Market Records Powered By Biden’s Early Stimulus Signing On Thursday

• Oppenheimer’s analyst Hartaj Singh recently reiterated his OUTPERFORM Rating and his Price Target of $17. 

• Recently, NeuBase 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.

• Largest shareholders include David Einhorn’s Greenlight Capital Inc (9%).

• We expect to see the company to announce an update on its work in Huntington’s Disease and also sign a corporate deal of some kind prior to the end of April 2021 based on recent conversations & expectations of management.

Natural-Killer cell (NKcell) focused biopharmaceutical firm Fate Therapeutics (FATE) closed at $97.66/share, +8.69% after recently establishing a new all-time high of $121.16.

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

• FATE also recently 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.

• We started with Fate over 3 years ago when it was in the $3 range.

• 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.”

• Monday, 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.

• Last week, 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.”

• Recently, INVO announced that 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.

• 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. 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.

• INVO’s Management Issued a letter to shareholders recently that spoke to their key developments and future initiatives that have positioned their product INVOcell® within the severely underserved fertility market. PLEASE read the story here.

• INVO received BUY Ratings from both Roth Capital ($5 PT) & Collier International Securities ( $5.75 PT) in December, 2020.  

• 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.”

• 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.

• Today, 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 today’s story.

• 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.”

• Recently, Atossa’s President and CEO Dr. Steven C. Quay issued his annual Letter to Stockholders highlighting key accomplishments and strategy for 2021. Please view it here.

• Recently, Atossa 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.  Yesterday, I hosted  Tribe Public’s Webinar Presentation and Q&A Event with Steven Quay, MD, PhD, CEO & Founder & Kyle Guse CFO of Atossa Therapeutics (NASDAQ: ATOS) who delivered a presentation titled “The Important Role of COVID-19 Therapeutics In A Post-Vaccine World.” They also addressed Q&A session at the end of the presentation. Please view it here.

• Recently, Atossa announced that based on substantially positive results achieved with the patients enrolled to date in its Australian open-label Phase 2 clinical study of oral Endoxifen administered in the “window of opportunity” between diagnosis of breast cancer and surgery, Atossa has halted the study and is accelerating its Endoxifen program in the United States. “It is a welcome event to halt an ongoing clinical trial because the results are so overwhelmingly positive,” commented Steven Quay, M.D., Ph.D., Atossa’s President and Chief Executive Officer. “Data from the first six patients in our Australian Phase 2 window of opportunity study shows a 74% average reduction in Ki-67, which is a common measure of tumor cell activity, and that at the time of surgery all patients had Ki-67 levels lower than 25%, which is an important threshold to improve long-term survival as identified in studies by others. We believe that additional enrollment will not alter these positive results so we are terminating the study early. This saves at least a year on the development time line allowing us to accelerate clinical development in the Unites States. We look forward to reporting final data from all patients in the study and sharing our continued progress in the development of oral Endoxifen.”

•  Atossa recently raised ~$81M in gross proceeds affording the company a significant development runway and many more options to be considering. 

• Atossa is seeking in the near term to get an FDA nod to move into a Phase 2 trial with its nasal spray COVID-19 therapy.