Soft Landing & AI Rhetoric Fuels Weekly Stock Market Gains – $ADT $BFRG $CRBP $DECK $LTRN $MODD $MSFT $NVDA Rise!

By John F. Heerdink, Jr.

Quote of the Day: “Leadership is the capacity to translate vision into reality.” – Warren Bennis

Happy Saturday!

I hope you all had a great week. I spent this week in San Francisco, but will be heading out to Dallas, Texas next week to co-host two Complimentary CEO Presentation and Q&A Dinner and Events at 6pm on Jan. 30 and at noon pm Jan. 31 with our sister organization Tribe Public. “The events will be co-hosted by Indaptus Therapeutics’ (NASDAQ: INDP) CEO, Jeffrey Meckler and his presentation is titled “Immunotherapy Reimagined”. If you would like to attend one of the events, then please request further details by replying to research@tribepublic.com.

As for the broad markets, the large caps moved up solidly again, but the the lower end of the markets realized an even better week of gains. The overarching AI theme continued to push many stocks higher, but the beliefs and the data that inflation may be under control helped fuel further beliefs that that the Fed may ease at some point. On Monday, the December Leading Economic Index clocked in at -.1%. On Wednesday, the preliminary S&P Global US Manufacturing PMI report and the S&P Global US Services PMI report for January were both confirmed to be expansion territory. On Thursday, the Real GDP report confirmed an increase at an annual rate of 3.3% in Q4 as personal consumption expenditures rose 2.8%. The GDP Pride Deflator report also was up 1.5%. The Initial jobless claims report for the week ending January 20 showed a rise by 25k to 214k, while the Continuing jobless claims report for the week ending January 13 also confirmed a rise by 27k to 1.833M. The Durable goods orders report came in flat in December. The Advance International Trade in Goods deficit tighter up to $88.5B in December, while the Advance Retail Inventories report clocked in up .8% & the Advance Wholesale Inventories reported showed a rise by .4%. Also the New home sales report registered an 8% M/M rise in December to a seasonally adjusted annual rate of 664k units. On Friday, the Personal income report confirmed a .3% M/M rise in December & personal spending rose .7% greater than expected. The PCE Price Index report clocked in with a .2% M/M rise. wale the PCE Price Index came in up 2.6% & the core PCE Price Index was up 2.9%Y/Y. Finally, the Pending home sales report showed a 8.3% jump in December.

In concert, the yield curve diverged this week as the 2-yr yield fell 5bps to 4.36% and the 10-yr closed at 4.16%, up 1bps after last week’s double digit jump. The U.S. Dollar Index also rose from 103.24 to 103.47. Interestingly, the CBOE Volatility Index (^VIX) fell to $13.26 from $13.30 & oil prices rose from $73.41/bbl to $78.12/bbl.

At the end of the week, the Dow 30 closed at 38,109 (+.6%) this week and is now up 1.1% YTD & S&P 500 closed at 4,891 (+1.1%) at a new record high and is now up 2.5% YTD as 8 of the 11 sector closed in the green, & the Nasdaq closed at 15,455 (+.09%) and is now up 3% YTD.

The Magnificent Seven closed as follows. (over the last 5-days): Alphabet (GOOG) closing at $153.79, +3.93% Amazon (AMZN) closing at $155.34, +2.43%, Apple (AAPL) at $192.42, +.45%, Meta Platforms (META) closing at $394.14, +2.79%, Microsoft (MSFT) closing at $403.93, +1.32% while topping the $3T market cap value fir the first time, NVIDIA (NVDA) closing at $610.31, +2.59%, & Tesla (TSLA) tanked after missing earnings expectations closing at $183.25, -13.64%.

The small caps on the Russell 2000 closed at 1,978.33 (+1.75%) for the week & is now down 2.40% YTD, while the MicroCaps also moved significantly lower this week as the iShares Micro-Cap ETF (IWC) closed at $113.15 up 2.68%.

Bank stocks rose as the SPDR S&P Regional Banking ETF (KRE) moved up over the last 5-days to close at $52.13 up from $51.03 & the SPDR S&P Bank ETF (KBE) moved down over the last 5-days to close at $46.16 up from $45.26.

Overall, The Nasdaq Biotechnology ETF (IBB) closed at $135.35 up from $135.18, the NYSE ARCA Biotech Index (^BTK) closed at 5,276.72 up from 5,201.97, & the SPDR S&P Biotech ETF (XBI) closed at $88.24 up from $87.05. The iShares U.S. Healthcare ETF (IYH) closed at $292.13 down from $292.43 over the last 5-days.

Cathie Wood’s ARK Innovation ETF (ARKK) closed at $45.92, down .78% over the last 5-days.

From the world of cryptocurrency, Bitcoin (BTC) moved to 41,944.83, +6.30% over the course of the last 5-days at the time of the completion of this message.

Gold prices closed at $2,018 down from $2,030 over the last 5-days. Silver prices closed at $22.85. The Global X Silver ETF (SIL) closed at $25.51 up from $25.08 over the last 5-days.

VP Watchlist Updates

Modular Medical, Inc. (NASDAQ: MODD, $1.91, +6.70% over last 5-days and +85.44% over the last 6-months), is a development-stage medical device company that intends to launch the next generation of insulin delivery technology. Using its patented technologies, the company seeks to eliminate the tradeoff between complexity and efficacy, thereby making top quality insulin delivery both affordable and simple to learn. Their mission is to improve access to the highest standard of glycemic control for people with diabetes taking it beyond “superusers” and providing “diabetes care for the rest of us.” Modular Medical was founded by Paul DiPerna, a seasoned medical device professional and microfluidics engineer. Prior to founding Modular Medical, Mr. DiPerna was the founder (in 2005) of Tandem Diabetes and invented and designed its t:slim insulin pump. More information is available at https://modular-medical.com.

On Jan. 24, Modular Medical announced the issuance of U.S. Patent 11,817,197 B2 for the stream-lined pairing of a pump to a mobile device. Paul DiPerna, Chairman and CTO of Modular Medical, commented, “The issuance of this patent is just another step in our mission to use technology to rethink and simplify the adoption of and ability to live with pump technology for patients and caregivers. To address cybersecurity risks and the complexity of pairing multiple devices to talk between a phone and a pump, we added Near-Field Communication (NFC), whereby, just by bringing the phone close to our pump will create a secure connection making it much easier to develop, test and maintain. This patent protects our technology addressing pairing, and, most importantly, the downloading of patient data to allow clinicians to easier upload and review the patients data. The patient’s phone is not required, and a clinician can simply tap the pump to the phone or tablet to pull the data using Bluetooth from patient pumps. In a high-volume practice, such as a busy certified pump trainer’s office, the ability to pull data from several patients quickly is critical. Our patented technology addresses the ability to do this without the tedious step of powering on and pairing with a myriad of new Bluetooth devices. It also simplifies moving the configuration to a new reusable controller, when needed, without using an intermediate device.” Jeb Besser, Modular Medical’s CEO, commented, “Our family of patents, which includes both issued patents and pending applications, around our pump is an important part of our strategic value and market positioning, and we look forward to announcing further patent issuances in the future.”
On Jan. 19, Modular Medical announced the premarket submission of its MODD1 next-generation insulin pump to the FDA for 510(k) clearance. “This is an exciting milestone for the Company, as we seek to change the diabetes market. Almost 30 years after the introduction of the first insulin pump, more than three quarters of those who could benefit from wearing a pump do not wear one. It is our belief that our simplified design will encourage many “almost-pumpers” to adopt technology to aid in their diabetes management, without the complexity and expense required by many of the current solutions,” said Paul DiPerna, Chairman and CTO of Modular Medical.

On Dec. 21, Modular Medical announced a collaboration agreement with Glooko, Inc., a global leader specializing in connected care and remote patient monitoring for diabetes. Integrating with Glooko will allow clinicians and patients to easily review insulin dosing data from the MODD1 pump, when commercially available. In addition, through Glooko’s platform, Dexcom CGMS users will be able to view their glucose levels in the same accessible format in conjunction with their pump data. Glooko’s platform has a broad installed base, which has been deployed in over 30 countries and 8,000 clinical locations. Jeb Besser, CEO of Modular Medical stated, “We are extremely pleased to add the Glooko technology platform to our diabetes care system making it even easier and more cost effective for us to provide this important capability to our clinical and patient base. Glooko’s mission to improve health outcomes of people with chronic conditions through its personalized, intelligent, connected care platform fits perfectly with our vision of providing an easy to use, affordable delivery technology to give more patients access to better care.”

Lantern (LTRN) closed at $4.19, +6.19% over the last 5-days. 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 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.

On Nov. 30, Lantern announced that the U.S. Food and Drug Administration (FDA) has granted LP-284 Orphan Drug Designation (ODD) for the treatment of high-grade B-cell lymphoma with MYC and BCL2 rearrangements. Lantern highlighted that the Orphan Drug Designation strengthens LP-284’s clinical development path and can provide for additional market exclusivity and commercial protection, Lantern has initiated a first-in-human Phase 1 trial (NCT06132503) for LP-284 in B-cell non-Hodgkin’s lymphomas (NHL), including high-grade B-cell lymphoma (HGBL) and mantle cell lymphoma (MCL), & this Orphan Drug Designation marks the second such designation for drug-candidate LP-284 this year.

On Nov. 8, Lantern announced operational highlights and financial results for the third quarter ended September 30, 2023 highlighting the following:

Received IND clearance from FDA to initiate Phase 1 clinical trial for LP-284, a first-in-human trial for advanced, refractory non-Hodgkin’s lymphomas (NHL).
Dosed initial patient in Phase 1 with LP-184, a clinical trial for multiple advanced solid tumors that are refractory to standard-of-care therapies.
Progressed Phase 2 LP-300 Harmonic™ clinical trial towards enrollment in East Asian countries where 30-35+% of all lung cancer cases occur in never-smokers with NSCLC; continued expansion of additional clinical trial sites in the US and increased focus on recruitment activity with advocacy groups.
Developed initial proof-of-concept and preclinical evidence for a novel cryptophycin-based ADC (antibody-drug conjugate); initial data is planned to be shared in January 2024.
Furthered development of Lantern’s AI platform, RADR®, to include modules for the streamlined development of ADCs and the prediction of drug combinations with existing approved checkpoint inhibitors.
Approximately $45 million in cash, cash equivalents, and marketable securities as of September 30, 2023, is anticipated to provide a cash runway into at least Q3 of 2025.

Deckers Brands (NYSE: DECK, $767.79, +2.47% over the last 5-days & +79.70% over the last year) is a global leader in designing, marketing, and distributing innovative footwear, apparel, and accessories.

On Jan. 25, 2024 Building on the successful partnership that launched in 2018, Life Time (NYSE: LTH) and HOKA, a division of Deckers Brands (NYSE: DECK), announced plans for an extended and expanded multi-year relationship that will continue to inspire people of all ages to find joy in movement wherever they choose to be active. “It’s been phenomenal to hear how HOKA has impacted the performance of our members, coaches and trainers, and to see the success of this multi-faceted strategic partnership as we grow both of our brands,” said Kimo Seymour, President, Life Time Events. “We have created an incredible synergy between Life Time and HOKA, and it’s one we are very excited to continue as we collectively promote a healthy way of life and provide tools to help people achieve their wellness goals and aspirations.” The expanded agreement includes HOKA as an official sponsor of the upcoming Miami Marathon featuring a large buildout at the Marathon Expo and on the race course with their “Fly Human Fly” activation, encouraging and inspiring race participants as they head toward the finish line. Additionally, Life Time recently launched a new video series, Reveal Your Potential, highlighting individuals who’ve made Life Time and HOKA a part of their healthy and happy lives, and reminding people that each day provides an opportunity to redefine what’s possible. The series is being shared in Life Time clubs, online, socially, in print and through other marketing tactics. Inside Life Time’s portfolio of more than 170 athletic country clubs, HOKA is the official sponsor of select Life Time group classes and signature group training programs, including GTX, MB360 and Ultra Fit; and Dynamic Personal Training (DPT). HOKA will also sponsor Life Time’s annual cardio party with classes and social hour components hosted at Life Time destinations.

Shares of Indaptus Therapeutics, Inc. (Nasdaq: INDP) closed at $1.66, but traded to $1.83, up +10.24% in the aftermarket on Friday.

Indaptus is a company with the ability to harness both the body’s innate and adaptive immune responses, believes that they are uniquely positioned to revolutionize the treatment of cancer and certain infectious diseases. Indaptus Therapeutics has evolved from more than a century of immunotherapy advances. The Company’s novel approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells and pathways and associated anti-tumor and anti-viral immune responses will require a multi-targeted package of immune system-activating signals that can be administered safely intravenously (i.v.). Indaptus’ patented technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria producing a multiple Toll-like receptor (TLR), Nucleotide oligomerization domain (Nod)-like receptor (NLR) and Stimulator of interferon genes (STING) agonist Decoy platform. The products are designed to have reduced i.v. toxicity, but largely uncompromised ability to prime or activate many of the cells and pathways of innate and adaptive immunity. Decoy products represent an antigen-agnostic technology that have produced single-agent activity against metastatic pancreatic and orthotopic colorectal carcinomas, single agent eradication of established antigen-expressing breast carcinoma, as well as combination-mediated eradication of established hepatocellular carcinomas and non-Hodgkin’s lymphomas in standard pre-clinical models, including syngeneic mouse tumors and human tumor xenografts.

In pre-clinical studies tumor eradication was observed with Decoy products in combination with anti-PD-1 checkpoint therapy, low-dose chemotherapy, a non-steroidal anti-inflammatory drug, or an approved, targeted antibody. Combination-based tumor eradication in pre-clinical models produced innate and adaptive immunological memory, involved activation of both innate and adaptive immune cells, and was associated with induction of innate and adaptive immune pathways in tumors after only one i.v. dose of Decoy product, with associated “cold” to “hot” tumor inflammation signature transition. IND-enabling, nonclinical toxicology studies demonstrated safe i.v. administration without sustained induction of hallmark biomarkers of cytokine release syndromes, possibly due to passive targeting to liver, spleen, and tumor, followed by rapid elimination of the product. Indaptus’ Decoy products have also produced significant single agent activity against chronic hepatitis B virus (HBV) and chronic human immunodeficiency virus (HIV) infections in pre-clinical models.

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.”

On Nov. 6, Indaptus announced interim data from the first cohort of four patients in the Phase 1 INDP-D101 trial of its lead compound, Decoy20. A broad expression of cytokines and chemokines associated with innate and adaptive anti-tumor immune responses was observed, while adverse events were generally tolerable and resolved within 30 minutes to three days. Decoy20 is designed to “re-set” the immune system’s response to cancer. The poster was presented on November 4, 2023, at the Society for Immunotherapy of Cancer in San Diego.

“We are impressed that we saw short-term induction of more than 50 cytokines, chemokines and biomarkers and believe this is unprecedented with a single agent. These early data support our long-standing hypothesis that the Decoy platform may induce robust immune responses across multiple types of immune cells that we believe are important for the eradication of solid tumors,” commented Indaptus CEO Jeffrey Meckler. Learn more here.

Also, on Nov. 6, Indaptus announced financial results for the third quarter ended September 30, 2023 and provided a corporate update.

“We continue to be encouraged by early results from our first cohort of patients in the INDP-D101 trial evaluating Decoy20 for the treatment of solid tumors. As we recently reported and presented at the Society for Immunology in Cancer (SITC) conference, all four first cohort patients have maintained stable disease since receiving their single dose and presented evidence of immune activation, along with short-lived adverse events consistent with Decoy20’s mechanism of action, and we look forward to continuing to track them. In the meantime, we have already dosed our first patient in the second cohort, for which we have titrated the dose down in anticipation of a similar response. We continue to expect to have the second cohort completed by early 2024, which would provide guidance for the selection for the recommended Phase 2 dose for subsequent multi-dosing and combination studies, which are also planned for 2024,” said Jeffrey Meckler, Chief Executive Officer of Indaptus. “We are also fortunate to be receiving the benefit of our appointment of industry veteran, Roger Waltzman, M.D., as our Chief Medical Officer, who has already proven valuable even in this short period. We anticipate continuing to benefit from his expertise as we move forward with our Phase 1 trial and further develop the Decoy platform. In the meantime, we are prudently managing our cash position.”

Learn more about Indaptus Therapeutics (NASDAQ: INDP) at the VP Watchlist page by clicking here.

Shares of ADT Inc. (ADT), the most trusted brand in smart home and small business security, closed at $6.63, +5.74% over the last 5-days.

On Jan. 25, ADT announced it will be exiting its residential solar business. The Company will remain focused on cash flow generation and capital-efficient growth within its core security and smart home business. As part of this continued focus, ADT is also advancing its capital allocation strategy, including a cash dividend increase and authorization of a new share repurchase program. Over the first nine months of 2023, ADT’s core business exhibited strong performance, while the solar business faced challenges, including operational difficulties and macroeconomic headwinds causing deterioration of conditions industrywide. As a result of these challenges, the Solar segment generated an Adjusted EBITDA loss of $89 million during this period. Following the previously announced restructuring of its solar footprint and a detailed strategic review, ADT’s Board of Directors has approved the exit of this segment, which may include the transfer of components of the business to other parties. The Company expects to incur certain one-time exit charges and cash expenditures with potential offsets from asset sales or reduced tax expenses. As previously disclosed, as of September 30, 2023, the goodwill balance for the Solar reporting unit was zero. At this time, the Company is still analyzing the estimated net amount or range of amounts expected to be incurred in connection with this plan. Dividend Increase – The Company’s Board of Directors has declared a quarterly cash dividend of $0.055 per share, payable on April 4, 2024, to shareholders of record at the close of business on March 14, 2024. The quarterly dividend represents a 57% increase over the previous quarterly dividend. Share Repurchase Authorization – The Company’s Board of Directors has authorized a $350 million share repurchase program. As the Company executes share repurchases, the Board will periodically review the remaining authorization as part of its capital allocation strategy. Balance Sheet Fortification – Consistent with the plan from its third quarter earnings announcement, on December 29, 2023, the Company repaid $500 million of First Lien Senior Secured Notes due 2024, completing an overall 2023 reduction of ADT’s total debt by approximately $2 billion. Further, following two corporate rating upgrades in 2023, the Company improved borrowing costs and extended debt maturities and in 2024, will have only $150 million of maturities and amortization payments. The Company remains focused on achieving its targeted net leverage ratio of less than 3.0x. Core Investment – On December 20, 2023, the Company closed on a strategic bulk purchase of approximately 57,000 customer accounts for $89 million cash with attractive returns. This portfolio of customers is concentrated in a few key geographies, all of which align with existing platforms, enabling strong economies of scale upon integration. This transaction was not included in prior cash flow guidance. More details and an update on the business will be provided when the Company releases its fourth quarter and full year 2023 results on February 28, 2024. Following the release, management will host a conference call at 10 a.m. ET to discuss the financial results and lead a question-and-answer session.Participants may listen to a live webcast through the investor relations website at investor.adt.com.

Shares of Seanergy Maritime Holdings Corp. (SHIP), the only pure-play Capesize ship-owner publicly listed in the U.S. closed at $8.01, +.13% over the last 5 days, +33.50% over the last year. 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 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.

StoneCo Ltd. (Nasdaq: STNE, $18.10, +6.28% over the last 5-days and 56.03% over the last year), is a leading provider of financial technology and software solutions that empower merchants to conduct commerce seamlessly across multiple channels and help them grow their businesses.

On Jan. 5, StoneCo received from the Brazilian Central Bank (“BCB”) the “Financeira” License, organized as a Sociedade de Crédito, Financiamento e Investimento (SCFI). This license will enable StoneCo, through its subsidiaries, to develop and offer a range of new products, such as time deposits, which shall enhance and diversify the funding sources of the Company.

On Dec. 18 StoneCo announced that it has obtained a commitment of US$467.5 million in the form of a revolving securitization facility from the United States International Development Finance Corporation (DFC), an agency of the United States government. The facility, which has a final maturity of seven years, and a six-month availability period, acquires accounts receivables due by over twenty different non-systemic important Brazilian financial institutions that are credit card issuers, on a non-recourse basis. It will further strengthen Stone’s ability to offer prepayment of receivables to micro, small, and medium-sized businesses (MSMBs), which use the solution to optimize cash flow, financial flexibility and improve management. The closing of the transaction is subject to customary conditions precedents.

On Jan, 23, NAYA Biosciences Inc. (“NAYA”), a company which has recently signed a definitive merger agreement with INVO Bioscience (INVO, $1.04) 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.”

BullFrog AI Holdings, Inc. (NASDAQ: BFRG, $7.04, +43.97% over the last 5-days), a technology-enabled drug development company using artificial intelligence (AI) and machine learning to enable the successful development of pharmaceuticals and biologics, announced on Jan.17 the early results from its collaboration with the Lieber Institute for Brain Development (LIBD) that “could revolutionize the understanding and treatment of psychiatric disorders.’ The early findings from this global strategic partnership have successfully stratified brain expression data, offering what may turn out to be unprecedented insights into psychiatric conditions.

Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP, $$29.49, +249.41%), announced on Jan. 26 that data from the first-in-human clinical study of CRB-701 (SYS6002) is being presented as a poster by the Company’s development partner CSPC Pharmaceutical Group at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU). The Phase 1 dose escalation study is being conducted in China and is enrolling participants with metastatic urothelial cancer (mUC) as well as participants with other solid tumors prospectively confirmed to have nectin-4 positive tumors. The study opened for enrollment in January 2023 and data through December 2023 from the first eighteen participants reflective of the first six dose cohorts (0.2-3.6mg/kg) will be shared.

Thanks again for your attention this week. Please continue to share your thoughts, questions, & ideas as we move forward.

In the meantime, please enjoy the balance of the weekly newsletter’s videos, quotes, updates and let’s find ways to crush it again as we move forward!

Investing & Inspiration

“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
“It does not matter how slowly you go as long as you do not stop.” – Confucius
“I want to put a ding in the universe.” – Steve Jobs
“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
“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
“More business is lost every year through neglect than through any other cause.” – Rose Kennedy
“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
“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
“Without labor nothing prospers.” – Sophocles
“Intellectuals solve problems, geniuses prevent them.” – Albert Einstein
“This is the precept by which I have lived: Prepare for the worst; expect the best; and take what comes.” – Hannah Arendt
“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
“When something is important enough, you do it even if the odds are not in your favor.” – Elon Musk
“I choose a block of marble and chop off whatever I don’t need.” – Auguste Rodin
“Hope is the only bee that makes honey without flowers.” – Robert Green Ingersoll
“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
“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