PLL Therapeutics presents strategic approach for early detection and treatment of Amyotrophic Lateral Sclerosis (ALS) at Bioshares Biotech Summit

Talk will highlight for investors role of PLL Therapeutics’ poly-L-Lysine-based therapy in helping combat neurodegenerative disorders and in early-stage and companion biomarkers.

Villenave-d’Ornon (near Bordeaux), France, August 6, 2025 – PLL Therapeutics, a biopharmaceutical company developing a groundbreaking polypeptide delivery platform to treat the root cause of autoimmune and neurodegenerative diseases, today announces it will present its strategic approach in the early detection and treatment of Amyotrophic Lateral Sclerosis (ALS), a form of motor neuron disease, at the 19^th Bioshares Biotech Summit. Bioshares is Australia’s leading biotech stock report. The summit, hosting the leading emerging life science companies listed on the ASX, with 35 companies presenting over a two-day period, is taking place this week at the Hotel Grand Chancellor in Hobart, Tasmania, August 7 – 8.

PLL Therapeutics is currently conducting a Phase I/II multi-stage study on ALS in Australia. Following recent safety validation of its first patient cohort, involving 12 ALS patients who underwent the testing of three different doses of PLL Therapeutics’ drug therapy PLL001, given by subcutaneous injection, alongside a placebo; the study will now progress, without any restrictions, to a Phase II trial. This will consist of 140 patients and enrollment is expected to start in September.

At the Bioshares session on: ‘What the Heck Biotech!’, which explores novel approaches in therapeutics, Jean-Pascal Zambaux, co-founder and CEO of PLL Therapeutics, will deliver a presentation titled: ‘A New Paradigm in ALS – treating the root cause of the disease’.

Mr. Zambaux will share insights on the mechanism-of-action underpinning the company’s polypeptide delivery platform that uses poly-L-Lysine, a universal carrier, to target organs and inflammation, and restores the integrity of the gut lining (leaky gut) as well as the blood-brain-barrier, without side effects. Investors will discover how PLL Therapeutics tackles the pro-inflammatory molecules that enter the blood stream as a result of excessive gut permeability, which can damage neuron cells and form protein aggregates. The critical need for a definitive method to diagnose ALS and the potential of PLL Therapeutics’ early-stage blood biomarker test will be underscored.

« PLL Therapeutics is proud of our groundbreaking work in ALS research, driven by our commitment to patient care and excellent clinical trials network in Australia, where we have fostered regional ties and strengthened collaborations,” said Mr. Zambaux. “We are excited by the prospect of attracting investor interest through the Bioshares Biotech Summit, offering them a unique opportunity to deepen their understanding of our polytargeted therapeutic approach. This is an investment in the future of ALS patients, aiming to improve their quality of life and extend the typical lifespan beyond the current three to five years after symptoms appear.”

Within the Phase I/II study, PLL Therapeutics is also investigating the early-stage detection and tracking of ALS. It is conducting large-scale blood sampling to evaluate the efficiency of its diagnostics kit to measure the biomarkers linked with excessive gut permeability and how those biomarkers evolve with treatment.

“Our diagnostics kit is the first-of-its-kind to use serum antibodies to measure the onset of ALS, offering the potential to become the standard reference in detecting and tracking many neurodegenerative diseases,” added Mr. Zambaux.

Presentation:

Title: ‘A New Paradigm in ALS – treating the root cause of the disease’

Date/time: Thursday, August 7, at 5:40 to 6:00pm (GMT+9)

Location: Hotel Grand Chancellor, Hobart, Tasmania

About PLL001

Lead candidate, PLL001, is a poly-targeted therapy consisting of several APIs (Active Pharmaceutical Ingredients) that, when combined, are able to restore the microbiome and stop the gut from leaking toxins into the bloodstream. The underlying premise is that the origin of ALS and other auto-immune or neurodegenerative diseases lies in the intestine.

Dysbiosis in the gut microbiota, leading to increased gut permeability to the bloodstream, represents 90% of the origin of neurodegenerative diseases, such as ALS, in association with genetic links. PLL001 is derived from PLL Therapeutics’ patented Poly-L-Lysine drug transport system, which successfully delivers four Small Chain Fatty Acids (SCFAs) – known to be effective against ALS’ neuro-inflammatory and neurodegenerative pathways – to the epithelium gut cells and the Blood-Brain Barrier (BBB). It releases the drug at the ‘point of use’.

About PLL Therapeutics

PLL Therapeutics, a biopharmaceutical company developing a groundbreaking polypeptide delivery platform, is spearheading a unique early-stage diagnostics and therapeutic approach for treating the root cause of autoimmune and neurodegenerative diseases. PLL Therapeutics focuses on restoring gut integrity. Its initial indication is Amyotrophic Lateral Sclerosis (ALS), a fatal motor neuron disease. The company’s lead candidate is PLL001, a ‘poly-targeted’ drug therapy aimed at destroying the initialization of the disease. PLL Therapeutics’ approach will play a key role in the early detection of autoimmune and neurodegenerative diseases (ALS) and proliferative disorders (colon cancer) through specific biomarkers.

Founded in 2019, PLL Therapeutics is led by a highly experienced management team. A Phase I/II clinical trial is underway. The company is located near Bordeaux, France.