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Nasus Pharma Advances NS002 Towards Pivotal Study Following Positive Phase 2; Reports Annual Results and Provides Business Update
Globenewswire· 2026-03-25 13:00
Core Insights - Recent Phase 2 topline results indicate NS002's potential for best-in-class epinephrine delivery, showing statistically significant improvements in early absorption compared to EpiPen®; a pivotal study is planned for Q4 2026 [1][6] - The company is advancing pipeline assets NS003 (Ondansetron for chemotherapy-induced nausea and vomiting) and NS004 (metabolic disorders) toward first-in-human studies expected to start in the second half of 2026, expanding its intranasal product portfolio into high-value therapeutic areas [1][4] - The company is well-funded through the planned NS002 pivotal study and potential NDA submission, with cash, cash equivalents, and marketable securities of $4.3 million as of December 31, 2025, up from $0.3 million in 2024 [7] Business Update - NS002 is an intranasal powder formulation of epinephrine for anaphylaxis, demonstrating significant improvements in time to therapeutic threshold (T100) and a higher proportion of participants reaching therapeutic levels quickly compared to EpiPen® [6] - The pivotal clinical study for NS002 is expected to initiate in Q4 2026, with a readout planned for Q1 2027, subject to regulatory alignment [6] - The company is also advancing NS005, targeting cardiovascular diseases, alongside NS003 and NS004 [2][6] Financial Results - Research and development expenses for the year ended December 31, 2025, were $2.4 million, compared to $0.3 million in 2024, primarily due to NS002 development costs [8] - General and administrative expenses increased to $2.7 million in 2025 from $0.7 million in 2024, attributed to the transition to a public company [9] - The net loss for the year ended December 31, 2025, was $5.9 million, compared to a net loss of $1.5 million in 2024, with 9,015,383 shares outstanding as of December 31, 2025 [9]
BriefCast Publishes Transcript: Nasus Pharma NS002 Phase 2 Positive Topline Results Webinar Transcript
Globenewswire· 2026-03-19 14:06
Core Insights - Nasus Pharma presented strong topline results from its Phase 2 clinical study of NS002, an intranasal epinephrine powder for treating anaphylaxis, demonstrating a significant advantage over EpiPen in time to therapeutic threshold [1][4]. Study Results - NS002 achieved effective epinephrine levels in a median of 1.69 minutes, compared to 3.42 minutes for EpiPen, with 67.4% of participants reaching therapeutic levels at 2.5 minutes versus 27.1% for EpiPen [2][18]. - The study showed NS002 consistently delivered faster and greater epinephrine exposure compared to intramuscular injection, while maintaining a comparable peak concentration and a favorable safety profile [3][16]. Clinical Performance - The Phase 2 study involved 50 healthy adults and evaluated NS002 under real-world conditions, including nasal congestion and repeat dosing scenarios, confirming its potential for practical use [14][15]. - NS002's pharmacokinetic profile demonstrated a T100 that is twice as fast as EpiPen, with 88.4% of subjects achieving the therapeutic threshold within 5 minutes compared to 64.6% for EpiPen [19][25]. Safety Profile - NS002 was well-tolerated with no serious adverse events reported, and most adverse events were mild and self-resolving, consistent with previous studies [16][23]. Future Plans - Based on the compelling results, Nasus Pharma plans to advance NS002 toward a pivotal study expected to initiate in the fourth quarter of 2026, highlighting its potential as a strategic asset for the company [4][27].
What's Going On With Nasus Pharma Stock On Wednesday
Benzinga· 2026-03-18 15:11
Core Insights - NS002 has shown potential to outperform EpiPen in terms of therapeutic threshold achievement, with a median time of 1.6 minutes to reach the critical 100 pg/mL epinephrine threshold [1] - The Phase 2 study results indicate a favorable safety profile for NS002, with no serious adverse events reported [2] Group 1: Study Results - At the five-minute mark, 88.4% of subjects receiving NS002 reached the epinephrine threshold compared to 64.6% with EpiPen [2] - Interim data from January showed that 91% of participants administered NS002 reached the 100 pg/mL threshold at 5 minutes, while only 67% of EpiPen users did [2] - NS002 demonstrated a higher mean peak plasma concentration (Cmax) of 655 pg/mL compared to 548 pg/mL for EpiPen [3] Group 2: Stock Performance - Nasus Pharma's stock is currently trading 45.1% below its 20-day simple moving average (SMA) and 60.1% below its 100-day SMA, indicating significant weakness [4] - Over the past 12 months, shares have decreased by 66.18%, positioning them closer to their 52-week lows than highs [4] - As of Wednesday, shares were down 5.02% at $2.65, near the 52-week low of $2.60 [6] Group 3: Technical Indicators - The RSI is at 28.58, indicating oversold territory and suggesting potential undervaluation in the short term [5] - The MACD is at -0.5581, below its signal line of -0.4248, indicating bearish pressure on the stock [5] - The combination of oversold RSI and bearish MACD suggests mixed momentum, with the overall trend remaining negative [5]
Nasus Pharma (NYSEAM:NSRX) Update / briefing Transcript
2026-03-16 13:02
Summary of Nasus Pharma Conference Call Company Overview - **Company**: Nasus Pharma - **Product**: NS002, an intranasal powder epinephrine product candidate designed to treat anaphylaxis - **Technology**: Proprietary powder technology called Nasax, which enhances drug absorption compared to traditional liquid formulations [2][3] Industry Context - **Current Standard of Care**: Epinephrine intramuscular auto-injectors (e.g., EpiPen) are commonly used for anaphylaxis treatment, but many patients do not carry them due to needle phobia and device bulkiness [4] - **Market Research Insights**: 90% of allergists prioritize speed of onset when prescribing epinephrine products, with 87% considering T100 (time to therapeutic threshold) clinically meaningful [4][5] Key Findings from Phase 2 Study - **Study Design**: Involved 50 healthy adults with allergic rhinitis, assessing NS002 under normal conditions and nasal congestion [6] - **Pharmacokinetic Results**: - NS002 achieved T100 in a median of 1.69 minutes compared to 3.42 minutes for EpiPen, indicating a statistically significant improvement [9][12] - At 2.5 minutes, 67% of NS002 subjects reached the therapeutic threshold versus 27% for EpiPen; at 5 minutes, 88% for NS002 versus 64% for EpiPen [10][12] - NS002 demonstrated 60% higher total epinephrine absorption in the critical 10-minute window compared to EpiPen [13] - **Safety Profile**: NS002 was well-tolerated with no serious adverse events reported; most adverse events were mild and self-resolving [11][13] Competitive Advantages - **Speed of Onset**: NS002's rapid absorption is crucial for emergency situations, potentially reducing the need for repeat doses [8][11] - **Device Design**: NS002 is a compact, needle-free device that is easy to carry, enhancing patient convenience and compliance [4][54] - **Shelf Life**: The dry powder formulation offers enhanced stability and longer shelf life compared to liquid formulations [54] Future Development Plans - **Pivotal Study**: Planned for initiation in Q4 2026, with top-line data expected by Q1 2027; will include comparisons to EpiPen and intramuscular adrenaline [15][39][56] - **Regulatory Strategy**: The company aims to submit an NDA in the second half of 2027, focusing on demonstrating comparability to EpiPen for FDA approval [39][48] Market Potential - **Physician Acceptance**: There is openness among allergists to switch patients to needle-free options, indicating potential market uptake for NS002 [18] - **Best-in-Class Potential**: The company believes NS002 could be a best-in-class treatment based on its pharmacokinetic profile and performance compared to existing products [23][24] Additional Considerations - **Publication Plans**: The company intends to publish study data in a peer-reviewed journal and present at major allergy conferences [30][31] - **Comparative Analysis**: While comparisons to other products like Neffy were discussed, the focus remains on NS002's superior profile based on available data [37] This summary encapsulates the critical insights and developments discussed during the conference call, highlighting the potential of Nasus Pharma's NS002 in the anaphylaxis treatment landscape.
Nasus Pharma Announces Positive Top Line Data from Phase 2 Clinical Study of NS002: Achieves Significantly Superior and Faster Epinephrine Delivery Compared to EpiPen® with Accelerated Speed to Therapeutic Threshold
Globenewswire· 2026-03-16 11:30
Core Insights - Nasus Pharma's NS002 demonstrated significantly faster absorption of epinephrine compared to EpiPen®, achieving the critical 100 pg/mL threshold in a median of 1.69 minutes versus 3.42 minutes [1][2][5] - The company plans to initiate a pivotal clinical study for NS002 in the fourth quarter of 2026 [2][4] Group 1: Clinical Study Results - The Phase 2 study enrolled 50 healthy adults, showing NS002's advantages in various administration scenarios during anaphylactic emergencies [3] - At 2.5 minutes, 67.4% of NS002 participants reached the therapeutic threshold compared to 27.1% with EpiPen® [5] - By 10 minutes, approximately 95% of NS002 participants reached the therapeutic threshold, indicating superior performance [5] Group 2: Pharmacokinetic and Pharmacodynamic Advantages - NS002 reached peak concentration in a median of 15 minutes, faster than EpiPen®'s 19.8 minutes [5] - Total epinephrine absorption in the critical 10-minute window was about 50% higher with NS002 compared to EpiPen® [5] - Repeat doses of NS002 maintained pharmacokinetic advantages, crucial for patients needing additional doses during severe anaphylaxis [5][6] Group 3: Safety Profile - NS002 exhibited a favorable safety and tolerability profile, with no serious adverse events reported [6] - The study results suggest NS002 could outperform EpiPen® in real-world conditions, including challenging scenarios [6] Group 4: Company Overview - Nasus Pharma is focused on developing innovative intranasal products, with NS002 as a needle-free alternative for anaphylaxis treatment [8] - The proprietary Nasax® powder platform is designed for rapid and reliable drug delivery, leveraging the nasal cavity's vascular network [8]
Nasus Pharma to Present Topline Analysis from NS002 Intranasal Epinephrine Powder Phase 2 Single and Repeat Dose Clinical Study
Globenewswire· 2026-03-09 12:30
Core Insights - Nasus Pharma Ltd. is set to host a conference call and webcast on March 16, 2026, to present the topline analysis from the Phase 2 repeated dose clinical study of NS002, an intranasal powder epinephrine product candidate [1] Company Overview - Nasus Pharma is a clinical-stage pharmaceutical company focused on developing innovative intranasal powder products for acute medical conditions [4] - The NS002 product is being developed as a needle-free alternative to epinephrine autoinjectors for patients experiencing anaphylaxis [4] - The company's proprietary powder-based intranasal (PBI) technology aims for rapid and reliable drug delivery, utilizing the nasal cavity's vascular network for quick absorption [4] - The PBI formulation employs uniform spherical powder particles for broad dispersion and potentially faster absorption compared to liquid-based nasal products [4] Conference Call Details - The conference call will take place at 8:00 a.m. ET on March 16, 2026, and will include a question-and-answer session following the data presentation [1] - Individuals can register for the webcast through a provided link, and dial-in numbers for the conference call are available for both US and international participants [6]
Nasus Pharma to Present and Participate in the Upcoming Life Sciences Investor Forum
Globenewswire· 2026-03-09 12:00
Core Viewpoint - Nasus Pharma Ltd. is participating in the upcoming virtual Life Sciences Investor Forum, showcasing its innovative intranasal products aimed at treating emergency medical conditions [1]. Company Overview - Nasus Pharma is a clinical-stage pharmaceutical company focused on developing intranasal powder products for acute medical conditions [3]. - The company's lead product candidate, NS002, is an intranasal powder formulation of Epinephrine, designed as a needle-free alternative to traditional autoinjectors for anaphylaxis treatment [3]. - The proprietary powder-based intranasal (PBI) technology enables rapid and reliable drug delivery, utilizing the nasal cavity's vascular network for quick absorption [3]. - The PBI formulation features uniform spherical powder particles, which may allow for broader dispersion and potentially faster absorption compared to liquid-based nasal products [3]. Presentation Details - Company management will be available for one-on-one meetings during the conference, and interested parties are encouraged to arrange meetings through their conference representative [2]. - The presentation is scheduled for March 11, 2026, at 12:30 p.m. ET, and will be led by CEO Dan Teleman [4].
Nasus Pharma (NYSEAM:NSRX) Earnings Call Presentation
2026-02-25 12:00
A NEW FRONTIER IN INTRANASAL DRUG DELIVERY A clinical-stage pharmaceutical company leveraging its proprietary powder-based intranasal technology to develop innovative intranasal products Company Presentation – February 2026 Ticker NSRX Exchange NYSE American Please migrate color palette to match website Forward Looking Statements; Disclaimer This presentation of Nasus Pharma Ltd. (the "Company", "Nasus" or "Nasus Pharma") contains "forward-looking statements" within the meaning of the Private Securities Lit ...
Nasus Pharma Announces Closing of $15.0 Million Private Placement
Globenewswire· 2026-02-13 13:00
Core Viewpoint - Nasus Pharma Ltd. has successfully closed a private placement of ordinary shares and warrants, raising approximately $15.0 million to advance its clinical development programs, particularly the NS002 intranasal epinephrine product candidate [1][3]. Group 1: Private Placement Details - The private placement involved the sale of 2,695,425 ordinary shares and accompanying warrants at a combined purchase price of $5.565 per share [3][5]. - Citizens Capital Markets acted as the lead placement agent, with Laidlaw & Company (UK) Ltd. serving as the co-placement agent [2]. Group 2: Use of Proceeds - The net proceeds from the private placement will be utilized to advance the pivotal clinical development of NS002 for anaphylaxis treatment, initiate first-in-human studies for other products, and for general corporate purposes [5]. Group 3: Product Development Focus - NS002 is being developed as a needle-free alternative to epinephrine autoinjectors, aimed at providing rapid drug delivery in emergency situations [8]. - The company is focused on leveraging its proprietary intranasal technology across various therapeutic areas to enhance clinical value [3][8]. Group 4: Financial Strengthening - The financing is expected to significantly strengthen the company's balance sheet and provide funding visibility for planned operations and development activities [3][5]. Group 5: Warrants Information - The warrants have an exercise price of $6.53 per share, are immediately exercisable, and will expire two years from issuance or 30 trading days after the announcement of NS002 pivotal study results [4].
Nasus Pharma Announces Positive Interim Results from Phase 2 Clinical Study of NS002 Intranasal Epinephrine Powder
Globenewswire· 2026-01-20 13:00
Core Insights - Nasus Pharma's NS002 shows significantly faster absorption and higher peak epinephrine levels compared to EpiPen, with 91% of participants achieving the 100 pg/ml plasma threshold at 5 minutes versus 67% for EpiPen [1][3] - The interim results indicate that NS002 is well-tolerated with no serious adverse events reported, and the pharmacodynamic response is comparable to EpiPen [1][5] - Full Phase 2 results are expected by the end of Q1 2026, with a pivotal study initiation planned for Q4 2026 [1][7] Study Design - The open-label Phase 2 study enrolled 50 healthy adults with a history of allergic rhinitis, divided into two cohorts [2] - The first cohort of 25 participants received NS002 or EpiPen with and without a nasal allergic challenge, while the second cohort received repeat doses under similar conditions [2] Key Interim Results - NS002 achieved a mean peak plasma concentration (Cmax) of 655 pg/ml compared to 548 pg/ml for EpiPen, with a peak concentration (Tmax) reached in 10.8 minutes versus 15 minutes for EpiPen [3] - Total epinephrine absorption in the critical 10-minute window was higher for NS002 (AUC: 55 h*pg/ml) compared to EpiPen (AUC: 32 h*pg/ml) [3] Safety and Tolerability - NS002 was well-tolerated, with 95% of treatment-emergent adverse events being mild and self-resolving, primarily local [5] - The pharmacodynamic response, including changes in blood pressure and pulse rate, remained within normal ranges and was comparable to EpiPen [5] Expert Commentary - Clinical experts highlight the potential of NS002 as a significant advancement in anaphylaxis treatment due to its faster delivery and higher concentrations of epinephrine [6] - The needle-free administration of NS002 could address compliance challenges associated with current treatments [6] Future Plans - Nasus Pharma aims to complete the Phase 2 study by the end of Q1 2026 and plans to initiate its pivotal clinical study in Q4 2026 [7]