ImmunityBio officials are pictured at the 101st annual meeting of the South Central Section of the American Urological Association last fall. Anktiva, one of the company’s drugs that has been accepted for fast-track study by the federal Food and Drug Administration, is a treatment for muscle-invasive bladder cancer carcinoma.

Financial losses continue to pile up at ImmunityBio according to the company’s filing with the Securities and Exchange Commission on Thursday.

The companies accumulated deficit through Dec. 31, 2022, has reached $2.4 billion. Net losses attributable to ImmunityBio common stockholders were $416.6 million in 2022, $346.8 million in 2021 and $221.9 million in 2020. After cutting 38 employees at its Dunkirk plant in December, ImmunityBio now employs 725 people at all of its facilities. There was no new discussion of the Dunkirk facility in the SEC filing.

Earlier this month ImmunityBio officials said the company has executed financing to provide up to $60 million in working capital to support ongoing business operations through a securities purchase agreement for a registered direct offering with multiple institutional investors.

“We expect to continue to incur significant expenses as we seek to expand our business, including in connection with conducting research and development across multiple therapeutic areas, participating in clinical trial activities, continuing to acquire or in-license technologies, maintaining, protecting and expanding our intellectual property, seeking regulatory approvals, increasing our manufacturing capabilities and, upon successful receipt of FDA approval, commercializing our products,” the company’s SEC filing states.

ImmunityBio is working to bring its first product to market, submitting a drug called Anktiva to the federal Food and Drug Administration for approval. The Anktiva work led to a $23 million increase in spending in 2022 for research and development. Anktiva is a treatment for muscle-invasive bladder cancer carcinoma that has been granted Breakthrough Therapy and Fast track designations by the FDA and is a step toward ImmunityBio’s goal of replacing high-dose chemotherapy with immunotherapy in cancer treatment — a treatment ImmunityBio officials want to provide without the use of toxic drugs. Company officials anticipate FDA action on its application by May 23.

Anktiva works by boosting NK and T cells, which are components of the adaptive and innate immune systems. It provides a secondary boost to the immunological response induced by bladder cancer or by a checkpoint inhibitor for other indications via this mechanism.

A trial showed 71% of patients who had previously failed on other therapies demonstrated a more than 50% improvement in response and median duration compared to alternative treatments Valrubicin and Pembrolizumab.

In addition to treating bladder cancer, a study released in late December by the Wisconsin National Primate Research Center has shown Anktiva was shown to reduce the amount of simian immunodeficiency virus after four weeks of the drug’s use, resulting in a reduction of the disease present in the primates. ImmunityBio officials say the primate research could lead to Anktiva being used to treat or even cure HIV.

“We expect our research and development expenses to increase significantly for the foreseeable future as we continue to invest in research and development activities related to developing our product candidates and conduct our ongoing and planned clinical trials,” the filing states.

Discussion of the Dunkirk plant continued to focus on additional construction needed in the facility and the need for additional government support of construction activities. Through Dec. 31, 2022, ImmunityBio has received $1.1 million in construction reimbursement from New York state and expects between $8 and $10 million of government funding to be available as of Dec. 31. Despite its December layoff, the company has not changed its long-term projection of hiring 300 employees in the first 2.5 years of operation and 450 total employees within its first five years of operations.

“…there can be no assurance as to the final acceptance and timing of the requests for governmental funding that we submit, and we will need to plan and fund most of the additional build-out of, and purchase additional equipment for, the Dunkirk Facility in connection with our planned full operations,” the SEC filing states. “In addition, any future governmental funding will be subject to the eligibility of submitted expenses, as well as our compliance with the obligations that we are subject to pursuant to the agreements with parties regarding the Dunkirk Facility as described above.”