On November 15, 2021 Statera Biopharma, Inc. (Nasdaq: STAB), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, reported important corporate events and financial results for the third quarter ended September 30, 2021 (Press release, Cleveland BioLabs, NOV 15, 2021, View Source [SID1234595606]). Statera Biopharma was formerly known as Cleveland BioLabs, Inc. and merged with Cytocom Inc. on July 27, 2021.

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"We are pleased with our operational progress to integrate the portfolio and advance our clinical programs as we prepare to initiate several clinical trials during 2022, including a pivotal Phase 3 trial for our lead drug candidate, STAT-201, in pediatric Crohn’s disease, as well as studies of the TLR5 agonist Entolimod as a treatment for anemia and neutropenia in cancer patients, broaden the STAT-205 program to post-acute COVID-19 and study STAT-401 in pancreatic cancer," said Michael K. Handley, Chief Executive Officer of Statera Biopharma. "We also expect to further strengthen our cash position to support funding the continued advancement of the Company’s clinical-stage pipeline and drive Statera Biopharma toward multiple value infection points. We may also raise additional funding to capitalize on what we believe are myriad internal and external opportunities in the field of immune modulation and bring hope to patients and their families."

Recent Business and Corporate Highlights:

Statera Biopharma, Inc. changed its corporate name from Cytocom, Inc. on September 1, 2021, and ticker symbol for common stock was updated from "CBLI" to "STAB".
Merger created a company with one of the largest platforms of toll-like immune receptor (TLR) agonists in the biopharmaceutical industry. The expanded pipeline includes TLR4, TLR8 and TLR9 molecules, and the TLR5 agonists, Entolimod and GP532.
Statera Biopharma continues to advance its clinical- and development-stage pipeline.
Enrollment is expected to begin by the end of 2021 at Loma Linda University Health for Phase 1 pilot study evaluating STAT-205 as a treatment to mitigate progression of SARS-CoV-2, the virus that causes COVID-19.
End-of-Phase 2 meeting completed July 2021 for STAT-201 in pediatric Crohn’s disease; Site selection and set up proceeding in fourth quarter of 2021 and Pivotal Phase 3 trial expected to begin enrollment in the first quarter of 2022.
Clinical trials for STAT-401 in pancreatic cancer and STAT-600 (Entolimod) in hematologic indications expected in 2022.
Utilized a portion of capital commitments for debt and equity financing secured prior to the merger to fund growth initiatives and advance internal pipeline.
Utilized $7.7 million of the debt facility in the third quarter.
Statera has additional funding capacity under these facilities, which will provide the Company with working capital to continue pipeline development.
The Company expects to close further funding commitments by year end.
Harnessing scientific capabilities and new research alliances to advance discovery and development of second-generation pipeline assets
Screening of new immune compounds underway; using tools and capabilities of its subsidiary ImQuest Life Sciences to determine which compounds are likely to succeed in preclinical and clinical trials.
Research alliance with La Jolla Institute for Immunology has Statera Biopharma funding four laboratories and selected research projects that will use Statera’s platform technologies to discover new immune-modulating agents targeting toll-like immune receptors to address cancer, autoimmune conditions, and infectious diseases.
Financial Results

Form 10-Q filed today is first opportunity for Statera Biopharma to present consolidated financial reports covering the results of Cytocom, Cleveland BioLabs, and ImQuest combined.
Under GAAP applicable to the mergers, the financial presentation covers:
Income statement for the merged companies only from their respective merger dates;
Statements of Assets and Liabilities in the balance sheets only from their respective merger dates;
The Income statements and statements of Assets and Liabilities for periods prior to June 24, 2021 cover old Cytocom only;
Statements of Equity for all periods cover old Cleveland BioLabs and old Cytocom from a legal and accounting survivor, respectively, as a result of the merger.
Highlights of the three three-month period ended September 30, 2021 were:
Revenues of $0.24 million from research services provided by the ImQuest subsidiary to its customers. Cost of revenues was $0.12 million, resulting in a gross profit of $0.12 million. No revenues or expenses are included in the period for old Cytocom or old Cleveland BioLabs. There were no revenues in the same period in 2020.
A net loss of $12.7 million, or ($0.47) per share, compared to a net loss of $5.7 million, or ($1.84) per share for the same period in 2020.
R&D expenses decreased from $4.38 million for the three months ended September 30, 2020 to $3.43 million for the three months ended September 30, 2021, a 21.6% decrease. The decrease is primarily attributable to a $3.8 million decrease in one-time patent expenses for the three months ended September 30, 2020 related to the transfer of intellectual property to the Company by Immune Therapeutics, Inc., partially offset by a $1.6 million increase in expenses associated with STAT-201: Crohn’s disease, $0.4 million increase in expenses associated with STAT-401: Pancreatic cancer, and $1.0 million increase in non-program specific expenses.
G&A expenses increased from $1.8 million for the three months ended September 30, 2020 to $6.3 million for the three months ended September 30, 2021, an increase of 252.8%. This increase is primarily related to a $2.6 million increase in payroll expenses of which $1.9 million was for stock-based compensation, a $0.6 million increase in stock listing expenses, a $0.2 million increase in professional fees, and a $1.1 million increase in consultants, insurance, and other general expenses.
In the nine months ended September 30, 2021, the Company used $20.1 million of cash in operating activities. It funded these operations with:
$13.6 million provided by investing activities, primarily from the net assets acquired in the merger with Cleveland BioLabs;
$20.1 million provided by financing activities, in particular net proceeds of $14.7 million from a $15.0 million note issued to Avenue Ventures and $5.7 million due to the issuance of common stock, partially offset by repayments in notes payable and payment of debt issuance costs of $0.4 million.
At September 30, 2021, Statera BioPharma reported cash, cash equivalents, and restricted cash of $14.4 million, an increase of $13.8 million over the $0.6 million reported at the end of 2020.
Conference Call & Audio Webcast Details
Statera Biopharma, Inc. will host a conference call and live audio webcast on Monday, November 15, 2021, at 5:30 p.m. ET, to discuss its corporate and financial results for the third quarter 2021.

Live Audio Webcast View Source
An audio webcast will be accessible via the Investors section of the Company’s website View Source An archive of the webcast will remain available for 90 days beginning at approximately 6:30 p.m. ET, on November 15, 2021.