<SEC-DOCUMENT>0001654954-24-002764.txt : 20240307
<SEC-HEADER>0001654954-24-002764.hdr.sgml : 20240307
<ACCEPTANCE-DATETIME>20240307113342
ACCESSION NUMBER:		0001654954-24-002764
CONFORMED SUBMISSION TYPE:	DEFA14A
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20240307
DATE AS OF CHANGE:		20240307

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			CEL SCI CORP
		CENTRAL INDEX KEY:			0000725363
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		ORGANIZATION NAME:           	03 Life Sciences
		IRS NUMBER:				840916344
		STATE OF INCORPORATION:			CO
		FISCAL YEAR END:			0930

	FILING VALUES:
		FORM TYPE:		DEFA14A
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-11889
		FILM NUMBER:		24728774

	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>DEFA14A
<SEQUENCE>1
<FILENAME>cvm_def14a.htm
<DESCRIPTION>DEFA 14A
<TEXT>
<html><head><title>cvm_def14a.htm</title><!--Document created using EDGARMaster--></head><body style="TEXT-ALIGN: justify; FONT: 10pt times new roman"><p style="margin:0px"> <table style="font-size:1px;width:100%"> <tr > <td style="BORDER-BOTTOM: 5px solid;"></td></tr> <tr > <td style="BORDER-BOTTOM: 2px solid;"></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:center;"><strong>UNITED STATES</strong></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:center;"><strong>SECURITIES AND EXCHANGE COMMISSION</strong></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:center;"><strong>WASHINGTON, D.C.&nbsp;&nbsp;20549</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:center;"><strong>SCHEDULE 14A INFORMATION</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:center;"><strong>Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934</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;">Filed by the Registrant&nbsp;&nbsp; &#9746;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;">Filed by a Party other than the Registrant&nbsp;&nbsp; &#9744;</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;">Check the appropriate box:</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;">&#9744;&nbsp;&nbsp; Preliminary Proxy Statement</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;">&#9744;&nbsp;&nbsp; Confidential, For Use of the Commission Only (As Permitted by Rule 14a-6(e)(2))</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;">&#9744;&nbsp;&nbsp; Definitive Proxy Statement</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;">&#9746;&nbsp;&nbsp; Definitive Additional Materials</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;">&#9744;&nbsp;&nbsp; Soliciting Material under Rule 14a-12</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:center;">&nbsp;</p> <p style="margin:0px"> <table style="border-spacing:0;font-size:10pt;text-align:left;margin-left:auto;margin-right:auto;width:60%" 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; text-align:center;"><strong><font style="font-size:18pt">CEL-SCI CORPORATION</font></strong></p></td></tr> <tr style="height:15px"> <td> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:center;"><em>(Name of Registrant as Specified In Its Charter)</em></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 0px 0px 0in; text-align:center;">________________________________________________</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:center;"><em>(Name of Person(s) Filing Proxy Statement, if other than the Registrant)</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;">Payment of Filing Fee (Check the appropriate box):</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;">&#9746;&nbsp;&nbsp; No fee required</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;">&#9744;&nbsp;&nbsp; Fee computed on table below per Exchange Act Rules 14a-6(i)(1) and 0-11.</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">(1)</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">Title of each class of securities to which transaction applies:</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">(2)</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">Aggregate number of securities to which transaction applies:</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">(3)</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">Per unit price or other underlying value of transaction computed pursuant to Exchange Act Rule 0-11 (set forth the amount on which the filing fee is calculated and state how it was determined):</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">(4)</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">Proposed maximum aggregate value of transaction:</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">(5)</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">Total fee paid:</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;">&#9744;&nbsp;&nbsp; Fee paid previously with preliminary materials.</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;">&#9744;&nbsp;&nbsp; Check box if any part of the fee is offset as provided by Exchange Act Rule 0-11(a)(2) and identify the filing for which the offsetting fee was paid previously. Identify the previous filing by registration statement number, or the form or schedule and the date of its filing.</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">(1)</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">Amount Previously Paid:</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">(2)</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">Form, Schedule or Registration Statement No.:</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">(3)</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">Filing Party:</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">(4)</p></td> <td style="vertical-align:top;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">Date Filed:</p></td></tr></table></p> <p style="margin:0px"></p> <p style="margin:0px">&nbsp; </p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:center;"><strong>CEL-SCI CORPORATION</strong></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:center;"><strong>8229 Boone Blvd., Suite 802</strong></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:center;"><strong>Vienna, Virginia 22l82</strong></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:center;"><strong>(703) 506-9460</strong></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:center;">&nbsp;</p> <p style="margin:0px"> <table style="font-size:1px;width:100%"> <tr > <td style="BORDER-BOTTOM: 2px solid;"></td></tr> <tr > <td style="BORDER-BOTTOM: 5px solid;"></td></tr></table></p> <p style="margin:0px"></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="TEXT-INDENT: 0px;"></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="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:center;"><img src="cvm_def14aimg1.jpg"></p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:center;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:justify;">&nbsp;</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px 0px 0px 0in; text-align:left;">March 2024</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;">Dear CEL-SCI Shareholders:</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;">Last year we successfully moved our investigational Multikine<sup style="vertical-align:super">&#174;</sup> (Leukocyte Interleukin, Injection)* cancer therapy forward on the clinical, manufacturing, and regulatory fronts by overcoming several challenges as the biotechnology sector went through very difficult times. The results from our Phase 3 trial presented us with a conundrum in that we had great survival data with Multikine as a pre-surgical treatment in head and neck cancer when followed by surgery and radiotherapy only, but not when followed by surgery, radiotherapy, <u>and</u> chemotherapy. The key issue was how to determine who should be treated with Multikine, which is given before surgery, while the determination of who gets chemotherapy added to their treatment is made after surgery. We solved this issue with great success and presented the selection criteria at a major oncology conference:</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;">CEL-SCI identified the target head and neck cancer patient population for Multikine that will be the basis for the Company&#8217;s regulatory filings for marketing clearance. In October 2023, the new data were presented at the 2023 European Society for Medical Oncology (ESMO) Congress. The target population, which saw its 5-year risk of death cut in half, can be <strong><em><u>identified prior to surgery upon diagnosis with tests that physicians routinely use in cancer screenings</u></em></strong>, a key finding for Multikine, which is a neoadjuvant therapy. A summary of Multikine&#8217;s results in the target population include the following:</p></td></tr></table></p> <p style="margin:0px"></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%;"> <p style="font-size:10pt;font-family:times new roman;margin:0px">&#9675; </p></td> <td> <p style="font-size:10pt;font-family:times new roman;margin:0px"><strong><em><u>Risk of death cut in half at 5 years vs. control</u></em></strong></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">&#9675;</p></td> <td style="vertical-align:top;">73% survival for Multikine vs 45% in the control at 5 years</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;">28.6% absolute 5-year overall survival benefit versus control; statistically significant p = 0.0015 and hazard ratio = 0.35</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">&#9675; </p></td> <td style="vertical-align:top;">Tumor reduction rate &gt;13% and tumor downstaging &gt;35%</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;">Low PD-L1 tumor expression (as compared to high PD-L1 where Keytruda and Opdivo work best)</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">&#9675; </p></td> <td style="vertical-align:top;">No safety signals or toxicities vs standard of care</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 90px; text-align:justify;">Target population is an estimated 145,000 patients (global, annual) with newly diagnosed squamous cell carcinoma of the head and neck (SCCHN) who present with:</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:16%;"> <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">&#9726; </p></td> <td style="vertical-align:top;">No lymph node involvement (via PET scan)</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">&#9726;</p></td> <td style="vertical-align:top;">Low PD-L1 tumor expression (TPS&lt;10) (via biopsy).</td></tr></table></p> <p style="margin:0px"></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">&#9675;</p></td> <td style="vertical-align:top;">Physicians routinely assess these features at baseline; no extra tests needed. These features make it easy to write a label for Multikine, which is essential for drug approval.</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">&#9675;</p></td> <td style="vertical-align:top;">CEL-SCI estimates that low PD-L1 patients represent about 70% of locally advanced primary SCCHN patients.</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;">In manufacturing, a major issue was the U.S. government&#8217;s rules prioritizing companies that make COVID products to receive medical supplies. This caused delays in our work commissioning our Multikine manufacturing facility. Fortunately, we were able to finish this critical work in January 2024:</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 0px 0px 225px; text-align:justify;">CEL-SCI&#8217;s cGMP state-of-the-art dedicated manufacturing facility commissioning was completed, a significant milestone toward a planned Biologics License Application (BLA) with several regulatory agencies for approval of Multikine. The Company&#8217;s manufacturing trade secrets, capabilities, and know-how are high-value key strategic assets that are very difficult for others to replicate.</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;">Usually companies pursue only one regulator, presumably because it is a great deal of work to pursue more. Since Multikine is a unique pre-surgical cancer drug, we decided to in parallel talk to the world&#8217;s leading regulators: FDA (U.S.), EMA (Europe), MHRA (UK) and Health Canada (Canada). In our discussions so far, we have been well received, and we have been told that clinically our results are very meaningful and promising. Regulators have been responsive and willing to help us. Here is an update of what we can share with you:</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;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">&nbsp;</p> <p style="margin:0px"> <table style="border-spacing:0;text-align:justify;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;">CEL-SCI has submitted the target population data and a proposed study protocol for a confirmatory study of 212 patients to the U.S. Food and Drug Administration (FDA) in Q1 2024.</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;">Health Canada advised CEL-SCI to request advance consideration for approval under a Notice of Compliance with Conditions (NOCC) policy.</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;">The United Kingdom&#8217;s National Institute for Health and Care Excellence (NICE) selected Multikine to be evaluated as the potential new standard of care for SCCHN. NICE posted a detailed report <u>(https://www.io.nihr.ac.uk/wp-content/uploads/2023/10/5578-Multikine-with-Cyclophosphamide-Indomethacin-and-Zinc-for-Head-and-Neck-Cancer-V1.0-OCT2023-NON-CONF.pdf)</u> from the UK&#8217;s National Institute for Health and Care Research (NIHR) regarding Multikine, its clinical data, and its potential to become a better standard of care in treating newly diagnosed head and neck cancer in the UK.</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;">The European Medicines Agency&#8217;s (EMA) Paediatric Committee granted CEL-SCI a product-specific waiver of strict requirements for commercialization of cancer drugs in the European Union (EU). The waiver is a big step forward for Multikine, as it removes a major hurdle on the path towards commercialization in Europe.</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;">Meetings with the UK regulators and the EMA are expected H1 2024.</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;">New PD-L1 biomarker findings from the Phase 3 study, which have been integrated into the new target population, demonstrated that Multikine significantly increases overall survival in patients with low levels of tumor cell PD-L1 expression. This is in stark contrast to approved checkpoint inhibitors, such as Keytruda and Opdivo, which most often show longer survival in a proportion of patients with a higher level of tumor cell PD-L1 expression, suggesting a combination therapy could boost patient outcomes. CEL-SCI filed a patent for the use of Multikine in tumors expressing low levels of PD-L1.</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;">We also presented new data at a number of leading scientific conferences:</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">&#9675;</p></td> <td style="vertical-align:top;">10th European Congress on Head &amp; Neck Oncology (ECHNO) 2023</td></tr></table></p> <p style="margin:0px"></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:16%;"> <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">&#9726;</p></td> <td style="vertical-align:top;"> <p style="MARGIN: 0px; text-align:justify;">&#8220;Leukocyte Interleukin Injection (LI) immunotherapy followed by radiotherapy extends overall survival (OS) in treatment na&#239;ve locally advanced primary squamous cell carcinoma of the head &amp; neck: the IT-MATTERS Study&#8221;</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">(<u>https://cel-sci.com/wp-content/uploads/2023/07/CEL-SCI-ECHNO-Abstract-77-ePoster-FINAL.pdf</u>)</p></td></tr></table></p> <p style="margin:0px"></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">&#9675; </p></td> <td style="vertical-align:top;">European Society for Radiotherapy and Oncology (ESTRO) 2023</td></tr></table></p> <p style="margin:0px"></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:16%;"> <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">&#9726;</p></td> <td style="vertical-align:top;">&#8220;Histopathology population (HPP) confirms Multikine* [Leukocyte Interleukin Injection (LI)] treatment (Tx) outcome in na&#239;ve locally advanced primary head &amp; neck squamous cell carcinoma SCCHN)&#8221;</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">(<u>https://cel-sci.com/wp-content/uploads/2023/07/CEL-SCI-ESTRO-PO-1231-ePoster-FINAL.pdf</u>)</p></td></tr></table></p> <p style="margin:0px"></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">&#9675; </p></td> <td style="vertical-align:top;">American Head and Neck Cancer Society&#8217;s (AHNS) 11th Annual International Conference on Head and Neck Cancer 2023</td></tr></table></p> <p style="margin:0px"></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:16%;"> <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">&#9726;</p></td> <td style="vertical-align:top;"> <p style="MARGIN: 0px; text-align:justify;">&#8220;Tumor cell PD-L1 biomarker confirms Leukocyte Interleukin Injection (LI) treatment (Tx) survival outcome advantage in naive locally advanced primary head &amp; neck squamous cell carcinoma (SCCHN), the IT-MATTERS Study&#8221;</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">(<u>https://eppro02.ativ.me/web/page.php?page=IntHtml&amp;project=AHNS23&amp;id=129110</u>)</p></td></tr></table></p> <p style="margin:0px"></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">&#9675; </p></td> <td style="vertical-align:top;">European Society for Medical Oncology (ESMO) Annual Congress 2023</td></tr></table></p> <p style="margin:0px"></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:16%;"> <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">&#9726;</font></p></td> <td style="vertical-align:top;"> <p style="MARGIN: 0px; text-align:justify;">&#8220;Early response to Neoadjuvant Leukocyte Interleukin Injection (LI) immunotherapy extends overall survival (OS) in locally advanced primary squamous cell carcinoma (SCC) of the head &amp; neck (HN): the IT-MATTERS Study&#8221;</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">(<u>https://cel-sci.com/wp-content/uploads/2023/10/ESMO-2023-Poster_893P_FINAL.pdf</u>)</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;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"><strong>&nbsp;</strong></p> <p style="font-size:10pt;font-family:times new roman;margin:0px"><strong>CEL-SCI Has All The Ingredients For Approval</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;">We can identify <em><u>at diagnosis </u></em>the patients most likely to have pre-surgical responses to Multikine. The survival statistics in this target population are so good that it is hard to imagine how they could be challenged or ignored. Multikine&#8217;s safety profile is very favorable compared to other oncology agents. And, we have a manufacturing plant that can make an estimated $2 billion worth of Multikine annually.</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;"><u>CEL-SCI is ready</u>&#8212; and we believe patients and doctors are, too. A new drug for our targeted disease (previously untreated locally advanced primary resectable squamous cell carcinoma of the head and neck) has not been approved by the FDA in decades. The current standard of care provides only a 50-50 chance of living past five years. Large companies have tried and failed to improve this figure. Patients desperately need better treatments.</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;">We now have the ingredients for delivering results to investors as well. While the biotech stock market always has its ups and downs, <strong><em><u>the clinical data will stand firm and drive the final success for CEL-SCI.</u></em></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 plans to seek approval for immediate patient access to Multikine <strong><em><u>without waiting on the results of a new trial wherever possible</u></em></strong>. There are regulatory pathways specifically designed for such approvals that CEL-SCI is pursuing worldwide. These pathways are called &#8220;conditional approvals&#8221; (or, in the U.S., accelerated approval) which means you can be approved first while a confirmatory study is ongoing and before that study is completed. Our situation&#8212;where we have selected a portion of the Phase 3 study for our target population&#8212;is precisely why these regulatory pathways were adopted by regulatory bodies, so that patients do not need to wait many years before gaining access to promising drugs that have already been shown to provide clinical benefit.</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;">Thank you for your continued support.</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;">Sincerely,</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;">Geert Kersten</p> <p style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman; MARGIN: 0px; text-align:justify;">Chief Executive Officer</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; 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, 2023. 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 0px 0px 0in; 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="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></table></p> <p style="margin:0px"></p> <p style="font-size:10pt;font-family:times new roman;margin:0px">&nbsp;</p><body>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
