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VITAL THERAPIES ANNOUNCES THIRD QUARTER 2015

Key Takeaway: VITAL THERAPIES ANNOUNCES THIRD QUARTER 2015 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE SAN DIEGO, November 5, 2015 (GLOBE NEWSWIRE) -- Vital Therapies, Inc. (Nasdaq: VTL), a biotherapeutic company developing ELAD , a cell-based therapy targeting the treatment of liver fai

Full Press Release Details

VITAL THERAPIES ANNOUNCES THIRD QUARTER 2015 FINANCIAL RESULTS
AND PROVIDES CORPORATE UPDATE
SAN DIEGO, November 5, 2015 (GLOBE NEWSWIRE) -- Vital Therapies, Inc. (Nasdaq: VTL), a biotherapeutic company developing ELAD , a cell-based therapy targeting the treatment of liver failure, today announced results for the third quarter ended September 30, 2015 and provided a corporate update.
"Since we announced in late August that our VTI-208 phase 3 clinical trial had failed to meet its primary and secondary endpoints, we have conducted extensive analyses of the VTI-208 data and now believe we have a better understanding of the appropriate patient population to target with the ELAD System," said Terry Winters, Ph.D., Chief Executive Officer and Co-Chairman of Vital Therapies. "We have used this to design a new phase 3 trial, VTL-308, and have started the process of seeking FDA approval of the trial design and statistical plan and commenced opening clinical sites that we anticipate will be mostly the high enrolling sites from VTI-208. We are excited about the path forward for ELAD."
Key Recent Developments
15010 Avenue of Science, San Diego, California, USA 92128
Tel 858.673.6840 Fax 858-673-6843
Third Quarter 2015 Financial Results
Cash and cash equivalents at September 30, 2015, totaled $59.8 million compared to $102.2 million at December 31, 2014.
Results of Operations
Three Months Ended September 30, 2015
The Company reported a net loss of $12.3 million for the quarter ended September 30, 2015, which compared with a net loss of $12.8 million for the same prior year period. This resulted in a net loss attributable to common stockholders of $0.51 per share for the three months ended September 30, 2015, as compared to a net loss of $0.59 per share for the corresponding period in 2014, on both a basic and diluted basis. These per share figures are based on weighted-average common shares outstanding of 24,052,481 shares and 21,759,061 shares, respectively, with the increase in common shares outstanding in 2014 resulting from the Company's follow-on offering in the fourth quarter of 2014.
Total operating expenses for the three months ended September 30, 2015 were $12.3 million as compared to $12.8 million for the comparable period of 2014. Research and development expenses decreased to $9.6 million during the three months ended September 30, 2015 as compared to $10.2 million in the three months ended September 30, 2014. This was primarily due to a reduction in clinical trial activity in comparison to the prior year period. General and administrative expenses were $2.7 million for the three months ended September 30, 2015, up from $2.6 million for the comparable period of 2014.
Upcoming Investor Presentation
Additionally, the Company will be presenting at the 24th Annual Credit Suisse Healthcare Conference in Scottsdale, AZ on Tuesday, November 10, 2015 at 3:30 PM Mountain Time (5:30 PM ET).
Conference Call Details
Vital Therapies will host a conference call to discuss these results and provide a corporate update today, November 5, 2015, at 4:30 p.m. ET, which will be open to the public. The conference call dial-in numbers are (855) 765-5682 for domestic callers and (919) 825-3204 for international callers. The conference ID number for the call is 57542661. Participants may access the live webcast via a link on the Vital Therapies website in the Investor Relations section under "Events" at: http://ir.vitaltherapies.com/.
For those unable to dial in at the designated time, a conference call replay will be available for one week following the conference call, from approximately 7:30 p.m. ET on November 5, 2015 to 11:59 p.m. ET on November 12, 2015. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 57542661. Additionally, an archive of the webcast will be available on the Company's website for 90 days.
MELD (Model of End Stage Liver Disease) score was developed by clinicians at Mayo Clinic in Rochester, MN as an algorithm of three clinical laboratory measurements to yield a single uniformly accepted score to predict the probability of 90-day survival of chronic liver disease patients and thereby prioritize them for liver transplant. After rigorous empirical evaluation of hundreds of such patients, the clinicians concluded that no single laboratory measurement predicted survival in chronic liver disease, but that a complex algorithm of bilirubin, creatinine and INR gave a reliable estimate of survival probability.
MELD score has since been validated for predicting 90-day survival in other types of liver disease including acute alcoholic hepatitis. Details on MELD score can be found in a paper published in Hepatology (2005) titled "MELD Accurately Predicts Mortality in Patients With Alcoholic Hepatitis" (Winston Dunn, Laith H. Jamil, Larry S. Brown, Russell H. Wiesner, W. Ray Kim, K. V. Narayanan Menon, Michael Malinchoc, Patrick S. Kamath, and Vijay Shah). For reference, normal people with no liver disease have MELD scores of about 6 and the average MELD at liver transplant in the U.S. is about 24. High MELD scores are associated with high mortality. For example, at a MELD score of 26 (median MELD of the 60-subject post-hoc subset population targeted for VTL-308), the Dunn et al paper would predict that the patient has a 47% probability of death within 90 days. At a MELD score of 30, the upper limit in the proposed VTL-308 trial, the Dunn et al paper would predict that the patient has a 62% probability of death within 90 days.
About VTI-208 and VTI-208E
VTI-208 was a phase 3 randomized, controlled, open-label trial, evaluating the ELAD System in subjects with AILD. The primary endpoint was overall survival through at least 91 days assessed using the Kaplan Meier statistical method, and the secondary endpoint was proportion of survivors at study days 28 and 91. The trial enrolled 203 subjects over 22 months with 96 subjects randomized to the treated group and 107 randomized to the control group. VTI-208E, an extension study, assesses subject outcomes for five years after enrollment in VTI-208. Results of the VTI-208 clinical trial, incorporating VTI-208E survival data through July 30, 2015, showed that the trial failed to reach its primary or secondary endpoints.
About Vital Therapies, Inc.
Vital Therapies, Inc. is a biotherapeutic company developing a cell-based therapy targeting the treatment of liver failure. The Company's ELAD System is an extracorporeal human allogeneic cellular liver therapy currently in phase 3 clinical trials. Vital Therapies, Inc. is based in San Diego, California. Vital Therapies and ELAD are trademarks of Vital Therapies, Inc.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements concerning or implying the timing and conduct of our clinical trials, including the number of patients and timing of patient enrollment, site openings, data release, accomplishment and timing of certain development goals including regulatory determinations and filings, possible mechanism of action for ELAD and our projected cash runway. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance and you are cautioned not to place undue reliance on these forward-looking statements. Risks and uncertainties include, but are not limited to, the success or failure of our clinical trials and development programs; whether a single phase 3 clinical trial will be sufficient to support FDA approval of a biologics license application or whether the FDA will require us to conduct additional clinical trials; difficulty obtaining regulatory approval in the United States or Europe, in particular for a combination product and open-label clinical trials; whether or when we begin building any significant commercial infrastructure; our limited experience in conducting pivotal clinical trials and significant issues regarding our clinical trials, including, but not limited to, the successful opening and the continued participation of clinical sites and their ongoing adherence to protocols, assumptions regarding enrollment rates, timing and availability of subjects meeting inclusion and exclusion criteria, changes to protocols or regulatory requirements, the ability to comply with and meet applicable laws and regulations, and unexpected adverse events or safety issues; and the sufficiency of funding. There can be no assurance that data from any of our clinical trials will be sufficient to support an application for marketing in any country or that any such application will ever be approved. These and other risks regarding our business are described in detail in our Securities and Exchange Commission filings, including in our Annual Report on Form 10-K for the year ended December 31, 2014 and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2015. Additional information will also be set forth in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2015 to be filed with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Vital Therapies, Inc. disclaims any obligation to update these statements except as may be required by law.
Vital Therapies, Inc.
Vice President, Investor Relations and Business Development
Vital Therapies, Inc.
Condensed Consolidated Balance Sheets
(unaudited, in thousands)
September 30, 2015 December 31, 2014
Cash and cash equivalents $ 59,754 $ 102,238
Other current assets 2,855 2,578
Property and equipment, net 4,163 3,068
Other assets 171 198
Total assets $ 66,943 $ 108,082
Accounts payable and other accrued liabilities $ 8,119 $ 10,278
Long-term liabilities 146 241
Stockholders' equity 58,678 97,563
Total liabilities and stockholders' equity $ 66,943 $ 108,082
Vital Therapies, Inc.
Condensed Consolidated Statements of Operations
(unaudited and in thousands, except per share data)
Three Months Ended September 30, Nine Months Ended September 30,
2015 2014 2015 2014
Operating expenses:
Research and development $ 9,646 $ 10,244 $ 32,945 $ 28,589
General and administrative 2,689 2,566 9,286 7,736
Total operating expenses 12,335 12,810 42,231 36,325
Loss from operations (12,335 ) (12,810 ) (42,231 ) (36,325 )
Revaluation of future purchase rights liabilities and other income (expense), net 35 12 67 2,613
Net loss (12,300 ) (12,798 ) (42,164 ) (33,712 )
Accretion to redemption value and amortization of deemed dividend on preferred stock - - - (9,154 )
Net loss attributable to common
stockholders $ (12,300 ) $ (12,798 ) $ (42,164 ) $ (42,866 )
Net loss per share attributable to common stockholders, basic and diluted $ (0.51 ) $ (0.59 ) $ (1.76 ) $ (3.18 )
Weighted-average common shares
outstanding, basic and diluted 24,025,481 21,759,061 23,998,396 13,483,813
Last updated: Nov 5, 2015