On August 12, 2019 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported financial results for the second quarter ended June 30, 2019, and provided a corporate update (Press release, Cellectar Biosciences, AUG 12, 2019, View Source [SID1234538589]).

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"We made considerable progress on both the clinical and regulatory fronts during the second quarter and subsequent period. CLR 131 continues to advance, delivering encouraging preliminary data with improving efficacy and a clear dose response in our ongoing Phase 1 study. In addition, the company received FDA Fast Track Designation for CLR 131 in two separate indications and believe that we continue to track toward a registrational study in at least one B-cell hematologic malignancy from our ongoing Phase 2 CLOVER-1 study," said Jim Caruso, CEO of Cellectar. "Our recently adopted fractionated dosing schedule of CLR 131 has led to the improved efficacy and tolerability observed in our latest cohorts and we are moving forward with this dosing strategy in our recently initiated pediatric Phase 1 trial for the treatment of life-threatening cancers."

Second Quarter and Recent Corporate Highlights

·Announced initial results from Cohort 6 in the company’s ongoing Phase 1 clinical study with CLR 131 in Relapsed or Refractory Multiple Myeloma (R/R MM). Data from Cohort 6 showed improved efficacy and a clear dose response compared to prior cohorts, including a 50% overall response rate, a 50% minimal response rate and 100% disease control rate. The International Myeloma Working Group defines a partial response as a 50% to 89.9% reduction in the marker of disease and minimal response as 25% to 49.9% reduction in the marker of disease. One patient achieved a minimal response with a 48% reduction in their m-protein. The other patient achieving a minimal response had a 39% reduction in m-protein remains on study and continues to be evaluated.

·Expanded the third cohort of our ongoing Phase 2 CLOVER-1 study of CLR 131 after preliminary results showed it exceeded pre-specified performance criteria. We are currently enrolling patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL) and marginal zone lymphoma (MZL) in the third cohort. The company continues to expect to report top-line data from the Phase 2 CLOVER-1 study in 2019.

·Received FDA Fast Track Designation for CLR 131 in two separate indications: in fourth line or later relapsed/refractory multiple myeloma and in relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL). CLR 131 is currently being evaluated in Cellectar’s ongoing CLOVER-1 Phase 2 clinical study in patients with select B-Cell lymphomas, including multiple myeloma and DLBCL.

·Closed on a financing for gross proceeds of $10 million. In a registered direct offering, Cellectar issued 1,982,000 shares of common stock. In a separate concurrent private placement transaction, Cellectar sold 2,018,000 shares of common stock. In conjunction with the offerings, the company also issued 4,000,000 warrants to purchase common stock in the private placement.

Second Quarter Summary of Financial Results

Cash and Cash Equivalents: As of June 30, 2019, cash and cash equivalents were approximately $16.8 million compared to $13.3 million as of December 31, 2018. We believe that our cash balance is adequate to fund our basic budgeted operations through the fourth quarter of 2020. Cash used in operating activities was approximately $5.5 million during the six months ended June 30, 2019 as compared to $5.7 million used during the six months ended June 30, 2018.

Research and Development Expense: R&D expense for the three months ended June 30, 2019 was $1.8 million compared to $1.7 million in the three months ended June 30, 2018. The cumulative R&D spending for the first six months of 2019 was $4.1 million as compared to $3.8 million for the first six months of 2018. The majority of the company’s R&D spend for year-to-date 2019 was dedicated to the start-up and support of our pediatric study with $1.3 million and $2.9 million spent for the three and six months ending June 30, 2019, respectively, related to clinical project costs and manufacturing expenses.

General and Administrative Expense: General and administrative (G&A) expense for the three months ended June 30, 2019 was approximately $1.4 million compared to approximately $1.2 million in the three months ended June 30, 2018. The cumulative G&A spending for the first six months of 2019 were of $2.7 million as compared to $2.6 million for the first six months of 2018.

Net Loss: Net loss for the three months ended June 30, 2019 was $(3.2) million, or a loss of $(0.46) per diluted share, compared to a net loss of $(2.9) million, or a loss of $(1.69) per diluted share, in the three months ended June 30, 2018. Net loss for the six months ended June 30, 2019 was $(6.8) million, or a loss of $(1.15) per diluted share, compared to a net loss of $(6.4) million, or a loss of $(3.75) per diluted share, in the six months ended June 30, 2018.

About CLR 131

CLR 131 is a small-molecule, targeted Phospholipid Drug Conjugate (PDC) designed to deliver cytotoxic radiation directly to cancer cells, while limiting exposure to healthy cells. CLR 131 is the company’s lead product candidate and is currently being evaluated in a Phase 2 study in B-Cell lymphomas, and two Phase 1 dose-escalating clinical studies, one in multiple myeloma and one in pediatric solid tumors and lymphoma. CLR 131 was granted Orphan Drug designation for the treatment of multiple myeloma, and was granted Orphan Drug and Rare Pediatric Disease designations for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma.

On August 9, 2019 SHINE Medical Technologies LLC reported it has received a $15-million award from the Department of Energy’s National Nuclear Security Administration (DOE/NNSA) (Press release, Shine Medical Technologies, AUG 9, 2019, View Source;pk_kwd=15-million-doe-nnsa-award-for-production-of-medical-isotope [SID1234540974]). The award was made by the agency as part of its effort to establish a reliable, U.S.-produced supply of molybdenum-99 (Mo-99), the most commonly used medical isotope, without the use of highly enriched uranium. The cooperative agreement with the DOE/NNSA requires SHINE to provide $15 million of matching funds.

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Medical isotopes are used in heart stress tests, cancer staging and therapeutics, and other medical applications. Chronic global shortages of Mo-99 routinely and significantly affect the diagnosis and treatment of patients in the United States and around the world.

SHINE broke ground in May on an isotope production facility in Janesville, Wisconsin. It will be the first facility of its kind in the world, using the company’s patented technology to produce Mo-99 and other isotopes used in more than 40 million procedures every year. When the facility becomes operational after the company receives approval to operate from the Nuclear Regulatory Commission (NRC), the plant will be capable of producing the majority of U.S. demand for Mo-99. The NRC’s review is expected to take up to 24 months from its acceptance of SHINE’s application.

"We are grateful for DOE/NNSA’s award as SHINE continues its progress toward production of Mo-99 and other important medical isotopes," said Greg Piefer, SHINE’s founder and CEO. "SHINE’s recently-submitted operating license application to the NRC brings us one step closer to that goal. The recent DOE/NNSA award directly supports SHINE’s continued advancement as we work to supply lifesaving medical tracers and therapeutics to an underserved, growing global market."

About Medical Isotopes
Medical isotopes are radioisotopes that are used in the diagnosis and treatment of disease. Molybdenum-99 (Mo-99) is a radioisotope that decays into the diagnostic imaging agent technetium 99m (Tc-99m). The workhorse of nuclear medicine, Tc-99m is used in more than 40 million medical imaging procedures each year, primarily in stress tests to diagnose heart disease and to stage cases of cancer. SHINE was founded to deploy a safe, cost-effective and environmentally friendly technology to produce a variety of medical isotopes, including Mo-99. Roughly one percent of all Mo-99 in the world decays every hour, meaning it must be produced continuously. Current production is limited to only a handful of government-owned nuclear research reactors, the majority of which are overseas.

On August 9, 2019 NEC Corporation (NEC; TSE: 6701) and CYTLIMIC Inc. reported that financing of 1.3 billion yen (around US$ 12 million at current rate) was completed through the achievement of the milestones, including the first IND filing of CYT001*, pursuant to the agreement with current shareholders; i.e., NEC Corporation, NEC Capital Solutions Limited, Fast Track Initiative, Inc., and SMBC Venture Capital Co., Ltd. In total, 2.3 billion yen (around US$ 21 million) has been raised since the establishment of CYTLIMIC in December 2016 (Press release, NEC, AUG 9, 2019, View Source [SID1234538959]).

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In recent years, Immune-Checkpoint Inhibitors (ICI), such as anti-PD-(L)1 drug, have been expanding their applications; However, a combination of ICI with other drugs are still needed for more than 70% of patients who don’t respond to ICI alone. Among those combination drugs, cancer vaccine is considered as a promising approach to turn "Cold tumors to Hot ones" and to make ICI work. CYT001 is designed to effectively turn "Cold tumors to Hot ones" with the AI-designed optimized shared-antigen peptides, and an optimized combination adjuvant of Poly ICLC (Hiltonol) and LAG-3Ig (Eftilagimod alpha or IMP321). The recent financing allows CYTLIMIC to conduct further clinical trials for the POC establishment of CYT001.

On August 9, 2019 Lion TCR Pte. Ltd., a clinical-stage Biotech company focused on development of innovative engineered T cell immunotherapy against viral-related cancer and chronic Hepatitis B infection, reported on 29 July 2019 that it has signed an agreement with Dalian Lvshun District Government at the 10th Singapore-Liaoning Economic and Trade Council Meeting (SLETC) to develop cell manufacturing and research facilities for cancer treatment (Press release, Lion TCR, AUG 9, 2019, View Source [SID1234538769]). The 5,000-sqm facility, built by Dalian Municipal Government, will support Lion TCR’s development and commercialisation of cell therapy products in China in addition to Lion TCR’s facility at the China-Singapore Guangzhou Knowledge City. Lion TCR shall utilize GMP (Good Manufacturing Practice) certified entities for the production of advanced cellular immunotherapy products for clinical trials and for future commercial products. The facility design and process will comply with both China CDE and internationally recognized GMP guidelines.

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The 10th SLETC was chaired by Mr. Masagos Zulkifli, Singapore’s Minister for the Environment and Water Resources, and Mr. Tang Yijun, Liaoning Governor, the Co-Chairmen of SLETC. At the council meeting, 11 Singapore companies including Lion TCR signed project agreements to provide greater connectivity, sustainability, technology and healthcare in Liaoning. Singapore is Liaoning’s third largest foreign investor with a total investment of about S$19 billion (95 billion yuan). Minister Masagos told the Party Secretary and Mayor of Dalian City at their meeting: "Singapore looks forward to deepening cooperation with Dalian in environmental protection, new energy, interconnection, biomedical, petrochemical, marine fishery, food processing, sustainable development and other fields."

Mr. Stephen Lim, CEO of Lion TCR commented that "Lion TCR looks forward to using this Dalian GMP cell therapy facilities as a manufacturing base for our China commercialisation needs. As a stand-alone building is required for cell therapy GMP application in China, this offer to build with option for Lion to purchase by the Dalian Government is a great help to Lion as it frees our immediate cashflow for continual research and on-going clinical trials."

Mr. Masagos Zulkifli, Singapore’s Minister for the Environment and Water Resources, Singapore Co-Chair of Singapore-Liaoning Economic and Trade Council (fourth from left); Mr. Stephen Lim, CEO of Lion TCR (third from left); Dr. Victor Li, Chairman of Lion TCR (third from right).

On August 9, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that Ivan Bergstein, M.D., Stemline’s CEO, will present at the 2019 Wedbush PacGrow Healthcare Conference on Tuesday, August 13, 2019 at 4:15 PM ET at the Parker New York Hotel (Press release, Stemline Therapeutics, AUG 9, 2019, View Source [SID1234538582]). A live webcast of the presentation can be viewed on the company’s website at www.stemline.com.

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About ELZONRIS
ELZONRIS (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.