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10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

PDL BioPharma has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, PDL BioPharma, 2018, MAR 16, 2018, View Source [SID1234524843]).

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Top News: Crinetics raises $63.5 million in new funds and adds to BOD

On March 16, 2018 Crinetics reported that it has completed a $63.5 million Series B financing to continue development of its lead product for acromegaly and other new therapeutics targeting rare endocrine disorders (Press release, Crinetics Pharmaceuticals, MAR 16, 2018, View Source [SID1234525095]). This funding was led by Perceptive Advisors, a New York biotech fund, and was joined by two other new investors, RA Capital and OrbiMed. The financing round also included existing investors 5AM Ventures, Versant Ventures, and Vivo Capital.

Crinetics lead program, CRN00808, focuses on developing an oral alternative to injections for patients suffering from acromegaly. This rare condition is often caused by the presence of a pituitary tumor, which causes production of too much growth hormone. The excessive hormone level causes several co-morbidities and if not adequately treated, acromegaly can lead to serious illness and become life-threatening.

FierceBiotech explains the importance of developing an oral therapeutic for this disease, "Surgery to remove the tumor is generally the first-line treatment option, but doesn’t always work. And while these non-responders can often be treated with injectables, they face lifelong injections and many face breakthrough symptoms as these drugs wear off between shots."

Xconomy noted that Crinetics has focused its technology on targeting G protein-coupled receptors (GPCRs), which sets the foundation for the Company’s other programs which aim to develop therapeutics for patients with rare disorders such as neuroendocrine tumors, hyperinsulinism, and Cushing’s disease. GPCRs can interact with and are modulated by neuropeptides, molecules that help nerve cells communicate. Too much or too little of these neuropeptides can incorrectly alter GPCR activity to result in the symptoms associated with these diseases. The Crinetics team has specialized expertise in modulating GPCR activity to achieve the correct level of signaling while reducing the desensitization to injected drugs seen by many patients with neuroendocrine disorders.

In addition to the financing, Crinetics has also welcomed three new members to its board of directors. BioSpace reported, "As part of the financing, two members of the Perceptive Advisors team have been appointed to the Crinetics Board of Directors. Weston Nichols, an analyst, and Matthew K. Furst, who has served as Senior Advisor for Perceptive, have taken the board positions. Another board change includes the departure of Vivo Capital’s Mahendra G. Shah. He will be replaced by Jack B. Nielsen, a managing director at Vivo"

Gamida Cell to Present at Upcoming Investor Conferences

On March 16, 2018 Gamida Cell, a leading cellular and immune therapeutics company, reported that the company will participate in two upcoming investor conferences (Press release, , 16 16, 2018, View Source [SID1234524862]):

Julian Adams, Ph.D., chairman and chief executive officer, will share a company overview at the Oppenheimer 28th Annual Healthcare Conference at 2:45 p.m. on Wednesday, March 21, 2018, at the Westin New York Grand Central in New York, NY. The webcast can be accessed live: https://www.veracast.com/webcasts/opco/healthcare2018/42104642533.cfm.
Dr. Adams will also present at BioCentury’s 25th Annual Future Leaders in the Biotech Industry Conference at 9:30 a.m. ET on Friday, March 23, 2018, at the Millennium Broadway Hotel & Conference Center in New York, NY. A breakout session will follow the presentation at 10:00 a.m. The webcast can be accessed live: View Source
A webcast of each presentation can be accessed through the links above, or from the News section of the Gamida Cell website

Pulse Biosciences Quarterly Investor Conference Call

On March 16, 2018 -Pulse Biosciences, Inc. (Nasdaq: PLSE), a medical technology company developing a proprietary therapeutic tissue treatment based on its Nano-Pulse Stimulation platform reported its recent corporate developments and financial results for the fiscal quarter and year ended December 31, 2017 (Press release, , 16 16, 2018, View Source [SID1234524861]).

"Nano-Pulse Stimulation induces immunogenic cell death in human papillomavirus-transformed tumors and initiates an adaptive immune response"

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Recent Developments

Successfully completed patient treatments and primary follow-up in the Company’s first clinical study evaluating Nano-Pulse Stimulation for the treatment of a benign skin condition, Seborrheic Keratosis (SK). The study resulted in the successful delivery of 472 NPS applications involving 58 patients and 174 SK lesions, with ZERO ADVERSE EVENTS reported. The data adds to the mounting evidence regarding the safety and ease with which patients can be treated with NPS for skin-based lesions. The study data is scheduled for presentation in a scientific symposium at the 38th American Society for Laser Medicine and Surgery (ASLMS) Conference on Energy-Based Medicine & Science being held April 13-15 in Dallas, Texas. The data will be made available in a press release issued in conjunction with the scientific presentation.
An additional study "A dose-response study of a novel non-thermal method of selectively modifying cellular structure in skin with low energy nanosecond electrical stimulation" was also accepted for presentation at the ASLMS Conference and awarded "BEST OF SESSION" honors by ASLMS.
Completed enrollment and follow-up on five animals in the company’s investigational feasibility study evaluating NPS for the treatment of late stage oral melanoma in canines.
Published "Nano-Pulse Stimulation induces immunogenic cell death in human papillomavirus-transformed tumors and initiates an adaptive immune response" in the peer-reviewed journal, PLOS One.
"2017 was a transformational year for Pulse Biosciences as we completed patient treatments and follow-up in our first skin lesion study, advanced our oncology program with preclinical publications and an investigational feasibility study in veterinary medicine, welcomed four new board members, and secured the financing necessary to advance our proprietary technologies," said Darrin Uecker, President and Chief Executive Officer. "We are well positioned to make significant advancements in 2018 and are most pleased with our successful SK study and look forward to sharing the results of the study in April."

Financial Highlights

Cash, cash equivalents, and investments totaled $38.1 million at December 31, 2017, compared to $16.4 million at December 31, 2016, reflects the proceeds from the $30.0 million financing completed in September of 2017, as well as the Company’s February 2017 financing. Cash use totaled $3.9 million for the fourth quarter of 2017 and $13.1 million for 2017. 2018 Cash use is currently anticipated to total $20 million.

Operating expenses for the quarter ended December 31, 2017, totaled $8.8 million, compared to $7.5 million for the quarter ended September 30, 2017, and $2.8 million for the quarter ended December 31, 2016. The operating expenses for the quarter ended December 31, 2017 included non-cash stock-based compensation of $4.5 million, compared to $3.4 million for the quarter ended September 30, 2017 and $0.2 million for the quarter ended December 31, 2016.

Conference Call Details

Pulse Biosciences’ Darrin Uecker, President and Chief Executive Officer, and other senior executives will host the investor call on March 16, 2018, at 1:30 p.m. PDT / 4:30 p.m. EDT. The telephone dial-in number for the call is (844) 494-0190 (U.S. toll-free) or (508) 637-5580 (international) using Conference ID 1487908. Listeners will also be able to access the call via webcast available on the Investors section of the Company’s website at www.pulsebiosciences.com.

MEDIGENE AG: MEDIGENE PRESENTS AT UPCOMING CONFERENCES

On March 16, 2018 Medigene AG (FSE: MDG1, Prime Standard, TecDAX) reported its participation at the following upcoming conferences (Press release, , 16 16, 2018, View Source [SID1234524860]):

Annual Needham Healthcare Conference

Date: 27 – 28 March 2018

Location: New York, USA

Dr. Thomas Taapken, CFO of Medigene, will hold a company presentation on 28 March.

analytica

Date: 10 – 13 April 2018

Location: Munich, Germany

Dr. Thomas Taapken, CFO of Medigene, takes part in a panel discussion on personalized medicine during the conference on 13 April, from 10.35am – 12pm.

American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting

Date: 14 – 18 April 2018

Location: Chicago, USA

Medigene and its clinical partners will present a poster on manufacturing data from the ongoing DC vaccine trial on April 18, 2018, 8:00 AM – 12:00 PM in Section 29. To view the abstract of the poster entitled "Generation of clinical grade autologous TLR7/8-polarized fast dendritic cell vaccines for active immunotherapy of patients with AML" please visit: View Source

German Biotechnology Days

Date: 18 – 19 April 2018

Location: Berlin, Germany

Dr. Thomas Taapken, CFO of Medigene, takes part in a panel discussion on "USA – Key market for international business" during the conference on 19 April, from 8am – 9am.

Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard, TecDAX) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies, with associated projects currently in pre-clinical and clinical development.