On October 28, 2021 Genocea Biosciences, Inc. (Nasdaq: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported a business update for the third quarter ended September 30, 2021 (Press release, Genocea Biosciences, OCT 28, 2021, View Source [SID1234592101]).

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"We continue to make significant progress. Most notably, we are very excited about our TiTAN clinical trial for GEN-011, our neoantigen-targeted peripheral T cell therapy (NPT) candidate, from which we expect to have initial data from a small subset of patients in the first quarter or early in the second quarter next year," said Chip Clark, Genocea’s President and Chief Executive Officer. "We are also pleased that our SITC (Free SITC Whitepaper) presentations will continue to showcase the neoantigen selection capabilities of our ATLAS platform, through differentiated long-term immunogenicity and clinical response data for GEN-009, our neoantigen-targeted vaccine candidate, and through its potential application to novel autoimmune disease treatments."

Operational updates

Strengthened Board of Directors

Jennifer Herron was appointed to the Company’s Board of Directors, effective September 8, 2021. Ms. Herron is currently Senior Vice President and Chief Commercial Officer at ADC Therapeutics SA ("ADCT"), leading global commercialization strategy and execution including the launch of ADCT’s first commercial product. She is a seasoned biopharmaceutical leader with extensive oncology experience.
Upcoming presentations
Festival of Biologics November 9-11, 2021 Event Details

Keynote panel discussion: What does the future of Immunotherapy hold for Oncology and Infectious Diseases
Date/Time: Tuesday, November 9, 2021 at 10:00 a.m. C.E.T.
Presentation: Unleashing the TiTANs: the GEN-011 neoantigen-targeted peripheral T cell therapy for solid tumors
Date/Time: Tuesday, November 9, 2021 at 4:50 p.m. C.E.T.
Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting November 10-14, 2021 Event Details

Poster Presentation #475: GEN-011-101 (the TiTAN-1 trial): Phase 1 study to evaluate the safety, proliferation and persistence of GEN-011, an autologous neoantigen-targeted peripheral T cell therapy in solid tumors
Poster Presentation #485: Long term results from a phase 1 trial of GEN-009, a personalized neoantigen vaccine, combined with PD-1 inhibition in advanced solid tumors
Poster Presentation #521: GEN-009, a personalized neoantigen vaccine candidate, elicits diverse and durable immune responses associated with clinical efficacy outcomes
Poster Presentation #753: InhibigenTM administration promotes aberrant T cell responses in cancer but may be beneficial for amelioration of autoimmune disease
Poster Presentation #248: Empiric profiling of peripheral T cell recall responses to tumor mutanomes versus in silico predictions in NSCLC patients undergoing pembrolizumab treatment ± chemotherapy
Date/Time: ePosters will be on display on the SITC (Free SITC Whitepaper) 2021 virtual meeting platform on Friday, November 12, 2021 at 7:00 a.m. E.T.
Cellular Immunotherapies for Solid Tumors Summit November 16-18, 2021 Event Details

Presentation: GEN-011 PLANET Process: A Robust and Rapidly Scalable Manufacturing Process to Generate Neoantigen-targeted Peripheral T cells (NPTs)
Date/Time: Wednesday, November 17, 2021 at 4:30 pm E.T.
World Vaccine & Immunotherapy Congress November 30-December 2, 2021 Event Details

Panel discussion: Are neoantigens living up to their initial promise? What questions remain unanswered?
Date/Time: Wednesday, December 1, 2021 at 11:40 a.m. P.T.
Financial updates

Third quarter 2021 financial results

Cash position: As of September 30, 2021, cash and cash equivalents were $48.9 million compared to $79.8 million as of December 31, 2020.

Net loss: Net loss was $3.6 million or $0.05 diluted net loss per share for the quarter ended September 30, 2021, compared to $4.6 million or $0.26 per share for the same period in 2020. Net loss was $19.9 million or $0.54 diluted net loss per share for the nine months ended September 30, 2021, compared to $28.7 million or $1.01 per share for the same period in 2020.

Research and Development ("R&D") expenses: R&D expenses were $9.5 million for the quarter ended September 30, 2021, compared to $7.5 million for the same period in 2020. R&D expenses were $28.7 million for the nine months ended September 30, 2021, compared to $26.1 million for the same period in 2020.

The increase in R&D expenses for both periods is mainly due to growth in our internal research and manufacturing teams and GEN-011 manufacturing and clinical costs.
General and Administrative ("G&A") expenses: G&A expenses were $3.9 million for the quarter ended September 30, 2021, compared to $3.6 million for the same period in 2020. G&A expenses were $11.6 million for the nine months ended September 30, 2021, compared to $10.5 million for the same period in 2020.

The increase in G&A expenses for both periods is mainly due to growth in our internal G&A team, partially offset by decreased facility costs.
Other income: Other income was $8.1 million for the quarter ended September 30, 2021, compared to $6.2 million for the same period in 2020. Other income was $18.8 million for the nine months ended September 30, 2021, compared to $6.5 million for the same period in 2020.
The increase in other income for both periods 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"). During the quarter ended September 30, 2021, the 2020 Warrants were remeasured to their fair value of $36.0 million and subsequently reclassified to equity.

Guidance

Genocea’s operating plan extends its cash runway into the third quarter of 2022.
Conference Call
Genocea will host a conference call and webcast today at 8:30 a.m. E.T. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 8729366. 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.