Transforms Aptevo into a ‘Pure Play' Biotechnology Company Focused on the Development of Proprietary ADAPTIR™ Bispecific Antibody Therapeutics
Strengthens Aptevo's Financial Position; Eliminates MidCap Debt Obligation; Provides Immediate Non-Dilutive Capital Extending Aptevo's Current Cash Runway
Recent Advances in Bispecific Programs Show Compelling Proof-of-Concept Clinical Data; Bispecifics Offer Key Advantages Over Other Cellular Therapies
Aptevo's Lead Bispecific Candidate APVO436 Recently Selected for Inclusion in Groundbreaking Beat AML® Master Clinical Trial
SEATTLE, WA / ACCESSWIRE / February 28, 2020 / Aptevo Therapeutics Inc. (NASDAQ:APVO), a biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR™ bispecific technology platform, announced today that it has completed the sale of its marketed recombinant factor IX therapeutic, IXINITY® [Coagulation Factor IX (Recombinant)] to Medexus Pharmaceuticals (MDP:CA) for estimated proceeds in excess of $100 million, including potential milestone and deferred payments.
Under the terms of the sale, Medexus acquired the worldwide commercial rights to IXINITY, previously marketed by Aptevo in the United States for use in people 12 years of age or older with hemophilia B. Total proceeds, estimated to exceed $100 million, include an upfront payment of $30 million as well as potential milestone payments totaling up to $11 million related to certain regulatory and commercial achievements. In addition, for up to fifteen years, Aptevo will receive deferred payments on future U.S. and Canadian net sales of IXINITY. These deferred payments are estimated to exceed $60 million based on the most recent Aptevo forecast and will vary based on actual results.
"Our divestiture of IXINITY represents a transformative event for Aptevo," said Marvin L. White, President and Chief Executive Officer. "Firstly, the significant non-dilutive funding provided by this transaction immediately strengthens Aptevo's financial position. Our cash runway will support our organization into the fourth quarter, through potential upcoming valuation catalysts in 2020. We are today repaying our $20 million debt obligation to MidCap Financial, and, as a result will also eliminate the restriction on $5 million of our cash balance. Secondly, and most importantly, this divestiture transforms Aptevo into a ‘pure play' biotechnology company sharpening our focus on our promising core technology - our ADAPTIR bispecific platform, a proprietary approach focused on developing novel antibody-based immunotherapies which hold significant promise for the treatment of cancer and other diseases. Going forward, as we execute on a ‘pure-play' biotech strategy we will continue to prioritize non-dilutive funding opportunities for future capital requirements for the organization."
Recent advances showcased by leading pharmaceutical companies at the latest American Society of Hematology annual meeting demonstrate that bispecific antibody therapies are quickly becoming established as the next wave of promising cancer immunotherapies. Compelling proof-of-concept clinical data were presented that support the potential for bispecific therapies to offer an efficacious but simpler alternative to other T cell-based immunotherapy approaches for cancer treatment.
Aptevo believes that its differentiated ADAPTIR bispecific technology platform has the potential to offer a more convenient and cost-effective solution compared to other immunotherapies such as CAR-T therapies. While these therapies have proven effective in generating robust and durable treatment responses, they remain challenging and expensive to manufacture and administer to patients. In contrast, Aptevo believes that bispecific technologies represent a simpler, more competitive ‘off-the-shelf' solution in the rapidly advancing field of cancer immunotherapy.
"As bispecifics continue to make tremendous strides forward, we are very enthusiastic about the potential of our ADAPTIR platform and our individual bispecific candidates," said Mr. White. "Importantly, our lead candidate, APVO436, which we are investigating for the treatment of acute myeloid leukemia (AML) is poised to make significant progress this year as we are now dosing at levels which the pharmacokinetic data suggest could be biologically active, and so this is a very exciting year for the ADAPTIR program. Also, recently the Leukemia & Lymphoma Society selected APVO436 for inclusion in their national Beat AML® Master Clinical Trial, giving us exposure and recognition among leading national cancer research centers and clinicians."
"We are also excited about the potential for our 4-1BB x 5T4 bispecific antibody candidate, ALG.APV-527, partnered with Alligator Bioscience, which we are focused on partnering for advancement into Phase 1 clinical development. Also, in late 2019 we introduced our newest investigational ADAPTIR candidate, APVO603, featuring a novel mechanism of action designed to amplify the adaptive immune response to cancer and which could have utility in the treatment of a variety of solid tumors. We are very excited about each of these molecules and the potential for our ADAPTIR technology to generate multiple novel bispecific compounds with unique mechanisms of action to engage and augment the immune response."
"With a stronger balance sheet and potential future milestone and deferred payments from IXINITY; a promising and productive technology engine - our ADAPTIR platform, and a streamlined focus, Aptevo is well-positioned to advance its core assets towards value-creating milestones and opportunities as we look forward to realizing the full potential of this robust platform," concluded Mr. White.
Piper Sandler acted as exclusive financial advisor to Aptevo for this transaction. Cooley acted as legal advisor to Aptevo for this transaction.
About Hemophilia B
Hemophilia B is a congenital bleeding disorder caused by a deficiency of coagulation factor IX. It affects approximately 1:25,000 male births, with approximately 4,000 persons affected in the U.S. The clinical spectrum may include spontaneous or trauma-induced bleeding into joints, muscles, and soft tissues, resulting in joint damage, reduction in mobility, and severe arthritis, all of which negatively impact health-related quality of life. The primary aim of care is to prevent and treat bleeding by replacing the deficient clotting factor.
IXINITY is indicated for the control and prevention of bleeding episodes and for perioperative management for adults and children ≥12 years of age with hemophilia B. IXINITY is not indicated for induction of immune tolerance in patients with hemophilia B. IXINITY contains recombinant coagulation factor IX (trenonacog alfa). Trenonacog alfa is a purified single chain glycoprotein derived from Chinese hamster ovary (CHO) cells and has an amino acid sequence that is comparable to the Thr148 allelic form of plasma-derived factor IX. No human or animal proteins are added during any stage of manufacturing or formulation of IXINITY. The recombinant factor IX is purified by a chromatography purification process. The process includes three validated steps for virus inactivation and removal. The process also includes a validated manufacturing step to reduce the presence of CHO proteins in the final drug product.
Indications and Important Risk Information
IXINITY [Coagulation Factor IX (Recombinant)] Lyophilized Powder for Solution for Intravenous Injection is a coagulation factor IX (recombinant) indicated in adults and children ≥ 12 years of age with hemophilia B for control and prevention of bleeding episodes, and for perioperative management. IXINITY is not indicated for induction of immune tolerance in patients with hemophilia B. IXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein.
Hypersensitivity reactions, including anaphylaxis, may occur following IXINITY administration. Discontinue use of IXINITY if hypersensitivity symptoms occur and initiate appropriate treatment. Regularly evaluate patients for the development of factor IX inhibitors by appropriate clinical observations and laboratory tests. If expected factor IX activity plasma levels are not attained, or, if bleeding is not controlled as expected with a certain dose, perform an assay that measures factor IX inhibitor concentration. An association between the occurrence of a factor IX inhibitor and allergic reactions has been reported. Individuals with factor IX inhibitors may be at increased risk of severe hypersensitivity reactions or anaphylaxis if re-challenged.
Nephrotic syndrome may occur with IXINITY. Nephrotic syndrome has been reported following attempted immune tolerance induction in hemophilia B patients with factor IX inhibitors and a history of allergic reactions. Thromboembolism may occur when using IXINITY (e.g., pulmonary embolism, venous thrombosis, and arterial thrombosis). Patients may develop hypersensitivity to hamster (CHO) protein as IXINITY contains trace amounts. The most common adverse drug reaction observed in >2% of patients in clinical trials was headache.
Please see full Prescribing Information at www.IXINITY.com.
About Aptevo Therapeutics Inc.
Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on developing novel immunotherapies for the treatment of cancer. The Company's lead clinical candidate, APVO436, and preclinical candidates, ALG.APV-527 and APVO603 were developed based on the Company's versatile and robust ADAPTIR™ modular protein technology platform. The ADAPTIR platform is capable of generating highly differentiated bispecific antibodies with unique mechanisms of action for the treatment of different types of cancer. For more information, please visit www.aptevotherapeutics.com
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including, without limitation, statements regarding potential milestone payments, Aptevo's outlook, financial performance or financial condition, Aptevo's technology and related pipeline, collaboration and partnership opportunities, commercial portfolio, milestones, and any other statements containing the words "believes," "expects," "anticipates," "intends," "plans," "forecasts," "estimates," "will" and similar expressions are forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not undertake to update any forward-looking statement to reflect new information, events or circumstances.
There are a number of important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; adverse developments in research and development; adverse developments in the U.S. or global capital markets, credit markets or economies generally; and changes in regulatory, social and political conditions. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, as filed on March 18, 2019 and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement.
Senior Director, Investor Relations and Corporate Communications
SOURCE: Aptevo Therapeutics