On November 8, 2018 Seres Therapeutics, Inc. (NASDAQ:MCRB) reported third quarter 2018 financial results and provided an operational update (Press release, Seres Therapeutics, NOV 8, 2018, View Source [SID1234530954]).

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"Based on a growing body of promising clinical data and preclinical data from our laboratories and others, Seres has increased its strategic focus toward immunology and immuno-oncology, and we are very pleased to have hired Kevin Horgan, M.D., an expert in these key areas, as our new Chief Medical Officer. Kevin has led the development and approval of numerous important drugs, and he has an ideal background to drive the Company’s clinical programs forward," said Roger J. Pomerantz, M.D., President, CEO and Chairman of Seres. "Seres has also been working to expedite data read outs from the ongoing SER-109 clinical study for recurrent C. difficile infection, and the soon-to-be initiated SER-287 Phase 2b study for ulcerative colitis. In addition, Seres and our collaborators at MD Anderson Cancer Center and the Parker Institute for Cancer Immunotherapy have taken significant steps to advance our SER-401 immuno-oncology program toward the clinic."

Recent Highlights and Events

SER-109 ECOSPOR III Phase 3 Study: Enrollment for ECOSPOR III remains ongoing with approximately 100 clinical sites open across the U.S. and Canada. Study enrollment has been impacted by the widespread availability of unapproved fecal microbiota transplantation. The Company is considering alternatives, including study design modification, to expedite the availability of clinical results. Based on ECOSPOR III screening to date, 38% of subjects screened have had a negative C. difficile toxin test, despite having a positive C. difficile PCR test. In agreement with recent clinical guidelines, these subjects were deemed to not have an active C. difficile infection and were not eligible for study inclusion. These data provide additional support for our important requirement of a positive toxin test implemented in ECOSPOR III, and suggest that C. difficile clinical studies relying on PCR-based testing alone may include a significant proportion of subjects without active disease.
New data supporting SER-109 activity presented at ID Week 2018 conference: SER-109 data from the completed Phase 2 study provided insights into the potential mechanism of action of microbiome therapeutics for C. difficile infection. Presented results showed that SER-109 administration led to changes in the metabolic products created by the microbiome, including higher concentrations of secondary bile acids thought to be inhibitory to C. difficile growth.
SER-287 development activity: The Company has made operational progress towards initiating a SER-287 Phase 2b clinical study in patients with active mild-to-moderate ulcerative colitis (UC). To expedite the time and resources required to obtain top-line results from this study, the Company has modified the previously planned four-arm placebo-controlled study design into a smaller, three-arm study in approximately 200 patients that will include two different doses of SER-287, both following pretreatment with oral vancomycin, and a placebo arm. Seres has designed this study as a potentially pivotal trial, and the Company is awaiting feedback from the FDA on this final study design.

Based on modification to the Nestlé Health Science collaboration agreement, Seres now expects to receive $40 million in milestone payments from Nestlé Health Science following initiation of the SER-287 Phase 2b study. Because the SER-287 Phase 2b study could serve as a pivotal trial, the parties agreed that at initiation of the SER-287 Phase 2b study Seres would receive $40 million in contractual payments corresponding to both the Phase 2 milestone and a payment of the Phase 3 milestone.
SER-401 immuno-oncology development activity: In collaboration with the Parker Institute for Cancer Immunotherapy and MD Anderson Cancer Center, Seres is continuing activities to prepare the evaluation of the potential for SER-401 to augment checkpoint inhibitor response in patients with metastatic melanoma.
New Chief Medical Officer: Seres appointed Kevin Horgan, M.D., as Executive Vice President and Chief Medical Officer. Dr. Horgan will lead Seres’ clinical development, clinical operations, regulatory affairs, and medical affairs functions, and report directly to Dr. Pomerantz. He succeeds Seres’ outgoing Chief Medical Officer, Michele Trucksis, Ph.D., M.D., who will continue to provide clinical consulting services to the Company. Over a three-decade academic and industry career, Dr. Horgan has contributed to the development and approval of multiple therapeutics across immunology and oncology indications. Most recently, Dr. Horgan was Vice President of Clinical Development at AstraZeneca where he led the development of combination immuno-oncology programs. Dr. Horgan earned his medical degree from University College Cork in Ireland and did his medical residency at The Johns Hopkins Hospital in Baltimore, Maryland.
Financial Results

Seres reported a net loss of $21.9 million for the third quarter of 2018, as compared to a net loss of $6.9 million for the same period in 2017. The third quarter net loss was driven primarily by clinical and development expenses, personnel expenses, and ongoing development of the Company’s microbiome therapeutics platform. The third quarter net loss figure was inclusive of $9.1 million in recognized revenue primarily associated with the Company’s collaboration with Nestlé Health Science.

Research and development expenses for the third quarter were $23.7 million, as compared to $22.2 million for the same period in 2017. The research and development expenses were primarily related to Seres’ microbiome therapeutics platform, the clinical development of SER-109, SER-262 and SER-287, as well as the Company’s SER-301, SER-155 and immuno-oncology preclinical programs.

General and administrative expenses for the third quarter were $7.6 million, as compared to $8.1 million for the same period in the prior year. General and administrative expenses were primarily due to headcount, professional fees, and facility costs.

The decrease in cash, cash equivalents and investments balance during the quarter was $23.2 million. Seres ended the third quarter with approximately $72.9 million in cash, cash equivalents and investments. Current resources, that do not include $40 million of milestone payments that the Company expects to receive following the initiation of the SER-287 Phase 2b study, are expected to fund the Company into the second quarter of 2019.

Conference Call Information

Seres’ management will host a conference call today, November 8, 2018, at 8:30 a.m. ET. To access the conference call, please dial 844-277-9450 (domestic) or 336-525-7139 (international) and reference the conference ID number 9877087. Accompanying slides will be made available on the Seres website prior to the call. To join the live webcast, please visit the "Investors and Media" section of the Seres website at www.serestherapeutics.com.

A webcast replay will be available on the Seres website beginning approximately two hours after the event and will be archived for at least 21 days.

On November 8, 2018 Marker Therapeutics, Inc. (NASDAQ: MRKR), a clinical-stage immuno-oncology company, reported that its President and CEO, Peter L. Hoang, will participate in three upcoming healthcare conferences. Mr. Hoang will participate in a panel discussion titled "Drug Pricing and Development Challenges" at the CEO Life Sciences and Pharmaceuticals Symposium on November 13, 2018 in New York City, and will give corporate overviews at the Piper Jaffray 30th Annual Healthcare Conference on November 27, 2018 in New York City and at the Evercore ISI HealthconX Conference on November 28, 2018 in Boston (Press release, Marker Therapeutics, NOV 8, 2018, View Source [SID1234530974]).

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November Conferences
November Conferences
CEO Life Sciences and Pharmaceuticals Symposium
Title: Drug Pricing and Development Challenges
Date: Tuesday, November 13, 2018
Time: 5:00pm – 6:30pm (EST)
Location: Yellow Room, 107 East 16th Street, New York City

Piper Jaffray 30th Annual Healthcare Conference
Date: Tuesday, November 27, 2018
Time: 12:00pm – 12:25pm (EST)
Location: Lotte New York Palace, Holmes 1, 4th Floor

Evercore ISI HealthconX Conference
Date: Wednesday, November 28, 2018
Time: 10:35am – 10:55am (EST)
Location: Boston Harbor Hotel, South Atlantic Room, 2nd Floor

Webcasts for the Piper Jaffray and Evercore ISI conferences will be made available at View Source

On November 8, 2018 Stemline Therapeutics, Inc. (Nasdaq: STML), a biopharmaceutical company focused on the development and potential commercialization of novel oncology therapeutics, reported financial results for the quarter ended September 30, 2018 (Press release, Stemline Therapeutics, NOV 8, 2018, View Source [SID1234531049]). The Company also reviewed recent clinical and regulatory events, and outlined key upcoming milestones:

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ELZONRIS – Potential Approval and Pre-Commercial Activities

The FDA accepted, for filing, the Company’s Biologics License Application (BLA) for ELZONRISTM (tagraxofusp; SL-401) for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The FDA also granted Priority Review for the BLA and set a target action date of February 21, 2019, under the Prescription Drug User Fee Act (PDUFA).
In preparation for potential US approval, we continue to build out our pre-launch activities. These efforts include ramping up our disease awareness campaign targeting key stakeholders including hematologist-oncologists, dermatologists, and pathologists.
During the quarter, we conducted meetings with our assigned Rapporteurs and the European Medicines Agency (EMA). Based on feedback from these meetings, we plan to submit a Marketing Authorization Application (MAA) to the EMA for ELZONRIS in the first quarter of 2019 seeking marketing approval in Europe.
ELZONRIS – Market Expansion Efforts

ELZONRIS is being evaluated in clinical trials in additional indications, with a focus on chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF).
Based on the clinical results observed in CMML and MF thus far, we are finalizing registrational plans in these indications. We plan to seek regulatory advice in early 2019 with the goal of initiating pivotal trials, or cohorts, to follow. Ahead of this, the ongoing trial continues to enroll CMML and MF patients, and periodic updates at upcoming conferences will be provided.
ASH Conference

At the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) conference in December, ELZONRIS data were selected for four presentations, including an oral presentation. Presentations include results of the BPDCN pivotal trial and updated clinical trial data in patients with chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF).
Additionally, we expect to have a robust clinical, medical affairs and pre-commercial presence at ASH (Free ASH Whitepaper), including hosting an investor/analyst event on December 3rd.
SL-801

In October, data from the ongoing Phase 1 trial of SL-801 in patients with advanced solid tumors were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress 2018.
Patient enrollment and dose escalation continues. We expect to provide further updates at upcoming conferences.
SL-701

In October, data from the Phase 2 trial of SL-701 in patients with second-line glioblastoma (GBM) were delivered via oral presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress 2018.
Discussions around next steps to unlock potential value from the program are ongoing, and we expect to provide further updates at upcoming conferences.
Ivan Bergstein, M.D., CEO of Stemline Therapeutics, commented "This is an extremely exciting time for Stemline, as we gear up for the possible approval and near-term launch of ELZONRIS for BPDCN. We have nearly completed the full build-out of our U.S. sales force and commercial infrastructure in preparation for potential launch of ELZONRIS. In parallel, we continue to generate very promising clinical data in CMML and MF, additional areas of unmet medical need. Overall, the ability to effectively target CD123 with an acceptable safety profile we believe opens up significant developmental and commercial opportunities for Stemline."

Third Quarter 2018 Financial Results Review

Stemline ended the third quarter of 2018 with $78.5 million in cash, cash equivalents and investments, representing cash use of $18.6 million in the third quarter. The Company ended the third quarter of 2018 with 31.7 million shares outstanding. For the third quarter of 2018, Stemline had a net loss of $21.0 million, or $0.73 per share, compared with a net loss of $16.1 million, or $0.68 per share, for the same period in 2017.

Research and development expenses were $11.8 million for the quarter ended September 30, 2018, compared with $12.4 million for the quarter ended September 30, 2017.

General and administrative expenses were $9.6 million for the quarter ended September 30, 2018, compared with $4.2 million for the quarter ended September 30, 2017, representing an increase of $5.4 million. The higher expenses were primarily attributed to a $4.6 million increase in pre-launch expenses to support a potential commercialization of ELZONRIS in BPDCN, if marketing approval from the FDA is obtained. Additionally, the higher expense was also due to an increase in non-cash stock-based compensation and increased headcount.

About BPDCN
Please visit the BPDCN disease awareness booth (#205) at ASH (Free ASH Whitepaper) 2018, and the BPDCN disease awareness website at www.bpdcninfo.com.

On November 8, 2018 Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle) product platform, reported that management will present a company update at the Jefferies 2018 London Healthcare Conference (Press release, Bicycle Therapeutics, NOV 8, 2018, View Source [SID1234530956]). The presentation will take place at 5:20 p.m. GMT on Thursday, November 15, 2018.

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On November 8, 2018 Perrigo Company plc (NYSE; TASE: PRGO) reported financial results for the third quarter ended September 29, 2018 (Press release, Perrigo Company, NOV 8, 2018, View Source [SID1234530975]).

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Refer to Tables I – VI at the end of this press release for a reconciliation of non-GAAP measures to the current year and prior year periods and additional non-GAAP information. The Company’s reported results are included in the attached Condensed Consolidated Statements of Operations, Balance Sheets and Statements of Cash Flows.

Reported net sales for the third quarter of calendar year 2018 were approximately $1.1 billion, which included new product sales of $35 million, partially offset by discontinued products of $9 million. Adjusted net sales decreased 5.7% on a constant currency basis. Unfavorable currency movements impacted net sales by $12 million.

Reported net loss was $68 million, or $0.49 per diluted share, versus net income of $45 million, or $0.31 per diluted share, in the prior year. Excluding charges as outlined in Table I, third quarter 2018 adjusted net income was $150 million, or $1.09 per diluted share, versus adjusted net income of $197 million, or $1.39 per diluted share, for the same period last year.

CHC Americas segment reported net sales were relatively flat compared to last year. Strong net sales in the smoking cessation, infant formula and dermatological categories coupled with new product sales of $13 million, were offset by lower net sales in the animal health and gastrointestinal categories and discontinued products of $1 million. Excluding the animal health business, net sales in the CHC Americas segment grew approximately 3%, on a constant currency basis.

CHC Americas third quarter reported gross profit margin was 31.0%. Adjusted gross profit margin was 32.7%, lower than the prior year due primarily to the animal health business, operating inefficiencies and relatively higher input costs.

Reported third quarter operating margin was (20.8)%. Third quarter adjusted operating margin was 19.0%, lower than the prior year due primarily to adjusted gross margin flow through.

CHC International net sales increased approximately 1%, excluding $2 million in net sales from exited businesses in 2017 and unfavorable foreign currency movements of $10 million. Growth was driven by net sales in the analgesic, anti-parasite and personal care categories in addition to new product sales of $19 million. Partially offsetting this growth were lower net sales in the lifestyle category and non-branded U.K. businesses. Discontinued products were $5 million.

Third quarter reported gross margin was 46.6%. Adjusted gross margin increased 120 basis points over the previous year to 52.6%, driven primarily by adjusted gross margin improvement initiatives including new product margin contributions.

Reported operating margin was (0.6)%. Adjusted operating margin expanded 230 basis points to 18.7% driven by gross margin flow through and improved operating leverage
RX reported net sales of $179 million were lower due primarily to challenging market dynamics in a number of authorized generic products and customer service challenges, resulting in lower sales volumes. Discontinued products were $4 million.

Reported gross margin was 41.0%. Adjusted gross margin was 52.3%, 260 basis points lower than the same quarter last year, due primarily to unfavorable product mix.

Reported operating margin was 20.1%. Adjusted operating margin was 31.9% compared to 42.4% in the prior year, due primarily to a 580 basis points increase in R&D investments as a percentage of net sales, compared to the prior year and adjusted gross margin flow through. R&D as a percentage to net sales was approximately 11% in the quarter.

Impairment

During the three months ended September 29, 2018, the animal health reporting unit continued to experience declines in its year-to-date financial results and had additional indications of impairment due to changes in channel dynamics, a strategic decision to re-prioritize our brands, and a decline in the forecasted outlook of the reporting unit. As a result, the Company realized an impairment in goodwill and intangible assets in this reporting unit within CHC Americas of approximately $213 million.

Guidance

The Company now expects calendar year 2018 net sales to be approximately $4.72 billion. The Company also expects calendar year 2018 adjusted diluted EPS in the range of $4.45 to $4.65, primarily due to revised expectation in the RX segment. In addition, reduced margin expectations in the CHC Americas segment are expected to be partially offset by improved margin expectations in the CHC International segment.

Conference Call

The Company will host a conference call at 8:30 a.m. EST (5:30 a.m. PDT), November 8, 2018. The conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 888-317-6003, International 412-317-6061, and reference ID #4651574. A taped replay of the call will be available beginning at approximately 12:00 p.m. (EST) Thursday, November 8, until midnight November 15, 2018. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 10125751.