On July 30, 2020 Gilead Sciences, Inc. (Nasdaq: GILD) reported that the company’s Board of Directors has declared a cash dividend of $0.68 per share of common stock for the third quarter of 2020 (Press release, Gilead Sciences, JUL 30, 2020, View Source [SID1234562648]). The dividend is payable on September 29, 2020, to stockholders of record at the close of business on September 15, 2020. Future dividends will be subject to Board approval.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

On July 30, 2020 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) and TerSera Therapeutics LLC reported that they have entered into an asset purchase and sale agreement for the sale to TerSera of Lexicon’s rights, title and interest in XERMELO (telotristat ethyl) (Press release, Lexicon Pharmaceuticals, JUL 30, 2020, View Source;020.htm [SID1234562634]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Pursuant to the terms of the agreement, TerSera will pay Lexicon approximately $159 million in cash at closing, which includes a $155 million upfront payment and approximately $4 million for existing inventory. Lexicon may receive additional development, regulatory and sales milestone payments of up to an aggregate of $65 million for the development and commercialization of telotristat ethyl in patients with biliary tract cancer. Additionally, Lexicon will be eligible to receive mid-teens royalties on net sales of XERMELO in biliary tract cancer. As part of the transaction, TerSera has agreed to assume the currently ongoing TELE-ABC Phase 2 clinical study of XERMELO in biliary tract cancer patients and offer employment to at least 20 Lexicon employees currently dedicated to XERMELO. The transaction is expected to close in the third quarter of 2020, subject to customary closing conditions.

"This agreement allows us to focus Lexicon around LX9211 for neuropathic pain and other early-stage research and development programs, enabling efficient use of our resources and substantially reducing our debt," said Lonnel Coats, Lexicon’s president and chief executive officer. "TerSera’s dedicated oncology focus will provide physicians and patients continued access to this important medicine for carcinoid syndrome diarrhea and continue its ongoing development for people suffering with biliary tract cancer."

"XERMELO continues to gain an increasingly important role in carcinoid syndrome diarrhea with a potential future role in other cancers," said Ed Fiorentino, Chairman & CEO of TerSera. "We are very excited to add XERMELO to our existing oncology portfolio."

About XERMELO (telotristat ethyl)

Discovered using Lexicon’s unique approach to gene science, XERMELO is the first and only approved oral therapy for carcinoid syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with mNETs and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

Lexicon has granted Ipsen an exclusive royalty-bearing right and license to commercialize XERMELO outside of the United States and Japan. Lexicon is commercializing XERMELO in the United States and Ipsen is commercializing XERMELO in multiple countries, including the United Kingdom and Germany.

XERMELO (telotristat ethyl) Important Safety Information

•Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking

XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
•Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
•Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.

On July 30, 2020 OPKO Health, Inc. (NASDAQ: OPK) reported business highlights and financial results for the three months ended June 30, 2020 (Press release, Opko Health, JUL 30, 2020, View Source;20.htm [SID1234562623]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Second Quarter Business Highlights

BioReference Laboratories increased COVID-19 testing nationwide: During the second quarter, BioReference Laboratories (BRL) announced numerous partnerships and testing agreements with states, cities, professional sports associations and healthcare organizations, including the New York State Department of Health, New York City Health and Hospital Corporation and MagnaCare. Further, BRL provided testing services for more than 500 drive-thru and retail testing sites around the country. In July 2020, the Company announced that the Centers for Disease Control and Prevention (CDC) awarded BRL an Indefinite Delivery Indefinite Quantity contract to provide Commercial Surge Capacity Testing for COVID-19, under which BRL will perform antibody testing to determine COVID-19 seroprevalence and other testing with key demographic data for the next four months.

BRL processed approximately 2.2 million COVID-19 molecular tests during the second quarter and currently has a capacity of more than 50,000 daily. Since late April, when BRL began offering COVID-19 serology testing to measure SARS-CoV-2 specific antibody levels, it has performed approximately 331,600 tests with a significantly greater capacity.

Successful 4Kscore Medicare appeal for tests performed during 2019: As previously announced, Novitas Solutions issued its final Local Coverage Determination for Medicare payments for the 4Kscore test with defined coverage criteria, effective December 30, 2019. The Company received a favorable Medicare appeal decision from Novitas for previously denied Medicare claims for 4Kscore tests performed in 2019. The COVID-19 pandemic impacted utilization of 4Kscore during the second quarter as many urology practices were either closed or operating at reduced capacity. More than 8,400 tests were performed during the quarter despite fewer patient visits and access to physicians. The volume of 4Kscore tests has been increasing in recent weeks with the gradual re-opening of the economy and patients resuming visits to their physicians.

Positive somatrogon topline results reported from Japan pediatric Phase 3 efficacy and safety study: In June, OPKO announced that its Japan Phase 3 clinical trial met its primary and secondary objectives, and demonstrated that the efficacy and safety of somatrogon administered once-weekly were comparable to GENOTROPIN (somatropin) administered once-daily as measured by annual height velocity after 12 months of treatment in treatment-naïve Japanese pre-pubertal children with

growth hormone deficiency. The findings were consistent with the results previously reported from the Company’s global Phase 3 study.

Somatrogon abstracts presented at Endocrine Society’s ENDO Online 2020: Two abstracts regarding the somatrogon global Phase 3 trial were presented at ENDO Online 2020 by Cheri Deal, PhD, MD, FRCPC, Chief of Pediatric Endocrinology and Diabetes at CHU Sainte-Justine and Tenured Professor of Pediatrics at Université de Montréal, the Principal Investigator of the study. The two abstracts, "Somatrogon Growth Hormone in the Treatment of Pediatric Growth Hormone Deficiency: Results of the Pivotal Phase 3", and "Interpretation of Insulin-like Growth Factor (IGF-1) Levels Following Administration of Somatrogon (a long-acting Growth Hormone-hGH-CTP)," were published online in the April-May supplemental issue of the Journal of Endocrine Society. Dr. Deal’s presentation included data demonstrating that somatrogon administered once weekly, met its endpoint of non-inferiority to daily GENOTROPIN (somatropin) in height velocity and height standard deviation score (SDS). In addition, Dr. Deal presented new data demonstrating that over 95% of patients had mean IGF-1 SDS levels within the normal range. IGF-1 SDS is a biomarker to evaluate efficacy and safety of human growth hormone replacement therapy.

Somatrogon global regulatory submissions: The somatrogon Biologics License Application (BLA) submission in the U.S. is anticipated to occur in the fall of 2020. In Europe, the Company’s open-label study demonstrating benefit and compliance with reduced treatment burden will be completed this quarter, enabling Pfizer to submit for regulatory approval in Europe early next year. The somatrogon regulatory submission in Japan is expected during the first half of 2021.

RAYALDEE total prescriptions reported by IQVIA increased 45% in the second quarter of 2020 compared with the second quarter of 2019: Total prescriptions for the three months ended June 30, 2020 increased to approximately 18,400, compared to approximately 12,700 for the second quarter of 2019. During the second quarter of 2020, demand for RAYALDEE remained strong but prescription growth was impacted by limited access to physician offices by both patients and OPKO’s sales representatives.

RAYALDEE authorized for Phase 2 clinical trial in patients with mild-to-moderate COVID-19: On June 1, 2020, OPKO announced that the U.S. Food and Drug Administration (FDA) authorized the Company to undertake a Phase 2 trial with RAYALDEE as a treatment for patients with mild-to moderate COVID-19. The trial, entitled "A Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of RAYALDEE (calcifediol) Extended-release Capsules to Treat Symptomatic Patients Infected with SARS-CoV-2 (REsCue)," will enroll approximately 160 subjects, including many with stage 3 or 4 chronic kidney disease. The REsCue trial will have four weeks of treatment with RAYALDEE or placebo and two weeks of follow-up. There are two primary efficacy endpoints: time to resolution of COVID-19 symptoms; and consistent attainment of serum total 25-hydroxyvitamin D levels greater than or equal to 50 ng/mL during the last week of treatment. The trial is expected to begin enrolling subjects later this quarter.

Second Quarter Financial Results

Consolidated revenues for the second quarter of 2020 were $301.2 million compared with $226.4 million for the comparable period of 2019. Net income for the second quarter of 2020 was $33.7 million, or $0.05 per diluted share, compared with a net loss of $59.8 million, or $0.10 per share, for the comparable period of 2019.

Diagnostics: Revenue from services in the second quarter of 2020 was $251.0 million compared with $178.5 million in the prior-year period, primarily due to increased COVID-19 testing volumes, partially offset by reduced clinical and genomic test volumes due to physician office closures and stay-at-home orders relating to the pandemic. In addition, the Company received a $6.2 million grant from the CARES Act in the second quarter. Total costs and expenses were $216.2 million in the second quarter of 2020 compared with $206.5 million in the second quarter of 2019. Operating income was $40.9 million in the second quarter of 2020 compared with an operating loss of $28.0 million in the prior-year period, an improvement of $68.9 million.

Pharmaceuticals: Revenue from products in the second quarter of 2020 was $29.3 million compared with $28.7 million in in the second quarter of 2019, with the increase primarily attributable to higher sales of RAYALDEE of $8.6 million in the second quarter of 2020 compared with $5.7 million in the prior-year period. Revenue from licensing and intellectual property was $14.7 million in the second quarter of 2020 compared with $19.2 million in the second quarter of 2019, with the reduction primarily due to a decrease in the amortization of payments received from Pfizer, OPKO’s commercial partner for its long-acting human growth hormone product, somatrogon. Total costs and expenses were $50.0 million in the second quarter of 2020 compared with $56.5 million in the prior-year period, with the decline primarily attributable to lower research and development expenses due to the completion of the pediatric Phase 3 trial. The operating loss was $6.0 million in the second quarter of 2020 compared with $8.6 million in the second quarter of 2019.

Cash and equivalents: Cash, cash equivalents and marketable securities were $21.6 million as of June 30, 2020. In addition, the Company has availability under its line of credit with JP Morgan of $15.3 million and an unutilized $100 million credit facility that provides access to incremental capital on a non-dilutive basis.

CONFERENCE CALL & WEBCAST INFORMATION

OPKO’s senior management will provide a business update and discuss results in greater detail during a conference call and live audio webcast at 4:45 p.m. Eastern time today, July 30, 2020. Participants are requested to pre-register for the conference call using the link here, or dialing (888) 869-1189 or (706) 643-5902 and using conference ID 6946539. Upon registering, participants will receive dial-in numbers, an event passcode and a unique registrant ID to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the start of the call.

To access the live call via webcast, please click on the link OPKO 2Q20 Results Conference Call. Individual investors and investment community professionals who do not plan to ask a question during the call’s Q&A session are encouraged to listen to the call via the webcast.

For those unable to listen to the live conference call, a replay can be accessed for a period of time on OPKO’s website at OPKO 2Q20 Results Conference Call. A telephone replay will be available beginning

approximately two hours after the close of the conference call. To access the replay, please dial (855) 859-2056 or (404) 537-3406, and use conference ID 6946539.

On July 30, 2020 Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, reported financial and operating results for the second quarter ended June 30, 2020, and provided a corporate update (Press release, Oncocyte, JUL 30, 2020, View Source [SID1234562622]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Oncocyte is a much stronger company today than when I stepped into the CEO role a year ago with two acquisitions that de-risked our product portfolio by adding two proprietary, well validated and published tests to our menu," said Ron Andrews, Chief Executive Officer of Oncocyte. "The second quarter proved to be an important chapter in the evolution of Oncocyte as we continue to gain momentum with our two commercial products with multiple important milestones for DetermaRxTM, which include securing national Medicare payment, revenue generation with reimbursements from multiple payers, a solid increase in physician adoption, increased testing volume with now well over 100 patients tested, and global distribution in Israel, India, the Middle East and Africa. In addition, with our compelling clinical data, the final LCD from Noridian established a new class of predictive tests for Medicare coverage in NSCLC, with DetermaRx now positioned as the first and only test in this class. This is a momentous accomplishment that establishes Oncocyte as a true pioneer in the advancement of molecular diagnostics for lung cancer."

Mr. Andrews continued, "We also continue our progress with DetermaIOTM with data presented at ASCO (Free ASCO Whitepaper) that demonstrated the potential utility of DetermaIO for immunotherapy response prediction in triple negative breast cancer, the deadliest form of breast cancer. These data, combined with the lung cancer data presented at SITC (Free SITC Whitepaper) in 2019, suggest that DetermaIO may have broad applicability in solid tumors regardless of tissue type, which could enable our access to the estimated $5 billion and rapidly growing molecular diagnostic market for both comprehensive profiling to identify patients likely to respond to immune therapy and identifying patients who may require combination therapy to attain full sustained responses. We are actively pursuing near-term opportunities in both pharma services and academia for immunotherapy trials as we advance toward our ultimate goal of clinical launch and use of DetermaIO. Our continued track record of consistent execution with DetermaRx and DetermaIO, combined with our growing pharma services lab opportunity which has secured over $1 million in pharma services contracts already this year, positions Oncocyte for rapid revenue growth as an innovative leader in molecular diagnostics for lung cancer, TNBC and potentially other solid tumors."

Recent Corporate Highlights

●DetermaRx

○Announced final Medicare local coverage determination (LCD) from both Noridian Healthcare Solutions and Palmetto GBA securing national Medicare payment for DetermaRx starting in August 2020
○Noridian Healthcare Solutions LCD established a new class of predictive tests for Medicare coverage, based on compelling DetermaRx clinical evidence

●Noridian Healthcare Solutions LCD positions DetermaRx as the first and only test in this class for early-stage non-small cell lung cancer

○Announced commercial availability in January and now have 47 sites onboarded, including a number of community healthcare systems where most early stage cancer is treated
○Rapid growth of DetermaRx physician adoption has resulted in over 100 patients tested, and a physician reorder rate of 60%
○Expanded international availability through a distribution agreement with ProGenetics Ltd, adding commercial availability of DetermaRx to Israel, which is complementary to the prior agreement with CORE Diagnostics for India, the Middle East and Africa
○Announced publication of new long-term follow up data for DetermaRx in the American Journal of Respiratory and Clinical Care Medicine demonstrating potential clinical utility and benefit to patients and payers through reduced post-surgery follow-up of lung cancer patients
○Continued successful physician engagement with both virtual and in-person activities with over 1,800 participants in online physician education programs
○Announced KOL webinar showcasing new data and real-world usage of DetermaRx featuring renowned lung cancer experts Dr. David Gandara and Dr. Johannes Kratz on July 30, 2020

●DetermaIO

○Presented data at 2020 ASCO (Free ASCO Whitepaper) Virtual Meeting highlighting the potential utility of DetermaIO for immunotherapy response prediction in triple-negative breast cancer. In this study, DetermaIO outperformed standard of care PD-L1 testing in identifying responders to the FDA-approved checkpoint inhibitor atezulimab
○Announced KOL webinar featuring MD Anderson breast cancer medical oncologist, and triple negative study Principal Investigator, Dr. Naeto Ueno on August 19, 2020
○Initiated an Investigator Sponsored Trial utilizing DetermaIO as the predictive biomarker for an FDA-approved checkpoint inhibitor in the early stage neoadjuvant setting
○Continued advancement of pharma services opportunities, including immunotherapy trials and the potential for development of companion diagnostics for lung cancer and other solid tumors

●Pharma Services

○Continued growth of pharma services offering with a full suite of molecular analyses including tissue and blood-based technologies, proprietary platforms such as DetermaIO and TNBCType Assay, as well as custom next-generation sequencing and PCR services including whole exome sequencing, RNA-seq and targeted mutation panels
○Closed over $1M in secured pharma services contracts
○With collaborators from MD Anderson Cancer Center, announced the peer-reviewed publication in PLOS One with data demonstrating the utility of the TNBCType Assay to inform triple-negative breast cancer drug development by identifying the most suitable cell lines to help biopharma and academic researchers develop new treatments

●Financial and Corporate

○In April, Oncocyte successfully completed a $10.7 million registered offering of common shares, priced at the market, directly with fundamentally driven, healthcare focused institutional investors.

Second Quarter 2020 Financial Highlights

At June 30, 2020, Oncocyte had cash, cash equivalents and marketable securities of $17.1 million as compared to $22.5 million at December 31, 2019.

Prior to January 1, 2020, Oncocyte had no revenues. Oncocyte currently derives its revenues from pharma services generated by its wholly owned subsidiary, Insight Genetics, which was acquired on January 31, 2020, and from the cash basis receipts from the sale of its lung cancer test, DetermaRx, which was commercially launched in early 2020.

Under U.S. accounting principles, Oncocyte will be able to recognize revenues for DetermaRx on an accrual basis of accounting once it has contracts for reimbursement from third-party payers or a history of experience of cash collections for the tests performed, or both. Until that time, Oncocyte expects to recognize revenue for DetermaRx tests performed on a cash basis. Accordingly, Oncocyte will incur and accrue cost of revenues and other operating expenses related to its diagnostic tests, including DetermaRxTM.

Beginning on January 31, 2020, Oncocyte’s consolidated financial statements and results also include the results from its wholly owned subsidiary, Insight Genetics, which Oncocyte acquired on that date.

For the second quarter ended June 30, 2020, Oncocyte reported a net loss of $9.1 million, or $(0.14) per share, as compared to $5.4 million, or $(0.10) per share, for the second quarter ended June 30, 2019.

Operating losses, as reported, for the second quarter of 2020 were $8.8 million, an increase of $3.3 million from $5.5 million as compared to the second quarter of 2019; and operating losses, on an adjusted basis, were $6.9 million, an increase of $2.2 million from $4.7 million as compared to the second quarter of 2019.

Oncocyte has provided a reconciliation between GAAP and non-GAAP operating losses in the financial tables, included with this earnings release, which it believes is helpful in understanding its ongoing operations.

Revenues for the three and six months ended June 30, 2020 were $143,000 and $158,000, respectively, primarily generated from pharma services, as revenues from DetermaRx tests were recognized only when Oncocyte received cash payment for the test rather than on an accrual basis when the tests were performed.

Cost of revenues for the three and six months ended June 30, 2020 were $0.4 million and $0.5 million, respectively, primarily incurred from performing the DetermaRx tests and pharma services.

Research and development expenses for second quarter of 2020 were $3.2 million as compared to $1.5 million for the same period in 2019, an increase of $1.7 million primarily attributable to personnel, outside services and laboratory related expenses for Clinical Validation activities of DetermaDx.

General and administrative expenses for the second quarter of 2020 were $3.8 million, as compared to $3.6 million for the same period in 2019, which remained relatively unchanged from the prior year comparative period.

Sales and marketing expenses for the three months ended June 30, 2020, were $1.6 million, as compared to $0.3 million for the same period in 2019, an increase of $1.3 million. The increase was primarily due personnel and related expenses for ramp up in sales and marketing activities for commercialization of DetermaRx.

Cash used in operations was $7.0 million for the second quarter of 2020, which included some transactional, acquisition-related legal and business development costs paid this quarter of approximately $1 million.

Conference Call

The Company will host a conference call today, July 29, 2020, at 4:30 pm EDT / 1:30 pm PDT to discuss the results along with recent corporate developments.

The dial-in number in the U.S./Canada is 877-407-9716; for international participants, the number is 201-493-6779. For all callers, please refer to Conference ID 13706018. To access the live webcast, go to the investor relations section on the Company’s website, or by clicking here: View Source

On July 30, 2020 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported that it will present initial clinical data on the first five patients from Part B of the ongoing Phase 1/2a study, which explores the combination of Genocea’s neoantigen vaccine, GEN-009 and checkpoint inhibitor-based regimens (CPI) in advanced solid tumors (Press release, Genocea Biosciences, JUL 30, 2020, View Source [SID1234562617]). The webcast and presentation will feature Dr. Maura L. Gillison, MD, PhD, Professor of Medicine, Department of Thoracic/Head and Neck Medical Oncology at MD Anderson Cancer Center.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The trial combines GEN-009 with a Standard of Care (SOC) CPI-based regimen approximately four months after the SOC CPI-based regimen is started. The preliminary findings from the first five patients show three achieving independent RECIST responses starting from the first GEN-009 dose. These responses show an acceleration of shrinkage beyond that of the CPI regimen, creating a novel response plot that supports the effect being attributable to the addition of GEN-009. One such patient achieved a complete response ("CR"), while two demonstrated partial responses ("PR"). Overall, two of the first five patients achieved CRs and three experienced PRs.

These results are corroborated by the patients’ immune responses. Neoantigen-specific CD4+ and CD8+ T cell responses were detected in 100% of patients, with all patients responding to multiple vaccinated antigens. Early comparison of T cell responses post-checkpoint (pre-vaccination) and post-vaccination show that T cell responses are specific to GEN-009 and not augmented by checkpoint blockade.

"We are incredibly encouraged by these initial results," said Dr. Gillison. "The breadth and magnitude of immune responses validate the complete and partial responses observed in the five patients evaluated. We believe incorporating GEN-009 into standard-of-care immunotherapy regimens may help boost the effectiveness of immune checkpoint inhibitor therapy in patients with advanced disease."

"We are very pleased this initial data set continues to validate antigen selection using our proprietary ATLAS platform," said Chip Clark, President and Chief Executive Officer, Genocea. "We look forward both to reporting data from approximately ten additional patients this fall and to initiating the clinical trial for the neoantigen cell therapy GEN-011, which should similarly benefit from ATLAS to drive anti-tumor responses through T cells targeting the right neoantigens in checkpoint-refractory patients."

Webcast & Conference Call Information
Interested participants may access the call by clicking here. For those who are unable to listen in during the event, a replay of the call will be available here.

A replay of the webcast will be archived for 30 days following the presentation by visiting the "Events and Presentations" tab of the investor relations section of the Genocea website at View Source