- April 2018: Genocea scientists presented data at the 2018 Annual Meeting of the American Association for Cancer Research (AACR) further highlighting the advantages of its ATLAS platform over in silico methods in identifying both neoantigens for vaccine inclusion and “inhibitory” neoantigens for exclusion and detailing the development of a novel model to study the mechanism of inhibitory antigens identified by ATLAS.
- April 2018: Genocea filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin clinical development of GEN-009.
- May 2018: Genocea announced the acceptance of the GEN-009 IND by the FDA. Genocea is currently conducting a Phase 1/2a clinical trial for GEN-009 in patients with a variety of tumor types and expects to report top-line immune response data from the initial patient cohort in the first half of 2019.
- Cash Position: As of June 30, 2018, cash and cash equivalents were $44.2 million compared to $12.3 million as of December 31, 2017.
- Research and Development (R&D) Expenses: R&D expenses were $5.3 million for the quarter ended June 30, 2018, compared to $11.4 million for the same period in 2017. This decrease was largely due to reduced headcount, external development, lab, clinical, and other R&D costs.
- General and Administrative (G&A) Expenses: G&A expenses were $4.5 million for the quarter ended June 30, 2018, compared to $3.6 million for the same period in 2017. This increase was primarily due to increased consulting and professional services costs, offset by reduced compensation and benefits costs.
- Other Income (Expense): Other Income for the quarter ended June 30, 2018 was $5.4 million compared to Other Expense of $0.4 million for the same period in 2017. Other Income for the second quarter of 2018 is primarily comprised of the non-cash change in fair value of warrants to purchase shares of Genocea common stock.
- Net Loss: Net loss was $4.4 million for the quarter ended June 30, 2018, compared to a net loss of $15.4 million for quarter ended June 30, 2017.
Also during the second quarter, Genocea amended its loan and security agreement with Hercules Capital, Inc., to provide up to $14.0 million in debt financing in the form of a term loan. The previous agreement, entered into in 2014, had provided up to $27.0 million in debt financing. This amended loan agreement provides for interest-only payments until June 1, 2019; this date may be extended should certain performance milestones be met.
GENOCEA BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
|June 30, 2018||December 31, 2017|
|Cash and cash equivalents||$||44,215||$||12,273|
|Debt, current and long-term||$||14,468||$||14,311|
|Accrued expenses and other liabilities||3,136||5,711|
|Stockholders' equity (deficit)||13,865||(6,050||)|
|Total liabilities and stockholders’ equity (deficit)||$||49,040||$||17,488|
GENOCEA BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(In thousands, except per share amounts)
|Three Months Ended |
|Six Months Ended |
|Research and development||$||5,316||11,427||12,591||21,169|
|General and administrative||4,472||3,571||7,581||7,205|
|Total operating expenses||9,788||14,998||20,172||28,374|
|Loss from operations||(9,788||)||(14,998||)||(20,172||)||(28,374||)|
|Other income (expense):|
|Change in fair value of warrants||5,498||—||199||—|
|Interest expense, net||(241||)||(370||)||(442||)||(728||)|
|Other income (expense)||93||(7||)||87||(8||)|
|Total other income (expense)||5,350||(377||)||(156||)||(736||)|
|Other comprehensive loss:|
|Unrealized gain on available-for-sale securities||—||3||—||—|
|Net loss per share - basic and diluted||$||(0.05||)||$||(0.54||)||$||(0.26||)||$||(1.02||)|
|Weighted-average number of common shares used in computing net loss per share||85,538||28,541||78,428||28,519|