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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 $8.88, +1.14% over the last 5-days. The 52-wk range is $8.18 – $30.37.

• • On Jan. 25, INmune announced that the company has entered into a pre-clinical research collaboration with Chinese University of Hong Kong (CUHK) to evaluate INKmune™ — the company’s pseudokine NK cell priming platform — in nasopharyngeal cancer (NPC), a type of head and neck cancer. The Strategic Partnership Award for Research Collaboration, which was granted by the CUHK Office of Academic Links, is between Prof. Michael Tong at CUHK and Prof. Mark Lowdell at University College London (UCL) and Chief Scientific Officer of INMB. The project provides INMB scientists working at UCL with access to the only three proven NPC cancer cell lines to test the ability of INKmune-primed NK cells to kill NPC tumors.
     
    Prof. Lowdell stated, “Our colleagues at CUHK have been studying NK cell responses to NPC for many years but have not yet translated them into clinical trials. They have shown the need for cytokine activation with IL2 or IL15 to achieve tumor killing. We believe pseudokine activation by INKmune will provide all the relevant NK activating signals of IL2 and IL15 plus a host of other critical NK survival signals and generate memory-like NK cells. We are confident that these INKmune primed cells will kill NPC tumor cells very effectively and we look forward to a mutually beneficial collaboration.”
     
    RJ Tesi, INmune Bio’s Chief Executive Officer stated, “Over 180,000 cases of NPC were diagnosed last year with 85% originating in Asia. Current treatments are quite poor, leading to high mortality rates. History of EBV infection (commonly known as mono) and genetic polymorphisms drive the incidence of the disease. This peer-reviewed grant and international collaboration targeting what has historically been a difficult to treat solid tumor validates the versatility of INKmune. We look forward to translating this work to the clinic in the near future.”

• • 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.”

• • The Maxim Group’s analyst Jason McCarthy confirmed his $42 Price target in 2H/2021.  

• 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 $1.07, -13.01% over the last 5-days. Please visit the INM page at our website to learn more and check out the videos section too. The 52-wk range is $1.20 – $8.94. 

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

• • On Jan. 6, our sister organization, Tribe Public, held a FREE Webinar Presentation and Q&A Event with InMed Pharmaceuticals (NASDAQ: INM) titled “Addressing The Increasing Demand For Rare Cannabinoids” with Eric A. Adams, MIBS, CEO & President of InMed Pharmaceuticals (NASDAQ: INM) SVP, General Manager of BayMedica Shane Johnson, MD & VP, Commercial Operations Chris Meiering, PhD. The event was very interesting and informative, well attended, and now the event video is now published at the Tribe Public YouTube Channel. You may view it now by clicking here. 

• • 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 Dec. 20, InMed announced that a peer-reviewed scientific article entitled “Cannabinol Modulates Neuroprotection and Intraocular Pressure: A Potential Multi-Target Therapeutic Intervention for Glaucoma”, has been published in Biochimica et Biophysical Acta (BBA – Molecular Basis of Disease), a leading international journal focused on biochemistry and molecular genetics of disease processes and models of human disease in the area of aging, cancer, metabolic-, neurological-, and immunological-based diseases. The peer-reviewed article highlights research evaluating the use of cannabinol, or CBN, as a potential treatment option for glaucoma. Several studies were conducted to evaluate the survival of retinal ganglion cells, modulation of intraocular pressure and its effects on extracellular matrix proteins using in vitro and in vivo glaucoma models. These studies resulted in two key findings: first, CBN may promote neuroprotection of cells in the retina that are responsible for vision; and second, CBN may normalize intraocular pressure by attenuating changes in the extracellular matrix proteins. The article also reports on the comparison of CBN with other cannabinoids, including cannabidiol (CBD) and tetrahydrocannabinol (THC), with results indicating that CBN has a stronger effect and broader neuroprotective therapeutic range. These observations elucidate the therapeutic potential for CBN in the treatment of glaucoma.

• • 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 $36.63, -1.4% over the last 5-days. 

• • 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.”

  • 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 $1.24, -1.59% over the last 5-days. 

• • 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.

• • 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. 

• 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 $2.81.

• • On Dec, 16, INVO Bioscience, Inc. announced that it has entered into an expanded agreement with Ovoclinic, a group of clinics specialized in assisted reproductive treatments with four locations across Spain (Madrid, Marbella, Málaga, Ceuta) and collaborating centers around Europe, to accelerate adoption of INVOcell within their markets. The agreement includes the expanded adoption of INVOcell within Ovoclinic locations as well as establishing an INVO Center of Excellence for future training for the European Market. Cristina Gonzalez, embryologist and Quality Manager of Ovoclinic laboratories stated, “After several successful trials implementing the exciting INVOcell fertility treatment, Ovoclinic aims to provide its patients with this effective alternative to the processes used so far in Spain in the field of reproductive medicine. We consider INVOcell to be an effective method of natural reproduction that involves the future mother at the very first moment of the process. We are confident that this innovative treatment will help many patients to choose this new alternative solution to achieve their dream of forming a family by actively participating in the reproductive process.” According to the World Bank, Spain, with total population of approximately 47 million people, has one of the lowest fertility rates in Europe, affecting approximately 15% of the population, or one in seven couples of reproductive ages. According to reports, in 2010, there were approximately one million couples requesting assisted reproductive treatment, however only 22% received one or more assisted reproductive treatment cycles. The average waiting time for an IUI or IVF cycle in a public health facility was 339 days. Ovoclinic reports that they maintain the best technical and human resources to deal with all kinds of infertility problems along with the simplest and most natural treatments to the most complex and advanced techniques pioneered in Spain. Ovoclinic also works in partnership with Ovobank, the first European Donor Egg Bank in Europe.

• • 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 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 $1.37, -11.61%.

• • On Jan. 10, NeuBase announced  the appointment of Todd P. Branning as Chief Financial Officer (CFO). Mr. Branning has more than 25 years of experience leading corporate finance and accounting, tax, financial planning and analysis, and investor relations for several publicly traded pharmaceutical companies. Prior to joining NeuBase, Mr. Branning was CFO of Phathom Pharmaceuticals, Inc., a publicly traded late clinical-stage biopharmaceutical company. Before that, he was Senior Vice President, CFO of Amneal Pharmaceuticals, Inc., a publicly traded pharmaceutical company, where he helped to build, leverage, and optimize infrastructure following the completion of a transformational merger. Prior to joining Amneal, he was Senior Vice President, CFO of the global generic medicines division at Teva Pharmaceutical Industries Ltd., a multinational generic pharmaceuticals company, where he led the finance function and served on the leadership team responsible for managing the day-to-day operations of Teva’s largest multi-billion-dollar commercial unit. Mr. Branning has also held financial leadership roles at Allergan plc, PricewaterhouseCoopers LLP, PPG Industries, Inc., and Merck & Co., Inc. Mr. Branning received his BBA from the University of Miami and MBA from Carnegie Mellon University. Mr. Branning is also a Certified Public Accountant and has completed a CFO certification program at The Wharton School at the University of Pennsylvania.

• • On Jan. 5, Neubase announced the appointment of Eric J. Ende, M.D., to the Company’s Board of Directors. Dr. Ende has nearly 25 years of experience in advising biotechnology and life sciences companies to optimize corporate strategy and structure and maximize shareholder value. “Dr. Ende has the experience and perspective to recognize the opportunity ahead for NeuBase as it plans for the clinical development of its potentially transformational new class of precision genetic medicines,” said Dietrich A. Stephan, Ph.D., Founder, CEO and Chairman of NeuBase. “We welcome Dr. Ende’s strategic insight as we begin to scale our therapeutic candidate pipeline from our new precision genetic medicines platform technology. In addition to his broad experience, he also shares in our Company’s goal of helping millions of patients with both common and rare conditions that currently have limited or no treatment options.” “I believe NeuBase has a game-changing technology that overcomes the limitations of early precision genetic medicines by delivering mutation selectivity, repeat dosing, and systemic administration in a modular precision medicine platform with the potential to efficiently scale to treat a wide variety of diseases that are currently undruggable,” said Dr. Ende. “I look forward to working closely with NeuBase’s leadership team and Board of Directors to elevate strategy and operations in order to create exceptional value for patients and shareholders.” Dr. Ende currently is the President of Ende BioMedical Consulting Group. He also is a member of the Board of Directors of Matinas BioPharma, where he is the Chairman of the Compensation Committee and serves on the Audit and the Nomination & Governance Committees, and of Avadel plc, where he is the Chairman of the Nomination & Corporate Governance Committee and serves on the Audit and Compensation Committees. Dr. Ende previously served on the Board of Directors of Progenics (acquired by Lantheus Holdings) and Genzyme (acquired by Sanofi-Aventis for $20 billion). During his time on Genzyme’s Board of Directors, Dr. Ende was a member of the Audit and Risk Management Committees. Prior to Genzyme, Dr. Ende was a biotechnology analyst, previously serving at Merrill Lynch, BofA Securities, and Lehman Brothers. Dr. Ende received an M.B.A. from NYU Stern School of Business, an M.D. from the Icahn School of Medicine at Mount Sinai, and a B.S. in biology and psychology from Emory University.

• • On Dec. 23, NeuBase reported its financial results for the fiscal year ended September 30, 2021, and other recent developments. As of September 30, 2021, the Company had cash and cash equivalents of approximately $52.9 million, compared with approximately $32.0 million as of September 30, 2020. NeuBase estimates its current cash and cash equivalents are sufficient to fund currently planned operating and capital expenditures into the first quarter of CY2023.

• • • “NeuBase is focused on significantly reducing the burden of untreatable morbidity and mortality caused by rare and common diseases across the globe. To achieve this goal, we designed, built, and validated a new precision genetic medicines platform technology that can uniquely drug the double-stranded human genome and address disease at the root of causality without many of the limitations of early precision genetic medicine technologies. We are poised to file our first Investigational New Drug (‘IND’) applications with the U.S. Food and Drug Administration (‘FDA’) beginning in calendar year 2022 and intend to scale into additional indications with increasing speed and efficiency thereafter,” said Dietrich A. Stephan, Ph.D., Founder, Chief Executive Officer, and Chairman of NeuBase.

• • • “This past year, we validated the ability of our technology in proof-of-concept studies to directly drug the double-helix of the human genome, including difficult double-stranded structures of RNA targets, and engage with mutant genes to resolve most causal mechanisms of disease. The validation of our platform’s capabilities included data describing that we have overcome many limitations of early precision genetic medicine technologies, such as biodistribution, tolerability, selectivity, manufacturability, durability, and scalability. We also presented data that our delivery shuttle enables compounds to elicit pharmacologic effects in multiple tissues, including in the brain and muscle, after subcutaneous administration in preclinical animal models,” said William Mann, Ph.D., M.B.A., Chief Operating Officer of NeuBase.

• • • “We recently nominated the development candidate for our myotonic dystrophy type 1 (DM1) program, which we believe has the potential to be a best-in-class therapy that offers a patient-friendly route of administration, a whole-body solution for the muscle, heart, and brain manifestations of the disease. Furthermore, the mechanism of action of our development candidate is designed to engage with the toxic RNA hairpin structure to release the splicing proteins, restoring normal RNA splicing and downstream protein production, including DMPK. We have initiated IND-enabling studies for this candidate, with data read-outs expected across CY2022. We expect these data will support the submission of an IND filing to the FDA in the fourth quarter of CY2022,” stated Sandra Rojas-Caro, M.D., Chief Medical Officer of NeuBase.

• • • “As a result of the nomination of our DM1 program candidate, we established CMC expertise at our new facility in Cambridge, Massachusetts that is co-located with our clinical development team, finalized the formulation of our development candidate to enable systemic routes, and completed process development. We also scaled-up manufacturing in-house and with contract manufacturing partners to support non-clinical toxicology, product stability, and Phase 1/2 clinical trials,” said Tony Rossomando, Ph.D., Chief Technology Officer of NeuBase.

• • • Dr. Stephan concluded, “In parallel, we are making significant progress in our therapeutic program for Huntington’s disease. For example, we have illustrated with preclinical in vivo data that our proprietary delivery technology allows our genome-targeting compounds to advance beyond intrathecal delivery and enabling a systemically administered allele-selective therapy, overcoming challenges seen with other programs. Furthermore, preclinical data show that our PATrOL™-enabled compounds can silence activating KRAS point mutations in vivo to inhibit protein production, which has the potential to target G12D and G12V, the two most common and historically ‘undruggable’ cancer-driving point mutations that represent the majority of KRAS tumors. We believe these data set the stage for a potentially first-in-class precision genetic medicine approach for oncology capable of selectively targeting mutations at the single-base level.”