Kiromic BioPharma Reports Fiscal Year 2020 Financial Results and Continued Corporate Progress
Completion of
Longwood University Licensing Agreement of chPD1
Two IND Application Filings for chPD1, Isomesothelin,
GMP Facility Completion, Certification
“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
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
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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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Two IND Application Filings – On
December 17, 2020 we filed two applications with theU.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 inDecember 2020 , the Company has had communications with the FDA, and numerous consults with scientific board and clinical advisors regarding resubmission. InMarch 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.
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Longwood University Licensing Agreement – On
November 30, 2020 , we executed a licensing agreement for chPD1 withLongwood 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.
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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
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Net loss was
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
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
- 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
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
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2020 |
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2019 |
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Assets |
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Current Assets: |
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Cash and cash equivalents |
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$ |
10,150,500 |
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$ |
1,929,100 |
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Inventories |
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— |
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22,200 |
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Prepaid expenses and other current assets |
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588,800 |
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89,100 |
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Total current assets |
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10,739,300 |
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2,040,400 |
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Property and equipment, net |
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2,066,000 |
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587,900 |
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Other assets |
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24,400 |
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24,400 |
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Total Assets |
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$ |
12,829,700 |
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$ |
2,652,700 |
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Liabilities and Stockholders’ Equity: |
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Current Liabilities: |
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Accounts payable |
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$ |
665,200 |
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$ |
452,400 |
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Accrued expenses and other current liabilities |
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334,200 |
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221,300 |
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Interest payable |
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200 |
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— |
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Loan payable |
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105,600 |
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— |
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Note payable |
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362,400 |
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— |
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Total current liabilities |
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1,467,600 |
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673,700 |
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Total Liabilities |
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1,467,600 |
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673,700 |
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Commitments and contingencies (Note 9) |
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Stockholders’ Equity: |
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Series A‑1 Preferred Stock, |
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— |
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9,134,700 |
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Series B Preferred Stock, |
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— |
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1,306,900 |
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Preferred Stock, |
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— |
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— |
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Common stock, |
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1,200 |
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— |
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Additional paid-in capital |
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52,988,700 |
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13,965,000 |
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Accumulated deficit |
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(41,627,800 |
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(22,427,600 |
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Total Stockholders’ Equity |
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11,362,100 |
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1,979,000 |
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Total Liabilities and Stockholders’ Equity |
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$ |
12,829,700 |
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$ |
2,652,700 |
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Years Ended |
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2020 |
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2019 |
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Operating expenses: |
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Research and development |
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$ |
5,052,900 |
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$ |
1,201,700 |
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General and administrative |
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14,144,000 |
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2,503,700 |
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Total operating expenses |
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19,196,900 |
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3,705,400 |
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Loss from operations |
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(19,196,900 |
) |
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(3,705,400 |
) |
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Other expense |
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Interest expense |
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(3,300 |
) |
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(22,500 |
) |
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Total other expense |
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(3,300 |
) |
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(22,500 |
) |
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Net loss |
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$ |
(19,200,200 |
) |
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$ |
(3,727,900 |
) |
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Net loss per share, basic and diluted |
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$ |
(4.42 |
) |
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$ |
(1.39 |
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Weighted average common shares outstanding, basic and diluted |
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4,505,867 |
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2,862,809 |
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View source version on businesswire.com: https://www.businesswire.com/news/home/20210331005801/en/
Chief Financial Officer
628-777-3167
Bus.dev@kiromic.com
Source: