CytRx Reports 2005 Fourth Quarter Financial Results.LOS ANGELES Los Angeles (lôs ăn`jələs, lŏs, ăn`jəlēz'), city (1990 pop. 3,485,398), seat of Los Angeles co., S Calif.; inc. 1850. -- CytRx Corporation (Nasdaq:CYTR CYTR Canadian Yorkshire Terrier Rescue CYTR Constant Yield Tax Rate (property tax) ), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, today reported financial results for the fourth quarter and year ended December 31, 2005. "I am delighted to report that our achievements during the past year have brought us closer to our goal of commercializing human therapeutics based on our small molecule 'molecular chaperone' co-induction technology," said CytRx President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. Steven A. Kriegsman. "Most notable among our achievements in 2005 was the advancement of our orally-available small molecule drug candidate arimoclomol into Phase II development for the treatment of amyotrophic lateral sclerosis amyotrophic lateral sclerosis (ALS) (ā'mīətrōf`ik, sklĭrō`sĭs) or motor neuron disease, , also know as ALS Als (äls), Ger. Alsen, island, 121 sq mi (313 sq km), Sønderjylland co., S Denmark, in the Lille Bælt, separated from the mainland by the narrow Alensund. or Lou Gehrig's disease Lou Geh·rig's disease n. See amyotrophic lateral sclerosis. . "We also made excellent progress in our HIV vaccine HIV vaccine AIDS As of mid-2005, there is no viable anti-HIV vaccine. See AIDS. program. Interim results from a Phase I trial indicate our novel DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. + protein vaccine is the first to produce potent antibody responses with neutralizing activity against multiple HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. viral strains, and we expect to announce final results from this trial next quarter," Mr. Kriegsman added. Review of Financial Results For the fourth quarter of 2005, CytRx reported a net loss of $3.6 million, or $0.06 per share, compared with a net loss of $5.8 million, or $0.15 per share, for the fourth quarter of 2004. Revenue for the fourth quarter of 2005 was $173,000, compared with $100,000 in the fourth quarter of 2004. Revenue in both periods included $100,000 of license fees paid with respect to CytRx's TranzFect vaccine adjuvant adjuvant /ad·ju·vant/ (aj?dbobr-vant) (a-joo´vant) 1. assisting or aiding. 2. a substance that aids another, such as an auxiliary remedy. 3. technology. Revenue in the fourth quarter of 2005 also included $73,000 of service revenue. All future licensing fees under current licensing agreements are dependent upon successful development milestones being achieved by the licensor. Research and development (R&D) expenses were $2.3 million in the fourth quarter of 2005 versus $4.1 million in the comparable period in 2004. R&D expenses in the fourth quarter of 2004 included a $3 million expense of certain costs associated with the acquisition of compounds from Biorex Research and Development, RT. General and administrative expenses were $1.5 million for the 2005 fourth quarter, compared with $1.8 million for the 2004 fourth quarter. The net loss for the year ended December 31, 2005, was $15.1 million, or $0.27 per share, compared with a net loss of $16.4 million, or $0.48 per share, for the year ended December 31, 2004. Revenue for the year ended December 31, 2005, was $184,000, compared with $428,000 for the year ended December 31, 2004. Revenue for 2005 included $100,000 of license fees paid with respect to CytRx's TranzFect technology and $83,000 of service revenue, while 2004 revenue consisted entirely of license fees. Total operating costs operating costs npl → gastos mpl operacionales and expenses for the year ended December 31, 2005 were $15.7 million, versus $17.0 million in 2004. As of December 31, 2005, cash and cash equivalents totaled $8.3 million, compared with $3.0 million as of December 31, 2004. The increase reflects completion of a private placement in January 2005 with net proceeds Net Proceeds The amount received after all costs are deducted from the sale of a piece of property or security. Notes: In the case of an investor selling a security, net proceeds represent the proceeds from the sale minus any trading costs (i.e. commissions). to the Company of $19.4 million. Working capital was $6.3 million as of December 31, 2005, compared with $1.2 million as of December 31, 2004. In March 2006, CytRx received approximately $12.4 million in net proceeds from the private sale of common stock and warrants. 2005 and Recent Highlights Significant accomplishments made by CytRx during the past year include: Arimoclomol for ALS Program In September 2005, CytRx initiated a 10-center, 80-patient Phase IIa clinical trial with arimoclomol for ALS, a deadly neurodegenerative disorder neurodegenerative disorder Neurology A chronic progressive neuropathy characterized by selective and generally symmetrical loss of neurons in motor, sensory, or cognitive systems Types by area Cerebral cortex–Alzheimer's disease, Pick's disease, Lewy body with no effective treatment. CytRx expects to complete enrollment shortly. During 2005, the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) granted orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the status and fast track designation to arimoclomol for the treatment of ALS. CytRx expects to complete the Phase IIa trial in the third quarter of 2006 and then commence a Phase IIb efficacy trial for arimoclomol, subject to FDA review and approval. CytRx believes that successfully demonstrating safety and efficacy in this latter Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II could be sufficient to support product registration with the FDA. In February 2006, CytRx initiated an open-label extension trial with arimoclomol for patients who have completed the Phase IIa clinical trial. Patients in the extension trial receive treatment with arimoclomol at the highest of the three Phase IIa dose levels for up to an additional six months. The open label extension trial is designed to provide additional safety and tolerability data in combination with the current Phase IIa trial. HIV Vaccine Program World health officials estimate 40 million people are now infected with HIV. Some 3 million people died of AIDS last year worldwide, and millions more are expected to die from AIDS this year. In March 2005, the enrollment of healthy volunteers in a three-arm Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I of DP6-001, a novel polyvalent polyvalent /poly·va·lent/ (-va´lent) multivalent. pol·y·va·lent adj. 1. Acting against or interacting with more than one kind of antigen, antibody, toxin, or microorganism. 2. HIV DNA + protein vaccine, was completed. The HIV vaccine formulation, which is exclusively licensed to CytRx, was created by researchers at the University of Massachusetts Medical School UMMS is ranked fourth in primary care education among the nation’s 125 medical schools in the 2006 U.S.News & World Report annual guide, “America’s Best Graduate Schools”. UMMS is also a major center for research. (UMMS UMMS University of Massachusetts Medical School (North Worcester, Massachusetts) UMMS University of Maryland Medical System UMMS United Methodist Missionary Society ) and Advanced BioScience Laboratories (ABL) and funded under a $16 million five-year HIV Vaccine Design and Development Team contract from the National Institute of Allergy and Infectious Diseases infectious diseases: see communicable diseases. (NIAID NIAID National Institute of Allergy and Infectious Diseases. ), part of the National Institutes of Health (NIH "Not invented here." See digispeak. NIH - The United States National Institutes of Health. ). Interim results of the trial indicated that the HIV vaccine was generally well-tolerated, stimulated immune "T-cells" that potentially can attack AIDS virus-infected cells and produced potent antibody responses with neutralizing activity against multiple HIV viral strains. Preliminary results suggested that even the lowest dosage of the DNA portion of the vaccine alone was sufficient to stimulate T-cell immune response immune response n. An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. . As HIV is a highly mutating viral disease, the ability of one vaccine to neutralize multiple strains simultaneously could be essential and has been considered among the primary challenges to development of a successful HIV vaccine. CytRx expects to announce final results from the Phase I trial of its HIV vaccine in the second quarter of 2006. RNAi-based Drug Discovery Programs CytRx is developing ribonucleic acid Ribonucleic acid (RNA) One of the two major classes of nucleic acid, mainly involved in translating into proteins the genetic information that is carried in deoxyribonucleic acid (DNA). interference (RNAi) as a tool to identify drug targets as part of an expanded collaborative agreement with UMMS. Over the past year, research programs have discovered and validated approximately 30 new type 2 diabetes type 2 diabetes n. See diabetes mellitus. and obesity drug targets with the use of CytRx's high-throughput RNAi screening platform. Extension of the RNAi screening platform includes muscle and liver cells in addition to fat cells. In August 2005, CytRx advanced RNAi against RIP 140, a nuclear hormone co-repressor that regulates fat accumulation, into development for the treatment of type 2 diabetes and obesity. In addition, the Company advanced two proprietary small molecule leads against novel upstream AMP-activated protein kinase 5'AMP-activated protein kinase or AMPK consists of three proteins (subunits) that together make a functional enzyme, conserved from yeast to humans, that plays a role in cellular energy homeostasis. targets into proof-of-concept animal experiments. In early 2006, CytRx announced plans to transfer all of its RNAi therapeutics assets into a newly-formed subsidiary to accelerate the development and commercialization of RNAi drugs. Formation is expected to be completed in the coming months, subject to obtaining financing to fund the separate RNAi business. CytRx expects to retain significant ownership in the new entity. Other corporate highlights include the following: Scientific Advisory Board In September 2005, Geoffrey Burnstock Geoffrey Burnstock (b. 1929) is Emeritus Professor and President of the Autonomic Neuroscience Centre of the Royal Free and University College Medical School. He played a key role in the discovery of ATP as neurotransmitter. , Ph.D., DSc., F.A.A., FMedSci, FRS FRS abbr. Fellow of the Royal Society FRS, n “flexed rotated side-bent,” an osteopathic abbreviation used to describe vertebral position in cases of spinal dysfunction. , one of the world's foremost neuroscientists, joined the CytRx Scientific Advisory Board. He was named by The Institute of Scientific Information in 2004 as the single most cited international scientist in pharmacology and toxicology during the prior decade. He has been awarded the prestigious Queen's Royal Gold Medal The Royal Gold Medal for architecture is awarded annually by the Royal Institute of British Architects on behalf of the British monarch, in recognition of an individual's or group's substantial contribution to international architecture. by the Royal Society and the titles of Honorary Fellow of the Royal College of Surgeons and Honorary Fellow of the Royal College of Physicians The Royal College of Physicians of London was the first medical institution in England to receive a Royal Charter. It was founded in 1518 and is one of the most active of all medical professional organisations. , which are among the United Kingdom's highest medical degrees. Professor Burnstock played a major role in the development of arimoclomol. Research Publications The January 2006 issue of peer-reviewed The Journal of Clinical Investigation The Journal of Clinical Investigation (JCI or J Clin Invest) is a leading biomedical journal, which is radically different from many of its peers in having a high impact factor (in 2006, 15.754) and offering all its contents entirely free. included a significant CytRx-funded research article highlighting for the first time that RIP140 suppression by RNAi in cell culture enhances insulin responsiveness and oxidative metabolism. Michael P. Czech, Ph.D., professor and chair of molecular medicine at UMMS, was the principal author of the article entitled "Suppression of oxidative metabolism and mitochondrial mitochondrial pertaining to mitochondria. mitochondrial RNAs a unique set of tRNAs, mRNAs, rRNAs, transcribed from mitochondrial DNA by a mitochondrial-specific RNA polymerase, that account for about 4% of the total cell RNA that biogenesis biogenesis /bio·gen·e·sis/ (-jen´e-sis) 1. origin of life, or of living organisms. 2. the theory that living organisms originate only from other living organisms. by the transcriptional co-repressor RIP140 in mouse adipocytes." Dr. Czech serves as Chairman of the CytRx Metabolic Scientific Advisory Board. About CytRx Corporation CytRx Corporation is a biopharmaceutical research and development company engaged in the development of high value human therapeutics. The Company owns three clinical-stage compounds based on its small molecule "molecular chaperone chaperone /chap·er·one/ (shap´er-on) someone or something that accompanies and oversees another. molecular chaperone " co-induction technology (CCI CCI Chambre de Commerce et d'Industrie (France) CCI CAM (Complementary and Alternative Medicine) Citation Index CCI Chamber of Commerce and Industry (Western Australia) ), as well as a targeted library of 500 small molecule CCI analogs. CytRx has initiated a Phase IIa clinical trial with its lead CCI small molecule product candidate arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). Arimoclomol has received orphan drug status and fast track designation from the U.S. Food and Drug Administration. CytRx has previously announced that a novel polyvalent HIV DNA + protein vaccine exclusively licensed to CytRx and developed by researchers at UMMS and Advanced BioScience Laboratories, and funded by the National Institutes of Health, demonstrated very promising interim Phase I clinical trial results that indicate its ability to produce potent antibody responses with neutralizing activity against multiple HIV viral strains. CytRx also has a broad-based strategic alliance with UMMS to develop novel compounds in the areas of ALS, obesity, type 2 diabetes and cytomegalovirus cytomegalovirus (sī'təmĕg'əlōvī`rəs), member of the herpesvirus family that can cause serious complications in persons with weakened immune systems. (CMV CMV cytomegalovirus. CMV abbr. 1. controlled mechanical ventilation 2. cytomegalovirus Cytomegalovirus (CMV) ) using RNAi technology. The Company has a research program with Massachusetts General Hospital Massachusetts General Hospital Health care The major teaching hospital for Harvard Medical School, widely regarded as one of the best health care centers in the world , Harvard University's teaching hospital, to use RNAi technology to develop a drug for the treatment of ALS. CytRx Drug Discovery division, located in Worcester, MA focuses on the use of RNAi technologies to develop small molecule and RNAi therapeutics to treat obesity and type 2 diabetes. For more information, visit CytRx's Web site at www.cytrx.com. About the University of Massachusetts Medical School The University of Massachusetts Medical School, one of the fastest growing academic health centers in the country, has built a reputation as a world-class research institution, consistently producing noteworthy advances in clinical and basic research. The Medical School attracts more than $174 million in research funding Research funding is a term generally covering any funding for scientific research, in the areas of both "hard" science and technology and social science. The term often connotes funding obtained through a competitive process, in which potential research projects are evaluated and annually, 80% of which comes from federal funding sources. Research funding enables UMMS scientists to explore human disease from the molecular level to large-scale clinical trials. Basic and clinical research leads to new approaches for diagnosis, treatment and prevention of disease. Visit www.umassmed.edu for additional information. About Advanced BioScience Laboratories Advanced BioScience Laboratories, Inc. (ABL) located in Kensington, Md., is a biomedical research Biomedical research (or experimental medicine), in general simply known as medical research, is the basic research or applied research conducted to aid the body of knowledge in the field of medicine. , development and manufacturing company focusing on human retroviral diseases. ABL has been a leader in HIV-1 research for more than two decades and has been involved in the development of methods to both prevent and treat HIV-1 infection. Forward-Looking Statements This press release may contain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Examples of such statements include, but are not limited to, statements relating to the expected timing, scope and results of our clinical development and research programs, including the initiation of clinical trials, and statements regarding the potential benefits of our drug candidates and potential drug candidates. 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 regarding the scope of the clinical testing that may be required by regulatory authorities for our molecular chaperone co-induction drug candidates, including with respect to arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), our HIV vaccine candidate and our other product candidates, and the outcomes of those tests; uncertainties related to the early stage of our diabetes, obesity, cytomegalovirus, or CMV, and ALS research; the need for future clinical testing of any small molecules and products based on ribonucleic acid interference, or RNAi, that may be developed by us; the significant time and expense that will be incurred in developing any of the potential commercial applications for our small molecules or RNAi technology; risks or uncertainties related to our ability to obtain capital to fund our ongoing working capital needs, including capital required to fund the RNAi development activities to be conducted by our planned new subsidiary; and risks relating to the enforceability of any patents covering our products and to the possible infringement of third party patents by those products.. Additional uncertainties and risks are described in CytRx's most recently filed SEC documents, such as its most recent annual report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. , all quarterly reports on Form 10-Q Form 10-Q See 10-Q. and any current reports on Form 8-K Form 8-K The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock. Form 8-K See 8-K. filed since the date of the last Form 10-K. 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.
CYTRX CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(Audited)
December 31, December 31,
2005 2004
------------- --------------
ASSETS
Current assets:
Cash and short-term investments $8,299,390 $2,999,409
Accounts Receivable 172,860 --
Prepaid and other current assets 315,606 956,146
------------- --------------
Total current assets 8,787,856 3,955,555
Property and equipment, net 352,641 447,579
Molecular library, net 372,973 447,567
Goodwill 183,780 --
Prepaid insurance and other assets 241,660 198,055
------------- --------------
Total assets $9,938,910 $5,048,756
============= ==============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $815,626 $1,661,104
Accrued expenses and other
current
liabilities 1,639,922 1,074,146
------------- --------------
Total current liabilities 2,455,548 2,735,250
Accrued loss on facility abandonment -- 206,833
Deferred gain on sale of building -- 65,910
Deferred revenue 275,000 275,000
------------- --------------
Total liabilities 2,730,548 3,282,993
------------- --------------
Minority interest in subsidiary -- 170,671
------------- --------------
Commitments and contingencies -- --
Stockholders' equity:
Preferred stock, $.01 par value,
5,000,000 shares authorized,
including 5,000 shares of Series A
Junior Participating Preferred
Stock; no shares issued and
outstanding -- --
Common stock, $.001 par
value, 125,000,000 shares
authorized; 59,284,000 and
40,190,000 shares issued at
December 31, 2005 and
2004, respectively 59,284 40,190
Additional paid-in capital 130,715,363 110,028,327
Treasury stock, at cost (634,000
shares, at cost, held at December
31, 2005 and 2004) (2,279,238) (2,279,238)
Accumulated deficit (121,287,047) (106,194,187)
------------- --------------
Total stockholders' equity 7,208,362 1,595,092
------------- --------------
Total liabilities and
stockholders' equity $9,938,910 $5,048,756
============= ==============
CYTRX CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Audited)
Three Months Ended Twelve Months Ended
December 31, December 31,
--------------------------------------------------
2005 2004 2005 2004
--------------------------------------------------
Revenues:
Service revenues $72,860 $-- $82,860 $--
License fees 100,000 100,000 101,500 428,164
--------------------------------------------------
172,860 100,000 184,360 428,164
--------------------------------------------------
Expenses:
Research and
development
(includes $98,000
and $220,000 of
non-cash stock-
based expense for
the three and
twelve-month
periods ended
December 31, 2005,
respectively, and
$53,000 and
$1,388,000 of non-
cash stock-based
expense for the
three and twelve-
month periods
ended December 31,
2004,
respectively) 2,266,318 4,066,409 9,087,270 9,034,855
Depreciation and
amortization 58,610 30,215 217,095 103,851
Common stock, stock
options and
warrants issued
for general and
administrative
services 24,191 1,037,729 366,753 1,977,330
General and
administrative 1,470,551 780,868 6,057,353 5,923,910
--------------------------------------------------
3,819,670 5,915,221 15,728,471 17,039,946
--------------------------------------------------
Loss before other
income (3,646,810) (5,815,221) (15,544,111) (16,611,782)
Other income:
Gain on lease
termination -- -- 163,604 --
Interest income 82,045 9,229 206,195 59,977
Minority interest
in losses of
subsidiary -- 44,006 81,452 159,616
--------------------------------------------------
Net loss $(3,564,765)$(5,761,986)$(15,092,860)$(16,392,189)
==================================================
Basic and diluted:
Loss per common
share $(0.06) $(0.15) $(0.27) $(0.48)
==================================================
Weighted
average shares
outstanding 58,290,651 39,555,872 56,852,402 34,325,636
==================================================
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