Item 2.02. Results of Operations and Financial Condition.
The disclosure set forth in Item 8.01 regarding the Company's approximate cash
and cash equivalents as of
Item 8.01. Other Events.
On
Clinical Update on ALLN-346
Our product candidate ALLN-346 is an orally administered, novel, urate degrading
enzyme for patients with hyperuricemia and gout in the setting of advanced
chronic kidney disease (CKD). We have conducted a Phase 1 program, including
both a single-ascending dose and multiple-ascending dose study in healthy
volunteers. In both studies, ALLN-346 was well tolerated with no clinically
significant safety signals and no dose-limiting toxicities observed in any
cohort up to the highest administered dose. We are currently conducting two
Phase 2a studies. Study 201 is a 7-day inpatient study in patients with
hyperuricemia, for which we reported preliminary topline data in
Study 202 is a 14-day outpatient study in patients with hyperuricemia, gout and varying degrees of renal insufficiency. In this study, patients are randomized (2:1) to receive either five capsules of ALLN-346 or a matching placebo three times daily, with enrollment of up to four planned cohorts, each consisting of approximately 12 patients. Cohort A is comprised of patients considered to have Stage 2, or mild CKD, and cohort B is comprised of patients considered to have Stage 3, or moderate CKD. We currently expect to announce preliminary topline from these two cohorts during the third quarter of 2022.
If we successfully complete Cohorts A and B of Study 202 and are able to secure adequate additional financing, we plan to open two additional cohorts in Study 202 later in 2022, consisting of patients with Stage 4, or advanced CKD (Cohort C), and an allopurinol combination therapy cohort in Stage 3 CKD patients (Cohort D). If we successfully complete Cohorts A and B of Study 202 and are able to secure adequate additional financing, we currently expect that we would be in a position to announce preliminary topline data from the first group of patients treated in these two cohorts by early 2023.
Update on Our Loan Agreement With Pontifax
We are party to a loan and security agreement with
As previously disclosed, because of our limited cash resources and the recent
termination of our Phase 3 clinical trial of reloxaliase, we have had
discussions with Pontifax, regarding the potential repayment of our outstanding
borrowing under our loan agreement with Pontifax. In
In
The obligations under the Pontifax Agreement are subject to acceleration upon occurrence of specified events of default, including a material adverse change in our business, operations or financial or other condition. As previously disclosed, due to our current financial and operating position, we have classified the Pontifax loan balance as a current liability on our balance sheet.
Update on Our Financial Position
We have identified conditions and events that raise substantial doubt about our ability to continue operations in the near-term. We may need to seek an in-court or out-of-court restructuring of our liabilities.
We may be forced to amend, delay, limit, reduce or terminate the scope of our
development program for ALLN-346 and/or limit or cease our operations if we are
unable to obtain additional funding. As of
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Forward-Looking Statements
This Current Report on Form 8-K release contains "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act of 1995,
including, without limitation, statements concerning the future clinical,
regulatory and commercial potential of ALLN-346; statements regarding Allena's
development of ALLN-346 including the timing of planned clinical trials and the
announcement of topline data for these trials; and statements regarding Allena's
financial position and need for capital. 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. Additional risks and uncertainties include, but
are not limited to: market and other conditions, the timing for completion of
Allena's clinical trials of its product candidates, 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; risks associated with
Allena's financial condition and its need to obtain additional funding to
support its business activities, including the future clinical development of
ALLN-346, and its ability to continue as a going concern; risks associated with
Allena's dependence on third parties; risks related to the COVID-19 coronavirus;
risks associated with Allena's ability to identify and consummate financing and
strategic alternatives that yield additional value for shareholders; the timing,
benefits and outcome of the Allena's strategic alternatives review process,
including the determination of whether or not to pursue or consummate any
strategic alternative, the structure, terms and specific risks and uncertainties
associated with any potential strategic transaction, potential disruptions in
Allena's business and stock price as a result of its exploration, review and
pursuit of strategic alternatives or the public announcement thereof and any
decision or transaction resulting from such review. 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 Allena's Quarterly Report
on Form 10-Q for the quarter ended
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits. Exhibit Number Description 104 Cover Page Interactive Data File (Embedded within the Inline XBRL Document).
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