Monday, November 16, 2009

“Fate Therapeutics Raises $30 Million - Private Equity Hub” plus 4 more

“Fate Therapeutics Raises $30 Million - Private Equity Hub” plus 4 more


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Fate Therapeutics Raises $30 Million - Private Equity Hub

Posted: 16 Nov 2009 04:54 AM PST

Fate Therapeutics, a La Jolla, Calif.-based stem cell biotech company focused on cell fate control, has raised $30 million in Series B funding. OVP Venture Partners led the round, and was joined by fellow return backers ARCH Venture Partners, Polaris Venture Partners and Venrock. The company previously raised $12 million.

PRESS RELEASE

– Fate Therapeutics, Inc. announced today that it has completed a $30 million Series B financing led by OVP Venture Partners.  Joining OVP Venture Partners in the financing is a syndicate of corporate investors, including Astellas Venture Management, Genzyme Ventures and a third undisclosed corporate investor.  The three co-leaders of the Company's Series A financing, ARCH Venture Partners, Polaris Venture Partners and Venrock, also participated in the latest round of financing.  In conjunction with the funding, Carl Weissman, venture partner of OVP Venture Partners, joined the Company's board of directors.

"Fate Therapeutics has made rapid progress in advancing its pipeline of Stem Cell Modulators and in establishing the leading industrialized platform for induced pluripotent stem cell technology," said Mr. Weissman.  "We are confident that the Company's management team and its scientists will continue to identify novel mechanisms to selectively intervene in adult stem cell biology for medicine, and we believe its expert knowledge, innovative approach and advanced technologies in modulating cell fate can be leveraged across a broad therapeutic spectrum of drug discovery and development opportunities."

"The leadership of OVP, the continued support of our top-tier existing investors, and the breadth of drug development and commercialization expertise of our corporate investor syndicate creates a powerful foundation for the expansion of our stem cell biology discovery engine," said Paul Grayson, president and CEO of Fate Therapeutics.  "Target populations of adult stem cells must be exquisitely characterized and quantitated, and we are employing genomic, proteomic and epigenetic expression technologies to identify cell-specific biological mechanisms to modulate cell fate for diseases that currently have limited to no treatment options."

Fate Therapeutics is developing its lead Stem Cell Modulator, FT1050, to enhance hematopoietic stem cell (HSC) proliferation and homing.  The small molecule is currently undergoing clinical testing at the Dana Farber Cancer Institute and Massachusetts General Hospital in adult patients with hematologic malignancies, such as leukemia and lymphoma, who have undergone nonmyeloablative conditioning therapy and are in need of HSC support.  The Phase 1b study is intended to determine the safety and tolerability of introducing FT1050 during the standard course of dual umbilical cord blood transplant and will also track HSC engraftment efficiencies and patient outcomes.

The Company's discovery engine utilizes the most advanced reprogramming technologies for generating cell types of interest to elucidate disease biology and identify targets for therapeutic intervention.  Fate Therapeutics' protein-based reprogramming platform in combination with its novel small molecule conditions offers a highly efficient, non-viral, non-DNA based method to recapitulate human physiology for commercial scale drug discovery and therapeutic use.  The Company has exclusively in-licensed from The Scripps Research Institute and the Whitehead Institute for Biomedical Research an intellectual property portfolio related to induced pluripotent stem cell (iPSC) technology, including filings that date back to November 2003.  This portfolio includes the latest techniques published by Dr. Sheng Ding in October 2009, which use three small molecules to generate iPSCs in a manner that is 200 times more efficient than and twice as fast as conventional methods for reprogramming adult human cells.

"The Company is well-positioned to aggressively advance its leading iPSC technology platform for use in its own internal discovery programs as well as with strategic partners," said Scott Wolchko, chief financial officer of Fate Therapeutics.  "With this Series B financing, we have raised the necessary funds to build on the pioneering research and foundational intellectual property of our scientific founders for human cell reprogramming and to enable the commercialization of our pharmaceutical grade iPSC technology."

About OVP Venture Partners
For 26 years, OVP Venture Partners has led the drive into new, high-growth technology markets in the Pacific Northwest.  OVP makes early stage investments in cleantech, digital biology and information technology.  The firms' record of 52 liquidity events – including 22 IPOs – leads the region.  OVP has over $750 million in capital under management and is currently investing its seventh fund.  The firm has offices in Seattle, WA and Portland, OR.  More information on the partnership is available at www.ovp.com.

About Fate Therapeutics, Inc.
Fate Therapeutics is interrogating adult stem cell biology and applying induced pluripotent stem cell (iPSC) technology to develop Stem Cell Modulators (SCMs), small molecule or biologic compounds that guide cell fate for therapeutic purposes.  Fate's approach has broad therapeutic potential in areas such as regenerative medicine, hematological diseases, metastatic cancer, traumatic injury and degenerative diseases.  The Company is currently conducting a Phase 1b clinical trial of FT1050, a small molecule SCM designed to increase hematopoietic stem cell number and function in dual umbilical cord blood transplant recipients with hematologic malignancies.  In addition, Fate Therapeutics and Stemgent have formed an alliance - CATALYST - a collaborative program to provide its members with first access to the most advanced iPSC technologies for drug discovery and development.  Fate Therapeutics is headquartered in La Jolla, CA.   For more information, please visit www.fatetherapeutics.com.


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Fate Therapeutics Closes $30 Million Series B Financing - Earthtimes

Posted: 16 Nov 2009 05:02 AM PST

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IsoRay, Inc. Reports First Quarter Results - Genetic Engineering News

Posted: 16 Nov 2009 04:26 AM PST

Nov 16 2009, 7:30 AM EST

IsoRay, Inc. Reports First Quarter Results

News source: Business Wire

IsoRay Inc. (AMEX:ISR) a medical isotope company focusing on the treatment of prostate, lung, head and neck and other malignant disease through the use of its proprietary radioisotope technology, announced its financial results for the first quarter of fiscal year 2010, ended September 30, 2009.

Sales revenue for the quarter decreased by 9% to approximately $1,379,087 as compared to approximately $1,519,582 in the first quarter of fiscal 2009. However, 50 medical centers ordered the Company's Proxcelan™ seeds in the first quarter of fiscal 2010 compared to the 47 centers that ordered in the first quarter of fiscal 2009. Management believes that the decline in sales revenue is primarily attributable to a lower average invoice price due to the change in the seed loading configurations being ordered by our current customers in comparison to the first quarter of FY2009. In addition, as physicians have become more comfortable with the increased energy of Cs-131 seeds, fewer seeds are being used.

Gross margin for the quarter increased by 208% to approximately $218,998 as compared to approximately $71,146 in the first quarter of fiscal 2009.

Basic and diluted loss per share for the quarter decreased by 50% to approximately $ (.04) per share as compared to approximately $ (.08) per share in the first quarter of fiscal 2009.

The Company's net loss decreased 49% from approximately $1,793,596 in the quarter ended September 30, 2008 to $906,708 in the quarter ended September 30, 2009.

The Company reduced its cash burn this quarter by 48% to approximately $515,597 as compared to approximately $989,015 in the first quarter of fiscal 2009. The Company had cash and short-term investments of approximately $4,029,087 as of September 30, 2009. Management believes that this cash position combined with our reduced monthly cash requirements can be used to support all of the current initiatives.

During the first quarter of FY2010, IsoRay commenced shipping seeds for use in other disease sites including lung, head and neck, and ocular melanomas, supporting the expansion of our total body brachytherapy isotope.

Dwight Babcock, IsoRay Chairman and CEO, commented "There is a unique opportunity for Cesium-131 with its short half life and energy level to become the isotope of choice for brachytherapy applications throughout the entire body. We are aggressively expanding the use of Cesium-131 throughout the body with our physician partners and demonstrating that Cs-131 can be effectively used as primary and adjunct treatment for many cancers. It is our expectation to continue to gain market share in the prostate market as well as expand into all other areas of the body with a total isotope solution. We already see our strategic plan gaining momentum and expect more facilities to adopt Cs-131 for other tumor locations."

About IsoRay

IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc., is the sole producer of the Cesium-131 brachytherapy seed.

The Cesium-131 seed offers a significantly shorter radiation half-life than the two other isotopes commonly used for brachytherapy, which results in a substantially faster delivery of therapeutic radiation, a theoretically improved radiation delivery against aggressively replicating cancer(a), and the potential for a reduced longevity of common brachytherapy side effects(b).

Cesium-131 is currently used in the treatment of prostate cancer(c) and ocular melanoma(d), among other cancerous conditions.

IsoRay is based in Richland, Washington. More information is available about IsoRay at www.isoray.com.

(a) Armpilia CI, Dale RG, Coles IP, et al. The Determination of Radiobiologically Optimized Half-lives for Radionuclides Used in Permanent Brachytherapy Implants. International Journal of Radiation Oncology, Biology, and Physics 2003;55(2):378-385.

(b) DeFoe SG, Beriwal S, Smith R, Benoit R. Is there decreased duration of acute urinary and bowel symptoms after prostate brachytherapy with cesium 131 isotope? International Journal of Radiation Oncology, Biology, and Physics 2008;72(S1):S317.

(c) Bice WS, Prestidge BR, Kurtzman SM, Beriwal S, Moran BJ, Patel RR, Rivard, MJ. Recommendations for permanent prostate brachytherapy with (131)Cs: a consensus report from the cesium advisory group. Brachytherapy 2008;7(4):290-6.

(d) Melhus CS, Rivard MJ. COMS eye plaque brachytherapy dosimetry simulations for 103Pd, 125I, and 131Cs. Medical Physics 2008;35(7):3364-71.

Safe Harbor Statement

Statements in this news release about IsoRay's future expectations, including: the advantages of our Cesium-131 seed, whether cash on hand will be sufficient to fund planned operations throughout FY2010, whether reductions in the Company's burn rate will continue, whether physicians and facilities will adopt Cs-131 for use for non-prostate cancers, future demand for IsoRay's existing and planned products, IsoRay's manufacturing needs and capabilities, whether IsoRay will continue to be able to reduce operating costs and increase revenue, whether IsoRay will be able to expand its base beyond prostate cancer, whether IsoRay's Cesium-131 seed will be used to treat additional cancers and malignant disease, and all other statements in this release, other than historical facts, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 ("PSLRA"). This statement is included for the express purpose of availing IsoRay, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as physician acceptance, training and use of IsoRay's products, changing levels of demand for IsoRay's current and proposed future products, success of future research and development activities, IsoRay's ability to successfully manufacture, market and sell its products, IsoRay's ability to manufacture its products in sufficient quantities to meet demand within required delivery time periods while meeting its quality control standards, IsoRay's ability to enforce its intellectual property rights, changes in reimbursement rates, changes in laws and regulations applicable to our product both in the United States and internationally, whether later studies and protocols are completed and support the conclusions of the initial studies, patient results achieved when Cesium-131 is used for the treatment of cancers and malignant diseases beyond prostate cancer, successful completion of future research and development activities, increases in expenses or other items affecting the Company's burn rate, and other risks detailed from time to time in IsoRay's reports filed with the SEC.

IsoRay, Inc. and Subsidiaries

Consolidated Statements of Operations

(Unaudited)

 
 
 

Three months ended

September 30,

2009

 

2008

 
Product sales $ 1,379,087 $ 1,519,582
Cost of product sales 1,160,089 1,448,436
 
Gross margin (loss) 218,998 71,146
 
Operating expenses:
Research and development expenses 68,882 218,550
Sales and marketing expenses 442,899 730,774
General and administrative expenses 602,431 780,157
 
Total operating expenses 1,114,212 1,729,481
 
Operating loss (895,214 ) (1,658,335 )
 
Non-operating income (expense):
Interest income 5,867 44,786

Gain (loss) on fair value of short-term investments

(159,200 )
Financing and interest expense (17,361 ) (20,847 )
 

Non-operating income (expense), net

(11,494 ) (135,261 )
 
Net loss $ (906,708 ) $ (1,793,596 )
 
Basic and diluted loss per share $ (0.04 ) $ (0.08 )
 

Weighted average shares used in computing net loss per share:

Basic and diluted 22,942,088 22,942,088

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