The entrance to the Athenex plant in Dunkirk is pictured. P-J file photo

Athenex is running out of cash and been dealt a major setback by the federal government.

So, what does the future hold for a company that could employ hundreds at its sparkling new Dunkirk facility?

Company officials are still holding out hope for a rebound propelled by its other offerings.

The company reported a loss of $36.1 million in its third quarter with revenues of $32.3 million and full-year product sales are expected to decline between 6% and 12% year-over-year. As of September 30, 2021, Athenex had cash and cash equivalents of $73.6 million, restricted cash of $16.5 million and short-term investments of $14.9 million for a total of $105 million. That has led to Athenex officials looking for ways to extend their cash runway beyond the fourth quarter of 2022 while trying at the same time to open its Dunkirk manufacturing facility that could help the company bring in more revenue. The company started cutting costs earlier this year after federal approvals delayed bringing oral paclitaxel, one of Athenex’s key new products, to market.

But, Jeff Yordon, Athenex chief operating officer, said revenue from product sales from the third quarter in 2021 increased 9% compared to 2020 numbers and have increased 26% sequentially from the second quarter of 2021, a sign that there is a market for Athenex products.

Weathering the storm of 2020-21 could pay off for the company next year, Yordon told investor analysts.

Athenex’s has captured the most market share for its liquid cyclophosphamide product while planning three product launches in teh third quarter and seven new products for 2022.

“We anticipate that most of these challenges will be much less severe in 2022,” Yordon said. “For the new products we have recently launched, we’ve been able to achieve meaningful market share in a short period of time. … Two of the planned new product introductions in 2022 are very significant products, and these will be launched at market formation in April and May of next year. The revenues on these two products will enable us to increase revenues and margins. Both of these products have tentative approvals and are scheduled to launch at patent exploration. We also have continued sales improvements in a few key APD products.”

Also key is opening the Dunkirk plant. Jeff Yordon, Athenex chief operating officer, told investor analysts during a recent conference call that the Dunkirk plant is expected to play a key role in the Athenex Pharmaceutical Division, which markets 33 products, and Athenex Pharma Solution, which markets five products. Construction on the facility is complete, with operation initially scheduled to begin in 2021. That has been pushed back into 2022 because of delays in state licensing. The Dunkirk plant will allow Athenex to fulfill more orders and increase its sales and revenues.

“Therefore, it’s likely going to be well into 2022 before we can fully take advantage of this new capacity,” Yordon said. “The revenues at EPS remain robust, and we are selling essentially every unit we can manufacture at attractive margins.”

Taking a longer view, Dr. Rudolf Kwan, Athenex chief medical officer, said the company is working to capitalize on its investments in oral paclitaxel by talking with Food and Drug Administration officials about registering oral paclitaxel as an angiosarcoma treatment. Phase 1 dose-finding results are promising, Kwan said, while use of oral paclitaxel in foreign countries is also being pursued.

Cell therapy is also a a key focus of research for Athenex, according to Dan Lang, president of Athenex Cell Therapy. A new product used thus far in four patients with non-Hodgkin’s lymphoma and one patient with with relapsed acute B-lymphoblastic leukemia resulted in partial response in two patients, one who showed complete remission.

“Longer term, we are excited about the opportunities for inserting TCRs onto the NKT cells to generate an allogeneic cell therapy approach for solid tumors,” Lang said. “As many of you know, solid tumors represent 90% of the oncology markets, and there remains significant unmet medical need. We believe having an allogeneic approach that allows for cost-effective repeat dosing will be an important element of success to target solid tumors. We look forward to continuing to innovate and maximize the value of NKT cell platform.”