- Provisional patent filing titled, “Mesothelin Isoform
Binding Molecules and Uses Thereof”
- Completed external validation of clinical samples of key
Isoform Mesothelin targets
- Completed Construction of Vivarium and Clean Room
Facilities at the Houston Offices
Kiromic BioPharma (“the Company”) (NASDAQ: KRBP), a
pre-clinical stage biotechnology company using its proprietary
DIAMOND® artificial intelligence (“A.I.”) platform to improve drug
discovery and development with a therapeutic focus on
immune-oncology, today announced its financial results for the
third quarter ended September 30, 2020, and provided an update on
its corporate developments.
“Kiromic BioPharma achieved important scientific and operational
milestones during the quarter that have us well positioned for
growth as we focus on being the leader in A.I.-enabled
immune-oncology drug development,” said Dr. Maurizio
Chiriva-Internati, CEO and President of Kiromic BioPharma. “We are
thankful to our employees and collaborators who have maintained
this high level of execution in the middle of the hard challenges
posed by the COVID-19 pandemic. Through their efforts, as of today
nothing has come to our attention causing us to believe that we are
not poised to file our two INDs for Epithelial Ovarian Cancer
during 4Q-2020. The first IND will be our chimeric PD1 for ovarian
cancer, and the second IND will be our isoform mesothelin in
ovarian cancer.”
Subsequent to the quarter end, on October 20, 2020, we completed
a successful IPO, raising gross proceeds of $15,000,000,
significantly strengthening the Company’s balance sheet to support
the continued development of our promising pipeline of targeted
cancer therapies. Our approach and goal is to defeat cancer by
developing immunotherapies that rely on improving target discovery
and validation. With better targets, we believe our therapies will
be more effective than the current crop of immunotherapies using
older targets.
Corporate and Scientific Highlights
- Intellectual Property Application Filing – Kiromic
BioPharma (“The Company”) filed a United States provisional patent
application on July 6, 2020, entitled "Mesothelin Isoform Binding
Molecules and Uses Thereof,” that discloses engineered gamma-delta
T cells containing mesothelin isoform-directed molecules. This
provisional application is expected to expire on July 7, 2021, and
the Company plans to file at least an international PCT patent
application claiming priority to the provisional application before
it expires. The Company plans to build at least one patent family
directed to engineered allogeneic effector cells, in support of its
development of off-the-shelf allogeneic immunotherapy treatments to
patients with indications of Isoform Mesothelin Epithelial Ovarian
Cancer, and Isoform Mesothelin Malignant Pleural Mesothelioma.
- External Validation of Targets - The Company completed
external validation of Isoform Mesothelin targets including
mesothelioma, ovarian cancer, and pancreatic cancer during the 3
months ended September 30, 2020.
- Clean Rooms and Vivarium Facility Construction
Completion - The Company completed construction of an $820,000
leasehold improvement located at the Houston, TX based offices. The
asset contains a current Good Lab Practices (“cGLP”) Vivarium
Facility, and current Good Manufacturing Practices (“cGMP”) Clean
Rooms for clinical manufacturing. The cGLP Vivarium is currently
being used to perform key in vivo non-clinical research to support
the Company’s clinical initiatives through an Initial New Drug
(“IND”) filing with the FDA. The cGMP suite consists of 5 clean
rooms which will be used to manufacture the Company’s off-the-shelf
allogeneic therapies during clinical trials. Management plans to
commence clinical trials only if IND applications are approved by
the FDA.
Q3 2020 Financial Highlights
Cash Position: Cash and cash equivalents were $469,300 as
of September 30, 2020, compared to $1,929,100 as of December 31,
2019. The decrease was primarily due to cash outflows of $3,557,200
and $1,013,100 attributable to operating activities and investing
activities, respectively. The offsetting cash inflows of $3,110,500
was attributed to financing activities related to the Company’s
Series B Preferred Stock issuance along with proceeds net of
repayments from the Paycheck Protection Program loan.
R&D Expenses: Research and development expenses were
$1,225,700 for the quarter ended September 30, 2020, compared to
$272,100 for the quarter ended September 30, 2019. The increase was
primarily attributable to augmented headcount, increased square
footage to our Houston, TX leased facilities, and in-vitro
experimentation costs.
G&A Expenses: General and administrative expenses
were $1,190,000 for the quarter ended September 30, 2020, compared
to $607,400 for the quarter ended September 30, 2019. This increase
was primarily due to personnel expenses.
Net Loss: Net loss was $2,415,700 for the quarter ended
September 30, 2020, compared to a net loss of $886,900 for the
quarter ended September 30, 2019.
Dr. Chiriva-Internati continued, “Developing live-cell therapies
by leveraging artificial intelligence is central to transforming
the cost and efficiency of the immune-oncology field and improving
the potential for off-the-shelf therapies for cancer patients. We
believe our approach will help us design more efficient
pre-clinical validation studies and more targeted clinical trials,
thereby accelerating our drug candidates’ time to approval and
eventually to market. DIAMOND is central to our process in
achieving this outcome rapidly and with reduced costs,” concluded
Dr. Chiriva-Internati.
About Kiromic BioPharma
Kiromic BioPharma, Inc. is a preclinical stage biopharmaceutical
company which is focused on discovering, developing, and
commercializing novel immune-oncology applications through its
robust product pipeline, which are in the pre-IND validation stages
of the United States Food and Drug Administration clinical trial
process. The pipeline development is leveraged through the
Company’s proprietary target discovery engine called "DIAMOND."
Kiromic's DIAMOND is big data science meeting target
identification, dramatically compressing man-years and billions of
drug development dollars to develop a live drug. The Company
maintains offices in Houston, Texas. The Company has not generated
any revenues to date. For more information, please visit the
company’s website at www.kiromic.com.
Forward-looking Statements
This press release contains forward-looking statements that
involve substantial risks and uncertainties. We make such
forward-looking statements pursuant to the safe harbor provisions
of the U.S. Private Securities Litigation Reform Act, Section 21E
of the Securities Exchange Act of 1934, as amended, and other
federal securities laws. All statements other than statements of
historical facts are forward-looking statements. These statements
relate to future events or to our future financial performance and
involve known and unknown risks, uncertainties and other factors
that may cause our actual results, levels of activity, performance
or achievements to be materially different from any future results,
levels of activity, performance or achievements expressed or
implied by these forward-looking statements. Forward-looking
statements include, but are not limited to, statements about:
- our goals and strategies;
- our future business development, financial condition and
results of operations;
- expected changes in our revenue, costs or expenditures;
- growth of and competition trends in our industry;
- our expectations regarding demand for, and market acceptance
of, our products;
- our expectations regarding our relationships with investors,
institutional funding partners and other parties we collaborate
with;
- fluctuations in general economic and business conditions in the
markets in which we operate; including those fluctuations caused by
COVID-19; and
- relevant government policies and regulations relating to our
industry.
In some cases, you can identify forward-looking statements by
terms such as “may,” “could,” “will,” “should,” “would,” “expect,”
“plan,” “intend,” “anticipate,” “believe,” “estimate,” “predict,”
“potential,” “project” or “continue” or the negative of these terms
or other comparable terminology. These statements are only
predictions. You should not place undue reliance on forward-looking
statements because they involve known and unknown risks,
uncertainties and other factors, which are, in some cases, beyond
our control and which could materially affect results. Factors that
may cause actual results to differ materially from current
expectations include, among other things, those listed under the
heading “Risk Factors” included in our Registration Statement on
Form S-1 (file no. 333-238153) , originally filed with the
Securities and Exchange Commission (SEC) on May 11, 2020, as
amended, and elsewhere in this press release. If one or more of
these risks or uncertainties occur, or if our underlying
assumptions prove to be incorrect, actual events or results may
vary significantly from those implied or projected by the
forward-looking statements. No forward-looking statement is a
guarantee of future performance.
The forward-looking statements made in this press release relate
only to events or information as of the date on which the
statements are made in this press release. Except as expressly
required by the federal securities laws, there is no undertaking to
publicly update or revise any forward-looking statements, whether
as a result of new information, future events, changed
circumstances or any other reason. You are advised, however, to
review any further disclosures we make on related subjects in our
subsequent Forms 10-Q, 8-K and other reports filed with the
SEC.
KIROMIC BIOPHARMA,
INC.
Condensed Consolidated Balance
Sheets
(Unaudited)
September 30,
December 31,
2020
2019
Assets
Current Assets:
Cash and cash equivalents
$
469,300
$
1,929,100
Inventories
22,200
22,200
Prepaid expenses and other current
assets
1,051,900
89,100
Total current assets
1,543,400
2,040,400
Property and equipment, net
1,612,300
587,900
Other assets
24,400
24,400
Total Assets
$
3,180,100
$
2,652,700
Liabilities and Stockholders’
Equity:
Current Liabilities:
Accounts payable
$
1,672,900
$
452,400
Accrued expenses and other current
liabilities
473,000
221,300
Loan payable
105,600
—
Total current liabilities
2,251,500
673,700
Total Liabilities
2,251,500
673,700
Commitments and contingencies (Note 8)
Stockholders’ Equity:
Series A‑1 Preferred Stock, $0.0001 par
value: 24,000,000 shares authorized as of September 30, 2020 and
December 31, 2019; 21,822,301 shares issued and outstanding as of
September 30, 2020 and December 31, 2019
9,134,700
9,134,700
Series B Preferred Stock, $0.0001 par
value: 16,500,000 and 14,130,435 shares authorized as of September
30, 2020 and December 31, 2019, respectively; 16,391,397 and
9,869,659 shares issued and outstanding as of September 30, 2020
and December 31, 2019, respectively
2,331,300
1,306,900
Preferred Stock, $0.0001 par value:
19,500,000 and 21,869,565 shares authorized as of September 30,
2020 and December 31, 2019, respectively; 0 shares issued and
outstanding as of September 30, 2020 and December 31, 2019
—
—
Common stock: 300,000,000 shares
authorized as of September 30, 2020 and December 31, 2019;
4,989,269 and 2,863,812 shares issued and outstanding as of
September 30, 2020 and December 31, 2019, respectively
—
—
Additional paid-in capital
27,525,500
13,965,000
Accumulated deficit
(38,062,900
)
(22,427,600
)
Total Stockholders’ Equity
928,600
1,979,000
Total Liabilities and Stockholders’
Equity
$
3,180,100
$
2,652,700
KIROMIC BIOPHARMA,
INC.
Condensed Consolidated
Statements of Operations
(Unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2020
2019
2020
2019
Operating expenses:
Research and development
$
1,225,700
$
272,100
$
3,526,100
$
601,500
General and administrative
1,190,000
607,400
12,109,200
934,300
Total operating expenses
2,415,700
879,500
15,635,300
1,535,800
Loss from operations
(2,415,700
)
(879,500
)
(15,635,300
)
(1,535,800
)
Other expense
Interest expense
—
(7,400
)
—
(22,400
)
Total other expense
—
(7,400
)
—
(22,400
)
Net loss
$
(2,415,700
)
$
(886,900
)
$
(15,635,300
)
$
(1,558,200
)
Net loss per share, basic and diluted
$
(0.65
)
$
(0.32
)
$
(4.39
)
$
(0.55
)
Weighted average common shares
outstanding, basic and diluted
3,719,132
2,862,523
3,719,132
2,862,523
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201130005939/en/
Tony Tontat Chief Financial Officer 628-777-3167
Bus.dev@kiromic.com
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