8/5/2021

speaker
Operator
Conference Call Operator

Good morning, and thank you for joining our conference call. Today, we will provide an update on Athenix's business.

speaker
Tim
Investor Relations

as well as a review of financial results for the second quarter of 2021. The news release detailing the results crossed the wire earlier this morning and is available on the company's website. A replay of this call will also be archived on the company's website. During the conference call, the company will make projections or forward-looking statements regarding future events, including statements about financial, business, and clinical milestones anticipated in fiscal year 2021 and beyond. We encourage you to review the company's past and future filings with the SEC, which identify specific factors that may cause the actual results or events to differ materially from those described in the forward-looking statements. You can find our SEC filings in the EDGAR database at www.sec.gov or in the Investor Relations section at our website at www.athenix.com. This morning we are joined by Dr. Johnson Lau, Chief Executive Officer, Mr. Jeff Yorden, Chief Operating Officer, Dr. Rudolph Kwan, Chief Medical Officer, Mr. Randall Zee, Chief Financial Officer, and Dr. Dan Lang, President of the Phoenix Cell Therapy. The management team will be available to answer questions after the prepared remarks. I will now turn the call over to Johnson for introductory comments. Johnson?

speaker
Dr. Johnson Lau
Chief Executive Officer

Thank you, Tim. There were several important developments and a phoenix in the second quarter that I would like to cover this morning. I want to discuss the progress we have made with the FDA on Oropacetaxel plus Enzequeda, the ongoing commercialization of this theory, as well as the recent QA therapeutics acquisition, which is part of an ongoing plan to build a presence in cell therapy. During the second quarter, We held a Type A meeting with the FDA to discuss the deficiencies that had been raised in the complete response letter we received in February. The FDA encouraged us to continue development of olpraclitaxel for the treatment of metastatic breast cancer. A key topic at the meeting was how we can potentially address the deficiencies raised in the CRL. We are now evaluating the option of conducting a new clinical study and working on the optimal design for such a study that we plan to present to the FDA later this year. We are very conscious, of course, about the capital and time requirements. Ultimately, we hope there is a path that we can agree on that is viable and that will result in better creation for our stakeholders. Dr. Rudolph Kwan, our Chief Medical Officer, will provide more details later. We continue to believe that Oropracotexel has demonstrated a very strong and compelling clinical profile, and that it offers superior efficacy and safety compared with IV Pracotexel. If approved, we intend to position it as the chemotherapy of choice in metastatic breast cancer. As we consider our strategy for the metastatic breast cancer indication, it is important to remember that we have other programs evaluating oral pachytexel in additional indications and in combination with other therapies. This includes our angiosarcoma study the combination with prembolizumab study, and the iSpy2 trial. Again, Dr. Kwan will provide more details later. Kisiri, or terpenibulin ointment, our first-in-class microtubule inhibitor for the treatment of epidemic keratosis of the face or scalp, launched in the U.S. in February, led by our partner, Amral. Amaral provided an update on the launch progress on their most recent earnings call. Their main focus at this point in the launch is on gaining payer coverage in the U.S. to drive sales volume. We are delighted to see that Kisiri continues to gain market share in the AT market, and that feedback from patients and dermatologists has been positive. Amaral highlighted the need for new therapies like ours, given that existing topical therapies are associated with significant side effects. We are also pleased to report that Amaral recently received approval from the European Commission to market the series in Europe. This is another important milestone that will bring a new and innovative treatment option to more AK patients. Amaral is preparing for the launch in Europe, expected in second half of this year. We announced in July that we have signed additional license agreements to commercialize Casiri. Siparis, a subsidiary of CSL, will market the product in Australia and New Zealand. And Avea Pharma is our partner in Canada. These new agreements are part of the game plan to develop a global presence for Kisiri and to extend access to more patients around the world. Phoenix now has strategic partnerships for terpidipaline in place in major markets, including North America, Europe, Australia, Japan, and China. In May, we acquired Cure Therapeutics. Cure has developed a potential first-in-class NKG cell therapy treatment for neuroblastoma as well as an allogeneic platform for hematologic and solid medical disease based on technology licensed from the Data College of Medicine. In the near term, the acquisition provides a Phoenix with two attractive assets with solid clinical data and potential additional data readouts over the next 12 to 18 months. Importantly, there is also an opportunity to combine allogeneic NGT cells with our TCLT cell therapy in solid tumors. Acquiring CURE is a strategically important move for iFINEX and consistent with our mission to bring innovative cancer treatments to patients. is becoming increasingly recognized in the medical and scientific communities that cell therapy holds the promise of being a game-changer in the treatment of cancer. Dr. Dan Lang, our President of Atheist Cell Therapy, will provide an update on TUA and discuss in progress makes sense we make this acquisition. There's also a management update I want to discuss. We have announced that Mr. Randall Zee, our chief financial officer, has given us notice that he will be leaving APNX. Randall has made a decision to return to the financial sector. We'll be initiating a formal search for a replacement CFO. In the meantime, Mr. Stephen Adams, our corporate controller, will take on the role of Interim Chief Accounting Officer. Steve has been with a Phoenix since 2009, and he is very familiar with all aspects of our business. His financial function is in very capable hands. Randall has been a valuable member of the team, and I want to thank him for his contributions and wish him well in his next position. Cash at the end of second quarter was $146.7 million. As stated previously, we continue to assess very carefully about how to utilize and manage our resources efficiently and conserve cash. Our current priorities are to maximize the growth potential for our orthoscopsy and cell therapy programs while supporting our APS-APD business. Coupled with prudent cash management, we continue to review our financing options opportunistically, as you will learn more from Randall in the discussion on our financials. We will evaluate all scenarios for our business and remain focused on maximizing value for our shareholders. With that, I will turn the call over to Dr. Rudolph Kwok.

Disclaimer

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