Accumulation line showing a marked positive divergence in recent months.

The 9-year chart shows us the entire history of the stock, and on this chart, we see that it got to even higher levels than we saw in 2020, as back in 2016, shortly after it started trading, it got close to CA$110 and at the start of 2018 it spiked to about CA$103.

It looks like it is making a cyclical low here, close to the late 2019 lows.

Even without factoring in the extremely low number of shares in issue, Algernon looks like it is at a low here with a very favorable risk/reward ratio, which is magnified enormously by the low number of shares in issue, as any good news coming through – and there is believed to be some coming through soon — could see it take off strongly higher.

Algernon is therefore rated a strong speculative Buy here.

Algernon Pharmaceuticals’ website

Algernon Pharmaceuticals Inc. closed at CA$2.50, $1.76 on December 20, 2022.

CliveMaund.com Disclosures

The above represents the opinion and analysis of Mr. Maund, based on data available to him, at the time of writing. Mr. Maund’s opinions are his own, and are not a recommendation or an offer to buy or sell securities. Mr. Maund is an independent analyst who receives no compensation of any kind from any groups, individuals or corporations mentioned in his reports. As trading and investing in any financial markets may involve serious risk of loss, Mr. Maund recommends that you consult with a qualified investment advisor, one licensed by appropriate regulatory agencies in your legal jurisdiction and do your own due diligence and research when making any kind of a transaction with financial ramifications. Although a qualified and experienced stock market analyst, Clive Maund is not a Registered Securities Advisor. Therefore Mr. Maund’s opinions on the market and stocks can only be construed as a solicitation to buy and sell securities when they are subject to the prior approval and endorsement of a Registered Securities Advisor operating in accordance with the appropriate regulations in your area of jurisdiction.

Disclosures:
1) Clive Maund: I, or members of my immediate household or family, own securities of the following companies mentioned in this article: None. I personally am, or members of my immediate household or family are, paid by the following companies mentioned in this article: None.

2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: Algernon Pharmaceuticals Inc. Click here for important disclosures about sponsor fees. As of the date of this article, an affiliate of Streetwise Reports has a consulting relationship with Algernon Pharmaceuticals Inc. Please click here for more information.

3) Statements and opinions expressed are the opinions of the author and not of Streetwise Reports or its officers. The author is wholly responsible for the validity of the statements. The author was not paid by Streetwise Reports for this article. Streetwise Reports was not paid by the author to publish or syndicate this article. Streetwise Reports requires contributing authors to disclose any shareholdings in, or economic relationships with, companies that they write about. Streetwise Reports relies upon the authors to accurately provide this information and Streetwise Reports has no means of verifying its accuracy.

4) This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.

5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Algernon Pharmaceuticals Inc., a company mentioned in this article.

6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Biotech at Good Entry Point for Investors, Analyst Says

Source: Andrew Partheniou  (12/20/22)

The company, focused on psychedelic-assisted psychotherapies to better treat addiction, is worth more than the CA$10 million the market is valuing it at, noted a Stifel report.

Awakn Life Sciences Corp. (AWKN:NEO; AWKNF:OTCQB) is currently undervalued and, thus, providing investors an attractive time to get into the stock, reported Stifel analyst Andrew Partheniou in a Dec. 16 research note.

With the Canadian biotech firm, the “market sees about a CA$10 million ($10M) valuation,” he wrote. “We see a Phase 3 company with a derisked molecule.”

Further, Awakn offers significant potential return for investors given the difference between its current share price (CA$0.40) and Stifel’s target price on it (CA$1.75). As such, Stifel rates the biotech Speculative Buy.

The reasons Stifel considers Awakn undervalued are its three recent key accomplishments, Partheniou wrote, “despite a materially challenging market backdrop.”

Recent Progress Made

1) Awakn completed the second tranche of its capital raise, generating US$1.9M. The two tranches together and debt settlement yielded US$3M, enough to get it through the next three quarters, Partheniou wrote.

“This could provide the company with time to realize some potential catalyst to create shareholder value through derisking its outlook and pursue another equity financing,” he added.

2) Awakn partnered with the British government on the life sciences firm’s Phase 3 pivotal trial of ketamine for alcohol use disorder, and it will be conducted at seven National Health Service sites. Also, the company secured governmental funding in the form of a grant that will cover 66% of the trial cost, or CA$3.75M, dropping Awakn’s contribution at CA$1.25M, “a significantly advantageous position,” noted Partheniou.

3) Awakn further grew its ketamine clinic business, adding locations in Norway and the U.S. reported Partheniou. In Norway, the biotech signed a lease for a second location, expected to be up and running by late Q1/23. The company also entered a licensing agreement with Nushama in New York, making it the third such arrangement in North America. Nushama will pay Awakn an annual fee and a royalty of an unknown amount.

“Hence, we see good momentum overall,” wrote Partheniou.

Disclosures:
1) Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.

2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security. As of the date of this article, an affiliate of Streetwise Reports has a consulting relationship with: Awakn Life Sciences Corp. Please click here for more information.

3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal  disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.

5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Awakn Life Sciences Corp., a company mentioned in this article.

6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Disclosures For Stifel GMP, Awakn Life Sciences Corp a.nd Cybin Inc.,  December 16, 2022

I, Andrew Partheniou, certify that the views expressed in this research report accurately reflect my personal views about the subject securities or issuers; and I, Andrew Partheniou, certify that no part of my compensation was, is, or will be directly or indirectly related to the specific recommendations or views contained in this research report.

Stifel or an affiliate expects to receive or intends to seek compensation for investment banking services from Awakn Life Sciences Corp. in the next 3 months. The equity research analyst(s) responsible for the preparation of this report receive(s) compensation based on various factors, including Stifel’s overall revenue, which includes investment banking revenue.

The information contained herein has been prepared from sources believed to be reliable but is not guaranteed by us and is not a complete summary or statement of all available data, nor is it considered an offer to buy or sell any securities referred to herein. Opinions expressed are as of the date of this publication and are subject to change without notice. These opinions do not constitute a personal recommendation and do not take into account the particular investment objectives, financial situation or needs of individual investors. Employees of Stifel, or its affiliates may, at times, release written or oral commentary, technical analysis or trading strategies that differ from the opinions expressed within. Stifel or any of its affiliates may have positions in the securities mentioned and may make purchases or sales of such securities from time to time in the open market or otherwise and may sell to or buy from customers such securities on a principal basis; such transactions may be contrary to recommendations in this report. Past performance should not and cannot be viewed as an indicator of future performance.

Unless otherwise noted, the financial instruments mentioned in this report are priced as of market close on the previous trading day and presumed performance is calculated always over the next 12 months. As a multi-disciplined financial services firm, Stifel regularly seeks investment banking assignments and compensation from issuers for services including, but not limited to, acting as an underwriter in an offering or financial advisor in a merger or acquisition, or serving as a placement agent in private transactions.

Affiliate Disclosures: References to “Stifel” (collectively ”Stifel”) refer to SFC and other associated affiliated subsidiaries including (i) Stifel, Nicolaus & Company, Incorporated (“SNC”); (ii) Keefe, Bruyette & Woods, Incorporated (“KBWI’’), which are both U.S. broker-dealers registered with the United States Securities and Exchange Commission (“SEC”) and members of the Financial Industry National Regulatory Authority (“FINRA”), respectively; (iii) Stifel Nicolaus Canada, Incorporated. (“Stifel Canada”), which is authorised and regulated by Investment Industry Regulatory Organization of Canada (“IIROC”), and also trades under the names “Stifel GMP” and/or “Stifel FirstEnergy”; (iv) Stifel Nicolaus Europe Limited (“SNEL”), which is authorised and regulated by the Financial Conduct Authority (“FCA”) (FRN 190412) and is a member of the London Stock Exchange and also trades under the name Keefe, Bruyette & Woods Europe (“KBW Europe”); (v) Stifel Europe Bank AG (“SEBA”), which is regulated by the German Federal Financial Supervisory Authority (Bundesanstalt für Finanzdienstleistungsaufsicht; “BaFin”) and is a member of Deutsche Boerse and SIX Swiss Exchange and (vi) Stifel Schweiz AG (“STSA”), which is representative of SEBA in Switzerland and regulated by the Eidgenössische Finanzmarktaufsicht (“FINMA”). SNEL, SEBA and STSA are collectively referred to as Stifel Europe.

Why One Fund Owns 13% of This Small-Cap Pharma

Source: Streetwise Reports  (12/12/22)

Clinical-stage Algernon Pharmaceuticals’ multiple pipelines include testing a psychedelic for the treatment of stroke, and testing other drugs for idiopathic pulmonary fibrosis and chronic kidney disease.

Clinical-stage drug development company Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGN0:XFRA) has multiple drugs in its pipeline and has garnered the support of AlphaNorth Asset Management, which now holds approximately 13% of the firm’s shares.

Why has the firm taken such a large position? AlphaNorth President and CEO Steve Palmer explained in a recent episode of Streetwise Live!: “We like it primarily because of the valuation. It’s quite cheap. Currently, the value of the whole company is CA$6–7 million. We also like it because they have multiple programs; I like companies like have multiple shots on goal, so to speak. And the trials that they are conducting are also lower risk than the typical biotech because they are using drugs that are already known to be safe.”

Analyst Andre Uddin with Research Capital Corporation follows the company and notes that Algernon has an “in-depth pipeline based on its novel repurposing drug development strategy.” He has calculated a CA$10.25/share target price on the company, an implied fourfold return based on the current share price of CA$2.78.

Multiple Pipelines

Algernon is about to begin testing the psychedelic compound DMT (N, N-dimethyltryptamine) for ischemic stroke, the type of stroke caused by blood clots blocking the flow of blood in the brain. The current treatment, tPA, must be administered within about three hours of the start of symptoms to be effective, a threshold that a large proportion of stroke victims don’t meet.

“The trials that they are conducting are also lower risk than the typical biotech,” said Steve Palmer of AlphaNorth Asset Management

The company has commenced screening subjects for the Phase 1 clinical study that will be conducted at the Centre for Human Drug Research in The Netherlands and expects to dose the first subject soon. Up to 60 healthy volunteers are expected to participate.

Algernon notes that the purpose of the study is to identify the “safety, tolerability, and pharmacokinetics of DMT when administered as an intravenous bolus followed by a prolonged infusion, for durations which have never been studied clinically. In addition, several pharmacodynamic measures believed to be associated with neuroplasticity, including both measurements of biochemical markers and electroencephalographic readings, will be recorded.”

“The potential of a stroke treatment drug is enormous,” Christopher Moreau, CEO of Algernon, stated. “On the human side, for approximately 85% of ischemic stroke patients, there is no treatment except to watch and hope. And on the market side, it is estimated to become a US$15 billion market by 2027, and so it’s truly global in scale and would have a huge impact on patients who suffer from this terrible injury.”

The company noted that its decision to investigate DMT and move it into human trials for stroke is “based on multiple independent, positive preclinical studies demonstrating that DMT, at a sub-psychedelic dose, helps promote structural and functional neuroplasticity. These are key factors involved in the brain’s ability to form and reorganize synaptic connections, which are needed for healing following a brain injury.”

Research Capital Corp. analyst Andre Uddin noted, “We believe AGN’s best asset is ifenprodil.”

“The preclinical data shows that DMT promotes the production of brain-derived neurotrophic factor, which is an important part of the brain’s recovery process after an injury like a stroke,” Moreau stated.

Because other Phase 1 studies have been completed on DMT, the company is not expecting any serious adverse events.

Algernon is also looking into DMT for additional indications. In late October, the company announced that it has entered into a clinical trial agreement with Yale University School of Medicine, New Haven, Conn., for the use of DMT in a Phase 2 depression study. “Although the treatment of psychiatric disorders with DMT [is] not the company’s current focus, we have patents pending on novel forms of DMT which could potentially be used across a broad range of diseases,” stated Moreau. “In addition, we believe the data generated from this study may help inform Algernon’s stroke research program.”

Orphan Drug Status for Ifenprodil for IPF

Algernon has received from the U.S. Food and Drug Administration Orphan Drug designation for Ifenprodil for the treatment of idiopathic pulmonary fibrosis (IPF). Orphan drug status is conferred on diseases that affect fewer than 200,000 patients in the U.S. and provides tax credits for trials and an exemption from user fees. If the drug receives FDA approval, seven years of market exclusivity are granted.

“We appreciate the U.S. FDA’s decision to grant ODD status to Ifenprodil for IPF, a disease for which prognosis remains dismal, with 50% mortality expected within three to four years,” said Moreau. “This regulatory milestone comes at an important time in the development of Ifenprodil as a potential new therapy for IPF as we plan the next steps for our clinical program.”

Technical analyst Clive Maund of CliveMaund.com recently charted Algernon’s stock and rated the stock a Buy.

Algernon’s Phase 2a study of Ifenprodil in patients recently concluded and met its co-primary endpoint “with patients receiving Ifenprodil experiencing no worsening of their lung function, and significant improvements were seen in the frequency of their IPF-associated cough as well. In addition, improvements in patient-reported measures of cough severity and quality of life were observed. Ifenprodil was also confirmed to be safe and well-tolerated in the study.”

Research Capital Corp. analyst Andre Uddin noted, “We believe AGN’s best asset is ifenprodil for treating refractory chronic cough (RCC) in idiopathic fibrosis (IPF)/IPF patients. . . Based on the positive Phase 2a data, we expect management to advance its 3x per day formulation of ifenprodil and initiate a Phase 2b trial in chronic cough H2 CY2023. A data set from a Phase 2b chronic cough trial would potentially be a large value-creating inflection point.”

Catalyst: Company Will Begin Testing For Chronic Kidney Disease Drug

The company plans to begin testing repirinast, a drug sold for 25 years in Japan for asthma, for chronic kidney disease. Analyst Uddin noted that Algernon “expects to begin conducting a Phase 1 study using repirinast to treat CKD in calendar year Q2 2023.”

Analysts and Expert Coverage

Technical analyst Clive Maund of CliveMaund.com recently charted Algernon’s stock and rated the stock a Buy. He wrote in October that “those interested should aim to buy it as soon as possible.”

of The National Investor also commented on the stock in a September post, saying that he considered the company an Immediate Buy.

The stock is also covered by analyst Dr. André Uddin of Research Capital Corp. and newsletter writers of The National Inflation Association, of 321gold.com, and of Pennyqueen.com. 

Click “See More Live Data” in the data box above to read more of what they are saying.

Ownership and Share Structure

AlphaNorth Asset Management is Algernon’s largest shareholder owning 13.46% of Algernon’s shares.

Algernon has approximately 2.3 million shares outstanding and 3.6 million fully diluted. It trades on the Canadian Securities Exchange under the ticker AGN and under the ticker AGNPF on the U.S. OTCQB platform.

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Disclosures:
1) Patrice Fusillo wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor.  She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.

2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: Algernon Pharmaceuticals Inc. Click here for important disclosures about sponsor fees. As of the date of this article, an affiliate of Streetwise Reports has a consulting relationship with Algernon Pharmaceuticals Inc. Please click here for more information.

3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.

5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Algernon Pharmaceuticals Inc., a company mentioned in this article.

6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Research Capital Corporation disclosures:

1. This Issuer has generated investment banking revenue for RCC.

Analyst Certification
I, Andre Uddin, Ph.D., certify the views expressed in this report were formed by my review of relevant company data and industry investigation, and accurately reflect my opinion about the investment merits of the securities mentioned in the report. I also certify that my compensation is not related to specific recommendations or views expressed in this report. Research Capital Corporation publishes research and investment recommendations for the use of its clients. Information regarding our categories of recommendations, quarterly summaries of the percentage of our recommendations which fall into each category and our policies regarding the release of our research reports is available at www.researchcapital.com or may be requested by contacting the analyst. Each analyst of Research Capital Corporation whose name appears in this report hereby certifies that (i) the recommendations and opinions expressed in this research report accurately reflect the analyst’s personal views and (ii) no part of the research analyst’s compensation was or will be directly or indirectly related to the specific conclusions or recommendations expressed in this research report.

CliveMaund.com disclosures:

Clive Maund has not been paid by the company and does not own shares of Algernon.

Biotech Co.’s Shares Soar to New 52-Week High

Source: Streetwise Reports  (12/7/22)

Prometheus Biosciences Inc. shares traded 170% higher to a new 52-week intraday high after the company reported positive results from two separate Phase 2 clinical studies for its PRA023, an anti-TL1A mAb used to treat inflammatory bowel disease. The company is actively planning to advance PRA023 into Phase 3 trials as a prospective treatment for ulcerative colitis and Crohn’s disease in FY/23.

Clinical-stage biotech company Prometheus Biosciences Inc. (RXDX:NASDAQ), which is engaged in the discovery, development, and commercialization of medicines for use in the treatment of immune-mediated diseases such as inflammatory bowel disease (IBD), today announced “results from its ARTEMIS-UC Phase 2 and APOLLO-CD Phase 2a studies of PRA023 demonstrating strong efficacy and favorable safety results in both studies.”

The firm advised that based upon the data collected during both of these independent Phase 2 trials, it plans to initiate discussions with regulators to move forward with two additional Phase 3 studies of PRA023 in FY/23 for the treatment of Crohn’s disease (CD) and ulcerative colitis (UC).

Prometheus advised that in its Phase 2 ARTEMIS-UC trial, “PRA023 met the primary and all ranked secondary endpoints including clinical, endoscopic, histologic, and patient-reported outcome measures in the initial cohort (Cohort 1) of the trial.”

In the double-blind, randomized ARTEMIS-UC trial, 135 patients with moderate-to-severely active UC who did not respond to prior therapies were treated over a period of 12 weeks with either PRA023 or placebo. The topline data showed that 26.5% of patients on PRA023 successfully achieved the predetermined primary endpoint of clinical remission versus just 1.5% in the control group. Additionally, 36.8% of the patients who receive PRA023 met the key secondary endpoint of endoscopic improvement, compared to 6.0% for those who were administered a placebo.

RXDX shares opened almost 200% higher today at US$105.07 (+US$69.01, +191.38%) over yesterday’s US$36.06 closing price and reached a new 52-week high price this morning of US$111.99.

The firm also reported positive findings in its Phase 2a APOLLO-CD trial, which enrolled a total of 55 patients diagnosed with a moderate-to-severely active CD with endoscopically active disease who also had failed other standard treatment regimens.

Results from the APOLLO-CD study demonstrated that 26.0% of patients who received PRA023 achieved endoscopic response versus the historical average placebo rate of 12%. In addition, 49.1% of trial participants’ patients administered PRA023 achieved clinical remission, compared to the historical placebo group rate of 16%.

Prometheus Biosciences’ Chairman and CEO Mark McKenna commented, “We are beyond enthusiastic with these study results and what they could mean for patients suffering from IBD. The performance of PRA023 in both UC and Crohn’s patients has surpassed our expectations . . . We believe PRA023 and our precision medicine approach [have] the potential to change the paradigm of IBD treatment, and we look forward to discussions with regulatory agencies as we prepare to advance into Phase 3 studies in Ulcerative Colitis and Crohn’s Disease.”

The company’s Chief Medical Officer Allison Luo, M.D. remarked, “PRA023 has clearly demonstrated clinical proof-of-concept in CD and remarkable efficacy for the treatment of UC . . . We look forward to further evaluating PRA023 in Phase 3 studies with the goal of bringing this promising candidate to the market.”

The firm explained that “PRA023 is an IgG1 humanized monoclonal antibody that has been shown to block tumor necrosis factor (TNF)-like ligand 1A (TL1A).” The company indicated that PRA023 shows the potential to substantially improve outcomes for patients with moderate-to-severe IBD in those persons predisposed to increased TL1A expression. In addition to prospective uses in the treatment of UC and CD, Prometheus is also investigating and developing PRA023 for use in treating systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Prometheus Biosciences is a clinical-stage biotechnology firm based in San Diego, Calif., that is focused on discovering, developing, and commercializing novel therapeutics to treat immune-mediated diseases. The firm has created a precision medicine platform called Prometheus360™, which utilizes machine learning technology to query gastrointestinal bioinformatics databases to identify potential new therapeutic targets. The firm’s activities were initially focused mostly on gastrointestinal (GI) diseases such as IBD, but it is now expanding its efforts to target other autoimmune diseases.

Prometheus Biosciences started off the day with a market cap of around US$1.51 billion, with approximately 41.94 million shares outstanding and a short interest of about 11.6%. RXDX shares opened almost 200% higher today at US$105.07 (+US$69.01, +191.38%) over yesterday’s US$36.06 closing price and reached a new 52-week high price this morning of US$111.99. The stock has traded today between US$95.50 and US$111.99 per share and is currently trading at US$97.82 (+US$61.76, +171.27%).

Disclosures:

1) Stephen Hytha wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.

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3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.

5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Expert Says Health Tech Co. Is in Another Buy Spot

Source: Clive Maund  (11/30/22)

Expert Clive Maund reviews the 1-year chart for Reliq Health Technologies to tell you why he believes it is in another buy spot.

We caught a perfect buy spot when we went for Reliq Health Technologies Inc. (RHT:TSX.V; RQHTF:OTCQB; A2AJTB:WKN) at the start of the month (it was recommended in a Market Notebook update), as right after it proceeded to break out of a quite large Head-and-Shoulders bottom to rise quite steeply, resulting in good percentage gains for us in a short space of time.

The purpose of this update is to point out that it still looks good here.

It is, in fact, at another buy spot as it is starting to break out of a completing bull Flag that has formed over the past couple of weeks, as we can see on its latest 1-year chart below.

November 21, 2022, would have been the perfect time to buy, of course, because it ended up adding CA$0.04 by the end of the day, but it still looks good here as a breakout from the Flag should lead to a rally of similar magnitude to the one preceding the Flag.

We, therefore, stay long and this is a good point to add to positions or make fresh purchases. Reliq trades in reasonable volumes on the US OTC market.

Reliq Health Tech closed for trading at CA$0.71, $0.54 on November 21, 2022. It is currently trading at CA$0.69.

CliveMaund.com Disclosures

The above represents the opinion and analysis of Mr. Maund, based on data available to him, at the time of writing. Mr. Maund’s opinions are his own, and are not a recommendation or an offer to buy or sell securities. Mr. Maund is an independent analyst who receives no compensation of any kind from any groups, individuals or corporations mentioned in his reports. As trading and investing in any financial markets may involve serious risk of loss, Mr. Maund recommends that you consult with a qualified investment advisor, one licensed by appropriate regulatory agencies in your legal jurisdiction and do your own due diligence and research when making any kind of a transaction with financial ramifications. Although a qualified and experienced stock market analyst, Clive Maund is not a Registered Securities Advisor. Therefore Mr. Maund’s opinions on the market and stocks can only be construed as a solicitation to buy and sell securities when they are subject to the prior approval and endorsement of a Registered Securities Advisor operating in accordance with the appropriate regulations in your area of jurisdiction.

Disclosures:
1) Clive Maund: I, or members of my immediate household or family, own securities of the following companies mentioned in this article: None. I personally am, or members of my immediate household or family are, paid by the following companies mentioned in this article: None.

2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: Reliq Health Technologies Inc. Click here for important disclosures about sponsor fees.

3) Statements and opinions expressed are the opinions of the author and not of Streetwise Reports or its officers. The author is wholly responsible for the validity of the statements. The author was not paid by Streetwise Reports for this article. Streetwise Reports was not paid by the author to publish or syndicate this article. Streetwise Reports requires contributing authors to disclose any shareholdings in, or economic relationships with, companies that they write about. Streetwise Reports relies upon the authors to accurately provide this information and Streetwise Reports has no means of verifying its accuracy.

4) This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.

5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Reliq Health Technologies Inc., a company mentioned in this article.