10-Q – Quarterly report [Sections 13 or 15(d)]

Johnson & Johnson has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Adaptimmune Reports Third Quarter 2017 Financial Results and Business Updates

On November 2, 2017 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in T-cell therapy to treat cancer, reported financial results and business updates for the quarter ended September 30, 2017 (Press release, Adaptimmune, NOV 2, 2017, View Source [SID1234521468]).

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“We announced in September that GSK had exercised its option over our NY-ESO program and the transition to GSK is well underway. We continue to enroll patients in NY-ESO studies in indications such as the multiple myeloma combination study with KEYTRUDA and MRCLS,” commented James Noble, Chief Executive Officer at Adaptimmune. “Adaptimmune will receive up to $61 million over the course of the transition period, which extends our ability to fund the business through to early 2020. This provides us with a clear runway to deliver clinical data from our ongoing trials for each of our wholly-owned assets MAGE-A10, MAGE-A4, and AFP. I am pleased to say that we are on track to release initial safety data from MAGE-A10 in early 2018.”

Recent Corporate Highlights:

· Funded through to early 2020 by means of financing activity in the first half of 2017 as well as the recent NY-ESO option exercise by GSK. The NY-ESO option exercise will provide up to $61 million (£48 million) over the course of the transition period (expected completion during 2018).
· Presented positive data across all four cohorts of synovial sarcoma patients at ASCO (Free ASCO Whitepaper), and GSK exercised the NY-ESO option based on strength of these data
· Nearing completion of manufacture-readiness at the Navy Yard facility in Philadelphia
· Relocated UK operations to new long-term laboratories and offices
· Sébastien Desprez joined the Company as Vice President of Communications and Investor Relations

Financial Results for the Three Months ended September 30, 2017

· Cash / liquidity position: As of September 30, 2017, Adaptimmune had cash and cash equivalents of $145.3 million and Total Liquidity(1) of $231.9 million. This includes payments received during the quarter relating to the NY-ESO option exercise by GSK of $28.5 million (out of up to $61 million receivable during the transition period).
· Revenue: Revenue represents the upfront and milestone payments, which are recognized over the estimated period the Company delivers services to GSK. Revenue for the three months ended September 30, 2017 was $27.2 million, compared to $2.4 million for the same period of 2016. The increase in revenue is due in part to the $9.1 million of milestone payments being achieved in the

(1) Total liquidity is a non-GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below.

1


three months ended September 30, 2017 and a reduction in the estimate of the period over which certain services are to be delivered to GSK due to exercise of the NY-ESO Option resulting in an increase in cumulative revenue amortization of $17.5 million in September 2017.
· Research and development (“R&D”) expenses: R&D expenses for the three months ended September 30, 2017 were $24.0 million, compared to $15.6 million for the same period of 2016. The increase was primarily due to increased costs associated with clinical trials; costs of developing manufacturing capability in the Company’s U.S. facility and increased personnel expenses.
· General and administrative (“G&A”) expenses: G&A expenses for the three months ended September 30, 2017 were $8.1 million, compared to $5.4 million for the same period of 2016. The increase was primarily due to increased personnel costs, share-based compensation expense and IT infrastructure costs in accordance with the Company’s planned growth.
· Net loss: Net loss attributable to holders of the Company’s ordinary shares for the three months ended September 30, 2017 was $0.9 million ($(0.00) per ordinary share) compared to $18.5 million ($(0.04) per ordinary share) in the same period of 2016.

Financial Guidance

The Company believes that its existing cash and cash equivalents, marketable securities and income from GSK upon transition of the NY-ESO program will fund the Company’s current operating plan through to early 2020.

Revenue for the three months ended September 30, 2017 includes the impact of cumulative adjustments to revenue amortization for milestones achieved in the quarter and of the change in estimate of the period over which revenue is recognized. This is not anticipated to recur in the three months ended December 31, 2017.

Conference Call Information

The Company will host a live teleconference and webcast to provide additional details at 8:00 a.m. EDT (12:00 p.m. GMT) today, November 2, 2017. The live webcast of the conference call will be available via the events page of Adaptimmune’s corporate website at www.adaptimmune.com. An archive will be available after the call at the same address. To participate in the live conference call, if preferred, please dial (877) 280-1254 (U.S.) or +44 (0)20 3450 9987or 0800 279 4992 (U.K.). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (3625348).

Pieris Pharmaceuticals to Host Third Quarter 2017 Investor Call and Corporate Update on November 9, 2017

On November2, 2017 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for cancer, respiratory and other diseases, reported that will host a Q3 2017 Investor Call on Thursday, November 9, 2017 at 10:00 AM (EST) to discuss financial results and provide a corporate update.

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To access the call, participants may dial 877-407-8920 (US & Canada) or 412-902-1010 (Intern(Press release, Pieris Pharmaceuticals, NOV 2, 2017, View Source [SID1234521487])ational) at least 10 minutes prior to the start of the call.

An archived replay of the call will be available for 30 days by dialing (Toll Free US & Canada): 877-660-6853, (International): 201-612-7415, Conference ID #: 13661472.

AVIRAGEN THERAPEUTICS REPORTS FIRST QUARTER OF FISCAL YEAR 2018 FINANCIAL RESULTS

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.

10-Q – Quarterly report [Sections 13 or 15(d)]

Progenics Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Progenics Pharmaceuticals, 2017, NOV 2, 2017, View Source [SID1234521499]).

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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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