SUDA Pharmaceuticals Ltd Advances Insomnia and Cancer Treatment Profiles in FY21


The drug distribution company raised $ 10.5 million to advance its operations during the year as it secured key regulatory and patent approvals for its business and research portfolios.

() has published its preliminary financial report for fiscal year 2021, during which time the drug distribution company obtained approval from the Therapeutic Goods Administration (TGA) for its ZolphiMist® insomnia treatment.

In FY21, Healthcare more than doubled its net asset value 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 portfolio of cancer treatments, which includes the formulation of anagrelide, described as a “radically new and first-class approach to the treatment of cancer”, and an exclusive worldwide license for an iNKT cell therapy platform.

SUDA ended the year with $ 6.7 million in the bank to support the development of its research and development portfolio.

TGA Approval for ZolphiMist®

One of the highlights of the year came in July 2020, when SUDA obtained TGA approval for ZolphiMist®.

The US Food and Drug Administration (FDA) approved, cherry flavored, mouth-mucous spray formulation is used to combat insomnia and is now listed in the Australian Therapeutics Registry.

The key approval means that the treatment for insomnia can be commercialized and supplied to the Australian market and paves the way for SUDA to gain regulatory approval for its product line, while this move will also help the partners of the ASX-lister in the same way.

Australian patent for anagrelide

Another key milestone occurred in September when SUDA’s patent application for anagrelide was granted by the Australian Patent Office.

A drug approved by the FDA and the European Medical Association (EMA) for the treatment of blood disorders that is reused for use in cancer, anagrelide could offer valuable adjunct therapy for existing therapies that take advantage of the immunotherapy.

A patent entitled “Prevention and treatment of metastatic disease in patients with thrombocytotic cancer” has been granted to cover the new application of the drug candidate, which is expected to expire in 2035.

Canine study for oral anagrelide spray

That same month, SUDA obtained the final report of a canine pharmacokinetic study on the use of cancer treatments as an oral spray.

In this trial, the healthcare inventory investigated whether a formulation of this nature would provide a safer drug delivery route for cancer patients compared to the commercial capsule form of the drug.

Promisingly, one of the oral spray formulations showed a statistically significant increase in the bioavailability of the drug, that is, the amount of its active content that can be absorbed into the bloodstream of the patient.

Because of this substantial difference, an oral spray could help deliver a lower dose of anagrelide, thereby reducing a patient’s exposure to the intermediate cardiostimulator.

MedPharm was appointed during the 12 month period to stabilize and optimize the formulation of the oral spray.

Two new SABs join the force

As it continues to advance the Anagrelides portfolio, SUDA has added valuable experience to its Scientific Advisory Board.

Swedish professor of hematology Gunnar Birgegård, an expert in platelet and cancer biology, and leading US cancer researcher, Dr Anil K Sood, are contributing their expertise to the research and development program.

Exclusive license for iNKT cell therapy

In mid-June, SUDA signed an exclusive global license agreement with Imperial College London for a new 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 cancers of the blood, with CAR-iNKT cells believed to be suitable for a standard assay, because as a donor healthy can provide 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 offers the ability to target multiple cancers with a product that we believe will be more potent and cost effective, which should allow the therapy to reach more people.

“SUDA will be the only ASX-listed CAR-iNKT cell therapy company working on this cellular platform and we look forward to advancing the technology into clinical trials.”

Stephanie Morris, Director of Industry Partnerships and Marketing, Medicine at Imperial College London, said: “Imperial College London is delighted to license this technology to SUDA Pharmaceuticals.

“We are impressed with the ability of their management team to rapidly push and bring therapies to market.

“At Imperial, our mission is to provide transformative, world-class scientific research for societal impact.

“We believe SUDA has the vision to deliver innovative therapies to cancer patients.”

Capital raising and finance

During the year, SUDA raised $ 10.5 million from investors to advance its operations.

He closed a non-waivable one-for-one rights offering in July 2020 to raise $ 3.56 million, in addition to a $ 0.5 million placement with sophisticated investors.

Later that year, the ASX-lister brought in $ 2.76 million from another placement, which was oversubscribed. The directors participated in the fundraising to contribute $ 40,000.

Finally, in June 2021, made a third highly oversubscribed placement to raise an additional $ 3.65 million.

In terms of sales, the health care stock brought in $ 257,000 for the year, plus $ 900,000 in other income.

SUDA’s aggregate aggregate loss for the year was just over $ 5 million, down from a year earlier of $ 9.9 million.

As the new fiscal year approaches, SUDA intends to continue working on its insomnia and cancer treatment platforms, in addition to its migraine and cannabinoid research portfolios.

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