Capnia Reports First Quarter 2015 Financial Results
"In the first quarter of 2015, we have achieved numerous key milestones and corporate developments that set the stage for what we believe will be a productive future for the company," said
"The
First Quarter 2015 and Recent Highlights
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Raised
$3.8 Million from Series B Warrant Exercise Transaction. In March,Capnia completed a privately negotiated transaction with certain holders ofCapnia's Series B warrants who agreed to exercise their Series B warrants to purchase an aggregate of 589,510 shares ofCapnia's Common Stock at an exercise price of$6.50 per share, resulting in net proceeds to the Company of approximately$3.8 million . This transaction also reduced the number of outstanding Series B Warrants that contain a cashless exercise feature which results in an increasing number of shares of Common Stock issuable without consideration.
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Awarded NIH Grant to Develop Sickle Cell Disease Screening in Developing Countries.In April,
Capnia announced it was awarded a Small Business Innovation Research (SBIR) Phase I grant for$220,000 by the National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH). This grant will be used to help fund the development of a modified CoSense device that is suitable for field use in developing countries with high prevalence of Sickle Cell Disease (SCD).
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Published Scientific Data Supporting CoSense's Utility in Screening Children for SCD/SCA. In February, a peer-reviewed paper, titled "Point-of-Care End-Tidal Carbon Monoxide Reflects Severity of Hemolysis in Sickle Cell Anemia," was published in the journal Pediatric Blood & Cancer. Results from the published study conducted at
UCSF Benioff Children's Hospital demonstrate that CoSense accurately distinguishes children with SCA from age-matched healthy controls by measuring end-tidal carbon monoxide (ETCO) with a simple, rapid, non-invasive breath test. These data suggest that ETCO may be a valuable tool for ongoing non-invasive monitoring of the severity of hemolysis in SCA and that ETCO has potential for use as a point-of-care screening test for SCA.
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Published Scientific Data Supporting CoSense's Utility in Screening Neonates and Children for Hemolytic Conditions.In March, a peer-reviewed paper titled "End-tidal carbon monoxide as an indicator of the hemolytic rate," was published in the journal Blood Cells, Molecules and Diseases. Results from the published study conducted at
Intermountain Healthcare demonstrate that ETCO values of neonates and children with known hemolytic disorders were higher than age-matched healthy controls (p<0.0001), indicating that CoSense recognizes hemolysis in neonates. These results show that measuring ETCO may be an effective way to identify pathological hemolytic conditions (e.g., hereditary spherocytosis, G6PD deficiency, pyruvate kinase deficiency or Rh/ABO hemolytic disease).
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Published Scientific Data on CoSense® in Acta Paediatrica. In January, a peer-reviewed paper titled "Evaluation of a new end-tidal carbon monoxide monitor from the bench to the bedside," was published online in Acta Paediatrica. Results from the published study conducted by
Stanford University demonstrated that CoSense is accurate and precise. Furthermore, these results indicate that CoSense can be used as a reliable measurement of the rate of hemolysis and, therefore, bilirubin production. ETCO, corrected for ambient carbon monoxide, or ETCOc, has been recommended in the 2004American Academy of Pediatrics (AAP) guideline, for confirming the presence or absence of hemolysis. The preliminary data presented in the publication provides new evidence that the CoSense monitor meets the criteria of the AAP guidelines.
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Applied for Orphan Drug Designation in the U.S. for the Treatment of Trigeminal Neuralgia. In December,
Capnia submitted an application to theU.S. Food and Drug Administration (FDA) Office of Orphan Product Development requesting Orphan Drug Designation for its nasal CO2 technology for the treatment of TN. TN is a clinical condition characterized by debilitating pain in regions of the face innervated by one or more divisions of the trigeminal nerve.Capnia received a response from the Office of Orphan Product Development, and is continuing its discussions with theFDA regarding Orphan Drug Designation for its nasal CO2 technology in this indication.
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Planned Partnership with Clinvest® to Develop Treatment for Episodic Cluster Headache. In the first quarter, an agreement betweenCapnia and Clinvest was executed, in which Clinvest will conduct an investigator-initiated trial to evaluate the safety and efficacy of nasal CO2 for the treatment of episodic cluster headache in 25 subjects. The Company expects to initiate this study in the second quarter of 2015.
First Quarter 2015 Financial Results
Total revenue recognized in the three months ended
Research and development expenses in the first quarter of 2015 were
Sales and marketing expenses in the first quarter of 2015 were
General and administrative expenses in the first quarter of 2015 increased to
Interest expense decreased by
The change in fair value of warrants expense in the first quarter of 2015 increased by
The inducement charge for Series C Warrants in the first quarter increased to
Net loss for the first quarter of 2015 was
Cash, cash equivalents, and marketable securities at
About
Forward-Looking Statements
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 and clinical trials and that measuring ETCO may be an effective way to identify pathological hemolytic conditions.
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
| Capnia, Inc. | ||
| Condensed Statements of Operations and Comprehensive Loss | ||
| (In thousands, except per share amounts) | ||
| (unaudited) | ||
| Three Months Ended | ||
| March 31, | ||
| 2015 | 2014 | |
| Revenue | $ 22 | -- |
| Cost of revenue | 18 | -- |
| Gross Profit | 4 | -- |
| Expenses | ||
| Research and Development | 878 | 372 |
| Sales and Marketing | 260 | -- |
| General and Administrative | 1,292 | 312 |
| Total expenses | 2,430 | 684 |
| Operating income (loss) | (2,426) | (684) |
| Interest and other income (expense) | ||
| Interest income | -- | -- |
| Interest expense | (1) | (388) |
| Change in value of warrants | (6,174) | 246 |
| Inducement charge for Series C warrants | (3,050) | |
| Other expense | -- | (8) |
| Net loss | $ (11,651) | $ (834) |
| Basic and diluted net loss per common share | $ (1.67) | $ (1.56) |
| Weighted-average common shares outstanding used to calculate basic and diluted net loss per common share | 6,965,483 | 535,685 |
| Capnia, Inc. | ||
| Condensed Balance Sheets | ||
| (In thousands) | ||
| (unaudited) | ||
| As of March 31, | As of December 31, | |
| 2015 | 2014 | |
| Assets | (Revised) | |
| Current Assets | ||
| Cash & Cash Equivalents | $ 9,529 | $ 7,957 |
| Restricted Cash | 20 | 20 |
| Accounts Receivable | 8 | |
| Inventory | 206 | 109 |
| Prepaid expenses and other current assets | 260 | 252 |
| Total Current Assets | 10,023 | 8,338 |
| Long-term Assets | ||
| Property & Equipment, net | 44 | 58 |
| Total Assets | $ 10,067 | $ 8,396 |
| Liabilities, convertible preferred stock and stockholders' deficit | ||
| Current Liabilities | ||
| Accounts Payable | $ 621 | $ 987 |
| Accrued expenses | 438 | 201 |
| Line of Credit | -- | 102 |
| Total Current Liabilities | 1,059 | 1,290 |
| Long-Term Liabilities | ||
| Series A Warrant Liability | 3,582 | 857 |
| Series B Warrant Liability | 14,180 | 17,439 |
| Series C Warrant Liability | 2,549 | |
| Total Long-Term Liabilities | 20,311 | 18,296 |
| Total Liabilites | 21,370 | 19,586 |
| Stockholder's deficit | ||
| Common stock, $0.001 par value, 100,000,000 shares authorized at March 31, 2014 and December 31, 2014 7,448,389 and 6,769,106 shares issued and oustanding at March 31, 2015 and December 31, 2014 | 7 | 7 |
| Additional paid-in-capital | 70,679 | 59,141 |
| Accumulated deficit | (81,989) | (70,338) |
| Total stockholders' deficit | (11,303) | (11,190) |
| Total liabilities and stockholders' deficit | $ 10,067 | $ 8,396 |
CONTACT: Capnia Contact:
David O'Toole
Chief Financial Officer
Capnia, Inc.
(650) 353-5146
dotoole@capnia.com
Investor Relations Contact:
Michelle Carroll /Susie Kim
Argot Partners
(212) 600-1902
michelle@argotpartners.com
susan@argotpartners.com
