4 Pharma & Biotech Stocks on the move in April

Markets were more subdued in April after the strong start to the year. The S&P/ASX 200 Accumulation Index was down 2.9% and the S&P/ASX Small Ordinaries Accumulation Index was down 3.1%. The Healthcare sector was not immune with the S&P/ASX 300 Healthcare Accumulation Index down 2.3% in April. Despite the subdued markets there was a few companies in the Pharma & Biotech sector that experienced strong share price moves. Below we take a look at four companies whose share prices rallied during the month. 

1) Mesoblast Limited (ASX: MSB)

Mesoblast was the best performer in the coverage universe in April, with the share price rising a further 78.4% after surging 88.1% in March.

Remestemcel-L is being developed for the treatment for inflammatory diseases in children and adults including the treatment of acute graft versus host disease (aGVHD). aGVHD is a complication of an allogenic bone marrow transplant (BMT) that can potentially be life threatening. According to the Center for International Blood and Marrow Transplant Research, there are approximately 30,000 allogeneic BMTs globally per year for diseases including hematological cancers, with 25% of all cases in the pediatric population. Nearly 50% of all allogeneic BMT patients develop aGVHD. Liver or gastrointestinal involvement occur in up to 40% of all patients with aGVHD and are associated with the greatest risk of death, with mortality rates of up to 85%. There is limited treatment availability meaning there is an unmet need for a treatment for this designation.

Remestemcel-L is being developed for the treatment for inflammatory diseases in children and adults including the treatment of acute graft versus host disease (aGVHD). aGVHD is a complication of an allogenic bone marrow transplant (BMT) that can potentially be life threatening. According to the Center for International Blood and Marrow Transplant Research, there are approximately 30,000 allogeneic BMTs globally per year for diseases including hematological cancers, with 25% of all cases in the pediatric population. Nearly 50% of all allogeneic BMT patients develop aGVHD. Liver or gastrointestinal involvement occur in up to 40% of all patients with aGVHD and are associated with the greatest risk of death, with mortality rates of up to 85%. There is limited treatment availability meaning there is an unmet need for a treatment for this designation.

2) EZZ Life Science Holdings Limited (ASX: EZZ)

During the month, EZZ completed a private placement raising $854,100 with a strategic investor, Kingstone Capital Pty Ltd. The funds raised will be used to enhance distribution channels, targeting expansion into new markets including Korea, Japan and Southeast Asia. Shares in the placement were issued at $0.50, a discount to the share price prior to the announcement. The dilutive offering did not have a negative impact on the share price with the share price finishing the month at $0.89.

The company expects revenue growth to continue with total sales from the three main marketplaces expected to be up more than 75% in 3Q’FY24 compared to the pcp and new products launched in this financial year are expected to contribute to revenue growth. Further to organic growth, the company is on the lookout for acquisition opportunities. With no debt and $12.1 million cash as at 31 December 2024, the company is well placed to take advantage of opportunities as they arise.  

3) Recce Pharmaceuticals Ltd (ASX: RCE)

Recce Pharmaceuticals is a clinical-stage biotech company developing a new class of Synthetic Anti-Infectives to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens. The main product candidate, RECCE327 (R327) is the worlds only synthetic polymer sepsis drug candidate in development.

The company is seeking to submit an investigational new drug (IND) application with the FDA in 2H’CY24 for the use of R327 to treat Urinary Tract Infections (UTIs). Completion of the Phase 1 clinical trial provided valuable data on the safety and tolerability of R327 that will be used as part of the IND application.

In February the company announced it had signed an MOU with Indonesian biomedical company PT Etna Biotechnologies. The agreement is designed to facilitate late-stage clinical trials in Indonesia. More than 10% of Indonesia’s adult population (19.5 million) have diabetes, a disease that can lead to higher probabilities of foot infections, urinary tract infections, and surgical site infections. A recent study showed that 15% of sepsis patients in Indonesian hospitals had suffered from Diabetes. 

4) PYC Therapeutics Limited (ASX: PYC)

PYC Therapeutics is progressing 3 first-in-class drug candidates with the company seeking to provide clinical proof of concept for all candidates within 18 months.

During the month, the company announced the drug candidate for the treatment of Polycystic Kidney Disease (PKD) is progressing to human clinical trials after completion of the preclinical trials. GLP studies will commence in 3Q’CY24 with a regulatory submission expected to be made in 4Q’CY24 and human trials to commence in early 2025, subject to GLP studies and regulatory engagement. The company believes the product may be able to receive approval from the Phase 2 clinical trials depending on the data readouts. 

During the March quarter, the company completed dosing in the third cohort of patients enrolled in the ongoing Single Ascending Dosing (SAD) study for Rentinitis Pigmentosa type 11 (RP11), a blinding eye disease in children. In April, the company announced the Safety Review Committee determined all 3 doses to be safe and tolerable opening up a pathway for the company to initiate a Multiple Ascending Dosing (MAD) study in 2Q’CY24 and continue escalating dosing in the SAD study to identify the dose at which RP11 patients derive maximum benefit from the drug candidate. Successful results from the trial are expected to lead to the initiation of a registrational trial in 2025 aimed at supporting a NDA in 2027, subject to endpoints being met.