On August 16, 2021 Cytocom, Inc. (Nasdaq: CBLI), a leading biopharmaceutical company creating next-generation immune therapies for serious medical conditions that induce immune restoration and homeostasis, reported recent corporate updates and financial results for the Company for the second quarter ended June 30, 2021, a period of time prior to the completion of the merger between legacy Cleveland BioLabs and the formerly private Cytocom Inc (Press release, Cytocom, AUG 16, 2021, https://www.cytocom.com/2021/08/16/cytocom-inc-reports-second-quarter-2021-financial-results/?utm_source=rss&utm_medium=rss&utm_campaign=cytocom-inc-reports-second-quarter-2021-financial-results [SID1234586606]). Following the completion of the merger on July 27, 2021, Cytocom, Inc. emerged as a publicly traded entity.

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"The first half of 2021 and recent weeks have demonstrated management’s commitment to driving shareholder value by executing transactions that have been transformative for Cytocom," stated Michael K. Handley, President and CEO of Cytocom. "Following the successful merger between legacy Cleveland BioLabs and the formerly private Cytocom Inc., we believe we are well financed and positioned to become a dominant player in the field of immune-modulation, with one of the largest platforms of toll-like receptors in the biopharmaceuticals industry."

Mr. Handley commented, "Our clinical- and development-stage pipeline has never been stronger and showcases greatly enhanced drug development capabilities that should drive future growth. A research alliance with the La Jolla Institute of Immunology will harness Cytocom’s pipeline of next-generation immunotherapies to advance discovery work that could add new assets to a pipeline already exploring eight drug candidates across 21 indications. By mid-2022, we expect to be enrolling patients in several clinical trials, including a Phase 3 trial for our lead drug candidate, CYTO-201, in pediatric Crohn’s disease, Phase 1b/2 trials for CYTO-205 as a treatment for acute and ‘long-haul’ COVID-19 and a Phase 1b/2 clinical trial for CYTO-401 in pancreatic cancer."

Mr. Handley continued, "Beyond our clinical-stage assets, we are exploring opportunities for the immune-stimulatory toll-like receptor 5 agonist, entolimod, and its next-generation molecule, GP532. These were the core assets inherited from Cleveland BioLabs and our team is already at work devising a plan to develop entolimod/GP532 for the multibillion-dollar hematologic market, specifically as a treatment for chronic or acute neutropenia and anemia in cancer patients. We anticipate a clinical trial could initiate later this year."

Recent Corporate Updates:

The Company’s common stock began trading on Nasdaq under the post-merger name, Cytocom, Inc., with the current ticker symbol "CBLI" at the opening bell on July 28, 2021.
Secured commitments for capital with agreements providing for $90 million in debt and equity financing to continue advancing the Company’s product pipeline.
Financing led by $75 millionequity commitment fromGEM Global Yield LLC SCSand joined by $17 million debt and equity financing from Avenue Capital and Adit Ventures.
The merger created an immunotherapy company with 21 development- and clinical-stage programs across eight different assets.
The merger joined two companies, each harnessing a different and promising technology focused on delivering immune therapies for oncology, emerging viruses and other indications. With Cytocom’s TLR4 and TLR9 antagonists, and the TLR5 agonists, entolimod and GP532, Cytocom now has one of the largest platforms of toll-like receptors (TLR) in the biopharmaceutical industry.
Research alliance with La Jolla Institute for Immunology to leverage world-class research infrastructure and Cytocom’s proprietary AIMS discovery platform to research potential new immune-modulating agents for the treatment of cancer, emerging viruses, autoimmune disorders, and hematological diseases.
Advance clinical programs for Crohn’s disease, anemia/neutropenia, COVID-19 and pancreatic cancer.
Productive end-of-Phase 2 meeting completed for CYTO-201 in pediatric Crohn’s disease; Patient enrollment in Phase 3 trial expected to begin by year-end 2021.
Reviewing the research and development pipeline inherited from Cleveland BioLabs. The Company plans to evaluate ongoing development requirements and medical needs of the toll-like receptor 5 agonist, entolimod, in radiation emergencies.
Exploring new indications for entolimod and we are excited about the potential for toll-like receptor 5 agonists in treating neutropenia and anemia in cancer patients.
Completed Type C meeting for clinical trial exploring CYTO-401 in late-stage, non-resectable pancreatic cancer patients expected in the first half of 2022.
Phase 1b/2 trials for CYTO-205 in acute and post-acute COVID-19 expected to enroll patients by year-end 2021.
Mr. Handley concluded, "In terms of our financial and cash position, Cytocom is well capitalized. The commitments for $90 million in debt and equity financing from GEM Global Yield LLC SCS, Avenue Capital, and Adit Ventures should provide capital to advance growth initiatives, further development of the company’s internal pipeline, and allow us to build on the momentum of recent weeks. Our listing on Nasdaq should raise our visibility among the investment community and public markets, enhance trading liquidity and drive long-term shareholder value."

Second Quarter Financial Results:

The Company did not generate revenue during the second quarter of 2021, compared to $0.06 million in revenue for the second quarter of 2020. The decrease was attributable to the cessation of revenue from the Company’s Joint Warfighter Medical Research Program contract from the Department of Defense (DoD) for the continued development of entolimod as a medical radiation countermeasure, the cessation of revenue from the Company’s Peer Reviewed Medical Research Program from the DoD for clinical development of entolimod as a medical radiation countermeasure, and the cessation of revenue from its service contract with Incuron.
Research and development costs for the second quarter of 2021 decreased to $0.05 million compared to $0.17 million for the second quarter of 2020. The reduction in research and development costs was due to a $0.12 million decrease in expenses related to the biodefense applications of entolimod.
General and administrative costs for the second quarter of 2021 increased to $0.6 million compared to $0.5 million for the second quarter of 2020. This increase was primarily attributable to a $0.1 million increase in legal and professional fees arising from the merger.
Net loss for the quarter ended June 30, 2021, increased to $(0.7) million, excluding minority interests, for the second quarter of 2021, or $(0.04) per share, compared to a net loss, excluding minority interests, of $(0.4) million, or $(0.03) per share, for the same period in 2020. The increase in net loss was primarily due to a reduction in other income attributable to a one-time event experienced in 2020, an increase in general and administrative costs, and reduced revenue, partially offset by a reduction in research and development expenses, and a decrease in the non-cash adjustment to the Company’s warrant liabilities.
The Company has approximately $23 million in cash on hand and expects its cash position to increase to $30 million by the end of August 2021 with commitments to an additional $60 million under the Company’s debt and equity arrangements with GEM Global Yield LLC SCS and Avenue Venture Opportunities Fund, L.P. The Company believes this, and other capital sources are sufficient to fund the continued advancement of the Company’s clinical-stage pipeline and drive Cytocom toward multiple value infection points.
Conference Call and Webcast Details
Cytocom will host a conference call and live audio webcast Monday, August 16, at 8:30 a.m. ET to discuss these financial results and provide a business update.

A live webcast and audio archive for the event may be accessed from the "Investors" section of the Cytocom website at https://www.cytocom.com/investors/. A replay of the webcast will be archived on the website for 90 days beginning at approximately10:00 a.m. ET, onAugust 16, 2021.