Hello Everyone,
We have a past winner back on our radar for tomorrow'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.
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 term sheet to merge with Kadimastema 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 Binding Term Sheet to Merge
The proposed transaction will create a Nasdaq-traded, biotechnology company with product candidates in advanced stages of clinical development and focused on advancing Kadimastem's allogeneic cell therapy platform
Each of Kadimastem and NLS Pharmaceutics has received commitments of support for the transaction from shareholders representing more than 40% of their respective outstanding shares
ZURICH, SWITZERLAND and NESS ZIONA, ISRAEL / ACCESSWIRE / July 29, 2024 / NLS Pharmaceutics Ltd. (NASDAQ:NLSP) ("NLS"), a biopharmaceutical company. and Kadimastem Ltd ("KDST.TA", "Kadimastem"), a clinical-stage cell therapy company developing and manufacturing "off-the-shelf" allogeneic cell products for the treatment of neurodegenerative diseases and potential cure of diabetes, announced today that they have entered into a binding term sheet for a transaction under which Kadimastem is anticipated to become a wholly owned subsidiary of NLS, and Kadimastem's shareholders will acquire an 85% interest in NLS (the "Transaction"). Upon completion of the Transaction, which is subject to, among other things, approval by NLS and Kadimastem stockholders, the combined company is expected to operate under the name Kadimastem and be traded on the Nasdaq Capital Market. Under the proposed terms, existing Kadimastem shareholders will hold 85% of the issued and outstanding shares of the merged company and the existing shareholders of NLS will hold the remaining 15% of the issued and outstanding shares of NLS.
About the Proposed Transaction
The proposed Transaction will be affected through a reverse triangular structure in which Kadimastem will become a wholly owned subsidiary of NLS. In consideration, NLS will issue its shares to the Kadimastem shareholders who, after completing the Transaction, will hold 85% of the issued and outstanding shares of NLS, and the existing shareholders of NLS will hold the remaining 15% of NLS.
The Transaction is subject to approval by Nasdaq and is structured so that NLS will remain an SEC reporting company whose shares are listed on the Nasdaq Capital Market. All but one of the NLS officers and directors is expected to resign from their positions at NLS.
Following the Transaction, the parties expect to continue developing NLS's promising, first-in class Dual Orexin Agonist platform ("DOXA") within the merged company. The remaining NLS assets are expected to be divested subject to a contingent value rights ("CVR") agreement, the proceeds of which will be distributed entirely to the current shareholders of NLS.
At the closing of the Transaction, Kadimastem will be required to have $3.5 million of cash on hand and NLS will be required to have $0.6 million of cash on hand.
The binding term sheet has been approved by the boards of directors of both companies. The definitive agreement will include customary closing conditions, including certain regulatory approvals, and approval from the shareholders of both NLS and Kadimastem Each of Kadimastem and NLS has received commitments of support for the Transaction from shareholders representing more than 40% of its outstanding shares.
In addition, as a condition to the consummation of the Transaction, the liabilities of NLS to its vendors and insiders will be settled and removed from its balance sheet.
The definitive agreement is expected to be executed in September 2024. The Transaction is expected to close before December 31, 2024.
‟We are pleased to be working together with Kadimastem as our pipelines hold significant synergies, especially in the area of diabetes which is often associated with sleep-wake dysregulation manifesting as insomnia, excessive daytime sleepiness and altered sleep architecture,″ said Alex Zwyer, Chief Executive Officer of NLS. ‟The merger with Kadimastem reflects the continued commitment of our management team and board of directors to deliver long-term value to our stockholders. In particular, NLS shareholders will have the opportunity to benefit from the equity of the merged company and, through the contingent value rights agreement, from the value of our legacy assets, including Mazindol.″
Professor Michel Revel, Kadimastem's CSO said, "I'm thrilled about this merger, and believe the combined company presents a great opportunity to enhance our portfolio and product candidates. In the past, I had the privilege of working on a medicine for multiple sclerosis, Rebif®, taking it from the lab to the market and transforming it into a blockbuster product. Similarly, I see tremendous potential here to develop our AstroRx® product candidate for ALS patients, as well as advancing our diabetes product IsletRx. Together with the assets from NLS. The completion of the Transaction is expected to promote and expand the development of Kadimastem's groundbreaking technological platform."
Ronen Twito, Kadimastem's Executive Chairman and President, commented, "The merger with NLS will enhance our visibility to the market as a Nasdaq listed company and strengthen our portfolio with the addition of DOXA. Moreover, as previously reported, our AstroRx® product candidate for Amyotrophic Lateral Sclerosis, also known as ALS, treatment received FDA approval for a Phase IIa multi-site clinical trial in the U.S.In addition, our joint development of a diabetes product with iTolerance, a U.S.-based company, proceeding towards pre-Investigational New Drug submission to the FDA. We believe that the exposure of the merged company to the U.S. capital markets will enable us to develop the company's clinical assets and increase shareholder value."
About Kadimastem
Kadimastem is a clinical stage cell therapy company whose shares are listed on the Tel Aviv Stock Exchange "KDST.TA". Kadimastem is 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®, Kadimastem‘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 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.
Kadimastem was founded by Professor Michel Revel, CSO of Kadimastem, who is 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 drug sold worldwide.
Please Read the Full Profile Here: https://insiderfinancial.com/newalert
Sincerely,
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