Cytori Therapeutics, Inc. (Nasdaq: CYTX) (the “company”) announced
yesterday a new direction and identity.
Since the beginning of 2019, the company has successfully
evaluated and transformed its pipeline to place a stronger emphasis
on product candidates that can maximize returns for shareholders
and make a clinically meaningful impact for patients. Plus
Therapeutics, Inc. plans to create and realize this value by
developing drugs for niche and orphan markets, initially in
oncology, that address significant unmet or substantially
underserved medical needs and that represent global revenue
opportunities estimated to be $250 million or more. We intend to
focus our development activities in ways that can leverage the U.S.
FDA’s accelerated regulatory pathways and enable the company to
apply its in-house expertise in nanoparticle drug design, complex
formulation, and drug manufacturing and scale-up.
“Our core development concept will be to combine known active
pharmaceutical ingredients, or drugs, with new delivery approaches
and/or formulations, resulting in innovative therapies with
improved safety, efficacy, and/or convenience,” said Marc H.
Hedrick MD, President and CEO.
The company’s initial development focus will be on DocePLUS
(formerly ATI-1123) -- a complex, injectable, patented,
albumin-stabilized pegylated liposomal docetaxel -- for which a
U.S. Phase 1 clinical trial has been completed and published. The
company has previously announced that it has received feedback from
the U.S. FDA that a 505(b)(2) new drug application appears to be an
acceptable regulatory approach for DocePLUS. Plus Therapeutics
intends to submit a Phase 2 clinical trial protocol in Small Cell
Lung Cancer patients with platinum-sensitive disease who progressed
at least 60 days after initiation of first-line chemotherapy to the
U.S. FDA in the second half of 2019.
Coinciding with this new focus on DocePLUS, the company has
determined that DoxoPLUS (formerly ATI-0918) –- a generic pegylated
liposomal doxorubicin -- no longer satisfies the aforementioned
development and revenue criteria. As a result, we have elected to
focus on divesting DoxoPLUS and are currently presenting this
opportunity to external parties.
To complement and reinforce the new company direction, a new
company brand will be established. We have created, designed, and
launched a new company visual identity, mission, vision, values,
website, and social media sites based on the brand promise of
‘Delivering More For Patients’.
“We took a holistic approach to branding the company under the
new Plus Therapeutics name,” said Russ Havranek, Vice President,
Marketing and Portfolio Management. “We believe that Plus
Therapeutics will clearly align, drive, and navigate the business
forward, ultimately helping patients who are battling cancer and
other life-threatening diseases.”
The company has reserved a new stock symbol, PSTV, and plans to
submit notice of the company name change to the Nasdaq Stock
Exchange. We expect to trade under the new symbol within the next
few weeks. Until then, the company intends to continue to trade on
Nasdaq under its current stock symbol, CYTX.
About Plus Therapeutics, Inc.
Plus Therapeutics is a clinical-stage pharmaceutical company
focused on making a positive impact on patients’ lives and adding
value to the healthcare system. We are a Nasdaq-listed company with
our company headquarters located in Austin, TX. We also have a
manufacturing facility in San Antonio, TX and a satellite office in
San Diego, CA.
The lead product candidate in our pipeline, DocePLUS, is being
developed in the U.S. by a dedicated and energetic team of
biologists, chemists, engineers, and other professionals. This
diverse and experienced team is using our proprietary and versatile
nanotechnology platform in an effort to reformulate and improve
conventional, workhorse chemotherapeutics to provide meaningful
benefits to patients and healthcare providers. The platform also
serves as the foundation and affords us the opportunity in the
future to develop additional drugs for oncology and other
therapeutic areas.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains certain statements that may be
deemed “forward-looking statements” within the meaning of U.S.
securities laws. All statements, other than statements of
historical fact, that address activities, events or developments
that we intend, expect, project, believe or anticipate and similar
expressions or future conditional verbs such as will, should,
would, could or may occur in the future are forward-looking
statements. Such statements are based upon certain assumptions and
assessments made by our management in light of their experience and
their perception of historical trends, current conditions, expected
future developments and other factors they believe to be
appropriate.
These statements include, without limitation, statements about
our plans to develop DocePLUS, including our intention to submit a
Phase 2 clinical trial protocol; the company’s plan to develop
drugs for niche and orphan markets; the company’s intention to
focus development activities in ways that can leverage the U.S.
FDA’s accelerated regulatory pathways; the company’s core
development concept and initial development focus; the potential
divestiture of DoxoPLUS; the potential size of the market for our
product candidates; future development and/or expansion of our
product candidates and therapies in our markets; our ability to
generate product or development revenues and the sources of such
revenues; our ability to obtain and maintain regulatory approvals;
the timing of the company’s change in trading symbol. Our actual
results will likely differ, perhaps materially, from those
anticipated in these forward-looking statements as a result of
various factors, including: the early stage of our product
candidates and therapies, the results of our research and
development activities, including uncertainties relating to the
clinical trials of our product candidates and therapies; our need
and ability to raise additional cash, the outcome of our
partnering/licensing efforts, risks associated with laws or
regulatory requirements applicable to us, market conditions,
product performance, potential litigation, and competition within
the regenerative medicine field. The forward-looking statements
included in this press release are subject to a number of
additional material risks and uncertainties, including but not
limited to the risks described under the “Risk Factors” in the
company’s Securities and Exchange Commission filings, included in
the company’s annual and quarterly reports.
There may be events in the future that the company is unable to
predict, or over which it has no control, and its business,
financial condition, results of operations and prospects may change
in the future. The company assumes no responsibility to update or
revise any forward-looking statements to reflect events, trends or
circumstances after the date they are made unless the company has
an obligation under U.S. Federal securities laws to do so.
Plus Therapeutics, Inc.
Phone:
+1.737.255.7194Email: ir@plustherapeutics.comWebsite: plustherapeutics.com
Source: Plus Therapeutics, Inc.
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