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): November 1, 2017
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)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company [ X ]
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ X ]
Item 2.02. Results of Operations and Financial Condition.
On November 1, 2017, Conatus Pharmaceuticals Inc. issued a press release announcing its financial results for the quarter and nine months ended September 30, 2017. 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 November 1, 2017
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: November 1, 2017 | By: | /s/ Keith W. Marshall, Ph.D., M.B.A. |
Keith W. Marshall, Ph.D., M.B.A. | ||
Executive Vice President, Chief Operating Officer and Chief Financial Officer | ||
EXHIBIT 99.1
Conatus Pharmaceuticals Reports Third Quarter 2017 Financial Results and Program Updates
SAN DIEGO, Nov. 01, 2017 (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 nine months ended September 30, 2017, and provided updates on its development programs.
Program Updates
In collaboration with Novartis under terms of the company’s Option, Collaboration and License Agreement with Novartis, which was executed in December 2016, Conatus is conducting four randomized, double-blind, placebo-controlled Phase 2b clinical trials designed to evaluate emricasan treatment in various patient populations, including three EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) clinical trials in patients with fibrosis or cirrhosis caused by nonalcoholic steatohepatitis (NASH), and a fourth clinical trial in POLT-HCV-SVR patients:
Results from the four ongoing emricasan clinical trials are expected to support the design of Phase 3 clinical efficacy and safety trials.
Pipeline Expansion Plans
In October 2017, the European Medicines Agency (EMA) granted Orphan Drug Designation in the European Union to the company’s pan-caspase inhibitor IDN-7314 for the treatment of primary sclerosing cholangitis (PSC), a disease affecting bile ducts in the liver, which can lead to cirrhosis and liver failure. In June 2017, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation in the United States to IDN-7314 for the treatment of PSC.
These orphan drug designations were based on previously reported data with IDN-7314 demonstrating reduction of relevant biomarkers in two preclinical models of PSC. New results, showing that IDN-7314 markedly diminished inflammasome activation and reduced liver injury in a preclinical model of PSC, were presented in October 2017 at The Liver Meeting®, the annual meeting of the American Association for the Study of Liver Diseases (AASLD). In a separate study, IDN-7314 reduced biochemical markers in a new acute preclinical model of PSC.
Conatus believes the orphan drug designations, along with the growing body of preclinical data, warrant further evaluation of IDN-7314 as a potential product candidate in PSC as a component of its initial pipeline expansion plans. The company’s ongoing pipeline expansion activities also include:
Conatus may pursue the development of product candidates in liver disease and in other related disease areas.
Financial Results
The net loss for the third quarter of 2017 was $4.0 million compared with $6.9 million for the third quarter of 2016. The net loss for the first nine months of 2017 was $13.0 million compared with $20.6 million for the first nine months of 2016.
Total revenues were $9.6 million for the third quarter of 2017 and $26.6 million for the first nine months of 2017, compared with $0.0 million for the comparable periods in 2016. Total revenues for both periods in 2017 consisted of collaboration revenue related to the Option, Collaboration and License Agreement with Novartis.
Research and development expenses were $11.2 million for the third quarter of 2017 compared with $4.8 million for the third quarter of 2016. Research and development expenses were $32.3 million for the first nine months of 2017 compared with $13.8 million for the first nine months of 2016. The increases in research and development expenses were primarily due to the ramp up of our ENCORE-NF, ENCORE-PH and ENCORE-LF clinical trials.
General and administrative expenses were $2.4 million for the third quarter of 2017 compared with $2.1 million for the third quarter of 2016. General and administrative expenses were $7.4 million for the first nine months of 2017 compared with $6.9 million for the first nine months of 2016. The increases in general and administrative expenses were primarily due to higher personnel costs and professional fees.
Cash, cash equivalents and marketable securities were $85.2 million at September 30, 2017, compared with $77.0 million at December 31, 2016. Based primarily on lower than expected spending on in-licensing and internal pipeline development, the company is now projecting a year-end 2017 balance of between $70 million and $75 million. The company believes its current and forecasted financial resources are sufficient to maintain operations and ongoing emricasan clinical development activities through the end of 2019, as well as to fund anticipated pipeline expansion activities.
Conference Call and Audio Webcast
Conatus will host a conference call and audio webcast at 4:30 p.m. Eastern Time today to discuss the financial results and provide a corporate update. 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 99505370. A live and archived audio webcast of the call will also be available in the Investors section of the Conatus 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. In collaboration with Novartis, Conatus is developing its lead compound, emricasan, for the treatment of patients with chronic liver disease. Emricasan is a first-in-class, orally active pan-caspase inhibitor designed to reduce the activity of enzymes that mediate inflammation and apoptosis. Conatus believes that by reducing the activity of these enzymes, caspase inhibitors have the potential to interrupt the progression of a variety of diseases. 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 timelines to announce results from the ENCORE-NF, the ENCORE-PH, the ENCORE-LF, and the POLT-HCV-SVR clinical trials; evaluation of IDN-7314 and other potential product candidates; the projected year-end cash balance; the sufficiency of current financial resources to maintain operations and ongoing clinical development activities through 2019, as well as to fund anticipated pipeline expansion activities; and caspase inhibitors' potential to interrupt the progression of a variety of diseases. 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 successfully enroll patients in and complete its ongoing and planned clinical trials; Novartis continuing development and commercialization of emricasan; Conatus’ reliance on third parties to conduct its clinical trials, including the enrollment of patients, and manufacture its clinical drug supplies of emricasan; potential adverse side effects or other safety risks associated with emricasan that could delay or preclude its approval; results of future clinical trials of emricasan; Conatus’ ability to obtain additional financing in order to co-commercialize emricasan or develop other compounds; 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.
CONTACT: Alan Engbring
Conatus Pharmaceuticals Inc.
(858) 376-2637
aengbring@conatuspharma.com
Conatus Pharmaceuticals Inc. | ||||||||||||||||||
Selected Condensed Financial Information | ||||||||||||||||||
(Unaudited) | ||||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||||
Statements of Operations | September 30, | September 30, | ||||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||||
Revenues: | ||||||||||||||||||
Collaboration revenue | $ | 9,565,890 | $ | - | $ | 26,572,397 | $ | - | ||||||||||
Operating expenses: | ||||||||||||||||||
Research and development | 11,165,150 | 4,825,421 | 32,308,786 | 13,770,371 | ||||||||||||||
General and administrative | 2,449,382 | 2,069,447 | 7,406,591 | 6,883,708 | ||||||||||||||
Total operating expenses | 13,614,532 | 6,894,868 | 39,715,377 | 20,654,079 | ||||||||||||||
Loss from operations | (4,048,642 | ) | (6,894,868 | ) | (13,142,980 | ) | (20,654,079 | ) | ||||||||||
Other income/expense | 48,264 | 27,958 | 102,970 | 44,140 | ||||||||||||||
Net loss | $ | (4,000,378 | ) | $ | (6,866,910 | ) | $ | (13,040,010 | ) | $ | (20,609,939 | ) | ||||||
Net loss per share, basic and diluted | $ | (0.13 | ) | $ | (0.31 | ) | $ | (0.46 | ) | $ | (0.96 | ) | ||||||
Weighted average shares outstanding used in computing net loss per share, basic and diluted | 30,004,037 | 22,410,702 | 28,104,199 | 21,527,993 | ||||||||||||||
September 30, | December 31, | |||||||||||||||||
Balance Sheets | 2017 | 2016 | ||||||||||||||||
Assets | ||||||||||||||||||
Current assets: | ||||||||||||||||||
Cash, cash equivalents and marketable securities | $ | 85,183,887 | $ | 77,015,124 | ||||||||||||||
Other receivables | - | 2,500,000 | ||||||||||||||||
Prepaid and other current assets | 1,339,208 | 937,436 | ||||||||||||||||
Total current assets | 86,523,095 | 80,452,560 | ||||||||||||||||
Property and equipment, net | 204,914 | 261,446 | ||||||||||||||||
Other assets | 2,538,211 | 1,609,834 | ||||||||||||||||
Total assets | $ | 89,266,220 | $ | 82,323,840 | ||||||||||||||
Liabilities and stockholders' equity | ||||||||||||||||||
Current liabilities: | ||||||||||||||||||
Accounts payable and other accrued expenses | $ | 12,748,770 | $ | 7,662,796 | ||||||||||||||
Current portion of deferred revenue | 19,454,795 | 30,897,192 | ||||||||||||||||
Note payable | - | 1,000,000 | ||||||||||||||||
Total current liabilities | 32,203,565 | 39,559,988 | ||||||||||||||||
Deferred revenue, less current portion | 12,673,762 | 20,803,762 | ||||||||||||||||
Convertible note payable | 12,968,493 | - | ||||||||||||||||
Deferred rent | 139,392 | 171,544 | ||||||||||||||||
Stockholders' equity | 31,281,008 | 21,788,546 | ||||||||||||||||
Total liabilities and stockholders' equity | $ | 89,266,220 | $ | 82,323,840 | ||||||||||||||