APVO Aptevo Therapeutics Inc

Sharpens Focus on Innovative ADAPTIR® Bispecific Antibody Platform and IXINITY® Commercial Asset

Aptevo Therapeutics Inc. (Nasdaq:APVO), a biotechnology company focused on developing novel immuno-oncology and hematology therapeutics, today announced that it has completed the sale of three of its marketed products (WinRho® SDF, HepaGam B®, and VARIZIG®) to Saol Therapeutics for total consideration of up to $74.5 million.

Under the terms of a purchase agreement between the companies, Saol Therapeutics has acquired three hyperimmune products previously marketed by Aptevo: WinRho SDF for autoimmune platelet disorder and hemolytic disease of the newborn; HepaGam B for the prevention of Hepatitis B following liver transplantation and for treatment following hepatitis B exposure; and VARIZIG for treatment following exposure to varicella zoster virus for individuals with compromised immune systems.  

The transaction is valued at up to $74.5 million, including an upfront payment of $65 million ($3.25 million of which was placed in an escrow account), and an additional potential milestone payment of up to $7.5 million related to the achievement of gross profit milestones.  In addition, Aptevo may receive up to $2 million related to the collection of certain accounts receivable.

“The sale of our hyperimmune products is a transformative event for Aptevo that positions us well for future value creation by strengthening our financial position and sharpening our focus on our most promising commercial and pipeline assets,” said Marvin L. White, President and Chief Executive Officer.  “I am very excited about the future of Aptevo for good reason. We are in the enviable position of having a commercial product (IXINITY®) with growth potential; a robust, leading-edge protein therapeutic platform technology (ADAPTIR™) targeting immuno-oncology and autoimmune diseases; multiple novel bispecific antibody candidates advancing in clinical and preclinical development; and finally, a wholly-owned portfolio of assets with the optionality to potentially generate value from these assets through future corporate partnerships.  I feel very good about the hand we are holding, and the opportunities ahead for Aptevo and our stockholders.” 

“Our core technology – the ADAPTIR platform, is among a new class of targeted, antibody-based therapeutics that hold promise for the treatment of cancer and other chronic diseases through the simultaneous targeting of two or more distinct epitopes, activating and engaging the immune system to fight cancer, or, in some cases, suppressing the immune response to decrease inflammation.  With bispecifics gaining increasing momentum as a promising new class of “off-the-shelf” engineered therapeutics, Aptevo is now better capitalized and positioned to advance our bispecific pipeline and build value for our stockholders.  We are excited about the unique features of our technology platform, and with second generation ADAPTIR candidates heading towards the clinic, the opportunity to establish Aptevo as a premier company focused on the next generation of antibody-mediated therapeutics for the treatment of cancer and autoimmune diseases,” concluded Mr. White. 

Aptevo Portfolio: Commercial and Investigational Products

• IXINITY® – an intravenous recombinant factor IX therapeutic for use in people with Hemophilia B – a hereditary bleeding disorder characterized by a deficiency of clotting factor IX in the blood, which is necessary to control bleeding.  IXINITY was launched in 2015 and is marketed in the United States by Aptevo.

• APVO414 – a bispecific ADAPTIR candidate, currently in Phase 1 development, targeting prostate specific membrane antigen (PSMA), an enzyme that is expressed on the surface of prostate cancer cells, and, CD3, a component of the T cell receptor complex expressed on all T cells.  APVO414 redirects T cells to specifically kill PSMA expressing tumors and is being developed for metastatic castration-resistant prostate cancer, which is advanced prostate cancer that has spread to other organs and no longer responds to hormone blocking therapies.

• Otlertuzumab – a monospecific ADAPTIR candidate currently in Phase 2 development for the treatment of chronic lymphocytic leukemia (CLL).  Data from a Phase 2 clinical trial evaluating otlertuzumab in combination with bendamustine, compared to bendamustine alone, demonstrated a significant increase in median progression free survival for the combination, from approximately 10 to 16 months.

• APVO436 – a bispecific ADAPTIR candidate currently in preclinical development targeting CD123, a cell surface receptor highly expressed on several hematological malignancies and CD3, a component of the T-cell receptor. APVO436 is designed to engage T cells to kill tumor cells.

• ALG.APV-527 – a bispecific antibody candidate, partnered with Alligator Bioscience, featuring a novel mechanism of action designed to simultaneously target 4-1BB (CD137) and an undisclosed tumor antigen.  4-1BB, a costimulatory receptor on T cells, is known to enhance the immune response to cancer through activation of tumor-specific T cells and is believed to be a promising target for new immunotherapeutic approaches. ALG.APV-527 could potentially have utility in the treatment of a broad spectrum of cancers over-expressing the tumor antigen, including breast, cervical, non-small-cell-lung, prostate, renal, gastric, colorectal and bladder cancers.

• APVO210 – a bispecific ADAPTIR preclinical candidate with a novel mechanism of action based on targeted cytokine delivery.  APVO210 is composed of a humanized anti-CD86 antibody fused with a modified form of IL-10 that specifically induces IL-10 signaling on antigen presenting cells, but not on lymphoid populations. APVO210 functions by suppressing immune responses and inducing certain tolerogenic responses and therefore may have potential benefit for the treatment of autoimmune and inflammatory diseases.

• ROR1 Bispecific – a proof-of-concept bispecific candidate targeting ROR1, an antigen found on several solid tumors and hematologic, or blood-related malignancies.  Initial preclinical data demonstrate redirected T cell killing of tumors expressing ROR1 in vitro and in vivo in animal models.

Piper Jaffray & Co. served as exclusive financial advisor to Aptevo for this transaction.

About Aptevo Therapeutics Inc.

Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on novel oncology and hematology therapeutics to meaningfully improve patients’ lives.  Aptevo has a commercial product, IXINITY®, approved and marketed in the United States for the treatment of Hemophilia B, and a versatile core technology – the ADAPTIR™ modular protein technology platform capable of generating highly-differentiated bispecific antibodies with unique mechanisms of action to treat cancer or autoimmune diseases.  Aptevo has two ADAPTIR antibody candidates currently in clinical development and a broad pipeline of novel investigational-stage bispecific antibody candidates focused in immuno-oncology and autoimmune disease and inflammation. 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, 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 possible negative effects on our business operations, assets or financial results as a result of the closing of the transaction;; a deterioration in Aptevo’s business or prospects; the parties may be unable to achieve the anticipated benefits of the transaction; 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 31, 2017, 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.

For Further Information:

Aptevo Therapeutics Stacey JurchisonSenior Director, Investor Relations and Corporate Communications206-859-6628 JurchisonS@apvo.com