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GlobeNewswire
Cellectar reports its third quarter 2020 financial results and provides a company update
FLORHAM PARK, NJ, November 9, 2020 (GLOBE NEWSWIRE) – Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late stage clinical biopharmaceutical company focused on the discovery, development and commercialization of cancer treatment drugs, announced today the financial results for the third quarter ended September 30, 2020 and provided a company update. Third quarter and recent company highlights * FDA Type B orientation meeting to define the registration path for our priority adult cancer hematology indications and planned start of the pivotal study for our main indication in the fourth quarter * CLR 131 announced achieved a 40% overall response rate (ORR) in patients with triple class refractory multiple myeloma (MM) with an administered total body dose (TBD) of 60 mCi or greater from the phase 2 CLOVER-1 study * Phase 2 COVER-1 study at the American Association Virtual Cancer Research Meeting (AACR): Advances in malignant lymphoma demonstrated 100% ORR and 75% greater response rate (MRR) in LPL / WM . Mean duration of response greater than 17 months (8.4 – 31.7 months); duration of response continues to increase for all patients * Strengthened management team with appointment of Dr. John Friend, Medical Director “We continue to make good progress towards the start of the fourth quarter of the pivotal CLR 131 study in our heme- primary oncology indication. Our recent FDA orientation meeting has been very encouraging and we look forward to providing more details in the near term, ”said James Caruso, president and CEO of Cellectar. “The additional data from our Phase 2 CLOVER-1 study remains strong, with patients in WM achieving a 100% ORR and a 75% MRR in patients failing a BTKi and 40% ORR in the Difficult-to-treat triple class refractory MM patient population. “Third Quarter 2020 Financial Aspects * Cash and Cash Equivalents: As of September 30, 2020, the company had cash and cash equivalents of $ 18.8 million compared to $ 10.6 million as of December 31, 2019. Cash used in operating activities was of approximately $ 10.1 million during the nine months ending September 30, 2020 compared to $ 9.0 million during the nine months ending September 30, 2019. * Research and development expenses: research and development expenses for the three months ending September 30, 2020, was $ 2.7 million, compared to $ 2.7 million for the three months ending September 30, 2019. Cumulative R&D spending for the first nine months of 2020 was $ 7.8 million compared to $ 6.8 million in the first nine months of 2019. The increase in research and development expenses since the beginning of the year in 20 20 was mainly the result of higher general research and development costs deriving from higher costs related to personnel and costs of clinical trials. Production and related costs have decreased due to a reduction in material production processes and related costs. * General and Administrative Expenses: General and administrative expenses for the three months ending September 30, 2020 were $ 1.2 million compared to $ 1.3 million for the three months ending September 30, 2019. Cumulative spending for the first nine months of 2020 was $ 3.7 million as compared to $ 4.0 million for the first nine months of 2019. The decrease in G&A spending since the beginning of the year in 2020 was mainly the result of lower share-based compensation expenses. * Net Loss: The net loss attributable to common shareholders for the three months ending September 30, 2020 was ($ 3.9) million, or ($ 0.15) per share, compared with ($ 3.9) ) million, or ($ 0.42) per share, in 2019. The net loss attributable to common shareholders for the nine months ending September 30, 2020 was ($ 11.5) million, or ($ 0, 69) per share, compared to ($ 10.7) million, or ($ 1.51) per share, in 2019. About Cellectar Biosciences, Inc Cellectar Biosciences focuses on drug discovery, development and commercialization for the cancer treatment. The company is developing proprietary drugs independently and through research and development collaborations. The company’s primary goal is to leverage its proprietary Phospholipid Drug Conjugate ™ (PDC) delivery platform to develop PDCs that specifically target cancer cells, offering better efficacy and increased safety as a result of fewer off-target effects. . The company’s PDC platform possesses the potential for discovering and developing the next generation of cancer treatments and plans to develop PDC independently and through R&D collaborations. The company’s primary therapeutic PDC, CLR 131, it is currently divided into two clinical trials. The Phase 2 CLOVER-1 study and the Phase 1 pediatric safety study. The CLOVER-1 study met the primary efficacy endpoints of the Dose Exploration Part of Part A, conducted in B-cell malignancies r / r, and is now enrolling in expansion cohorts evaluating the BTK inhibitor in triple-class refractory multiple myeloma and in patients with Waldenstrom’s unsuccessful macroglobulinemia. The dosing regimen is designed to provide the optimal dose identified in Part A of> 60 mCi of total body dose. Part A data was announced on February 19, 2020 The Phase 1 Pediatric Study is an open-label, sequential group dose escalation study to assess the safety and tolerability of CLR 131 in children and adolescents with relapse or refractory tumors, including malignant brain tumors, neuroblastoma, sarcomas and lymphomas (including Hodgkin’s lymphoma). The Phase 1 study is conducted internationally at seven major pediatric cancer centers. The company’s product pipeline includes a preclinical PDC chemotherapy program (CLR 1900) and multiple associated PDC resources. For more information, visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: Twitter, LinkedIn and Facebook Forward-looking statement Disclaimer This press release contains forward-looking statements. These statements can be identified by using words such as “could”, “expect”, “believe”, “anticipate”, “intend”, “could”, “estimate”, “continue”, “plans” or their negative or similar. These statements are estimates and forecasts only and are subject to known and unknown risks and uncertainties that could cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations regarding such future outcomes, including our expectations about the impact of the COVID-19 pandemic. Drug discovery and development carry a high degree of risk. Factors that could cause such a material difference include, among others, the uncertainties related to the ability to raise additional capital, the uncertainties related to outages at our single source CLR 131 provider, the ability to attract and retain partners for our technologies, the identification of lead compounds, their successful preclinical development, patient enrollment and completion of clinical trials, the FDA review process and other government regulations, our ability to maintain drug designation orphaned in the United States due to CLR 131, the volatile market for priority review vouchers, the ability of our pharmaceutical collaborators to successfully develop and market candidate drugs, competition from other pharmaceutical companies, product pricing and third-party reimbursements. A full description of the risks and uncertainties relating to our business is contained in our periodic reports filed with the Securities and Exchange Commission, including our Form 10-K for the year ended December 31, 2019, our Form 10-Q for the quarter ended March 31, 2020, our Form 10-Q for the quarter ended June 30, 2020, and our Form 10-Q for the quarter ended September 30, 2020, if filed. These forward-looking statements are made only as of the date of this document and we disclaim any obligation to update such forward-looking statements. These forward-looking statements are made only as of the date of this document and we disclaim any obligation to update such forward-looking statements. Investor Contacts: Monique Kosse Managing Director LifeSci Advisors, LLC 646-915-3820 [email protected] CELLECTAR BIOSCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEET 30 September 2020 (unaudited) 31 December 2019 ASSETS CURRENT ASSETS: Cash and cash equivalents $ 18,841,944 $ 10,614,722 Deferred expenses and other current assets 960,906 770,951 Total current assets 19,802,850 11,385,673 Fixed assets , net 374,697 of 435,073 use assets, net 299,982 348,841 Long-term assets 219,121 75,000 Other assets – 6,214 TOTAL ASSETS $ 20,696,650 $ 12,250,811 LIABILITIES AND SHAREHOLDERS ‘EQUITY CURRENT LIABILITIES: Payables and accrued liabilities $ 3,839,318 $ 2,663,873 CURRENT LIABILITIES SHARE: Lease liabilities 333,375 421,644 Loan loan 184,000 – Total long-term liabilities 517,375 421,644 TOTAL LIABILITIES 4,472,950 3,191,402 COMMITMENTS AND POTENTIAL (Note 7) EQUITY: Preferred shares, nominal value $ 0.00001; 7,000 authorized shares; Series C Preferred Shares: 215 issued and outstanding as of September 30, 2020 and December 31, 2019 1,148,204 1,148,204 Common Shares, par value of $ 0.00001; 80,000,000 authorized shares; 26,813,593 and 9,386,689 shares issued and outstanding at 30 September 2020 and 31 December 2019 respectively 268 94 Additional paid-up capital 138,235,579 119,592,366 Accumulated deficit (123,160,351) (111,681,255) Total shareholders’ equity 16,223. 700 9,059,409 TOTAL LIABILITIES AND SHAREHOLDERS $ 20,696 $ 12,250,811 CELLECTAR BIOSCIENCES, INC. CONDENSED CONSOLIDATED MANAGEMENT REPORTS (NOT CONTROLLED) Three months to September 30, nine months to September 30 2020 2019 2020 2019 COSTS AND EXPENSES: Research and development $ 2,683,944 $ 2,703,831 $ 7,765,673 $ 6,821,775 Overheads and administrative expenses 1,258,975 3,753,175 $ and expenses 3,909,937 3,963,879 11,490,826 10,794,050 OPERATING LOSS (3,909,937) (3,963,879) (11,490,826) (10,794,050) OTHER INCOME: Revaluation profit derivative warrants – 46,000 – 43,000 Net income interest 374 14,072 11,730 38,041 Total other income 374 60,072 11,730 81,041 NET LOSS $ (3,909,563) $ (3,903,807) $ (11,479,096) $ (10,713,009) NET LOSS BASE AND DILUTITY ATTRIBUTABLE TO COMMON SHAREHOLDERS PER COMMON SHARE $ ($ 0.15) 0.42) $ (0.69) $ (1.51) SHARES USED FOR CALCULATION OF THE BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON SHAREHOLDERS PER SHARE MUNICIPALITY 26,326,782 9,386,703 16,539,183 7,098,285
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