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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
Date of Report (Date of earliest event reported):
October 8, 2026
| LIQUIDIA
CORPORATION |
| (Exact name
of registrant as specified in its charter) |
| |
|
|
| Delaware |
001-39724 |
85-1710962 |
(State or other jurisdiction
of incorporation) |
(Commission
File Number) |
(IRS Employer
Identification No.) |
| 419
Davis Drive, Suite
100, Morrisville,
North Carolina |
27560 |
| (Address of principal executive
offices) |
(Zip Code) |
Registrant’s telephone number, including
area code: (919) 328-4400
| (Former
name or former address, if changed since last report.) |
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see
General Instruction A.2. below):
¨
Written communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
¨
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange
Act (17 CFR 240.14d-2(b))
¨
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange
Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Title
of each class |
Trading
Symbol(s) |
Name
of each exchange on which registered |
| Common
stock |
LQDA |
The
Nasdaq
Stock Market LLC |
Indicate by check mark whether the registrant is
an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the
Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ¨
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 1.01 Entry into a Material Definitive Agreement.
Settlement Agreement
On October 13, 2026 (the “Effective Date”), Liquidia Technologies,
Inc., a Delaware corporation (the “Company”), a wholly-owned subsidiary of Liquidia Corporation, and United Therapeutics Corporation
(“UTC”) entered into a settlement agreement (the “Settlement Agreement”) regarding all ongoing litigation between
the Company and UTC, including, among other matters, the resolution of pending patent infringement litigations relating to U.S. Patent
No. 11,824,327, U.S. Patent No. 11,357,782 and U.S. Patent No. 10,989,494 and the trade secret and breach of contract litigation pending
in the North Carolina Business Court (collectively, the “Litigations”).
Under the terms of the Settlement Agreement, the Company will continue
to market, sell and promote YUTREPIA® (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension
(“PAH”). In exchange, the Company will (a) file with the U.S. Food and Drug Administration (“FDA”) to amend the
current product label of YUTREPIA® to remove pulmonary hypertension associated with interstitial lung disease (“PH-ILD”)
as an indicated treatment as well as any reference to PH-ILD, (b) immediately and permanently cease, desist, and terminate any and all
activities relating to the marketing, advertising, promotion, and detailing of YUTREPIA® for the treatment of PH-ILD, and
(c) (i) make a net payment to UTC of $175.0 million, due within thirty (30) business days of the Effective Date after taking into account
payment by UTC to the Company to settle its ongoing litigation with Liquidia PAH, LLC, a Delaware limited liability company (“Liquidia
PAH”) and wholly owned subsidiary of the Company, formerly known as RareGen, LLC (“RareGen”), and (ii) make a payment
to UTC of an aggregate of $145.4 million, to be paid in two equal installments on or before January 31, 2027 and April 30, 2027, respectively
(such payments, collectively, the “UTC Payments”).
The Settlement
Agreement also provides that each party releases the other party and their respective affiliates from any claims arising at any
time up to and including the Effective Date, including relating to the Litigations (the “Releases”). The Settlement Agreement
became effective upon execution, but the Releases will become effective only upon the satisfaction of certain conditions, including (a)
the Company’s payment of the UTC Payments, (b) the filing of dismissals with prejudice of the Litigations with the applicable courts,
and (c) the Company’s receipt of FDA approval to remove the PH-ILD indication from YUTREPIA’s® product label.
In addition, the Settlement Agreement contains customary covenants not to sue the other party in certain circumstances and provides for
the dismissal of the Litigations with prejudice. Each party will continue to bear its own costs, expenses and attorneys’ fees in
connection with the Litigations and the negotiation and execution of the Settlement Agreement.
As a requirement under the Settlement Agreement, the Company was required
to secure a settlement of the antitrust and breach of contract proceedings brought by Sandoz and Liquidia PAH against UTC and Smiths Medical
ASD, Inc. (the “RareGen Litigation”). Accordingly, the Company entered into agreements with each of Sandoz Inc. (“Sandoz”),
Henderson SPV, LLC (“Henderson”) and PBM RG Holdings, LLC (“PBM”), who have interests in the RareGen Litigation,
as described below.
Sandoz Agreement
On October 11, 2026, the Company entered into a Settlement and Termination
Agreement with Sandoz (the “Sandoz Agreement”) to settle Sandoz’s entitlement to a fifty percent (50%) share of the
proceeds from the RareGen Litigation pursuant to that certain Promotion Agreement, dated as of August 1, 2018 (the “Promotion Agreement”),
by and between Sandoz and RareGen. Under the Sandoz Agreement, Liquidia Technologies will make a payment of $21.75 million (the “Sandoz
Payment”) into escrow no later than three (3) business days after the date of the Sandoz Agreement, which amount will be released
to Sandoz upon Sandoz’s delivery into escrow of the documents necessary to dismiss the RareGen Litigation with prejudice and the
entry by the Company and/or its affiliates into the Settlement Agreement. Upon payment of the Sandoz Payment to Sandoz, Sandoz’s
entire interest in the RareGen Litigation will be assigned to Liquidia Technologies, the Promotion Agreement will terminate, except for
certain other payment obligations owed by Sandoz to Liquidia PAH with respect to activities conducted during the third quarter of 2026,
and Liquidia Technologies will have the sole and exclusive right to control the RareGen Litigation for the purpose of effecting its dismissal
with prejudice, with each party bearing its own attorneys’ fees, costs and expenses.
Henderson Agreement
Additionally, on October 8, 2026, Liquidia Technologies and Liquidia
PAH entered into a Settlement and Termination Agreement with Henderson (the “Henderson Agreement”), which fixes the amount
payable to Henderson in complete satisfaction of its economic rights under that certain Litigation Financing Agreement, dated as of June
4, 2020, by and between Henderson and RareGen, pursuant to which Henderson funded a portion of Liquidia PAH’s legal and litigation
expenses in the RareGen Litigation in exchange for a share of certain litigation or settlement proceeds (the “Financing Agreement”).
Under the Henderson Agreement, Liquidia Technologies and Liquidia PAH are jointly and severally obligated to pay Henderson $19.05 million
(the “Henderson Payment”) no later than three (3) business days after the Company and/or its affiliates enter into the Settlement
Agreement. The Financing Agreement, and all of Henderson’s related rights, remedies, claims, liens and priorities, remain in full
force and effect until that amount is paid in full to Henderson, at which time the Financing Agreement will terminate. The Henderson Agreement
will also terminate if the Settlement Agreement is not executed or does not include a settlement of the RareGen Litigation.
PBM Agreement
Also, on October 10, 2026, Liquidia Technologies and Liquidia PAH entered
into a Settlement and Termination Agreement with PBM (the “PBM Agreement”), which fixes the amount payable to PBM in complete
satisfaction of its economic rights under the Litigation Funding and Indemnification Agreement, dated as of November 17, 2020 (the “Indemnification
Agreement”), by and between PBM and RareGen, under which PBM controls the RareGen Litigation, reimburses Liquidia PAH’s litigation
expenses not reimbursed by Henderson and is entitled to the proceeds of the RareGen Litigation to which Henderson is not entitled. Under
the PBM Agreement, Liquidia Technologies and Liquidia PAH are jointly and severally obligated to pay PBM $19.45 million (the “PBM
Payment” and together with the UTC Payments, the Sandoz Payment and the Henderson Payment, the “Settlement Payments”)
no later than three (3) business days after the Company and/or its affiliates enter into the Settlement Agreement with UTC, which payment
will constitute full payment of all amounts owing to PBM under the Indemnification Agreement, and the Indemnification Agreement will terminate
upon receipt of that payment, other than provisions that expressly survive termination. PBM is a related party of the Company because
it is controlled by Paul B. Manning, a stockholder of the Company who beneficially owns at least five percent (5%) of the Company’s
outstanding common stock and is also a member of the Company’s Board of Directors (the “Board”), and it is also owned
by Roger Jeffs, the Company’s Chief Executive Officer and a member of the Board, Damian deGoa, a member of the Board, and Russell
Schundler, the Company’s General Counsel. The PBM Agreement was reviewed and approved by the disinterested members of the Board.
Seventh Amendment to Revenue Interest Financing Agreement
As previously disclosed, on January 9, 2023, the Company, entered into
a Revenue Interest Financing Agreement with HealthCare Royalty Partners IV, L.P. (“HCR”), as amended by that certain First
Amendment to Revenue Interest Financing Agreement, dated as of April 17, 2023, as amended by that certain Second Amendment to Revenue
Interest Financing Agreement, dated as of June 28, 2023, as amended by that certain Third Amendment to Revenue Interest Financing Agreement,
dated as of July 27, 2023, as amended by that certain Fourth Amendment to Revenue Interest Financing Agreement, dated as of January 3,
2024, as amended by that certain Fifth Amendment to Revenue Interest Financing Agreement, dated as of September 11, 2024, and as further
amended by that certain Sixth Amendment to Revenue Interest Financing Agreement, dated as of March 17, 2025 (as amended, the “Financing
Agreement”).
On October 13, 2026, the Company and HCR entered into a Seventh Amendment
to the Financing Agreement (the “Seventh Amendment”), pursuant to which HCR agreed to provide its consent for the Company
to enter into a letter of credit with a third-party lender in connection with the Settlement Agreement. As consideration for such consent,
the Company has agreed to increase the minimum cash covenant under the Financing Agreement from $15.0 million to $45.0 million.
The foregoing descriptions of certain terms of the Settlement Agreement,
the Sandoz Agreement, the Henderson Agreement, the PBM Agreement and the Seventh Amendment do not purport to be complete, are intended
to be summaries of the material terms of such agreements and each is qualified in its entirety by reference to the complete text of each
such agreement, which are filed hereto as Exhibit 10.1, Exhibit 10.2, Exhibit 10.3, Exhibit 10.4 and Exhibit 10.5 respectively.
Item 1.02 Termination of a Material Definitive Agreement.
The information set forth in Item 1.01 of this Current Report on Form
8-K regarding the Sandoz Agreement, the Henderson Agreement and the PBM Agreement is incorporated by reference into this Item 1.02. Each
such agreement provides for the termination, in whole or in part, of an existing agreement to which one or more of the Company’s
subsidiaries is a party. None of the terminations described below are effective upon execution of the applicable settlement and termination
agreement. In each case, the termination occurs only upon payment of the applicable settlement amount in full, and in the case of the
Promotion Agreement, only after the Sandoz Agreement has become effective in accordance with its terms.
Promotion Agreement
Under the Promotion Agreement, Liquidia PAH conducts promotional and
related commercial activities for Sandoz’s generic treprostinil injection (“Treprostinil Injection”) in the United States
in exchange for a tiered share of net profits from sales of Treprostinil Injection, and all proceeds of the RareGen Litigation are divided
evenly between Sandoz and Liquidia PAH. Under the Sandoz Agreement, the Promotion Agreement will terminate with respect to the RareGen
Litigation upon payment of the Sandoz Payment to Sandoz, except for certain other payment obligations owed by Sandoz to Liquidia PAH with
respect to activities during the third quarter of 2026.
Financing Agreement
Under the Financing Agreement, Henderson funded $10.0 million of Liquidia
PAH’s legal and litigation expenses in the RareGen Litigation in exchange for a share of certain litigation or settlement proceeds,
and Henderson holds liens on, and priority rights in, those proceeds. Under the Henderson Agreement, the Financing Agreement will terminate
upon payment of the Henderson Payment to Henderson, which will constitute full payment of all amounts owing to Henderson under the Financing
Agreement.
Indemnification Agreement
Under the Indemnification Agreement, PBM retains the sole and exclusive
right to control the RareGen Litigation, funds the counsel fees and litigation expenses of Liquidia PAH that are not funded by Henderson,
is entitled to the litigation proceeds remaining after amounts payable to Henderson, and holds a security interest in the rights of Liquidia
PAH in the RareGen Litigation and the proceeds thereof that is subordinated to the security interest of Henderson. Further, the Indemnification
Agreement provides that Liquidia PAH and its affiliates are not entitled to any proceeds of, and do not bear any financial or other liability
for, the RareGen Litigation unless PBM defaults. Under the PBM Agreement, the Indemnification Agreement will terminate upon payment of
the PBM Payment to PBM, which will constitute full payment of all amounts owing to PBM under the Indemnification Agreement.
The foregoing descriptions of the termination provisions of the Sandoz
Agreement, the Henderson Agreement and the PBM Agreement, and of the Promotion Agreement, the Financing Agreement and the Indemnification
Agreement, do not purport to be complete and are qualified in their entirety by reference to the complete text of each such agreement.
Item 7.01 Regulation FD Disclosure.
As of September 30, 2026, the Company had cash and cash equivalents
of $396.1 million. Preliminary and unaudited results from the third quarter 2026 included YUTREPIA net product sales of $222.7 million.*
* The information in Item 7.01 of this Form 8-K shall not be deemed
“filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or
otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities
Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Cautionary Statements Regarding Forward-Looking Statements
This Current Report on Form 8-K may include forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report on Form 8-K
other than statements of historical facts, including statements regarding the settlement agreement and its anticipated benefits; the amount,
timing and funding of payments under the settlement agreement and the agreements with Sandoz Inc., Henderson SPV, LLC, and PBM RG Holdings,
LLC; the transfer of commercial rights related to Treprostinil Injection to Sandoz; the filing and entry of dismissals of the pending
litigation; the timing and outcome of FDA review of the Prior Approval Supplement to remove the PH-ILD indication from the YUTREPIA label;
the impact of ceasing PH-ILD promotion and sales on YUTREPIA revenue; continued availability of YUTREPIA for patients with PAH; our future
results of operations, financial position and cash resources; and our development plans for L606 and for YUTREPIA in SSc-RP, PH-COPD or
other indications, are forward-looking statements. These statements involve significant risks and uncertainties, and actual results could
differ materially from those expressed or implied herein. Among other things, the settlement agreement does not extend to indications
other than PAH or to new treprostinil-containing products, and United Therapeutics may assert patents against our development programs
or future products. Fast Track designation does not guarantee that YUTREPIA will receive FDA approval for the treatment of SSc-RP or that
development will proceed on the anticipated timeline. 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, 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 Current Report on Form 8-K may
not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.
Nothing in this Current Report on Form 8-K 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.
The estimated preliminary unaudited financial information for the period
ended September 30, 2026 included in this Current Report on Form 8-K may contain forward-looking statements that are based on information
available to the Company as of the date of this report. The Company’s financial closing and review procedures for the period ended
September 30, 2026 are not yet complete, and actual results may differ from these preliminary estimates as a result of final accounting
adjustments, the completion of internal control processes, and other developments that may arise prior to the finalization of the Company’s
financial statements. The preliminary financial information included in this release have not been reviewed by the Company’s independent
registered public accounting firm and should not be considered a substitute for the Company’s unaudited interim financial statements.
Accordingly, undue reliance should not be placed on this preliminary information.
Item 8.01 Other Events.
On October 13, 2026, Liquidia Corporation, a Delaware corporation,
issued a press release regarding the entry into the Settlement Agreement with UTC in connection with the resolution of all ongoing litigation
between the Company and UTC, and the concurrent entry into the Sandoz Agreement, the Henderson Agreement and the PBM Agreement with the
respective parties named therein to secure a settlement of the antitrust and breach of contract proceedings related to the RareGen Litigation,
as required under the Settlement Agreement. A copy of the press release is filed as Exhibit 99.1 hereto and is incorporated by reference
into this Item 8.01.
Item 9.01 Financial Statements and Exhibits.
(d)
Exhibit
No. |
|
Exhibit |
| 10.1 |
|
Settlement Agreement, dated as of October 13, 2026,
by and between Liquidia Technologies, Inc. and United Therapeutics Corporation. |
| 10.2 |
|
Settlement and Termination Agreement, dated as of October
11, 2026, by and between Liquidia Technologies, Inc. and Sandoz Inc. |
| 10.3 |
|
Settlement and Termination Agreement, dated as of October
8, 2026, by and among Liquidia Technologies, Inc., Liquidia PAH, LLC and Henderson SPV, LLC. |
| 10.4 |
|
Settlement and Termination Agreement, dated as of October
10, 2026, by and among Liquidia Technologies, Inc., Liquidia PAH, LLC and PBM RG Holdings, LLC. |
| 10.5 |
|
Seventh Amendment to Revenue Interest Financing Agreement,
dated as of October 13, 2026, by and between Liquidia Technologies, Inc. and Healthcare Royalty Partners IV, L.P. |
| 99.1 |
|
Press Release of Liquidia Corporation, dated as of
October 13, 2026. |
| 104 |
|
Cover Page Interactive Data File (embedded within the
Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| October 14, 2026 |
Liquidia Corporation |
| |
|
| |
By: |
/s/ Michael Kaseta |
| |
|
Name: Michael Kaseta |
| |
|
Title: Chief Financial Officer and Chief Operating Officer |
Exhibit 99.1
Liquidia Announces Global Settlement Resolving All Pending Litigation
with United Therapeutics, Ensuring Continued Commercialization of YUTREPIA in PAH
| · | Fully resolves all six ongoing lawsuits between the companies |
| · | Maintains uninterrupted access to YUTREPIA® for patients with pulmonary arterial hypertension (PAH) |
| · | Liquidia to pay net $380.7 million in multiple installments in 2026 and 2027, inclusive of payments to resolve antitrust litigation
against United Therapeutics |
| · | Strong financial position with $222.7 million in Q3’26 YUTREPIA net product sales (preliminary, unaudited), contributing to
$396.1 million in cash and cash equivalents as of September 30, 2026 |
| · | Liquidia will continue to advance YUTREPIA and L606 clinical programs as previously outlined |
MORRISVILLE, N.C., Oct. 13, 2026 (GLOBE NEWSWIRE) -- Liquidia
Corporation (Nasdaq: LQDA), a biopharmaceutical company driven by science and compassion to revolutionize care for patients with challenging
respiratory and vascular diseases, today announced that it has entered into a global settlement agreement with United Therapeutics Corporation
(Nasdaq: UTHR) that resolves all pending litigation between the companies. Importantly, YUTREPIA® (treprostinil) inhalation powder
will remain available to patients with PAH without disruption.
Liquidia CEO Dr. Roger Jeffs said: “We are always guided by our
commitment to act in the best interests of patients in everything we do. Today’s agreement fully resolves years of litigation and
provides certainty to PAH patients that they can continue to access YUTREPIA, whose differentiated attributes have enabled its rapid adoption
by physicians and patients since launch. We can now focus our full attention and resources on further growing the YUTREPIA brand, with
the goal of making it the prostacyclin therapy of choice in PAH, whether patients are starting or switching from an inhaled therapy, transitioning
from an oral prostacyclin, or de-escalating from parenteral prostacyclin to inhaled. And simultaneously, we will continue to build on
our market position through post-marketing studies of YUTREPIA, pivotal studies of L606 to support PAH and PH-ILD indications, and new
studies to explore novel treatments for conditions like systemic sclerosis-associated Raynaud's phenomenon (SSc-RP) and pulmonary hypertension
associated with chronic obstructive pulmonary disease (PH-COPD), where no approved options exist.”
Litigation Fully Resolved
The settlement follows the September 30, 2026, ruling by the U.S. District
Court for the District of Delaware (the Court) that claims 1 and 14 of U.S. Patent No. 11,826,327 (the ’327 patent) are valid and
infringed by Liquidia. These claims generally cover treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD)
with inhaled treprostinil, including dry powder formulations. As part of the settlement, Liquidia has agreed not to appeal the Court’s
ruling. In addition, Liquidia has submitted a supplement to remove the PH-ILD indication from YUTREPIA’s label and no longer promotes
it for PH-ILD.
The settlement includes mutual releases and is not an admission of
liability by either party. Following Liquidia’s initial payment, the parties will file stipulations to dismiss with prejudice the
following matters as between UTHR and Liquidia:
| · | United Therapeutics Corporation v. Liquidia Technologies, Inc., C.A. No. 1:23-cv-00975 (D. Del.), related to alleged infringement
of the ’327 patent; |
| · | United Therapeutics Corporation v. Liquidia Technologies, Inc., C.A. No. 1:25-cv-00368 (M.D.N.C.), related to alleged infringement
of U.S. Patent No. 11,357,782; |
| · | Liquidia Technologies, Inc. v. United Therapeutics Corporation, C.A. No. 1:25-cv-00299 (M.D.N.C.), related to alleged infringement
of U.S. Patent No. 10,898,494; |
| · | United Therapeutics Corporation and Lung Biotechnology PBC v. Liquidia Technologies, Inc. and Robert Roscigno, No. 21CVS004094-310
(N.C. Super. Ct.), related to alleged misappropriation of trade secrets; |
| · | United Therapeutics Corporation and Lung Biotechnology PBC v. Robert Roscigno and Liquidia Technologies, Inc., No. 24CVS3755
(N.C. Super. Ct.), related to alleged breach of contract; and |
| · | Sandoz Inc. and RareGen, LLC v. United Therapeutics Corporation and Smiths Medical ASD, Inc., No. 2:19-cv-1070 (D.N.J.), and
the related appeals, Nos. 24-3067, 24-3116 and 24-3146 (3d Cir.), related to alleged antitrust violations. |
Financial Terms of Settlement
Under the agreement, Liquidia will make a net payment to UTHR of $175
million within 30 business days. The net payment includes funds paid by UTHR to Liquidia to resolve the antitrust litigation tied to Treprostinil
Injection. Liquidia will also pay $145.4 million in two equal installments of $72.7 million due on or before January 31, 2027, and April
30, 2027, respectively.
In connection with the settlement, Liquidia entered into agreements
with the parties with interests in the antitrust litigation related to Treprostinil Injection. Under those agreements, Liquidia will pay
an aggregate of $60.3 million this month in full satisfaction of those parties’ interests in the antitrust litigation. Concurrently,
Liquidia terminated the promotional agreement tied to Treprostinil Injection and will no longer commercially support the product in the
market.
Michael Kaseta, Chief Operating Officer and Chief Financial Officer,
said: “We are confident this settlement is in the best interests of our patients and shareholders and in our ability to meet the
settlement obligations while continuing to invest in the business. We expect to fund the outlined payments from the ongoing sales of YUTREPIA
and cash on hand. Preliminary and unaudited results from the third quarter 2026 included YUTREPIA net product sales of $222.7 million,
contributing to total cash and cash equivalents of $396.1 million as of September 30, 2026. We expect to rebuild our cash position and
fund our planned clinical studies without requiring additional financing.”
Liquidia will provide a broader update on YUTREPIA’s performance,
its financial position and its pipeline priorities on its third-quarter 2026 earnings call in November.
About YUTREPIA® (treprostinil) Inhalation Powder
YUTREPIA is an 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. YUTREPIA was approved in 2025 for the treatment of pulmonary arterial hypertension (PAH). YUTREPIA
is not approved for the treatment of systemic sclerosis-associated Raynaud’s phenomenon (SSc-RP) or pulmonary hypertension associated
with chronic obstructive pulmonary disease (PH-COPD); it has received Fast Track designation from the FDA for SSc-RP.
About Pulmonary Arterial Hypertension (PAH)
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 Liquidia Corporation
Liquidia Corporation is a biopharmaceutical company driven by science
and compassion to revolutionize care for patients with challenging respiratory and vascular 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 YUTREPIA® (treprostinil) inhalation powder, a drug approved in 2025 for the treatment of
PAH. YUTREPIA is currently under development for other indications, including SSc-RP and PH-COPD. The company is also developing L606,
an investigational extended-release formulation of treprostinil administered twice daily with a next-generation nebulizer. To learn more
about Liquidia, please visit www.liquidia.com.
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 the settlement agreement and its anticipated benefits; the amount, timing and funding
of payments under the settlement agreement and the agreements with Sandoz Inc., Henderson SPV, LLC, and PBM RG Holdings, LLC; the transfer
of commercial rights related to Treprostinil Injection to Sandoz; the filing and entry of dismissals of the pending litigation; the timing
and outcome of FDA review of the Prior Approval Supplement to remove the PH-ILD indication from the YUTREPIA label; the impact of ceasing
PH-ILD promotion and sales on YUTREPIA revenue; continued availability of YUTREPIA for patients with PAH; our future results of operations,
financial position and cash resources; and our development plans for L606 and for YUTREPIA in SSc-RP, PH-COPD or other indications, are
forward-looking statements. These statements involve significant risks and uncertainties, and actual results could differ materially from
those expressed or implied herein. Among other things, the settlement agreement does not extend to indications other than PAH or to new
treprostinil-containing products, and United Therapeutics may assert patents against our development programs or future products. Fast
Track designation does not guarantee that YUTREPIA will receive FDA approval for the treatment of SSc-RP or that development will proceed
on the anticipated timeline. 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, 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.
The estimated preliminary unaudited financial information for the period
ended September 30, 2026 included in this press release may contain forward-looking statements that are based on information available
to the Company as of the date of this press release. The Company’s financial closing and review procedures for the period ended
September 30, 2026 are not yet complete, and actual results may differ from these preliminary estimates as a result of final accounting
adjustments, the completion of internal control processes, and other developments that may arise prior to the finalization of the Company’s
financial statements. The preliminary financial information included in this release have not been reviewed by the Company’s independent
registered public accounting firm and should not be considered a substitute for the Company’s unaudited interim financial statements.
Accordingly, undue reliance should not be placed on this preliminary information.
Contact Information
Investors:
Jason Adair
Chief Business Officer
919.328.4350
Media:
media@liquidia.com
