On February 7, 2019 Emergent BioSolutions Inc. (NYSE: EBS) reported that it will host a conference call on Thursday, February 21, 2019 at 5:00 pm (Eastern Time) to discuss the financial results for the fourth quarter and full year 2018, recent business developments, financial outlook for full year 2019, and revenue guidance for the first quarter of 2019 (Press release, Emergent BioSolutions, FEB 7, 2019, View Source;p=RssLanding&cat=news&id=2386590 [SID1234533165]).

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This conference call can be accessed live by telephone or by webcast:

Live Teleconference Information:
Dial in number: (855) 766-6521
International dial in: (262) 912-6157
Conference ID: 2299983

Live Webcast Information:
Visit View Source for the live webcast feed.
A replay of the call can be accessed on Emergent’s website emergentbiosolutions.com under "Investors."

On February 7, 2019 For more than three decades, American Skin Association (ASA) and its affiliates reported that have funded more than $50 million in grants to address the causes and treatments of melanoma, vitiligo, and psoriasis, as well as other skin diseases, and to search for much-needed cures (Press release, American Skin Association, FEB 7, 2019, View Source [SID1234554047]). Today, ASA continues its tradition of awarding significant research grants by funding 18 promising new grants for 2019.

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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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This year, the much sought-after ASA Milstein Research Scholar Award for Melanoma/Non-melanoma Skin Cancer has been awarded to Neda Nikbakht, MD, PhD, Assistant Professor of Dermatology and Cutaneous Biology at Thomas Jefferson University in Philadelphia for her research on Genomic Profiling of Early Stage Cutaneous T-cell Lymphoma.

ASA renewed its commitment to Roger Lo, MD, PhD of the David Geffen School of Medicine at UCLA. Dr. Lo is midway through his work on a three-year award of the Abby S. and Howard P. Milstein Innovation Award for Melanoma/Non-Melanoma Skin Cancer Research (MIA). The grant of $750,000 was initially funded in 2018 and focuses on the field of cancer genetics and genomics, using next generation sequencing approaches to uncover the basis of resistance to both molecularly targeted therapies and immune checkpoint inhibitors.

These grants were made possible through the generosity of the Milstein Family. Howard P. Milstein, Chairman of ASA, and his family are devoted to funding vital dermatological research in an effort to discover cures for skin cancers and diseases.

"We are proud to continue our funding of crucial research through ASA. Although the skin is our largest and perhaps most vulnerable organ, dermatological research remains one of the most underfunded areas of medicine," said Mr. Milstein. "Through these grants we improve the chances of finding cures and bring hope to those suffering from devastating skin diseases."

Dr. Roger Lo, the MIA awardee, said, "I am very grateful for the continued generosity of Howard Milstein and his family. My lab is conducting patient-oriented melanoma research, the knowledge from which we will be able to use to directly impact patient management and care. This would not be possible without the support of individuals like Mr. Milstein."

ASA’s Medical Advisory Committee (MAC) is comprised of leading physicians and scientists who oversee the annual grant review and award process. Through MAC’s leadership, ASA’s grant program has supported the work of nearly 300 investigators, ranging from talented young researchers in the early phases of their careers to recognized leaders in the field of dermatology.

ASA President and Co-Chair of its MAC, Dr. David A. Norris, added, "We have a wonderful group of grant awardees this year. ASA’s Medical Advisory Committee is excited for the future findings of these important studies."

ASA provides significant special research awards to established investigators and medical students studying melanoma, non-melanoma skin cancer and skin diseases. Through these grants, ASA has promoted the early careers of many gifted young investigators and has had a profound impact both on dermatology research and clinical care of dermatologic disease. In particular, ASA-funded researchers have had a broad impact on melanoma research, improving our understanding of its diagnosis, treatment, and prognosis. With an exclusive focus on skin disease research, ASA has helped open new frontiers in skin science, producing results that can change how we understand and treat skin disease.

On February 7, 2019 Bristol-Myers Squibb Company (NYSE: BMY) reported that it will take part in a fireside chat at the Guggenheim Healthcare Talks Idea Forum on Thursday, February 14, 2019, in New York (Press release, Bristol-Myers Squibb, FEB 7, 2019, View Source [SID1234533113]). Giovanni Caforio, M.D., chairman and chief executive officer will answer questions at 11:00 a.m. ET.

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Investors and the general public are invited to listen to a live webcast of the session at View Source Materials related to the presentation will be available at the same website at the start of the live webcast. An archived edition of the session will be available later that day.

On February 7, 2019 Median Technologies (Paris:ALMDT), The Imaging Phenomics Company reported preliminary and unaudited financial results for the full year 2018, a year of successful transition that has led to the reconfiguration of the company into two separate business units, iCRO and iBiopsy, and to the realignment of its workforce and business activities with clarified strategic objectives (Press release, MEDIAN Technologies, FEB 7, 2019, View Source [SID1234533131]).

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During 2018, Median increased its focus on its iBiopsy platform, its next generation of medical imaging platform based on best-in-class technology, including image processing, cloud computing and artificial intelligence to improve targeting of current patient treatments, enhancing diagnostics and accelerating the development of next generation therapies. With the unprecedented growth in healthcare data, the iBiopsy platform’s imaging, analytical and machine learning functionalities will permit healthcare providers to derive insights from multi-omics data to reduce healthcare costs, develop personalized medicine, and manage patient care proactively. Median Technologies has grouped all of its science and development activities into its iBiopsy business unit. The iBiopsy business unit represented more than 40% of the company’s overall headcount as of December 31, 2018.

In 2018, the company’s revenues were generated by the iCRO business unit. Median decided to focus the majority of its iCRO activities on the high growth Chinese market and closed certain non-profitable activities. The restructuring of the iCRO business unit has allowed the company to dramatically reduce costs, improve margins and Median is targeting breakeven in 2019 for this part of the business. Even though 2018 company’s revenues were €6.3m, a decrease of 17.5% compared to 2017, the iCRO business is now not only stable but should see strong growth through conversion of it increased backlog and as part of this its focus on the Chinese market.

As of December 31, 2018, the company’s order backlog was €23.7m, an increase of 10.8% compared to the backlog on June 30, 2018. During the second half of the year, Median signed up many of the leading Chinese pharmaceutical companies including major contracts for phase III clinical trials. The Chinese market is experiencing extremely strong growth given that Chinese pharmaceutical companies have been able to raise substantial amounts of funding for clinical trials through successful IPO’s. Median has benefited in China from the fact that there are no legacy or established relationships with local or International iCROs competing with the company; consequently, Median has experienced a strong market penetration by demonstrating a high quality of customer service. Median expects this growth to continue over the next few years and the company should gain further repeat business from existing customers. At the end of 2018, 39.2% of the order backlog was coming from Chinese business vs 5.4% in 2017. Over 75% of 2018 gross new business originated from China. Median’s strategic Chinese investor, Furui Medical Science Company, has been instrumental in supporting the growth in the Chinese market.

The company’s cash and cash equivalents were €12.7m as of December 31, 2018. The strategic restructuring into two business units and an increased focus on high growth and profitable markets has enabled the cash burn to decrease substantially during the second semester of 2018 with a cash burn of €5.8m versus €9.8m during the first semester of 2018. Excluding exceptional charges related to the company’s organizational changes, the cash burn would have decreased even more.

"In 2018 we have repositioned our iCRO business to allow Median to deliver on its promise of sustained profitable growth. We expect good growth in the years to come particularly in China and the rest of the Asia-Pacific region", said Fredrik Brag, CEO, Chairman and co-founder of Median Technologies. "Healthcare is being transformed by AI and cloud computing and as a technology company Median is very well positioned to profit from these disruptive changes in the delivery of healthcare through its groundbreaking iBiopsy imaging phenomics platform. In 2018 a new breed of data driven technology companies have emerged in the US and even though they are at an early stage of development, they have attracted large amounts of funding and generated significant market value based on the projected impact on drug development and patient treatment. We fully expect to leverage our unique technology in this rapidly emerging market and we look forward to a very exciting 2019".

The Company expects to announce full 2018 financial results on April 11, 2019, after market close.

The preliminary results set forth above are based on management’s initial review of the Company’s operations for the year ended December 31, 2018 and are subject to revision based upon the Company’s year-end closing procedures and upon the completion and external audit of the Company’s year-end financial statements. Actual results may differ materially from these preliminary results as a result of the completion of year-end closing procedures, final adjustments and other developments arising between now and the time that the Company’s financial results are finalized, and such changes could be material. In addition, these preliminary results are not a comprehensive statement of the Company’s financial results for the fourth quarter or full year ended December 31, 2018, should not be viewed as a substitute for full, audited financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the Company’s results for any future period.

On February 7, 2019 Myovant Sciences (NYSE: MYOV), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of women’s health and endocrine diseases, reported corporate updates and reported financial results for the third fiscal quarter ended December 31, 2018 (Press release, Myovant Sciences, FEB 7, 2019, http://investors.myovant.com/news-releases/2019/02-07-2019-210634214 [SID1234533114]).

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"As we enter this new year, we look forward to our first Phase 3 data from our LIBERTY program in uterine fibroids. The recent approval by Takeda for Relumina (relugolix 40 mg tablets) for the treatment of uterine fibroids in Japan, further validates our belief in relugolix as a critical treatment for people with uterine fibroids in the U.S. and Europe," said Lynn Seely, M.D., President and Chief Executive Officer of Myovant Sciences. "We continue to be on track to deliver data from both our LIBERTY and HERO programs this year, however enrollment for our SPIRIT endometriosis studies has taken longer than anticipated. While we remain confident that enrollment will be completed in 2019, we now anticipate top-line data for SPIRIT will be available in the first quarter of next year."

Recent Business Highlights and Upcoming Milestones

Relugolix Phase 3 Clinical Programs

Completed patient enrollment in the Phase 3 LIBERTY 2 trial evaluating relugolix in combination with estradiol and a progestin in women with heavy menstrual bleeding associated with uterine fibroids.
Expect top-line data from LIBERTY 1 and LIBERTY 2 Phase 3 trials evaluating the safety and efficacy of relugolix in combination with estradiol and a progestin in women with heavy menstrual bleeding associated with uterine fibroids in Q2 and Q3 of 2019, respectively, and assuming positive data, submission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in Q4 of 2019.
Expect top-line data from the HERO Phase 3 trial evaluating the safety and efficacy of relugolix in men with advanced prostate cancer in Q4 2019, and assuming positive data, submission of the NDA to the FDA in early 2020.
Expect completion of enrollment in both SPIRIT 1 and SPIRIT 2 Phase 3 trials evaluating the safety and efficacy of relugolix in women with pain associated with endometriosis this year, with top-line data expected in Q1 2020.
On January 8, 2019, Takeda Pharmaceutical Company Limited and ASKA Pharmaceutical Co., Ltd. announced that Takeda has obtained marketing authorization in Japan from the Ministry of Health, Labour and Welfare for Relumina Tablets 40 mg (generic name: relugolix) for the improvement of symptoms of uterine fibroids (heavy menstrual bleeding, lower abdominal pain, lower back pain, and anemia).
MVT-602 Clinical Program

Completed enrollment in the dose-finding pharmacokinetic/pharmacodynamic Phase 2a study of MVT-602, a kisspeptin-1 receptor agonist, in healthy women undergoing a controlled ovarian stimulation protocol. Top-line results are expected to be reported in the first half of 2019.
Corporate

Raised proceeds of $92.0 million pursuant to our existing financing arrangement with NovaQuest in late December 2018.
Third Fiscal Quarter 2018 Financial Summary

Research and development (R&D) expenses for the quarter ended December 31, 2018, were $58.4 million compared to $34.9 million for the comparable period in 2017. The increase for the quarter primarily reflects the progress of Myovant’s ongoing Phase 3 clinical trials of relugolix, which were initiated in 2017, as well as additional personnel-related expenses and MVT-602 clinical trial expenses.

General and administrative (G&A) expenses for the quarter ended December 31, 2018, were $10.7 million compared to $6.6 million for the comparable period in 2017. The increase for the quarter primarily reflects increases in personnel-related expenses, professional service fees, and other administrative expenses to support Myovant’s headcount growth and expanding operations.

Net interest expense for the quarter ended December 31, 2018, was $1.6 million compared to $0.9 million in the comparable prior year period. Net interest expense consists of interest expense related to financing agreements with NovaQuest and Hercules Capital, Inc., as well as the associated non-cash amortization of debt discount and issuance costs, partially offset by interest income earned on cash equivalents.

Net loss for the quarter ended December 31, 2018, was $70.6 million, compared to $41.8 million for the comparable period in 2017. On a per common share basis, net loss was $1.04 and $0.70 for the quarters ended December 31, 2018, and 2017, respectively. The increases in the net loss and net loss per common share for the quarter were driven primarily by the increase in costs outlined above.

Capital resources: Cash and cash equivalents totaled $183.0 million at December 31, 2018. An additional $40.6 million of capacity remains available under the "at-the-market" equity offering program that Myovant initiated in April 2018.

About Relugolix

Relugolix is an oral, once-daily, small molecule that acts as a gonadotropin-releasing hormone, or GnRH, receptor antagonist. More than 2,150 study participants have received treatment with relugolix in Phase 1, Phase 2 and Phase 3 clinical trials. In completed trials, relugolix was generally well tolerated and suppressed estrogen and progesterone levels in women and testosterone levels in men. Common side effects observed were consistent with suppression of these hormones.

In the ongoing Phase 3 LIBERTY clinical trials in women with heavy menstrual bleeding associated with uterine fibroids and the ongoing Phase 3 SPIRIT clinical trials in women with pain associated with endometriosis, relugolix is undergoing evaluation in combination with estradiol and norethindrone acetate, a progestin, and as monotherapy. Myovant is studying whether the combination optimizes estradiol levels to the range required to treat the signs and symptoms of endometriosis and uterine fibroids while minimizing the side effects associated with low estrogen levels, which include bone mineral density loss and hot flashes. The ongoing Phase 3 HERO study is evaluating relugolix monotherapy in men with advanced prostate cancer.

About MVT-602

MVT-602 is an oligopeptide kisspeptin-1 receptor agonist. Kisspeptin, the ligand, is a naturally-occurring peptide that stimulates GnRH release and is required for puberty and maintenance of normal reproductive function, including production of sperm, follicular maturation and ovulation, and production of estrogen and progesterone in women and testosterone in men. A Phase 2a clinical trial in healthy female volunteers to characterize the dose-response curve in the controlled ovarian stimulation setting has completed enrollment.