KemPharm, Inc. Reports Second Quarter 2018 Results
Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today at
- Announced top line results from KP415.E01 efficacy and safety trial in children with ADHD
- Announced top line results from intravenous human abuse potential trial with KP415 Prodrug (KP415.A03)
- Net loss of
$0.65per basic share and $0.91per diluted share for the quarter ended June 30, 2018, compared to net loss of $0.44per basic and diluted share for the quarter ended June 30, 2017
- Total cash and security-related amounts were
$29.3 millionat June 30, 2018
“The second quarter was highlighted by important advances involving our ADHD prodrug portfolio and our co-lead product candidate, KP415, including top line data from the efficacy and safety trial of KP415 (KP415.E01) and top line data from the intravenous (KP415.A03) human abuse potential trial with our KP415 prodrug (serdexmethylphenidate),” said
“We believe the results from these two studies suggest that KP415 offers the potential to be a differentiated methylphenidate product that is able to address key unmet needs in ADHD treatment, including early onset of action, duration of therapy and lower abuse potential,” Mickle continued. “With these milestones achieved, and with data forthcoming from the oral and intranasal human abuse potential studies of serdexmethylphenidate, we remain well positioned to file a potential New Drug Application (NDA) for KP415 in early 2019.”
Q2 2018 Financial Results:
For the quarter ended
Conference Call Information:
- (866) 395-2480 (U.S.)
- (678) 509-7538 (international)
- Conference ID: 5597261
An audio webcast with slide presentation will be accessible via the Investor Relations section of the
Recent and Q2 2018 Activities:
- Announced Top Line Results from KP415.E01 Efficacy and Safety Trial in Children With ADHD
July 9, 2018, KemPharmannounced top line results from a pivotal efficacy and safety clinical trial of KP415. Results from the trial (KP415.E01) indicated that KP415 successfully met the primary efficacy endpoint in patients with attention deficit/hyperactivity disorder (ADHD) between the ages of 6 and 12 years. The trial was 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 endpoints, showing statistically significant improvement on both the Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP) and the Permanent Product Measure of Performance (PERMP) scale.
- Announced Topline Results from an Intravenous Human Abuse Potential Trial with KP415 Prodrug
May 10, 2018, KemPharmannounced topline results from the first of three human abuse potential trials to be conducted with the prodrug contained in both KP415 and KP484 (serdexmethylphenidate). This single-center study (KP415.A03) was designed to measure the pharmacokinetics and pharmacodynamic effects of serdexmethylphenidate, d-methylphenidate hydrochloride and placebo after intravenous (IV) administration in recreational stimulant users. Serdexmethylphenidate and d-methylphenidate hydrochloride were dosed at equimolar (equivalent) levels. Serdexmethylphenidate demonstrated statistically significant differences compared to d-methylphenidate hydrochloride in the primary endpoint, maximal Drug Liking (Emax), and no statistical difference compared to placebo. Secondary endpoints including Emax of Overall Drug Liking, Feeling High, and Good Effects were also significantly reduced for serdexmethylphenidate compared to d-methylphenidate hydrochloride, and similar for serdexmethylphenidate compared to placebo. Additionally, Emax of Take Drug Again was statistically lower for serdexmethylphenidate compared to d-methylphenidate hydrochloride. Collectively, these findings indicate that IV administration of the serdexmethylphenidate resulted in effects that were statistically similar to placebo as measured by multiple endpoints that are commonly used to assess human abuse potential.
APADAZ was developed from KemPharm’s proprietary LAT platform technology and is intended for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
The approval of APADAZ via the 505(b)(2) pathway was based in part on pharmacokinetic studies with Vicoprofen®, Ultracet®, and Norco® in which APADAZ demonstrated exposure to hydrocodone and acetaminophen (APAP) that is expected to result in therapeutic effects equivalent to currently approved immediate-release hydrocodone/APAP combination products when administered orally as intended.
APADAZ contains an opioid agonist and acetaminophen and is indicated for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use:
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve APADAZ for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] have not been or are not expected tolerated, or have not provided adequate analgesia, or are not expected to provide adequate analgesia.
Important Safety Information:
APADAZ is contraindicated in patients with: significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment; known or suspected gastrointestinal obstruction, including paralytic ileus; and hypersensitivity to hydrocodone or acetaminophen.
APADAZ contains benzhydrocodone, a Schedule II controlled substance. APADAZ can be abused and is subject to misuse, addiction, and criminal diversion.
Potential risks associated with APADAZ include addiction, abuse, and misuse, life-threatening respiratory depression, neonatal opioid withdrawal syndrome, risks of concomitant use or discontinuation of cytochrome P450 CYP3A4 inhibitors and inducers, acetaminophen hepatoxicity risks from concomitant use with benzodiazepines or other central nervous system (CNS) depressants, risk of life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients, adrenal insufficiency, severe hypotension, serious skin reactions, risks of use in patients with increased intracranial pressure, brain tumors, head injury, or impaired consciousness, hypersensitivity/anaphylaxis, risks of use in patients with gastrointestinal conditions, risk of use in patients with seizure disorders, and withdrawal, risks of driving and operating machinery.
Potential drug interactions with APADAZ include:
- Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue APADAZ if serotonin syndrome is suspected.
- Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with APADAZ because they may reduce analgesic effect of APADAZ or precipitate withdrawal symptoms.
- Monoamine Oxidase Inhibitors (MAOIs): Can potentiate the effects of hydrocodone. Avoid concomitant use in patients receiving MAOIs or within 14 days of stopping treatment with an MAOI.
Most common adverse reactions (>5%) are nausea, somnolence, vomiting, constipation, pruritus, dizziness, and headache.
The Full Prescribing Information for APADAZ contains the following Boxed Warning:
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Addiction, Abuse, and Misuse:
APADAZ exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing APADAZ and monitor all patients regularly for the development of these behaviors and conditions.
Life-Threatening Respiratory Depression:
Serious, life-threatening, or fatal respiratory depression may occur with use of APADAZ. Monitor for respiratory depression, especially during initiation of APADAZ or following a dose increase.
Accidental ingestion of even one dose of APADAZ, especially by children, can result in a fatal overdose of hydrocodone.
Neonatal Opioid Withdrawal Syndrome:
Prolonged use of APADAZ during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Cytochrome P450 3A4 Interaction:
The concomitant use of APADAZ with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Monitor patients receiving APADAZ and any CYP3A4 inhibitor or inducer.
APADAZ contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants:
Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
- Reserve concomitant prescribing of APADAZ and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
- Limit dosages and durations to the minimum required.
- Follow patients for signs and symptoms of respiratory depression and sedation.
For Important Safety Information including full prescribing information, visit: www.kempharm.com
Caution Concerning Forward Looking Statements:
This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. 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. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to
|Investor Contacts:||Media Contact:|
|Jason Rando / Joshua Drumm, Ph.D.
Tiberend Strategic Advisors, Inc.
212-375-2665 / 2664
|Daniel L. Cohen
Executive VP, Government and Public Relations
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
|Three months ended June 30,||Six months ended June 30,|
|Research and development||10,488||4,650||22,125||8,764|
|General and administrative||3,420||3,574||6,552||6,840|
|Total operating expenses||13,908||8,224||28,677||15,604|
|Loss from operations||(13,908||)||(8,224||)||(28,677||)||(15,604||)|
|Other (expense) income:|
|Interest expense related to amortization of debt issuance costs and discount||(390||)||(390||)||(780||)||(780||)|
|Interest expense on principal||(1,419||)||(1,443||)||(2,861||)||(2,884||)|
|Fair value adjustment related to derivative and warrant liability||5,562||3,523||(4,179||)||(3,693||)|
|Interest and other income, net||123||13||238||114|
|Total other (expense) income||3,876||1,703||(7,582||)||(7,243||)|
|Loss before income taxes||(10,032||)||(6,521||)||(36,259||)||(22,847||)|
|Income tax benefit||39||4||47||8|
|Net loss per share:|
|Weighted average number of shares of common stock outstanding:|
CONDENSED BALANCE SHEETS
(in thousands, except share and par value amounts)
|Cash and cash equivalents||$||16,497||$||10,871|
|Trade date receivables||—||2,005|
|Prepaid expenses and other current assets||1,610||1,662|
|Total current assets||30,909||46,996|
|Property and equipment, net||1,841||2,004|
|Other long-term assets||1,250||206|
|Liabilities and stockholders' deficit|
|Accounts payable and accrued expenses||$||13,967||$||7,875|
|Current portion of convertible notes||3,333||3,333|
|Current portion of capital lease obligation||190||189|
|Other current liabilities||113||112|
|Total current liabilities||17,603||11,509|
|Convertible notes, less current portion, net||86,845||89,398|
|Derivative and warrant liability||11,888||7,709|
|Capital lease obligation, less current portion||466||562|
|Other long-term liabilities||743||794|
|Common stock, $0.0001 par value, 250,000,000 shares authorized, 15,905,146 shares issued and outstanding as of June 30, 2018 (unaudited); 14,657,430 shares issued and outstanding as of December 31, 2017||2||1|
|Additional paid-in capital||117,391||107,209|
|Preferred stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued or outstanding as of June 30, 2018 (unaudited) or December 31, 2017||—||—|
|Total stockholders' deficit||(83,545||)||(57,516||)|
|Total liabilities and stockholders' deficit||$||34,000||$||52,456|