Kiromic BioPharma Provides Business Update and Reports Third Quarter 2021 Financial Results
Quarter Updates Include Company’s Progress in the Following Areas:
Expansion of DIAMOND® AI Platform to More than 1.
Completion of InSilico Solutions, LLC Acquisition
Closing of Public Offering
Addition of Key Personnel Across Bioinformatics, Clinical Translational, Manufacturing, and Operations
“We believe that we made meaningful progress during the third quarter of 2021 with our corporate developments and with our chemical manufacturing and control manufacturing processes. We believe these developments will allow us to effectively address the FDA clinical hold comments, and will ensure that we are well positioned to advance our oncology cell therapy trial candidates. We were also able to recently complete an internal review associated with certain complaints that the Company received through its complaint hotline. The internal review was conducted by a Special Committee of our Board of Directors. The Company was precluded from filing its Form 10-Q in
Recent Business Highlights:
-
Surpassed 1.5 billion Data Points Powering Kiromic’s DIAMOND®AI Platform for Drug Discovery and Development: The Company added approximately 300 million data points in 2021, representing a 25% increase from 2020. Kiromic’s growing machine learning platform is designed to identify new therapeutic opportunities, prioritizing T and B cell targets, and accelerate development. The increase was primarily driven by
Clinical Proteomic Tumor Analysis Consortium (“CPTAC”) and Blood Donor Artificial Intelligence analysis. CPTAC is a data portal serving as a centralized repository for the public dissemination of proteomic sequence datasets collected by CPTAC along with corresponding genomic sequence datasets. The National Cancer Institute’s CPTAC is a national effort to accelerate the understanding of the molecular basis of cancer through the application of large-scale proteome and genome analysis, or proteogenomics.
-
Completion of InSilico Solutions, LLC Acquisition: On
July 26, 2021 , we announced the completion of theInsilico Solutions, LLC acquisition. InSilico Solutions is a world-class bioinformatics and artificial intelligence (AI) innovator with long-standing collaborative relationships with its clients atUniversity of Texas MD Anderson Cancer Center ,Johns Hopkins School of Medicine , and theNational Cancer Institute . With this acquisition, Kiromic expanded its team with experts in bioinformatics and AI to accelerate its AI-driven efforts identifying the optimal biomarkers for advanced immuno-oncology therapies like CAR-T cell therapy.
-
Closing of Public Offering: On
July 2, 2021 , we received net proceeds of$37,118,100 from a public offering, after deducting underwriting discounts and commissions of$2,494,900 and other offering expenses of$387,000 incurred. The Company issued and sold 8,000,000 shares of common stock in the public offering at a price of$5.00 per share. In connection with the public offering, 400,000 representative warrants were issued with a price of$6.25 per share
-
Key Hires inBioinformatics , Manufacturing, Clinical Translational Medicine and Operations: The Company added 24 new hires to positions acrossBioinformatics , Manufacturing, Clinical Translational Medicine, and Operations. This represents a total of 37 employees, which is an increase from 13 as ofDecember 31, 2020 .
Q3 2021 Financial Highlights
Cash Position: Cash and cash equivalents were
R&D Expenses: Our research and development expenses increased by
G&A Expenses: Our general and administrative expenses increased by
Net Loss: Our net loss decreased to
About
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 big data science meets target identification to dramatically compress the man-years and billions of drug development dollars required to develop a live drug. The Company maintains offices in
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
- 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; 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 Registration Statement on Form S-1 (Registration No. 333-257427) , originally filed with the
The forward-looking statements made in this report relate only to events or information as of the date on which the statements are made in this report. 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.
|
|
||||||||
|
|
||||||||
|
|
|
|
|
|
||||
|
|
|
2021 |
|
2020 |
||||
|
Assets |
|
|
|
|
|
|
||
|
Current Assets: |
|
|
|
|
|
|
||
|
Cash and cash equivalents |
|
$ |
35,161,800 |
|
|
$ |
10,150,500 |
|
|
Accounts receivable |
|
|
5,800 |
|
|
|
— |
|
|
Prepaid expenses and other current assets |
|
|
750,500 |
|
|
|
588,800 |
|
|
Total current assets |
|
|
35,918,100 |
|
|
|
10,739,300 |
|
|
Property and equipment, net |
|
|
2,578,800 |
|
|
|
2,066,000 |
|
|
Other assets |
|
|
31,200 |
|
|
|
24,400 |
|
|
Intangible assets, net |
|
|
41,800 |
|
|
|
— |
|
|
|
|
|
386,000 |
|
|
|
— |
|
|
Total Assets |
|
$ |
38,955,900 |
|
|
$ |
12,829,700 |
|
|
|
|
|
|
|
|
|
||
|
Liabilities and Stockholders’ Equity: |
|
|
|
|
|
|
||
|
Current Liabilities: |
|
|
|
|
|
|
||
|
Accounts payable |
|
$ |
927,700 |
|
|
$ |
665,200 |
|
|
Accrued expenses and other current liabilities |
|
|
517,100 |
|
|
|
334,200 |
|
|
Interest payable |
|
|
— |
|
|
|
200 |
|
|
Loan payable |
|
|
— |
|
|
|
105,600 |
|
|
Note payable |
|
|
— |
|
|
|
362,400 |
|
|
Total current liabilities |
|
|
1,444,800 |
|
|
|
1,467,600 |
|
|
|
|
|
|
|
|
|
||
|
Total Liabilities |
|
|
1,444,800 |
|
|
|
1,467,600 |
|
|
|
|
|
|
|
|
|
||
|
Commitments and contingencies (Note 8) |
|
|
|
|
|
|
||
|
Stockholders’ Equity: |
|
|
|
|
|
|
||
|
Common stock, |
|
|
9,300 |
|
|
|
1,200 |
|
|
Additional paid-in capital |
|
|
94,083,200 |
|
|
|
52,988,700 |
|
|
Accumulated deficit |
|
|
(56,581,400 |
) |
|
|
(41,627,800 |
) |
|
Total Stockholders’ Equity |
|
|
37,511,100 |
|
|
|
11,362,100 |
|
|
|
|
|
|
|
|
|
||
|
Total Liabilities and Stockholders’ Equity |
|
$ |
38,955,900 |
|
|
$ |
12,829,700 |
|
|
|
||||||||||||||||
|
|
||||||||||||||||
|
|
|
Three Months Ended |
|
Nine Months Ended |
||||||||||||
|
|
|
|
|
|
||||||||||||
|
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
||||||||
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Research and development |
|
$ |
3,486,700 |
|
|
$ |
1,225,700 |
|
|
$ |
8,030,400 |
|
|
$ |
3,526,100 |
|
|
General and administrative |
|
|
2,655,600 |
|
|
|
1,190,000 |
|
|
|
7,040,700 |
|
|
|
12,109,200 |
|
|
Total operating expenses |
|
|
6,142,300 |
|
|
|
2,415,700 |
|
|
|
15,071,100 |
|
|
|
15,635,300 |
|
|
Loss from operations |
|
|
(6,142,300 |
) |
|
|
(2,415,700 |
) |
|
|
(15,071,100 |
) |
|
|
(15,635,300 |
) |
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Gain on loan extinguishment |
|
|
— |
|
|
|
— |
|
|
|
105,800 |
|
|
|
— |
|
|
Other income |
|
|
18,000 |
|
|
|
|
|
|
18,000 |
|
|
|
|
||
|
Interest expense |
|
|
(500 |
) |
|
|
— |
|
|
|
(6,300 |
) |
|
|
— |
|
|
Total other income (expense) |
|
|
17,500 |
|
|
|
— |
|
|
|
117,500 |
|
|
|
— |
|
|
Net loss |
|
$ |
(6,124,800 |
) |
|
$ |
(2,415,700 |
) |
|
$ |
(14,953,600 |
) |
|
$ |
(15,635,300 |
) |
|
Net loss per share, basic and diluted |
|
$ |
(0.40 |
) |
|
$ |
(0.48 |
) |
|
$ |
(1.50 |
) |
|
$ |
(4.39 |
) |
|
Weighted average common shares outstanding, basic and diluted |
|
|
15,366,075 |
|
|
|
4,989,269 |
|
|
|
10,048,170 |
|
|
|
3,719,132 |
|
|
|
||||||||
|
|
||||||||
|
|
|
Nine Months Ended |
||||||
|
|
|
|
||||||
|
|
|
2021 |
|
2020 |
||||
|
Cash flows from operating activities: |
|
|
|
|
|
|
||
|
Net loss |
|
$ |
(14,953,600 |
) |
|
$ |
(15,635,300 |
) |
|
Adjustments to reconcile net loss to net cash used for operating activities: |
|
|
|
|
|
|
||
|
Depreciation |
|
|
331,200 |
|
|
|
118,900 |
|
|
Amortization |
|
|
2,200 |
|
|
|
|
|
|
Stock compensation expense |
|
|
3,319,100 |
|
|
|
11,580,000 |
|
|
Gain on loan extinguishment |
|
|
(105,800 |
) |
|
|
— |
|
|
Changes in operating assets and liabilities, net of effects from acquisitions: |
|
|
|
|
|
|
||
|
Accounts receivable |
|
|
20,200 |
|
|
|
— |
|
|
Prepaid expenses and other current assets |
|
|
(168,500 |
) |
|
|
(149,800 |
) |
|
Accounts payable |
|
|
216,000 |
|
|
|
398,300 |
|
|
Accrued expenses and other current liabilities |
|
|
182,900 |
|
|
|
130,700 |
|
|
Net cash used for operating activities |
|
|
(11,156,300 |
) |
|
|
(3,557,200 |
) |
|
Cash flows from investing activities: |
|
|
|
|
|
|
||
|
Purchases of property and equipment, net of effects from acquisitions |
|
|
(797,500 |
) |
|
|
(1,013,100 |
) |
|
Cash received from acquisition |
|
|
84,000 |
|
|
|
— |
|
|
Net cash used for investing activities |
|
|
(713,500 |
) |
|
|
(1,013,100 |
) |
|
Cash flows from financing activities: |
|
|
|
|
|
|
||
|
Proceeds from issuance of common stock |
|
|
40,000,000 |
|
|
|
— |
|
|
Issuance cost |
|
|
(2,881,900 |
) |
|
|
— |
|
|
Exercise of stock options |
|
|
125,400 |
|
|
|
— |
|
|
Proceeds from warrant exercise |
|
|
— |
|
|
|
4,900 |
|
|
Proceeds from loan payable |
|
|
— |
|
|
|
115,600 |
|
|
Loan repayments |
|
|
(362,400 |
) |
|
|
(10,000 |
) |
|
Proceeds from Series B Preferred Stock issuance |
|
|
— |
|
|
|
3,000,000 |
|
|
Net cash provided by financing activities |
|
|
36,881,100 |
|
|
|
3,110,500 |
|
|
Net change in cash and cash equivalents |
|
|
25,011,300 |
|
|
|
(1,459,800 |
) |
|
Cash and cash equivalents: |
|
|
|
|
|
|
||
|
Beginning of year |
|
|
10,150,500 |
|
|
|
1,929,100 |
|
|
End of period |
|
$ |
35,161,800 |
|
|
$ |
469,300 |
|
|
|
|
|
|
|
|
|
||
|
Supplemental disclosures of non-cash investing and financing activities: |
|
|
|
|
|
|
||
|
Accruals for property and equipment |
|
$ |
46,500 |
|
|
$ |
130,200 |
|
|
Cash paid for interest on note payable |
|
$ |
6,300 |
|
|
$ |
— |
|
|
Common stock issuance for acquisition |
|
$ |
400,000 |
|
|
$ |
— |
|
|
Restricted stock units granted for acquisition |
|
$ |
140,000 |
|
|
$ |
— |
|
|
Acquisitions net of cash acquired |
|
$ |
456,000 |
|
|
$ |
— |
|
|
Accruals for deferred public offering costs |
|
$ |
— |
|
|
$ |
813,000 |
|
|
Warrants underlying Series B Preferred Stock issuance |
|
$ |
— |
|
|
$ |
2,668,300 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20220311005406/en/
Global Head, Corporate Communications
ldyson@kiromic.com
973-986-5973
Source: