KRBP Kiromic BioPharma Inc.
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Kiromic achieves key milestone for this first in human phase 1 clinical trial
Kiromic Biopharma, Inc. (NASDAQ:KRBP)
Today, Kiromic announces the submission of a novel Investigational New Drug (IND) to the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial that has the potential to be a universal T-Cell therapy for any solid malignancy that expresses the biomarker PD-L1, with higher efficacy, higher safety, as well as lower manufacturing and distribution costs.
The clinical trial title: ALEXIS-PRO-1: A Phase 1, Open-label, Dose Escalation Study of KB-PD1, an Allogeneic Gamma Delta T-Cell Expressing a Chimeric PD1 Switch Receptor, in Subjects with PD‑L1 Positive Metastatic or Progressive Locally Advanced Solid Malignancies.
The FDA feedback is expected within 30 days from this IND submission.
Kiromic's preclinical studies show rapid and complete tumor elimination with no toxicity as per results presented at the American Association Cancer Research 2021 poster LB148.
Unlike in the case of autologous CAR-T cell therapy products, which are derived from pretreated cancer patients, Kiromic's proprietary PD1 Gamma-delta switch receptor therapy is derived from healthy donors.
Key features of the IND:
Product Name
KB-PD1
Product Type
Chimeric PD1 T-Cell live cell therapy
Cancer Type
All solid tumors
Targeting
Chimeric PD-L1
Patient Type
Patients with solid tumor positive for PD‑L1
Projected No. of Patients
30
Dosing
Dose escalation
Primary Completion of Trial
18 months
First-in-human dosing
3Q 2021 pending FDA authorization
First data from Trial
4Q 2021
How Our KB-PD1 Live T-Cell Therapy Improves CAR-T Market:
Marketed and traditional CAR-T
Kiromic KB-PD1
Malignancies
(Cancer Type)Hematologic
Solid Tumors
Live Cell Origin
Autologous
Live Cells from pre-treatment patients
Allogeneic
Live Cells from healthy donors
Live Cell Cloning
(Manufacturing)Single batch
Single doseSingle batch
Multi dose
(aka. Off-The-Shelf)
Mass Manufacturing
on-demand
a single patient-- Will be manufactured like a traditional drug
-- Kiromic proprietary manufacturing
-- Kiromic proprietary cryopreservation processing techniques
Kiromic was able to respect the expectations and meet the timeline 45 days before the end of the second quarter. Kiromic now expects that it will be able to deliver a first in human patient dosing by the end of Q3 2021. Kiromic, an organization that is driven to achieve scientific breakthroughs, dedicated significant resources to the IND submission in an effort to achieve the optimal clinical trial design.
Historically, checkpoint inhibitors have been successful in solid malignancies, but KB-PD1 takes it one step further by not just blocking the PD1/PD-L1 interaction ("cutting the brakes") like a checkpoint inhibitor does, but rather, KB-PD1 rewires the brake into an accelerator.
In this way, Kiromic is optimistic that any cancer cell that expresses the PD-L1 marker will effectively activate and accelerate the ability of KB-PD1 to traffic through the tumor microenvironment (TME), which thus far has proven to be an imposing barrier to effective T-cell treatments in solid cancers.
IQVIA (CRO, Clinical Research Organization)
IQVIA is an industry driver in data technology and advanced analytics, designed to produce and develop optimal clinical trial outcomes.
IQVIA will be managing our clinical trail sites CRO (Clinical Research Organization).
Leading global sites are lining up to be the first to dose our KB-PD1 live cell therapies for solid tumors.
Site announcements are coming within weeks.
CEO of Kiromic, Dr. Maurizio Chiriva-Internati, DBSc, PhDs
"I'm thrilled to see our technology go into the clinic, and it was due to the dedication of our team, and our strong preclinical results which helped propel Kiromic to be able to file this IND submission to the FDA on May 14, 2021," stated Dr. Maurizio Chiriva-Internati, DBSc, PhDs, CEO of Kiromic.
"Our people and vendors have been working tirelessly. They are excited and ready to launch the first-in-human dosing by 3Q 2021 pending FDA authorization.
Our KB-PD1 will be the first in the world to deliver this T-cell therapy to solid tumors with key features demanded by the T-cell therapy market. We aim to deliver KB-PD1 which will have:
-- Higher efficacy
-- Higher safety
-- Lower manufacturing costs
-- Lower distribution costs."
CFO of Kiromic, Mr. Tony Tontat
"This IND filing is an awaited news for the markets and will open up advantageous financing options to the company as we look to extend cash runway into 2022."
CSIO of Kiromic, Mr. Gianluca Rotino
"This IND filing is supported by strong IP portfolio including new IP in areas such as:
-- Gene editing
-- Live cell harvesting
-- Live cell expansion (manufacturing clones from small batches)
-- Live cell logistics (manufacturing, tissue preservation, and transfers)
As we continue to grow our DIAMOND derived targets and our related 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.
This is a key milestone, not only for Kiromic, positioning Kiromic as a pioneer in T-Cell therapy for solid tumors, but also for immunotherapy in general.
With the support of Kiromic's innovations in AI, the clinical trial R&D process will now be faster bringing cellular therapies to patients with more expediency than previously achievable."
CMO of Kiromic, Dr. Scott Dalhbeck
"Patients and clinicians alike have been waiting for a T-Cell therapy which could deliver a safe, effective, and lower cost solution for solid tumors. We are on the brink of making this vision a reality when we dose the first solid tumor patients."
About Metastatic Solid Malignancies
The ALEXIS-PRO-1 clinical trial will enroll patients with metastatic or progressive locally advanced solid malignancies that express the PD-L1 marker on their tumor.
These late-stage patients typically have a survival of only a few months, and so effective treatments that are non-toxic and rapidly effective, are desperately needed.
Since most solid malignancies express PD-L1, the dose escalation phase of the trial will be open to a wide range of tumor types such as prostate, breast, pancreas, lung, colon, renal, bladder, ovarian, and others.
Once the optimal biologic dose (OBD) has been determined, the OBD will then be given to an expanded number of patients for the most promising indications.
Since Kiromic's preclinical animal studies have shown a fast and brisk anti-tumor response, expectations are high that this product will be able to achieve what has thus far proven to be elusive with late-stage cancer patients – a significant and long-lasting improvement in the quality and quantity of life.
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.
The Company maintains its HQ offices in the world's largest medical center in Houston, Texas adjacent to MDAnderson Cancer Center and the Baylor College of Medicine where Kiromic has ongoing collaboration with these Institutions.
Kiromic's scientific achievements related to this endeavor can be seen in the six poster nominations awarded by the prestigious AACR at its annual meeting in April, 2021 (https://ir.kiromic.com/news-releases/news-release-details/kiromic-announces-6-posters-presented-american-association).
For more information, please visit the company's website at www.kiromic.com.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210517005496/en/
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Upcoming Investigational New Drug Application Submissions
Facility Expansion in Houston, TX
Leon Office, Asia, Strategic Marketing Agreement
SBA Loan Extinguishment
Research Grant Agreement with University of Texas MD Anderson Cancer Center
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 months ended March 31, 2021, and provided an update on its corporate developments.
"Kiromic BioPharma achieved important scientific and operational milestones during the year that we believe have us well positioned for preparing our staff and our facilities for the first in-human dosing in Q3 2021," 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 plan to submit two investigational new drug applications to the United States Food and Drug Administration by the end of 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 Occurring during the three months ended March 31, 2021
- Facility Expansion in Houston, TX - On March 22, 2021, we executed a lease expansion within our premises in Houston, TX. The amended lease agreement will commence on August 1, 2021 under an operating lease agreement that is noncancelable from commencement until May 1, 2024. The amended lease agreement adds approximately 15,385 square feet to the current facility. Total square feet will be approximately 38,223 square feet.
- Leon Office, Asia, Strategic Marketing Agreement – On January 28, 2021, we executed a strategic alliance agreement with Leon Office, Asia (H.K.) ("Leon") a company established under existing laws of Hong Kong. Leon will act as an independent business development advisor on the behalf of the Company. Leon will seek to introduce organizations and individuals that will create business development opportunities for the Company, to expand the Company's reach to international markets with a focus on certain Asian markets and to increase brand recognition and exposure through developing liaisons, collaborations, branches and subsidiaries. They will also use commercially reasonable efforts to research the Asian market, with a primary, but not exclusive, focus on determining the most suitable structures for the development of medical partnerships or joint ventures with scientific partners in the Asian market with a mission to test products to be created by the joint venture resulting from such partnership and to develop validation programs for any products produced by such joint venture, including programs for clinical trials and human testing and, ultimately, for product certification. The cost of the agreement is $360,000 annually, payable in four quarterly installments.
- SBA Loan Extinguishment - On February 16, 2021 the Small Business Administration ("SBA") granted forgiveness of our SBA loan and all applicable interest. On the date of forgiveness, the principal and accrued interest totaled $105,800. The forgiveness was classified as a gain on loan extinguishment in the consolidated statement of operations.
Events occurring after March 31, 2021 until May 14, 2021
- Research Grant Agreement with University of Texas MD Anderson Cancer Center – On April 8, 2021, we entered into a letter of intent (the "Letter of Intent") with the University of Texas MD Anderson Cancer Center ("MD Anderson") pursuant to which MD Anderson shall receive a research grant from us entitled, "Validation of biomarker isomeso for pancreatic cancer," which is aimed at discovering new cancer-specific antigen targets (the "Grant"). The total costs to us to be paid in connection with the Grant shall be $300,000. Pursuant to the Letter of Intent, the Grant shall commence on April 1, 2021 and end on March 31, 2022.
- Upcoming Investigational New Drug Application Submissions – We are planning to submit two investigational new drug ("IND") applications to the United States Food and Drug Administration by the end of May 2021. These INDs will be for our ALEXIS-PRO-1 and ALEXIS-ISO-1 product candidates. 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).
Q1 2021 Financial Highlights
Cash Position: Cash and cash equivalents were $7,335,300 as of March 31, 2021, compared to $10,150,500 as of December 31, 2020. The difference is attributable to cash outflows of $2,635,900, $44,700, and $134,600 for operating activities, investing activities, and financing activities respectively.
R&D Expenses: Our research and development expenses increased by $857,500, (83.41%), to $1,885,600 for the three months ended March 31, 2021. 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 increased by $1,246,400, (151.15%), to $2,071,000 for the three months ended March 31, 2021 from $824,600 for the three months ended March 31, 2020. This increase was primarily due to increased headcount, stock compensation expenses from prior year grant modifications, and professional services.
Net Loss: Our net loss increased to $3,854,500 during the three months ended March 31, 2021 compared to $1,852,700 during the three months ended March 31, 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 Annual Report on Form 10-K (file no. 001-39169), filed with the Securities and Exchange Commission on March 31, 2021, and elsewhere in this report. 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
March 31,
December 31,
2021
2020
Assets
Current Assets:
Cash and cash equivalents
$
7,335,300
$
10,150,500
Prepaid expenses and other current assets
513,500
588,800
Total current assets
7,848,800
10,739,300
Property and equipment, net
2,279,500
2,066,000
Other assets
24,400
24,400
Total Assets
$
10,152,700
$
12,829,700
Liabilities and Stockholders' Equity:
Current Liabilities:
Accounts payable
$
1,203,200
$
665,200
Accrued expenses and other current liabilities
268,900
334,200
Interest payable
—
200
Loan payable
—
105,600
Note payable
227,800
362,400
Total current liabilities
1,699,900
1,467,600
Total Liabilities
1,699,900
1,467,600
Commitments and contingencies (Note 8)
Stockholders' Equity:
Common stock, $0.001 par value: 300,000,000 shares authorized as of March 31, 2021 and December 31, 2020; 7,332,999 shares issued and outstanding as of March 31, 2021 and December 31, 2020
1,200
1,200
Additional paid-in capital
53,933,900
52,988,700
Accumulated deficit
(45,482,300
)
(41,627,800
)
Total Stockholders' Equity
8,452,800
11,362,100
Total Liabilities and Stockholders' Equity
$
10,152,700
$
12,829,700
KIROMIC BIOPHARMA, INC.
Condensed Consolidated Statements of Operations
Three Months Ended
March 31,
2021
2020
Operating expenses:
Research and development
$
1,885,600
$
1,028,100
General and administrative
2,071,000
824,600
Total operating expenses
3,956,600
1,852,700
Loss from operations
(3,956,600
)
(1,852,700
)
Other income (expense)
Gain on loan extinguishment
105,800
—
Interest expense
(3,700
)
—
Total other expense
102,100
—
Net loss
$
(3,854,500
)
$
(1,852,700
)
Net loss per share, basic and diluted
$
(0.53
)
$
(0.78
)
Weighted average common shares outstanding, basic and diluted
7,332,999
2,863,812
KIROMIC BIOPHARMA, INC.
Condensed Consolidated Statements of Cash Flows
Three Months Ended
March 31,
2021
2020
Cash flows from operating activities:
Net loss
$
(3,854,500
)
$
(1,852,700
)
Adjustments to reconcile net loss to net cash used for operating activities:
Depreciation
95,600
33,800
Stock compensation expense
945,200
456,000
Gain on loan extinguishment
(105,800
)
—
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
75,400
(99,700
)
Accounts payable
273,600
(35,200
)
Accrued expenses and other current liabilities
(65,400
)
17,500
Net cash used for operating activities
(2,635,900
)
(1,480,300
)
Cash flows from investing activities:
Purchases of property and equipment
(44,700
)
(406,300
)
Net cash used for investing activities
(44,700
)
(406,300
)
Cash flows from financing activities:
Repayments of note payable
(134,600
)
—
Proceeds from Series B Preferred Stock issuance
—
3,000,000
Net cash (used in) provided by financing activities
(134,600
)
3,000,000
Net change in cash and cash equivalents
(2,815,200
)
1,113,400
Cash and cash equivalents:
Beginning of year
10,150,500
1,929,100
End of period
$
7,335,300
$
3,042,500
Supplemental disclosures of non-cash investing and financing activities:
Accruals for property and equipment
$
264,400
$
230,700
Cash paid for interest on note payable
$
3,700
$
—
Warrants underlying Series B Preferred Stock issuance
$
—
$
2,668,300
View source version on businesswire.com: https://www.businesswire.com/news/home/20210514005463/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 its technology showcases at the recent American Association of Cancer Research ("AACR") 2021 meeting.
Kiromic BioPharma is using cutting-edge artificial intelligence (AI) technology to select biomarkers to develop CAR-T therapy for solid tumors.
The Company believes that the use of AI will enable it to compress development timelines in ways which are not achievable by its peers who are not equipped with AI technology.
The American Association of Cancer Research recognized Kiromic's innovation with its acceptance of 6 poster presentations at the recent conference on April 9-14, 2021.
Kiromic's 6 posters showcased the company's following technology platforms and advances:
- CancerDiff, a deep data mining engine that harmonizes billions of data points across disease types and states, data types, data structures and data platforms and Diamond AI, a proprietary system which combs through billions of transcription data points across public and private RNA databases to present the best immunogenic peptide candidates for CAR-T;
- CancerSplice, the Company's 3D, isoform prediction engine, which examines billions of data points to select the best targets;
- Validation of the Company's AI technology in identifying NY-ESO-1, which is a very well-known target and served as an excellent validation of the Company's engine's accuracy;
- Our company also demonstrated that our chPD1 receptor is effective on solid tumors in both in vitro and in vivo models with minimal toxicities;
- We showed that our non-viral gene edit technology could have the same target specificity of Cas9 without the DNA destruction common to HIV integrase;
- Finally we investigated NK as a potential adoptive cell therapy platform for CAR-T.
Dr. Maurizio Chiriva, PhD stated that, "Our mission is to become the leader in allogenic, off-the-shelf CAR-T in solid tumors. Our cutting-edge AI engine for biomarker identification and selection will support our development pathway going forward. We believe that our ability to deliver allogenic, off-the-shelf CAR-T for solid tumors is within reach and that our therapy will offer patients higher efficacy at lower costs. We expect to make this therapy a reality this year."
Mr. Gianluca Rotino, the Company's Chief Strategy and Innovation Officer, noted that, "We are proud to have set a new record for the number of posters accepted for a single company by the prestigious American Association of Cancer Research (AACR 2021), who accepted 6 of our posters. These poster presentations also broke ground for the number of new technologies that Kiromic is bringing to the world of live-cell therapy (CAR-T).
"We believe that we are disrupting the industry with our innovative approach as summarized in the following table:
Kiromic's approach
Industry standard
Targeting
AI driven and machine learning bio-informatics for targeting
Classic chemistry
Live Cell Type
Gamma Delta T cells for CAR-T
Peers' NK, or Mesenchymal (stem cells)
Donor Tissue Type
Allogenic gamma delta T cells from healthy donors
Marketed therapies' autologous T-cells from frail patients
Gene Editing
Non-viral, non-destructive to DNA
Industry standard CRISPR Cas9
GMP Manuf.
In-house Vivarium and GMP manufacturing for our clinical trials
Industry standard of using external Contract Manufacturers
"With these innovations, we believe that we are poised to lead the future for CAR-T in solid tumors. We expect to build on this lead with planned in-human dosing in the third quarter of 2021."
ABOUT KIROMIC POSTERS AT AACR 2021
Session
Focus
Poster
Link to Poster at AACR
BSB01.05
New Software for Data Analysis
247
CancerDiff:
Our deep data-mining engine which harmonizes billions of data points across:
-- disease types and states
-- data types,
-- data structures, and
-- data platforms.
Diamond AI:
Our system which combs through billions of transcription data points across public and private RNA databases to present the best immunogenic peptide candidates for CAR-T.
PO.IM02.01
Adoptive Cell Therapy
1534
Mesothelin isoform 2 is a novel target for allogenic CARγδT cell therapy in solid tumors
CancerSplice:
Our 3D, isoform prediction engine which examines billions of data points to select the best targets.
BSB01.04
New Algorithms
243
NY-ESO-1:
How we got to NY-ESO-1 using our AI target selection engine. NY-EOS-1 is a very well-known target and served as an excellent validation of our engine's accuracy.
PO.ET08.01
Gene and Vector-Based Therapy
1154
Site-specific gene editing with ABBIE for T-cell therapy
ABBIE:
We showed that our non-viral gene edit technology could have the same target specificity of Cas9 without the DNA destruction common to HIV integrase.
PO.IM02.01
Adoptive Cell Therapy
LB148
chPD1:
We demonstrated that our chPD1 receptor was effective on solid tumors in both in vitro and in vivo models with minimal toxicities.
PO.IM02.01
Adoptive Cell Therapy
1535
Allogenic CAR iNKT as a cell therapy platform targeting tumor antigen Isomesothelin
iNKT:
We investigated NK as a potential adoptive cell therapy platform for CAR-T.
About AACR (American Association of Cancer Research)
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 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 year ended December 31, 2020 filed 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210503005418/en/
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Completion of $15 million IPO
Longwood University Licensing Agreement of chPD1
Two IND Application Filings for chPD1, Isomesothelin, Allogeneic Gamma Delta, CAR-T Therapies
GMP Facility Completion, CertificationKiromic 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 financial results for the year ended December 31, 2020, and provided an update on its corporate developments.
"Kiromic BioPharma achieved important scientific and operational milestones during the year that we believe have us well positioned for preparing our staff and our facilities for the first in-human dosing in Q3 2021," 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."
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 array of immunotherapies using older targets.
Corporate and Scientific Highlights
-
Initial Public Offering Completion – On October 20, 2020, we completed our IPO, raising $15 million of gross proceeds, significantly strengthening the Company's balance sheet to support the continued development of our promising pipeline of targeted cancer therapies.
-
Two IND Application Filings – On December 17, 2020 we filed two applications with the U.S. Food and Drug Administration ("FDA"). The first IND was for a Phase 1 clinical trial of intravenously ("IV") administered allogeneic CAR-T for epithelial ovarian carcinoma ("EOC") and malignant pleural mesothelioma ("MPM"). The second IND was for a Phase 1 clinical trial of an intrapleural/intraperitoneal (IP) administered allogeneic CAR-T for EOC and MPM.
Since filing the original INDs in December 2020, the Company has had communications with the FDA, and numerous consults with scientific board and clinical advisors regarding resubmission. In March 2021, we announced that we planned to resubmit the two INDs.
The revised INDs will be for first in-human dosing of our Off-the-Shelf, Allogeneic Gamma-Delta T cell therapy for metastatic and progressive locally advanced solid malignancies.
The revised INDs have protocols which retain approximately 80% of the original INDs.
-
Longwood University Licensing Agreement – On November 30, 2020, we executed a licensing agreement for chPD1 with Longwood University. This 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, while making 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.
- GMP Facility Completion – As of September 30, 2020, the key features of the GMP facility have been completed, clearing the path for the production of off-the-shelf Gamma-Delta-T cells, a novel approach to CAR-T cell therapy, which will be evaluated in the upcoming clinical trials.
FY 2020 Financial Highlights
Cash Position: Cash and cash equivalents were $10,150,500 as of December 31, 2020, compared to $1,929,100 as of December 31, 2019. The increase was primarily due to cash inflows of $15,805,600 attributable to financing activities related to the issuance of common stock from the initial public offering, issuance of Series B Preferred Stock and proceeds net of repayments from the Paycheck Protection Program loan. These inflows were offset by outflows of $6,126,600 and $1,457,600 attributable to operating activities and investing activities, respectively.
R&D Expenses: Research and development expenses were $5,052,900 for the year ended December 31, 2020, compared to $1,201,700 for the year ended December 31, 2019. The increase was primarily attributable to augmented headcount, increased square footage to our Houston, TX leased facilities, in-vitro experimentation costs, and intellectual property costs.
G&A Expenses: General and administrative expenses were $14,144,000 for the year ended December 31, 2020, compared to $2,503,700 for the year ended December 31, 2019. This increase was primarily due to increased stock compensation expenses and personnel expenses.
Net Loss: Net loss was $19,200,200 for the year ended December 31, 2020, compared to a net loss of $3,727,900 for the year ended December 31, 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.
Consolidated Balance SheetsDecember 31,
December 31,
2020
2019
Assets
Current Assets:
Cash and cash equivalents
$
10,150,500
$
1,929,100
Inventories
—
22,200
Prepaid expenses and other current assets
588,800
89,100
Total current assets
10,739,300
2,040,400
Property and equipment, net
2,066,000
587,900
Other assets
24,400
24,400
Total Assets
$
12,829,700
$
2,652,700
Liabilities and Stockholders' Equity:
Current Liabilities:
Accounts payable
$
665,200
$
452,400
Accrued expenses and other current liabilities
334,200
221,300
Interest payable
200
—
Loan payable
105,600
—
Note payable
362,400
—
Total current liabilities
1,467,600
673,700
Total Liabilities
1,467,600
673,700
Commitments and contingencies (Note 9)
Stockholders' Equity:
Series A‑1 Preferred Stock, $0.0001 par value: 24,000,000 shares authorized as of December 31, 2020 and 2019; 0 and 21,822,301 shares issued and outstanding as of December 31, 2020 and 2019, respectively
—
9,134,700
Series B Preferred Stock, $0.0001 par value: 16,500,000 and 14,130,435 shares authorized as of December 31, 2020 and 2019, respectively; 0 and 9,869,659 shares issued and outstanding as of December 31, 2020 and 2019, respectively
—
1,306,900
Preferred Stock, $0.0001 par value: 19,500,000 and 21,869,565 shares authorized as of December 31, 2020 and 2019, respectively; 0 shares issued and outstanding as of December 31, 2020 and 2019
—
—
Common stock, $0.001 par value: 300,000,000 shares authorized as of December 31, 2020 and 2019; 7,332,999 and 2,863,812 shares issued and outstanding as of December 31, 2020 and 2019, respectively
1,200
—
Additional paid-in capital
52,988,700
13,965,000
Accumulated deficit
(41,627,800
)
(22,427,600
)
Total Stockholders' Equity
11,362,100
1,979,000
Total Liabilities and Stockholders' Equity
$
12,829,700
$
2,652,700
KIROMIC BIOPHARMA, INC.
Consolidated Statements of OperationsYears Ended
December 31,
2020
2019
Operating expenses:
Research and development
$
5,052,900
$
1,201,700
General and administrative
14,144,000
2,503,700
Total operating expenses
19,196,900
3,705,400
Loss from operations
(19,196,900
)
(3,705,400
)
Other expense
Interest expense
(3,300
)
(22,500
)
Total other expense
(3,300
)
(22,500
)
Net loss
$
(19,200,200
)
$
(3,727,900
)
Net loss per share, basic and diluted
$
(4.42
)
$
(1.39
)
Weighted average common shares outstanding, basic and diluted
4,505,867
2,862,809
View source version on businesswire.com: https://www.businesswire.com/news/home/20210331005801/en/
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Initial Public Offering Completion – On October 20, 2020, we completed our IPO, raising $15 million of gross proceeds, significantly strengthening the Company's balance sheet to support the continued development of our promising pipeline of targeted cancer therapies.
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Kiromic BioPharma, Inc. (Nasdaq: KRBP) is an immuno-oncology target discovery and gene-editing company with a proprietary artificial intelligence neural network platform (Diamond AI) to develop novel oncology therapeutics.
Today, the Company announced an interview with the CEO, Dr. Maurizio Chiriva-Internati, which will air on The RedChip Money Report on the Bloomberg Network.
The CEO Interview will air on Bloomberg Television at the time slot below:
Across the United States
Saturday, March 27 at 7 p.m. local time
The CEO interview will cover these subjects:
-- IND filing timelines
-- IND expanded indications
-- GMP manufacturing updates
The RedChip Money Report airs on Bloomberg Television U.S. on Saturdays at 7 p.m. local time, reaching up to 73 million homes.
To view the interview segment, please visit https://youtu.be/Wg8Z6Ixmdi4.
"The RedChip Money Report" delivers insightful commentary on small-cap investing, interviews with Wall Street analysts, financial book reviews, as well as featured interviews with executives of public companies.
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 in Houston, TX adjacent to the world's largest medical center and the MD Anderson Cancer Center. For more information, please visit 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 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/20210326005290/en/