Company Description

We are a clinical-stage specialty pharmaceutical company focused primarily on the development of intranasal drugs to treat emergency medical conditions. Intranasal administration is especially suitable for medical emergencies when prompt drug administration is critical, since the nose is lined up with a very rich vascular bed enabling quick drug absorption. We are developing a unique powder-based intranasal technology, or PBI, with a specialized product portfolio to address acute medical conditions and public health threats. We believe that PBI may be superior over liquid-based solutions due to potentially significantly higher dispersion of powder throughout the nasal cavity, thus creating a larger absorption area and enabling more rapid and higher drug absorption. In addition, the uniform spherical powder particles of our proprietary formulation may enhance the consistency and reliability of the delivered dose. The initial clinical trials of our PBI products involving different molecules performed thus far have demonstrated quicker and higher drug absorption over similar solution-based nasal products. However, to date we have only tested our product candidates on a relatively small patient population and none of our products have been approved by the Food and Drug Administration, or the FDA. Prior to obtaining FDA approval of any of our product candidates, we will need to perform additional clinical testing of our product candidates to confirm any benefits and advantages our products may have over similar nasal products. Our mission is to offer better protection to patients during acute, severe and life-threatening medical conditions by an effective, user-friendly and immediately active PBI specialized products. To help achieve this we are focused on developing NS002, an intranasal powder Epinephrine nasal spray for the treatment of type 1 severe allergies and anaphylaxis, or Intranasal Epinephrine, and we also have been developing NS001, an intranasal Naloxone powder nasal spray for the treatment of opioid overdose, or Intranasal Naloxone, however we currently paused our work on NS001 and plan to pursue partnering opportunities for further development of NS001. We will need to obtain regulatory approval for our products in order for us to grow our business. We currently have no FDA approved products. Our products have been tested on relatively small patient populations thus far. Obtaining regulatory approvals and developing NS002 and NS001 will require the incurrence of significant costs and our success will depend, in part, on gaining market acceptance. In order to gain market acceptance in the United States, we will require specific approval from the FDA for our product candidates. We intend to seek approval of NS002 as an approved molecule and a new delivery route (with EpiPen autoinjector as the reference device) under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, or FFDCA, which allows the applicant to rely in part on previous studies conducted by unrelated parties, such as another drug manufacturer, and existing sources including published literature, for marketing approval by the FDA in the United States, and will seek approval under the comparable hybrid application pathway in the European Union, or the EU. The FDA may not agree that our product candidates satisfy the requirements for the Section 505(b)(2) regulatory approval. Such abbreviated approval pathways may not lead to a faster development or review process compared to traditional approval pathways and do not increase the likelihood that NS002 or NS001 will receive regulatory approval in the United States or the EU. To date, we have conducted a twelve-patient pilot study of NS002, which included the testing of bioavailability of Epinephrine under “allergenic challenge” - the creation of severe acute allergic reaction in the nose by inserting ascending doses of allergens to the nose of the healthy volunteers with known allergic rhinitis included in the study. The results showed that Epinephrine intranasal delivery of our NS002 followed the established characteristics of our platform technology, namely, there were higher levels of the drug in the plasma in situations where immediate administration could be lifesaving. The Phase 2 portion of our NS002 study included twelve patients and the trial was not powered for statistical significance. In trials not powered for statistical significance, there is a high chance that observed effects may not be accurate due to small sample size. The Phase 2 study, which is meant to optimize the dose that will be used in the Phase 3 study for registration, is conducted in limited patient populations to identify possible adverse effects and safety risks, to preliminarily evaluate the dosage tolerance of the product for specific targeted diseases or conditions and to determine dosage tolerance, optimal dosage and dosing schedule. Our Phase 2 study is aimed at defining the final clinical dose to be used in our powder Epinephrine product candidate, compared to the bioavailability of Epinephrine following a various dosing of NS002 Microspheres Epinephrine powder. The pharmacokinetic, or PK, results of our Phase 2 study are in line with the known attributes of our nasal powder technology, namely: immediate absorption of Epinephrine and reaching higher peak plasma Epinephrine levels quicker compared to intramuscular, or IM, Epinephrine injections. We intend to perform two additional Phase 2 studies of NS002. The first will be aimed at determining whether, if necessary, during a real-life anaphylaxis a second dose of NS002 should be administered in the same nostril as the one used for the first administration of NS002 or whether it should be in the other nostril. The second Phase 2 study will test the “carry-over effect,” or whether the first dose of Epinephrine changes the absorption of Epinephrine of a following dose. Each study is currently planned to include at least 12 healthy volunteers with allergic rhinitis. Prior to submission to the FDA for marketing approval, we also intend to perform a pivotal clinical, or Phase 3, study that will include a subsection of self-administration. We also intend to separately perform: (1) stability testing which involves testing the product candidate under various temperature and humidity points; (2) a reliability study, which is a subset of the stability study that tests the NS002’s administration device in several potential conditions; (3) a usability study, which tests how user friendly the device is; (4) preclinical studies or short animal safety studies in two animal species; and (5) a pediatric study, the details of which will be agreed upon with the FDA as we progress with the program. With respect to NS001 Intranasal Naloxone, we have performed a pilot study, which is a first in human study aimed at safety and bioequivalence, and pivotal clinical study, which is the Phase 3 registration study, in 14 and 42 healthy volunteers, respectively, with the objective of evaluating the comparative bioavailability of Naloxone between NS001 and certain competitor products. The pilot study results were submitted to the FDA in support of the progression to the pivotal study. While the pilot study was not powered for statistical significance, the results suggested our technology demonstrated a faster absorption rate in the immediate critical period after administration. This finding was further supported by the pivotal clinical, or Phase 3, which was powered for statistical significance and confirmed the enhanced absorption profile. The Phase 3 study included an expanded patient population to further evaluate dosage and clinical efficacy. Our pivotal clinical study consistently showed an advantage in the first 30 minutes after administration. As of the date of this prospectus, we currently intend to focus our development and regulatory approval efforts on our Intranasal Epinephrine and other preclinical programs and plan to pursue partnering opportunities for further development of NS001. Our platform technology can also be incorporated into other products as it has been tested with several additional preclinical and invitro molecules based on our proprietary nasal powder formulation and technology. In addition to our two main products, Intranasal Epinephrine and Intranasal Naloxone, we are exploring other potential indications for which our PBI technology may be applicable, including: NS005, an intranasal midazolam powder nasal spray for the treatment of acute seizures, or Intranasal Midazolam; NS004, an intranasal atropine powder nasal spray for the treatment of organophosphate poisoning, or Intranasal Atropine; and NS003, an intranasal ondansetron powder nasal spray for the treatment of intractable vomiting, or Intranasal Ondansetron. Competition in the pharmaceutical industry is intense. Some of our competitors hold significant market share, have long histories and strong reputations within the industry, greater brand recognition, and more financial and human resources than we do. They also have more experience and capabilities in researching and developing testing devices, obtaining and maintaining regulatory clearances and other requirements, manufacturing and marketing those products than we do. Their dominant market position and significant control over the market could significantly limit our ability to introduce or effectively market and generate sales of NS002 or NS001. To date, we have incurred significant operating losses, generated no revenues from existing products, and as of December 31, 2024, our accumulated deficit was $12.7 million. We expect that we will need to raise substantial additional funding in the future. We are an Israeli corporation and were incorporated in Israel in May 2019 under the name Nasus Pharma Ltd. Our principal executive offices are located at Yigal Alon 65, Tel Aviv, Israel 6744317. Our telephone number is +972.3.573.6632. Our website address is www.nasus-pharma.com.