What happened
Shares of ImmunityBio (NASDAQ: IBRX) were up 10% at 11:40 a.m. ET on Wednesday. The clinical-stage biotech company focuses on cell therapies and immunotherapy platforms, including vaccines and therapies to treat infections and cancers. The stock is down than 35% so far this year.
So what
The company posted two research papers on Wednesday that may have helped drive the stock up. In the first, it reported that the company has developed a self-amplifying RNA (saRNA) vaccine for COVID-19 that, unlike mRNA vaccines, is stable at room temperature. That's important because other COVID-19 cold-chain requirements have hampered vaccine distribution, particularly in less wealthy countries. The paper says the saRNA/NLC vaccine, in preclinical studies, was able to induce a strong immunity. The therapy is currently in phase 1 trials.
The other paper showed that in a phase 2 trial of a treatment for acute myeloid leukemia patients, transplanted natural killer cells showed a strong response.
Now what
ImmunityBio's stock had been down since the Food and Drug Administration (FDA) issued a complete response letter (CRL) in May for its lead therapy, bladder cancer candidate Anktiva (N-803). It's important to note that ImmunityBio may easily be able to solve the objections raised in the CRL, as they were based on what the FDA said were deficiencies in a prelicense inspection of ImmunityBio's third-party contract manufacturer, not anything to do with the drug's safety or efficacy.
ImmunityBio has strong long-term prospects because it has a pipeline that includes 13 programs, including six in phase 2 or phase 3 trials. Anktiva is in all of them, though, as it is being tested as a monotherapy and combination therapy to treat lung cancer, pancreatic cancer, Lynch syndrome, glioblastoma (a type of brain and spinal cord cancer), HIV, solid tumors, and human papillomavirus (HPV), as well as COVID-19 and bladder cancer.
The company reported an earnings per share (EPS) loss of $0.27 in the first quarter, compared to an EPS loss of $0.26 in the same period last year. It also said it had $88.8 million in cash, enough to fund operations through the first quarter of 2024. Since then, the company has raised additional cash through stock sales.
