Russell 2000 Smalls Exhibit Strength As Large Caps Falter On Thursday – $FATE $GRAB $INM $INMB $XBI Rise!

 

 

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Shares of  Grab Holding Limited (GRAB), a company that provides superapps that allows access to mobility, delivery, financial services, and enterprise offerings through its mobile application in Cambodia, Indonesia, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam, closed at $3,14, +24.11%. Grab Holdings today announced financial results for the quarter ended March 31, 2022 and highlighted the following: Outperformed Q1 GMV and TPV guidance for deliveries, mobility and financial services, GMV of $4.8 billion, grew 32% year-over-year (“YoY”), Revenue $228 million, up 6% YoY & Loss for the period of $435 million, a 35% improvement YoY. 

Last week, Cytovia Therapeutics, LLC , a global biotechnology company focused on harnessing the power of natural killer (NK) cells to fight cancer through multispecific antibodies and stem cell engineering presented at the AACR Special Conference on Advances in the Pathogenesis and Molecular Therapies of Liver Cancer, held from May 5-8, 2022, at the Westin Copley Place in Boston, Massachusetts. The conference is an in-person event and will not live-stream content, but Cytovia Therapeutics’s short poster video will be available for on-demand viewing by conference registrants after the conference and Cytovia Therapeutics’s poster will be available on its website under the “Resources” section. Learn more. 

 

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.”

 

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Shares of Apple (AAPL) closed at $137.35, -2.46%. Note that Apple enjoys a 6.82% weighting in the S&P 500. On May 17, Apple®  previewed innovative software features that introduce new ways for users with disabilities to navigate, connect, and get the most out of Apple products. These powerful updates combine the company’s latest technologies to deliver unique and customizable tools for users, and build on Apple’s long-standing commitment to making products that work for everyone. Using advancements across hardware, software, and machine learning, people who are blind or low vision can use their iPhone® and iPad® to navigate the last few feet to their destination with Door Detection; users with physical and motor disabilities who may rely on assistive features like Voice Control and Switch Control can fully control Apple Watch® from their iPhone with Apple Watch Mirroring; and the Deaf and hard of hearing community can follow Live Captions on iPhone, iPad, and Mac®. Apple is also expanding support for its industry-leading screen reader VoiceOver with over 20 new languages and locales. These features will be available later this year with software updates across Apple platforms.

 

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.” 

 

 

 

Shares of Tesla (TSLA) closed at $709.42, -.05%. 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. Many are now worried about it sales in China because of the lockdown. 

 

Tesla has plans for another stock split and Elon Musk is also busy buying Twitter (TWTR), but that is on hold currently as the fake accounts issued is resolved…

 

 

The Walt Disney Company (DIS) closed at $103.14, -1.11%. Last week, Disney reported earnings for its second fiscal quarter ended April 2, 2022 missing Ananlyst expectations: Revenue: $19.25 billion vs. $20.11 billion estimate, Adj. earnings per share: $1.08 vs. $1.17 estimate, & Disney+ subscribers: 7.9 million vs. 4.5 million expected. Note that revenues for the quarter and six months grew 23% and 29%, respectively, despite a $1.0 billion reduction for the amount due to a customer to early terminate license agreements for film and television content delivered in previous years in order for the Company to use the content primarily on our direct-to-consumer services. Diluted earnings per share (EPS) from continuing operations for the quarter decreased to $0.26 from $0.50 in the prior-year quarter. Excluding certain items(1), diluted EPS for the quarter increased to $1.08 from $0.79 in the prior-year quarter. EPS from continuing operations for the six months ended April 2, 2022 increased to $0.89 from $0.52 in the prior-year period. Excluding certain items(1), EPS for the six months increased to $2.14 from $1.11 in the prior-year period. Bob Chapek, Chief Executive Officer, The Walt Disney Company stayed, “Our strong results in the second quarter, including fantastic performance at our domestic parks and continued growth of our streaming services—with 7.9 million Disney+ subscribers added in the quarter and total subscriptions across all our DTC offerings exceeding 205 million—once again proved that we are in a league of our own. As we look ahead to Disney’s second century, I am confident we will continue to transform entertainment by combining extraordinary storytelling with innovative technology to create an even larger, more connected, and magical Disney universe for families and fans around the world.”

 

 

 

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 $.9880 prior to closing at $.9570 on 713,042 shares of trading volume. Atossa today announced that Kyle Guse, Chief Financial Officer and General Counsel, will present a corporate overview at the H.C. Wainwright Global Hybrid Investment Conference. The conference is being held on May 23 – 26, 2022 at the Fontainebleau Hotel in Miami Beach, FL.

 

On May 9, Atossa announced the financial results for the fiscal quarter ended March 31, 2022, and provides an update on recent company developments. Key developments from Q1 2022 and to date include: Received issuance of key U.S. patent covering Endoxifen directed to compositions of storage-stable Endoxifen and methods of treating hormone-dependent breast disorders using the storage-stable Endoxifen, Announced planned U.S. Phase 2 clinical study of Endoxifen in the neoadjuvant setting (prior to surgery) to compare Endoxifen to standard of care in premenopausal women with breast cancer. A CRO has been engaged to work on this study and the Company also intends to retain a leading U.S. research institution to help manage the study. The Company anticipates submitting an IND to the FDA in the second quarter of 2022, Completed Part B (second of four parts) of Phase 1b/2a clinical study of AT-H201 in Australia. “We continue to make steady progress with our Endoxifen programs: one to reduce tumor cell activity in breast cancer patients in the neoadjuvant setting; and another to reduce dense breast tissue in women,” commented Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “Our Phase 2 study in women with measurable breast density continues to enroll participants in Stockholm and we have been preparing to submit a request (IND) to the FDA this quarter to open a Phase 2 study in the neoadjuvant setting here in the Unites States. We began 2022 with significant progress in our COVID-19 program, both initiating and completing key parts of our Phase1b/2a trial in Australia for AT-H201, and we have now completed the first two parts of that study.” 

 

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 $22.40, +2.61% after recently 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 $.79/share, +1.28%.

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 $7.43, +2.48%. On May 9, Professor Lesley Probert Ph.D., head of the department of Immunology at the Hellenic Pasteur Institute in Athens, Greece wpresented data on the effects of tumor necrosis factor (TNF) in MS at the 3rd European Conference on Neuroinflammation concluding in London today. Professor Probert has been researching the role of TNF in promoting demyelination (destruction of myelin) for more than a decade. Myelin is a critical component to normal central nervous system function. The myelin sheath, produced by oligodendrocytes, is critical for normal nerve function. When the myelin sheath is damaged, nerve cells cannot transmit signals efficiently and, if the damage persists, the cells undergo neurodegeneration and die. Demyelination is a common feature across many neurodegenerative diseases. A decade ago, Professor Probert’s laboratory showed that in rodent models of MS, XProTM promoted remyelination (the repair of myelin) in white matter whereas currently approved non-selective TNF inhibitors promote demyelination. Her laboratory works to understand why soluble TNF causes demyelination and identifies therapies that promote remyelination. n the presence of neuroinflammation, dysfunctional microglial cells promote nerve cell death, synaptic impairment, and demyelination. The data presented today show that XProTM also promotes remyelination within the gray matter of the brain by inducing the brains natural repair mechanisms. Neutralization of soluble TNF with XProTM activates pro-microglial and pro-astroglial responses to clear (phagocytize) degenerated myelin and promote remyelination in cortical areas. These data are presented in detail here.

 

On May 5, 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. 

 

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 $1.06 and has traded up to $1.15, +8.49% in aftermarket trading. After the market closed today, May 16,  INVO reported financial results for its first quarter 2022, ended March 31, 2022 and highlighted the following: The three INVO Centers in Birmingham, Alabama, Atlanta, Georgia, and Monterrey, Mexico experienced a 40% increase in patient inquiries and consultations compared to the 4th quarter of 2021. This, in part, is the result of our locally targeted marketing efforts and is a positive indicator for potential treatment cycle growth in the coming periods, Announced plans to open additional INVO Centers in Tampa, Florida, and Kansas City, Missouri, in addition to the previously announced planned clinic in the San Francisco Bay Area, Signed an exclusive distribution agreement with Onesky Holdings Limited (“Onesky”) for mainland China (excludes Hong Kong, Macau and Taiwan). The exclusivity is subject to minimum annual purchase amounts over a 5-year term starting upon product registration, the cost of which is to be borne by Onesky, Processed initial product orders from direct sales to U.S. IVF clinics and engaged with approximately 80 clinics, including both new relationships and those already trained on the INVOcell and IVC by Ferring, & Received product orders from our Spain, Pakistan and Nigeria partnerships.

 

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 $1.00, -.99%.  The 52-wk range is $.89-$5.51.

 

On May 17, Neubase announced the presentation of preclinical pharmacokinetics (PK) and biodistribution data for its lead development candidate, NT-0231.F, supporting a differentiated whole body treatment solution for myotonic dystrophy type 1 (DM1). These new data are being presented today in a poster session 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. Following a single intravenous (IV) injection of 30 mg/kg in wild-type BALB/c mice, NT-0231.F was cleared rapidly from the systemic compartment and demonstrated rapid and wide distribution into tibialis anterior muscle, heart muscle, and brain tissues. NT-0231.F rapidly cleared the plasma, and each tissue evaluated displayed an extended elimination phase with tissue concentrations measurable for at least four weeks following a single IV dose administration. Sandra Rojas-Caro, M.D., Chief Medical Officer of NeuBase, said, “We continue to build a robust and compelling data set potentially supporting a whole body treatment solution for DM1. These PK and biodistribution data presented today show IV administration of our lead candidate results in exposure in the major tissues that are affected by DM1. We believe the ability of our drug candidate to reach skeletal and heart muscles as well as brain tissue may potentially deliver a differentiated therapeutic approach to not only treat the myotonia, muscle weakness, and cardiac effects but also the cognitive impairments seen in DM1. We have now demonstrated in preclinical models that our lead candidate NT-0231.F achieves clinically relevant molecular and functional rescue as well as whole-body distribution.”

1. “Life is a series of natural and spontaneous changes. Don’t resist them – that only creates sorrow. Let reality be reality. Let things flow naturally forward in whatever way they like.” – Lao Tzu
2. “The more you praise and celebrate your life, the more there is in life to celebrate.” – Oprah Winfrey
3. “Anything simple always interests me.” – David Hockney
4. “He who angers you conquers you.” – Elizabeth Kenny
5. “Concision in style, precision in thought, decision in life.” – Victor Hugo
6. “The secret of genius is to carry the spirit of the child into old age, which means never losing your enthusiasm.” – Aldous Huxley
7. “View health as an investment, not an expense.” – John Quelch
8. “The most effective way to do it, is to do it.” – Amelia Earhart
9. “Man needs his difficulties because they are necessary to enjoy success.” – A. P. J. Abdul Kalam
10. “Do not dwell in the past, do not dream of the future, concentrate the mind on the present moment.” – Buddha
11. “Nobody made a greater mistake than he who did nothing because he could do only a little.” – Edmund Burke
12. “You must do the things you think you cannot do.”- Eleanor Roosevelt
13. “Success is dependent on effort.” – Sophocles
14. “Nobody who ever gave his best regretted it.” – George Halas
15. “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
16. “And when I breathed, my breath was lightning.” – Black Elk
17. “Moderation is the silken string running through the pearl chain of all virtues.” – Joseph Hall
18. “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
19. “If you want a guarantee, buy a toaster.” – Clint Eastwood
20. “We are an impossibility in an impossible universe.” – Ray Bradbury
21. “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
22. “I’d rather attempt to do something great and fail than to attempt to do nothing and succeed.” – Robert H. Schuller
23. “Do your little bit of good where you are; it’s those little bits of good put together that overwhelm the world.” Desmond Tutu
24. “It takes considerable knowledge just to realize the extent of your own ignorance.” – Thomas Sowell
25. “Do not dwell in the past, do not dream of the future, concentrate the mind on the present moment.” – Buddha”
26. Surprise is the greatest gift which life can grant us.” –  Boris Pasternak
27. “Trust in dreams, for in them is hidden the gate to eternity.” – Khalil Gibran 
28. “Always be yourself, express yourself, have faith in yourself, do not go out and look for a successful personality and duplicate it.” – Bruce Lee
29. “All life is an experiment. The more experiments you make the better.” – Ralph Waldo Emerson
30. “There are no secrets to success. It is the result of preparation, hard work, and learning from failure.” –  Colin Powell
31. “There is more to life than increasing its speed.” – Mahatma Gandhi
32. “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
33. “Definiteness of purpose is the starting point of all achievement.” – W. Clement Stone
34. “Success usually comes to those who are too busy to be looking for it.” – Henry David Thoreau
35. “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
36. “Life is too short for long-term grudges.” – Elon Musk
37. “There cannot be a crisis next week. My schedule is already full.” – Henry Kissinger
38. “Success consists of getting up just one more time than you fall.” – Oliver Goldsmith
39. “The Earth is the cradle of humanity, but mankind cannot stay in the cradle forever.” – Konstantin Tsiolkovsky
40. “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
41. “Beauty surrounds us, but usually we need to be walking in a garden to know it.” – Rumi
42. “But man is not made for defeat. A man can be destroyed but not defeated.” – Ernest Hemingway
43. “Don’t watch the clock; do what it does. Keep going.” – Sam Levenson
44. “Let there be work, bread, water and salt for all.” – Nelson Mandela
45. “The social object of skilled investment should be to defeat the dark forces of time and ignorance which envelope our future.” – John Maynard Keynes
46. “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
47. “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
48. “It is the fight alone that pleases us, not the victory.” – Blaise Pascal
49. “If you can’t describe what you are doing as a process, you don’t know what you’re doing.” – W. Edwards Deming
50. “Never interrupt your enemy when he is making a mistake.” – Napoleon Bonaparte
51. “Be sure you put your feet in the right place, then stand firm.” – Abraham Lincoln
52. “Without investment there will not be growth, and without growth there will not be employment.” – Muhtar Kent
53. “You have to do your own growing no matter how tall your grandfather was.” – Abraham Lincoln
54. “Victory has a thousand fathers, but defeat is an orphan.” – John F. Kennedy
55. “Delete the negative; accentuate the positive!” – Donna Karan
56. “It’s crazy how fast time flies and how things progress.” – Nathan Chen
57. “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
58. “Life isn’t about finding yourself. Life is about creating yourself.” – George Bernard Shaw
59. “Everything has beauty, but not everyone sees it.” – Confucius
60. “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
61. “Walking with a friend in the dark is better than walking alone in the light.” – Helen Keller
62. “A man who dares to waste one hour of time has not discovered the value of life.” – Charles Darwin
63. “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
64. “Progress is man’s ability to complicate simplicity.” – Thor Heyerdahl
65. “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
66. “Nothing is impossible, the word itself says ‘I’m possible’!” – Audrey Hepburn
67. “But investment in space stimulates society, it stimulates it economically, it stimulates it intellectually, and it gives us all passion.” – Bill Nye
68. “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
69. “Life is a tragedy when seen in close-up, but a comedy in long-shot.” – Charlie Chaplin
70. “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
71. “Infrastructure investment in science is an investment in jobs, in health, in economic growth and environmental solutions.” – Oren Etzioni
72. “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
73. “Know thy self, know thy enemy. A thousand battles, a thousand victories.” – Sun Tzu
74. “If one does not know to which port one is sailing, no wind is favorable.” – Lucius Annaeus Seneca
75. “Beware of missing chances; otherwise it may be altogether too late some day.” – Franz Liszt
76. “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
77. “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
78. “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
79. “There is little that can withstand a man who can conquer himself.” – Louis XIV
80. “In tennis, you strike a ball just after the rebound for the fastest return. It’s the same with investment.” – Masayoshi Son
81. “A camel makes an elephant feel like a jet plane.” – Jackie Kennedy
82. “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
83. “Success depends upon previous preparation, and without such preparation there is sure to be failure.” – Confucius, Chinese 
84. “Coming together is a beginning; keeping together is progress; working together is success.” – Edward Everett Hale
85. “Never do anything against conscience even if the state demands it.”– Albert Einstein
86. “Education is not only a ladder of opportunity, but it is also an investment in our future.” – Ed Markey
87. “The true measure of a man is how he treats someone who can do him absolutely no good.” – Samuel Johnson
88. “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
89. “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
90. “The best preparation for tomorrow is doing your best today.” – H. Jackson Brown, Jr.
91. “Friendship marks a life even more deeply than love. Love risks degenerating into obsession, friendship is never anything but sharing.” – Elie Wiesel
92. “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
93. “Success isn’t measured by money or power or social rank. Success is measured by your discipline and inner peace.” – Mike Ditka
94. “No matter how many goals you have achieved, you must set your sights on a higher one.” – Jessica Savitch 
95. “Start where you are. Use what you have. Do what you can.”– Arthur Ashe
96. “The secret of getting ahead is getting started.” – Mark Twain
97. “The amount of work and the amount of both physical and emotional investment it takes to get to the top.” – Drew Bledsoe