PSTV Plus Therapeutics Inc

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