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LTR PHARMA LIMITED — Capital/Financing Update 2024
Dec 9, 2024
65273_rns_2024-12-09_de2de462-a345-4ddd-a91c-34e5f33ad82b.pdf
Capital/Financing Update
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LTR Pharma Announces Successful A$25 million Placement to Support SPONTAN[® ] through the FDA Regulatory Pathway and U.S. Commercialisation
10 December 2024
Highlights:
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LTR Pharma Limited (ASX:LTP) secures binding commitments to raise A$25 million to support SPONTAN[®] through the FDA process and commercialisation in the U.S. ED market
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Strong support from new and existing institutional investors, including international and healthcare focussed funds, validates the commercial potential of SPONTAN[®]
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Funds will be strategically allocated across key value drivers:
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U.S. commercial preparations and FDA regulatory pathway activities
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R&D investment to expand product portfolio and manufacturing scale-up
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Launch of telehealth platform
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LTR Pharma is now funded through until the end of 2026 which includes key upcoming valuecreating milestones as it advances towards commercialisation
LTR Pharma Limited ( ASX:LTP ) (“ LTR Pharma ”, “the Company ”), a company focused on improving men’s health through the clinical development and commercialisation of an innovative nasal spray treatment for Erectile Dysfunction ( “ED” ), SPONTAN[®] , is pleased to announce that it has received binding commitments for a A$25 million placement, receiving strong support from institutional and sophisticated investors, as well as key healthcare focussed funds. A total of 27,173,913 fully paid ordinary shares at an issue price of $0.92 per share will be issued as part of the capital raising.
Funds raised from the placement will be applied to accelerate the commercialisation and growth of SPONTAN[®] as set out below:
| Uses | A$M |
|---|---|
| US Commercial Preparations | 10.5 |
| Regulatory Activities & Animal Toxicity Studies | 2.0 |
| SPONTAN®Derivatives & Variations (Development) | 1.0 |
| Marketing Studies & Website Development | 4.0 |
| Working Capital | 6.0 |
| IR / Costs of the ofer | 1.5 |
| Total | 25.0 |
LTR Pharma Chairman, Lee Rodne, commented: "We are very pleased to announce our successful A$25 million placement, underscoring the strong support from institutional investors. I would like to thank our existing shareholders for their continued support and welcome our new shareholders who have joined us on this exciting journey."
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"This funding is a critical milestone for LTR Pharma as we advance towards commercialising SPONTAN[®] in the US, Australia and other key markets. With our preparations for regulatory engagement underway, and with our strategic partnerships, including our co-development agreement with Aptar Pharma, we are well-positioned to bring a first-inclass, rapid-onset treatment to market."
"This marks the beginning of the next transformative chapter for LTR Pharma as we look ahead to the commercialisation of SPONTAN[®] and pioneering innovations in nasal spray therapeutics."
Placement Details
The Placement comprises the issue of up to 27,173,913 Shares to raise A$25 million (before costs), pursuant to the Company’s placement capacity under ASX Listing Rule 7.1 and 7.1A. The A$0.92 issue price per share represents a 12.4% discount to the close of trading on Thursday, 5 December 2024. Settlement of the Placement is expected to occur on Friday, 13 December 2024. Bell Potter Securities Limited and Alpine Capital Pty Limited acted as Joint Lead Managers to the Placement.
SPONTAN[®] Development
As announced to the market in June 2024 and October 2024, SPONTAN[®] has achieved positive primary and secondary clinical study results from its pivotal pharmacokinetic trial. The trial showed rapid absorption and faster time to maximum concentration compared to oral PDE5 inhibitors at half the dose.
Following these positive outcomes, SPONTAN[®] has commenced early market access through Australia's Therapeutic Goods Administration (TGA) Special Access Scheme and Authorised Prescriber Scheme, enabling healthcare professionals to prescribe SPONTAN[®] to patients with unmet needs. The Company has also secured a strategic global Co-Development Agreement with Aptar Pharma to support the commercialisation of SPONTAN[® ] in key markets, including the United States
LTR Pharma is actively pursuing expedited regulatory pathways, including the FDA's 505(b)(2) process in the United States and Category 1 - Type F application with the TGA in Australia. The Company has further strengthened its commercial positioning through a joint venture with the Restorative Health Clinic to develop an innovative online healthcare platform, capitalising on the growing telehealth market and expanding access to men's health services.
men's health services and ED treatment, offering patients a fast-acting, on-demand solution that could transform the standard of care in this therapeutic area.
In addition, the Company is seeking to leverage its IP and invest in product R&D to expand its nasal spray product portfolio for ED and non-ED applications.
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This announcement has been approved by the Board of Directors.
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.
For further information, please contact:
Haley Chartres Media Relations [email protected]
Peter McLennan Investor Relations [email protected]
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