On May 12, 2022 KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a specialty pharmaceutical company focused on the discovery, development and commercialization of novel treatments for rare central nervous system (CNS) and neurodegenerative diseases, reported its financial results for the first quarter ended March 31, 2022 (Press release, KemPharm, MAY 12, 2022, View Source [SID1234614530]).
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"KemPharm continued to make significant progress during the first quarter of 2022 and recent weeks, in particular taking several important steps to further the clinical development of our SDX-based drug candidates led by KP1077," stated Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm. "In keeping with our strategic focus on developing and commercializing therapeutics for rare CNS and neurodegenerative conditions, we filed an IND with the FDA seeking permission to commence a clinical program to evaluate KP1077 for IH, a rare sleep disorder with limited treatment options. Upon clearance of the IND, we plan to initiate a Phase 2 clinical trial of KP1077 for IH (KP1077.D01) as early as the second half of 2022, with a second trial in narcolepsy targeted to begin the quarter following the start of KP1077.D01."
Dr. Mickle continued, "We believe there is great potential for KP1077 and other SDX-based treatments in IH and the broader rare sleep disorder market. Stimulant-based drugs currently in use come with significant limitations, including cardiovascular side effects, such as elevated blood pressure which results in many of these treatments being contraindicated for many IH patients. Understanding this, we initiated a Phase 1 trial last month comparing the cardiovascular safety of SDX to immediate-release and long-acting formulations of Ritalin, a commonly prescribed CNS stimulant. We believe that demonstrating an improved cardiovascular safety profile compared to current stimulants is a key potential differentiator for KP1077. This benefit could allow SDX to be dosed at higher levels than current treatments which should provide improved efficacy when compared to other off-label stimulant-based medications."
Dr. Mickle continued, "We are also excited by the growing momentum behind the national commercialization of AZSTARYS by Corium. Payor access continues to expand with 110 million commercial lives now covered and prescription volumes continue to grow as well. More than 2,600 pharmacies have dispensed AZSTARYS, and it is listed on formularies by two of the three largest PBMs in the U.S. We look forward to watching the progress of AZSTARYS as our partners at Corium continue the U.S. launch."
Dr. Mickle concluded, "On the business development front, we continue to pursue our goal of acquiring or licensing complimentary clinical-stage assets in rare CNS and neurodegenerative diseases where we can leverage our existing clinical development and regulatory expertise. Internally, we are advancing several early-stage candidates and hope to announce a potential addition to our development pipeline as soon as this quarter. Supporting our strategic and pipeline development efforts is a strong financial foundation, bolstered by $119.1 million in cash, cash equivalents, marketable securities and long-term investments as of March 31, 2022."
Q1 2022 Financial Results:
KemPharm’s revenue for Q1 2022 was $4.0 million, as compared to Q1 2021 revenue of $12.1 million.
Research and development expenses were $3.1 million for Q1 2022, as compared to $2.3 million in Q1 2021, driven primarily by the initiation of the KP1077 clinical development program.
General and administrative expenses were $2.7 million for Q1 2022, as compared to $1.9 million in Q1 2021. The period-over-period increase was primarily driven by increased compensation costs, including non-cash stock-based compensation, and an increase in professional fees associated with commercial and strategic planning.
Net loss attributable to common stockholders for Q1 2022 was ($1.9) million, or ($0.05) per basic and diluted share, compared to a net loss attributable to common stockholders of ($47.7) million, or ($2.49) per basic and diluted share for the same period in 2021. Net loss for Q1 2022 was driven primarily by a loss from operations of ($1.9) million and net interest and other loss of ($0.2) million, partially offset by non-cash fair value adjustment income related to derivative and warrant liability of $0.2 million.
As of March 31, 2022, total cash, cash equivalents, marketable securities and long-term investments was $119.1 million, which was a decrease of $8.7 million compared to $127.8 million as of December 31, 2021, driven in part by $4.7 million of repurchases of common stock during the period and increased spending on third-party research and development costs related to the KP1077 clinical trial program. Based on the Company’s current operating forecast, existing cash, cash equivalents, marketable securities and long-term investments are expected to be sufficient to continue operations through and beyond 2025.
Conference Call Information:
KemPharm will host a conference call and live audio webcast with a slide presentation today at 5:00 p.m. ET, to discuss its corporate and financial results for the first quarter of 2022.