On November 1, 2018 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that abstracts highlighting two of the Company’s experimental ADC therapies, IMGN779 and IMGN632, have been accepted for presentations at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held December 1-4 in San Diego, California (Press release, ImmunoGen, NOV 1, 2018, View Source [SID1234530514]).

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Both IMGN779 and IMGN632 use ImmunoGen’s novel indolino-benzodiazepine payloads called IGNs, which alkylate DNA without crosslinking. IGNs have been designed to have high potency against acute myeloid leukemia (AML) blasts, while demonstrating less toxicity to normal marrow progenitors than other DNA-targeting payloads.1 IMGN779 is a next-generation anti-CD33 ADC for the treatment of AML, currently in Phase 1 testing. IMGN632 is a CD123-targeting ADC for hematological malignancies, including AML and blastic plasmacytoid dendritic cell neoplasm (BPDCN), and is also in Phase 1 testing.

In an oral presentation, safety and anti-leukemia activity findings from the ongoing dose escalation study of IMGN779 in patients with relapsed or refractory AML will be reported. In a separate oral presentation, initial safety and anti-leukemia activity findings from the dose escalation stage of the first-in-human trial of IMGN632 will be reported. Preclinical data related to IMGN632 will also be presented in poster sessions.

ORAL PRESENTATIONS

Title (Abstract #26): "Maturing Clinical Profile of IMGN779, a Next-Generation CD33-Targeting Antibody-Drug Conjugate, in Patients with Relapsed or Refractory Acute Myeloid Leukemia"
Oral session 613: Saturday, December 1, 2018, 7:45am PST
Title (Abstract #27): "A Phase I, First-in-Human Study Evaluating the Safety and Preliminary Antileukemia Activity of IMGN632, a Novel CD123-Targeting Antibody-Drug Conjugate, in Patients with Relapsed/Refractory Acute Myeloid Leukemia and Other CD123-Positive Hematologic Malignancies"
Oral session 613: Saturday, December 1, 2018, 8:00am PST.
POSTER SESSIONS

Title (Abstract #2647): "Synergistic anti-leukemia activity of PARP inhibition combined with IMGN632, an anti-CD123 antibody-drug conjugate in acute myeloid leukemia models"
Poster session 604: Sunday, December 2, 2018, 6:00-8:00pm PST
Title (Abstract #3956): "Pre-clinical efficacy of CD123-targeting antibody-drug conjugate IMGN632 in Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) models"
Poster session 605: Monday, December 3, 2018, 6:00-8:00pm PST
Additional information can be found at www.hematology.org, including abstracts.

ABOUT IGNs

Indolino-benzodiazepine cancer-killing agents, or IGNs, are a new class of cancer-killing agent developed by ImmunoGen for use in ADCs. These ultra-potent, DNA-acting IGNs alkylate DNA without crosslinking, which preclinically has resulted in potent anti-leukemia activity with relative sparing of normal hematopoietic progenitor cells.

ABOUT IMGN779

IMGN779 is a novel ADC that combines a high-affinity, humanized anti-CD33 antibody, a cleavable disulfide linker, and one of ImmunoGen’s novel indolino-benzodiazepine payloads, called IGNs, which alkylate DNA without crosslinking, resulting in potent preclinical anti-leukemia activity with relative sparing of normal hematopoietic progenitor cells. IMGN779 is in Phase 1 clinical testing for the treatment of AML.

ABOUT IMGN632

IMGN632 is a novel, anti-CD123 antibody-drug conjugate that is a potential treatment for AML, BPDCN, and other CD123-positive malignancies. IMGN632 uses a novel humanized anti-CD123 antibody coupled via a peptide linker to a unique DNA-alkylating IGN payload. In preclinical models, IMGN632 has exhibited potent antitumor activity with a wide therapeutic index in AML, BPDCN, and acute lymphoblastic leukemia (ALL). IMGN632 is in Phase 1 clinical testing for the treatment of AML and BPDCN.

On November 1, 2018 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported it will host a teleconference and webcast with management to discuss the third quarter 2018 financial results, provide an update on the company’s business, and discuss expectations for the future on Thursday, November 8, 2018 at 4:30 p.m. Eastern/1:30 p.m. Pacific (Press release, Spectrum Pharmaceuticals, NOV 1, 2018, View Source [SID1234530530]).

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Conference Call

Thursday, November 8, 2018 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic: (877) 837-3910, Conference ID# 3075918
International: (973) 796-5077, Conference ID# 3075918
For interested individuals unable to join the call, a replay will be available from November 8, 2018 @ 7:30 p.m. ET/4:30 p.m. PT through November 15, 2018 until 11:59 p.m. ET/8:59 p.m. PT.

Domestic Replay: (855) 859-2056, Conference ID# 3075918
International Replay: (404) 537-3406, Conference ID# 3075918
This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: View Source on November 8, 2018 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

On November 1, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) reported consolidated financial results for the third quarter ended September 30, 2018 (Press release, Pacira Pharmaceuticals, NOV 1, 2018, View Source;p=irol-newsArticle&ID=2374725 [SID1234530546]).

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"As evident from these financial results, EXPAREL continues to deliver impressive sales growth with physicians having great success delivering targeted, long-acting, opioid-free local or regional analgesia for postsurgical pain in a variety of procedures," said Dave Stack, chairman and chief executive officer of Pacira Pharmaceuticals. "Specifically we are seeing great enthusiasm around the use of EXPAREL as a brachial plexus nerve block and an increasing number of anesthesiologists incorporating EXPAREL into their suite of postsurgical pain solutions by expanding its use in newer regional anesthesia techniques, such as transverse abdominis, pectoralis and fascial iliaca plane blocks. In addition, our highly successful partnership with Johnson & Johnson remains a key growth driver as we integrate EXPAREL into multiple joint marketing programs, including a new initiative that will feature EXPAREL and TYLENOL as a platform for opioid-free postsurgical pain relief. Overall we are very pleased to be increasing our financial guidance for the second time this year."

"Looking forward we expect various initiatives to expand access to EXPAREL, particularly the assignment of new ambulatory care and dental reimbursement codes at the beginning of 2019, as well as increasing public and private payer recognition of the need for non-opioid pain relief following surgery."

Third Quarter 2018 Financial Results

EXPAREL net product sales were $82.2 million in the third quarter of 2018, a 23% increase over the $66.8 million reported for the third quarter of 2017.

Total operating expenses were $79.4 million in the third quarter of 2018, compared to $70.9 million in the third quarter of 2017.

GAAP net loss was $0.6 million, or $(0.02) per share (basic and diluted), in the third quarter of 2018, compared to a GAAP net loss of $7.6 million, or $(0.19) per share (basic and diluted), in the third quarter of 2017.

Non-GAAP net income was $12.8 million, or $0.31 per share (basic and diluted) in the third quarter of 2018, compared to non-GAAP net income of $4.4 million, or $0.11 per share (basic and diluted) in the third quarter of 2017.

Pacira ended the third quarter of 2018 with cash, cash equivalents and short-term investments ("cash") of $386.4 million.

Pacira had 41.0 million basic weighted average shares of common stock outstanding in the third quarter of 2018.

Pacira had 42.0 million diluted weighted average shares of common stock outstanding in the third quarter of 2018.
2018 Financial Guidance

Today, the company is increasing its full-year 2018 guidance for EXPAREL net product sales and improving its guidance for non-GAAP gross margins. The remainder of the company’s guidance remains unchanged from the ranges previously provided in August 2018. A summary of Pacira’s full-year 2018 financial guidance is outlined below.

EXPAREL net product sales of $325 million to $330 million.

Non-GAAP gross margins of 74% to 75%.

Non-GAAP research and development (R&D) expense of $50 million to $60 million.

Non-GAAP selling, general and administrative (SG&A) expense of $150 million to $160 million.

Stock-based compensation of $30 million to $35 million.
See "Non-GAAP Financial Information" and "Reconciliations of GAAP to Non-GAAP 2018 Financial Guidance" below.

Today’s Conference Call and Webcast Reminder

The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Thursday, November 1, at 8:30 a.m. ET. To participate in the conference call, dial 1-877-845-0779 and provide the passcode 1988603. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 1988603. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

Non-GAAP Financial Information

This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP net income (loss), non-GAAP net income (loss) per share, non-GAAP cost of goods sold, non-GAAP gross margins, non-GAAP research and development (R&D) expense and non-GAAP selling, general and administrative (SG&A) expense, because such measures exclude milestone revenue, stock-based compensation, amortization of debt discount, loss on early extinguishment of debt, exit costs related to the discontinuation of DepoCyt(e) production and loss on an unexercised investment purchase option.

These measures supplement the company’s financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future cost of goods sold, gross margins, R&D expense and SG&A expense outlook for 2018 and to help make managerial decisions. In management’s opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the operating performance at Pacira and the company’s future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures, and a reconciliation of our GAAP to non-GAAP 2018 financial guidance for gross margins, R&D expense and SG&A expense.

On November 1, 2018 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing neoantigen cancer immunotherapies, reported its financial and operating results for the third quarter ended September 30, 2018 (Press release, Genocea Biosciences, NOV 1, 2018, View Source [SID1234530574]).

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"In the year since our strategic pivot, we have made significant progress by advancing our lead cancer vaccine candidate, GEN-009, into the clinic and using our ATLAS platform to identify and characterize the T cell responses cancer patients make to both tumor-associated antigens and neoantigens," said Chip Clark, president & CEO of Genocea. "We continue to believe that ATLAS, which lets patients’ own T cells identify the optimal antigens for their cancer immunotherapies, stands apart from peer approaches that instead rely on software to predict antigens. We believe that the next evidence for this will emerge from our upcoming presentations at SITC (Free SITC Whitepaper) and then from the first patient cohort in our Phase 1/2a clinical trial for GEN-009, from which we expect to report immunogenicity data in the first half of 2019."

Recent Milestones & Events
•
October 2018: Announced multiple presentations at the upcoming meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2018) taking place November 7-11, 2018 at the Walter E. Washington Convention Center in Washington, D.C. These posters further highlight the advantages of Genocea’s ATLAS platform over in silico methods in identifying both neoantigens for vaccine inclusion and "inhibitory" neoantigens for exclusion. Genocea believes that the "inhibitory" antigen findings may point to novel biological insights only available through ATLAS. The following posters will be presented simultaneously on Saturday, November 10 from 12:20 – 1:50 p.m. and 7:00 – 8:30 p.m. ET in Poster Hall E:
◦
Poster Number: P154
Title: Empiric profiling of neoantigen-specific T cell responses in NSCLC patients with ATLAS reveals unexpected neoantigen and inhibitory antigen profiles
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Poster Number: P166
Title: Ex vivo ATLAS-identified inhibitory neoantigens promote mouse melanoma tumor progression
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Poster Number: P174
Title: A phase 1/2a study to evaluate the safety, tolerability, immunogenicity, and anti-tumor activity of GEN-009 adjuvanted neoantigen vaccine in adult patients with selected solid tumors
•
October 2018: Strengthened its leadership team with the addition of Thomas Davis, M.D. as Chief Medical Officer and Derek Meisner, J.D., as General Counsel. Dr. Davis joins Genocea with 20+ years of academic

and industry experience in immuno-oncology and cancer drug development. Mr. Meisner brings broad legal expertise to Genocea as the company’s first General Counsel.

Third Quarter 2018 Financial Results
•
Cash Position: As of September 30, 2018, cash and cash equivalents were $34.5 million compared to $12.3 million, as of December 31, 2017.
•
Research and Development (R&D) Expenses: R&D expenses were $6.4 million for the quarter ended September 30, 2018, compared to $10.2 million for the same period in 2017. The decrease was due largely to reduced headcount-related costs, external development, clinical, and consulting costs.
•
General and Administrative (G&A) Expenses: G&A expenses were $4.1 million for the quarter ended September 30, 2018, compared to $3.8 million for the same period in 2017. The increase was primarily due to increases in professional services expenses, partially offset by decreases in consulting costs.
•
Net Loss: Net loss was $7.8 million for the quarter ended September 30, 2018, compared to a net loss of $16.9 million for quarter ended September 30, 2017.

Financial Guidance
Genocea expects that its existing cash and cash equivalents are sufficient to support its operating expenses and capital expenditure requirements into the fourth quarter of 2019.

Genocea continues to explore strategic alternatives for GEN-003, its Phase 3-ready investigational immunotherapy for the treatment of genital herpes.

Conference Call
Genocea will host a conference call and webcast today at 9:00 a.m. ET. The conference call may be accessed by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 9864055. A live webcast of the conference call will be available online from the investor relations section of the Company’s website at View Source A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

On November 1, 2018 Inflection Biosciences Ltd, a private company developing innovative therapeutics for cancer, reported that it has entered into a research collaboration with The University of Texas MD Anderson Cancer Center ("MD Anderson") (Press release, Inflection Biosciences, NOV 1, 2018, View Source [SID1234530655]). The collaboration aims to explore the effects of the company’s pipeline of potential cancer treatments, including its first-in-class, dual mechanism PIM/PI3K inhibitors, in head and neck cancer.

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The research will be carried out at the Department of Thoracic Head and Neck Medical Oncology, Division of Cancer Medicine, MD Anderson, by Professors Xiuning Le and Maura Gillison. Professor Gillison, a head and neck medical oncologist and molecular epidemiologist, was the first to make the association of human papillomavirus (HPV) in head and neck cancer. She is a leading expert on HPV and oral cancer. Her work also points to a crucial role for PIM and PI3K in the origin and development of certain head and neck cancers.

Dr Michael O’Neill, Director of Research and Development at Inflection Biosciences commented, "We are excited to announce this collaboration with MD Anderson. The team involved in this research are leaders in the field of head and neck cancer research and will enhance our understanding of the potential for our treatments in cancer patients."

About PIM and PI3K in head and neck cancer

Head and neck cancers are a difficult to treat group of cancers responsible for over 300,000 deaths worldwide each year. Although these are a heterogenous group of cancers, alterations in the function of the PI3K signalling pathway are routinely observed throughout the spectrum of head and neck cancers. Elevated PIM expression is associated with squamous cell carcinomas of the head and neck. High levels of PIM expression have also been found in nasopharyngeal cancer (NPC) cell lines.