CBLI on NASDAQ

Cleveland BioLabs

Logo: Statera BioPharma, Public domain, via Wikimedia Commons4

American biotechnology company

Statera BioPharma, Inc. is an American clinical-stage biopharmaceutical company with a focus on novel immunotherapies.3 From Wikipedia, CC BY-SA 4.0

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Last updated Oct 19, 2026.

Overview

2003Founded1

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  • TickerCBLI on NASDAQ1
  • IndustryPharmaceutical Preparations1
  • HeadquartersBuffalo1
  • Websitewww.cbiolabs.com
  • Incorporated inDE5
  • Business address2537 Research Boulevard, Suite 201, Fort Collins, Co 805265
  • Filer categoryNon-accelerated filer, Smaller reporting company5
  • Legal formCorporation

Statera BioPharma, Inc. is an American clinical-stage biopharmaceutical company with a focus on novel immunotherapies.3

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2021

67.2%Gross margin7
-6613.4%Operating margin7
-6849.3%Net margin7
-$28.4MFree cash flow7

Where the money goes

Where each dollar of revenue went, fiscal 2021

  • Cost of revenue4¢$488.3K
  • Research and development96¢$11.8M

Out of $1.5M in revenue.7 The company lost money this year.

Financial statements

Revenue897$1.5M in 2021+31% since 2018
0$500.0K$1.0M$1.5M2018: $1.1M$1.1M20182019: $1.1M$1.1M2019−2%2020: $0$020202021: $1.5M$1.5M2021
Gross profit7$998.7K in 2021
0$250.0K$500.0K$750.0K$1.0M2020: $0$020202021: $998.7K$998.7K2021
Operating income101112897-$98.3M in 2021+811% since 2015
-$100.0M-$75.0M-$50.0M-$25.0M02015: -$10.8M-$10.8M20152016: -$6.4M-$6.4M2016−41%2017: -$5.6M-$5.6M2017−12%2018: -$4.8M-$4.8M2018−14%2019: -$2.4M-$2.4M2019−51%2020: -$10.5M-$10.5M2020+345%2021: -$98.3M-$98.3M2021+836%
Net income101112897-$101.9M in 2021+681% since 2015
-$150.0M-$100.0M-$50.0M02015: -$13.0M-$13.0M20152016: -$2.6M-$2.6M2016−80%2017: -$9.8M-$9.8M2017+280%2018: -$3.6M-$3.6M2018−63%2019: -$2.6M-$2.6M2019−27%2020: -$12.1M-$12.1M2020+357%2021: -$101.9M-$101.9M2021+742%
Fiscal year2015201620172018201920202021
Revenue$1.1M8$1.1M9$07$1.5M7
Cost of revenue$07$488.3K7
Gross profit$07$998.7K7
Research and development$7.1M10$6.5M11$5.0M12$3.6M8$1.7M9$5.3M7$11.8M7
Operating expenses$99.3M7
Operating income-$10.8M10-$6.4M11-$5.6M12-$4.8M8-$2.4M9-$10.5M7-$98.3M7
Income tax$010$011$08$08$09$07$07
Net income-$13.0M10-$2.6M11-$9.8M12-$3.6M8-$2.6M9-$12.1M7-$101.9M7
Earnings per share-$1.667-$2.907
Shares (weighted, basic)35.1M shares7

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Leadership

Who has led Cleveland BioLabs, and when. Pick a name to see everywhere that person has worked.

Board members and other officers (40)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • DirectorBlake Kevin Hawley named Nov 7, 202261
  • DirectorJohn Kevin Kallassy named Nov 7, 202261
  • DirectorSatish Kevin Chandren named Nov 7, 202261
  • DirectorUday Kevin Saxena named Nov 7, 202261

Products and brands

Products

Entolimod (formerly Protectan) is the company's most advanced compound. It is being developed both as a radiation countermeasure and as a cancer treatment. Entolimod is being developed and tested in two contexts: as an anti-radiation pharmaceutical, under the U.S. Food and Drug Administration's animal efficacy rule, without human testing, and as an oncological, following the approval process for human pharmaceuticals. Entolimod acts through activation of Toll-like Receptor 5 to mobilize antitumor immune response and reduce radiation effects on normal tissues.

CBL0137 is a novel small molecule that modulates FACT (facilitates chromatin transcription). The interaction of CBL0137 with the FACT complex results in simultaneous NF-kB suppression, Heat Shock Factor 1 suppression and p53 activation. It demonstrated reproducible antitumor effects in animal models of colon, breast, renal, pancreatic, head and neck and prostate cancers, melanoma, non-small cell lung cancer, glioblastoma, lymphoma, leukemia and neuroblastoma.

CBL0102 is a quinacrine, a compound with a long history of use in humans as a treatment for malaria, osteoarthritis and autoimmune disorders. More recently, it has been shown that CBL0102 interferes with a novel molecular target, the FACT complex, resulting in simultaneous NF-kB suppression, Heat Shock Factor 1 suppression and p53 activation. Quinacrine has shown antitumor activity in subcutaneous human xenografts of renal cell carcinoma, prostate adenocarcinoma and fibrosarcoma. Antitumor effects of CBL0102 were shown in vitro in several human tumor cell lines including melanomas, lung adenocarcinoma, mammary gland adenocarcinoma and colon carcinoma.

CBLB612 is a proprietary compound based upon a natural activator of TLR2/TLR6 heterodimeric receptor. It structurally mimics naturally occurring lipopeptides of Mycoplasma to activate NF-kB via specific binding to TRL2, which suppresses cell death, stimulates the immune system and promotes tissue protection and regeneration. In 2009 the company assigned exclusive rights to development and marketing of CBLB612 in China to Zhejiang Hisun Pharmaceutical Co. Ltd.

Read the full text

Revercom is a preclinical cancer therapy consisting of a liposome-packaged proprietary small molecule named Reversan. Reversan is a small molecule inhibitor of the multidrug transporter MRP1, which is associated with development of tumor resistance to chemotherapy.

Mobilan is a nanoparticle-formulated, recombinant non-replicating adenovirus developed as a universal cancer therapy.

Xenomycins are antimicrobial and antifungal agents that target basic microbial transcription and replication by binding the DNA of pathogens.

Subsidiaries

Cleveland Biolabs had two majority-owned subsidiaries:

Incuron, LLC is a Russian Federation-based joint venture founded in 2010 between Russian Closed Mutual Venture Fund "Bioprocess Capital Ventures" and Cleveland BioLabs to develop product candidates CBL0102 and CBL0137 for oncology indications. As of December 31, 2013, Cleveland BioLabs owned %59.2 of Incuron.

Panacela Labs, Inc. is a joint venture company founded in 2011 by Cleveland BioLabs and Open Joint Stock Company Rusnano in conjunction with Roswell Park Cancer Institute, Children's Cancer Institute Australia and Cleveland Clinic Foundation. As of December 31, 2013, Cleveland BioLabs owned 54.6% of Panacela.

From Wikipedia’s article on Statera BioPharma, shared under CC BY-SA 4.0.6

Former names

  • Cytocom, Inc.Jul 29, 2021 to Aug 17, 20215
  • CLEVELAND BIOLABS INCFeb 18, 2005 to Jul 28, 20215

Timeline

  1. Aug 4, 2021New chief executive Michael K. Handley becomes CEO16
  2. Jan 25, 2012New chief executive Yakov Kogan becomes CEO17
  3. Jul 20, 2006New chief executive Michael Fonstein becomes CEO18
  4. 2003Founded Founded1

Filings

56 filings to the SEC since October 2021: 1 annual reports, 4 quarterly reports, 33 major events, 4 insider forms, 1 large holders, 1 private raises, 12 other. The latest 20:

  1. Mar 3, 202325-NSE EDGAR
  2. Mar 1, 2023DEFR14A EDGAR
  3. Feb 27, 2023DEF 14A EDGAR
  4. Feb 14, 2023PRE 14A PRE14A EDGAR
  5. Feb 1, 20238-K EDGAR
  6. Feb 1, 20238-A12G EDGAR
  7. Jan 20, 20238-K EDGAR
  8. Nov 28, 2022DEF 14A EDGAR
  9. Nov 18, 2022PRE 14A PRE14A EDGAR
  10. Nov 15, 20228-K EDGAR
  11. Nov 14, 202210-Q EDGAR
  12. Nov 7, 20228-K EDGAR
  13. Nov 7, 2022D EDGAR
  14. Oct 28, 202210-Q EDGAR
  15. Oct 27, 20228-K EDGAR
  16. Oct 24, 20228-K EDGAR
  17. Oct 21, 202210-Q EDGAR
  18. Oct 17, 20228-K EDGAR
  19. Oct 6, 202210-K EDGAR
  20. Sep 27, 20228-K EDGAR

The 56 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Nov 1, 2022Raised $577,000 in a private offering of equity Form D: $764,500 offered in all Form D

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