On November 10, 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 financial results and business highlights for the quarter ended September 30, 2022 (Press release, Aptevo Therapeutics, NOV 10, 2022, View Source [SID1234623761]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Business Highlights
Presenting new Phase 1b expansion trial data for APVO436 in the treatment of Acute Myeloid Leukemia (AML) at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held December 10-13 in New Orleans, Louisiana
The poster, entitled "Updated Results from a Phase 1 Study of APVO436, a Novel Bispecific Anti-CD123 x Anti-CD3 ADAPTIR Molecule, in Relapsed/Refractory Acute Myeloid Leukemia and Myelodysplastic Syndrome" will be presented on Sunday, December 11, 2022 from 6:00 PM-8:00 PM Central time
Announced that the US Food and Drug Administration (FDA) issued a "may proceed" notification for the ALG.APV-527 investigational new drug application (IND), allowing the initiation of clinical trials evaluating the compound for the treatment of 5T4-expressing tumors in multiple solid tumor types
Continued dosing patients in the Company’s Phase 1b expansion program evaluating APVO436 for the treatment of acute myeloid leukemia in both combination therapy and monotherapy
"We are very excited to present our APVO436 expansion phase data at the upcoming ASH (Free ASH Whitepaper) meeting, fulfilling a promise we made earlier in the year and further underscoring our enthusiasm for the compound and rationale for its continued advancement in the clinic. We are also working to rapidly progress ALG.APV-527 in the clinic for evaluation in the treatment of solid tumors. Advancing our work across these programs will put us in a strong position to produce meaningful data readouts across our clinical programs in 2023," said Marvin White, President and CEO of Aptevo. Mr. White added "The combination of our existing cash and future expected milestone payments provides us sufficient runway to conduct our business for at least the next twelve months."
Third Quarter 2022 Financial Results Summary
Cash Position: Aptevo had cash, cash equivalents and restricted cash of $22.6 million as of September 30, 2022. This includes $0.4 million of restricted cash that was released in October 2022.
Royalty Revenue: For the three months ended September 30, 2022 and September 30, 2021, royalty revenue was $0 and $3.1 million, respectively. Royalty revenue for the period covered by this report reflects revenue recorded only in the first quarter of 2022 due to our Amendment to Royalty Purchase Agreement with HCR. As a result of the Amendment, we ceased reporting as royalty revenue royalties paid by Pfizer to HCR related to Pfizer’s sales of RUXIENCE (rituximab-pvvr). The last quarter for which we reported this royalty revenue was Q1 2022. The Amendment was effected to address a Nasdaq compliance matter and had the additional effect of eliminating the requirement to report all future Pfizer non-cash royalty revenue and extinguishing the liability that we recorded upon the initial sale of the royalties to HCR.
The Amendment does not affect the potential $22.5 million in milestone payments we may collect in the future based on achievement of RUXIENCE sales thresholds in 2022 and 2023 (up to $12.5 million related to 2022 sales and $10 million related to 2023 sales). RUXIENCE is a registered trademark of Pfizer.
Research and Development Expenses: For the three months ended September 30, 2022, research and development expenses increased by $0.1 million, to $4.5 million from $4.4 million for September 30, 2021. The increase is primarily due to higher spending on our APVO436 clinical trial as we continue to advance that trial in our Phase 1b expansion program.
General and Administrative Expenses: For the three months ended September 30, 2022, general and administrative expenses decreased by $0.2 million, to $3.3 million from $3.5 million for September 30, 2021. The decrease is primarily due to lower employee and consulting costs.
Other Income (Expense), Net: Other income (expense), net consists primarily of gain on extinguishment of liabilities, costs related to debt extinguishment, accrued exit fees on debt, non-cash interest on financing agreements, and interest on debt. Other expense, net was $0.3 million for the three months ended September 30, 2022, as compared to $2.3 million other expense, net for the three months ended September 30, 2021. The decrease is primarily due to no non-cash interest expense recorded during the period due to our Amendment to Royalty Purchase Agreement. Additionally, interest expense on our MidCap Credit Agreement has decreased due to principal payments made in 2022.
Discontinued Operations: For the three months ended September 30, 2022 and 2021, we collected $0.2 and $0.1 million in deferred payments from Medexus related to IXINITY sales, respectively. Pursuant to our LLC Purchase Agreement, the rate for deferred payments increased from 2% to 5% of net sales as of June 30, 2022.
Net Income (Loss): Aptevo’s net loss for the three months ended September 30, 2022, was $7.6 million or $1.50 per share, as compared to a net loss of $6.9 million or $1.43 per share for the corresponding period in 2021.