Azitra, Inc. (NYSE American: AZTR), a clinical-stage
biopharmaceutical company focused on developing innovative
therapies for precision dermatology, today reported financial
results for the third quarter ended September 30, 2023.
Q3 and Recent Business Highlights
- Advanced its pipeline programs including ATR-12 (Netherton
syndrome), ATR-04 (EGFRi-associated rash) and its Joint Development
Agreement with Bayer
- Completed and filed post-IND, FDA commitments for
characterization of drug product for ATR-12
- Selected and hired clinical research organization for ATR-12
clinical trial. Selected initial sites for activation
Francisco Salva, Chief Executive Officer of Azitra,
commented:
“During the third quarter, we made important progress towards
reaching multiple significant near-term milestones. Firstly, for
our lead program ATR-12 for Netherton syndrome, we’ve selected and
hired our clinical research organization for the Netherton syndrome
clinical trial. Additionally, we are in discussion with our lead
sites to get the program activated and start recruiting an initial
~12 patients. We’re now poised for key catalysts, including first
patient enrolled, followed by initial clinical data in 2024.”
“Next, for our ATR-04 program targeting EGFRi-associated rash,
we’ve been advancing towards our IND (Investigational New Drug)
filing to enable clinical development. We are moving through the
necessary preclinical and manufacturing activities. We are now
building towards several pivotal events over the next 12 to 18
months, starting with IND submission, followed by enrolling ~15
patients, and then announcing data.”
“Additionally, regarding our Joint Development Agreement with
Bayer, we are very pleased with the recent progress of our
collaboration.”
Pipeline and Upcoming
Milestones
- ATR-12 - Netherton syndrome (rare skin disease
with no FDA approved treatment options). Global Prevalence: 20K+
patients. Estimated Peak Sales Opportunity: ~$250 million.
- Clinical Status: Phase 1b IND cleared
- Upcoming milestones:
- First patient enrolled (FPI)
- Initial clinical data
- ATR-04 - EGFRi-associated rash (Chemotherapy agents such
as EGFR inhibitors and immunotherapies such as early BTK inhibitors
lead to an aggressive and debilitating rash on many patients). US
Prevalence: 200K+ patients. Estimated Peak Sales Opportunity:
>$1B.
- Clinical Status: Pre-IND
- Upcoming milestones:
- Preclinical animal data
- IND submission
- Bayer Joint Development Agreement (Joint development on
S. epidermidis strains and products for eczema-prone skin.) Global
Prevalence: 230 million. Annual economic burden in Europe: $30B.
- Status: Azitra is responsible for early research, and Bayer is
responsible for clinical development and commercialization
- Upcoming milestones:
- Execution of royalty-bearing licensing agreement
Financial Results for the Three Months Ended September 30,
2023
- Cash and cash equivalents: As of September 30, 2023, the
Company had cash and cash equivalents of $4.4 million.
- Service Revenue – Related Party: The Company generated
$310,700 of service revenue during the three months ended September
30, 2023 compared to $48,500 for the comparable period in
2022.
- Research and Development (R&D) expenses: R&D
expenses for the three months ended September 30, 2023 were
$548,524 compared to $1.4 million from the prior year period.
- General and Administrative (G&A) expenses: G&A
expenses for the three months ended September 30, 2023 were $1.8
million compared to $1.1 million from the prior year period.
- Net Loss was $1.9 million for the three months ended
September 30 2023, compared to $2.4 million for the same period in
2022.
About Azitra, Inc.
Azitra, Inc. is an early-stage clinical biopharmaceutical
company focused on developing innovative therapies for precision
dermatology using engineered proteins and topical live
biotherapeutic products. The Company has built a proprietary
platform that includes a microbial library comprised of
approximately 1,500 unique bacterial strains that can be screened
for unique therapeutic characteristics. The platform is augmented
by artificial intelligence and machine learning technology that
analyzes, predicts and helps screen the Company's library of
strains for drug like molecules. The Company's initial focus is on
the development of genetically engineered strains of Staphylococcus
epidermidis, or S. epidermidis, which the Company considers to be
an optimal therapeutic candidate species for engineering of
dermatologic therapies. For more information, please visit
https://azitrainc.com/.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended. These statements may be identified by words such
as "aims," "anticipates," "believes," "could," "estimates,"
"expects," "forecasts," "goal," "intends," "may," "plans,"
"possible," "potential," "seeks," "will," and variations of these
words or similar expressions that are intended to identify
forward-looking statements. Any such statements in this press
release that are not statements of historical fact may be deemed to
be forward-looking statements. These forward-looking statements
include, without limitation, statements regarding the expected
timing of the presentation of data from the Phase 1b study of
ATR-12, the filing of an IND application, and the presentation of
data from our Phase 1b for ATR-04, the IND filing for ATR-01, the
timing of having a signed license agreement with Bayer, and
statements about our clinical and pre-clinical programs, and
corporate and clinical/pre-clinical strategies.
Any forward-looking statements in this press release are based
on current expectations, estimates and projections only as of the
date of this release and are subject to a number of risks and
uncertainties that could cause actual results to differ materially
and adversely from those set forth in or implied by such
forward-looking statements. These risks and uncertainties include,
but are not limited to that we may fail to successfully complete
our Phase 1b trial for ATR-12 and pre-clinical studies of other
product candidates and obtain required approval before
commercialization; our product candidates may not be effective;
there may be delays in regulatory approval or changes in regulatory
framework that are out of our control; our estimation of
addressable markets of our product candidates may be inaccurate; we
may fail to timely raise additional required funding; more
efficient competitors or more effective competing treatment may
emerge; we may be involved in disputes surrounding the use of our
intellectual property crucial to our success; we may not be able to
attract and retain key employees and qualified personnel; earlier
study results may not be predictive of later stage study outcomes;
and we are dependent on third-parties for some or all aspects of
our product manufacturing, research and preclinical and clinical
testing. Additional risks concerning Azitra's programs and
operations are described in its registration statement on Form S-1,
which is on file with the SEC, and in its most recent quarterly
report on Form 10-Q to be filed with the SEC. Azitra explicitly
disclaims any obligation to update any forward-looking statements
except to the extent required by law.
Condensed Consolidated
Statement of Operations
(Unaudited)
Three months Ended September
30,
2023
2022
Service revenue – related party
$
310,700
$
48,500
Total revenue
310,700
48,500
Operating expenses:
General and administrative
1,755,908
1,054,570
Research and development
548,524
1,364,380
Total operating expenses
2,304,432
2,418,950
Loss from operations
(1,993,732
)
(2,370,450
)
Other income (expense):
Interest income
634
3,201
Interest expense
(710
)
(31,333
)
Other expense
50,519
(19,038
)
Total other income (expense)
50,443
(47,170
)
Net loss before income taxes
(1,943,289
)
(2,417,620
)
Income tax benefit (expense)
-
-
Net loss
$
(1,943,289
)
(2,417,620
)
Dividends on preferred stock
-
(692,246
)
Net loss attributable to common
shareholders
$
(1,943,289
)
(3,109,866
)
Net loss per Share, basic and diluted
(.16
)
(2.95
)
Weighted average common stock outstanding,
basic and diluted
$
12,097,643
$
1,055,455
Condensed Consolidated Balance
Sheets
(Unaudited)
September 30,
December 31,
2023
2022
Assets
Current Assets:
Cash and cash equivalents
$
4,400,327
$
3,492,656
Other receivables
54,247
266,208
Prepaid expenses and other current
assets
409,170
377,019
Total current assets
$
4,863,744
$
4,135,883
Property and equipment, net
736,423
846,958
Other assets
1,890,077
2,184,602
Total assets
$
7,490,244
$
7,167,443
Liabilities, preferred stock, and
stockholders’ equity
Current liabilities:
Accounts payable
$
417,928
$
784,687
Current financing lease liability
14,254
-
Current operating lease liability
301,423
287,384
Accrued expenses
720,095
993,961
Contract liabilities
-
156,000
Total current liabilities
1,453,700
2,222,032
Long-term financing lease liability
29,952
-
Long-term operating lease liability
613,572
840,896
Warrant liability
60,933
70,283
Convertible notes payable, net
0
6,600,000
Total liabilities
2,158,157
9,733,211
Stockholders’ equity (deficit)
Preferred stock
0
33,694,542
Common stock
1,210
104
Additional paid-in capital
51,475,425
1,054,138
Accumulated deficit
(46,144,548
)
(37,314,552
)
Total stockholders’ equity (deficit)
5,332,087
(36,260,310
)
Total liabilities, preferred stock and
stockholders’ equity (deficit)
$
7,490,244
$
7,167,443
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231114034406/en/
Norman Staskey Chief Financial Officer staskey@azitra.com
Hayden IR James Carbonara (646) 755-7412 james@haydenir.com
Azitra (AMEX:AZTR)
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