On November 9, 2021 ChemoCentryx, Inc., (Nasdaq: CCXI), reported financial results for the third quarter ended September 30, 2021 and provided an overview of recent corporate highlights (Press release, ChemoCentryx, NOV 9, 2021, View Source [SID1234595126]).

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"TAVNEOS is approved and now launched in the U.S.," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "With these events, we have begun at last to achieve two of our most foundational aspirations: first, to improve the lives of patients’ who endure with severe disease, and second, to become an integrated biopharmaceutical company which has discovered, developed, and now markets a drug of its own creation. We hope too that the approval of TAVNEOS marks only the beginning of our promise to people living with major unmet medical needs. Our intent is to proceed now with discussions with regulators on how best to move forward TAVNEOS programs in C3G and HS, and we plan to initiate clinical development of TAVNEOS in lupus nephritis this coming year as well. Let’s also remember that our orally administered checkpoint inhibitor CCX559 is now in development for the treatment of cancer. I like to think we have important goals for patients, and a pipeline to match."

Key Highlights and Recent Developments

In October the Company announced FDA approval of TAVNEOS (avacopan) as an adjunctive treatment in adult patients with severe active ANCA-associated vasculitis (or ANCA vasculitis), specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) (the two main forms of ANCA vasculitis), in combination with standard therapy. TAVNEOS is the first orally-administered inhibitor of the complement 5a receptor to be approved by the FDA.
The Company launched TAVNEOS in the United States in October.
ChemoCentryx’s Kidney Health Alliance with Vifor Pharma provides Vifor Pharma with exclusive rights to commercialize TAVNEOS in markets outside of the United States:
In September the Company announced that Kissei Pharmaceutical Co., Ltd. (a sub-licensee of Vifor Pharma) had received approval from the Japanese Ministry of Health, Labor, and Welfare (MHLW) to market TAVNEOS in Japan for the treatment of patients with microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA), the two main forms of ANCA vasculitis.
In November a regulatory opinion is expected in Europe on the use of TAVNEOS in ANCA-associated vasculitis from the Committee for Human Medicinal Products (CHMP).
Data regarding TAVNEOS were presented at the annual meetings of the American College of Rheumatology and the American Society of Nephrology in November. Outcomes from the ADVOCATE trial in ANCA vasculitis demonstrated improvements in kidney function and health-related quality of life in the TAVNEOS group. Also, 52-week results from the ACCOLADE trial in C3G were presented; demonstrating attenuated progression of fibrosis (scarring) in the kidney was evident in the group of patients receiving TAVNEOS in the trial.
The Company plans to meet with the FDA to discuss the Phase III development of TAVNEOS in patients with Hurley Stage 3 (severe) Hidradenitis Suppurativa (HS) with the goal of initiating a Phase III clinical trial in those patients. In the Phase II AURORA trial, TAVNEOS demonstrated a statistically significant higher response than placebo in a pre-specified subgroup of Hurley Stage 3 patients, which will further guide clinical development.
The Company also plans a meeting with the FDA to discuss evidence of clinical benefit from the ACCOLADE trial of TAVNEOS in the very rare disorder C3 Glomerulopathy (C3G), for which there are no FDA approved therapies. In the ACCOLADE trial, TAVNEOS demonstrated statistically significant improvement in renal function as measured by pre-specified secondary endpoints of estimated Glomerular Filtration Rate (eGFR) and also improvement in the pre-specified endpoint of C3G Histology Index (HI) Disease Chronicity score (a measure of fibrotic progression), compared to placebo over 26 weeks of blinded treatment, though not a statistically significant improvement in the primary endpoint of the C3G HI Disease Activity Score (a measure of active inflammation). TAVNEOS was well tolerated in C3G patients.
The Company plans to initiate clinical development of TAVNEOS in patients with lupus nephritis in mid- 2022.
The Company continues to progress its Phase I clinical development of CCX559, a novel, orally-administered, PD-1/PD-L1 checkpoint inhibitor. As a next generation therapy, small molecule checkpoint inhibitors may have advantageous properties compared to approved monoclonal antibodies, such as better penetration into solid tumors, reduced immunogenicity, lack of Fc-mediated side effects, and the convenience of oral administration.
The Company ended Q3 with cash, cash equivalents and investments of approximately $372 million at September 30, 2021.
Third Quarter 2021 Financial Results

Revenue was $17.7 million for the third quarter of 2021, compared to $5.1 million for the same period in 2020. The increase in revenue from 2020 to 2021 was attributable to the $20.0 million milestone from Vifor for the September 2021 JNDA approval by the MHLW, for TAVNEOS in the treatment of ANCA vasculitis.

Research and development expenses were $20.0 million for the third quarter of 2021, compared to $18.6 million for the same period in 2020. The increase from 2020 to 2021 was primarily due to the manufacture of commercial drug supply in anticipation of the launch of TAVNEOS in the treatment of ANCA vasculitis and higher Phase I related expenses associated with the development of CCX559, our orally-administered small molecule checkpoint (PD-1/PD-L1) inhibitor. These increases were partially offset by lower Phase II related expenses due to the completion of the TAVNEOS AURORA Phase IIb clinical trial in patients with HS.

General and administrative expenses were $19.6 million for the third quarter of 2021, compared to $10.4 million for the same period in 2020. The increase from 2020 to 2021 was principally due to higher employee-related expenses, including those associated with our commercialization planning efforts, and higher professional fees.

Net loss for the third quarter of 2021 was $22.3 million, compared to net loss of $24.1 million for the same period in 2020.

Total shares outstanding at September 30, 2021 were approximately 69.9 million shares.

Cash, cash equivalents and investments totaled $371.5 million at September 30, 2021. The Company expects to end the year with cash, cash equivalents and investments in excess of $360 million.

Conference Call and Webcast

The Company will host a conference call and webcast today, November 9, 2021 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial (877) 303-8028 (Domestic) or (760) 536-5167 (International). The conference ID number is 7270887. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the call.

INDICATION

TAVNEOS (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
Serious hypersensitivity to avacopan or to any of the excipients

WARNINGS AND PRECAUTIONS
Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking TAVNEOS, including life-threatening events. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after start of therapy for six months and as clinically indicated thereafter. Monitor patients closely for hepatic adverse reactions, and consider pausing or discontinuing treatment as clinically indicated (refer to section 5.1 of the Prescribing Information). TAVNEOS is not recommended for patients with active, untreated and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risk and benefit before administering this drug to a patient with liver disease.

Serious Hypersensitivity Reactions: Cases of angioedema occurred in a clinical trial, including one serious event requiring hospitalization. Discontinue immediately if angioedema occurs and manage accordingly. TAVNEOS must not be re-administered unless another cause has been established.

Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation, including life threatening hepatitis B, was observed in the clinical program. Screen patients for HBV. For patients with evidence of prior infection, consult with physicians with expertise in HBV and monitor during TAVNEOS therapy and for six months following. If patients develop HBV reactivation, immediately discontinue TAVNEOS and concomitant therapies associated with HBV reactivation, and consult with experts before resuming.

Serious Infections: Serious infections, including fatal infections, have been reported in patients receiving TAVNEOS. The most common serious infections reported in TAVNEOS group were pneumonia and urinary tract infections. Avoid use of TAVNEOS in patients with active, serious infection, including localized infections. Consider the risks and benefits before initiating TAVNEOS in patients with chronic infection, at increased risk of infection or who have been to places where certain infections are common.

ADVERSE REACTIONS
The most common adverse reactions (≥5% of patients and higher in the TAVNEOS group vs. prednisone group) were: nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased, and paresthesia.

DRUG INTERACTIONS
Avoid coadministration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when co-administered with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Monitor for adverse reactions and consider dose reduction of certain sensitive CYP3A4 substrates.

Please see Full Prescribing Information and Medication Guide for TAVNEOS.

About TAVNEOSTM (avacopan)

TAVNEOS (avacopan), approved by the FDA as an adjunctive treatment of ANCA-associated vasculitis, is a first-in-class, orally-administered small molecule that employs a novel, highly targeted mode of action in complement-driven autoimmune and inflammatory diseases. While the precise mechanism in ANCA vasculitis has not been definitively established, TAVNEOS, by blocking the complement 5a receptor (C5aR) for the pro-inflammatory complement system fragment known as C5a on destructive inflammatory cells such as blood neutrophils, is presumed to arrest the ability of those cells to do damage in response to C5a activation, which is known to be the driver of ANCA vasculitis. TAVNEOS’s selective inhibition of only the C5aR is believed to leave the beneficial C5a pathway through the C5L2 receptor functioning normally.

ChemoCentryx is also developing TAVNEOS for the treatment of patients with C3 glomerulopathy (C3G), hidradenitis suppurativa (HS) and Lupus Nephritis (LN). The U.S. Food and Drug Administration granted TAVNEOS orphan drug designation for ANCA-associated vasculitis and C3G. The European Commission has granted orphan medicinal product designation for TAVNEOS for the treatment of two forms of ANCA-associated vasculitis: microscopic polyangiitis and granulomatosis with polyangiitis (formerly known as Wegener’s granulomatosis), as well as for C3G. TAVNEOS has not been approved for indications discussed as in development, and the safety and efficacy of TAVNEOS for those uses has not been established.

About ANCA-Associated Vasculitis

ANCA-associated vasculitis is a systemic disease in which over-activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This results in organ damage and failure, with the kidney as the major target, and is fatal if not treated. Currently, treatment for ANCA-associated vasculitis consists of courses of non-specific immuno-suppressants (cyclophosphamide or rituximab), combined with the administration of daily glucocorticoids (steroids) for prolonged periods of time, which can be associated with significant clinical risk including death from infection.

On November 9, 2021 Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, reported its financial results for the third quarter ended September 30, 2021 and provided a corporate update (Press release, Intra-Cellular Therapies, NOV 9, 2021, View Source [SID1234595183]).

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"We are excited about the progress we have made during the third quarter in the commercialization of CAPLYTA in schizophrenia and in the advancement of our development programs. In addition, our bipolar depression launch preparations are progressing well and we have substantially completed our sales force expansion," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.

Third Quarter Financial Highlights

Total revenues were $22.2 million for the third quarter of 2021, compared to $7.4 million of total revenues for the third quarter of 2020. Net product revenues of CAPLYTA were $21.6 million for the third quarter of 2021, compared to $7.4 million in net product revenues of CAPLYTA for the same period in 2020.
Cost of product sales were $2.0 million in the third quarter of 2021 compared to $0.6 million for the same period in 2020.
Research and development (R&D) expenses for the third quarter of 2021 were $27.0 million, compared to $10.3 million for the third quarter of 2020. This increase is due to higher lumateperone clinical trial costs and an increase in other development program costs.
Selling, general and administrative (SG&A) expenses were $70.5 million for the third quarter of 2021, compared to $52.5 million for the same period in 2020. This increase is primarily due to an increase in marketing and commercialization costs.
Net loss for the third quarter of 2021 was $76.9 million compared to a net loss of $55.2 million for the same period in 2020.
Cash, cash equivalents, restricted cash and investment securities totaled $478.7 million at September 30, 2021, compared to $658.8 million at December 31, 2020.
COMMERCIAL HIGHLIGHTS

Bipolar depression launch preparations continue to progress, and we have substantially completed our sales force expansion. If approved, we expect to launch CAPLYTA in bipolar depression immediately following U.S. Food and Drug Administration (FDA) approval.
Our hybrid commercialization model, combining virtual and in-person engagements, and our digital marketing initiatives continue to deliver consistent revenue and prescription growth despite COVID-19 disruptions affecting the medical care of patients with schizophrenia.
Third quarter CAPLYTA results reflect continued prescription growth, increasing total prescriptions by 15% versus the second quarter of 2021 and approximately 200% versus the same period in 2020.
CLINICAL HIGHLIGHTS

R&D Day Highlighting Development Programs:

The Company hosted an R&D day highlighting its research and development programs. Presentations and discussions from the Company’s management team and external key opinion leaders described different aspects of our broad pipeline, including our lumateperone, ITI-1284, PDE1 inhibitors and ITI-333 platforms.
Lumateperone:

Bipolar Depression Program: The lumateperone sNDAs for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate are under review by the FDA. The Prescription Drug User Fee Act (PDUFA) target action date is December 17, 2021 for these applications.
Adjunctive MDD program: Patient enrollment has been initiated in global studies 501 and 502. These are Phase 3 double blind, placebo-controlled, 6-week studies evaluating lumateperone 42mg as adjunctive treatment to anti-depressants for patients having an inadequate response to antidepressant therapy. The primary endpoint is change from baseline versus placebo on the MADRS total score at week 6, and the CGI-S scale is the key secondary endpoint.
Mixed Features program: Study 403 is ongoing and is evaluating lumateperone 42mg in patients with MDD and in patients with bipolar depression who exhibit mixed features. We expect to complete this study in the second half of 2022.
Lumateperone Long Acting Injectable (LLAI) formulation: Study ITI-007-025, a Phase 1 single ascending dose study of LLAI, is ongoing. We expect to complete this study later this year.
Publications: Announced the publication of Study 404, a Phase 3 clinical study evaluating lumateperone as monotherapy in patients with bipolar depression. The article titled "Efficacy and Safety of Lumateperone for Major Depressive Episodes Associated with Bipolar I or Bipolar II Disorder: A Phase 3 Randomized Placebo-Controlled Trial," was published online in The American Journal of Psychiatry.
Other Programs:

ITI-1284 program: We have initiated our program for the development of ITI-1284-ODT-SL for the treatment of agitation in patients with probable Alzheimer’s disease. Clinical conduct in this program is expected to commence early in 2022. Studies in dementia-related psychosis and certain depressive disorders in the elderly are planned for the first half of 2022.
Phosphodiesterase type I inhibitor (PDE1) program:
Our Phase 2 clinical program evaluating lenrispodun (ITI-214) in Parkinson’s disease has been initiated, and we expect to commence patient enrollment in the first half of 2022.
We announced four publications highlighting the beneficial effects of PDE1 inhibition with lenrispodun on cardiovascular function in patients with heart failure and in age-related vascular changes in preclinical models associated with stiffening of arteries, vascular endothelial dysfunction, and increased inflammation. In addition, a novel cellular mechanism by which PDE1 stimulates cardiac contraction was described in one of these studies. These findings have broad implications, as cardiovascular dysfunction and inflammation play important roles across multiple chronic and age-related diseases.
ITI-333 program in opioid use disorder: ITI-333 is a novel compound that acts as a partial agonist at mu-opioid (MOP) receptors and as antagonists at the serotonin 5HT2A receptors. At MOP receptors, it acts as a partial agonist signaling through G-protein pathways, but it acts as an antagonist at beta-arrestin pathways. These characteristics and results from early clinical and preclinical models highlight the potential of ITI-333 to address important unmet therapeutic needs in opioid use disorder and pain. A Phase 1 single ascending dose study, evaluating the safety, tolerability and pharmacokinetics of ITI-333 in healthy volunteers, is ongoing. Results from this study are anticipated in the fourth quarter of 2021.
Conference Call and Webcast Details

The Company will host a live conference call and webcast today at 8:30 AM Eastern Time to discuss the Company’s financial results and provide a corporate update. The live webcast and subsequent replay may be accessed by visiting the Company’s website at www.intracellulartherapies.com. Please connect to the Company’s website at least 5-10 minutes prior to the live webcast to ensure adequate time for any necessary software download. Alternatively, please call 1-(844) 835-6563 (U.S.) or 1-(970) 315-3916 (international) to listen to the live conference call. The conference ID number for the live call is 3650108. Please dial in approximately 10 minutes prior to the call.

CAPLYTA (lumateperone) is indicated for the treatment of schizophrenia in adults. CAPLYTA is available in 42 mg capsules.

Important Safety Information

Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.

Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g., allergic dermatitis, papular rash, and generalized rash), and urticaria.

Warnings & Precautions: Antipsychotic drugs have been reported to cause:

Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room.
Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.
Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.
Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.
Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
Sleepiness and Trouble Concentrating. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.
Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers, moderate or strong CYP3A4 inhibitors and UGT inhibitors.

Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended. Use of CAPLYTA should be avoided in patients with moderate or severe liver problems.

Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).

Please click here to see full Prescribing Information including Boxed Warning.

About CAPLYTA (lumateperone)

CAPLYTA 42mg/day is an oral, once daily atypical antipsychotic approved for the treatment of schizophrenia of adults. While the mechanism of action of CAPLYTA in the treatment of schizophrenia is unknown, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

Lumateperone is being investigated for the treatment of bipolar depression, depression and other neuropsychiatric and neurological disorders. CAPLYTA is not FDA approved for these disorders.

On November 9, 2021 Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics and monitoring company with the mission to improve patient outcomes by providing clear insights that inform critical decisions in the diagnosis, treatment, and monitoring of cancer, reports financial results for the third quarter 2021 ended September 30, 2021, along with a corporate update (Press release, Oncocyte, NOV 9, 2021, View Source [SID1234595212]).

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"The recently announced clinical launch of our DetermaIO test, via an early access program (EAP), is an important milestone to inform immunotherapy decisions which strengthens Oncocyte’s differentiated position in precision diagnostics," said Ron Andrews, Chief Executive Officer and President of Oncocyte. "We believe that the combination of DetermaIO with our comprehensive genomic profiling test DetermaTx, expected to be launched late in the first quarter of 2022 upon completion of the DetermaIO EAP program, will offer the most complete precision diagnostic solution to inform cancer treatment decisions for the 1.8 million patients diagnosed with cancer in the United States each year and allows us to enter a total available market of $5 billion. This combined offering is further differentiated by its ability to deliver comprehensive treatment decision information while conserving the limited tumor tissue sample available for testing, with industry leading turnaround time. We are very encouraged with the response to our recently announced early access program for DetermaIO, we have begun onboarding the accounts, and are excited to receive our first clinical patient samples in the coming weeks. Our clinical studies have now reported results for over 1,000 patients, validated DetermaIO in four different tumor types, and shown consistent outperformance of the current tests being used to select patients for treatment."

Mr. Andrews continued, "We’ve continued our progress with DetermaRx and, despite significant disruptions in early-stage lung cancer surgeries over the summer due to the surge of the COVID-19 Delta variant, we generated 65% year over year growth in test volume. We also continue to deliver on our two metrics used to measure test adoption during the current market environment: new hospital onboards increased by42 facilities, growing 24% quarter over quarter, and our ordering physicians grew by 66 doctors or 22% quarter over quarter. We have now established a solid install base that is poised to grow our sample volume and revenue once early-stage lung cancer surgeries return to pre-pandemic levels."

"With the issuance of our IP in blood-based monitoring for transplant rejection, we now have a clear path to launching our own LDT test into the large transplant rejection market in the U.S. and Europe. Oncocyte expects to complete 2021 with solid momentum toward our goal of building a compelling and powerful portfolio of molecular diagnostic tests. As a complement to this progress, our recent appointment of Gisela Paulsen as Chief Operating Officer brings additional world-class talent to the experienced leadership team at Oncocyte and comes on board at an important time as we expand our operations to support the anticipated growth ahead."

Third Quarter and Recent Highlights Include:

●Announced the clinical launch of the DetermaIO immunotherapy response prediction test via an early access program.

●Oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) on randomized clinical trial data definitively established DetermaIO as a predictive biomarker of immunotherapy response. In the triple negative breast cancer (TNBC) NeoTRIPaPDL1 study, DetermaIO outperformed 80 other immune signatures.

●Published a peer-reviewed study in the journal Cancers with investigators from leading academic institutions MD Anderson and Yale demonstrating the predictive potential for DetermaIO. Study data showed that DetermaIO demonstrates superior accuracy compared to standard of care PD-L1 immunohistochemistry (IHC) for prediction of a patient’s response to immunotherapy in TNBC. Previous data has been presented in lung, bladder, renal and kidney cancers suggesting a broad pan-cancer utility of the test.

●Strengthened transplant IP portfolio with issuance of a U.S. patent covering digital PCR technology for early detection of organ transplant rejection, building upon prior issued U.S. and EU patent for quantification of donor derived cfDNA, supporting the launch of TheraSure Transplant Monitor as an LDT in the U.S.

●Launched and completed site enrollment of the first Real-World Evidence (RWE) registry intended to evaluate biomarker adoption and precision medicine in creating personalized treatment options for early-stage lung cancer patients, with enrollment targeting more than 1,000 patients at 25 sites across the U.S. beginning in Q4 2021.

Corporate

·Appointed industry veteran Gisela A. Paulsen as Chief Operating Officer in October 2021.

Third Quarter 2021 Financial Results

On September 30, 2021, Oncocyte had cash, cash equivalents and marketable securities of $44.3 million, as compared to $7.8 million on December 31, 2020.

Oncocyte currently derives its revenues from the sale of its lung cancer test, DetermaRx, which was commercially launched in early 2020 and pharma services generated by its wholly owned subsidiary, Insight Genetics, which was acquired on January 31, 2020. During the first quarter of 2021, after accumulating additional history of cash receipts and other factors considered by management for Medicare Advantage-covered DetermaRx tests, including the recently published Medicare rate, the Company transitioned to the accrual basis for tests covered by Medicare Advantage insurance plans. Oncocyte will continue to recognize revenues for commercial and other payors on a cash basis until we have reimbursement contracts with those payors. At that point, those contracts will also progress to the accrual basis for DetermaRx tests. Until that time, for all payors other than Medicare and Medicare Advantage, Oncocyte expects to recognize revenue for DetermaRx tests performed on a cash basis.

Revenues for the three months ended September 30, 2021, were approximately $1.0 million, generated from three sources: DetermaRx tests, pharma services, and licensing revenues. This compares to revenues of $555,000 for the three months ended September 30, 2020, a year over year growth rate of 77%. DetermaRx samples received this quarter grew 3% compared to last quarter, primarily due to the impact of the Delta Variant on surgical volumes in key sales regions of the United States and 65% versus Q3 2020 .

Cost of revenues for the third quarter 2021 were approximately $1.9 million, which includes approximately $1.0 million in non-cash amortization expenses from the Razor Genomics and Insight Genetics acquisitions. The cost of our Razor asset amortization, which is a non-cash amortization expense over the remaining life of the Razor patent, will be included in cost of revenues each quarter. Cost of revenues also include testing services we perform for our pharma customers.

Research and development expenses for the third quarter of 2021 were $3.1 million as compared to $2.6 million for the same period in 2020, an increase of $0.5 million, representing the increased investment in clinical studies to support the commercialization of the portfolio of tests in the pipeline.

General and administrative expenses for the third quarter of 2021 were $5.5 million, as compared to $5.0 million for the same period in 2020, an increase of approximately $0.5 million.

Sales and marketing expenses for the three months ended September 30, 2021 were $2.9 million, as compared to $1.6 million for the same period in 2020. The increase was primarily due to personnel and related expenses resulting from the ramp up in sales and marketing activities for DetermaRx, as well as market development investments in preparation for the launch of new products later this year.

Operating losses, as reported, for the third quarter of 2021 were $13.6 million, as compared to $6.2 million for the third quarter of 2020. Operating losses, on an adjusted basis, were $9.3 million, an increase of $3.2 million from $6.1 million as compared to the third quarter of 2020.

Oncocyte has provided a reconciliation between GAAP and non-GAAP operating losses in the financial tables, included with this earnings release, which it believes is helpful in understanding its ongoing operations.

For the third quarter ended September 30, 2021, Oncocyte reported a net loss of $13.8 million, or ($0.15) per share, as compared to $6.8 million, or ($0.10) per share, for the third quarter ended September 30, 2020.

Cash used in operations was approximately $11.0 million for the third quarter of 2021.

Conference Call Information

The Company will host a conference call today, November 9th at 4:30 pm EDT / 1:30 pm PDT to discuss the results along with recent corporate developments. The dial-in number in the U.S./Canada is 877-407-9716; for international participants, the number is 201-493-6779. For all callers, please refer to Conference ID: 13722620. To access the live webcast, go to the investor relations section on the Company’s website, or by clicking here View Source The webcast replay will be available on the Oncocyte website for 90 days following the completion of the call.

On November 8, 2021 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported its financial results for the third quarter ending September 30, 2021 (Press release, Akoya Biosciences, NOV 8, 2021, View Source [SID1234594696]).

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"Our strong performance in the third quarter shows that we have great momentum in all phases of our business," said Brian McKelligon, Chief Executive Officer, Akoya Biosciences. "We generated strong quarterly revenue, and with over 650 installed instruments worldwide, we are a leader in the fast-growing spatial biology market. We continue to see robust growth and interest in our platforms from discovery to translational and clinical research. We also made key additions to our management team and Board of Directors, as we continue to attract industry leaders to help drive our business forward. Expansion in our commercial and R&D organizations will help drive product development and growth, while CLIA certification for our ABS lab, which is expected before year-end, will enhance our ability to support larger and later stage clinical trials."

Third Quarter Financial Highlights

Total revenue was $13.5 million in the third quarter of 2021, compared to $10.0 million in the prior year period; an increase of 35%.
Product revenue was $10.9 million in the third quarter of 2021, compared to $7.9 million in the prior year period; an increase of 38%.
Services and other revenue totaled $2.6 million in the third quarter of 2021, compared to $2.1 million in the prior year period.
Gross profit was $8.5 million in the third quarter of 2021, compared to $6.0 million in the prior year period; an increase of 42% and gross profit margin was 62.7% for the current quarter.
33 instruments were sold in the third quarter of 2021; 16 CODEX, 17 Phenoptics (includes Polaris, Vectra, and Mantra).
Instrument installed base of 651 as of September 30, 2021; CODEX 161, Phenoptics 490.
Year to date Financial Highlights

Total revenue was $38.8 million YTD, compared to $29.5 million in the prior year period; an increase of 31%.
Product revenue was $31.6 million YTD, compared to $23.0 million in the prior year period; an increase of 37%.
Services and other revenue totaled $7.2 million YTD, compared to $6.6 million in the prior year period.
Gross profit was $24.0 million YTD, compared to $18.0 million in the prior year period; an increase of 33% and gross profit margin was 61.9%.
101 instruments were sold YTD; 49 CODEX, 52 Phenoptics (includes Polaris, Vectra, and Mantra).
Third Quarter Business Highlights

$13.5 million for the third quarter of 2021 is the highest quarterly revenue number in Akoya history.
As of September 30, 2021, through the first nine months of the year, there have been 192 publications featuring the Akoya platform, compared with 109 for calendar year 2020.
Announced the inaugural members of the Akoya Imaging Innovators (I2) Network, a collaboration of pioneering scientists from world-class research organizations, with ambitions to advance the field of spatial biology by exploring novel approaches using Akoya’s CODEX platform for single-cell spatial phenotyping and analysis.
Appointment of Myla Lai-Goldman, MD to our Board of Directors, a visionary and seasoned executive in the diagnostics industry with over 30 years of leadership experience in diagnostic research and development, as well as commercialization, at innovative organizations.
Appointment of Pascal Bamford, PhD as Executive Vice President of R&D, a pioneer in genomic clinical and diagnostic testing who brings deep scientific and operational experience leading teams in developing and implementing successful innovative digital pathology products and cloud-based analysis platforms.
$120.2 million of cash and cash equivalents as of September 30, 2021, providing for sufficient runway to make key investments in the business.
2021 Guidance

Akoya expects fourth quarter revenue of at least $15 million, and full year revenue of at least $53.8 million. Full year guidance has been increased from the prior guidance which had a range of $52.5 million to $53.0 million.

Webcast and Conference Call Details

Akoya will host a conference call today, November 8, 2021, at 5:00 p.m. Eastern Time to discuss its third quarter 2021 financial results. The dial-in numbers are (833) 562-0146 for domestic callers or (661) 567-1226 for international callers, followed by Conference ID: 6875504. A live webcast of the conference call will be available on the "Investors" section of the Company’s website at View Source The webcast will be archived on the website following the completion of the call for three months.

On November 8, 2021 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of targeted drugs for the treatment of cancer, reported financial results for the third quarter ended September 30, 2021 and provided a corporate update (Press release, Cellectar Biosciences, NOV 8, 2021, View Source [SID1234594712]).

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Third Quarter and Recent Corporate Highlights

Announced the completion of the Part A portion of a safety and tolerability study of iopofosine I-131 (iopofosine) in combination with external beam radiation (EBRT) in relapsed or refractory head and neck cancer. The investigator-initiated study is being conducted by the University of Wisconsin as part of a Specialized Program of Research Excellence (SPORE) grant awarded by the National Cancer Institute (NCI).
The study objective is to determine if combining iopofosine with EBRT can reduce the amount or fractions (doses) of EBRT required, which has the potential to diminish the number and severity of EBRT associated adverse events.
Preliminary data suggest that iopofosine is safe and tolerated in combination with EBRT for relapsed or refractory head and neck cancer.

Awarded a peer-reviewed National Institutes of Health (NIH) Phase II Small Business Innovation Research (SBIR) grant of approximately $2 Million from the NCI. The grant will support the ongoing global pivotal study and clinical development of iopofosine in Waldenstrom’s macroglobulinemia (WM).

Announced collaboration with BBK Worldwide to provide new concierge services for patients participating in Cellectar’s clinical studies. These services are designed to improve patient’s and their caregiver’s access to high quality care and innovative treatments for their cancer.

Announced commercial manufacturing and supply agreement with Evergreen Theragnostics, a global radiopharmaceutical contract development and manufacturing organization (CDMO), to provide long term commercial supply of iopofosine and clinical study material for the company’s pivotal study in WM, as well as for the ongoing Phase 1 and Phase 2 clinical studies.
"We remain highly focused on driving our pivotal study of iopofosine in Waldenstrom’s and in parallel advancing the ongoing Phase 2b clinical study for late line, hexa-drug refractory multiple myeloma patients along with our two Phase 1 studies in pediatric and head and neck cancers" said James Caruso, president and CEO of Cellectar. "Our collaboration with Evergreen Theragnostics expands our manufacturing capabilities to help reduce the risks inherent in single sourcing of drug supply and provides the capability to scale supply for future studies and potential commercialization. The recent deal with BBK Worldwide will allow us to more efficiently serve our patients and remove barriers to study participation as we continue to develop iopofosine in WM and other oncology indications. With $40.3 million in cash and cash equivalents as of September 30, we are supported by a strong balance sheet that will fund our expected clinical and regulatory milestones into the second half of 2023."

Third Quarter Financial Highlights

Cash and Cash Equivalents: As of September 30, 2021, the company had cash and cash equivalents of $40.3 million compared to $57.2 million at December 31, 2020. Cash used in operating activities was approximately $18.1 million during the nine months ended September 30, 2021 as compared to $10.1 million during the nine months ended September 30, 2020.
Research and Development Expense: R&D expense for the three months ended September 30, 2021 was $3.9 million, compared to $2.7 million for the three months ended September 30, 2020. The cumulative R&D spending for the first nine months of 2021 was $13.2 million as compared to $7.8 million for the first nine months of 2020. The increase in R&D expense year-to-date in 2021 was primarily a result of start-up costs for our WM pivotal study, clinical project costs and general research and development costs offset by a decrease in manufacturing and related costs.
General and Administrative Expense: G&A expense for the three months ended September 30, 2021 was $1.9 million compared to $1.2 million for the three months ended September 30, 2020. The cumulative G&A spending for the first nine months of 2021 were $5.0 million as compared to $3.7 million for the first nine months of 2020. The increase in G&A expense year-to-date in 2021 was primarily a result of an increase in professional fees and insurance, personnel costs and stock-based compensation expense.
Net Loss: The net loss attributable to common stockholders for the three months ended September 30, 2021 was ($5.8) million, or ($0.10) per share, compared to ($3.9) million, or ($0.15) per share, in 2020. Net loss attributable to common stockholders for the nine months ended September 30, 2021 was ($18.2) million, or ($0.34) per share, compared to ($11.5) million, or ($0.69) per share, in 2020.