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  • Professor Stefan Witte, Delft University of Technology

Ayala Pharmaceuticals Inc. (OTC:ADXS) Announces Continuation of RINGSIDE Phase 2/3 Study in Desmoid Tumors

--News Direct--

Clinical-stage oncology firm Ayala Pharmaceuticals Inc (OTC:ADXS) is a company that has been making significant strides in its industry and has caught the attention of many investors in recent times. The company is involved in the development and commercialization of small molecule therapeutics for patients who may be suffering from aggressive variants of cancer or rare tumors.

Additionally, the company is also working on the development of Lm-based antigen delivery products for people who may be suffering from the common variants of cancer. One of the lead candidates being developed by Ayala at this point is AL 102 which is meant for desmoid tumors and another one is ADXS 504, an LM-based early-stage prostate cancer therapy. In this context, it is perhaps necessary to keep in mind that AL 102 had also been awarded the coveted fast-track designation by the United States Food and Drug Administration, and at this point, it is in Phase 3 of a vital study.

Last week on March 3 the company was in the news after it made a key new announcement with regards to its product AL 102. The company announced that the Independent Data Monitoring Committee (IDMC) for its Phase 2/3 RINGSIDE study into the investigational new drug had completed a prespecified review of the data produced by the study.

After studying the data, the IDMC concluded that the study could continue without any modifications. It was a significant development for the company and one that must have come as a major boost for investors who may have been following the news. Ken Berlin, the Chief Executive Officer and President of the company spoke about the development as well. He thanked the IDMC for its work and recommendation about the matter.

However, more importantly, he went on to add that the product AL 102 had the potential to be the best product in its class and everyone at the company was excited about the prospect of it in helping with desmoid tumors. Berlin noted that if the product was approved by the regulators then it could prove to be a major new addition to an indication that was largely underserved.

The company had been in focus last month when it announced its financial results for the fiscal year ending on October 31, 2022, back on February 10, 2023. The company announced that at the end of the fiscal year, it had cash and cash equivalents to the tune of $25.2 million.

The revenues generated by the company for the 2022 fiscal year stood at $250,000 and that reflected a large drop from the revenues of $3.2 million in the previous year. The expenses related to research and development came in at $7.6 million but in the previous year that had been $10.6 million. The general and administrative expenses for the fiscal year actually dropped year on year to $8.9 million from $11.5 million in 2021. The net losses for the fiscal year actually dropped to $14.4 million from $17.9 million in 2021.

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