AUM Biosciences Pte. Ltd. (“AUM”), a global clinical-stage biotech
company focused on discovering and developing precision oncology
therapeutics, announced today that the U.S. Food and Drug
Administration (“FDA”) has granted Orphan Drug Designation for
AUM302, a potential first-in-class oral kinase inhibitor that
targets not only PI3K, but also key resistance mechanisms such as
PIM and mTOR, for the treatment of neuroblastoma.
“The Orphan Drug Designation for AUM302 is the
second Orphan Drug Designation we have received for our products
this year, marking a significant milestone for AUM as we advance
our diverse pipeline of precision oncology therapeutics designed to
reverse cancer resistance,” said Vishal Doshi, Founder and CEO of
AUM. “AUM302 has the potential to be the first-in-class
multi-kinase inhibitor for treatment of neuroblastoma. The FDA
decision reinforces the strength of our drug development strategy
and clinical trial design to deliver affordable, safe, and
effective oncology treatments.”
Preclinical studies of AUM302 have indicated
that complementing conventional chemotherapy treatment with
PIM/PI3K/mTOR inhibition has the potential to improve clinical
outcomes in children with high-risk neuroblastoma as well as
inhibit cancer cell growth, and prevent resistance emergence.
"Despite progress in understanding drug
resistance over the last decade, knowledge gaps remain about the
underlying biological causes of drug resistance and the design of
cancer treatments to overcome it,” continued Mr. Doshi. “Our goal
is to reverse cancer resistance with a broad portfolio of
cost-effective therapies.”
Orphan Drug Designation status is granted by the
FDA’s Office of Orphan Products Development to drug and biologic
candidates that are intended for the treatment, diagnosis or
prevention of rare diseases, meaning conditions that affect fewer
than 200,000 people in the U.S. Orphan Drug Designation provides
certain benefits, including financial incentives, to support
clinical development and the potential for up to seven years of
market exclusivity for the drug for the designated orphan
indication in the U.S. if the drug is ultimately approved for its
designated indication.
On October 20, 2022, AUM and Mountain Crest
Acquisition Corp. V (Nasdaq: MCAG) (“Mountain Crest”), a publicly
traded special purpose acquisition company formed in Delaware,
whose management team has an impressive pedigree of successful SPAC
transactions, announced that they have entered into a definitive
business combination agreement (the “Agreement”). Upon closing of
the transaction, the combined company will operate under a holding
entity, AUM Biosciences Limited, a Cayman Islands exempted company
(“Holdco”), and intends to trade on the Nasdaq Stock Market under
the ticker symbol AUMB.
About AUM302AUM302 is a
potential first-in-class oral kinase inhibitor rationally designed
to uniquely combine pan-PIM kinase, pan-PI3K and mTOR inhibition in
a single agent. This multi-targeting approach has been engineered
into a single molecule that has the potential to inhibit multiple
key intracellular pathways, increasing its ability to inhibit
cancer cell growth and prevent resistance emergence. In early
studies to date, AUM302 has shown promise with good tolerability
and favourable drug properties. AUM302 is a unique multi-targeted
cancer therapeutic that targets not only PI3K, but also key
resistance mechanisms such as PIM and mTOR. AUM302 is a single
molecule therapeutic designed to optimize inhibition of these key
pathways.
About AUM Biosciences AUM is a
global clinical-stage oncology company focused on advancing a
pipeline of precision oncology therapeutics designed to deploy
multi-faceted inhibition strategies to reverse cancer resistance.
AUM is advancing a broad portfolio of precision oncology
therapeutics. AUM001 is a selective and synergistic MNK inhibitor
as shown in current studies and expected to begin Phase 2 enrolment
in the fourth quarter 2022. AUM601 is a promising therapy for
tropomyosin receptor kinase (TRK) fusions and mutations within the
kinase domain and is on track to enter Phase 2 planning. AUM302 is
a potentially first-in-class macrocyclic oral kinase inhibitor
rationally designed small molecule to uniquely combine pan-PIM
kinase, pan-PI3K and mTOR inhibition in a single agent. Comprised
of industry veterans with decades of research and development
experience, the AUM leadership has an extensive track record of
selecting distinctive early-stage assets, successfully exiting
virtual biotech models, and has contributed to over 50 INDs and
over 150 oncology clinical trials, and development of several
currently marketed oncology treatments with annual peak sales up to
$3 billion.
About Mountain CrestMountain
Crest Acquisition Corp. V (Nasdaq: MCAG) is a blank check company
formed for the purpose of effecting a merger, share exchange, asset
acquisition, share purchase, reorganization or similar business
combination with one or more businesses.
Non-SolicitationThis press
release shall not constitute a solicitation of a proxy, consent, or
authorization with respect to any securities or in respect of the
proposed business combination. This press release shall also 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
states or jurisdictions 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, or an exemption therefrom.
Important Information About the Proposed
Business Combination and Where to Find ItIn connection
with the proposed business combination, AUM, Mountain Crest and/or
a successor entity of the transaction intends to file relevant
materials with the SEC, including a registration statement on Form
F-4 containing a proxy statement/prospectus (the “Registration
Statement”). The Registration Statement will include a proxy
statement/prospectus to be distributed to holders of Mountain
Crest’s common stock in connection with Mountain Crest’s
solicitation of proxies for the vote by Mountain Crest’s
stockholders with respect to the proposed transaction and other
matters as described in the Registration Statement, as well as the
prospectus relating to the offer of securities to be issued to
AUM’s stockholders in connection with the proposed business
combination. After the Registration Statement has been filed and
declared effective, Mountain Crest will mail a definitive proxy
statement, when available, to its stockholders. Copies of these
documents may be obtained free of charge at the SEC's website at
www.sec.gov. Stockholders of Mountain Crest are urged to read the
Registration Statement and the other relevant materials when they
become available before making any voting decision with respect to
the proposed business combination because they will contain
important information. The information contained on, or that may be
accessed through, the website referenced in this press release is
not incorporated by reference into, and is not a part of, this
press release.
Participants in the
SolicitationMountain Crest and its directors and executive
officers may be deemed participants in the solicitation of proxies
from Mountain Crest’s stockholders with respect to the business
combination. A list of the names of those directors and executive
officers and a description of their interests in Mountain Crest
will be included in the Registration Statement for the proposed
business combination and be available at www.sec.gov. Additional
information regarding the interests of such participants will be
contained in the Registration Statement for the proposed business
combination when available. Information about Mountain Crest’s
directors and executive officers and their ownership of Mountain
Crest common stock is set forth in Mountain Crest’s Annual Report
on Form 10-K for the fiscal year ended December 31, 2021, as
modified or supplemented by any Form 3 or Form 4 filed with the SEC
since the date of such filing. Other information regarding the
interests of the participants in the proxy solicitation will be
included in the Registration Statement pertaining to the proposed
business combination when it becomes available. These documents can
be obtained free of charge from the sources indicated above.
AUM and its directors and executive officers may
also be deemed to be participants in the solicitation of proxies
from the stockholders of Mountain Crest in connection with the
proposed business combination. A list of the names of such
directors and executive officers and information regarding their
interests in the proposed business combination will be included in
the Registration Statement for the proposed business
combination.
Forward-Looking StatementsThis
press release includes “forward-looking statements” within the
meaning of the “safe harbor” provisions of the United States
Private Securities Litigation Reform Act of 1995. Mountain Crest’s
and AUM’s actual results may differ from their expectations,
estimates, and projections and, consequently, you should not rely
on these forward-looking statements as predictions of future
events. Words such as “expect,” “estimate,” “project,” “budget,”
“forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,”
“should,” “believes,” “predicts,” “potential,” “continue,” and
similar expressions (or the negative versions of such words or
expressions) are intended to identify such forward-looking
statements. These forward-looking statements include, without
limitation, Mountain Crest’s and AUM’s expectations with respect to
future performance and anticipated financial impacts of the
proposed business combination, the satisfaction of the closing
conditions to the proposed business combination, and the timing of
the completion of the proposed business combination.
These forward-looking statements involve
significant risks and uncertainties that could cause the actual
results to differ materially from those discussed in the
forward-looking statements. Most of these factors are outside
Mountain Crest’s and AUM’s control and are difficult to predict.
Factors that may cause such differences include, but are not
limited to: (1) the occurrence of any event, change, or other
circumstances that could give rise to the termination of the
Agreement; (2) the outcome of any legal proceedings that may be
instituted against Mountain Crest and AUM following the
announcement of the Agreement and the transactions contemplated
therein; (3) the inability to complete the proposed business
combination, including due to failure to obtain approval of the
stockholders of Mountain Crest and AUM, certain regulatory
approvals, or satisfy other conditions to closing in the Agreement;
(4) the occurrence of any event, change, or other circumstance that
could give rise to the termination of the Agreement or could
otherwise cause the transaction to fail to close; (5) the impact of
the COVID-19 pandemic on AUM’s business and/or the ability of the
parties to complete the proposed business combination; (6) the
inability to obtain the listing of Holdco’s ordinary shares on
Nasdaq following the proposed business combination; (7) the risk
that the proposed business combination disrupts current plans and
operations as a result of the announcement and consummation of the
proposed business combination; (8) the ability to recognize the
anticipated benefits of the proposed business combination, which
may be affected by, among other things, competition, the ability of
AUM to grow and manage growth profitably, and retain its key
employees; (9) costs related to the proposed business combination;
(10) changes in applicable laws or regulations; (11) the
possibility that Mountain Crest or AUM may be adversely affected by
other economic, business, and/or competitive factors; (12) risks
relating to the uncertainty of the projected financial information
with respect to AUM; (13) risks related to the organic and
inorganic growth of AUM’s business and the timing of expected
business milestones, including but not limited to the safety and/or
efficacy of AUM302, or AUM’s inability to obtain regulatory
approval of any product; (14) the amount of redemption requests
made by Mountain Crest’s stockholders; and (15) other risks and
uncertainties indicated from time to time in the final prospectus
of Mountain Crest for its initial public offering and the
Registration Statement relating to the proposed business
combination, including those under “Risk Factors” therein, and in
Mountain Crest’s other filings with the SEC. Mountain Crest
cautions that the foregoing list of factors is not exclusive.
Mountain Crest and AUM caution readers not to place undue reliance
upon any forward-looking statements, which speak only as of the
date made. Mountain Crest and AUM do not undertake or accept any
obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements to reflect any change
in their expectations or any change in events, conditions, or
circumstances on which any such statement is based.
Contacts:For AUM Biosciences
Pte. Ltd.:Mr. Vishal DoshiCEO10 Anson Road, 24-16 A/B, Singapore,
079903
Investors:ICR
WestwickeStephanie CarringtonT: (646)
277-1282stephanie.carrington@westwicke.com
Media:FINN PartnersGlenn
SilverT: (973) 818-8198glenn.silver@finnpartners.com
SPAG/FINN Verlynn
Heng+65-91861225verlynn.heng@spag.asia
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