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 [SID1234521484]).

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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.

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.

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.

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.

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.

On November 2, 2017 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported financial results for the third quarter ended September 30, 2017 (Press release, Sunesis, NOV 2, 2017, View Source [SID1234521490]). Loss from operations for the three months ended September 30, 2017 was $9.9 million. As of September 30, 2017, cash, cash equivalents and marketable securities totaled $12.5 million. Subsequent to the end of the quarter, the company raised approximately $6 million from sales of common stock through its at the market facility in October 2017 and $20 million in gross proceeds from concurrent underwritten public offerings on October 27, 2017, which together will provide sufficient funds for the operation of the company’s business into early 2019.

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“In the third quarter, we advanced our lead program, a reversible, non-covalent BTK inhibitor, SNS-062, with the ongoing enrollment in our Phase 1b/2 study in patients with relapsed chronic lymphocytic leukemia (CLL) and other B-cell malignancies,” said Daniel Swisher, Chief Executive Officer of Sunesis. “We will provide a program update at an investor presentation and webcast during the American Society of Hematology (ASH) (Free ASH Whitepaper) Conference in Atlanta, Georgia in December 2017, and to present interim data from the study at a peer-reviewed medical conference in mid-2018. We believe SNS-062 has the potential to overcome the leading resistance pathway to ibrutinib, the predominant standard of care for the treatment of CLL. In addition, in October, we secured the financial resources from leading life science investors extending our operating runway into early 2019.

Mr. Swisher added, “Beyond SNS-062, we have made progress with our proprietary PDK-1 and Takeda-partnered pan-RAF inhibitor programs. We are pleased to announce today the nomination of our PDK1 (phosphatidyl-inositol dependent kinase1) inhibitor, SNS-510, as a Development Candidate and potentially first-to-clinic selective inhibitor in this pathway. PDK1 is a master kinase that activates other kinases important to cell growth and survival including members of the AKT, PKC, RSK and SGK families. In addition, we look forward to announcing future updates from the ongoing clinical studies of our Takeda-partnered TAK-580 program.”

Recent Highlights

Completed $20 million concurrent public offerings with leading life science investors. On October 27, 2017, Sunesis raised $20 million in gross proceeds in concurrent underwritten public offerings of common and preferred stock and warrants, with participation by new and existing investors, including Oncology Impact Fund managed by MPM Capital, BVF Partners L.P and Burrage Capital.

Continued Progress in Phase 1b/2 Study Evaluating Oral Non-Covalent BTK-inhibitor SNS-062 in Adults with Chronic Lymphocytic Leukemia (CLL) and other B-Cell Malignancies. In July 2017, Sunesis announced that the first patient was dosed at the Dana-Farber Cancer Institute in the Phase 1b/2 dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of its potent, reversible, non-covalent BTK-inhibitor, SNS-062, in adults with CLL, small lymphocytic leukemia, Waldenstrom’s macroglobulinemia, and mantle cell lymphoma. The Phase 1b/2 trial is an open-label, sequential-group study that is enrolling up to 124 subjects across leading sites in the United States. The Company plans to present interim data from this study in mid-2018.
Financial Highlights

Cash, cash equivalents and marketable securities totaled $12.5 million as of September 30, 2017, as compared to $42.6 million as of December 31, 2016. The decrease of $30.1 million was primarily due to $30.8 million of net cash used in operating activities and a debt restructuring payment of $7.6 million, partially offset by $8.3 million in net proceeds primarily from sales of common stock through the company’s at the market facility. An additional $24.6 million in net proceeds were raised in October, resulting in pro-forma September 30, 2017 cash, cash equivalents and marketable securities of $37.1 million. This capital is expected to fund the company into 2019.

Revenue for the three and nine months ended September 30, 2017 was nil and $0.7 million, as compared to $0.6 million and $1.9 million for the same periods in 2016. Revenue in each period was primarily due to deferred revenue recognized related to the Royalty Agreement with Royalty Pharma.

Research and development expense was $6.8 million and $17.9 million for the three and nine months ended September 30, 2017 as compared to $5.3 million and $18.1 million for the same periods in 2016, primarily relating to the SNS-062 and the vosaroxin development program in each period. The increase of $1.5 million between the comparable three month periods was primarily due to the $2.5 million milestone payment to Biogen under the license agreement, offset by decreases in professional services of $0.8 million and salary and personnel expenses of $0.2 million. The decrease in the comparable nine months periods of $0.2 million was primarily due to a decrease in professional services of $2.5 million, salary and personnel expenses of $0.2 million, and medical affairs expenses of $0.2 million, partially offset by the $2.5 million milestone payment to Biogen under the license agreement.

General and administrative expense was $3.2 million and $10.8 million for the three and nine months ended September 30, 2017, as compared to $3.9 million and $12.2 million for the same periods in 2016. The decrease of $0.7 million for the comparable three month periods was primarily due to decreases in salary and personnel expenses of $0.4 million and commercial expenses of $0.3 million, partially offset by increases of $0.1 million in professional services. The decrease in the comparable nine months periods of $1.4 million was primarily due to a decrease in salary and related expenses of $0.9 million, commercial expenses of $0.7 million, partially offset by increase of $0.4 million in professional services.

Interest expense was $0.3 million and $1.1 million for the three and nine months ended September 30, 2017, as compared to $0.5 million and $1.2 million for the same periods in 2016. The decrease in the 2017 periods was primarily due to the decrease in the outstanding notes payable.

Net other income was $0.1 million and $0.3 million for the three and nine months ended September 30, 2017, as compared to nil and $0.1 million for the same periods in 2016. The other income was primarily comprised of interest income from the short-term investments.

Cash used in operating activities was $30.8 million for the nine months ended September 30, 2017, as compared to $29.0 million for the same period in 2016. Net cash used in the 2017 period resulted primarily from the net loss of $28.8 million and changes in operating assets and liabilities of $4.6 million, offset by net adjustments for non-cash items of $2.6 million. Net cash used in the nine month period ended September 30, 2016 resulted primarily from the net loss of $29.5 million and changes in operating assets and liabilities of $3.6 million, including a final payment fee representing interest expense of $1.2 million under the Oxford Loan Agreement, partially offset by net adjustments for non-cash items of $4.1 million.

Sunesis reported loss from operations of $9.9 million and $28.0 million for the three and nine months ended September 30, 2017, as compared to $8.5 million and $28.4 million for the same periods in 2016. Net loss was $10.2 million and $28.8 million for the three and nine months ended September 30, 2017, as compared to $9.0 million and $29.5 million for the same periods in 2016.
Conference Call Information

Sunesis will host a conference today at 2:00 p.m. Eastern Time. The call can be accessed by dialing (844) 296-7720 (U.S. and Canada) or (574) 990-1148 (international) and entering passcode 1071001. To access the live audio webcast, or the subsequent archived recording, visit the “Investors and Media – Calendar of Events” section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company’s website for two weeks.