Stocks Take Shot of Red Bull, Charge Higher On Columbus Day – $AAPL $ADT $INVO $LBPH $LTRN $MODD $NVDA Rise!

By John F. Heerdink, Jr.

On a day that many had off, the stock market was open for business and it decided to play a game of “how high can we go?” Yes indeed on Columbus Day, the major indices charged higher like they had discovered a secret stash of Red Bull. The Dow Jones Industrial Average strutted its stuff, gaining 201.36 points to close at 43,065.22. Not to be outdone, the Nasdaq Composite jumped 159.75 points to 18,502.69, while the S&P 500 joined the party with a 44.82 point increase to 5,859.85. The little guy, the Russell 2000, also moved higher by .64% as did the micro minis as the iShares Micro-Cap ETF (IWC) closed at $124.97 up .82%. The SPDR S&P 500 Biotech ETF (XBI) rose .40% today, & is now up +10.95% YTD.

Sector Shenanigans

Tech Takes the Cake: Information Technology decided to flex its muscles, leading the pack of strong performers. It seems the sector has been hitting the gym lately, and it’s definitely showing.

Utilities and Real Estate: These sectors apparently didn’t get the memo about the housing market slowdown, as they charged ahead with surprising vigor.

Energy Takes a Nap: While everyone else was busy partying, the Energy sector decided to take a little siesta, ending up as the only sector in the red as oil prices dropped by 2.45% slipping back to $72.02/bbl as growth concerns floated across the world thanks to China’s ministry of Finance lack of clarity surrounding its stimulus measures.

Around The Horn…

Chip maker/AI giant NVIDIA (NVDA) kept moving higher and closed at $138.07, +2.43%

Palantir Technologies, Inc (PLTR) closed at $43.40, -.25%.

Apple (AAPL) closed at +1.65% at $231.30.

Biotech Buyout/Merger activity

H. Lundbeck A/S (Lundbeck) and Longboard Pharmaceuticals, Inc (NASDAQ: LBPH, $58.99, +51.65) today announced an agreement for Lundbeck to acquire Longboard. Under the terms of the agreement, Lundbeck will commence a tender offer for all outstanding shares of Longboard common stock, whereby Longboard shareholders will be offered a payment of USD 60.00 per share in cash. The transaction is valued at approximately USD $2.6 billion equity value and USD 2.5 billion (approximately DKK 17 billion) net of cash, on a fully diluted basis. Longboard is a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases. Its lead asset, bexicaserin, has shown encouraging anti-seizure reduction to date in preclinical and clinical studies, with its next-generation superagonist mechanism specifically targeting 5-HT2C receptors, which support bexicaserin’s potential to offer a highly differentiated and best-in-class profile. Bexicaserin is now being evaluated in a global phase III clinical program (the DEEp Program).

INVO Bioscience (NASDAQ: INVO, $1.24, +92.5466%) today announced it has closed its merger with NAYA Biosciences, a company dedicated to increasing patient access to breakthrough treatments in oncology and autoimmune diseases. The combined company expects to change its name to NAYA Biosciences and trade on the NASDAQ under the “NAYA” ticker. The combined company will continue to operate the revenue-generating fertility business as well as expand its focus to the development of first-in-class clinical-stage assets in oncology and autoimmune diseases. The combined company will be led by INVO Chief Executive Officer Steve Shum, INVO Chief Financial Officer Andrea Goren, and Dr. Daniel Teper, founder and former CEO of NAYA Biosciences, who will be appointed as President of the combined company and Chief Executive Officer of the NAYA Therapeutics subsidiary. Dr. Teper has over 30 years of strategic leadership experience as a biopharma entrepreneur, corporate executive, and management consultant. Two members of NAYA’s board, Dr. Teper and Ms. Lyn Falconio, will join the combined company’s board alongside INVO’s current board members.

The Bond Market

The fixed incoming markets were closed today in observance of Columbus Day.

Fear Index

The CBOE Volatility Index (VIX), often referred to as the “fear index,” closed at $19.70, -8.03% on the day after reaching a high of $23.11 during intraday trading.

The Fed Speaks… Sort Of

Fed Governor Waller decided to channel his inner Yoda, cryptically advising that monetary policy should “proceed with caution” on rate cuts.

Looking Ahead

Tomorrow brings us the October NY Fed Empire State Manufacturing Index report.

VP Watchlist Updates

Shares of Lantern (LTRN), an artificial intelligence (“AI”) company developing targeted and transformative cancer therapies using its proprietary RADR® AI and machine learning (“ML”) platform with multiple clinical stage drug program, closed at $3.55, +2.01% and is up +3.38% at $3.6699 in the aftermarket.

On September 23, Lantern announced that the company has been granted three rare pediatric disease designations (RPDD) by the FDA. Lantern was granted these rare pediatric disease designations in: malignant rhabdoid tumors (MRT), rhabdomyosarcoma (RMS), and hepatoblastoma. Rare pediatric diseases are defined by the FDA as serious or life-threatening conditions primarily affecting children under 18, with fewer than 200,000 cases in the U.S. A key benefit of obtaining a RPDD is the potential to receive a priority review voucher following FDA approval of a product with RPDD if the marketing application submitted for the product satisfies certain conditions, including approval prior to September 30, 2026 unless changed by legislation. These vouchers, often called “golden tickets,” can significantly expedite the review process for future NDAs or biologic license applications, reducing the standard review time from about ten months to six. Sponsors can either use these vouchers themselves or sell them to other companies. These vouchers, in the recent past, have commanded sales prices of approximately $100 million USD.

Panna Sharma is the President, CEO, and Board Member of Lantern Pharma Inc.

“At Lantern, we’re harnessing AI and data-driven approaches to revolutionize cancer drug development, aiming to dramatically reduce costs, accelerate timelines, and enhance precision in bringing new therapies to patients. Our recent breakthrough in identifying three additional, high-potential indications for LP-184 in pediatric cancers exemplifies this progress. We believe that ‘AI for good’ should address both blockbuster opportunities as well as rare, often overlooked pediatric cases. The FDA’s Rare Pediatric Disease designation for these three potential programs is a testament to this commitment. We’re acutely aware that patients and their families are relying on innovators like us to speed up therapy development. These designations mark a crucial step forward in advancing our expanding portfolio of pediatric programs targeting these devastating and rare cancers. It reinforces our dedication to transforming hope into tangible solutions for those who need them most,” stated Panna Sharma, CEO and President of Lantern Pharma.

On August 9, announced operational highlights and financial results for the second quarter 2024, ending June 30, 2024 highlighting the following:

Active clinical trials across three AI-guided drug candidates with additional ADC-based preclinical molecules in evaluation for development.
Preliminary patient data and clinical readouts for Phase 2 LP-300 Harmonic™ Trial released showing an 86% clinical benefit rate in the initial 7 patient safety lead-in cohort.
Issued a Certificate of Patent by the Japanese Patent Office directed to Lantern Pharma’s drug candidate LP-284, including claims covering the new molecular entity.
Phase 1 clinical trials for both synthetic lethal drug candidates, LP-184 and LP-284, continue to advance with no dose-limiting toxicities observed in any of the patient cohorts enrolled and over 40 patients dosed to-date.
Achieved significant advancement towards key milestone in the development of molecular diagnostic for use with drug candidate LP-184 in future oncology clinical trials to improve patient selection and stratification.
Launched strategic drug development collaboration leveraging our AI platform, RADR®, with Oregon Therapeutics to optimize the development of first-in-class drug candidate XCE853 – a potent inhibitor of cancer metabolism.
Starlight Therapeutics, a wholly owned subsidiary of Lantern Pharma focused on CNS and brain cancers advanced with initiating site selection and feasibility for a Phase 1B/Phase 2 trial in recurrent GBM with drug candidate, STAR-001.
Launched Webinar Wednesdays, a webinar series that focuses on the areas of artificial intelligence and oncology drug development with leading physicians, scientists and Lantern collaborators.
Approximately $33.3 million in cash, cash equivalents, and marketable securities as of June 30, 2024.

Modular Medical, Inc. (NASDAQ: MODD, $2.17, +1.40% & is up +135,87% over the last year), an insulin delivery system technology company preparing to launch a market expansion product with a more accessible, easier to prescribe, and easier to pay for and live with 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 October, Modulars CEO was interviewed by Carole Sullivan on the Today In Nashville program affiliated with Channel 4 WSMV. The segment is called “New Tools for Treating Diabetes by Modular Medical.” You may watch the video now at this link.

On September 18, Modular Medical announced the issuance of U.S. Divisional Patent Application No. 17/968,599. “The issuance of this patent and the associated claims represent a major step in our efforts to protect the intellectual property in the MODD1 pump platform,” stated Jeb Besser, CEO of Modular Medical. “Some of the key features of our novel, low-cost and accurate insulin delivery technology are now protected by this important issued U.S. patent, which we believe represents a significant new barrier to entry. Our eight families of patents around our pump are an important part of our strategic value and market positioning, and we look forward to announcing further issuances on our portfolio in the future.”

On September 11, Modular Medical’s CEO Jeb Besser presented at Tribe Public’s Webinar Presentation and Q&A Event titled “Diabetes, Obesity, GLP-1, & The MODD-1 Opportunity.” The event video has now been viewed over 47,000 times and can now be viewed below:

On Wednesday, September 4, Modular announced it has received U. S. Food and Drug Administration (“FDA”) clearance to market and sell its MODD1 pump in the United States. With its commercial manufacturing infrastructure substantially established, the Company anticipates the MODD1 should be available for sale in early 2025.

James (Jeb) Besser, CEO of Modular Medical (NASDAQ: MODD)

“For too long, the benefits of superior glycemic control achieved by insulin pumps have, due to cost and complexity, been restricted to only the most sophisticated, motivated and well-insured users. The goal of Modular Medical has always been to change this by making diabetes technology accessible and affordable to underserved communities. We seek to make the experience of going ‘on a pump’ simpler and less intimidating and to widen the base beyond the current pump users,” said Jeb Besser, CEO of Modular Medical.

Paul DiPerna, Chairman and President of Modular Medical

“I want to thank our employees for their hard work and dedication in bringing this product to the market and our shareholders for their ongoing support of the Company. We will continue to deliver on our mission of enabling ‘diabetes care for the rest of us’ and delivering on the needs of all patients and clinicians,” added Paul DiPerna, Chairman and President of Modular Medical.

Shares of Indaptus Therapeutics, Inc. (Nasdaq: INDP) closed at $1.23, -3.15% and is up another +14.63% at $1.41 in the aftermarket. 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.

Indaptus announced that Jeffrey A. Meckler, Chief Executive Officer, will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit with Jason McCarthy, Ph.D., Senior Managing Director, Head of Biotechnology Research at Maxim Group. The summit is being held virtually on October 15 – 17, 2024. Event: Fireside Chat at 2024 Maxim Healthcare Virtual Summit, Date: Wednesday, October 16, 2024, Time:11:00 AM ET Webcast: https://m-vest.com/events/healthcare-10152024

On September 5, Indaptus provided an update regarding key clinical advancements. The independent Safety Review Committee overseeing the Company’s Phase 1 clinical trial convened in August to review the safety data at the higher Decoy20 dose with single dose administration and the safety data at the lower Decoy20 dose with weekly administration. The safety profile being observed to date continues to be consistent with Decoy20’s mechanism of action. The most clinically relevant treatment-related adverse events — infusion-related reaction and hypotension – have been mild-to-moderate in severity, and resolved quickly with i.v. fluids or over-the-counter therapy.

The encouraging data has led to the decision to:

Continue dosing additional patients at the lower Decoy20 dose on a weekly schedule
Initiate dosing patients at the higher Decoy20 dose on a weekly schedule

“We continue to be encouraged by the evolving safety profile of Decoy20 during the expansion part of our Phase 1 trial. Our goal is to continue to evaluate patients receiving two distinct weekly doses of Decoy20 to identify potential monotherapy activity, and to accumulate sufficient safety data to initiate combination therapy next year,” said Dr. Roger Waltzman, Indaptus Chief Medical Officer. “We ultimately believe that Decoy20’s broad but transient activation of multiple cytokines and chemokines responsible for stimulating both innate and adaptive immune pathways in concert with other therapies will enhance tumor regression.”

Jeffrey Meckler, Chief Executive Officer, added, “The clinical trial is progressing as planned. Enrolling multiple patients at two different weekly doses should accelerate the progress of our trials. We look forward to providing more updates later in the year.”

On Aug. 12, Indaptus announced financial results for the second quarter ended June 30, 2024, and provided a corporate update. Jeffrey Meckler, Indaptus Therapeutics’ Chief Executive Officer, commented, “During the second quarter we had multiple opportunities to share our findings regarding our Phase 1 clinical trial to date, and to demonstrate the unique approach that our Decoy platform offers. These included impactful conferences such as the American Association for Cancer Research (AACR) annual meeting and the American Society of Clinical Oncology (ASCO) annual meeting, which are considered among the top annual oncology conferences. Further, our founder was once again recognized by the industry when he was named chair of the STING & TLR-Targeted Therapies Summit. We are encouraged by the results we have reported, along with the data we are seeing as we continue the multi-dose stage of the Phase 1 clinical trial. As Decoy20 continues to be well-tolerated in our Phase 1 clinical trial, we expect to progress to dosing multiple patients simultaneously. This will increase the data we receive and, as a result, is expected to accelerate the progress of the trial. We look forward to demonstrating continued impactful outcomes in the second half of the year.”

Key recent highlights:

Completed a $3 million registered direct offering and concurrent private placement on August 8, 2024, for net proceeds of approximately $2.5 million
Advancing clinical trial from single to weekly doses of Decoy20, the company completed one month of weekly dosing in three patients at the 3-x 10^7 Decoy20 dose
Completed a single dose cohort at the higher dose of 7 x 10^7 Decoy20 and intend to initiate weekly dosing later this year
Presented poster outlining data from 3 x 10^7 and 7 x 10^7 dose at the ASCO annual meeting on June 1, 2024, in Chicago
Presented poster outlining new mechanism of action data for Decoy platform at the AACR annual meeting in April 2024
Founder and Chief Scientific Officer, Michael Newman, Ph.D. presented additional data on the Company’s lead product candidate, Decoy20, at the 5^thAnnual STING & TLR-Targeted Therapies Summit in San Diego on June 19-20, 2024, where he was also named chair of the Summit

Eupraxia Pharmaceuticals (EPRX, $2.36, -7.81%) is a clinical-stage biotechnology company leveraging its proprietary DiffuSphere™ technology to optimize drug delivery for applications with significant unmet need. The Company strives to provide improved patient benefit and has developed technology designed to deliver targeted, long-lasting activity with fewer side effects. DiffuSphere™, a proprietary, polymer-based micro-sphere technology, is designed to facilitate targeted drug delivery, with extended duration of effect, and offers multiple, highly tuneable pharmacokinetic (PK) profiles. This investigational technology can be engineered for use with multiple active pharmaceutical ingredients and delivery methods.

Eupraxia is presenting a poster at the United European Gastroenterology (“UEG”) Week 2024 held in Vienna, Austria, on October 12-15, 2024.

On Sept. 19, Eupraxia presented a poster at the upcoming 20th International Symposium on Digestive Endoscopy (“ISDE”) World Congress for Esophageal Diseases that was held in Edinburgh, Scotland on September 22-24, 2024.

On, September 11, Eupraxia announced additional positive clinical data from its RESOLVE Phase 1b/2a trial, which is evaluating the safety and efficacy of EP-104GI as a treatment for eosinophilic esophagitis (“EoE”). The results announced today from the fourth cohort of the RESOLVE trial, using Eupraxia’s DiffuSphere™ technology for EoE, are derived from twelve 2.5 mg injections of EP-104GI (total dose of 30 mg) administered to less than two-thirds of each patient’s lower esophagus. The data show:

Straumann Dysphagia Index (“SDI”)1, a patient-reported outcome measure designed to assess symptom severity, was lower for all three patients post-administration with peak reductions up to four points (67% from baseline). At 12 weeks post-administration, SDI was reduced by a mean of 45% or 3.3 points – a level comparable with currently approved therapies.
Eosinophilic Esophagitis Histology Scoring System (“EoEHSS”)2 scores, which evaluate the severity and extent of EoE, showed the largest percent reduction of any cohort to date, with a mean 39% reduction in Composite Stage and a mean 37% reduction in Composite Grade at 12 weeks – a level comparable with currently approved therapies.
Using data from four biopsy sites, which is consistent with the U.S. Food and Drug Administration (“FDA”) Guidance for Developing Drugs for the Treatment of EoE, the mean reduction in Peak Eosinophil Counts (“PEC”)3 was 67% at 12 weeks.

On July 9, a Tribe Public CEO Presentation and Q&A Webinar Event titled “Exploring The Rapid Rise Of Osteoarthritis” was held with James A. Helliwell, MD, Director and Chief Executive Officer of Eupraxia Pharmaceuticals (NASDAQ: EPRX). Please view the event video below:

Shares of ADT Inc. (ADT), a leading provider of monitored security and automation solutions for residential and small business customers in the United States and Canada, closed at $6.87, -.15% after recently establishing a new 52-wk high of $7.92 during intraday trading.

On Aug. 21, ADT announced the appointment of Suzanne Yoon to the Company’s Board of Directors as an additional independent director. Yoon is the founder and managing partner of Kinzie Capital Partners, a Chicago-based private equity firm. In 2017, she launched Kinzie and currently serves as the Chair of its Investment and Management Committees. Prior to founding Kinzie, Yoon held senior roles at Versa Capital Management, CIT Group and LaSalle Bank/ABN AMRO. She is a current member and former Chair of the National Philanthropic Trust Board of Trustees, the largest independent donor advised fund manager in the world with approximately $40 billion under management and is a member of the first-ever Women’s Advisory Board for the Chicago Bears.