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): April 8, 2021
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 |
7707 Fannin, Suite 140
Houston, TX, 77054
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code (832) 968-4888
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) |
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[ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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[ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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[ ] | 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 [X]
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. [ ]
SMRH:4812-4287-8693.1 | -1- | |
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Item 1.01. Entry into a Material Definitive Agreement
On April 8, 2021, Kiromic BioPharma, Inc. (the “Company”) entered into a letter of intent (the “Letter of Intent”) with the University of Texas MD Anderson Cancer Center (“MD Anderson”) pursuant to which MD Anderson shall receive a research grant from the Company titled, “Validation of biomarker isomeso for pancreatic cancer,” which is aimed at discovering new cancer-specific antigen targets (the “Grant”). Pursuant to the Grant, Professor Robert S. Bresalier M.D., who works in the Department of Gastroenterology, Hepatology and Nutrition at the MD Anderson Center, will serve as principle investigator. The total costs to the Company to be paid in connection with the Grant shall be in the low to mid six digit figures. Pursuant to the Letter of Intent, the Grant shall commence on April 1, 2021 and end on March 31, 2022.
The foregoing summary does not purport to be complete and is qualified in its entirety by reference to the Letter of Intent, which is attached hereto as Exhibit 10.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibit
(d) Exhibits.
Exhibit Number |
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Description |
10.1# |
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# Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit were omitted by means of marking such portions with an asterisk because the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.
SMRH:4812-4287-8693.1 | -2- | |
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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. | |
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Date: April 13, 2021 | By: | /s/ Maurizio Chiriva Internati |
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| Maurizio Chiriva Internati Chief Executive Officer |
SMRH:4812-4287-8693.1 | -3- | |
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Exhibit 10.1
[*] Certain information in this document has been omitted from this exhibit because it is both (i) not materialand (ii) would be competitively harmful if publicly disclosed.
April 7, 2021
NOTICE OF AWARD
TO | From |
Office of Sponsored Programs University of Texas MD Anderson Cancer Center 1515 Holcombe Boulevard Houston, Texas 77030 (713) 792 3220 | Financial Department Kiromic BioPharma, Inc. Fannin South Professioral Building, Suite 140 Houston, Texas 77054 (832) 968 4888 |
("MD Anderson") | ("Kiromic") |
Title of Grant: Validation of biomarker isomeso for pancreatic cancer We are providing this letter of intent for a contract which is to be awarded to: Professor Robert S. Bresalier M.D.
Department of Gastroenterology, Hepatology and Nutrition (Principle Investigator), the
University of Texas MD Anderson Cancer Center for conduct of the above: research grant.
MD Anderson is a member institution of the University of Texas System, and as such, is a government agency of the State of Texas, which under the Constitution and the laws of the state of Texas possess certain rights and privileges, is subject to certain Imitations and restrictions, and only has such authority as is granted under the Constitution and laws of the State of Texas. Notwithstanding any provision hereof, nothing in this gran: agreement is intended to be, nor will it be construed to be, a waiver of the sovereign im11unity of the State of Texas or a prospective waiver or restriction of any of the rights, remedies, claims, and privileges of the State of Texas.
/s/ Tony Tontat
Tony Tontat – Chief Financial Officer of Kiromic BioPharma, Inc
4/8/2021
Date
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Dates of Grants
Start Date of Grant | April 1, 2021 |
End Date of Grant | March 31, 2022 |
Payment Schedule | Invoicing Schedule every first of the month. Kiromic will pay MD Anderson monthly for the grant work performed in the prior month within thirty (30) days of receipt of invoice. |
Payment Information
Payment Information By Check | [*] |
Payment Information By Electronic ACH | [*] |
Payment Information By Bank Wire Transfers | [*] |
[*]
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Progress Reporting Schedule
First reporting date | July 2021 |
Second reporting date | October 2021 |
Third reporting date | January 2022 |
Four, and Last reporting date | March 2022 |
Total Cost of Research Grant
Direct costs | $[*] |
Indirect costs (clinical trial) | $[*] |
Total Costs | $[*] |
Kiromic person to be invoiced | [*] 7707 Fannin Street, Suite 140, Houston, Texas 77054; [*] [*] |
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Scope of Work - OVERVIEW
| • | The most significant barrier to developing the next generation of patient-specific immunotherapy products is the discovery of new cancer-specific antigen targets. |
Finding new targets, particularly for solid tumors, is a challenge due to the fact that finding the exact protein that meets a number of critical variables in order to be safe and non-toxic is difficult due to the shared expression of most tumor-associated antigens with normal tissues and organs.
Mesothelin is a glycoprotein over-expressed by multiple solid tumors, suitable for targeted immunotherapies. MSLN has three isoforms; lsoform 1 and 2 are membrane isoform with only difference of presence of 8 amino acids in isoform 2; lsoform 3 is soluble form.
Study of the differential expression of mesothelin isoforms between normal and cancer cells has identified a tumor-specific variant carrying a unique sequence of amino acids which is not found in normal MSLN positive cells and can be targeted by monoclonal antibodies and CAR. MSLN isoform 2 (lsoMSLN) is a tumor-specific antigen which can be targeted to control MSLN isoform 2-expressing tumors.
Based on semi-quantitative PCR, flow cytometry and immunohistochemis!ry, this isoform appears to be expressed in pancreatic adenocarcinoma cells but normal pancreas.
Dr. Bresalier's research group has extensive experience in cancer prevention and biomarker development, cancer vaccine development and translational applications which span the spectrum from laboratory studies to randomized clinical trials, including extensive experience in collection of clinical specimens for biomarker development , biomarker validation, and translation from the lab to clinical application.
Last edited: 04/ 07/ 2021, Tony Tontat, CFO, COO - Ki rami e Bio | Page 5 |
Details of Work
Validation | Dr. Bresalier's group will validate the turner-specific expression of lsoMSLN in adenocarcinoma of the pancreas. This will include the use of sufficient numbers of existing archival formalin-fixed specimens of adenocarcinoma of the pancreas to document expression of lsoMSLN by next generation sequencing and immunohistochemistry, including expression in carcinoma versus surrounding normal tissue. |
Collection 100 fresh-tissue samples | Collection up to 100 fresh tissue samples obtained at clinically- indicated standard-of-care endoscopic ultrasound of patients with pancreatic lesions (needle biopsy or fine needle aspiration) or at surgical resection for next generation sequencing and flow cytometry. |
Collection 100 serum plasma | Collection of serum/plasma from subjects with pancreatic cancer, normal age-matched controls and other GI cancer controls (colon, gastric, esophagus; total r= up to100) for lsoMSLN quantitative ELISA. |
ELISA+ Preparation of cell suspension | lmmunohistochemistry, ELISA and preparation of cell suspensions for flow cytometry to be performed in Dr. Bresalier's laboratory |
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List of MD Anderson Staff Committed to the Research Project
Robert S. Bresalier, M.D., Principal Investigator | Dr. Bresalier is Professor of Medicine and the Resort Distinguished Professor in GI Oncology at MD Anderson Cancer Center. He has been a leading investigator in the area of gastrointestinal tumor biology and specifically the role of glycoproteins in tumor progression and metastasis. He has been instrumental in establishing the roles of mucin-associated glycoproteins and the 13-galactoside binding protein galectin-3 in colon cancer metastasis and progression of gastrointestinal neopl3sia (colon, esophagus, pancreas), and how this may be exploited to reduce cancer-related mortality. Dr. Bresalier has extensive experience in cancer prevention and biomarker development, and translational applications which span the spectrum from laboratory studies to randomized clinical trials. He has extensive experience in the collection of clinical specimens for bio-marker development. Dr. Bresalier will oversee all of the clinical and laboratory studies outlined in the Scope of Work below, including collection of biospecimens. He will a o provide scientific guidance for experimental design, data interpretation and preparation of manuscripts. |
Senior Scientist or Research Faculty TBA | This individual should be an expert in biomarkers, immunology and targets for immunotherapy. He/she will direct all aspects of laboratory aspects of this project, including conceptualization experimental design and analysis of results. |
Margarete Hafley, Senior Research Assistant | Ms. Hafley is Senior Research Assistant at MDACC and has worked in the Bresalier laboratory for over 15 years. She has previously participated in numerous in vitro and in vivo studies related to expression and measurement of circulating and tissue-based biomarkers. She will assist with all laboratory assays in the Bresalier, Laboratory. |
Tamara Tipps, Clinical Study Coordinator | Tamara Tipps has extensive experience in coordinating trials related to biomarker validation, including projects sponsored by the EDRN. She will be responsible for the coordination of clinical sample reception, processing and |
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| registration , as well as for the Electronic Data Capture (EDC). |
Trevor Wint, Research Senior Coordinator | Trevor Wint has extensive experience in assisting with clinical trials related to biomarker validation, including projects sponsored by the EDRN. He will be responsible for assisting with clinical sample collection and processing. |
Summary of Staff Costs
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·Facility and Consumable Costs
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