Provides Significant Non-Dilutive Funding to Execute R&D Strategy
Sharpens Focus on Proprietary ADAPTIR™ Protein Therapeutic Platform
Retains IXINITY®
Commercial Asset
SEATTLE, Aug. 31, 2017 (GLOBE NEWSWIRE) -- Aptevo Therapeutics Inc. (Nasdaq:APVO), a biotechnology company
focused on developing novel immuno-oncology and hematology therapeutics, today announced that it has agreed to sell its three
marketed hyperimmune products, WinRho® SDF, HepaGam B®, and VARIZIG®, to Saol Therapeutics for
total consideration of up to $74.5 million.
Under the terms of a definitive purchase agreement executed by the companies, Saol Therapeutics will acquire the
three hyperimmune products currently 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, 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 collection of certain accounts receivable after the
closing.
“We’re extremely pleased to announce our agreement with Saol Therapeutics for the sale of our hyperimmune
commercial products. The significant non-dilutive funding provided by this transaction will ensure that Aptevo continues to be
solidly capitalized to invest in the opportunities where we see the most potential for long-term value creation for our
stockholders,” said Marvin L. White, President and Chief Executive Officer. “With a deal value of up to $74.5 million,
representing approximately 2.8 times both our current market capitalization on August 30, 2017 and our 2016 annual revenue, we view
this as a very attractive opportunity to monetize our non-core assets and not dilute our stockholders as we continue to invest in
promising assets like our ADAPTIR™ platform.”
“Our ADAPTIR platform has generated a rich pipeline of novel immunotherapeutic candidates targeting oncology and
autoimmune indications. With bispecific antibodies gaining increasing recognition in the scientific and financial communities
as the ‘next-generation’ of therapeutic antibodies, we believe that continued investment in this promising technology platform may
yield enhanced value for our stockholders. Importantly, this transaction strengthens Aptevo’s cash position and provides us
the necessary resources to continue to advance our ADAPTIR product candidates through potentially value-adding inflection points,
including an ongoing dose-escalation Phase 1 study of APVO414 in metastatic castration resistant prostate cancer; an ongoing
Phase 2 clinical program for otlertuzumab, and future Phase 1 clinical studies of our novel bispecifics focused on engaging the
immune system, including, APVO436 and ALG.APV-527, a bispecific targeting ROR1, and a bispecific based on targeted cytokine
delivery, APVO210 (formerly known as ES210.)”
The transaction, which is expected to be completed in 2017, is subject to certain customary closing
conditions. Piper Jaffray & Co. served as exclusive financial advisor to Aptevo for this transaction. Aptevo
anticipates that proceeds from the sale of the three hyperimmune products will be used to (i) satisfy its current debt obligation
to MidCap Financial, and (ii) advance its clinical and preclinical ADAPTIR candidates.
In addition to its three marketed hyperimmune products, WinRho SDF, HepaGam B, and VARIZIG, which are the
subject of the agreement with Saol Therapeutics, Aptevo owns and markets IXINITY®, an intravenous recombinant factor IX
therapeutic for use in people with Hemophilia B.
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.
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. The Company has four commercial products – IXINITY®,
WinRho® SDF, HepaGam B® and VARIZIG® 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 bispecific 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
the closing of the anticipated sale of the hyperimmune products to Saol Therapeutics, Aptevo’s use of proceeds from such
transaction, Aptevo’s outlook, financial performance or financial condition, Aptevo’s technology and related pipeline,
collaboration and partnership opportunities, commercial portfolio, Aptevo’s future growth rates, Aptevo’s ability to timely
manufacture its products, 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 uncertainties as to the satisfaction of closing conditions with respect to
the transaction; closing of the transaction may not occur or may be delayed, either as a result of litigation related to the
transaction or otherwise; possible negative effects on Aptevo’s business operations, assets or financial results as a result 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 Jurchison Senior Director, Investor Relations and Corporate Communications 206-859-6628 JurchisonS@apvo.com