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S&P 500 Treats Investors To A New Record High On Thursday- $FATE $INVO $INMB $ORPH Move Higher!

By John F. Heerdink, Jr.
“We must shift our thinking away from short-term gain toward long-term investment and sustainability, and always have the next generations in mind with every decision we make.” –  Deb Haaland


Happy Day Before Friday All!

I hope you had a great market session on Thursday and managed to create a bit more wealth for you and yours.

The broad markets were generally in our corner today as the S&P 500 achieved a new all-time record closing 4,239.18 (+.47%). The Dow 30 ticked higher and closed at 34,466.24 (+.06%) with Dow 30 component & tech giant Apple (AAPL) closing at $126.11, down .8%. The Nasdaq closed strongly at 14,020.33 (+.78%), however, the Russell 2000 closed at 2,311.41 (-.68%). The iShares Micro-Cap ETF (IWC) pulled back for the 2nd day in a row to close at $153.31, -2.04%, but did manage to hit an intraday high of $156.09.

The yield curve flattened today as the 10-yr treasury yield closed down another 3 basis points to end at 1.46% & the 2-yr yield closed up 1 basis point at .15%. The U.S. Dollar Index stayed above 90 closing at 90.06.  The macroeconomic schedule produced the total CPI which confirmed a rise by .6% m/m in May & Core CPI moved up by .7% while on a Y-O-Y basis, total CPI is up 5%. The Initial claims report for the week ending June 5 confirm a 9k to 375k, while continuing claims for the week ending May 29 dropped 258k to 3.499M. The Treasury Budget for May confirmed a $131.9B deficit. Tomorrow, the schedule will produce the  preliminary University of Michigan Index of Consumer Sentiment for June.

BIOTECH

The biotech sector continued to moved a higher again for the 4th day this week. The SPDR S&P Biotech ETF (XBI) closed at $136.09, +1.02% after hitting a intraday high of $136.43, but well off from its 52-week high $174.79 & above the 52-week low of $97.15. The iShares Nasdaq Biotechnology ETF (IBB) also closed at $163.20, +1.69% & the NYSE ARCA Biotech Index (^BTK) closed at 6,022.37, +2.37%.

ENERGY & EV

Oil prices moved higher by .6% today closing at $70.30/bbl. Dow 30 component Chevron (CV) closed at $108.41, +.58%. EV manufacturing giant Tesla (TSLA) stalled to close back over $600 at $610.12, +1.89%, while shares of Ford Motor Co (F) also edged lower again after its recent jump closing at $15.11, -2.39% & recently hitting a new 52-high of $16.45. Over the last week Ford confirmed that Ford SUVs posted their best May Retail Sales Since 2003 & that they achieved a record SUV Sales for Lincoln on Gains From Entire Lineup.

TECH & CONSUMER DISCRETIONARY

The FAANG’s ended higher except for Apple as follows: Apple (AAPL) closed at $126.11, -.8%, Amazon (AMZN, $3,349.65, +2.09%), Alphabet (GOOG) closed at $2,521.60, +1.21%, Facebook (FB) closed at $332.46, +.67% & Netflix (NFLX) closed at $487.271/share, +.30%. The MicroSectors FANG+ Index 3X Leveraged ETN (FNGU), which offers 3x leveraged exposure to an index of “FANG” companies, and other companies that exhibit similar characteristics, closed at $29.74, -.87%. 

The Technology Select Sector SPDR Fund (XLK) closed at $141.13, +.74%. Chip maker NVIDIA (NVDA) established a new-all time high of $712.50 on Monday, but closed at $697, +.38% today. Tech giant Microsoft (MSFT) closed at $257.24, +1.44%. Famous tech and biotech investor Cathie Wood’s ARK Innovation ETF (ARKK) closed at 114.97, +1.88% & substantially off from its 52-wk high of $159.70. ARKK is an actively-managed exchange-traded fund (“ETF”) that will invest under normal circumstances primarily (at least 65% of its assets) in domestic and foreign equity securities of companies that are relevant to the fund’s investment theme of disruptive innovation. Its investments in foreign equity securities will be in both developed and emerging markets. It may invest in foreign securities (including investments in American Depositary Receipts (“ADRs”) and Global Depositary Receipts (“GDRs”)) and securities listed on local foreign exchanges. The fund is non-diversified.

ADT (ADT), the “most trusted brand in smart home and small business security” and Google partner moved higher today closing at $11.52, -.09% after touching $11.78 in intraday trading. Its 52-wk high is $17.21 and it has been trending up from the low $9 level since we entered the stock on May 4th prior to their Q1 2021 results were released on the morning of May 5th. On August 3, 2020, ADT and Google announced a partnership to create ‘Leading Smart Home Security Offering’. The partnership has allowed Google’s award-winning Nest hardware to be combined with ADT’s trusted security, professional installation and monitoring service to create a fully integrated set of devices, software and services for the secure smart home & pairs ADT’s more than 20,000 professionals together with Google’s suite of helpful home hardware, manufacturing technology and vertical technology stack. Google also invested $450 million to acquire 6.6% ownership in ADT, cementing mutual, long-term commitment to partnership. Each company is to commit $150 million for co-marketing, product development, technology and employee training. This partnership is believed to provide customers with integrated smart home technology to be offered in both DIY and professionally installed security offerings.

SILVER & GOLD

As for precious metals, silver closed at $28.12/oz, +$.19 & gold closed at $1901, +$9. The iShares Silver Trust ETF (SLV) closed at $25.97, +.74% & the SPDR Gold Shares (GLD) closed at $177.74, +.43%. North American silver and gold producer Hecla Mining (HL) closed at $9.28, +4.39% after recently establishing a new 52-week high of $9.44. Recently, Hecla Mining Company (NYSE:HL) released its Q1 2021 exploration results. Phillips S. Baker, Jr., President and CEO stated, “Our early exploration results, just two miles from the mine portal, validates our thesis that despite its long high-grade production history, there remains significant untouched potential at Midas. The recent high-grade intercept grading 5.52 oz/ton gold and 8.9 oz/ton silver over 20.3 feet drilled (13.1 feet estimated true width) is one of the best exploration drill holes in North America in the past year. But maybe more important than the grade and width of the discovery are the two additional mineralized structures in the footwall of the main structure and that significant mineralization continues over a strike of 1,000 feet and a dip length of 1,250 feet. All structures are open along strike and at depth.”

MEMES REPORT TAKE IT ON THE CHIN

MemeStock, AMC Entertainment (AMC), closed at $42.81, backing off -13.23%. Last week, AMC announced that it has completed another 11.550M share at-the-market (“ATM”) equity program. AMC raised approximately $587.4M of new equity capital, before commissions and fees, at an average price of approximately $50.85 per share. AMC President and CEO Adam Aron said, “Bringing in an additional $587.4 million of new equity on top of the $658.5 million already raised this quarter results in a total equity raise in the second quarter of $1.246 billion, substantially strengthening and improving AMC’s balance sheet, providing valuable flexibility to respond to potential challenges and capitalize on attractive opportunities in the future.” Earlier this week AMC announced that it had entered into an agreement to raise $230.5 million of cash from the sale of equity to Mudrick Capital Management, L.P. in exchange for 8.5 million shares of AMC’s Class A Common stock. The equity was raised at a price of approximately $27.12 per share.  

GameStop (GME) also closed at $220.39, -27.16%. Yesterday, GME announced that it has appointed Matt Furlong as Chief Executive Officer and Mike Recupero as Chief Financial Officer. Mr. Furlong and Mr. Recupero join from Amazon, where they each held senior roles and oversaw various growth initiatives during their respective tenures. Mr. Furlong’s start date is June 21, 2021 and Mr. Recupero’s start date is July 12, 2021. Yesterday, GME also reported results for the first quarter ended May 1, 2021. First Quarter Fiscal 2021 Highlights included Net sales that increased 25.1% to $1.277 billion, compared to $1.021 billion in the fiscal 2020 first quarter, overcoming a nearly 12% reduction in the Company’s global store base due to strategic de-densification efforts, and continued store closures across Europe due to the COVID-19 pandemic; Gross margin was 25.9%, a decline of 180 basis points compared to the fiscal 2020 first quarter; & Adjusted EBITDA of ($0.7) million compared to ($75.5) million in the fiscal 2020 first quarter.

Bed Bath & Beyond (BBBY) closed at $31.53, backing off -8.05%. This week, BBBT announced the launch of Our Table™, a new collection of modern kitchen and dinnerware designed to help every home cook share more great meals together. Available only at Bed Bath & Beyond, Our Table features a modern and durable assortment of cookware, bakeware, dinnerware, table linens, kitchen tools, kitchen linens and more. The launch of Our Table celebrates an exciting time where many customers are preparing to welcome guests back into their homes, share recipes, and gather together at the same table.

BlackBerry Limited (BB) closed at $13.89, -8.38% after hitting $15.24 in intraday trading.  BB recently announced that BlackBerry® Optics 3.0, its next-generation cloud-based endpoint detection and response (EDR) solution and BlackBerry® Gateway, the company’s first AI-empowered Zero Trust Network Access (ZTNA) product. Rooted in a prevention-first and AI-driven approach, BlackBerry’s new endpoint and network security capabilities will help differentiate BlackBerry’s extended detection and response (XDR) strategy.

Clover Health Investments, Corp. (CLOV), which operates as a Medicare Advantage insurer in the United States, closed $14.34, -15.25after this week’s whopping one-day +85.82% gain. On May 17, CLOV reported financial results for the first quarter of 2021 highlighting “Record Revenue of Over $200 million” & “Lives Under Management Nearly Doubles Following The Launch of Direct Contracting.” Clover Health CEO Vivek Garipalli stated, “Clover’s mission is to use our technology platform to improve every life, and every day that passes brings us one step closer to that goal. I am excited that we have reached our strategic milestone of moving beyond Medicare Advantage into the largest segment of Medicare – Original Medicare – by launching Direct Contracting. This has led to our lives under management nearly doubling to over 130,000 Americans.”

Wendy’s (WEN) cooled off and closed at $24.421, -3.13%. Wendy’s was founded in 1969 by Dave Thomas in Columbus, Ohio. Dave built his business on the premise, “Quality is our Recipe®,” which remains the guidepost of the Wendy’s system. Wendy’s is best known for its made-to-order square hamburgers, using fresh, never frozen beef****, freshly-prepared salads, and other signature items like chili, baked potatoes and the Frosty® dessert. The Wendy’s Company (Nasdaq: WEN) is committed to doing the right thing and making a positive difference in the lives of others. 

The Geo Group, Inc. (GEO), a fully integrated equity real estate investment trust specializing in the design, financing, development, and operation of secure facilities, processing centers, and community reentry centers in the United States, Australia, South Africa, and the United Kingdom, closed at $7.05, down 19,89% after yesterday’s +38.36% romp. On June 1, GEO announced that its Chairman, Chief Executive Officer and Founder, George C. Zoley, is transitioning to the position of Executive Chairman of GEO’s Board of Directors under a new five-year employment agreement with subsequent automatic one-year renewals, and Jose Gordo will be appointed Chief Executive Officer effective July 1, 2021, reporting to Mr. Zoley.

Clean Energy Fuels Corp. (CLNE) closed at $110.99, down 15-59% after yesterday’s +31.52% jump. CLNE is the country’s leading provider of the cleanest fuel for the transportation market. Through its sales of renewable natural gas (RNG), which is derived from biogenic methane produced by the breakdown of organic waste, Clean Energy enables thousands of vehicles, from airport shuttles to city buses to waste and heavy-duty trucks, to reduce their amount of climate-harming greenhouse gas by 60% to over 400% depending on the source of the RNG, according to the California Air Resources Board.


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 $17.14, +9.31% after touching $17.29 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.
  • 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 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) continued to trend higher and closed at $88.42/share, +6.7%. The 52-wk high is $121.16. 

    • 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 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 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 $4.75/share, +7.22%. 
  • Could we be setting up for another March 9, 2021 type of run for INVO shares where +96M shares traded for this low-float stock (~10.4M shares are issued and outstanding). The stock shot up to a new 52-week high of $12.30 that day. The stock has now continued to trend overall positively since May 11th.  See INVO’s chart here. 
    • 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 $17.10, -2.62%. 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 $4.07, -7.5%.
  • 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. 
    • This week, Physician-Scientist Dr. Steven C. Quay, M.D., Ph.D., CEO of Atossa Therapeutics (NASDAQ: ATOS) was asked to brief the elected members and staff of the United States Congress on his work on the origin of the COVID-19 pandemic. The virtual meeting was scheduled for Monday, May 24, 2021. Dr. Quay was too speak about his research on the origin of the pandemic, which he published in January 2021 and which is available here. In this analysis he concludes that it is beyond a reasonable doubt the virus came from a laboratory accident, a so called “laboratory-acquired infection”, in Wuhan, China. The briefing was also to include a discussion by David Asher, a senior fellow at the Hudson Institute, about his work at the U.S. State Department looking into the origins of COVID-19 and the role of the Chinese government. Dr. Quay recently stated, “While it would be a positive step for China to be open and transparent with records from the Wuhan Institute of Virology that were not shared with the WHO Committee during their field work in China earlier this year, there already exists more than enough data and evidence to conclude with high certainty that the COVID pandemic did not arise from a natural zoonosis. The purpose of this briefing is to supply relevant congressional staff and members with the facts that are not in dispute with respect to the pandemic, to show how these facts are different from any prior zoonosis, to show these facts are completely consistent with a lab-leak, and finally, to document the genetic signatures that are consistent with ‘gain-of-function’ laboratory manipulation. For over a year there has been a reticence to consider a lab-leak as the source of this pandemic despite the fact that most of the evidence I will present has been in the public domain all this time. It is clear to me that only a grass roots effort directed to the federal government will bring the urgency to help uncover the cause of the pandemic and set the stage to put in place the safeguards to prevent the next. You can help in this fight by inviting your Representative and Senators to this briefing on the leading COVID origin hypothesis, the possibility of a laboratory acquired infection at the Wuhan Institute of Virology. We owe it to the three million people who have died to get to the bottom of this.”

    • 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.”
  •  


Economic Reports

  • On Monday, the macroeconomic schedule produced the Consumer Credit report for April that confirmed an $18.6B rise.
  • On Tuesday, the trade deficit report confirmed that it narrowed in April to $68.9B,  while April exports moved up $2.3B &  April imports came in $3.8B lower. Per the JOLTS report Job openings were confirmed at a record 9.286M in April. The NFIB Small Business Optimism Index report for May showed a drop to 99.6.
  • On Wednesday, the Wholesale inventories report confirmed a rise by .8% month/month in April. The weekly MBA Mortgage Applications Index report confirmed a drop by 3.1%.
  • On Thursday, the total CPI confirmed a rise by .6% m/m in May & Core CPI moved up by .7% while on a Y-O-Y basis, total CPI is up 5%. The Initial claims report for the week ending June 5 confirm a 9k to 375k, while continuing claims for the week ending May 29 dropped 258k to 3.499M. The Treasury Budget for May confirmed a $131.9B deficit.

Investing & Inspiration

  1. “We must shift our thinking away from short-term gain toward long-term investment and sustainability, and always have the next generations in mind with every decision we make.” –  Deb Haaland
  2. “The only way to have a friend is to be one.” –  Ralph Waldo Emerson
  3. “If you believe in yourself and have dedication and pride – and never quit, you’ll be a winner. The price of victory is high but so are the rewards.” – Bear Bryant
  4. “Investing in women’s lives is an investment in sustainable development, in human rights, in future generations – and consequently in our own long-term national interests.” -Liya Kebede

  5. “Success is not final, failure is not fatal: it is the courage to continue that counts.”– Winston Churchill
  6. “Our greatest glory is not in never falling, but in rising every time we fall.” – Confucius

  7. “Give me a lever long enough and a fulcrum on which to place it, and I shall move the world.” – Archimedes
  8. “Who controls the past controls the future. Who controls the present controls the past.” – George Orwell
  9. “If you get up in the morning and think the future is going to be better, it is a bright day. Otherwise, it’s not.” – Elon Musk
  10. “The pessimist complains about the wind; the optimist expects it to change; the realist adjusts the sails.” – William Arthur Ward
  11. “Start where you are. Use what you have. Do what you can.” – Arthur Ashe
  12. “Netflix, Amazon, iTunes – whatever platforms emerge – we are looking at as having the same potential that home video had for the movie business. Which means there are entirely new opportunities to monetize our capital investment in content and do so in ways that work for distributors, for consumers and for creators.” – Bob Iger
  13. “When you have no one to answer to, vendetta as investment strategy is as legitimate as anything.” – Carl Icahn

  14. “No other investment yields as great a return as the investment in education. An educated workforce is the foundation of every community and the future of every economy.” – Brad Henry
  15. “In my view, the biggest investment risk is not the volatility of prices, but whether you will suffer a permanent loss of capital. Not only is the mere drop in stock prices not risk, but it is an opportunity. Where else do you look for cheap stocks?” – Li Lu
  16. “Modern medical advances have helped millions of people live longer, healthier lives.

  17. We owe these improvements to decades of investment in medical research.”– Ike Skelton

  18. “Stock market goes up or down, and you can’t adjust your portfolio based on the whims of the market, so you have to have a strategy in a position and stay true to that strategy and not pay attention to noise that could surround any particular investment.” – John Paulson

  19. “Your mindset matters. It affects everything – from the business and investment decisions you make, to the way you raise your children, to your stress levels and overall well-being.” – Peter Diamandis
  20. “Inflation destroys savings, impedes planning, and discourages investment. That means less productivity and a lower standard of living.” – Kevin Brady
  21. “Bitcoin, in the short or even long term, may turn out be a good investment in the same way that anything that is rare can be considered valuable. Like baseball cards. Or a Picasso.” – Andrew Ross Sorkin
  22. “I think you have to learn that there’s a company behind every stock and there’s only one real reason why stocks go up. Companies go from doing poorly to doing well or small companies grow to large companies.” – Peter Lynch
  23. “Historically, there has been a bull market in the commodities every 20 or 30 years.” – Jim Rogers
  24. “The markets generally are unpredictable, so that one has to have different scenarios. The idea that you can actually predict what’s going to happen contradicts my way of looking at the market.” – George Soros
  25. “Stop trying to predict the direction of the stock market, the economy or the elections.” – Warren Buffett
  26. “An important key to investing is to remember that stocks are not lottery tickets.” – Peter Lynch
  27. “Learn everyday, but especially from the experiences of others. It’s cheaper!” – John Bogle
  28. “When purchasing depressed stock in troubled companies, seek out the ones with the superior financial positions and avoid the ones with loads of bank debt.” – Peter Lynch
  29. “No stock price is too low for bears or too high for bulls.” – John F. Heerdink, Jr.
  30. “Investment is most successful when it is most businesslike.” – Ben Graham

  31. “Value stocks are about as exciting as watching grass grow, but have you ever noticed just how much your grass grows in a week?” – Christopher Browne

  32. “Even the intelligent investor is likely to need considerable willpower to keep from following the crowd.” – Benjamin Graham
  33. “Individual who cannot master their emotions are ill-suited to profit from the investment process.” – Benjamin Graham
  34. “I made my first investment at age eleven. I was wasting my life until then.” – Warren Buffet
  35. “I don’t look to jump over seven-foot bars; I look around for one-foot bars that I can step over.” — Warren Buffett
  36. “There are only three measurements that tell you nearly everything you need to know about your organization’s overall performance: employee engagement, customer satisfaction, and cash flow. It goes without saying that no company, small or large, can win over the long run without energized employees who believe in the mission and understand how to achieve it.” – Jack Welch, former CEO of GE
  37. “Opportunities come infrequently. When it rains gold, put out the bucket, not the thimble” ― Warren Buffett
  38. “If you buy things you do not need, soon you will have to sell things you need.” – Warren Buffet
  39. “How many millionaires do you know who have become wealthy by investing in savings accounts? I rest my case.” — Robert G. Allen
  40. “It’s far better to buy a wonderful company at a fair price, than a fair company at a wonderful price.” – Warren Buffett
  41. “A market downturn doesn’t bother us. It is an opportunity to increase our ownership of great companies with great management at good prices.” — Warren Buffett
  42. “Every once in a while, the market does something so stupid it takes your breath away.” — Jim Cramer
  43. “The person who starts simply with the idea of getting rich won’t succeed; you must have a larger ambition.” — John D. Rockefeller
  44. “Know what you own, and know why you own it.” – Peter Lynch
  45. “Although it’s easy to forget sometimes, a share is not a lottery ticket… it’s part ownership of a business.” – Peter Lynch
  46. “Wise spending is part of wise investing. And it’s never too late to start.” – Rhonda Katz
  47. “Invest for the long haul. Don’t get too greedy and don’t get too scared.” – Shelby M.C. Davis

  48. “Fear incites human action far more urgently than does the impressive weight of historical evidence.”
    -Jeremy Siegel
  49. “With a good perspective on history, we can have a better understanding of the past and present, and thus a clear vision of the future.” — Carlos Slim Helu
  50. “If we like a business, we’re going to buy as much of it as we can and keep it as long as we can. And when we change our mind, we don’t take half measures.” – Warren Buffett
  51. “The most contrarian thing of all is not to oppose the crowd but to think for yourself.” — Peter Thiel

  52. “Never depend on a single income, make an investment to create a second source.” Warren Buffet

  53. Games are won by players who focus on the playing field –- not by those whose eyes are glued to the scoreboard.”
    ― Warren Buffett
  54. “The key to making money in stocks is not to get scared out of them.” – Peter Lynch
  55. “Courage taught me no matter how bad a crisis gets … any sound investment will eventually pay off.” — Carlos Slim Helu
  56. “Investing puts money to work. The only reason to save money is to invest it.” – Grant Cardone
  57. “As time goes on, I get more and more convinced that the right method of investment is to put fairly large sums into enterprises which one thinks one knows something about and in the management of which one thoroughly believes.” — John Maynard Keynes
  58. “Given a 10% chance of a 100 times payoff, you should take that bet every time.” — Jeff Bezos
  59. “Money is always eager and ready to work for anyone who is ready to employ it.” ― Idowu Koyenikan
  60. The secret to investing is to figure out the value of something – and then pay a lot less.” – Joel Greenblatt
  61. “We don’t have an analytical advantage, we just look in the right place.” – Seth Klarman
  62. “Men, it has been well said, think in herds. It will be seen that they go mad in herds, while they only recover their senses slowly, and one by one.” – Charles Mackay
  63. “It’s not whether you’re right or wrong that’s important, but how much money you make when you’re right and how much you lose when you’re wrong.” – George Soros
  64. “No Price is too low for a bear or too high for a bull.” — Anonymous
  65. “Investment is an asset or item that is purchased with the hope that it will generate income or appreciate in the future.” Anonymous
  66. “Behind every stock is a company. Find out what it’s doing.” — Peter Lynch
  67. “Wise spending is part of wise investing. And it’s never too late to start.” –Rhonda Katz
  68. “It amazes me how people are often more willing to act based on little or no data than to use data that is a challenge to assemble.” ― Robert Shiller
  69. “A bull market is like sex. It feels best just before it ends.” — Barton Biggs
  70. “The investor’s chief problem — even his worst enemy — is likely to be himself.” — Benjamin Graham
  71. “No profession requires more hard work, intelligence, patience, and mental discipline than successful speculation.” – Robert Rhea
  72. “Money is like a sixth sense – and you can’t make use of the other five without it.” – William Somerset Maugham
  73. “Compound interest is the eighth wonder of the world. He who understands it, earns it. He who doesn’t, pays it.” — Albert Einstein
  74. “Never count on making a good sale. Have the purchase price be so attractive that even a mediocre sale gives good results” — Warren Buffett
  75. “The stock market is a device for transferring money from the impatient to the patient.” – Warren Buffett
  76. “Thousands of experts study overbought indicators, head-and-shoulder patterns, put-call ratios, the Fed’s policy on money supply…and they can’t predict markets with any useful consistency, any more than the gizzard squeezers could tell the Roman emperors when the Huns would attack.” – Peter Lynch
  77. “Investing puts money to work. The only reason to save money is to invest it.” – Grant Cardone
  78. “You cannot save time for your future use however you can invest time for your future.” – John F. Heerdink, Jr. 
  79. “Know what you own, and know why you own it.” – Peter Lynch
  80. “Liquidity is only there when you don’t need it.” -Old Proverb
  81. “If you want to be a millionaire, start with a billion dollars and launch a new airline.” – Richard Branson
  82. “Fear incites human action far more urgently than does the impressive weight of historical evidence.” – Jeremy Siegel
  83. “In investing, what is comfortable is rarely profitable.” – Robert Arnott
  84. “Spend each day trying to be a little wiser than you were when you woke up.” – Charlie Munger
  85. “The entrance strategy is actually more important than the exit strategy.” – Edward Lampert
  86. “The rivers don’t drink their own water; Trees don’t eat their own fruits. The sun does not shine for itself, And flowers do not spread their fragrance For themselves. Living for others is a rule of nature” – Pope Francis
  87. “It is impossible to produce superior performance unless you do something different from the majority.” – John Templeton
  88. “An investment in knowledge pays the best interest.” – Benjamin Franklin.
  89. I believe the returns on investment in the poor are just as exciting as successes achieved in the business arena, and they are even more meaningful!” -Bill Gates
  90. “Every portfolio benefits from bonds; they provide a cushion when the stock market hits a rough patch. But avoiding stocks completely could mean your investment won’t grow any faster than the rate of inflation.” – Suze Orman
  91. “The tax on capital gains directly affects investment decisions, the mobility, and flow of risk capital… the ease or difficulty experienced by new ventures in obtaining capital, and thereby the strength and potential for growth in the economy.” – John F. Kennedy
  92. “If all the economists were laid end to end, they’d never reach a conclusion. -George Bernard Shaw
  93. “There are old traders and there are bold traders, but there are very few old, bold traders.”-Ed Seykota
  94. “Let this scenario play out on its own, in its own fashion. As you watch it unfold, you will soon be grateful that you choose the peaceful path. Remember — those who live by the sword, die by the sword.”
  95. “As long as you enjoy investing, you’ll be willing to do the homework and stay in the game.” -Jim Cramer
  96. “I rarely think the market is right. I believe non-dividend stocks aren’t much more than baseball cards. They are worth what you can convince someone to pay for it.” -Mark Cuban
  97. Michael Marcus taught me one other thing that is absolutely critical: You have to be willing to make mistakes regularly; there is nothing wrong with it. Michael taught me about making your best judgment, being wrong, making your next best judgment, being wrong, making your third best judgment, and then doubling your money.” -Bruce Kovner
  98. “The policy of being too cautious is the greatest risk of all.” -Jawaharlal Nehru
  99. “The only true test of whether a stock is “cheap” or “high” is not its current price in relation to some former price, no matter how accustomed we may have become to that former price, but whether the company’s fundamentals are significantly more or less favorable than the current financial-community appraisal of that stock.” -Philip Fisher
  100. “I learned to avoid trying to catch up or double up to recoup losses. I also learned that a certain amount of loss will affect your judgment, so you have to put some time between that loss and the next trade.” -Richard Dennis
  101. “The four most dangerous words in investing are: ‘this time it’s different.” -Sir John Templeton
  102. “Money doesn’t make you happy. I now have $50 million but I was just as happy when I had $48 million.” -Arnold Schwarzenegger

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