Crown Bioscience Recognized Once Again as T+ Employer® for the Third Year in a Row

Crown Bioscience Recognized Once Again as T+ Employer® for the Third Year in a Row




Crown Bioscience Recognized Once Again as T+ Employer® for the Third Year in a Row

SAN DIEGO–(BUSINESS WIRE)–Crown Bioscience, a global contract research organization (CRO) and JSR Life Sciences company, solidifies its stature as a frontrunner in the global healthcare sector by securing the T+ Employer® certification for healthcare excellence every year since the award was inaugurated in 2020.


This prestigious accolade, awarded by the Health Human Resources Development Center of the National Health Commission of China and MedTalent, highlights the company’s unwavering dedication to fostering a landmark corporate culture marked by inclusivity, innovation, and a seamless customer service.

The T+ Employer® certification celebrates Crown Bioscience’s impactful values and trendsetting role within the pharmaceutical, medical, life science, and virtual healthcare industries. This recognition is a testament to its pioneering leadership, which is validated through rigorous evaluation that includes enterprise research, professional public surveys, insights from key opinion leaders, and campus studies.

Company-wide initiatives such as significant contributions to oncology research and promoting cross-regional departmental collaboration via digitization and human systems have distinguished Crown Bioscience as a paradigm of employer excellence.

Shirley Huang, MBA, Senior Vice President of Human Resources, said: “The reaffirmation of the T+ Employer® certification is more than an accolade, it symbolizes the commitment of our talented team and the harmony with our values. In an ever-evolving industry landscape, this award is a testament to our ongoing efforts to merge our business goals with a supportive and thriving work culture.”

Launched by the MedTalent and Med+ Institute as the healthcare industry’s inaugural employer certification, the T+ Employer® certification has become a symbol of employment distinction and a beacon for healthcare businesses aspiring to excellence.

This achievement underscores Crown Bioscience’s dedication to setting high standards and pushing the boundaries of innovation across all facets of its business. It reflects the company’s strong resolve to enrich the work environment, consistently deliver beyond client expectations, and elevate industry standards.

About Crown Bioscience

Crown Bioscience, a JSR Life Sciences company, is a global Contract Research Organization (CRO) partnering with biotech and pharmaceutical companies to rapidly advance the discovery and development of oncology drugs. As the exclusive preclinical CRO providing tumor organoid services with the well-established Hubrecht Organoid Technology, we offer over 600 organoid models spanning 22 cancer indications. Furthermore, we have developed the world’s largest commercially available PDX collection. Our focus on helping our customers develop novel therapies aims to ensure that patients receive the right treatment at the right time. Founded in 2006, we have 13 facilities across the US, Europe, and Asia. For more information, please visit www.crownbio.com

Contacts

Media Inquiries:
Crown Bioscience

Sarah Martin-Tyrrell

pr@crownbio.com

GE HealthCare Accelerates AI Innovation with Healthcare-Specific Foundation Models Powered by NVIDIA

GE HealthCare Accelerates AI Innovation with Healthcare-Specific Foundation Models Powered by NVIDIA




GE HealthCare Accelerates AI Innovation with Healthcare-Specific Foundation Models Powered by NVIDIA

  • Using NVIDIA Technology, SonoSAMTrack¹ demonstrates its pliability and applicability in ultrasound image segmentation, consistently delivering high-quality results over a wide range of demanding datasets and conditions

SAN JOSE, Calif.–(BUSINESS WIRE)–Building on a long-term artificial intelligence (AI) collaboration, GE HealthCare used NVIDIA technology to develop its recent research model SonoSAMTrack1, which combines a promptable foundation model for segmenting objects on ultrasound images called SonoSAM1. SonoSAMTrack focuses on segmenting anatomies, lesions, and other essential areas in ultrasound images. SonoSAMLite is a streamlined version of SonoSAMTrack.

“GE HealthCare is committed to investing in innovative technologies that help tackle some of the industry’s biggest challenges. Our vision is to accelerate advancements in medical imaging by introducing foundational AI technologies, thereby empowering data scientists to expedite AI application development and eventually help clinicians and enhance patient care. By utilizing these versatile, generalist models, we aim to adapt more efficiently to new tasks and medical imaging modalities, often requiring far less labeled data compared to the traditional model retraining approach. This is particularly significant in the healthcare domain, for which data is especially time-consuming and costly to obtain,” said Parminder Bhatia, Chief AI Officer, GE HealthCare.

In healthcare, leveraging AI to enhance patient care, streamline operational efficiencies, and make informed decisions has become increasingly important. Traditionally, the approach to integrating AI into healthcare systems required the retraining of models to accommodate the unique requirements of different patient populations and hospital settings. This conventional method can lead to heightened costs, complexity, and the need for specialized personnel, therefore hindering the broad adoption of AI technologies in healthcare domains. Foundation models have risen to prominence due to their ability to operate as human-in-the-loop AI systems, garnering significant attention.

Foundation and generative AI models could play a crucial role by enabling swift adaptation to various diseases, facilitating screening, early detection, tracking progression, and identifying non-invasive biomarkers with minimal training requirements, such as zero-shot or few-shot settings. In a recent study conducted by GE HealthCare, its research project, SonoSAMTrack, showcased high performance across seven ultrasound datasets, encompassing a wide range of anatomies (adult heart and fetal head) and pathologies (breast lesions and musculoskeletal pathologies), as well as different scanning devices. Notably, it outperformed competing methods by a substantial margin. In addition, SonoSamTrack exhibited enhanced performance metrics in terms of speed and efficiency, requiring only 2-6 clicks for precise segmentation, thus minimizing user input2. This achievement was made possible through distillation and quantization techniques, utilizing the NVIDIA TensorRT software development kit and other capabilities for quantization-aware training.

“Combining NVIDIA’s accelerated computing and AI technology stack with GE HealthCare’s medical imaging expertise will help enhance patient care by making ultrasound diagnostics quicker and more accurate,” said David Niewolny, Director of Business Development for Healthcare and Medical, NVIDIA. “This collaboration underscores the importance of using AI for life-saving advancements and setting new standards in healthcare.”

To learn more about SonoSAM, please visit here.

1 Technology in development that represents ongoing research and development efforts. These technologies are not products and may never become products. Not for sale. Not cleared or approved by the U.S. FDA or any other global regulator for commercial availability.

2 Hariharan Ravishankar, Rohan Patil, Vikram Melapudi, Harsh Suthar, Stephan Anzengruber, Parminder Bhatia, Kass-Hout Taha, Pavan Annangi. SonoSAMTrack — Segment and Track Anything on Ultrasound Images. https://doi.org/10.48550/arXiv.2310.16872

About GE HealthCare Technologies Inc.

GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 100 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are a $19.6 billion business with 51,000 colleagues working to create a world where healthcare has no limits.

Follow us on Facebook, LinkedIn, Twitter, Instagram, and Insights for the latest news, or visit our website https://www.gehealthcare.com/ for more information.

Contacts

Linh Dinh

Global Communications Director, Science & Technology

M 408.275.5682

Linh.Dinh@gehealthcare.com

Cadence and NVIDIA Unveil Groundbreaking Generative AI and Accelerated Compute-Driven Innovations

Cadence and NVIDIA Unveil Groundbreaking Generative AI and Accelerated Compute-Driven Innovations




Cadence and NVIDIA Unveil Groundbreaking Generative AI and Accelerated Compute-Driven Innovations

Cadence Reality Digital Twin Platform integrated with NVIDIA Omniverse and Orion molecular design platform accelerated with NVIDIA BioNeMo will transform the future of design

SAN JOSE, Calif.–(BUSINESS WIRE)–Cadence Design Systems, Inc. (Nasdaq: CDNS) today announced an expansion of its multi-year collaboration with NVIDIA across EDA, system design and analysis, digital biology and AI with the unveiling of two transformative solutions to reinvent design using accelerated computing and generative AI.


First, the new Cadence® Reality Digital Twin Platform is the industry’s pioneering comprehensive digital twin solution to facilitate speed-of-light acceleration of the design, simulation and optimization of data centers across multiple industries. The platform virtualizes the entire data center and uses AI, high-performance computing (HPC) and physics-based simulation to significantly improve data center energy efficiency by up to 30%.

The Cadence Reality platform’s integration with NVIDIA Omniverse brings OpenUSD data interoperability and physically based rendering to the digital twin solution—helping accelerate data center design and simulation workflows by 30X.

Second, the companies are collaborating on generative AI to dramatically accelerate approaches to drug discovery. Cadence’s cloud-native molecular design platform Orion® will now be supercharged with NVIDIA’s generative AI tool, NVIDIA BioNeMo, and NVIDIA microservices for drug discovery to broaden therapeutic design capabilities and shorten time to trusted results. The collaboration brings together decades of expertise in scientific software and accelerated computing from the two companies to deliver transformative approaches to drug discovery. Accelerated by on-demand GPU access at an unprecedented scale, pharmaceutical companies can quickly and reliably generate and assess design hypotheses across a range of therapeutic modalities, including biologics, peptides and small molecules.

“The broadening collaboration between NVIDIA and Cadence is having a transformative impact on everything from data center design to drug discovery,” said Dr. Anirudh Devgan, president and CEO, Cadence. “As AI rapidly becomes a keystone technology driving data center and data center workload expansion, the Cadence Reality Digital Twin Platform integration with NVIDIA Omniverse will optimize every aspect of data center design and operations, use energy more efficiently, and pave the way for a more efficient, resilient, and environmentally friendly future. Our groundbreaking efforts with NVIDIA to integrate BioNeMo with our industry-leading Orion molecular design tools hold great promise for unlocking new ideas and transforming the future of therapeutics and drug discovery. Together, NVIDIA and Cadence are leading the AI revolution.”

“Digital twins will transform manufacturing, drug discovery and countless other industries,” said Jensen Huang, founder and CEO of NVIDIA. “Using NVIDIA Omniverse and generative AI technologies, Cadence can deliver simulation and digitalization technologies to benefit individuals, companies and societies in ways we have yet to imagine.”

Growing Importance of Digital Twin Technology

Digital twin technology is increasingly becoming critical to designers and operators of complex data center systems in the AI era as through creating a virtual replica of a physical system, it can use real-time data to simulate its behavior, performance and interactions in various conditions. The Cadence Reality platform provides visibility across the entire value chain, enabling data center designers and operators to simulate the performance of integrated liquid and air-cooling systems, visualize the performance of data centers and plan for what-if scenarios.

The company’s collaboration with NVIDIA also expands the capabilities of the Orion drug discovery platform by providing key capabilities, including access to BioNeMo models for structure prediction, small molecule generation and molecular property prediction. Molecules generated with BioNeMo may then be profiled and iteratively enhanced and designed with Orion tools.

Today’s announcements build upon Cadence and NVIDIA’s long-standing collaboration in areas such as:

  • AI-driven digital and custom IC design, including PPA, schedule and cost reduction of NVIDIA GPUs with Cadence Innovus and Cadence Cerebrus solutions
  • Over 20 years of partnership in hardware and software verification, including Palladium®, Protium, and now Cadence Verisium technologies
  • System design and analysis, including GPU-optimized Cadence Fidelity CFD Software and the revolutionary Cadence Millennium Enterprise Multiphysics Platform

These announcements also open a new chapter of Cadence’s Intelligent System Design strategy to help customers develop differentiated products across a wide range of industries and market verticals.

About Cadence

Cadence is a pivotal leader in electronic systems design, building upon more than 30 years of computational software expertise. The company applies its underlying Intelligent System Design strategy to deliver software, hardware and IP that turn design concepts into reality. Cadence customers are the world’s most innovative companies, delivering extraordinary electronic products from chips to boards to complete systems for the most dynamic market applications, including hyperscale computing, 5G communications, automotive, mobile, aerospace, consumer, industrial and healthcare. For nine years in a row, Fortune magazine named Cadence one of the 100 Best Companies to Work For. Learn more at cadence.com.

© 2024 Cadence Design Systems, Inc. All rights reserved worldwide. Cadence, the Cadence logo and the other Cadence marks found at www.cadence.com/go/trademarks are trademarks or registered trademarks of Cadence Design Systems, Inc. All other trademarks are the property of their respective owners.

Category: Featured

Contacts

Cadence Newsroom

408-944-7039

newsroom@cadence.com

KORU Medical Systems to Present Data Demonstrating 97% Adherence on Its Freedom Infusion System for Large Volume Subcutaneous Administration at NHIA 2024 Conference

KORU Medical Systems to Present Data Demonstrating 97% Adherence on Its Freedom Infusion System for Large Volume Subcutaneous Administration at NHIA 2024 Conference




KORU Medical Systems to Present Data Demonstrating 97% Adherence on Its Freedom Infusion System for Large Volume Subcutaneous Administration at NHIA 2024 Conference

MAHWAH, N.J.–(BUSINESS WIRE)–KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, is pleased to announce data on the impact of the Freedom Infusion System on subcutaneous immunoglobulin (SCIg) therapy for primary immunodeficiency diseases (PIDD) to be presented at the National Home Infusion Association (NHIA) 2024 Conference. The conference will take place from March 23 to 27 in Austin, Texas.

The study, authored by KORU Medical, analyzed data from a large national specialty pharmacy, capturing drug receipts over 4.5 years for 3,787 US PIDD patients using KORU Medical FREEDOM60® and FreedomEdge® infusion systems for self-administered SCIg therapy. Ages ranged from 1 year to 98 years, with a mean of 50.1 years. Patient drug administration volumes ranged from 5mL to greater than 100mL with the majority of patients administering under 50mL. Adherence to SCIg therapy using the KORU Medical FREEDOM60® and FreedomEdge® infusion systems was calculated at 97%.

The abstract, titled “Exploring the Impact of KORU Freedom Infusion Systems on Subcutaneous Immunoglobulin Therapy for Primary Immunodeficiency: Insights from a Large-Scale Database Analysis,” will be presented by Brent Rutland, Vice-President of Medical Affairs for KORU Medical. This study represents the largest cohort of PIDD patients in the literature. We believe it provides valuable insights into the effectiveness of KORU Medical’s Freedom Infusion System in promoting treatment compliance in large volume subcutaneous delivery.

“These findings highlight the positive impact of KORU Medical’s Freedom Infusion System on subcutaneous immunoglobulin therapy for patients with primary immunodeficiency disease,” said Brent Rutland, Vice President, Medical Affairs at KORU Medical. “The high adherence rate underscores the effectiveness of KORU Medical’s pumps in promoting treatment compliance and improving patient outcomes. These results, with the KORU Freedom Infusion System, also demonstrate the company’s potential to support a broader range of developmental subcutaneous drug therapies.”

About KORU Medical Systems

KORU Medical develops, manufactures, and commercializes innovative and patient-centric large volume subcutaneous infusion solutions that improve quality of life for patients around the world. The FREEDOM Syringe Infusion System (the “Freedom System”) currently includes the FREEDOM60® and FreedomEdge® Syringe Infusion Drivers, Precision Flow Rate Tubing and HIgH-Flo Subcutaneous Safety Needle Sets. These devices are used for infusions administered in the home and alternate care settings. For more information, please visit www.korumedical.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. All statements that are not historical fact are forward-looking statements and can be identified by words such as “will,” “believe” and “potential”. Actual results may differ materially from these statements due to potential risks and uncertainties such as, among others, those risks and uncertainties included under the captions “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, which is on file with the SEC and available on our website at www.korumedical.com/investors and on the SEC website at www.sec.gov. All information provided in this release and in the attachments is as of March 18, 2024. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. We undertake no duty to update this information unless required by law.

Contacts

Investor Contact:
Louisa Smith

investor@korumedical.com

Neurogene Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Updates

Neurogene Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Updates




Neurogene Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Updates

Expanded Phase 1/2 gene therapy trial for Rett syndrome to inform future registrational study design; Company remains on track to share interim clinical data in 4Q:24

Strong financial position with runway into 2H:26 following reverse merger and private financing in December 2023

NEW YORK–(BUSINESS WIRE)–Neurogene Inc. (Nasdaq: NGNE), a clinical-stage company founded to bring life-changing genetic medicines to patients and families affected by rare neurological diseases, today announced fourth quarter and full year 2023 financial results and highlighted recent corporate updates.


We started the year with strong execution in our Phase 1/2 NGN-401 gene therapy trial for female pediatric patients with Rett syndrome, meeting our goal to expand the trial and add a high-dose cohort. We believe this expanded dataset will support future regulatory discussions to align on the design of a potential registrational study,” said Rachel McMinn, Ph.D., Chief Executive Officer and Founder of Neurogene. “NGN-401 has the potential to be a best-in-class treatment option with a targeted route of administration to deliver full-length, functional copies of the MECP2 gene. We are pleased that NGN-401 has been well-tolerated in all three patients dosed, with no signs of overexpression-related toxicity, demonstrating the potential of our EXACT transgene regulation technology to constrain MECP2 levels within a narrow and therapeutically relevant range. As we look ahead, we remain on track for interim clinical data from the NGN-401 trial in the fourth quarter of this year.”

Continued Dr. McMinn, “Our decision to execute a reverse merger, along with the concurrent private financing, provides us with cash runway into the second half of 2026, beyond key inflection points in our NGN-401 program and our NGN-101 program for CLN5 Batten disease. We look forward to sharing data from both programs later this year and continuing to advance our pipeline to enable an additional development candidate using EXACT in 2025.”

Fourth Quarter 2023 and Recent Highlights, and Anticipated Milestones

Phase 1/2 Trial of NGN-401 Gene Therapy for Treatment of Rett Syndrome

  • As previously planned, amended the protocol, expanding the trial to include more patients in low-dose Cohort 1 and added a high-dose Cohort 2; these updates are expected to provide a robust dataset and inform the design of a future registrational study
  • Remains on track to report interim clinical data from Cohort 1 in the fourth quarter of 2024; additional interim data, including from Cohort 2, are expected in the second half of 2025
  • Dosed the third patient early in the first quarter of 2024; removed the dosing stagger in Cohort 1, enabling the remaining patients in the cohort to be dosed in parallel
  • Plans to complete enrollment in Cohort 1 in the second half of 2024; enrollment in Cohort 2 is expected to begin in the second quarter of 2024
  • Reported that NGN-401 has been generally well-tolerated and there have been no treatment-emergent or procedure-related serious adverse events or signs of overexpression-related toxicity observed in any patient
  • Received NGN-401 clinical trial application approval from the United Kingdom (“UK”) Medicines and Healthcare products Regulatory Agency and working to on-board clinical sites in the UK

Phase 1/2 Trial of NGN-101 Gene Therapy for Treatment of CLN5 Batten Disease

  • Continuing enrollment in high-dose Cohort 3, and expects to provide interim clinical data and regulatory update in the second half of 2024

Additional Corporate Updates

  • Expanded the leadership team with appointment of Julie Jordan, M.D., as Chief Medical Officer; Dr. Jordan brings more than 20 years of experience to Neurogene, including design and execution of clinical trials for central nervous system disorders and gene therapies
  • Completed reverse merger and concurrent private placement of $95 million, and began trading on the Nasdaq Global Market under “NGNE” in mid-December 2023
  • Continues to expect to advance one additional product candidate, using EXACT technology, from the discovery stage into the clinic in 2025

Fourth Quarter and Full Year 2023 Financial Results

  • Cash and Cash Equivalents: Cash, cash equivalents and investments as of December 31, 2023 were $197.2 million.
  • Research & Development (“R&D”) Expenses: R&D expenses were $12.2 million and $44.4 million for the three and twelve months ended December 31, 2023, respectively, compared to $11.0 million and $47.5 million for the three and twelve months ended December 31, 2022, respectively. The decrease in R&D expenses for the twelve months ended December 31, 2023 was primarily driven by a decrease in manufacturing and development and pre-clinical costs offset by increased clinical trial costs.
  • General & Administrative (“G&A”) Expenses: G&A expenses were $2.5 million and $11.2 million for the three and twelve months ended December 31, 2023, respectively, compared to $2.0 million and $9.0 million for the three and twelve months ended December 31, 2022, respectively. The increase in G&A expenses for the twelve months ended December 31, 2023 was primarily driven by an increase in personnel costs, increased professional and consulting fees related to the reverse merger, and increased insurance and information technology costs. Due to the timing of the closing of the reverse merger in mid-December 2023, additional transaction-related expenses are expected to be recognized in the first quarter of 2024.
  • Net Income and Net Loss: Net income was $2.4 million and net loss was $36.3 million for the three and twelve months ended December 31, 2023, respectively, compared to net loss of $12.3 million and $55.2 million for the three and twelve months ended December 31, 2022, respectively. Net income for the three months ended December 31, 2023 included a one-time $16.4 million bargain purchase gain related to the reverse merger.

Upcoming Events

  • Stifel 2024 Virtual CNS Days: Management will participate in a fireside chat on Wednesday, March 20 at 9:30 a.m. ET

About Neurogene

The mission of Neurogene is to treat devastating neurological diseases to improve the lives of patients and families impacted by these rare diseases. Neurogene is developing novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. This includes selecting a delivery approach to maximize distribution to target tissues and designing products to maximize potency and purity for an optimized efficacy and safety profile. The Company’s novel and proprietary EXACT transgene regulation platform technology allows for the delivery of therapeutic levels while limiting transgene toxicity associated with conventional gene therapy. Neurogene has constructed a state-of-the-art gene therapy manufacturing facility in Houston, Texas. CGMP production of NGN-401 was conducted in this facility and will support pivotal clinical development activities. For more information, visit www.neurogene.com.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release which are not historical in nature are intended to be, and hereby are identified as, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current expectations and beliefs of the management of Neurogene, as well as assumptions made by, and information currently available to, management of Neurogene, including, but not limited to, statements regarding: the therapeutic potential and utility, efficacy and clinical benefits of NGN-401; the safety and tolerability profile of NGN-401; trial designs, clinical development plans and timing for NGN-401, including anticipated timing of enrollment in and clinical trial results from the Company’s NGN-401 Phase 1/2 trial for Rett syndrome; effects of the removal of staggered dosing in Cohort 1; initiation of new clinical sites for NGN-401 in the UK; expected interactions with the FDA regarding NGN-101; nomination of additional preclinical product candidates; and our expected cash resources and liquidity. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “on track,” and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Forward-looking statements are based on current beliefs and assumptions that are subject to risks, uncertainties and assumptions that are difficult to predict with regard to timing, extent, likelihood, and degree of occurrence, which could cause actual results to differ materially from anticipated results and many of which are outside of Neurogene’s control. Such risks, uncertainties and assumptions include, among other things: risks related to the timing and success of enrolling patients in the expanded cohort of our Phase 1/2 clinical trial of NGN-401 for the treatment of Rett syndrome; the expected timing and results of dosing of patients in our clinical trials, including NGN-401; the potential that we may not be able to expand our Phase 1/2 clinical trial of NGN-401 for the treatment of Rett syndrome into the UK based on a variety of factors, including but not limited to any decisions of regulatory authorities, costs of expanding the trial in the UK, the availability of suitable clinical test sites, and the ability to enroll patients in the UK or other reasons; the potential for negative impacts to patients resulting from using a higher dose of NGN-401 in Cohort 2 of the Phase 1/2 clinical trial for the treatment of Rett syndrome; the risk that we may not be able to report our data on the predicted timeline; our limited operating history; the risk that we may not be able to raise adequate additional capital to finance our operations, complete our clinical trials and commercialize our products; risks related to our ability to obtain regulatory approval for, and ultimately commercialize, our product candidates, including NGN-401; risks related to the outcome of non-clinical testing and early clinical trials for our product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; risks related to our limited experience in designing clinical trials and lack of experience in conducting clinical trials; and other risks and uncertainties identified under the heading “Risk Factors” included in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 18, 2024, and other filings that the Company has made and may make with the SEC in the future. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that the contemplated results of any such forward-looking statements will be achieved. Forward-looking statements in this communication speak only as of the day they are made and are qualified in their entirety by reference to the cautionary statements herein. Except as required by applicable law, Neurogene undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

This communication contains hyperlinks to information that is not deemed to be incorporated by reference into this communication.

– Financial Tables Follow –

Neurogene Inc.

Condensed Consolidated Balance Sheet Data

(In thousands of U.S. dollars)

 

 

December 31,

2023

 

December 31,

2022

Assets

 

 

 

Cash and cash equivalents

$

148,210

 

$

82,021

Other current assets

 

52,138

 

 

2,698

Non-current assets

 

22,225

 

 

24,546

Total assets

$

222,573

 

$

109,265

Liabilities

 

 

 

Current liabilities

$

22,973

 

$

6,651

Non-current liabilities

 

13,576

 

 

3,987

Total liabilities

 

36,549

 

 

10,638

Total convertible preferred stock

 

 

 

244,366

Stockholders’ equity (deficit)

 

186,024

 

 

(145,739)

Total liabilities, convertible preferred stock and stockholders’ equity (deficit)

$

222,573

 

$

109,265

Neurogene Inc.

Condensed Consolidated Statements of Operations

(In thousands of U.S. dollars, except share information)

 

 

Year Ended December 31,

 

2023

 

2022

Operating expenses:

 

 

 

Research and development

$

44,394

 

$

47,505

General and administrative

 

11,189

 

 

9,012

Total operating expenses

 

55,583

 

 

56,517

Loss from operations

 

(55,583)

 

 

(56,517)

Other income, net

 

2,911

 

 

1,328

Bargain purchase gain

 

16,355

 

 

Net loss

$

(36,317)

 

$

(55,189)

 

Pre-Merger

 

Post-

Merger

 

Pre-Merger

Per share information (1):

(a)

 

(b)

 

(c)

 

(a)

 

(b)

Net income (loss) per share, basic

$

(117.28)

 

$

 

$

27.76

 

$

(139.88)

 

$

Weighted-average shares outstanding used in computing net income (loss) per share, basic

 

426,097

 

 

 

 

491,867

 

 

394,533

 

 

Net income (loss) per share, diluted

$

(117.28)

 

$

 

$

2.93

 

$

(139.88)

 

$

Weighted-average shares outstanding used in computing net income (loss) per share, diluted

 

426,097

 

 

 

 

4,656,947

 

 

394,533

 

 

(1)

On December 18, 2023, the Company completed its reverse merger, which among other things, resulted in Neurogene OpCo merging with and into a wholly owned subsidiary of Neoleukin Therapeutics, Inc. As the earnings per share information for the pre-merger period is not comparable to the earnings per share information for the post-merger period, the earnings per share information is being presented separately for these periods. See Note 3, Net Income (Loss) Per share, for additional information.

(a)

Presents information for the pre-merger period for Class A common stock. The pre-merger period is January 1, 2023 through December 17, 2023 for the year ended December 31, 2023 and the full fiscal year ended December 31, 2022.

 

 

(b)

Presents information for the pre-merger period for Class B common stock. The pre-merger period is January 1, 2023 through December 17, 2023 for the year ended December 31, 2023 and the full fiscal year ended December 31, 2022.

 

 

(c)

Presents information for the post-merger period for common stock. The post-merger period is December 18, 2023 through December 31, 2023.

 

 

Contacts

Investor:
Melissa Forst

Argot Partners

Neurogene@argotpartners.com

Media:
David Rosen

Argot Partners

david.rosen@argotpartners.com

DNAnexus to Showcase the Power of High-Value Multi-Omics Data at the Precision Medicine in IBD Summit

DNAnexus to Showcase the Power of High-Value Multi-Omics Data at the Precision Medicine in IBD Summit




DNAnexus to Showcase the Power of High-Value Multi-Omics Data at the Precision Medicine in IBD Summit

Co-founder of Ovation to share how researchers are using DNAnexus’ Precision Health Data Cloud to streamline analysis, identify optimal therapeutic targets, and advance drug discovery

MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–#IBDDNAnexus, Inc., the provider of the Precision Health Data Cloud, today announced the speakers for its presentation at the upcoming 2nd Precision Medicine in Inflammatory Bowel Disease Summit, which is being held in Boston this week. The company is hosting a luncheon presentation that will focus on its collaboration with Ovation, an omics data company committed to accelerating the development of precision medicine, to help streamline large-scale omics data analysis.


DNAnexus’ collaboration is initially focused on Ovation’s inflammatory bowel disease omics data, which includes whole genome sequencing and RNA sequencing on normal and diseased tissues linked to longitudinal clinical data. Ovation’s omics data is derived from its extensive biobank of more than 1.6 million consented samples. These samples are sourced from a nationwide network of CLIA-certified clinical diagnostic labs serving geographically and demographically diverse populations. Ovation’s laboratory information management system is used to automatically collect, de-identify, and tokenize consented samples and to normalize aggregated data across labs. The secure and scalable DNAnexus Precision Health Data Cloud helps researchers manage, analyze, and collaborate on the complex multimodal data.

Today, DNAnexus has more than 45,000 registered users across 48 countries and actively manages and supports more than 105 petabytes of complex clinical genomic, proteomic, and other multi-omic datasets on behalf of a growing network of collaborators. Its comprehensive cloud platform meets the most rigorous industry standards for data quality, security, privacy, and regulatory compliance.

“DNAnexus is committed to building a complete ecosystem of forward-thinking multi-omic data providers like Ovation that are focused on shaping the future of drug discovery and development,” said Thomas Laur, CEO at DNAnexus. “We are looking forward to an engaging session that will not only address the acquisition and analysis of IBD omics data but also highlight its practical applications and established best practices to help advance treatment research.”

DNAnexus Hosted Luncheon

Harnessing The Power of Multi-omics to Advance IBD Drug Discovery with DNAnexus and Ovation

Wednesday, March 20, 2024; 12:30

Revere Hotel Boston Common

FEATURED PRESENTERS:

  • Barry Wark, PhD, Co-Founder and Chief Strategy Officer at Ovation
  • Nirav Amin, PhD, Director of Solutions Science at DNAnexus

To register for the conference, please visit: https://www.precision-medicine-in-ibd.com/take-part/register/.

About DNAnexus

DNAnexus enables biomedical organizations to accelerate scientific discovery and improve patient care with the Precision Health Data Cloud. The company provides scientific innovators and healthcare professionals with the ability to manage, analyze, and collaborate on multi-omic, clinical, and real-world data to unlock insights. DNAnexus actively manages more than 105 petabytes of data on behalf of a growing network of collaborations with leading pharmaceutical, clinical diagnostic, academic research, biobank, and government organizations. Today, more than 45,000 users across 48 countries and over 130 enterprise customers are harnessing the full potential of their data with the scalable and secure Precision Health Data Cloud. DNAnexus is headquartered in Mountain View, Calif. For more information, visit www.dnanexus.com or follow @DNAnexus.

Contacts

Andrew Noble

415-722-2129

andrew@bioscribe.com

Forte Biosciences, Inc. Announces 2023 Results and Provides Business Update

Forte Biosciences, Inc. Announces 2023 Results and Provides Business Update




Forte Biosciences, Inc. Announces 2023 Results and Provides Business Update

DALLAS–(BUSINESS WIRE)–Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced its 2023 results and provided a business update.

2023 Business Highlights

“Forte achieved a major milestone by advancing FB-102 into the clinic and beating the timelines we targeted in our third quarter business update. The single ascending dose (SAD) portion of the FB-102 phase 1 trial was successfully completed and dosing has begun in the multiple ascending dose (MAD) cohorts.” said Paul Wagner, Ph.D., Chairman and Chief Executive Officer of Forte Biosciences. “I am deeply appreciative of the talented Forte team that made this achievement possible. I also want to thank our investors who believe in the potential of FB-102 and in the Forte team as we continue to advance this exciting program. We look forward to providing more clinical updates on FB-102 over the course of this year.”

2023 Operating Results

Research and development expenses were $21.9 million for the year ended December 31, 2023, compared to $5.6 million during the same period in 2022. The increase of $16.3 million was primarily due to a net increase of approximately $9.9 million in manufacturing expense, a net increase of approximately $6.0 million in preclinical and clinical expenses as our FB-102 program entered the clinic, and a net increase in payroll and related expenses of approximately $0.4 million primarily due to an increase in headcount.

General and administrative expenses were $10.6 million for the year ended December 31, 2023, compared to $8.3 million for the same period in 2022. The increase of $2.3 million was primarily due to an increase in professional and legal expenses of $2.6 million, an increase in other expenses of $0.4 million, including rent and personnel expenses, partially offset by a reduction in stock-based compensation expense of $0.7 million.

Net losses per share were ($1.00) and ($0.80) for the years ended December 31, 2023 and 2022, respectively.

Forte ended 2023 with approximately $37.1 million in cash and cash equivalents. Forte had approximately 36.3 million shares of common stock outstanding as of December 31, 2023.

CONSOLIDATED BALANCE SHEETS

(in thousands except share and par value data)

 

 

 

 

 

 

 

 

December 31, 2023

 

December 31, 2022

 
Assets
Current assets:
Cash and cash equivalents

$

37,125

 

$

41,100

 

Prepaid expenses and other current assets

 

1,202

 

 

411

 

Total current assets

 

38,327

 

 

41,511

 

 
Property and equipment, net

 

109

 

 

 

Other assets

 

544

 

 

486

 

Total assets

$

38,980

 

$

41,997

 

 
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable

$

1,424

 

$

1,153

 

Accrued liabilities

 

2,242

 

 

2,026

 

Total current liabilities

 

3,666

 

 

3,179

 

 
Commitments and contingencies (Note 6)
Stockholders’ equity:
Common stock, $0.001 par value: 200,000,000 shares authorized as of
December 31, 2023 and December 31, 2022; 36,335,105 and 21,000,069 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively

 

36

 

 

21

 

Additional paid-in capital

 

153,794

 

 

125,841

 

Accumulated other comprehensive income

 

4

 

 

 

Accumulated deficit

 

(118,520

)

 

(87,044

)

Total stockholders’ equity

 

35,314

 

 

38,818

 

Total liabilities and stockholders’ equity

$

38,980

 

$

41,997

 

 

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except share and per share amounts)

 
Year Ended December 31,

 

2023

 

 

2022

 

Operating expenses:
Research and development

$

21,862

 

$

5,594

 

General and administrative

 

10,624

 

 

8,302

 

Total operating expenses

 

32,486

 

 

13,896

 

Loss from operations

 

(32,486

)

 

(13,896

)

Interest income

 

1,124

 

 

162

 

Other expense, net

 

(114

)

 

(145

)

Net loss

$

(31,476

)

$

(13,879

)

Per share information:
Net loss per share – basic and diluted

$

(1.00

)

$

(0.80

)

 
Weighted average shares and pre-funded warrants outstanding, basic and diluted

 

31,571,039

 

 

17,383,531

 

 
Comprehensive Loss:
Net loss

$

(31,476

)

$

(13,879

)

Unrealized gain on available-for-sale securities

 

4

 

 

 

Comprehensive loss

$

(31,472

)

$

(13,879

)

 

Additional details on our 2023 financial results can be found in Forte’s Form 10-K as filed with the SEC on March 18, 2024. You can also find more information in the investor relations section of our website at www.fortebiorx.com.

About Forte

Forte Biosciences, Inc. is a clinical-stage biopharmaceutical company that is advancing its product candidate, FB-102, which is a proprietary molecule with potentially broad autoimmune and autoimmune-related applications including in such indications as graft-versus-host disease, vitiligo and alopecia areata.

Forward-Looking Statements

Forte cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the Company’s current beliefs and expectations. Forward looking statements include statements regarding the Company’s beliefs, goals, intentions and expectations regarding its product candidate, FB-102 and the therapeutic potential of FB-102. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: risks related to Forte’s ability to obtain sufficient additional capital to continue to advance Forte’s product candidate, FB-102; uncertainties associated with the clinical development and regulatory approval of Forte’s product candidate, FB-102, including potential delays in the commencement, enrollment and completion of clinical trials; the risk that results from preclinical studies may not be predictive of results from clinical trials; risks associated with the failure to realize any value from FB-102 in light of inherent risks and difficulties involved in successfully bringing product candidates to market; and additional risks, uncertainties, and other information affecting Forte’s business and operating results is contained in Forte’s Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission on March 18, 2024, and in its other filings with the Securities and Exchange Commission. All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Forte undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Source: Forte Biosciences, Inc.

Contacts

LifeSci Advisors

Mike Moyer, Managing Director

mmoyer@lifesciadvisors.com

Forte Biosciences, Inc.

Paul Wagner, CEO

investors@fortebiorx.com

Alpine Immune Sciences Provides Corporate Update and Full Year 2023 Financial Results

Alpine Immune Sciences Provides Corporate Update and Full Year 2023 Financial Results




Alpine Immune Sciences Provides Corporate Update and Full Year 2023 Financial Results

— Clinical data on povetacicept in IgA nephropathy will be updated at the upcoming WCN meeting, including follow up at 80 mg and initial data at 240 mg SC once every four-weeks —

— Povetacicept advancing towards a pivotal phase 3 trial in IgA nephropathy and a phase 2 trial in systemic lupus erythematosus —

SEATTLE–(BUSINESS WIRE)–Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today reported full year 2023 financial results and company highlights for the fourth quarter ended December 31, 2023.


2023 was a transformational year for Alpine, with initial IgA nephropathy (IgAN) data presented at the American Society of Nephrology Kidney Week 2023 suggesting a best-in-class profile for povetacicept, our next-generation dual BAFF/APRIL inhibitor. With our encouraging data set in IgAN, convenient once monthly dosing regimen, and strong balance sheet, we are rapidly advancing development of povetacicept as a potentially meaningful new therapeutic option for patients living with IgAN, systemic lupus erythematosus (SLE), and multiple other autoantibody-related diseases,” said Mitchell H. Gold, MD, Executive Chairman and Chief Executive Officer of Alpine.

Dr. Gold continued, “Looking ahead, Alpine is well positioned for a year of meaningful catalysts, with multiple updates for povetacicept in IgAN and other indications, and the planned initiation of RAINIER, a pivotal phase 3 study of povetacicept in IgAN, and DENALI, a phase 2 study of povetacicept in SLE. In addition to updates on our clinical studies, we look forward to sharing translational data that further supports the best-in-class potential of povetacicept in multiple inflammatory diseases.”

Fourth Quarter 2023 Corporate Updates

Povetacicept (ALPN-303)

  • First clinical data in IgAN demonstrate that povetacicept 80 mg administered once every four-weeks (Q4W) reduced proteinuria (as assessed by urine protein to creatinine ratio, UPCR) by greater than 50% and was associated with stable renal function (as assessed by estimated glomerular filtration rate, eGFR) at six months. In addition, povetacicept was well tolerated during subcutaneous administration, with no instances of IgG < 3 g/L, and no severe infections (2023 American Society of Nephrology Kidney Week).
  • In a model of murine experimental autoimmune myasthenia gravis, povetacicept improved disease activity, with clinical scores superior to treatment with either the FcRn inhibitor efgartigimod or an anti-CD20 depleting antibody (2023 American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting).
  • New translational data from povetacicept in systemic lupus erythematosus demonstrate that povetacicept, as compared to single BAFF or APRIL pathway inhibitors, more potently downregulates genes associated with activation in B cells and significantly reduces multiple disease parameters in a mouse model of lupus, more effectively than WT TACI-Fc or conventional B cell depletion (2023 American College of Rheumatology Convergence).
  • Throughout 2023, the Company presented multiple oral and poster presentations on povetacicept at scientific conferences (Full List of Company Publications and Presentations).

Corporate Updates

  • The Company plans to present additional data on povetacicept in IgA nephropathy, including follow up data from the 80 mg Q4W and initial data from the IgAN 240 mg Q4W dose cohorts, during a Late Breaking Abstract session at the World Congress of Nephrology 2024 on Monday April 15th at 4:45 PM ET.
  • The Company plans to present new preclinical data on povetacicept, demonstrating its greater distribution to disease-related end organs compared with WT TACI-Ig, at the 14th European Lupus Meeting. These findings correlate with povetacicept’s improved efficacy in multiple preclinical disease models.
  • The Company intends to initiate RAINIER, a pivotal phase 3 study of povetacicept in IgA nephropathy and DENALI, a phase 2 study of povetacicept in systemic lupus erythematosus in the second half of 2024, pending regulatory agreement.
  • The Company plans to share initial data from RUBY-4 in autoimmune cytopenias in the first half of 2024 at a relevant scientific congress.
  • The Company amended its option and license agreement on acazicolcept with AbbVie, stopping enrollment in the phase 2 study in systemic lupus erythematosus (Synergy), and facilitating early assessment of data.
  • The Company ended the year with $368.2 million in cash and investments as of December 31, 2023, which the Company anticipates should be sufficient to fund its planned operations into 2026.

2023 Financial Results

Cash Position and Runway: As of December 31, 2023, Alpine’s cash and investments totaled $368.2 million compared to $273.4 million as of December 31, 2022. The Company anticipates its current cash and investments are sufficient to fund planned operations into 2026.

Collaboration Revenue: For the year ended December 31, 2023, collaboration revenue was $58.9 million compared to $30.1 million for the same period in 2022. The increase in collaboration revenue relates primarily to a $24.9 million increase in AbbVie revenue, of which $20.4 million relates to a cumulative catch-up adjustment resulting from the completion of enrollment in Synergy per the amendment with AbbVie, and a $4.5 million increase in Amgen revenue, driven primarily by the expiration of Amgen’s option to select a third Research Program. These increases were partially offset by a $0.6 million decrease in Adaptimmune revenue as we completed our final deliverables under the agreement in June 2023.

Research and Development Expense: For the year ended December 31, 2023, research and development expense, inclusive of non-cash expenses, were $80.9 million compared to $70.2 million for the same period in 2022. The increase of $10.7 million was driven by an $8.2 million increase in povetacicept costs, primarily related to higher clinical trial costs, process development, and manufacturing, a $1.3 million increase in acazicolcept costs, due primarily to process development and manufacturing costs, and a $7.7 million increase in personnel costs.

General and Administrative Expenses: For the year ended December 31, 2023, general and administrative expenses, inclusive of non-cash expenses, were $22.2 million compared to $18.0 million for the same period in 2022. The increase of $4.3 million was primarily attributable to increases in personnel costs and professional services.

Net Loss: Net loss for the year ended December 31, 2023, was $32.2 million compared to $57.8 million for the same period in 2022.

Alpine Immune Sciences, Inc.

 

 

 

 

Selected Consolidated Balance Sheet Data

 

 

 

 

(In thousands)

 

December 31, 2023

 

December 31, 2022

 

 

(unaudited)

Cash and cash equivalents

 

$

43,921

 

$

13,376

Short-term investments

 

 

283,491

 

 

224,265

Total current assets

 

 

330,034

 

 

240,993

Long-term investments

 

 

40,556

 

 

35,481

Total assets

 

 

379,852

 

 

286,686

Total current liabilities

 

 

41,980

 

 

57,996

Total stockholders’ equity

 

 

327,941

 

 

179,420

Total liabilities and stockholders’ equity

 

 

379,852

 

 

286,686

Consolidated Statement of Operations and Comprehensive Income (Loss) Data

 

 

 

 

(In thousands, except share and per share amounts)

 

Years Ended December 31,

 

 

2023

 

2022

 

 

(unaudited)

Collaboration revenue

 

$

58,876

 

 

$

30,064

 

Operating expenses:

 

 

 

 

Research and development

 

 

80,904

 

 

 

70,243

 

General and administrative

 

 

22,222

 

 

 

17,968

 

Total operating expenses

 

 

103,126

 

 

 

88,211

 

Loss from operations

 

 

(44,250

)

 

 

(58,147

)

Other income (expense):

 

 

 

 

Interest income

 

 

11,852

 

 

 

3,288

 

Interest expense

 

 

(98

)

 

 

(476

)

Other, net

 

 

415

 

 

 

(97

)

Loss before taxes

 

 

(32,081

)

 

 

(55,432

)

Income tax (expense) benefit

 

 

(103

)

 

 

(2,330

)

Net loss

 

$

(32,184

)

 

$

(57,762

)

Comprehensive income (loss):

 

 

 

 

Unrealized gain (loss) on investments

 

 

1,493

 

 

 

(901

)

Unrealized gain (loss) on foreign currency translation

 

 

25

 

 

 

53

 

Comprehensive loss

 

$

(30,666

)

 

$

(58,610

)

Weighted-average shares used to compute basic and diluted net loss per share

 

 

50,000,339

 

 

 

33,435,280

 

Basic and diluted net loss per share

 

$

(0.64

)

 

$

(1.73

)

About Povetacicept (ALPN-303)

Povetacicept (ALPN-303) is a dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines, which play key roles in pathogenesis of multiple autoimmune diseases via their roles in the activation, differentiation and/or survival of B cells, particularly antibody-secreting cells, as well as T cells and innate immune cells. Based upon an engineered TACI (transmembrane activator and CAML interactor) domain, povetacicept has exhibited greater potency in preclinical studies versus other inhibitors of BAFF and/or APRIL alone and B cell depletion. Povetacicept is in development for multiple autoimmune diseases, including IgA nephropathy and other autoimmune kidney diseases, systemic lupus erythematosus, and autoimmune cytopenias.

About RUBY-3

RUBY-3 (NCT05732402) is a multiple ascending dose, multi-cohort, open label, phase 1b/2a study of povetacicept in autoimmune glomerulonephritis, including IgA nephropathy, primary membranous nephropathy, lupus nephritis, and renal ANCA-associated vasculitis, where povetacicept is being administered subcutaneously for up to 104 weeks. Key endpoints include proteinuria, eGFR, renal response, and disease-related autoantibodies.

About RUBY-4

RUBY-4 (NCT05757570) is a multi-cohort, open label, phase 1b study of povetacicept in immune thrombocytopenia, autoimmune hemolytic anemia, and cold agglutinin disease, where povetacicept is being administered subcutaneously for up to 48 weeks. Key endpoints include respective blood cell counts, including durable responses, as well as disease-related autoantibodies.

About Alpine Immune Sciences

Alpine Immune Sciences is committed to leading a new wave of immune therapeutics. With world-class research and development capabilities, a highly productive scientific platform, and a proven management team, Alpine is seeking to create first- or best-in-class multifunctional immunotherapies via unique protein engineering technologies to improve patients’ lives. Alpine has entered into strategic collaborations with leading global biopharmaceutical companies and has a diverse pipeline of clinical and preclinical candidates in development. For more information, visit www.alpineimmunesciences.com. Follow @AlpineImmuneSci on X and LinkedIn.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies; the timing of and results from clinical trials and preclinical development activities; clinical and regulatory objectives and the timing thereof; expectations regarding the sufficiency of cash, including cash equivalents and restricted cash, and investments to fund our planned operations into 2026; our ability to achieve additional milestones in our collaborations and proprietary programs; the progress and potential of our development programs; future development plans and clinical and regulatory milestones and objectives, including the timing and achievement thereof; the efficacy of our clinical trial designs; anticipated enrollment in our clinical trials and the timing thereof; expectations regarding the anticipated reporting of data from our ongoing and planned clinical trials and potential publication of future clinical data; our ability to potentially advance povetacicept directly into a pivotal trial in the second half of 2024 as well as a phase 2 study in systemic lupus erythematosus, pending engagement with and approval of the Food and Drug Administration; and the potential efficacy, safety profile, addressable market, regulatory success and commercial or therapeutic potential of our product candidates. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “intend,” and other similar expressions, among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our product candidates; our ongoing discovery and preclinical efforts may not yield additional product candidates; our discovery stage and preclinical programs may not advance into the clinic or result in approved products; any of our product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of competition; adverse conditions in the general domestic and global economic markets; we may be unable to advance povetacicept directly into a pivotal trial or a phase 2 study in systemic lupus erythematosus in the second half of 2024; the impact of pandemics, or other related health crises on our business, research and clinical development plans and timelines and results of operations, including the impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we undertake no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements. The RUBY and Alpine logos are registered trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.

Contacts

Investor and Media Contact:
Alpine Immune Sciences, Inc.

ir@alpineimmunesciences.com
media@alpineimmunesciences.com

PURE Bioscience Reports Fiscal Second Quarter 2024 Financial Results

PURE Bioscience Reports Fiscal Second Quarter 2024 Financial Results




PURE Bioscience Reports Fiscal Second Quarter 2024 Financial Results

Update on Business and PURE’s SDC-Based Antimicrobial Food Safety Solutions

EL CAJON, Calif.–(BUSINESS WIRE)–PURE Bioscience, Inc. (OTCQB: PURE) (“PURE,” the “Company” or “we”), creator of the patented non-toxic silver dihydrogen citrate (SDC) antimicrobial, today reported financial results for the fiscal second quarter ended January 31, 2024.


Summary of Results – Fiscal Second Quarter Operations

  • Net product sales were $325,000 and $396,000 for the fiscal second quarter ended January 31, 2024 and 2023, respectively. The decrease of $71,000 was attributable to decreased sales across our end user network.
  • Net loss for the fiscal second quarter ended January 31, 2024 was $1,002,000, compared to $1,060,000 for the fiscal second quarter ended January 31, 2023.
  • Net loss, excluding share-based compensation, for the fiscal second quarter ended January 31, 2024 was $938,000, compared to $993,000 for the fiscal second quarter ended January 31, 2023.
  • Net loss per share was ($0.01) for the fiscal second quarters ended January 31, 2024 and 2023, respectively.

Six Months: Summary of Results of Operations

  • Net product sales were $1,043,000 and $863,000 for the six months ended January 31, 2024 and 2023, respectively. The increase of $180,000 was attributable to increased sales across our end user and distribution network.
  • Net loss for the six months ended January 31, 2024 was $1,737,000, compared to $2,053,000 for the six months ended January 31, 2023.
  • Net loss, excluding share-based compensation, for the six months ended January 31, 2024 was $1,593,000, compared to $1,842,000 for the six months ended January 31, 2023.
  • Net loss per share was ($0.02) for the six months ended January 31, 2024 and 2023, respectively.

Robert Bartlett, Chief Executive Officer, said, “Our fiscal second quarter revenue was very disappointing at best. While historically, this quarter is our lowest revenue generator, FYQ2 experienced an unexpected interruption in the flow of PURE products to one of our major customers. The impact of this interruption cannot be overstated. We anticipate this shortfall in revenue will be absorbed in future sales.”

Business Update

We are excited to announce that we are beginning to make headway into new food segments as we work on expanding our footprint in the food industry.

  • Brand Advertising and Marketing. Having a social media presence has been a focus of the newly-formed marketing committee at PURE. Our recently updated website is a helpful sales tool for lead generation, as well as a central location for customer support and questions. PURE will continue to evolve its brand as we work with a new branding firm to guide us in clearly communicating to the public that PURE’s team and chemistry are trustworthy, offering premium products that represent a complete game changer in the world of food safety and sanitization. Our targeted end user is committed to protecting their customers, employees, the environment, as well as their own brand name.

  • Trade Shows. Attending and supporting customer events and trade shows has been and will continue to be a significant part of our growth initiatives. This has proven to be an effective approach to meeting new customers and continue networking and educating the industry on our unique SDC solutions. At the end of FYQ2, PURE attended the global International Production & Processing Expo (IPPE) show for the first time. Our team was able to better understand current industry trends and solutions, as well as network and meet with key customers. In addition, the team was able to facilitate strategic meetings with key industry leaders from North America and across the globe. PURE is again registered to exhibit at the International Association for Food Protection (IAFP) annual meeting in Long Beach, California (July 14-17, 2024). The IAFP annual meeting is attended by more than 3,500 of the top industry, academic and governmental food safety professionals.

  • Distributor Focus and Support. Our business strategy will be shifting focus from a direct sales model to a distributor model. This model provides a much needed expansion of coverage in all regions of the United States. With local boots on the ground, our distributors allow PURE to expand our footprint into new market segments and customer bases as we are integrated into our distribution partners’ chemical portfolios and solution offerings. Due to the unique nature of our SDC molecule and ongoing advancement in application technologies, our distributors will be able to present their customers innovative solutions previously unavailable to them. This transition facilitates:

    • Broader coverage of service personnel and more regular on-site visits to customers;
    • Strengthening and growing partnerships with current distributors;
    • Bringing on new key distributors;
    • Leveraging the PURE team to provide enhanced support from remote to on-site visits;
    • Better market penetration of our brand and product awareness;
    • Acceleration of our sales model; and
    • Expedited access to new market segments.

  • Continued Innovation. The development of new solutions through application equipment is a large part of our current R&D efforts. New business sectors, including the dairy industry and the animal health market, have shown promising interest as we begin to explore the use of our SDC technology. Incorporating technology into our equipment solutions is another avenue through which we are enhancing our ability to support our customers’ greatest needs in food safety.

Tim Steffensmeier, Vice President of Sales, said, “The technical sales team we have assembled has nearly 100 years of combined food and chemical industry experience. The varying experience and unique skillsets enables our team to be productive in business development, sales and marketing, new equipment solutions, and new product development and microbiology solutions. Our team is dedicated to prioritizing the sustainability of the Company’s growth, and are actively cultivating new relationships with key stakeholders while also nurturing and expanding current key industry and distributor accounts.”

About PURE Bioscience, Inc.

PURE is focused on developing and commercializing our proprietary antimicrobial products primarily in the food safety arena. We provide solutions to combat the health and environmental challenges of pathogen and hygienic control. Our technology platform is based on patented, stabilized ionic silver, and our initial products contain silver dihydrogen citrate, better known as SDC. This is a broad-spectrum, non-toxic antimicrobial agent, and formulates well with other compounds. As a platform technology, SDC is distinguished from existing products in the marketplace because of its superior efficacy, reduced toxicity and mitigation of bacterial resistance. PURE’s mailing address of 771 Jamacha Rd. #512, El Cajon, California 92019 (San Diego County area) serves as its official address for all business requirements. Additional information on PURE is available at www.purebio.com.

Forward-looking Statements: Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Statements in this press release, including quotes from management, concerning the Company’s expectations, plans, business outlook, future performance, future potential revenues, expected results of the Company’s marketing efforts, the execution of contracts under negotiation and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements.” Forward-looking statements inherently involve risks and uncertainties that could cause our actual results to differ materially from any forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s failure to implement or otherwise achieve the benefits of its proposed business initiatives and plans; acceptance of the Company’s current and future products and services in the marketplace, including the Company’s ability to convert successful evaluations and tests for PURE Control and PURE Hard Surface into customer orders and customers continuing to place product orders as expected and to expand their use of the Company’s products; the Company’s ability to maintain relationships with its partners and other counterparties; the Company’s ability to generate sufficient revenues and reduce its operating expenses in order to reach profitability; the Company’s ability to raise the funding required to support its continued operations and the implementation of its business plan; the ability of the Company to develop effective new products and receive required regulatory approvals for such products, including the required data and regulatory approvals required to use its SDC-based technology as a direct food contact processing aid in raw meat processing and to expand its use in OLR poultry processing; competitive factors, including customer acceptance of the Company’s SDC-based products that are typically more expensive than existing treatment chemicals; dependence upon third-party vendors, including to manufacture its products; and other risks detailed in the Company’s periodic report filings with the Securities and Exchange Commission (the SEC), including its Form 10-K for the fiscal year ended July 31, 2023, Form 10-Q for the fiscal first quarter ended October 31, 2023, and Form 10-Q for the fiscal second quarter ended January 31, 2024. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release.

PURE Bioscience, Inc.

Condensed Consolidated Balance Sheets

 

 

 

January 31, 2024

 

 

July 31, 2023

 

 

 

(Unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

557,000

 

 

$

1,095,000

 

Accounts receivable

 

 

171,000

 

 

 

285,000

 

Inventories, net

 

 

74,000

 

 

 

88,000

 

Restricted cash

 

 

75,000

 

 

 

75,000

 

Prepaid expenses

 

 

62,000

 

 

 

61,000

 

Total current assets

 

 

939,000

 

 

 

1,604,000

 

Property, plant and equipment, net

 

 

147,000

 

 

 

221,000

 

Total assets

 

$

1,086,000

 

 

$

1,825,000

 

Liabilities and stockholders’ equity (deficiency)

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

$

409,000

 

 

$

422,000

 

Accrued liabilities

 

 

136,000

 

 

 

110,000

 

Total current liabilities

 

 

545,000

 

 

 

532,000

 

Long-term liabilities

 

 

 

 

 

 

 

 

Note payable to related parties

 

 

1,862,000

 

 

 

1,021,000

 

Total long-term liabilities

 

 

1,862,000

 

 

 

1,021,000

 

Total liabilities

 

 

2,407,000

 

 

 

1,553,000

 

Commitments and contingencies

 

 

 

 

 

 

Stockholders’ equity (deficiency)

 

 

 

 

 

 

 

 

Preferred stock, $0.01 par value: 5,000,000 shares authorized, no shares issued and outstanding

 

 

 

 

 

 

Common stock, $0.01 par value: 150,000,000 shares authorized, 111,856,473 shares issued and outstanding at January 31, 2024, and July 31, 2023

 

 

1,119,000

 

 

 

1,119,000

 

Additional paid-in capital

 

 

132,542,000

 

 

 

132,398,000

 

Accumulated deficit

 

 

(134,982,000

)

 

 

(133,245,000

)

Total stockholders’ equity (deficiency)

 

 

(1,321,000

)

 

 

272,000

 

Total liabilities and stockholders’ equity (deficiency)

 

$

1,086,000

 

 

$

1,825,000

 

PURE Bioscience, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

 

Six Months Ended

 

 

Three months Ended

 

 

 

January 31,

 

 

January 31,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Net product sales

 

$

1,043,000

 

 

$

863,000

 

 

$

325,000

 

 

$

396,000

 

Royalty revenue

 

 

5,000

 

 

 

5,000

 

 

 

1,000

 

 

 

1,000

 

Total revenue

 

 

1,048,000

 

 

 

868,000

 

 

 

326,000

 

 

 

397,000

 

Cost of goods sold

 

 

429,000

 

 

 

414,000

 

 

 

149,000

 

 

 

200,000

 

Gross profit

 

 

619,000

 

 

 

454,000

 

 

 

177,000

 

 

 

197,000

 

Operating costs and expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

 

2,138,000

 

 

 

2,345,000

 

 

 

1,065,000

 

 

 

1,180,000

 

Research and development

 

 

156,000

 

 

 

153,000

 

 

 

76,000

 

 

 

75,000

 

Total operating costs and expenses

 

 

2,294,000

 

 

 

2,498,000

 

 

 

1,141,000

 

 

 

1,255,000

 

Loss from operations

 

 

(1,675,000

)

 

 

(2,044,000

)

 

 

(964,000

)

 

 

(1,058,000

)

Other income (expense)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense), net

 

 

 

 

 

(5,000

)

 

 

 

 

 

 

Interest expense, net

 

 

(62,000

)

 

 

(4,000

)

 

 

(38,000

)

 

 

(2,000

)

Total other income (expense)

 

 

(62,000

)

 

 

(9,000

)

 

 

(38,000

)

 

 

(2,000

)

Net loss

 

$

(1,737,000

)

 

$

(2,053,000

)

 

$

(1,002,000

)

 

$

(1,060,000

)

Basic and diluted net loss per share

 

$

(0.02

)

 

$

(0.02

)

 

$

(0.01

)

 

$

(0.01

)

Shares used in computing basic and diluted net loss per share

 

 

111,856,473

 

 

 

111,356,473

 

 

 

111,856,473

 

 

 

111,356,473

 

PURE Bioscience, Inc.

Condensed Consolidated Statement of Stockholders’ Equity (Deficiency)

(Unaudited)

 

 

 

Six Months Ended January 31, 2024

 

 

Six Months Ended January 31, 2023

 

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Accumulated

 

 

Total

Stockholders’

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Accumulated

 

 

Total

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Equity

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances at beginning of period

 

 

111,856,473

 

 

$

1,119,000

 

 

$

132,398,000

 

 

$

(133,245,000

)

 

$

272,000

 

 

 

111,356,473

 

 

$

1,114,000

 

 

$

132,079,000

 

 

$

(129,284,000

)

 

$

3,909,000

 

Share-based compensation expense – stock options

 

 

 

 

 

 

 

 

144,000

 

 

 

 

 

 

144,000

 

 

 

 

 

 

 

 

 

169,000

 

 

 

 

 

 

169,000

 

Share-based compensation expense – restricted stock units

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

42,000

 

 

 

 

 

 

42,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(1,737,000

)

 

 

(1,737,000

)

 

 

 

 

 

 

 

 

 

 

 

(2,053,000

)

 

 

(2,053,000

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances at end of period (Unaudited)

 

 

111,856,473

 

 

$

1,119,000

 

 

$

132,542,000

 

 

$

(134,982,000

)

 

$

(1,321,000

)

 

 

111,356,473

 

 

$

1,114,000

 

 

$

132,290,000

 

 

$

(131,337,000

)

 

$

2,067,000

 

 

 

Three Months Ended January 31, 2024

 

 

Three Months Ended January 31, 2023

 

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Accumulated

 

 

Total

Stockholders’

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Accumulated

 

 

Total

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Equity

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances at beginning of period (Unaudited)

 

 

111,856,473

 

 

$

1,119,000

 

 

$

132,478,000

 

 

$

(133,980,000

)

 

$

(383,000

)

 

 

111,356,473

 

 

$

1,114,000

 

 

$

132,163,000

 

 

$

(130,277,000

)

 

$

3,000,000

 

Balance

111,856,473

$

1,119,000

$

132,478,000

$

(133,980,000

)

$

(383,000

)

111,356,473

$

1,114,000

$

132,163,000

$

(130,277,000

)

$

3,000,000

Share-based compensation expense – stock options

 

 

 

 

 

 

 

 

64,000

 

 

 

 

 

 

64,000

 

 

 

 

 

 

 

 

 

106,000

 

 

 

 

 

 

106,000

 

Share-based compensation expense – restricted stock units

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

21,000

 

 

 

 

 

 

21,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(1,002,000

)

 

 

(1,002,000

)

 

 

 

 

 

 

 

 

 

 

 

(1,060,000

)

 

 

(1,060,000

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances at end of period (Unaudited)

 

 

111,856,473

 

 

$

1,119,000

 

 

$

132,542,000

 

 

$

(134,982,000

)

 

$

(1,321,000

)

 

 

111,356,473

 

 

$

1,114,000

 

 

$

132,290,000

 

 

$

(131,337,000

)

 

$

2,067,000

 

PURE Bioscience, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

 

 

2024

 

 

2023

 

 

 

Six Months Ended

 

 

 

January 31,

 

 

 

2024

 

 

2023

 

Operating activities

 

 

 

 

 

 

 

 

Net loss

 

$

(1,737,000

)

 

$

(2,053,000

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Share-based compensation

 

 

144,000

 

 

 

211,000

 

Depreciation and amortization

 

 

74,000

 

 

 

67,000

 

Gain on extinguishment of indebtedness

 

 

 

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

114,000

 

 

 

45,000

 

Inventories

 

 

14,000

 

 

 

(21,000

)

Prepaid expenses

 

 

(1,000

)

 

 

(6,000

)

Interest on note payable

 

 

56,000

 

 

 

 

Accounts payable and accrued liabilities

 

 

13,000

 

 

 

(112,000

)

Net cash used in operating activities

 

 

(1,323,000

)

 

 

(1,869,000

)

Investing activities

 

 

 

 

 

 

 

 

Purchases of property, plant and equipment

 

 

 

 

 

(37,000

)

Net cash used in investing activities

 

 

 

 

 

(37,000

)

Financing activities

 

 

 

 

 

 

 

 

Net proceeds from note payable to related parties

 

 

785,000

 

 

 

 

Net cash provided by financing activities

 

 

785,000

 

 

 

 

Net decrease in cash, cash equivalents, and restricted cash

 

 

(538,000

)

 

 

(1,906,000

)

Cash, cash equivalents, and restricted cash at beginning of period

 

 

1,170,000

 

 

 

3,466,000

 

Cash, cash equivalents, and restricted cash at end of period

 

$

632,000

 

 

$

1,560,000

 

 

 

 

 

 

 

 

 

 

Reconciliation of cash, cash equivalents, and restricted cash to the condensed consolidated balance sheets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

557,000

 

 

$

1,485,000

 

Restricted cash

 

$

75,000

 

 

$

75,000

 

Total cash, cash equivalents and restricted cash

 

$

632,000

 

 

$

1,560,000

 

 

 

 

 

 

 

 

 

 

Supplemental disclosure of cash flow information

 

 

 

 

 

 

 

 

Cash paid for taxes

 

$

 

 

 

5,000

 

 

Contacts

Mark Elliott, VP Finance

PURE Bioscience, Inc.

Phone: 619-596-8600 ext.: 116

Immunis Chairman Dr. Hans Keirstead to Present Abundance360 Moonshot

Immunis Chairman Dr. Hans Keirstead to Present Abundance360 Moonshot




Immunis Chairman Dr. Hans Keirstead to Present Abundance360 Moonshot

IRVINE, Calif.–(BUSINESS WIRE)–#ClinicalTrialsImmunis, Inc., a private biotech company developing an innovative secretome for age-related diseases and immune dysfunction, announces that its Chairman, Dr. Hans Keirstead, will present at the annual Abundance360 in Los Angeles. Dr. Peter Diamandis is the world-renown entrepreneur and mastermind behind Abundance360, which fosters collaboration between prominent figures in space, technology, education, venture capital and longevity research.


In the past decade, longevity research has emerged as one of science’s most popular areas of study. In fact, Abundance360 showcases “Moonshots,” or transformative ideas, from leaders who are making excellent strides to revolutionize human healthspan. Dr. Keirstead’s Moonshot aims for the incredible goal of one day treating 500M individuals with Immunis’ investigational secretome (IMMUNA) to combat age-related immune dysfunction, targeting muscle atrophy and metabolic decline.

100% of humans develop sarcopenia with age, which significantly impairs mobility and compromises quality of life. There are no FDA-approved treatments to attenuate muscle loss and/or improve muscle regeneration. Published pre-clinical studies in aged mouse models show that IMMUNA improves muscle mass, strength, and function (Fix, et al. GeroScience, 2021). IMMUNA also increases whole-body lean mass and reduces fat mass in correlation with the observed increase in muscle fiber area (data approved for publication in Aging Cell, 2024).

Immunis’ Phase 1/2a clinical trial is determining the safety, tolerability and efficacy of its novel immunomodulatory secretome in elderly patients with muscle atrophy, and the preliminary data are highly promising. IMMUNA may be the first treatment in the world to successfully address sarcopenia. Dr. Keirstead’s Moonshot with IMMUNA aligns perfectly with his “Massive Transformative Purpose” to democratize regenerative medicine and enable everyone to live healthier lives.

About Abundance360

Abundance360 carefully curates its material for groups of like-minded individuals who seek to motivate and empower one another to change the world.

About Immunis Inc.

Immunis is a private biotechnology company developing a novel immunomodulatory secretome product for the various manifestations of age and disease-related immune decline. The investigational product line leverages Immunis’ leading-edge capabilities in secretome technology to deliver a product of all natural, all human immune modulators in their natural relative physiological concentrations. For additional information about Immunis’ Phase 1/2a clinical trial please visit: https://immunisbiomedical.com/clinical-trials/

Cautionary Note Regarding Forward-Looking Statements

This communication contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as applicable. Forward-looking statements include, but are not limited to, statements regarding our plans, beliefs, expectations and assumptions, as well as other statements that are not necessarily historical facts. You are cautioned that these forward-looking statements are only predictions and involve risks and uncertainties. Further, any forward-looking statement speaks only as of the date as of which it is made, and we do not intend to update or revise any forward-looking statements. This communication also contains market data related to our business and industry which includes projections that are based on several assumptions we believe are reasonable and most significant to the projections as of the date of this communication. If any of our assumptions prove to be incorrect, our actual results may significantly differ from our projections based on these assumptions. This communication is neither an offer to sell nor a solicitation of an offer to buy any of the securities described herein.

Contacts

contact@immunisbiomedical.com