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,
Certification
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 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 Sheets
December 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 Operations
Years 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/
Tony Tontat Chief Financial Officer 628-777-3167
Bus.dev@kiromic.com
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