Ayala Pharmaceuticals Reports Second Quarter 2021 Financial Results and Provides Business Update
13 8월 2021 - 9:00PM
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 period ended
June 30, 2021 and highlighted recent progress and upcoming
milestones for its pipeline programs.
“Ayala is well positioned for strong clinical progress
throughout the remainder of this year. In the second quarter, we
continued to advance our pipeline programs and we are gearing up
for a data readout from AL101 in our ACCURACY trial in adenoid
cystic carcinoma at the upcoming ESMO meeting in September, while
also advancing our AL102 clinical trials in desmoid tumors and
multiple myeloma,” said Roni Mamluk, Ph.D., Chief Executive Officer
of Ayala. “Our science is deeply rooted in the promise of
predicting, identifying and addressing tumorigenic drivers of
cancer and we continue to see value in our approach combining
bioinformatics and next-generation sequencing. There remains a
significant unmet need among patients with genetically defined
cancers and we believe that our pipeline has the potential to
address the ongoing shortfalls of existing therapies.”
Recent Business Highlights and Upcoming
Milestones:
- Enrolled First Patient in the Phase 2/3 RINGSIDE Trial
of AL102 for the Treatment of Desmoid Tumors: Ayala
recently enrolled the first patient in its pivotal Phase 2/3
RINGSIDE trial of AL102 for the treatment of desmoid tumors with
multiple sites open in the U.S. and globally.
Ayala expects to report an initial interim data read-out from part
A of the trial in mid-2022, with part B of the study commencing
thereafter.
- Dosed First Patient in the Phase 1 Trial of AL102 in
Combination with Novartis’ BCMA Targeting Agent, WVT087 for the
Treatment of Relapsed/Refractory Multiple Myeloma: In
April 2021, Ayala announced the dosing of the first patient in the
Phase 1 combination trial of AL102 with Novartis’ investigational
anti-B-cell maturation antigen (BCMA) agent, WVT078, for the
treatment of relapsed and/or refractory (R/R) multiple myeloma
(MM).
- Phase 2 TENACITY Trial of AL101 for the Treatment of
Triple Negative Breast Cancer Continues to Progress: Ayala
continues to enroll patients in the Phase 2 TENACITY clinical trial
of its potent, selective small molecule gamma secretase inhibitor
(GSI), AL101, for the treatment of patients with Notch-activated
recurrent or metastatic (R/M) triple negative breast cancer (TNBC).
The Company expects to report preliminary data from this ongoing
trial in 2022.
- On Track to Report Additional ACCURACY Phase 2 Data;
Patient Enrollment in 6mg Cohort of Phase 2 ACCURACY Study
Completed: Ayala completed enrollment of patients in the
6mg cohort of the Phase 2 ACCURACY study of AL101 for the treatment
of R/M adenoid cystic carcinoma (ACC), which includes 42 subjects.
Further trial progress updates, including additional data, will be
presented at the upcoming European Society for Medical Oncology
(ESMO) 2021 Congress being held virtually September 16-21,
2021.
Second Quarter 2021 Financial Results
- Cash Position: Cash and cash equivalents were
$44.4 million as of June 30, 2021, as compared to
$42.0 million as of December 31, 2020.
- Collaboration Revenue: Collaboration revenue
was $0.8 million for the second quarter of 2021, as compared to
$1.0 million for the same period in 2020.
- R&D Expenses: Research and development
expenses were $8.1 million for the second quarter of 2021, compared
to $5.1 million for the same period in 2020. The increase was
primarily driven by the advancement of Ayala’s clinical
programs.
- G&A Expenses: General and administrative
expenses were $2.5 million for the second quarter of 2021,
compared to $1.5 million for the same period in 2020. The increase
was primarily related to costs associated with becoming a public
company.
- Net Loss: Net loss was $10.8 million for
the second quarter of 2021, resulting in a basic and diluted net
loss per share of $0.75 Net loss was $6.7 million for the same
period in 2020, resulting in a basic and diluted net loss per share
of $0.74.
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). 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 in a Pivotal Phase 2/3 clinical trials for
patients with desmoid tumors (RINGSIDE) and is being evaluated in a
Phase 1 clinical trial in combination with Novartis’ BMCA targeting
agent, WVT078, in Patients with relapsed/refractory Multiple
Myeloma. For more information, visit www.ayalapharma.com.
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)
|
|
June 30 |
|
December 31 |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
(Unaudited) |
|
|
|
|
|
CURRENT
ASSETS: |
|
|
|
|
|
|
|
|
Cash and Cash Equivalents |
|
$ |
44,412 |
|
|
$ |
42,025 |
|
Short-term Restricted Bank Deposits |
|
|
119 |
|
|
|
90 |
|
Trade Receivables |
|
|
929 |
|
|
|
681 |
|
Prepaid Expenses
and other Current Assets |
|
|
1,550 |
|
|
|
1,444 |
|
Total Current
Assets |
|
|
47,010 |
|
|
|
44,240 |
|
LONG-TERM
ASSETS: |
|
|
|
|
|
|
|
|
Other Assets |
|
$ |
270 |
|
|
$ |
305 |
|
Property and Equipment, Net |
|
|
1,192 |
|
|
|
1,283 |
|
Total Long-Term
Assets |
|
|
1,462 |
|
|
|
1,588 |
|
Total Assets |
|
$ |
48,472 |
|
|
$ |
45,828 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY: |
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES: |
|
|
|
|
|
|
|
|
Trade
Payables |
|
$ |
2,833 |
|
|
$ |
3,726 |
|
Other Accounts
Payables |
|
|
2,377 |
|
|
|
3,151 |
|
Total Current
Liabilities |
|
|
5,210 |
|
|
|
6,877 |
|
LONG TERM
LIABILITIES: |
|
|
|
|
|
|
|
|
Long-term Rent Liability |
|
|
502 |
|
|
|
553 |
|
Total Long-Term Liabilities |
|
$ |
502 |
|
|
$ |
553 |
|
STOCKHOLDERS’ STOCKHOLDERS’ EQUITY: |
|
|
|
|
|
|
|
|
Common Stock of
$0.01 par value per share; 200,000,000 shares authorized at June
30, 2021 and December 31, |
|
|
|
|
|
|
|
|
2020; 13,240,961 and 12,824,463 shares issued at June 30, 2021 and,
respectively December 31, 2020; 13,092,925 |
|
|
|
|
|
|
|
|
and 12,728,446 shares outstanding at June 30, 2021 and December 31,
2020, respectively |
|
$ |
131 |
|
|
$ |
128 |
|
Additional Paid-in Capital |
|
|
133,925 |
|
|
|
109,157 |
|
Accumulated Deficit |
|
|
(91,296 |
) |
|
|
(70,887 |
) |
Total
Stockholders’ Equity |
|
|
42,760 |
|
|
|
38,398 |
|
Total Liabilities
and Stockholders’ Equity |
|
$ |
48,472 |
|
|
$ |
45,828 |
|
|
|
|
|
|
|
|
|
|
AYALA PHARMACEUTICALS,
INC. CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited) (In thousands, except
share & per share amounts)
|
|
For the Three Months Ended |
|
For the Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues from licensing
agreement |
|
$ |
761 |
|
|
$ |
1,045 |
|
|
$ |
1,735 |
|
|
$ |
2,046 |
|
Cost of services |
|
|
(761 |
) |
|
|
(1,045 |
) |
|
|
(1,735 |
) |
|
|
(2,046 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
8,121 |
|
|
|
5,067 |
|
|
|
15,046 |
|
|
|
10,195 |
|
General and administrative |
|
|
2,536 |
|
|
|
1,546 |
|
|
|
4,839 |
|
|
|
2,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(10,657 |
) |
|
|
(6,613 |
) |
|
|
(19,885 |
) |
|
|
(13,052 |
) |
Financial Income (Loss),
net |
|
|
(22 |
) |
|
|
40 |
|
|
|
(114 |
) |
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income tax |
|
|
(10,679 |
) |
|
|
(6,573 |
) |
|
|
(19,999 |
) |
|
|
(13,050 |
) |
Taxes on income |
|
|
(162 |
) |
|
|
(139 |
) |
|
|
(410 |
) |
|
|
(260 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to
common stockholders |
|
|
(10,841 |
) |
|
|
(6,712 |
) |
|
|
(20,409 |
) |
|
|
(13,310 |
) |
Net Loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.75 |
) |
|
$ |
(0.74 |
) |
|
$ |
(1.46 |
) |
|
$ |
(1.90 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
14,417,423 |
|
|
|
9,018,637 |
|
|
|
13,954,676 |
|
|
|
6,989,762 |
|
Ayala Pharmaceuticals (NASDAQ:AYLA)
과거 데이터 주식 차트
부터 11월(11) 2024 으로 12월(12) 2024
Ayala Pharmaceuticals (NASDAQ:AYLA)
과거 데이터 주식 차트
부터 12월(12) 2023 으로 12월(12) 2024