Full Press Release Details
Liquidia Corporation Announces Raise of $67.5
Million from New Common Stock Financings and $32.5
Million Advance from HealthCare Royalty Under Current Financing Agreement
N.C., September 11, 2024 - Liquidia Corporation (NASDAQ: LQDA) (the "Company" or "Liquidia"),
a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary diseases, announced today the pricing
of an underwritten public offering and a concurrent private placement, with anticipated total gross proceeds of approximately $67.5 million,
before deducting underwriting discounts and commissions, and expenses.
The Company offered 6,460,674 shares of common stock in the
public offering at a price of $8.90 per share. In addition, Liquidia entered into a common stock purchase agreement with funds
managed by Caligan Partners LP for the sale of 1,123,595 shares of common stock at a purchase price of $8.90 per share in a private
placement exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act").
The closing of the public offering is not conditioned upon the closing of the private placement, but the closing of the private
placement is conditioned upon the closing of the public offering. The public offering and concurrent private placement are expected
to close on September 12, 2024, subject to other customary closing conditions.
BofA Securities acted as the sole book-running manager for the
public offering, LifeSci Capital acted as lead manager for the public offering and Needham & Company acted as co-manager
for the public offering.
Liquidia also announced today that the Company has entered into a
fifth amendment to the Revenue Interest Financing Agreement ("RIFA") with HealthCare Royalty ("HCRx") to
fund an additional $32.5 million (the "Fifth Amendment"), subject to certain closing conditions including the funding condition discussed further below. With this amendment,
HCRx will have invested the full $100 million in non-dilutive capital as originally contemplated under the RIFA entered in
The Fifth Amendment proceeds, together with the public offering
and concurrent private placement proceeds, aggregate to total gross proceeds of approximately $100 million before deducting
applicable underwriting discounts, commissions, and expenses. Net proceeds from the public offering, the concurrent private
placement and the Fifth Amendment are expected to fund ongoing commercial development of YUTREPIA (treprostinil) inhalation
powder for the potential treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial
lung disease (PH-ILD), continued development of YUTREPIA in other clinical trials, including but not limited to trials for pediatric
patients and trials further evaluating the use of YUTREPIA in WHO Group 1 and WHO Group 3 patients, clinical development of L606 and
for general corporate purposes.
Michael Kaseta, Chief Financial Officer and Chief Operating Officer
of Liquidia, stated: "We are excited by HealthCare Royalty's continued commitment and confidence in our ability to bring
new treatment options to market for patients with rare cardiopulmonary diseases. We believe we are financially well-positioned to continue
ongoing commercial development of YUTREPIA in anticipation of potential final regulatory approval, to progress development of YUTREPIA
in other clinical trials like ASCENT for PH-ILD, and to advance L606 (liposomal treprostinil) inhalation suspension into a global pivotal
Clarke Futch, Chairman and Chief Executive Officer of HCRx added: "We
view the recent grant of tentative approval of YUTREPIA to treat both PAH and PH-ILD as a significant milestone for the company. More
importantly, we are confident in Liquidia's potential to address the needs of patients suffering from rare cardiopulmonary diseases.
We are excited to see how YUTREPIA may help change the lives of patients upon final approval and launch potentially in 2025."
The Fifth Amendment to the RIFA moves the additional $32.5 million
that was funded from the third and fourth tranches to the second tranche such that, following the closing of the Fifth Amendment and the
funding of the remaining $32.5 million, HCRx will have funded a total of $67.5 million under the second tranche and each of the third
and fourth tranches will be eliminated. As a result, the Company will continue to pay HCRx on a fixed payment schedule and will not change
to a tiered royalty on the Company's annual net revenue after the first commercial sale of YUTREPIA. As consideration for the additional
invested amount, Liquidia has agreed to a modified fixed payment schedule that extends expected termination of the RIFA from 2029 to 2031.
HCRx also agreed to defer a one-time fixed payment of $23.8 million that was originally due on July 30, 2025, into two equal payments
due in January 2026 and July 2026. The aggregate payments to HCRx are capped at 175% of the total amounts advanced by HCRx,
but also include a potential true-up payment to be made by Liquidia if HCRx's internal rate of return is less than a threshold value
on the date the cap is reached. The threshold value for the newly advanced funds is 16% as compared to the 18% for the previously advanced
funds. Funding of the additional $32.5 million under the second tranche is conditioned upon Liquidia receiving not less than $50.0 million
in aggregate gross proceeds from the sale of the Company's common stock in one or more transactions. Upon closing of the public
offering and concurrent private placement, this funding condition will be satisfied. The closing of the public offering and concurrent
private placement are each subject to customary closing conditions.
The shares of common stock in the public offering described above were
offered by Liquidia pursuant to its shelf registration statement on Form S-3, including a base prospectus, that was previously filed
by Liquidia with the Securities and Exchange Commission (the "SEC") on December 22, 2023, and declared effective by the
SEC on January 3, 2024. The public offering was made by means of a written prospectus and prospectus supplement that formed part
of the registration statement. A final prospectus supplement and the accompanying prospectus relating to and describing the terms of the
public offering will be filed with the SEC and will be available at the SEC's website located at www.sec.gov. Copies of the final
prospectus supplement and the accompanying prospectus relating to the offering may be obtained from BofA Securities, Attention: Prospectus
Department, NC1-022-02-25, 201 North Tryon Street, Charlotte, North Carolina 28255, or via email: dg.prospectus_requests@bofa.com.
The shares of common stock to be sold in the concurrent private placement
have not been registered under the Securities Act or under any state securities laws and, unless so registered, may not be offered or
sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the
Securities Act and applicable state securities laws.
This press release shall not constitute an offer to sell or the solicitation
of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which
such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state
About Liquidia Corporation
Liquidia Corporation is a biopharmaceutical company developing
innovative therapies for patients with rare cardiopulmonary diseases. The company's current focus spans the development and commercialization
of products in pulmonary hypertension and other applications of its proprietary PRINT Technology. PRINT enabled
the creation of Liquidia's lead candidate, YUTREPIA (treprostinil) inhalation powder, an investigational drug for the treatment
of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company
is also developing L606, an investigational sustained-release formulation of treprostinil administered twice-daily with a next-generation
nebulizer, and currently markets generic Treprostinil Injection for the treatment of PAH.
Tyvaso and Tyvaso DPI are registered trademarks of United
Therapeutics Corporation.
About YUTREPIA (treprostinil) Inhalation Powder
YUTREPIA is an investigational, inhaled dry-powder formulation of treprostinil
delivered through a convenient, low-effort, palm-sized device. 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 na ve to inhaled treprostinil or who are transitioning from Tyvaso (nebulized treprostinil). YUTREPIA is currently being
studied in the ASCENT trial, an Open-Label Prospective Multicenter Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil
in Pulmonary Hypertension, with the objective of informing YUTREPIA's dosing and tolerability profile in patients with PH-ILD. YUTREPIA
was previously referred to as LIQ861 in investigational studies.
Cautionary Statements Regarding Forward-Looking Statements
This 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 include statements regarding the closing of the public offering, the concurrent private placement and the funding under the
Fifth Amendment; the intended use of proceeds from these transactions; our plans 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 potential for and timing of commercial launch of YUTREPIA; the potential benefits of YUTREPIA for patients; 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 words "anticipate," "believe," "continue,"
"could," "estimate," "expect," "intend," "may," "plan," "potential,"