Stocks Drop As Interest Rates & Fears Pop This Week – $AAPL $ADIL $GOOG $INDP $LPTX $RENT $SIL $TSLA $VIX Rise!
Happy Saturday!
I hope you all had a marvelous week and that you are out and about enjoying a wonderful spring weekend.
As for the broad stock market, equities overall closed significantly lower again this week and volatility rose considerably as the belief that an interest rate cut or two in ’24 was in the picture became less certain. China also added global growth concerns and the threat of war in the Middle East persisted. The CBOE Volatility Index (^VIX) climbed significantly for the second consecutive week over the course of the week up 13.96% to close at $17.31.
Continuing to fuel fears, at least in part, the US macroeconomic schedule offered a number of reports including on Tuesday, the March NFIB Small Business Optimism Index report that came in slightly lower at 88.5. On Wednesday, the schedule provided the March CPI reports that came in at .4%/higher than expected, & also delivered the Weekly MBA Mortgage Applications Index report that came higher at .1% & the February Wholesale Inventories report clocked in higher at .5%. Essentially, services prices remain a problem as large increases in medical costs & insurance premiums are playing a significant a role. On Thursday, the PPI reports came in lower than expected as the March PPI landed at .2% & the March Core PPI also came in at .2%, while the Total PPI still edged up to 2.1%.. The Weekly Initial Claims report came in lower at 211k, while the Weekly Continuing Claims report clocked in higher at 1.817M. On Friday, the March Import Prices came in higher at .4%, while the March Import Prices sans oil came at .1%. The March Export Prices came in at .3% & the March Export Prices sans agriculture came in at .4%. The preliminary April University of Michigan Index of Consumer Sentiment report clocked in lower than expected at 77.9.
In turn, the yield curve rose considerably again this week as the 10-yr note yield rose 17bps to 4.50% & the 2-yr note yield moved up 16bps to 4.88%. Interestingly, Oil prices also pulled back to close at $85.51/bbl, -1.6%, but remain up 19.3% YTD as supply issue concerns continue & some say that we are headed towards $95/bbl soon and we are paying nearly %6.50/gallon at the pump. The U.S. Dollar Index also moved significantly higher from 104.29 to 106.01.
The 10-yr note yield jumped 12 basis points to 4.50% and the 2-yr note yield, which is most sensitive to changes in the fed funds futures rate, jumped 15 basis points to 4.88%.
At the end of the week, the Dow 30 closed at 37,983 (-2.4%) this week and is now up just .8% YTD. The S&P 500 closed at 5,123 (-1.6%) and now up 7.4% YTD will 11 of the 11 sector closed in the red led by a 3.6% drop in the financials & the materials sectors and a 3.1% drop in the real estate & the healthcare sectors. The Nasdaq closed at 16,175 (-.5%) and is now up 7.8% YTD. The overweighted Magnificent Seven closed as follows over the last 5-days: Alphabet (GOOG) closing at $159.19, +3.41%, Amazon (AMZN) closing at $186.13, +.57%, Apple (AAPL) at $176.55, +4.11%, Meta Platforms (META) closing at 511.90, -2.93%, Microsoft (MSFT) closing at $421.90, -.85%, NVIDIA (NVDA) closing at $881.86, +.20%, & Tesla (TSLA) closing at $171.05, +3.73%.
The small caps on the Russell 2000 closed at 2,003.17 (-2.92%) for the week & is now down -1.81% YTD, while the MicroCaps closed lower this week as the iShares Micro-Cap ETF (IWC) closed at $114.37, -2.95% over the week.
Bank stocks on The SPDR S&P Regional Banking ETF (KRE) moved down to close at $46.52, -3.51% over the last 5-days & the SPDR S&P Bank ETF (KBE) moved down over the last 5-days to close at $43.79, -3.48% this week. On Friday, JPMorgan Chase (JPM, $182.79, -6.5%) CEO Jamie Dimon confirmed that they left the bank’s net interest income guidance for 2024 in place, but also offered some macroeconomic cautionary commentary, while other major banks Citigroup (C, $59.68, -1.7%) & Wells Fargo (WFC 56.47, -.4%) after they missed the street’s expectations.
Overall, The Nasdaq Biotechnology ETF (IBB) closed at $129.58, -2.08%, the NYSE ARCA Biotech Index (^BTK) closed at 5,065.66, -2.37% & the SPDR S&P Biotech ETF (XBI) closed at $88.15, -2.25% over the last 5-days. The iShares U.S. Healthcare ETF (IYH) closed at $58.40, -2.83% over the last 5-days. Upsetting the healthcare applecart recently, it was reported that Medicare Advantage plans for 2024-2025 period will remain the same at 3.70%.
Cathie Wood’s ARK Innovation ETF (ARKK) closed at $46.51, -1.29% over the last 5-days.
From the world of cryptocurrency, Bitcoin (BTC) moved to 67,003.54, -6.43% over the course of the last 5-days at the time of the completion of this message.
Gold prices closed at $2,342 up from $2,328 over the last 5-days. The SPDR Gold Shares (GLD) closed at $216.89, +.81% over the past 5-days and is up 14.54% over the last year. Silver prices closed at $28 up from $27.46/oz. The Global X Silver ETF (SIL) closed at 31.46, +1.32% over the last 5-days.
VP Watchlist Updates
Rent the Runway Inc. (RENT), the world’s first and largest shared designer closet platform, jumped +302.30% over the last 5-days to close at $19.23 after beating investor expectations and giving its optimistic view of its ability to make a turnaround.
Leap Therapeutics, Inc. (Nasdaq: LPTX, $3.24, +27.56% over the last 5-days), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, on April 11 announced it has entered into a securities purchase agreement with a select group of institutional investors to issue and sell an aggregate of 12,660,993 shares of its common stock (“Common Stock”) at a price of $2.82 per share and pre-funded warrants to purchase 1,523,404 shares of Common Stock at a price of $2.819 per share of Common Stock issuable upon exercise of the pre-funded warrants, in a private placement. Leap anticipates the gross proceeds from the private placement will be approximately $40 million, before deducting any offering-related expenses. The financing is expected to close on April 15, 2024, subject to satisfaction of customary closing conditions. The private placement investors included new and existing investors, including Gilead Sciences, Inc., a life sciences-focused investor, Samsara BioCapital, 683 Capital Partners, LP, Laurion Capital Management, and Rock Springs Capital.J.P. Morgan acted as the exclusive placement agent for the transaction.
Adial Pharmaceuticals, Inc. (NASDAQ: ADIL, $2.33, up +100.86% over the last 5-days), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, announced on April 10 the publication of a peer-reviewed article highlighting the promising clinical results, strong safety profile and high compliance among patients administered AD04 (low-dose ondansetron), the Company’s lead investigational new drug product being developed for the treatment of Alcohol Use Disorder (AUD). The publication also reported the results of a new study analyzing the liver safety profile of AD04 compared with placebo in subjects with AUD in the Company’s prior Phase 3 clinical trial.
On Feb. 21, Modular Medical announced the closing of its previously announced underwritten public offering (the “offering”) of 9,090,910 shares of its common stock, led by Manchester Explorer, L.P., which is managed by Jeb Besser, Modular Medical’s Chief Executive Officer, and Morgan Frank, a member of the Company’s board of directors, and other existing institutional investors. Each share of common stock was sold at a price to the public of $1.10 per share. The gross proceeds to Modular Medical from this offering were approximately $10 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company. The Company intends to use the net proceeds from the offering to fund operations and for working capital and general corporate purposes, including capital expenditures. In addition, Modular Medical has granted the underwriters a 30-day option to purchase up to an additional 1,321,989 shares of common stock to cover over-allotments, if any.Titan Partners Group, a division of American Capital Partners, acted as sole book-running manager for the offering.
Lantern (LTRN) closed at $6.39, up +49.30% YTD. Lantern is an Artificial Intelligence (AI) firm that is transforming the cost, pace, and timeline of oncology drug discovery and development and specifically is developing targeted and transformative cancer therapies using its proprietary RADR® AI and machine learning (“ML”) platform with multiple clinical stage drug programs.
On March 18 after the close, Lantern announced operational highlights and financial results for the fourth quarter and fiscal year ended December 31, 2023. Panna Sharma, President and CEO of Lantern Pharma started, “This past quarter and the entire year of 2023 was a period of meaningful and remarkable progress for our programs and our AI platform at Lantern Pharma. Our team demonstrated how combining emerging AI technologies, cancer biology models and experiments, chemical, molecular, and multiomic biomarker data, along with large-scale patient data holds the promise of transforming timelines and costs in drug development for oncology. We are very enthusiastic about 2024 and will be actively focused on meeting and possibly exceeding the milestones ahead of us, which include potential initial data from our LP-184 Phase 1A trial; advancing the new company born from AI – Starlight Therapeutics, which is focused wholly on CNS cancers; and progressing our ADC oncology program. Computational and AI-driven approaches are increasing their value-driving impact on oncology drug development, and our team continues to increase the capabilities and usefulness of our platform while also helping to de-risk and sharpen the focus of our existing clinical drug candidates. Our leadership in the innovative use of AI and machine learning to transform costs and timelines in the development of precision oncology therapies has guided three drug development programs in active clinical trials. We believe this pace of development with our focused team and resources should yield significant future benefits for investors and patients as our industry matures, adopts and accepts a data and AI-centric approach to drug development.”
On March 15, Lantern announced the dosing of the first two patients in the Phase 1 clinical trial evaluating Lantern’s investigational new drug LP-284 in patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL), including mantle cell lymphoma (MCL) and double hit lymphoma (DHL) and other high-grade B-cell lymphomas (HGBL) as well as other select solid tumors and sarcomas. Recently, Lantern Pharma’s AI platform, RADR® is expected to exceed 100 billion data points during 2024, and has been crucial in uncovering and accelerating indications for LP-284 as well as other drug-candidates that are in development.
Watch “How AI Has Lit A Revolution In Healthcare, Medicine, & Human Longevity” on The Tribe Public Channel as Panna Sharma CEO Lantern Pharma was interviewed on Feb. 29.
On Feb. 15, Lantern announced an important milestone in its antibody-drug conjugate (ADC) program. In collaboration with Bielefeld University, Lantern has generated a new class of highly specific and highly potent ADCs with a cryptophycin drug-payload. This novel approach utilizes cysteine-engineered antibodies which allows for the development of uniform and homogenous ADCs with precise control of the drug to antibody ratio (DAR). The drug-payload, cryptophycin, has the potential to improve upon existing ADCs used in the clinical setting by: 1) improving the anti-tumor potency of the ADC molecule, and 2) overcoming drug resistance tumors can frequently develop to existing drug-payloads such as MMAE (Monomethyl auristatin E). The cryptophycin drug-payload and cryptophycin-ADC (CpADC) averaged an 80% cancer cell kill rate across the tested cancer cell lines and significantly outperformed MMAE. In a broad range of preclinical studies, the cryptophycin-ADC (Cp-ADC) demonstrated promising picomolar level potency and anti-tumor activity in a wide range of solid tumors, including six cancer indications that are being further evaluated. These six indications include: breast, bladder, colorectal, gastric, pancreatic and ovarian cancer. Initial results (Figure 1) have also shown that in high Her2 expressing tumors, Cp-ADC with a DAR of 8 (Tras(C8)-Cp) and DAR of 4 (Tras(C4)-Cp) is more potent than an MMAE ADC with a DAR of 8. MMAE payloads are used in several commercially available anti-cancer ADCs, including Adcetris®, Polivy® and Enhertu®. Additionally, the Cp-ADC with a lower DAR (Tras(C2)-Cp) provides an equivalent tumor kill-rate to that of an MMAE-ADC with a DAR of 8. In a moderate Her2 expressing cell line, the Cp-ADC with a DAR of 8 (Tras(C8)-Cp) was about 10 times more potent than a DAR 8 MMAE-ADC. The newly developed Cp-ADC showed highly efficient anti-tumor activity in all six cancer cell lines with EC-50 values in the picomolar to single-digit nanomolar range. Additional studies are now being developed to further validate and expand these findings and to obtain a better understanding of the genomic and biomarker correlates of payload efficacy across these tumors.
Kishor Bhatia, Ph.D., Lantern’s Chief Scientific Officer commented, “Our strategic, data-driven approach of utilizing cryptophycin as a highly potent and novel payload alongside the prioritization of biologically novel and relevant targets with scalable and efficient drug conjugate formats will help expand the repertoire and diversity of ADC opportunities.”
Lantern is also utilizing its AI platform, RADR® to further refine and understand other cancer targets, with a focus on prioritizing targets that are expressed across multiple tumor types or subtypes and have few or no therapeutic ADC options. Given the promise of cryptophycin as a payload, Lantern is also focused on the development and testing of two other cryptophycin-ADC molecules. For these selected targets, Lantern is in advanced discussions with potential partners and collaborators with the goal of generating proof-of-concept data for these additional ADCs and potentially other novel drug conjugate formats. Lantern expects to provide additional details on these studies and collaborations in the coming quarters. These efforts aim to improve ADC development for specific patient populations and potentially guide more effective future clinical treatments with less cost and greater efficiency than historical ADC drug development.
On Jan. 17, Starlight Therapeutics— a Lantern Pharma (Nasdaq: LTRN) subsidiary focused exclusively on the clinical development of therapies for central nervous system and brain cancers with limited or no effective therapeutic options— announced that Marc Chamberlain, M.D. has joined Starlight as its Chief Medical Officer. Dr. Chamberlain will oversee Starlight’s clinical operations, which currently include planned clinical trials for glioblastoma and other high-grade gliomas, brain metastases in adults, and atypical teratoid rhabdoid tumors (ATRT), and diffuse pontine glioma (DIPG) in children. In his role, Dr. Chamberlain will apply his significant medical, clinical, and pharmaceutical development expertise to advance Starlight’s AI-enabled and accelerated drug development portfolio. Dr. Chamberlain is a leading medical oncologist with an extensive and distinct background in therapeutic development, clinical practice, and academic research with a focus in adult and pediatric neurology and neuro-oncology. His experience before joining Starlight has included serving as the co-director of the neuro-oncology programs at 4 NCI designated cancer centers— Moores Cancer Center at UC San Diego, Norris Cancer Center at USC, Moffit Cancer Center at the University of South Florida, and Fred Hutchinson Cancer Center at the University of Washington. He has also served as medical director for Cascadian Therapeutics, Seattle Genetics, SystImmune, Angiochem, and Pionyr Immunotherapeutics. Dr. Chamberlain has published more than 300 neurology-focused papers in peer-reviewed journals. “Starlight Therapeutics and Lantern Pharma are poised to transform oncology with AI-enabled drug development aimed at providing advanced precision therapeutics for cancers in areas of severely unmet need, such as multiple types of pediatric and adult brain cancers, for which there is currently no cure,”said Panna Sharma, CEO and President of Lantern Pharma. “Dr. Chamberlain’s insight and expertise in neuro-oncology and therapeutic development will be invaluable to the further development of treatments already in the pipeline, and the discovery and development of new future treatments that are so desperately needed by cancer patients, especially in neuro-oncology.” Dr. Chamberlain earned his medical degree at the Columbia University College of Physicians and Surgeons, followed by pediatric and neurology residencies at the University of California, Los Angeles, and a neuro-oncology fellowship at the University of California, San Francisco. “Starlight, in collaboration with Lantern Pharma, is poised to advance its novel central nervous system (CNS) penetrant wholly synthetic acylfulvene, LP-184 (referred to as “STAR-001″ for CNS indications), to target tumors in the brain. We are now preparing for two recurrent glioblastoma studies as part of a larger planned expansion study to assess STAR-001 in subjects who have failed standard-of-care temozolomide and involved field radiotherapy. The development of STAR-001 for use in brain tumors has utilized Lantern’s proprietary RADR® platform of in silico modeling as well as extensive preclinical experimentation in multiple in-vitro and in-vivo models,” said Dr. Chamberlain. “I’m looking forward to working alongside the talented researchers and experts at Lantern and its collaborators at Starlight who have already done so much to advance these treatments. I look forward to working together with our collaborators and clinicians to bring these and many more innovative neuro-oncology treatments to the patients who need them.” Formed in Q1 of 2023, Starlight Therapeutics is leveraging RADR®— Lantern Pharma’s proprietary artificial intelligence and machine learning platform focused on transforming the cost, pace and timeline of oncology drug discovery and development— to research, develop and clinically advance therapeutics for CNS and brain cancers.
Deckers Brands (NYSE: DECK, $814.37, +77.90% over the last year) is a global leader in designing, marketing, and distributing innovative footwear, apparel, and accessories.
On Feb. 12, Deckers announced that it has named Robin Green as its next President of HOKA, effective immediately. Green will serve on the Executive Leadership Team, reporting directly to Dave Powers, Chief Executive Officer and President of Deckers Brands. Green has an extensive track record of leading and operating complex global businesses while delivering transformative results and brand growth, most recently as Global Vice President of Men’s Running and Fitness for NIKE, Inc. She will lead Deckers’ HOKA brand, with a focus on delivering continued growth, further expanding on consumer and athlete connection, and accelerating the product innovation pipeline across a dynamic global marketplace.
Shares of Indaptus Therapeutics, Inc. (Nasdaq: INDP), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, closed at $2.77, +13.52% over the last 5-days & =57.39% YTD.
Indaptus’ CEO, Jeffrey Meckler presented a corporate overview at the MedInvest Biotech & Pharma Investor Conference. The conference is being held on April 3 – 4, 2024 at Cooley Law, 55 Hudson Yards, New York, NY 10001.
On April 11, Indaptus announced it was proud to unveil its poster at the 2024 Annual Meeting of the American Association for Cancer Research (AACR) in San Diego on Wednesday, April 10th. The poster details mechanism of action data that demonstrates the Company’s Decoy platform successfully induces, matures or activates multiple immune cell types involved in anti-tumor responses. The latest findings significantly enhance the Company’s understanding of its “Decoy” platform technology, which uses killed, non-pathogenic bacteria engineered to activate the immune system to attack tumors. The study highlights the platform’s effectiveness in engaging key innate and adaptive immune cells, including, natural killer cells, natural killer T cells, dendritic cells, CD4+, and CD8+ T cells. In some settings, the platform also produced additive or synergistic activity in combination with IL-2, an approved cancer drug. Additionally, the data reveal that the Decoy platform may not only boost the immune system’s ability to recognize and kill tumor cells, but potentially also overcome a mechanism that suppresses the immune response. The results suggest that the Company’s Decoy bacteria can both directly and indirectly prime the immune system to more effectively fight cancer. Jeffrey Meckler, Indaptus’ Chief Executive Officer, added, “We are encouraged by the promising results observed in our preclinical studies and our ongoing Phase 1 clinical trial. The recognition and validation from prestigious organizations such as the AACR, coupled with the support and insights we are receiving from medical experts, partners and investors at the conference, inspire us to continue advancing our technology and demonstrating its significant therapeutic potential for the treatment of solid tumors.” The full poster can be accessed on the Indaptus Therapeutics website by clicking here.
Dr. Michael Newman, Indaptus’ Founder, Chief Scientific Officer, and lead author, commented, “The new data are consistent with our preclinical animal tumor model studies and provide evidence for our hypothesis that patented Decoy bacteria can activate a wide range of innate and adaptive human immune cells involved in fighting tumors. This aligns with what we’ve observed in our ongoing Phase 1 clinical trial of Decoy20 – broad immune activation, as evidenced by transiently increased levels of many key cytokines and chemokines following single dose administration. These findings bolster our confidence in Decoy20’s potential as a multifaceted immunotherapy.”
Indaptus CEO presented in an open Q&A on Tribe Public’s Webinar titled, “Fully Engaging The Human Immune System To Cure Disease” on Wednesday, March 20, 2024. You can now watch the event video at the Tribe Public YouTube Channel at this link.
On March 13, Indaptus announced financial results for the fourth quarter and fiscal year ended December 31, 2023 and provided a corporate update. Jeffrey Meckler, Chief Executive Officer of Indaptus, commented, “We are thrilled with the progress we made in 2023, which was capped off in November when we announced that our lead candidate, Decoy20, demonstrated a broad immune response in patients following a single dose in the first cohort of our ongoing phase 1 study. More recently, in March 2024, we announced positive results from our second cohort. In close consultation with an independent Safety Review Committee, we are now initiating a multi-dose cohort. Our objective in this next part of the Phase 1 trial is to determine the safety of Decoy20, with multiple doses administered to the same patient, which we believe could also potentially enhance anti-tumor activity across various tumor types. As we are encouraged by these initial findings and by the anti-cancer activity we observed from multi-dosing in our pre-clinical models, we look forward to continuing our efforts to demonstrate safety and efficacy. We remain prudent in managing our cash position and furthering our research in a cost effective and efficient manner.”
Indaptus’ CEO Jeffrey A. Meckler, and Nir Sassi, Chief Financial Officer, presented a corporate update at the 2024 BIO CEO & Investor Conference. The conference is being held on February 26 – 27, 2024 at the New York Marriott Marquis.
On Jan. 4, Indaptus announced that the European Patent Office (EPO) has informed the company that it will grant a European patent related to the company’s platform technology, covering a composition that can be used in the prevention or treatment of viral infections. The patent, titled “Methods of Treatment of Infections Using Bacteria,” (Application 19 866 580.4) provides protections for the application of the Company’s Decoy technology platform alone or in combination with standards of care for the prevention or treatment of any viral infection. The EPO patent will be the second patent granted to Indaptus outside the United States for this application. Jeffrey Meckler, Indaptus Therapeutics CEO, commented, “The continued protection of our intellectual property both in the U.S. and abroad will provide a competitive advantage for the Company, which should ultimately drive significant shareholder value over time. We continue to explore the applications of our technology platform beyond solid tumors, for which we are currently engaged in a Phase 1 clinical trial, and look forward to updating our shareholders on scientific progress.”
Shares of ADT Inc. (ADT), the most trusted brand in smart home and small business security, closed at $6.36, -1.09% over the last 5-days.
On March 6, ADT announced the pricing of a secondary public offering of 65,000,000 shares of the Company’s common stock held by certain entities managed by affiliates of Apollo Global Management, Inc. (the “Selling Stockholders”) at a price to the public of $6.50 per share. The offering is expected to close on March 11, 2024, subject to satisfaction of customary conditions.The underwriters will have a 30-day option to purchase up to an additional 9,750,000 shares of common stock from the Selling Stockholders. The Company is not selling any shares and will not receive any proceeds from the offering. In addition, ADT has authorized the concurrent purchase from the underwriters of 15,000,000 shares of common stock as part of the secondary public offering (the “Share Repurchase”) subject to the completion of the offering. The Share Repurchase is part of the Company’s existing $350 million share repurchase program. The underwriters will not receive any underwriting fees for the shares being repurchased by the Company. Morgan Stanley, Barclays, Apollo Global Securities and RBC Capital Markets are acting as book-running managers for the offering. BNP PARIBAS, Deutsche Bank Securities, Mizuho, Goldman Sachs & Co. LLC, MUFG, BMO Capital Markets, BTIG and Raymond James are acting as joint book-runners for the offering. Berenberg, Fifth Third Securities, Academy Securities, Bancroft Capital and Siebert Williams Shank are acting as co-managers for the offering.
Shares of Seanergy Maritime Holdings Corp. (SHIP), the only pure-play Capesize ship-owner publicly listed in the U.S. closed at $8.24, -5.29% over last 5-days. Seanergy is known as a leading player in the global shipping industry, being the only pure-play Capesize ship owner publicly listed in the U.S. The company specializes in Capesize shipping, representing the largest dry bulk carriers globally. Seanergy’s operating fleet currently consists of 17 vessels (1 Newcastlemax and 16 Capesize), with an average age of approximately 12.7 years and an aggregate cargo-carrying capacity of approximately 3,054,820 deadweight tons (dwt). The company is incorporated in the Marshall Islands and has executive offices in Glyfada, Greece.
On March 15, Seanergy announced its financial results for the fourth quarter and twelve months ended December 31, 2023. The Company also declared a regular quarterly cash dividend of $0.025 per common share and a special cash dividend of $0.075 per common share for the fourth quarter of 2023.
On Dec. 14, Seanergy announced that the Board of Directors of the Company (“BOD”) has authorized a new $25 million buyback program (the “Plan”) which can be utilized to repurchase the Company’s common shares and other securities. The Company will also fully repay its last remaining convertible note (the “Note”) pursuant to the terms of the Note. The Note bears a 5.5% coupon, it is the last from a series of convertible notes with aggregate original notional amount of $38.7 million and $3.2 million face value remains outstanding. The full repayment of the Note will preempt potential dilution upon conversion of the Note.
On Jan, 23, NAYA Biosciences Inc. (“NAYA”), a company which has recently signed a definitive merger agreement with INVO Bioscience (INVO, $.8150) to establish an expanded, publicly-traded life science company dedicated to increasing patient access to breakthrough treatments in oncology, regenerative medicine, and fertility, today announced that it has entered into a binding letter of intent to acquire Florida Biotechnologies, Inc. a gene therapy company focusing on the treatment of mitochondrial diseases.announced that it has entered into a binding letter of intent to acquire Florida Biotechnologies, Inc. a gene therapy company focusing on the treatment of mitochondrial diseases. “We are delighted to contribute to the emergence of a strong biotech ecosystem leveraging Florida’s academic medical excellence,” commented Florida Biotechnologies cofounder Dr. Peter Kash. “The NAYA leadership team brings an agile entrepreneurial platform, broad development and commercialization experience, and access to public capital, which will unlock the potential of our promising AAV gene therapy platform for mitochondrial genetic diseases. As it expands its clinical pipeline to additional regenerative medicine as well as oncology and fertility programs, NAYA is poised to build a world-class Miami-based biopharmaceutical company.” “We are impressed by the initial safety and efficacy of the AAV gene therapy developed by Florida Biotechnologies and the University of Miami for the treatment of LHON, a rare and debilitating genetic disease with no currently approved therapeutic regimen,” commented NAYA Chairman & CEO Dr. Daniel Teper. “NAYA is committed to accelerating clinical development and Early Patient Access to this breakthrough therapy, which has the potential to achieve curative results in patients with progressive vision loss and blindness.”
On Jan 17, INVO Bioscience, announced that it has filed S-4 registration and preliminary joint proxy statements in connection with the upcoming merger. NAYA has also announced that five new board directors have joined its leadership team effective January 1st, 2024. The additions to the board join Chairman and Chief Executive Officer Dr. Daniel Teper, Vice Chairman Dr. Peter Kash, and Director Gilles Seydoux and will continue post-merger as part of the combined company alongside current INVO CEO Steve Shum. “NAYA is thrilled to welcome new board members with outstanding executive and entrepreneurial track records,” commented NAYA CEO Dr. Daniel Teper. “As we prepare for our merger with INVO, their experience will be key in helping the management team structure our group of companies and secure financing to advance our ambitious growth strategy for 2024 and beyond. Upon closing of the merger with INVO, the NAYA leadership team will focus on scaling up the fertility business through clinic acquisitions and revamped commercialization of INVOcell®, advancing the clinical development of our oncology assets, and building our regenerative medicine portfolio.”
New NAYA Board Members:
Laurent Audoly, PhD is an experienced R&D executive, CEO, and entrepreneur. He is currently executive partner at Apollo Health Ventures and was co-founder & CEO of multiple innovative biotechs, including Kymera Therapeutics (NASDAQ: KYMR), delivering on multi-billion dollar partnerships and scaling companies through multiple stages.
Lyn Falconio, is an accomplished consumer and healthcare marketing leader. She is currently Executive Engagement Lead at Publicis, the 2nd largest communications group in the world, where she launched multiple brands as Chief Marketing Officer.
Prakash Raman, PhD is a seasoned business development executive. He is currently President & CEO at Ribon Therapeutics and was previously Chief Business Development Officer at Flagship Pioneering and Global Head of Business Development at the Novartis Institute of Biomedical Research and Novartis Oncology.
Mark Rothera, MBA is an experienced commercial executive and serial public company CEO. He is currently President & CEO of Viracta Therapeutics (NASDAQ: VIRX) and was previously CEO at Silence Therapeutics (NASDAQ: SLN), Orchard Therapeutics (NASDAQ: ORTX), and Chief Commercial Officer at PTC Therapeutics.
Patrick Tricoli, PharmD, MBA is a an experienced biopharma executive and entrepreneur. He is currently CEO at Nanobiotix USA and Head of Global Business Development at Nanobiotix (NASDAQ: NBTX), where he helped close a multi-billion partnership with Johnson & Johnson. He previously held several leadership positions in corporate and business development and partnerships at Sanofi.
On Dec. 11 Naya announced that new data for its CD38-targeted Flex-NK™ Bispecific Antibody (NY-338, formerly CYT-338) for the treatment of Multiple Myeloma (MM) was published as an abstract in the 2023 American Society of Hematology’s (ASH) meeting supplement of Blood, in the “Multiple Myeloma: Prospective Therapeutic Trials” section. “NAYA is building a portfolio of differentiated clinical-stage oncology therapeutics, starting with two FLEX-NK™ bispecific antibodies acquired from Cytovia Therapeutics,” commented NAYA CEO Dr. Daniel Teper. “We are excited about this new data for our CD38-targeted antibody, which aims to address limitations with the current standard-of-care and offer new options for multiple myeloma patients.”
“The synergistic engagement of NK cells through NKp46 greatly enhances the immunotherapeutic effects of FLEX-NK™ bispecific antibodies, reducing NK cell fratricide, maintaining NK cell levels, and enhancing potency including reversal of NK cell dysfunction,” added Ola Landgren, MD, PhD, co-author of the abstract and Professor of Medicine, Chief of the Myeloma Division, and Leader of the Experimental Therapeutics Program at the University of Miami’s Sylvester Comprehensive Cancer Center. “The data supports initiation of clinical trials to evaluate this promising new therapy and makes it a potential best-in-class anti-CD38 therapeutic for multiple myeloma.”
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Investing & Inspiration
- “A leader is one who knows the way, goes the way, and shows the way.” – John C. Maxwell
- “They always say time changes things, but you actually have to change them yourself.” – Andy Warhol
- “The secret of happiness is something to do.” – John Burroughs
- “The world of reality has its limits; the world of imagination is boundless.”
- “You begin with the possibilities of the material.” – Robert Rauschenberg
- “The only Zen you can find on the tops of mountains is the Zen you bring up there.” – Robert M. Pirsig
- “Leadership is the capacity to translate vision into reality.” – Warren Bennis
- “A man should always consider how much he has more than he wants.” – Joseph Addison
- “Happiness is good health and a bad memory.” – Ingrid Bergman
- “We pass through this world but once.” – Stephen Jay Gould
- “Christmas waves a magic wand over this world, and behold, everything is softer and more beautiful.” – Norman Vincent Peale
- “Nothing can have value without being an object of utility.” – Karl Marx
- “Always turn a negative situation into a positive situation.” – Michael Jordan
- “Courage is found in unlikely places.” – J. R. R. Tolkien
- “One that would have the fruit must climb the tree.” – Thomas Fuller
- “Someone is sitting in the shade today because someone planted a tree a long time ago.” – Warren Buffett
- “We relish news of our heroes, forgetting that we are extraordinary to somebody too.” – Helen Hayes
- “A life spent making mistakes is not only more honorable, but more useful than a life spent doing nothing.” – George Bernard Shaw
- “Everything in the world may be endured except continual prosperity.” – Johann Wolfgang von Goethe
- “Nine-tenths of wisdom is being wise in time.” – Theodore Roosevelt
- “Time is money.” – Benjamin Franklin
- “Change before you have to.” – Jack Welch
- “Our deeds determine us, as much as we determine our deeds.” – George Eliot
- “The Universe is under no obligation to make sense to you.” – Neil deGrasse Tyson
- “Care and diligence bring luck.” – Thomas Fuller
- “Nobody made a greater mistake than he who did nothing because he could do only a little.” – Edmund Burke
- “A man who is a master of patience is master of everything else.” – George Savile
- “Once you replace negative thoughts with positive ones, you’ll start having positive results.” – Willie Nelson
- “Endurance is nobler than strength, and patience than beauty.” – John Ruskin
- “Act as if what you do makes a difference. It does.” – William James
- “Let us be grateful to people who make us happy, they are the charming gardeners who make our souls blossom.” – Marcel Proust
- “Strength and growth come only through continuous effort and struggle.” – Napoleon Hill
- “Science may never come up with a better office communication system than the coffee break.” – Earl Wilson
- “If everyone is moving forward together, then success takes care of itself.” – Henry Ford
- “Hope is like the sun, which, as we journey toward it, casts the shadow of our burden behind us.”– Samuel Smiles
- “Patriotism is supporting your country all the time, and your government when it deserves it.” – Mark Twain
- “What would life be if we had no courage to attempt anything?” – Vincent Van Gogh
- “The biggest risk is not taking any risk… In a world that is changing really quickly, the only strategy that is guaranteed to fail is not taking risks.” – Mark Zuckerberg
- “Our lives improve only when we take chances – and the first and most difficult risk we can take is to be honest with ourselves.” – Walter Anderson
- “Action is the foundational key to all success.” – Pablo Picasso
- “Success is never final, failure is never fatal. It’s courage that counts.” – John Wooden
- “Innovation distinguishes between a leader and a follower.” – Steve Jobs
- “All the art of living lies in a fine mingling of letting go and holding on.” – Havelock Ellis
- “The size of your success is measured by the strength of your desire; the size of your dream; and how you handle disappointment along the way.” – Robert Kiyosaki
- “O, wind, if winter comes, can spring be far behind?” – Percy Bysshe Shelley
- “Patience is a virtue, and I’m learning patience. It’s a tough lesson.” – Elon Musk
- “Be true to your work, your word, and your friend.” – John Boyle O’Reilly
- “Believe in yourself! Have faith in your abilities! Without a humble but reasonable confidence in your own powers you cannot be successful or happy.” – Norman Vincent Peale
- “Surprise is the greatest gift which life can grant us.” – Boris Pasternak
- “Logic will get you from A to B. Imagination will take you everywhere.” – Albert Einstein
- “It is the fight alone that pleases us, not the victory.” – Blaise Pascal
- “Do exactly what you would do if you felt most secure.” – Meister Eckhart
- “Life lived for tomorrow will always be just a day away from being realized.” – Leo Buscaglia
- “Wisdom is oftentimes nearer when we stoop than when we soar.” – Wordsworth
- “Take chances, make mistakes. That’s how you grow. Pain nourishes your courage. You have to fail in order to practice being brave.” – Mary Tyler Moore
- “A single twig breaks, but the bundle of twigs is strong.” – Tecumseh
- “If one does not know to which port one is sailing, no wind is favorable.” – Lucius Annaeus Seneca
- “There is little that can withstand a man who can conquer himself.” – Louis XIV
- “The limits of the possible can only be defined by going beyond them into the impossible.” – Arthur C. Clarke
- “Be faithful in small things because it is in them that your strength lies.” – Mother Teresa
- “The future rewards those who press on. I don’t have time to feel sorry for myself. I don’t have time to complain. I’m going to press on.” – Barack Obama
- “By three methods we may learn wisdom: First, by reflection, which is noblest; Second, by imitation, which is easiest; and third by experience, which is the bitterest.” – Confucius
- “No man was ever wise by chance.” – Lucius Annaeus Seneca
- “Progress is man’s ability to complicate simplicity.” – Thor Heyerdahl
- “It is not in the stars to hold our destiny but in ourselves.” – William Shakespeare
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“It does not matter how slowly you go as long as you do not stop.” – Confucius
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“I want to put a ding in the universe.” – Steve Jobs
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“Research is creating new knowledge.” – Neil Armstrong
- “The reward for work well done is the opportunity to do more.” – Jonas Salk
- “Man is a creative retrospection of nature upon itself.” – Karl Wilhelm Friedrich Schlegel
- “There’s something about taking a plow and breaking new ground. It gives you energy.” – Ken Kesey
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“Success seems to be largely a matter of hanging on after others have let go.” – William Feather
- “The essential conditions of everything you do must be choice, love, passion.” – Nadia Boulanger
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“More business is lost every year through neglect than through any other cause.” – Rose Kennedy
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“Give me a lever long enough and a fulcrum on which to place it, and I shall move the world.” – Archimedes
- “A person who won’t read has no advantage over one who can’t read.” – Mark Twain
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“The best way out is always through.” – Robert Frost
- “Start by doing what’s necessary; then do what’s possible; and suddenly you are doing the impossible.” – Francis of Assisi
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“Without labor nothing prospers.” – Sophocles
- “Intellectuals solve problems, geniuses prevent them.” – Albert Einstein
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“This is the precept by which I have lived: Prepare for the worst; expect the best; and take what comes.” – Hannah Arendt
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“The best and most beautiful things in the world cannot be seen or even touched – they must be felt with the heart.” – Helen Keller
- “He who is brave is free.” – Lucius Annaeus Seneca
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“When something is important enough, you do it even if the odds are not in your favor.” – Elon Musk
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“I choose a block of marble and chop off whatever I don’t need.” – Auguste Rodin
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“Hope is the only bee that makes honey without flowers.” – Robert Green Ingersoll
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“He who knows that enough is enough will always have enough.” – Lao Tzu
- “Plans to protect air and water, wilderness and wildlife are in fact plans to protect man.” – Stewart Udall
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“In order to carry a positive action we must develop here a positive vision.” – Dalai Lama
- “A hero is someone who understands the responsibility that comes with his freedom.” – Bob Dylan
- “Inflation destroys savings, impedes planning, and discourages investment. That means less productivity and a lower standard of living.” – Kevin Brady
- “If we give something positive to others, it will return to us. If we give negative, that negativity will be returned.” – Allu Arjun
- “A good plan violently executed now is better than a perfect plan executed next week.” ~ George S. Patton
- “You must do the things you think you cannot do.”- Eleanor Roosevelt
- “Success is dependent on effort.” – Sophocles
- “Nobody who ever gave his best regretted it.” – George Halas
- “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
- “And when I breathed, my breath was lightning.” – Black Elk
- “Moderation is the silken string running through the pearl chain of all virtues.” – Joseph Hall
- “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
- “If you want a guarantee, buy a toaster.” – Clint Eastwood
- “We are an impossibility in an impossible universe.” – Ray Bradbury
- “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
- “I’d rather attempt to do something great and fail than to attempt to do nothing and succeed.” – Robert H. Schuller
- “Do your little bit of good where you are; it’s those little bits of good put together that overwhelm the world.” Desmond Tutu
- “It takes considerable knowledge just to realize the extent of your own ignorance.” – Thomas Sowell
- “Do not dwell in the past, do not dream of the future, concentrate the mind on the present moment.” – Buddha”
- Surprise is the greatest gift which life can grant us.” – Boris Pasternak
- “Trust in dreams, for in them is hidden the gate to eternity.” – Khalil Gibran
- “Always be yourself, express yourself, have faith in yourself, do not go out and look for a successful personality and duplicate it.” – Bruce Lee
- “All life is an experiment. The more experiments you make the better.” – Ralph Waldo Emerson
- “There are no secrets to success. It is the result of preparation, hard work, and learning from failure.” – Colin Powell
- “There is more to life than increasing its speed.” – Mahatma Gandhi
- “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
- “Definiteness of purpose is the starting point of all achievement.” – W. Clement Stone
- “Success usually comes to those who are too busy to be looking for it.” – Henry David Thoreau
- “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
- “Life is too short for long-term grudges.” – Elon Musk
- “There cannot be a crisis next week. My schedule is already full.” – Henry Kissinger
- “Success consists of getting up just one more time than you fall.” – Oliver Goldsmith
- “The Earth is the cradle of humanity, but mankind cannot stay in the cradle forever.” – Konstantin Tsiolkovsky
- “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
- “Beauty surrounds us, but usually we need to be walking in a garden to know it.” – Rumi
- “But man is not made for defeat. A man can be destroyed but not defeated.” – Ernest Hemingway
- “Don’t watch the clock; do what it does. Keep going.” – Sam Levenson
- “Let there be work, bread, water and salt for all.” – Nelson Mandela
- “The social object of skilled investment should be to defeat the dark forces of time and ignorance which envelope our future.” – John Maynard Keynes
- “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
- “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
- “It is the fight alone that pleases us, not the victory.” – Blaise Pascal
- “If you can’t describe what you are doing as a process, you don’t know what you’re doing.” – W. Edwards Deming
- “Never interrupt your enemy when he is making a mistake.” – Napoleon Bonaparte
- “Be sure you put your feet in the right place, then stand firm.” – Abraham Lincoln
- “Without investment there will not be growth, and without growth there will not be employment.” – Muhtar Kent
- “You have to do your own growing no matter how tall your grandfather was.” – Abraham Lincoln
- “Victory has a thousand fathers, but defeat is an orphan.” – John F. Kennedy
- “Delete the negative; accentuate the positive!” – Donna Karan
- “It’s crazy how fast time flies and how things progress.” – Nathan Chen
- “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
- “Life isn’t about finding yourself. Life is about creating yourself.” – George Bernard Shaw
- “Everything has beauty, but not everyone sees it.” – Confucius
- “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
- “Walking with a friend in the dark is better than walking alone in the light.” – Helen Keller
- “A man who dares to waste one hour of time has not discovered the value of life.” – Charles Darwin
- “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
- “Progress is man’s ability to complicate simplicity.” – Thor Heyerdahl
- “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
- “Nothing is impossible, the word itself says ‘I’m possible’!” – Audrey Hepburn
- “But investment in space stimulates society, it stimulates it economically, it stimulates it intellectually, and it gives us all passion.” – Bill Nye
- “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
- “Life is a tragedy when seen in close-up, but a comedy in long-shot.” – Charlie Chaplin
- “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
- “Infrastructure investment in science is an investment in jobs, in health, in economic growth and environmental solutions.” – Oren Etzioni
- “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
- “Know thy self, know thy enemy. A thousand battles, a thousand victories.” – Sun Tzu
- “If one does not know to which port one is sailing, no wind is favorable.” – Lucius Annaeus Seneca
- “Beware of missing chances; otherwise it may be altogether too late some day.” – Franz Liszt
- “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
- “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
- “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
- “There is little that can withstand a man who can conquer himself.” – Louis XIV
- “In tennis, you strike a ball just after the rebound for the fastest return. It’s the same with investment.” – Masayoshi Son
- “A camel makes an elephant feel like a jet plane.” – Jackie Kennedy
- “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
- “Success depends upon previous preparation, and without such preparation there is sure to be failure.” – Confucius, Chinese
- “Coming together is a beginning; keeping together is progress; working together is success.” – Edward Everett Hale
- “Never do anything against conscience even if the state demands it.”– Albert Einstein
- “Education is not only a ladder of opportunity, but it is also an investment in our future.” – Ed Markey
- “The true measure of a man is how he treats someone who can do him absolutely no good.” – Samuel Johnson
- “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
- “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
- “The best preparation for tomorrow is doing your best today.” – H. Jackson Brown, Jr.
- “Friendship marks a life even more deeply than love. Love risks degenerating into obsession, friendship is never anything but sharing.” – Elie Wiesel
- “Investing in women’s lives is an investment in sustainable development, in human rights, in future generations – and consequently in our own long-term national interests.” – Liya Kebede
- “Success isn’t measured by money or power or social rank. Success is measured by your discipline and inner peace.” – Mike Ditka
- “No matter how many goals you have achieved, you must set your sights on a higher one.” – Jessica Savitch
- “Start where you are. Use what you have. Do what you can.”– Arthur Ashe
- “The secret of getting ahead is getting started.” – Mark Twain
- “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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