Ambrx Biopharma Inc. Announces Strategic Reprioritization and Provides Corporate Update
October 18 2022 - 4:05PM
Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage
biopharmaceutical company using an expanded genetic code technology
platform to create Engineered Precision Biologics (EPBs), today
announced a strategic reprioritization of its pipeline and provided
a corporate update. The strategic assessment considered the
company’s cash runway, pipeline near term value creation
opportunities, and other factors. As part of this strategic update,
Ambrx will streamline its organization to improve efficiency and
reprioritize its development pipeline to focus on oncology assets
with the greatest potential and strong competitive profiles.
"The tough decisions we are announcing today
will streamline Ambrx’s operations and provide us with the
resources to pursue our development candidates that hold the
greatest promise for success in people with cancer,” said Kate
Hermans, Interim Chief Executive Officer of Ambrx. “There has been
a significant shift this past year in the HER2 metastatic breast
cancer competitive landscape. As a result of our assessment, the
Board has endorsed the decision that the company should pause the
internal development of ARX788 and seek a partner to further its
development ex-China in order to extend the cash runway into 2025.
Ambrx will focus on strengthening its current partnerships, while
forging new collaborations to progress both ARX788 and other
pipeline assets, in various indications. In parallel, we will
concentrate our internal development on earlier stage programs
where we believe Ambrx offers a first-in-class or best-in-class
approach, including our now lead candidate ARX517, which has the
potential to be the first Prostate-Specific Membrane Antigen
(PSMA)-targeting ADC.”
Ms. Hermans continued, “As a result of today’s
reprioritization, management expects Ambrx now has sufficient
capital to fund operations into 2025. We believe these changes
position Ambrx for future success and reflect both our confidence
in the company’s EPB platform and our commitment to building
shareholder value. We look forward to executing on this new
strategy and providing further updates in due course.”
“I am pleased that the Board and management of
Ambrx have aligned on a strategic path forward as we navigate
through the highly competitive oncology market,” said Katrin
Rupalla, Chair of Ambrx’s Board of Directors. “We believe that
prioritizing our play-to-win ADC assets will put Ambrx in the best
position to maximize shareholder value and improve the lives of
people with cancer. I would like to thank all our employees and
partners for their hard work, patience and tenacity as we work
through these changes and toward an encouraging future for our
patients and stakeholders.”
Pipeline Update
In mid-August 2022, Ambrx announced that it
would undertake a strategic review of its clinical development
pipeline. Moving forward, the company plans to focus on leveraging
its novel antibody-engineering technology to target cancer
indications. Specifically, Ambrx has developed a proprietary,
site-specific conjugation platform that provides homogenous ADCs
with unmatched stability. With a narrower scope, Ambrx believes it
is better positioned to progress future ADC assets.
- Ambrx will prioritize the
progression of ARX517 through the clinic as the company’s new lead
asset. The company believes ARX517 has the potential to be the
first ADC therapy that specifically targets Prostate Specific
Membrane Antigen (PSMA) to treat prostate cancer. Prostate cancer
represents a significant unmet medical need with 1.4 million new
cases worldwide in 2020, representing an estimated $9.9 billion
market. In August 2021, Ambrx announced the first patient was dosed
with ARX517 in a Phase 1a clinical trial in subjects with
PSMA-expressing tumors.
- Due to changes in the HER2
competitive landscape, Ambrx will no longer directly pursue our
anti-HER2 antibody-drug conjugate (ADC) asset ARX788 as its lead
clinical asset. As such, the company will pause development of
Ambrx-sponsored clinical trials involving ARX788. Instead, Ambrx
will continue to work collaboratively with NovoCodex and seek a
development partner(s) ex-China to progress ARX788.
- Ambrx highly values its global
partners and plans to continue working collaboratively with
NovoCodex (ARX788, ARX305), Sino Biopharm (ARX102) and BeiGene
(research collaboration).
- Additional pipeline programs,
ARX305 (anti-CD70 ADC) and ARX102 (smart PEG-IL2), will continue in
development. The two assets align with Ambrx’s new development
strategy of focusing on early-stage EPBs. Ambrx will leverage
clinical data from its partners who are progressing the two assets
to inform Ambrx-sponsored clinical trials.
Anticipated Near Term Pipeline
Milestones
- 2H 2023: Ambrx sponsored globally
(U.S.) Interim Phase 1a safety data for ARX517, leading to a
recommended dose that would allow Ambrx to initiate a Phase 1b/2
trial
- 2H 2023: Initiation of Ambrx
sponsored globally (U.S.) Phase 1a trial for ARX305 (subject to
results from NovoCodex sponsored trial)
- 1H 2024: IND submission for ARX102
(subject to results from Sino Biopharm sponsored trial)
Corporate Update
- Ambrx will streamline its
organization to reflect its new pipeline development focus. The
company will reduce its workforce by approximately 15% while
retaining and attracting key talent to support the clinical
development of ARX517 and other assets.
- The company’s search for a
permanent Chief Executive Officer to lead Ambrx is ongoing. Until a
permanent CEO is designated, Kate Hermans will continue to serve as
interim CEO overseeing the company’s new strategy.
- Ambrx expects its cash, cash
equivalents and marketable securities as of June 30, 2022 to fund
operations into 2025.
Conference Call
Ambrx will host a webcast to discuss the
corporate update today, October 18, 2022 at 5:00 p.m. EST / 2:00
p.m. PST. Individuals interested in listening to the conference
call may do so by accessing the webcast link in the investor
relations section of the company’s website: www.ambrx.com. To
access the call by phone, please refer to the dial in details
provided in the event page on the “Events and Presentations” page
on the investor relations website.
About Ambrx Biopharma Inc.
(Ambrx)
Ambrx is a clinical stage biopharmaceutical
company using an expanded genetic code technology platform to
discover and develop Engineered Precision Biologics. These include
next generation antibody drug conjugates (ADCs) and other
engineered therapies to modulate the immune system. Ambrx is
advancing a focused portfolio of clinical and preclinical programs
designed to optimize efficacy and safety in multiple cancer
indications, including its lead product candidate ARX517, a
prostate-specific membrane antigen (PSMA) targeting ADC. In
addition, Ambrx has clinical collaborations with multiple partners
on drug candidates generated using Ambrx technology. For more
information, please visit www.ambrx.com.
Forward-Looking StatementsThis
press release includes certain “forward-looking statements”
intended to qualify for the “safe harbor” from liability
established by the Private Securities Litigation Reform Act of
1995, as amended. Forward-looking statements may be identified by
the words “anticipate,” believe,” “estimate,” “expect,” “intend,”
“plan,” “project,” “may,” “will,” “could,” “should,” “seek,”
“potential” and similar expressions, and include, without
limitation, express or implied statements regarding Ambrx’s beliefs
and expectations regarding the advancement and potential benefits
of its product candidates, clinical development and strategic
plans, Ambrx’s expected cash runway, the expected benefits of
Ambrx’s reprioritization, and the timing of program updates and
milestones related to its product candidates. Forward-looking
statements are based on Ambrx’s current expectations and are
subject to inherent uncertainties, risks and assumptions that are
difficult to predict. Factors that could cause actual results to
differ include, but are not limited to, those risks and
uncertainties associated with: the continuing impact of the
COVID-19 pandemic and other public health-related risks and events
on Ambrx’s business, operations, strategy, goals and anticipated
milestones; Ambrx’s ability to execute on its strategy including
with respect to the timing of its R&D efforts, initiation of
clinical trials and other anticipated milestones; risks associated
with development of novel therapeutics, including potential delays
in clinical trials and regulatory submissions and the fact that
future clinical trial results may not be consistent with
preliminary results or results from prior preclinical studies or
clinical trials; Ambrx’s ability to fund operations as anticipated;
and the additional risks and uncertainties set forth more fully
under the caption “Risk Factors” in Ambrx’s Annual Report on Form
20-F filed with the United States Securities and Exchange
Commission (SEC) on April 26, 2022, and elsewhere in Ambrx’s
filings and reports with the SEC. Forward-looking statements
contained in this press release are made as of this date, and Ambrx
undertakes no duty to publicly update or revise any forward looking
statements, whether as a result of new information, future events
or otherwise, except as may be required under applicable law.
Contacts
INVESTORSLaurence WattsManaging
DirectorGilmartin Group, LLC.619-916-7620ir@ambrx.com
MEDIAGwen SchankerAccount SupervisorLifeSci
Communications269-921-3607media@ambrx.com
Source: Ambrx
Ambrx Biopharma (NYSE:AMAM)
Historical Stock Chart
From Mar 2024 to Apr 2024
Ambrx Biopharma (NYSE:AMAM)
Historical Stock Chart
From Apr 2023 to Apr 2024