Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX), a clinical-stage
biopharmaceutical company developing therapies for patients with
cancer in need of new treatment options, and Decoy Therapeutics,
Inc., a privately held preclinical biopharmaceutical company
engineering the next generation of peptide conjugate therapeutics,
announce the signing of a definitive agreement under which Decoy
Therapeutics will merge with a wholly-owned subsidiary of Salarius
Pharmaceuticals, subject to the closing conditions set forth in the
definitive agreement. The newly formed company will be named Decoy
Therapeutics.
This proposed transaction is expected to facilitate multiple
value-creating inflection points with Decoy’s pipeline of peptide
conjugate therapeutics engineered by its IMP3ACT platform, which
allows for the rapid computational design and manufacturing of
innovative peptide conjugate therapeutics including rapid response
to novel viral pathogens such as avian H5N1 flu. Decoy’s product
pipeline targets unmet needs in respiratory infectious diseases and
gastroenterology (GI) oncology indications.
In addition, the combined company intends to incorporate
Salarius’ oral small molecule protein degrader SP-3164 into a
highly targeted peptide-based proteolysis targeting chimeras
(PROTACS) drug candidate. The ongoing development of Salarius’
seclidemstat for hematologic cancers in an investigator-initiated
Phase 1/2 clinical trial at MD Anderson Cancer Center (MDACC) will
be supported while the company evaluates strategic alternatives for
seclidemstat.
Executive Leadership and Management
Commentary
The combined company will be led by Decoy’s Co-founders, Chief
Executive Officer Frederick “Rick” Pierce and Chief Scientific
Officer Barbara Hibner, by Decoy’s Chief Business Officer Peter
Marschel, Chief Technology Officer Mike Lipp and acting Chief
Medical Officer and Scientific Advisory Board Chair Shahin
Gharakhanian, M.D., and by Salarius’ Chief Financial Officer Mark
Rosenblum. The two companies have further agreed that upon closing
of the merger and a post-closing shareholder vote approving the
conversion of the preferred stock issued at closing, the newly
merged company’s Board of Directors will be comprised of Rick
Pierce and Barbara Hibner, and three independent Directors, two
appointed by Decoy’s Board and one by Salarius’ Board.
Rick Pierce is a life sciences executive with more than 25 years
of senior management experience across private and public
companies. Previously he served as Vice President of Corporate
Development and Investor Relations at Javelin Pharmaceuticals, a
publicly traded company that developed Dyloject™ through EMEA
approval, launch and NDA submission, at which time it was acquired
by Hospira, Inc., now a subsidiary of Pfizer. Earlier in his
career, Mr. Pierce spent 15 years in investment banking at bulge
bracket Wall Street firms primarily focused on corporate finance,
institutional sales and trading in healthcare, biotechnology and
technology, ultra-high-net worth individuals and family
offices.
Mr. Pierce commented, “Peptide conjugates have become one of the
most important drug classes as measured by prescription rates and
revenue growth. Our highly experienced team is excited to be able
to unlock significant shareholder value from our IMP3ACT platform,
which can rapidly design new peptide conjugate drugs by applying ML
and AI tools. Having access to capital and the visibility afforded
by a public listing are significant corporate milestones that
further enable Decoy to advance our expanded preclinical and
clinical candidates to address important unmet patient needs.”
"After undertaking a comprehensive strategic review process, we
believe that the proposed transaction with Decoy Therapeutics
offers the best opportunity to create significant near- and
long-term value,” stated David Arthur, President, CEO and Director
of Salarius Pharmaceuticals. “The compelling science supporting
Decoy’s peptide conjugate technology and the company’s management
team are truly impressive. Based on our diligence, we believe Decoy
is poised to advance multiple drug candidates that address
significant unmet needs in numerous therapeutic areas. The Board of
Salarius and I would like to thank our stockholders for their
support during this review process, and to reiterate the team’s
commitment to enhancing shareholder value with this transaction and
beyond.”
Upcoming Milestones
During the next 12 months, Decoy expects to advance its lead
asset, a pan-coronavirus antiviral, to the filing of an
Investigational New Drug (IND) application with the U.S. Food and
Drug Administration (FDA), and to make progress with its other
programs including a broad-acting antiviral against flu, COVID-19
and respiratory syncytial virus (RSV), and a peptide drug conjugate
targeting GI cancers.
Also during this time data may be reported from the ongoing
MDACC clinical trial in myelodysplastic syndrome (MDS) and chronic
myelomonocytic leukemia (CMML) patients who previously failed or
relapsed after hypomethylating agent therapy.
About the Proposed Transaction
Definitive agreements were executed with unanimous approvals by
the Boards of Directors of Salarius Pharmaceuticals and Decoy
Therapeutics. The closing consideration will consist primarily of
nonvoting preferred stock of Salarius, and it is expected that
following closing and a post-closing stockholder vote to approve
the conversion of the preferred shares into common stock, Decoy
investors would own approximately 86% of the outstanding shares of
the merged company and Salarius stockholders would own
approximately 14% of the outstanding shares, subject to adjustment,
in each case exclusive of any shares issued in any subsequent
financing. For further details on the transaction and conditions
for closing of the merger, please refer to the Form 8-K Salarius
Pharmaceuticals filed with the U.S. Securities and Exchange
Commission (SEC) in conjunction with this press release at
www.sec.gov.
Canaccord Genuity is serving as exclusive strategic advisor to
Salarius, and Hogan Lovells US LLP and Honigman LLP are serving as
legal counsel. Ladenburg Thalmann is serving as financial advisor
to Decoy, and Nason, Yeager, Gerson, Harris & Fumero, P.A. is
serving as legal counsel.
About Decoy Therapeutics, Inc.
Decoy Therapeutics is a preclinical-stage biotechnology company
that is leveraging machine learning and artificial intelligence
tools alongside high-speed synthesis techniques to rapidly design,
engineer and manufacture peptide conjugate drug candidates that
target serious unmet medical needs. The company’s initial pipeline
is focused on respiratory viruses and GI cancers. Decoy has
attracted financing from institutional investors as well as
significant non-dilutive capital from the Bill & Melinda Gates
Foundation, the Massachusetts Life Sciences Seed Fund, the Google
AI startup program and the NVIDIA Inception program. The company
has also received QuickFire Challenge award funding provided by
BARDA through BLUE KNIGHT™, a collaboration between Johnson &
Johnson Innovation – JLABS and the Biomedical Advanced Research and
Development Authority within the Administration for Strategic
Preparedness and Response. For more information, please visit
www.DecoyTx.com.
About Salarius Pharmaceuticals, Inc.
Salarius Pharmaceuticals is a clinical-stage biopharmaceutical
company with two drug candidates for patients with cancer in need
of new treatment options. Salarius’ product portfolio includes
seclidemstat, the company’s lead candidate, which is being studied
in an investigator-initiated Phase 1/2 clinical study in
hematologic cancers underway at MD Anderson Cancer Center as a
potential treatment for MDS and CML in patients with limited
treatment options. SP-3164, the company’s IND-stage second asset,
is an oral small molecule protein degrader. Salarius previously
received financial support for seclidemstat for the treatment of
Ewing sarcoma from the National Pediatric Cancer Foundation
and was a recipient of a Product Development Award from
the Cancer Prevention and Research Institute of
Texas (CPRIT). For more information, please visit
www.salariuspharma.com.
Non-Solicitation
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 public offer of
securities in connection with the merger shall be made except by
means of a prospectus meeting the requirements of Section 10 of the
Securities Act of 1933, as amended.
Forward-Looking Statements This press release
contains forward-looking statements regarding Salarius, Decoy, the
proposed merger and other matters, including without limitation,
statements relating to the expected ownership percentages of the
combined company and plans and expectations relating to the
business, products including expected achievement of milestones for
its lead asset and future prospects of Decoy and the combined
company. These statements may discuss goals, intentions and
expectations as to future plans, trends, events, results of
operations or financial condition, or otherwise, based on current
beliefs of the management of Salarius, as well as assumptions made
by, and information currently available to, management.
Forward-looking statements generally include statements that are
predictive in nature and depend upon or refer to future events or
conditions, and include words such as “may,” “will,” “should,”
“would,” “expect,” “anticipate,” “plan,” “likely,” “believe,”
“estimate,” “project,” “intend,” and other similar expressions.
Statements that are not historical facts are forward-looking
statements. Forward-looking statements are based on current beliefs
and assumptions that are subject to risks and uncertainties and are
not guarantees of future performance. Actual results could differ
materially from those contained in any forward-looking statement as
a result of various factors, including, without limitation: the
risk that the conditions to the Closing are not satisfied,
including uncertainties as to the timing of the consummation of the
proposed merger; the ability of each of Salarius and Decoy to
consummate the merger; risks related to Salarius’ ability to
estimate and manage its operating expenses and its expenses
associated with the proposed merger pending the closing; risks that
the combined company will not achieve the synergies expected from
the proposed merger; risks that Salarius and the combined company
will not obtain sufficient financing to execute on their business
plans and risks related to Decoy’s products and development plans
including unanticipated issues with any IND application process.
Readers are urged to carefully review and consider the various
disclosures made by us in our reports filed with the SEC, including
the risk factors contained in Salarius’ Current Report on Form 8-K
filed on January 13, 2025 which attempt to advise interested
parties of the risks and factors that may affect the merger, and
the prospects, financial condition, results of operation and cash
flows of each of Salarius, Decoy and the combined company. If one
or more of these risks or uncertainties materialize, or if the
underlying assumptions prove incorrect, our actual results may vary
materially from those expected or projected.
CONTACTS:
Salarius Pharmaceuticals, Inc.
Alliance Advisors IRJody
Cainjcain@allianceadvisors.com310-691-7100
Decoy Therapeutics, Inc.
Investors and Media:Rick Pierce,
CEOPierce@decoytx.com617-447-8299
Business Development:Peter Marschel,
CBOPeter@Decoytx.com617-943-6305
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