Merck’s Corporate Venture M Ventures Arm Backs Nucleai to Advance Its First-in-class Spatial AI Biomarker in Active Clinical Enrollment

The Extension Funds Nucleai to Advance Its First-in-Class Spatial AI Biomarker in Active Clinical Enrollment

Investment Expands Deployments of AI-Powered Spatial Biomarker Technology, Strengthening Companion Diagnostics for ADCs, Bi-specifics, and Immunotherapies

M Ventures is the corporate strategic venture arm of Merck KGaA, Darmstadt, Germany

CHICAGO–(BUSINESS WIRE)–Nucleai, a spatial AI biomarker company that deciphers cellular conversations and maps cellular interactions within tissue samples to predict therapeutic outcomes, has secured a $14 million investment led by M Ventures, the corporate venture capital arm of Merck KGaA, Darmstadt, Germany, and supported by existing investors, bringing the total funding to $60 million. The investment enables Nucleai to further deploy its AI algorithms for the prospective enrollment of patients in clinical trials – a first in the field and a significant advancement in personalized solutions tailored to the distinct needs of patients.

The funding exemplifies Nucleai’s growing momentum in the life sciences industry, evidenced by collaborations with over 60 percent of the top 20 biopharma companies, venture backing from renowned investors like Section 32 and Sanofi Ventures, and now with M Ventures. The funding will accelerate the deployment of Nucleai’s spatial analysis technology that transforms a static biopsy slide into a dynamic AI-guided action plan, empowering pathologists with the intelligence to anticipate and navigate complex diseases, like cancer, with unmatched precision.

By integrating AI algorithms for prospective patient enrollment in clinical trials, Nucleai is spearheading a first-in-field approach to personalized medicine. This process is crucial for enhancing the accuracy of treatment targeting and activation within the body, particularly for advanced therapeutics such as antibody-drug conjugates (ADCs) and bi-specifics. Nucleai’s platform tailors therapy strategies to the intricate cellular landscape of each patient, optimizing clinical trial participant selection. This personalized approach not only improves the likelihood of successful clinical outcomes but also significantly contributes to the speed and efficiency of bringing new therapies to market.

Leveraging AI and machine learning (ML), Nucleai analyzes pathology images and spatial data at the cellular and tissue levels. The proprietary technology extracts detailed patterns and features from medical images, offering profound insights into the tumor microenvironment, cellular morphology, and spatial relationships between different cell types. These capabilities advance drug development, refine biomarker discovery, and improve the precision of therapeutic targeting, ultimately leading to more effective and personalized treatment options for patients.

Avi Veidman, CEO and Co-Founder of Nucleai, said, “M Ventures’ investment boosts our ability to scale and deploy our spatial AI technology for patient enrollment in clinical trials and supports our work in the rapidly emerging areas of immunotherapies, antibody-drug conjugates, and bi-specifics. Our vision is that every next-generation therapeutic is accompanied with an AI-enabled companion diagnostic, ensuring that each patient’s treatment pathway is informed and efficacious. This funding positions us to scale spatial AI, not just to intercept but anticipate the complex behavior of diseases.”

Noga Yerushalmi, Investment Director at M Ventures, who is appointed to the board of Nucleai, stated, “Nucleai’s technology stands out by being the first spatial AI tool used by pathologists for clinical trial patient selection that is directly connected to a drug development program, setting them apart from other companies. Nucleai’s biology-driven mindset and their multimodal approach, which combines traditional pathology data with spatial biology data, allows for more accurate predictions of treatment responses, aligning perfectly with our commitment to optimise speed of new therapies to reach patients.”

By moving beyond traditional pathology’s analog analysis, Nucleai leverages AI to create dynamic, digital maps from biopsy samples, uncovering the complex interactions at play within tissue. This innovation marks a shift in disease diagnosis and treatment, offering an in-depth contextual view that underpins the development of novel therapeutics.

About Nucleai

Nucleai is the leading AI-powered spatial biomarker company, driving innovation at the intersection of technology and healthcare. Leveraging military intelligence-grade geospatial analytical methods, it intercepts, interprets, and analyzes complex cellular conversations and spatially oriented interactions within tissue samples, translating them into actionable insights. Nucleai’s platform empowers pathologists and researchers with an AI-powered data-rich action plan, paving the way for more informed decisions in the development of bi-specifics, antibody-drug conjugates (ADCs), and immunotherapy. Nucleai’s investors include Section 32, Sanofi, Vertex Ventures, M Ventures, and Debiopharm Innovation Fund. It is headquartered in Israel and Chicago. For more information, please visit

About M Ventures

M Ventures is the strategic, corporate venture capital arm of Merck KGaA, Darmstadt, Germany. From its headquarters in the Netherlands and offices in Germany, USA and Israel, M Ventures invests globally in transformational ideas driven by innovative entrepreneurs. Taking an active role in its portfolio companies, M Ventures teams up with management teams and co-investors to translate scientific discoveries into commercial success. M Ventures focuses on identifying and financing novel solutions to some of the most difficult challenges, through company creation and equity investments in fields that will impact the vitality and sustainability of Merck KGaA, Darmstadt, Germany’s current and future businesses.


Consort Partners for Nucleai

Laverock Therapeutics announces appointment of Ali Elsley as Finance Director and expansion of team

STEVENAGE, United Kingdom, March 26, 2024 (GLOBE NEWSWIRE) — Laverock Therapeutics, a gene-silencing company with a uniquely powerful technology for the development of programmable advanced therapies to tackle major diseases, today announces the appointment of Ali Elsley as Finance Director.

Ali has extensive experience in the biotechnology and pharma sector working with both private and public companies. She joins from Acacia Pharma Group plc, an early commercial-stage listed pharma company, where she was Group Financial Controller and Company Secretary and focused on equity fundraising, M&A activity and all aspects of financial operations. Prior to this, she spent 10 years as an auditor with PwC LLP in Cambridge, with a focus on early-stage biotech and pharma companies, together with advisory IPO work. She is a fellow of the Institute of Chartered Accountants in England and Wales and holds a degree in Archaeology and Anthropology from the University of Cambridge.

In addition to Ali’s appointment, Laverock has significantly grown its team to 24 people, representing growth of 50% over the past year, and expanded its R&D facilities in the Stevenage Bioscience Catalyst as it continues to build its capabilities following its £13.5m expanded seed round announced in September last year, the second highest seed investment by a UK company in 2023.

David Venables, CEO of Laverock, said: “Ali has an exceptional track record working with innovative biotechnology and pharma companies. I very much look forward to working closely with her and the rest of our fast-growing team as we continue to apply our uniquely powerful gene-silencing technology to the development of a new generation of programmable advanced therapies to tackle major diseases.”

Ali Elsley, FD of Laverock, said: “Laverock’s technology has the potential to create a step-change in advanced therapies and I have been hugely impressed with the pace of progress since joining the company. The management team and Board are exceptionally strong, and I believe we have a very solid foundation from which to deliver on the promise.”

For further information please contact:

Laverock Therapeutics:


Media Enquiries :

Charles Consultants
Sue Charles – +44 (0)7968 726585
Chris Gardner – +44 (0)7956 031077

About Laverock Therapeutics

Laverock Therapeutics is a gene-silencing company with a uniquely powerful technology which harnesses the cell’s natural gene regulatory mechanisms to develop a new generation of programmable advanced therapies to tackle major diseases. Laverock’s truly innovative technology re-directs naturally-occurring micro RNAs (miRNAs) to conditionally silence genes in a way which is programmable, tunable, stable and specific. This opens a path to more effective, safer and accessible advanced therapies. Laverock is applying its technology through its own pipeline – targeting regenerative medicine and oncology – and through partnerships.

Laverock has a highly experienced leadership team with proven track records in biotechnology, pharma and academia, and an exceptionally strong Board. Laverock completed a £13.5m seed round in September 2023. Its high-calibre investors include Calculus Capital, Eli Lilly and Company, Mercia Ventures, Maven Capital Partners, Eos, UK Innovation & Science Seed Fund and Tekfen Ventures.

For more information, please visit and follow us on LinkedIn.

Protembis Announces Completion of € 30 Million Series B Financing Round and the Addition of Keith D Dawkins MD to the Board of Directors

AACHEN, Germany–(BUSINESS WIRE)–#CerebralProtection–Protembis GmbH (Protembis), a privately-held emerging cardiovascular medical device company, announced today the completion of a € 30 million Series B financing round to support the enrollment of the PROTEMBO Investigational Device Exemption (IDE) Pivotal Trial (NCT05873816). The funding round was structured in two separate capital increases which have both been completed. It was co-led by a European consortium of VC investors including Sweden-based Segulah Medical Acceleration, Italy-based XGEN Venture, and Germany-based TechVision Fund. Other investors include Coparion, several large family offices, angel investors and a multinational medical device strategic.

“We are delighted to announce the completion of the round and would like to thank our existing investors as well as the new investors for their trust and confidence,” said Karl von Mangoldt and Conrad Rasmus Co-CEOs of Protembis. “It reflects the fact that the field of cerebral embolic protection is buoyant, and that future growth will be driven by younger and lower risk patients who have zero tolerance for brain injury risk when selecting to undergo transcatheter aortic valve replacement.”

Additionally, Protembis is proud to announce the addition of Keith D. Dawkins, MD, to the Board of Directors. Dr Dawkins has more than 35 years’ experience in the cardiovascular environment. With over 20 years as a practicing interventional cardiologist in the UK he has held research roles as a Fulbright Scholar at Stanford University, served as President of the British Cardiovascular Intervention Society, and authored more than 750 academic publications and presentations. Dr Dawkins has been the Chief Medical Officer (CMO) of Shockwave (NASDAQ:SWAV) since 2019, and this was preceded by his role as Global CMO at Boston Scientific where he held senior positions since 2008. He also serves as a member of the boards of Ventric Health LLC and JenaValve Technology Inc., as well as Chairman of InnovHeart s.r.l. Dr Dawkins will contribute his significant expertise to the clinical strategies of Protembis and the pre-commercial programs as the IDE study reaches its conclusion.

“To have such a visionary leader as Dr Dawkins join our Board of Directors is an exciting indication of the opportunities that cerebral embolic protection holds for future transcatheter therapies. We look forward to close collaboration as the field develops and our superiority trial gains momentum,” said Azin Parhizgar, PhD, Chairwoman of the Board of Directors.

“As a long-term believer in the need to protect the brain from all new lesions during transcatheter aortic valve replacement, I am very pleased to join Protembis,” said Dr Dawkins. “The ProtEmbo System and the clinical trial design are both novel and I am confident that they will be highly disruptive to the field of cerebral embolic protection, removing or mitigating many of the current issues that concern the physician community.”

About ProtEmbo® and Protembis

The ProtEmbo® Cerebral Protection System is an intra-aortic filter device that protects the entire brain from embolic material liberated during transcatheter aortic valve replacement (TAVR). It is a low-profile non thrombogenic system that shields all cerebral vessels, delivered through the left radial artery for optimal placement and stability. This is an ideal access site enabling physicians to avoid interference with TAVR equipment typically delivered through the femoral artery.

Protembis is a privately held emerging medical device company that has developed the ProtEmbo® Cerebral Protection System. The company strives to provide a simple and reliable solution to protect patients from brain injury during left-sided heart procedures, improving patient quality of life and reducing overall healthcare costs associated with brain injury during such procedures. The ProtEmbo System is currently undergoing clinical investigations.


Protembis GmbH

Conrad Rasmus & Karl von Mangoldt

+49(0)241 9903 3622

Biocytogen Enters Collaboration with ABL Bio to Develop New Bispecific Antibody-Drug Conjugates

BEIJING–(BUSINESS WIRE)–#ADC–Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (“Biocytogen”, HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, and ABL Bio Inc. (“ABL”, KOSDAQ: 298380), a Korean clinical-stage biotechnology company developing novel therapeutics in oncology and CNS diseases, today announced a collaboration to develop new bispecific antibody-drug conjugates (bsADCs).

Biocytogen’s RenLite® mice platform can produce fully human antibodies with diverse epitopes and high affinity. This platform is notable for its ability to generate antibodies in a common light chain format, offering a distinctive combination of design flexibility, simplified manufacturing processes, and optimal developability for bsADC development. Based on this platform, both companies will be able to discuss expanding their collaboration for various types of ADC development.

Dr. Yuelei Shen, President and CEO of Biocytogen, said, “We are very pleased to collaborate with ABL, a company that possesses advanced platforms for cancer immunotherapy and treatments against CNS diseases. ABL’s consistent success in advancing its pipeline strongly showcases its expertise and capabilities in regulatory, clinical development, and business development activities. BsADC drugs derived from our RenLite® mice platform have shown preferable potency in various tumor models, while also exhibiting good safety profiles. We believe our fully human bsADC platform technology, which features increased tumor selectivity, target synergized internalization, and convenient CMC development, will complement ABL’s capabilities effectively. Together, we aim to expedite the development of innovative bsADC therapies.”

Sang Hoon Lee, CEO of ABL, said, “We are excited to establish this partnership with Biocytogen for bsADCs. This collaboration is one of the stepping stones for getting down to developing bsADCs. We look forward to a productive collaboration, and firmly believe that this partnership will contribute towards creating a distinctive pipeline, ultimately leading to novel therapies that improve the quality of life for patients.”

About Biocytogen

Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice® (RenMabTM/RenLite®/RenNano®/RenTCR-mimicTM) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR-mimic antibody discovery, and has established a sub-brand, RenBiologicsTM, to explore global partnerships for an off-the-shelf library of >400,000 fully human antibody sequences against approximately 1000 targets for worldwide collaboration. As of June 30, 2023, 50 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and 42 target-nominated RenMice® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company’s sub-brand, BioMiceTM, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA (Boston, San Francisco), and Germany (Heidelberg). For more information, please visit

About ABL Bio

ABL Bio Inc. (KOSDAQ: 298380) is a clinical-stage biotechnology company developing antibody therapeutics for immune-oncology and neurodegenerative diseases. With internal R&D and global partnerships, ABL has developed multiple BsAb platforms, such as ‘Grabody-T,’ ‘Grabody-B’ and built an innovative pipeline of multiple clinical and pre-clinical stage drug candidates. In the oncology area, we have developed Grabody-T, a modular 4-1BB engaging platform that has demonstrated superior efficacy and safety. In the neurodegenerative disorder space, we have developed Grabody-B, which is designed to maximize blood-brain barrier (BBB) penetration. Grabody-B is applicable to various CNS targets across a plethora of neurological disorders, potentially providing a breakthrough to address the high unmet medical needs in neurodegeneration. For more information, please visit


Biocytogen Contacts
Antibody assets and platforms:

AriBio Licenses Exclusive Marketing Rights for AR1001 for Alzheimer’s Disease in China for $770 Million USD

SEONGNAM-SI, South Korea–(BUSINESS WIRE)–AriBio Co., Ltd. (AriBio), announces signing of exclusive marketing rights for AR1001, an investigational drug for early Alzheimer’s disease, in China for up to $770 million USD.

The term consists of a non-refundable upfront payment of 120 billion KRW (approximately 90 million USD), with the total deal summing up to 5.59 billion RMB (approximately 770 million USD) inclusive of milestone payments with additional royalties. The upfront payment will be paid starting from mid-2024.

In response to the increasing Alzheimer’s disease population in China, prominent pharmaceutical companies have sought to develop safe and effective oral treatments for Alzheimer’s disease. To date, AriBio has partnered for exclusive marketing rights in South Korea with Samjin Pharmaceutical for 100 billion KRW. And now, the partnership has expanded to China, cumulating to 1.12 trillion KRW (approximately 840 million USD). Considering the market competition for Alzheimer’s drugs in China and the sales strategy, the licensee requested not to be disclosed until an agreed upon time.

The global Phase 3 clinical trial for AR1001 in early Alzheimer’s disease patients (Polaris-AD) is on-going in the United States, United Kingdom, and South Korea. Furthermore, the clinical trial is awaiting regulatory approval in China and the European Union. This study will be conducted across 180 global sites. The first patient enrollment began in the United States in December 2022, and the rest of the regions are actively enrolling.

Matthew (Jai Jun) Choung, CEO and Chairman of AriBio, stated, “This deal demonstrates our unwavering commitment to developing meaningful treatments for Alzheimer’s disease, and our partners will help position AR1001 for success in the major Asian territories. We are building momentum in our AR1001 program, as we continue to discuss with other potential partners in Asian countries, the Middle East, South America, as well as Europe and the United States.”

About AR1001

AR1001 is a PDE5 inhibitor being developed as an investigational oral agent for the treatment of Alzheimer’s disease. Pre-clinical studies have confirmed neuroprotective effects of AR1001 via inhibiting neuron apoptosis and restoring synaptic plasticity. AR1001 has also demonstrated robust reduction of hyperphosphorylated tau proteins in pre-clinical models as well as in a Phase 2 trial.

About AR1001-ADP3-US01

AR1001-ADP3-US01 (NCT05531526) is a Phase 3 double-blind, randomized, placebo-controlled, multi-center trial to evaluate the efficacy and safety of AR1001 over 52 weeks in participants with early Alzheimer’s disease. The study aims to assess the efficacy and safety of AR1001 in slowing the progression of Alzheimer’s disease through various cognitive and functional assessments. The details of the clinical trial are available at

About AriBio

AriBio Co., Ltd. is a biopharmaceutical company based in South Korea with offices in both South Korea and the United States. The company focuses on the development of novel therapies for neurodegenerative diseases. The company continues to expand its partnerships to accelerate the development of meaningful treatment options for neurodegenerative diseases.


Fred Kim

Promising Intracranial Anti-Tumor Activity and Safety Data for Ivonescimab in NSCLC Patients with Brain Metastases Featured at ELCC 2024

Ivonescimab alone or combined with chemotherapy led to intracranial responses among 34% of patients with brain metastases at baseline – 23% achieved a complete response

All patients who did not achieve an intracranial response demonstrated stable disease or non-progression by RANO criteria irrespective of cohort

Median intracranial PFS of 19.3 months observed across combined cohorts of ivonescimab administered as monotherapy or in combination with chemotherapy

No cases of intracranial bleeding were observed in these patients with brain metastases

Detailed safety and anti-tumor activity updates from Phase II trial for ivonescimab plus chemotherapy in multiple NSCLC settings, including 1L squamous NSCLC

MIAMI–(BUSINESS WIRE)–$SMMT–Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced promising data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, that is being presented today at the 2024 European Lung Cancer Congress (ELCC 2024) in Prague, Czech Republic. Two posters featuring updated ivonescimab data will be displayed from 12:00 to 12:45pm Central European Time. The posters will also be made available on our website after the presentation period.

The first poster, “Intracranial Activity of Ivonescimab Alone or in Combination with Platinum Doublet Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases” includes data from patients with asymptomatic brain metastases at baseline. These patients were enrolled in either AK112-202 (NCT04900363), in which ivonescimab is delivered as monotherapy, or AK112-201 (NCT04736823), in which ivonescimab is delivered in combination with platinum doublet chemotherapy, both of which are Phase II clinical trials for patients with advanced or metastatic NSCLC. This analysis consisted of the 35 patients with advanced or metastatic NSCLC who had asymptomatic brain metastases at baseline; 28 patients were treated with ivonescimab plus chemotherapy in AK112-201, and seven patients were treated with monotherapy ivonescimab in AK112-202.

Notably, median intracranial progression-free survival was 19.3 months across all patients analyzed. Patients across both cohorts experienced an intracranial response rate of 34%, and eight patients (23%) experienced a complete response by RANO criteria. All patients who did not achieve a response demonstrated stable disease or non-progression; no patients experienced intracranial disease progression at the time of the initial follow-up scan. No cases of intracranial bleeding complications were observed in these patients.

“We are pleased to see ivonescimab’s favorable intracranial response rates and median intracranial progression-free survival as well as promising anti-tumor activity and safety profile in the subgroup of patients with brain metastases from NSCLC,” said Dr. H. Jack West, Vice President of Clinical Development at Summit. “We are grateful for the patients and clinical investigators supporting these trials, and our ongoing collaboration with our partners at Akeso.”

The second poster titled, “Phase 2 Results of Ivonescimab a Novel PD-1/VEGF Bispecific in Combination with Chemotherapy for First Line Treatment of Patients with Advanced / Metastatic Non-Small Cell Lung Cancer” includes updated data from the Phase II trial AK112-201 centered around the cohort of patients in which ivonescimab is combined with chemotherapy for first-line treatment of squamous and non-squamous advanced or metastatic NSCLC in patients without actionable genomic alterations (e.g., positive for endothelial growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK)). Summarized updates in NSCLC patients with EGFR mutations after a tyrosine kinase inhibitor (TKI) and NSCLC patients who have received prior PD-(L)1 plus doublet chemotherapy treatment are included as well.

Of significance, first-line advanced or metastatic squamous NSCLC patients experienced a median PFS of 11.1 months (95% CI: 9.5 – 16.3 months). In addition, first-line patients with advanced or metastatic non-squamous tumors experienced a median PFS of 13.3 months (95% CI: 8.3 – 16.4 months). Median overall survival was not reached in either subset of patients after a median follow-up time of 22.1 months. The frequency of treatment-emergent adverse events (TEAEs) leading to the discontinuation of ivonescimab was 11.1% and 2.8%, respectively, in patients with squamous and non-squamous tumors. The most frequent TEAEs were anemia and decreased neutrophil counts in squamous patients and anemia and constipation in non-squamous patients.

The posters will be presented by, amongst others, Dr. Li Zhang, Sun Yat-Sen University Cancer Center, and Dr. West, with data generated and analyzed by our collaboration and licensing partner, Akeso Inc. (HKEX Code: 9926.HK) with contribution by Summit staff.

Summit continues its clinical development of ivonescimab in order to establish its efficacy and safety in two NSCLC indications:

  • HARMONi Phase III trial: ivonescimab combined with chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR TKI (NCT05184712)
  • HARMONi-3 Phase III trial: ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (NCT05899608)

About the ELCC 2024 Posters

Poster Title: Phase 2 Results of Ivonescimab a Novel PD-1/VEGF Bispecific in Combination with Chemotherapy for First Line Treatment of Patients with Advanced / Metastatic Squamous Non-Small Cell Lung Cancer

ELCC Presentation No.: 68P

Session Date & Time: Friday, March 22, 2024, 12:00 to 12:45pm CET

Poster Title: Intracranial Activity of Ivonescimab Alone or in Combination with Platinum Doublet Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer and Brain Metastases

ELCC Presentation No.: 174P

Session Date & Time: Friday, March 22, 2024, 12:00 to 12:45pm CET

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, the United States, Canada, Europe, and Japan, and as AK112 in China and Australia, is an investigational, novel, potential first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays cooperative binding with each of its intended targets with higher affinity when in the presence of both PD-1 and VEGF.

This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the tumor microenvironment with over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro, and over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro (Zhong, et al, SITC, 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.

Ivonescimab was discovered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 1,600 patients have been treated with ivonescimab in clinical studies globally. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two Phase III clinical trials.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority.

About Summit Therapeutics

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs.

Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol ‘SMMT’). We are headquartered in Miami, Florida, and we have additional offices in Menlo Park, California, and Oxford, UK.

For more information, please visit and follow us on X @summitplc.

Summit Forward-looking Statements

Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc., the Company’s anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, potential acquisitions, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, and global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of filings that the Company makes with the Securities and Exchange Commission. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

Appendix: Glossary of Critical Terms Contained Herein

Affinity – Affinity is the strength of binding of a molecule, such as a protein or antibody, to another molecule, such as a ligand.

Avidity Avidity is the accumulated strength of multiple binding interactions.

Angiogenesis – Angiogenesis is the development, formation, and maintenance of blood vessel structures. Without sufficient blood flow, tissue may experience hypoxia (insufficient oxygen) or lack of nutrition, which may cause cell death.i

Baseline – The condition of a patient at the start of the clinical trial; a patient’s health status upon starting a clinical trial prior to receiving therapy.

Cooperative binding – Cooperative binding occurs when the number of binding sites on the molecule that can be occupied by a specific ligand (e.g., protein) is impacted by the ligand’s concentration. For example, this can be due to an affinity for the ligand that depends on the amount of ligand bound or the binding strength of the molecule to one ligand based on the concentration of another ligand, increasing the chance of another ligand binding to the compound.ii

Immunotherapy – Immunotherapy is a type of treatment, including cancer treatments, that help a person’s immune system fight cancer. Examples include anti-PD-1 therapies.iii

Intracranial – Within the cranium or skull.

PD-1Programmed cell Death protein 1 is a protein on the surface of T cells and other cells. PD-1 plays a key role in reducing the regulation of ineffective or harmful immune responses and maintaining immune tolerance. However, with respect to cancer tumor cells, PD-1 can act as a stopping mechanism (a brake or checkpoint) by binding to PD-L1 ligands that exist on tumor cells and preventing the T cells from targeting cancerous tumor cells.iv

PD-L1Programmed cell Death Ligand 1 is expressed by cancerous tumor cells as an adaptive immune mechanism to escape anti-tumor responses, thus believed to suppress the immune system’s response to the presence of cancer cells. v

PD-L1 TPS – PD-L1 Tumor Proportion Score represents the percentage of tumor cells that express PD-L1 proteins.

PFSProgression-Free Survival.

RANOResponse Assessment in Neuro-Oncology, the standard for assessing the response of a brain or spinal cord tumor to therapy.

SQ-NSCLC – Non-small cell lung cancer tumors of squamous histology.

T Cells – T cells are a type of white blood cell that is a component of the immune system that, in general, fights against infection and harmful cells like tumor

Tetravalent – A tetravalent molecule has four binding sites or regions.

Tumor Microenvironment – The tumor microenvironment is the ecosystem that surrounds a tumor inside the body. It includes immune cells, the extracellular matrix, blood vessels and other cells, like fibroblasts. A tumor and its microenvironment constantly interact and influence each other, either positively or negatively.vii

VEGFVascular Endothelial Growth Factor is a signaling protein that promotes angiogenesis.viii

i Shibuya M. Vascular Endothelial Growth Factor (VEGF) and Its Receptor (VEGFR) Signaling in Angiogenesis: A Crucial Target for Anti- and Pro-Angiogenic Therapies. Genes Cancer. 2011 Dec;2(12):1097-105.

ii Stefan MI, Le Novère N. Cooperative binding. PLoS Comput Biol. 2013;9(6)

iii US National Cancer Institute, a part of the National Institute of Health (NIH). Accessed March 2024.

iv Han Y, et al. PD-1/PD-L1 Pathway: Current Researches in Cancer. Am J Cancer Res. 2020 Mar 1;10(3):727-742.

v Han Y, et al. PD-1/PD-L1 Pathway: Current Researches in Cancer. Am J Cancer Res. 2020 Mar 1;10(3):727-742.

vi Cleveland Clinic. Accessed March 2024.

vii MD Anderson Cancer Center. Accessed March 2024.

viii Shibuya M. Vascular Endothelial Growth Factor (VEGF) and Its Receptor (VEGFR) Signaling in Angiogenesis: A Crucial Target for Anti- and Pro-Angiogenic Therapies. Genes Cancer. 2011 Dec;2(12):1097-105.


Contact Summit Investor Relations:
Dave Gancarz

Chief Business & Strategy Officer

Nathan LiaBraaten

Senior Director, Investor Relations

Italfarmaco Receives FDA Approval for Duvyzat™ (givinostat) in Duchenne Muscular Dystrophy

Orally administered treatment for DMD approved in patients 6 years and older

EPIDYS trial met primary endpoint demonstrating statistically and clinically meaningful treatment benefit in one of the largest DMD phase 3 trials to date

Median follow-up of over 3 additional years in open label long-term safety and tolerability study

Italfarmaco also announces establishment of new U.S.-based subsidiary ITF Therapeutics to expand company focus on rare diseases and lead commercial launch for Duvyzat™

MILAN–(BUSINESS WIRE)–Italfarmaco S.p.A. announced today that the U.S. Food and Drug Administration (FDA) has approved Duvyzat™ (givinostat), a novel histone deacetylase (HDAC) inhibitor, for the treatment of patients 6 years or older with Duchenne muscular dystrophy (DMD), a rare X-linked progressive and life-limiting neuromuscular condition with symptoms from early childhood.

“The FDA’s approval of Duvyzat for DMD, based on our robust and successful clinical development program, reflects Italfarmaco’s commitment to providing a safe and proven-effective therapy that can have a meaningful impact for people living with DMD,” said Paolo Bettica, MD, PhD, Chief Medical Officer at Italfarmaco Group. “We are grateful for the support of those living with DMD and their dedicated caregivers, which played a central role in helping us reach this landmark FDA approval. Our focus now is to make Duvyzat available as a treatment for DMD management in the U.S. as quickly as possible.”

Dr Francesco De Santis, President of Italfarmaco Holding and Chairman of Italfarmaco Group added, “Duchenne muscular dystrophy is a disease with significant unmet medical need and Duvyzat has the potential to benefit a broad DMD patient population independent of the underlying gene mutation that causes the disease. The FDA approval highlights the dedication of Italfarmaco’s research and clinical teams to achieve this milestone for the company.”

The approval is based on the results of the pivotal multicentre, randomised, double-blind, placebo-controlled phase 3 EPIDYS trial (NCT02851797). In the EPIDYS study, a total of 179 ambulant boys six years of age or older received either Duvyzat twice daily or placebo, in addition to glucocorticosteroid treatment. The EPIDYS study met its primary endpoint demonstrating that patients on Duvyzat showed a statistically significant and clinically meaningful difference in time to complete the four-stair climb assessment. Duvyzat also showed favourable results on key secondary endpoints including North Star Ambulatory Assessment (NSAA), and fat infiltration evaluation by magnetic resonance imaging. The majority of adverse effects observed with Duvyzat were mild to moderate in severity. Results from this study were published in The Lancet Neurology in March 2024.

“There is a tremendous unmet need for novel therapies in DMD that can achieve meaningful benefits for a broad range of patients. Duvyzat’s unique mechanism of action has shown a positive risk/benefit profile and the ability to delay disease progression, supporting its potential to become a key component of the standard of care for people living with DMD,” added Craig M. McDonald, MD, Professor at the Department of Pediatrics and Physical Medicine Rehabilitation at the University of California Davis Health and investigator for the EPIDYS trial. “I would like to thank all patients and their families for participating in the clinical trials and for making this approval possible.”

“We are thrilled with the FDA’s approval of Duvyzat, a new therapy for DMD. It is an oral medication that will be available to every person 6 years and older with DMD. This brings great hope for the Duchenne community, and we believe this will be a key therapy to prevent disease progression in Duchenne,” said Pat Furlong, Founding President & CEO at Parent Project Muscular Dystropy (PPMD).

Italfarmaco has significantly expanded its U.S. presence through the formation of a new fully owned subsidiary, ITF Therapeutics LLC. ITF Therapeutics will be responsible for the commercialisation of Duvyzat in the U.S. and the company is working closely with healthcare providers, patient advocacy groups and payors to make Duvyzat available to patients.

Duvyzat received priority review, orphan drug and rare pediatric disease designations from the FDA. A Marketing Authorisation Application (MAA) for givinostat as a potential treatment for DMD has been submitted to the European Medicine Agency (EMA) and is currently under review. Italfarmaco has a global presence and is also working with other regulatory agencies.

About Duchenne Muscular Dystrophy

Duchenne muscular dystrophy (DMD) is a severe neuromuscular genetic disease characterised by progressive muscle weakness and degeneration and is the most common type of muscular dystrophy globally. DMD is caused by mutations in the dystrophin gene that result in the absence of a functional dystrophin protein. Without dystrophin, muscle fibres are highly susceptible to injury and this continuous muscle injury leads to chronic inflammation, impairment of muscle regeneration and muscle replacement by fibrotic and fat tissue. The disease primarily affects boys, with symptoms usually first seen between two and five years of age. Symptoms worsen over time affecting the ability to walk. Eventually, heart and respiratory muscles are affected, which are the two main causes of premature death. DMD incidence is approximately one in every 3500 – 6000 male births worldwide.

About Duvyzat™

Duvyzat is an investigational drug discovered through Italfarmaco’s research and development efforts in collaboration with Telethon and Duchenne Parent Project (Italy). Duvyzat is a histone deacetylase (HDAC) inhibitor that modulates the deregulated activity of HDACs in the dystrophic muscle, which is a major consequence of the lack of dystrophin associated with DMD. Duvyzat’s mechanism of action has the potential to inhibit HDAC pathological overactivity in an effort to address the cascade of events leading to muscle damage, thereby counteracting the disease pathology and slowing down muscle deterioration.


Founded in 1938 in Milan, Italy, Italfarmaco is a private global pharmaceutical company that has led the successful development and approval of many pharmaceutical products around the world. The Italfarmaco group has operations in more than 60 countries through directly controlled or affiliated companies. The company is a leader in pharmaceutical research, product development, production and commercialisation with proven success in many therapeutic areas including immuno-oncology, gynaecology, neurology, cardiovascular disease and rare diseases. Italfarmaco’s rare disease unit includes programmes in Duchenne muscular dystrophy, Becker muscular dystrophy, amyotrophic lateral sclerosis and polycythaemia vera.

Indication and Important Safety Information

What is DUVYZAT?

DUVYZAT is a prescription medicine that is used for the treatment of Duchenne muscular dystrophy (DMD) in people 6 years of age and older.

It is not known if DUVYZAT is safe and effective in children under 6 years of age.

Important Safety Information

What is the most important information I should know about DUVYZAT?

  • Low platelet counts in your blood (thrombocytopenia). Platelets are important for blood clotting, and a decrease in their numbers can lead to an increased risk of bleeding or bruising. Your healthcare provider will check your blood count before you start DUVYZAT and regularly during treatment for any signs of thrombocytopenia. Call your healthcare provider right away if you notice any unusual bleeding or small red or purple spots on the skin called petechiae. Your healthcare provider may change your dose of DUVYZAT if your blood platelet counts continue to be low or may stop your treatment with DUVYZAT.
  • Increased levels of fat (triglycerides) in your blood. You may not have any symptoms, so your healthcare provider will do blood tests before you start DUVYZAT and regularly during treatment to check your triglyceride levels. Your healthcare provider may change your dose of DUVYZAT if your triglyceride levels continue to be high or may stop your treatment with DUVYZAT.
  • Frequent watery loose stools (diarrhea) and vomiting. DUVYZAT can cause vomiting and moderate to severe diarrhea. If diarrhea occurs, you should keep track of the frequency and severity of your diarrhea symptoms, drink plenty of fluids, and contact your healthcare provider. Your healthcare provider may change your dose of DUVYZAT if the diarrhea cannot be managed or does not go away. Your healthcare provider may also stop your treatment with DUVYZAT.

Before taking DUVYZAT, tell your healthcare provider about all of your medical conditions, including if you:

  • have any heart problems or if you take any medicines that could increase your chance for irregular heart rhythms.
  • have any bleeding problems.

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

Taking DUVYZAT with certain other medicines may affect each other. Taking DUVYZAT with other medicines can cause serious side effects. Do not start or stop other medicines without talking to your healthcare provider.

DUVYZAT can cause serious side effects, including:

  • See “What is the most important information I should know about DUVYZAT?”
  • changes in the electrical activity of your heart called QT Prolongation. QT Prolongation can increase the risk of developing a type of irregular heart rhythm known as Torsades de Pointes. Call your healthcare provider right away if you feel faint, have an irregular heartbeat, feel dizzy, or lose consciousness.

The most common side effects of DUVYZAT included diarrhea, nausea, vomiting, stomach pain, low platelet counts in the blood, increased fat level in the blood and fever.

These are not all of the possible side effects of DUVYZAT. For more information, ask your healthcare provider or pharmacist.

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

Please see full Prescribing Information and Medication Guide.


Media enquiries U.S.A:
Brian Connor |+1 212 253 8881|

Media enquiries Global:
Charlotte Spitz or Jacob Verghese |+49 (0)151 7441 6179 |

Other enquiries U.S.A:
Patient Advocacy and Communications Lead U.S.A.|

Other enquiries Global:
Patient Advocacy and Communications Lead|

Flosonics Medical Secures $20 Million USD in Series C Funding Led by New Leaf Venture Partners to Accelerate Growth

SUDBURY, Ontario–(BUSINESS WIRE)–#flopatch–Flosonics Medical, a leader in wearable medical ultrasound, today announced its Series C financing, raising $20 million USD. The round was led by New Leaf Venture Partners, with participation from previous investors Arboretum Ventures, Genesys Capital, and iGan Partners. This new funding will support Flosonics as the company continues to innovate and drive market adoption of FloPatch, a first-in-class wearable Doppler ultrasound for hemodynamic assessments.

Vijay Lathi, an experienced MedTech investor with a focus on data convergence and guiding growth-stage companies, will join Flosonics Medical’s board of directors. “We are thrilled to have New Leaf Venture Partners lead our Series C round and welcome Vijay Lathi to our board,” said Joe Eibl, CEO of Flosonics Medical. “This investment not only validates our past successes but also enables us to accelerate our plans for expansion and innovation. We are committed to leveraging this funding to further enhance the standard of care for critically ill patients with FloPatch and expand our reach into new markets.”

On behalf of New Leaf Venture Partners, Vijay Lathi expressed enthusiasm about the partnership: “Our investment into Flosonics is driven by the clear and significant impact their technology will have on patients in critical situations, and the quality of the team behind it. Flosonics Medical stands at the forefront of wearable ultrasound, and we look forward to contributing to their continued success.”

Flosonics Medical plans to use the Series C investment to accelerate commercial growth, expand indications for use, and continue evidence generation. The company aims to address the growing demand for wearable AI-assisted sensors to improve patient management inside and outside the hospital.

About: Flosonics Medical is a Canadian medical device company engaged in the research and development of innovative ultrasound technology. Founded in 2015, the company’s mission is to improve patient care and the practice of medicine through technology-enabled solutions and ground-breaking clinical research.

About New Leaf Venture Partners: New Leaf Venture Partners is a leader in healthcare technology venture investing. Our investment professionals bring a unique blend of technical, operational, and clinical experience to our investments, working closely with our entrepreneurs and management teams to help build successful companies. New Leaf Ventures invests in both healthcare-related information technology companies as well as public and private biopharmaceutical companies as well as. New Leaf currently manages over $500 million in assets through several funds. New Leaf was formed in 2005 as the healthcare spinoff from the Sprout Group, one of the oldest U.S. venture capital funds. For more information please visit


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InnoCare Announces Approval of Clinical Trial of BCL2 Inhibitor ICP-248 in Combination with Orelabrutinib as First-Line Therapy for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in China

BEIJING–(BUSINESS WIRE)–InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today the approval of the Investigational New Drug (IND) to conduct the clinical trial of B-cell lymphoma-2 (BCL2) inhibitor ICP-248 in combination with Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib as first-line therapy for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in China.

This multicenter, randomized-controlled, open-label clinical study is designed to evaluate the efficacy and safety of ICP-248 combined with orelabrutinib versus immunochemotherapy in treatment-naive patients with CLL/SLL.

ICP-248 is a novel, orally bioavailable BCL2-selective inhibitor, which aims to treat hematologic malignancies as a monotherapy or in combination with other therapies. BCL2 is an important regulatory protein of apoptosis pathway, and its abnormal expression is related to the development of various hematologic malignancies. ICP-248 has an anti-tumor effect by selectively inhibiting BCL2 and restoring the mechanism of programmed cell death. The preliminary result has demonstrated a good efficacy and safety profile.

Orelabrutinib has been approved for marketing in China and Singapore, and all three approved indications related to lymphoma have been included in the National Reimbursement Drug List (NRDL) in China. In the treatment of relapsed/refractor CLL/SLL patients with orelabrutinib, the overall response rate and complete response rate reached 93.8% and 30% respectively, demonstrating an outstanding efficacy and safety profile.

Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare, said, “InnoCare has developed strong pipeline in hemato-oncology that covers a variety of important hemato-oncology targets, including BTK, BLC2, CD19, CD20xCD3, E-3 ligase, etc. ICP-248 and orelabrutinib are important global assets of our company in the field of hematology, with multiple clinical studies conducted in China and the United States. We will accelerate clinical development and look forward to providing CLL/SLL patients with more efficient and safe treatment options.”

CLL/SLL, one of the most common types of leukemia, is an indolent malignancy of B lymphocytes. There are 191,000 newly diagnosed CLL cases and 61,000 deaths every year globally1. The incidence rate of CLL/SLL is on the rise in China2.

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.

InnoCare Forward-looking Statements

This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management’s intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.


1 American Journal of Hematology
2 Ybanlv


Chunhua Lu



Astrocyte Pharmaceuticals Announces FDA Clearance of its Investigational New Drug Application for AST-004

Green Light for Phase 2 Trial of AST-004 in Acute Ischemic Stroke Patients

GROTON, Conn., March 12, 2024 (GLOBE NEWSWIRE) — Astrocyte Pharmaceuticals Inc., a clinical-stage biopharmaceutical company committed to advancing cerebroprotective therapies for individuals suffering from stroke, traumatic brain injury (TBI), and concussion, has announced today the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for its lead program, AST-004, for acute ischemic stroke. The company is preparing to initiate a Phase 2 clinical trial. The IND application clearance also paves the way for additional studies further exploring AST-004 in stroke, as well as TBI, and concussion.

Currently, only ~5% of stroke patients receive pharmaceutical therapy, largely due to the short treatment windows of available thrombolytic medicines, as well as their need for imaging before those treatments can be initiated. AST-004 was developed with the potential to treat all stroke patients. Unlike existing therapies, treatment with AST-004 is designed for use without the need for imaging in the emergency room and for use at any point after diagnosis. And it has the potential to treat stroke occurring in any sized blood vessel in the brain.

The upcoming Phase 2 trial in acute ischemic stroke patients builds upon the recent successful stroke clinical trial designs used by medical device companies, heralding a new era in patient care. “The past decade has witnessed a transformative shift in stroke trials, thanks to sophisticated imaging techniques that enable high-quality real-time characterization of stroke and ensure selection of homogeneous study groups,” said Dr. Kevin Sheth, Co-Director of the Center for Brain & Mind Health at the Yale School of Medicine and Chief Medical Advisor to Astrocyte. “The new study of AST-004 will first focus on treating those stroke patients with large vessel occlusions, offering hope to significantly diminish brain damage.”

AST-004 is an innovative small molecule therapy that has demonstrated exceptional promise in preclinical studies. In a critical non-human primate stroke model, a significant reduction in brain lesion growth by 64% and an overall lesion size decrease by 45% were observed with a high dose (as reported in ‘The Journal Stroke’ in 2022). Astrocyte previously completed two Phase 1 safety trials in Europe, involving 80 participants in total, and saw no significant adverse effects or safety concerns.

Dr. William Korinek, CEO of Astrocyte Pharmaceuticals, commented, “Since our founding in 2014, we have been focused on demonstrating the potential of cerebroprotective benefits of AST-004. Our robust preclinical program and Phase 1 studies have laid the foundation for our ongoing development efforts, and we are eager to move forward with the planned Phase 2 study. Stroke is the second leading cause of death globally, and the need for advances in treatment is enormous. We believe AST-004 can be part of that solution.”

About Astrocyte Pharmaceuticals Inc.

Astrocyte Pharmaceuticals Inc. is a privately held, clinical-stage drug discovery and development company dedicated to accelerating the recovery and well-being of brain injury patients. The company is committed to proving the cerebroprotective benefits of enhancing astrocyte function and advancing breakthrough therapeutic agents for treating brain injury resulting from stroke, traumatic brain injury, concussion, and neurodegenerative disorders such as Alzheimer’s disease. For more information on Astrocyte Pharmaceuticals Inc. and the AST-004 program, please visit us at Astrocyte Pharmaceuticals Inc.  

Forward-Looking Statement

This press release contains certain forward-looking statements regarding, among other things, statements relating to goals, plans, and projections regarding the company’s financial position, results of operations, market position, product development, and business strategy. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert, or change any of them and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and the company undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

Media contact:
Kimberly Macleod –