LTR Pharma (ASX:LTP) Reports 2024 Financial Year with Significant Milestones Achieved for Erectile Dysfunction Treatment SPONTAN®

Jane Morgan Management

Sydney, Australia – 30 August 2024 | LTR Pharma Limited (ASX: LTP) ("LTR Pharma" or "the Company") is pleased to announce its results for the full financial year ended 30 June 2024 (FY24). The year showed significant progress for LTR Pharma, highlighted by successful clinical developments, key partnerships, and a strong financial position as the Company advances towards the commercialisation of its lead product to treat Erectile Dysfunction (ED), SPONTAN®.

Highlights:

• Successful Clinical Study: LTR Pharma completed the recruitment and dosing for its pharmacokinetic clinical study of SPONTAN®, a nasal spray for ED. The study demonstrated that SPONTAN® achieved a more rapid absorption and a faster onset of effects compared to oral PDE5 inhibitors. Time-to-peak concentration (Tmax) was achieved in as little as 9 minutes.

• Manufacturing Milestones: The Company completed essential steps for manufacturing validation for SPONTAN®, including stability testing, quality control checks, product purity assessments, and packaging integrity evaluations. Such steps are crucial for meeting U.S. Food and Drug Administration (FDA) requirements, as well as underscore the Company’s commitment to quality and compliance.

• Strong Financial Position: LTR Pharma completed its Initial Public Offering (IPO) in December 2023, where it raised AU$7 million. As of 30 June 2024, the Company held a cash balance of $3.10 million, and further strengthened by a subsequent $10.5 million placement which was conducted in July 2024.

• Global Partnerships and Market Expansion: LTR Pharma secured a global Co-Development Agreement with Aptar Pharma, a leader in drug delivery systems like those required for nasal delivery via a spray. SPONTAN® has also been successfully prescribed under the Therapeutic Goods Administration (TGA) early access schemes, which further highlights its market potential.

Lee Rodne, Chairman of LTR Pharma, stated: "The 2024 financial year has been transformative for LTR Pharma, marked by our successful IPO, ASX listing, and significant advancements in our SPONTAN clinical program. The positive interim results from our pivotal clinical study underscore SPONTAN's potential to address the unmet need for a fast-acting, ondemand ED treatment. We thank our development partners, investors and the medical community for their ongoing support throughout the past year. With your support, we are well-positioned to continue our momentum and remain resolutely focused on bringing this innovative therapy to market.”

Haley Chartres
Media Relations
haley@hck.digital

Peter McLennan
Investor Relations
investors@ltrpharma.com

About LTR Pharma:

LTR Pharma is focused on improving men’s health, physically and mentally, through the commercialisation of an innovative nasal spray treatment for Erectile Dysfunction. ED is a pressing health issue for millions of men that can negatively impact self-esteem and relationships, across multiple age brackets. LTR Pharma’s lead product SPONTAN® is set apart from existing ED therapies by its mechanism of action – intranasal delivery technology of a PDE5 inhibitor. The nasal cavity is a highly vascular part of the body supporting even and rapid absorption of the drug, empowering it to work within 10 minutes or less. LTR Pharma is proudly aiming to restore greater control over the timing, spontaneity, and enjoyment of sexual experiences.

Jane Morgan
Jane Morgan Management
Investor & Media Relations
jm@janemorganmanagement.com.au