Dyadic International Inc 8-K, filed Aug 11, 2021
Dyadic International Inc (DYAI)
About this 8-K
Dyadic International Inc filed this 8-K on August 11, 2021, reporting on events of August 10, 2021.
Items reported
- Item 1.01: Entered into a material agreement
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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Emerging growth company
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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. ☐
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Title of each class
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The
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Item 9.01 Financial Statements and Exhibits
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(d) Exhibits
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The following exhibit is being filed herein:
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Exhibit
Number
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Description
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| 10.1(1) | Term Sheet for Intellectual Property License Agreement dated August 10, 2021 | |
| 99.1 | Press Release Dated August 10, 2021 | |
| 104 | Cover page Interactive Data File (embedded within the Inline XBRL document) | |
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Dyadic International, Inc.
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By:
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/s/ Mark A. Emalfarb
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Name:
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Mark A. Emalfarb
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Title:
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Chief Executive Officer
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Exhibit 10.1
Certain identified information has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful to the registrant if publicly disclosed. Information that was omitted has been noted in this document with a placeholder identified by the mark “[***]”.
TERM SHEET FOR INTELLECTUAL PROPERTY LICENSE AGREEMENT
This Term Sheet outlines the terms and conditions of an Intellectual Property License Agreement pursuant to which Dyadic International (USA), Inc. (“Licensor”) would exclusively license certain patents and patent applications, know-how, trade secrets, and other intellectual property to Sorrento Therapeutics, Inc. (“Licensee”). The terms and conditions set forth in this Term Sheet are legally binding upon the parties hereto.
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Licensor: |
Dyadic International (USA), Inc. |
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Licensee: |
Sorrento Therapeutics, Inc. |
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Licensed IP: |
All (i) Licensed Patents, and (ii) all Licensed Know-How. |
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Licensed Patents |
All (i) patents and applications owned or controlled by Licensor as of the effective date of the License Agreement or at any time during the term of the License Agreement that are necessary or useful to research, develop, make, have made, use, practice, sell, offer for sale, import, export, or otherwise commercialize Licensed Products, including but not limited to the patents and applications listed on Schedule A attached hereto, (ii) any patents issuing or claiming priority from any of the patents and patent applications referenced in clause (i) above, including non-provisionals, continuations in whole or in part, divisionals, reexaminations, and reissues thereof, and (iii) any foreign counterparts of patents and applications referenced in clauses (i) and (ii). |
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Licensed Know-How |
All data, technology, know-how, trade secrets, inventions, and any other information of any kind whatsoever (including, but not limited to, any pharmacological, biological, chemical, biochemical, manufacturing, business, and financial information), whether patentable or otherwise, copyrights, moral rights, and rights in works of authorship, and all registrations and applications for any of the foregoing, that are owned or controlled by Licensor as of the effective date of the License Agreement or at any time during the term of the License Agreement that are necessary or useful to research, develop, make, have made, use, practice, sell, offer for sale, import, export, or otherwise commercialize Licensed Products, including but not limited to the know-how and technology listed on Schedule A attached hereto.
The term “Licensed Know-How”, subject to the limitations below, shall include any cell of Thermothelomyces heterothallica (formerly Myceliophthora thermophila and originally Chrysosporium lucknowense) (“C1”) provided by Licensor or otherwise transformed or modified by Licensor, Licensee and/or an authorized third-party to produce a composition of matter suitable for use within the Field of Use. |
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License: |
Except as provided for below, an exclusive, transferable, sublicensable (through multiple tiers) right and license to the Licensed IP as described below. This license grant shall be subject to the terms of that certain Pharma License Agreement, dated December 31, 2015, between Licensor, Danisco US, Inc. and DuPont Experimental Station. |
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License Agreement: |
The parties will use all reasonable efforts to negotiate in good faith and execute the definitive license agreement that will contain terms and conditions consistent with this Term Sheet (the “License Agreement”) within forty-five (45) business days of the execution of this Term Sheet. |
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Scope of License: |
Subject to the terms and conditions of the License Agreement, an exclusive license under the Licensed IP to research, develop, make, have made, use, practice, sell, offer for sale, import, export, and otherwise commercialize the Licensed Products within the Human Field of Use in the Territory during the Term and a non-exclusive license within the Animal Field of Use in the Territory during the Term. Notwithstanding the foregoing and for the avoidance of doubt: (i) within the Territory, Licensor shall have a royalty-free, co-exclusive right to practice and use the Licensed IP, directly or through a third party, within the Field of Use solely for research and development purposes and (ii) Licensor shall retain all other rights with respect to the Licensed IP including, without limitation, with respect to the Field of Use outside of the Territory. Nothing in this Term Sheet or the License Agreement shall be deemed, directly or indirectly, to interfere with Licensor’s right and license to practice or use the Licensed IP outside of the Field of Use, including, without limitation, the development of capabilities that may be useful to make, have made, use, sell, offer to sell, export or import Licensed Products within the Field of Use and/or within or without the Territory. |
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Field of Use: |
Any and all fields of use for or in respect of the diagnosis, prophylaxis and/or treatment of any disease or condition in a human or animal by targeting any virus or subpart thereof of a coronavirus, including, without limitation, SARS-CoV-2. With respect to the foregoing, applications directed exclusively to animals other than humans shall be known as the “Animal Field of Use” and with respect to humans, the “Human Field of Use.” |
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Territory: |
Worldwide, except the Excluded Countries and Continents as set forth below.
Excluded Countries: Israel; South Korea; Singapore; Thailand; Indonesia; Malaysia; Cambodia; Myanmar; Philippines; Vietnam; Laos; and Cuba.
Excluded Continents: Africa (including Madagascar); and Indian Sub-Continent, specifically India, Pakistan, Bangladesh, Nepal, Sri Lanka, Bhutan, the Maldives, and Mauritius. |
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Licensed Product(s): |
Any product, process, service, method, composition, apparatus, or device the research, development, manufacture, use, sale, offer for sale, importation, exportation, lease disposition, or other commercialization of which would infringe, misappropriate, or otherwise violate any Licensed IP (including pending applications) but for the license granted in the License Agreement or that otherwise arose out of, embodies, is enabled by, or is covered by the Licensed IP. For the avoidance of doubt, the term “Licensed Product” shall include, without limitation, any such product, process, service, method, composition, apparatus, or device made in C1 or otherwise arising out of or relating to any Licensed Know-How transmitted to Licensee. |
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Term of the License: |
The expiration or abandonment of the Licensed IP or for so long as Licensee is developing or selling a Licensed Product (the “Term”). |
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Upfront Fee: |
Licensee would pay to Licensor an up-front license fee of ten million dollars ($10,000,000) (the “Upfront Fee”), of which Five Million Dollars ($5,000,000) will be paid in cash within thirty (30) days after the execution of the License Agreement, and the remaining Five Million Dollars ($5,000,000) will be paid in shares of restricted Licensee common stock, with the number of shares to be issued in respect thereof to be determined based on the volume weighted average price of the shares of Licensee common stock traded on The NASDAQ Stock Market LLC (“Nasdaq”) for the eleven consecutive trading days ending five trading days prior to the execution date of the License Agreement; provided, however, that for purposes of rules of NASDAQ, the total number of shares of Licensee common stock issuable as payment for a portion of the Upfront Fee shall not exceed 19.99% of the outstanding shares of Licensee common stock as of immediately prior to the execution of the License Agreement. The restricted shares shall be registered with the Securities and Exchange Commission ("SEC") pursuant to a registration statement on Form S-3 to be filed by Licensee with the SEC within thirty (30) days after the execution date of the License Agreement and Licensee shall use its best efforts to have such registration statement declared effective by the SEC within ninety (90) days after the execution date of the License Agreement, subject to Licensor promptly providing to Licensee all information regarding Licensor that is required to be included in the resale registration statement. The License Agreement shall include other reasonable and customary terms associated with such resale registration statement. |
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Royalties: |
Running Royalties: [***]% of Net Sales received in consideration for the sale of a Licensed Product which comprises any vaccine containing the sequence of a SARS-CoV-2 antigen, including without limitation, the product known as DYAI-100 or variants thereof, and [***]% of Net Sales for all other Licensed Products.
The License Agreement shall contain a combination product clause.
The running royalty may be reduced by Licensee on account of payments made to third parties under a bona fide arm’s length agreement arising out of or relating to intellectual property licensed from such third party where such intellectual property is (a) necessary to sell Licensed Products in the Territory and in the applicable Field of Use and (b) such requirement arises exclusively from the use of the Licensed IP (“Blocking Third Party IP”). In no event shall the running royalty rate be reduced by more than [***] % on account of this provision. The License Agreement shall contain provisions relating to such Blocking Third Party IP pursuant to which Licensor shall have the right and authority to negotiate a license or otherwise obtain rights or indemnify Licensee from any liability for such Blocking Third Party IP in lieu of any royalty reduction.
The royalty term expires, on a Licensed Product-by-Licensed Product and country-by-country basis, on the later of (i) 12.5 years from first commercial sale of the applicable Licensed Product in such country, or (ii) the last to expire valid claim of an issued patent comprising the Licensed Patents that would be infringed by the sale or approved use of a Licensed Product in such country.
“Net Sales” shall mean, in accordance with generally accepted accounting principles for financial reporting in the United States, consistently applied, the total gross amount invoiced by Licensee or a Permitted Sublicensee from an arms-length final commercial sale by Licensee or Permitted Sublicensee to a customer of a Licensed Product less the following discounts:
● any shipping, freight, postage, transportation, storage, and insurance costs and reasonable expenses directly relating thereto; |
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● allowances, discounts or credits given because of rejected or returned Licensed Products;
● sales, excise and similar tariffs and taxes, including customs duties;
● customary trade, quantity and cash discounts actually allowed and taken, including rebates granted; and
● customary and normal fees payable to purchasers, sales agents, distributors, resellers, group purchasing organizations, government agencies, and like entities. |
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Milestones: |
Licensee would pay Licensor the following non-refundable, non-creditable, one-time milestone payments following the first achievement by Licensee of each milestone event listed below with respect to a Vaccine Product or Therapeutic Product (as defined below):
“Vaccine Product” shall mean any Licensed Product that comprises a vaccine and is suitable for use in the Field of Use.
“Therapeutic Product” shall mean any Licensed Product that is not a vaccine and is suitable for use in the Field of Use.
Milestone Payments
● $[***] upon dosing of 1st patient in Phase 2 clinical trial in the US, Europe, Japan or China for the first Vaccine Product
● $[***] upon dosing of 1st patient in Phase 3 clinical trial in the US, Europe, Japan or China for the first Vaccine Product
● $[***] upon dosing of 1st patient in Phase 2 clinical trial in the US, EU, Japan or China for the first Therapeutic Product
● $[***] upon dosing of 1st patient in Phase 3 clinical trial in the US, EU, Japan or China for the first Therapeutic Product
● $[***] upon first marketing approval in the US for the first Vaccine Product
● $[***] upon first marketing approval in China or Japan for the first Vaccine Product
● $[***] upon first marketing approval in Europe for the first Vaccine Product
● $[***] upon first marketing approval in the US for the first Therapeutic Product |
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● $[***] upon first marketing approval in China or Japan for the first Therapeutic Product
● $[***] upon first marketing approval in Europe for the first Therapeutic Product
● $[***] upon first marketing approval in the US for the first animal Vaccine Product
● $[***] upon first marketing approval in China or Japan for the first animal Vaccine Product
● $[***] upon first marketing approval in Europe for the first animal Vaccine Product
● $[***] upon first marketing approval in the US for the first animal Therapeutic Product
● $[***] upon first marketing approval in China or Japan for the first animal Therapeutic Product
● $[***] upon first marketing approval in Europe for the first animal Therapeutic Product |
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Patent Prosecution: |
Licensor would be responsible for filing, prosecution and maintenance (collectively, “Prosecution”) of all Licensed Patents at Licensee’s expense, provided that Licensor would keep Licensee informed as to the status of the Prosecution, provide Licensee copies of all material correspondence to and from the patent offices and provide Licensee with opportunities to comment and reasonably accommodate those comments.
The License Agreement will have customary provisions relating to Prosecution. |
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Enforcement: |
Licensor would have first right of enforcement, but if Licensor declines to enforce the Licensed IP in the Territory and in the Field of Use, Licensee would have the right, subject to additional customary limits in the License Agreement, to enforce the Licensed IP.
The License Agreement will have customary provisions relating to enforcement. |
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Development & Commercialization: |
Licensee shall use commercially reasonable efforts to and assume full responsibility for all future development and commercialization of the Licensed Product(s) at its own expense.
Licensor shall have the option, with respect to Vaccine Products, to convert the exclusive license granted under the License Agreement to a non-exclusive license if the Licensee fails to initiate a Phase 2 trial of a Vaccine Product by [***], such period which may be extended by mutual agreement of the parties; furthermore, any non-exclusive rights relating to Vaccine Products shall terminate automatically if such Phase 2 has not been initiated by [***]. |
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Licensor shall have the option, with respect to Therapeutic Products, to convert the exclusive license granted under the License Agreement to a non-exclusive license if the Licensee fails to initiate a Phase 1 trial of a Therapeutic Product by [***], such period which may be extended by mutual agreement of the parties; furthermore, any non-exclusive rights relating to Therapeutic Products shall terminate automatically if such Phase 1 has not been initiated by [***].
Licensor shall have the option, with respect to either Human Vaccine Products and/or Therapeutic Products, to convert the exclusive license granted under the License Agreement to a non-exclusive license if the Licensee fails to initiate a Phase 1 trial of a Licensed Product within one (1) year of the World Health Organization and/or the Centers for Disease Control declaring a “pandemic” with respect to a coronavirus other than SAR-CoV-2 and its variants of concern in the Territory.
Additionally, Licensee shall reimburse Licensor all preclinical and clinical development costs that were incurred by Licensee prior to the effective date of the License Agreement in connection with the development of Licensed Products, provided that such reimbursement shall not exceed four million dollars ($4,000,000). Any reimbursement would be paid within thirty (30) days of receipt of invoice and supporting documentation. |
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Transfer and Sublicense Rights |
Licensee shall have sublicense rights as is reasonably required to, on its own behalf, exercise the rights provided for herein. All such sublicense rights shall be made to an entity of equal or superior capabilities as Licensee and shall be subject to the prior written approval of the Licensor, such consent not to be unreasonably withheld, delayed or conditioned (a "Permitted Sublicensee” and a “Permitted Sublicense”). Without limiting the generality of the foregoing, it shall be unreasonable for Licensor to withhold approval of a potential sublicensee if such potential sublicensee has capabilities commensurate with or greater than Licensee’s capabilities. All Permitted Sublicenses shall be pursuant to a written agreement by which the Permitted Licensee, whose performance shall be guaranteed by Licensee, shall covenant to abide by all of the terms of the License Agreement and such Permitted Sublicense shall name Licensor as a third-party beneficiary with a right of enforcement. The rights provided for herein shall not extend to either the transfer of all or substantially all of the rights to any Licensed Product, either directly or via sublicense, to a third party where such transfer or sublicense permits such third party to control the development, sale, offer for sale, manufacturing, or other commercial aspects of the Licensed Product. In the event a Permitted Sublicense is executed, Licensor shall be entitled to [***] of any upfront payment made to Licensee on account of such Permitted Sublicense. |
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Manufacturing: |
Licensee shall assume full responsibility for the clinical and commercial manufacture and supply of the Licensed Product at its own expense. |
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Chemistry, Manufacturing and Control (“CMC”) Materials: |
Licensor will provide Licensee with drug material related to the DYAI-100 and manufactured under cGMP conditions, whether or not currently qualified, which is currently in its or its affiliates’ possession (the License Agreement will include an appendix listing the exact amount and description of such materials). Upon transfer of the drug material provided for herein, Licensor shall promptly provide Licensee with the release criteria and other relevant information from the contract manufacturer who produced the drug material. Such release shall be “as is” and without any warranty or representation. |
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Additional Provisions |
The License Agreement will include additional provisions providing, inter alia, audit, inspection and books and records rights, a right of reference by Licensor for regulatory filings relating to any Licensed Product on its own behalf and on behalf of its other licensees, reporting obligations, regulatory review and interaction rights and pharmacovigilance. |
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Technology Transfer: |
The License Agreement will include mutually agreed provisions governing (a) the transfer of Licensed IP to Licensee necessary or useful to enable Licensee to fulfill its development and commercialization obligations under the License Agreement, including necessary or reasonably useful biological materials, reagents and manufacturing processes, and (b) the manufacture of clinical supply of the Licensed Products. If requested by Licensee, Licensor, or its collaborator(s) shall provide reasonable assistance to Licensee, such assistance to be reimbursed by Licensee at an hourly rate, such hourly rate not to exceed €[***] per FTE as calculated on an annual basis.
Licensee agrees that, as partial consideration of access to the Licensed Know-How and the lease of C1 strains and related tools, that any and all inventions, discoveries, improvements, extensions of the Licensed IP, arising out of or relating to the Licensed Know-How (“New IP”), whether patentable or not, shall be owned by Licensor and, pursuant to the terms of the License Agreement, licensed back to Licensee. For the sum of One Dollar ($1) Licensee, on its own behalf and on behalf of any third party it controls, hereby assigns its entire right, title and interest in and to such New IP. The License Agreement shall have appropriate provisions relating to disclosure, filing, prosecution, and enforcement of any potentially patentable inventions covered by the foregoing provision. |
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Miscellaneous: |
The License Agreement would include other customary terms and conditions, including, without limitation, representations, warranties, covenants and indemnities by each party and customary confidentiality, termination and dispute resolution provisions. |
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Nature of Term Sheet: |
It is the intention of the parties referenced in this Term Sheet that this Term Sheet be a legally binding obligation of such parties. |
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Confidentiality: |
Neither party will disclose the terms of this Term Sheet to any person or entity other than such party’s officers, members of the Board of Directors, accountants, attorneys and other advisors who are bound to such party by a duty of confidentiality, in any case without the written consent of the other party. |
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Governing Law and Disputes: |
This Term Sheet and the License Agreement will be governed by Delaware law, without regard to conflicts of law principles. |
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Expenses: |
Each party will bear its own expenses incurred in the drafting and negotiation of this Term Sheet and the License Agreement. |
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Exclusivity: |
For the period commencing on the date on which both parties have executed this Term Sheet (the “Effective Date”) and ending at 5:00 p.m. San Diego, California local time on the date that is Forty Five (45) days from the Effective Date (the “Exclusivity Period”), Licensor (including its directors, officers, managers, employees and professional advisors) will negotiate exclusively and in good faith with Licensee with respect to entering into the License Agreement and the other matters contemplated by this Term Sheet. During the Exclusivity Period, Licensor (including its directors, officers, managers, employees and professional advisors) will not, directly or indirectly, solicit, initiate, seek, entertain, knowingly encourage, knowingly facilitate or support any inquiry, proposal or offer from, furnish any information to, or participate in any discussions or negotiations with, any person or entity other than Licensee and its representatives with respect to any sale or other disposition of any equity securities of Licensor, or any merger, consolidation, business combination or similar transaction, any sale, license, lease or other disposition of all or substantially all of the assets of Licensor or any assets related to the Licensed Products (a “Competing Proposal”), or enter into any agreement with any such other person or entity concerning such a transaction. Licensor further covenants and agrees to terminate any such discussions or negotiations in respect of a Competing Proposal in progress as of the Effective Date. If Licensor (including any of its directors, officers, managers, employees or professional advisors) receives an offer or expression of interest to make an offer for a Competing Proposal from a third party, Licensor will promptly (but in any event within 24 hours) notify Licensee in writing of the terms and conditions of such offer and the identity of the person or entity making such offer. Nothing in this provision is intended to prevent or delay Licensor from undertaking any ordinary course activities unrelated to the out-licensing of Licensed IP in the Field of Use, including, without limitation, consummating the sale of equity securities. |
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Expiration: |
The proposals under this Term Sheet will expire unless this Term Sheet is accepted by Dyadic International (USA), Inc. prior to 5:00 p.m. Pacific Time on August 12, 2021 (the “Term Sheet Deadline”). In the event this Term Sheet is executed by the Term Sheet Deadline, this Term Sheet shall terminate upon the earliest to occur of: (i) execution of the License Agreement by each of the parties or (ii) mutual written agreement of the parties. |
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Publicity: |
Following the execution of this Term Sheet, each party may issue a press release in substantially the form presented to and approved by the other Party concurrently with the execution of the applicable agreement, with such approval not to be unreasonably withheld, conditioned or delayed. Notwithstanding anything herein to the contrary in this Term Sheet, both parties shall be free to make any disclosure if required to (i) comply with the requirements of any applicable laws (in which case such party shall notify the other party promptly and shall use commercially reasonable efforts to provide the other party with a copy of the contemplated disclosure prior to submission or release, as the case may be); (ii) enforce any right or remedy of any right or remedy relating to this Term Sheet or (iii) as required to any potential partner, financing source, advisor or similar entity provided that such third party execute a confidentiality agreement at least as restrictive as the confidentiality provided for herein. Without limiting the foregoing, each party shall be permitted to publicly disclose this Term Sheet, and/or the terms contained herein or therein to the extent required by applicable law or regulation. |
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[Remainder of Page Intentionally Left Blank] |
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This Term Sheet For Intellectual Property License Agreement is accepted and agreed to by Sorrento Therapeutics, Inc. and Dyadic International (USA), Inc. as of the date(s) set forth below:
| SORRENTO THERAPEUTICS, INC. | DYADIC INTERNATIONAL (USA), INC. |
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By: /Henry Ji/ |
By: /Mark Emalfarb/ |
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Name: Henry Ji, Ph.D. |
Name: Mark Emalfarb |
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Title: Chairman, President and CEO |
Title: CEO |
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Date: August 10, 2021 |
Date: August 10, 2021 |
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Sorrento Legal Approved |
SCHEDULE A
Licensed IP
| [***] | |
| [***] | [***] |
| [***] | [***] |
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[***]
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[***] |
Exhibit 99.1
DYADIC AND SORRENTO ANNOUNCE BINDING TERM SHEET TO LICENSE DYADIC’S LEAD COVID-19 VACCINE CANDIDATE “DYAI-100” AND C1 TECHNOLOGY FOR PROTEIN-BASED CORONAVIRUS VACCINES AND THERAPEUTICS
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● |
Sorrento to obtain exclusive rights in North and South America, Europe, major Asian countries (including Greater China and Japan) and certain other countries to utilize Dyadic’s C1 technology for the development and commercialization of vaccines, therapeutics antibodies, protein therapeutics, and diagnostics for coronaviruses, including DYAI-100, Dyadic’s lead COVID-19 vaccine candidate |
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Exclusivity is subject to Sorrento’s timely achievement of certain development milestones |
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Expands Sorrento’s extensive COVID-19 programs and corporate mission to develop novel vaccines and therapeutic treatments for unmet needs |
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Consideration includes a $10 million up-front payment ($5 million in cash and $5 million in Sorrento stock), reimbursement of certain DYAI-100 R&D expenses, with potential for multiple future development milestones and royalty payments |
JUPITER, FL / August 11, 2021 Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the “Company”) (NASDAQ: DYAI), a global biotechnology company focused on further improving, applying and deploying its proprietary C1-cell protein production platform to accelerate development, lower production costs and improve access to biologic vaccines and drugs at flexible commercial scales, and Sorrento Therapeutics, Inc. ("Sorrento") (NASDAQ: SRNE), a clinical stage biopharmaceutical company developing new therapies to treat cancer, pain and COVID-19, today announced the signing of a binding term sheet to enter into a License Agreement to develop and commercialize vaccines, therapeutics, and diagnostics for coronaviruses, , including Dyadic’s lead COVID-19 vaccine candidate, DYAI-100, produced using Dyadic's proprietary and patented C1-cell protein production platform. The final terms of the license will be set forth in a definitive agreement to be entered into between the parties.
Sorrento’s Chairman and CEO, Dr. Henry Ji, commented, “We look forward to continuing our collaboration with Dyadic, which began last year, initially with a goal of developing and commercializing a protein-based COVID-19 vaccine that can be rapidly manufactured in large quantities in our existing cGMP facilities, and stored and transported at room temperature, in order to increase access and affordability to underserved populations globally.” Dr Ji. continued, “Over the past six months we have carried out several promising preclinical animal trials using the C1 produced RBD antigen in Dyadic’s lead COVID-19 vaccine candidate, DYAI-100. Our goal is to manufacture a COVID-19 vaccine that will provide protection across the variants of concern, including Delta, and in addition, apply the C1 protein production platform broadly across our current and future coronavirus programs”.
Mark Emalfarb, Dyadic’s President and Chief Executive Officer noted, “We are delighted to have executed a binding term-sheet with Sorrento Therapeutics to license the C1 technology for the development and commercialization of coronavirus vaccines, therapeutics, and diagnostics, including COVID-19. This marks a significant milestone in our corporate development efforts as we expect the license agreement we will enter into to enable us to monetize our internal COVID-19 development efforts with a partner that has the resources and expertise to advance vaccines, therapeutics, and diagnostics both clinically and commercially”.
“The license agreement, when executed, contemplates an up-front payment of $10 million in cash and stock, up to $4 million in reimbursements for preclinical and clinical development costs incurred by Dyadic for the development and advancement of our proprietary DYAI-100 vaccine, up to $33 million in milestone payments and ongoing royalties following commercialization. All future development costs related to this license will be incurred by Sorrento”, concluded Mr. Emalfarb.
Mr. Michael Tarnok, Dyadic’s Board Chairman noted, “This is a significant event for Dyadic and humankind globally, having achieved our goal of creating a pathway that potentially addresses the COVID-19 vaccine production gap for mass scale immunizations and treatments across the globe, quickly and efficiently. The Sorrento license will cover all other territories not already covered by Dyadic’s existing COVID-19 agreements with Medytox, Syngene and the Rubic Consortium”.
About Sorrento Therapeutics Inc.
Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers and COVID-19. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), clinical stage immuno-cellular therapies (“CAR-T”, “DAR-T™”), antibody-drug conjugates (“ADCs”), and clinical stage oncolytic virus (“Seprehvir™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™, COVI-STIX™ and COVITRACE™.
Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by its effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a Phase IB trial for intractable pain associated with cancer and a Phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. ZTlido® was approved by the FDA on February 28, 2018.
For more information visit www.sorrentotherapeutics.com.
About Dyadic International, Inc.
Dyadic International, Inc. is a global biotechnology company that is developing what it believes will be a potentially significant biopharmaceutical gene expression platform based on the fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila), named C1. The C1 microorganism, which enables the development and large-scale manufacture of low-cost proteins, has the potential to be further developed into a safe and efficient expression system that may help speed up the development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales. Dyadic is using the C1 technology and other technologies to conduct research, development and commercial activities for the development and manufacturing of human and animal vaccines and drugs, such as virus like particles (VLPs) and antigens, monoclonal antibodies, Fab antibody fragments, Fc-Fusion proteins, biosimilars and/or biobetters, and other therapeutic proteins. Certain other research activities are ongoing, which include the exploration of using C1 to develop and produce certain metabolites and other biologic products. Dyadic pursues research and development collaborations, licensing arrangements and other commercial opportunities with its partners and collaborators to leverage the value and benefits of these technologies in development and manufacture of biopharmaceuticals. As the aging population grows in developed and undeveloped countries, Dyadic believes the C1 technology may help bring biologic vaccines, drugs, and other biologic products to market faster, in greater volumes, at lower cost, and with new properties to drug developers and manufacturers, and improve access and cost to patients and the healthcare system, but most importantly save lives.
Please visit Dyadic's website at http://www.dyadic.com for additional information, including details regarding Dyadic's plans for its biopharmaceutical business.
Safe Harbor Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements other than statements of historical fact are forward-looking. Examples of forward-looking statements include, but are not limited to, statements regarding Dyadic's expectations, intentions, strategies, and beliefs pertaining to future events or future financial performance. Forward-looking statements generally can be identified by use of the words “expect,” “should,” “intend,” “aim,” “anticipate,” “believe,” “will,” “project,” “may,” “might,” “potential,” “pursue,” or “continue” and other similar terms or variations of them or similar terminology. However, not all forward-looking statements contain these words. Actual events or results may differ materially from those in the forward-looking statements because of various important factors, including
(1) the expected entry into a definitive license agreement with Sorrento, (2) the development and commercialization of COVID-19 vaccines, including DYAI-100, and therapeutic antibodies, protein therapeutics and diagnostics for coronaviruses; (3) the properties of DYAI-100, including its induction of high-titer neutralization activity against SARS-CoV-2 and its variants of concern, (4) the capability to manufacture protein-based vaccines in large quantities; (5) the resources and expertise of Dyadic and its partners in developing and commercializing vaccines, therapeutics and diagnostics; (6) the expectation that such vaccines would be effective against SARS-CoV-2 and its variants of concern; (7) general economic, political and market conditions; (8) our ability to generate the required productivity, stability, purity, performance, cost, safety and other data necessary to carry out and implement our biopharmaceutical research and business plans and strategic initiatives; (9) our ability to implement and successfully carry out Dyadic’s and third parties’ research and development efforts; (10) the pharmaceutical and biotech industry, governmental regulatory and other agencies’ willingness to adopt, utilize and approve the use of the C1 gene expression platform; and (11) other factors described in the Company's most recent filings with the SEC. Given these risks and uncertainties, you should not place undue reliance on any forward-looking statements. The forward-looking statements contained in this press release are made only as of the date hereof, and Dyadic does not intend, and except as required by law assumes no obligation to update publicly any such forward-looking statements, whether because of new information, future events or otherwise. For a more complete description of the risks that could cause our actual results to differ from our current expectations, please see the section entitled "Risk Factors" in Dyadic's annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”), as such factors may be updated from time to time in Dyadic's periodic filings with the SEC, which are accessible on the SEC's website and www.dyadic.com.
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Contacts:
Sorrento Therapeutics Inc.
Alexis Nahama, DVM
SVP Corporate Development
Email: mediarelations@sorrentotherapeutics.com
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Dyadic International, Inc.
Ping W. Rawson
Chief Financial Officer
Phone: (561) 743-8333
Email: prawson@dyadic.com