Oncotelic Therapeutics, Inc 8-K, filed Mar 23, 2020
Oncotelic Therapeutics, Inc. (OTLC)
About this 8-K
Oncotelic Therapeutics, Inc filed this 8-K on March 23, 2020, reporting on events of March 18, 2020.
Items reported
- Item 1.01: Entered into a material agreement
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
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)
March 18, 2020
MATEON THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 000-21990 | 13-3679168 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
29397 Agoura Road Suite 107
Agoura Hills, CA 91301
(Address of principal executive offices and Zip Code)
Registrant’s telephone number, including area code
(650) 635-7000
(Former name or former address, if changed since last report.)
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)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of class | Trading Symbols | Name of each exchange on which registered | ||
| N/A |
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 [ ]
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 1.01 Entry into a Material Definitive Agreement.
Research Service Agreement between Golden Mountain Partners LLC (GMP) and Mateon Therapeutics Inc./Oncotelic Inc. (“Mateon Entities”).
When COVID-19 emerged in China, Mateon and GMP contemplated a collaboration to develop drug candidates for COVID-19. Oncotelic and GMP entered into a research and services agreement (the “Agreement”) on February 3, 2020 memorializing their collaborative efforts to develop and test COVID-19 antisense therapeutics.
On March 18, 2020, Mateon reported the anti-viral activity of OT-101 – its lead drug candidate currently in phase 3 testing in pancreatic cancer and glioblastoma. In an in vitro antiviral testing performed by an independent laboratory, OT-101 has an 50% effective concentration (EC50) of 7.6 µg/mL and is not toxic at the highest dose of 1000 µg/mL giving a safety index (SI) value of >130, which is considered highly active. On March 23, 2020, Mateon, Oncotelic, Inc., and GMP entered into a supplement to the Agreement (the “Supplement”) to confirm the inclusion of OT-101 within the scope of the Agreement, pending positive confirmatory testing against COVID-19.
In consideration for the financial support provided by GMP for the research, pursuant to the terms of the Agreement (as amended by the Supplement) GMP is entitled to obtain certain exclusive rights to the use of the Product in the COVID Field on a global basis, and an economic interest in the use of the Product in the COVID Field including 50/50 profit sharing.
As described in the Supplement, the Mateon Entities intend to license or assign intellectual property rights, including the 2020 Patent Application and any other intellectual property rights owned or controlled by the Mateon Entities relating to the Product, OXi4503 and CA4P, to a joint venture company to be established jointly between Oncotelic and GMP (or its designee), as well as providing management services and other expertise to the joint venture company; GMP intends that it (or its designee, as the case may be) shall provide funding to the joint venture company to support its development and commercial activities in the joint venture company’s territories; in each case, on terms to be agreed by the parties; and GMP shall be entitled to use its governmental relations and local expertise in Greater China to assist with coordinating the research, development and commercialization of (i) the Products in the COVID Field, (ii) the Products in the OT101 Oncology Field, (iii) OXi4503; and (iv) CA4P, in each case in Greater China.
The joint venture company is intended to be owned 50% by Oncotelic and 50% by GMP (or its designee), and its principal activities shall be to research, develop, bring to market and commercialize: (i) the Products in the COVID Field on a global basis, (ii) the Products in the OT101 Oncology Field in the Licensed Territory, (iii) OXi4503 in the Licensed Territory; and (iv) CA4P in the Licensed Territory. Upon completion of due diligence by one another and subject to GMP’s satisfactory due diligence review, the parties intend to enter into written definitive agreements for the Joint Venture Transaction within the Exclusivity Period of 90 days.
| -2- |
Item 8.01 Other Events
Press release
On March 18, 2020, Mateon reported the anti-viral activity of OT-101 – its lead drug candidate currently in phase 3 testing in pancreatic cancer and glioblastoma, in an in vitro antiviral testing performed by an independent laboratory, OT-101 has an 50% effective concentration (EC50) of 7.6 µg/mL and is not toxic at the highest dose of 1000 µg/mL giving a safety index (SI) value of >130, which is considered highly active.
Provisional Patent Filing
On March 18, 2020 and March 20, 2020, Oncotelic, Inc. (“Oncotelic”), a wholly-owned subsidiary of Mateon Therapeutics, Inc. (“Mateon” or the “Company”), filed three provisional patent applications on the method of use and composition of matter for the treatment of COVID-19. The filings represent the culmination of internal research programs, including efforts with our external partner, and position our antisense platforms for further development for the treatment of epidemics and pandemics.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | Incorporation by reference | ||
| 10.1 | Research and Services Agreement | Filed herewith. | ||
| 10.2 | Supplement Research and Services Agreement | Filed herewith. | ||
| 99.1 | 3-18-2020 Press release | Filed herewith. |
| -3- |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Mateon Therapeutics, Inc. | ||
| Date: March 23, 2020 | /s/ Vuong Trieu | |
| By: | Vuong Trieu | |
| Chief Executive Officer | ||
| -4- |
Exhibit 10.1
RESEARCH AND SERVICES AGREEMENT
THIS RESEARCH AND SERVICES AGREEMENT (together with the attached Statement of Work, Deliverables and Payment, the “Agreement”) is made as of February 3, 2020 (the “Effective Date”) by and between ONOTELIC, INC., a Delaware corporation (“Oncotelic”) and GOLDEN MOUNTAIN PARTNERS, LLC, a California limited liability company (“GMP”).
1. Background and Agreement Structure. The parties hereby enter into a contractual partnership with respect to certain research of the “coronavirus.” The parties intend for any research results to be “gifted” to the government of The People’s Republic of China. (The two foregoing sentences express the parties’ “Purpose” in entering this Agreement.) Oncotelic will perform all research under this Agreement, as set forth herein (collectively, the “Services”). GMP agrees to pay Oncotelic for its Services.
This Agreement contains the general terms and conditions under which Oncotelic will perform the Services and GMP will compensate or reimburse Oncotelic for such Services. The attached Statement of Work, Deliverables and Payment (“SOW”) sets forth the specifics of the Services, deliverables to be delivered by Oncotelic and the milestones upon which compensation and/or reimbursement will be made to Oncotelic by GMP.
2. Services.
| 2.1 | Provision of Services. Oncotelic agrees to provide all Services identified in the SOW: (a) promptly, and (b) at such times and at such places as mutually agreed upon by GMP and Oncotelic with Oncotelic agreeing to make every effort to comply with timeframes reasonably set forth on the SOW. |
| 2.2 | No Subcontracting. At no time shall Oncotelic subcontract the performance of any of the Services, except to an Affiliate of Oncotelic. “Affiliate” means, with respect to each party to this Agreement, any corporation, company, partnership, joint venture and/or firm which controls, is controlled by or is under common control with that party. As used in this Section 2.2, “control” means (i) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors (or such lesser percentage that is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction), and (ii) in the case of non-corporate entities, the direct or indirect power to manage, direct or cause the direction of the management and policies of the non-corporate entity or the power to elect at least fifty percent (50%) of the members of the governing body of such non-corporate entity. |
3. Representations and Warranties by Oncotelic. Oncotelic makes the following representations and warranties, and agrees to notify GMP in writing immediately upon any future breach of these representations and warranties:
| 3.1 | Organization of Oncotelic. Oncotelic is and will remain a corporation organized, validly existing and in good standing under the laws of its jurisdiction of incorporation. |
| 3.2 | Enforceability of this Agreement. The execution and delivery of this Agreement has been authorized by all requisite corporate action. This Agreement is and will remain a valid and binding obligation of Oncotelic, enforceable in accordance with its terms, subject to laws of general application relating to bankruptcy, insolvency and the relief of debtors. | |
| 3.3 | Absence of Other Contractual Restrictions. Oncotelic is under no contractual or other obligation or restriction that is inconsistent with Oncotelic’s execution or performance of this Agreement. Oncotelic will not enter into any agreement, either written or oral, that would conflict with Oncotelic’s responsibilities under this Agreement. | |
| 3.4 | Conflicts with Rights of Third Parties. To the best of Oncotelic’s knowledge, the provision of Services under this Agreement will not violate any patent, trade secret or other proprietary or intellectual property right of any third party. |
4. Compensation. As full consideration for the Services rendered under the SOW, GMP will automatically pay Oncotelic in accordance with the terms in the SOW and Oncotelic shall not be required to do anything further in order to earn such payments. All payments shall be made in US Dollars.
5. Revenue Sharing. Although the parties intend and agree that this Agreement is not intended for profit or to make or generate a profit to or for either party, in the event revenues are generated from the sale, distribution or other assignment of rights (collectively, “Sales”) as a result of the Purpose or Services hereunder, Oncotelic and Golden Mountain shall each be entitled to fifty percent (50%) of the net income from such Sales. Specific accounting with respect to such revenue sharing rights of the parties shall be further negotiated and agreed to by the parties in good faith.
6. Proprietary Rights.
| 6.1 | Materials. All documentation, information, and biological, chemical and other materials controlled and furnished by Oncotelic in performance of the Services (collectively, the “Materials”) and all associated intellectual property rights will remain the exclusive property of Oncotelic, and no transfer or license of rights therein to any party is hereby granted or implied. It is understood by the parties that Oncotelic will use Materials only as necessary to perform the Services. | |
| 6.2 | Deliverables. Discoveries, results, ideas, designs, processes, methods, techniques, compounds, formulations, products, information, data, documentation, reports, research, creations and other deliverables that are created or generated by Oncotelic in the performance of the Services are collectively referred to herein as the “Deliverables.” Oncotelic and Golden Mountain shall have joint ownership of the Deliverables. |
Oncotelic will retain full ownership rights in and to all inventions, processes, know-how, templates, programs and other materials, technologies and intellectual property rights developed or obtained or licensed from third parties by Oncotelic and its Affiliates prior to or independent of the performance of its obligations under this Agreement (“Oncotelic Property”), and any improvements on enhancements thereto that are generated during the course of performing the Services and no transfer of rights or license therein is hereby granted or implied to any party, including, but not limited to GMP.
7. Confidentiality Obligations.
| 7.1 | Definitions. |
“Agents” means, with respect to either party, its officers, employees and agents who have a need to know to further the Purpose, and such party’s attorneys. For avoidance of doubt, “Agents” does not include Directors of the party.
“Confidential Information” includes, without limitation, all written, oral or other information and materials concerning the party disclosing such information (the “Disclosing Party” and/or its business, clients, partners, joint ventures and Affiliates, whether prepared by Disclosing Party, its Agents or otherwise, which shall be (or shall have been) provided or disclosed by or on behalf of Disclosing Party to the other party (each, a “Receiving Party”) or its Agents in the course of its discussions with Receiving Party regarding this Agreement or the Purpose (or obtained by Receiving Party or its Agents through inspection or observation of the properties, facilities or operations of Disclosing Party), including but not limited to activities undertaken by such party, technical, scientific, business, financial and other information, data and materials relating to drug applications, patent applications, products and proposed products, ideas, inventions, techniques, algorithms, programs (whether in source code or object code form), hardware, designs, schematics, drawings, trade secrets, know-how, processes, proposed processes, formulations, manufacturing technology, contracts, clinical and pre-clinical data and dossiers, business relationships, suppliers, customers, employees, investors, marketing strategies, distribution strategies and any and all other similar information, data and materials(together with all communications, data, reports, analyses, compilations, studies, interpretations, records, notes, or other materials or information prepared by Receiving Party or any of its Agents or activities undertaken by Receiving Party or any of its Agents, that contain or otherwise reflect or are based upon, in whole or in part, any Confidential Information of Disclosing Party or that reflect the Services or Purpose.
Confidential Information includes the circumstances, facts and activities relating to, regarding and/or surrounding and arising out of this Agreement, the Purpose and the Services.
Confidential Information shall also include the existence or terms of this Agreement, the existence or substance of communications between the parties relating to this Agreement, the Purpose and/or the Services, and any matters relating to the foregoing. As used herein, each of Disclosing Party and Receiving Party shall include its Affiliates. In addition, for the avoidance of doubt, this Agreement shall apply to and cover the Confidential Information of Disclosing Party’s Affiliates.
| 7.2 | Non-Disclosure. |
(a) Receiving Party shall: (a) hold and maintain in strict confidence all Confidential Information (including Confidential Information of the Disclosing Party), and shall use the same degree of care that it uses to protect its own confidential and proprietary information of similar nature and importance (but in no event less than reasonable care) to protect the confidentiality and avoid the unauthorized use, disclosure, publication or dissemination of Confidential Information (including Confidential Information of the Disclosing Party); and (b) not disclose any Confidential Information and Confidential Information of Disclosing Party to any person other than to those Agents of Receiving Party who (i) strictly need to know the Confidential Information or Confidential Information of the Disclosing Party in furtherance of, or to accomplish the Purpose; (ii) shall be advised by Receiving Party of the terms of this Agreement; and (iii) are bound by restrictions regarding disclosure and use of such Confidential Information comparable to and no less restrictive than those set forth herein. Receiving Party shall be responsible for the breach of any of the terms hereof by any of its Agents.
Notwithstanding the foregoing, Oncotelic acknowledges that GMP must have the right to disclose Confidential Information to government officials or agencies of The People’s Republic of China and Oncotelic hereby agrees that GMP has the right hereunder to disclose Confidential Information to such government officials or agencies of The People’s Republic of China as GMP, in its sole discretion, deems is in the parties’ best interest or necessary to disclose in furtherance of or to accomplish the Purpose.
Except as otherwise permitted in this Section 7.2, neither party shall directly or indirectly by any means or manner whatsoever publicize, disclose, urge, encourage, cooperate in, cause or permit the disclosure to any person or entity other than an Agent of such party who strictly needs to know such information in furtherance of or to accomplish the Purpose: (A) the circumstances, facts or activities relating to, regarding and/or surrounding or arising out of this Agreement, the Services or the Purpose, or (B) the existence or terms of this Agreement, the Services or the Purpose, the existence or substance of discussions between the parties relating to this Agreement, the Services or the Purpose, and any matters relating to the foregoing. Except as otherwise permitted in this Section 7 and as reserved to GMP, in response to any inquiry regarding a party’s knowledge of the Purpose or the Services, such party shall state only that it has no comment.
(b) Receiving Party and its Agents shall not (a) copy, duplicate, extract or otherwise reproduce by any means, all or any part of the Confidential Information or Confidential Information of the Disclosing Party (except as necessary to accomplish the Purpose), nor (b) decompile, disassemble, reverse engineer, or determine the physical or chemical properties of any Confidential Information of Disclosing Party or any portion thereof, or determine or attempt to determine any source code, algorithms, methods or techniques embodied in any Confidential Information of Disclosing Party or any portion thereof. Upon termination of this Agreement (or upon request by either party hereto), Receiving Party shall (c) cease using the Confidential Information or Confidential Information of Disclosing Party for any purpose (including the Purpose) and (d) return to Disclosing Party (or destroy at Disclosing Party’s sole election) all materials in any form containing or reflecting any Confidential Information of Disclosing Party in the possession or control of Receiving Party or any of its Agents. In the case of Confidential Information stored in electronic form, the Receiving Party shall ensure that such Confidential Information is permanently erased. Notwithstanding the foregoing, the Receiving Party may retain one copy of Confidential Information to the extent required to be maintained pursuant to applicable law or to satisfy the Receiving Party’s record retention obligations. Furthermore, Confidential Information that is electronically stored may be retained on back-up servers if it is not intentionally made available to any person, and is deleted in accordance with the Receiving Party’s normal policies with respect to the retention of electronic records. Notwithstanding the return or destruction of any Confidential Information, or documents or material containing or reflecting any Confidential Information, the parties will continue to be bound by their obligations of confidentiality and other obligations hereunder in accordance with this Section 7.
7.3. In the event that Receiving Party is requested or required (by subpoena, civil investigative demand or other process) to disclose any Confidential Information of Disclosing Party, Receiving Party shall provide Disclosing Party with prompt written notice of any such request or requirement. Should Receiving Party be compelled by such legal process to disclose Confidential Information, Receiving Party may disclose only that portion of the Confidential Information which it is compelled to disclose. Receiving Party shall cooperate with Disclosing Party, at the Disclosing Party’s sole cost and expense, in any attempt that Disclosing Party may make to obtain an appropriate protective order or other reliable assurance that confidential treatment shall be accorded to the Confidential Information.
8. Exclusive Dealing.
8.1. GMP shall have the exclusive right to disclose, negotiate with and discuss commercialization of the Deliverables, or any drug or therapeutic arising out of the Deliverables, with the government of The People’s Republic of China, or with any other interested third parties.
8.2. Neither party shall have the right to offer for sell, sell, distribute, offer to distribute, manufacture, or offer to manufacture any Deliverable or any drug or therapeutic arising out of the Deliverables, with any third party, or to assist any third party to do any of the foregoing, without mutual consent and participation of the other party.
9. Expiration and Termination.
| 9.1 | Expiration. This Agreement will expire on the later of (a) one (1) year from the Effective Date or (b) the completion of all Services under the last SOW executed by the parties prior to the first anniversary of the Effective Date. Unless earlier terminated in accordance with Section 8.2, below, this Agreement will renew automatically for successive one (1) year terms commencing upon the expiration of the initial term. | |
| 9.2 | Effect of Termination or Expiration. Upon termination or expiration of this Agreement, neither Oncotelic nor GMP will have any further obligations under this Agreement, except that: | |
| (a) Each party will promptly return to the other party all copies of all Confidential Information of the other party in such party’s possession or control that relate to this Agreement or, if this entire Agreement has not expired or been terminated, under any Work Order which has been terminated or has expired; and | ||
| (b) the terms, conditions and obligations under Sections 5, 6, 7, 8 and 10 will survive any such termination or expiration of this Agreement, and the terms, conditions and obligations under Section 7 will survive (and continue in full force and effect) in perpetuity. |
10. Miscellaneous.
| 10.1 | Independent Contractor. All Services will be rendered by Oncotelic as an independent contractor and this Agreement does not create an employment relationship, partnership or joint venture between GMP and Oncotelic. Oncotelic will not in any way represent itself to be a partner or joint venturer of or with GMP. | |
| 10.2 | Use of Names. Neither party has the right to use the other party’s name or the names of the other party’s employees in any advertising, sales promotional material or press release without prior written permission of the other party, except to the extent such disclosure is reasonably necessary for (a) regulatory filings, including filings with the U.S. Securities Exchange Commission or FDA, (b) prosecuting or defending litigation, and (c) complying with (i) applicable governmental regulations and legal requirements and (ii) the requirements of any stock exchange or stock listing entity. | |
| 10.3 | Notices. All notices required or permitted under this Agreement must be in writing and must be given by addressing the notice to the address for the recipient set forth in this Agreement or at such other address as the recipient may specify in writing under this procedure. Notices will be deemed to have been given (a) three (3) business days after deposit in the mail with proper postage for first class registered or certified mail prepaid, or (b) in the case of domestic deliveries, one (1) business day, and in the case of international deliveries, two (2) business days, after sending by nationally recognized overnight delivery service. | |
| 10.4 | Assignment. This Agreement may not be assigned or transferred, in whole or in part, by Oncotelic. Notwithstanding the foregoing, GMP may transfer or assign this Agreement, in whole or in part to an Affiliate, upon the consent of Oncotelic, which shall not be unreasonably withheld, conditioned or delayed; and provided that all obligations of GMP are assumed by the assignee. | |
| 10.5 | Entire Agreement. This Agreement constitutes the entire agreement of the parties with regard to its subject matter, and supersedes all previous written or oral representations, agreements and understandings between GMP and Oncotelic with regard to such subject matter. In the event of any conflict, discrepancy, or inconsistency between this Agreement and the SOW, the terms of the SOW will control as to matters of medicine and science and the Agreement will control for all other matters, unless the SOW explicitly states that its terms are meant to supersede specific terms of this Agreement. |
| 10.6 | No Modification. This Agreement and the SOW may be changed only by a writing signed by an authorized representative of each party. | |
| 10.7 | Severability; Reformation. Any of the provisions of this Agreement which are determined to be invalid or unenforceable in any jurisdiction will be ineffective to the extent of such invalidity or unenforceability in such jurisdiction, without rendering invalid or unenforceable the remaining provisions hereof and without affecting the validity or enforceability of any of the other terms of this Agreement in such jurisdiction, or the terms of this Agreement in any other jurisdiction. The parties will substitute for the invalid or unenforceable provision a valid and enforceable provision that conforms as nearly as possible with the original intent of the parties. | |
| 10.8 | Governing Law. This Agreement will be construed and interpreted and its performance governed by the laws of California, without regard to any choice of law principle that would dictate the application of the law of another jurisdiction. | |
| 10.9 | Waiver. No waiver of any term, provision or condition of this Agreement in any one or more instances will be deemed to be or construed as a further or continuing waiver of any other term, provision or condition of this Agreement. Any such waiver must be evidenced by an instrument in writing executed by an officer authorized to execute waivers. | |
| 10.10 | Counterparts; Facsimile. This Agreement may be executed in any number of counterparts, each of which will be deemed an original and all of which together will constitute one and the same instrument. This Agreement may be executed by facsimile or other form of electronic transmission. |
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.
| GOLDEN MOUNTAIN PARTNERS, LLC | ONCOTELIC, INC. | |||
| By | /s/ Clinton Teng | By | /s/ Vuong Trieu | |
| Print Name | Clinton Teng | Print Name | Vuong Trieu | |
| Title | Owner’s Representative | Title | CEO | |
[research and services agreement]
statement of work, deliverables and payments no. 1
THIS STATEMENT OF WORK, DELIVERABLES AND PAYMENT NO. 1 (the “SOW”) is by and between Golden Mountain LLC (“GMP”) and Oncotelic, Inc. (the “Oncotelic”), and upon execution will be incorporated into the Research and Services Agreement between GMP and Oncotelic dated February 3, 2020 (the “Agreement”). Capitalized terms in this Work Order will have the same meaning as set forth in the Agreement.
1. Services. Oncotelic will perform the following:
| 1) | AI/Supercomputing team: |
| a. | Deliverable: build AI model around #infection, #mortality,#cure to define the best predictive model of disease progression. This will allow us to dissect whether there are two strains or one strain of the virus. | |
| b. | Relate the spread with transportation– air and train- to see which transportation mode is being use for the spread of the virus | |
| c. | Use the model to predict choke points to stop the virus spread |
| 2) | Therapeutic Antisense team: |
| a. | Deliverable: Define the Antisense drug sequence with the best chance of inhibiting the virus. This will be done by accomplish by: |
| i. | comparing sequence of SARS, MERS, and Wuhan to define the optimal target sequence | ||
| ii. | Use our technology platform to define drug sequence with the best drug properties ie. kinetic, Thermal melting point, no CG island, safety. |
| 3) | Preclinical/Clinical team: |
| a. | Deliverable: Define the optimal evaluation pathway for going into human as package to deliver to FDA. Laying out: |
| i. | Tests to be done once the sequence define and manufacturing started | ||
| ii. | In vitro and animal tests to be done | ||
| iii. | Labs/collaborators/ KOLs to utilize for testing | ||
| iv. | Budget/Timeline | ||
| v. | Supporting safety data to allow for short safety testing |
| 4) | Drug Product team: |
| a. | Deliverable: Define the best manufacturing route for the drug |
| i. | Synthetic pathway | ||
| ii. | Recommend CDMO to use | ||
| iii. | Budget/Timeline |
2. Deliverables
| ● | An AI model to accurately determine if there is a more severe strain of the coronavirus which will have a different gene sequencing to the published strain. Thus, the more severe strain will require Oncotelic to create an antisense drug substance which is completely different from the one to inhibit the published strain. |
| ● | Creation of the formula for the coronavirus Wuhan antisense drug and gene sequencing for the antisense drug substance, including synthetic pathway and protocols for manufacturing, to inhibit the published strain of coronavirus. Initiate CDMO identification and collaboration to put in place manufacturing procedure for manufacturing of the drug substance. Also to provide onsite support to CDMO. |
| ● | Creation of a dossier supporting a proposed safety evaluation pathway of the drug substance for Chinese FDA to allow drug substance to enter clinical trials in China expeditiously. file necessary documentation and create optimal evaluation pathway to CFDA to satisfy clinical requirements and to prepare/ready the drug substance for clinical trials in China. |
3. Completion. The Services will be completed
| ● | Agreement Execution: February 3, 2020 |
| ● | Deliverables Delivered by Oncotelic: February 28, 2020 (4 weeks after Agreement execution date) |
5. Compensation. The compensation due for the Services rendered pursuant to this SOW shall not exceed Three Hundred Thousand Dollars ($300,000 USD) and will be paid according to the percentage per milestone, as follows:
| ● | On or before the date of full execution of the Agreement: $150,000 USD |
| ● | 1 week prior to delivery of Deliverables by Oncotelic: $100,000 USD |
| ● | Delivery of Deliverables by Oncotelic: $50,000 USD |
WORK ORDER AGREED TO AND ACCEPTED BY:
| GOLDEN MOUNTAIN PARTNERS, LLC | ONCOTELIC, INC. | |||
| By | /s/ Clinton Teng | By | /s/ Vuong Trieu | |
| Print Name | Clinton Teng | Print Name | Vuong Trieu | |
| Title | Owner’s Representative | Title | CEO | |
Exhibit 10.2
SUPPLEMENT TO RESEARCH AND SERVICES AGREEMENT
This SUPPLEMENT is made and entered into as of this 23rd day of March 2020 (this “Agreement”), by and among ONCOTELIC, INC., a Delaware corporation (“Oncotelic”), MATEON THERAPEUTICS, INC., a Delaware corporation (“Mateon,” and together with Oncotelic, the “Mateon Entities”), on the one hand, and GOLDEN MOUNTAIN PARTNERS, LLC, a California limited liability company (“GMP”), on the other hand, and is intended to supplement and, where applicable, amend and modify that certain Research and Services Agreement dated February 3, 2020 (the “Original Agreement”) entered into by Oncotelic and GMP. Capitalized terms used in this Agreement without definition shall have the meanings given those terms in the Original Agreement.
BACKGROUND
Pursuant to the terms of the Original Agreement, GMP and Oncotelic agreed that Oncotelic would pursue certain research activities to develop a new proprietary antisense compound (as further defined below, the “Product”) directed to the treatment of coronavirus infectious disease-19 (“COVID-19”) in humans (the “Research”).
Also pursuant to the terms of the Original Agreement, GMP agreed to provide financial support for the Research.
In consideration for the financial support for the Research provided by GMP, pursuant to the terms of the Original Agreement, GMP is entitled to obtain certain exclusive rights to the use of the Product in the COVID Field, and an economic interest in the use of the Product in the COVID Field. The purpose of this Agreement is to elaborate upon those rights.
Without limiting the foregoing, this Agreement also sets forth certain rights and obligations of the parties to use the Product, elaborating upon GMP and Oncotelic’s rights and obligations pursuant to the Original Agreement.
NOW, THEREFORE, in consideration of the foregoing, and of other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereto agree as follows:
1. Definitions. Capitalized terms used in this Agreement and not otherwise defined or defined in the Original Agreement shall have the meanings given those terms in this Section 1.
“CA4P” means Oncotelic’s proprietary Combretastatin A-4 phosphate. Combretastatin A-4 phosphate is a microtubule destabilizing drug, a type of vascular-targeting agent, a drug designed to damage the vasculature of cancer tumors causing central necrosis. It is a derivative of combretastatin. Combretastatin A-4 phosphate is a prodrug.
| 1 |
“China Territory” means the Greater Area of the People’s Republic of China, including (a) Mainland China, (b) the Hong Kong Special Administrative Region, (c) the Macau Special Administrative Region, and (d) Taiwan.
“Effective Date” means March 23rd, 2020.
“COVID Field” means all human uses of the Product for the treatment or diagnosis of COVID-19 and other diseases or health conditions caused by all coronaviruses (e.g., SARS-CoV-1 and SARS-CoV-2), whenever identified.
“Joint Venture Transaction” means the establishment of a joint venture company to be owned 50% by Oncotelic and 50% by GMP (or its designee), the principal activities of which shall be to research, develop, bring to market and commercialize: (i) the Products in the COVID Field on a global basis, (ii) the Products in the OT101 Oncology Field in the Licensed Territory, (iii) OXi4503 in the Licensed Territory; and (iv) CA4P in the Licensed Territory, as further described in Section 6.
“Licensed Territory” means the China Territory, South Korea, Vietnam, Japan, Singapore, Malaysia, Thailand, the Philippines, and the Middle East Countries.
“Middle East Countries” means Bahrain, Cyprus, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Northern Cyprus, Oman, State of Palestine, Qatar, Saudi Arabia, Syria, Turkey, United Arab Emirates and Yemen.
“OT-101” means Oncotelic’s proprietary single-stranded phosphorothioate antisense oligooxynucleotide (18-mer) targeting the human TGF-Beta2 messenger RNA, referred to by Oncotelic as Trabedersen.
“OT-101 Oncology Field” means the diagnosis, treatment or protection from the following cancers in humans: pancreatic, brain, melanoma, pediatric acute myeloid leukemia, pediatric melanoma and all other uses.
“OXi4503” means Oncotelic’s proprietary Combretastatin A1 diphosphate. Combretastatin A1 diphosphate is a diphosphate prodrug of the stilbenoid combretastatin A1. Upon administration, combretastatin A1 diphosphate (CA1P) is dephosphorylated to the active metabolite combretastatin A1 (CA1), which promotes rapid microtubule depolymerization; endothelial cell mitotic arrest and apoptosis, destruction of the tumor vasculature, disruption of tumor blood flow and tumor cell necrosis.
“2020 Patent Application” means patent application (a) 62991174, entitled “Treatment of zoonoses - Antisenses” filed by Oncotelic on or about March 18th, 2020, (b) 62991178, entitled “Treatment of zoonoses - TGF beta inhibitors” filed by Oncotelic on or about March 18th, 2020, and (c) 62992825, entitled “Treatment of zoonoses - TGF beta inhibitors” filed by Oncotelic on or about March 20th, 2020, and all divisional, continuation, continued prosecution applications, re-issue, and reexamination applications related thereto, each patent that issues or reissues from any of these patent applications; and all foreign counterparts to any of the foregoing.
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“Product” means (a) OT-101 as well as any other antisense drug candidates active against COVID-19, the use, manufacture or sale of which would, without a license or other similar rights thereto, infringe a claim of a patent issued from the 2020 Patent Application, and (b) all other compounds developed directly by Oncotelic or its affiliates or third parties through the Research.
“Testing Results” means the confirmatory lab testing results for experiments confirming the applicability and potential use of the Product for the treatment of COVID-19.
2. Product License.
(i) Effective from and after the Effective Date, the Mateon Entities grant to GMP an exclusive, sublicensable (through multiple tiers), assignable license under all patents (including the 2020 Patent Application) and know-how owned and controlled by the Mateon Entities and their affiliates to use, make, have made, sell, have sold and import Products in the COVID Field on a global basis. It is expressly understood by the Mateon Entities that this license may or may not be royalty bearing, and GMP has the full right, in its sole discretion, to donate the foregoing license rights to the public domain solely in Mainland China.
(ii) The parties acknowledge that the Product and the rights related to the Product, including the 2020 Patent Application, allocated by the parties pursuant to this Agreement constitute Deliverables under the Original Agreement.
3. Additional Research Funding. Oncotelic shall deliver the Testing Results to GMP on or before April 3, 2020. Subject to the confirmation by GMP, in its reasonable determination, of the Testing Results, GMP shall pay to Oncotelic the following amounts on the following dates:
(i) $450,000 US, within three days following the delivery of the Testing Results and GMP’s confirmation of the Testing Results; and
(ii) $450,000 US, on or before May 1, 2020.
For clarity, if the Testing Results are not delivered by Oncotelic to GMP on or before April 3, 2020, or the Testing Results are not confirmed by GMP, then neither payment set forth in this Section 3 is due or owed to Oncotelic.
4. Coordination of Additional Development Activities. From and after the Effective Date, GMP shall be entitled to use its governmental relations and local expertise in Mainland China to assist with coordinating the research, development and commercialization of Products in the COVID Field.
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5. Product Revenue. From and after the Effective Date, Oncotelic shall pay to GMP one-half of all Product Revenue (as defined below), on the terms and subject to the provisions of this Agreement.
(i) “Product Revenue” means Product Net Sales and Licensing Revenue, in each case relating to the COVID Field.
(ii) “Product Net Sales” means the total dollar amount invoiced on sales of Products by the Mateon Entities and their affiliates and sublicensees less deductions accrued in accordance with generally accepted accounting principles any charges where applicable and separately listed for (i) sales taxes or use taxes (except for value-added taxes capable of reimbursement and income taxes imposed on the sales of Products in foreign countries), tariffs, duties or customs (all separately stated on the invoice), (ii) prepaid outbound shipping and insurance charges, (iii) deductions for allowances given for returned or defective goods that do not exceed the original invoice amount, (iv) trade discounts given, not to exceed the original invoice amount, (v) charge back payments and rebates given for Products to (a) managed healthcare organizations, (b) federal, state, provincial and/or local governments or other governmental agencies, and (c) purchasers and reimbursers. Products will be considered sold when paid for; provided, however, that with respect to Products transferred by the Mateon Entities to their licensees or affiliates in the circumstances described in item (x) in the immediately following sentence, any such Products will be considered sold when they are transferred to any such licensee or affiliate. For the purpose of calculating Product Net Sales, transfers by the Mateon Entities to its licensee or affiliate of Products under this Agreement for (x) end use (but not resale) by the licensee or Affiliate shall be treated as sales by the Mateon Entities at the average amount invoiced by the Mateon Entities to third parties during such Net Sales calculation period or (y) resale by a licensee or an affiliate shall be treated as sales at the average amount invoiced by such licensee or affiliate to third parties during such Product Net Sales calculation period, in each case subject in all respects to the deductions under this Section 5(ii). Notwithstanding the foregoing, a sale of a Product to a distributor, which is not a licensee or affiliate, in an arm’s-length transaction, shall be treated as a sale if the Mateon Entities receive no further compensation for that Product from any subsequent purchaser of that Product.
(iii) “Licensing Revenue” means any and all consideration under or otherwise payable in connection with a sublicense, covenant not to sue, or grant of other or similar rights to Products received by the Mateon Entities or their affiliates, including license issue fees, lump sum payments, milestone payments, maintenance fees, profit sharing, joint marketing fee, equity or other payments of any kind whatsoever, irrespective of whether such consideration is received in the form of cash, offsets, barter, credit, stock, warrants, release from debt, goods or services, licenses back, a payment for equity that exceeds the pre-transaction fair market value by more than 125% of the equity, equity exchanges, or any other form whatsoever, excluding royalties paid to GMP based on Product Net Sales.
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(iv) Within 45 days after the end of each calendar quarter during the Term (i.e., March 31, June 30, September 30 or December 31), Oncoletic shall pay to GMP 50% of Product Revenues, in immediately available funds to an account designated by GMP.
(vi) Oncoletic may not receive as License Revenue anything of value in lieu of cash payments without the express prior written consent of GMP, such consent not to be unreasonably withheld, conditioned or delayed.
(vii) The Mateon Entities shall keep books and records sufficiently to verify the accuracy and completeness of their and their affiliates’ and licensees’ accounting, including without limitation, inventory, purchase and invoice records, manufacturing records, sales analysis, general ledgers, financial statements, and tax returns relating to the Products. The Mateon Entities shall preserve these books and records for at least six (6) years after they are created or as required by federal law, both during and after the term of this Agreement.
(viii) The Mateon Entities shall take all steps necessary so that GMP may, within thirty (30) days of its written request, audit, reasonably review and copy all of the Mateon Entities’ books and records at a single United States location to verify the accuracy of the Mateon Entities’ and their affiliates and licensees’ accounting. The review may be performed by any authorized employees of GMP as well as by any attorneys or accountants designated by GMP upon reasonable notice and during regular business hours. If a deficiency with regard to any payment is determined, Oncoletic shall pay the deficiency along with applicable interest within thirty (30) days of receiving notice. If a payment deficiency for a calendar year exceeds five percent (5%) of amounts paid for that year, then Oncoletic shall pay GMP’s out-of-pocket expenses incurred with respect to the review.
6. Formation and Contribution to Joint Venture. During the Exclusivity Period, the parties agree to facilitate due diligence by one another and subject to GMP’s satisfactory due diligence review, the parties intend to negotiate and, if mutually acceptable, enter into written definitive agreements for the Joint Venture Transaction. Pursuant to the Joint Venture Transaction: the Mateon Entities intend to license or assign intellectual property rights, including the 2020 Patent Application and any other intellectual property rights owned or controlled by the Mateon Entities relating to the Product, OXi4503 and CA4P, to the joint venture company, as well as providing management services and other expertise to the joint venture company; GMP intends that it (or its designee, as the case may be) shall provide funding to the joint venture company to support its development and commercial activities in the joint venture company’s relevant territories; in each case, on terms to be agreed by the parties; and GMP shall be entitled to use its governmental relations and local expertise in Greater China to assist with coordinating the research, development and commercialization of (i) the Products in the COVID Field, (ii) the Products in the OT101 Oncology Field, (iii) OXi4503; and (iv) CA4P, in each case in Greater China.
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7. Exclusive Negotiating Period. Commencing immediately on the date hereof and continuing until the earliest to occur of (y) 11:59 p.m., Eastern Daylight Time, on the date that is 90 calendar days after the Effective Date, and (z) the date of the execution of a written definitive agreement for the Joint Venture Transaction or any other similar transaction between the parties relating to the Products (the “Exclusivity Period”), the Mateon Entities shall, and shall instruct and cause their respective officers, directors, employees, agents, advisors, investment bankers, attorneys, accountants and other representatives to, (a) cease any and all discussions or negotiations with any third party conducted on or before the date hereof with respect to any Competing Transaction (as defined below), and (b) not, directly or indirectly, (i) solicit, initiate, seek or knowingly encourage, facilitate or induce the making, submission or announcement of any Competing Transaction, (ii) disclose to any person or entity any non-public information relating to the Product in connection with the making, submission, or announcement of, or the intent to encourage or assist, any Competing Transaction, (iii) agree to, accept, recommend or endorse (or publicly propose or announce any intention or desire to agree to, accept, recommend or endorse) any Competing Transaction, or (iv) authorize, propose or enter into any confidentiality agreement, term sheet, letter of intent, purchase agreement or other agreement, arrangement or understanding relating to any Competing Transaction; provided, that it shall not be a violation of any provision of this Agreement for the Mateon Entities to communicate with a third party that it is ceasing, terminating and/or will not enter into discussions regarding a Competing Transaction because of its obligations under this Agreement, except that the Mateon Parties shall not provide the name of the other party without the other party’s consent; provided, further, that, notwithstanding the foregoing, Oncotelic may publicly disclose any information that it reasonably determines, after having received the advice of legal counsel, it is required to disclose pursuant to applicable securities laws or listing standards. For purpose of this Agreement, the term “Competing Transaction” means with respect to the Mateon Entities (other than the Joint Venture Transaction) any transaction or business combination of any nature, including without limitation a reverse merger transaction; or any other transaction, which would prevent, preclude, limit, restrict or otherwise adversely impact the negotiation or consummation of, or materially delay, the consummation of the Joint Venture Transaction.
8. Compliance with Applicable Laws. The parties shall comply with all local, state, federal, and international laws and regulations that are applicable to their activities under this Agreement and the development, manufacture, use, and sale of Products, including:
(i) The parties acknowledge that they are subject to and agree to abide by United States laws and regulations (including the Export Administration Act of 1979 and Arms Export Control Act) controlling the export of technical data, computer software, laboratory prototypes, biological material, and other commodities. The transfer of those items may require a license from an agency of the United States Government or written assurances by the parties that it will not export items to certain foreign countries or persons without prior approval by that agency.
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(ii) Each party shall obtain all necessary approvals from the United States Food & Drug Administration, Environmental Protection Agency, Department of Agriculture and any similar governmental authorities of foreign jurisdictions in which such party intends to make, use, sell or otherwise exploit Products.
9. Assignment. This Agreement may not be transferred or assigned by the Mateon Entities (including by operation of law, in connection with a merger, share exchange or other change of control transaction) except with the prior written consent of GMP. GMP may assign any of its rights, interests or obligations hereunder, provided however that no such permitted assignment shall reduce or otherwise affect GMP’s liabilities or obligations hereunder. Any attempted assignment in contravention of this Section 9 is void and constitutes a material breach of this Agreement.
10. Confirmation of Relationship between Oncoletic and Mateon; Representations and Warranties. Oncoletic is a wholly owned subsidiary of Mateon. The Mateon Entities own or control the rights to the Products. The Mateon Entities have the right to grant all rights and licenses they purport to grant to GMP under this Agreement. The Mateon Entities have not granted any right or license to any third party that would conflict or interfere with any of the rights or licenses granted to GMP hereunder.
11. Term and Termination. The term of this Agreement shall commence on the Effective Date and shall continue until the later of (a) the 50th anniversary of the Effective Date and (b) the expiration of the last patent subject to the license set forth in Section 2.1 (the “Term”). The Mateon Entities, on one hand, or GMP on the other hand, may terminate this Agreement upon the material breach of this Agreement by the other such party(ies), provided, that the allegedly breaching party is provided with written notice of the breach and the opportunity to cure such breach for 30 days following the delivery of such written notice and the breach persists at the conclusion of this cure period. GMP may terminate this Agreement upon 30 days prior written notice. Termination or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of any party prior to such termination or expiration and any and all damages arising from any breach hereunder.
12. Entire Agreement; Agreement Controlling. This Agreement and the Original Agreement constitute the full understanding between the parties with reference to its subject matter, and no statements or agreements by the parties, whether oral or in writing, may modify the terms of this Agreement. Neither party may claim any amendment, modification, or release from any provisions of this Agreement, unless the mutual agreement is in writing and signed by both parties. If there is a conflict between this Agreement and the Original Agreement, then this Agreement shall control.
13. Further Assurances. Following the Effective Date, each of the parties shall, and shall cause their respective affiliates to execute and deliver such additional documents, instruments, conveyances and assurances and take such further actions as may be reasonably required to carry out the provisions hereof and give effect to the transactions contemplated by the Agreement and the Original Agreement.
14. Public Announcements. No party shall issue or make any press release, public announcement or other public statement with respect to this Agreement or the transactions contemplated herein without the prior consent of the other parties, except to the extent required by applicable law or by the applicable rules or requirements of any national securities exchange, market or automated quotation system; provided, that the party proposing to issue any press release, public announcement or other public statement in compliance with any such disclosure obligations shall consult in good faith with each other party before doing so.
15. General Provisions. Sections 7, 10.2, 10.3, 10.6, 10.7, 10.8, 10.9 and 10.10 of the Original Agreement, are incorporated into this Agreement by reference, as if fully set forth herein.
[signatures on following page]
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IN WITNESS WHEREOF, the parties have caused this Agreement to be entered into, and delivered by their duly authorized representatives to be effective from and after the Effective Date.
| ONCOTELIC, INC., | GOLDEN MOUNTAIN PARTNERS, LLC, | |||
| a Delaware corporation | a California limited liability company | |||
| By: | /s/ Vuong Trieu | By: | /s/ Clinton Teng | |
| Name: | Vuong Trieu | Name: | Clinton Teng | |
| Title: | CEO | Title: | Owner’s Representative | |
| MATEON THERAPEUTICS, INC. | ||||
| a Delaware corporation | ||||
| By: | /s/ Vuong Trieu | |||
| Name: | Vuong Trieu | |||
| Title: | CEO | |||
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Exhibit 99.1
Mateon to Develop its OT-101, a Phase 3 Clinical Drug Candidate, Initially Against COVID-19
OT-101- a TGF-β2 inhibitor - has demonstrated potent antiviral activity against coronavirus
OT-101- an RNA therapeutic- is part of the Company’s proprietary platform for rapid antiviral response
AGOURA HILLS, California, March 18th, 2020 — Mateon Therapeutics, Inc. (OTCQB:MATN) (“Mateon”) dedicated to development OT-101, a TGF-Beta antisense drug candidate, today provided an update on its rapid antiviral response program against coronaviruses, with a target of the coronavirus, initially the COVID-19 virus. Mateon has made significant progress in deploying its phase 3 clinical asset, OT-101, against coronavirus. In an in vitro antiviral testing performed by an independent laboratory, OT-101 has an 50% effective concentration (EC50) of 7.6 µg/mL and is not toxic at the highest dose of 1000 µg/mL giving a safety index (SI) value of >130, which is considered highly active. Mateon intends to work with the Food and Drug Administration (FDA) to permit OT-101 to enter into clinical testing against COVID-19 as soon as preclinical testing is completed. The proposed mechanism and actions for OT-101 against COVID-19 include: 1) Inhibition of cellular binding, 2) Inhibition of viral replication and 3) Suppression of viral induced pneumonia.
OT-101 is also being developed as a broad-spectrum anti-cancer drug that can also be used in combination with other standard cancer therapies to establish an effective multi-modality treatment strategy for difficult-to-treat cancers, including high-grade gliomas and pancreatic cancer. Mateon also plans to initiate phase 3 clinical trials for OT-101 in both high-grade glioma and pancreatic cancer.
In addition to therapeutic approaches for inhibiting virus replication and treating the consequences of infection, the Company is also evaluating the potential of its AI Vision technology to be deployed to help monitor patients infected with the current COVID-19 virus, or any future viruses, while simultaneously reducing the need for direct contact with hospital personnel, which poses a risk to the caregivers.
Dr. Vuong Trieu, President and Chief Executive Officer of Mateon stated: “We are excited about the potential of OT-101, against COVID-19, which has been through six clinical trials among patients with advanced cancers. OT-101 demonstrated exceptional safety profile during these trials. We believe that a similar safety profile would be demonstrated by OT-101 for coronaviruses, including COVID-19.”
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About Mateon
Mateon was created by the 2019 reverse merger with Oncotelic – a developer of TGF-beta RNA therapeutics - and the 2019 merger with PointR - a cluster computer vision empowered blockchain company creating an immuno-oncology company dedicated to the development of first in class RNA therapeutics as well as small molecule drugs against cancer. The founding team members of Oncotelic were responsible for the development of Celgene’s Abraxane as a chemotherapeutic agent for breast, lung, melanoma, and pancreatic cancer. Abraxane was approved in 2005 and has more than $1B in sales annually. The same team was also responsible for the development of Cynviloq, a next generation Abraxane, which was acquired by NantPharma for $1.3B. Mateon/Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on pediatric cancer patients. For more information, please visit www.oncotelic.com and www.mateon.com.
About Mateon’s Lead Product Candidate, OT-101
During phase 2 clinical trials in pancreatic cancer, melanoma, and colorectal cancers (Study P001) and in high-grade gliomas (Study G004), meaningful clinical benefits were observed and OT-101 exhibited a favorable safety profile. These clinical benefits included long term survival and meaningful tumor reduction. Both partial and complete responses have been observed in the G004 Phase 2 clinical trial of OT-101 as a single agent in patients with aggressive brain tumors. The company’s self-immunization protocol (SIP©) is based on novel and proprietary sequential treatment of cancers with OT-101 (an antisense against TGF-β2) and chemotherapies. This sequential treatment strategy is aimed at achieving effective self-immunization against a patients’ own cancer, resulting in robust therapeutic immune response and consequently better control of the cancer and improved survival. Prolonged states of being cancer-free have been observed in some patients with the most aggressive forms of cancer, raising a renewed hope for a potential cure. The use of OT-101 lifts the suppression of the patient’s immune cells around the cancer tissue, providing the foundation for an effective initial priming, which is critical for a successful immune response. The subsequent chemotherapy results in the release of neoantigens that result in a robust boost of the immune response.
Mateon’s Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as “may”, “expect”, “anticipate” “hope”, “vision”, “optimism”, “design”, “exciting”, “innovative”, “promising”, “will”, “conviction”, “estimate,” “intend,” “believe”, “quest for a cure of cancer”, “innovation-driven”, “paradigm-shift”, “high scientific merit”, “impact potential” and similar expressions are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about future plans, the progress, timing, clinical development, scope and success of future clinical trials, the reporting of clinical data for the company’s product candidates and the potential use of the company’s product candidates to treat various cancer indications. Each of these forward-looking statements involves risks and uncertainties and actual results may differ materially from these forward-looking statements. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. These risks are not exhaustive, the company faces known and unknown risks, including the risk factors described in the company’s annual report on Form 10-K filed with the SEC on April 10, 2019 and in the company’s other periodic filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether as a result of new information future events, or otherwise.
Contact Information:
For Mateon Therapeutics, Inc.:
Amit Shah
Email: ashah@oncotelic.com
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