Source: Dr. Ram Selvaraju 10/18/2024

Anavex Life Sciences Corp. (AVXL:NASDAQ) recently released encouraging preliminary electroencephalography (EEG) biomarker results from Part A of the ongoing Phase 2 clinical study of ANAVEX3-71 for schizophrenia treatment, according to an H.C. Wainright & Co. research note.

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.

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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, )

Mamadou Tahirou Diallo, PharmD lends years of expertise to his work with Cardinal Health

Heather D. Embree, MS, honored for her leadership and expertise in program management and drug development

Visible particle is an important issue in the biopharmaceutical industry, and it may occur across all the stages in the life cycle of biologics. Upon the occurrence of visible particles, it is often necessary to conduct chemical identification and root cause analysis to safeguard the safety and efficacy of the biotherapeutic products. In this article, we present a number of typical particles and relevant root cause analysis in the categories of extrinsic, intrinsic, and inherent particles that are commonly encountered in the biopharma industry. In particular, the optical images of particles obtained both in situ and after isolation are provided, along with spectral and elemental information. The particle identification was carried out with multiple microscopic and microspectroscopic techniques, including stereo optical microscopy, Fourier-transform infrared microscopy, confocal Raman microscopy, scanning electron microscopy, and energy dispersive X-ray spectroscopy. Both commercial and in-house spectral databases were used for comparison and identification. In addition to particle identification, we placed significant efforts on the root cause analysis of the addressed particles with the intention to provide a relatively whole picture of the particle-related issues and practical references to particle mitigation for our peers in the biopharmaceutical industry.

Waters Corporation and NIBRT Partner to Bring Greater Control and Predictability to Biopharmaceutical Processing

Keryx Biopharmaceuticals Initiates Phase 3 Registration Program of Zerenex (ferric citrate) for the Treatment of Patient

The drug, marketed as Hamsyl – Junior will now be available in a 1500 IU pack, and is priced at ₹Rs 20,970, a company official told businessline

Source: Streetwise Reports   04/22/2020

The new data are reviewed and updates are provided on Can-Fite BioPharma's other clinical studies, including one for COVID-19, in this Dawson James research report.

In an April 20 research note, Dawson James analyst Jason Kolbert wrote that results from Can-Fite BioPharma Ltd.'s (CANF:NYSE.MKT) Phase 2 trial of Namodenoson for nonalcoholic fatty liver disease with or without nonalcoholic steatohepatitis "look pretty good."

He added that "the consistency of the data from the studies (preclinical and clinical), should support business development interest."

Dawson James has a $9 per share target price on Can-Fite; the stock is currently trading at around $1.75 per share.

Kolbert recapped the study design and provided the results.

This purpose of this multicenter, randomized, double-blinded, placebo-controlled trial involving 60 patients was to determine dose efficacy and safety. Patients were treated twice a day with either 12.5 milligrams or 25 milligrams of oral Namodenoson or a placebo for 12 weeks.

The primary endpoint was effect on inflammation, measured by mean percent change from baseline in alanine transaminase blood levels and safety. The second endpoints included the percent change from baseline in liver fat, as determined by MRI proton density fat fraction.

In terms of safety, study participants tolerated Namodenoson at both doses, and no adverse events were reported. Otitis media occurred in two patients but was deemed to be unrelated to the drug. The four other events that occurred that were drug related were mild and self-limited.

Regarding efficacy of Namodenoson, Kolbert noted that "for a small Phase 2 exploratory study, there appears to be a significant efficacy signal."

Kolbert provided updates on other Can-Fite clinical trials.

The company's COVID-19 trial is now designed. Plans call for it to be randomized, open label, and double armed with Piclidenoson administered plus standard supportive care, compared to standard supportive care alone, in 40 hospitalized COVID-19-infected patients with moderate to severe symptomatic disease.

Patients are to be randomized at a 1:1 ratio to one of the trial arms and treated for up to four weeks. The primary efficacy measures will be time to resolution of viral shedding, time to resolution of clinical symptoms, respiratory function, need for ventilatory support and overall mortality.

Piclidenoson, Can-Fite's lead drug candidate, also is in Phase 3 in two indications: moderate to severe rheumatoid arthritis (the ACROBAT study) and moderate to severe plaque psoriasis (the COMFORT study). Enrollment for both trials is more halfway complete. In both, Piclidenoson "hold great promise as alternative therapies with what appears to be a more favorable side effects profile," Kolbert commented.

Dawson James has a Buy rating on Can-Fite BioPharma.

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Analyst Certification: The analyst(s) whose name appears on this research report certifies that 1) all of the views expressed in this report accurately reflect his (their) personal views about any and all of the subject securities or issuers discussed; and 2) no part of the research analyst’s compensation was, is, or will be directly or indirectly related to the specific recommendations or views expressed by the research analyst in this research report; and 3) all Dawson James employees, including the analyst(s) responsible for preparing this research report, may be eligible to receive non-product or service specific monetary bonus compensation that is based upon various factors, including total revenues of Dawson James and its affiliates as well as a portion of the proceeds from a broad pool of investment vehicles consisting of components of the compensation generated by investment banking activities, including but not limited to shares of stock and/or warrants, which may or may not include the securities referenced in this report.

( Companies Mentioned: CANF:NYSE.MKT, )

Biopharma shares have outperformed the broader market year-to-date, giving rise to apprehension over whether a pullback is in the offing. An analyst at BofA Securities said Friday that now is the time to go from defensive to offensive in the sector, as quarantines are winding down in several parts of the globe.The Biopharma Analyst Analyst Geoff Meacham shortlisted Eli Lilly And Co (NYSE: LLY), Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX), Bristol-Myers Squibb Co (NYSE: BMY), BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) and Amgen, Inc. (NASDAQ: AMGN) as biopharma stocks where he would put his money to work.The analyst has the following ratings and price targets for the shares: * Lilly: Buy/$165 * Vertex: Buy/$300 * Bristol-Myers Squibb: Buy/raised the price target from $75 to $80 * BioMarin: Buy/lifted price target from $110 to $120 * Amgen: Buy/price target increased from $265 to $2755 Reasons For BofA's Bullish Disposition BofA is increasingly bullish on the biopharma group due to the following factors, Meacham said: * Expectations for robust revenue growth of 6% in the second half of 2020 compared to the first-half, which is double that of the S&P 500's revenue growth. * Reasonable price-earnings for the stocks in the sector. * Many value-creating events lined up for the second half. * Lower policy risk stemming from goodwill earned from the COVID-19 pipeline. * A consistently positive FDA backdrop.Q1 Earnings Get 'A' Grade All of the big biotechs and major pharma companies reported both revenue and adjusted EPS beats in the first quarter, with Lilly and Vertex even raising some parts of their 2020 guidance, Meacham said.Citing slower new starts and forex headwinds, Bristol-Myers Squibb and BioMarin lowered their 2020 revenue guidance, but maintained their EPS guidance, the analyst said. Meacham expressed surprise at Merck & Co., Inc. (NYSE: MRK) and Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) lowering their 2020 revenue and adjusted EPS guidance, given his belief that oncology or orphan diseases wouldn't be as sensitive to COVID-19 disruption.See also: Attention Biotech Investors: Mark Your Calendar For These May PDUFA Dates Lilly One of The Higher Quality Stocks In BofA's Coverage Lilly is a source of differentiated growth given its early product cycle and diversified base business, including diabetes, immunology and immunotoxicology and migraine, and an advancing late-stage pipeline of potentially best-in-class or first-in-class therapies, Meacham said.The analyst said he likes Lily's potential for additional earnings growth in 2020-2021 and views Lilly as one of the higher quality stocks in his coverage despite its higher valuation. The prospects for 2021 look attractive, with selpercatinib potentially launching in non-small cell lung cancer and thyroid cancer by year's end, and tirzepatide approval in 2021 representing a "step change" for the diabetes franchise, he said. Consensus For Vertex To Move Higher? Vertex has a richer -- though well-deserved -- valuation, due to its differentiated growth profile, Meacham said.Given that Vertex's commercial execution is largely unaffected by the COVID-19 pandemic, the analyst said investors will begin to look forward to 2021 sooner than for other companies with more commercial risk.BofA expects consensus estimates to continue to move higher, making Vertex's valuation even more attractive.Bristol-Myers Has Highly Differentiated Growth With an estimated 8% revenue growth and 19% EPS growth in 2021 compared to 5-6% and 12%, respectively, for peers, and with six new launches expected this year, 2020 is shaping up to be a very robust period for Bristol-Myers despite the ongoing COVID-19 headwinds, Meacham said. The analyst said the company's growth looks highly differentiated.An increasingly diversified product mix and beatable launch expectations position the company for meaningful upside to consolidated P&L, with improving synergies, he said. BioMarin's 'Game-Changing' Late-Stage Pipeline BioMarin's late-stage pipeline in valrox and vosoritide have improved its growth outlook, Meacham said.The analyst termed the company's late-stage pipeline as "game-changing." The second-half launch of Roctavian is the most important catalyst for the company this year, with the product likely to accelerate the company's already above-average growth profile, he said. "We see BioMarin as one of the higher quality names in our coverage universe given its clean growth story and it remains our SMid cap top pick." Amgen Looks To New Product Growth To Compensate For Legacy Product Erosion The long-term outlook for Amgen's Otezla is improving given the recently announced Phase 3 data for mild-to-moderate psoriasis, Meacham said.The company rapidly refocused its story from legacy product erosion to new product growth with the acquisition of Otezla from the Bristol/Celgene deal, the analyst said. "Since then Amgen's growth profile has only improved, led by an expanded addressable market for Otezla, outperforming Amgen Biosimilars and Evenity franchises, aggressive formulary negotiation for Aimovig, and an exciting pipeline in AMG 510 and tezepelumab looking to contribute as soon as 2021." The Price Action The iShares NASDAQ Biotechnology Index (NASDAQ: IBB) was last seen trading up 1.25% to 128.76, adding to its 5.6% year-to-date gain. Related Link: The Week Ahead In Biotech: Smid-Cap Earnings News Flow Picks Up Pace See more from Benzinga * The Daily Biotech Pulse: Ayala IPO, Pluristem Starts Phase 2 Trial Of COVID Treatment, European Nod For Takeda * The Daily Biotech Pulse: FDA Approves Novartis Lung Cancer Drug, 2-Way Contest Emerging For Tetraphase Pharma, Dexcom To Join S&P 500 * The Daily Biotech Pulse: FDA Nod For AstraZeneca, AbbVie-Allergan Deal Clears Antitrust Hurdle(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

(United States Federal Circuit) - Vacating the Patent Trial and Appeal Board's dismissal of an interference claim for lack of standing and remanding for further proceedings because the description of a method for removing hair using nanoparticles to damage hair follicles was a sufficient written description under the Patent Act because although the description only gave optical density rather than particles per ml, this was enough of a disclosure to convey to those skilled in the art that the inventor had possession of the claimed subject matter.

Learn how digital tech is accelerating medical breakthroughs by registering your team to attend Xcelerating Life Sciences Boston: Biopharma’s Future in Digital Health. While some content focuses on the Boston ecosystem, we’re confident the forum – and virtual networking – will be valuable to a national audience. The May 13, 2020 event will explore the […]

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M&A is an omnipresent reality in the biopharma industry, from Big Pharma mega-mergers to smaller acquisitions of emerging startups. We’ve recently witnessed several large M&A transactions get closed or announced, including BMS-Celgene, Takeda-Shire, and AbbVie-Allergan; according to BMO Capital Markets

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Venture capital firm Frazier Healthcare has grabbed Scott Byrd, Ian Mills, and Gordon McMurray as its new Entrepreneur-in-Residence consultants.

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Biocon Executive Chairperson Kiran Mazumdar-Shaw has been recognised for her contribution to the world of medicine as an entrepreneur and innovative business leader, the Bengaluru-headquartered biopharmaceuticals company said in a statement.