Aptevo Therapeutics Inc

Last modified by Asif Farooqui on 2022/12/15 18:08

Summary

  • Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on developing novel immunotherapies for the treatment of cancer.
  • Aptevo Therapeutics Plans a Phase 2 Trial in 2H23 in Frontline and Relapsed/Refractory Patients who are Venetoclax Treatment Naïve

APVO0.png

Aptevo Therapeutics Inc (Nasdaq: APVO) is a clinical-stage, research and development biotechnology company focused on developing novel immunotherapeutic candidates for the treatment of different forms of cancer.

Recent Developments

Aptevo Therapeutics Plans a Phase 2 Trial in 2H23

December 12, 2022; Aptevo Therapeutics Plans a Phase 2 Trial in 2H23 in Frontline and Relapsed/Refractory Patients who are Venetoclax Treatment Naïve1

Aptevo Therapeutics Inc; announced that APVO436, in combination with venetoclax and azacitidine, achieved a 100% clinical benefit rate (CBR) in venetoclax treatment naïve AML patients. The data, which was presented in a poster session at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition in New Orleans, also showed that APVO436, when given in combination with this standard-of-care regimen, was observed to be generally safe and well tolerated.

Aptevo plans to initiate a Phase 2 trial in the second half of 2023 to further evaluate APVO436 in combination with venetoclax and azacitidine among frontline and relapsed/refractory AML patients who are venetoclax treatment naïve.

In the Phase 1b trial cohort 2, a total of 16 response-evaluable patients received the combination therapy of venetoclax and azacitidine with APVO436 and 75% experienced clinical benefit. 100% of patients in this cohort who had not received venetoclax previously, experienced clinical benefit; a favorable outcome with respect to a variety of response categories including CR, CRi and MLFS.

Pipeline

ADAPTIR™ and ADAPTIR-FLEX™ Therapeutic Canididate Portfolio2

APVO1.png

Financial Highlights

Third Quarter 2022 Results

November 10, 2022; Aptevo Therapeutics Reports Third Quarter 2022 Financial Results and Business Highlights3

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 its Amendment to Royalty Purchase Agreement with HCR. As a result of the Amendment, the company 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 the company 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 the company recorded upon the initial sale of the royalties to HCR.

The Amendment does not affect the potential $22.5 million in milestone payments the company 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 its APVO436 clinical trial as the company continue to advance that trial in its 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 its Amendment to Royalty Purchase Agreement. Additionally, interest expense on its MidCap Credit Agreement has decreased due to principal payments made in 2022.

Discontinued Operations: For the three months ended September 30, 2022 and 2021, the company collected $0.2 and $0.1 million in deferred payments from Medexus related to IXINITY sales, respectively. Pursuant to its 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.

Company Overview

Aptevo is a clinical-stage, research and development biotechnology company focused on developing novel immunotherapeutic candidates for the treatment of different forms of cancer. Aptevo has developed two versatile and enabling platform technologies for rational design of precision immune modulatory drugs. The company's lead clinical candidate, APVO436, and preclinical candidates, ALG.APV-527 and APVO603, were developed using its ADAPTIR™ modular protein technology platform. The company's preclinical candidate APVO442 was developed using its ADAPTIR-FLEX™ modular protein technology platform.

The versatile and robust ADAPTIR and ADAPTIR-FLEX platforms are designed to generate monospecific, bispecific, and multi-specific antibody candidates that are capable of enhancing the human immune system against cancer cells. ADAPTIR and ADAPTIR-FLEX are both modular platforms, which gives it the flexibility to generate immunotherapeutic candidates with a variety of mechanisms of action.

APVO2.png

Technology

Aptevo is a clinical stage biotechnology company focused on development of novel immunotherapies using its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies.4

ADAPTIR-FLEX™ Technology

ADAPTIR-FLEX technology extends advantages of ADAPTIR technology to create protein therapeutics with varied specificity and valency and potentially new modes of action.

Current Pipeline Candidates using ADAPTIR-FLEX Technology:

  • APVO442 (PSMA x low affinity CD3)

ADAPTIR™ Technology

Demonstrated ability to produce monospecific and bispecific drug candidates. Leverages IgG1 Fc to form homodimeric bispecific molecules. Optimized to minimize proteolytic cleavage and post-translational modifications

Current Pipeline Candidates using ADAPTIR Technology:

  • APVO436 (CD123 x CD3): Clinical candidate for the treatment of AML, MDS
  • ALG.APV-527 (41BB x 5T4): Preclinical candidate, planned to advance into clinic for the treatment of solid tumors expressing 5T4
  • APVO603 (41BB x OX40): Preclinical candidate that actives two costimulatory receptors on immune cells for the treatment of multiple solid tumor indications

References

  1. ^ https://aptevotherapeutics.gcs-web.com/news-releases/news-release-details/100-clinical-benefit-rate-achieved-phase-1b-trial-evaluating
  2. ^ https://aptevotherapeutics.com/pipeline/
  3. ^ https://aptevotherapeutics.gcs-web.com/news-releases/news-release-details/aptevo-therapeutics-reports-third-quarter-2022-financial-results
  4. ^ https://aptevotherapeutics.com/our-technology/
Tags: US:APVO USA
Created by Asif Farooqui on 2022/12/15 17:41
     
This site is funded and maintained by Fintel.io