CYTR-CytRx Corporation-Small Cap Penny Stock. - Stock Market Forum, Penny Stocks, FOREX, NASDAQ, AMEX, NYSE, Live Chat

**greencat** · #1 06-08-2008, 12:36 PM

I have my eye on this one it may take off.

BUSINESS SUMMARY
CytRx Corporation, a biopharmaceutical research and development company, engages in developing human therapeutic products primarily based upon small molecule molecular chaperone co-induction technology. The company has completed a Phase IIa clinical trial of its small molecule product candidate, arimoclomol, for the treatment of amyotrophic lateral sclerosis or Lou Gehrig's disease. It intends to start a Phase IIb clinical trial as soon as the FDA provides clearance; and to commence a Phase II clinical trial of arimoclomol for the treatment of stroke damage repair and a Phase II clinical trial of iroxanadine for the treatment of diabetic foot ulcers. In addition, the company owns 49% of RXi Pharmaceuticals, which develops therapeutic products based upon ribonucleic acid interference technologies for the treatment of human diseases, including neurodegenerative diseases, cancer, type 2 diabetes, and obesity. The company was founded in 1985 and is headquartered in Los Angeles, California.

Shares Outstanding5: 90.77M
Float: 81.33M
% Held by Insiders1: 5.04%
% Held by Institutions1: 29.60%
Shares Short (as of 12-May-08)3: 6.58M
Short Ratio (as of 12-May-08)3: 11.6
Short % of Float (as of 12-May-08)3: 7.60%
Shares Short (prior month)3: 7.00M

Income Statement
Revenue (ttm): 8.08M
Revenue Per Share (ttm): 0.092
Qtrly Revenue Growth (yoy): 39.50%
Gross Profit (ttm): 7.46M
EBITDA (ttm): -26.68M
Net Income Avl to Common (ttm): -23.47M
Diluted EPS (ttm): -0.27
Qtrly Earnings Growth (yoy): N/A

Balance Sheet
Total Cash (mrq): 43.54M
Total Cash Per Share (mrq): 0.48
Total Debt (mrq): 0
Total Debt/Equity (mrq): N/A
Current Ratio (mrq): 3.729
Book Value Per Share (mrq): 0.368

Cash Flow Statement
Operating Cash Flow (ttm): -24.58M
Levered Free Cash Flow (ttm): -15.98M

**BadThad** · #2 06-09-2008, 04:23 PM

Ahhh...another biopharma....the PPS is sure down. They are on the edge of getting delisted with NASDAQ, prob for low PPS. On a technical basis, I think you're on to something. More DD is needed for a fundamental analysis. It may really break if they have something good in the pipes.

**paperchase** · #3 07-29-2009, 08:58 AM

CytRx's INNO-206 Demonstrates Statistically Significant Tumor Shrinkage in Animal Trial for Breast Cancer
8:30a ET July 13, 2009 (Business Wire)
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, today announced that its investigational cancer drug INNO-206 caused a dramatic destruction of implanted tumors in an experimental animal model of breast cancer, performing considerably better than the broadly used and generally effective chemotherapeutic drug doxorubicin. In addition to improved efficacy in this animal trial, INNO-206 was comparable in toxicity with doxorubicin based on animal body-weight loss.

CytRx has exclusive worldwide rights to INNO-206, a proprietary derivative of doxorubicin. The pro-drug INNO-206 is designed to allow controlled release of doxorubicin and to specifically target the delivery of drug to tumors throughout the body, which could prove more effective and less toxic in cancer patients than doxorubicin. INNO-206 has previously demonstrated safety and tolerability, and optimal dosing has been evaluated, in a Phase I clinical trial.

In the animal trial - conducted under the direction of INNO-206 inventor Felix Kratz, Ph.D., Department of Medical Oncology, Clinical Research, at the Tumor Biology Center in Freiburg, Germany - human breast tumor cells were implanted in mice with compromised immune systems to avoid tumor rejection. Seven to eight animals were randomly assigned into each of three experimental groups receiving intravenous injections with either a maximum tolerated dose of INNO-206, a maximum tolerated dose of doxorubicin, or a control solution lacking either compound. At the end of the experiment 43 days after implantation, tumors had increased in volume by an average of approximately 2.7-fold in the control group while tumor growth was marginally inhibited in the doxorubicin group; increasing in volume by approximately 1.9-fold in a result that did not reach statistical significance. By contrast, tumors in the group treated with INNO-206 shrank to approximately one-half their initial volume. The decrease in final tumor volume in INNO-206-treated animals was statistically significant (p<0.05) compared to that of either the control or doxorubicin-treated groups.

"We take pride in identifying and developing drugs that hold the promise of treating debilitating diseases that represent unmet medical needs, as well as have therapeutic and commercial potential in multiple disease indications," said Steven A. Kriegsman, CytRx President and CEO. "INNO-206 is one of several drug candidates in CytRx's asset portfolio that meets these criteria due to its apparent ability to target multiple tumor types, making it potentially efficacious in other cancers."

"We acquired INNO-206 because of our belief that its pro-drug design could improve the efficacy of doxorubicin, a classic chemotherapeutic agent that has proven effective and is commonly used in treating multiple types of cancer," said Joseph Rubinfeld, Ph.D., co-founder of Amgen, a world-renowned expert in cancer drug development and CytRx Chief Scientific Advisor. "If INNO-206 is better than doxorubicin in treating human breast cancer as it demonstrated in this animal breast cancer trial, then we believe that INNO-206 could be a multi-billion dollar drug."

About Breast Cancer

Breast cancer is the most common cancer among women in the U.S., with more than 192,000 new cases of invasive breast cancer expected to be diagnosed this year, according to American Cancer Society estimates. More than 40,000 deaths are expected to be attributed to breast cancer in the U.S. in 2009, making it the second leading cause of cancer death in U.S. women. The chance of a woman having invasive breast cancer some time during her life is about one in eight.

About INNO-206

INNO-206 is a prodrug of the commonly prescribed chemotherapeutic doxorubicin and was designed to reduce adverse events by controlling release and preferentially targeting the tumor. In a Phase 1 study, doses were administered at up to six times the standard dosing of doxorubicin without an increase in observed side effects over those historically seen with doxorubicin. The Company is evaluating options for a possible Phase 2 clinical trial.

**paperchase** · #4 07-29-2009, 08:59 AM

CytRx's INNO-206 Significantly Inhibits Pancreatic Cancer Growth in Animal Trials
8:30a ET July 20, 2009 (Business Wire)
--- Results Presented at the American Association for Cancer Research Annual Meeting -

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, today announced that treatment with its cancer drug candidate INNO-206 resulted in a statistically significant reduction in the average primary tumor size in an animal model of pancreatic cancer, outperforming the broadly used chemotherapeutic drug doxorubicin, as well as the current standard of care in pancreatic cancer treatment, gemcitabine.

Results from the trial, which was conducted under the direction of INNO-206 inventor Felix Kratz, Ph.D., Department of Medical Oncology, Clinical Research, at the Tumor Biology Center in Freiburg, Germany, were presented in a poster, "INNO-206 Shows Superior Efficacy Compared to Doxorubicin in an Orthotopic Pancreas Carcinoma Model," at the Annual Meeting of the American Association for Cancer Research on April 21, 2009.

"Few drugs show any benefit for patients suffering from this rapidly progressing and deadliest of cancers, and I am personally delighted that INNO-206 effectively treated tumors in these experimental animals," said Steven A. Kriegsman, CytRx President and CEO. "We now have further evidence that the putative targeting mechanism of INNO-206 could have significant therapeutic benefit in multiple types of cancer."

CytRx has exclusive worldwide rights to INNO-206, which is a proprietary derivative of doxorubicin. CytRx believes that INNO-206, which is a so-called pro-drug designed to control the release of doxorubicin and to target it specifically to tumors throughout the body, may prove to be more effective and less toxic in cancer patients than doxorubicin. Earlier this month, CytRx announced that INNO-206 caused a dramatic destruction of implanted tumors in an experimental animal model of breast cancer, performing considerably better than doxorubicin.

In the animal trial, human AsPC1 pancreatic cancer cells were implanted directly into the pancreas (orthotopic implantation) of 30 experimental mice that lacked a normal immune system that would otherwise reject these cells. This model accurately reflected the hallmarks of the human disease, such as early cancer cell invasion of the surrounding pancreatic tissue and tumor spread to the spleen, liver and peritoneum that surrounds the internal organs. Eighteen days after implantation, the experimental animals were randomized into three treatment groups. Each group received two cycles of weekly intravenous injections with the previously optimized dose of either doxorubicin or INNO-206, or a solution lacking either drug to serve as a control. Tumor growth was monitored continuously. Two weeks after therapy initiation, measurements were taken of the primary tumor volume and the spread of the tumor to the liver, spleen, stomach and peritoneum.

Treatment with CytRx's INNO-206 resulted in a statistically significant (p<0.005) three-fold reduction in the average primary tumor size, compared to the control. Treatment with doxorubicin showed only a 30% primary tumor reduction, which was not statistically significant - a response that was not surprising as pancreatic tumors are typically unresponsive to doxorubicin. In a parallel experiment, treatment with gemcitabine, the approved and most commonly prescribed drug for pancreatic cancer, resulted in activity comparable to doxorubicin, with an approximate 30% primary tumor volume reduction.

Although no statistically significant inhibition of tumor spread was demonstrated by either INNO-206 or gemcitabine, due to large variability between individual animals in the control, a substantial trend was observed in the INNO-206 group with an approximate 10-fold decrease in tumor spread to the liver and stomach. The toxicity associated with drug treatment was comparable among the treated groups, resulting in an average weight loss over the two treatment cycles of about 10% compared to the control group.

"It is truly exciting that in this animal trial our doxorubicin-derivative INNO-206, possibly due to its known tumor-targeting capabilities, inhibited growth in tumors that were not affected by doxorubicin itself," said CytRx's Chief Scientific Advisor Joseph Rubinfeld, Ph.D., co-founder of Amgen and a world-renowned expert in cancer drug development. "This raises the possibility that INNO-206 could have even broader applicability as a cancer treatment than highly prescribed doxorubicin. INNO-206 also demonstrated significantly better tumor reduction capabilities in this model than gemcitabine, the current clinical standard of pharmaceutical care in this cancer."

About Pancreatic Cancer

Pancreatic cancer, although a relatively rare form of cancer, is the fourth leading cause of cancer mortality in the U.S. with only a 20% one-year survival rate, according to the American Cancer Society. This year in the U.S., the American Cancer Society estimates approximately 42,000 new pancreatic cancer cases and more than 35,000 deaths due to this disease. One in 76 people is expected to develop pancreatic cancer sometime in their life.

About INNO-206

INNO-206 is a prodrug of the commonly prescribed chemotherapeutic doxorubicin and was designed to reduce adverse events by controlling release and preferentially targeting the tumor. In a Phase 1 study, doses were administered at up to six times the standard dosing of doxorubicin without an increase in observed side effects over those historically seen with doxorubicin. The Company is evaluating options for a possible Phase 2 clinical trial.

**paperchase** · #5 07-29-2009, 09:00 AM

CytRx's Tamibarotene Receives Positive Opinion from the Committee for Orphan Medicinal Products in the European Union for Treatment of APL
8:30a ET July 24, 2009 (Business Wire)
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, today announced that its lead drug candidate tamibarotene has received official notification from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) that a positive opinion was made regarding the application for orphan medicinal product for the treatment of acute promyelocytic leukemia (APL). The positive opinion of the COMP has now been forwarded to the EU commission for final approval and publication in the community register. This favorable opinion for tamibarotene in the European Union (EU) is in addition to the Orphan Drug Designation for APL and Fast Track Designation for the treatment of adult patients with relapsed or refractory APL following treatment with all-trans retinoic acid (ATRA) and arsenic trioxide granted by the U.S. Food and Drug Administration (FDA) in October 2007.

"We believe that the positive opinion by the COMP reflects the potential therapeutic value of tamibarotene as a treatment for European patients suffering from APL, especially for those who currently lack an effective third-line therapy for their disease. We consider this positive opinion important as it supports our ability to pursue marketing approval for tamibarotene in the EU in addition to our ongoing U.S. clinical program," said Steven A. Kriegsman, CytRx President and CEO.

CytRx Chief Scientific Officer Jack Barber, Ph.D., commented, "The granting of orphan medicinal product status for tamibarotene will provide us with an improved communications mechanism with the European Medicines Agency (EMEA) and other EU regulatory officials going forward as we pursue EU approval. Added interaction between the EMEA and CytRx during the regulatory process could assist us in obtaining marketing approval for tamibarotene for the treatment of APL in the EU."

The European Commission grants orphan medicinal product status to promote the innovation of drugs that are developed to treat, prevent or diagnose diseases or conditions that affect no more than five in 10,000 persons in the EU. With this designation, CytRx will have market exclusivity in the EU for 10 years in the event that tamibarotene receives marketing approval. The designation also provides for special benefits, including research support, eligibility for protocol assistance and possible exemptions or reductions in certain regulatory fees during development, or at the time of application for marketing approval.

About Acute Promyelocytic Leukemia

Acute promyelocytic leukemia (APL) is a subtype of acute myelogenous leukemia, a cancer of the blood and bone marrow. In APL, an abnormal accumulation of immature granulocytes called promyelocytes in the bone marrow results in a reduction in the production of normal red blood cells and platelets, resulting in anemia and thrombocytopenia. Either leukopenia (low white cell count) or leukocytosis (high white cell count) may be observed in the peripheral blood. Symptoms include fatigue, weakness, shortness of breath from anemia, easy bruising and bleeding from thrombocytopenia and coagulopathy, and fever and infection from lack of normal white blood cells.

About Tamibarotene

CytRx holds the North American and European rights to tamibarotene as a treatment for APL. Tamibarotene is an orally available, rationally designed, synthetic retinoid compound designed to potentially avoid toxic side effects by binding to its molecular target more selectively than all trans-retinoic acid (ATRA), the current first-line treatment for APL. The FDA has granted Orphan Drug Designation for APL and Fast Track Designation for the treatment of adult patients with relapsed or refractory APL following treatment with all-trans retinoic acid (ATRA) and arsenic trioxide. There are currently no third-line treatments for APL approved in the U.S. or Europe.

A Special Protocol Assessment (SPA) is in place with the FDA for a Phase 2 registration clinical trial, known as STAR-1, which is evaluating the efficacy and safety of tamibarotene as a third-line treatment for APL. The STAR-1 trial is ongoing and currently includes seven clinical sites in the U.S. CytRx believes that successful data from the STAR-1 trial and supporting studies, in conjunction with data from the Japanese clinical trials, will form the basis for a New Drug Application (NDA). CytRx recently reported that, of the 11 patients enrolled in the STAR-1 trial to date, 5 patients, or 45%, achieved a morphologic leukemia-free state, or MLFS. Of those, two patients have achieved durable complete response and one has achieved morphologic leukemia-free state, or MLFS, but withdrew from the trial to receive a bone marrow transplant before the durable complete response could be confirmed. One patient achieved a complete response, but did not maintain MLFS for the required 28 days to be considered a durable complete response. Another patient achieved a durable MLFS, but did not have the necessary increases in blood cells to be considered a durable complete response.

The efficacy of orally administered tamibarotene was demonstrated in two Phase 2 studies conducted in Japan in a total of 63 Japanese subjects with APL. The overall complete response rate in these subjects was 60%. In subjects experiencing their first relapse, the overall complete response rate was 81%. Tamibarotene is currently approved in Japan as a treatment for relapse APL.

CytRx also retains an option to expand its licenses for the use of tamibarotene in other fields in oncology, including multiple myeloma, myelodysplastic syndrome and certain solid tumors in the U.S., and multiple myeloma, myelodysplastic syndromes and solid tumors other than hepatocellular carcinoma in Europe. Tamibarotene also has showed statistically significant anti-tumor activity in animal trial for multiple myeloma, an incurable malignant tumor of the plasma cells of bone marrow.

**paperchase** · #6 07-29-2009, 09:00 AM

CytRx Announces $20 Million Registered Direct Offering
2:00p ET July 24, 2009 (Business Wire)
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, today announced that it has entered into definitive agreements with several institutional investors to purchase 15.3 million shares of common stock at $1.31 per share and warrants to purchase approximately 3.8 million shares of common stock at an exercise price of $1.70 per share. The registered direct offering will raise approximately $20.0 million from the sale of common stock and warrants, with net proceeds to CytRx of approximately $18.3 million after deduction of offering expenses.

The securities are being sold pursuant to the Company's effective shelf registration. Rodman & Renshaw, LLC, a wholly owned subsidiary of Rodman & Renshaw Capital Group, Inc. (Nasdaq: RODM), acted as the placement agent for CytRx, and Brean Murray, Carret & Co., Griffin Securities, Inc. and Natixis Bleichroeder Inc. served as financial advisors to CytRx in the placement.

"These are exciting times at CytRx. With the completion of this financing, we are positioned to aggressively pursue our goals of moving tamibarotene and INNO-206 toward commercialization, while evaluating additional opportunities that fit our oncology focus," said Steven A Kriegsman, President and CEO of CytRx. "Our ability to raise funds in a difficult market environment is a testament to the confidence investors have in our strategic focus and the capabilities of our management team and board of directors."

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

The proposed public offering is being made pursuant to an effective registration statement, and may be made only by means of a prospectus and prospectus supplement. A copy of the prospectus and prospectus supplement relating to the common stock and warrants can be obtained from Rodman & Renshaw LLC, 1251 Avenue of the Americas, New York, NY 10020, or by calling 212-356-0549.

An electronic copy of the prospectus supplement will also be available on the website of the Securities and Exchange Commission (the "SEC") at U.S. Securities and Exchange Commission (Home Page).

**paperchase** · #7 07-29-2009, 09:00 AM

CytRx Announces Compliance with NASDAQ's Minimum Bid Requirement
8:30a ET July 27, 2009 (Business Wire)
CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, reported that as of the close of the market on July 24, 2009, CytRx is in compliance with all NASDAQ listing qualifications after its consolidated closing bid price exceeded $1.00 for 10 consecutive days meeting the requirement of NASDAQ Marketplace Rule 4310(c)(8)(D).

"We are delighted that investors appreciate the advancements we are marking with our drug development programs and the potential of our pipeline, and are showing confidence in our strategy and management team," said Steven A. Kriegsman, CytRx President and CEO.

**paperchase** · #8 07-29-2009, 09:11 AM

CytRx Drug Candidate INNO-206 Results in Ovarian Tumor Shrinkage in Animal Trials
8:30a ET July 28, 2009 (Business Wire)
--- Results Slated for Publication in the Peer-reviewed Journal Investigational New Drugs -

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, today announced that results demonstrating that its cancer drug candidate INNO-206 caused statistically significant tumor shrinkage in an animal model of ovarian cancer have been accepted for publication in the peer-reviewed journal Investigational New Drugs. The manuscript based on this animal trial, "INNO-206, the (6-maleimidocaproyl hydrazone derivative of doxorubicin), shows superior antitumor efficacy compared to doxorubicin in different tumor xenograft models and in an orthotopic pancreas carcinoma model," was made available ahead of journal printing in electronic format in the January 8, 2009 on-line issue of Investigational New Drugs.

"Ovarian cancer ranks ninth in prevalence and fifth in mortality among cancers in American women, making it a major women's healthcare concern," said Steven A. Kriegsman, CytRx President and CEO. "Data from this highly promising animal trial showed actual shrinkage of ovarian cancer tumors following treatment with INNO-206 and further add to accumulating evidence that INNO-206 has therapeutic potential in multiple cancer forms."

CytRx has the exclusive worldwide rights to INNO-206, which holds the potential as an effective treatment in a variety of cancer indications, including sarcomas, breast cancer, pancreatic cancer and non-Hodgkin's lymphoma. INNO-206 is a pro-drug derivative of doxorubicin, itself an effective and often prescribed chemotherapeutic drug. INNO-206 is designed to reduce adverse events by controlling drug release and to increase efficacy by preferentially targeting tumors throughout the body, allowing accumulation of the toxic drug at the tumor site. In a Phase 1 study, INNO-206 was administered at up to six times the standard dosing of doxorubicin without an increase in observed side effects compared to those historically seen with doxorubicin.

In the animal study, conducted under the direction of INNO-206 inventor Felix Kratz, Ph.D., Department of Medical Oncology, Clinical Research, at the Tumor Biology Center in Freiburg, Germany, 10 million human A2780 ovarian tumor cells from cell culture were transplanted under the skin in the left flank region of 18 mice with immune systems compromised to allow tumor cell growth. After 10 days, the tumors reached a palpable size and the experimental animals were then randomized into three groups for administration of two cycles of weekly intravenous injections with a previously optimized dose of doxorubicin or CytRx's INNO-206, or received an intravenous injection lacking either drug to serve as a control. Tumor growth was monitored continuously for 12 days following initiation of treatment.

-- In the control group, tumors grew rapidly, increasing in average volume by approximately 20-fold.

-- A statistically significant decrease in the rate of tumor growth compared to the control was observed in the doxorubicin treated group, with tumors increasing in volume by only four- to five-fold during treatment.

-- By contrast to the other two groups of animals, the average tumor growth in animals treated with INNO-206 was completely inhibited, and in fact these tumors shrank in volume, resulting in a net two- to three-fold decrease in tumor volume during treatment. The decrease in average tumor volume in animals treated with INNO-206 was statistically significant (p<0.05) compared to the average tumor volume in both the doxorubicin-treated animals and the control.

CytRx's Chief Scientific Advisor, co-founder of Amgen and noted oncology expert Joseph Rubinfeld, Ph.D., added, "Doxorubicin itself is known to be effective in treating recurrent ovarian cancer in humans so we were not surprised to see its efficacy in this animal model of ovarian cancer. However, the remarkable and statistically significant superiority of INNO-206 compared to this gold standard chemotherapeutic drug in the same experiment increases our confidence that its tumor-targeting mechanism could be key in effectively treating a variety of cancers that respond to drugs like doxorubicin. This has the potential to be of significant value to CytRx stockholders."

About Ovarian Cancer

According to the American Cancer Society (ACS), ovarian cancer is the ninth most prevalent form of cancer but the fifth most common cause of cancer mortality in women in the U.S. with a 45% five-year survival rate. In 2009, approximately 22,000 new cases and almost 15,000 deaths are expected from ovarian cancer in the U.S. alone. The ACS estimates that one out of 71 women will develop ovarian cancer sometime in their life.

About INNO-206

INNO-206 is a prodrug of the commonly prescribed chemotherapeutic doxorubicin and was designed to reduce adverse events by controlling release and preferentially targeting the tumor. In a Phase 1 study, doses were administered at up to six times the standard dosing of doxorubicin without an increase in observed side effects over those historically seen with doxorubicin. The Company is evaluating options for a possible Phase 2 clinical trial.