Allena Pharmaceuticals Announces $10.0 Million Bought Deal Offering
02 December 2020 - 9:00AM
Allena Pharmaceuticals, Inc. (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,
announced today that it has entered into an underwriting agreement
with H.C. Wainwright & Co., LLC under which the underwriter has
agreed to purchase on a firm commitment basis 8,000,000 shares of
common stock of the Company, at a price to the public of $1.25 per
share, less underwriting discounts and commissions. The closing of
the offering is expected to occur on or about December 4, 2020,
subject to satisfaction of customary closing conditions.
H.C. Wainwright & Co. is acting as the sole book-running
manager for the offering.
The Company also has granted to the underwriter a 30-day option
to purchase up to an additional 1,200,000 shares of common stock at
the public offering price, less underwriting discounts and
commissions. The gross proceeds to Allena, before deducting
underwriting discounts and commissions and offering expenses and
assuming no exercise of the underwriter’s option to purchase
additional common stock, are expected to be approximately $10.0
million. The Company intends to use the net proceeds from this
offering for working capital and other general corporate
purposes.
The shares of common stock are being offered by the Company
pursuant to a “shelf” registration statement on Form S-3 (File No.
333-228656) previously filed with the Securities and Exchange
Commission (the “SEC”) on December 3, 2018, and declared effective
by the SEC on December 26, 2018. The offering of the shares of
common stock is made only by means of a prospectus, including a
prospectus supplement, forming a part of the effective registration
statement. A preliminary prospectus supplement and accompanying
prospectus relating to, and describing the terms of, the offering
will be filed with the SEC and will be available on the SEC’s
website at http://www.sec.gov. Electronic copies of the preliminary
prospectus supplement and accompanying prospectus may also be
obtained, when available, by contacting H.C. Wainwright & Co.,
LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone
at (646) 975-6996 or e-mail at placements@hcwco.com.
This press release shall not constitute an offer to sell or a
solicitation of an offer to buy these securities, nor shall there
be any sale of these securities in any state or other jurisdiction
in which such offer, solicitation or sale would be unlawful prior
to the registration or qualification under the securities laws of
any such state or other jurisdiction.
About Allena PharmaceuticalsAllena
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 currently being evaluated in a pivotal Phase 3
clinical program for the treatment of enteric 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. Allena is also
developing ALLN-346 for the treatment of hyperuricemia in the
setting of gout and advanced chronic kidney disease, with a Phase
1b multiple-ascending dose study and a Phase 2 proof-of-concept
study planned for 2021.
Forward-Looking StatementsThis release contains
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995, including, without
limitation, statements regarding the completion of the public
offering, the satisfaction of customary closing conditions related
to the public offering and the intended use of net proceeds from
the public offering, 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: market and other
conditions, 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 September 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.
Investor ContactHannah DeresiewiczStern
Investor Relations,
Inc.212-362-1200hannah.deresiewicz@sternir.com
Media ContactAdam Daley Berry & Company
Public Relations 212-253-8881adaley@berrypr.com
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