UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________
Form 8-K
_____________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event Reported): August 3, 2016
CONATUS PHARMACEUTICALS INC.
(Exact Name of Registrant as Specified in Charter)
Delaware | 001-36003 | 20-3183915 |
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification Number) |
16745 West Bernardo Drive, Suite 200, San Diego, CA 92127 |
(Address of Principal Executive Offices) (Zip Code) |
(858) 376-2600
(Registrant's telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: | ||
[ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
[ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
[ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
[ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02. Results of Operations and Financial Condition.
On August 3, 2016, Conatus Pharmaceuticals Inc. issued a press release announcing its financial results for the quarter and six months ended June 30, 2016. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. In accordance with General Instruction B.2. of Form 8-K, the information in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) ExhibitsExhibit No. Description 99.1 Press release issued on August 3, 2016
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
CONATUS PHARMACEUTICALS INC. | ||
Date: August 3, 2016 | By: | /s/ Charles J. Cashion |
Charles J. Cashion | ||
Senior Vice President, Finance, Chief Financial Officer and Secretary | ||
EXHIBIT 99.1
Conatus Pharmaceuticals Reports Second Quarter 2016 Financial Results and Program Updates
SAN DIEGO, Aug. 03, 2016 (GLOBE NEWSWIRE) -- Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced financial results for the quarter and six months ended June 30, 2016, and provided updates on its clinical development programs.
Financial Results
The net loss for the second quarter of 2016 was $6.5 million compared with $6.1 million for the second quarter of 2015. The net loss for the first six months of 2016 was $13.7 million compared with $12.0 million for the first six months of 2015.
Research and development expenses were $4.2 million for the second quarter of 2016 compared with $4.1 million for the second quarter of 2015. Research and development expenses were $8.9 million for the first six months of 2016 compared with $8.0 million for the first six months of 2015. The increases in research and development expenses were primarily due to higher external emricasan clinical trial and manufacturing costs.
General and administrative expenses were $2.2 million for the second quarter of 2016 compared with $2.0 million for the second quarter of 2015. The quarterly increase in general and administrative expenses was primarily due to higher personnel costs and consulting fees. General and administrative expenses were $4.8 million for the first six months of 2016 compared with $4.1 million for the first six months of 2015. The year-to-date increase in general and administrative expenses was primarily due to higher personnel costs and higher consulting, legal and accounting fees.
Cash, cash equivalents and marketable securities were $30.2 million at June 30, 2016, compared with $36.5 million at December 31, 2015. The company believes current financial resources are sufficient to maintain operations and ongoing clinical trials for at least the next 12 months.
Program Updates
Conatus is developing emricasan, a first-in-class, orally active pan-caspase inhibitor, for the treatment of patients with chronic liver disease. During the second quarter, the company announced:
Conatus has two ongoing emricasan Phase 2 clinical trials:
The company plans to initiate the following additional emricasan clinical trials on a staggered basis through early 2017 as resources permit and expects top-line results to be available periodically beginning in 2018:
Conference Call and Audio Webcast
Conatus will host a conference call and webcast at 4:30 p.m. Eastern Time today, August 3, to discuss quarterly financial results and provide an update on the company’s development programs. To access the conference call, please dial 877-312-5857 (domestic) or 970-315-0455 (international) at least five minutes prior to the start time and refer to conference ID 50509324. A live and archived webcast of the call will be available in the Investors section of the company’s website at www.conatuspharma.com.
About Conatus Pharmaceuticals
Conatus is a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease. Conatus is developing emricasan, a first-in-class, orally active pan-caspase protease inhibitor, for the treatment of patients with chronic liver disease. To date, emricasan has been studied in over 650 subjects in 16 clinical trials across a broad range of liver disease etiologies and stages of progression. In multiple clinical trials, emricasan has demonstrated statistically significant, rapid and sustained reductions in elevated levels of key biomarkers of apoptosis and inflammation that are implicated in the severity and progression of liver disease. Recent emricasan clinical trial results have demonstrated emricasan’s ability to provide significant improvements in clinically important validated surrogate endpoints of portal hypertension and liver function across multiple etiologies in the subgroups of liver cirrhosis patients with highest medical need. For additional information, please visit www.conatuspharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward looking statements, including statements regarding: the sufficiency of current financial resources; the timelines to announce results from the POLT-HCV-SVR trial and results from the ENCORE-NF trial; and the trial details and timelines to initiate and announce results from the ENCORE-PH, ENCORE-LF and ENCORE-XT trials. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including: Conatus’ ability to initiate and successfully complete current and future clinical trials; Conatus’ dependence on its ability to obtain regulatory approval for, and then successfully commercialize emricasan, which is Conatus’ only drug candidate; Conatus’ reliance on third parties to conduct its clinical trials, enroll subjects, manufacture its preclinical and clinical drug supplies and manufacture commercial supplies of emricasan, if approved; potential adverse side effects or other safety risks associated with emricasan that could delay or preclude its approval; results of current and future clinical trials of emricasan; the potential for competing products to limit the clinical trial enrollment opportunities for emricasan in certain indications; the uncertainty of the FDA’s and other regulatory agencies’ approval processes and other regulatory requirements; Conatus’ ability to fully comply with numerous federal, state and local laws and regulatory requirements applicable to it; Conatus’ ability to obtain additional financing in order to complete the development and commercialization of emricasan; Conatus may use its financial resources faster than it anticipates; and those risks described in Conatus’ prior press releases and in the periodic reports it files with the Securities and Exchange Commission. The events and circumstances reflected in Conatus’ forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, Conatus does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Conatus Pharmaceuticals Inc. | ||||||||||||||||||
Selected Condensed Financial Information | ||||||||||||||||||
(Unaudited) | ||||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||||
Statements of Operations | June 30, | June 30, | ||||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||||
Operating expenses: | ||||||||||||||||||
Research and development | $ | 4,246,488 | $ | 4,070,127 | $ | 8,944,950 | $ | 7,953,740 | ||||||||||
General and administrative | 2,238,134 | 1,994,352 | 4,814,261 | 4,075,661 | ||||||||||||||
Total operating expenses | 6,484,622 | 6,064,479 | 13,759,211 | 12,029,401 | ||||||||||||||
Other income (expense): | ||||||||||||||||||
Interest income | 34,377 | 17,977 | 61,355 | 29,396 | ||||||||||||||
Interest expense | (17,500 | ) | (17,500 | ) | (35,000 | ) | (35,000 | ) | ||||||||||
Other (expense) income | (3,400 | ) | 6,748 | (10,173 | ) | (1,913 | ) | |||||||||||
Total other income (expense) | 13,477 | 7,225 | 16,182 | (7,517 | ) | |||||||||||||
Net loss | $ | (6,471,145 | ) | $ | (6,057,254 | ) | $ | (13,743,029 | ) | $ | (12,036,918 | ) | ||||||
Net loss per share, basic and diluted | $ | (0.30 | ) | $ | (0.31 | ) | $ | (0.65 | ) | $ | (0.69 | ) | ||||||
Weighted average shares outstanding used in computing net loss per share, basic and diluted | 21,542,188 | 19,338,167 | 21,085,610 | 17,468,148 | ||||||||||||||
June 30, | December 31, | |||||||||||||||||
Balance Sheets | 2016 | 2015 | ||||||||||||||||
Assets | ||||||||||||||||||
Current assets: | ||||||||||||||||||
Cash, cash equivalents and marketable securities | $ | 30,202,528 | $ | 36,508,109 | ||||||||||||||
Prepaid and other current assets | 876,823 | 1,982,031 | ||||||||||||||||
Total current assets | 31,079,351 | 38,490,140 | ||||||||||||||||
Property and equipment, net | 311,381 | 344,734 | ||||||||||||||||
Other assets | 876,130 | 892,394 | ||||||||||||||||
Total assets | $ | 32,266,862 | $ | 39,727,268 | ||||||||||||||
Liabilities and stockholders' equity | ||||||||||||||||||
Current liabilities | $ | 3,235,359 | $ | 3,982,698 | ||||||||||||||
Note payable | 1,000,000 | 1,000,000 | ||||||||||||||||
Deferred rent | 190,377 | 204,224 | ||||||||||||||||
Stockholders' equity | 27,841,126 | 34,540,346 | ||||||||||||||||
Total liabilities and stockholders' equity | $ | 32,266,862 | $ | 39,727,268 | ||||||||||||||
MEDIA: David Schull
Russo Partners, LLC
(858) 717-2310
David.Schull@RussoPartnersLLC.com
INVESTORS: Alan Engbring
Conatus Pharmaceuticals Inc.
(858) 376-2637
aengbring@conatuspharma.com