Recent Corporate Highlights Include:
- New Leadership Appointed at the Company, Board
of Director Level
- Completed Studies to Further Optimize Potency
and Validity of the ALEXIS Gamma Delta T (GDT) Cell Platform
- Progressed a Master Cell Bank Strategy for
Retro-viral Vector (RVV) Production
- Enhanced Kiromic’s Diamond AI™ Mediated Pooled
Donor Gamma Delta T Cell Banking Technology
- Expansion and Redesign of In-house cGMP
Manufacturing Facility
- DIAMOND®AI 2.0 New Component NOEMI
(NeurO Evolutive) Machine Learning
Enabled Antibody Design) Designed to Dramatically Reduce Time and
Cost of CAR-T Cell Therapy Development
- Cash Position $15,123,100 as of March 31,
2022
Kiromic BioPharma, Inc. (NASDAQ: KRBP) (“Kiromic” or the
“Company”), a clinical-stage fully integrated biotherapeutics
company using its proprietary DIAMOND® artificial intelligence (AI)
and data mining platform to discover and develop cell and gene
therapies with a therapeutic focus on immuno-oncology, today
announces financial results for the first quarter ended March 31,
2022.
“This past quarter has seen tremendous progress inside the
Company, particularly within the research, development, and
manufacturing functions. As an organization, we have achieved
important goals, from optimizing and validating our ALEXIS Gamma
Delta T (GDT) cell platform, enhancing our GDT cell banking
technology, to expanding and redesigning our cGMP manufacturing
facility and deploying a master cell bank strategy. These are all
critical activities for achieving our milestone of beginning the
activation of the clinical trial for our first oncology cell
therapy candidate Procel™ by the end of the fourth quarter later
this year,” stated Pietro Bersani, Kiromic BioPharma’s Chief
Executive Officer. “We have been intensely preparing for this
milestone, and we believe that we now have the right team, the
right capabilities, and the right processes in place to achieve
this objective. We have a tremendous opportunity ahead of us, with
incredible science that we are looking forward to ultimately making
available to patients.”
Quarter 1 Fiscal Year 2022 Financial Highlights:
- Cash Position: Cash and cash equivalents were
$15,123,100 as of March 31, 2022, compared to $25,353,900 as of
December 31, 2021. The difference is attributable to cash outflows
of $7,520,200, $2,541,800, and $168,800 for operating, investing,
and financing activities, respectively.
- R&D Expenses: Our research and development expenses
increased by $1,040,200, or 55.17%, to $2,925,800 for the three
months ended March 31, 2022, from $1,885,600 for the three months
ended March 31, 2021. The increase was attributable to increased
headcount, manufacturing, and experimentation costs for the
development of our ALEXIS clinical platform.
- G&A Expenses: Our general and administrative
expenses increased by $2,368,200, or 114.35%, to $4,439,200 for the
three months ended March 31, 2022, from $2,071,000 for the three
months ended March 31, 2021. This increase was primarily due to
increases in professional services fees, personnel, and recruiting
costs.
- Net Loss: Our net loss increased to $7,019,400 during
the three months ended March 31, 2022, compared to $3,854,500
during the three months ended March 31, 2021.
Recent Business Highlights:
New Company Leadership:
- As previously announced, we appointed our Chief Executive
Officer, a new Chair of our Board, and two new independent Board
members.
ALEXIS (Gamma Delta CAR-T cell Platform) Research &
Development:
- Continued to improve and enhance the manufacturing efficiencies
of the ALEXIS platform, optimizing both cellular function and cost
containment
- Progressed a Master Cell Bank strategy for retro-viral vector
(RVV) production
- Performed additional studies on supplementary target tumor cell
lines, thereby providing additional pre-clinical validation of the
potency and specificity of the ALEXIS platform of products.
- Further optimized Kiromic’s Diamond AI™mediated pooled donor
Gamma Delta T cell banking technology. The method of manufacturing
GDT cells from pooled allogenic donors has been validated and
confirmed with post-freezing, thawing, recovery, stability, and
potency. As a next step, the pooled donor GDT cell banks will be
tested in vivo for tolerability and efficacy.
- Confirmed a quantitative methodology to determine the residual
helper plasmid DNA in RVV preparations, which is an important RVV
release test used in manufacturing Procel™ and Isocel™.
cGMP Manufacturing:
- We have expanded and redesigned our in-house current Good
Manufacturing Practices (cGMP) facility.
DIAMOND®AI 2.0 Platform for Drug Discovery and
Development: NOEMI (NeurO Evolutive) Machine Learning
Enabled Antibody Design)
- Kiromic’s DIAMOND®AI 2.0 identifies and validates
cancer-specific proteins on the surface of cancer cells that can be
targeted by engineered T-cells. Typically, a year of laboratory
work in animal models and significant expense is then required to
develop a chimeric antigen receptor (CAR) for our GDT cells so they
will attack that cancer target.
- Consistent with Kiromic’s mission to apply cutting edge
techniques to improve immunotherapy, we believe we have created a
groundbreaking system, NOEMI, to dramatically accelerate CAR
development.
- NOEMI is a machine learning and genetic algorithm trained to
provide the sequence of a chimeric antigen receptor (CAR) receptor
that will bind a Diamond AI target. This software can do in hours
what would normally take a year.
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 ALEXIS, a
multi-indication allogeneic CAR-T cell therapy platform 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 data science meets target identification
to dramatically compress the 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.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that
involve substantial risks and uncertainties. Kiromic makes such
forward-looking statements pursuant to the safe harbor provisions
of the United States 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. In some cases,
you can identify forward-looking statements by terms such as:
“will,” “potential,” “could,” “can,” “believe,” “intends,”
“continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,”
or the negative of these terms or other comparable terminology.
These forward-looking statements include, but are not limited to,
statements regarding: Kiromic’s future financial performance,
Kiromic’s ability to achieve its objectives, including the
activation of its clinical trials; timing of the Company’s clinical
trials; and the timing for the initiation and successful completion
of Kiromic’s clinical trials of its product candidates. These
forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause actual results,
levels of activity, performance or achievements to be materially
different from the information expressed or implied expressed or
implied by these forward-looking statements. These risks and
uncertainties include, but are not limited to, the risks and
uncertainties discussed in our Annual Report on Form 10-K for the
year ended December 31, 2021 and as detailed from time to time in
our SEC filings. You should not rely upon forward-looking
statements as predictions of future events. Although we believe
that the expectations reflected in the forward-looking statements
are reasonable, we cannot guarantee that the future results, levels
of activity, performance, or events and circumstances reflected in
the forward-looking statements will be achieved or occur. Moreover,
neither we nor any other person assumes responsibility for the
accuracy and completeness of the forward-looking statements. Such
forward-looking statements relate only to events as of the date of
this press release. We undertake no obligation to update any
forward-looking statements except to the extent required by
law.
KIROMIC BIOPHARMA,
INC.
Condensed Consolidated Balance
Sheets
(Unaudited)
March 31,
December 31,
2022
2021
Assets
Current Assets:
Cash and cash equivalents
$
15,123,100
$
25,353,900
Accounts receivable
—
16,200
Prepaid expenses and other current
assets
1,607,900
1,699,400
Total current assets
16,731,000
27,069,500
Property and equipment, net
6,900,400
3,629,000
Operating lease right-of-use asset
2,227,300
—
Other assets
31,100
31,100
Total Assets
$
25,889,800
$
30,729,600
Liabilities and Stockholders’
Equity:
Current Liabilities:
Accounts payable
$
1,995,600
$
2,214,300
Accrued expenses and other current
liabilities
1,343,600
741,000
Note payable
285,700
454,500
Operating lease liability - short term
480,300
—
Total current liabilities
4,105,200
3,409,800
Deferred rent
5,500
—
Operating lease liability - long term
1,747,000
—
Total Liabilities
5,857,700
3,409,800
Commitments and contingencies (Note 8)
Stockholders’ Equity:
Common stock, $0.001 par value:
300,000,000 shares authorized as of March 31, 2022 and December 31,
2021; 15,585,587 shares and 15,488,516 shares issued and
outstanding as of March 31, 2022 and December 31, 2021,
respectively
9,300
9,300
Additional paid-in capital
94,607,100
94,527,000
Accumulated deficit
(74,584,300
)
(67,216,500
)
Total Stockholders’ Equity
20,032,100
27,319,800
Total Liabilities and Stockholders’
Equity
$
25,889,800
$
30,729,600
KIROMIC BIOPHARMA, INC.
Condensed Consolidated
Statements of Operations
(Unaudited)
Three Months Ended
March 31,
2022
2021
Operating expenses:
Research and development
$
2,925,800
$
1,885,600
General and administrative
4,439,200
2,071,000
Total operating expenses
7,365,000
3,956,600
Loss from operations
(7,365,000
)
(3,956,600
)
Other income (expense)
Gain on loan extinguishment
—
105,800
Interest expense
(2,800
)
(3,700
)
Total other income (expense)
(2,800
)
102,100
Net loss
$
(7,367,800
)
$
(3,854,500
)
Net loss per share, basic and diluted
$
(0.48
)
$
(0.53
)
Weighted average common shares
outstanding, basic and diluted
15,542,444
7,332,999
KIROMIC BIOPHARMA,
INC.
Condensed Consolidated
Statements of Cash Flows
(Unaudited)
Three Months Ended
March 31,
2022
2021
Cash flows from operating activities:
Net loss
$
(7,367,800
)
$
(3,854,500
)
Adjustments to reconcile net loss to net
cash used for operating activities:
Depreciation
182,800
95,600
Stock compensation expense
80,100
945,200
Gain on loan extinguishment
—
(105,800
)
Changes in operating assets and
liabilities
Accounts receivable
16,200
—
Prepaid expenses and other current
assets
91,500
75,400
Operating lease right-of-use asset
(2,227,300
)
—
Accounts payable
(1,189,800
)
273,600
Accrued expenses and other current
liabilities
602,600
(65,400
)
Deferred rent
5,500
—
Operating lease liability
2,227,300
—
Net cash used for operating
activities
(7,578,900
)
(2,635,900
)
Cash flows from investing activities:
Purchases of property and equipment
(2,483,100
)
(44,700
)
Net cash used for investing
activities
(2,483,100
)
(44,700
)
Cash flows from financing activities:
Repayments of note payable
(168,800
)
(134,600
)
Net cash used for financing
activities
(168,800
)
(134,600
)
Net change in cash and cash
equivalents
(10,230,800
)
(2,815,200
)
Cash and cash equivalents:
Beginning of year
25,353,900
10,150,500
End of period
$
15,123,100
$
7,335,300
Supplemental disclosures of non-cash
investing and financing activities:
Accruals for property and equipment
$
971,100
$
264,400
Cash paid for interest on note payable
$
2,800
$
3,700
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220513005108/en/
Linda Phelan Dyson, MPH Global Head, Corporate Communications
ldyson@kiromic.com M: 281-468-7683
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