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Shares of INmune Bio, Inc. (NASDAQ: INMB), a clinical-stage immunology company focused on developing treatments that harness a patient’s innate immune system to fight disease, closed at $7.09, -5.59% over the last 5-days, but has traded up to $8.35, +17.77% in the aftermarket. The 52-wk range is $6.18 – $30.37.

• • Inmune announced that Professor Lesley Probert Ph.D., head of the department of Immunology at the Hellenic Pasteur Institute in Athens, Greece presented data on the effects of tumor necrosis factor (TNF) in MS at the 3rd European Conference on Neuroinflammation concluding in London in May. 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. In 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 4th, Star Wars Day, 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. Dr. Lowdell, CSO of INmune Bio stated, “For NK cells to become relevant in the treatment of solid tumors, several problems must be solved. At the workshop, we presented how INKmune™, INmune Bio’s NK cell therapeutic, may solve these problems as demonstrated by published and unpublished pre-clinical and clinical data from the INKmune™ Phase I trial in high-risk MDS. A common therapeutic strategy is giving ex vivo-activated NK cells from peripheral blood which are conditioned to normal oxygen levels. Hoping that these cells track to the tumor and aren’t inhibited by the hypoxic, immunosuppressive TME does not align with our understanding of tumor biology in patients. Activation of tumor-resident NK cells in vivo is likely to be important for patient treatment and tumor-activated NK cells seem to be better than cytokine-primed NK cells in surviving the hostile hypoxic and immunosuppressive environment of the TME. As far as we know, INKmune™ is the only agent which can give the pleiotropic NK activating signals that improve NK function in the hostile immunosuppressive and hypoxic environment of the TME. I came away from this meeting even more convinced that INKmune™ can have a major impact in current and future NK immunotherapies in hematological and solid tumors and with a list of potential new collaborators for our future trials.”  

• • 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 InMed Pharmaceuticals, Inc. (NASDAQ: INM), a leading clinical-stage pharmaceutical company developing cannabinoid-based drug candidates for high unmet medical needs and IntegraSyn, a proprietary and cost effective manufacturing approach for synthesized rare cannabinoids, closed at $.7724, -6.94% over the last 5-days, but has traded up to $.8431, +9.15% in the aftermarkets on Friday.  Please visit the INM page at our website to learn more and check out the videos section too. The 52-wk range is $.652 – $3.86. 

• • On May 13, InMed announced financial results for the third quarter of the fiscal year 2022 which ended March 31, 2022. Eric A. Adams, InMed President & CEO stated, “The third quarter of fiscal 2022 saw noticeable advancements across all of our programs, including commencing sales of the rare cannabinoids CBDV and CBT as raw ingredients for the health and wellness industry. For the remainder of fiscal 2022, we will remain focused on driving our commercial operations by expanding our product portfolio, increasing sales of our existing and new rare cannabinoids, exploring new distribution channels and optimizing our product development and supply chain strategy. We continue to grow revenues and have established a solid platform upon which to build as we commercialize additional high value products. We continue to focus on enhancing our sales and marketing efforts to support increasing demand.” LEARN MORE

  • 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.

  • 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. 

• • On  Feb. 15, Inmed announced the appointment of Gerard (Jerry) P. Griffin III as Vice President of Sales and Marketing at BayMedica, a wholly owned subsidiary of InMed. Mr. Griffin will oversee the commercialization of BayMedica’s health and wellness business including the existing products and the launch of new rare cannabinoid products. Mr. Griffin has a wealth of experience across various markets and with numerous cannabinoid products, and a proven track record as a seasoned sales executive. He has held several senior positions at both privately and publicly held companies including Fortune 500 companies. Most recently, Mr. Griffin was the Vice President of Sales and Business Development at Creo Ingredients, a biotechnology-based ingredient company that produces rare cannabinoids. Prior to Creo, he was the President of a successful wellness company, overseeing all aspects of a business that develops and distributes cannabinoid-based products. With his extensive hands-on experience in the rapidly expanding cannabinoid industry, he brings significant real-world knowledge across the entire value chain to the Company.

  • On Feb. 14, InMed announced financial results for the second quarter of fiscal year 2022 which ended December 31, 2021. They highlighted that they completed the acquisition of BayMedica, a rare cannabinoid manufacturing and commercialization company in the health and wellness sector, they strengthened IP with patent filing for use of rare cannabinoids for the treatment of neurodegenerative diseases, they initiated the commercial rollout of an additional rare cannabinoid, CBT- first of several rare cannabinoid launches planned for the first half of 2022, & they advanced the pharmaceutical drug development programs in EB, glaucoma and neurodegenerative diseases. READ THE BALANCE OF THE RELEASE.

• • On Jan. 19, InMed announced that it has launched B2B sales of the rare cannabinoid cannabicitran (CBT) into the health and wellness sector. CBT is the first of several new product launches planned for the first half of 2022. InMed’s subsidiary, BayMedica, has received initial purchase orders and has commenced commercial sales of the ultra-rare cannabinoid CBT. CBT is the second rare cannabinoid to be launched by BayMedica, which also sells CBC wholesale as a raw ingredient to the health and wellness sector. Additionally, commercial scale production of cannabidivarin (CBDV) is underway, with tetrahydrocannabivarin (THCV) production scheduled to follow shortly thereafter. The Company expects to produce over 100kg of CBDV and THCV in the coming months to meet anticipated initial demand. Shane Johnson, SVP and General Manager of BayMedica stated, “We are delivering on our objective to launch additional rare cannabinoids in early 2022 in response to inbound demand. By midyear, we expect to have at least four rare cannabinoids available for the health and wellness markets, positioning us as a leading large scale supplier of high quality rare cannabinoids in these sectors. The launch of CBT further demonstrates our ability to produce rare cannabinoids at commercial scale, an achievement that very few companies have been able to accomplish. We are pleased with initial demand and we expect to grow sales over the coming quarters as we continue to expand our product portfolio of rare cannabinoids.” This emerging market is expected to grow significantly due to the increasing awareness of the potential benefits of cannabinoid-based products. According to the December 2021 Grand View Research report, the retail market for rare cannabinoids is expected to reach US$26 billion by 2028 with a forecasted compounded annual growth rate (CAGR) of >20% during the same period. With the availability of these rare cannabinoids at commercial scale, product manufacturers and consumer brands now have the ability to deliver differentiated products, including augmenting existing CBD-based products, to consumers in the health and wellness marketplace.

• • On Jan. 5th, InMed issued its Annual Letter to Shareholders from President and CEO Eric A. Adams which stated, “Building on a very strong 2021, we are looking forward to 2022 with the continued advancement of our pharmaceutical drug development programs and, with our acquisition of BayMedica, transitioning to becoming a leading B2B supplier of rare cannabinoids to the consumer health and wellness sector. I’m very excited to provide updates on our progress as we begin to commercialize new products and explore an array of rare cannabinoids for their potential therapeutic applications.” Click here to read the letter. 

• • On Nov. 29, InMed Pharmaceuticals (NASDAQ: INM) received a BUY Recommendation from Raghuram Selvaraju, Ph.D. a sell side analyst at H.C. Wainwright & CO. with a Price Target of $6. His report is titled “Charging After Pharmaceutical-Grade Cannabinoids; Initiating at Buy and $6 PT”.  

• Shares of Natural-Killer cell (NKcell) focused biopharmaceutical firm Fate Therapeutics (FATE) closed at $23.10, -4.62% over the last 5-days. 

• • On May 4, Fate reported 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.”

• • On Jan. 10, Fate announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for FT536, an off-the-shelf, multiplexed-engineered, iPSC-derived, chimeric antigen receptor (CAR) NK cell product candidate. FT536 is derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with four functional elements, including a novel CAR that uniquely targets the α3 domain of the major histocompatibility complex (MHC) class I related proteins A (MICA) and B (MICB). MICA and MICB are stress proteins that are expressed at high levels on many solid tumors. The Company plans to initiate clinical investigation of FT536 as a monotherapy and in combination with tumor-targeting monoclonal antibody therapy for the treatment of multiple solid tumor indications.

  • On Monday, Dec. 13, Fate showcased positive interim Phase 1 data from the Company’s FT596 program for patients with relapsed / refractory B-cell lymphoma (BCL) at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition. FT596 is the Company’s off-the-shelf, multi-antigen targeted, iPSC-derived natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three anti-tumor functional modalities: a proprietary chimeric antigen receptor (CAR) optimized for NK cell biology that targets B-cell antigen CD19; a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor that has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies; and an IL-15 receptor fusion (IL-15RF) that augments NK cell activity. “The interim dose-escalation clinical data from our FT596 program in relapsed / refractory B-cell lymphoma demonstrate that off-the-shelf, iPSC-derived CAR NK cells can bring substantial therapeutic benefit to heavily pre-treated patients in urgent need of therapy, with high response rates and meaningful duration of responses,” said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. “We are particularly pleased with the therapeutic profile that has emerged with FT596 in combination with rituximab, where over half of the patients treated with a single dose of FT596 at higher dose levels achieved a complete response with a favorable safety profile that is clearly differentiated from CAR T-cell therapy. We look forward to assessing a two-dose treatment schedule for FT596 to further define its potential best-in-class therapeutic profile and ability to reach more patients, including those earlier in care.”

• Shares of Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19, closed at closed at $.9594, -3.09% over the last 5-days. 

• • On May 9, Atossa announced the financial results for the fiscal quarter ended March 31, 2022, and provided 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 1/2a placebo-controlled study will enroll a total of 60 healthy participants and moderately-ill hospitalized COVID-19 patients. The study has 4 parts: Part A – a single ascending dose part, Part B – a multiple ascending dose part, Part C – a combination part in healthy individuals, and Part D a combination in COVID-19 infected patients. The study is being conducted by Avance Clinical Pty Ltd., a leading Australian clinical research organization. AT-H201 is a proprietary combination of two drugs previously approved by the FDA to treat other diseases and by other administration routes. AT-H201 is intended to be inhaled via a nebulizer to improve compromised lung function for moderate to severely ill, hospitalized COVID-19 patients and for “long-haul” patients with post-infection pulmonary disease. In May 2020, we completed in vitro testing of AT-H201 which showed that the components of AT-H201 inhibit SARS-CoV-2 infectivity of VERO cells, which is a standard cell type being used to study infectivity of the coronavirus. The Phase 1/2a study in Australia and other clinical studies must be successfully completed and regulatory approvals must be obtained before AT-H201 may be commercialized. No assurance can be given than studies will be successful or that regulatory approvals will be obtained.

• • On Dec. 22, Atossa announced that it has initiated enrollment of its Phase 2 clinical study of oral Z-Endoxifen in Sweden. Participants in the study will be premenopausal women with elevated mammographic breast density, which is an emerging public health issue affecting more than 10 million women in the United States and many more worldwide. “This is an extremely important milestone as it marks the next phase of developing our proprietary Z-Endoxifen,” said Steven Quay, M.D., Ph.D., Atossa’s Chairman and CEO. “This study will help determine the relationship between daily doses of Endoxifen and reduction in breast density and will help us further assess safety and tolerability. We look forward to providing progress updates as they become available.” Physician-Scientist and CEO of Atossa, Steven Quay, MD, PhD, recently published an e-print on his research into a new coronavirus, named BANAL-236, reported by the Institut Pasteur in September 2021. At the time, BANAL-236 was the first bat coronavirus with high homology to SARS-CoV-2 that could directly infect human cells using the same receptor that SARS-CoV-2 uses. The new research reports that BANAL-236 has evolved the ability to infect human cells by an unknown mechanism that violates over 40 years of coronavirus research. The COVID-19 e-print is available here and has also been submitted to Nature. “When I read the paper from the Institut Pasteur and looked at the virus, I immediately assumed there was an error in either the way the sequence was assembled or a mix up in the lab with another virus to explain the infectivity,” Quay said. “I contacted the Institut Pasteur with my findings and was deeply disturbed to learn that there was not, in fact, some simple mistake had occurred to explain things. I now knew we were in uncharted waters with a virus that is missing eight key elements that have been shown, over 40 years of research, to be required for growth.”

• • Recently, Physician-Scientist and CEO of Atossa, Steven Quay, MD, PhD, published an e-print on his research into a new coronavirus, named BANAL-236, reported by the Institut Pasteur in September 2021. At the time, BANAL-236 was the first bat coronavirus with high homology to SARS-CoV-2 that could directly infect human cells using the same receptor that SARS-CoV-2 uses. The new research reports that BANAL-236 has evolved the ability to infect human cells by an unknown mechanism that violates over 40 years of coronavirus research. The COVID-19 e-print is available here and has also been submitted to Nature. “When I read the paper from the Institut Pasteur and looked at the virus, I immediately assumed there was an error in either the way the sequence was assembled or a mix up in the lab with another virus to explain the infectivity,” Quay said. “I contacted the Institut Pasteur with my findings and was deeply disturbed to learn that there was not, in fact, some simple mistake had occurred to explain things. I now knew we were in uncharted waters with a virus that is missing eight key elements that have been shown, over 40 years of research, to be required for growth.”

• • On Dec. 6, Atossa announced that it has completed a pre-investigational new drug (PIND) meeting with the FDA. The purpose of the meeting was to obtain input from the FDA on pre-clinical, clinical, manufacturing and regulatory matters in the U.S. for Atossa’s proprietary Z-endoxifen to treat breast cancer in the neoadjuvant (prior to surgery) setting. “Holding a PIND meeting is a critical milestone in the regulatory pathway,” said Dr. Heather Fraser, Atossa’s VP Clinical, Regulatory and CMC. “The feedback we received will be very helpful in preparing our request to the FDA to open an IND for a multi-center Phase 2 study to further advance our Z-endoxifen in the neoadjuvant setting. We plan to focus our development on pre-menopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer for whom the current treatment options typically include drugs that suppress ovarian function and essentially force the patient into menopause. We look forward to opening an IND in the second quarter of 2022 and then commencing a Phase 2 study in this setting. Despite the uncertainties and challenges created by the worldwide, COVID-19 pandemic in 2021, it is gratifying to be able to announce this major step forward for our proprietary Z-endoxifen program development in the U.S., the largest market for pharmaceuticals for the treatment of breast cancer,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “The guidance from this meeting with the FDA, together with the ongoing non-clinical studies with Z-endoxifen and the initiation of a technology transfer process to establish a commercial cGMP manufacturing supplier to support the further drug development and ultimate commercial launch of Z-endoxifen, will put Atossa in an excellent position to continue the development of Z-endoxifen in 2022.” Based in part on the feedback received from the FDA and subject to its approval, Atossa’s current plan, is to continue developing Z-endoxifen for the treatment of pre-menopausal women with ER+/HER2- breast cancer in the neoadjuvant setting. Atossa plans to apply to the FDA for an IND to conduct a Phase 2 study in the U.S. to compare Z-endoxifen to standard of care, which is typically ovarian functional suppression along with either an aromatase inhibitor or tamoxifen. Atossa also plans to conduct a pharmacokinetic run-in study as a part of the Phase 2 study to further define potential dose levels.

• Shares INVO Bioscience (NASDAQ: INVO), a medical device company focused on creating alternative treatments for patients diagnosed with infertility and developers of INVOcell®, the world’s only in vivo Intravaginal Culture System, closed at $1.05.

• • After the market closed, 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.

• • On May 16, INVO announced that they 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 exhibited at the INVOcell solution at the 2022 Pacific Coast Reproductive Society (PCRS) Annual Meeting, taking 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 will both be 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.