Ayala Pharmaceuticals Reports Full Year 2020 Financial Results and Provides Business Update
March 25 2021 - 8:00AM
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, primarily in genetically defined patient
populations, today reported financial results for the full year
ended December 31, 2020 and highlighted recent progress and
upcoming milestones for its pipeline programs.
“We are pleased with all that we were able to accomplish in 2020
despite the ongoing challenges of the COVID-19 pandemic, keeping
clinical execution and patient and employee safety at the forefront
of our everyday work. In 2020, we announced encouraging new data
from the Phase 2 ACCURACY study of AL101 in R/M ACC, demonstrating
initial safety and efficacy for the 4mg monotherapy cohort and we
look forward to reporting additional data, including new 6mg cohort
results from this program later this year,” said Roni Mamluk,
Ph.D., Chief Executive Officer of Ayala. “With a strong foundation
built in 2020, we have already achieved significant milestones
across our broader pipeline in 2021 with the first patient dosing
in our Phase 2 TENACITY trial in TNBC, accelerated development
pathway and pivotal trial design for AL102 in desmoid tumors, as
well as our $25 million strategic financing. We look forward to
continuing this momentum with several key clinical milestones
expected during the remainder of this year, including two new trial
initiations and interim data readouts.”
Business and Clinical Highlights
- Completed $25 million Strategic Financing: In
February 2021, Ayala announced a $25 million strategic financing
with investors including Redmile Group and SIO Capital Management,
extending its cash runway into 2023.
- Dosed First Patient in Phase 2 TENACITY Clinical Trial
of AL101 for the Treatment of Notch-Activated Triple Negative
Breast Cancer: In January 2021, Ayala announced the dosing
of the first patient in the Phase 2 TENACITY clinical trial of its
potent, selective small molecule, AL101, for the treatment of
patients with Notch-activated recurrent or metastatic (R/M) triple
negative breast cancer (TNBC).
- Accelerated Development of AL102 for the Treatment of
Desmoid Tumors with Pivotal Trial: In January 2021, Ayala
announced that based on its end-of-Phase 1 meeting with the U.S.
Food and Drug Administration (FDA) on AL102 for the treatment of
desmoid tumors, and data from AL101 and AL102 Phase 1 studies
including durable responses observed in patients with desmoid
tumors, the FDA agreed to advance the program into a Phase 2/3
pivotal trial.
- Presented Updated Positive Interim Data from Phase 2
ACCURACY Study of AL101 for the Treatment of Recurrent/Metastatic
Adenoid Cystic Carcinoma at European Society for Medical Oncology
(ESMO) Virtual Congress 2020: In September 2020, Ayala
presented updated interim data from the 4mg cohort of its ongoing
Phase 2 ACCURACY study of AL101 for the treatment of
recurrent/metastatic adenoid cystic carcinoma (R/M ACC) harboring
Notch activating mutations, demonstrating meaningful clinical
activity of AL101 4mg monotherapy with a 68% disease control rate
across 40 evaluable patients. Partial responses were observed in
six subjects (15%) and stable disease was observed in 21 subjects
(53%).
Upcoming Milestones
- On Track to Initiate Phase 2/3
Pivotal RINGSIDE Clinical Trial of AL102 for the Treatment of
Desmoid Tumors: Ayala expects to initiate the pivotal
RINGSIDE clinical trial of AL102 in adult and adolescent patients
with desmoid tumors in the first half of 2021. Ayala expects an
initial interim data read-out from part A and dose selection by
mid-2022 with part B of the study commencing immediately
thereafter.
- Patient Enrollment in 6mg
Cohort of Phase 2 ACCURACY Study Ongoing: Ayala continues
to enroll patients in the 6mg cohort of the Phase 2 ACCURACY study
of AL101 for the treatment of R/M ACC, which will contain up to 42
subjects. The Company expects to provide further trial progress
updates, including additional data, in the second half of
2021.
- TENACITY Preliminary Data to be
Reported in 2021: Ayala expects to report preliminary data
from the recently initiated Phase 2 TENACITY clinical trial of
AL101 for the treatment of R/M TNBC in the second half of
2021.
Full Year 2020 Financial Results
- Cash Position: Cash
and cash equivalents were $42.4 million as of December 31,
2020, as compared to $16.8 million as of December 31, 2019.
The increase in cash and cash equivalents was primarily due to
Ayala’s initial public offering in May 2020.
- Collaboration Revenue:
Collaboration revenue was $3.7 million for the full year of 2020,
as compared to $2.3 million for the same period in 2019. The
increase was primarily attributable to the advancement of Ayala’s
collaboration with Novartis in 2020.
- R&D Expenses:
Research and development expenses were $22.4 million for the full
year 2020, compared to $14.4 million for the same period in 2019.
The increase was primarily driven by an increase in expenses in
connection with the advancement of the clinical trials in ACC and
TNBC.
- G&A Expenses:
General and administrative expenses were $7.4 million for the
full year 2020, compared to $4.3 million for the same period in
2019. The increase was primarily related to increased costs in
connection with becoming a publicly traded company in 2020.
- Net Loss: Net loss was
$30.1 million for the full year 2020, resulting in a basic net
loss per share of $3.06 and a diluted net loss per share of $3.06.
Net loss was $17.8 million for the same period in 2019,
resulting in a basic net loss per share of $3.57 and a diluted net
loss per share of $3.57.
Financial Guidance
Ayala expects its existing cash balance to fund operating
expenses and capital expenditure requirements through multiple
potential key clinical and development milestones into 2023.
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, primarily in genetically defined patient populations.
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). Ayala’s
lead product candidate, 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.
Contacts:
Investors: Julie Seidel Stern Investor
Relations, Inc. +1-212-362-1200 Julie.seidel@sternir.com
Ayala Pharmaceuticals: +1-857-444-0553
info@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 our
development of AL101 and AL102, the promise and potential impact of
our preclinical or clinical trial data, the timing of and plans to
initiate additional clinical trials of AL101 and AL102, upcoming
milestones, including without limitation the timing and results of
any clinical trials or readouts, patient enrollment and the
sufficiency of cash to fund operations. 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 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 Annual Report on Form 10-K
for the year ended December 31, 2020 filed with the U.S. Securities
and Exchange Commission (SEC) on March 24, 2021 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.
|
AYALA PHARMACEUTICALS, INC. |
CONSOLIDATED BALANCE SHEETS |
U.S. dollars in thousands (except share and per share
data) |
|
|
|
December 31,2019 |
|
|
December 31,2020 |
|
Assets |
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
Cash and Cash Equivalents |
|
$ |
16,725 |
|
|
$ |
42,025 |
|
Short-Term Restricted Bank Deposits |
|
|
83 |
|
|
|
90 |
|
Trade Receivables |
|
|
469 |
|
|
|
681 |
|
Prepaid Expenses and Other Current Assets |
|
|
417 |
|
|
|
1,444 |
|
Total Current Assets |
|
|
17,694 |
|
|
|
44,240 |
|
Long-Term Assets: |
|
|
|
|
|
|
|
|
Other Assets |
|
|
283 |
|
|
|
305 |
|
Deferred Offering Costs |
|
|
656 |
|
|
|
— |
|
Property and Equipment, Net |
|
|
1,421 |
|
|
|
1,283 |
|
Total Long-Term Assets |
|
|
2,360 |
|
|
|
1,588 |
|
Total Assets |
|
$ |
20,054 |
|
|
$ |
45,828 |
|
Liabilities, Convertible Preferred Stock, and Stockholders’
(Deficit) Equity: |
|
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
|
|
Trade Payables |
|
$ |
2,922 |
|
|
$ |
3,726 |
|
Other Accounts Payables |
|
|
2,380 |
|
|
|
3,151 |
|
Total Current Liabilities |
|
|
5,302 |
|
|
|
6,877 |
|
Long-Term Liabilities: |
|
|
|
|
|
|
|
|
Long-Term Rent Liability |
|
|
299 |
|
|
$ |
553 |
|
Total Long-Term Liabilities |
|
$ |
299 |
|
|
$ |
553 |
|
Convertible Preferred Stock, $0.01 par value: |
|
|
|
|
|
|
|
|
Series A Preferred Stock of $0.01 par value per share; 3,700,000
shares authorized at December 31, 2019; 3,679,778 issued and
outstanding shares at December 31, 2019; aggregate liquidation
preference value of $23,919 at December 31, 2019 |
|
|
23,823 |
|
|
|
— |
|
Series B Preferred Stock of $0.01 par value per share; 4,500,000
shares authorized at December 31, 2019; 3,750,674 issued and
outstanding shares at December 31, 2019, respectively;
aggregate liquidation preference value of $29,668 at
December 31, 2019 |
|
|
29,550 |
|
|
|
— |
|
Total Convertible Preferred Stock |
|
|
53,373 |
|
|
|
— |
|
Stockholders’ (Deficit) Equity: |
|
|
|
|
|
|
|
|
Common Stock of $0.01 par value per share; 20,000,000 and
200,000,000 shares authorized at December 31, 2019 and 2020,
respectively; shares issued at December 31, 2019 and 2020,
respectively; 4,998,874 and 12,728,446 shares outstanding at
December 31, 2019 and 2020, respectively |
|
$ |
51 |
|
|
$ |
128 |
|
Additional Paid-in Capital |
|
|
1,770 |
|
|
|
109,157 |
|
Accumulated Deficit |
|
|
(40,741 |
) |
|
|
(70,887 |
) |
Total Stockholders’ (Deficit) Equity |
|
|
(38,920 |
) |
|
|
38,398 |
|
Total Liabilities, Convertible Preferred Stock, and Stockholders’
(Deficit) Equity |
|
$ |
20,054 |
|
|
$ |
45,828 |
|
|
|
|
|
|
|
|
|
|
|
AYALA PHARMACEUTICALS, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS |
U.S. dollars in thousands (except shares and per shares
data) |
|
|
|
Year
endedDecember 31,2019 |
|
|
Year
endedDecember 31,2020 |
|
Revenue from License Agreement |
|
$ |
2,334 |
|
|
$ |
3,708 |
|
Cost of Revenue |
|
|
(1,285 |
) |
|
|
(3,708 |
) |
Gross Profit |
|
|
1,049 |
|
|
|
— |
|
Research and Development |
|
$ |
14,424 |
|
|
$ |
22,406 |
|
General and Administrative |
|
|
4,336 |
|
|
|
7,371 |
|
Operating Loss |
|
|
(17,711 |
) |
|
|
(29,777 |
) |
Financial Income, Net |
|
|
225 |
|
|
|
56 |
|
Loss before Income Tax |
|
|
(17,486 |
) |
|
|
(29,721 |
) |
Taxes on Income |
|
|
(306 |
) |
|
|
(425 |
) |
Net Loss attributable to Common Stockholders |
|
$ |
(17,792 |
) |
|
$ |
(30,146 |
) |
Net Loss per Share attributable to Common Stockholders, Basic and
Diluted |
|
$ |
(3.57 |
) |
|
$ |
(3.06 |
) |
Weighted Average Shares Used to Compute Net Loss per Share, Basic
and Diluted |
|
|
4,979,606 |
|
|
|
9,860,610 |
|
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