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Zura Bio Reports Second Quarter 2025 Financial Results and Recent Corporate Updates
Zura Bio Reports Second Quarter 2025 Financial Results and Recent Corporate Updates

Business Wire

time5 days ago

  • Business
  • Business Wire

Zura Bio Reports Second Quarter 2025 Financial Results and Recent Corporate Updates

HENDERSON, Nev.--(BUSINESS WIRE)-- Zura Bio Limited (Nasdaq: ZURA) ('Zura Bio' or the 'Company'), a clinical-stage, multi-asset immunology company dedicated to developing novel dual-pathway antibodies for autoimmune and inflammatory diseases with unmet needs, today reported financial results for the second quarter ended June 30, 2025, and provided recent corporate updates. 'The second quarter of 2025 marked continued progress across our clinical programs and organizational goals,' said Robert Lisicki, Chief Executive Officer of Zura Bio. 'We advanced our Phase 2 clinical study in systemic sclerosis and initiated a second Phase 2 clinical study in hidradenitis suppurativa. We also welcomed a new Chief Financial Officer as well as a new member of our board of directors, who bring valuable experiences and perspectives. As we look ahead, we remain focused on executing our strategy with discipline and care.' PIPELINE HIGHLIGHTS AND UPCOMING ANTICIPATED MILESTONES Tibulizumab Hidradenitis suppurativa In the second quarter of 2025, Zura Bio initiated TibuSHIELD, a global Phase 2 clinical study evaluating tibulizumab in adults with moderate to severe HS. A topline data readout is anticipated in the third quarter of 2026. Systemic sclerosis The Company also continued to advance TibuSURE, a global Phase 2 clinical study evaluating tibulizumab in adults with SSc. A topline data readout is anticipated in the fourth quarter of 2026. Crebankitug Zura Bio continues to conduct preclinical and translational research on crebankitug to explore its potential in immune-mediated diseases where dual inhibition of interleukin-7 (IL-7) and thymic stromal lymphopoietin (TSLP) may offer therapeutic benefit. The Company is collaborating with academic researchers to guide future development decisions. Torudokimab Zura Bio is evaluating the potential role of torudokimab in inflammatory and respiratory diseases. The Company continues to monitor external clinical data from ongoing IL-33/ST2-targeted programs in asthma and chronic obstructive pulmonary disease, including Phase 2b and Phase 3 trials. An additional IL-33/ST2 data readout is expected in 2026. These findings may help inform future development plans for torudokimab. CORPORATE HIGHLIGHTS In May 2025, Dan Becker, M.D., Ph.D. joined the Board of Directors, bringing a strong background in immunology and biotechnology. In July 2025, Eric Hyllengren was appointed as Chief Financial Officer. With more than 20 years of experience in financial leadership within the life sciences sector, Mr. Hyllengren will help guide the Company's financial and operational planning. SECOND QUARTER 2025 FINANCIAL RESULTS Cash Position As of June 30, 2025, Zura Bio had cash and cash equivalents of $154.5 million. The Company anticipates that its existing cash and cash equivalents should be sufficient to support operations as currently planned through 2027. Research and Development (R&D) Expenses R&D expenses were $8.7 million for the second quarter of 2025, compared to $5.5 million for the same period in 2024. The increase of $3.2 million was primarily related to our continued advancement of our Phase 2 clinical studies evaluating tibulizumab in SSc and HS. Specifically, we incurred a $3.3 million increase in costs related to our SSc and HS clinical studies driven by an increase in contract research organization (CRO) expenses. These increases were partially offset by a $1.3 million reduction in manufacturing costs for our product candidates. R&D compensation costs increased by $0.7 million, reflecting additional headcount to support the growing development organization. General and Administrative (G&A) Expenses G&A expenses were $9.4 million for the second quarter of 2025, compared to $6.2 million for the same period in 2024. The $3.2 million year-over-year increase was primarily driven by a $2.0 million increase in compensation costs to support the expansion of administrative functions and a $1.2 million increase in external spend related to organizational growth as we continue to advance our clinical development programs. Net Loss Net loss for the second quarter of 2025 was $16.0 million, or $0.17 per share, compared to $10.3 million, or $0.17 per share, for the same period in 2024. ABOUT ZURA BIO Zura Bio is a clinical-stage, multi-asset immunology company dedicated to developing novel dual-pathway antibodies for autoimmune and inflammatory diseases with unmet needs. The Company's pipeline includes dual-pathway product candidates designed to target key mechanisms of immune system imbalance, with the goal of improving efficacy, safety, and dosing convenience for patients. Zura Bio's lead product candidate, tibulizumab (ZB-106), is currently being evaluated in two separate Phase 2 clinical studies in adults, including TibuSURE for systemic sclerosis and TibuSHIELD for hidradenitis suppurativa. Additional product candidates, crebankitug (ZB-168) and torudokimab (ZB-880), have completed Phase 1/1b studies and are being evaluated for their potential across a range of autoimmune and inflammatory conditions. For more information, please visit FORWARD-LOOKING STATEMENTS This communication includes 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. Words such as 'expect,' 'estimate,' 'project,' 'budget,' 'forecast,' 'anticipate,' 'intend,' 'plan,' 'may,' 'will,' 'could,' 'should,' 'believe,' 'predict,' 'potential,' 'continue,' 'strategy,' 'future,' 'opportunity,' 'would,' 'seem,' 'seek,' 'outlook,' 'goal,' 'mission,' and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties that could cause the actual results to differ materially from the expected results. These statements are based on various assumptions, whether or not identified in this communication. These forward-looking statements in this release include, but are not limited to, statements regarding: Zura Bio's forecasts, including with respect to its cash resources; Zura Bio's expectations regarding funding, operating and working capital expenditures, business strategies and objectives; and expectations with respect to Zura Bio's development program, including its product candidates and the potential clinical benefits thereof, data readouts, regulatory matters, clinical studies and the design and timing thereof. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events are difficult or impossible to predict and could differ materially from those expressed or implied in such forward-looking statements, as a result of these risks and uncertainties, which include, but are not limited to: Zura Bio's expectations regarding its product candidates and their related benefits, and Zura Bio's beliefs regarding competing product candidates and products both in development and approved, may not be achieved; Zura Bio's vision and strategy may not be successful; the timing of key events and initiation of Zura Bio's studies, regulatory matters and release of clinical data may take longer than anticipated or may not be achieved at all; the potential general acceptability and maintenance of Zura Bio's product candidates by regulatory authorities, payors, physicians, and patients may not be achieved; Zura Bio's ability to attract and retain key personnel; Zura Bio's expectations with respect to its future operating expenses, capital requirements and needs for additional financing may not be achieved; Zura Bio has not completed any clinical trials, and has no products approved for commercial sale; Zura Bio has incurred significant losses since inception, and expects to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future; Zura Bio requires substantial additional capital to finance its operations, and if it is unable to raise such capital when needed or on acceptable terms, Zura Bio may be forced to delay, reduce, and/or eliminate one or more of its development programs or future commercialization efforts; Zura Bio may be unable to renew existing contracts or enter into new contracts; Zura Bio relies on third-party contract development manufacturing organizations for the manufacture of clinical materials; Zura Bio relies on contract research organizations, clinical trial sites, and other third parties to conduct its preclinical studies and clinical studies; Zura Bio may be unable to obtain regulatory approval for its product candidates, and there may be related restrictions or limitations of any approved products; Zura Bio may be unable to successfully respond to general economic and geopolitical conditions; Zura Bio may be unable to effectively manage growth; Zura Bio faces competitive pressures from other companies worldwide; Zura Bio may be unable to adequately protect its intellectual property rights; and other factors set forth in documents filed, or to be filed by Zura Bio, with the Securities and Exchange Commission (SEC), including the risks and uncertainties described in the 'Risk Factors' section of Zura Bio's Annual Report on Form 10-K for the year ended December 31, 2024, as supplemented by Zura Bio's Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2025 and June 30, 2025, and other filings with the SEC. These risks and uncertainties may be amplified by health epidemics or other unanticipated global disruption events, including the conflict between Russia and Ukraine and the Israel-Hamas war and sanctions related thereto, international trade policies, including tariffs, inflation, increased interest rates, uncertain global credit and capital markets and disruptions in banking systems, and changes in regulations, which may continue to cause economic uncertainty. Zura Bio cautions that the foregoing list of factors is not exclusive or exhaustive and not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Zura Bio gives no assurance that it will achieve its expectations. Zura Bio does not undertake or accept any obligation to update any forward-looking statements, except as required by law. ZURA BIO LIMITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) (In thousands, except share and per share data) For the Three Months Ended For the Six Months Ended June 30, June 30, 2025 2024 2025 2024 Operating expenses: Research and development $ 8,704 $ 5,539 $ 19,178 $ 9,132 General and administrative 9,358 6,220 18,138 11,006 Total operating expenses 18,062 11,759 37,316 20,138 Loss from operations (18,062 ) (11,759 ) (37,316 ) (20,138 ) Other (income)/expense, net: Interest income (1,717 ) (2,196 ) (3,534 ) (3,411 ) Change in fair value of private placement warrants — 768 — 1,374 Other income, net (352 ) (2 ) (347 ) (25 ) Total other income, net (2,069 ) (1,430 ) (3,881 ) (2,062 ) Loss before income taxes (15,993 ) $ (10,329 ) (33,435 ) (18,076 ) Income tax benefit — — — — Net loss (15,993 ) (10,329 ) (33,435 ) (18,076 ) Accretion of redeemable noncontrolling interest to redemption value — (2,337 ) — (2,337 ) Adjustment of redeemable noncontrolling interest from redemption value to carrying value — — — 7,017 Net loss attributable to Class A Ordinary Shareholders of Zura $ (15,993 ) $ (12,666 ) $ (33,435 ) $ (13,396 ) Net loss per share attributable to Class A Ordinary Shareholders of Zura, basic and diluted $ (0.17 ) $ (0.17 ) $ (0.36 ) $ (0.22 ) Weighted-average Class A Ordinary Shares used in computing net loss per share attributable to Class A Ordinary Shareholders of Zura, basic and diluted 94,289,954 74,947,369 93,630,719 60,930,956 Expand

Israeli scientists identify protein that could prevent painful food allergy disease
Israeli scientists identify protein that could prevent painful food allergy disease

Time of India

time12-08-2025

  • Health
  • Time of India

Israeli scientists identify protein that could prevent painful food allergy disease

Tel Aviv: Israeli scientists have discovered that blocking a specific protein may stop a painful food allergy-related disease before it starts. The finding, Tel Aviv University announced on Monday, could lead to targeted treatments for Eosinophilic Esophagitis (EoE) that spare patients from severe symptoms and restrictive diets. The disease - an inflammation of the oesophagus - affects an estimated 1 in 2,500 individuals. Flare-ups are caused by an abnormal allergic reaction to certain foods or environmental triggers that lead to inflammation and tissue changes in the oesophagus. Left untreated, scarring narrows the width of the oesophagus, making it difficult and painful to swallow food. In extreme cases, the oesophagus can even tear. There is no cure, and it is managed primarily by diet and medicine. But scientists at Tel Aviv University identified a protein whose neutralisation may prevent the onset of EoE. The study, conducted at the university's Gray Faculty of Medical and Health Sciences, focused on the protein thymic stromal lymphopoietin (TSLP). Researchers found that blocking it in experimental models either prevented the disease entirely or dramatically reduced its severity. Their findings were published in Allergy, a peer-reviewed journal. "Eosinophilic Esophagitis, or EoE, is a type of food allergy . It is a chronic inflammation of the esophagus caused by an abnormal immune response to food -- mainly milk, eggs, wheat, nuts, fish, and more," said Prof. Ariel Munitz, who led the study alongside doctoral student Anish Dsilva. "The disease is characterized by an accumulation of eosinophils, a type of white blood cell that is not typically present in a healthy esophagus." Symptoms include difficulty swallowing, chest and abdominal pain, food getting stuck in the throat, and in children, growth delays. EoE is often linked to asthma and atopic dermatitis. Current treatments involve strict elimination diets or amino acid-based formulas, with limited effectiveness. "Over the past decade, there has been a concerning rise in the prevalence of EoE worldwide, including in Israel," Munitz said. "We are studying the disease in depth to understand the involvement of various immune system components in its progression. These components may serve as targets for future treatment for this disease, and for other allergic disorders as well." A previous study from Munitz's lab developed an experimental model replicating EoE symptoms in humans. Building on that work, the team focused on epithelial cells -- the protective outer layer lining the esophagus. "In allergic conditions, epithelial cells release various substances in response to encountering an allergen, and these substances trigger the chain of events that initiate the inflammatory process we experience as an allergy attack," Munitz explained. The researchers observed that epithelial cells in their EoE model secreted high levels of two proteins: IL-33 and TSLP. They also found immune cells in esophageal tissue with receptors for both proteins, suggesting that each could play a role in disease development. To pinpoint which protein was more influential, the team used genetic engineering to create models lacking one protein at a time. The results were striking: removing IL-33 had little effect, but removing TSLP led to marked improvement -- in many cases, the disease did not develop at all. Antibody treatments designed to neutralize TSLP produced similar results, with significant reductions in symptoms. Further genetic and bioinformatic analysis confirmed that TSLP acts as a "key regulator" of the disease process. "These findings suggest that TSLP is not just involved but is central to driving EoE," Munitz said. "We know that pharmaceutical companies are currently developing a variety of antibodies targeting disease-causing proteins, under the broad category of biological therapies, including antibodies against TSLP. We believe these antibodies could serve as an effective treatment for EoE." The research was carried out in collaboration with Dr. Chen Varol of Ichilov Hospital, Prof. Marc Rothenberg of Cincinnati Children's Hospital, and the AstraZeneca pharmaceutical company. If future clinical trials confirm the findings, neutralizing TSLP could offer a targeted, less burdensome treatment for patients, potentially preventing years of discomfort and dietary restrictions. "EoE causes significant suffering and is becoming increasingly prevalent worldwide," Munitz said. "Our study offers real hope for a therapy that addresses the disease at its source."

Teva and Biolojic Design Initiate IND-enabling Studies of BD9, a Multibody Designed to Explore the Treatment of Atopic Dermatitis and Asthma
Teva and Biolojic Design Initiate IND-enabling Studies of BD9, a Multibody Designed to Explore the Treatment of Atopic Dermatitis and Asthma

Yahoo

time27-05-2025

  • Business
  • Yahoo

Teva and Biolojic Design Initiate IND-enabling Studies of BD9, a Multibody Designed to Explore the Treatment of Atopic Dermatitis and Asthma

REHOVOT, Israel and WASHINGTON and TEL AVIV, Israel, May 27, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) and Biolojic Design Ltd. ('Biolojic'), a biotechnology company using computational biology and artificial intelligence to design next generation, multifunctional antibodies known as multibodies, announced today that Teva initiated IND-enabling studies with BD9, a dual-specific multibody targeting both TSLP (Thymic stromal lymphopoietin) and IL-13. Teva has an exclusive license to develop BD9 for the treatment of TH2-driven inflammatory diseases such as atopic dermatitis and asthma. Teva's development of BD9 demonstrates the company's commitment to applying cutting-edge science to address unmet medical needs. By simultaneously blocking two key drivers of TH2-driven inflammation, BD9 has the potential to improve outcomes for patients with conditions such as atopic dermatitis and asthma, where current treatments fall short. The initiation of IND-enabling studies marks a critical milestone in translating this scientific innovation into a potential therapeutic option, paving the way for clinical trials and ultimately bringing hope to underserved patient populations. This progress exemplifies Teva's focus on advancing transformative therapies that expand access and impact through innovation. 'We're excited to have successfully achieved another milestone in our partnership with Teva,' said Yanay Ofran, PhD, CEO and founder of Biolojic Design. 'Biolojic's next generation antibody platform has now produced four antibodies that are in, or nearing, the clinic. From the clinical data we have recently seen, it is already clear that our precision antibodies have distinct advantages over traditional antibodies, extracting better efficacy and safety from complex biological targets.' Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva said, 'With the initiation of IND-enabling studies we take a vital step toward delivering innovative treatments to patients who need them most. This pre-clinical progress underscores Teva's commitment to accelerating innovation and to improving health outcomes and access to underserved patient populations.' Under the terms of their agreement, Teva is developing BD9 worldwide. In exchange, Biolojic is eligible to receive milestone payments based on the achievement of certain pre-clinical, clinical, regulatory, and commercial milestones, including the initiation of IND-enabling studies. About Biolojic DesignBiolojic Design is pioneering the use of precision antibodies, including multibodies, a next generation antibody technology in which each arm of a conventional IgG (immunoglobulin G) antibody can bind to multiple targets, enabling a multibody to address complex disease biology. Biolojic designs its multibodies using computational biology and AI, and its platform generated the first AI-designed antibody to enter the clinic, which is now in phase 2 clinical trials. The company's pipeline focuses on autoimmune diseases and oncology, unlocking validated pathways that address large unmet needs. It is progressing its own pipeline, and has partnerships with several leading biopharmaceutical companies to enhance its ability to bring important new medicines to patients. For more information about Biolojic Design and its science and pipeline, please visit or follow us on LinkedIn. About TevaTeva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global biopharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company's global network of capabilities enables its 37,000 employees across 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. We are dedicated to addressing patients' needs, now and in the future. Moving forward together with science that treats, inspired by the people we serve. To learn more about how Teva is all in for better health, visit Teva Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management's current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as 'should,' 'expect,' 'anticipate,' 'estimate,' 'target,' 'may,' 'project,' 'guidance,' 'intend,' 'plan,' 'believe' and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our partnership with Biolojic; our ability to successfully develop BD9, a Dual-Specific Antibody Designed to Explore the Treatment of TH2-driven inflammatory diseases; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, to sustain and focus our portfolio of generic medicines; and to execute on our organizational transformation and to achieve expected cost savings and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the section captioned 'Risk Factors' and 'Forward-Looking Statements.' Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. Teva Media Inquiries TevaCommunicationsNorthAmerica@ Teva Investor Relations Inquiries TevaIR@ while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data

Teva and Biolojic Design Initiate IND-enabling Studies of BD9, a Multibody Designed to Explore the Treatment of Atopic Dermatitis and Asthma
Teva and Biolojic Design Initiate IND-enabling Studies of BD9, a Multibody Designed to Explore the Treatment of Atopic Dermatitis and Asthma

Yahoo

time27-05-2025

  • Business
  • Yahoo

Teva and Biolojic Design Initiate IND-enabling Studies of BD9, a Multibody Designed to Explore the Treatment of Atopic Dermatitis and Asthma

REHOVOT, Israel and WASHINGTON and TEL AVIV, Israel, May 27, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) and Biolojic Design Ltd. ('Biolojic'), a biotechnology company using computational biology and artificial intelligence to design next generation, multifunctional antibodies known as multibodies, announced today that Teva initiated IND-enabling studies with BD9, a dual-specific multibody targeting both TSLP (Thymic stromal lymphopoietin) and IL-13. Teva has an exclusive license to develop BD9 for the treatment of TH2-driven inflammatory diseases such as atopic dermatitis and asthma. Teva's development of BD9 demonstrates the company's commitment to applying cutting-edge science to address unmet medical needs. By simultaneously blocking two key drivers of TH2-driven inflammation, BD9 has the potential to improve outcomes for patients with conditions such as atopic dermatitis and asthma, where current treatments fall short. The initiation of IND-enabling studies marks a critical milestone in translating this scientific innovation into a potential therapeutic option, paving the way for clinical trials and ultimately bringing hope to underserved patient populations. This progress exemplifies Teva's focus on advancing transformative therapies that expand access and impact through innovation. 'We're excited to have successfully achieved another milestone in our partnership with Teva,' said Yanay Ofran, PhD, CEO and founder of Biolojic Design. 'Biolojic's next generation antibody platform has now produced four antibodies that are in, or nearing, the clinic. From the clinical data we have recently seen, it is already clear that our precision antibodies have distinct advantages over traditional antibodies, extracting better efficacy and safety from complex biological targets.' Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva said, 'With the initiation of IND-enabling studies we take a vital step toward delivering innovative treatments to patients who need them most. This pre-clinical progress underscores Teva's commitment to accelerating innovation and to improving health outcomes and access to underserved patient populations.' Under the terms of their agreement, Teva is developing BD9 worldwide. In exchange, Biolojic is eligible to receive milestone payments based on the achievement of certain pre-clinical, clinical, regulatory, and commercial milestones, including the initiation of IND-enabling studies. About Biolojic DesignBiolojic Design is pioneering the use of precision antibodies, including multibodies, a next generation antibody technology in which each arm of a conventional IgG (immunoglobulin G) antibody can bind to multiple targets, enabling a multibody to address complex disease biology. Biolojic designs its multibodies using computational biology and AI, and its platform generated the first AI-designed antibody to enter the clinic, which is now in phase 2 clinical trials. The company's pipeline focuses on autoimmune diseases and oncology, unlocking validated pathways that address large unmet needs. It is progressing its own pipeline, and has partnerships with several leading biopharmaceutical companies to enhance its ability to bring important new medicines to patients. For more information about Biolojic Design and its science and pipeline, please visit or follow us on LinkedIn. About TevaTeva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global biopharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company's global network of capabilities enables its 37,000 employees across 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. We are dedicated to addressing patients' needs, now and in the future. Moving forward together with science that treats, inspired by the people we serve. To learn more about how Teva is all in for better health, visit Teva Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management's current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as 'should,' 'expect,' 'anticipate,' 'estimate,' 'target,' 'may,' 'project,' 'guidance,' 'intend,' 'plan,' 'believe' and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our partnership with Biolojic; our ability to successfully develop BD9, a Dual-Specific Antibody Designed to Explore the Treatment of TH2-driven inflammatory diseases; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, to sustain and focus our portfolio of generic medicines; and to execute on our organizational transformation and to achieve expected cost savings and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the section captioned 'Risk Factors' and 'Forward-Looking Statements.' Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. Teva Media Inquiries TevaCommunicationsNorthAmerica@ Teva Investor Relations Inquiries TevaIR@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Teva and Biolojic Design Initiate IND-enabling Studies of BD9, a Multibody Designed to Explore the Treatment of Atopic Dermatitis and Asthma
Teva and Biolojic Design Initiate IND-enabling Studies of BD9, a Multibody Designed to Explore the Treatment of Atopic Dermatitis and Asthma

Yahoo

time27-05-2025

  • Business
  • Yahoo

Teva and Biolojic Design Initiate IND-enabling Studies of BD9, a Multibody Designed to Explore the Treatment of Atopic Dermatitis and Asthma

REHOVOT, Israel and WASHINGTON and TEL AVIV, Israel, May 27, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) and Biolojic Design Ltd. ('Biolojic'), a biotechnology company using computational biology and artificial intelligence to design next generation, multifunctional antibodies known as multibodies, announced today that Teva initiated IND-enabling studies with BD9, a dual-specific multibody targeting both TSLP (Thymic stromal lymphopoietin) and IL-13. Teva has an exclusive license to develop BD9 for the treatment of TH2-driven inflammatory diseases such as atopic dermatitis and asthma. Teva's development of BD9 demonstrates the company's commitment to applying cutting-edge science to address unmet medical needs. By simultaneously blocking two key drivers of TH2-driven inflammation, BD9 has the potential to improve outcomes for patients with conditions such as atopic dermatitis and asthma, where current treatments fall short. The initiation of IND-enabling studies marks a critical milestone in translating this scientific innovation into a potential therapeutic option, paving the way for clinical trials and ultimately bringing hope to underserved patient populations. This progress exemplifies Teva's focus on advancing transformative therapies that expand access and impact through innovation. 'We're excited to have successfully achieved another milestone in our partnership with Teva,' said Yanay Ofran, PhD, CEO and founder of Biolojic Design. 'Biolojic's next generation antibody platform has now produced four antibodies that are in, or nearing, the clinic. From the clinical data we have recently seen, it is already clear that our precision antibodies have distinct advantages over traditional antibodies, extracting better efficacy and safety from complex biological targets.' Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva said, 'With the initiation of IND-enabling studies we take a vital step toward delivering innovative treatments to patients who need them most. This pre-clinical progress underscores Teva's commitment to accelerating innovation and to improving health outcomes and access to underserved patient populations.' Under the terms of their agreement, Teva is developing BD9 worldwide. In exchange, Biolojic is eligible to receive milestone payments based on the achievement of certain pre-clinical, clinical, regulatory, and commercial milestones, including the initiation of IND-enabling studies. About Biolojic DesignBiolojic Design is pioneering the use of precision antibodies, including multibodies, a next generation antibody technology in which each arm of a conventional IgG (immunoglobulin G) antibody can bind to multiple targets, enabling a multibody to address complex disease biology. Biolojic designs its multibodies using computational biology and AI, and its platform generated the first AI-designed antibody to enter the clinic, which is now in phase 2 clinical trials. The company's pipeline focuses on autoimmune diseases and oncology, unlocking validated pathways that address large unmet needs. It is progressing its own pipeline, and has partnerships with several leading biopharmaceutical companies to enhance its ability to bring important new medicines to patients. For more information about Biolojic Design and its science and pipeline, please visit or follow us on LinkedIn. About TevaTeva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global biopharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company's global network of capabilities enables its 37,000 employees across 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. We are dedicated to addressing patients' needs, now and in the future. Moving forward together with science that treats, inspired by the people we serve. To learn more about how Teva is all in for better health, visit Teva Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management's current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as 'should,' 'expect,' 'anticipate,' 'estimate,' 'target,' 'may,' 'project,' 'guidance,' 'intend,' 'plan,' 'believe' and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our partnership with Biolojic; our ability to successfully develop BD9, a Dual-Specific Antibody Designed to Explore the Treatment of TH2-driven inflammatory diseases; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, to sustain and focus our portfolio of generic medicines; and to execute on our organizational transformation and to achieve expected cost savings and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the section captioned 'Risk Factors' and 'Forward-Looking Statements.' Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. Teva Media Inquiries TevaCommunicationsNorthAmerica@ Teva Investor Relations Inquiries TevaIR@

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