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): January 3,
2019
MABVAX THERAPEUTICS HOLDINGS, INC.
(Exact name of registrant as specified in its charter)
Delaware
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001-37861
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93-0987903
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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11535 Sorrento Valley Rd., Suite 400
San Diego, CA 92121
(Address of principal executive offices and zip code)
Registrant’s telephone number, including area code:
(858) 259-9405
N/A
(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:
☐
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Written
communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
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☐
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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☐
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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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☐
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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 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
7.01
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REGULATION FD DISCLOSURE.
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On January 4, 2019, MabVax Therapeutics Holdings, Inc. (the
“Company”) issued a press release announcing the
Company had entered into discussions and letter of intent with
Oncotelic, Inc. on January 3, 2019, regarding exploration of a
potential reverse merger transaction between the two companies. The
two companies signed a non-binding letter of intent in connection
with the discussions.
The information disclosed under this Item 7.01, including Exhibit
99.1 hereto, is being furnished and shall not be deemed
“filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended, nor shall it be incorporated by
reference into any registration statement or other document
pursuant to the Securities Act of 1933, as amended, except as
expressly set forth in such filing.
ITEM 9.01
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FINANCIAL STATEMENTS AND EXHIBITS
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(d) Exhibits.
Exhibit No.
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Description
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Press
release dated January 4, 2019
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SIGNATURES
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.
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MABVAX THERAPEUTICS HOLDINGS, INC.
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Dated:
January 4, 2019
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/s/ J.
David Hansen
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J.
David Hansen
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President and Chief Executive Officer
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MabVax Therapeutics and Oncotelic Enter into Merger
Discussions
Divestiture of Selected MabVax Assets Managed by Objective Capital
Will Continue
SAN DIEGO (January 4, 2019)
–
MabVax Therapeutics
Holdings, Inc
.
(OTC Pink: MBVX), a clinical-stage
immuno-oncology drug development company with a fully human
antibody discovery platform focused on the clinical development of
products to address unmet medical needs in the treatment of cancer
and pancreatitis, today announced that it has entered into
discussions to merge with Oncotelic, Inc., a privately held cancer
immunotherapy company. Oncotelic is developing a unique
TGF-
antisense therapy which has demonstrated the
ability to break immune tolerance in mid-stage clinical trials for
the treatment of glioblastoma and pancreatic
cancer.
Based on terms of a non-binding letter of intent signed by both
companies on January 3, 2019, MabVax and Oncotelic are entering
discussions to combine the companies to form a publicly traded
company
focused on the development of proprietary
immunotherapy-based products of both companies to diagnose and
treat cancer. Under the terms of the letter of intent, Oncotelic
will merge with a wholly-owned subsidiary of MabVax in an all-stock
transaction and will become a wholly-owned subsidiary of MabVax.
The merger is subject to the approval of the MabVax board of
directors and achieving certain financing objectives and other
customary conditions. Upon closing of the transaction, MabVax will
be re-named Oncotelic, Inc. and will operate under the leadership
of the combined Oncotelic and MabVax management teams, with Vuong
Trieu, founder of Oncotelic, an experienced and successful
biotechnology entrepreneur, as executive chairman. Certain current
senior management team members at MabVax will remain with the
merged companies to fill key operational roles.
On a
pro forma basis, calculated at the close of the merger, the current
MabVax stockholders will own 25% and Oncotelic stockholders will
own 75% of the combined company, respectively. The merger agreement
contemplates securing financing of at least $10 million
simultaneous with execution of the merger to support the clinical
development of Trabedersen, Oncotelic’s
TGF-
antisense therapy,
in both glioblastoma and
pancreatic cancer trials.
Vuong
Trieu, Ph.D., who will be executive chairman of the company
post-merger, said “Our goal has been to grow a strong RNA
therapeutic company that leverages innate immunity to achieve
durable and effective immunotherapies for solid tumors and the
merger with MabVax will allow us to complement that effort with key
programs and capabilities from MabVax that will significantly
strengthen the effort.”
David
Hansen, President and CEO of MabVax, said, “Through this
transaction we hope to leverage our clinical and operational
expertise in the post-merger company to advance the clinical
development of Trabedersen while also integrating the development
of key assets discovered by MabVax. This will allow us to continue
the process of realizing the maximum value of assets we have
developed through a process already initiated with Objective
Capital while simultaneously maximizing the value of our lead
technologies for stockholders.”
On
December 13, 2018, MabVax announced that it had engaged
Objective Capital Partners, LLC to
serve as a financial advisor to assist MabVax in exploring the sale
of clinical and preclinical assets of the Company with the goal of
maximizing the value of these assets within the near term
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MabVax’s lead monoclonal antibody product, 5B1 for the
treatment of pancreatic cancer, could be one of the assets that
potentially could be developed into later stage clinical trials by
the combined company.
About MabVax Therapeutics, Inc.
MabVax
Therapeutics Holdings, Inc. is a clinical-stage biotechnology
company with a fully human antibody discovery platform focused on
the rapid translation into clinical development of products to
address unmet medical needs in the treatment of cancer and
pancreatitis. We discovered a pipeline of human monoclonal antibody
product candidates based on the protective immune responses
generated by patients who have been vaccinated against targeted
cancers. Our therapeutic vaccine product candidates were discovered
at Memorial Sloan Kettering Cancer Center (“MSK”) and
are exclusively licensed to us as well as exclusive rights to blood
samples from patients who were vaccinated with the same licensed
vaccines.
Our
lead development product, MVT-5873, is a fully human IgG1
monoclonal antibody (mAb) that targets sialyl Lewis A (sLea), an
epitope on CA19-9. MVT-5873 is currently in Phase 1 clinical
trials as a therapeutic agent for patients with pancreatic cancer
and other CA19-9 positive tumors. CA19-9 also has an important role
in the biological pathways that can result in pancreatitis. CA19-9
serum levels are considered a valuable adjunct in the diagnosis,
prognosis and treatment monitoring of pancreatic cancer and now
pancreatitis. With our collaborators including MSK, Sarah Cannon
Research Institute, Honor Health and Imaging Endpoints, we have
treated more than 56 patients with either our therapeutic antibody
designated as MVT-5873 or our PET imaging diagnostic product
designated as MVT-2163 in Phase 1 clinical studies, and
demonstrated early safety, specificity for the target and a
potential efficacy signal. The Company also has a
radioimmunotherapy product, designated as MVT-1075, that is also in
Phase 1 clinical development. For additional information,
please visit the Company's website,
www.mabvax.com
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About Oncotelic, Inc.
Oncotelic,
Inc is a
private company engaged in
developing a unique TGF-
antisense therapy which has demonstrated the
ability to break immune tolerance in mid-stage clinical trials for
the treatment of glioblastoma and pancreatic cancer.
Oncotelic’s lead therapeutic platform is OT-101. Oncotelic
intends to conduct registration trials for multiple cancer
indications including pancreatic, melanoma, and glioblastoma. The
executives of Oncotelic are a group of pharmaceutical veterans
seeking to demonstrate that OT-101 can benefit patients with
various cancers.
Additional information is available at
www.oncotelic.com
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Forward Looking Statements
This
press release contains “forward-looking statements”
regarding matters that are not historical facts. Words describing
that the Company has entered into discussions to merge with
Oncotelic, Inc. and the sections “About MabVax” and
“About Oncotelic” include such words as
“intend,” “intends,” “will,”
“achievement,” “intended,”
“contemplates,” “hope,”
“advance,” “continue,”
“exploring,” “goal,”
“maximizing,” “developing,”
“could,” “potential,” and similar
expressions, and are intended to identify forward-looking
statements. These forward-looking statements are based upon current
expectations of the Company and involve assumptions that may never
materialize or may prove to be incorrect. Actual results and the
timing of events could differ materially from those anticipated in
such forward-looking statements as a result of various risks and
uncertainties. Detailed information regarding factors that may
cause actual results to differ materially from the results
expressed or implied by statements in this press release relating
to the Company may be found in the Company’s prior periodic
filings with the Securities and Exchange Commission, including the
factors described in the section entitled “Risk
Factors” in its annual report on Form 10-K for the fiscal
year ended December 31, 2017, as amended. We undertake no
obligation to update forward-looking statements contained in this
press release.
Non-Solicitation
This communication does not constitute an offer to sell or the
solicitation of an offer to buy any securities or a solicitation of
any vote or approval. In connection with the proposed transaction
between MabVax and Oncotelic, MabVax will file relevant materials
with the Securities and Exchange Commission (the
“SEC”).
Investors
and security holders will be able to review the documents as they
are filed with the SEC by MabVax through the website maintained by
the SEC at www.sec.gov. Copies of the documents filed with the SEC
by MabVax will also be available free of charge on MabVax's website
at www.mabvax.com or by contacting MabVax's Investor Relations
Department through the links provided on MabVax's website. Other
information about MabVax is set forth in its Annual Report on Form
10-K for the year ended December 31, 2017, which was filed with the
SEC on April 2, 2018, as amended on Form 10-K/A on October 15,
2018. These documents can be obtained free of charge from the
sources indicated above. Additional information regarding the
participants and other relevant materials will be filed with the
SEC when they become available.
MabVax
Investor
Contact:
Oncotelic,
Inc. Contact:
David
Hanson, CEO
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David
Nam
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MabVaxIR@mabvax.com
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info@oncotelic.com
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858-500-8468
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818-575-9560
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