Kiromic BioPharma Reports Fourth Quarter and Full-Year 2021 Financial Results and Recent Corporate Highlights
Highlights Include Company’s Progress in the Following Areas:
- Advances in the Research, Development, and Manufacturing Processes of the ALEXIS Gamma Delta T cell Platform
-
Key Hires in Research & Development, Clinical Translational Medicine and Clinical Trial Preparation
- Completion of Approximately 90% of In-house cGMP Facility Expansion and Redesign
- Launch of DIAMOND® Artificial Intelligence (AI) 2.0 Platform for Identification and Selection of Immunotherapy Targets, which Now Includes Nearly Two Billion Data Points
“We are extremely encouraged by the progress the Company demonstrated in the fourth quarter. Our team’s unified efforts are strictly focused on achieving our goal of beginning the activation of the clinical trial for our first oncology cell therapy candidate by the end of the fourth quarter of 2022,” stated
Fiscal Year Ended 2021 Financial Highlights:
-
Cash Position: Cash and cash equivalents were
$25,353,900 as ofDecember 31, 2021 , compared to$10,150,500 as ofDecember 31, 2020 . The difference is attributable to cash outflows of$20,321,500 , and$1,810,800 for operating activities, and investing activities, respectively. There were cash inflows of$37,335,700 from financing activities.
-
R&D Expenses: Our research and development expenses increased by
$6,314,900 , or 124.98%, to$11,367,800 for the year endedDecember 31, 2021 from$5,052,900 for the year endedDecember 31, 2020 . 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 decreased by
$206,100 , or 1.46%, to$13,937,900 for the year endedDecember 31, 2021 from$14,144,000 for the year endedDecember 31, 2020 . This decrease was primarily due to reduced stock compensation expenses, offset by increases in professional services fees, personnel, and recruiting costs.
-
Net Loss: Our net loss increased to
$25,588,700 during the year endedDecember 31, 2021 compared to$19,200,200 during the year endedDecember 31, 2020 .
Recent Business Highlights:
ALEXIS (Gamma Delta CAR-T cell Platform) Research & Development:
- Developed an innovative and highly efficient process that improves the manufacturing of our cell therapy candidates, making it more space-efficient and cost-effective. We believe that this will significantly reduce the costs of CAR-T cell manufacturing, providing a competitive market advantage.
- Successfully tested a prototype variant of the ALEXIS manufacturing process that leverages the potential of pooled donors’ cells. This is a necessary step to building a proprietary bank of precursor cells for the manufacturing of our ALEXIS product line. A donor cell bank is expected to ensure a high degree of homogeneity and consistency of our drug products, and at the same time to improve the resilience of our supply chain.
- Continued progress towards a scalable and retrovirus-free process for the delivery of recombinant genes into T cells. This is an important step towards the deployment of our proprietary non-viral cell engineering system.
-
The Company added new hires across the organization, specifically augmenting research & development, clinical translational medicine and clinical trial preparation capabilities. This represents a headcount total of nearly 60 employees, which is an increase from 19 as of
December 31, 2020 .
cGMP Manufacturing:
- We have completed approximately 90% of our in-house current Good Manufacturing Practices (cGMP) facility expansion and redesign.
DIAMOND®AI 2.0 Platform for Drug Discovery and Development is Completed:
-
The Company developed and made operational a completely revised version of its proprietary platform for identification and vetting of immunotherapy targets. Diamond AI 2.0 was developed by Kiromic’s in-house bioinformatics team and includes:
- Enhanced and updated existing models to provide more accurate predictions of therapy target efficacy;
- A modular, containerized architecture to support rapid addition of new algorithms, scientific methods, and therapy designs;
- Integrated data mining components to provide a seamless workflow from identification of cancer-specific surface protein regions through to vetted immunotherapy targets;
- Proteomic validation of transcript targets;
- An additional 300+ million data points were added to the DIAMOND database in Q4 2021, which included proteomic data covering and extending the range of cancer types; and
- Approximately 600 million data points were added in 2021, representing a 50% data point increase from 2020.
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;
- our expected timing of human clinical trials and other related milestones;
- difficulties or delays in the product development process, including the results of preclinical studies or clinical trials;
- difficulties or delays in the regulatory approval process;
- manufacturing, sales, marketing and distribution of any of our products that may be successfully developed and approved for commercialization;
- growth of and competition trends in our industry;
- our expectations regarding demand for, and market acceptance of, our products;
- protection for our patents and other intellectual property or trade secrets;
- our expectations regarding our relationships with investors, institutional funding partners, strategic partners and other parties we collaborate with;
- adverse side effects or inadequate therapeutic efficacy of our products that could slow or prevent product development or commercialization;
- dependence on third party suppliers;
- fluctuations in general economic and business conditions in the markets in which we operate; including those fluctuations caused by COVID-19;
- our ability to raise capital when needed;
- relevant government policies and regulations relating to our industry; and
- the outcome of any pending or threatened litigation.
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 for our fiscal year ended
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.
|
Consolidated Balance Sheets |
||||||||
|
|
|
|
|
|
|
|
||
|
|
|
|
|
|
||||
|
|
|
2021 |
|
2020 |
||||
|
Assets |
|
|
|
|
|
|
||
|
Current Assets: |
|
|
|
|
|
|
||
|
Cash and cash equivalents |
|
$ |
25,353,900 |
|
|
$ |
10,150,500 |
|
|
Accounts receivable |
|
|
16,200 |
|
|
|
— |
|
|
Prepaid expenses and other current assets |
|
|
1,699,400 |
|
|
|
588,800 |
|
|
Total current assets |
|
|
27,069,500 |
|
|
|
10,739,300 |
|
|
Property and equipment, net |
|
|
3,629,000 |
|
|
|
2,066,000 |
|
|
Other assets |
|
|
31,100 |
|
|
|
24,400 |
|
|
Total Assets |
|
$ |
30,729,600 |
|
|
$ |
12,829,700 |
|
|
|
|
|
|
|
|
|
||
|
Liabilities and Stockholders’ Equity: |
|
|
|
|
|
|
||
|
Current Liabilities: |
|
|
|
|
|
|
||
|
Accounts payable |
|
$ |
2,214,300 |
|
|
$ |
665,200 |
|
|
Accrued expenses and other current liabilities |
|
|
741,000 |
|
|
|
334,200 |
|
|
Interest payable |
|
|
— |
|
|
|
200 |
|
|
Loan payable |
|
|
— |
|
|
|
105,600 |
|
|
Note payable |
|
|
454,500 |
|
|
|
362,400 |
|
|
Total current liabilities |
|
|
3,409,800 |
|
|
|
1,467,600 |
|
|
|
|
|
|
|
|
|
||
|
Total Liabilities |
|
|
3,409,800 |
|
|
|
1,467,600 |
|
|
|
|
|
|
|
|
|
||
|
Commitments and contingencies (Note 9) |
|
|
|
|
|
|
||
|
Stockholders’ Equity: |
|
|
|
|
|
|
||
|
Common stock, |
|
|
9,300 |
|
|
|
1,200 |
|
|
Additional paid-in capital |
|
|
94,527,000 |
|
|
|
52,988,700 |
|
|
Accumulated deficit |
|
|
(67,216,500 |
) |
|
|
(41,627,800 |
) |
|
Total Stockholders’ Equity |
|
|
27,319,800 |
|
|
|
11,362,100 |
|
|
|
|
|
|
|
|
|
||
|
Total Liabilities and Stockholders’ Equity |
|
$ |
30,729,600 |
|
|
$ |
12,829,700 |
|
|
Consolidated Statements of Operations |
||||||||
|
|
|
|
||||||
|
|
|
Year Ended |
||||||
|
|
|
|
||||||
|
|
|
2021 |
|
2020 |
||||
|
Operating expenses: |
|
|
|
|
|
|
||
|
Research and development |
|
$ |
11,367,800 |
|
|
$ |
5,052,900 |
|
|
General and administrative |
|
|
13,937,900 |
|
|
|
14,144,000 |
|
|
Impairment expense |
|
|
430,000 |
|
|
|
— |
|
|
Total operating expenses |
|
|
25,735,700 |
|
|
|
19,196,900 |
|
|
Loss from operations |
|
|
(25,735,700 |
) |
|
|
(19,196,900 |
) |
|
Other income (expense) |
|
|
|
|
|
|
||
|
Gain on loan extinguishment |
|
|
105,800 |
|
|
|
— |
|
|
Other income |
|
|
53,400 |
|
|
|
— |
|
|
Interest expense |
|
|
(12,200 |
) |
|
|
(3,300 |
) |
|
Total other income (expense) |
|
|
147,000 |
|
|
|
(3,300 |
) |
|
Net loss |
|
$ |
(25,588,700 |
) |
|
$ |
(19,200,200 |
) |
|
Net loss per share, basic and diluted |
|
$ |
(2.26 |
) |
|
$ |
(4.42 |
) |
|
Weighted average common shares outstanding, basic and diluted |
|
|
11,417,083 |
|
|
|
4,505,867 |
|
|
Consolidated Statements of Cash Flows |
||||||||
|
|
|
|
||||||
|
|
|
Year Ended |
||||||
|
|
|
|
||||||
|
|
|
2021 |
|
2020 |
||||
|
Cash flows from operating activities: |
|
|
|
|
|
|
||
|
Net loss |
|
$ |
(25,588,700 |
) |
|
$ |
(19,200,200 |
) |
|
Adjustments to reconcile net loss to net cash used for operating activities: |
|
|
|
|
|
|
||
|
Depreciation |
|
|
469,800 |
|
|
|
200,000 |
|
|
Stock compensation expense |
|
|
3,762,900 |
|
|
|
13,245,700 |
|
|
Gain on loan extinguishment |
|
|
(105,800 |
) |
|
|
— |
|
|
Impairment expense |
|
|
430,000 |
|
|
|
— |
|
|
Non-cash interest |
|
|
— |
|
|
|
200 |
|
|
Inventory obsolescence impairment |
|
|
— |
|
|
|
22,200 |
|
|
Changes in operating assets and liabilities, net of effects from acquisition: |
|
|
|
|
|
|
||
|
Accounts receivable |
|
|
9,800 |
|
|
|
— |
|
|
Prepaid expenses and other current assets |
|
|
(1,117,400 |
) |
|
|
(499,700 |
) |
|
Accounts payable |
|
|
1,411,100 |
|
|
|
(7,700 |
) |
|
Accrued expenses and other current liabilities |
|
|
406,800 |
|
|
|
112,900 |
|
|
Net cash used for operating activities |
|
|
(20,321,500 |
) |
|
|
(6,126,600 |
) |
|
Cash flows from investing activities: |
|
|
|
|
|
|
||
|
Purchases of property and equipment, net of effects from acquisition |
|
|
(1,894,800 |
) |
|
|
(1,457,600 |
) |
|
Cash received from acquisition |
|
|
84,000 |
|
|
|
— |
|
|
Net cash used for investing activities |
|
|
(1,810,800 |
) |
|
|
(1,457,600 |
) |
|
Cash flows from financing activities: |
|
|
|
|
|
|
||
|
Proceeds from issuance of common stock |
|
|
40,000,000 |
|
|
|
15,000,000 |
|
|
Issuance cost |
|
|
(2,881,900 |
) |
|
|
(2,667,300 |
) |
|
Borrowings from note payable |
|
|
665,900 |
|
|
|
540,500 |
|
|
Repayments of note payable |
|
|
(573,700 |
) |
|
|
(178,100 |
) |
|
Exercise of stock options |
|
|
125,400 |
|
|
|
— |
|
|
Proceeds from warrant exercise |
|
|
— |
|
|
|
4,900 |
|
|
Proceeds from loan payable |
|
|
— |
|
|
|
115,600 |
|
|
Loan repayments |
|
|
— |
|
|
|
(10,000 |
) |
|
Proceeds from Series B Preferred Stock issuance |
|
|
— |
|
|
|
3,000,000 |
|
|
Net cash provided by financing activities |
|
|
37,335,700 |
|
|
|
15,805,600 |
|
|
Net change in cash and cash equivalents |
|
|
15,203,400 |
|
|
|
8,221,400 |
|
|
Cash and cash equivalents: |
|
|
|
|
|
|
||
|
Beginning of year |
|
|
10,150,500 |
|
|
|
1,929,100 |
|
|
End of period |
|
$ |
25,353,900 |
|
|
$ |
10,150,500 |
|
|
|
|
|
|
|
|
|
||
|
Supplemental disclosures of non-cash investing and financing activities: |
|
|
|
|
|
|
||
|
Accruals for property and equipment |
|
$ |
138,000 |
|
|
$ |
220,500 |
|
|
Cash paid for interest on note payable |
|
$ |
12,200 |
|
|
$ |
3,100 |
|
|
Common stock issuance for acquisition |
|
$ |
400,000 |
|
|
$ |
— |
|
|
Restricted stock units granted for acquisition |
|
$ |
140,000 |
|
|
$ |
— |
|
|
Acquisitions net of cash acquired |
|
$ |
456,000 |
|
|
$ |
— |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20220408005450/en/
Global Head, Corporate Communications
ldyson@kiromic.com
M: 281-468-7683
Source: