“A champion is someone who gets up when he can’t.” – Jack Dempsey, American Boxer, June 24, 1895 – May 31, 1983
Tuesday’s markets realized positive moves again today. The S&P 500 achieved a new all-time intraday high moving above the 4.8k mark for the first time ever & the Dow 30 continued advancing. However, more risk oriented stocks took a back seat as tax selling and pairing continued pressuring the Nasdaq, the Russell and the MicroCaps lower. The macroeconomic schedule produced a couple of interesting reports as the S&P Case-Shiller Home Price Index was confirmed to have risen 18.4% Y/Y in October & the FHFA Housing Price Index rose 1.1% M/M in October. The yield curve saw the 2-yr yield close at .75% up 5 basis points & the 10-yr yield finished flat at 1.48%. The U.S. Dollar Index edged higher by .1% to 96.14, gold prices fell to close at $1,807/oz., -$6/oz., silver closed at $23.04, -$.04, Bitcoin (BTC) closed at $47,589.70, -6.67% & oil prices closed up another .6% and above $76 at $76.01/bbl. On a COVID positive move, even though COVID-19 cases are surging in the US, the CDC shortened quarantine time for asymptomatic people who have been exposed to the virus with COVID-19 to 5-days. CDC Director Dr. Rochelle Walensky confirmed the following in a statement
“The Omicron variant is spreading quickly and has the potential to impact all facets of our society. CDC’s updated recommendations for isolation and quarantine balance what we know about the spread of the virus and the protection provided by vaccination and booster doses.” On a sour note,
Bloomberg reported that The U.S. Centers for Disease Control and Protection also has identified 89 cruise ships with Covid-19 cases on Tuesday, nearly all of which have met the threshold for a formal investigation.
In turn, the S&P 500 closed at 4,786.35 (-.10%), even though 7 of the 11 sectors closed in the green with the ‘riveting’ utilities sector moving up +.9% to lead the way & the influential information technology sector closing off .6%. The Dow 30 closed further above the 36k level at 36,398.21 (+.26%) & the Nasdaq slipped to close at 15,781.72 (-.56%). The small caps on the Russell also moved lower closing at 2,246.51 (-.66%), while the micro caps took the largest hit of the day as bids were hard to come by generally for the small guys as the iShares Micro-Cap ETF (IWC) closed at $139.86, -1.11%. The SPDR S&P Biotech ETF (XBI), a barometer of the smaller biotech stocks, dropped again today to close at $113.21, -1.70% after hitting an intraday high of $117.51 in the first hour of trading. The 52-wk range is $106.88 – $174.79.
Tomorrow’s macroeconomic schedule will be busy and bring forward the Pending Home Sales report for November, the weekly MBA Mortgage Applications Index report, and the Advance November reports for Intl Trade in Goods, Retail Inventories, & Wholesale Inventories.
VP WATCHLIST UPDATES
Apple (AAPL) closed at $179.29, -.58% after hitting an all-time intraday high of $181.33.
Tesla (TSLA) closed at $1088.47, -.50% after hitting an intraday high of $,1119. Last week, it was confirmed that Tesla will change its touchscreen available video game and make it so that drivers cannot play it while the car is in motion. According to Bloomberg, Elon Musk recently stated on Twitter that he’s “almost done” trimming his stake in Tesla Inc. hours after telling a satirical website that he already reached his target of reducing his stake in the electric-auto maker by 10%. Musk, now 50 yers old, is the world’s richest person and stands atop the Bloomberg Billionaires Index with a fortune of $260.9B.
The Walt Disney Company (DIS) closed at $155.20, +1.57%. “Spider-Man: No Way Home” is reportedly the first movie in the pandemic era to deliver $1B in box office receipts, which should be a positive sign for the top meme-stock of 2021 AMC Theaters (AMC). Note that Disney owns Spiderman, however Sony (SNE) still controls the suer hero character at the movies. 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 $1.76 prior to closing at $1.66, -2.35% on 4.553M 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 Dec. 13, Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, showcased positive interim Phase 1 data from the Company’s FT596 program for patients with relapsed / refractory B-cell lymphoma (BCL) at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition. FT596 is the Company’s off-the-shelf, multi-antigen targeted, iPSC-derived natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three anti-tumor functional modalities: a proprietary chimeric antigen receptor (CAR) optimized for NK cell biology that targets B-cell antigen CD19; a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor that has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies; and an IL-15 receptor fusion (IL-15RF) that augments NK cell activity. “The interim dose-escalation clinical data from our FT596 program in relapsed / refractory B-cell lymphoma demonstrate that off-the-shelf, iPSC-derived CAR NK cells can bring substantial therapeutic benefit to heavily pre-treated patients in urgent need of therapy, with high response rates and meaningful duration of responses,” said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. “We are particularly pleased with the therapeutic profile that has emerged with FT596 in combination with rituximab, where over half of the patients treated with a single dose of FT596 at higher dose levels achieved a complete response with a favorable safety profile that is clearly differentiated from CAR T-cell therapy. We look forward to assessing a two-dose treatment schedule for FT596 to further define its potential best-in-class therapeutic profile and ability to reach more patients, including those earlier in care.” Shares of FATE closed at $60.15, +3.96%.
InMed Pharmaceuticals Inc. (NASDAQ: INM), a leader in the development, manufacturing and commercialization of rare cannabinoids, closed at $1.35, -4.26% after hitting an intraday high of $1.4201. On Dec. 20, InMed announced that a peer-reviewed scientific article entitled “Cannabinol Modulates Neuroprotection and Intraocular Pressure: A Potential Multi-Target Therapeutic Intervention for Glaucoma”, has been published in Biochimica et Biophysical Acta (BBA – Molecular Basis of Disease), a leading international journal focused on biochemistry and molecular genetics of disease processes and models of human disease in the area of aging, cancer, metabolic-, neurological-, and immunological-based diseases. The peer-reviewed article highlights research evaluating the use of cannabinol, or CBN, as a potential treatment option for glaucoma. Several studies were conducted to evaluate the survival of retinal ganglion cells, modulation of intraocular pressure and its effects on extracellular matrix proteins using in vitro and in vivo glaucoma models. These studies resulted in two key findings: first, CBN may promote neuroprotection of cells in the retina that are responsible for vision; and second, CBN may normalize intraocular pressure by attenuating changes in the extracellular matrix proteins. The article also reports on the comparison of CBN with other cannabinoids, including cannabidiol (CBD) and tetrahydrocannabinol (THC), with results indicating that CBN has a stronger effect and broader neuroprotective therapeutic range. These observations elucidate the therapeutic potential for CBN in the treatment of glaucoma.
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 $1o.32, -1.05% after hitting an intraday high of $10.42.
Shares of INVO Bioscience, Inc. (NASDAQ: INVO), a medical device company focused on commercializing the world’s only in vivo culture system (IVC), INVOcell®, closed at $3.35 and has traded up to $3.50, +4.48% in the aftermarket, 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, -.76%.
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 $2.74, -5.52% after hitting an intraday high of $2.99. The 52-wk range is $2.52-$12.89). On Dec. 23, NeuBase reported its financial results for the fiscal year ended September 30, 2021, and other recent developments. As of September 30, 2021, the Company had cash and cash equivalents of approximately $52.9 million, compared with approximately $32.0 million as of September 30, 2020 NeuBase estimates its current cash and cash equivalents are sufficient to fund currently planned operating and capital expenditures into the first quarter of CY2023. “NeuBase is focused on significantly reducing the burden of untreatable morbidity and mortality caused by rare and common diseases across the globe. To achieve this goal, we designed, built, and validated a new precision genetic medicines platform technology that can uniquely drug the double-stranded human genome and address disease at the root of causality without many of the limitations of early precision genetic medicine technologies. We are poised to file our first Investigational New Drug (‘IND’) applications with the U.S. Food and Drug Administration (‘FDA’) beginning in calendar year 2022 and intend to scale into additional indications with increasing speed and efficiency thereafter,” said Dietrich A. Stephan, Ph.D., Founder, Chief Executive Officer, and Chairman of NeuBase. “This past year, we validated the ability of our technology in proof-of-concept studies to directly drug the double-helix of the human genome, including difficult double-stranded structures of RNA targets, and engage with mutant genes to resolve most causal mechanisms of disease. The validation of our platform’s capabilities included data describing that we have overcome many limitations of early precision genetic medicine technologies, such as biodistribution, tolerability, selectivity, manufacturability, durability, and scalability. We also presented data that our delivery shuttle enables compounds to elicit pharmacologic effects in multiple tissues, including in the brain and muscle, after subcutaneous administration in preclinical animal models,” said William Mann, Ph.D., M.B.A., Chief Operating Officer of NeuBase. “We recently nominated the development candidate for our myotonic dystrophy type 1 (DM1) program, which we believe has the potential to be a best-in-class therapy that offers a patient-friendly route of administration, a whole-body solution for the muscle, heart, and brain manifestations of the disease. Furthermore, the mechanism of action of our development candidate is designed to engage with the toxic RNA hairpin structure to release the splicing proteins, restoring normal RNA splicing and downstream protein production, including DMPK. We have initiated IND-enabling studies for this candidate, with data read-outs expected across CY2022. We expect these data will support the submission of an IND filing to the FDA in the fourth quarter of CY2022,” stated Sandra Rojas-Caro, M.D., Chief Medical Officer of NeuBase. “As a result of the nomination of our DM1 program candidate, we established CMC expertise at our new facility in Cambridge, Massachusetts that is co-located with our clinical development team, finalized the formulation of our development candidate to enable systemic routes, and completed process development. We also scaled-up manufacturing in-house and with contract manufacturing partners to support non-clinical toxicology, product stability, and Phase 1/2 clinical trials,” said Tony Rossomando, Ph.D., Chief Technology Officer of NeuBase. Dr. Stephan concluded, “In parallel, we are making significant progress in our therapeutic program for Huntington’s disease. For example, we have illustrated with preclinical in vivo data that our proprietary delivery technology allows our genome-targeting compounds to advance beyond intrathecal delivery and enabling a systemically administered allele-selective therapy, overcoming challenges seen with other programs. Furthermore, preclinical data show that our PATrOL™-enabled compounds can silence activating KRAS point mutations in vivo to inhibit protein production, which has the potential to target G12D and G12V, the two most common and historically ‘undruggable’ cancer-driving point mutations that represent the majority of KRAS tumors. We believe these data set the stage for a potentially first-in-class precision genetic medicine approach for oncology capable of selectively targeting mutations at the single-base level.”
Shares of Krispy Kreme (DNUT), one of the most beloved and well-known sweet treat brands in the world, closed today at $17.85, +10.05%. Krispy Kreme announced today that “For a doubly delicious start to the new year, Krispy Kreme will “Raise a Glazed” to 2022, offering two Original Glazed® dozens for just $12, Dec. 30 through Jan. 2. The “Raise a Glazed” offer will be available online, via drive-thru and in shop at participating Krispy Kreme locations across the U.S. Guests can purchase up to two dozen per day to sweeten their ringing in of the new year with family and friends. Share how you’re celebrating the start of 2022 with Original Glazed dozens by using #KrispyKreme and tagging @krispykreme. Learn more about Krispy Kreme’s “Raise a Glazed” offer by visiting www.krispykreme.com/offers/raiseaglazed.”
Michael J Tattersfield is President/CEO at Krispy Kreme Inc.
I would like to get the Michael J Tattersfield is President/CEO at Krispy Kreme Inc. on our Tribe Public Network Platform soon for an interview. How about you?
Shares of Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, closed trading at $168.70, +4.71%. On Dec 22, Alnylam announced that the U.S. Food and Drug Administration’s (FDA) approved Leqvio® (inclisiran), the fourth small interfering RNA (siRNA) therapy (or RNAi therapeutic) approved in the U.S., and the first and only to lower low-density lipoprotein cholesterol (also known as “bad cholesterol” or LDL-C). Leqvio is indicated in the U.S. as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of LDL-C. Alnylam scientists discovered inclisiran and published the first clinical data. Alnylam also supported early clinical development. As of January 2020, Novartis has obtained global rights to develop, manufacture and commercialize inclisiran under a license and collaboration agreement. Novartis AG continues to develop inclisiran and commercialize Leqvio worldwide, with Alnylam eligible to receive tiered royalties between 10 and 20 percent on global sales. Leqvio is the fourth Alnylam-discovered medicine using its RNAi therapeutic platform to be approved to date. The Leqvio approval marks the first U.S. approval of an RNAi therapeutic indicated to treat a major risk factor for a highly prevalent disease. Alnylam launched its first RNAi therapeutic in 2018 with the FDA approval of ONPATTRO® (patisiran) for treatment of the polyneuropathy caused by hATTR amyloidosis, a progressive and life-threatening, rare, genetic disease. Leqvio was approved to lower LDL cholesterol and has the potential to benefit millions of people with ASCVD and also those with HeFH around the world.
Today, Winnebago Industries, Inc. (NYSE: WGO), a leading outdoor lifestyle product manufacturer, closed trading at $75, +4.38% and pays a ~1% dividend. On Dec. 17, Winnebago reported financial results for the Company’s Fiscal 2022 first quarter. Winnbego highlighted Record First Quarter Revenues of $1.2 Billion Increased 46%, Including Robust Organic Growth of 38%, Record First Quarter Gross Margin of 19.8% Increased 250 Basis Points Year-Over-Year, Record Reported Quarterly Diluted EPS of $2.90 and Record Adjusted EPS of $3.51, Up 97% Over Prior Year, RV Market Share Gains Continue; 13.3%, or +1.3pp, Trailing Three Months thru October & New Marine Reporting Segment Reflects Expanded Portfolio of Premier Brands with the Acquisition of Barletta.