Herold
2 years ago
Statera Biopharma (Nasdaq: STAB) (the "Company"), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, announced today that the Company entered into a non-binding term sheet with respect to a strategic agreement with Immune Therapeutics, Inc. (OTC-PINK: IMUN), a drug development and commercialization company, to sell Statera's rights to naltrexone and met-enkephalin. The transaction is contingent upon negotiation of a definitive agreement and satisfaction of a number of closing conditions, including a contingency on Immune Therapeutics financing.
"The agreement with Immune will enable us to strengthen our financial position with a transaction that has the potential to produce significant non-dilutive cashflow to fund our other programs. For instance, Statera is beginning to chart a new course in the immunotherapy field by pursuing molecules that act on Toll-like Receptor pathways similar to Naltrexone," said Michael K. Handley, President and Chief Executive Officer of Statera Biopharma. "It also will help advance our new product candidates for treatment of a variety of immune-related diseases that have no cure."
Under the anticipated terms of the agreement, Statera will receive an initial $2 million upfront payment and 5% of the issued and outstanding stock of Immune Therapeutics. Additionally, Statera will receive payments for achievement of revenue-based milestones, new indications and royalties, Crohn's disease and COVID-19 indications and regulatory approvals, as well as any other payments from Immune Therapeutics in exchange for Statera's rights to any product containing low-dose naltrexone as an active ingredient. Potential indication payments will include asthma, multiple sclerosis, HIV and chemotherapy. In aggregate, this transaction has the ability to generate over $400 million in non-dilutive payments to Statera.
"Statera's naltrexone assets will be a great addition to our immune-modulation products and immunotherapy technologies," said Kevin Phelps, CEO, Immune Therapeutics. "We believe that they can significantly enhance our ability to combat chronic, lifeâ?threatening diseases and bring hope to millions of patients and their families."
goforthebet
3 years ago
Cytocom, Inc. and La Jolla Institute for Immunology Announce
Five-Year Research Alliance Agreement
Cytocom to fund research in cancer, autoimmune and inflammatory conditions, and infectious diseases and applications to clinical-stage therapies
Research to accelerate immune-modulating drug development, leveraging world-class research infrastructure and Cytocom’s proprietary AIMS™ discovery platform
FORT COLLINS, Colo., August 12, 2021 /PRNewswire/ -- Cytocom, Inc. (NASDAQ: CBLI), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, today announced a collaboration agreement to fund research and laboratory facilities at the La Jolla Institute for Immunology (LJI), a not-for-profit academic institution and a world leader in immunology research. The agreement is directed to research that will support the development of potential new immune-modulating agents targeting toll-like receptors for the treatment of cancer, infectious, autoimmune and chronic inflammatory diseases. The research will harness Cytocom’s proprietary drug discovery and development platform technology.
“An alliance with an academic institution the caliber of the La Jolla Institute marks a major achievement for Cytocom and our mission to advance best-of-class immune-modulating therapies that restore immune homeostasis,” stated Michael K. Handley, President and CEO of Cytocom. “With the completion of the merger between Cleveland BioLabs and Cytocom, we have built a robust pipeline of immune-modulating treatments targeting neutropenia and anemia, emergent viruses, cancer, and autoimmune diseases. Working with the La Jolla Institute, we will deeply explore the mechanisms that we believe will drive next-generation therapeutic development with our AIMS™ technology and bring hope to patients and their families battling serious medical conditions.”
Under the terms of the research agreement, the La Jolla Institute may select up to four laboratories to participate in research. Cytocom will provide research funding to these laboratories for projects of mutual interest or for research projects commissioned by Cytocom that explore immune modulation and the action of therapeutics on target toll-like receptors. Toll-like receptors are central to an immune response, connecting innate and adaptive immune compartments, and thus key to fighting disease as well as restoring immune homeostasis. In addition to the research funding for the selected projects, Cytocom will pay to the La Jolla Institute $350,000 per year for each selected laboratory, for a total annual discretionary funding contribution of up to $1.4 million, in addition to the research funding itself. Cytocom will also provide researchers at the La Jolla Institute with samples and materials. In return, Cytocom will have a first option to negotiate a license to new discoveries by the La Jolla Institute that arise from the research projects of common interest funded by Cytocom, however Cytocom will own any new discoveries that arise from research projects of interest to Cytocom that have been commissioned to the La Jolla Institute as “work for hire.”
“We are excited to work with Cytocom to interrogate the mechanisms of immune modulation and human immunity modulated through toll-like receptors,” stated La Jolla Institute President and Chief Scientific Officer Mitchell Kronenberg, Ph.D. “Collaborations between academic research organizations and the biopharmaceutical industry play a key role in advancing science and informing drug development to the benefit everyone involved, from discovery-oriented scientists to therapeutic-oriented companies. Such collaborations are an important element of our history and our mission looking to the future. Most importantly, the combined efforts provide hope to the millions of people worldwide who deserve immunotherapies that deliver a healthy life without disease.”
About the La Jolla Institute for Immunology
Founded in 1988, La Jolla Institute for Immunology is a nonprofit, independent biomedical research institute focused on improving human health through increased understanding of the immune system. Its scientists carry out research seeking new knowledge leading to the prevention of disease through vaccines and the treatment and cure of infectious diseases, cancer, inflammatory, and autoimmune diseases such as rheumatoid arthritis, type 1 (juvenile) diabetes, Crohn’s disease and asthma. To learn more about the Institute’s work, visit www.lji.org.
About Cytocom
Cytocom, Inc. is a clinical-stage biopharmaceutical company developing novel immunotherapies targeting autoimmune, neutropenia/anemia, emerging viruses and cancers based on a proprietary platform designed to rebalance the body’s immune system and restore homeostasis. The company also has one of the largest platforms of toll-like immune receptors (TLR4, TLR5 and TLR9) in the biopharmaceutical industry, addressing conditions such as radiation sickness and cancer treatment side effects. Cytocom is developing therapies designed to elicit directly within patients a robust and durable response of antigen-specific killer T-cells and antibodies, thereby activating essential immune defenses against autoimmune, inflammatory, infectious diseases, and cancers. Specifically, Cytocom has several clinical-stage development programs for Crohn’s disease, hematology, pancreatic cancer, and COVID-19 in addition to expansion to fibromyalgia and multiple sclerosis. To learn more about Cytocom, Inc., please visit www.cytocom.com.
Forward Looking Statements:
This press release contains forward-looking statements that involve risks and uncertainties. All statements other than statements of current or historical fact contained in this press release, including statements regarding the expected clinical development timeline for our product candidates, our future financial position, business strategy, new products, budgets, liquidity, cash flows, projected costs, regulatory approvals, the impact of any laws or regulations applicable to the company, and plans and objections of management for future operations, are forward-looking statements. The words "anticipate," "believe," "continue," "should," "estimate," "expect," "intend," "may," "plan," "project," "will," and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements on the current expectations about future events held by management. While we believe these expectations are reasonable, such forward-looking statements are inherently subject to risks and uncertainties, many of which are beyond our control. The company’s actual future results may differ materially from those discussed here for various reasons. The company discusses many of these risks under the heading "Risk Factors" in the proxy statement/prospectus filed with the SEC on June 10, 2021, as updated by the company’s other filings with the SEC. Factors that may cause such differences include, but are not limited to, the outcome of any legal proceedings that have been or may be instituted against the company related to the merger between legacy Cytocom and Cleveland BioLabs; unexpected costs, charges or expenses resulting from the merger; our need for additional financing to meet our business objectives; our history of operating losses; our ability to successfully develop, obtain regulatory approval for, and commercialize our products in a timely manner; our plans to research, develop and commercialize our product candidates; our ability to attract collaborators with development, regulatory and commercialization expertise; our plans and expectations with respect to future clinical trials and commercial scale-up activities; our reliance on third-party manufacturers of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; the rate and degree of market acceptance of our product candidates; regulatory requirements and developments in the United States, the European Union and foreign countries; the performance of our third-party suppliers and manufacturers; the success of competing therapies that are or may become available; our ability to attract and retain key scientific or management personnel; our historical reliance on government funding for a significant portion of our operating costs and expenses; government contracting processes and requirements; the exercise of significant influence over our company by our largest individual stockholder; the impact of the novel coronavirus ("COVID-19") pandemic on our business, operations and clinical development; the geopolitical relationship between the United States and the Russian Federation as well as general business, legal, financial and other conditions within the Russian Federation; our ability to obtain and maintain intellectual property protection for our product candidates; our potential vulnerability to cybersecurity breaches; and other factors discussed in our SEC filings, including our Annual Report on Form 10-K for the year ended December 31, 2020 and the risk factors discussed under the heading “Risk Factors” in the proxy statement/prospectus the company filed in connection with the merger on June 10, 2021.
Given these uncertainties, you should not place undue reliance on these forward-looking statements. The forward-looking statements included in this press release are made only as of the date hereof. We do not undertake any obligation to update any such statements or to publicly announce the results of any revisions to any of such statements to reflect future events or developments.
Contacts:
Cytocom, Inc.
Nichol Ochsner
Senior V.P. Investor Relations and Corporate Communications
(732) 754-2545
nichol.ochsner@cytocom.com
Tiberend Strategic Advisors, Inc.
Maureen McEnroe, CFA (Investors)
(212) 375-2664
mmcenroe@tiberend.com
Johanna Bennett (Media)
(212) 375-2686
jbennett@tiberend.com
goforthebet
3 years ago
2021-08-11 07:30:00 ET (1 hour ago)
Cytocom, Inc. Announces Participation at Liberty University's Empowering the Kingdom Through Business Conference
FORT COLLINS, Colo., Aug. 11, 2021 /PRNewswire/ -- Cytocom, Inc. (NASDAQ: CBLI), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, today announced that the company will participate at the Empowering the Kingdom through Business Conference hosted by the Liberty University School of Business on August 10-12, 2021. Cytocom President and CEO, Mike K. Handley, will participate live as a featured panelist in the Healthcare Breakout session moderated by Dean Joseph Johnson on August 11, 2021.
About Cytocom
Cytocom, Inc. is a clinical-stage biopharmaceutical company developing novel immunotherapies targeting autoimmune, neutropenia/anemia, emerging viruses and cancers based on a proprietary platform designed to rebalance the body's immune system and restore homeostasis. The company also has one of the largest platforms of toll-like immune receptors (TLR4, TLR5 and TLR9) in the biopharmaceutical industry, addressing conditions such as radiation sickness and cancer treatment side effects. Cytocom is developing therapies designed to elicit directly within patients a robust and durable response of antigen-specific killer T-cells and antibodies, thereby activating essential immune defenses against autoimmune, inflammatory, infectious diseases, and cancers. Specifically, Cytocom has several clinical-stage development programs for Crohn's disease, pancreatic cancer, COVID-19 in addition to expansion to fibromyalgia and multiple sclerosis. To learn more about Cytocom, Inc., please visit www.cytocom.com.
Forward Looking Statements:
This press release contains forward-looking statements that involve risks and uncertainties. All statements other than statements of current or historical fact contained in this press release, including statements regarding our future financial position, business strategy, new products, budgets, liquidity, cash flows, projected costs, regulatory approvals, the impact of any laws or regulations applicable to the company, and plans and objectives of management for future operations, are forward-looking statements. The words "anticipate," "believe," "continue," "should," "estimate," "expect," "intend," "may," "plan," "project," "will," and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements on the current expectations about future events held by management. While we believe these expectations are reasonable, such forward-looking statements are inherently subject to risks and uncertainties, many of which are beyond our control. The company's actual future results may differ materially from those discussed here for various reasons. The company discusses many of these risks under the heading "Risk Factors" in the proxy statement/prospectus filed with the SEC on June 10, 2021, as updated by the company's other filings with the SEC. Factors that may cause such differences include, but are not limited to, the outcome of any legal proceedings that have been or may be instituted against the company related to the merger between Cytocom and Cleveland BioLabs; unexpected costs, charges or expenses resulting from the merger; our need for additional financing to meet our business objectives; our history of operating losses; our ability to successfully develop, obtain regulatory approval for, and commercialize our products in a timely manner; our plans to research, develop and commercialize our product candidates; our ability to attract collaborators with development, regulatory and commercialization expertise; our plans and expectations with respect to future clinical trials and commercial scale-up activities; our reliance on third-party manufacturers of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; the rate and degree of market acceptance of our product candidates; regulatory requirements and developments in the United States, the European Union and foreign countries; the performance of our third-party suppliers and manufacturers; the success of competing therapies that are or may become available; our ability to attract and retain key scientific or management personnel; our historical reliance on government funding for a significant portion of our operating costs and expenses; government contracting processes and requirements; the exercise of significant influence over our company by our largest individual stockholder; the impact of the novel coronavirus ("COVID-19") pandemic on our business, operations and clinical development; the geopolitical relationship between the United States and the Russian Federation as well as general business, legal, financial and other conditions within the Russian Federation; our ability to obtain and maintain intellectual property protection for our product candidates; our potential vulnerability to cybersecurity breaches; and other factors discussed in our SEC filings, including our Annual Report on Form 10-K for the year ended December 31, 2020 and the risk factors discussed under the heading "Risk Factors" in the proxy statement/prospectus the company filed in connection with the merger on June 10, 2021.
Given these uncertainties, you should not place undue reliance on these forward-looking statements. The forward-looking statements included in this press release are made only as of the date hereof. We do not undertake any obligation to update any such statements or to publicly announce the results of any revisions to any of such statements to reflect future events or developments.
Contacts:
Cytocom, Inc.
Nichol Ochsner
Senior V.P. Investor Relations and Corporate Communications
(732) 754-2545
[email hidden - please find in source]
Tiberend Strategic Advisors, Inc.
Maureen McEnroe, CFA (Investors)
(212) 375-2664
[email hidden - please find in source]
Johanna Bennett (Media)
(212) 375-2686
[email hidden - please find in source]
SOURCE Cytocom Inc.
goforthebet
3 years ago
Cytocom, Inc. to Report Second Quarter 2021 Financial Results
Executive Management to Host Conference Call on Monday, August 16th at 8:30 a.m. ET
FORT COLLINS, Colo., August 10, 2021 /PRNewswire/ -- Cytocom, Inc. (NASDAQ: CBLI), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, today announced that the Company will host a conference call and live audio webcast on Monday, August 16, 2021, at 8:30 a.m. ET, to discuss its corporate and financial results for the second quarter 2021.
Conference Call & Audio Webcast Details
Date
Monday, August 16, 2021
Time
8:30 a.m. ET
Telephone Access: U.S. and Canada
833-317-6003
Telephone Access: International
412-317-6061
Access Code for All Callers
3735775
Live Audio Webcast
https://www.cytocom.com/investors/
See “Investors & Media” Section
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/. Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be archived on the website for 90 days beginning at approximately 10:00 a.m. ET, on August 16, 2021.
About Cytocom
Cytocom, Inc. is a clinical-stage biopharmaceutical company developing novel immunotherapies targeting autoimmune, neutropenia/anemia, emerging viruses and cancers based on a proprietary platform designed to rebalance the body’s immune system and restore homeostasis. The company also has one of the largest platforms of toll-like immune receptors (TLR4, TLR5 and TLR9) in the biopharmaceutical industry, addressing conditions such as radiation sickness and cancer treatment side effects. Cytocom is developing therapies designed to elicit directly within patients a robust and durable response of antigen-specific killer T-cells and antibodies, thereby activating essential immune defenses against autoimmune, inflammatory, infectious diseases, and cancers. Specifically, Cytocom has several clinical-stage development programs for Crohn’s disease, pancreatic cancer, COVID-19 in addition to expansion to fibromyalgia and multiple sclerosis. To learn more about Cytocom, Inc., please visit www.cytocom.com.
Forward Looking Statements:
This press release contains forward-looking statements that involve risks and uncertainties. All statements other than statements of current or historical fact contained in this press release, including statements regarding our future financial position, business strategy, new products, budgets, liquidity, cash flows, projected costs, regulatory approvals, the impact of any laws or regulations applicable to the company, and plans and objectives of management for future operations, are forward-looking statements. The words "anticipate," "believe," "continue," "should," "estimate," "expect," "intend," "may," "plan," "project," "will," and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements on the current expectations about future events held by management. While we believe these expectations are reasonable, such forward-looking statements are inherently subject to risks and uncertainties, many of which are beyond our control. The company’s actual future results may differ materially from those discussed here for various reasons. The company discusses many of these risks under the heading "Risk Factors" in the proxy statement/prospectus filed with the SEC on June 10, 2021, as updated by the company’s other filings with the SEC. Factors that may cause such differences include, but are not limited to, the outcome of any legal proceedings that have been or may be instituted against the company related to the merger between Cytocom and Cleveland BioLabs; unexpected costs, charges or expenses resulting from the merger; our need for additional financing to meet our business objectives; our history of operating losses; our ability to successfully develop, obtain regulatory approval for, and commercialize our products in a timely manner; our plans to research, develop and commercialize our product candidates; our ability to attract collaborators with development, regulatory and commercialization expertise; our plans and expectations with respect to future clinical trials and commercial scale-up activities; our reliance on third-party manufacturers of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; the rate and degree of market acceptance of our product candidates; regulatory requirements and developments in the United States, the European Union and foreign countries; the performance of our third-party suppliers and manufacturers; the success of competing therapies that are or may become available; our ability to attract and retain key scientific or management personnel; our historical reliance on government funding for a significant portion of our operating costs and expenses; government contracting processes and requirements; the exercise of significant influence over our company by our largest individual stockholder; the impact of the novel coronavirus ("COVID-19") pandemic on our business, operations and clinical development; the geopolitical relationship between the United States and the Russian Federation as well as general business, legal, financial and other conditions within the Russian Federation; our ability to obtain and maintain intellectual property protection for our product candidates; our potential vulnerability to cybersecurity breaches; and other factors discussed in our SEC filings, including our Annual Report on Form 10-K for the year ended December 31, 2020 and the risk factors discussed under the heading “Risk Factors” in the proxy statement/prospectus the company filed in connection with the merger on June 10, 2021.
Given these uncertainties, you should not place undue reliance on these forward-looking statements. The forward-looking statements included in this press release are made only as of the date hereof. We do not undertake any obligation to update any such statements or to publicly announce the results of any revisions to any of such statements to reflect future events or developments.
Contacts:
Cytocom, Inc.
Nichol Ochsner
Senior V.P. Investor Relations and Corporate Communications
(732) 754-2545
nichol.ochsner@cytocom.com
Tiberend Strategic Advisors, Inc.
Maureen McEnroe, CFA (Investors)
(212) 375-2664
mmcenroe@tiberend.com
Johanna Bennett (Media)
(212) 375-2686
jbennett@tiberend.com
goforthebet
3 years ago
Cytocom Inc. Provides Updates on Key Clinical Programs for Crohn’s Disease, Hematology, Pancreatic Cancer and COVID-19
Patient enrollment in Phase 3 pediatric Crohn’s disease trial expected to initiate by year-end 2021; End-of-Phase 2 meeting successfully completed in July
Exploring development of entolimod in hematology indications
Plan to initiate a clinical trial exploring CYTO-401 in pancreatic cancer in 1H22
Plan to study CYTO-205 in patients with acute and post-acute COVID-19
FORT COLLINS, Colo., August 9, 2021 /PRNewswire/ -- Cytocom Inc. (Nasdaq: CBLI), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, today provided an update regarding its portfolio of clinical programs.
“We are excited and believe that we are well positioned to further the development of our clinical-stage pipeline and showcase the power of our expanded post-merger drug development capabilities,” stated Michael K. Handley, President and CEO of Cytocom. “We are strategically focused on immune-modulating treatments designed to address anemia and neutropenia, emergent viruses, cancer, and autoimmune diseases.”
Mr. Handley continued, “The coming months will be busy. We are completing the necessary steps to begin enrolling patients by year-end 2021 in a Phase 3 clinical trial for our lead drug candidate, CYTO-201, for the treatment of Crohn’s disease. Building on our legacy Cytocom pipeline are the Cleveland BioLabs assets, specifically entolimod, an immune-stimulatory agent. We are eager to explore new indications for entolimod and remain excited about the potential for toll-like receptor 5 agonists in treating neutropenia and anemia in cancer patients. Our team is working to put together development plans in hematology and we are in talks with a renowned medical facility to begin a clinical study using entolimod in the coming months.”
Mr. Handley concluded, “In addition, we plan to follow in the first half of 2022 with a clinical trial exploring CYTO-401 as an adjunct to standard of care therapy to extend the duration of disease remission in patients with pancreatic cancer. We are also completing the necessary steps to activate clinical trial sites and begin enrolling patients in clinical trials exploring CYTO-205 in patients with acute and post-acute COVID-19. This could be a particularly compelling opportunity given the pernicious nature of the SARS-CoV-2 virus, which, despite growing vaccination rates, continues to impact millions of people worldwide. What’s more, the medical community has specifically expressed interest on a “long haulers” study.”
CYTO-201 and Crohn's Disease
Cytocom's lead investigational drug candidate, CYTO-201, is being studied for the treatment of pediatric patients with Crohn's disease, an inflammatory bowel disease that causes chronic inflammation of the gastrointestinal (or digestive) tract, causing symptoms such as persistent diarrhea, abdominal pain and rectal bleeding. Studies show that because the signs and symptoms of the disease are unpredictable, patients living with the disease endure significant burdens, not only physical, but also emotional and economic.
On July 27, 2021, Cytocom completed a successful end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding a clinical development plan for a Phase 3 clinical trial evaluating CYTO-201 in pediatric Crohn’s patients. Cytocom is partnering with ICON plc (NASDAQ: ICLR), a global contract research organization (CRO), to manage the trial, and expects to begin enrolling patients by year-end 2021.
Entolimod and Hematology
Cytocom’s new management team is now reviewing information regarding the past development work for entolimod, as well as previous clinical trial data. The company plans to address the clinical hold imposed by the U.S. Food and Drug Administrations (FDA) in 2019 in order to initiate clinical trials for new indications. In addition to continuing work on the Acute Radiation Syndrome or ARS, Cytocom plans to explore new indications for entolimod based on the potential of toll-like receptor 5 agonists in hematology indications, specifically the treatment of neutropenia and anemia in cancer patients. Cytocom is developing a hematology program and discussions are underway with a renowned academic institution to potentially initiate the first study later this year using entolimod in a hematology indication.
CYTO-401 and Pancreatic Cancer
Cytocom is developing CYTO-401 as an adjunct to standard of care therapy to extend the duration of disease remission in patients with pancreatic cancer. In August 2021, the company received FDA feedback regarding the clinical development program. Having feedback on the development program and establishing an advisory panel of oncology experts, Cytocom is now evaluating contract research organizations (CROs) and is planning to initiate the clinical trial in the first half of 2022.
CYTO-205 and Acute and Post-Acute COVID-19
With the FDA having cleared an Investigational New Drug (IND) application, Cytocom expects to begin a Phase 2 clinical trial in the third quarter of 2021 to evaluate the safety and efficacy of CYTO-205 to slow or halt the progression of the SARS-CoV-2, the virus that causes COVID-19.
Cytocom is finalizing protocols for a study evaluating CYTO-205 in patients with post-acute COVID-19 syndrome (PACS). Also known as “long haulers,” these patients represent a high unmet medical need with roughly 30% of all COVID-19 infections developing into long-haul syndrome. Cytocom plans to conduct the trial under the existing IND and expects to begin enrolling patients by year-end 2021. CYTO-205 is designed to modulate immune system function by decreasing elevated inflammatory responses associated with viral infection.
About Cytocom
Cytocom Inc. is a clinical-stage biopharmaceutical company developing novel immunotherapies targeting autoimmune, neutropenia/anemia, emerging viruses and cancers based on a proprietary platform designed to rebalance the body’s immune system and restore homeostasis. The company also has one of the largest platforms of toll-like immune receptors (TLR4, TLR5 and TLR9) in the biopharmaceutical industry, addressing conditions such as radiation sickness and cancer treatment side effects. Cytocom is developing therapies designed to elicit directly within patients a robust and durable response of antigen-specific killer T-cells and antibodies, thereby activating essential immune defenses against autoimmune, inflammatory, infectious diseases, and cancers. Specifically, Cytocom has several clinical-stage development programs for Crohn’s disease, hematology, pancreatic cancer, and COVID-19 in addition to expansion to fibromyalgia and multiple sclerosis. To learn more about Cytocom Inc., please visit www.cytocom.com.
Forward Looking Statements:
This press release contains forward-looking statements that involve risks and uncertainties. All statements other than statements of current or historical fact contained in this press release, including statements regarding the expected clinical development timeline for its product candidates. The words "anticipate," "believe," "continue," "should," "estimate," "expect," "intend," "may," "plan," "project," "will," and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements on the current expectations about future events held by management. While we believe these expectations are reasonable, such forward-looking statements are inherently subject to risks and uncertainties, many of which are beyond our control. The company’s actual future results may differ materially from those discussed here for various reasons. The company discusses many of these risks under the heading "Risk Factors" in the proxy statement/prospectus filed with the SEC on June 10, 2021, as updated by the company’s other filings with the SEC. Factors that may cause such differences include, but are not limited to, the outcome of any legal proceedings that have been or may be instituted against the company related to the merger with Cleveland BioLabs; unexpected costs, charges or expenses resulting from the merger; our need for additional financing to meet our business objectives; our history of operating losses; our ability to successfully develop, obtain regulatory approval for, and commercialize our products in a timely manner; our plans to research, develop and commercialize our product candidates; our ability to attract collaborators with development, regulatory and commercialization expertise; our plans and expectations with respect to future clinical trials and commercial scale-up activities; our reliance on third-party manufacturers of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; the rate and degree of market acceptance of our product candidates; regulatory requirements and developments in the United States, the European Union and foreign countries; the performance of our third-party suppliers and manufacturers; the success of competing therapies that are or may become available; our ability to attract and retain key scientific or management personnel; our historical reliance on government funding for a significant portion of our operating costs and expenses; government contracting processes and requirements; the exercise of significant influence over our company by our largest individual stockholder; the impact of the novel coronavirus ("COVID-19") pandemic on our business, operations and clinical development; the geopolitical relationship between the United States and the Russian Federation as well as general business, legal, financial and other conditions within the Russian Federation; our ability to obtain and maintain intellectual property protection for our product candidates; our potential vulnerability to cybersecurity breaches; and other factors discussed in our SEC filings, including our Annual Report on Form 10-K for the year ended December 31, 2020 and the risk factors discussed under the heading “Risk Factors” in the proxy statement/prospectus the company filed in connection with the merger on June 10, 2021.
Given these uncertainties, you should not place undue reliance on these forward-looking statements. The forward-looking statements included in this press release are made only as of the date hereof. We do not undertake any obligation to update any such statements or to publicly announce the results of any revisions to any of such statements to reflect future events or developments.
Contacts:
Cytocom, Inc.
Nichol Ochsner
Senior V.P. Investor Relations and Corporate Communications
(732) 754-2545
nichol.ochsner@cytocom.com
Tiberend Strategic Advisors, Inc.
Maureen McEnroe, CFA (Investors)
(212) 375-2664
mmcenroe@tiberend.com
Johanna Bennett (Media)
(212) 375-2686
jbennett@tiberend.com
goforthebet
3 years ago
Cytocom Inc. Announces Completed Merger with Cleveland BioLabs
New company to operate as “Cytocom, Inc.” with its common stock traded on Nasdaq
FORT COLLINS, Colo., July 28, 2021 /PRNewswire/ -- Cytocom Inc. (“Cytocom” or “Company”), a leading biopharmaceutical company creating next-generation therapies that focus on immune homeostasis, today announced the completion of its merger with Cleveland BioLabs, Inc. The all-stock transaction was first announced on October 19, 2020.
Shares of the new Cytocom’s common stock will begin trading on Nasdaq under the ticker symbol “CBLI,” at the opening bell on Wednesday, July 28, 2021.
As previously reported, the newly combined company will operate as “Cytocom, Inc.” under the leadership of the existing Cytocom management team led by CEO Michael K. Handley. Mr. Handley now serves as the new company’s President and CEO.
“With the merger completed, we look forward to further advancing our late-stage clinical programs and expanding what we believe to be one of the largest toll-like receptor platforms in the industry,” said Michael K. Handley. “This merger, coupled with our acquisition of ImQuest Life Sciences and the listing of the new Cytocom common shares on Nasdaq, represents a transformative growth opportunity and fits firmly with our goal of becoming a recognized leader in immune-modulating therapies targeting cancer, ARS, inflammatory and autoimmune diseases, and viruses, including COVID-19. Looking forward, we anticipate achieving multiple commercial, regulatory and clinical milestones over the next 12 to 18 months that should enable us to showcase the power of our drug development platform and further generate shareholder value.”
McGuireWoods LLP represented Cleveland BioLabs and Troutman Pepper Hamilton Sanders LLP represented Cytocom in the merger.
About Cytocom
Cytocom, Inc. is a clinical-stage biopharmaceutical company developing novel immunotherapies targeting autoimmune, inflammatory, infectious diseases and cancers based on a proprietary platform designed to rebalance the body’s immune system and restore homeostasis. The company also has one of the largest platforms of toll-like immune receptors (TLR4, TLR5 and TLR9) in the biopharmaceutical industry, addressing conditions such as radiation sickness and cancer treatment side effects. Cytocom is developing therapies designed to elicit directly within patients a robust and durable response of antigen-specific killer T-cells and antibodies, thereby activating essential immune defenses against autoimmune, inflammatory, infectious diseases, and cancers. Specifically, Cytocom has several clinical-stage development programs for Crohn’s disease, fibromyalgia, multiple sclerosis and pancreatic cancer. To learn more about Cytocom, Inc., please visit www.cytocom.com.
Forward Looking Statements:
This press release contains forward-looking statements that involve risks and uncertainties. All statements other than statements of current or historical fact contained in this press release, including statements regarding the future financial position, business strategy, new products, budgets, liquidity, cash flows, projected costs, regulatory approvals, the impact of any laws or regulations applicable to the company, and plans and objectives of management for future operations, are forward-looking statements. The words "anticipate," "believe," "continue," "should," "estimate," "expect," "intend," "may," "plan," "project," "will," and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements on the current expectations about future events held by management of both companies. While we believe these expectations are reasonable, such forward-looking statements are inherently subject to risks and uncertainties, many of which are beyond the control of either company. The company’s actual future results may differ materially from those discussed here for various reasons. The company discusses many of these risks under the heading "Risk Factors" in the proxy statement/prospectus filed with the SEC, as updated by the company’s other filings with the SEC. Factors that may cause such differences include, but are not limited to, the outcome of any legal proceedings that have been or may be instituted against the company related to the merger agreement or the Merger; unexpected costs, charges or expenses resulting from the Merger; our need for additional financing to meet our business objectives; our history of operating losses; our ability to successfully develop, obtain regulatory approval for, and commercialize our products in a timely manner; our plans to research, develop and commercialize our product candidates; our ability to attract collaborators with development, regulatory and commercialization expertise; our plans and expectations with respect to future clinical trials and commercial scale-up activities; our reliance on third-party manufacturers of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; the rate and degree of market acceptance of our product candidates; regulatory requirements and developments in the United States, the European Union and foreign countries; the performance of our third-party suppliers and manufacturers; the success of competing therapies that are or may become available; our ability to attract and retain key scientific or management personnel; our reliance on government funding for a significant portion of our operating costs and expenses; government contracting processes and requirements; the exercise of significant influence over our company by our largest individual stockholder; the impact of the novel coronavirus ("COVID-19") pandemic on our business, operations and clinical development; the geopolitical relationship between the United States and the Russian Federation as well as general business, legal, financial and other conditions within the Russian Federation; our ability to obtain and maintain intellectual property protection for our product candidates; our potential vulnerability to cybersecurity breaches; and other factors discussed in our SEC filings, including our Annual Report on Form 10-K for the year ended December 31, 2020and the risk factors discussed under the heading “Risk Factors” in the proxy statement/prospectus the company filed in connection with the merger.
Given these uncertainties, you should not place undue reliance on these forward-looking statements. The forward-looking statements included in this press release are made only as of the date hereof. We do not undertake any obligation to update any such statements or to publicly announce the results of any revisions to any of such statements to reflect future events or developments.
goforthebet
3 years ago
I want to see some development as well, but I give them still a credit. I do think, that Mr. Phelps is not rising his very good reputation playing games. He needs more time to get things going. I still hope so..
Kevin J Phelps
https://www.globenewswire.com/en/news-release/2019/01/09/1683002/0/en/Immune-Therapeutics-welcomes-Kevin-Phelps-to-Board-of-Directors.html
Kevin Phelps is a finance and business development professional who has spent his career determining, satisfying and managing the operational needs of a wide range of companies. With greater than 25 years of broad, professional corporate experience, Mr. Phelps has held senior management positions, successfully raising capital for startup companies, managing financial organizations and developing new businesses through technology, strategic alliances and acquisition projects.
Mr. Phelps is a General Partner in Trillium Group, LLC, a Rochester, New York based venture capital firm and a Founder of Cashel Rock Advisors and FinanciaLink Strategic Alliances, two private wealth management firms specializing in strategies for corporations and high net-worth individuals.
His professional experience began as a CPA with Price Waterhouse (now PwC), where he consulted with over 20 companies with a principal focus on emerging growth opportunities. In 1987, he was recruited to head financial planning for Eastman Kodak’s BioProducts Division. He assisted in the spinoff of the business into an international joint venture and became the Chief Financial Officer of the new entity, Genencor International, Inc. In this role, he created and managed Genencor’s finance and treasury groups and established the company’s accounting and reporting practices. He raised in excess of $100 million in debt capital to fund Genencor’s operations and expansion. He also served as Vice President of New Business Development.
“We are very pleased to welcome Mr. Phelps to our Board of Directors. His extensive experience as a finance specialist, along with his deep knowledge of business development and operations, will assist the company in moving to the forefront of specialized pharmaceuticals,” stated Noreen Griffin, President and CEO of Immune Therapeutics, Inc.
“I am excited to join Immune Therapeutics’ Board of Directors and to contribute my experience in entrepreneurial ventures. Immune Therapeutics has great potential, and I intend to assist in maximizing this potential to bring unprecedented ROI for investors,” said Mr. Phelps.
“I look forward to working with Mr. Phelps. Mr. Phelps’s proven leadership in business and finance make him an excellent addition to IMUN’s Board,” stated Dr. Roscoe Moore, Chairman of Immune Therapeutics’ Board of Directors, member of the company’s Scientific Advisory Board, and Former United States Assistant Surgeon General.
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