Trading cash for single-digit royalties on products, the deal provides ImmunityBio with the cash it’ll need to potentially commercialize its bladder cancer drug, if approved. The PDUFA date is April 23, 2024.
Pictured: Artist rendering of bladder cancer concept/iStock, wildpixel
ImmunityBio has struck a royalty deal with Oberland Capital, potentially adding $320 million to its coffers. The biotech is shoring up its cash reserves, while banking on FDA approval this spring for its bladder cancer drug.
Tuesday’s deal brings in $210 million now, with another $100 million on the line contingent on the approval of N-803—to be marketed as Anktiva—combined with Bacillus Calmette-Guérin (BCG) for certain types of bladder cancer. Under the agreement, Oberland will receive single-digit royalty payments on net sales of the company’s products. The equity investment includes $10 million funded at closing and a five-year option to purchase up to an additional $10 million
“This transaction raises significant capital for the company to support important growth plans, yet with limited equity dilution and with a cap on total payments tied to the initial investment,” ImmunityBio CEO Richard Adcock said in a statement.
ImmunityBio took a hit in May 2023 when the FDA rejected its BLA for the drug. At the time, the issues seemed to center around deficiencies with the company’s third-party manufacturer. The FDA has since accepted ImmunityBio’s resubmission and set a new PDUFA date of April 23, 2024, setting the company back close to a year from its anticipated timeline.
An additional $470 million equity and debt financing from its founder—Patrick Soon-Shiong—in September 2023 also helped bolster ImmunityBio’s balance sheet, helping it to hold on for the anticipated FDA approval.
Anktiva is a first-in-class IL-15 superagonist. Combined with BCG treatment, data from its Phase II/III trial showed a complete response in 58 out of 82 patients with BCG-unresponsive high grade non-muscle invasive bladder cancer (NMIBC). For all patients in the trial, the probability of avoiding surgery to remove part or all of the bladder was 84% with disease-specific survival at 100%.
The treatment is also being investigated in NMIBC patients who are BCG-naive and BCG-unresponsive NMIBC papillary patients.
Cash from the Oberland deal will be spent commercializing the Anktiva combo for bladder cancer, as well as trials to expand the drug into solid tumor indications. The company may need to replenish its headcount after laying off 48 employees in September 2023 following the FDA’s Complete Response Letter as well as 30 staffers in October 2022 due to “economic reasons.”
Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.
