Ayala Pharmaceuticals Announces $25 Million Strategic Financing
February 19 2021 - 9:29AM
Ayala Pharmaceuticals, Inc. (NASDAQ: AYLA), a clinical-stage
oncology company focused on developing and commercializing small
molecule therapeutics for patients suffering from rare and
aggressive cancers, today announced that it has entered into a
definitive agreement for the sale of its equity securities in a
private placement to institutional investors, including Redmile
Group and SIO Capital Management.
"We are very excited to have obtained additional funding
enabling us to execute on our strategic priorities and support
business growth from high quality US healthcare dedicated funds,
which we also expect will extend our cash runway into 2023,” said
Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. “Ayala is
well capitalized as we approach several key milestones planned for
the remainder of 2021. We look forward to initiating our pivotal
Phase 2/3 study of AL102 for the treatment of desmoid tumors in the
first half of this year and presenting data from our Phase 2 study
of AL101 for the treatment of recurrent/metastatic adenoid cystic
carcinoma and triple negative breast cancer later this year.”
The agreement provides for the sale of an aggregate of 1,666,666
units at a price of $15 per unit. Each unit consists of one share
of Ayala’s common stock and a warrant to purchase 0.35 of a share
of common stock at an exercise price of $18.10 (the “Warrant”). One
institutional investor has elected to receive pre-funded warrants
to purchase common stock in lieu of its common stock. The Warrants
are exercisable at any time during the period beginning on the
closing date of the private placement and ending on the third
anniversary of the closing. The gross proceeds from the sales of
common stock are expected to be approximately $25 million, before
deducting placement agent fees and offering expenses. The private
placement is expected to close on or about February 23, 2021,
subject to the satisfaction of customary closing conditions.
Jefferies LLC is acting as the exclusive placement agent for the
private placement.
Based on Ayala’s current plans, it believes that its existing
cash and cash equivalents and short-term restricted bank deposits,
with the expected net proceeds from the private placement, will be
sufficient to fund its operating expenses and capital expenditure
requirements through multiple expected catalysts into 2023.
The securities to be sold in the private placement have not been
registered under the Securities Act of 1933, as amended (Securities
Act), or any state or other applicable jurisdiction’s securities
laws, and may not be offered or sold in the United States absent
registration or an applicable exemption from the registration
requirements of the Securities Act and applicable state or other
jurisdictions’ securities laws.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy these securities, nor shall there
be any offer, solicitation or sale of these securities in any
jurisdiction in which such offer, solicitation or sale would be
unlawful.
About Ayala Pharmaceuticals
Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company
focused on developing and commercializing small molecule
therapeutics for patients suffering from rare and aggressive
cancers. Ayala’s approach is focused on predicating, identifying
and addressing tumorigenic drivers of cancer through a combination
of its bioinformatics platform and next-generation sequencing to
deliver targeted therapies to underserved patient populations. The
company has two product candidates under development, AL101 and
AL102, targeting the aberrant activation of the Notch pathway with
gamma secretase inhibitors to treat a variety of tumors including
Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC),
T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and
Multiple Myeloma (MM) (in collaboration with Novartis). AL101 has
received Fast Track Designation and Orphan Drug Designation from
the U.S. FDA and is currently in a Phase 2 clinical trial for
patients with ACC (ACCURACY) bearing Notch activating mutations and
in a Phase 2 clinical trial for patients with TNBC (TENACITY)
bearing Notch activating mutations and other gene rearrangements.
AL102 is currently being advanced to a Phase 2/3 clinical trials
for patients with desmoid tumors (RINGSIDE). For more information,
visit www.ayalapharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained in this press release that do not
relate to matters of historical fact should be considered
forward-looking statements, including statements relating to the
sufficiency of our cash, cash equivalents, restricted banks
deposits and the net proceeds from the private placement to fund
our operating expenses and capital expenditure requirements, the
timing of clinical trials, the gross proceeds from the private
placement, the closing of the private placement, and the use of
proceeds from the private placement. These forward-looking
statements are based on management’s current expectations. The
words “may,” “will,” “should,” “expect,” “plan,” “anticipate,”
“could,” “intend,” “target,” “project,” “estimate,” “believe,”
“predict,” “potential” or “continue” or the negative of these terms
or other similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. These statements are
neither promises nor guarantees, but involve known and unknown
risks, uncertainties and other important factors that may cause our
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements, including,
but not limited to, the following: the impact of the COVID-19
pandemic on our operations, including our preclinical studies and
clinical trials, and the continuity of our business; we have
incurred significant losses, are not currently profitable and may
never become profitable; our need for additional funding; our
expectations regarding our cash runway; our limited operating
history and the prospects for our future viability; the lengthy,
expensive, and uncertain process of clinical drug development,
including potential delays in regulatory approval; our requirement
to pay significant payments under product candidate licenses; the
approach we are taking to discover and develop product candidates
and whether it will lead to marketable products; the expense,
time-consuming nature and uncertainty of clinical trials;
enrollment and retention of patients; potential side effects of our
product candidates; our ability to develop or to collaborate with
others to develop appropriate diagnostic tests; protection of our
proprietary technology and the confidentiality of our trade
secrets; potential lawsuits for, or claims of, infringement of
third-party intellectual property or challenges to the ownership of
our intellectual property; risks associated with international
operations; our ability to retain key personnel and to manage our
growth; the potential volatility of our common stock; costs and
resources of operating as a public company; unfavorable or no
analyst research or reports; and securities class action litigation
against us. These and other important factors discussed under the
caption “Risk Factors” in our Quarterly Report on Form 10-Q for the
three months ended September 30, 2020 filed with the U.S.
Securities and Exchange Commission (SEC) on November 16, 2020 and
our other filings with the SEC could cause actual results to differ
materially from those indicated by the forward-looking statements
made in this press release. Any such forward-looking statements
represent management’s estimates as of the date of this press
release. New risk factors and uncertainties may emerge from time to
time, and it is not possible to predict all risk factors and
uncertainties. While we may elect to update such forward-looking
statements at some point in the future, except as required by law,
we disclaim any obligation to do so, even if subsequent events
cause our views to change. Although we believe the expectations
reflected in such forward-looking statements are reasonable, we can
give no assurance that such expectations will prove to be correct.
These forward-looking statements should not be relied upon as
representing our views as of any date subsequent to the date of
this press release.
Contacts:
Investors:Julie SeidelStern Investor Relations,
Inc.+1-212-362-1200Julie.seidel@sternir.com
Ayala
Pharmaceuticals:+1-857-444-0553info@ayalapharma.com
Ayala Pharmaceuticals (NASDAQ:AYLA)
Historical Stock Chart
From Jun 2024 to Jul 2024
Ayala Pharmaceuticals (NASDAQ:AYLA)
Historical Stock Chart
From Jul 2023 to Jul 2024