On November 15, 2021 Zenith Capital Corp. ("Zenith" or the "Company") reported that Zenith Epigenetics Ltd. ("Zenith Epigenetics"), a wholly-owned subsidiary of Zenith Capital, has entered into a licensing agreement with Newsoara Biopharma Co., Ltd. ("Newsoara") for Zenith Epigenetics’ lead compound, ZEN-3694, in Asia excluding Middle East and North Africa ("MENA"), India, and ten Eurasian countries (the "Territories") (Press release, Zenith Epigenetics, NOV 15, 2021, View Source [SID1234595610]). Under the terms of the agreement, Newsoara will have the rights to develop, market, and distribute ZEN-3694 for all indications in the Territories. Zenith will receive an upfront payment of US$3.5 million, sales-based milestones and single digit royalties.

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Concurrent with the execution of the license agreement, Newsoara has entered into a subscription agreement to subscribe for 1.5 million units at a price of US$1.00 per unit, and Newsoara also agreed to subscribe for an additional 10 million units of Zenith by way of completing ZEN-3694 development programs with a budget of $10 million over the next 15 months. Each unit ("Unit") shall be comprised of one common share and one-half of a common share purchase warrant. Each whole warrant shall be exercisable into one common share at US$1.00 for a period of two years from the date of the subscription agreement.

"We are very pleased to further expand our partnership with Newsoara to introduce the therapeutic potential of ZEN-3694 to additional Asian markets," stated Donald McCaffrey, President and CEO of Zenith. "ZEN-3694 is a leading and differentiated BET inhibitor now having shown clinical proof of concept in two solid tumor indications with significant unmet need, metastatic castration-resistant prostate cancer and metastatic triple negative breast cancer. This additional financing will support advancing these programs towards registration enabling studies for these indications in collaboration with our partner Newsoara."

On November 15, 2021 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported financial results for the third quarter ended September 30, 2021 (Press release, Ideaya Biosciences, NOV 15, 2021, View Source [SID1234595609]).

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"Early clinical data on our potential best-in-class Phase 1 MAT2A inhibitor, IDE397, in MTAP-deletion patients shows preliminary signals of clinical activity, including pharmacodynamic modulation and tumor shrinkage in multiple patients. In addition, we selected a lead compound as a potential first-in-class development candidate for IND-enabling studies for our PARG synthetic lethality program and made progress towards our goal to select a potential first-in-class development candidate with GlaxoSmithKline for the Pol Theta Helicase program this year. We are targeting to provide an update in the fourth quarter of 2021 for the Phase 2 clinical trial evaluating darovasertib and crizotinib combination in metastatic uveal melanoma, including clinical efficacy and guidance on timing for a potential registration enabling trial," said Yujiro S. Hata, Chief Executive Officer and President of IDEAYA Biosciences.

Program Updates
Key highlights for IDEAYA’s pipeline programs include:

IDE397 (MAT2A)
IDEAYA is evaluating IDE397, a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2a (MAT2A), in patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion, a patient population estimated to represent approximately 15% of solid tumors. IDEAYA is leading early clinical development of IDE397. Subject to exercise of its option, GlaxoSmithKline (GSK) will lead later stage global clinical development. Highlights:

Actively enrolling patients into Cohort 5 of the Phase 1 clinical trial IDE397-001 (NCT04794699)
Patients are being identified by next generation sequencing (NGS) or by MTAP immunohistochemistry (IHC) assay with confirmatory NGS
Evaluating IDE397 in patients with MTAP deletion across multiple solid tumor types, including non-small cell lung cancer, pancreatic cancer, thymic cancer, adenoid cystic carcinoma and gastroesophageal cancer
IDE397 has been generally well tolerated, with observed drug-related adverse events as of November 5, 2021 of only grade 1/2 drug-related adverse events; there were no reported drug-related serious adverse events and no reported myelosuppression or liver toxicity; IDE397 has yet to reach its Maximum Tolerated Dose
Observed preliminary signals of clinical activity in MTAP-deletion patients in early dose escalation cohorts, including plasma s-adenosyl methionine (SAM) pharmacodynamic (PD) modulation in IDE397 dose escalation Cohorts 1 through 3, and tumor shrinkage in multiple patients in early dose escalation Cohorts 2 and 3
Subject to initiation of an expansion cohort or establishing a maximum tolerated dose, or MTD, targeting submission of IDE397 option data package to GSK in the first half of 2022, which would trigger an evaluation period for GSK to make an opt-in decision; subject to GSK election to opt-in and HSR clearance, the company is entitled to receive a $50 million opt-in payment from GSK
Targeting a clinical data update on IDE397, including plasma SAM and tumor SAM and SDMA pharmacodynamic data and tolerability, upon delivery of the option data package to GSK in the first half of 2022
Targeting clinical protocol amendment submission to the FDA by year end 2021 to support monotherapy cohort expansions in the first half of 2022 in NSCLC, esophagastric cancer, as well as squamous and non-squamous basket cohorts, and to support potential taxane combinations in NSCLC, esophagastric and/or pancreatic cancer
Subject to satisfactory progression of the dose escalation portion of the Phase 1 clinical trial, planning to enroll MTAP deletion patients into monotherapy expansion cohorts in the first half of 2022 with an aggregate of 150 or more patients across expansion cohorts
Observed preclinical in vivo efficacy of IDE397 in combination with a taxane, showing enhanced TGI in pancreatic cancer PDX models; evaluating additional potential IDE397 combination strategies with therapeutics targeting DDR, selected co-alteration targets, and selected MTAP-SL targets
PARG
IDEAYA is advancing preclinical research for an inhibitor of poly (ADP-ribose) glycohydrolase (PARG) in patients having tumors with a defined biomarker based on genetic mutations and/or molecular signature. PARG is a novel target in the same clinically validated biological pathway as poly (ADP-ribose) polymerase (PARP). IDEAYA owns or controls all commercial rights in its PARG program. Highlights:

Identified a novel and proprietary HRD biomarker to guide patient selection, with validation in vitro and in vivo in CDX models across multiple solid tumor indications
Demonstrated PARGi dose-dependent in vivo efficacy as monotherapy with tumor regression or stasis in ovarian, gastric and breast cancer CDX models
Observed in vivo efficacy with enhanced TGI or tumor regressions relative to niraparib, a PARPi, in multiple CDX models, including in a niraparib-resistant CDX model
Showed tumor regressions in multiple breast cancer PDX models with defined genetic and subtyping profiles, including in niraparib resistant PDX models
Showed pharmacological inhibition of PARG in a panel of homologous recombination deficient cell lines and in CDX and PDX models; study data reported at AACR (Free AACR Whitepaper) 2021
Selected a potential development candidate PARG inhibitor and initiating further toxicology studies; planning to initiate further preclinical development studies, including IND-enabling studies of the selected lead compound
Pol Theta
IDEAYA’s DNA Polymerase Theta, (Pol Theta) program targets tumors with BRCA or other homologous recombination deficiency, or HRD, mutations. IDEAYA and GSK are collaborating on ongoing preclinical research, including small molecules and protein degraders, and GSK will lead clinical development for the Pol Theta program. Highlights:

Demonstrated in vivo efficacy with tumor regression in BRCA2 -/- xenograft model with IDEAYA Pol Theta Helicase inhibitor in combination with niraparib, a GSK PARP inhibitor; and
Subject to further preclinical studies, IDEAYA is targeting selection of a Pol Theta Helicase inhibitor development candidate in December 2021
Potential for up to $20 million in aggregate milestone payments from GlaxoSmithKline for advancing a Pol Theta Helicase inhibitor from preclinical to early Phase 1 clinical
Werner Helicase
IDEAYA is advancing preclinical research for an inhibitor targeting Werner Helicase for tumors with high microsatellite instability (MSI). IDEAYA and GSK are collaborating on ongoing preclinical research, and GSK will lead clinical development for the Werner Helicase program. Highlights:

Observed dose-dependent cellular viability effect and dose-dependent cellular PD response in multiple endogenous MSI high cell lines
Demonstrated efficacy and PD response in relevant MSI high in vivo models
Potential for up to $20 million in aggregate milestone payments from GlaxoSmithKline for advancing a Werner Helicase inhibitor from preclinical to early Phase 1 clinical
Other Synthetic Lethality Pipeline Programs
IDEAYA is advancing additional preclinical research programs to identify small molecule inhibitors for an MTAP-synthetic lethality target, as well as for multiple potential first-in-class synthetic lethality programs for patients with solid tumors characterized by proprietary biomarkers or gene signatures.

Darovasertib (IDE196)
IDEAYA continues to execute on its clinical trial strategy to evaluate darovasertib (IDE196), a potent and selective PKC inhibitor.

IDEAYA is evaluating darovasertib in metastatic uveal melanoma (MUM) as monotherapy and in combination therapies, including combinations of darovasertib / binimetinib and independently, darovasertib / crizotinib. The company is continuing to enroll MUM patients into each of the combination arms of the Phase 1/2 clinical trial.

IDEAYA is targeting a clinical data update for darovasertib and crizotinib combination in the fourth quarter of 2021, including adverse event profile and clinical efficacy. IDEAYA is planning to seek FDA regulatory guidance for potential registration-enabling trial design to evaluate darovasertib and crizotinib combination in MUM in the first half of 2022.

The company is continuing to evaluate darovasertib in patients having non-MUM tumors harboring GNAQ or GNA11 activating mutations, with a focus in skin and mucosal melanoma.

Darovasertib Monotherapy
IDEAYA has completed enrollment into its ongoing Phase 1/2 clinical trial evaluating darovasertib as monotherapy in MUM patients.

IDEAYA is coordinating with St. Vincent’s Hospital Sydney Limited to initiate an Investigator Sponsored Trial, or IST, to evaluate IDE196 as monotherapy in a neo-adjuvant / adjuvant setting in (non-metastatic) uveal melanoma (UM) patients. Data from this clinical trial may offer proof of concept on our hypothesis that earlier treatment of UM patients with IDE196, prior to tumor metastasis, may lead to improved patient outcomes.

Darovasertib / Binimetinib Combination Therapy
IDEAYA is continuing patient enrollment into the darovasertib / binimetinib combination arm of the Phase 1/2 clinical trial under the clinical trial collaboration and supply agreement with Pfizer. Highlights:

As of November 5, 2021, the company has enrolled 32 MUM patients into the darovasertib/binimetinib combination arm, and is continuing patient enrollment in the dose expansion cohort of this combination arm
Darovasertib / Crizotinib Combination Therapy
IDEAYA is continuing patient enrollment into the darovasertib / crizotinib combination arm of the Phase 1/2 clinical trial under the clinical trial collaboration and supply agreement with Pfizer. Highlights:

As of November 5, 2021, the company has enrolled 28 MUM patients into the darovasertib/crizotinib combination arm, and is continuing patient enrollment in the dose expansion cohort of this combination arm
Amended Pfizer clinical trial collaboration and supply agreement to enable expansion for 40 additional patients on darovasertib / crizotinib combination
Observed preclinical synergies between darovasertib and crizotinib in relevant cellular models under conditions simulating a tumor microenvironment in the liver, the site of approximately 90% of uveal melanoma metastases; study data reported at AACR (Free AACR Whitepaper) 2021
Correlated cMET expression and activation to observed clinical response based on a retrospective analysis of human clinical biopsies from the Novartis darovasertib Phase 1 clinical trial, supporting cMET expression / activation as potential combination agent
Darovasertib – Other Potential Indications
IDEAYA is evaluating the potential for darovasertib in GNAQ mutation-mediated rare diseases, including Sturge-Weber Syndrome (SWS) and Port Wine Stains (PWS), neurocutaneous disorders characterized by capillary malformations and associated with mutations in GNAQ. Highlights:

Subject to FDA feedback and guidance, planning to initiate a Phase 1 clinical trial to evaluate darovasertib in SWS and, subject to further preclinical and clinical data, also in PWS patients with extensive involvement
General
IDEAYA continues to monitor Covid-19 and its potential impact on clinical trials and timing of clinical data results. Initiation of clinical trial sites, patient enrollment and ongoing monitoring of enrolled patients, including obtaining patient computed tomography (CT) scans, may be impacted for IDEAYA clinical trials evaluating IDE397 and darovasertib; the specific impacts are currently uncertain.

Corporate Updates
IDEAYA’s net losses were $11.6 million and $10.9 million for the three months ended September 30, 2021 and June 30, 2021, respectively. As of September 30, 2021, the company had an accumulated deficit of $158.5 million.

As of September 30, 2021, IDEAYA had cash, cash equivalents and marketable securities of $385.8 million. IDEAYA believes that its cash, cash equivalents and marketable securities will be sufficient to fund its planned operations into 2025. These funds will support the company’s efforts through potential achievement of multiple preclinical and clinical milestones across multiple programs.

Our updated corporate presentation is available on our website, at our Investor Relations page: View Source

Financial Results
As of September 30, 2021, IDEAYA had cash, cash equivalents and short-term marketable securities totaling $385.8 million. This compared to cash, cash equivalents and short-term and long-term marketable securities of $312.4 million at June 30, 2021. The increase was primarily due to $86.0 million in net proceeds received during the three months ended September 30, 2021 from issuance of common stock in an underwritten public offering on July 12, 2021, offset by cash used in operations and purchases of property and equipment.

Collaboration revenue for the three months ended September 30, 2021 totaled $9.0 million compared to $8.8 million for the three months ended June 30, 2021. Collaboration revenue was recognized for the performance obligations satisfied through September 30, 2021 under the GSK Collaboration Agreement.

Research and development (R&D) expenses for the three months ended September 30, 2021 totaled $15.5 million compared to $15.0 million for the three months ended June 30, 2021. The increase was primarily due to increases in fees to CROs and external consultants, and higher compensation expenses.

General and administrative (G&A) expenses for the three months ended September 30, 2021 totaled $5.2 million compared to $4.8 million for the three months ended June 30, 2021. The increase was primarily due to increases in IT expenses, and legal expenses.

The net loss for the three months ended September 30, 2021 was $11.6 million compared to $10.9 million for the three months ended June 30, 2021. Total stock compensation expense for the three months ended September 30, 2021 was $2.2 million compared to $2.1 million for the three months ended June 30, 2021.

On November 15, 2021 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders, reported financial results for the third quarter ended September 30, 2021 and highlighted recent developments (Press release, Inhibikase Therapeutics, NOV 15, 2021, View Source [SID1234595608]).

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Key Business and Clinical Highlights

Dosed first patient in the Phase 1b clinical trial of IkT-148009: In October 2021 Inhibikase dosed the first patient in its Phase 1b clinical trial of IkT-148009, a randomized, placebo-controlled trial to evaluate the safety, tolerability, and pharmacokinetics of IkT-148009. The trial will enroll a total of 24 patients with Parkinson’s disease and also assess non-motor and motor function, gut motility, and measures of alpha-synuclein aggregate clearance, as exploratory endpoints. The Company expects to complete this study and, with the approval of the U.S. Food and Drug Administration (FDA), advance into a Phase 2a study in 2022.
Extended Phase 1 clinical trial of IkT-148009 to higher doses: In October 2021, Inhibikase expanded dosing of IkT-148009 in older and elderly healthy volunteers up to a single 250 mg dose to identify the maximum tolerated dose. This extension was based on the safety and tolerability profile observed in the initial dose cohorts of the Phase 1 study.
Submitted interim three-month results from chronic toxicology studies of IkT-148009 to FDA: In October 2021, Inhibikase reported that it had submitted interim three-month results from its ongoing chronic toxicology studies of IkT-148009 in rats and non-human primates to the FDA. Data indicated that the toxicology profile of IkT-148009 improves with extended daily oral dosing and supports evaluation in Parkinson’s patients for up to three months.
Received grant from U.S. National Institutes of Health to evaluate IkT-148009 for the treatment of Multiple System Atrophy: In September 2021, Inhibikase was awarded a research grant from the U.S. National Institute of Neurological Disease and Stroke (NINDS), an Institute of the National Institutes of Health (NIH), to evaluate the mechanism of the MSA disease process and the therapeutic potential of IkT-148009 in preclinical studies.
"Over the past quarter, we have worked diligently to advance our lead candidate, IkT-148009 in multiple indications. We dosed the first Parkinson’s patient in our Phase 1b study as well as submitted interim chronic toxicology data to the FDA to support extended dosing of IkT-148009. We were also pleased to receive a grant from the NIH to evaluate IkT-148009 in a novel preclinical model of MSA, a neurodegenerative disease that may benefit from c-Abl inhibition," commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase. "As we look ahead, we expect to file our IND application for IkT-001Pro for the treatment of CML in the first quarter of 2022 as well as anticipate completing our Phase 1b study for Ikt-148009 in 2022."

Third Quarter Financial Results

Net Loss: Net loss for the quarter ended September 30, 2021, was $4.5 million, or $0.18 per share, compared to a net loss of $0.7 million, or $0.08 per share in the third quarter 2020.

R&D Expenses: Research and development expenses were $3.2 million for the quarter ended September 30, 2021 compared to $.1 million in the third quarter 2020. The increase was driven by a $0.3 million increase in grant related research expenditures and a $2.8 million increase in non-grant related research. The non-grant related research was expended primarily in connection with the Company’s Phase I Parkinson’s disease clinical trial.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended September 30, 2021 were $1.6 million compared to $0.6 million for the third quarter in 2020. The increase was the result of increased non-cash stock compensation expense of $0.1 million, increased director and officer’s liability insurance of $0.4 million related to the Company’s IPO in December 2020, increased legal fees, board fees, investor relation and consulting fees of $0.3 million relating to operating as a public company registrant since December 2020 and a net increase of $0.2 million for other normal operating expenses.

Cash Position: Cash and cash equivalents were $45 million as of September 30, 2021.

On November 15, 2021 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX System powered by Nano-Pulse Stimulation (NPS) technology, reported financial results for the third quarter of 2021 (Press release, Pulse Biosciences, NOV 15, 2021, View Source [SID1234595607]).

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Recent Highlights

Achieved third quarter 2021 revenue of $574 thousand, representing 12 Controlled Launch Program participants opting to acquire their CellFX Systems and transition to commercial use
Onboarded 68 CellFX System Controlled Launch Program participants to date and anticipate the remaining to be onboarded in Q4 to complete program enrollment across the U.S., Europe and Canada
Completed enrollment of 150 patients in an FDA IDE approved pivotal comparison study to assess the treatment of cutaneous non-genital warts using the CellFX System, the corresponding 510(k) submission is on track to be completed in the first half of 2022
Completed enrollment of 30 patients as part of a feasibility study to assess the treatment of basal cell carcinoma using the CellFX System, on track for tissue analysis to be completed in Q1 2022
Strengthened the executive leadership team with the appointment of Mitchell E. Levinson as Chief Strategy Officer, to spearhead the Company’s multi-specialty expansion efforts to leverage NPS technology, the CellFX platform and CellFX CloudConnect in applications outside of dermatology
Appointed healthcare industry executive Laureen DeBuono to its Board of Directors
"We made important progress across the business in the third quarter resulting in our first quarter of revenue as the initial Controlled Launch Program participants elected to purchase their CellFX Systems and Cycle Units for commercial use," said Darrin Uecker, President and CEO of Pulse Biosciences. "On the clinical front we continue to prioritize studies to support regulatory submissions to expand the CellFX System’s indications for use in dermatology. At the same time, we are pleased about the investigational preclinical work being done with NPS across other medical specialties. We are laying a foundation to drive value creation and maximize the full potential of the CellFX platform."

Third Quarter 2021 Results

Revenue for the three months ended September 30, 2021 was $574 thousand. System revenue for the three months ended September 30, 2021 was $490 thousand recognized on a non-cash basis resulting from the Controlled Launch Participants opting to acquire CellFX Systems. Cycle units revenue for the three months ended September 30, 2021 was $84 thousand resulting from the purchase of initial cycle units to be used with commercial systems.

Total GAAP gross loss* for the three months ended September 30, 2021 was ($0.2) million. Excluding non-cash expenses for stock-based compensation and depreciation and amortization, non-GAAP gross loss for the three months ended September 30, 2021 was ($0.1) million. As the business transitioned to commercial operations in the third quarter of 2021, all uncapitalized manufacturing operations costs are now recorded in cost of revenue. Prior to commercialization, these costs were recorded in research and development expenses.

Total GAAP operating expenses representing research and development, sales and marketing and general and administrative expenses for the three months ended September 30, 2021 were $14.1 million, compared to $12.9 million for the prior year period. Non-GAAP operating expenses for the three months ended September 30, 2021 were $12.3 million, compared to $10.0 million for the same period in the prior year. The year-over-year increase in operating expenses was primarily driven by the expansion of commercial and operational infrastructure, including increased headcount, to support commercialization activities.

GAAP net loss for the three months ended September 30, 2021 was ($14.3) million compared to ($12.9) million for the three months ended September 30, 2020. Non-GAAP net loss for the three months ended September 30, 2021, was ($12.4) million compared to ($10.0) million for the three months ended September 30, 2020.

Cash, cash equivalents and investments totaled $42.0 million as of September 30, 2021 compared to $47.4 million as of June 30, 2021. Cash used in the third quarter of 2021 totaled $13.8 million excluding net proceeds received in the June 2021 private placement. This compares with $8.3 million used in the same period in the prior year and $15.0 million used in the second quarter of 2021.

* Gross loss is calculated as total revenues less cost of revenues.

Reconciliations of GAAP to non-GAAP operating expenses and net loss have been provided in the tables following the financial statements in this press release. An explanation of these measures is also included below under the heading "Non-GAAP Financial Measures."

Webcast and Conference Call Information

Pulse Biosciences’ management will host a conference call today, November 15, 2021, beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 1-877-705-6003 for domestic callers or 1-201-493-6725 for international callers. A live and recorded webcast of the event will be available at View Source

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

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

Recent Business and Corporate Highlights:

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

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

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