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.

On November 2, 2017 Aviragen Therapeutics, Inc. (NASDAQ:AVIR) reported its financial results for the three months ended September 30, 2017 (Press release, Nabi Biopharmaceuticals, NOV 2, 2017, View Source [SID1234521518]).

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“Earlier this week we were pleased to announce the culmination of our strategic review process with the signing of a definitive merger agreement with Vaxart, which we believe complements Aviragen’s focus on infectious diseases. With recently reported positive safety and efficacy data in both influenza and norovirus, Vaxart is well-positioned to create both short and long-term value for our stockholders,” said Joseph M. Patti, Ph.D., President and Chief Executive Officer of Aviragen Therapeutics. “Post-merger, we believe that Vaxart will be well funded to advance its norovirus and HPV oral tablet vaccine programs, and together with BTA074, the combined companies are poised to provide several meaningful value creation clinical data readouts.”

Corporate Update:

Proposed Merger with Vaxart:

The exchange ratio in the merger agreement was determined by Vaxart assigning $60,000,000 in value to Aviragen for its financial and clinical assets, and $90,000,000 in value for its own assets. On a pro forma basis after giving effect to the number of shares of Aviragen common stock issued to Vaxart security holders in the merger, current Vaxart security holders will own approximately 60% of the combined company and current Aviragen security holders will own approximately 40% of the combined company. The transactions have been approved by the boards of directors of both companies. The merger is expected to close in the first quarter of calendar year 2018, subject to the approval of the stockholders of each company as well as other customary conditions.

Upon closing of the transaction, the name of the combined company will become Vaxart, Inc. and shares of the combined company are expected to continue trading on the NASDAQ Capital Market under the proposed ticker symbol VXRT. Wouter Latour, M.D., will serve as Chief Executive Officer of the combined company.




BTA074 (teslexivir):

The Phase 2 trial of BTA074, a topical antiviral treatment for condyloma caused by human papillomavirus (HPV), is ongoing and the Company anticipates that enrollment in the 210 patient trial will be completed in the fourth quarter of calendar year 2017. Top-line safety and efficacy data is expected in the second quarter of calendar year 2018.

Financial Results for the Three Month Period Ended September 30, 2017

The Company reported a net loss of $5.3 million for the three month period ended September 30, 2017, as compared to a net loss of $10.0 million in the same quarter of the prior fiscal year. Basic and diluted net loss per share was $0.14 for the three month period ended September 30, 2017, as compared to a basic and diluted net loss per share of $0.26 in the same period in 2016. The major components of net loss in both periods are detailed below.

Revenue was $0.1 million for the three month periods ended September 30, 2017 and 2016. The 2017 revenue relates to $0.1 million in non-cash royalty revenue related to certain royalty rights that were sold to HealthCare Royalty Partners III, L.P. (HCRP) in April 2016 and the cash will be passed through to HCRP. The 2016 revenue was comprised of $0.1 million in Relenza royalties.

Research and development expense decreased to $2.8 million for the three month period ended September 30, 2017 from $7.6 million in the same period in 2016. The $4.8 million decrease largely reflected reduced clinical trial activity and manufacturing costs as two of our three Phase 2 clinical trials finished in the third quarter of fiscal 2017.

General and administrative expense increased to $2.3 million for the three month period ended September 30, 2017 from $2.2 million for the same period in 2016 due mostly to higher legal fees.

The Company held $34.1 million in cash, cash equivalents, and short-term investments as of September 30, 2017.