10-K/A

FORM 10-K/A

(Amendment No.1)

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

(Mark One)

(X)  ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended September 30, 2016.

OR

(  ) TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _________ to __________.

Commission file number 1-11889

CEL-SCI CORPORATION
(Exact name of registrant as specified in its charter)
COLORADO	84-0916344
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
8229 Boone Blvd., Suite 802
Vienna, Virginia	22182
(Address of principal executive offices)	(Zip Code)

Registrant's telephone number, including area code: (703) 506-9460

Securities registered pursuant to Section 12(b) of the Act: None

Securities registered pursuant to Section 12(g) of the Act:

Common Stock, $.01 par value

Series S Warrants

(Title of Class)

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.  [  ]

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. [  ]

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes [X]      No [   ]

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).                          Yes  [X] No  [ ]

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein,  and will not be contained,  to the best of Registrant's  knowledge,  in definitive proxy or information  statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. [X]

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer  [ ]                                                                                                      Accelerated filer  [ X]

Non-accelerated filer  [ ]   (Do not check if a smaller reporting company)                           Smaller reporting company  [ ]

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act):  [  ] Yes   [X] No

The aggregate market value of the voting stock held by non-affiliates of the Registrant, based upon the closing sale price of the registrant’s common stock on March 31, 2016, as quoted on the NYSE MKT, was $60,807,407.

As of December 9, 2016, the Registrant had 188,724,407 issued and outstanding shares of common stock.

Documents Incorporated by Reference:   None

Explanatory Note

The purpose of the Amendment No. 1 on Form 10–K/A to CEL-SCI CORPORATION’s annual report of Form 10–K for the year ended September 30, 2016, filed with the Securities and Exchange Commission on December 14, 2016 (the “Form 10–K”), is solely to furnish Exhibit 101 to the Form 10–K in accordance with Rule 405 of Regulation S–T.

No other changes have been made to the Form 10–K. This Amendment No. 1 speaks as of the original filing date of the Form 10–K, does not reflect events that may have occurred subsequent to the original filing date and does not modify or update in any way disclosures made in the original Form 10–K.

ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

See the Financial Statements attached to this Report.

Exhibits
3(a)	Articles of Incorporation	Incorporated by reference to Exhibit 3(a) of CEL-SCI's combined Registration Statement on Form S-1 and Post-Effective Amendment ("Registration Statement"), Registration Nos. 2-85547-D and 33-7531.
3(b)	Amended Articles	Incorporated by reference to Exhibit 3(a) of CEL-SCI's Registration Statement on Form S-1, Registration Nos. 2-85547-D and 33-7531.
3(c)	Amended Articles (Name change only)	Filed as Exhibit 3(c) to CEL-SCI's Registration Statement on Form S-1 Registration Statement (No. 33-34878).
3(d)	Bylaws	Incorporated by reference to Exhibit 3(b) of CEL-SCI's Registration Statement on Form S-1, Registration Nos. 2-85547-D and 33-7531.
3(e)	Amended Bylaws	Incorporated by reference to Exhibit 3(ii) of CEL-SCI’s report on Form 8-K dated March 16, 2015.
4	Shareholders Rights Agreement, as Amended	Incorporated by reference to Exhibit 4 filed with CEL-SCI’s 10-K report for the year ended September 30, 2015.
4(b)	Incentive Stock Option Plan	Incorporated by reference to Exhibit 4 (b) filed on September 25, 2012 with the Company’s registration statement on Form S¬8 (File number 333-184092.
4(c)	Non-Qualified Stock Option Plan	Incorporated by reference to Exhibit 4 (b) filed on August 19, 2014 with the Company’s registration statement on Form S¬8 (File number 333-198244).
4(d)	Stock Bonus Plan	Incorporated by reference to Exhibit 4 (d) filed on September 25, 2012 with the Company’s registration statement on Form S¬8 (File number 333-184092.
4(e)	Stock Compensation Plan	Incorporated by reference to Exhibit 4 (e) filed on September 25, 2012 with the Company’s registration statement on Form S¬8 (File number 333-184092.
4(f)	2014 Incentive Stock Bonus Plan	Filed with this Amendment No. 2 to the Company’s annual report on Form 10-K for the year ended September 30, 2014.

10(f)	Securities Purchase Agreement (together with schedule required by Instruction 2 to Item 601 of Regulation S-K) pertaining to Series K notes and warrants, together with the exhibits to the Securities Purchase Agreement	Incorporated by reference to Exhibit 10 to CEL-SCI’s report on Form 8-K dated August 4, 2006.
10(g)	Subscription Agreement (together with Schedule required by Instruction 2 toItem 601 of Regulation S-K) pertaining to April 2007 sale of 20,000,000 shares of CEL-SCI’s common stock, 10,000,000 Series L warrants and 10,000,000 Series M Warrants	Incorporated by reference to Exhibit 10 of CEL-SCI’s report on Form 8-K dated April 18, 2007
10(h)	Warrant Adjustment Agreement with Laksya Ventures	Incorporated by reference to Exhibit 10(i) of CEL-SCI’s report on Form 8-K dated August 3, 2010
10(l)	First Amendment to Development Supply and Distribution Agreement with Orient Europharma.	Incorporated by reference to Exhibit 10(m) filed with CEL-SCI’s 10-K report for the year ended September 30, 2010.
10(m)	Exclusive License and Distribution Agreement with Teva Pharmaceutical Industries Ltd.	Incorporated by reference to Exhibit 10(n) filed with CEL-SCI’s 10-K report for the year ended September 30, 2010.
10(n)	Lease Agreement	Incorporated by reference to Exhibit 10(o) filed with CEL-SCI’s 10-K report for the year ended September 30, 2010.
10(o)	Promissory Note with Maximilian de Clara, together with Amendments 1 and 2	Incorporated by reference to Exhibit 10(p) filed with CEL-SCI’s 10-K report for the year ended September 30, 2010.
10(p)	Licensing Agreement with Byron Biopharma	Incorporated by reference to Exhibit 10(i) of CEL-SCI’s report on Form 8-K dated March 27, 2009
10(z)	Development, Supply and Distribution Agreement with Orient Europharma	Incorporated by reference to Exhibit 10(z) filed with CEL-SCI’s report on Form 10-K for the year ended September 30, 2003.
10(aa)	Securities Purchase Agreement and form of the Series F warrants, which is and exhibit to the Securities Purchase Agreement	Incorporated by reference to Exhibit 10(aa) of CEL-SCI’s report on Form 8-K dated October 3, 2011.
10(bb)	Placement Agent Agreement	Incorporated by reference to Exhibit 10(bb) of CEL-SCI’s report on Form 8-K dated October 3, 2011.
10(cc)	Securities  Purchase Agreement,  together with  the form of the Series H warrant, which is an exhibit to the securities Purchase Agreement	Incorporated by reference to Exhibit 10(cc) of CEL-SCI’s report on Form 8-K dated January 25, 2012.
10(dd)	Placement Agent Agreement	Incorporated by reference to Exhibit 10(dd) of CEL-SCI’s report on Form 8-K dated January 25, 2012.

10(ee)	Warrant Amendment Agreement, together with the form of the Series P warrant, which is an exhibit to the Warrant Amendment Agreement	Incorporated by reference to Exhibit 10(ee) of CEL-SCI’s report on Form 8-K dated February 10, 2012.
10(ff)	Placement Agent Agreement	Incorporated by reference to Exhibit 10(ff) of CEL-SCI’s report on Form 8-K dated February 10, 2012.
10(gg)	Securities  Purchase  Agreement  and the form of the  Series Q   warrant,  which is an  exhibit to the Securities Purchase Agreement	Incorporated by reference to Exhibit 10(gg) of CEL-SCI’s report on Form 8-K dated June 18, 2012.
10(hh)	Placement Agent Agreement	Incorporated by reference to Exhibit 10(hh) of CEL-SCI’s report on Form 8-K dated June 18, 2012.
10 (ii)	Securities  Purchase  Agreement  and the form of the  Series R   warrant,  which is an  exhibit to the Securities Purchase Agreement	Incorporated by reference to Exhibit 10(ii) of CEL-SCI’s report on Form 8-K dated December 5, 2012.
10 (jj)	Placement Agent Agreement	Incorporated by reference to Exhibit 10(jj)  of CEL-SCI’s report on Form 8-K dated December 5, 2012.
10 (nn)	Underwriting Agreement, together with the form of Series S warrant which is an exhibit to the underwriting agreement	Incorporated by reference to Exhibit 1.1 of CEL-SCI’s report on Form 8-K dated October 8, 2013.
10 (oo)	Underwriting Agreement, together with the form of Series S warrant which is an exhibit to the underwriting agreement	Incorporated by reference to Exhibit 1.1 of CEL-SCI’s report on Form 8-K dated December 19, 2013.
10 (pp)	Underwriting Agreement, together with the form of Series T warrant which is an exhibit to the warrant agent agreement	Incorporated by reference to Exhibit 1.1 of CEL-SCI’s report on Form 8-K dated April 15, 2014.
10 (qq)	Underwriting Agreement, together with the form of Series S warrant which is an exhibit to the warrant agent agreement	Incorporated by reference to Exhibit 1.1 of CEL-SCI’s report on Form 8-K dated October 23, 2014.
10 (rr)	Assignment and Assumption Agreement with Teva Pharmaceutical Industries, Ltd. and GCP Clinical Studies, Ltd.	Incorporated by reference to Exhibit 10(rr) of CEL-SCI’s report on Form 10-K/A report for the year ended September 30, 2014 dated April 17, 2015.
10 (ss)	Service Agreement with GCP Clinical Studies, Ltd., together with Amendment 1 thereto*	Incorporated by reference to Exhibit 10(ss) of CEL-SCI’s first amendment to its Form 10-K report for the year ended September 30, 2014 dated April 17, 2015.
10 (tt)	Joinder Agreement with PLIVA Hrvatska d.o.o.	Incorporated by reference to Exhibit 10(tt) of CEL-SCI’s first amendment to its Form 10-K report for the year ended September 30, 2014 dated April 17, 2015.
10 (uu)	Master Service Agreement with Ergomed Clinical Research, Ltd.,  and Clinical Trial Orders thereunder	Incorporated by reference to Exhibit 10(uu) of CEL-SCI’s first amendment to its Form 10-K report for the year ended September 30, 2014 dated April 17, 2015.

10 (vv)	Co-Development and Revenue Sharing Agreement with Ergomed Clinical Research Ltd., dated April 19, 2013, as amended	Incorporated by reference to Exhibit 10(vv) of CEL-SCI’s first amendment to its Form 10-K report for the year ended September 30, 2014 dated April 17, 2015.
10 (ww)	Co-Development and Revenue Sharing Agreement II:  Cervical Intraepithelial Neoplasia in HIV/HPV co-infected women, with Ergomed Clinical Research Ltd., dated October 10, 2013, as amended	Incorporated by reference to Exhibit 10(ww) of CEL- first amendment to its Form 10-K report for the year ended September 30, 2014 dated April 17, 2015.
10 (xx)	Co-Development and Revenue Sharing Agreement III: Anal warts and anal intraepithelial neoplasia in HIV/HPV co-infected patients, with Ergomed Clinical Research Ltd., dated October 24, 2013	Incorporated by reference to Exhibit 10(xx) of CEL-SCI’s first amendment to its Form 10-K report for the year ended September 30, 2014 dated April 17, 2015.
10 (yy)	Master Services Agreement with Aptiv Solutions, Inc.	Incorporated by reference to Exhibit 10(yy) of CEL-SCI’s first amendment to its Form 10-K report for the year ended September 30, 2014 dated April 17, 2015.
10 (zz)	Project Agreement Number 1 with Aptiv Solutions, Inc. together with Amendments 1 and 2 thereto*	Incorporated by reference to Exhibit 10(zz) of CEL-SCI’s first amendment to its Form 10-K report for the year ended September 30, 2014 dated April 17, 2015.
10 (aaa)	Second Amendment to Development Supply and Distribution Agreement with Orient Europharma	Incorporated by reference to Exhibit 10(aaa) of CEL-SCI’s first amendment to its Form 10-K report for the year ended September 30, 2014 dated April 17, 2015.
10 (bbb)	Amended and Restated Promissory Note with Maximilian de Clara	Incorporated by reference to Exhibit 10(bbb) of CEL-SCI’s report on Form 10-K/A report for the year ended September 30, 2014 dated April 17, 2015.
10 (ccc)	Placement Agent Agreement dated May 22, 2015 by and among CEL-SCI Corporation and Dawson James Securities, Inc.	Incorporated by reference to Exhibit 1.1 of CEL-SCI’s report on Form 8-K filed on May 26, 2015.
10 (ddd)	Warrant Agent Agreement (as amended), Series V warrants	Incorporated by reference to Exhibit 10 (ccc) of CEL-SCI’s report on Form 8-K filed on May 29, 2015.
10 (eee)	Assignment of Proceeds and Investment Agreement between CEL-SCI Corporation and Lake Whillans Vehicle 1.	Incorporated by reference to Exhibit 10 (ddd) of CEL-SCI’s report on Form 8-K filed on October 16, 2015.
10 (fff)	Placement Agent Agreement dated October 22, 2015 by and among CEL-SCI Corporation and Dawson James Securities, Inc.	Incorporated by reference to Exhibit 1.1 of CEL-SCI’s report on Form 8-K filed on October 23, 2015.
10 (ggg)	Warrant Agent Agreement, Series W warrants	Incorporated by reference to Exhibit 10 (eee) of CEL-SCI’s report on Form 8-K filed on October 23, 2015.

10 (iii)	Amendment to Co-Development and Revenue Sharing Agreement with Ergomed Clinical Research, Ltd., dated September 15, 2015	Incorporated by reference to Exhibit 10 (iii) filed with CEL-SCI’s 10-K report for the year ended September 30, 2015.
10 (jjj)	Securities Purchase Agreement	Incorporated by reference to Exhibit 10(jjj) of CEL-SCI’s report on Form 8-K dated May 19, 2016.
10 (kkk)	Securities Purchase Agreement	Incorporated by reference to Exhibit 10(kkk) of CEL-SCI’s report on Form 8-K dated August 24, 2016.
10 (lll)	Termination Agreement with Maximilian de Clara	Incorporated by reference to Exhibit 10(lll) of CEL-SCI’s report on Form 8-K dated September 2, 2016.
10 (mmm)	Employment Agreement with Geert Kersten (2016-2019)	Incorporated by reference to Exhibit 10(mmm) of CEL-SCI’s report on Form 8-K dated September 2, 2016.
10 (nnn)	Employment Agreement with Patricia Prichep (2016-2019)	Incorporated by reference to Exhibit 10(nnn) of CEL-SCI’s report on Form 8-K dated September 2, 2016.
10 (000)	Employment Agreement with Eyal Taylor (2016-2019)	Incorporated by reference to Exhibit 10(ooo) of CEL-SCI’s report on Form 8-K dated September 2, 2016.
23.1	Consent of BDO USA, LLP
31	Rule 13a-14(a) Certifications
32	Section 1350 Certifications

101.INS	XBRL Instance Document.**
101.SCH	XBRL Taxonomy Extension Schema Document.**
101.CAL	XBRL Taxonomy Calculation Linkbase Document.**
101.LAB	XBRL Taxonomy Label Linkbase Document.**
101.PRE	XBRL Taxonomy Presentation Linkbase Document.**
101.DEF	XBRL Taxonomy

* 

Portions of this exhibit have been omitted pursuant to a request for confidential treatment filed with the Commission under Rule 24b-2 of the Securities Exchange Act of 1934. The omitted confidential material has been filed separately with the Commission. The location of the omitted confidential information is indicated in the exhibit with asterisks (*)

SIGNATURES

In accordance with Section 13 or 15(a) of the Securities Exchange Act of 1934, the Registrant has caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized on the 15th day of December 2016.

CEL-SCI CORPORATION
By:	/s/ Geert R. Kersten
	Geert R. Kersten, Chief Executive Officer

Pursuant to the requirements of the Securities Act of l934, this Report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.

Signature	Title	Date
/s/ Geert R. Kersten	Chief Executive, Principal
Geert R. Kersten	Accounting, Principal Financial
	Officer and a Director	December 15, 2016
/s/ Alexander G. Esterhazy	Director	December 15, 2016
Alexander G. Esterhazy
/s/Peter R. Young	Director	December 15, 2016
Dr. Peter R. Young
/s/ Bruno Baillavoine	Director	December 15, 2016

EX-31.1

Exhibit 31

CERTIFICATIONS

I, Geert Kersten, of CEL-SCI Corporation, certify that:

1.           I have reviewed this amended annual report on Form 10-K/A of CEL-SCI Corporation;

2.           Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.           Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.           The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15 and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a)           designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b)           designed such internal control over financial reporting, or cause such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c)           evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;  and

d)           disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.           The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of the internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

a)           all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b)           any fraud, whether or not material, that involves management or other employees who have significant role in the registrant’s internal control over financial reporting.

December 15, 2016	By:	/s/ Geert R. Kersten
		Geert R. Kersten
		Principal Executive Officer

CERTIFICATIONS

I, Geert Kersten, of CEL-SCI Corporation, certify that:

1.           I have reviewed this amended annual report on Form 10-K/A of CEL-SCI Corporation;

2.           Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.           Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.           The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15 and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a)           designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b)           designed such internal control over financial reporting, or cause such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c)           evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;  and

d)           disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.           The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of the internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

a)           all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b)           any fraud, whether or not material, that involves management or other employees who have significant role in the registrant’s internal control over financial reporting.

December 15, 2016	By:	/s/ Geert R. Kersten
		Geert R. Kersten
		Principal Financial Officer

EX-32.1

Exhibit 32

In connection with the Amended Annual Report of CEL-SCI Corporation (the “Company”) on Form 10-K/A for the period ending September 30, 2016 as filed with the Securities and Exchange Commission (the “Report”), Geert Kersten, the Chief Executive and Principal Financial Officer of the Company, certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of his knowledge:

(1)  

The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2)  

The information contained in the Report fairly presents, in all material respects the financial condition and results of the Company.

December 15, 2016	By:	/s/ Geert R. Kersten
		Geert Kersten, Chief Executive and Principal Financial and Accounting Officer

XML

Document and Entity Information - USD ($)	12 Months Ended
	Sep. 30, 2016	Dec. 09, 2016	Mar. 31, 2016
Document And Entity Information
Entity Registrant Name	CEL SCI CORP
Entity Central Index Key	0000725363
Document Type	10-K
Document Period End Date	Sep. 30, 2016
Amendment Flag	false
Current Fiscal Year End Date	--09-30
Is Entity a Well-known Seasoned Issuer?	No
Is Entity a Voluntary Filer?	No
Is Entity's Reporting Status Current?	Yes
Entity Filer Category	Accelerated Filer
Entity Common Stock, Shares Outstanding		188,724,407
Entity Public Float			$ 60,807,407
Document Fiscal Period Focus	FY
Document Fiscal Year Focus	2016

XML

BALANCE SHEETS - USD ($)	Sep. 30, 2016	Sep. 30, 2015
CURRENT ASSETS:
Cash and cash equivalents	$ 2,917,996	$ 5,726,682
Receivables	394,515	87,214
Prepaid expenses	981,677	979,655
Deposits - current portion	154,995	150,000
Inventory used for R&D and manufacturing	1,008,642	1,401,839
Deferred rent - current portion	429,821	487,793
Total current assets	5,887,646	8,833,183
RESEARCH AND OFFICE EQUIPMENT, net	226,216	307,466
PATENT COSTS, net	256,547	291,564
DEFERRED RENT - net of current portion	3,406,921	4,044,473
DEPOSITS - net of current portion	1,820,917	1,970,917
TOTAL ASSETS	11,598,247	15,447,603
CURRENT LIABILITIES:
Accounts payable	3,091,512	5,128,682
Accrued expenses	378,672	88,575
Due to employees	538,278	365,131
Related party loan	0	1,104,057
Deferred rent - current portion	3,310	9,997
Lease obligation - current portion	0	9,028
Total current liabilities	4,011,772	6,705,470
Derivative instruments - net of current portion	8,394,934	13,686,587
Deferred revenue	125,000	126,639
Deferred rent - net of current portion	17,609	9,026
Deposits held	5,000	5,000
Total liabilities	12,554,315	20,532,722
STOCKHOLDERS' DEFICIT
Preferred stock, $.01 par value-200,000 shares authorized; -0- shares issued and outstanding	0	0
Common stock, $.01 par value - 600,000,000 shares authorized; 155,962,079 and 112,360,568 shares issued and outstanding	1,559,621	1,123,606
Additional paid-in capital	283,152,288	267,992,754
Accumulated deficit	(285,667,977)	(274,201,479)
Total stockholders' deficit	(956,068)	(5,085,119)
TOTAL LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY	$ 11,598,247	$ 15,447,603

XML

BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2016	Sep. 30, 2015
Stockholders Equity
Preferred Stock Shares Par Value	$ 0.01	$ 0.01
Preferred Stock Shares Authorized	200,000	200,000
Preferred Stock Shares Issued	0	0
Preferred Stock Shares Outstanding	0	0
Common Stock Shares Par Value	$ 0.01	$ 0.01
Common Stock Shares Authorized	600,000,000	600,000,000
Common Stock Shares Issued	155,962,079	112,360,568
Common Stock Shares Outstanding	155,962,079	112,360,568

XML

STATEMENTS OF OPERATIONS - USD ($)	12 Months Ended
	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2014
Income Statement [Abstract]
GRANT INCOME AND OTHER	$ 285,055	$ 657,377	$ 264,033
OPERATING EXPENSES:
Research and development	19,351,779	21,098,147	17,172,587
General & administrative	6,486,501	13,855,775	10,665,558
Total operating expenses	25,838,280	34,953,922	27,838,145
OPERATING LOSS	(25,553,225)	(34,296,545)	(27,574,112)
GAIN ON DERIVATIVE INSTRUMENTS	14,013,726	282,616	248,767
LOSS ON DEBT EXTINGUISHMENT	0	(620,457)	0
INTEREST INCOME (EXPENSE), net	73,001	(40,260)	(40,920)
NET LOSS	(11,466,498)	(34,674,646)	(27,366,265)
ISSUANCE OF ADDITIONAL SHARES DUE TO RESET PROVISIONS	0	0	(1,117,447)
NET LOSS AVAILABLE TO COMMON SHAREHOLDERS	$ (11,466,498)	$ (34,674,646)	$ (28,483,712)
NET LOSS PER COMMON SHARE
BASIC	$ (0.09)	$ (0.42)	$ (0.48)
DILUTED	$ (0.09)	$ (0.42)	$ (0.49)
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING
BASIC and DILUTED	121,655,108	82,519,027	58,804,622

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STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($)	Common Stock	Additional Paid-In Capital	Accumulated Deficit	Total
BALANCE at Sep. 30, 2013	$ 310,250	$ 218,550,408	$ (212,160,568)	$ 6,700,090
BALANCE, Shares at Sep. 30, 2013	31,025,019
Sale of stock	$ 317,555	28,129,691	0	28,447,246
Sale of stock, Shares	31,755,494
Issuance of warrants in connection with sale of common stock		(7,791,448)	0	(7,791,448)
401(k) contributions paid in common stock	$ 1,647	153,787	0	155,434
401(k) contributions paid in common stock, Shares	164,787
Exercise of warrants	$ 26,686	4,253,632	0	4,280,318
Exercise of warrants, Shares	2,668,508
Conversion of warrant liability to equity		1,308,528		1,308,528
Stock issued to nonemployees for service	$ 5,800	621,318	0	627,118
Stock issued to nonemployees for service, Shares	579,968
Stock issued for patents	$ 87	9,912	0	9,999
Stock issued for patents, Shares	8,695
Modification of options issued to consultants		76,991	0	76,991
Issuance of restricted stock	$ 157,000	$ (157,000)	$ 0	$ 0
Issuance of restricted stock, Shares	15,700,000
Equity based compensation - employees, Shares		3,958,637	0	3,958,637
Equity based compensation - non-employees		$ 36,752	$ 0	$ 36,752
Net loss		0	(27,366,265)	(27,366,265)
BALANCE at Sep. 30, 2014	$ 819,025	249,151,208	(239,526,833)	10,443,400
BALANCE, Shares at Sep. 30, 2014	81,902,471
Sale of stock	$ 294,679	20,853,699	0	21,148,378
Sale of stock, Shares	29,467,901
Issuance of warrants in connection with sale of common stock	$ 0	(8,463,957)	0	(8,463,957)
401(k) contributions paid in common stock	$ 2,432	163,214	0	165,646
401(k) contributions paid in common stock, Shares	243,178
Stock issued to nonemployees for service	$ 7,400	526,576	0	533,976
Stock issued to nonemployees for service, Shares	739,968
Modification of options issued to consultants				0
Modification of warrants and extinguishment loss	$ 0	620,457	0	620,457
Forfeiture of unvested restricted stock	$ (1,000)	1,000	0	0
Forfeiture of unvested restricted stock, Shares	(100,000)
Equity based compensation - employees	$ 1,070	5,104,757	0	5,105,827
Equity based compensation - employees, Shares	107,050
Equity based compensation - non-employees	$ 0	35,800	0	35,800
Net loss		0	(34,674,646)	(34,674,646)
BALANCE at Sep. 30, 2015	$ 1,123,606	267,992,754	(274,201,479)	(5,085,119)
BALANCE, Shares at Sep. 30, 2015	112,360,568
Sale of stock	$ 415,232	20,958,464	0	21,373,696
Sale of stock, Shares	41,523,248
Issuance of warrants in connection with sale of common stock		(8,722,073)		(8,722,073)
401(k) contributions paid in common stock	$ 4,085	157,486	0	161,571
401(k) contributions paid in common stock, Shares	408,497
Stock issued to nonemployees for service	$ 12,489	677,824	0	690,313
Stock issued to nonemployees for service, Shares	1,248,831
Modification of options issued to consultants				0
Equity based compensation - employees	$ 4,209	2,008,474	0	2,012,683
Equity based compensation - employees, Shares	420,935
Equity based compensation - non-employees		79,359		79,359
Net loss			(11,466,498)	(11,466,498)
BALANCE at Sep. 30, 2016	$ 1,559,621	$ 283,152,288	$ (285,667,977)	$ (956,068)
BALANCE, Shares at Sep. 30, 2016	155,962,079

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STATEMENTS OF CASH FLOWS - USD ($)	12 Months Ended
	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2014
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (11,466,498)	$ (34,674,646)	$ (27,366,265)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	150,243	206,750	231,752
Issuance of common stock and options for services - non-employees	751,651	565,915	694,955
Modification of warrants issued to consultants	0	0	76,991
Equity based compensation	2,113,433	5,105,827	3,958,637
Common stock contributed to 401(k) plan	161,571	165,646	155,434
Impairment loss on abandonment of patents	0	0	1,182
Loss on retired equipment	248	313	268
Gain on derivative instruments	(14,013,726)	(282,616)	(248,767)
Loss on debt extinguishment	0	620,457	0
(Increase)/decrease in assets:
Receivables	(1,960)	(5,394)	(7,557)
Deferred rent	695,524	745,673	769,159
Prepaid expenses	15,999	(68,268)	(158,088)
Inventory used for R&D and manufacturing	393,197	50,181	(435,392)
Deposits	145,005	150,000	(200,000)
Increase/(decrease) in liabilities:
Accounts payable	(2,389,931)	3,981,886	(751,971)
Accrued expenses	290,097	(458,633)	433,712
Deferred revenue	(1,639)	48	46
Due to employees	72,397	57,170	(78,376)
Deferred rent liability	1,896	6,358	(3,739)
Net cash used in operating activities	(23,082,493)	(23,833,333)	(22,928,019)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of equipment	(31,405)	(73,399)	(103,977)
Expenditures for patent costs	(2,819)	(20,132)	(34,887)
Net cash used in investing activities	(34,224)	(93,531)	(138,864)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock and warrants	21,420,301	21,148,378	28,428,641
Payment on related party loan	(1,104,057)
Proceeds from exercise of warrants	0	0	3,118,387
Payments on obligations under capital lease	(8,213)	(8,452)	(8,137)
Net cash provided by financing activities	20,308,031	21,139,926	31,538,891
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS	(2,808,686)	(2,786,938)	8,472,008
CASH AND CASH EQUIVALENTS, BEGINNING OF YEAR	5,726,682	8,513,620	41,612
CASH AND CASH EQUIVALENTS, END OF YEAR	2,917,996	5,726,682	8,513,620
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Receivable due under the litigation funding arrangement offset by the same amount payable to the legal firm providing the services	305,341	0	0
Research and office equipment included in accounts payable at year end	0	(2,345)	(1,074)
Capitalizable patent costs included in accounts payable at year end	0	(11,685)	4,474
Patent costs purchased with common stock	0	0	9,999
Lease payments included in accounts payable at year end	815	43	3,477
Fair value of warrant liabilities on the date of issuance reclassed to liabilities	(8,722,073)	(8,463,957)	(5,320,989)
Financing costs included in accounts payable at year end	46,605	0	0
Forfeiture of unvested restricted stock	0	1,000	0
Stock issued under an anti-dilution provision and cashless exercise of warrants	0	0	(16,375)
Prepaid amount under consulting services paid with issuance of common stock	18,021	3,861	31,085
Cash paid for interest expense	$ 43,673	$ 147,166	$ 180,654

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1. ORGANIZATION

12 Months Ended

Sep. 30, 2016

Notes to Financial Statements

A. ORGANIZATION

CEL-SCI Corporation (the Company) was incorporated on March 22, 1983, in the state of Colorado, to finance research and development in biomedical science and ultimately to engage in marketing and selling products.

CEL-SCI is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. The Company’s lead investigational therapy, Multikine (Leukocyte Interleukin, Injection), is currently in a Phase 3 clinical trial as a potential therapeutic agent directed at using the immune system to produce an anti-tumor immune response for advanced primary head and neck cancer. Data from Phase 1 and Phase 2 clinical trials suggest Multikine has the potential to directly affect tumor cells. These data also indicate that it appears to activate the patient’s own anti-tumor immune response. Multikine (Leukocyte Interleukin, Injection) is the full name of this investigational therapy, which, for simplicity, is referred to in the remainder of this document as Multikine. Multikine is the trademark that the Company has registered for this investigational therapy, and 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 by the FDA or any other regulatory agency. Neither has its safety or efficacy been established for any use. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress and that is currently subject to a clinical hold on enrollment of additional new patients.

Multikine has been cleared by the regulators in twenty four countries around the world, including the U.S. FDA, for a global Phase 3 clinical trial in advanced primary (not yet treated) head and neck cancer patients. On September 26, 2016, the Company received verbal notice from the FDA that the Phase 3 clinical trial has been placed on clinical hold. The FDA’s partial clinical hold letter identified the following specific deficiencies: there is an unreasonable and significant risk of illness or injury to human subjects; the investigator brochure is misleading, erroneous, and materially incomplete; and that the plan or protocol is deficient in design to meet its stated objectives. Pursuant to this communication from FDA, patients currently receiving study treatments could continue to receive treatment, and patients already enrolled in the study would continue to be followed, but no additional patients could be enrolled. On October 21, 2016, the Company announced it had received the Partial Clinical Hold letter from the FDA. On November 21, 2016, the Company announced it has submitted what it believes to be a complete response to the FDA. On December 8, 2016, the FDA advised CEL-SCI that the agency was denying CEL-SCI’s request for a meeting at this time because FDA’s review of CEL-SCI’s November 17, 2016 response was ongoing. CEL-SCI was also advised that it will be receiving a letter addressing CEL-SCI’s response by December 18, 2016.

Multikine is also being used in a Phase 1 study at the University of California, San Francisco (UCSF) in HIV/HPV co-infected men and women with peri-anal warts.

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2. OPERATIONS, FINANCING

12 Months Ended

Sep. 30, 2016

Notes to Financial Statements

2. OPERATIONS, FINANCING

The Company has incurred significant costs since its inception in connection with the acquisition of certain patented and unpatented proprietary technology and know-how relating to the human immunological defense system, patent applications, research and development, administrative costs, construction of laboratory facilities, and clinical trials.  The Company has funded such costs with proceeds from loans and the public and private sale of its common and preferred stock. 

The Company is currently running a large multi-national Phase 3 clinical trial for head and neck cancer. The Company believes that it has enough capital to support its operations as it believes that it has ready access to new equity capital should the need arise. During fiscal year 2016, the Company raised approximately $21.4 million in net proceeds through the sale of common stock and warrants from public and private offerings. During fiscal year 2015, the Company raised $21.1 million net proceeds from public offerings. To finance the study beyond the next 12 months, the Company plans to raise additional capital in the form of corporate partnerships, debt and/or equity financings. In addition, the Company expects to receive proceeds from the arbitration against its former clinical research organization, inVentiv. The Company believes that it will be able to obtain additional financing because it has done so consistently in the past, and because Multikine is a product in the Phase 3 clinical trial stage. However, there can be no assurance that the Company will be successful in raising additional funds or that funds will be available to the Company on acceptable terms or at all.  If the Company does not raise the necessary capital, the Company will either have to slow or delay the Phase 3 clinical trial or even significantly curtail its operations until such time as it is able to raise the required funding. The financial statements have been prepared assuming that the Company will continue as a going concern, but due to the Company’s future liquidity needs, history of net losses, and the expectation that the Company will incur losses for the foreseeable future, there is substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Since the Company launched its Phase 3 clinical trial for Multikine, the Company has spent approximately $34.5 million as of September 30, 2016 on direct costs for the Phase 3 clinical trial. The total remaining cash cost of the Phase 3 clinical trial, excluding any costs that will be paid by CEL-SCI’s partners, would approximately be $12.1 million after September 30, 2016. This is based on the executed contract costs with the CROs only and does not include other related cost, e.g. the manufacturing of the drug. It should be noted that this estimate is based only on the information currently available in the Company’s contracts with the Clinical Research Organizations responsible for managing the Phase 3 clinical trial.  This number can be affected by the speed of enrollment, foreign currency exchange rates and many other factors, some of which cannot be foreseen.  The Company has filed an amendment to the original Phase 3 protocol for it head and neck cancer study with the FDA to allow for this expansion in patient enrollment. Should the FDA allow the amended protocol filed with them to proceed, the remaining cost of the Phase 3 clinical trial will be higher. It is therefore possible that the cost of the Phase 3 clinical trial will be higher than currently estimated.

On September 26, 2016, the Company received verbal notice from the FDA that the Phase 3 clinical trial has been placed on clinical hold. Pursuant to this communication from FDA, patients currently receiving study treatments could continue to receive treatment, and patients already enrolled in the study would continue to be followed, but no additional patients could be enrolled. On October 21, 2016, the Company announced it had received the Partial Clinical Hold letter from the FDA. On November 21, 2016, the Company announced it has submitted a complete response to the FDA and will work diligently with the FDA to seek to have the partial clinical hold lifted.

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3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

12 Months Ended

Sep. 30, 2016

Summary Of Significant Accounting Policies

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Cash and Cash Equivalents – For purposes of the statements of cash flows, cash and cash equivalents consist principally of unrestricted cash on deposit and short-term money market funds. The Company considers all highly liquid investments with a maturity when purchased of less than three months as cash and cash equivalents.

Prepaid Expenses – Prepaid expenses are payments for future services to be rendered and are expensed over the time period for which the service is rendered. Prepaid expenses may also include payment for goods to be received within one year of the payment date.

Inventory – Inventory consists of manufacturing production advances and bulk purchases of laboratory supplies to be consumed in the manufacturing of the Company’s product for clinical studies. Inventories are stated at the lower of cost or market, where cost is determined using the first-in, first out method applied on a consistent basis.

Deposits – The deposits are required by the lease agreement for the manufacturing facility and by the clinical research organization (CRO) agreements.

Research and Office Equipment– Research and office equipment is recorded at cost and depreciated using the straight-line method over estimated useful lives of five to seven years. Leasehold improvements are depreciated over the shorter of the estimated useful life of the asset or the term of the lease. Repairs and maintenance which do not extend the life of the asset are expensed when incurred. The fixed assets are reviewed on a quarterly basis to assess impairment, if any.

Patents – Patent expenditures are capitalized and amortized using the straight-line method over the shorter of the expected useful life or the legal life of the patent (17 years). In the event changes in technology or other circumstances impair the value or life of the patent, appropriate adjustment to the asset value and period of amortization is made. An impairment loss is recognized when estimated future undiscounted cash flows expected to result from the use of the asset, and from disposition, are less than the carrying value of the asset. The amount of the impairment loss would be the difference between the estimated fair value of the asset and its carrying value.

Deferred Rent (Asset) – Consideration paid, including deposits, related to operating leases is recorded as a deferred rent asset and amortized as rent expense over the lease term. Interest on the deferred rent is calculated at 3% on the funds deposited on the manufacturing facility and is included in deferred rent. This interest income will be used to offset future rent.

Deferred Rent (Liability) – Certain of the Company’s operating leases provide for minimum annual payments that adjust over the life of the lease.  The aggregate minimum annual payments are expensed on a straight-line basis over the minimum lease term. The Company recognizes a deferred rent liability for rent escalations when the amount of straight-line rent exceeds the lease payments, and reduces the deferred rent liability when the lease payments exceed the straight-line rent expense.  For tenant improvement allowances and rent holidays, the Company records a deferred rent liability and amortizes the deferred rent over the lease term as a reduction to rent expense.

Derivative Instruments - The Company has entered into financing arrangements that consist of freestanding derivative instruments that contain embedded derivative features, specifically, the settlement provisions in the warrant agreements preclude the warrants from being treated as equity. The Company accounts for these arrangements in accordance with Accounting Standards Codification (ASC) 815, “Accounting for Derivative Instruments and Hedging Activities”. In accordance with accounting principles generally accepted in the United States (U.S. GAAP), derivative instruments and hybrid instruments are recognized as either assets or liabilities on the balance sheet and are measured at fair value with gains or losses recognized in earnings or other comprehensive income depending on the nature of the derivative or hybrid instruments. The Company determines the fair value of derivative instruments and hybrid instruments based on available market data using appropriate valuation models, giving consideration to all of the rights and obligations of each instrument. The derivative liabilities are remeasured at fair value at the end of each reporting period as long as they are outstanding. 

Grant Income – The Company's grant arrangements are handled on a reimbursement basis. Grant income under the arrangements is recognized when costs are incurred.

Research and Development Costs – Research and development expenditures are expensed as incurred.

Net Loss Per Common Share – The Company calculates net loss per common share in accordance with ASC 260 “Earnings Per Share” (ASC 260). Basic and diluted net loss per common share was determined by dividing net loss applicable to common shareholders by the weighted average number of common shares outstanding during the period. The Company’s potentially dilutive shares, which include outstanding common stock options, restricted stock units, convertible preferred stock and common stock warrants, have not been included in the computation of diluted net loss per share for all periods as the result would be anti-dilutive.

Concentration of Credit Risk – Financial instruments, which potentially subject the Company to concentrations of credit risk, consist of cash and cash equivalents.  The Company maintains its cash and cash equivalents with high quality financial institutions.  At times, these accounts may exceed federally insured limits.  The Company has not experienced any losses in such bank accounts.  The Company believes it is not exposed to significant credit risk related to cash and cash equivalents. All non-interest bearing cash balances were fully insured up to $250,000 at September 30, 2016.

Income Taxes – The Company uses the asset and liability method of accounting for income taxes. Under the asset and liability method, deferred tax assets and liabilities are recognized for future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating and tax loss carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The Company records a valuation allowance to reduce the deferred tax assets to the amount that is more likely than not to be recognized. A full valuation allowance was recorded against the deferred tax assets as of September 30, 2016 and 2015. 

Use of Estimates – The preparation of financial statements in conformity U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the accompanying disclosures. These estimates are based on management’s best knowledge of current events and actions the Company may undertake in the future. Estimates are used in accounting for, among other items, inventory obsolescence, accruals, stock options, useful lives for depreciation and amortization of long-lived assets, deferred tax assets and the related valuation allowance, and the valuation of derivative liabilities.Actual results could differ from estimates, although management does not generally believe such differences would materially affect the financial statements in any given year. However, in regard to the valuation of derivative liabilities determined using various valuation techniques including the Black-Scholes and binomial pricing methodologies, significant fluctuations may materially affect the financial statements in a given year. The Company considers such valuations to be significant estimates.

Fair Value Measurements – The Company evaluates financial assets and liabilities subject to fair value measurements in accordance with a fair value hierarchy to prioritize the inputs used to measure fair value. A financial instrument’s level within the fair value hierarchy is based on the lowest level of input significant to the fair value measurement, where Level 1 is the highest and Level 3 is the lowest. See Note 12 for the definition of levels and the classification of assets and liabilities in those levels.

Stock-Based Compensation – Compensation cost for all stock-based awards is measured at fair value as of the grant date in accordance with the provisions of ASC 718, “Compensation – Stock Compensation.” The fair value of stock options is calculated using the Black-Scholes option pricing model. The Black-Scholes model requires various judgmental assumptions including volatility and expected option life. The stock-based compensation cost is recognized on the straight line allocation method as expense over the requisite service or vesting period.

Equity instruments issued to non-employees are accounted for in accordance with ASC 505-50, “Equity-Based Payments to Non-Employees.” Accordingly, compensation is recognized when goods or services are received and may be measured using the Black-Scholes valuation model, based on the type of award. The Black-Scholes model requires various judgmental assumptions regarding the fair value of the equity instruments at the measurement date and the expected life of the options.

The Company has Incentive Stock Option Plans, Non-Qualified Stock Options Plans, a Stock Compensation Plan, Stock Bonus Plans and an Incentive Stock Bonus Plan. In some cases, these Plans are collectively referred to as the “Plans.” All Plans have been approved by the Company’s stockholders.

The Company’s stock options are not transferable, and the actual value of the stock options that an employee may realize, if any, will depend on the excess of the market price on the date of exercise over the exercise price. The Company has based its assumption for stock price volatility on the variance of daily closing prices of the Company’s stock. The risk-free interest rate assumption was based on the U.S. Treasury rate at date of the grant with term equal to the expected life of the option. Historical data was used to estimate option exercise and employee termination within the valuation model. The expected term of options represents the period of time that options granted are expected to be outstanding and has been determined based on an analysis of historical exercise behavior. If any of the assumptions used in the Black-Scholes model change significantly, stock-based compensation expense for new awards may differ materially in the future from that recorded in the current period. 

Vesting of restricted stock granted under the Incentive Stock Bonus Plan is subject to service, performance or market conditions and meets the classification of equity awards. These awards were measured at fair market value on the grant-dates for issuances where the attainment of performance criteria is probable and at fair value on the grant-dates, using a Monte Carlo simulation for issuances where the attainment of performance criteria is uncertain. The total compensation cost will be expensed over the estimated requisite service period.

Reclassification – Certain prior year items have been reclassified to conform to the current year presentation.

Recent Accounting Pronouncements – In May 2014, the FASB issued Accounting Standards Update (ASU) 2014-09, Revenue from Contracts with Customers (Topic 606) that will supersede virtually all recognition guidance in US GAAP. For public entities, the guidance is effective for annual and interim periods beginning after December 15, 2017. Early adoption is permitted for all entities for annual and interim periods beginning after December 15, 2016. The FASB issued the following ASUs to amend the new guidance: ASU 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date, ASU 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net), ASU 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing, and ASU 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients. Management does not expect the new standard or any of the related updates to have a material effect on its financial statements and related disclosures.

In January 2016, the FASB issued Accounting Standards Update (ASU) No. 2016-01, Financial Instruments – Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities. The new guidance is intended to improve the recognition and measurement of financial instruments. The new guidance is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. Early adoption is permitted for specific provisions within the guidance. Management does not expect the new standard to have a material effect on its financial statements and related disclosures.

In February 2016, the FASB issued ASU 2016-02, Leases, which will require most leases (with the exception of leases with terms of less than one year) to be recognized on the balance sheet as an asset and a lease liability. Leases will be classified as an operating lease or a financing lease. Operating leases are expensed using the straight-line method whereas financing leases will be treated similarly to a capital lease under the current standard. The new standard will be effective for annual and interim periods, within those fiscal years, beginning after December 15, 2018, but early adoption is permitted. The new standard must be presented using the modified retrospective method beginning with the earliest comparative period presented. The Company is currently evaluating the effect of the new standard on its financial statements and related disclosures.

In March 2016, the FASB issued ASU No. 2016-09, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. ASU 2016-09 simplifies several aspects of the accounting for share-based payment award transactions, including income tax consequences, classification of awards as either equity or liabilities and classification on the statement of cash flows. The new standard will be effective for annual and interim periods, within those fiscal years, beginning after December 15, 2016 but early adoption is permitted. The Company is currently evaluating the effect of the new amendment on its financial statements and related disclosures.

In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments. ASU 2016-15 amends eight specific cash flow issues: 1.) Debt Prepayment or Debt Extinguishment Costs, 2.) Settlement of Zero-Coupon Debt Instruments or Other Debt Instruments with Coupon Interest Rates That Are Insignificant in Relation to the Effective Interest Rate of the Borrowing, 3.) Contingent Consideration Payments Made after a Business Combination, 4.) Proceeds from the Settlement of Insurance Claims, 5.) Proceeds from the Settlement of Corporate-Owned Life Insurance Policies, including Bank-Owned Life Insurance Policies, 6.) Distributions Received from Equity Method Investees, 7.) Beneficial Interests in Securitization Transactions, 8.) Separately Identifiable Cash Flows and Application of the Predominance Principle. Management does not expect the adoption of the amendments in this Update to have a material effect on its financial statements and related disclosures.

In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash. ASU 2016-18 requires that a statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Therefore, amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The amendments in this Update are effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. Management does not expect the adoption of the amendments in this Update to have a material effect on its financial statements and related disclosures.

The Company has considered all other recently issued accounting pronouncements and does not believe the adoption of such pronouncements will have a material impact on its financial statements.

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4. DERIVATIVES LIABILITIES, WARRANTS AND OTHER OPTIONS

12 Months Ended

Sep. 30, 2016

Derivative Instruments and Hedging Activities Disclosure [Abstract]

4. DERIVATIVES LIABILITIES, WARRANTS AND OTHER OPTIONS

The following chart represents the warrants and non-employee options outstanding at September 30, 2016:

Warrant	Issue Date	Shares Issuable upon Exercise of Warrant	Exercise Price	Expiration Date	Refer-ence
Series R	12/6/12	2,625,000	$4.00	12/6/16	1
Series S	10/11/13 -10/24/14	25,928,010	$1.25	10/11/18	1
Series U	4/17/14	445,514	$1.75	10/17/17	1
Series V	5/28/15	20,253,164	$0.79	5/28/20	1
Series W	10/28/15	17,223,248	$0.67	10/28/20	1
Series X	1/13/16	3,000,000	$0.37	1/13/21	2
Series Y	2/15/16	650,000	$0.48	2/15/21	2
Series Z	5/23/16	6,600,000	$0.55	11/23/21	1
Series ZZ	5/23/16	500,000	$0.55	5/18/21	1
Series AA	8/26/16	5,000,000	$0.55	2/22/22	1
Series BB	8/26/16	400,000	$0.55	8/22/21	1
Series N	8/18/08	2,844,627	$0.53	8/18/17	2
Series P	2/10/12	590,001	$4.50	3/6/17	2
Consultants	12/2/11- 7/1/16	640,000	$0.37-  $3.50	10/27/16- 6/30/19	3

The following chart represents the warrants and non-employee options outstanding at September 30, 2015:

Warrants	Issue Date	Shares Issuable upon Exercise of Warrants	Exercise Price	Expiration Date	Refer-ence
Series N	8/18/08	2,844,627	0.53	8/18/17	1
Series Q	6/21/12	1,200,000	5.00	12/22/15	1
Series R	12/6/12	2,625,000	4.00	12/6/16	1
Series S	10/11/13- 10/24/14	25,928,010	1.25	10/11/18	1
Series U	4/17/14	445,514	1.75	10/17/17	1
Series V	5/28/15	20,253,164	0.79	5/28/20	1
Series P	2/10/12	590,001	4.50	3/6/17	2
Consultants	10/14/05 – 7/1/15	238,000	0.66 – 20.00	10/14/15 - 6/30/18	3

1. Warrant Liabilities

The table below presents the warrants accounted for as derivative liabilities at September 30.

	2016	2015
Series S warrants	$ 3,111,361	$ 7,363,555
Series U warrants	-	44,551
Series V warrants	1,620,253	6,278,481
Series W warrants	1,799,858	-
Series Z warrants	970,604	-
Series ZZ warrants	70,609	-
Series AA warrants	763,661	-
Series BB warrants	58,588	-
Total derivative liabilities	$ 8,394,934	$ 13,686,587

The table below presents the gains and (losses) on the warrant liabilities for the years ended September 30:

Warrant Series	2016	2015	2014
Series A - E	$ -	$ 6,105	$ 1
Series F and G	-	-	12,667
Series H	-	12,000	24,000
Series N	-	-	(1,404,027)
Series Q	-	12,000	36,000
Series R	-	157,500	131,250
Series S	4,252,193	(1,705,466)	1,098,787
Series T	-	-	276,122
Series U	44,552	75,738	73,967
Series V	4,658,228	1,724,739	-
Series W	3,260,913	-	-
Series Z	997,226	-	-
Series ZZ	75,229	-	-
Series AA	672,246	-	-
Series BB	53,139	-	-
Net gain	$ 14,013,726	$ 282,616	$ 248,767

The Company reviews all outstanding warrants in accordance with the requirements of ASC 815. This topic provides that an entity should use a two-step approach to evaluate whether an equity-linked financial instrument (or embedded feature) is indexed to its own stock, including evaluating the instrument’s contingent exercise and settlement provisions. The warrant agreements provide for adjustments to the exercise price for certain dilutive events. Under the provisions of ASC 815, the warrants are not considered indexed to the Company’s stock because future equity offerings or sales of the Company’s stock are not an input to the fair value of a “fixed-for-fixed” option on equity shares, and equity classification is therefore precluded.

In accordance with ASC 815, derivative liabilities must be measured at fair value upon issuance and re-valued at the end of each reporting period through expiration. Any change in fair value between the respective reporting periods is recognized as a gain or loss in the statement of operations.

Expired warrants

As of September 30, 2015, all Series A, B, C, E, F, G, H, and Q warrants had expired.

Series R Warrants

On December 4, 2012, the Company sold 3,500,000 shares of its common stock for $10,500,000, or $3.00 per share, in a registered direct offering. The investors in this offering also received Series R warrants which entitle the investors to purchase up to 2,625,000 shares of the Company’s common stock. The Series R warrants may be exercised at any time before December 6, 2016 at a price of $4.00 per share. The fair value at issuance of the warrants of $4.2 million was recorded as a warrant liability.

Series S Warrants

On October 11, 2013, the Company closed a public offering of 17,826,087 units of common stock and warrants at a price of $1.00 per unit for net proceeds of approximately $16.4 million, net of underwriting discounts and commissions and offering expenses of the Company. Each unit consisted of one share of common stock and one Series S warrant to purchase one share of common stock. The Series S warrants were immediately exercisable, expire on October 11, 2018, and have an exercise price of $1.25. In November 2013, the underwriters purchased an additional 2,648,913 warrants pursuant to the overallotment option, for which the Company received net proceeds of $24,370. The fair value at issuance of the Series S warrants of $6.1 million was recorded as a warrant liability.

On December 24, 2013, the Company closed a public offering of 4,761,905 units of common stock and warrants at a price of $0.63 per unit for net proceeds of approximately $2.8 million, net of underwriting discounts and commissions and offering expenses of the Company. Each unit consisted of one share of common stock and one Series S warrant to purchase one share of common stock. The underwriters purchased an additional 476,190 units of common stock and warrants pursuant to the overallotment option, for which the Company received net proceeds of approximately $279,000. The fair value at issuance of the Series S warrants of approximately $1.2 million was recorded as a warrant liability. On February 7, 2014, the Series S warrants began trading on the NYSE MKT under the symbol CVM WT.

On October 24, 2014, the Company closed an underwritten public offering of 7,894,737 shares of common stock and 1,973,684 Series S warrants to purchase shares of common stock. Additionally, on October 21, 2014, the Company sold 1,320,000 shares of common stock and 330,000 Series S warrants to purchase shares of common stock in a private offering. The common stock and Series S warrants were sold at a combined per unit price of $0.76 for net proceeds of approximately $6.4 million, net of underwriting discounts and commissions and offering expenses. The fair value at issuance of the Series S warrants of approximately $461,000 was added to the existing Series S warrant liability.

During the years ended September 30, 2016 and 2015, no Series S warrants were exercised. During the year ended September 30, 2014, 2,088,769 Series S Warrants were exercised, and the Company received proceeds of approximately $2.6 million.

Series T and U Warrants

On April 17, 2014, the Company closed a public offering of 7,128,229 shares of common stock at a price of $1.40 and 1,782,057 Series T warrants to purchase one share of common stock for net proceeds of approximately $9.2 million, net of underwriting commissions and offering expenses. The Series T warrants were immediately exercisable and had an exercise price of $1.58. On October 17, 2014, all of the Series T warrants expired. The underwriters received 445,514 Series U warrants to purchase one share of common stock. The Series U warrants were exercisable beginning October 17, 2014, expire on October 17, 2017, and have an exercise price of $1.75. The fair value at issuance of the Series T and U warrants of approximately $470,000 was recorded as a warrant liability.

Series V Warrants

On May 28, 2015, the Company closed an underwritten public offering of 20,253,164 shares of common stock and 20,253,164 Series V warrants to purchase shares of common stock. The common stock and Series V warrants were sold at a combined per unit price of $0.79 for net proceeds of approximately $14.7 million, net of underwriting discounts and commissions and offering expenses. The Series V warrants were immediately exercisable at a price of $0.79 and expire on May 28, 2020. The fair value at issuance of the Series V warrants of approximately $8.0 million was recorded as a warrant liability.

Series W Warrants

On October 28, 2015, the Company closed an underwritten public offering of 17,223,248 shares of common stock and 17,223,248 Series W warrants to purchase shares of common stock. The common stock and warrants were sold at a combined per unit price of $0.67 for net proceeds of approximately $10.5 million, net of underwriting discounts and commissions and offering expenses. The Series W warrants are immediately exercisable at a price of $0.67 and expire on October 28, 2020. The fair value at issuance of the Series W warrants of approximately $5.1 million was recorded as warrant liability.

Series Z and ZZ Warrants

On May 23, 2016, the Company closed a registered direct offering of 10,000,000 shares of common stock and 6,600,000 Series Z warrants to purchase shares of common stock. The common stock and warrants were sold at a combined per unit price of $0.50 for net proceeds of approximately $4.6 million, net of placement agent’s commissions and offering expenses. The Series Z warrants may be exercised at any time on or after November 23, 2016 and on or before November 23, 2021 at a price of $0.55 per share. The Company also issued 500,000 Series ZZ warrants to the placement agent as part of its compensation. The Series ZZ warrants may be exercised at any time on or after November 23, 2016 and on or before May 18, 2021 at a price of $0.55 per share. The fair value of the Series Z and Series ZZ warrants of approximately $2.1 million on the date of issuance was recorded as a warrant liability.

Series AA and BB Warrants

On August 26, 2016, the Company closed a registered direct offering of 10,000,000 shares of common stock and 5,000,000 Series AA warrants to purchase shares of common stock. The common stock and warrants were sold at a combined per unit price of $0.50 for proceeds of approximately $4.5 million, net of placement agent’s commissions and offering expenses. The series AA warrants may be exercised at any time after February 22, 2017 and on or before February 22, 2022 at a price of $0.55 per share. The Company also issued 400,000 Series BB warrants to the placement agent as part of its compensation. The Series BB warrants may be exercised at any time on or after February 22, 2017 and on or before August 22, 2021 at a price of $0.55 per share. The fair value of the Series AA and Series BB warrants of approximately $1.5 million on the date of issuance was recorded as a warrant liability.

2. Equity Warrants

Series X Warrants

In January 2016, the Company sold 3,000,000 shares of its common stock and 3,000,000 Series X warrants to the de Clara Trust for approximately $1.1 million. The de Clara Trust is controlled by Geert Kersten, the Company's Chief Executive Officer and a director. Each Series X warrant allows the de Clara Trust to purchase one share of the Company's common stock at a price of $0.37 per share at any time on or before January 13, 2021. The Series X warrants qualify for equity treatment in accordance with ASC 815. The relative fair value of the warrants was calculated to be approximately $417,000.

Series Y Warrants

On February 15, 2016, the Company sold 1,300,000 shares of its common stock and 650,000 Series Y warrants to a private investor for $624,000. Each Series Y warrant allows the holder to purchase one share of the Company's common stock at a price of $0.48 per share at any time on or before February 15, 2021. The Series Y warrants qualify for equity treatment in accordance with ASC 815. The relative fair value on the date of issuance of the warrants was calculated to be approximately $144,000.

Series N Warrants

Series N warrants were previously issued in connection with a financing. On October 11, 2013 and December 24, 2013, in connection with public offerings of common stock on those dates, the Company reset the exercise price of the 518,771 outstanding Series N warrants from $3.00 to $0.53 and issued the Series N warrant holders 2,432,649 additional warrants exercisable at $0.53, as required by the warrant agreements. In January 2014, the Company offered the investors the option to extend the Series N warrants by one year and allow for cashless exercise in exchange for cancelling the reset provision in the warrant agreement. One investor, holding 2,844,627 Series N warrants accepted this offer. Accordingly, these warrants are no longer considered a derivative liability due to the cancelation of the reset provision. The fair value of the warrants on that date totaled approximately $1.3 million and was reclassified from derivative liabilities to additional paid-in capital. On March 21, 2014, the other investor exercised 106,793 Series N warrants. The Company received cash proceeds of approximately $7,000 for 14,078 of the warrants exercised. The remaining 92,715 warrants were exercised in a cashless exercise. The fair value of the warrants on the date of exercise was $137,000 and was reclassified from derivative liabilities to additional paid-in capital.

On October 28, 2014, the outstanding 2,844,627 Series N Warrants were transferred to the de Clara Trust, of which the Company’s CEO, Geert Kersten, is the trustee and a beneficiary. On June 29, 2015, the Company extended the expiration date of the Series N warrants to August 18, 2017. The incremental cost of this modification was approximately $475,000. The modification was concurrent with the extinguishment and reissuance of a note payable also held in the de Clara Trust, and was recorded as a loss on debt extinguishment.

As of September 30, 2016, the remaining 2,844,627 Series N warrants entitle the holder to purchase one share of the Company's common stock at a price of $0.53 per share at any time prior to August 18, 2017. On September 30, 2016 and 2015, no derivative liability was recorded because the warrants no longer were considered a liability for accounting purposes.

Series L and Series M Warrants

Series L and Series M warrants were previously issued in connection with a financing. In April 2014, 25,000 Series L warrants, with an exercise price of $7.50, expired. In April 2015, the remaining 70,000 of the Series L warrants, which had been repriced to $2.50 in April 2013, expired.

In October 2013, the Company reduced the exercise prices of the Series M warrants from $3.40 to $1.00 in exchange for a reduction in the number of warrants from 600,000 to 500,000. The additional cost of $76,991 was recorded as non-employee stock expense. In March 2014, 500,000 Series M warrants were exercised at a price of $1.00, and the Company received proceeds of $500,000.

Series P Warrants

On February 10, 2012, the Company issued 590,001 Series P warrants to purchase up to 590,001 shares of the Company’s common stock at a price of $4.50 per share as an inducement for the exercise of previously issued warrants. The Series P warrants are exercisable at any time prior to March 6, 2017.

3. Options and Shares Issued to Consultants

The Company typically enters into consulting arrangements in exchange for common stock or stock options. During the years ended September 30, 2016 and 2015, the Company issued 1,248,831 and 739,968 shares of common stock, respectively, to consultants, of which 784,000 and 180,000, respectively, were restricted shares. Under these arrangements, the common stock was issued with stock prices ranging between $0.37 and $1.11 per share.

Additionally, during the years ended September 30, 2016 and 2015, the Company issued to consultants 410,000 and 90,000 options, respectively, to purchase common stock with exercise prices ranging from $0.37 to $1.02 per share and fair values ranging from $0.12 to $0.50 per share. The aggregate values of the issuances of restricted common stock and common stock options are recorded as prepaid expenses and are charged to general and administrative expenses over the periods of service.

During the years ended September 30, 2016 and 2015, the Company recorded total expense of approximately $752,000 and $566,000, respectively, relating to these consulting agreements. At September 30, 2016 and 2015, approximately $48,000 and $30,000, respectively, are included in prepaid expenses. As of September 30, 2016, 640,000 options issued to consultants as payment for services remained outstanding, 440,000 of which are fully vested, and all of which were issued from the Non-Qualified Stock Option plans.

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5. RESEARCH AND OFFICE EQUIPMENT

12 Months Ended

Sep. 30, 2016

Notes to Financial Statements

5. RESEARCH AND OFFICE EQUIPMENT

Research and office equipment consisted of the following at September 30:

	2016			2015
Research equipment	$	3,158,633		$	3,268,757
Furniture and equipment		133,499			141,347
Leasehold improvements		131,910			131,910
		3,424,042			3,542,014
Accumulated depreciation and amortization		(3,197,826	)		(3,234,548	)
Net research and office equipment	$	226,216		$	307,466

Depreciation expense for the years ended September 30, 2016, 2015 and 2014 totaled approximately $112,000, $166,000 and $189,000, respectively. One asset is recorded under capital lease with a net book value of $0 and approximately $8,000 on September 30, 2016 and 2015, respectively. Amortization of the capital lease asset is included in general and administrative expenses on the Statements of Operations.

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6. PATENTS

12 Months Ended

Sep. 30, 2016

Accounting Policies [Abstract]

6. PATENTS

Patents consisted of the following at September 30:

	2016			2015
Patents	$	1,528,610		$	1,525,791
Accumulated amortization		(1,272,063.00	)		(1,234,227.00	)
Net Patents	$	256,547		$	291,564

During the years ended September 30, 2016, 2015 there was no impairment of patent costs and a nominal impairment charge in 2014. Amortization expense for the years ended September 30, 2016, 2015 and 2014 totaled approximately $38,000, $40,000 and $43,000, respectively. The total estimated future amortization is as follows:

Years ending September 30,
2017	$	37,000
2018		36,000
2019		35,000
2020		31,000
2021		28,000
Thereafter		90,000
	$	257,000

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7. INCOME TAXES

12 Months Ended

Sep. 30, 2016

Income Tax Disclosure [Abstract]

7. INCOME TAXES

At September 30, 2016 and 2015, the Company had federal net operating loss carryforwards of approximately $169.7 million and $157.0 million, respectively. The NOLs begin to expire during the fiscal year ending September 30, 2019 and become fully expired by the end of the fiscal year ended 2036. In addition, the Company has a general business credit as a result of the credit for increasing research activities (“R&D credit”) of approximately $1.2 million at September 30, 2016 and 2015. The R&D credit begins to expire during the fiscal year ending September 30, 2020 and is fully expired during the fiscal year ended 2029. Deferred taxes consisted of the following at September 30:

	2016			2015
Net operating loss carryforwards	$	64,366,000		$	61,363,000
R&D credit		1,221,000			1,221,000
Stock-based compensation		6,379,000			5,855,000
Fixed assets and intangibles		57,000			41,000
Capitalized R&D		18,508,000			15,082,000
Vacation and other		179,000			114,000
Loan modification		-			57,000
Total deferred tax assets		90,710,000			83,733,000
Valuation allowance		(90,710,000	)		(83,733,000	)
Net deferred tax asset	$	-		$	-

In assessing the realization of deferred tax assets, management considered whether it was more likely than not that some, or all, of the deferred tax asset will be realized. The ultimate realization of the deferred tax assets is dependent upon the generation of future taxable income. Management has considered the history of the Company’s operating losses and believes that the realization of the benefit of the deferred tax assets cannot be reasonably assured. In addition, under Internal Revenue Code Section 382, the Company’s ability to utilize these net operating loss carryforwards may be limited or eliminated in the event of future changes in ownership.

The Company has no federal or state current or deferred tax expense or benefit. The Company’s effective tax rate differs from the applicable federal statutory tax rate. The reconciliation of these rates is as follows at September 30:

	2016			2015			2014
Federal Rate		34.00	%		34.00	%		34.00	%
State tax rate, net of federal benefit		3.92			5.12			5.15
State tax rate change		(22.13	)		(0.15	)		(0.93	)
Other adjustments		(0.03	)		(0.21	)		0.00
Adjustment to deferreds		0.00			0.00			19.13
Permanent differences (1)		45.08			(0.71	)		(0.43	)
Change in valuation allowance		(60.84	)		(38.05	)		(58.78	)
Effective tax rate		0.00	%		0.00	%		0.00	%

(1) The 2016 amount is mainly due to the gain on derivative instruments approximating $14 million from the change in fair value of the Company’s warrant liabilities during the year.

The Company applies the provisions of ASC 740, “Accounting for Uncertainty in Income Taxes,” which requires financial statement benefits to be recognized for positions taken for tax return purposes when it is more likely than not that the position will be sustained. The Company has elected to reflect any tax penalties or interest resulting from tax assessments on uncertain tax positions as a component of tax expense. The Company has generated federal net operating losses in tax years ending September 30, 1998 through 2015. These years remain open to examination by the major domestic taxing jurisdictions to which the Company is subject.

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8. STOCK COMPENSATION

12 Months Ended

Sep. 30, 2016

Disclosure of Compensation Related Costs, Share-based Payments [Abstract]

8. STOCK COMPENSATION

The Company recognized the following expenses for options issued or vested and restricted stock awarded during the year:

	Year Ended September 30,
	2016		2015		2014
Employees	$	2,113,433	$	5,105,827	$	3,958,637
Non-employees	$	751,651	$	565,915	$	771,946

These expenses were recorded as general and administrative expense. During the years ended September 30, 2016, 2015 and 2014, non-employee stock compensation excluded approximately $48,000, $30,000 and $26,000, respectively, for future services to be performed (Note 12).

During the years ended September 30, the fair value of each option grant was estimated on the date of grant using the Black-Scholes option-pricing model with the following assumptions.

	2016	2015	2014
Expected stock price volatility	75.58 – 80.9%	73.38 – 86.19%	72.81 – 86.87%
Risk-free interest rate	0.71 – 1.56%	0.93 – 2.35%	0.59 – 2.65%
Expected life of options	3.0 – 9.69 Years	3.0 – 9.76 Years	3.0 – 9.76 Years
Expected dividend yield	-	-	-

Non-Qualified Stock Option Plans--At September 30, 2016, the Company has collectively authorized the issuance of 9,680,000 shares of common stock under its Non-Qualified Stock Option Plans. Options typically vest over a three-year period and expire no later than ten years after the grant date. Terms of the options are to be determined by the Company’s Compensation Committee, which administers the plans. The Company’s employees, directors, officers, and consultants or advisors are eligible to be granted options under the Non-Qualified Stock Option Plans.

Incentive Stock Option Plans--At September 30, 2016, the Company had collectively authorized the issuance of 3,460,000 shares of common stock under its Incentive Stock Option Plans. Options typically vest over a three-year period and expire no later than ten years after the grant date. Terms of the options were determined by the Company’s Compensation Committee, which administers the plans. Only the Company’s employees are eligible to be granted options under the Incentive Stock Option Plans.

Activity in the Company’s Non-Qualified and Incentive Stock Option Plans for the two years ended September 30, 2016 is summarized as follows:

Non-Qualified and Incentive Stock Option Plans

		Outstanding								Exercisable
						Weighted								Weighted
						Ave								Ave
		Number of		Weighted Average		Remaining Contractual		Aggregate Intrinsic		Number of		Weighted Average		Remaining Contractual		Aggregate Intrinsic
		Shares		Exercise Price		Term (Years)		Value		Shares		Exercise Price		Term (Years)		Value
Outstanding at October 1, 2014			6,831,149	$	2.98		6.55	$	3,600		3,443,884	$	3.40		5.49	$	3,600
Vested											1,153,357	$	2.48
Granted (a)			893,700	$	0.66
Forfeited			116,665	$	1.87
Expired			70,499	$	4.15						70,499	$	4.15
Outstanding at September 30, 2015			7,537,685	$	2.71		5.98	$	50		4,526,742	$	3.15		5.01	$	0
Vested											1,401,716	$	1.27
Granted (b)			1,213,600	$	0.48
Forfeited			55,998	$	0.86
Expired			106,000	$	5.80						106,000	$	5.80
Outstanding at September 30, 2016			8,589,287	$	2.37		5.35	$	0		5,822,458	$	2.65		4.76	$	0
(a)	Includes 90,000 stock options granted to consultants

(b) Includes 410,000 stock options granted to consultants

A summary of the status of the Company’s non-vested options for the two years ended September 30, 2016 is presented below:

				Weighted Average
	Number of			Grant Date
	Options			Fair Value
Unvested at October 1, 2014		3,387,265		$	2.15
Vested		(1,153,357	)
Granted		893,700
Forfeited		(116,665	)
Unvested at September 30, 2015		3,010,943		$	1.72
Vested		(1,401,716	)
Granted		1,213,600
Forfeited		(55,998	)
Unvested at September 30, 2016		2,766,829		$	1.48

Incentive Stock Bonus Plan-- On July 22, 2014 the Company's shareholders approved the 2014 Incentive Stock Bonus Plan, authorizing the issuance of up to 16,000,000 shares in the Company’s Incentive Stock Bonus Plan. The shares will only be earned upon the achievement of certain milestones leading to the commercialization of the Company’s Multikine technology, or specified increases in the market price of the Company’s stock. If the performance or market criteria are not met as specified in the Incentive Stock Bonus Plan, all or a portion of the awarded shares will be forfeited. The fair value of the shares on the grant date was calculated using the market value on the grant-date for issuances where the attainment of performance criteria is likely and using a Monte Carlo simulation for issuances where the attainment of performance criteria is uncertain. The grant date fair value of shares issued that remain outstanding as of September 30, 2016 is approximately $8.6 million. The total value of the shares, if earned, is being expensed over the requisite service periods for each milestone, provided the requisite service periods are rendered, regardless of whether the market conditions are met. No compensation cost is recognized for awards where the requisite service period is not rendered. During the years ended September 30, 2016 and 2015, the Company recorded expense relating to the issuance of restricted stock pursuant to the plan of approximately $634,000 and $3.4 million, respectively. At September 30, 2016, the Company has unrecognized compensation expense of approximately $3.1 million which is expected to be recognized over a weighted average period of 5.03 years.

A summary of the status of the Company’s restricted stock units issued from the Incentive Stock Bonus Plan for the two years in the period ended September 30, 2016 is presented below:

	Number of Shares			Weighted Average Grant Date Fair Value
Unvested at October 1, 2014		15,700,000		$	0.55
Vested		(500,000	)
Granted		-
Forfeited		(100,000	)
Unvested at September 30, 2015		15,100,000		$	0.55
Vested		-
Unvested at September 30, 2016		15,100,000		$	0.55

Stock Bonus Plans -- At September 30, 2016, the Company was authorized to issue up to 5,594,000 shares of common stock under its Stock Bonus Plans. All employees, directors, officers, consultants, and advisors are eligible to be granted shares. During the year ended September 30, 2016, 408,497 shares were issued to the Company’s 401(k) plan for a cost of approximately $162,000. During the year ended September 30, 2015, 243,178 shares were issued to the Company’s 401(k) plan for a cost of approximately $166,000. During the year ended September 30, 2014, 164,787 shares were issued to the Company’s 401(k) plan for a cost of approximately $155,000. As of September 30, 2016, the Company has issued a total of 3,161,211 shares of common stock from the Stock Bonus Plans.

Stock Compensation Plans-- At September 30, 2016, 3,350,000 shares were authorized for use in the Company’s stock compensation plans. During the years ended September 30, 2016, 2015 and 2014, 464,831, 218,328 and 409,968 shares, respectively, were issued from the Stock Compensation Plans to consultants for payment of services at a cost of approximately $234,000, $147,000 and $439,000, respectively. During the year ended September 30, 2016 and 2015, 95,935 and 107,050 shares, respectively, were issued to employees from the Stock Compensation Plans as part of their compensation at a cost of approximately $45,000 and $58,000, respectively. No shares were issued to employees from the Stock Compensation Plans during the year ended September 30, 2014. As of September 30, 2016, the Company has issued 1,984,765 shares of common stock from the Stock Compensation Plans.

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9. EMPLOYEE BENEFIT PLAN

12 Months Ended

Sep. 30, 2016

Compensation and Retirement Disclosure [Abstract]

9. EMPLOYEE BENEFIT PLAN

The Company maintains a defined contribution retirement plan, qualifying under Section 401(k) of the Internal Revenue Code, subject to the Employee Retirement Income Security Act of 1974, as amended, and covering substantially all Company employees. Each participant’s contribution is matched by the Company with shares of common stock that have a value equal to 100% of the participant’s contribution, not to exceed the lesser of $10,000 or 6% of the participant’s total compensation. The Company’s contribution of common stock is valued each quarter based upon the closing bid price of the Company’s common stock. Total expense, including plan maintenance, for the years ended September 30, 2016, 2015 and 2014, in connection with this Plan was approximately $168,000, $170,000 and $160,000, respectively.

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10. COMMITMENTS AND CONTINGENCIES

12 Months Ended

Sep. 30, 2016

Commitments and Contingencies Disclosure [Abstract]

10. COMMITMENTS AND CONTINGENCIES

Clinical Research Agreements

In March 2013, the Company entered into an agreement with Aptiv Solutions to provide certain clinical research services in accordance with a master service agreement. The Company will reimburse Aptiv for costs incurred. The agreement required the Company to make $600,000 in advance payments which are being credited against future invoices in $150,000 annual increments through December 2017. As of September 30, 2016, the total balance advanced is $300,000, of which $150,000 is classified as a current asset.

In April 2013, the Company entered into a co-development and revenue sharing agreement with Ergomed. Under the agreement, Ergomed will contribute up to $10 million towards the study in the form of offering discounted clinical services in exchange for a single digit percentage of milestone and royalty payments, up to a specific maximum amount. In October 2015, the Company entered into a second co-development and revenue sharing agreement with Ergomed for an additional $2 million, for a total of $12 million. The Company accounted for the co-development and revenue sharing agreement in accordance with ASC 808 “Collaborative Arrangements”. The Company determined the payments to Ergomed are within the scope of ASC 730 “Research and Development.” Therefore, the Company records the discount on the clinical services as a credit to research and development expense on its Statements of Operations. Since the Company entered into the co-development and revenue sharing agreement with Ergomed, it has incurred research and development expenses of approximately $19.2 million related to Ergomed’s services. This amount is net of Ergomed’s discount of approximately $6.3 million. During the years ended September 30, 2016, 2015 and 2014, the Company recorded, approximately $7.2 million, $6.7 million and $4.4 million, respectively, as research and development expense related to Ergomed’s services. These amounts were net of Ergomed’s discount of approximately $2.1 million, $2.4 million and $1.5 million, respectively, over the comparable periods.

In October 2013, the Company entered into two co-development and profit sharing agreements with Ergomed.  One agreement supports the Phase 1 study being conducted at UCSF for the development of Multikine as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women.  The other agreement focuses on the development of Multikine as a potential treatment for cervical dysplasia in HIV/HPV co-infected women. Ergomed will assume up to $3 million in clinical and regulatory costs for each study.

The Company is currently involved in a pending arbitration proceeding, CEL-SCI Corporation v. inVentiv Health Clinical, LLC (f/k/a PharmaNet LLC) and PharmaNet GmbH (f/k/a PharmaNet AG). On October 31, 2013, the Company initiated the proceedings against inVentiv Health Clinical, LLC, or inVentiv, the former third-party CRO, and are seeking payment for damages related to inVentiv’s prior involvement in the ongoing Phase 3 clinical trial of Multikine. The arbitration claim, initiated under the Commercial Rules of the American Arbitration Association, alleges (i) breach of contract, (ii) fraud in the inducement, and (iii) common law fraud. The Company is seeking at least $50 million in damages in its amended statement of claim. Based upon further analysis, however, the Company believes that its damages (direct and consequential) presently total over $150 million. 

In an amended statement of claim, the Company asserted the claims set forth above as well as an additional claim for professional malpractice.  The arbitrator subsequently granted inVentiv’s motion to dismiss the professional malpractice claim based on the “economic loss doctrine” which, under New Jersey law, is a legal doctrine that, under certain circumstances, prohibits bringing a negligence-based claim alongside a claim for breach of contract.  The arbitrator denied the remainder of inVentiv’s motion, which had sought to dismiss certain other aspects of the amended statement of claim.  In particular, the arbitrator rejected inVentiv’s argument that several aspects of the amended statement of claim were beyond the arbitrator’s jurisdiction.

In connection with the pending arbitration proceedings, inVentiv has asserted counterclaims against the Company for (i) breach of contract, seeking at least $2 million in damages for services allegedly performed by inVentiv; (ii) breach of contract, seeking at least $1 million in damages for the Company’s alleged use of inVentiv’s name in connection with publications and promotions in violation of the parties’ contract; (iii) opportunistic breach, restitution and unjust enrichment, seeking at least $20 million in disgorgement of alleged unjust profits allegedly made by the Company as a result of the purported breaches referenced in subsection (ii); and (iv) defamation, seeking at least $1 million in damages for allegedly defamatory statements made about inVentiv. The Company believes inVentiv’s counterclaims are meritless. However, if inVentiv successfully asserts any of its counterclaims, such an adverse determination could have a material adverse effect on the Company’s business, results, financial condition and liquidity.

In October 2015 the Company signed an arbitration funding agreement with a company established by Lake Whillans Litigation Finance, LLC, a firm specializing in funding litigation expenses. Pursuant to the agreement, an affiliate of Lake Whillans provides the Company with funding for litigation expenses to support its arbitration claims against inVentiv. The funding is available to the Company to fund the expenses of the ongoing arbitration and will only be repaid when the Company receives proceeds from the arbitration. During the year ended September 30, 2016, the Company recognized a gain of approximately $1.1 million on the derecognition of legal fees to record the transfer of the liability that existed prior to the execution of the financing agreement from the Company to Lake Whillans. The gain on derecognition of legal fees is recorded as a reduction of general and administration expenses on the Statement of Operations. All related legal fees are directly billed to and paid by Lake Whillans. As part of the agreement with Lake Whillans, the law firm agreed to cap its fees and expenses for the arbitration at $5 million.

The arbitration hearing on the merits (the “trial”) began on September 26, 2016.

Lease Agreements

The approximate future minimum annual rental payments due under non-cancelable operating leases for office and laboratory space are as follows:

Years Ending September 30,
2017	$	1,930,000
2018		1,997,000
2019		2,066,000
2020		2,110,000
2021		2,100,000
Thereafter		15,831,000
Total minimum lease payments:	$	26,034,000

Rent expense, including amortization of deferred rent, for the years ended September 30, 2016, 2015 and 2014, was approximately $2.7 million. The Company’s three leases expire between June 2020 and October 2028.

The Company leases a building near Baltimore, Maryland. The building was remodeled in accordance with the Company’s specifications so that it can be used by the Company to manufacture Multikine for the Company’s Phase 3 clinical trial and sales of the drug if approved by the FDA. The lease is for a term of twenty years and requires annual base rent to escalate each year at 3%. The Company is required to pay all real estate and personal property taxes, insurance premiums, maintenance expenses, repair costs and utilities. The lease allows the Company, at its election, to extend the lease for two ten-year periods or to purchase the building at the end of the 20-year lease.

At September 30, 2016, the Company recorded a total deferred rent asset of approximately $3.8 million, of which approximately $3.4 million is long term and the balance of approximately $430,000 is included in current assets. At September 30, 2015, the Company recorded a total deferred rent asset of approximately $4.5 million, of which approximately $4 million is long term and the balance of approximately $488,000 is included in current assets. On September 30, 2016 and 2015, the Company has included in deferred rent the following: 1) deposit on the manufacturing facility ($3.1 million); 2) the fair value of the warrants issued to lessor ($1.4 million); 3) additional investment ($3.0); 4) deposit on the cost of the leasehold improvements for the manufacturing facility ($1.8 million). At September 30, 2016, the Company has accumulated amortization of approximately $5.5 million. At September 30, 2015, the Company has also included accrued interest on deposit of approximately $128,000, and accumulated amortization of approximately $4.9 million.

The Company was required to deposit the equivalent of one year of base rent in accordance with the lease. When the Company meets the minimum cash balance required by the lease, the deposit will be returned to the Company. The approximate $1.7 million deposit is included in non-current assets on September 30, 2016 and 2015.

The Company subleases a portion of its rental space on a month to month term lease, which requires a 30 day notice for termination. The sublease rent for the years ended September 30, 2016, 2015 and 2014 was approximately $67,000, $65,000 and $63,000, respectively, and is recorded in grant income and other in the statements of operations.

The Company leases its research and development laboratory under a 60 month lease which expires February 28, 2017. In September 2016, the lease was extended through February 28, 2022. The operating lease includes escalating rental payments. The Company is recognizing the related rent expense on a straight line basis over the full 60 month term of the lease at the rate of approximately $11,000 per month. As of September 30, 2016 and 2015, the Company has recorded a deferred rent liability of approximately $2,000 and $6,000, respectively.

The Company leases its office headquarters under a 60 month lease which expires June 30, 2020. The operating lease includes escalating rental payments. The Company is recognizing the related rent expense on a straight line basis over the full 60 month term of the lease at the rate approximately $8,000 per month. As of September 30, 2016 and 2015, the Company has recorded a deferred rent liability of approximately $18,000 and $13,000, respectively.

The Company leases office equipment under a capital lease arrangement. The term of the capital lease is 48 months and expired on September 30, 2016. The monthly lease payment is $1,025. The lease bears interest at approximately 6% per annum.

Vendor Obligations

Further, the Company has contingent obligations with other vendors for work that will be completed in relation to the Phase 3 trial. The timing of these obligations cannot be determined at this time. The Company estimates that the total remaining cash cost of the Phase 3 clinical trial, excluding any costs that will be paid by CEL’SCI’s partners, would be approximately $12.1 million after September 30, 2016. This is based on the executed contract costs with the CROs only and does not include other related costs, e.g. the manufacturing of the drug. The Company has filed an amendment to the original Phase 3 protocol for it head and neck cancer study with the FDA to allow for this expansion in patient enrollment. Should the FDA allow the amended protocol filed with them to proceed, the remaining cost of the Phase 3 clinical trial will be higher.

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11. RELATED PARTY TRANSACTIONS

12 Months Ended

Sep. 30, 2016

Related Party Transactions [Abstract]

11. RELATED PARTY TRANSACTIONS

Effective August 31, 2016, Maximilian de Clara, the Company’s President and a director, resigned for health reasons. In payment for past services, the Company agreed to issue Mr. de Clara 650,000 shares of restricted stock; 325,000 shares upon his resignation and 325,000 on August 31, 2017. The market value of the shares granted, including the accrued value of the shares to be issued in August 2017, totaled $253,500.

On January 13, 2016, the de Clara Trust demanded payment on the note payable, of which the balance, including accrued and unpaid interest, was $1,105,989. The de Clara Trust was established by Maximilian de Clara, the Company’s former President and a director. The Company’s Chief Executive Officer, Geert Kersten, is the trustee and a beneficiary. When the de Clara Trust demanded payment on the note, the Company sold 3,000,000 shares of its common stock and 3,000,000 Series X warrants to the de Clara Trust for approximately $1.1 million. Each warrant allows the de Clara Trust to purchase one share of the Company's common stock at a price of $0.37 per share at any time on or before January 13, 2021.

Prior to the repayment, on June 29, 2015, the Company had extended the maturity date of the note to July 6, 2017, lowered the interest rate from 15% to 9% and changed the conversion price from $4.00 to $0.59, the closing stock price on the previous trading day. The Company determined these modifications to be substantive and accounted for the modification as an extinguishment of the pre-modification note and issuance of the post-modification note. The Company recorded an extinguishment loss and a premium on the note payable of approximately $166,000, which was credited to additional paid in capital. Concurrently, the Company extended the expiration date of the Series N warrants to August 18, 2017. The incremental cost of this modification was approximately $475,000 and was included in debt extinguishment loss on the note, for a total loss of approximately $620,000 during the year ended September 30, 2015.

During the years ended September 30, 2016, 2015 and 2014, the Company paid approximately $43,000, $146,000 and $179,000, respectively, in interest expense to Mr. de Clara.

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12. STOCKHOLDERS EQUITY

12 Months Ended

Sep. 30, 2016

Notes to Financial Statements

12. STOCKHOLDERS' EQUITY

During the years ended September 30, 2016 and 2015, no warrants were exercised. During the year ended September 30, 2014, 2,695,562 Series M, N and S warrants were exercised. The Company issued 2,668,508 shares of common stock and received approximately $3.1 million from the exercise of these warrants since 92,715 Series N warrants were exercised in a cashless exercise.

On October 11, 2013, the Company closed a public offering of units of common stock and Series S warrants at a price of $1.00 per unit for net proceeds of $16.4 million, net of underwriting discounts and commissions. Each unit consisted of one share of common stock and a warrant to purchase one share of common stock. The warrants were immediately exercisable and expire on October 11, 2018, and have an exercise price of $1.25. In November 2013, the underwriters purchased an additional 2,648,913 warrants pursuant to the overallotment option, for which the Company received net proceeds of approximately $24,000.

On December 24, 2013, the Company closed a public offering of units of common stock and Series S warrants at a price of $0.63 per unit for net proceeds of approximately $2.8 million, net of underwriting discounts and commissions. Each unit consisted of one share of common stock and a warrant to purchase one share of common stock. The warrants are immediately exercisable and expire on October 11, 2018, and have an exercise price of $1.25. The underwriters exercised the option for the full 10% overallotment, for which the Company received net proceeds of approximately $279,000.

The October and December 2013 financings triggered the reset provision from the August 2008 financing which resulted in the issuance of an additional 1,563,083 shares of common stock. The cost of additional shares issued was approximately $1.1 million. This cost was recorded as a deemed a dividend. 

On October 24, 2014, the Company closed an underwritten public offering of 7,894,737 shares of common stock and 1,973,684 Series S warrants to purchase shares of common stock. Additionally, in a related private offering on October 21, 2014, the Company sold 1,320,000 shares of common stock and 330,000 Series S warrants to purchase shares of common stock. The common stock and Series S warrants were sold at a combined price of $0.76 for net proceeds of approximately $6.4 million, net of offering expenses. The Series S warrants trade of the NYSE MKT under the symbol CVM WT.

On April 17, 2014, the Company closed a public offering of units consisting of 7,128,229 shares of common stock and Series T warrants to purchase an aggregate of 1,782,057 shares of common stock. The units were sold at a price of $1.40 per unit. The Company received net proceeds of approximately $9.1 million after deducting the underwriting commissions and offering expenses. The common stock and warrants separated immediately. The Series T warrants, with an exercise price of $1.58 per share, expired on October 17, 2014. The underwriters in the offering received 445,514 Series U warrants to purchase one share of common stock. The Series U warrants expire on October 17, 2017, and have an exercise price of $1.75.

On May 28, 2015, the Company closed an underwritten public offering of 20,253,164 shares of common stock and 20,253,164 Series V warrants to purchase shares of common stock. The common stock and Series V warrants were sold at a combined per unit price of $0.79 for net proceeds of approximately $14.7 million, net of underwriting discounts and commissions and offering expenses. The Series V warrants are immediately exercisable at a price of $0.79 and expire on May 28, 2020.

On October 28, 2015, the Company closed an underwritten public offering of 17,223,248 shares of common stock and 17,223,248 Series W warrants to purchase shares of common stock. The common stock and warrants were sold at a combined price of $0.67 for net proceeds of approximately $10.5 million, net of underwriting commissions and offering expenses. The warrants were immediately exercisable, expire October 28, 2020 and have an exercise price of $0.67.

On May 23, 2016, the Company closed a registered direct offering of 10,000,000 shares of common stock and 6,600,000 Series Z warrants to purchase shares of common stock. The common stock and warrants were sold at a combined per unit price of $0.50 for net proceeds of approximately $4.6 million, net of placement agent’s commissions and offering expenses. The Series Z warrants may be exercised at any time on or after November 23, 2016 and on or before November 23, 2021 at a price of $0.55 per share. The Company also issued 500,000 Series ZZ warrants to the placement agent as part of its compensation. The Series ZZ warrants may be exercised at any time on or after November 23, 2016 and on or before May 18, 2021 at a price of $0.55 per share.

On August 26, 2016, the Company closed a registered direct offering of 10,000,000 shares of common stock and Series AA warrants to purchase up to 5,000,000 shares of common stock. Each share of common stock was sold together with a Series AA warrant to purchase one-half of a share of common stock for the combined purchase price of $0.50. Each warrant can be exercised at any time after February 22, 2017 and on or before February 22, 2022 at a price of $0.55 per share. The Company also issued 400,000 Series BB warrants to the placement agent as part of its compensation. The Series BB warrants may be exercised at any time on or after February 22, 2017 and on or before August 22, 2021 at a price of $0.55 per share. The Company received proceeds from the sale of Series AA and Series BB shares and warrants of approximately $4.5 million, net of placement agent’s commissions and offering expenses

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13. FAIR VALUE MEASUREMENTS

12 Months Ended

Sep. 30, 2016

Fair Value Disclosures [Abstract]

13. FAIR VALUE MEASUREMENTS

In accordance with the provisions of ASC 820, “Fair Value Measurements,” the Company determines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The Company generally applies the income approach to determine fair value. This method uses valuation techniques to convert future amounts to a single present amount. The measurement is based on the value indicated by current market expectations about those future amounts.

ASC 820 establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to active markets for identical assets and liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The Company classifies fair value balances based on the observability of those inputs. The three levels of the fair value hierarchy are as follows:

o Level 1 – Observable inputs such as quoted prices in active markets for identical assets or liabilities

o Level 2 – Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and amounts derived from valuation models where all significant inputs are observable in active markets

o Level 3 – Unobservable inputs that reflect management’s assumptions

For disclosure purposes, assets and liabilities are classified in their entirety in the fair value hierarchy level based on the lowest level of input that is significant to the overall fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the placement within the fair value hierarchy levels.

The table below sets forth the liabilities measured at fair value on a recurring basis, by input level, on the balance sheet at September 30, 2016:

	Quoted Prices in	Significant
	Active Markets for	Other	Significant
	Identical Assets or	Observable	Unobservable
	Liabilities (Level 1)	Inputs (Level 2)	Inputs (Level 3)	Total
Derivative Instruments	$3,111,361	-	$5,283,573	$8,394,934

The table below sets forth the liabilities measured at fair value on a recurring basis, by input level, on the balance sheet at September 30, 2015:

	Quoted Prices in	Significant
	Active Markets for	Other	Significant
	Identical Assets or	Observable	Unobservable
	Liabilities (Level 1)	Inputs (Level 2)	Inputs (Level 3)	Total
Derivative Instruments	$7,365,555		$6,323,032	$13,686,587

The following sets forth the reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3), as of September 30:

	2016			2015
Beginning balance	$	6,323,032		$	307,894
Issuances		8,722,073			8,003,220
Net realized and unrealized derivative gain		(9,761,532	)		(1,988,082	)
Ending balance	$	5,283,573			$6,323,032

The fair values of the Company’s derivative instruments disclosed above under Level 3 are primarily derived from valuation models where significant inputs such as historical price and volatility of the Company’s stock as well as U.S. Treasury Bill rates are observable in active markets. At September 30, 2016, the Company’s Level 3 derivative instruments have a weighted average fair value of $0.10 per share and a weighted average exercise price of $0.86 per share. Fair values were determined using a weighted average risk free interest rate of 1.04% and 75% volatility.

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14. NET LOSS PER COMMON SHARE

12 Months Ended

Sep. 30, 2016

Accounting Policies [Abstract]

14. NET LOSS PER COMMON SHARE

Basic loss per share is computed by dividing net loss available to common shareholders by the weighted average number of common shares outstanding during the period. The Company’s potentially dilutive shares, which include outstanding common stock options, common stock warrants, restricted stock and shares issuable on convertible debt, have not been included in the computation of diluted net loss per share for all periods presented, as the result would be anti-dilutive. For the years presented, the gain on derivative instruments is not included in net loss available to common shareholders for purposes of computing dilutive loss per share because its effect is anti-dilutive.

The following table provides a reconciliation of the numerators and denominators of the basic and diluted per-share computations:

	2016			2015			2014
Net loss available to
common shareholders	$	(11,466,498	)	$	(34,674,646	)	$	(28,483,712	)
Less: Gain on derivative
Instruments		-			-			(248,767)
Net loss - diluted	$	(11,466,498	)	$	(34,674,646	)	$	(28,732,479	)
Weighted average number of
shares - basic and diluted		121,655,108			82,519,027			58,804,622
Loss per share - basic	$	(0.09	)	$	(0.42	)	$	(0. 48	)
Loss per share - diluted	$	(0.09	)	$	(0.42	)	$	(0. 49	)

For the years ended September 30, 2016 and 2015, the gain on derivatives is not excluded from the numerator in calculating diluted loss per share because the gain relates to derivative warrants that were priced higher than the average market price during the period.

In accordance with the contingently issuable shares guidance of FASB ASC Topic 260, Earnings Per Share, the calculation of diluted net loss per share excludes the following dilutive securities because their inclusion would have been anti-dilutive as of September 30:

	2016		2015		2014
Options and Warrants		91,882,022		58,421,058		39,994,707
Convertible Debt		-		1,871,283		276,014
Unvested Restricted Stock		15,100,000		15,100,000		15,700,000
Total		106,982,022		75,392,341		55,970,721

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15. SEGMENT REPORTING

12 Months Ended

Sep. 30, 2016

Segment Reporting [Abstract]

15. SEGMENT REPORTING

ASC 280, “Disclosure about Segments of an Enterprise and Related Information” establishes standards for reporting information regarding operating segments in annual financial statements and requires selected information for those segments to be presented in interim financial reports issued to stockholders. This topic also establishes standards for related disclosures about products and services and geographic areas. Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions how to allocate resources and assess performance. The Company’s chief decision maker, as defined under this topic, is the Chief Executive Officer. To date, the Company has viewed its operations as principally one segment, the research and development of certain drugs and vaccines. As a result, the financial information disclosed herein materially represents all of the financial information related to the Company’s principal operating segment.

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16. QUARTERLY INFORMATION (UNAUDITED)

12 Months Ended

Sep. 30, 2016

Quarterly Financial Information Disclosure [Abstract]

16. QUARTERLY INFORMATION (UNAUDITED)

The following quarterly data are derived from the Company’s statements of operations.

Financial Data

Fiscal 2016
	Three months		Three months			Three months			Three months
	ended		ended			ended			Ended			Year ended
	December 31 2015		March 31, 2016			June 30, 2016			September 30, 2016			September 30, 2016
Grant income and other	$	20,976	$	32,775		$	129,975		$	101,329		$	285,055
Operating expenses		5,804,108		6,306,378			6,512,722			7,215,072			25,838,280
Non-operating (expense) income, net		1,985		22,478			24,679			23,859			73,001
Gain (loss) on derivative instruments		8,122,960		(2,593,730	)		2,508,744			5,975,752			14,013,726
Net income (loss) available to
common shareholders	$	2,341,813	$	(8,844,855	)	$	(3,849,324	)	$	(1,114,132	)	$	(11,466,498	)
EPS (LPS) -basic and diluted	$	0.02	$	(0.07	)	$	(0.03	)	$	(0.01	)	$	(0.09	)
Weighted average shares:
Basic		109,768,502		118,420,327			124,132,500			134,290,870			121,655,108
Diluted		111,639,785		118,420,327			124,132,500			134,290,870			121,655,108

Fiscal 2015
	Three months			Three months			Three months			Three months
	ended			ended			ended			Ended			Year ended
	December 31 2014			March 31, 2015			June 30, 2015			September 30, 2015			September 30, 2015
Grant income and other	$	136,838		$	197,620		$	389,223		$	(66,304	)	$	657,377
Operating expenses		10,132,579			7,956,963			8,590,698			8,273,682			34,953,922
Non-operating (expense) income, net		(12,547	)		(14,097	)		(35,985	)		22,369			(40,260	)
Gain (loss) on derivative instruments		2,162,970			(4,782,796	)		4,428,780			(1,526,338	)		282,616
Loss on debt extinguishment		-			-			(620,457	)		-			(620,457	)
Net loss available to
common shareholders	$	(7,845,318	)	$	(12,556,236	)	$	(4,429,137	)	$	(9,843,955	)	$	(34,674,646	)
Net loss per share-basic	$	(0.11	)	$	(0.17	)	$	(0.05	)	$	(0.10	)	$	(0.42	)
Net loss per share-diluted	$	(0.14	)	$	(0.17	)	$	(0.06	)	$	(0.10	)	$	(0.42	)
Weighted average shares:
Basic		73,260,783			75,847,869			83,796,311			97,040,004			82,519,027
Diluted		73,260,783			75,847,869			85,134,107			97,040,004			82,519,027

The Company has experienced large swings in its quarterly gains and losses caused by the changes in the fair value of warrants each quarter.

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17. SUBSEQUENT EVENTS

12 Months Ended

Sep. 30, 2016

Subsequent Events [Abstract]

17. SUBSEQUENT EVENTS

In accordance with ASC 855, “Subsequent Events”, the Company has reviewed subsequent events through the date of the filing.

On December 8, 2016, the Company sold 34,024,000 shares of common stock and warrants to purchase common stock at a price of $0.125 in a public offering. The warrants consist of 17,012,000 Series CC warrants to purchase 17,012,000 shares of common stock, 34,024,000 Series DD warrants to purchase 34,024,000 shares of common stock and 34,024,000 Series EE warrants to purchase 34,024,000 shares of common stock. The Series CC warrants are immediately exercisable, expire in five-years and have an exercise price of $0.20 per share. The Series DD warrants are immediately exercisable, expire in six-months and have an exercise price of $0.18 per share. The Series EE warrants are immediately exercisable, expire in nine-months and have an exercise price of $0.18 per share. In addition, the Company issued 1,701,000 Series FF warrants to purchase 1,701,000 shares of common stock to the placement agent. The FF warrants are exercisable at any time on or after June 8, 2017 and expire on December 1, 2021 and have an exercise price $0.15625. The net proceeds to CEL-SCI from this offering was approximately $3.8 million, excluding any future proceeds that may be received from the exercise of the warrants.

On December 9, 2016, the Company reported on a communication received from the staff of the NYSE MKT, its current listing exchange, that it considered the Company to be noncompliant with certain listing requirements based on its quarterly report for the period ended June 30, 2016. The Company has been given the opportunity to maintain its listing by submitting a plan of compliance by January 9, 2017. This plan must advise of actions the company has taken or will take to regain compliance with the continued listing standards by June 11, 2018. The Company intends to submit such a plan by January 9, 2017. The communication and compliance plan has no current effect on the listing of the Company's shares on the exchange. If the plan is not acceptable or the Company does not make sufficient progress under the plan or reestablish compliance by June 11, 2018, then staff of the exchange may initiate proceedings for delisting from the NYSE MKT. The Company may then appeal a staff determination to initiate such proceedings in accordance with the exchange's Company Guide.

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2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (POLICIES)

12 Months Ended

Sep. 30, 2016

Summary Of Significant Accounting Policies Policies

Cash and Cash Equivalents

For purposes of the statements of cash flows, cash and cash equivalents consist principally of unrestricted cash on deposit and short-term money market funds. The Company considers all highly liquid investments with a maturity when purchased of less than three months as cash and cash equivalents.

Prepaid Expenses

Prepaid expenses are payments for future services to be rendered and are expensed over the time period for which the service is rendered. Prepaid expenses may also include payment for goods to be received within one year of the payment date.

Inventory

Inventory consists of manufacturing production advances and bulk purchases of laboratory supplies to be consumed in the manufacturing of the Company’s product for clinical studies. Inventories are stated at the lower of cost or market, where cost is determined using the first-in, first out method applied on a consistent basis.

Deposits

The deposits are required by the lease agreement for the manufacturing facility and by the clinical research organization (CRO) agreements.

Research and Office Equipment and Leasehold Improvements

Research and office equipment is recorded at cost and depreciated using the straight-line method over estimated useful lives of five to seven years. Leasehold improvements are depreciated over the shorter of the estimated useful life of the asset or the term of the lease. Repairs and maintenance which do not extend the life of the asset are expensed when incurred. The fixed assets are reviewed on a quarterly basis to assess impairment, if any.

Patents

Patent expenditures are capitalized and amortized using the straight-line method over the shorter of the expected useful life or the legal life of the patent (17 years). In the event changes in technology or other circumstances impair the value or life of the patent, appropriate adjustment to the asset value and period of amortization is made. An impairment loss is recognized when estimated future undiscounted cash flows expected to result from the use of the asset, and from disposition, are less than the carrying value of the asset. The amount of the impairment loss would be the difference between the estimated fair value of the asset and its carrying value.

Deferred Rent (Asset)

Consideration paid, including deposits, related to operating leases is recorded as a deferred rent asset and amortized as rent expense over the lease term. Interest on the deferred rent is calculated at 3% on the funds deposited on the manufacturing facility and is included in deferred rent. This interest income will be used to offset future rent.

Deferred Rent (Liability)

Certain of the Company’s operating leases provide for minimum annual payments that adjust over the life of the lease.  The aggregate minimum annual payments are expensed on a straight-line basis over the minimum lease term. The Company recognizes a deferred rent liability for rent escalations when the amount of straight-line rent exceeds the lease payments, and reduces the deferred rent liability when the lease payments exceed the straight-line rent expense.  For tenant improvement allowances and rent holidays, the Company records a deferred rent liability and amortizes the deferred rent over the lease term as a reduction to rent expense.

Derivative Instruments

The Company has entered into financing arrangements that consist of freestanding derivative instruments that contain embedded derivative features, specifically, the settlement provisions in the warrant agreements preclude the warrants from being treated as equity. The Company accounts for these arrangements in accordance with Accounting Standards Codification (ASC) 815, “Accounting for Derivative Instruments and Hedging Activities”. In accordance with accounting principles generally accepted in the United States (U.S. GAAP), derivative instruments and hybrid instruments are recognized as either assets or liabilities on the balance sheet and are measured at fair value with gains or losses recognized in earnings or other comprehensive income depending on the nature of the derivative or hybrid instruments. The Company determines the fair value of derivative instruments and hybrid instruments based on available market data using appropriate valuation models, giving consideration to all of the rights and obligations of each instrument. The derivative liabilities are remeasured at fair value at the end of each reporting period as long as they are outstanding.

Grant Income

The Company's grant arrangements are handled on a reimbursement basis. Grant income under the arrangements is recognized when costs are incurred.

Research and Development Grant Revenues

Research and development expenditures are expensed as incurred.

Net Loss Per Common Share

The Company calculates net loss per common share in accordance with ASC 260 “Earnings Per Share” (ASC 260). Basic and diluted net loss per common share was determined by dividing net loss applicable to common shareholders by the weighted average number of common shares outstanding during the period. The Company’s potentially dilutive shares, which include outstanding common stock options, restricted stock units, convertible preferred stock and common stock warrants, have not been included in the computation of diluted net loss per share for all periods as the result would be anti-dilutive.

Concentration of Credit Risk

Financial instruments, which potentially subject the Company to concentrations of credit risk, consist of cash and cash equivalents.  The Company maintains its cash and cash equivalents with high quality financial institutions.  At times, these accounts may exceed federally insured limits.  The Company has not experienced any losses in such bank accounts.  The Company believes it is not exposed to significant credit risk related to cash and cash equivalents. All non-interest bearing cash balances were fully insured up to $250,000 at September 30, 2016.

Income Taxes

The Company uses the asset and liability method of accounting for income taxes. Under the asset and liability method, deferred tax assets and liabilities are recognized for future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating and tax loss carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The Company records a valuation allowance to reduce the deferred tax assets to the amount that is more likely than not to be recognized. A full valuation allowance was recorded against the deferred tax assets as of September 30, 2016 and 2015.

Use of Estimates

The preparation of financial statements in conformity U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the accompanying disclosures. These estimates are based on management’s best knowledge of current events and actions the Company may undertake in the future. Estimates are used in accounting for, among other items, inventory obsolescence, accruals, stock options, useful lives for depreciation and amortization of long-lived assets, deferred tax assets and the related valuation allowance, and the valuation of derivative liabilities.Actual results could differ from estimates, although management does not generally believe such differences would materially affect the financial statements in any given year. However, in regard to the valuation of derivative liabilities determined using various valuation techniques including the Black-Scholes and binomial pricing methodologies, significant fluctuations may materially affect the financial statements in a given year. The Company considers such valuations to be significant estimates.

Fair Value Measurements

The Company evaluates financial assets and liabilities subject to fair value measurements in accordance with a fair value hierarchy to prioritize the inputs used to measure fair value. A financial instrument’s level within the fair value hierarchy is based on the lowest level of input significant to the fair value measurement, where Level 1 is the highest and Level 3 is the lowest. See Note 12 for the definition of levels and the classification of assets and liabilities in those levels.

Stock-Based Compensation

Compensation cost for all stock-based awards is measured at fair value as of the grant date in accordance with the provisions of ASC 718, “Compensation – Stock Compensation.” The fair value of stock options is calculated using the Black-Scholes option pricing model. The Black-Scholes model requires various judgmental assumptions including volatility and expected option life. The stock-based compensation cost is recognized on the straight line allocation method as expense over the requisite service or vesting period.

Equity instruments issued to non-employees are accounted for in accordance with ASC 505-50, “Equity-Based Payments to Non-Employees.” Accordingly, compensation is recognized when goods or services are received and may be measured using the Black-Scholes valuation model, based on the type of award. The Black-Scholes model requires various judgmental assumptions regarding the fair value of the equity instruments at the measurement date and the expected life of the options.

The Company has Incentive Stock Option Plans, Non-Qualified Stock Options Plans, a Stock Compensation Plan, Stock Bonus Plans and an Incentive Stock Bonus Plan. In some cases, these Plans are collectively referred to as the “Plans.” All Plans have been approved by the Company’s stockholders.

The Company’s stock options are not transferable, and the actual value of the stock options that an employee may realize, if any, will depend on the excess of the market price on the date of exercise over the exercise price. The Company has based its assumption for stock price volatility on the variance of daily closing prices of the Company’s stock. The risk-free interest rate assumption was based on the U.S. Treasury rate at date of the grant with term equal to the expected life of the option. Historical data was used to estimate option exercise and employee termination within the valuation model. The expected term of options represents the period of time that options granted are expected to be outstanding and has been determined based on an analysis of historical exercise behavior. If any of the assumptions used in the Black-Scholes model change significantly, stock-based compensation expense for new awards may differ materially in the future from that recorded in the current period.

Vesting of restricted stock granted under the Incentive Stock Bonus Plan is subject to service, performance or market conditions and meets the classification of equity awards. These awards were measured at fair market value on the grant-dates for issuances where the attainment of performance criteria is probable and at fair value on the grant-dates, using a Monte Carlo simulation for issuances where the attainment of performance criteria is uncertain. The total compensation cost will be expensed over the estimated requisite service period.

Recent Accounting Pronouncements

In May 2014, the FASB issued Accounting Standards Update (ASU) 2014-09, Revenue from Contracts with Customers (Topic 606) that will supersede virtually all recognition guidance in US GAAP. For public entities, the guidance is effective for annual and interim periods beginning after December 15, 2017. Early adoption is permitted for all entities for annual and interim periods beginning after December 15, 2016. The FASB issued the following ASUs to amend the new guidance: ASU 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date, ASU 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net), ASU 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing, and ASU 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients. Management does not expect the new standard or any of the related updates to have a material effect on its financial statements and related disclosures.

In January 2016, the FASB issued Accounting Standards Update (ASU) No. 2016-01, Financial Instruments – Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities. The new guidance is intended to improve the recognition and measurement of financial instruments. The new guidance is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. Early adoption is permitted for specific provisions within the guidance. Management does not expect the new standard to have a material effect on its financial statements and related disclosures.

In February 2016, the FASB issued ASU 2016-02, Leases, which will require most leases (with the exception of leases with terms of less than one year) to be recognized on the balance sheet as an asset and a lease liability. Leases will be classified as an operating lease or a financing lease. Operating leases are expensed using the straight-line method whereas financing leases will be treated similarly to a capital lease under the current standard. The new standard will be effective for annual and interim periods, within those fiscal years, beginning after December 15, 2018, but early adoption is permitted. The new standard must be presented using the modified retrospective method beginning with the earliest comparative period presented. The Company is currently evaluating the effect of the new standard on its financial statements and related disclosures. 

In March 2016, the FASB issued ASU No. 2016-09, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. ASU 2016-09 simplifies several aspects of the accounting for share-based payment award transactions, including income tax consequences, classification of awards as either equity or liabilities and classification on the statement of cash flows. The new standard will be effective for annual and interim periods, within those fiscal years, beginning after December 15, 2016 but early adoption is permitted. The Company is currently evaluating the effect of the new amendment on its financial statements and related disclosures.

In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments. ASU 2016-15 amends eight specific cash flow issues: 1.) Debt Prepayment or Debt Extinguishment Costs, 2.) Settlement of Zero-Coupon Debt Instruments or Other Debt Instruments with Coupon Interest Rates That Are Insignificant in Relation to the Effective Interest Rate of the Borrowing, 3.) Contingent Consideration Payments Made after a Business Combination, 4.) Proceeds from the Settlement of Insurance Claims, 5.) Proceeds from the Settlement of Corporate-Owned Life Insurance Policies, including Bank-Owned Life Insurance Policies, 6.) Distributions Received from Equity Method Investees, 7.) Beneficial Interests in Securitization Transactions, 8.) Separately Identifiable Cash Flows and Application of the Predominance Principle. Management does not expect the adoption of the amendments in this Update to have a material effect on its financial statements and related disclosures.

In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash. ASU 2016-18 requires that a statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Therefore, amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The amendments in this Update are effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. Management does not expect the adoption of the amendments in this Update to have a material effect on its financial statements and related disclosures.

The Company has considered all other recently issued accounting pronouncements and does not believe the adoption of such pronouncements will have a material impact on its financial statements.

Reclassification

Certain prior year items have been reclassified to conform to the current year presentation.

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4. DERIVATIVES LIABILITIES, WARRANTS AND OTHER OPTIONS (Tables)

12 Months Ended

Sep. 30, 2016

Derivative Instruments and Hedging Activities Disclosure [Abstract]

Derivative liabilities, warrants and other options outstanding

Warrant	Issue Date	Shares Issuable upon Exercise of Warrant		Exercise Price		Expiration Date	Refer-ence
Series R	12/6/12		2,625,000	$	4.00	12/6/16		1
Series S	10/11/13 -10/24/14		25,928,010	$	1.25	10/11/18		1
Series U	4/17/14		445,514	$	1.75	10/17/17		1
Series V	5/28/15		20,253,164	$	0.79	5/28/20		1
Series W	10/28/15		17,223,248	$	0.67	10/28/20		1
Series X	1/13/16		3,000,000	$	0.37	1/13/21		2
Series Y	2/15/16		650,000	$	0.48	2/15/21		2
Series Z	5/23/16		6,600,000	$	0.55	11/23/21		1
Series ZZ	5/23/16		500,000	$	0.55	5/18/21		1
Series AA	8/26/16		5,000,000	$	0.55	2/22/22		1
Series BB	8/26/16		400,000	$	0.55	8/22/21		1
Series N	8/18/08		2,844,627	$	0.53	8/18/17		2
Series P	2/10/12		590,001	$	4.50	3/6/17		2
Consultants	12/2/11- 7/1/16		640,000	$	0.37- $3.50	10/27/16- 6/30/19		3

Warrants	Issue Date	Shares Issuable upon Exercise of Warrants		Exercise Price		Expiration Date	Refer-ence
Series N	8/18/08		2,844,627		0.53	8/18/17		1
Series Q	6/21/12		1,200,000		5.00	12/22/15		1
Series R	12/6/12		2,625,000		4.00	12/6/16		1
Series S	10/11/13- 10/24/14		25,928,010		1.25	10/11/18		1
Series U	4/17/14		445,514		1.75	10/17/17		1
Series V	5/28/15		20,253,164		0.79	5/28/20		1
Series P	2/10/12		590,001		4.50	3/6/17		2
Consultants	10/14/05 – 7/1/15		238,000		0.66 – 20.00	10/14/15 - 6/30/18		3

Derivative Liabilities

	2016		2015
Series S warrants	$	3,111,361	$	7,363,555
Series U warrants		-		44,551
Series V warrants		1,620,253		6,278,481
Series W warrants		1,799,858		-
Series Z warrants		970,604		-
Series ZZ warrants		70,609		-
Series AA warrants		763,661		-
Series BB warrants		58,588		-
Total derivative liabilities	$	8,394,934	$	13,686,587

Warrant Series	2016		2015			2014
Series A - E	$	-	$	6,105		$	1
Series F and G		-		-			12,667
Series H		-		12,000			24,000
Series N		-		-			(1,404,027	)
Series Q		-		12,000			36,000
Series R		-		157,500			131,250
Series S		4,252,193		(1,705,466	)		1,098,787
Series T		-		-			276,122
Series U		44,552		75,738			73,967
Series V		4,658,228		1,724,739			-
Series W		3,260,913		-			-
Series Z		997,226		-			-
Series ZZ		75,229		-			-
Series AA		672,246		-			-
Series BB		53,139		-			-
Net gain	$	14,013,726	$	282,616		$	248,767

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5. RESEARCH AND OFFICE EQUIPMENT (Tables)

12 Months Ended

Sep. 30, 2016

Notes to Financial Statements

Research and office equipment

	2016			2015
Research equipment	$	3,158,633		$	3,268,757
Furniture and equipment		133,499			141,347
Leasehold improvements		131,910			131,910
		3,424,042			3,542,014
Accumulated depreciation and amortization		(3,197,826	)		(3,234,548	)
Net research and office equipment	$	226,216		$	307,466

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6. PATENTS (Tables)

12 Months Ended

Sep. 30, 2016

Patents Tables

Schedule of Patents

	2016			2015
Patents	$	1,528,610		$	1,525,791
Accumulated amortization		(1,272,063.00	)		(1,234,227.00	)
Net Patents	$	256,547		$	291,564

Schedule of total estimated future amortization

Years ending September 30,
2017	$	37,000
2018		36,000
2019		35,000
2020		31,000
2021		28,000
Thereafter		90,000
	$	257,000

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7. INCOME TAXES (Tables)

12 Months Ended

Sep. 30, 2016

Income Tax Disclosure [Abstract]

Net deferred tax asset

	2016			2015
Net operating loss carryforwards	$	64,366,000		$	61,363,000
R&D credit		1,221,000			1,221,000
Stock-based compensation		6,379,000			5,855,000
Fixed assets and intangibles		57,000			41,000
Capitalized R&D		18,508,000			15,082,000
Vacation and other		179,000			114,000
Loan modification		-			57,000
Total deferred tax assets		90,710,000			83,733,000
Valuation allowance		(90,710,000	)		(83,733,000	)
Net deferred tax asset	$	-		$	-

Reconciliation of effective tax rate

	2016			2015			2014
Federal Rate		34.00	%		34.00	%		34.00	%
State tax rate, net of federal benefit		3.92			5.12			5.15
State tax rate change		(22.13	)		(0.15	)		(0.93	)
Other adjustments		(0.03	)		(0.21	)		0.00
Adjustment to deferreds		0.00			0.00			19.13
Permanent differences (1)		45.08			(0.71	)		(0.43	)
Change in valuation allowance		(60.84	)		(38.05	)		(58.78	)
Effective tax rate		0.00	%		0.00	%		0.00	%

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8. STOCK COMPENSATION (Tables)

12 Months Ended

Sep. 30, 2016

Disclosure of Compensation Related Costs, Share-based Payments [Abstract]

Employees and non-employees stock compensation

	Year Ended September 30,
	2016		2015		2014
Employees	$	2,113,433	$	5,105,827	$	3,958,637
Non-employees	$	751,651	$	565,915	$	771,946

Assumptions for Option Pricing

	2016	2015	2014
Expected stock price volatility	75.58 – 80.9%	73.38 – 86.19%	72.81 – 86.87%
Risk-free interest rate	0.71 – 1.56%	0.93 – 2.35%	0.59 – 2.65%
Expected life of options	3.0 – 9.69 Years	3.0 – 9.76 Years	3.0 – 9.76 Years
Expected dividend yield	-	-	-

Stock Option Plans

	Outstanding								Exercisable
					Weighted								Weighted
					Ave								Ave
	Number of		Weighted Average		Remaining Contractual		Aggregate Intrinsic		Number of		Weighted Average		Remaining Contractual		Aggregate Intrinsic
	Shares		Exercise Price		Term (Years)		Value		Shares		Exercise Price		Term (Years)		Value
Outstanding at October 1, 2014		6,831,149	$	2.98		6.55	$	3,600		3,443,884	$	3.40		5.49	$	3,600
Vested										1,153,357	$	2.48
Granted (a)		893,700	$	0.66
Forfeited		116,665	$	1.87
Expired		70,499	$	4.15						70,499	$	4.15
Outstanding at September 30, 2015		7,537,685	$	2.71		5.98	$	50		4,526,742	$	3.15		5.01	$	0
Vested										1,401,716	$	1.27
Granted (b)		1,213,600	$	0.48
Forfeited		55,998	$	0.86
Expired		106,000	$	5.80						106,000	$	5.80
Outstanding at September 30, 2016		8,589,287	$	2.37		5.35	$	0		5,822,458	$	2.65		4.76	$	0

Schedule of non-vested options

				Weighted Average
	Number of			Grant Date
	Options			Fair Value
Unvested at October 1, 2014		3,387,265		$	2.15
Vested		(1,153,357	)
Granted		893,700
Forfeited		(116,665	)
Unvested at September 30, 2015		3,010,943		$	1.72
Vested		(1,401,716	)
Granted		1,213,600
Forfeited		(55,998	)
Unvested at September 30, 2016		2,766,829		$	1.48

Schedule of restricted stock units

	Number of Shares			Weighted Average Grant Date Fair Value
Unvested at October 1, 2014		15,700,000		$	0.55
Vested		(500,000	)
Granted		-
Forfeited		(100,000	)
Unvested at September 30, 2015		15,100,000		$	0.55
Vested		-
Unvested at September 30, 2016		15,100,000		$	0.55

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10. COMMITMENTS AND CONTINGENCIES (Tables)

12 Months Ended

Sep. 30, 2016

Commitments And Contingencies Tables

Schedule of future minimum annual rental payments due under non-cancelable operating leases

Years Ending September 30,
2017	$	1,930,000
2018		1,997,000
2019		2,066,000
2020		2,110,000
2021		2,100,000
Thereafter		15,831,000
Total minimum lease payments:	$	26,034,000

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13. FAIR VALUE MEASUREMENTS (Tables)

12 Months Ended

Sep. 30, 2016

Fair Value Measurements Tables

Measured at fair value on a recurring basis

The table below sets forth the liabilities measured at fair value on a recurring basis, by input level, on the balance sheet at September 30, 2016:

	Quoted Prices in	Significant
	Active Markets for	Other	Significant
	Identical Assets or	Observable	Unobservable
	Liabilities (Level 1)	Inputs (Level 2)	Inputs (Level 3)	Total
Derivative Instruments	$3,111,361	-	$5,283,573	$8,394,934

The table below sets forth the liabilities measured at fair value on a recurring basis, by input level, on the balance sheet at September 30, 2015:

	Quoted Prices in	Significant
	Active Markets for	Other	Significant
	Identical Assets or	Observable	Unobservable
	Liabilities (Level 1)	Inputs (Level 2)	Inputs (Level 3)	Total
Derivative Instruments	$7,365,555	-	$6,323,032	$13,686,587

Reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3)

	2016			2015
Beginning balance	$	6,323,032		$	307,894
Issuances		8,722,073			8,003,220
Net realized and unrealized derivative gain		(9,761,532	)		(1,988,082	)
Ending balance	$	5,283,573			$6,323,032

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14. NET LOSS PER COMMON SHARE (Tables)

12 Months Ended

Sep. 30, 2016

Net Loss Per Common Share Tables

Earnings per share

	2016			2015			2014
Net loss available to
common shareholders	$	(11,466,498	)	$	(34,674,646	)	$	(28,483,712	)
Less: Gain on derivative
Instruments		-			-			(248,767)
Net loss - diluted	$	(11,466,498	)	$	(34,674,646	)	$	(28,732,479	)
Weighted average number of
shares - basic and diluted		121,655,108			82,519,027			58,804,622
Loss per share - basic	$	(0.09	)	$	(0.42	)	$	(0. 48	)
Loss per share - diluted	$	(0.09	)	$	(0.42	)	$	(0. 49	)

Antidilutive securities

	2016		2015		2014
Options and Warrants		91,882,022		58,421,058		39,994,707
Convertible Debt		-		1,871,283		276,014
Unvested Restricted Stock		15,100,000		15,100,000		15,700,000
Total		106,982,022		75,392,341		55,970,721

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16. QUARTERLY INFORMATION (Tables)

12 Months Ended

Sep. 30, 2016

Quarterly Financial Information Disclosure [Abstract]

QUARTERLY INFORMATION

Fiscal 2016
	Three months		Three months			Three months			Three months
	ended		ended			ended			Ended			Year ended
	December 31 2015		March 31, 2016			June 30, 2016			September 30, 2016			September 30, 2016
Grant income and other	$	20,976	$	32,775		$	129,975		$	101,329		$	285,055
Operating expenses		5,804,108		6,306,378			6,512,722			7,215,072			25,838,280
Non-operating (expense) income, net		1,985		22,478			24,679			23,859			73,001
Gain (loss) on derivative instruments		8,122,960		(2,593,730	)		2,508,744			5,975,752			14,013,726
Net income (loss) available to
common shareholders	$	2,341,813	$	(8,844,855	)	$	(3,849,324	)	$	(1,114,132	)	$	(11,466,498	)
EPS (LPS) -basic and diluted	$	0.02	$	(0.07	)	$	(0.03	)	$	(0.01	)	$	(0.09	)
Weighted average shares:
Basic		109,768,502		118,420,327			124,132,500			134,290,870			121,655,108
Diluted		111,639,785		118,420,327			124,132,500			134,290,870			121,655,108

Fiscal 2015
	Three months			Three months			Three months			Three months
	ended			ended			ended			Ended			Year ended
	December 31 2014			March 31, 2015			June 30, 2015			September 30, 2015			September 30, 2015
Grant income and other	$	136,838		$	197,620		$	389,223		$	(66,304	)	$	657,377
Operating expenses		10,132,579			7,956,963			8,590,698			8,273,682			34,953,922
Non-operating (expense) income, net		(12,547	)		(14,097	)		(35,985	)		22,369			(40,260	)
Gain (loss) on derivative instruments		2,162,970			(4,782,796	)		4,428,780			(1,526,338	)		282,616
Loss on debt extinguishment		-			-			(620,457	)		-			(620,457	)
Net loss available to
common shareholders	$	(7,845,318	)	$	(12,556,236	)	$	(4,429,137	)	$	(9,843,955	)	$	(34,674,646	)
Net loss per share-basic	$	(0.11	)	$	(0.17	)	$	(0.05	)	$	(0.10	)	$	(0.42	)
Net loss per share-diluted	$	(0.14	)	$	(0.17	)	$	(0.06	)	$	(0.10	)	$	(0.42	)
Weighted average shares:
Basic		73,260,783			75,847,869			83,796,311			97,040,004			82,519,027
Diluted		73,260,783			75,847,869			85,134,107			97,040,004			82,519,027

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3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details)	Sep. 30, 2016 USD ($)
Summary Of Significant Accounting Policies Details
Fully Insured Amount of non-interest bearing cash balances	$ 250,000

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4. DERIVATIVES LIABILITIES, WARRANTS AND OTHER OPTIONS Outstanding (Details) - $ / shares	12 Months Ended
	Sep. 30, 2016	Sep. 30, 2015
Series N [Member]
STOCKHOLDERS' EQUITY
Issue Date	Aug. 18, 2008	Aug. 18, 2008
Shares Issuable upon Exercise of Warrant	2,844,627	2,844,627
Exercise Price	$ 0.53	$ 0.53
Expiration Date	Aug. 18, 2017	Aug. 18, 2017
Series Q [Member]
STOCKHOLDERS' EQUITY
Issue Date		Jun. 21, 2012
Shares Issuable upon Exercise of Warrant		1,200,000
Exercise Price		$ 5
Expiration Date		Dec. 22, 2015
SeriesRMember
STOCKHOLDERS' EQUITY
Issue Date	Dec. 06, 2012	Dec. 06, 2012
Shares Issuable upon Exercise of Warrant	2,625,000	2,625,000
Exercise Price	$ 4	$ 4
Expiration Date	Dec. 06, 2016	Dec. 06, 2016
Series S [Member]
STOCKHOLDERS' EQUITY
Shares Issuable upon Exercise of Warrant	25,928,010	25,928,010
Exercise Price	$ 1.25	$ 1.25
Expiration Date	Oct. 11, 2018	Oct. 11, 2018
Issue Start date	Oct. 11, 2013	Oct. 11, 2013
Issue End Date	Oct. 24, 2014	Oct. 24, 2014
Series U [Member]
STOCKHOLDERS' EQUITY
Issue Date	Apr. 17, 2014	Apr. 17, 2014
Shares Issuable upon Exercise of Warrant	445,514	445,514
Exercise Price	$ 1.75	$ 1.75
Expiration Date	Oct. 17, 2017	Oct. 17, 2017
Series V [Member]
STOCKHOLDERS' EQUITY
Issue Date	May 28, 2015	May 28, 2015
Shares Issuable upon Exercise of Warrant	20,253,164	20,253,164
Exercise Price	$ 0.79	$ 0.79
Expiration Date	May 28, 2020	May 28, 2020
Series P [Member]
STOCKHOLDERS' EQUITY
Issue Date	Feb. 10, 2012	Feb. 10, 2012
Shares Issuable upon Exercise of Warrant	590,001	590,001
Exercise Price	$ 4.5	$ 4.5
Expiration Date	Mar. 06, 2017	Mar. 06, 2017
Consultants [Member]
STOCKHOLDERS' EQUITY
Shares Issuable upon Exercise of Warrant	640,000	238,000
Issue Start date	Dec. 02, 2011	Oct. 14, 2005
Issue End Date	Jul. 01, 2016	Jul. 01, 2015
Expiration start date	Oct. 27, 2016	Oct. 14, 2015
Expiration end date	Jun. 30, 2019	Jun. 30, 2018
Exercise Price Minimum	$ .37	$ .66
Exercise Price Maximum	$ 3.50	$ 20.00
Series W [Member]
STOCKHOLDERS' EQUITY
Issue Date	Oct. 28, 2015
Shares Issuable upon Exercise of Warrant	17,223,248
Exercise Price	$ 0.67
Expiration Date	Oct. 28, 2020
Series X [Member]
STOCKHOLDERS' EQUITY
Issue Date	Jan. 13, 2016
Shares Issuable upon Exercise of Warrant	3,000,000
Exercise Price	$ 0.37
Expiration Date	Jan. 13, 2021
Series Y [Member]
STOCKHOLDERS' EQUITY
Issue Date	Feb. 15, 2016
Shares Issuable upon Exercise of Warrant	650,000
Exercise Price	$ 0.48
Expiration Date	Feb. 15, 2021
Series Z [Member]
STOCKHOLDERS' EQUITY
Issue Date	May 23, 2016
Shares Issuable upon Exercise of Warrant	6,600,000
Exercise Price	$ 0.55
Expiration Date	Nov. 23, 2021
Series ZZ [Member]
STOCKHOLDERS' EQUITY
Issue Date	May 23, 2016
Shares Issuable upon Exercise of Warrant	500,000
Exercise Price	$ 0.55
Expiration Date	May 18, 2021
Series AA [Member]
STOCKHOLDERS' EQUITY
Issue Date	Aug. 26, 2016
Shares Issuable upon Exercise of Warrant	5,000,000
Exercise Price	$ 0.55
Expiration Date	Feb. 22, 2022
Series BB [Member]
STOCKHOLDERS' EQUITY
Issue Date	Aug. 26, 2016
Shares Issuable upon Exercise of Warrant	400,000
Exercise Price	$ 0.55
Expiration Date	Aug. 22, 2021

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4. DERIVATIVES LIABILITIES, WARRANTS AND OTHER OPTIONS (Details 2) - USD ($)	3 Months Ended								12 Months Ended
	Sep. 30, 2016	Jun. 30, 2016	Mar. 31, 2016	Dec. 31, 2015	Sep. 30, 2015	Jun. 30, 2015	Mar. 31, 2015	Dec. 31, 2014	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2014
Derivative Gain on Derivative	$ 5,975,752	$ 2,508,744	$ (2,593,730)	$ 8,122,960	$ (1,526,338)	$ 4,428,780	$ (4,782,796)	$ 2,162,970	$ 14,013,726	$ 282,616	$ 248,767
Series A through E warrants
Derivative Gain on Derivative									0	6,105	1
Series N [Member]
Derivative Gain on Derivative									0	0	(1,404,027)
SeriesFAndGWarrantsMember
Derivative Gain on Derivative									0	0	12,667
Series H [Member]
Derivative Gain on Derivative									0	12,000	24,000
Series T [Member]
Derivative Gain on Derivative									0	0	276,122
Series Q [Member]
Derivative Gain on Derivative									0	12,000	36,000
SeriesRMember
Derivative Gain on Derivative									0	157,500	131,250
Series S [Member]
Derivative Gain on Derivative									4,252,193	(1,705,466)	1,098,787
Series U [Member]
Derivative Gain on Derivative									44,552	75,738	73,967
Series V [Member]
Derivative Gain on Derivative									4,658,228	1,724,739	0
Series V [Member]
Derivative Gain on Derivative									3,260,913	0	0
Series Z [Member]
Derivative Gain on Derivative									997,226	0	0
Series ZZ [Member]
Derivative Gain on Derivative									75,229	0	0
Series AA [Member]
Derivative Gain on Derivative									672,246	0	0
Series BB [Member]
Derivative Gain on Derivative									$ 53,139	$ 0	$ 0

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4. DERIVATIVES LIABILITIES, WARRANTS AND OTHER OPTIONS (Details Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2014
Derivatives Liabilities Warrants And Other Options Details Narrative
Gain on warrants	$ 14,013,726	$ 282,616	$ 248,767

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5. RESEARCH AND OFFICE EQUIPMENT (Details) - USD ($)	Sep. 30, 2016	Sep. 30, 2015
Research And Office Equipment Details
Research equipment	$ 3,158,633	$ 3,268,757
Furniture and equipment	133,499	141,347
Leasehold improvements	131,910	131,910
Gross	3,424,042	3,542,014
Less: Accumulated depreciation and amortization	(3,197,826)	(3,234,548)
Net research and office equipment	$ 226,216	$ 307,466

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5. RESEARCH AND OFFICE EQUIPMENT (Details Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2014
Research And Office Equipment Details Narrative
Depreciation expense	$ 112,000	$ 166,279	$ 188,967

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6. PATENTS (Details) - USD ($)	Sep. 30, 2016	Sep. 30, 2015
Finite-Lived Intangible Assets, Net [Abstract]
Patents	$ 1,258,610	$ 1,525,791
Accumulated amortization	(1,272,063)	(1,234,227)
Net Patents	$ 256,547	$ 291,564

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6. PATENTS (Details 1) - USD ($)	Sep. 30, 2016	Sep. 30, 2015
Patents Details 1
2017	$ 37,000
2018	36,000
2019	35,000
2020	31,000
2021	28,000
Thereafter	90,000
Total	$ 256,547	$ 291,564

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6. PATENTS (Details Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2014
Patents Details Narrative
Amortization of patent costs	$ 38,000	$ 40,471	$ 42,785

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7. INCOME TAXES Net deferred tax asset (Details) - USD ($)	Sep. 30, 2016	Sep. 30, 2015
Income Taxes Net Deferred Tax Asset Details
Net operating loss carryforwards	$ 64,366,000	$ 61,363,000
R&D credit	1,221,000	1,221,000
Stock-based compensation	6,379,000	5,855,000
Fixed assets and intangibles	57,000	41,000
Capitalized R&D	18,508,000	15,082,000
Vacation and other	179,000	114,000
Loan modification	0	57,000
Total deferred tax assets	90,710,000	83,733,000
Valuation allowance	(90,710,000)	(83,733,000)
Net deferred tax asset	$ 0	$ 0

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7. INCOME TAXES Reconciliation of effective tax rate (Details)	12 Months Ended
	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2014
Income Taxes Reconciliation Of Effective Tax Rate Details
Federal Rate	34.00%	34.00%	34.00%
State tax rate, net of federal benefit	3.92%	5.12%	5.15%
State tax rate change	(22.13%)	(0.15%)	0.93%
Other adjustments	(0.03%)	(0.21%)	0.00%
Expired tax attributes	0.00%	0.00%	0.00%
Adjustment to Deferreds	0.00%	0.00%	19.13%
Permanent differences	45.08%	(0.71%)	(0.43%)
Change in valuation allowance	(60.84%)	(38.05%)	(58.78%)
Effective tax rate	0.00%	0.00%	0.00%

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8. STOCK COMPENSATION Awards (Details) - USD ($)	12 Months Ended
	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2014
Stock Compensation Awards Details
Employees	$ 2,113,433	$ 5,105,827	$ 3,958,637
Non-employees	$ 751,651	$ 565,915	$ 771,946

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8. STOCK COMPENSATION Assumptions (Details)	12 Months Ended
	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2014
Stock Compensation Assumptions Details
Expected stock price volatility, min	75.58%	73.38%	72.81%
Expected stock price volatility, max	80.90%	86.19%	86.87%
Risk-free interest rate, min	0.71%	0.93%	0.59%
Risk-free interest rate, max	1.056%	2.35%	2.65%
Expected life of options, min	3 years	3 years	3 years
Expected life of options, max	9 years 8 months 8 days	9 years 9 months 4 days	9 years 9 months 4 days
Expected dividend yield	0.00%	0.00%	0.00%

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8. STOCK COMPENSATION Non-Qualified and Incentive Stock Option Plans (Details) - USD ($)	12 Months Ended
	Sep. 30, 2016	Sep. 30, 2015
Outstanding
Number of Options Outstanding, Beginning	7,537,685	6,831,149
Number of Options Granted	1,213,600	893,700
Number of Options Forfeited	55,998	116,665
Number of Options Expired	106,000	70,499
Number of Options Outstanding, Ending	8,589,287	7,537,685
Weighted Average Exercise Price Outstanding, Beginning	$ 2.71	$ 2.98
Weighted Average Exercise Price Granted	0.48	0.66
Weighted Average Exercise Price Forfeited	0.86	1.87
Weighted Average Exercise Price Expired	5.8	4.15
Weighted Average Exercise Price Outstanding, Ending	$ 2.37	$ 2.71
Weighted Average Remaining Contractual Life (in years) Outstanding, Beginning	5 years 11 months 23 days	6 years 6 months 18 days
Weighted Average Remaining Contractual Life (in years) Outstanding, Ending	5 years 4 months 6 days	5 years 11 months 23 days
Aggregate Intrinsic Value Outstanding, Beginning	$ 50	$ 3,600
Aggregate Intrinsic Value Outstanding, Ending	$ 0	$ 50
Exercisable
Number of Options Outstanding, Beginning	4,526,742	3,443,884
Number of Options Vested	1,401,716	1,153,357
Number of Options Expired	106,000	70,499
Number of Options Outstanding, Ending	5,822,458	4,526,742
Weighted Average Exercise Price Outstanding, Beginning	$ 3.15	$ 3.4
Weighted Average Exercise Price Vested	1.27	2.48
Weighted Average Exercise Price Expired	5.8	4.15
Weighted Average Exercise Price Outstanding, Ending	$ 2.65	$ 3.15
Weighted Average Remaining Contractual Life (in years) Outstanding, Beginning	5 years 4 days	5 years 5 months 26 days
Weighted Average Remaining Contractual Life (in years) Outstanding, Ending	4 years 9 months 4 days	5 years 4 days
Aggregate Intrinsic Value Outstanding, Beginning	$ 0	$ 3,600
Aggregate Intrinsic Value Outstanding, Ending	$ 0	$ 0

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8. STOCK COMPENSATION Nonvested Options (Details) - $ / shares	12 Months Ended
	Sep. 30, 2016	Sep. 30, 2015
Stock Compensation Nonvested Options Details
Number of unvested options, Beginning	3,010,943	3,387,265
Vested options	(1,401,716)	(1,153,357)
Granted options	1,213,600	893,700
Forfeited options	(55,998)	(116,665)
Number of unvested options, Ending	2,766,829	3,010,943
Weighted Average Grant Date Fair Value, Beginning	$ 1.72	$ 2.15
Weighted Average Grant Date Fair Value, Ending	$ 1.48	$ 1.72

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8. STOCK COMPENSATION RSU (Details) - $ / shares	12 Months Ended
	Sep. 30, 2016	Sep. 30, 2015
Weighted Average Grant Date Fair Value, Ending	$ 1.48	$ 1.72
Restricted Stock Awards [Member]
Number of unvested shares, Beginning	15,100,000	15,700,000
Vested shares	(500,000)	(500,000)
Granted shares	0	0
Forfeited shares	(100,000)	(100,000)
Number of unvested shares, Ending	15,100,000	15,100,000
Weighted Average Grant Date Fair Value, Ending	$ 0.55	$ 0.55

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8. STOCK COMPENSATION (Details Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2016	Sep. 30, 2015
Stock Compensation Details Narrative
Expense relating to the restricted stock	$ 634,000	$ 3,400,000
Unrecognized compensation expense	$ 3,100,000
Weighted average period	5 years 11 days

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9. EMPLOYEE BENEFIT PLAN (Detail Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2014
Employee Benefits and Share-based Compensation [Abstract]
Expense for Company's contribution to employee benefit plan	$ 168,000	$ 170,000	$ 160,000

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10. COMMITMENTS AND CONTINGENCIES (Details)	Sep. 30, 2016 USD ($)
Commitments And Contingencies Details
2017	$ 1,930,000
2018	1,997,000
2019	2,066,000
2020	2,110,000
2021	2,100,000
Thereafter	15,831,000
Total minimum lease payments:	$ 26,034,000

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10. COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)	12 Months Ended
	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2014
Research and development expense	$ 19,351,779	$ 21,098,147	$ 17,172,587
Rent expense, including amortization of deferred rent	2,700,000	2,700,000	2,700,000
Total deferred rent asset	3,800,000	4,500,000
Deferred rent asset, non-current	3,406,921	4,044,473
R & D deferred rent liability	2,000	6,000
Deferred rent liability	18,000	13,000
Ergomed Collaborative Arrangement
Research and development expense	$ 7,200,000	$ 6,700,000	$ 4,400,000

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13. FAIR VALUE MEASUREMENTS (Details) - USD ($)	Sep. 30, 2016	Sep. 30, 2015
Level1
Derivative instruments	$ 3,111,361	$ 7,363,555
Level2
Derivative instruments	0	0
Level3
Derivative instruments	5,283,573	6,323,032
Total
Derivative instruments	$ 8,394,934	$ 13,686,587

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13. FAIR VALUE MEASUREMENTS (Details 1) - USD ($)	12 Months Ended
	Sep. 30, 2016	Sep. 30, 2015
Fair Value Measurements Details 1
Beginning balance	$ 6,323,032	$ 307,894
Issuances	8,722,073	8,003,220
Net realized and unrealized derivative (gain)/loss	(9,761,532)	(1,988,082)
Ending balance	$ 5,283,573	$ 6,323,032

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14. NET LOSS PER COMMON SHARE (Details) - USD ($)	3 Months Ended								12 Months Ended
	Sep. 30, 2016	Jun. 30, 2016	Mar. 31, 2016	Dec. 31, 2015	Sep. 30, 2015	Jun. 30, 2015	Mar. 31, 2015	Dec. 31, 2014	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2014
Net Loss Per Common Share Details
Net loss - available to common shareholders	$ (1,114,132)	$ (3,849,324)	$ (8,844,855)	$ 2,341,813	$ (9,843,955)	$ (4,429,137)	$ (12,556,236)	$ (7,845,318)	$ (11,466,498)	$ (34,674,646)	$ (28,483,712)
Less: Gain on derivative Instruments									0	0	(248,767)
Net loss - diluted									$ (11,466,498)	$ (34,674,646)	$ (28,732,479)
Weighted average number of shares - basic and diluted									121,655,108	82,519,027	58,804,622
Loss per share - basic					$ (0.10)	$ (0.05)	$ (0.17)	$ (0.11)	$ (0.09)	$ (0.42)	$ (0.48)
Loss per share - diluted					$ (0.10)	$ (0.06)	$ (0.17)	$ (0.14)	(0.09)	$ (0.42)	$ (0.49)
EPS (LPS) - Basic and Diluted	$ (0.01)	$ (0.03)	$ (0.07)	$ 0.02					$ (0.09)

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14. NET LOSS PER COMMON SHARE (Details 1) - shares	12 Months Ended
	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2014
Net Loss Per Common Share Details 1
Options and warrants excluded from earnings per share due to anti-dilutive effect	91,882,022	58,421,058	39,994,707
Convertible Debt	0	1,871,283	276,014
Unvested Restricted Stock	15,100,000	15,100,000	15,700,000
Total	106,982,022	75,392,341	55,970,721

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16. QUARTERLY INFORMATION (Details) - USD ($)	3 Months Ended								12 Months Ended
	Sep. 30, 2016	Jun. 30, 2016	Mar. 31, 2016	Dec. 31, 2015	Sep. 30, 2015	Jun. 30, 2015	Mar. 31, 2015	Dec. 31, 2014	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2014
Quarterly Information Details
Grant income and other	$ 101,329	$ 129,975	$ 32,775	$ 20,976	$ (66,304)	$ 389,223	$ 197,620	$ 136,838	$ 285,055	$ 657,377	$ 264,033
Operating expenses	7,215,072	6,512,722	6,306,378	5,804,108	8,273,682	8,590,698	7,956,963	10,132,579	25,838,280	34,953,922	27,838,145
Non-operating (expense) income, net	23,859	24,679	22,478	1,985	22,369	(15,166)	(14,097)	(12,547)	73,001	(19,441)
Gain (loss) on derivative instruments	5,975,752	2,508,744	(2,593,730)	8,122,960	(1,526,338)	4,428,780	(4,782,796)	2,162,970	14,013,726	282,616	248,767
Loss on debt extinguishment					0	(620,457)	0	0	0	(620,457)	0
Net loss									(11,466,498)	(34,674,646)	(27,366,265)
Net loss available to common shareholders	$ (1,114,132)	$ (3,849,324)	$ (8,844,855)	$ 2,341,813	$ (9,843,955)	$ (4,429,137)	$ (12,556,236)	$ (7,845,318)	$ (11,466,498)	$ (34,674,646)	$ (28,483,712)
Net income (loss) per share-basic and diluted	$ (0.01)	$ (0.03)	$ (0.07)	$ 0.02					$ (0.09)
Net loss per share-basic					$ (0.10)	$ (0.05)	$ (0.17)	$ (0.11)	(0.09)	$ (0.42)	$ (0.48)
Net loss per share-diluted					$ (0.10)	$ (0.06)	$ (0.17)	$ (0.14)	$ (0.09)	$ (0.42)	$ (0.49)
Weighted average shares-basic and diluted									121,655,108	82,519,027	58,804,622
Weighted average shares-basic	134,290,870	124,132,500	118,420,327	109,768,502	97,040,004	83,796,311	75,847,869	73,260,783	121,655,108	82,519,027
Weighted average shares-diluted	134,290,870	124,132,500	118,420,327	111,639,785	97,040,004	85,134,107	75,847,869	73,260,783	121,655,108	82,519,027