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
full year and fourth quarter ended December 31, 2022, and provided
a business update.
“With key data and milestones expected from our
clinical programs for TARA-002, including data from the Phase 1a
portion of the ADVANCED-1 trial in non-muscle invasive bladder
cancer (NMIBC) in the second quarter of 2023, we believe this year
will be a particularly exciting time for Protara,” said Jesse
Shefferman, Chief Executive Officer of Protara Therapeutics. “We
look forward to leveraging data from the ADVANCED-1 trial to inform
the design of further clinical studies in our NIMBC program. For
our program in lymphatic malformations (LMs), a highly underserved
pediatric population for which we believe TARA-002 could serve as a
meaningful intervention, we have begun Phase 2 clinical trial start
up activities and anticipate initiating the trial in the second
half of this year. We believe we are well positioned to
successfully execute on our pipeline programs and look forward to
providing updates in due course.”
Recent Highlights
TARA-002 in NMIBC
- In December 2022, the Company’s
Phase 1 ADVANCED-1 clinical trial of TARA-002, Protara’s
investigational cell-based immunopotentiator for the treatment of
NMIBC, was featured in a Trials in Progress poster at the Annual
Meeting of the Society of Urologic Oncology.
- The Company expects to report data
from the Phase 1a portion of the trial in the second quarter of
2023 and move rapidly into the Phase 1b expansion portion of the
trial, which will evaluate safety and efficacy in patients with
carcinoma in situ (CIS).
TARA-002 in LMs
- The Company has initiated study
start up activities for a Phase 2 clinical trial of TARA-002 in
pediatric patients with macrocystic and mixed-cystic LMs.
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 is ongoing with results expected
in the third quarter of 2023.
- The Company plans to leverage
results from the prospective study, as well as its completed
retrospective study, to inform next steps for the IV Choline
Chloride development program.
Corporate Updates
- In January 2023, Protara announced
the appointment of Patrick Fabbio as Chief Financial Officer. Mr.
Fabbio brings to Protara more than 30 years of experience at
various life science and pharmaceutical companies and most recently
served as President and Chief Financial Officer at NYSE-listed
Rafael Holdings, Inc.
Fourth Quarter and Full Year 2022
Financial Results
- As of December 31, 2022, cash, cash
equivalents and marketable debt securities totaled $102.3 million.
The Company expects its cash, cash equivalents, and marketable debt
securities will be sufficient to fund its planned operations and
data milestones into 2025.
- Research and development expenses
for the fourth quarter of 2022 increased to $5.0 million from $4.1
million for the prior year period, and for the full year decreased
to $16.8 million compared to $21.1 million for 2021. The fourth
quarter increase was primarily due to an increase in non-clinical
studies performed in the quarter versus the comparable period. The
full year decrease was primarily due to a reduction in clinical
manufacturing expenses.
- General and administrative expenses
for the fourth quarter of 2022 decreased to $5.0 million from $6.2
million for the prior year period, and for the full year decreased
to $20.7 million compared to $26.4 million for 2021. The fourth
quarter and full year decreases were primarily due to a reduction
in stock based compensation expense and market development
activities.
- For the fourth quarter of 2022,
Protara reported a net loss of $39.0 million, or $3.46 per share,
compared with a net loss of $10.2 million, or $0.91 per share, for
the same period in 2021. Net loss in the fourth quarter of 2022
included a non-cash goodwill impairment charge of $29.5 million
associated with the accounting for the reverse merger transaction
in January of 2020. Net loss for the year ended December 31, 2022
was $66.0 million, or $5.86 per share, compared with a net loss of
$47.3 million, or $4.21 per share, for the year ended December 31,
2021. Net loss for the fourth quarter included approximately $1.4
million of stock-based compensation expenses. Net loss for the year
ended December 31, 2022 included approximately $6.7 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 advancing transformative therapies for
people with cancer and rare diseases. 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; Protara’s financial position;
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; 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 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; 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.Consolidated Balance Sheets(in
thousands, except share and per share data)
|
|
December 31, |
|
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
24,127 |
|
|
$ |
35,724 |
|
Marketable debt securities |
|
|
60,243 |
|
|
|
55,505 |
|
Prepaid expenses and other current assets |
|
|
1,776 |
|
|
|
1,883 |
|
Total current assets |
|
|
86,146 |
|
|
|
93,112 |
|
Restricted cash, non-current |
|
|
745 |
|
|
|
745 |
|
Marketable debt securities, non-current |
|
|
17,886 |
|
|
|
39,467 |
|
Property and equipment, net |
|
|
1,592 |
|
|
|
1,719 |
|
Operating lease right-of-use asset |
|
|
6,277 |
|
|
|
7,171 |
|
Goodwill |
|
|
- |
|
|
|
29,517 |
|
Other assets |
|
|
644 |
|
|
|
865 |
|
Total assets |
|
$ |
113,290 |
|
|
$ |
172,596 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,586 |
|
|
$ |
954 |
|
Accrued expenses |
|
|
3,237 |
|
|
|
2,489 |
|
Operating lease liability |
|
|
917 |
|
|
|
855 |
|
Total current liabilities |
|
|
5,740 |
|
|
|
4,298 |
|
Operating lease liability, non-current |
|
|
5,467 |
|
|
|
6,384 |
|
Total liabilities |
|
|
11,207 |
|
|
|
10,682 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Stockholders’ Equity |
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value, authorized 10,000,000
shares: |
|
|
|
|
|
|
|
|
Series 1 convertible preferred stock, 8,028 shares authorized at
December 31, 2022 and 2021, respectively 8,027 shares issued and
outstanding as of December 31, 2022 and 2021, respectively. |
|
|
- |
|
|
|
- |
|
Common stock, $0.001 par value, authorized 100,000,000 shares: |
|
|
|
|
|
|
|
|
Common stock, 11,267,389 and 11,235,731 shares issued and
outstanding as of December 31, 2022 and 2021, respectively. |
|
|
11 |
|
|
|
11 |
|
Additional paid in capital |
|
|
262,724 |
|
|
|
256,126 |
|
Accumulated deficit |
|
|
(159,964 |
) |
|
|
(94,012 |
) |
Accumulated other comprehensive income (loss) |
|
|
(688 |
) |
|
|
(211 |
) |
Total stockholders’ equity |
|
|
102,083 |
|
|
|
161,914 |
|
Total liabilities and stockholders’ equity |
|
$ |
113,290 |
|
|
$ |
172,596 |
|
Protara Therapeutics,
Inc.Consolidated Statements of Operations and
Comprehensive Loss(in thousands, except share and per
share data)
|
(Unaudited) |
|
|
(Audited) |
|
|
Three months ended |
|
|
Years Ended December 31, |
|
|
|
12/31/2022 |
|
|
|
12/31/2021 |
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
4,989 |
|
|
$ |
4,068 |
|
|
$ |
16,808 |
|
|
$ |
21,088 |
|
General and administrative |
|
5,003 |
|
|
|
6,220 |
|
|
|
20,737 |
|
|
|
26,401 |
|
Loss on impairment of goodwill |
|
29,517 |
|
|
|
- |
|
|
|
29,517 |
|
|
|
- |
|
Total operating expenses |
|
39,509 |
|
|
|
10,288 |
|
|
|
67,062 |
|
|
|
47,489 |
|
Loss from operations |
|
(39,509 |
) |
|
|
(10,288 |
) |
|
|
(67,062 |
) |
|
|
(47,489 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and investment income |
|
543 |
|
|
|
59 |
|
|
|
1,110 |
|
|
|
237 |
|
Net loss |
|
38,966 |
|
|
|
(10,229 |
|
|
|
(65,952 |
) |
|
|
(47,252 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share attributable to common stockholders, basic and
diluted |
$ |
(3.46 |
) |
|
$ |
(0.91 |
) |
|
$ |
(5.86 |
) |
|
$ |
(4.21 |
) |
Weighted average shares outstanding, basic and diluted |
|
11,267,389 |
|
|
|
11,235,731 |
|
|
|
11,259,615 |
|
|
|
11,232,576 |
|
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized (loss) gain on marketable debt securities |
|
442 |
|
|
|
(172 |
) |
|
|
(477 |
) |
|
|
(211 |
) |
Other comprehensive income (loss) |
|
442 |
|
|
|
(172 |
) |
|
|
(477 |
) |
|
|
(211 |
) |
Comprehensive Loss |
$ |
(38,524 |
) |
|
$ |
(10,401 |
) |
|
$ |
(66,429 |
) |
|
$ |
(47,463 |
) |
Company Contact:
Justine O'MalleyProtara
TherapeuticsJustine.OMalley@protaratx.com646-817-2836
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