Synta Pharmaceuticals Reports Fourth Quarter and Full Year 2008 Financial Results
In the fourth quarter of 2008, the Company recorded
As of
In the first quarter of 2009, the Company achieved and was paid a
2009 Goals
“With a diversified pipeline, near-term inflection points, and a
two-year or greater cash position, Synta is well-positioned despite the
disappointing results from the Phase 3 SYMMETRY(SM) trial of
elesclomol in metastatic melanoma,” said
“In addition to elesclomol, we have two drugs in clinical development, three programs in preclinical development, and others in research stages,” continued Dr. Bahcall. “It has always been our strategy to maintain a strong cash position through the careful management of our portfolio of programs, including the timing and choice of partnering to generate non-dilutive capital. This strategy has led to our current position of numerous programs with near-term milestones and the resources with which to get them there. We are excited in particular by the results to date from our STA-9090 program, which have generated strong interest from investigators across a broad range of potential cancer indications. We have set ambitious goals for this program and our other drug candidates in 2009.”
Dr. Bahcall said that the key priorities for Synta in 2009 are to:
- Complete the analysis of the results of the SYMMETRY trial with the goal of determining a possible path forward for elesclomol;
-
Advance our STA-9090 program by:
- Completing our on-going Phase 1 trials in solid tumors;
- Advancing our Phase 1/2 twice-a-week dosing trial in hematologic cancers;
- Initiating a Phase 2 once-a-week dosing trial in hematologic cancers;
- Initiating additional Phase 2 trials in solid tumor cancers;
- Advance our Hsp90 inhibitor research effort, including follow-on and oral compounds;
- Complete enrollment and analyze data for our Phase 2a clinical trial of apilimod in rheumatoid arthritis;
-
Advance the lead compound in our CRACM program, which is partnered
with
Roche , targeting Phase 1 start in 2010; - Advance our CRACM research effort, including identifying new compounds for preclinical development in 2010;
- Identify at least one new partnership opportunity.
SYMMETRY Update
An analysis of the early results of the Phase 3 SYMMETRY trial, which was suspended in February after a meeting of an independent Data Monitoring Committee (DMC), is currently underway.
“To date, we have not identified any specific target organ toxicities or
adverse events related to elesclomol that might explain the previously
reported finding from an interim analysis, which showed an imbalance of
deaths between the two arms in the Phase 3 SYMMETRY trial,” said
2008 and Recent Accomplishments
Synta made significant progress in advancing its diverse pipeline of small molecule drug candidates:
-
Elesclomol (oxidative stress inducer):
- Concluded enrollment in the pivotal, Phase 3 clinical trial (SYMMETRY) in approximately 150 centers in 15 countries;
- Initiated a prostate and a monotherapy trial with the sodium salt formulation;
-
Received
$40 million in milestone payments from our partner, GSK in 2008, and an additional$10 million in early 2009; - Made substantial progress in elucidating the mechanism of action and generating productive academic collaborations to further explore the science underlying this mechanism.
-
STA-9090 (Hsp90 inhibitor):
- Initiated and advanced two solid-tumor dose-escalating trials, which have shown encouraging signs of clinical and biological activity;
- Initiated a Phase 1/2 trial in hematologic cancers;
- Initiated preclinical development of a follow-on compound;
- Initiated lead optimization for orally-bioavailable compounds;
- Generated productive academic collaborations that have demonstrated certain advantages of STA-9090, which will continue to lead to peer-reviewed publications and scientific and medical meeting presentations, and are assisting in the initiation of a number of important exploratory clinical trials.
-
STA-9584 (vascular disrupting agent):
- Currently in preclinical development.
-
Apilimod (IL12/IL23 inhibitor):
- Continued enrolling patients at higher dose level in a Phase 2a rheumatoid arthritis clinical trial, following promising signs of biological and clinical activity at a lower dose level.
-
Ion channel platform (CRACM) and
Roche agreement:- Platform for developing small molecule, targeted inhibitors of a key pathway regulating immune cell function; potential applications include rheumatoid arthritis, asthma, chronic obstructive pulmonary disease (COPD), allergy, transplant rejection, and other autoimmune diseases and inflammatory conditions;
-
Conducted an in-depth partnership effort resulting in a favorable
agreement with
Roche . Agreement provides for a$16 million up-front payment; reimbursement for all research, preclinical, and clinical costs; substantial milestone payments; and royalties on sales from any resulting approved, marketed products; - Initiated preclinical development of lead orally-bioavailable compound, which has demonstrated potent in vivo inhibition of key pro-inflammatory cytokines.
Financial Results
In the fourth quarter of 2008, the Company recorded
The Company reported a net loss attributable to common stockholders of
The Company reported a net loss attributable to common stockholders of
Research and development (R&D) expenses were
General and administrative expenses (G&A) were
More detailed financial information and analysis may be found in the
Company's Annual Report on Form 10-K, which was filed with the
Conference Call
Management will conduct a conference call at
The call can also be accessed by dialing (877) 407-8035 or (201)
689-8035 prior to the start of the call. For those unable to join the
live conference call, a replay will be available from
About
Safe Harbor Statement
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Synta Pharmaceuticals Corp. Condensed Consolidated Statements of Operations (in thousands, except share and per share amounts) |
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Three months ended
December 31, |
Twelve months ended
December 31, |
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2008 | 2007 | 2008 | 2007 | |||||||||
Collaboration revenues: | ||||||||||||
License and milestone revenue | $ | 3,018 | $ | 743 | $ | 8,513 | $ | 743 | ||||
Cost sharing reimbursements | (2,382) | - | (5,898) | - | ||||||||
Total collaboration revenues | 636 | 743 | 2,615 | 743 | ||||||||
Operating expenses: | ||||||||||||
Research and development | 23,031 | 13,326 | 81,581 | 52,025 | ||||||||
General and administrative | 3,470 | 3,761 | 14,742 | 14,934 | ||||||||
Total operating expenses | 26,501 | 17,087 | 96,323 | 66,959 | ||||||||
Loss from operations | (25,865) | (16,344) | (93,708) | (66,216) | ||||||||
Other income: | ||||||||||||
Investment income, net | (88) | 820 | 1,090 | 2,721 | ||||||||
Net loss | (25,953) | (15,524) | (92,618) | (63,495) | ||||||||
Convertible preferred stock beneficial conversion charge | - | - | - | 58,585 | ||||||||
Net loss attributable to common stockholders |
$ | (25,953) | $ | (15,524) | $ | (92,618) | $ | (122,080) | ||||
Basic and diluted weighted average common shares outstanding | 33,741,960 | 33,708,862 | 33,735,579 | 32,466,006 | ||||||||
Basic and diluted net loss attributable to common stockholders per share | $ | (0.77) | $ | (0.46) | $ | (2.75) | $ | (3.76) |
Synta Pharmaceuticals Corp. Condensed Consolidated Balance Sheets Data (in thousands) |
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December 31, |
December 31, |
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Assets | ||||||
Cash, cash equivalents, marketable securities | $ | 73,563 | $ | 115,577 | ||
Collaboration receivable | 16,000 | - | ||||
Other current assets | 1,658 | 1,420 | ||||
Property, plant and equipment, net | 5,929 | 5,576 | ||||
Other non-current assets | 103 | 76 | ||||
Total assets | $ | 97,253 | $ | 122,649 | ||
Liabilities and Equity | ||||||
Current liabilities | $ | 33,323 | $ | 20,772 | ||
Long-term liabilities | 122,721 | 76,981 | ||||
Stockholders’ (deficit) equity | (58,791) | 24,896 | ||||
Total liabilities and stockholders’ (deficit) equity |
$ | 97,253 | $ | 122,649 |
Source:
Synta Pharmaceuticals Corp.
Rob Kloppenburg, 781-541-7125