https://www.eaaci.org/eaaci-congresses/eaaci-2022

Tel Aviv Israel June 23 2021– Nasus Pharma Ltd a clinical-stage biopharmaceutical
company focused on developing needle-free, powder-based Intranasal (PBI) specialized
product portfolio, to address acute medical conditions announced positive results from
a pilot trial of intranasal powder-based Epinephrine.

FMXIN002 is an investigational intranasal epinephrine powder spray device that is
noninvasive, user-friendly and reliable and could provide timely effective rescue for
severe potentially life-threatening allergic reactions to food, medications and insect
bites. The pilot study is the first human study for powder Epinephrine and provides
additional compelling evidence to the robustness of Nasus Pharma intranasal powder
technology in addition to the recently published results of its intranasal Naloxone
pivotal study.

“The results of the study with FMXIN002 powder intranasal Epinephrine show that it can
provide a safer and more effective rescue for the emergency treatment of life-
threatening allergic reactions by providing an easy-to-use device and quicker absorption of Epinephrine”.
Said Dr. Dalia Megiddo. Nasus Pharma CEO.

The FMXIN002 pilot study was an open-label, ascending single dose, two-period, three-
treatment, comparative bioavailability study designed to compare the PK profile of
FMXIN002 with the current standard of care- an intramuscular epinephrine autoinjector.
(EpiPen® , Mylan )

Twelve (12) volunteers with known seasonal allergies received three-sequenced
treatment with either 0.3 mg IM epinephrine via an autoinjector or FMXIN002 in
dosages of 1.6 and 3.2 mg. Each intranasal dosage was tested under normal conditions
and under nasal allergen challenge in which nasal congestion was created to simulate
the congestion of the nose in anaphylaxis. All in all, five treatments were given in a cross-over design to compare the PK/PD response to epinephrine delivered by FMXIN002 or injection with and without a nasal allergen challenge.
The results demonstrate that the exposure (AUC0-t) and maximum plasma level (Cmax) of
a 3.2 mg FMXIN002 dose was comparable to a 0.3 mg IM injection of epinephrine under
normal nasal conditions. The time to maximum plasma level (tmax) and time to 100
pg/mL of a 3.2 mg FMXIM002 dose was significantly faster than IM injection. Time to
100 pg/mL was 10.2 minutes under normal conditions and 1.2 minutes under allergenic
challenge that represents the real-life conditions of the nose in severe allergic reaction
for FMXIN002 . T max for IM injection was 19.8 minutes. The time to 100 pg/mL is
considered to be the clinical threshold where pharmacodynamic responses begin to
occur.

FMXIN002 showed significantly superior PK profile especially during the first 30 minutes
in a simulation of the real-life nasal congestions that occurs in severe allergic reactions:
Cmax was double, compared to IM autoinjector (1110 vs. 551). AUC (0-8h ) was 56% higher
(672 vs. 431) and Tmax was significantly shorter (2.0 min vs. 19.8 min) .

These finding combined with the significantly shorter time to reach the therapeutic
clinical threshold of 100 pg/mL indicate that FMXIN002 can provides an unprecedented
quick rescue with a non-invasive easy to use device for life threatening allergic
reactions.

The treatment was well tolerated with no significant side effects and there were no
excess changes physiological parameters.

Dr. Dalia Megiddo, Nasus Pharma CEO, said: “In cases of severe life-threatening allergic
reaction the therapeutic time window is very short and immediate rescue with
Epinephrine is required. Therefore, the pharmacokinetics /pharmacodynamics of
epinephrine rescue are extremely important for this immediate period. Failure to
administer epinephrine promptly has been identified as the most important factor
contributing to death in patients with allergies. Parents and care givers are often reluctant to give injections. A user-friendly simple nasal inhaler could make the much- needed rescue therapy be given in time. This, in addition to the significantly shorter time to therapeutic blood levels and higher dose in the relevant first half an hour
FMXIN002 could change dramatically the risks associated with severe allergy and
anaphylaxis”.

Udi Gilboa Nasus Pharma active chairman of Nasus board added: It is well established
that powder nasal drugs enjoy better bioavailability, quicker absorption and better
stability compared to fluid nasal formulations. Nasus Pharma’s robust intranasal powder
technology is proven again to deliver significantly quicker higher doses of rescue therapy
in cases of medical emergencies where immediate therapy is needed. As with our
Naloxone program now heading towards NDA, Nasus Pharm will continue to move
forward with its development programs in collaboration with the regulatory authorities
and with its pre-commercialization efforts with all stake-holders.

Prof. David Stepensky, Department of Clinical Biochemistry and Pharmacology, Faculty
of Health Sciences, Ben-Gurion University of the Negev, Israel

Timely administration of epinephrine in cases of severe allergy and anaphylaxis is imperative in these life-threatening situations. The findings of this pilot study indicate that powder-based intranasal epinephrine can offer significant clinical advantages, as
compared to the currently-available intramuscular route of drug administration.
Powder-based products are also known to have better stability, as compared to the
solution-based products. This could offer an additional advantage for powder-based

formulation of adrenaline, a drug that undergoes rapid degradation in the currently-
available short shelf-life liquid dosage forms.

About FMXIN002

FMXIN002 is an powder formulation of epinephrine nasal spray developed by Nasus
Pharma based on its unique intranasal powder proprietary technology. The company
believes that the FMXIN002 may enable people to deliver epinephrine in emergency
situations easily, rapidly, and with less hesitation, at the onset of an allergic reaction, as
compared to currently available epinephrine auto-injectors. FMXIN002 uses APTAR
Nasal Unidose Powder device – an intuitive and easy-to-use device with 360°
functionality and precise one-dose nasal drug delivery.

Anaphylaxis is a severe, life-threatening allergic reaction with a sudden onset that can
occur within a few minutes —and unless treated promptly could be fatal. Some 5 million
people in the United States are at risk of having an anaphylaxis reaction. Over 200,000
emergency room visits due to severe reactions from food allergies are reported
annually.

About Nasus Pharma
Based on its unique microsphere technology, Nasus Pharma is developing a number of
intranasal powder products aimed at assisting patients in several acute emergency
situations such as opioid overdose and anaphylactic shock.
Intranasal administration is most suitable for those situations in which rapid drug
delivery is required and offers multiple advantages such as rapid drug delivery, ease of
use, non-invasiveness, and safety. Nasus portfolio comprises a number of programs:

Intranasal Naloxone completed pivotal study and Intranasal Epinephrine (phase 2) as
well as a number of preclinical POC programs.

Contact:
Info@nasuspharma.com
Nasus Pharma Ltd. Israel
Tel: 972547707807
https://www.nasuspharma.com

• Significantly higher rapid absorption of Naloxone – may be critical to rescue of over-dose victims.  

• Excellent safety profile. 

• NDA submission planned for later this year. 

Tel Aviv Israel April 13 2021 — Nasus Pharma Ltd a clinical-stage biopharmaceutical company focused  on developing needle-free, powder-based Intranasal ( PBI ) specialized product portfolio, to address  acute medical conditions & public health threats announced positive results from a pivotal trial of  intranasal powder based Naloxone.  

The results of this single-dose, bioequivalence study of FMXIN001001 4 mg microspheres powder and  Narcan® 4 mg/0.1 ml nasal spray showed that FMXIN001- Nasus Pharma powder-based Naloxone was  absorbed significantly faster into the blood. Most notably in the first minutes and up to one hour FMXIN001 created significantly higher blood levels of Naloxone during the critical time for life-saving  treatment of opioid overdose: 

Area Under Curve ( AUC) after nasal inhalation of FMXIN001 in the first 4 minutes was 163% compared  to solution based Narcan® ( p=0.005), 125% after 10 minutes ( p=0.047), and AUC between 10-30  minutes was 113% compared to Narcan® ( p=0.01). Cmax was 113% ( p=0.003). 42 health volunteers participated in the study. Side effects were minor and self-resolving representing  an excellent safety profile. 

The immediate time frame for treating victims of opioid overdose is extremely short and getting  Naloxone quickly into the blood stream could have a critical influence on patient’s condition and  mortality risk. The rapid rise in Naloxone levels in the blood may be advantageous for reversing  respiratory depression in opioid overdose. The superior absorption profile and the superb safety can  position FMXIN001 as the leading overdose reversing drug. 

Because Naloxone is a competitive opiate receptor antagonist, its efficacy in reversing overdose  depends on both the quantity of opioids used and their relative affinities for opiate receptors. This  information is rarely available to first responders (or bystanders) attempting to resuscitate a suspected  overdose therefore immediate and effective treatment is critical.  

Over 81,000 drug overdose deaths occurred in the United States in the 12 months ending in May 2020,  the highest number of overdose deaths ever recorded in a 12-month period, according to recent  provisional data from the Centers for Disease Control and Prevention (CDC)ⁱ. This is especially relevant  because of the dramatic rise in the abuse of high-potency opioids such as fentanyl that requires higher  concentrations of Naloxone to treat overdose. Indeed, field studies show that about a third of opioid  overdose victim will need a second dose within the first few minutes and about 16% will need a third  dose.

“The results announced today demonstrate the impressive advantages of Nasus Pharma powder based  intranasal technology combined with the tested reliability of Aptar Pharma’s Unidose Powder device,” said Dr. Dalia Megiddo , Nasus Pharma co-founder and CEO. “The advantages of intranasal  administration of Naloxone in the treatment of opioid overdose are well established, and absorption of  our powder-based Naloxone to the blood in the first few minutes could signify higher lifesaving effect  especially in patients with serious respiratory depression. We are focused on our NDA submission later  this year with an objective to commercialized FMXIN001 in 2022.”  

Udi Gilboa, Nasus Executive Chairman and Nasus Pharma co-founder said, “The current COVID  pandemic masked the ongoing pandemic of opioid overdose in the public eye, despite the fact that it  contributed to the alarmingly increased use of high potency opioids and the rising mortality from  overdose. We believe FMXIN001 with its very well differentiated IP can be a more effective way to  deal with this critical public-health threat and to better treat victims of opioids overdose non-invasively and safely. We are working toward commercial readiness during 2022 ”.  

About FMXIN001 

Nasus Pharma IP protected powder based composition for intranasal delivery is comprised of uniform  spherical API’s and a carrier approved for inhalations. The active compound’s shape, size, and  morphology in combination with a device provides rapid and precise delivery of the drug to the blood  stream. FMXIN001 is a combination drug device using Aptar Pharma’s Unidose Powder device. Each  single use device contains 4 mg of Naloxone powder. More details can be found on the Nasus  Pharma’s website.  

About Nasus Pharma 

Based on its unique microsphere technology, Nasus Pharma is developing a number of intranasal  powder products aimed at assisting patients in several acute emergency situations such as opioid  overdose and anaphylactic shock.  

Intranasal administration is most suitable for those situations in which rapid drug delivery is required  and offers multiple advantages such as rapid drug delivery, ease of use, non-invasiveness, and safety.  Nasus portfolio comprises a number of programs: Intranasal Naloxone completed pivotal study and  Intranasal Epinephrine (phase 2) as well as a number of preclinical POC programs. 

Contact:  

Info@nasuspharma.com 

Nasus Pharma Ltd. Israel  

Tel: 972547707807 

https://www.nasuspharma.com ⁱ https://emergency.cdc.gov/han/2020/han00438.asp