On July 16, 2019 Cytori Therapeutics, Inc. (Nasdaq: CYTX) (the "company") reported a new direction and identity (Press release, Cytori Therapeutics, JUL 16, 2019, View Source [SID1234572285]).
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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.