Hello Everyone,
There is no doubt that small caps are back.
We have been waiting for this moment.
The Russel 2000, which is the benchmark index for small caps is up 12% YTD and 15% over the past year.
If that isn't proof enough just look at the companies we have profiled over the past 60 days.
We don't need to look further than yesterday.
The Biotech that we brought to your attention Tuesday night closed at 1.37 that session. Yesterday it hit 1.81 after opening at 1.42 for a clean 25% move north during the session. Keep watching that one, but we have a time sensitive situation that we want to bring to your attention for today's session.
This one exploded double digits the last time we took a look at it.
Since the last time we looked at it the company completed a 1-40 reverse split, wiping the float down to a mere fraction of what it was.
Pull up NLSP right away.
They just dropped huge news this morning that is getting major traction,
NLSP is a clinical-stage pharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system, or CNS, disorders, who have unmet medical needs.
The global ADHD market is expected to reach over US$ 70 billion by 2032 growing significantly in the coming years, fueled by rising diagnosis rates and demand for innovative treatments. And amid this growing need, NLSP is making impressive progress with a promising drug that targets not only ADHD but also closely linked sleep-wake disorders.
Their lead candidate is Mazindol ER. This one is Phase 3-ready for ADHD as well as for narcolepsy, also targeting excessive daytime sleepiness—a major unmet need in worldwide that is projected to grow at nearly 10% annually.
With a proven safety profile from prior use as an appetite suppressant, Mazindol ER has the potential to move efficiently through the regulatory pipeline. NLSP has also positioned itself with a clean balance sheet, recently regaining full Nasdaq compliance and clearing all debt while raising $3.2M and with a 12-month cash runway and a binding terms sheet for a merger with Kadimastema, a larger company that has an executive team with experience taking products from the lab to the market.
IsletRx is Kadimastem's treatment for diabetes. IsletRx is comprised of functional pancreatic islet cells producing and releasing insulin and glucagon. IsletRx is intended to treat and potentially cure patients with insulin-dependent diabetes.
CNS disorders are a diverse group of conditions that include neurological, psychiatric, and substance abuse disorders. Their discovery platform currently focuses on single molecules that function through multiple mechanisms designed to target the complexity of the CNS disease state. They believe that this approach may potentially offer new treatment options for patients, including those who are refractory to currently available treatments. Their current focus is in the therapeutic areas of rare hypersomnia disorders (conditions characterized by excessive daytime sleepiness, or EDS, such as narcolepsy) and complex neurodevelopmental disorders. Their drug development pipeline features our lead product candidate, Quilience®, for the treatment of EDS and cataplexy associated with narcolepsy, and our follow-on drug candidate Nolazol®, for the treatment of ADHD
COMPANY HIGHLIGHTS
- Mazindol ER has successfully completed a Phase 2 trial, including OLE, for narcolepsy treatment: projected to be $4.5B annual market by 2027**
- Orphan Drug Designation (ODD) granted in the US and Europe
- AMAZE phase 3 program starting in July 2023, secured funding for current projects and existing operations through 2025. Development of Mazindol ER is in the spotlight for progression purposes, particularly for the treatment of EDS and cataplexy in adult patients who suffer from narcolepsy
- Named Patient Program for patients suffering from idiopathic hypersomnia launched in target markets across Europe
- Key Executive Leadership roles filled
- Pipeline progressed and expanded with long-dated IP protections in major markets
- Over 100 patents in over 140 countries including technology and application for a variety of diseases such as ADHD, Cancer Fatigue, Parkinson's and more. Not to mention that several products are nearing the end of Phase 2 and approaching NDA filing
- POLARIS: Mazindol ER Phase 2 Program in Narcolepsy, consisted of two US clinicaltrials approved by the FDA, met its primary endpoint with high statistical significance and demonstrated a favorable safety and tolerability profile. These results were promising, i.e, Sustained EDS and cataplexy improvements at all time points. OLE conclusions: 6-month OLD, displayed good subject participation (87%) and retention (11.5%)
- Partnership with Université de Lausanne (UNIL) (preclinical projects), University of Berne (narcolepsy reserach), Swiss Narcoslpsy Network (narcolepsy reserach) ( (BVF Partners L.P (financial partnership)
- Partnerships with Patient advocacy groups including Narcolepsy Network, The Narcolepsy Foundation, The Sleep Consortium, Hypersomnia Foundation, and Wake Up Narcolepsy
NLS Pharmaceutics and Kadimastem Announce the Submission of a Request by Kadimastem and iTolerance, Inc. for an FDA Pre-IND Meeting for an Innovative Breakthrough Type 1 Diabetes Treatment
This submission comes after successful INTERACT meeting with the FDA earlier this year.
- NLS Pharmaceutics and Kadimastem working to close merger by the end of January 2025
ZURICH, SWITZERLAND AND NESS ZIONA, ISRAEL / ACCESSWIRE / December 19, 2024 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP) and Kamimastem Ltd. ("Kadimastem"), a clinical-stage company specializing in "off-the-shelf" allogeneic cell therapy products for neurodegenerative diseases and diabetes, announced today in collaboration with iTolerance, Inc, ("iTolerance") a Miami-based regenerative medicine company, that a request for a Pre-Investigational New Drug ("Pre-IND") meeting has been submitted by Kadimastem and iTolerance to the U.S. Food and Drug Administration ("FDA") for iTOL102, an investigational biologic consisting of allogenic human stem cell-derived pancreatic islets combined with an immunomodulator for the treatment of Type 1 Diabetes. Kadimastem believes that this collaboration signifies a potentially transformative step in diabetes treatment.
This submission comes after a successful INTERACT ("Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products") meeting, which is a meeting at a specific time early in the product development, between Kadimastem, iTolerance, and the FDA earlier this year. The submission is a significant milestone toward the clinical development of iTOL102, an on-going collaborative research initiative between iTolerance and Kadimastem, funded in part by the Israel-United States Binational Industrial Research and Development Foundation("BIRD"). iTOL102 combines iTolerance's proprietary SA-FasL microgel (known as iTOL-100), an immune modulator, and IsletRx, insulin-producing islet cells derived from human pluripotent stem cells, to generate an innovative treatment intended for the potential cure of type 1 diabetes.
iTOL-100, an immunomodulatory microgel technology being developed by iTolerance is designed to reduce or eliminate the need for life-long chronic systemic immunosuppression following transplantation of allogenic cells. In a preclinical diabetic rodent model designed by iTolerance, iTOL-100 was shown by iTolerance to be compatible with Kadimastem's IsletRx human stem cell-derived islets.
Kadimastem's IsletRx is a clinical-grade product comprising human pancreatic islet-like cells capable of secreting insulin. IsletRx, a preparation of human stem cell-derived islets developed by Kadimastem, is a scalable and virtually unlimited source of insulin-producing cells which could address the critical shortage of donor islets for transplantation. This innovative therapy may effectively detect glucose levels in the body and produce the necessary amounts of insulin and glucagon.
The iTOL102 product was evaluated at the fast-track center for testing at the Diabetes Research Institute ("DRI") at the University of Miami School of Medicine, where it was designated by DRI to be a novel combination of tolerance-inducing agent and human stem cell-derived islets demonstrating functional insulin release and disease reversal in an animal model.
Ronen Twito, Executive Chairman and Chief Executive Officer of Kadimastem, stated, "This requested Pre-IND meeting is a crucial step in our development of iTOL 102 and towards bringing this potential breakthroughtherapy to the market. We are committed to advancing our innovative IsletRx cell product and are excited about the potential of combining it with iTolerance's immunomodulatory technology to create a potential cure for Type 1 diabetes."
iTolerance Chief Executive Officer, Dr. Anthony Japour, added, "The submission of a request for a Pre-IND meeting with the FDA underscores our commitment to addressing the critical need for a diabetes cure with an off-the shelf human allogenic stem cell-derived pancreatic islet product together with iTolerance's proprietary immunomodulator, iTOL-100, that may reduce or obviate the need for life-long immunosuppression following transplantation. By working closely with Kadimastem, we believe we can unlock the potential for cell therapies for the treatment, and potential cure of Type 1 diabetes."
Alexander Zwyer, Chief Executive Officer of NLS Pharmaceutics, commented, "We are confident that our pending merger with Kadimastem, once completed, will add significant value to the combined company's pipeline, bringing valuable assets and a promising growth trajectory. We are working toward the merger closing by the end of January and remain optimistic about the positive impact it will have on our future."
As previously reported, NLS Pharmaceuticals and Kadimastem entered into an agreement and plan of merger in November 2024. The merger is subject to closing conditions, including the approval of the shareholders of each of the NLS Pharmaceutics and Kadimastem.
About Kadimastem
Kadimastem is a clinical stage cell therapy company, developing "off-the-shelf", allogeneic, proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells. AstroRx®, the company's lead product, is an astrocyte cell therapy in clinical development for the treatment for ALS and in pre-clinical studies for other neurodegenerative indications.
IsletRx is the company's treatment for diabetes. IsletRx is comprised of functional pancreatic islet cells producing and releasing insulin and glucagon, intended to treat and potentially cure patients with insulin-dependent diabetes. Kadimastem was founded by Professor Michel Revel, Chief Scientific Officer of Kadimastem and Professor Emeritus of Molecular Genetics at the Weizmann Institute of Science. Professor Revel received the Israel Prize for the invention and development of Rebif®, a multiple sclerosis blockbuster drug sold worldwide. Kadimastem is traded on the Tel Aviv Stock Exchange (TASE: KDST).
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