New Risk • Jun 11
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 42% per year over the past 5 years. Revenue is less than US$1m (AU$1.1m revenue, or US$793k). Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Market cap is less than US$100m (AU$77.3m market cap, or US$54.1m). Reported Earnings • Mar 03
First half 2026 earnings released: AU$0.032 loss per share (vs AU$0.016 loss in 1H 2025) First half 2026 results: AU$0.032 loss per share (further deteriorated from AU$0.016 loss in 1H 2025). Net loss: AU$5.76m (loss widened 140% from 1H 2025). New Risk • Feb 28
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 42% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Revenue is less than US$5m (AU$1.6m revenue, or US$1.2m). Market cap is less than US$100m (AU$81.8m market cap, or US$58.2m). Announcement • Sep 23
LTR Pharma Limited, Annual General Meeting, Oct 24, 2025 LTR Pharma Limited, Annual General Meeting, Oct 24, 2025. Location: at the offices of k&l gates, 16/66 eagle street, qld 4000., brisbane Australia Reported Earnings • Aug 31
Full year 2025 earnings released: AU$3.34 loss per share (vs AU$0.05 loss in FY 2024) Full year 2025 results: AU$3.34 loss per share. Net loss: AU$5.59m (loss narrowed 20% from FY 2024). Announcement • Aug 18
LTR Pharma Limited Appoints Andrew Y. Sun to Its Scientific Advisory Board LTR Pharma Limited announced the appointment of Dr Andrew Y. Sun, M.D., a fellowship-trained urologist and nationally recognized expert in male sexual and reproductive medicine, to its Scientific Advisory Board. Based in Texas, Dr Sun brings extensive experience in prescribing PDE5 treatment protocols and will advise on integrating LTR's intranasal therapies ROXUS® and SPONTAN® into treatment pathways for erectile dysfunction, particularly for patients experiencing side effects with existing oral medications. Dr Sun is Director of Men's Health at Urology Partners of North Texas, one of the state's largest men's health clinics. He trained at Harvard Medical School, completed a residency at the Cleveland Clinic Glickman Urological and Kidney Institute, and undertook fellowship training in Male Reproductive Medicine and Surgery at UCLA. His clinical experience spans erectile dysfunction, ejaculatory dysfunction, male infertility, hormone management, and Peyronie's disease. Dr Sun is an active contributor to US national clinical guidelines and a frequent speaker at leading urology conferences. He is an active member of the American Urological Association, the American Society for Reproductive Medicine, and the International Society for Sexual Medicine. Dr Sun contributes to clinical guidelines for the Sexual Medicine Society of North America and leads national training programs in erectile restoration with Boston Scientific. As a thought leader in men's sexual health, Dr Sun is a frequent presenter at international scientific meetings and has authored multiple peer-reviewed journal articles. His expertise is widely recognized through regular appearances on prominent podcasts, including BackTable Urology, Bionic Health, and Urology Times' "Pearls & Perspectives", where he shares insights on testosterone therapy, men's health program development, and sexual dysfunction management. He has been interviewed at major conferences, including the American Urological Association annual meeting, reflecting his influential position within the urology community. Announcement • Apr 01
LTR Pharma Limited Announces Change of Company Secretary, Effective 1 April 2025 LTR Pharma Limited advised that in accordance with ASX Listing Rule 3.16.1, that Mr. David Hwang and Ms. Elizabeth Spooner of Confidant Partners have been appointed as Joint Company Secretaries, effective immediately.
For the purposes of ASX Listing Rule 12.6, Mr. David Hwang and Ms. Elizabeth Spooner will be the persons responsible for communications with ASX in relation to Listing Rule matters. Ms. Shelby Coleman will step down
as Company Secretary, effective immediately. New Risk • Mar 31
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 58% per year over the past 5 years. Revenue is less than US$1m (AU$500k revenue, or US$312k). Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (30% increase in shares outstanding). Market cap is less than US$100m (AU$83.2m market cap, or US$52.0m). New Risk • Jan 23
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (AU$49k revenue, or US$31k). Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (30% increase in shares outstanding). Market cap is less than US$100m (AU$155.6m market cap, or US$97.5m). Announcement • Dec 11
LTR Pharma Limited has completed a Follow-on Equity Offering in the amount of AUD 25 million. LTR Pharma Limited has completed a Follow-on Equity Offering in the amount of AUD 25 million.
Security Name: Ordianry Shares
Security Type: Common Stock
Securities Offered: 27,173,913
Price\Range: AUD 0.92
Discount Per Security: AUD 0.0552
Transaction Features: Subsequent Direct Listing New Risk • Dec 10
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: AU$150.7m (US$96.4m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (AU$49k revenue, or US$31k). Minor Risk Market cap is less than US$100m (AU$150.7m market cap, or US$96.4m). Board Change • Oct 03
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. No highly experienced directors. Independent Non-Executive Director Maja McGuire was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Jul 26
LTR Pharma Limited has completed a Follow-on Equity Offering in the amount of AUD 10.5 million. LTR Pharma Limited has completed a Follow-on Equity Offering in the amount of AUD 10.5 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 14,383,562
Price\Range: AUD 0.73
Discount Per Security: AUD 0.0438
Transaction Features: Subsequent Direct Listing New Risk • May 22
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk No financial data reported. Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Market cap is less than US$100m (AU$69.7m market cap, or US$46.5m). Announcement • Dec 18
LTR Pharma Limited Receives Approval from the Bellberry Human Research Ethics Committee for Bioequivalence Clinical Trial LTR Pharma Limited shared positive results from a clinical trial in a presentation at The 24th World Meeting on Sexual Medicine (WMSM) in Dubai on 16 December 2023. Associate Professor Eric Chung, a certified Fellow of the Royal Australasian College of Surgeons (RACS) and the Urological Society of Australia and New Zealand (USANZ), presented the data to a meeting of his peers in sexual health. The core objective of the study was to assess the bioavailability of SPONTAN (SDS-089 nasal Vardenafil solution) in human plasma levels (using liquid chromatography tandem mass spectrometry analysis). The study showed that SPONTAN delivered a high plasma concentration level of Vardenafil drug, based on pharmacokinetic LC/MS data analysis with robust accuracy and precision. LTR Pharma is planning to expedite its FDA 505(b)(2) regulatory process for SPONTAN. The Company has received approval from the Bellberry Human Research Ethics Committee ("HREC") for a bioequivalence clinical trial comparing SPONTAN with the FDA approved ED drug Levitra. The trial will compare the pharmacokinetics, safety, and tolerability of Vardenafil following administration of SPONTAN and Levitra® tablets in healthy male adults. Patient recruitment is expected early next year, with trial sites to open in Sydney, Australia in First Quarter CY24. Introduction: The nasal drug delivery system offers many advantages when compared with oral administration, such as a faster onset of action, easily accessible, less drug degradation, and a high rate of absorption. The SDS-089 nasal Vardenafil (VDF) solution is a unique drug formulation designed to be delivered as a spray formulation. Objective: To assess the bioavailability of SDS-089 nasal Vardenafil solution in human plasma levels using Liquid Chromatography Tandem Mass Spectrometry analysis. Methods: The SDS-089 Vardenafil HCl formulation was prepared with the active pharmaceutical ingredient to the United States Pharmacopeia (USP) standard (batch 1704002361). The SDS-089 nasal spray solution was filtered (0.22 m filter) and fitted with a nasal spray device to deliver 100 L per spray which is equivalent to 2 mg Vardenafil HCl alcoholic solution per spray. This study received approval from the Institutional Review Board and Biosafety Committee (FB18/IRB/099). Blood samples from participants were collected at time 0 (pre-dose) and across different time intervals up to 10 hours and analyzed using Liquid Chromatography Tandem Mass Spectrometry (LC/MS) to quantify the level of Vardenafil and the internal standard. This protocol allows for the preparation and analysis of human samples, quality controls (QC), standard curve preparation, and instrumental analysis. During the validation experiments, each calibration standard and QC sample was prepared by spiking a specified amount of Vardenafil in human plasma with oral Vardenafil drug served as the internal standard for comparison. The concentration of analytes in each standard was quantified using LC/MS and detected using multiple reaction monitoring for each of the respective analytes. The lower limit of quantitation (LLOQ) was defined as the lowest concentration that could be quantified with accuracy and precision within 20%, as calculated from chromatograms for the independent samples. Intra- and inter-run accuracy and precision were calculated for the three QC samples, and independent triplicate measurements with best-fit lines were selectedusing a linear regression model with a 1/x2 weighting factor in the calibration curves. Results: The SDS-089 nasal Vardenafil solution showed excellent accuracy (mean 100, Standard Deviation, SD 4.1, % Relative Standard Deviation, RSD of 4%) and good precision (mean 50.1, SD 2.1, %RSD of 4%) on high (50ng/ml) QC assay tests. Similarly, the stability of QC on high (50ng/ml) plasma assay tests showed excellent accuracy (mean 100.8, SD 3.7, %RSD of 4%) and good precision (mean 50.4, SD 1.8, %RSD of 4%) on high (50ng/ml). Comparison between pharmacokinetic parameters of Vardenafil SDS-089 nasal spray (4mg) and oral tablet (10mg) showed T1/2 (2.52±0.99 vs 2.46±0.73 hour), Tmax (0.17±0.54 vs 0.97±0.35 hour), Cmax (time concentrations) (9.21±4.11 vs 11.24±7.83 ng/mL) and AUC0-inf (area under the curve from zero to infinity) (21.03±12.54 vs 37.25±41.51 ng/mL*h) . Conclusions: SDS-089 nasal formulation appeared to deliver a high plasma concentration level of Vardenafil drug based on pharmacokinetic LC/MS data analysis with robust accuracy and precision.