UNITED STATES

SECURITIES AND EXCHANGE COMMISSION 

Washington, D.C. 20549

 

Form 8-K

 

Current Report Pursuant to Section 13 or 15(d) of 

The Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): October 20, 2014

 

CELLCEUTIX CORPORATION

(Exact name of registrant as specified in its charter)

  

Nevada

 

000-52321

 

30-0565645

(State or other jurisdiction of incorporation)

 

(Commission File Number)

 

(I.R.S. Employer Identification No.)

  

100 Cumming Center, Suite 151-B
Beverly, MA 01915
(Address of principal executive offices and zip code)

 

Registrant’s telephone number, including area code: (978) 236-8717

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

 

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

On October 20, 2014 the Board of Directors approved the appointment of Dr. William James Alexander as the Chief Operations Officer of Cellceutix Corporation for the term of one year effective October 27th, 2014. Dr. Alexander had been serving Cellceutix as a medical consultant since 2012. From June 2006 to June 2008 he served as Vice President, Clinical Development at BioCryst Pharmaceuticals. From July 2008 to present he operated as a sole proprietorship under the name of Alexander Pharma Consulting, LLC.

 

Dr. Alexander previously held clinical development and/or pharmacovigilance positions with SmithKline Beecham, Glaxo, Glaxo Wellcome, and BioCryst. He has contributed to clinical development programs supporting the approval of drugs for the treatment of bacterial and viral infections (HIV, herpes viruses, and influenza), asthma, COPD, and migraine. Dr. Alexander received his M.D. from the University of Mississippi and his M.P.H. from the University of Alabama at Birmingham. He is board certified in internal medicine and infectious diseases. From March 29, 2014 to October 24, 2014 he served as Senior Director, Medical Affairs, Chiesi, USA.

 

Pursuant to his employment agreement, Dr. Alexander received a stock grant of 50,000 shares and 50,000 stock options vesting during the next 12 months. The Company is not aware of any transaction requiring disclosure under Item 404(a) of Regulation S-K.

 

ITEM 7.01. REGULATION FD DISCLOSURE.

 

In a Press Release Cellceutix Announced Positive Top-Line Data From Phase 2b ABSSSI Trial; Single-Dose Brilacidin Comparable to 7-Days of Daptomycin

 

The trial, which began in February, enrolled 215 subjects, with approximately 25% in each treatment arm. The primary endpoint was clinical success in the intent-to-treat population, defined as reduction of at least 20% in area of ABSSSI lesion, relative to baseline, when observed 48-72 hours after the first dose of study drug, and no rescue antibiotics administered. This is consistent with the 2013 Food and Drug Administration (FDA) guidance for ABSSSI studies and is the same endpoint used in recent approvals for ABSSSI drugs. All three Brilacidin treatment arms (two single-dose regimens and one three-day dose regimen) reached the primary endpoint, with the clinical success rate for each dosing regimen statistically comparable to the clinical success rate of the FDA-approved seven-day dosing regimen of daptomycin. All Brilacidin treatment regimens were well tolerated. There were six severe adverse events (SAE) reported across the study, none of which were considered related to Brilacidin by the principal investigator.

 

The information in this Item 7.01 of this Form 8-K is being furnished and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that section. The information in this Item 7.01 of this Form 8-K also shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, except to the extent that the Company specifically incorporates it by reference.

   

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits

 

The following exhibit is filed as part of this report:

 

Exhibit

   

Number

 

Description

10-1

 

Employment Agreement Dr. William James Alexander,

99-1

Press release: Cellceutix Announces Positive Top-Line Data From Phase 2b ABSSSI Trial; Single-Dose Brilacidin Comparable to 7-Days of Daptomycin

  

 
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SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

CELLCEUTIX CORPORATION

 
       

Date: October 23, 2014

By:

/s/ Leo Ehrlich

 
   

Leo Ehrlich

 
   

Chief Executive Officer

 

 

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EXHIBIT 10.1

EMPLOYMENT AGREEMENT 

THIS EMPLOYMENT AGREEMENT (this “Agreement”) is made and entered into effective as of the 27th day of October, 2014 (the “Effective Date”), by and between Cellceutix Corporation, a Nevada corporation (the “Company”), and Dr. William James Alexander, an individual (the “Executive”).

 

RECITALS

 

WHEREAS, the Company is a clinical stage biotechnology company focused on discovering small molecule drugs for hard to treat diseases, including drug-resistant cancers, psoriasis, autism and inflammatory disease; and

 

WHEREAS, the Company desires to employ the Executive, and the Executive desires to be employed by the Company, in the capacity as its Chief Operating Officer (“COO”) and

 

WHEREAS, the Company and the Executive have negotiated with respect to the terms of employment as contemplated herein.

 

NOW, THEREFORE, in consideration of the mutual covenants and representations contained herein, and the mutual benefits derived herefrom, the parties hereto, intending to be legally bound, agree as follows:

  

 
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AGREEMENT 

ARTICLE I 

EMPLOYMENT OF EXECUTIVE

 

1.1 DUTIES AND STATUS; REIMBURSEMENTS.

 

(a) The Company hereby engages the Executive as Chief Operating Officer (COO) (an officer of the Company) for the period specified in Section 3.1 below (the “Employment Period”), and the Executive accepts such employment, on the terms and conditions set forth in this Agreement.

 

(b) The Executive shall serve (i) in a management capacity as COO and shall perform such duties and responsibilities appropriate to, and consistent with that position, but at all times shall act in accordance with the directions given by the Chief Executive Officer (“CEO”) of the Company and accordingly, and not by way of limitation, as COO, the Executive shall be responsible for the active day-to-day operations of the Company and (ii) in a strategic and developmental capacity and shall perform such duties and responsibilities to, and consistent with that position, but at all times shall act in accordance with the directions given by the CEO of the Company. As COO, the Executive shall be responsible for oversight of the conduct of the Company’s clinical development programs in accordance with Good Clinical Practice and all regulatory obligations. In addition, as COO the Executive will support and promote development and implementation of programs including collaboration with strategic business partners.

 

(c) Throughout the Employment Period, the Executive shall devote substantially all of his full time business efforts to the business of the Company and shall not engage in consulting work or any trade or business for his own account or for or on behalf of any other person, firm or entity which competes, conflicts or interferes with the performance of his duties under this Agreement in any way; provided, however, nothing contained herein will prevent the Executive from serving on the board of directors of any company that does not compete with the Company, or from serving on the board of directors of any charitable or philanthropic organization, or from serving ‘pro bono’ as chair or member of a Data Safety Monitoring board for NIH clinical development projects, the focus of which do not compete with interests of the Company.

 

(d) During the Employment Period, Employee shall perform and discharge faithfully, diligently, in good faith and to the best of Employee’s ability the duties and responsibilities pursuant to Section 1(b).

 

(e) Executive shall be based in Cary, North Carolina. Following submission by Executive to the Company of reasonable documentation thereof, Executive shall be reimbursed for economy class airfare and hotel for business travel in the continental United States, and for business class airfare and economy class hotel for business travel to Asia and Europe. Executive shall not be entitled to any reimbursements for any home office expenses including, without limitation, telephone, computer, printer, equipment and office or other supplies.

 

1.2 COMPENSATION. The Executive shall be compensated as follows:

 

(a) Commencing on the Effective Date and ending on the six month anniversary of the Effective Date (the “Six Month Anniversary”), the Company shall pay the Executive at the per annum rate of Three Hundred Fifty Thousand Dollars ($350,000.00).

 

(b) Commencing on the Six Month Anniversary and ending on the one year anniversary of the Effective Date (the “One Year Anniversary”), the Company shall pay the Executive at the per annum rate of Four Hundred Thousand Dollars ($400,000.00).

 

Compensation paid pursuant to this Agreement and this Section 1.2 is subject to applicable withholding and payroll taxes and payable in accordance with Company’s normal payroll procedures.

 

 
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1.3 BONUSES. Sign On Bonus- . In connection with the appointment of the Executive as COO, the Executive shall be awarded Effective Immediately 50,000 shares of the Company’s common stock, par value $0.0001 per share (“Common Stock”). OTHER BONUS- The Company shall award the Executive an annual bonus at the sole discretion of the Board of Directors of the Company.

 

1.4 STOCK OPTIONS AWARD. In connection with the appointment of the Executive as COO, the Executive shall be awarded 50,000 stock options (the “Options”) to purchase shares of the Company’s common stock, par value $0.0001 per share (“Common Stock”) at $ 2.93 per share, the last closing price prior to the signing of this agreement. Such options shall vest in equal installments as follows:

 

(a) 50% (25,000 shares) on July 27, 2015

 

(b) 50% (25,000 shares) on October 27, 2015

 

Subject to the forfeiture provisions in Section 3.3 herein, any vested Options will be deemed to be the property of the Executive and must be exercised within three (3) years from the vesting date of such Options.

 

1.5 BENEFITS. During the Employment Period, the Executive shall be entitled to participate in any and all employee benefit plans, programs or arrangements which may be implemented by the Company from time to time and available to similarly-situated employees of the Company. Notwithstanding the foregoing, the Company will provide the Executive and his spouse with health insurance, dental insurance, and a prescription drug plan during the Employment Period.

 

ARTICLE II 

COMPETITION AND CONFIDENTIAL INFORMATION

 

2.1 COMPETITION AND CONFIDENTIAL INFORMATION. The Executive will have access to and will acquire, and may assist in developing confidential and proprietary information relating to the business and operations of the Company and its affiliates, including, but not limited to, information with respect to present and prospective business plans, financing arrangements, marketing plans, customer and supplier lists, contracts and proposals.

 

The Executive acknowledges that such information has been and will continue to be of central importance to the business of the Company and its affiliates and that disclosure or use by others could cause substantial loss to the Company and its affiliates.

 

The Executive accordingly agrees that, during the Employment Period and for a period of one year after the One Year Anniversary, the Executive will not, either individually or as owner, partner, agent, employee, or consultant, engage in any activity competitive with the Company or any of its affiliates and will not on his own behalf, or on behalf of any third party, directly or indirectly hire, discuss employment with, or recommend to any third party the employment of any employee of the Company or any of its affiliates who was actively employed by the Company or an affiliate on the Effective Date without regard to whether that employee has subsequently terminated his or her employment with the Company.

 

The Executive also agrees that, during the Employment Period and for a period of one year after the One Year Anniversary, the Executive will not, either individually or as owner, partner, agent, employee, or consultant of another entity, solicit directly or indirectly business of the nature engaged in by the Company from a current customer of the Company or a former customer of the Company with which the Executive has dealt on behalf of the Company, or on his own behalf or that of a third party, hire, discuss employment with, or recommend to any third party the employment of any employee of the Company, or any of its affiliates, who was actively employed by the Company or an affiliate on the Effective Date without regard to whether that employee has subsequently terminated his or her employment with the Company.

 

 
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2.2 NON-DISCLOSURE. At all times after the Effective Date, the Executive will keep confidential any confidential or proprietary information of the Company and its affiliates which is now known to him or which hereafter may become known to him as a result of his employment or association with the Company and shall not at any time directly or indirectly disclose any such information to any person, firm or Company, or use the same in any way other than in connection with the business of the Company and its affiliates, or pursuant to any duly issued court order or subpoena. For purposes of this Agreement, “confidential or proprietary information” means information unique to the Company and its affiliates which has a significant business purpose and is not known or generally available from sources outside the Company and its affiliates. This Section 2.2 shall survive the termination or expiration of this Agreement for whatever reason.

 

ARTICLE III 

EMPLOYMENT PERIOD

 

3.1 DURATION. The term of this Agreement shall commence on the Effective Date and shall terminate on the One Year Anniversary thereof. The Employment Period shall be contemporaneous with the term of this Agreement, unless terminated early in conformity with Section 3.2 below.

 

3.2 EARLY EMPLOYMENT TERMINATION. The Employment Period shall be terminated prior to the end of the term of this Agreement for any of the following reasons or upon the occurrence of any of the following events:

 

(a) Termination of the Executive’s employment by either party for any reason with thirty (30) days notice to the other party; or

 

(b) Discharge of the Executive for cause as determined by the Board of Directors; or

 

(c) Death of the Executive; or

 

(d) Total Disability of the Executive (as defined in Section 3.4(b) below); or

 

(e) Voluntary resignation of the Executive.

 

3.3 COMPENSATION AND/OR BENEFITS FOLLOWING EARLY EMPLOYMENT TERMINATION.

 

(a) In the event of an early termination of the Employment Period pursuant to Section 3.2, the Executive, or his estate in the event of his death, will receive his base salary at the applicable rate specified in Section 1.2 above through the date of such employment termination.

 

(b) In the event of an early termination of the Employment Period pursuant to Sections 3.2(a), 3.2(c), 3.2(d) or 3.2(e) above, the Executive shall be entitled to retain the Options which have vested prior to the date of the early termination pursuant to Section 1.4 herein, and the Executive’s right to the future issuance of Options pursuant to said Section 1.4 shall terminate immediately.

  

 
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(c) In the event of an early termination of the Employment Period pursuant to Section 3.2(b), the Executive’s right to the future issuance of Options pursuant to Section 1.4 shall terminate immediately and the Executive shall forfeit all unexercised Options immediately.

 

(d) In the event of an early termination of the Employment Period, other than termination for cause, the Company shall pay to the Executive all accrued but unpaid compensation earned by the Executive prior to the date of termination.

 

3.4 DEFINITIONS. The following words shall have the specified meanings when used in the Sections specified:

 

(a) As used in Sections 3.2(a) and 3.2(b) above, the term “cause” means (i) willful and continued non-performance of his job responsibilities, (ii) the Executive’s conviction for a felony, (iii) proven or admitted fraud, misappropriation, theft or embezzlement by the Executive, (iv) the Executive’s inebriation or use of illegal drugs in the course of, related to or connected with the business of the Company, (v) the Executive’s willful engaging in misconduct that is materially injurious to the Company or its affiliates, monetarily or otherwise, or (vi) the breach by the Executive of his obligations under Sections 2.1 or 2.2 above.

 

(b) As used in Section 3.2(d) above, the term “Total Disability” means a physical or mental condition which causes the Executive to be unable to perform substantially all of the duties of his position hereunder for an aggregate of six (6) months in any twelve-month period as reasonably determined by the Company.

 

ARTICLE IV 

NOTICES

 

Any notices requests, demands and other communications provided for by this Agreement shall be sufficient if in writing and if sent by registered or certified mail to the Executive at the last address he has filed in writing with the Company or, in the case of the Company, at its principal offices.

 

ARTICLE V 

MISCELLANEOUS

 

5.1 ENTIRE AGREEMENT. This Agreement constitutes the entire understanding of the Executive and the Company with respect to the subject matter hereof, and supersedes any and all prior understandings on the subjects contained herein, written or oral.

 

5.2 MODIFICATION. This Agreement shall not be varied, altered, modified, canceled, changed, or in any way amended, nor any provision hereof waived, except by mutual agreement of the parties in a written instrument executed by the parties hereto or their legal representatives.

 

5.3 SEVERABILITY. In the event that any provision or portion of this Agreement shall be determined to be invalid or unenforceable for any reason, the remaining provisions of this Agreement shall be unaffected thereby and shall remain in full force and effect, provided, that if the unenforceability of any provision is because of the breadth of its scope, the duration of such provision or the geographical area covered thereby, the parties agree that such provision shall be amended so as to reduce the breadth of the scope or the duration and/or geographical area of such provision such that, in its reduced form, said provision shall then be enforceable.

 

 
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5.4 GOVERNING LAW. The provisions of this Agreement shall be construed and enforced in accordance with the laws of the State of Massachusetts, without regard to any otherwise applicable principles of conflicts of laws.

 

5.5 ARBITRATION. Any dispute or controversy arising under or in connection with this Agreement shall be settled exclusively by arbitration in Boston, Massachusetts in accordance with the rules of the American Arbitration Association then in effect. Judgment may be entered on the arbitrators’ award in any court having jurisdiction.

 

5.6 COUNTERPARTS. This Agreement and any Joint Written Direction may be executed in counterparts, which when so executed shall constitute one and same agreement or direction.

 

[Remainder of page intentionally left blank. Signatures to follow.]

 

 
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IN WITNESS WHEREOF, the parties have executed and delivered this Agreement on the date first above written.

 

  COMPANY:  
 
CELLCEUTIX CORPORATION
       
By /s/ Leo Ehrlich  
  Name:  Leo Ehrlich   
  Title: CEO   

 

  EXECUTIVE:  
       
By:

Dr. William James Alexander

By: /s/ Dr. WJ Alexander  
    307 Whisperwood Drive  
    Cary, NC 27518  

 

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EXHIBIT 99.1

 

Cellceutix Announces Positive Top-Line Data From Phase 2b ABSSSI Trial; Single-Dose Brilacidin Comparable to 7-Days of Daptomycin

 

BEVERLY, MA--(Marketwired - Oct 23, 2014) - Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antibiotic applications, is pleased to announce positive top-line results for its Phase 2b randomized double-blind study comparing three dosing regimens of Brilacidin to daptomycin for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). The trial, which began in February, enrolled 215 subjects, with approximately 25% in each treatment arm. The primary endpoint was clinical success in the intent-to-treat population, defined as reduction of at least 20% in area of ABSSSI lesion, relative to baseline, when observed 48-72 hours after the first dose of study drug, and no rescue antibiotics administered. This is consistent with the 2013 Food and Drug Administration (FDA) guidance for ABSSSI studies and is the same endpoint used in recent approvals for ABSSSI drugs.

 

All three Brilacidin treatment arms (two single-dose regimens and one three-day dose regimen) reached the primary endpoint, with the clinical success rate for each dosing regimen statistically comparable to the clinical success rate of the FDA-approved seven-day dosing regimen of daptomycin. All Brilacidin treatment regimens were well tolerated. There were six severe adverse events (SAE) reported across the study, none of which were considered related to Brilacidin by the principal investigator.

 

Based upon the data, Cellceutix has decided that a pivotal Phase 3 trial in 2015 will be for a single-dose of Brilacidin for ABSSSI. 

 

Brilacidin is the first in a novel class of antibiotics known as defensin-mimetics being developed by Cellceutix. The platform is being used to develop other anti-infective drugs to address areas of high medical need, such as antibiotics for the treatment of resistant Gram-negative infections and fungal infections. 

 

"This is an historic event and a proud day for Cellceutix shareholders as we have proven the efficacy of one dose of our novel drug Brilacidin to be comparable to seven days of therapy with the blockbuster antibiotic daptomycin to treat ABSSSI with zero drug-related SAEs," commented Leo Ehrlich, Chief Executive Officer of Cellceutix. "The implications to the results of the trial are broad reaching and create a tremendous opportunity for our infectious disease division. Because Brilacidin is a novel compound with a unique mechanism of action that can be administered as a single-dose, the potential for the development of resistance is very minimal, if at all, which we believe gives it a competitive edge over any approved antibiotic. The results further validate the potential for our extensive defensin-mimetic franchise as a platform for countless drug-resistant indications, aligning us in what we believe is a prime position to become a leader in anti-infective market."

 

Cellceutix is preparing a poster on the completed Phase 2b clinical trial for presentation at the 25th European Congress of Clinical Microbiology and Infectious Diseases, which will be held from April 25 - 28, 2015 in Copenhagen, Denmark.

 

 
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About Cellceutix:

 

Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antibiotic applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations. Cellceutix will soon begin a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention and treatment of Oral Mucositis. Brilacidin-OM, a defensin mimetic compound, has shown in the laboratory to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol has recently completed a Phase 1 clinical trial and is being readied for a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's key antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data has shown a single dose of Brilacidin to deliver statistically comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site atwww.cellceutix.com.

 

Forward-Looking Statements

 

This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix's need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.

 

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