Expanding pipeline with addition of targeted
therapeutics to treat rare skeletal diseases, bone cancer and
injury
Strengthening leadership team with appointment
of Novosteo executives Dr. Dirk Thye as CEO and Dr. Karen Smith as
CMO of combined company
Planning corporate name change to Quince
Therapeutics to reflect broadening of therapeutic pipeline
Cortexyme, Inc. (Nasdaq: CRTX), a clinical-stage
biopharmaceutical company dedicated to improving the lives of
patients diagnosed with degenerative diseases, today announced that
it entered into an agreement under which the company plans to
acquire Novosteo, a privately-held biotech company focused on
targeted therapeutics to treat rare skeletal diseases, bone cancer
and injury. Upon completion of the transaction, Novosteo
stockholders will own approximately 15.5% of the combined company.
The transaction, which has been approved by the Boards of Directors
of both companies, is expected to close within the next 30
days.
David Lamond, chairman of Cortexyme’s Board of Directors, said,
“The acquisition of Novosteo adds a highly promising set of assets
and meaningfully expands the breadth of our management team. We
continue to review additional strategic actions that may
opportunistically build upon our growing rare and degenerative
disease focus. On behalf of Cortexyme’s Board, I would like to
thank Chris Lowe for his leadership as interim CEO and guiding us
through this acquisition.”
Dr. Dirk Thye, chief executive officer of Novosteo, commented,
“We have assembled a highly experienced and impressive team to
aggressively pursue the company’s next stage of growth. We intend
to capitalize on the combined assets of Novosteo and Cortexyme by
driving our therapeutic candidates through development, expanding
our targeted drug discovery platform, and pursuing new business
development opportunities.”
Pipeline Expansion with NOV004, a Precision Bone Growth
Molecule for Rare Disease
The acquisition of Novosteo expands Cortexyme’s drug development
pipeline into rare disease indications with the addition of NOV004,
a bone targeting molecule designed to accelerate fracture repair,
including in patients with osteogenesis imperfecta. Key highlights
of the compound include:
- NOV004 is engineered to specifically target and concentrate at
the bone fracture site, leading to higher concentrations of a
therapeutic anabolic peptide over longer periods of time directly
at the site of injury. This improved retention at the bone fracture
surface stimulates a robust healing response in preclinical
studies.
- In preclinical fracture studies, NOV004 increased new bone
production three-fold and resulted in bone that is almost twice as
dense as bone treated with a non-targeted therapeutic. At three
weeks post fracture, NOV004 treatment reached pre-fracture strength
and more than doubled control strength. Notably, these effects are
seen with normal physiology, as well as in osteogenesis imperfecta
– a rare bone disease caused by a congenital defect in the genetic
code for collagen.
- NOV004’s ability to increase bone production and stability
could result in significant mobility gain in distance and speed as
early as 12 days post-fracture in animal studies.
- With IND-enabling studies completed, NOV004 is expected to
enter Phase 1 clinical studies in 2023 and progress to a lead
indication in osteogenesis imperfecta.
Upon completion of the transaction, the company will have
capital resources of approximately $120 million in cash, cash
equivalents and investments as of March 31, 2022, on a proforma
basis with which to fund its combined operating requirements.
Leadership and Governance
Upon the close of the acquisition, the company will appoint
Novosteo executives Dr. Dirk Thye as chief executive officer, and
Dr. Karen Smith as chief medical officer of Cortexyme, adding
experienced leadership to support its next stage of growth. Dr.
Dirk Thye and Philip Low, PhD, a current director of Novosteo, will
also join the company’s Board of Directors upon close of the
transaction.
The company also plans to operate under a new name – Quince
Therapeutics, Inc. – and begin trading under the ticker symbol
"QNCX" in the coming months. At that time, the company will present
an overview of its pipeline development plans, clinical activity
updates, and anticipated milestones.
“The acquisition of Novosteo reflects the strategic expansion of
our pipeline, which remains focused on bringing innovative
therapeutics to diseases with high unmet clinical needs,” said
Chris Lowe, Cortexyme’s interim chief executive officer. “We are
excited about the addition of Novosteo’s targeted therapy platform
and extensive preclinical data to our expanding therapeutic
pipeline. I believe the appointments of Dr. Dirk Thye as CEO and
Dr. Karen Smith as CMO will bring exceptional expertise to lead the
company.”
Advisors
Cooley LLP acted as legal advisor to Cortexyme and Wilson
Sonsini Goodrich & Rosati acted as legal advisor to
Novosteo.
About Cortexyme
Cortexyme, Inc. (Nasdaq: CRTX) is a clinical stage
biopharmaceutical company dedicated to improving the lives of
patients diagnosed with rare and degenerative diseases. The
company’s innovative pipeline includes a precision bone growth
molecule and drug-targeting platform to treat rare skeletal
diseases, bone cancer and injury, in addition to small molecule
therapeutics targeting the infectious pathogen P. gingivalis’ role
in degenerative disease progression, including for indications such
as periodontal disease, oral potentially malignant disorders, and
Alzheimer’s disease, among others. To learn more about Cortexyme,
visit www.cortexyme.com or follow @Cortexyme on Twitter.
Forward-Looking Statements
Statements in this news release contain “forward-looking
statements” that are subject to substantial risks and
uncertainties. Forward-looking statements contained in this news
release may be identified by the use of words such as “believe,”
“expect,” intend,” “potential,” “will” or other similar words.
Examples of forward-looking statements include, among others, the
ability of the parties to consummate the proposed merger
transaction, satisfaction of closing conditions precedent to the
consummation of the proposed merger transaction, potential delays
in consummating the merger and the ability of Cortexyme to timely
and successfully achieve the anticipated benefits of the merger
transaction, cash sufficiency forecast, the strategic development
path for atuzaginstat and NOV004; its business plans, internal and
external development of the pipeline, strategy, planned FDA
submissions and clinical trials and timeline, prospects, and
milestone expectations; the timing and success of the company’s
clinical trials and related data, including plans and the ability
to initiate, conduct and/or complete current and additional
studies; the timing of announcements and updates relating to its
clinical trials and related data; the potential therapeutic
benefits, safety and efficacy of the combined company’s product
candidate or library of compounds; and statements about its ability
to obtain, and the timing relating to, further development of its
clinical candidates and other programs or indications, regulatory
submissions and interactions with regulators. Forward-looking
statements are based on Cortexyme’s current expectations and are
subject to inherent uncertainties, risks, and assumptions that are
difficult to predict and could cause actual results to differ
materially from what the company expects. Further, certain
forward-looking statements are based on assumptions as to future
events that may not prove to be accurate. Factors that could cause
actual results to differ include, but are not limited to, the risks
and uncertainties described in the section titled “Risk Factors” in
Cortexyme’s Annual Report on Form 10-K filed with the Securities
and Exchange Commission (SEC) on March 1, 2022, and other reports
as filed with the SEC. Forward-looking statements contained in this
news release are made as of this date, and Cortexyme undertakes no
duty to update such information except as required under applicable
law.
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version on businesswire.com: https://www.businesswire.com/news/home/20220510005477/en/
Cortexyme Contact: Stacy Roughan Cortexyme, Inc. Vice
President, Corporate Communications & Investor Relations
ir@cortexyme.com
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