Large Caps Take A Dive While MicroCaps Find Ground Again This Week

“I made my first investment at age eleven. I was wasting my life until then.” – Warren Buffett

• Shares of Chinook Therapeutics (KDNY), a clinical-stage biotechnology company developing precision medicines for kidney diseases, closed at $14.75, -2.38%. Chinook is a clinical-stage biopharmaceutical company discovering, developing and commercializing precision medicines for rare, severe chronic kidney diseases, a severe and growing worldwide problem with a lack of effective treatments often leading to dialysis, transplantation, and high costs to health care systems. In the U.S. alone, kidney diseases affect an estimated 37 million people and account for over $120 billion in annual costs. 

• • 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 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 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.”

• • Recently, 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.

• • Chinook has well-funded development programs with participation in a $115 million private placement financing concurrent with the close of a merger with Aduro Biotech in Q4 2020 from top-tier healthcare investors including, EcoR1 Capital, OrbiMed Advisors, funds managed by Rock Springs Capital, Fidelity Management and Research Company LLC, Avidity Partners, Surveyor Capital (a Citadel company), Ally Bridge Group, Monashee Investment Management LLC, Northleaf Capital Partners, Janus Henderson Investors, Sphera Biotech and others.

• Shares of Natural-Killer cell (NKcell) focused biopharmaceutical firm Fate Therapeutics (FATE) closed at $85.34 & up from last Friday’s close of $77.99. 

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

• • Recently, Fate Therapeutics (FATE) reported business highlights and financial results for the fourth quarter ended December 31, 2020.

• • Fate announced that the Company will host a conference call and live audio webcast on Wednesday, February 24, 2021 at 5:00 p.m. ET to report its fourth quarter and full year 2020 financial results and provide a corporate update. Learn more here. 

• • Recently, Fate presented a patient case study from the Company’s Phase 1 clinical trial of FT596, its universal, off-the-shelf, CD19-targeted chimeric antigen receptor (CAR) natural killer (NK) cell product candidate, at the 62nd Annual Society of Hematology Annual Meeting and Exposition and the street loved it. NK cells are the body’s first line of defense against viral infections and cancerous cells with an innate ability to rapidly seek and destroy transformed cells. NK cell therapy has the potential to 1) target multiple pathogenic antigens with measurably more efficient cytotoxicity, 2) be better controlled to reduce risk of cytokine storms and 3) be produced from a variety of sources without relying on patient-specific immune cells. Dr. Wayne Chu, Senior Vice President, Clinical Development of Fate Therapeutics stated, “The safety, pharmacokinetics and clinical activity observed following both the first and second single-dose treatment cycles of FT596 are compelling, especially when considering that the administered cell dose was significantly lower than the recommended cell dose of FDA-approved autologous CD19-targeted CAR T-cell therapies and that the heavily pre-treated patient was refractory to last prior therapy. We are excited the CAR component of FT596 has shown clinical activity at this low dose level, and we continue to enroll patients in dose escalation with FT596 as a monotherapy and in combination with rituximab. Our recent Phase 1 clinical data with FT516 in combination with rituximab, which demonstrate the potential of our novel hnCD16 Fc receptor to potentiate ADCC and drive complete responses, support our belief that the multi-antigen targeting functionality of FT596 may offer best-in-class potential for patients with B-cell malignancies.” 

• • We have made another investment in a private company called Cytovia Therapeutics that owns its own NK cell platform that some investors are calling “FATE 2.0”. They are seeking to go next year in Q2/Q3 as there is room in the markets for another NK cell company. Their website is www.cytoviatx.com.

• Shares of 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 $1.77 & up from last Friday’s closes of $1.63/share close last Friday and is trading 20.11M shares a day.

• • 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 Monday, March 22, Atossa  announced that it had entered into a securities purchase agreement with institutional investors to purchase $50 million of its shares of common stock and warrants in a registered direct offering priced at-the-market under Nasdaq rules. Read Story.  Atossa has now raised ~$141M in gross proceeds (via registered directs and warrant exercises) since Dec. 2020 affording the company a significant development runway and many more options to be considering including acquisitions. 

• • Recently , 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.

• • Recently 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.” Learn more here.

• • Atossa recently announced updated findings following 26 months of Expanded Access (or “compassionate use”) single-patient studies of Atossa’s Endoxifen. “To date, the patient has not had a recurrence of breast cancer, as assessed by clinical breast examination and mammography; has not had treatment-related changes in periodic laboratory blood tests and general clinical examinations; and, the treatment has been well tolerated, including an absence of typical vasomotor symptoms commonly associated with tamoxifen (for example, night sweats and hot flashes), an FDA-approved drug frequently prescribed for breast cancer treatment,” commented Sidney Goldblatt, M.D., Principal Investigator. “This patient, like many breast cancer patients, was reluctant to take tamoxifen because of the well-documented side effects associated with that drug and because she lacked the proper liver enzymes to properly metabolize tamoxifen. We are very encouraged by this patient’s experience with our Endoxifen over the past two years. Her experience serves as a model for ongoing development efforts,” commented Steve Quay, Ph.D., M.D., Atossa’s President and CEO.

• Shares of  INVO Bioscience, Inc. (INVO), 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, closed at $4.32 up from the close of $4.08/share last Friday. 

• • April 22,  INVO announced that it has joined in supporting RESOLVE: The National Infertility Association, a non-profit action-based, infertility and family building advocacy organization who strive for increased access to all family building options. RESOLVE is currently hosting their National Infertility Awareness Week, from April 18 to April 24 (#NIAW2021). “We are excited to be supporting RESOLVE’s mission to ensure that all people challenged in their family building journey reach resolution through being empowered by knowledge, supported by community, united by advocacy, and inspired to act. We believe that our effective and affordable treatment solution for patients diagnosed with infertility, INVOcell, can help address key infertility treatment challenges regarding cost, capacity constraints and access to care to help serve the very large, underserved patient population,” stated Steve Shum, CEO of INVO Bioscience. Please read the story here. 

• • On April 19, INVO announced the execution of a partnership agreement with Lyfe Medical, LLC (“Lyfe Medical”) focused on the expansion of the INVOcell solution in Northern California (with an area population of ~8 million people). “We believe that INVOcell can help address key infertility treatment industry challenges regarding cost & capacity constraints to help serve the very large underserved patient population. We are excited to sign this partnership agreement with the team at Lyfe Medical, a physician-led premier-level fertility practice, to establish an INVO center in the Northern California fertility market to help further our mission to increase access to care and expand fertility treatment across the globe. Lyfe has shown a strong commitment to bringing INVOcell into this region. We look forward to ramping up our respective requirements and begin operations later this year,” stated Steve Shum, CEO of INVO Bioscience. Please read the story here. 

• • 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.

• • After the close March 30, INVO announced 2020 financial results and highlights.  Steve Shum, Chief Executive Officer of INVO Bioscience stated, “In the face of a difficult year for many industries, including the fertility business, I am extremely proud of the accomplishments of the entire INVO Bioscience team. During the year, we put in place a number of building blocks for the future, which are already beginning to pay dividends. Recently we announced our plan to open our first U.S.-based INVOcell clinic in partnership with some of the most highly accomplished INVOcell practitioners in the world. Our partners are not only extremely well-versed in the INVOcell technology, but also have a proven track record of successful implementation of the platform within an established clinical setting. A few months prior, we announced that we plan to open dedicated INVOcell clinics in Mexico with Dr. Francisco Arredondo and Dr. Ramiro Ramirez, who were also early adopters of the INVOcell solution and have established a successful track record of successful implementation of INVOcell in a clinical setting. We believe the combination of strong distribution partners such as Ferring in the U.S. and other locations around the world, coupled with dedicated INVOcell clinics partnerships which INVO Bioscience has an equity interest in, position the Company well for the future. Another key development during the year was the availability of additional positive real-world usage data highlighting the success of INVOcell, including a published peer-reviewed manuscript (report). We expect to see further data from this year’s SART information in the near future. In our opinion, this expanded retrospective, real world validated data is extremely valuable to our commercial efforts and builds confidence with practitioners. We believe that this expanding portfolio of usage data will play an important role in expanding and accelerating market adoption.”

• • On March 15, INVO announced the signing of a 50/50 joint venture agreement in partnership with reproductive specialists Dr. Nicholas Cataldo, MD, MPH, Dr. Karen R. Hammond, DNP, CRNP, and Lisa Ray, MS, ELD, to open the first Joint Venture INVO-exclusive clinic in the United States.

• • On March 8, after the close INVO announced that they has agreed to an amendment of their agreement with Ferring Pharmaceuticals that provides for an increase in the number of INVO company-owned US-based clinics initially allowable under the agreement and removes certain geographical restrictions. The amendment also adjusted the remaining annual 2020 minimum contractual product purchase requirement, whereby Ferring will place a $501,000 order, which will be recognized as revenue by INVO Bioscience in the first quarter of 2021. READ STORY.

• • On March 1, INVO announced the Company has received approval by COFEPRIS to import INVOcell into Mexico. In late 2020, INVO Bioscience established a joint venture focused on establishing fertility centers dedicated to offering INVOcell, with the initial center, called Positib Fertility, to be located in the city of Monterrey, Mexico. Steve Shum, CEO of INVO Bioscience, commented, “We are extremely pleased to have received approval by COFEPRIS to begin importing INVOcell into Mexico. This was a key step in the process to open our first joint venture owned clinic in the large and growing Mexico market for infertility services. Our internal team along with our JV partners have and continue to work aggressively and with a relentless focus to bring the INVOcell treatment option to the many patients in need of care within Mexico.”

• • On Jan 27, INVO announced it has advanced its commercialization efforts into the European fertility market by securing initial orders of INVOcell in Madrid and Barcelona, Spain. INVOcell will initially be available at three separate existing fertility clinics which have placed orders and commenced training. Please read the story here.

• • 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. Since January 2019, INVO Bioscience has signed commercialization agreements in the United States, India, as well as parts of Africa and Eurasia and Mexico for the INVOcell device.

• Shares of NeuBase Therapeutics (NBSE) closed trading this week at $5.71/share. 

• • On April 22, NBSE announced the pricing of an underwritten public offering of 8,000,000 shares of its common stock, at a price to the public of $5.00 per share. The gross proceeds to NeuBase from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by NeuBase, are expected to be approximately $40 million, excluding any exercise of the underwriters’ option to purchase additional shares of common stock. In addition, NeuBase has granted the underwriters a 30-day option to purchase up to an additional 1,200,000 shares of its common stock at the public offering price, less underwriting discounts and commissions, to cover over-allotments, if any. All of the shares of common stock in the offering are being sold by NeuBase. RBC Capital Markets, Oppenheimer & Co. Inc. and Chardan are acting as the joint book-running managers for the offering, and National Securities Corporation is acting as co-manager. NeuBase intends to use the net proceeds from the offering for general corporate purposes, working capital and development of its product candidates and pipeline expansion. This offering is expected to close on or about April 26, 2021, subject to the satisfaction of customary closing conditions.

  • On April 8, NBSE announced that it will host a virtual R&D day for investors and analysts on Tuesday, June 8, 2021, from 12:30 p.m. to 2:30 p.m. EDT. During the event, NeuBase will present new data, along with an in-depth review of the Company’s pipeline of drug candidates – including in Huntington’s disease, myotonic dystrophy type 1, and a new oncology program for a target that has previously been thought of as undruggable – as well as an introduction to the expanded management team. Additional details will be made available prior to the event. The event will be webcast live on NeuBase’s website at https://ir.neubasetherapeutics.com/news-events/ir-calendar. Following the live webcast, a replay will be available on the Company’s website and archived for approximately 90 days.

  • Recently, Neubase reported its financial results for the three-month period ended December 31, 2020. Review the story here.

  • NBSE recently announced the execution of a binding agreement to acquire infrastructure, programs and intellectual property for several peptide-nucleic acid (PNA) scaffolds from Vera Therapeutics, formerly known as TruCode Gene Repair, Inc. The technology has demonstrated the ability to resolve disease in genetic models of several human indications. The acquisition was reported to bolster NeuBase’s capabilities and reinforces the Company’s position as a leader in the field of genetic medicine. Read the complete story.

• • NeuBase is developing the next generation of gene silencing therapies with its flexible, highly specific synthetic antisense oligonucleotides. The proprietary NeuBase peptide-nucleic acid (PNA) antisense oligonucleotide (PATrOL™) platform allows for the rapid development of targeted drugs, increasing the treatment opportunities for the hundreds of millions of people affected by rare genetic diseases, including those that can only be treated through accessing of secondary RNA structures. Using PATrOL technology, NeuBase aims to first tackle rare, genetic neurological disorders.