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Cytocom, Inc. Reports Second Quarter 2021 Financial Results

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.

Cogent Biosciences Provides Corporate Updates and Reports Second Quarter 2021 Financial Results

On August 16, 2021 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported financial results for the second quarter ended June 30, 2021 and provided corporate updates (Press release, Cogent Biosciences, AUG 16, 2021, View Source [SID1234586605]).

"People fighting advanced systemic mastocytosis live every day in need of additional treatment options. We initiated the Phase 2 APEX clinical study for our lead program bezuclastinib, designed to specifically target the underlying genetic cause of advanced systemic mastocytosis with the goal of providing new therapeutic options for patients," said Andrew Robbins, President and CEO of Cogent Biosciences. "In addition, we look forward to advancing bezuclastinib into two new clinical studies by the end of 2021, including the SUMMIT study for patients with non-advanced systemic mastocytosis, while actively progressing novel discovery programs with the recently formed Cogent Research Team."

Recent Program and Corporate Highlights

APEX Study in AdvSM Patients Initiated
Cogent initiated APEX, a Phase 2 clinical study of bezuclastinib in patients with AdvSM. APEX is an open-label, global, multicenter study that will evaluate the safety, efficacy, pharmacokinetic, and pharmacodynamic profiles of bezuclastinib. Learn more about the APEX study at www.cogentclinicaltrials.com
Cogent expects to report preliminary clinical data from the APEX study in the first half of 2022, including levels of serum tryptase, a validated biomarker of mast cell activity.
SUMMIT Study of bezuclastinib in NonAdvSM Patients on track to start 2H 2021
Following recent positive interactions with FDA, Cogent is on track to initiate SUMMIT, a randomized, double-blind placebo-controlled Phase 2 clinical study of bezuclastinib in patients with NonAdvSM.
FDA Granted Orphan Drug Designation for bezuclastinib in GIST (Gastrointestinal Stromal Tumors)
FDA granted orphan drug designation for bezuclastinib for the treatment of GIST with an estimated 4,000 to 6,000 GIST cases diagnosed annually in the United States.
Cogent remains on track to initiate a new study of bezuclastinib and sunitinib in GIST patients during 2H 2021.
Cogent Research Team continues to evolve efforts in pioneering best-in-class, small molecule therapeutics
Based in Boulder, Colorado, the Cogent Research Team continues to focus on developing best-in-class, small molecule therapeutics to expand Cogent’s pipeline and deliver novel precision therapies for patients living with unmet medical needs.
Announced long-term lease on ~40,000 sq. ft. facility which will serve as laboratory and office space headquarters for Cogent Research Team.
Formed the Cogent Scientific Advisory Board
Comprised of world-class experts involved in the discovery and development of novel therapeutics for patients with genetically-driven diseases, this group has been brought together to provide external perspective for the Cogent Research Team as it develops a robust portfolio of novel, small molecule discovery programs designed to address significant patient unmet needs.
Dr. Ryan Corcoran, MD, PhD – Director of the Gastrointestinal Cancer Center Program and Scientific Director, Termeer Center for Targeted Therapy at the Massachusetts General Hospital Cancer Center and Associate Professor of Medicine at Harvard Medical School
Dr. Michael Vasconcelles, MD – Chief Medical Officer of Flatiron Health, a healthcare technology and services company focused on accelerating cancer research and improving patient care
Dr. Srdan Verstovsek, MD, PhD – United Energy Resources, Inc. Professor of Medicine and a hematologist-oncologist at the MD Anderson Cancer Center, Houston, Texas, USA
Dr. Kwok-Kin Wong, MD, PhD – Director, Division of Hematology and Medical Oncology, Anne Murnick Cogan and David H. Cogan Professor of Oncology, Department of Medicine, Laura and Isaac Perlmutter Cancer Center, NYU Langone Health
Second Quarter 2021 Summarized Financial Results

R&D Expenses: Research and development expenses were $12.4 million for the second quarter of 2021 as compared to $5.1 million for the second quarter of 2020. R&D expenses include non-cash stock compensation expense of $1.0 million for the second quarter of 2021 compared to $0.5 million for the second quarter of 2020.
G&A Expenses: General and administrative expenses were $4.9 million for the second quarter of 2021 as compared to $2.8 million for the second quarter of 2020. G&A expenses include non-cash stock compensation expense of $1.6 million for the second quarter of 2021 compared to $0.4 million for the second quarter of 2020.
Net Loss: Net loss was $16.5 million for the second quarter of 2021 as compared to a net loss of $7.4 million for the second quarter of 2020. During the second quarter of 2021, the company spent $12.6 million of its cash and cash equivalents.
Cash and Cash Equivalents: As of June 30, 2021, Cogent had cash and cash equivalents of $218.1 million. The company believes that its cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into 2024.

Exact Sciences receives regulatory approval for the Oncotype DX Breast Recurrence Score® Program in Japan

On August 16, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved the Oncotype DX Breast Recurrence Score Program (Press release, Exact Sciences, AUG 16, 2021, View Source [SID1234586599]). The test helps guide chemotherapy treatment recommendations and provides risk of distant recurrence in patients with hormone receptor-positive, HER2-negative early-stage breast cancer with up to three positive lymph nodes. MHLW approval is a critical step in making Oncotype DX accessible to breast cancer patients in Japan.

Breast cancer is the most common cancer in Japanese women, and more than 90,000 new breast cancer cases were diagnosed in Japan in 2020.i The Oncotype DX Breast Recurrence Score Program approved in Japan combines the Oncotype DX Breast Recurrence Score test and software developed for the Japanese market. Exact Sciences plans to pursue coverage under Japan’s universal healthcare insurance system and launch the test through its Japanese affiliate, Exact Sciences K.K.

"MHLW’s approval of Oncotype DX is great news for breast cancer patients in Japan and reflects the powerful evidence backing the Oncotype DX test," said Kevin Conroy, chairman and CEO. "Our international team is enabling new areas of growth for our current advanced cancer tests and will accelerate access to future innovative tests for patients around the world."

The Oncotype DX test provides information allowing doctors and patients to personalize treatment plans with greater confidence.ii While chemotherapy is routinely offered, research shows that only a minority of patients with early-stage breast cancer will actually benefit.iii Oncotype DX is the only test validated to determine which patients will benefit from chemotherapy and provides critical information beyond traditional prognostic factors.iv-viii The test is supported by prospective outcomes data from the TAILORxvii and RxPONDERviii studies, which show that most patients with either node-negative or node-positive disease can be spared chemotherapy when decisions are guided by Oncotype DX.

About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention, and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Exact Sciences. The Oncotype MAP Pan-Cancer Tissue test is a rapid, comprehensive tumor profiling panel that aids therapy selection for patients with advanced, metastatic, refractory, or recurrent cancer. With more than 1 million patients tested in more than 90 countries, the Oncotype tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.

Kumquat Biosciences and Eli Lilly have reached a partnership to jointly develop tumor immune small molecule drugs

On August 16, 2021 Recently, Loxo Oncology, a research and development group of Eli Lilly, and Kumquat Biosciences (Kumquat) reported that the two parties have reached an exclusive collaboration agreement to jointly discover, develop and commercialize a series of innovative small molecule drug candidates that cause tumor-specific immune responses (Press release, Shanghai Medicilon, AUG 16, 2021, View Source [SID1234586598]).

As a collaborative partner of Kumquat, Shanghai Medicilon Inc. (Medicilon) congratulates the Kumquat Biosciences on the new progress of small molecule immuno-oncology (IO) platform.

Kumquat Biosciences and Eli Lilly have reached a partnership to jointly develop tumor immune small molecule drugs
According to the agreement, Kumquat will use its small molecule immuno-oncology (IO) platform to discover the innovative clinical drug candidates, from which Eli Lilly could select a certain number of drug candidates for further development and commercialization of global market except Greater China Region. Kumquat reserves the right to develop and commercialize each drug candidate selected by Eli Lilly in the Greater China region, however Eli Lilly has the right to participate in the joint commercialization of these drugs in the Greater China region. In addition, Kumquat could choose to jointly develop and commercialize certain drug candidates selected by Eli Lilly in the United States.

The collaboration between the two parties is the starting point after Kumquat has focused on small-molecule tumor immunotherapy. As a collaborative partner, Medicilon has the honor to witness the growth of Kumquat. Currently, Medicilon has over 50 researchers providing chemical FTE services for Kumquat. Medicilon is continuing to empower Kumquat with the flexibly adjustable solutions, controllable project progress, and customizable synthesis lines.

Guided by customer needs with the mission of innovative drug research, the FTE team of Medicilon is committed to providing high-quality emerging compounds for new drug research and development organizations. The pharmaceutical service includes medicinal chemistry, compound library design and synthesis, synthetic chemistry and synthetic process research and development. This collaboration model is cost effective and could be flexibly adjusted based on customer and project needs.

"Congratulations to Kumquat and Eli Lilly for reaching collaboration," Medicilon Founder & CEO Dr. Chunlin Chen said, "Medicilon wishes Kumquat shine in the field of tumor immunotherapy, achieve more innovative research and development results, and bring hope to the tumor patients around the world."

ANTICANCER AGENT “TAZVERIK® TABLETS 200mg” (TAZEMETOSTAT HYDROBROMIDE) LAUNCHED IN JAPAN FOR EZH2 GENE MUTATION-POSITIVE FOLLICULAR LYMPHOMA

On August 16, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that it has obtained manufacturing and marketing approval for the EZH2 inhibitor "Tazverik Tablets 200 mg" (tazemetostat hydrobromide) in Japan with the indication of relapsed or refractory EZH2 gene mutation-positive follicular lymphoma (only when standard treatment is not applicable) (Press release, Eisai, AUG 16, 2021, View Source [SID1234586585]).

This approval is based on the results of a multicenter, open-label, single-arm clinical phase II trial (Study 206)1 in Japan conducted by Eisai and other studies2 conducted by Epizyme, Inc. (Headquarters: Massachusetts, United States) outside Japan. Study 206 enrolled patients with EZH2 gene mutation-positive, primarily follicular lymphoma, who had relapsed or were refractory. The primary endpoint of this study was objective response rate (ORR), and secondary endpoints included safety. This study achieved the primary endpoint target and exceeded a prespecified tumor response threshold with statistical significance: ORR in patients with EZH2 mutation-positive relapsed or refractory follicular lymphoma (n=17) was 76.5% (90% confidence interval (CI): 53.9-91.5) as measured by independent review. Treatment-emergent adverse events (incidence of 25% or more) observed in this study were dysgeusia (52.9%), nasopharyngitis (35.3%), lymphopenia (29.4%) and blood creatine phosphokinase increased (29.4%). Eisai will conduct a post-marketing special use results survey (all-case surveillance) in all patients who are administered "Tazverik" until a pre-determined number of patients has been reached in accordance with an approval condition imposed by the MHLW.

Created by utilizing Epizyme’s proprietary product platform, "Tazverik" is a first-in-class small molecule inhibitor of the epigenetic enzyme EZH2. It is one of the histone methyltransferases in the epigenetics-related protein group, and is thought to regulate the expression of cancer-related genes and suppress the growth of cancer cells by specifically targeting EZH2, which contributes to the cancer growth process.3 Eisai is responsible for the development and commercialization of this agent in Japan, while Epizyme, Inc. is responsible for all regions outside of Japan. In the United States, "Tazverik" received accelerated approval for the indication of epithelioid sarcoma in January 2020, and follicular lymphoma in June 2020 (Notes to editors 1).

Follicular lymphoma is a low-grade B-cell lymphoma that accounts for 10-20% of non-Hodgkin’s lymphomas. Follicular lymphoma is generally indolent and sensitive to chemotherapy. However, development of a new treatment strategy is required for follicular lymphoma which still remains difficult to cure, as recurrence often occurs repeatedly. 7-27% of follicular lymphomas are reported to have gain-of-function mutations in the EZH2 gene,4,5 and it is estimated that there are approximately 600 to 2,400 patients with follicular lymphoma with EZH2 gene mutations in Japan. A companion diagnostic test for EZH2 gene mutations, "cobas EZH2 Mutation Test" by Roche Diagnostics K.K. (Headquarters: Tokyo) was approved in May 2021.
　

Eisai aims to make continuous efforts to meet the diversified needs of and increase the benefits provided to patients with cancer, their families, and healthcare professionals, by delivering "Tazverik" as a new treatment option for EZH2 gene mutation-positive follicular lymphoma.　

1. About "Tazverik Tablets 200 mg" (tazemetostat hydrobromide, Development Code: E7438, Epizyme, Inc.’s Development Code: EPZ-6438)

"Tazverik" is a first-in-class, oral small molecule inhibitor that targets EZH2. Eisai and Epizyme, Inc. have conducted joint research and development with utilizing Epizyme, Inc.’s proprietary product platform, based on the alliance agreement concluded in March 2011 targeting EZH2 for research, development, and sales. This agent selectively inhibits EZH2 in a competitive matter with S-adenosylmethionine (a methyl group donor) to suppress methylation of H3K27. Due to the alteration in the alliance agreement between the two companies in March 2015, Eisai is responsible for development and commercialization of this agent in Japan, while Epizyme, Inc. is responsible for all regions outside Japan.

At the Kawashima Industrial Park located in Gifu Prefecture, Japan, the production site for this agent in Japan, Eisai has successfully developed the innovative pharmaceutical manufacturing technology so-called "Continuous Manufacturing", and has applied it to production. Continuous Manufacturing contributes to quality improvement and stable supply of pharmaceutical products by integrating manufacturing automation and real-time quality monitoring technology. In addition, Continuous Manufacturing is a technology that is attracting attention as a new pharmaceutical manufacturing method that can achieve high production efficiency with space saving and energy saving, and has a low environmental load. Eisai was one of the first to adopt Continuous Manufacturing system (CTS-MiGRA) and applied this technology to the production of this agent.

The accelerated approval was granted for this agent in January 2020 in the United States with the indication of "adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection". Also, in June of the same year, the accelerated approval was granted for this agent with the indication of "adult relapsed / refractory follicular lymphoma who had at least 2 regimens of prior treatment and whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test", and of "adult relapsed / refractory follicular lymphoma for which there are no satisfactory alternative treatment options".

2. About epigenetics

Epigenetics is a branch of science that studies the mechanism for the acquired activation/inactivation of gene function and seeks to determine how gene function is inherited through cell division, irrespective of DNA base sequence alteration. Examples of modification that lead to the regulation of gene expression include methylation of DNA and modifications of histone (methylation, acetylation, phosphorylation, etc.).

3. About EZH2

EZH2 is one of the histone methyltransferases within a larger class of epigenetics-related proteins, and specifically catalyzes the methylation of histone H3 at lysine 27 (H3K27), thus controlling expression of various genes. It is indicated that an increase in methylation of H3K27 caused by EZH2 gain-of-function mutation, overexpression, or the dysfunction of EZH2 suppressive factors plays an important role in carcinogenesis.

1 Shinya Rai, et al. Phase 2 Study of Tazemetostat in Japanese patients with Relapsed or Refractory EZH2 mutation-positive B-cell Non-Hodgkin’s Lymphoma. AACR (Free AACR Whitepaper) Meet. 2021, CT176.

2 Franck Morschhauser, et al. Tazemetostat for patients with relapsed or refractory follicular lymphoma: an open-label, single-arm, multicentre, phase 2 trial. The Lancet Oncology. 2020 Nov; 21(11):1433-1442.

3 Sarah K. Knutson, Satoshi Kawano, Yukinori Minoshima, et al. Selective Inhibition of EZH2 by EPZ-6438 Leads to Potent Antitumor Activity in EZH2-Mutant Non-Hodgkin Lymphoma. Molecular Cancer Therapeutics. 2014 Apr; 13(4):842–854.

4 Csaba Bödör, et al. EZH2 mutations are frequent and represent an early event in follicular lymphoma. Blood, 2013 Oct; 122(18), 3165-3168.

5 Ryan D. Morin, et al. Somatic mutation of EZH2 (Y641) in Follicular and Diffuse Large B-cell Lymphomas of Germinal Center Origin. Nat Genet. 2010 February; 42(2): 181–185.