Initial GEN-011 clinical trial data to be presented at AACR
Conference call today at
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
“We are excited to present initial data on the first five patients in our TiTAN clinical trial for GEN-011,” said
ATLAS performance
As of
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
Janssen Collaboration and Option Agreement
The Company entered into an R&D collaboration and option agreement with
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
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: | ||
Date: | ||
Time: | ||
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, | ||
Date: | ||
Time: | ||
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: | ||
Date: | ||
Time: | ||
Genocea sponsored investor call | ||
Initial GEN-011 neoantigen-targeted peripheral T cell therapy clinical trial data to be presented | ||
Presenter: Melissa L Johnson, MD, | ||
Date/Time: TBA | ||
Title: Corporate Overview | ||
Presenter: | ||
Date: | ||
Time: | ||
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 ofDecember 31, 2020 . - Net loss: Net loss was
$13.3 million or$0.19 diluted net loss per share for the quarter endedDecember 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 endedDecember 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 endedDecember 31, 2021 , compared to$7.8 million for the same period in 2020. R&D expenses were$39.0 million for the year endedDecember 31, 2021 , compared to$34.0 million for the same period in 2020. The increase in R&D expenses for the quarter endedDecember 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 endedDecember 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 endedDecember 31, 2021 , compared to$3.9 million for the same period in 2020. G&A expenses were$14.7 million for the year endedDecember 31, 2021 , compared to$14.4 million for the same period in 2020. The decrease in G&A expenses for the quarter endedDecember 31, 2021 is mainly due to a decrease in professional services. The increase in G&A expenses for the year endedDecember 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 endedDecember 31, 2021 , compared to expense of$3.3 million for the same period in 2020. Other income was$18.9 million for the year endedDecember 31, 2021 , compared to income of$3.3 million for the same period in 2020.
The increase in other income for the quarter endedDecember 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 endedDecember 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'sJuly 2020 private placement (the “2020 Warrants”). InJuly 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
About
Genocea’s mission is to identify the right tumor targets to develop life-changing immunotherapies for people suffering from cancer. Our proprietary ATLAS™ platform can comprehensively profile each patient’s T cell responses to potential targets, or antigens, on that patient’s tumor. ATLAS zeroes in on both antigens that activate anti-tumor T cell responses and inhibitory antigens, Inhibigens™, that drive pro-tumor immune responses. We are conducting a Phase 1/2a clinical trial for GEN-011, our investigational adoptive T cell therapy comprising neoantigen-targeted peripheral cells. We continue to monitor patients in our phase 1/2a clinical trial for GEN-009, our investigational neoantigen vaccine. In addition to our two clinical programs, we are conducting research in several areas where we believe ATLAS could be a key tool in optimizing antigen selection for therapies across a number of diseases. To learn more, please visit https://www.genocea.com.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act, including statements related to GEN-011 and the anticipated timing of top-line results from its Phase 1/2a clinical trial, the PLANET manufacturing process and research efforts, including with regard to ATLAS and Inhibigens. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. These factors include, but are not limited to, risks related to our substantial dependence on GEN-011 where any failure to successfully develop GEN-011, or any significant delays in doing so, will have a material adverse effect on Genocea; the potential failure of GEN-011, which is in an early stage of clinical development; potential delays in enrolling patients in the GEN-011 study; our reliance on third parties to conduct technical development, non-clinical studies and clinical trials for our product candidates; our reliance on third parties to conduct some or all aspects of our product manufacturing; that GEN-011 is uniquely manufactured for each patient and the potential difficulties in production, particularly with respect to scaling our manufacturing capabilities; our ability to obtain or protect intellectual property rights related to our product candidates; the potential impacts of COVID-19 on our business and financial results; changes in law, regulations, or interpretations and enforcement of regulatory guidance; our need for additional financing and the risks listed under "Risk Factors" in our annual report on Form 10-K for the year ended
(Tables to follow)
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
(In thousands)
2021 | 2020 | ||||
Cash and cash equivalents | $ | 37,148 | $ | 79,769 | |
Property and equipment, net | 5,841 | 5,123 | |||
Right of use assets | 7,420 | 9,308 | |||
Other assets | 5,558 | 4,293 | |||
Total assets | $ | 55,967 | $ | 98,493 | |
Accounts payable and accrued expenses | $ | 9,996 | $ | 7,878 | |
Debt, current and long-term | 8,787 | 13,862 | |||
Lease liabilities | 8,398 | 10,012 | |||
Deferred revenue | 1,700 | 1,641 | |||
Warrant liabilities | 11 | 56,118 | |||
Total liabilities | 28,892 | 89,511 | |||
Stockholders' equity | 27,075 | 8,982 | |||
Total liabilities and stockholders’ equity | $ | 55,967 | $ | 98,493 | |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(In thousands, except per share data)
Three Months Ended | Twelve Months Ended | ||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||
License revenue | $ | — | $ | — | $ | 1,641 | $ | 1,359 | |||
Operating expenses: | |||||||||||
Research and development | 10,283 | 7,837 | 39,020 | 33,960 | |||||||
General and administrative | 3,126 | 3,877 | 14,714 | 14,388 | |||||||
Total operating expenses | 13,4099 | 11,714 | 53,734 | 48,348 | |||||||
Loss from operations | (13,409) | (11,714) | (52,093) | (46,989) | |||||||
Other income | 129 | (3,271) | 18,897 | 3,275 | |||||||
Net loss | $ | (13,280) | $ | (14,985) | $ | (33,196) | $ | (43,714) | |||
Net loss per share: | |||||||||||
Basic | $ | (0.19) | $ | (0.23) | $ | (0.48) | $ | (0.98) | |||
Diluted | $ | (0.19) | $ | (0.18) | $ | (0.48) | $ | (1.11) | |||
Weighted-average number of shares used in computing net loss per share: | |||||||||||
Basic | 70,402 | 64,625 | 68,575 | 44,436 | |||||||
Diluted | 70,402 | 66,954 | 68,575 | 46,553 | |||||||
Investor Contact: | Media Contact: | |
Sarah O’Connell | ||
daniel@lifesciadvisors.com | soconnell@vergescientific.com |
Source:
2022 GlobeNewswire, Inc., source