CNS Pharmaceuticals regains Nasdaq bid price compliance, faces one-year monitor

The Nasdaq letter

CNS Pharmaceuticals, Inc. (Nasdaq: CNSP) said in an 8-K dated March 31, 2025 that Nasdaq had notified it that it had regained compliance with the bid price rule for The Nasdaq Capital Market.

The rule, Nasdaq Listing Rule 5550(a)(2), requires a closing bid price of at least $1.00 per share. Nasdaq staff wrote to the company on September 12, 2024, saying its common stock had not held a closing bid price of $1.00 for the previous 30 consecutive business days.

Why there was no cure period

Normally a company gets a 180-calendar day period to fix a bid price problem. CNS was not eligible for any compliance period under Listing Rule 5810(c)(3)(A)(iv), because it had carried out one or more reverse stock splits over the prior two years with a cumulative ratio of 250 shares or more to one. The 8-K does not give the dates or ratios of those splits.

Instead, Nasdaq gave the company a temporary exception on October 30, 2024, to regain compliance by March 11, 2025. The 8-K does not say on what date the company regained compliance, only that the confirming letter came on March 31, 2025, after that deadline.

The one-year monitor

CNS is now subject to a Mandatory Panel Monitor for one year from the date of the letter, under Listing Rule 5815(d)(4)(B). If staff finds the company out of compliance with the same bid price rule again during that year, the company cannot submit a plan of compliance for that deficiency, and no extra time or cure period applies. Staff would instead issue a delist determination letter, and the company could request a new hearing.

The 8-K does not say what the company plans to do to keep its bid price above $1.00.

The business behind the listing

The 10-K filed the same day describes CNS as a clinical pharmaceutical company organized as a Nevada corporation in July 2017, developing anti-cancer drugs for brain and central nervous system tumors. Its two lead candidates are TPI 287, an abeotaxane, and Berubicin, an anthracycline. Both are aimed at glioblastoma.

TPI 287 has orphan drug designation from the FDA, which the company says may enable 7 years of market exclusivity after approval. The 10-K says it has been studied in Phase I and II trials involving over 300 patients, yet concedes it has shown promise only in limited clinical trials and that further development is needed to determine its future in neuro-oncology.

Berubicin was discovered at The University of Texas M.D. Anderson Cancer Center by Dr. Waldemar Priebe, the company's founder. It was first licensed to Reata Pharmaceuticals, which started several Phase I trials and then let its IND lapse for strategic reasons. CNS obtained a new IND, which the company announced on December 17, 2020 was in effect.

The Berubicin trial

The trial compares Berubicin with lomustine, which the 10-K calls a current standard of care in this setting. It randomizes 252 patients with glioblastoma who have failed primary treatment, 2 to 1. Berubicin is given as a 2-hour IV infusion of 7.5 mg/m2 daily for three consecutive days, then 18 days off, in a 21-day cycle. Lomustine is taken orally once every six weeks.

The primary endpoint is overall survival. The company says the FDA has recognized that endpoint as a basis for approving oncology drugs when a statistically significant improvement is shown against a randomized control arm.

The trial design included a pre-planned, non-binding interim futility analysis, which the independent Data Safety Monitoring Board was responsible for conducting. The board's charter had it review overall survival, secondary endpoints and safety data. On March 25, 2025, the company released topline data from the primary analysis of the trial.

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