SUDA Pharmaceuticals Ltd (ASX:SUD) has released its preliminary financial report for the 2021 financial year, a period during which the drug delivery company secured Therapeutic Goods Administration (TGA) approval for its ZolphiMist® insomnia treatment.
Over FY21, the healthcare stock more-than-doubled its net asset value, jumping from $4.1 million to just under $9 million thanks to an increase in cash and cash equivalents.
The ASX-lister also spent the 12-month period advancing its cancer treatment portfolio, which includes the anagrelide formulation, described as a “radically new, first-in-class approach to the treatment of cancer”, and a global, exclusive licence for an iNKT cell therapy platform.
SUDA ended the financial year with $6.7 million in the bank to sustain development across its research and development portfolio.
TGA approval for ZolphiMist®
One of the key highlights from the financial year came in July 2020, when SUDA was granted TGA approval for ZolphiMist®.
The US Food and Drug Administration (FDA) approved, patented, cherry-flavoured, oro-mucosal spray formulation is used to combat insomnia and is now included in the Australian Register of Therapeutic Goods.
The key approval means the insomnia treatment can be commercialised and supplied within the Australian market and paves the way for SUDA to secure regulatory approval for its product suite, while the move will also assist the ASX-lister’s partners in the same fashion.
Australian patent for anagrelide
Another key milestone occurred in September when SUDA’s patent application for anagrelide was accepted by the Australian Patent office.
An FDA and European Medical Association (EMA) approved drug for treating blood disorders that’s being repurposed for use in cancer, anagrelide could offer a valuable adjunctive therapy for existing therapies that leverage immunotherapy.
A patent titled ‘Prevention and Treatment of Metastatic Disease in Thrombocytotic Cancer Patients’ was granted to cover the drug candidate’s new application, set for expiry in 2035.
Canine study for anagrelide oral spray
In the same month, SUDA secured the final report on a canine pharmacokinetic study into the cancer treatments use as an oral spray.
In this trial, the healthcare stock set out to determine whether a formulation of this nature would provide a safer route of drug administration for cancer patients compared to the drug’s commercial capsule form.
Promisingly, one of the oral spray formulations displayed a statistically significant increase in the drug’s bioavailability — meaning how much of its active contents can be absorbed in the patient’s bloodstream.
Because of this substantial difference, an oral spray could help provide a lower dose of anagrelide, thereby reducing a patient’s exposure to the cardiostimulatory intermediate.
MedPharm was appointed during the 12-month period to stabilise and optimise the oral spray formulation.
Two new SABs join the force
As it continues to advance the anagrelide portfolio, SUDA has added valuable experience to its scientific advisory board.
Swedish Professor of Haematology Gunnar Birgegård, an expert in platelet biology and cancer, and leading US-based cancer researcher Dr Anil K Sood are lending their expertise to the research and development program.
Exclusive licence for iNKT cell therapy
In mid-June, SUDA signed a global, exclusive licence agreement with Imperial College London for a novel invariant Natural Killer T (iNKT) cell therapy platform.
The iNKT platform is in its preclinical stages and can be used in conjunction with chimeric antigen receptors (CARs) to treat various blood cancers, with the CAR-iNKT cells expected to be suitable for off-the-shelf dosing, because as one healthy donor can supply cells to treat many patients.
SUDA CEO and managing director Dr Michael Baker said: “Cell therapies have transformed the way we think about cancer treatment.
“The iNKT cell therapy platform provides an opportunity to target several cancers using a product that we expect to have superior activity and to be more cost-effective, which should allow the therapy to reach more individuals.
“SUDA will be the only ASX-listed CAR-iNKT cell therapy company that is working on this cellular platform and we look forward to progressing the technology into clinical trials.”
Imperial College London director of industry partnerships and commercialisation, medicine, Stephanie Morris said: “Imperial College London is delighted to license this technology to SUDA Pharmaceuticals.
“We are impressed with the ability of their executive team to push and bring therapies to market expeditiously.
“At Imperial, our mission is to deliver world-class, transformative scientific research for societal impact.
“We believe SUDA has the vision to offer innovative therapies to cancer patients.”
Capital raisings and financials
Over the financial year, SUDA raised $10.5 million from investors to progress its operations.
It closed a one-for-one non-renounceable entitlement offer in July 2020 to raise $3.56 million, in addition to a $0.5 million placement to sophisticated investors.
Later that year, the ASX-lister brought in $2.76 million through another placement, which was oversubscribed. Directors participated in the raise to contribute $40,000.
Finally, in June 2021, conducted a third, heavily oversubscribed placement to raise a further $3.65 million.
In terms of revenue, the healthcare stock brought in $257,000 over the financial year, in addition to $900,000 in other income.
SUDA’s total comprehensive loss for the year amounted to slightly more than $5 million — down from the previous year’s $9.9 million result.
As it moves into the new financial year, SUDA intends to continue work across its insomnia and cancer treatment platforms, in addition to its migraine and cannabinoid research portfolios.