SAN DIEGO & PRINCETON,
N.J., June 10, 2020
/PRNewswire/ -- DelMar Pharmaceuticals, Inc. (Nasdaq:
DMPI) ("DelMar") and Adgero Biopharmaceuticals Holdings, Inc.
("Adgero") today announced the companies have entered into a
definitive merger agreement pursuant to which DelMar, a
biopharmaceutical company focused on the development of new solid
tumor cancer therapies, will acquire Adgero, a privately held
biopharmaceutical company focused on the development of its late
stage photodynamic therapy platform for the treatment of serious
cutaneous oncology indications. In an all-equity transaction,
Adgero stockholders will receive shares of DelMar common
stock for shares of Adgero common stock.
Upon completion of the merger, current DelMar and Adgero
stockholders will own 50.5% and 49.5% of the total voting power of
the combined company, respectively, exclusive of securities to be
issued in a financing to occur prior to the merger closing, as well
as compensation payable in connection with the merger and the
financing. Subject to stockholder approval of both companies and
other closing conditions, the transaction is expected to close in
the third quarter of 2020, at which time DelMar is expected to
change its name to Kintara Therapeutics, Inc. and trade on Nasdaq
under the new ticker symbol "KTRA."
This combination brings together DelMar's first-in-class,
DNA-targeting chemotherapeutic with proven anti-cancer activities
with Adgero's photodynamic therapy platform. The combined
company expects to benefit from complementary
capabilities along with greater financial resources and
flexibility to engage in a wide range of research and development
activities that the companies believe will ultimately result in the
creation of sustainable long-term growth.
"The acquisition of Adgero by DelMar positions the combined
company for long-term corporate growth and increased shareholder
value by bringing together DelMar's oncology therapeutic candidate,
VAL-083, and Adgero's REM-001 photodynamic therapy with a lead
indication in CMBC," commented Saiid
Zarrabian, President and Chief Executive Officer of DelMar.
"This acquisition is the result of an extensive search for a
suitable oncology therapy and provides the combined company with a
diversified, late-stage oncology pipeline. During the next 12-18
months, we expect to achieve significant clinical milestones,
driven by a seasoned leadership team that will bolster our oncology
drug development expertise."
Mr. Zarrabian continued, "The clinical data from Adgero's
REM-001 has demonstrated significant anti-tumor efficacy to date,
with 80% complete responses reported across four studies in CMBC,
and we believe it will be a valuable late-stage pipeline complement
to DelMar's VAL-083 as we prepare for the GBM AGILE registration
study."
John Liatos, interim Chief
Executive Officer and Chief Financial Officer of Adgero,
added, "This combination provides us with the opportunity to not
only deepen our pipeline but also strengthen our oncology drug
development expertise and capabilities. Furthermore, our enthusiasm
to merge with DelMar was reinforced by the Global Coalition for
Adaptive Research's (GCAR) invitation to include VAL-083 in its GBM
AGILE pivotal study for the treatment of newly-diagnosed and
recurrent GBM. This is an important milestone with the
potential to greatly reduce VAL-083's development timeline and
speaks to the potential of VAL-083 given that only a limited number
of drug candidates will be invited to participate in the
study. On our end, we are tremendously proud of the progress
we have accomplished to date, and through this combination we look
forward to creating a highly focused oncology company that can
develop new therapies to help physicians and patients combat
cancers where current treatment options are limited."
Strategic Rationale for the Merger:
- Creates a diversified, late-stage oncology company with two
Phase 3-ready products that target rare, unmet medical needs in
oncology;
- Combined robust development efforts to date with an estimated
$300 million invested in the
development of DelMar's VAL-083 and Adgero's REM-001, both of which
have demonstrated anti-tumor activity in clinical trials and
possess a large patient safety database;
- Potential future pipeline expansion opportunities with an
existing Orphan designation and an approved IND in ovarian cancer,
and existing Orphan designations in basal cell carcinoma nevus
syndrome and hemodialysis grafts; and
- Bolstered oncology drug development expertise by the
combination of DelMar and Adgero leadership is instrumental for the
further clinical development of VAL-083 and REM-001.
Anticipated Late-stage Clinical Milestones Over the Next
12-18 Months*:
- Report at various oncology meetings, including the American
Association for Cancer Research Virtual Annual Meeting II being
held June 22-24, 2020;
- Top-line results from VAL-083's Phase 2 study in
newly-diagnosed GBM;
- Top-line results from VAL-083's Phase 2 study conducted at the
MD Andersen Cancer Center in recurrent GBM;
- Top-line results from VAL-083's Phase 2 study conducted at the
MD Andersen Cancer Center in adjuvant GBM;
- Initiation of patient enrollment into the VAL-083 arm of the
Global Coalition for Adaptive Research's GBM AGILE registrational
study in newly-diagnosed and recurrent GBM patients; and
- REM-001 confirmatory trial results in CMBC
*(subject to financing proceeds available to the combined
company)
Organizational Structure
Following the close of the transaction, Saiid Zarrabian, DelMar's President
and Chief Executive Officer, will continue to serve as
President and Chief Executive Officer, John
Liatos, Adgero's interim Chief Executive
Officer and Chief Financial Officer, will serve as Senior Vice
President, Business Development, Scott
Praill, DelMar's Chief Financial Officer, and
Dennis Brown, DelMar's Chief
Scientific Officer, will each continue to serve in
their respective capacities, and Steve
Rychnovsky, Adgero's Vice President, Operations and Product
Development will serve as Vice President, Research and
Development.
The combined Company's Board of Directors will consist of
seven directors, four of which will be
designated by DelMar, two of which will be nominated
by Adgero and approved by DelMar, and the remaining Director will
be mutually agreed upon by DelMar and Adgero.
Merger Process Overview and Financial
Rationale
Each outstanding share of Adgero common stock will be converted
into shares of DelMar common stock at an exchange ratio such that
current DelMar and Adgero stockholders will own 50.5% and
49.5% of the total voting power of the combined company,
respectively (the "Exchange Ratio"), upon completion of the
merger and exclusive of (i) securities to be issued in a financing
to occur prior to the merger closing and (ii) compensation payable
in connection with the merger and the financing. Each of the
1,470,092 outstanding warrants to purchase Adgero's common stock
will be exchanged for a warrant to purchase DelMar common stock as
calculated based on the Exchange Ratio, resulting in a total of
2,299,036 additional DelMar warrants outstanding. Each outstanding
Adgero stock option, whether vested or unvested, that has not been
exercised will be cancelled for no consideration as it is
anticipated that none of the options will be in-the money at the
time of the merger.
The transaction has been unanimously approved by the
Boards of Directors of DelMar and Adgero. The transaction is
subject to customary closing conditions, including, among
others, approval by the stockholders of each company, the
closing on a minimum $10 million
financing, and DelMar's continued listing on the Nasdaq
Capital Market, and is expected to close in third quarter of 2020.
Additionally, the transaction has the support from each of the
directors and executive officers of DelMar and Adgero.
Lowenstein Sandler LLP acted as external legal counsel to
DelMar and Ladenburg Thalmann & Co. Inc. provided a
fairness opinion to DelMar. Gracin & Marlow,
LLP acted as external legal counsel to Adgero.
About DelMar
Located in San Diego,
California, DelMar is focused on the development and
commercialization of new therapies for cancer patients who have
limited or no treatment options. By focusing on understanding tumor
biology and mechanisms of treatment resistance, DelMar identifies
biomarkers to personalize new therapies in indications where
patients are failing, or are unable to tolerate, standard-of-care
treatments.
DelMar's current pipeline is based around VAL-083, a
"first-in-class", small-molecule chemotherapeutic with a novel
mechanism of action that has demonstrated clinical activity against
a range of cancers, including central nervous system, ovarian and
other solid tumors (e.g. NSCLC, bladder cancer, head and neck) in
U.S. clinical trials sponsored by the National Cancer Institute
(NCI). Based on DelMar's internal research programs and these prior
NCI-sponsored clinical studies, DelMar is conducting clinical
trials to support the development and commercialization of VAL-083
to solve significant unmet medical needs.
VAL-083 is being studied in two collaborator-supported,
biomarker-driven Phase 2 clinical trials for MGMT-unmethylated GBM.
Overcoming MGMT-mediated resistance represents a significant unmet
medical need in the treatment of GBM. In addition, DelMar has
announced the allowance of a separate IND for VAL-083 as a
potential treatment for platinum-resistant ovarian cancer.
About Adgero
Adgero Biopharmaceuticals Holdings, Inc. is a biopharmaceutical
company focused on building a pipeline by advancing its proprietary
late stage photodynamic therapy ("PDT") platform that holds promise
as a localized cutaneous or visceral tumor treatment. Additionally,
PDT has immune activating properties and has potential therapeutic
utility in oncology as a combination therapy in conjunction with
immunotherapies. It is also being investigated in the
cardiovascular setting as treatment for hemodialysis access
failure. Adgero's lead product candidate, REM-001 therapy, has been
previously studied in four Phase 2/3 clinical trials in patients
with cutaneous metastatic breast cancer (CMBC), who had previously
received chemotherapy and/or failed radiation therapy. With
clinical efficacy to date of 80% complete responses of CMBC
evaluable lesions and with an existing robust safety database of
approximately 1,100 patients across multiple indications, Adgero is
currently focused on advancing the REM-001 program to late stage
pivotal testing.
Forward-Looking Statements
This press release contains forward-looking statements based
upon DelMar's and Adgero's current expectations. This communication
contains "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements are identified by terminology such as "may," "should,"
"expects," "plans," "anticipates," "could," "intends," "target,"
"projects," "contemplates," "believes," "estimates," "predicts,"
"potential" or "continue" or the negative of these terms or other
similar words. These statements are only predictions. DelMar and
Adgero have based these forward-looking statements largely on their
then-current expectations and projections about future events, as
well as the beliefs and assumptions of management. Forward-looking
statements are subject to a number of risks and uncertainties, many
of which involve factors or circumstances that are beyond each of
DelMar's and Adgero's control, and actual results could differ
materially from those stated or implied in forward-looking
statements due to a number of factors, including but not limited
to: (i) risks associated with DelMar's and Adgero's ability to
obtain the stockholder approval required to consummate the proposed
merger transaction and the timing of the closing of the proposed
merger transaction, including the risks that a condition to closing
would not be satisfied within the expected timeframe or at all or
that the closing of the proposed merger transaction will not occur;
(ii) the outcome of any legal proceedings that may be instituted
against the parties and others related to the merger agreement;
(iii) the occurrence of any event, change or other circumstance or
condition that could give rise to the termination of the merger
agreement, (iv) unanticipated difficulties or expenditures relating
to the proposed merger transaction, the response of business
partners and competitors to the announcement of the proposed merger
transaction, and/or potential difficulties in employee retention as
a result of the announcement and pendency of the proposed merger
transaction; (v) whether the combined business of Adgero and DelMar
will be successful, and (vi) those risks detailed in DelMar's most
recent Annual Report on Form 10-K and subsequent reports filed with
the SEC, as well as other documents that may be filed by DelMar
from time to time with the SEC. Accordingly, you should not rely
upon forward-looking statements as predictions of future events.
Neither DelMar nor Adgero can assure you that the events and
circumstances reflected in the forward-looking statements will be
achieved or occur, and actual results could differ materially from
those projected in the forward-looking statements. The
forward-looking statements made in this communication relate only
to events as of the date on which the statements are made. Except
as required by applicable law or regulation, DelMar and Adgero
undertake no obligation to update any forward-looking statement to
reflect events or circumstances after the date on which the
statement is made or to reflect the occurrence of unanticipated
events. Investors should not assume that any lack of update
to a previously issued "forward-looking statement" constitutes a
reaffirmation of that statement.
Additional Information and Where to Find It
This press release is for informational purposes only and does
not constitute an offer to buy or sell or the solicitation of an
offer to buy or sell any securities or a solicitation of any vote
or approval. This press release relates to the proposed merger of
DelMar and Adgero. In connection with the proposed merger,
DelMar will file a registration statement on Form S-4, which
will include a document that serves as a prospectus and proxy
statement of DelMar (the "proxy statement/prospectus"),
and DelMar will file other documents regarding the proposed
merger transaction with the U.S. Securities and Exchange Commission
(the "SEC"). No offering of securities shall be made, except by
means of a prospectus meeting the requirements of Section 10 of the
U.S. Securities Act of 1933, as amended. INVESTORS AND SECURITY
HOLDERS ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS AND OTHER
RELEVANT DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR
ENTIRETY, WHEN THEY BECOME AVAILABLE, BECAUSE THEY WILL CONTAIN
IMPORTANT INFORMATION THAT STOCKHOLDERS SHOULD CONSIDER BEFORE
MAKING ANY DECISION REGARDING THE PROPOSED MERGER. A definitive
proxy statement/prospectus will be sent to
DelMar's stockholders. Investors and security holders will be
able to obtain these documents (when available) free of charge from
the SEC's website at www.sec.gov. The documents filed by
DelMar with the SEC may also be obtained free of charge from
DelMar by requesting them by mail at DelMar Pharmaceuticals,
Inc., 12707 High Bluff Drive, Suite 200, San Diego, CA 92130.
Participants in the Solicitation
DelMar and its respective directors and executive officers
and other members of management and employees and certain of their
respective significant stockholders may be deemed to be
participants in the solicitation of proxies from DelMar
stockholders in respect of the proposed merger transaction.
Information about DelMar's directors and executive officers is
available in DelMar's proxy statement, filed June 2, 2020 for the 2020 Annual Meeting of
Stockholders, DelMar's Annual Report on Form 10-K for the
fiscal year ended June 30, 2019,
which was filed with the SEC on September 9, 2019 and DelMar's Current
Report on Form 8-K filed on September
9, 2019. Information regarding the persons who may,
under the rules of the SEC, be deemed participants in the proxy
solicitation and a description of their direct and indirect
interests, by security holding or otherwise, will be contained in
the proxy statement/prospectus and other relevant materials to be
filed with the SEC regarding the proposed merger transaction when
they become available. Investors should read the proxy
statement/prospectus carefully when it becomes available before
making any voting or investment decisions. You may obtain free
copies of these documents from the SEC and DelMar as indicated
above.
No Offer or Solicitation
This press release shall not constitute 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 shall be made except by means of a
prospectus meeting the requirements of Section 10 of the Securities
Act of 1933, as amended.
Contact Information
DelMar:
Investors:
CORE IR
516-222-2560
ir@coreir.com
Media:
Jules
Abraham
Director of Public Relations
CORE IR
917-885-7378
julesa@coreir.com
Adgero:
Jenene Thomas Communications
adgero@jtcir.com
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SOURCE DelMar Pharmaceuticals, Inc.
