Genocea Provides Second Quarter 2020 Corporate Update
Upcoming GEN-009 data update planned for
Filed IND application for GEN-011 and is working with the FDA to provide additional information
Private Placement with Leading Life Science Investment Funds
Conference call today at
July 30, 2020, the Company plans to present initial clinical data on the first 5 patients from Part B with Dr. Maura L. Gillison, MD, PhD, Professor of Medicine, Department of Thoracic/Head and Neck Medical Oncologyat MD Anderson Cancer Center. Part B of the study is exploring the combination of GEN-009 and immune checkpoint inhibitor-based regimens in advanced solid tumors.
- Presented long-term follow-up data from Part A of the ongoing Phase 1/2a clinical trial at ASCO20 Virtual Scientific Program that evaluates eight participants for duration of immune responses and clinical outcomes.
- Seven out of eight patients treated on Part A of the study are without disease progression at one-year median follow-up.
- ATLAS™-identified neoantigens generate broad, sustained T cell responses starting after only 4 weeks and lasting for up to 1 year after the last vaccination.
- Hosted a virtual KOL symposium introducing GEN-011 – a neoantigen cell therapy that uses peripheral blood T cells and is powered by ATLAS™ to target the right tumor neoantigens. The event featured commentary from Dr.
Eric Tran, Assistant Member at the Earle A. Chiles Research Institutein the Providence Cancer Instituteand members of the Genocea management team on GEN-011 as a new category of T cell therapy designed to improve on current limitations of TIL therapy.
- Filed an Investigational New Drug (IND) application to initiate a Phase 1/2a clinical study of GEN-011 evaluating patient safety, T cell proliferation and persistence, and clinical activity. The trial expects to enroll up to 24 patients and will assess GEN-011 in a range of tumor types, with a focus on patients who have failed standard-of-care checkpoint inhibitor therapy. The Company has received verbal notification from the
U.S. Food and Drug Administration(FDA) that the agency has completed its review of the Company’s IND for GEN-011. In this verbal feedback, the FDA informed Genocea that it is placing the IND on clinical hold until it receives additional information pertaining to certain third-party reagents used in the GEN-011 manufacturing process. These reagents are not a component of the final cell therapy product. The Company expects to receive official written communication from the FDA regarding the hold and the FDA’s position in the near future and plans to work with the FDA to resolve their questions as quickly as possible.
July 22, 2020the Company entered into a private placement led by an undisclosed leading U.S.public investment fund specializing in life sciences as well as certain existing and new investors providing for the purchase of up to approximately $80 millionof its common stock and warrants to purchase shares of Genocea common stock (before deducting fees to the placement agent and other offering expenses payable by Genocea). Genocea will offer 21.4 million shares of common stock and 12.2 million pre-funded warrants to purchase common stock, along with accompanying warrants to purchase one share of common stock for each share of common stock or pre-funded warrant purchased by an investor. The warrants will be exercisable immediately upon issuance, in whole or in part, at an exercise price of $2.25per share and will have a 4-year term. The closing of the private placement is expected to occur on or about July 24, 2020, subject to customary closing conditions.
Shionogi Material Transfer Agreement (“MTA”)
- Entered into an MTA and exclusive license option with Shionogi & Co., Ltd. (“Shionogi”) to develop a novel HSV-2 vaccine using Genocea’s proprietary HSV-2 antigens from the GEN-003 program, which the company discontinued in 2017. As part of this agreement, the Company received
$2million for the exclusive option to evaluate the HSV-2 antigens and to negotiate a license prior to expiration of the MTA. Upon exercise of Shionogi’s option, terms of the license are expected to include an upfront payment, regulatory and sales milestones, as well as tiered royalties. Final terms of the license agreement will be based on results of the MTA evaluation and overall diligence. If licensed, Shionogi will assume responsibility for global development and commercialization of the HSV-2 vaccine product.
- Presented preclinical data at the AACR Virtual Annual Meeting II that furthers understanding of inhibitory antigen (InhibigenTM) function and builds on previous research demonstrating that the presence of an Inhibigen in an otherwise protective immunotherapy can be detrimental to anti-tumor responses.
- Inhibigens were found to alter the tumor microenvironment and drive tumor hyperprogression and also abolished both global and tumor antigen-specific T cell activity to beneficial anti-tumor antigens.
- Findings suggest that Inhibigens must be identified and excluded from the rational design of cancer immunotherapies to achieve more favorable patient outcomes.
“We continue to advance our clinical programs for patients living with cancer,” said
Second Quarter 2020 Financial Results
- Cash position: As of
June 30, 2020, cash and cash equivalents were $22.1 millionversus $40.1 millionas of December 31, 2019.
- Research and Development (R&D) expenses: R&D expenses were
$8.6 millionfor the quarter ended June 30, 2020, compared to $6.8 millionfor the same period in 2019.
- General and Administrative (G&A) expenses: G&A expenses were
$3.5 millionfor the quarter ended June 30, 2020, compared to $3.2 millionfor the same period in 2019.
- Net loss: Net loss was
$11.3 millionfor the quarter ended June 30, 2020, compared to $6.5 millionfor the same period in 2019.
Genocea expects that its existing cash and cash equivalents inclusive of the private placement proceeds are sufficient to support its operations to mid-2022.
Genocea will host a conference call and webcast today at
GEN-009 Clinical Update Registration
Genocea will present a clinical update on GEN-009 on
Genocea’s mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our unique ATLAS™ platform comprehensively profiles each patient’s T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in the third quarter of 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood for which we expect to conduct a Phase 1/2a clinical trial. To learn more, please visit www.genocea.com.
This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended
(Tables to follow)
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
|Cash and cash equivalents||$||22,108||$||40,127|
|Right of use assets||11,265||6,306|
|Debt, current and long-term||$||13,627||$||13,407|
|Accounts payable and accrued expenses||4,749||5,164|
|Total liabilities and stockholders’ equity||$||40,516||$||52,611|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(In thousands, except per share data)
|Three Months Ended
||Six Months Ended
|Research and development||8,587||6,849||18,574||13,309|
|General and administrative||3,480||3,217||6,868||6,234|
|Total operating expenses||12,067||10,066||25,442||19,543|
|Loss from operations||(11,161||)||(10,066||)||(24,536||)||(19,543||)|
|Other (expense) income||(160||)||3,571||362||(2,519||)|
|Net loss per share - basic and diluted||$||(0.39||)||$||(0.42||)||$||(0.84||)||$||(1.57||)|
|Weighted-average number of common shares used in computing net loss per share||29,142||15,344||28,642||14,035|
Source: Genocea Biosciences, Inc.