On May 6, 2021 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, reported financial results for the first quarter ended March 31, 2021 and provided business updates (Press release, ADC Therapeutics, MAY 6, 2021, View Source [SID1234579403]).

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"We are off to an exciting start to the year with the recent accelerated FDA approval of ZYNLONTA, bringing a new and differentiated treatment option to patients with relapsed or refractory diffuse large B-cell lymphoma," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "ZYNLONTA is approved for a broad population of r/r DLBCL patients, including DLBCL NOS, DLBCL arising from low grade lymphoma and also high-grade B-cell lymphoma. This reflects the real world population of patients enrolled in our LOTIS-2 pivotal trial including transplant eligible and ineligible patients, heavily pre-treated patients and patients with difficult-to-treat disease. In addition, we continue to advance our pipeline of next-generation ADCs for patients with difficult-to-treat hematologic and solid tumor cancers."

"On the occasion of the commercial launch of ZYNLONTA, it has been impressive to see the high quality of talented and experienced commercial and medical affairs professionals at ADC Therapeutics fully prepared for an early FDA approval," said Ron Squarer, Chairman of the Board and an advisor to the Company. "This team is executing on its launch plan and is well equipped to support the treating community in adopting an important new option with a broad label which included tough to treat patients in third-line plus DLBCL."

Recent Highlights

ZYNLONTA (loncastuximab tesirine-lpyl)

FDA accelerated approval and launch: ZYNLONTA was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on April 23, 2021, as a single-agent for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma, a key point of differentiation on the label. ZYNLONTA became commercially available last week and the commercial launch is fully underway.
Added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: As of May 5, 2021, ZYNLONTA was added to the NCCN guidelines with a category 2A recommendation for third-line plus DLBCL, including DLBCL arising from low-grade lymphoma such as follicular lymphoma (FL) and marginal zone lymphoma (MZL).
Ongoing trials progressing:
The Phase 3 LOTIS-5 clinical trial is evaluating ZYNLONTA in combination with rituximab in second-line patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant. This trial will fulfill the post-marketing approval requirement with the FDA for a confirmatory study.
The pivotal Phase 2 LOTIS-3 clinical trial of ZYNLONTA in combination with ibrutinib for relapsed or refractory DLBCL patients is intended to support the submission of a supplemental Biologics License Application (BLA) for ZYNLONTA in combination with ibrutinib.
Additional planned trials in 2021 to potentially expand the ZYNLONTA opportunity:
Pivotal Phase 2 clinical trial in follicular lymphoma (FL).
Clinical trial to evaluate ZYNLONTA in combination with multiple other drugs in B-cell non-Hodgkin lymphoma (NHL).
Dose-finding study of ZYNLONTA in combination with R-CHOP in frontline DLBCL.
Camidanlumab Tesirine (Cami)

Ongoing trials progressing:
The pivotal Phase 2 clinical trial evaluating the efficacy and safety of Cami in patients with relapsed or refractory Hodgkin lymphoma (HL) has completed enrollment and is continuing to follow patients. The Company will present data from this study at an upcoming congress.
The Phase 1b clinical trial of Cami in combination with pembrolizumab in selected advanced solid tumors is an open-label, dose-escalation and dose-expansion trial evaluating the safety, tolerability, pharmacokinetics and antitumor activity of Cami in combination with pembrolizumab, a checkpoint inhibitor.
2021 Expected Milestones

ZYNLONTA

Initiate a pivotal Phase 2 clinical trial of ZYNLONTA in FL in the second quarter of 2021.
Report updated data from the Phase 1 clinical trial of ZYNLONTA in combination with ibrutinib in relapsed or refractory DLBCL in the second quarter of 2021.
Initiate the dose-finding study of ZYNLONTA in first-line DLBCL with R-CHOP in the second half of 2021.
Initiate the clinical trial to evaluate ZYNLONTA in multiple combinations in B-cell non-Hodgkin lymphoma in the second half of 2021.
Complete enrollment in the pivotal Phase 2 trial of ZYNLONTA in combination with ibrutinib in the second half of 2021.
Complete safety lead-in of the Phase 3 LOTIS-5 confirmatory study of ZYNLONTA in combination with rituximab in the second half of 2021.
Cami

Report interim results from the pivotal Phase 2 clinical trial of Cami in HL in the second quarter of 2021.
Earlier-Stage Pipeline

File Investigational New Drug (IND) application for ADCT-901, targeting KAAG1 in the second quarter of 2021.
Initiate a Phase 1b combination study of ADCT-601, targeting AXL, in multiple solid tumors in the first half of 2022.
First Quarter 2021 Financial Results

Cash and Cash Equivalents

Cash and cash equivalents were $383.1 million as of March 31, 2021, compared to $439.2 million as of December 31, 2020. In the coming days, the Company will be drawing down $50 million associated with its Convertible Credit Facility with Deerfield, which was contingent upon ZYNLONTA approval.

Research and Development (R&D) Expenses

R&D expenses were $39.2 million for the quarter ended March 31, 2021, compared to $35.4 million for the same quarter in 2020. R&D expenses increased due to investments to explore the potential of ZYNLONTA in earlier lines of treatment and histologies and advance the portfolio. As a result of these initiatives, employee headcount and share-based compensation expense increased.

Selling and Marketing (S&M) Expenses

During the first quarter of 2021, S&M expenses were $13.9 million as compared to $2.6 million for the same quarter in 2020. The increase in S&M expenses related to the build-out of the Company’s commercial organization and preparation activities for the anticipated launch of ZYNLONTA in 2021. Prior to December 31, 2020, S&M expenses were reported within General and Administrative ("G&A") expenses within the condensed consolidated interim statement of operations. The period ended March 31, 2020 has been recast to conform to the current year presentation.

G&A Expenses

G&A expenses were $17.6 million for the quarter ended March 31, 2021, compared to $5.9 million for the same quarter in 2020. G&A expenses increased due to higher headcount to support the commercial launch, increased share‐based compensation expense and higher costs of being a public company.

Net Loss and Adjusted Net Loss

Net loss was $51.5 million, or a net loss of $0.67 per basic and diluted share, for the quarter ended March 31, 2021, compared to $43.5 million, or a net loss of $0.85 per basic and diluted share, for the same quarter in 2020. The net loss for the quarter ended March 31, 2021 includes a $21.2 million non-cash gain related to the changes in fair value of derivatives associated with the convertible loans under the Convertible Credit Facility with Deerfield. The decrease in fair value was driven by the decrease in the Company’s share price from December 31, 2020. In addition, net loss included share-based compensation expense of $14.0 million for the quarter ended March 31, 2021, compared to $3.8 million for the same quarter in 2020.

Adjusted net loss was $56.8 million, or an adjusted net loss of $0.74 per basic and diluted share, for the quarter ended March 31, 2021, compared to $39.7 million, or an adjusted net loss of $0.78 per basic and diluted share, for the same quarter in 2020. The increase in adjusted net loss was primarily driven by the expansion of the organization, investment in the expanding clinical portfolio and the preparation for the anticipated launch of ZYNLONTA.

Conference Call Details

ADC Therapeutics management will host a conference call and live audio webcast to discuss first quarter 2021 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the live call, please dial 888-771-4371 (domestic) or +1 847-585-4405 (international) and provide confirmation number 50158735. A live webcast of the presentation will be available under "Events and Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.

On May 6, 2021 Isofol Medical AB (publ) ("Isofol"), (Nasdaq First North Premier Growth Market: ISOFOL) reported its primary recruitment objective with the recruitment of 440 patients in the global phase III AGENT study (Press release, Isofol Medical, MAY 6, 2021, View Source [SID1234579419]). Today the company announces that it has completed the recruitment of Japanese patients in accordance with the regulatory requirements by the PMDA (the Japanese Medicines Agency) to reach market approval in Japan. As previously communicated, Isofol expects the top line results for the AGENT study to be available during H1 2022.

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Following today’s announcement of the completion of recruitment of Japanese patients, the full patient population, including the entire Japanese cohort, will be included in PMDA’s assessment for a potential market approval in Japan. For a market approval in Japan, the PMDA set a specific requirement for the number of participating Japanese patients of a total of 56 Japanese patients (of which 14 Japanese patients were already included in the primary recruitment of 440 patients) in the AGENT study. The rationale for the specific requirement from PMDA is e.g. that the metabolism of Japanese patients tends to differ from patients in other countries, which is why the effect and potential side effects must be investigated separately.

For the rest of the world, the original 440 patients will be analyzed for efficacy, but the full patient population will be analyzed for safety purposes.

"I am satisfied that we now have completed the recruitment of the Japanese patients, an important step on the way to receive market approval in Japan, the second largest oncology market worldwide. We are now looking forward to continue working with Solasia on the development and registration of arfolitixorin to bring a new treatment option to patients living with mCRC in Japan", said Ulf Jungnelius, M.D, CEO of Isofol.

Solasia Pharma ("Solasia") will fund and supervise clinical development activities in Japan and will be responsible for registrational filing, and following potential regulatory approvals, Solasia will, as the Market Authorization holder, be responsible for the commercialization of arfolitixorin in Japan. Isofol remain the global sponsor of the AGENT study.

"We are very pleased to have completed the recruitment of the target number of patients in Japan in the AGENT study and contributed to the global development of arfolitixorin. I would like to thank all the patients and investigators participating in the study, the CRO in charge of conducting the study, and Isofol, our partner and the sponsor of the AGENT study, for supporting us achieve this important goal. Patient recruitment was completed earlier than expected, and Solasia, together with Isofol, will further proceed development of arfolitixorin for market approval in Japan with the aim of becoming a new treatment option for mCRC patients", said Yoshihiro Arai, President & CEO of Solasia.

Arfolitixorin is evaluated in the AGENT study for the treatment of patients with first-line metastatic colorectal cancer (mCRC). The study is currently being conducted in the U.S., Canada, Europe, Australia and Japan in more than 90 clinics.

The information was submitted for publication, through the agency of the contact person set out above, at 08:30 CET on May 6, 2021.

About the AGENT study

The Phase III AGENT study is a randomized, controlled, multi-centre study assessing the efficacy and safety of arfolitixorin, [6R]-5,10-methylene-THF acid (MTHF), compared to leucovorin, both used in combination with 5- FU, oxaliplatin, and bevacizumab, in first-line metastatic colorectal cancer patients. Patients are randomized in a 1:1 ratio and the primary endpoint is overall response rate (ORR). The key secondary endpoints are progression free survival (PFS) and duration of response (DOR). Other secondary endpoints include overall survival (OS), number of curative metastasis resections, safety, and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK) measurements and level of gene expression of folate relevant genes in tumour cells. The study is designed to show superiority for arfolitixorin over leucovorin. The study is ongoing at approximately 90 sites in the U.S., Canada, Europe, Australia and Japan. In December 2020, the last of the AGENT study’s 440 patients was recruited, which is the basis in the statistical analysis plan. Recruitment has since continued in Japan to reach 56 Japanese patients. Isofol is now focusing on completing the ongoing AGENT study where the patients receive first-line standard treatment for metastatic colorectal cancer (mCRC). The company expects that the results of the AGENT study will be available during H1 2022.Further information about the study, including patient eligibility requirements, is available at www.clinicaltrials.gov id: NCT03750786.

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit more patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

On May 6, 2021 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported first quarter financial results for the period ended March 31, 2021 and provided an update on recent company developments (Press release, SpringWorks Therapeutics, MAY 6, 2021, View Source [SID1234579442]).

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"In the first quarter of 2021 we continued to execute on our 10 clinical programs and grew our portfolio of opportunities aimed at serving a broad group of patients across our three distinct oncology segments: late-stage rare oncology, hematological cancers and biomarker-defined metastatic solid tumors," said Saqib Islam, Chief Executive Officer of SpringWorks. "We are poised for multiple important data readouts this year, including topline data from our Phase 3 DeFi trial, initial clinical data from our BCMA combination trial of nirogacestat with GSK’s BLENREP in multiple myeloma and initial clinical data from our metastatic solid tumor trials being conducted in collaboration with BeiGene. I look forward to reporting on our continued progress throughout 2021."

Recent Business Highlights and Upcoming Milestones

Late-Stage Rare Oncology

In February 2021, SpringWorks reported interim data from the adult stratum of the ongoing potentially registrational Phase 2b ReNeu trial evaluating mirdametinib in pediatric and adult patients with NF1-associated plexiform neurofibromas. Of the first 20 adult patients enrolled, 50% had achieved an objective response, the primary endpoint of the study, as assessed by blinded independent central review, and 16 of these 20 patients (80%) remained on study as of the January 22, 2021 data cutoff. In addition, mirdametinib was generally well tolerated, with the majority of treatment-related adverse events (TRAE) being Grade 1 or 2 and only one Grade 3 TRAE reported; there have been no Grade 4 or 5 TRAEs reported. The Company expects to report additional clinical data from the ReNeu trial at a medical conference this year and to complete enrollment of the trial in the second half of 2021.
SpringWorks expects to report topline data from the Phase 3 DeFi trial in the second half of 2021, as previously disclosed.
Recruitment is ongoing in a Phase 2 study sponsored by the Children’s Oncology Group evaluating nirogacestat in pediatric patients with desmoid tumors.
B-cell Maturation Antigen (BCMA) Combinations in Multiple Myeloma

Enrollment is ongoing in three Phase 1 studies evaluating nirogacestat in combination with anti-B-cell maturation antigen (BCMA) therapies in adult patients with relapsed or refractory multiple myeloma: a Phase 1b trial sponsored by GSK evaluating nirogacestat in combination with BLENREP (belantamab mafodotin-blmf), a Phase 1 study sponsored by Allogene evaluating nirogacestat in combination with ALLO-715, and a Phase 1 study sponsored by Janssen Research & Development, LLC (Janssen) evaluating nirogacestat in combination with teclistamab. Initial data from the GSK-sponsored study are expected in 2021. SpringWorks also expects that two additional collaborator-sponsored trials will initiate in the first half of 2021, as previously disclosed: nirogacestat + Pfizer’s elranatamab and nirogacestat + Precision Biosciences’ PBCAR269A.
In March 2021, SpringWorks entered into a services agreement with ONCOtracker, Inc., a leading innovation center for novel cancer treatment and testing with a focus on the diagnosis and treatment of multiple myeloma, other B-cell malignancies, and related disorders, to explore the effect of nirogacestat on soluble BCMA release and membrane-bound BCMA receptor density in primary bone marrow samples collected from multiple myeloma patients. This research is intended to further confirm nirogacestat’s ability to potentiate BCMA by using ex vivo patient-derived models with associated longitudinal clinical characterization for each sample.
Biomarker-Defined Metastatic Solid Tumors

In May 2021, SpringWorks entered into an exclusive worldwide license agreement with Katholieke Universiteit Leuven (KU Leuven) and the Flanders Institute for Biotechnology (VIB) for the in-license of a portfolio of novel small molecule inhibitors of the TEA Domain (TEAD) family of transcription factors, designed for the potential treatment of biomarker-defined solid tumors driven by aberrant Hippo pathway signaling. The licensed portfolio includes advanced lead compounds and multiple backup compounds from diverse chemical series, which were discovered at KU Leuven’s Center for Drug Design and Discovery (CD3) in collaboration with Professor Georg Halder of the VIB-KU Leuven Center for Cancer Biology. SpringWorks expects to nominate a development candidate from this portfolio and move into IND-enabling studies in 2022.
Enrollment is ongoing in a Phase 1b/2 trial evaluating mirdametinib with BeiGene’s RAF dimer inhibitor, lifirafenib, in adult patients with RAS/RAF mutant and other MAPK pathway aberrant solid tumors. BeiGene is sponsoring this trial and SpringWorks and BeiGene expect to report initial clinical data in 2021, as previously disclosed.
Enrollment is ongoing in a Phase 1 trial of BGB-3245 in adult patients with RAF mutant solid tumors. BGB-3245 is a selective RAF dimer inhibitor being developed by MapKure, LLC, a joint venture between SpringWorks and BeiGene. Initial clinical data from the MapKure-sponsored Phase 1 trial are expected in 2021, as previously disclosed.
In March 2021, SpringWorks entered into a research collaboration agreement with Inserm Transfert, the private subsidiary of Inserm, acting as a delegatee of the French National Institute of Health and Medical Research (Inserm) to explore the ability of nirogacestat to delay the development of resistance to the EGFR inhibitor osimertinib in preclinical models of non-small cell lung cancer (NSCLC) driven by the EGFR C797S gatekeeper mutation. This research, which will be led by Antonio Maraver, Ph.D. at Montpellier Cancer Research Institute (IRCM U1194), is intended to build on previous in vivo work from Dr. Maraver’s lab demonstrating the potential for gamma secretase inhibition to enhance the activity of osimertinib in EGFR-driven models of NSCLC.1
General Corporate

In March 2021, Bhavesh Ashar was appointed Chief Commercial Officer of SpringWorks. Mr. Ashar has more than 20 years of global pharmaceutical and biotechnology experience, most recently having served as Senior Vice President, General Manager of U.S. Oncology at Bayer Healthcare where he was responsible for a broad portfolio in prostate, liver, colorectal, GIST, hematologic and tumor-agnostic biomarker driven cancers.
First Quarter 2021 Financial Results

Research and Development (R&D) Expenses: R&D expenses were $17.4 million for the first quarter, compared to $9.7 million for the comparable period of 2020. The increases in R&D expenses were primarily attributable to an increase in external costs related to drug manufacturing and trial costs, and an increase in internal costs driven by the growth in employee costs associated with increases in the number of R&D personnel and an increase in stock-based compensation expense.
General and Administrative (G&A) Expenses: G&A expenses were $12.4 million for the first quarter, compared to $6.4 million for the comparable period of 2020. The increases in G&A expenses were primarily attributable to the hiring of additional personnel in G&A functions supporting the growth of the organization, as well as an increase in stock-based compensation expense.
Net Loss Attributable to Common Stockholders: SpringWorks reported net loss of $29.8 million, or $0.62 per share, for the first quarter of 2021. This compares to a net loss of $15.3 million, or $0.37 per share, for the comparable period of 2020.
Cash Position: Cash, cash equivalents and marketable securities were $541.0 million as of March 31, 2021.
COVID-19 Update

To date, the COVID-19 pandemic has had a relatively modest impact on SpringWorks’ business operations, in particular on SpringWorks’ clinical trial programs, and SpringWorks is undertaking considerable efforts to mitigate the various challenges presented by this crisis. For further details and descriptions of the risks associated with the COVID-19 pandemic, please see the Risk Factors in SpringWorks’ periodic filings with the Securities and Exchange Commission and refer to the Forward-Looking Statements section in this press release.

On May 6, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported that its Board of Directors has decided to pay a dividend of $0.32 per share for the quarter ended March 31, 2021 (Press release, Bio-Techne, MAY 6, 2021, View Source [SID1234579265]). The quarterly dividend will be payable May 28, 2021 to all common shareholders of record on May 17, 2021. Future cash dividends will be considered by the Board of Directors on a quarterly basis.

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On May 6, 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 first quarter 2021 financial results and corporate updates (Press release, Iovance Biotherapeutics, MAY 6, 2021, View Source [SID1234579337]).

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Maria Fardis, Ph.D., President and Chief Executive Officer of Iovance, stated, "During the first quarter of 2021 we continued to work on our potency assays in support of a BLA for lifileucel, which is our top priority at Iovance. We continued developing multiple assays in parallel and submitted additional potency assay data to the FDA. I am also very pleased to highlight the strength of clinical data for TIL being presented at the recent and upcoming medical meetings and journal publications, including the first clinical data for TIL in combination with pembrolizumab in melanoma at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting. We believe durable responses for Iovance TIL in relapsed or refractory metastatic melanoma, paired with data to be presented for TIL in combination with anti-PD1 therapy in earlier treatment settings, solidify the broader potential for Iovance TIL and further demonstrate our leadership in the development, manufacturing, and potential commercialization of TIL cell therapy."

First Quarter 2021 Highlights and Recent Corporate Updates

Clinical:

TIL therapy, lifileucel, in melanoma: Updated data from Cohort 2 in the C-144-01 study of lifileucel in advanced melanoma were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting. As of the December 2020 data cutoff for the presentation, lifileucel showed a 36.4% overall response rate (4.5% complete responses and 31.8% partial responses); median duration of response (DOR) was not reached at 28.1 months of median study follow up as assessed by investigators (n=66). Available care for Cohort 2 patients is chemotherapy, with an overall response rate of four to 10 percent and overall survival of only seven to eight months. Updated Cohort 2 data has been accepted for an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. A manuscript of the Cohort 2 data has also been accepted for a forthcoming publication in a high impact oncology journal.
TIL therapy, lifileucel, in cervical cancer: The C-145-04 study of lifileucel, formerly LN-145, is intended to support a BLA submission for metastatic cervical cancer. Inclusion of both pivotal cohort 1 (post-chemotherapy) and cohort 2 (post-anti-PD-1/PDL-1) in the BLA may strengthen the potential label and reflect the expected upcoming treatment landscape in cervical cancer. Patient dosing is complete in both Cohorts 1 and 2, and enrollment continues in Cohort 3 (lifileucel in combination with pembrolizumab in cervical cancer patients who are naïve to anti-PD-1 therapy).
TIL therapy in non-small cell lung cancer (NSCLC): Iovance has activated 10 U.S. clinical sites and patients have consented in 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). The company also continues to investigate LN-145 in several additional NSCLC populations with unmet need across three cohorts in the IOV-COM-202 basket study.
TIL therapy in combination with pembrolizumab in melanoma and head and neck squamous cell carcinoma (HNSCC): Iovance is investigating TIL in combination with pembrolizumab in earlier treatment settings in melanoma and HNSCC. Initial data from Cohort 1A in the IOV-COM-202 study, which is evaluating lifileucel in combination with pembrolizumab in melanoma, will be presented at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting. Patients with HNSCC continue to enroll in the expanded Cohort 2A in the IOV-COM-202 study to receive LN-145 in combination with pembrolizumab.
TIL clinical program updates: To date, over 450 patients have been dosed with Iovance TIL products with more than a 90 percent manufacturing success rate.
Regulatory

Potency assays for lifileucel: Iovance recently submitted additional potency assay data to the FDA, while continuing to evaluate additional assays as backup options in support of the BLA. Submission of the BLA is anticipated during 2021. Expeditious resolution of the potency assay for lifileucel in melanoma is also a key step towards BLA submission plans in cervical cancer.
Manufacturing:

Iovance Cell Therapy Center (iCTC): Activities at the iCTC have commenced to support start of clinical manufacturing in late 2021. The expected commercial manufacturing remains on track to start in 2022.
Generation 3 (Gen 3) manufacturing: A shorter 16-day third generation manufacturing process is being explored in a cohort of metastatic melanoma patients in the IOV-COM-202, where patient dosing has initiated using Gen 3. In addition, a cohort of NSCLC patients in the IOV-LUN-202 study will receive product manufactured by this Gen 3 process.
Corporate:

Cash position of $610.2 million on March 31, 2021 is expected to be sufficient into 2023 to deliver on pipeline programs.
A strong organization of more than 250 employees, of which 76 percent have more than a year of cell therapy experience, is in place to advance research, development, manufacturing, and commercial launch preparations.
On May 6, 2021, Iovance entered into an amended license agreement with the National Institutes of Health (NIH), which adds additional exclusive, worldwide patent rights in certain indications to cytokine-tethered TIL technology and expands the non-exclusive, worldwide field of use to all cancers.
Iovance continues to expand its intellectual property portfolio and currently owns more than 25 granted or allowed U.S. and international patents for compositions and methods of treatment in a broad range of cancers relating to the Gen 2 manufacturing process. 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.
First Quarter 2021 Financial Results

Iovance held $610.2 million in cash, cash equivalents, investments and restricted cash at March 31, 2021 compared to $635.0 million at December 31, 2020. The company anticipates that the year-end balance of cash, cash equivalents, investments and restricted cash will be sufficient into 2023.

Jean-Marc Bellemin, Chief Financial Officer, stated, "The continued strength of our balance sheet puts Iovance in an excellent position to fulfill our operating plan and advance our pipeline. We are judicious in our investments to maximize value and deliver on our commitments for patients and our shareholders."

Net loss for the first quarter ended March 31, 2021, was $75.4 million, or $0.51 per share, compared to a net loss of $69.6 million, or $0.55 per share, for the first quarter ended March 31, 2020.

Research and development expenses were $55.9 million for the first quarter ended March 31, 2021, a decrease of $1.0 million compared to $57.0 million for the first quarter ended March 31, 2020.

The decrease in research and development expenses in the first quarter 2020 over the prior year period was primarily attributable to a decrease in manufacturing and clinical costs following the completion of enrollment in the pivotal cohorts for melanoma and cervical cancer.

General and administrative expenses were $19.6 million for the first quarter ended March 31, 2021, an increase of $5.8 million compared to $13.9 million for the first quarter ended March 31, 2020.

The increases in general and administrative expenses in the first quarter 2021 compared to the prior year period was 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 first quarter 2021 financial results and corporate updates. The conference call dial-in numbers are 1-800-773-2954 (domestic) or 1-847-413-3731 (international) and the access code is 50155289. 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.