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• Shares of INmune Bio, Inc. (NASDAQ: INMB), a clinical-stage immunology company focused on developing treatments that harness a patient’s innate immune system to fight disease, closed at $7.42 The 52-wk range is $6.40 – $30.37.

• • On March 3, INmune Bio reported its financial results for the year ended December 31, 2021 and provided a business update. INmune Bio highlighted that in December, the Company reported data from the first patient treated with INKmuneTM in the myelodysplastic syndrome (MDS) Phase I clinical trial. More than 100 days after the course of INKmuneTM therapy, 60% of the patient’s NK cells showed the activated, tumor killing memory like NK cells phenotype, a fourfold increase from pre-treatment. The patient’s memory like NK cells killed >70% of NK resistant tumor cells in an in vitro assay. The patient remains well and with an ECOG status of 0, a two-point drop from pre-treatment. Additionally, two patients were treated with INKmuneTM under compassionate use after having failed at least one allogeneic bone marrow transplant. One of the two patients has been discharged home, one remains hospitalized. In all cases, INKmuneTM therapy was well tolerated, safe and was given without any type of pre-medication or cytokine therapy.

• • 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. 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.”

• 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 $.7449.  Please visit the INM page at our website to learn more and check out the videos section too. The 52-wk range is $.68 – $4.92. 

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

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

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

• • On Jan. 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 $33.55, +3.33% over the last 5-days. 

• • On Feb. 28, Fate Therapeutics reported business highlights and financial results for the fourth quarter and full year ended December 31, 2021. Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics, “We have begun 2022 with strong clinical and regulatory momentum driving our off-the-shelf, iPSC-derived NK cell programs in relapsed / refractory lymphoma, and look forward to working with the FDA under the Regenerative Medicine Advanced Therapy designation to accelerate therapeutic development in areas of significant unmet need, such as patients who have progressed following autologous CAR T-cell therapy, and to bringing transformative cell therapies to patients in the community setting including as part of early-line treatment. We maintain a strong financial position and are poised in 2022 to achieve key clinical milestones and data read-outs across our wholly-owned disease franchises, to extend our leadership in the manufacture and CMC of iPSC-derived cell therapies with the launch of our second cGMP manufacturing facility, and to bring new multiplexed-engineered NK and T-cell product candidates to patients.”

• • 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 $1.21, 0.00% over the last 5-days. 

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

• • On Feb. 28, Atossa announced their financial results for the fiscal quarter and fiscal year ended December 31, 2021 and provides an update on recent company developments. Dr. Steven Quay, Atossa’s President and Chief Executive Officer stated, “We continue to make significant progress on our Endoxifen and COVID-19 programs, with the continuation of enrollment of the Australian trial for AT-H201, as well as enrollment in our Swedish Endoxifen Phase 2 trial. We look forward to moving into the next milestones during 2022, and to providing updates on these developing therapies for urgent unmet patient needs. Further, our strong balance sheet will continue to facilitate our development plans as we not only execute on these trials but also explore additional options that could create significant shareholder value.” READ The Balance of the story. 

• • On Jan. 27, Atossa issued the annual letter from President and CEO Dr. Steven C. Quay to Atossa stockholders.  The letter Bega as follows: “The last two years have changed the face of public health and uncovered the urgency to develop products not only to prevent widely spread infectious diseases, but to treat them with the same level of focus and dedication applied to prevention. Despite the launch of highly efficacious vaccines during 2021, the toll that COVID-19 was taking on public health was not reduced. The rise of the Omicron variant toward the end of the year, and emerging long-term impact of long COVID, remain an important public health priority, and one that Atossa is dedicated to addressing. A key feature of the original SARS-CoV-2 virus, and that is retained in both the Delta and Omicron variants, is the furin cleavage site found on the Spike protein which facilitates viral infection. Our COVID-19 programs under development are designed to interact with this cleavage site so they are expected to be effective against both current and future COVID-19 variants that continue to contain a furin cleavage site. In the meantime, we are also very excited about the ongoing development of our breast health programs with our proprietary drug Endoxifen, with one Phase 2 study underway and another expected to commence in the next quarter. We raised over $110 million in capital in 2021 and we are well positioned to execute on our programs in 2022.” Click here to read the balance of the letter now.

• • On Jan. 18, Atossa announced it is advancing to enroll participants in Part B of its Phase 1/2a clinical study of AT-H201 in Australia, consisting of multiple ascending dose cohorts in healthy participants. The nebulized formulation, AT-H201, is being developed as an inhalation therapy for moderately to severely-ill hospitalized COVID-19 patients and for “long-haul” patients with post-infection pulmonary disease. Part A of the study, which consisted of a single ascending dose group of 4 cohorts of healthy participants, has now been completed. The Australian Human Research Ethics Committee has reviewed the safety data from Part A and has approved the study to proceed to Part B. “The results of the first part of the study were extremely encouraging and the ethics committee concluded we may now proceed to enroll the next group of participants,” said Steven Quay, M.D., Ph.D., Atossa’s CEO and President. “A record number of hospitalizations driven by the Omicron variant is producing a crisis at many healthcare facilities. Additional therapies to combat COVID-19 are desperately needed.” The Phase 1/2a placebo-controlled study will enroll a total of 60 healthy participants and moderately-ill hospitalized COVID-19 patients. The study has 4 parts: Part A – a single ascending dose part, Part B – a multiple ascending dose part, Part C – a combination part in healthy individuals, and Part D a combination in COVID-19 infected patients. The study is being conducted by Avance Clinical Pty Ltd., a leading Australian clinical research organization. AT-H201 is a proprietary combination of two drugs previously approved by the FDA to treat other diseases and by other administration routes. AT-H201 is intended to be inhaled via a nebulizer to improve compromised lung function for moderate to severely ill, hospitalized COVID-19 patients and for “long-haul” patients with post-infection pulmonary disease. In May 2020, we completed in vitro testing of AT-H201 which showed that the components of AT-H201 inhibit SARS-CoV-2 infectivity of VERO cells, which is a standard cell type being used to study infectivity of the coronavirus. The Phase 1/2a study in Australia and other clinical studies must be successfully completed and regulatory approvals must be obtained before AT-H201 may be commercialized. No assurance can be given than studies will be successful or that regulatory approvals will be obtained.

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

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

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

• • 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 $2.33.

• • On Feb. 16, INVO announced plans to open its next INVO Center in Tampa, Florida. The Tampa INVO Center will focus on patients in need of advanced fertility care utilizing the efficient, effective, and affordable INVOcell® solution. The company currently has three operational INVO Centers treating patients in Birmingham, Alabama, Atlanta, Georgia, and Monterrey, Mexico, with another scheduled to open in the San Francisco area. “Following significant diligence and in consultation with industry experts, we are excited to announce Tampa as the next INVO Center location,” commented Steve Shum, CEO of INVO. “The characteristics and demographics of the Tampa market lend themselves perfectly to our INVO Center approach focused on expanding access to advanced fertility services for the significantly underserved patient population. By leveraging the blueprint and experiences from our earlier centers, we look forward to opening the clinic in 2022 and advancing our mission of democratizing fertility care. We are also actively conducting due diligence in several other markets as we look to initiate further expansion of our INVO Center commercialization platform.” The company expects to engage physician partners, similar to the models deployed in its other centers.

• • On Feb. 3, INVO announced that effective February 1, 2022, INVO has regained full U.S. commercialization rights to its INVOcell technology, enabling the Company to sell directly into existing IVF clinics, to expand the number of INVO Centers free of any limitations, and to pursue its market expansion strategy focused on increasing access to care and democratizing fertility care for underserved patients. Today, the global fertility market is a multi-billion industry, yet remains severely underserved, with estimates suggesting more than 90% of couples in need of infertility treatment going without care. INVO believes INVOcell and the IVC procedure are well suited to address existing industry capacity challenges and provide an affordable and effective fertility option for patients in need. Mike Campbell, COO and V.P. Business Development of INVO stated, “We are now able to synchronize and take an expanded, more comprehensive and direct approach toward our U.S. commercialization efforts. In addition to supporting and expanding upon the approximate 100 U.S. IVF clinics that have trained on the INVOcell device and the IVC treatment process for their operation, we expect to advance our INVO Center efforts as a critical part of the U.S. strategy moving forward. With our initial three centers now fully operational and focused on delivering INVOcell and the IVC procedure, we are excited to continue rolling out additional centers. As previously noted, we have initially identified over 20 cities in the U.S. as attractive markets. We believe our multi-channel commercial strategy of supporting, servicing, and expanding across the existing IVF clinic network as well as building new, dedicated INVO Centers will help drive increased market awareness of our revolutionary technology, and provide a viable option to help served the large, underserved patient population.”

• • 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 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 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.

• • 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 $1.50, -3.23% over the last 5-days. 

• On Feb. 28,  Neubase announced that new preclinical data from its myotonic dystrophy type 1 (DM1) program will be featured in presentations at the 2022 MDA Clinical & Scientific Conference. MDA 2022 will be taking place virtually and in-person in Nashville, Tennessee, from March 13-16, 2022, and the abstracts will be available on the meeting website. Expanding upon initial data presented in June 2021, the presentations will include new data of a PATrOL™-enabled investigational genetic therapy for DM1. NeuBase will present molecular and functional pharmacological activity of its DM1 investigational genetic therapy in the HSALR mouse model following single and repeated subcutaneous, intravenous, and intramuscular administration. The HSALR model carry the long repeat (LR) length of the DMPK repeat expansion and recapitulates many aspects of the clinical presentation of DM1. Additional pharmacokinetic data will be presented of NeuBase’s DM1 investigational genetic therapy in wild-type mice demonstrating distribution and pharmacologic activity throughout the body, including the brain and muscle, following systemic administration. Patients with DM1 suffer from cognitive deficits and muscle pathology caused by a trinucleotide expansion in the DMPK gene. NeuBase’s DM1 investigational genetic therapy targets DMPK pre-mRNA with a novel peptide-nucleic acid (PNA) pharmacophore and is designed to selectively engage with the toxic RNA hairpin structure and release the splicing proteins to restore RNA splicing and downstream protein production. The PNA pharmacophore is conjugated to NeuBase’s novel delivery technology that is designed for broad distribution, including into the deep brain, with the potential for a whole body, disease-modifying solution for DM1.

• On Feb. 10, NeuBase reported its financial results for the three-month period ended December 31, 2021, and other recent developments. Dietrich A. Stephan, Ph.D., Founder, Chief Executive Officer, and Chairman of NeuBase stated,  “We are making significant progress in advancing the IND-enabling studies for the development candidate for our myotonic dystrophy type 1 (DM1) program, and we expect to file an IND with the FDA in Q4 CY2022. These studies are on track for data readouts to occur throughout CY2022, with the first presentation of rodent pharmacokinetic and bioavailability data to occur at an upcoming scientific meeting. We expect these data to illustrate the differentiated potential for our candidate to be a whole-body solution to treat DM1 and the unique ability of our delivery shuttle for distribution into the brain. The ability to cross the blood brain barrier and reach the deep brain is also especially relevant for our Huntington’s disease program, where we are planning to initiate scale-up and toxicology activities this year. In addition, I’m especially excited to have welcomed Todd to the executive team as Chief Financial Officer. The team and science are strong, and I believe we are at a pivotal moment for NeuBase as we are building a robust data package that is expected to support bringing our first candidate into the clinic for DM1, validate our genetic medicine technology platform to efficiently deliver genetic medicines with broad tissue distribution, including into the deep brain, and to precisely engage genetic mutations in a manner that is well-tolerated with the potential for sustained efficacy.” READ THE BALANCE OF THE RELEASE HERE. 

Dietrich A. Stephan, Ph.D, CEO, & Founder of NeuBase Therapeutics (NASDAQ: NBSE)

• • On February 3rd, our sister organization, Tribe Public hosted a Webinar Presentation and Q&A Event titled “Drugging The Genome.” The event was co-hosted by Dietrich A. Stephan, Ph.D, CEO, & Founder of NeuBase Therapeutics (NASDAQ: NBSE). The event video may now be viewed at the Tribe Public YouTube Channel at this link. 

• • 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.”