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Growth Concerns Flourish During Hump Day’s Stock Market Session – $ATOS $FATE $INVO $PHAT $XBI $WBER $ZLAB Rise!

By John F. Heerdink, Jr.
Quote of the Day “Our chief want is someone who will inspire us to be what we know we could be.” – Ralph Waldo Emerson
 

Talk around the markets today was centered around Fed Chair “Uncle Jerry” Powell’s statement to the Senate, which confirmed that he and the Fed were “strongly committed” to lowering inflation. Nothing new. He also admitted that a U.S. recession is a still a “possibility” & that he sees a “very challenging” environment for the economy to realize a “soft landing.” The markets also chewed through President Biden’s request for suspension of the federal & state gas tax for 3 months waging his own battle against inflation. In response, investors, market pundits, & members of media sang a ‘growth concerns’ sad kind of song throughout the session. Oil prices remained very high and closed at $106.07/bbl, but did drop 3.2%.  

Of note, the macroeconomic schedule did offer the Weekly Mortgage Applications Index report that showed a 4% rise. The yield curve also pulled back significantly as the 2-yr yield moved down 17 basis points to close at 3.05% & 10-yr yield moved down 15 basis points closing at 3.16%.   

A little surprisingly, the major indices effectively stayed pat, only tailing off slightly across the board after yesterday strongly positive move. The S&P 500 closed at 3,759.89 (-.13%) while the energy sector led all sectors lower with a 4.2% decline.  The Dow 30 closed at 30,483.13 (-.15%). The Nasdaq closed at 11,053.08 (-.15%). The small caps on the Russell 2000 closed at 1,690.28 (-.22%). The MicroCaps followed suit as the iShares Micro-Cap ETF closed at $105.90, -.54%.

On the positive side once again today, the biotech stocks rose significantly as the SPDR S&P Biotech ETF (XBI) closed at $71.79, +2.51% and continuing to find its way back from the recently established 52-wk low. The 52-wk range is now $61.78 – $141.50. The iShares Biotechnology ETF (IBB) closed at $113.25, +1.23%. The 52-range is $105.38 – $177.37.  

The CBOE Volatility Index (^VIX) closed at $28.95, closing down 4.11% and traded within the tight range of $28.78 – $30.43.

Around the money and precious metals’ tree, the U.S. Dollar Index closed at 104.21, -.22% & Bitcoin (BTC) fell sharply currently at 19,930.74, -4.52% over the last 24-hours.  Gold prices closed at $1,839 oz., +6/oz. & silver closed at $21.44/oz., -$.20/oz. on the day. Two mining producers closed the day as follows:  Hecla Mining Company (HL) closed at $4.23, -4.51% and First Majestic Silver Corp. (AG) closed at $7.82, -3.22%.  


FURTHER AFIELD 
 
Shares of Zai Lab Limited (NASDAQ: ZLAB), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, rose to $32.54, +12.01%. On June 10, ZLAB announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted two Breakthrough Therapy Designations for investigational repotrectinib for the treatment of patients with ROS1-positive metastatic NSCLC who have received one prior line of ROS1 TKI and one prior line of platinum-based chemotherapy (EXP-2) and for those with ROS1-positive metastatic NSCLC who have received one prior line of ROS1 TKI and no chemotherapy or immunotherapy (EXP-4). The Breakthrough Therapy Designations for repotrectinib were supported by the data from both global and Chinese TKI-pretreated ROS1-positive NSCLC patients enrolled in the Phase 1/2 TRIDENT-1 study.
 
Shares of Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, closed rat $7.73, +2.11%. On May 25, PHAT announced the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for vonoprazan as a treatment for adults for the healing of all grades of erosive esophagitis (EE) and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn. The FDA has assigned the application standard review and a Prescription Drug User Fee Act (PDUFA) target action date of January 11, 2023.
 
Shares of Weber, Inc. (WBER), the world’s leading barbecue brand, closed at $8.63, +10.36%. On May 16, WBER announced their Q2 results highlighting: Sequential Gross Margin Improvement Reflects Significant Progress Against Inflationary Cost Headwinds & Continued Execution Through Challenging Macroeconomic Environment.


 
 
 
 
On June 10, Cytovia Therapeutics, Inc.(ISLE), a biopharmaceutical company empowering natural killer (NK) cells to fight cancer through stem cell engineering and multi-specific antibodies, announced that the novel data it is presenting at the European Hematology Association’s annual congress in Vienna, Austria on June 10th, 2022 is now available on both the EHA and Cytovia websites.  
 
On June 9, Cytovia Therapeutics, LLC (ISLE), a global biotechnology company focused on empowering natural killer (NK) cells to fight cancer through multispecific antibodies and stem cell engineering, announced that Luca Scavo, CPA, MBA has been appointed as Chief Financial Officer and James Priour, MBA has been appointed as Chief Product Officer, both effective immediately. Mr. Scavo previously served as Chief Financial Officer (CFO) at Evelo Biosciences, Inc. (NASDAQ: EVLO). Prior to joining Evelo Biosciences, Mr. Scavo was the Senior Vice President and CFO of Roche Diagnostics North America. Prior to Roche Diagnostics, he held global leadership roles across the Roche organization for more than 20 years, including serving as Vice President, Chief Accounting Officer at Genentech, Inc. and CFO at Roche Latin America. Mr. Scavo also served as CFO at AstraZeneca, Spain and worked in a series of finance roles at Roche’s offices in Austria, New Jersey, and Switzerland. He holds a Certified Public Accountant (CPA) license in California, a Masters in Business Administration (MBA) from the Instituto de Empresa (Madrid-Spain), as well as a bachelor’s degree in Economics and Business from Universita’ Politecnica delle Marche (Italy). Mr. Priour brings over 30 years of leadership experience in drug development, portfolio strategy, commercialization, strategic partnership and alliance management, including experience in the oncology therapeutic area. Since 2020, Mr. Priour served as Chief Commercial Officer at Zymeworks, Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company focused on developing multi-specific drugs for HER2 overexpressing solid tumors. Prior to joining Zymeworks, Mr. Priour was at Amgen Corporate Headquarters in Southern California and served as the Global Marketing Lead for Kyprolis® (medication approved in relapsed or refractory Multiple Myeloma). Shortly thereafter, he was appointed to Global Product General Manager for the entire Myeloma franchise. He also held leadership roles at Amgen France in 2009, where he served as Business Unit Head for General Medicine, and in 2012, he became the General Manager of Amgen Australia & New Zealand. He also served as General Manager of Hungary for Bristol Myers Squibb in 2006. Mr. Priour started his career in 1992 with Procter & Gamble Pharmaceuticals, where he held various commercial leadership positions based out of their France, Belgium, Luxemburg and Cincinnati, USA corporate offices. Mr. Priour holds an MBA from the NEOMA Business School.
 
On May 18,  Cytovia Therapeutics, LLC , a global biotechnology company focused on harnessing the power of natural killer (NK) cells to fight cancer through multispecific antibodies and stem cell engineering presented at the AACR Special Conference on Advances in the Pathogenesis and Molecular Therapies of Liver Cancer, held from May 5-8, 2022, at the Westin Copley Place in Boston, Massachusetts. The conference is an in-person event and will not live-stream content, but Cytovia Therapeutics’s short poster video will be available for on-demand viewing by conference registrants after the conference and Cytovia Therapeutics’s poster will be available on its website under the “Resources” section. Learn more. 
 
On April 26, Isleworth Healthcare Acquisition Corp. (NASDAQ: ISLE) (“Isleworth”), a special purpose acquisition company and Cytovia Holdings, Inc., a biopharmaceutical company empowering natural killer (NK) cells to fight cancer through stem cell engineering and multi-specific antibodies announced they have entered into a definitive business combination agreement. Upon consummation of this combination, Isleworth will be renamed Cytovia Therapeutics, Inc. (the “combined company”) and its common stock and warrants are expected to remain listed on NASDAQ under the ticker symbols INKC and INKCW, respectively. “We are grateful for the strong support from new and existing investors and the team of seasoned entrepreneurs at Isleworth. We expect this transaction to accelerate the execution of Cytovia’s vision to advance NK therapeutics towards a cure for cancer” said Dr. Teper. “We are encouraged by our preclinical data recently presented at AACR, which supports advancing development of our iPSC-derived NK cells (iNK) and Flex-NK™ cell engagers for the treatment of Hepatocellular Carcinoma.”
 

VP WATCHLIST UPDATES 
 
Shares of Apple (AAPL) closed at $135.35, -.38%. Note that Apple enjoys a 6.82% weighting in the S&P 500. On June 14, Apple® and Major League Soccer (MLS) announced that the Apple TV® app will be the exclusive destination to watch every single live MLS match beginning in 2023. This partnership is a historic first for a major professional sports league, and will allow fans around the world to watch all MLS, Leagues Cup,1 and select MLS NEXT Pro and MLS NEXT matches in one place — without any local broadcast blackouts or the need for a traditional pay TV bundle.


 
tesla
 
Shares of Tesla (TSLA) closed at $708,26, -.40%. According to Reuters this week, a Black former elevator operator at Tesla Inc.’s flagship California assembly plant on Tuesday has rejected a $15M award in his lawsuit alleging racial abuse by coworkers. This apparently is opening the door for a new trial.
 
Also, reportedly, an RBC Capital Markets analyst has turned bullish on Tesla’s stock pointing to its “favorable” positioning.  
 
According to a regulatory filing on June 10, Tesla has planned a 3-for-1 stock split.
 
 
 
The Walt Disney Company (DIS) closed at $93.50, +.23%. Walt Disney World in Orlando, filed a patent titled “Robotic Sherpa,” which apparently describes a moving locker system that could move with theme park guests, while allowing all to access stored items at their discretion.
 
Reportedly, Disney has also recently won the television broadcast rights to Indian Premier League cricket matches for the next 5 years in a deal valued at approx. $3B, according to people familiar with the matter.
 
 
On the small side, Atossa Therapeutics (NASDAQ: ATOS), a clinical-stage biopharmaceutical company seeking to develop innovative proprietary medicines in oncology and infectious disease with a current focus on breast cancer and COVID-19, rose to an intraday high of $1.12 prior to closing at $1.07, +2.88% on 1.22M shares of trading volume.
 
On June 2nd, Atossa announced the appointment of Charles Butler, a 25-year veteran in the healthcare communications space, as vice president of investor relations and public relations. Prior to joining Atossa, Mr. Butler spent 10 years at Exelixis, Inc. where he managed all communications from the preclinical through commercial stage for multiple drugs. During his time at Exelixis, he was a part of the team that raised over $1B in equity and business development transactions. Prior to Exelixis, he worked at Ogilvy in New York and London. At Ogilvy he was part of the team that launched multiple blockbuster drugs for several pharmaceutical companies including Merck and Pfizer. While in London, he managed a 25+ person team, overseeing healthcare communications for the United Kingdom and Europe. He has also worked at Castlight Health, ICR, Adverum, Eiger Biopharmaceuticals and IN8bio, Inc. Mr. Butler graduated from George Washington University with a B.A. in Political Science.  “As Atossa continues to develop our pipeline both in breast cancer and COVID-19, the necessity for an in-house strategic manager for our communications has become an important priority and Charles’s extensive experience within the industry as a liaison for both investors and the media make him a valuable asset,” commented Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “The unique opportunity to be part of the Atossa team that is working to bring new products to market in breast cancer and other important diseases is exciting. It will allow me to leverage my many years of experience across the communications spectrum in biotechnology. I look forward to collaborating closely with management to ensure its strong message of innovation and patient care are clearly received in this crowded marketplace,” stated Charles Butler. 
 
On May 9, Atossa announced the financial results for the fiscal quarter ended March 31, 2022, and provides an update on recent company developments. Key developments from Q1 2022 and to date include: Received issuance of key U.S. patent covering Endoxifen directed to compositions of storage-stable Endoxifen and methods of treating hormone-dependent breast disorders using the storage-stable Endoxifen, Announced planned U.S. Phase 2 clinical study of Endoxifen in the neoadjuvant setting (prior to surgery) to compare Endoxifen to standard of care in premenopausal women with breast cancer. A CRO has been engaged to work on this study and the Company also intends to retain a leading U.S. research institution to help manage the study. The Company anticipates submitting an IND to the FDA in the second quarter of 2022, Completed Part B (second of four parts) of Phase 1b/2a clinical study of AT-H201 in Australia. “We continue to make steady progress with our Endoxifen programs: one to reduce tumor cell activity in breast cancer patients in the neoadjuvant setting; and another to reduce dense breast tissue in women,” commented Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “Our Phase 2 study in women with measurable breast density continues to enroll participants in Stockholm and we have been preparing to submit a request (IND) to the FDA this quarter to open a Phase 2 study in the neoadjuvant setting here in the Unites States. We began 2022 with significant progress in our COVID-19 program, both initiating and completing key parts of our Phase1b/2a trial in Australia for AT-H201, and we have now completed the first two parts of that study.” 
 
On April 20, Atossa announced it has completed enrolling participants in Part B of its Phase 1/2a clinical study of AT-H201 in Australia, consisting of multiple ascending dose cohorts in healthy participants. AT-H201 is being developed as an inhalation therapy for moderately to severely ill hospitalized COVID-19 patients and for “long-haul” patients with post-infection pulmonary disease.“Part B of the study was successfully completed and, subject to approval from the ethics committee, we will now proceed to enroll the next group of participants,” said Steven Quay, M.D., Ph.D., Atossa’s CEO and President. “Despite widespread availability of vaccines, many areas of the world are seeing a recent surge in COVID-19 cases. There continues to be a strong need for additional therapies to combat COVID-19.” LEARN MORE. 
 
On March 8, Atossa announced that the U.S. Patent and Trademark office has issued a new patent further strengthening Atossa’s intellectual property in its proprietary therapy Endoxifen, which is under development for breast cancer and other breast conditions. U.S. Patent No. 11,261,151 (the ‘151 Patent) is titled “Methods for Making and Using Endoxifen” and is directed to compositions of storage-stable Endoxifen and methods of treating hormone-dependent breast disorders using the storage-stable Endoxifen. “We are very pleased with the scope and breadth of this new key patent,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “Patents covering the composition of matter of new therapies are critical to protect markets from generic competition. The ‘151 Patent,’ with its estimated expiration in 2038, strengthens our intellectual property estate and should create long-term stockholder value.” Atossa is developing its proprietary Endoxifen in two clinical settings: one to reduce tumor cell activity in breast cancer patients in the neoadjuvant setting, meaning prior to surgery; and another to reduce dense breast tissue in women. A Phase 2 study is currently underway in women with measurable breast density and Atossa plans to submit a request (IND) to the FDA to open other Phase 2 in the neoadjuvant setting in the next quarter. Atossa’s neoadjuvant program is focused on breast cancers that are classified as estrogen receptor positive (ER+). Although there are numerous neoadjuvant treatments for breast cancers that are not ER+, there are few neoadjuvant treatments for ER+ breast cancer which comprises about 78% of all breast cancers. We believe there is a compelling need for therapy with our Endoxifen in this setting. An estimated ten million women in the U.S. have mammographic breast density, or MBD, for which there is no FDA-approved treatment. MBD is an emerging public health issue and studies conducted by others have shown that MBD increases the risk of developing breast cancer and that reducing MBD can reduce the incidence of breast cancer. The American Cancer Society estimates that in the U.S. in 2022, 287,850 women will be diagnosed with breast cancer, 47,550 of which will be under the age of 50 and 43,250 of which will die from the disease.
 
On Jan. 27, Atossa issued the annual letter from President and CEO Dr. Steven C. Quay to Atossa stockholders.  The letter Bega as follows: “The last two years have changed the face of public health and uncovered the urgency to develop products not only to prevent widely spread infectious diseases, but to treat them with the same level of focus and dedication applied to prevention. Despite the launch of highly efficacious vaccines during 2021, the toll that COVID-19 was taking on public health was not reduced. The rise of the Omicron variant toward the end of the year, and emerging long-term impact of long COVID, remain an important public health priority, and one that Atossa is dedicated to addressing. A key feature of the original SARS-CoV-2 virus, and that is retained in both the Delta and Omicron variants, is the furin cleavage site found on the Spike protein which facilitates viral infection. Our COVID-19 programs under development are designed to interact with this cleavage site so they are expected to be effective against both current and future COVID-19 variants that continue to contain a furin cleavage site. In the meantime, we are also very excited about the ongoing development of our breast health programs with our proprietary drug Endoxifen, with one Phase 2 study underway and another expected to commence in the next quarter. We raised over $110 million in capital in 2021 and we are well positioned to execute on our programs in 2022.” Click here to read the balance of the letter now.
 
On Jan. 18, Atossa announced it is advancing to enroll participants in Part B of its Phase 1/2a clinical study of AT-H201 in Australia, consisting of multiple ascending dose cohorts in healthy participants. The nebulized formulation, AT-H201, is being developed as an inhalation therapy for moderately to severely-ill hospitalized COVID-19 patients and for “long-haul” patients with post-infection pulmonary disease. Part A of the study, which consisted of a single ascending dose group of 4 cohorts of healthy participants, has now been completed. The Australian Human Research Ethics Committee has reviewed the safety data from Part A and has approved the study to proceed to Part B. “The results of the first part of the study were extremely encouraging and the ethics committee concluded we may now proceed to enroll the next group of participants,” said Steven Quay, M.D., Ph.D., Atossa’s CEO and President. “A record number of hospitalizations driven by the Omicron variant is producing a crisis at many healthcare facilities. Additional therapies to combat COVID-19 are desperately needed.” The Phase 1/2 a placebo-controlled study will enroll a total of 60 healthy participants and moderately-ill hospitalized COVID-19 patients. The study has 4 parts: Part A – a single ascending dose part, Part B – a multiple ascending dose part, Part C – a combination part in healthy individuals, and Part D a combination in COVID-19 infected patients. The study is being conducted by Avance Clinical Pty Ltd., a leading Australian clinical research organization. AT-H201 is a proprietary combination of two drugs previously approved by the FDA to treat other diseases and by other administration routes. AT-H201 is intended to be inhaled via a nebulizer to improve compromised lung function for moderate to severely ill, hospitalized COVID-19 patients and for “long-haul” patients with post-infection pulmonary disease. In May 2020, we completed in vitro testing of AT-H201 which showed that the components of AT-H201 inhibit SARS-CoV-2 infectivity of VERO cells, which is a standard cell type being used to study infectivity of the coronavirus. The Phase 1/2a study in Australia and other clinical studies must be successfully completed and regulatory approvals must be obtained before AT-H201 may be commercialized. No assurance can be given than studies will be successful or that regulatory approvals will be obtained.
 
 
Shares of Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, closed at $23.61, +6.21% after recently reporting their business highlights and financial results for the first quarter ended March 31, 2022 on May 4th. “We have made significant progress across our disease areas, operations, and collaborations in early 2022, including preparing for submission to the FDA of our multi-disciplinary RMAT briefing package to inform pivotal study readiness in relapsed / refractory aggressive lymphoma, as well as our FT596 plus R-CHOP clinical protocol to initiate investigation in first-line patients,” said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. “We are also poised to treat the first solid tumor patient with FT536, our multi-antigen targeted CAR MICA/B NK cell product candidate, and have initiated IND-enabling activities for two CAR NK cell product candidates under our collaboration with Janssen. We look forward to providing clinical updates for our multiplexed-engineered, iPSC-derived NK and T-cell product candidates across our disease franchises in the second half of 2022.”
 
 
 
Shares of InMed Pharmaceuticals Inc. (NASDAQ: INM), a leader in the development, manufacturing and commercialization of rare cannabinoids, closed at $.4881/share, -9.61%.
 

On June 14, InMed announced that a peer-reviewed scientific study entitled “Effects of Rare Phytocannabinoids on the Endocannabinoid System of Human Keratinocytes” has been published in the International Journal of Molecular Sciences. The study, in collaboration with Dr. Mauro Maccarrone, Professor and Chair of Biochemistry at the Department of Biotechnological and Applied Clinical Sciences, University of L’Aquila, Italy, highlights the biological activity of tetrahydrocannabivarin (“THCV”), cannabichromene (“CBC”) and other rare cannabinoids and their potential role in addressing various skin conditions. In the peer-reviewed study, researchers analyzed the effects of rare cannabinoids THCV, CBC, cannabigerol (“CBG”) and cannabigerolic acid (“CBGA”) on the major endocannabinoid system elements in skin cells. Using a widely recognized in vitro model of human keratinocytes, researchers studied how these cannabinoids interacted with several receptors including cannabinoid receptors and other endocannabinoid system components. In summary, each cannabinoid had distinct biological activity via the endocannabinoid system. In particular, THCV was shown to perform as a cannabinoid receptor 1 (“CB1”) antagonist and have a high affinity for the human transient receptor potential vanilloid 1 (“TRPV1”), which is involved in skin sensation, as did CBC albeit to a lesser extent. The results from the study support additional research of these rare cannabinoids for their potential effect on skin conditions.“This study represents the first systematic analysis of the effects of the rare cannabinoids THCV, CBC, CBGA and CBG on the major endocannabinoid system elements using human keratinocytes. These initial observations should be considered when exploring the therapeutic potential of rare cannabinoids for the treatment of human skin disease,” said InMed’s scientific advisor, Dr. Mauro Maccarrone. “This peer-reviewed study provides important scientific research investigating the distinctly different physiological effects of rare cannabinoids,” said Dr. Eric Hsu, Senior VP, Preclinical Research and Development. “As we continue to expand our portfolio of rare cannabinoids, including THCV and CBC, evidence-based research is imperative to improving our understanding of their biological activity. There is growing interest in the potential benefits of rare cannabinoids and this study represents InMed’s commitment to contributing to the body of research of rare cannabinoids.” The journal article can be accessed here: https://www.mdpi.com/1422-0067/23/10/5430.

 
On June 9, InMed launched B2B sales of the rare cannabinoid delta 9-dominant tetrahydrocannabivarin (“d9-THCV”) into the health and wellness sector via its wholly-owned subsidiary, BayMedica LLC. Shane Johnson, MD, SVP and General Manager of BayMedica stared,  “We are very excited to launch our highly anticipated d9-THCV and further enhance BayMedica’s growing product portfolio. THCV is one of the few rare cannabinoids that has been researched in early clinical trials for various therapeutic effects, fueling significant interest by end-product manufacturers and consumers alike. In anticipation of this launch, we have expanded internal sales and marketing infrastructure, developed new distribution channels and optimized the supply chain to ensure a consistent and reliable supply of a high quality product. As this market continues to mature, we are well positioned to be a leading supplier of rare cannabinoids to the health and wellness industry. We currently have several high-value, rare cannabinoids in various stages of commercial development and will continue to expand our cannabinoid portfolio over the coming years”.

On June 2, InMed Pharmaceuticals Inc. announced that it has entered into securities purchase agreements with a single healthcare-focused institutional investor for the issuance and sale of 4,079,256 of its common shares at a purchase price of $0.858 per share (or pre-funded warrant in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, InMed has also agreed to issue and sell to the investor 1,748,250 common shares (or pre-funded warrant in lieu thereto) at the same purchase price as in the registered direct offering. In addition, the Company has agreed to issue to the investor in the offerings unregistered preferred investment options (the “investment options”) to purchase up to an aggregate of 5,827,506 common shares. The aggregate gross proceeds to the Company of both offerings are expected to be approximately $5 million. The offerings are expected to close on or about June 6, 2022, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offerings to continue pipeline development, advance commercial activities and for general working capital purposes. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offerings. The unregistered investment options to be issued in the offerings will be exercisable immediately upon issuance at an exercise price of $0.74 per share and will expire six and one-half years from the date of issuance. The Company also has agreed that certain existing warrants to purchase up to an aggregate of 4,480,771 common shares of the Company that were previously issued to the investor, with exercise prices ranging from $2.848 to $5.11 per share and expiration dates ranging from July 2, 2026 to November 16, 2026, will be amended effective upon the closing of the registered direct offering so that the amended warrants will have a reduced exercise price of $0.74 per share, will not be exercisable until six months following the closing of the registered direct offering and will expire seven years following the closing of the registered direct offering.

On May 5, InMed announced that its subsidiary, BayMedica, will be providing rare cannabinoids for use in Radicle Science, Inc.’s Radicle Energy rare cannabinoid study to assess the effects of delta-9 (“d-9”) dominant tetrahydrocannabivarin (“THCV”) on energy, focus/attention, appetite and weight/BMI. BayMedia will be supplying its highly pure d-9 dominant THCV, formulated into a proprietary lozenge manufactured by Trokie. This rare cannabinoid, consumer-based investigation will measure the effects of the Company’s d-9 dominant THCV in a randomized, blinded, placebo-controlled study in up to 900 adult participants aged 21 and older who reside in the United States. The study includes three dosing groups including a placebo group (no THCV), each delivered via Trokie’s proprietary lozenge technology. The study is set to begin participant recruitment in May and will run for a four week period starting in June with results expected during the summer. The study is part of Radicle Science’s large scale investigations into several rare cannabinoids involving up to 10,000 participants in total, the largest of its kind to date.

On April 28, InMed announced the publication of a patent application in North America for several cannabinoid analogs. This patent application has broad claims directed to their molecular structure, uses and methods of manufacturing. Entitled “Cannabinoid Analogs and Methods for their Preparation”, the patent application describes several new cannabinoid-related chemical compounds that have not been previously described. If granted, the broad patent application allows for the creation of several variations of novel cannabinoid compounds, producing a robust library of proprietary new chemical entities (‘NCEs’). Scientists at BayMedica, LLC, InMed’s subsidiary in the US, designed and produced these cannabinoid analogs. These NCEs are expected to offer similar or improved therapeutic effects compared to their parent (naturally occurring) cannabinoid with modifications that may make them preferred candidates to treat specific diseases.


Eric Hsu, SVP, Pre-Clinical Research and Development for InMed commented; “We believe rare cannabinoids hold tremendous therapeutic potential that may address a number of unmet medical needs. This patent covers the selective modification of naturally occurring cannabinoids to target specific properties for pharmaceutical development. Such patent protection is an important component to ensure long-term commercial exclusivity as we continue to invest in R&D.”

 
On April 21, InMed announced it has launched B2B sales of the rare cannabinoid cannabidivarin (“CBDV”) to wholesalers, suppliers and end-product manufacturers in the health and wellness sector through its US subsidiary, BayMedica LLC. “Ensuring a reliable, large volume source of highly pure, bioidentical CBDV is an important step forward in the health and wellness sector. CBDV has been researched for its therapeutic potential in several disease areas such as autism spectrum disorder,” said Shane Johnson, MD, SVP and General Manager of BayMedica. “Whether you are a researcher or product developer at a multinational consumer package goods (‘CPG’) company, the ability to access highly pure and consistent active ingredients, free from contaminants typically found in plant-sourced cannabinoids such as pesticides, heavy metals, or potentially even THC, is a fundamental requirement. BayMedica’s cannabinoid manufacturing technologies provides exactly that value and we are excited to continue to introduce to the market additional rare cannabinoids that have previously not been abundantly accessible, including adding THCV to our portfolio in the immediate future.” LEARN MORE.
 
 
Shares of INVO Bioscience, Inc. (NASDAQ: INVO), a commercial-stage fertility company focused on expanding access to advanced treatment worldwide with its INVOcell® medical device and the IVC procedure it enables, closed at $.7945, +1.86% and has traded up to $.8343, +5.01% in the aftermarket .
 
***INSIDER BUYING ALERT***– On Friday June 3, after the close, a number of Form 4’s were filed c. at www.sec.gov confirming that the CEO, COO, CFO and 5 members of the board of directors purchased shares at $.95/share on June 1, 2022. Here’s the link to view all of the share purchases. 
 
After the market closed May 16, INVO reported financial results for its first quarter 2022, ended March 31, 2022 and highlighted the following: The three INVO Centers in Birmingham, Alabama, Atlanta, Georgia, and Monterrey, Mexico experienced a 40% increase in patient inquiries and consultations compared to the 4th quarter of 2021. This, in part, is the result of our locally targeted marketing efforts and is a positive indicator for potential treatment cycle growth in the coming periods, Announced plans to open additional INVO Centers in Tampa, Florida, and Kansas City, Missouri, in addition to the previously announced planned clinic in the San Francisco Bay Area, Signed an exclusive distribution agreement with Onesky Holdings Limited (“Onesky”) for mainland China (excludes Hong Kong, Macau and Taiwan). The exclusivity is subject to minimum annual purchase amounts over a 5-year term starting upon product registration, the cost of which is to be borne by Onesky, Processed initial product orders from direct sales to U.S. IVF clinics and engaged with approximately 80 clinics, including both new relationships and those already trained on the INVOcell and IVC by Ferring, & Received product orders from our Spain, Pakistan and Nigeria partnerships.
 
On April 28, INVO announced that in celebration of this year’s National Infertility Awareness Week (“NIAW”), three eligible patients will be granted a full IVC treatment cycle free of charge. The grant program, including patient selection, will be launched in the coming weeks. NIAW is a movement, founded in 1989 by RESOLVE, with a mission to empower patients and help those struggling to build a family. “We are committed to helping people suffering with infertility challenges have access to effective and affordable care,” stated Steve Shum, INVO CEO. “This grant program will benefit selected recipients and is part of our efforts to build awareness and educate patients on INVOcell as an effective and available treatment. We believe our INVOcell technology and the IVC treatment can provide an affordable solution for patients diagnosed with infertility, and can help address key industry challenges regarding cost, capacity constraints and access to care for the large, underserved patient population. We have three operational INVO Centers treating patients in Birmingham, Alabama, Atlanta, Georgia, and Monterrey, Mexico, with others scheduled to open in the San Francisco, Tampa and Kansas City areas later this year. In collaboration with our partners in Atlanta, we are pleased to offer this grant program and encourage people with fertility challenges to reach out to our INVO Center to check eligibility and receive details.” Bloom Fertility, an INVO Center, 6 Concourse Parkway, Suite 250., Atlanta, GA 30328, Ph 678-597-9933, hellobloomfertility.com.
 
On April 14, INVO Bioscience announced plans to open an INVO Center in Kansas City, Missouri. The Kansas City INVO Center will focus on patients in need of advanced fertility care utilizing the efficient, effective, and affordable INVOcell® solution. The Company currently has three operational INVO Centers treating patients in Birmingham, Alabama, Atlanta, Georgia, and Monterrey, Mexico, with others scheduled to open in the San Francisco and Tampa areas. The Company evaluates several criteria and data points as part of its efforts to identify markets suitable for INVO Centers. Based on an analysis of current population statistics, we believe that Kansas City may have upwards of 33,000 patients suffering with Infertility. With an estimated 1,500 IVF treatments annually, there exists a large gap of available care to treat local demand. Similar to other INVO Centers, the Company expects to engage physician partners to support its efforts in the Kansas City market.
 
 
 
Shares of NeuBase Therapeutics (NASDAQ: NBSE), a biotechnology platform company Drugging the Genome™ to address disease at the base level using a new class of precision genetic medicines, closed at $.86, but has traded up to $1.15, +33.72% in the aftermarket.  The 52-wk range is $.82-$5.45.
 
On May 17, Neubase announced the presentation of preclinical pharmacokinetics (PK) and biodistribution data for its lead development candidate, NT-0231.F, supporting a differentiated whole body treatment solution for myotonic dystrophy type 1 (DM1). These new data are being presented today in a poster session at the American Society of Gene and Cell Therapy (“ASGCT”) 25th Annual Meeting, taking place virtually and in person in Washington, D.C., May 16-19, 2022. Following a single intravenous (IV) injection of 30 mg/kg in wild-type BALB/c mice, NT-0231.F was cleared rapidly from the systemic compartment and demonstrated rapid and wide distribution into tibialis anterior muscle, heart muscle, and brain tissues. NT-0231.F rapidly cleared the plasma, and each tissue evaluated displayed an extended elimination phase with tissue concentrations measurable for at least four weeks following a single IV dose administration. Sandra Rojas-Caro, M.D., Chief Medical Officer of NeuBase, said, “We continue to build a robust and compelling data set potentially supporting a whole body treatment solution for DM1. These PK and biodistribution data presented today show IV administration of our lead candidate results in exposure in the major tissues that are affected by DM1. We believe the ability of our drug candidate to reach skeletal and heart muscles as well as brain tissue may potentially deliver a differentiated therapeutic approach to not only treat the myotonia, muscle weakness, and cardiac effects but also the cognitive impairments seen in DM1. We have now demonstrated in preclinical models that our lead candidate NT-0231.F achieves clinically relevant molecular and functional rescue as well as whole-body distribution.”

Economic Reports

On Tuesday, the existing home sales report confirmed a 3.4% M/M drop in May to a seasonally adjusted annual rate of 5.41M. Total sales in April also dropped significantly by 8.6% compared to a year ago.

On Wednesday, the Weekly Mortgage Applications Index report showed a 4% rise.

Investing & Inspiration

  1. “Our chief want is someone who will inspire us to be what we know we could be.” – Ralph Waldo Emerson

  2. “Patience is a virtue, and I’m learning patience. It’s a tough lesson.” – Elon Musk

  3. “Great things are done when men and mountains meet.” – William Blake

  4. “The man who has no imagination has no wings.” – Muhammad Ali

  5. “Formula for success: rise early, work hard, strike oil.” – J. Paul Getty

  6. “Action is the foundational key to all success.” – Pablo Picasso

  7. “Hope is like the sun, which, as we journey toward it, casts the shadow of our burden behind us.” – Samuel Smiles

    “The backbone of surprise is fusing speed with secrecy.” – Carl von Clausewitz

  8. “There are no shortcuts in evolution.” – Louis D. Brandeis

  9. “I am fascinated by what is beautiful, strong, healthy, what is living. I seek harmony.” – Leni Riefenstahl
  10. “If one advances confidently in the direction of his dreams, and endeavors to live the life which he has imagined, he will meet with a success unexpected in common hours.” – Henry David Thoreau
  11. “Waste no more time arguing about what a good man should be. Be one.” – Marcus Aurelius
  12. “It is during our darkest moments that we must focus to see the light.” – Aristotle Onassis
  13. “Courage is fear holding on a minute longer.” – George S. Patton
  14. “You must be the change you wish to see in the world.” – Mahatma Gandhi
  15. “Don’t judge each day by the harvest you reap but by the seeds that you plant.” – Robert Louis Stevenson 
  16. “It is in the character of very few men to honor without envy a friend who has prospered.” – Aeschylus
  17. “Life is a series of natural and spontaneous changes. Don’t resist them – that only creates sorrow. Let reality be reality. Let things flow naturally forward in whatever way they like.” – Lao Tzu
  18. “The more you praise and celebrate your life, the more there is in life to celebrate.” – Oprah Winfrey
  19. “Anything simple always interests me.” – David Hockney
  20. “He who angers you conquers you.” – Elizabeth Kenny
  21. “Concision in style, precision in thought, decision in life.” – Victor Hugo
  22. “The secret of genius is to carry the spirit of the child into old age, which means never losing your enthusiasm.” – Aldous Huxley
  23. “View health as an investment, not an expense.” – John Quelch
  24. “The most effective way to do it, is to do it.” – Amelia Earhart
  25. “Man needs his difficulties because they are necessary to enjoy success.” – A. P. J. Abdul Kalam
  26. “Do not dwell in the past, do not dream of the future, concentrate the mind on the present moment.” – Buddha
  27. “Nobody made a greater mistake than he who did nothing because he could do only a little.” – Edmund Burke
  28. “You must do the things you think you cannot do.”- Eleanor Roosevelt
  29. “Success is dependent on effort.” – Sophocles
  30. “Nobody who ever gave his best regretted it.” – George Halas
  31. “Lots of people want to ride with you in the limo, but what you want is someone who will take the bus with you when the limo breaks down.” ~ Oprah Winfrey
  32. “And when I breathed, my breath was lightning.” – Black Elk
  33. “Moderation is the silken string running through the pearl chain of all virtues.” – Joseph Hall
  34. “You are the sum total of everything you’ve ever seen, heard, eaten, smelled, been told, forgot – it’s all there. Everything influences each of us, and because of that I try to make sure that my experiences are positive.” – Maya Angelou
  35. “If you want a guarantee, buy a toaster.” – Clint Eastwood
  36. “We are an impossibility in an impossible universe.” – Ray Bradbury
  37. “If you think in terms of a year, plant a seed; if in terms of ten years, plant trees; if in terms of 100 years, teach the people.” – Confucius
  38. “I’d rather attempt to do something great and fail than to attempt to do nothing and succeed.” – Robert H. Schuller
  39. Do your little bit of good where you are; it’s those little bits of good put together that overwhelm the world.” Desmond Tutu
  40. “It takes considerable knowledge just to realize the extent of your own ignorance.” – Thomas Sowell
  41. “Do not dwell in the past, do not dream of the future, concentrate the mind on the present moment.” – Buddha”
  42. Surprise is the greatest gift which life can grant us.” –  Boris Pasternak
  43. “Trust in dreams, for in them is hidden the gate to eternity.” – Khalil Gibran 
  44. “Always be yourself, express yourself, have faith in yourself, do not go out and look for a successful personality and duplicate it.” – Bruce Lee
  45. “All life is an experiment. The more experiments you make the better.” – Ralph Waldo Emerson
  46. “There are no secrets to success. It is the result of preparation, hard work, and learning from failure.” –  Colin Powell
  47. “There is more to life than increasing its speed.” – Mahatma Gandhi
  48. “Your attitude is like a box of crayons that color your world. Constantly color your picture gray, and your picture will always be bleak. Try adding some bright colors to the picture by including humor, and your picture begins to lighten up.” – Allen Klein
  49. “Definiteness of purpose is the starting point of all achievement.” – W. Clement Stone
  50. “Success usually comes to those who are too busy to be looking for it.” – Henry David Thoreau
  51. “In matters of truth and justice, there is no difference between large and small problems, for issues concerning the treatment of people are all the same.” – Albert Einstein
  52. “Life is too short for long-term grudges.” – Elon Musk
  53. There cannot be a crisis next week. My schedule is already full.” – Henry Kissinger
  54. “Success consists of getting up just one more time than you fall.” – Oliver Goldsmith
  55. “The Earth is the cradle of humanity, but mankind cannot stay in the cradle forever.” – Konstantin Tsiolkovsky
  56. “Ours is a world of nuclear giants and ethical infants. We know more about war that we know about peace, more about killing that we know about living.” – Omar N. Bradley
  57. “Beauty surrounds us, but usually we need to be walking in a garden to know it.” – Rumi
  58. “But man is not made for defeat. A man can be destroyed but not defeated.” – Ernest Hemingway
  59. “Don’t watch the clock; do what it does. Keep going.” – Sam Levenson
  60. “Let there be work, bread, water and salt for all.” – Nelson Mandela
  61. “The social object of skilled investment should be to defeat the dark forces of time and ignorance which envelope our future.” – John Maynard Keynes
  62. “A successful society is characterized by a rising living standard for its population, increasing investment in factories and basic infrastructure, and the generation of additional surplus, which is invested in generating new discoveries in science and technology.” – Robert Trout
  63. “I know not with what weapons World War III will be fought, but World War IV will be fought with sticks and stones.” – Albert Einstein
  64. “It is the fight alone that pleases us, not the victory.” – Blaise Pascal
  65. “If you can’t describe what you are doing as a process, you don’t know what you’re doing.” – W. Edwards Deming
  66. “Never interrupt your enemy when he is making a mistake.” – Napoleon Bonaparte
  67. “Be sure you put your feet in the right place, then stand firm.” – Abraham Lincoln
  68. “Without investment there will not be growth, and without growth there will not be employment.” – Muhtar Kent
  69. “You have to do your own growing no matter how tall your grandfather was.” – Abraham Lincoln
  70. “Victory has a thousand fathers, but defeat is an orphan.” – John F. Kennedy
  71. “Delete the negative; accentuate the positive!” – Donna Karan
  72. “It’s crazy how fast time flies and how things progress.” – Nathan Chen
  73. “The world is a dangerous place to live; not because of the people who are evil, but because of the people who don’t do anything about it.” – Albert Einstein
  74. “Life isn’t about finding yourself. Life is about creating yourself.” – George Bernard Shaw
  75. “Everything has beauty, but not everyone sees it.” – Confucius
  76. A man must be big enough to admit his mistakes, smart enough to profit from them, and strong enough to correct them.” – John C. Maxwell
  77. “Walking with a friend in the dark is better than walking alone in the light.” – Helen Keller
  78. “A man who dares to waste one hour of time has not discovered the value of life.” – Charles Darwin
  79. “The greater danger for most of us lies not in setting our aim too high and falling short; but in setting our aim too low, and achieving our mark.” – Michelangelo
  80. “Progress is man’s ability to complicate simplicity.” – Thor Heyerdahl
  81. “I like to encourage people to realize that any action is a good action if it’s proactive and there is positive intent behind it.” – Michael J. Fox
  82. “Nothing is impossible, the word itself says ‘I’m possible’!” – Audrey Hepburn
  83. “But investment in space stimulates society, it stimulates it economically, it stimulates it intellectually, and it gives us all passion.” – Bill Nye
  84. “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
  85. “Life is a tragedy when seen in close-up, but a comedy in long-shot.” – Charlie Chaplin
  86. “No matter what you’re going through, there’s a light at the end of the tunnel and it may seem hard to get to it but you can do it and just keep working towards it and you’ll find the positive side of things.” – Demi Lovato
  87. “Infrastructure investment in science is an investment in jobs, in health, in economic growth and environmental solutions.” – Oren Etzioni
  88. “Educating our children and giving them the skills they need to compete in a global economy is a smart investment in our country’s future.” – Sheldon Whitehouse
  89. “Know thy self, know thy enemy. A thousand battles, a thousand victories.” – Sun Tzu
  90. “If one does not know to which port one is sailing, no wind is favorable.” – Lucius Annaeus Seneca
  91. “Beware of missing chances; otherwise it may be altogether too late some day.” – Franz Liszt
  92. “The sofa is a really important investment for anybody, and I don’t mean financially. You need to find a really great sofa that can transition with you, and you can build from there.” – Jeremiah Brent
  93. “There is no investment you can make which will pay you so well as the effort to scatter sunshine and good cheer through your establishment.” – Orison Swett Marden
  94. “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
  95. “There is little that can withstand a man who can conquer himself.” – Louis XIV
  96. “In tennis, you strike a ball just after the rebound for the fastest return. It’s the same with investment.” – Masayoshi Son
  97. “A camel makes an elephant feel like a jet plane.” – Jackie Kennedy
  98. “The advance of technology is based on making it fit in so that you don’t really even notice it, so it’s part of everyday life.” – Bill Gates
  99. “Success depends upon previous preparation, and without such preparation there is sure to be failure.” – Confucius, Chinese 
  100. “Coming together is a beginning; keeping together is progress; working together is success.” – Edward Everett Hale
  101. “Never do anything against conscience even if the state demands it.”– Albert Einstein
  102. “Education is not only a ladder of opportunity, but it is also an investment in our future.” – Ed Markey
  103. “The true measure of a man is how he treats someone who can do him absolutely no good.” – Samuel Johnson
  104. “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
  105. “A successful society is characterized by a rising living standard for its population, increasing investment in factories and basic infrastructure, and the generation of additional surplus, which is invested in generating new discoveries in science and technology.” – Robert Trout
  106. “The best preparation for tomorrow is doing your best today.” – H. Jackson Brown, Jr.
  107. “Friendship marks a life even more deeply than love. Love risks degenerating into obsession, friendship is never anything but sharing.” – Elie Wiesel
  108. “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
  109. “Success isn’t measured by money or power or social rank. Success is measured by your discipline and inner peace.” – Mike Ditka
  110. “No matter how many goals you have achieved, you must set your sights on a higher one.” – Jessica Savitch 
  111. “Start where you are. Use what you have. Do what you can.”– Arthur Ashe
  112. “The secret of getting ahead is getting started.” – Mark Twain
  113. “The amount of work and the amount of both physical and emotional investment it takes to get to the top.” – Drew Bledsoe
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