‘Uncle Jerry’ Trips Thursday’s Market Session With ‘Expeditious’ Views – $CYN $INM $INVO $NBSE $TSLA Rise!

 

 

 

 

Shares of Apple (AAPL) closed at $166.42, -.48%. On April 14, Apple announced that its suppliers more than doubled their use of clean power over the last year, with over 10 gigawatts operational today out of nearly 16 gigawatts in total commitments in the coming years. In 2021, these renewable projects avoided 13.9 million metric tons of carbon emissions. The projects online today will support greenhouse gas reductions equivalent to removing 3 million cars from the road for one year.

 

 

 

 

Shares of Tesla (TSLA) closed at $1,008.78, +3.23%. On April 20, Tesla reported that Q1 sales had jumped 81% even in the face of supply-chain disruptions, while Elon Musk promised a robotaxi for 2024. 

 

Tesla has plans for another stock split.  

 

 

The Walt Disney Company (DIS) closed at $121.66, -2.33%. Reportedly, the Florida Senate passed a bill to eliminate Disney special status. 

 

The Walt Disney Company will discuss fiscal second quarter 2022 financial results via a live audio webcast beginning at 4:30 p.m. ET / 1:30 p.m. PT on Wednesday, May 11, 2022. Results will be released after the close of regular trading on May 11, 2022. To listen to the webcast, please visit www.disney.com/investors.

 

On April 5, The Walt Disney Company named Kristina Schake as Executive Vice President, Global Communications, reporting to Chief Corporate Affairs Officer Geoff Morrell. She will be responsible for the Company’s worldwide communications strategy and operations, while also serving as lead spokesperson. Her appointment is effective immediately. Ms. Schake has spent three decades working at the nexus of government, media, business, entertainment, and technology. Most recently, she was appointed by President Biden to lead the nationwide COVID-19 vaccine education campaign and was previously Global Communications Director for Instagram. Ms. Schake was Deputy Communications Director for Hillary Clinton’s 2016 presidential campaign and served in the Obama administration as Special Assistant to the President and Communications Director to the First Lady.

 

Disney recently pledged to fight Florida’s ‘Don’t Say Gay’ legislation after the March 22 60 employee’s walkouts & social media campaigns to protest the company’s response to Florida legislation that would limit classroom discussion of sexual orientation or gender identity.

 

 

On the small side, Atossa Therapeutics (NASDAQ: ATOS), a clinical-stage biopharmaceutical company seeking to develop innovative proprietary medicines in oncology and infectious disease with a current focus on breast cancer and COVID-19, rose to an intraday high of $1.17 and closed at $1.05, -8.7% on 1.52M shares of trading volume.

 

On April 20, Atossa announced it has completed enrolling participants in Part B of its Phase 1/2a clinical study of AT-H201 in Australia, consisting of multiple ascending dose cohorts in healthy participants. AT-H201 is being developed as an inhalation therapy for moderately to severely ill hospitalized COVID-19 patients and for “long-haul” patients with post-infection pulmonary disease.“Part B of the study was successfully completed and, subject to approval from the ethics committee, we will now proceed to enroll the next group of participants,” said Steven Quay, M.D., Ph.D., Atossa’s CEO and President. “Despite widespread availability of vaccines, many areas of the world are seeing a recent surge in COVID-19 cases. There continues to be a strong need for additional therapies to combat COVID-19.” LEARN MORE. 

 

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

 

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

 

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

 

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

 

 

Shares of Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, closed at $34.52, -5.68%.

 

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. 

 

Shares of InMed Pharmaceuticals Inc. (NASDAQ: INM), a leader in the development, manufacturing and commercialization of rare cannabinoids, closed at $.98/share,, +2.94% after hitting a daily high of $1.41 as it traded 4.10M shares. 

 

Today, April 21, InMed announced it has launched B2B sales of the rare cannabinoid cannabidivarin (“CBDV”) to wholesalers, suppliers and end-product manufacturers in the health and wellness sector through its US subsidiary, BayMedica LLC. “Ensuring a reliable, large volume source of highly pure, bioidentical CBDV is an important step forward in the health and wellness sector. CBDV has been researched for its therapeutic potential in several disease areas such as autism spectrum disorder,” said Shane Johnson, MD, SVP and General Manager of BayMedica. “Whether you are a researcher or product developer at a multinational consumer package goods (‘CPG’) company, the ability to access highly pure and consistent active ingredients, free from contaminants typically found in plant-sourced cannabinoids such as pesticides, heavy metals, or potentially even THC, is a fundamental requirement. BayMedica’s cannabinoid manufacturing technologies provides exactly that value and we are excited to continue to introduce to the market additional rare cannabinoids that have previously not been abundantly accessible, including adding THCV to our portfolio in the immediate future.” LEARN MORE.

 

Per an sec.gov Form 4 filing Eric Adams, CEO of InMed purchased 8,650 shares of INM stock at $.85 on April 13, 2022. In addition, another Form 4 filing confirmed that Eric Adams, CEO of InMed also purchased 14,160 shares of INM stock at $.894 on April 14, 2022. He now owns a total of 59,003 shares. 

 

InMed Company’s executive team will be participating in several investor events throughout April and May 2022. LEARN MORE.

On March 17, InMed announced that its Chief Financial Officer, Mr. Bruce Colwill, will be retiring and will be stepping down from his position at the Company effective March 31, 2022. Mr. Colwill will continue to serve as an advisor through June 30, 2022 to facilitate a smooth transition. Ms. Brenda Edwards has been appointed as Interim Chief Financial Officer of the Company effective April 1, 2022. The Company has initiated a search for a full time replacement. Ms. Edwards brings over 35 years experience to InMed including over 20 years as a Chief Financial Officer of both private and public companies. Her experience includes merger and acquisitions, financings, managing high growth situations and financial reporting. She is a member of both the American Institute of CPAs and the Chartered Professional Accountants of Canada.

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

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

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

 

 

 

 

Shares of INmune Bio, Inc. (NASDAQ: INMB), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, closed at $6.93, -6.85%.

 

On April 13, INmune bio announced dosing of the first patient enrolled in its Phase 2 trial using XPro1595 (XPro™) to treat neuroinflammation as a cause of Alzheimer’s disease (AD). The Phase 2 multicenter, international trial is a blinded, randomized, placebo-controlled six-month Phase 2 trial designed to evaluate XPro™ to treat cognition and function in patients with mild AD and biomarkers of inflammation. The company plans to enroll patients at sites located near major metropolitan areas in Australia, in Canada and in the United States. “The Phase 1 study data clearly showed an improvement in multiple biomarkers related to AD pathology, including a reduction in neuroinflammation and neurodegeneration, and an improvement in biomarkers of neurorepair and neuron communication,” said Dr. C.J. Barnum, INmune Bio’s Vice President of CNS Development. “This Phase 2 study will determine whether improvement in these biomarkers translates into a clinical benefit of improved cognition and function in patients with mild AD and biomarkers of inflammation.”

 

On April 11, INmune Bio announced data demonstrate that INmune Bio’s INB03 reverses MUC4 experssion in HER2+ BC cell line (JIMIT-1) to re-establish sensitivity to trastuzumab (traz) and tyrosine kinase inhibitors (TKI). Mucin 4 (MUC4), a glycoprotein is an easily measured biomarker in women with breast cancer. Previously, INmune Bio reported MUC4 expression predicts worse survival in women with HER2+ BC (p≤0.04). Study results show this new evaluation focused on the effects of MUC4 expression on the immune cells of the tumor microenvironment (TME) in HER2+ BC. These data were presented here today at the American Association of Cancer Research Annual Meeting in 2022, held in New Orleans April 8-13. The findings of this study predict that women with MUC4+/HER2+ BC are expected to have fewer tumor infiltrating lymphocytes (TILs) than women who do not express MUC4 (p=0.018). In a nude mouse model of MUC4+HER2+ BC, the combination of INB03+traz increased the number of activated NK cells (p=0.01) and anti-tumor macrophages (p=0.01) in the TME. In this nude mouse model, anti-tumor macrophage function is more important than NK cell function in controlling tumor growth. Dr. Roxana Schillaci of Instituto de Biología y Medicina Experimental in Buenos Aires stated, “We have previously shown that MUC4 expression correlates with resistance to traz and TKI. We can add third resistance mechanism to the list – an immunologically “cold” TME. These three resistance mechanisms are driven by soluble TNF produced by the tumor and are reversed by INB03 in the animal models.” RJ Tesi MD, CEO of INmune Bio stated, “Resistance to immunotherapy occurs in about a third of women with HER2+ BC. MUC4 is a biomarker of resistance that can be determined from the patient’s biopsy. Identifying a modifiable resistance factor early may allow the clinical team to optimized immunotherapy to improve outcome.”

 

On April 4, INmune Bio highlighted key findings from the NK Cells in Solid Tumors workshop. Dr. Mark Lowdell, INmune Bio’s Chief Scientific Officer (CSO), led the workshop on the role of NK cells in treatment of solid tumors during the Innate Killer Summit in San Diego (March 30 -April 1, 2022). The conference is widely viewed as one of the most important in translational NK cell immunotherapy. Two consistent themes of this year’s conference were the importance of memory-like NK cells and the poor in-vivo survival of adoptively transferred allogeneic NK cells, with or without genetic modification. Strategies to improve NK cell “fitness” and improve NK cell metabolism were at the forefront. NK cell dysfunction and poor survival in the recipient and, in particular the TME may be due to damaged mitochondria – considered the “powerplants” of the cell that are essential for survival. Dr. Lowdell observed that INKmune™, unlike IL15 and other NK-activating cytokines, simultaneously upregulates all mitochondrial survival proteins and more than 40 nutrient receptors on the NK cell. These unique changes may help INKmune-primed NK cells survive and thrive in the hypoxic immunosuppressive TME. Data from patients treated with INKmune™ have shown tumor killing memory-like NK cells present in peripheral blood and bone marrow for at least 15 weeks after INKmune™ therapy and provoked a lot of discussion about whether INKmune™ can be used in combination with adoptive NK therapies to sustain the memory-like phenotype and increase survival.

 

 

 

Since the last Innate Killer Summit, INmune has treated three patients with INKmune™ The first MDS patient, a 74-year-old man, remains stable 9 months after therapy. Updated results at the lowest dose cohort of INKmune treatment at day 119 show: NO side effects – NO evidence of alloresponse to INKmune™, Evidence of disease control and maintenance of MRD after 3 doses, Improved BM function – No G-CSF / Platelet independent, Improved ECOG score from 2 to 0, Production of tumor killing memory like NK cells., & Persistence of activated NK cells in blood to Day 119 at least. The company also reported that a 21-year-old female with relapsed AML and mixed chimerism after stem cell transplant reestablished 100% donor chimerism after INKmune™ therapy. She remains under close observation as an out-patient more than 6 months after INKmune™ therapy. The third patient, a young man with AML who failed two transplants remains desperately ill. “The Innate Killer Summit is the best place to share our data and discuss our pre-clinical and clinical results with the community of scientists developing NK-based immunotherapies”, added Dr Lowdell.

 

On March 25, INMB announced reviews findings from data presented at AD/PD™ 2022 – International Conference on Alzheimer’s and Parkinson’s diseases. The AD/PD™ 2022 International Conference was from March 15-20 in Barcelona, Spain. “The field of AD is changing rapidly as treatments beyond amyloid and tau are explored. Targeting neuroinflammation, the use of biomarkers, and novel clinical trial designs are changing the way drugs are developed for this challenging disease,” said R.J. Tesi, INMB’s CEO. “In my opinion, there are three key observations that put the nine presentations by INmune Bio in perspective. We remain convinced that targeting glial activation with Xpro™ is a smart strategy.”

 

On March 23, eight Form 4’s were filed representing a significant increase in insider buying in INMB’s stock. Please see filings at the direct link at sec.gov. 

 

On March 15,  INmune Bio announced nine pieces of data, including oral symposia, would be presented at AD/PD™ 2022 – International Conference on Alzheimer’s and Parkinson’s diseases. The AD/PD™ 2022 International Conference is being held from March 15-20 in Barcelona, Spain. Raymond J. Tesi, Ph.D, Chief Executive Officer of INmune Bio, commented, “This is the first time many clinician teams in Europe and UK have been exposed to XPro™ and INmune Bio’s approach to treatment of Alzheimer’s Disease,” said RJ Tesi. “These nine presentations show the versatility of XProTM and the importance of neuroinflammation in the pathogenesis of neurodegenerative disease. The presentations provide a great overview of XPro™ for the treatment of AD, introducing the novel biomarkers INmune is using, and how the results of the Phase I trial provided insight into the design the Phase II trials in mild cognitive impairment and Mild Alzheimer’s.” LEARN MORE HERE. 

 

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. “These patients demonstrate the unique attributes of INKmuneTM therapy in patients with high-risk MDS/AML. INKmuneTM converted the patient’s resting NK cells into cancer killing memory like NK cells. The memory like NK cells killed NK-resistant cancer cells in an in vitro assay. Both these attributes lasted four months, a trait we are calling therapeutic persistence.” stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. “We are continuing to screen patients for enrollment into the trial and are in process of expanding the number of clinical trial sites.”

 

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.”

 

Shares of INVO Bioscience, Inc. (NASDAQ: INVO), a commercial-stage fertility company focused on expanding access to advanced treatment worldwide with its INVOcell® medical device and the IVC procedure it enables, closed at $1.64, but then tried up to $1.83, +11.59% in the aftermarkets.

 

On April 14, INVO Bioscience announced plans to open an INVO Center in Kansas City, Missouri. The Kansas City INVO Center will focus on patients in need of advanced fertility care utilizing the efficient, effective, and affordable INVOcell® solution. The Company currently has three operational INVO Centers treating patients in Birmingham, Alabama, Atlanta, Georgia, and Monterrey, Mexico, with others scheduled to open in the San Francisco and Tampa areas. The Company evaluates several criteria and data points as part of its efforts to identify markets suitable for INVO Centers. Based on an analysis of current population statistics, we believe that Kansas City may have upwards of 33,000 patients suffering with Infertility. With an estimated 1,500 IVF treatments annually, there exists a large gap of available care to treat local demand. Similar to other INVO Centers, the Company expects to engage physician partners to support its efforts in the Kansas City market.

 

 

 

INVO Bioscience recently exhibited the INVOcell solution at the 2022 Pacific Coast Reproductive Society (PCRS) Annual Meeting that took place March 23-27 at the Renaissance Esmeralda Resort & Spa in Indian Wells, CA. Chris Myer, INVO’s Senior VP, Business Development, Americas, and Bojan (Bo) Mitrovic, PhD, INVO’s Director, Sales, US both were available in Booth #314 discussing INVOcell with the broader Assisted Reproductive Technology (ART) physician community.
Steve Shum, CEO of INVO Bioscience, commented, “A key component to our go forward commercialization strategy is to synchronize and take an expanded, more comprehensive and direct approach toward our U.S. efforts. PCRS provides us an opportunity to easily connect with a number of U.S. IVF clinics that have already trained on the INVOcell device and the IVC treatment process, as well as introduce our solution to additional clinic operators interested in expanding their treatment options and overall capacity by introducing INVOcell to patients.” Pacific Coast Reproductive Society is a multidisciplinary medical specialty society providing Continuing Medical Education (CME) to physicians and allied healthcare professionals. The PCRS Annual Meeting provides an outstanding forum for the exchange of information and the advancement of the ideologies of reproductive medicine in a relaxed and collegial setting. Session topics have been carefully selected to bring you the highest quality, innovative CME, designed and presented by thought leaders in reproductive medicine.

 

 

 

On January 19, Maxim Group’s sell side analyst Jason McCarthy, Ph.D. initiated coverage with a Buy Rating Report titled “INVO Bioscience: Transforming Assisted Reproductive Technology with Intravaginal Culture” with a $7 Price Target.

 

Shares of NeuBase Therapeutics (NASDAQ: NBSE), a biotechnology platform company Drugging the Genome™ to address disease at the base level using a new class of precision genetic medicines, closed at $1.45, +.69% and has traded up to $1.55, +6.9% in the aftermarkets. The 52-wk range is $1.21-$6.60.

 

On March 16 and March 17, recently appointed Neubase CFO, Todd Branning (Jan. 10 , 2022),  purchased 10,000 shares of NBSE stock each day for a total of 20,000 shares at $1.62/share and $1.74/share respectively. Here’s the Form 4 filing at the SEC. 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 March 13, Neubase announced new preclinical data for its lead development candidate, NT-0231.F, to treat myotonic dystrophy type 1 (DM1). These data are being presented in poster and oral presentations at the 2022 MDA Clinical & Scientific Conference, which is taking place virtually and in-person in Nashville, Tennessee from March 13-16, 2022. These data was presented at the RNA Leaders World Congress in Basel on March 17th. 

 

Sandra Rojas-Caro, M.D., Chief Medical Officer of NeuBase, said, “DM1 is a significant unmet medical need characterized by myotonia, muscle weakness and wasting, and cognitive impairments. We are excited to present new preclinical data for our lead candidate, NT-0231.F, to support our differentiated approach for DM1. Systemic administration of NT-0231.F achieves clinically relevant molecular and functional rescue in the muscle in the HSALR model, which reproduces many components of the disease. Initial pharmacokinetic data supports a whole-body solution to the disease, and additional preclinical work is in progress to assess biodistribution in key tissues. These data are an important milestone in our DM1 development program and support our pursuit of a best-in-class therapeutic profile for the disease.”

 

A single intramuscular dose confirmed that NT-0231.F is pharmacologically active in the muscle and drives molecular and functional rescue in the HSALR model, including splice rescue, nuclear aggregate resolution, and myotonia (delayed muscle relaxation after contraction) reversal. A single intravenous (IV) dose of NT-0231.F or multiple subcutaneous (SC) doses over a 28-day period broadly rescued splicing, including the chloride channel (Clcn1) transcript, and reversed myotonia in the model. A single IV dose of NT-0231.F provides initial splice rescue at around two weeks, with significant splice rescue around three weeks. Myotonia reversal was achieved at around four weeks, with effects enduring to at least six weeks, the longest time point tested so far. A time course of multiple SC doses across increasing concentrations of NT-0231.F was also investigated and showed splice rescue and myotonia reversal in a dose-responsive manner, illustrating feasibility of the differentiated and patient-friendly SC route. In pharmacokinetic studies of NT-0231.F in wild-type BALB/C mice, a single IV or SC dose showed high volume of distribution, suggesting wide tissue distribution. 

 

Dietrich A. Stephan, Ph.D., Founder, Chief Executive Officer, and Chairman of NeuBase, said, “We now have preclinical data in the gold-standard animal model for our development candidate demonstrating robust reversal of myotonia, as measured by muscle relaxation in these studies. We believe we are the only company that has shown improved muscle relaxation after systemic routes of administration. The HSA^LR model is also a high bar for human disease in that it contains at least 10x more mutant gene CUG- repeat targets than patients, giving us further conviction in the robustness of our approach. Not only does this data support the further advancement of our lead program in DM1 and keep us on track for submitting an Investigational New Drug application to the U.S. Food and Drug Administration in 4Q CY2022, it also validates that we can utilize our PATrOL^TM platform to design novel genetic medicines that target and rescue many other gene dysfunctions, with the potential for clinically impactful outcomes in both rare and common diseases.”

 

 

 

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.

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