On March 21, 2018 Cellectar Biosciences, Inc. (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted treatments for cancer, reported financial results for 2017 and provided a corporate update (Press release, Cellectar Biosciences, MAR 21, 2018, View Source [SID1234524927]).
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Fourth Quarter 2017 and Recent Corporate Highlights
·Granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for CLR 131 to treat neuroblastoma, a rare pediatric cancer.
·Results from two preclinical studies highlighting the potential benefits of fractionated dosing regimens of CLR 131 and the ability of the company’s phospholipid ether-drug conjugates (PDCs) to provide improved targeting of tumor cells were selected for late-breaking poster presentations at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2018.
·Results from a Phase 1 study with CLR 124 further corroborating previous research showing the ability of the company’s PDC platform to cross the blood brain barrier and achieve uptake in brain tumors were accepted for oral presentation at the upcoming 12th World Congress of the World Federation of Nuclear Medicine and Biology in April 2018.
·Received a U.S. patent allowance that covers a method of use for CLR 131, the company’s lead radiotherapeutic PDC, for the treatment of multiple myeloma (MM) and also received a composition of matter patent in Japan.
·Initiated and enrolled the first patient in the diffuse large B-cell lymphoma cohort of the company’s Phase 2 clinical trial of CLR 131. This cohort is the fourth and final in the study for patients with relapsed or refractory (R/R) B-cell hematologic cancers.
·Filed an Investigational New Drug application with the FDA for a proposed Phase 1 study of CLR 131 in children and adolescents with select relapsed/refractory rare cancers, including malignant brain tumors.
·Increased the targeted patient enrollment to as many as 40 patients in the R/R MM cohort of the company’s currently enrolling Phase 2 clinical trial of CLR 131, as the data from the MM cohort demonstrated that the treatment exceeded pre-specified criteria.
"We made significant progress throughout 2017 advancing our pipeline and PDC therapeutic platform both through our own clinical development programs and through strategic collaborations. Our Phase 2 study for R/R MM and other B-Cell malignancies continues to move forward and we continue to be pleased with the results of our ongoing Phase 1 clinical trial of CLR 131 as a treatment for advanced MM," said James Caruso, president and CEO of Cellectar Biosciences. "We expect to achieve a number of important milestones in the coming months that should position us well for continued progress throughout the balance of 2018 and beyond."
2017 Financial Results
Research and development expenses for 2017 were approximately $9.5 million, compared with approximately $4.8 million for 2016. The increase is primarily attributable to increased support for the ongoing Phase 2 clinical trial in hematologic malignancies, as well as expanded preclinical development costs. In addition, 2017 research and development expenses include one-time non-cash depreciation expenses of approximately $1.2 million associated with shutting down the company’s small-scale manufacturing operation.
General and administrative expenses were approximately $4.1 million for 2017, compared with approximately $4.7 million for 2016.
The net loss attributable to common stockholders for 2017 was approximately $15.0 million, or $1.07 per share based on 14.0 million shares outstanding, compared with a net loss attributable to common stockholders for 2016 of approximately $9.4 million, or $2.14 per share based on 4.4 million shares outstanding. The results include non-cash, stock-based compensation expense of approximately $0.8 million in 2017 and $0.5 million in 2016.
Balance Sheet Highlights
Cash and cash equivalents as of December 31, 2017 were approximately $10.0 million, compared with approximately $11.4 million as of December 31, 2016. During the fourth quarter of 2017 Cellectar raised net proceeds of approximately $7.1 million in a registered direct offering of common stock and Series B preferred stock, as well as a private placement of Series D warrants.
Management believes that current cash and cash equivalents are sufficient to fund budgeted operations into the first quarter of 2019.
Conference Call
Cellectar will host a conference tomorrow beginning at 8:30 a.m. Eastern Time to review the financial results, provide a company update and answer questions.
Shareholders and other interested parties may participate by dialing 844-751-1093 (U.S.) or 574-990-2954 (international) and providing conference ID 6674595. The call will also be broadcast live on the Internet via the Company’s website at View Source
For those unable to participate in the live conference call or webcast, a replay will be available beginning March 22, 2018 two hours after the close of the conference call. To access the replay, dial 855-859-2056 or 404-537-3406. The replay passcode is 6674595.
The webcast will be archived on the Company’s website for 90 days.
About Phospholipid Drug Conjugates
Cellectar’s product candidates are built upon a patented delivery and retention platform that utilizes optimized PDCs to target cancer cells. The PDC platform selectively delivers diverse oncologic payloads to cancerous cells and cancer stem cells, including hematologic cancers and solid tumors. This selective delivery allows the payloads’ therapeutic window to be modified, which may maintain or enhance drug potency while reducing the number and severity of adverse events. This platform takes advantage of a metabolic pathway utilized by all tumor cell types in all cell cycle stages. Compared with other targeted delivery platforms, the PDC platform’s mechanism of entry does not rely upon specific cell surface epitopes or antigens. In addition, PDCs can be conjugated to molecules in numerous ways, thereby increasing the types of molecules selectively delivered. Cellectar believes the PDC platform holds potential for the discovery and development of the next generation of cancer-targeting agents.