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): May 2, 2018
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 May 2, 2018, Conatus Pharmaceuticals Inc. issued a press release announcing its financial results for the quarter ended March 31, 2018. 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 May 2, 2018
SIGNATURES
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: May 2, 2018 | 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 First Quarter 2018 Financial Results and Program Updates
SAN DIEGO, May 02, 2018 (GLOBE NEWSWIRE) -- Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development of novel medicines to treat liver disease, today announced financial results for the first quarter ended March 31, 2018, and provided updates on its development programs.
Program Updates
In April 2018, the company reported top-line results from its exploratory Phase 2b POLT-HCV-SVR proof-of-concept clinical trial in post-orthotopic liver transplant (POLT) recipients with liver fibrosis or cirrhosis post-transplant as a result of recurrent hepatitis C virus (HCV) infection who had successfully achieved a sustained viral response (SVR) following HCV antiviral therapy. The overall safety profile after two years of dosing in an immunocompromised patient population was similar in the emricasan and placebo groups. Although the trial did not meet its primary endpoint in the heterogeneous overall trial population, emricasan demonstrated a significant anti-fibrotic treatment effect in the prespecified subgroup of patients with advanced fibrosis and early cirrhosis. At this time, there are no plans to initiate additional clinical trials on the basis of the POLT-HCV-SVR trial alone.
In the POLT-HCV-SVR clinical trial, a separate patient population was studied versus the other three Phase 2b clinical trials in the company’s collaboration with Novartis – the EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) trials, designed to evaluate emricasan in patients with fibrosis or cirrhosis caused by nonalcoholic steatohepatitis (NASH):
In February 2018, the company initiated a Phase 2 post-treatment follow-up clinical trial to monitor long-term adverse event rates in patients treated with emricasan or placebo in any of the four Phase 2b clinical trials.
Financial Results
Total revenues were $9.7 million for the first quarter of 2018 compared with $7.0 million for the first quarter of 2017. Total revenues consisted of collaboration revenues related to the Novartis agreement. The increase was primarily due to higher revenue from reimbursable costs related to the Novartis agreement, as well as the effect of adoption of the ASC 606 revenue recognition standard.
Research and development expenses were $12.1 million for the first quarter of 2018 compared with $7.9 million for the first quarter of 2017. The increase in research and development expenses was primarily due to the ramp up of the ENCORE-PH and ENCORE-LF clinical trials and higher spending on new product candidate development.
General and administrative expenses were $2.7 million for the first quarter of 2018 compared with $2.8 million for the first quarter of 2017.
The net loss was $5.0 million for the first quarter of 2018 compared with $3.6 million for the first quarter of 2017.
Cash, cash equivalents and marketable securities were $66.8 million at March 31, 2018, compared with $74.9 million at December 31, 2017, and a projected year-end 2018 balance of between $35 million and $40 million. The company believes that current financial resources, together with the anticipated reimbursements for 50% of the costs for the ongoing clinical trials, without including any potential milestone payments under the Novartis collaboration, are sufficient to maintain operations through top-line results from the three ENCORE Phase 2b clinical trials by the end of 2019, as well as to fund initial 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 5286754. 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 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-PH, the ENCORE-NF, and the ENCORE-LF clinical trials; 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 initial 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 | ||||||||||
| (In thousands, except per share data) | ||||||||||
| (Unaudited) | ||||||||||
| Three Months Ended | ||||||||||
| Statements of Operations | March 31, | |||||||||
| 2018 | 2017 | |||||||||
| Revenues: | ||||||||||
| Collaboration revenue | $ | 9,737 | $ | 6,998 | ||||||
| Operating expenses: | ||||||||||
| Research and development | 12,081 | 7,926 | ||||||||
| General and administrative | 2,713 | 2,763 | ||||||||
| Total operating expenses | 14,794 | 10,689 | ||||||||
| Loss from operations | (5,057 | ) | (3,691 | ) | ||||||
| Other income/expense | 39 | 68 | ||||||||
| Net loss | $ | (5,018 | ) | $ | (3,623 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.17 | ) | $ | (0.14 | ) | ||||
| Weighted average shares outstanding used in computing net loss per share, basic and diluted | 30,048 | 26,163 | ||||||||
| March 31, | December 31, | |||||||||
| Balance Sheets | 2018 | 2017 | ||||||||
| Assets | ||||||||||
| Current assets: | ||||||||||
| Cash, cash equivalents and marketable securities | $ | 66,751 | $ | 74,853 | ||||||
| Collaboration receivables | 5,847 | 3,367 | ||||||||
| Prepaid and other current assets | 1,231 | 1,004 | ||||||||
| Total current assets | 73,829 | 79,224 | ||||||||
| Property and equipment, net | 157 | 179 | ||||||||
| Other assets | 2,660 | 2,538 | ||||||||
| Total assets | $ | 76,646 | $ | 81,941 | ||||||
| Liabilities and stockholders' equity | ||||||||||
| Current liabilities: | ||||||||||
| Accounts payable and other accrued expenses | $ | 15,739 | $ | 13,970 | ||||||
| Current portion of deferred revenue | 14,868 | 14,172 | ||||||||
| Total current liabilities | 30,607 | 28,142 | ||||||||
| Deferred revenue, less current portion | 9,231 | 12,519 | ||||||||
| Convertible note payable | 13,343 | 13,158 | ||||||||
| Deferred rent | 113 | 126 | ||||||||
| Stockholders' equity | 23,352 | 27,996 | ||||||||
| Total liabilities and stockholders' equity | $ | 76,646 | $ | 81,941 | ||||||