On May 12, 2022 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a late clinical stage biopharmaceutical company focused on helping patients fight cancer with oncolytic viral immunotherapies, reported financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, Candel Therapeutics, MAY 12, 2022, View Source [SID1234614282]).
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"2022 is off to a great start as we continue to advance our late-stage pipeline of novel oncolytic viral immunotherapies for cancer," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "Today, we are well positioned for major catalysts over the next 12 months, namely multiple clinical data readouts across our product candidates and advancement of our pipeline of promising therapeutics with potential to treat various solid tumors including lung, brain, pancreatic and prostate cancer. We look forward to delivering on our mission to develop oncolytic viral immunotherapies aimed at tipping the balance in favor of the patient’s immune system to fight cancer."
First Quarter 2022 & Recent Highlights
•Enhanced executive leadership with the promotion of Francesca Barone, MD, PhD to Chief Scientific Officer and appointment of Seshu Tyagarajan, PhD, RAC as Chief Technical and Development Officer.
•Strengthened cash position with a $20.0 million non-dilutive debt financing with Silicon Valley Bank (SVB) in February 2022.
Key Upcoming Milestones
•To present initial data from an ongoing Phase 2 clinical trial of CAN-2409 and valacyclovir combined with PD-1 or PD-L1 targeting agents in patients with stage III/IV non-small cell lung cancer at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held in-person June 3-7, 2022 at the McCormick Place Convention Center in Chicago, Illinois.
•In the fourth quarter of 2022, the Company expects to present data from two high grade glioma clinical trials – a Phase 1b clinical trial of CAN-2409 in combination with
nivolumab (Opdivo) combined with standard of care first line treatment and a Phase 1 clinical trial of CAN-3110 in recurrent high-grade glioma.
Financial Results for the Quarter Ended March 31, 2022
Cash Position: Cash and cash equivalents as of March 31, 2022 were $94.3 million compared to $82.6 million as of December 31, 2021. The net increase was due to receipt of $20.0 million from a term loan with SVB and the use of $8.0 million in cash to fund operating activities. Based on current plans and assumptions, the Company expects that its existing cash and cash equivalents will be sufficient to fund its operations into the fourth quarter of 2023.
Research and Development Expenses: Research and development expenses were $5.4 million for the three-month period ended March 31, 2022 compared to $2.8 million for the comparable period in 2021. The increase was primarily due to increased personnel-related costs, including stock-based compensation, for additional headcount to support the ongoing clinical trials for Candel’s product candidates and $1.0 million of severance in the first quarter of 2022, as well as increased clinical development costs related to our clinical trial sites and the cost of treatment and follow-up on patients. Excluding stock-based compensation expense of $142,000 for the three-month period ended March 31, 2022, research and development expenses for the three-month period ended March 31, 2022 were $5.3 million.
General and Administrative Expenses: General and administrative expenses were $3.6 million for the three-month period ended March 31, 2022 compared to $1.9 million for the comparable period in 2021. The increase was primarily due to increased insurance costs, personnel-related costs including stock-based compensation for additional headcount required to support the growth of the Company and operate as a public company, and professional and consulting fees associated with public relations consultants, legal firms, and accounting firms associated with operating as a public company. Excluding stock-based compensation expense of $350,000 for the three-month period ended March 31, 2022, general and administrative expenses for the three-month period ended March 31, 2022 were $3.3 million.
Total Operating Expenses: Total operating expenses were $9.0 million for the three-month period ended March 31, 2022 compared to $4.7 million for the comparable period in 2021.The increase was primarily due to increased personnel-related costs including stock-based compensation for additional headcount required to support the growth of the Company and to operate as a public company, severance costs, insurance costs, and professional and consulting fees associated with operating as a public company. Excluding stock-based compensation expense of $492,000 for the three-month period ended March 31, 2022, total operating expenses for the three-month period ended March 31, 2022, were $8.5 million.
Net Loss: Net loss was $874,000 for the three-month period ended March 31, 2022 compared to a net loss of $4.5 million for the comparable period in 2021. The net loss for the three-month period ended March 31, 2022 includes a non-cash credit of $8.3 million for the change in the fair value of the Company’s warrant liability and stock-based compensation expense of $492,000. Excluding the non-cash credit for the change in the warrant liability and the charge for stock-based compensation, the net loss for the three-month period ended March 31, 2022 was $8.7 million.