Quote of the Day – “Don’t watch the clock; do what it does. Keep going.” – Sam Levenson, American Author, December 28, 1911 – August 27, 1980
It was a decidedly rocky and overview sharply downward moving market session after Wednesday’s surge and as the Russia-Ukraine war escalated. The S&P 500 ended at 4,363.49 (-.53%) & the Dow 30 closed at 33,794.66 (-.29%) the Nasdaq closed at 13,537.94 (-1.56%), the small caps on the Russell 2000 closed at 2,032.41 (-1.29%) & the MicroCaps closed lower as the iShares Micro-Cap ETF (IWC) closed at $127.47, -1.04%. However, the yield curved somewhat stayed in place after yesterday’s rise as the 2-yr yield closed at 1.54% up 2 basis points and the 10-yr yield closed at 1.84% down 3 basis points. The banged up biotech sector got a bit more banged up today as the SPDR S&P Biotech ETF (XBI), a barometer of the smaller biotech stocks, closed at $86.65, -2.99% after achieving an intraday high of $89.97. The 52-wk range is $81.71- $149.25. The IBB closed at $124.44,- 1.29.
Oil prices actually closed lower too, but still extraordinarily high at $107.81, -2.9%. Stories related to a possible deal with Iran that could be in place soon with regard nuclear energy were swirling. If this is true, then doesn’t this seem to be a bit of a strange situation?
The macroeconomic schedule also offered the ISM Non-Manufacturing Index report for February which dropped to 56.5%. The Initial jobless claims report for the week ending February 26 fell by 18k to 215k, while continuing claims for the week ending February 19 rose by 2k to 1.476M. The revised Q4 nonfarm business sector labor productivity report confirmed that it had stayed pat at the advance estimate of 6.6%. The Factory orders for manufactured goods report shoed a 1.4% M/M in January (Briefing.com consensus 0.5%) following an upwardly revised 0.7% increase (from -0.4%) in December. Shipments of manufactured goods jumped 1.2% after increasing 0.7% in December. The final IHS Markit Services PMI report for February confirmed a drop to 56.5.
Around the money and precious metals’ tree, the U.S. Dollar Index moved by .4% to close at $97.74, Bitcoin (BTC) closed at $42,562.83, -3.32% over the last 24-hours, gold prices closed at $1,938/oz., +$7/oz. & silver closed at $25.28, -$.05/oz. on the day. Two mining producers closed the day as follows: Hecla Mining Company (HL) closed at $6.66, +2.78% and First Majestic Silver Corp. (AG) closed at $11.85, -1.41%. On Feb. 23, Hecla
announced fourth quarter and full-year 2021 financial and operating results. Phillips S. Baker Jr., President and CEO of Hecla stated,
“2021 was an outstanding year for Hecla as we generated record revenues and adjusted EBITDA resulting in the second highest free cash flow in our 130-year history. The year also positions Hecla for future success with our exploration program delivering our highest silver reserves in more than 20 years and the Lucky Friday’s establishment of a new, innovative mining method that should be both safer and more productive. This method, which we call the Underhand Closed Bench method will allow the Lucky Friday to increase projected production in 2022 by almost a million silver ounces over 2021, which was a million and half more than 2020. Since Hecla is not only the largest producer of silver in the United States but also has the largest silver reserve base in the U.S., our stakeholders are uniquely positioned to benefit from the growing demand for silver in the transition to clean energy.”
Tomorrow, the macroeconomic schedule will offer the Employment Situation report for February.
FURTHER AFIELD
Shares of Chevron Corporation (CVX) closed at $156.22, +1.35%. On March 1, at its annual investor meeting, Chevron reported on its progress to deliver higher returns and advance a lower carbon future. Michael Wirth, chairman and CEO stated, “Chevron’s executing a straightforward strategy, grounded in capital and cost discipline. We’re aiming to grow cash flow and return more of it to shareholders, leveraging our strengths to deliver lower carbon energy to a growing world.” On Feb. 28, Chevron announced that it is acquiring Renewable Energy Group Inc. (REGI, $61.50, +40.38%) for about $3.15B or pay $61.50 per share in an all-cash transaction. The transaction marks a significant boost for the oil giant’s investment in renewable fuels, demand for which is expected to grow in the near future as businesses look for ways to move away from oil and gas to reduce carbon emissions. Renewable Energy, based in Ames, Iowa, is reportedly North America’s largest producer of advanced biofuels and is led by Chief Executive Officer Cynthia “CJ” Warner. It turns feedstock into fuel at more than a dozen locations in the Germany and U.S.
Shares of Pure Storage (NYSE: PSTG), the IT pioneer that delivers the most advanced data storage technology and services, rose +12.79% to close at $29.89. On March 2, Pure Storage announced financial results for its fiscal fourth quarter and full year ended February 6, 2022. Q4 revenue $708.6 million, up 41% year-over-year. Full-year revenue $2.18 billion, up 29% year-over-year. Q4 subscription services revenue $216.0 million, up 42% year-over-year. Charles Giancarlo, Chairman and CEO, Pure Storage stated, “By every measure, Pure had an outstanding quarter and fiscal year. As evidenced by the 41% growth in Q4, our strategy to deliver an innovative portfolio of data storage and services, with industry-leading customer experiences and flexible, efficient operations continues to position Pure as the trusted provider for all organizations.”
VP WATCHLIST UPDATES
Shares of Apple (AAPL) closed at $166.23, -20%. On March 1, Apple (AAPL) confirmed that it has stopped selling Apple products in Russia.
A recent survey points to growing iPhone upgrades in the year ahead. “Overall intent to upgrade to an iPhone has been trending positively with a corresponding drop in intent to purchase competitor phones,” BofA analyst Wamsi Mohan said. “Customer loyalty for Apple remains strong with 67% of current iPhone users intending to buy an iPhone during their next upgrade, which compares to 55% for Samsung, 49% for Huawei and 37% for Xiaomi.”
Daily Journal Chairman and Berkshire Hathaway Vice Chairman Charlie Munger has added to his Apple position of late, their biggest position, stating that “I want big, strong American companies.”
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 $839.29, -4.61%. On Feb. 27,
Barron’s reported that Ukrainian government had asked Tesla CEO Elon Musk to assist with its Starlink stations from SpaceX and he stated on Twitter
“Starlink service is now active in Ukraine. More terminals en route.”
Last week, stories floated that the SEC is looking into whether Tesla’s Elon Musk and his brother Kimbal have violated securities laws when they sold shares late last year. Last week, stories flew around confirming that
Tesla’s Elon Musk has alleged that the SEC was unfairly targeting them with an “endless” and “unrelenting” investigation amid the company leader’s criticism of the government. A lawyer for Musk and Tesla filed a letter with the U.S. District Court in Manhattan accusing the regulator of failing to distribute funds from settlements reached in 2018 over Musk’s tweet that claimed he secured funding to take Tesla private.
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 $145.57, -1.20%. On Feb. 28, Christine McCarthy, Senior Executive Vice President and Chief Financial Officer, The Walt Disney Company, announced that she will participate in a question-and-answer session at the Morgan Stanley Technology, Media and Telecom Conference on Monday, March 7, 2022 at approximately 2:25 p.m. PT/ 5:25 p.m. ET. To listen to the webcast, please visit
www.disney.com/investors.
On Feb. 22, Disney released their
2021 Corporate Social Responsibility Report, which details their efforts to increase diversity, equity, and inclusion through stories and storytellers who reflect the rich diversity of our world, support environmental sustainability by taking action to help protect our planet, and bring comfort, optimism, and joy to our communities through our charitable giving. They also highlight their commitment to investing in our employees and cast members, and to operating responsibly.
On Feb 9,
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 high $1.33 prior to closing at $1.24, -5.34% on 1.75M shares of trading volume. On Feb. 28, Atossa announced their financial results for the fiscal quarter and fiscal year ended December 31, 2021 and provides an update on recent company developments. Dr. Steven Quay, Atossa’s President and Chief Executive Officer stated,
“We continue to make significant progress on our Endoxifen and COVID-19 programs, with the continuation of enrollment of the Australian trial for AT-H201, as well as enrollment in our Swedish Endoxifen Phase 2 trial. We look forward to moving into the next milestones during 2022, and to providing updates on these developing therapies for urgent unmet patient needs. Further, our strong balance sheet will continue to facilitate our development plans as we not only execute on these trials but also explore additional options that could create significant shareholder value.” READ The Balance of the story.
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 Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, closed at $33.05, -5.49%. Fate will present at the following upcoming investor conferences: The Cowen 42nd Annual Health Care Conference available on demand on Wednesday, March 9, 2022 at 11:10 AM ET, the Barclays Global Healthcare Conference available on demand on Wednesday, March 16, 2022 at 11:45 AM ET, & the Oppenheimer 32nd Annual Healthcare Conference available on demand on Thursday, March 17, 2022 at 8:00 AM ET
After the close today, Feb. 28,
Fate Therapeutics reported business highlights and financial results for the fourth quarter and full year ended December 31, 2021. Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics,
“We have begun 2022 with strong clinical and regulatory momentum driving our off-the-shelf, iPSC-derived NK cell programs in relapsed / refractory lymphoma, and look forward to working with the FDA under the Regenerative Medicine Advanced Therapy designation to accelerate therapeutic development in areas of significant unmet need, such as patients who have progressed following autologous CAR T-cell therapy, and to bringing transformative cell therapies to patients in the community setting including as part of early-line treatment. We maintain a strong financial position and are poised in 2022 to achieve key clinical milestones and data read-outs across our wholly-owned disease franchises, to extend our leadership in the manufacture and CMC of iPSC-derived cell therapies with the launch of our second cGMP manufacturing facility, and to bring new multiplexed-engineered NK and T-cell product candidates to patients.”
On Jan. 10, Fate 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 $.882, +1.58% and has traded up to $.95, +7.71% in the aftermarkets.
On Feb. 15, Inmed announced the appointment of Gerard (Jerry) P. Griffin III as Vice President of Sales and Marketing at BayMedica, a wholly owned subsidiary of InMed. Mr. Griffin will oversee the commercialization of BayMedica’s health and wellness business including the existing products and the launch of new rare cannabinoid products. Mr. Griffin has a wealth of experience across various markets and with numerous cannabinoid products, and a proven track record as a seasoned sales executive. He has held several senior positions at both privately and publicly held companies including Fortune 500 companies. Most recently, Mr. Griffin was the Vice President of Sales and Business Development at Creo Ingredients, a biotechnology-based ingredient company that produces rare cannabinoids. Prior to Creo, he was the President of a successful wellness company, overseeing all aspects of a business that develops and distributes cannabinoid-based products. With his extensive hands-on experience in the rapidly expanding cannabinoid industry, he brings significant real-world knowledge across the entire value chain to the Company.
On Feb. 14, InMed announced financial results for the second quarter of fiscal year 2022 which ended December 31, 2021. They highlighted that they completed the acquisition of BayMedica, a rare cannabinoid manufacturing and commercialization company in the health and wellness sector, they strengthened IP with patent filing for use of rare cannabinoids for the treatment of neurodegenerative diseases, they initiated the commercial rollout of an additional rare cannabinoid, CBT- first of several rare cannabinoid launches planned for the first half of 2022, & they advanced the pharmaceutical drug development programs in EB, glaucoma and neurodegenerative diseases.
READ THE BALANCE OF THE RELEASE.
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.
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 $7.81, -6.91%. Today, March 3,
INmune Bio reported its financial results for the year ended December 31, 2021 and provided a business update. INmune Bio highlighted that in December, the Company reported data from the first patient treated with INKmuneTM in the myelodysplastic syndrome (MDS) Phase I clinical trial. More than 100 days after the course of INKmuneTM therapy, 60% of the patient’s NK cells showed the activated, tumor killing memory like NK cells phenotype, a fourfold increase from pre-treatment. The patient’s memory like NK cells killed >70% of NK resistant tumor cells in an in vitro assay. The patient remains well and with an ECOG status of 0, a two-point drop from pre-treatment. Additionally, two patients were treated with INKmuneTM under compassionate use after having failed at least one allogeneic bone marrow transplant. One of the two patients has been discharged home, one remains hospitalized. In all cases, INKmuneTM therapy was well tolerated, safe and was given without any type of pre-medication or cytokine therapy. “These patients demonstrate the unique attributes of INKmuneTM therapy in patients with high-risk MDS/AML. INKmuneTM converted the patient’s resting NK cells into cancer killing memory like NK cells. The memory like NK cells killed NK-resistant cancer cells in an in vitro assay. Both these attributes lasted four months, a trait we are calling therapeutic persistence.” stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. “We are continuing to screen patients for enrollment into the trial and are in process of expanding the number of clinical trial sites.”
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 commercial-stage fertility company focused on expanding access to advanced treatment worldwide with its INVOcell® medical device and the IVC procedure it enables, closed at $2.77 & has traded up to $2.94, +6.14% in after market trading.
On Feb 16, INVO announced plans to open its next INVO Center in Tampa, Florida. The Tampa INVO Center will focus on patients in need of advanced fertility care utilizing the efficient, effective, and affordable INVOcell® solution. The company currently has three operational INVO Centers treating patients in Birmingham, Alabama, Atlanta, Georgia, and Monterrey, Mexico, with another scheduled to open in the San Francisco area. “Following significant diligence and in consultation with industry experts, we are excited to announce Tampa as the next INVO Center location,” commented Steve Shum, CEO of INVO. “The characteristics and demographics of the Tampa market lend themselves perfectly to our INVO Center approach focused on expanding access to advanced fertility services for the significantly underserved patient population. By leveraging the blueprint and experiences from our earlier centers, we look forward to opening the clinic in 2022 and advancing our mission of democratizing fertility care. We are also actively conducting due diligence in several other markets as we look to initiate further expansion of our INVO Center commercialization platform.” The company expects to engage physician partners, similar to the models deployed in its other centers.
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 $1.63 after reaching an intraday high of $1.81 on 192,440 shares of trading. The 52-wk range is $1.21-$9.93.
On Feb. 28,
Neubase announced that new preclinical data from its myotonic dystrophy type 1 (DM1) program will be featured in presentations at the 2022 MDA Clinical & Scientific Conference. MDA 2022 will be taking place virtually and in-person in Nashville, Tennessee, from March 13-16, 2022, and the abstracts will be available on the
meeting website. Expanding upon initial data presented in June 2021, the presentations will include new data of a PATrOL™-enabled investigational genetic therapy for DM1. NeuBase will present molecular and functional pharmacological activity of its DM1 investigational genetic therapy in the HSALR mouse model following single and repeated subcutaneous, intravenous, and intramuscular administration. The HSALR model carry the long repeat (LR) length of the DMPK repeat expansion and recapitulates many aspects of the clinical presentation of DM1. Additional pharmacokinetic data will be presented of NeuBase’s DM1 investigational genetic therapy in wild-type mice demonstrating distribution and pharmacologic activity throughout the body, including the brain and muscle, following systemic administration. Patients with DM1 suffer from cognitive deficits and muscle pathology caused by a trinucleotide expansion in the DMPK gene. NeuBase’s DM1 investigational genetic therapy targets DMPK pre-mRNA with a novel peptide-nucleic acid (PNA) pharmacophore and is designed to selectively engage with the toxic RNA hairpin structure and release the splicing proteins to restore RNA splicing and downstream protein production. The PNA pharmacophore is conjugated to NeuBase’s novel delivery technology that is designed for broad distribution, including into the deep brain, with the potential for a whole body, disease-modifying solution for DM1.
On Feb. 10, NeuBase reported its financial results for the three-month period ended December 31, 2021, and other recent developments. Dietrich A. Stephan, Ph.D., Founder, Chief Executive Officer, and Chairman of NeuBase stated,
“We are making significant progress in advancing the IND-enabling studies for the development candidate for our myotonic dystrophy type 1 (DM1) program, and we expect to file an IND with the FDA in Q4 CY2022. These studies are on track for data readouts to occur throughout CY2022, with the first presentation of rodent pharmacokinetic and bioavailability data to occur at an upcoming scientific meeting. We expect these data to illustrate the differentiated potential for our candidate to be a whole-body solution to treat DM1 and the unique ability of our delivery shuttle for distribution into the brain. The ability to cross the blood brain barrier and reach the deep brain is also especially relevant for our Huntington’s disease program, where we are planning to initiate scale-up and toxicology activities this year. In addition, I’m especially excited to have welcomed Todd to the executive team as Chief Financial Officer. The team and science are strong, and I believe we are at a pivotal moment for NeuBase as we are building a robust data package that is expected to support bringing our first candidate into the clinic for DM1, validate our genetic medicine technology platform to efficiently deliver genetic medicines with broad tissue distribution, including into the deep brain, and to precisely engage genetic mutations in a manner that is well-tolerated with the potential for sustained efficacy.” READ THE BALANCE OF THE RELEASE HERE.
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.