Be Biopharma

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Press Releases

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  • Oral presentation to feature nonclinical data for BE-102 for the potential treatment of hypophosphatasia
  • Poster to highlight potential of BCMs as an allogenic off-the-shelf therapy

CAMBRIDGE, Mass. April 28, 2025 – Be Biopharma, Inc. (“Be Bio”), a clinical-stage company pioneering the discovery and development of engineered B Cell Medicines (BCMs), today announced that it will present at the American Society of Gene and Cell Therapy (ASGCT) 28th Annual Meeting being held in New Orleans, May 13-17, 2025.  

Details regarding the Be Biopharma presentations at the conference are as follows:

Oral Presentation Title: Ex Vivo Gene Editing of Autologous B Cells Produce Sustained Levels of Tissue Nonspecific Alkaline Phosphatase In Vivo for the Potential Treatment of Hypophosphatasia 
Presenter: Hanlan Liu, Ph.D., MBA, SVP, Head of Late Research and NCD, Be Biopharma
Date: May 17, 2025
Presentation Time: 10:45 – 11:00 AM CT
Session Title: B-Cell and Solid Organ Therapies
Session Time: 10:15 AM – 12:00 PM CT
Session Room: 278-282

The oral presentation will include nonclinical data for Be Biopharma’s BE-102 program, a novel B cell therapy developed as a potential treatment of Hypophosphatasia (HPP). HPP is caused by deficiency of tissue-nonspecific alkaline phosphatase (TNSALP) activity, resulting from pathogenic mutations in the ALPL gene, which leads to multi-systemic clinical complications including deficient bone mineralization. Enzyme replacement therapy (ERT) is the only approved treatment for HPP which requires frequent lifelong injections. ERT is only available for perinatal/infantile- and juvenile-onset forms of HPP and weekly injections are associated with common side effects that can significantly affect a patient’s quality of life. BE-102 was developed to address these limitations. BE-102 is manufactured from primary human B cells by isolating, activating, and precision engineering with CRISPR/Cas9 followed by AAV-mediated delivery of a DNA donor template for the insertion of human ALPL gene into the CCR5 locus (a safe harbor locus). In vitro pharmacology results demonstrate that BE-102 secretes active TNSALP, which is capable of rescuing calcium deposit inhibited by inorganic pyrophosphate (PPi), a substrate which accumulates in people with HPP. In vivo studies were conducted in immune-deficient NOG-hIL6 mice, confirming long-term engraftment and continuous production of active TNSALP in vivo following a single IV administration of BE-102. Be Biopharma’s in vitro and in vivo pharmacology and safety data established nonclinical proof-of-concept that BE-102 has the potential to be a disease-modifying therapy for people with HPP by providing long-lasting active TNSALP, with the flexibility to be titratable and redosable as needed.

Poster Title: Exploration of Allogeneic Shielding Strategies by Precise CRISPR/Cas9 Genome Engineering of Primary Human B Cells to Enable Off-the-shelf B Cell Medicines for Sustained Delivery of in vivo Biologics
Presenter: Xuqing Zhang, Ph.D., Director, Immunology, Be Biopharma
Date: May 13, 2025
Time: 6:00 – 7:30 PM CT
Session Title: Tuesday Poster Reception 
Session Room: Poster Hall, Hall I2
Final Abstract Number: 777

The abstract highlights Be Biopharma’s approach using both in vitro and in vivo assays to determine the potential of B Cell Medicines (BCMs) as an allogeneic off-the-shelf cell therapy without additional engineering and ways to enhance hypoimmunogenicity via CRISPR/Cas9 genome engineering. The data demonstrates BCMs are immunologically stealthy and can be further engineered to evade host immune responses, opening the possibility of exploring them as off-the-shelf cellular therapies without HLA matching  for broader patient access.

About Engineered B Cell Medicines – A New Class of Cellular Medicines

The B cell is a powerful cell that produces thousands of proteins per cell per second at constant levels, and over decades. Precision genome editing can now be used to engineer B Cells that produce therapeutic proteins of interest, driving a new class of cellular medicines – Engineered B Cell Medicines (BCMs) – with the potential to be durable, allogeneic, redosable, and administered without pre-conditioning. The promise of BCMs could transform therapeutic biologics with broad application — across protein classes, patient populations and therapeutic areas.

About Be Biopharma

Be Biopharma (“Be Bio”) is pioneering Engineered B Cell Medicines (BCMs) to dramatically improve the lives of patients who are living with Hemophilia B and other genetic diseases, cancer, and other serious conditions. With eyes locked on the patient, our team of purpose-driven scientists, technologists, manufacturing experts and business builders collaborate to create a bold new class of cell therapies. Be Bio was founded in October 2020, and is backed by ARCH Venture Partners, Atlas Venture, RA Capital Management, Nextech, Alta Partners, Longwood Fund, Bristol Myers Squibb, Takeda Ventures, Seattle Children’s Research Institute, Pathway to Cures (the venture philanthropy fund for the National Bleeding Disorders Foundation) and others to re-imagine medicine based on the power of Engineered B cells. For more information, please visit us at Be.Bio and our LinkedIn page.

Investor Contact:
ir@be.bio

Media Contact:
media@be.bio

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Dr. Abu-Absi Brings 20+ Years of Operational and Manufacturing Experience in Biologics and Cell & Gene Therapy

CAMBRIDGE, Mass. March 3, 2025 – Be Biopharma, Inc. (“Be Bio”), a clinical-stage company pioneering the discovery and development of engineered B Cell Medicines (BCMs), today announced the appointment of Susan Abu-Absi, Ph.D., as Chief Operating Officer. With over 20 years of experience in strategic operations, product development and manufacturing in the biotechnology industry, Dr. Abu-Absi brings a wealth of knowledge and expertise to the role, positioning Be Bio for continued growth and operational excellence.

Dr. Abu-Absi’s career has been marked by her leadership in the development and manufacturing of biologics and cell and gene therapies, contributing to the approval of several key products, including Abecma, Zynteglo, Skysona, Yervoy and Opdivo. Dr. Abu-Absi most recently served as Chief Technology Officer at 2seventy bio, where she built the global manufacturing and supply infrastructure and managed strategic partnerships with academics, partner innovator companies and suppliers to enable the translation of four novel cell therapies into the clinic. Prior to that, she held leadership roles in technical and product development at bluebird bio, Bristol Myers Squibb and Bayer Healthcare. Dr. Abu-Absi holds a Ph.D. in Chemical Engineering from the University of Minnesota and a B.S. in Chemical Engineering from the University of Toledo.

“Susan is an outstanding leader and accomplished executive whose experience will further strengthen our leadership team as we solidify our position as a multi-program, clinical-stage company,” said Joanne Smith-Farrell, Ph.D., Chief Executive Officer. “She joins Be Bio at an ideal time, with enrollment now underway in the BeCoMe-9 trial for BE-101 in Hemophilia B, and with our development candidate, BE-102, progressing toward IND as a potential breakthrough for patients with Hypophosphatasia. We look forward to leveraging Susan’s expertise as we pioneer our B Cell Medicines to potentially transform the treatment landscape for a wide range of diseases.”

In conjunction with the appointment of Dr. Abu-Absi, Be Bio announced the departure of President & Chief Operating Officer Krishnan Viswanadhan, Pharm.D., who is leaving Be Bio to pursue another leadership position in the biotechnology industry.

“I would like to thank Krishnan for his invaluable contributions to Be Bio, especially his leadership in advancing our lead program, BE-101, to the clinic as a potentially game-changing therapy for people with Hemophilia B,” continued Dr. Smith-Farrell. “His dedication and impact have helped shape who we are today, and we are deeply grateful for his time with us. We wish him all the best in his next chapter.”

About Engineered B Cell Medicines – A New Class of Cellular Medicines

The B cell is a powerful cell that produces thousands of proteins per cell per second at constant levels, and over decades. Precision genome editing can now be used to engineer B Cells that produce therapeutic proteins of interest, driving a new class of cellular medicines – Engineered B Cell Medicines (BCMs) – with the potential to be durable, allogeneic, redosable, and administered without pre-conditioning. The promise of BCMs could transform therapeutic biologics with broad application — across protein classes, patient populations and therapeutic areas.

About Be Biopharma

Be Biopharma (“Be Bio”) is pioneering Engineered B Cell Medicines (BCMs) to dramatically improve the lives of patients who are living with Hemophilia B and other genetic diseases, cancer, and other serious conditions. With eyes locked on the patient, our team of purpose-driven scientists, technologists, manufacturing experts and business builders collaborate to create a bold new class of cell therapies. Be Bio was founded in October 2020, and is backed by ARCH Venture Partners, Atlas Venture, RA Capital Management, Nextech, Alta Partners, Longwood Fund, Bristol Myers Squibb, Takeda Ventures, Seattle Children’s Research Institute and others to re-imagine medicine based on the power of Engineered B cells. For more information, please visit us at Be.Bio and our LinkedIn page.

Investor Contact:
ir@be.bio

Media Contact:
media@be.bio

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  • Publication Demonstrates Engraftment of 20% of Infused Cells without Preconditioning with Consistent Distribution Upon Redosing
  • Manuscript Published in the Molecular Therapy Journal

CAMBRIDGE, Mass. February 6, 2025 – Be Biopharma, Inc. (“Be Bio”), a clinical-stage company pioneering the discovery and development of engineered B Cell Medicines (BCMs), today announced the publication in the journal Molecular Therapy of a manuscript highlighting first-of-its-kind preclinical research from a collaboration study showing homing and engraftment of ex-vivo-generated plasma cells in non-human primates (NHPs) with intact immune systems.  The study highlights the ability of these plasma cells to engraft in NHPs without preconditioning, validating a crucial aspect of the BCM platform designed to develop innovative programs with best-in-class profiles. The study was funded and conducted through a collaborative research and development agreement with the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health.

The publication, entitled “In vivo tracking of ex vivo generated 89Zr-oxine labeled plasma cells by PET in a non-human primate model”, summarizes a study designed to evaluate engraftment without preconditioning of ex vivo expanded NHP plasma cells. Plasma cells are terminally differentiated B cells which can live for decades and have the capacity to secrete extremely high levels of protein. In the study, B cells from two NHPs were collected, expanded 10-15 fold ex vivo, and differentiated into antibody-secreting plasma cells. Using radioactive labeling and PET/CT imaging to track the cells after infusion, researchers found that 20% of the cells engrafted into the plasma cell niche by 24 hours and high-resolution imaging of the bone marrow compartment showed cellular distribution comparable to human bone marrow. A second infusion in one of the subjects showed remarkably similar distribution patterns to the first infusion, suggesting the feasibility of predicable re-dosing.

“These findings demonstrate the incredible potential of engineered B cells as a therapeutic platform and validate engraftment without preconditioning, a key pillar of our platform,” said Richard Morgan, Ph.D., Chief Scientific Officer, Be Biopharma. “Our successful tracking and monitoring of these cells in non-human primates marks a crucial step toward developing B cell medicines that could potentially treat genetic disorders, metabolic diseases, and cancer. The safety profile and ability to perform repeated infusions are particularly encouraging and support our continued development of this innovative approach.”

A phase 1/2 clinical trial, the BeCoMe-9 trial, has been initiated for Be Bio’s lead program, BE-101, in people with Hemophilia B, and Be Bio expects to initiate clinical development for BE-102 for the treatment of hypophosphatasia during 2026.

To read the published article, please visit
https://www.cell.com/molecular-therapy-family/molecular-therapy/fulltext/S1525-0016(24)00842-6

Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About Engineered B Cell Medicines – A New Class of Cellular Medicines

The B cell is a powerful cell that produces thousands of proteins per cell per second at constant levels, and over decades. Precision genome editing can now be used to engineer B Cells that produce therapeutic proteins of interest, driving a new class of cellular medicines – Engineered B Cell Medicines (BCMs) – with the potential to be durable, allogeneic, redosable, and administered without pre-conditioning. The promise of BCMs could transform therapeutic biologics with broad application — across protein classes, patient populations and therapeutic areas.

About Be Biopharma

Be Biopharma (“Be Bio”) is pioneering Engineered B Cell Medicines (BCMs) to dramatically improve the lives of patients who are living with Hemophilia B and other genetic diseases, cancer, and other serious conditions. With eyes locked on the patient, our team of purpose-driven scientists, technologists, manufacturing experts and business builders collaborate to create a bold new class of cell therapies. Be Bio was founded in October 2020, and is backed by ARCH Venture Partners, Atlas Venture, RA Capital Management, Nextech, Alta Partners, Longwood Fund, Bristol Myers Squibb, Takeda Ventures, Seattle Children’s Research Institute and others to re-imagine medicine based on the power of Engineered B cells. For more information, please visit us at Be.Bio and our LinkedIn page.

Investor Contact:
ir@be.bio

Media Contact:
media@be.bio

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  • Financing includes participation from new investor Nextech1 along with existing investors Arch Venture Partners, Atlas Venture, RA Capital, Alta Partners, Longwood Fund, Bristol Myers Squibb, Takeda Ventures and Others
  • Proceeds will Advance BE-101 Through Clinical Proof-of-Concept and Progress BE-102 to the Clinic

CAMBRIDGE, Mass., January 15, 2025 – Be Biopharma, Inc. (“Be Bio” or “the Company”), a leader in B Cell Medicines (BCMs), today announced the closing of its $92M Series C financing. The round includes participation from new investor Nextech with existing investors including ARCH Venture Partners, Atlas Venture, RA Capital Management, Alta Partners, Longwood Fund, Bristol Myers Squibb, and Takeda Ventures, among others.  In conjunction with the financing, Melissa McCracken, Ph.D. of Nextech will join Be Bio’s Board of Directors.

The proceeds from the Series C financing will be used to generate clinical proof-of-concept for BE-101 in the ongoing BeCoMe-9 Phase 1/2 clinical trial for people with hemophilia B and to advance BE-102 for the treatment of hypophosphatasia to the clinic. Both programs are built on Be Bio’s BCM product platform, creating durable, titratable, and redosable therapeutics that require no preconditioning and produce sustained and constant levels of therapeutic proteins.

“With this funding in hand, we are well-equipped to advance our two lead programs and solidify our position as a multi-program, clinical-stage company,” said Joanne Smith-Farrell, Ph.D., Chief Executive Officer of Be Bio.  “We are on track to demonstrate clinical proof-of-concept for BE-101 in Hemophilia B this year.  Additionally, BE-102 is poised to enter the clinic next year, potentially demonstrating BCMs’ potential to become a new gold standard in enzyme replacement by providing hypophosphatasia patients with a transformative new option.  I am grateful to our existing and new investors, who share our vision that BCMs can transform the treatment landscape for a wide range of diseases with potentially best-in-class medicines.”

“We are excited to partner with Be Biopharma at this pivotal stage,” stated Melissa McCracken, Ph.D., Partner at Nextech.  “Be Bio has established itself as a leader in this field with their lead programs having best-in-class potential. We believe BCMs, as a class, could revolutionize treatment paradigms across indications . We look forward to supporting their groundbreaking work and witnessing the transformative impact on patient care.”

About Nextech Invest

Nextech is a global, therapeutics-focused venture capital firm headquartered in Zurich, Switzerland with offices in Boston and San Francisco, USA. Nextech invests in the most promising drug discovery companies primarily in oncology and adjacent diseases, with the potential to create multiple medicines. Nextech’s portfolio is focused throughout the US and Europe with investments from company inceptions to public financings. For more information, please visit: www.nextechinvest.com

About BE-101

BE-101 is a first-in-class BCM that is engineered to insert the human Factor IX (FIX) gene into primary human B cells, allowing for continuous expression of active FIX for the treatment of hemophilia B. BE-101 has the potential to express sustained therapeutic FIX activity levels with a single infusion while having the flexibility to be titrated and/or re-dosed, and without the need for preconditioning. The potential to maintain therapeutic FIX activity levels while the reducing dosing frequency associated with current FIX replacement regimens could address the considerable infusion burden associated with current therapies and potentially drive reductions in the annualized bleeding rates and FIX usage.  The US FDA cleared the BE-101 IND in May of 2024, and granted Fast Track designation in September of 2024.  The Phase 1/2 BeCoMe-9 Trial has been initiated and further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT06611436.

About BE-102

BE-102 is a first-in-class BCM that has been engineered using artificial intelligence-guided protein design to modify primary human B cells to produce ALP, an enzyme deficient in people living with HPP. A single infusion of BE-102 has the potential to express sustained therapeutic ALP with the flexibility to be titrated and/or re-dosed, if needed, and without the need for pre-conditioning. BE-102 has been selected as a Development Candidate and has the potential to transform the standard of care for people living with HPP.

About Engineered B Cell Medicines – A New Class of Cellular Medicines

The B cell is a powerful cell that produces thousands of proteins per cell per second at constant levels, and over decades. Precision genome editing can now be used to engineer B Cells that produce therapeutic proteins of interest, driving a new class of cellular medicines – Engineered B Cell Medicines (BCMs) – with the potential to be durable, allogeneic, redosable, and administered without pre-conditioning. The promise of BCMs could transform therapeutic biologics across protein classes, patient populations and therapeutic areas.

About Be Biopharma

Be Biopharma (“Be Bio”) is pioneering Engineered B Cell Medicines (BCMs) to dramatically improve the lives of patients who are living with Hemophilia B and other genetic diseases, cancer, and other serious conditions. With eyes locked on the patient, our team of purpose-driven scientists, technologists, manufacturing experts and business builders collaborate to create a bold new class of cell therapies. Be Bio was founded in October 2020, and is backed by ARCH Venture Partners, Atlas Venture, RA Capital Management, Nextech, Alta Partners, Longwood Fund, Bristol Myers Squibb, Takeda Ventures, Seattle Children’s Research Institute and others to re-imagine medicine based on the power of Engineered B cells. For more information, please visit us at Be.Bio and our LinkedIn page.

Investor Contact:
ir@be.bio

Media Contact:
media@be.bio

  1. Nextech Invest Ltd, on behalf of one or more funds managed by it.

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CAMBRIDGE, Mass. — Be Biopharma, Inc. (“Be Bio”), a clinical-stage company pioneering engineered B Cell Medicines (BCMs), today announced that Chief Executive Officer Joanne Smith-Farrell, Ph.D. will present at the 43rd Annual J.P. Morgan Healthcare Conference being held at the Westin St. Francis in San Francisco, CA on Wednesday, January 15, 2025, at 3:30 pm PT.

About Engineered B Cell Medicines – A New Class of Cellular Medicines

The B cell is a powerful cell that produces thousands of proteins per cell per second at constant levels, over decades. Precision genome editing can now be used to engineer B Cells that produce therapeutic proteins of interest, driving a new class of cellular medicines – Engineered B Cell Medicines (BCMs) – with the potential to be durable, allogeneic, redosable, titratable and administered without pre-conditioning. The promise of BCMs could transform therapeutic biologics with broad application — across diverse protein classes, patient populations and therapeutic areas.

About Be Biopharma

Be Biopharma (“Be Bio”) is clinical-stage company pioneering Engineered B Cell Medicines (BCMs) to dramatically improve the lives of patients who are living with Hemophilia B, other genetic diseases, cancer, and other serious conditions. With eyes locked on the patient, Be Bio’s team of purpose-driven scientists, technologists, manufacturing experts and business builders collaborates to create a bold new class of cell therapies. Be Bio was founded in October 2020, and is backed by ARCH Venture Partners, Atlas Venture, RA Capital Management, Alta Partners, Longwood Fund, Bristol Myers Squibb, Takeda Ventures, Seattle Children’s Research Institute and others. For more information, please visit us at Be.Bio and our LinkedIn page.

Investor Contact:
ir@be.bio

Media Contact:
media@be.bio

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  • BeCoMe-9 Trial Poster: Highlights ongoing Phase 1/2 trial evaluating BE-101, a first-in-class B cell medicine (BCM) designed to sustain Factor IX levels in adults with Hemophilia B.
  • Oral Presentation: Showcased breadth and versatility of ex-vivo precision gene-engineered BCM platform across genetic disease and oncology

CAMBRIDGE, Mass. December 8, 2024 – Be Biopharma, Inc. (“Be Bio”), a clinical-stage company pioneering engineered B Cell Medicines (BCMs), today announced two key updates at the 66th ASH Annual Meeting in San Diego, CA. These updates include a Trial in Progress poster detailing the BeCoMe-9 clinical trial and an oral presentation highlighting the potential of Be Bio’s BCM platform to create innovative programs with best-in-class profiles.

The Trial in Progress poster highlights the design of Be Bio’s BeCoMe-9 clinical trial, evaluating BE-101 in patients with Hemophilia B. BE-101, the Company’s lead clinical program, is an autologous BCM therapy engineered to express human factor IX (hFIX). This innovative therapy aims to offer a transformative new therapeutic option by delivering sustained hFIX levels, addressing the needs in patients with hemophilia B, a bleeding disorder affecting approximately 40,000 people globally. Despite advancements, many people living with hemophilia B continue to experience regular bleeding events that can lead to chronic pain and irreversible joint damage. BE-101 is designed to provide long-lasting FIX protection using the patient’s own B cells, with the flexibility to be titratable and redosable as needed. The BeCoMe-9 first-in-human Phase 1/2 trial is actively enrolling patients and aims to achieve clinical proof of concept for both BE-101 and the BCM platform. BE-101 has been granted Orphan Drug and Fast Track Designations by the FDA, underscoring its potential to address important unmet needs.

“This year marks a pivotal milestone for Be Bio as we have transitioned into a clinical stage company, advancing our groundbreaking science into lead programs that aim to deliver new therapeutic options for patients in need,” said Joanne Smith-Farrell, PhD, Chief Executive Officer of Be Bio. “In 2025, the BeCoMe-9 trial is poised to generate clinical proof of concept for BE-101, advancing this critical program for patients while demonstrating the transformative potential of our B Cell Medicine platform.”

The BeCoMe-9 study is designed to evaluate the safety and clinical activity of a single IV dose of BE-101 in adults with moderately severe or severe Hemophilia B. The study consists of two parts. Part 1 employs an ascending-dose design, enabling the stepwise evaluation of increasing dose levels to determine a safe and effective dose. Once this dose is identified, Part 2 will add a cohort to confirm and further characterize the safety and activity of BE-101 at the selected dose along with a cohort to include adolescents. Details of the poster presentation are as follows:

Abstract Title: BeCoMe–9: A Phase 1/2 Dose Escalation and Expansion Study of BE-101 for the Treatment of Adults with Moderately Severe or Severe Hemophilia B
Session Name: 322. Hemophilia A and B: Clinical and Epidemiological: Poster II
Publication Number: 2593.1
Date: Sunday, December 8, 2024
Time: 6:00 PM – 8:00 PM PT
Session Room: San Diego Convention Center, Halls G-H

Be Bio’s oral presentation on December 7 highlighted the versatility of BCMs in delivering therapeutic biologics for diverse patient populations and diseases. BCMs are designed to produce constant levels of therapeutic proteins in a durable, redosable, and titratable manner, all without the need for preconditioning. The presentation highlighted data from the Company’s two lead candidates, BE-101, a clinical-stage BCM engineered to express hFIX as a potential new treatment for Hemophilia B, and BE-102, a development candidate engineered to express tissue nonspecific alkaline phosphatase (ALP) as a potential treatment option for hypophosphatasia (HPP). The presentation also included data from a BCM prototype engineered to express an anti-CD3:CD19 scFv bispecific T cell engager, which demonstrated a significant reduction in tumor burden in a patient-derived xenograft model of acute lymphoblastic leukemia.

“These data reinforce the capabilities of our versatile B cell engineering platform to develop novel BCMs that express therapeutically relevant proteins,” said Rick Morgan, Ph.D., Chief Scientific Officer, Be Biopharma. “Our BCM platform offers transformative potential to improve the delivery of therapeutic biologics across a wide spectrum of genetic diseases, cancers and other therapeutic areas.”

About Engineered B Cell Medicines – A New Class of Cellular Medicines

The B cell is a powerful cell that produces thousands of proteins per cell per second at constant levels, over decades. Precision genome editing can now be used to engineer B Cells that produce therapeutic proteins of interest, driving a new class of cellular medicines – Engineered B Cell Medicines (BCMs) – with the potential to be durable, allogeneic, redosable, titratable and administered without pre-conditioning. The promise of BCMs could transform therapeutic biologics with broad application — across diverse protein classes, patient populations and therapeutic areas.

About BE-101

BE-101 is a first-in-class engineered B Cell Medicine (BCM) designed to treat Hemophilia B by inserting the human Factor IX (FIX) gene into primary human B cells, enabling continuous expression of active FIX. BE-101 offers the potential for sustained therapeutic FIX activity levels with a single infusion, with the flexibility to be titrated and/or re-dosed, and without the need for preconditioning. By maintaining sustained and constant therapeutic FIX activity levels while reducing dosing frequency required by current FIX replacement regimens, BE-101 could alleviate the considerable infusion burden faced by people with Hemophilia B while potentially lowering annualized bleeding rates and FIX usage. The US FDA cleared the BE-101 IND in May of 2024, and has granted the program Fast Track and Orphan Designations. The Phase 1/2 BeCoMe-9 Trial is open for enrollment and further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT06611436.

About Be Biopharma

Be Biopharma (“Be Bio”) is clinical-stage company pioneering Engineered B Cell Medicines (BCMs) to dramatically improve the lives of patients who are living with Hemophilia B, other genetic diseases, cancer, and other serious conditions. With eyes locked on the patient, Be Bio’s team of purpose-driven scientists, technologists, manufacturing experts and business builders collaborates to create a bold new class of cell therapies. Be Bio was founded in October 2020, Be Bio is backed by ARCH Venture Partners, Atlas Venture, RA Capital Management, Alta Partners, Longwood Fund, Bristol Myers Squibb, Takeda Ventures, Seattle Children’s Research Institute and others. For more information, please visit us at Be.Bio and our LinkedIn page.

Investor Contact:
ir@be.bio

Media Contact:
media@be.bio