On November 5, 2020 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, reported its third-quarter 2020 financial results and corporate highlights (Press release, Kezar Life Sciences, NOV 5, 2020, View Source [SID1234570063]).

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"The third quarter of 2020 saw continued momentum for Kezar, punctuated by the U.S. FDA granting Orphan Drug Designations for our lead candidate KZR-616 for the treatment of polymyositis and dermatomyositis," said John Fowler, Kezar’s Co-Founder and Chief Executive Officer. "In addition, our presentations at a number of medical and scientific meetings this fall highlight the compelling therapeutic potential of our two highly novel programs in immunoproteasome inhibition and the protein secretion pathway. With each step forward, our conviction deepens that Kezar’s novel small molecule approaches in autoimmunity and oncology could have profound impacts on a wide array of diseases with high unmet need."

Clinical Highlights & Updates

KZR-616: Selective Immunoproteasome Inhibitor

KZR-616 is currently being evaluated for the treatment of severe autoimmune diseases.

In October 2020, Orphan Drug Designations (ODD) were granted for KZR-616 in both dermatomyositis (DM) and polymyositis (PM) by the U.S. Food and Drug Administration (FDA). Both orphan diseases are autoimmune inflammatory myopathies that are chronic and debilitating diseases characterized by marked morbidity and mortality. The estimated prevalence of DM and PM in the United States is up to 71,000 and 51,000, respectively. Orphan Drug Designation can provide certain benefits for the development of KZR-616, including a period of marketing exclusivity for the first marketing application, if approved for the designated indication, certain tax credits and waiver of certain administrative fees.
The MISSION Phase 2 trial in patients with active, proliferative lupus nephritis (LN) opened for enrollment under a new protocol in August 2020. The primary efficacy endpoint for the trial is the number of patients achieving a renal response measured by a 50% or greater reduction in urine protein to creatinine ratio (UPCR) at six months.
Interim data are expected in late 2021, and topline data are expected in the first half of 2022. To allow for responding patients to continue treatment with KZR-616, a 12-month extension study will also be made available.
Updated results from the MISSION Phase 1b portion were presented at the American College of Rheumatology Annual Meeting (ACR Convergence 2020) in November 2020. These results indicate that KZR-616 60mg administrated subcutaneously weekly is well-positioned for development as a long-term treatment option in autoimmune disease.
The PRESIDIO Phase 2 trial of KZR-616 in polymyositis (PM) and dermatomyositis (DM) continues to enroll. A 12-month open-label extension study has been initiated for patients completing the placebo-controlled trial.
Topline data are expected in the first half of 2022.
Pre-clinical results of KZR-616 in a murine model of polymyositis were presented during ACR Convergence 2020. The results provide a rationale for targeting selective immunoproteasome inhibition for the treatment of polymyositis.
KZR-261: Protein Secretion Program

KZR-261, a first-in-class protein secretion inhibitor, targets the Sec61 translocon and has demonstrated broad anti-tumor activity in preclinical models of both solid and hematologic malignancies. Additional preclinical data further detailing the ability of novel small molecule Sec61 inhibitors to target multiple checkpoint proteins on various cell populations, thereby offering the potential of combination therapy in a single compound, are being presented during the 8th Annual Meeting of the International Cytokine & Interferon Society (Cytokines 2020) and the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November 2020.
An Investigational New Drug (IND) application for KZR-261 is on-track for a planned submission in the first quarter of 2021. The Phase 1 clinical trial will evaluate dose escalation and safety and tolerability in patients with solid tumors to begin shortly after IND acceptance.
Third-Quarter 2020 Financial Results

Cash, cash equivalents and marketable securities totaled $150.0 million as of September 30, 2020, compared to $78.2 million as of December 31, 2019. The increase in cash, cash equivalents and marketable securities was primarily attributable to the net proceeds from Kezar’s underwritten public offerings in February and June 2020, net of cash used by the Company in operations to advance its clinical stage programs and preclinical research and development.
Research and development expenses for the third quarter of 2020 increased by $1.2 million to $8.3 million, compared to $7.1 million in the third quarter of 2019. This increase was primarily related to advancing both the KZR-616 clinical program in multiple indications and the protein secretion preclinical program.
General and administrative expenses for the third quarter of 2020 increased by $0.7 million to $3.3 million, compared to $2.6 million in the third quarter of 2019. The increase was primarily due to an increase in personnel expenses, including non-cash stock-based compensation, legal and professional fees.
Net loss for the third quarter of 2020 was $11.3 million, or $0.23 per basic and diluted common share, compared to a net loss of $9.1 million, or $0.48 per basic and diluted common share, for the third quarter of 2019.
Total shares of common stock outstanding were 46.3 million as of September 30, 2020. Additionally, there were outstanding pre-funded warrants to purchase 3.8 million shares of common stock at an exercise price of $0.001 per share and outstanding options to purchase 4.5 million shares of common stock at a weighted average exercise price of $6.12 per share as of September 30, 2020.
About KZR-616

KZR-616 is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Data generated from Phase 1a and 1b clinical trials provide evidence that KZR-616 exhibits a favorable safety and tolerability profile for development in severe, chronic autoimmune diseases. Phase 2 trials are underway in severe autoimmune diseases.

About KZR-261

KZR-261, a novel, first-in-class protein secretion inhibitor, is the first clinical candidate to be nominated from Kezar’s research and discovery efforts targeting protein secretion pathways. KZR-261 is a broad-spectrum anti-tumor agent that acts through direct interaction and inhibition of Sec61 activity. The compound was discovered by Kezar through a robust medicinal chemistry campaign in which several scaffolds were progressed through the company’s proprietary platform evaluating Sec61 modulation. As a result, Kezar has established a broad library of protein secretion inhibitors. KZR-261 has demonstrated several encouraging properties that lead to its potential to be an anti-cancer agent for the treatment of solid and hematologic malignancies. IND-enabling activities are currently underway, and an IND submission in solid tumors is expected to be filed in the first quarter of 2021.

On November 5, 2020 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel, small-molecule drugs for the treatment of cancer and other life-threatening diseases, reported its financial results for the third quarter ended September 30, 2020 (Press release, Calithera Biosciences, NOV 5, 2020, View Source [SID1234570062]).

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"To date, 2020 has been a significant year for Calithera as we’ve made remarkable progress to advance our clinical development efforts across our pipeline and work toward reporting our first pivotal trial results with our lead candidate glutaminase inhibitor telaglenastat, while continuing to strengthen our cash position," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "We look forward to reporting top-line results from our pivotal CANTATA trial evaluating telaglenastat in renal cell carcinoma in late fourth quarter of 2020 or early first quarter 2021. We also announced recently the initiation of the first clinical trial to evaluate our novel arginase inhibitor in cystic fibrosis, and the initiation of our first clinical trial evaluating telaglenastat in people with non-small cell lung cancer whose tumors have KEAP1 or NRF2 genetic mutations."

Third Quarter 2020 and Other Recent Program Highlights

Progress continues toward top-line data readout of pivotal Phase 3 CANTATA randomized trial of telaglenastat and cabozantinib in advanced renal cell carcinoma (RCC). The CANTATA trial is a global, randomized, double-blind clinical trial of telaglenastat combined with cabozantinib, in patients with advanced or metastatic RCC who have received one or two prior treatments. The trial enrolled 444 patients at multiple centers globally. The primary endpoint is progression-free survival (PFS). Calithera expects to report top-line efficacy and safety data from the trial in late fourth quarter of 2020 or early first quarter 2021.
KEAPSAKE randomized trial evaluating telaglenastat in non-small cell lung cancer (NSCLC) patients with a KEAP1 or NRF2 genetic mutation enrolled first patient in September. Mutations in the KEAP1/NRF2 pathway, which occur in an estimated 20 percent of NSCLC patients, are associated with aggressive tumor growth and poor outcomes for patients. The double-blind KEAPSAKE trial will enroll approximately 120 patients with stage IV non-squamous NSCLC with tumors that have the KEAP1 or NRF2 mutation. Patients will be randomized to receive telaglenastat or placebo, in combination with pembrolizumab, carboplatin and pemetrexed. The study will evaluate the safety and investigator-assessed PFS of telaglenastat plus this standard-of-care chemo-immunotherapy regimen. Calithera anticipates sharing interim data from the KEAPSAKE trial in 2021.
ENTRATA Phase 2 study of telaglenastat with everolimus in RCC survival analysis completed. The ENTRATA trial was a randomized, double-blind, trial designed to evaluate the safety and efficacy of telaglenastat in combination with everolimus versus placebo with everolimus in patients with advanced clear cell RCC who have been treated with at least two prior lines of systemic therapy, including at least one prior VEGFR-targeted tyrosine kinase inhibitor. The trial enrolled 69 patients. The primary endpoint was PFS per investigator assessment with a predetermined threshold of p≤0.2 one-sided. Top-line results were reported in June 2019. Telaglenastat, when added to everolimus, doubled the median PFS in heavily pretreated patients with advanced RCC to 3.8 months as compared to 1.9 months for everolimus alone, and reduced the risk of disease progression or death by 36% (HR=0.64, p=0.079 one-sided). Although the study was not powered for survival, it was evaluated as a secondary endpoint, and is now mature enough to be reported. Based on the data cutoff of September 30, 2020, the median overall survival is 14.4 months vs. 9.7 months in the telaglenastat and control arms, respectively (HR=0.80, p=0.24 one-sided).
Pfizer clinical collaboration investigating the CDK4/6 inhibitor IBRANCE with telaglenastat expanded to evaluate the combination in pancreatic cancer patients. In July 2019, Calithera initiated a Phase 1/2 trial of the combination of telaglenastat plus Ibrance in patients with solid tumors including expansion cohorts in KRAS-mutated colorectal cancer and KRAS-mutated non-small cell lung cancer. In November, Calithera announced the expansion of this collaboration to include an additional cohort of patients with pancreatic ductal adenocarcinoma (PDAC) whose tumors harbor mutations in both KRAS and CDKN2A.
CB-280 arginase inhibitor program advanced. In October, Calithera presented a trial in progress poster at the North American Cystic Fibrosis 2020 Virtual Conference. The presentation included preclinical study results which suggest CB-280 significantly improved lung function and reduced Pseudomonas aeruginosa colony-forming units in pre-clinical models. Arginase inhibition with CB-280 resulted in improved central airway resistance in CFTR knockout mice, and decreased lung infection in wild type and DeltaF508-CFTR-expressing mice infected with Pseudomonas aeruginosa. Enrollment in the Ph1b study is ongoing and Calithera expects to share interim data in 2021. In November, Calithera was awarded up to $2.4M from the Cystic Fibrosis Foundation to support clinical development of CB-280.
INCB001158 program continued progress. INCB001158, an internally discovered molecule, is being evaluated in multiple clinical trials for the treatment of patients with solid tumors both as a monotherapy, in combination with anti-PD-1 immunotherapy, and in multiple chemotherapy regimens. While Calithera remains committed to and confident in the INCB001158 development program, Calithera decided to opt out of co-development obligations with Incyte in order to focus resources on internal development programs.
Preclinical data presented from CB-668 IL4I1 program. CB-668 is an investigational first-in-class, potent, orally administered IL4I1 inhibitor as a novel immuno-oncology approach to cancer. New preclinical data for CB-668 will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Virtual Meeting November 11-14, 2020.
Selected Third Quarter 2020 Financial Results

Cash, cash equivalents and investments totaled $137.7 million at September 30, 2020.

Research and development expenses were $18.2 million for the three months ended September 30, 2020, compared to $17.2 million for the same period in the prior year. The increase of $1.0 million was due to a $1.9 million increase in the telaglenastat program and a $1.5 million increase in the CB-280 program, partially offset by a $1.0 million decrease in the INCB001158 program and a decrease of $1.4 million in early stage research.

General and administrative expenses were $4.7 million for the three months ended September 30, 2020, compared with $3.9 million for the same period in the prior year. The increase of $0.8 million was primarily related to an increase in higher personnel-related and facility costs.

Interest and other income, net was $0.2 million for the three months ended September 30, 2020, compared to $0.8 million for the same period in the prior year, mainly as a result of lower interest rates.

Net loss for the three months ended September 30, 2020 was $22.7 million, or $0.32 per share.

Conference Call Information

Calithera will host an update conference call today, Thursday, November 5, at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. The call may be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 and referring to conference ID 6869011. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at View Source The webcast will be recorded and available for replay on Calithera’s website for 30 days.

On November 5, 2020 FibroGen, Inc. (NASDAQ:FGEN) reported financial results for the third quarter of 2020 and provided an update on the company’s recent developments (Press release, FibroGen, NOV 5, 2020, View Source [SID1234570061]).

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"I am pleased with our progress with roxadustat across a number of fronts; including engagement with the FDA, commercial preparations in the U.S., and our impressive sales results in China." said Enrique Conterno, Chief Executive Officer, FibroGen. "As the world navigates the effects of the COVID-19 pandemic, we continue to advance our roxadustat and pamrevlumab clinical programs."

Key Events in Recent Months and Other Developments

Roxadustat

FibroGen and its partners presented 42 abstracts, including 10 oral presentations and 2 late-breaker poster presentations, at the recent American Society of Nephrology (ASN) Kidney Week 2020 Reimagined conference:
• Two late-breaking abstracts explored the cardiovascular outcomes of patients with anemia of chronic kidney disease (CKD) treated with roxadustat, including associations between achieved hemoglobin levels and risk of Major Adverse Cardiovascular Events (MACE) and MACE+.
• New analyses showed the efficacy of roxadustat across the continuum of patients with anemia of CKD – both on dialysis and not on dialysis – including different dialysis modalities, iron repletion status, and comorbidities.
• Presentations addressed the safety profile of roxadustat related to neoplasms, hypertension, and ophthalmological effects.
• Additional presentations explored the increased risk of red blood cell transfusion at lower hemoglobin levels and the impact of roxadustat on rates of hospitalization due to heart failure.
U.S. NDA for roxadustat for the treatment of anemia of chronic kidney disease, in dialysis-dependent and non-dialysis-dependent patients, is under review with a Prescription Drug User Fee Act (PDUFA) date of December 20, 2020.
Marketing authorization application (MAA) for roxadustat for the treatment of anemia in adult patients with CKD, both on dialysis and not on dialysis, is under review by the European Medicines Agency (EMA).
Japan sNDA for roxadustat for the treatment of anemia of CKD in non-dialysis-dependent patients is under review by the Pharmaceuticals and Medical Devices Agency (PMDA).
Continued enrollment of the Phase 3 roxadustat clinical trial in anemia associated with myelodysplastic syndromes (MDS) and Phase 2 roxadustat clinical trial in chemotherapy-induced anemia (CIA).
Pamrevlumab

Initiated LELANTOS, a Phase 3 trial of pamrevlumab in patients with non-ambulatory Duchenne muscular dystrophy (DMD).
Continued enrollment of the ZEPHYRUS Phase 3 clinical trial of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF).
Continued enrollment of the LAPIS Phase 3 clinical trial of pamrevlumab in patients with locally advanced unresectable pancreatic cancer (LAPC).
Upcoming Events

Plan to initiate ZEPHYRUS-2, a Phase 3 trial of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF) as COVID-19 conditions improve.
Plan to initiate LELANTOS-2, a Phase 3 trial of pamrevlumab in patients with ambulatory Duchenne muscular dystrophy (DMD) by year-end.
Corporate and Financial

Total revenue for the third quarter of 2020 was $44.0 million, as compared to $33.2 million for the third quarter of 2019. The current quarter revenue consisted of $22.7 million in net roxadustat sales in China, $20.7 million in development revenue, $2.3 million for sales of bulk drug product, and a net reduction of $1.7 million for certain adjustments.
Net income for the third quarter of 2020 was $33.0 million, or $0.36 net income per basic and $0.35 per diluted share, compared to a net loss of $49.4 million, or $0.57 net loss per basic and diluted share one year ago.
Amended China Agreement with AstraZeneca in July 2020 such that both parties are optimally aligned to maximize the economic value of the roxadustat franchise, with more predictable economics and profitability for FibroGen. As a result, we reversed approximately $84.4 million of co-promotion expenses as a reduction to selling, general and administrative expenses in the third quarter of 2020.
At September 30, 2020, FibroGen had $719.3 million in cash, cash equivalents, restricted time deposits, investments, and receivables.
Based on our latest forecast, we now estimate our year-end 2020 balance for cash, cash equivalents, restricted time deposits, investments, and receivables to be in the range of $770 to $780 million.
Appointed Percy Carter, MBA, PhD, to the newly-created position of Chief Scientific Officer.
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Thursday, November 5, 2020, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (877) 658-9081 (U.S. and Canada) or 1 (602) 563-8732 (international), reference the FibroGen third quarter 2020 financial results conference call, and use passcode 5994243. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and use passcode 5994243.

About Roxadustat
Roxadustat is a first-in-class, oral small molecule HIF-PH inhibitor that promotes erythropoiesis through increased endogenous production of erythropoietin; improved iron absorption, transport, and mobilization; and downregulation of hepcidin, which helps to overcome the negative impact of inflammation on hemoglobin synthesis and red blood cell production. Roxadustat is approved in China for the treatment of anemia of adult patients with CKD, both on dialysis and not on dialysis. In Japan, roxadustat is approved for the treatment of anemia of CKD patients on dialysis, and a supplemental NDA for the treatment of anemia of CKD patients not on dialysis is under regulatory review. The roxadustat NDA for the treatment of anemia of CKD in patients both on dialysis and not on dialysis is under review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Act date of December 20, 2020. The Marketing Authorization Application for roxadustat for the treatment of anemia of CKD in patients both on dialysis and not on dialysis was filed by our partner Astellas and accepted by the European Medicines Agency for review on May 21, 2020. Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and chemotherapy-induced anemia (CIA).

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa. AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in the U.S., China, and other markets in the Americas and in Australia/New Zealand, as well as Southeast Asia.

About Pamrevlumab
Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and locally advanced unresectable pancreatic cancer (LAPC), and Duchenne muscular dystrophy (DMD); and in Phase 2 clinical development for the treatment of coronavirus (COVID-19). For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

On November 5, 2020 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported financial results for the quarter ended September 30, 2020 (Press release, ORIC Pharmaceuticals, NOV 5, 2020, View Source [SID1234570060]).

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"In just over six months since our initial public offering we have made substantial progress in advancing our internally developed pipeline and also successfully executed two highly strategic business development deals to augment our pipeline with additional novel programs," said Jacob Chacko, M.D., president and chief executive officer. "These efforts have put us in position for multiple upcoming milestones in 2021, including two top line interim Phase 1b clinical readouts for our lead program, ORIC-101, as well as three IND/CTA filings for ORIC-533, -944 and -114."

Third Quarter 2020 and Other Recent Highlights

Licensed Exclusive Rights to EGFR/HER2 Exon 20 Inhibitor Program, ORIC-114: In October 2020, ORIC licensed from Voronoi, Inc. exclusive rights worldwide excluding the People’s Republic of China, Hong Kong, Macau and Taiwan (the ORIC Territory) for the development and commercialization of a potential best-in-class brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) with high potency against exon 20 insertion mutations. ORIC expects to file a Clinical Trial Application (CTA) and initiate a global Phase 1/2 tumor-agnostic trial in genetically defined cancers for ORIC-114 in the second half of 2021.

Licensed Exclusive Worldwide Rights to PRC2 Inhibitor, ORIC-944: In August 2020, ORIC licensed from Mirati Therapeutics, Inc. exclusive worldwide development and commercialization rights to a potential best-in-class small molecule allosteric inhibitor program directed towards the polycomb repressive complex 2 (PRC2), a validated oncogenic target across several cancers with promising therapeutic potential in prostate cancer, among other indications. ORIC expects to file an IND for ORIC-944 in the second half of 2021.

Preclinical Data on ORIC-101 Presented at EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper): In October 2020, ORIC presented a poster and oral discussion at the 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium 2020 that demonstrated ORIC-101 reversed glucocorticoid receptor (GR) mediated resistance to an androgen receptor (AR) degrader. Key findings of the presentations included:

Upon treatment of prostate cancer cell lines with an AR degrader, GR mRNA and protein levels were significantly upregulated, similar to the GR upregulation seen after dosing with enzalutamide;
GR upregulation translated into GR activation that conferred resistance to the AR degrader, permitting prostate cancer cells to continue to grow;
ORIC-101 was shown to reverse these effects and block tumor cell growth and androgen-regulated gene expression; and
These data demonstrate that GR may be a mechanism of resistance to AR degraders and that in vitro, ORIC-101 overcomes GR-driven resistance to AR degradation.
Anticipated Milestones
ORIC expects to:

Select the recommended Phase 2 dose for its two ongoing ORIC-101 combination trials in the second half of 2020 and to report interim data from one of the trials in the first half of 2021 and from the other trial in the second half of 2021.
File an Investigational New Drug (IND) Application for ORIC-533 with the Food and Drug Administration (FDA) in the first half of 2021.
File an IND Application for ORIC-944 with the FDA in the second half of 2021.
File a CTA and initiate a global Phase 1/2 tumor-agnostic trial in genetically defined cancers for ORIC-114 in the second half of 2021.
Third Quarter 2020 Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities totaled $186.6 million as of September 30, 2020. The company expects its current cash, cash equivalents and marketable securities will be sufficient to fund its current operating plan into the second half of 2022.

R&D Expenses: Research and development (R&D) expenses were $8.8 million for the three months ended September 30, 2020, compared to $5.6 million for the three months ended September 30, 2019, an increase of $3.2 million. For the nine months ended September 30, 2020, R&D expenses were $23.8 million compared to $15.9 million for the same period of 2019, an increase of $7.9 million. The increases for the 2020 periods were primarily driven by an increase in external expenses related to the advancement of ORIC-101, ORIC-533 and exploratory research programs, as well as higher personnel costs, including additional non-cash stock-based compensation of $0.5 million and $1.2 million for the three and nine months ended September 30, 2020, as compared to the same periods in 2019, respectively.

IPR&D Expenses: In-process research and development (IPR&D) expense of $13.0 million for the three and nine months ended September 30, 2020 related to the non-cash charge the company recorded for the fair value of the 588,235 shares issued to Mirati for the development and commercialization rights to ORIC-944. There were no similar costs incurred in 2019.

G&A Expenses: General and administrative (G&A) expenses were $3.8 million for the three months ended September 30, 2020, compared to $1.5 million for the three months ended September 30, 2019, an increase of $2.3 million. For the nine months ended September 30, 2020, G&A expenses were $9.1 million compared to $3.9 million for the same period in 2019, an increase of $5.2 million. These increases were primarily due to higher personnel costs, including additional non-cash stock-based compensation of $0.9 million and $1.8 million for the three and nine months ended September 30, 2020, as compared to the same periods in 2019, respectively, higher professional services and related costs to operate as a public company.

On November 5, 2020 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor-infiltrating lymphocyte, TIL and peripheral-blood lymphocyte, PBL), reported third quarter 2020 financial results and provided a corporate update (Press release, Iovance Biotherapeutics, NOV 5, 2020, View Source [SID1234570059]).

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"Subsequent to meeting with FDA, we have moved the BLA submission date for lifileucel to 2021 in order to reach agreement on the required potency assays to fully define TIL," said Maria Fardis, PhD, President and CEO of Iovance. "In additional indications, we look forward to starting our registration-directed study in non-small cell lung cancer, and to presenting initial clinical data of TIL in combination with anti-PD-1 therapy in head and neck cancer. Our financial strength also allows us to advance our clinical programs and continue our operating plans. Overall, I believe that Iovance is well-positioned to be the leader in development, manufacturing and commercialization of TIL cell therapy for cancer."

Third Quarter 2020 and Recent Corporate Updates

Clinical:

TIL therapy, lifileucel, in melanoma: Iovance and the U.S. Food and Drug Administration (FDA) reached agreement on duration of follow up for pivotal data for the biologics license application (BLA) for lifileucel in metastatic melanoma. Additional work is underway on current and new potency assays in support of the BLA. Dialogue with FDA about the assays is expected to continue with BLA submission anticipated to occur in 2021.
TIL therapy, lifileucel, in cervical cancer: the last patient was dosed in the pivotal Cohort 1 of the C-145-04 study of lifileucel, formerly LN-145, for metastatic cervical cancer.
TIL therapy in non-small cell lung cancer (NSCLC): the protocol was finalized for the potential registration-directed study, IOV-LUN-202, to investigate LN-145 in patients with recurrent or metastatic NSCLC, without driver mutations, who previously received a single line of approved systemic therapy (combined checkpoint inhibitor (CPI) plus chemotherapy). Cohorts 1 and 3 have patients with TPS score of less than one percent, and Cohort 2 will enroll patients with TPS score of greater than or equal to one percent.
TIL therapy, LN-145, in head and neck squamous cell carcinoma (HNSCC): in the abstract for the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, patients with HNSCC who received LN-145 in combination with pembrolizumab showed an overall response rate (ORR) of 44% and median duration of response had not been reached at 6.9 months of median study follow up (n=9). Updated data will be presented at SITC (Free SITC Whitepaper).
Iovance development program: to date, over 400 patients have been dosed with Iovance TIL products with more than 90 percent manufacturing success rate.
Manufacturing:

Construction of the Iovance Cell Therapy Center (iCTC) is advancing as planned at the Navy Yard in Philadelphia. Clean rooms are expected to be completed in late 2020 with clinical activities to initiate in early 2021. Commercial manufacturing is on track for 2022.
Corporate:

Cash position of $719.7 million at September 30 is sufficient for Iovance to execute commercial launch and pipeline programs, including the IOV-LUN-202 study in NSCLC.
A strong organization of over 200 employees is in place across multiple locations to advance research, development, manufacturing and commercial launch preparations.
Iovance has been granted or allowed a total of 20 U.S. patents for compositions and methods of treatment in using Iovance TIL in a broad range of cancers related to its 22-day second generation (Gen 2) manufacturing process.
Upcoming Data in Head and Neck Cancer at SITC (Free SITC Whitepaper) Annual Meeting (November 9-14, 2020):

Poster Presentation (Abstract #353): Safety and efficacy of tumor infiltrating lymphocytes (TIL; LN-145) in combination with pembrolizumab for advanced, recurrent or metastatic HNSCC
Authors: A Jimeno, et al.
Presentation Times: Wednesday, Nov. 11, from 5:15-5:45 p.m. EST and Friday, Nov. 13, from 4:40-5:10 p.m. EST.
Location: Virtual Poster Hall
Third Quarter and September Year-to-Date Financial Results

Iovance held $719.7 million in cash, cash equivalents, short-term investments and restricted cash at September 30, 2020 compared to $312.5 million at December 31, 2019. The current cash position includes net proceeds of $567.0 million from a common stock public offering in June 2020. The company anticipates that the year-end balance of cash, cash equivalents, short-term investments and restricted cash may be over $630 million.

Net loss for the third quarter ended September 30, 2020, was $58.6 million, or $0.40 per share, compared to a net loss of $49.5 million, or $0.40 per share, for the third quarter ended September 30, 2019. Net loss for the nine months ended September 30, 2020, was $191.2 million, or $1.41 per share, compared to a net loss of $134.0 million, or $1.08 per share, for the same period ended September 30, 2019.

Research and development expenses were $43.1 million for the third quarter ended September 30, 2020, an increase of $1.5 million compared to $41.6 million for the third quarter ended September 30, 2019. Research and development expenses were $149.3 million for the nine months ended September 30, 2020, an increase of $37.5 million compared to $111.8 million for the same period ended September 30, 2019.

The increase in research and development expenses in the third quarter 2020 over the prior year period was primarily attributable to growth of the internal research and development team and higher stock-based compensation, partially offset by a decrease in manufacturing costs. The increase in research and development expenses in the first nine months of 2020 over the prior year period was primarily attributable to higher patient enrollment in clinical trials, licensing fees and growth of the internal research and development team.

General and administrative expenses were $15.9 million for the third quarter ended September 30, 2020, an increase of $5.9 million compared to $10.0 million for the third quarter ended September 30, 2019. General and administrative expenses were $44.1 million for the nine months ended September 30, 2020, an increase of $14.2 million compared to $30.0 million for the same period ended September 30, 2019.

The increases in general and administrative expenses in the third quarter and first nine months of 2020 compared to the prior year periods were primarily attributable to growth of the internal general and administrative team and higher stock-based compensation expenses.

Webcast and Conference Call

Iovance will host a conference call today at 4:30 p.m. ET to discuss the third quarter and year-to-date 2020 financial results and to provide a corporate update. The conference call dial-in numbers are 1-844-646-4465 (domestic) or 1-615-247-0257 (international). The conference ID access number for the call is 1190777. The live webcast can be accessed in the Investors section of the company’s website at View Source The archived webcast will be available for a year in the Investors section at www.iovance.com.