BRANFORD, Conn., Aug. 14,
2023 /PRNewswire/ -- Azitra, Inc. (NYSE American:
AZTR), a clinical-stage biopharmaceutical company focused on
developing innovative therapies for precision dermatology, today
reported financial results for the second quarter ended
June 30, 2023.
Francisco Salva, Chief Executive
Officer of Azitra, commented, "We are extremely pleased with the
exciting recent progress at Azitra, and we are thrilled to have
closed on our initial public offering in June. This year, we have
demonstrated the potential of our regulatory, manufacturing, and
clinical capabilities that resulted in a new IND for ATR-12 for a
Phase 1b clinical trial in Netherton
syndrome. Additionally, we are very pleased with the recent
progress of our platform and collaboration with Bayer."
Recent Business Highlights
- Completed an initial public offering: In June, the
Company raised $7.5 million in gross
proceeds in an initial public offering before deducting
underwriting discounts and offering expenses.
- Announced key appointments to executive team and board of
directors: The Company made several key appointments during
recent months, including Travis
Whitfill as Chief Operating Officer and Barbara Ryan and John
Schroer to its board of directors.
- Obtained IND clearance of ATR-12 for a Phase 1b clinical trial in Netherton syndrome
Financial Results for the Three Months Ended June 30, 2023
- Cash and cash equivalents: As of June 30, 2023, the Company had cash and cash
equivalents of $6.3 million, which
includes the proceeds from an initial public offering in
June 2023.
- Service Revenue – Related Party: The Company generated
$172,000 of service revenue during
the three months ended June 30, 2023
compared to service revenue of $85,000 for the comparable period in 2022. The
increase of $87,000 in service
revenue is attributable to an increase in the amount of
reimbursable development costs incurred in 2023.
- Research and Development (R&D) expenses: R&D
expenses for the three months ended June 30,
2023 were $812,836 compared to
$1.5 million from the prior year
period. The decrease was primarily related to a decrease of
$575,000 in research and development
related costs attributable to our efforts in moving our Netherton
syndrome program forward and a net decrease in payroll and related
costs of $120,000 attributable to a
reduction in staff offset by a net increase in other costs of
$2,389. There was no government and
nonprofit grant revenue received by us during the second quarter of
fiscal 2023 or 2022.
- General and Administrative (G&A) expenses: G&A
expenses for the three months ended June 30,
2023 were $844,640 compared to
$667,940 from the prior year period.
The increase was primarily related to an increase of $259,000 in accounting, legal, hiring, and
insurance costs offset by a decrease of $80,000 in payroll and related costs attributable
to the discontinuation of separation benefits paid to our former
chief operating officer, and $2,300
net decrease of other overhead expenses.
- Net Loss was $4.4 million
for the three months ended June 30
2023, compared to $1.9 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.
Company Contact
Norman Staskey
Chief Financial Officer
staskey@azitra.com
Condensed
Consolidated Statement of Operations
|
(Unaudited)
|
|
|
|
Three months Ended
June 30,
|
|
|
2023
|
|
|
2022
|
Service revenue –
related party
|
|
$
|
172,000
|
|
|
$
|
85,000
|
Total
revenue
|
|
|
172,000
|
|
|
|
85,000
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
General and
administrative
|
|
|
844,640
|
|
|
|
667,940
|
Research and
development
|
|
|
812,836
|
|
|
|
1,505,447
|
Total operating
expenses
|
|
|
1,657,476
|
|
|
|
2,173,387
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
(1,485,476)
|
|
|
|
(2,088,387)
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
income
|
|
|
265
|
|
|
|
335
|
Interest
expense
|
|
|
(76,187)
|
|
|
|
(17,811)
|
Employee retention
credit
|
|
|
-
|
|
|
|
229,813
|
Other income
|
|
|
1,600
|
|
|
|
-
|
Forgiveness of accounts
payable
|
|
|
56,285
|
|
|
|
-
|
Change in fair value of
convertible note
|
|
|
(2,830,100)
|
|
|
|
-
|
Other
expense
|
|
|
(95,915)
|
|
|
|
(14,103)
|
Total other income
(expense)
|
|
|
(2,944,052)
|
|
|
|
198,234
|
|
|
|
|
|
|
|
|
Net loss before income
taxes
|
|
|
(4,429,528)
|
|
|
|
(1,890,153)
|
|
|
|
|
|
|
|
|
Income tax benefit
(expense)
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(4,429,528)
|
|
|
|
(1,890,153)
|
Dividends on preferred
stock
|
|
|
(643,267)
|
|
|
|
(692,246)
|
Net loss attributable
to common shareholders
|
|
$
|
(5,072,795)
|
|
|
|
(2,582,399)
|
Net loss per Share,
basic and diluted
|
|
|
(2.36)
|
|
|
|
(2.45)
|
Weighted average common
stock outstanding, basic and diluted
|
|
$
|
2,147,526
|
|
|
$
|
1,055,454
|
Condensed
Consolidated Balance Sheets
|
(Unaudited)
|
|
|
|
June
30,
|
|
|
December
31,
|
|
|
2023
|
|
|
2022
|
Assets
|
|
|
|
|
|
|
|
Current
Assets:
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
6,290,355
|
|
|
$
|
3,492,656
|
Other receivables
|
|
|
501,288
|
|
|
|
266,208
|
Prepaid expenses and other
current assets
|
|
|
48,523
|
|
|
|
377,019
|
Total current
assets
|
|
$
|
6,840,166
|
|
|
$
|
4,135,883
|
Property and
equipment, net
|
|
|
803,107
|
|
|
|
846,958
|
Other assets
|
|
|
2,186,284
|
|
|
|
2,184,602
|
Total assets
|
|
$
|
9,829,557
|
|
|
$
|
7,167,443
|
Liabilities,
preferred stock, and stockholders' equity
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
364,183
|
|
|
$
|
784,687
|
Current operating lease
liability
|
|
|
298,047
|
|
|
|
287,384
|
Accrued
expenses
|
|
|
767,721
|
|
|
|
993,961
|
Contract
liabilities
|
|
|
310,700
|
|
|
|
156,000
|
Total current
liabilities
|
|
|
1,740,651
|
|
|
|
2,222,032
|
Long-term operating lease
liability
|
|
|
693,609
|
|
|
|
840,896
|
Warrant liability
|
|
|
158,994
|
|
|
|
70,283
|
Convertible notes payable,
net
|
|
|
0
|
|
|
|
6,600,000
|
Total
liabilities
|
|
|
2,593,254
|
|
|
|
9,733,211
|
Stockholders' equity
(deficit)
|
|
|
|
|
|
|
|
Preferred stock
|
|
|
0
|
|
|
|
33,694,542
|
Common stock
|
|
|
1,210
|
|
|
|
104
|
Additional paid-in
capital
|
|
|
51,436,352
|
|
|
|
1,054,138
|
Accumulated
deficit
|
|
|
(44,201,259)
|
|
|
|
(37,314,552)
|
Total stockholders' equity
(deficit)
|
|
|
7,236,303
|
|
|
|
(36,260,310)
|
Total liabilities,
preferred stock and stockholders' equity (deficit)
|
|
$
|
9,829,557
|
|
$
|
|
7,167,443
|
|
|
|
|
|
|
|
|
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SOURCE Azitra, Inc.