Liquidia Technologies, Inc.

Board will help advance the mission and support development of our game-changing IUD for contraception (3D-001)MANSFIELD, Mass., March 13, 2024 (GLOBE NEWSWIRE) -- 3Daughters, a clinical development company fueling evolutionary healthcare for women, announced the appointment of Michele LaRussa, Vincent J. Miles, Ph.D., and Sarah J. Stevens, Ph.D., to serve on the Company’s Board of Directors. These strategic appointments mark a significant milestone in the company's plan to revolutionize birth control with a newly designed Intrauterine Device (IUD), 3D-001, to address a major barrier to adoption, insertion pain. An IND for 3D-001 will be filed this year followed by a Phase 1 clinical trial. Ms. LaRussa, Dr. Miles, and Dr. Stevens provide a collective wealth of experience and skillful expertise from the life sciences industry, perfectly aligning with 3Daughters' mission to drive therapeutic innovation within the women's health arena. Their appointments are set to enhance the company's strategic direction and drive the development of groundbreaking healthcare solutions for women, starting with the revolutionary frameless, magnetic nonhormonal IUD. Mary Beth Cicero, CEO of 3Daughters, expressed her enthusiasm about the new additions to the board: "We are incredibly excited to have the collective strengths of Michele, Sarah, and Vin on our Board of Directors. Their invaluable experience with the crucial aspects of an emerging life sciences company - regulatory affairs, drug development, manufacturing, and fundraising, are exactly what 3Daughters needs as we move into the clinic with our novel IUD and Slider™ system (inserter/retriever) to address insertion pain, a major barrier to adoption. Their guidance and enthusiasm will be instrumental in shaping a future where women will have improved healthcare options." Ms. LaRussa has a distinguished career in regulatory affairs and clinical development, built over 32 years of experience in various therapeutic areas. Currently, she is the Chief Regulatory Officer at SFJ Pharmaceuticals, following a significant 13-year tenure at Novartis, where she held leadership roles, including Chief of Staff to the Global Head of R&D. Her extensive background includes key positions at Allergan, GlaxoSmithKline, Kala Pharmaceuticals, and Liquidia Technologies, and she was the Chief Regulatory Officer at Atox Bio. Michele has a B.Sc. in Chemistry degree from the University of South Florida. Dr. Miles is a well-known and respected member of the biotech and venture capital community with a career spanning more than 45 years that encapsulates a spectrum of pivotal roles that have influenced the industry's growth. For the last 16 years, Vin has been a partner and executive director at Abingworth, a key life sciences investment firm, and has served on the boards of multiple biotech companies, including IFM Therapeutics, Dicerna Pharmaceuticals, Chiasma, Hydra Biosciences, and Personalis. His previous roles include Senior Vice President at Alnylam Pharmaceuticals and VP positions at Millennium Pharmaceuticals, RiboGene, and Pharmacia. He also directed the technology transfer office at Dana-Farber Cancer Institute and started his career in R&D at Amersham International. Dr. Miles holds a B.Sc. in Biochemistry and a Ph.D. in Biochemical Embryology from University College London. Dr. Stevens, with over 20 years in the biopharmaceutical industry, currently leads the Labs & Cleanroom on Demand Business Unit at Azzur Group, delivering bespoke solutions to early-phase manufacturers for faster market entry. Her career spans pivotal roles in CDMO and CRO leadership, including Senior Vice President at Quotient Sciences and Global Head of Drug Product Development at Albany Molecular Research. Sarah has a rich background in drug development and manufacturing and contributed to novel drug formulations at Encap Drug Delivery with patented oral dosage forms during her post-doctoral fellowship at the University of Strathclyde. Her academic credentials include an M.Pharm and an MBA from the University of Strathclyde, a Ph.D. in Pharmaceutical Sciences from the University of Manchester, and a Lean Six Sigma Green Belt. Michele, Vin and Sarah’s expertise and experience will significantly contribute to the company's aggressive plans for clinical development of a game-changing IUD for contraception. With this first product, 3Daughters expects to disrupt the IUD market and establish a position as a major innovator in women's healthcare. About 3Daughters™ 3Daughters is a clinical development company focused on evolutionary healthcare for women where cutting-edge research and innovation is desperately needed. The Company’s technology platform is based on physics and geometry to deliver targeted therapy to the uterus. The first product, (3D-001), is a frameless, magnetic, nonhormonal intrauterine device (IUD) for long-acting contraception that conforms to a woman’s body and is combined with our unique, patented Slider™ system (insertion/ retrieval) designed to eliminate steps and pain points as well as the nuisance factor of strings (needed for removal). 3Daughters’ vision is to solve health issues for women, particularly significant (neglected) problems. 3Daughters plans to radically disrupt the IUD market by addressing the major adoption barrier — insertion pain. This pain is associated with all current rigid, plastic T-shape framed IUDs on the market and prevents women from selecting one of the most effective forms of birth control. Visit 3daughtershealth.com for more information. Contact: Louis Scottiinfo@3Daughtershealth.com

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the United States Court of Appeals for the Federal Circuit affirmed the district court decision in the patent litigation United Therapeutics brought against Liquidia Technologies, Inc. The Federal Circuit affirmed that Liquidia’s proposed Yutrepia™ product infringes a United Therapeutics’ patent, U.S. Patent No. 10,716,793 (the ’793 patent). As a result, the U.S. Food and Drug Administration (FDA) cannot grant Liquidia final approval for its Yutrepia product until expiration of the ’793 patent, May 14, 2027, except in certain circumstances discussed below. The Federal Circuit affirmed the district court’s decision that Liquidia would induce infringement of various claims of the ’793 patent by marketing Yutrepia and that Liquidia failed to prove any claim of that patent invalid. The ‘793 patent relates to a method of administering treprostinil via inhalation. The Federal Circuit also affirmed the district court’s decision that certain claims of another United Therapeutics patent, U.S. Patent No. 9,593,066 (the ’066 patent), are either invalid or not infringed by Liquidia. The ’066 patent relates to a method of making treprostinil, the active pharmaceutical ingredient in both Tyvaso® (treprostinil) Inhalation Solution and Tyvaso DPI® (treprostinil) Inhalation Powder. “Today’s decision vindicates our position, as confirmed earlier by the district court, that Yutrepia is an infringing product. We will continue to vigorously defend our intellectual property,” said Shaun Snader, Vice President and Associate General Counsel – IP and Litigation at United Therapeutics. Both parties have the opportunity to request rehearing by the Federal Circuit with respect to the adverse portions of the Federal Circuit’s affirmance. Last year, the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office issued a final written decision in an inter partes review (IPR) of the ’793 patent initiated by Liquidia finding all claims of the patent to be unpatentable. United Therapeutics appealed that decision to the Federal Circuit, and that appeal is pending. United Therapeutics expects that the PTAB decision will not affect the district court’s order barring FDA from granting final approval for Yutrepia unless all claims Liquidia was found to infringe are found invalid following exhaustion of all appeals. United Therapeutics: Enabling Inspiration At United Therapeutics, our vision and mission are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. You can learn more about what it means to be a PBC here: unither.com/PBC. Forward-looking Statements Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements regarding ongoing patent litigation with Liquidia, the potential timing of FDA approval for Yutrepia, and our goals of innovating for the unmet medical needs of our patients and to benefit our other stakeholders and furthering our public benefit purpose of developing novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of July 24, 2023, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events, or any other reason. TYVASO and TYVASO DPI are registered trademarks of United Therapeutics Corporation and/or its subsidiaries. YUTREPIA is a trademark of Liquidia Corporation. View source version on businesswire.com: Contacts Dewey Steadman (202) 919-4097 ir@unither.com Source: United Therapeutics Corporation View this news release online at:

United Therapeutics claimed victory earlier this week in a patent battle against Liquidia Technologies, which won tentative FDA approval for its treprostinil inhalation powder, Yutrepia, to treat pulmonary arterial hypertension (PAH) and would compete directly with United’s soon-to-be blockbuster Tyvaso DPI. The Delaware-based district court found that Liquidia failed to prove by “clear and convincing evidence” that certain claims on one of the patents are invalid. But both companies claimed victory over other parts of the decision, and when Yutrepia will launch is still up in the air. While United says it expects the court to enter an injunction barring the FDA from granting final approval for Yutrepia until expiration of one of the patents, known as the ’793 patent, on May 14, 2027, Liquidia CEO Roger Jeffs said he’s optimistic of a full approval in mid-2024. “We are pleased that all three patents asserted against us have been found to be either invalid or not infringed among the different legal proceedings,” Jeffs said in a statement. “While we are disappointed with the Court’s decision on the ‘793 patent, we are optimistic that the PTAB’s favorable decision will be affirmed on appeal, thereby unlocking the path to potential approval of YUTREPIA by mid-2024, if not earlier.” The FDA only just approved Tyvaso DPI last May for PAH, and the first commercial shipments to specialty pharmacies occurred in June, the company said. But Tyvaso also won approval for its pulmonary hypertension associated with interstitial lung disease (PH-ILD) indication on March 31, 2021, and in April, CMS updated its local coverage determination for Tyvaso to include an indication for PH-ILD, which became effective in June. United Therapeutics has high hopes for Tyvaso, which has seen steady growth from $480 million in sales in 2020 to more than $607 million in 2021. Cowen analyst Joseph Thome models peak revenues of $1.6 billion in 2025 for United’s inhaled franchise.