Radius Health to Present at the Bank of America Merrill Lynch 2018 Annual Healthcare Conference

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

Leap Therapeutics Reports First Quarter 2018 Financial Results

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.

RXi Pharmaceuticals Enters into Material Transfer Agreement with Iovance Biotherapeutics to Study its Self-Delivering RNAi Technology for the Advancement of Immuno-Oncology Therapeutics with Iovance’s Tumor Infiltrating Lymphocytes (TILs) for Solid Tumors

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."

Alkermes’ Corporate Presentation to be Webcast at the Bank of America Merrill Lynch Health Care Conference

On May 10, 2018 Alkermes plc (NASDAQ: ALKS) reported that its corporate presentation will be webcast live at the Bank of America Merrill Lynch Health Care Conference on Wednesday, May 16, 2018 at 11:20 a.m. PT (2:20 p.m. ET/7:20 p.m. BST) from Las Vegas (Press release, Alkermes, MAY 10, 2018, View Source;p=RssLanding&cat=news&id=2348542 [SID1234526463]). The presentation may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

Contact:
Jennifer Zibuda
Corporate Communications
+1 781 609 6129

Geron Corporation Reports First Quarter 2018 Financial Results

On May 10, 2018 Geron Corporation (Nasdaq: GERN) reported financial results for the first quarter ended March 31, 2018 (Press release, Geron, MAY 10, 2018, View Source [SID1234526481]).

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First Quarter 2018 Results

For the first quarter of 2018, the company reported operating revenues of $318,000 and operating expenses of $7.8 million compared to $537,000 and $8.0 million, respectively, for the comparable 2017 period. Net loss for the first quarter of 2018 was $7.2 million, or $0.04 per share, compared to $7.2 million, or $0.05 per share, for the comparable 2017 period.

Revenues for the first quarter of 2018 and 2017 included royalty and license fee revenues under various non-imetelstat license agreements. The company adopted the new revenue recognition accounting standard as of January 1, 2018 using the modified retrospective transition method. Financial results for the first quarter of 2018 are presented under the new accounting standard, but prior period amounts have not been adjusted and continue to be reported under accounting standards used historically. Therefore, there is a lack of comparability to the prior period presented. As a result, the decrease in revenues for the first quarter of 2018 compared to the same period in 2017 reflects not only a reduction in the number of active non-imetelstat license agreements and decreased product sales from licensees, but also a change in the method accounting. However, the company does not expect the adoption of the new revenue recognition accounting standard to have a material impact to its financial statements on an ongoing basis.

Research and development expenses for the three months ended March 31, 2018 and 2017 were $2.4 million and $3.4 million, respectively. The decrease in research and development expenses for the first quarter of 2018 compared to the same period in 2017 primarily reflects reduced personnel related expenses due to lower stock-based compensation expense and lower clinical development expenses under the imetelstat collaboration with Janssen Biotech, Inc. (Janssen).

General and administrative expenses for the three months ended March 31, 2018 and 2017 were $5.3 million and $4.7 million, respectively. The increase in general and administrative expenses for the first quarter of 2018 compared to the same period in 2017 primarily reflects higher consulting and legal costs associated with business development activities.

Interest and other income for the three months ended March 31, 2018 and 2017 was $394,000 and $332,000, respectively. The increase in interest and other income for the first quarter of 2018 compared to the same period in 2017 primarily reflects higher yields on the company’s marketable securities portfolio. For the three months ended March 31, 2018, the company also recognized a loss of $125,000 for the change in the fair value of an equity investment as required under a new accounting standard adopted by the company as of January 1, 2018.

The company ended the first quarter of 2018 with $103.2 million in cash and marketable securities. Subsequently, in April 2018, the company completed the sale of the remaining common stock subject to its At Market Issuance Sales Agreement (Sales Agreement). Under the Sales Agreement, the company sold a cumulative total of approximately 13.8 million shares of common stock and raised net cash proceeds of approximately $48.7 million after deducting sales commissions and offering expenses payable by Geron. No further shares of common stock can be issued under the Sales Agreement. The company expects the net cash proceeds to provide additional capital structure flexibility to potentially support (i) the future development of imetelstat in collaboration with Janssen, if Janssen elects to continue the collaboration, including potentially conducting one or more imetelstat independent development plans (IDPs) under the Collaboration Agreement; (ii) the further development of imetelstat by Geron in the event the collaboration with Janssen does not continue and Geron elects to continue development of imetelstat; or (iii) prospective in-licenses or acquisitions of other oncology products, programs or companies.

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"As we have previously announced, we expect Janssen to make its decision about whether to continue their development of imetelstat by the end of third quarter of 2018," said John A. Scarlett, M.D., Geron’s President and Chief Executive Officer. "Regardless of Janssen’s future decision, we believe imetelstat warrants further development because of the activity observed in lower risk MDS patients from Part 1 of IMerge as presented at ASH (Free ASH Whitepaper) last December, and the evolving overall survival in relapsed or refractory MF patients observed in IMbark."

Annual Meeting of Stockholders

Geron’s Annual Meeting of Stockholders will be held at 4:00 p.m. PDT / 7:00 p.m. EDT on May 15, 2018. Further information about the Annual Meeting is available on Geron’s website at www.geron.com on the homepage and in the Investors section under Events.

Due to the proximity of the Annual Meeting, Geron management will not be hosting a separate first quarter conference call.