<SEC-DOCUMENT>0001654954-22-011627.txt : 20220822
<SEC-HEADER>0001654954-22-011627.hdr.sgml : 20220822
<ACCEPTANCE-DATETIME>20220822090037
ACCESSION NUMBER:		0001654954-22-011627
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		16
CONFORMED PERIOD OF REPORT:	20220819
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20220822
DATE AS OF CHANGE:		20220822

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			CEL SCI CORP
		CENTRAL INDEX KEY:			0000725363
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				840916344
		STATE OF INCORPORATION:			CO
		FISCAL YEAR END:			0930

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-11889
		FILM NUMBER:		221182341

	BUSINESS ADDRESS:	
		STREET 1:		8229 BOONE BLVD .
		STREET 2:		SUITE 802
		CITY:			VIENNA
		STATE:			VA
		ZIP:			22182
		BUSINESS PHONE:		7035069460

	MAIL ADDRESS:	
		STREET 1:		8229 BOONE BLVD.
		STREET 2:		SUITE 802
		CITY:			VIENNA
		STATE:			VA
		ZIP:			22182

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	INTERLEUKIN 2 INC
		DATE OF NAME CHANGE:	19880317
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>cvm_8k.htm
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FONT-FAMILY: times new roman; MARGIN: 0px; TEXT-INDENT: 45px; text-align:justify;">On August 19, 2022, the Company issued a press release, filed as Exhibit 99, concerning the results of the Company's Phase 3 Multikine head and neck cancer clinical trial which was posted on clinicaltrials.gov.</p><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&#160;</p><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"><strong>Item 9.01 Financial Statements and Exhibits.</strong></p><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&#160;</p><table style="border-spacing:0;font-size:10pt;text-align:left;width:100%" cellpadding="0"><tbody><tr style="height:15px"><td style="BORDER-BOTTOM: #000000 1px solid;width:9%;"><p style="font-size:10pt;font-family:times new roman;margin:0px">Exhibit No.</p></td><td style="width:1%;"><p style="font-size:10pt;font-family:times new roman;margin:0px">&#160;</p></td><td style="BORDER-BOTTOM: #000000 1px solid;"><p style="font-size:10pt;font-family:times new roman;margin:0px">Description</p></td></tr><tr style="height:15px"><td><p style="font-size:10pt;font-family:times new roman;margin:0px">&#160;</p></td><td><p style="font-size:10pt;font-family:times new roman;margin:0px">&#160;</p></td><td><p style="font-size:10pt;font-family:times new roman;margin:0px">&#160;</p></td></tr><tr style="height:15px;background-color:#cceeff"><td><p style="font-size:10pt;font-family:times new roman;margin:0px"><a href="cvm_ex991.htm">99.1</a></p></td><td><p style="font-size:10pt;font-family:times new roman;margin:0px">&#160;</p></td><td><p style="FONT-SIZE: 10pt; 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Phase 3 Trial Results on Clinicaltrials.gov</a></p></td></tr></tbody></table><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&#160;</p><table style="border-spacing:0;font:10pt times new roman;width:100%" cellpadding="0"><tbody><tr style="height:15px"><td class="hpbhr">&#160;</td></tr><tr style="height:15px"><td style="BORDER-BOTTOM: black 1px solid; TEXT-INDENT: 0px;text-align:center;">2</td></tr><tr style="height:15px"><td><p style='page-break-after: always'></p></td></tr><tr style="height:15px"><td>&#160;</td></tr></tbody></table><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&#160;</p><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:center;"><strong>SIGNATURES</strong></p><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&#160;</p><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; TEXT-INDENT: 45px; text-align:justify;">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.</p><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&#160;</p><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">Date: August 22, 2022</p><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&#160;</p><table style="border-spacing:0;font:10pt times new roman;width:100%" cellpadding="0"><tbody><tr style="height:15px"><td>&#160;</td><td colspan="2"><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"><strong>CEL-SCI CORPORATION</strong></p></td><td></td></tr><tr style="height:15px"><td style="width:47%;">&#160;</td><td style="width:3%;">&#160;</td><td style="width:30%;">&#160;</td><td style="width:15%;">&#160;</td></tr><tr style="height:15px"><td></td><td>By:</td><td style="BORDER-BOTTOM: black 1px solid;">/s/ Patricia Prichep</td><td></td></tr><tr style="height:15px"><td><p style="font-size:10pt;font-family:times new roman;margin:0px">&#160;</p></td><td><p style="font-size:10pt;font-family:times new roman;margin:0px">&#160;</p></td><td>Patricia B. Prichep</td><td>&#160;</td></tr><tr style="height:15px"><td>&#160;</td><td>&#160;</td><td><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:left;">Senior Vice President of Operations</p></td><td>&#160;</td></tr></tbody></table><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&#160;</p><table style="border-spacing:0;font:10pt times new roman;width:100%" cellpadding="0"><tbody><tr style="height:15px"><td class="hpbhr">&#160;</td></tr><tr style="height:15px"><td style="BORDER-BOTTOM: black 1px solid; TEXT-INDENT: 0px;text-align:center;">3</td></tr></tbody></table><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&#160;</p></body></html>
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<TYPE>EX-99.1
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<DESCRIPTION>PRESS RELEASE
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<html><head><title>cvm_ex991.htm</title><!--Document created using EDGARMaster--></head><body style="TEXT-ALIGN: justify; FONT: 10pt times new roman"><p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp; </p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:right;"><strong>EXHIBIT 99.1</strong></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="margin:0px"> <table style="border-spacing:0;font-size:10pt;text-align:left;width:100%" cellpadding="0"> <tr style="height:15px"> <td style="BORDER-BOTTOM: #000000 1px solid;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><img src="cvm_ex99img2.jpg"></p></td> <td style="BORDER-BOTTOM: #000000 1px solid;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="BORDER-BOTTOM: #000000 1px solid;"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:right;"><font style="font-size:18pt"><font style="color:#7e7e7e">&nbsp;<strong>NEWS RELEASE</strong></font></font></p></td></tr></table></p> <p style="margin:0px"></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">8229 Boone Boulevard, Suite 802<strong><em> &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;</em></strong></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">Vienna, VA&nbsp; 22182.&nbsp; USA&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp; </p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">Telephone (703) 506-9460&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;<strong>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </strong></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">www.cel-sci.com</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:center;">CEL-SCI CORPORATION ANNOUNCES PHASE 3 MULTIKINE<sup style="vertical-align:super">&#174;</sup> HEAD AND NECK CANCER RESULTS POSTED ON CLINICALTRIALS.GOV </p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;"><em><u>The &#8220;Proposed Indication&#8221; for Multikine that will be submitted to the FDA in a license application will be limited by certain eligibility criteria to patients who would be deemed by NCCN Guidelines as having a lower risk for tumor recurrence.&nbsp; The Standard of Care for lower risk for tumor recurrence advanced primary head and neck cancer patients is surgery followed by radiotherapy, but not chemotherapy</u></em>.<em> Note that the term &#8220;lower risk for recurrence&#8221; should not be confused with a low risk of death, because the 5-year survival for such patients is still less than 50%, even after receiving the current standard of care (SOC). The Proposed Indication for Multikine would cover an estimated 210,000 patients globally each year.</em></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;"><em>Data collected during the Phase 3 trial that will be submitted to FDA in support of the Proposed Indication are:</em></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="margin:0px"> <table style="border-spacing:0;text-align:left;font:10pt times new roman;width:100%" cellpadding="0"> <tr style="height:15px"> <td style="width:4%;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="width:4%;vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><font style="font-family:symbol">&#183;</font></p></td> <td style="vertical-align:top;"><em><u>Partial and complete tumor responses within 3 weeks and before surgery (objective responses per RECIST):</u></em></td></tr></table></p> <p style="margin:0px"></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="margin:0px"> <table style="border-spacing:0;text-align:left;font:10pt times new roman;width:100%" cellpadding="0"> <tr style="height:15px"> <td style="width:8%;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="width:4%;vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">o </p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><em>8.1% (32/395) objective response rate (ORR) for Multikine+CIZ patients in the intent-to-treat (ITT) population versus zero in the SOC group (n=394).</em></p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">o<em> </em></p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><em>15.2% (24/158) ORR for Multikine+CIZ patients in the lower-risk-for-recurrence arm versus zero in the SOC group (n=168). </em></p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">o<em> </em></p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><em>Two-sided Fisher Exact p-values &lt;0.0000001 for ORR. </em></p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">o<em> </em></p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><em>Complete responses before surgery were seen in 5 Multikine+CIZ patients. </em></p></td></tr></table></p> <p style="margin:0px"></p> <p style="FONT-SIZE: 10pt; 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FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"><em>In the ITT population, 22.2% death rate versus 54.1% death rate (Multikine objective responders versus Multikine non-responders; two-sided Fisher Exact p-value &lt;0.0001; HR=0.301 [95% CI 0.16, 0.566]).</em></p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">o<em> </em></p></td> <td style="vertical-align:top;"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"><em>In the lower-risk-for-recurrence arm, 12.5% death rate versus 41.0% death rate (Multikine+CIZ objective responders versus Multikine+CIZ non-responders; 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This arm comprised about 40% of all study participants.</em></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><font style="font-family:symbol">&#183;</font></p></td> <td style="vertical-align:top;"><em><u>14.1% absolute OS advantage at 5-years</u></em><em> in the lower-risk-for-recurrence arm (62.7% vs 48.6%) for Multikine+CIZ patients versus SOC patients. OS benefit was also shown at 1, 2, 3, and 4 years.</em></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><font style="font-family:symbol">&#183;</font></p></td> <td style="vertical-align:top;"><em><u>Nearly 4-year increase in median overall survival</u></em><em> in the lower-risk-for-recurrence arm (101.7 months for Multikine+CIZ versus 55.2 months for the SOC).</em></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><font style="font-family:symbol">&#183;</font></p></td> <td style="vertical-align:top;"> <p style="MARGIN: 0px; text-align:justify;"><em><u>Histopathological analysis confirmed the effect of Multikine,</u></em><em> as 61 markers, ratios, and combinations showed a statistically significant effect in the lower-risk-for-recurrence arm (two-sided p&lt;0.05) favoring Multikine+CIZ versus the SOC for OS, progression free survival, and loco-regional control outcomes.</em></p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><font style="font-family:symbol">&#183;</font></p></td> <td style="vertical-align:top;"><em><u>Additional (confirmatory) progression-free survival benefit</u></em><em> in the lower-risk-for-recurrence arm was observed for Multikine+CIZ versus the SOC.</em></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><font style="font-family:symbol">&#183;</font></p></td> <td style="vertical-align:top;"><em><u>No excess safety issues</u></em><em>: The overall incidence of adverse events and serious adverse events in the Multikine arms was not substantially different versus the SOC.</em></td></tr></table></p> <p style="margin:0px"></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">The pivotal Phase 3 trial is intended to support a Biologics Licensing Application to FDA, which has not yet been submitted. FDA is the only U.S. entity authorized to determine safety and efficacy. Multikine is currently not FDA approved. </p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"><strong>Vienna, VA, August 19, 2022 &#8212; </strong>CEL-SCI Corporation <strong>(NYSE American: CVM)</strong> announced today that the results of its 10-year IT-MATTERS pivotal Phase 3 clinical trial in head and neck cancer with its investigational immunotherapy Multikine&#174;* (Leukocyte Interleukin, Injection) have been posted on clinicaltrials.gov per U.S. government requirements. (<em>See </em><em><u>https://clinicaltrials.gov/ct2/show/results/NCT01265849?term=multikine&amp;draw=2&amp;rank=2</u></em>). Clinicaltrials.gov is the largest clinical trial database in the world. It is run by the U.S. National Library of Medicine at the National Institutes of Health. Some of the trial&#8217;s results were published in two peer-reviewed abstracts and a poster at the ASCO conference in June 2022. (<em>See </em><u>https://www.businesswire.com/news/home/20220527005092/en/</u>.) Additional results will be published in scientific journals and presented in scientific forums in the future.</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"><strong>Design of IT-MATTERS Phase 3 Trial</strong></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;">The 928-patient IT-MATTERS study was designed to determine if Multikine provided survival and other clinical benefits to patients suffering from locally advanced primary squamous cell carcinoma of the head and neck (SCCHN), oral cavity and soft-palate. Multikine is a<strong>&nbsp;mixture of naturally occurring cytokines</strong> that regulate the immune system. Multikine is the first investigational cancer immunotherapy being developed as a first-line neo-adjuvant treatment to be provided to <em><u>previously untreated</u></em> locally advanced primary disease SCCHN patients <em><u>before</u></em> they receive the SOC. The global IT-MATTERS trial was conducted in 23 countries in accordance with Good Clinical Practices, International Counsel for Harmonization standards, and all other country-specific regulatory requirements. </p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="margin:0px"> <table style="border-spacing:0;font:10pt times new roman;width:100%" cellpadding="0"> <tr style="height:15px"> <td class="hpbhr">&nbsp;</td></tr> <tr style="height:15px"> <td style="BORDER-BOTTOM: black 1px solid; TEXT-INDENT: 0px;text-align:center;">2</td></tr> <tr style="height:15px"> <td><p style='page-break-after: always'></p></td></tr> <tr style="height:15px"> <td>&nbsp;</td></tr></table></p> <p style="margin:0px"></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;">Following diagnosis, subjects were randomized into one of three treatment arms. In the primary treatment arm (3/7) subjects received three consecutive weeks of treatment with supraphysiologic doses of Multikine injected 5x/wk peritumorally and perilymphatically plus &#8220;CIZ&#8221; prior to receiving the SOC. (CIZ comprised&nbsp;a non-chemotherapeutic dose&nbsp; of cyclophosphamide (administered one-time only IV-bolus, 3 days prior to the 1<sup style="vertical-align:super">st</sup> dose of Multikine), and indomethacin and zinc-multivitamins daily from day 1 of Multikine administration to one day before surgery to enhance Multikine activity.) In the second arm (1/7), subjects received the three-week Multikine regimen without CIZ prior to receiving the SOC. In the third arm (3/7), which was study control arm, subjects received only the SOC (with no Multikine or CIZ). Thus, all subjects in the study received the SOC, but some subjects received Multikine before the SOC (the two study treatment arms) and some did not (study control arm). The two main comparator groups in the study were the primary arm (Multikine+CIZ+SOC) and the study control arm (SOC alone).</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;">The SOC for all research subjects was identical and involved a bifurcated treatment path following surgery, i.e., a radiotherapy-only arm and a concurrent chemoradiotherapy arm. To determine which path a patient should take, the treating physicians decided after surgery based on pathology and medical judgment, as guided by the National Comprehensive Cancer Network (NCCN) Guidelines, whether the patient was at a higher risk for tumor recurrence. These patients would receive concurrent chemoradiotherapy. All other patients were classified as lower risk for recurrence and would receive only radiotherapy after surgery. </p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;">The &#8220;Proposed Indication&#8221; for Multikine will be limited by certain eligibility criteria to select patients deemed by NCCN Guidelines for the lower-risk-for-recurrence group. Patients would not meet the eligibility criteria if they present with adverse features that would place them in the higher-risk-for-recurrence group per NCCN Guidelines. Note that the term &#8220;lower risk for recurrence&#8221; should not be confused with a low risk of death, because the 5-year survival for such patients is still less than 50%, even after receiving the current SOC.</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;">It must also be noted that the bifurcated treatment path described above was not created by CEL-SCI for its study but was, and still is, the SOC per NCCN Guidelines for advanced primary SCCHN patients. Because it would have been unethical to deprive any subjects of the SOC, the only ethical way to have conducted the study was to use the bifurcated SOC following surgery&#8212;it would not have been ethically permissible to study Multikine in only one treatment arm at a time (lower-risk or higher-risk only). Furthermore, because it was obvious when the study was designed that Multikine might provide a benefit in only one of the two SOC risk groups, CEL-SCI pre-specified<em> </em>in its original study protocol that analyses of the trial results should take place for all, as well as for each of these groups. Separate analyses of the lower-risk-for-recurrence and higher-risk-for-recurrence treatment arms were also pre-specified in the study&#8217;s statistical analysis plan which was completed before data lock and the study result were analyzed.&nbsp; </p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;">About 40% of study subjects (n=380) were classified and met the NCCN requirements for having a lower risk of tumor recurrence, and it was in this arm of the study that the vast majority of the objective responders discussed above were observed. It was also observed in this arm that Multikine+CIZ-treated non-responders still saw OS benefit. Thus, when the lower-risk-for-recurrence arm was viewed as a whole (responders plus non-responders together), a statistically significant OS benefit from Multikine was observed overall, which provided <em><u>a nearly four-year extension of median survival time versus the control</u></em>.</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="margin:0px"> <table style="border-spacing:0;font:10pt times new roman;width:100%" cellpadding="0"> <tr style="height:15px"> <td class="hpbhr">&nbsp;</td></tr> <tr style="height:15px"> <td style="BORDER-BOTTOM: black 1px solid; TEXT-INDENT: 0px;text-align:center;">3</td></tr> <tr style="height:15px"> <td><p style='page-break-after: always'></p></td></tr> <tr style="height:15px"> <td>&nbsp;</td></tr></table></p> <p style="margin:0px"></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;">Using data from the study, CEL-SCI developed eligibility criteria to select, prior to surgery, the patients who would be slated for classification by the NCCN Guidelines as lower-risk-for-recurrence. This distinction currently can be determined only after surgery. Based on the ability to select subjects before surgery who should receive the Multikine treatment, CEL-SCI plans to seek FDA approval for the treatment of locally advanced primary disease SCCHN subjects who would receive Multikine first, then receive surgery, and then receive only radiotherapy, per NCCN Guidelines. </p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;">The Proposed Indication represents about 210,000 patients worldwide per year. To CEL-SCI&#8217;s knowledge the last medical advance for such patients impacting their overall survival occurred when Methotrexate was approved over 60 years ago. Multikine also received FDA Orphan Drug Designation for the &#8220;neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck (SCCHN).&#8221; There is thus a clear unmet medical need for improved treatments for these patients.</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;"><strong>IT-MATTERS Phase 3 Trial Results Summary</strong></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">This release summarizes the results recently posted on <em>clinicaltrials.gov</em> for the overall ITT population as well as the subjects constituting the Proposed Indication representing 41.2% of the study overall ITT population.&nbsp; (<em>See </em><u><em>https://clinicaltrials.gov/ct2/show/results/NCT01265849?term=multikine&amp;draw=2&amp;rank=2</em>) </u>Please refer to the clinicaltrials.gov presentation of the data for further information on study design and study data.&nbsp; </p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="margin:0px"> <table style="border-spacing:0;text-align:left;font:10pt times new roman;width:100%" cellpadding="0"> <tr style="height:15px"> <td style="width:4%;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="width:4%;vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><font style="font-family:symbol">&#183;</font></p></td> <td style="vertical-align:top;"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"><em><u>Objective Responses Before Surgery (partial and complete tumor response per RECIST, confirmed at surgery by pathology)</u></em>: In the overall ITT population, objective responses before surgery (sometimes also called &#8220;early responses&#8221;) were observed in 45 subjects who received Multikine for 3 weeks; no such responses were observed in the SOC alone (control) (p&lt;0.00000001).</p></td></tr></table></p> <p style="margin:0px"></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="margin:0px"> <table style="border-spacing:0;text-align:left;font:10pt times new roman;width:100%" cellpadding="0"> <tr style="height:15px"> <td style="width:12%;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="width:4%;vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">o</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">Five subjects who received Multikine+CIZ had complete tumor responses confirmed at surgery.</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">o</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">In the overall ITT population (n=923), objective responses were seen in:</p></td></tr></table></p> <p style="margin:0px"></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="margin:0px"> <table style="border-spacing:0;text-align:left;font:10pt times new roman;width:100%" cellpadding="0"> <tr style="height:15px"> <td style="width:20%;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="width:4%;vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><font style="font-family:symbol">&#183;</font></p></td> <td style="vertical-align:top;">8.5% of Multikine-treated subjects (45/529).</td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><font style="font-family:symbol">&#183;</font></p></td> <td style="vertical-align:top;">8.1% of the Multikine+CIZ treatment arm (32/395).</td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><font style="font-family:symbol">&#183;</font></p></td> <td style="vertical-align:top;">9.7% of the Multikine without CIZ treatment arm (13/134);</td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><font style="font-family:symbol">&#183;</font></p></td> <td style="vertical-align:top;">0% of the SOC alone (control) treatment arm (0/394).</td></tr></table></p> <p style="margin:0px"></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp; </p> <p style="margin:0px"> <table style="border-spacing:0;text-align:left;font:10pt times new roman;width:100%" cellpadding="0"> <tr style="height:15px"> <td style="width:12%;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="width:4%;vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">o</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">In the Proposed Indication (n=380), objective responses were seen in:</p></td></tr></table></p> <p style="margin:0px"></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="margin:0px"> <table style="border-spacing:0;text-align:left;font:10pt times new roman;width:100%" cellpadding="0"> <tr style="height:15px"> <td style="width:20%;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="width:4%;vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><font style="font-family:symbol">&#183;</font></p></td> <td style="vertical-align:top;">16.0% of Multikine-treated subjects (34/212).</td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><font style="font-family:symbol">&#183;</font></p></td> <td style="vertical-align:top;">15.2% of the Multikine+CIZ treatment arm (24/158).</td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><font style="font-family:symbol">&#183;</font></p></td> <td style="vertical-align:top;">18.5% of the Multikine without CIZ treatment arm (10/54); and</td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><font style="font-family:symbol">&#183;</font></p></td> <td style="vertical-align:top;">0% of the SOC alone (control) treatment arm (0/168).</td></tr></table></p> <p style="margin:0px"></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="margin:0px"> <table style="border-spacing:0;font:10pt times new roman;width:100%" cellpadding="0"> <tr style="height:15px"> <td class="hpbhr">&nbsp;</td></tr> <tr style="height:15px"> <td style="BORDER-BOTTOM: black 1px solid; TEXT-INDENT: 0px;text-align:center;">4</td></tr> <tr style="height:15px"> <td><p style='page-break-after: always'></p></td></tr> <tr style="height:15px"> <td>&nbsp;</td></tr></table></p> <p style="margin:0px"></p> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p> <p style="margin:0px"> <table style="border-spacing:0;text-align:left;font:10pt times new roman;width:100%" cellpadding="0"> <tr style="height:15px"> <td style="width:4%;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="width:4%;vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><font style="font-family:symbol">&#183;</font></p></td> <td style="vertical-align:top;"><em><u>Objective Responses Before Surgery Were Prognostic For Survival</u></em><u><em>with a Significant Decrease in Death Rate:</em></u></td></tr></table></p> <p style="margin:0px"></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="margin:0px"> <table style="border-spacing:0;text-align:left;font:10pt times new roman;width:100%" cellpadding="0"> <tr style="height:15px"> <td style="width:12%;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="width:4%;vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">o</p></td> <td style="vertical-align:top;"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">In the overall ITT population (n=923), the 22.2% death rate among Multikine objective responders before surgery (n=45) was significantly lower (two-sided Fisher Exact test p&lt;0.0001; HR=0.301) than the 54.1% death rate for the remaining Multikine non-responders (n=484);</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">o</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">In the Proposed Indication (n=380):</p></td></tr></table></p> <p style="margin:0px"></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="margin:0px"> <table style="border-spacing:0;text-align:left;font:10pt times new roman;width:100%" cellpadding="0"> <tr style="height:15px"> <td style="width:20%;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="width:4%;vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><font style="font-family:symbol">&#183;</font></p></td> <td style="vertical-align:top;"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">the 17.6% death rate among all Multikine objective responders before surgery (n=34) was significantly lower (two-sided Fisher Exact test p=0.0067; HR=0.348) than the 42.7% death rate for the remaining Multikine non-responders (n=178).</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><font style="font-family:symbol">&#183;</font></p></td> <td style="vertical-align:top;"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">the 12.5% death rate among Multikine+CIZ objective responders before surgery (n=24) was significantly lower (two-sided Fisher Exact test p=0.0101; HR=0.246) than the 41.0% death rate for the remaining Multikine non-responders (n=134).</p></td></tr></table></p> <p style="margin:0px"></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="margin:0px"> <table style="border-spacing:0;text-align:left;font:10pt times new roman;width:100%" cellpadding="0"> <tr style="height:15px"> <td style="width:4%;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="width:4%;vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><font style="font-family:symbol">&#183;</font></p></td> <td style="vertical-align:top;"><em><u>Significant OS advantage in the Proposed Indication</u></em> for the Multikine+CIZ treatment arm versus the SOC control:</td></tr></table></p> <p style="margin:0px"></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="margin:0px"> <table style="border-spacing:0;text-align:left;font:10pt times new roman;width:100%" cellpadding="0"> <tr style="height:15px"> <td style="width:12%;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="width:4%;vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">o</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">5-year absolute OS advantage of 14.1% (62.7% vs 48.6%);</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">o</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">proportional hazards two-sided p=0.0236;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">o</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">0.68 hazard ratio equating to a 47% OS prolongation; and</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">o</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">3-year and 4-year absolute OS advantage of 4.9% and 9.5%, respectively, are supportive.</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">o</p></td> <td style="vertical-align:top;"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">In the overall ITT population, no statistically significant OS difference was seen between the two main comparator groups (proportional hazards two-sided p=0.4128). It is believed that the higher-risk-for-recurrence patients in the overall ITT were too sick to tolerate the extra three-weeks before surgery for the Multikine treatment and also that chemotherapy may impair Multikine&#8217;s immunological mechanism of action.</p></td></tr></table></p> <p style="margin:0px"></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="margin:0px"> <table style="border-spacing:0;text-align:left;font:10pt times new roman;width:100%" cellpadding="0"> <tr style="height:15px"> <td style="width:4%;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="width:4%;vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><font style="font-family:symbol">&#183;</font></p></td> <td style="vertical-align:top;"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"><em><u>Nearly Four-Year Median OS Benefit</u></em>: In the Proposed Indication, the median OS for those receiving Multikine+CIZ was 101.7 months versus 55.2 months for the control, a survival improvement of almost four years. The Multikine treatment arm without CIZ in the Proposed Indication also had better median OS than control (68.2 months vs. 55.2 months).</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><font style="font-family:symbol">&#183;</font></p></td> <td style="vertical-align:top;"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"><em><u>Progression-Free Survival (PFS)</u></em>: In the Proposed Indication, there was confirmatory PFS difference between the two main comparator groups (HR=0.76; proportional hazards two-sided p=0.0896). In the overall ITT population, there was no statistically significant PFS difference between the two main comparator groups (proportional hazards two-sided p=0.3728).</p></td></tr></table></p> <p style="margin:0px"></p> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp; </p> <p style="margin:0px"> <table style="border-spacing:0;font:10pt times new roman;width:100%" cellpadding="0"> <tr style="height:15px"> <td class="hpbhr">&nbsp;</td></tr> <tr style="height:15px"> <td style="BORDER-BOTTOM: black 1px solid; TEXT-INDENT: 0px;text-align:center;">5</td></tr> <tr style="height:15px"> <td><p style='page-break-after: always'></p></td></tr> <tr style="height:15px"> <td>&nbsp;</td></tr></table></p> <p style="margin:0px"></p> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p> <p style="margin:0px"> <table style="border-spacing:0;text-align:left;font:10pt times new roman;width:100%" cellpadding="0"> <tr style="height:15px"> <td style="width:4%;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="width:4%;vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><font style="font-family:symbol">&#183;</font></p></td> <td style="vertical-align:top;"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"><em><u>Locoregional Control (LRC)</u></em>: In the Proposed Indication, there was no statistically significant LRC difference between the two main study groups (proportional hazards two-sided p=0.4082). In the overall ITT population, there was no statistically significant LRC difference between the two main comparator groups (proportional hazards two-sided p=0.8020).</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><font style="font-family:symbol">&#183;</font></p></td> <td style="vertical-align:top;"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"><em><u>Significant Histopathological Results</u></em>: OS, PFS, and LRC were examined using a proportional hazards model to assess the interactions between histopathology (HP) cellular marker expression levels, risk group (lower and higher), and treatment in the two main comparator groups. Twenty HP markers were classified as low, medium, and high. Two HP ratios were classified as low, medium, and high. Fourteen HP combinations were classified as low and high. These resulted in 94 possible comparisons for each of OS, PFS, and LRC. Significance favoring Multikine+CIZ vs. control (two-sided p&lt;0.05) was observed in the Proposed Indication as follows:</p></td></tr></table></p> <p style="margin:0px"></p> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp; </p> <p style="margin:0px"> <table style="border-spacing:0;text-align:left;font:10pt times new roman;width:100%" cellpadding="0"> <tr style="height:15px"> <td style="width:12%;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="width:4%;vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">o</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">OS: 14 markers, 2 ratios, and 9 combinations;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">o</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">PFS: 11 markers, 1 ratio, and 5 combinations;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">o</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">LRC: 9 markers, 1 ratio, and 6 combinations;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">o</p></td> <td style="vertical-align:top;"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">Combined (summed across endpoints), significance was reached for 21.6% (61/282) of the total possible comparisons, and the one-sided 97.5% confidence bound on the fraction significance was 16.3% which exceeds 5% chance alone.</p></td></tr></table></p> <p style="margin:0px"></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="margin:0px"> <table style="border-spacing:0;text-align:left;font:10pt times new roman;width:100%" cellpadding="0"> <tr style="height:15px"> <td style="width:4%;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="width:4%;vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px"><font style="font-family:symbol">&#183;</font></p></td> <td style="vertical-align:top;"><em><u>No excess safety issues:</u></em></td></tr></table></p> <p style="margin:0px"></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="margin:0px"> <table style="border-spacing:0;text-align:left;font:10pt times new roman;width:100%" cellpadding="0"> <tr style="height:15px"> <td style="width:12%;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="width:4%;vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">o</p></td> <td style="vertical-align:top;"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">The overall adverse event rates were 92.4% for the Multikine+CIZ treatment arm; 95.9% for the treatment arm receiving Multikine without CIZ, and 96.1% for the SOC alone (control) treatment arm.</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">o</p></td> <td style="vertical-align:top;"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">The overall serious adverse event rates were 53% for the Multikine+CIZ treatment arm, 50.7% for the treatment arm receiving Multikine without CIZ, and 52.7% for the SOC alone (control) treatment arm.</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px;text-indent:30px">&nbsp;</p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td></tr> <tr style="height:15px"> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">o</p></td> <td style="vertical-align:top;"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">The incidence of adverse events and serious adverse events noted in the Multikine arms was not substantially different from those in control.</p></td></tr></table></p> <p style="margin:0px"></p> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp; </p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"><strong>Importance of Multikine&#8217;s IT-MATTERS Trial Results</strong></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;">Head and neck carcinomas constitute about 890,000 cases annually worldwide. In the United States, there are about 68,000 new cases annually. Of those, 90% are squamous cell carcinomas, and approximately two-thirds of these patients present on their first visit with locally advanced primary (untreated) disease. Currently, the median 3-year OS with the existing SOC is estimated at 55%. The 5-year OS is approximately 43%. There are clearly many locally advanced primary SCCHN patients who are not well served by the currently available treatment modalities.</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;">The IT-MATTERS trial confirms that a 3-week treatment with Multikine provides objective responses before surgery with statistically significant five-year OS benefit for the Proposed Indication, <em>i.e.</em>, patients deemed by the NCCN Guidelines as lower risk of recurrence and who should receive radiotherapy without chemotherapy following surgery. </p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="margin:0px"> <table style="border-spacing:0;font:10pt times new roman;width:100%" cellpadding="0"> <tr style="height:15px"> <td class="hpbhr">&nbsp;</td></tr> <tr style="height:15px"> <td style="BORDER-BOTTOM: black 1px solid; TEXT-INDENT: 0px;text-align:center;">6</td></tr> <tr style="height:15px"> <td><p style='page-break-after: always'></p></td></tr> <tr style="height:15px"> <td>&nbsp;</td></tr></table></p> <p style="margin:0px"></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;">Multikine administration (+/- CIZ), as the first therapy after diagnosis, demonstrated objective complete and partial responses before surgery in 8.5% of the overall ITT population and in 16.0% of all Multikine-treated patients (+/- CIZ) in the lower-risk-for-recurrence treatment arm. A partial response means that the tumor has been reduced by at least 30%, and a complete response means that the tumor has completely disappeared. These objective tumor responses were noted within three-weeks of the beginning of Multikine treatment up to surgery and provided direct evidence of Multikine&#8217;s anticancer activity. </p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;">Although objective responses to cancer drugs do not always lead to improved survival, in the case of Multikine, objective responses resulted in a significantly reduced death rate. For Multikine+CIZ patients in the Proposed Indication, the death rate fell from 41% for non-responders to 12.5% for objective responders. A similar effect was also seen for objective responders in the overall ITT as well. </p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;">These reduced death rates yielded an absolute OS advantage of 14.1% at 5-years versus the SOC alone in the lower-risk-for-recurrence treatment arm, with a proportional hazard p-value of 0.0236, a hazard ratio of 0.68 (representing 47% prolongation of survival), a median overall survival that is nearly 4-years longer than from the SOC alone, confirmatory PFS benefit, and histopathological data showing the direct effect of the Multikine treatment on the tumor and the tumor microenvironment. </p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;">These statistics mean that for every 100 patients who would receive Multikine (if approved) followed by surgery and radiotherapy only, the likelihood is that about 14 more people would be alive at 5-years compared to the existing SOC. Since about 210,000 advanced primary SCCHN patients globally would be eligible for this treatment, the OS advantage seen in this study could mean that about 29,000 more people would be alive at 5-years post-therapy versus the SOC if all these patients received the Multikine+CIZ treatment regimen followed by surgery and radiotherapy.</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;">By contrast, the SOC control group did not see <em><u>any</u></em> objective responses before surgery. CEL-SCI is unaware of any existing therapy that provides complete or partial tumor responses within three-weeks of treatment before surgery for locally advanced primary SCCHN, much less objective responses before surgery that are prognostic/predictive of longer survival, as reached in this study. </p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;">It must be noted that Multikine is different from existing therapies. Multikine is designed to be administered locally first, immediately following diagnosis, to <em><u>previously untreated</u></em> patients whose tumors and any involved lymph nodes are slated for surgical resection with &#8220;intent-to-cure&#8221; SOC.&nbsp; To the company&#8217;s knowledge, there has been no such therapy or neoadjuvant approved by FDA in at least several decades for resectable locally advanced primary SCCHN. Although existing checkpoint inhibitor drug therapies (like Keytruda) have been approved and marketed as &#8220;first-line&#8221; treatments for head and neck cancer, their indications are limited to the first-line treatment of recurrent or non-resectable tumors. By contrast, Multikine&#8217;s Proposed Indication would be for previously untreated, locally advanced primary SCCHN patients scheduled for surgery and radiation without chemotherapy, encompassing about 40% of the entire advanced primary SCCHN population.</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;">These Phase 3 trial results are intended to support a Biologics Licensing Application to FDA, which has not yet been submitted. FDA is the only U.S. entity authorized to determine safety and efficacy, and Multikine is currently not approved.</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="margin:0px"> <table style="border-spacing:0;font:10pt times new roman;width:100%" cellpadding="0"> <tr style="height:15px"> <td class="hpbhr">&nbsp;</td></tr> <tr style="height:15px"> <td style="BORDER-BOTTOM: black 1px solid; TEXT-INDENT: 0px;text-align:center;">7</td></tr> <tr style="height:15px"> <td><p style='page-break-after: always'></p></td></tr> <tr style="height:15px"> <td>&nbsp;</td></tr></table></p> <p style="margin:0px"></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"><strong>About CEL-SCI Corporation</strong> </p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">CEL-SCI believes that boosting a patient&#8217;s immune system while it is still intact should provide the greatest possible impact on survival. Therefore, in the Phase 3 study, CEL-SCI treated subjects who were newly diagnosed with advanced primary squamous cell carcinoma of the head and neck with the investigational product Multikine first, <em><u>before</u></em> they received surgery and radiotherapy, or surgery plus concurrent radiotherapy and chemotherapy (the current standard of care for these patients). This approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine (Leukocyte Interleukin, Injection) received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. CEL-SCI believes that this study is the largest Phase 3 study in the world for the treatment of advanced primary head and neck cancer.</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">Multikine is designed to help the immune system &#8220;see&#8221; the tumor at a time when the immune system is still relatively intact and, thereby, thought to be better able to mount an attack on the tumor. The Phase 3 study was started in early 2011 and was fully enrolled with 928 subjects in September 2016.&nbsp; To prove an overall survival benefit, the study required CEL-SCI to wait until at least 298 (deaths) events had occurred among the two main comparator groups. </p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">The Company has operations in Vienna, Virginia, and in Baltimore, Maryland.</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"><strong>Forward-Looking Statements</strong></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;">This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. 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's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2021. 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.</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"><em>* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.</em></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;"><strong>Contacts</strong></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">COMPANY CONTACT:</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">Gavin de Windt</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">CEL-SCI Corporation</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">(703) 506-9460</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p> <p style="margin:0px"> <table style="border-spacing:0;font:10pt times new roman;width:100%" cellpadding="0"> <tr style="height:15px"> <td class="hpbhr">&nbsp;</td></tr> <tr style="height:15px"> <td style="BORDER-BOTTOM: black 1px solid; TEXT-INDENT: 0px;text-align:center;">8</td></tr></table></p> <p style="margin:0px"></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">&nbsp;</p><body>
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  <link:roleRef xlink:type="simple" xlink:href="http://www.xbrl.org/lrr/role/negated-2009-12-16.xsd#negatedPeriodStartLabel" roleURI="http://www.xbrl.org/2009/role/negatedPeriodStartLabel" />
  <link:roleRef xlink:type="simple" xlink:href="http://www.xbrl.org/lrr/role/negated-2009-12-16.xsd#negatedTotalLabel" roleURI="http://www.xbrl.org/2009/role/negatedTotalLabel" />
  <link:roleRef xlink:type="simple" xlink:href="http://www.xbrl.org/lrr/role/negated-2009-12-16.xsd#negatedNetLabel" roleURI="http://www.xbrl.org/2009/role/negatedNetLabel" />
  <link:roleRef xlink:type="simple" xlink:href="http://www.xbrl.org/lrr/role/negated-2009-12-16.xsd#negatedTerseLabel" roleURI="http://www.xbrl.org/2009/role/negatedTerseLabel" />
  <link:roleRef xlink:type="simple" xlink:href="http://www.xbrl.org/lrr/role/net-2009-12-16.xsd#netLabel" roleURI="http://www.xbrl.org/2009/role/netLabel" />
  <link:labelLink xlink:type="extended" xlink:role="http://www.xbrl.org/2003/role/link">
    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_CoverAbstract" xlink:label="dei_CoverAbstract" />
    <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_CoverAbstract" xlink:to="dei_CoverAbstract_lbl" xlink:type="arc" />
    <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_CoverAbstract_lbl" xml:lang="en-US">Cover [Abstract]</link:label>
    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_EntityRegistrantName" xlink:label="dei_EntityRegistrantName" />
    <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_EntityRegistrantName" xlink:to="dei_EntityRegistrantName_lbl" xlink:type="arc" />
    <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_EntityRegistrantName_lbl" xml:lang="en-US">Entity Registrant Name</link:label>
    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_EntityCentralIndexKey" xlink:label="dei_EntityCentralIndexKey" />
    <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_EntityCentralIndexKey" xlink:to="dei_EntityCentralIndexKey_lbl" xlink:type="arc" />
    <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_EntityCentralIndexKey_lbl" xml:lang="en-US">Entity Central Index Key</link:label>
    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_DocumentType" xlink:label="dei_DocumentType" />
    <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_DocumentType" xlink:to="dei_DocumentType_lbl" xlink:type="arc" />
    <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_DocumentType_lbl" xml:lang="en-US">Document Type</link:label>
    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_AmendmentFlag" xlink:label="dei_AmendmentFlag" />
    <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_AmendmentFlag" xlink:to="dei_AmendmentFlag_lbl" xlink:type="arc" />
    <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_AmendmentFlag_lbl" xml:lang="en-US">Amendment Flag</link:label>
    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_EntityEmergingGrowthCompany" xlink:label="dei_EntityEmergingGrowthCompany" />
    <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_EntityEmergingGrowthCompany" xlink:to="dei_EntityEmergingGrowthCompany_lbl" xlink:type="arc" />
    <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_EntityEmergingGrowthCompany_lbl" xml:lang="en-US">Entity Emerging Growth Company</link:label>
    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_DocumentPeriodEndDate" xlink:label="dei_DocumentPeriodEndDate" />
    <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_DocumentPeriodEndDate" xlink:to="dei_DocumentPeriodEndDate_lbl" xlink:type="arc" />
    <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_DocumentPeriodEndDate_lbl" xml:lang="en-US">Document Period End Date</link:label>
    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_EntityIncorporationStateCountryCode" xlink:label="dei_EntityIncorporationStateCountryCode" />
    <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_EntityIncorporationStateCountryCode" xlink:to="dei_EntityIncorporationStateCountryCode_lbl" xlink:type="arc" />
    <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_EntityIncorporationStateCountryCode_lbl" xml:lang="en-US">Entity Incorporation State Country Code</link:label>
    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_EntityTaxIdentificationNumber" xlink:label="dei_EntityTaxIdentificationNumber" />
    <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_EntityTaxIdentificationNumber" xlink:to="dei_EntityTaxIdentificationNumber_lbl" xlink:type="arc" />
    <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_EntityTaxIdentificationNumber_lbl" xml:lang="en-US">Entity Tax Identification Number</link:label>
    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_WrittenCommunications" xlink:label="dei_WrittenCommunications" />
    <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_WrittenCommunications" xlink:to="dei_WrittenCommunications_lbl" xlink:type="arc" />
    <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_WrittenCommunications_lbl" xml:lang="en-US">Written Communications</link:label>
    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_SolicitingMaterial" xlink:label="dei_SolicitingMaterial" />
    <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_SolicitingMaterial" xlink:to="dei_SolicitingMaterial_lbl" xlink:type="arc" />
    <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_SolicitingMaterial_lbl" xml:lang="en-US">Soliciting Material</link:label>
    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_PreCommencementTenderOffer" xlink:label="dei_PreCommencementTenderOffer" />
    <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_PreCommencementTenderOffer" xlink:to="dei_PreCommencementTenderOffer_lbl" xlink:type="arc" />
    <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_PreCommencementTenderOffer_lbl" xml:lang="en-US">Pre Commencement Tender Offer</link:label>
    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_PreCommencementIssuerTenderOffer" xlink:label="dei_PreCommencementIssuerTenderOffer" />
    <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_PreCommencementIssuerTenderOffer" xlink:to="dei_PreCommencementIssuerTenderOffer_lbl" xlink:type="arc" />
    <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_PreCommencementIssuerTenderOffer_lbl" xml:lang="en-US">Pre Commencement Issuer Tender Offer</link:label>
    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_EntityFileNumber" xlink:label="dei_EntityFileNumber" />
    <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_EntityFileNumber" xlink:to="dei_EntityFileNumber_lbl" xlink:type="arc" />
    <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_EntityFileNumber_lbl" xml:lang="en-US">Entity File Number</link:label>
    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_EntityAddressAddressLine1" xlink:label="dei_EntityAddressAddressLine1" />
    <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_EntityAddressAddressLine1" xlink:to="dei_EntityAddressAddressLine1_lbl" xlink:type="arc" />
    <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_EntityAddressAddressLine1_lbl" xml:lang="en-US">Entity Address Address Line 1</link:label>
    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_EntityAddressCityOrTown" xlink:label="dei_EntityAddressCityOrTown" />
    <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_EntityAddressCityOrTown" xlink:to="dei_EntityAddressCityOrTown_lbl" xlink:type="arc" />
    <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_EntityAddressCityOrTown_lbl" xml:lang="en-US">Entity Address City Or Town</link:label>
    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_EntityAddressStateOrProvince" xlink:label="dei_EntityAddressStateOrProvince" />
    <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_EntityAddressStateOrProvince" xlink:to="dei_EntityAddressStateOrProvince_lbl" xlink:type="arc" />
    <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_EntityAddressStateOrProvince_lbl" xml:lang="en-US">Entity Address State Or Province</link:label>
    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_CityAreaCode" xlink:label="dei_CityAreaCode" />
    <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_CityAreaCode" xlink:to="dei_CityAreaCode_lbl" xlink:type="arc" />
    <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_CityAreaCode_lbl" xml:lang="en-US">City Area Code</link:label>
    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_LocalPhoneNumber" xlink:label="dei_LocalPhoneNumber" />
    <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_LocalPhoneNumber" xlink:to="dei_LocalPhoneNumber_lbl" xlink:type="arc" />
    <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_LocalPhoneNumber_lbl" xml:lang="en-US">Local Phone Number</link:label>
    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_Security12bTitle" xlink:label="dei_Security12bTitle" />
    <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_Security12bTitle" xlink:to="dei_Security12bTitle_lbl" xlink:type="arc" />
    <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_Security12bTitle_lbl" xml:lang="en-US">Security 12b Title</link:label>
    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_TradingSymbol" xlink:label="dei_TradingSymbol" />
    <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_TradingSymbol" xlink:to="dei_TradingSymbol_lbl" xlink:type="arc" />
    <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_TradingSymbol_lbl" xml:lang="en-US">Trading Symbol</link:label>
    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_SecurityExchangeName" xlink:label="dei_SecurityExchangeName" />
    <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_SecurityExchangeName" xlink:to="dei_SecurityExchangeName_lbl" xlink:type="arc" />
    <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_SecurityExchangeName_lbl" xml:lang="en-US">Security Exchange Name</link:label>
    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_EntityAddressPostalZipCode" xlink:label="dei_EntityAddressPostalZipCode" />
    <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_EntityAddressPostalZipCode" xlink:to="dei_EntityAddressPostalZipCode_lbl" xlink:type="arc" />
    <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_EntityAddressPostalZipCode_lbl" xml:lang="en-US">Entity Address Postal Zip Code</link:label>
  </link:labelLink>
</link:linkbase>
</XBRL>
</TEXT>
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<DOCUMENT>
<TYPE>EX-101.CAL
<SEQUENCE>5
<FILENAME>cvm-20220819_cal.xml
<DESCRIPTION>XBRL TAXONOMY EXTENSION CALCULATION LINKBASE
<TEXT>
<XBRL>
<?xml version="1.0" encoding="us-ascii" standalone="yes"?>
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<link:linkbase xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:link="http://www.xbrl.org/2003/linkbase" xsi:schemaLocation="http://www.xbrl.org/2003/linkbase http://www.xbrl.org/2003/xbrl-linkbase-2003-12-31.xsd">
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  <link:calculationLink xlink:type="extended" xlink:role="http://cvm.com/role/Cover" xlink:title="00000001 - Document - Document and Entity Information" />
</link:linkbase>
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</TEXT>
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<DOCUMENT>
<TYPE>EX-101.PRE
<SEQUENCE>6
<FILENAME>cvm-20220819_pre.xml
<DESCRIPTION>XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE
<TEXT>
<XBRL>
<?xml version="1.0" encoding="us-ascii" standalone="yes"?>
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<!--Software architectural design and coding: A'c Dharmapremananda Avt.-->
<!--Copyright (c) 2022 I-NET Business Solutions, Inc. All Rights Reserved.-->
<link:linkbase xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:link="http://www.xbrl.org/2003/linkbase" xsi:schemaLocation="http://www.xbrl.org/2003/linkbase http://www.xbrl.org/2003/xbrl-linkbase-2003-12-31.xsd">
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  <link:presentationLink xlink:type="extended" xlink:role="http://cvm.com/role/Cover" xlink:title="00000001 - Document - Cover Page Information">
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    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_EntityRegistrantName" xlink:label="loc_deiEntityRegistrantName" />
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    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_EntityCentralIndexKey" xlink:label="loc_deiEntityCentralIndexKey" />
    <link:presentationArc order="1" xlink:arcrole="http://www.xbrl.org/2003/arcrole/parent-child" xlink:from="loc_deiCoverAbstract" xlink:to="loc_deiEntityCentralIndexKey" xlink:type="arc" />
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    <link:presentationArc order="2" xlink:arcrole="http://www.xbrl.org/2003/arcrole/parent-child" xlink:from="loc_deiCoverAbstract" xlink:to="loc_deiDocumentType" xlink:type="arc" />
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    <link:presentationArc order="8" xlink:arcrole="http://www.xbrl.org/2003/arcrole/parent-child" xlink:from="loc_deiCoverAbstract" xlink:to="loc_deiWrittenCommunications" xlink:type="arc" />
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    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_PreCommencementIssuerTenderOffer" xlink:label="loc_deiPreCommencementIssuerTenderOffer" />
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    <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2022/dei-2022.xsd#dei_EntityFileNumber" xlink:label="loc_deiEntityFileNumber" />
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<span style="display: none;">v3.22.2.2</span><table class="report" border="0" cellspacing="2" id="idm140024785154080">
<tr>
<th class="tl" colspan="1" rowspan="1"><div style="width: 200px;"><strong>Cover<br></strong></div></th>
<th class="th"><div>Aug. 19, 2022</div></th>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_CoverAbstract', window );"><strong>Cover [Abstract]</strong></a></td>
<td class="text">&#160;<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityRegistrantName', window );">Entity Registrant Name</a></td>
<td class="text">CEL-SCI CORPORATION<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityCentralIndexKey', window );">Entity Central Index Key</a></td>
<td class="text">0000725363<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_DocumentType', window );">Document Type</a></td>
<td class="text">8-K<span></span>
</td>
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<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_AmendmentFlag', window );">Amendment Flag</a></td>
<td class="text">false<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityEmergingGrowthCompany', window );">Entity Emerging Growth Company</a></td>
<td class="text">false<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_DocumentPeriodEndDate', window );">Document Period End Date</a></td>
<td class="text">Aug. 19,  2022<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityIncorporationStateCountryCode', window );">Entity Incorporation State Country Code</a></td>
<td class="text">CO<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityTaxIdentificationNumber', window );">Entity Tax Identification Number</a></td>
<td class="text">84-0916344<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_WrittenCommunications', window );">Written Communications</a></td>
<td class="text">false<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_SolicitingMaterial', window );">Soliciting Material</a></td>
<td class="text">false<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_PreCommencementTenderOffer', window );">Pre Commencement Tender Offer</a></td>
<td class="text">false<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_PreCommencementIssuerTenderOffer', window );">Pre Commencement Issuer Tender Offer</a></td>
<td class="text">false<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityFileNumber', window );">Entity File Number</a></td>
<td class="text">001-11889<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityAddressAddressLine1', window );">Entity Address Address Line 1</a></td>
<td class="text">8229 Boone Blvd. #802<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityAddressCityOrTown', window );">Entity Address City Or Town</a></td>
<td class="text">Vienna<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityAddressStateOrProvince', window );">Entity Address State Or Province</a></td>
<td class="text">VA<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_CityAreaCode', window );">City Area Code</a></td>
<td class="text">703<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_LocalPhoneNumber', window );">Local Phone Number</a></td>
<td class="text">506-9460<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_Security12bTitle', window );">Security 12b Title</a></td>
<td class="text">Common Stock<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_TradingSymbol', window );">Trading Symbol</a></td>
<td class="text">CVM<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_SecurityExchangeName', window );">Security Exchange Name</a></td>
<td class="text">NYSEAMER<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityAddressPostalZipCode', window );">Entity Address Postal Zip Code</a></td>
<td class="text">22182<span></span>
</td>
</tr>
</table>
<div style="display: none;">
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_AmendmentFlag">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Boolean flag that is true when the XBRL content amends previously-filed or accepted submission.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_AmendmentFlag</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:booleanItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_CityAreaCode">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Area code of city</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_CityAreaCode</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:normalizedStringItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_CoverAbstract">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Cover page.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_CoverAbstract</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:stringItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_DocumentPeriodEndDate">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period.  The format of the date is YYYY-MM-DD.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_DocumentPeriodEndDate</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:dateItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_DocumentType">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_DocumentType</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>dei:submissionTypeItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityAddressAddressLine1">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Address Line 1 such as Attn, Building Name, Street Name</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityAddressAddressLine1</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:normalizedStringItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityAddressCityOrTown">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Name of the City or Town</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityAddressCityOrTown</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:normalizedStringItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityAddressPostalZipCode">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Code for the postal or zip code</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityAddressPostalZipCode</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:normalizedStringItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityAddressStateOrProvince">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Name of the state or province.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityAddressStateOrProvince</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>dei:stateOrProvinceItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityCentralIndexKey">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 12<br> -Subsection b-2<br></p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityCentralIndexKey</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>dei:centralIndexKeyItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityEmergingGrowthCompany">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Indicate if registrant meets the emerging growth company criteria.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 12<br> -Subsection b-2<br></p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityEmergingGrowthCompany</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:booleanItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityFileNumber">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityFileNumber</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>dei:fileNumberItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityIncorporationStateCountryCode">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Two-character EDGAR code representing the state or country of incorporation.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityIncorporationStateCountryCode</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>dei:edgarStateCountryItemType</td>
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<tr>
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<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 12<br> -Subsection b-2<br></p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
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<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 12<br> -Subsection b-2<br></p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
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<td style="white-space:nowrap;">dei_EntityTaxIdentificationNumber</td>
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<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
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<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Local phone number for entity.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
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<td style="white-space:nowrap;">dei_LocalPhoneNumber</td>
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<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_PreCommencementIssuerTenderOffer">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 13e<br> -Subsection 4c<br></p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_PreCommencementIssuerTenderOffer</td>
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<td>xbrli:booleanItemType</td>
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<td><strong> Balance Type:</strong></td>
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<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 14d<br> -Subsection 2b<br></p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_PreCommencementTenderOffer</td>
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<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Title of a 12(b) registered security.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 12<br> -Subsection b<br></p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_Security12bTitle</td>
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<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
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<td><strong> Balance Type:</strong></td>
<td>na</td>
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<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_SecurityExchangeName">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
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<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Name of the Exchange on which a security is registered.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 12<br> -Subsection d1-1<br></p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_SecurityExchangeName</td>
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<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Section 14a<br> -Number 240<br> -Subsection 12<br></p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_SolicitingMaterial</td>
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<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
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<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Trading symbol of an instrument as listed on an exchange.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
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<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Securities Act<br> -Number 230<br> -Section 425<br></p></div>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
