Protagenic Therapeutics Announces Second Quarter 2021 Results and Provides Business Update
August 17 2021 - 7:45AM
Protagenic Therapeutics, Inc. (Nasdaq: PTIX) a biopharmaceutical
company focused on developing therapies to treat stress-related
neurologic disorders, today announced results for the second
quarter ended June 30, 2021.
Recent Highlights
- Closed a $13.2 million public
offering
- Up listed to the Nasdaq Capital
Market
- Hosted a key opinion leader (KOL)
webinar focused on PT00114 for the regulation of stress in patients
with Depression, PTSD, Anxiety and Addiction
- Received FDA comment to provide
clinical sites with ready-to-inject clinical vials of PT00114; to
result in IND refiling in the fourth quarter
“During the second quarter and year to date, we
made important progress towards advancing PT00114 into the clinic,
in order to treat stress-related neuropsychiatric disorders which
afflict a growing patient population,” said Dr. Garo Armen,
Executive Chairman of Protagenic Therapeutics. “We have a clear
clinical path toward major indications. We anticipate rapid
efficacy and safety readouts in the first half of 2022.”
Anticipated Upcoming Milestones
- Q4 2021: Re-filing
of IND application for PT00114
- Q1
2022: Initiation of Phase I/IIa study for
PT00114
- 1H 2022: Initial
Data Readout of Phase I/IIa study
Financial Results for the Second Quarter Ended June
30, 2021:
- Net loss attributable to common
stockholders for the quarter ended June 30, 2021 was approximately
$1.5 million, compared to approximately $0.6 million for the
quarter ended June 30, 2020.
- Research and development expense
totaled approximately $0.1 million for the quarter ended June 30,
2021, compared to approximately $0.1 million during the quarter
ended June 30, 2020.
- General and administrative expense
was approximately $1.2 million for the quarter ended June 30, 2021,
compared to approximately $0.4 million during the quarter ended
June 30, 2020.
- On April 29, 2021, the company
closed on an underwritten public offering of 3,180,000 units at a
public offering price of $4.15 per unit. Each unit was comprised of
one share of common stock and one warrant to purchase one share of
common stock. Each warrant is exercisable at a price of $4.98 per
share and will expire five years from issuance. The common stock
and warrants comprising the units separated upon closing of the
offering and were issued separately.
- As of June 30, 2021, the Company
had cash and cash equivalents of approximately $11.9 million.
- As of August 16, 2021, the Company
had approximately 16.6 million common shares outstanding.
Select Financial Information
Protagenic Therapeutics, Inc., and
SubsidiaryCash, Cash Equivalents, and Current Assets(In U.S.
Dollars)(Unaudited)
|
|
June 30, |
|
|
December 31, |
|
|
|
2021 |
|
|
2020 |
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash |
|
$ |
11,932,973 |
|
|
$ |
671,091 |
|
Prepaid expenses |
|
|
129,167 |
|
|
|
208,156 |
|
|
|
|
|
|
|
|
|
|
TOTAL CURRENT
ASSETS |
|
|
12,062,140 |
|
|
|
879,247 |
|
|
|
|
|
|
|
|
|
|
TOTAL ASSETS |
|
$ |
12,062,140 |
|
|
$ |
879,247 |
|
Consolidated Statements of Operations (In U.S.
Dollars)(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months endedJune
30, |
|
|
For the six months ended June
30, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
OPERATING AND
ADMINISTRATIVE EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
140,592 |
|
|
|
52,008 |
|
|
|
732,943 |
|
|
|
117,967 |
|
General and
administrative |
|
|
1,168,241 |
|
|
|
436,935 |
|
|
|
1,782,080 |
|
|
|
891,712 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL OPERATING AND ADMINISTRATIVE EXPENSES |
|
|
1,308,833 |
|
|
|
488,943 |
|
|
|
2,515,023 |
|
|
|
1,009,679 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS FROM
OPERATIONS |
|
|
(1,308,833 |
) |
|
|
(488,943 |
) |
|
|
(2,515,023 |
) |
|
|
(1,009,679 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER (EXPENSE)
INCOME |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
227 |
|
|
|
93 |
|
|
|
232 |
|
|
|
477 |
|
Interest expense |
|
|
(239,190 |
) |
|
|
(54,944 |
) |
|
|
(323,127 |
) |
|
|
(93,930 |
) |
Change in fair value of derivative liability |
|
|
- |
|
|
|
(23,560 |
) |
|
|
83,670 |
|
|
|
37,189 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL OTHER INCOME (EXPENSES) |
|
|
(238,963 |
) |
|
|
(78,411 |
) |
|
|
(239,225 |
) |
|
|
(56,264 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS BEFORE
TAX |
|
|
(1,547,796 |
) |
|
|
(567,354 |
) |
|
|
(2,754,248 |
) |
|
|
(1,065,943 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INCOME TAX
EXPENSE |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS |
|
$ |
(1,547,796 |
) |
|
$ |
(567,354 |
) |
|
$ |
(2,754,248 |
) |
|
$ |
(1,065,943 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COMPREHENSIVE
LOSS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Comprehensive
Loss - net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange translation income (loss) |
|
|
482 |
|
|
|
1,084 |
|
|
|
973 |
|
|
|
(1,335 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL COMPREHENSIVE
LOSS |
|
$ |
(1,547,314 |
) |
|
$ |
(566,270 |
) |
|
$ |
(2,753,275 |
) |
|
$ |
(1,067,278 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share -
Basic and Diluted |
|
$ |
(0.11 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.22 |
) |
|
$ |
(0.10 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
- Basic and Diluted |
|
|
14,487,277 |
|
|
|
10,261,419 |
|
|
|
12,488,906 |
|
|
|
10,261,419 |
|
See accompanying notes to these unaudited
consolidated financial statements in our Form 10-Q filed with the
SEC August 16, 2021
About Protagenic Therapeutics, Inc.
Protagenic Therapeutics, Inc. (Nasdaq: PTIX) is
a pre-clinical biopharmaceutical company endeavoring to develop
first-in-class neuro-active peptides into human therapeutics to
treat several stress related disorders. For more information, visit
http://www.protagenic.com.
Forward-Looking Statements
This press release contains forward-looking
statements that are made pursuant to the safe harbor provisions of
the federal securities laws, including statements regarding
Protagenic Therapeutics’ product candidates and pre-clinical
development and clinical trial plans and activities.
Forward-looking statements include words such as "expects,"
"anticipates," "intends," "plans," "could," "believes," "estimates"
and similar expressions. These forward-looking statements are
subject to risks and uncertainties that could cause actual results
to differ materially. These risks and uncertainties include, among
others, our ability to obtain additional capital to meet our
liquidity needs on acceptable terms, or at all, including the
additional capital which will be necessary to complete the
pre-clinical testing and eventual clinical trials of our product
candidates; our ability to successfully complete research and
further development and commercialization of our product
candidates; the uncertainties inherent in pre-clinical and clinical
testing; the timing, cost and uncertainty of obtaining regulatory
approvals; our ability to protect the Company's intellectual
property; the loss of any executive officers or key personnel or
consultants; competition; changes in the regulatory landscape or
the imposition of regulations that affect the Company's products;
and the other factors described under the Risk Factors section of
our most recent Annual Report on Form 10-K filed with the
Securities and Exchange Commission.. Protagenic Therapeutics
cautions investors not to place considerable reliance on the
forward-looking statements contained in this release. These
statements speak only as of the date of this press release, and
Protagenic undertakes no obligation to update or revise the
statements, other than to the extent required by law. All
forward-looking statements are expressly qualified in their
entirety by this cautionary statement.
Analyst Contact:Alexander K.
Arrow, MD, CFA Chief Financial
Officer213-260-4342alex.arrow@protagenic.com
Media Contact:James CarbonaraHayden
IR(646)-755-7412james@haydenir.com
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