EXHIBIT 10.1
EMPLOYMENT
AGREEMENT
This
Agreement (the “Agreement”) is made as of June 16, 2016 (the “Effective Date”) by and between Soligenix,
Inc., a Delaware corporation having a place of business at 29 Emmons Drive, Suite C-10, Princeton, NJ 08540 (the “Corporation”),
and Karen Krumeich, an individual (the “Employee”).
W
I T N E S S E T H:
WHEREAS,
the Corporation desires to employ Employee as Senior Vice President and Chief Financial Officer, and the Employee desires to be
employed by the Corporation as Senior Vice President and Chief Financial Officer, all pursuant to the terms and conditions hereinafter
set forth;
NOW,
THEREFORE, in consideration of the foregoing and the mutual promises and covenants herein contained, it is agreed as follows:
I.
EMPLOYMENT
DUTIES
The
Corporation engages and employs Employee, and Employee hereby accepts engagement and employment, as Senior Vice President
and Chief Financial Officer reporting to the Chief Executive Officer of the Corporation. The Employee shall perform high
quality, full-time service to the Corporation to direct, supervise and have responsibility for the administrative, financial,
and risk management operations of the Corporation, including, but not limited to: (i) the development of a financial and
operational strategy and metrics tied to that strategy, and the ongoing development and monitoring of control systems
designed to preserve company assets and report accurate financial results of the Corporation, (ii) managing the other
financial personnel of the Corporation; (iii) evaluating, negotiating, structuring and implementing financial transactions of
the Corporation, (iv) overseeing and managing investor/public relations; and (v) such other duties and responsibilities as
may be reasonably assigned to her by the Chief Executive Officer or the Board of Directors of the Corporation (the
“Board”). Employee acknowledges and understands that her employment may entail significant travel on behalf of
the Corporation.
II.
EMPLOYMENT
TERM
Employee’s
employment hereunder shall be for a period of one (1) year (the “Term”). At the end of the Term, the Term of employment
automatically shall renew for successive one (1) year terms (subject to earlier termination as provided in Section 7 hereof),
unless the Corporation or the Employee delivers written notice to the other at least three (3) months prior to the expiration
hereof of its or her election not to renew the Term of employment.
III.
COMPENSATION
As
compensation for the performance of Employee’s duties on behalf of the Corporation, Employee shall be compensated as follows:
A. The
Corporation shall pay Employee an annual base salary (“Base Salary”) of two hundred twenty two thousand dollars ($222,000)
per annum, payable in accordance with the usual payroll period of the Corporation.
B. The
Corporation shall pay Employee a targeted annual bonus of thirty percent (30%) of the Base Salary, payable at the end of each
calendar year in prorated amount if necessary. Such bonus may be adjusted at the recommendation of the Chief Executive Officer
and by the approval of the Board.
C. Contingent
upon Employee’s acceptance of this Agreement, the Corporation will grant to Employee an option (the “Option”)
to purchase one hundred thousand (100,000) shares of the Corporation’s common stock. The Option shall vest as to twenty
five thousand (25,000) shares immediately and shall vest as to the remainder of the shares on each three (3) month anniversary
of the grant date of the Option at a rate of six thousand two hundred fifty (6,250) shares per quarter while Employee continues
to be employed by Corporation. The exercise price of such Option shall be equal to the market price of the Corporation’s
common stock as of the market close on the business day before the Effective Date of this Agreement. The Option will be granted
pursuant to the Corporation’s 2015 Equity Incentive Plan, as amended, and the Corporation’s standard Stock Option
Agreement. The Option shall be exercisable to purchase vested shares for a period of ninety (90) days following termination, subject
to extension in the discretion of the plan administrator. Upon a Change in Control, all shares underlying the Option shall become
fully vested, and be exercisable for a period of three (3) years after the Change in Control (unless the Option would have expired
sooner pursuant to its natural term). In the event of death of Employee during the Term, all unvested shares underlying the Option
shall immediately vest and remain exercisable for the rest of the Option’s natural term and the Option shall become property
of Employee’s estate. For purposes of this Agreement, the term “Change in Control” shall mean the occurrence
of any of the following events: (i) any “person” (as such term is used in Sections 13(d) and 14(d) of
the Securities Exchange Act of 1934, as amended (the “
Exchange Act
”)) is or becomes a “beneficial owner”
(as defined in Rule 13d-3 under the Exchange Act), directly or indirectly, of securities of the Corporation representing
50% or more of the total power to vote for the election of directors of the Corporation; (ii) during any twelve month period,
individuals who at the beginning of such period constitute the Board and any new director (other than a director designated by
a person who has entered into an agreement with the Corporation to effect a transaction described in clauses (i), (iii), (iv) or
(v) of this sentence) whose election by the Board or nomination for election by the Corporation’s stockholders was
approved by a vote of at least a majority of the directors then still in office who either were directors at the beginning of
the period of whose election or nomination for election was previously approved, cease for any reason to constitute a majority
thereof; (iii) the merger or consolidation of the Corporation with another corporation where the stockholders of the Corporation,
immediately prior to the merger or consolidation, will not beneficially own, immediately after the merger or consolidation, shares
entitling such stockholders to 50% or more of all votes to which all stockholders of the surviving corporation would be entitled
in the election of directors (without consideration of the rights of any class of stock to elect directors by a separate class
vote); (iv) the sale or other disposition of all or substantially all of the assets of the Corporation; (v) a liquidation
or dissolution of the Corporation or (vi) acceptance by stockholders of the Corporation of shares in a share exchange if
the stockholders of the Corporation immediately before such share exchange do not or will not own directly or indirectly immediately
following such share exchange more than fifty percent (50%) of the combined voting power of the outstanding voting securities
of the entity resulting from or surviving such share exchange in substantially the same proportion as their ownership of the voting
securities outstanding immediately before such share exchange.
D. The
Corporation shall withhold all applicable federal, state and local taxes; social security; workers’ compensation contributions;
and such other amounts as may be required by law or agreed upon by the parties with respect to the compensation payable to the
Employee pursuant to Section 3(a) hereof.
E. The
Corporation shall reimburse Employee for all normal, usual and necessary expenses incurred by Employee in furtherance of the business
and affairs of the Corporation, including reasonable travel and entertainment, against receipt by the Corporation of appropriate
vouchers or other proof of Employee’s expenditures and otherwise in accordance with the policy of the Corporation.
F. During
the Term, Employee shall be entitled to a maximum of four (4) weeks paid vacation per annum. Unused vacation may be carried over
to successive years upon approval of the Chief Executive Officer consistent with corporate policy.
G. The
Corporation shall make available to Employee and her dependents such medical, disability, life insurance and such other benefits
as the Corporation makes available to its other senior officers and directors.
IV.
REPRESENTATIONS
AND WARRANTIES BY EMPLOYEE AND CORPORATION
A. Employee
hereby represents and warrants to the Corporation as follows:
1. Neither
the execution and delivery of this Agreement nor the performance by Employee of her duties and other obligations hereunder violate
or will violate any statute, law, determination or award, or conflict with or constitute a breach or violation (whether immediately,
upon the giving of notice or lapse of time or both) of any prior employment agreement, contract, or other instrument to which
Employee is a party or by which she is bound.
2. Employee
has the full right, power and legal capacity to enter and deliver this Agreement and to perform her duties and other obligations
hereunder. This Agreement constitutes the legal, valid and binding obligation of Employee enforceable against her in accordance
with its terms. No approvals or consents of any persons or entities are required for Employee to execute and deliver this Agreement
or perform her duties and other obligations hereunder.
B. The
Corporation hereby represents and warrants to Employee as follows:
1. The
Corporation is duly organized, validly existing and in good standing under the laws of the State of Delaware, with all requisite
corporate power and authority to own its properties and conduct its business in the manner presently contemplated.
2. The
Corporation has full power and authority to enter into this Agreement and to incur and perform its obligations hereunder. This
Agreement constitutes the legal, valid and binding obligation of the Corporation enforceable against it in accordance with its
terms. Except as expressly set forth herein, no approvals or consents of any persons or entities are required for Corporation
to execute and deliver this Agreement or perform its duties and other obligations hereunder.
3. The
execution, delivery and performance by the Corporation of this Agreement does not conflict with or result in a breach or violation
of or constitute a default under (whether immediately, upon the giving of notice or lapse of time or both) the certificate of
incorporation or by-laws of the Corporation, or any agreement or instrument to which the Corporation is a party or by which the
Corporation or any of its properties may be bound or affected.
V.
NON-COMPETITION
A. Employee
understands and recognizes that her services to the Corporation are special and unique and agrees that, during the term of this
Agreement and for a period of two (2) years following the termination of the Employee’s employment with the Corporation
(or one (1) year in the event that the Employee is terminated within 1 year of the Effective Date), employee shall not in any
manner, directly or indirectly, on behalf of herself or any person, firm, partnership, joint venture, corporation or other business
entity (“Person”), enter into or engage in any business competitive with the Corporation’s business or research
activities, either as an individual for her own account, or as a partner, joint venturer, executive, agent, consultant, salesperson,
officer, director of a Person operating or intending to operate in the area of the use of any of the compounds owned or licensed
by the Corporation during the time of her employ.
B. During
the Term and for two (2) years following the termination of the Employee’s employment with the Corporation, Employee shall
not, directly or indirectly, without the prior written consent of the Corporation:
1. interfere
with, disrupt or attempt to disrupt any past, present or prospective relationship, contractual or otherwise, between the Corporation
and any of its licensors, licensees, clients, customers, suppliers, employees, consultants or other related parties, or solicit
or induce for hire any of the employees or agents of the Corporation, or any such individual who in the past was employed or retained
by the Corporation within six (6) months of the termination of said individual’s employment or retention by the Corporation;
or
2. solicit
or accept employment or be retained by any party who, at any time during the Term of this Agreement (or any renewal or extension
thereof), was a customer or supplier of the Corporation or any of its subsidiaries or affiliates (collectively the “Affiliates”),
or any licensor or licensee thereof where the Employee’s position will be related to the business of the Corporation.
C. In
the event that Employee breaches any provisions of this Section 5 or there is a threatened breach, then, in addition to any other
rights which the Corporation may have, the Corporation shall be entitled without the posting of a bond or other security to injunctive
relief to enforce the restrictions contained herein.
VI.
CONFIDENTIAL
INFORMATION
A. Employee
agrees that during the course of her employment and at any time after termination, she will not disclose or make accessible to
any other person, the Corporation’s or any of its Affiliates’ products, services and technology, both current and
under development, promotion and marketing programs, business plans, lists, customer lists, product or licensing opportunities,
investor lists, trade secrets and other confidential and proprietary business information of the Corporation or the Affiliates.
Employee agrees: (i) not to use any such information for herself or others; and (ii) not to take any such material or reproductions
thereof in any form or media from the Corporation’s facilities at any time during her employment by the Corporation, except
as required in Employee’s duties to the Corporation. Employee agrees immediately to return all such material and reproductions
thereof in her possession to the Corporation upon request and in any event upon termination of employment.
B. Except
with prior written authorization by the Corporation, Employee agrees not to disclose or publish any of the confidential, technical
or business information or material of the Corporation, to any suppliers, licensors, licensees, customers, partners or other third
parties to whom the Corporation owes an obligation of confidence, at any time during or after her employment with the Corporation.
C. Employee
hereby assigns to the Corporation all right, title and interest she may have or acquire in all inventions (including patent rights)
developed by Employee during the term of this Agreement (hereinafter the “Inventions”) and agrees that all Inventions
shall be the sole property of the Corporation and its assigns, and the Corporation and its assigns shall be the sole owner of
all patents, copyrights and other rights in connection therewith. Employee further agrees to assist the Corporation in every proper
way (but at the Corporation’s expense) to obtain and from time to time enforce patents, copyrights or other rights on said
Inventions in any and all countries. Employee hereby irrevocably designates counsel to the Corporation as Employee’s agent
and attorney-in-fact to do all lawful acts necessary to apply for and obtain patents and copyrights and to enforce the Corporation’s
rights under this Section. This Section shall survive the termination of this Agreement for any reason.
D. The
Employee recognizes that in the course of her duties hereunder, she may receive from Affiliates or others information which may
be considered “material, nonpublic information” concerning a public company that is subject to the reporting requirements
of the Exchange Act. The Employee agrees not to:
1. Buy
or sell any security, option, bond or warrant while in possession of relevant material, nonpublic information received from Affiliates
or others in connection herewith;
2. Provide
Affiliates with information with respect to any public company that may be considered material, nonpublic information; or
3. Provide
any person with material, nonpublic information, received from Affiliates, including any relative, associate, or other individual
who intends to, or may otherwise directly or indirectly benefit from, such information.
VII.
TERMINATION
A. The
Employee’s employment hereunder shall begin on the Effective Date and shall continue for the period set forth in Section
2 hereof unless renewed by mutual agreement or sooner terminated upon the first to occur of the following events:
1. The
death of the Employee;
2. One
year following the merger or consolidation in which either more than fifty percent of the voting power of the Corporation is transferred
or the Corporation is not the surviving entity, or sale or other disposition of all or substantially all the assets of the Corporation;
3. Termination
by the Board for Just Cause. Any of the following actions by the Employee shall constitute “Just Cause”:
a. Material
breach by the Employee of Section 1, Section 5, Section 6 or Section 8 of this Agreement;
b. Material
breach by the Employee of any provision of this Agreement other than Section 5, Section 6 or Section 8 which is not cured by the
Employee within thirty (30) days of notice thereof from the Corporation;
c. Any
action by the Employee to intentionally harm the Corporation or any action of gross negligence by the Employee; or
d. The
conviction of the Employee of a felony.
4. Termination
by the Employee for Just Cause. Any of the following actions or omissions by the Corporation shall constitute just cause, subject
to the notice and cure requirements below, provided that the Employee terminates employment with the Corporation within one year
following the initial existence of one or more of the following conditions, without the consent of the Employee:
a. Material
diminution of Base Salary;
b. Material
diminution of the Employee’s authority, duties or responsibilities; or
c. Material
breach by the Corporation of any provision of this Agreement which is not cured by the Corporation within thirty (30) days of
notice thereof from the Employee.
The
Employee must provide notice to the Corporation of the existence of the “just cause” condition not later than 90 days
of its initial existence and the Corporation shall have 30 days from the date of the Employee notice to cure the condition giving
rise to such notice.
B. Upon
termination by the Corporation pursuant to either subparagraph (i) or (iii) of paragraph (a) above or by Employee other than pursuant
to subparagraph (iv) of paragraph (a) above, the Employee (or her estate in the event of termination pursuant to subparagraph
(i)) shall be entitled to receive the Base Salary plus bonus accrued but unpaid as of the date of termination including any vacation
time accrued but not taken.
C. Upon
termination by the Corporation without Just Cause or pursuant to subparagraphs (i), (ii) or (iv) of paragraph (a) above, then
the term of the Agreement as set forth in Section 2 hereof shall be deemed to have been terminated as of such date and the Corporation
shall pay to the Employee (or her estate in the event of termination pursuant to subparagraph (i)), (A) Base Salary plus bonus
accrued but unpaid as of the date of termination, including any vacation time accrued but not taken, (B) severance equal to her
annual rate of Base Salary in effect as of the date of termination payable at said rate in accordance with the Corporation’s
payroll practices for a three month period (subject to set-off) (“Severance Pay”). Notwithstanding anything herein
to the contrary, the Employee shall not be entitled to the Severance Pay unless she executes and delivers to the Corporation a
general release of claims in such form as determined by the Corporation (the “Release”) and such Release becomes effective
and irrevocable within sixty (60) days following the date of termination or resignation. Any Severance Pay required under this
Section 7(c) shall commence on the first payroll date coincident or immediately following the sixtieth (60th) day following the
Employee’s date of termination. Notwithstanding anything herein to the contrary, each payment of Severance Pay shall be
deemed to be a separate payment within the meaning of Section 409A of the Code and the regulations thereunder. Health benefits
will also be maintained for Employee (or her dependents in the event of termination pursuant to subparagraph (i)) by the Corporation
during severance period. No unvested options shall vest beyond the termination date, except where previously noted in Section
3(b) or at the discretion of the Stock Option Plan Administrator. For purposes of payments under this Agreement that are subject
to (and not exempt from) Section 409A of the Code that are payable upon the Employee’s “termination of employment,”
such term shall instead mean “separation from service” within the meaning of Section 409A and the Treasury Regulations
promulgated thereunder.
D. Notwithstanding
anything to the contrary in this Agreement, if the Employee is determined by the Corporation to be a “specified employee”
within the meaning of Code Section 409A(a)(2)(B)(i) at the time of the Employee’s separation from service with the Corporation
and if any payment or benefit to which the Employee become entitled to under this Agreement would be considered deferred compensation
subject to interest and additional tax imposed pursuant to Section 409A(a) of the Code as a result of the application of Section 409A(a)(2)(B)(i)
of the Code, no such payment or benefit payable or provided to the Employee prior to the earlier of (i) the expiration of the
six (6) month period following the date of the Employee’s “separation from service” (as such term is defined
by Code Section 409A and the regulations promulgated thereunder), or (ii) the date of the Employee’s death, but only to
the extent such delayed commencement is otherwise required in order to avoid a prohibited distribution under Code Section 409A(a)(2).
The payments and benefits to which the Employee would otherwise be entitled during the first six (6) months following separation
from service shall be accumulated and paid or provided, as applicable, in a lump sum, on the date that is six (6) months and one
day following the Employee’s separation from service (or if such date does not fall on a business day of the Corporation,
the next following business day) and any remaining payments or benefits will be paid in accordance with the normal payment dates
specified for them herein.
VIII.
NON-DISPARAGEMENT
The
Employee agrees that during the Term, or any renewal or extension thereof, or at any time thereafter, the Employee will not make
any statements, comments or communications in any form, oral, written or electronic to any persons, including but not limited
to any “Media” (as defined below) or any customer, client, investor or supplier of the Corporation or any of its Affiliates,
which would constitute libel, slander or disparagement of the Corporation or any of its Affiliates, including, without limitation,
any such statements, comments or communications that criticize, ridicule or are derogatory to the Corporation or any of its Affiliates;
provided
,
however
, that the terms of this Section 8 shall not apply to communications between the Employee and,
as applicable, the Employee’s attorneys or other persons with whom communications would be subject to a claim of privilege
existing under common law, statute or rule of procedure. The Employee further agrees that the Employee will not in any way solicit
any such statements, comments or communications from others. For the purposes of this Agreement, the term “Media”
includes, without limitation, any news organization, station, publication, show, website, web log (blog), bulletin board, chat
room and/or program (past, present and/or future), whether published through the means of print, radio, television and/or the
Internet or otherwise, and any member, representative, agent and/or employee of the same.
IX.
NOTICES
Any
notice or other communication under this Agreement shall be in writing and shall be deemed to have been given: when delivered
personally against receipt therefor; one (1) day after being sent by Federal Express or similar overnight delivery; or three (3)
days after being mailed registered or certified mail, postage prepaid, return receipt requested, to either party at the address
set forth above, or to such other address as such party shall give by notice hereunder to the other party.
X.
SEVERABILITY
OF PROVISIONS
If
any provision of this Agreement shall be declared by a court of competent jurisdiction to be invalid, illegal or incapable of
being enforced in whole or in part, such provision shall be interpreted so as to remain enforceable to the maximum extent permissible
consistent with applicable law and the remaining conditions and provisions or portions thereof shall nevertheless remain in full
force and effect and enforceable to the extent they are valid, legal and enforceable, and no provision shall be deemed dependent
upon any other covenant or provision unless so expressed herein.
XI.
ENTIRE
AGREEMENT MODIFICATION
This
Agreement contains the entire agreement of the parties relating to the subject matter hereof, and the parties hereto have made
no agreements, representations or warranties relating to the subject matter of this Agreement which are not set forth herein.
No modification of this Agreement shall be valid unless made in writing and signed by the parties hereto.
XII.
BINDING
EFFECT
The
rights, benefits, duties and obligations under this Agreement shall inure to, and be binding upon, the Corporation, its successors
and assigns, and upon Employee and her legal representatives. This Agreement constitutes a personal service agreement, and the
performance of Employee’s obligations hereunder may not be transferred or assigned by Employee.
XIII.
NON-WAIVER
The
failure of either party to insist upon the strict performance of any of the terms, conditions and provisions of this Agreement
shall not be construed as a waiver or relinquishment of future compliance therewith, and said terms, conditions and provisions
shall remain in full force and effect. No waiver of any term or condition of this Agreement on the part of either party shall
be effective for any purpose whatsoever unless such waiver is in writing and signed by such party.
XIV.
GOVERNING
LAW
This
Agreement shall be governed by, and construed and interpreted in accordance with, the laws of the State of New Jersey without
regard to principles of conflict of laws.
XV.
CONSENT
TO JURISDICTION
The
parties hereto agree that any action or proceeding, however characterized, relating to or arising in connection with this Agreement
shall be maintained in the courts of the state of New Jersey and the parties hereby irrevocably submit to the exclusive jurisdiction
of any such court for the purposes of any action or proceeding and irrevocably agree to be bound by any judgment rendered by any
such court with respect to any such action or proceeding. The parties hereby waive any objection they may now or hereafter have
to the venue of any such action or proceeding in any such court and any claim that sets action or proceeding has been brought
in an inconvenient forum.
XVI.
HEADINGS
The
headings of paragraphs are inserted for convenience and shall not affect any interpretation of this Agreement.
IN
WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year above written.
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SOLIGENIX,
INC.
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By:
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/s/ Christopher
J. Schaber
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Christopher
J. Schaber, Ph.D.
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Chief Executive
Officer
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EMPLOYEE:
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By:
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/s/ Karen
Krumeich
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Karen
Krumeich
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10
EXHIBIT 99.1
Soligenix Appoints
Karen Krumeich, as
Chief Financial
Officer
Princeton, NJ
– June 20, 2016 –
Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company
focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today
that it has appointed Karen Krumeich, as its Senior Vice President and Chief Financial Officer. Ms. Krumeich has over 25 years
of diverse experience in the financial and strategic management of emerging growth life science companies. She has a proven track
record and expertise in corporate financial operations, equity financings, and business development, including partnerships, mergers
and acquisitions.
Most recently, Ms.
Krumeich served as a consultant providing finance, investor relations and business development services to the Company and other
healthcare companies. Previously, she worked as Vice President and Chief Financial Officer for several development-stage life
science companies, including Cerecor, Inc. and Mela Sciences, Inc. where she was responsible for equity financings, corporate
administrative functions and investor relations. In addition to these positions, Ms. Krumeich was a healthcare consultant partner
with Tatum, LLC, a national consulting firm, specializing in their life science practice. Prior to these positions, she held positions
of increasing responsibility with several healthcare companies, including Bristol-Myers Squibb Company where she was Director
of Health Systems and as Vice President of Finance for a national pharmacy provider. Ms. Krumeich began her career as a pharmacist
and transitioned into finance after successfully completing the CPA exam.
Ms. Krumeich earned
a BSc in Pharmacy from the University of Toledo, Ohio and completed her post graduate work in accounting and finance at Cleveland
State University while pursuing her career as a pharmacist.
“We are delighted
to welcome Karen to our team, as we leverage her extensive financial expertise in leading our strategic corporate programs,”
stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “As we continue to execute our growth
strategy, we are clearly building momentum and the talent we are attracting is an absolute reflection of our solid progress to
date. Karen’s unique experiences in both science and finance will be instrumental to us as we advance our multiple late-stage
development programs.”
Mr. Joseph Warusz,
who has served as Vice President, Finance and Acting Chief Financial Officer since February 2012, will be retiring from the Company
effective June 30, 2016. On behalf of the Company and its Board of Directors, we would like to thank Joe for his many contributions
during the past five years.
About Soligenix,
Inc.
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases
where there is an unmet medical need. Our BioTherapeutics business segment is developing SGX301 as a first-in-class photodynamic
therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, proprietary formulations of oral beclomethasone
17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation
including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201), and our novel innate defense regulator
technology dusquetide (SGX942) for the treatment of oral mucositis.
Our
Vaccines/BioDefense business segment includes active development programs for RiVax™, our ricin toxin vaccine candidate,
OrbeShield
®
, our GI acute radiation syndrome therapeutic candidate and SGX943, our melioidosis therapeutic candidate.
The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known
as ThermoVax
®
. Currently, this business segment is supported with up to $57 million in government grant and contract
funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development
Authority (BARDA).
For further information
regarding Soligenix, Inc., please visit the Company's website at
www.soligenix.com
.
This press release
may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance,
prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.
Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends,"
"potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks,
uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is
expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop, achieve
regulatory approval for or commercialize products based on its technologies, including dusquetide (SGX942), particularly in light
of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials
of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts
will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results
from research and development efforts, that it will be able to successfully obtain any further funding to support product development
and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements,
enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with
larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement
limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress
may not pass any legislation that would provide additional funding for the Project BioShield program. Positive results from the
Phase 2 study evaluating SGX942 does not ensure that the follow-on Phase 2/3 clinical study will be successful. These and other
risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited
to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any
forward-looking statements as a result of new information or future events.
Company Contact
:
Karen Krumeich
Chief Financial Officer
(609) 538-8200
|
www.soligenix.com
Soligenix, Inc.
29 Emmons Drive, Suite C-10
Princeton, NJ 08540
EXHIBIT 99.2
OTC QB: SNGX … Rising to the Challenges of Rare Disease Treatment
Forward - Looking Statements This presentation contains forward - looking statements . All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, prospective products and product candidates and their development, regulatory approvals, ability to commercialize our products and product candidates and attract collaborators, reimbursement for our product candidates, research and development costs, timing and likelihood of success, plans and objectives of management for future operations, our ability to obtain and maintain intellectual property protection for our product candidates and their development, competing therapies, and future results of current and anticipated products and product candidates, are forward - looking statements . These statements involve known and unknown risks, uncertainties, and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward - looking statements, many of which are disclosed in detail in our reports and other documents filed with the Securities and Exchange Commission . Because forward - looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward - looking statements as predictions of future events . The events and circumstances reflected in our forward - looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward - looking statements . Except as required by applicable law, we do not plan to publically update or revise any forward - looking statements contained herein, whether as a result of any new information, future events, changed circumstances, or otherwise . Certain information contained in this presentation and statements made orally during this presentation relate to or are based on studies, publications, surveys and other data obtained from third - party sources . In addition, no independent source has evaluated the reasonableness or accuracy of Soligenix, Inc . internal estimates and no reliance should be made on any information or statements made in this presentation relating to or based on such internal estimates . 2
Company Highlights 3 » Diversified product portfolio in advanced development , targeting rare disease indications in inflammation, oncology and biodefense with $200M+ markets worldwide o Phase 3 clinical program for the treatment of cutaneous T - cell l ymphoma ( SGX301) - Orphan drug and fast track designations - Pivotal study actively enrolling patients with results second half 2017 o Phase 3 clinical program for the treatment of pediatric Crohn’s disease ( SGX203 ) - Orphan drug and fast track designations - Pivotal study to begin first half 2017 with results second half 2018 o Phase 2 clinical program for the treatment of oral mucositis in head & neck cancer ( SGX942 ) - Fast track designation - Study enrollment complete with positive preliminary results » Five development candidates supported in whole or in part by government funding » Robust news flow potential over next 12 - 24 months across eight development programs » Collaborations established with biotech, academia and government agencies » Up to $ 58M in non - dilutive contract/grant funding provided by the government, including o NIAID contract award of up to $ 24.7M supporting the development of RiVax ™ for pre - exposure to ricin toxin o BARDA and NIAID contract awards of up to $26.3M and $ 6.7M, respectively, supporting the development of OrbeShield ® for gastrointestinal acute radiation syndrome
4 Rare Disease Pipeline Product Candidates Preclinical Phase 1 Phase 2 Phase 3 Market SGX301 Cutaneous T - Cell Lymphoma (CTCL) SGX203 Pediatric Crohn’s Disease** SGX942 Oral Mucositis in Head & Neck Cancer** SGX201 Radiation Enteritis** BioTherapeutics Vaccines / BioDefense ** Product Candidates (FDA Animal Rule) Proof - of - Concept Animal Phase 1 Phase 2/3 Market ThermoVax ® ( TVax ) Heat Stabilization Technology for Vaccines RiVax TM + TVax – Heat Stable Vaccine Ricin Toxin Pre - Exposure OrbeShield ® – Therapeutic GI Acute Radiation Syndrome (GI ARS) SGX943 – Therapeutic Melioidosis Positive Ph. 2 data *Anticipated event and timing * *Potential value drivers dependent on continued government funding and/or other funding sources Ph . 3 data 2H 2018* Positive Phase 1/2 data Denotes funding in whole or in part by NIH, BARDA and/or FDA NIAID Contract Award of up to $24.7M BARDA and NIAID Contract Awards of up to $33M collectively Ebola Vaccine Collaboration: data 2H 2016* NIH Small Business Grant Award of $300,000 Ph. 3 data 2H 2017* ORPHAN & FAST TRACK DESIGNATIONS ORPHAN & FAST TRACK DESIGNATIONS FAST TRACK DESIGNATION FAST TRACK DESIGNATION FAST TRACK ORPHAN DESIGNATION VACCINE PLATFORM ORPHAN & FAST TRACK DESIGNATION
1 H : Ph. 1/2 human safety data 2H : Ph. 1/2 human safety study start 5 Multiple Potential Value Drivers SGX203* ThermoVax ® * 2016 SGX301 2017 RiVax TM * OrbeShield ® * 2018 1H : Ph. 3 start Pediatric Crohn’s SGX942* Ph. 2 long - term data Oral Mucositis * Potential value drivers dependent on continued government funding and/or other funding sources Preclinical animal data EU orphan drug designation 1H: Ph. 3 complete CTCL enrollment 1H : Preclinical animal data FDA clearance Ph. 3 protocol Ebola vaccine feasibility data 1H: NDA submission CTCL 1H: Ph. 2b/3 start Oral Mucositis 2H : Preclinical animal data 2H: Ph. 2b/3 data Oral Mucositis NIAID contract option award 2H: Ph. 3 data Pediatric Crohn’s 1H : Ricin vaccine animal data 1 H : Ph. 1/2 human safety data 2H: Ph. 3 data CTCL
Significant WW Market Potential $300 0 50 100 150 200 $ Millions 250 300 $250 400 350 OrbeShield ® GI Acute Radiation Syndrome SGX301 Cutaneous T - Cell Lymphoma Assumptions (1) Oral Mucositis in Head and Neck Cancer 90,000 Patients US 90,000 Patients EU Cutaneous T - Cell Lymphoma 20,000 Patients US 20,000 Patients EU Pediatric Crohn’s Disease 80,000 Patients US 80,000 Patients EU Acute Radiation Enteritis in Colorectal Cancer 50,000 Patients US 50,000 Patients EU RiVax TM Ricin Vaccine Assumes 3 year procurement order of $200 million OrbeShield ® GI ARS Assumes 3 year procurement order of $450 million SGX201 Acute Radiation Enteritis $200 6 RiVax TM Ricin Vaccine $200 $450 450 500 $500+ SGX942 Oral Mucositis (1) Supporting data on file SGX203 Pediatric Crohn’s Disease
Experienced Management and Board of Directors 7 Christopher J. Schaber , PhD President & CEO • 26 years of experience • Discovery Laboratories (COO) • Acute Therapeutics (Co - Founder) • Ohmeda Pharmaceuticals • The Liposome Company • Wyeth Ayerst Oreola Donini, PhD Chief Scientific Officer • 15 years of experience • Inimex Pharmaceuticals • ESSA Pharma , Inc • Kinetek Pharmaceuticals Karen Krumeich Chief Financial Officer Rasappa Arumugham, PhD VP, Biopharm Development • 26 years of experience • Merck • Pfizer • Wyeth Keith Brownlie, CPA • 35 years of experience • Ernst & Young Gregg Lapointe, CPA, MBA • 20 years of experience • Cerium Pharmaceuticals (CEO) • Sigma - Tau Pharmaceuticals • AstenJohnson • Price Waterhouse Coopers Robert Rubin, MD • 36 years of experience • The Lewin Group • Georgetown School of Medicine • Former Assistant Surgeon General of the United States Jerome Zeldis, MD, PhD • 33 years of experience • Celgene Corporation (CMO) • Sandoz • Janssen Research Institute Marco Brughera, DVM • 30 years of experience • Sigma - Tau SpA (Global Head, Rare Disease Franchise) • Pfizer • Pharmacia Richard Straube, MD Chief Medical Officer • 30 years of experience • Stealth Peptides Inc. • INO Therapeutics • Ohmeda Pharmaceuticals • Centocor • 25 years of experience • Cerecor • Mela Sciences • Bristol - Myers Squibb
Targeted Approach to Treating Oncology & Inflammation BioTherapeutics 8
BioTherapeutics Business Segment Soligenix BioTherapeutics Segment Oncology and Oncology Supportive Care SGX301 (Synthetic Hypericin ) Cutaneous T - Cell Lymphoma SGX942 ( Dusquetide ) Oral Mucositis in Head and Neck Cancer SGX201 (Beclomethasone 17,21 - Dipropionate) Acute Radiation Enteritis Autoimmune (GI Inflammation) SGX203 (Beclomethasone 17,21 - Dipropionate) Pediatric Crohn’s Disease Commercial targets – unmet medical needs in oncology and inflammation 9
10 Cutaneous T - Cell Lymphoma – Disease Overview » Cutaneous T - cell lymphoma (CTCL) o R are class of Non - Hodgkin's Lymphoma (NHL) o Malignant T - cells migrate to the skin o Cancer forms patches or lesions » CTCL affects over 40 , 000 NHL patients worldwide ; currently no cure » Two main subtypes of CTCL o Mycosis fungoides (MF) - Early - stage (most common), 88% 5 - year survival o Sézary syndrome (SS) - Advanced - stage, 24% 5 - year survival » No approved front - line therapy for early stage (I - IIA) CTCL (~95% of CTCL patients); unmet medical need Atypical T - cells in dermis
11 SGX301 – Synthetic Hypericin SGX301 is a first - in - class, topical drug applied to CTCL skin lesions followed by activation with safe, visible, fluorescent light to kill malignant T - cells » Affects over 40,000 patients annually worldwide » No approved front - line therapy for early stage (I - IIA) CTCL (~95% of CTCL patients); unmet medical need » Most common (unapproved) therapy used for early - stage disease is psoralen given with ultraviolet A (UVA) light, referred to as PUVA » PUVA contains Black Box warning for potential malignancies (melanoma) due to psoralen being mutagenic and light source (UVA) being carcinogenic Market Opportunity Development Status » FDA Orphan Drug and Fast Track designations granted » Phase 1 study demonstrated safety and tolerability » Phase 2 double - blind, placebo - controlled, multi - center study d emonstrated statistically significant (p < 0.04) response » Pivotal Phase 3 trial actively enrolling ~120 subjects » Results expected 2H 2017
CTCL Patch Pre - Therapy Hypericin Therapy Using Visible Light CTCL Patch Post - Therapy SGX301 – Phase 2 Response Rate 12 Summary of CTCL Lesion Responses to Synthetic Hypericin Ointment Following Six Weeks of Treatment Responders/Total Percent Responders Hypericin Responders 7/12 58.3% Placebo Responder 1/12 8.3% Note : No serious adverse events other than mild phototoxicity at treated site Data Source: Journal American Academy Dermatology, Vol 63, Number 6, 2010
13 Oral Mucositis – Disease Overview » Oral mucositis (OM) o Multi - factorial disease linked to a dysregulation of the innate immune system » OM affects over 180,000 head and neck (H&N) cancer patients worldwide » Debilitating side effect of cancer chemotherapy and / or radiotherapy o Triggering inflammatory cascade o Massive ulceration of the mouth, tongue, soft palate and oropharynx » Results in: o Severe pain causing an inability to eat or even drink o Reduced cancer treatment tolerance o Significant increases in resource use and cost of care » No approved drug for OM in head and neck cancer; unmet medical need Ref: S. Sonis 2004 Inflammation causes worsening damage Secondary infection
14 SGX942 – Innate Defense Regulator SGX942 (dusquetide) is a first - in - class, injectable drug, called an Innate Defense Regulator (IDR), that modulates the body’s innate immune system to reduce inflammation » OM affects over 180,000 H&N cancer patients worldwide » No approved drug for OM in H&N cancer; unmet medical need » Only approved drug for OM is palifermin in transplantation; contra - indicated for patients with solid tumors like H&N cancer » Exclusive commercial collaboration with SciClone in China Market Opportunity Development Status » FDA Fast Track designation granted » Robust data demonstrating effectiveness in multiple animal models of bacterial infection and mucosal damage, including OM » Phase 1 study in 84 healthy volunteers demonstrated safety » Phase 2 double - blind, dose - ranging, placebo - controlled proof - of - concept study in 111 H&N cancer patients with OM o Positive data: 50% reduction in duration of severe OM o Identified best dose, endpoint and patient population for follow - on pivotal trial(s) » Long term follow - up ongoing with safety results 4Q 2016 » Phase 2b/3 study clearance and initiation targeted 1H 2017
SGX942 – Preliminary Oral Mucositis Results 15 » Phase 2 exploratory clinical study o Enrolled H&N cancer patients receiving at least 55 Gy radiation and either weekly (30 - 40mg/m 2 ) or every 3 rd week (80 - 100mg/m 2 ) chemotherapy o Dose escalating: Placebo, 1.5, 3.0 and 6.0 mg/kg administered twice weekly o Key efficacy endpoints: incidence and/or duration of severe OM » Achieved all study objectives x Assessed safety in a sick patient population ▪ SGX942 safe and well tolerated x Determined that preclinical biology translates to human setting ▪ Decreased duration, decreased infection rate and potential tumor effect all consistent with preclinical biology x Identified most appropriate clinical endpoint ▪ Duration of severe OM x Determined best dose of SGX942 ▪ 1.5 mg/kg x Determined clinical effect size of SGX942 ▪ 50% decrease in duration; consistent with 46 - 53% reduction in animal models x Characterized patient population ▪ Strongest SGX942 response in patients receiving most aggressive chemotherapy
SGX942 – Preliminary Oral Mucositis Results 16 » Clinically Meaningful Results o 50% decrease in duration of severe OM overall with 67% decrease in patients receiving aggressive chemotherapy (80 - 100 mg/m 2 ) ▪ Consistent with decreased incidence and delay in mean onset of severe OM o Increased incidence in tumor “complete response” at 1 month follow - up visit (47% in placebo vs 63% in SGX942) o Reduced infection rates o Results consistent with preclinical data 0 20 40 60 Duration of Severe Oral Mucositis D u r a t i o n W H O 3 M e d i a n 9 5 % C I ( D a y s ) p=0.099 Placebo N=38 SGX942 1.5mg/kg N=36 18 days 9 days 0 20 40 60 Duration of Severe Oral Mucositis Aggressive Chemotherapy D u r a t i o n W H O 3 M e d i a n 9 5 % C I ( D a y s ) p=0.040 Placebo N=22 SGX942 1.5mg/kg N=24 30 days 10 days
17 Pediatric Crohn’s Disease – Disease Overview » Pediatric Crohn’s disease o Chronic inflammatory disorder of the gastrointestinal (GI) tract o Diarrhea, rectal bleeding and abdominal pain » Resulting in growth failure, malnutrition, pubertal delay and bone demineralization » Over 160,000 children/adolescents with Crohn’s disease worldwide » Location of disease o Adult predominantly lower GI tract o 50% of children have involvement in the upper GI tract » No approved drug for mild - to - moderate pediatric Crohn’s disease in the US; unmet medical need Normal mucosa under endoscopy
18 SGX203 – Beclomethasone Dipropionate SGX203 is a proprietary oral formulation of immediate and delayed release beclomethasone 17,21 - dipropionate (BDP) tablets to treat GI inflammation with less toxicity than the current standard systemic steroid therapy » 160,000 children/adolescents with Crohn’s disease worldwide – 50% have inflammation of upper GI » No approved drug for mild - to - moderate; unmet medical need » Currently unapproved systemic steroids used front - line cause adrenal suppression, growth impairment, bone demineralization » Oral BDP delivers high GI steroid effects with minimal (~35%) systemic side effects » Remicade and Humira only approved products in Pediatric Crohn’s in US – generally used after steroids fail » Both contain Black Box warning for increased risk of infection and potential malignancy (T cell lymphoma) Market Opportunity Development Status » FDA Orphan Drug and Fast Track designations granted » Active ingredient BDP FDA approved for over 40 years in other delivery forms (e.g., aerosol) to treat diseases such as asthma » ~350 subjects treated with oral BDP to date in multiple trials » Pivotal Phase 3 adaptive trial in ~150 subjects targeted 1H 2017 » Results expected 2H 2018
Vaccine/BioDefense 19 Addressing Critical Concerns for Industry and Government
20 Soligenix Vaccine / BioDefense Segment* ThermoVax ® Vaccine Heat Stabilization Platform Infectious Disease: HPV and Ebola Vaccines BioDefense : RiVax TM Ricin Vaccine OrbeShield ® (Oral BDP Therapeutic ) Gastrointestinal Acute Radiation Syndrome (GI ARS) SGX943 ( Dusquetide Therapeutic) Melioidosis Vaccine/BioDefense Business Segment * Funded by Government
ThermoVax ® – Vaccine Thermostability Platform 21 ThermoVax ® is a proprietary freeze - drying process that enables vaccines to be stored without refrigeration Demonstrated retained efficacy up to 1 year at 40 ⁰ C (104 ⁰ F) Market Opportunity Development Status » WHO reports about 50% of all vaccine doses globally are wasted due to excursions from required cold chain temperature ranges » DHHS reports vulnerabilities in pediatric vaccine programs due to undetected cold chain variations » Elimination of cold chain costs would significantly increase profit potential of vaccines, especially in third - world/emerging markets » Continue development under $24.7M NIAID contract for RiVax » Conduct POC feasibility studies with other adjuvanted vaccines including secondary adjuvants and/or multivalent combinations » Initiated feasibility assessment of Ebola vaccine development Positive results: o Ricin vaccine o Anthrax vaccine o HPV vaccine 0 7 30 90 180270360 0 50 100 Stability Day % I m m u n o g e n i c i t y 40 o C ThermoVax 40 o C Original
22 Heat - stable ricin vaccine provided 100% protection in a non - human primate aerosol challenge model (right) Demonstrated safety in Phase 1 studies Market Opportunity Development Status » Ricin toxin vaccine of rising interest to US due to recent terrorist threats and ease of castor bean procurement and production » Government has placed priority on development activities » Potential to be first approved ricin toxin vaccine » FDA Orphan Drug designation granted » Development agreement with Emergent BioSolutions for manufacturing » NIAID contract award of up to $24.7M over 6 years RiVax TM – Ricin Toxin Vaccine Days Post-Intoxication % S u r v i v a l 0 5 10 15 0 25 50 75 100 Sham (N=6) Vaccine (N=12) p<0.0001 *Late death not directly attributed to ricin intoxication
23 Two - tablet BDP system also efficacious in animal models of gastrointestinal acute radiation syndrome (GI ARS) Preliminary proof of concept data in canine model of GI ARS (right) Market Opportunity Development Status » Oral BDP is a "re - purposed" drug, of particular importance to BARDA » Category A countermeasures against radiation exposure of interest to US / World governments » Over $600M spent to date on therapeutics against radiation injury » FDA Orphan Drug and Fast Track designations granted » BARDA contract award of up to $26.3M over 5 years » NIAID contract award of up to $6.7M over 3 years OrbeShield ® for GI Acute Radiation Syndrome 0 5 10 15 0 25 50 75 100 Study Day % S u r v i v a l p<0.05 Placebo (N=4) BDP (N=6)
Investment Highlights 24 » Diversified product portfolio in advanced development , targeting rare disease indications in inflammation, oncology and biodefense with $200M+ markets worldwide o Phase 3 clinical program for the treatment of cutaneous T - cell l ymphoma ( SGX301) - Orphan drug and fast track designations - Pivotal study actively enrolling patients with results second half 2017 o Phase 3 clinical program for the treatment of pediatric Crohn’s disease ( SGX203 ) - Orphan drug and fast track designations - Pivotal study to begin first half 2017 with results second half 2018 o Phase 2 clinical program for the treatment of oral mucositis in head & neck cancer ( SGX942 ) - Fast track designation - Study enrollment complete with positive preliminary results » Five development candidates supported in whole or in part by government funding » Robust news flow potential over next 12 - 24 months across eight development programs » Collaborations established with biotech, academia and government agencies » Up to $ 58M in non - dilutive contract/grant funding provided by the government, including o NIAID contract award of up to $ 24.7M supporting the development of RiVax ™ for pre - exposure to ricin toxin o BARDA and NIAID contract awards of up to $26.3M and $ 6.7M, respectively, supporting the development of OrbeShield ® for gastrointestinal acute radiation syndrome
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