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Cytori Divests "Cell Therapy Assets" For $7M.

But Is Holding On To Other Cell Therapy R&D Programs

SAN DIEGO, Calif., April 23, 2019 -- Longtime stem cell research firm Cytori Therapeutics (NASDAQ: CYTX) announced another sale of cell therapy assets, this time to Seijiro Shirahama of Tokyo, Japan, yielding $3 million in non-dilutive funding to the company.

The company's cell therapy programs are based on cells derived from a person's adipose (fat) tissue.

The announcement follows an April 1, 2019, sale of some cell therapy assets to Lorem Vascular of Melbourne, Australia, yielding $4 million in non-dilutive funding.

In 2013, Cytori granted Lorem Vascular a 30-year exclusive license to its Cytori Cell Therapy technology for all clinical indications (except hair applications) for Australia, China, Hong Kong, Malaysia, and Singapore.

In 2015, Cytori and Lorem Vascular announced that China FDA had granted regulatory clearance for the Cytori Celution System.

"This cell therapy asset sale strengthens the company's ability to achieve a number of important objectives, including enabling us to focus on our clinical stage oncology pipeline while bringing in additional non-dilutive capital," said CEO Marc Hedrick.

The divestiture means Cytori will focus most of its resources on its lead clinical stage asset, ATI-0918, a potential therapy for breast and ovarian cancer, multiple myeloma, and Kaposi's sarcoma.

In 2017, Cytori acquired a nanomedicine platform technology that combines the chemotherapy agents doxorubicin and docetaxel with liposomal encapsulation technology.

"Our current development program is focused in Europe where we believe there is a potential market opportunity of $120 million annually," Hedrick said.

In Q1 2019, Cytori submitted a letter of intent to file a marketing authorization application (MAA) to the European Medicines Agency (EMA) for ATI-0918.

ATI-0918 is being developed as a generic version of Janssen's Caelyx pegylated liposomal doxorubicin.

The company continues to evaluate potential development and commercialization partnering opportunities for ATI-0918 with a focus on Europe and China.

European approval and launch of ATI-0918 is projected to be in late 2020.

A second clinical stage oncology-focused asset is ATI-1123, a phase 2-ready, patented, albumin-stabilized pegylated liposomal docetaxel.

In 2018, the company received an orphan drug designation from the FDA for the indication of small cell lung cancer and is pursuing a 505(b) (2) new drug application (NDA) pathway in the U.S. which may offer an accelerated clinical timeline and lower development cost.

The company said it is exploring near term development strategies and intends to advance this program aggressively in 2019.

Shifting Its Primary Focus?

Cytori seems to be shifting its strategic focus away from cell therapies after 17 years, though it maintains an interest in at least two ongoing programs, one of which is in Japan.

Some signs of the shift away from cell therapy: In a January 31 press release, Cytori described itself as

"...a therapeutics company developing regenerative and oncologic therapies from its proprietary cell therapy and nanoparticle platforms for a variety of medical conditions.

"Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy acts principally by improving blood flow, modulating the immune system, and facilitating wound repair.

"As a result, Cytori Cell Therapy may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori's proprietary technologies and products." [Emphasis added]

In a November 2018 release announcing 3rd quarter (2018) financial results, CEO Hedrick said:

"In cell therapy, we are focused on continued revenue growth based on positive quarter-over -quarter and year-over-year consumable utilization trends. In the meantime, we are awaiting pivotal clinical data from our Japanese stress urinary incontinence trial."

In announcing its most recent financial results (April 1), Hedrick emphasized its oncology-focused programs, but said it would continue to focus on certain cell therapy research and development, especially in Japan:

"We also are able to maintain our most valuable cell therapy assets, including Japan, that has a forthcoming trial readout in our ADRESU trial...

"Cytori's ADRESU pivotal urinary incontinence trial using Cytori Cell Therapy has completed enrollment and anticipates data read out in the second quarter of 2019.

"If the data [are] positive, Cytori intends to seek expedited approval and reimbursement for the Japanese market for this indication.

"In Q1 2019, Cytori received approval from the United States Food & Drug Administration to expand the enrollment criteria for its RELIEF clinical trial of intravenously delivered Cytori Cell Therapy for patients with severe burn injuries."

However, in its latest release the company no longer talked about cell therapy.

Instead, it says:

"Cytori is developing, manufacturing, and commercializing nanoparticle-delivered oncology drugs within its nanomedicine franchise.

"Cytori Nanomedicine is focused on the liposomal encapsulation of anti-neoplastic chemotherapy agents, which may enable the effective delivery of the agents to target sites while reducing systemic toxicity.

"The Cytori Nanomedicine product pipeline consists of ATI-0918, a pegylated liposomal doxorubicin hydrochloride for breast cancer, ovarian cancer, multiple myeloma, and Kaposi's sarcoma, a complex/hybrid generic drug, and ATI-1123 patented albumin-stabilized pegylated liposomal docetaxel for multiple solid tumors."

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Publication:Stem Cell Business News
Date:Apr 29, 2019
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