Acquisition includes lead clinical-stage
compound AT-1501, a next generation anti-CD40L antibody, in
development for organ and cellular transplantation, autoimmune
diseases, and neurodegenerative diseases
Senior management team with extensive drug
development and commercialization experience, including Dr.
David-Alexandre “DA” C. Gros as CEO and Dr. Steven Perrin as
President and CSO, to lead Novus
Company completes private placement financing
with proceeds of $108 million to be used to advance AT-1501 Phase 2
clinical trials in up to four indications
Conference call tomorrow at 8:30 a.m. EDT
Novus Therapeutics, Inc. (“Novus”) (NASDAQ: NVUS) today
announced it has completed the acquisition of Anelixis
Therapeutics, Inc. (“Anelixis”), a privately held clinical stage
biotechnology company developing a next generation anti-CD40 Ligand
(CD40L) antibody as a potential treatment for organ and cellular
transplantation, autoimmune diseases, and neurodegenerative
diseases. Concurrent with the acquisition of Anelixis, Novus
entered into a definitive agreement for the sale of non-voting
convertible preferred stock (the “Preferred Stock”) in a private
placement to a group of institutional accredited investors led by
BVF Partners L.P., with participation from Cormorant Asset
Management, Ecor1 Capital, Logos Capital, Fidelity Management and
Research Company, Adage Capital Partners L.P., Woodline Partners
LP, Ridgeback Capital, Janus Henderson Investors, and Samsara
BioCapital, as well as additional investors. The private placement
is expected to result in gross proceeds to Novus of approximately
$108 million before deducting placement agent and other offering
expenses. The proceeds from the private placement will be used to
fund the Company’s operations, including to advance Phase 2
clinical trials of AT-1501, a humanized IgG1 anti-CD40L antibody
with high affinity for CD40L, in renal transplantation, islet cell
transplantation, autoimmune nephritis, and amyotrophic lateral
sclerosis (ALS).
“We are excited about AT-1501 and the potential to develop and
commercialize the next generation anti-CD40L antibody, a
well-validated target with broad therapeutic possibilities,” said
Keith A. Katkin, Chairman of the Board of Directors of Novus.
“After exploring a range of strategic options to maximize
shareholder value, we believe this acquisition represents the
greatest value creation opportunity for Novus stockholders, and we
are confident that we have the management and scientific leadership
team to fully realize this opportunity for patients in need of new
treatment options.”
Leadership & Organization
In addition to the strategic acquisition and private placement,
Novus announced its Board of Directors has previously appointed
David-Alexandre “DA” C. Gros, M.D. to serve as Chief Executive
Officer and Director. Dr. Gros joins Novus from Imbria
Pharmaceuticals Inc., where he served as Co-Founder, Chief
Executive Officer and Director. Prior to Imbria, Dr. Gros was
President and Chief Operating Officer of Neurocrine Biosciences,
Inc., Chief Business and Principal Financial Officer of Alnylam
Pharmaceuticals, Inc., and Chief Strategy Officer of Sanofi, S.A.
Before Sanofi, Dr. Gros held leadership positions in healthcare
investment banking at Centerview Partners, LLC, and Merrill Lynch,
Pierce, Fenner & Smith, Inc., and in healthcare consulting at
McKinsey & Company. Dr. Gros earned a Doctor of Medicine from
Johns Hopkins University School of Medicine, a Master of Business
Administration from Harvard Business School, and a Bachelor of Arts
from Dartmouth College.
“I am both thrilled and humbled to join the Novus management
team and Board during this new phase of the company’s evolution, as
we prepare to initiate multiple Phase 2 trials for AT-1501” said
Dr. Gros. “Through this acquisition and financing, we now have the
scientific, organizational and financial resources to build upon a
deep historical understanding of the CD40/CD40L pathway, as well as
Anelixis’ preclinical and Phase 1 data, to address the needs of
people undergoing organ or cellular transplantation, or living with
autoimmune and neurodegenerative diseases.”
Joining Dr. Gros on the Novus management team and Board of
Directors is Steven Perrin, Ph.D., Founder and Chief Executive
Officer of Anelixis, who will take on the role of President and
Chief Scientific Officer. Dr. Perrin brings 20 years of drug
development experience to Novus, having held R&D positions at
the Hoechst-Ariad Genomics Center, Aventis Pharmaceuticals, Inc.,
and Biogen Idec, Inc. Over the past decade, Dr. Perrin has worked
with the ALS Therapy Development Institute to develop the world’s
largest ALS drug development program, bridging preclinical and
clinical programs. Dr. Perrin received a Ph.D. in biochemistry from
Boston University Medical Center, where he also started his career
as Associate Professor of Medicine, and a Bachelor of Science from
Boston College.
“The activation of CD40/CD40L signaling is critical to mediating
antibody and cellular inflammatory response. We are developing
antibodies to inhibit the activation of this pathway with the hope
of offering new treatment modalities for people living with
conditions such as autoimmune nephritis and ALS, or those requiring
a potentially life-saving transplant,” said Dr. Perrin. “I have
dedicated my career to developing better medicines for these
patients and their families, and I look forward to working with the
team to advance these clinical programs.”
Concurrent with the acquisition, former Anelixis Chairman of the
Board Walter Ogier has been appointed to the Novus Board of
Directors. Mr. Ogier has more than 30 years of experience
developing therapeutic medical products ranging from
pharmaceuticals to medical devices, stem and immune cell therapies,
and gene therapies. He has served in multiple CEO roles including
Genetix Pharmaceuticals, Inc. (now bluebird bio, Inc.) and Acetylon
Pharmaceuticals, Inc., which Celgene Corporation acquired in 2016.
In addition to Novus, he serves as a director of Biothera
Pharmaceuticals, Inc., Thetis Pharmaceuticals, LLC, and Nemucore
Medical Innovations, Inc., and as Board advisor to Kodikaz
Therapeutic Solutions, Inc., and ME Therapeutics, Inc.
Novus Board members will also include Keith A. Katkin, Chairman
of the Board; Gary A. Lyons; and John S. McBride. The company will
continue to maintain its executive offices in Irvine, Calif. and
will have research and development facilities in Boston, Mass.
About the Transactions
The acquisition of Anelixis was structured as a stock-for-stock
transaction whereby all of Anelixis’ outstanding equity interests
were exchanged in a merger for a combination of shares of Novus
common stock and shares of Preferred Stock. Concurrently with the
acquisition of Anelixis, Novus entered into definitive agreements
for a PIPE investment with existing and new investors to raise
approximately $108 million in which the investors will be issued
shares of Preferred Stock at a price of approximately $500 per
share (or, $0.50 per share on an as-converted-to-common basis). The
PIPE offering is expected to close on September 14, 2020. Subject
to stockholder approval, each share of Preferred Stock will, at the
option of the holder, be convertible into 1,000 shares of common
stock, subject to certain beneficial ownership limitations set by
each holder. The acquisition was approved by the Board of Directors
of Novus and the equity holders of Anelixis.
Ladenburg Thalmann & Co. Inc. is serving as exclusive
financial advisor and Gibson, Dunn & Crutcher LLP is serving as
legal counsel to Novus. Goodwin Procter LLP is serving as legal
counsel to Anelixis. SVB Leerink is serving as financial advisor
and lead placement agent for the private placement, and Noble Life
Science Partners, a division of Noble Capital Markets, Inc., is
acting as co-placement agent.
Additional details are available in an updated corporate
presentation that can be found online at www.novustherapeutics.com.
Webcast Details
Novus will host an audio webcast on Tuesday, September 15, 2020,
at 8:30 a.m. EDT to discuss the acquisition. The live audio webcast
will be accessible through a direct link and the investor section
of www.novustherapeutics.com. To access via phone, please dial
(833) 614-1390 (toll-free) or (914) 987-7111 (international) and
provide the conference ID 4046285. Please visit the investor
section of the Novus website at www.novustherapeutics.com for the
archived webcast and for more information on the acquisition.
About AT-1501
AT-1501 is a humanized IgG1 anti-CD40L antibody with high
affinity for CD40L, a well-validated target with broad therapeutic
potential. The CD40/CD40L pathway plays a central role in
generating pro-inflammatory responses in autoimmune disease,
allograft transplant rejection, and neuroinflammation. In a Phase 1
safety study of healthy volunteers and patients with ALS, AT-1501
was well tolerated at all doses tested.
About Novus Therapeutics
Novus Therapeutics, Inc. is a clinical stage biotechnology
company using its expertise in targeting the CD40L pathway to
develop potential treatments for people requiring an organ or
cell-based transplant, and for people with autoimmune and
neurodegenerative disease. Novus is headquartered in Irvine, Calif.
For more information, please visit the company’s website at
www.novustherapeutics.com.
Follow Novus Therapeutics on social media: @Novus_Thera and
LinkedIn.
Notice of Issuance of Inducement Grants
Pursuant to their employment agreements, Drs. Gros and Perrin
have been awarded options to purchase a total of 18,279 and 7,857
shares of Preferred Stock, respectively, subject to time-based
vesting (the "Inducement Grants"). The Inducement Grants have an
exercise price of $500 per share of Preferred Stock, which is equal
to the price at which the Preferred Stock is being offered and sold
in the PIPE financing and represents (on an as-converted basis) a
premium of approximately 30% over the last reported closing price
of the Novus common stock prior to grant. The Inducement Grants
have been approved by the Novus Board of Directors and the
Compensation Committee of the Board of Directors. The Inducement
Grants will be issued outside of the Company's stockholder-approved
equity incentive plans as an inducement grant in accordance with
Nasdaq Listing Rule 5635(c)(4).
Forward-Looking Statements
This press release contains forward-looking statements that
involves substantial risks and uncertainties. Any statements about
the company’s future expectations, plans and prospects, including
statements about its strategy, future operations, development of
its product candidates, and other statements containing the words
“believes,” “anticipates,” “plans,” “expects,” “estimates,”
“intends,” “predicts,” “projects,” “targets,” “looks forward,”
“could,” “may,” and similar expressions, constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, although not all forward-looking statements
include such identifying words. Forward-looking statements include,
but are not limited to statements regarding: risks related to
market conditions; expectations regarding the timing for the
commencement of future clinical trials; expectations regarding the
success of clinical trials; the rate and degree of market
acceptance and clinical utility of the company’s products; the
company’s estimates regarding expenses and cash runway; and the
impact of the ongoing coronavirus pandemic. Actual results may
differ materially from those indicated by such forward-looking
statements as a result of various factors. These risks and
uncertainties, as well as other risks and uncertainties that could
cause the company’s actual results to differ significantly from the
forward-looking statements contained herein, are discussed in our
quarterly 10-Q, annual 10-K, and other filings with the SEC, which
can be found at www.sec.gov. Any forward-looking statements
contained in this press release speak only as of the date hereof
and not of any future date, and the company expressly disclaims any
intent to update any forward-looking statements, whether as a
result of new information, future events or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20200914005852/en/
Amanda Sellers asellers@vergescientific.com 301.332.5574
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