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.

On August 16, 2021 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported updates on the IMerge Phase 3 trial in lower risk MDS and financial results for the second quarter ended June 30, 2021 (Press release, Geron, AUG 16, 2021, View Source [SID1234586636]). The Company will host a conference call today at 4:30 p.m. ET to discuss these updates and current events. As of June 30, 2021, the Company had $239.1 million in cash and marketable securities. These financial resources, combined with expected future non-dilutive funding under the current debt facility, are expected to fund operations through the end of the first quarter of 2023.

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"We are pleased with the achievement of 91% of the planned enrollment in IMerge Phase 3 and expect the trial to be fully enrolled in the fourth quarter of 2021. In addition, the expected timing for top-line results in IMerge Phase 3 has been accelerated by three months to the first quarter of 2023," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "By confirming the results from IMerge Phase 2 in the current IMerge Phase 3, including the depth, breadth and durability of transfusion independence, as well as the potential for disease modification, we expect imetelstat to be a highly differentiated product in lower risk MDS in comparison to drugs currently approved or in development today. We look forward to bringing this innovative and important drug to lower risk MDS patients, for whom there remain limited treatment options."

Phase 3 Clinical Development

Ongoing IMerge Phase 3 Clinical Trial in Lower Risk Myelodysplastic Syndromes (LR MDS)

As of August 12, 2021, the Company had achieved 91% of the planned enrollment in IMerge Phase 3. The Company expects the trial to be fully enrolled in the fourth quarter of 2021. In July 2021, a regularly scheduled Independent Data Monitoring Committee (IDMC) meeting was held, and the IDMC recommended that the trial continue without modification.

The significantly longer enrollment period caused by the COVID-19 pandemic has enabled a longer follow-up period than previously projected. As a result, the Company determined that the clinical cut-off date for the primary analysis could occur three months earlier than originally planned, which the Company expects will still provide a sufficiently mature data set to assess the benefit-risk profile of imetelstat. The Company has shortened the follow-up period after the last patient has been enrolled from 15 months to 12 months to enable the earlier clinical cut-off date for the primary analysis. With the revised 12-month follow-up period for the primary analysis, the Company now projects that top-line results from IMerge Phase 3 will be available in the first quarter of 2023.

For further information about IMerge Phase 3, including enrollment criteria, locations, and current status, please visit ClinicalTrials.gov/NCT02598661.

Ongoing IMpactMF Phase 3 Clinical Trial in Refractory Myelofibrosis (MF)

The Company plans to engage over 180 sites to participate in IMpactMF across North America, South America, Europe, Australia, and Asia, of which 55 sites are currently open for enrollment. In the second quarter of 2021, the first patient was dosed in IMpactMF. The Company continues to expect the interim analysis to occur in 2024 and the final analysis in 2025.

As the only MF Phase 3 trial with overall survival (OS) as the primary endpoint, the Company expects that success in this trial would provide unequivocal proof of clinical benefit for patients, as well as further evidence of disease-modifying activity with imetelstat treatment.

For further information about IMpactMF, including enrollment criteria, locations, and current status, please visit ClinicalTrials.gov/NCT04576156.

Investor Day

In November 2021, Geron plans to host a virtual event for investors and analysts at which management and key opinion leaders will discuss the following topics:

Imetelstat’s potential for disease modification in LR MDS and refractory MF;
Expected path to commercializing imetelstat;
Expansion of imetelstat development plans, including new studies in additional indications; and
An early discovery program in second generation telomerase inhibitors.
Recently Reported Data in June 2021

Poster Presentations at EHA (Free EHA Whitepaper)2021 Virtual Congress

In June 2021, two poster presentations of imetelstat Phase 2 data were made at the European Hematology Association (EHA) (Free EHA Whitepaper) Virtual Congress. These presentations, available on Geron’s website, further support imetelstat’s potentially differentiated approach to inhibiting telomerase activity to target the malignant stem and progenitor cells in the bone marrow responsible for the underlying hematologic myeloid malignancies.

The first poster presented new data and analyses of the clinical efficacy of imetelstat in molecularly defined subtypes based on cytogenetic and mutation profiles for patients in the IMerge Phase 2 clinical trial in lower risk MDS. As reported at previous EHA (Free EHA Whitepaper) meetings, meaningful and durable transfusion independence was observed in patients from IMerge Phase 2, including transfusion-free periods greater than one year, as well as substantial increases in hemoglobin. The new poster presentation reported clinical responses across different cytogenetic and molecularly defined categories, and these responses were independent of mutation status or number of mutations. These data support the unique telomerase inhibition mechanism of action of imetelstat and the potential to target the malignant stem and progenitor cells of the underlying disease. The Company is exploring these observations further in the ongoing IMerge Phase 3.

The second poster at EHA (Free EHA Whitepaper) presented new analyses of safety data from the IMbark Phase 2 trial in MF and the IMerge Phase 2 trial in lower risk MDS to understand the characteristics of hematologic and non-hematologic adverse events. These analyses highlighted that the imetelstat-related cytopenias are short, reversable and with limited clinical consequence when managed with the dose modification guidelines in the protocols.

Publication of IMbark Phase 2 Data in Journal of Clinical Oncology

Efficacy, safety and biomarker results from the IMbark Phase 2 clinical trial were published in the Journal of Clinical Oncology in a paper entitled "Randomized, Single-Blind, Multicenter Phase II Study of Two Doses of Imetelstat in Relapsed or Refractory Myelofibrosis." The publication, which is available online, highlights the clinical benefits observed in the study, including symptom response and OS, as well as evidence of disease-modifying activity from biomarker and bone marrow fibrosis assessments.

The trial design for IMpactMF is intended to confirm the IMbark Phase 2 results and to enable imetelstat to be a potential treatment option for MF patients who no longer respond to currently approved JAK inhibitor therapies. Currently, there is no approved drug for patients who fail or no longer respond to JAK inhibitor therapies, and median survival for such MF patients after discontinuation from ruxolitinib is only approximately 14 – 16 months, representing a significant unmet medical need.

Second Quarter and Year-to-Date 2021 Results

For the second quarter of 2021, the Company reported a net loss of $29.6 million, or $0.09 per share, compared to $15.8 million, or $0.06 per share, for the comparable 2020 period. Net loss for the first six months of 2021 was $57.4 million, or $0.18 per share, compared to $32.2 million, or $0.14 per share, for the comparable 2020 period.

Revenues for the three and six months ended June 30, 2021 were $107,000 and $244,000, respectively, compared to $43,000 and $95,000 for the comparable 2020 periods. Revenues in 2021 and 2020 primarily reflect estimated royalties from sales of cell-based research products from the Company’s divested stem cell assets. In connection with the divestiture of Geron’s human embryonic stem cell assets, including intellectual property and proprietary technology, to Lineage Cell Therapeutics, Inc. (formerly BioTime, Inc., which acquired Asterias Biotherapeutics, Inc.) in 2013, Geron is entitled to receive royalties on sales from certain research or commercial products utilizing Geron’s divested intellectual property.

Total operating expenses for the three and six months ended June 30, 2021 were $29.0 million and $57.6 million, respectively, compared to $16.8 million and $33.7 million for the comparable 2020 periods.

Research and development expenses for the three and six months ended June 30, 2021 were $21.9 million and $43.1 million, respectively, compared to $10.8 million and $21.6 million for the comparable 2020 periods. The increase in research and development expenses for the three and six months ended June 30, 2021, compared to the same periods in 2020, primarily reflects increased clinical development costs associated with conducting two Phase 3 clinical trials, higher imetelstat manufacturing costs for producing validation batches at contract manufacturers to enable future production of imetelstat for clinical and commercial purposes and higher personnel-related costs for additional headcount.

General and administrative expenses for the three and six months ended June 30, 2021 were $7.1 million and $14.5 million, respectively, compared to $6.0 million and $12.1 million for the comparable 2020 periods. The increase in general and administrative expenses for the three and six months ended June 30, 2021, compared to the same periods in 2020, primarily reflects new costs in connection with pre-commercial activities, including modernizing the internal infrastructure to support a commercial launch, and higher legal costs.

Interest income for the three and six months ended June 30, 2021 was $136,000 and $309,000, respectively, compared to $475,000 and $1.2 million for the comparable 2020 periods. The decrease in interest income for the three and six months ended June 30, 2021, compared to the same periods in 2020, primarily reflects lower yields on the Company’s marketable securities portfolio.

Interest expense for the three and six months ended June 30, 2021 was $804,000 and $1.5 million, respectively and reflects the Company’s debt facility secured in September 2020 for up to $75 million. In June 2021, the Company completed a drawdown of $10.0 million in accordance with the loan agreement. Currently, a total of $35.0 million has been drawn down under the facility.

Financial Resources

Previously, the Company provided guidance that its financial resources were sufficient to fund its operations through the end of 2022. As of June 30, 2021, the Company had $239.1 million in cash and marketable securities. These financial resources, combined with expected future non-dilutive funding under the current debt facility, are now expected to fund operations through the end of the first quarter of 2023.

As of June 30, 2021, the Company had 68 employees. The Company plans to grow to a total of approximately 80 to 85 employees by year-end 2021, of which the majority will be development and manufacturing personnel.

Conference Call

Geron will host a conference call at 4:30 p.m. ET on Monday, August 16, 2021 to provide an update on the ongoing imetelstat Phase 3 clinical trials, IMerge in MDS and IMpactMF in MF, as well as discuss second quarter financial results.

To view the Company’s slide presentation and listen to the conference call live via webcast, visit the Company’s website at www.geron.com/investors/events at the time of the conference call. An archive of the webcast will also be available on the Company’s website for 30 days.

Participants may access the conference call live via telephone by pre-registering online using the following link, View Source Upon registration, a phone number, Direct Event Passcode and unique Registrant ID will be sent via email. This information will be needed in order to enter the conference call. Participants are advised to pre-register at least 10 minutes prior to joining the call.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in hematologic myeloid malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment.

About IMerge Phase 3

IMerge Phase 3 is a double-blind, randomized, placebo-controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 170 transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS), also referred to as lower risk MDS, who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). The primary endpoint is the rate of red blood cell (RBC) transfusion independence (TI) for any consecutive period of eight weeks or longer, or 8-week RBC-TI rate. Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks, or 24-week RBC-TI rate, and the rate of hematologic improvement-erythroid (HI-E), defined as a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden.

IMerge Phase 3 is currently enrolling patients. For further information about IMerge Phase 3, including enrollment criteria, locations and current status, visit ClinicalTrials.gov/NCT02598661.

About IMpactMF

IMpactMF is an open label, randomized, controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 320 patients with Intermediate-2 or High-risk myelofibrosis who are refractory to prior treatment with a JAK inhibitor, also referred to as refractory MF. Patients will be randomized to receive either imetelstat or best available therapy. The primary endpoint is overall survival (OS). Key secondary endpoints include symptom response, spleen response, progression free survival, complete response, partial response, clinical improvement, duration of response, safety, pharmacokinetics, and patient reported outcomes.

IMpactMF is currently enrolling patients. For further information about IMpactMF, including enrollment criteria, locations and current status, visit ClinicalTrials.gov/NCT04576156.

On August 16, 2021 McKesson Corporation (NYSE:MCK) reported that the Company will host an Investor Day on December 8, 2021 in New York City (Press release, McKesson, AUG 16, 2021, View Source [SID1234586652]).

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A live audio webcast and presentation slides will be available on McKesson’s Investor Relations website at View Source Further details will be provided at a later date.

On August 16, 2021 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported that appointed Patrick Soon-Shiong, M.D., to the newly created role of Global Chief Scientific and Medical Officer, effective as of August 11, 2021 (Press release, ImmunityBio, AUG 16, 2021, View Source [SID1234586620]). In this additional role, Dr. Soon-Shiong will oversee the company’s global research and development programs and pipeline investments in support of its ambitious growth plans, which include bringing advanced technology to a broad global marketplace.

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"As both the founder of ImmunityBio and a visionary biotech innovator, Patrick’s expertise has always been an invaluable asset to the organization," said Richard Adcock, President and CEO of ImmunityBio. "We are grateful for his leadership and commitment to drive the scientific agenda of our business forward. His unwavering focus on advancing potential breakthrough therapies for cancer and infectious disease has already improved the quality of life for thousands of patients."

"My entire life’s work has been to discover and bring to market better treatments for cancer and other difficult-to-treat diseases, and thanks to incredible innovations over the last few years, we’re closer than ever to that goal," said Dr. Soon-Shiong. "Our growing knowledge of the immune system will serve as the foundation for the research priorities we’re setting at ImmunityBio. These priorities will guide our ongoing quest for life-saving and life-extending therapeutics, including a commitment to ensure they are available to people in underserved nations in Africa and elsewhere. That’s my goal and the goal of everyone on our highly experienced research, clinical development, and medical teams."

On August 16, 2021 Clovis Oncology, Inc. (NASDAQ:CLVS) reported that it has filed a prospectus supplement with the U.S. Securities and Exchange Commission ("SEC") to renew its previously established ATM facility under which it may offer and sell, from time to time, additional shares of its common stock having an aggregate offering price of up to $125,000,000 through an "at-the-market" equity offering program (the "ATM Program") (Press release, Clovis Oncology, AUG 16, 2021, View Source [SID1234586637]). The timing and amount of any sales will be determined by a variety of factors considered by Clovis Oncology.

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Shares of Clovis Oncology common stock will be offered through J.P. Morgan Securities LLC ("JPM") and BofA Securities, Inc. ("BofA Securities"), who are serving as the distribution agents. JPM and BofA Securities may sell the shares of our common stock by any method deemed to be an "at-the-market offering" defined by Rule 415(a)(4) of the Securities Act of 1933, as amended, including without limitation, sales in ordinary brokers’ transactions, including directly on the Nasdaq Global Select Market or into any other existing trading market for the shares, or to or through a market maker, in block transactions or by any other method permitted by law, including privately negotiated transactions and to JPM and BofA Securities as principals for their own account. Sales may be made at market prices prevailing at the time of a sale or at prices related to prevailing market prices or at negotiated prices. As a result, sales prices may vary.

Clovis Oncology intends to use the net proceeds from any sales of its common stock under the ATM Program for general corporate purposes, including funding of its development programs, sales and marketing expenses associated with Rubraca (rucaparib), repayment, repurchase or refinance of its debt obligations, payment of milestones pursuant to its license agreements, general and administrative expenses, acquisition or licensing of additional product candidates or businesses and working capital.

Clovis Oncology’s prospectus supplement filed today with the SEC supplements information contained in the accompanying prospectus contained in the shelf registration statement on Form S-3 (File No. 333-253485), as amended for the offering. Prospective investors should read the prospectus in that registration statement, the prospectus supplement and all other documents that Clovis Oncology has filed with the SEC for more complete information about Clovis Oncology, including information pertaining to the ATM Program and the risks associated with investing in Clovis Oncology. Copies of the prospectus supplement and related prospectus may be obtained from J. P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email to [email protected], or from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte NC 28255-0001, Attn: Prospectus Department or by email to [email protected]. You may also obtain these documents free of charge when they are available by visiting EDGAR on the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.