KemPharm, Inc. Announces Positive Data From Intranasal Human Abuse Liability Study of KP201/APAP; Reports Q2 2015 Results
Results from First of Two Intranasal Human Abuse Liability Clinical Studies Indicate KP201 Exhibits Significantly Lower Exposure to Hydrocodone When Administered Intranasally
Conference Call and Live Audio Webcast Scheduled for Today at
Recent Clinical Development Highlights:
- Reports positive pharmacokinetic data from first of two KP201 intranasal human abuse liability clinical trials
- Reported positive data from oral human abuse liability clinical trial of KP201/APAP
-
Completed successful KP201/APAP pre-NDA meeting with
FDA - On track to file NDA for KP201/APAP in Q4 2015
Q2 2015 Corporate Highlights:
-
Cash balance at
6/30/2015 was$64.2M , an increase of$54.0M from3/31/2015 -
Named
Gordon K. "Rusty" Johnson to the new role of Chief Business Officer - Promoted R. LaDuane Clifton to Chief Financial Officer
This first intranasal trial (KP201.A03) was conducted with KP201, a prodrug of hydrocodone and the active ingredient ("API") in KP201/APAP. This single-center, cross-over pharmacokinetic study was designed to measure the amount of hydrocodone released from the API, KP201, when insufflated (i.e. snorted) without acetaminophen ("APAP"), as compared directly to hydrocodone bitartrate (HB). KP201 demonstrated a statistically significant lowering in peak hydrocodone exposure (Cmax), and a delay in the time to achieve peak exposure (Tmax), as well as a significant decrease in total exposure to hydrocodone (AUClast and AUC 0-4h) especially in the early time points typically associated with increased drug liking and abuse. Secondary endpoints related to drug liking, pupillometry and ease of snorting also showed significant differences between KP201 and HB with KP201 demonstrating lower drug liking, less pupil dilation and higher difficulty of snorting than HB.
Results from the KP201.A03 trial included:
- 36% decrease in peak hydrocodone exposure (Cmax) for KP201 compared to hydrocodone bitartrate ("HB") when taken intranasally;
- Time to peak hydrocodone exposure (Tmax) delayed by one hour;
- Decreased overall exposure to hydrocodone released from KP201 vs. HB especially in early time points (82% decrease in AUC0-0.5h and 63% decrease in AUC0-1.5h); and
- Significantly lower drug liking and pupil dilation for KP201 as well as a greater difficulty in snorting KP201 vs. HB.
A second intranasal human abuse liability trial (KP201.A02) is currently ongoing and is intended to assess the intranasal abuse potential of the final commercial formulation of KP201/APAP.
Dr. Mickle continued, "The unique attributes of KP201/APAP were also observed in the results of the recently announced KP201.A01 oral human abuse liability trial. Importantly, data from that study indicated that our prodrug technology may offer an improvement in the safety of the drug when taken in high amounts orally, further supporting the potential for Category 2 abuse-deterrent labeling for KP201/APAP."
Dr. Mickle concluded, "Looking ahead, we anticipate reporting data from the remaining studies in our comprehensive KP201/APAP human abuse liability program – the KP201.A02 intranasal human abuse liability trial and three tamper resistance studies – during the third quarter of 2015. Based on reaching these milestones, and the results of our
KP201/APAP Clinical and Regulatory Progress
The KP201.A03 trial is part of a broader human abuse liability program designed by
Remaining components of the human abuse liability program include three nonclinical studies to evaluate the tamper resistance of KP201/APAP (whether the active ingredient can be extracted physically or chemically, abused intravenously or smoked) and a second intranasal human abuse liability clinical trial (KP201.A02) designed to assess the relative pharmacokinetics and drug likability of KP201/APAP compared to Norco®. Results from these studies are expected in the third quarter of 2015.
As announced previously,
Corporate Highlights and Q2 2015 Financial Results
During the second quarter,
Dr. Mickle said, "Creating the role of Chief Business Officer is an exciting milestone for
As of
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About
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 21 E 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. These forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to the Company and 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; and, the impact of competitive products and technological changes. 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
| KEMPHARM, INC. | ||||
| UNAUDITED CONDENSED STATEMENTS OF OPERATIONS | ||||
| (In Thousands, Except Share and Per Share Amounts) | ||||
| Three months ended | Six months ended | |||
| June 30, | June 30, | |||
| 2015 | 2014 | 2015 | 2014 | |
| Revenue | $ — | $ — | $ — | $ — |
| Operating expenses: | ||||
| Research and development | 2,768 | 1,715 | 4,887 | 2,752 |
| General and administrative | 3,188 | 1,330 | 4,165 | 1,864 |
| Total operating expenses | 5,956 | 3,045 | 9,052 | 4,616 |
| Loss from operations | (5,956) | (3,045) | (9,052) | (4,616) |
| Other income (expenses): | ||||
| Gain on extinguishment of debt | — | 1,900 | — | 1,900 |
| Amortization of debt discount | (477) | (159) | (954) | (159) |
| Interest expense | (649) | (704) | (1,280) | (800) |
| Fair value adjustment | (22,661) | (1,570) | (24,423) | (1,812) |
| Total other expenses | (23,787) | (533) | (26,657) | (871) |
| Loss before income taxes | (29,743) | (3,578) | (35,709) | (5,487) |
| Income tax (expense) benefit | (8) | 6 | (15) | 11 |
| Net loss | $ (29,751) | $ (3,572) | $ (35,724) | $ (5,476) |
| Net loss per share: | ||||
| Basic and diluted | $ (2.45) | $ (1.50) | $ (4.91) | $ (2.30) |
| Weighted average common shares outstanding: | ||||
| Basic and diluted | 12,157,757 | 2,381,041 | 7,272,447 | 2,381,041 |
| KEMPHARM, INC. | ||
| CONDENSED BALANCE SHEETS | ||
| (In Thousands, Except Share and Par Value Amounts) | ||
| As of June 30, | As of December 31, | |
| 2015 | 2014 | |
| (unaudited) | ||
| Assets | ||
| Current assets: | ||
| Cash and cash equivalents | $ 64,223 | $ 10,255 |
| Prepaid expenses and other current assets | 599 | 23 |
| Total current assets | 64,822 | 10,278 |
| Debt issuance costs, net | 1,301 | 1,468 |
| Property and equipment, net | 352 | 352 |
| Other long-term assets | 56 | 1,616 |
| Total assets | $ 66,531 | $ 13,714 |
| Liabilities, redeemable convertible preferred stock, and stockholders' deficit | ||
| Current liabilities: | ||
| Accounts payable and accrued expenses | $ 4,878 | $ 3,903 |
| Current portion of capital lease obligation | 32 | 32 |
| Total current liabilities | 4,910 | 3,935 |
| Convertible notes, net of discount | 7,550 | 7,235 |
| Term notes, net of discount | 11,326 | 10,853 |
| Derivative and warrant liability | 39,279 | 15,966 |
| Capital lease obligation, net of current portion | 11 | 26 |
| Total liabilities | 63,076 | 38,015 |
| Commitments and contingencies | ||
| Redeemable convertible preferred stock: | — | 24,207 |
| Stockholders' deficit: | ||
| Common stock, $0.0001 par value, 250,000,000 shares authorized, 14,229,552 shares issued and outstanding as of June 30, 2015 (unaudited); $0.0001 par value, 140,000,000 shares authorized, 2,381,041 shares issued and outstanding as of December 31, 2014 | 3 | 2 |
| Additional paid-in capital | 89,336 | 1,650 |
| Preferred stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued or outstanding as of June 30, 2015 (unaudited) or December, 31, 2014, respectively | — | — |
| Accumulated deficit | (85,884) | (50,160) |
| Total stockholders' deficit | 3,455 | (48,508) |
| Total liabilities, redeemable convertible preferred stock, and stockholders' deficit | $ 66,531 | $ 13,714 |
CONTACT: ForKemPharm, Inc. :Gordon K. "Rusty" Johnson 319-665-2575 info@kempharm.com Media / Investor Contacts:Jason Rando /Joshua Drumm , Ph.D. Tiberend Strategic Advisors, Inc. 212-375-2665 / 2664 jrando@tiberend.com jdrumm@tiberend.com
