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Kiromic BioPharma, Inc. (NASDAQ:KRBP), an immuno-oncology target discovery and gene-editing company, with a proprietary artificial intelligence neural network platform (Diamond AI) to develop novel oncology therapeutics, has announced the completion of the chPD1 licensing agreement with Longwood University.
- PD-1 has always been a challenge for CAR-T development.
- PD-1 is the brakes of the immune system, inhibiting immune cells from killing tumor cells. Traditional PD-1 inhibitors block the PD-1 receptor, "removing the brakes" of T-cell activity.
- Kiromic's chPD1 not only "removes the brakes" but also engages the PD-1 receptor to "accelerate" T-cell activity.
- Upon interaction with the PD-1 ligand, the chPD1 receptor activates CD3 zeta (the main activating intracellular domain for T cells), and Dap10 (costimulatory domain). The activation of these two intracellular domains induces T cell activation, cytokine secretion, and tumor cell lysis.
"Longwood University is proud to have completed this chPD1 licensing agreement with Kiromic. We believe that Kiromic has a strong Allogenic Off-The-Shelf CAR-T program which will be even stronger with chPD1. The role that chPD1 plays in the modulation of the tumor micro-environment (TME) can never be underestimated when treating solid tumors," says Dr. Amorette Barber, PhD, Associate Professor of Biology and Director of the Office of Student Research at Longwood University.
"The completion of the licensing agreement for chPD1 marks a major milestone for Kiromic CAR-T development. With chPD1, we believe our chimeric PD1 CAR-T will be able to overcome the challenging tumor micro-environment (TME) which has plagued other CAR-T programs," says Dr. Maurizio Chiriva-Internati, PhD, CEO of Kiromic BioPharma.
"We believe that the licensing agreement of chPD1 from Longwood will make Kiromic the only CAR-T development program with a built-in capability to meet other CAR-T programs head-on who do not have a bundled chPD1 CAR-T. We believe that the licensing agreement will place Kiromic in a solid position to begin first in-human in solid tumors," says Mr. Gianluca Rotino, Chief of Strategy and Innovation of Kiromic BioPharma.
About Longwood University
Longwood has a robust research department with 7 post doctorates conducting research in molecular biology, microbiology, genomics, cancer biology, and immunology and publishing over 75 publications in different scientific journals in the past 5 years.
LINK to Longwood University: www.longwood.edu
About Kiromic
Kiromic BioPharma, Inc. is an immuno-oncology biopharmaceutical company focused on discovering, developing, and commercializing novel immuno-oncology applications through its robust product pipeline. The pipeline development is leveraged through the Company's proprietary target discovery engine called "DIAMOND." Kiromic's DIAMOND is essentially 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's headquarters are located in Houston, TX adjacent to the world's largest medical center and the MDACC.
For more information, please visit Kiromic's website at:
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the U.S. Private Securities Litigation Reform Act, Section 21E of the Securities Exchange Act of 1934, as amended, and other federal securities laws. All statements other than statements of historical facts are forward-looking statements. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements include, but are not limited to, statements about our intentions, projections, assessments, or expectations regarding items such as the following:
- our goals and strategies
- research, development, and regulatory activities
- FDA authorization timeline for clinical trial initiation
- clinical trial enrollment or participation by clinical sites
- facility manufacturing capabilities for clinical trial support
- expectations related to gamma delta CAR therapy
- performance and success of clinical trials
- our future business development, financial condition, and results of operations
- expected changes in our revenue, costs, or expenditures
- growth of and competition trends in our industry
- our expectations regarding demand for, and market acceptance of, our products
- our expectations regarding our relationships with investors, institutional funding partners and other parties we collaborate with
- fluctuations in general economic and business conditions in the markets in which we operate; including those fluctuations caused by COVID-19
- relevant government policies and regulations relating to our industry.
In some cases, you can identify forward-looking statements by terms such as "may," "could," "will," "should," "would," "expect," "plan," "intend," "anticipate," "believe," "estimate," "predict," "potential," "project" or "continue" or the negative of these terms or other comparable terminology. These statements are only predictions. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, which are, in some cases, beyond our control and which could materially affect results. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under the heading "Risk Factors" included in our Registration Statement on Form S-1 (file no. 333-238153), originally filed with the Securities and Exchange Commission (SEC) on May 11, 2020, as amended, and elsewhere in this press release. If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual events or results may vary significantly from those implied or projected by the forward-looking statements. No forward-looking statement is a guarantee of future performance.
The forward-looking statements made in this press release relate only to events or information as of the date on which the statements are made in this press release. Except as expressly required by the federal securities laws, there is no undertaking to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances or any other reason. You are advised, however, to review any further disclosures we make on related subjects in our Forms 10-Q, 8-K and other reports filed with the SEC.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210126006078/en/
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Kiromic BioPharma, Inc. (NASDAQ:KRBP), an immuno-oncology target discovery and gene-editing company, with a proprietary artificial intelligence neural network platform (Diamond AI) to develop novel oncology therapeutics, has announced the completion and certification of its GMP facility in Houston, Texas:
- GMP facility construction is complete and certified to meet all FDA required regulatory guidelines.
- GMP facility is ready to support our upcoming first in-human, off-the-shelf, allogenic CAR-T trial. The CAR-T ovarian cancer trials will have these targets: chPD1 Gamma-Delta and anti-ISOMSLN.
- Gamma-Delta-T cell (GDT cell) GMP manufacturing test batch optimization and qualification studies are proceeding as scheduled.
"The in-house capability to manufacture allogenic, off-the-shelf CAR products removes a layer of complexity in the workflow, which we believe will greatly enhance our ability to move swiftly through our CAR-T trials," says Dr. Maurizio Chiriva-Internati, PhD, CEO of Kiromic BioPharma.
"The key features of the facility have been completed, clearing the path for the production of our off-the-shelf Gamma-Delta-T cells, a novel approach to CAR-T cell therapy, which will be evaluated in the upcoming clinical trials," says David Aguilar, PhD, Head of CMC Manufacturing of Kiromic BioPharma.
"Thanks to the hard work of our scientists, contractor engineers, suppliers, and the third party certifiers, our Houston Facility is completing the final steps needed for launching the next-generation of allogenic, off-the-shelf CAR-T," says Mr. Tony Tontat, CFO, COO of Kiromic BioPharma.
(chPD1: Chimeric PD1; ISOMSLN: Iso-mesothelin; CAR: Chimeric Antigen Receptors)
About Allogenic Gamma-Delta-T cells
GDT cells are a small fraction of blood lymphocytes, but they are the predominant T cell type in epithelia, where they patrol the barrier between the body and the outside world, with their potent multi-anti-pathogen abilities. Compared with alpha-beta-T cells (ABT), currently used in CAR therapies, GDT cells are more efficient in killing tumor cells and more resistant to mechanisms by which solid tumors escape from the immune system.
Furthermore, unlike ABT cells, GDT cells manufacturing does not require the patient's blood, but can be produced using the blood of healthy donors, a process called allogenic cell transfer. This is possible because, while ABT cells from another individual will attack a patient's normal organs, GDT cells will only target the tumor target for which they were engineered, leaving non-tumoral cells untouched.
The workflow of CAR-T therapy is as follows:
- The GDT cells are grown and purified from the blood of healthy individuals.
- The GDT cells are expanded with a proprietary process.
- The GDT cells are then genetically modified to target tumor antigens discovered by Kiromic's Diamond AI technology, resulting in the next generation of CAR-T cell therapy for solid malignancies.
About Kiromic
Kiromic BioPharma, Inc. is an immuno-oncology biopharmaceutical company focused on discovering, developing, and commercializing novel immuno-oncology applications through its robust product pipeline. The pipeline development is leveraged through the Company's proprietary target discovery engine called "DIAMOND." Kiromic's DIAMOND is essentially 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's headquarters are located in Houston, TX adjacent to the world's largest medical center and the MD Anderson Cancer Center.
For more information, please visit Kiromic's website at:
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the U.S. Private Securities Litigation Reform Act, Section 21E of the Securities Exchange Act of 1934, as amended, and other federal securities laws. All statements other than statements of historical facts are forward-looking statements. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements include, but are not limited to, statements about our intentions, projections, assessments, or expectations regarding items such as the following:
- our goals and strategies
- research, development, and regulatory activities
- FDA authorization timeline for clinical trial initiation
- clinical trial enrollment or participation by clinical sites
- facility manufacturing capabilities for clinical trial support
- expectations related to gamma delta CAR therapy
- performance and success of clinical trials
- our future business development, financial condition, and results of operations
- expected changes in our revenue, costs, or expenditures
- growth of and competition trends in our industry
- our expectations regarding demand for, and market acceptance of, our products
- our expectations regarding our relationships with investors, institutional funding partners and other parties we collaborate with
- fluctuations in general economic and business conditions in the markets in which we operate; including those fluctuations caused by COVID-19
- relevant government policies and regulations relating to our industry.
In some cases, you can identify forward-looking statements by terms such as "may," "could," "will," "should," "would," "expect," "plan," "intend," "anticipate," "believe," "estimate," "predict," "potential," "project" or "continue" or the negative of these terms or other comparable terminology. These statements are only predictions. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, which are, in some cases, beyond our control and which could materially affect results. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under the heading "Risk Factors" included in our Registration Statement on Form S-1 (file no. 333-238153), originally filed with the Securities and Exchange Commission (SEC) on May 11, 2020, as amended, and elsewhere in this press release. If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual events or results may vary significantly from those implied or projected by the forward-looking statements. No forward-looking statement is a guarantee of future performance.
The forward-looking statements made in this press release relate only to events or information as of the date on which the statements are made in this press release. Except as expressly required by the federal securities laws, there is no undertaking to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances or any other reason. You are advised, however, to review any further disclosures we make on related subjects in our Forms 10-Q, 8-K and other reports filed with the SEC.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210119006187/en/
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Kiromic Biopharma, Inc. (NASDAQ:KRBP), a target discovery and gene-editing company utilizing artificial intelligence and proprietary neural network platform with a therapeutic focus on immuno-oncology, announces the filing of key European patents for its chimeric PD-1 (chPD1) target.
- Kiromic chPD1 receptor targets PD-1 ligands expressed on many different types of cancer cells, including ovarian, pancreatic, prostate, colon, kidney, and breast cancer and melanoma.
- Kiromic chPD1-expressing T-cells engage with the PD-1 ligands on the surface of the cancer cells and this interaction activates the T-cells to directly kill the tumor cells.
- Kiromic chPD1 has shown in preclinical data to show a cytotoxic response in 9 different in vivo models with 100% long-term PFS with the induction of host memory responses.
- chPD1 will be used in the Company's proprietary chimeric antigen receptor therapy (CAR-T) platform using gamma-delta T-cells (GD-T).
Kiromic's deep understanding of the tumor micro environment (TME) and the tumors' escape and masking mechanisms led to development of a promising platform for chimeric antigen receptor therapy (CAR-T).
We believe our allogenic CAR-T platform is significantly stronger with chPD1 target licensed from Longwood University.
Prof. Amorette Barber of Longwood University will be heading up our chPD1 program.
"We believe Prof. Barber's work will give Kiromic a significant acceleration in the clinical development of its therapy platform and an even more significant advantage over its competitors. We believe this collaboration marks the beginning of an exciting revolution in cell therapies," said Gianluca Rotino, Chief of Strategy and Innovation Officer.
"chPD1 is an exciting and differentiated target for our allogenic CAR-T solid tumors platform. We look forward to updating you in the months ahead as we move closer to filing our first IND with our chPD1 for ovarian cancer," said Maurizio Chiriva-Internati, PhD, CEO of Kiromic Biopharma.
About PD-1 Check-point inhibition
PD-1 has always been a challenge for CAR-T development. PD-1 is the brakes of the immune system, inhibiting immune cells from killing tumor cells.
Traditional PD-1 inhibitors block the PD-1 receptor, "removing the brakes" of T-cell activity. Conversely, Kiromic's chPD1 not only "removes the brakes" but also engages the PD-1 receptor to "accelerate" T-cell activity.
About Kiromic chPD1 Mechanism of Action
Kiromic's chPD1 receptor targets PD-1 ligands expressed on many different types of cancer cells, including ovarian, pancreatic, prostate, colon, kidney, and breast cancer and melanoma.
Chimeric PD-1-expressing T-cells engage with the PD-1 ligands on the surface of the cancer cells and this interaction activates the T-cells to directly kill the tumor cells. Chimeric PD-1 T-cells also release cytokines to further initiate immune responses to eradicate the tumor cells.
Through expression of the chPD1 receptor, the inhibitory signal the T-cells would have received through engagement of the PD-1 ligands on tumor cells now acts as an activating signal and induces destruction of tumors. A large variety of cancer types express PD-1 ligands thus the chPD1 T-cells could potentially be used to treat many types of tumors.
About Dr. Amorette Barber (Longwood University)
Dr. Barber is an associate professor of biology and director of the Office of Student Research. Dr. Barber is in her tenth year at Longwood and serves as the President-Elect of the Virginia Academy of Science.
Dr. Barber is a tumor immunologist. She is an expert in chimeric antigen T-cells. Her research focuses on determining the role costimulatory domains play in enhancing chimeric T-cell activity and the creation and testing of the chPD1 receptor as a therapy for multiple types of cancer.
Dr. Barber has had 26 publications in cellular signaling in the following scientific journals: The Journal of Clinical Investigation, Blood, Cancer Research, The Journal of Immunology, and many others.
Link to her profile: http://www.longwood.edu/directory/profile/barberarlongwoodedu/
Dr. Barber also serves on Kiromic's Scientific Advisory Board.
About Longwood University
Longwood has a robust research department with 7 post doctorates conducting research in molecular biology, microbiology, genomics, cancer biology, and immunology and publishing over 75 publications in different scientific journals in the past 5 years.
Link to Longwood University: www.longwood.edu
About Kiromic
Kiromic BioPharma, Inc. is a preclinical stage biopharmaceutical company which is focused on discovering, developing, and commercializing novel immune-oncology applications through its robust product pipeline. The pipeline development is leveraged through the Company's proprietary target discovery engine called "DIAMOND." Kiromic's DIAMOND is big data science meeting target identification, dramatically compressing man-years and billions of drug development dollars to develop a live drug. The Company maintains offices in Houston, Texas.
For more information, please visit the company's website at www.kiromic.com.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the U.S. Private Securities Litigation Reform Act, Section 21E of the Securities Exchange Act of 1934, as amended, and other federal securities laws. All statements other than statements of historical facts are forward-looking statements. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements include, but are not limited to, statements about:
- our goals and strategies;
- our future business development, financial condition and results of operations;
- expected changes in our revenue, costs or expenditures;
- growth of and competition trends in our industry;
- our expectations regarding demand for, and market acceptance of, our products;
- our expectations regarding our relationships with investors, institutional funding partners and other parties we collaborate with;
- fluctuations in general economic and business conditions in the markets in which we operate; including those fluctuations caused by COVID-19; and
- relevant government policies and regulations relating to our industry.
In some cases, you can identify forward-looking statements by terms such as "may," "could," "will," "should," "would," "expect," "plan," "intend," "anticipate," "believe," "estimate," "predict," "potential," "project" or "continue" or the negative of these terms or other comparable terminology. These statements are only predictions. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties and other factors, which are, in some cases, beyond our control and which could materially affect results. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under the heading "Risk Factors" included in our Registration Statement on Form S-1 (file no. 333-238153), originally filed with the Securities and Exchange Commission (SEC) on May 11, 2020, as amended, and elsewhere in this press release. If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual events or results may vary significantly from those implied or projected by the forward-looking statements. No forward-looking statement is a guarantee of future performance.
The forward-looking statements made in this press release relate only to events or information as of the date on which the statements are made in this press release. Except as expressly required by the federal securities laws, there is no undertaking to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances or any other reason. You are advised, however, to review any further disclosures we make on related subjects in our Forms 10-Q, 8-K and other reports filed with the SEC.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210104005863/en/
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Kiromic BioPharma ("the Company") (NASDAQ:KRBP), a target discovery and gene-editing company utilizing artificial intelligence and its proprietary neural network platform with a therapeutic focus on immuno-oncology, announced today the submission of two investigational new drug (IND) applications with the U.S. Food and Drug Administration (FDA) for the initiation of:
--- Phase 1 clinical trial of an intravenously (IV) administered allogenic CAR-T for epithelial ovarian carcinoma (EOC) and malignant pleural mesothelioma (MPM) and
--- Phase 1 clinical trial of an intrapleural/intraperitoneal (IP) administered allogenic CAR-T for EOC and MPM.
Kiromic's proprietary PD1 Gamma-delta CAR (PD1-GDT CAR) T cell therapy is a novel method for "off-the-shelf" allogeneic CAR T cells derived from healthy donors. We believe our proprietary gamma-delta T cell manufacturing and distribution will offer significant advantages over competitive manufacturing technologies.
The initial dose escalation component of each CAR-T trial is projected to enroll approximately 12 patients over 4 months at two sites.
The first in-human dosing is targeted for 1Q-2021.
"It's an exciting time to see our technology go into the clinic. This is the culmination of +25 years of research and development which has spanned the globe with international contributions and scientific collaborations from the sharpest minds of our time. Our gamma-delta T-cells are designed to offer clinicians a treatment option with:
-- higher efficacy,
-- higher safety (reducing graft vs. host risks), and
-- lower manufacturing and distribution costs vs. cellular therapy technologies of the past," says Dr. Maurizio Chiriva-Internati, PhD, CEO of Kiromic.
"This first in-human off-the-shelf allogenic gamma-delta chPD1 CAR-T cell therapy trial will mark a major milestone, not only for Kiromic, but also for clinicians who have been frustrated with the lack of CAR T cell treatment options for solid malignancies, since current CAR T cell therapies are only approved for hematologic malignancies, with all of the drawbacks of autologous based platforms," commented Dr. Scott Dahlbeck, MD, Chief Medical Officer of Kiromic.
"The cGMP suite consists of 5 clean rooms which will be used to manufacture the Company's off-the-shelf allogeneic therapies during clinical trials. The Company is fully ready for this IND filing and has the clinical manufacturing capability to supply its clinical trials," commented Mr. Tony Tontat, CFO, COO of Kiromic.
"Kiromic's proprietary PD1 Gamma-delta CAR (PD1-GDT CAR) T cell therapy is a novel method for "off-the-shelf" allogeneic CART T Cells derived from healthy donors. As we continue to grow our targets and our clinical programs, our IP portfolio is continually being fortified in all major geographies, and we look forward to updating our investors in upcoming presentations and filings," commented Mr. Gianluca Rotino, Chief of Strategy and Innovations of Kiromic.
About Epithelial Ovarian Carcinoma
Ovarian tumors grow rapidly and metastasize early with a very aggressive disease course, either through direct extension from the ovarian/fallopian tumor to neighboring organs (bladder/colon), or by detaching from the primary tumor, and then spreading and adhering to intraperitoneal organs.
Epithelial ovarian carcinoma represents the vast majority of ovarian cancers and the most common histologic subtype is high grade serous epithelial ovarian carcinoma. Unlike most other cancers, ovarian carcinoma rarely disseminates through the vasculature, although pelvic and/or para-aortic lymph nodes can be involved. When ovarian cancer spreads to the mesothelium of the organs within the peritoneal cavity, it can result in encasement of these organs with significant pain and eventual obstruction of the stomach, large, and small intestines.
Despite advances in surgical techniques and intensive combination chemotherapy approaches, the survival rate substantially decreases after ovarian cancer has metastasized to pelvic organs (such as the uterus, fallopian tubes, bladder, and rectum), metastasized across the pelvic cavity to the abdominal organs and tissue (such as the omentum, small intestine, and retroperitoneal lymph nodes), or metastasized beyond the peritoneal cavity to distant parenchymal organs such as the liver and lung.
The ovarian cancer tumor microenvironment (TME) within the peritoneal cavity is a key element in the support of ovarian cancer growth, and only by addressing the TME, along with the ovarian cancer tumor cell itself, will significant advances be achieved.
Since ovarian cancer 5 year survival statistics have improved only slightly over the last few decades, innovative approaches such as Kiromic's administration of a PD1-GDT CAR, which is designed to address the TME of EOC, are desperately needed.
About Malignant Pleural Mesothelioma
Patients with a diagnosis of mesothelioma are generally considered to be incurable, and typically present late, with multiple signs and symptoms such as shortness of breath, chest pain, cough, hemoptysis, dysphagia, weight loss, fatigue, night sweats, and face/arm swelling which often precludes surgical options. Chemotherapy and radiation therapy are also options but are often only palliative, with or without an attempted surgical resection.
If the patient is one of the few considered to be a surgical candidate, the surgical objective will be to obtain a maximal cellular reduction (MCR), followed by chemotherapy +/- radiation therapy. Yet even with an MCR and adjuvant therapies, the vast majority of patients still experience a recurrence, most of which are local, and when the tumors do recur, second line treatments are essentially palliative.
Hence, the majority of patients suffering from this disease need innovative and novel treatment options, as most patients will ultimately die of their disease with a poor remaining quality of life due to symptoms such as severe shortness of breath and chest pain, due to hardening of the pleura associated with the inevitable disease progression. Innovative approaches such as Kiromic's administration of a PD1-GDT CAR, which is designed to address the tumor microenvironment (TME) of MPM are urgently needed.
About Kiromic
Kiromic BioPharma, Inc. is a preclinical stage biopharmaceutical company which is focused on discovering, developing, and commercializing novel immune-oncology applications through its robust product pipeline. The pipeline development is leveraged through the Company's proprietary target discovery engine called "DIAMOND." Kiromic's DIAMOND is big data science meeting target identification, dramatically compressing man-years and billions of drug development dollars to develop a live drug. The Company maintains offices in Houston, Texas.
For more information, please visit the company's website at www.kiromic.com.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the U.S. Private Securities Litigation Reform Act, Section 21E of the Securities Exchange Act of 1934, as amended, and other federal securities laws. All statements other than statements of historical facts are forward-looking statements. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements include, but are not limited to, statements about:
- our goals and strategies;
- our future business development, financial condition and results of operations;
- expected changes in our revenue, costs or expenditures;
- growth of and competition trends in our industry;
- our expectations regarding demand for, and market acceptance of, our products;
- our expectations regarding our relationships with investors, institutional funding partners and other parties we collaborate with;
- fluctuations in general economic and business conditions in the markets in which we operate; including those fluctuations caused by COVID-19; and
- relevant government policies and regulations relating to our industry.
In some cases, you can identify forward-looking statements by terms such as "may," "could," "will," "should," "would," "expect," "plan," "intend," "anticipate," "believe," "estimate," "predict," "potential," "project" or "continue" or the negative of these terms or other comparable terminology. These statements are only predictions. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties and other factors, which are, in some cases, beyond our control and which could materially affect results. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under the heading "Risk Factors" included in our Registration Statement on Form S-1 (file no. 333-238153) , originally filed with the Securities and Exchange Commission (SEC) on May 11, 2020, as amended, and elsewhere in this press release. If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual events or results may vary significantly from those implied or projected by the forward-looking statements. No forward-looking statement is a guarantee of future performance.
The forward-looking statements made in this press release relate only to events or information as of the date on which the statements are made in this press release. Except as expressly required by the federal securities laws, there is no undertaking to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances or any other reason. You are advised, however, to review any further disclosures we make on related subjects in our Forms 10-Q, 8-K and other reports filed with the SEC.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201217005901/en/
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- Provisional patent filing titled, "Mesothelin Isoform Binding Molecules and Uses Thereof"
- Completed external validation of clinical samples of key Isoform Mesothelin targets
- Completed Construction of Vivarium and Clean Room Facilities at the Houston Offices
Kiromic BioPharma ("the Company") (NASDAQ:KRBP), a pre-clinical stage biotechnology company using its proprietary DIAMOND® artificial intelligence ("A.I.") platform to improve drug discovery and development with a therapeutic focus on immune-oncology, today announced its financial results for the third quarter ended September 30, 2020, and provided an update on its corporate developments.
"Kiromic BioPharma achieved important scientific and operational milestones during the quarter that have us well positioned for growth as we focus on being the leader in A.I.-enabled immune-oncology drug development," said Dr. Maurizio Chiriva-Internati, CEO and President of Kiromic BioPharma. "We are thankful to our employees and collaborators who have maintained this high level of execution in the middle of the hard challenges posed by the COVID-19 pandemic. Through their efforts, as of today nothing has come to our attention causing us to believe that we are not poised to file our two INDs for Epithelial Ovarian Cancer during 4Q-2020. The first IND will be our chimeric PD1 for ovarian cancer, and the second IND will be our isoform mesothelin in ovarian cancer."
Subsequent to the quarter end, on October 20, 2020, we completed a successful IPO, raising gross proceeds of $15,000,000, significantly strengthening the Company's balance sheet to support the continued development of our promising pipeline of targeted cancer therapies. Our approach and goal is to defeat cancer by developing immunotherapies that rely on improving target discovery and validation. With better targets, we believe our therapies will be more effective than the current crop of immunotherapies using older targets.
Corporate and Scientific Highlights
- Intellectual Property Application Filing – Kiromic BioPharma ("The Company") filed a United States provisional patent application on July 6, 2020, entitled "Mesothelin Isoform Binding Molecules and Uses Thereof," that discloses engineered gamma-delta T cells containing mesothelin isoform-directed molecules. This provisional application is expected to expire on July 7, 2021, and the Company plans to file at least an international PCT patent application claiming priority to the provisional application before it expires. The Company plans to build at least one patent family directed to engineered allogeneic effector cells, in support of its development of off-the-shelf allogeneic immunotherapy treatments to patients with indications of Isoform Mesothelin Epithelial Ovarian Cancer, and Isoform Mesothelin Malignant Pleural Mesothelioma.
- External Validation of Targets - The Company completed external validation of Isoform Mesothelin targets including mesothelioma, ovarian cancer, and pancreatic cancer during the 3 months ended September 30, 2020.
- Clean Rooms and Vivarium Facility Construction Completion - The Company completed construction of an $820,000 leasehold improvement located at the Houston, TX based offices. The asset contains a current Good Lab Practices ("cGLP") Vivarium Facility, and current Good Manufacturing Practices ("cGMP") Clean Rooms for clinical manufacturing. The cGLP Vivarium is currently being used to perform key in vivo non-clinical research to support the Company's clinical initiatives through an Initial New Drug ("IND") filing with the FDA. The cGMP suite consists of 5 clean rooms which will be used to manufacture the Company's off-the-shelf allogeneic therapies during clinical trials. Management plans to commence clinical trials only if IND applications are approved by the FDA.
Q3 2020 Financial Highlights
Cash Position: Cash and cash equivalents were $469,300 as of September 30, 2020, compared to $1,929,100 as of December 31, 2019. The decrease was primarily due to cash outflows of $3,557,200 and $1,013,100 attributable to operating activities and investing activities, respectively. The offsetting cash inflows of $3,110,500 was attributed to financing activities related to the Company's Series B Preferred Stock issuance along with proceeds net of repayments from the Paycheck Protection Program loan.
R&D Expenses: Research and development expenses were $1,225,700 for the quarter ended September 30, 2020, compared to $272,100 for the quarter ended September 30, 2019. The increase was primarily attributable to augmented headcount, increased square footage to our Houston, TX leased facilities, and in-vitro experimentation costs.
G&A Expenses: General and administrative expenses were $1,190,000 for the quarter ended September 30, 2020, compared to $607,400 for the quarter ended September 30, 2019. This increase was primarily due to personnel expenses.
Net Loss: Net loss was $2,415,700 for the quarter ended September 30, 2020, compared to a net loss of $886,900 for the quarter ended September 30, 2019.
Dr. Chiriva-Internati continued, "Developing live-cell therapies by leveraging artificial intelligence is central to transforming the cost and efficiency of the immune-oncology field and improving the potential for off-the-shelf therapies for cancer patients. We believe our approach will help us design more efficient pre-clinical validation studies and more targeted clinical trials, thereby accelerating our drug candidates' time to approval and eventually to market. DIAMOND is central to our process in achieving this outcome rapidly and with reduced costs," concluded Dr. Chiriva-Internati.
About Kiromic BioPharma
Kiromic BioPharma, Inc. is a preclinical stage biopharmaceutical company which is focused on discovering, developing, and commercializing novel immune-oncology applications through its robust product pipeline, which are in the pre-IND validation stages of the United States Food and Drug Administration clinical trial process. The pipeline development is leveraged through the Company's proprietary target discovery engine called "DIAMOND." Kiromic's DIAMOND is big data science meeting target identification, dramatically compressing man-years and billions of drug development dollars to develop a live drug. The Company maintains offices in Houston, Texas. The Company has not generated any revenues to date. For more information, please visit the company's website at www.kiromic.com.
Forward-looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the U.S. Private Securities Litigation Reform Act, Section 21E of the Securities Exchange Act of 1934, as amended, and other federal securities laws. All statements other than statements of historical facts are forward-looking statements. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements include, but are not limited to, statements about:
- our goals and strategies;
- our future business development, financial condition and results of operations;
- expected changes in our revenue, costs or expenditures;
- growth of and competition trends in our industry;
- our expectations regarding demand for, and market acceptance of, our products;
- our expectations regarding our relationships with investors, institutional funding partners and other parties we collaborate with;
- fluctuations in general economic and business conditions in the markets in which we operate; including those fluctuations caused by COVID-19; and
- relevant government policies and regulations relating to our industry.
In some cases, you can identify forward-looking statements by terms such as "may," "could," "will," "should," "would," "expect," "plan," "intend," "anticipate," "believe," "estimate," "predict," "potential," "project" or "continue" or the negative of these terms or other comparable terminology. These statements are only predictions. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties and other factors, which are, in some cases, beyond our control and which could materially affect results. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under the heading "Risk Factors" included in our Registration Statement on Form S-1 (file no. 333-238153) , originally filed with the Securities and Exchange Commission (SEC) on May 11, 2020, as amended, and elsewhere in this press release. If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual events or results may vary significantly from those implied or projected by the forward-looking statements. No forward-looking statement is a guarantee of future performance.
The forward-looking statements made in this press release relate only to events or information as of the date on which the statements are made in this press release. Except as expressly required by the federal securities laws, there is no undertaking to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances or any other reason. You are advised, however, to review any further disclosures we make on related subjects in our subsequent Forms 10-Q, 8-K and other reports filed with the SEC.
KIROMIC BIOPHARMA, INC.
Condensed Consolidated Balance Sheets
(Unaudited)
September 30,
December 31,
2020
2019
Assets
Current Assets:
Cash and cash equivalents
$
469,300
$
1,929,100
Inventories
22,200
22,200
Prepaid expenses and other current assets
1,051,900
89,100
Total current assets
1,543,400
2,040,400
Property and equipment, net
1,612,300
587,900
Other assets
24,400
24,400
Total Assets
$
3,180,100
$
2,652,700
Liabilities and Stockholders' Equity:
Current Liabilities:
Accounts payable
$
1,672,900
$
452,400
Accrued expenses and other current liabilities
473,000
221,300
Loan payable
105,600
—
Total current liabilities
2,251,500
673,700
Total Liabilities
2,251,500
673,700
Commitments and contingencies (Note 8)
Stockholders' Equity:
Series A‑1 Preferred Stock, $0.0001 par value: 24,000,000 shares authorized as of September 30, 2020 and December 31, 2019; 21,822,301 shares issued and outstanding as of September 30, 2020 and December 31, 2019
9,134,700
9,134,700
Series B Preferred Stock, $0.0001 par value: 16,500,000 and 14,130,435 shares authorized as of September 30, 2020 and December 31, 2019, respectively; 16,391,397 and 9,869,659 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively
2,331,300
1,306,900
Preferred Stock, $0.0001 par value: 19,500,000 and 21,869,565 shares authorized as of September 30, 2020 and December 31, 2019, respectively; 0 shares issued and outstanding as of September 30, 2020 and December 31, 2019
—
—
Common stock: 300,000,000 shares authorized as of September 30, 2020 and December 31, 2019; 4,989,269 and 2,863,812 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively
—
—
Additional paid-in capital
27,525,500
13,965,000
Accumulated deficit
(38,062,900
)
(22,427,600
)
Total Stockholders' Equity
928,600
1,979,000
Total Liabilities and Stockholders' Equity
$
3,180,100
$
2,652,700
KIROMIC BIOPHARMA, INC.
Condensed Consolidated Statements of Operations
(Unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2020
2019
2020
2019
Operating expenses:
Research and development
$
1,225,700
$
272,100
$
3,526,100
$
601,500
General and administrative
1,190,000
607,400
12,109,200
934,300
Total operating expenses
2,415,700
879,500
15,635,300
1,535,800
Loss from operations
(2,415,700
)
(879,500
)
(15,635,300
)
(1,535,800
)
Other expense
Interest expense
—
(7,400
)
—
(22,400
)
Total other expense
—
(7,400
)
—
(22,400
)
Net loss
$
(2,415,700
)
$
(886,900
)
$
(15,635,300
)
$
(1,558,200
)
Net loss per share, basic and diluted
$
(0.65
)
$
(0.32
)
$
(4.39
)
$
(0.55
)
Weighted average common shares outstanding, basic and diluted
3,719,132
2,862,523
3,719,132
2,862,523
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