“Beware of missing chances; otherwise it may be altogether too late some day.” – Franz Liszt, Hungarian Composer October 22, 1811 – July 31, 1886
Hump Day’s markets were met with a number of macroeconomic reports. The Total CPI report confirmed a rise by .5% M/M in December & Y/Y it is now up 7%, the highest increase in 40 years. CPI measures how much we all pay in America for our goods and services and the current increase is most like attributed to labor and supply shortages. Let’s hope these pressures are resolved in 2022. The Treasury Budget report also confirmed a $21.3B deficit in December, while over the last 12-months it is $2.58T. The weekly MBA Mortgage Applications Index report confirmed a 1.4% rise. The Weekly EIA crude oil inventories report confirmed another drop by 4.55M barrels & oil prices jumped another 31.7% to close at $82.52/bbl.
The yield curve backed off again today as the 2-yr yield closed down 1 basis point at .89% & the 10-yr yield moved lower by 2 basis points to end at 1.73%.
10 of the 11 sectors rose today with the materials sector moving up 1% to lead a slightly positive overall move in the markets, while the health care sector fell .3%. The large cap indices managed to end on the green as S&P 500 closed at 4,726.35 (+.28%), the Dow 30 closed at 36,290.32 (+.11%), & the Nasdaq closed at 15,188.39 (+.23%). However, the small caps on the Russell 2000 dropped to close at 2,176.06 (-.82%) and curiously the MicroCaps closed down equally with the iShares Micro-Cap ETF (IWC) closing at $135.53, -.82%.
The biotech sector closed lower again as the SPDR S&P Biotech ETF (XBI), a barometer of the smaller biotech stocks, closed at $100.60, -3.17% and near its recently established 52-wk low. The 52-wk range is $100.05 – $174.79. Can we find a bottom in this sector soon?
The U.S. Dollar Index fell .7% to 94.95, gold prices closed at $1,827/oz., +$6/oz., silver closed at $23.18, +$.40, Bitcoin (BTC) closed at $43,969.18, +2.77% over the past 24-hours & oil prices jumped another 3.9% to close at $81.14/bbl.
Today, Medicare significantly restricted the coverage of Biogen’s (BIIB, $225.34, -6.7%) Alzheimer’s drug, Aduhelm, for only those patients enrolled in clinical studies that have mild symptoms of the disease. The search for a reasonable treatment continues on for this terrible disease that, as of 2020, has grabbed hold ~50 million people worldwide. INmune Bio’s (NASDAQ: INMB) XPro1595 is a protein biologic that targets soluble TNF (sTNF) and may have many beneficial effects in patients with Alzheimer’s disease by decreasing neuroinflammation. INmune Bio believes that decreasing neuroinflammation may slow or stop the progression of the cognitive and psychiatric symptoms of Alzheimer’s patients and improve in the overall quality of life of the patient and their care-givers. At INmune Bio, they view Alzheimer’s as an immunologic disease with the neurological symptoms of dementia and psychiatric dysfunction. Approaching Alzheimer’s disease as an immunologic disease changes the drug discovery process, changes the way clinical trials are designed, and may provide hope for patients and their care-givers. Learn more by clicking here.
Shares of Vir Biotechnology (VIR) rose to close at $40.01, +15.07%. The move came after GlaxoSmithKline plc (LSE/NYSE: GSK. $42.24, +.44%) and Vir Biotechnology, Inc. (Nasdaq: VIR) announced that the US government will purchase an additional 600,000 doses of sotrovimab, an investigational monoclonal antibody for the early treatment of COVID-19, enabling further nationwide access to sotrovimab for patients. The additional 600,000 doses will be delivered throughout the first quarter of 2022. This agreement is an amendment to earlier commitments announced with the US government in November 2021
On Tuesday, I hosted a Tribe Public Webinar Presentation and Q&A Event with Nauticus Robotics (NASDAQ: CLAQ, $10.08, +1.61%) Founder, Chairman & Chief Executive Officer, Nicolaus Radford & Eli Spiro, CEO of CleanTech Acquisition Corp for their presentation titled “From Space to sea – Tesla of the Subsurface”
. They were also available for a 5-10 minute Q&A session at the end of the presentation. You may view the event video at the Tribe Public YouTube Channel by clicking here.
The event speaks, in part, to the overall oceanic economy, which counting both the seas and the shores, amounts to $2.5 trillion per year. Did you know that if the ocean were a country, it would have the seventh-largest GDP on Earth? That number could continue to grow — but only if our planet’s many seas remain in good health. We also learned about Nauticus Robotics and how they have developed revolutionary cloud-based autonomy software to enable a smarter and more sustainable ocean industry using its fleet of autonomous robots from the surface to the seabed. These robots are enabled by the Nauticus Software Suite, a platform of AI/ML technologies designed to disrupt the legacy methods in the marine industry. Its first product offering, Aquanaut, is the world’s first tetherless underwater robot capable of robust decision making for both long distance ocean data collection and close-in dexterous manipulation of the subsea environment, supporting government & defense and other commercial industry sectors. Nauticus’ software, robots, and services provide customers the necessary data collection, analytics, and subsea manipulation capabilities to support and maintain assets, while significantly reducing their operational and carbon footprints to improve offshore health, safety, and environmental exposure.
VP WATCHLIST UPDATES
Apple (AAPL) closed at $175.08, +1.68%. According to Reuters
, “South Korea’s telecommunications regulator said on Tuesday Apple had submitted plans to allow third-party payment systems on its App Store to comply with a law banning major app store operators from forcing software developers to use their payments systems.”
Tesla (TSLA) closed at $1,106.22, +3.93%. Today, Tesla announced that will post its financial results for the fourth quarter and full year ended December 31, 2021 after market close on Wednesday, January 26, 2022. At that time, Tesla will issue a brief advisory containing a link to the Q4 and full year 2021 update, which will be available on Tesla’s Investor Relations website
. Tesla management will hold a live question and answer webcast that day at 4:30 p.m. Central Time (5:30 p.m. Eastern Time) to discuss the Company’s financial and business results and outlook. Yestersday, Barrons reported
that “Tesla delivered almost 71,000 vehicles from its Shanghai plant in December, according to Citigroup analyst Jeff Chung.”
The Walt Disney Company (DIS) closed at $157.80 +.06%. CEO Bob Chapek recently outlined that Disney’s “3 pillars” are storytelling, innovation & a “relentless focus on our audience.”
He added,“Over the last two years, we continued to tell the world’s best stories, reorganized, and accelerated our transformation to better serve audiences and guests. We looked inward during a time of social disruption, saw how much was left to do, and made significant change. And of course, we underwent a leadership change — and I am enormously grateful for the tremendous foundation Bob Iger left us.”
Disney will hold its annual meeting of shareholders on Wednesday, March 9, 2022 at 1:00 p.m. ET / 10:00 a.m. PT by virtual meeting and will be made available via webcast at www.disney.com/investors
On the small side, Atossa Therapeutics (NASDAQ: ATOS), a clinical-stage biopharmaceutical company seeking to develop innovative proprietary medicines in oncology and infectious disease with a current focus on breast cancer and COVID-19, rose to an intraday high of $1.5674 prior to closing at $1.49, -3.25% on 1.866M shares of trading volume. On Dec. 22, Atossa announced that it has initiated enrollment of its Phase 2 clinical study of oral Z-Endoxifen in Sweden
. Participants in the study will be premenopausal women with elevated mammographic breast density, which is an emerging public health issue affecting more than 10 million women in the United States and many more worldwide. “This is an extremely important milestone as it marks the next phase of developing our proprietary Z-Endoxifen,”
said Steven Quay, M.D., Ph.D., Atossa’s Chairman and CEO. “This study will help determine the relationship between daily doses of Endoxifen and reduction in breast density and will help us further assess safety and tolerability. We look forward to providing progress updates as they become available.”
Physician-Scientist and CEO of Atossa, Steven Quay, MD, PhD, recently published an e-print on his research into a new coronavirus, named BANAL-236, reported by the Institut Pasteur in September 2021. At the time, BANAL-236 was the first bat coronavirus with high homology to SARS-CoV-2 that could directly infect human cells using the same receptor that SARS-CoV-2 uses. The new research reports that BANAL-236 has evolved the ability to infect human cells by an unknown mechanism that violates over 40 years of coronavirus research. The COVID-19 e-print is available here
and has also been submitted to Nature. “When I read the paper from the Institut Pasteur and looked at the virus, I immediately assumed there was an error in either the way the sequence was assembled or a mix up in the lab with another virus to explain the infectivity,”
Quay said. “I contacted the Institut Pasteur with my findings and was deeply disturbed to learn that there was not, in fact, some simple mistake had occurred to explain things. I now knew we were in uncharted waters with a virus that is missing eight key elements that have been shown, over 40 years of research, to be required for growth.”
Atossa management also recently presented at “A Town Hall Q&A Event With Atossa Therapeutics Management Team”
with Tribe Public. You can view it clicking here
. Atossa also announced recently that it had completed a pre-investigational new drug (PIND) meeting with the FDA to obtain input from the FDA on pre-clinical, clinical, manufacturing and regulatory matters in the U.S. for Atossa’s proprietary Z-endoxifen to treat breast cancer in the neoadjuvant (prior to surgery) setting.
On Jan. 10, Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for FT536, an off-the-shelf, multiplexed-engineered, iPSC-derived, chimeric antigen receptor (CAR) NK cell product candidate. FT536 is derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with four functional elements, including a novel CAR that uniquely targets the α3 domain of the major histocompatibility complex (MHC) class I related proteins A (MICA) and B (MICB). MICA and MICB are stress proteins that are expressed at high levels on many solid tumors. The Company plans to initiate clinical investigation of FT536 as a monotherapy and in combination with tumor-targeting monoclonal antibody therapy for the treatment of multiple solid tumor indications. Shares of FATE closed at $45.05, -5.24%.
InMed Pharmaceuticals Inc. (NASDAQ: INM), a leader in the development, manufacturing and commercialization of rare cannabinoids, closed at $1.26, -3.08% after hitting an intraday high of $1.31. On Jan. 6, InMed’s CEO Eric A. Adams, Shane Johnson, SVP and General Manager of BayMedica and Chris Meiering, VP of Commercial Operations, presented at Tribe Public’s Webinar Presentation and Q&A Event titled “Addressing The Increasing Demand For Rare Cannabinoids.”
On Jan. 5th, InMed issued its Annual Letter to Shareholders
from President and CEO Eric A. Adams which stated, “Building on a very strong 2021, we are looking forward to 2022 with the continued advancement of our pharmaceutical drug development programs and, with our acquisition of BayMedica, transitioning to becoming a leading B2B supplier of rare cannabinoids to the consumer health and wellness sector. I’m very excited to provide updates on our progress as we begin to commercialize new products and explore an array of rare cannabinoids for their potential therapeutic applications.” Click here to read the letter
INmune Bio, Inc. (NASDAQ: INMB), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, recently presented data at the San Antonio Breast Cancer Symposium showing mucin 4 (MUC4) expression predicts worse survival and is a treatment resistance factor in women with triple negative breast cancer (TNBC).
INB03, a DN-TNF therapy, can reverse TNBC treatment resistance by decreasing expression of MUC4 and reducing immunosuppression in the tumor microenvironment (TME) by increasing anti-tumor macrophage phagocytosis and increasing lymphocyte function in the TME. The poster will be presented by Dr. Roxana Schillaci, Instituto de Biología y Medicina Experimental, Buenos Aires, on December 10th. RJ. Tesi, M.D, Chief Executive Officer of INmune Bio, commented, “We are excited to have Dr. Schillaci present these data that expand on her previous findings on the role of MUC4 expression which predicts worse survival and resistance to therapy in HER2+ breast cancer therapy. Now, in both TNBC and HER2+ breast cancer, MUC4 predicts resistance to immunotherapy and an immunosuppressive TME that can be overcome with INB03.” Treatment with INB03 in murine models of breast cancer improves macrophage anti-tumor phagocytic activity, lymphocyte infiltration and function suggesting improved response to combination therapies of INB03 with inmunotherapy. Shares of INMB closed trading today at $8.92, -3.04% after hitting an intraday high of $9.36.
Shares of INVO Bioscience, Inc. (NASDAQ: INVO), a medical device company focused on commercializing the world’s only in vivo culture system (IVC), INVOcell®, climbed again today and closed at $3.82,+4.37% the high for the day, but still well off of its 52-wk high of $12.30. A sell side analyst named Kyle Bauser, Ph.D. at Colliers Securities recently published his Buy Rating Report with a $6 Price Target. On Dec. 16, INVO Bioscience, Inc. announced
that it has entered into an expanded agreement with Ovoclinic, a group of clinics specialized in assisted reproductive treatments with four locations across Spain (Madrid, Marbella, Málaga, Ceuta) and collaborating centers around Europe, to accelerate adoption of INVOcell within their markets. The agreement includes the expanded adoption of INVOcell within Ovoclinic locations as well as establishing an INVO Center of Excellence for future training for the European Market. Cristina Gonzalez, embryologist and Quality Manager of Ovoclinic laboratories stated, “After several successful trials implementing the exciting INVOcell fertility treatment, Ovoclinic aims to provide its patients with this effective alternative to the processes used so far in Spain in the field of reproductive medicine. We consider INVOcell to be an effective method of natural reproduction that involves the future mother at the very first moment of the process. We are confident that this innovative treatment will help many patients to choose this new alternative solution to achieve their dream of forming a family by actively participating in the reproductive process.”
According to the World Bank, Spain, with total population of approximately 47 million people, has one of the lowest fertility rates in Europe, affecting approximately 15% of the population, or one in seven couples of reproductive ages. According to reports, in 2010, there were approximately one million couples requesting assisted reproductive treatment, however only 22% received one or more assisted reproductive treatment cycles. The average waiting time for an IUI or IVF cycle in a public health facility was 339 days. Ovoclinic reports that they maintain the best technical and human resources to deal with all kinds of infertility problems along with the simplest and most natural treatments to the most complex and advanced techniques pioneered in Spain. Ovoclinic also works in partnership with Ovobank, the first European Donor Egg Bank in Europe.
Shares of Hecla Mining Company (NYSE: HL), the largest silver producer in the United States closed at $5.21, +1.96%.
Shares of NeuBase Therapeutics (NASDAQ: NBSE), a biotechnology platform company Drugging the Genome™ to address disease at the base level using a new class of precision genetic medicines, closed at $2.29, -4.58% after hitting an intraday high of $2.48. The 52-wk range is $2.29-$12.89. On Jan. 10, NeuBase announced the appointment of Todd P. Branning as Chief Financial Officer (CFO). Mr. Branning has more than 25 years of experience leading corporate finance and accounting, tax, financial planning and analysis, and investor relations for several publicly traded pharmaceutical companies. Prior to joining NeuBase, Mr. Branning was CFO of Phathom Pharmaceuticals, Inc., a publicly traded late clinical-stage biopharmaceutical company. Before that, he was Senior Vice President, CFO of Amneal Pharmaceuticals, Inc., a publicly traded pharmaceutical company, where he helped to build, leverage, and optimize infrastructure following the completion of a transformational merger. Prior to joining Amneal, he was Senior Vice President, CFO of the global generic medicines division at Teva Pharmaceutical Industries Ltd., a multinational generic pharmaceuticals company, where he led the finance function and served on the leadership team responsible for managing the day-to-day operations of Teva’s largest multi-billion-dollar commercial unit. Mr. Branning has also held financial leadership roles at Allergan plc, PricewaterhouseCoopers LLP, PPG Industries, Inc., and Merck & Co., Inc. Mr. Branning received his BBA from the University of Miami and MBA from Carnegie Mellon University. Mr. Branning is also a Certified Public Accountant and has completed a CFO certification program at The Wharton School at the University of Pennsylvania.
On Jan. 5, Neubase announced the appointment of Eric J. Ende, M.D., to the Company’s Board of Directors. Dr. Ende has nearly 25 years of experience in advising biotechnology and life sciences companies to optimize corporate strategy and structure and maximize shareholder value. “Dr. Ende has the experience and perspective to recognize the opportunity ahead for NeuBase as it plans for the clinical development of its potentially transformational new class of precision genetic medicines,” said Dietrich A. Stephan, Ph.D., Founder, CEO and Chairman of NeuBase. “We welcome Dr. Ende’s strategic insight as we begin to scale our therapeutic candidate pipeline from our new precision genetic medicines platform technology. In addition to his broad experience, he also shares in our Company’s goal of helping millions of patients with both common and rare conditions that currently have limited or no treatment options.” “I believe NeuBase has a game-changing technology that overcomes the limitations of early precision genetic medicines by delivering mutation selectivity, repeat dosing, and systemic administration in a modular precision medicine platform with the potential to efficiently scale to treat a wide variety of diseases that are currently undruggable,” said Dr. Ende. “I look forward to working closely with NeuBase’s leadership team and Board of Directors to elevate strategy and operations in order to create exceptional value for patients and shareholders.” Dr. Ende currently is the President of Ende BioMedical Consulting Group. He also is a member of the Board of Directors of Matinas BioPharma, where he is the Chairman of the Compensation Committee and serves on the Audit and the Nomination & Governance Committees, and of Avadel plc, where he is the Chairman of the Nomination & Corporate Governance Committee and serves on the Audit and Compensation Committees. Dr. Ende previously served on the Board of Directors of Progenics (acquired by Lantheus Holdings) and Genzyme (acquired by Sanofi-Aventis for $20 billion). During his time on Genzyme’s Board of Directors, Dr. Ende was a member of the Audit and Risk Management Committees. Prior to Genzyme, Dr. Ende was a biotechnology analyst, previously serving at Merrill Lynch, BofA Securities, and Lehman Brothers. Dr. Ende received an M.B.A. from NYU Stern School of Business, an M.D. from the Icahn School of Medicine at Mount Sinai, and a B.S. in biology and psychology from Emory University.