On May 15, 2019 VBL Therapeutics (Nasdaq: VBLT) reported financial results for the first quarter ended March 31, 2019, and provided a corporate update (Press release, VBL Therapeutics, MAY 15, 2019, View Source [SID1234536306]).

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"As we continue to advance development of VB-111, we are getting a better understanding of its mechanism of action and how best to incorporate it into oncology treatment regimens," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "We expect two additional VB-111 clinical trials to begin this year, a Phase 2 trial in colon cancer in combination with a checkpoint inhibitor (in collaboration with the National Cancer Institute) and an investigator-sponsored study in recurrent glioblastoma which will be conducted by a group of top US neuro-oncology centers. Therefore, together with the ongoing Phase 3 OVAL pivotal study in ovarian cancer, there will be a total of three VB-111 clinical trials up and running in the second half of 2019.

We are also pleased to announce that there will be two presentations on VB-111 at the upcoming 2019 ASCO (Free ASCO Whitepaper) Annual Meeting in early June, by Dr. Richard Penson from Massachusetts General Hospital on the final Phase 2 results in ovarian cancer, and by Dr. Benjamin Ellingson from UCLA on VB-111 Phase 2 and Phase 3 MRI data in recurrent GBM.

In addition to advancing VB-111, we are also moving forward with two parallel development programs targeting MOSPD2, which has significant potential as a therapeutic target for both inflammatory diseases and cancer."

"We had $47.7 million in cash and cash equivalents at March 31, 2019, which we believe is sufficient to continue development of VB-111 and other product candidates and to fund our operating expenses and capital expenditure requirements through 2021," said Amos Ron, Chief Financial Officer of VBL Therapeutics.

First Quarter and Recent Corporate Highlights:

Executed a strategic exclusive option license agreement with one of the world-leading European animal health companies, for the development of VBL’s proprietary anti-inflammatory molecule, VB-201, for veterinary use. VBL received an undisclosed up-front payment and upon exercising the option to license, VBL expects to receive additional milestones and royalties, which may exceed €50 million. VBL retains worldwide rights for the use of VB-201 for the treatment of humans.

Awarded a non-dilutive grant of over 10 million New Israeli Shekels (approximately $2.9 million) by the Israel Innovation Authority (IIA), to support continued development of VB-111 for 2019.

Presented new data indicating that VB-111 has potential to stimulate the immune system to induce a strong and durable response against ovarian tumors at the Society for Gynecologic Oncology 50th Annual Meeting on Women’s Cancer. The Company’s ongoing potential registration OVAL pivotal trial in platinum resistant ovarian cancer continues to enroll patients as planned.

MOSPD2 program for inflammation: Presented new data at the Keystone Symposia on the role of MOSPD2 in the migration of certain inflammatory cells, the myeloid cells. VBL is developing the VB-600 platform of antibodies targeting MOSPD2 for treatment of various inflammatory indications.

MOSPD2 oncology program: VBL is currently developing bi-specific antibodies that bring together tumor cells, via MOSPD2, and T cells, via CD3, to recruit the immune system to fight tumor cells.

First Quarter ended March 31, 2019 Financial Results:

Cash Position: At March 31, 2019, the Company had cash, cash equivalents and short-term bank deposits totaling $47.7 million and working capital of $43.1 million. The Company expects that its cash, cash equivalents and short-term bank deposits will enable it to fund operating expenses and capital expenditure requirements through 2021.

Revenues: Revenues related to VBL’s collaborations were $0.2 million in the first quarter of 2019.

R&D Expenses: Research and development expenses, net, after government grants, for the quarter ended March 31, 2019, were approximately $3.3 million, compared to approximately $5.8 million in the same period in 2018.

G&A Expenses: General and administrative expenses for the quarter ended March 31, 2019 were $1.3 million, compared to $1.4 million for the same period in 2018.

Comprehensive Loss: VBL reported a net loss for first quarter ended March 31, 2019, of $4.2 million, or ($0.12) per share, compared to a net loss of $7.2 million, or ($0.24) per share, in the quarter ended March 31, 2018.

For further details on VBL’s financials, please refer to Form 6-K filed with the SEC.

Conference Call:

Wednesday, May 15th @ 8:30am Eastern Time

From the US: 877-407-9208

International: 201-493-6784

Conference ID: 13690495

Webcast: View Source

On May 15, 2019 Veru Inc. (NASDAQ: VERU) an oncology and urology biopharmaceutical company developing novel medicines for prostate cancer treatment and prostate cancer supportive care, reported its financial results for its fiscal 2019 second quarter ended March 31, 2019 (Press release, Veru, MAY 15, 2019, View Source [SID1234536336]).

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Business and Operational Highlights

VERU-111: Our oral, next-generation, first-in-class, alpha and beta antitubulin is being evaluated in men who have metastatic prostate cancer and whose disease is resistant to both castration and novel androgen blocking agents (abiraterone or enzalutamide). The open label Phase 1b clinical trial being conducted to determine the maximally tolerated dose is progressing. The open label Phase 2 clinical study is expected to commence in the Fall of 2019. Oral drugs for advanced prostate cancer, abiraterone and enzalutamide, had over $3 billion in U.S. annual sales in 2018 and $6 billion in 2018 global revenue. Men with metastatic castration resistant prostate cancer who have failed these novel androgen blocking agents is the population that VERU-111 is targeting which represents an estimated $4.5 billion annual global market.

Zuclomiphene Citrate: Enrollment of approximately 100 men in the Phase 2 clinical trial is progressing in approximately 17 clinical sites in the US. Top line results of the study are expected Summer 2019. Zuclomiphene Citrate is a novel, proprietary, oral, nonsteroidal, estrogen receptor agonist to treat hot flashes caused by androgen deprivation therapy, or hormone treatment for men with advanced prostate cancer. Based on an independent market analysis sponsored by the Company, the expected U.S. sales potential for zuclomiphene citrate is estimated to exceed $600 million annually.

TADFIN (Tadalafil and Finasteride Combination Tablet): As previously announced, the Company completed a successful bioavailability and bioequivalence clinical trial for TADFIN for benign prostatic hyperplasia. The Company filed patent applications that, if issued, would have an expiry of 2040. NDA submission expected late 2019 to early 2020 with anticipated approval in 2020. BPH is an established multi-billion-dollar market.

"The clinical development of our proprietary drug pipeline is advancing," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. "In clinical observations, VERU-111 appears to be well tolerated, with no documented complaints or evidence of neurotoxicity or neutropenia. Moreover, in a number of men whose PSA was rising prior to enrollment into the Phase 1b clinical trial, we are seeing some evidence of PSA stabilizations and reductions even at the lowest doses of VERU-111 being tested, which is a promising early indication of efficacy. As for our zuclomiphene citrate product, based on the blinded aggregate preliminary clinical data from our placebo-controlled trial, we can make the following general clinical observations: men are experiencing reductions in hot flashes; and as for safety, zuclomiphene citrate appears to be well tolerated."

Fiscal 2019 Second Quarter vs Fiscal 2018 Second Quarter Financial Results

Net revenues up 171% to $7.0 million from $2.6 million. Company reported FC2 sales growth in both its public sector and its US prescription channels;

Gross profit up 285% to $4.6 million, or 66% of net revenues, from $1.2 million, or 47% of net revenues;

FC2 US prescription channel net revenues up 753% to $2.6 million from $0.3 million;

FC2 public sector channel net revenues up 88% to $4.2 million from $2.3 million;

Financial results do not reflect the new tender orders that will be coming from South Africa. We expect new orders from South Africa to commence shipping during the third quarter of this fiscal year;

Commercial segment, which includes FC2, PREBOOST and drug commercialization costs, generated operating income of $3.2 million versus an operating loss of $163,000;

Operating loss significantly narrowed to $2.1 million from $4.7 million; and

Net loss was $4.0 million, or $0.06 per share, compared with $3.8 million, or $0.07 per share.

Fiscal 2019 Year-to-Date vs Fiscal 2018 Year-to-Date Financial Results

Net revenues up 159% to $13.3 million from $5.2 million;

Gross profit up 268% to $9.3 million, or 69% of net revenues, from $2.5 million, or 49% of net revenues;

Net revenue from the US prescription channel was up 1,000% to $5.0 million from $458,000 in the prior-year period;

Net revenue for the public sector channel was up 73% to $8.1 million from $4.7 million in the prior-year period;

Net revenue for PREBOOST/ Roman Swipes was $180,000 compared to $4,600 in the prior-year period; an increase of 3800%;

Operating loss down 74% to $3.1 million from $12.1 million (fiscal 2018 year to date included a $3.8 million loss for the settlement of Brazilian receivables); and

Net loss was $6.2 million, or $0.10 per share, compared with $8.1 million, or $0.15 per share.

"We have achieved strong operating results through the first two quarters of fiscal 2019," said Dr. Steiner. "Positive financial growth continued into our second quarter, with sequential quarterly increases to net revenues from both our FC2 US prescription and public sector channels. Growth of our US FC2 prescription channel is particularly noteworthy as it appears to be less reliant on traditional intermittent ordering patterns present in our FC2 public sector channel."

Financial Guidance

Management expects net revenues will grow to $29-32 million for the full year FY2019 which represents a 95% increase over the full year FY2018, and management expects gross margin will be approximately 66% in FY2019 compared to 55% in FY2018.

"Based on current cash on hand and expected cash from current sales forecasts, along with existing sources of capital, the Company does not anticipate the need for a new equity financing until at least fiscal 2021," said Dr. Steiner.

The Company does not expect to update the guidance for the full year fiscal 2019 provided above before the release announcing results for the next fiscal quarter. The Company notes that the statements of future performance made in this release, including the guidance for the full fiscal year 2019, are based upon current expectations and are subject to factors that could cause actual results to differ materially from those suggested here, including those factors set forth in the "Safe Harbor" Statement below.

Conference Call Event Details

Veru Inc. will host a conference call today at 8 a.m. ET to review the Company’s performance. Interested investors may access the call by dialing 800-341-1602 from the U.S. or 412-902-6706 from outside the U.S. and asking to be joined into the Veru Inc. call.

In addition, investors may access a replay of the conference call the same day beginning at approximately noon Eastern Time by dialing 877-344-7529 for US callers, or 412-317-0088 from outside the U.S., passcode 10130716. The replay will be available for one week, after which, the recording will be available via the Company’s website at View Source

On May 15, 2019 Kite, a Gilead Company (Nasdaq: GILD), reported that new data from its cell therapy programs will be presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) being held in Chicago from May 31 – June 4, 2019 (Press release, Kite Pharma, MAY 15, 2019, View Source [SID1234536353]). Six abstracts highlighting updated Yescarta (axicabtagene ciloleucel) efficacy and safety results, and ongoing research from the company’s chimeric antigen receptor T (CAR T) cell therapy development program in hematologic malignancies will be presented at the meeting.

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"Our CAR T research program is progressing at a rapid pace and we are excited to share the latest data at ASCO (Free ASCO Whitepaper)," said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. "Our data at this year’s meeting will include new analyses from the pivotal ZUMA-1 trial of Yescarta, early results from a novel approach to improve the Yescarta safety profile and results from the ZUMA-3 trial of our investigational CAR T therapy KTE-X19 in adults with acute lymphoblastic leukemia. These findings will help physicians better assess the potential role of CAR T in patients with high unmet need and continue to build upon our understanding of cell therapy."

Kite, a Gilead Company (Nasdaq: GILD), reported that new data from its cell therapy programs will be presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) being held in Chicago from May 31 – June 4, 2019. Six abstracts highlighting updated Yescarta (axicabtagene ciloleucel) efficacy and safety results, and ongoing research from the company’s chimeric antigen receptor T (CAR T) cell therapy development program in hematologic malignancies will be presented at the meeting.

"Our CAR T research program is progressing at a rapid pace and we are excited to share the latest data at ASCO (Free ASCO Whitepaper)," said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. "Our data at this year’s meeting will include new analyses from the pivotal ZUMA-1 trial of Yescarta, early results from a novel approach to improve the Yescarta safety profile and results from the ZUMA-3 trial of our investigational CAR T therapy KTE-X19 in adults with acute lymphoblastic leukemia. These findings will help physicians better assess the potential role of CAR T in patients with high unmet need and continue to build upon our understanding of cell therapy."

Area of Focus, Presentation
Number and Date/Time
(CDT)

Abstract Title
Presentations
Acute Lymphoblastic Leukemia
Abstract #7006 (Oral)
Saturday, June 1 (5:00-5:12 pm)

End of Phase 1 Results of ZUMA-3, a Phase 1/2 Study of KTE-X19, Anti-CD19 Chimeric Antigen Receptor T Cell Therapy, in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia
Large B-Cell Lymphoma
Abstract #7555 (Poster)
Monday, June 3 (8:00-11:00 am)

Outcomes of Patients ≥ 65 Years of Age in ZUMA-1, a Pivotal Phase 1/2 Study of Axicabtagene Ciloleucel in Refractory Large B-Cell Lymphoma
Large B-Cell Lymphoma
Abstract #7558 (Poster)
Monday, June 3 (8:00-11:00 am)

Preliminary Results of Earlier Steroid Use with Axicabtagene Ciloleucel in Patients with Relapsed/Refractory Large B-Cell Lymphoma
Large B-Cell Lymphoma
Abstract #7545 (Poster)
Monday, June 3 (8:00-11:00 am)

Hematopoietic Recovery and Immune Reconstitution After Axicabtagene Ciloleucel Chimeric Antigen Receptor T Cell Therapy in Patients with Relapsed/Refractory Large B-cell Lymphoma
Trials-In-Progress

Chronic Lymphocytic Leukemia
Abstract #TPS7566 (Poster)
Monday, June 3 (8:00-11:00 am)

ZUMA-8: A Phase 1/2 Multicenter Study Evaluating KTE-X19 in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia
Large B-Cell Lymphoma
Abstract #TPS7574 (Poster)
Monday, June 3 (8:00-11:00 am)

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

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

Yescarta was the first CAR T cell therapy to be approved by the U.S. Food and Drug Administration (FDA) 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, primary mediastinal large B-cell lymphoma, and high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. The Yescarta U.S. Prescribing Information has a BOXED WARNING for the risks of cytokine release syndrome and neurologic toxicities; see below for Important Safety Information.

KTE-X19 is an investigational agent that has not been approved by the U.S. Food and Drug Administration or any regulatory authority for any uses. Efficacy and safety have not yet been established.

U.S. Important Safety Information for Yescarta

BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving Yescarta. Do not administer Yescarta to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving Yescarta, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with Yescarta. Provide supportive care and/or corticosteroids as needed.
Yescarta is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta REMS.
CYTOKINE RELEASE SYNDROME (CRS): CRS occurred in 94% of patients, including 13% with ≥ Grade 3. Among patients who died after receiving Yescarta, 4 had ongoing CRS at death. The median time to onset was 2 days (range: 1-12 days) and median duration was 7 days (range: 2-58 days). Key manifestations include fever (78%), hypotension (41%), tachycardia (28%), hypoxia (22%), and chills (20%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome. Ensure that 2 doses of tocilizumab are available prior to infusion of Yescarta. Monitor patients at least daily for 7 days at the certified healthcare facility following infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for 4 weeks after infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab or tocilizumab and corticosteroids as indicated.

NEUROLOGIC TOXICITIES: Neurologic toxicities occurred in 87% of patients. Ninety-eight percent of all neurologic toxicities occurred within the first 8 weeks, with a median time to onset of 4 days (range: 1-43 days) and a median duration of 17 days. Grade 3 or higher occurred in 31% of patients. The most common neurologic toxicities included encephalopathy (57%), headache (44%), tremor (31%), dizziness (21%), aphasia (18%), delirium (17%), insomnia (9%) and anxiety (9%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events including leukoencephalopathy and seizures occurred with Yescarta. Fatal and serious cases of cerebral edema have occurred in patients treated with Yescarta. Monitor patients at least daily for 7 days at the certified healthcare facility following infusion for signs and symptoms of neurologic toxicities. Monitor patients for signs or symptoms of neurologic toxicities for 4 weeks after infusion and treat promptly.

YESCARTA REMS: Because of the risk of CRS and neurologic toxicities, Yescarta is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta REMS. The required components of the Yescarta REMS are: Healthcare facilities that dispense and administer Yescarta must be enrolled and comply with the REMS requirements. Certified healthcare facilities must have on-site, immediate access to tocilizumab, and ensure that a minimum of 2 doses of tocilizumab are available for each patient for infusion within 2 hours after Yescarta infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense or administer Yescarta are trained about the management of CRS and neurologic toxicities. Further information is available at www.YESCARTAREMS.com or 1-844-454-KITE (5483).

HYPERSENSITIVITY REACTIONS: Allergic reactions may occur. Serious hypersensitivity reactions including anaphylaxis may be due to dimethyl sulfoxide (DMSO) or residual gentamicin in Yescarta.

SERIOUS INFECTIONS: Severe or life-threatening infections occurred. Infections (all grades) occurred in 38% of patients, and in 23% with ≥ Grade 3. Grade 3 or higher infections with an unspecified pathogen occurred in 16% of patients, bacterial infections in 9%, and viral infections in 4%. Yescarta should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after Yescarta infusion and treat appropriately. Administer prophylactic anti-microbials according to local guidelines. Febrile neutropenia was observed in 36% of patients and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids and other supportive care as medically indicated. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with drugs directed against B cells. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

PROLONGED CYTOPENIAS: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and Yescarta infusion. Grade 3 or higher cytopenias not resolved by Day 30 following Yescarta infusion occurred in 28% of patients and included thrombocytopenia (18%), neutropenia (15%), and anemia (3%). Monitor blood counts after Yescarta infusion.

HYPOGAMMAGLOBULINEMIA: B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia occurred in 15% of patients. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following Yescarta treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Yescarta treatment, and until immune recovery following treatment.

SECONDARY MALIGNANCIES: Patients may develop secondary malignancies. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following Yescarta infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

ADVERSE REACTIONS: The most common adverse reactions (incidence ≥ 20%) include CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections-pathogen unpecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias.

On May 15, 2019 Nektar Therapeutics (Nasdaq: NKTR) reported five abstracts accepted for presentation at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), which is being held from May 31 to June 4, 2019 at the McCormick Place Convention Center in Chicago, Illinois (Press release, Nektar Therapeutics, MAY 15, 2019, View Source [SID1234536369]). The abstracts published in advance of the ASCO (Free ASCO Whitepaper) Annual Meeting were made available at 5:00 p.m. Eastern Daylight Time today on the ASCO (Free ASCO Whitepaper) meeting website at View Source

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"We are pleased to announce the presentation of five abstracts for our lead I-O investigational candidate, bempegaldesleukin, which includes important translational clinical data for the combination of bempeg with nivolumab as well as early data from an investigator-sponsored pilot study conducted in patients with heavily pre-treated, rapidly progressing and refractory sarcomas," said Stephen Doberstein, Ph.D., Chief Research & Development Officer at Nektar. "We are also highlighting several registrational trials underway for bempeg plus nivo in patients with melanoma and RCC. We believe bempeg has a unique and non-overlapping mechanism which synergizes with various immunotherapies, including checkpoint inhibitors, to improve the body’s cancer-fighting immune response and potentially improve treatment outcomes for patients with a variety of cancers."

Details of abstract presentations are as follows:

Developmental Immunotherapy and Tumor Immunobiology
Abstract #2584/Poster Board #228*
Title: "Overcoming genetically-based resistance mechanisms to PD-1 blockade", Torrejon, D., et al.
Date: Saturday, June 1, 2019, 8:00 a.m. – 11:00 a.m. Central Time
Location: McCormick Place, Exhibit Hall A
*2019 ASCO (Free ASCO Whitepaper) Annual Meeting Merit Award recipient

Abstract #2623/Poster Board #267
Title: "Baseline tumor-immune signatures associated with response to bempegaldesleukin (NKTR-214) and nivolumab", Hurwitz, M., et al.
Date: Saturday, June 1, 2019, 8:00 a.m. – 11:00 a.m. Central Time
Location: McCormick Place, Exhibit Hall A

Emerging Combinations in Sarcoma Immunotherapy
Abstract #11010
Title: "Pilot study of bempegaldesleukin (NKTR-214) and nivolumab in patients with sarcomas"
Presenter: Sandra D’Angelo, M.D., Memorial Sloan Kettering Cancer Center
Date: Monday, June 3, 2019, 11:30 a.m. – 1:00 p.m. Central Time
Location: McCormick Place, S100a

Details of Trials in Progress poster presentations are as follows:

Melanoma/Skin Cancers
Abstract TPS9601/Poster Board #168b (Trials in progress (TiP) abstract)
Title: "CA045-001: A phase III, randomized, open label study of bempegaldesleukin (NKTR-214) plus nivolumab (NIVO) versus NIVO monotherapy in patients (pts) with previously untreated, unresectable or metastatic melanoma (MEL)", Khushalani, N., et al.
Date: Monday, June 3, 2019, 1:15 p.m. – 4:15 p.m. Central Time
Location: McCormick Place, Exhibit Hall A

Genitourinary (Nonprostate) Cancer
Abstract TPS4595/Poster Board #416b (Trials in progress (TiP) abstract)
Title: "A phase III randomized open label study comparing bempegaldesleukin (NKTR-214) plus nivolumab to sunitinib or cabozantinib (investigator’s choice) in patients with previously untreated advanced renal cell carcinoma", Tannir, N., et al.
Date: Monday, June 3, 2019, 1:15 p.m. – 4:15 p.m. Central Time
Location: McCormick Place, Exhibit Hall A

About Bempegaldesleukin (NKTR-214)
Bempegaldesleukin is an investigational, first-in-class, CD122-preferential IL-2 pathway agonist designed to provide rapid activation and proliferation of cancer-killing immune cells, known as CD8+ effector T cells and natural killer (NK) cells, without over activating the immune system. Bempegaldesleukin stimulates these cancer-killing immune cells in the body by targeting CD122 specific receptors found on the surface of these immune cells. CD122, which is also known as the Interleukin-2 receptor beta subunit, is a key signaling receptor that is known to increase proliferation of these effector T cells.1 In clinical and preclinical studies, treatment with bempegaldesleukin resulted in expansion of these cells and mobilization into the tumor micro-environment.2,3 Bempegaldesleukin has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines.

On May 15, 2019 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. pharmaceutical company with a platform to develop and accelerate the launch of innovative therapeutics and pharmaceutical products in China, the U.S., and throughout the world, reported financial results for the first quarter 2019 and provided a review of recent accomplishments and anticipated upcoming milestones (Press release, CASI Pharmaceuticals, MAY 15, 2019, View Source [SID1234536320]).

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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "We have made good progress in the first quarter of 2019. Most recently, we announced that we acquired exclusive worldwide rights to a novel anti-CD38 monoclonal antibody (CID-103). Preclinical data suggests an enhanced safety and efficacy profile against a broad array of hematological malignancies expressing CD38, making CID-103 an excellent strategic fit amid our broader oncology platform. We look forward to announcing progress in this program as well as across other key programs in our pipeline."

First Quarter and Recent Business Highlights

Acquired worldwide rights to CID-103, a novel anti-CD38 monoclonal antibody – On April 17, 2019, CASI acquired worldwide rights to CID-103, a novel anti-CD38 monoclonal antibody. CID-103 is a human monoclonal antibody targeting a specific epitope of the CD38 cell surface antigen. It is at the IND/IMPD submission stage of development with Phase 1 trials expected in late 2019 or early 2020. The addition of CID-103 compliments the Company’s oncology pipeline and allows the Company to provide more treatment options to patients in the future.

Entered into distribution agreement with China distribution partner for EVOMELA (melphalan hydrochloride for injection) – In March 2019, the Company entered into an exclusive distribution agreement with China Resources Guokang Pharmaceuticals Co., Ltd., (CRGK) to be the Company’s exclusive distributor in China for EVOMELA. CASI will maintain responsibility for direct marketing and sales.

Received National Medical Products Administration (NMPA) Clinical Trial Application (CTA) Approvals – In February and March 2019, CASI announced key NMPA clinical trial approvals (CTA) to conduct confirmatory registration trials for both ZEVALIN and MARQIBO, respectively. ZEVALIN is indicated for relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma and MARQIBO is indicated for Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. The Company is working toward getting the trials started in China.

Chairman Wei-Wu He, Ph.D. expanded role to include Chief Executive Officer – On April 2, 2019, CASI appointed its Chairman of the Board of Directors as the Company’s Chief Executive Officer. Dr. He served on CASI’s Board of Directors since 2012. Dr. He has a very successful career building companies from early stage to revenue and profitability stages and most recently was the CEO of OriGene Technologies which he co-founded and built into a profitable life science company; OriGene ultimately merged with a publicly traded Chinese company in 2018.

Financial Results for the Quarter ended March 31, 2019

Cash Position: As of March 31, 2019, CASI had cash and cash equivalents of $99.7 million.

R&D Expenses: R&D expenses for the quarter ended March 31, 2019 were $2.6 million compared to $1.7 million in 2018, an increase of $0.9 million. The increase in R&D expenses primarily reflects costs associated with regulatory, consulting and manufacturing related services, primarily associated with our acquired ANDAs in 2018, as well as an increase in facility costs due to new lease space in China, as well as an increase in personnel costs due to growth in the number of employees.

G&A Expenses: G&A expenses for the quarter ended March 31, 2019 were $5.7 million compared to $1.3 million in 2018. The increase of $4.4 million in G&A over the prior year primarily reflects an increase of $1.6 million in non-cash stock compensation expense largely attributed to stock options issued to the Company’s Chairman and also the President of CASI China, an increase in salary, benefits and recruitment expense, as well as facilities costs primarily in China, related to sales and marketing efforts to prepare for the anticipated launch of the Company’s first commercial product in China, as well as other G&A functions. There were also increased costs associated with professional services fees, including audit and legal services during the 2019 period.

Net Loss: The Company reported a net loss of ($8.2 million), or ($0.09) per share, for the quarter ended March 31, 2019. This compares with a net loss of ($3.6 million), or ($0.05) per share for the first quarter of 2018. The larger net loss for both periods is primarily due to the increase in non-cash stock-based compensation expense during the 2019 period, costs associated with the manufacturing and regulatory support for our ANDA portfolio, and increased costs associated with G&A functions, including employment costs for sales and marketing efforts, as well as increased facilities cost in China and higher professional service fees.

Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2019, can be found at www.casipharmaceuticals.com.