On October 29, 2020 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported its operating and financial results for the third quarter ended September 30, 2020 (Press release, Genocea Biosciences, OCT 29, 2020, View Source [SID1234569329]).
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GEN-011 Phase 1/2a clinical trial initiation
Genocea recently announced the U.S. Food and Drug Administration (FDA) accepted the company’s Investigational New Drug (IND) Application for GEN-011, an adoptive neoantigen T cell therapy designed to improve upon the limitations of TIL and TCR therapies. The company initiated a Phase 1/2a clinical study of GEN-011 in patients who have failed standard-of-care checkpoint inhibitor therapy to evaluate safety, T cell proliferation and persistence as well as clinical activity. Genocea plans to enroll up to 24 patients across several tumor types in the trial.
Scientific and clinical presentations: ESMO (Free ESMO Whitepaper) Congress, upcoming SITC (Free SITC Whitepaper) meeting and conference call
Genocea presented clinical response and immunogenicity data on the first five patients from Part B of the ongoing GEN-009 Phase 1/2a trial at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020. The incremental follow-up findings demonstrated tumor reductions or stable outcomes for all five patients, suggesting GEN-009 vaccination could be used in conjunction with CPI-based therapies to augment their effects. In addition, 100% of patients demonstrated immune responses to ATLAS-identified neoantigens.
Genocea will report additional clinical and immunogenicity data from the remaining GEN-009 Part B patients during the 2020 virtual Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting from November 9-14. The company will also provide a detailed introduction to GEN-011 and will share new insights on the utility of ATLAS-identified Inhibigens to inform future immunotherapy development.
Genocea will host a conference call on Monday, November 9 at 8:30 a.m. EST to discuss the new GEN-009 clinical and immunogenicity data reported at SITC (Free SITC Whitepaper).
Private placement
In July, Genocea completed a private placement with $74.5 million in net proceeds. The proceeds will be used to fund continued development of GEN-009, GEN-011 and ATLAS.
"In the third quarter, our team achieved important clinical, scientific and financial progress. We provided what we believe to be differentiated immunogenicity and efficacy data from an initial look at our GEN-009 Part B clinical trial and secured critical fresh capital", said Chip Clark, president and chief executive officer Genocea. "Using these proceeds to advance GEN-011 into the clinic and to further our investigation into ATLAS and its applications represents an exciting opportunity."
Third Quarter 2020 Financial Results
Cash position: As of September 30, 2020, cash and cash equivalents were $87.6 million versus $40.1 million as of December 31, 2019.
Research and Development (R&D) expenses: R&D expenses were $7.5 million for the quarter ended September 30, 2020, compared to $6.8 million for the same period in 2019.
General and Administrative (G&A) expenses: G&A expenses were $3.6 million for the quarter ended September 30, 2020, compared to $2.8 million for the same period in 2019.
Net loss: Net loss was $4.6 million for the quarter ended September 30, 2020, compared to $7.5 million for the same period in 2019.
Guidance
Genocea expects that its existing cash and cash equivalents are sufficient to support its operations to mid-2022.
Conference Call
Genocea will host a conference call and webcast today at 8:30 a.m. EDT. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 5951388. 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.