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Myovant Provides Corporate Updates and Reports Financial Results for Third Fiscal Quarter Ended December 31, 2018

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, View Source [SID1234533141]).

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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.

ESSA Pharma Provides Corporate Update and Reports Financial Results for Fiscal First Quarter Ended December 31, 2018

On February 7, 2019 ESSA Pharma Inc. ("ESSA" or the "Company") (TSX-V: EPI,NASDAQ: EPIX), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported financial results for the fiscal first quarter ended December 31, 2018 (Press release, ESSA, FEB 7, 2019, View Source [SID1234533140]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

"Following the preclinical work on a select group of our next generation aniten compounds showing high potency, metabolic stability, predicted long half-lives and superior pharmaceutical properties we are on track to make a final IND candidate selection in the first calendar quarter of 2019, and enter the clinic as expeditiously as possible after our IND submission," stated David Parkinson, MD, President and CEO of ESSA. "We look forward to presenting two posters at the 2019 Genitourinary Cancers Symposium on February 14, 2019, which will be the first public presentation of preclinical data from ESSA’s new aniten compounds."

Recent Company Highlights

Otello Stampacchia, Ph.D., founder of Boston-based biotech and medical device investment firm, Omega Funds LP, was appointed to the Company’s Board of Directors in October 2018.
The Company was accepted to present a poster at AACR (Free AACR Whitepaper) Annual Meeting, March 29 – April 3, 2019 in Atlanta, GA.
The Company will present at the 31st Annual ROTH Conference, March 17-18, 2019 in Laguna Niguel, CA.
Summary Financial Results

Net Income (Loss). ESSA recorded a net loss of $2.7 million ($0.42 loss per common share based on 6,305,283 weighted average common shares outstanding) for the quarter ended December 31, 2018, compared to a net loss of $2.1 million ($1.44 loss per common share based on 1,455,094 weighted average common shares outstanding) for the quarter ended December 31, 2017, which included a gain on derivative liability of $7.3 million.
Research and Development ("R&D") expenditures. R&D expenditures for the quarter ended December 31, 2018 were $1.2 million compared to $1.0 million for the quarter ended December 31, 2017. The increases in R&D expenditures for the quarter were primarily related to ESSA’s continued focus on preclinical research related to the Company’s next-generation aniten compounds in the current period. Costs in the comparative period included termination costs in relation to ESSA’s conclusion of its Phase I clinical study of EPI-506 in September 2017.
General and administration ("G&A") expenditures. G&A expenditures for the quarter ended December 31, 2018 were $1.2 million compared to $1.0 million for the quarter ended December 31, 2017. The increases in the quarter primarily reflected increased corporate activity, resulting in increased professional fees, compensation expenses and increased share-based payments reflecting the vesting and granting of stock options.
Liquidity and Outstanding Share Capital
Cash on hand at December 31, 2018, was $12.2 million, with working capital of $9.2 million, reflecting the aggregate gross proceeds of the completed January 2018 financing, , which totalled $26 million, less operating expenses in the intervening period.

As of December 31, 2018, the Company had 6,311,098 common shares issued and outstanding, and 1,654,000 common shares issuable on the exercise of prepaid warrants at a nominal exercise price of $0.002 per common share. If all prepaid warrants are exercised, there would be approximately 7,965,098 ESSA common shares outstanding.

In addition, as of December 31, 2018 there were 474,937 common shares issuable upon the exercise of warrants and broker warrants at a weighted-average exercise price of $34.35 per ESSA common share and 911,961 ESSA common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $4.79 per common share.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Five Prime Therapeutics to Announce Fourth Quarter and Full Year 2018 Financial Results and Host Conference Call on February 26

On February 7, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported that it will report its fourth quarter and full year 2018 financial results on Tuesday, February 26, 2019, after the U.S. financial markets close (Press release, Five Prime Therapeutics, FEB 7, 2019, View Source [SID1234533139]). Five Prime will host a conference call and live audio webcast on Tuesday, February 26, 2019 at 4:30 p.m. (ET)/1:30 p.m. (PT) to discuss the company’s financial results and provide a general business update.

The live audio webcast may be accessed through the "Events & Presentations" page in the "Investors" section of the company’s website at www.fiveprime.com. Alternatively, participants may dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID: 9689855.

The archived conference call will be available on Five Prime’s website beginning approximately two hours after the event and will be archived and available for replay for at least 30 days after the event.

Harpoon Therapeutics Announces Pricing of Initial Public Offering

On February 7, 2019 Harpoon Therapeutics, Inc. ("Harpoon"), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported the pricing of its initial public offering of 5,400,000 shares of its common stock at a price to the public of $14.00 per share (Press release, Harpoon Therapeutics, FEB 7, 2019, View Source [SID1234533138]). The gross proceeds to Harpoon from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by Harpoon, are expected to be $75.6 million. The shares are expected to begin trading on the Nasdaq Global Select Market on February 8, 2019 under the symbol "HARP." The offering is expected to close on February 12, 2019, subject to customary closing conditions. In addition, Harpoon has granted the underwriters a 30-day option to purchase up to an additional 810,000 shares of common stock.

Citigroup and SVB Leerink are acting as joint book-running managers for the offering. Canaccord Genuity and Wedbush PacGrow are acting as co-managers for the offering.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission and was declared effective on February 7, 2019. The offering is being made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained, when available, from: Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

Gossamer Bio Announces Pricing of Initial Public Offering

On February 7, 2019 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported the pricing of its initial public offering of 17,250,000 shares of common stock at a public offering price of $16.00 per share (Press release, Gossamer Bio, FEB 7, 2019, View Source [SID1234533137]). The shares are expected to begin trading on the Nasdaq Global Select Market on February 8, 2019 under the ticker symbol "GOSS." All of the shares are being offered by Gossamer Bio. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Gossamer Bio, are expected to be $276.0 million. The offering is expected to close on February 12, 2019, subject to satisfaction of customary closing conditions. In addition, Gossamer Bio has granted the underwriters a 30-day option to purchase up to an additional 2,587,500 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

BofA Merrill Lynch, SVB Leerink, Barclays and Evercore ISI are acting as joint book-running managers for the offering.

Registration statements relating to the shares being sold in this offering have been filed with the Securities and Exchange Commission and became effective on February 7, 2019. The offering will be made only by means of a prospectus. Copies of the prospectus may be obtained from BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; or from SVB Leerink, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; or from Barclays, c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (888) 603-5847, or by email at [email protected]; or from Evercore ISI, Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction