On May 11, 2018 Cellectar Biosciences (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported recent corporate highlights and financial results for the three months ended March 31, 2018 (Press release, Cellectar Biosciences, MAY 11, 2018, View Source [SID1234526526]).

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Recent Corporate Highlights

·Received orphan drug designation and rare pediatric disease designation from the U.S. Food and Drug Administration (FDA) for CLR 131 to treat neuroblastoma.

·Received orphan drug designation from the FDA for CLR 131 to treat rhabdomyosarcoma, a rare pediatric cancer.

·Presented Phase 1 study results at the 12th World Congress of the World Federation of Nuclear Medicine and Biology demonstrating that CLR 124 is able to cross the blood-brain barrier and achieve uptake in brain tumors. The company believes these data have positive read through for CLR 131 which varies only by the radionuclide delivered.

·Initiated 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 R/R B-cell hematologic cancers.

·Initiated cohort 5 in the Phase 1 study of CLR 131 in highly pretreated R/R multiple myeloma patients. This is the first cohort in the trial to use a fractionated dosing schedule.

·Presented two late-breaking poster presentations at the AACR (Free AACR Whitepaper) Annual Meeting. The posters highlighted the potential benefits of fractionated dosing regimens of CLR 131 and the ability of the company’s Phospholipid Drug Conjugates (PDCs) to provide improved targeting of tumor cells and the intracellular trafficking of these molecules.

·Granted seminal U.S. patent for phospholipid-ether analogs covering composition of matter and method of use for proprietary PDCs in combination with anti-cancer agents.

·Issued U.S. patent entitled "Alkylphosphocholine analogs for multiple myeloma imaging and therapy," covering the use of CLR 131 in multiple MM and received a composition of matter patent in Japan.

"The first quarter and recent weeks brought significant progress on both the clinical and regulatory fronts. We advanced both Phase 1 and Phase 2 studies for CLR 131, presented new data at major scientific conferences, and received orphan drug designation and rare pediatric disease designation from the FDA to treat neuroblastoma in pediatric patients, as well as an orphan drug designation to treat rhabdomyosarcoma," said James Caruso, president and CEO of Cellectar Biosciences. "We are particularly excited to begin our upcoming Phase 1 study to explore CLR 131 as a treatment option for children with life-threatening rare pediatric cancers."

First Quarter 2018 Financial Results

Research and development expense for the first quarter of 2018 was $2.1 million, compared with $1.9 million for the first quarter of 2017. The year over year increase is attributable to higher preclinical and clinical project costs, manufacturing, and general research and development costs.

General and administrative expense for the first quarter of 2018 was $1.3 million, compared with $1.0 million for the first quarter of 2017. The year over year increase is attributable to higher consulting, legal and marketing fees, as well as one-time personnel costs incurred in connection with the decision to outsource our manufacturing.

The net loss attributable to common stockholders for the first quarter of 2018 was $3.5 million, or $0.21 per share based on 16.8 million shares outstanding, compared with a net loss attributable to common stockholders for the first quarter of 2017 of $2.9 million, or $0.24 per share based on 12.0 million shares outstanding.

Cash and cash equivalents as of March 31, 2018 were $6.8 million, compared with $10.0 million as of December 31, 2017.

On May 11, 2018 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that Christian Hogg, Chief Executive Officer, will present at the Bank of America Merrill Lynch 2018 Health Care Conference on Wednesday, May 16, 2018 at 1:00 pm PDT in Las Vegas (Press release, Hutchison China MediTech, MAY 11, 2018, View Source [SID1234526527]).

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The presentation and Q&A session will be webcast live and can be accessed at www.chi-med.com in the Shareholder Information section under "Events, Circulars & Forms." Investors interested in listening to the live webcast should log on before the start time to download any software required. A replay of the event will be available shortly thereafter, for 90 days.

On May 11, 2018 Radius Health, Inc. (Nasdaq:RDUS) reported that Jesper Høiland, President and Chief Executive officer and Pepe Carmona, Senior Vice President and Chief Financial Officer of the Company, will present a corporate update at the Bank of America Merrill Lynch 2018 Annual Healthcare Conference on Tuesday, May 15, 2018 (Press release, Radius, MAY 11, 2018, View Source [SID1234526549]).

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Information on the presentation is as follows:

Event: Bank of America Merrill Lynch 2018 Annual Healthcare Conference
Date: Tuesday, May 15, 2018
Time: 1:40 p.m. PDT
Location: Encore Hotel, Las Vegas, NV
A live webcast of the presentation will be available by visiting the Investors section of Radius’ website at View Source A replay of the webcast will be archived on Radius’ website for 30 days following the presentation

On May 11, 2018 Leap Therapeutics, Inc. (NASDAQ:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, reported financial results for the first quarter ended March 31, 2018 (Press release, Leap Therapeutics, MAY 11, 2018, View Source;p=RssLanding&cat=news&id=2348662 [SID1234526528]).

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"We had a strong first quarter, as we presented data from our study of DKN-01 as a monotherapy and in combination with KEYTRUDA (pembrolizumab) in patients with esophagogastric cancer, and dosed the first patients in new trials for both of our programs," commented Christopher K. Mirabelli, Ph.D, President and Chief Executive Officer of Leap Therapeutics. "We also successfully completed a public offering, strengthening our balance sheet and enabling further growth of the company."

Recent Pipeline Highlights:

DKN-01:

Completed enrollment of the dose escalation phase and presented interim data of a clinical trial evaluating DKN-01 and KEYTRUDA (pembrolizumab) in patients with advanced esophagogastric cancer. Data from the dose escalation phase indicated that the combination was well tolerated with early signals of clinical activity. In the high-dose DKN-01 cohort, one of four evaluable patients naïve to anti-PD-1/PD-L1 therapy had a partial response with a 66% reduction in target tumor volume. This patient has a tumor phenotype which is typically less responsive to anti-PD-1 therapy. The study is now enrolling two expansion cohorts in patients with esophagogastric cancer who are naïve to anti-PD-1/PD-L1 therapy (n=40) and patients who are refractory to anti-PD-1/PD-L1 therapy (n=15).
Presented data on the monotherapy activity of DKN-01 in patients with advanced esophagogastric cancer. Of 16 patients evaluable by central imaging analysis, two patients had a partial response and five patients had stable disease, representing a total disease control rate of 43.8%. One patient who had failed prior investigational immunotherapies had a partial response on DKN-01 monotherapy and remained on study for over a year.
Enrolled the first patients in a clinical study evaluating DKN-01 as a monotherapy and in combination with paclitaxel in patients with endometrioid gynecologic cancers, a population of cancers with frequent alterations of the Wnt signaling pathway resulting in increased expression of DKK1.
TRX518:

Enrolled the first patients in a clinical trial evaluating TRX518 in combination with gemcitabine chemotherapy or in combination with KEYTRUDA (pembrolizumab) or Opdivo (nivolumab), anti-PD-1 therapies marketed by Merck (known as MSD outside the United States and Canada) or Bristol-Myers Squibb, respectively.
Business Highlights

Completed a public offering for $16.1 million in gross proceeds, which supports further growth of the company and extends the cash runway into the fourth quarter 2019.
DKN-01 Program Update Call:

On Friday, May 18, 2018 at 12:00PM ET Leap will be hosting a conference call and webcast for the investment community with DKN-01 clinical investigators where the Company will provide a program update. To access the conference call, please dial (866) 589-0108 (US/Canada Toll-Free) or (409) 231-2048 (international) and refer to conference ID 7196723. The presentation will also be webcast live and will be available under "Events & Presentations" in the Investor section of the Company’s website, View Source A replay of the webcast will be available on the Company’s website approximately two hours after the event and will be available for a limited time.

Selected First Quarter 2018 Financial Results

Net loss was $10.6 million for the first quarter 2018, compared to $9.4 million for the same period in 2017. This increase was primarily due to a non-cash change in the fair value of the warrant liability offset by a decrease in stock-based compensation expense.

Research and development expenses were $4.2 million for the first quarter 2018, compared to $6.4 million for the same period in 2017. This decrease was primarily due to a decrease in stock-based compensation expense and a decrease in manufacturing costs related to clinical trial material.

General and administrative expenses were $2.1 million for the first quarter 2018, compared to $3.8 million for the same period in 2017. This decrease was primarily due to a decrease in stock-based compensation expense and a decrease in legal, audit and consulting fees.

Cash, cash equivalents and marketable securities totaled $35.4 million at March 31, 2018. Research and development incentive receivables, current and long term, totaled approximately $1.6 million at March 31, 2018.

On May 11, 2018 RXi Pharmaceuticals Corporation (NASDAQ: RXII) reported that it has entered into a research collaboration with Iovance Biotherapeutics to evaluate the potential synergies with RXi’s novel sd-rxRNA therapeutic compounds and Iovance’s autologous cell therapy based on tumor-infiltrating lymphocytes (TILs) for the use in the treatment of cancer (Press release, RXi Pharmaceuticals, MAY 11, 2018, View Source [SID1234526530]).

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Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals, stated: "Iovance is the leading company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology. Our agreement will allow Iovance to explore their proprietary TIL technology and our proprietary sd-rxRNA technology. Under this research collaboration, we will further investigate and expand the recently published data with TIL and sd-rxRNA products, which demonstrated potentially enhanced tumor killing activity of TIL." He added that: "As such, we may be able to improve potency of the TIL product and also possibly broaden the applicability of TIL in other tumors types. We see this new research collaboration with the highly experienced Iovance team using TIL, as a major step to advance life-saving treatment approaches for solid tumors, a space where there is still a dire need for improved therapies for these patients."