What Cardiff Oncology, Inc. told the SEC could break it.

Cardiff's corporate headquarters and principal operations are in San Diego, California, an area prone to wildfires and earthquakes, where a natural disaster or power outage could severely disrupt operations.

“Our corporate headquarters are located in San Diego, California, an area prone to wildfires and earthquakes.”

Executive orders directing HHS to modify the Medicare Drug Price Negotiation Program, implement payment models to cut high-cost drug prices, and facilitate drug importation could constrain future pricing and reimbursement for onvansertib if approved.

“an executive order was signed directing the Secretary of HHS to take appropriate steps to, among other things, modify certain provisions of the Medicare Drug Price Negotiation Program, develop and implement a payment model to reduce the price of high-cost prescription drugs and biological products covered by Medicare, accelerate approval of generic and biosimilar products, and facilitate the ability of states to import pharmaceuticals from other countries”

Cardiff relies entirely on third-party manufacturers and distributors to supply and distribute onvansertib for its clinical and nonclinical programs, with no in-house manufacturing, exposing it to supply interruption risk.

“We currently rely on third-party manufacturers and distributors to supply and distribute onvansertib used in our clinical studies and nonclinical development programs.”

Cardiff has experienced negative cash flow developing its single lead candidate onvansertib (net losses ~$45.9M), generates only limited revenue, and expects substantial continuing losses, making it dependent on external financing.

“we have experienced negative cash flow from development of our product candidate, onvansertib. We have generated limited revenue from operations, and we expect to incur substantial net losses for the foreseeable future as we seek to further develop and commercialize onvansertib.”