Thirsty Thursday Pushes Markets & VP Watchlist Stocks Higher- ($AAPL $ATOS $DIS $FATE $INMB $HL $INVO $KDNY $TSLA)

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 $12.76, +11.83% after touching $13.26 in intraday trading. 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.
  

• • 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 $77.25/share, +2.56%.

  • On May 13, 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 April, 27th the company announced that two oral and two digital presentations of the Company’s induced pluripotent stem cell (iPSC) product platform were accepted for presentation at the 24th American Society of Gene & Cell Therapy Annual Meeting (ASGCT) being held virtually from May 11-14, 2021. In addition to the Company’s presentations at ASGCT, its iPSC-derived natural killer (NK) cell product pipeline is expected to be featured in a meeting symposium on May 11 by Jeffrey S. Miller, M.D., Professor of Medicine, University of Minnesota and Deputy Director of the Masonic Cancer Center and scientific advisor and collaborator of the Company, and its iPSC-derived CAR T-cell product platform is expected to be highlighted during the meeting’s plenary session on May 12 by Michel Sadelain, M.D., Ph.D., Stephen and Barbara Friedman Chair and Director, Center for Cell Engineering, Memorial Sloan Kettering Cancer Center and collaborator of the Company. The Company also plans to host a virtual investor event on May 13 to highlight interim Phase 1 clinical data from its FT516 and FT538 programs for the treatment of relapsed / refractory acute myeloid leukemia (AML). The Phase 1 clinical trial of FT516 has enrolled the first and second dose cohorts (90 million and 300 million cells per dose, respectively), and dose escalation is ongoing in the third dose cohort (900 million cells per dose). The Phase 1 clinical trial of FT538 is ongoing in the first dose cohort (100 million cells per dose).

• • On March 25, FATE announced that Daniel D. Shoemaker, Ph.D., Chief Scientific Officer, has advised the Company that he is retiring as of June 30, 2021 after more than 12 years with the Company. Dr. Shoemaker has been with Fate Therapeutics since February 2009, having served as the Company’s Chief Scientific Officer since May 2015. Bob Valamehr, Ph.D., Chief Research and Development Officer of Fate Therapeutics and scientific leader of its iPSC Product Platform since January 2010, will continue to lead all research and development activities.

• • On Jan. 8, 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 $4.20/share, +.96% today. 

• Could we be setting up for another March 9, 2021 type of run where +96M shares traded for this low-float stock (~10.4M shares are issued and outstanding) & the stock shot to a new 52-week high of $12.30….?

• • 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 $17.49, +3.68.

• • 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 $3.25, +.62%.

• • On May 14, Atossa announced financial results for the fiscal quarter ended March 31, 2021, and provided an update on recent company developments. Dr. Steven Quay, Atossa’s President and Chief Executive Officer stated, “During the first quarter of 2021 we continued our two key development programs, namely our Phase 2 study of oral Endoxifen for the ‘window of opportunity’ between diagnosis of breast cancer and surgery and our Phase 1 study of AT-301 nasal spray for at-home use for patients recently diagnosed with COVID-19. In addition, we continued our ongoing expanded access program with Endoxifen in which the drug continues to be well tolerated and breast cancer recurrence has not been seen clinically. We also received an important authorization from the FDA for an additional expanded access treatment program in an ovarian cancer patient. Combined with very encouraging results in our COVID-19 program with AT-301 nasal spray, we continued to make great progress over the quarter.In the meantime, we leveraged favorable conditions in the capital markets to strengthen our balance sheet over the last few months placing Atossa in a good position to execute on these and potential additional business opportunities during the remainder of 2021. As a result, we are diligently moving our existing programs forward, while actively exploring the possibility for strategic expansion into other areas where we might see near-term milestones and results. We look forward to continuing to update our stockholders on these opportunities as they develop.”

• • 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.”