On February 21, 2019 Gamida Cell Ltd. (Nasdaq:GMDA), a leading cellular and immune therapeutics company, reported that new data from its NAM-NK and NiCord programs was presented at the 2019 Transplantation & Cellular Therapy (TCT) Meetings of American Society for Blood and Marrow Transplantation and Center for International Blood and Marrow Transplant Research taking place in Houston, Texas (Press release, Gamida Cell, FEB 21, 2019, View Source [SID1234533559]). Data reported from the first 14 patients in the ongoing Phase 1 study of NAM-NK, an investigational, cell-based cancer immunotherapy, in patients with non-Hodgkin lymphoma (NHL) and multiple myeloma (MM) demonstrated that NAM-NK was highly active, with three complete responses observed in patients with NHL and one complete response in a patient with MM. These data, along with additional safety data showing that NAM-NK was generally well tolerated, support continued clinical development. Gamida Cell is planning to initiate a multi-center, Phase 1/2 clinical study of NAM-NK in 2020. NAM-NK cells are natural killer cells that have been expanded using Gamida Cell’s proprietary nicotinamide-based, or NAM, technology.

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"I am encouraged by the emerging clinical profile of NAM-NK, and it is particularly exciting to witness complete responses in this heavily-pretreated patient population. Following treatment, two of the patients who were in complete remission received a bone marrow transplant, which has curative potential," stated M Health Hematologist/Oncologist Veronika Bachanova, M.D., Ph.D., Associate Professor of Medicine, Section Head for Malignant Hematology in the Division of Hematology, Oncology and Transplantation, University of Minnesota Medical School and Masonic Cancer Center member. "I look forward to continuing to evaluate the potential of NAM-NK as the study progresses."

Additionally, data were reported from the ongoing Phase 1/2 study of NiCord, an investigational advanced cell therapy designed to enhance and expand the life-saving benefits of hematopoietic stem cell (bone marrow) transplant, in patients with severe aplastic anemia. In the initial cohort of three patients, all three successfully underwent a stem cell transplant consisting of NiCord plus a haploidentical stem cell graft. The rapid engraftment, sustained hematopoiesis and accelerated immune recovery observed in these patients enable the initiation of a second cohort of patients to be treated with NiCord as a stand-alone graft.

"Data from our NiCord and NAM-NK programs continue to demonstrate the transformative potential of our proprietary nicotinamide-, or NAM-based, cell expansion technology. We are pleased to be at the forefront of exploring NK-therapy, which we believe has potential to advance treatment paradigms for patients just as CAR T therapy provided ground-breaking treatment options for patients," stated Julian Adams, Ph.D., chief executive officer at Gamida Cell. "We are also encouraged by the initial NiCord data in severe aplastic anemia, which supports further exploring a reduced intensity regimen and highlights the potential of NiCord as a bone marrow transplant solution not only for patients with hematologic malignancies but also for patients with severe bone marrow failure disorders. We look forward to continued progress with both programs throughout 2019."

NAM-NK Data in Patients with NHL and MM

The safety and activity of NAM-NK is currently being evaluated in a Phase 1 dose-escalation study. Patients received rituximab (NHL patients) or elotuzumab (MM patients) prior to and after NAM-NK infusion. The presentation, "First-in-Human Phase I Study of Nicotinamide-Expanded Related Donor Natural Killer Cells for the Treatment of Relapsed/Refractory Non-Hodgkin Lymphoma and Multiple Myeloma" (Poster #242), included six patients with NHL and eight patients with MM. All 14 patients were evaluable for safety, and 12 of 14 patients were evaluable for activity (all six NHL patients and six of eight MM patients). The majority of patients were heavily pre-treated and had advanced disease.

Among the six NHL patients, three patients achieved a complete response, one patient achieved a partial response, and two patients experienced progressive disease. Two of the patients who achieved a complete response subsequently received a bone marrow transplant. Among the six MM patients evaluable for activity, one patient achieved a complete response, two patients experienced stable disease, and three patients experienced progressive disease. Activity was observed at all three dose levels evaluated.

NAM-NK was generally well tolerated, with no graft vs. host disease (GvHD), no tumor lysis syndrome and no neurotoxicity syndrome observed. Grade 3 (n = 3) and Grade 4 (n = 1) hematologic adverse events were observed. Non-hematologic adverse events were mostly Grade 1 and Grade 2. There was one case of Grade 3 cytokine release syndrome and one death due to sepsis.

NiCord Data in Patients with Severe Aplastic Anemia

The safety and activity of NiCord in patients with severe aplastic anemia is being evaluated in an ongoing Phase 1/2 study. The presentation, "Ex Vivo Nicotinamide-Expanded (NAM-Expanded) Unrelated Cord Blood Transplantation (UCB) for Refractory Severe Aplastic Anemia Results in Rapid Engraftment and Expedites Immune Recovery" (Poster #295), included data from three severe aplastic anemia patients with severe neutropenia who failed immunosuppressive therapy.

All three patients enrolled in the first cohort were successfully treated with reduced intensity conditioning regimens and underwent a bone marrow transplant consisting of NiCord plus a haploidentical stem cell graft. Engraftment occurred rapidly, with a median neutrophil recovery of 6 days (range: 6-7 days), which was sustained at day 100, and was superior to that observed in a retrospective cohort of 16 patients who received a single unexpanded umbilical cord blood transplant and haploidentical cells using the same conditioning regimen (P = 0.006). At median follow-up of 11 months (range 4-18 months), all three patients who received NiCord were alive and GvHD-free.

Conference Call Information

Gamida Cell will host a conference call and webcast today, Thursday, February 21, 2019, at 8:00 a.m. ET to review the data from its NAM-NK and NiCord programs that are being presented at the 2019 TCT Annual Meeting. A live webcast of the conference call can be accessed in the Investors section of Gamida Cell’s website at View Source To participate in the conference call, please dial 1-866-930-5560 (domestic) or 1-409-216-0605 (international) five minutes prior to start time. The conference ID number is 9462948. An archived version of the webcast will be available on Gamida Cell’s website for 30 days.

About NAM-NK

Gamida Cell applied the capabilities of its NAM-based cell expansion technology to highly functional NK cells to develop NAM-NK, an innate immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. NAM-NK addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. NAM-NK is in Phase 1 development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.1

About NiCord

NiCord, the company’s lead clinical program, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). NiCord is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU. In a Phase 1/2 clinical study, NiCord demonstrated rapid and durable time to engraftment and was generally well-tolerated.2 A Phase 3 study evaluating NiCord in patients with leukemia and lymphoma is ongoing in the U.S., Europe and Asia.3 NiCord is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia.4 The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as NiCord. For more information on clinical trials of NiCord, please visit www.clinicaltrials.gov.

NAM-NK and NiCord are investigational therapies, and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On February 21, 2019 Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for 2018 (Press release, Cytokinetics, FEB 21, 2019, View Source [SID1234533580]). Net loss for 2018 was $106 million, or $1.95 per share, compared to net loss for 2017 of $128 million, or $2.59 per share. Cash, cash equivalents and investments totaled $199 million at December 31, 2018.

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"We had a productive fourth quarter 2018 highlighted by the expansion of our clinical pipeline of muscle-directed investigational medicines and the advancement of our wholly-owned cardiac myosin inhibitor which we are developing for the potential treatment of patients with hypertrophic cardiomyopathies," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "Our progress is continuing with the achievement of key milestones under our partnered programs. Under our collaboration with Amgen, we recently opened METEORIC-HF to enrollment and expect GALACTIC-HF to complete enrollment in the next few months. In that same timeframe, we are also looking forward to results from FORTITUDE-ALS under our collaboration with Astellas. We believe that our pioneering leadership in muscle biology, alongside our partnerships and current financials, position us well for upcoming company milestones."

Recent Highlights

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

Continued enrollment in GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil. Enrollment is nearing 90 percent completion with over 7,000 patients randomized to date having the high-risk profile intended by the trial design. GALACTIC-HF is being conducted by Amgen in collaboration with Cytokinetics.

Opened METEORIC-HF, (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), the second Phase 3 trial of omecamtiv mecarbil. METEORIC-HF is a randomized, placebo-controlled, double-blind, parallel group, multicenter clinical trial designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET) following 20 weeks of treatment. METEORIC-HF is being conducted by Cytokinetics in collaboration with Amgen.
AMG 594 (cardiac troponin activator)

Began dosing in the Phase 1 study of AMG 594 to assess its safety, tolerability, pharmacokinetics and potential to increase cardiac function in healthy volunteers. AMG 594 is a novel, selective, oral, small molecule cardiac troponin activator, discovered under a joint research program with Amgen. This Phase 1 study is being conducted by Amgen in collaboration with Cytokinetics.
CK-3773274 (CK-274, cardiac myosin inhibitor)

Continued enrollment in a Phase 1 double-blind, randomized, placebo-controlled, multi-part, single and multiple ascending dose clinical study of CK-274 in healthy adult subjects. CK-274 is a wholly-owned, novel cardiac myosin inhibitor, discovered by company scientists, in development for the potential treatment of hypertrophic cardiomyopathy (HCM).
Skeletal Muscle Program

reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))

Received feedback from the U.S. Food and Drug Administration that the Six Minute Walk Test is an acceptable primary endpoint for a potential registration program for reldesemtiv in ambulatory patients with SMA.

Completed patient enrollment in FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS), the Phase 2 clinical trial designed to assess the change from baseline in the percent predicted slow vital capacity and other measures of skeletal muscle function after 12 weeks of treatment with reldesemtiv in patients with ALS. This Phase 2 trial is being conducted by Cytokinetics in collaboration with Astellas.

Announced data from FORTITUDE-ALS at the 29th International Symposium on ALS/MND in Glasgow, Scotland, UK, including patient baseline characteristics and demographics. Baseline characteristics of patients enrolled in FORTITUDE-ALS are similar to those of other recent large clinical trials in ALS, including BENEFIT-ALS and VITALITY-ALS.
Pre-Clinical Development and Ongoing Research

Continued pre-clinical development of CK-3762601 (CK-601), a next-generation FSTA, under our collaboration with Astellas.

Continued research in collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators; The companies are continuing their joint research program with Astellas providing sponsorship of Cytokinetics’ activities through 2019.

Continued independent research activities directed to our other muscle biology research programs.
Corporate

Convened an R&D Day to provide an update on our expanded pipeline of muscle-directed drug candidates.
Financials

Revenues for 2018 included $29.4 million in revenue from our collaboration with Astellas and $1.9 million from our collaboration with Amgen. Revenues from Astellas in 2018 included $22.3 million for reimbursement of research and development expenses, $5.1 million in license revenue and $2.0 million in a milestone payment. Revenues from Amgen in 2018 include $1.9 million for reimbursement of research and development expenses. Revenues for 2017 were offset by $20.0 million for payments to Amgen related to our option to co-fund the Phase 3 development program of omecamtiv mecarbil in exchange for an increased royalty upon potential commercialization.

Research and development expenses decreased to $89.1 million in 2018 from $90.3 million in 2017, primarily due to the suspension of development of tirasemtiv in late 2017, offset in part by increased development activities for reldesemtiv and CK-274.

General and administrative expenses decreased to $31.3 million in 2018 from $36.5 million in 2017, primarily due to decreased commercial readiness activities.

2019 Financial Guidance

The company also announced financial guidance for 2019. The company anticipates cash revenue will be in the range of $28 to $32 million, operating expenses will be in the range of $110 to $115 million, and net cash utilization will be approximately $85 to $90 million.

2019 Corporate Milestones

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

Expect to complete patient enrollment in GALACTIC-HF in the first half of 2019.

Expect the Data Monitoring Committee to conduct a first interim analysis for GALACTIC-HF, the design of which is tied to the potential for futility, in the first half of 2019.

Expect to continue patient enrollment in METEORIC-HF through 2019.
AMG 594 (cardiac troponin activator)

Expect the continued conduct of the Phase 1 study of AMG 594 through 2019.
CK-3773274 (CK-274, cardiac myosin inhibitor)

Expect data from a Phase 1 study of CK-274 in the second half of 2019.
Skeletal Muscle Program

reldesemtiv (next-generation FSTA)

Expect results from FORTITUDE-ALS in Q2 2019.
Pre-Clinical Research

Expect to continue joint research program with Astellas through 2019.

Expect to continue independent research activities directed to our other muscle biology research programs through 2019.
Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s fourth quarter 2018 results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 9798766.

An archived replay of the webcast will be available via Cytokinetics’ website until February 28, 2019. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 9798766 from February 21, 2019 at 7:30 PM Eastern Time until February 28, 2019.

On February 21, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported financial results for the fourth quarter and full year ended December 31, 2018 and provided an update on recent corporate activities (Press release, Halozyme, FEB 21, 2019, View Source [SID1234533533]).

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"Our latest collaboration with argenx demonstrates the broad applicability of our ENHANZE drug delivery technology and is a great way to start the year," said Dr. Helen Torley, president and chief executive officer. "We anticipate multiple additional key milestones in our ENHANZE business including potential approval of Herceptin SC later this quarter and potential regulatory submissions for a subcutaneous formulation of Darzalex in the second half of the year. With a total of nine ENHANZE collaborations spanning from established products to new, innovative therapies addressing unmet needs, we remain confident in the potential for $1 billion in royalty revenue in 2027."

"Our PEGPH20 oncology program achieved a critical milestone during the fourth quarter with the completion of enrollment in our pivotal HALO-301 pancreas cancer study with approximately 500 patients. We also reached agreement with the FDA to change the primary endpoint for HALO-301 to a single primary endpoint of overall survival (OS), which we believe incrementally de-risked the study. We look forward with excitement to topline results from HALO-301, which we currently project in the second half of 2019."

Fourth Quarter 2018 and Recent Highlights Include:

In February 2019, Halozyme licensed its ENHANZE drug delivery technology to argenx providing exclusive access to ENHANZE for any product targeting the human neonatal Fc receptor FcRn, including argenx’s lead asset efgartigimod (ARGX-113), and up to two additional targets. Under the terms of the agreement, argenx paid an upfront payment of $30 million to Halozyme, and will pay Halozyme $10 million per target for future target nominations and potential future payments of up to $160 million per selected target subject to achievement of specified development, regulatory and sales-based milestones. Halozyme will also receive mid-single digit royalties on sales of commercialized products.

In January 2019, the U.S. Food and Drug Administration completed its review of the submitted clinical study protocol amendment and statistical analysis plan for HALO-301, which included a change in the primary endpoint to a single primary endpoint of overall survival (OS), with no additional questions or comments.

In December, enrollment in HALO-301, the company’s Phase 3 study evaluating PEGPH20 in metastatic pancreas cancer, was completed with approximately 500 subjects enrolled. The company projects the study will achieve its target of 330 OS events between August and November of 2019. Based on achieving this timeline, the company projects topline results will be available in the second half of 2019.

In December, Roche dosed the first patient in a Phase 1b/2 study of Tecentriq (atezolizumab) with ENHANZE triggering a $5 million milestone payment to Halozyme.

During the fourth quarter, BMS began recruitment for a Phase 1 study of OPDIVO (nivolumab) with ENHANZE.

ENHANZE partner Janssen continued to make progress in clinical studies for a subcutaneous co-formulation of Darzalex (daratumumab) with the recent initiation of two additional Phase 3 trials. Janssen is planning regulatory filings in the second half of 2019.

In October, Halozyme expanded its collaboration with Roche by licensing its ENHANZE drug-delivery technology for exclusive development of a new undisclosed clinical stage therapeutic target resulting in an upfront payment of $25 million.

Fourth Quarter and Full Year 2018 Financial Highlights

Revenue for the fourth quarter was $60.2 million compared to $189.6 million for the fourth quarter of 2017. The year-over-year decrease was driven by $141.4 million upfront license fees for the BMS and Alexion agreements and a $15.0 million milestone payment from Janssen recognized in 2017, compared to $30.0 million in upfront and milestone revenue for the Roche collaboration recognized in 2018. The decrease was offset by a 9 percent growth in royalties on a reported basis from partner sales. Revenue for the fourth quarter included $19.3 million in royalties and $4.2 million in HYLENEX recombinant (hyaluronidase human injection) product sales.
Revenue for the full year was $151.9 million, compared to $316.6 million in 2017.
Revenue from royalties for the full year was $79.0 million, up 24% on an as-reported basis compared to $63.5 million in 2017.

Research and development expenses for the fourth quarter were $36.7 million, compared to $41.4 million for the fourth quarter of 2017.
Research and development expenses for the full year were $150.3 million, compared to $150.6 million in 2017.

Selling, general and administrative expenses for the fourth quarter were $18.0 million, compared to $14.8 million for the fourth quarter of 2017.
Selling, general and administrative expenses for 2018 were $60.8 million, compared to $53.8 million in 2017.

Net loss for the fourth quarter was $2.1 million, or $0.01 per share, compared to net income in the fourth quarter of 2017 of $123.9 million, or $0.85 per share.
Net loss for the full year was $80.3 million, or $0.56 per share, compared to net income of $63.0 million in 2017, or $0.45 per share.

Cash, cash equivalents and marketable securities were $354.5 million at December 31, 2018, compared to $469.2 million at December 31, 2017.

Financial Outlook for 2019

Halozyme updated its 2019 financial guidance, first provided on January 9, 2019, to reflect the recent argenx collaboration and license agreement:

Net revenue of $205 million to $215 million, excluding revenue from any additional, new ENHANZE global collaboration and licensing agreements;

Operating expenses of $265 million to $275 million, or $225 million to $235 million excluding an expected increase in cost of goods sold. Excluding the cost of goods sold the modest increase in expenses is driven by ENHANZE partner support, and support of the potential commercialization of PEGPH20;

Operating cash burn of $45 million to $55 million;

Debt repayment of approximately $90 million, the company expects to pay off the remainder of the royalty-backed debt by the end of the first quarter of 2020;

Year-end cash, cash equivalents and marketable securities balance of $210 million to $220 million.

Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for the fourth quarter of 2018 today, Thursday, February 21 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme’s corporate website and a replay will be available following the close of the call. To access the webcast and additional documents related to the call, please visit halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The call may also be accessed by dialing (877) 410-5657 (domestic callers) or (334) 323-7224 (international callers) using passcode 387156. A telephone replay will be available after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID number 68892505.

On February 21, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) reported that it will present at the following conference (Press release, MorphoSys, FEB 21, 2019, View Source [SID1234533550]):

8th Annual Leerink Partners Global Healthcare Conference
Date: February 28, 2019, 2:30 pm EST (8:30 pm CET, 7:30 pm GMT)
Venue: New York, NY, USA
Presenter: Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG
Dr. Julia Neugebauer, Director Corporate Communications & IR

PDF versions of the presentations will be provided at www.morphosys.com. The link to the webcasts will be filed under www.morphosys.com/conference-calls.

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On February 21, 2019 Enzychem Lifesciences, Corp. (KOSDAQ: 183490) reported that the company has achieved a huge milestone by completing enrollment of the required 24 patients in Stage 1 of the Phase 2 CRIOM (Chemoradiation Induced Oral Mucositis) study (Press release, Enzychem Lifesciences, FEB 21, 2019, View Source [SID1234533560]).

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Stage 1 of the Phase 2 CRIOM study evaluates the maximum tolerable dose of EC-18 which will be used in Stage 2 of the study. Patient enrollment for Stage 2 is expected to begin in 2Q 2019. Enzychem has received Fast Track Designation by the U.S. Food and Drug Administration for the Phase 2 study evaluating lead investigational candidate EC-18 in CRIOM.

Enzychem’s lead investigational candidate EC-18, is in development for a variety of indications including Chemotherapy Induced Neutropenia (CIN), Chemoradiation Induced Oral Mucositis (CRIOM), and Acute Radiation Syndrome (ARS). Enzychem Lifesciences was awarded U.S. FDA Fast Track Designation for EC-18 in CRIOM and FDA Orphan Drug Designation in ARS. CIN and CRIOM are in Phase II clinical trials and a pivotal study evaluating EC-18 in ARS is expected to begin under FDA’s animal rule guidance.