Pacira Pharmaceuticals, Inc. Reports Third Quarter 2011 Financial Results

October 31st, 2011 The News Desk

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Company Provides Update on FDA Approval of EXPAREL™ and Commercial Strategy

PARSIPPANY, N.J., Oct. 31, 2011 (CRWENEWSWIRE) — Pacira Pharmaceuticals, Inc. (Nasdaq:PCRX), an emerging specialty pharmaceutical company, today announced financial results for the third quarter ended September 30, 2011 and provided an update on the U.S. Food and Drug Administration’s (FDA) approval of EXPAREL™ (bupivacaine liposome injectable suspension) and the commercial strategy to support the product launch.

“With the broad postsurgical pain management label granted by the FDA, we are well positioned to execute our commercial strategy for EXPAREL,” said Dave Stack, president and chief executive officer of Pacira Pharmaceuticals, Inc. “Over the past several months, our entire organization has diligently focused on completing the pre-commercial activities necessary to prepare EXPAREL for launch. During this time, we have strengthened our relationships with clinicians and hospitals, presented data demonstrating the efficacy, safety and utility of EXPAREL and completed retrospective health outcomes studies highlighting the economic benefits of reducing opioid use in postsurgical pain management regimens. With these accomplishments as a platform, we believe we are on track for a successful hospital launch of EXPAREL in January 2012, focused on abdominal soft tissue surgeries typically performed by colorectal surgeons, general surgeons and OB/GYNs.”

EXPAREL Commercial Strategy

The company has previously announced its intention to launch EXPAREL into the broad hospital market in early 2012. By the time of launch, Pacira expects to have achieved the following:

* Final analysis of its retrospective health outcomes research studies, which demonstrate that in certain patient populations, opioid-based pain management often leads to patient care and economic challenges. The first of these data sets will be presented at the American Society of Health-System Pharmacists (ASHP) annual meeting in December in New Orleans.
* Initiated patient enrollment for its prospective health outcomes clinical study programs—conducted in partnership with its integrated health system customers—to evaluate the benefits of incorporating EXPAREL into the postsurgical pain management protocols in customer hospitals.
* Hired its 63-person sales force through its agreement with Quintiles who will cover more than 81 percent of the target market, which includes abdominal soft tissue surgeries, plastic surgeries such as breast augmentation and abdominoplasty and elastomeric pump replacement initiatives. Pacira recently hired regional sales directors who will oversee the hiring and training of these representatives, as well as work with the commercial team to target key hospital surgical customers for rapid formulary adoption.
* Developed key educational initiatives, such as center of excellence programs, preceptorship programs and web-based training focused on plastic surgery and elastomeric pump replacement audiences.

“Based upon our January launch timeline, we are moving forward with our strategy to build out a sales team that we believe can cover more than 81 percent of the hospital soft tissue surgery market,” continued Mr. Stack. “This team will also be focused on assisting our commercial team with accelerating the formulary process at key hospitals and gaining momentum within the plastic surgery market, where there are lower formulary approval requirements. Additionally, we expect to maintain a high level of activity with new peer-reviewed data publications and presentations at key medical meetings, which we believe will help further support an accelerated formulary approval strategy. We are excited about the interest and support for EXPAREL to date, and with our recent FDA approval we believe we are in a strong position to bring a new, much-needed postsurgical pain management therapeutic to the market.”

Recent Developments

* Published our bunionectomy data in Advances in Therapy and a review article in Pain Management. In October 2011, Pacira published an article in the peer-reviewed journal Pain Management evaluating the use of DepoFoam(R) in the treatment of postsurgical pain.
* Presented two podium presentations at the American College of Surgeons (ACS) 97th Annual Clinical Congress. In October 2011, Pacira presented new data introducing the potential for pharmacoeconomic benefits with EXPAREL at ACS in San Francisco. In addition, a second podium presentation highlighting a meta-analysis of the pain and opioid reduction observed across several clinical trials comparing EXPAREL to bupivacaine HCl was presented.
* Presented two posters at the 2011 Annual Meeting of the American College of Clinical Pharmacy (ACCP). In October 2011, Pacira presented new comparative data highlighting the pain control and opioid reduction observed in clinical trials of EXPAREL compared with bupivacaine HCl, as well as pharmacokinetic data at ACCP in Pittsburgh.
* Presented two posters at the 2011 Annual Meeting of the American Society of Anesthesiologists (ASA). In October 2011, Pacira also presented two similar posters at ASA in Chicago, which focused on the pharmacokinetics and reduction in opioid-related adverse events observed in patients treated with EXPAREL.
* Presented at the Annual Scientific Assembly of the American Society of Plastic Surgeons (ASPS). In September 2011, EXPAREL was featured in the “Hot Topics in Plastic Surgery” panel at ASPS in Denver. In addition, new data demonstrating the long-term safety profile of EXPAREL following breast augmentation using silicone implants were presented during an oral session at ASPS.
* Expanded commercial team infrastructure. In August 2011, Pacira announced that it had entered into agreements with Quintiles Commercial US, Inc. (Quintiles) and Integrated Commercialization Services, Inc. (ICS) to support the anticipated launch of EXPAREL.
* Presented at the 38th Annual Meeting & Exposition of the Controlled Release Society (CRS). In August 2011, Pacira presented new preclinical data evaluating the safety of DepoFoam, the Pacira proprietary, extended-release drug delivery technology, during two podium sessions at CRS in National Harbor, Md.

Financial Highlights

* Net loss for the third quarter ended September 30, 2011 was $9.5 million, or $0.55 per share (based on 17.2 million weighted average shares outstanding), compared with $7.9 million, or $13.77 per share, for the quarter ended September 30, 2010 (based on 0.6 million weighted average shares outstanding). The difference in the number of weighted average shares outstanding primarily resulted from the Pacira initial public offering (IPO) in February 2011, as well as the conversion of all preferred stock and the principal and accrued interest on certain notes into common stock upon closing of the IPO.
* Total revenues for the quarter ended September 30, 2011 were $4.0 million compared with $4.5 million for the third quarter of 2010. The decrease was primarily attributable to a $1.1 million decline in supply revenue which reflects fewer lot sales to Pacira’s commercial partners. This was offset by a $0.6 million increase in collaborative licensing and development revenue which was principally driven by activities performed under the license agreement Pacira has with Novo Nordisk that was executed in the first quarter of 2011.
* Total operating expenses for the quarter ended September 30, 2011 were $12.7 million compared with $11.0 million for the same period of 2010. The $1.7 million increase was primarily attributable to expenses related to pre-commercialization activities performed in anticipation of the launch of EXPAREL.
* As of September 30, 2011, Pacira had unrestricted cash, cash equivalents and short term investments of $37.1 million compared with $26.1 million on December 31, 2010.
* Cash used in operating activities and for the purchase of fixed assets used in investing activities (”cash burn”) was approximately $27 million for the nine months ended September 30, 2011.

Full Year 2011 Financial Guidance

* Pacira is reiterating its revenue expectations for 2011 and currently expects to achieve revenue in the range of $14 to $16 million for the full-year ending December 31, 2011. This revenue expectation excludes the impact of potential sales of EXPAREL.
* Pacira is also reiterating that its expectation for cash burn for the fourth quarter of 2011 is approximately $15 million. This cash burn expectation includes a $2 million development milestone due from Novo Nordisk A/S under the agreement announced in January 2011. As a result, Pacira expects to exit 2011 with approximately $22 million in unrestricted cash, cash equivalents and short-term investments.

Upcoming Activities

Pacira expects to present at the following investor conferences:

* 2011 Brean Murray, Carret & Co. Life Sciences Summit, November 14, in New York
* 23rd Annual Piper Jaffray Healthcare Conference, November 29-30, in New York

Pacira expects to have a presence at the following medical meetings:

* American College of Toxicology (ACT), November 6-9, in New York
* American Society of Health-System Pharmacists (ASHP), December 4-8, in New Orleans
* Postgraduate Assembly in Anesthesiology (PGA), New York State Society of Anesthesiologists (NYSSA), December 9-13, in New York
* New York School of Regional Anesthesia (NYSORA), December 17-18, in New York

Today’s Conference Call and Webcast Reminder

The Pacira management team will host a conference call discussing the company’s third quarter financial results, recent developments and 2011 financial guidance today at 9 a.m. (ET). The call can be accessed by dialing 1-866-831-6272 (domestic) or 1-617-213-8859 (international) five minutes prior to the start of the call and providing the passcode 24414196. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-888-286-8010 (domestic) or 1-617-801-6888 (international), providing the passcode 74599996. The replay of the call will be available for two weeks from the date of the live call.

The live, listen-only webcast of the conference call can be accessed by visiting the investors section of the Pacira’s website at www.pacira.com. A replay of the webcast will be archived on the company’s website for two weeks following the call.

About EXPAREL™

EXPAREL is an innovative product that combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. It represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting in the same fashion as current local anesthetics, which provide a relatively short duration of efficacy. By utilizing the DepoFoam platform, EXPAREL delivers bupivacaine for an extended period of time, providing analgesia with reduced opioid requirements for up to 72 hours. Additional information is available at www.EXPAREL.com.

Important Safety Information

The safety of EXPAREL has been evaluated in 21 clinical trials, which include over 1300 subjects in the safety database. EXPAREL administered locally into the surgical site was evaluated in 10 randomized, double-blind, clinical studies involving 823 patients undergoing various surgical procedures. Patients were administered a dose ranging from 66 mg to 532 mg of EXPAREL. EXPAREL is contraindicated in obstetrical paracervical block anesthesia. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. In these studies, the most common adverse reactions (incidence >10%) following EXPAREL administration were nausea, constipation, and vomiting.

Please see the full Prescribing Information for more details available at www.EXPAREL.com

About Pacira

Pacira Pharmaceuticals, Inc. is an emerging specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients. The company’s current emphasis is the development of non-opioid products for postsurgical pain control, and its lead product, EXPAREL (bupivacaine liposome injectable suspension), was approved for administration into the surgical site to produce postsurgical analgesia by the U.S. Food and Drug Administration in October 2011. EXPAREL and two other commercially available products utilize the Pacira proprietary product delivery technology DepoFoam(R), a unique platform that encapsulates drugs without altering their molecular structure and then releases them over a desired period of time. Additional information about Pacira is available at www.pacira.com.

Forward Looking Statements

Any statements in this press release about our future expectations, plans and prospects, including statements about EXPAREL’s potential, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: our plans to develop and commercialize EXPAREL; the success and timing of our commercial launch of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and our ability to serve those markets; our commercialization and marketing capabilities; and other factors discussed in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2010, and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Source: Pacira Pharmaceuticals, Inc.

Contacts:

Company Contact:
Pacira Pharmaceuticals, Inc.
James S. Scibetta, 973-254-3560

or

Investor Contact:
Pure Communications Inc.
Jennifer Beugelmans, 646-596-7473

 

Pacira Pharmaceuticals, Inc.

Consolidated Statement of Operations

(unaudited)

(in thousands, except share and per share amounts)

Three Months Ended September 30,

Nine Months Ended September 30,

2011

2010

2011

2010

Revenues:

Supply revenue

$ 1,682

$ 2,744

$ 4,868

$ 7,127

Royalties

922

1,023

2,743

2,693

Collaborative licensing and development revenue

1,352

765

3,845

2,551

Total revenues

3,956

4,532

11,456

12,371

Operating expenses:

Cost of revenues

3,357

3,573

10,138

10,168

Research and development

4,344

5,716

12,237

14,954

Selling, general and administrative

4,988

1,694

13,465

3,948

Total operating expenses

12,689

10,983

35,840

29,070

Loss from operations

(8,733)

(6,451)

(24,384)

(16,699)

Other (expense) income:

Interest income

46

39

111

112

Interest expense

(910)

(1,077)

(4,068)

(2,577)

Royalty interest obligation

116

(444)

235

(1,048)

Other, net

(27)

33

61

107

Total other expense, net

(775)

(1,449)

(3,661)

(3,406)

Net loss

$ (9,508)

$ (7,900)

$ (28,045)

$ (20,105)

Basic and diluted net loss per common share

$ (0.55)

$ (13.77)

$ (1.89)

$ (35.02)

Weighted average common shares outstanding - basic and diluted

17,230,826

573,521

14,826,054

574,112




Pacira Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(unaudited)

(in thousands)

September 30,

December 31,

2011

2010

Assets

Cash and cash equivalents and short-term investments

$ 37,068

$ 26,133

Restricted cash

1,687

1,314

Other current assets

4,645

3,608

Fixed assets, net

25,825

23,950

Intangibles and other assets, net

8,384

11,557

Total assets

$ 77,609

$ 66,562

Liabilities and stockholders’ equity (deficit)

Current liabilities

$ 17,829

$ 16,322

Related party debt, including accrued interest

-

49,795

Long-term debt and royalty interest obligation

22,445

24,865

Other long-term liabilities

23,460

23,963

Stockholders’ equity (deficit)

13,875

(48,383)

Total liabilities and stockholders’ equity

$ 77,609

$ 66,562

 

 

 

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THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!

Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. CRWENewswire.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold CRWENewswire.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://crwenewswire.com/disclaimer). Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings Inc. (CRWE.OB) is a media-advertisement and newswire company. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period.

 
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Seven Arts Entertainment Announces Primary Earnings per Share of $.77 for Fiscal Year Ended June 30, 2011

October 31st, 2011 The News Desk

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LOS ANGELES, CA–(CRWENEWSWIRE -10/31/11) - Seven Arts Entertainment Inc. (NASDAQ:SAPX) (”Seven Arts” or the “Company”) announced today the results of operations of its NASDAQ listing predecessor, Seven Arts Pictures plc (”PLC”), for the fiscal year ended June 30, 2011. PLC reported revenue of $3,328,000 and net income of $1,462,000, representing $0.77 of basic and diluted earnings per share.

These results compare to the results of operations for the fiscal year ended June 30, 2010, in which PLC reported revenue of $6,417,000 and a net loss of $476,000, which was a result of profit before interest and taxes plus other income from debt settlement, offset by net interest expense of approximately $1,706,000.

In the reported fiscal year, PLC recognized net cancellation of indebtedness revenue of $4,459,000 reflecting its continued efforts to reduce indebtedness and increase net shareholder equity. As reported in prior fiscal years, such cancellation of indebtedness income reflects adjustments to debtors’ claims on future film revenues and in management’s view represents continuing revenue and profits from core operations.

Peter Hoffman, Chief Executive Officer of Seven Arts, stated, “We are pleased our listing predecessor achieved net income of $1,462,000 and basic and diluted earnings per share of $0.77 in the last fiscal year. We are particularly pleased with the increases in our net shareholders’ equity from $2,200,000 as of June 30, 2010 to $7,958,000 as of June 30, 2011. This increase does not reflect the further, substantial reduction of debt and increase in net stockholders equity since the end of the fiscal year, as set forth in our letter to stockholders to be released this week.

“The independent film industry has experienced many challenges in the last fiscal year, which led to changes in our expected revenue model. Seven Arts reduced production during the fiscal year ended June 30, 2011 as it completed new sources of financing. We currently believe that Seven Arts is poised for success in the current fiscal year and beyond.

“PLC successfully completed the transfer of NASDAQ listing to the Company effective August 31, 2011. The Company is now a fully reporting United States issuer and will in the future report its results of operation under United States Generally Accepted Accounting Principles (”US GAAP”). Application of US GAAP to our listing predecessor’s reported results of operation will not result in any material changes to PLC’s reported results of operation under International Financial Reporting Standards. We expect Seven Arts’ first quarterly report will be for the fiscal quarter ended September 30, 2011.”

 

Selected Financial Data
                    (in $ 000's, except per share data)

                                           Fiscal      Fiscal      Fiscal
                                           Year        Year        Year
                                           Ended       Ended       Ended
                                          June 30,    June 30,    June 30,
Summary Profit and Loss Data                2011        2010        2009
                                         ----------  ----------  ----------

Total Revenue                            $    3,328  $    6,417  $   10,222

Cost of Sales                            $   (3,448) $   (2,399) $   (4,633)

Gross Profit                             $     (120) $    4,018  $    5,569

Operating expenses                       $   (2,120) $   (2,939) $   (4,125)

Income before interest and taxes         $   (2,240) $    1,080  $    1,444

Other Income                             $    4,459  $      150  $    5,602

Net interest (expense)                   $     (758) $   (1,706) $   (2,308)

Income/(Loss) Before Taxes               $    1,461  $     (476) $    4,737

Provision for Taxes                      $        0  $        0  $        0

Net Income/(Loss)                        $    1,461  $     (476) $    4,737

Weighted Average Common Shares used in
 Earnings/(loss) per share calculation
Basic (in 000's)                              1,889       1,403       6,051
Diluted (in 000's)                            1,889       1,403       8,147

Earnings /(loss) Per Share - Basic       $     0.77  $    (0.35) $     0.78
Earnings/ (loss) Per Share - Diluted     $     0.77  $    (0.35) $     0.58

                                           June 30,    June 30,    June 30,
Balance Sheet Data                           2011        2010        2009

Total Assets                             $    27,946 $    28,625 $    27,387

Total Loans Payable                      $    12,646 $    18,301 $    17,828

Shareholders' Equity                     $     7,958 $     2,200 $     1,717

 

About Seven Arts:

Seven Arts Pictures PLC was founded in 2002 as an independent motion picture production and distribution company engaged in the development, acquisition, financing, production, and licensing of theatrical motion pictures for exhibition in domestic (i.e., the United States and Canada) and foreign theatrical markets, and for subsequent worldwide release in other forms of media, including home video and pay and free television.

Cautionary Information Regarding Forward-Looking Statements:
Forward-looking statements contained in this press release are made under the Safe Harbor Provision of the Private Securities Litigation Reform Act of 1995. Any such statements are subject to risks and uncertainties that could cause actual results to differ materially from the anticipated.

Source: Seven Arts Entertainment Inc.

Contact:

Porter, LeVay & Rose, Inc.:
Michael Porter
Seven Penn Plaza
Suite 810
New York, NY 10001
212-564-4700
Mike@prlninvest.com

 

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CytRx Announces Favorable Initial Results from its Ongoing Phase 1b/2 Clinical Trial in Patients with Soft Tissue Sarcomas

October 31st, 2011 The News Desk

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One patient exhibits a partial tumor response (greater than 30% tumor shrinkage) and four patients have stable disease following four cycles of INNO-206 administration

INNO-206 international Phase 2b clinical trial in advanced soft tissue sarcomas expected to begin in December 2011

LOS ANGELES–(CRWENEWSWIRE) — CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company specializing in oncology, today announced favorable response and safety indications from a group of patients with advanced solid tumors (principally soft tissue sarcomas) in the Company’s ongoing Phase 1b/2 clinical trial with INNO-206, its tumor-targeting conjugate of the commonly used chemotherapeutic agent doxorubicin. Patients in this portion of the Phase 1b/2 clinical trial received three different dose levels of INNO-206 to determine its maximum tolerated dose.

In the initial Phase 1b portion of the clinical trial, 12 patients, primarily with advanced soft tissue sarcomas, have received one or more administrations of treatment with INNO-206 in three-week cycles. The Company determined a maximum tolerated dose of INNO-206 that delivers a doxorubicin equivalent of 3½ times the standard doxorubicin dose administered to sarcoma patients. CytRx is currently enrolling additional patients who will be treated at that dose to gather further response data in parallel with the planned international Phase 2b clinical trial scheduled to start this quarter.

Of five patients who have completed four cycles with INNO-206 at the maximum tolerated dose, one patient has exhibited a partial tumor response (greater than 30% tumor shrinkage) and four patients have stable disease. Unexpectedly, a large, painful oral sarcoma that caused difficulty eating in one patient was greatly reduced following a single INNO-206 treatment. Common side effects reported to date from the Phase 1b/2 trial include low neutrophil (white blood cell) and platelet counts, minor mouth ulcers and mild nausea, which are expected side effects of doxorubicin.

“Initial data of response and safety from INNO-206 in this portion of the Phase 1b/2 trial are very important,” said CytRx President and CEO Steven A. Kriegsman. “Although these initial results are from a limited number of patients, the individuals treated were very advanced in their disease and had previously received multiple different chemotherapy agents, including doxorubicin, so we are pleasantly surprised to observe stable disease, much less tumor shrinkage, in these cancer patients. We believe these early indications bode well for the potential success of our international Phase 2b clinical trial in patients who have advanced disease but were not previously administered chemotherapy.”

“The response from this small group of patients treated with INNO-206 is encouraging and we look forward to sharing the full, final data from the Phase 1b/2 clinical trial in a presentation at ASCO 2012,” said Sant P. Chawla, M.D., F.R.A.C.P. The Phase 1b/2 clinical trial is being conducted at the Sarcoma Oncology Center in Santa Monica, Calif. under the direction of Dr. Chawla, a world-renowned expert in soft tissue sarcoma treatment who has evaluated most chemotherapies being tested in this indication.

In September 2011, CytRx announced completion of the maximum tolerated dose portion of the Phase 1b/2 trial, which included 12 patients. The patients from the early portion of the trial were evaluated for tumor response after four cycles of INNO-206. The Company also announced plans to add 12 patients to the Phase 1b/2 trial to receive INNO-206 at the maximum tolerated dose, and six of those additional patients have already been enrolled.

About INNO-206

INNO-206 is a novel conjugate of doxorubicin that binds covalently to albumin, the most abundant protein in blood plasma, and is circulated throughout the body. Doxorubicin is a standard chemotherapeutic treatment for a variety of cancers and is used either alone or in combination with other chemotherapy agents. INNO-206 is designed with a linker that releases doxorubicin in the low pH environment of tumors, concentrating the chemotherapeutic agent where it preferentially damages the tumor while minimizing the effect on healthy tissues. This conjugate formulation has the potential to safely deliver greater amounts of doxorubicin directly to the tumor compared with standard doxorubicin treatment, which could lead to improved efficacy.

CytRx holds the exclusive worldwide rights to INNO-206 — a platform technology designed to reduce adverse events by controlling drug release and preferentially targeting tumors. In addition to doxorubicin, several other chemotherapy agents have been attached to the linker used for INNO-206, including paclitaxel, cisplatin and methotrexate, and may be incorporated into future clinical development by the Company.

About Advanced Soft Tissue Sarcomas

Patients with advanced soft tissue sarcomas who can no longer be treated with surgery have a poor prognosis and limited options. Progression-free survival for patients with advanced soft tissue sarcomas is around six to seven months, and median overall survival is approximately 18 months with less than one-third of these patients living past three years. Combinations of the chemotherapy drugs ifosfamide and doxorubicin appear to offer the highest response rates and longest time to progression in these patients; however, these regimens have not significantly improved survival and are quite toxic.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development oncology company engaged in the development of high-value human therapeutics. The CytRx oncology pipeline includes three programs in clinical development for cancer indications: INNO-206, tamibarotene and bafetinib. With its tumor-targeted doxorubicin conjugate INNO-206, CytRx plans to initiate a Phase 2b clinical trial as a treatment for soft tissue sarcomas in 2011, following its Phase 1b/2 clinical trial. The Company is evaluating bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL) and the PROACT Phase 2 clinical trial in advanced prostate cancer. CytRx’s pipeline also includes tamibarotene, which it is testing in a double-blind, placebo-controlled Phase 2 clinical trial in patients with non-small-cell lung cancer, and which is in a registration clinical trial as a treatment for acute promyelocytic leukemia (APL). For more information on the Company, visit http://www.cytrx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks or uncertainties related to the outcome, timing and results of CytRx’s Phase 1b/2 clinical trial for INNO-206 in patients with advanced solid tumors or planned Phase 2b clinical trial for INNO-206 as a treatment for soft tissue sarcomas, the risk that INNO-206 might not show greater efficacy than doxorubicin notwithstanding the administration of higher doses than the standard of care, the risk that additional longer-term dosing of INNO-206 might cause adverse events not seen to date in CytRx’s Phase 1b/2 trial, the risk that additional patients receiving the maximum tolerated dose of INNO-206 in the Phase 1b/2 trial might not respond as well as the initial patients, uncertainties regarding whether INNO-206 effectively targets doxorubicin to tumors, uncertainties regarding regulatory approvals for current and future clinical testing of INNO-206 and the scope of the clinical testing that may eventually be required by regulatory authorities for INNO-206, the significant time and expense that will be incurred in developing any of the potential commercial applications for INNO-206, including for soft tissue sarcomas, risks related to CytRx’s ability to manufacture its drug candidates, including INNO-206, in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx’s need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including any future clinical development of INNO-206, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx’s most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: CytRx Corporation

Contact:

Legend Securities, Inc.
Investor Relations
Thomas Wagner, 800-385-5790 x152
718-233-2600 x152
twagner@legendsecuritiesinc.com

 

 

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(ARWR, RGEN, MJGCF, HMNF) Featured Stock by pennyotcstock.com

October 31st, 2011 The News Desk

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Arrowhead Research Corp. (Nasdaq:ARWR) has appointed Bruce Given, M.D. to the position of Chief Operating Officer of the Company effective October 26, 2011. Since February 1, 2010, Dr. Given has served as Chief Executive Officer of Leonardo Biosystems, Inc., a company in which Arrowhead maintains a minority equity interest, and he also has served as a director of Calando Pharmaceuticals, Inc., a subsidiary of Arrowhead, since October 1, 2009

Arrowhead Research Corporation, a development stage nanomedicine company, through its subsidiaries, develops therapeutic products at the interface of biology and nanoengineering to cure disease and improve human health.

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Repligen Corporation (Nasdaq:RGEN) reported results for the second quarter of fiscal year 2012, ended September 30, 2011. Total revenue for the second quarter was $8,631,000 compared to total revenue of $7,307,000 for the second quarter of fiscal year 2011, an increase of $1,324,000 or 18%. Bioprocessing product revenue for the second quarter was $5,742,000, the highest level recorded to date, compared to $4,416,000 for the second quarter of fiscal year 2011, an increase of 30%.

Repligen Corporation, a biopharmaceutical company, engages in the development and commercialization of therapies that deliver value to patients and clinicians in neurology, gastroenterology, and orphan diseases.

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http://pennyomega.com/img/mjgcf.jpg Majestic Gold Corp. (MJGCF.PK)

Gold is an essential element for our lives as it is not used only in the industry of jewelry, but also in other technological and medical fields. Its multifunctional nature is the reason why gold is considered to be more valuable than the rest of the metals.

Majestic Gold Corp. engages in the exploration and development of mineral properties in China. The company focuses on its gold project located in the prolific gold region of Song Jiagou in eastern Shandong Province. Majestic Gold Corp. is headquartered in Vancouver, Canada.

Majestic Gold Corp. (MJGCF.PK) has arranged a $10,000,000 loan to advance its Song Jiagou project in China. Nine million dollars ($9,000,000) from the proceeds from the loan will be used by the Company to in connection with its Song Jiagou project and the balance of one million dollars ($1,000,000) for general working capital purposes.

The loan will have a one year term and loan principal will be convertible at the option of the lender in whole or in part into common shares (”Shares”) of the Company until twelve months from the date of the loan advance at the price of $0.205 per Share. The loan will bear interest at the rate of 7.5% per annum, payable on maturity, and accrued and unpaid interest will be convertible at the option of the lender in whole or in part into shares of the Company until twelve months from the date of the loan advance at Market Price at the time of conversion.

The lender is at arm’s length from the Company and will not become an insider as a result of any conversion of principal and interest. All shares issued on any conversion of loan principal or interest will be subject to a four month hold period from the date of advance of loan proceeds. The loan is subject to acceptance by the TSX Venture Exchange.

As additional consideration for the loan, the Company has agreed to forward at least $9 million to Majestic Yantai Gold Ltd., a British Virgin Islands company owned 94% by the Company to be used to further advance its Song Jiagou project. The Borrower has also agreed to a 90 day period for reciprocal due diligence reviews and discussions for the possible further involvement of the Lender in the Song Jiagou project.

For more information, please visit their website: http://www.majesticgold.net

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HMN Financial Inc. (Nasdaq:HMNF) reported a net loss of $2.1 million for the third quarter of 2011, an improvement of $7.3 million, or 78.1%, compared to a net loss of $9.4 million for the third quarter of 2010. Net loss available to common shareholders was $2.5 million for the third quarter of 2011, an improvement of $7.3 million, or 74.4%, from the net loss available to common shareholders of $9.8 million for the third quarter of 2010. Diluted loss per common share for the third quarter of 2011 was $0.65, a decreased loss of $1.95, or 75.0%, from the diluted loss per common share of $2.60 for the third quarter of 2010.

HMN Financial, Inc. operates as the holding company for Home Federal Savings Bank that provides community banking services in Minnesota and Iowa. The company accepts deposits and originates or purchases loans.

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(CLNO, QLIK, CBOU, AXTI) Stock in Action by pennyotcstock.com

October 31st, 2011 The News Desk

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http://pennyomega.com/img/clno.jpg Cleantech Transit, Inc. (CLNO)

Pyrolysis is the thermal decomposition of biomass occurring in the absence of oxygen. It is the fundamental chemical reaction that is the precursor of both the combustion and gasification processes and occurs naturally in the first two seconds. The products of biomass pyrolysis include biochar, bio-oil and gases including methane, hydrogen, carbon monoxide, and carbon dioxide. Depending on the thermal environment and the final temperature, pyrolysis will yield mainly biochar at low temperatures, less than 450 0C, when the heating rate is quite slow, and mainly gases at high temperatures, greater than 800 0C, with rapid heating rates. At an intermediate temperature and under relatively high heating rates, the main product is bio-oil.

Cleantech Transit Inc. was founded to capitalize on technology advances and manufacturing opportunities in the growing clean energy public transportation sector. The Company has expanded its focus to invest directly in specific green projects. Recognizing the many economic and operational advances of converting wood waste into renewable sources of energy, Cleantech has selected to invest in Phoenix Energy (www.phoenixenergy.net). This project could benefit the Company’s manufacturing clients worldwide.

Cleantech Transit, Inc. (CLNO) is pleased to announce it has met its funding requirement to secure the Company’s ability to earn in 25% of the 500KW Merced Project.

The Company is in the final stages of closing its initial interest in the Merced Project and is currently working on completing the necessary documentation and expects closing the transaction soon. As previously announced Cleantech has the option to earn up to 40% of the Merced Project and the Company plans to continue to work towards increasing its interest in the Merced Project as they move ahead.

For more information about Cleantech Transit, Inc. visit its website www.cleantechtransitinc.com

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Qlik Technologies, Inc. (Nasdaq:QLIK) announced financial results for the three month period ended September 30, 2011. Total revenue for the third quarter of 2011 was $75.5 million, an increase of 50% from $50.3 million in the third quarter of 2010. License revenue was $45.5 million, an increase of 51% from $30.1 million in the third quarter of 2010. Maintenance revenue was $23.0 million, an increase of 54% from $15.0 million in the third quarter of 2010. Professional services revenue was $7.0 million, an increase of 35% from $5.2 million in the third quarter of 2010.

Qlik Technologies Inc. engages in the development, commercialization, and implementation of software products and related services that deliver data analysis and reporting solutions primarily in the Americas, and Europe.

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Caribou Coffee Company, Inc. (Nasdaq:CBOU) announced that it will release financial results for its third quarter after the market close on Tuesday, November 8, 2011. Management will host a conference call at 4:30 p.m. Eastern Time the same day as the earnings release.

Caribou Coffee Company, Inc. owns and operates coffeehouses. The company offers premium coffee and espresso-based beverages, as well as specialty teas, handcrafted beverages, foods, coffee lifestyle items, branded merchandise, and related products.

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AXT Inc. (Nasdaq:AXTI) reported financial results for the third quarter ended September 30, 2011. Revenue for the third quarter of 2011 was $28.3 million, down 5.7 percent from $30.0 million in the second quarter of 2011, and up 5.6 percent from $26.8 million in the third quarter of 2010. Total gallium arsenide (GaAs) substrate revenue was $18.7 million for the third quarter of 2011, compared with $18.0 million in the second quarter of 2011, and $19.2 million in the third quarter of 2010. Indium phosphide (InP) substrate revenue was $1.5 million for the third quarter of 2011, compared with $1.6 million in the second quarter of 2011, and $1.0 million in the third quarter of 2010. Germanium (Ge) substrate revenue was $3.0 million for the third quarter of 2011 compared with $2.7 million in the second quarter of 2011 and $2.3 million in the third quarter of 2010. Raw materials sales were $5.1 million for the third quarter of 2011, compared with $7.7 million in the second quarter of 2011 and $4.4 million in the third quarter of 2010.

AXT, Inc., together with its subsidiaries, designs, develops, manufactures, and distributes compound and single element semiconductor substrates for use in wireless communications, lighting display applications, fiber optic communications, and solar cell.

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