Company advancing innovative, small molecule for treatment of refractory chronic cough where there are currently no FDA-approved therapies
Lead program, EX937, initially targeting a $11B global market with potential to expand into multiple high-value indications
Differentiated approach with demonstrated preclinical efficacy and safety
Rapidly advancing towards the clinic with potential value driving milestones in 2024

AURORA, CO / ACCESSWIRE / January 25, 2024 / Exxel Pharma ("Exxel" or the "Company"), an early-stage pharma company working to develop EX937 as a safe and effective treatment for patients suffering from refractory chronic cough, today provided a business overview and outlined its expected upcoming milestones.

Exxel is leveraging innovative science and research to reduce neuronal hypersensitivity and address a number of chronic conditions, including refractory chronic cough. The Company uses a differentiated approach and EX937 works by specifically inhibiting the fatty acid amide hydrolase (FAAH) enzyme, thereby increasing the levels of anandamide, a naturally occurring signaling molecule. Anandamide plays a number of roles throughout the body, including sensory and pain modulation, and increased levels are expected to desensitize overactive sensory neurons in the upper airways of chronic cough patients, limiting the urge to cough.

Soren Mogelsvang, PhD, President and Chief Executive Officer of Exxel commented, "Chronic cough is a persistent condition that has a significant negative impact on overall quality of life for adults. With no currently FDA-approved therapies available, treatment options are limited and often marginally effective, with some side-effects. Our lead program, EX937 has demonstrated profound effects in a variety of animal models of cough, neuropathic pain, hyperactive bladder and migraine headache. We are dedicated to advancing this important and much-needed therapy and believe it has the potential for broad clinical application and commercial opportunities."

The Company's lead program, EX937, is a first-in-class, proprietary small molecule being developed for refractory chronic cough, a large underserved market with no current FDA-approved therapies, that affects approximately 10% of the global population.

Key Program Highlights

• Once-a-day oral dosing
• Potential for Fast Track Designation
• Demonstrated efficacy and favorable safety by being entirely excluded from the central nervous system and brain

Expected Upcoming Milestones

Q1 2024

• Drug product prototype test results

Q3 2024

• Completion of drug product development
• Availability of drug product specification
• Launch enrollment and dose first patient in the first-in-human Phase 1/1b study

Q1 2025

• Completion of SAD study
• Report topline data from SAD

Q3 2025

• Completion of MAD study
• Completion of cough challenge cohort

Q4 2025

• Report topline data from MAD
• Report topline data from cough challenge cohort

For more information about the Company's development program, please visit exxelpharma.com and connect with the Company on LinkedIn , X and Facebook .

About Exxel Pharma

Exxel Pharma is a privately held company focused on developing novel therapeutics for the treatment of neuronal hypersensitivity disorders. The Company's lead program, EX937, is a first-in-class, proprietary small molecule being developed for refractory chronic cough, a large underserved market with no current FDA-approved therapies, that affects approximately 10% of the global population. Leveraging a differentiated approach by inhibiting the FAAH enzyme, EX937 has demonstrated efficacy and favorable safety in its ability to modulate chronic cough in preclinical models. The Company is rapidly advancing the development of EX937 towards a first-in-human Phase 1/1b study. EX937 also has the potential to be utilized across a number of blockbuster indications, including hyperactive bladder, peripheral neuropathic pain and migraine headaches. For more information, please visit exxelpharma.com .

Investor Contact:

Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 833.475.8247
E: exxel@jtcir.com

SOURCE: Exxel Pharma, Inc.