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): June 26, 2018

 

RITTER PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   001-37428   26-3474527
(State or other jurisdiction   (Commission   (I.R.S. Employer
of incorporation)   File Number)   Identification No.)

 

1880 Century Park East, Suite 1000    
Los Angeles, California   90067
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (310) 203-1000

 

 

 

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))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company [X]

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [  ]

 

 

 

 

 

 

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

 

On June 26, 2018, the board of directors of Ritter Pharmaceuticals, Inc. (the “Company”) appointed Andrew J. Ritter as the Company’s new Chief Executive Officer, effective June 27, 2018, to succeed Michael D. Step, who resigned effective June 27, 2018, as part of a planned transition. Mr. Step will remain on the Company’s board of directors and serve as a consultant for the Company.

 

Andrew J. Ritter, age 35, served as Co-Founder, President and Chief Executive Officer of the Company from its inception in 2004 until relinquishing the role of Chief Executive Officer to Mr. Step in October 2014. Mr. Ritter has been a member of the board of directors of the Company since its inception in 2004. As President, he developed the scientific foundation for the Company and recruited a Medical Board comprised of lactose intolerance and gastrointestinal disease experts. He played a major role in the Company’s initial public offering (the “IPO”) in 2015 and has led the team in additional, successful financing rounds both before and subsequent to the IPO. Mr. Ritter received a Master of Business Administration from the Wharton School of Business. Mr. Ritter is the son of Ira E. Ritter, Executive Chairman, Chief Strategic Officer and Director of the Company.

 

In connection with his appointment to the Chief Executive Officer position, the board of directors approved certain changes to Mr. Ritter’s compensation arrangement with the Company. Effective June 27, 2018, Mr. Ritter’s annual base salary was increased to $450,000. He will also be eligible to receive a target annual bonus equal to 50% of his base salary, as then in effect, as determined by the board of directors. The Company intends to enter into an amended and restated offer letter with Mr. Ritter setting forth these changes, and will file such amended and restated offer letter as an exhibit to the Company’s quarterly report on Form 10-Q for the quarter ending June 30, 2018.

 

In connection with his promotion, Mr. Ritter was also granted a stock option to purchase 150,000 shares of the Company’s common stock at an exercise price of $2.73 per share, the closing price of the Company’s stock on the date of grant (the “CEO Option”). The CEO Option will vest and be exercisable in 48 equal monthly installments beginning on July 26, 2018, subject to his continued employment with the Company, and will be exercisable for a ten year term commencing on the date of grant.

 

In connection with his resignation as Chief Executive Officer, on June 30, 2018 (the “Separation Agreement Effective Date”), the Company and Mr. Step entered into an Agreement and General Release (the “Separation Agreement”) and a Consulting Agreement (the “Consulting Agreement”).

 

Under the terms of the Separation Agreement, the Company will pay Mr. Step $300,000 within 60 days of the Separation Agreement Effective Date, in exchange for his execution of a general release against the Company. The Separation Agreement also provides for COBRA continuation coverage under the Company’s medical insurance plan for 12 months, and clarifies that all stock options held by Mr. Step will continue to vest in accordance with their terms for so long as Mr. Step continues to serve as a consultant to, director of and/or service provider to the Company.

 

Pursuant to the terms of the Consulting Agreement, Mr. Step has agreed to provide consulting services to the Company from time to time, as requested by the Company, for an initial term of 12 months, which may be extended upon the mutual agreement of the parties in writing. Under the terms of the Consulting Agreement, Mr. Step will be paid $11,250 per month for his services and will be reimbursed for his actual expenses. Mr. Step may terminate the Consulting Agreement for any reason by giving the Company at least 14 days’ prior written notice. The Company may terminate the Consulting Agreement for Cause (as defined in the Consulting Agreement).

 

The Separation Agreement and Consulting Agreement each contain confidentiality and non-disparagement restrictions which apply indefinitely. The Consulting Agreement also contains non-solicitation restrictions that apply during the term of the Consulting Agreement and for one year after its termination.

 

The foregoing description of the Separation Agreement and the Consulting Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Separation Agreement and the Consulting Agreement, which are filed as exhibits to this Current Report on Form 8-K (this “Report”) as Exhibits 10.1 and 10.2, respectively, and are incorporated herein by reference.

 

 

 

 

Item 8.01. Other Events.

 

On June 27, 2018, the Company issued a press release announcing the appointment of Andrew J. Ritter as the Company’s new Chief Executive Officer. A copy of the press release is attached as Exhibit 99.1 to this Report and is incorporated herein by reference.

 

Also on June 27, 2018, the Company issued a press release announcing the commencement of the Company’s first pivotal Phase 3 clinical trial for RP-G28 for the treatment of lactose intolerance with the enrollment of its first patient. A copy of the press release is attached as Exhibit 99.2 to this Report and is incorporated herein by reference.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Description
     
10.1   Agreement and General Release, dated June 26, 2018, by and between Ritter Pharmaceuticals, Inc. and Michael D. Step
     
10.2   Consulting Agreement, dated June 26, 2018, by and between Ritter Pharmaceuticals, Inc. and Michael D. Step
     
99.1   Press Release dated June 27, 2018, entitled “Ritter Pharmaceuticals Announces the Appointment of Andrew J. Ritter and Chief Executive Officer”
     
99.2   Press Release dated June 27, 2018, entitled “Ritter Pharmaceuticals Initiates First Pivotal Phase 3 Trial for RP-G28 for the Treatment of Lactose Intolerance”

 

 

 

 

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.

 

  RITTER PHARMACEUTICALS, INC.
     
  By: /s/ Andrew J. Ritter                    
  Name: Andrew J. Ritter
  Title: President and Chief Executive Officer
     
Date: July 2, 2018    

 

 

 

 

Exhibit 10.1

 

AGREEMENT AND GENERAL RELEASE

 

Ritter Pharmaceuticals, Inc. (the “Company”) and Michael D. Step (the “Employee”), agree that:

 

1. Last Day of Employment . Employee’s last day of employment with the Company will be June 26, 2018.
   
2. Consideration . In consideration for signing this Agreement and General Release (this “Agreement”), and complying with its terms, the Company agrees to:

 

  (a) Pay to Employee, in accordance with the following sentence, Three Hundred Thousand Dollars ($300,000.00), less lawful deductions, conditional upon the Company’s receipt of an original of this Agreement signed by Employee and the Company’s receipt of a letter from Employee in the form attached hereto as Exhibit “A.” This sum will be paid to Employee within sixty (60) days of the date hereof, subject to the Company’s receipt of the documentation required under the prior sentence.
     
  (b)

Pay to the Employee Eight Thousand Seven Hundred Thirty and 54/100 Dollars ($8,730.54) (subject to adjustment to reflect any increase or decrease in the amount of the premium for such coverage) for premium payments for COBRA continuation coverage for a period of twelve (12) months within sixty (60) days of the date hereof, provided that Employee properly elects COBRA continuation coverage under Company’s medical insurance plan.

     
  (c) Enter into a one-year Consulting Agreement with Employee in substantially the form attached hereto as Exhibit “B” (the “Consulting Agreement”).

 

3. No Consideration Absent Execution of this Agreement and General Release . Employee understands and agrees that Employee would not receive the monies and/or benefits specified in Section 2 above, except for Employee’s execution of this Agreement and General Release and the fulfillment of the promises contained herein.
   
4.

Receipt of All Wages Due; Termination of Executive Severance & Change In Control Agreement. Employee and the Company acknowledge and agree that the Company has paid all wages and compensation due and owing to Employee as of the date hereof, including, without limitation, any and all of Employee’s accrued but unused vacation, all bonus, profit participation, commissions, or other variable compensation, and all reimbursable expenses, and any and all fees, penalties, accrued interest or other charges of any nature associated with the foregoing. Employee and the Company acknowledge and agree that upon the Effective Date (as defined below) that certain Executive Severance & Change In Control Agreement, dated as of December 1, 2014, by and between Employee and the Company shall terminate and be of no further force or effect.

   
5. Taxes . The Company will withhold required federal, state, and local taxes from any and all payments contemplated by this Agreement. Other than the Company’s obligation and right to withhold, Employee will be responsible for any and all taxes, interest, and penalties that may be imposed with respect to the payments contemplated by this Agreement (including, but not limited to, those imposed under Internal Revenue Code Section 409A).

 

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6. Vesting of Stock Options.   Employee and the Company acknowledge and agree that all options to purchase shares of the Common Stock of the Company held by Employee shall continue to vest in accordance with their terms for so long as Employee continues to serve as a consultant to, Director of and/or service provider to the Company.
   
7. Nondisclosure of Confidential Information . Employee shall continue to maintain the confidentiality of all confidential and proprietary information of the Company, and shall not use such confidential and proprietary information for any purpose other than as approved or directed by the Company.
   
8. Release of Claims . Employee agrees that the Additional Consideration provided for in this Agreement represents settlement in full of all outstanding obligations owed to Employee by the Company, its officers, managers, supervisors, members, agents and employees. Employee, on Employee’s own behalf, and on behalf of Employee’s heirs, representatives, executors, administrators, attorneys, family members, executors, agents, successors in interest, and assigns, hereby fully, knowingly and forever releases the Company and their past, present and future owners, parents, subsidiaries, divisions, affiliates, future affiliates, related entities, joint ventures, partners and members, as well as each of their respective past, present and future directors, officers, investors, shareholders, administrators, agents, associates, representatives, employees, attorneys, predecessors, successors and assigns, and any and all of them (the “Releasees”) from any and all liability, actions, causes of action, claims, charges, complaints, demands, grievances, promises, obligations, losses, damages, injuries and legal responsibilities, of any type whatsoever, whether known or unknown, unforeseen, unanticipated, unsuspected or latent, that are based upon, relate to or arise out of any matters of any kind (collectively, “Claims”), that Employee may possess arising from any omissions, acts or facts that have occurred up until and including the Effective Date of this Agreement including, without limitation:

 

  (a) any and all claims relating to or arising from Employee’s employment relationship with the Company and the termination of that relationship, including, without limitation, any employment agreements and the termination of those employment agreements; and
     
  (b) any and all claims under the law of any jurisdiction including, but not limited to, wrongful discharge of employment, retaliation, constructive discharge from employment, termination in violation of public policy, discrimination, harassment, breach of contract (both express and implied), breach of a covenant of good faith and fair dealing (both express and implied), whistleblowing claims, promissory estoppel, negligent or intentional infliction of emotional distress, negligent or intentional misrepresentation, negligent or intentional interference with contract or prospective economic advantage, fraud, breach of fiduciary duty, breach of the duty of loyalty, unfair business practices, defamation, libel, slander, negligence, personal injury, assault, battery, invasion of privacy, false imprisonment, and conversion; and

 

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  (c) any and all claims for violation of any federal, state or municipal statute, laws, or ordinances, including, but not limited to, Title VII of the Civil Rights Act of 1964, the Civil Rights Act of 1991, the Age Discrimination in Employment Act of 1967, the Americans with Disabilities Act of 1990, the Fair Labor Standards Act, the Employee Retirement Income Security Act of 1974, the Worker Adjustment and Retraining Notification Act, the Older Workers Benefit Protection Act, the Family and Medical Leave Act, the California Family Rights Act, the California Fair Employment and Housing Act, and the California Labor Code, Section 1981 of the Civil Rights Act of 1866, the Equal Pay Act of 1963, the Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA), Employee Order 11141, the Employee Retirement Income Security Act of 1974, the California Civil Code, the California Business & Professions Code, the Code of Federal Regulations, the California Code of Regulations, and any applicable California Industrial Welfare Commission Order; and
     
  (d) any and all claims for violation of the federal, or any state, constitution; and
     
  (e) any and all claims arising out of any other laws and regulations relating to compensation, wages and hours of work, leaves, employment or employment discrimination, harassment or retaliation; and
     
  (f) any claim for any loss, cost, damage, or expense arising out of any dispute over the non-withholding or other tax treatment of any of the proceeds received by Employee as a result of this Agreement; and
     
  (g) any claim as to any equity interest in the Company or its subsidiaries, or any option or right with respect thereto; and
     
  (h) any claim for profit participation, bonus payments, commissions, or other variable compensation; and
     
  (i) any claim relating to late payment of any amount due; and
     
  (j) any and all claims for attorneys’ fees and costs.

 

The Company and Employee agree that the release set forth in this Section shall be and remain in effect in all respects as a complete general release as to the matters released. This release does not extend to any obligations incurred under this Agreement.

 

This release is not intended to operate as, nor shall be construed as, a release or waiver of any rights and/or claims that cannot be released or waived as a matter of law. This release does not prohibit Employee from filing a charge with the Equal Employment Opportunity Commission (the “EEOC”) or equivalent state agency in Employee’s state or participating in an EEOC or state agency investigation. Employee agrees to waive his right to monetary or other recovery should any claim be pursued with the EEOC, state agency, or any other federal, state or local administrative agency on Employee’s behalf arising out of or related to Employee’s employment with and/or separation from the Company.

 

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9. Acknowledgement of Waiver of Claims Under ADEA . Employee acknowledges that Employee is waiving and releasing any rights Employee may have under the Age Discrimination in Employment Act of 1967 (“ADEA”) and that this waiver and release is knowing and voluntary. Employee and the Company agree that this waiver and release does not apply to any rights or claims that may arise under ADEA after the Effective Date of this Agreement. Employee acknowledges that the consideration given for this waiver and release Agreement is in addition to anything of value to which Employee was already entitled. Employee further acknowledges that Employee has been advised by this writing that:

 

  (a) he should consult with an attorney prior to executing this Agreement; and
     
  (b) he has up to twenty-one (21) days within which to consider this Agreement; and
     
  (c) to the extent that he takes less than twenty-one (21) days to consider this Agreement prior to execution, Employee acknowledges that he had sufficient time to consider this Agreement and that he expressly, voluntarily and knowingly waives any additional time; and
     
  (d) he has seven (7) days following his execution of this Agreement to revoke the Agreement; and
     
  (e) this Agreement shall not be effective until the revocation period has expired; and
     
  (f) nothing in this Agreement prevents or precludes him from challenging or seeking a determination in good faith of the validity of this waiver under the ADEA, nor does it impose any condition precedent, penalties or costs from doing so, unless specifically authorized by federal law.

 

Any revocation of this Agreement under Section 9(d) must be in writing and sent within the stated time period to Andrew J. Ritter, President & Chief Executive Officer, 1880 Century Park East #1000, Los Angeles, California 90067.

 

This release is not intended to operate as, nor shall be construed as, a release or waiver of any rights and/or claims that cannot be released or waived as a matter of law.

 

10. Civil Code Section 1542 . Employee represents that Employee is not aware of any claim by Employee other than the claims that are released by this Agreement. Employee acknowledges that Employee has had the opportunity to be advised by legal counsel and is familiar with the provisions of California Civil Code Section 1542, which provides as follows:

 

A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS WHICH THE CREDITOR DOES NOT KNOW OR SUSPECT TO EXIST IN HIS OR HER FAVOR AT THE TIME OF EXECUTING THE RELEASE, WHICH IF KNOWN BY HIM OR HER MUST HAVE MATERIALLY AFFECTED HIS OR HER SETTLEMENT WITH THE DEBTOR.

 

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Employee, being aware of said code section, agrees to expressly waive any rights Employee may have thereunder, as well as under any other statute or common law principles of similar effect.

 

11. No Pending or Future Lawsuits . Employee represents that he has no lawsuits, Claims, or actions pending in his name, or on behalf of any other person or entity, against the Company or any other person or entity referred to herein. Employee also represents that he will not bring any Claims on his own behalf or on behalf of any other person or entity against the Company, the Releasees, or any other person or entity referred to herein.
   
12. Confidentiality . The Parties acknowledge that Employee’s agreement to keep the terms and conditions of this Agreement confidential, and to refrain from any defamation or disparagement of the Company, including its officers and directors, is a material factor on which all Parties relied in entering into this Agreement. Employee hereto agrees to use his best efforts to maintain in confidence the existence of this Agreement, the contents and terms of this Agreement, and the consideration for this Agreement.

 

Notwithstanding the foregoing, the Parties acknowledge this Agreement does not limit Employee’s ability to communicate with any local, state, or federal government agencies or otherwise participate in any investigation or proceeding that may be conducted by any government agency, including providing documents or other information. The parties further acknowledge that this Agreement does not limit Employee’s right to receive an award for information provided to any government agencies. Notwithstanding the foregoing, Employee agrees to waive his right to recover monetary damages in any charge, complaint, or lawsuit filed by him or by anyone else on his behalf.

 

13. No Cooperation . Employee agrees that he will not act in any manner that might damage the business of the Company. Employee agrees that he will not encourage, counsel, or assist any attorneys or their clients in the presentation or prosecution of any disputes, differences, grievances, claims, charges, or complaints by any third party against any of the Releasees, unless under a subpoena or other court order to do so. Employee shall inform the Company in writing within three (3) days of receiving any such subpoena or other court order.
   
14. Non-Disparagement . Employee agrees that he will not at any time hereafter make any statements, either verbal or written to anyone, including without limitation, any electronic or print news media or other publications, or any community organizations, which would malign, defame or disparage the reputation, image, good will or commercial interest of the parties or any of the Releasees.

 

Notwithstanding the foregoing, the Parties acknowledge this Agreement does not limit Employee’s ability to communicate with any local, state, or federal government agencies or otherwise participate in any investigation or proceeding that may be conducted by any government agency, including providing documents or other information. The parties further acknowledge that this Agreement does not limit Employee’s right to receive an award for information provided to any government agencies. Notwithstanding the foregoing, Employee agrees to waive his right to recover monetary damages in any charge, complaint, or lawsuit filed by him or by anyone else on his behalf.

 

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15. Breach . Employee acknowledges and agrees that any breach of any provision of this Agreement shall entitle the Company immediately to recover and/or cease the severance benefits provided to Employee under this Agreement and will further entitle the Company and/or its officers and/or its directors to recover any additional damages, including attorney’s fees and costs, allowed by law. Employee shall also be responsible to the Company and/or its officers and/or its directors for all costs, attorneys’ fees and any and all damages incurred by the Company (a) enforcing the obligation, including the bringing of any suit to recover the monetary consideration, and (b) defending against a claim or suit brought or pursued by Employee in violation of this Agreement.
   
16. No Admission of Liability . The Parties understand and acknowledge that this Agreement constitutes a compromise and settlement of actual or potential disputed claims. No action taken by the Parties hereto, or either of them, either previously or in connection with this Agreement shall be deemed or construed to be:

 

  (a) an admission of the truth or falsity of any claims made or any potential claims; or
     
  (b) an acknowledgment or admission by either party of any fault or liability whatsoever to the other party or to any third party.

 

17. Costs . The Parties shall each bear their own costs, expert fees, attorneys’ fees and other fees incurred in connection with this Agreement, except as provided herein.
   
18. Arbitration . The Parties agree that any and all disputes arising out of the terms of this Agreement, their interpretation, and any of the matters herein released, shall be subject to binding arbitration in Los Angeles County before the Judicial Arbitration & Mediation Services, Inc. (JAMS) pursuant to its employment arbitration rules and procedures, in accordance with the Federal Arbitration Act. The Parties agree that the prevailing party in any arbitration shall be entitled to injunctive relief in any court of competent jurisdiction to enforce the arbitration award. The Parties agree that the prevailing party in any arbitration shall be awarded its reasonable attorneys’ fees and costs. The Parties hereby agree to waive their right to have any dispute between them resolved in a court of law by a judge or jury. This Section will not prevent either party from seeking injunctive relief (or any other provisional remedy) from any court having jurisdiction over the Parties and the subject matter of their dispute relating to the obligations of either of the Parties under this Agreement and surviving provisions of the Non-Disclosure Agreement or Offer Letter.
   
19. No Reemployment . Employee hereby waives any and all rights to employment or re-employment with the Company or any successor or affiliated organization (“Related Entity”). Employee agrees that the Company and the Related Entities have no obligation, contractual or otherwise, to employ or re-employ Employee, now or in the future, either directly or indirectly, on a full-time, part-time, or temporary basis, including, but not limited to, utilizing Employee’s services as a temporary employee, worker, or contractor through any temporary service providers, vendors, or agencies.
   
20. Authority . Each the Company and Employee represents and warrants that they have the capacity to act on their own behalf and on behalf of all who might claim through them and to bind them to the terms and conditions of this Agreement. Each party warrants and represents that there are no liens or claims of lien or assignments in law or equity or otherwise of or against any of the Claims or causes of action released herein.

 

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21. No Representations . Each party represents that it has had the opportunity to consult with an attorney, and has carefully read and understands the scope and effect of the provisions of this Agreement. In entering into this Agreement, neither party has relied upon any representations or statements made by the other party hereto which are not specifically set forth in this Agreement. Further, Employee acknowledges and agrees that Employee has made such investigation of the facts pertaining to this Agreement and all matters contained herein as Employee deems necessary, desirable or appropriate and agrees that the release provided for herein shall remain in all respects effective and enforceable and not subject to termination or rescission by reason of any later discovery of new, different or additional facts.
   
22. Severability . In the event that any provision, or any portion thereof, becomes or is declared by a court of competent jurisdiction to be illegal, unenforceable or void, this Agreement shall continue in full force and effect without said provision or portion of said provision.
   
23. Entire Agreement . This Agreement ( along with the Consulting Agreement ) represents the entire agreement and understanding between the Company and Employee concerning the subject matter of this Agreement and Employee’s relationship with the Company, and supersedes and replaces any and all prior agreements and understandings between the Parties concerning the subject matter of this Agreement and Employee’s relationship with the Company.
   
24. No Waiver . The failure of the Company to insist upon the performance of any of the terms and conditions in this Agreement, or the failure to prosecute any breach of any of the terms and conditions of this Agreement, shall not be construed thereafter as a waiver of any such terms or conditions. This entire Agreement shall remain in full force and effect as if no such forbearance or failure of performance had occurred.
   
25. No Oral Modification . This Agreement may only be amended in a writing signed by Employee and the Company.
   
26. Governing Law . This Agreement shall be construed, interpreted, governed, and enforced in accordance with the laws of the State of California, without regard to choice-of-law provisions. Employee hereby consents to personal and exclusive jurisdiction and venue in the State of California.
   
27. Effective Date . This Agreement will become effective seven (7) calendar days after the date on which it is last signed below (the “Effective Date”), unless revoked in writing by Employee prior to that time in accordance with Section 9 of this Agreement.
   
28. Counterparts . This Agreement may be executed in counterparts, and each counterpart shall have the same force and effect as an original and shall constitute an effective, binding agreement on the part of each of the undersigned.

 

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29. Voluntary Execution of Agreement . This Agreement is executed voluntarily and without any duress or undue influence on the part or behalf of the Parties hereto, with the full intent of releasing all claims. The Parties acknowledge that:

 

  (a) They have read this Agreement, and have had a full and ample opportunity to study this Agreement; and
     
  (b) They have been represented in the preparation, negotiation, and execution of this Agreement by legal counsel of their own choice or that they have voluntarily declined to seek such counsel; and
     
  (c) They understand the terms and consequences of this Agreement and of the releases it contains; and
     
  (d) They are fully aware of the legal and binding effect of this Agreement.

 

[ Signature page follows .]

 

IN WITNESS WHEREOF, the Parties have executed this Agreement on the respective dates set forth below.

 

RITTER PHARMACEUTICALS, INC.   EMPLOYEE
                                                                                        
Dated: June 30, 2018   Dated: June 29, 2018
         
By: /s/ Andrew J. Ritter     /s/ Michael D. Step
  Andrew J. Ritter, President     Michael D. Step
  & Chief Executive Officer    

 

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EXHIBIT A

 

June __, 2018

 

Ritter Pharmaceuticals, Inc.

1880 Century Park East #1000

Los Angeles, CA 90067

Attention: Andrew J. Ritter, President & Chief Executive Officer

 

Re: Agreement and General Release

 

Dear Andrew:

 

On June ___, 2018, I signed an Agreement and General Release between Ritter Pharmaceuticals, Inc. and me. I was advised in writing by Ritter Pharmaceuticals, Inc. to consult with an attorney of my choosing, prior to executing this Agreement and General Release.

 

More than seven (7) calendar days have elapsed since I executed the above-mentioned Agreement and General Release. I have not revoked my acceptance or execution of that Agreement and General Release and hereby reaffirm my acceptance of that Agreement and General Release up through the date of this letter.

 

Very truly yours,    
     
     
Michael D. Step    

 

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EXHIBIT B

 
See Attached Consulting Agreement

 

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Exhibit 10.2

 

CONSULTING AGREEMENT

 

T his C onsulting A greement (the “Agreement”) is made and entered into by and between Ritter Pharmaceuticals, Inc., a Delaware corporation with a place of business at 1880 Century Park East #1000, Los Angeles, CA 90067 (the “Company”), and Michael D. Step, with an address at 7688 Northern Lights, San Diego, CA 92127 (“Consultant”), effective as of June 27, 2018 (“Effective Date”).

 

R ecitals

 

W hereas , Consultant has been employed and served as the Chief Executive Officer of the Company since October 1, 2014; and

 

W hereas, on June 26, 2018 Consultant resigned as an employee and the Chief Executive Officer of the Company; and

 

W hereas , the Company desires that Consultant continue to advise and consult with the Company and Consultant agrees to provide such assistance to the Company through a consulting relationship with the Company;

 

N ow T herefore , in consideration of the mutual obligations specified in this Agreement, the parties agree to the following:

 

1. Consulting Services Engagement . The Company hereby retains Consultant and Consultant hereby accepts such retention to perform consulting services for the Company as set forth herein.

 

1.1 Scope of Services/Term . Consultant shall consult with and advise the senior management team of the Company. with respect to the matters forth on Exhibit A (“Services”) . Consultant shall provide the Services at such times as shall be reasonably requested by the Company. The initial term of this Agreement shall begin on June 27, 2018 and shall continue until June 26, 2019 unless terminated prior thereto pursuant to Section 6 below. The term of this Agreement may be extended upon mutual agreement of the parties in writing.

 

1.2 Professional Standards . The manner and means used by Consultant to perform the Services desired by the Company shall be as mutually agreed to by the Company and Consultant; and such services shall be rendered at such locations as are mutually agreed to by the parties. The Services will be performed in accordance with the standard of care usually and reasonably expected in the performance of such activities and in a professional and workmanlike manner.

 

1.3 Independent Contractor Status . It is understood and agreed that Consultant is an independent contractor, is not an agent or employee of the Company, and is not authorized to act on behalf of the Company. Consultant agrees not to hold himself out as, or give any person any reason to believe that it is the agent, joint venturer or partner of the Company. All income and other taxes, insurance, and benefits shall be the sole responsibility of Consultant and the Company shall not deduct or withhold from any amounts payable to Consultant for taxes. Consultant shall not be employee of Company and will not be entitled to participate in or receive any benefit or right as a Company employee under any Company employee benefit and welfare plans, including, without limitation, employee insurance, pension, savings and security plans as a result of his/her entering into this Agreement.

 

 
 

 

2. Compensation. In consideration of Consultant’s performance of the Services, the Company shall pay Eleven Thousand Two Hundred Fifty Dollars ($11,250.00) a month, which amount shall be paid on the last business day of each month.

 

3. Expenses. Consultant shall be reimbursed for any expenses actually incurred by him in providing the Services provided that any expenses in excess of five hundred dollars ($500.00) are approved in advance by the Company. Consultant shall provide the Company with a written expense report, complete with receipts or other reasonable documentation as may be requested by the Company, for all such expenses requested for reimbursement, which expenses report will be submitted electronically.

 

4. No Solicitation. During the term of this Agreement and for one (1) year after its termination, Consultant shall not affirmatively recruit, solicit or make initial contact with any employee of the Company for the purpose of discussing or offering employment, without the prior written consent of the Company. This provision does not, however, preclude Consultant from undertaking the following: (i) discussing employment with, or offering employment to, an employee of the Company when discussions or negotiations leading to such an offer have been initiated by the employee him/herself, or in the event of the Company’s insolvency, bankruptcy, receivership or any other cessation of business as an ongoing concern; or (ii) advertising in publications of general circulation, posting vacancy announcements, or conducting job fairs which may lead to contacts between the Consultant and employees of the Company.

 

5. Inventions and Confidential Information.

 

5.1 Disclosure of Inventions . Consultant shall promptly and fully disclose to the Company any and all ideas, improvements, inventions, know-how, information, techniques and works of authorship learned, conceived and reduced to practice or resulting from the Services performed by Consultant under this Agreement (“Service Product”). Consultant agrees to keep and maintain adequate and current records (in the form of notes, sketches, drawings or in any other form that may be required by the Company) of all work performed relating to the Services, including all proprietary information developed relating thereto, and such records shall be available to and remain the sole property of the Company at all times.

 

5.2 Inventions Assigned to the Company . Consultant agrees that, any and all Service Product shall be the sole and exclusive property of the Company. Consultant hereby assigns to the Company all of his right, title and interest in and to any and all Service Product. Consultant explicitly acknowledges and agrees that all works of authorship contained in the Service Product are “works for hire” under the copyright laws of the United States, and that the Company shall own the copyright in all such works of authorship. Consultant further agrees that, except for any prior rights held by Consultant, the Company is and shall be vested with all rights, title and interests, including patent, copyright, trade secret and trademark rights, in all of the Service Product under this Agreement.

 

5.3 Obtaining Intellectual Property Protection . During the Term, Consultant agrees to assist the Company in every proper way to obtain and enforce United States and foreign proprietary rights relating to the Service Product in any and all countries. To that end, Consultant agrees to execute, verify and deliver such documents and perform such other acts (including appearing as a witness) as the Company may reasonably request for use in applying for, obtaining, perfecting, evidencing, sustaining and enforcing such proprietary rights and the assignment thereof, at the Company’s expense. In addition, Consultant agrees to execute, verify and deliver assignments of such proprietary rights to the Company or its designee. Consultant’s obligation to assist the Company with respect to proprietary rights in any and all countries shall continue beyond the termination of this engagement, but the Company shall compensate Consultant at a reasonable rate after such termination for the time actually spent by Consultant at the Company’s request on such assistance.

 

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In the event the Company is unable for any reason, after reasonable effort, to secure Consultant’s signature on any document needed in connection with the actions specified in the preceding paragraph, Consultant hereby irrevocably designates and appoints the Company and its duly authorized officers and agents as its agent and attorney in fact, to act for and in its behalf to execute, verify and file, with the same legal force and effect as if executed by it, any such documents and to do all other lawfully permitted acts to further the purposes of the preceding paragraph. Consultant hereby waives and quitclaims to the Company any and all claims of any nature whatsoever which Consultant now or may hereafter have for infringement of any proprietary rights assigned to the Company.

 

5.4 Confidential Information. The term “Confidential Information” means any proprietary information, technical data, trade secrets or know-how, including, but not limited to, research, product plans, products, services, suppliers, supplier lists, customers, customer lists, markets, software, algorithms, implementation strategy, developments, inventions, chemical structures, processes, formulas, technology, designs, drawings, engineering, hardware configuration information, marketing, finances or other business information disclosed by the Company either directly or indirectly in writing, orally or by drawings or inspection of parts or equipment. Confidential Information does not include information which (i) has become publicly known and made generally available through no wrongful act of Consultant, (ii) has been rightfully received by Consultant from a third party that is not an agent or representative of the Company, and who is authorized to make such disclosure, or (iii) is developed independently by Consultant, as evidenced in writing by Consultant’s records, without reference to Confidential Information. Consultant will not, during or for five (5) years after the termination or expiration of this Agreement, use the Company’s Confidential Information for any purpose whatsoever, other than the performance of the Services on behalf of the Company, or disclose the Company’s Confidential Information to any third party without the Company’s prior express written consent. It is understood that the Confidential Information will remain the sole property of the Company. Consultant further agrees to take all reasonable precautions to prevent any unauthorized disclosure of the Confidential Information, including, but not limited to, having each employee, agent or representative of Consultant, if any, with access to any Confidential Information execute a nondisclosure agreement containing provisions in the Company’s favor substantially similar to Sections 5.4 and 5.6 of this Agreement. Consultant will not, during or subsequent to the term of this Agreement, take data or materials from the premises of the Company unless specifically authorized to do so, such authorization to be determined on a case-by-case basis. Upon the termination of this Agreement, or upon Company’s earlier request, Consultant will deliver to the Company all of the Company’s property or Confidential Information in tangible form that Consultant may have in Consultant’s possession or control.

 

5.5 Other Employer Information . Consultant agrees that he will not, during his engagement with the Company, improperly use or disclose any proprietary information or trade secrets of his former or concurrent employers or companies with which he has consulted or is consulting, if any, and that he will not bring onto the premises of the Company any unpublished documents or any property belonging to his former or concurrent employers or companies with which he has consulted or is consulting unless consented to in writing by said employers or companies.

 

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5.6 Third Party Information . Consultant recognizes that the Company has received and in the future will receive confidential or proprietary information from third parties subject to a duty on the Company’s part to maintain the confidentiality of such information and, in some cases, to use it only for certain limited purposes. Consultant agrees that he owes the Company and such third parties, both during the term of his engagement and thereafter, a duty to hold all such confidential or proprietary information in the strictest confidence and not to disclose it to any person or entity (except in a manner that is consistent with the Company’s agreement with the third party) or use it for the benefit of anyone other than the Company or such third party (consistent with the Company’s agreement with the third party).

 

6. Termination .

 

6.1 Termination by the Company . The Company may only terminate this Agreement for Cause. For purposes hereof, “Cause” shall mean a finding by the Company that Consultant has (i) been convicted of a felony or crime involving moral turpitude; (ii) disclosed trade secrets or confidential information of the Company to persons not entitled to receive such information; (iii) engaged in conduct in connection with Consultant’s service to the Company (or any parent or subsidiary), that has, or could reasonably be expected to result in, material injury to the business or reputation of the Company, including, without limitation, act(s) of fraud, embezzlement, misappropriation and breach of duty; (iv) violated the operating and ethics policies of the Company in any material way, including, but not limited to those relating to sexual harassment and the disclosure or misuse of confidential information; (v) engaged in willful and continued negligence in the performance of the services , after Consultant has received notice of and failed to cure such negligence; or (vi) breach any material provision of any agreement between Consultant and the Company, including, without limitation, any confidentiality agreement.

 

6.2 Termination by Consultant. Consultant may terminate this Agreement (i) for any reason whatsoever at any time by giving the Company fourteen (14) days’ prior written notice.

 

6.3 Effect of Termination . Upon any expiration or termination of this Agreement, all rights and obligations of the parties hereunder shall terminate and be of no further force or effect, except as otherwise expressly set forth herein. In the event termination of this Agreement, the parties shall work together in good faith to ensure an orderly cessation of the Services and each party shall return to the other all of its Confidential Information (as defined below) and other materials belonging to the other party. All fees and expenses incurred up to the termination date shall become immediately due and payable. Sections 4, 5, 10, 11.1 and 12-17 of this Agreement shall survive any termination of this Agreement.

 

7. Non-Exclusive Engagement . Consultant represents that he is not a party to any existing agreement which would prevent him from entering into and performing this Agreement. Consultant will not enter into any other agreement that is in conflict with Consultant’s obligations under this Agreement. Subject to the foregoing, Consultant may from time to time act as a consultant to, perform professional services for, or enter into agreements similar to this Agreement with other persons or entities without the necessity of obtaining approval from the Company. The Company may from time to time (i) engage other persons and entities to act as consultants to the Company and perform services for the Company, including services that are similar to the Services, and (ii) enter into agreements similar to this Agreement with other persons or entities, in all cases without the necessity of obtaining approval from Consultant.

 

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8. Compliance with Applicable Laws . Consultant warrants that the Services will be performed in compliance with all applicable laws.

 

9. Assignment; Benefit . This Agreement is for the personal services of Consultant and may not be assigned by Consultant. The Company may assign this Agreement and its rights and obligations hereunder without Consultant’s consent in connection with the transfer or sale of all or substantially all of the Company’s business to which this Agreement relates to a third party, whether by merger, sale of stock, sale of assets or otherwise. No assignment shall relieve either party of the performance of any accrued obligation that such party may then have under this Agreement. Consultant may not delegate or subcontract any of its obligations under this Agreement to any third party without the prior written consent of the Company. The parties’ rights and obligations under this Agreement will bind and inure to the benefit of their respective successors, heirs, executors, and administrators and permitted assigns.

 

10. Indemnification and Limitation of Liability .

 

10.1 By the Company . The Company agrees to indemnify and hold harmless Consultant from and against any liability, damages, loss or expense (including reasonable attorney fees and expenses of litigation) arising out of claims brought by a third party based on or related to (i) the actions of the Company, its employees or any third party acting on behalf or under authorization from the Company in the performance of this Agreement or (ii) any Services performed or products developed or made including the Service Product, except to the extent arising from the negligent or intentionally wrongful acts of Consultant.

 

10.2 By Consultant . Consultant agrees to indemnify and hold harmless the Company against any liability, damages, loss or expense (including reasonable attorney fees and expenses of litigation) arising out of claims brought by a third party based on or related to (i) the actions of Consultant in the performance of this Agreement or (ii) any Services performed or products developed or made including the Service Product, but only to the extent arising from the negligent or intentionally wrongful acts of Company.

 

10.3 Limitation of Liability. In no event will either party be liable to the other for any incidental, indirect, consequential, special, exemplary or punitive damages (including lost sales, lost profits or opportunity costs) regardless of the legal theory asserted even if a party has been advised of the possibility of such damages. Consultant’s maximum aggregate liability under this Agreement or otherwise, will not exceed the amount of professional fees paid by the Company to Consultant in the twelve (12) month period preceding the time giving rise to the claim.

 

11. Warranties; Disclaimer of Warranties .

 

11.1 Warranties . Consultant represents and warrants that he has never been, and shall never be, during the term of this Agreement, excluded from participation in Medicare, Medicaid or any other federal health care program, as defined in 42 U.S.C. § 1320a-7b(f), or been debarred, suspended, proposed for debarment, declared ineligible, or voluntary excluded by any federal department or agency. Consultant represents and warrants that he has not been excluded from any federal contracting by the United States General Services Administration. Consultant further represents and warrants that no final adverse action, as that term is defined in 42 U.S.C. § 1320a-7e(g), has occurred or is pending or threatened against him. Consultant represents and warrants that he is not under investigation by the FDA or any other regulatory agency or debarred pursuant to sections 306(a) and (b) of the Federal Food, Drug Cosmetic Act (“FFDCA”), as described in 21 U.S.C. § 335(a) and (b).

 

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11.2 Disclaimer of Warranties . Except as otherwise set forth herein, Consultant specifically disclaims and makes no representations or warranties, express or implied, as to any matter whatsoever, including without limitation the ownership, merchantability, fitness for a particular purpose, title and non-infringement with respect to the Services performed including the results of such Services or any Service Product provided hereunder. Additionally, Consultant specifically disclaims and makes no representations or warranties regarding the actual or potential misappropriation or infringement of any third party intellectual property rights, and Company acknowledges that the liability for and avoidance of such infringement shall remain the sole and exclusive responsibility of the Company.

 

12. Legal and Equitable Remedies . The parties agree that irreparable damage would occur and that the parties would not have any adequate remedy at law in the event that any of the provisions of this Agreement were not performed in accordance with their specific terms or where otherwise breached. It is accordingly agreed that each party shall be entitled to seek injunctive or other equitable relief, wherever such party deems appropriate, to prevent breaches of this Agreement or to protect such party’s rights under this Agreement. The foregoing remedy is in addition to any other remedy to which the party seeking such equitable relief is entitled to at law.

 

13. Governing Law; Severability. This Agreement shall be governed by and construed according to the laws of the State of California without regard to its conflict of laws rules. If any provision of this Agreement is found by a court of competent jurisdiction to be unenforceable, that provision shall be severed and the remainder of this Agreement shall continue in full force and effect.

 

14. Non-Waiver . The failure of a party to insist upon strict performance of any provision of this Agreement or to exercise any right arising out of this Agreement shall neither impair that provision or right nor constitute a waiver of that provision or right, in whole or in part, in that instance or in any other instance. Any waiver by a party of a particular provision or right shall be in writing, shall be as to a particular matter and, if applicable, for a particular period of time, and shall be signed by such party.

 

15. Counterparts . This Agreement may be executed in counterparts, each of which shall be deemed an original and all of which together shall constitute one instrument.

 

16. Complete Understanding; Modification . This Agreement constitutes the final, exclusive and complete understanding and agreement of the Company and Consultant with respect to the subject matter hereof. Any waiver, modification or amendment of any provision of this Agreement shall be effective only if in writing and signed by Consultant and a Company officer.

 

17. Notices . Any notices required or permitted hereunder shall be given to the appropriate party at the address specified below or at such other address as the party shall specify in writing. Such notice shall be deemed given a) when received, if hand-delivered or sent by a reputable overnight delivery service, (b) when received, if sent by fax and receipt of such fax is confirmed, and (c) three (3) days after the date of mailing if mailed by first class certified or registered mail, postage prepaid, return receipt requested.

 

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If to the Company:

Ritter Pharmaceuticals, Inc.
1880 Century Park East #1000
Los Angeles, CA 90067

 

If to the Consultant:

 

Michael D. Step

7688 Northern Lights

San Diego, CA 92127

 

IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first set forth above.

 

RITTER PHARMACEUTICALS, INC.   CONSULTANT
       
       
By: /s/ Andrew J. Ritter   /s/ Michael D. Step
  Andrew J. Ritter   Michael D. Step
       
  Founder, President and Chief Executive Officer    
  (Title)    

 

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EXHIBIT A

 

Services

 

Consultant shall consult with and advise the senior management team of the Company with respect to:

 

Business Development and Product Development Partnership Opportunities
Strategic Transactions
Investor Relations
Corporate Development
Management and Operational Matters

 

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Exhibit 99.1

 

Ritter Pharmaceuticals Announces Appointment of Andrew J. Ritter as Chief Executive Officer

 

LOS ANGELES (June 27, 2018) – Ritter Pharmaceuticals, Inc. (Nasdaq: RTTR) (“Ritter Pharmaceuticals” or the “Company”), a developer of innovative therapeutic products that modulate the gut microbiome to treat gastrointestinal diseases with an initial focus on the development of RP-G28, a drug candidate with the potential to be the first FDA-approved treatment for lactose intolerance (LI), today announced that Andrew J. Ritter has been appointed to the position of CEO, effective June 27, 2018, succeeding Michael D. Step, who will remain on the Company’s board of directors and serve as a consultant to the company.

 

“As the Company moves forward with the development of RP-G28 by initiating the “Liberatus” study, the first pivotal Phase 3 trial of this important new potential therapy, I am confident that as CEO, Andrew Ritter will continue to guide the Company towards the successful execution and completion of this program,” said departing CEO, Michael D. Step.

 

Andrew Ritter co-founded Ritter Pharmaceuticals in 2007 as a result of his own personal affliction with lactose intolerance. Mr. Ritter directed a team of clinical, manufacturing, and regulatory professionals to develop the Company’s lead product candidate, RP-G28 and, since 2014, he has served as the Company’s President. In this role, he developed the scientific foundation for the Company and recruited a Medical Board comprised of world-class lactose intolerance and gastrointestinal disease experts. He played a major role in the Company’s successful Initial Public Offering (IPO) in 2015 and has led the team in additional, successful financing rounds both before and subsequent to the IPO. Mr. Ritter holds an MBA with an emphasis in Finance from The Wharton School, University of Pennsylvania.

 

Over the past year, Ritter Pharmaceuticals has been diligently building its executive team as it prepares for late stage clinical development of RPG-28. The appointment of Mr. Ritter as CEO comes on the heels of recent key hires, including John Beck, former CFO of Ardea Biosciences as chief financial officer and Diane Plotkin, Ph.D. as vice president of clinical development. Dr. Plotkin brings extensive late-stage clinical development expertise to the team as a result of her prior experiences in similar roles at Merck and ActivX.

 

“Our goal is to make Ritter Pharmaceuticals a leader in gastrointestinal disease treatments. With Andrew Ritter’s planned succession to the role of CEO and these key additions in place, the management team is well positioned to ensure a smooth transition of RP-G28 into Phase 3 development and to create continued shareholder value,” added Ira E. Ritter, co-founder and executive chairman. Finally, I would like to thank Mike Step for his service as the Company’s CEO and we are pleased that he will remain on our Company’s board of directors and continue to work closely with us to help us execute our strategy as a consultant.”

 

 

 

 

About Ritter Pharmaceuticals

 

Ritter Pharmaceuticals, Inc. (www.RitterPharma.com, @RitterPharma) develops novel therapeutic products that modulate the gut microbiome to treat gastrointestinal diseases. The Company’s lead product candidate, RP-G28, has the potential to become the first FDA-approved treatment for lactose intolerance, a condition that affects millions of people worldwide. RP-G28 has been studied in Phase 2 trials and entered Phase 3 clinical development in the second quarter of 2018. The Company is further exploring the therapeutic potential that gut microbiome changes may have on treating/preventing a variety of diseases including: gastrointestinal diseases, cancer, metabolic, and liver disease.

 

Forward-Looking Statements

 

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that express the current beliefs and expectations of Ritter Pharmaceuticals’ management, including statements regarding the management transition and the timing and commencement of our first Phase 3 clinical trial. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. Factors that could affect our actual results are included in the periodic reports on Form 10-K and Form 10-Q that we file with the Securities and Exchange Commission. These forward-looking statements are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise.

 

Contacts

Investor Contact:

John Beck
310-203-1000
john@ritterpharma.com

 

Media Contact:

Jules Abraham
CoreIR

917-885-7378

julesa@coreir.com

 

 

 

 

 

 

Exhibit 99.2

 

Ritter Pharmaceuticals Initiates First Pivotal Phase 3 Trial for RP-G28 for the Treatment of Lactose Intolerance

 

Conference Call Today - June 27, 2018 at 4:30 p.m. ET

 

LOS ANGELES (June 27, 2018) – Ritter Pharmaceuticals, Inc. (Nasdaq: RTTR) (“Ritter Pharmaceuticals” or the “Company”), a developer of innovative therapeutic products that modulate the gut microbiome to treat gastrointestinal diseases with an initial focus on the development of RP-G28, a drug candidate with the potential to be the first FDA-approved treatment for lactose intolerance (LI), today announced that the first patient has been enrolled in the first pivotal Phase 3 clinical trial of RP-G28.

 

“The initiation of this Phase 3 clinical trial for RP-G28, called the “Liberatus” study, is an important milestone not only for the company, but potentially for the way lactose intolerance is treated,” said Andrew J. Ritter, co-founder and president of Ritter Pharmaceuticals, Inc. “To date, there are no prescription drugs available to treat this condition, and we believe that our approach of modulating the microbiome in the gut may have a tremendous impact on the day-to-day lives of millions who suffer from lactose intolerance. We look forward to providing further information and updates on the trial as they become available.”

 

Liberatus Study Design Description:

 

The purpose of this study is to determine the efficacy, safety and tolerability of RP-G28 to treat LI when compared to placebo. The study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in the United States. The estimated enrollment of the trial will be 525 participants conducted at approximately 28 sites. The protocol design includes a 2-week screening period that includes one week of study drug administration, a randomized 30-day study drug treatment period and a 90-day “real world experience” period to assess study drug response and durability of effect after treatment as patients consume their normal diets including dairy products. There will be a second randomized, 30-day, study drug treatment period to assess safety and efficacy of a repeat round of therapy. The primary endpoint of the study will be the mean change in LI symptom composite score 30-days post-treatment compared to baseline. Secondary endpoints will evaluate LI signs and symptoms and global assessment outcomes to evaluate patients’ continued treatment benefit. The study will utilize the prior validated symptom assessment measure and patient questionnaires to capture relevant outcomes. In addition, risk-based data review will be used to monitor and assess potential protocol deviations and site quality indicators.

 

“The Liberatus protocol includes a number of study design improvements and additional site and data safeguards incorporating learnings from previous clinical studies of RP-G28,” said Diane J. Plotkin, vice president of clinical development at the Company. “These modifications aim to help ensure the consistent performance, quality, and integrity of data collected by the multiple sites participating in the study in order to best capture the efficacy and meaningfulness of treatment benefit compared to placebo.”

 

 

 

 

Conference Call

 

Ritter Pharmaceuticals will host a conference call, after market close, today at 4:30p.m. ET (1:30 p.m. PT). The conference call can be accessed by dialing 1-877-270-2148 for domestic callers and 1-412-902-6510 for international callers and requesting the “Ritter Pharmaceuticals Phase 3 Trial Initiation” conference call. The conference call will also be available via webcast in the Investor section of the Company’s website under “Events and Presentations” (http://www.ritterpharmaceuticals.com/investors/events-presentations) and an archive of the teleconference will be available on the website for 90 days following the call.

 

About Ritter Pharmaceuticals

 

Ritter Pharmaceuticals, Inc. (www.RitterPharma.com, @RitterPharma) develops novel therapeutic products that modulate the gut microbiome to treat gastrointestinal diseases. The Company’s lead product candidate, RP-G28, has the potential to become the first FDA-approved treatment for lactose intolerance, a condition that affects millions of people worldwide. RP-G28 has been studied in Phase 2 trials, and is now in Phase 3 clinical development. The Company is further exploring the therapeutic potential that gut microbiome changes may have on treating/preventing a variety of diseases including: gastrointestinal diseases, cancer, metabolic, and liver disease.

 

Forward-Looking Statements

 

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that express the current beliefs and expectations of Ritter Pharmaceuticals’ management, including statements regarding the management transition and the timing and commencement of our first Phase 3 clinical trial. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. Factors that could affect our actual results are included in the periodic reports on Form 10-K and Form 10-Q that we file with the Securities and Exchange Commission. These forward-looking statements are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise.

 

Contacts

Investor Contact:

John Beck
310-203-1000
john@ritterpharma.com

 

Media Contact:

Jules Abraham
CoreIR

917-885-7378

julesa@coreir.com