New real-world data elevating patient perspectives highlight the need for scientific advancement in maternal fetal immunology at ISUOG 2025

SPRING HOUSE, Pa., (September 3, 2025) – Johnson & Johnson (NYSE: JNJ) announced today that six abstracts, including an oral poster presentation, will be shared at the 35^th International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) World Congress from September 14 – 17 in Cancún, Mexico, spotlighting persistent unmet needs in maternal fetal immunology. Alloantibody diseases, such as HDFN and FNAIT, develop when maternal antibodies, or alloantibodies, produced by a pregnant person’s immune system, cross the placenta. In the case of HDFN, these alloantibodies attack the fetal red blood cells, while in FNAIT they attack the fetal or newborn platelets.^1,2 These conditions can have severe consequences for both the mother and the fetus. HDFN can lead to fetal anemia, while FNAIT can lead to thrombocytopenia and the risk of bleeding, all of which may result in lifelong implications for the fetus.^1,2

“For families navigating pregnancies affected by HDFN and FNAIT, the experience is often filled with fear and uncertainty and presents an additional burden of self-advocacy. Earlier diagnosis, greater awareness of the diseases and access to innovative therapies have the potential to transform outcomes for thousands of parents and newborns,” said Bethany Weathersby, Founder and Executive Director, The Allo Hope Foundation. “The new patient insights presented at ISUOG show patients feel the intense need to advocate for themselves in the face of fragmented care and uncertainty following diagnosis, reinforcing a critical need to transform care pathways so no patient has to navigate this journey feeling unsupported in the future.”

New real-world studies reveal lived realities of pregnancies affected by HDFN and FNAIT, exploring the treatment patterns and outcomes of intrauterine transfusions (IUTs), the standard of care used to manage HDFN, as well as the complex diagnosis journey patients experience with FNAIT.^3,4

“Despite the severity of these conditions, there are no approved therapeutics that are effective and have a proven safety profile to help address the serious health consequences of HDFN and FNAIT,” said Leonard L. Dragone, M.D., Ph.D., Disease Area Leader, Rheumatology and Autoantibody, Johnson & Johnson Innovative Medicine. “These new patient insights presented at ISUOG confirm the acute need for earlier diagnosis and intervention to deliver the care these patients deserve.”

Johnson & Johnson received U.S. FDA Breakthrough designation for nipocalimab in severe HDFN in February 2024, and Fast Track designations for nipocalimab in severe HDFN and FNAIT in July 2019 and March 2024, respectively.^5,6 The Phase 3 AZALEA trial is currently enrolling pregnant individuals who are at risk of severe HDFN.⁷ The Phase 3 FREESIA-1 and FREESIA-3 trials are currently enrolling pregnant individuals who are at risk of a FNAIT pregnancy.^8,9

The full list of accepted Johnson & Johnson abstracts is below.

Data presentation highlights: ISUOG – September 14-17

ABOUT HEMOLYTIC DISEASE OF THE FETUS AND NEWBORN (HDFN)
Hemolytic disease of the fetus and newborn (HDFN) is a rare disease in which the maternal alloantibodies cross the placenta during pregnancy and attack fetal red blood cells causing fetal anemia.^1,10 If not treated in a timely manner by a knowledgeable clinician, the anemic fetus may develop severe fetal hydrops with life-threatening consequences, such as heart failure and/or death.¹¹ After birth, infants may be affected by neonatal hyperbilirubinemia and persistent anemia requiring transfusions. In general, the severity of HDFN increases with each subsequent pregnancy.¹² Currently no non-surgical interventions are approved for pregnancies at high risk of severe HDFN in the U.S. Pregnancies affected by severe HDFN may necessitate repeated intrauterine transfusions (IUTs).¹³ According to guidelines published by the British Society of Hematology, IUTs are invasive procedures with a risk of fetal death of 1–3% per procedure and are only undertaken in specialized fetal medicine units with the requisite interventional skills and expertise.10 The most difficult to treat cases of HDFN are those that develop before 24 weeks gestational age, defined here as early-onset, due to high rates of IUT-related complications associated with mortality.¹⁴ It is estimated that up to 80 out of every 100,000 pregnancies are affected by HDFN.¹⁵

ABOUT FETAL NEONATAL ALLOIMMUNE THROMBOCYTOPENIA (FNAIT)
Fetal neonatal alloimmune thrombocytopenia (FNAIT) is a rare and potentially life-threatening alloimmune condition in which a pregnant person’s immune system develops antibodies against fetal or newborn platelet antigens, leading to thrombocytopenia (low platelet counts in the fetus or newborn).¹ FNAIT can result in severe bleeding complications for a fetus or newborn and is characterized by organ bleeding in the gastrointestinal tract, lungs, or eyes, and may result in lifelong disability or death.1 If a severe bleed occurs in the brain, termed intracranial hemorrhage (ICH), death or life-long neurologic effects could occur.¹ ICH occurs in up to 26% of untreated pregnancies with FNAIT. There are no approved therapies for FNAIT management and while conventional interventions like intravenous immunoglobulin (IVIG) can increase the chance of fetal and infant survival, there remains an immense need for approved treatments with demonstrated safety profiles.¹⁶ FNAIT is not routinely screened for during pregnancy and firstborn children with FNAIT are often only diagnosed postnatally.¹ It is estimated 1 in 1000 pregnancies are affected by FNAIT.^1,17

ABOUT NIPOCALIMAB
Nipocalimab is an investigational monoclonal antibody, designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies, potentially without impact on other immune functions.¹⁸ This includes autoantibodies and alloantibodies that underlie multiple conditions across three key segments in the autoantibody space including Rare Autoantibody diseases, Maternal Fetal diseases mediated by maternal alloantibodies, and Rheumatic Diseases.^{7,19,20,21,22,23,24,25,26} Blockade of IgG binding to FcRn in the placenta is also believed to limit transplacental transfer of maternal alloantibodies to the fetus.^27,28

The U.S. FDA and EMA have granted several key designations to nipocalimab in the Maternal Fetal segment:

• U.S. FDA Fast Track designation in hemolytic disease of the fetus and newborn (HDFN) and fetal neonatal alloimmune thrombocytopenia (FNAIT) in March 2024

• U.S. FDA Orphan drug status for FNAIT in December 2023

• U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 EU EMA Orphan medicinal product designation for HDFN in October 2019 and FNAIT in April 2025

ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.

Learn more at https://www.jnj.com/ or at https://innovativemedicine.jnj.com/

Follow us at @JNJInnovMed.

Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies.

CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

Footnotes
¹ National Library of Medicine. Hemolytic Diseases of the Newborn. StatPearls Publishing. 2023 Jan. Available at: https://www.ncbi.nlm.nih.gov/books/NBK557423/. Last accessed: August 2025.

² NORD. Fetal and Neonatal Alloimmune Thrombocytopenia. Published online July 2022. https://rarediseases.org/rare-diseases/fetal-and-neonatal-alloimmune-thrombocytopenia/.

³ Shea, L., Mangelaars, M., Yavuz, C., Moore, C., & Clifford, E. Qualitative patient experiences of hemolytic disease of the fetus and newborn (HDFN): Psychosocial impacts reported during an ongoing patient council. Abstract EP16.73 presented at the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) 2025 Congress, Cancun, Mexico.

⁴ Shea, L., Mangelaars, M., Vaughan, A., Moore, C., & Clifford, E. Qualitative patient experiences of fetal and neonatal alloimmune thrombocytopenia (FNAIT): Diagnostic and treatment challenges. Abstract EP16.32 presented at the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) 2025 Congress, Cancun, Mexico.

⁵ Johnson & Johnson. Johnson & Johnson’s nipocalimab granted U.S. FDA Breakthrough Therapy Designation for the treatment of individuals at high risk for severe hemolytic disease of the fetus and newborn (HDFN). Available at: https://www.jnj.com/media-center/press-releases/johnson-johnsons-nipocalimab-granted-u-s-fda-breakthrough-therapy-designation-for-the-treatment-of-individuals-at-high-risk-for-severe-hemolytic-disease-of-the-fetus-and-newborn-hdfn. Last accessed: August 2025.

⁶ Johnson & Johnson. Johnson & Johnson’s nipocalimab granted U.S. FDA Fast Track designation to reduce the risk of fetal neonatal alloimmune thrombocytopenia (FNAIT) in alloimmunized pregnant adults. Available at: https://www.jnj.com/media-center/press-releases/johnson-johnsons-nipocalimab-granted-u-s-fda-fast-track-designation-to-reduce-the-risk-of-fetal-neonatal-alloimmune-thrombocytopenia-fnait-in-alloimmunized-pregnant-adults. Last accessed: August 2025.

⁷ ClinicalTrials.gov. A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN) (AZALEA) NCT05912517. Available at: https://clinicaltrials.gov/study/NCT05912517. Last accessed: August 2025.

⁸ ClinicalTrials.gov. A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) (FREESIA-1) NCT06449651. Available at: https://clinicaltrials.gov/study/NCT06449651. Last accessed: August 2025.

⁹ ClinicalTrials.gov. A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) (FREESIA-3) NCT06533098. Available at: https://clinicaltrials.gov/study/NCT06533098. Last accessed: August 2025.

¹⁰ Hemolytic disease of the newborn. Medline Plus. Available at: https://medlineplus.gov/ency/article/001298.htm. Last accessed: August 2025.

¹¹ Boston Children’s Hospital. Hydrops Fetalis. Available at: https://www.childrenshospital.org/conditions/hydrops-fetalis. Last accessed: August 2025.

¹² Nationwide Children’s. Hemolytic Disease of the Fetus and Newborn (HDFN). Available at: https://www.nationwidechildrens.org/conditions/hemolytic-disease-of-the-fetus-and-newborn-hdfn. Last accessed: August 2025.

¹³ DeMoss, P., Asfour, M. and Hersey, K. Anti-K1 (Kell) antibody expressed in maternal breastmilk: A case report of a neonate with multiple intrauterine transfusions and postnatal exposure to Kell antibody in maternal breastmilk’, Case reports in pediatrics. 2017.

¹⁴ Linden burg IT, van Kamp IL, van Zwet EW, Middeldorp JM, Klumper FJ, Oepkes D. Increased perinatal loss after intrauterine transfusion for alloimmune anaemia before 20 weeks of gestation. BJOG. 2013 Jun;120(7):847-52.

¹⁵ Delaney M and Matthews D. Hemolytic disease of the fetus and newborn: managing the mother, fetus, and newborn. Hematology Am Soc Hematol Educ Program (2015) 2015 (1): 146–151.

¹⁶ Brojer E, Husebekk A, Dębska M, Uhrynowska M, Guz K, Orzińska A, Dębski R, Maślanka K. Fetal/Neonatal Alloimmune Thrombocytopenia: Pathogenesis, Diagnostics and Prevention. Arch Immunol Ther Exp (Warsz). 2016 Aug;64(4):279-90.

¹⁷ Lieberman L, Greinacher A, Murphy M, et al. Fetal and neonatal alloimmune thrombocytopenia: recommendations for evidence-based practice, an international approach. British Journal of Haematology. Volume 185, Issue 3. May 2019. Pages 549-562

¹⁸ Seth N, et al. Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties. mAbs. 2025 Feb; 17(1).

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