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    Kiromic BioPharma Reports Fourth Quarter and Full-Year 2021 Financial Results and Recent Corporate Highlights

    4/8/22 4:07:00 PM ET
    $KRBP
    Medicinal Chemicals and Botanical Products
    Health Care
    Get the next $KRBP alert in real time by email

    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

    Kiromic BioPharma, Inc. (NASDAQ:KRBP) ("Kiromic" or the "Company"), a clinical-stage fully integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence (AI) and big data mining platform to discover and develop cell and gene therapies with a therapeutic focus on immuno-oncology, today announces financial results for the fourth quarter and fiscal year ended December 31, 2021.

    "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 Pietro Bersani, Kiromic BioPharma's Interim Chief Executive Officer. "We have been intensely preparing for this milestone, ensuring we have the right team, the right capabilities, and the right processes in place to achieve this objective. Our team has been executing critical advancements - occurring simultaneously - across our research and development, clinical trial preparation, facility expansion, and manufacturing operations, among other functions. We look forward to more opportunities to communicate with our shareholders as we demonstrate the Company's overall progress."

    Fiscal Year Ended 2021 Financial Highlights:

    • Cash Position: Cash and cash equivalents were $25,353,900 as of December 31, 2021, compared to $10,150,500 as of December 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 ended December 31, 2021 from $5,052,900 for the year ended December 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 ended December 31, 2021 from $14,144,000 for the year ended December 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 ended December 31, 2021 compared to $19,200,200 during the year ended December 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.

    Key Hires in Research & Development, Clinical Translational Medicine and Clinical Trial Preparation:

    • 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 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 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 Houston, Texas. To learn more, visit www.kiromic.com and connect with us on Twitter and LinkedIn.

    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;
    • 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 December 31, 2021 filed with the SEC on April 8, 2022 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.

    KIROMIC BIOPHARMA, INC.

    Consolidated Balance Sheets

     

     

     

     

     

     

     

     

     

    December 31,

     

    December 31,

     

     

    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, $0.001 par value: 300,000,000 shares authorized as of December 31, 2021 and 2020; 15,488,516 shares and 7,332,999 shares issued and outstanding as of December 31, 2021 and 2020, respectively

     

     

    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

     

    KIROMIC BIOPHARMA, INC.

    Consolidated Statements of Operations

     

     

     

     

     

    Year Ended

     

     

    December 31,

     

     

    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

     

    KIROMIC BIOPHARMA, INC.

    Consolidated Statements of Cash Flows

     

     

     

     

     

    Year Ended

     

     

    December 31,

     

     

    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/

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    • SEC Form SC 13D filed by Kiromic BioPharma Inc.

      SC 13D - Kiromic Biopharma, Inc. (0001792581) (Subject)

      5/20/24 5:00:06 PM ET
      $KRBP
      Medicinal Chemicals and Botanical Products
      Health Care
    • SEC Form SC 13D/A filed by Kiromic BioPharma Inc. (Amendment)

      SC 13D/A - Kiromic Biopharma, Inc. (0001792581) (Subject)

      5/9/24 5:00:18 PM ET
      $KRBP
      Medicinal Chemicals and Botanical Products
      Health Care
    • Kiromic BioPharma Inc. filed SEC Form 8-K: Bankruptcy or Receivership, Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year

      8-K - Kiromic Biopharma, Inc. (0001792581) (Filer)

      3/21/25 9:05:01 AM ET
      $KRBP
      Medicinal Chemicals and Botanical Products
      Health Care
    • Kiromic BioPharma Inc. filed SEC Form 8-K: Other Events

      8-K - Kiromic Biopharma, Inc. (0001792581) (Filer)

      3/17/25 5:26:56 PM ET
      $KRBP
      Medicinal Chemicals and Botanical Products
      Health Care
    • Amendment: SEC Form S-1/A filed by Kiromic BioPharma Inc.

      S-1/A - Kiromic Biopharma, Inc. (0001792581) (Filer)

      2/19/25 4:57:39 PM ET
      $KRBP
      Medicinal Chemicals and Botanical Products
      Health Care
    • Chief Executive Officer Bersani Pietro bought $7,407 worth of shares (3,488 units at $2.12), increasing direct ownership by 3% to 142,333 units (SEC Form 4)

      4 - Kiromic Biopharma, Inc. (0001792581) (Issuer)

      8/26/24 6:44:11 PM ET
      $KRBP
      Medicinal Chemicals and Botanical Products
      Health Care
    • Chief Financial Officer Hungerford Brian bought $8,802 worth of shares (4,000 units at $2.20), increasing direct ownership by 7% to 64,933 units (SEC Form 4)

      4 - Kiromic Biopharma, Inc. (0001792581) (Issuer)

      8/21/24 4:29:54 PM ET
      $KRBP
      Medicinal Chemicals and Botanical Products
      Health Care
    • Chief Financial Officer Hungerford Brian bought $3,500 worth of shares (2,000 units at $1.75), increasing direct ownership by 3% to 60,933 units (SEC Form 4)

      4 - Kiromic Biopharma, Inc. (0001792581) (Issuer)

      8/14/24 5:03:04 PM ET
      $KRBP
      Medicinal Chemicals and Botanical Products
      Health Care
    • Kiromic BioPharma Appoints Leonardo Mirandola, Ph.D. as Chief Scientific Officer

      Kiromic BioPharma, Inc. (NASDAQ:KRBP) ("Kiromic" or the "Company"), a clinical-stage fully integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence and data mining platform to develop cell and gene therapies with a focus on immuno-oncology, announces the appointment of Leonardo Mirandola, Ph.D., as Chief Scientific Officer, effective immediately. Dr. Mirandola has served as the Company's Vice President of Research & Development and Clinical Translation since September 2021. His previous role was Head of Clinical Translation from 2020 to 2021, having joined the Company in 2016 as Executive Director of Research and Development (R&D). "We are delighted to name

      7/12/22 8:18:00 AM ET
      $KRBP
      Medicinal Chemicals and Botanical Products
      Health Care
    • Kiromic BioPharma Appoints Frank Tirelli and Dr. Karen Reeves to Company's Board of Directors

      – Frank Tirelli Will Serve as Chair of Kiromic's Audit Committee – – Dr. Reeves Brings Deep Biopharmaceutical, Regulatory, and Clinical Expertise to Board Role – Kiromic BioPharma, Inc. (NASDAQ:KRBP) ("Kiromic" or the "Company"), a clinical-stage fully integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence (AI) and big data mining platform to discover and develop cell and gene therapies with a therapeutic focus on immuno-oncology and other diseases, today announces the appointment of two outside directors to the Company's Board of Directors: Frank Tirelli and Karen Reeves, M.D. Frank Tirelli was appointed to the Company's Board effective on January 28,

      2/3/22 8:02:00 AM ET
      $KRBP
      Medicinal Chemicals and Botanical Products
      Health Care
    • Kiromic Announces Expansion of In-House Cell therapy cGMP Manufacturing Facility and the Appointment of Industry Veteran Ignacio Núñez as Chief Operating and Manufacturing Officer

      HOUSTON--(BUSINESS WIRE)--Kiromic BioPharma, Inc. (Nasdaq: KRBP) — Expansion of in-house cGMP manufacturing facility to provide support to the Company's clinical trials. Therapeutic doses expected to be ready for first in-human dosing in 3Q-2021. — Mr. Ignacio Núñez, a 20-year industry veteran in global operations and manufacturing, is joining the Kiromic team to take the company to the next level and to scale up cGMP manufacturing capabilities internally. Kiromic is an immuno-oncology company using Artificial Intelligence (AI) to identify critical markers in solid tumors to develop Allogeneic CAR-T cell therapy. Kiromic’s CAR-T technology addresses critical efficacy and safet

      6/7/21 8:07:00 AM ET
      $KRBP
      Medicinal Chemicals and Botanical Products
      Health Care