Tuesday – Rise!

By John F. Heerdink, Jr.

Wall Street took a tumble on Monday, with major indices closing in the red as investors grappled with geopolitical tensions, oil price surges, and notable tech stock downgrades. The Dow Jones Industrial Average plummeted 398.51 points to 41,954.24, the Nasdaq Composite nosedived 213.95 points to 17,923.90, and the S&P 500 sheded 55.13 points to close at 5,695.94. It seems Wall Street decided to host its own version of a financial bungee jump, minus the fun and adrenaline rush. On the small end of the curve, the small caps on The Russell 2000 dropped again by .89% to close at 2,193.09 today and the iShares Micro-Cap ETF (IWC) also ticked lower to close at $121.74 down .52%. The SPDR S&P 500 Biotech ETF (XBI) fell significantly down 1.21% today, but remains up +7.88% YTD. Treasury yields rose across the curve, with the 10-year yield settling 5bps higher at 4.03% and the 2-yr yield rose 7bps at 4%.

Tech Giants’ Downgrade Drama

In a plot twist worthy of a Silicon Valley soap opera, tech titans found themselves starring in “The Day the Stocks Stood Still.” Meta Platforms performed a spectacular Jekyll and Hyde act, starting the day with a 1.2% gain before dramatically swooning to close down 1.75%. Meanwhile, Apple caught a nasty case of downgrade flu courtesy of Jefferies, with its shares falling 2.25% faster than you can say “Siri, why is my stock tanking?” Not to be outdone, Amazon Prime-delivered disappointment to investors, as Wells Fargo downgraded its shares, resulting in a 3.06% drop. It seems even the mightiest tech trees can be felled by the axe of market skepticism.

Oil’s Surge

In a twist that left investors scratching their heads, oil prices decided to buck the downward trend and surge 3.7% to $77.18 per barrel. This slippery slope upwards was fueled by a cocktail of geopolitical jitters, with tensions between Israel and Iran taking center stage, and Mother Nature throwing a curveball in the form of Hurricane Milton, which intensified to a Category 5 storm. The energy sector, feeling particularly smug, closed .4% higher. Chevron emerged as a winner, with its shares inching up .3% after offloading interests in the Athabasca Oil Sands Project and Duvernay Shale for a cool $6.5 billion.

Fear Index

The CBOE Volatility Index (VIX), often referred to as the “fear index,” closed at $22.64, +17.86% on the day after reaching a high of $22.97 during intraday trading.

Year-to-Date Market Recap

Despite the day’s downturn, major indices have maintained impressive year-to-date gains. The Nasdaq Composite and S&P 500 lead the pack, both boasting a robust 19.4% increase since the start of the year. The Dow Jones Industrial Average and S&P Midcap 400 are neck-and-neck, each up 11.3% YTD. Meanwhile, the Russell 2000 trails but still shows positive momentum with an 8.2% gain. These figures serve as a silver lining, reminding investors that even on turbulent days, the broader market trend remains upward for 2024.

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 $3.73, -1.06%.

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, $2.26, -1.74% & is up +119.42% 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 $1.18, +.85% and is now up +.85% at $1.19 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 its Founder and Chief Scientific Officer, Dr. Michael Newman, will participate as a panelist in an upcoming webinar hosted by Lumanity. The webinar, titled “Adapting to Immuno-Oncology’s R&D Challenges: Refocusing on Innate Immunity as a ‘Next Big Thing’ in Cancer Immunotherapy,” will be held on October 23, 2024. The webinar will explore the next frontier in cancer immunotherapy: harnessing the power of innate immunity. A distinguished panel of biotech leaders will explore strategies for modulating innate immune pathways, either independently or in combination with checkpoint inhibitors, to help patients’ immune systems better control cancer. Dr. Newman will share insights from Indaptus’ pioneering work with its Decoy20 platform, which leverages killed, non-pathogenic Gram-negative bacteria to stimulate both innate and adaptive immune responses. Indaptus’ unique “pulse-prime” approach could offer a new path forward in immunotherapy, targeting hard-to-treat cancers that have not responded to other therapies.

“Immuno-oncology has made significant strides, but we believe that advancing drugs that modulate innate immune pathways in conjunction with adaptive pathway activation will be a critical next step in the evolution of cancer therapy,” said Dr. Newman. “This webinar provides an excellent opportunity to discuss the challenges and opportunities in innate immunity.”

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, $2.49, -6.04%) 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.

On Sept. 19, Eupraxia Pharmaceuticals announced that the Company will be presenting a poster at the upcoming 20th International Symposium on Digestive Endoscopy (“ISDE”) World Congress for Esophageal Diseases to be 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 $7.14, -.56% 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.

On Aug. 1, ADT reported its second quarter results for 2024 that read like a thrilling spy novel, complete with mysterious numbers and covert operations. The company reported a 3% increase in total revenue, reaching $1.2 billion – apparently, securing homes is more lucrative than ever in our paranoid future. Their recurring monthly revenue (RMR) grew by 2% to $355 million, proving that once ADT gets its foot in your door, it’s there to stay

The company boasted “strong customer retention” with a gross revenue attrition of 12.9%, which in ADT speak means they’re only hemorrhaging about 1 in 8 customers. Their “revenue payback” sits at 2.2 years, suggesting it takes that long for customers to stop regretting their decision to sign up.

In a plot twist worthy of a summer blockbuster, ADT’s GAAP income from continuing operations dropped by $54 million. But fear not, shareholders! Their “adjusted” income increased by $3 million. It seems ADT has mastered the art of financial alchemy, turning red numbers green faster than you can say “creative accounting”.

CEO Jim DeVries, channeling his inner motivational speaker, declared that ADT’s success is ‘powered by our employees’ dedication to the proposition that every second counts.” One can only imagine the intense pressure of working in an environment where bathroom breaks are timed to the millisecond.

CalEthos, Inc. (GEDC, $5), a developer of sustainable data center solutions, announced recently the following business update:

On July 24, 2024, CalEthos signed an Option Agreement to purchase 315 acres of land in the soon-to-be approved “Manufacturing Zone” of Lithium Valley. The new property provides CalEthos with significant advantages over its previous data center development site, which include:

Larger, strategically located, industrial-zoned property with acreage for on-site switchyard, substation and additional data center buildings
Better options for connectivity to high-voltage transmission lines
Closer proximity to existing and planned geothermal power plants
Shorter fiber routing distances to internet backbone and communications networks
Directly on the main north/south transportation corridor (Hwy. 111) and gateway entrance (Sinclair Rd.) to the planned 51,000-acre Lithium Valley development area
Lower flood risk – outside of the 100- and 500- year flood zones in a FEMA X (Unshaded) area

CalEthos’ first of three development phases on the property is a planned 100-acre/420-megawatt (MW) campus, with up to 1,000,000 square feet of clean energy powered build-to-suit data centers to support AI, Cloud and Hyperscale customers.

“This new property gives CalEthos the acreage to develop 3 to 4 million square feet of data center over time as more geothermal power plants and other renewable energy and storage solutions come online in and around Lithium Valley”, said Joel Stone, the Company’s President and Chief Operating Officer.

CalEthos has been working over the last couple of years with the County of Imperial, Imperial Valley Economic Development Corp. (IVEDC), Imperial Irrigation District (IID), and geothermal power producers to develop a comprehensive plan that leverages the region’s clean energy resources to support a large-scale data center operation.

“CalEthos has the county’s full support to develop its data centers in alignment with the broader vision for Lithium Valley,” said Chairman Luis A. Plancarte, Imperial County Board of Supervisors. “The sooner CalEthos builds its data centers and utilizes locally produced power for their operations, the sooner our geothermal power producers can expand operations and increase lithium recovery.”

“CalEthos’ energy needs advance the building of additional local transmission, supports adding more sources of clean energy to the grid, and expedites plans for new geothermal power plants, without waiting for new long-distance transmission lines to be built to get power in and out of the area,” added Alex Cardenas, Chairman of IID.

Sean Wilcock, Vice President of IVEDC, emphasized the project’s positive economic impact, stating, “CalEthos’ data center plans accelerate Lithium Valley’s development by providing energy offtake opportunities, creates jobs, and stimulates the local economy. This project is a vital component of the long-term vision for the region and is a testament that Imperial County has the attributes necessary for the green data center industry.”