On April 25, 2022 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer cell therapies to treat cancer, reported positive preliminary Phase 1 data from independent dose finding studies of its two lead chimeric antigen receptor (CAR) natural killer (NK) cell therapy candidates, NKX101 and NKX019, in two distinct groups of hematologic malignancies (Press release, Nkarta, APR 25, 2022, View Source [SID1234612903]).

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"We’re excited to see our CAR NK co-lead candidates, NKX101 and NKX019, show such striking early single-agent activity in heavily pretreated patient populations, with an exceptional safety profile without the side effects associated with CAR T cell therapies," said Paul J. Hastings, President and CEO of Nkarta. "These encouraging data across multiple indications further validate Nkarta’s best-in-class NK cell platform, as we seek to transform cancer treatment by bringing together the safety advantages of NK cells with an off-the-shelf modality designed to make the benefits of cell therapy accessible in a community setting."

In the first trial, evaluating NKX101, in relapsed / refractory (r/r) acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), three of five patients with heavily pre-treated AML who received the higher dose level in a three-dose regimen achieved a complete response (60% CR) with hematologic recovery, with two of the three responses MRD (minimal residual disease) negative. There is currently no standard of care for these patients.

In the second trial, evaluating NKX019, in r/r B cell malignancies, three of six patients treated at the higher dose level in a three-dose regimen showed a complete response (50% CR), including one patient with aggressive diffuse large B cell lymphoma (DLBCL) and one patient with mantle cell lymphoma (MCL). In both trials, no dose limiting toxicity was observed and there were no CAR T like adverse events of any grade.

Nkarta continues to enroll patients in three-dose regimens of 1.5 billion NK cells per dose in the dose finding portions of the NKX101 and NKX019 trials. Data from both programs, including additional follow-up and updates on the higher dose cohorts, will be submitted for presentation at a future medical meeting.

Evaluating NKX101 in r/r acute myeloid leukemia
NKX101 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses NK cells engineered to target NKG2D ligands on cancer cells. NKX101 is being evaluated in a dose-escalation Phase 1 study as a multi-dose, multi-cycle monotherapy in patients with r/r AML and higher-risk MDS.

As of April 21, 2022, 21 patients were enrolled and dosed, 17 with a diagnosis of AML and four with MDS. Patients were heavily pre-treated and had received a median of three prior lines of therapy (range of 1 to 12). All patients with AML had received prior treatment with venetoclax. At baseline, the median percentage of blast cells in bone marrow was 27% (range of 3 to 85%).

"Relapsed/refractory acute myeloid leukemia (AML) is a historically hard-to-treat disease, and given the lack of effective treatments, people with cancer and those who treat them are faced with few options," said Marcello Rotta, M.D., Colorado Blood Cancer Institute (CBCI), a part of the Sarah Cannon Cancer Institute at Presbyterian/St. Luke’s Medical Center, and investigator in the NKX101 clinical trial. "Complete responses with corresponding MRD negativity in r/r AML using engineered NK cells, as seen in these preliminary findings, is encouraging. We look forward to leading further investigation to better understand the full potential of a CAR NK approach."

Safety in NKX101
NKX101 was well tolerated. No dose-limiting toxicities were observed. Toxicities associated with engineered chimeric antigen receptor (CAR) T cell treatments were not observed at any dose, including cytokine release syndrome, graft-versus-host disease, and immune effector cell-associated neurotoxicity (ICANS). The most common higher-grade adverse events were myelosuppression – a condition resulting in fewer red blood cells, white blood cells and platelets, and infection, which are common in this patient population post lymphodepletion. Two patients experienced Grade 2 infusion reactions, transient fever and fluid responsive hypotension. (See table 1.) The emerging safety profile of NKX101 is positively differentiated from those of many cell therapies.

Treatment emergent adverse events regardless of relationship based on interim data from open clinical database as of 21 Apr 2022 ​
^ In the setting of febrile neutropenia/pneumonia
Clinical Activity in NKX101
Twenty-one patients who received NKX101 were assessed (See table 2.) In the two highest dose-level cohorts (3 doses of 1 billion cells or 3 doses of 1.5 billion cells), 3 of 5 patients with AML achieved a complete response (60% CR) with hematologic recovery. Two of the 3 reported complete responses were MRD (minimal residual disease) negative. MRD negativity is broadly viewed as an important quantitative measure of disease burden in AML and is associated with increased disease-free survival and decreased risk of recurrence. For all cohorts in the dose finding portion, 8 of 17 patients with AML achieved an overall response (47% ORR) and 3 of 17 achieved a complete response with hematologic recovery (18% CR). Four patients with MDS were treated, with no response observed.

NKX019 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses NK cells engineered to target the B-cell antigen CD19, a clinically validated target for B-cell cancer therapies. The NKX019 Phase 1 study is evaluating the safety and anti-tumor activity of NKX019 as a multi-dose, multi-cycle monotherapy in patients with r/r B cell malignancies.

As of April 21, 2022, 13 patients were enrolled and dosed. Ten patients entered the study with a diagnosis of non-Hodgkin lymphoma (NHL), 5 of which were aggressive large B cell lymphoma (LBCL). Patients had received a median of 4 prior lines of therapy (range of 2 to 7). To date, enrollment has included patients with aggressive disease presentations and extensive lesions throughout the body. Patients were enrolled at clinical trial sites in Australia (10) and the United States (3).

"The curative potential of CAR T cell therapy is truly remarkable, but many eligible patients are still not cured, and the safety and logistical challenges of approved autologous CAR T therapy are barriers," said Michael Dickinson, M.D., Lead, Aggressive Lymphoma disease group, Clinical Haematology, Peter MacCallum Cancer Centre and Royal Melbourne Hospital, and investigator in the NKX019 trial. "The NKX019 trial exemplifies the continued progress of our field. NKX019 showed clear activity, in patients with a range of NHL histologies, without the sort of toxicities expected of other cellular therapies, supporting continued exploration of this CAR NK candidate."

Safety in NKX019
NKX019 was well tolerated. No dose-limiting toxicities were observed. Toxicities associated with CAR T cell treatments were not observed at any dose, including cytokine release syndrome, graft-versus-host disease, and ICANS. The most common higher-grade adverse events were myelosuppression – a condition resulting in fewer red blood cells, white blood cells and platelets, which is common in this patient population post lymphodepletion. (See table 3.) One patient experienced Grade 1 infusion reactions. The emerging safety profile of NKX019 is positively differentiated from those of many cell therapies.

Treatment emergent adverse events regardless of relationship based on interim data from open clinical database as of 21 Apr 2022 ​

Clinical Activity in NXK019
Thirteen patients who received NKX019 were assessed. (See table 4.) Five of 6 patients with NHL in the cohort receiving 3 doses of 1 billion cells achieved a response (83% ORR), and 3 of 6 achieved a complete response (50% CR rate). For all cohorts in the dose finding portion, 7 of 10 evaluable patients with NHL achieved an objective response (70% ORR) and 4 of 10 achieved a complete response (40% CR). Three patients with ALL were treated, with no response observed.

NXK019 Clinical Activity (Table 4)

NKX101 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses natural killer (NK) cells engineered to target NKG2D ligands on cancer cells. The dose-finding portion of the NKX101 Phase 1 study evaluates the safety and anti-tumor activity of NKX101 as a multi-dose, multi-cycle monotherapy following lymphodepletion in patients with r/r AML and higher-risk MDS. Patients must have received at least one prior therapy, and patients diagnosed with a disease mutation must have received a targeted therapy, where approved.

Patients in the NKX101 Phase 1 trial received a cycle of treatment consisting of fludarabine/ cyclophosphamide lymphodepletion followed by either a three-dose regimen where NKX101 cells were given on Days 0, 7, and 14; or a two-dose regimen where the cells were given on Days 0 and 7. Patients received doses of 100 million, 300 million, 1 billion or 1.5 billion NK cells three times in the 3-dose regimen, or doses of 150 million, 450 million or 1.5 billion NK cells two times in the 2-dose regimen. Based on tumor response and tolerability assessment, patients were eligible to receive additional treatment cycles. Disease assessment was performed by investigator review according to the ELN response criteria for patients with AML and Cheson response criteria for patients with MDS.

About the NKX019 Trial
NKX019 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses natural killer (NK) cells engineered to target the B-cell antigen CD19, a clinically validated target for B-cell cancer therapies. The dose-finding portion of the NKX019 Phase 1 study evaluates the safety and anti-tumor activity of NKX019 as a multi-dose, multi-cycle monotherapy following lymphodepletion in patients with r/r B cell malignancies. Patients must have received at least two prior therapies. Patients who received prior autologous CAR-T therapy were not eligible.

Patients in the NKX019 trial received a cycle of treatment consisting of fludarabine/cyclophosphamide lymphodepletion followed by NKX019 cells in a three-dose regimen where cells were given on Days 0, 7, and 14. Patients received doses of 300 million or 1 billion cells three times in a cycle. Based on tumor response and tolerability assessment, patients were eligible to receive additional treatment cycles. Disease assessment was performed by investigator review according to the 2014 Lugano response criteria for patients with NHL and NCCN response criteria for patients with ALL.

About NKX101
NKX101 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy donors. It is engineered with a chimeric antigen receptor (CAR) targeting NKG2D ligands on tumor cells. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely expressed on cancer cells. NKX101 is also engineered with membrane-bound form of interleukin-15 (IL15) for greater persistence and activity without exogenous cytokine support. To learn more about the NKX101 clinical trial in adults with AML or MDS, please visit ClinicalTrials.gov.

About NKX019
NKX019 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed CAR for enhanced tumor cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal and malignant B cells, and it is a validated target for B cell cancer therapies. To learn more about the NKX019 clinical trial in adults with advanced B cell malignancies, please visit ClinicalTrials.gov.

On April 25, 2022 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported updated interim data from the ongoing Phase 1/2 clinical trial of MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphomas ("B-NHLs") and chronic lymphocytic leukemia ("CLL") (Press release, Mustang Bio, APR 25, 2022, View Source [SID1234612920]). MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center ("Fred Hutch").

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The data, which were presented by Mazyar Shadman, M.D., M.P.H., Associate Professor and physician at Fred Hutch and University of Washington, at the 2022 Tandem Meetings I Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy ("ASTCT") and Center for International Blood & Marrow Transplant Research ("CIBMTR"), demonstrated high efficacy and a very favorable safety profile in all patients (n=25). Five dose levels were used during the study, and complete responses were observed at all dose levels. Durable responses were observed in a wide range of hematologic malignancies including follicular lymphoma ("FL"), CLL, diffuse large B-cell lymphoma ("DLBCL"), and Waldenstrom macroglobulinemia ("WM"). An overall response rate ("ORR") of 96% and complete response ("CR") rate of 72% was observed in all patients across all dose levels. Additionally, two patients had been previously treated with CD19-directed CAR T therapy and subsequently relapsed, and both responded to treatment, one patient with FL with a CR and the other with DLBCL with a partial response.

CAR T expansion was observed across all dose levels. At the 28-day evaluation, a favorable safety profile was observed in all 25 patients. No patients experienced grade 3 or 4 cytokine release syndrome or immune effector cell‐associated neurotoxicity syndrome ("ICANS"), and none of the FL patients experienced ICANS of any grade (n=18).

"We are pleased that in this single institution study, we observed a favorable safety profile and a high rate of complete and durable responses, which make MB-106 suitable for outpatient treatment. Additionally, the responses from patients treated previously with CD19-directed CAR T cell therapy show the potential of MB-106 as an immunotherapy option for these patients. Enrollment in this study remains open to patients with CD20+ B-NHLs and CLL, including patients with prior CAR T treatment," said Dr. Shadman.

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "MB-106 continues to demonstrate highly promising clinical activity. In particular, the 100% response rates of WM patients as well as of NHL patients previously treated with CD19-directed CAR T cell therapy underscore the potential for MB-106 to treat these patient populations with high unmet needs. The possible outpatient administration of this therapy makes it potentially even more compelling. We are excited to advance our CD20-targeted CAR T cell therapy program with the launch of a multicenter Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106 for relapsed or refractory B-NHL and CLL under Mustang’s IND and plan to dose the first patient this quarter."

Scientists at Fred Hutch played a role in developing these discoveries, and Fred Hutch and certain of its scientists may benefit financially from this work in the future.

About MB-106 (CD20-targeted autologous CAR T Cell Therapy)
CD20 is a membrane-embedded surface molecule which plays a role in the differentiation of B-cells into plasma cells. The CAR T was developed by Mustang’s research collaborator, Fred Hutch, in the laboratories of the late Oliver Press, M.D., Ph.D., and Brian Till, M.D., Associate Professor in the Clinical Research Division at Fred Hutch, and exclusively licensed to Mustang in 2017. The lentiviral vector drug substance used to transduce patients’ cells to create the MB-106 drug product produced at Fred Hutch has been optimized as a third-generation CAR derived from a fully human antibody, and MB-106 is currently in a Phase 1/2 open-label, dose-escalation trial at Fred Hutch in patients with B-NHLs and CLL. The same lentiviral vector drug substance produced at Fred Hutch will be used to transduce patients’ cells to create the MB-106 drug product produced at Mustang Bio’s Worcester, MA, cell processing facility for administration in the planned multicenter phase 1/2 clinical trial to be initiated shortly under Mustang Bio’s IND. It should be noted that Mustang Bio has introduced minor improvements to its cell processing to facilitate eventual commercial launch of the product. In addition, prior to commercial launch, Mustang Bio will replace the Fred Hutch lentiviral vector drug substance with vector produced at a commercial manufacturer. Additional information on the trial can be found at View Source using the identifier NCT03277729.

On April 25, 2022 AI Therapeutics, Inc., an AI driven clinical-stage biopharmaceutical company developing novel therapeutics for rare diseases, reported the acquisition of EntreChem, S.L.’s investigational drug candidate EC-8042 (redesignated AIT-102), a novel targeted cancer therapy in development for rare pediatric and other cancers (Press release, EntreChem, APR 25, 2022, View Source [SID1234648560]).

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Despite recent advances in the understanding of tumor biology, treatment for many pediatric cancers remains limited to surgery, radiation and chemotherapy which often have poor outcomes and are associated with significant side effects. AIT-102 specifically targets the mutations responsible for the formation and progression of two notable pediatric tumors, rhabdoid tumors and Ewing sarcoma, and holds the potential to treat a broader family of tumors that share a common mechanism of mutated or dysregulated SWI/SNF activity.

"As a physician treating children with cancer on a daily basis, I am acutely aware of the need for more effective and less toxic therapies," said Patrick Grohar, M.D., Ph.D., Director of Translational Research with the Center of Childhood Cancer Research at Children’s Hospital of Philadelphia, a leader in the study and treatment of pediatric tumors. "For many tumor types, the biological culprit is well understood, but has proven difficult to target with pharmaceuticals. I have dedicated the last 15 years of my professional career to understanding the mechanism of tumor biology in children and finding new, targeted, therapies to treat these tumors. I am particularly impressed with the strong preclinical data from our studies of AIT-102 in rhabdoid tumors and Ewing sarcoma, and I believe that AIT-102 has the potential to transform the treatment of these cancers, as well as many others."

"AIT-102 is a powerful addition to AI Therapeutics’ rare disease treatment pipeline," said Brigette Roberts, M.D., Chief Executive Officer of AI Therapeutics. "Cancer is the leading cause of death by disease in children in the US today. With AIT-102, we hope to change these statistics. Beyond pediatrics, AIT-102 has the potential to treat up to 20% of cancers with altered SWI/SNF activity, either through mutation or dysregulation, including epithelioid sarcoma, synovial sarcoma, lung adenocarcinoma, colorectal cancer, and others. We are thrilled to have this opportunity to bring forward a promising new agent to help fight these tumors."

Financial terms of the transaction were not disclosed.

On April 25, 2022 BioVaxys Technology Corp. (CSE: BIOV, FRA:5LB,OTCQB:BVAXF) ("BioVaxys" or "Company"), reported that it has entered into an agreement with the Deaconess Research Institute ("DRI") to supply BioVaxys with surgically debulked tumors from Stage III/Stage IV ovarian cancer patients undergoing treatment at Deaconess Health System ("Deaconess") (Press release, BioVaxys Technology, APR 25, 2022, View Source [SID1234614613]). DRI, based in Evansville, Indiana, is the clinical studies arm of Deaconess, a premier regional provider of health care services in the United States. Access to ovarian cancer tumor cells is a critical step enabling BioVaxys to validate the manufacturing process for BVX-0918, the Company’s autologous haptenized tumor cell vaccine for late-stage ovarian cancer.

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The standard of care for late-stage ovarian cancer often involves surgically debulking of the tumor mass. The debulked tumor cells will be used to test and validate the tumor collection protocol, cryopackaging, cryopreservation, and supply chain logistics for BVX-0918 bioproduction. Following shipment to BioElpida s.a. ("BioElpida"), the Company’s bioproduction partner in Lyon, France, the tumor cells will then be used for process testing and manufacturing "dry runs" of BVX-0918, a major step leading to the completion of Good Manufacturing Process ("GMP") production, a requirement for the planned Clinical Trial Application ("CTA") with the European Medicines Agency ("EMA"). BioVaxys, together with its EU partner, ProCare Health of Barcelona, Spain, is preparing to launch a Phase I clinical study for BVX-0918 later this year.

BioElpida developed various tests and validation procedures needed to support GMP manufacturing, such as sterility testing for transport, hapten fixation, and cryopreservation solutions, as well as antibody generation, bioburden screening of the haptens, and endotoxin assays; access to debulked tumor means that BioElpida will begin the final stages of the vaccine production protocol and GMP validation. BioVaxys and BioElpida have also designed and fabricated a specialized shipping package which would cryopreserve the tumor sample while in transit from any hospital site to the BioElpida site.

BioVaxys President & Chief Operating Officer Kenneth Kovan says, "Having complied with the regulatory oversight involved in obtaining waste tumor samples, BioVaxys is now able to provide BioElpida with the materials required for finalizing the vaccine production protocol and performing process validation in the lead up to our planned CTA submission to the European regulator."

BioVaxys’ vaccine platform is based on the established immunological concept that modifying surface proteins—whether they are viral or tumor—with haptens makes them more visible to the immune system. This process of haptenization "teaches" a patient’s immune system to recognize and make target proteins more "visible" as foreign, thereby stimulating a T-cell mediated immune response. BioVaxys’ cancer vaccines are created by extracting a patient’s own (autologous) cancer cells, chemically linking with a hapten, and re-injecting them into the patient to induce an immune response to proteins which are otherwise not immunogenic. Haptenization is a well-known and well-studied immunotherapeutic approach to cancer immunotherapy and has been clinically evaluated in both regional and disseminated metastatic tumors.

A first generation single-hapten vaccine invented by BioVaxys Co-Founder and Chief Medical Officer David Berd, MD, achieved positive immunological and clinical results in Phase I and Phase II human trials in over 600 patients with different tumor types, as well as having no observed toxicity in years of clinical study. These studies were conducted under an FDA-reviewed IND. A first generation autologous, haptenized vaccine was also tested by Dr. Berd in women with advanced ovarian cancer who had ceased to respond to conventional chemotherapy. The results were encouraging: In 24 patients, the median overall survival was 25.4 months with a range of 4.5-57.4 months; 8 patients survived for more than 2 years. BioVaxys has enhanced the first-generation approach by utilizing two haptens ("bi-haptenization"), which the Company believes will yield superior results.

On April 25, 2022 Nektar Therapeutics (Nasdaq: NKTR) reported a new strategic plan focused on prioritizing key research and development efforts that will be most impactful to the company’s future, including its NKTR-358, NKTR-255 and several core research programs (Press release, Nektar Therapeutics, APR 25, 2022, View Source [SID1234612904]). In connection with this new strategic plan, Nektar also announced a cost restructuring plan aimed at ensuring Nektar has significant capital to fund key programs through value-enhancing data and other milestones without a need to raise incremental capital for at least 3 years.

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Nektar’s strategic plan going forward is built upon three core pillars:

Success-based development funding of NKTR-358 for maximum royalty participation: In partnership with Eli Lilly, the NKTR-358 program has continued to advance. Built upon early promising data, the Phase 2 program for NKTR-358 includes the ongoing 280-patient Phase 2 study in lupus, a second Phase 2 study planned to start shortly in 300 patients with atopic dermatitis and a third Phase 2 study being planned in a yet to be announced autoimmune indication to potentially start in 2023. Under the terms of its agreement with Eli Lilly, Nektar is eligible for up to $250 million in development and regulatory milestones. Nektar will have the option to participate in Phase 3 development up to 25% on an indication-by-indication basis and can receive significant double-digit royalties on global sales of NKTR-358 with the first tier in the mid-teens and the second tier in the low twenties of global sales of NKTR-358. Lilly is responsible for all costs of global commercialization and Nektar has an option to co-promote NKTR-358.
Prudently develop NKTR-255 in its areas of strength and differentiation: Nektar’s development plan for 255 is focused on key preclinical and emerging clinical data driven areas of differentiation of this unique IL-15 agonist. The company will continue the Merck KGaA-sponsored JAVELIN Bladder Medley Study. In addition, new development efforts will focus on the potential to use NKTR-255 as a cell therapy potentiator, based upon clinical observations and preclinical models suggesting NKTR-255 has great potential to enhance CAR-T cell persistence. Nektar currently has two studies underway with external collaborators to evaluate NKTR-255 in combination with CAR-T therapies and is also currently designing a Nektar-sponsored comparative study, which it aims to initiate in the second half of 2022. The company will also continue its dose-escalation development work in combination with antibody-dependent cell mediated cytotoxicity (ADCC) agents and plans to evaluate potential next steps once these data mature.
Invest in core research programs to complement Nektar’s pipeline: Nektar is currently cultivating several new research programs. The first, a collaboration with Biolojic Design, is for a unique bivalent agonistic antibody targeting TNFR2, and is an example of Nektar’s ability to bring in external candidates and new modalities into the pipeline. The additional two programs were invented in Nektar’s laboratories and are focused in the areas of auto-immune disease and oncology.
"Over the past several weeks, the Nektar executive team has made decisions to prioritize key research and development efforts that will be most impactful to the future of our company," said Howard W. Robin, President and CEO of Nektar. "This new strategic plan focuses on important pipeline programs – NKTR-358, NKTR-255 and preclinical candidates – each of which we believe presents an opportunity to create significant value for our shareholders."

To reflect these new strategic priorities, Nektar also announced several changes to its executive team. Dr. Dimitry Nuyten, Nektar’s Chief Medical Officer (CMO), will step down from his position following a transition through June 2022. He will be succeeded by Dr. Brian Kotzin, Nektar’s Head of Immunology, who brings over 30 years of drug development experience to the role and is an expert in the areas of immunology and inflammatory diseases. Dr. Kotzin had previously served as Nektar’s interim CMO. John Northcott, Nektar’s Chief Commercial Officer, who led the pre-commercialization activities for BEMPEG, will depart the company in June following a transition period, but will remain as a strategic consulting advisor to the company through the end of 2022. The company thanks Dr. Nuyten and Mr. Northcott for their contributions.

Cost Restructuring Plan
Nektar also announced that it is implementing a cost restructuring plan, extending the company’s cash runway into the first half of 2025. The restructuring plan is designed to ensure Nektar has sufficient working capital to fund key R&D programs to value-enhancing data and other milestones without a need to raise external capital. In connection with this restructuring, Nektar will reduce its workforce by approximately 70%. The scale and scope of this reduction aligns with the substantial work Nektar did to conduct late stage registrational studies of bempegaldesleukin and prepare for its widespread distribution and commercial launch.

Robin continued, "Our new operating plan is designed to ensure we have at least three years of cash runway to support the advancement of our key programs through a steady stream of data catalysts that we expect will begin in the second half of 2022. On behalf of our entire Nektar management team and Board, I want to express my deep and humble gratitude to the employees who will be departing Nektar. We are immensely grateful for the contributions you have made to our company, your dedication to our mission and your efforts to work to bring new medicines to patients with debilitating diseases."

After accounting for BEMPEG wind-down and restructuring costs, Nektar now expects to end the year with approximately $440 million to $450 million in cash and investments and no debt on the company’s balance sheet. In connection with the business restructuring and reduction in workforce, Nektar expects to take a charge of between $150 million and $160 million, a substantial portion of which will be recorded in the company’s financial results for the quarter ending June 30, 2022.

Webcast Conference Call for Analysts & Investors
Nektar executives will host an analyst and investor conference call to discuss the new strategic plan and the company’s research and development pipeline beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time on Monday, April 25, 2022.

The press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through May 27, 2022.