Quarterly wrap: Incannex and Neurotech focus on advancing clinical trials

It’s a wrap for the September quarter. Here are some of the latest highlights from a few ASX small and midcaps on their activities for the three months to the end of September.

Incannex Healthcare (ASX:IHL)

During the quarter the US Food and Drug Administration (FDA) granted IHL IND approval to commence the IHL-42X Phase 2/3 clinical trial for patients with obstructive sleep apnoea.

Since the FDA provided clearance for the IND opening study to begin, startup has progressed rapidly. The trial, which has been given the name RePOSA, derived from Revealing the Efficacy of IHL-42X use in Patients with OSA, will assess the safety and efficacy of IHL-42X compared to the component active pharmaceutical ingredients, dronabinol and acetazolamide as well as placebo.

Screening for the IHL-42X bioavailability/bioequivalence (BA/BE) study commenced on September 8 and dosing of trial participants commenced on October 6.

IHL’s has also progressed the opening of its psychedelic-assisted psychotherapy clinics. IHL’s first Clarion Clinic in Melbourne has been designed and fitted out with the company hopeful of having all regulatory approvals in place to commence treatment in November.

IHL commenced preparations for an investigational new drug (IND) application with the FDA during the quarter for its psilocybin-assisted psychotherapy development program known as Psi-GAD. It also received HREC approval for its Phase 2 clinical trial assessing IHL-675A for use in treatment of pain and function in rheumatoid arthritis.

IHL earlier this week announced as of October 18, 99.64% of shareholder voting shares and 99.93% of option holders voting options are in favour of scheme resolutions to redomicile to the US and trade exclusively on the NASDAQ.

IHL finished the quarter with a cash balance of $25.3 million and is trading at 6.3 cents/share with a market cap of $91.65 million.

Neurotech (ASX:NTI)

September was also a busy trial quarter for NTI. During the quarter NTI concluded its last patient last visit (LPLV) at the Children’s Hospital at Westmead in Sydney for its Phase 1/2 trial of NTI164 into the treatment of orphan disorder PANDAS/PANS.

NTI recently announced the trial had reached its primary endpoints with significant and clinically meaningful improvements.

In July NTI announced Human Research Ethics Committee (HREC) approval and Clinical Trial Notification (CTN) scheme clearance by the Therapeutics Goods Administration (TGA) to start its Phase 1/2 clinical trial investigating the use of NIT164 in female Rett syndrome patients. The first patient was enrolled in the study in August and in September patient recruitment was finalised.

The company also continued to recruit patients for its Phase2/3 clinical trial into autism spectrum disorder with the company on track to finalise recruitment during Q2 FY24.

During the quarter NTI recorded total cash operating expenses of $2.4 million, consisting of R&D of $1.9 million. Total operating outflows were $2.1 million, up 91% on Q4 FY23, reflecting an significant increase in R&D.

The company closed the quarter with cash and cash equivalents of $2.9 million and expects a $3.2 million R&D tax incentive rebate to be paid during Q2 FY24, resulting in a pro-forma cash balance of $6.1 million. The company says this will be sufficient to fund its operations throughout FY24 and complete all clinical trials.

NTI is trading at 5.6 cents/share with a market cap of $52.3 million.

Parkway Corporate (ASX:PWN)

Industrial water treatment technology company PWN says it made significant progress during the quarter in leveraging its proprietary platform to support a range of strategic business development initiatives.

The company says it’s engaged with a range of existing and prospective clients requiring industrial process expertise, particularly in processing complex and concentrated brines.

PWN Parkway Process Technologies (PPT) division actively advanced a major project, subject of a recent feasibility study.

The company says PPT progressed in leveraging its proprietary process technology platform to support business development initiatives across a range of industrial applications, including mining.

During the quarter Parkway Process Solutions (PPS) achieved ongoing new business from a diverse range of clients for industrial water treatment related products, services and solutions. It continued to focus on strategically important particularly process technology focused projects with less focus on non-strategic short-term revenue generation.

PWN reported strong quarterly sales with $1.29 million generated during the quarter with quarterly cash receipts increasing to a record $1.56 million.

The company undertook a $4 million placement, underpinning its investment in tech, plant and equipment.

PWN finished the quarter with $4.91 million in cash reserves. It is trading at 1.1 cents/share with a market cap of ~$33 million.

EZZ Life Science (ASX:EZZ)

Genomic life science company EZZ reported ~$6.7 million in Q1 FY24 in cash inflows from customers, representing a 12% increase from Q1 FY23.

With a heavy presence in China EZZ says the September quarter is traditionally a slower period in mainland China’s retail sector.

Notwithstanding the typical seasonal fluctuations anticipated for the quarter, EZZ achieved cash flow of $400k from its operational activities, up 133% from the previous year.

The Company continued to expand its distribution channels and commenced trading on Onion Global’s O’Mall in July 2023.

It generated $200k of revenue in its first quarter of operations. Similar to Tmall Global and Douyin, O’Mall is one of the major cross-border e-commerce platforms in China, with ~300 million users.

In September EZZ was nominated as a finalist in the Growth Company Awards for the Health & Life Sciences Growth Company of the Year Award along with a finalist for the NSW Premier’s Export Awards in the e-commerce category.

During the quarter EZZ also formally launched its two-year partnership with HIC at an event in Guangzhou along with releasing four new products.

EZZ finished the quarter debt-free with a cash balance of $13.9 million. It is trading at 61 cents with a market cap of ~$26 million.