CoLucid Pharmaceuticals, Inc. (NASDAQ:CLCD) today reported financial and operating results for the quarter ended September 30, 2016.
In September 2016 CoLucid announced that it had completed its first pivotal Phase 3 clinical trial of lasmiditan oral tablets, SAMURAI, which was a randomized, double-blind, placebo-controlled parallel group study designed to evaluate the efficacy and safety of lasmiditan (100 mg and 200 mg) in comparison to placebo. Both the 100 mg and 200 mg doses of lasmiditan were efficacious on migraine headache pain freedom, the primary endpoint, and most bothersome associated symptom freedom, the key secondary endpoint, at the two-hour time point (p < 0.001). Both the primary and key secondary endpoints of SAMURAI conform to the U.S. Food and Drug Administration’s (“FDA”) draft Guidance for Industry, Migraine: Developing Drugs for Acute Treatment, issued in October 2014. Both the 100 mg and 200 mg doses of lasmiditan were also more efficacious than placebo on headache pain relief at the two-hour time point (p < 0.001), as a rescue medication on headache pain freedom at the two-hour time point (p < 0.001 and p < 0.012), in reducing migraine related disability at the two-hour time point (p < 0.001) and in improving Patient Global Impression of Change (p < 0.001). Lasmiditan was well tolerated with no significant difference in cardiovascular adverse events in patients dosed with lasmiditan versus placebo. SAMURAI is the first of two Phase 3 pivotal trials of lasmiditan, each being conducted under a Special Protocol Assessment (“SPA”) – agreement with the FDA.
At the 5th European Headache and Migraine Trust International Congress (“EHMTIC”) in September 2016, an interim update on CoLucid’s Phase 3 long-term, open-label trial evaluating lasmiditan, the GLADIATOR study was also presented by Dr. Uwe Reuter, Department of Neurology and Director of the Headache Center, Charité Universitätsmedizin Berlin. Migraine patients who have completed SAMURAI, as well as CoLucid’s second Phase 3 pivotal trial, SPARTAN, have been eligible to enroll in GLADIATOR. GLADIATOR is expected to enroll up to a total of 2,580 patients, who will be randomized to receive 100 mg or 200 mg of lasmiditan, and treat up to eight migraine attacks per month for one year.
For a more complete discussion of the SAMURAI trial results, including discussion of treatment emergent adverse events and study design as well as the full EHMTIC symposium presentations for SAMURAI and GLADIATOR see http://investor.colucid.com.
On September 14, 2016 the Company closed a follow-on public offering of shares of its common stock which resulted in the sale of 3,737,500 shares of common stock at a price to the public of $20.00 per share. The aggregate net proceeds received by the Company from the offering were approximately $69.9 million, net of underwriting discounts and commissions of approximately $4.6 million and approximately $0.3 million of offering expenses paid by the Company.
“This quarter was transformative for CoLucid as SAMURAI demonstrated that lasmiditan oral tablets, either 100 mg or 200 mg, may become an important acute treatment for migraine,” said Thomas P. Mathers, Chief Executive Officer. “Given that in SAMURAI, lasmiditan demonstrated efficacy as a primary treatment, successfully met the secondary endpoint as a rescue medication, and was well tolerated even in a patient demographic rich with cardiovascular risk factors and conditions, we are very encouraged by the prospects of potentially offering migraine patients the first new mechanism of action for acutely treating their migraines in over twenty years. We believe our recently completed follow-on public offering has afforded us the necessary capital to potentially submit a New Drug Application (“NDA”) to the FDA for lasmiditan in the first half of 2018, pending the outcome of our SPARTAN Phase 3 clinical trial and other necessary development activities.”
2016 Financial Results
The Company ended the third quarter of 2016 with cash, cash equivalents, and investments of $100.2 million compared to $64.5 million at year-end 2015. The increase was due to the follow-on public offering of 3.7 million shares of CoLucid common stock which was completed in the third quarter of 2016 and generated approximately $69.9 million in net proceeds to the Company. The Company believes it has sufficient cash, cash equivalents and available for sale securities to enable it to fund the remainder of SPARTAN, a substantial portion of GLADIATOR, and the submission of an NDA to the FDA for lasmiditan. The Company also estimates that such funds will support its operating expenses and capital expenditure requirements through at least the second quarter of 2018.
Research and development expenses were approximately $10.5 million in the third quarter of 2016 compared to $5.8 million for the third quarter of 2015. The increase in R&D expense was primarily due to the increased costs associated with the lasmiditan Phase 3 clinical program including GLADIATOR, which began enrollment in October 2015 and SPARTAN which began enrollment in May 2016.
General and administrative expenses were approximately $2.2 million in the third quarter of 2016 compared to $3.2 million for the third quarter of 2015. The decrease in G&A expense is due to a $1.2 million reduction in stock compensation expense between the two periods.
Net loss attributable to common stockholders for the third quarter of 2016 was $12.7 million, or $0.79 per share, compared to $8.9 million, or $0.59 per share, for the third quarter of 2015.
Lasmiditan has been designed for the acute treatment of migraine headaches in adults without the vasoconstrictor activity associated with previous generations of migraine therapies. It selectively targets 5-HT1F receptors expressed in the trigeminal pathway. Lasmiditan has been given the generic stem name “ditan,” which distinguishes it from other drug classes, including triptans, the current standard of care for migraine.
CoLucid is currently enrolling patients in a second pivotal Phase 3 clinical trial of lasmiditan oral tablets, SPARTAN. The objective of SPARTAN is to evaluate the safety and efficacy of lasmiditan (50 mg, 100 mg and 200 mg) in comparison to placebo two hours after dosing on freedom from migraine headache pain, which is the primary endpoint, and on freedom from the most bothersome associated symptom of migraine (nausea, phonophobia or photophobia), which is the key secondary endpoint. SPARTAN is a randomized, double-blind, placebo-controlled parallel group study. The study is expected to treat a single migraine in up to 2,226 migraine patients with lasmiditan at approximately 140 sites in the United States, United Kingdom and Germany. CoLucid expects that migraine patients enrolled in SPARTAN will include those who also have one or more cardiovascular risk factors, stable cardiovascular disease or known coronary artery disease (“CAD”). CoLucid has obtained an SPA agreement from the FDA for SPARTAN. Top-line results from SPARTAN are expected in the second half of 2017.
CoLucid is also currently enrolling patients in GLADIATOR, a Phase 3 long-term, open-label trial of lasmiditan. GLADIATOR’s objective is to evaluate the safety and efficacy of lasmiditan, (both the 100 mg and 200 mg dose) as well as resource utilization, functional outcomes and disability. Based on the results of GLADIATOR, CoLucid intends to build an appropriate safety database to support an NDA for lasmiditan. At the time of the NDA submission, it is anticipated that there will be more than 15,000 patient exposures to lasmiditan in the entire clinical program.
Migraine is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation. An estimated 36 million Americans suffer from migraine. Migraine can be extremely disabling and costly, accounting for more than an estimated $20 billion in direct (e.g., doctor visits, medications) and indirect (e.g., missed work, lost productivity) expenses each year in the United States.
About CoLucid Pharmaceuticals, Inc.
CoLucid is developing oral lasmiditan for the acute treatment of migraine headaches in adults and intravenous lasmiditan for the acute treatment of headache pain associated with migraine in adults in emergency room and other urgent care settings.