- Discovery collaboration underway with
Center for Cellular Immunotherapies Lab atUniversity of Pennsylvania to Study Combinations of Novel Viral Immunotherapy and CAR-T Cell Therapy Candidates in Solid Tumor Models - Upcoming clinical data presentations at SITC and SNO Annual Meetings
- Virtual R&D Day on
December 6, 2022 , with Candel leadership and renowned oncology experts
“Candel made important progress across multiple facets of the organization this quarter,” said
Third Quarter 2022 and Recent Highlights
- In August, the Company enhanced its Board of Directors with the appointments of three new Board members. (View Release)
Joseph Papa , Chief Executive Officer of Bausch + Lomb CorporationGary Nabel , MD, PhD, Chief Innovation Officer of OPKO and Chief Executive Officer,ModeX Therapeutics, Inc. , an OPKO Health companyRenee Gaeta , Chief Financial Officer of Eko Devices
- In September, the Company strengthened its executive leadership team with appointments of
Jason A. Amello as Chief Financial Officer andGarrett Nichols , MD, MS, as Chief Medical Officer. (View Release) - Separately in September, the Company submitted the protocol for a phase 3 clinical trial evaluating CAN-2409 in patients living with high-grade glioma (HGG) to a central institutional review board.
- Also in September, the
European Medicines Agency (EMA) issued a positive opinion for orphan drug designation for CAN-2409 in glioma. (View Release) - In October, the
European Commission adopted the EMA’s decision to grant CAN-2409 orphan drug designation for the treatment of glioma.
- Also in October, the Company formed a partnership with
Neil Sheppard , DPhil, Director of theT Cell Engineering Lab at the University of Pennsylvania’sCenter for Cellular Immunotherapies , led by Carl. H June, MD, the Richard W. Vague Professor of Immunotherapy, to study combinations of novel viral immunotherapy and CAR-T cell therapy candidates in solid tumors. (View Release) - In early November,
Dr. Tak participated in separate fireside chats withCredit Suisse and BMO Capital Markets . (View Webcasts)
Key Upcoming Milestones and Events
- 37th Annual Meeting of the
Society for Immunotherapy of Cancer (SITC) (View Release)- On
November 11 ,Anne R. Diers , PhD, Director ofEarly Research at Candel, will lead an in-person poster session on pre-clinical CAN-2409 data. - Also on
November 11 ,Patrick Y. Wen , MD, Principal Investigator fromDana-Farber Cancer Institute , will present new data in an in-person oral session on CAN-2409 in combination with nivolumab and standard of care from the Company’s phase 1b clinical trial in newly diagnosed HGG.
- On
- On
November 16 ,Dr. Tak will take part in an in-person fireside chat atJefferies London Healthcare Conference . (Register Here) - 27th Annual Meeting of the
Society for Neuro-Oncology (SNO) (View Release)- On
November 18 , new clinical data from the Company’s phase 1 trial of CAN-3110 in recurrent HGG will be presented in an in-person oral session byAlexander Ling , PhD, a Postdoctoral Research Fellow from Brigham and Women’s Hospital.
- On
- On
December 6 , the Company will hold its virtual R&D Day with leadership and renowned oncology experts to present an in-depth overview of the Company’s viral immunotherapy platforms and clinical pipeline including additional data from its phase 2 clinical trial of CAN-2409 in combination with anti-PD-1 or PD-L1 agents in patients with stage III/IV non-small cell lung cancer.
Financial Results for the Quarter Ended
Research and Development Service Revenue, related party: Research and Development Service Revenue, related party, for the third quarters ended
Research and Development Expenses: Research and development expenses were
General and Administrative Expenses: General and administrative expenses were
Net Loss: Net loss for the third quarter of 2022 was
Cash Position: Cash and cash equivalents as of
Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(amounts are unaudited)
THREE MONTHS ENDED | NINE MONTHS ENDED | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Research and development service revenue, related party | $ | 31 | $ | 31 | $ | 94 | $ | 94 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 5,376 | 5,265 | 15,815 | 11,324 | ||||||||||||
General and administrative | 3,536 | 2,795 | 10,900 | 6,756 | ||||||||||||
Total operating expenses | 8,912 | 8,060 | 26,715 | 18,080 | ||||||||||||
Loss from operations | (8,881 | ) | (8,029 | ) | (26,621 | ) | (17,986 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Grant income | — | 131 | — | 927 | ||||||||||||
Interest, dividend and investment income (expense), net | (176 | ) | (14 | ) | (716 | ) | (42 | ) | ||||||||
Change in fair value of warrant liability | 369 | (8,250 | ) | 13,626 | (20,619 | ) | ||||||||||
Total other income (expense), net | 193 | (8,133 | ) | 12,910 | (19,734 | ) | ||||||||||
Net loss | $ | (8,688 | ) | $ | (16,162 | ) | $ | (13,711 | ) | $ | (37,720 | ) | ||||
Net loss per share, basic and diluted | $ | (0.30 | ) | $ | (0.69 | ) | $ | (0.48 | ) | $ | (2.42 | ) | ||||
Weighted-average common shares outstanding, basic and diluted | 28,891,909 | 23,325,716 | 28,798,284 | 15,579,267 | ||||||||||||
Consolidated Balance Sheet Data
(in thousands)
(amounts are unaudited)
2022 | 2021 | |||||||
Cash and cash equivalents | $ | 77,183 | $ | 82,642 | ||||
Working capital (1) | 73,172 | 79,583 | ||||||
Total assets | 85,007 | 89,205 | ||||||
Warrant liability | 4,626 | 18,252 | ||||||
Total other liabilities | 28,254 | 6,816 | ||||||
Accumulated deficit | (94,006 | ) | (80,295 | ) | ||||
Total stockholders equity | $ | 52,127 | $ | 64,137 | ||||
(1) Working capital is calculated as current assets less current liabilities | ||||||||
About
Candel is a clinical stage biopharmaceutical company focused on helping patients fight cancer with viral immunotherapies that elicit a systemic anti-tumor immune response. Candel’s engineered viruses are designed to induce immunogenic cell death through direct viral-mediated cytotoxicity in cancer cells, thus releasing tumor neo-antigens while creating a pro-inflammatory microenvironment at the site of injection. Candel has established two clinical stage viral immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and CAN-3110 is the lead product candidate from the HSV platform. The enLIGHTEN™ Discovery Platform is the first systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors.
For more information about Candel, visit www.candeltx.com.
Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of development programs, including key data readout milestones and indications; expectations regarding the therapeutic benefit of its programs; and expectations regarding cash runway and expenditures. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, and strategic plans for the Company’s business and product candidates, and other risks identified in the Company’s
Media Contact
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