On November 9, 2017 Argos Therapeutics Inc. (NASDAQ:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis precision immunotherapy technology platform, reported financial results and operational highlights for the third quarter of 2017 (Press release, Argos Therapeutics, NOV 9, 2017, View Source [SID1234521853]).

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"We are pleased with the progress we have made since the second quarter, both with regard to our financial position as well as in our two clinical programs," Jeff Abbey, CEO of Argos Therapeutics, noted. "First, from a financial perspective, we are pleased to have raised approximately $10 million through our ATM facility between June and November, and to have received a $1.5 million milestone payment from our partner in China and certain other Asian territories, Lummy (Hong Kong) Ltd. In addition, as previously reported, we were pleased to reach a satisfactory resolution with one of our important vendors regarding the deferred fees that we owed them, thereby significantly extending the payment term."

Mr. Abbey continued, "From an operational perspective, we are continuing the ADAPT clinical trial, and look forward to the next interim analysis, which we expect to occur during the first half of 2018, subject to agreement with the FDA on an amended protocol. In addition, we were encouraged by the updated immunology data from the ADAPT clinical trial indicating that Rocapuldencel-T stimulated an immune response in patients with metastatic renal cell carcinoma in the trial, and by the data from the trial related to the duration of tumor response, that were presented at the European Society for Medical Oncology 2017 Congress in September. Additionally, we are continuing our study of AGS-004 in combination with the latency-reversing agent vorinostat in adult HIV patients."

Operational Highlights

During the third quarter, the Company announced the following progress:

In July 2017, the Company reported positive immunogenicity data from the AGS-004 program for the treatment of HIV
In September 2017, additional data from the Phase 3 ADAPT clinical trial was presented by Robert Figlin, MD, principal investigator, at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Conference
In September 2017, the Company announced the first dosing of an HIV patient with AGS-004 derived from the latent viral reservoir
Financial Results

Revenue for the three months ended September 30, 2017 was $53,000 compared to $147,000 for the same period in 2016. The decrease in revenue for the third quarter of 2017 compared with the third quarter of 2016 resulted from lower reimbursement under the Company’s contract with the NIH and NIAID primarily related to the achievement of certain specified development milestones under the Company’s AGS-004 program during 2016.

Research and development expense for the three months ended September 30, 2017 was $4.6 million compared to $9.3 million for the same period in 2016. The decrease in research and development expense for the third quarter of 2017 compared with the third quarter of 2016 was due to reduced expenses associated with the Phase 3 ADAPT trial, and the Company’s decision not to proceed with the development of commercial manufacturing capabilities and to significantly reduce the size of its workforce engaged in research and development activities following the recommendation of the IDMC to discontinue the ADAPT trial for futility.

General and administrative expense for the three months ended September 30, 2017 was $2.9 million compared to $3.0 million for the same period in 2016. The decrease in general and administrative expense for the third quarter of 2017 compared with the third quarter of 2016 was primarily due to reduced consulting and personnel costs.

Additionally, the Company incurred restructuring charges of $679,000 during the three months ended September 30, 2017 related to the Company’s decision to discontinue preparation for commercial manufacturing and reduce the size of its workforce, which amount was offset by a non-cash gain due to the decrease in the value of the warrant liability of $502,000 and a gain on the early extinguishment of debt of $1.5 million associated with the satisfaction and release of all of the Company’s payment obligations to Invetech, Pty Ltd.

Interest expense for the three months ended September 30, 2017 was $67,000 compared to $448,000 for the same period in 2016. The decrease in interest expense for the first three months of 2017 compared with the first three months of 2016 was primarily due to a lower average balance of debt outstanding.

Reflecting the factors noted above, net loss for the three months ended September 30, 2017 was $6.1 million compared to a net loss of $12.2 million for the same period in 2016.

Revenue for the nine months ended September 30, 2017 was $228,000 compared to $782,000 for the same period in 2016. The decrease in revenue for the first nine months of 2017 compared with the first nine months of 2016 resulted from lower reimbursement under the Company’s contract with the NIH and NIAID primarily related to the achievement of certain specified development milestones under the Company’s AGS-004 program during 2016.

Research and development expense for the nine months ended September 30, 2017 was $17.6 million compared to $28.0 million for the same period in 2016. The decrease in research and development expense for the first nine months of 2017 compared with the first nine months of 2016 was due to reduced expenses associated with the Phase 3 ADAPT trial, and the Company’s decision not to proceed with the development of commercial manufacturing capabilities and to significantly reduce the size of its workforce engaged in research and development activities following the recommendation of the IDMC to discontinue the ADAPT trial for futility.

General and administrative expense for the nine months ended September 30, 2017 was $9.5 million compared to $9.4 million for the same period in 2016. The increase in general and administrative expense for the first nine months of 2017 compared with the first nine months of 2016 was primarily due to increased personnel costs.

Additionally, the Company incurred impairment charges of $27.2 million and restructuring charges of $6.0 million during the nine months ended September 30, 2017 related to the Company’s decision to discontinue preparation for commercial manufacturing and reduce the size of its workforce, which amounts were partially offset by a non-cash gain due to the decrease in the value of the warrant liability of $20.7 million and a gain on the early extinguishment of debt of $1.8 million.

Interest expense for the nine months ended September 30, 2017 was $1.1 million compared to $1.5 million for the same period in 2016. The decrease in interest expense for the first nine months of 2017 compared with the first nine months of 2016 was primarily due to a lower average balance of debt outstanding, partially offset by the decision to no longer capitalize the interest related to construction of the Centerpoint facility following the decision not to proceed with plans to develop this facility.

Reflecting the factors noted above, net loss for the nine months ended September 30, 2017 was $38.7 million compared to a net loss of $37.7 million for the same period in 2016.

As of September 30, 2017, cash and cash equivalents totaled $9.4 million.

Upcoming Conference Call and Webcast

Argos will be presenting updated immunology data in the poster session at the 32nd Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference to be held this weekend in National Harbor, Maryland. Argos will hold a conference call to discuss this data on Monday, November 13th at 8:30am ET (rescheduled from today at 4:30pm). To participate by telephone, please dial (855) 433-0930 (Domestic) or (484) 756-4271 (International). The conference ID number is 9396519. Slides setting forth the data to be presented at the SITC (Free SITC Whitepaper) 2017 Annual Meeting, and a live and archived audio webcast, will be accessible through the Investors section of the Company’s website at www.argostherapeutics.com. The archived webcast will remain available on the Company’s website for twelve (12) months following the call.

On November 9, 2017 Altimmune, Inc. (Nasdaq:ALT), a clinical-stage immunotherapeutics company, reported financial results for the three- and nine-months ended September 30, 2017 (Press release, Altimmune, NOV 9, 2017, View Source [SID1234521852]).

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Recent Corporate Highlights

Initiated a proof-of-concept Phase 2 Flu vaccine clinical trial with the Company’s first-in-class NasoVAX vaccine, with initial data expected in 1Q-2018.
Completed enrollment in the Company’s HepTcell immunotherapeutic Phase 1 clinical trial against hepatitis B, with topline data expected in 4Q-2017.
Remained on track to initiate a BARDA-funded Phase 1 trial with NasoShield, a next-generation intranasal, single-dose, anthrax vaccine in the first quarter of 2018, with topline data anticipated in the second quarter of 2018.
Remained on track to initiate a key pre-clinical bridging study with SparVax-L, a lyophilized anthrax vaccine, in the fourth quarter. The study is fully-funded by NIAID.
Closed a Series B preferred stock offering, raising approximately $13.0 million in net proceeds
"We are pleased with the progress we have made this quarter in developing our product candidates. We are actively moving forward each of our four clinical stage assets with data readouts from all four of these programs expected within the next 8 months. We initiated a Phase 2 clinical trial with our NasoVAX flu vaccine therapy as planned this past quarter," said Bill Enright, Chief Executive Officer of Altimmune. "Additionally, we have completed enrollment in our HepTcell Phase 1 clinical trial in hepatitis B and expect to see data before the end of the year. We also remain on track in our two government-funded anthrax vaccine programs. We are excited for our upcoming milestones and thank our employees for the tremendous work and effort put forth to continue moving our programs forward."

Financial Results for the three- and nine-months ended September 30, 2017

Revenue and grants and contracts for the three- and nine-months ended September 30, 2017 were $4.6 million and $7.9 million, respectively, compared to $0.9 million and $2.2 million for the comparable periods in 2016. For the three-months ended September 30, 2017, there was a $3.0 million increase in revenue from the BARDA contract compared to the same period in 2016. Revenue and grants and contracts for the three-months ended September 30, 2017 also included $0.6 million from a contract with NIAID that was entered into by PharmAthene prior to the merger.

Research and development expenses were $5.9 million and $13.9 million for the three- and nine-months ended September 30, 2017, respectively, as compared to $2.4 million and $4.8 million for same periods in 2016. For the three-months ended September 30, 2017, there was an increase in spending on the development of the NasoShield product candidate; an increase in manufacturing and other costs in preparation for the NasoVAX Phase 2 trial; and an increase related to the addition of research and development costs of the SparVax-L asset, all of which were partially offset by a decrease in other research and development costs, compared to the same period in 2016.

General and administrative expenses were $3.0 million and $6.9 million, for the three- and nine-months ended September 30, 2017, respectively, as compared with $3.3 million and $5.3 million, in the same periods in 2016. For the three-months ended September 30, 2017, there was an increase in legal and professional costs related to the Mergers; an increase in other general and administrative expenses; an increase in general and administrative expenses related to the Mergers; and an increase in stock compensation, all of which were offset by a $2.3 million write down of deferred offering costs in September 2016, resulting in a decrease compared to the same period in 2016.

As of September 30, 2017, we determined that our goodwill was impaired and a non-cash goodwill impairment charge of $26.6 million was recorded during the quarter, and was classified as a component of operating expenses. The non-cash charge resulted from our goodwill assessment based on our market capitalization plus an implied control premium relative to the carrying value of our net assets. The non-cash charge has no effect on our current cash balance or operating cash flows.

Net loss attributed to common stockholders for the three- and nine-months ended September 30, 2017 was $31.9 million and $39.7 million, respectively. The increase in net loss is primarily due to a non-cash goodwill impairment charge of $26.6 million. Excluding the non-cash goodwill impairment charge, net loss attributed to common stockholders for the three- and nine-months ended September 30, 2017 was $5.3 million and $13.1 million, respectively, compared with $4.9 million and $8.3 million in the same periods in 2016.

Net loss per share attributed to common stockholders for the three- and nine-months ended September 30, 2017, was $2.05 and $3.43, respectively. Excluding the preliminary non-cash goodwill impairment charge, net loss per share attributed to common stockholders for the three- and nine-months ended September 30, 2017 was $0.34 and $1.13, respectively, compared with $0.71 and $1.20 in the same periods of 2016.

At September 30, 2017, the Company had cash and cash equivalents of approximately $17.1 million.

Non-GAAP Measures

To supplement the Company’s unaudited financial statements presented in accordance with generally accepted accounting principles ("GAAP"), this press release includes a discussion of adjusted net loss attributed to common stockholders and adjusted net loss per share attributed to common stockholders, in each case adjusted for the loss due to a goodwill impairment charge. The Company believes that these non-GAAP measures, when taken into consideration with the corresponding GAAP financial measures, provide investors with meaningful comparisons of current results to prior period results by excluding items that the Company does not believe reflect its fundamental business performance. See the attached schedule for a reconciliation of net loss to adjusted net loss and loss per share to adjusted loss per share for the three and nine months ended September 30, 2017 and 2016.

Conference Call Details

Date: Friday, November 10
Time: 8:30am Eastern Time
Domestic: 877-718-5098
International: 719-325-4831
Conference ID: 5172794
Webcast: View Source

Replays will be available through November 24:
Domestic: 844-512-2921
International: 412-317-6671
Replay PIN: 5172794

On November 9, 2017 ArQule, Inc. (Nasdaq: ARQL) reported its financial results for the third quarter of 2017 (Press release, ArQule, NOV 9, 2017, View Source [SID1234521832]).

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For the quarter ended September 30, 2017, the Company reported a net loss of $6,666,000 or $0.09 per share, compared with a net loss of $5,817,000 or $0.08 per share, for the third quarter of 2016. For the nine-month period ended September 30, 2017, the Company reported a net loss of $21,443,000 or $0.30 per share, compared with a net loss of $15,898,000 or $0.23 per share, for the nine-month period ended September 30, 2016.

At September 30, 2017, the Company had a total of approximately $27,603,000 in cash, equivalents and marketable securities. In October and November 2017, the Company raised approximately $25 million in net proceeds from two equity offerings.

Key Highlights

Miransertib (ARQ 092), lead AKT inhibitor, has met its primary endpoint of determining a biologically active dose in a phase 1 trial for Proteus syndrome lead by the National Human Genome Research Institute (NHGRI) of the National Institutes of Health (NIH). The NIH presented preliminary data from the ongoing phase 1 clinical trial for Proteus syndrome at the Proteus Syndrome Foundation Family Conference in September 2017. In five of the six patients, a reduction of a least 50% of phospho-AKT levels was reported. This met the primary objective of the study. Most significantly the NIH observed disease modification in the cerebriform connective tissue nevus (CCTN) lesions which are considered one of the hallmarks of the disease.
Miransertib was granted by the U.S. Food and Drug Administration (FDA) Rare Pediatric Disease Designation. Under the FDA’s rare pediatric disease priority review voucher program, the sponsor may be eligible for a voucher that can be used to obtain a priority review for a subsequent human drug application.
Miransertib continues to dose in the phase 1/2 trial for Overgrowth Diseases driven by PI3K and AKT mutations and opened its first U.S. clinical trial site. This trial is part of the company’s continued progress towards expanding its rare disease strategy in Overgrowth Diseases.
ARQ 531, an orally bioavailable, potent and reversible BTK inhibitor, continues dosing as planned in a phase 1a/b trial. The trial is enrolling patients with B-cell malignancies, including B-cell lymphomas, chronic lymphocytic leukemia, and Waldenstrom’s macroglobulinemia, who are refractory to other therapeutic options, including ibrutinib. Up to 120 patients can be enrolled in the trial.
Derazantinib (ARQ 087), a pan-FGFR inhibitor, in a registrational trial in FGFR2 fusion positive second-line intrahepatic cholangiocarcinoma (iCCA) is recruiting with six active sites in the U.S. The trial is planned to enroll up to 100 iCCA patients and provides an opportunity for a conditional approval as part of a fast-to-market strategy and includes an interim analysis that will be performed after the first 40 patients have been enrolled and evaluated for response.
Company raised approximately $29 million in capital through a private placement of $15.7 million of common stock, a private placement of $9.5 million of convertible preferred stock and an additional $4 million through unrelated business development activities and other sources. Net proceeds will be used to advance ArQule’s proprietary pipeline and for general business purposes, including working capital.
"The ArQule clinical pipeline is the strongest it has ever been, and the most recent positive developments are the compelling clinical data in Proteus syndrome and the granting of Rare Pediatric Disease Designation for miransertib in this indication," said Paolo Pucci, Chief Executive Officer of ArQule. "We are now well capitalized to see our pipeline assets through major inflection points."

"Based on the preliminary results from the phase 1 NIH-sponsored Proteus syndrome trial, miransertib is the first drug to demonstrate activity and achieve clinical proof of concept in this indication," said Dr. Brian Schwartz, M.D., Head of Research and Development and Chief Medical Officer at ArQule. "We are thankful to the NIH for their work in identifying the mutation driving the disease, conducting the first clinical trial and ultimately identifying potential clinical endpoints. We plan to engage regulatory authorities to define a clinical path to registration in this indication. In parallel and consistent with the regulatory interactions we will continue to enroll in our ongoing phase 1/2 trial in Overgrowth Diseases driven by mutations in the PI3K or AKT pathway, including Proteus syndrome, and provide the drug under compassionate policy."

Revenues and Expenses

Revenues for the quarter ended September 30, 2017, were zero compared with revenues of $1,223,000 for the quarter ended September 30, 2016. Revenues in the nine-months ended September 30, 2017 were zero compared with revenues of $3,522,000 in the nine-months ended September 30, 2016. Revenue in the three and nine-month periods of 2016 is comprised of revenue from the Daiichi Sankyo tivantinib development agreement and the Kyowa Hakko Kirin exclusive license agreement. No further revenue is anticipated from these agreements.

Research and development expense in the third quarter of 2017 was $4,570,000, compared with $5,265,000 for the third quarter of 2016. Research and development expense decreased $0.7 million in the third quarter of 2017 primarily due to lower outsourced preclinical, clinical and product development costs.

Research and development expense in the nine-months ended September 30, 2017 was $14,747,000 compared with $13,800,000 in the nine-months ended September 30, 2016. The $0.9 million increase in research and development expense in the nine-months ended September 30, 2017 was primarily due to higher outsourced clinical and product development costs.

General and administrative expense was $1,762,000 in the third quarter of 2017 compared with $1,824,000 in the third quarter 2016.

General and administrative expense was $5,702,000 in the nine-months ended September 30, 2017 compared with $5,755,000 in the nine-months ended September 30, 2016.

2017 Financial Guidance

As a result of ArQule’s recent stock offerings and business development activities the company is updating 2017 guidance. For 2017, ArQule expects net use of cash to range between $25 and $27 million. Net loss is expected to range between $28 and $30 million, net loss per share is expected to range between $(0.38) and $(0.40) for the year. ArQule expects to end 2017 with between $47 and $49 million in cash and marketable securities.

Conference Call and Webcast

ArQule will hold its third quarter 2017 financial results call today, November 9, 2017 at 9:00 a.m. ET. The live webcast can be accessed in the "Investors & Media" section of our website, www.arqule.com, under "Events & Presentations." You may also listen to the call by dialing (877) 868-1831 within the U.S. or (914) 495-8595 outside the U.S. A replay will be available two hours after the completion of the call and can be accessed in the "Investor and Media" section of our website, www.arqule.com, under "Events & Presentations."

On November 9, 2017 ArQule, Inc. (Nasdaq: ARQL) reported its financial results for the third quarter of 2017 (Press release, ArQule, NOV 9, 2017, View Source [SID1234521832]).

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For the quarter ended September 30, 2017, the Company reported a net loss of $6,666,000 or $0.09 per share, compared with a net loss of $5,817,000 or $0.08 per share, for the third quarter of 2016. For the nine-month period ended September 30, 2017, the Company reported a net loss of $21,443,000 or $0.30 per share, compared with a net loss of $15,898,000 or $0.23 per share, for the nine-month period ended September 30, 2016.

At September 30, 2017, the Company had a total of approximately $27,603,000 in cash, equivalents and marketable securities. In October and November 2017, the Company raised approximately $25 million in net proceeds from two equity offerings.

Key Highlights

Miransertib (ARQ 092), lead AKT inhibitor, has met its primary endpoint of determining a biologically active dose in a phase 1 trial for Proteus syndrome lead by the National Human Genome Research Institute (NHGRI) of the National Institutes of Health (NIH). The NIH presented preliminary data from the ongoing phase 1 clinical trial for Proteus syndrome at the Proteus Syndrome Foundation Family Conference in September 2017. In five of the six patients, a reduction of a least 50% of phospho-AKT levels was reported. This met the primary objective of the study. Most significantly the NIH observed disease modification in the cerebriform connective tissue nevus (CCTN) lesions which are considered one of the hallmarks of the disease.
Miransertib was granted by the U.S. Food and Drug Administration (FDA) Rare Pediatric Disease Designation. Under the FDA’s rare pediatric disease priority review voucher program, the sponsor may be eligible for a voucher that can be used to obtain a priority review for a subsequent human drug application.
Miransertib continues to dose in the phase 1/2 trial for Overgrowth Diseases driven by PI3K and AKT mutations and opened its first U.S. clinical trial site. This trial is part of the company’s continued progress towards expanding its rare disease strategy in Overgrowth Diseases.
ARQ 531, an orally bioavailable, potent and reversible BTK inhibitor, continues dosing as planned in a phase 1a/b trial. The trial is enrolling patients with B-cell malignancies, including B-cell lymphomas, chronic lymphocytic leukemia, and Waldenstrom’s macroglobulinemia, who are refractory to other therapeutic options, including ibrutinib. Up to 120 patients can be enrolled in the trial.
Derazantinib (ARQ 087), a pan-FGFR inhibitor, in a registrational trial in FGFR2 fusion positive second-line intrahepatic cholangiocarcinoma (iCCA) is recruiting with six active sites in the U.S. The trial is planned to enroll up to 100 iCCA patients and provides an opportunity for a conditional approval as part of a fast-to-market strategy and includes an interim analysis that will be performed after the first 40 patients have been enrolled and evaluated for response.
Company raised approximately $29 million in capital through a private placement of $15.7 million of common stock, a private placement of $9.5 million of convertible preferred stock and an additional $4 million through unrelated business development activities and other sources. Net proceeds will be used to advance ArQule’s proprietary pipeline and for general business purposes, including working capital.
"The ArQule clinical pipeline is the strongest it has ever been, and the most recent positive developments are the compelling clinical data in Proteus syndrome and the granting of Rare Pediatric Disease Designation for miransertib in this indication," said Paolo Pucci, Chief Executive Officer of ArQule. "We are now well capitalized to see our pipeline assets through major inflection points."

"Based on the preliminary results from the phase 1 NIH-sponsored Proteus syndrome trial, miransertib is the first drug to demonstrate activity and achieve clinical proof of concept in this indication," said Dr. Brian Schwartz, M.D., Head of Research and Development and Chief Medical Officer at ArQule. "We are thankful to the NIH for their work in identifying the mutation driving the disease, conducting the first clinical trial and ultimately identifying potential clinical endpoints. We plan to engage regulatory authorities to define a clinical path to registration in this indication. In parallel and consistent with the regulatory interactions we will continue to enroll in our ongoing phase 1/2 trial in Overgrowth Diseases driven by mutations in the PI3K or AKT pathway, including Proteus syndrome, and provide the drug under compassionate policy."

Revenues and Expenses

Revenues for the quarter ended September 30, 2017, were zero compared with revenues of $1,223,000 for the quarter ended September 30, 2016. Revenues in the nine-months ended September 30, 2017 were zero compared with revenues of $3,522,000 in the nine-months ended September 30, 2016. Revenue in the three and nine-month periods of 2016 is comprised of revenue from the Daiichi Sankyo tivantinib development agreement and the Kyowa Hakko Kirin exclusive license agreement. No further revenue is anticipated from these agreements.

Research and development expense in the third quarter of 2017 was $4,570,000, compared with $5,265,000 for the third quarter of 2016. Research and development expense decreased $0.7 million in the third quarter of 2017 primarily due to lower outsourced preclinical, clinical and product development costs.

Research and development expense in the nine-months ended September 30, 2017 was $14,747,000 compared with $13,800,000 in the nine-months ended September 30, 2016. The $0.9 million increase in research and development expense in the nine-months ended September 30, 2017 was primarily due to higher outsourced clinical and product development costs.

General and administrative expense was $1,762,000 in the third quarter of 2017 compared with $1,824,000 in the third quarter 2016.

General and administrative expense was $5,702,000 in the nine-months ended September 30, 2017 compared with $5,755,000 in the nine-months ended September 30, 2016.

2017 Financial Guidance

As a result of ArQule’s recent stock offerings and business development activities the company is updating 2017 guidance. For 2017, ArQule expects net use of cash to range between $25 and $27 million. Net loss is expected to range between $28 and $30 million, net loss per share is expected to range between $(0.38) and $(0.40) for the year. ArQule expects to end 2017 with between $47 and $49 million in cash and marketable securities.

Conference Call and Webcast

ArQule will hold its third quarter 2017 financial results call today, November 9, 2017 at 9:00 a.m. ET. The live webcast can be accessed in the "Investors & Media" section of our website, www.arqule.com, under "Events & Presentations." You may also listen to the call by dialing (877) 868-1831 within the U.S. or (914) 495-8595 outside the U.S. A replay will be available two hours after the completion of the call and can be accessed in the "Investor and Media" section of our website, www.arqule.com, under "Events & Presentations."

On November 9, 2017 Northern Biologics Inc., a developer of first-in-class immuno-oncology products, reported that Philip Vickers, Ph.D., is joining the company as CEO and a member of the board. Stefan Larson, Ph.D., who served as Northern Biologics’ founding CEO since 2014, will remain on the company’s board (Press release, Northern Biologics, NOV 9, 2017, View Source [SID1234521915]).

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Dr. Vickers is a preeminent R&D leader with more than two decades of experience in the biotech and pharmaceutical industry. Most recently, he served as global head of R&D and a member of the Executive Committee for Shire during a period of great growth and multiple regulatory approvals for the company. Under Dr. Vickers’ tenure the clinical development pipeline grew to approximately 40 programs.

Prior to joining Shire, Dr. Vickers held a range of R&D positions of increasing responsibility at Merck & Co. Inc., Pfizer Inc., Boehringer Ingelheim and Resolvyx Pharmaceuticals Inc. Dr. Vickers holds a Ph.D. in biochemistry from the University of Toronto.

"We feel very fortunate to have attracted someone of Phil’s reputation and caliber as the new leader of Northern Biologics. He brings critical experience and a track record in drug development to take Northern Biologics into its next phase of growth," said Brad Bolzon, Ph.D., chairman of Northern Biologics and Versant Ventures.

"I am very excited to lead Northern Biologics at a time that we are going through the critical stage of transitioning programs from research into clinical development," said Dr. Vickers. "Our lead antibody against LIF and our portfolio of novel therapeutic candidates have potential to impact areas of oncology where there is a significant unmet medical need."

Early next year, Northern Biologics will begin clinical testing of its lead immuno-oncology asset, MSC-1, in a range of cancers, working with world-leading cancer institutes in Canada, Europe and the U.S. MSC-1 is a humanized antibody against a soluble cytokine called LIF (see "About LIF" below) with the desired effects of blocking immunosuppression and inhibiting the self-renewal of cancer stem cells. In addition, the company’s pipeline includes several antibodies acting on other relevant oncology targets, including those within the TIGIT and the TIM-3 pathways.

"I would like to thank Stefan for guiding Northern through its launch phase and for setting the company on its current path to success," said Dr. Bolzon. "We are very pleased that Stefan is returning to Versant as a Venture Partner with responsibility for leading new investments within Ontario and the broader region of Eastern Canada."

About LIF

LIF, or leukemia inhibitory factor, is an exciting emerging target in the immuno-oncology space. Northern Co-Founder Joan Seoane first elucidated a role for the cytokine in cancer in a seminal 2009 publication in Cancer Cell. Since that time, several independent labs have verified and published the role of LIF in many cancers. For example, as part of the recent mounting evidence, researchers reported this fall that high levels of LIF occur in pancreatic tumors. Reports on several other LIF findings, including the elucidation of the MSC-1 binding site, are expected within the next few months.