On November 5, 2020 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein, p53, reported financial results for the three and nine months ended September 30, 2020 and provided a business update (Press release, Aprea, NOV 5, 2020, View Source [SID1234570077]).

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"We made solid progress during the third quarter across our development pipeline as we approach top-line data from the Phase 3 clinical trial evaluating eprenetapopt with azacitidine for the treatment of front-line TP53 mutant myelodysplastic syndromes (MDS) patients by year-end 2020" said Christian S. Schade, Chairman and Chief Executive Officer of Aprea. "We continue to execute on our goal of expanding the clinical opportunities for our p53 reactivator programs, including expansion of our front-line AML clinical trials, enrollment of the first patients in our solid tumor trial, initiation of our lymphoma trial and clearance from FDA to proceed with the Phase 1 trial of our next-generation p53 reactivator, APR-548."

Business Operations Update:

The Company is conducting, supporting, and planning multiple clinical trials of eprenetapopt (APR-246):

Pivotal Phase 3 MDS Trial—The Company has completed the full enrollment of 154 patients in its pivotal Phase 3 randomized, controlled trial evaluating eprenetapopt with azacitidine as frontline therapy in HMA-naïve TP53 mutant myelodysplastic syndromes (MDS) patients with a primary endpoint of complete remission (CR) rate. The Company remains confident it will have top-line data available by year-end 2020.

Phase 2 MDS/AML Post-Transplant Trial—The Company has completed the target enrollment of 31 patients in its single-arm, open-label Phase 2 trial evaluating eprenetapopt with azacitidine as post-transplant maintenance therapy in TP53 mutant MDS and acute myeloid leukemia (AML) patients who have received an allogeneic stem cell transplant.

Phase 1/2 AML Trial—The Company is currently enrolling its Phase 1/2 trial evaluating the safety, tolerability, and preliminary efficacy of eprenetapopt therapy in TP53 mutant AML patients. The lead-in portion of the trial evaluated the tolerability of eprenetapopt with venetoclax, with or without azacitidine, and no dose-limiting toxicities were observed in 12 patients receiving either regimen. Based on these results, the Company has expanded the trial to treat approximately 30 additional frontline TP53 mutant AML patients with the combination of eprenetapopt, venetoclax and azacitidine. The Company also plans to activate a separate cohort in the trial to evaluate the combination of eprenetapopt with azacitidine in approximately 30 frontline TP53 mutant AML patients.

Phase 1 NHL Trial—The Company has designed and plans to conduct a Phase 1 clinical trial in relapsed/refractory TP53 mutant chronic lymphoid leukemia (CLL) assessing eprenetapopt with venetoclax and rituximab, and eprenetapopt with ibrutinib in order to further assess eprenetapopt in hematological malignancies. A poster describing the clinical trial has been accepted for presentation at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (abstract # 1311) on December 5, 2020 from 10:00 am to 6:30 pm eastern time. The Company is targeting the first patient to be enrolled in the fourth quarter of 2020.

Phase 1/2 Solid Tumor Trial—Based on in vivo data suggesting synergistic activity between eprenetapopt and immuno-therapy agents including anti-PD-1 antibody, the Company has designed and is conducting Phase 1/2 clinical trials in relapsed/refractory gastric, bladder and non-small cell lung cancers assessing eprenetapopt with anti-PD-1 therapy. Five patients have been enrolled in the safety review cohort of this trial.

APR-548 — The Company’s second product candidate, APR-548, is a pre-clinical, next-generation p53 reactivator with the potential for oral administration. APR-548 exhibits high oral bioavailability in preclinical testing and is being developed in an oral dosage form. The Company completed Investigational New Drug, or IND, enabling preclinical studies of APR-548 and filed an IND with the FDA. The Company received clearance from the FDA in October 2020 to initiate Phase 1 clinical trials for APR-548. The Company anticipates enrollment in the Phase 1 clinical trial to begin in the first quarter of 2021.
Third Quarter Financial Results

Cash and cash equivalents: As of September 30, 2020, the Company had $101.1 million of cash and cash equivalents compared to $130.1 million of cash and cash equivalents as of December 31, 2019. The Company expects cash burn for the full year 2020 to be between $35.0 million $40.0 million. The Company believes its cash and cash equivalents as of September 30, 2020 will be sufficient to meet its current projected operating requirements into 2023.

Research and Development (R&D) expenses: R&D expenses were $8.8 million for the quarter ended September 30, 2020, compared to $4.9 million for the comparable period in 2019. The increase in R&D expenses was primarily related to the continued development of the Company’s lead product candidate, eprenetapopt in the following ongoing clinical trials; our pivotal Phase 3 clinical trial of eprenetapopt with azacitidine for frontline treatment of TP53 mutant MDS, our Phase 1/2 clinical trials in relapsed/refractory gastric, bladder and non-small cell lung cancers assessing eprenetapopt with anti-PD-1 therapy, our Phase 1 clinical trial in relapsed/refractory TP53 mutant chronic lymphoid leukemia (CLL) assessing eprenetapopt with venetoclax and rituximab, and eprenetapopt with ibrutinib and our Phase 2 post-transplant MDS/AML clinical trial.

General and Administrative (G&A) expenses: G&A expenses were $3.5 million for the quarter ended September 30, 2020, compared to $2.3 million for the comparable period in 2019. The increase in G&A expenses was primarily due to increased non-cash stock-based compensation, increased insurance expense and increased commercial development expense.

Net loss: Net loss was $12.3 million, or $0.58 per share for the quarter ended September 30, 2020, compared to a net loss of $6.2 million, or $5.29 per share for the quarter ended September 30, 2019. The Company had 21,186,827 shares of common stock outstanding as of September 30, 2020.

On November 5, 2020 Nektar Therapeutics (NASDAQ: NKTR) reported financial results for the third quarter ended September 30, 2020 (Press release, Nektar Therapeutics, NOV 5, 2020, View Source [SID1234570076]).

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Cash and investments in marketable securities at September 30, 2020 were approximately $1.2 billion as compared to $1.6 billion at December 31, 2019.

"In Q3, we’ve continued to successfully advance our late-stage registrational and early stage studies for our immune-oncology pipeline of candidates while navigating challenges in the current COVID-19 environment," said Howard W. Robin, President and CEO of Nektar. "Enrollment in our five registrational trials of bempegaldesleukin in combination with nivolumab is going well and our partner BMS recently initiated a new clinical study in renal cell carcinoma to evaluate the doublet therapy with a TKI agent. We are also pleased to report that we are ahead of our enrollment targets for the Phase 2 PROPEL study of bempegaldesleukin with pembrolizumab in patients with metastatic non-small cell lung cancer and we look forward to sharing the initial data from this important study in the first part of 2021."

"Next week’s 2020 SITC (Free SITC Whitepaper) meeting will feature data presentations that showcase the strength of Nektar’s immune-oncology pipeline, including an oral presentation of 2 1/2 year data for metastatic melanoma patients treated with bempegaldesleukin plus nivolumab, and promising early data for NKTR-255, our IL-15 cytokine, as well as NKTR-262, our TLR agonist program," continued Robin. "In immunology, we presented positive new data at ACR 2020 this week highlighting the disease activity observed in lupus patients with NKTR-358, our T regulatory cell agent. We are exceptionally pleased that our partner Lilly is undertaking a broad clinical development program for NKTR-358 with two Phase 1b studies in atopic dermatitis and psoriasis, a Phase 2 study underway in patients with systemic lupus erythematosus and a new Phase 2 study being planned in ulcerative colitis."

Summary of Q3 2020 Financial Results

Revenue in the third quarter of 2020 was $30.0 million compared to $29.2 million in the third quarter of 2019. Year-to-date revenue for 2020 was $129.5 million compared to $80.8 million for the first nine months of 2019. Revenue was higher due to the recognition of $50.0 million in total milestones from Bristol-Myers Squibb related to the start of two new registrational trials of bempegaldesleukin plus Opdivo in adjuvant melanoma and muscle-invasive bladder cancer.

Total operating costs and expenses in the third quarter of 2020 were $133.1 million compared to $128.0 million in the third quarter of 2019. Total operating costs and expenses in the first nine months of 2020 were $443.8 million compared to $411.2 million in the first nine months of 2019. Year-to-date operating costs and expenses increased primarily as a result of $45.2 million in impairment charges in the first quarter of 2020 resulting from the discontinuation of the NKTR-181 program, partially offset by a decrease in R&D expense.

R&D expense in the third quarter of 2020 was $100.5 million compared to $99.0 million for the third quarter of 2019. For the first nine months of 2020, R&D expense was $306.0 million compared to $324.2 million in the first nine months of 2019. Excluding pre-commercial manufacturing costs for NKTR-181 incurred during 2019, research and development expense increased for the third quarter and the first nine months of 2020 primarily due to increases in clinical development costs, partially offset by a decrease in manufacturing costs for clinical trial materials.

Net loss for the third quarter of 2020 was $108.6 million or $0.61 basic and diluted loss per share compared to a net loss of $98.6 million or $0.56 basic and diluted loss per share in the third quarter of 2019. Net loss in the first nine months of 2020 was $327.2 million or $1.84 basic and diluted loss per share compared to a net loss of $328.5 million or $1.88 basic and diluted loss per share in the first nine months of 2019.

Third Quarter 2020 and Recent Business Highlights

In November 2020, Nektar presented new data from its NKTR-358 program at the American College of Rheumatology (ACR) virtual meeting. Data from the Phase 1b study in patients with mild to moderate systemic lupus erythematosus (SLE) showed that NKTR-358 produced a dose-dependent increase in expression of Treg activation markers, providing a rationale for continued development in SLE and other inflammatory indications.
In October 2020, Nektar received IND clearance and began site initiation activities for a Phase 1/2 study of NKTR-255 in patients with solid tumors. The study will evaluate NKTR-255 in combination with cetuximab in two distinct groups of highly refractory patients with colorectal cancer or head and neck cancer.
In October 2020, Nektar initiated a Phase 1b clinical study of bempegaldesleukin in adult patients with mild COVID-19 infection. The randomized, double-blind, placebo-controlled trial is designed to assess the safety, tolerability, and pharmacokinetic and pharmacodynamic profile of bempegaldesleukin in adult patients with mild COVD-19.
In September 2020, a Phase 1/2 study was initiated by Nektar partner BMS in patients with clear cell renal cell carcinoma to evaluate the triplet combination of bempegaldesleukin with nivolumab in combination with a tyrosine-kinase inhibitor.
In August 2020, Vaccibody AS and Nektar announced that the first patient had been dosed in the Phase 1/2a study evaluating bempegaldesleukin with VB10.NEO, Vaccibody’s personalized neoantigen cancer vaccine, in patients with advanced squamous cell carcinoma of the head and neck.
The company also announced upcoming presentations at the following scientific congress:

2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting:

Oral Presentation: "REVEAL: Phase 1 dose-escalation study of NKTR-262, a novel TLR7/8 agonist, plus bempegaldesleukin: local innate immune activation and systemic adaptive immune expansion for treating solid tumors"
Presenter: Dr. Adi Diab, MD Anderson Cancer Center
Session: Session 102: Combinatorial Therapies
Date and Time: Wednesday, November 11; 11:15 a.m. – 1:10 p.m. Eastern Standard Time
Oral Presentation: "Progression-free survival and biomarker correlates of response with BEMPEG plus NIVO in previously untreated patients with metastatic melanoma: results from the PIVOT-02 study"
Presenter: Dr. Adi Diab, MD Anderson Cancer Center
Session: Session 104: Concurrent Rapid Oral Abstract Presentation: Clinical
Date and Time: Wednesday, November 11; 1:30 p.m. – 2:00 p.m. Eastern Standard Time
Poster Presentation: "First-in-human phase I study of NKTR-255 in patients with relapsed/refractory hematologic malignancies", Shah, N., et al.
Session: Virtual Poster Hall
Date and Time: Poster presentations will be available beginning November 9, 2020
Poster Presentation: "Bempegaldesleukin (BEMPEG; CD122-preferential IL-2 pathway agonist)) and NKTR-262 (TLR7/8 agonist) combination treatment pairs local innate immune activation with systemic CD8+ T cell expansion to enhance anti-tumor immunity", Rolig, A., et al.
Session: Virtual Poster Hall
Date and Time: Poster presentations will be available beginning November 9, 2020
Conference Call to Discuss Third Quarter Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time, today, Thursday, November 5, 2020.

This press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through Tuesday, December 1, 2020.

On November 5, 2020 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported financial results for the three months ending September 30, 2020 (Press release, Quanterix, NOV 5, 2020, View Source [SID1234570075]).

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"We have made important advances in Alzheimer’s, MS and COVID testing and with our platform in Q3 2020 delivering another strong quarter of growth, despite continued headwinds associated with the pandemic," said Kevin Hrusovsky, Chairman, Chief Executive Officer, President, Quanterix. "We launched important Neurology assays including pTau-181 and a comprehensive N4PE four plex, secured an $18.2M NIH RADx contract to accelerate development, manufacturing scale-up and deployment of our novel high-throughput SARS-CoV-2 Antigen test, entered a non-exclusive IVD license agreement with Abbott, initiated surveillance studies with a large US Payer and raised nearly $100m in capital, making Q3’2020 one of our more successful quarters in our history. We are encouraged by our operational and strategic momentum and believe our unique ability to detect Neurology biomarkers such as Nf-L and pTau-181 is delivering on the promise of early disease detection from minimally invasive samples. Most importantly, we are pleased with our growth potential associated with COVID, MS and upcoming Alzheimer’s trials."

Third Quarter 2020 Financial Highlights

Key financial results from the third quarter of 2020 are shown below:

· Q3 GAAP total revenue, which includes one-time License and Grant Revenue, was $31.4M versus prior year Q3 of $14.9M;
· Q3 non-GAAP total revenue was $18.3M versus prior year Q3 of $14.9M, an increase of 22%;
· Q3 GAAP product revenue was $11.7M versus prior year Q3 of $10.7M, an increase of 9%;
· Q3 GAAP service and other revenue was $6.6M versus prior year Q3 of $4.2M, an increase of 56%

YTD 2020 Financial Highlights

Key financial results for YTD 2020 are shown below:

· YTD GAAP total revenue was $60.2M versus prior year YTD of $40.8M
· YTD non-GAAP total revenue was $47.1M versus prior year YTD of $40.8M, an increase of 15%;
· YTD GAAP product revenue was $28.3M versus prior year YTD of $29.1M, a decrease of 3%;
· YTD GAAP service and other revenue was $18.6M versus prior year YTD of $11.8M, an increase of 58%

For additional information on the non-GAAP financial measures included in this press release, please see "Use of Non-GAAP Financial Measures" and "Reconciliation of Non-GAAP Financials" below.

Third Quarter 2020 Business Highlights

·Expanded our differentiated Neurology menu to include tau phosphorylated at threonine 181 (p-tau181), a highly specific biomarker for the study of Alzheimer’s disease pathology, in cerebral spinal fluid (CSF), serum and plasma as well as launch of N4PE, containing four equally relevant biomarkers (NF-Light, GFAP, AB40, AB42) associated with many neurodegenerative diseases.

·Measuring the rate of change in patient Nfl levels allowed detection of familial Alzheimer’s more than 16 years before the onset of symptoms. This coupled with our recent launch of pTau-181, a highly specific biomarker for the study of Alzheimer’s disease pathology, brings us closer to the possibility of Alzheimer’s early disease detection, clinical trials subject stratification, patient triaging and asymptomatic screening.

·Entered into a non-exclusive royalty-bearing license agreement with Abbott Laboratories, to grant Abbott access to Quanterix’ portfolio of bead-based technology patents for use in in vitro diagnostic (IVD) applications.

·Awarded an $18.2M Phase 2 contract with the National Institutes of Health (NIH) through its Rapid Acceleration of Diagnostics (RADx) initiative to accelerate the continued development, scale-up and deployment of a novel SARS-CoV-2 antigen test based on Quanterix’ ultra-sensitive Simoa technology. Preliminary results indicate that the test has the potential to enable detection from a variety of sample types including self-collected capillary blood, saliva and nasal swabs.

·Continued to advance our relationship with one of the largest multi-national, healthcare payor groups, with start of multiple population surveillance studies and creating beachhead for our vision for future of precision medicine, where early and non-invasive disease detection has the potential to transform life and healthcare costs.

·We nce again participated in the Alzheimer’s Association International Conference (AAIC), with Simoa powering more than 50 posters and presentations on display during the virtual event. Among the session highlights was a presentation from Alector that outlined findings from its NFRONT Phase 1b/2 clinical study, which used Simoa to investigate the effect of AL001, an investigational therapeutic, on biomarker levels, including neurofilament light chain (Nf-L) associated with frontotemporal dementia (FTD).

·Amid ongoing discussion and research into the disease mechanisms behind COVID-19 ‘long-haulers,’ our technology continues to be instrumental in supporting routine, non-invasive testing necessary to study the long-term effects and complications of SARS-CoV-2. Research published in the Journal of Neurology was among the first to study neuronal injury in patients with mild-to-moderate COVID-19 by utilizing Simoa to measure serum neurofilament light (sNf-L). The study demonstrated the virus’ neuron-destructive capabilities in a cohort of 100 healthcare workers ages 18-65, establishing a rationale and foundation to support the study of neurological manifestations in mild-to-moderate COVID-19 cases.

·Continued to support the MS research community as a sponsor and participating organization for the 8th Joint ACTRIMS-ECTRIMS Meeting, MSVirtual2020. Simoa enabled more than 40 posters and presentations that validated the use of biomarkers, such as Nf-L, to distinguish MS from other neurodegenerative conditions, enhance monitoring strategies and inform improved treatment pathways.

·Quanterix’ Simoa technology was highlighted in a record 104 new publications, bringing total Simoa-specific inclusions to over 985.

Conference Call

In conjunction with this announcement, Quanterix Corporation will host a conference call on November 5 at 4:30 p.m., EDT. Individuals interested in listening to the conference call may do so by dialing (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following conference ID: 3039608.

A live webcast will also be available at: View Source

The webcast will be available on the Company’s website, View Source, for one year following completion of the call.

On November 5, 2020 Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, reported financial results for the third quarter ended September 30, 2020 and provided corporate updates (Press release, Arcus Biosciences, NOV 5, 2020, View Source [SID1234570074]).

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"Our progress in 2020 has significantly de-risked the viability of Arcus’s ambitions to become a long-term independent biopharmaceutical company." said Terry Rosen, Ph.D., CEO. "With the continued advancement of our four clinical-stage molecules, a landmark all-in collaboration with Gilead, a recently announced collaboration with AstraZeneca and approximately $785 million of cash on our balance sheet, we are well positioned to capitalize on the opportunities afforded by our pipeline. We expect 2021 to be a pivotal year for the company, with meaningful clinical readouts for all four of our clinical-stage molecules that should provide clear evidence of clinical benefit, as well as the start of a registrational trial that is designed to support the potential approval of both zimberelimab monotherapy and domvanalimab in combination with zimberelimab. In 2021, we also expect to further expand our clinical pipeline with IND filings in the second half of the year for our first two small molecules active against cancer cell-intrinsic targets."

Key Corporate Highlights

Commenced our 10-year partnership with Gilead to co-develop and co-commercialize next-generation cancer immunotherapies. The partnership was designed to allow Arcus to benefit from Gilead’s significant operational and financial resources while preserving Arcus’s ability to quickly generate and advance molecules into and through early clinical development. Since the partnership was announced, there has been tremendous collaboration between the two companies, particularly on the domvanalimab clinical program including in the recent execution of our collaboration with AstraZeneca. As part of the agreement, Gilead received immediate rights to co-develop and co-commercialize zimberelimab and an option to exclusively license investigational products from each of Arcus’s other current and future programs over the 10-year collaboration term. For each program, Arcus’s achievement of a designated development milestone will trigger an option window, and Gilead may exercise its option at any time up until the end of the option window, subject to certain exceptions.

Presented safety data and preliminary evidence of clinical activity from ARC-4, a Phase 1/1b study of etrumadenant plus carboplatin, pemetrexed and anti-PD-1 therapy in patients with metastatic non-small cell lung cancer, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 in September:

Demonstrated a favorable safety profile with early observations of clinical activity seen across multiple clinical settings, including responses in patients with prior immune checkpoint therapy and patients with EGFRmut tumors with recurrent disease.

Dosing continues in EGFRmut tyrosine kinase inhibitor (TKI)-relapsed and refractory patients, a setting which could provide a potential path for accelerated approval. A control arm of zimberelimab and chemotherapy has also been initiated.

Preparations underway for a registrational trial to support the potential approval of both zimberelimab monotherapy and domvanalimab in combination with zimberelimab in a single trial.

Anticipated Corporate Milestones

Fourth Quarter of 2020

Present preliminary biomarker data from the ARC-3 study evaluating etrumadenant plus mFOLFOX-6 in metastatic colorectal cancer (mCRC) at the Society for Immunotherapy Cancer’s (SITC) (Free SITC Whitepaper) Annual Meeting, November 9-14, 2020.

Present preliminary data from the ARC-2 study evaluating etrumadenant plus pegylated liposomal doxorubicin with or without eganelisib (IPI-549), a PI3K-gamma inhibitor, in gynecological cancers at the 2020 San Antonio Breast Cancer Symposium (SABCS) Annual Meeting, December 8-11, 2020.

File the IND for AB308, Arcus’s FcR-competent anti-TIGIT antibody. The activity of an FcR-competent antibody may be important for targeting specific cancer types, such as hematological malignancies. Initiation of Phase 1/1b dose escalation study to evaluate AB308 in combination with zimberelimab in hematological malignancies and solid tumors is expected in the first half of 2021.

Full Year 2021

Preliminary dose-escalation data from ARC-8, our Phase 1/1b study, evaluating AB680 in combination with zimberelimab and gemcitabine/nab-paclitaxel in first-line metastatic pancreatic cancer, are expected to be presented at the ASCO (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium, January 15-17, 2021. This represents the first disclosure of clinical data for our small molecule CD73 inhibitor. Based on the clinical activity observed to date, Arcus will open a randomized dose-expansion portion of this trial which will evaluate AB680 + zimberelimab + gemcitabine/nab-paclitaxel vs. AB680 + gemcitabine/nab-paclitaxel.

Preliminary data from ARC-7, our randomized, three-arm Phase 2 study evaluating zimberelimab vs. zimberelimab + domvanalimab, vs. zimberlimab + domvanalimab + etrumadenant in first-line patients with PD-L1>50% metastatic NSCLC is expected in the first half of 2021. The preliminary data are expected to be presented at a subsequent medical conference in 2021.

Preliminary randomized data from the Phase 2 portion of ARC-4, our ongoing trial evaluating etrumadenant + zimberelimab + chemotherapy vs. zimberelimab + chemotherapy in EGFRmut tyrosine

kinase inhibitor (TKI)-relapsed and refractory NSCLC, are expected to be presented at a medical conference in 2021.

Preliminary data from at least one cohort of ARC-6, our Phase 1b/2 platform study in metastatic castrate-resistant prostate cancer across multiple lines of therapy, evaluating etrumadenant-based combinations with zimberelimab in combination with standard of care therapies or with zimberelimab and/or AB680, are expected to be presented at a medical conference in 2021.

IND filings for two small molecule development candidates active against cancer cell-intrinsic targets are planned for the second half of 2021.

Initiate ARC-9, a randomized Phase 1b/2 platform study to evaluate etrumadenant in combination with other agents in 2L+ mCRC cohorts.

Appointed Jennifer Jarrett as Chief Operating Officer (COO) of the company. Ms. Jarrett previously served as Arcus’s CFO/COO and was instrumental in the Company’s early success, including having led the company’s IPO, and has maintained a close connection to Arcus’s strategy and operations during the intervening period as an ongoing board member.
Announced strategic collaboration with AstraZeneca to conduct PACIFIC-8, a registrational study, to evaluate domvanalimab, Arcus’s novel anti-TIGIT antibody, in combination with Imfinzi (durvalumab) in Stage III unresectable non-small cell lung cancer (NSCLC). Imfinzi is the only immunotherapy approved for this indication and this trial will evaluate a promising immunotherapy combination that has the potential to further enhance the efficacy and improvement of long-term survival that Imfinzi has already demonstrated in this setting. The study is expected to begin in 2021.

Financial Results for the Third Quarter 2020 Ended September 30, 2020

Cash, cash equivalents and investments were $785.1 million as of September 30, 2020, compared to $188.3 million at December 31, 2019. The increase was primarily due to net proceeds of $326.2 million from the May 2020 public equity offering and $375 million received upon closing of the Gilead agreements, partially offset by cash utilized for our operations. We expect cash, cash equivalents and marketable securities on-hand to be sufficient to fund operations into at least 2023.

Revenues: Collaboration and license revenues were $64.5 million for the three months ended September 30, 2020, compared to $1.8 million for the same period in 2019. The increase in revenues was primarily due to revenue recognized under the Gilead Collaboration Agreement for the license to zimberelimab and Gilead’s ongoing rights to access our research and development pipeline. Collaboration and license revenues were $68.0 million for the nine months ended September 30, 2020, compared to $5.3 million for the same period in 2019.

R&D Expenses: Research and development expenses were $51.8 million for the three months ended September 30, 2020, compared to $17.2 million for the same period in 2019. The increase was primarily due to increases in sublicense and milestone payments of $13.1 million in the 2020 period as compared to no amounts in the 2019 period, increases in manufacturing costs required to supply our clinical studies, increases in employee compensation costs, approximately $2.1 million of which consists of non-cash stock-based compensation, driven by an increase in our headcount, and increases in clinical costs for our ongoing clinical studies. Research and development expenses were $110.6 million for the nine months ended September 30, 2020, compared to $57.8 million for the same period in 2019.

G&A Expenses: General and administrative expenses were $11.2 million for the three months ended September 30, 2020, compared to $7.8 million for the same period in 2019. The increase in expense was due to increases in employee compensation, approximately $1.2 million of which consists of non-cash stock-based compensation costs, driven by an increase in headcount. Additional increases in legal and accounting expenses resulted from our collaboration agreement with Gilead and our ongoing public company compliance obligations. General and administrative expenses were $29.6 million for the nine months ended September 30, 2020, compared to $18.6 million for the same period in 2019.

Net Income: Net income was $1.8 million for the three months ended September 30, 2020, compared to a net loss of $22.4 million for the same period in the prior year. The net income as compared to the prior period’s net loss was primarily attributable to the revenue recognized under the Gilead agreements as noted above. Net loss for the nine months ended September 30, 2020 was $71.0 million, compared to $68.1 million for the same period in 2019.

On November 5, 2020 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody technology platform, reported third quarter 2020 financial results and provided a business update (Press release, CytomX Therapeutics, NOV 5, 2020, View Source [SID1234570073]).

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"As we approach the end of the year, the productivity of our R&D engine is evident with the growing breadth of our clinical pipeline, which is increasingly focused on previously undruggable targets. Between CytomX and our partners, there are now five Probody programs in the clinic, with four in Phase 2 studies, including CX-2029, for which we were excited to announce the treatment of the first patient in the expansion cohorts earlier today," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "So far this year, we have reported single agent anti-cancer activity for CX-072, CX-2009 and CX-2029, and we also are encouraged by the promising Phase 1 tolerability data reported by BMS for the anti-CTLA-4 Probody, BMS-986249. In addition, we continue to advance compelling preclinical candidates targeting EpCAM and EGFR-CD3 toward clinical development. Looking ahead to 2021, we believe we are well positioned for significant data updates from our robust clinical portfolio."

THIRD QUARTER BUSINESS HIGHLIGHTS AND RECENT DEVELOPMENTS

Clinical Pipeline Progress: Advancing into Multiple Phase 2 Expansion Cohorts

CX-2009: Phase 2 Expansion Studies in HER2 Negative Breast Cancer Subtypes in 2020

CytomX expects to initiate a redesigned, multi-arm Phase 2 study evaluating CX-2009, a first in class anti-CD166 Probody drug conjugate, in patients HER2 negative breast cancer, in the fourth quarter of 2020. CX-2009 is armed with the maytansinoid payload DM4.
This Phase 2 study is expected to be comprised of three arms. Arm A will enroll patients with hormone receptor (ER, PR) positive, HER2 non-amplified breast cancer for treatment with CX-2009 monotherapy (7mg/kg, q3w). Arm B will enroll patients with triple negative breast cancer (TNBC) for treatment with CX-2009 monotherapy (7mg/kg, q3w). Arm C will enroll patients with TNBC for treatment with CX-2009 monotherapy (7mg/kg q3w) in combination with CX-072 (pacmilimab, 1200mg q3w), the Company’s proprietary anti-PD-L1 Probody therapeutic candidate. Additional information is available at ClinicalTrials.gov using the identifier NCT04596150.
Data from the Phase 1 study of CX-2009 in patients with HER2 negative breast cancer were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program in May and will be updated at San Antonio Breast Cancer Conference later this year.
CX-2029: Initiation of Phase 2 Expansion Cohorts

Today, CytomX, in partnership with AbbVie, announced the treatment of the first patient in the Phase 2 expansion cohorts evaluating CX-2029, a first in class anti-CD71 Probody drug conjugate, as monotherapy in patients with head and neck squamous cell cancer (HNSCC), squamous non-small cell lung cancer (SqNSCLC), esophageal carcinoma, and diffuse large B cell lymphoma (DLBCL). Additional information is available at ClinicalTrials.gov using the identifier NCT03543813. CytomX anticipates initial data from this study in late 2021.
Preliminary clinical data from the first-in-human, Phase 1 dose escalation study of CX-2029 in patients with solid tumors was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program in May.
Updated data from an August 14, 2020 cutoff of this study is included below: (Figures 1 and 2). Of note:
12 patients with sqNSCLC or HNSCC were enrolled in the Phase 1 dose escalation
4 patients with sqNSCLC were enrolled into the 1, 3 or 5mg/kg cohorts of the study.
3 out of 4 patients had a best response of stable disease or better:
2 patients had confirmed partial responses with a duration of 2.5 months and 5.6 months, dosed at 5 and 3 mg/kg respectively.
1 patient with stable disease enrolled in the 3mg/kg cohort remained on treatment with stable disease for 26 weeks.
1 patient experienced disease progression at the first on-treatment assessment and was enrolled at the 1mg/kg dose level.
8 patients with HNSCC were enrolled into the 2 or 3mg/kg cohorts of the study.
7 out of 8 patients showed a best response of stable disease or better:
1 patient with a confirmed PR remains ongoing at 38 weeks on treatment, with target lesion reduction of greater than 80%.
1 patient with stable disease remains on treatment at 33 weeks.
The remaining patients have come off treatment for disease progression.
None of these 12 patients stopped treatment for a toxicity related issue.
The most commonly occurring Grade 3 or higher adverse event was anemia, occurring in 49% of 45 treated patients across all dose levels. No new safety signals were observed at the updated data cutoff.
BMS-986249: Anti-CTLA-4 Probody Immunotherapeutic

Bristol Myers Squibb continues to enroll patients as part of the Part 2a randomized cohort expansion of the ongoing Phase 1/2a trial of BMS-986249 administered in combination with nivolumab (Opdivo) in patients with metastatic melanoma. Additional information is available at ClinicalTrials.gov using the Identifier NCT03369223.
Bristol Myers Squibb presented safety data from the dose escalation stage of a Phase 1/2a trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program in May.
BMS-986288: Anti-CTLA-4 Non-Fucosylated Probody Immunotherapeutic

Bristol Myers Squibb continues to enroll patients as part of the Part 1 dose escalation study of the ongoing Phase 1/2a trial of BMS-986288 administered as monotherapy and in combination with nivolumab in patients with selected advanced solid tumors. Additional information is available at ClinicalTrials.gov using the Identifier NCT03994601.
Preclinical Pipeline

CX-2043 EpCAM Probody Drug Conjugate

In October, CytomX presented updated preclinical data at the 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium for CX-2043, a Probody Drug Conjugate targeting EpCAM (Epithelial Cell Adhesion Molecule), a widely expressed tumor antigen. CX-2043 is conjugated to the novel maytansinoid payload, DM-21. CX-2043 demonstrated potent anti-tumor activity across multiple cancer types and superior tolerability in animal models compared to the corresponding antibody drug conjugate. CytomX is advancing CX-2043 towards clinical studies with IND filing projected for late 2021.
CX-904 EGFR-CD3 Probody Bispecific

CytomX continued to advance CX-904, the lead candidate from the Epidermal Growth Factor Receptor-CD3 T-Cell Bispecific program, towards IND-enabling studies. CX-904 is partnered with Amgen as part of a global co-development agreement.
Third Quarter 2020 Financial Results

Cash, cash equivalents and short-term investments totaled $321.1 million as of September 30, 2020, compared to $296.1 million as of December 31, 2019.

Revenue was $17.8 million for the three months ended September 30, 2020, compared to $10.7 million for the three months ended September 30, 2019. The net increase in revenue of $7.1 million was primarily due to an increase of $2.6 million from AbbVie resulting from the recognition of the percentage of completion for the current quarter related to the $40.0 million milestone payment received in March 2020 under the CD71 Co-Development and Licensing Agreement, and an increase of $4.5 million consisting of the $4.0 million related to the recognition of revenue from the $80 million upfront payment, as well as $0.5 million in service revenue, under the Collaboration and License Agreement with Astellas entered into in March 2020.

Research and development expenses decreased by $3.9 million during the three months ended September 30, 2020 to $24.0 million compared to $28.0 million in the corresponding period in 2019. The decrease was largely attributed to a decrease in clinical trial activities primarily due to the COVID-19 pandemic.

General and administrative expenses were essentially flat during the three months ended September 30, 2020, amounting to $8.6 million compared to $8.5 million in the corresponding period in 2019.

Teleconference Scheduled Today at 5:00 p.m. ET (2:00 p.m. PT)

Conference Call & Webcast Information

CytomX management will host a conference call today at 5:00 p.m. ET (2:00 p.m. PT). Interested parties may access the live audio webcast of the teleconference through the "Investor & News" section of CytomX’s website at View Source or by dialing 1-877-809-6037 (U.S. and Canada) or 1-615-247-0221 (International) and using the passcode 6705899. An archive of the webcast will be available on the CytomX website from November 5, 2020, until November 12, 2020.