A $920 million share offering completed last week has given Abivax enough financial runway to bring its bowel disease drug to the American market independently, without relying on a partnership with a major pharmaceutical company, CEO Marc de Garidel said Friday.
"Thanks to the cash we raised… We are in a position to have cash until the end of 2029, and … build up the right infrastructure to launch in the U.S.," de Garidel told CNBC's "Squawk Box Europe."
The $920 million in gross proceeds — yielding roughly $874 million after underwriting commissions and expenses — came after underwriters exercised their full over-allotment option on 960,000 additional American depositary shares, bringing the total offering to 7,360,000 ADSs priced at $125 each, the company said. Abivax intends to use the net proceeds to fund potential U.S. commercialization of its lead drug candidate, obefazimod, along with continued clinical research for ulcerative colitis and Crohn's disease.
When asked whether Abivax would consider a takeover offer at this stage, de Garidel pushed back. "The best defense for us is actually the offense," he said.
Abivax plans to meet with the U.S. Food and Drug Administration at the end of July for a pre-NDA meeting to discuss its New Drug Application for obefazimod, de Garidel said. The company is a clinical-stage biotech listed on both Euronext Paris and Nasdaq $NDAQ under the ticker ABVX.
The raise follows a rocky period in which cancer diagnoses flagged during a late-stage ulcerative colitis trial rattled investors and raised doubts among analysts about the drug's commercial prospects, driving a sharp selloff in the company's shares. Abivax stock fell as much as 40% after an earlier readout from its 44-week Phase 3 maintenance trial identified seven cancer diagnoses across the study population — none of which investigators linked to the drug — unsettling investors and prompting a downgrade from Jefferies analyst Faisal Khurshid.
About four weeks later, Abivax stock climbed more than 30% after the company released supplemental data showing the cancer cases were consistent with background rates expected for the patient population. Extended dosing at 50 mg produced clinical remission in 37.2% of patients whose disease had not responded to the initial induction phase, and a dose escalation from 25 mg to 50 mg brought clinical remission recovery in 45.5% of patients who relapsed during the maintenance window. Supplemental data from the same study subsequently showed the rate of malignancies fell within what would be expected for that patient population, and the stock clawed back much of its earlier decline.
Speaking Friday, de Garidel pointed to the drug's performance in patients who are difficult to treat and reiterated Abivax's view that obefazimod poses no safety concerns. "When you have ulcerative colitis, unfortunately, your immune system is depleted, and you are more susceptible to a certain type of cancer," he said. Abivax is also testing obefazimod as a treatment for Crohn's disease.