On November 2, 2017 Cerus Corporation (NASDAQ:CERS) reported financial results for the third quarter ended September 30, 2017 (Press release, Cerus, NOV 2, 2017, View Source [SID1234521512]).

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Recent developments include:

Announced national German reimbursement for pathogen-inactivated platelets starting January 1, 2018. Germany is the largest platelet market in Europe with approximately 575,000 units manufactured each year.
Entered into a new supply agreement for the INTERCEPT Blood System for platelets with Centro de Transfusión de la Comunidad (CTCM), one of the largest blood banks in Spain.
Entered into new Italian distribution agreement for INTERCEPT with Kedrion, a global manufacturer and distributor of plasma derivatives, headquartered in Italy.
Announced first Biologics License Application (BLA) approval for U.S. blood center customer.
“I am encouraged by the commercial progress we are making as an organization. The highlight of the third quarter was clearly the rapid deployment of illuminators by the Établissement Français du Sang (EFS), the French National Blood Service,” said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. “With Illuminators now deployed at all French regional blood centers, it gives us greater conviction on our ability to potentially drive revenue growth in the coming quarters. Coupled with the recent national German reimbursement for pathogen-inactivated platelets, we believe we are gaining significant momentum in Europe’s two largest markets for platelets. In addition, with the continued market adoption of INTERCEPT in the U.S., we believe that we are well positioned to grow the business globally. We are also tightening our 2017 product revenue guidance to $41 million to $43 million compared to our previous guidance range of $40 million to $46 million.”

Product Revenue

Product revenue for the third quarter of 2017 was $10.8 million, up 6% compared to $10.2 million recognized during the same period in 2016. The increase in reported product revenue for the quarter was driven primarily by a 12% increase in worldwide demand for platelet kits and an increase in illuminator sales, which were partially offset by a decline in plasma kit sales.

Product revenue for the first nine months of 2017 was $27.3 million, up 1% compared to the first nine months of 2016 of $27.1 million. In addition to an increase in illuminator sales, year-to-date demand for platelet kits was up 15%. These increases were offset by declines in plasma kit sales.

Gross Margins

Gross margins on product revenue for the third quarter of 2017 were 50%, compared to 46% for the third quarter of 2016. Gross margins for the first nine months of 2017 were 51%, compared to 46% for the first nine months of 2016. Gross margins in the quarter benefitted from the increased demand for INTERCEPT platelet products which generate higher gross margins than plasma products, and favorable Euro foreign exchange rates quarter-over-quarter and year-over-year.

Operating Expenses

Total operating expenses for the third quarter of 2017 were $20.1 million, compared to $19.2 million for the third quarter of 2016. Total operating expenses for the first nine months of 2017 were $66.0 million, compared to $59.0 million for the first nine months of 2016. Selling, general and administrative expenses were flat in the third quarter compared to the comparable period in the prior year. Selling, general, and administrative expenses increased for nine months ended September 30, 2017, over the comparable period in 2016, primarily driven by increased commercial activity in the U.S. Research and development expenses increased in both periods primarily due to clinical development activities of our INTERCEPT red blood cell system, and in particular, activities related to our BARDA contract.

Operating and Net Loss

Operating losses during the third quarter of 2017 were $12.4 million, compared to $14.3 million for the third quarter of 2016, and $46.7 million compared to $46.3 million for the nine months ended September 30, 2017 and September 30, 2016, respectively.

Net loss for the third quarter of 2017 was $13.4 million, or $0.12 per diluted share, compared to a net loss of $14.4 million, or $0.14 per diluted share, for the third quarter of 2016. Net loss for the first nine months of 2017 was $49.1 million, or $0.46 per diluted share, compared to a net loss of $49.4 million, or $0.49 per diluted share, for the same period of 2016.

Net loss for the nine months ended September 30, 2017 was positively impacted by the gain of approximately $3.5 million, due to the sale of the Company’s marketable equity investment in Aduro Biotech, Inc (“Aduro”). This gain was offset by non-cash income tax expense of $3.9 million recorded in the nine months ended September 30, 2017, due to the sale of the Company’s shares of Aduro.

Cash, Cash Equivalents and Investments

At September 30, 2017, the Company had cash, cash equivalents and short-term investments of $59.6 million compared to $71.6 million at December 31, 2016.

QUARTERLY CONFERENCE CALL

The Company will host a conference call and webcast at 4:15 p.m. Eastern time today to discuss its financial results and provide a general business overview and outlook. To access the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing 866-235-9006 (U.S.) or 631-291-4549 (international).

A replay will be available on the company’s website, or by dialing 855-859-2056 (U.S.) or 404-537-3406 (international) and entering conference ID number 82994688. The replay will be available approximately three hours after the call through November 16, 2017.

On November 2, 2017 Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology therapies, reported financial results for the third quarter ended September 30, 2017, and provided a business update (Press release, Corvus Pharmaceuticals, NOV 2, 2017, View Source [SID1234521513]).

“We continue to advance the clinical development of our lead product candidate, CPI-444, and other product candidates in our pipeline,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “We continue to enroll patients with renal cell cancer (RCC) and non-small cell lung cancer in expansion cohorts of our Phase 1/1b trial for both single agent and combination therapy with atezolizumab. For RCC, protocol-defined criteria for a second expansion to 48 patients from 26 has been achieved. Updated clinical and biomarker data has been accepted for oral presentation at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting in National Harbor, MD. in November.”

RECENT ACHIEVEMENTS AND UPCOMING MILESTONES
Clinical and Preclinical

Continued enrolling patients in four expansion cohorts in the ongoing disease-specific expansion part of the Phase 1/1b clinical study of CPI-444, the Company’s lead oral checkpoint inhibitor. The expanded cohorts include treatment with CPI-444 both as a single agent and in combination with atezolizumab (Tecentriq), an anti-PD-L1 antibody, in renal cell cancer (RCC) and non-small cell lung cancer (NSCLC). For both single agent and combination RCC cohorts, the protocol-defined criteria for a second expansion of the cohorts from 26 to 48 patients has been met.
Additional data from the ongoing CPI-444 study will be presented by Jason J. Luke, M.D., FACP, Assistant Professor of Medicine, University of Chicago Medicine at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting in November 2017.
Expect initial patient enrollment in the fourth quarter 2017 in a previously announced second collaboration agreement with Genentech to evaluate CPI-444 in combination with atezolizumab in a Phase 1b/2 clinical study as second- or third-line therapy in patients with NSCLC who are resistant/refractory to prior anti-PD-(L)1 antibody therapy.
Continued to progress the anti-CD73 antibody program toward Phase 1 study initiation, which is expected in the first half of 2018.
Have selected oral ITK inhibitor lead candidate that is now in IND enabling studies.
FINANCIAL RESULTS
At September 30, 2017, Corvus had cash, cash equivalents and marketable securities totaling $99.7 million compared to cash, cash equivalents and marketable securities of $134.9 million at December 31, 2016.

Research and development expenses for the three months ended September 30, 2017, totaled $10.7 million compared to $7.7 million for the same period in 2016. The increase of $3.0 million was primarily due to an increase of $2.8 million in outside clinical trial costs associated with the Phase 1/1b clinical trial for CPI-444.

General and administrative expenses for the three months ended September 30, 2017, totaled $2.2 million compared to $2.8 million for the same period in 2016. The decrease of $0.6 million was primarily due to a decrease of $0.6 million in patent and related costs.

The net loss for the three months ended September 30, 2017, was $12.7 million compared to $10.3 million for the same period in 2016. Total stock compensation expense for the three months ended September 30, 2017, was $1.5 million compared to $1.3 million for the same period in 2016.

On November 2, 2017 IntelGenx Technologies Corp., (TSX VENTURE:IGX)(OTCQX:IGXT), reported that it will release its third quarter 2017 financial results after market close on November 9, 2017 (Press release, IntelGenx, NOV 2, 2017, View Source;Conference-Call-to-Follow/default.aspx [SID1234521515]).

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An accompanying conference call will be hosted by Dr. Horst G. Zerbe, President and Chief Executive Officer, and Mr. Andre Godin, Executive Vice-President and Chief Financial Officer, to discuss the results and provide a business update. Details of the conference call and webcast are below:

Date: Thursday, November 9, 2017
Time: 4:30 p.m. ET
Conference dial-in: (833) 231-8269
International dial-in: (647) 689-4114
Conference ID: 4994849
Webcast Registration: Click here

Following the live call, a replay will be available on the Company’s website, www.intelgenx.com, under “Investor Relations”.

On November 2, 2017 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on the development of curative therapeutics using CRISPR/Cas9 technology, reported that it will present at the following upcoming healthcare conferences in November (Press release, Intellia Therapeutics, NOV 2, 2017, View Source [SID1234521516]):

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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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Tuesday, November 7, 2017
Credit Suisse 26th Annual Healthcare Conference
Who: Tom Barnes, Ph.D., Senior Vice President, Innovation Sciences
Location: Scottsdale, Arizona
Presentation Time: 9:45am MST (11:45am EST)

Wednesday, November 15, 2017
Jefferies London Healthcare Conference
Who: John Leonard, M.D., Executive Vice President, R&D
Location: London, United Kingdom
Presentation Time: 8:40am GMT (2:40am EST)

Thursday, November 30, 2017
Barclays Gene Editing/Therapy Summit
Who: Nessan Bermingham, Ph.D., Chief Executive Officer and Founder
Location: New York, New York
Presentation Time: 1:40pm EST

A live webcast of Intellia’s presentations will be accessible through the Events and Presentations page of the Investor Relations section of the company’s website at www.intelliatx.com. To access the webcasts, please log on to the Intellia website approximately 15 minutes prior to the start time to ensure adequate time for any software downloads that may be required. A replay of the webcast will be available on Intellia’s website for 14 days following each conference.

On November 2, 2017 Juniper Pharmaceuticals (Nasdaq: JNP), a diversified healthcare company focused on women’s health, reported financial results for the three-month period ended September 30, 2017 (Press release, Juniper Pharmaceuticals, NOV 2, 2017, View Source [SID1234521517]). Cash and cash equivalents were $22.1 million at September 30, 2017, an increase of 3% from June 30, 2017.

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“During the third quarter, we delivered robust revenue growth for our core businesses, CRINONE and Juniper Pharma Services (JPS), which resulted in positive cash flow for the quarter. Our third quarter G&A expense has decreased to align closer to 2016 expenses,” said Alicia Secor, Chief Executive Officer. “The strength in our core businesses provide a solid financial foundation and represents a key near-term growth driver for Juniper. We will continue to focus our resources in 2018 to maintain this momentum and drive further growth in these businesses.”

Corporate Update

Juniper Pharma Services achieved record revenues this quarter, reflecting the continued expansion of customers and service offerings.
Active discussions with partner Merck KGaA to extend the CRINONE Progesterone Gel agreement are progressing, and the expansion of this relationship remains a strategic priority for the Company.
IND-enabling preclinical studies were initiated this quarter, and results from these studies for Juniper’s IVR formulations, JNP-0101, JNP-0201 and JNP-0301, remain on track for topline preclinical data by the end of 2017. At the completion of the in vivo preclinical studies, the Company may decide to further develop JNP-0201, a combination of Estradiol plus natural progesterone IVR, for hormone replacement therapy (HRT) to address symptoms of menopause.
Partnering opportunities will be explored for JNP-0101, the oxybutynin IVR for the treatment of overactive bladder (OAB), and JNP-0301, a natural progesterone IVR for the prevention of pre-term birth (PTB) in women with a short cervical length at mid-pregnancy.
Jennifer Good was appointed to the Juniper Board of Directors, and will serve as a member of both the Audit and Compensation Committees. Ms. Good brings to the board proven executive operational experience and financial leadership.
Third Quarter Financial Results

“We continued to see strong year-over-year growth in our core business during the third quarter of 2017,” said Jeff Young, Chief Financial Officer at Juniper. “CRINONE product revenues were up 19%, and revenues from Juniper Pharma Services grew 38%, compared to the third quarter of 2016.”

Third quarter total revenues increased 12% to $13.0 million, compared with $11.6 million for the prior year quarter.

Product revenues increased by $1.3 million to $8.4 million, driven by continued in-market growth and new market sales of CRINONE by Merck KGaA, Darmstadt, Germany.

Service revenues from Juniper Pharma Services were $4.6 million, an increase of $1.3 million, or 38%, versus the third quarter of last year, driven by new and existing customer growth.

Gross profit decreased to $5.3 million as compared to $5.9 million in the quarter ended September 30, 2016. Excluding the impact of royalty revenue from the prior period, the gross profit for the quarter ended September 30, 2016 would have been $4.7 million.

Total operating expenses were $6.8 million in the third quarter of 2017, a $1.1 million increase as compared to the prior year period. This increase was primarily driven by the approximately $0.8 million restructuring charge recorded in September related to the Company’s reprioritization efforts.

Juniper’s net loss was $1.4 million, or $(0.13) per diluted share, in the third quarter of 2017, compared to a net income of $0.2 million, or $0.2 per diluted share, in the third quarter of 2016.

Liquidity
Cash and cash equivalents were $22.1 million as of September 30, 2017, versus $21.5 million at June 30, 2017.

Conference Call
As previously announced, Juniper’s management team will hold a conference call to discuss financial results for the second quarter ended September 30, 2017, as follows:

Date:
November 2, 2017
Time:
4:30 p.m. ET
Dial-in numbers:
Toll free: (866) 374-4635 (U.S.), (855) 669-9657 (Canada), or International: (412) 902-4218
Webcast (live and archive): www.juniperpharma.com, under “Investors” or click here.

The teleconference replay will be available approximately one hour after completion through Thursday, November 9, 2017, at (877) 344-7529 (U.S.), (855) 669-9658 (Canada) or (412) 317-0088 (International). The replay access code is 10113476.

The archived webcast will be available for one year via the aforementioned URLs.