Markets ‘Stair Step’ Down Again On Hump Day – $AG $HL $PG $UNH $VALN Rise!

By John F. Heerdink, Jr.

Quote of The Day – “Infrastructure investment in science is an investment in jobs, in health, in economic growth and environmental solutions.” – Oren Etzioni, American Businessman, Born: 1964

The markets teased us a bit today as it climbed out of the gate then proceeded to stair step its way down again throughout the day. 9 of the 11 sectors finished solidly in the red with only the consumer staples sector rising .7% & the utilities sector rising .5%. Popular growth issuers essentially got pounded again today as the consumer discretionary sector fell 1.8% & the information technology sector 1.4%. Interestingly, the financials sector also dropped 1.7% as the yield curve pulled back as the 2-yr yield dropping 2 basis points to 1.01% & the 10-yr yield falling 4 basis points to 1.83%. The biotech sector also continued to crash as valuations dropped precipitously as the SPDR S&P Biotech ETF (XBI), a barometer of the smaller biotech stocks, closed at $93.50, -1.08% near its newly established 52-wk low. The 52-wk range is $93.37 – $174.79. Again, can we please find a bottom in this sector soon!?

The U.S. Dollar Index ticked down .2% to close at 95.56, Bitcoin (BTC) closed at $41,869.04, -1.26% over the last 24-hours, & oil prices surged again to close at $86.86., +1.38%. Precious metals rose as gold prices closed at $1,840/oz., +$25/oz. & silver closed at $24.13, +$.64. Two producers Hecla Mining Company (HL) rose to $5.78, +11.80% and First Majestic Silver Corp. (AG) rose to $11.88, +12.71%.

The macroeconomic schedule also delivered the Housing starts report, which confirmed a rise by 1.4% M/M in December to a seasonally adjusted annual rate of 1.702M. Housing permits also rose 9.1%M/M to 1.873M. The weekly MBA Mortgage Applications Index report confirmed a rise by 2.3%.

In turn, the large cap indices dropped as follows: the S&P 500 closed at 4,532.76 (-.97%), the Dow 30 closed at 35,028.65 (-.96%), & the Nasdaq, packed full of growth stocks from the information tech sector and beyond, got hit very significantly again and closed at 14,340.25 (-1.15%). However the small caps on the Russell 2000 got hit even worse today and dropped to close at 2,062.78 (-1.60%) and the MicroCaps closed down with the iShares Micro-Cap ETF (IWC) closing at $128.53, -1.72% establishing a new 52-wk low.

FURTHER AFIELD

Shares of two Dow 30 components, Procter & Gamble (PG, $162, +3.4%) & UnitedHealth (UNH, $462.52, +.3%), rose as they reported earnings beats today.

Shares of Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, rose to close at $47.52, +45.01% today after they announced results from an initial laboratory study demonstrating that serum antibodies induced by three doses of Valneva’s inactivated COVID-19 vaccine candidate, VLA2001, neutralize the Omicron variant. Sera from 30 participants in the Phase 1/2 trial VLA2001-201 were used in a pseudovirus assay to analyze neutralization of the ancestral SARS-CoV-2 virus as well as the Delta and Omicron variants. All 30 samples (100%) presented neutralizing antibodies against the ancestral virus and Delta variant, and 26 samples (87%) presented neutralizing antibodies against the Omicron variant. The mean fold reduction of neutralization relative to the ancestral virus was 2.7-fold for Delta and 16.7-fold for Omicron. Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “We are extremely pleased with these results, which confirm the potential for broad-spectrum protection of our inactivated, adjuvanted whole virus vaccine and its ability to address currently circulating variants of concern. These results add to earlier findings from our Cov-Compare Phase 3 trial, in which two doses of VLA2001 given as a primary vaccination were shown to induce superior neutralizing antibody levels and a broad T-cell response. We continue to believe that VLA2001 could be an important component of the fight against COVID-19, and Valneva remains fully committed to bringing VLA2001 to people who need it as soon as we can.”

On Jan. 11, I hosted a Tribe Public Webinar Presentation and Q&A Event with Nauticus Robotics (NASDAQ: CLAQ) 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 $166.23, -2.10%. According Bloomberg, Apple Inc. and Google warned U.S. lawmakers on Tuesday that bipartisan antitrust legislation aimed at curbing the power of big technology companies would harm the privacy and security of users if it becomes law.

Tesla (TSLA) closed at $995.65, -3.38%. Tesla 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 .Recently, 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 $150.11, -1.42%. 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. Disney’s CEO Bob Chapek’s comp for the company’s fiscal 2021 grew to ~$32.5. easily doubling his take home last year.

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 $1.415 prior to closing at $1.35, -2.88% on 2.374M shares of trading volume. On Jan. 18, Atossa announced it is advancing to enroll participants in Part B of its Phase 1/2a clinical study of AT-H201 in Australia, consisting of multiple ascending dose cohorts in healthy participants. The nebulized formulation, AT-H201, is being developed as an inhalation therapy for moderately to severely-ill hospitalized COVID-19 patients and for “long-haul” patients with post-infection pulmonary disease.
Part A of the study, which consisted of a single ascending dose group of 4 cohorts of healthy participants, has now been completed. The Australian Human Research Ethics Committee has reviewed the safety data from Part A and has approved the study to proceed to Part B. “The results of the first part of the study were extremely encouraging and the ethics committee concluded we may now proceed to enroll the next group of participants,” said Steven Quay, M.D., Ph.D., Atossa’s CEO and President. “A record number of hospitalizations driven by the Omicron variant is producing a crisis at many healthcare facilities. Additional therapies to combat COVID-19 are desperately needed.” The Phase 1/2a placebo-controlled study will enroll a total of 60 healthy participants and moderately-ill hospitalized COVID-19 patients. The study has 4 parts: Part A – a single ascending dose part, Part B – a multiple ascending dose part, Part C – a combination part in healthy individuals, and Part D a combination in COVID-19 infected patients. The study is being conducted by Avance Clinical Pty Ltd., a leading Australian clinical research organization. AT-H201 is a proprietary combination of two drugs previously approved by the FDA to treat other diseases and by other administration routes. AT-H201 is intended to be inhaled via a nebulizer to improve compromised lung function for moderate to severely ill, hospitalized COVID-19 patients and for “long-haul” patients with post-infection pulmonary disease. In May 2020, we completed in vitro testing of AT-H201 which showed that the components of AT-H201 inhibit SARS-CoV-2 infectivity of VERO cells, which is a standard cell type being used to study infectivity of the coronavirus.
The Phase 1/2a study in Australia and other clinical studies must be successfully completed and regulatory approvals must be obtained before AT-H201 may be commercialized. No assurance can be given than studies will be successful or that regulatory approvals will be obtained.

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 $40.62, -6.15%.

InMed Pharmaceuticals Inc. (NASDAQ: INM), a leader in the development, manufacturing and commercialization of rare cannabinoids, closed at $1.29, +6.61% after hitting an intraday high of $1.33. Today, Jan. 19, InMed announced that it has launched B2B sales of the rare cannabinoid cannabicitran (CBT) into the health and wellness sector. CBT is the first of several new product launches planned for the first half of 2022. InMed’s subsidiary, BayMedica, has received initial purchase orders and has commenced commercial sales of the ultra-rare cannabinoid CBT. CBT is the second rare cannabinoid to be launched by BayMedica, which also sells CBC wholesale as a raw ingredient to the health and wellness sector. Additionally, commercial scale production of cannabidivarin (CBDV) is underway, with tetrahydrocannabivarin (THCV) production scheduled to follow shortly thereafter. The Company expects to produce over 100kg of CBDV and THCV in the coming months to meet anticipated initial demand. Shane Johnson, SVP and General Manager of BayMedica stated, “We are delivering on our objective to launch additional rare cannabinoids in early 2022 in response to inbound demand. By midyear, we expect to have at least four rare cannabinoids available for the health and wellness markets, positioning us as a leading large scale supplier of high quality rare cannabinoids in these sectors. The launch of CBT further demonstrates our ability to produce rare cannabinoids at commercial scale, an achievement that very few companies have been able to accomplish. We are pleased with initial demand and we expect to grow sales over the coming quarters as we continue to expand our product portfolio of rare cannabinoids.” This emerging market is expected to grow significantly due to the increasing awareness of the potential benefits of cannabinoid-based products. According to the December 2021 Grand View Research report, the retail market for rare cannabinoids is expected to reach US$26 billion by 2028 with a forecasted compounded annual growth rate (CAGR) of >20% during the same period. With the availability of these rare cannabinoids at commercial scale, product manufacturers and consumer brands now have the ability to deliver differentiated products, including augmenting existing CBD-based products, to consumers in the health and wellness marketplace.

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 $9.06, -1.31% after hitting an intraday high of $9.45.

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 $3.42., -7.32%, but still well off of its 52-wk high of $12.30. Maxim Group’s sell side analyst Jason Mccarthy, Ph.D. initiated coverage with a Buy Rating Report titled “INVO Bioscience: Transforming Assisted Reproductive Technology with Intravaginal Culture” with a $7 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 $5.17, +1.77%.

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 $1.87, 10.74% after hitting an intraday high of $2.10. The 52-wk range is $2.10-$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.

Economic Reports

On Tuesday, the Empire State Manufacturing Survey for January confirmed a flop to -.7 (down from 31.9 in December) & the NAHB Housing Market Index for January fell to 83. On Wednesday, the Housing starts report confirmed a rise by 1.4% M/M in December to a seasonally adjusted annual rate of 1.702M. Housing permits also rose 9.1%M/M to 1.873M. The weekly MBA Mortgage Applications Index report confirmed a rise by 2.3%.

Investing & Inspiration

“Infrastructure investment in science is an investment in jobs, in health, in economic growth and environmental solutions.” – Oren Etzioni
“Educating our children and giving them the skills they need to compete in a global economy is a smart investment in our country’s future.” – Sheldon Whitehouse
“Know thy self, know thy enemy. A thousand battles, a thousand victories.” – Sun Tzu
“If one does not know to which port one is sailing, no wind is favorable.” – Lucius Annaeus Seneca
“Beware of missing chances; otherwise it may be altogether too late some day.” – Franz Liszt
“The sofa is a really important investment for anybody, and I don’t mean financially. You need to find a really great sofa that can transition with you, and you can build from there.” – Jeremiah Brent
“There is no investment you can make which will pay you so well as the effort to scatter sunshine and good cheer through your establishment.” – Orison Swett Marden
“Nothing in life is to be feared, it is only to be understood. Now is the time to understand more, so that we may fear less.” – Marie Curie
“There is little that can withstand a man who can conquer himself.” – Louis XIV
“In tennis, you strike a ball just after the rebound for the fastest return. It’s the same with investment.” – Masayoshi Son
“A camel makes an elephant feel like a jet plane.” – Jackie Kennedy
“The advance of technology is based on making it fit in so that you don’t really even notice it, so it’s part of everyday life.” – Bill Gates
“Success depends upon previous preparation, and without such preparation there is sure to be failure.” – Confucius, Chinese
“Coming together is a beginning; keeping together is progress; working together is success.” – Edward Everett Hale
“Never do anything against conscience even if the state demands it.”– Albert Einstein
“Education is not only a ladder of opportunity, but it is also an investment in our future.” – Ed Markey
“The true measure of a man is how he treats someone who can do him absolutely no good.” – Samuel Johnson
“In my view, the biggest investment risk is not the volatility of prices, but whether you will suffer a permanent loss of capital. Not only is the mere drop in stock prices not risk, but it is an opportunity. Where else do you look for cheap stocks?” – Li Lu
“A successful society is characterized by a rising living standard for its population, increasing investment in factories and basic infrastructure, and the generation of additional surplus, which is invested in generating new discoveries in science and technology.” – Robert Trout
“The best preparation for tomorrow is doing your best today.” – H. Jackson Brown, Jr.
“Friendship marks a life even more deeply than love. Love risks degenerating into obsession, friendship is never anything but sharing.” – Elie Wiesel
“Investing in women’s lives is an investment in sustainable development, in human rights, in future generations – and consequently in our own long-term national interests.” – Liya Kebede
“Success isn’t measured by money or power or social rank. Success is measured by your discipline and inner peace.” – Mike Ditka
“No matter how many goals you have achieved, you must set your sights on a higher one.” – Jessica Savitch
“Start where you are. Use what you have. Do what you can.”– Arthur Ashe
“The secret of getting ahead is getting started.” – Mark Twain
“The amount of work and the amount of both physical and emotional investment it takes to get to the top.” – Drew Bledsoe