The Stock Market Sinks On Cinco De Mayo – $DIA $QQQ $SPY $VIX

Fresh off the Fed’s decision to raise interest rates and the markets surge in the backside of yesterday’s session, the stock market proceeded to sink throughout the Cinco De Mayo Day session with a little relief towards the end of the day. The S&P 500 closed at 4,146.87 (-3.56%), the Dow 30 also closed at 32,997.97 (-3.12%) & the Nasdaq nosedived to close at 12,317.69 (-4.99%), which was the worst move amongst the major indices. It was a perfectly ugly as 11 for 11 sectors closed in the red led by the 5.8% dump of the consumer discretionary sector. The small caps on the Russell 2000 also performed terribly and closed at 1,866.63 (-4.28%).  The MicroCaps moved down as well as the iShares Micro-Cap ETF closed at $115.48, -3.77%. The CBOE Volatility Index or Vix blew up +24.67% to close at $31.69 & back above the key $30 support level.

The macroeconomic schedule helped spearhead the fear of rampant inflation that help lead to the markets demise today as the weekly initial claims report showed jobless claims for the week ending April 30 rising by 19k to 200k , while continuing claims for the week ending April 23 fell by 19k to 1.384M a multi-decade low (think 1970).  The Nonfarm business sector labor productivity report also showed 7.5% drop in Q1, while unit labor costs skyrocketed 11.6% 

The much beleaguered biotech sector got back to its losing ways as the SPDR S&P Biotech ETF (XBI), a barometer of the smaller biotech stocks, closed at $73.85, -6.02% after achieving an intraday high of $77.95 and hitting a new daily 52-week low of $72.50. The 52-wk range is now $72.51 – $141.50. The iShares Biotechnology ETF (IBB) also closed at $117.36, -3.69% after hitting a session high of $120.29. The 52-range is $115.35 – $177.37.   

Around the money and precious metals’ tree, the U.S. Dollar Index backed off again today to close at 103.51, +.90% & Bitcoin (BTC) closed at $36,368.79, -8.60% over the last 24-hours.  Gold prices closed at $1,879/oz., -$6/oz. & silver closed at $22.52/oz., -$.47/oz. on the day. Two mining producers closed the day as follows:  Hecla Mining Company (HL) closed at $5.08, -5.93% and First Majestic Silver Corp. (AG) closed at $9.88, -7.14%.  Hecla will issue a news release reporting its first quarter 2022 financial results before market open on Tuesday, May 10, 2022.

 

 

 

 

On April 26, Isleworth Healthcare Acquisition Corp. (NASDAQ: ISLE) (“Isleworth”), a special purpose acquisition company and Cytovia Holdings, Inc.(“Cytovia”), a biopharmaceutical company empowering natural killer (NK) cells to fight cancer through stem cell engineering and multispecific antibodies announced they have entered into a definitive business combination agreement. Upon consummation of this combination, Isleworth will be renamed Cytovia Therapeutics, Inc. (the “combined company”) and its common stock and warrants are expected to remain listed on NASDAQ under the ticker symbols INKC and INKCW, respectively. “We are grateful for the strong support from new and existing investors and the team of seasoned entrepreneurs at Isleworth. We expect this transaction to accelerate the execution of Cytovia’s vision to advance NK therapeutics towards a cure for cancer” said Dr. Teper. “We are encouraged by our preclinical data recently presented at AACR, which supports advancing development of our iPSC-derived NK cells (iNK) and Flex-NK™ cell engagers for the treatment of Hepatocellular Carcinoma.”

 

Shares of Apple (AAPL) closed at $156.77, -5.57%.

 

On April 28, Apple announced financial results for its fiscal 2022 second quarter ended March 26, 2022. The Company posted a March quarter revenue record of $97.3 billion, up 9 percent year over year, and quarterly earnings per diluted share of $1.52. “This quarter’s record results are a testament to Apple’s relentless focus on innovation and our ability to create the best products and services in the world,” said Tim Cook, Apple’s CEO. “We are delighted to see the strong customer response to our new products, as well as the progress we’re making to become carbon neutral across our supply chain and our products by 2030. We are committed, as ever, to being a force for good in the world — both in what we create and what we leave behind. We are very pleased with our record business results for the March quarter, as we set an all-time revenue record for Services and March quarter revenue records for iPhone, Mac, and Wearables, Home and Accessories. Continued strong customer demand for our products helped us achieve an all-time high for our installed base of active devices,” said Luca Maestri, Apple’s CFO. “Our strong operating performance generated over $28 billion in operating cash flow, and allowed us to return nearly $27 billion to our shareholders during the quarter.” 

 

 Berkshire Hathaway CEO Warren Buffet recently gave praise to Apple CEO Tim Cook in the annual letter to shareholders, while the European Union levied antitrust charges on Apple.

 

 

 

Shares of Tesla (TSLA) closed at $873.28, -8.33%. On April 20, Tesla reported that Q1 sales had jumped 81% even in the face of supply-chain disruptions, while Elon Musk promised a robotaxi for 2024. 

 

Tesla has plans for another stock split and Elon Musk is also busy buying Twitter (TWTR)…

 

 

The Walt Disney Company (DIS) closed at $112.61, -3.08%. On Star Wars Day or May 4th, Disney released a trailer for its upcoming ‘Obi-Wan Kenobi’ series.

 

On April 22, The Walt Disney Company recently announced that it is accepting applications for the 2022 Disney Accelerator, a business development program designed to accelerate the growth of innovative companies from around the world. The program, now in its seventh year, is expected to begin in July and conclude with a Demo Day in the fall. Applications are due by May 13, 2022. Building on Disney’s near century-long history of leveraging technology to deliver unparalleled storytelling and immersive experiences to audiences around the globe, the 2022 Disney Accelerator is open to growth-stage companies with a vision for making an impact on the future of technology and entertainment. Participants will be connected with the creativity, imagination and expertise of Disney and receive exceptional mentorship and guidance from the Company’s leadership team. For this year’s program, the Disney Accelerator team is interested in companies innovating in: artificial intelligence (AI), data and analytics, immersive experiences, machine learning (ML), personalization, robotics, sports tech, and web3. or more information and to apply for participation in the 2022 Disney Accelerator program, visit http://DisneyAccelerator.com.

 

Recently, the Florida Senate passed a bill to eliminate Disney special status and now Florida governor Ron DeSantis signs bill stripping Disney of special tax status after Disney spoke out against Florida law that limits school instruction about gender identity and sexual orientation or the “D’ont Say Gay” bill. Now experts are suggesting that Florida needs Disney World for economic reasons. 

 

The Walt Disney Company will discuss fiscal second quarter 2022 financial results via a live audio webcast beginning at 4:30 p.m. ET / 1:30 p.m. PT on Wednesday, May 11, 2022. Results will be released after the close of regular trading on May 11, 2022. To listen to the webcast, please visit 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 $1.01 prior to closing at $.9721, -5.62% on 1.609M shares of trading volume. Atossa’s Kyle Guse, Chief Financial Officer and General Counsel, will present a corporate overview at the Q2 Investor Summit Conference being held on May 3 – 4, 2022 at the Westin New York Grand Central Hotel.

 

On April 20, Atossa announced it has completed enrolling 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. 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 B of the study was successfully completed and, subject to approval from the ethics committee, we will now proceed to enroll the next group of participants,” said Steven Quay, M.D., Ph.D., Atossa’s CEO and President. “Despite widespread availability of vaccines, many areas of the world are seeing a recent surge in COVID-19 cases. There continues to be a strong need for additional therapies to combat COVID-19.” LEARN MORE. 

 

On March 8, Atossa announced that the U.S. Patent and Trademark office has issued a new patent further strengthening Atossa’s intellectual property in its proprietary therapy Endoxifen, which is under development for breast cancer and other breast conditions. U.S. Patent No. 11,261,151 (the ‘151 Patent) is titled “Methods for Making and Using Endoxifen” and is directed to compositions of storage-stable Endoxifen and methods of treating hormone-dependent breast disorders using the storage-stable Endoxifen. “We are very pleased with the scope and breadth of this new key patent,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “Patents covering the composition of matter of new therapies are critical to protect markets from generic competition. The ‘151 Patent,’ with its estimated expiration in 2038, strengthens our intellectual property estate and should create long-term stockholder value.” Atossa is developing its proprietary Endoxifen in two clinical settings: one to reduce tumor cell activity in breast cancer patients in the neoadjuvant setting, meaning prior to surgery; and another to reduce dense breast tissue in women. A Phase 2 study is currently underway in women with measurable breast density and Atossa plans to submit a request (IND) to the FDA to open other Phase 2 in the neoadjuvant setting in the next quarter. Atossa’s neoadjuvant program is focused on breast cancers that are classified as estrogen receptor positive (ER+). Although there are numerous neoadjuvant treatments for breast cancers that are not ER+, there are few neoadjuvant treatments for ER+ breast cancer which comprises about 78% of all breast cancers. We believe there is a compelling need for therapy with our Endoxifen in this setting. An estimated ten million women in the U.S. have mammographic breast density, or MBD, for which there is no FDA-approved treatment. MBD is an emerging public health issue and studies conducted by others have shown that MBD increases the risk of developing breast cancer and that reducing MBD can reduce the incidence of breast cancer. The American Cancer Society estimates that in the U.S. in 2022, 287,850 women will be diagnosed with breast cancer, 47,550 of which will be under the age of 50 and 43,250 of which will die from the disease.

 

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 1/2 a 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 $27.19, -11.40% after reporting their business highlights and financial results for the first quarter ended March 31, 2022 on May 4th “We have made significant progress across our disease areas, operations, and collaborations in early 2022, including preparing for submission to the FDA of our multi-disciplinary RMAT briefing package to inform pivotal study readiness in relapsed / refractory aggressive lymphoma, as well as our FT596 plus R-CHOP clinical protocol to initiate investigation in first-line patients,” said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. “We are also poised to treat the first solid tumor patient with FT536, our multi-antigen targeted CAR MICA/B NK cell product candidate, and have initiated IND-enabling activities for two CAR NK cell product candidates under our collaboration with Janssen. We look forward to providing clinical updates for our multiplexed-engineered, iPSC-derived NK and T-cell product candidates across our disease franchises in the second half of 2022.”

 

 

 

Shares of InMed Pharmaceuticals Inc. (NASDAQ: INM), a leader in the development, manufacturing and commercialization of rare cannabinoids, closed at $.8930/share, -8.36%.

On May 5, InMed announced that its subsidiary, BayMedica, will be providing rare cannabinoids for use in Radicle Science, Inc.’s Radicle Energy rare cannabinoid study to assess the effects of delta-9 (“d-9”) dominant tetrahydrocannabivarin (“THCV”) on energy, focus/attention, appetite and weight/BMI. BayMedia will be supplying its highly pure d-9 dominant THCV, formulated into a proprietary lozenge manufactured by Trokie. This rare cannabinoid, consumer-based investigation will measure the effects of the Company’s d-9 dominant THCV in a randomized, blinded, placebo-controlled study in up to 900 adult participants aged 21 and older who reside in the United States. The study includes three dosing groups including a placebo group (no THCV), each delivered via Trokie’s proprietary lozenge technology. The study is set to begin participant recruitment in May and will run for a four week period starting in June with results expected during the summer. The study is part of Radicle Science’s large scale investigations into several rare cannabinoids involving up to 10,000 participants in total, the largest of its kind to date.

On April 28, InMed announced the publication of a patent application in North America for several cannabinoid analogs. This patent application has broad claims directed to their molecular structure, uses and methods of manufacturing. Entitled “Cannabinoid Analogs and Methods for their Preparation”, the patent application describes several new cannabinoid-related chemical compounds that have not been previously described. If granted, the broad patent application allows for the creation of several variations of novel cannabinoid compounds, producing a robust library of proprietary new chemical entities (‘NCEs’). Scientists at BayMedica, LLC, InMed’s subsidiary in the US, designed and produced these cannabinoid analogs. These NCEs are expected to offer similar or improved therapeutic effects compared to their parent (naturally occurring) cannabinoid with modifications that may make them preferred candidates to treat specific diseases.

 

On April 21, InMed announced it has launched B2B sales of the rare cannabinoid cannabidivarin (“CBDV”) to wholesalers, suppliers and end-product manufacturers in the health and wellness sector through its US subsidiary, BayMedica LLC. “Ensuring a reliable, large volume source of highly pure, bioidentical CBDV is an important step forward in the health and wellness sector. CBDV has been researched for its therapeutic potential in several disease areas such as autism spectrum disorder,” said Shane Johnson, MD, SVP and General Manager of BayMedica. “Whether you are a researcher or product developer at a multinational consumer package goods (‘CPG’) company, the ability to access highly pure and consistent active ingredients, free from contaminants typically found in plant-sourced cannabinoids such as pesticides, heavy metals, or potentially even THC, is a fundamental requirement. BayMedica’s cannabinoid manufacturing technologies provides exactly that value and we are excited to continue to introduce to the market additional rare cannabinoids that have previously not been abundantly accessible, including adding THCV to our portfolio in the immediate future.” LEARN MORE.

 

Per an sec.gov Form 4 filing Eric Adams, CEO of InMed purchased 8,650 shares of INM stock at $.85 on April 13, 2022. In addition, another Form 4 filing confirmed that Eric Adams, CEO of InMed also purchased 14,160 shares of INM stock at $.894 on April 14, 2022. He now owns a total of 59,003 shares. 

 

InMed Company’s executive team will be participating in several investor events throughout April and May 2022. LEARN MORE.

On March 17, InMed announced that its Chief Financial Officer, Mr. Bruce Colwill, will be retiring and will be stepping down from his position at the Company effective March 31, 2022. Mr. Colwill will continue to serve as an advisor through June 30, 2022 to facilitate a smooth transition. Ms. Brenda Edwards has been appointed as Interim Chief Financial Officer of the Company effective April 1, 2022. The Company has initiated a search for a full time replacement. Ms. Edwards brings over 35 years experience to InMed including over 20 years as a Chief Financial Officer of both private and public companies. Her experience includes merger and acquisitions, financings, managing high growth situations and financial reporting. She is a member of both the American Institute of CPAs and the Chartered Professional Accountants of Canada.

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.

 

 

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 $7.23, -8.48%. INMB reported its financial results for the quarter ended March 31, 2022 and provided a business update. The company highlighted that they had dosed the first Phase 2 Mild Alzheimer’s Disease Patient with Xpro1595, Presented Data from Ongoing INKmune™ Studies Suggesting Increased NK Cell Treatment Effective Against Solid Malignancies, & $66.7 Million in cash as of March 31, 2022. READ the entire release. 

 

INMB management participated at the B. Riley Neuro & Ophthalmology Conference held virtually on April 28, 2022.

 

On April 13, INmune bio announced dosing of the first patient enrolled in its Phase 2 trial using XPro1595 (XPro™) to treat neuroinflammation as a cause of Alzheimer’s disease (AD). The Phase 2 multicenter, international trial is a blinded, randomized, placebo-controlled six-month Phase 2 trial designed to evaluate XPro™ to treat cognition and function in patients with mild AD and biomarkers of inflammation. The company plans to enroll patients at sites located near major metropolitan areas in Australia, in Canada and in the United States. “The Phase 1 study data clearly showed an improvement in multiple biomarkers related to AD pathology, including a reduction in neuroinflammation and neurodegeneration, and an improvement in biomarkers of neurorepair and neuron communication,” said Dr. C.J. Barnum, INmune Bio’s Vice President of CNS Development. “This Phase 2 study will determine whether improvement in these biomarkers translates into a clinical benefit of improved cognition and function in patients with mild AD and biomarkers of inflammation.”

 

On April 11, INmune Bio announced data demonstrate that INmune Bio’s INB03 reverses MUC4 experssion in HER2+ BC cell line (JIMIT-1) to re-establish sensitivity to trastuzumab (traz) and tyrosine kinase inhibitors (TKI). Mucin 4 (MUC4), a glycoprotein is an easily measured biomarker in women with breast cancer. Previously, INmune Bio reported MUC4 expression predicts worse survival in women with HER2+ BC (p≤0.04). Study results show this new evaluation focused on the effects of MUC4 expression on the immune cells of the tumor microenvironment (TME) in HER2+ BC. These data were presented here today at the American Association of Cancer Research Annual Meeting in 2022, held in New Orleans April 8-13. The findings of this study predict that women with MUC4+/HER2+ BC are expected to have fewer tumor infiltrating lymphocytes (TILs) than women who do not express MUC4 (p=0.018). In a nude mouse model of MUC4+HER2+ BC, the combination of INB03+traz increased the number of activated NK cells (p=0.01) and anti-tumor macrophages (p=0.01) in the TME. In this nude mouse model, anti-tumor macrophage function is more important than NK cell function in controlling tumor growth. Dr. Roxana Schillaci of Instituto de Biología y Medicina Experimental in Buenos Aires stated, “We have previously shown that MUC4 expression correlates with resistance to traz and TKI. We can add third resistance mechanism to the list – an immunologically “cold” TME. These three resistance mechanisms are driven by soluble TNF produced by the tumor and are reversed by INB03 in the animal models.” RJ Tesi MD, CEO of INmune Bio stated, “Resistance to immunotherapy occurs in about a third of women with HER2+ BC. MUC4 is a biomarker of resistance that can be determined from the patient’s biopsy. Identifying a modifiable resistance factor early may allow the clinical team to optimized immunotherapy to improve outcome.”

 

On April 4, INmune Bio highlighted key findings from the NK Cells in Solid Tumors workshop. Dr. Mark Lowdell, INmune Bio’s Chief Scientific Officer (CSO), led the workshop on the role of NK cells in treatment of solid tumors during the Innate Killer Summit in San Diego (March 30 -April 1, 2022). The conference is widely viewed as one of the most important in translational NK cell immunotherapy. Two consistent themes of this year’s conference were the importance of memory-like NK cells and the poor in-vivo survival of adoptively transferred allogeneic NK cells, with or without genetic modification. Strategies to improve NK cell “fitness” and improve NK cell metabolism were at the forefront. NK cell dysfunction and poor survival in the recipient and, in particular the TME may be due to damaged mitochondria – considered the “powerplants” of the cell that are essential for survival. Dr. Lowdell observed that INKmune™, unlike IL15 and other NK-activating cytokines, simultaneously upregulates all mitochondrial survival proteins and more than 40 nutrient receptors on the NK cell. These unique changes may help INKmune-primed NK cells survive and thrive in the hypoxic immunosuppressive TME. Data from patients treated with INKmune™ have shown tumor killing memory-like NK cells present in peripheral blood and bone marrow for at least 15 weeks after INKmune™ therapy and provoked a lot of discussion about whether INKmune™ can be used in combination with adoptive NK therapies to sustain the memory-like phenotype and increase survival.

 

 

 

Since the last Innate Killer Summit, INmune has treated three patients with INKmune™ The first MDS patient, a 74-year-old man, remains stable 9 months after therapy. Updated results at the lowest dose cohort of INKmune treatment at day 119 show: NO side effects – NO evidence of alloresponse to INKmune™, Evidence of disease control and maintenance of MRD after 3 doses, Improved BM function – No G-CSF / Platelet independent, Improved ECOG score from 2 to 0, Production of tumor killing memory like NK cells., & Persistence of activated NK cells in blood to Day 119 at least. The company also reported that a 21-year-old female with relapsed AML and mixed chimerism after stem cell transplant reestablished 100% donor chimerism after INKmune™ therapy. She remains under close observation as an out-patient more than 6 months after INKmune™ therapy. The third patient, a young man with AML who failed two transplants remains desperately ill. “The Innate Killer Summit is the best place to share our data and discuss our pre-clinical and clinical results with the community of scientists developing NK-based immunotherapies”, added Dr Lowdell.

 

On March 25, INMB announced reviews findings from data presented at AD/PD™ 2022 – International Conference on Alzheimer’s and Parkinson’s diseases. The AD/PD™ 2022 International Conference was from March 15-20 in Barcelona, Spain. “The field of AD is changing rapidly as treatments beyond amyloid and tau are explored. Targeting neuroinflammation, the use of biomarkers, and novel clinical trial designs are changing the way drugs are developed for this challenging disease,” said R.J. Tesi, INMB’s CEO. “In my opinion, there are three key observations that put the nine presentations by INmune Bio in perspective. We remain convinced that targeting glial activation with Xpro™ is a smart strategy.”

 

On March 23, eight Form 4’s were filed representing a significant increase in insider buying in INMB’s stock. Please see filings at the direct link at sec.gov. 

 

 

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 $1.7243 after trading up to $1.91 during Thursday’s session.

 

On April 28, INVO announced that in celebration of this year’s National Infertility Awareness Week (“NIAW”), three eligible patients will be granted a full IVC treatment cycle free of charge. The grant program, including patient selection, will be launched in the coming weeks. NIAW is a movement, founded in 1989 by RESOLVE, with a mission to empower patients and help those struggling to build a family. “We are committed to helping people suffering with infertility challenges have access to effective and affordable care,” stated Steve Shum, INVO CEO. “This grant program will benefit selected recipients and is part of our efforts to build awareness and educate patients on INVOcell as an effective and available treatment. We believe our INVOcell technology and the IVC treatment can provide an affordable solution for patients diagnosed with infertility, and can help address key industry challenges regarding cost, capacity constraints and access to care for the large, underserved patient population. We have three operational INVO Centers treating patients in Birmingham, Alabama, Atlanta, Georgia, and Monterrey, Mexico, with others scheduled to open in the San Francisco, Tampa and Kansas City areas later this year. In collaboration with our partners in Atlanta, we are pleased to offer this grant program and encourage people with fertility challenges to reach out to our INVO Center to check eligibility and receive details.” Bloom Fertility, an INVO Center, 6 Concourse Parkway, Suite 250., Atlanta, GA 30328, Ph 678-597-9933, hellobloomfertility.com

 

On April 14, INVO Bioscience announced plans to open an INVO Center in Kansas City, Missouri. The Kansas City 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 others scheduled to open in the San Francisco and Tampa areas. The Company evaluates several criteria and data points as part of its efforts to identify markets suitable for INVO Centers. Based on an analysis of current population statistics, we believe that Kansas City may have upwards of 33,000 patients suffering with Infertility. With an estimated 1,500 IVF treatments annually, there exists a large gap of available care to treat local demand. Similar to other INVO Centers, the Company expects to engage physician partners to support its efforts in the Kansas City market.

 

 

 

INVO Bioscience recently exhibited the INVOcell solution at the 2022 Pacific Coast Reproductive Society (PCRS) Annual Meeting that took place March 23-27 at the Renaissance Esmeralda Resort & Spa in Indian Wells, CA. Chris Myer, INVO’s Senior VP, Business Development, Americas, and Bojan (Bo) Mitrovic, PhD, INVO’s Director, Sales, US both were available in Booth #314 discussing INVOcell with the broader Assisted Reproductive Technology (ART) physician community.
Steve Shum, CEO of INVO Bioscience, commented, “A key component to our go forward commercialization strategy is to synchronize and take an expanded, more comprehensive and direct approach toward our U.S. efforts. PCRS provides us an opportunity to easily connect with a number of U.S. IVF clinics that have already trained on the INVOcell device and the IVC treatment process, as well as introduce our solution to additional clinic operators interested in expanding their treatment options and overall capacity by introducing INVOcell to patients.” Pacific Coast Reproductive Society is a multidisciplinary medical specialty society providing Continuing Medical Education (CME) to physicians and allied healthcare professionals. The PCRS Annual Meeting provides an outstanding forum for the exchange of information and the advancement of the ideologies of reproductive medicine in a relaxed and collegial setting. Session topics have been carefully selected to bring you the highest quality, innovative CME, designed and presented by thought leaders in reproductive medicine.

 

 

 

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.

 

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 $1.0931, -8.91%.  The 52-wk range is $1.06-$5.90.

 

On May 2, NeuBase announced two abstracts have been accepted for presentation at the American Society of Gene and Cell Therapy (“ASGCT”) 25th Annual Meeting, taking place virtually and in person in Washington, D.C., May 16-19, 2022.NeuBase will present new preclinical data on the biodistribution in key tissues of the company’s lead candidate, NT-0231.F, a precision genetic medicine in development to treat myotonic dystrophy, type 1 (“DM1”). NeuBase recently presented data at the 2022 MDA Clinical & Scientific Conference demonstrating that systemic administration of NT-0231.F in the HSALR model achieves clinically relevant molecular and functional rescue, including rescue of the spliceopathy, resolution of nuclear aggregates, and reversal of myotonia (delayed muscle relaxation after contraction). Pharmacokinetic studies of NT-0231.F in wild-type BALB/C mice showed a single IV or SC dose achieved high volume of distribution. The presentations and the full abstracts are available on the ASGCT meeting website.

 

On March 16 and March 17, recently appointed Neubase CFO, Todd Branning (Jan. 10 , 2022),  purchased 10,000 shares of NBSE stock each day for a total of 20,000 shares at $1.62/share and $1.74/share respectively. Here’s the Form 4 filing at the SEC. 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 March 13, Neubase announced new preclinical data for its lead development candidate, NT-0231.F, to treat myotonic dystrophy type 1 (DM1). These data are being presented in poster and oral presentations at the 2022 MDA Clinical & Scientific Conference, which is taking place virtually and in-person in Nashville, Tennessee from March 13-16, 2022. These data was presented at the RNA Leaders World Congress in Basel on March 17th. 

 

Sandra Rojas-Caro, M.D., Chief Medical Officer of NeuBase, said, “DM1 is a significant unmet medical need characterized by myotonia, muscle weakness and wasting, and cognitive impairments. We are excited to present new preclinical data for our lead candidate, NT-0231.F, to support our differentiated approach for DM1. Systemic administration of NT-0231.F achieves clinically relevant molecular and functional rescue in the muscle in the HSALR model, which reproduces many components of the disease. Initial pharmacokinetic data supports a whole-body solution to the disease, and additional preclinical work is in progress to assess biodistribution in key tissues. These data are an important milestone in our DM1 development program and support our pursuit of a best-in-class therapeutic profile for the disease.”

 

A single intramuscular dose confirmed that NT-0231.F is pharmacologically active in the muscle and drives molecular and functional rescue in the HSALR model, including splice rescue, nuclear aggregate resolution, and myotonia (delayed muscle relaxation after contraction) reversal. A single intravenous (IV) dose of NT-0231.F or multiple subcutaneous (SC) doses over a 28-day period broadly rescued splicing, including the chloride channel (Clcn1) transcript, and reversed myotonia in the model. A single IV dose of NT-0231.F provides initial splice rescue at around two weeks, with significant splice rescue around three weeks. Myotonia reversal was achieved at around four weeks, with effects enduring to at least six weeks, the longest time point tested so far. A time course of multiple SC doses across increasing concentrations of NT-0231.F was also investigated and showed splice rescue and myotonia reversal in a dose-responsive manner, illustrating feasibility of the differentiated and patient-friendly SC route. In pharmacokinetic studies of NT-0231.F in wild-type BALB/C mice, a single IV or SC dose showed high volume of distribution, suggesting wide tissue distribution. 

 

Dietrich A. Stephan, Ph.D., Founder, Chief Executive Officer, and Chairman of NeuBase, said, “We now have preclinical data in the gold-standard animal model for our development candidate demonstrating robust reversal of myotonia, as measured by muscle relaxation in these studies. We believe we are the only company that has shown improved muscle relaxation after systemic routes of administration. The HSA^LR model is also a high bar for human disease in that it contains at least 10x more mutant gene CUG- repeat targets than patients, giving us further conviction in the robustness of our approach. Not only does this data support the further advancement of our lead program in DM1 and keep us on track for submitting an Investigational New Drug application to the U.S. Food and Drug Administration in 4Q CY2022, it also validates that we can utilize our PATrOL^TM platform to design novel genetic medicines that target and rescue many other gene dysfunctions, with the potential for clinically impactful outcomes in both rare and common diseases.”

 

 

 

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.

1. “The most effective way to do it, is to do it.” – Amelia Earhart
2. “Man needs his difficulties because they are necessary to enjoy success.” – A. P. J. Abdul Kalam
3. “Do not dwell in the past, do not dream of the future, concentrate the mind on the present moment.” – Buddha
4. “Nobody made a greater mistake than he who did nothing because he could do only a little.” – Edmund Burke
5. “You must do the things you think you cannot do.”- Eleanor Roosevelt
6. “Success is dependent on effort.” – Sophocles
7. “Nobody who ever gave his best regretted it.” – George Halas
8. “Lots of people want to ride with you in the limo, but what you want is someone who will take the bus with you when the limo breaks down.” ~ Oprah Winfrey
9. “And when I breathed, my breath was lightning.” – Black Elk
10. “Moderation is the silken string running through the pearl chain of all virtues.” – Joseph Hall
11. “You are the sum total of everything you’ve ever seen, heard, eaten, smelled, been told, forgot – it’s all there. Everything influences each of us, and because of that I try to make sure that my experiences are positive.” – Maya Angelou
12. “If you want a guarantee, buy a toaster.” – Clint Eastwood
13. “We are an impossibility in an impossible universe.” – Ray Bradbury
14. “If you think in terms of a year, plant a seed; if in terms of ten years, plant trees; if in terms of 100 years, teach the people.” – Confucius
15. “I’d rather attempt to do something great and fail than to attempt to do nothing and succeed.” – Robert H. Schuller
16. “Do your little bit of good where you are; it’s those little bits of good put together that overwhelm the world.” Desmond Tutu
17. “It takes considerable knowledge just to realize the extent of your own ignorance.” – Thomas Sowell
18. “Do not dwell in the past, do not dream of the future, concentrate the mind on the present moment.” – Buddha”
19. Surprise is the greatest gift which life can grant us.” –  Boris Pasternak
20. “Trust in dreams, for in them is hidden the gate to eternity.” – Khalil Gibran 
21. “Always be yourself, express yourself, have faith in yourself, do not go out and look for a successful personality and duplicate it.” – Bruce Lee
22. “All life is an experiment. The more experiments you make the better.” – Ralph Waldo Emerson
23. “There are no secrets to success. It is the result of preparation, hard work, and learning from failure.” –  Colin Powell
24. “There is more to life than increasing its speed.” – Mahatma Gandhi
25. “Your attitude is like a box of crayons that color your world. Constantly color your picture gray, and your picture will always be bleak. Try adding some bright colors to the picture by including humor, and your picture begins to lighten up.” – Allen Klein
26. “Definiteness of purpose is the starting point of all achievement.” – W. Clement Stone
27. “Success usually comes to those who are too busy to be looking for it.” – Henry David Thoreau
28. “In matters of truth and justice, there is no difference between large and small problems, for issues concerning the treatment of people are all the same.” – Albert Einstein
29. “Life is too short for long-term grudges.” – Elon Musk
30. “There cannot be a crisis next week. My schedule is already full.” – Henry Kissinger
31. “Success consists of getting up just one more time than you fall.” – Oliver Goldsmith
32. “The Earth is the cradle of humanity, but mankind cannot stay in the cradle forever.” – Konstantin Tsiolkovsky
33. “Ours is a world of nuclear giants and ethical infants. We know more about war that we know about peace, more about killing that we know about living.” – Omar N. Bradley
34. “Beauty surrounds us, but usually we need to be walking in a garden to know it.” – Rumi
35. “But man is not made for defeat. A man can be destroyed but not defeated.” – Ernest Hemingway
36. “Don’t watch the clock; do what it does. Keep going.” – Sam Levenson
37. “Let there be work, bread, water and salt for all.” – Nelson Mandela
38. “The social object of skilled investment should be to defeat the dark forces of time and ignorance which envelope our future.” – John Maynard Keynes
39. “A successful society is characterized by a rising living standard for its population, increasing investment in factories and basic infrastructure, and the generation of additional surplus, which is invested in generating new discoveries in science and technology.” – Robert Trout
40. “I know not with what weapons World War III will be fought, but World War IV will be fought with sticks and stones.” – Albert Einstein
41. “It is the fight alone that pleases us, not the victory.” – Blaise Pascal
42. “If you can’t describe what you are doing as a process, you don’t know what you’re doing.” – W. Edwards Deming
43. “Never interrupt your enemy when he is making a mistake.” – Napoleon Bonaparte
44. “Be sure you put your feet in the right place, then stand firm.” – Abraham Lincoln
45. “Without investment there will not be growth, and without growth there will not be employment.” – Muhtar Kent
46. “You have to do your own growing no matter how tall your grandfather was.” – Abraham Lincoln
47. “Victory has a thousand fathers, but defeat is an orphan.” – John F. Kennedy
48. “Delete the negative; accentuate the positive!” – Donna Karan
49. “It’s crazy how fast time flies and how things progress.” – Nathan Chen
50. “The world is a dangerous place to live; not because of the people who are evil, but because of the people who don’t do anything about it.” – Albert Einstein
51. “Life isn’t about finding yourself. Life is about creating yourself.” – George Bernard Shaw
52. “Everything has beauty, but not everyone sees it.” – Confucius
53. “A man must be big enough to admit his mistakes, smart enough to profit from them, and strong enough to correct them.” – John C. Maxwell
54. “Walking with a friend in the dark is better than walking alone in the light.” – Helen Keller
55. “A man who dares to waste one hour of time has not discovered the value of life.” – Charles Darwin
56. “The greater danger for most of us lies not in setting our aim too high and falling short; but in setting our aim too low, and achieving our mark.” – Michelangelo
57. “Progress is man’s ability to complicate simplicity.” – Thor Heyerdahl
58. “I like to encourage people to realize that any action is a good action if it’s proactive and there is positive intent behind it.” – Michael J. Fox
59. “Nothing is impossible, the word itself says ‘I’m possible’!” – Audrey Hepburn
60. “But investment in space stimulates society, it stimulates it economically, it stimulates it intellectually, and it gives us all passion.” – Bill Nye
61. “Bitcoin, in the short or even long term, may turn out be a good investment in the same way that anything that is rare can be considered valuable. Like baseball cards. Or a Picasso.” – Andrew Ross Sorkin
62. “Life is a tragedy when seen in close-up, but a comedy in long-shot.” – Charlie Chaplin
63. “No matter what you’re going through, there’s a light at the end of the tunnel and it may seem hard to get to it but you can do it and just keep working towards it and you’ll find the positive side of things.” – Demi Lovato
64. “Infrastructure investment in science is an investment in jobs, in health, in economic growth and environmental solutions.” – Oren Etzioni
65. “Educating our children and giving them the skills they need to compete in a global economy is a smart investment in our country’s future.” – Sheldon Whitehouse
66. “Know thy self, know thy enemy. A thousand battles, a thousand victories.” – Sun Tzu
67. “If one does not know to which port one is sailing, no wind is favorable.” – Lucius Annaeus Seneca
68. “Beware of missing chances; otherwise it may be altogether too late some day.” – Franz Liszt
69. “The sofa is a really important investment for anybody, and I don’t mean financially. You need to find a really great sofa that can transition with you, and you can build from there.” – Jeremiah Brent
70. “There is no investment you can make which will pay you so well as the effort to scatter sunshine and good cheer through your establishment.” – Orison Swett Marden
71. “Nothing in life is to be feared, it is only to be understood. Now is the time to understand more, so that we may fear less.” – Marie Curie
72. “There is little that can withstand a man who can conquer himself.” – Louis XIV
73. “In tennis, you strike a ball just after the rebound for the fastest return. It’s the same with investment.” – Masayoshi Son
74. “A camel makes an elephant feel like a jet plane.” – Jackie Kennedy
75. “The advance of technology is based on making it fit in so that you don’t really even notice it, so it’s part of everyday life.” – Bill Gates
76. “Success depends upon previous preparation, and without such preparation there is sure to be failure.” – Confucius, Chinese 
77. “Coming together is a beginning; keeping together is progress; working together is success.” – Edward Everett Hale
78. “Never do anything against conscience even if the state demands it.”– Albert Einstein
79. “Education is not only a ladder of opportunity, but it is also an investment in our future.” – Ed Markey
80. “The true measure of a man is how he treats someone who can do him absolutely no good.” – Samuel Johnson
81. “In my view, the biggest investment risk is not the volatility of prices, but whether you will suffer a permanent loss of capital. Not only is the mere drop in stock prices not risk, but it is an opportunity. Where else do you look for cheap stocks?” – Li Lu
82. “A successful society is characterized by a rising living standard for its population, increasing investment in factories and basic infrastructure, and the generation of additional surplus, which is invested in generating new discoveries in science and technology.” – Robert Trout
83. “The best preparation for tomorrow is doing your best today.” – H. Jackson Brown, Jr.
84. “Friendship marks a life even more deeply than love. Love risks degenerating into obsession, friendship is never anything but sharing.” – Elie Wiesel
85. “Investing in women’s lives is an investment in sustainable development, in human rights, in future generations – and consequently in our own long-term national interests.” – Liya Kebede
86. “Success isn’t measured by money or power or social rank. Success is measured by your discipline and inner peace.” – Mike Ditka
87. “No matter how many goals you have achieved, you must set your sights on a higher one.” – Jessica Savitch 
88. “Start where you are. Use what you have. Do what you can.”– Arthur Ashe
89. “The secret of getting ahead is getting started.” – Mark Twain
90. “The amount of work and the amount of both physical and emotional investment it takes to get to the top.” – Drew Bledsoe