On November 5, 2019 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, reported a corporate and financial update for the third quarter ended September 30, 2019 (Press release, G1 Therapeutics, NOV 5, 2019, View Source [SID1234550325]).

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"Based on written feedback from the FDA following our pre-NDA meeting in September, we will submit a New Drug Application for myelopreservation in small cell lung cancer. We expect to complete the submission in the second quarter of 2020," said Mark Velleca, M.D., Ph.D., Chief Executive Officer. "Our vision is for trilaciclib to become a new standard of care to mitigate myelosuppression in patients receiving chemotherapy. We are committed to making trilaciclib available to small cell lung cancer patients as quickly as possible, and are executing on a regulatory and development strategy to evaluate the myelopreservation benefits of trilaciclib in the most commonly used chemotherapy regimens. We expect to initiate a Phase 3 trial in colorectal cancer in the second half of 2020. In addition, we will continue to explore trilaciclib in triple-negative breast cancer, where preliminary data has demonstrated a survival benefit."

Third Quarter Regulatory and Clinical Highlights

The company plans to submit an NDA for trilaciclib in small cell lung cancer (SCLC) based on written feedback from FDA. Based on written feedback from its pre-NDA meeting with the U.S. Food and Drug Administration (FDA) in September, the company will file an NDA for trilaciclib in SCLC. The company expects to complete the NDA submission in the second quarter of 2020. Earlier this year, trilaciclib received Breakthrough Therapy Designation (BTD) from the FDA based on positive myelopreservation data in SCLC patients from three randomized Phase 2 clinical trials. The BTD program is designed to expedite development and review of drugs intended for serious or life-threatening conditions.

ESMO presentations: data from Phase 2 clinical trials of trilaciclib in metastatic triple-negative breast cancer (mTNBC) and SCLC and data from Phase 1 clinical trial of G1T48 in ER+, HER2- breast cancer. In an oral presentation on data from a randomized Phase 2 trial of trilaciclib, preliminary overall survival (OS) results demonstrated that women with mTNBC lived significantly longer when receiving trilaciclib and chemotherapy compared with women receiving chemotherapy alone. Data were published simultaneously in The Lancet Oncology. The company also presented updated Phase 2 results in SCLC patients receiving trilaciclib and chemotherapy in combination with Tecentriq (atezolizumab) (press release here) and the first clinical data on its oral selective estrogen receptor degrader (SERD), G1T48. Preliminary results from the ongoing Phase 1/2a dose-escalation trial of G1T48 in patients with estrogen receptor- positive, HER2-negative (ER+, HER2-) breast cancer showed G1T48 was well tolerated and demonstrated evidence of anti-tumor activity in heavily pre-treated patients. Based on safety and tolerability findings in the Phase 1b portion of this trial, the company selected the 600 mg and 1,000 mg doses of G1T48 for evaluation in the ongoing Phase 2a portion (press release here).

Third Quarter 2019 Financial Highlights

Cash Position: Cash, cash equivalents and short-term investments totaled $299.9 million as of September 30, 2019, compared to $369.3 million as of December 31, 2018.

Operating Expenses: Operating expenses were $34.0 million for the third quarter of 2019, compared to $20.8 million for the third quarter of 2018. GAAP operating expenses include stock-based compensation expense of $4.4 million for the third quarter of 2019, compared to $3.3 million for the third quarter of 2018.

Research and Development Expenses: Research and development (R&D) expenses for the third quarter of 2019 were $22.9 million, compared to $15.9 million for the third quarter of 2018. The increase in R&D expense was primarily due to an increase in clinical program costs, costs for manufacturing pharmaceutical active ingredients, and personnel costs due to additional headcount.

General and Administrative Expenses: General and administrative (G&A) expenses for the third quarter of 2019 were $11.1 million, compared to $4.9 million for the third quarter of 2018. The increase in G&A expense was largely due to an increase in compensation due to additional headcount, increase in pre-commercialization activities, increase in medical affairs costs, and an increase in professional fees and other administrative costs necessary to support our operations.

Net Loss: G1 reported a net loss of $32.4 million for the third quarter of 2019, compared to $19.9 million for the third quarter of 2018.

2019 Guidance: The company expects to end the year with $265-$270 million in cash and cash equivalents.

Anticipated Milestones

Begin rolling NDA submission for trilaciclib in SCLC in 4Q19, which the company expects to complete in 2Q20; submit Marketing Authorization Application to the European Medicines Agency in 2H20.

Initiate clinical trials of trilaciclib in colorectal cancer and TNBC in 2020.

Present additional data from the Phase 1b/2a clinical trial of lerociclib + Faslodex (fulvestrant) at the 2019 San Antonio Breast Cancer Symposium (SABCS) on December 11, 2019.

Identify dose and schedule of lerociclib and G1T48 for pivotal trials in ER+, HER2- breast cancer.

Webcast and Conference Call

The management team will host a webcast and conference call at 4:30 p.m. ET today to provide a corporate and financial update for the third quarter 2019 ended September 30, 2019. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 3374256. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

On November 5, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that the company will host a conference call and webcast on Friday, November 8, 2019 at 8:00 a.m. ET to report its third quarter 2019 financial results and other business highlights (Press release, Stemline Therapeutics, NOV 5, 2019, https://ir.stemline.com/news-releases/news-release-details/stemline-therapeutics-host-conference-call-third-quarter-2019 [SID1234550341]).

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The conference call can be accessed by dialing 1-800-367-2403 (domestic) or 1-334-777-6978 (international) and referring to conference ID 9176352. The webcast can be accessed via the company’s website (www.stemline.com), at the bottom of the "Investors & Media" section in the "News & Events" page, and will be available live and for replay shortly after the event.

About ELZONRIS
ELZONRIS (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.

On November 5, 2019 OncoSec Medical Incorporated ("OncoSec") (Nasdaq:ONCS), a company developing late-stage intratumoral cancer immunotherapies, reported it will present a poster highlighting a safety and biomarker analysis on its lead product candidate, TAVO, at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting being held November 6-10, 2019 in National Harbor, Maryland (Press release, OncoSec Medical, NOV 5, 2019, View Source [SID1234550357]).

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The poster, titled "Intratumoral IL-12 plus pembrolizumab combination therapy in treatment refractory solid tumors: a safety and biomarker analysis," will be presented by author Alain Algazi, MD on Saturday, November 9th from 12:35 p.m. – 2:05 p.m. and from 7:00 p.m. – 8:30 p.m. Eastern Time.

The SITC (Free SITC Whitepaper) abstract titles are listed on the conference website under Abstracts at View Source

On November 5, 2019 QIAGEN (NYSE:QGEN; Frankfurt Prime Standard:QIA) reported a series of agreements that expand its immuno-oncology assets for future commercialization of novel companion diagnostics for precision medicine in immuno-oncology, in particular based on the powerful next-generation sequencing (NGS) technology (Press release, Qiagen, NOV 5, 2019, View Source [SID1234550373]).

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The agreements include a new collaboration with the Japanese company Repertoire Genesis Inc., which will provide access to novel technologies for the development of T-cell / B-cell receptor repertoire assays for use on NGS systems. QIAGEN intends to highlight these new agreements and other elements of its oncology portfolio at the Association for Molecular Pathology (AMP) Annual Meeting, which is being held from November 7-9 in Baltimore, Maryland.

Additionally, QIAGEN has entered into a new licensing agreement with researchers at the University of Bonn in Germany for novel epigenomic biomarkers based on immune checkpoint gene methylation, including CTLA4, PD-L1 and PD1, with rights to co-develop predictive companion diagnostics. In a second licensing agreement, QIAGEN has gained exclusive access to biomarker intellectual property held by the German diagnostic company STRATIFYER Molecular Pathology GmbH that is intended to provide guidance for treatment decisions in bladder cancer.

This series of agreements comes after QIAGEN recently entered into an agreement with Illumina Inc. to accelerate the adoption of NGS in clinical decision-making. QIAGEN has non-exclusive rights to develop and globally commercialize companion diagnostics and other IVD kits to be used together with Illumina’s MiSeq Dx and NextSeq 550Dx Systems. The agreement also includes rights for expansion of the partnership on future Illumina diagnostic (Dx) systems. The partnership will initially focus on commercializing oncology IVD kits to support patient management and may expand in the future to include additional clinical diagnostic fields, such as cardiology, hereditary diseases, infectious diseases, as well as inflammatory and autoimmune diseases.

On November 5, 2019 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer therapies, reported financial results for the third quarter ended September 30, 2019 and provided corporate updates (Press release, Arcus Biosciences, NOV 5, 2019, View Source [SID1234550310]).

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"Arcus is at an exciting and important point of inflection in its evolution," said Terry Rosen, Ph.D., Chief Executive Officer. "We are now advancing our clinical-stage molecules into efficacy evaluation studies, with data expected starting in mid-2020. At the 2019 ESMO (Free ESMO Whitepaper) Congress, we presented safety, pharmacokinetic and preliminary clinical activity data for AB928 across multiple combination regimens and in a variety of advanced tumor types. With these results and our expanding clinical development program, Arcus continues to mature on the path to becoming a fully integrated biopharmaceutical company."

Recent Corporate Highlights

Appointed Antoni (Toni) Ribas, M.D., Ph.D., to the company’s Board of Directors. Dr. Ribas is currently the President-Elect for the American Association for Cancer Research (AACR) (Free AACR Whitepaper) and is an internationally recognized physician-scientist. Dr. Ribas has been instrumental in transforming the treatment paradigm for oncology patients, serving as principal investigator for multiple trials, including several involving the breakthrough cancer therapy, Keytruda.

Selected 150 mg of AB928 as the recommended once-daily dose for expansion combination regimens across the AB928 program (four different combination backbones).

Presented updated data from the Phase 1 safety dose-escalation portion of the AB928 combination trials, which included 40 patients across the four trials, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. As of the data cut-off (DCO) of September 6, 2019:

Patients across all four clinical trials had very advanced, late-line metastatic disease, with a median of 3 to 4 prior lines of therapy.

50% of eligible study patients had received, and progressed on prior immunotherapies (e.g., anti-PD(L)-1 and/or anti-CTLA4 antibodies).

AB928 exhibits a favorable safety profile across multiple combination regimens, with no AB928-related Grade 4 or 5 adverse events.

The pharmacokinetic (PK) and pharmacodynamic (PD) profiles of AB928 in cancer patients are similar to those previously characterized in healthy volunteers.

Clinical activity, including five partial responses and disease stabilization beyond 6 months, was demonstrated across the four AB928 safety dose-escalation combination studies, with an overall

disease control rate of 43%, supporting further evaluation in ongoing and planned Phase 1b expansion trials.

Extensive biomarker characterization of patient tissue and blood samples across the AB928 program is ongoing.

Began enrolling in the Phase 1 safety dose-escalation trial for AB928 in combination with pegylated liposomal doxorubicin (PLD) and IPI-549, a PI3Kγ inhibitor, in collaboration with Infinity Pharmaceuticals.

Began recruiting in the biomarker-selected tumor-agnostic Phase 1b trial for AB122, an anti-PD-1 antibody, in collaboration with Strata Oncology.

Initiated Phase 1 first-line pancreatic safety dose-escalation trial for AB680, the first small-molecule CD73 inhibitor to enter the clinic.

Upcoming Milestones & Presentations

Anticipated Upcoming Milestones

Phase 1b expansion data from the ongoing AB928 trials starting in mid-2020. In addition to ongoing recruitment into the Phase 1b expansion in 2L+ prostate cancer in combination with AB122, the Company anticipates initiating a Phase 1b/2 prostate cancer platform trial in early 2020 to investigate earlier lines of therapy in combination with standard of care agents.

Phase 1b expansion data from the single-agent AB122 biomarker-selected tumor-type agnostic trial being conducted in collaboration with Strata Oncology, starting in mid-2020.

Safety dose-escalation data from the ongoing trial investigating AB154 in combination with AB122, in mid-2020. In addition, the Company anticipates initiating a Phase 2 trial, to investigate AB154 in combination with AB122 in patients with non-small cell lung cancer, in early 2020.

Safety dose-escalation data from the trial investigating AB680 in combination with AB122 and gemcitabine/nab-paclitaxel in patients with first-line metastatic pancreatic cancer starting in mid-2020.

Selection of a potentially best-in-class clinical development candidate from the Company’s discovery program targeting HIF-2α at the end of 2019/early 2020.

Upcoming Presentations

34th Annual Meeting of the Society for Immuno-Therapy of Cancer (SITC) (Free SITC Whitepaper); National Harbor, MD; November 6-10, 2019. At SITC (Free SITC Whitepaper), the Arcus Research team is presenting data, corresponding to the following abstracts, that: demonstrate the importance of the A2b receptor in adenosine-mediated tumor immunosuppression, support the rationale for development of CD73 inhibitors in gastrointestinal cancers, and provide an overview of the pharmacokinetic and pharmacodynamic properties of AB154.

Abstract Number P557: A2bR contributes to adenosine-mediated immunosuppression, which is relieved by the dual A2aR/A2bR antagonist AB928.

Abstract Number P379: Phase 1 Safety Study in healthy volunteers of AB680, a small-molecule inhibitor of CD73 and rationale for combination therapy in patients with gastrointestinal malignancies.

Abstract Number P260: Characterization of AB154, a humanized, non-depleting α-TIGIT antibody undergoing clinical evaluation in subjects with advanced solid tumors.

AACR Tumor Immunology & Immunotherapy Symposium; Boston, MA; November 17-20, 2019.

Abstract titled: CD73 Inhibition enhances the effect of anti-PD-1 therapy on KRAS mutated pancreatic cancer model.

Please refer to Arcus’s pipeline at www.arcusbio.com for the company’s most current pipeline and development plans.

Financial Results for the Third Quarter and Nine Months Ended September 30, 2019

Cash, cash equivalents and investments were $197.0 million, as of September 30, 2019, compared to $224.4 million at June 30, 2019. The decrease was primarily due to the utilization of cash to fund our operations. Based on our current operating plans, we anticipate that our cash, cash equivalents and investments will be sufficient to fund operations into 2021.

Revenues: Collaboration and license revenue for the third quarter of 2019 was $1.8 million, compared to $4.3 million for the same period in 2018. The decrease in revenue was due to Taiho Pharmaceutical’s exercise of a development and commercialization option in Japan and certain other Asian territories (excluding China) to our A2R program in 2018 that resulted in recognition of $3.0 million of revenue during the third quarter of 2018, partially offset by an increase in revenue recognized during the third quarter of 2019, related to our Taiho collaboration and license agreement, resulting from our adoption in 2019 of Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (ASC 606). Collaboration and license revenue for the nine months ended September 30, 2019 was $5.3 million, compared to $6.8 million for the same period in 2018.

R&D Expenses: Research and development expenses for the third quarter of 2019 were $17.2 million, compared to $12.9 million for the same period in 2018. The increase in research and development expenses was primarily due to an increase in clinical activities for our ongoing clinical programs and an increase in R&D headcount and related costs. Research and development expenses for the nine months ended September 30, 2019 were $57.8 million, compared to $38.2 million for the same period in 2018.

G&A Expenses: General and administrative expenses for the third quarter of 2019 were $7.8 million, compared to $3.6 million for the same period in 2018. The increase in general and administrative expenses were primarily due to an increase in G&A headcount and related costs, as well as additional compliance costs related to operations as a public company. General and administrative expenses for the nine months ended September 30, 2019 were $18.6 million, compared to $10.0 million for the same period in 2018.

Net Loss: Net loss for the third quarter of 2019 was $22.4 million, compared to $10.8 million for the same period in 2018. The increase in net loss as compared to the prior period was primarily attributable to an increase in operating expenses and a decrease in revenue as noted above. Net loss for the nine months ended September 30, 2019 was $68.1 million, compared to $37.3 million for the same period in 2018.