Monday’s Markets See Record Setting Start For Nasdaq & S&P 500 – $FB $FATE $MRIN $NTLA $NVDA Jump
- Published Jun 28, 2021
- Apple
- Current Coverage
- Fate Therapeutics, Inc.
- Market News
Happy Monday!
I hope that you had a great start to the week in the markets.
Today’s session saw records broken on both the Nasdaq & the S&P 500. The moves were led by the highly weighted information technology sector that rose strongly by 1.1%, while Apple (AAPL) closed at $134.78, +1.25%. At the same time, the cyclicals, which led last week’s strong swing, fell as the energy sector dropped by 3.3%, the financials pulled back .8%, & the industrials moved down by .5%. The Dow 30 and Russell moved lower. reviewing the end of day results, the S&P 500 closed at a new report high of 4,290.61 (+.23%), the Dow 30 closed at 34,283.27 (-.44%), the Nasdaq achieved another new record high and closed at 14,500.51 (+.98%), while the Russell 200o closes at 2,322.34 (-.52%). The microchips also moved lower as evidenced by the iShares Micro-Cap ETF (IWC) closed at $153.83, -1.12%, but not to far off of its 52-wk high of $159.56.
The yield curve moved lower today as the 10-yr treasury yield pulled back 7 basis points to close at 1.47% & the 2-yr yield moved lower by 2 basis points to .25%. The U.S. Dollar Index edged higher to end at 91.90.
On a somber note, stories regarding the spreading of the delta coronavirus variant and the subsequent resurgence of travel restrictions is being seen in several countries, which is placing greater concern on global growth. This news reportedly came out of Australia, South Africa, Germany, Portugal, Russia, and also interestingly in Bangladesh where the Bangladesh’s government has halted all public transportation. Oil prices moved lower by 1.5% to $72.82/bbl.
The macroeconomic schedule was quiet today, but tomorrow we will see the Conference Board’s Consumer Confidence Index report for June, the FHFA Housing Price Index report for April, & the S&P Case-Shiller Home Price Index report for April
BIOTECH & HEALTHCARE DRIFTS – NTLA POPS
The SPDR S&P Biotech ETF (XBI) closed at $137.85, -.60% after hitting a intraday high of $141.04 and a low of $135.12, & well off from its 52-week high $174.79 & above the 52-week low of $97.15. The iShares Nasdaq Biotechnology ETF (IBB) closed at $163.37, +.15% & the NYSE ARCA Biotech Index (^BTK) closed at 5,920.70, +.57%.
Today, Intellia Therapeutics, Inc. (NASDAQ: NTLA) closed trading at $133.43, +50.21%. On Saturday June 26, Intellia Therapeutics, Inc. and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN, $542.70, -1.43%) announced positive interim data from an ongoing Phase 1 clinical study of their lead in vivo genome editing candidate, NTLA-2001, which is being developed as a single-dose treatment for transthyretin (ATTR) amyloidosis. The Phase 1 study, run by Intellia as the program’s development and commercialization lead, is evaluating NTLA-2001 in people living with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN). NTLA-2001 is the first CRISPR/Cas9-based therapy candidate to be administered systemically, via intravenous infusion, for precision editing of a gene in a target tissue in humans. NTLA-2001 is designed to inactivate the TTR gene in liver cells to prevent the production of misfolded transthyretin (TTR) protein, which accumulates in tissues throughout the body and causes the debilitating and often fatal complications of ATTR amyloidosis. The interim data were presented today at the 2021 Peripheral Nerve Society (PNS) Annual Meeting and published in The New England Journal of Medicine. “These are the first ever clinical data suggesting that we can precisely edit target cells within the body to treat genetic disease with a single intravenous infusion of CRISPR. The interim results support our belief that NTLA-2001 has the potential to halt and reverse the devastating complications of ATTR amyloidosis with a single dose,” said Intellia President and Chief Executive Officer John Leonard, M.D.
MEMES REPORT
AMC Entertainment (AMC) closed at $58.11, +7.49% after hitting $59.36 in intraday trading.
GameStop (GME) also closed at $213.25, +1.79%.
1847 Goedeker Inc. (GOED) closed at $4.19, -2.33% after reaching $4.48 in intraday trading. “Goedekers” the largest pure-play online retailer of household appliances in the US, recently reported continued strong growth with record revenue for the month of May 2021, up 41.9% from May 2020 to $44.3 million on May 2021 written orders of $72.6 million.
Today Marin Software (MRIN) skyrocketed to close at $7.50, +96.85% and has even hit an aftermarket high of $10.50 on over 287M shares of trading! MRIN is a leading provider of digital marketing software for performance-driven advertisers and agencies who announced on June 23 that they had added the ability to manage Instacart Ads to its flagship MarinOne platform. This integration is reported to “make it easier for brands to connect with customers directly at the point of sale.”
TESLA
Tesla (TSLA) had another good day closing at $688.72, +2.51% as it has been on uptrend over the last two weeks.
FACEBOOK WINS
Facebook (FB) closed at $355.64, +4.2% closing at a $1.02T market cap. The upward swing came after a judge from the U.S. district court dismissed the FTC’s antitrust lawsuit against the company stating “the FTC has failed to plead enough facts to plausibly establish … that Facebook has monopoly power in the market for Personal Social Networking (PSN) Services.”
NVDA MOVES HIGHER
NVIDIA (NVDA) closed at $799.40, +5% today after establishing a new all-time high of $893.73 now standing at a $498.03B market cap. if off some reason you do not who NVDA is yet, note that they are a Santa Clara, California based NVIDIA Corporation that operates as a visual computing company worldwide. It operates in two segments, Graphics and Compute & Networking. The Graphics segment offers GeForce GPUs for gaming and PCs, the GeForce NOW game streaming service and related infrastructure, and solutions for gaming platforms; Quadro/NVIDIA RTX GPUs for enterprise design; GRID software for cloud-based visual and virtual computing; and automotive platforms for infotainment systems. The Compute & Networking segment offers Data Center platforms and systems for AI, HPC, and accelerated computing; Mellanox networking and interconnect solutions; automotive AI Cockpit, autonomous driving development agreements, and autonomous vehicle solutions; and Jetson for robotics and other embedded platforms. The company’s products are used in gaming, professional visualization, datacenter, and automotive markets. NVIDIA Corporation sells its products to original equipment manufacturers, original device manufacturers, system builders, add-in board manufacturers, retailers/distributors, Internet and cloud service providers, automotive manufacturers and tier-1 automotive suppliers, mapping companies, start-ups, and other ecosystem participants.
MRIN SKYROCKETS
Today Marin Software (MRIN) , a leading provider of digital marketing software for performance-driven advertisers and agencies, has added the ability to manage Instacart Ads to its flagship MarinOne platform. This integration makes it easier for brands to connect with customers directly at the point of sale.
VP WATCHLIST HIGHLIGHTS
Our complete VP Watchlist is a list that we believe deserves consideration for short term and long term portfolio adds that include Apple, Tesla, & seven other names current. The dedicated pages for each of these companies 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 $18.74, -1.68% after touching $19.49 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.
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On June 14th, INMB announced that it had 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.
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- 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.
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- 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.
- 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.
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- On June 2nd, the United States Adopted Name Council (USAN) has adopted the name “Pegipanermin” for INMB’s lead clinical candidate, XPro1595.
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- 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.
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- 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.
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- 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 $89.12/share, +5.41%. The 52-wk high is $121.16.
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- On 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.
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- 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.
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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.
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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.”
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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.
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- 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 $4.98, -.4%.
- On June 15th, 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.
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- 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.”
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- 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.
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- 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.
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- 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 $15.21, -2.44%. 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.
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- 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.
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- 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.”
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- 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.”
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- 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.
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- 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.”
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- 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.
- Shares of VP Watchlist firm, 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 $8.25, after recently hitting a new all-time 52-wk high of $9.80 in intraday trading and now currently sports a $996.80M market cap.
- Atossa was recently added to the Russell 2000 and Russell 3000 Indexes.
- 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.
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- 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.
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- 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.
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- 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.
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- 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.
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- 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.”
- InMed Pharmaceuticals, Inc. (NASDAQ: INM) is leading clinical-stage pharmaceutical company developing cannabinoid-based drug candidates for high unmet medical needs and IntegraSyn, a proprietary and cost effective manufacturing approach for synthesized rare cannabinoids.
- Shares of InMed closed at closed trading at $2.96, +3.5%. The 52-wk range is $2.55 -$8.94.
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- On Thursday, June 17th, InMed Pharmaceuticals (NASDAQ: INM) announced that its continued optimization of IntegraSyn™ has increased the cannabinoid yield to a level of 5 g/L, further improving the economics of this proprietary manufacturing approach in advance of large-scale production. InMed’s cannabinoid yield of 5 g/L significantly exceeds currently reported industry yields. The Company has continued to make important steps to further optimize the IntegraSyn™ manufacturing process, resulting in the improved yield of 5 g/L, surpassing InMed’s previously reported yield levels of 2 g/L, an already commercially viable yield. The impact of improved yield is a significant reduction in the overall cost of manufacturing due to greater amount of cannabinoid produced per batch. InMed is now focused on manufacturing scale-up to larger batch sizes in the second half of calendar year 2021. “We are very excited by these impressive yield levels that further validates the IntegraSyn™ manufacturing approach as a commercially viable solution for large-scale, pharmaceutical-grade GMP production of rare cannabinoids. While we continue to refine the process, we are now focused on advancing the program towards the next key milestones, including the manufacture of our first large-scale batch through a GMP-ready process in the coming months. We continue to believe InMed’s proprietary IntegraSyn™ approach will be one of the most important manufacturing processes for pharma-grade cannabinoids,” stated Eric A. Adams, President and Chief Executive Officer of InMed.
- Learn more about INM’s IntegraSyn, a proprietary and cost effective manufacturing approach for synthesized rare cannabinoids, by viewing the following short video.
Economic Reports
- On Monday, the macroeconomic schedule did not produce any siginificant reports today.
Investing & Inspiration
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“View health as an investment, not an expense.” – John Quelch
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“Opportunity does not knock, it presents itself when you beat down the door.” – Kyle Chandler
- “If you don’t know where you are going, any road will get you there.” – Lewis Carroll
- “Once you replace negative thoughts with positive ones, you’ll start having positive results.” – Willie Nelson
- “That which does not kill us makes us stronger.” – Friedrich Nietzsche
- “Nothing in life is to be feared, it is only to be understood. Now is the time to understand more, so that we may fear less.” – Marie Curie
- “A problem is a chance for you to do your best.”– Duke Ellington
- “The best way to predict the future is to create it.” -Peter Drucker
- “I’m involved in the stock market, which is fun and, sometimes, very painful.” – Regis Philbin
- “Who owns the future? This is the question at the heart of every stock market.” – John Landgraf
- “One of the funny things about the stock market is that every time one person buys, another sells, and both think they are astute.” – William Feather
- “While I’m sure some millennials are concerned with the ethical issues involved in mining for diamonds, the main reason they steer clear of the gems is because, well, they’re a dumb investment.” – Ana Kasparian
- “The wisest rule in investment is: when others are selling, buy. When others are buying, sell. Usually, of course, we do the opposite. When everyone else is buying, we assume they know something we don’t, so we buy. Then people start selling, panic sets in, and we sell too.” – Jonathan Sack
- “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
- “The only way to have a friend is to be one.” – Ralph Waldo Emerson
- “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
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“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
- “Success is not final, failure is not fatal: it is the courage to continue that counts.”– Winston Churchill
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“Our greatest glory is not in never falling, but in rising every time we fall.” – Confucius
- “Give me a lever long enough and a fulcrum on which to place it, and I shall move the world.” – Archimedes
- “Who controls the past controls the future. Who controls the present controls the past.” – George Orwell
- “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
- “The pessimist complains about the wind; the optimist expects it to change; the realist adjusts the sails.” – William Arthur Ward
- “Start where you are. Use what you have. Do what you can.” – Arthur Ashe
- “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
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“When you have no one to answer to, vendetta as investment strategy is as legitimate as anything.” – Carl Icahn
- “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
- “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
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“Modern medical advances have helped millions of people live longer, healthier lives.
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We owe these improvements to decades of investment in medical research.”– Ike Skelton
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“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
- “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
- “Inflation destroys savings, impedes planning, and discourages investment. That means less productivity and a lower standard of living.” – Kevin Brady
- “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
- “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
- “Historically, there has been a bull market in the commodities every 20 or 30 years.” – Jim Rogers
- “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
- “Stop trying to predict the direction of the stock market, the economy or the elections.” – Warren Buffett
- “An important key to investing is to remember that stocks are not lottery tickets.” – Peter Lynch
- “Learn everyday, but especially from the experiences of others. It’s cheaper!” – John Bogle
- “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
- “No stock price is too low for bears or too high for bulls.” – John F. Heerdink, Jr.
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“Investment is most successful when it is most businesslike.” – Ben Graham
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“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
- “Even the intelligent investor is likely to need considerable willpower to keep from following the crowd.” – Benjamin Graham
- “Individual who cannot master their emotions are ill-suited to profit from the investment process.” – Benjamin Graham
- “I made my first investment at age eleven. I was wasting my life until then.” – Warren Buffet
- “I don’t look to jump over seven-foot bars; I look around for one-foot bars that I can step over.” — Warren Buffett
- “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
- “Opportunities come infrequently. When it rains gold, put out the bucket, not the thimble” ― W
- “If you buy things you do not need, soon you will have to sell things you need.” – Warren Buffet
- “How many millionaires do you know who have become wealthy by investing in savings accounts? I rest my case.” — Robert G. Allen
- “It’s far better to buy a wonderful company at a fair price, than a fair company at a wonderful price.” – Warren Buffett
- “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
- “Every once in a while, the market does something so stupid it takes your breath away.” — Jim Cramer
- “The person who starts simply with the idea of getting rich won’t succeed; you must have a larger ambition.” — John D. Rockefeller
- “Know what you own, and know why you own it.” – Peter Lynch
- “Although it’s easy to forget sometimes, a share is not a lottery ticket… it’s part ownership of a business.” – Peter Lynch
- “Wise spending is part of wise investing. And it’s never too late to start.” – Rhonda Katz
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“Invest for the long haul. Don’t get too greedy and don’t get too scared.” – Shelby M.C. Davis
- “Fear incites human action far more urgently than does the impressive weight of historical evidence.”
-Jeremy Siegel - “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
- “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
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“The most contrarian thing of all is not to oppose the crowd but to think for yourself.” — Peter Thiel
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“Never depend on a single income, make an investment to create a second source.” Warren Buffet
- “Games are won by players who focus on the playing field –- not by those whose eyes are glued to the scoreboard.”
― Warren Buffett - “The key to making money in stocks is not to get scared out of them.” – Peter Lynch
- “Courage taught me no matter how bad a crisis gets … any sound investment will eventually pay off.” — Carlos Slim Helu
- “Investing puts money to work. The only reason to save money is to invest it.” – Grant Cardone
- “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
- “Given a 10% chance of a 100 times payoff, you should take that bet every time.” — Jeff Bezos
- “Money is always eager and ready to work for anyone who is ready to employ it.” ― Idowu Koyenikan
- “The secret to investing is to figure out the value of something – and then pay a lot less.” – Joel Greenblatt
- “We don’t have an analytical advantage, we just look in the right place.” – Seth Klarman
- “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
- “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
- “No Price is too low for a bear or too high for a bull.” — Anonymous
- “Investment is an asset or item that is purchased with the hope that it will generate income or appreciate in the future.” Anonymous
- “Behind every stock is a company. Find out what it’s doing.” — Peter Lynch
- “Wise spending is part of wise investing. And it’s never too late to start.” –Rhonda Katz
- “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
- “A bull market is like sex. It feels best just before it ends.” — Barton Biggs
- “The investor’s chief problem — even his worst enemy — is likely to be himself.” — Benjamin Graham
- “No profession requires more hard work, intelligence, patience, and mental discipline than successful speculation.” – Robert Rhea
- “Money is like a sixth sense – and you can’t make use of the other five without it.” – William Somerset Maugham
- “Compound interest is the eighth wonder of the world. He who understands it, earns it. He who doesn’t, pays it.” — Albert Einstein
- “Never count on making a good sale. Have the purchase price be so attractive that even a mediocre sale gives good results” — Warren Buffett
- “The stock market is a device for transferring money from the impatient to the patient.” – Warren Buffett
- “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
- “Investing puts money to work. The only reason to save money is to invest it.” – Grant Cardone
- “You cannot save time for your future use however you can invest time for your future.” – John F. Heerdink, Jr.
- “Know what you own, and know why you own it.” – Peter Lynch
- “Liquidity is only there when you don’t need it.” -Old Proverb
- “If you want to be a millionaire, start with a billion dollars and launch a new airline.” – Richard Branson
- “Fear incites human action far more urgently than does the impressive weight of historical evidence.” – Jeremy Siegel
- “In investing, what is comfortable is rarely profitable.” – Robert Arnott
- “Spend each day trying to be a little wiser than you were when you woke up.” – Charlie Munger
- “The entrance strategy is actually more important than the exit strategy.” – Edward Lampert
- “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
- “It is impossible to produce superior performance unless you do something different from the majority.” – John Templeton
- “An investment in knowledge pays the best interest.” – Benjamin Franklin.
- “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
- “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
- “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
- “If all the economists were laid end to end, they’d never reach a conclusion. -George Bernard Shaw
- “There are old traders and there are bold traders, but there are very few old, bold traders.”-Ed Seykota
- “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.”
- “As long as you enjoy investing, you’ll be willing to do the homework and stay in the game.” -Jim Cramer
- “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
- “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
- “The policy of being too cautious is the greatest risk of all.” -Jawaharlal Nehru
- “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
- “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
- “The four most dangerous words in investing are: ‘this time it’s different.” -Sir John Templeton
- “Money doesn’t make you happy. I now have $50 million but I was just as happy when I had $48 million.” -Arnold Schwarzenegger
Videos
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