Press Release
Ocular Therapeutix™ Reports Second Quarter 2017 Financial Results and Provides Corporate Update
Conference Call Today at
“This is an important time for
Recent Updates and Anticipated Near-Term Milestones Across Key Development Programs
DEXTENZA™ for the treatment of post-surgical ocular inflammation and pain
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In
July 2017 ,Ocular Therapeutix received a Complete Response Letter (CRL) from theU.S. Food and Drug Administration (FDA ), regarding resubmission of a New Drug Application (NDA) for DEXTENZA™ (dexamethasone insert) 0.4mg for the treatment of ocular pain following ophthalmic surgery. The CRL did not identify any efficacy or safety concerns with respect to the clinical data for DEXTENZA provided in the NDA, nor any need for additional clinical trials for the NDA approval.
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The CRL from the
FDA referred to deficiencies in manufacturing processes and analytical testing related to manufacture of drug product for commercial production identified in an outstanding FormFDA -483. The Form FDA-483 was received following anFDA pre-NDA approval re-inspection of theOcular Therapeutix manufacturing facility that was completed inMay 2017 .Ocular Therapeutix plans to produce additional commercial batches of DEXTENZA and submit data from these batches to theFDA with the resubmission of its NDA.
OTX-TP (travoprost insert) for the treatment of glaucoma and ocular hypertension
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Ocular Therapeutix continues to enroll patients in its first Phase 3 clinical trial for OTX-TP (travoprost insert) for the treatment of glaucoma and ocular hypertension. Topline efficacy data from the trial is expected in the second half of 2018.-
The primary efficacy endpoint is statistically superior reduction
of intraocular pressure (IOP) from baseline with OTX-TP compared
to placebo at three diurnal time points of
8am ,10am , and4pm , at intervals of 2, 6 and 12 weeks following insertion. - The Phase 3 study design does not include a timolol comparator or validation arm, and does not have active or placebo eye drops administered in either arm.
- The Company plans to initiate its second Phase 3 clinical trial with OTX-TP for the treatment of glaucoma and ocular hypertension in 2017.
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The primary efficacy endpoint is statistically superior reduction
of intraocular pressure (IOP) from baseline with OTX-TP compared
to placebo at three diurnal time points of
OTX-TIC (travoprost intracameral injection) for the treatment of moderate to severe glaucoma and ocular hypertension
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Ocular Therapeutix is developing an intracameral product candidate, OTX-TIC, which is a bioresorbable travoprost-containing hydrogel depot delivered via a fine-gauge needle injection. The Company is developing OTX-TIC to potentially address the need for a higher level of IOP reduction for patients who have moderate to severe glaucoma.- The Company plans to initiate a pilot human clinical trial in 2017 to assess safety and obtain initial efficacy data.
Sustained release intravitreal depots for the treatment of serious retinal diseases
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Ocular Therapeutix is engaged in the preclinical development of its extended release intravitreal tyrosine kinase inhibitor (TKI) depot (OTX-TKI) using the Company’s proprietary bioresorbable hydrogel fiber technology.-
At the ARVO Annual Meeting in
May 2017 ,Ocular Therapeutix presented preclinical data, demonstrating for the first time the ability to deliver an efficacious dose of TKI to the posterior segment of the eye for the treatment of VEGF-induced retinal leakage for an extended duration of up to six months. - The Company expects to enter Phase 1 clinical testing with OTX-TKI by the end of 2017.
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At the ARVO Annual Meeting in
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In partnership with
Regeneron Pharmaceuticals ,Ocular Therapeutix also continues to advance the development of an extended release hydrogel-based formulation of Regeneron’s protein-based anti-vascular endothelial growth factor (VEGF) trap, aflibercept, for the treatment of wet age-related macular degeneration (wet AMD) and other serious retinal diseases.
Second Quarter 2017 Financial Results
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As of
June 30, 2017 , cash, cash equivalents and marketable securities totaled$66.0 million . Cash used in operating activities was$11.3 million in the second quarter of 2017, compared to$9.8 million for the second quarter of 2016. The Company expects that cash, cash equivalents and marketable securities will be sufficient to fund operating expenses, debt service obligations and capital expenditures through the third quarter of 2018. -
Ocular Therapeutix reported a net loss of approximately$(18.7) million , or$(0.64) per share, for the quarter endedJune 30, 2017 , compared to a net loss of$(11.4) million , or$(0.46) per share, for the quarter endedJune 30, 2016 . The second quarter 2017 results include$2.1 million in non-cash charges for stock-based compensation and depreciation compared to$1.7 million in such non-cash charges in the second quarter of 2016. -
Total costs and operating expenses for the quarter ended
June 30, 2017 were$18.8 million , as compared to$11.5 million for the quarter endedJune 30, 2016 . Research and development expenses for the quarter endedJune 30, 2017 were$8.1 million , compared to$7.0 million for the quarter endedJune 30, 2016 . The Company continues to advance the clinical and preclinical development of its hydrogel platform technology and its portfolio of drug product candidates. -
Ocular Therapeutix generated$0.4 million in revenue during the three-month period endedJune 30, 2017 from product sales of ReSure® Sealant. -
As of
June 30, 2017 , there were approximately 29.1 million shares issued and outstanding.
Conference Call & Webcast Information
Members of the
The live webcast can be accessed by visiting the Investors section of
the Company’s website at investors.ocutx.com. Please connect at least 15
minutes prior to the live webcast to ensure adequate time for any
software download that may be needed to access the webcast.
Alternatively, please call 844-464-3934 (U.S.) or 765-507-2620
(International) to listen to the live conference call. The conference ID
number for the live call will be 59980638. An archive of the webcast
will be available until
About Ocular Therapeutix, Inc.
Forward Looking Statements
Any statements in this press
release about future expectations, plans and prospects for the Company
including the development and regulatory status of the Company’s product
candidates, such as the Company’s expectations and plans regarding
product development efforts and regulatory submissions for and the
timing and conduct of clinical trials of DEXTENZA for the treatment of
post-surgical ocular inflammation and pain, including with respect to
the manufacturing deficiencies identified by the
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Ocular Therapeutix, Inc. |
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Statements of Operations and Comprehensive Loss |
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(In thousands, except share and per share data) |
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(Unaudited) |
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| Three Months Ended | Six Months Ended | ||||||||||||||||||||
| June 30, | June 30, | ||||||||||||||||||||
| 2017 | 2016 | 2017 | 2016 | ||||||||||||||||||
| Revenue: | |||||||||||||||||||||
| Product revenue | $ | 438 | $ | 441 | $ | 913 | $ | 857 | |||||||||||||
| Collaboration revenue | — | — | — | 42 | |||||||||||||||||
| Total revenue | 438 | 441 | 913 | 899 | |||||||||||||||||
| Costs and operating expenses: | |||||||||||||||||||||
| Cost of product revenue | 104 | 105 | 219 | 204 | |||||||||||||||||
| Research and development | 8,117 | 6,978 | 14,846 | 14,051 | |||||||||||||||||
| Selling and marketing | 6,832 | 1,492 | 12,859 | 2,881 | |||||||||||||||||
| General and administrative | 3,724 | 2,973 | 7,000 | 5,379 | |||||||||||||||||
| Total costs and operating expenses | 18,777 | 11,548 | 34,924 | 22,515 | |||||||||||||||||
| Loss from operations | (18,339 | ) | (11,107 | ) | (34,011 | ) | (21,616 | ) | |||||||||||||
| Other income (expense): | |||||||||||||||||||||
| Interest income | 113 | 80 | 205 | 167 | |||||||||||||||||
| Interest expense | (468 | ) | (418 | ) | (911 | ) | (836 | ) | |||||||||||||
| Total other expense, net | (355 | ) | (338 | ) | (706 | ) | (669 | ) | |||||||||||||
| Net loss | (18,694 | ) | (11,445 | ) | $ | (34,717 | ) | $ | (22,285 | ) | |||||||||||
| Net loss per share, basic and diluted | $ | (0.64 | ) | $ | (0.46 | ) | $ | (1.22 | ) | $ | (0.90 | ) | |||||||||
| Weighted average common shares outstanding, basic and diluted | 29,026,259 | 24,770,059 | 28,352,348 | 24,761,498 | |||||||||||||||||
| Comprehensive loss: | |||||||||||||||||||||
| Net loss | $ | (18,694 | ) | $ | (11,445 | ) | $ | (34,717 | ) | $ | (22,285 | ) | |||||||||
| Other comprehensive income (loss): | |||||||||||||||||||||
| Unrealized gain on marketable securities | 9 | 10 | 5 | 78 | |||||||||||||||||
| Total other comprehensive income | 9 | 10 | 5 | 78 | |||||||||||||||||
| Total comprehensive loss | $ | (18,685 | ) | $ | (11,435 | ) | $ | (34,712 | ) | $ | (22,207 | ) | |||||||||
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Balance Sheets |
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(In thousands, except share and per share data) |
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(Unaudited) |
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| June 30, | December 31, | |||||||||||
| 2017 | 2016 | |||||||||||
| Assets | ||||||||||||
| Current assets: | ||||||||||||
| Cash and cash equivalents | $ | 63,049 | $ | 32,936 | ||||||||
| Marketable securities | 3,000 | 35,209 | ||||||||||
| Accounts receivable | 211 | 250 | ||||||||||
| Inventory | 90 | 113 | ||||||||||
| Prepaid expenses and other current assets | 1,978 | 1,390 | ||||||||||
| Total current assets | 68,328 | 69,898 | ||||||||||
| Property and equipment, net | 9,619 | 3,313 | ||||||||||
| Restricted cash | 1,728 | 1,728 | ||||||||||
| Total assets | $ | 79,675 | $ | 74,939 | ||||||||
| Liabilities and Stockholders’ Equity | ||||||||||||
| Current liabilities: | ||||||||||||
| Accounts payable | $ | 6,307 | $ | 2,116 | ||||||||
| Accrued expenses and deferred rent | 4,379 | 4,635 | ||||||||||
| Notes payable, net of discount, current | 2,444 | 1,549 | ||||||||||
| Total current liabilities | 13,130 | 8,300 | ||||||||||
| Deferred rent, long-term | 3,146 | 537 | ||||||||||
| Notes payable, net of discount, long-term | 15,374 | 14,094 | ||||||||||
| Total liabilities | 31,650 | 22,931 | ||||||||||
| Commitments and contingencies (Note 11) | ||||||||||||
| Stockholders’ equity: | ||||||||||||
| Preferred stock, $0.0001 par value; 5,000,000 shares authorized at June 30, 2017 and December 31, 2016; no shares issued or outstanding at June 30, 2017 and December 31, 2016 | — | — | ||||||||||
| Common stock, $0.0001 par value; 100,000,000 shares authorized at June 30, 2017 and December 31, 2016; 29,055,460 and 25,024,100 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively | 3 | 3 | ||||||||||
| Additional paid-in capital | 256,618 | 225,889 | ||||||||||
| Accumulated deficit | (208,596 | ) | (173,879 | ) | ||||||||
| Accumulated other comprehensive loss | — | (5 | ) | |||||||||
| Total stockholders’ equity | 48,025 | 52,008 | ||||||||||
| Total liabilities and stockholders’ equity | $ | 79,675 | $ | 74,939 | ||||||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20170808006386/en/
Source:
Investors
Burns McClellan
Steve Klass, 212-213-0006
sklass@burnsmc.com
or
Ocular
Therapeutix
George Migausky
Interim Chief Financial Officer
gmigausky@ocutx.com
or
Media
Ocular
Therapeutix
Scott Corning
Vice President of Marketing &
Commercial Operations
scorning@ocutx.com
