KRBP Kiromic BioPharma Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
KiroVAX/BSK01 and chemotherapy
Solid Cancer Tumors
|
Phase 1
Phase 1
|
Phase 1 clinical trial demonstrated PFS of 7 months after treatment versus PFS of 3.9 months with second line chemotherapy, noted October 25, 2021.
|
|
KB-ISM (ALEXIS-ISO-1)
Solid tumors
|
Phase 1
Phase 1
|
Phase 1 dosing to commence 1Q 2022.
|
Latest News
-
View Full Article Hide Full Article
Kiromic BioPharma, Inc. (NASDAQ:KRBP) ("Kiromic" or the "Company"), a clinical-stage fully integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence (AI) and big data mining platform to discover and develop cell and gene therapies with a therapeutic focus on immuno-oncology and other diseases, today announced that it received a written notice (the "Notice") on November 18, 2021 from the Listing Qualifications Department of The Nasdaq Stock Market ("Nasdaq") advising the Company that it was not in compliance with Nasdaq's continued listing requirements under the Nasdaq Listing Rule 5250(c)(1) (the "Rule") as a result of its failure to file its Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 (the "Form 10-Q") in a timely manner.
As previously reported by the Company in its Form 12b-25 filed with the Securities and Exchange Commission ("SEC") on November 16, 2021, the Company was unable to file its Form 10-Q within the prescribed time period without unreasonable effort or expense.
Nasdaq has informed the Company that, under Nasdaq rules, the Company has 60 calendar days to submit a plan to regain compliance with the Rule. If Nasdaq accepts the Company's plan, then Nasdaq may grant an exception of up to 180 calendar days from the Filing's due date of the Form 10-Q, or until May 16, 2022, to regain compliance. If Nasdaq does not accept the Company's plan, then the Company will have the opportunity to appeal that decision to a Nasdaq hearings panel.
The Notice has no immediate effect on the listing or trading of the Company's securities.
The Company is working diligently to complete its Form 10-Q. The Company intends to file the Form 10-Q with the SEC as promptly as practicable.
About Kiromic BioPharma
Kiromic BioPharma, Inc. is a clinical-stage, fully integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence (AI) platform to discover and develop cell and gene therapies with a therapeutic focus on immuno-oncology and other diseases. Kiromic is in the process of developing a multi-indication allogeneic CAR-T cell therapy that exploits the natural potency of Gamma Delta T-cells to target solid cancers.
From its heritage as a cancer vaccine development company, Kiromic is 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 where big data science meets target identification to dramatically compress the man-years and billions of drug development dollars required to develop a live drug. The Company maintains offices in Houston, Texas. To learn more, visit www.kiromic.com and connect with us on Twitter and LinkedIn.
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 the timing or outcome of the Nasdaq listing qualification deficiency process or the ability of the Company to successfully maintain its Nasdaq listing and the timing of the filing of the Form 10-Q.
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. 333-257427), originally filed with the SEC on June 25, 2021, 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 report relate only to events or information as of the date on which the statements are made in this report. 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211124006256/en/
-
View Full Article Hide Full Article
- Progression Free Survival of 7 months after Treatment with KiroVAX/BSK01 and Chemotherapy Versus 3.9 months with Standard of Care
- KiroVax/BSK01 Underscores the Company's Cellular Therapy Approach to Treating Solid Cancer Tumors
- Advancement of KiroVax/BSK01 Leverages Acceleration of Regulatory Pathways, Improvements in Manufacturing Yield, and Potential as an Adjuvant Treatment to Improve Efficacy of Company's Broader Pipeline
Kiromic BioPharma, Inc. (NASDAQ:KRBP) ("Kiromic" or the "Company"), a clinical-stage fully integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence (AI) platform to discover and develop cell and gene therapies with a therapeutic focus on immuno-oncology and other diseases, today announces the results of a published pilot Phase 1 clinical trial that showed KiroVax/BSK01, Kiromic's cell therapy cancer vaccine candidate, in combination with chemotherapy, demonstrated a significant progression free survival (PFS) benefit in one of the patients with metastatic pancreatic cancer who participated in the trial.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211025005273/en/
Figure 1: stable disease in a pancreatic cancer patient with lung metastasis which initially increased in size to 270mm2 and then subsequently stabilized at 100mm2 after three months of treatment with KiroVax/BSK01 in combination with chemotherapy (Photo: Business Wire)
The results from the pilot Phase 1 clinical trial demonstrated PFS of 7 months after treatment with KiroVAX/BSK01 and chemotherapy versus PFS of 3.9 months with second line chemotherapy.
"We are very proud of the results we achieved with KiroVax/BSK01 in addressing advanced metastatic pancreatic cancer. We believe that this is an exciting study, as we believe it demonstrates Kiromic's early clinical success in the cellular therapy arena," stated Maurizio Chiriva Internati, DBSc, PhDs, President, Chief Executive Officer, Chairman, and Founder of Kiromic BioPharma. "By reaffirming this published clinical study we intend to illustrate Kiromic's robust cellular therapy platform, and accordingly, we believe that KiroVAX/BSK01 may have a powerful and synergistic impact as an adjuvant to our novel and innate immunity cellular therapy pipeline. As we did with KiroVax/BSK01, we expect to be able to also progress Kiromic's CAR-T therapies to the clinical arena."
Metastasis is the spread of cancer cells from the place where they first formed to another part of the body. In metastasis, cancer cells break away from the original (primary) tumor, travel through the blood or lymph system, and form a new tumor in other organs or tissues of the body. The new, metastatic tumor is the same type of cancer as the primary tumor.
The scans in figure 1 illustrate stable disease in a pancreatic cancer patient with lung metastasis which initially increased in size to 270mm2 and then subsequently stabilized at 100mm2 after three months of treatment with KiroVax/BSK01 in combination with chemotherapy, resulting in a progression free survival (PFS) of 7 months.
More information on this Phase 1 clinical trial may be found on the Company's website.
Based on these encouraging results, the Company intends to evaluate the potential role of KiroVax/BSK01 as an adjuvant in combination with its growing innate immunity cellular therapy platform. Kiromic added to its innate immunotherapy portfolio by also developing multi-indication, Gamma Delta T-cells, which have the added commercial advantage of being "off-the-shelf" cellular therapeutic candidates to address solid tumor cancers.
About KiroVax/BSK01
KiroVax/BSK01, the Company's Phase 1 cell therapy cancer vaccine candidate, consists of professional antigen presenting cells that are matured and pulsed with tumor specific antigens, yielding a tumor-targeted, next-generation cell therapy vaccine designed for the therapeutic treatment of multiple types of solid cancer tumors. The Company plans on progressing KiroVax/BSK01 into subsequent clinical trials.
About Kiromic BioPharma
Kiromic BioPharma, Inc. is a clinical-stage, fully integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence (AI) platform to discover and develop cell and gene therapies with a therapeutic focus on immuno-oncology and other diseases. Kiromic is in the process of developing a multi-indication allogeneic CAR-T cell therapy that exploits the natural potency of Gamma Delta T-cells to target solid cancers.
From its heritage as a cancer vaccine development company, Kiromic is 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 where big data science meets target identification to dramatically compress the man-years and billions of drug development dollars required to develop a live drug. The Company maintains offices in Houston, Texas. To learn more, visit www.kiromic.com and connect with us on Twitter and LinkedIn.
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: the use of KiroVax/BSK01 to treat metastatic solid malignancies including advanced metastatic pancreatic cancer; how clinical studies are indications of the Company's clinical success in the cellular therapy arena; the impact of KiroVAX/BSK01 will have on the Company's immunity cellular therapy pipeline; and the future role of KiroVax/BSK01 as an adjuvant in combination with the Company's growing innate immunity cellular therapy platform.
In some cases, you can identify forward-looking statements by terms such as "we believe," "may," "in coming years," "could," "by," "if," "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 risks described in our filings with the Securities and Exchange Commission (SEC), including those discussed in our annual report on Form 10-K for the year ended December 31, 2020, in our quarterly reports on Form 10-Q for any subsequent quarterly periods, 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 report relate only to events or information as of the date on which the statements are made in this report. 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211025005273/en/
-
View Full Article Hide Full Article
Alexis ISO-1 is Company's First Artificial Intelligence-identified, Gamma Delta T Cell Engineered Iso-Mesothelin Candidate to Address Solid Tumor Cancers
Company Also Provides Guidance on Regulatory Pathway
Kiromic BioPharma, Inc. (NASDAQ:KRBP) ("Kiromic" or the "Company"), a pre-clinical stage biotechnology company using its proprietary DIAMOND® artificial intelligence (AI) platform to improve drug discovery and development with a therapeutic focus on immuno-oncology, announces it has engaged in a strategic collaboration with Gemelli Teaching Hospital IRCCS to accelerate the analysis of the Company's first allogeneic CAR-T clinical trial candidate Alexis ISO-1.
Alexis ISO-1 is the Company's first artificial intelligence-identified, Gamma Delta T Cell engineered Iso-Mesothelin candidate to address solid tumor cancers.
Gemelli Teaching Hospital IRCCS (Gemelli) is a world-class university and cancer treatment and research center based in Rome, Italy. It is led by Professor Giovani Scambia, and is recognized as a Scientific Institute for Research, Hospitalization and Healthcare (IRCCS) for the disciplines of Personalized Medicine and Innovative Biotechnology and distinguishes itself in scientific areas of prestigious university research such as oncology.
"Gemelli is the very best possible European partner for Kiromic, as it has the ability to accelerate the analysis of our immune cell therapy candidate and shares our vision for improving cancer targeting through the use of bioinformatics and artificial intelligence," stated Maurizio Chiriva Internati, DBSc, PhDs, President, Chief Executive Officer, Chairman, and Founder of Kiromic BioPharma. "Gemelli is one of the leading immuno-oncology centers in Europe, and is led by Professor Scambia, who has more than 30 years in the immuno-oncology field, having written or contributed to more than 1,300 publications on this topic. We look forward to advancing this clinical partnership."
Professor Scambia, PhD, MD, commented, "We are pleased to have been selected to analyze Kiromic's off-the-shelf allogeneic CAR-T candidate. Our database of cancer tissue is one of the best in Europe for the types of cancer Kiromic is trying to treat, and our comprehensive cancer center foundation is extremely strong, built on significant research and development in the field of immunotherapy and live cell therapy."
Regulatory Guidance
The Company is anticipating being granted a Type A meeting with the FDA by the first half of 2022 to discuss the clinical hold and the clinical development path forward of its previously submitted IND. Following the Type A meeting, the Company plans to resubmit the investigational new drug (IND) application, and will continue to coordinate closely with the FDA to meet all regulatory requirements.
About Gemelli Teaching Hospital IRCCS
Founded in 1964 and dedicated to the memory and vision of Father Agostino Gemelli, Gemelli Teaching Hospital IRCCS is one of the most important and internationally acclaimed care providers in Italy. Gemelli Teaching Hospital IRCCS has been ensuring excellence in both diagnostics and therapy for fifty years: as an academic medical center operating in all areas of health and clinical assistance, it is at the heart of the Italian healthcare system. Gemelli Teaching Hospital IRCCS continues to evolve and innovate on the wings of its heritage and its ability to grasp change and look towards to the future: its operational model aims to integrate the care processes and all the hospital's activities, which are currently managed by 8 departments. More information can be found on their website.
About Kiromic BioPharma
Kiromic BioPharma, Inc. is an artificial intelligence-driven, end-to-end CAR-T and gene therapy company, developing the first multi-indication allogeneic CAR-T cell therapy, that exploits the natural potency of Gamma Delta T-cells to target solid cancers.
Kiromic BioPharma, Inc is 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 where big data science meets target identification in an effort to dramatically compress the man-years and billions of drug development dollars required 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 collaboration with Gemelli, including statements about expected benefits or progress of such collaboration, when we will be granted a Type A meeting with the FDA and our plans following any such meeting.
In some cases, you can identify forward-looking statements by terms such as "may," "in coming years," "could," "by," "if," "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 risks described in our filings with the Securities and Exchange Commission (SEC), including those discussed in our annual report on Form 10-K for the year ended December 31, 2020, in our quarterly reports on Form 10-Q for any subsequent quarterly periods, 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 report relate only to events or information as of the date on which the statements are made in this report. 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211011005172/en/
-
View Full Article Hide Full Article
Daniel Clark Appointed as Interim Chief Financial Officer
Mr. Clark Previously Served as Kiromic's Corporate Controller and Vice President of Finance Operations
Kiromic BioPharma, Inc. (NASDAQ:KRBP) ("Kiromic" or the "Company"), 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, announces it has appointed Daniel Clark as interim Chief Financial Officer ("CFO"), effective as of September 30, 2021.
Kiromic's previous CFO, Mr. Tony Tontat, resigned on September 29, 2021, effective immediately.
"It is a natural next step to appoint Dan Clark as Interim CFO, as he has been both Kiromic's Vice President of Finance Operations and our Corporate Controller. Dan has tremendous financial acumen and credentials, two critically important qualifications that I and the rest of our leadership team can attest to. We are delighted to appoint him to this role," stated Maurizio Chiriva Internati, DBSc, PhDs, Chief Executive Officer, Chairman and Founder of Kiromic BioPharma.
"I have enjoyed supporting our executive management team and our Board of Directors since joining the Company, and I'm excited to continue working alongside the team and overseeing the operation of Kiromic's finance and accounting organization. Further, I'm looking forward to facilitating the permanent CFO's seamless transition whenever he or she is identified," stated Mr. Clark.
Mr. Clark joined Kiromic in February 2020 and served as the Company's Corporate Controller until September 2021, when he was promoted to Vice President – Finance Operations. Before joining the Company, Mr. Clark was a Manager with The Siegfried Group, a national accounting services firm, from June 2018 to February 2020. Prior to his employment with The Siegfried Group, Mr. Clark served as Senior Consultant - Office of the CFO Solutions for FTI Consulting, a global financial consulting firm, from January 2017 to May 2018. Prior to that, Mr. Clark was Senior Associate - Audit at KPMG US, a member of Big Four global accounting firm KPMG, from August 2011 to June 2015. Mr. Clark holds a Master of Business Administration from Texas A&M University, Mays School of Business and a Bachelor of Science in Business Administration with a major in Accounting from the University of Richmond, Robins School of Business. Mr. Clark is a licensed Certified Public Accountant in the state of Texas.
About Kiromic BioPharma
Kiromic BioPharma, Inc. is an AI-driven, end-to-end CAR-T & gene therapy company, developing the first multi-indication allogeneic CAR-T cell therapy, that exploits the natural potency of Gamma Delta T-cells to target solid cancers.
Kiromic BioPharma, Inc 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211005006257/en/
-
View Full Article Hide Full Article
Kiromic Operating Highlights of 2Q-2021
Clinical Trials Updates
IND Applications
Re-Submissions of two IND applications for ALEXIS product candidates:
-- ALEXIS-PRO-1: Off-the-Shelf, Allogenic CAR-T expressing chPD1 for Solid Tumors (IV admin.)
-- ALEXIS-ISO-1: Off-the-Shelf, Allogenic CAR-T expressing Iso-Mesothelin for Solid Tumors (IV admin.)
Manufacturing GMP / CMC Validation
Appointed IQVIA, leading cell therapy and gene therapy, for clinical and regulatory support as part of Kiromic FDA Response Task Force.
Clinical Sites (CRO)
IQVIA, leading cell therapy and gene therapy CRO, is working to identify and onboard clinical sites across the USA and Europe.
Research and Development Updates
Research Grant Agreement for target validation in pancreatic cancer
MD Anderson: Dr. Robert Bresalier of MD Anderson is conducting a biomarker validation study for our AI Target Iso-Mesothelin in pancreatic cancer.
IP Filing
2 composition of matter patents were filed:
-- Mesothelin isoform binding molecules and chimeric PD1 receptor molecules, cells containing the same and uses thereof
-- Peptide compositions for the treatment of pathogenic infections
Key Management Updates
Chief Operations and Manufacturing Officer
Appointed Chief Operating and Manufacturing Officer, Ignacio Nunez who previously served as:
-- Executive Director of Manufacturing at the Gene Therapy Program at the University of Pennsylvania
-- Head of Manufacturing and Operations Excellence at Novartis
Chief Bioinformatics and Research Officer
Appointed Chief Bioinformatics and Research Officer, Michael Ryan, PhD. Michael Ryan, PhD. Dr. Ryan had previously been the head of InSilico Solutions, LLC, a leading AI vendor for large academic institutions.
Corporate Update
InSilico Solutions Membership Purchase Agreement
Continued investment in AI and machine learning with the Membership Purchase Agreement of InSilico Solutions, LLC.
Scientific and Investor Presentations
Scientific Innovator Conference
-- AACR 2021: 6 Scientific Posters Accepted for Presentation
-- Next-Gen Immuno Oncology Congress 2021
Investor Conference
Benzinga Global Small-cap Conference - Virtual Presentation
Kiromic BioPharma (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 quarterly results for the three and six months ended June 30, 2021, and provided an update on its corporate developments.
"Kiromic achieved important scientific and operational milestones during the first half of the year that we believe have us well positioned for preparing our staff and our facilities for the first in-human dosing during the first quarter of 2022," said Dr. Maurizio Chiriva-Internati, PhD, CEO and President of Kiromic BioPharma.
"We are thankful to our employees and collaborators who have maintained this high level of execution this year. From their efforts, we submitted two investigational new drug applications to the United States Food and Drug Administration in May 2021."
Our approach and goal are to defeat cancer by developing immunotherapies by improving target discovery and validation. With better targets, we believe our therapies will be more effective than the current array of immunotherapies using older targets.
Corporate and Scientific Highlights
Events that occurred during the three months ended June 30, 2021
-
Re-Submission of Two IND Applications - On May 17, 2021 and May 24, 2021, we announced re-submission of two investigational new drug ("IND") applications to the United States Food and Drug Administration. These INDs were for our ALEXIS-PRO-1 and ALEXIS-ISO-1 product candidates, respectively. ALEXIS-PRO-1 is our allogeneic gamma delta chimeric T cell therapy product candidate targeting PD-L1. ALEXIS-ISO-1 is our allogenic gamma delta CAR-T cell therapy product candidate targeting Isomesothelin (the isoform of Mesothelin).
Since re-submitting the INDs, the FDA returned with comments on our 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)
We have an FDA response taskforce, staffed with sufficient and appropriate personnel to prepare the response to the FDA. The company's plans to submit the prepared response by the first half of September 2021. The commencement of the dosing of its first in human clinical trial is expected to be delivered in the first quarter of 2022.- Appointment of Chief Operating and Manufacturing Officer – On June 7, 2021, we entered into an Executive Agreement with Mr. Ignacio Nunez to be our Chief Operating and Manufacturing Officer ("COMO"). The COMO will lead and manage the Company's functions/departments assigned by the CEO. The COMO will be responsible for the manufacturing function and will provide vision, leadership, and management to ensure we effectively and efficiently deliver research, clinical and commercial cell therapies. This position involves direct oversight and management of the manufacturing function to ensure the successful establishment of a new GMP facility and the commencement of manufacturing operations.
-
Membership Purchase Agreement with InSilico Solutions, LLC - On June 14, 2021, we entered into a Membership Interest Purchase Agreement (the "Purchase Agreement") with InSilico Solutions, LLC ("InSilico") and Michael Ryan (the "Seller") pursuant to which the Company acquired all of the outstanding membership interests of In Silico from the Seller for an aggregate purchase price of $540,000 (the "Purchase Price"). The Purchase Price is payable in full through (i) the delivery to the Seller of a number of shares of the Company's stock that is equal to $400,000 and (i) the delivery to the employees of In Silico of the Company's restricted stock units under the Company's 2021 Omnibus Equity Incentive Plan that is equal to $140,000.
InSilico is a bioinformatics services company that performs data analysis and software tool development for genome-wide research projects. Their headquarters is located in Fairfax, VA. InSilico performs contract research and collaborate on grant funded research with academic, government, and commercial organizations located throughout the United States.
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.
Events occurring after June 30, 2021 until August 13, 2021
-
Closing of Public Offering – On July 2, 2021, we received net proceeds of $37,121,200 from a public offering, after deducting underwriting discounts and commissions of $2,399,900 and other offering expenses of $478,900 incurred. The Company issued and sold 8,000,000 shares of common stock in the public offering at a price of $5.00 per share. In connection with the public offering, 400,000 representative warrants were issued with a price of $6.25 per share.
This public offering significantly strengthens the Company's balance sheet to support clinical trials for our 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 general corporate purposes.
- Completion of InSilico Acquisition – On July 26, 2021, we announced the completion of the InSilico acquisition.
- Communications with the FDA - Supported by IQVIA, instead of simply addressing the FDA's questions with a written response only (WRO), we took the decision to apply for a Type A meeting with the FDA. The Type A meeting will address the clinical hold issues and will allow us to discuss path toward our first-in-human dosing.
Q2 2021 Financial Highlights
Cash Position: Cash and cash equivalents were $3,070,400 as of June 30, 2021, compared to $10,150,500 as of December 31, 2020. The difference is attributable to cash outflows of $6,344,100, $590,600, and $145,400 for operating activities, investing activities, and financing activities respectively.
R&D Expenses: Our research and development expenses increased by $1,385,800, or 108.92%, to $2,658,100 for the three months ended June 30, 2021, from $1,272,300 for the three months ended June 30, 2020. Our research and development expenses increased by $2,243,300, or 97.52%, to $4,543,700 for the six months ended June 30, 2021, from $2,300,400 for the six months ended June 30, 2020. The increase was attributable to increased headcount, manufacturing, and experimentation costs for our ALEXIS-ISO-1 product candidate.
G&A Expenses: Our general and administrative expenses decreased by $7,780,500, or 77.08%, to $2,314,100 for the three months ended June 30, 2021 from $10,094,600 for the three months ended June 30, 2020. Our general and administrative expenses decreased by $6,534,100, or 59.54%, to $4,385,100 for the six months ended June 30, 2021 from $10,919,200 for the six months ended June 30, 2020. This decrease was primarily due to reduced stock compensation expenses.
Net Loss: Our net loss decreased to $8,928,800 during the six months ended June 30, 2021 compared to $13,219,600 during the six months ended June 30, 2020.
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. 333-257427) , originally filed with the Securities and Exchange Commission (SEC) on June 25, 2021, 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 report relate only to events or information as of the date on which the statements are made in this report. 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.
KIROMIC BIOPHARMA, INC.
Condensed Consolidated Balance Sheets
(Unaudited)
June 30,
December 31,
2021
2020
Assets
Current Assets:
Cash and cash equivalents
$
3,070,400
$
10,150,500
Prepaid expenses and other current assets
875,600
588,800
Total current assets
3,946,000
10,739,300
Property and equipment, net
2,468,700
2,066,000
Other assets
24,400
24,400
Total Assets
$
6,439,100
$
12,829,700
Liabilities and Stockholders' Equity:
Current Liabilities:
Accounts payable
$
1,124,100
$
665,200
Accrued expenses and other current liabilities
350,900
334,200
Interest payable
—
200
Loan payable
—
105,600
Note payable
91,600
362,400
Total current liabilities
1,566,600
1,467,600
Total Liabilities
1,566,600
1,467,600
Commitments and contingencies (Note 8)
Stockholders' Equity:
Common stock, $0.001 par value: 300,000,000 shares authorized as of June 30, 2021 and December 31, 2020; 7,387,500 shares and 7,332,999 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively
1,300
1,200
Additional paid-in capital
55,327,800
52,988,700
Accumulated deficit
(50,456,600
)
(41,627,800
)
Total Stockholders' Equity
4,872,500
11,362,100
Total Liabilities and Stockholders' Equity
$
6,439,100
$
12,829,700
KIROMIC BIOPHARMA, INC.
Condensed Consolidated Statements of Operations
(Unaudited)
Three Months Ended
Six Months Ended
June 30,
June 30,
2021
2020
2021
2020
Operating expenses:
Research and development
$
2,658,100
$
1,272,300
$
4,543,700
$
2,300,400
General and administrative
2,314,100
10,094,600
4,385,100
10,919,200
Total operating expenses
4,972,200
11,366,900
8,928,800
13,219,600
Loss from operations
(4,972,200
)
(11,366,900
)
(8,928,800
)
(13,219,600
)
Other income (expense)
Gain on loan extinguishment
—
—
105,800
—
Interest expense
(2,100
)
—
(5,800
)
—
Total other income (expense)
(2,100
)
—
100,000
—
Net loss
$
(4,974,300
)
$
(11,366,900
)
$
(8,828,800
)
$
(13,219,600
)
Net loss per share, basic and diluted
$
(0.68
)
$
(3.80
)
$
(1.21
)
$
(4.52
)
Weighted average common shares outstanding, basic and diluted
7,345,147
3,077,085
7,345,147
3,077,085
KIROMIC BIOPHARMA, INC.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
Six Months Ended
June 30,
2021
2020
Cash flows from operating activities:
Net loss
$
(8,828,800
)
$
(13,219,600
)
Adjustments to reconcile net loss to net cash used for operating activities:
Depreciation
202,400
68,500
Stock compensation expense
2,213,800
10,331,000
Gain on loan extinguishment
(105,800
)
—
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
151,500
(141,500
)
Accounts payable
41,800
291,000
Accrued expenses and other current liabilities
(19,000
)
66,800
Net cash used for operating activities
(6,344,100
)
(2,603,800
)
Cash flows from investing activities:
Purchases of property and equipment
(590,600
)
(762,300
)
Net cash used for investing activities
(590,600
)
(762,300
)
Cash flows from financing activities:
Repayments of note payable
(270,800
)
—
Exercise of stock options
125,400
—
Proceeds from warrant exercise
—
4,900
Proceeds from loan payable
—
115,600
Proceeds from Series B Preferred Stock issuance
—
3,000,000
Net cash (used for) provided by financing activities
(145,400
)
3,120,500
Net change in cash and cash equivalents
(7,080,100
)
(245,600
)
Cash and cash equivalents:
Beginning of year
10,150,500
1,929,100
End of period
$
3,070,400
$
1,683,500
Supplemental disclosures of non-cash investing and financing activities:
Accruals for property and equipment
$
14,500
$
45,000
Cash paid for interest on note payable
$
5,800
$
—
Accruals for deferred public offering costs
$
438,300
$
594,200
Warrants underlying Series B Preferred Stock issuance
$
—
$
2,668,300
View source version on businesswire.com: https://www.businesswire.com/news/home/20210813005386/en/
-
Re-Submission of Two IND Applications - On May 17, 2021 and May 24, 2021, we announced re-submission of two investigational new drug ("IND") applications to the United States Food and Drug Administration. These INDs were for our ALEXIS-PRO-1 and ALEXIS-ISO-1 product candidates, respectively. ALEXIS-PRO-1 is our allogeneic gamma delta chimeric T cell therapy product candidate targeting PD-L1. ALEXIS-ISO-1 is our allogenic gamma delta CAR-T cell therapy product candidate targeting Isomesothelin (the isoform of Mesothelin).