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Share Name | Share Symbol | Market | Type |
---|---|---|---|
KemPharm Inc | NASDAQ:KMPH | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 5.81 | 5.79 | 5.88 | 0 | 01:00:00 |
Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today at 5:00 p.m., ET
“The third quarter 2016 began a transformative period for KemPharm as we completed a strategic review of our development pipeline and prioritized KP415 and KP201/IR as our co-lead product candidates. We believe we achieved key milestones that should enable us to capitalize on the value opportunities that each of these product candidates offers to potentially address important patient, prescriber and market needs,” said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “We expect to report proof-of-concept data for KP415 by year-end, and we anticipate initiating human clinical trials of KP201/IR in 2017. KemPharm remains on target to potentially submit New Drug Applications (NDA) for each lead candidate product in 2018.”
“In addition to our clinical progress this quarter, we entered into a licensing agreement with Acura to utilize its proprietary Aversion® Technology with our current and in-development immediate release (IR) opioid prodrugs, starting with KP201/IR,” Dr. Mickle continued. “We believe our Ligand Activated Therapy (LAT) prodrug technology with an aversive formulation approach offers the potential to develop IR opioid therapeutics that may satisfy current FDA standards for abuse-deterrence and could potentially raise the bar on abuse-deterrence within the opioid space.”
Q3 2016 Financial Results: KemPharm’s reported net loss of $13.4 million, or $0.92 per basic and diluted share, for the quarter ended September 30, 2016, compared to net loss of $9.7 million, or $0.68 per basic and diluted share, for the same period in 2015. Net loss for third quarter of 2016 was driven primarily by a loss from operations of $10.4 million, interest expense, net, of $1.7 million and a fair value adjustment expense of $1.3 million for the quarter ended September 30, 2016. Loss from operations for the quarter was $10.4 million, compared to $6.5 million for the same period in 2015. The increase in loss from operations compared to the third quarter of 2015 was primarily due to $3.0 million of severance expense recorded in the third quarter of 2016 related to the deferral of commercial operations and realignment of financial resources and operational priorities during the period, and an increase in general and administrative costs of $0.9 million due primarily to an increase in headcount compared to the same period in 2015.
As of September 30, 2016, total cash, cash equivalents, restricted cash, marketable securities and long-term investments was $92.0 million, which reflected a decrease of $10.6 million compared to June 30, 2016.
Conference Call Information:The company will host a conference call and live audio webcast with slide presentation on Wednesday, November 9, 2016, at 5:00 p.m. ET, to discuss its corporate and financial results for the third quarter of 2016. Interested participants and investors may access the conference call by dialing either:
The live webcast with accompanying slides will be accessible via the Investor Relations section of the KemPharm website http://investors.kempharm.com/. An archive of the webcast and presentation will remain available for 90 days beginning at approximately 6:00 p.m., ET on November 9, 2016.
Third Quarter and Recent Activities:
Clinical & Regulatory
Corporate & Operational
About KemPharm
KemPharm is a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its LAT prodrug platform technology. KemPharm utilizes its LAT platform technology to generate improved prodrug versions of FDA-approved drugs in the high-need areas of pain, ADHD and other CNS disorders.
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. These forward-looking statements include statements regarding the expected features and characteristics of KP415, KP201/IR and KP511/ER the expected timing of potential submissions of NDAs for KP415, KP201/IR and KP511/ER, the expected timing of the initiation and completion of clinical trials and the timeline and potential outcome of the FDRR process for Apadaz. These forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to KemPharm 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: KemPharm's financial resources and whether they will be sufficient to meet KemPharm'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 KemPharm'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. KemPharm'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’s business are described in additional detail in KemPharm's Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, and KemPharm’s other Periodic and Current Reports filed with the Securities and Exchange Commission. KemPharm is 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.
KEMPHARM, INC.UNAUDITED CONDENSED STATEMENTS OF OPERATIONS(In Thousands, Except Share and Per Share Amounts)
Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||||||||
Revenue | $ | — | $ | — | $ | — | $ | — | ||||||||||||||
Operating expenses: | ||||||||||||||||||||||
Research and development | 4,287 | 4,328 | 12,509 | 9,215 | ||||||||||||||||||
General and administrative | 3,104 | 2,152 | 11,127 | 6,317 | ||||||||||||||||||
Severance expense | 3,010 | — | 3,010 | — | ||||||||||||||||||
Total operating expenses | 10,401 | 6,480 | 26,646 | 15,532 | ||||||||||||||||||
Loss from operations | (10,401 | ) | (6,480 | ) | (26,646 | ) | (15,532 | ) | ||||||||||||||
Other (expense) income: | ||||||||||||||||||||||
Loss on extinguishment of debt | — | — | (4,740 | ) | — | |||||||||||||||||
Interest expense related to amortization of debt issuance costs and discount | (390 | ) | (479 | ) | (1,225 | ) | (1,434 | ) | ||||||||||||||
Interest expense on debt principal | (1,441 | ) | (687 | ) | (4,066 | ) | (1,973 | ) | ||||||||||||||
Fair value adjustment | (1,299 | ) | (2,089 | ) | 29,742 | (26,512 | ) | |||||||||||||||
Interest and other income | 98 | 11 | 344 | 17 | ||||||||||||||||||
Total other (expense) income | (3,032 | ) | (3,244 | ) | 20,055 | (29,902 | ) | |||||||||||||||
Loss before income taxes | (13,433 | ) | (9,724 | ) | (6,591 | ) | (45,434 | ) | ||||||||||||||
Income tax benefit (expense) | 19 | (20 | ) | 11 | (27 | ) | ||||||||||||||||
Net loss | $ | (13,414 | ) | $ | (9,744 | ) | $ | (6,580 | ) | $ | (45,461 | ) | ||||||||||
Net loss per share: | ||||||||||||||||||||||
Basic and diluted | $ | (0.92 | ) | $ | (0.68 | ) | $ | (0.45 | ) | $ | (4.71 | ) | ||||||||||
Weighted average common shares outstanding: | ||||||||||||||||||||||
Basic and diluted | 14,646,982 | 14,232,133 | 14,580,289 | 9,643,231 | ||||||||||||||||||
KEMPHARM, INC. CONDENSED BALANCE SHEETS (In Thousands, Except Share and Par Value Amounts)
As of September 30, | As of December 31, | |||||||||
2016 | 2015 | |||||||||
(unaudited) | ||||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ | 20,846 | $ | 32,318 | ||||||
Restricted cash | 1,100 | — | ||||||||
Marketable securities | 42,679 | 19,002 | ||||||||
Prepaid expenses and other current assets | 636 | 2,758 | ||||||||
Total current assets | 65,261 | 54,078 | ||||||||
Property and equipment, net | 1,456 | 403 | ||||||||
Long-term investments | 27,355 | — | ||||||||
Other long-term assets | 472 | 109 | ||||||||
Total assets | $ | 94,544 | $ | 54,590 | ||||||
Liabilities and stockholders' deficit | ||||||||||
Current liabilities: | ||||||||||
Accounts payable and accrued expenses | $ | 5,599 | $ | 4,906 | ||||||
Current portion of convertible notes | — | 1,369 | ||||||||
Current portion of term notes | — | 2,041 | ||||||||
Current portion of capital lease obligation | 105 | 26 | ||||||||
Total current liabilities | 5,704 | 8,342 | ||||||||
Convertible notes, net | 90,779 | 7,412 | ||||||||
Term notes, net | — | 11,118 | ||||||||
Derivative and warrant liability | 7,342 | 37,839 | ||||||||
Other long-term liabilities | 521 | — | ||||||||
Total liabilities | 104,346 | 64,711 | ||||||||
Commitments and contingencies (Note D) | ||||||||||
Stockholders' deficit: | ||||||||||
Common stock, $0.0001 par value, 250,000,000 shares authorized, 14,646,982 shares issued and outstanding as of September 30, 2016 (unaudited); 14,490,954 shares issued and outstanding as of December 31, 2015 | 1 | 1 | ||||||||
Additional paid-in capital | 101,601 | 94,702 | ||||||||
Preferred stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued or outstanding as of September 30, 2016 (unaudited) or December 31, 2015 | — | — | ||||||||
Accumulated deficit | (111,404 | ) | (104,824 | ) | ||||||
Total stockholders' deficit | (9,802 | ) | (10,121 | ) | ||||||
Total liabilities and stockholders' deficit | $ | 94,544 | $ | 54,590 | ||||||
Investor Contacts: Jason Rando / Joshua Drumm, Ph.D. Tiberend Strategic Advisors, Inc. 212-375-2665 / 2664 jrando@tiberend.com jdrumm@tiberend.com Media Contact: Daniel L. Cohen Executive VP, Government and Public Relations KemPharm, Inc. 202-329-1825 dcohen@kempharm.com
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