NeOnc Technologies Holdings, Inc., a clinical-stage medical
biotechnology company, has completed a $18.5 million financing to
support the ongoing development and Phase I and II clinical studies
of its novel drug and delivery methods designed to address the
persistent challenges with overcoming the blood-brain barrier.
The financing secured $4.5 million in new equity investment from
existing and new investors. It also converted to equity all
outstanding notes held by lenders along with accounts payable to
University of Southern California (USC) totaling $14 million,
thereby eliminating all outstanding short-term debt. The
transactions were completed with the issuance of Class A common
stock priced at $12 per share.
The financing sets NeOnc’s post-money valuation at approximately
$220 million, an increase of 214% from the previous $10 million
equity funding the company announced in February of last year. It
brings the total amount of committed equity since inception to more
than $31 million.
The new financing supports further development and expansion of
NeOnc’s NEO™ platform technology that has generated an extensive
patent portfolio. Secured under exclusive worldwide rights from
USC, NeOnc’s intellectual property portfolio includes 135 U.S. and
international patents issued and patents pending.
The company believes the funding also provides the financial and
net equity requirements for a potential direct listing on a
national stock exchange.
“We believe this latest funding round and debt conversion
demonstrates the strong confidence in our technology and future
growth prospects expressed by both new and existing investors, as
well as by our strategic research partners at USC,” stated NeOnc
executive chairman, Amir Heshmatpour. “It underscores our
commitment to fortifying our financial position as we complete our
current clinical trials. It also opens the door to a number of
options we now enjoy for accessing the capital markets that would
be most favorable to our investors and invested management
team.”
According to NeOnc’s founder, CEO and CSO, Thomas Chen, M.D.,
Ph.D.: “Most importantly, the funding supports our mission of
improving and extending the lives of brain cancer patients by
developing therapies that maximize the effectiveness and delivery
of current standard-of-care drugs for brain cancer.”
Dr. Chen is a widely respected neurosurgery professor and
medical expert who brings to NeOnc more than 30 years of medical
and clinic research experience. A board-certified neurosurgeon, he
is also currently the director of Surgical Neuro-Oncology at USC.
He was recognized last year for his achievements by the American
Health Council with its coveted Best in Medicine Award.
NeOnc’s proprietary biotechnology breakthroughs are the result
of more than a decade of research and development by Dr. Chen and
his accomplished medical and scientific teams. Dr. Chen has been
leading the company’s Phase I and II clinical trials.
Metastases to the brain are the most common brain tumors in
adults and this develops in nearly 30% of patients with solid
tumors. Traditional cytotoxic drugs have had a limited role in the
management of these cancers and no standard systemic therapy
exists.
“We believe one of our lead drug candidates, NEO212™, could have
a meaningful impact on solid tumor patients who develop
uncontrolled brain metastasis and who are often excluded from
traditional clinical trials,” noted Dr. Chen. “We also believe that
NEO212 may have the potential to treat primary brain tumors as well
as potentially work with systemic therapy to improve outcomes in
patients who develop brain metastasis.”
By enabling greater penetration of the blood-brain barrier, Dr.
Chen believes the company’s NEO technology can turn existing
FDA-approved drugs into more effective treatments across a full
range of central nervous system (CNS) disorders. The company is
currently developing several additional proprietary chemotherapy
agents that have demonstrated positive effects in laboratory tests
on other various types of cancers.
NeOnc has secured FDA Fast-Track status for its leading drug
candidates that supports its clinical trials. FDA grants Fast-Track
status when a drug is shown to treat a serious condition and
provides an unmet medical need or therapy that may be potentially
better than other available therapies. The criteria includes if the
drug will impact survival and day-to-day functioning, or if left
untreated, the disease will progress from a less severe condition
to a more serious one.
The drug must also show superior effectiveness, significant
decrease in serious side effects and the ability to improve the
diagnosis of a serious condition. Additionally, it must demonstrate
a decrease in clinically significant toxicity over available
therapies, and an ability to address emerging or anticipated public
health needs.
NeOnc has also secured the FDA’s classification as an Orphan
Drug (OD). OD status is granted by the FDA to a substance that
shows promise in treating, preventing or diagnosing an “orphan
disease;” that is, diseases that currently affect less than 200,000
people. OD status provides a seven-year window of exclusive
marketing rights, fee reductions, and additional tax incentives.
The FDA gathers and shares information from Patient-Focused Drug
Development (PFDD) meetings which companies like NeOnc can use in
its drug development.
OD status also provides a more streamlined clinical trial
process, including not having to perform Phase I safety studies,
binding, placebo, and randomization criteria. Once sufficient
effectiveness and safety data is shown, a New Drug Application
(NDA) can be submitted for a Fast-Track review by the FDA.
“In consultation with the FDA under OD and Fast-Track status, we
expect to collect sufficient data that demonstrates the important
therapeutic value of our lead drug candidates,” added Dr. Chen. “We
believe our novel intranasal delivery approach makes a study in a
pediatric population, in particular, easier than other methods.
Radiation and chemotherapy for children with high-grade gliomas is
complex, time consuming and prognosis remains poor. All this
underscores the importance of developing effective therapies that
are less invasive and more tolerant for pediatric and other
challenged populations.”
The NEO drug development platform addresses a global CNS
treatment market that is projected to grow at a 9.4% CAGR to $166.5
billion by 2028. The global brain tumor drug market is projected to
expand at a 10.2% CAGR to reach $3.7 billion by 2030.
Driving this growth is an increasing incidence of such diseases
with the aging population. However, radiation therapy still
accounts for 38% of the brain cancer treatment market, with drug
treatment remaining second to radiation therapy mostly due to
current inefficiencies of drug delivery.
About NeOnc Technologies Holdings NeOnc
Technologies is a privately held clinical stage life sciences
company focused on the development and commercialization of central
nervous system therapeutics that are designed to address the
persistent challenges in overcoming the blood-brain barrier.
The company’s NEO™ drug development platform has produced a
portfolio of novel drug candidates and delivery methods with patent
protections extending to 2038. These proprietary chemotherapy
agents have demonstrated positive effects in laboratory tests on
various types of cancers and in clinical trials treating malignant
gliomas. NeOnc’s NEO100™ and NEO212™ therapeutics are in Phase II
human clinical trials, and are advancing under FDA Fast-Track and
Investigational New Drug (IND) status.
The company has exclusively licensed an extensive worldwide
patent portfolio from the University of Southern California
consisting of issued patents and pending applications related to
NEO100, NEO212, and other products from the NeOnc patent family for
multiple uses, including oncological and neurological
conditions.
For more about NeOnc and its pioneering technology, visit
neonctech.com. Important Cautions
Regarding Forward-Looking Statements All statements
other than statements of historical facts included in this press
release are "forward-looking statements" (as defined in the Private
Securities Litigation Reform Act of 1995). Generally, such
forward-looking statements include statements regarding our
expectations, possible or assumed future actions, business
strategies, events, or results of operations, including statements
regarding our expectations or predictions or future financial or
business performance or conditions and those statements that use
forward-looking words such as "projected," "expect," "possibility"
and "anticipate," or similar expressions. The achievement or
success of the matters covered by such forward-looking statements
involve significant risks, uncertainties, and assumptions. Actual
results could differ materially from current projections or implied
results.
NeOnc Technologies Holding, Inc. (the "Company") cautions that
statements and assumptions made in this news release constitute
forward-looking statements without guaranteeing future performance.
Forward-looking statements are based on estimates and opinions of
management at the time statements are made. The information set
forth herein speaks only as of the date hereof. The Company and its
management are under no obligation, and expressly disclaim any
obligation, to update, alter, or otherwise revise any
forward-looking statements following the date of this news release,
whether because of new information, future events, or otherwise,
except as required by law.
NeOnc Company Contact: Patrick Walters,
COO NeOnc Technologies Holdings, Inc. Email
Contact
NeOnc Investor Relations: Ron Both or
Grant StudeCMA Investor Relations Tel (949)
432-7566 Email Contact
NeOnc Media Contact: Tim Randall CMA
Media Relations Tel (949) 432-7572 Email
Contact