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Merus to Present at the Jefferies 2018 London Healthcare Conference

On November 8, 2018 Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics), reported that Ton Logtenberg, Ph.D., President and Chief Executive Officer of Merus, will present a company overview at the Jefferies 2018 London Healthcare Conference on Thursday, November 15, 2018, at 3:20 p.m. GMT (Press release, Merus, NOV 8, 2018, View Source;p=RssLanding&cat=news&id=2376165 [SID1234532116]).

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A live webcast of the presentation will be available on the Investors and Media page of the Company’s website, View Source A replay of the presentation will be archived and available on the Merus website site for a limited time following the event.

Coherus BioSciences Reports Corporate Highlights and Third Quarter 2018 Financial Results

On November 8, 2018 Coherus BioSciences, Inc. (Nasdaq: CHRS), reported financial results for the quarter ended September 30, 2018 (Press release, Coherus Biosciences, NOV 8, 2018, View Source/news-releases/news-release-details/coherus-biosciences-reports-corporate-highlights-and-third" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-reports-corporate-highlights-and-third" rel="nofollow">View Source [SID1234531695]).

Third Quarter 2018 and Recent Corporate Highlights Include:

On September 25, 2018, the European Commission (EC) approved UDENYCA by granting marketing authorization in all European Union member states.
On November 2, 2018, the U.S. Food and Drug Administration (FDA) approved UDENYCA (pegfilgrastim-cbqv) for patients with cancer receiving myelosuppressive chemotherapy. UDENYCA is Coherus’ first drug to receive FDA or EC approval.
In preparation for a comprehensive launch of UDENYCA, Coherus completed the hiring of about 70 sales representatives covering seven territories as well as the hiring of other personnel for our commercial groups and teams.
Third Quarter 2018 Financial Results:
Research and development (R&D) expenses for the third quarter of 2018 were $31.6 million compared to $42.6 million for the same period in 2017. R&D expenses for the nine months ended September 30, 2018 were $83.6 million, as compared to $130.9 million for the same period in 2017. The decreases in R&D expenses were mainly due to the completion of our clinical trials and related manufacturing for the immunology biosimilar drug candidates, CHS-1420 (adalimumab (Humira) biosimilar) and CHS-0214 (etanercept (Enbrel) biosimilar). These cost decreases were partially offset by the costs associated with the manufacturing of UDENYCA.
General and administrative (G&A) expenses for the third quarter of 2018 were $25.4 million, compared to $14.0 million for the same period in 2017. G&A expenses for the nine months ended September 30, 2018 were $60.3 million, as compared to $56.3 million for the same period in 2017. The increases in G&A expenses in 2018 were mainly attributable to the costs associated with hiring a sales force and completing the commercial infrastructure to launch and sell UDENYCA in the U.S.
Net loss attributable to Coherus for the third quarter of 2018 was ($58.8) million, or ($0.87) per share, compared to a net loss of ($59.0) million, or ($1.09) per share, for the same period in 2017.
Cash and cash equivalents and investments in marketable securities – totaled $117.2 million as of September 30, 2018, compared to $159.8 million as of June 30, 2018. Cash use in operations of $42.8 million during the third quarter of 2018 was lower than guidance of $48 to $53 million.

Guidance for next twelve months from September 30, 2018:
UDENYCA (pegfilgrastim-cbqv), Neulasta biosimilar

Anticipate U.S. commercial launch in January 2019.
CHS-1420 (adalimumab (Humira) biosimilar)

Pursue manufacturing objectives in support of the anticipated filing of a 351(k) biologic license application (BLA) in the U.S. at the end of 2019.
CHS-3351 (ranibizumab (Lucentis) biosimilar) and CHS-2020 (aflibercept (Eylea) biosimilar)

Complete manufacturing technology transfer and continue clinical development of CHS-3351.
Continue preclinical development of CHS-2020.
CHS-131 (small molecule drug candidate in nonalcoholic steatohepatitis "NASH")

Anticipate initiation of Phase 2 clinical trial in NASH.
Conference Call Information

When: Thursday, November 8, 2018 at 4:30 p.m. ET

Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)

Conference ID: 7181479

Webcast: View Source

Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

SESEN BIO REPORTS THIRD QUARTER 2018 FINANCIAL RESULTS AND PLANNED VISTA TRIAL READOUTS

On November 8, 2018 Sesen Bio, Inc. (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of people with cancer, reported operating results for the third quarter ended September 30, 2018 and recent highlights from its development program for Vicinium for patients with high-grade non-muscle invasive bladder cancer (NMIBC) (Press release, Eleven Biotherapeutics, NOV 8, 2018, View Source [SID1234531409]).

"2018 has been a year of focused execution for Sesen Bio, led by the advancement of the Phase 3 program for Vicinium for patients with NMIBC," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "NMIBC is a devastating disease and there remains just one recommendation for patients who do not respond or become refractory to today’s standard-of-care treatment: complete bladder removal. Our goal is to help save this essential organ and provide a meaningful treatment option for patients with BCG-unresponsive NMIBC. Our Phase 3 registration clinical trial is well-designed and preliminary data reported earlier this year suggest that Vicinium is active and has a favorable safety profile, consistent with our Phase 2 experience. We look forward to assessing six-month data from the trial next month and twelve-month data in mid-2019. If the VISTA Trial is successful, we believe Viciniumcould change the treatment outlook for patients with NMIBC, bringing us closer to achieving our mission of saving and renewing the lives of patients with cancer."

Recent Highlights

In September 2018, at the Global Congress on Bladder Cancer 2018, Sesen Bio presented a biomarker update from its Phase 3 VISTA Trial data showing that all screened patient samples expressed EpCAM, the molecular target of Vicinium.
In October 2018, the company entered into an agreement with FUJIFILM Diosynth Biotechnologies U.S.A., Inc. to provide supply services in support of the manufacturing of Vicinium for the treatment of high-grade NMIBC. The Agreement facilitates a transfer of manufacturing technology from Sesen Bio to Fujifilm.
Upcoming Events

Sesen Bio anticipates reporting six-month data from the ongoing Phase 3 VISTA Trial in December 2018. A conference call will be held to review the data, with details to follow.
Third Quarter 2018 Financial Results

Cash Position: Cash and cash equivalents were $57.9 million as of September 30, 2018, compared to $11.3 million as of September 30, 2017.
Revenue: There was no revenue for the three-month periods ended September 30, 2018 and 2017, respectively, as no revenue triggering milestones were achieved during either period under the company’s license agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche).
R&D Expenses: Research and development expenses were $3.4 million for the three months ended September 30, 2018, compared to $3.6 million for the same period in 2017. The decrease was due primarily to a reduction in Vicinium-related development expenses.
G&A Expenses: General and administrative expenses were $3.8 million for the three months ended September 30, 2018, compared to $1.6 million for the same period in 2017. The increase was due primarily to an increase in professional fees as well as higher personnel-related expenses.
Net Loss: Net loss was $14.0 million, or $0.18 per share, for the three months ended September 30, 2018, compared to net loss of $9.1 million, or $0.37 per share, for the same period in 2017. The increase was due primarily to the change in the fair value of contingent consideration and increased general and administrative expenses.
Financial Guidance: Based on current operating plans, Sesen Bio believes it will have capital sufficient to fund its current operating plans into 2020.

Sierra Oncology Reports Third Quarter Results

On November 8, 2018 Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, reported its financial and operational results for the third quarter ended September 30, 2018 (Press release, Sierra Oncology, NOV 8, 2018, View Source [SID1234531378]).

"During the third quarter, we fundamentally transformed Sierra with the addition of momelotinib to our portfolio, a differentiated, demonstrably active and well-tolerated Phase 3 drug candidate for the treatment of myelofibrosis. We are currently preparing for discussions with regulators to determine the registration path for momelotinib and anticipate reporting next steps in the first half of 2019. Our anticipated registration strategy envisions a single Phase 3 trial in second line myelofibrosis patients, a population for which no approved therapies currently exist, to recapitulate the meaningful clinical benefits observed in the two previously completed SIMPLIFY Phase 3 trials, with a particular emphasis on reinforcing momelotinib’s differentiated anemia benefits," said Dr. Nick Glover, President and CEO of Sierra Oncology. "We also continue to advance our DNA Damage Response (DDR) drug candidates, SRA737 and SRA141. During the quarter, we made substantial progress enrolling genetically-selected patients into the indication specific cohorts of our two SRA737 trials, with a focus on recruiting patients with High Grade Serous Ovarian Cancer (HGSOC). We plan to report preliminary efficacy results from these trials in the first half of 2019. We also prepared for the initiation of a trial of SRA737 in combination with a PARP inhibitor in prostate cancer and for our first clinical trial with SRA141 for the treatment of colorectal cancer. We are currently evaluating the optimal timing of these trials within the context of our recently expanded portfolio."

Highlights for the Third Quarter of 2018:

Acquired momelotinib, a potent, selective and orally-bioavailable JAK1, JAK2 and ACVR1 inhibitor with a differentiated therapeutic profile in myelofibrosis.
Continued to enroll patients in the monotherapy trial for SRA737, our potent, highly selective, orally bioavailable small molecule inhibitor of Chk1. The trial is enrolling patients across five indications with a primary focus on HGSOC. Preliminary data from this trial are anticipated to be reported in the first half of 2019.
Continued to enroll patients in the combination trial of SRA737 potentiated by low dose gemcitabine, which is enrolling patients across four indications, including into a prioritized cohort of patients with HGSOC. Preliminary data from this trial are anticipated to be reported in the first half of 2019.
Prepared for the planned initiation of a Phase 1b/2 trial of SRA737 with the PARP inhibitor niraparib, which will evaluate this combination in subjects with metastatic castration-resistant prostate cancer (mCRPC).
Successfully completed the Investigational New Drug Application (IND) filing process with the U.S. Food and Drug Administration (FDA) for SRA141, our potent, highly selective, orally bioavailable small molecule inhibitor of Cdc7. The company plans to conduct a Phase 1/2 trial of the drug candidate in patients with colorectal cancer.
Third Quarter 2018 Financial Results (all amounts reported in U.S. currency)
Research and development expenses were $12.9 million for the three months ended September 30, 2018, compared to $7.4 million for the three months ended September 30, 2017. The increase was primarily due to a $3.0 million upfront fee paid to Gilead for the acquisition of our lead product candidate, momelotinib, an increase of $2.0 million in clinical trial costs and a $0.7 million increase in personnel-related and overhead costs, partially offset by a decrease of $0.2 million in research and preclinical costs related to SRA737 and SRA141. Research and development expenses included non-cash stock-based compensation of $1.2 million and $1.0 million for the three months ended September 30, 2018 and 2017, respectively.

Research and development expenses were $30.0 million for the nine months ended September 30, 2018, compared to $22.6 million for the nine months ended September 30, 2017. The increase was primarily due to a $3.0 million upfront fee paid to Gilead for the acquisition of our lead product candidate momelotinib, an increase of $5.4 million in clinical trial costs and a $1.4 million increase in personnel-related costs, partially offset by decreases of $1.5 million in third-party manufacturing costs related to SRA737 and SRA141, and $0.9 million in research, preclinical and other support costs. Research and development expenses included non-cash stock-based compensation of $3.3 million and $3.0 million for the nine months ended September 30, 2018 and 2017, respectively.

General and administrative expenses were $3.1 million for the three months ended September 30, 2018, compared to $2.8 million for the three months ended September 30, 2017. This increase was primarily due to increases in personnel-related costs, professional fees and allocated overhead. General and administrative expenses included non-cash stock-based compensation of $0.7 million and $0.5 million for the three months ended September 30, 2018 and 2017, respectively.

General and administrative expenses were $10.7 million for the nine months ended September 30, 2018, compared to $9.2 million for the nine months ended September 30, 2017. This increase was primarily due to a $1.3 million increase in personnel-related costs, professional fees and allocated overhead and a $0.2 million increase in business development costs. General and administrative expenses included non-cash stock-based compensation of $1.8 million and $1.5 million for the nine months ended September 30, 2018 and 2017, respectively.

For the three months ended September 30, 2018, Sierra incurred a net loss of $15.6 million compared to a net loss of $10.0 million for the three months ended September 30, 2017. For the nine months ended September 30, 2018, Sierra incurred a net loss of $39.1 million compared to a net loss of $31.4 million for the nine months ended September 30, 2017.

Cash and cash equivalents totaled $116.1 million as of September 30, 2018, compared to $100.3 million as of December 31, 2017. At September 30, 2018, there were 74,364,165 shares of common stock issued and outstanding, with another 10,793,266 issuable upon exercise of stock options and warrants, and a term loan of $4.9 million.

Equity Inducement Plan
On November 5, 2018, the Compensation Committee of Sierra Oncology’s Board of Directors granted non-qualified stock options to purchase an aggregate of 30,000 shares of its common stock to two new employees under Sierra Oncology’s 2018 Equity Inducement Plan.

The 2018 Equity Inducement Plan is used exclusively for the grant of equity award to individuals who were not previously an employee or non-employee director of Sierra (or following a bona fide period of non-employment), as an inducement material to such individual’s entering into employment with Sierra, pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules.

The options have an exercise price of $1.73 per share, which is equal to the closing price of Sierra’s common stock on the date of grant. Each option will vest and become exercisable as to 25% of the shares on the first anniversary of the recipient’s start date, and then will vest and become exercisable as to the remaining 75% of the shares in 36 equal monthly installments following the first anniversary, in each case, subject to each such employee’s continued employment with Sierra on such vesting dates. The options are subject to the terms and conditions of Sierra’s 2018 Equity Inducement Plan, and the terms and conditions of the stock option agreement covering the grant

Regulus Reports Third Quarter 2018 Financial Results and Recent Updates

On November 8, 2018 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, reported financial results for the third quarter ended September 30, 2018 and provided a summary of recent events (Press release, Regulus, NOV 8, 2018, View Source [SID1234531200]).

Third Quarter 2018 Corporate Highlights and Recent Updates

Amended and restructured its Collaboration and License Agreement with Sanofi: In November, Regulus and Sanofi agreed to restructure their Collaboration and License Agreement and immediately transfer development responsibilities of RG-012 for the treatment of Alport syndrome to Sanofi. Sanofi will assume all future costs and development activities associated with the advancement of RG-012, currently in Phase 2 for the treatment of Alport syndrome. Under the terms of the Amendment, Regulus is eligible to receive approximately $7 million in upfront and material transfer payments. Regulus is also eligible to receive up to $40 million in development milestone payments, including a $10 million payment for an interim enrollment milestone. In addition, Sanofi will reimburse Regulus for certain out-of-pocket expenses associated with transition activities and assume Regulus’ upstream license royalty obligations.

Initiated new chronic mouse toxicity study for RGLS4326; data anticipated in Q1 2019: In September 2018, and in consultation with the FDA, the Company initiated a new 27-week chronic mouse toxicity study for RGLS4326 for the treatment of autosomal dominant polycystic kidney disease (ADPKD), incorporating several changes believed to address the unexpected findings in the earlier terminated chronic mouse toxicity study. This study is ongoing, and data are anticipated in Q1 2019. The Company anticipates the advancement of the RGLS4326 clinical program upon successful resolution of the unexpected findings.

Completed reverse stock split and regained compliance with NASDAQ listing requirements: In a special meeting of stockholders, held September 28, 2018, stockholders voted to approve a proposal authorizing the Board of Directors of the Company to amend the Company’s certificate of incorporation to affect a reverse stock split of Regulus’ outstanding common shares. Following the special meeting of stockholders, the Board of Directors approved a 1-for-12 reverse stock split. The Company’s shares began trading on a split-adjusted basis on October 4, 2018. On October 18, 2018, The Nasdaq Stock Market notified Regulus that it had regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Global Market.

"The recently announced Sanofi restructuring represents a significant achievement for Regulus, bringing non-dilutive capital and eliminating future spend for this partnered program. Importantly, we are eligible to receive approximately $17 million in upfront and milestone payments anticipated over the next twelve months," said Jay Hagan, President and Chief Executive Officer of Regulus. "In July, we established several near-term key objectives, including reducing our cash burn, restructuring the Sanofi collaboration, advancing our prioritized pipeline, including ADPKD, and positioning other programs for business development opportunities. Regulus has made significant progress towards completing all of these objectives, and we look forward to the continued advancement of our ADPKD and HBV programs."

Program Updates

Presented preclinical data supporting RGLS4326 as a novel therapeutic for the treatment of ADPKD at the American Society of Nephrology’s Kidney Week 2018: In October 2018, Regulus presented three posters during the American Society of Nephrology’s Kidney Week describing the discovery and preclinical evaluation of RGLS4326, a novel single-stranded, chemically-modified oligonucleotide designed to preferentially target the kidney and inhibit miR-17 functions to treat ADPKD. In preclinical studies, RGLS4326 inhibited miR-17 activity and reduced cyst formation and proliferation of primary cyst cultures derived from human donors with ADPKD. The data presented also demonstrated that RGLS4326 has favorable pharmacokinetic and pharmacodynamic profiles in normal and polycystic kidney disease (PKD) mouse models, where preferential distribution to kidney and localization to collecting duct cysts were evident. Furthermore, data demonstrated that RGLS4326 directly modulates expression of genes implicated in ADPKD pathogenesis including Pkd1 and Pkd2, and conferred efficacy in multiple PKD mouse models following subcutaneous administration.

Advancement of Hepatitis B virus (HBV) Programs: The Company has identified multiple human microRNA targets that serve as host factors for the virus. Compounds directed at modulating these targets are under active in vitro and in vivo preclinical investigation. The Company believes that targeting a host factor in the liver represents a unique mechanism of action for treatment of the virus compared to other programs in development and holds the potential for achieving a functional cure. The Company currently expects to file an IND for the HBV program in the second half of 2019, with the potential of achieving human proof-of-concept in a Phase 1 study.

Additional Program Updates: In September 2018, the Company announced progress of its glioblastoma multiforme (GBM) and non-alcoholic steatohepatitis (NASH) preclinical programs. The Company’s GBM program, targeting microRNA-10b, demonstrated statistically significant improvements in survival as both a monotherapy as well as in combination with temozolomide (TMZ) in an orthotopic GBM animal model. The Company’s lead NASH candidate demonstrated improvement in key endpoints, including NAFLD Activity Score (NAS), liver transaminases, hyperglycemia, and disease-related gene expression. In the diet-induced NASH mouse model (Amylin model) after 2-4 weekly doses, early onset of improvement across multiple disease parameters including liver triglycerides and blood levels of transaminases was observed. The Company plans to seek partners to further advance these programs’ development.

Third Quarter 2018 Financial Results

Cash Position: As of September 30, 2018, Regulus had $20.5 million in cash, cash equivalents and short-term investments. Under the terms of the Sanofi Amendment, Regulus is eligible to receive approximately $7 million in upfront and material transfer payments. Including these additional proceeds, the Company expects its cash runway to extend through Q2 2019.

Research and Development (R&D) Expenses: R&D expenses were $6.9 million and $28.7 million for the three and nine months ended September 30, 2018, respectively, compared to $12.7 million and $42.7 million for the same periods in 2017. The decreases were primarily attributable to the pausing of the RG-012 and RGLS4326 programs early in the third quarter of 2018, the discontinuation of the RG-101 and RGLS5040 programs in 2017 and reductions in personnel-related expenses primarily attributable to our corporate restructurings.

General and Administrative (G&A) Expenses: G&A expenses were $3.0 million and $10.1 million for the three and nine months ended September 30, 2018, respectively, compared to $2.7 million and $13.8 million for the same periods in 2017. The increase for the three months ended September 30, 2018 as compared to the three months ended September 30, 2017 was driven by non-recurring severance charges recorded in the third quarter of 2018 in connection with our July 2018 corporate restructuring. The decrease for the nine months ended September 30, 2018 as compared to the nine months ended September 30, 2017 was driven by non-recurring severance charges and non-recurring, non-cash stock-based compensation charges recorded in connection with our May 2017 corporate restructuring.

Revenue: Revenue was less than $0.1 million for each of the three and nine months ended September 30, 2018 and 2017.

Net Loss: Net loss was $10.3 million, or $1.18 per share (basic and diluted), and $40.1 million, or $4.62 per share (basic and diluted), for the three and nine months ended September 30, 2018, respectively, compared to $15.8 million, or $2.11 per share (basic and diluted), and $57.5 million, or $10.52 per share (basic and diluted), for the same periods in 2017. Historical and current period net loss per share values have been retroactively adjusted to reflect our October 2018 reverse stock split.

Upcoming Events

On November 14, 2018, Regulus will present survival data on its lead anti-miR candidate targeting microRNA-10b for glioblastoma multiforme at the Society for Neuro-Oncology Meeting in New Orleans, Louisiana.

On November 14, 2018, Regulus will present a corporate overview at the Stifel 2018 Healthcare Conference in New York.