On March 10, 2022 TG Therapeutics, Inc. (NASDAQ: TGTX), reported the U.S. Food and Drug Administration (FDA) has set a date of April 22, 2022 for the previously announced meeting of the Oncologic Drugs Advisory Committee (ODAC) in connection with its review of the Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and UKONIQ (umbralisib) (combination referred to as U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) (Press release, TG Therapeutics, MAR 10, 2022, View Source [SID1234609869]). Background material and the link to the online teleconference meeting room will be available at View Source

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The Company previously announced that the FDA extended the Prescription Drug User Fee Act (PDUFA) goal date to June 25, 2022 for the BLA/sNDA for U2 to treat CLL and SLL.

Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, "As noted on our recent year-end call, the team, as well as our external consultants, have been working hard to prepare and we look forward to sharing the data with everyone during the ODAC meeting."

ABOUT THE ODAC MEETING
In general, the Oncologic Drugs Advisory Committee (ODAC) reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes appropriate recommendations to the Commissioner of Food and Drugs. Although the FDA will consider the recommendation of the ODAC Committee, the final decision regarding the approval of a product is made solely by the FDA.

The FDA has notified the Company that potential questions and discussion topics for the ODAC include: the benefit-risk of the U2 combination in the treatment of CLL or SLL, and the benefit-risk of UKONIQ in relapsed/refractory marginal zone lymphoma (MZL) or follicular lymphoma (FL). In addition, as part of the benefit-risk analysis, the overall safety profile of the U2 regimen, including adverse events (serious and Grade 3-4), discontinuations due to adverse events, and dose modifications, is expected to be reviewed. The FDA’s concern giving rise to the ODAC meeting appears to stem from an early analysis of overall survival from the UNITY-CLL trial.

Overall survival was designated as a secondary efficacy outcome in the UNITY-CLL protocol but was not part of the primary analysis in accordance with the study’s statistical analysis plan agreed upon via a Special Protocol Assessment (SPA), and therefore, was not analyzed or included in the BLA/sNDA. Additionally, the study was not powered for overall survival. As part of the ongoing review of the BLA/sNDA, the FDA requested an early analysis of overall survival from the UNITY-CLL trial. As of September 2021, the cut-off date for the overall survival analysis requested by the FDA during their review, there was an imbalance in favor of the control arm (HR: 1.23) though this result was not statistically significant. However, when excluding deaths related to COVID-19, the two arms were approximately balanced (HR: 1.04) with again no statistically significant difference between the treatment groups with regard to overall survival. In February 2022, the Company submitted updated overall survival data with the same September 2021 cut-off date. FDA considered the updated OS data a substantial amendment and extended the PDUFA date for the BLA/sNDA to June 25, 2022. The Company will continue to evaluate this endpoint over time as more events are available and will continue to analyze how COVID-19 may be impacting the analysis.

The ODAC meeting is scheduled to take place on April 22, 2022.

ABOUT UNITY-CLL PHASE 3 TRIAL AND THE BLA/sNDA SUBMISSION
UNITY-CLL is a global, Phase 3, randomized, controlled clinical trial comparing the combination of ublituximab plus UKONIQ (umbralisib), or U2, to an active control arm of obinutuzumab plus chlorambucil in patients with both treatment-naïve and relapsed or refractory chronic lymphocytic leukemia (CLL). The trial randomized patients into four treatment arms: ublituximab single agent, UKONIQ single agent, ublituximab plus UKONIQ, and an active control arm of obinutuzumab plus chlorambucil. A prespecified interim analysis was conducted to assess the contribution of ublituximab and UKONIQ in the U2 combination arm and allowed for the termination of the single agent arms. Accordingly, the UNITY-CLL Phase 3 trial continued enrollment in a 1:1 ratio into the two combination arms: the investigational arm of U2 and the control arm of obinutuzumab plus chlorambucil. Approximately 420 subjects enrolled to the two combination arms and approximately 60% of patients were treatment-naïve and 40% were relapsed or refractory. The primary endpoint for this study was superior progression-free survival (PFS) for the U2 combination compared to the control arm. The trial met its primary endpoint, with U2 significantly prolonging independent review committee (IRC) assessed PFS vs. control (median 31.9 months vs 17.9 months; hazard ratio 0.546 (p<0.0001)) at a median follow-up of 36.7 months, and results were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2020. The UNITY-CLL Phase 3 trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).

The BLA/sNDA submissions of U2 to treat CLL were based on the results of the UNITY-CLL trial. The FDA previously granted Fast Track designation to the U2 combination for the treatment of adult patients with CLL and orphan drug designation for ublituximab in combination with UKONIQ for the treatment of CLL.

ABOUT CHRONIC LYMPHOCYTIC LEUKEMIA
Chronic lymphocytic leukemia (CLL) is the most common type of adult leukemia. It is estimated there will be more than 20,000 new cases of CLL diagnosed in the United States in 2020 and approximately 45,000 new cases globally in 2020.1,2 Although signs and symptoms of CLL may disappear for a period of time after initial treatment, the disease is considered incurable and many people will require additional treatment due to the return of malignant cells.

On March 10, 2022 BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, reported its financial results for the fourth quarter and full year ended December 31, 2021 and provided an update on key strategic initiatives (Press release, BioXcel Therapeutics, MAR 10, 2022, View Source [SID1234609868]).

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"2021 was marked by significant achievement across the business, most notably with the NDA submission for BXCL501, which concluded an unprecedented, less than three-year journey from first-in-human trials to regulatory submission," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. "As we near potential approval, we remain focused on executing our launch readiness plan. Matt Wiley, who recently joined as our Chief Commercial Officer, has, and will continue to play a pivotal role in developing our commercial and market access strategy and building out our field sales organization. In parallel, we continued to advance our ‘land and expand’ strategy by furthering our Alzheimer’s disease and MDD programs, both important components of our five-year vision to become the leading AI-enabled neuroscience Company."

Dr. Mehta added, "Our oncology franchise further progressed with encouraging composite response rates for BXCL701 in combination with KEYTRUDA for mCRPC patients with SCNC and adenocarcinoma phenotypes, both aggressive tumors with very few treatment options. We continue to develop BXCL701’s potential to convert cold tumors to hot as a novel systemic innate immune activator."

Company Highlights

Neuroscience Franchise

BXCL501 is an investigational, proprietary, orally dissolving, thin film formulation of the adrenergic receptor agonist dexmedetomidine for the treatment of agitation associated with neuropsychiatric disorders. BXCL501 has received U.S. Food & Drug Administration (FDA) Breakthrough Therapy designation for the acute treatment of agitation associated with dementia and FDA Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders I and Il, and dementia.

BXCL501 for the Acute Treatment of Agitation in Patients with Schizophrenia and Bipolar Disorders: The Company is gearing up to launch BXCL501 in the U.S. pending FDA approval by the April 5, 2022 PDUFA action date. This is a large addressable market, with over 7 million people in the U.S. diagnosed with schizophrenia or bipolar disorders1-3, totaling approximately 25 million annual agitation episodes.3

Data Published in Journal of the American Medical Association (JAMA) from SERENITY II Pivotal Phase 3 Trial Evaluating BXCL501 in Bipolar Disorders: Results demonstrate BXCL501 as a potential treatment for the millions of patients experiencing agitation, a difficult-to-manage symptom associated with many neuropsychiatric conditions.
Indication Expansion

BXCL501 for Acute Treatment of Agitation in Patients with Alzheimer’s Disease: Initiated pivotal Phase 3 program in Q4 2021 following alignment with FDA on key trial design features. Alzheimer’s disease is the most prevalent type of dementia in the U.S. and is expected to approximately double from 5.8 million patients in 2020 to 11.8 million patients by 2040.4

BXCL501 for Major Depressive Disorder (MDD): Submitted an Investigational New Drug (IND) application to evaluate BXCL501 as an adjunct treatment for MDD, the most common type of depression in the United States with approximately 27 million cases a year.5 There are over 300 million antidepressant prescriptions filled annually, with limitations of current treatment including slow onset of action and incomplete response.6
Geographic Expansion

International Growth: The Company expects to submit a Marketing Authorization Application to the European Medicines Agency (EMA) for BXCL501 in 1H 2022.
AI-driven Drug Discovery & Development

The Company continues its innovative approach to R&D by leveraging its proprietary artificial intelligence platform to expand its current neuroscience portfolio, including identification of the Company’s newest product candidate, BXCL502. The Company initiated formulation for this new product candidate for chronic treatment of agitation in dementia patients. BXCL502 is designed to be a potent and selective antagonist for a GPCR target affecting serotonergic signaling in the cerebral cortex.
BXCL501 Commercial Readiness Progress

Expanded Commercial Organization: Hired Chief Commercial Officer Matt Wiley to develop integrated commercial strategy for potential BXCL501 approval and beyond, and continue the buildout of the Company’s national sales force.

Medical Science Liaison and Medical Managed Care Teams Fully Deployed: Continued engagement with health care professionals (HCPs) and payers to provide key insights and support potential BXCL501 commercial launch, including planned participation at:
Academy of Managed Care Pharmacy annual meeting in March 2022
International Society of Pharmacoeconomics and Outcomes Research conference in May 2022
Immuno-Oncology Franchise

BXCL701 is an investigational, orally administered, systemic innate immune activator in development for treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors.

Metastatic Castration-Resistant Prostate Cancer (mCRPC) Program: Presented positive data from Phase 2 trial of BXCL701 in aggressive forms of prostate cancer at 2022 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium in February. The presentations showed that BXCL701 plus KEYTRUDA (pembrolizumab) demonstrated encouraging composite response rates in patients with either adenocarcinoma (21% response rate) or SCNC (33% response rate) phenotype, supporting further evaluation of BXCL701’s potential to extend checkpoint inhibitor therapy into cold tumor settings.

Solid Tumors Program (Checkpoint Naïve and Refractory): Additional efficacy data from MD Anderson-led open-label Phase 2 basket trial of BXCL701 and KEYTRUDA expected in 2H 2022.
Fourth Quarter and Full Year 2021 Financial Results

Research and Development Expenses: Research and development expenses were $12.5 million for the fourth quarter of 2021, compared to $11.4 million for the same period in 2020. The increased expenses were primarily attributable to increased headcount and related costs during the three-month period of 2021.

Research and development expenses were $52.7 million for the full year 2021, as compared to $58.0 million for the same period in 2020. The decrease for the year ended December 31, 2021 was primarily attributable to decreased clinical trial expenses related to BXCL501, partially offset by increased costs related to BXCL701 clinical trials.

General and Administrative Expenses: General and administrative expenses were $13.6 million for the fourth quarter of 2021, as compared to $9.7 million for the same period in 2020. The increase was primarily due to increased headcount and related costs, including higher stock-based compensation, increased marketing and commercial costs related to the potential launch of BXCL501 in the U.S., as well as increased legal and professional fees, and insurance costs.

General and administrative expenses were $54.2 million for the full year 2021, as compared to $24.3 million for the same period in 2020. The increase for the year ended December 31, 2021 was primarily attributable to increased headcount and associated costs, including non-cash stock-based compensation. The Company also incurred significant commercial costs in preparation for a potential U.S. launch of BXCL501.

Net Loss: BioXcel Therapeutics reported a net loss of $26.1 million for the fourth quarter of 2021, compared to a net loss of $21.1 million for the same period in 2020. For the full year, BioXcel reported a net loss of $106.9 million, compared to a net loss of $82.2 million for the same period in 2020.

As of December 31, 2021, cash and cash equivalents totaled approximately $233.0 million.

Conference Call

BioXcel Therapeutics will host a conference call and webcast March 10, 2022 at 8:30 a.m. ET, to discuss its fourth quarter and full year 2021 financial results and provide an update on recent operational highlights. To access the call, please dial 877-407-5795 (domestic) and 201-689-8722 (international). A live webcast of the call will be available on the Investors section of the BioXcel website, www.bioxceltherapeutics.com, and a replay of the call will be available through at least April 10, 2022.

BioXcel Therapeutics may use its website as a distribution channel of material information about the Company. Financial and other important information regarding the Company is routinely posted on and accessible through the Investors sections of its website at www.bioxceltherapeutics.com. In addition, you may automatically receive email alerts and other information about the Company when you enroll your email address by visiting the "Email Alerts" option under the News/Events menu of the Investors & Media section of its website.

On March 10, 2022 Leidos (NYSE: LDOS), a FORTUNE 500 science and technology company, reported that it will participate in the J.P. Morgan 2022 Industrials Conference in New York City (Press release, Leidos, MAR 10, 2022, View Source [SID1234609867]).

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Roger Krone, Chief Executive Officer, will be presenting Thursday, March 17, 2022 at 1:20 p.m. ET.

A live audio webcast of the event will be available on the Leidos Investor Relations website at View Source A replay of the webcast will be available following the presentation at the same link listed above for 30 days afterward.

On March 10, 2022 Primmune Therapeutics, a biotech company harnessing the power of the innate immune system to treat cancers and viral diseases, reported that Charles McDermott, President and Chief Executive Officer of Primmune, will present at the 32nd Annual Oppenheimer Healthcare Conference, which will be held virtually March 15 to 17 (Press release, Primmune Therapeutics, MAR 10, 2022, View Source [SID1234609866]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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32nd Annual Oppenheimer Healthcare Conference

Date: Tuesday, March 15
Time: 2:40 p.m. ET

More information about the conference can be found here.

On March 10, 2022 Genocea Biosciences, Inc. (Nasdaq: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported a business update for the fourth quarter ended December 31, 2021 (Press release, Genocea Biosciences, MAR 10, 2022, View Source [SID1234609865]).

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GEN-011 TiTAN trial update
Genocea is conducting the Phase I/2a TiTAN clinical trial for its lead program GEN-011, a neoantigen-targeted peripheral T cell (NPT) therapy candidate. GEN-011 is comprised only of CD8+ and CD4+ T cells, extracted from the patient’s peripheral blood and specific for ATLAS-prioritized neoantigens. Patients receive either GEN-011 in multiple fractional doses without lymphodepletion and with intermediate doses of IL-2, or as a single dose after lymphodepletion and with intermediate or high doses of IL-2.
Genocea will present clinical, preclinical, and manufacturing data at next month’s American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 to be held from April 8-13 in New Orleans. In addition, the company will host an investor call which will span the late-breaking clinical data from the TiTAN clinical trial, results demonstrating success with GEN-011’s PLANET manufacturing process, and new preclinical data on Inhibigens, antigens of pro-tumor immune responses uniquely identifiable by Genocea’s ATLAS platform.
"We are excited to present initial data on the first five patients in our TiTAN clinical trial for GEN-011," said Chip Clark, Genocea’s President and Chief Executive Officer. "We believe these data will begin to solidify the potential for GEN-011 to represent a differentiated autologous T cell therapy for solid tumors through the neoantigen selection capabilities of our ATLAS platform and the reliable expansion of T cells specific to ATLAS-validated neoantigens taken from peripheral blood by the PLANET manufacturing process."
ATLAS performance
As of March 3, 2022, Genocea has completed screening 23 patient samples with ATLAS in the TiTAN trial. On average in these samples, ATLAS has prioritized 12 neoantigens (range 0-43) and identified 16 Inhibigens (range 1-82) per patient. T cells specific for the prioritized neoantigens (and therefore not the Inhibigens) are expanded in the PLANET process.
PLANET performance
These T cells are grown in PLANET, Genocea’s robust and rapidly scalable cell expansion process. Of the 17 patient samples entering the PLANET manufacturing process, 100% have either successfully yielded a released drug product (14) or are continuing in process (3).
Of the 14 manufactured GEN-011 drug products, six have been administered to patients across both the multidose and single dose cohorts, with the remaining eight available for dosing upon patient need.

Operational updates
Strengthened Board of Directors
John Lunger was appointed to the Company’s Board of Directors, effective March 3, 2022. Mr. Lunger is Chief Patient Supply Officer at Adaptimmune, leading the teams responsible for producing and delivering products to patients, accelerating supply execution and optimizing the supply chain to be ready for commercialization. He is a seasoned biopharmaceutical leader with significant manufacturing and supply chain expertise.
Janssen Collaboration and Option Agreement
The Company entered into an R&D collaboration and option agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to explore the immunogenicity of neoantigens and the role and impact of Inhibigens in the context of vaccine therapies for cancer. The agreement was facilitated by Johnson & Johnson Innovation.
Under the collaboration, Genocea will use its clinically validated ATLAS platform to characterize Janssen-identified antigens as well as assess approaches that could mitigate the impact of Inhibigens. Genocea received an upfront technology access fee and will receive full R&D funding for its work under the collaboration. The agreement includes an option for Janssen to negotiate a future strategic partnership to develop non-personalized vaccine products using Genocea’s ATLAS platform and expertise on Inhibigens.
Upcoming presentations
American Association for Cancer Research’s (AACR) (Free AACR Whitepaper) 2022 Annual Meeting April 8-13, 2022
AACR POSTER SESSION CATEGORY: Phase 1 Adult Clinical Trials
Poster #CT153
Title: TiTAN: a phase 1 study of GEN-011, a neoantigen-targeted peripheral blood-derived T cell therapy with broad neoantigen targeting
Presenter: Maura Gillison, MD, PhD, MD Anderson Cancer Center
Date: Monday, April 11, 2022
Time: 1:30 p.m. – 5:00 p.m. CT
AACR POSTER SESSION CATEGORY: Inflammation, Immunity, and Cancer
Poster #2088
Title: The PLANET manufacturing process reproducibly generates high-quality neoantigen-targeted peripheral T cells (NPTs) for adoptive T cell therapy in the TiTAN clinical trial
Presenter: Harshal Zope, PhD, Genocea Biosciences
Date: Monday, April 11, 2022
Time: 1:30 p.m. – 5:00 p.m. CT
AACR POSTER SESSION CATEGORY: Clinical Research Excluding Trials
Poster #2745
Title: ATLAS-identified Inhibigen-specific responses accelerate tumor growth in mouse melanoma and pancreatic cancer
Presenter: Jessica Flechtner, PhD, Genocea Biosciences
Date: Tuesday, April 12, 2022
Time: 9:00 a.m. – 12:30 p.m. CT
Genocea sponsored investor call
Initial GEN-011 neoantigen-targeted peripheral T cell therapy clinical trial data to be presented
Presenter: Melissa L Johnson, MD, Sarah Cannon Research Institute
Date/Time: TBA
Needham & Company 21st Annual Healthcare Conference
Title: Corporate Overview
Presenter: Chip Clark, President and CEO, Genocea Biosciences
Date: Tuesday, April 12, 2022
Time: 2:15 p.m. ET
More information can be found for each of these presentations on our Events and Presentations page on our website genocea.com.

Financial updates
Fourth quarter 2021 financial results
•Cash position: As of December 31, 2021, cash and cash equivalents were $37.1 million compared to $79.8 million as of December 31, 2020.
•Net loss: Net loss was $13.3 million or $0.19 diluted net loss per share for the quarter ended December 31, 2021, compared to $15.0 million or $0.18 per share for the same period in 2020. Net loss was $33.2 million or $0.48 diluted net loss per share for the year ended December 31, 2021, compared to $43.7 million or $1.11 per share for the same period in 2020.
•Research and Development ("R&D") expenses: R&D expenses were $10.3 million for the quarter ended December 31, 2021, compared to $7.8 million for the same period in 2020. R&D expenses were $39.0 million for the year ended December 31, 2021, compared to $34.0 million for the same period in 2020.
The increase in R&D expenses for the quarter ended December 31, 2021 is mainly due to GEN-011 manufacturing and clinical costs partially offset by a non-recurring payroll tax credit. The increase in R&D expenses for the year ended December 31, 2021 is mainly due to GEN-011 manufacturing and clinical costs as well as headcount related costs partially offset by facility related costs.
•General and Administrative ("G&A") expenses: G&A expenses were $3.1 million for the quarter ended December 31, 2021, compared to $3.9 million for the same period in 2020. G&A expenses were $14.7 million for the year ended December 31, 2021, compared to $14.4 million for the same period in 2020.
The decrease in G&A expenses for the quarter ended December 31, 2021 is mainly due to a decrease in professional services. The increase in G&A expenses for the year ended December 31, 2021 is mainly due to growth in our internal G&A team, partially offset by decreased facility related costs.
•Other income: Other income was $0.1 million for the quarter ended December 31, 2021, compared to expense of $3.3 million for the same period in 2020. Other income was $18.9 million for the year ended December 31, 2021, compared to income of $3.3 million for the same period in 2020.
The increase in other income for the quarter ended December 31, 2021 is mainly due to the non-cash impact of the fair-value adjustment for the liability-classified warrants issued in connection with the Company’s 2018 public offering, partially offset by net interest expense. The increase in other income for the year ended December 31, 2021 is mainly due to the non-cash impact of the fair-value adjustment for the 33.6 million liability-classified warrants issued in connection with the Company’s July 2020 private placement (the "2020 Warrants"). In July 2021, the 2020 Warrants were remeasured to their fair value of $36.0 million and subsequently reclassified to equity.
Guidance
•Genocea’s existing cash is sufficient to support our current operations into Q3 2022, however we have strategic plans to extend our operations into 2023.
Conference Call
Genocea will host a conference call and webcast today at 8:30 a.m. ET Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 1066689. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea 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.