Protara Therapeutics Announces Second Quarter 2020 Financial Results and Business Overview
August 03 2020 - 7:00AM
Protara Therapeutics, Inc. (Nasdaq: TARA), a development-stage
company developing treatments for rare and specialty diseases with
significant unmet needs, today announced financial results for the
second quarter ended June 30, 2020.
“We are committed to advancing our pipeline of
potentially transformative therapies in several areas of high unmet
need,” said Jesse Shefferman, Chief Executive Officer of Protara
Therapeutics. “We recently received Rare Pediatric Disease
Designation for TARA-002, our lead product candidate, for the
treatment of Lymphatic Malformations. We look forward to
working with the FDA to determine next steps for the program and we
are continuing to evalutate its potential in oncologic
indications.”
Mr. Shefferman continued, “In addition, we
recently announced receipt of Fast Track Designation for IV Choline
Chloride for the treatment of IFALD, which we believe speaks to its
potential to serve as a much-needed therapy for this patient
population. With a resolve to improve the lives of the patients we
serve, we expect the remainder of the year to be a productive time
for Protara as we execute our strategy.”
Recent Highlights
TARA-002
- Received Rare Pediatric
Disease Designation from FDA for TARA-002 for the Treatment of
Lymphatic Malformations. In July
2020, Protara announced that the U.S. Food
and Drug Administration (FDA) granted Rare Pediatric Disease
designation for TARA-002 for the treatment of Lymphatic
Malformations (LMs). TARA-002 is an investigational cell-based
therapy based on the broad immunopotentiator OK-432, which is
approved in Japan and Taiwan for the treatment of LMs.The FDA
grants Rare Pediatric Disease designation for serious diseases that
primarily affect children ages 18 years or younger and fewer than
200,000 persons in the United States. Under
the FDA's Rare Pediatric Disease Priority Review Voucher
program, a sponsor who receives an approval of a new drug
application or biologics license application for a product for the
prevention or treatment of a rare pediatric disease may be eligible
for a voucher, which can be redeemed to obtain priority review for
any subsequent marketing application or may be sold or
transferred.
IV Choline Chloride
- Received Fast Track
Designation from FDA for Intravenous Choline Chloride for the
Treatment of Intestinal Failure Associated Liver Disease.
In May 2020, Protara announced that the U.S.
FDA granted Fast Track Designation to Intravenous (IV) Choline
Chloride for the treatment of intestinal failure-associated liver
disease (IFALD). IV Choline Chloride is Protara’s Phase 3-ready
investigational phospholipid substrate replacement therapy for
patients receiving parenteral nutrition (PN) who have IFALD.
Company Updates
- Appointed Barry P.
Flannelly to the Board of Directors. In July 2020, Protara
announced the appointment of Barry P. Flannelly, Pharm.D, to its
Board of Directors. Dr. Flannelly currently serves as Executive
Vice President, General Manager, U.S. at Incyte, bringing over 20
years of commercial and business development leadership experience
across numerous leading pharmaceutical and biotech companies.
Second Quarter 2020 Results from
Operations
- Protara reported a net loss
of $7.1 million for the second quarter of 2020 as
compared to a net loss of $1.4 million for the three months ended
June 30, 2019. The second quarter of 2020 included
approximately $1.8 million of stock-based compensation
expense.
- Research and Development expenses
were $2.5 million for the second quarter of 2020, an increase of
$1.5 million as compared to the three months ended June 30, 2019.
The increase was primarily associated with activities related to
TARA-002.
- General and Administrative expenses
were $4.8 million for the second quarter of 2020, which represented
an increase of $4.4 million as compared to the three months ended
June 30, 2019. The increase was primarily related to an
increase in stock-based compensation and professional fees
associated with becoming a public company.
- As of June 30, 2020, cash,
cash equivalents and restricted cash were $30.0 million.
A Form 10-Q containing the full financial statements was filed
this morning and is available for viewing on Protara’s website
at www.protaratx.com or www.sec.gov.
About Protara Therapeutics,
Inc.
Protara is committed to identifying and
advancing transformative therapies for people with rare and
specialty diseases who have limited treatment options. Protara’s
portfolio includes its lead program, TARA-002, an investigational
cell-based therapy being developed for the treatment of lymphatic
malformations, and IV Choline Chloride, an investigational
phospholipid substrate replacement therapy for the treatment of
IFALD. For more information, visit www.protaratx.com.
Forward-Looking Statements
Statements contained in this press release
regarding matters that are not historical facts are "forward
looking statements" within the meaning of the Private Securities
Litigation Reform Act of 1995. Protara may, in some cases, use
terms such as “predicts,” “believes,” “potential,” “proposed,”
“continue,” “designed,” “estimates,” “anticipates,” “expects,”
“plans,” “intends,” “may,” “could,” “might,” “will,” “should” or
other words or expressions referencing future events, conditions or
circumstances that convey uncertainty of future events or outcomes
to identify these forward-looking statements. Such forward-looking
statements include but are not limited to, statements regarding
Protara’s intentions, beliefs, projections, outlook, analyses or
current expectations concerning, among other things: Protara’s
business strategy, Protara’s development plans for its product
candidates and related interactions with the FDA, Protara’s
financial footing, the impact of the COVID-19 pandemic and related
governmental responses on Protara’s business and clinical programs.
Because such statements are subject to risks and uncertainties,
actual results may differ materially from those expressed or
implied by such forward-looking statements. Factors that contribute
to the uncertain nature of the forward-looking statements include:
risks that Protara’s sales, revenue, expense and other financial
guidance may not be as expected, as well as risks and uncertainties
associated with: Protara’s development programs, including the
initiation and completion of non-clinical studies and clinical
trials and the timing of required filings with the FDA and other
regulatory agencies; the impact of the COVID-19 pandemic on
Protara’s business and the global economy; general market
conditions; changes in the competitive landscape; changes in
Protara’s strategic and commercial plans; Protara’s ability to
obtain sufficient financing to fund its strategic plans and
commercialization efforts; having to use cash in ways or on timing
other than expected; the impact of market volatility on cash
reserves; the loss of key members of management; and the risks and
uncertainties associated with Protara’s business and financial
condition in general, including the risks and uncertainties
described more fully under the caption "Risk Factors" and elsewhere
in Protara's filings and reports with the United States Securities
and Exchange Commission. All forward-looking statements contained
in this press release speak only as of the date on which they were
made and are based on management's assumptions and estimates as of
such date. Protara undertakes no obligation to update any
forward-looking statements, whether as a result of the receipt of
new information, the occurrence of future events or otherwise,
except as required by law.
Company Contact:
Blaine Davis Protara Therapeutics Blaine.Davis@protaratx.com
646-844-0337
|
PROTARA THERAPEUTICS, INC. |
CONDENSED CONSOLIDATED BALANCE SHEETS |
|
|
|
|
|
As of |
|
June 30, 2020 |
|
December 31, 2019 |
|
(unaudited) |
|
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
29,970,617 |
|
|
$ |
564,124 |
|
Restricted cash |
|
50,000 |
|
|
|
- |
|
Deferred offering costs |
|
- |
|
|
|
121,712 |
|
Prepaid expenses and other current assets |
|
2,828,556 |
|
|
|
78,057 |
|
Total current assets |
|
32,849,173 |
|
|
|
763,893 |
|
|
|
|
|
Non-current assets: |
|
|
|
Property and equipment, net |
|
655,495 |
|
|
|
458,591 |
|
Right-of-use asset |
|
384,081 |
|
|
|
- |
|
Goodwill |
|
29,367,213 |
|
|
|
- |
|
Total assets |
$ |
63,255,962 |
|
|
$ |
1,222,484 |
|
|
|
|
|
Liabilities and Stockholders' Equity
(Deficit) |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
915,206 |
|
|
$ |
715,653 |
|
Accrued expenses |
|
1,575,068 |
|
|
|
2,634,790 |
|
Short-term debt |
|
926,983 |
|
|
|
- |
|
Right-of-use liability, current |
|
29,287 |
|
|
|
- |
|
Total current liabilities |
|
3,446,544 |
|
|
|
3,350,443 |
|
|
|
|
|
Non-current liabilities: |
|
|
|
Right-of-use liability, long-term |
|
378,885 |
|
|
|
- |
|
Total liabilities |
|
3,825,429 |
|
|
|
3,350,443 |
|
|
|
|
|
Commitments and Contingencies (Note 6) |
|
|
|
|
|
|
|
Stockholders' Equity (Deficit) |
|
|
|
Preferred Stock, $0.001 par value, authorized 10,000,000
shares: |
|
|
|
Series 1 Convertible Preferred Stock, 3,880 and 0 shares authorized
at June 30, 2020 and December 31, 2019, respectively, 3,879 and 0
shares issued and outstanding as of June 30, 2020 and December 31,
2019, respectively. |
|
4 |
|
|
|
- |
|
Common Stock, $0.001 par value, authorized 100,000,000 shares: |
|
|
|
Common Stock, 5,843,203 and 2,627,533 common shares issued and
outstanding as of |
|
|
|
June 30, 2020 and December 31, 2019, respectively. |
|
5,843 |
|
|
|
2,628 |
|
Additional Paid in Capital |
|
89,406,633 |
|
|
|
10,651,073 |
|
Accumulated Deficit |
|
(29,981,947 |
) |
|
|
(12,781,660 |
) |
Total Stockholders' Equity (Deficit) |
|
59,430,533 |
|
|
|
(2,127,959 |
) |
Total Liabilities and Stockholders' Equity
(Deficit) |
$ |
63,255,962 |
|
|
$ |
1,222,484 |
|
|
|
|
|
PROTARA THERAPEUTICS, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(unaudited) |
|
|
|
|
|
|
|
|
|
For the Three Months Ended June 30, |
|
For the Six Months Ended June 30, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
|
|
|
|
|
|
Operating expense: |
|
|
|
|
|
|
|
Research & development |
$ |
2,469,720 |
|
|
$ |
986,716 |
|
|
$ |
5,534,513 |
|
|
$ |
2,064,562 |
|
General & administrative |
|
4,796,155 |
|
|
|
441,959 |
|
|
|
11,890,987 |
|
|
|
892,169 |
|
Total operating expenses |
|
7,265,875 |
|
|
|
1,428,675 |
|
|
|
17,425,500 |
|
|
|
2,956,731 |
|
|
|
|
|
|
|
|
|
Operating loss |
|
(7,265,875 |
) |
|
|
(1,428,675 |
) |
|
|
(17,425,500 |
) |
|
|
(2,956,731 |
) |
|
|
|
|
|
|
|
|
Other (income) expense, net |
|
|
|
|
|
|
|
Interest (income) expense, net |
|
(125,845 |
) |
|
|
- |
|
|
|
(225,213 |
) |
|
|
- |
|
Total other (income) expense, net |
|
(125,845 |
) |
|
|
- |
|
|
|
(225,213 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
Net Loss |
$ |
(7,140,030 |
) |
|
$ |
(1,428,675 |
) |
|
$ |
(17,200,287 |
) |
|
$ |
(2,956,731 |
) |
|
|
|
|
|
|
|
|
Weighted Average Shares Outstanding, basic and diluted |
|
5,843,203 |
|
|
|
2,558,419 |
|
|
|
5,701,855 |
|
|
|
2,558,419 |
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
$ |
(1.22 |
) |
|
$ |
(0.56 |
) |
|
$ |
(3.02 |
) |
|
$ |
(1.16 |
) |
|
|
|
|
|
|
|
|
Protara Therapeutics (NASDAQ:TARA)
Historical Stock Chart
From Jun 2024 to Jul 2024
Protara Therapeutics (NASDAQ:TARA)
Historical Stock Chart
From Jul 2023 to Jul 2024