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.

DURECT has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, DURECT, 2017, NOV 2, 2017, View Source [SID1234521496]).

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Cempra has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Cempra, 2017, NOV 2, 2017, View Source [SID1234521530]).

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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 [SID1234521469]).

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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 Liquidity1 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 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. BST) 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).

On November 2, 2017 NewLink Genetics Corporation (NASDAQ:NLNK) reported consolidated financial results for the third quarter of 2017 and provided updates on its clinical development program for indoximod, NewLink Genetics’ IDO pathway inhibitor with a distinct mechanism of action (Press release, NewLink Genetics, NOV 2, 2017, View Source [SID1234521485]).

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“We are pleased with the progress we have made advancing indoximod into our pivotal trial in melanoma. Additionally, the clinical collaboration with AstraZeneca in pancreatic cancer represents a significant step toward expanding the opportunity for indoximod beyond melanoma,” said Charles J. Link, Jr., M.D., Chairman, Chief Executive Officer, and Chief Scientific Officer. “In addition, we have recently raised new capital in an underwritten offering which significantly increases our ability to continue to execute and expand our clinical development programs.”

Recent Highlights:

Established the design of our pivotal trial for patients with advanced melanoma. The Phase 3 trial will evaluate indoximod in combination with both approved PD-1 checkpoint inhibitors, KEYTRUDA (pembrolizumab) and OPDIVO (nivolumab), in approximately 600 patients with advanced melanoma. Co-primary endpoints of the study are Progression Free Survival (PFS) by RECIST criteria and Overall Survival (OS).

Phase 2 data for indoximod plus PD-1 checkpoint inhibitor KEYTRUDA (pembrolizumab) updated for the original 51-patient advanced melanoma cohort first presented at AACR (Free AACR Whitepaper) in April demonstrated improvement in complete response rates. The Complete Response (CR) improved to 20% from 12% as the data matured, and the 12-month PFS by RECIST criteria was 56% with a median PFS (mPFS) of 12.9 months.

Entered a clinical collaboration agreement with AstraZeneca to evaluate the combination of indoximod and IMFINZI (durvalumab), AstraZeneca’s anti-PD-L1 monoclonal antibody, along with standard of care chemotherapy in a randomized, placebo-controlled Phase 2 trial for patients with metastatic pancreatic cancer.

Indoximod was granted Orphan Drug Designation by the FDA for patients with Stage IIb-IV melanoma.

Dosed the first patients with the novel salt formulation of indoximod. As planned, this was done in the ongoing Phase 1b study of indoximod in combination with standard of care chemotherapy for patients with newly diagnosed Acute Myeloid Leukemia (AML). All subsequent trials will utilize the new formulation of indoximod.

Raised $55.2 million net of expenses in underwritten public offering led by Bank of America Merrill Lynch and Stifel subsequent to the third quarter. During the third quarter, we raised an additional $19.3 million net of expenses in an “at-the-market” facility, with Cantor Fitzgerald as agent.
Guidance for remainder of 2017 and 2018:

Initiate the Pivotal trial of indoximod in combination with PD-1 checkpoint blockade for patients with advanced melanoma, with the goal of enrollment by end of 2018.

Present final results of Phase 2 trial of indoximod plus checkpoint inhibitors for patients with advanced melanoma during 2018.

Present final results of Phase 2 trial of indoximod plus gemcitabine/nab-paclitaxel for patients with metastatic pancreatic cancer at an oncology meeting 1H 2018.

Initiate the randomized Phase 2 trial of indoximod plus durvalumab plus gemcitabine/nab-paclitaxel for patients with metastatic pancreatic cancer 1H 2018.
Financial Results for the Three-Month Period Ended September 30, 2017

Cash Position: NewLink Genetics ended the third quarter with cash and cash equivalents totaling $120.7 million compared to $131.5 million for the year ending December 31, 2016.

R&D Expenses: Research and development expenses were $18.5 million in the third quarter of 2017 compared to $24.5 million in the third quarter of 2016. The decrease of $6.0 million was due primarily to a $6.2 million decline in contract research and manufacturing spend, a $500,000 decrease in personnel-related spend, and a $530,000 decline in clinical trial and other supplies, offset by an increase of $630,000 in one-time restructuring expense incurred for employee severance during the third quarter of 2017, an increase in legal and consulting spend of $370,000, and an increase in stock compensation expense of $230,000.

G&A Expenses: General and administrative expenses in the third quarter of 2017 were $7.9 million compared to $7.7 million in the third quarter of 2016. The increase of $200,000 was due to a one-time restructuring expense incurred for employee severance during the third quarter of 2017 of $1.1 million, an increase of $370,000 for supplies and other expenses, and an increase in stock compensation expense of $260,000 offset by a decline of $1.1 million in personnel-related spend, and a decline of $430,000 in consulting and legal fees.

Net Loss: NewLink Genetics reported a net loss of $20.6 million or $0.69 per diluted share for the third quarter of 2017 compared to a net loss of $15.5 million or $0.54 per diluted share for the third quarter of 2016.

NewLink Genetics ended the quarter with 31,319,751 shares outstanding.

Financial Guidance and Upcoming Investor Meetings

We expect to end 2017 with approximately $150 million in cash and equivalents.

We look forward to presenting at the Stifel Healthcare Conference in New York City on November 14th and the Jefferies Healthcare Conference in London on November 16th.

Conference Call Details

The Company has scheduled a conference call for 8:30 a.m. ET today to discuss the results and to give an update. NewLink Genetics’ senior management team will host the call, which will be open to all listeners. There will also be a question and answer session following the prepared remarks.

Access to the live conference call is available by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international) five minutes prior to the start of the call. The conference call will be webcast live and a link can be accessed through the NewLink Genetics website at View Source A replay of the call will be available for two weeks from the date of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 6198669.

About Indoximod

Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is one of the key immuno-oncology targets involved in regulating the tumor microenvironment and immune escape.

NewLink Genetics is currently evaluating indoximod in multiple combination studies for patients with various types of cancer including melanoma, pancreatic cancer and other malignancies.