Aptevo Therapeutics Highlights Key 2019 Priorities
08 January 2019 - 12:30AM
ADAPTIR™ Bispecific Antibody Candidates Poised to
Progress in Clinical Development
Aptevo Therapeutics Inc. (Nasdaq: APVO), a biotechnology
company focused on developing novel oncology and hematology
therapeutics, today outlined key priorities for the Company in 2019
centered around anticipated progress in its ADAPTIR bispecific
antibody portfolio, new growth initiatives for its marketed
hemophilia B product, IXINITY, and a significant reduction in
Aptevo’s anticipated cash burn rate in 2019.
“The past year represented a period of solid
execution for Aptevo as we delivered on our goal of advancing our
ADAPTIR platform to have key programs progressing in the clinic in
2019,” said Marvin L. White, President and Chief Executive
Officer. “Most notably our lead next-generation ADAPTIR
candidate, APVO436, commenced patient dosing in the fourth quarter
of 2018 and we expect to begin enrollment in a Phase 1 clinical
study of APVO210 this quarter. In addition, in conjunction
with our partner, Alligator Bioscience, we expect to file a
Clinical Trial Authorisation submission (CTA) later this year in
Europe to commence a Phase 1 study of ALG.APV-527, an exciting
bispecific candidate that engages T cells through the
co-stimulatory receptor, 4-1BB, illustrating the versatility of our
ADAPTIR platform to develop novel bispecifics with unique
mechanisms of action. We look forward to advancing each of
these programs in 2019 and reporting preliminary safety and
efficacy data as enrollment progresses.”
“Our commercial organization has also been very
successful expanding our IXINITY business,” continued Mr. White.
“With U.S. sales more than doubling in 2018 to approximately $23
million, Aptevo announced new growth initiatives which we plan to
implement in 2019 to further expand the market opportunity for
IXINITY in the U.S. and internationally. These include, seeking a
pediatric label expansion for IXINITY, as more than a third of
patients with Hemophilia B in the U.S. are under the age of 13;
introducing a more desirable and convenient 3,000 IU assay for
patients, and finally, pursuing ex-US licensing and partnership
opportunities for IXINITY to expand our footprint
internationally.”
“We project our cash burn rate in 2019 will be
in the range of $36-40 million compared to $55-60 million in 2018.
The three major elements contributing to this reduction are (i) the
completion of clinical trial manufacturing activities for both the
APVO436 and APVO210 in 2018; (ii) increased IXINITY profitability
anticipated in 2019; and (iii) the previously announced
discontinuation of our legacy programs. With this reduction
in our cash requirements, combined with our current cash at
year-end of $38 million, the cash flow anticipated from IXINITY,
along with the proceeds we may elect to access under our $35
million share purchase agreements with Lincoln Park Capital, we
believe Aptevo is well positioned to advance our objectives and
reach important clinical milestones over the next 12-18 months,
setting the stage for an important value creation period.”
concluded Mr. White.
Key 2019 Priorities:
Advance 3 products in the clinic over
the next 18 months
- Continue enrollment in the Phase 1 clinical trial of APVO436,
being investigated for the treatment of acute myeloid leukemia
- Commence dosing in the Phase 1 clinical trial of APVO210
investigating single- and multiple-ascending doses of APVO210;
anticipated to commence Q1 2019
- Report preliminary Phase 1 safety data for APVO436; anticipated
Q4 2019
- Report preliminary Phase 1 safety data for APVO210; anticipated
Q4 2019
- File a CTA in Europe for ALG.APV-527, in co-operation with our
partner Alligator Bioscience; anticipated H2 2019
Drive growth of IXINITY
- Capture increased market share of Hemophilia B market with
expanded U.S. sales of IXINITY
- Commence a post-marketing Phase 4 study of IXINITY in pediatric
patients; anticipated Q3 2019
- Launch a 3,000 IU assay of IXINITY providing enhanced patient
convenience; anticipated Q2 2019
Pursue partnerships for our assets
- Continue partnering discussions around the ADAPTIR platform and
individual bispecific product candidates
- Commence distributor/partnership discussions around ex-US
IXINITY opportunities
Mr. White continued, “With the exception of our
ALG.APV-527 program, partnered with Alligator Bioscience, all of
the clinical and preclinical assets in our portfolio are
wholly-owned by Aptevo, providing important opportunities for value
creation for stockholders. I am very excited about the
opportunities ahead for Aptevo in 2019 as we continue to grow sales
of IXINITY and advance a compelling and differentiated bispecific
technology platform, ADAPTIR, as our next-generation candidates
advance in clinical testing and reach important clinical
milestones.”
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® coagulation factor IX
(recombinant), 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
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, 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 13, 2018 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.
Source: Aptevo Therapeutics Stacey
JurchisonSenior Director, Investor Relations and Corporate
Communications206-859-6628 | JurchisonS@apvo.com
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