Lung Biotechnology PBC

→ Another CEO opportunity has presented itself for James Scibetta , the chief executive of Maverick Therapeutics when Takeda ponied up $525 million in March to buy its T cell collaborator and integrate the staff into the R&D unit. Scibetta has signed on as CEO of antibody startup ImmuneID , co-founded and chaired by Longwood Fund ’s Christoph Westphal with tech coming from Stephen Elledge ’s lab at Harvard. So ends a fleeting CEO tenure for David Donabedian , who will stay close by as an advisor. Scibetta, the CFO and later president of Pacira Pharmaceuticals until he joined Maverick in 2017, steps forward to lead a biotech that’s chalked up $70 million in financing, including $50 million in a Series A this summer. → Roger, over and out: Roger Sidhu has bolted from Roivant — where he was CMO and head of R&D — to take the CMO job at IL-2 biotech Brooklyn ImmunoTherapeutics , which is in a Phase IIb trial of its cytokine-based cell therapy IRX-2 for head and neck cancer. Sidhu, an Amgen vet, had been VP of clinical development at Kite before flying over to Roivant, the Vivek Ramaswamy brainchild that coasted down the SPAC highway to Nasdaq with Jim Momtazee ’s Montes Archimedes Acquisition Corp this spring. → Michael Amoroso has cycled through an entire career in a year’s time at Abeona . First, he was named chief commercial officer in July 2020; then he was promoted to COO that October; then he climbed up to CEO in March; and now he’s chairman of the company as Vishwas Seshadri takes over as president and CEO. The rise to the top spot is also a lightning-quick one for Seshadri, who just became Abeona’s head of research and clinical development in June and was a team lead for the Breyanzi launch with Bristol Myers Squibb . The two changes take effect Oct. 15 as Steven Rouhandeh retires from his role as chairman. That’s not all at Abeona: Brendan O’Malley and Brian Kevany have also received promotions to SVP, general counsel and VP, chief technical officer, respectively. Head of business operations Scott Nogi will branch out further and become site head at the cell and gene therapy biotech’s facility in Cleveland. Wait, we’re not done yet: Carl Denny joins the retooled team as VP, regulatory affairs and so does Kate Imhoff as senior director, regulatory affairs. Both come from Sarepta — Denny was executive director, regulatory strategy and Imhoff was director, regulatory strategy. → Sage hopes the tide has turned after zuranolone bombed in Phase III of the MOUNTAIN study in December 2019, with the major depressive disorder (MDD) drug hitting its primary endpoint in a second Phase III this summer. CEO Barry Greene has added to his crew at Sage, poaching new chief commercial officer Chris Benecchi from Alexion , where he was global head of commercial excellence. Benecchi’s eight years at UCB came to a close in 2019 as global launch head, commercial and medical affairs, immunology, and before that he logged another eight years in sales leadership and marketing posts at Takeda. → The band is truly back together with Martin Babler as he becomes CEO of Foresite -backed Esker Therapeutics , taking a cast of thousands with him from Principia , the previous biotech he helmed that was sold to Paul Hudson and Sanofi for $3.7 billion in August 2020. The stampede of staffers from Principia is comprised of CSO and head of CMC David Goldstein ; CBO and general counsel Roy Hardiman ; head of research Kenneth Brameld ; SVP of immunology and biology Claire Langrish ; SVP of pharmacology and project team leader Phil Nunn ; and human resources business partner Tori Lowell . The only new appointee in this group who has no previous association with Principia is VP of toxicology Mike Taylor , the founder and ex-principal of NonClinical Safety Assessment . → With an unclear future at the helm of FerGene after its recent implosion , CEO David Meek has made a rebound and stepped into the head honcho role at Mirati Therapeutics , taking over for founding CEO Charles Baum . Prior to his stint at FerGene, Meek was CEO at Ipsen and previously was an executive VP and president of oncology at Baxalta , which was acquired by Shire in 2016. Meek also held roles at Endocyte , Novartis and J&J over the course of his 30-year career. → Computational chemistry and drug discovery trailblazer Nimbus has another $105 million at its disposal and has tapped Ian Sanderson as CFO. Since 2016, Sanderson served in the same capacity at Boston Pharmaceuticals and was also CFO at Catabasis Pharmaceuticals , which operates under the new name Astria Therapeutics . Nimbus will use the latest round of cash on pushing its tyrosine kinase 2 (TYK2) inhibitor into Phase II trials. → Big changes are underway at Aerie Pharmaceuticals : After eight years at the helm, Vicente Anido will no longer serve as chairman and CEO. Benjamin McGraw will take over as interim executive chairman of the board while the company searches for a new CEO. Aerie also announced that Erik Pacyniak will be director of toxicology and drug disposition. Aerie hopes to rebound from its failed dry eye disease trial earlier this month, especially after it defiantly claimed that the primary endpoints of the trial were “not required.” → Jessica Ballinger has been promoted to president and COO of Lyndra Therapeutics , co-founded by Bob Langer and riding high with a Series C injection surpassing $60 million as the Watertown, MA biotech strives to make daily pills obsolete. Before joining Lyndra in 2016 as VP of reimbursement and strategic alliances, Ballinger spent 10 years at Pfizer in numerous posts and another four with Biogen . Running alongside Ballinger’s promotion, ex- AIG chief investment officer Doug Dachille and AIG managing partner Jillian Moo-Young are now on Lyndra’s board of directors. → Oxford biotech MiroBio , developing antibodies for autoimmune diseases, has named Novartis vet Carolin Barth CEO. When she embarked upon her Novartis journey 17 years ago, Barth was a global brand leader for Lucentis ; when she left for MiroBio, she was global head of commercial and pipeline strategy, cell and gene. MiroBio launched almost exactly two years ago with executive chairman and SR One venture partner Eliot Charles handling CEO duties on an interim basis. → Belgium-based biotech Rewind Therapeutics is bringing on Anja Harmeier as CEO. Most recently, Harmeier served as partner at Pureos Bioventures . Prior to that, she held several positions at Roche , working her way up to franchise and senior project leader in the rare diseases division. Harmeier has also served on the board of directors at Vivet Therapeutics , Entrada and NMD Pharma . → Kathy Yi is out at Cerevel after two years as CFO “to pursue other personal and professional interests,” and in the meantime VP, finance and chief accounting officer Mark Bodenrader will take over as interim CFO. The Tony Coles -led Pfizer spinout announced an underwritten public offering in July totaling $350 million following the release of positive schizophrenia data just days earlier. Although this change goes into effect immediately, Yi will help with the transition until Nov. 15. → Shy and reserved Alex Zhavoronkov is not, pulling in a hefty $255 million round a few months ago and asserting that Insilico is in position to be the Amazon and Google of AI drug discovery. This week, Insilico has brought on Nirav Jhaveri as CFO. Jhaveri recently took care of CFO responsibilities at Fortress Biotech sub Journey Medical Corporation , and from 2014-20 he was Fortress’ VP of business development. → Frank Neumann pulled a fast one when he left Verastem Oncology two weeks into the job as CMO to lead clinical development at Kite in February. Verastem now hopes Pfizer alum Louis Denis can stay a little longer as its medical chief. After nine years in oncology clinical development and medical affairs at Pfizer, Denis then set off for Boehringer Ingelheim in 2010, taking charge of clinical development for afatinib , a lung cancer drug at the center of a collaboration with CureVac that will dissolve in November . Since 2015, Denis had been CMO with Asana BioSciences . → In a press release that rivals Michael Jordan’s 1995 declaration of “I’m Back” for its brevity, Helix BioPharma announced that chairman Sławomir Majewski will become interim CEO. The former chief executive of the Canadian immuno-oncology biotech Heman Chao, Majewski has chaired the scientific advisory board since he stepped down Sept. 1. The one-sentence release does indicate the search for a permanent CEO is ongoing. → If it seems like just the other day that Brendan Delaney changed jobs, then you’re an observant Peer Review reader. Delaney — an oncology marketing vet with Bristol Myers, Genentech and Novartis — took on the chief commercial officer job at Constellation Pharmaceuticals in January, but he’s on the move again, becoming COO at Los Angeles-based Aadi Bioscience . He reunites with chairman Behzad Aghazadeh , who was CEO at Immunomedics when Delaney was his CCO before the Gilead acquisition . In May, Aadi Bioscience reverse merged with Aerpio Therapeutics , raising $155 million in the process. → South San Francisco-based GenEdit is ready for prime time with a $26 million round to solve the “delivery problem” in gene therapy, appointing Romuald Corbau as CSO and Aaron Mishel as CFO. Corbau, a Spark vet who spoke to our Nicole DeFeudis for Thursday’s story on the Series A financing, was recently in Peer Review when he left Freeline in late June after getting promoted to CSO in September 2020, clearing the path for co-founder Amit Nathwani as his interim replacement. Mishel comes to GenEdit from the same position at Magnetic Insight and is the ex-director of business & corporate development at BioMarin . → Early this week immune modulation company Ventyx Biosciences topped off its initial $114 million raise with a $51 million Series B , and Sheila Gujrathi leads the list of leadership moves here as the new chair of Ventyx’s board. Gujrathi was CEO of Gossamer Bio until trial failures prompted her to cede her position to old Receptos colleague Faheem Hasnain . Akero Therapeutics CFO William White nabs a seat on the board, while ex-Gossamer CSO and current Pioneering Medicines CSO Luisa Salter-Cid will also be on Ventyx’s scientific advisory board. In the C-suite, Ventyx is bringing on Jörn Drappa as CMO. An alum of Amgen, Genentech and MedImmune , Drappa was most recently EVP of R&D at Horizon Therapeutics , and until the $3 billion buyout , he led R&D and was CMO of Viela Bio . → Speaking of Viela Bio, CFO Mitchell Chan made his own exit, taking the same position on Joanne Smith-Farrell ’s team at Be Bio . Chan, who will also be head of corporate strategy, has plenty of Big Pharma experience as AstraZeneca ’s director of investor relations along with gigs at Roche and Genentech. His appointment fills the C-suite further after Be Bio greeted president and COO Krishnan Viswanadhan and chief people officer Brad Hartman last month. → Meanwhile at Gossamer, Bryan Giraudo has tacked on the COO title along with the CFO post he’s held since May 2018. Before he jumped to biotech, Giraudo was senior managing director at SVB Leerink for nine years. → Doug Fambrough has added to his lineup of execs at RNAi-focused Dicerna while shifting Rob Ciappenelli to chief strategy officer and promoting Marc Abrams . The CCO at Dicerna since 2019, Ciappenelli was previously head of commercial at Momenta and head of commercial effectiveness with Shire. Abrams, elevated to SVP of discovery research, originally hopped on board at Dicerna in 2014 as senior director, preclinical development after 16 years at Merck . Finally, Kristen Sheppard has been named SVP of investor relations and corporate communications. She had fulfilled the same responsibilities at Akebia Therapeutics . → Avinash Desai has been promoted to CMO at radiotherapy player Actinium while two other execs dive in as well. Desai, initially named EVP, clinical development, operations and medical affairs in late 2020, had been involved in medical affairs with a batch of big names: Janssen , Eisai , Takeda, Eli Lilly , and before he joined Actinium, GlaxoSmithKline . Also, Actinium has tapped Arun Swaminathan as chief business and commercial officer and Paul Diamond as VP, patent and legal counsel. Swaminathan was in commercial and business development at Bristol Myers for 12 years, with a stop at Covance in between, and comes to the New York biotech after his tenure as CBO at Alteogen . ( Mark Kubik left his CBO post at Actinium to take the same position at Genor BioPharma .) At Enzo Biochem , Diamond was senior counsel, patents and business development before moving on to Actinium. → Now helmed by former Codiak exec Benny Sorensen , Copenhagen bleeding disorder biotech Hemab has $55 million in Series A funding to work with — thanks to headliners Novo Seeds and RA Capital — and has recruited Mads Behrndt as CFO. Behrndt has held a number of posts at PwC the last 14 years, and since 2017 has been a partner for the corporate finance team. → Maria Fuentes has been named CSO at San Francisco exosome outfit Mantra Bio , which shed its stealth-mode skin with a $25 million Series A last July. Fuentes, a Big Pharma alum with Roche (research director and head of the respiratory drug discovery group) and Bristol Myers (group director, fibrosis discovery biology), has recently been EVP of research at Blade Therapeutics . → In its first big Peer Review development since Jude Samulski was named gene therapy special advisor, Selecta Biosciences has picked up Kevin Tan as CFO. Before this opportunity at Carsten Brunn -led Selecta, Tan was on Doug Ingram ’s team at Sarepta as treasurer, and earlier he held the role of senior portfolio manager at CPP Investments . → German CDMO Rentschler Biopharma , which will have a presence at the Cell and Gene Therapy Catapult in the UK by next year , has appointed Christian Schetter as CSO. Schetter was managing director at Arix Bioscience and has also helmed Rigontec , the retinoic acid-inducible gene I (RIG-I) biotech that Roger Perlmutter purchased at Merck in 2017 for $150 million upfront and $603 million overall. → Lauren Gordon will lead all things HR as first chief people officer of Boston AI life sciences company ConcertAI . Gordon comes to ConcertAI after also being a chief people officer at Tmunity , the CAR-T biotech co-founded by Carl June which had to scrap its lead program after two patients died due to neurotoxicity in June. → Endeavor BioMedicines has plucked up Srikanth Pendyala as its first CMO. Pendyala joins the company from BridgeBio , where he served as VP of clinical development. Prior to that role, Pendyala held roles at Genentech/Roche, Merck and Theravance . → Gene therapy-focused Renovacor , which picked up Marc Semigran as CMO back in June among many others, has named Jordan Shin as SVP of clinical development and translational science. Shin comes to the Philadelphia-based company from Lung Biotechnology , where he served as VP of medical development. Prior to that, Shin was with Acceleron and Reify . → Hopping over to Denmark, Evaxion Biotech raised $30 million in a modest IPO early this year for its AI platform to develop immuno-oncology drugs, and Evaxion has promoted Birgitte Rønø to CSO, making the move up from senior director of I/O. Prior to her arrival at Evaxion in 2017, Rønø had a four-year run that started in immunopharmacology at Novo Nordisk , and in her final position there, she was a specialist in diabetes prevention research. → Dutch biotech Xenikos has named Hassan Aly as its new CMO. He joins the company close to two months after former CFO and CBO Stan Musial joined Aruvant as their CFO. Xenikos also secured just under $47 million over two weeks ago in convertible debt to fund a registrational Phase III trial in the US and the EU. → Dotmatics , a cloud-based scientific R&D data management platform that was snapped up by Insightful Science in March, has passed down the title of president to Mike McKee , who will succeed founder Stephen Gallagher . McKee was most recently EVP and general manager of insider threat at Proofpoint . McKee has also held positions at ObserveIT and Rapid7 among others. → Adaptive Phage Therapeutics has enlisted Michele Wales as chief legal officer. Wales hails from InHouse Patent Counsel , where she served as principal and founder. Prior to that, Wales had a 14-year stint at Human Genome Sciences . → “Wnt” some HR expertise? Wnt pathway-focused Surrozen , taking part in the SPAC mania through a $212 million reverse merger with Consonance Capital Management this spring, has selected Liz Nguyen as VP and head of human resources. Nguyen had been MyoKardia ’s executive director, head of HR business partnering & interim HR site head after Bristol Myers’ decision to purchase the company and she spent six years with MyoKardia overall. → Once known as diagnostic company Novellus , precision oncology outfit Fore Biotherapeutics keeps it in the short grass with Kim Blackwell teeing it up as R&D/science chair along with Sujit Basu as SVP of global manufacturing and technical operations. Formerly VP of early phase oncology and immuno-oncology at Eli Lilly, Blackwell spent the last year as CMO and SVP, clinical oncology development at Tempus Labs . As for Basu, he comes from Takeda by way of Shire and was most recently the pharma giant’s VP, pharmaceutical sciences, R&D. → Merck gave away lonafarnib to Palo Alto, CA-based Eiger BioPharmaceuticals in 2018, and by last November the FDA OK’d the drug for the ultra-rare condition progeria (Hutchinson-Gilford progeria syndrome). Eiger now brings in ex-BioMarin senior counsel Erik Atkisson as general counsel and chief compliance officer. Since 2019, Atkisson had taken on the roles of chief compliance officer, legal counsel, and privacy officer at Cytokinetics . → Lisa Caperelli will take on the newly created VP of investor relations position at Arbutus . Before joining the management team at Arbutus — which specializes in developing a cure for people with HBV infection — Caperelli was associate VP of investor relations at Harmony Biosciences . She has also held positions in investor relations at Marinus , Advaxis , PolyMedix and Windtree Therapeutics . → DNA player Touchlight — which doubled its fundraising round this year for a total of $125 million — has added some new faces to its leadership team with the appointments of Robin Bodicoat (head of marketing), Rhona McIntyre (head of sales for Europe), and Julie Foster (head of sales for North America). Bodicoat previously held roles at Quotient Sciences and Source BioScience . Meanwhile, Foster brings with her experience from her time at Lonza and Epistem , while McIntyre hails from Lonza Biologics and Parexel . → Scottish gamma delta T cell biotech TC Biopharm appointed Sebastian Wanless as its new senior clinical director. Wanless joins TC BioPharm after leaving Bristol Myers, where he spent 18 years and closed out his time there as VP of intercontinental research. → Amphista announced that Joshua Brumm will replace Satish Jindal as its new independent chairman. Brumm currently serves as president and CEO of Dyne Therapeutics , and before joining Dyne, he was COO and CFO of Kaleido Biosciences . Amphista, a UK-based protein degradation biotech, debuted last April and hauled in a $53 million Series B round in March. → Aarvik Therapeutics has brought on Richard Scheller, former CSO and head of therapeutics of 23andMe, as its board member and scientific advisory board chair. Previously, Scheller was SVP of research and EVP of research and early development at Genentech. Scheller currently sits on the boards of BridgeBio, 23andMe, Alector , DiCE Therapeutics and Maze Therapeutics . In addition to Scheller’s appointment, Aarvik has tapped Melissa Starovasnik to be a part of its scientific advisory board. Starovasnik spent nearly three decades at Genentech, serving in a variety of roles such as VP, protein sciences and VP, research operations and structural biology. Starovasnik also sits on the board of Twist Bioscience . → At the same time that the FDA granted humanitarian use device designation to its treatment of Dandy Walker syndrome, Bionaut Labs has plucked up former president and founding CEO Kite CEO Aya Jakobovits to be a part of their advisory board. Until March 2018, Jakobovits served as president and CEO of Adicet Bio and previously held roles at Agensys and Abgenix . → Intranasal vaccines-focused BlueWillow Biologics has brought on three new hires to lead its scientific advisory board: Robin Isaacs (former CMO of Entasis Therapeutics ); Akiko Iwasaki (Yale professor in the department of immunobiology and department of molecular cellular developmental biology); Steve Projan (former SVP of R&D in the infectious diseases & vaccines innovative medicines unit at MedImmune ). → Stanford spinout Jasper Therapeutics , which grabbed its ticket to Nasdaq via SPAC reverse merger in May, has appointed Lawrence Klein and Chris Nolet to its board of directors. Klein is the current COO of CRISPR Therapeutics , while Nolet was the former West region life sciences industry leader and partner at Ernst & Young . → Jae Park is the newest addition to Allogene ’s scientific advisory board that is chaired by Ton Schumacher . Park is a hematologist-oncologist on the Leukemia Service at Memorial Sloan Kettering Cancer Center. → Coinciding with the departures of Frazier managing partner Patrick Heron and Rob Hopfner of Pivotal bioVenture Partners , Annie Drapeau and Teri Loxam have joined the board of directors at Vaxcyte . Drapeau is chief people officer at Toast , a payment software company geared toward restaurants, and Loxam is CFO at SQZ Biotechnologies . → IsoPlexis , the Connecticut biotech zeroing in on personalized protein “barcodes” that filed for a $100 million IPO in July, has a seat reserved for Jason Myers on the board of directors. Myers is CEO of Genapsys and the ex-CEO of ArcherDX , bought by Invitae for $1.4 billion in 2020. → North Carolina biotech BioCryst has brought FDA veteran and Parexel VP Amy McKee into its board of directors. She joined Parexel as VP of regulatory consulting services in 2019 after an 11-year career at the FDA, ending up as the deputy director for the Oncology Center of Excellence. → Optibrium , a developer of software for drug discovery, has named Andy Black as non-executive chair of its board of directors. Black is the co-founder and former CEO of Kinapse and currently serves as chair of Sygnature Discovery . → ReForm Biologics has recruited Roopom Banerjee (former president and CEO of Raindance Technologies ), Kirsten Flowers (CCO for Kura Oncology and former SVP of commercial operations at Array ), Stuart Randle (former division president of Baxter Healthcare ) and Edward Sullivan (comprehensive business strategist and financial expert) to be part of its board of directors. Paul Schloesser also contributed to this edition.

Sept. 22, 2021 20:05 UTC Dr. Shin to help advance REN-001 into the clinic by leveraging nearly two decades of expertise in clinical development, academic research and medical practice PHILADELPHIA--(BUSINESS WIRE)-- Renovacor, Inc. (NYSE: RCOR), an early-stage biotechnology company developing adeno-associated virus (AAV)-based gene therapies for devastating cardiovascular and central nervous system diseases resulting from BAG3 gene variants, today announced the appointment of Jordan Shin, M.D., Ph.D., as Senior Vice President of Clinical Development and Translational Science. “We are excited to welcome Jordan to Renovacor’s leadership team during this pivotal time for the company,” said Magdalene Cook, M.D., Chief Executive Officer of Renovacor. “Our lead program, REN-001, continues to advance towards an anticipated IND-filing in mid-2022 and earlier this month we entered the public market following the closing of our merger and concurrent financing. We believe Jordan’s nearly two decades of experience leading therapeutic candidates through the clinical trial process will be tremendously valuable as we drive forward our mission of developing novel gene therapies for diseases where there is a significant unmet medical need.” Dr. Shin added, “It’s an honor to join Renovacor’s team of highly motivated and experienced industry experts. The company’s preclinical data set highlights REN-001 as a promising step forward towards addressing the genetic cause of BAG3-associated familial dilated cardiomyopathy, a devastating disease with no approved treatments that target the underlying cause. Renovacor’s development strategy utilizing a validated AAV9 capsid and one-time payload is based on strong foundational science, and I believe the focus on local delivery of REN-001 provides key advantages and differentiation from other genetic therapies currently in development.” Prior to joining Renovacor, Dr. Shin served as Vice President of Medical Development at Lung Biotechnology, PBC, a subsidiary of United Therapeutics, Inc. While at Lung Biotechnology, Dr. Shin led all clinical aspects of study design and oversight, medical monitoring, site selection, and interaction and engagement for the company’s small molecule programs and oversaw FDA and international regulatory submissions for devices, small molecules and cell and gene therapies. Prior to Lung Biotechnology, he served as a consultant for Acceleron Pharma, Inc., a biopharmaceutical company developing TGF-β-targeted therapies for pulmonary and hematological diseases, and Reify Corporation, which develops advanced phenotypic drug discovery screening technologies for the biotechnology and pharmaceutical industries. Dr. Shin previously served as a board observer for Celularity, Inc., a clinical-stage biotechnology company advancing off-the-shelf, allogeneic cell therapies for cancers and degenerative diseases. Prior to his career in industry, Dr. Shin served as a physician at Massachusetts General Hospital and an assistant professor of medicine at Harvard Medical School and specialized in the treatment of patients with advanced heart failure and heart transplant. He earned his M.D. and Ph.D. in biochemistry from the University of Alabama School of Medicine and his bachelor’s degree in applied mathematics from Harvard College. About Renovacor Renovacor is a preclinical stage gene therapy company developing a pipeline of innovative and proprietary AAV-based gene therapies for BAG3 gene mutation-associated diseases in areas of high unmet medical need. Renovacor’s therapeutic focus is initially on cardiovascular disease, with a lead program in BAG3 mutation-associated dilated cardiomyopathy (DCM). For more information, please visit . No part of Renovacor’s website is incorporated by reference into or otherwise deemed to be a part of this press release. Forward-Looking Statements This press release contains certain forward-looking statements within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the anticipated development of Renovacor’s product candidates. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release. You should carefully consider the risks and uncertainties described in the “Risk Factors” section of Renovacor’s definitive proxy statement/information statement dated August 4, 2021 and other documents filed by Renovacor from time to time with the Securities Exchange Commission. These filings identify and address important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Renovacor assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Renovacor gives no assurance that it will achieve its expectations.

Tyvaso® (treprostinil) Inhalation Solution net revenue growth of 29% year over year; total net revenue growth of 23% year over year Tyvaso DPI™ NDA under review with FDA action expected in October 2021 SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Aug. 4, 2021 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) today announced its financial results for the quarter ended June 30, 2021. Total revenue in the second quarter of 2021 grew 23% year over year to $446.5 million, compared to $362.0 million in the second quarter of 2020. "We are pleased to continue our expansion into new indications outside of WHO Group 1 PAH with strong Tyvaso financial results, and with patient enrollment continuing in our PERFECT and TETON phase 3 studies in COPD-associated pulmonary hypertension and in IPF, respectively," said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. "Meanwhile, we are also focused on expanding our medical armamentarium for PAH with the continued progress of our phase 3 studies of once-daily ralinepag, and with our next-generation treprostinil molecules and delivery systems." "As we build traction with the Tyvaso PH-ILD launch, I am also tremendously excited about the uptake of all of our products during the past quarter," said Michael Benkowitz, President and Chief Operating Officer of United Therapeutics. "Indeed, we are currently seeing some of the highest levels of referrals of Tyvaso and Orenitram since their launches and we're well on our way to our goal of doubling the number of Tyvaso patients on therapy by the end of 2022." SECOND QUARTER 2021 FINANCIAL RESULTS Key financial highlights include (dollars in millions, except per share data): Revenues The table below summarizes the components of total revenues (dollars in millions): Net product sales from our treprostinil-based products (Remodulin, Tyvaso, and Orenitram) grew by $56.2 million in the second quarter of 2021 compared to the second quarter of 2020. The increase in Remodulin revenues was driven by a $19.0 million increase in sales outside the United States. While generic competition continues to increase pressure on our international Remodulin revenues, this increase primarily reflects the irregular ordering patterns we typically experience with our international distributors. The growth in Tyvaso revenues resulted primarily from an increase in quantities sold, reflecting an increased number of patients following the pulmonary hypertension associated with interstitial lung disease (PH-ILD) label expansion. The growth in Unituxin revenues resulted primarily from an increase in quantities sold. Expenses Cost of product sales. The table below summarizes cost of product sales by major category (dollars in millions): Cost of product sales, excluding share-based compensation. Cost of product sales for the three months ended June 30, 2021 increased as compared to the same period in 2020, primarily due to an increase in product costs due to an overall increase in sales. Research and development expense. The table below summarizes research and development expense by major category (dollars in millions): Research and development expense, excluding share-based compensation. Research and development expense for the three months ended June 30, 2021 decreased as compared to the same period in 2020, primarily due to: (1) a decrease in milestone payments for the Tyvaso DPI program; (2) a decrease in spending due to the completion of the phase 3 DISTINCT study of Unituxin in 2020; and (3) a decrease in spending following our decision to discontinue development of biomechanical lungs in March 2021. Selling, general, and administrative expense. The table below summarizes selling, general, and administrative expense by major category (dollars in millions): General and administrative, excluding share-based compensation. The increase in general and administrative expense for the three months ended June 30, 2021, as compared to the same period in 2020, was primarily due to: (1) an increase in legal expenses related to litigation matters; (2) an increase in expenses related to disposals of property, plant, and equipment; and (3) an increase in consulting expenses. Share-based compensation. The table below summarizes share-based compensation expense by major category (dollars in millions): The decrease in share-based compensation expense for the three months ended June 30, 2021, as compared to the same period in 2020, was primarily due to: (1) a decrease in STAP expense driven by a seven percent increase in our stock price for the three months ended June 30, 2021, as compared to a 28 percent increase in our stock price for the same period in 2020; and (2) a decrease in stock option expense due to fewer awards granted and outstanding in 2021. Other expense, net. The change in other expense, net for the three months ended June 30, 2021, as compared to the same period in 2020, was primarily due to net unrealized and realized gains and losses on equity securities. Income tax expense. Income tax expense for the three months ended June 30, 2021 and 2020, was $43.9 million and $26.8 million, respectively. The effective income tax rate was 20 percent for the three months ended June 30, 2021 and 2020. Non-GAAP Earnings Non-GAAP earnings is defined as net income, adjusted for: (1) share-based compensation expense (including expenses relating to stock options, restricted stock units, share tracking awards, and our employee stock purchase plan); (2) impairment charges; (3) net changes in recurring fair value measurements; (4) license-related fees; (5) unrealized gains on investments in privately-held companies; (6) purchase of a priority review voucher; and (7) tax impact on non-GAAP earnings adjustments. A reconciliation of net income to non-GAAP earnings is presented below (in millions, except per share data): PRODUCT COMMERCIALIZATION UPDATE Thus far in 2021, we launched one new product and one new product indication. In February 2021, we launched commercial sales of the Remunity Pump for Remodulin, and in April 2021, we launched a label expansion for Tyvaso to include an indication for PH-ILD following approval by the U.S. Food and Drug Administration (FDA) on March 31, 2021. We expect FDA action on our Tyvaso DPI new drug application (NDA) in October 2021. Remunity Pump for Remodulin. In February 2021, we launched sales of the Remunity Pump for Remodulin. The Remunity Pump is a pre-filled, semi-disposable system for subcutaneous delivery of treprostinil. The system consists of a small, lightweight, durable pump and controller designed to have a service life of at least three years. The pump uses disposable cartridges filled with Remodulin, which can be connected to the pump with less patient manipulation than is typically involved in filling other currently-available subcutaneous pumps. Tyvaso Inhalation Solution in PH-ILD. In February 2020, the INCREASE study of Tyvaso in patients with PH-ILD met its primary endpoint of demonstrating improvement in six-minute walk distance (6MWD). Tyvaso also showed benefits across several key subgroups, including etiology of PH-ILD, disease severity, age, gender, baseline hemodynamics, and dose. Significant improvements were also observed in each of the study's secondary endpoints, including reduction in the cardiac biomarker NT-proBNP, time to first clinical worsening event, change in peak 6MWD at week 12, and change in trough 6MWD at week 15. Treatment with Tyvaso of up to 12 breaths per session, four times daily, in the INCREASE study was well tolerated and the safety pro consistent with previous Tyvaso studies and known prostacyclin-related adverse events. Comprehensive data from the INCREASE study were published in the New England Journal of Medicine. The FDA approved Tyvaso for the PH-ILD indication on March 31, 2021, and we launched commercial efforts for the new indication shortly thereafter. Tyvaso DPI. In April 2021, we submitted an NDA for Tyvaso DPI for pulmonary arterial hypertension (PAH) and PH-ILD indications. The FDA accepted our NDA for review, and we expect the agency's review to be complete in October 2021. This represents an expedited review timeframe as a result of our use of the priority review voucher we purchased for $105.0 million in January 2021. The FDA has indicated that approval of the NDA would be subject to an inspection of the Tyvaso DPI manufacturing facility in Danbury, Connecticut, operated by our partner MannKind Corporation, which has been commenced by the FDA and is ongoing. Our Tyvaso DPI NDA includes the results of two clinical studies we conducted of Tyvaso DPI. One was a study in healthy volunteers, comparing the pharmacokinetics of Tyvaso DPI to Tyvaso Inhalation Solution. The study was completed in October 2020, and demonstrated comparable systemic treprostinil exposure between Tyvaso DPI and Tyvaso Inhalation Solution. In December 2020, we completed a clinical study (called BREEZE), which evaluated the safety and pharmacokinetics of switching PAH patients from Tyvaso Inhalation Solution to Tyvaso DPI. The BREEZE study demonstrated the safety and tolerability of Tyvaso DPI in subjects with PAH transitioning from Tyvaso Inhalation Solution, and comparable systemic treprostinil exposure between Tyvaso DPI and Tyvaso Inhalation Solution. Implantable System for Remodulin. In June 2021, we and Medtronic, Inc. (Medtronic) agreed to discontinue further efforts to develop and commercialize the Implantable System for Remodulin (ISR). We are working with Medtronic on a mutually-agreed approach to wind-down the development program, and to support patients already enrolled in clinical studies of the ISR, at United Therapeutics' sole expense. RESEARCH AND DEVELOPMENT UPDATE Updates on select later-stage programs are below. Tyvaso in chronic fibrosing interstitial lung diseases — TETON. We have launched a new phase 3 program called TETON, which will be comprised of one or more phase 3 studies of Tyvaso in subjects with various forms of chronic fibrosing interstitial lung diseases, including patients with idiopathic interstitial pneumonias (IIP), chronic hypersensitivity pneumonitis (CHP), and environmental/occupational lung disease. The first TETON study is enrolling subjects with idiopathic pulmonary fibrosis. The primary endpoint of this study is the change in absolute forced vital capacity (FVC) from baseline to week 52. The TETON program was prompted by data from the INCREASE study, which demonstrated improvements in certain key parameters of lung function in pulmonary hypertension patients with fibrotic lung disease. Specifically, in the INCREASE study, treatment with Tyvaso resulted in significant improvements in percent predicted FVC at weeks 8 and 16, with subjects having underlying etiologies of IIP showing greater improvement. Consistent positive effects were also observed in patients with CHP and environmental/occupational lung disease. These data points, combined with substantial preclinical evidence of antifibrotic activity of treprostinil, suggest that Tyvaso may offer a treatment option for patients with fibrotic lung disease. Tyvaso in PH-COPD — PERFECT. Enrollment is ongoing for the phase 3 PERFECT study evaluating Tyvaso in patients with WHO Group 3 pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD). In a 30-week crossover study, 136 subjects will be randomized between inhaled treprostinil and placebo for a 26-week treatment period. The primary endpoint of the study is the change in 6MWD from baseline to week 12. Ralinepag phase 3 clinical studies — ADVANCE CAPACITY and ADVANCE OUTCOMES. We are enrolling two phase 3 clinical studies to support the potential approval of oral ralinepag for PAH. INDUCEMENT RESTRICTED STOCK UNITS On July 30, 2021, we granted a total of 141 restricted stock units under our 2019 Inducement Stock Incentive Plan to one newly hired employee. These restricted stock units vest in three equal installments on July 31, 2022, 2023, and 2024, assuming continued employment on such dates, and are subject to the standard terms and conditions we filed with the SEC as Exhibit 10.2 to our Current Report on Form 8-K on March 1, 2019. We are providing this information in accordance with Nasdaq Listing Rule 5635(c)(4). WEBCAST We will host a webcast to discuss our second quarter 2021 financial results on Wednesday, August 4, 2021, at 9:00 a.m. Eastern Time. The webcast can be accessed live via our website at . A replay of the webcast will also be available at the same location on our website. UNITED THERAPEUTICS: ENABLING INSPIRATION United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our obsession with quality and innovation, the power of our brands, our entrepreneurial culture, and our bioinformatics leadership. We also believe that our determination to be responsible citizens — having a positive impact on patients, the environment, and society — will sustain our success in the long term. Through our wholly-owned subsidiary, Lung Biotechnology PBC, we are focused on addressing the acute national shortage of transplantable lungs and other organs with a variety of technologies that either delay the need for such organs or expand the supply. Lung Biotechnology is the first public benefit corporation subsidiary of a public biotechnology or pharmaceutical company. Please visit unither.com to learn more. NON-GAAP FINANCIAL INFORMATION This press release contains a financial measure, non-GAAP earnings, which does not comply with United States generally accepted accounting principles (GAAP). This measure supplements our financial results prepared in accordance with GAAP as reported below. We use non-GAAP earnings to assist us in: (1) planning, including the preparation of our annual operating budget; (2) allocating resources in an effort to enhance the financial performance of our business; (3) evaluating the effectiveness of our operational strategies; and (4) assessing our capacity to fund capital expenditures and expand our business. We believe this non-GAAP financial measure improves investors' understanding of our financial results by providing greater transparency with respect to the information our management uses to evaluate and compare the performance of our core operations and make operating decisions. This non-GAAP financial measure enables investors to see our business through the eyes of our management. However, there are limitations in the use of this non-GAAP financial measure in that it excludes certain operating expenses that are recurring in nature. In addition, our calculation of this non-GAAP financial measure may differ from the methodology used by other companies. The presentation of this non-GAAP financial measure should not be considered in isolation or as a substitute for our financial results prepared in accordance with GAAP. A reconciliation of net income, the most directly comparable GAAP financial measure, to non-GAAP earnings can be found in the table above under the heading, Non-GAAP Earnings. 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, our prospects following the launches of our Remunity Pump for Remodulin and Tyvaso for patients with PH-ILD, our expectations concerning the timing and success of our efforts to obtain the necessary FDA approvals to launch Tyvaso DPI, statements regarding our research and development plans related to the PERFECT and TETON studies of Tyvaso, the ADVANCE studies of ralinepag, and our organ transplantation programs, and our expectation that we will sustain our success in the long-term. 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. These risks include, in particular, the risk that we will not obtain the necessary FDA approvals to launch Tyvaso DPI. 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 August 4, 2021, 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. ORENITRAM, REMODULIN, REMUNITY, TYVASO, and UNITUXIN are registered trademarks of United Therapeutics Corporation and its subsidiaries. TYVASO DPI is a trademark of United Therapeutics Corporation. ADCIRCA is a registered trademark of Eli Lilly and Company. Contact: Dewey Steadman Phone: (202) 919-4097 Email: ir@unither.com View original content: SOURCE United Therapeutics Corporation Company Codes: NASDAQ-NMS:UTHR