“During early 2016, we made significant progress advancing both our commercial product portfolio as well as our therapeutics pipeline,” said
Dr. Bhatnagar continued, “We dosed the first patients in our Phase 2 clinical trial evaluating nasal carbon dioxide (CO2) for the treatment of trigeminal neuralgia (TN), and we look forward to data read-outs from this trial, as well as our ongoing Phase 2 trial for the treatment of cluster headache, later this year. We added significant medical device and diagnostics experience to our Board with the appointment of
First Quarter and Recent Highlights
CoSense and Neonatology-Focused Products
- Secured Exclusive Distribution Agreement with Bemes for CoSense in the U.S. Under the terms of the agreement, Bemes has the exclusive right to provide sales, marketing, distribution and field service activities for CoSense in the United States. Bemes and its network of sub-distributors allows comprehensive nationwide distribution of CoSense with 44 sales representatives covering all 50 states.
- Secured Exclusive Distribution Agreement with Shanghai CiiC for CoSense in
China. Shanghai CiiC has already commenced the regulatory process in China. CoSense sales are expected to commence by the end of 2016.
- Presented CoSense and Other Pipeline Candidate Data at the PAS 2016.
Capniaand collaborators presented five posters and gave one oral presentation featuring scientific data for its CoSense ETCO monitor and other pipeline candidates at the 2016 Pediatric Academic Societies Annual Meeting in Baltimore, MD.
- CoSense Showcased at the 2016
Mobile World Congress. The CoSense monitor was exhibited by Capnia’s technology partner, Harman International Industries, at the 2016 Mobile World Congressin Barcelona, Spain.
- Commenced Pilot Sales of Serenz to European Pharmacies. The product, a proprietary handheld nasal, non-inhaled CO2 device for the treatment of symptoms related to allergic rhinitis (AR, or nasal allergies), is now available over the counter in two
UK-based pharmacy chains, Paydens Groupand Weldricks Pharmacy Limited, with more than 150 retail pharmacy locations throughout the UK.
- Received Re-Certification of European CE Mark for Serenz for the Treatment of Nasal Allergy Symptoms. Re-certification allows for the sales of Serenz without restriction across the 28 member nations of the
- Enrolled First Patient in Phase 2 Clinical Trial Evaluating Nasal CO2 for the Symptomatic Treatment of Trigeminal Neuralgia. The multi-center, placebo-controlled, single-blind clinical trial is designed to enroll up to 50 patients with TN. The primary efficacy endpoint of the trial is pain relief as reported on a visual analog scale (VAS) in a subject diary, assessed through 24 hours from initial dose.
Capniaexpects to report top-line data from this trial by the end of 2016.
Rajen Dalalto the Board of Directors. Mr. Dalal brings to Capniaextensive leadership experience, having served as a senior executive and board member for various medical device and point-of-care diagnostic companies during his career.
- Closed Second Tranche of Private Placement of Convertible Preferred Stock. The
$5.4 milliontranche is the second transaction of a $10 millionconvertible preferred stock and warrant offering with funds managed by Sabby Management, LLC.
- Announced Expiration of Series B Warrants. As part of the Company’s initial public offering in
November 2014, Capniaissued Series B Warrants to purchase an aggregate 2,449,605 shares of the Company’s Common Stock. The Series B Warrants had variable settlement provisions including provisions for cashless conversion. As of February 12, 2016, all Series B warrants either have been exercised or expired.
First Quarter 2016 Financial Results
Total revenue recognized in the three months ended
Research and development expenses in the first quarter of 2016 were
Sales and marketing expenses in the first quarter of 2016 were
General and administrative expenses in the first quarter of 2016 increased to
The change in fair value of warrants for the three months ended
Net loss for the first quarter of 2016 was
Cash and cash equivalents at
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned product development, renewed focus on our therapeutic business, the potential to commence sales in
We may use terms such as "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation will prove to be accurate. Additional factors that could materially affect actual results can be found in
|Condensed Consolidated Balance Sheets|
|(In thousands, except share amounts)|
|As of March 31,||As of December 31,|
|Cash & Cash Equivalents||$||6,492||$||5,495|
|Prepaid expenses and other current assets||216||167|
|Total Current Assets||7,583||6,404|
|Property & Equipment, net||121||86|
|Other intangible assets, net||892||917|
|Liabilities and stockholders' equity|
|Accrued compensation and other current liabilities||1,317||1,634|
|Series B Warrant Liability||-||865|
|Total Current Liabilities||2,579||3,194|
|Series A Warrant Liability||558||1,213|
|Series C Warrant Liability||219||462|
|Total Long-Term Liabilities||977||1,784|
|Series A convertible preferred stock, $0.001 par value,|
|40,000 shares authorized, 8,335 and 4,555 shares issued and|
|outstanding at March 31, 2016 and December 31, 2015, respectively||-||-|
|Common stock, $0.001 par value, 100,000,000 shares|
|authorized, 15,403,111 and 14,017,909 shares issued and|
|outstanding at March 31, 2016 and December 31, 2015, respectively||15||14|
|Total stockholders' equity||5,834||3,223|
|Total liabilities and stockholders' equity||$||9,390||$||8,201|
|Condensed Consolidated Statement of Operations|
|(In thousands, except share and per share amounts)|
|Three Months Ended|
|Cost of product revenue||461||18|
|Gross profit (loss)||(14||)||4|
|Research and Development||1,772||878|
|Sales and Marketing||538||260|
|General and Administrative||1,939||1,292|
|Interest and other income (expense)|
|Interest expense, net||-||(1||)|
|Change in value of warrants||1,170||(6,174||)|
|Inducement charge for Series C warrants||-||(3,050||)|
|Basic and diluted net loss per common|
|Weighted-average common shares|
|outstanding used to calculate|
|basic and diluted net loss per|
Investor Relations Contact:
Michelle Carroll/ Susie Kim Argot Partners(212) 600-1902 firstname.lastname@example.org email@example.com