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Cel-Sci Corp. in the News!
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February 2, 2024

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Dow Jones 8,784.95 +8.77 1:00 pm PST, January 10, 2003  NASDAQ 1,447.75 +9.29 For info, visit access.smallcapnetwork.com S & P 500 927.57 0.00 To be removed, please click here Russell 2000 396.44 +0.50 VOLUME 02: ISSUE 88 Cel-Sci in the News Today, just after the market closed, Cel-Sci Corporation announced its year end financial results. In conjunction, the company announced an additional round of financing for $1.35 million, which will provide enough working capital for another year and allow the company to pursue Stage III trials for its immunotherapy drug Multikine.  Losses came in at expectations. The company also announced it expected a substantial reduction in overhead in 2003, as signficant costs were experienced in 2002 in pursuing FDA Approval of its manufacturing facilities. That process is now nearly complete, and paves the way for Stage III clinical trials later this year. (See the bottom of this page for the complete news release) Detailing Cel-Sci's Vision Before you read about Virginia-based Cel-Sci's immunotherapy drug Multikine, take a moment to consider the basic definition of immunotherapy: "Treatment to stimulate or restore the ability of the immune system to fight infection and disease. Also used to lessen side effects that may be caused by some cancer treatments. " The above concept could be expanded to include immunotherapy drugs' potential to enhance the efficacy of cancer treatments such as surgery, chemotherapy and radiation.  The course that Cel-Sci is following in its development of Multikine has been ignored by big pharmaceutical companies that tend to be more focused on making profits by selling drugs and therapies to cancer patients in the last six months of life.  Therapies for early detection and treatment, such as Cel-Sci is developing, are deemed too risky and too expensive to develop. For big pharma it is, frankly, more profitable to wade in after the cancer has become incurable. Ironically, the market for immunotherapy drugs such as Multikine is much larger than those markets traditionally sold and marketed to by the pharmaceutical companies.  A Company Thinking Differently Multikine is not an anti-cancer drug; it is an immune stimulant. In essence, it supercharges the immune system making the lymph nodes relay stations to manufacture cancer-killing cells. The types of cancers that affect the head and neck, historically, have had a survival rate of less than 50 percent.  Head & neck cancer: Phase I and Phase II clinical trials encompassing about 160 head & neck cancer patients have demonstrated dramatic tumor reduction, with over 20-40% of patients treated with Multikine at the most effective doses and treatment regimens experiencing a greater than 50% reduction in tumor size, or complete responses, following treatment. Also, all eight head & neck cancer patients in a Phase II clinical trial who were treated at one European center with Multikine in combination with surgery/radiation over 2 years ago, have NOT had recurrences to date and remain alive. This finding is very encouraging because it is generally expected that approximately 50% of such patients would have experienced recurrences at 18-24 months post treatment. Recurrence of the disease usually leads to death. (www.cel-sci.com) Therein lies the opportunity for the folks at Cel-Sci, who have, over the last two decades, brought Multikine to the point where Phase Three trails should be approved later this year and begun in 2004-- bringing this revolutionary drug closer to the final step of FDA approval. The market for head and neck cancer treatments is, conservatively, $1.5 billion in the US and Europe alone. In Asia, where the occurrence of this form of cancer is much higher, Cel-Sci has already developed partnerships. There are more than half a million head and neck cancer cases diagnosed annually worldwide (over 100,000 in the US alone).  Once other cancers are targeted, the potential market for Multikine rises exponentially. Unfortunately, demographics will work in Cel-Sci's favor for many years: as the global population ages, the number of annually diagnosed cancer cases will only increase. Immune to Cancer Multikine replicates a healthy immune system in those diagnosed with cancer in the early stages. Going forward, the drug's ability to bolster a compromised immune system will benefit patients by enhancing the initial treatments for many types of cancer.  Cel-Sci, currently trading at 20 cents and with a market cap of $9.4 million, represents an interesting speculative investment for both traders and holders. Once Phrase Three trials are approved-likely later this year-Cel-Sci will move into a new echelon of acceptance within both the pharmaceutical and investment communities. CEO Geert Kersten is very confident about the year ahead and the approval for Phase Three trails.  The company would then be able to publish the type of data that would prove Multikine's efficacy. Kersten and his team are presently spending 90 percent of their corporate time completing the administrative tasks necessary for the FDA to approve Phase Three trials. With the recent injection of $1.35 million of new private funding, the company is well financed for the next year-the major developmental expenses, totaling $65 million, are already behind it. As a result, overhead for the coming year will be reduced by 25 percent. Injecting Simplicity into Cancer Treatment The process for administering Multikine is quite simple. Following diagnosis, as a pre-treatment, the drug is injected around the tumor, daily, for a period of two weeks followed by a one week waiting period. The goal is not only to eliminate or shrink a head/neck tumor, but to eliminate the localized cancer cells around it that can be missed during surgery. The recurrence of the tumor is greatly reduced, as the localized cells are the sites where the cancer, historically, has returned and in a majority of cases, ultimately killed the patient. The next sites are the lymph nodes --where more cancer cells can migrate-- which after injection, will trigger the necessary immune response to fight recurrence. As Multikine is an immunotherapy-based protocol; potentially effective against several types of cancer such as breast and, as shown in a Phase One trial, in the treatment of cervical dysplasia/cancer.  Cervical dysplasia in HIV-infected patients: Results from an ongoing Phase I clinical trial of Multikine in cervical dysplasia in HPV/HIV co-infected women indicate elimination or reduction of dysplasia in 71% of the patients and excellent treatment tolerance. The assumption by the physicians is that a product that shows benefit in HIV-infected women with cervical dysplasia will show an even better response in non-HIV-infected women with cervical dysplasia, a world-wide market of over 20 million women. (www.cel-sci.com) In essence, Multikine can make fundamental changes in a patient's ability to respond to cancer. The drug supercharges the immune system, resulting in the patient's own body becoming the best weapon in the fight against this horrific disease. Partners, Papers and Progress Cel-Sci, while focused on FDA approval of Phase Three trials later this year is in discussions with several potential partners. Once that occurs, the company anticipates Multikine will be the subject of scientific papers and investment analysts' reports, bringing it the positive attention it has worked toward for the last two decades. With the shares currently trading at 20 cents-it has challenged 30 cents a half dozen times in the last several months-it makes a compelling--albeit speculative-- investment for those who wish to participate in a biotech company that truly thinks outside the traditional cancer treatment 'box'. Further information can be found in our November Profile of Cel-Sci as well as at the company's website www.cel-sci.com. Here's the complete text of the news release for your review:   CEL-SCI Corporation Announces 2002 Financial Results and $1.35 Million in New Funding Friday January 10, 4:15 pm ET Success in Two Key Areas is Expected to Lead to Significantly Reduced Expenses in Fiscal Year 2003 VIENNA Va., Jan. 10 /PRNewswire-FirstCall/ -- CEL-SCI CORPORATION (Amex: CVM - News) reports financial results for the 2002 fiscal year ending September 30, 2002.   During fiscal year 2002, grant revenues were $384,939 as compared with $293,871 during fiscal year 2001. The Company reported a net loss for fiscal year 2002 of $8,342,244, or ($0.35) per share, versus a net loss of $10,733,679, or ($0.51) per share, reported for fiscal year 2001. CEL-SCI also closed on the first part of a $1.35 million funding. The second part is expected to close during the first quarter of this year. "During fiscal year 2002 we were able to complete our multi-year manufacturing validation program for our lead product Multikine(TM) and complete our last Phase II clinical trial of Multikine in the treatment of head & neck cancer," stated Geert Kersten, Chief Executive Officer of CEL-SCI Corporation. "With these very expensive achievements behind us, we expect the cash expenditures for fiscal year 2003 to be reduced even further compared to fiscal year 2002 while we focus on the administrative processes required for the next step in gaining FDA approval to initiate our Phase III clinical trial in head & neck cancer." Multikine is an immunotherapy drug that is being developed against head & neck cancer and HPV-induced cervical dysplasia/cancer. The drug has shown very promising tumor responses in over 190 cancer and HIV+ patients.                              CEL-SCI CORPORATION                     CONSOLIDATED STATEMENTS OF OPERATIONS                    YEARS ENDED SEPTEMBER 30, 2002 AND 2001                                                     2002              2001     GRANT REVENUE AND OTHER                       $384,939          $293,871     OPERATING EXPENSES:       Research and development                   4,699,909         7,762,213       Depreciation and amortization                226,514           209,121       General and administrative                 1,754,332         3,432,437                Total operating expenses          6,680,755        11,403,771     NET OPERATING LOSS                          (6,295,816)      (11,109,900)     INTEREST INCOME                                 85,322           376,221     INTEREST EXPENSE                            (2,131,750)               --     NET LOSS                                    (8,342,244)      (10,733,679)     ACCRUED DIVIDENDS ON       PREFERRED STOCK                             (202,987)          (53,153)     ACCRETION OF BENEFICIAL CONVERSION       FEATURE ON PREFERRED STOCK                (1,444,757)         (317,419)     NET LOSS ATTRIBUTABLE TO COMMON       STOCKHOLDERS                             $(9,989,988)     $(11,104,251)     NET LOSS PER COMMON SHARE (BASIC)               $(0.35)           $(0.51)     NET LOSS PER COMMON SHARE (DILUTED)             $(0.35)           $(0.51)     WEIGHTED AVERAGE COMMON SHARES       OUTSTANDING                               28,746,341        21,824,273 When used in this report, the words "intends," "believes," "anticipated" and "expects" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI Corporation's SEC filings, including but not limited to its report on Form 10- K for the year ended September 30, 2002. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. 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