On November 10, 2022 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on helping patients fight cancer with viral immunotherapies, reported financial results for the third quarter ended September 30, 2022 and provided a corporate update (Press release, Candel Therapeutics, NOV 10, 2022, View Source [SID1234623667]).
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"Candel made important progress across multiple facets of the organization this quarter," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "We have bolstered the Company’s capabilities and future potential with the appointment of three new board members and two new leadership executives, an orphan drug designation from the European Commission for CAN-2409 in glioma, and most recently a discovery partnership with the University of Pennsylvania’s Center for Cellular Immunotherapies, led by Dr. Carl June, the Richard W. Vague Professor for Immunotherapy, to study the combination of our enLIGHTEN Discovery Platform and their CAR-T cells in solid tumors. We will close the year with new clinical results coming from our pipeline being presented at R&D Day and we look ahead with confidence to deliver our world-class viral immunotherapy candidates to patients battling cancer."
Jason A. Amello, Chief Financial Officer, added, "The third quarter of 2022 was marked by significant momentum as the Company broadened its viral immunotherapy footprint and continued to execute across all of its programs in an efficient and cost-effective manner."
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 Corporation
Gary Nabel, MD, PhD, Chief Innovation Officer of OPKO and Chief Executive Officer, ModeX Therapeutics, Inc., an OPKO Health company
Renee 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 and Garrett 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 the T Cell Engineering Lab at the University of Pennsylvania’s Center 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 with Credit Suisse and BMO Capital Markets. (View Webcasts)
Key Upcoming Milestones and Events
37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (View Release)
On November 11, Anne R. Diers, PhD, Director of Early 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 from Dana-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 November 16, Dr. Tak will take part in an in-person fireside chat at Jefferies 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 by Alexander Ling, PhD, a Postdoctoral Research Fellow from Brigham and Women’s Hospital.
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 September 30, 2022
Research and Development Service Revenue, related party: Research and Development Service Revenue, related party, for the third quarters ended September 30, 2022 and 2021 was $31,000.
Research and Development Expenses: Research and development expenses were $5.4 million for the quarter ended September 30, 2022 compared to $5.3 million for the comparable period in 2021. The increase was primarily due to personnel-related costs for additional headcount, as well as operating expenses related to the conduct of five ongoing clinical studies. Research and development expenses includes non-cash stock compensation expense of $343,000 and $1.5 million for the third quarter of 2022 and 2021, respectively.
General and Administrative Expenses: General and administrative expenses were $3.5 million for the third quarter of 2022 compared to $2.8 million for the third quarter of 2021. The increase was primarily due to higher recruiting costs, personnel-related costs, and professional and consulting fees associated with operating as a public company. General and administrative expenses includes non-cash stock compensation expense of $400,000 and $390,000 for the third quarter of 2022 and 2021, respectively.
Net Loss: Net loss for the third quarter of 2022 was $8.7 million compared to $16.2 million for the comparable period of 2021. The net loss for the third quarter of 2022 includes non-operating interest, dividend and investment expense of $176,000 and a non-cash credit of $369,000 for the change in the fair value of the Company’s warrant liability. The net loss for the third quarter
of 2021 includes net non-operating income of $117,000 and a non-cash charge of $8.3 million for the change in the fair value of the Company’s warrant liability.
Cash Position: Cash and cash equivalents as of September 30, 2022 were $77.2 million compared to $82.6 million as of December 31, 2021, and reflects the receipt of $20.0 million from the term loan with Silicon Valley Bank in February 2022. Based on current plans and assumptions, the Company expects that its existing cash and cash equivalents will be sufficient to fund its current operating plan into the first quarter of 2024.