By John Vandermosten, CFA
NYSE:NSRX
READ THE FULL NSRX INITIATION RESEARCH REPORT
We are initiating coverage of Nasus Pharma Ltd. (NYSE:NSRX) with a valuation of $19.00 per share. This value is based on our estimates for successful development and commercialization of NS002 in patients requiring emergent care for anaphylaxis in the United States and in developed regions throughout the globe. Epidemiological estimates suggest from 14,000 to 200,000 emergency room visits for anaphylaxis and severe allergic reactions per year in the United States. However, the at-risk population is substantially larger with 1% to 3% of the population, or 3.5 to over 10 million people, susceptible to anaphylaxis due to allergies or sensitivities. The prevalence of anaphylaxis has increased over time with one source measuring a 3% increase from 2004 to 2016. The population susceptible to severe allergic reaction is much greater than the number of reported cases and many at risk fail to carry emergency epinephrine due to a variety of factors.
Emergency treatment for anaphylaxis has remained relatively constant from the late 1980s until 2024, with injectable epinephrine representing the standard of care. A liquid nasal formulation was approved in 2024, expanding the breadth of treatment modalities. However, approved approaches present a number of shortcomings. Nasus’ powder-based intranasal technology is designed to address these weaknesses by eliminating needles, reducing device size, improving stability and shelf life, and enabling rapid, efficient drug delivery.
NS002 is a powder-based formulation of epinephrine engineered for broad disposition to all parts of the nasal cavity, allowing for faster delivery and greater early absorption in the plasma relative to approved methods. EpiPen had been the standard of care for anaphylaxis emergency treatment for many years. It is still used widely, despite needle injury risk, bulky form factor, dosing uncertainty, limited shelf life and limitations on speed of delivery. To address these issues, new formulations were developed including sublingual and liquid nasal delivery; however, they presented other weaknesses. NS002 seeks to address these with a powder-based formulation that provides rapid delivery, stability and an efficient form factor.
Epinephrine, also known as adrenaline, is both a natural hormone produced by the adrenal glands and a neurotransmitter. It drives the body's fight-or-flight emergency response. As a medication, it is the primary, life-saving treatment for anaphylaxis or severe allergic reactions. It reverses symptoms by relaxing airway muscles, increasing blood pressure and heart rate, and dilating airways for easier breathing. It also has an effect on metabolism by increasing blood sugar and accelerating blood supply to muscles. It helps the body respond rapidly to threats. When a person is suffering from anaphylaxis, epinephrine acts as a vasoconstrictor and bronchodilator, rapidly reversing severe allergic reactions to food, medication or insect stings. Side effects can include a racing heart, anxiety or shakiness.
Nasus has completed a Phase II pharmacokinetic (PK) and pharmacodynamic (PD) study that compared NS002 against standard of care and is expected to start a pivotal study later this year. The Phase II PK/PD study produced a faster time to target concentration of 1.69 minutes compared to 3.42 minutes for EpiPen. The study also exhibited quicker time to TMAX and to target concentrations at set time points. NS002 is being readied for a pivotal study slated to begin enrollment in 4Q:26. The task will be relatively quick. 70 to 100 healthy patients will be enrolled at a single site with evaluations complete and a readout by 1Q:27. A 505(b)(2) application is expected in 2H:27 with a response expected by the FDA about one year later.
While the majority of Nasus’ funding and management focus are centered on the NS002 program, the company has three preclinical products in its pipeline with identified indications. The first, designated NS003, is preparing for first in-human studies of ondansetron for nausea and vomiting later this year. NS004 is in development to evaluate an unidentified molecule for metabolic conditions and NS005 is an unidentified molecule intended for a cardiovascular indication. We do not include these assets in our valuation.
Perhaps more than 10 million individuals are at risk of anaphylaxis in the United States; however, only 10 to 15% of these individuals present at the emergency room. Many occurrences are far from emergency services and can be treated locally with epinephrine. Anaphylaxis is a severe, systemic allergic reaction that typically involves multiple organ systems simultaneously. Symptoms usually develop in a few minutes to hours after exposure to a trigger. Hives, itching and swelling occur in many cases while respiratory and cardiovascular symptoms are also common. Cardiovascular responses are a major cause of anaphylaxis death, especially cardiac arrhythmia.
Nasus’ balance sheet listed cash of $4.3 million as of December 31st, 2025 which was augmented by a $15 million private placement executed in February. The low cost of the pivotal trial allows existing cash to support operations into the middle of 2027 and the submission of its new drug application (NDA).
Nasus has developed its supply chain so that a partner may easily absorb these operations. Nasus intends to partner with or sell to established pharmaceutical companies to commercialize NS002. Beyond the primary market in the United States, it has also identified Japan, the European Union and Brazil as attractive destinations. We believe that the management team is developing relationships with potential partners that will crystallize as more data is released and the regulatory path is closer to complete. The market size for the global epinephrine market is from $2.5 to $3.0 billion with about two-thirds of this total generated in the United States. We think that Nasus’ intranasal powder delivery product can attract material share in this market as it addresses shortcomings present in other methods of administration and provides faster delivery and greater plasma concentrations that other products in the market.
Key reasons to own Nasus’ shares:
- Existing anaphylaxis treatment presents multiple shortcomings
- Exposure to needle discomfort or phobia
- Limited shelf life for liquid-based products
- Existing products are too slow to achieve meaningful plasma concentration benchmarks
- Form factor is large and bulky
- Distribution of epinephrine not optimized
- NS002 approaching its pivotal trial
- Forecasted trial start in 4Q:26
- Trial readout expected in 1Q:27
- New drug application submission anticipated in 2H:27
- Nasax delivery platform targets a rapid and precise delivery of drug to blood plasma and brain
- Intranasal delivery
- Powder formulation comprised of uniform spherical API using approved carrier
- NS002 delivered using Aptar’s FDA approved Unit Dose Spray device
- Pipeline offers other clinical indications
- NS001: naloxone for opioid overdose
- NS003: ondansetron for nausea & vomiting
- NS004: metabolic indications
- NS005: cardiovascular indications
- Robust intellectual property
- Patent for epinephrine dry powder formulation expires in 2038
- Eligible for patent term extension
In the following sections we describe anaphylaxis, how it occurs and its implications for health and mortality. The report examines the etiology of the condition and how often it occurs in the United States and around the world. We then discuss anaphylaxis’ risk factors, symptoms, diagnosis, standard of care and prognosis. We move on to describe the drug epinephrine, its chemical composition and class. We look at the approved formulations and delivery devices for the drug and identify the related shortcomings of alternate delivery approaches and how NS002 addresses them.
We summarize the company’s pipeline including the lead candidate NS002 and the programs pursuing other indications. NS002 development history is presented, including a summary of pharmacokinetic and pharmacodynamic (PD) and dose finding studies along with a look ahead to the pivotal study. The next section reviews Nasus’ intellectual property and summarizes several of its most important patents. The report explores peers and competitors highlighting other companies with nasal delivery technologies and anaphylaxis treatment products. This is followed by recent milestones, a brief corporate history and financial results for Nasus Pharma. We then introduce key management team members and highlight the risks faced by the company. The closing section provides our valuation discussion and details the assumptions behind our target price. Our work generates a valuation of $19.00 per share for Nasus Pharma Ltd.
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