Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”) today issued
the following Letter to Shareholders from Dr. Marc Hedrick,
President and Chief Executive Officer.
January 6, 2020
To Our Loyal Stockholders:
All of us at Plus Therapeutics wish you and yours a healthy and
productive new year. We greatly appreciate your dedication to
this company over the years and we are confident that 2020 will
demonstrate that your loyalty was well-placed.
As we emerge from a successful transitional year for the
company, we enter 2020 with a clear mission, expansive vision, and
straightforward development model. Plus Therapeutics is on a
mission to discover, develop and deliver complex and innovative
treatments for patients battling cancer and rare diseases.
This mission is designed to fulfill our vision of introducing
medicines that drastically enhance clinical and economic outcomes
for patients and providers – and dramatically improve human health
worldwide. Our development model starts with a proven drug
and applies new delivery and formulation innovations to unlock and
achieve new clinical applications for or improved safety and
efficacy of the proven drug.
We are pleased to say that we have positioned ourselves to
fulfill that vision beginning this year. We have a sharp
focus on drugs that can be developed cost-effectively and
efficiently. We are quickening our business pace, in part, by
utilizing U.S. FDA regulatory pathways such as the 505(b)(2) New
Drug Application, designed to streamline development of
pharmaceutical products that incorporate already-approved
pharmacological agents. And we are leveraging our core
expertise in drug reformulation through nanoparticle encapsulation
and delivery of proven workhorse oncology drugs.
At the same time, we have re-architected this company for
growth. As I have said recently:
“Plus Therapeutics emerges from 2019 with the financial
strength, development focus and cost structure to achieve long-term
viability and growth. This company is now poised to convert its
development vanguard position into market leadership. We are
confident that our expanding pipeline can produce extraordinary
drugs that provide tremendous benefits to patients and shareholders
alike.”
I am extremely proud of our team, which worked tirelessly in
2019 to bring us to this point. In quick succession, during
the second half of 2019 this company:
- Reinvented as a clinical-stage pharmaceutical company focused
on oncology and rare disease;
- Achieved long-term viability in a rapid burst of financial
milestones, adding approximately $26 million to the balance sheet
through a series of transactions including the sale of non-core
assets, a $4.6 million reimbursement from the U.S. Department of
Health and Human Services for our work on our BARDA contract, and a
$15 million public offering;
- Moved our corporate headquarters from California to the
lower-cost/lower-tax/incentive-friendly state of Texas, whose
Cancer Prevention & Research Institute is the largest public
funder of cancer research in the U.S. after the federal government;
and
- Right-sized into a lean organization built-for-scale at
sustainable margin.
Our nanotechnology platform is designed to generate enhanced
delivery of drugs using novel liposomal encapsulation technology.
Our lead product candidate, DocePLUS, is a protein-stabilized
PEGylated liposomal formulation of docetaxel, for which the process
of preparation is patented. The active pharmaceutical
ingredient, docetaxel, was approved by the U.S. FDA in 1999 and
commonly used for treating cancers of the breast, head, neck,
stomach, prostate, and lung. Further, we are looking to
divest another pipeline product candidate, DoxoPLUS, PEGylated
liposomal doxorubicin, a generic version of CAELYX, used for the
treatment of ovarian and breast cancers.
In 2019, we received positive pre-IND feedback from U.S. FDA,
and we believe strongly that there is a path forward for our
DocePLUS product candidate. We expect to finalize our Phase 2
clinical protocol with U.S. FDA in the 1st half of 2020 and treat
the first patients in the 2nd half of 2020.
The portfolio is designed to put the “plus” in PLUS. Each
of our drug candidates must meet three basic criteria:
1) Addresses an unmet or substantially underserved medical
need;
2) Deploys new technologies to more safely and effectively
deliver known active pharmaceutical ingredients that have extensive
pre-existing safety and efficacy information; and
3) Serves an addressable global market opportunity of at least
$250 million annually.
Please stay tuned in 2020 for potential additions to our
portfolio.
Once again, I offer our heartfelt thanks – to our team, to our
Board, to our partners and to our shareholders. We are grateful for
your continued support. And we look forward to an excellent
year in 2020.
Sincerely,
Dr. Marc HedrickPresident and Chief Executive Officer
About Plus Therapeutics, Inc.
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical
company focused on the discovery, development, and manufacturing
scale up of complex and innovative treatments for patients battling
cancer and other life-threatening diseases.
Our proprietary nanotechnology platform is currently centered
around the enhanced delivery of a variety of drugs using novel
liposomal encapsulation technology. Liposomal encapsulation has
been extensively explored and undergone significant technical and
commercial advances since it was first developed. Our platform is
designed to facilitate new delivery approaches and/or formulations
of safe and effective, injectable drugs, potentially enhancing the
safety, efficacy and convenience for patients and healthcare
providers.
Our lead product candidate, DocePLUS, is a protein-stabilized
PEGylated liposomal formulation of docetaxel, for which the process
of preparation is patented. The active pharmaceutical ingredient,
docetaxel, was approved by the U.S. FDA in 1999 and commonly used
for treating cancers of the breast, head, neck, stomach, prostate,
and lung. More information may be obtained at
plustherapeutics.com.
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: the Company’s belief that that its expanding
pipeline can produce extraordinary drugs that provide tremendous
benefits to patients and shareholders alike; the Company’s plans to
divest another pipeline product candidate, DoxoPLUS; the Company’s
expectations regarding finalizing its Phase 2 clinical protocol
with U.S. FDA in the 1st half of 2020 and treat the first patients
in the 2nd half of 2020; the Company’s potential to facilitate new
delivery approaches and/or formulations of safe and effective,
injectable drugs, potentially enhancing the safety, efficacy and
convenience for patients and healthcare providers; and the
Company’s potential to substantially improve the lives of patients
battling cancer and rare diseases. 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 risk that the U.S. FDA does not accept the
Company’s submission of a Phase 2 clinical trial protocol; the risk
that the Company is not able to successfully develop product
candidates that can leverage the U.S. FDA’s accelerated regulatory
pathways; the ability of the Company to raise additional capital to
meet the Company’s business operational needs and to achieve its
business objectives and strategy; the Company’s ability to project
future capital needs and cash utilization; future clinical trial
results; that the results of studies and clinical trials may not be
predictive of future clinical trial results; the sufficiency of
intellectual property protection; risks related to the drug
development and the regulatory approval process; the competitive
landscape and other industry-related risks; and the risks described
under the heading “Risk Factors” in the Company’s Securities and
Exchange Commission filings, including 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. Russ Havranek VP
– Marketing, Portfolio Management, Investor Relations Phone:
+1.619.333.4150 Email: ir@plustherapeutics.com
Website: plustherapeutics.com
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