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On Nov. 30,  Atossa Therapeutics’ CEO, Dr. Steven Quay, M.D., Ph.D., and Kyle Guse, GC & CFO presented at our sister organization Tribe Public’s FREE Webinar Presentation and Q&A Event. During this complimentary event, Atossa management addressed Q&A from the Tribe focused on Atossa’s research programs and future development. You can watch the event video titled “A Town Hall Q&A Event With Atossa Therapeutics Management Team” at the Tribe Public YouTube Channel by clicking here. The video has now received over 18k views!

• 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 $12.07, +7.58% this week. The 52-wk range is $7.28 – $30.37.

• • On Dec. 9, INMB announced data to be presented at the San Antonio Breast Cancer Symposium showing mucin 4 (MUC4) expression predicts worse survival and is a treatment resistance factor in women with triple negative breast cancer (TNBC). INB03, a DN-TNF therapy, can reverse TNBC treatment resistance by decreasing expression of MUC4 and reducing immunosuppression in the tumor microenvironment (TME) by increasing anti-tumor macrophage phagocytosis and increasing lymphocyte function in the TME. The poster will be presented by Dr. Roxana Schillaci, Instituto de Biología y Medicina Experimental, Buenos Aires, on December 10th. RJ. Tesi, M.D, Chief Executive Officer of INmune Bio, commented, “We are excited to have Dr. Schillaci present these data that expand on her previous findings on the role of MUC4 expression which predicts worse survival and resistance to therapy in HER2+ breast cancer therapy. Now, in both TNBC and HER2+ breast cancer, MUC4 predicts resistance to immunotherapy and an immunosuppressive TME that can be overcome with INB03.” Treatment with INB03 in murine models of breast cancer improves macrophage anti-tumor phagocytic activity, lymphocyte infiltration and function suggesting improved response to combination therapies of INB03 with inmunotherapy.

  • On Dec. 1,  INmune Bio announced two poster presentations at the 2021 British Society of Immunology Congress, which was held November 28-December 1, in Edinburgh, UK. Mark Lowdell, PhD, Chief Scientific Officer of INmune Bio, stated, “I’m delighted to have two of our team presenting our latest data on the mechanism of action of INKmune. These are the first comprehensive data showing that INKmune-mediated priming generates NK cells with memory-like phenotype (mlNK). Before this, mlNK cells could only be produced using multiple combinations of cytokines. These are the data which led us to the concept that INKmune is a ‘pseudokine’ that provides multiple signals to NK cells, akin to the multi-cytokine cocktails used by others. We also show that INKmune priming promotes significant proliferation of mlNK cells in vitro. These in vitro data have been replicated in the first patient treated with three, weekly doses of INKmune for high risk MDS. At 119 days post first treatment, 60% of the patient’s NK cells showed the activated, tumor killing phenotype compared to fewer than 15% before INKmune therapy. The patient remains well and with a significantly improved ECOG status.”

• • Recently, INMB presented multiple poster presentations and a plenary talk at the 14th Clinical Trials on Alzheimer’s Disease (CTAD) Annual Meeting that was held from November 9-12 in Boston. Learn more. 

• • The Maxim Group’s analyst Jason McCarthy confirmed his $42 Price target recently.  

• • On Nov. 3rd, INmune Bio (NASDAQ: INMB), a clinical-stage immunology company focused on developing treatments that harness a patient’s innate immune system to fight disease, reported its financial results for the third quarter ended September 30, 2021 and provided a business update including the announcing of a second Phase 2 trial of XPro in Mild Cognitive Impairment (MCI) in addition to previously announced Phase 2 trial in mild Alzheimer’s disease (AD) & Cash and cash equivalents of $84.5 million on September 30th. RJ Tesi, M.D., Chief Executive Officer of INmune Bio stated, “In the first patient treated in our Phase I study of INKmune™ in high-risk myelodysplastic syndrome, INKmune™ was found to safely produce cancer killing memory-like NK cells while increasing proliferation and persistence of those NK cells. As expected, the memory-like NK cells generated in vivo killed NK-resistant cancer cells in vitro. We now have data from Day 73 post first treatment and over 60% of his peripheral blood NK cells remained activated and highly functional in vitro. We are continuing to screen patients for future enrollment and are in the process of expanding the number of clinical trial sites in the UK and overseas. Our latest drug stability data allows us to extend the shelf-life to over 12 months and consequently we initiated a manufacturing scale up to secure drug supplies as the program expands. In our Phase I trial of XPro in AD, we have shown that XPro decreases biomarkers of neuroinflammation and neurodegeneration while improving biomarkers of CNS repair. We hope to demonstrate these effects on cognition in the Phase II mild AD trial that is on track to initiate later this year.” INmune Bio announced that they will deliver multiple poster presentations and a plenary talk at the upcoming 14th Clinical Trials on Alzheimer’s Disease (CTAD) Annual Meeting that is being held during November 9-12 in Boston. For details please visit the following link. 

• • I hosted a FREE Tribe Public Presentation and Q&A event with INMB management, Thursday, September 30 at 8:30am PT/11:30am ET. INmune Bio’s (NASDAQ: INMB) CEO Dr. Raymond J. Tesi, MD and CFO David J. Moss delivered their presentation titled “Improving White Matter Integrity In Alzheimer’s Disease” & and were available for a brief Q&A session. Please view the video that has been viewed over +30k times now to learn more.

• • On Wednesday, Sept. 1, INMB announced that XPro™ (pegipanermin), the Company’s selective DN-TNF inhibitor candidate for the treatment of Alzheimer’s disease (AD), treatment resistant depression, and other neurological diseases where neuroinflammation is implicated, has been found to decrease multiple species of Phospho Tau (pTau) and improve neuroimaging biomarkers of myelination in patients with AD. INmune Bio management will host an investor webinar to review these findings and additional phase 1b data in greater detail on September 7, 2021 at 4:30 pm ET The Registration Link is https://us06web.zoom.us/webinar/register/WN_IlMwrkPGRa63319QM91YFg. Learn more bout INmune Bio (INMB) by clicking here.

• • On Wednesday, Aug. 4th, INmune Bio, Inc. reported its financial results for the second quarter ended June 30, 2021 and provided a business update. Raymond J Tesi, M.D., CEO/CMO of INmuneBio (INMB) stated, “We continue our planning and setup for a Phase 2 clinical trial of our lead candidate, XPRO™ (Xpro1595™), in patients with mild Alzheimer’s disease, which we plan to initiate by year-end. We have already demonstrated that XPRO™ can reduce neuroinflammation and decreases biomarkers of neurodegeneration and improve synaptic function. If successful in Phase 2, we believe XPRO™ has the potential to be among the most significant advancements in the treatment of Alzheimer’s Disease (AD) and other neurodegenerative diseases in many years. At the Alzheimer’s Association International Conference last week, we introduced a new biomarker – Apparent Fiber Density (AFD), a measure of axonal integrity measured by MRI. XPRO™ increases AFD in patients receiving 1mg/kg/week. We believe the novel non-invasive white matter analytics of white matter free water and apparent fiber density will be very useful in the development of XPRO™ in AD, Treatment Resistant Depression (TRD) and the many other CNS indications we hope to attack in the future. Last month, we treated the first patient in the first Phase 1 clinical trial of our NK cell priming platform, INKmune, in high-risk myelodysplastic syndrome (MDS). We are calling INKmune a pseudokine because, in vitro, it converts the resting NK cells into memory-like NK cells that can kill cancer cells as well or better than NK cells treated cytokines such as IL-12, IL-15 and IL-18 alone or in combination.”

• • On July 26th, INmune Bio announced the design of its upcoming Phase 2 clinical trial of XProTM in patients diagnosed with mild Alzheimer’s disease (AD) at AAIC. The announcement was accompanied by the release of additional biomarker data from the Phase 1b AD trial that shows improvement in white matter (myelinated axons) that degenerate in AD patients. READ MORE. 

• • On July 22, LUMICKS, a leading next generation life science tools company renowned for its innovative platforms for Dynamic Single-Molecule and Cell Avidity analysis, announced that it has installed its ground-breaking z-Movi® Cell Avidity Analyzer at INmune Bi0. INmune Bio is employing the z-Movi cell avidity analysis platform to demonstrate that the mechanism of action of the tumor-priming is the increase in NK cell:tumor cell avidity. Early data acquired by the z-Movi support their hypothesis that increased cell avidity enhances NK cell killing of tumor cells. This allows screening of batches of INKmune for potency and provides a potential biomarker of in vivo activity by measuring the tumor avidity of NK cells isolated from patients before and after INKmune treatment.

• • On July 14th, INmune Bio announced that it has entered into a definitive agreement with one healthcare focused institutional investor and one family office for the purchase and sale of 1,818,182 shares of its common stock at a price of $22 per share for gross proceeds of approximately $40 million in a registered direct offering. The closing of the offering is expected to occur on or about July 16, 2021, subject to the satisfaction of customary closing conditions. A.G.P./Alliance Global Partners is acting as the sole placement agent for the offering. INmune Bio intends to use the net proceeds from this offering for working capital and general corporate purposes and to advance the development of its product candidates and expand its pipeline. This includes the completion and data readout from the Company’s planned Phase 2 clinical trial of its lead clinical candidate, XPro1595, in patients suffering from Alzheimer’s disease, which is expected to commence by the end of 2021. “With this investment, we expect the Company’s Phase II program in Alzheimer’s disease is completely funded” said RJ Tesi MD, CEO of Inmune Bio.

• • On July 12th,  INmune Bio, Inc. announced that the first patient has been treated in the company’s Phase 1 clinical trial of its Natural Killer (NK) cell priming platform, INKmune, as a potential treatment for high-risk myelodysplastic syndrome (MDS). This Phase 1 open label study will enroll nine patients with a confirmed diagnosis of MDS with excess blasts in a 3×3 dose escalation protocol. The primary endpoint is the safety and tolerability of INKmune when administered intravenously. Most secondary endpoints are biomarkers and include the change in percentage of blasts in peripheral blood and bone marrow, the change in autologous NK cell activity and functional maturity into tumor-induced memory-like NK cells in vivo. The overall response rate using WHO criteria, and duration of response will also be reported. READ MORE.

• • On June 14th, INMB announced that it had entered into a new $15M credit facility with Silicon Valley Bank (SVB) and an affiliate of SVB Financial Group. INmune intends to use the proceeds from the facility to partially fund the buyout of an option held by Xencor, Inc.(XNCR), resulting from INmune’s in-licensing of XPro1595 (now known by its generic name, pegipanermin) in October 2017. XPro1595 is a next-generation inhibitor of tumor necrosis factor (TNF) that uses a dominant-negativeTNF technology that is very different from approved TNF inhibitors that block the effects of both soluble and trans-membrane TNF. Pegipanermin neutralizes soluble TNF, without affecting trans-membrane TNF or TNF receptors. XPro1595 could have substantial beneficial effects in patients with Alzheimer’s and other neurodegenerative diseases by decreasing neuroinflammation. Total consideration to be paid to Xencor by INmune is $18.3 million, comprised of $15 million of cash and $3.3 million of INMB shares at a price of $17.14 resulting in the issuance of 192,533 shares. Pursuant to the original 2017 in-licensing agreement, INmune granted Xencor an option to purchase an additional number of shares of common stock equal to 10% of INmune’s fully diluted company shares for a period of seven years. The retirement of the Xencor option eliminates an estimated 2.1 million shares of potential future common stock dilution upon exercise of the option.

• • On June 2nd, the United States Adopted Name Council (USAN) has adopted the name “Pegipanermin” for INMB’s lead clinical candidate, XPro1595.

• 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 $1.50, +2.04% this week.

• • Please visit the INM page at our website to learn more and check out the videos section too. The 52-wk range is $1.2545 – $8.94. 

• • 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”.  

• • On November 10, InMed announced their financial results for the first quarter of fiscal year 2022 which ended September 30, 2021. “The first quarter of fiscal 2022 saw positive momentum across all of our programs,” says Eric A. Adams, InMed President & CEO. “With the completion of the BayMedica Inc. (“BayMedica”) acquisition, our integrated teams are working together to identify rare cannabinoids in BayMedica’s pipeline for commercialization in the consumer health and wellness industry. For the duration of fiscal year 2022, we will be focused on growing revenues through the launch of these selected rare cannabinoids, in addition to expanding sales of BayMedica’s Prodiol® CBC (cannabichromene) and progressing our existing programs.”

• • On November 3, InMed announced that it has filed an international patent application demonstrating neuroprotection and enhanced neuronal function using a rare cannabinoid for the potential treatment of neurodegenerative diseases such as Alzheimer’s Disease, Parkinson’s Disease, Huntington’s Disease and others.

• • On October 13, InMed announced that they have completed the previously announced acquisition of BayMedica Inc. (“BayMedica”), a private company based in the US specializing in the manufacturing and commercialization of rare cannabinoids for the health and wellness sector. Eric A. Adams, President and Chief Executive Officer of InMed, stated, “We are delighted to close this acquisition and welcome everyone at BayMedica to the InMed team. In the next several weeks, we will focus on corporate integration, exploring our combined manufacturing know-how and looking to accelerate revenue growth. BayMedica brings significant expertise and will help strengthen our pharmaceutical drug development efforts as well as position the Company to become a global leader in the manufacturing of rare cannabinoids.”

• • On September 30, INmed announced that it has commenced its Phase 2 clinical trial of INM-755 (cannabinol) cream in the treatment of Epidermolysis Bullosa (“EB”). This marks the first time cannabinol has advanced to a Phase 2 Clinical trial to be studied as a therapeutic option to treat a disease. This study will be taking place at eleven sites across seven countries including Austria, Germany, Greece, France, Italy, Israel and Serbia. Clinical Trial Applications (“CTAs”) have been filed in all participating countries with regulatory authority and ethics committee approvals currently in place in four countries (Austria, France, Greece, Israel). The first site initiation visit was completed at a clinical site in Austria, where screening for eligible patients will begin shortly. “The start of this Phase 2 clinical trial represents a very important step forward to test the efficacy of INM-755 (cannabinol) cream in treating epidermolysis bullosa, a disease that has very few treatment options,” stated Alexandra Mancini, Senior Vice President of Clinical and Regulatory Affairs at InMed. “Based on our earlier studies, we are hopeful that our cannabinol cream will prove to be a safe and effective treatment for people living with this severe genetic skin disease.”

• • On July 9th, Roth Capital Partners analyst Scott Henry, CFA issued an update report with. BUY Rating titled, “INM: Favorable Take on BayMedica LOI” that includes a $11.50 12-Month Price Target.

• Shares of Natural-Killer cell (NKcell) focused biopharmaceutical firm Fate Therapeutics (FATE) closed at $49.16, +2.42% over the last 5-days. 

• • Fate’s management will host a virtual event entitled “B -cell Lymphoma Franchise Update” on Tuesday, December 14, 2021 at 8:00 AM ET. The event will highlight interim Phase 1 clinical data from the Company’s FT516 and FT596 programs for the treatment of relapsed / refractory B-cell lymphomas. The live webcast of the presentation can be accessed under “Events & Presentations” in the Investors section of the Company’s website at www.fatetherapeutics.com.

  • On Nov 4, FATE reported business highlights and financial results for the third quarter ended September 30, 2021. Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics stated, “The interim Phase 1 data from our FT516 and FT596 programs in relapsed / refractory lymphoma demonstrate that our off-the-shelf, iPSC-derived NK cell product candidates have the potential to deliver substantial therapeutic benefit for patients along with a differentiated safety profile that supports outpatient treatment. We look forward to sharing additional clinical data from both of these programs at the American Society of Hematology Annual Meeting in December. We also continue to be pleased with the clinical advancement of our multiplexed-engineered, iPSC-derived NK cell pipeline, where we have now successfully treated the first patients with FT516 in disease-specific expansion cohorts for lymphoma and with FT538 in combination with daratumumab for multiple myeloma. Additionally, we have successfully completed GMP manufacture and release of FT576, our multi-antigen targeted, CAR BCMA product candidate for multiple myeloma, and have initiated enrollment in our Phase 1 study.”

• • On Oct. 1, Fate announced that one oral and four poster presentations for the Company’s induced pluripotent stem cell (iPSC) product platform were accepted for presentation at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) being held November 10-14, 2021. The oral presentation will highlight preclinical data for FT536, the Company’s off-the-shelf, multiplexed-engineered, iPSC-derived, chimeric antigen receptor (CAR) NK cell product candidate that uniquely targets the α3 domain of the MHC class I related proteins A (MICA) and B (MICB). In a recent publication in Cancer Immunology Research (DOI: 10.1158/2326-6066.CIR-19-0483), Kai W. Wucherpfennig, M.D., Ph.D., Chair of the Department of Cancer Immunology and Virology at the Dana-Farber Cancer Institute and co-leader of the Cancer Immunology Program at Dana-Farber / Harvard Cancer Center, demonstrated that cancers with loss of MHC Class I expression can be effectively targeted with MICA/B α3 domain-specific antibodies to restore NK cell-mediated immunity against solid tumors. The FT536 program is supported by an exclusive license from the Dana-Farber Cancer Institute to intellectual property covering novel antibody fragments binding MICA/B for iPSC-derived cellular therapeutics. The Company expects to submit an Investigational New Drug (IND) application for FT536 in the fourth quarter of 2021 for the treatment of advanced solid tumors, including in combination with monoclonal antibody therapy.

• • On September 15, Fate Therapeutics announced the publication of preclinical data demonstrating that its off-the-shelf, multiplexed-engineered, iPSC-derived NK cell product candidate FT538 exhibits significantly enhanced serial killing and functional persistence compared to peripheral blood NK cells. The superior anti-tumor activity of FT538 was attributable to its novel engineered components, including the knockout of CD38 and the expression of IL-15/IL-15R fusion protein, which were shown to improve metabolic fitness, increase resistance to oxidative stress, and induce transcription of proteins that control NK cell activation and effector function. The data were published in Cell Stem Cell in an online article entitled “Harnessing features of adaptive NK cells to generate iPSC-derived NK cells for enhanced immunotherapy”.

• 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 $2.01, +4.15% this week. 

• • 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.

• • On Nov. 30,  Atossa Therapeutics’ CEO, Dr. Steven Quay, M.D., Ph.D., and Kyle Guse, GC & CFO presented at our sister organization Tribe Public’s FREE Webinar Presentation and Q&A Event. During this complimentary event, Atossa management addressed Q&A from the Tribe focused on Atossa’s research programs and future development. You can watch the event video titled “A Town Hall Q&A Event With Atossa Therapeutics Management Team” at the Tribe Public YouTube Channel by clicking here. 

• • On Nov. 15, Atossa announced their financial results for the fiscal quarter ended September 30, 2021, and provided an update on recent company developments. Dr. Steven Quay, Atossa’s President and Chief Executive Officer stated, “Our progress in both the Endoxifen and COVID-19 programs, with our initiation of our trial in Australia for AT-H201, and our receipt of regulatory authorization in Sweden to commence an Endoxifen Phase 2 trial, have been key recent milestones, positioning us to move both of these programs forward and take the next steps toward developing therapies in 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,” Review the balance of the story here. 

• • On October 23, Dr. Steven Quay CEO of Atossa Therapeutics (NASDAQ: ATOS) published an interesting and informative video called “Long COVID Is An important Issue.” You may view by clicking here now.

• • On September 30, September 30, Atossa announced it has begun to enroll participants in its clinical study of AT-H201 in Australia. 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. “Even with vaccines becoming widely available, the COVID-19 pandemic continues to be an urgent global health crisis,” said Steven Quay, M.D., Ph.D., Atossa’s CEO and President. “Enrolling the first two participants in this study marks a significant milestone in our goal of ultimately developing nebulized AT-H201 to improve lung function in patients with active disease, which may reduce the number of patients requiring ventilators, and in ‘long-haul’ patients who have residual pulmonary function damage. Up to one third of hospitalized patients have pulmonary function changes 60 days or more after recovering from COVID. The portability of nebulizers, already routinely used for other chronic lung disease, should allow for treatment at home.”

• • On September 8th, Edward Woo, analyst at Ascendiant Capital Markets issued an update report titled “Q2 about inline. COVID-19 and breast cancer clinical trials expected to start soon should be catalysts for stock” and raided his P/T to $8.50.

• • On Aug 13th, Atossa announced financial results for the fiscal quarter ended June 30, 2021, and provided an update on recent company developments. “We continue to experience encouraging progress in our MBD and COVID-19 programs, with new regulatory approvals being granted in Sweden for a Phase 2 trial in MBD and authorization in Australia to commence a Phase 2 study of AT-H201 for respiratory illness associated with COVID-19. In the meantime, we continue to enjoy a strong balance sheet, which we have significantly expanded over the last three quarters and will facilitate our development plans over the near term. As we actively explore the possibility for strategic expansion into other areas where we might see near-term milestones and results, we also urge all of our shareholders to exercise their right to vote at our special stockholder’s meeting on September 7, 2021. We urge a vote in favor of the proposal to increase authorized shares, which will provide the Company with the flexibility to issue shares as part of these potential acquisitions, collaborations and partnerships, a common strategy successful biotech companies seeking to grow shareholder value employ in order to create a more attractive opportunity for all. We look forward to continuing to update our stockholders on these opportunities as they develop,” stated Dr. Steven Quay, Atossa’s President and Chief Executive Officer.

• 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 $3.37, +14.24% this week.   

• • On Dec. 1, INVO Bioscience announced the Company has received approval by Medical Devices Control Division for FDA Thailand to import and commercialize INVOcell in Thailand. In April 2021, INVO Bioscience entered an exclusive distribution agreement with IVF Envimed Company Ltd. to distribute the INVOcell system within Thailand. Established in 1993, IVF Envimed Company Ltd. has established a wide network of clinics and hospitals across Thailand primarily focused on fertility solutions. IVF Envimed is a member of the ‘Thai Society of Reproductive Medicine’ which organizes congresses and educational programs where IVF Envimed participates. In November 2021, INVO Bioscience started to train physicians and embryologists from both private and government hospitals. In early 2022, INVO Bioscience and IVF Envimed will organize several ‘in person’ trainings in Bangkok with key fertility experts to supplement currently ongoing online trainings. INVO Bioscience is also planning to conduct a locally-based evaluation study to have localized data, a key element for both physicians and patients. “Following months of efforts and interactions with the governmental authorities in Thailand, we are thrilled to have received approval by FDA Thailand to commence commercialization of the INVOcell solution within Thailand,” commented, Steve Shum, CEO of INVO Bioscience. “Over the past number of months, we have been working closely with our partners at IVF Envimed to educate key opinion leaders within the country, including the recent training of several physicians and embryologists that should allow us to begin scaling up our commercialization efforts within the country. Further, we have identified physicians to help us with localized data collection on initial patients to assist in our longer term marketing efforts within the country. We look forward to working with Envimed and supporting their efforts to deliver the INVOcell solution in Thailand help address the underserved patient market in need of advanced reproductive treatment.”

• • On Nov 16, Colliers Secuirites issued an update report titled “Dedicated INVOcell Clinics To Begin Meaningful Sales in CY22. Decision On 5-Day label Expansion Expected in 1Q22.” The report carried a BUY rating on INVO and a Price Target of $6.

• • On Nov. 15, INVO announced their financial and operating results for the third quarter ended September 30, 2021, and provided a business update. Steve Shum CEO of INVO stated , “We continue to execute against our core mission of improving access to advanced fertility services for the many patients around the world through the use of the INVOcell solution. During the quarter, we achieved a significant milestone with the opening of our very first INVO Center, based in Birmingham, where we have commenced initial cycles. Further, we opened clinics in Atlanta, Georgia and Monterrey, Mexico to expand the INVO Center business model and we are working to open the San Francisco Bay Area clinic as soon as possible. We completed the acquisition of a Canadian-based entity that will be used to distribute the INVOcell in Canada and to develop INVO Centers in the region. With our INVO Center strategy now successfully underway, we are optimistic on the prospects for further expansion using this unique and innovative model. As part of a detailed review, we have initially identified more than 20 cities here in the U.S. that we believe have excellent characteristics in terms of demographics and level of current fertility care that would be ideal locations for an INVO Center.” READ the balance of the story here. 

• • On Nov. 8 after the market closed, INVO announced that it will regain full U.S. commercialization rights for its patented INVOcell® device due to Ferring International Center S.A.’s termination for convenience of that certain Distribution Agreement dated November 12, 2018 with INVO, which termination will officially take effect on January 31, 2022. Over the past three years, INVO has been executing on a multi-faceted commercialization strategy which includes partnering to open dedicated “INVO Centers” focused on INVOcell and the IVC procedure, and establishing agreements with distributors in key markets. The terms of the U.S. Distribution Agreement had limited the number of INVO Centers that we were allowed to operate. INVO can now further support U.S. fertility clinicians directly as the exclusive provider of INVOcell® in pursuit of our mission to bring advanced fertility care to the millions of people that are without access to treatment.

• • On October 20, INVO Bioscience, Inc. announced that four exciting poster abstracts were presented discussing INVOcell at the 77th Scientific Congress & Expo of the American Society for Reproductive Medicine (ASRM) being held this week in Baltimore, Maryland. “It’s extremely rewarding to see our technology highlighted at this year’s ASRM. Four independent abstracts were selected for presentation at the fertility industry’s most prominent annual meeting. On behalf of the entire INVO team, we sincerely appreciate the work of the many clinicians that now support INVOcell as a solution and thank those that contributed their independent work in advancing the understanding of the unique capabilities of INVOcell. These types of events and studies emphasize the opportunity we have to democratize advanced fertility services through the unique attributes of the INVOcell solution and bring care to the large, underserved patient population around the world,” stated Steve Shum, CEO of INVO Bioscience. LEARN MORE! 

• • On Oct. 14, INVO announced that November 1, 2021 will be the grand opening date for the Company’s INVO Center joint venture, based in Monterrey, Mexico. The new center, named “Positib Fertility, an INVO Center,” will focus on patients in need of advanced fertility care utilizing the efficient, effective, and affordable INVOcell solution.

• • On Oct. 1, INVO announced that it has entered into definitive agreements with institutional and accredited investors and members of INVO Bioscience’s management team to purchase 1,240,763 shares of its common stock at a purchase price of $3.26 per share, in a registered direct offering priced at-the-market under Nasdaq rules, for gross proceeds of approximately $4.0 million. The registered direct offering is expected to close on or about October 5, 2021, subject to the satisfaction of customary closing conditions.

• • • The group of investors includes members of INVO Bioscience’s management team, including Steve Shum, CEO, and Andrea Goren, CFO. Paulson Investment Company, LLC is acting as the exclusive placement agent for the offering. The gross proceeds from the offering are expected to be approximately $4.0 million, before deducting placement agent’s fees and other offering expenses. INVO Bioscience currently intends to use the net proceeds from this registered direct offering for general corporate and working capital purposes.

• • • Also, on Oct. 1, INVO entered into a separate Stock Purchase Agreement with Paradigm Opportunities Fund, LP an accredited institutional investor, pursuant to which we will issue to such investor 600,703 shares of their common stock, par value $0.0001 per share for a purchase price of $3.329 per share for an aggregate purchase price of $1,999,740.29. This transaction is set to close on November 30, 2021. The Shares will be issued under the exemption from registration under Section 4(a)(2) and/or Rule 506 of the Securities Act of 1933, as amended. The Purchase Agreement contains a $250,000 break-up fee whereby if either party fails to close, it will be required to pay the non-breaching party a fee of $250,000. The investor under the Purchase Agreement also agreed to a 1-year lock up period with respect to the Shares.

• • On September 9th, INVO Bioscience announced that it has completed the acquisition of a Canadian-based entity that was originally formed to offer INVOcell in Canada. The entity had previously completed a number of important procedures and documentation necessary to establish INVOcell within clinical operations in Canada. INVO Bioscience anticipates leveraging this entity to advance the distribution of INVOcell, and take advantage of the existing product registration which approved the device for sale based on 5-day incubation in the Canadian market. In addition, the Company is initiating the development of joint ventures to establish INVO Centers within the Canadian marketplace, similar to U.S. and Mexico markets, to further drive accelerated adoption of the INVOcell solution while also increasing much needed capacity and patient access within the fertility industry. Steve Shum, CEO of INVO Bioscience, commented, “We believe Canada offers an excellent opportunity to further expand our distribution efforts of INVOcell while also advancing our joint-venture based INVO Center model. With roughly 16% (or 1 in 6) couples in Canada experiencing infertility, a number that has doubled since the 1980s, and with a popultion of 37.74 million, Canada represents a sizable market opportunity. Canada also faces similar issues that hamper other parts of the world, including a large underserved population, access/capacity constraints and affordability challenges. We appreciate the key individuals in Canada that originally created this entity to help promote and bring our INVOcell technology into the marketplace and look forward to bringing greater resources to advance this effort. We anticipate this acquisition will serve as a platform to help accelerate building INVOcell’s presence in Canada.”

  • On September 7th,  INVO Bioscience announced that it has officially opened the Company’s 2nd INVO Center in the United States, based in Atlanta, Georgia after recently opening their first in Birmingham, AL called “Innovative Fertility Specialists, An INVO Center” on August 9th. INVO Centers are further scheduled this year to open in Monterrey, Mexico & the San Francisco Bay Area. This new joint-venture, named “Bloom Fertility, an INVO Center,” will focus on patients in need of advanced fertility care utilizing the efficient, effective, and affordable INVOcell solution. READ THE COMPLETE STORY. 

  • On August 16th, INVO announced their financial and operating results for the second quarter ended June 30, 2021 and provided a business update. Steve Shum , CEO of INVO stated. “Our team made excellent progress during the second quarter of 2021 toward our key objectives, headlined by last week’s official opening of our first INVO Center practice in Birmingham, AlabamaWe feel INVO is now well positioned for success based on the following core foundational elements developed over the past 2 years. We believe there is a substantial underserved patient population with infertility challenges and a real need to expand access to treatment. In our opinion, this is a multi-billion-dollar market expansion opportunity, and INVOcell is well positioned to address the unmet medical need.”

• • On Aug.2, INVO announced the Company’s first Joint Venture INVO Center practice in the United States, based in Birmingham, Alabama, will officially open on August 9, 2021. Dr. Hammond commented, “With the opening of the country’s first INVOcell medical practice, we are advancing a core mission towards improving access to advanced fertility services for the many patients who would otherwise never have the opportunity. To date, we have already received numerous advanced inquiries via word of mouth and have dozens of patients scheduled for initial patient consultations who are eager to proceed with treatment. As we officially open the center next week, we expect to accelerate our marketing programs with the help of the INVO marketing team to enhance overall patient awareness around Innovative Fertility Specialists, An INVO Center.”

• • On July 14th, INVO announced the appointment of world renowned women’s health expert, Dr. Barbara Levy, M.D., FACOG, FACS as the Company’s Senior VP, Global Clinical Integration to accelerate affordable infertility treatment INVOcell’s Global OB/GYN Clinical Integration Strategy. Dr. Levy is considered one of the most influential clinical executives in the world, recently serving as Vice President, Health Policy at the American College of Obstetricians and Gynecologists (ACOG) and chair of the American Medical Association/Specialty Society Relative Value Scale Update Committee. She joins INVO Bioscience to help further develop and accelerate the Company’s global OB/GYN channel strategy. Steve Shum, CEO of INVO Bioscience, said, “We are excited to have Dr. Levy join the INVO team to support our mission to bring care to the vast underserved patient population around the world experiencing infertility challenges. She has a clear understanding of the role that OB/GYNs can play in helping to democratize fertility care on a global basis by providing accessibility to affordable and effective treatments, the key hallmarks of the INVOcell technology. We look forward to leveraging her experience, relationships, and influence to accelerate our OB/GYN clinical implementation strategy in the years to come.”

• • On June 30th, VP Watchlist company, INVO Bioscience, Inc. (NASDAQ: INVO) expanded their North American footprint as they announced on June 30th that they had signed a joint venture agreement in partnership with reproductive specialist Dr. Sue Ellen Carpenter, M.D. through its wholly-owned subsidiary, INVO Centers, LLC, to open an INVO clinic in Atlanta. The clinic, Bloom Fertility, is scheduled to open in the second half of 2021. INVO Bioscience will provide funding for start-up and operating costs and own 40% of the Atlanta Joint Venture. Dr. Sue Ellen Carpenter, MD, is Board Certified in Obstetrics and Gynecology. With over 30 years of experience in reproductive medicine, Dr. Carpenter’s specialties include in vitro fertilization, treating congenital anomalies associated with infertility, as well as endometriosis and polycystic ovarian syndrome. Noted for excellence in her field and a “Top Doctor, Atlanta 2019 and 2020″ she delivers lectures across the country and has published more than a dozen papers on reproduction and fertility. She is an active member of the American Society of Reproductive Medicine (ASRM) as well as the Georgia OB GYN Society. Note that INVO Bioscience has also signed clinic partnerships in Birmingham, Alabama and the San Francisco Bay area earlier this year, along with its Mexico partnership in late 2020, which is scheduled to open later this year. These clinics, through the utilization of the INVOcell technology, in addition to the multiple clinic and distribution partnerships throughout the world are bringing advanced fertility care and much needed expanded access to the millions of underserved people.

• • On June 15th, INVO Bioscience, Inc. (NASDAQ: INVO), announced further foundational progress as they appointed of Andrea Goren as the Company’s Chief Financial Officer. In a career approaching 27 years, Mr. Goren has extensive experience in numerous financial functions, including service as a public company CFO, company director, capital raising activities as well as mergers and acquisition experience. Mr. Goren has served as managing director and CFO of Phoenix Group, a New York City-based private equity firm specializing in micro-cap and nano-cap public companies. He served as vice president of Shamrock Group, the Roy Disney family private investment firm in London; and was a director at New York City-based Madison Capital Group, a corporate advisory firm focused on U.S. / European Union cross border transactions. Mr. Goren holds a Bachelor of Arts degree from Connecticut College in New London, Connecticut, and an MBA from the Columbia Business School in New York City.

• • On May 11, a 13G was filed that confirms that David Sable’s (a former #IVF doc turned portfolio manager) Special Situations Fund of AWM Investment Company increased their ownership to 11.1% or 1,154,153 share ownership of INVO Bioscience (INVO). They held 625k/6.5% as of the 13G filing 2-12-2021. If you are not familiar with them, I believe if you do a relatively small amount sleuthing you will find out that they are one of the most successful multi-billion funds over the last 20-years, especially in finding small undiscovered microchips. I believe that they led the round of $13M at $3.20 a share in November 12, 2020 that pushed INVO uplist to the NASDAQ. Here’s the 13G filing. The company only has 10,424,229 shares issued and outstanding as of March 31, 2021.

• • Industry forecasts suggest that only 1% to 2% of the estimated 150 million infertile couples worldwide are currently being treated. INVO’s mission is to increase access to care and expand infertility treatment across the globe with a goal of improving patient affordability and industry capacity. Since January 2019, INVO Bioscience has signed commercialization agreements in the United States, India, as well as parts of Africa and Eurasia and Mexico for the INVOcell device.

• Shares NeuBase Therapeutics (NBSE)  a biotechnology platform company Drugging the Genome™ to address disease at the base level using a new class of precision genetic medicines, closed at $2.91, +8.18% this week.