KemPharm, Inc. (NASDAQ:KMPH) Files An 8-K Regulation FD Disclosure

KemPharm, Inc. (NASDAQ:KMPH) Files An 8-K Regulation FD Disclosure
Item 7.01 and contained in the press release furnished as Exhibit 99.1 and in the presentation furnished as Exhibit 99.2shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and is not incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Securities Act, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.

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Item 8.01 Other Events.

In the press release described above, onJuly 9, 2018, the Company announced top line results from a pivotal efficacy and safety clinicaltrial of KP415, or KP415.E01. Results from KP415.E01 indicated that KP415 successfully met the primary efficacy endpoint in patients with ADHD between the ages of 6 and 12 years. KP415.E01was a multicenter, randomized, parallel, double-blind, placebo-controlled analog laboratory classroom clinical trial in 150 children aged 6-12 years old with a diagnosis of ADHD to assess the efficacy and safety of KP415. Subjects who received KP415 met the trial’s primary and secondary efficacy endpoint, showing statistically significant improvement on both the Swanson, Kotkin, Agler, M-Flynn, and Pelham, or SKAMP,Scale and the Permanent Product Measure of Performance, or PERMP, scale.

The KP415 capsules contain two active pharmaceutical ingredients: d-MPH hydrochloride as the immediate release, or IR, d-MPH component, and serdexmethylphenidate, or SDX, a prodrug of d-MPH that provides the extended duration component. In terms of d-MPH equivalent amounts, all capsule strengths contain 30% of d-MPH (IR component) and 70% of d-MPH from SDX. Subjects in this trial received daily oral doses (1 capsule/day) of either 28/6 mg SDX/d-MPH, 42/9 mg SDX/d-MPH, or 56/12 mg SDX/d-MPH, corresponding to equivalent d-MPH amounts of 20, 30 and 40 mg, respectively. The dose of KP415 was optimized during a 3-week dose optimization phase with open-label KP415 capsules. After completion of the dose optimization period, subjects were randomized to 7 days of double-blind treatment with their optimized dose of KP415 or matching placebo.

The efficacy evaluation was based on SKAMP and PERMP scores pre-dose, and at 0.5, 1, 2, 4, 8, 10, 12 and 13 hours post-dose during a full laboratory classroom day at Visit 6 (at the end of the seven-day treatment period). The baseline SKAMP score was measured pre-dose at Visit 5 (immediately prior to randomization and the first dose in the seven-day treatment period) due to potential concerns of carryover of methylphenidate into the Visit 6 classroom day which would have disadvantaged KP415, as well as an assumption that placebo would not significantly change from Visit 5 to Visit 6. A post-hoc analysis was conducted using the baseline SKAMP scores measured at pre-dose Visit 6. The SKAMP is a validated rating of classroom behaviors in children with ADHD; the PERMP is an adjusted math test designed to assess attention in children with ADHD through a subject’s ability to initiate, self-monitor, and complete the test.

The study met the primary endpoint of mean SKAMP-Combined, or SKAMP-C,change from baseline score (pre-dose Visit 5 as baseline) across all post-dose time points (Visit 6): The least-squares mean post-dose SKAMP-C difference from baseline (150 subjects) was higher for placebo than for KP415 (0.54 vs. -4.87, respectively; p<0.001), indicating fewer ADHD symptoms with KP415 therapy than with placebo.

Using pre-dose Visit 5 as baseline (pre-specified), the SKAMP-C change from baseline was statistically significantly better (p<0.001) with KP415 versus placebo from 1–10 hours post-dose; using pre-dose Visit 6 as baseline (post-hoc), the SKAMP-C change from baseline was statistically significantly better (p<0.01) with KP415 versus placebo from 0.5–13 hours post-dose.

The PERMP-Attempted and PERMP-Correct scores (secondary endpoints) support the primary endpoint conclusion overall (mean changes; p<0.01) and showed statistically significantly better performance with KP415 versus placebo at each time point from 0.5-13 hours (p<0.05).

The observed adverse events were mild to moderate in severity and were typical of those seen in other stimulant trials. No serious adverse events were reported.

The information contained in this Current Report on Form 8-K speaks only as the date hereof. While the Company may elect to update the information in this Current Report on Form 8-K in the future, the Company disclaims any obligation to do so except to the extent required by applicable law.

Caution Concerning Forward Looking Statements

ThisCurrent Report on Form 8-Kmay contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act and Section 21E of the Exchange Act. Forward-looking statements include all statements that do not relate solely to historical or current facts, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. These forward-looking statements include statements regarding the expected features and characteristics of the Company’s product candidates, including KP415, as well as the expected timing of the completion of clinical trials or studies related to KP415 and the expected timing of the NDA submission for KP415. These forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available tothe Companyand its current plans or expectations, and are subject to a number of uncertainties and risks that could significantly affect current plans. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: the Company's financial resources and whether they will be sufficient to meet the Company's business objectives and operational requirements; results of earlier studies and trials may not be predictive of future clinical trial results; the protection and market exclusivity provided by the Company's intellectual property; risks related to the drug discovery and the regulatory approval process; the impact of competitive products and technological changes; and the FDA approval process under the Section 505(b)(2) regulatory pathway, including without limitation any timelines for related approval. The Company's forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning the Company’s business are described in additional detail in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, filed with the Securities and Exchange Commission on May 11, 2018, and the Company’s other Periodic and Current Reports filed with the Securities and Exchange Commission.The Companyis under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

Item 9.01 Financial Statements and Exhibits.


KEMPHARM, INC Exhibit
EX-99.1 2 ex_117455.htm EXHIBIT 99.1 ex99-1.htm Exhibit 99.1     KemPharm Announces Top Line Results from KP415.E01 Efficacy and Safety Trial in Children With ADHD   Results from Single Classroom-Style Trial Met Pre-Specified Primary and Secondary Endpoints   Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today at 8:00 a.m. ET   Coralville,…
To view the full exhibit click here

About KemPharm, Inc. (NASDAQ:KMPH)

KemPharm, Inc. is a clinical-stage specialty pharmaceutical company. The Company is engaged in the discovery and development of prodrugs. The Company uses its Ligand Activated Therapy (LAT) platform technology to create prodrugs. The Company’s product candidate, KP201/APAP, consists of KP201, its prodrug of hydrocodone, which is combined with acetaminophen (APAP). The Company is developing KP201/APAP as an immediate release (IR), a product candidate for the short-term, or no longer than 14 days for the management of acute pain. The Company has designed KP201/APAP with abuse-deterrent properties to address the epidemic of opioid abuse in the United States. The Company also focuses on developing the pipeline of additional prodrug product candidates that targets pain and attention deficit hyperactivity disorder (ADHD). The Company’s products include KP201/IR (APAP-free), KP511/ER, KP415, KP606/IR and KP746.

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