A Bit of Red Served During Tuesday’s Market Session As Oil & $AMC Continue Higher!

VP WATCHLIST HIGHLIGHTS

You can review our complete VP Watchlist that we believe deserve consideration for short term and long term portfolio adds that include Apple, Tesla, & seven other names. The pages will enable you to stay informed and learn more about these companies daily.

Please review few of the updates on a few of the VP Watchlist companies below: 

• INmune Bio, Inc. (NASDAQ: INMB) closed at $18.01, -3.38% after touching $18.78 in intraday trading and up significantly since we added them recently in the $9 range in the May. INMB is a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease. INMB is further focused on modulating components of the innate immune system to activate an immune response against cancer and Alzheimer’s disease.

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

• • INMB closed Q1/2021 with cash of $45.3M, which management believes is enough to fund operations into Q4/2022. Per our beliefs, INMB’s biggest value generator is its Phase 1 AD program, with additional results due later this year and their Phase 2 to start in in the 2nd half of this year.  

• • With the June 7th FDA approval of Biogen’s (BIIB) controversial and much debated Alzheimer’s Drug, the focus on the AD space has been turned up and it is likely that INMB’s program and others in the space will be found to a greater degree. 
    

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

• • On May 18th, I hosted Immune Bio’s CEO RJ Tesi at the Tribe Public Presentation & Q&A Event for a fascinating discussion and his presentation titled “Advancing Treatment To Repair Our Aging Innate Immune System to Fight Alzheimer’s.” Please view the event video here. 

• • INmune Bio’s DN-TNF product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and mechanistic target of many diseases. DN-TNF is in clinical trial to determine if it can treat for COVID-19 complications (Quellor™), cancer (INB03™), Alzheimer’s and treatment resistant depression (XPro595), and NASH (LIVNate™). The Natural Killer Cell Priming Platform includes INKmune™ aimed at priming the patient’s NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic malignancies, solid tumors and chronic inflammation.

• • INMB reported its financial results for the first quarter ended March 31, 2021 and provided a business update on Wednesday, May 5th. RJ Tesi, M.D., chief executive officer of INmune Bio stated, “We continued to treat patients in the Phase I XPro1595 Alzheimer’s disease trial and expand the extensive biomarker data. The interim data that we reported in January confirms that XPro1595 decreases neuroinflammation in patients with Alzheimer’s disease and supports transitioning to a blinded randomized placebo-controlled Phase II trial later this year. We regard these results as extremely promising and look forward to further confirmation of XPro1595’s potential benefit to these patients in a rigorously designed Phase 2 study. We will report the additional biomarker data later this Summer. We have started screening patients in the Phase I INKmune NK cell priming platform trial in patients with high-risk myelodysplastic syndrome (MDS). MDS is a serious hematopoietic stem cell disorder in which patients have functionally defective NK cells, and approximately one-third of cases progress to AML. We created a short 5-minute video that we believe does a wonderful job explaining why NK cells fail to clear cancer and how the cellular and molecular interactions by INKmune activate NK cells to kill resistant tumors. The video can be found by clicking here.”

• Natural-Killer cell (NKcell) focused biopharmaceutical firm Fate Therapeutics (FATE) closed at $86.79/share, -3.53%. The 52-wk high is $121.16. 

  • Today, June 15th, FATE announced that Mark Plavsic, DVM, PhD, RAC has been appointed Chief Technical Officer. Dr. Plavsic brings over 20 years of broad technical excellence in global biopharmaceutical operations, having led teams in the commercial-scale cGMP manufacture and distribution, as well as the clinical-stage process, assay, and formulation development, of complex biologics. As Chief Technical Officer, Mark will oversee the Company’s manufacturing, technical, and supply chain operations.

• • On June 4th, FATE highlighted positive interim Phase 1 data from the Company’s FT516 program for patients with relapsed / refractory B-cell lymphoma at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting being held virtually June 4-8, 2021. FT516 is the Company’s universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor, which is designed to maximize antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells. The ongoing Phase 1 dose-escalation study of FT516 is currently enrolling patients in the fourth dose cohort of 900 million cells per dose.IN summary they highlighted that 8 of 11 Patients in Dose Escalation Cohorts 2 and 3 Achieved Objective Response, 6 of 11 Patients Achieved Complete Response, including 2 Patients Previously Treated with Autologous CD19 CAR T-cell Therapy, & Favorable FT516 Safety Profile Was Observed; No FT516-related Serious Adverse Events or FT516-related Grade 3 or Greater Adverse Events.

  • On May 13th, FATE announced encouraging interim Phase 1 data from the Company’s off-the-shelf, iPSC-derived natural killer (NK) cell programs in relapsed / refractory acute myeloid leukemia (AML). The ongoing Phase 1 dose-escalation study of FT516 as monotherapy is currently enrolling patients in the third dose cohort (900 million cells per dose), with three patients treated in the first dose cohort (90 million cells per dose) and six patients treated in the second dose cohort (300 million cells per dose). The Phase 1 dose-escalation study of FT538 as monotherapy is currently ongoing, with three patients treated in the first dose cohort (100 million cells per dose). As of the data cutoff date of April 16, 2021, five of 12 patients had achieved an objective response with complete leukemic blast clearance in the bone marrow (FT516 [n=9]: 3 complete remission with incomplete hematologic recovery [CRi], 1 morphologic leukemia-free state [MLFS]; FT538 [n=3]: 1 CRi). Of the four patients achieving a CRi, one patient successfully proceeded to allogeneic stem cell transplant and the other three patients remained on-study and in remission without further therapeutic intervention, two of whom remained in remission having been on-study for more than six months. Clinical assessments were based on the 2017 European LeukemiaNet (ELN) response criteria (Blood (2017) 129 (4): 424–447). Importantly, no dose-limiting toxicities, and no cases of any grade of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or graft-versus-host disease, were observed.

  • On May 5th, Fate reported business highlights and financial results for the first quarter ended March 31, 2021. Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics stated, “During the first quarter of 2021, we strengthened our balance sheet by raising $460 million and successfully positioned our off-the-shelf, iPSC-derived NK cell pipeline to achieve significant clinical milestones across our disease franchises throughout the remainder of the year. We look forward to sharing Phase 1 clinical data from our FT516 and FT538 programs in relapsed / refractory AML at an investor event to be held alongside the ASGCT conference. We are also pleased with the clinical expansion of our FT538 program into solid tumors, where we plan to combine with FDA-approved monoclonal antibodies targeting EGFR, HER2, and PDL1. While we are disappointed that the PROTECT study of ProTmune did not meet its primary endpoint for prevention of acute graft-versus-host disease following allogeneic stem cell transplant, we will now turn our full attention and resources to our deep pipeline of off-the-shelf, iPSC-derived cancer immunotherapies. We would like to sincerely thank the patients, caregivers and investigators who participated in the clinical investigation of ProTmune, and we intend to share our clinical findings with that community.”

• • On Jan. 8th, FATE announced the pricing of an underwritten public offering of ~$432 million at $85.50/share. Jefferies, BofA Securities, SVB Leerink and Barclays acted as joint book-running managers for the offering.

• INVO Bioscience (NASDAQ: INVO) is 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. Shares of INVO closed at $4.54/share.

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

• • On May 17, INVO announced financial results for the first quarter of 2021 ended March 31, 2021 and provides a business update. Steve Shum, Chief Executive Officer of INVO Bioscience stated, “This was an exciting start to the year 2021 for INVO Bioscience as we advanced our INVO Clinic strategy with the signing of our first U.S.-based INVOcell exclusive facility in Birmingham, Alabama, the signing of a partnership agreement to establish and operate a center in Northern California, and the completion of our product registration in Mexico. We expect these initial centers to become operational in the second half of the year. Throughout this year, we have expanded our real-world experience data and positive results with INVOcell, enhanced our online training tools, materials, and capabilities and have experienced a substantial increase in active training sessions for our international partners and distributors. We believe the combination of strong commercialization partnerships and company-owned clinics, both in the U.S. and around the world, is key to expanding INVOcell’s adoption within the fertility industry. In addition to the progress made executing new commercialization agreements, we have strengthened our marketing capabilities to support the INVOcell-only centers and our growing number of distribution partners. Meryle Lynn Chamberlain, a tenured women’s health and fertility solution marketing professional, joined us as Director of Marketing in March 2021, while Rebecca Messina, current Senior Advisor at McKinsey & Co. and former Global Chief Marketing Officer at both Uber and Beam Suntory joined our board of directors in April 2021. As we look to increase access to care and expand fertility treatment across the globe, our market positioning and overall strategies are more important than ever. The addition of Meryle Lynn and Rebecca will enhance our ability to successfully accomplish these goals. As we look to the remainder of 2021, we have set a number of key objectives, including the opening of our first company-owned clinics in Mexico and the United States. Additionally, we will seek to build our international revenues this year through our growing list of international distribution partners as they finish training, and we complete local product registration requirements. Of note, we are extremely pleased to see the initial INVO procedures performed recently in Spain and Malaysia, which reflects the groundwork done by our team in these specific markets, which we believe will help in further expanding the overall awareness of the potential outside of the U.S. Finally, we are continuing to advance our 5-day label expansion efforts with the FDA in the U.S. market with a goal of completing this effort in 2021. It remains our belief that there is strong global demand for fertility services and INVOcell is well-positioned through our growing, global footprint to play a key role in helping to turn the dream of creating a family for millions of people around the world into a reality through our accessible, efficient, and affordable fertility treatment.”

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

• • On April 13,  I hosted INVO’s CEO Steve Shum at the Tribe Public CEO Presentation – Q&A Webinar Event where he delivered his presentation is titled “Democratizing Infertility – A Severely Underserved Global Market.” You may view the video of the event now at his link: https://youtu.be/w4yQIc7eO5k.

• • 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.

• Shares of Chinook Therapeutics (KDNY), a clinical-stage biotechnology company developing precision medicines for kidney diseases, closed today at $16.43, -2.32%. KDNY touched a 52-wk high of $21.68 in Dec. 2020 and has been roughly trading in the $14 and change range up to this level after uplisting to the NASDAQ in fall of 2020. It will be interesting to see if can break though the this level as it moves forward with several milestones in the back half of 2021. 

• • On June 8th, KDNY announced the presentation of data from the ongoing phase 1/2 study of BION-1301 in patients with IgAN. The findings were presented in an oral presentation at the 58th European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Virtual Congress. here are the highlights: 1) BION-1301 has been well-tolerated to date in patients with IgAN, with no serious adverse events (SAEs) or treatment discontinuations due to adverse events, 2) Pharmacokinetics (PK) of BION-1301 observed in patients with IgAN are consistent with those previously reported in healthy volunteers and are sufficient to drive rapid and sustained reductions in free APRIL levels, 3) BION-1301 has durably reduced Gd-IgA1, IgA, IgM, and to a lesser extent, IgG levels in patients with IgAN, & 4) BION-1301 has demonstrated a clinically meaningful mean reduction in 24-hour proteinuria (UPCR) in the first several patients enrolled in the study, providing initial proof-of-concept for BION-1301 in IgAN.

• • On May 12, Chinook provided a business update and reported financial results for the first quarter ended March 31, 2021 today. Eric Dobmeier, president and chief executive officer of Chinook Therapeutics stated, “During the first quarter of 2021, Chinook made strong progress with its pipeline of programs for kidney diseases, including initiating the phase 3 ALIGN and phase 2 AFFINITY trials of atrasentan, presenting encouraging clinical data from the BION-1301 program and entering into a strategic collaboration with Evotec. We are well-capitalized and resourced to execute across our programs to generate additional data catalysts and continue building Chinook into a leading kidney disease company.”

• • On April 15, Chinook announced six poster presentations at the ISN World Congress of Nephrology 2021 (WCN ’21). Eric Dobmeier, president and chief executive officer of Chinook stated, “The depth and breadth of our presence at this year’s WCN ’21 is a testament to Chinook’s role as a leading kidney disease company. Our data demonstrating BION-1301’s ability to significantly reduce Gd-IgA1 levels in healthy volunteers, as well as the favorable pharmacodynamics of subcutaneous administration of BION-1301, position the program well to move forward in demonstrating its disease-modifying potential for IgA nephropathy patients. In addition, our preclinical poster presentations on atrasentan provide broader insights into its anti-fibrotic and anti-inflammatory properties that are additive and complementary to its proteinuria-lowering mechanism of action.”

• • On April 15, Chinook’s CEO Eric Dobmeier  & CBO Tom Frohlich delivered a presentation titled “Revolutionizing The Treatment of Kidney Disease” followed by a Q&A session at the Tribe Public Network. You can view the video of the event here. 

• • On April 7, KDNY provided a business update and reported financial results for the full year ended December 31, 2020. Eric Dobmeier, President and chief executive officer of Chinook Therapeutics stated, “We are executing well on our goal of building Chinook into a leading kidney disease company. 2020 was a very busy and productive year, as we in-licensed atrasentan from AbbVie, closed a $115 million financing, brought BION-1301 into our pipeline through the merger with Aduro, unveiled CHK-336, our first internally-developed program, and bolstered our precision medicine discovery and research efforts. We are excited to have recently initiated our atrasentan phase 3 ALIGN and phase 2 AFFINITY trials and announced our collaboration with Evotec. We look forward to multiple data announcements from our BION-1301 program this year, as well as continuing to move CHK-336 towards the clinic. Our team has grown over 300 percent since the beginning of 2020, and we’re continuing to execute on our hiring plans to ensure we have strong resourcing in place to advance our pipeline. Our solid cash position, which we expect to fund our operations to the middle of 2023, enables us to achieve key milestones across our programs.”

• • On Monday, April 5th, KDNY announced a transaction with Van Herk Investments, a leading European life science investor, to create and fund a new company called Sairopa, with a pipeline focused on research and development of non-renal monoclonal antibodies generated through Aduro Biotech’s B-Select platform. Chinook will own approximately 40 percent of Sairopa after the first tranche of financing from Van Herk and have one seat on Sairopa’s Board of Directors.

• • On March 16, Chinook announced that the first patient with IgA nephropathy (IgAN) has been enrolled in the ALIGN Study, a pivotal phase 3 clinical trial evaluating the efficacy and safety of atrasentan, a potent and selective inhibitor of the endothelin A receptor. “The initiation of the phase 3 ALIGN Study is an important milestone for Chinook as we advance our pipeline of programs for rare, severe chronic kidney diseases,” said Alan Glicklich, M.D., chief medical officer of Chinook. “Atrasentan has been studied in over 5,300 diabetic kidney disease patients in the phase 2 RADAR and phase 3 SONAR studies, demonstrating rapid, sustained proteinuria reductions of approximately 30 to 35 percent as well as improved eGFR. Importantly, treatment with atrasentan also resulted in a reduction in clinical outcomes of development of end-stage kidney disease and doubling of serum creatinine. We look forward to exploring the proteinuria-lowering, anti-inflammatory and anti-fibrotic effects of atrasentan in patients with IgA nephropathy, a serious progressive disease for which there are no approved therapies.”

  • On March 1, Chinook and Evotec SE announced a strategic collaboration focused on the discovery and development of novel precision medicine therapies for patients with chronic kidney diseases. Based on Evotec’s proprietary comprehensive molecular datasets from thousands of patients across chronic kidney diseases of multiple underlying etiologies, Chinook and Evotec will jointly identify, characterize and validate novel mechanisms and discover precision medicines for PKD, lupus nephritis, IgA nephropathy and other primary glomerular diseases. The collaboration will also involve further characterization of pathways and patient stratification strategies for programs currently in Chinook’s clinical and preclinical pipeline. “We are excited to embark on this strategic collaboration with Evotec, the leading drug discovery alliance and development partner in nephrology,” said Andrew King, D.V.M., Ph.D., Head of Renal Discovery and Translational Medicine at Chinook. “Gaining access to the NURTuRE cohort study and other proprietary patient biobanks, along with Evotec’s multi-omics integration platform, will enable us to define the molecular drivers of kidney diseases, identify novel targets for drug development in selected patient sub-populations and continue to build the foundation for our precision medicine approach. With a focus on comprehensive molecular disease classification, combined with prospective clinical outcomes, Chinook has the opportunity to potentially deliver targeted therapies to the right patient populations.”

• • On Feb. 2nd, Chinook announced that the U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designation for CHK-336, an investigational oral small molecule inhibitor of lactate dehydrogenase A (LDHA) for primary hyperoxaluria (PH). PH is a group (PH1, PH2 and PH3) of ultra-rare genetic diseases caused by enzyme mutations that result in excess oxalate production in the liver, and in its most severe forms, can lead to end-stage kidney disease at a young age. Inhibition of LDHA with CHK-336 allows for the potential to treat all forms of PH and other disorders arising from excess oxalate, while its liver-targeted tissue distribution profile enables maximal inhibition of liver oxalate production with minimal systemic exposure. Please read the story here.

• Shares of Seattle-based 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 $4.62.

• On June 9th, Atossa’s CEO Dr. Steven C. Quay, M.D., Ph.D., CFO Kyle Guse, & B. Heather Fraser, Ph.D. VP Clinical, Regulatory & CMC presented at a Tribe Public Presentation & Q&A Event titled “Discussion of Atossa’s Final Data from its Phase 2 Study of Endoxifen Administered to Breast Cancer Patients Prior to Surgery.” The event took place after the company announced, announced the final data from its Phase 2 clinical study of oral Endoxifen administered in the “window of opportunity” between diagnosis of breast cancer and surgery. You may view the event video at the Tribe Public YouTube Channel by clicking this link now. 

• • On Friday, June 11th, Atossa announced that it has received approval from the Swedish Medical Product Agency (MPA) to initiate a Phase 2 clinical study of its oral Endoxifen for the reduction of mammographic breast density (MBD). Studies conducted by others have shown that MBD reduces the ability of mammograms to detect cancer (sensitivity) and increases the risk of developing breast cancer. Additional studies show a correlation between reducing MBD and a reduction in the incidence of breast cancer. The primary objective of the MBD study is to determine the dose-response relationship of daily oral Endoxifen on mammographic breast density reduction, with secondary endpoints assessing safety and tolerability. The Phase 2 study will be randomized, double-blinded and placebo-controlled. It will be conducted in Stockholm and will include approximately 240 pre-menopausal women with measurable MBD who will receive daily doses of oral Endoxifen or placebo for six months. South General Hospital in Stockholm will be conducting the study. The study is being led by principal investigator Per Hall, M.D., Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet. The study is also subject to approval by the institutional ethics committees and enrollment will not begin unless and until all approvals are obtained and COVID restrictions are lifted in Sweden.

• • On May 27th, DRASTIC Investigator Gilles Demaneuf and Physician-Scientist Dr. Steven C. Quay, M.D., Ph.D., CEO of Atossa Therapeutics (NASDAQ:ATOS), announced that they have published new research that addresses the question of whether the claim that there were no COVID cases at the Wuhan Institute of Virology (WIV) is legitimate. Given that it has been reported there were about 590 staff members working at the WIV at that time and the documented prevalence of COVID in Wuhan during the first half of 2020 of 4.4%, it is statistically impossible that there were no cases. The research can be read here.

• • On April 8, Atossa announced that an ovarian cancer patient has begun treatment with Atossa’s proprietary oral Endoxifen. The FDA previously issued a “Safe to Proceed” letter under their expanded access pathway, permitting the use of Atossa’s oral Endoxifen in this patient. The patient is being treated at the University of Washington Medical Center by Dr. Barbara Goff, Surgeon-in-Chief. “The patient has recurrent ovarian cancer and did not tolerate tamoxifen, which is sometimes prescribed for ovarian cancer as well as breast cancer,” commented Steven Quay, M.D., Ph.D., Atossa’s President and CEO. “The patient recently underwent functional molecular genomic testing using 3D tumor organoid cultures grown in the laboratory from the patient’s tumor to help determine potential therapies. This testing revealed that the combination of Endoxifen and alpelisib produced an exceptional tumor response. We will follow the progress of this patient and consider additional clinical studies in patients with ovarian cancer.” Under the FDA expanded access program, the use of Atossa’s proprietary oral Endoxifen is restricted solely to this patient.

• • On March 11, Atossa announced the FDA has issued a “Safe to Proceed” letter under their Expanded Access Pathway, permitting the use of Atossa’s oral Endoxifen as a treatment in an ovarian cancer patient. The patient is being treated at the University of Washington Medical Center by Dr. Barbara Goff, Surgeon-in-Chief. Under the FDA expanded access program, the use of Atossa’s proprietary oral Endoxifen is restricted solely to this patient. Approval from the Institutional Review Board (IRB) must be obtained prior to providing oral Endoxifen to this patient. Read the complete story.

• • On Feb. 25, Atossa announced final results from its Phase 1 double-blinded, randomized, placebo-controlled clinical study using Atossa’s proprietary drug candidate AT-301 administered by nasal spray. AT-301 was considered to be safe and well tolerated in healthy male and female participants in this study at two different dose levels over 14 days. AT-301 is being developed for at home use for patients recently diagnosed with COVID-19. There are currently no FDA-approved therapies to treat COVID-19 at home. Steven Quay, M.D., Ph.D., Atossa’s President and CEO stated, “The results from this study are very encouraging and we look forward to quickly commencing the next study of AT-301. We recently received input from the FDA on this program and based in part on that input, we are now preparing to conduct an additional pre-clinical study, which we expect to start this quarter. Following that, we expect to apply to the FDA to commence a Phase 2 study here in the United States.”