Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the
Company) announced today that the Company has entered into
agreements for an additional $100 million in capital between two
transactions with funds associated with Patient Square Capital and
HealthCare Royalty (HCRx), respectively.
On January 4, 2024, Liquidia and an affiliate of Patient Square
Capital entered into a common stock purchase agreement for the
private placement of 7,182,532 shares of common stock at a
purchase price of $10.442 per share. The price per share represents
an 8% discount to the closing price on January 3, 2024. The private
placement is expected to close January 8, 2024, and yield gross
proceeds of approximately $75.0 million. No broker fees were paid
in connection with the private placement.
On January 3, 2024, HCRx and Liquidia entered a fourth amendment
to the Revenue Interest Financing Agreement (RIFA) to fund an
additional $25.0 million. HCRx has now invested $67.5 million in
non-dilutive capital from the $100 million originally contemplated
from four tranches under the RIFA. The fourth amendment moves $25.0
million from the third tranche to the second tranche, such that
HCRx has funded a total of $35.0 million under the second tranche.
The remaining third tranche of $10.0 million and fourth tranche of
$22.5 million can be funded in the future upon the mutual agreement
of both HCRx and Liquidia. As consideration for the invested
amount, Liquidia has agreed to increase fixed payments due to HCRx
on a pro rata basis in proportion to the additional capital
advanced. If the third tranche is funded, the payment schedule
would change to a tiered royalty on the Company’s annual net
revenue after the first commercial sale of YUTREPIATM
(treprostinil) inhalation powder.
Michael Kaseta, Chief Financial Officer of Liquidia, stated:
“With these financings, we are well positioned to achieve our
corporate objectives in 2024 and could bridge the Company to
profitability if YUTREPIA is able to launch by April. We
believe that the investments by Patient Square Capital and HCRx
signal the increasing confidence in our strategy, the outcomes of
on-going litigation, and more importantly, the value of YUTREPIA to
the medical community who are seeking new choices to treat patients
diagnosed with pulmonary arterial hypertension (PAH) and pulmonary
hypertension associated with interstitial lung disease
(PH-ILD).”
In the last month, Liquidia has secured a total of $126 million
in total gross proceeds from the sum of today’s financings plus the
previously announced underwritten public offering and private
placement that closed on December 14, 2023.
About Patient Square Capital
Patient Square Capital is a dedicated health care investment
firm with more than $7.5 billion in assets under management as of
September 30, 2023. The firm partners with best-in-class management
teams whose products, services and technologies improve health.
Patient Square Capital utilizes deep industry expertise, a broad
network of relationships and a partnership approach to make
investments in companies grow and thrive. Patient Square Capital
invests in businesses that strive to improve patient lives,
strengthen communities, and create a healthier world. For more
information, visit www.patientsquarecapital.com.
About HealthCare Royalty
HCRx is a leading royalty acquisition company focused on
commercial or near-commercial stage biopharmaceutical products.
HCRx has invested $5+ billion in over 85 biopharmaceutical products
since inception with offices in Stamford (CT), San Francisco,
Boston and London. For more information, visit
https://www.hcrx.com/. HEALTHCARE ROYALTY® and HCRx® are registered
trademarks of HealthCare Royalty Management, LLC.
About YUTREPIA™(treprostinil) inhalation
powder
YUTREPIA is an investigational, inhaled dry powder formulation
of treprostinil delivered through a convenient, low-resistance,
palm-sized device. On November 5, 2021, the FDA issued a tentative
approval for YUTREPIA for the treatment of PAH to improve exercise
ability in adult patients with New York Heart Association (NYHA)
Functional Class II-III symptoms. In July 2023, Liquidia filed an
amendment to its New Drug Application for YUTREPIA, seeking to add
PH-ILD to the label. The FDA has set a Prescription Drug User Fee
Act (PDUFA) goal date of January 24, 2024 for the amendment.
Previously, the FDA has confirmed that YUTREPIA may add the
treatment of PH-ILD to the label for YUTREPIA without additional
clinical studies. YUTREPIA was designed using Liquidia’s PRINT®
technology, which enables the development of drug particles that
are precise and uniform in size, shape, and composition, and that
are engineered for enhanced deposition in the lung following oral
inhalation. Liquidia has completed INSPIRE, or Investigation of the
Safety and Pharmacology of Dry Powder Inhalation of Treprostinil,
an open-label, multi-center phase 3 clinical study of YUTREPIA in
patients diagnosed with PAH who are naïve to inhaled treprostinil
or who are transitioning from Tyvaso® (nebulized treprostinil).
YUTREPIA was previously referred to as LIQ861 in investigational
studies.
About pulmonary arterial hypertension (PAH)
Pulmonary arterial hypertension (PAH) is a rare, chronic,
progressive disease caused by hardening and narrowing of the
pulmonary arteries that can lead to right heart failure and
eventually death. Currently, an estimated 45,000 patients are
diagnosed and treated in the United States. There is currently no
cure for PAH, so the goals of existing treatments are to alleviate
symptoms, maintain or improve functional class, delay disease
progression, and improve quality of life.
About pulmonary hypertension associated with
interstitial lung disease (PH-ILD)
Pulmonary hypertension (PH) associated with interstitial lung
disease (ILD) includes a diverse collection of up to 150 different
pulmonary diseases, including interstitial pulmonary fibrosis,
chronic hypersensitivity pneumonitis, connective tissue disease
related ILD, and chronic pulmonary fibrosis with emphysema (CPFE)
among others. Any level of PH in ILD patients is associated with
poor 3-year survival. A current estimate of PH-ILD prevalence in
the United States is greater than 60,000 patients, though
population growth in many of these underlying ILD diseases is not
yet known due to factors including underdiagnosis and lack of
approved treatments until March 2021, when inhaled treprostinil was
first approved for this indication.
About Liquidia Corporation
Liquidia Corporation is a biopharmaceutical company focused on
the development and commercialization of products in pulmonary
hypertension and other applications of its PRINT® Technology. The
Company operates through its two wholly owned subsidiaries,
Liquidia Technologies, Inc. and Liquidia PAH, LLC. Liquidia
Technologies has developed YUTREPIA™ (treprostinil) inhalation
powder for the treatment of pulmonary arterial hypertension (PAH)
and pulmonary hypertension associated with interstitial lung
disease (PH-ILD). Liquidia Technologies is also developing L606, an
investigational liposomal formulation of treprostinil administered
twice-daily with a short-duration next-generation nebulizer, for
use in North America. Liquidia PAH provides the commercialization
for pharmaceutical products to treat pulmonary disease, such as
generic Treprostinil Injection. For more information, please visit
www.liquidia.com.
Tyvaso® and Tyvaso DPI® are registered trademarks of United
Therapeutics Corporation.
Cautionary Statements Regarding Forward-Looking
StatementsThis press release may include forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. All statements contained in this press release
other than statements of historical facts, including statements
regarding our future results of operations and financial position,
our strategic and financial initiatives, our business strategy and
plans and our objectives for future operations, are forward-looking
statements. Such forward-looking statements, including statements
regarding clinical trials, clinical studies and other clinical work
(including the funding therefor, anticipated patient enrollment,
safety data, study data, trial outcomes, timing or associated
costs), regulatory applications and related submission contents and
timelines, including the potential for final FDA approval of the
NDA for YUTREPIA, the timeline or outcome related to patent
litigation in the U.S. District Court for the District of Delaware
or inter partes review proceedings conducted at the PTAB, including
appeals of decisions in any such proceedings, the issuance of
patents by the USPTO and our ability to execute on our strategic or
financial initiatives, involve significant risks and uncertainties
and actual results could differ materially from those expressed or
implied herein. The favorable decisions of lower tribunals are not
determinative of the outcome of the appeals of the decisions. The
words “anticipate,” “believe,” “continue,” “could,” “estimate,”
“expect,” “intend,” “may,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “would,” and similar expressions are
intended to identify forward-looking statements. We have based
these forward-looking statements largely on our current
expectations and projections about future events and financial
trends that we believe may affect our financial condition, results
of operations, business strategy, short-term and long-term business
operations and objectives and financial needs. These
forward-looking statements are subject to a number of risks
discussed in our filings with the SEC, including the impact of the
coronavirus (COVID-19) outbreak on our Company and our financial
condition and results of operations, as well as a number of
uncertainties and assumptions. Moreover, we operate in a very
competitive and rapidly changing environment and our industry has
inherent risks. New risks emerge from time to time. It is not
possible for our management to predict all risks, nor can we assess
the impact of all factors on our business or the extent to which
any factor, or combination of factors, may cause actual results to
differ materially from those contained in any forward-looking
statements we may make. In light of these risks, uncertainties and
assumptions, the future events discussed in this press release may
not occur and actual results could differ materially and adversely
from those anticipated or implied in the forward-looking
statements. Nothing in this press release should be regarded as a
representation by any person that these goals will be achieved, and
we undertake no duty to update our goals or to update or alter any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Contact Information
Media & Investors:Jason AdairChief Business
Officer919.328.4400jason.adair@liquidia.com
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