On November 4, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer and population sequencing, reported financial results for the third quarter ended September 30, 2021 (Press release, Personalis, NOV 4, 2021, View Source [SID1234594516]).

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Third Quarter and Recent Highlights

Reported quarterly revenue of $22.3 million in the third quarter of 2021 compared with $19.8 million in the third quarter of 2020, a 12% increase
Record quarterly revenue of $8.6 million from biopharma and all other customers, excluding the U.S. Department of Veterans Affairs Million Veteran Program (VA MVP), in the third quarter of 2021 compared with $5.7 million in the third quarter of 2020, a 50% increase
Record new orders received for cancer genomic testing from biopharma and all other customers, excluding the VA MVP; order value of more than three-times (3x) the amount of quarterly revenue reported in the third quarter of 2021
Received new order from the VA MVP with an aggregate value of approximately $10 million over a six-month period of performance from September 17, 2021 to March 31, 2022
Announced a collaboration with Mayo Clinic to provide clinical-grade comprehensive cancer genomic sequencing for patients; creates framework for Personalis to sponsor future defined research studies and establishes Personalis as a preferred provider to Mayo Clinic for research and clinical sequencing and analysis services, particularly in the area of immuno-oncology
Announced the appointment of Robert Bruce to the newly created position of Vice President, Reimbursement; the new role is tasked with driving efforts with Medicare and private payers
Announced the signing of a new building lease agreement in Fremont, California for approximately 100K square feet for laboratory capacity and office space, which is planned to be the new company headquarters and support future growth
Ended the third quarter of 2021 with cash and cash equivalents and short-term investments of $305.2 million
"I’m proud to say that revenue from our oncology customers grew 50% over the same period of the prior year, and increased sequentially for the eighth consecutive quarter. In addition, our new-orders-to-revenue ratio during the third quarter was more than three-to-one, and gives us confidence in our future growth," said John West, Chief Executive Officer. "Looking ahead, and building on our recent oncology success, we are working to enhance our clinical, regulatory, and reimbursement capabilities as we prepare to launch NeXT Personal, our Minimal Residual Disease (MRD) offering in December as planned. We expect initial orders to come from our pharma customers and, later in 2022, we will pursue orders for patient diagnostic tests in clinical settings."

Third Quarter 2021 Financial Results

Revenue was $22.3 million in the three months ended September 30, 2021, up 12% from $19.8 million in the same period of the prior year.

Gross margin was 36.2% in the three months ended September 30, 2021, compared with 26.9% in the same period of the prior year.

Operating expenses were $25.8 million in the three months ended September 30, 2021, compared with $15.0 million in the same period of the prior year.

Net loss was $17.7 million in the three months ended September 30, 2021 and net loss per share was $0.40 based on a weighted-average basic and diluted share count of 44.5 million, compared with a net loss of $9.5 million and a net loss per share of $0.27 based on a weighted-average basic and diluted share count of 35.5 million in the same period of the prior year.

Business Outlook

Personalis expects the following for the fourth quarter of 2021:

Total revenue to be in the range of $20.2 million to $20.4 million
Revenue from biopharma and all other customers, excluding VA MVP, to be in the range of $12.5 million to $14.5 million
Net Loss to be in the range of $22 million to $23 million and estimated outstanding shares of approximately 45 million
Personalis expects the following for the full year of 2021:

Total revenue to be approximately $85 million
Revenue from biopharma and all other customers, excluding VA MVP, to be in the range of $37 million to $39 million
Net Loss to be in the range of $67 million to $68 million and estimated outstanding shares of approximately 45 million
Webcast and Conference Call Information

Personalis will host a conference call to discuss the third quarter 2021 financial results before market opens on Thursday, November 4, 2021 at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time. The conference call can be accessed live over the phone by dialing (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using the conference ID: 7896264. The live webinar can be accessed at View Source

On November 4, 2021 Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, reported that data at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (December 11-14) will showcase continued leadership across both approved and investigational CAR T-cell therapies and medicines (Press release, Gilead Sciences, NOV 4, 2021, View Source [SID1234594534]). Gilead and Kite will present more than 20 abstracts, including a plenary presentation and six oral presentations, across several hematological malignancies including large B-cell lymphoma (LBCL), non-Hodgkin lymphoma (NHL), acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

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"This ASH (Free ASH Whitepaper) meeting illustrates the growing maturity of data regarding the potential of our CAR T-cell therapies to be used earlier in treatment along with long-term follow-up data," said Frank Neumann, MD, PhD, Kite’s Global Head of Clinical Development. "As we continue to build on the established strengths of Kite’s CAR T franchise, our goal is to provide differentiated treatment options to patients that have the potential to change standard of care and deliver the hope of survival to more people with blood cancers."

In cell therapy, Kite will present the first efficacy and safety results from the landmark ZUMA-7 study in LBCL as part of ASH (Free ASH Whitepaper)’s plenary sessions. Additional research from Kite, focused on long-term follow-up data and quality of life improvements for people with certain blood cancers treated with the company’s CAR T-cell therapies, will also be presented.

"The Gilead and Kite data presentations at ASH (Free ASH Whitepaper) reinforce our diverse oncology pipeline focused on helping bring more life to people with cancer, especially in areas where few options exist," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "We see broad potential across our oncology portfolio as we advance transformative science for people with hard-to-treat blood cancers."

Researchers will also share early-stage research on magrolimab, an investigational CD47 inhibitor, both in an oral session and in an ASH (Free ASH Whitepaper)-EHA Joint Symposium. During the symposium, Targeting Macrophages and the Innate Immune System to Treat Hematologic Malignancies, potential new approaches to cancer therapies will be showcased. Early data suggest these approaches, including activating the innate immune system, could become foundational to the next generation of oncology treatment.

Dates and times for accepted abstracts and presentations of note are as follows:

Abstract Details

Titles

Plenary Session

Large B-cell Lymphoma

Abstract #2

Sunday, Dec 12

(2:00 pm ET / 11:00 am PT)

Primary Analysis of ZUMA-7: A Phase 3 Randomized Trial of Axicabtagene Ciloleucel Versus Standard-of-Care Therapy in Patients with Relapsed/Refractory Large B-Cell Lymphoma

Oral Presentations

Large B-cell Lymphoma

Abstract #430

Sunday, Dec 12

(10:15 am ET / 7:15 am PT)

Patient-Reported Outcomes in a Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard-of-Care Therapy in Patients with Relapsed/Refractory Large B-Cell Lymphoma (ZUMA-7)

Large B-cell Lymphoma

Abstract #530

Sunday, Dec 12

(4:45 pm ET / 1:45pm PT)

Real-World Outcomes of Axicabtagene Ciloleucel for the Treatment of Large B-Cell Lymphoma: Impact of Age and Specific Organ Dysfunction

Large B-cell Lymphoma

Abstract #739

Monday, Dec 13

(2:45 pm ET / 11:45 am PT)

Primary Analysis of ZUMA-12: A Phase 2 Study of Axicabtagene Ciloleucel as First-Line Therapy in Patients with High-Risk Large B-Cell Lymphoma

Large B-cell Lymphoma

Abstract #901

Monday, Dec 13

(6:15 pm ET / 3:15 pm PT)

TNFR2 as a Target to Improve CD19-Directed CAR T-Cell Fitness and Antitumor Activity in Large B-Cell Lymphoma

Non-Hodgkin Lymphoma

Abstract #93

Saturday, Dec 11

(10:00 am ET / 7:00 am PT)

Long-Term Follow-Up Analysis of ZUMA-5: A Phase 2 Study of Axicabtagene Ciloleucel in Patients with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma

Investigator-Sponsored Research (ISR) Oral Presentation

Acute Myeloid Leukemia

Abstract #371

Sunday, Dec 12

(9:30 am ET / 6:30 am PT)

Phase I/II Study of Azacitidine with Venetoclax and Magrolimab in Patients with Newly Diagnosed Older/Unfit or High-Risk Acute Myeloid Leukemia (AML) and Relapsed/Refractory AML

Poster Presentations

Large B-cell Lymphoma
Abstract #1764

Saturday, Dec 11

(5:30 pm ET / 2:30 pm PT)

Long-Term (4- and 5-Year) Overall Survival in ZUMA-1, the Pivotal Study of Axicabtagene Ciloleucel (Axi-Cel) in Patients with Refractory Large B-Cell Lymphoma (LBCL)

Large B-cell Lymphoma
Abstract #1424

Saturday, Dec 11

(5:30 pm ET / 2:30 pm PT)

Chimeric Antigen Receptor T-Cell Therapy Treatment Patterns: A Retrospective Cohort Analysis of Relapsed or Refractory Diffuse Large B-Cell Lymphoma Patients in the US

Follicular Lymphoma
Abstract #1350
Saturday, Dec 11
(5:30 pm ET / 2:30 pm PT)

Safety and Effectiveness of Idelalisib in Patients with Double Refractory Follicular Lymphoma: A Pan European Cohort of 242 Patients

Large B-cell Lymphoma Abstract #2832

Sunday, Dec 12

(6:00 pm ET / 3:00 pm PT)

Prophylactic Corticosteroid Use with Axicabtagene Ciloleucel in Patients with Relapsed/Refractory Large B-Cell Lymphoma: One-Year Follow-Up of ZUMA-1 Cohort 6

Large B-cell Lymphoma
Abstract #151459

Sunday, Dec 12

(6:00 pm ET / 3:00 pm PT)

Profiling the Peripheral Blood Immune Cell Repertoire in Large B-Cell Lymphoma Patients Treated with CD19 CAR-T

Large B-cell Lymphoma

Abstract #2814

Sunday, Dec 12

(6:00 pm ET / 3:00 pm PT)

A Phase II Trial of Anakinra for the Prevention of CAR T-Cell Mediated Neurotoxicity

Large B-cell Lymphoma Abstract #2833

Sunday, Dec 12

(6:00 pm ET / 3:00 pm PT)

Prediction of Early Onset Cytokine Release Syndrome and Neurologic Events After Axicabtagene Ciloleucel in Large B-Cell Lymphoma Based on Machine Learning Algorithms

Follicular Lymphoma
Abstract #3543

Monday, Dec 13

(6:00 pm ET / 3:00 pm PT)

A Comparison of Clinical Outcomes from Updated ZUMA-5 (Axicabtagene Ciloleucel) and the International SCHOLAR-5 External Control Cohort in Relapsed/Refractory Follicular Lymphoma

Mantle Cell Lymphoma

Abstract #3844

Monday, Dec 13

(6:00 pm ET / 3:00 pm PT)

The Comparison of KTE-X19 to Current Standards of Care: A Pre-Specified Synthetic Control Study Utilizing Individual Patient Level Data from Historic Clinical Trials (SCHOLAR-3)

Mantle Cell Lymphoma

Abstract #3849

Monday, Dec 13

(6:00 pm ET / 3:00 pm PT)

Effects of Prior Exposure to Tec Kinase Inhibitors on KTE-X19 Products

Trials-In-Progress (TiP)

Multiple Myeloma

Abstract #2757

Sunday, Dec 12

(6:00 pm ET / 3:00 pm PT)

A Phase 2 Multi-Arm Study of Magrolimab Combinations in Patients with Relapsed/Refractory Multiple Myeloma

Acute Myeloid Leukemia

Abstract #3424

Monday, Dec 13

(6:00 pm ET / 3:00 pm PT)

A Phase 2, Open-Label, Multiarm, Multicenter Study to Evaluate Magrolimab Combined with Antileukemia Therapies for First-Line, Relapsed/Refractory, or Maintenance Treatment of Acute Myeloid Leukemia

Acute Myeloid Leukemia

Abstract# 3426

Monday Dec 13

(6:00 pm ET / 3:00 pm PT)

A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination with Azacitidine in Previously Untreated Patients with TP53-Mutant Acute Myeloid Leukemia

Myelodysplastic Syndrome

Abstract #7055

Monday, Dec 13

(6:00 pm ET / 3:00 pm PT)

Magrolimab + Azacitidine versus Azacitidine + Placebo in Untreated Higher-Risk (HR) Myelodysplastic Syndrome (MDS): The Phase 3 Randomized, ENHANCE Study

For more information, including a complete list of abstract titles at the meeting, please visit: View Source

On November 4, 2021 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported financial results for the third quarter ended September 30, 2021 and provided a corporate update (Press release, Jounce Therapeutics, NOV 4, 2021, View Source [SID1234594563]).

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"Jounce has had another very productive quarter as we have made significant progress across all areas of the company and continue to build momentum as we head into the new year. We were pleased to report that we are now actively recruiting patients in the monotherapy and combination therapy expansion portion of the INNATE study, testing JTX-8064 +/- pimivalimab, our own PD-1 inhibitor, in 8 distinct cohorts across 7 tumor types. We also continue to advance patient enrollment in our randomized SELECT study which employs our stringent patient selection strategy and have continued our commitment to build our discovery pipeline," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "We believe our focus on translational science, biomarker approaches, and targeting new immune mechanisms leads us closer to bringing the right immunotherapies to the right patients."

Pipeline Update:

JTX-8064 (LILRB2 / ILT4)

Completed monotherapy and combination therapy dose escalation 3 week safety review of INNATE: Jounce has completed the monotherapy and pimivalimab (PD-1 Inhibitor) combination therapy dose escalation 3 week safety review of the Phase 1 trial of JTX-8064, and a preliminary recommended phase 2 dose (RP2D) of 700 mg has been established. To date, JTX-8064 has been well tolerated with no dose limiting toxicities.

Enrollment initiated in tumor-specific monotherapy and pimivalimab combination expansion cohorts of INNATE: Jounce previously announced the initiation of patient enrollment in INNATE tumor-specific expansion cohorts for both JTX-8064 monotherapy and combination therapy of JTX-8064 with pimivalimab in August and October, respectively. The expansion cohorts will study JTX-8064 in three subsets of patients in order to identify the most rapid development paths for JTX-8064 alone or in combination with PD-1 inhibitors:

Patients who have progressed on PD-1 inhibitors and are now PD-1 inhibitor resistant,
PD-1 inhibitor naïve patients with tumors that do not typically respond to PD-1 inhibitors, and
PD-1 inhibitor naïve patients with tumors for which PD-1 inhibitors are approved, but there is still room for improvement.

Vopratelimab (ICOS) and Pimivalimab (PD-1)

Continued enrollment in Phase 2 SELECT trial of vopratelimab: Enrollment continues in SELECT, a randomized Phase 2 trial to evaluate vopratelimab in combination with pimivalimab versus pimivalimab alone in immunotherapy naïve, TISvopra biomarker-selected, second line non-small cell lung cancer (NSCLC) patients. The SELECT trial also aims to provide additional important single agent data for pimivalimab in a new biomarker selection paradigm. Jounce is on track to report data from the SELECT trial in 2022.

Gilead Sciences begins Phase 1 clinical trial of GS-1811 (formerly JTX-1811)

The clinical study of GS-1811 (formerly JTX-1811) was initiated by Gilead Sciences. GS-1811, which Jounce discovered and progressed through to IND, is out licensed to Gilead and is the fourth internally developed candidate to enter the clinic.

Corporate Update:

Jigar Raythatha Appointed to the Board of Directors

On September 15th, 2021, Jounce announced the appointment of former chief executive officer of Constellation Pharmaceuticals and former Jounce chief business officer, Jigar Raythatha, to its board of directors.

Third Quarter 2021 Financial Results:

Cash position: As of September 30, 2021, cash, cash equivalents and investments were $249.0 million, compared to $213.2 million as of December 31, 2020. The increase was primarily due to receipt of $90.9 million in net proceeds from the follow-on public offering and sales under Jounce’s at-the-market ("ATM") offering program completed first quarter of 2021 and receipt of a $25.0 million milestone from Gilead in the third quarter of 2021, offset by operating expenses incurred.

License and collaboration revenue: No license or collaboration revenue was recognized in the third quarter of 2021 or 2020.

Research and development expenses: Research and development expenses were $23.3 million for the third quarter of 2021, compared to $18.0 million for the same period in 2020. The increase in research and development expenses was primarily due to increased clinical and regulatory costs for INNATE and SELECT, increased manufacturing activities performed for Jounce’s development programs and payroll and stock-based compensation expense.

General and administrative expenses: General and administrative expenses were $6.9 million for the third quarter of 2021, compared to $7.1 million for the same period in 2020. The decrease in general and administrative expenses was primarily a result of decreased professional fees offset by increases in other administrative costs.

Net loss: Net loss was $30.1 million for the third quarter of 2021, resulting in basic and diluted net loss per share of $0.59. Net loss was $24.9 million for the same period in 2020, resulting in a basic and diluted net loss per share of $0.73. The increase in net loss is attributable to increased operating expenses, the decrease in the net loss per share is attributable to increased number of shares outstanding as compared to the same period in 2020.

Financial Guidance:

Based on its current operating and development plans, Jounce is narrowing its financial guidance on gross cash burn on operating expenses and capital expenditures for the full year 2021 to $100.0 million to $110.0 million. Jounce expects to end fiscal year 2021 with approximately $220.0 million in cash, cash equivalents and investments.

Given the strength of its balance sheet, Jounce continues to expect its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements through the third quarter of 2023.

Conference Call and Webcast Information:

Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 6873343. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. The webcast will be archived and made available for replay on Jounce’s website approximately two hours after the call and will be available for 30 days.

About JTX-8064

JTX-8064 is a humanized IgG4 monoclonal antibody designed to specifically bind to Leukocyte Immunoglobulin Like Receptor B2 (LILRB2/ILT4) and block interactions with its ligands. JTX-8064 is the first tumor-associated macrophage candidate developed from Jounce’s Translational Science Platform. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s Annual Meeting and the 2019 and 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meetings support the development of JTX-8064 as a novel immunotherapy to reprogram immune-suppressive macrophages and enhance anti-tumor immunity. A Phase 1 clinical trial named INNATE (NCT04669899) of JTX-8064 as a monotherapy and in combination with Jounce’s internal anti-PD-1 inhibitor, pimivalimab (formerly JTX-4014) is currently enrolling patients with advanced solid tumors into tumor-specific expansion cohorts.

About Pimivalimab

Pimivalimab (formerly JTX-4014) is a well-characterized fully human IgG4 monoclonal antibody designed to block binding to PD-L1 and PD-L2. Pimivalimab demonstrated a 17% durable overall response rate in a Phase 1 trial of 18 heavily pre-treated PD-(L)1 inhibitor naïve patients, which excluded all tumor types for which PD-(L)1 inhibitors were approved. In this Phase 1 trial, pimivalimab was shown to have an acceptable safety profile. Pimivalimab is currently being assessed in the INNATE Phase 1 trial (NCT04669899) in combination with JTX-8064, a LILRB2 (ILT4) inhibitor. Pimivalimab is also being assessed in the SELECT Phase 2 clinical trial (NCT04549025) in combination with vopratelimab, a clinical-stage monoclonal antibody that binds to and activates ICOS, the Inducible T cell CO-Stimulator, a protein on the surface of certain T cells commonly found in many solid tumors.

About Vopratelimab

Vopratelimab is a clinical-stage monoclonal antibody that binds to and activates ICOS, the Inducible T cell CO-Stimulator, a protein on the surface of certain T cells commonly found in many solid tumors. Vopratelimab is currently being assessed in the SELECT Phase 2 clinical trial (NCT04549025) in combination with Jounce’s internal investigational PD-1 inhibitor, pimivalimab (formerly JTX-4014), compared to pimivalimab alone. The SELECT trial is currently enrolling approximately 75 immunotherapy naïve NSCLC patients who have been pre-selected with the TISvopra predictive biomarker, an 18 gene RNA tumor inflammation signature which predicted the emergence of ICOS hi CD4 T cells and clinical benefit in the ICONIC trial of vopratelimab alone and in combination with a PD-1 inhibitor. SELECT is powered to demonstrate the statistical superiority of the combination of vopratelimab plus pimivalimab compared to pimivalimab.

On November 4, 2021 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 and year-to-date 2021 financial results and corporate updates (Press release, Iovance Biotherapeutics, NOV 4, 2021, View Source [SID1234594594]).

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Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "During 2021, we have continued to report long-term clinical data demonstrating the durability of one-time treatment with lifileucel in metastatic melanoma while broadening the potential for TIL cell therapy to address more patients in additional indications and treatment settings. We look forward to highlighting our TIL cell therapy platform at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting. Our top priority remains our ongoing work to address feedback from the U.S. Food and Drug Administration (FDA) regarding the potency assays for lifileucel to support our planned biologics license application (BLA) submission. We remain increasingly confident in the broad potential for TIL as the next class of paradigm-shifting therapy for cancer patients with significant unmet need."

Third Quarter 2021 Highlights and Recent Corporate Updates

Regulatory

Potency assays for lifileucel: Following FDA feedback regarding the potency assays for lifileucel, Iovance has continued ongoing work developing and validating its potency assays and has engaged in discussions with the FDA during the second half of 2021. The anticipated BLA submission for lifileucel continues to be planned for the first half of 2022. Resolution of the potency assay for lifileucel in melanoma is also a key step towards our regulatory plans in other indications.
U.S. FDA Fast Track designation for lifileucel in combination with pembrolizumab in metastatic melanoma: The FDA granted Fast Track designation for lifileucel in combination with pembrolizumab for the treatment of metastatic melanoma based on the unmet medical need and potential advantages for this combination over available care. Fast Track designation allows for potential Accelerated Approval and Priority Review as well as more frequent interactions with the FDA.
Clinical

TIL therapy in combination with pembrolizumab in advanced solid tumor cancers: Iovance is investigating TIL in combination with pembrolizumab in earlier treatment settings in metastatic melanoma, cervical cancer, non-small cell lung cancer (NSCLC), and head and neck squamous cell carcinoma (HNSCC) patients who are naïve to therapy with immune checkpoint inhibitors (ICI). Data for certain indications for TIL in combination with pembrolizumab will be highlighted in an oral presentation at the upcoming SITC (Free SITC Whitepaper) annual meeting. Early clinical data previously presented in metastatic melanoma (ASCO 2021) and HNSCC (SITC 2020) suggest that the response rate for TIL in combination with pembrolizumab may be increased in patients who are ICI-naïve.
TIL therapy in NSCLC:
LN-145 clinical data in metastatic NSCLC (mNSCLC): Detailed results from Cohort 3B in the IOV-COM-202 study will be highlighted in a poster presentation at the SITC (Free SITC Whitepaper) annual meeting. As previously reported, clinical data for LN-145 showed a 21.4% overall response rate (ORR) and 64.3% disease control rate in heavily pretreated mNSCLC patients who received one or more prior systemic therapies, including anti-PD-1 therapy.
LN-145 in second-line mNSCLC: Enrollment is ongoing and more than 20 clinical sites are activated in the U.S. and Canada for the IOV-LUN-202 study of LN-145 in patients with mNSCLC.
Research

Iovance continues to advance the next generation of TIL and related therapies and technologies. Late preclinical programs in investigational new drug (IND)-enabling studies include a novel IL-2 analog (IOV-3001) as well as a genetically modified TIL (IOV-4001). IOV-4001 leverages TALEN technology licensed from Cellectis S.A. to inactivate PD-1 expression by the TIL product.
Iovance and the National Institutes of Health (NIH) extended their Cooperative Research and Development Agreement (CRADA) through August 2024. The CRADA focuses on emerging areas of translational and clinical research for TIL therapies.
Manufacturing

TIL manufacturing success: To date, more than 500 patients have been dosed with Iovance TIL products with more than a 90 percent manufacturing success rate.
Iovance Cell Therapy Center (iCTC): Clinical manufacturing of TIL commenced at the iCTC in September of 2021. Commercial manufacturing remains on track to commence with a potential regulatory approval. The iCTC achieved LEED Gold Certification through the U.S. Green Building Council (USGBC).
Corporate

Cash position of $660.8 million at September 30, 2021 is expected to be sufficient well into 2023.
A strong organization of more than 300 employees with an average of more than 3.5 years of cell therapy experience is in place to advance research, development, manufacturing, and commercial launch preparations.
Iovance continues to expand its intellectual property portfolio and currently owns more than 30 granted or allowed U.S. and international patents for TIL compositions and methods of treatment and manufacturing in a broad range of cancers. Iovance’s Gen 2 patent rights are expected to provide exclusivity through 2038. Iovance’s portfolio also includes patent applications and granted patents directed towards Gen 3 manufacturing, selected TIL products, stable and transient genetic TIL modifications, tumor digest and fragment compositions and methods (including cryopreservation), and combinations of checkpoint inhibitors and TIL products.
Third Quarter and Year-to-Date 2021 Financial Results

Iovance has $660.8 million in cash, cash equivalents, investments and restricted cash at September 30, 2021 compared to $635.0 million at December 31, 2020. The cash position is expected to be sufficient to fund current and planned operations well into 2023.

Jean-Marc Bellemin, Chief Financial Officer, stated, "With the continued strength of our balance sheet and focused investment on pipeline development and launch preparations, we are well positioned to execute our operating plan with no immediate need to raise additional capital. Following completion of the iCTC, we have also concluded our initial $85 million investment in constructing the facility."

Net loss for the third quarter ended September 30, 2021, was $86.1 million, or $0.55 per share, compared to a net loss of $58.6 million, or $0.40 per share, for the third quarter ended September 30, 2020. Net loss for the nine months ended September 30, 2021, was $242.9 million, or $1.60 per share, compared to a net loss of $191.2 million, or $1.41 per share, for the same period ended September 30, 2020.

Research and development expenses were $65.4 million for the third quarter ended September 30, 2021, an increase of $22.3 million compared to $43.1 million for the third quarter ended September 30, 2020. Research and development expenses were $183.4 million for the nine months ended September 30, 2021, an increase of $34.1 million compared to $149.3 million for the same period ended September 30, 2020.

The increase in research and development expenses in the third quarter 2021 over the prior year period was primarily attributable to an increase in costs associated with growth of the internal research and development team and increases in clinical trial costs and iCTC facility related costs. The increase in research and development expenses in the first nine months of 2021 over the prior year period was primarily attributable to growth of the internal research and development team and an increase in iCTC facility related costs.

General and administrative expenses were $20.9 million for the third quarter ended September 30, 2021, an increase of $5.0 million compared to $15.9 million for the third quarter ended September 30, 2020. General and administrative expenses were $59.8 million for the nine months ended September 30, 2021, an increase of $15.7 million compared to $44.1 million for the same period ended September 30, 2020.

The increases in general and administrative expenses in the third quarter and first nine months of 2021 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 2021 financial results and corporate updates. The conference call dial-in numbers are 1-(844) 646-4465 (domestic) or 1-(615) 247-0257 (international) and the access code is 7286232. 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.

On November 4, 2021 bluebird bio, Inc. (NASDAQ: BLUE) reported the company has completed the tax-free spin-off of its oncology programs and portfolio into 2seventy bio, Inc., an independent, publicly-traded company (Press release, bluebird bio, NOV 4, 2021, View Source [SID1234594657]). bluebird bio will continue its work focused on severe genetic disease, with three near-term opportunities to bring transformative gene therapies to patients and their families in the U.S. 2seventy will begin regular-way trading on the NASDAQ under the stock ticker symbol "TSVT" on November 5, 2021. bluebird bio will continue to trade under the stock ticker symbol "BLUE."

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"Over more than a decade, bluebird bio has set the standard for gene therapy and with more than 485 patient years of experience, we have amassed the largest and deepest ex-vivo gene therapy data set in the world," said Andrew Obenshain, chief executive officer, bluebird bio. "As a dedicated severe genetic disease company, we are prepared to unlock the full value of our pipeline through the anticipated launch of three, first-in-class therapies for patients with sickle cell disease, β-thalassemia and cerebral adrenoleukodystrophy, and to realize the potential of gene therapy to transform lives for patents and their families now and in the future."

bluebird bio is led by an experienced team composed of tenured bluebird leaders and recent additions, focused on executing against a clear strategy to develop and commercialize the company’s lentiviral vector gene therapies and to deliver with increased fiscal discipline.

In September 2021, bluebird announced that it had submitted a biologics licensing application to the U.S. Food and Drug Administration for betibeglogene autotemcel (beti-cel) for patients with β-thalassemia who require regular red blood cell transfusions. The BLA filing for elivaldogene autotemcel (eli-cel, Lenti-D) for patients with cerebral adrenoleukodystrophy (CALD) is on track for the end of 2021.

bluebird bio will host a spotlight and regulatory update on its bb1111 (LentiGlobin for Sickle Cell Disease) product candidate, an investigational lentiviral vector gene therapy for sickle cell disease, for analysts and investors on Thursday, November 18, 2021, at 8:00 am ET. Investors may listen to the call by dialing (833) 857-1010 from locations in the United States or +1 (929) 517-0312 from outside the United States. Please refer to conference ID number 5780005.