Quote of The Day-
“Nothing is impossible, the word itself says ‘I’m possible’!“
Audrey Hepburn, British – Actress May 4, 1929 – January 20, 1993
The markets started off with a bang today as all indices moved north significantly. There seemed to be a certain understanding in the the air that all was a bit better and the Fed would serve a stock market supportive message. However, as soon as Fed Chair Jerome Powell confirmed that the Fed expects to raise rates as early as March, tapering would end soon, & that they would be discussing a reduction of their nearly $9T balance sheet at the next two meetings, the market began to flop and declined into the close. The Fed also added to the investors’ confusion or distress when it added “At this time, we haven’t made any decisions about the path of policy. I stress again that we’ll be humble and nimble.” The yield curve also moved higher while flattening with the 10-year U.S. Treasury note yield rising to 1.8386% & the 2-year yield moved up to 1.01266%.
With the Fed’s ‘uncertain’ rhetoric floating about the, the large cap indices ended as follows: the S&P 500 closing at 4,349.93 (-.15%), the Dow 30 closed at 34,168.09 (-.38%), & the Nasdaq closed at 13,542.12 (+.02%). The relative strength of the Nasdaq was powered in part by an earnings beat & a rosy outlook served by Microsoft (MSFT, $296.71, +2.9%) after the close yesterday as their Azure is making it the new ‘cloud king’. 9 of the 11 sectors again fueled the overall markets decline with real estate sector dropping 1.7% and the materials sector dropping 1% to lead the way, while the information technology sector rose .7% and the financials sector rose .3%. The small caps on the Russell 2000 did not fair any better today as it closed at 1,976.46 (-1.38%), while the Microcaps also slipped with the iShares Micro-Cap ETF (IWC) closing at $122.91,-1.62%. The banged up biotech sector generally followed the overall markets path again today rising initially and then ending lower as the SPDR S&P Biotech ETF (XBI), a barometer of the smaller biotech stocks dipped to close $88.89 at $89.59, -1.96%. The 52-wk range is $85.31 – $174.79. Again, can we find a bottom in this sector?
Around the money and precious metals’ tree, the U.S. Dollar Index moved up .6% to close at 96.48, Bitcoin (BTC) closed at $6,943.32, +.33% over the last 24-hours, gold prices closed at $1,822/oz., -$28/oz. & silver closed at $23.63, -$.31. Two mining producers also pulled back again today as Hecla Mining Company (HL) fell to $4.94, -5% and First Majestic Silver Corp. (AG) closed at $10.21, -2.85%.
The macroeconomic schedule also delivered the new home sales report jumped 11.9% M/M in December to a seasonally adjusted annual rate of 811k units & new home sales on a Y/Y basis were down 14%. The Advance report for International Trade in Goods for December confirmed a deficit of $101.0B, while the Advance report for Retail Inventories report for December confined a 4.4% rise. The Advance report for Wholesale Inventories report showed a 2.1% increase for December. The weekly MBA Mortgage Applications Index report showed 7.1% drop.
FURTHER AFIELD
Shares of Huadi International Group Co., Ltd. (NASDAQ: HUDI), a leading developer and manufacturer of industrial stainless steel seamless pipes and tubes products in China, jumped 19.81% to close at $19.84. There was no news today. On Nov. 10,
Huadi announced that the Company entered into a strategic cooperation framework agreement on October 28, 2021 with Zhejiang Lanneng Gas Equipment Limited to jointly develop and produce high-pressure hydrogen storage tank stainless steel pipe.
Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company dedicated to delivering targeted therapies for rare cancers, closed trading at $28.64, +26.28% today. Yesterday, Sierra announced positive topline data from the pivotal Phase 3 MOMENTUM study—a global, randomized, double-blind clinical trial evaluating momelotinib (MMB) in myelofibrosis patients who are symptomatic and anemic and previously treated with an approved JAK inhibitor. The trial met all of its primary and key secondary endpoints. Stephen Dilly, MBBS, PhD, President and Chief Executive Officer of Sierra Oncology stated, “These data are extremely exciting and everything we had hoped to see from the trial. To achieve statistically significant and clinically important efficacy across all prespecified primary and key secondary endpoints while maintaining platelet counts in such a difficult to treat patient population is remarkable, and a confirmation of the anemia response we identified in the comprehensive review of our previous Phase 3 studies.” Sierra also announcedthat it intends to offer and sell $100.0 million of shares of its common stock in an underwritten public offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the offering. In addition, Sierra Oncology intends to grant the underwriters a 30-day option to purchase up to $15.0 million of additional shares of its common stock. Sierra Oncology intends to use the net proceeds of the offering to prepare for potential commercialization of momelotinib, clinical development activities of its other product candidates, research, clinical and process development and manufacturing of its product candidates, working capital, and capital expenditures and other general corporate purposes. Jefferies and Cantor are acting as the joint book-running managers for the proposed offering. LifeSci Capital, Oppenheimer & Co. and H.C. Wainwright & Co. are acting as lead managers for the proposed offering.
VIEW NOW
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 $159.69, -.06%.
According Bloomberg, Apple Inc. and Google warned U.S. lawmakers last week 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 $937.41, +2.07%. After the close today Tesla reported adjusted Q4 earnings of $2.54 a share with $17.7B in sales, while operating profit clocked in at $2.6B. Telsa’s free cash flow was registered at $2.8B. Each of those figures represents quarterly records for the company. Tesla’s automotive gross profit margins moved up to 29.2% & it produced a record 305,840 vehicles.
The Walt Disney Company (DIS) closed at $133.601, -2.13%. Last week, to support the ongoing expansion of The Walt Disney Company’s direct-to-consumer business around the world and fuel the expanding pipeline of local and regional content for its streaming services,
the Company announced that it is creating a new hub for international content creation under the direction of Rebecca Campbell as Chairman, International Content and Operations. In addition, the Company is making several key executive appointments to its Disney Media & Entertainment Distribution (DMED) segment under the leadership of its Chairman, Kareem Daniel. 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 $1.35, prior to closing at $1.26, -3.08% on 1.611M 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 $39.27, -1.5%.
InMed Pharmaceuticals Inc. (NASDAQ: INM), a leader in the development, manufacturing and commercialization of rare cannabinoids, closed at $1.09, -4.39% after hitting an intraday high of $1.19. On 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.
Today, Shares of 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, closed at $8.72, -3.11% after hitting an intraday high of $9.45 On Jan. 25, INmune announced that the company has entered into a pre-clinical research collaboration with Chinese University of Hong Kong (CUHK) to evaluate INKmune™ — the company’s pseudokine NK cell priming platform — in nasopharyngeal cancer (NPC), a type of head and neck cancer. The Strategic Partnership Award for Research Collaboration, which was granted by the CUHK Office of Academic Links, is between Prof. Michael Tong at CUHK and Prof. Mark Lowdell at University College London (UCL) and Chief Scientific Officer of INMB. The project provides INMB scientists working at UCL with access to the only three proven NPC cancer cell lines to test the ability of INKmune-primed NK cells to kill NPC tumors.
Prof. Lowdell stated, “Our colleagues at CUHK have been studying NK cell responses to NPC for many years but have not yet translated them into clinical trials. They have shown the need for cytokine activation with IL2 or IL15 to achieve tumor killing. We believe pseudokine activation by INKmune will provide all the relevant NK activating signals of IL2 and IL15 plus a host of other critical NK survival signals and generate memory-like NK cells. We are confident that these INKmune primed cells will kill NPC tumor cells very effectively and we look forward to a mutually beneficial collaboration.”
RJ Tesi, INmune Bio’s Chief Executive Officer stated, “Over 180,000 cases of NPC were diagnosed last year with 85% originating in Asia. Current treatments are quite poor, leading to high mortality rates. History of EBV infection (commonly known as mono) and genetic polymorphisms drive the incidence of the disease. This peer-reviewed grant and international collaboration targeting what has historically been a difficult to treat solid tumor validates the versatility of INKmune. We look forward to translating this work to the clinic in the near future.”
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 $3.06, +1.94% & legged up to $3.43, +8.54% in the aftermarkets, but still well off of its 52-wk high of $12.30. Last week, 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 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 $1.30, -12.16% after hitting an intraday high of $1.51. The 52-wk range is $1.23-$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.