JACKSONVILLE, Fla.,
May 15, 2018 /PRNewswire/ --
TapImmune Inc. (NASDAQ: TPIV) ("TapImmune") today announced that it
has entered into a definitive merger agreement to acquire Marker
Therapeutics, Inc. ("Marker"), a privately-held clinical-stage
developer of a transformative, non-genetically engineered,
multi-antigen T cell therapy platform. The proposed transaction
will be a merger-of-equals under which the stockholders of
TapImmune and Marker will each own approximately 50% of the
combined company, prior to any issuances of additional shares in a
contemplated financing. The proposed merger remains subject to
certain conditions, including that financing and the approval of
TapImmune stockholders. TapImmune and Marker will host a conference
call and webcast today at 8:00 a.m.
ET.
Peter Hoang, President and CEO of
TapImmune, stated, "I believe that the new therapies we are
acquiring with Marker in this transaction represent the next major
leap forward in cell therapy for cancer. The merger adds to our
product pipeline a synergistic portfolio of highly-differentiated T
cell therapies that has demonstrated potentially groundbreaking
results in early clinical trials in lymphoma, acute myeloid
leukemia (AML), and multiple myeloma."
"With this merger, I believe we have the opportunity to
significantly disrupt the CAR-T and TCR field," added Mr. Hoang.
"Compared to current gene-modified T cell therapies such as CAR-T
and TCR, the therapies we are acquiring in this transaction
are:
- Highly efficacious and extremely durable, without the need
for lymphodepletion before infusion: In our Phase I lymphoma
study, we saw complete responses (CRs) in 50-60% of our evaluable
patients, a rate comparable to the best reported CAR-T studies in
lymphoma. However, unlike in CAR-T studies, we have yet to see a
single disease relapse in any responder, whereas typically 30% or
more of patients with CR in today's CAR-T studies relapse within
one year. In fact, more than half of our CRs are in durable
remission beyond a year, with several patients being relapse-free
beyond 2-3 years.
- Non gene-modified: Unlike current CAR-T and TCR
approaches, our cell therapeutic approach requires no genetic
modification of T cells, which will allow us to manufacture the
product at a fraction of the cost, with substantially reduced
complexity of manufacturing.
- Significantly less toxic than CAR-T: With more than 60
patients treated, our therapies have never caused cytokine release
syndrome (CRS) or a related serious adverse event (SAE) in patients
treated with our therapy. In fact, we have seen only one grade III
adverse reaction that was considered possibly related in our
patients to date, versus a 95% incidence rate of grade III or
higher adverse events in recent CAR-T studies.
- Multi-antigen specific: Our new technology identifies
and selects for substantially all T cells that are specific to any
peptide epitope of the antigens we target, including very rare
clones that are otherwise undetectable in our deep gene sequencing
of patients' peripheral blood. Compared to current CAR-T and TCR
approaches, which target a single epitope of only one target
antigen, our multi-specific T cell therapy products that are
currently in clinical trials have been shown to consist of
approximately 4,000 unique T cell clonotypes targeting up to five
different tumor-associated antigens.
- Capable of driving an endogenous immune response: We see
consistent evidence of "epitope spreading" in our patients, meaning
that our therapy is inducing the patient's native T cells (that are
specific to tumor associated antigens that are not targeted by our
infused product) to expand and contribute to a lasting anti-tumor
effect. This phenomenon, also known as "antigen spreading," has
been the stated goal of many CAR-T and TCR developers, but we
believe that our therapy is the first to show a consistent ability
to drive this effect.
- Capable of addressing patients currently inaccessible to
CAR-T therapies: Because our product is derived from natural
patient T cells without gene modification, we are able to treat
patients earlier and in indications that are currently not
addressable by CAR-T therapies. We have seen strong patient
responses that are highly durable, while seeing no associated graft
versus host disease (GvHD) in post-transplant relapsed/refractory
AML, a setting where currently the only available alternative
therapy is a donor lymphocyte infusion (DLI). DLIs generally have
very low patient response rates with high rates of severe
associated GvHD. CAR-T approaches cannot currently be used in
post-transplant relapsed/refractory AML because most envisioned
CAR-T therapies are targeted to antigens expressed on hematopoietic
stem cells, potentially causing fatal neutropenia. Furthermore, our
therapies can be used as maintenance therapies and in earlier
treatment settings than can CAR-T or TCR approaches, which would
generate significant toxicities in those settings."
"Executing this strategic merger with Marker Therapeutics will
be fundamentally transformational for TapImmune, enriching our
strong immuno-oncology pipeline with a revolutionary multi-antigen
targeted cell therapy platform. We believe this technology will be
a game-changer for the cell therapy industry, potentially
overcoming the well-known limitations of today's CAR-T and TCR
approaches," concluded Mr. Hoang. "Combined with the four ongoing
Phase 2 clinical trials in the TapImmune platform, I believe we are
creating a best-in-class cancer immunotherapy platform. With
Marker's peptide-based cell therapy platform, we believe that there
is an excellent fit with TapImmune's extensive experience and
expertise in the research, development, manufacturing and
manipulation of peptide-based immunotherapies. Furthermore, the
integration of the two companies provides us with a compelling
opportunity to create a unique and highly differentiated company in
the immuno-oncology field."
John Wilson, CEO of Marker, said,
"I feel very fortunate to have been entrusted with one of the
premier programs of Baylor College of
Medicine's Center for Cell and Gene Therapy, and to
integrate it with TapImmune to provide this exceptional technology
with a strong commercial pathway. We have great respect for the
work that the TapImmune team has done within the immuno-oncology
field and believe integrating our respective peptide-based
technologies will drive significant advances in the field. By
combining TapImmune's experience and expertise in multi-epitope
peptide-based approaches to T cell activation with Marker's
multi-targeted T cell therapy, while simultaneously leveraging the
know-how and facilities of Baylor College of
Medicine's Center for Cell and Gene Therapy, we intend to
chart a groundbreaking course toward more effective, less complex,
non-toxic and cost-effective cancer treatments. Our respective
development teams are eager to join forces and drive a unique
product pipeline to patients in need. We believe the merger will
accelerate clinical development, particularly for the cell therapy
platform, which has generated encouraging patient responses in our
clinical trials to date. I look forward to taking a position on the
post-merger Board of Directors where I can leverage my T cell
manufacturing expertise and help the Company implement a highly
practical and economical manufacturing platform. By avoiding the
need for genetic engineering, the manufacturing process can be
greatly simplified, providing us with a great opportunity to
successfully address the cost issues that currently plague the
field."
In conjunction with the transaction, TapImmune intends to
finalize a strategic alliance with Baylor
College of Medicine which will include sponsored research,
manufacturing support, and advancing early stage clinical trials at
the institution.
Merger Related Financing
TapImmune is currently in discussions with a syndicate of
leading healthcare-focused institutional investors with respect to
a potential financing in conjunction with the merger that will be
expected to fund the combined company into 2020.
Private Placement of Common Stock, Warrant Exercises and
Financing Commitment
In support of TapImmune's initiatives, including the merger, the
Company has entered into agreements with certain institutional
stockholder and warrant holders that are expected to provide the
Company with approximately $5.1
million in equity financing. The Company's largest
stockholder, Eastern Capital Limited, has entered into a Common
Stock Purchase Agreement with the Company pursuant to which it will
purchase 1.3 million shares of common stock at a price per share of
$2.40 providing gross proceeds to the
Company of approximately $3.1
million. Other selected institutional holders of outstanding
warrants have entered into warrant amendment agreements with the
Company to exercise their warrants at an exercise price of
$2.50 per share. Upon closing of the
warrant amendment agreements, such participating institutional
holders will exercise approximately 783,000 warrants providing
aggregate proceeds to the Company of approximately $2.0 million.
In addition, Mr. John Wilson, CEO
of Marker, has provided a written commitment for additional
financing to the Company of up to $1.0
million.
About the Proposed Merger
Existing Marker stockholders will receive newly issued shares
and warrants of TapImmune common stock in connection with the
proposed merger equal to the number of shares and warrants of
TapImmune outstanding at the closing of the merger. TapImmune
currently has 10.7 million shares of common stock and approximately
7.0 million warrants and options outstanding (excluding any shares
issuable in connection with the financing referenced above).
The number of warrants issuable to Marker are subject to increase
based upon certain conditions related to the terms of any
additional financing closed concurrently with the merger. On a pro
forma basis for the combined company, current TapImmune
stockholders and current Marker stockholders are each expected to
own approximately 50% of the combined company, prior to the
contemplated issuance of shares in the financing that is expected
to occur concurrently with the merger.
The transaction has been unanimously approved by the board of
directors of both companies. The proposed merger is expected to
close in the second half of 2018, subject to completion of the
concurrent financing and the approval of the stockholders of each
company as well as other customary conditions. The merger agreement
contains further details with respect to the proposed merger.
Nomura Securities International, Inc. acted as the exclusive
financial advisor to TapImmune. Seyfarth Shaw LLP served as legal
counsel to TapImmune. Winthrop & Weinstine, PA served as legal
counsel to Marker.
Management and Organization
Following the closing of the proposed merger, TapImmune CEO
Peter Hoang will be President and
CEO of the combined company. Marker CEO John Wilson will join the combined company's
Board of Directors as will Juan
Vera, M.D., a Co-Founder of Marker. The board of directors
of the combined company is expected to consist of eight members,
three of whom will be designated by TapImmune, three of whom will
be designated by Marker, and two of whom will be designated by the
investor syndicate. In addition, Marker Co-Founder
Ann Leen, Ph.D. will be appointed to
the new position of Chief Scientific Officer. Michael Loiacono will continue to serve as Chief
Financial Officer and Richard
Kenney, M.D. will continue as Acting Chief Medical Officer.
Additionally, TapImmune is expected to announce the formation of a
new Scientific Advisory Board which will become effective on the
closing date of the merger.
Additional Information about the Proposed
Merger
In connection with the proposed merger, TapImmune intends to
file relevant materials with the Securities and Exchange
Commission, or the SEC, including a proxy statement. Investors and
security holders of TapImmune are urged to read these materials
when they become available because they will contain important
information about TapImmune, Marker and the proposed merger. The
proxy statement and other relevant materials (when they become
available), and any other documents filed by TapImmune with the
SEC, may be obtained free of charge at the SEC web site at
www.sec.gov. In addition, investors and security holders may obtain
free copies of the documents filed with the SEC by TapImmune by
directing a written request to: TapImmune Inc., 5 West Forsyth
Street, Suite 200, Jacksonville,
FL 32202, Attn: Investor Relations. Investors and security
holders are urged to read the proxy statement and the other
relevant materials when they become available before making any
voting decision with respect to the proposed merger.
This communication shall not constitute an offer to sell or the
solicitation of an offer to sell or the solicitation of an offer to
buy any securities, nor shall there be any sale of securities in
any jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No offering of securities
in connection with the proposed merger shall be made except by
means of a prospectus meeting the requirements of Section 10
of the Securities Act of 1933, as amended.
Participants in the Solicitation
TapImmune and its directors and executive officers may be deemed
to be participants in the solicitation of proxies from the
stockholders of TapImmune in connection with the proposed
transaction. Information regarding the special interests of these
directors and executive officers in the proposed merger will be
included in the proxy statement referred to above. Additional
information regarding the directors and executive officers of
TapImmune is also included in its Annual Report on Form 10-K for
the year ended December 31, 2017, filed with the Securities
and Exchange Commission (the "SEC") on March
23, 2018. This document is available free of charge at the
SEC's web site (www.sec.gov) and from Investor Relations at
TapImmune at the address described above.
Conference Call and Webcast Information
The companies will host a conference call and live audio webcast
today, May 15, 2018, at 8:00 a.m. ET. Interested participants and
investors may access the conference call by dialing:
- 1 (855) 238-2333 (U.S.) or
- 1 (412) 317-5215 (International)
To access the live audio webcast, visit the Events section of
the TapImmune website http://tapimmune.com/events/. The webcast
will be archived for 90 days beginning at approximately
10:30 a.m. ET, on May 15, 2018.
About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a clinical stage immuno-oncology
company focused on developing adoptive non-gene modified T cell
therapies for the treatment of hematologic malignancies such as
Acute Myeloid Leukemia, Lymphoma, and Multiple Myeloma. Marker's
MultiTAA technology selectively expands non-engineered T cells,
enhancing them with the ability to kill tumor cells by targeting
multiple tumor-associated antigens simultaneously to prevent immune
escape and generate durable immunity. Patient/donor T cells are not
genetically modified and therefore the cost of generating Marker's
therapies is significantly reduced. Furthermore, safety has been
demonstrated to date in more than 60 patients, with no related
serious adverse events or cytokine release syndrome. The Company is
preparing for Phase 2 clinical trials.
About TapImmune Inc.
TapImmune Inc. is a leader in the development of novel
immunotherapies for cancer, with multiple Phase 2 and Phase
1b/2 clinical studies currently
ongoing for the treatment of ovarian and breast cancer. The
Company's peptide or nucleic acid-based immunotherapeutic products
comprise multiple naturally processed epitopes (NPEs) that are
designed to comprehensively stimulate a patient's killer T cells
and helper T cells, and to restore or further augment antigen
presentation using proprietary nucleic acid-based expression
systems. This unique approach can produce off-the-shelf T cell
vaccine candidates that elicit a broad-based T cell response and
can be used without respect to HLA type. The Company's technologies
may be used as stand-alone medications or in combination with other
treatment modalities.
For additional information, please visit:
https://tapimmune.com/
To receive future press releases via email, please visit:
https://tapimmune.com/investors/email-alerts/
Follow us on Twitter @TapImmune_Inc, or follow us on
Facebook.
For answers to frequently asked questions, please visit our FAQs
page:
https://tapimmune.com/investors/frequently-asked-questions/
Forward-Looking Statement Disclaimer
This release contains forward-looking information within the
meaning of the Private Securities Litigation Reform Act of 1995.
Statements in this news release concerning the proposed merger and
the company's expectations, plans, business outlook or future
performance, and any other statements concerning assumptions made
or expectations as to any future events, conditions, performance or
other matters, are "forward-looking statements". Forward-looking
statements are by their nature subject to risks, uncertainties and
other factors which could cause actual results to differ materially
from those stored in such statements. Factors that could cause such
differences include, but are not limited to, (i) the risk that
the proposed merger and concurrent financing may not be completed
which may adversely affect the Company's business and the price of
its common stock, (ii) the failure to satisfy all of the
closing conditions of the proposed merger and concurrent financing,
including the adoption of the merger agreement by the Company's
stockholders, (iii) the occurrence of any event, change or
other circumstance that could give rise to the termination of the
merger agreement, (iv) the effect of the announcement or
pendency of the proposed merger and concurrent financing on the
Company's business and the price of its common stock,
(iv) risks related to the diverting of management's attention
from the Company's ongoing business operations, and (v) the
outcome of any legal proceedings that may be instituted against the
Company related to the merger agreement or the proposed merger.
Such risks, uncertainties and factors include, but are not
limited to the risks set forth in the Company's most recent Form
10-K, 10-Q and other SEC filings which are available through EDGAR
at www.sec.gov. The Company assumes no obligation to update the
forward-looking statements.
View original content with
multimedia:http://www.prnewswire.com/news-releases/tapimmune-and-marker-therapeutics-announce-entry-into-merger-agreement-creating-a-transformational-immuno-oncology-platform-300648328.html
SOURCE TapImmune Inc.