SOLVE FSHD and Modalis Announce Strategic Collaboration to Develop an Innovative CRISPR-Based Epigenome Editing Treatment for Facioscapulohumeral Muscular Dystrophy

SOLVE FSHD and Modalis Announce Strategic Collaboration to Develop an Innovative CRISPR-Based Epigenome Editing Treatment for Facioscapulohumeral Muscular Dystrophy




SOLVE FSHD and Modalis Announce Strategic Collaboration to Develop an Innovative CRISPR-Based Epigenome Editing Treatment for Facioscapulohumeral Muscular Dystrophy

VANCOUVER, British Columbia & TOKYO & WALTHAM, Mass.–(BUSINESS WIRE)–SOLVE FSHD, a venture philanthropy organization dedicated to accelerating treatments for facioscapulohumeral muscular dystrophy (FSHD), and Modalis Therapeutics Corporation (TSE 4883; “Modalis”), a CRISPR-based epigenome editing therapeutics company focused on rare genetic diseases, today announced a strategic collaboration to develop an innovative therapy for FSHD, a debilitating muscular disorder affecting approximately 1 million individuals worldwide. The novel therapy leverages Modalis’s proprietary CRISPR-GNDM® (Guide Nucleotide-Directed Modulation) technology, which can dynamically modulate gene expression without introducing double-strand DNA breaks.


SOLVE FSHD will provide strategic funding to support the development of Modalis’s MDL-103 program. MDL-103 is an innovative therapeutic solution that continuously suppresses the expression of the DUX4 gene, the toxic disease-causing gene for FSHD, which becomes abnormally activated due to epigenetic changes in the D4Z4 repeat region on chromosome 4. MDL-103 is designed to have durable activity over long periods of time under the control of a strong, muscle-specific promoter, and is delivered to the muscles of patients using a muscle-tropic AAV delivery system. Modalis’s CRISPR-GNDM® technology has the potential to transform the treatment of FSHD by epigenetically silencing the expression of DUX4.

“SOLVE FSHD is pleased to partner with Modalis and to add them to our diverse portfolio of collaborators that are advancing potential therapies for FSHD,” stated Eva Chin, Executive Director of SOLVE FSHD. “SOLVE FSHD identified Modalis as a company committed to finding a cure for this debilitating condition. We were impressed by their unique approach to targeting the epigenetic cause of FSHD, using a platform technology that has shown promise in other neuromuscular diseases. We believe that the support from SOLVE FSHD will allow Modalis to accelerate the advancement of MDL-103 into clinical trials.”

“We are delighted to be working in partnership with SOLVE FSHD and greatly appreciate the invaluable support for the development of MDL-103,” said Haru Morita, CEO of Modalis. “This strategic collaboration is a strong validation of Modalis’s CRISPR-GNDM® technology and our MDL-103 program. As a pioneer in this technology, we have demonstrated promising long-term drug efficacy in mouse models, shown durable target engagement and safety in non-human primates, and exhibited excellent biodistribution in neuromuscular disorders. We believe that MDL-103, which incorporates CRISPR-GNDM® technology with a muscle tropic AAV delivery system, has significant potential as a breakthrough treatment for FSHD.”

About SOLVE FSHD

SOLVE FSHD is a venture philanthropic organization established to catalyze innovation and accelerate key research in finding a cure for FSHD. Established by renowned Canadian entrepreneur and philanthropist, Chip Wilson, the Wilson family has committed $100 million to kick-start funding into projects that support the organizations’ mission to solve FSHD by 2027. The goal of SOLVE FSHD is to find a solution that can slow down or stop muscle degeneration, increase muscle regeneration and strength, and improve the quality of life for those living with FSHD, visit https://www.solvefshd.com.

About Modalis Therapeutics Corporation

Modalis was founded in 2016 and conducts research and development activities in Massachusetts, USA. Modalis is a pioneering leader in the field of epigenetic medicine. Modalis develops therapeutics for patients suffering from serious genetic disorders such as neuromuscular diseases, CNS diseases, and cardiomyopathies. Modalis’s proprietary CRISPR-GNDM® technology is capable of specifically up or down modulating the expression of disease-relevant genes without introducing double-strand DNA breaks. For more information, visit https://www.modalistx.com/en/.

Contacts

SOLVE FSHD

Alexandra Grant, House of Wilson

alexandrag@hofw.com

Modalis Therapeutics Corporation

Corporate Planning Department

media@modalistx.com

Aethera Biotech Forges Strategic Collaboration with China’s Shang Renée Skincare to Introduce CROP (Controlled Release of Optimized Plants) Patent Technology into Chinese Market

Aethera Biotech Forges Strategic Collaboration with China’s Shang Renée Skincare to Introduce CROP (Controlled Release of Optimized Plants) Patent Technology into Chinese Market




Aethera Biotech Forges Strategic Collaboration with China’s Shang Renée Skincare to Introduce CROP (Controlled Release of Optimized Plants) Patent Technology into Chinese Market

ROME–(BUSINESS WIRE)–Aethera Biotech officially announced a strategic partnership with Chinese premium skincare brand Shang Renée, marking the latter as Aethera Biotech’s first collaborative partner in the Chinese market. This collaboration not only introduces the internationally pioneering CROP patent technology to China but has also led to the joint establishment of the CELL Laboratory in Italy, laying a robust foundation for scientific innovation in skincare.


CROP technology is an exclusive global patent held by Aethera Biotech. This innovation utilizes 100% natural laboratory cultivation to develop plant callus tissue cells (phytocomplexes), fully preserving the highly active components and regenerative properties of plants. The CELL Laboratory will focus on cellular research of core ingredients such as EchinAge CROP-G and other rare botanical specimens for Shang Renée, providing robust scientific support for the brand’s skincare formulations.

The EchinAge CROP-G compound, cultivated through this proprietary technology, exhibits elevated concentrations of modularized polyphenols and polysaccharides. Compared to conventional Echinacea extracts, EchinAge CROP-G demonstrates significantly enhanced polyphenolic content. Its dermatological efficacy manifests through three primary mechanisms:

  1. Rapid oxidative stress reduction via ROS suppression;
  2. Dual-targeted anti-inflammatory action through inhibition of iNOS and COX2 expression;
  3. Skin firming via attenuation of fibroblast-protective activity.

Clinically validated outcomes include measurable improvements in skin texture refinement and reduction of contour wrinkles, supported by comprehensive experimental data.

Centered on the philosophy of “Natural Regeneration,” Shang Renée is committed to delivering transformative solutions for skin repair, firming, and wrinkle reduction. This partnership will leverage Aethera Biotech’s expertise in plant cell cultivation, synergizing with active compounds like EchinAge CROP-G to develop groundbreaking skincare innovations.

The CEO of Aethera Biotech stated: “We are thrilled to deepen our collaboration with Shang Renée. Through joint research at the CELL Laboratory, we aim to translate avant-garde plant cell technologies into tangible skincare advancements, offering Chinese consumers purer and more efficacious skincare experiences.”

Contacts

Claire Chan

service@shangrenee.com

Otsuka Sibeprenlimab Phase 3 Data Show a Statistically Significant and Clinically Meaningful Proteinuria Reduction for the Treatment of Immunoglobulin A Nephropathy (IgAN)

Otsuka Sibeprenlimab Phase 3 Data Show a Statistically Significant and Clinically Meaningful Proteinuria Reduction for the Treatment of Immunoglobulin A Nephropathy (IgAN)




Otsuka Sibeprenlimab Phase 3 Data Show a Statistically Significant and Clinically Meaningful Proteinuria Reduction for the Treatment of Immunoglobulin A Nephropathy (IgAN)

  • In the Phase 3 VISIONARY study, sibeprenlimab achieved a statistically significant and clinically meaningful 51.2% (P<0.0001) reduction in proteinuria at nine months of treatment when compared to placebo
  • The safety profile of sibeprenlimab was favorable and consistent with previously reported data
  • Immunoglobulin A nephropathy is a progressive, immune-mediated, chronic kidney disease that can lead to end-stage kidney disease (ESKD) over the lifetime of most patients under current optimized standard care
  • Sibeprenlimab filed its Biologics License Application (BLA) and received Priority Review designation from the U.S. Food and Drug Administration (FDA) with a target action date of November 28th, 2025

PRINCETON, N.J. & TOKYO–(BUSINESS WIRE)–Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) today presented results from a pre-specified interim analysis of the Phase 3 VISIONARY study (NCT05248646) evaluating sibeprenlimab, for the treatment of immunoglobulin A nephropathy (IgAN) in adults. Patients treated with sibeprenlimab achieved a 51.2% (P<0.0001) reduction in proteinuria (as measured by 24-hour uPCR [urine protein-to-creatinine ratio]) at nine months of treatment when compared to placebo1. The data were presented during a late-breaking clinical trials session at the European Renal Association (ERA) Congress in Vienna, Austria. The study, the largest Phase 3 IgAN trial conducted to date, also showed the safety profile of sibeprenlimab was favorable and consistent with previously reported data1. Specifically, 76.3% of patients treated with sibeprenlimab experienced any Treatment Emergent Adverse Event (TEAE) versus 84.5% in the placebo group.1 Patients who experienced a serious TEAE were 3.9% treated with sibeprenlimab compared to 5.4% treated with placebo.


Sibeprenlimab received Priority Review designation from the FDA last month following its BLA filing in March. Proteinuria reduction is a recognized surrogate marker correlating with delaying progression to kidney failure and has been used as an endpoint in IgAN clinical trials to support accelerated regulatory approvals2.

Sibeprenlimab is an investigational monoclonal antibody that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with IgAN. APRIL plays a key role in the 4-hit process of IgAN pathogenesis and is an important initiating and sustaining factor in IgAN progression by promoting the production of pathogenic Gd-IgA1 and immune complex formation3,4,5,6. By selectively binding and inhibiting APRIL, sibeprenlimab reduces the amount of immunoglobulin A (IgA) and Gd-IgA1 levels1. Lower levels of Gd-IgA1 in people with IgAN provide less substrate for immune complex formation7. Sibeprenlimab is administered in a single-dose prefilled syringe for subcutaneous injection every four weeks intended for self-administration or administration by caregiver, providing patients the option of convenience at home.

“We are confident about the potential of sibeprenlimab and are grateful to the patients who are helping to further the science by participating in these important trials,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. “Proteinuria control is an important independent predictor for long-term prognosis, and this interim data reinforces our belief that selectively targeting APRIL has the potential to be an effective and safe approach for this progressive and irreversible kidney disease.”

The VISIONARY study continues in a blinded manner to evaluate the change in kidney function over 24 months as measured by estimated glomerular filtration rate (eGFR) and is expected to be completed in early 2026. Further prespecified and exploratory analyses of the data will be conducted to determine the full potential of sibeprenlimab for the treatment of IgAN1.

“The VISIONARY Phase 3 interim analysis shows a robust proteinuria reduction of 51.2% in the group treated with sibeprenlimab relative to placebo. These results affirm our belief in the efficacy of sibeprenlimab in the largest Phase 3 IgAN trial to date. The study enrolled a diverse patient population reflective of the disease epidemiology,” said Dr. Dana Rizk, professor of medicine in the division of nephrology at the University of Alabama at Birmingham. “The safety data emerging from VISIONARY is reassuring and adds to our existing knowledge about sibeprenlimab’s safety profile from prior programs. This is very exciting news for patients and adds a therapeutic option with a novel mechanism of action potentially targeting the immunologic pathogenesis of IgAN.”

About the VISIONARY Study

The VISIONARY study is the largest IgAN trial to date, and is a multicenter, randomized, double-blind, placebo-controlled trial consisting of approximately 510 adult patients with IgAN who were receiving standard-of-care therapy (defined as maximally tolerated ACE inhibitor or ARB +/- SGLT2 inhibitor), designed to evaluate the efficacy and safety of sibeprenlimab 400 mg administered subcutaneously every four weeks, compared to placebo1. The primary efficacy endpoint is to evaluate the change in 24-hour uPCR at 9 months compared with baseline. The secondary endpoint is to evaluate the annualized slope of eGFR estimated over ~24 months1.

About Sibeprenlimab

Sibeprenlimab (formerly VIS649) was designed and engineered by Visterra, Inc., a wholly owned subsidiary of Otsuka. Pre-clinical and early-stage trials of sibeprenlimab were also conducted by Visterra. Sibeprenlimab is an investigational monoclonal antibody that selectively binds to and inhibits the activity of APRIL and plays a key role in the 4-hit process. By selectively binding and inhibiting APRIL, sibeprenlimab reduces the amount of immunoglobulin A (IgA) and Gd-IgA1 levels1. Lower levels of Gd-IgA1 in people with IgAN provide less substrate for immune complex formation7. Decreased immune complex formation should result in diminished deposition in the kidney, and reduced proteinuria and kidney inflammation8. By reducing the production of Gd-IgA1, sibeprenlimab may help slow kidney damage and progression toward ESKD3,4,5,6. By inhibiting APRIL, sibeprenlimab may help address one of the IgAN-specific drivers for nephron loss.

About IgAN and APRIL

IgAN is a progressive, immune-mediated, chronic kidney disease that typically manifests in adults aged 20-40 years and leads to ESKD over the lifetime of most patients9,10,11.

IgAN is characterized by the accumulation of Gd-IgA1 complexes in the kidneys. IgAN can lead to progressive loss of kidney function and, eventually, ESKD, imposing a significant burden on patients10. Despite supportive care, there is an unmet need for treatments that address the root causes of the condition. Continued research in the disease remains crucial to uncovering opportunities for advancement in our understanding and treatment of patients 5.

APRIL, a cytokine in the tumor necrosis factor (TNF) family, is integral to the pathogenesis and progression of IgAN. It promotes the survival and class switching of B cells to produce IgA, particularly the pathogenic galactose-deficient IgA1 (Gd-IgA1) that forms immune complexes in the kidneys5.

About Otsuka

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: Otsuka–people creating new products for better health worldwide. Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies’ 2,250 employees in the U.S. develop and commercialize medicines in the areas of mental health and nephrology, using cutting-edge technology to address unmet healthcare needs.

OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Co., Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 35,340 people worldwide and had consolidated sales of approximately USD 14.7 billion in 2024.

All Otsuka stories start by taking the road less traveled. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on LinkedIn and Twitter at @OtsukaUS. Otsuka Pharmaceutical Co., Ltd.’s global website is accessible at https://www.otsuka.co.jp/en/.

About Visterra

Visterra is a biologics research and early-stage clinical development biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with immune-mediated kidney diseases and other hard-to-treat diseases. Its proprietary Hierotope® platform enables the design and engineering of precision biologics-based product candidates that specifically bind to, and modulate, key disease targets that are not adequately addressed by traditional therapeutic approaches. The platform also includes Fc engineering capabilities for half-life extension, bispecific antibodies and antibody-drug conjugates (ADCs). Visterra’s pipeline includes programs targeting kidney diseases, immunologically-driven diseases and infectious diseases. Visterra is an indirect subsidiary of Otsuka Pharmaceutical Co., Ltd. For more information, visit www.visterrainc.com.

References

  1. Otsuka Pharmaceutical Development & Commercialization, Inc.Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN). Clinicaltrials.gov. https://www.nejm.org/doi/full/10.1056/NEJMoa2305635
  2. Thompson A, Carroll K, Inker LA, et al. Proteinuria Reduction as a Surrogate End Pointin Trials of IgA Nephropathy. Clin J Am Soc Nephrol. 2019;14(3):469-481.doi:10.2215/CJN.08600718
  3. Mathur M, Barratt J, Suzuki Y, et al. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VIS649 (Sibeprenlimab), an APRIL-Neutralizing IgG2 Monoclonal Antibody, in Healthy Volunteers. Kidney Int Rep. 2022;7(5):993-1003.
  4. Chang S, Li XK. The Role of Immune Modulation in Pathogenesis of IgA Nephropathy (nih.gov)
  5. Cheung CK, Barratt J, Liew A, Zhang H, Tesar V, Lafayette R. The role of BAFF and April in IGA nephropathy: Pathogenic mechanisms and targeted therapies. Frontiers in nephrology. February 1, 2024.
  6. Mathur M, Barratt J, Chacko B, et al. A Phase 2 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy Patients. NEJM. 2023 https://www.nejm.org/doi/full/10.1056/NEJMoa2305635
  7. Gharavi, Ali G, et al. “Aberrant Iga1 Glycosylation Is Inherited in Familial and Sporadic IGA Nephropathy.” Journal of the American Society of Nephrology : JASN, U.S. National Library of Medicine, May 2008, pmc.ncbi.nlm.nih.gov/articles/PMC2386728
  8. Kant, Sam, et al. “Advances in Understanding of Pathogenesis and Treatment of Immune-Mediated Kidney Disease: A Review – American Journal of Kidney Diseases.” American Journal of Kidney Diseases, Apr. 2022, www.ajkd.org/article/S0272-6386(21)00835-0/fulltext.
  9. Pitcher, D. Braddon, et. al Long-term outcomes in IGA nephropathy. Clinical journal of the American Society of Nephrology : CJASN. https://pubmed.ncbi.nlm.nih.gov/37055195/.
  10. Lai K. Iga nephropathy. Nature reviews. Disease primers. 2016
  11. Cheung, Chee Kay & Boyd, JKF & Feehally, J.. (2012). Evaluation and management of IgA nephropathy. Clinical Medicine. 12. s27-s30. 10.7861/clinmedicine.12-6-s27.

Contacts

Contacts for Media

Otsuka in the U.S.

Robert Murphy

Corporate Communications

Otsuka America Pharmaceutical, Inc.

robert.murphy@otsuka-us.com

+1 609 249 7262

Otsuka in Japan

Jeffrey Gilbert

Leader, Pharmaceutical PR

Otsuka Pharmaceutical Co., Ltd.

gilbert.jeffrey.a@otsuka.jp

+81 3 6361 7379

RAD 2025: Long-Term Data on Nemluvio® (nemolizumab) Demonstrate its Favorable Safety Profile and Sustained and Increased Improvements in Itch and Skin Lesions in Patients With Atopic Dermatitis up to Two Years

RAD 2025: Long-Term Data on Nemluvio® (nemolizumab) Demonstrate its Favorable Safety Profile and Sustained and Increased Improvements in Itch and Skin Lesions in Patients With Atopic Dermatitis up to Two Years




RAD 2025: Long-Term Data on Nemluvio® (nemolizumab) Demonstrate its Favorable Safety Profile and Sustained and Increased Improvements in Itch and Skin Lesions in Patients With Atopic Dermatitis up to Two Years

  • New interim two-year data from a long-term extension study of Nemluvio in atopic dermatitis reinforce its rapid onset of action and demonstrate its lasting impact across multiple clinical and patient reported outcomes including itch and skin lesions1
  • Results build on data from the phase III ARCADIA program, showing Nemluvio’s consistent safety profile and sustained and increased improvements in efficacy outcomes in atopic dermatitis patients during prolonged treatment up to two years1,2
  • Two-year data from a long-term extension study of Nemluvio in prurigo nodularis will also be presented later in June at the International Congress of Dermatology

ZUG, Switzerland–(BUSINESS WIRE)–Galderma (SIX: GALD) today announced two-year data from a new interim analysis of a long-term extension study investigating the safety and efficacy of Nemluvio in moderate-to-severe atopic dermatitis. The data show that Nemluvio is well tolerated, with no new safety signals identified, reinforcing its rapid onset of action and demonstrating sustained and increased improvements in symptoms including itch and skin lesions with prolonged treatment up to two years.1 These data will be presented in a late-breaker abstract at the Revolutionizing Atopic Dermatitis (RAD) Conference, taking place from June 6-7, 2025.


 

“With Nemluvio now being launched in several countries, it’s so encouraging that we continue to see its robust evidence base expand. Long-term data is pivotal to this, highlighting the profound impact this innovative treatment can have in atopic dermatitis well into the future.”

BALDO SCASSELLATI SFORZOLINI, M.D., PHD.

GLOBAL HEAD OF RESEARCH & DEVELOPMENT

GALDERMA

 

 

Atopic dermatitis affects more than 230 million people worldwide.3 Often reported as one of patients’ most problematic symptoms, 87% of people with atopic dermatitis say they are seeking freedom from itch, with speed of itch relief therefore also prioritized by both patients and physicians.4-7 Nemluvio is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31.3,8,9 IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in atopic dermatitis.8,10 Nemluvio is also the first and only biologic approved for atopic dermatitis as well as prurigo nodularis with four-week dosing intervals from the start of treatment, and the only option to move to eight-week dosing intervals for appropriate patients with atopic dermatitis.9

 

“The relentless itch of atopic dermatitis is not just a symptom; it’s a constant burden that disrupts sleep, concentration, and the simple joys of life. Nemolizumab has demonstrated its impact on both itch and skin lesions in atopic dermatitis extensively over the years, and these new data, demonstrating its benefit up to two years, add another layer of confidence to that.”

PROFESSOR JONATHAN SILVERBERG
LEAD INVESTIGATOR OF THE ARCADIA CLINICAL PROGRAM, PROFESSOR OF DERMATOLOGY, GEORGE WASHINGTON UNIVERSITY SCHOOL OF MEDICINE AND HEALTH SCIENCES, UNITED STATES

 

 

The ARCADIA long-term extension study was designed to assess the long-term safety and efficacy of Nemluvio in patients with moderate-to-severe atopic dermatitis up to five years and includes more than 1,900 patients who either completed the initial or maintenance period in ARCADIA 1 or 2, a previous phase II/IIIb study, or were newly enrolled adolescent patients.1

Results to be presented at the RAD Conference will show that Nemluvio is associated with sustained and increased improvements in skin lesions, itch, sleep, and quality of life during prolonged treatment up to two years.1 At week 104 in evaluable patients, the interim analysis shows that:

  • More than 85% achieved a 75% reduction in the Eczema Area and Severity Index (EASI)1
  • Approximately 85% and 70% achieved an at least four-point improvement in itch, and being itch free or nearly itch free, respectively, when assessed using the SCORing Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Pruritus score. Improvements in sleep mirrored those in itch1
  • Approximately 60% reached clearance or almost-clearance of skin lesions when assessed using the Investigator’s Global Assessment (IGA) score1
  • Patients’ quality of life improved over time, as measured by the Dermatology Life Quality Index (DLQI)1

Results also reinforce Nemluvio’s rapid onset of action on itch and skin at Week 4, with 49% of patients who entered the long-term extension study naïve to Nemluvio achieving a 75% reduction in the EASI, and 69% achieving an at least four-point improvement in itch when assessed using the SCORAD VAS Pruritus score.1

Nemluvio was well tolerated in the long-term treatment of atopic dermatitis and no new safety signals were identified.1

Additional data from both the ARCADIA program in atopic dermatitis, as well as from the OLYMPIA open-label extension study in prurigo nodularis will be presented at RAD 2025, reinforcing Nemluvio’s rapid impact on key symptoms of atopic dermatitis, and its long-term efficacy in prurigo nodularis.11,12

Nemluvio was first approved in August 2024 by the United States Food and Drug Administration (U.S. FDA) for the treatment of adults with prurigo nodularis.9 In December 2024, it was also approved by the U.S. FDA for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.9 To date, Nemluvio is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world, including the European Commission. Additional regulatory submissions and reviews are ongoing.

More details on Galderma’s scientific presentations at RAD can be found here.

About Nemluvio

Nemluvio was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan. In Japan, nemolizumab is marketed as Mitchga® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients.13,14

About atopic dermatitis

Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions.3,15,16 It affects more than 230 million people worldwide.3 It is the most common inflammatory skin disease, impacting almost four times more people than psoriasis.17

Important Safety Information

Indications: NEMLUVIO® (nemolizumab-ilto) is a prescription medicine used:

  • to treat adults and children 12 years of age and older with moderate-to-severe eczema (atopic dermatitis or AD) in combination with prescription therapies used on the skin (topical) when the eczema is not well controlled by topical therapies alone. It is not known if NEMLUVIO is safe and effective in children with atopic dermatitis under 12 years of age.
  • to treat adults with prurigo nodularis. It is not known if NEMLUVIO is safe and effective in children with prurigo nodularis under 18 years of age.

Do not take NEMLUVIO if you are allergic to nemolizumab-ilto or to any ingredients in NEMLUVIO. Before taking NEMLUVIO, tell your healthcare provider about all of your medical conditions, including if you:

  • are scheduled to receive any vaccination. You should not receive a live vaccine right before or during treatment with NEMLUVIO.
  • are pregnant or plan to become pregnant. It is not known whether NEMLUVIO will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known whether NEMLUVIO passes into your breast milk and if it can harm your baby.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

NEMLUVIO may cause serious side effects, including: allergic reactions (hypersensitivity). Stop using NEMLUVIO and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:

  • Breathing problems or wheezing
  • Swelling of the face, lips, mouth, tongue, or throat
  • Fainting, dizziness, feeling lightheaded
  • Fast pulse
  • Swollen lymph nodes
  • Joint pain
  • Fever
  • Skin rash (red or rough skin)
  • Nausea or vomiting
  • General ill feeling
  • Cramps in your stomach area

The most common side effects of NEMLUVIO include:

  • Eczema: headache, joint pain, hives (itchy red rash or wheals), and muscle aches
  • Prurigo Nodularis: headache and skin rashes: atopic dermatitis (a type of eczema), eczema, and eczema nummular (scattered circular patches)

These are not all of the possible side effects of NEMLUVIO.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800- FDA-1088.

Please see full Prescribing Information including Patient Information.

About Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References

  1. Silverberg, JI, et al. Nemolizumab long-term safety and efficacy up to 104 weeks in the ARCADIA open-label extension study in adolescents and adults with moderate-to-severe atopic dermatitis. Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States.
  2. Silverberg J, et al. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 & 2): results from two replicate double-blinded, randomised controlled phase 3 trials. Lancet. 2024;404(10451):445-460. doi: 10.1016/S0140-6736(24)01203-0
  3. Langan SM, et al. Atopic dermatitis [published correction appears in Lancet. 2020;396(10253):758]. Lancet. 2020;396(10247):345-360. doi: 10.1016/S0140- 6736(20)31286-1
  4. Silverberg JI, et al. Patient burden and quality of life in atopic dermatitis in US adults: a population-based cross-sectional study. Ann Allergy Asthma Immunol. 2018;121(3):340-347. doi: 10.1016/j.anai.2018.07.006
  5. Augustin M, et al. Real-World Treatment Patterns and Treatment Benefits among Adult Patients with Atopic Dermatitis: Results from the Atopic Dermatitis Patient Satisfaction and Unmet Need Survey. Acta Derm Venereol. 2022;7:102:adv00830. doi: 10.2340/actadv.v102.3932
  6. Durno N, et al. Biologics and oral systemic treatment preferences in patients and physicians for moderate-to-severe atopic dermatitis: a discrete choice experiment in the United Kingdom and Germany. J Derm Treatment. 2024;35(1). doi: 10.1080/09546634.2024.2417966
  7. Penton H, et al. Assessing Response in Atopic Dermatitis: A Systematic Review of the Psychometric Performance of Measures Used in HTAs and Clinical Trials. Dermatol Ther (Heidelb). 2023;13(11):2549-2571. doi: 10.1007/s13555-023-01038-3
  8. Silverberg JI, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1):173-182. doi: 10.1016/j.jaci.2019.08.013
  9. Nemluvio U.S. Prescribing Information. Available online. Accessed May 2025
  10. Kwatra SG, Misery L, Clibborn C, Steinhoff M. Molecular and cellular mechanisms of itch and pain in atopic dermatitis and implications for novel therapeutics. Clin Transl Immunology. 2022;11(5):e1390. doi: 10.1002/cti2.1390
  11. Silverberg JI, et al. Nemolizumab was associated with rapid and significant improvements in itch and sleep in patients with moderate-to-severe atopic dermatitis: Results from two global phase 3 pivotal studies (ARCADIA 1 and ARCADIA 2). Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States.
  12. Yosipovitch G, et al. Nemolizumab long-term efficacy and safety up to 52 weeks in the OLYMPIA open-label extension study in patients with prurigo nodularis: An interim analysis. Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States.
  13. Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Accessed May 2025
  14. Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed May 2025
  15. Ständer S. Atopic dermatitis. N Engl J Med. 2021;384(12):1136-1143. doi:10.1056/NEJMra2023911
  16. Yang G, et al. Skin Barrier Abnormalities and Immune Dysfunction in Atopic Dermatitis. Int J Mol Sci. 2020;21(8):2867. doi: https://doi.org/10.3390/ijms21082867
  17. Raharja A, et al. Psoriasis: a brief overview. Clin Med (Lond). 2021;21(3):170-173. doi:10.7861/clinmed.2021-0257

Contacts

For further information:

Christian Marcoux, M.Sc.

Chief Communications Officer

christian.marcoux@galderma.com
+41 76 315 26 50

Richard Harbinson

Corporate Communications Director

richard.harbinson@galderma.com
+41 76 210 60 62

Céline Buguet 

Franchises and R&D Communications Director  

celine.buguet@galderma.com 

+41 76 249 90 87 

Emil Ivanov

Head of Strategy, Investor Relations, and ESG

emil.ivanov@galderma.com
+41 21 642 78 12

Jessica Cohen

Investor Relations and Strategy Director

jessica.cohen@galderma.com
+41 21 642 76 43

Canada’s Top Youth Scientists Awarded $1.3 Million at the 2025 Canada-Wide Science Fair in Fredericton

Canada’s Top Youth Scientists Awarded $1.3 Million at the 2025 Canada-Wide Science Fair in Fredericton




Canada’s Top Youth Scientists Awarded $1.3 Million at the 2025 Canada-Wide Science Fair in Fredericton

FREDERICTON, New Brunswick–(BUSINESS WIRE)–From groundbreaking schizophrenia treatment research to innovative sea turtle robots, Canada’s top young scientists showcased world-class research and innovation this week at the 63rd Canada-Wide Science Fair. At an awards ceremony this evening at the University of New Brunswick, 219 finalists were recognized with nearly $1.3 million in scholarships and awards at the country’s premier youth science, technology, engineering and mathematics (STEM) event. The fair’s Best Project Award in Discovery went to Sara Waqas from Calgary for her project, “Neurobiologically Informed Targeted Schizophrenia Treatment: A Multi-Omic, fMRI Approach”, while the Best Project in Innovation went to Evan Budz from Burlington, Ontario, for his project “Development of an Autonomous Bionic Sea Turtle Robot for Ecological Monitoring using AI”.




“This week, we’ve witnessed the power of youth curiosity in action,” said Reni Barlow, Executive Director at Youth Science Canada, organizers of the event. “Every student who undertakes a STEM project deserves to be celebrated for their dedication and creativity. Tonight’s winners are a powerful example of the impact youth can make through STEM.”

* * * * *

Top winners, selected by over 200 judges, include:

Best Project Awards

Best Project: Discovery

Sara Waqas from Calgary, Alberta, for Neurobiologically Informed Targeted Schizophrenia Treatment: A Multi-Omic, fMRI Approach.

Link to project

Best Project: Innovation

Evan Budz from Burlington, Ontario, for Development of an Autonomous Bionic Sea Turtle Robot for Ecological Monitoring using AI.

Link to project

Platinum Awards – Discovery
Best Junior (Grade 7/8)

Claire Sehn from Peterborough, Ontario, for Beat the Blaze: Preventing Wildfires and Drought With a Novel, Biodegradable Treatment.

Link to project

Best Senior (Grade 11/12/Cégep)

Hejin Wang from Saint John, New Brunswick, for Controlling Humongous Fungus: Cyanobacteria as a Biocontrol Agent for Root Rot Fungus.

Link to project

Platinum Awards – Innovation
Best Junior (Grade 7/8)

Trisha Haldar from Windsor, Ontario, for Visual Drug Interaction Checker.

Link to project

Best Senior (Grade 11/12/Cégep)

Chloe Rae Filion and Sophie Rose Filion from Fenwick, Ontario, for The Home Smog Alarm: How clean is your home’s air?

Link to project

* * * * *

The 2025 Canada-Wide Science Fair featured 390 student finalists, from Grade 7 through Cégep, showcasing 339 projects. The event drew more than 5,000 visitors and more than 30,000 online viewers. The Canada-Wide Science Fair and STEM Expo continue in person at the University of New Brunswick tomorrow, Friday, June 6, until 2:30 p.m. ADT, with projects remaining online for public viewing afterward.

The 64th edition of the Canada-Wide Science Fair will be held at the Edmonton EXPO Centre and the University of Alberta from May 23 to 30, 2026.

Members of the public are invited to meet the best project and platinum award winners on Friday, June 6, at 8:30 a.m. ADT in the Richard J. Currie Center at the University of New Brunswick. The panel discussion will also be broadcast live.

https://cwsf-espc.link/2025-meet-the-winners
Media members are encouraged to participate.

Winners will be available for media interviews throughout the week of June 9, 2025, by contacting Mary Moniz at mary@torchiacom.com.

Photos and videos, as well as the complete list of Canada-Wide Science Fair award recipients, are available here: CWSF 2025 Media Kit

About Youth Science Canada

Youth Science Canada empowers all Canadian youth to engage their curiosity in discovering and innovating through STEM projects. A registered charity incorporated in 1966, YSC delivers on its mission through national programs, including mySTEMspace, the National STEM Fair Network, Canada-Wide Science Fair, STEM Expo, Team Canada representation at international fairs and Smarter Science professional development for teachers. Through these programs, YSC directly supports the more than 500,000 students who do STEM projects in any given year. For more information, visit youthscience.ca.

Contacts

For more information:

Mary Moniz

Torchia Communications

www.torchiacom.com
647-278-0152

mary@torchiacom.com

Aline Bedros

Torchia Communications

www.torchiacom.com
514-250-2332

aline@torchiacom.com

JETRO and CIC to Showcase Promising Japanese Biotech Startups at “Japan Innovation Night” during BIO International Convention 2025 in Boston

JETRO and CIC to Showcase Promising Japanese Biotech Startups at “Japan Innovation Night” during BIO International Convention 2025 in Boston




JETRO and CIC to Showcase Promising Japanese Biotech Startups at “Japan Innovation Night” during BIO International Convention 2025 in Boston

BOSTON–(BUSINESS WIRE)–#accelerator–The Japan External Trade Organization (JETRO) and CIC Japan Desk will once again host “Japan Innovation Night: Best in Biotech” – a groundbreaking event showcasing the latest advancements in biotechnology from Japanese startups.




This exclusive gathering will take place on Wednesday, June 18th, 2025, from 5:30pm to 8pm in Venture Café at CIC Cambridge. This event provides a unique opportunity for U.S. venture capital firms and pharmaceutical companies, particularly those based in the Greater Boston Area, to explore potential partnerships and synergies with innovative Japanese biotech firms.

That same week, JETRO will also be organizing the Japan Pavilion at BIO International Convention 2025 in Boston; therefore, JETRO is pleased to bring several of the exhibiting startups to present their products in a more intimate setting at Japan Innovation Night. The event will feature ten carefully selected startups that will each be given three-minute pitches to present their latest innovations and partnering strategies and goals. A networking session will also be arranged for after the pitch session.

In 2024, the Japanese government updated its Bioeconomy Strategy, expressing its intent to step up its support for bioeconomy fields in Japan. This is on top of an already one trillion-yen budget measure enacted by the Japanese government in fiscal year 2022. The Bioeconomy Strategy underscores the Japanese government’s commitment to expanding Japan’s bioeconomy in the hopes of providing solutions to a myriad of societal and economic issues, from the environment to food to health and economic development.

In the Strategy, the Japanese government commits to enhancing the local startup ecosystem, ensuring its support aligns with the domestic biomanufacturing sector’s structure and the challenges its players face. By coordinating initiatives across government efforts, the Bioeconomy Strategy aims to establish environments that foster startup creation, growth, and R&D. JETRO will introduce innovative startups from this market at Japan Innovation Night. 

Full List of Japanese Startups:

https://www.jetro.go.jp/newsletter/SFC/2025/japan_innovation_night_2025_startup_list.pdf

Pre-Registration Here:

https://venturecafecambridge.org/event/japan-innovation-night-2025/

About JETRO

The Japan External Trade Organization (JETRO) is a Japanese government-affiliated agency that supports Japanese businesses expanding globally and international businesses entering Japan.

JETRO helps to facilitate collaboration and business alliances between Japanese and overseas companies via its business platform “J-Bridge.”

About CIC

CIC builds and operates a global network of innovation campuses where startups, scale-ups, corporations and public entities connect, work, and grow. Founded in 1999, CIC manages 1.5 million square feet of innovation-focused workspace, laboratories, and event space across North America, Europe and Asia. Additionally, CIC develops bespoke programming, builds and enables industry clusters, and provides world-class district consulting—all focused on advancing innovation.

Contacts

Ryota Hiramoto

JETRO New York

Ryota_Hiramoto@jetro.go.jp
1-212-997-0400

Tracer Biotechnologies Announces Strategic Partnership with QIAGEN to Advance Blood-Based MRD Testing for Solid Tumors

Tracer Biotechnologies Announces Strategic Partnership with QIAGEN to Advance Blood-Based MRD Testing for Solid Tumors




Tracer Biotechnologies Announces Strategic Partnership with QIAGEN to Advance Blood-Based MRD Testing for Solid Tumors

NEW YORK–(BUSINESS WIRE)–Tracer Biotechnologies, a leader in blood-based molecular diagnostics for cancer, is pleased to announce a strategic partnership with QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) to co-develop and commercialize minimal residual disease (MRD) assays for solid tumors on QIAGEN’s QIAcuity digital PCR platform.


This collaboration aims to deliver highly sensitive, cost-effective, and decentralized MRD testing solutions that enable oncologists to monitor cancer recurrence and guide personalized treatment decisions using minimally invasive blood samples.

“Partnering with QIAGEN enables Tracer to bring our solid tumor MRD expertise to a broader market using a robust digital PCR platform in QIAcuity,” said Mark Kaganovich, CEO of Tracer Biotechnologies. “With QIAcuity’s sensitivity and scalability, we can deliver high-quality companion diagnostics that integrate seamlessly into clinical workflows and offer new options to oncologists and patients.”

Tracer offers two complementary MRD solutions:

  • Tracer dPCR, a tumor-informed, multiplexed digital PCR assay that allows institutions to run bespoke MRD tests internally using their own digital PCR instruments;
  • Tracer WGS, an AI-powered whole-genome ctDNA platform that enables ultra-sensitive tumor-agnostic detection and tracking with no need for prior tissue.

“This new partnership represents an important step in further establishing QIAGEN’s major role in oncology. We are bringing innovative MRD technologies into drug development through our companion diagnostic partnerships,” said Jonathan Arnold, Vice President, Head of Partnering for Precision Diagnostics at QIAGEN. “In particular, we want to strengthen our scalable, cost-effective solutions based on our QIAcuity digital PCR system and enable our pharmaceutical partners to use MRD insights for guiding personalized treatment decisions for cancer patients.”

Tracer’s mission is to turn every digital PCR machine and next-generation sequencer into a sensitive MRD assay—empowering institutions, pharmaceutical companies, and clinicians with the tools to decentralize testing, accelerate treatment decisions, and personalize cancer care.

About Tracer Biotechnologies

Tracer Biotechnologies is a molecular diagnostics company specializing in blood-based assays for cancer detection and monitoring. Our platform enables decentralized, high-performance MRD testing using either digital PCR or whole-genome sequencing—bringing precision oncology closer to the point of care. For more information visit www.tracerbio.com.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions, enabling customers to extract and gain valuable molecular insights from samples containing the building blocks of life. Our Sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies prepare these biomolecules for analysis while bioinformatics software and knowledge bases can be used to interpret data to find actionable insights. Automation solutions bring these processes together into seamless and cost-effective workflows. QIAGEN serves over 500,000 customers globally in Life Sciences (academia, pharma R&D and industrial applications, primarily forensics) and Molecular Diagnostics for clinical healthcare. As of March 31, 2025, QIAGEN employed approximately 5,700 people in over 35 locations worldwide. For more information, visit www.qiagen.com.

Contacts

communications@tracerbio.com

Immunome Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Immunome Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)




Immunome Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

BOTHELL, Wash.–(BUSINESS WIRE)–Immunome, Inc. (the “Company”) (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, announced today that on June 2, 2025, the Compensation Committee of the Company’s Board of Directors (the “Compensation Committee”) granted inducement awards consisting of non-statutory stock options to purchase an aggregate of 173,000 shares of common stock to 13 new employees under the Company’s 2024 Inducement Plan. The Compensation Committee approved the stock options as an inducement material to such employees’ employment in accordance with Nasdaq Listing Rule 5635(c)(4).


Each stock option has an exercise price per share equal to $9.06 per share, the Company’s closing sales price on June 2, 2025, and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the underlying shares vesting monthly thereafter over 36 months, subject to the new employees’ continued service relationship with the Company through the applicable vesting dates. The stock options are subject to the terms and conditions of the Company’s 2024 Inducement Plan and the terms and conditions of an applicable stock option agreement covering the grant.

About Immunome, Inc.

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs). Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors; IM-1021, a ROR1-targeted ADC which is currently in a Phase 1 trial; and IM-3050, a FAP-targeted radioligand, which recently received IND clearance. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors. For more information, visit www.immunome.com.

Contacts

Investor Contact
Max Rosett

Chief Financial Officer

investors@immunome.com

GlycoMimetics Stockholders Approve Proposed Merger with Crescent Biopharma and All Related Proposals

GlycoMimetics Stockholders Approve Proposed Merger with Crescent Biopharma and All Related Proposals




GlycoMimetics Stockholders Approve Proposed Merger with Crescent Biopharma and All Related Proposals

GlycoMimetics Board of Directors approves 1-for-100 reverse stock split

ROCKVILLE, Md.–(BUSINESS WIRE)–GlycoMimetics, Inc. (Nasdaq: GLYC) (“GlycoMimetics”) today announced that its stockholders have approved the proposed merger (the “Merger”) with Crescent Biopharma, Inc. (“Crescent”), along with all proposals related to the Merger. The proposals were voted upon at GlycoMimetics’ special meeting in lieu of the annual meeting of stockholders held on June 5, 2025 (the “Special Meeting”), including a reverse stock split of GlycoMimetics’ common stock to be effected at the discretion of the board of directors of GlycoMimetics (the “Board”) within the parameters approved by GlycoMimetics’ stockholders.

On June 5, 2025, following the Special Meeting, the Board approved a reverse stock split of GlycoMimetics’ common stock at a ratio of 1-for-100. Following the anticipated closing of the Merger, the combined company’s common stock is expected to begin trading on a post-reverse stock split basis on The Nasdaq Capital Market (“Nasdaq”) on June 16, 2025, under the new name “Crescent Biopharma, Inc.”, ticker symbol “CBIO”, CUSIP number 38000Q201 and ISIN number US38000Q2012.

The reverse stock split is expected to reduce the number of GlycoMimetics’ outstanding common stock from approximately 64.5 million shares to approximately 0.6 million shares. The number of shares of GlycoMimetics’ authorized common stock will not be affected by the reverse stock split. At the Special Meeting, GlycoMimetics’ stockholders approved an increase in the number of shares of GlycoMimetics’ authorized common stock from 150,000,000 shares to 175,000,000 shares in connection with the anticipated closing of the Merger. No fractional shares will be issued if, as a result of the reverse stock split, a stockholder would otherwise become entitled to a fractional share because the number of shares of GlycoMimetics common stock they hold before the reverse stock split is not evenly divisible by the split ratio. Instead, each stockholder will be entitled to receive a cash payment in lieu of such fractional share. The cash payment to be paid will be equal to the fraction of a share to which such stockholder would otherwise be entitled multiplied by the closing price per share as reported by The Nasdaq Stock Market LLC on June 12, 2025, the trading day prior to the date the charter amendment to effect the reverse stock split is expected to be filed with the Secretary of State of the State of Delaware (with such price proportionately adjusted to give effect to the reverse stock split).

As a result of the reverse stock split, proportionate adjustments will be made to the exercise prices and number of shares of GlycoMimetics’ common stock underlying GlycoMimetics’ outstanding equity awards. There will be no change to the par value per share.

Following the closing of the Merger, the combined company’s total issued and outstanding common stock is expected to be approximately 14.8 million shares, or approximately 25.3 million shares on a fully-diluted basis.

About GlycoMimetics, Inc.

GlycoMimetics is a late clinical-stage biotechnology company that was previously discovering and developing glycobiology-based therapies for cancers, including AML, and for inflammatory diseases. The company’s scientific approach was based on an understanding of the role that carbohydrates play in cell recognition. Its specialized chemistry platform can be used to discover small molecule drugs, known as glycomimetics, that alter carbohydrate-mediated recognition in diverse disease states, including cancers and inflammation. The company’s goal was to develop transformative therapies for diseases with high unmet medical need. Learn more at www.glycomimetics.com.

About Crescent Biopharma, Inc.

Crescent Biopharma, Inc. is a biotechnology company advancing novel precision-engineered molecules to advance care for patients with solid tumors. Crescent’s pipeline of three programs harnesses validated biology to accelerate the path to market for potentially best-in-class therapeutics. Crescent’s lead program is CR-001, a tetravalent PD-1 x VEGF bispecific antibody, and it is also advancing CR-002 and CR-003, antibody drug conjugates with topoisomerase inhibitor payloads for undisclosed targets. For more information, visit www.crescentbiopharma.com and follow Crescent on LinkedIn.

Forward-Looking Statements

Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the “safe harbor” provisions under the Private Securities Litigation Reform Act of 1995, concerning GlycoMimetics, Crescent, the proposed pre-closing financing and the proposed Merger between GlycoMimetics and Crescent (collectively, the “Proposed Transactions”) and other matters. These forward-looking statements include, but are not limited to: expectations related to anticipated timing of the closing of the Merger and satisfaction (or waiver) of closing conditions under the merger agreement; the combined company’s listing on Nasdaq after the closing of the proposed Merger; the number of shares of GlycoMimetics common stock that may be outstanding as a result of the reverse stock split; and expectations regarding the ownership structure of the combined company. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “opportunity,” “potential,” “can,” “goal,” “strategy,” “target,” “anticipate,” “achieve,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “plan,” “possible,” “project,” “should,” “will,” “would” and similar expressions (including the negatives of these terms or variations of them) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting GlycoMimetics, Crescent, the Proposed Transactions, or the reverse stock split will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond the control of GlycoMimetics and Crescent) or other assumptions that may cause actual results, outcomes or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the conditions to the closing or consummation of the Proposed Transactions are not satisfied; the risk that the proposed pre-closing financing is not completed in a timely manner or at all; uncertainties as to the timing of the consummation of the Proposed Transactions and the ability of each of GlycoMimetics and Crescent to consummate the transactions contemplated by the Proposed Transactions; risks related to GlycoMimetics’ continued listing on Nasdaq until closing of the Proposed Transactions and the combined company’s ability to remain listed following the Proposed Transactions; risks related to GlycoMimetics’ and Crescent’s ability to correctly estimate their respective operating expenses and expenses associated with the Proposed Transactions, as applicable, as well as uncertainties regarding the impact any delay in the closing of any of the Proposed Transactions would have on the anticipated cash resources of the resulting combined company upon closing and other events and unanticipated spending and costs that could reduce the combined company’s cash resources; the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the Proposed Transactions; the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the business combination between GlycoMimetics and Crescent; costs related to the Merger; as a result of adjustments to the exchange ratio, Crescent stockholders and GlycoMimetics stockholders could own more or less of the combined company than is currently anticipated; the outcome of any legal proceedings that may be instituted against GlycoMimetics, Crescent or any of their respective directors or officers related to the merger agreement or the transactions contemplated thereby; unexpected costs, charges or expenses resulting from the Proposed Transactions; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the Proposed Transactions; and those uncertainties and factors more fully described in filings with the Securities and Exchange Commission (the “SEC”), including reports filed on Form 10-K, 10-Q and 8-K, in other filings that GlycoMimetics makes and will make with the SEC in connection with the proposed Merger, including the proxy statement/prospectus, as well as discussions of potential risks, uncertainties, and other important factors included in other filings by GlycoMimetics from time to time, any risk factors related to GlycoMimetics or Crescent made available to you in connection with the Proposed Transactions, as well as risk factors associated with companies, such as Crescent, that operate in the biopharma industry. Should one or more of these risks or uncertainties materialize, or should any of GlycoMimetics’ or Crescent’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Neither GlycoMimetics nor Crescent undertakes or accepts any duty to release publicly any updates or revisions to any forward-looking statements. This press release does not purport to summarize all of the conditions, risks and other attributes of an investment in GlycoMimetics or Crescent.

No Offer or Solicitation

This press release and the information contained herein is not intended to and does not constitute (i) a solicitation of a proxy, consent or approval with respect to any securities or in respect of the Proposed Transactions or (ii) an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities pursuant to the Proposed Transactions or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except in accordance with the requirements of the Securities Act of 1933, as amended, or an exemption therefrom. Subject to certain exceptions to be approved by the relevant regulators or certain facts to be ascertained, no public offer will be made directly or indirectly, in or into any jurisdiction where to do so would constitute a violation of the laws of such jurisdiction, or by use of the mails or by any means or instrumentality (including without limitation, facsimile transmission, telephone and the internet) of interstate or foreign commerce, or any facility of a national securities exchange, of any such jurisdiction.

NEITHER THE SEC NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THE SECURITIES OR DETERMINED IF THIS PRESS RELEASE IS TRUTHFUL OR COMPLETE.

Contacts

GlycoMimetics Investor Contact:
Argot Partners

212-600-1902

Glycomimetics@argotpartners.com

Crescent Biopharma Investor Contact:
Amy Reilly

Chief Communications Officer

amy.reilly@crescentbiopharma.com
617-465-0586

Massive Bio Recognized in Two Key Categories on CB Insights’ AI Drug Research & Development Market Map

Massive Bio Recognized in Two Key Categories on CB Insights’ AI Drug Research & Development Market Map




Massive Bio Recognized in Two Key Categories on CB Insights’ AI Drug Research & Development Market Map

CHICAGO–(BUSINESS WIRE)–Massive Bio, a leader in AI-powered oncology patient recruitment and clinical trial matching, has been named in two pivotal categories on CB Insights’ latest AI Drug Research & Development Market Map. This recognition underscores Massive Bio’s innovative contributions to revolutionizing cancer care through advanced artificial intelligence solutions.




CB Insights’ market map highlights companies at the forefront of leveraging AI to accelerate drug discovery and development. Massive Bio’s inclusion in both the “Clinical Trial Matching” and “Patient Recruitment” categories reflects its dual impact on streamlining clinical trial processes and enhancing patient access to cutting-edge therapies.

“Being recognized by CB Insights in two critical categories is a testament to our team’s dedication to transforming oncology care,” said Selin Kurnaz, PhD, CEO and Co-Founder of Massive Bio. “Our AI-driven platform is designed to bridge the gap between patients and clinical trials, ensuring that individuals receive the most appropriate and timely treatments available.”

Arturo Loaiza-Bonilla, MD, Co-Founder and Chief Medical Officer, added, “This acknowledgment validates our commitment to integrating advanced AI technologies into clinical workflows. By optimizing trial matching and patient recruitment, we’re not only improving operational efficiencies but also enhancing patient outcomes in oncology.”

This recognition from CB Insights follows a milestone presence at ASCO25, where Arturo Loaiza-Bonilla presented a poster session on AI-powered clinical trial matching and participated in the ASCO/ESMO Joint Session, emphasizing international collaboration in oncology innovation. In addition, Selin Kurnaz was named a PCC Wayfinder, honoring her leadership in advancing equitable access and data-driven transformation in cancer care.

Massive Bio’s platform utilizes sophisticated algorithms and real-time data analytics to match cancer patients with suitable clinical trials, considering factors such as genetic profiles, treatment histories, and geographic locations. This approach has significantly increased trial enrollment rates and reduced the time required to identify eligible participants.

The company’s dual recognition by CB Insights highlights its comprehensive approach to addressing challenges in clinical trial enrollment and patient engagement. As the demand for personalized cancer treatments grows, Massive Bio continues to lead in providing scalable, AI-driven solutions that connect patients with life-saving clinical trials.

About Massive Bio

Massive Bio, co-founded by Selin Kurnaz, Arturo Loaiza-Bonilla, and Çağatay Çulcuoğlu, transforms the pharmaceutical value chain with AI-driven solutions. As an AI-enabled real-world data company, it streamlines the patient journey, enhances access to advanced treatment options, and optimizes clinical trials. Massive Bio collaborates with pharmaceutical companies, research organizations, and healthcare institutions worldwide. A founding member of the CancerX public-private partnership and participant in the Cancer Moonshot White House initiative, the company has received recognition from the National Cancer Institute and operates across 17 countries with a global team of over 100 employees. For more information, visit www.massivebio.com.

Contacts

Massive Bio

Mert Turkkan

Marketing Director

+1 646 461 4946

pr@massivebio.com