Quote of the Day – “Life isn’t about finding yourself. Life is about creating yourself.” – George Bernard Shaw
It seemed that just about everyone joined in on the party that was the stock market on hump day as all 11 sectors charged forward. The communication services sector moved up 2.5%, the real estate sector was up 2.4%, & the highly weighted information technology sector powered up 2.3% to strongly lead the markets forward. The continuation and strong move seemed to be powered by a relief of worries. Investors consumed Fauci’s view that the pandemic was getting under control & CNBC’s report that a Fed member believed that inflation may be getting under control. The yield curve also calmed down today from its recent rising nature as the 2-yr yield closed flat at 1.34%, while the 10-yr yield moved lower by 2 basis points to 1.93%. The macroeconomic schedule also delivered the wholesale inventories report which confirmed a 2.2% M/M rise in December & the weekly MBA Mortgage Applications Index dropped by a solid 8.1%. Oil prices also closed at $89.65 ticking up .3% after yesterday’s +2% pullback.
In turn equities were up across the board. The S&P 500 ended at 4,587.18 (+1.45%), the Dow 30 closed at 35,786.06 (+.86%), & the Nasdaq closed at 14,490.37 (+2.08%). The small caps on Russell 2000 also continued to power forward to close 2,083.50 (+1.86%). The party also included a wider group of Microcaps as the iShares Micro-Cap ETF (IWC) closing at $129.45, +1.56%.
The banged up biotech sector was particularly strong again today and continued to wage a comeback, as the SPDR S&P Biotech ETF (XBI), a barometer of the smaller biotech stocks, closed at $97.26, jumping +4.65% after achieving an intraday high of $97.45. The 52-wk range is $83.89- $174.79. Again, it certainly feels like we are finding we are finally finding somewhat solid ground in this sector folks.
Around the money and precious metals’ tree, Bitcoin (BTC) closed at $44,223.78, +.02% over the last 24-hours, gold prices closed at $1,833/oz., +$6/oz. & silver closed at $23.30, +$.10/oz. on the day. Two mining producers also rebounded again today as Hecla Mining Company (HL) closed at $5.27, -.94% and First Majestic Silver Corp. (AG) closed at $10.77, -.09%.
Tomorrow the macroeconomic schedule will produce the following significant reports the Consumer Price Index report for January, the weekly MBA Mortgage Applications Index report, & the Treasury Budget report for January.
FURTHER AFIELD
Shares of troubled Peloton (PTON) continued higher again today, albeit moderately versus its recent skyward daily jumps, to close at $38.77, +4.02%. Rumors continued to fly around that Amazon.com (AMZN) & Nike (NKE) were seeking to buy them out. Yesterday,
Peloton announced a series of steps it is taking to position the business for long-term growth while establishing a clear path to consistent profitability and sustainable free cash flow. Once these actions are fully implemented, the company expects to achieve at least $800 million of annual run-rate cost savings through operating expense efficiencies and significant margin improvement in its Connected Fitness category. The company will also reduce its planned capital expenditures in 2022 by approximately $150 million. The restructuring program is expected to result in approximately $130 million in cash charges related to severance as well as other exit and restructuring activities and $80 million in non-cash charges. The majority of the charges will be recorded in fiscal year 2022.
“Peloton is at an important juncture, and we are taking decisive steps. Our focus is on building on the already amazing Peloton Member experience, while optimizing our organization to deliver profitable growth,” said John Foley, Co-Founder of Peloton and newly appointed Executive Chair.
“With today’s announcements, we are taking action to ensure Peloton capitalizes on the large, long-term Connected Fitness opportunity. This restructuring program is the result of diligent planning to address key areas of the business and realign our operations so that we can execute against our growth opportunity with efficiency and discipline.”
Shares of Harley-Davidson, Inc. (NYSE:HOG) closed at $43.33, jumping another 3.83% after yesterday’s fourth quarter and full year 2021 results report that beat expectations.“Harley-Davidson delivered a strong finish to the year, in which we have seen proof points on all elements of our Hardwire Strategy,” said Jochen Zeitz, Chairman, President and CEO, Harley-Davidson. “Looking ahead, we are fully committed to achieving our long-term Hardwire Strategy, as the most desirable motorcycle brand and company in the world.”
VP WATCHLIST UPDATES
Shares of Apple (AAPL) closed at $176.28, +.83%. Yesterday, Apple® announced that they made history,
landing six Academy Award nominations in several major categories, including Best Picture for “CODA”; Best Actor for Denzel Washington in “The Tragedy of Macbeth”; Best Supporting Actor for Troy Kotsur in “CODA”; Best Adapted Screenplay for writer/director Siân Heder for “CODA”; Best Cinematography for Bruno Delbonnel for “The Tragedy of Macbeth”; and Best Production Design for Stefan Dechant for “The Tragedy of Macbeth.”
On Jan. 27, the tech giant reported a blow out fiscal 2022 Q1 clocking an all-time record with revs of $123.9B, up 11% Y/Y with earnings of $2.10/share. Tim Cook, Apple’s CEO stated, “This quarter’s record results were made possible by our most innovative lineup of products and services ever. We are gratified to see the response from customers around the world at a time when staying connected has never been more important. We are doing all we can to help build a better world — making progress toward our goal of becoming carbon neutral across our supply chain and products by 2030, and pushing forward with our work in education and racial equity and justice. “The very strong customer response to our recent launch of new products and services drove double-digit growth in revenue and earnings, and helped set an all-time high for our installed base of active devices. These record operating results allowed us to return nearly $27 billion to our shareholders during the quarter, as we maintain our target of reaching a net cash neutral position over time,”said Luca Maestri, Apple’s CFO.
Shares of Tesla (TSLA) closed at $932, +1.08%. On Jan. 26, 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. A bargain in the markets is here or on its way it would appear!
The Walt Disney Company (DIS) closed at $147.23, +3.33%. Today,
Disney reported earnings for its first fiscal quarter ended January 1, 2022 beating the street’s estimates. Diluted earnings per share (EPS) from continuing operations for the quarter increased to $0.63 from $0.02 in the prior-year quarter. Excluding certain items(1), diluted EPS for the quarter increased to $1.06 from $0.32 in the prior-year quarter. “
We’ve had a very strong start to the fiscal year, with a significant rise in earnings per share, record revenue and operating income at our domestic parks and resorts, the launch of a new franchise with Encanto, and a significant increase in total subscriptions across our streaming portfolio to 196.4 million, including 11.8 million Disney+ subscribers added in the first quarter,” said Bob Chapek, Chief Executive Officer, The Walt Disney Company.
“This marks the final year of The Walt Disney Company’s first century, and performance like this coupled with our unmatched collection of assets and platforms, creative capabilities, and unique place in the culture give me great confidence we will continue to define entertainment for the next 100 years.”
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 & closing high of $1.47, +3.52% on 3.456M shares of trading volume. On Jan. 27, Atossa issued the annual letter from President and CEO Dr. Steven C. Quay to Atossa stockholders. The letter Bega as follows:
“The last two years have changed the face of public health and uncovered the urgency to develop products not only to prevent widely spread infectious diseases, but to treat them with the same level of focus and dedication applied to prevention. Despite the launch of highly efficacious vaccines during 2021, the toll that COVID-19 was taking on public health was not reduced. The rise of the Omicron variant toward the end of the year, and emerging long-term impact of long COVID, remain an important public health priority, and one that Atossa is dedicated to addressing. A key feature of the original SARS-CoV-2 virus, and that is retained in both the Delta and Omicron variants, is the furin cleavage site found on the Spike protein which facilitates viral infection. Our COVID-19 programs under development are designed to interact with this cleavage site so they are expected to be effective against both current and future COVID-19 variants that continue to contain a furin cleavage site. In the meantime, we are also very excited about the ongoing development of our breast health programs with our proprietary drug Endoxifen, with one Phase 2 study underway and another expected to commence in the next quarter. We raised over $110 million in capital in 2021 and we are well positioned to execute on our programs in 2022.” Click here to read the balance of the letter now.
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.
Shares of FATE closed at $40.95, +3.54%. 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 InMed Pharmaceuticals Inc. (NASDAQ: INM), a leader in the development, manufacturing and commercialization of rare cannabinoids, closed at $1.18., +4.42%.
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, continued higher and closed at $11.39, +3.64%.
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.”
On Feb. 3, INVO announced that effective February 1, 2022, INVO has regained full U.S. commercialization rights to its INVOcell technology, enabling the Company to sell directly into existing IVF clinics, to expand the number of INVO Centers free of any limitations, and to pursue its market expansion strategy focused on increasing access to care and democratizing fertility care for underserved patients. Today, the global fertility market is a multi-billion industry, yet remains severely underserved, with estimates suggesting more than 90% of couples in need of infertility treatment going without care. INVO believes INVOcell and the IVC procedure are well suited to address existing industry capacity challenges and provide an affordable and effective fertility option for patients in need. Mike Campbell, COO and V.P. Business Development of INVO stated, “We are now able to synchronize and take an expanded, more comprehensive and direct approach toward our U.S. commercialization efforts. In addition to supporting and expanding upon the approximate 100 U.S. IVF clinics that have trained on the INVOcell device and the IVC treatment process for their operation, we expect to advance our INVO Center efforts as a critical part of the U.S. strategy moving forward. With our initial three centers now fully operational and focused on delivering INVOcell and the IVC procedure, we are excited to continue rolling out additional centers. As previously noted, we have initially identified over 20 cities in the U.S. as attractive markets. We believe our multi-channel commercial strategy of supporting, servicing, and expanding across the existing IVF clinic network as well as building new, dedicated INVO Centers will help drive increased market awareness of our revolutionary technology, and provide a viable option to help served the large, underserved patient population”
On January 19, 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 $1.49 and have legged up to $1.92, +28.86% in the aftermarkets. The 52-wk range is $1.23-$12.89.
VIEW NOW
On February 3rd, our sister organization, Tribe Public hosted a Webinar Presentation and Q&A Event titled
“Drugging The Genome.” The event was co-hosted by Dietrich A. Stephan, Ph.D, CEO, & Founder of NeuBase Therapeutics (NASDAQ: NBSE). The event video may now be viewed at the
Tribe Public YouTube Channel at this link.
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.