On November 6, 2018 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported financial results for the third quarter of 2018 and recent operational progress (Press release, Atara Biotherapeutics, NOV 6, 2018, View Source [SID1234530798]).

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"We made important progress in the third quarter advancing our off-the-shelf, allogeneic T-cell immunotherapy pipeline," said Isaac Ciechanover, M.D., Chief Executive Officer and President of Atara Biotherapeutics. "We recently announced a strategic collaboration with Moffitt Cancer Center to expand our next-generation CAR T immunotherapy pipeline and initiated a Phase 1/2 clinical study of tab-cel in combination with Merck’s KEYTRUDA for patients with EBV-associated nasopharyngeal carcinoma. This is an exciting period for Atara and we look forward to updating you on additional pipeline results at the ASH (Free ASH Whitepaper) and ESMO (Free ESMO Whitepaper) IO scientific congresses in December."

Atara continues to advance its tab-cel (tabelecleucel) Phase 3 studies for patients with Epstein-Barr virus associated post-transplant lymphoproliferative disorder (EBV+ PTLD) and anticipates initial tab‑cel Phase 3 results in the first half of 2019. The Company is in ongoing discussions with the European Medicines Agency (EMA) and U.S. Food & Drug Administration (FDA) regarding the development and regulatory paths for tab‑cel based on its experience conducting the Phase 3 studies in patients with this life-threatening condition. The Company plans to share initial Phase 3 clinical results as well as observed EBV+ PTLD incidence with these agencies. The outcomes of both regulatory discussions are expected in the first half of 2019, and Atara now plans to submit a tab‑cel EU conditional marketing authorization (CMA) application in the second half of 2019.

Atara continues to build its pipeline and operational capabilities as well as prepare for the launch of its first commercial product. Initial results from the off-the-shelf, allogeneic ATA188 multiple sclerosis program are anticipated in the first half of 2019. In addition, the Company is rapidly advancing its next-generation chimeric antigen receptor T-cell (CAR T) pipeline across multiple therapeutic areas and expects to highlight results at upcoming events.

Recent Highlights and Anticipated Upcoming Milestones

Tab-cel (tabelecleucel)

Two Phase 3 clinical studies are ongoing (MATCH and ALLELE) to evaluate tab-cel (tabelecleucel) for patients with EBV+ PTLD who have failed rituximab following hematopoietic cell transplant (HCT) or solid organ transplant (SOT).
– Expanded MATCH and ALLELE study sites with 26 locations available for enrollment in the United States and Australia with additional sites expected to open in the United States and other geographies.

Initiated a Phase 1/2 clinical study of tab-cel in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA (pembrolizumab), in patients with platinum-resistant or recurrent EBV-associated nasopharyngeal carcinoma (NPC).

Scheduled to present new tab-cel efficacy and safety results in patients with EBV-associated leiomyosarcoma (EBV+ LMS) solid tumors at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress in December 2018.
60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting

Announced eight abstracts highlighting robust off-the-shelf, allogeneic T-cell immunotherapy pipeline and next-generation CAR T technologies to be presented at the 60th ASH (Free ASH Whitepaper) Annual Meeting in December 2018.
– Moffitt Cancer Center collaborators to present next-generation CAR T technology that increases T cell persistence and decreases exhaustion.
– Memorial Sloan Kettering (MSK) collaborators to present tab‑cel Phase 2 clinical results for patients with EBV+ PTLD involving the central nervous system (CNS).
– Current PTLD patient health outcomes and treatment patterns are described in additional ASH (Free ASH Whitepaper) abstracts.
Next-Generation CAR T Development Pipeline

Announced a strategic collaboration with Moffitt Cancer Center to develop multi-targeted CAR T immunotherapies for patients with AML and B cell malignancies.
– Along with prior CAR T collaboration with MSK, furthers Atara’s strategy to develop next‑generation CAR T immunotherapies across multiple therapeutic areas and leverage the Company’s off-the-shelf, allogeneic T-cell immunotherapy platform.
– Research supporting the novel CAR T co-stimulatory domain findings were recently published in the September 2018 issue of the Journal of Clinical Investigation.
– CAR T preclinical activities ongoing, with initial IND expected Q4 2019 to Q1 2020.

Hosting CAR T Breakfast Teach-In on November 29, 2018 in New York, NY focused on Atara’s next-generation CAR T immunotherapy pipeline for patients with hematologic and solid tumors, autoimmune and infectious diseases as well as off-the-shelf, allogeneic CAR T development using EBV-specific T cell platform.
– Featured experts: Michel Sadelain, M.D., Ph.D., MSK and Marco Davila, M.D., Ph.D., Moffitt Cancer Center.
ATA188 & ATA190 for Multiple Sclerosis (MS)

A Phase 1 clinical study to evaluate off-the-shelf, allogeneic ATA188 in patients with progressive MS is underway across clinical sites in the United States and Australia.
– Initial results from the ongoing study are expected in the first half of 2019.

Plan to initiate a randomized autologous ATA190 study in progressive MS patients in 2019.
Other Pipeline

Recent positive published results support Atara’s continued development of ATA621, targeting both JC and BK viruses for patients with progressive multifocal leukoencephalopathy (PML). The Company is currently conducting IND enabling manufacturing process development for this program.
Corporate

Strengthened the Company’s Board of Directors with the appointment of Roy Baynes, M.D., Ph.D. Dr. Baynes currently serves as Senior Vice President Global Clinical Development and Chief Medical Officer at Merck Research Laboratories.

Additional appointments include the promotion of Manher (AJ) Joshi, M.D., to Chief Medical Officer, the appointment of Renu Vaish as Atara’s Senior Vice President, Global Regulatory Affairs, as well as Jose Vidal’s appointment as Atara’s Senior Vice President, Head of GMP Quality and Process Sciences.

Continued to increase manufacturing activities at Atara T Cell Operations & Manufacturing (ATOM) facility with completion of licensure to support clinical production expected in 2019.
Third Quarter 2018 Financial Results

Cash, cash equivalents and short-term investments as of September 30, 2018 totaled $364.5 million, which the Company believes will fund planned operations to mid-2020.
The Company reported net losses of $58.4 million, or $1.29 per share, for the third quarter of 2018, as compared to $31.1 million, or $1.02 per share, for the same period in 2017.
In the third quarters of 2018 and 2017, total operating expenses of $60.2 million and $31.7 million included non-cash expenses of $10.4 million and $6.3 million, respectively.
Research and development expenses were $43.4 million for the third quarter of 2018, as compared to $20.6 million for the same period in 2017. The increase in the third quarter of 2018 was due to costs associated with the Company’s continuing expansion of research and development activities, including:
– clinical trial, manufacturing and outside service costs related to the two Phase 3 clinical trials of tab-cel in patients with EBV+ PTLD and the Phase 1 clinical trial of allogeneic ATA188 in patients with MS, and
– higher employee-related and overhead costs from increased headcount and operations.
Research and development expenses include $4.7 million and $2.1 million of non-cash stock-based compensation expenses in the third quarters of 2018 and 2017, respectively.
General and administrative expenses were $16.9 million for the third quarter of 2018, as compared to $11.1 million for the same period in 2017. The increase in the third quarter of 2018 was primarily due to increases in professional services costs and employee-related costs from increased headcount to support the Company’s expanding operations. General and administrative expenses include $4.6 million and $3.9 million of non-cash stock-based compensation expenses in the third quarters of 2018 and 2017, respectively.

On November 6, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) reported that the following abstracts have been published and are now available on the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference 2018 website (Press release, NewLink Genetics, NOV 6, 2018, View Source [SID1234530845]).

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Abstracts for poster presentation at the SITC (Free SITC Whitepaper) Annual Meeting, November 7-11, 2018

Abstract 11213: A phase 1a clinical trial of NLG802, a prodrug of indoximod with enhanced pharmacokinetic properties, Rixe, O., et al. (Poster #P331). Author will be present Friday, November 9th, 12:45-2:15 PM and 6:30-8:00 PM.
Abstract 10294: The immunogenomic impact of indoximod on the tumor microenvironment of melanoma patients, Yu, J., et al. (Poster #P142). Author will be present Saturday, November 10th, 12:20-1:50 PM and 7:00-8:30 PM.
Abstract 10304: Effects of indoximod plus gemcitabine/nab-paclitaxel on tumor microenvironment of patients with metastatic pancreatic cancer, Yu, J., et al. (Poster #P706). Author will be present Saturday, November 10th, 12:20-1:50 PM and 7:00-8:30 PM.
Posters will be accessible Friday, November 9th, and Saturday, November 10th, from 8 AM to 8 PM, in Exhibition Hall E of the Walter E. Washington Convention Center, Washington, D.C.

On November 6, 2018 Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL), reported financial results for the third quarter ended September 30, 2018, and also provided an update on the commercial launch of TAVALISSE for treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment and its clinical development pipeline (Press release, Rigel, NOV 6, 2018, View Source [SID1234530861]).

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Recent Highlights

·Net product sales of $4.9 million for TAVALISSE during the third quarter

·On October 29, entered into an exclusive license and supply agreement with Kissei Pharmaceutical Co., Ltd. (Kissei) for development and marketing rights to fostamatinib in Asia; Rigel to receive upfront cash payment of $33 million, with the potential for up to an additional $147 million in milestone payments and product transfer price payments based on tiered net sales

· On October 4, the European Medicines Agency (EMA) validated the company’s Marketing Authorization Application (MAA) for fostamatinib1 in adult chronic ITP, initiating the review process

· Phase 3 trial design for fostamatinib1 investigational candidate in autoimmune hemolytic anemia (AIHA) to be submitted to U.S. Food and Drug Administration (FDA) in early November

"We continue to advance our corporate strategy with solid execution across all business areas. The success of our TAVALISSE commercial launch in the United States, our collaboration with Kissei in Asia, and our MAA validation highlight the expanding capabilities of our organization," said Raul Rodriguez, president and CEO of Rigel. "In parallel, our clinical development plans continue to increase the potential of our pipeline. For our investigational agents, we plan to initiate our Phase 3 study for fostamatinib in autoimmune hemolytic anemia in the first half of 2019 and we continue to explore potential drug development opportunities including for our IRAK1/4 inhibitor, R835."

Financial Update

For the third quarter of 2018, Rigel reported a net loss of $23.8 million, or $0.14 per share, compared to a net loss of $17.7 million, or $0.14 per share, in the same period of 2017.

For the third quarter of 2018, Rigel reported net product sales from TAVALISSE of $4.9 million. Rigel recognizes revenue using the sell-in methodology when products are delivered to its distributors. There were no product sales in the third quarter of 2017.

There were no contract revenues from collaborations in the third quarter of 2018. Contract revenues from collaborations of $900,000 in the third quarter of 2017 were related to a payment received from a license agreement with a third party.

Rigel reported total costs and expenses of $29.2 million in the third quarter of 2018, compared to $18.8 million for the same period in 2017. The increase in costs and expenses was primarily due to the increases in personnel costs as Rigel expanded its customer-facing team, third party costs to support Rigel’s ongoing commercial efforts for TAVALISSE in chronic ITP, as well as stock-based compensation expense related to certain performance-based stock options.

For the nine months ended September 30, 2018, Rigel reported net product sales from TAVALISSE of $6.7 million. There were no product sales for the nine months ended September 30, 2017. For the nine months ended September 30, 2018, Rigel reported a net loss of $73.7 million, or $0.47 per share, compared to a net loss of $52.1 million, or $0.43 per share, for the same period of 2017.

As of September 30, 2018, Rigel had cash, cash equivalents and short-term investments of $115.6 million, compared to $115.8 million as of December 31, 2017. With the $33.0 million upfront payment Rigel will receive under its collaboration agreement with Kissei, as discussed below, Rigel expects that its cash, cash equivalents and short-term investments will be sufficient to support its current and projected funding requirements, including the on-going commercial launch of TAVALISSE for chronic ITP in the U.S., into the first quarter of 2020.

Business Update

Since commercial launch in May 2018, demand for TAVALISSE in adult patients with previous treatment failure in cITP continues to grow, with broad usage seen in steroid refractory patients. TAVALISSE has been utilized by a broad base of prescribers and community physicians, and the payor response has been positive with an approval rate of 85-90%.

Outside of the U.S., the company continues to further its global commercialization strategy. Rigel has entered an exclusive license and supply agreement with Kissei for the development and commercialization of fostamatinib in all indications in Japan. The agreement also provides Kissei with rights to fostamatinib in China, Taiwan, and the Republic of Korea. In exchange, Rigel will receive an upfront cash payment of $33 million with the potential for up to an additional $147 million in development and commercial milestone payments. The company will also receive product transfer price payments in the mid to upper twenty percent range based on tiered net sales for exclusive supply of fostamatinib.

In the EU, which is the second largest market for adult chronic ITP, the EMA validated the MAA for fostamatinib1 in the indication. The review process was initiated in October and the company anticipates an opinion from the Committee on Human Medicinal Products (CHMP) of the EMA by the fourth quarter of 2019.

Rigel continues to progress with its expansion plans for fostamatinib in other indications1 and will submit its Phase 3 trial design for the treatment of warm AIHA (wAIHA) to the FDA in early November. The trial, designed in consultation with the FDA, is a placebo-controlled study of approximately 80 patients with primary or secondary wAIHA who have failed at least one prior treatment. The primary endpoint will be a durable hemoglobin response by week 24, defined as Hgb > 10 g/dL and > 2 g/dL

greater than baseline and durability of response, with the response not being attributed to rescue therapy. Enrollment is expected to begin in the first half of 2019.

About ITP
In patients with ITP, the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPOs) and splenectomy. However, not all patients are adequately treated with existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About AIHA
AIHA is a rare, serious blood disorder in which the immune system produces antibodies that result in the destruction of the body’s own red blood cells. AIHA affects approximately 40,000 adult patients in the U.S. and can be a severe, debilitating disease. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients.

About R8351

The investigational candidate, R835, is an orally available, potent and selective inhibitor of IRAK1 and IRAK4 that has been shown preclinically to block inflammatory cytokine production in response to toll-like receptor (TLR) and the interleukin-1 (IL-1R) family receptor signaling. TLRs and IL-1Rs play a critical role in the innate immune response and dysregulation of these pathways can lead to a variety of inflammatory conditions. R835 is active in multiple rodent models of inflammatory disease including psoriasis, arthritis, lupus, multiple sclerosis and gout.

Conference Call and Webcast with Slides Today at 5:00PM Eastern Time
Rigel will hold a live conference call and webcast today at 5:00pm Eastern Time (2:00pm Pacific Time).

Participants can access the live conference call by dialing 855-892-1489 (domestic) or 720-634-2939 (international) and using the Conference ID number 1398326. The webcast, with slide presentation, can be accessed from Rigel’s website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.

About TAVALISSE
Indication
TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Important Safety Information
Warnings and Precautions

· Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.

· Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.

· Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (>Grade 3), interrupt, reduce dose or discontinue TAVALISSE.

· Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.

· TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.

Drug Interactions

· Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.

· It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.

· Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.

· Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.

Adverse Reactions

· Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).

· Common adverse reactions (>5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.

Please see www.TAVALISSE.com for full Prescribing Information.
t side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

TAVALISSE and RIGEL ONECARE are trademarks of Rigel Pharmaceuticals, Inc.

On November 6, 2018 Immune Design (Nasdaq: IMDZ), an immunotherapy company focused on next-generation therapies in oncology, reported financial results and a corporate update for the third quarter ended September 30, 2018 (Press release, Immune Design, NOV 6, 2018, View Source [SID1234530878]).

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"Given the promising data to date with G100, our intratumoral TLR4 cancer therapy, we are aggressively advancing an expanded clinical development plan for this proprietary agent," said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer of Immune Design. "While preserving the option to develop our other approaches in the future, we believe that G100’s unique mechanism of action in B cell malignancies warrants our near-term focus. Its single agent and combination activity coupled with a preferable safety profile are differentiating features that we believe better position us for clinical success. We look forward to sharing data as they mature later this year and over the next 12-18 months."

Corporate Highlights

•
In October, the company announced prioritization of resources to support expanded clinical development of G100.
◦
Initial focus will be in combination with pembrolizumab in relapsed follicular lymphoma (FL) patients who have received three prior lines of systemic therapy.
▪
Pursuant to discussions with the FDA, these patients may represent an unmet medical need, which may allow for a single arm study and potential for accelerated approval path.
▪
In an open label setting scheduled to begin in the first quarter of 2019, the plan is to evaluate:
•
clinical activity based on Objective Response Rate (ORR) and Duration of Response; and
•
patients by "TLR4HIGH" expression, an emerging biomarker that may provide the opportunity to pre-select patients with a higher likelihood to respond to G100.
◦
In addition, the company:
▪
plans to evaluate G100 in earlier lines of lymphoma in combination with rituximab; and
▪
is evaluating the potential development of G100 in other indolent lymphomas, as well as aggressive lymphomas and solid tumors.

•
Upcoming Data Presentations
◦
As announced earlier today, G100 will be featured in three presentations at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting, November 9 and 10.
▪
"Higher dose single-agent intratumoral G100 (a TLR4 agonist) results in increased biomarker activity and improved clinical outcomes in patients with follicular lymphoma"
•
A new cohort of 18 follicular lymphoma patients who received 20ug of G100 with low-dose radiation showed increased biomarker activity and improved clinical outcomes in comparison to the 10ug dose (n=16), without the use of an anti-PD-1 antibody.

•
Patients receiving the 20ug dose showed a positive trend of more rapid and deeper abscopal responses than those receiving 10ug.
•
Patients receiving 20ug showed improved responses in the TLR4HIGH subpopulation:
◦
Patients receiving 20ug had a 60% ORR (6/10) as compared to 29% ORR (2/7).
◦
Approximately 60% of the patients in both groups tested positive for baseline
TLR4HIGH >50% TLR4 expression prior to G100 treatment.
▪
"Synergistic anti-tumor effects of TLR4 agonist G100 and anti-OX40 antibody"
▪
"The TLR4 agonist G100 enhances the efficacy of adoptive T-cell therapy"
◦
G100 will also be featured at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on December 2, 6-8 pm, in a presentation titled: "Long Term Follow-up of a Phase 2 Study Examining Intratumoral G100 Alone and in Combination with Pembrolizumab in Patients with Follicular Lymphoma."
▪
Follow up of the patient data presented at ASH (Free ASH Whitepaper) 2017 (n=26) from a randomized study comparing G100 with low-dose radiation +/- Keytruda (pembrolizumab).
▪
Responses are durable with a trend towards longer progression free survival (PFS) on the arm with pembrolizumab (11.1 months) vs. the arm without (7.4 months).

•
Together, Immune Design believes these new clinical and preclinical data:
◦
Support using the higher, 20ug dose of G100 in further development;
◦
Provide additional evidence of G100’s clinical activity; and
◦
Support the further development of G100 as a single agent and in combination with other therapies, initially in B cell malignancies.

Financial Results

Third Quarter

•
Immune Design ended the third quarter of 2018 with $107.5 million in cash and cash equivalents, short-term investments, and other receivables compared to $144.2 million as of December 31, 2017.
•
Net loss and net loss per share for the third quarter of 2018 were $14.0 million and $0.29, respectively, compared to $13.4 million and $0.52, respectively, for the third quarter of 2017.
•
Revenue did not materially differ over the comparative periods. Revenue for the third quarter of 2018 was $0.5 million and was primarily attributable to $0.2 million in collaboration revenue associated with the Sanofi G103 HSV2 vaccine collaboration and $0.2 million in product sales to collaboration partners and other third parties. Revenue for the third quarter of 2017 was $0.5 million and was primarily attributable to collaboration revenue associated with the Sanofi G103 collaboration.
•
Research and development expenses for the third quarter of 2018 were $11.2 million, compared to $10.2 million for the same period in 2017. The $1.0 million increase was primarily attributable to milestone payments of $1.7 million due to third parties as a result of the commencement of our SYNOVATE study, which was offset by a decrease in contract manufacturing services and personnel-related expenses.
•
General and administrative expenses did not materially differ over the comparative periods. For the three months ended September 30, 2018, general and administrative expenses were $3.8 million compared to $3.9 million for the same period in 2017.

Year-to-Date

•
Net cash used in operations for the nine months ended September 30, 2018 was $40.3 million.

•
Net loss and net loss per share for the nine months ended September 30, 2018 were $41.2 million and $0.85, respectively, compared to $39.9 million and $1.56, respectively, for the same period in 2017.
•
Revenue for the nine months ended September 30, 2018 was $1.7 million and was primarily due to $1.1 million in collaboration revenue associated with the Sanofi G103 collaboration and $0.6 million in product sales to our collaboration partners and other third parties. Revenue for the nine months ended September 30, 2017 was $6.7 million and was primarily attributable to $6.4 million in collaboration revenue associated with the Sanofi G103 collaboration and $0.3 million in product sales to collaboration partners other third parties.
•
Research and development expenses for the nine months ended September 30, 2018 were $32.5 million compared to $35.1 million for the same period in 2017. The $2.6 million decrease was primarily due to a decrease of $4.9 million in contract manufacturing costs and a slight decrease of $0.3 million in clinical trial costs. This decrease was offset by an increase of $0.9 million in personnel-related expenses and $1.7 million of milestone payments.
•
General and administrative expenses did not materially differ over the comparative periods. For the nine months ended September 30, 2018, general and administrative expenses were $11.8 million compared to $11.9 million for the same period in 2017.

Cash Guidance

Based on current expectations, Immune Design expects to have cash to fund operations into 2021.

Conference Call Information

Immune Design will host a conference call and live audio webcast this afternoon at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time to discuss third quarter 2018 financial results and provide a corporate update.

The live call may be accessed by dialing 844-266-9538 for domestic callers and 216-562-0391 for international callers. A live webcast of the call will be available online from the investor relations section of the Immune Design website at View Source and will be archived there for 30 days. A telephone replay of the call will be available for five days by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference code 1359112.

On November 6, 2018 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the following presentations by Company management at upcoming investor conferences will be webcast (Press release, ImmunoGen, NOV 6, 2018, View Source [SID1234530940]):

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Jefferies London Healthcare Conference
November 14, 2018 at 9:40 am ET/2:40 pm GMT
Evercore ISI HealthConX
November 27, 2018 at 8:45 am ET
30th Annual Piper Jaffray Healthcare Conference
November 28, 2018 at 11:30 am ET
A webcast of each presentation will be accessible live through the "Investors" section of the Company’s website, www.immunogen.com; a replay will be available in the same location for approximately two weeks.