×

ImmunityBio Trying To Find Solid Ground

Losses Pile Up

ImmunityBio’s latest Securities and Exchange Commission filings show a company still working to establish profitable operations while shining a light on the company’s purchase of a Dunkirk manufacturing facility from Athenex.

The early May filing with the SEC shows ImmunityBio losing $102,998,000 in the first three months of 2022 compared with a loss of $80,481,000 over the same time period in 2021. The company has lost $2.1 billion since it was founded, with losses coming from the costs of ongoing clinical trials and operations and research and development programs.

Company officials say they will need additional financing to pay for operations and complete development and commercialization of its various potential products. ImmunityBio is $609 million in debt while holding cash, cash equivalents and marketable securities totaling $193.2 million through March 31, 2022.

“From inception through the date of this Quarterly Report on Form 10-Q, we have generated minimal revenue from non-exclusive license agreements related to our cell lines, the sale of our bioreactors and related consumables and grant programs,” ImmunityBio officials wrote in the SEC filing. “We have no clinical products approved for commercial sale and have not generated any revenue from therapeutic and vaccine product candidates that are under development. We have incurred net losses in each year since our inception and, as of March 31, 2022, we had an accumulated deficit of $2.1 billion. Our net losses attributable to ImmunityBio common stockholders were $102.8 million and $79.6 million for the three months ended March 31, 2022, and 2021, respectively.”

The company currently has eight first-in-human treatments being studied in 27 clinical trials — 18 of which are in Phase 2 or Phase 3 development. Those studies include treatments for liquid and solid tumors, includng bladder, pancreatic and lung cancers.

“These are among the most frequent and lethal cancer types for which there are high failure rates for existing standards of care or, in some cases, no available effective treatment,” company officials said in the SEC filing. “In infectious disease,our pipeline currently targets such pathogens as the novel strain of the coronavirus (SARS-CoV-2) and humanimmunodeficiency virus (HIV).”

ImmunityBio completed acquisition of the former Athenex manufacturing plant on Feb. 14, 2022, paying $40 million in cash to Athenex and an additional $500,000 in what are termed as transaction costs. Immunity Bio is technically the tenant in the facility and is paying rent to the Fort Schuyler Management Corporation, a non-profit corporation based out of the SUNY Polytechnic Institute in Albany.

ImmunityBio is leasing the facility for $2 a year for an initial 10-year lease with an option to renew the lease with largely similar terms for another 10 years.

The transaction included ImmunityBio’s assumption of Athenex’s third-party agreements. ImmunityBio plans to spend $1.52 billion on operational expenses at the Dunkirk plant in the first 10 years of the lease and an additional $1.5 billion if the lease is extended. The initial 10-year lease ends Sept. 30, 2031.

“We also committed to hiring 450 employees at the Dunkirk facility within the first five years of operations, with 300 such employees to be hired within the first 2.5 years of operation,” ImmunityBio stated in the SEC filing. “We are eligible for certain sales tax exemption savings during the development of the Dunkirk facility, and certain property tax savings over the next 20 years, subject to certain terms and conditions, including performance of certain of the obligations described above.”

Unlike some companies, ImmunityBio hasn’t seen an adverse impact to its business from COVID-19, though company officials did note the pandemic may create problems for ongoing and planned clinical trials needed to bring its products to market. An economic downturn could also make it more difficult for ImmunityBio to begin making money.

“If the financial markets and/or the overall economy are impacted for an extended period, our results may be adversely affected,” the filing states. “In addition, we anticipate that enrollment of patients in certain studies will likely take longer than previously forecasted and that our clinical trials may require additional time to complete which would in turn impact the timeline of BLA submissions of our product candidates and subsequent revenue generation. These factors have been accounted for in the company’s anticipated upcoming milestones. During any such delays in our clinical trials, we will continue to incur fixed costs such as selling, general and administrative expenses and operating expenses related to our laboratory, GMP manufacturing, and office facilities.”

Newsletter

Today's breaking news and more in your inbox

I'm interested in (please check all that apply)
Are you a paying subscriber to the newspaper? *
   

COMMENTS

Starting at $4.62/week.

Subscribe Today