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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 9, 2023

KIROMIC BIOPHARMA, INC.

(Exact name of registrant as specified in its charter)

Delaware

    

001-39619

    

46-4762913

(State or other jurisdiction
of incorporation)

(Commission
File Number)

(IRS Employer
Identification No.)

7707 Fannin, Suite 140

Houston, TX, 77054

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code (832968-4888

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class

    

Trading Symbol(s)

    

Name of Each Exchange on Which Registered

Common Stock, $0.001 par value

KRBP

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Item 7.01            Regulation FD Disclosure

Kiromic BioPharma, Inc. (the "Company") intends to conduct meetings with third parties in which its corporate slide presentation will be presented. A copy of the presentation materials is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information in this Item 7.01 and the document attached as Exhibit 99.1 is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the "Exchange Act"), nor otherwise subject to the liabilities of that section, nor incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 8.01            Other Events

On November 9, 2023, the Company issued a press release announcing the start of the patient recruitment in the Deltacel Phase 1 Clinical Trial at Beverly Hills Cancer Center. A copy of the press release is furnished as Exhibit 99.2 to this Form 8-K.

Item 9.01.           Financial Statements and Exhibits

(d) Exhibits.

99.1

Corporate Presentation

99.2

Press release dated November 9, 2023

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Kiromic BioPharma, Inc.

Date: November 9, 2023

By: 

/s/ Pietro Bersani

Pietro Bersani

Chief Executive Officer

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Exhibit 99.1

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PAGE | 1 Revolutionizing CAR T-Cell Therapy BioPharma OTC PINK: KRBP Kiromic.com NOVEMBER 2023

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PAGE | Forward Looking Statements 2 This presentation 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 current and anticipated IND applications including statements regarding the scope of and timing for submission of an IND application; the Deltacel™ product platform; the sponsored research agreement and the data that will be generated as a result of such collaboration; the timing for submitting and activating Kiromic’s IND applications; the benefits of utilizing non-genetically engineered Gamma Delta T cells as our first in-human study; Kiromic’s ability to achieve its objectives; 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, 2022, 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.

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PAGE | 3 The Kiromic Difference Allogeneic, Off-the-shelf, T-Cell Therapy from Healthy Donors, Versus Frail Cancer Patients Solid Malignancie s (~90% of all cancers) Diamond AITM Neural Network Gamma Delta T-Cell (GDT) Platform Kiromic BioPharma is the only cell therapy company combining AI-driven genetically edited Gamma Delta T-cells (GDT) with proprietary targeting technology to address solid malignancies. In-House cGMP Manufacturing Solid Malignancies (~90% of all cancers)

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PAGE | 4 Contents Gamma Delta T-cell (GDT) Therapy: Mechanism of Action (MOA), Product Pipeline, cGMP Manufacturing Current Status and Path Forward The Kiromic Difference Diamond AITM (Artificial Intelligence)

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PAGE | Strategic Competitive Landscape 5 8 Known Companies (including Kiromic) in the Gamma Delta T Cell Therapy space. No Known Competitors with AI-driven Technology Combined with a Gamma Delta CAR-T Delivery Platform. AI-DRIVEN CAR-GDT

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PAGE | 6 1 Global CAR T-Cell Therapy Market, By Product Type, By Tumor Type, By Indication, By Treatment Type, By Targeted Antigen, By End User, By Region, Competition, Forecast and Opportunities, 2017-2027 (ReportLinker) 2 American Cancer Society, Cancer Facts & Figures, 2022..https://www.cancer.org/research/cancer-facts-statistics html Global CAR T-Cell Therapy Market by 20271 (USD) $33+ Billion Solid Malignancy Market Opportunity 90% of Cancers Are Solid Malignancies2

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PAGE | Competitive Difference 7 Allogeneic Gamma Delta Based T-Cell Therapies Superior specificity for multiple solid tumors Superior Efficacy from γδT cells Vertical Integration Lower Costs/ Greater Access2 Potential broad treatment for solid malignancies that express Kiromic developed biomarkers such as Iso-mesothelin. Solid tumors represent approx. 90% of new cancer diagnoses but finding specific targets to treat them has been challenging. Kiromic tackles the issue by identifying new cancer specific targets. Strong efficacy in pre-Clinical animal models. In solid tumors, the benefit of infiltrating conventional T cells may vary. In contrast, GDT cells are the infiltrating immune cells most likely to be associated with positive outcomes, as shown in an analysis of 18,000 tumors from 39 indications1 In-house cGMP manufacturing In-house QC/EM lab In-house product and process development (R&D and MSAT) 1.Outpatient treatment means reduced hospitalization and other treatment related costs. 2. Lower projected cost increases patient and health care professional access to these therapies, and potentially provides important quality-of-life benefits for patients as well. 1. Gentles AJ, Newman AM, Liu CL, et al. The prognostic landscape of genes and infiltrating immune cells across human cancers. Nat Med. 2015 Aug;21(8):938-945. 2. Maziarz RT. CAR T-cell therapy total cost can exceed $1.5M per treatment. Cell Therapy Next; May 29, 2019.

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PAGE | 8 Contents Gamma Delta T-cell (GDT) Therapy: Mechanism of Action (MOA), Product Pipeline, cGMP Manufacturing Current Status and Path Forward The Kiromic Difference Diamond AITM (Artificial Intelligence)

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PAGE | Artificial Intelligence and Bioinformatic Analytic 9 Discovery & Development Platform Algorithms and Large-Scale Genomics Analysis for Target Prediction Discovery Development Manufacturing Clinical Trials A.I. integrated with each stage of the Kiromic therapy production lifecycle Discovering New Multi-tumor Targets Identifying Optimal Donors and Patients to Maximize the Therapy Success

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PAGE | 10 Protein Structures, Gene Models, Gene Metadata Large Cancer Genomics Studies Diamond AITM Data Mining Tools • Cancer / Normal Differences • Cell Surface Proteins • Unique Targetable Peptides • Optimal Donor and Patient Selection Target Donor & Patient Selection Target Validation (Algorithm and wet lab Validation) Therapy Candidates Diamond AI prediction and validation platform reduce development costs by seeking to eliminate targets, donors, and patients that will ultimately fail laboratory analysis. Laboratory studies are then performed to confirm the validity of the AI selections. Diamond AI drives discovery by sifting through billions of data points to identify cancer specific immunotherapy targets, donors with the best GDT cell yields, and patients who will most likely benefit from our therapies. Clinical Trials (Phase I) The Kiromic Difference - Diamond AITM Target Discovery Platform Diamond AITM target discovery platform powers innovation and significantly reduces development time and cost. 1 2 3 Large Normal Tissue Genomics Studies * In Development Diamond Clinical AI models can continually improve the AI model Diamond Donor AI uses demographics, to maximize efficacy. cytometry, and sequence data to identify the best GDT cell donors – reducing manufacturing cost and potentially improving potency. Diamond data mining can guide selecting patients likely to benefit from Kiromic’s therapies. * *

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PAGE | 11 Contents Gamma Delta T-cell (GDT) Therapy: Mechanism of Action (MOA), Product Pipeline, cGMP Manufacturing Current Status and Path Forward The Kiromic Difference Diamond AI™ (Artificial Intelligence)

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PAGE | Kiromic GDT Cell Therapy Pipeline 12 Multiple Indications Unmodified, off-the-shelf product candidate targeting stress ligands on cancer cells Initial indication: NSCLC in combination with targeted, low-dose radiation Unmodified, off-the-shelf product candidate targeting stress ligands on cancer cells Initial indication: NSCLC in combination with targeted, low-dose radiation DeltacelTM Engineered off-the-shelf product candidate targeting PDL-1+ tumors ProcelTM Engineered off-the-shelf product candidate targeting a tumor-specific variant of Mesothelin in Ovarian Cancer, Mesothelioma, and Pancreatic Cancer Engineered off-the-shelf product candidate targeting a tumor-specific variant of Mesothelin in Ovarian Cancer, Mesothelioma, and Pancreatic Cancer IsocelTM

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PAGE | 13 Gamma Delta T-Cells (GDT): Guardians of the Immune System Off-the-Shelf Cryopreserved Allogeneic Healthy Donors Innate Rapid Acting Potent and Safe Commercially Viable GDT: 1-5% of circulating T-cells

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PAGE | 14 Deltacel: Non-Viral Gamma Delta T-Cell Development Bridge between the Innate and Adaptive Immune Response Kiromic Proprietary In-house GDT Cell Isolation and Expansion Rapid Response to Attack Cancer Cells Decreased Toxicity Risk Profile Virus Free Expansion and Production GDT: 1-5% of circulating T-cells

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PAGE | GDT Cell Therapy Mechanism of Action: 15 Targeting Unique Identifiers on Tumor Tissues TARGET Deltacel: Stress Ligand GDT Cell Deltacel: GDT Cell Receptor Upon binding, the GDT cells are instructed to kill tumors expressing the respective target Cancer cell

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PAGE | 16 KB-GDT-01 T-Cell Therapy (Deltacel) Strong Efficacy DeltacelTM effectively controls established A549 NSCLC tumors in immunocompromised mice when combined with a low-dose radiation DeltacelTM does not cause any macroscopic or microscopic toxicity, even when given at over 8x the maximum dose that will be tested in the clinical trial KB-GDT-01 T-Cell Therapy (Deltacel) Strong Safety Female, control Male, control Female, Deltacel Male, Deltacel Body weight  There were no treatment-associated impacts on body weights, food consumption, or cage-side/clinical observations. Macroscopic evaluations at necropsy did not identify any evidence of test article-related toxicity. Microscopic histopathological evaluations showed no evidence of Deltacel-related toxicity  Clinical pathology evaluations determined that all fluctuations among individual and mean values of tested analytes were considered sporadic, and not related to the administration of Deltacel.  Plasma cytokine analysis showed that Deltacel administration did not result in the overproduction of inflammatory cytokines which may pose a safety concern. 0 10 20 30 80 85 90 95 100 Time (days) Probability of Survival Vehicle Radiation Deltacel Combination Vehicle Standard Therapy Deltacel (KB-GDT-01) Combo

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PAGE | 17 GDT CAR T-Cell Therapy (IsocelTM)* Strong Efficacy IsocelTM eradicates established NCI-H226 pleural epithelioid mesothelioma and prevents tumor growth in a model of recurrence. IsocelTM does not lead to cytokine level increases modeled to cause severe CRS or CRS, with circulating cell numbers regulated by objective response. GDT CAR T-Cell Therapy (IsocelTM)* Strong Safety Tumor eradication *Preclinical models: nude mice with subcutaneous NCI-H226 cells injections

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PAGE | 18 GDT chPD1 T-Cell Therapy (ProcelTM)* Strong Efficacy ProcelTM eradicates established NCI-H226 pleural epithelioid mesothelioma and extends survival. ProcelTM does not lead to cytokine level increases modeled to cause severe CRS or CRS, with circulating cell numbers regulated by objective response. GDT chPD1 T-Cell Therapy (ProcelTM)* Strong Safety Tumor eradication *Preclinical models: nude mice with subcutaneous NCI-H226 cells injections

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PAGE | Pipeline 19 Clinical Trial Candidate Target Pre-Clinical Phase I ALEXIS - PRO-1 ProcelTM Allogeneic, off-the-shelf, GDT CAR-T therapy PD-L1 ALEXIS - ISO-1 IsocelTM Allogeneic, off-the-shelf, GDT CAR-T therapy Deltacel-01 DeltacelTM in combination with low-dose radiation Allogeneic, Non-Viral, Non-engineered off-the-shelf GDT therapy Recruitment started November 2023 Universal Non-Engineered New IND ProcelTM in combination with low-dose radiation Allogeneic, off-the-shelf, GDT CAR-T therapy Expected Beginning of Activation Process for Clinical Trial H1 2025* PD-L1 New IND IsocelTM in combination with low-dose radiation Allogeneic, off-the-shelf, GDT CAR-T therapy Mesothelin Isoform KRBP proprietary target * Subject to obtaining sufficient financing to support the progression of the development of those additional clinical trial candidates. New IND New IND Expected Beginning of Activation Process for Clinical Trial H1 2025* Expected Beginning of Activation Process for Clinical Trial H1 2025* Expected Beginning of Activation Process for Clinical Trial H1 2025* Mesothelin Isoform KRBP proprietary target

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PAGE | 20 In-House Manufacturing Creates De-Risked Value Dedicated Product Development Suite 34,000 sq ft Facility Operations 12,000 sq ft R&D Laboratory & Manufacturing Space Dedicated cGLP Microbiology and QC Lab Clinical-Grade, cGMP-Compliant Cell Therapy Manufacturing Space

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PAGE | 21 Contents Gamma Delta T-cell (GDT) Therapy: Mechanism of Action (MOA), Product Pipeline, cGMP Manufacturing Current Status and Path Forward The Kiromic Difference Diamond AI™ (Artificial Intelligence)

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PAGE | 22 Recent and Upcoming Milestones* *The milestones and timing of completion are based upon the company’s current expectations in consultation with its partners and vendors. ** Subject to obtaining sufficient financing to support the progression of the development of those additional clinical trial candidates. 1 IND Authorization for Deltacel-01 3 Early Tolerability Results First Patient* Deltacel-01 Patient Recruitment Begins 2 5 Completion of Dose Escalation, Safety and Efficacy Data 4 Early Efficacy Results First Patient* Submission Isocel and Procel INDs** 6

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PAGE | 23 Brian Hungerford CPA,CGMA Leadership Team Scott Dahlbeck MD, PharmD COSO Texas Tech Univ Health Science Center University of TX Health Science Center Houston College of Pharmacy CEO Pietro Bersani CPA, CGMA CSO/INTERIM COO Leonardo Mirandola Ph.D. CFO

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PAGE | 24 Board of Directors Michael Nagel Chairperson Pam Misajon Director Pietro Bersani CPA, CGMA Independent Director Independent Director Michael Catlin

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PAGE | Summary Balance Sheet & Cap Table 25 Balance Sheet Data (As of June 30, 2023) As Reported Cash and Cash Equivalents $2,707,136 Working Capital ($12,851,255) Total Assets $14,005,661 Total Stockholders’ Deficit ($5,159,281) Cap Table (As of June 30, 2023) Common Stock Equivalents Common Stock 1,176,290 Restricted Stock Units ($258.88 Weighted average grant date fair value) 632 Options ($287.58 Weighted average exercise price) - Warrants - Convertible Preferred Share Shares ($8MM principal & $6.50 share conversion) 1,230,769 Convertible Notes ($6MM principal a& $6.50 share conversion) 1,292,308 Fully Diluted Common Shares 3,699,999

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PAGE | 26 1American Cancer Society, Cancer Facts & Figures, 2022..https://www.cancer.org/research/cancer-facts-statistics.html. 1 2 3 Value Proposition Summary Gamma Delta CAR-T Cell Therapy Platform In-House cGMP Manufacturing Diamond AITM Neural Network 4 5 Solid Malignancies (~90% of all cancers1) Allogeneic, Off-the-shelf Cellular Therapy Cells from healthy donors, not ill cancer patients, for maximum efficacy

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PAGE | 27 Revolutionizing CAR T-Cell Therapy BioPharma OTC PINK: KRBP Kiromic.com NOVEMBER 2023

Exhibit 99.2

Kiromic BioPharma Announces Deltacel Phase 1 Clinical Trial Enters Patient Recruitment Phase at Beverly Hills Cancer Center

Company is Activating Additional Clinical Trial Sites Across the U.S.

HOUSTON (November 9, 2023) – Kiromic BioPharma, Inc. (OTC PINK: 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 therapies with a focus on immuno-oncology, announces the Deltacel Phase 1 Clinical Trial is now recruiting patients at the Beverly Hills Cancer Center (BHCC). The study will evaluate Deltacel (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with metastatic non-small cell lung cancer (NSCLC).

The Company continues to engage additional clinical trial sites across the U.S, and will provide updates as additional sites are activated, and as patient recruitment starts at those locations.

The Phase 1 trial, titled “Safety Study for a Gamma Delta T Cell Product Used With Low Dose Radiotherapy in Patients With Stage 4 Metastatic NSCLC” (ID# NCT06069570), expects to enroll up to 48 patients.  In this open-label, two-part trial, patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel along with four courses of low-dose, localized radiation, over a 10-day period. The primary objective of the study is to evaluate the safety of Deltacel in combination with low-dose radiation; the secondary outcome measures are objective response, progression-free survival, overall survival, time to progression, time to treatment response, and disease control rates.

“We are delighted to announce the start of patient recruitment in our first clinical trial, and we look forward to working with BHCC and the other prestigious trial sites we will be activating across the U.S.  Importantly, we are on target to dose our first patient, and we expect to have early tolerability and safety data from this patient available by the end of 2023,” stated Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. “We plan to assess preliminary efficacy by end of January 2024, and complete the dose-escalation portion of the study by the second half of 2024, at which point we expect to have sufficient evidence supporting the tolerability and the efficacy of Deltacel™. These are crucial steps forward as we advance our goal to bring a transformative new treatment to patients with advanced NSCLC.”

About Deltacel (KB-GDT-01)

Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of non–small cell lung cancer. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is Kiromic BioPharma’s lead candidate in its GDT platform.  Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial focus on NSCLC, the most prevalent type of lung cancer and representing about 80% to 85% of lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.

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About Beverly Hills Cancer Center

As a private, academic, community-based cancer center, Beverly Hills Cancer Center not only provides state-of-the-art cancer treatment modalities all under one roof, but also leading clinical trials and research for cancer that are offered at very few centers in the world, attracting patients globally and saving lives. By providing access to groundbreaking clinical trials, the Beverly Hills Cancer Center offers patients the opportunity to participate in the most advanced cancer treatments in development in the world.  Beverly Hills Cancer Center is comprised of an internationally recognized multidisciplinary medical team consisting of medical oncologists, radiation oncologists, radiologists, hematologists, and internists who provide exceptional patient care and support services including a robust and highly efficient team of clinical research professionals. For more information, visit: www.bhcancercenter.com.

About Kiromic BioPharma

Kiromic BioPharma, Inc. is a clinical-stage, fully integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence (AI) 2.0 target discovery engine to develop and commercialize cell therapies focusing on immuno-oncology. Kiromic is developing a multi-indication allogeneic cell therapy platform that exploits the natural potency of Gamma Delta T-cells to target solid tumors. Kiromic’s DIAMOND® AI is where data science meets target identification to dramatically compress the years and hundreds of millions of 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. 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 ability to achieve its objectives and Kiromic’s financing strategy and availability of funds. 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, 2022, and as detailed from time to time in our other 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.

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Contacts:

 

Kiromic BioPharma

Linda Phelan Dyson, MPH

Global Head, Corporate Communications

ldyson@kiromic.com 
281-468-7683

 

LHA Investor Relations

Tirth T. Patel

tpatel@lhai.com

212-201-6614

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