Four Pharma and Biotech stocks on the move in June

Actinogen Medical Limited (ASX: ACW)

The Phase 2a biomarker trial was a stand-alone, prospective, double-blind trial using plasma biomarker data and clinical data on file from participants in the XanADu Phase 2a trial. The XanADu trial treated 185 patients with mild Alzheimer’s Disease for 12 weeks. Patients received either 10mg of Xanamem or placebo. While the drug was considered safe and the data showed Xanamem inhibiting cortisol production, the results did not demonstrate statistical significance on any of the endpoints.

Of the 72 patient samples, 34 patients had elevated pTau. These patients had much more rapid progression of the disease than patients with lower levels of pTau across a number of clinical endpoints. The results of the biomarker study confirm that the XanADu trial population contained a high proportion of non-progressive patients, many of whom may have had an alternative diagnosis to Alzheimer’s Disease.

The Company is also trialling the use of Xanamem to improve the cognitive function of patients with major depressive disorder (MDD). The Company completed the final patient visit for the Phase 2a XanaCIDD trial in July and expects the results to be available in August 2024. The trial included 167 patients with persistent MDD and measurable cognitive impairment at baseline. Patients took either 10mg of Xanamem or placebo in addition to the existing anti-depressant therapy or for patients with history of anti-depressant treatment was used as a stand-alone treatment. The primary endpoint is the computerized Cogstate attention composite test battery, measuring attention and working memory. The key secondary endpoint is the Montgomery-Asberg Depression Rating Scale (MADRS) which is a structured interview evaluating MDD symptoms and is a commonly used endpoint for trials and regulatory approvals for anti-depressant medication. The results of this trial will be a catalyst for the share price in the near-term. 

Optiscan Imaging Limited (ASX: OIL)

InVue expands Optiscan Imaging’s product portfolio into the surgical application market with the device able to be used in a variety of clinical settings, most notably in cancer diagnosis and treatment. The device is designed to provide real-time digital pathology to surgeons as they operate for decision making and treatment adjustments in the operating theatre, as opposed to having to wait for the pathology work to be conducted within dedicated pathology labs.

In May 2024, the Company signed an agreement with the Mayo Clinic to develop a new endomicroscopic imaging system. The organisations will work together to co-develop technology for use in robotic surgery with an initial focus on robotic-assisted breast cancer surgery. The agreement covers a 24-month co-development plan. The robotic-assisted surgery market is experiencing significant growth and is expected to continue expanding driven by technological advancements, increasing adoption, rising prevalence of chronic diseases, an aging population, surgeon demand, and favourable reimbursement policies. The US robotic surgery service market was valued at US$1.8 billion in 2022 and is estimated to grow to US$6.4 billion in 2030.

While there are some issues to be ironed out, the Company has made significant strides in achieving its strategic goals with large addressable markets providing significant future earnings potential for the Company. 

EZZ Life Science Holdings Limited (ASX: EZZ)

EZZ formulates, produces, markets and distributes health supplements under the EZZ brand and is an exclusive distributor of skin care products under the EAORON brand in Australia and New Zealand.

On 31 May 2024, the Company announced it had signed a five-year sales agreement with Pinehills (Hong Kong) Limited. Pinehills has committed to purchasing EZZ-branded products with a minimum value of $12 million in the first 12-months. Annual purchases will increase by a minimum of 10% annually over the period of the agreement. This represents a total minimum purchase of $91.58 million over the term of the agreement. The agreement provides EZZ with expanded distribution channels into the key markets of China and Vietnam.

Race Oncology Ltd (ASX: RAC)

In June, the FDA extended the Orphan Drug Designation (ODD) to Race’s re-formulated RC220 for the treatment of Acute Myeloid Leukemia. ODD provides a wide range of benefits including 7-year US marketing exclusivity for approved orphan products, 25% federal tax credit for expenses incurred from clinical research conducted within the US with tax credits able to be applied against up to 20 years of future sales, fee waivers, research grants and regulatory assistance from the FDA.

Race is advancing RC220 to address the needs of patients for better treatments across multiple oncology indications, with a clinical focus on anthracycline combinations with the aim of protecting patient’s hearts from the permanent damage caused by chemotherapy while providing enhanced anticancer activity in a range of solid tumours.

The Bonus Options expired in June. 84% of all Bonus Options were exercised resulting in the issue of 6.7 million new shares at $0.75 per share, raising over $5 million. As part of the offer, a further three Piggyback Options for every one Bonus Option exercised were issued. Piggyback Options have an exercise price of $1.25 per option and can be exercised on or before 29 May 2026. The option exercise provided a boost to the $16.2 million the Company had in cash as at 31 March 2024.