BriefCast Publishes Transcript: Nasus Pharma NS002 Phase 2 Positive Topline Results Webinar Transcript

In a call hosted recently, Nasus Pharma (NYSE:NSRX) presented strong positive topline results from its Phase 2 clinical study evaluating NS002, its investigational intranasal epinephrine powder for the treatment of anaphylaxis.

The study demonstrated a statistically significant and clinically meaningful advantage over EpiPen in time to therapeutic threshold (T100), with NS002 reaching effective epinephrine levels in a median of 1.69 minutes compared to 3.42 minutes for EpiPen. At 2.5 minutes, 67.4% of participants receiving NS002 had already reached therapeutic levels versus 27.1% with EpiPen, with the advantage persisting through the 5-minute mark.

Across the critical early treatment window, NS002 consistently delivered faster and greater epinephrine exposure compared to intramuscular injection, while maintaining a comparable peak concentration and a favorable safety profile. The study also demonstrated consistent performance under nasal allergic challenge conditions and in repeat dosing scenarios, supporting its potential for real-world use.

With these results, Nasus Pharma highlighted NS002’s differentiated profile and confirmed plans to advance the program toward a pivotal study expected to initiate in the fourth quarter of 2026.

Click here to view the full transcript on briefcast.ai or see below.

New York, March 19, 2026 (GLOBE NEWSWIRE) -- - BriefCast.AI, a leading AI-powered news and transcript distribution brand, today released the transcript and summary for Nasus Pharma’s (NYSE:NSRX) NS002 Phase 2 Topline Results Call.

Full Transcript:

The transcript is available below. The presentation referenced during the call should be available on Nasus Pharma’s investor relations website. We encourage readers to review the full webcast and press release announcing the results.

Operator: Good morning, and welcome to Nasus Pharma’s Conference Call to review the topline analysis from the Phase 2 clinical study of NS002 intranasal epinephrine powder. Currently, all participants are in a listen-only mode. Before we begin, this call and the question-and-answer session that follows could include forward-looking statements within the meaning of the U.S. federal securities laws. For example, we are using forward-looking statements when we discuss: the potentially superior profile of NS002 compared to traditional autoinjectors; and our work towards a pivotal study planned for initiation in the fourth quarter of 2026. Listeners are referred to the full text of the disclaimer published in this morning’s press release. This call is being webcast live and can be accessed on the Investors section of Nasus Pharma’s website, where a replay will be available. I’ll now turn the call over to Dan Teleman, Chief Executive Officer of Nasus Pharma.

Dan Teleman, Chief Executive Officer of Nasus Pharma: Thank you, operator. Good morning, everyone and thank you for joining us today. I’m Dan Teleman, CEO of Nasus, and with me on the call are Dr. Dalia Megiddo, Chief Development Officer, and Eyal Rubin, Chief Financial Officer and EVP. On this call, we will review the topline analysis from the single and repeated dose clinical study of NS002, our intranasal powder epinephrine product candidate. We released the interim analysis back in January. For anyone new to Nasus, we’ll provide a short introduction about the company and our technology, then move onto NS002 and the recent trial results. We’ll then make time for questions and answers before we close the call.
For anyone new to Nasus, we are a clinical-stage pharmaceutical company that leverage its proprietary powder technology called Nasax to develop innovative intranasal products. Our powder formulation is engineered to achieve comprehensive distribution across the nasal cavity, providing an increased absorption surface area. This enables significantly faster drug absorption compared to traditional liquid intranasal formulations. This technological advantage is particularly valuable for emergency medications where speed of onset is critical.

Our lead product candidate is NS002, an intranasal epinephrine powder designed to treat anaphylaxis, a severe and potentially life-threatening allergic reaction that requires immediate treatment. Our Nasax technology is particularly suitable for anaphylaxis because successful treatment is fundamentally dependent on the speed of epinephrine absorption. A plasma concentration threshold of 100 pg/ml is required to effectively initiate the reversal of anaphylactic symptoms, especially its cardiovascular symptoms. The time to reach this therapeutic threshold - known as T100 - is therefore a critical pharmacokinetic parameter when evaluating any epinephrine product, as faster onset could mean the difference between life and death.

The current standard of care for anaphylaxis treatment is the epinephrine intramuscular autoinjector, such as EpiPen. However, despite the critical importance of immediate treatment, studies show that many patients fail to carry or use autoinjectors due to needle phobia, the bulky size of the devices, and hesitation during emergencies. NS002 was addresses these barriers as a needle-free, compact, and easy-to-use alternative. Additionally, NS002's dry powder formulation provides enhanced stability and shelf-life advantages compared to liquid formulations, an important consideration for a medication that must be carried at all times.

While patient convenience is important, healthcare providers prioritize clinical performance above all else. Our market research with board-certified allergists validates the critical importance of the pharmacokinetic advantages NS002 demonstrates. Ninety percent of allergists surveyed ranked speed of onset as either critically or very important when prescribing an epinephrine product. Furthermore, 87% indicated that T100 - time to therapeutic threshold - is either extremely or very clinically meaningful when comparing epinephrine products. This data confirms that NS002's pharmacokinetic profile directly addresses the attributes physicians value most.

Dr. Dalia Megiddo, Chief Development Officer of Nasus Pharma: This Phase 2 study was designed to address feedback from the United States Food and Drug Administration and incorporate learnings from other epinephrine development programs. We enrolled 50 healthy adults with a history of allergic rhinitis to evaluate NS002 under conditions that simulate real-world scenarios such as nasal congestion or the need for a second dose. Each subject therefore received both single and repeat doses of NS002 and EpiPen under normal conditions and then after a nasal allergic challenge - a condition that induces significant nasal congestion mimicking the early stages of an anaphylactic reaction.

This rigorous design allows us to evaluate NS002's performance across the full spectrum of conditions patients may encounter during actual emergencies. In accordance with FDA feedback, we also tested whether a second dose should be administered in the same nostril or in the contralateral nostril. We assessed comprehensive pharmacokinetic, pharmacodynamic and safety parameters throughout the study.

Dan Teleman, Chief Executive Officer of Nasus Pharma: Summarizing the data from the top line analysis, this study demonstrated NS002's differentiated and potentially superior profile compared to traditional epinephrine autoinjectors. We can see rapid and high epinephrine absorption, demonstrated by a shorter T100 and Tmax compared to EpiPen, with more subjects reaching T100 within 5 and 10 minutes compared to EpiPen. The maximum concentration or Cmax was comparable to EpiPen. Pharmacodynamic response of NS002 tracks EpiPen and is within normal physiological limits. And consistently with previous studies, NS002 was well-tolerated, with no serious adverse events reported. Adverse Events were local, mild and self-resolving.

Let's take a closer look at the data. In the critical first 5 minutes following administration, epinephrine absorption with NS002 is both faster and higher than EpiPen - under both normal conditions and nasal congestion. We see consistently higher absorption over time compared to EpiPen. Importantly, even under challenging nasal allergic conditions, NS002 maintains epinephrine levels above the therapeutic threshold, demonstrating the robustness of our Nasax powder platform and differentiating NS002 from other intranasal approaches.

Breaking down these pharmacokinetic parameters, we see that NS002 achieves a maximum epinephrine concentration comparable to EpiPen. However, the critical difference lies in the speed of absorption—NS002 demonstrates a substantially faster Tmax and, most importantly, a T100 that is twice as fast as EpiPen. To put this in perspective, NS002 reaches the therapeutic threshold in a median of 1.69 minutes compared to 3.42 minutes for EpiPen, representing a statistically significant improvement. As our market research confirmed, this rapid onset of action is the most important attribute physicians consider when selecting an epinephrine product.

This data in this figure is particularly compelling: At 2.5 minutes, 67.4% of subjects receiving NS002 had already reached the therapeutic threshold compared to 27.1% with EpiPen, at 5 minutes post-administration, 88.4% of subjects receiving NS002 had reached the therapeutic threshold, compared to only 64.6% with EpiPen. This represents the highest proportion of subjects achieving therapeutic threshold at this early timepoint that we have observed across published data for epinephrine products, whether currently marketed or in clinical development.

We carefully monitor the effects of NS002 on the pharmacodynamic parameters – systolic and diastolic blood pressure and heart rate. Consistent with Epinephrine mechanism of action, we see a transient increase in systolic blood pressure and heart rate. The increase is tracking well with that of EpiPen and always with normal physiological conditions.

Moving on to repeat dosing. We can see in both normal and under nasal allergic challenge, NS002 provides equivalent or better absorption of epinephrine compared to EpiPen.
NS002 absorption consistently exceeds EpiPen performance and, importantly, is independent of which nostril is used for administration—a key finding for real-world use where patients experiencing anaphylaxis may require a second dose. This consistent performance across dosing scenarios is particularly significant, as up to 20% of anaphylactic reactions may require repeat epinephrine administration.

Looking at the individual pharmacokinetic attributes with repeat dosing, we have a comparable Cmax, a comparable Tmax and as before, a considerably faster T100.

Consistent with previous studies, NS002 administration is safe and tolerable, with no serious adverse events reported. Most Adverse Events were localized and self-resolving, with the overwhelming majority classified as mild.

To summarize, the topline results of this Phase 2 study comparing NS002 intranasal epinephrine powder to EpiPen has demonstrated that NS002 possesses a differentiated and potentially superior profile compared to traditional autoinjectors, with performance attributes that directly address the clinical needs identified by physicians.

First, across all conditions tested - including repeat dose and nasal allergic challenge - NS002 reached the therapeutic epinephrine threshold twice as fast as EpiPen, with a median T100 of 1.69 minutes versus 3.42 minutes. This rapid onset of action is the most important attribute allergists consider when comparing epinephrine products.

Second, we observed that 88.4% of subjects receiving NS002 achieved the therapeutic threshold within 5 minutes, compared to 64.6% with EpiPen - representing the highest early achievement rate in published epinephrine product data.

Third, in the critical 10-minute therapeutic window, NS002 achieved 50% higher total epinephrine absorption compared to EpiPen, potentially enabling faster symptom resolution when every second counts.

Finally, NS002 demonstrated a favorable safety profile consistent with previous studies, with no serious adverse events reported. Based on these compelling results, we are advancing NS002 toward a pivotal study planned for initiation in the fourth quarter of 2026. We look forward to continuing to update you on our progress as we work to bring this potentially life-saving innovation to patients. We believe NS002 represents an important strategic asset for the company and, if successfully developed, has the potential to drive meaningful long-term value for our shareholders and other stakeholders.

And with that, we're happy to take your questions. Operator?

[Note: Q&A not included in this summary but took place on the call]

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