Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage
company developing transformative therapies for the treatment of
cancer and rare diseases, today announced financial results for the
first quarter ended March 31, 2022 and provided a business update.
“The recent commencement of patient dosing in
the Phase 1 ADVANCED-1 trial of TARA-002 for non-muscle invasive
bladder cancer (NMIBC) marked an important step toward our goal of
bringing a much needed, novel therapeutic option to this
underserved population,” said Jesse Shefferman, Chief Executive
Officer of Protara Therapeutics. “Beyond NMIBC, we are encouraged
to have recently held a meeting with the U.S. Food and Drug
Administration (FDA), where we received preliminary guidance
regarding a development path for TARA-002 in lymphatic
malformations (LMs). We are currently planning to initiate a Phase
2 clinical trial in this indication subject to alignment with FDA
on a clinical trial protocol. We also remain very engaged with the
LMs treating community as we work to design a clinical study that
will further progress our program for this rare pediatric
indication that currently lacks any FDA-approved therapies.”
Recent Highlights
TARA-002 in NMIBC
- In March 2022, the Company
announced that the first patient was dosed in its Phase 1
ADVANCED-1 clinical trial evaluating TARA-002, an investigational
cell-based immunopotentiator, for the treatment of NMIBC.
TARA-002 in LMs
- The Company continues to engage
with the Vaccines and Related Products Division of the FDA and
recently received preliminary guidance regarding a potential
development path for TARA-002 in LMs. The Company is planning to
initiate a Phase 2 clinical trial of TARA-002 in this indication
subject to alignment with the agency on a clinical trial
protocol.
IV Choline Chloride in Intestinal Failure
Associated Liver Disease (IFALD)
- Protara’s prospective study to
enhance understanding of the incidence of IFALD in patients
dependent on parenteral nutrition remains ongoing. The Company
expects to use results from the prospective study, as well as its
previously completed retrospective study, to inform next steps for
the IV Choline Chloride development program.
- With respect to the IV Choline
Chloride program, in April 2022, the U.S. Patent and Trademark
Office issued to the Company a patent claiming a sterile aqueous
choline salt composition with a term expiring in 2041. The Company
expects such patent to be listed in the FDA’s “Orange Book” in the
event of the FDA’s approval of the Company’s IV Choline Chloride
product candidate.
First Quarter 2022 Financial
Results
- As of March 31, 2022, cash, cash
equivalents and restricted cash were $118.5 million. The Company
expects its current cash and cash equivalents will be sufficient to
fund its planned operations into mid-2024.
- Research and development (R&D)
expenses for the first quarter of 2022 decreased to $5.3 million
from $7.0 million during the first quarter of 2021. The decreased
R&D expenses were primarily due to decreases in manufacturing
and non-clinical expenses associated with TARA-002.
- General and administrative expenses
for the first quarter of 2022 decreased to $5.6 million from $6.5
million for the prior year period. The decrease was primarily due
to decreases in stock-based compensation.
- For the first quarter of 2022,
Protara reported a net loss of $10.8 million, or $0.96 per share,
compared with a net loss of $13.5 million, or $1.20 per share, for
the same period in 2021. Net loss for the first quarter of 2022
included approximately $1.9 million of stock-based compensation
expenses.
About TARA-002
TARA-002 is an investigational cell therapy in
development for the treatment of NMIBC and LMs for which it has
been granted Rare Pediatric Disease Designation by the U.S. Food
and Drug Administration. TARA-002 was developed from the same
master cell bank of genetically distinct group A Streptococcus
pyogenes as OK-432, a broad immunopotentiator marketed as
Picibanil® in Japan and Taiwan by Chugai Pharmaceutical Co., Ltd.
Protara has successfully demonstrated manufacturing comparability
between TARA-002 and OK-432.
When TARA-002 is administered, it is
hypothesized that innate and adaptive immune cells within the cyst
or tumor are activated and produce a strong immune cascade.
Neutrophils, monocytes and lymphocytes infiltrate the abnormal
cells and various cytokines, including interleukins IL-2, IL-6,
IL-8, IL-10, IL-12, interferon (IFN)-gamma, tumor necrosis factor
(TNF)-alpha, granulocyte colony-stimulating factor, and
granulocyte-macrophage colony-stimulating factor are secreted by
immune cells to induce a strong local inflammatory reaction and
destroy the abnormal cells.
About Non-Muscle Invasive Bladder Cancer
(NMIBC)
Bladder cancer is the 6th most common cancer in
the United States, with NMIBC representing approximately 80% of
bladder cancer diagnoses. Approximately 65,000 patients are
diagnosed with NMIBC in the United States each year. NMIBC is
cancer found in the tissue that lines the inner surface of the
bladder that has not spread into the bladder muscle.
About Lymphatic Malformations
(LMs)
LMs are rare, congenital malformations of
lymphatic vessels resulting in the failure of these structures to
connect or drain into the venous system. Most LMs are present in
the head and neck region and are diagnosed in early childhood
during the period of active lymphatic growth, with more than 50%
detected at birth and 90% diagnosed before the age of 3 years. The
most common morbidities and serious manifestations of the disease
include compression of the upper aerodigestive tract, including
airway obstruction requiring intubation and possible tracheostomy
dependence; intralesional bleeding; impingement on critical
structures, including nerves, vessels, lymphatics; recurrent
infection, and cosmetic and other functional disabilities.
About IV Choline Chloride and Intestinal
Failure-associated Liver Disease (IFALD)
IV Choline Chloride is an investigational,
intravenous (IV) phospholipid substrate replacement therapy
initially in development for patients receiving parenteral
nutrition (PN) who have IFALD. Choline is a known important
substrate for phospholipids that are critical for healthy liver
function. Because PN patients cannot sufficiently absorb adequate
levels of choline and no available PN formulations contain
sufficient amounts of choline to correct this deficiency, PN
patients often experience a prolonged progression to hepatic
failure and death, with the only known intervention being a dual
small bowel/liver transplant. If approved, IV Choline Chloride
would be the first approved therapy for IFALD. It has been granted
Orphan Drug Designations (ODDs) by the FDA for the treatment of
IFALD and the prevention of choline deficiency in PN patients.
About Protara
Therapeutics, Inc.
Protara is committed to identifying and
advancing transformative therapies for people with cancer and rare
diseases with limited treatment options. Protara’s portfolio
includes its lead program, TARA-002, an investigational cell-based
therapy being developed for the treatment of non-muscle invasive
bladder cancer and lymphatic malformations, and IV Choline
Chloride, an investigational phospholipid substrate replacement
therapy for the treatment of intestinal failure-associated liver
disease. 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,
including its development plans for its product candidates and
plans regarding the timing or outcome of existing or future
clinical trials; statements related to expectations regarding
interactions with the FDA, including potential alignment with the
FDA on clinical trial design for TARA-002 in pediatric LM patients;
Protara’s financial footing; statements regarding the anticipated
safety or efficacy of Protara’s product candidates; and Protara’s
outlook for the remainder of the year. 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 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 as well as the impact on
Protara’s contract research organizations, study sites or other
clinical partners; 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; the impact of general U.S. and foreign, economic,
industry, market, regulatory or political conditions; 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.
PROTARA THERAPEUTICS,
INC. Unaudited Condensed Consolidated Balance
Sheets(in thousands, except share and per share data)
|
|
As of |
|
|
|
March 31, 2022 |
|
|
December 31, 2021 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
25,436 |
|
|
$ |
35,724 |
|
Marketable debt securities |
|
|
62,155 |
|
|
|
55,505 |
|
Prepaid expenses and other current assets |
|
|
3,098 |
|
|
|
1,883 |
|
Total current assets |
|
|
90,689 |
|
|
|
93,112 |
|
Restricted cash,
non-current |
|
|
745 |
|
|
|
745 |
|
Marketable debt securities,
non-current |
|
|
30,889 |
|
|
|
39,467 |
|
Property and equipment,
net |
|
|
1,676 |
|
|
|
1,719 |
|
Operating lease right-of-use
asset |
|
|
6,953 |
|
|
|
7,171 |
|
Goodwill |
|
|
29,517 |
|
|
|
29,517 |
|
Other assets |
|
|
787 |
|
|
|
865 |
|
Total assets |
|
$ |
161,256 |
|
|
$ |
172,596 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
541 |
|
|
$ |
954 |
|
Accrued expenses |
|
|
1,450 |
|
|
|
2,489 |
|
Operating lease liability |
|
|
870 |
|
|
|
855 |
|
Total current liabilities |
|
|
2,861 |
|
|
|
4,298 |
|
Operating lease liability,
non-current |
|
|
6,160 |
|
|
|
6,384 |
|
Total liabilities |
|
|
9,021 |
|
|
|
10,682 |
|
Commitments and contingencies
(Note 8) |
|
|
|
|
|
|
|
|
Stockholders’ Equity: |
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par
value, authorized 10,000,000 shares:Series 1 Convertible Preferred
Stock, 8,028 shares authorized at March 31, 2022 and December 31,
2021, 8,027 shares issued and outstanding as of March 31, 2022 and
December 31, 2021. |
|
|
- |
|
|
|
- |
|
Common stock, $0.001 par
value, authorized 100,000,000 shares: |
|
|
|
|
|
|
|
|
Common stock, 11,251,927 and
11,235,731 shares issued and outstanding as of March 31, 2022 and
December 31, 2021, respectively. |
|
|
11 |
|
|
|
11 |
|
Additional paid-in
capital |
|
|
257,933 |
|
|
|
256,126 |
|
Accumulated deficit |
|
|
(104,767 |
) |
|
|
(94,012 |
) |
Accumulated other
comprehensive income (loss) |
|
|
(942 |
) |
|
|
(211 |
) |
Total stockholders’
equity |
|
|
152,235 |
|
|
|
161,914 |
|
Total liabilities and stockholders’ equity |
|
$ |
161,256 |
|
|
$ |
172,596 |
|
|
|
|
|
|
|
|
|
|
PROTARA THERAPEUTICS,
INC.Unaudited Condensed Consolidated Statements of
Operations and Comprehensive Loss(in thousands, except
share and per share data)
|
|
For the Three Months EndedMarch
31, |
|
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
5,269 |
|
|
$ |
7,040 |
|
General and administrative |
|
|
5,605 |
|
|
|
6,540 |
|
Total operating expenses |
|
|
10,874 |
|
|
|
13,580 |
|
Loss from operations |
|
|
(10,874 |
) |
|
|
(13,580 |
) |
|
|
|
|
|
|
|
|
|
Other income (expense),
net: |
|
|
|
|
|
|
|
|
Interest and investment income |
|
|
119 |
|
|
|
115 |
|
Other income (expense),
net |
|
|
119 |
|
|
|
115 |
|
Net loss |
|
|
(10,755 |
) |
|
|
(13,465 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.96 |
) |
|
$ |
(1.20 |
) |
Weighted-average shares
outstanding, basic and diluted |
|
|
11,250,127 |
|
|
|
11,226,929 |
|
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
Net unrealized (loss) gain on marketable debt securities |
|
|
(731 |
) |
|
|
(164 |
) |
Other comprehensive income
(loss) |
|
|
(731 |
) |
|
|
(164 |
) |
Comprehensive Loss |
|
$ |
(11,486 |
) |
|
$ |
(13,629 |
) |
|
|
|
|
|
|
|
|
|
Company Contact:
Justine O'MalleyProtara
TherapeuticsJustine.OMalley@protaratx.com646-817-2836
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