About Us | ScientistKRBP Kiromic BioPharma Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
KB-ISM (ALEXIS-ISO-1)
Solid tumors
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Phase 1
Phase 1
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Phase 1 dosing to commence 3Q 2021
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Latest News
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Kiromic Biopharma, Inc. (NASDAQ:KRBP), a pioneer in immuno oncology cellular therapy in solid tumors, is pleased to announce it has completed the acquisition of InSilico Solutions.
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http://bioinformatics.mdanderson.org/main/SpliceSeq:Overview (Graphic: Business Wire)">SpliceSeq, http://bioinformatics.mdanderson.org/main/SpliceSeq:Overview (Graphic: Business Wire)
InSilico Solutions is a world-class bio-informatics and artificial intelligence innovator with a long standing collaborative relationship with its clients at MD Anderson Cancer Center, Johns Hopkins School of Medicine, and the National Cancer Institute.
With this acquisition, Kiromic will bring in-house a team of experts in bioinformatics and AI in order to lengthen its lead in the race for an AI technology with the capability to select the optimal bio-markers needed for cutting edge immunotherapeutics such as CAR-T cell therapy.
Many CAR-T developers are still developing their CAR-T with biomarkers from decade old target libraries with known poor clinical outcomes.
Chief Executive Officer of Kiromic, Maurizio Chiriva-Internati, DBSc, PhDs, commented
We are pleased to have officially closed this long awaited acquisition of InSilico Solutions.
The InSilico Solutions is another testament to our commitment to developing the very best possible CAR-T. And the very best CAR-T will start with having the best possible bio-markers by employing cutting edge bio-informatics and AI technologies.
Our CAR-T will be outpatient, off-the-shelf allogeneic.
The amount of information that oncologists and scientists gather from cancer patients continues to grow exponentially.
The number of scientists and the time those scientists have to analyze those billions of data point have not grown exponentially.
It makes sense that bioinformatics and artificial intelligence are brought to bear on the tasks of going through the mountains of data to select biomarkers in a few hours which would have required decades of human labor to do.
Best bio-informatics and AI.
Better biomarkers.
Better Manufacturing.
Better CAR-Ts.
Better Clinical Outcomes.
Chief of BioInformatics and Research Computing Officer, Michael Ryan, PhD commented :
Over the past 3 years we have had an amazingly productive collaboration with Kiromic.
Together we produced a highly effective system that allows Kiromic to identify the needles in the haystack of genomic data – small sections of protein that are specific to the surface of cancer cells and that can be targeted by immunotherapy.
The entire InSilico staff is extremely energized by the acquisition by Kiromic.
We believe we can have an immediate, significant impact on accelerating delivery of effective treatment to patients.
Our next focus will be on utilizing AI methods to optimize response to allogeneic T cell therapy.
In particular, we are developing models using WGS, RNASeq, scRNASeq, cytrometry, and cytokine panels to assist in selecting donor T cells with the strongest therapeutic potential.
Similar data from clinical trials will be used refine our understanding of efficacy and toxicity to improve treatment protocol and patient selection.
We will continually evaluate, implement, and improve our industry leading systems that will accelerate therapeutic development, manufacturing, and clinical testing of Kiromic's off-the-shelf allogeneic CAR-T for solid tumors.
Chief Medical Officer of Kiromic, Scott Dahlbeck, MD commented:
World-wide, patients with advanced cancer conditions are in great need of effective treatment solutions that can be added to the clinical armamentarium of medical providers.
However, in order to achieve significant gains in patient survival, innovative discoveries in biomarker discovery, selection, and validation are critical to facilitate the development of the next generation of immunotherapeutics that can truly make a difference.
The acquisition of InSilico Solutions is a major step forward in this process, and we are looking forward to the breakthroughs that will result from this expansion of Kiromic's AI capabilities and subsequently its CAR-T.
Chief of Strategy and Innovation Officer, Mr. Gianluca Rotino commented:
The acquisition of InSilico will allow significant advancement in the use of computational technologies throughout the development process, from discovery to manufacturing and in clinical trials.
This places Kiromic among the pioneers in innovative cell therapy and makes the upcoming clinical trial a critical milestone not only for the company, but for all the Cell Therapy Space.
Under the agreement terms, Kiromic acquires InSIlico through a stock-swap operation, hiring the entire staff of InSIlico and their material and immaterial assets.
The deal was followed up by the Strategy and Corporate Development department of Kiromic Biopharma
BEVILACQUA LLP served as Legal Counsel.
ThinkEquity served as financial advisors. ThinkEquity, a division of Fordham Financial Management, Inc.
Chief Financial Officer, Mr. Tony Tontat commented:
InSilico Solutions was a great find for the company 3 years ago when the collaboration started.
It's an even better find today with the closing of this acquisition.
InSilico in-house will mean that our bio-informatics department will have the continuous attention of developers as new developments evolve.
The InSilico acquisition will not impact the company's cash runway post the recent follow-on financing which closed on July 2021.
About InSilico Solutions
Overview
InSilico Solutions is a bioinformatics company with a stellar 10-year track record of developing innovative software for cancer researchers.
InSilico staff includes an even mix if PhD scientists and senior engineers who specialize in building applications for analysis of diverse, large-scale genomics data.
InSilico's skills in machine learning, modeling, visualization, and intuitive interface design allows them to present complex data to researchers in an interpretable fashion, laying the groundwork for faster and more thorough discovery.
InSilico's Tools
http://insilico.us.com/services.html
InSilico designs and develops sophisticated analytical software tools that assist in extracting biological insights from vast quantities of genomic data.
InSilico builds custom bioinformatics applications that perform complex analysis but that provide users with intuitive, visual interfaces that make exploring the data much easier.
Our applications are robust and user friendly.
InSilico has experience developing custom tools for a variety of different types of data:
-- Next Generation Sequencing (DNA and RNASeq)
-- Microarrays (Expression, Methylation, Copy Number, SNPs)
-- 3D Protein Structures
External Data (UCSC Tracks, Ensembl, NCBI, TCGA, dbSNP, 1000 Genome, COSMIC, etc)
InSilico employs state of the art design methods, code reviews, formal documentation, and automated testing to deliver high quality software applications.
InSilico's Data Interface
http://insilico.us.com/portfolio.html
In collaboration with Dr. Weinstein's BCB Group at MD Anderson, InSilico developed a Next Generation Heat Map Tool with an advanced JavaScript architecture utilizing WebGL for accelerated graphical rendering.
The NGCHM tool handles very large-scale clustered heat maps and brings them to life with pan, zoom, and link-out features delivering a strong platform for exploratory genomics discovery.
InSilico data analytic tools can be run on a web server or stand-alone and has been packaged as a Galaxy tool and a Docker image for easy installation and use in a variety of environments including cloud-based pipelines.
The small square shows in detail the expression of 50 genes on 50 The Cancer Genome Atlas (TGCA) samples.
Smoker (level) and Age.
The genome cancer atlas (TCGA) molecularly characterized over 20,000 primary cancer and matched normal samples spanning 33 cancer types.
TCGA generated over 2.5 petabytes of genomic, epigenomic, transcriptomic, and proteomic data.
InSilico data analytic tools like the above help to navigate in these data.
InSilico's World-Class Collaborations
InSilico has a long-term collaborative relationship with its clients at MD Anderson Cancer Center, Johns Hopkins School of Medicine, and the National Cancer Institute.
Through these collaborations, InSilico has developed many published, open-source cancer research tools that are in broad use by multiple research communities. The team plans to continue these highly productive relationships post-merger.
"InSilico has been a fantastic partner and provided the engineering muscle behind many of our popular cancer research tools.
"Their disciplined, rapid development approach combined with strong skills in software architecture, machine learning, and interface design have been invaluable to our work," said Dr. Rachel Karchin, Professor, Johns Hopkins University. Institute for Computational Medicine, Department of Biomedical Engineering, Department of Oncology, Department of Computer Science.
InSilico and Kiromic CancerDiff
Kiromic has engaged InSilico to develop several of its critical systems for therapeutic target selection including CancerDiff, and the automated Protein Research Assistant.
The algorithms identify tumor specific isoforms with targetable peptides on surface proteins with low probability of off target effects.
Target selection transcends tissue of origin to identify cross-tumor sub-populations with shared, targetable molecular characteristics.
Research functions automate, improve, and shorten previously labor-intensive steps of deep dive target investigation.
See Kiromic's AACR 2021 Poster: CancerDiff by Insilico (Link to AACR 2021 Press Release)
Mesothelin isoform 2 is a novel target for allogenic CARγδT cell therapy in solid tumors
Kiromic 3D, isoform prediction engine which examines billions of data points to select the best targets.
InSilico and Kiromic's Bioinformatics
The InSilico and Kiromic teams have proven to work effectively together in a highly synergistic manner.
Merging InSilico into Kiromic as its Bioinformatics Department will allow the formation of a fully integrated organization with enhanced capability to apply the latest machine learning methods to reduce therapy design timelines and more efficiently deliver effective treatment to patients.
InSilico's Publications
http://insilico.us.com/publications.html
Previous Kiromic Press Release
June 16, 2021: KIROMIC BIOPHARMA PROVIDES UPDATE ON IND FILINGS ON ITS OFF-THE-SHELF, ALLOGENEIC CAR-T FOR SOLID TUMORS
About Kiromic
Kiromic BioPharma, Inc. (NASDAQ:KRBP) is an emerging clinical stage biopharmaceutical company focused on advancing the cellular therapy field, for solid tumors utilizing a state-of-the-art artificial intelligence (AI) platform focused on unleashing the power of the patient's own immune system to fight cancer.
Kiromic's pipeline development is leveraged through the Company's proprietary target discovery Artificial Intelligence engine called "DIAMOND." Kiromic's DIAMOND is big data science meeting target identification, dramatically compressing the man-years and the millions of drug development dollars needed to develop a live drug.
Forward-Looking Statements
This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our company's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the Company's annual report on Form 10-K for the most recently completed fiscal year and subsequent reports filed after the date of the annual report with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and our company undertakes no duty to update such information except as required under applicable law.
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Kiromic BioPharma, Inc. (NASDAQ:KRBP)
Two INDs were submitted to the FDA in May 2021 for the first-in-human off-the-shelf allogeneic CAR-T for Solid Tumors.
FDA returned with comments on the Company's allogeneic CAR-T products with respect to:
-- Tracing of all reagents used in manufacturing
-- Flow chart of manufacturing processes
-- Certificate of Analysis (COA) for the Company's CAR-T products (allogeneic CAR-T)
The company has an FDA response taskforce, staffed with 30 yr industry veterans, working on answering the FDA comments above.
Our CMC processes are rigorous.
Our product is allogeneic gamma delta T cell manufacturing which few companies have mastered.
The company's timeline for commencement of the dosing of its first in human clinical trial is expected to be tighter but we still plan on delivering in 3Q 2021.
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Previous Press Release
June 2, 2021, Kiromic announces the closing of public offering
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About Kiromic
Kiromic BioPharma, Inc. (NASDAQ:KRBP) is a target discovery and gene-editing company utilizing a state-of-the-art artificial intelligence (AI) platform focused on unleashing the power of the patient's own immune system to fight cancer.
Kiromic's pipeline development is leveraged through the Company's proprietary target discovery Artificial Intelligence engine called "DIAMOND." Kiromic's DIAMOND is big data science meeting target identification, dramatically compressing the man-years and the millions of drug development dollars needed to develop a live drug.
Forward-Looking Statements
This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our company's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the Company's annual report on Form 10-K for the most recently completed fiscal year and subsequent reports filed after the date of the annual report with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and our company undertakes no duty to update such information except as required under applicable law.
Source: Kiromic BioPharma, Inc. (www.kiromic.com)
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Kiromic BioPharma, Inc. (NASDAQ:KRBP) (the "Company"), an immuno-oncology target discovery and gene-editing company with a proprietary artificial intelligence neural network platform (Diamond AI) that is used to develop novel oncology therapeutics, today announced the closing of its previously announced underwritten public offering of 8,000,000 shares of its common stock at a public offering price of $5.00 per share, resulting in gross proceeds to the Company of $40 million. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 1,200,000 shares of common stock, solely to cover over-allotments.
ThinkEquity, a division of Fordham Financial Management, Inc. acted as sole book-running manager for the offering.
The Company intends to use the net proceeds from the offering primarily for clinical trials for its ALEXIS-ISO-1 and ALEXIS-PRO-1 product candidates, GMP facility expansion, intellectual property protection and reinforcement, IND applications and IND enabling trials and working capital and the remainder for general corporate purposes.
A registration statement relating to the shares of common stock being sold in this offering was declared effective by the Securities and Exchange Commission (the "SEC") on June 29, 2021. The offering is being made only by means of a prospectus. Copies of the final prospectus may be obtained on the SEC's website, www.sec.gov, or by contacting ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673 or by email at [email protected].
This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Kiromic BioPharma, Inc.
Kiromic BioPharma, Inc. is a target discovery and gene-editing company utilizing a state-of-the-art artificial intelligence (AI) platform focused on unleashing the power of the patient's own immune system to fight cancer.
Kiromic's pipeline development is leveraged through the Company's proprietary target discovery Artificial Intelligence engine called "DIAMOND." Kiromic's DIAMOND is big data science meeting target identification, dramatically compressing the man-years and the millions of drug development dollars needed to develop a live drug.
The Company maintains its HQ offices in the world's largest medical center in Houston, Texas adjacent to the MD Anderson Cancer Center and the Baylor College of Medicine where Kiromic has ongoing collaboration with these Institutions.
Forward-Looking Statement Disclaimer
This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our company's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the Company's annual report on Form 10-K for the most recently completed fiscal year and subsequent reports filed after the date of the annual report with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and our company undertakes no duty to update such information except as required under applicable law.
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Kiromic BioPharma, Inc. (NASDAQ:KRBP) (the "Company"), an immuno-oncology target discovery and gene-editing company with a proprietary artificial intelligence neural network platform (Diamond AI) that is used to develop novel oncology therapeutics, today announced the pricing of its underwritten public offering of 8,000,000 shares of its common stock at a public offering price of $5.00 per share, for gross proceeds of $40 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 1,200,000 shares of common stock, solely to cover over-allotments. All of the shares of common stock are being offered by the Company.
The offering is expected to close on or about July 2, 2021, subject to customary closing conditions.
ThinkEquity, a division of Fordham Financial Management, Inc., is acting as sole book-running manager for the offering.
The Company intends to use the net proceeds from the offering primarily for clinical trials for its ALEXIS-ISO-1 and ALEXIS-PRO-1 product candidates, GMP facility expansion, intellectual property protection and reinforcement, IND applications and IND enabling trials and working capital and the remainder for general corporate purposes.
A registration statement relating to the shares of common stock being sold in this offering was declared effective by the Securities and Exchange Commission (the "SEC") on June 29, 2021. The offering is being made only by means of a prospectus. Copies of the final prospectus may be obtained, when available, on the SEC's website, www.sec.gov, or by contacting ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673 or by email at [email protected].
This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Kiromic BioPharma, Inc.
Kiromic BioPharma, Inc. is a target discovery and gene-editing company utilizing a state-of-the-art artificial intelligence (AI) platform focused on unleashing the power of the patient's own immune system to fight cancer.
Kiromic's pipeline development is leveraged through the Company's proprietary target discovery Artificial Intelligence engine called "DIAMOND." Kiromic's DIAMOND is big data science meeting target identification, dramatically compressing the man-years and the millions of drug development dollars needed to develop a live drug.
The Company maintains its HQ offices in the world's largest medical center in Houston, Texas adjacent to the MD Anderson Cancer Center and the Baylor College of Medicine where Kiromic has ongoing collaboration with these Institutions.
Forward-Looking Statement Disclaimer
This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our company's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the Company's annual report on Form 10-K for the most recently completed fiscal year and subsequent reports filed after the date of the annual report with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and our company undertakes no duty to update such information except as required under applicable law.
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Kiromic Biopharma, Inc. (NASDAQ:KRBP)
Kiromic is being recognized as a pioneer of immuno oncology with a presentation at the 4th Annual Next-Gen Immuno Oncology Congress in June 2021.
At the conference, we will:
-- Present our artificial intelligence (AI) predicted and selected targets, and
-- Discuss how our AI targets will offer better safety and efficacy compared to immuno oncology peers with classic targets.
Our AI targets are predicted and selected based on the following characteristics:
High expression in cancer cells
Heat map of T-cell, B-cell epitopes
Low expression in normal cells
High affinity to TCR
Quantity surface antigen expression signature
We intend to use our AI target, Mesothelin isoform 2, in the upcoming first-in-human dosing for solid tumors in 3Q-2021. At the first-in-human dosing, Kiromic will also introduce a CAR-T with chPD1, our PD1 activator, which will we believe offer immuno oncology with new tools to address Tumor Micro Environment (TME).
Our topics for the session on June 29th are:
-- Mesothelin isoform 2 is a novel target for allogenic CAR γδT cell therapy in solid tumors
-- Diamond Artificial Intelligence /CancerSplice : ADVANCING CAR through A.I. for Target
Link to 4th Annual Next-Gen Immuno Oncology Congress (Virtual) June-28, 2021Chief Executive Officer of Kiromic, Maurizio Chiriva-Internati, DBSc, PhDs, commented:
"We are honored to be invited to present at the 4th Annual Next-Gen Immuno Oncology Congress.
The challenges for immuno oncology and the employment of classic targets result from low specificity, which results in higher side effects and low affinity, which results in low efficacy.
We believe our AI selected iso-mesothelin will address both of these issues.
Our selection and prediction algorithm is robust and extensive, poring over billions of data points, to arrive at these targets in hours which otherwise would have required many man-years if done manually.
We believe that the first-in-human dosing will demonstrate the safety and efficacy of our product and will also demonstrate that AI targeting is superior compared with classic targeting with immuno chemistry."
Chief Medical Officer of Kiromic, Dr. Scott Dahlbeck, commented:
"As an oncologist treating these patients and reading the data, I know first-hand about the needs in immuno oncology to address the problems of specificity and affinity in targeting.
It's very exciting for me to be part of our innovative team that is introducing AI algorithms into the search for better targets.
We are looking forward to the first in-human dosing with these AI targets in 3Q-2021."
Chief Strategy and Innovation of Kiromic, Gianluca Rotino, stated:
"The time has come for the world to see the power of AI algorithms unleashed on targets research and immuno oncology to finally get CAR-T which offers better safety and efficacy compared with classic small molecules."
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Previous Press Release:
About Kiromic
Kiromic BioPharma, Inc. (NASDAQ:KRBP) is a target discovery and gene-editing company utilizing a state-of-the-art artificial intelligence (AI) platform focused on unleashing the power of the patient's own immune system to fight cancer.
Kiromic's pipeline development is leveraged through the Company's proprietary target discovery Artificial Intelligence engine called "DIAMOND." Kiromic's DIAMOND is big data science meeting target identification, dramatically compressing the man-years and the millions of drug development dollars needed to develop a live drug.
Forward-Looking Statements
This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our company's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the Company's annual report on Form 10-K for the most recently completed fiscal year and subsequent reports filed after the date of the annual report with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and our company undertakes no duty to update such information except as required under applicable law.
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