On February 9, 2022 Aptevo Therapeutics Inc. ("Aptevo" or the "Company") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported that the Company has earned a $10 million non-dilutive milestone payment related to 2021 sales of RUXIENCE (Press release, Aptevo Therapeutics, FEB 9, 2022, View Source [SID1234607917]). Additionally, based on RUXIENCE 2021 fourth quarter and full-year sales results, the Company is optimistic about the possibility of earning additional non-dilutive milestones totaling $22.5 million over the next two years. The Company also announced that its Phase 1b trial evaluating lead drug candidate APVO436 for the treatment of acute myeloid leukemia (AML) continues to enroll new clinical trial sites and that the first complete remission patient, announced in 2021, is proceeding to transplant.
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RUXIENCE Milestones
Aptevo has earned a $10 million milestone payment related to sales of RUXIENCE under the terms of its royalty purchase agreement with HealthCare Royalty Management, LLC (HCR). The milestone will be used to pay down MidCap Financial debt, reducing outstanding principal on the debt to $5 million and strengthening the Company’s balance sheet. This, in combination with $46.3 million of cash-on-hand as of December 31, 2021, gives the Company cash runway through 1Q23, positioning Aptevo well to complete dosing in its ongoing APVO436 Phase 1b clinical trial and, in partnership with Alligator BioScience, to initiate a clinical trial for ALG.APV-527.
RUXIENCE, a Pfizer drug, is a biosimilar to RITUXAN. Pfizer reported 2021 revenue of $491 million from RUXIENCE, including $148 million in 4Q21, exceeding the $395 million threshold required for Aptevo to fully earn the 2021 $10 million milestone. Annualizing the $148 million Q4 revenue suggests 2022 full-year revenue could be approximately $592 million. Aptevo will earn $12.5 million of additional milestones in 2022 if revenue is at least $525 million. Similarly, an additional $10 million milestone can be earned in 2023 if revenue is at least $570 million. Given the above, Aptevo is optimistic about fully earning these additional future non-dilutive milestones totaling $22.5 million.
APVO436 Clinical Trial
The Company’s multi-site, multi-cohort Phase 1b clinical trial evaluating APVO436 for the treatment of acute myeloid leukemia (AML) continues to progress:
MD Anderson Cancer Center joins numerous other sites already enrolling and Aptevo plans to add additional sites this year
A patient with complete remission, announced in November 2021, is progressing to transplant
Initial data is expected mid-year 2022
"We are very pleased to announce meaningful progress in our clinical work and to reinforce the strength of our financial position, especially during such a challenging time in the market. From our inception, Aptevo has remained committed to a focused business strategy designed to deliver results that will ultimately benefit patients," said Marvin White, CEO. "On the clinical side, we are pleased to expand the number of trial sites as this increases the pool of patients potentially eligible to participate in the study. Further, we are happy to report that the patient we reported on in November, who achieved complete remission in the expansion trial, remains in remission and is proceeding to transplant. We wish them well."
"Adding to Marvin’s comments about a previously reported complete remission patient, it’s encouraging that they are proceeding to transplant after receiving a combination of chemotherapy plus APVO436. Complete remission and transplant in patients who have failed prior frontline therapy such as this one, are indicators that the patient is making positive clinical progress in fighting this difficult-to-treat disease." said Dirk Huebner, MD, Senior Medical Advisor.