Allena Pharmaceuticals (NASDAQ:ALNA), a late-stage,
biopharmaceutical company dedicated to developing and
commercializing first-in-class, oral enzyme therapeutics to treat
patients with rare and severe metabolic and kidney disorders, today
reported financial results for the second quarter ended June 30,
2020 and provided a business update.
“In concert with our recent financings, our team has moved
quickly to implement planned activities across our portfolio,
including the expansion of URIROX-2 clinical trial sites and the
initiation of our Phase 1 study of ALLN-346. We are grateful for
the effort and attention of our URIROX-2 trial investigators and
business partners, which has enabled us to enroll patients in this
second Phase 3 trial, even in the midst of the pandemic. This
is the final study necessary for filing and approval of reloxaliase
as a first-in-class therapy for patients with enteric
hyperoxaluria,” said Louis Brenner, M.D., President and Chief
Executive Officer of Allena Pharmaceuticals. “We are also excited
to announce the initiation of our first-in-human study of ALLN-346,
our second novel, oral enzyme therapeutic. We are initially
developing ALLN-346 for the treatment of renally impaired patients
with hyperuricemia and gout, for whom existing treatment options
are inadequate due to safety and dosing limitations. As we look to
the second half of 2020, we remain on track to achieve all of our
clinical development milestones, with initial data for ALLN-346
expected by year end and the first interim analysis from URIROX-2
expected in the first quarter of 2022.”
Recent Business Highlights and Upcoming
Milestones:
Reloxaliase: Reloxaliase is a first-in-class,
non-absorbed, orally administered enzyme for the treatment of
severe hyperoxaluria. Allena is currently evaluating reloxaliase
for patients with enteric hyperoxaluria (EH) in URIROX-2, the
second pivotal Phase 3 clinical trial in its URIROX program. Allena
is actively expanding to new sites and new geographies in its
ongoing URIROX-2 clinical trial. The Company continues to expect
the interim analysis in the first quarter of 2022 and to announce
topline data supporting a potential Biologics License Application
(BLA) submission in the third quarter of 2022.
Allena continues to engage with the U.S. Food and Drug
Administration (FDA) to explore potential expedited registration
paths for reloxaliase in patients with EH and advanced chronic
kidney disease (CKD).
ALLN-346: ALLN-346 is a first-in-class,
orally administered, novel urate degrading enzyme that has been
designed for activity and stability in the gastrointestinal tract
for the treatment of hyperuricemia in patients with gout in the
setting of advanced CKD. In July 2020, Allena initiated a Phase 1
clinical trial of ALLN-346. Initial data is expected in the
fourth quarter of 2020.
Corporate: In June 2020, Allena completed a
registered direct offering of common stock and, in July 2020, an
underwritten offering of common stock. Together, these transactions
netted gross proceeds to Allena of $22.7 million.
Second Quarter 2020 Financial Results:
- Cash Position: As of June 30, 2020,
cash and cash equivalents were $26.5 million, as compared
to $30.0 million as of December 31, 2019. This
decrease was primarily due to cash used in operating activities and
payments of principal and interest made on the Company’s credit
facility, partially offset by gross proceeds of approximately $15.0
million received from the company’s June 2020 registered direct
offering. Cash and cash equivalents as of June 30, 2020 do not
include gross proceeds of approximately $7.7 million received from
the company’s bought deal offering, which closed in July 2020.
- R&D Expenses: R&D expenses
were $3.8 million for the second quarter of 2020 as
compared to $8.6 million for the second quarter of 2019. The
decrease was primarily due to a reduction of costs incurred for the
reloxaliase program, including costs for the URIROX-1 and URIROX-2
trials, and a reduction of costs incurred for the ALLN-346 program,
including costs for formulation and development relating to its
investigational new drug (IND) application. During the fourth
quarter of 2019, the Company completed its URIROX-1 trial and filed
an IND for ALLN-346 with the FDA.
- G&A Expenses: G&A expenses
were $2.8 million for the second quarter of 2020 as
compared to $2.7 million for the second quarter of 2019. This
increase was due to increases in compensation and benefit costs,
the majority of which were related to stock-based compensation,
partially offset by decreases in consulting and professional
services costs.
- Net Loss: Net loss was $7.0
million for the second quarter of 2020, or a net loss per
basic and diluted share of $0.26, as compared to a net loss
of $11.3 million for the second quarter of 2019, or a net
loss per basic and diluted share of $0.54.
Financial Guidance:Based on its current plans,
Allena expects that its existing cash and cash equivalents will be
sufficient to fund its operating expenses and capital expenditure
requirements beyond the second quarter of 2021.
About Allena Pharmaceuticals
Allena Pharmaceuticals, Inc. is a late-stage
biopharmaceutical company dedicated to developing and
commercializing first-in-class, oral enzyme therapeutics to treat
patients with rare and severe metabolic and kidney disorders.
Allena’s lead product candidate, reloxaliase, is a first-in-class,
oral enzyme therapeutic for the treatment of hyperoxaluria, a
metabolic disorder characterized by markedly elevated urinary
oxalate levels and commonly associated with kidney stones, chronic
kidney disease and other serious kidney disorders.
Forward-Looking Statements
This release contains “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995,
including, without limitation, statements regarding the statements
regarding implementation of the amended trial design
for URIROX-2 , the timing of sample size reassessments
and interim analyses during the URIROX-2 trial, Allena’s
ability to utilize the accelerated approval regulatory pathway for
reloxaliase, statements concerning the future clinical, regulatory
and commercial potential of reloxaliase, statements regarding the
Allena’s development of ALLN-346, statements regarding Allena’s
financial position and need for capital. In addition, it should be
noted that additional capital will be required to complete the
planned URIROX-2 clinical trial, including the planned
interim analysis at the first sample size reassessment, which
capital may not be available to Allena on terms that are acceptable
to it, if at all. If adequate funds are not available on a timely
basis, Allena may be required to delay, limit, reduce or terminate
its clinical development of reloxaliase. The impact of the
COVID-19 coronavirus on Allena’s business, the biotech sector
generally and the broader macroeconomic environment is uncertain
and could harm Allena’s business by delaying regulatory review
timelines, clinical development plans and our ability to raise
necessary capital. Furthermore, Allena does not have sufficient
cash to operate its business for the next 12 months, which raises
substantial doubt about its ability to continue as a going concern.
Allena will require additional capital to fund its planned
operations, which may not be available to it on attractive terms or
at all. If the company is unable to secure additional capital, it
will be forced to delay, limit, reduce or terminate its development
of reloxaliase and may not be able to continue as a going concern.
Any forward-looking statements in this press release are based on
management’s current expectations of future events 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: the risk that the
results of the URIROX-1 clinical trial may not be
replicated in the URIROX-2 or other clinical trials of
reloxaliase; the risk that the reduction in 24-hour UOx
excretion observed in the placebo arm of
the URIROX-1 trial may be observed in
the URIROX-2 or other clinical trials of reloxaliase,
which may have a negative impact on Allena’s ability to secure
regulatory approval for this product candidate; the risk that
results of earlier studies, or interim results, may not be
predictive of future clinical trial results, and planned and
ongoing studies may not establish an adequate safety or efficacy
profile for reloxaliase to support regulatory approval or the use
of the accelerated approval regulatory pathway; risks related to
Allena’s ability to utilize the accelerated approval pathway for
reloxaliase, including the risk that available data at the time of
any sample size re-estimation or interim analysis
conducted during the URIROX-2 trial may not be sufficient
to demonstrate an increased probability of kidney stone events in
patients with enteric hyperoxaluria and increasing UOx levels; the
risk that the FDA may require that Allena increase the sample size
or duration of treatment following the sample size reassessments to
be conducted in accordance with the adaptive design element of the
trial or otherwise collect additional clinical data from
the URIROX-2 or other clinical trials prior to submitting
a BLA for reloxaliase; risks associated with Allena’s ability to
enroll a sufficient number of patients to adequately
power URIROX-2 in order to achieve ultimate statistical
success for kidney stone disease progression in the
long-term follow-up phase of the trial; risks related to
Allena’s use of UOx and/or POx as surrogate endpoints in its
ongoing clinical trials, neither of which it believes have been
previously utilized as biomarkers to support regulatory approval of
other drug candidates, and the risks related to validating that
reductions in UOx and/or POx correlate with meaningful clinical
benefit; risks associated with obtaining, maintaining and
protecting intellectual property; risks associated with Allena’s
ability to enforce its patents against infringers and defend its
patent portfolio against challenges from third parties; the risk of
competition from other companies developing products for similar
uses; risk associated with Allena’s financial condition and its
need to obtain additional funding to support its business
activities, including the future clinical development of
reloxaliase and its ability to continue as a going concern; risks
associated with Allena’s dependence on third parties; and risks
related to the COVID-19 coronavirus. For a discussion of other
risks and uncertainties, and other important factors, any of which
could cause Allena’s actual results to differ from those contained
in the forward-looking statements, see the section entitled “Risk
Factors” in Item 1A of Part I of Allena’s Quarterly Report on
Form 10-Q for the quarter ended June 30, 2020, as
well as discussions of potential risks, uncertainties and other
important factors in Allena’s subsequent filings with
the Securities and Exchange Commission. All information in
this press release is as of the date of the release, and Allena
undertakes no duty to update this information unless required by
law.
|
Allena Pharmaceuticals, Inc |
Selected Condensed Consolidated Balance Sheet
Data |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
As of June 30, 2020 |
|
As of December 31, 2019 |
Cash and cash equivalents |
|
$ |
26,453 |
|
$ |
30,007 |
Working capital (1) |
|
|
21,633 |
|
|
22,127 |
Total assets |
|
|
29,108 |
|
|
34,108 |
Loan payable, net of current
portion and discount |
|
|
3,992 |
|
|
5,988 |
Total stockholders' equity |
|
|
18,373 |
|
|
17,198 |
|
|
|
|
|
(1) The Company
defines working capital as current assets less current
liabilities. See the Company's condensed consolidated
financial statements for further detail regarding its current
assets and current liabilities. |
|
Allena Pharmaceuticals, Inc |
Condensed Consolidated Statements of
Operations |
(in thousands, except share and per share
data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
For the Three Months Ended June 30, |
|
For the Six Months Ended June 30, |
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
3,808 |
|
|
$ |
8,589 |
|
|
$ |
8,454 |
|
|
$ |
17,717 |
|
General and administrative |
|
2,751 |
|
|
|
2,746 |
|
|
|
5,629 |
|
|
|
5,177 |
|
Total operating expenses |
|
6,559 |
|
|
|
11,335 |
|
|
|
14,083 |
|
|
|
22,894 |
|
Other income (expense), net |
|
(417 |
) |
|
|
62 |
|
|
|
(478 |
) |
|
|
202 |
|
Net loss |
$ |
(6,976 |
) |
|
$ |
(11,273 |
) |
|
$ |
(14,561 |
) |
|
$ |
(22,692 |
) |
Net loss per share attributable
to common stockholders—basic and diluted |
$ |
(0.26 |
) |
|
$ |
(0.54 |
) |
|
$ |
(0.56 |
) |
|
$ |
(1.09 |
) |
Weighted-average common shares
outstanding—basic and diluted |
|
26,878,962 |
|
|
|
20,903,298 |
|
|
|
25,808,043 |
|
|
|
20,859,251 |
|
|
Investor Contact Hannah Deresiewicz Stern
Investor Relations, Inc.
212-362-1200hannah.deresiewicz@sternir.com
Media Contact Adam Daley Berry & Company
Public Relations 212-253-8881 adaley@berrypr.com
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