Emerita Resources Corp. (EMO:TSX.V; EMOTF:OTCQB; LLJA:FSE) announces results from a metallurgical testing program at its wholly-owned Iberian Belt West (IBW) project in Spain. Read why one expert says the company is in "the right place to be."

Michael Ballanger of GGM Advisory Inc. shares an update on his thoughts on the gold, silver, and copper sectors.

Global Analyst Adrian Day reviews financials and preliminary reports from some major resource companies as well as developments at others. He also answers a reader's question on Newmont: is it a good buy after the sharp drop after its earnings?

Giant Mining Corp. (CSE: BFG; OTC:BFGFF; FWB:YW5) announced the expansion of its surface exploration program at the Majuba Hill copper-silver deposit in Pershing County, Nevada. Read more to learn about the promising high-grade copper findings and the project's potential impact on the EV and renewable energy sectors.

Stillwater Critical Minerals Corp. (PGE:TSX.V; PGEZF:OTCQB; J0G:FSE) has announced new assay results from its ongoing resource expansion drilling at the Stillwater West PGE-Ni-Cu-Co + Au project. Read more for detailed insights into the high-grade rhodium intercepts and resource expansion potential.

This Buy-rated Canadian explorer-developer is working to achieve first mover status in this emerging clean energy space. Find out what all it has done and is doing.

Hercules Metals Corp. (BADEF:OTCMKTS; BIG:TSXV) has announced advancements in its exploration efforts at the western Idaho Leviathan porphyry copper system. Read more about the significant shallow mineralization discoveries and new target areas that could indicate further resource potential.

Michael Ballanger of GGM Advisory Inc. shares his thoughts on the silver market and shares one copper stock he believes is a Strong Speculative Buy even though the stock is currently halted.

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Needle pricks not your thing? A team of National Science Foundation-funded scientists is developing wearable skin sensors that can detect what's in your sweat. They hope that one day, monitoring perspiration could bypass the need for more invasive procedures like blood draws, and provide real-time updates on health problems such as dehydration or fatigue. In a new paper, the team describes a new sensor design that can be rapidly manufactured using a "roll-to-roll" processing technique that essentially prints the sensors onto a sheet of plastic like words on a newspaper. They used the sensors to monitor the sweat rate, and the electrolytes and metabolites in sweat, from volunteers who were exercising, and others who were experiencing chemically induced perspiration. The new sensors contain a spiraling microscopic tube, or microfluidic, that wicks sweat from the skin. By tracking how fast the sweat moves through the microfluidic, the sensors can report how much a person is sweating, or their sweat rate. The microfluidics are also outfitted with chemical sensors that can detect concentrations of electrolytes like potassium and sodium, and metabolites like glucose.

Image credit: Bizen Maskey/Sunchon National University

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Earth's magnetic field seems steady and true -- reliable enough to navigate by. Yet, largely hidden from daily life, the field drifts, waxes and wanes. The magnetic North Pole is currently shifting toward Siberia, forcing the Global Positioning System that underlies modern navigation to update its software sooner than expected. Every several hundred thousand years, the magnetic field dramatically shifts and reverses its polarity. Magnetic north flips to the geographic South Pole and, eventually, back again. This reversal has happened countless times over Earth's history, but scientists' understanding of why and how the field reverses is limited. The researchers find that the most recent field reversal 770,000 years ago took at least 22,000 years to complete, several times longer than previously thought. The results call into question controversial findings that some reversals could occur within a human lifetime.

Image credit: Brad Singer

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A National Science Foundation-funded research has discovered the root cause of why lithium metal batteries fail -- bits of lithium metal deposits break off from the surface of the anode during discharging and are trapped as "dead" or inactive lithium that the battery can no longer access. The discovery challenges the conventional belief that lithium metal batteries fail because of the growth of a layer, called the solid electrolyte interphase (SEI), between the lithium anode and the electrolyte. The researchers made their discovery by developing a technique to measure the amounts of inactive lithium species on the anode -- a first in the field of battery research -- and studying their micro- and nanostructures. The findings could pave the way for bringing rechargeable lithium metal batteries from the lab to the market.

Image credit: University of California - San Diego

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A National Science Foundation-funded study found that Charles Darwin's famous finches defy what has long been considered a key to evolutionary success: genetic diversity. The research on finches of the Galapagos Islands could change the way conservation biologists think about a species' potential for extinction in naturally fragmented populations. Researchers examined 212 tissue samples from museum specimens and living birds. Some of the museum specimens in the study were collected by Darwin himself in 1835. Only one of the extinct populations, a species called the vegetarian finch, had lower genetic diversity compared to modern survivors. Specifically, researchers believe a biological phenomenon called sink-source dynamics is at play in which larger populations of birds from other islands act as a "source" of immigrants to the island population that is naturally shrinking, the "sink." Without these immigrant individuals, the natural population on the island likely would continue to dwindle to local extinction. The immigrants have diverse genetics because they are coming from a variety of healthier islands, giving this struggling "sink" population inflated genetic diversity.

Image credit: Jose Barreiro

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A new study shows that the West Antarctic Peninsula is experiencing some of the most rapid climate change on Earth, featuring dramatic increases in temperatures, retreats in glaciers and declines in sea ice. The Southern Ocean absorbs nearly half of the carbon dioxide -- the key greenhouse gas linked to climate change -- that is absorbed by all the world's oceans. The study tapped an unprecedented 25 years of oceanographic measurements in the Southern Ocean and highlights the need for more monitoring in the region. The research revealed that carbon dioxide absorption by surface waters off the West Antarctic Peninsula is linked to the stability of the upper ocean, along with the amount and type of algae present. A stable upper ocean provides algae with ideal growing conditions. During photosynthesis, algae remove carbon dioxide from the surface ocean, which in turn draws carbon dioxide out of the atmosphere. From 1993 to 2017, changes in sea ice dynamics off the West Antarctic Peninsula stabilized the upper ocean, resulting in greater algal concentrations and a shift in the mix of algal species. That's led to a nearly five-fold increase in carbon dioxide absorption during the summertime. The research also found a strong north-south difference in the trend of carbon dioxide absorption. The southern portion of the peninsula, which to date has been less impacted by climate change, experienced the most dramatic increase in carbon dioxide absorption, demonstrating the poleward progression of climate change in the region.

Image credit: Drew Spacht/The Ohio State University

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On August 17, 2017, scientists made history with the first direct observation of a merger between two neutron stars. It was the first cosmic event detected in both gravitational waves and the entire spectrum of light, from gamma rays to radio emissions. The impact also created a kilonova -- a turbocharged explosion that instantly forged several hundred planets’ worth of gold and platinum. The observations provided the first compelling evidence that kilonovae produce large quantities of heavy metals, a finding long predicted by theory. Astronomers suspect that all of the gold and platinum on Earth formed as a result of ancient kilonovae created during neutron star collisions. Based on data from the 2017 event, first spotted by the Laser Interferometer Gravitational-wave Observatory (LIGO), astronomers began to adjust their assumptions of how a kilonova should appear to Earth-bound observers. A team of scientists reexamined data from a gamma-ray burst spotted in August 2016 and found new evidence for a kilonova that went unnoticed during the initial observations.

Image credit: NASA/ESA/E. Troja

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National Science Foundation (NSF)-funded researchers from North Carolina State and Elon universities have developed a technique that allows them to remotely control the movement of soft robots, lock them into position for as long as needed and later reconfigure the robots into new shapes. The technique relies on light and magnetic fields. "By engineering the properties of the material, we can control the soft robot's movement remotely; we can get it to hold a given shape; we can then return the robot to its original shape or further modify its movement; and we can do this repeatedly. All of those things are valuable, in terms of this technology's utility in biomedical or aerospace applications," says Joe Tracy, a professor of materials science and engineering at NC State and corresponding author of a paper on the work. In experimental testing, the researchers demonstrated that the soft robots could be used to form "grabbers" for lifting and transporting objects. The soft robots could also be used as cantilevers or folded into "flowers" with petals that bend in different directions. "We are not limited to binary configurations, such as a grabber being either open or closed," says Jessica Liu, first author of the paper and a Ph.D. student at NC State. "We can control the light to ensure that a robot will hold its shape at any point."

Image credit: Jessica A.C. Liu

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Bridges make travel faster and more convenient, but, in an earthquake, these structures are subject to forces that can cause extensive damage and make them unsafe. Now civil and environmental engineer Petros Sideris of Texas A&M University is leading a National Science Foundation (NSF)-funded research project to investigate the performance of hybrid sliding-rocking (HSR) columns. HSR columns provide the same support as conventional bridge infrastructure columns but are more earthquake-resistant. HSR columns are a series of individual concrete segments held together by steel cables that allow for controlled sliding and rocking. This allows the columns to shift without damage, while post-tensioning strands ensure that at the end of an earthquake the columns are pushed back to their original position. Conventional bridges are cast-in-place monolithic concrete elements that are strong but inflexible. Structural damage in these bridge columns, typically caused by a natural disaster, often forces a bridge to close until repairs are completed. But bridges with HSR columns can withstand large earthquakes with minimal damage and require minor repairs, likely without bridge closures. Such infrastructure helps with post-disaster response and recovery and can save thousands in taxpayer dollars. In an earthquake, HSR columns provide "multiple advantages to the public," Sideris said. "By preventing bridge damage, we can maintain access to affected areas immediately after an event for response teams to be easily deployed, and help affected communities recover faster. In mitigating losses related to post-event bridge repairs and bridge closures, more funds can be potentially directed to supporting the recovery of the affected communities." According to Joy Pauschke, NSF program director for natural hazards engineering, "NSF invests in fundamental engineering research so that, in the future, the nation's infrastructure can be more resilient to earthquakes, hurricanes, and other forces of nature."

Image credit: Texas A&M University

Source: Dr. Ram Selvaraju 10/18/2024

H.C. Wainwright & Co. analyst Dr. Ram Selvaraju, in a research report published on October 18, 2024, reiterated a Buy rating on Anavex Life Sciences Corp. (AVXL:NASDAQ) with a price target of US$40.00. The report follows Anavex's announcement of encouraging preliminary electroencephalography (EEG) biomarker results from Part A of the ongoing Phase 2 clinical study of ANAVEX3-71 for schizophrenia treatment.

Selvaraju highlighted the significance of these results, stating, "Preliminary results demonstrated a dose-dependent effect of ANAVEX3-71 on two key EEG biomarkers in patients with schizophrenia. Treatment with ANAVEX3-71 vs. placebo resulted in improvements in 40 Hz Auditory Steady-State Response (ASSR) Inter Trial Coherence (ITC) and Resting State Alpha Power."

The analyst viewed these developments positively, noting, "These results provide evidence of CNS target engagement and potential therapeutic effects of ANAVEX3-71 in schizophrenia. The observed changes reversed known EEG and ERP biomarker abnormalities associated with schizophrenia."

Regarding Anavex's lead candidate, blarcamesine, Selvaraju stated, "Anavex remains committed to completing the Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) under the Centralized Procedure petitioning for approval of blarcamesine for treatment of Alzheimer's disease (AD) in 4Q24."

The report also highlighted Anavex's progress with other clinical programs, including a pivotal Phase 2b/3 trial in Parkinson's disease and potential trials in Rett syndrome and Fragile X Syndrome.

Selvaraju's valuation methodology for Anavex Life Sciences is based on a discounted cash flow (DCF) approach. He explained, "We utilize a discounted cash flow (DCF)-driven methodology, which ascribes a total value of roughly US$3.25B to blarcamesine alone without ascribing value to any other pipeline assets. We employ a 50% probability of approval in Rett syndrome; 60% in Parkinson's disease dementia (PDD); and 50% in AD."

The analyst added, "Further, we apply a 12% discount rate and 1% terminal growth rate. We derive a total firm value of ~US$3.4B, which yields a 12-month price objective of US$40 per share, assuming 84.8M shares outstanding as of end-F2Q25."

Selvaraju also outlined several risk factors, including potential negative clinical data, regulatory approval challenges, and commercialization difficulties.

In conclusion, H.C. Wainwright & Co.'s maintenance of a Buy rating and US$40 price target reflects a positive outlook on Anavex Life Sciences' clinical progress and potential in developing treatments for neurological disorders. The share price at the time of the report of US$5.51 represents a potential return of approximately 626% to the analyst's target price, highlighting the significant upside potential if the company's clinical development plans prove successful.

Important Disclosures:

1. This article does not constitute investment advice and is not a solicitation for any 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. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
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.

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Disclosures for H.C. Wainwright & Co., Anavex Life Sciences Corp., October 18, 2024.

This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules. If you have received it by mistake, please let us know by e-mail reply to unsubscribe@hcwresearch.com and delete it from your system; you may not copy this message or disclose its contents to anyone. The integrity and security of this message cannot be guaranteed on the Internet. H.C. WAINWRIGHT & CO, LLC RATING SYSTEM: H.C. Wainwright employs a three tier rating system for evaluating both the potential return and risk associated with owning common equity shares of rated firms. The expected return of any given equity is measured on a RELATIVE basis of other companies in the same sector. The price objective is calculated to estimate the potential movements in price that a given equity could reach provided certain targets are met over a defined time horizon. Price objectives are subject to external factors including industry events and market volatility.

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Raghuram Selvaraju, Ph.D. , 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 Anavex Life Sciences Corp. (including, without limitation, any option, right, warrant, future, long or short position). As of September 30, 2024 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Anavex Life Sciences Corp.. 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. Mr. Selvaraju, who is [the][an] author of this report, is the Chairman of and receives compensation from Relief Therapeutics Holding SA, a Swiss, commercial-stage biopharmaceutical company identifying, developing and commercializing novel, patent protected products in selected specialty, rare and ultra-rare disease areas on a global basis ("Relief"). You should consider Mr. Selvaraju's position with Relief when reading this research report. The firm or its affiliates received compensation from Anavex Life Sciences Corp. for non-investment banking services in the previous 12 months. The Firm or its affiliates did not receive compensation from Anavex Life Sciences Corp. 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 does not make a market in Anavex Life Sciences Corp. 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. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request. 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.

( Companies Mentioned: AVXL:NASDAQ, )

Source: Ron Struthers 10/22/2024

Silver is up again today, currently $34.72 up about $0.64.

This confirms yesterdays breakout and if you remember back in April or early May, I highlighted the breakout from a cup and handle formation and that would lead to a major upside move. This is not confirmed and I see $50 as the near term target.

Similar to gold, investor participation is still quite low. Volumes into the silver etf SLF are up some but no where near 2020 volumes. There are all kinds of silver bullion available at the coin dealer I use.

Our silver stocks are not dragging down the average performance of our gold stocks as much now, and I would like to add another one to the list.

Coeur Mining

_{Shares Outstanding - 399 million}

Coeur Mining Inc. (CDE:NYSE) has been a laggard in this bull rally thus far because it is not well understood. Investors seem to remember more of their legacy than who they are today. Many investors know Coeur as a silver company, but for many years now, most of their revenue and profits have come from gold. Around $7.20, the stock is well below its 2021 highs of around $11.50 and 2016 highs of $16

In Q2 2024, gold sales were $154.1 million, and silver sales were $67.9 million. This makes gold sales almost 70% of revenues. The stock should have responded more to the rising gold price, but as I said, I think investors were still viewing Coeur as mostly a silver company.

That said, they do have large leverage to silver because their resource base they are almost 60% silver. The company is maintaining its full-year production guidance ranges of 310,000 - 355,000 gold ounces and 10.7 - 13.3 million silver ounces. Full-year CAS guidance at Palmarejo and Wharf has been reduced to reflect strong cost management efforts, while Rochester's second-half CAS guidance ranges have been increased to reflect the timing of ounces placed under leach.

Other significant news on the silver front was just a couple of weeks ago, on October 4. Coeeur announced that they entered into a definitive agreement to acquire all of the issued and outstanding shares of SilverCrest pursuant to a court-approved plan of arrangement.

Under the terms of the Agreement, SilverCrest shareholders will receive 1.6022 Coeur common shares for each SilverCrest common share. The Exchange Ratio implies a consideration of $11.34 per SilverCrest common share, based on the closing price of Coeur common shares on the New York Stock Exchange ("NYSE") on October 3, 2024. This represents an 18% premium based on 20-day volume-weighted average prices of Coeur and SilverCrest each as of October 3, 2024.

It turns out, this was a very well timed acquisition ahead of the silver price rise and it will make Coeur the world's largest pure silver producer at about 21 million ounces per year. Their silver production should be neck and neck or just a little behind Pan American Silver not shown on this graphic.

Another key positive fundamental is the expansion of their Rochester Mine this year. In mid-September, they announced that the new three-stage crushing circuit continues to deliver greatly enhanced levels of flexibility to accommodate the full range of mined ore in Rochester.

For the month of August, approximately 2.7 million tons were placed on the new Stage VI leach pad, representing a 39% increase over July placement levels. Rochester remains on track to place 7.0 – 8.0 million tons per quarter during the second half of 2024 and to achieve its full-year 2024 production guidance of 4.8 – 6.6 million ounces of silver and 37,000 – 50,000 ounces of gold.

Rochester is the largest open pit heap leach operation in North America and the largest silver reserve asset in the U.S.

At the end of 2023, Coeur had 3.2 million ounces of proven and probable gold reserves and 243.9 million ounces of silver. At the long-term reference of 60 to 1 ratio, their reserves are 58% silver and 42% gold.

With the significant expansion at Rochester and the acquisition of SilverCrest it will make a significant positive effect to increased profits and cash flow. According to Coeur's presentation, using Factset Street Research data, they will be the leader among peers. The Pro Forma adding SilverCrest is significant. The higher silver price is more gravy on top.

The chart looks good, too. Volume is picking up, and it looks like the stock will break through the resistance area and head to $11.

You can get some more leverage with Call options. Because this is a low-priced stock, I would take advantage of low premiums on long dates. The December 2025 $5.50 Call option is about $2.75 and is $1.87 in the money, so a premium of less than $1.00 for almost 14 months. Nektar Therapeutics (NKTR:NASDAQ)

Nektar Therapeutics

_{Recent Price - $1.41}

_{Entry Price- $0.68}

_{Opinion - Sell}

There is nothing wrong with Nektar Therapeutics (NKTR:NASDAQ), but I am concerned we could get a significant market correction, and I don't like the fact the stock has not done better in a bullish market.

That said, I think this reflects how concentrated this bull market is and does not have good breadth.

The stock is just below cash value but the stock is near resistance on the chart and besides that we have over 100% profits in about 8 months, lets take them.

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Important Disclosures:

1. Ron Struthers: I or members of my immediate household or family, own securities of: Couer Mining. I determined which companies would be included in this article based on my research and understanding of the sector.
2. Statements and opinions expressed are the opinions of the author and not of Streetwise Reports, Street Smart, or their officers. The author is wholly responsible for the accuracy of the statements. 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. Any disclosures from the author can be found below. Streetwise Reports relies upon the authors to accurately provide this information and Streetwise Reports has no means of verifying its accuracy.
3. This article does not constitute investment advice and is not a solicitation for any 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. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
4. 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.

Struthers Resource Stock Report Disclosures

All forecasts and recommendations are based on opinion. Markets change direction with consensus beliefs, which may change at any time and without notice. The author/publisher of this publication has taken every precaution to provide the most accurate information possible. The information & data were obtained from sources believed to be reliable, but because the information & data source are beyond the author's control, no representation or guarantee is made that it is complete or accurate. The reader accepts information on the condition that errors or omissions shall not be made the basis for any claim, demand or cause for action. Because of the ever-changing nature of information & statistics the author/publisher strongly encourages the reader to communicate directly with the company and/or with their personal investment adviser to obtain up to date information. Past results are not necessarily indicative of future results. Any statements non-factual in nature constitute only current opinions, which are subject to change. The author/publisher may or may not have a position in the securities and/or options relating thereto, & may make purchases and/or sales of these securities relating thereto from time to time in the open market or otherwise. Neither the information, nor opinions expressed, shall be construed as a solicitation to buy or sell any stock, futures or options contract mentioned herein. The author/publisher of this letter is not a qualified financial adviser & is not acting as such in this publication.

( Companies Mentioned: CDE:NYSE, NKTR:NASDAQ, )

Source: Andrew Fein 10/23/2024

H.C. Wainwright & Co. analysts Andrew S. Fein, Matthew Caufield, Dr. Andres Y. Maldonado, and Dr. Ananda Ghosh, in a research report published on October 23, 2024, maintained a Buy rating on DBV Technologies SA (DBVT:NASDAQ) while raising their price target to US$7.00 from US$5.00. The report follows DBV's announcement of regulatory clarity regarding the path forward for its Viaskin Peanut patch.

The analysts highlighted the significance of the FDA agreement, stating, "DBV Technologies has reached an agreement with the FDA regarding the regulatory pathway for the Viaskin Peanut patch in toddlers aged one to three, under the Accelerated Approval pathway."

Regarding the company's development timeline, the analysts noted, "The Biologics License Application (BLA) submission for Viaskin Peanut in this age group is expected to be supported by positive efficacy and safety data from DBV's completed EPITOPE Phase 3 study, as well as additional safety data from the upcoming six-month COMFORT Toddlers supplemental safety study, which is expected to begin in 2Q25."

The report emphasized the strength of DBV's regulatory position, stating, "The FDA has stated that DBV has already satisfied two of the three criteria: the product treats a serious condition, and the product candidate provides a meaningful advantage over available therapies."

The analysts also highlighted progress in Europe, noting, "The EMA confirmed that the successfully completed EPITOPE Phase 3 efficacy and safety trial in the one to three-year-old population, along with positive results from the VITESSE study in the four to seven-year-old population, and a new safety study using the modified circular patch in one to three-year-olds, could support an MAA for the one to seven-year-old indication with the modified patch."

The analysts' valuation methodology for DBV Technologies is based on a composite approach. They explained, "Our US$7 price target is based on an equally weighted composite of: (a) US$5.10/share, as a 20x multiple of taxed and diluted FY34 GAAP EPS of US$5.13 discounted back to FY24 at 35%; and (b) an NPV of US$8.52/share with a 13% discount rate and 1% growth rate."

The report included commercial projections, with the analysts stating, "We continue to model initial approval in 2027, with projected initial sales of US$17.5M, growing to US$1,182.8M by 2034."

The analysts also outlined several risk factors, including potential clinical study failures, regulatory approval challenges, and market size uncertainties.

In conclusion, H.C. Wainwright & Co.'s increased price target to US$7 reflects growing confidence in DBV Technologies' regulatory pathway for the Viaskin Peanut patch. The share price at the time of the report of US$0.70 represents a potential return of approximately 900% to the analysts' target price, highlighting the significant upside potential if the company successfully navigates the regulatory process and commercializes its product.

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Important Disclosures:

1. This article does not constitute investment advice and is not a solicitation for any 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. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
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.

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Disclosures for H.C. Wainwright & Co. DBV Technologies S.A., October 23, 2024

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H.C. WAINWRIGHT & CO, LLC RATING SYSTEM: H.C. Wainwright employs a three tier rating system for evaluating both the potential return and risk associated with owning common equity shares of rated firms. The expected return of any given equity is measured on a RELATIVE basis of other companies in the same sector. The price objective is calculated to estimate the potential movements in price that a given equity could reach provided certain targets are met over a defined time horizon. Price objectives are subject to external factors including industry events and market volatility.

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Andrew S. Fein, Matthew Caufield, Andres Y. Maldonado, PhD and Ananda Ghosh, PhD , 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 DBV Technologies S.A. (including, without limitation, any option, right, warrant, future, long or short position). As of September 30, 2024 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of DBV Technologies S.A.

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 received compensation from DBV Technologies S.A. for non-investment banking services in the previous 12 months. The Firm or its affiliates did not receive compensation from DBV Technologies S.A. 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 does not make a market in DBV Technologies S.A. as of the date of this research report.

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( Companies Mentioned: DBVT:NASDAQ, )

Source: Streetwise Reports 10/28/2024

Sernova Corp. (SVA:TSX.V; SEOVF:OTCQB; PSH:XERTA) and its Cell Pouch technology could be the solution to existing challenges involving the delivery of medical treatments to patients, such as the ones described here.

Diabetic patients in resource-limited settings are having to revert back to one of the less favored, alternative ways to take insulin, via syringes or glass vials, because Danish pharmaceutical company, Novo Nordisk A/S (NVO:NYSE), will stop making its insulin pens, The Guardian reported. Patients generally prefer this method for dosing themselves with insulin, as shown in a 2024 survey, because it is more convenient and more accurate.

Type 1 diabetic patients already are being impacted as Novo stopped supplying its insulin pens to certain regions, South Africa for instance. Patients there have switched back to using glass vials.

In a second situation, Novo Nordisk is working to bring stem cell-based therapies to patients more efficiently and, in seeking a solution, formed a partnership with Evotec SE (EVO:NASDAQ) to develop technologies that will achieve this, noted Evotec is a Germany-based global biotech firm with its own cell therapy and partnered cell types all in preclinical development for various indications, including diabetes, oncology, cardiology, and ophthalmology.

Per the agreement, Novo Nordisk is to provide research and development funding and potentially monetary incentives to Evotec, and Evotec is to develop the desired new technologies. Novo has the option to obtain exclusive rights to use, in a predefined medical indication, the product(s) born out of this collaboration agreement. Novo's areas of focus, along with diabetes, are cardiovascular diseases, rare diseases, growth hormone-related diseases, hemophilia, nonalcoholic steatohepatitis, and weight management.

Safe, Effective Therapeutic Cell Delivery

Sernova Corp.'s Cell Pouch is a vehicle for delivering various types of therapeutic cells to patients, such as donor islet cells to insulin-dependent diabetics.

When used, the Cell Pouch's containment channels are filled with the appropriate therapeutic cells, and then the device is implanted in the patient. In situ, the cells release therapeutic proteins or hormones the patient's body completely or partially lacks. The device creates a vascularized, organ-like environment that protects the therapeutic cells from immune system attacks, keeping them alive and functioning.

"The Cell Pouch is the most advanced encapsulation device in development," Ventum Capital Markets Analyst Stefan Quenneville wrote in a Sept. 12 research report.

Sernova is testing its Cell Pouch in the clinic, specifically in Type 1 diabetes. In its ongoing Phase 1/2 study, the Canadian company is evaluating the treatment of insulin-dependent diabetes with donor islets implanted via the Cell Pouch, with added immunosuppression therapy. Study data so far have shown the Cell Pouch to be safe and well tolerated and the treatment, effective, reported Dr. Joseph Pantginis, analyst at H.C. Wainwright & Co., in a Sept. 12 research report.

Seven patients, all six of Cohort A and one in Cohort B, achieved sustained insulin independence, between 5.5 and 50 months in duration, free of hypoglycemic episodes. Their blood sugar levels were controlled in the nondiabetic range (i.e.,) HbA1c less than 6.5%.

"The Cell Pouch is the most advanced encapsulation device in development," Ventum Capital Markets Analyst Stefan Quenneville wrote.

A Cell Pouch removed from one of the study patients showed it still contained functioning insulin, glucagon, and somatostatin-producing cells. No evidence was seen of detrimental fibrotic tissue, too many T-cells, material degradation, or changes in the device architecture.

"We believe the impressive response rates and observed durability support Sernova's strategy and justify further investigation while positioning the technology for potential commercial success," noted Pantginis.

The results add to an expanding collection of evidence that the Cell Pouch is functioning as it should. The data also support the "impressive" results already reported from this study and help derisk future related trials.

"If Sernova is successful in bringing its functional cure for insulin-dependent diabetes to the stage where it can go into commercial production, the global market for it will be massive," wrote Technical Analyst Clive Maund in a Sept. 16 note.

In another of its programs, Sernova, in collaboration with Evotec, is developing an implantable off-the-shelf, induced pluripotent stem cell (iPSC)-based islet replacement therapy, Maund reported.

"This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (Type 1 and Type 2)," he added.

This partnership was announced on May 17, 2022. You can read more about it in the press release here.

Market Growth Predicted to 2030

The global live cell encapsulation market, encompassing drug delivery, regenerative medicine and cell transplantation, is expected to continue growing through at least 2030, according to Grand View Research. The market's value, US$210.7 million in 2022, is forecasted to increase at a 3.97% compound annual growth rate between that year and 2030.

"If Sernova is successful in bringing its functional cure for insulin-dependent diabetes to the stage where it can go into commercial production, the global market for it will be massive," wrote Technical Analyst Clive Maund.

Along with diabetes, live cell encapsulation is being used to treat neurological disorders like Parkinson's disease, The market research firm noted. Further, it has been proven to be a suitable way to deliver treatment for other types of diseases, including cancer, anemia, heart failure and more.

Several factors are expected to keep driving market growth during the forecast period, Grand View noted. A significant one is the increasing use of live cell encapsulation in regenerative medicine to replace disease or damaged tissues. A related contributor is rising public and private funding and investments in cell and gene therapies.

The advantages of live cell encapsulation in controlled drug delivery are boosting the market, too. They include enhanced therapeutic effects, lowered drug dose, reduced cytotoxicity, improved patient convenience and better patient compliance.

Novel new products and technological advancements are expected to add value to the market as well.

The Catalysts: Progress With Programs

Various potential stock-moving events are slated for Sernova, according to its September 2024 Corporate Presentation.

Two catalysts are expected by Sernova in 2025, related to the company's ongoing Phase 1/2 clinical trial in Type 1 diabetes. One is results for the remaining Cohort B patients. The other is commencement of Cohort C, who will receive, along with the islet cells, an optimized immune suppression regimen.

Several analysts are bullish on Sernova. One of them is Loe, who rates it as a Speculative Buy. His price target on the life sciences firm implies a 455% return from its current share price.

Next year, Sernova plans to start a Phase 1/2 trial of the regeneratively produced islet cells to result from its partnership with Evotec, delivered via the Cell Pouch to Type 1 diabetes patients.

Other catalysts are expected to come as a result of Sernova advancing its preclinical programs. One is a personalized treatment with patient corrected cells via Cell Pouch for hypothyroidism. Another is a Cell Pouch-delivered, ex vivo lentiviral factor VIII gene therapy for hemophilia, being developed in partnership with the European Haemacure Consortium.

Also, through partnerships, Sernova is developing technologies that would eliminate the need for concurrent immunosuppression during Cell Pouch-delivered cell treatment, a "blue sky objective," Douglas Loe, a Leede Financial Inc. analyst, noted in a Sept. 12 research report.

"Any advances in this regard could be incorporated into future Cell Pouch studies," he wrote. "We do not consider the need for such therapy to be relevant to Cell Pouch function itself."

Analyst: Company is "Very Undervalued"

Several analysts are bullish on Sernova. One of them is Loe, who rates it as a Speculative Buy. His price target on the life sciences firm implies a 455% return from its current share price.

According to H.C. Wainwright's Pantginis, the deepening responses of Type 1 diabetes patients in its Phase 1/2 trial continue to "crystallize Sernova stock's possible upside." The upside reflected in Pantginis' price target is 2,122%. The analyst recommends the company as a Buy.

Ventum's Quenneville also has a Buy on Sernova, and his target price reflects an 826% return on investment. In his report, the analyst highlighted the impressive efficacy and tolerability of the Cell Pouch up to five years post-implantation, as shown in the Phase 1/2 clinical trial data.

"This represents the longest-lasting implanted encapsulation device containing functioning islets without fibrosis," Quenneville wrote.

According to Technical Analyst Maund, Sernova is "very undervalued here given its huge potential" in the Type 1 diabetes market, as indicated on the stock charts. The fundamental outlook for the company is improving, and evidence is strong that a reversal to the upside may be happening. SVA may appreciate significantly soon. [OWNERSHIP_CHART-4790]

"Sernova is therefore viewed as a good stock to accumulate in this area, between the current price and recent lows," Maund wrote on Sept. 16. At that time, Sernova's share price was about the same as it is now.

Ownership and Share Structure

According to Refinitiv, about 12.96% of the company is held by insiders and management, and 0.05% by institutions. The rest is retail.

Top shareholders include Tomas Angel with 4.91%, Director Steven Sangha with 4.27%, Betty Anne Millar with 1.32%, Brett Alexander Whalen with 0.87%, and Garry Deol with 0.77%.

Its market cap is CA$83 M. Its 52-week range is CA$0.20−0.82 per share.

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Important Disclosures:

1. Sernova Corp. has a consulting relationship with Street Smart an affiliate of Streetwise Reports. Street Smart Clients pay a monthly consulting fee between US$8,000 and US$20,000.
2. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Sernova Corp.
3. Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor.
4. 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. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
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.

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( Companies Mentioned: SVA:TSX.V;SEOVF:OTCQB;PSH:XERTA, )

Source: Dr. Douglas Loe 10/31/2024

Leede Financial analysts Dr. Douglas Loe and Siew Ching Yeo, in a research report published on October 30, 2024, maintained their Speculative Buy rating on ProMIS Neurosciences Inc. (PMN:TSX; PMN:NCM) with a price target of US$9.50. The report follows ProMIS's presentation of interim Phase I data for PMN310, its Alzheimer's disease (AD) candidate, at the Clinical Trials on Alzheimer's Disease (CTAD) conference.

The analysts highlighted the positive safety and pharmacokinetic (PK) data, stating, "We were encouraged (though not overly surprised) to see that the mAb was well-tolerated at all five test doses ranging from 2.5mg/kg-to-40mg/kg." They added, "PK analysis of all of these patient cohorts in this single-ascending dose (SAD) trial suggests that once-monthly dosing may be sufficient to sustain mAb levels both in plasma and in cerebrospinal fluid over time."

Regarding dosing efficacy, the analysts noted, "Importantly, ProMIS indicated in the Jul/24 update that even at 2.5mg/kg dosing, PMN310 levels in CSF were over 100x higher than predicted to be necessary to bind to all beta-amyloid oligomers that could accumulate in CSF in diseased patients."

The analysts emphasized the significance of recent industry developments, particularly AbbVie's acquisition of Aliada Therapeutics, stating, "AbbVie's tangible interest in Phase I-stage AD assets shows us that ProMIS could itself be attractive to future suitors if/when it can document direct impact on cognitive impairment in diseased patients."

The report highlighted ProMIS's financial position following its recent equity offering, noting that the company raised US$30.3M with multiple layers of warrant coverage tied to development milestones.

Leede Financial's valuation methodology combines multiple approaches. The analysts explained, "We are maintaining our Speculative Buy rating and one-year PT of US$9.50 on PMN, with our valuation still based on NPV (30% discount rate) and multiples of our F2029 EBITDA/fd EPS forecasts."

They added, "By direct comparison to Aliada's US$1.4B value, PMN shares would notionally be valued on a fully-diluted basis at US$17.65/shr."

In conclusion, Leede Financial's maintenance of their Speculative Buy rating and US$9.50 price target reflects confidence in ProMIS's development of PMN310 and its potential in the Alzheimer's disease market. The share price at the time of the report of US$1.03 represents a potential return of approximately 822% to the analysts' target price, highlighting the significant upside potential if the company's clinical development plans prove successful.

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1. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of ProMIS Neurosciences Inc.
2. This article does not constitute investment advice and is not a solicitation for any 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. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
3. 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.

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Disclosures for Leede Financial Inc., ProMIS Neurosciences Inc., October 30, 2024

Important Information and Legal Disclaimers Leede Financial Inc. (Leede) is a member of the Canadian Investment Regulatory Organization (CIRO) and a member of the Canadian Investor Protection Fund (CIPF). This document is not an offer to buy or sell or a solicitation of an offer to buy or sell any security or instrument or to participate in any particular investing strategy. Data from various sources were used in the preparation of these documents; the information is believed but in no way warranted to be reliable, accurate and appropriate. All information is as of the date of publication and is subject to change without notice. Any opinions or recommendations expressed herein do not necessarily reflect those of Leede. Leede cannot accept any trading instructions via e-mail as the timely receipt of e-mail messages, or their integrity over the Internet, cannot be guaranteed. Dividend yields change as stock prices change, and companies may change or cancel dividend payments in the future. All securities involve varying amounts of risk, and their values will fluctuate, and the fluctuation of foreign currency exchange rates will also impact your investment returns if measured in Canadian Dollars. Past performance does not guarantee future returns, investments may increase or decrease in value, and you may lose money. Leede employees may buy and sell shares of the companies that are recommended for their own accounts and for the accounts of other clients. Disclosure codes are used in accordance with Policy 3600 of CIRO.

Description of Disclosure Codes 1. Leede and its affiliates collectively beneficially own 1% or more of any class of equity securities of the company as of the end of the preceding month or the month prior to the preceding month if the report was issued prior to the 10th. 2. The analyst or any associate of the analyst responsible for the report or public comment hold shares or is short any of the company's securities directly or through derivatives. 3. Leede or a director or officer of Leede or any analyst provided services to the company for remuneration other than normal investment advisory or trade execution services within the preceding 12 months. 4. Leede provided investment banking services for the company during the 12 months preceding the publication of the research report. 5. Leede expects to receive or intends to seek compensation for investment banking services in the next three months. 6. The analyst preparing the report received compensation based upon Leede investment banking revenues for this issuer within the preceding 12 months. 7. The director, officer, employee, or research analyst is an officer, director or employee of the company, or serves in an advisory capacity to the company. 8. Leede acts as a market maker of the company. 9. The analyst has conducted a site visit and has viewed a major facility or operation of the issuer. 10. The company has paid for all, or a material portion, of the travel costs associated with the site visit by the analyst.

Dissemination All final research reports are disseminated to existing and potential institutional clients of Leede Financial Inc. (Leede) in electronic form to intended recipients thorough e-mail and third-party aggregators. Research reports are posted to the Leede website and are accessible to customers who are entitled to the firm’s research. Reproduction of this report in whole or in part without permission is prohibited.

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Canadian Disclosures This research has been approved by Leede Financial Inc. (Leede), which accepts sole responsibility for this research and its dissemination in Canada. Leede is registered and regulated by the Canadian Investment Regulatory Organization (CIRO) and is a member of the Canadian Investor Protection Fund (CIPF). Canadian clients wishing to effect transactions in any designated investment discussed should do so through a Leede Registered Representative.

U.S. Disclosures This research report was prepared by Leede Financial Inc. (Leede). Leede is registered and regulated by the Canadian Investment Regulatory Organization (CIRO) and is a member of the Canadian Investor Protection Fund (CIPF). This report does not constitute an offer to sell or the solicitation of an offer to buy any of the securities discussed herein. Leede is not registered as a broker-dealer in the United States and is not subject to U.S. rules regarding the preparation of research reports and the independence of research analysts. Any resulting transactions should be effected through a U.S. broker-dealer.

( Companies Mentioned: PMN:TSX; PMN:NCM, )

Source: Streetwise Reports 11/05/2024

Treatment.com AI Inc. (TRUE:CSE; TREIF:OTCMKTS; 939:FRA) has announced the release of its newly updated Medical Education Suite (MES). This release aligns with the company's active participation in a major symposium focused on AI assessment in medical education. The Symposium, hosted by the University of Minnesota Medical School,  drew thought leaders and representatives from over 50 medical schools and national education organizations across the United States and internationally.

The updated MES has been designed to leverage Treatment's proprietary Global Library of Medicine (GLM) to help reduce the administration overhead and associated time and costs for medical schools in running key exams, such as the Objective Structured Clinical Examination (OSCE). Additionally, this updated version of the MES includes "easy to use" features to further support students in their clinical assessment training and exam preparation. This OSCE exam is seen as a critical evaluation used globally to assess the practical skills of medical students. It is now employed in more than 80 countries, with between 200,000 to 300,000 students participating annually.¹

The MES incorporates various AI-driven features, such as automated case generation for OSCE exams, scripts for simulated patients, and instant scoring with personalized feedback. The Suite also introduces new tools, including AI Patient, which supports students preparing for medical exams, and expanded OSCE case packages, which are expected to grow to a library of 100 cases by the end of Q4 2024. Additionally, the AI Prep Tool offers both non-guided and guided exam-simulated modes, assisting students in honing their clinical reasoning.

Kevin Peterson, MD, MPH, Treatment's Chief Medical Officer, delivered a keynote at the Symposium, joining an impressive lineup that includes presenters from Mayo Clinic and the University of Alberta. The company highlights that this Symposium is a crucial opportunity to demonstrate its MES and showcase its growing influence in the field of medical education.

CEO Dr. Essam Hamza emphasized the significance of this event, stating in the press release, "We are excited to showcase our updated medical education software suite at this landmark Symposium. The opportunity to have a positive impact on the medical training of students and, in turn, introduce them to our range of proprietary AI tools is an important inflection point in the company's commercialization timeline."

AI in Healthcare

On October 10, Microsoft emphasized the importance of multimodal AI models for a comprehensive assessment of patient health. The report highlighted the growing importance of using AI to analyze complex, multimodal health data, such as medical imaging, genomics, and clinical records. The integration of these data sources has enabled more precise diagnostics and treatment planning, illustrating the sector's move toward comprehensive AI applications. The healthcare industry has faced challenges like the need for large-scale, integrated datasets and significant computational resources, but advancements have begun to bridge these gaps. Microsoft noted that these developments would help unlock new insights and improve patient care by accelerating innovation and enhancing clinical decision-making across the sector.

On November 4, Forbes reported that AI-powered healthcare tools were no longer merely experimental but were instead delivering real value across the industry. Examples included enhanced diagnostic accuracy through AI algorithms, like those developed by Google Cloud Healthcare, and improved administrative processes through platforms like Cedar's AI-powered billing system. Forbes noted that these developments were reshaping patient care and reducing administrative burdens, offering measurable benefits.

Also, on November 4, Tech Target highlighted the optimism among healthcare professionals regarding generative AI's potential to alleviate administrative burdens. Over 90% of healthcare workers surveyed expressed confidence in generative AI's ability to simplify tasks like prior authorizations and nurse handoff reports. Aashima Gupta from Google Cloud shared insights on these tools' transformative capabilities, while Tony Farah from Highmark Health cited an 85% reduction in provider administrative costs after automating prior authorizations. Helen Waters from Meditech added, "We believe that gen AI and AI overall is transforming how healthcare professionals access and use information to make powerful decisions confidently," reflecting the positive impact of AI tools on healthcare workflows and decision-making.

Company Catalysts

Treatment.com AI Inc. continues to evolve its medical education platform, incorporating advanced AI technologies that could help revolutionize medical education and training. The company is leveraging its Global Library of Medicine, which offers over 10,000 medical reviews and covers more than 1,000 diseases and associated symptoms. These AI-driven tools aim to enhance clinical decision-making while reducing administrative burdens for healthcare institutions.

The updated MES is projected to impact medical training through its comprehensive and AI-enhanced features, as outlined in Treatment's investor presentation. The presentation details the significant market potential, with the AI healthcare market expected to grow from US$11 billion in 2021 to US$187 billion by 2030, according to Statista. In addition to Treatment's announced new functionality, the company has already begun work on further solutions such as AI Doctor in a Pocket and audio/video analysis tools for clinical scoring and diagnostics. The goal of this expanded portfolio is to position the company to help expedite its aggressive growth plans over the next year.

Analysis of Treatment.com AI

Ownership and Share Structure

According to Sedi.ca, insiders own approximately 8% of Treatment.com AI. Retail investors own the remaining 92%. 

The company has 48.99 million outstanding common shares and has 41.3 million free float traded shares.

As of November 4, the market cap is approximately CA$31.35 million. Over the past 52 weeks, the company traded between CA$0.355 and CA$1.11 per share.

¹Source bodies including: https://www.aamc.org/; https://www.uems.eu/; https://www.nmc.org.in/; Education – GMC (gmc-uk.org)

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Important Disclosures:

1. Treatment.com AI has a consulting relationship with Street Smart an affiliate of Streetwise Reports. Street Smart Clients pay a monthly consulting fee between US$8,000 and US$20,000.
2. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Treatment.com AI.
3. James Guttman wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee.
4. This article does not constitute investment advice and is not a solicitation for any 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. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
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.

For additional disclosures, please click here.

* Disclosure for the quote from the Clive Maund article published on [Date]

1. For the quoted article (published on [Date]), the Company has paid Street Smart, an affiliate of Streetwise Reports, between US$1,500 and US$2,500.
2. Author Certification and Compensation: [Clive Maund of clivemaund.com] is being compensated as an independent contractor by Street Smart, an affiliate of Streetwise Reports, for writing the article quoted. Maund received his UK Technical Analysts’ Diploma in 1989. The recommendations and opinions expressed in the article accurately reflect the personal, independent, and objective views of the author regarding any and all of the designated securities discussed. No part of the compensation received by the author was, is, or will be directly or indirectly related to the specific recommendations or views expressed

Clivemaund.com Disclosures

The quoted article 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. 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 cannot be only be construed as a recommendation or solicitation to buy and sell securities.

¹Source bodies including: https://www.aamc.org/; https://www.uems.eu/; https://www.nmc.org.in/; Education – GMC (gmc-uk.org)

( Companies Mentioned: TRUE:CSE; TREIF:OTCMKTS;939:FRA, )

Source: Dr. Joseph Pantginis 11/04/2024

H.C. Wainwright & Co. analysts Dr. Joseph Pantginis, Dr. Lander Egaña Gorroño, Dr. Joshua Korsen, Dr. Matthew Keller, and Dr. Sara Nik, in a research report published on November 4, 2024, maintained their Buy rating on Lexicon Pharmaceuticals Inc. (LXRX:NASDAQ) with a price target of US$6.00. The report follows Lexicon's presentation of preclinical data for LX9851, its ACSL5 inhibitor for obesity, at ObesityWeek 2024.

The analysts highlighted key findings from the presentations, stating, "LX9851 promotes reduction of fat mass without affecting lean body mass" and "LX9851 improves and sustains GLP-1 RA-mediated weight loss, even after semaglutide discontinuation." They added that "Mechanistic studies suggest that LX9851-mediated ACSL5 inhibition activates the ileal brake."

Regarding the drug's potential, they noted, "LX9851 is a first-in-class, oral small molecule ACSL5 inhibitor designed to enhance and maintain weight loss promoted by incretin mimetics (GLP-1 receptor agonists), and offer improved treatment alternatives for obesity and related metabolic disorders."

The report also addressed recent developments with sotagliflozin, detailing the AdCom voting results and potential scenarios for FDA action. The analysts stated, "Although we anticipate favorable feedback from the agency regarding eGFR ≥60 to <90 range, our bet is that a confirmatory trial may be required to validate sota's efficacy in this subpopulation and obtain approval."

H.C. Wainwright & Co.'s valuation methodology is based on a clinical net present value (NPV) model. The analysts explained, "Our valuation is based on our clinical net present value (NPV) model, which allows us to flex multiple assumptions affecting a drug's profile. We currently value Lexicon solely on sotagliflozin sales in the U.S. for HF (INPEFA), HCM, and LX9211 for DPNP."

They added, "We believe significant upside potential exists, based on: (1) attaining higher market penetration for HF, and HCM; and (2) adding the earlier stage assets."

In conclusion, H.C. Wainwright & Co.'s maintenance of their Buy rating and US$6 price target reflects confidence in Lexicon's pipeline potential, particularly with LX9851 and sotagliflozin. The share price at the time of the report of US$1.22 represents a potential return of approximately 392% to the analysts' target price, highlighting the significant upside potential if the company's development programs prove successful.

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1. This article does not constitute investment advice and is not a solicitation for any 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. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
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.

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Disclosures for H.C. Wainwright & Co., Lexicon Pharmaceuticals Inc., November 4, 2024

This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules. If you have received it by mistake, please let us know by e-mail reply to unsubscribe@hcwresearch.com and delete it from your system; you may not copy this message or disclose its contents to anyone. The integrity and security of this message cannot be guaranteed on the Internet. H.C. WAINWRIGHT & CO, LLC RATING SYSTEM: H.C. Wainwright employs a three tier rating system for evaluating both the potential return and risk associated with owning common equity shares of rated firms. The expected return of any given equity is measured on a RELATIVE basis of other companies in the same sector. The price objective is calculated to estimate the potential movements in price that a given equity could reach provided certain targets are met over a defined time horizon. Price objectives are subject to external factors including industry events and market volatility.

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Joseph Pantginis, Ph.D., Lander Egaña Gorroño, Ph.D., Joshua Korsen, Ph.D., Matthew Keller, Ph.D. and Sara Nik, Ph.D. , 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 Lexicon Pharmaceuticals, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of September 30, 2024 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Lexicon Pharmaceuticals, Inc..

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 received compensation from Lexicon Pharmaceuticals, Inc. for non-investment banking services in the previous 12 months. The Firm or its affiliates did not receive compensation from Lexicon Pharmaceuticals, Inc. 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 does not make a market in Lexicon Pharmaceuticals, Inc. 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. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request. 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.

( Companies Mentioned: LXRX:NASDAQ, )

Source: Dr. Douglas Loe 11/05/2024

Leede Financial Inc. analyst Dr. Douglas Loe, in a research report published on November 4, 2024, maintained a Buy rating on Profound Medical Corp. (PROF:NASDAQ; PRN:TSX) with a price target of US$18.00. The report follows Profound's announcement that its TULSA-PRO device will receive a Category One CPT code from the U.S. Centers for Medicare & Medicaid Services (CMS).

Loe highlighted the significance of the reimbursement update, stating, "We have long viewed device-specific U.S. reimbursement codes for TULSA-PRO to be integral to its broader adoption in urology/oncology markets, and today's update thus solidifies TULSA-PRO's status on that theme."

The analyst emphasized the favorable reimbursement rates, noting, "Hospitals/ASCs will be reimbursed at the Medicare average of US$12,992/US$10,728 per procedure. This is sufficient economic incentive in our view to drive TULSA-PRO installed base and procedure volume growth in F2025 and thereafter."

Regarding growth projections, Loe stated, "Our model assumes that consolidated revenue/EBITDA/EPS in F2025 of US$34.9M/(US$3.9M)/(US$0.20/shr), but then lifting substantially on all metrics to US$59.1M/US$14.7M/US$0.10/shr in F2026 and then to US$95.5M/US$38.1M/US$1.05/shr in F2027."

The report highlighted potential strategic interest, with Loe noting, "We expect urology-focused suitors to show tangible interest in Profound as the annual top-line performance approaches US$100M on a run-rate basis, which our model projects by FH227."

Leede Financial's valuation methodology combines multiple approaches. Loe explained, "Our valuation still based on NPV (20% discount rate) and multiples of our F2027 EBITDA/fd EPS forecasts (US$38.1M & US$1.05/shr, respectively), with our EV calculation incorporating FQ224 balance sheet data (cash of US$34.1M, total debt of US$6.0M) and fully-diluted S/O of 26.0M."

The analyst also noted that while F2024 is a transition year, F2025 is expected to be transformative for U.S. TULSA-PRO adoption rates.

In conclusion, Leede Financial's maintenance of its Buy rating and US$18 price target reflects confidence in Profound Medical's growth potential following the favorable reimbursement update. The share price at the time of the report of US$7.35 represents a potential return of approximately 145% to the analyst's target price, highlighting the significant upside potential as the company advances its commercialization efforts.

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1. This article does not constitute investment advice and is not a solicitation for any 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. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
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Disclosures for Leede Financial Inc., Profound Medical Corp., November 4, 2024

Important Information and Legal Disclaimers Leede Financial Inc. (Leede) is a member of the Canadian Investment Regulatory Organization (CIRO) and a member of the Canadian Investor Protection Fund (CIPF). This document is not an offer to buy or sell or a solicitation of an offer to buy or sell any security or instrument or to participate in any particular investing strategy. Data from various sources were used in the preparation of these documents; the information is believed but in no way warranted to be reliable, accurate and appropriate. All information is as of the date of publication and is subject to change without notice. Any opinions or recommendations expressed herein do not necessarily reflect those of Leede. Leede cannot accept any trading instructions via e-mail as the timely receipt of e-mail messages, or their integrity over the Internet, cannot be guaranteed. Dividend yields change as stock prices change, and companies may change or cancel dividend payments in the future. All securities involve varying amounts of risk, and their values will fluctuate, and the fluctuation of foreign currency exchange rates will also impact your investment returns if measured in Canadian Dollars. Past performance does not guarantee future returns, investments may increase or decrease in value, and you may lose money. Leede employees may buy and sell shares of the companies that are recommended for their own accounts and for the accounts of other clients. Disclosure codes are used in accordance with Policy 3600 of CIRO.

Dissemination All final research reports are disseminated to existing and potential institutional clients of Leede Financial Inc. (Leede) in electronic form to intended recipients thorough e-mail and third-party aggregators. Research reports are posted to the Leede website and are accessible to customers who are entitled to the firm’s research. Reproduction of this report in whole or in part without permission is prohibited. Research Analyst Certification The Research Analyst(s) who prepare this report certify that their respective report accurately reflects his/her personal opinion and that no part of his/her compensation was, is, or will be directly or indirectly related to the specific recommendations or views as to the securities or companies. Leede Financial Inc. (Leede) compensates its research analysts from a variety of sources and research analysts may or may not receive compensation based upon Leede investment banking revenue. Canadian Disclosures This research has been approved by Leede Financial Inc. (Leede), which accepts sole responsibility for this research and its dissemination in Canada. Leede is registered and regulated by the Canadian Investment Regulatory Organization (CIRO) and is a member of the Canadian Investor Protection Fund (CIPF). Canadian clients wishing to effect transactions in any designated investment discussed should do so through a Leede Registered Representative.

U.S. Disclosures This research report was prepared by Leede Financial Inc. (Leede). Leede is registered and regulated by the Canadian Investment Regulatory Organization (CIRO) and is a member of the Canadian Investor Protection Fund (CIPF). This report does not constitute an offer to sell or the solicitation of an offer to buy any of the securities discussed herein. Leede is not registered as a broker-dealer in the United States and is not subject to U.S. rules regarding the preparation of research reports and the independence of research analysts. Any resulting transactions should be effected through a U.S. broker-dealer.

( Companies Mentioned: PROF:NASDAQ; PRN:TSX, )

Source: Dr. David Nierengarten 11/07/2024

TScan Therapeutics Inc. (TCRX:NASDAQ) Phase 1 ALLOHA study, evaluating its lead therapeutic candidates TSC-100 and TSC-101 in hematologic malignancies, showed patients continuing to have a positive response after one year, reported Wedbush analyst Dr. David Nierengarten in a Nov. 5 research note. TSC-100 and TSC-101 are T-cell receptor-engineered T-cell therapies (TCR-Ts).

"We see a catalyst-rich next few months ahead with data building in prominence on stock impact," Nierengarten wrote.

87% Return Potential

Wedbush has a US$10 per share target price on the Massachusetts-based biotech, trading at the time of the report at about US$5.36 per share, noted the analyst. The difference between these figures implies an 87% return potential for investors.

TScan Therapeutics remains rated Outperform.

Durability of Response Data

Nierengarten presented the clinical trial's latest results. As of the July 8, 2024 data cutoff date, in Phase 1 of ALLOHA, 16 patients with hematologic tumors had been administered TSC-100 or TSC-101, and 11 patients had been given a placebo. Median follow-ups had occurred at 5.8 months and 5.3 months, respectively.

At the time, none of the patients in the treatment arm had had a relapse. In the control arm, however, three, or 27% of, the 11 patients had, and the median time to relapse was 159 days. The analyst explained that this is typical for patients receiving a hematopoietic stem cell transplant after reduced-intensity conditioning.

One year out from treatment, five patients were evaluable, and all remained relapse free and minimal residual disease negative at the time. These data underscore the durability of response to this TCR-T treatment, Nierengarten commented. Its safety profile was shown to be favorable still, with no patients experiencing dose-limiting toxicities or adverse events associated with allogeneic hematopoietic cell transplantation.

"Enrollment continues in dose expansion cohorts, and results could support a registrational trial as early as 2025, pending regulatory feedback," Nierengarten wrote.

On the Horizon

TScan Therapeutics has several catalysts related to its clinical programs on the horizon, which Nierengarten listed.

On Nov. 8 and 9, the company will present preclinical data in the poster sessions at the annual Society for Immunotherapy of Cancer meeting. One poster will show in vitro combinatorial data for T-Plex, TScan's cellular therapy for treating solid tumors. It is comprised of two to three different TCR-Ts that target different tumor antigens on different human leukocyte antigen (HLA) types.

A second poster will detail the expansion of ImmunoBank, the biotech's diverse bank of therapeutic T-cell receptors (TCRs) that recognize diverse targets and are associated with multiple HLA types. The third will depict development of a target agnostic platform to evaluate how TCR-Ts affect primary human tissues.

On Dec. 9, TScan Therapeutics will present updated one-year data from ALLOHA, at the American Society for Hematology Annual Meeting in December.

By year-end, the biotech will announce initial data from administering singleplex therapy, cell therapy engineered using a single TCR, to patients with solid tumors. This treatment is being given to establish safety before administering multiplex therapy, cell therapy engineered from multiple TCRs.

In 2025, TScan Therapeutics will provide long-term duration of response data for multiplex therapy in solid tumors and will potentially commence a registrational trial for TSC-100 and TSC-101.

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Important Disclosures:

1. This article does not constitute investment advice and is not a solicitation for any 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. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
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, TScan Therapeutics Inc., November 5, 2024

Analyst Certification We, David Nierengarten, Martin Fan and Dennis Pak, 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 TScan Therapeutics, Inc.. 6. WS is acting as a financial advisor for TScan Therapeutics, Inc..

Wedbush disclosure price charts are updated within the first fifteen days of each new calendar quarter per FINRA regulations. Price charts for companies initiated upon in the current quarter, and rating and target price changes occurring in the current quarter, will not be displayed until the following quarter. Additional information on recommended securities is available on request. Disclosure information regarding historical ratings and price targets is available: Research Disclosures *WS changed its rating system from (Strong Buy/ Buy/ Hold/ Sell) to (Outperform/ Neutral/ Underperform) on July 14, 2009. Applicable disclosure information is also available upon request by contacting the Research Department at (212) 833-1375, by email to leslie.lippai@wedbush.com. You may also submit a written request to the following: Wedbush Securities, Attn: Research Department, 142 W 57th Street, New York, NY 10019.

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.

( Companies Mentioned: TCRX:NASDAQ, )

Source: Dr. Jonathan Aschoff 11/07/2024

BioRestorative Therapies Inc. (BRTX:OTCBB) received a provisional license from the New York State Department of Health (NYSDOH) to process allogeneic donor tissue for various cells, like stem, to be isolated, expanded, and cryopreserved for medical research, reported MKM analyst Dr. Jonathan Aschoff in a Nov. 5 research note.

The biotech develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells.

1,100% Upside Implied

Aschoff reiterated Roth's US$18 per share target price on the biotech, trading at the time of the report at about US$1.50 per share, the analyst noted. These figures reflect a potential return for investors of 1,100%.

BioRestorative Therapeutics remains a Buy.

Sources of Revenue

Aschoff discussed how BioRestorative can generate revenue. This new license is the second from NYSDOH that the biotech holds. The previous one allows it to process autologous mesenchymal stem cells, in other words, act as a tissue bank.

The U.S.-based biotech now may capitalize on its Current Good Manufacturing Practices capabilities and process, bank and distribute clinical-grade allogeneic biologics. This revenue generation would better position the biotech financially, "allowing it to reduce cash burn and dependence on equity markets," wrote Aschoff.

Another source of revenue for BioTherapeutics is from its supply agreement with Cartessa Aesthetics LLC signed earlier in 2024. Per the five-year agreement, BioTherapeutics will supply Cartessa with a preset minimum quantity of finished vials of the aesthetic company's initial cell-based biologic commercial product each year. This product, intended to reduce the appearance of fine lines and wrinkles, will be sold under the Chronos ExoCR mark. Cartessa, on the other hand, will give BioTherapeutics access to its marketing and distribution capabilities to get its technologies to aesthetic providers.

The biotech may expand the Cartessa agreement into a broader offering of biocosmeceuticals and therapeutics if future clinical trials support their approval by the U.S. Food and Drug Administration. This expansion would transform the partnership into "a vertically integrated biocosmeceutical platform," Aschoff wrote.

Clinical Trial Catalyst

Meanwhile, Aschoff reported, BioRestorative will continue its Phase 2 clinical evaluation of its novel back pain treatment, BRTX-100, in patients with chronic lumbar disc degeneration.

Preliminary results from this clinical trial are expected in late Q4/24 or early Q1/25.

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Important Disclosures:

1. Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor.
2. This article does not constitute investment advice and is not a solicitation for any 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. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
3. 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 Roth MKM, BioRestorative Therapies Inc., November 5, 2024

Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.

Disclosures: Within the last twelve months, ROTH Capital Partners, or an affiliate to ROTH Capital Partners, has received compensation for investment banking services from BioRestorative Therapies, Inc.. ROTH makes a market in shares of BioRestorative Therapies, Inc. and as such, buys and sells from customers on a principal basis. Shares of BioRestorative Therapies, Inc. may be subject to the Securities and Exchange Commission's Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities.

ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months. The material, information and facts discussed in this report other than the information regarding ROTH Capital Partners, LLC and its affiliates, are from sources believed to be reliable, but are in no way guaranteed to be complete or accurate. This report should not be used as a complete analysis of the company, industry or security discussed in the report. Additional information is available upon request. This is not, however, an offer or solicitation of the securities discussed. Any opinions or estimates in this report are subject to change without notice. An investment in the stock may involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Additionally, an investment in the stock may involve a high degree of risk and may not be suitable for all investors. No part of this report may be reproduced in any form without the express written permission of ROTH. Copyright 2024. Member: FINRA/SIPC.

( Companies Mentioned: BRTX:OTCBB, )

Source: Streetwise Reports 11/08/2024

Vertex Pharmaceuticals Inc. (VRTX:NASDAQ) has reported a robust financial performance for the third quarter of 2024. The report has demonstrated the company's continued revenue growth and the strengthening of its innovative pipeline. For Q3 2024, Vertex's product revenue reached US$2.77 billion, a 12% increase from the previous year. This was primarily driven by strong demand for its TRIKAFTA®/KAFTRIO® therapies. Based on this momentum, Vertex raised its full-year product revenue guidance to a range of US$10.8 billion to US$10.9 billion, citing a solid trajectory in its cystic fibrosis (CF) portfolio and expected future launches.

In Q3, the company made notable advancements in its pipeline. Three programs have begun moving into Phase 3 clinical development: suzetrigine in diabetic peripheral neuropathy (DPN), povetacicept in IgA nephropathy (IgAN), and VX-880 in type 1 diabetes (T1D). Vertex is also preparing for the launch of two potential treatments in early 2025, with PDUFA dates set for January 2 for the vanzacaftor triple therapy for CF and January 30 for suzetrigine, the latter being a pain medication in a new therapeutic class aimed at reducing reliance on opioids.

GAAP and Non-GAAP net income both reached US$1.0 billion, largely driven by increased product revenue, which offset rising R&D and SG&A expense. This was s due to investments in global commercialization and late-stage clinical development. For Q3, Vertex's combined R&D and SG&A expenses were US$1.2 billion and US$1.1 billion, respectively, an increase from last year attributed to new global program advancements and upcoming launch support.

Vertex's cash position remained strong, with US$11.2 billion in cash, cash equivalents, and marketable securities as of September 30. The decline from US$13.7 billion at the end of 2023 primarily reflects the acquisition of Alpine Immune Sciences and share repurchases under the company's buyback program.

A Look At Biotechnology and Pharma

The U.S. Pharmaceuticals Report for 2024 by Nova One Advisor detailed the size and growth trajectory of the U.S. pharmaceutical market. Valued at US$602.19 billion in 2023, the sector is projected to exceed US$1 trillion by 2033. The report pointed to a "high healthcare expenditure provided by government bodies" as a primary growth driver, further bolstered by the aging population's demand for advanced treatments.

In an October 24 article, The Investing News Network reported on a dynamic landscape within the biotechnology sector. The report highlighted advancements in AI-powered drug discovery. Despite a cautious investment climate, interest remained strong in AI's potential to reshape healthcare, with venture capital investment reaching US$6.59 billion. At the HealthTech Ignite conference, Susie Roberts from Relay Therapeutics expressed confidence, noting, "We will definitely see AI design drugs in the next 10 years."

On November 4, Yahoo! Finance shared insights from MIT professors Andrew Lo and Dennis Whyte. They emphasized that biotechnology's rapid advancement over the past five decades offers valuable lessons for future innovation. In their research paper, Lo and Whyte proposed initiatives to accelerate biotechnology's growth, underscoring the importance of "reducing risk and uncertainty" to foster a robust investment ecosystem that supports groundbreaking discoveries.

Catalysts Driving Vertex Pharma

According to Vertex's November 2024 investor presentation, the company sees multiple growth catalysts over the next few years. Vertex aims to meet its goal of achieving "five launches in five years," focusing on expanding the treatable patient base in CF with vanzacaftor triple, addressing critical needs in sickle cell disease (SCD) and beta thalassemia (TDT) with CASGEVY, and launching suzetrigine for acute pain management.

Additionally, Vertex expects its expansive R&D pipeline to support long-term growth. This includes pivotal clinical trials for VX-880 in T1D, povetacicept in IgAN, and NaV1.8 pain inhibitors like suzetrigine, indicating a commitment to treating a range of chronic and life-threatening conditions with limited therapeutic options.

By driving advancements in CF therapies, diversifying its portfolio with novel pain treatments, and pursuing accelerated approvals for renal and blood-related disorders, Vertex is strategically positioning itself to sustain growth and achieve several near-term milestones.

What Are Experts Saying About Vertex?

In a November 5, 2024, H.C. Wainwright & Co. update, the analysts highlighted promising data from Vertex's recent Phase 2 trial for suzetrigine, which showed encouraging reductions in pain intensity. [OWNERSHIP_CHART-4085]

The analysts noted that suzetrigine's peripheral nervous system-specific mechanism could potentially address "a significant, unmet medical need worldwide" in non-opioid pain management. They set a price target of US$600.00, projecting Vertex's continued growth from its strong cystic fibrosis franchise and pipeline expansion.

From the November 7 Kingswood Capital Partners report, analysts noted Vertex Pharmaceuticals' "sustained execution" in advancing product development programs and achieving robust operating margins, enabling "continued, significant investments" in both its pipeline and commercial capabilities. The firm maintained a "Buy" rating with a 12-month target price of US$550.00, attributing this outlook to Vertex's deep cash resources and historical successes in clinical trials.

Ownership and Share Structure

According to Refinitiv, 95.44% of Vertex Pharmaceuticals is held by Institutions. The top among them are Capital World Investors at 10.37%, The Vanguard Group at 8.88%, BlackRock Institutional Trust with 5.49%, State Street Global Advisors (US) with 4.55%, and Fidelity Management and Research with 4.11%. Strategic Investors hold .12%. The rest is retail.

The company's market cap is US$129,395.59 million with 257.07 million free float shares. The 52 week range is US$341.90–$510.64.

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Important Disclosures:

1) James Guttman wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee.

2) This article does not constitute investment advice and is not a solicitation for any 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. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.

For additional disclosures, please click here.

( Companies Mentioned: VRTX:NASDAQ, )

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