Press Release
Ocular Therapeutix™ Reports Third Quarter 2015 Financial Results
Advances in Clinical Programs Include NDA Submission for DEXTENZA™ (sustained release dexamethasone, 0.4mg) for the Treatment of Post-Surgical Ocular Pain
Results Reported for Phase 3 Allergic Conjunctivitis and Phase 2b Glaucoma Programs
Conference Call Today at
“Our product development programs advanced meaningfully during the third
quarter with an NDA submission to the
Clinical and Corporate Updates during the Third Quarter and Anticipated Near-Term Milestones for Key Development Programs
DEXTENZA for the treatment of post-surgical ocular inflammation and pain
-
An NDA for DEXTENZA for a post-surgical ocular pain indication was
submitted in
September 2015 . -
A third Phase 3 clinical trial for DEXTENZA for post-surgical ocular
inflammation and pain was initiated in
October 2015 . -
Subject to obtaining favorable results in the third Phase 3 trial and
approval of the NDA for post-surgical ocular pain by the
FDA , the Company intends to submit an NDA supplement for DEXTENZA in the second half of 2016 aiming to broaden its label to include the post-surgical inflammation indication.
DEXTENZA for the treatment of allergic conjunctivitis and inflammatory dry eye disease
- DEXTENZA successfully met the primary endpoint for the treatment of ocular itching associated with allergic conjunctivitis in a first Phase 3 clinical trial. There was a statistically significant difference (p<0.0001) in the mean scores between the DEXTENZA treatment group and the placebo group for ocular itching at all three time points measured on day 7 post-insertion of the drug product or placebo. The difference in the scores for ocular itching between the DEXTENZA group and the placebo group was greater than 0.5 units at all time points on day 7 post-insertion and was greater than 1 unit at a majority of the time points on day 7 post-insertion, in each case as measured on a five-point scale. The other primary endpoint of conjunctival redness was not met. Though this endpoint has typically been included in Phase 3 trials for allergic conjunctivitis, most drugs currently marketed for the treatment of allergic conjunctivitis are indicated for ocular itching only.
-
Since the
FDA typically requires two Phase 3 trials to support each ophthalmic indication, the Company plans to initiate a second Phase 3 clinical trial before the end of 2015. If the primary endpoint for ocular itching is met in this second Phase 3 trial, the Company plans to seek approval from theFDA for DEXTENZA for this indication. The Phase 3 trial was conducted byOra, Inc. using their proprietary modified Ora-CAC® (Conjunctival Allergen Challenge) model. This model was developed by Ora to assess the longer therapeutic effect of a one-time administered sustained release drug product. Ora has conducted many of the clinical trials for ophthalmic drugs that have been approved by theFDA . - DEXTENZA is also being investigated in an exploratory Phase 2 clinical trial for the treatment of inflammatory dry eye disease. Topline results are expected by year-end 2015. This study was not powered for statistical significance but was designed to explore which signs or symptoms would be appropriate to include in the design of a future clinical study that can evaluate efficacy of DEXTENZA or other molecules in a sustained release product as a potential therapy for dry eye disease.
OTX-TP (sustained release travoprost) product candidate for the treatment of glaucoma
- Topline results from a Phase 2b clinical trial were announced for the Company’s OTX-TP product candidate for the treatment of glaucoma and ocular hypertension, showing clinically meaningful intraocular pressure (IOP) reduction out to day 90 and improvement in depot retention. Based on safety results available to date, patients in the trial treated with OTX-TP did not experience any hyperemia-related adverse events, which is a common side effect caused by currently marketed topical glaucoma products.
- The Phase 2b trial was designed to further assist in the Phase 3 clinical study design including estimating treatment effect relative to timolol, determining the duration of effect up to 3 months, and assessing patients’ ability to self-assess the presence of the drug product.
-
In the Phase 2b trial, OTX-TP achieved consistent IOP lowering with
the same drug release rate as in the Phase 2a clinical trial of
OTX-TP. The duration of effect as measured by the clinically
meaningful reduction of IOP was in the 4.5 to 5.7 mmHg range, observed
at
8 am out to 90 days. The comparator timolol arm lowered IOP in the 6.4 to 7.6 mmHg range. This difference between the two arms could be due to the presence of the placebo plug which enables longer retention of timolol drops on the ocular surface. -
Prior to initiating its Phase 3 clinical program for OTX-TP in
glaucoma, the Company plans to conduct further studies to determine
the effect of the placebo depot, incorporate findings from
non-significant risk studies to its product design and discuss
alternative clinical trial designs, more representative of real world
use, with the
FDA . At day 60, which was the primary efficacy measure, in the intent-to-treat (ITT) population the OTX-TP group had an IOP lowering effect of 4.8 mmHg, compared with IOP lowering of 6.4 mmHg for the timolol arm. At day 90, which was a secondary efficacy measure, the OTX-TP group had an IOP lowering effect of 5.2 mmHg, compared with an IOP lowering effect of 7.3 mmHg in the timolol arm. - In a post-hoc analysis that used the longer washout baseline and excluded approximately 10% of patients who were on more than one IOP lowering medication prior to the study, the difference between the groups was observed to have been narrowed at day 60; 5.3 mmHg for OTX-TP group compared to 6.2 mmHg for timolol group.
- In summary, the Phase 2b glaucoma trial was designed to assist the Company in its Phase 3 clinical design. The Company continues to believe that a sustained release therapy for the treatment of glaucoma has the potential to significantly improve patient compliance, one of the most challenging issues with existing eye drop therapies. After examining the results of the post-hoc analysis, the Company will likely continue to focus on a 90-day product, especially since a clinically relevant IOP lowering effect through day 90 was observed. The Company expects the commencement of a Phase 3 program of OTX-TP in the second half of 2016 versus prior guidance of the first half of 2016.
-
Amar Sawhney , Ph.D., Chairman, President and Chief Executive Officer ofOcular Therapeutix will be presenting at the Ophthalmic Innovation Symposium (OIS) meeting onNovember 12, 2015 inLas Vegas . At the AAO meeting to be held inLas Vegas fromNovember 14-17, 2015 , the Company will have several presentations highlighting DEXTENZA and the ReSure® Sealant.
Expansion and Strengthening of the Board of Directors
The Company strengthened its Board of Directors with two appointments:
-
Jeffrey S. Heier , M.D., a prominent retinal specialist atOphthalmology Consultants ofBoston and a leading retinal clinical researcher of new treatments for diseases of the back of the eye, including macular degeneration, diabetic macular edema, and venous occlusive disease; and -
James O’Shea, who has substantial experience in successfully managing
commercial stage pharmaceutical and biotechnology companies. Jim was
the President and Chief Operating Officer at
Sepracor, Inc. , where he led the launch and commercialization of Xepenex® and Lunesta®. He also served as Vice Chairman at Sepracor and was the Senior Vice President of Sales & Marketing at Zeneca.
Third Quarter 2015 Financial Results
-
As of
September 30, 2015 , cash and cash equivalents and marketable securities totaled$113.6 million . Cash used in operating activities was$9.7 million and$25.1 million for the three and nine month periods endedSeptember 30, 2015 , respectively. There was$15.0 million in outstanding debt as ofSeptember 30, 2015 . -
Ocular Therapeutix reported a net loss of approximately$11.5 million , or$(0.47) per share, for the quarter endedSeptember 30, 2015 , compared to a net loss of$7.3 million , or$(0.48) per share, for the quarter endedSeptember 30, 2014 . The third quarter 2015 results include$1.2 million in non-cash charges for stock-based compensation compared to$0.6 million in the third quarter of 2014. -
Total operating expenses for the quarter ended
September 30, 2015 were$11.6 million as compared to$6.9 million for the quarter endedSeptember 30, 2014 . Research and development (R&D) expenses for the quarter endedSeptember 30, 2015 were$8.3 million , compared to$4.5 million for the quarter endedSeptember 30, 2014 . The increase is primarily related to personnel costs and clinical trials of DEXTENZA and OTX-TP product candidates as well as preclinical development of the Company’s anti-VEGF and TKI programs for the treatment of wet age-related macular degeneration and other back of the eye diseases. -
Ocular Therapeutix generated$0.4 million in revenue during the three months endedSeptember 30, 2015 from product sales of ReSure® Sealant and from collaborations with corporate partners. -
As of
October 31, 2015 , there were approximately 24.7 million shares issued and outstanding.
Conference Call & Webcast Information
Members of the
The live webcast can be accessed by visiting the investor 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 conference call. The conference ID
number for the live call will be 71925202. 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 statements about the
development of the Company’s product candidates, such as the Company’s
plans for regulatory submissions and the design and conduct of a third
clinical trial of DEXTENZA™ for post-surgical inflammation and pain, the
timing and conduct of the Company’s additional development work and
clinical trials of OTX-TP for the treatment of glaucoma and ocular
hypertension, the timing and conduct of a second Phase 3 clinical trial
of DEXTENZA for the treatment of allergic conjunctivitis and the
Company’s exploratory Phase 2 clinical trial of DEXTENZA for the
treatment of inflammatory dry eye disease, the ongoing development of
the Company’s sustained release hydrogel depot technology, the
advancement of the Company's other product candidates, the potential
utility of any of the Company’s product candidates and other statements
containing the words "anticipate," "believe," "estimate," "expect,"
"intend", "goal," "may", "might," "plan," "predict," "project,"
"target," "potential," "will," "would," "could," "should," "continue,"
and similar expressions, constitute forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by such
forward-looking statements as a result of various important factors.
Such forward-looking statements involve substantial risks and
uncertainties that could cause the Company’s clinical development
programs, future results, performance or achievements to differ
significantly from those expressed or implied by the forward-looking
statements. Such risks and uncertainties include, among others, those
related to the timing and costs involved in commercializing ReSure®
Sealant, the initiation and conduct of clinical trials, availability of
data from clinical trials and expectations for regulatory submissions
and approvals, the Company’s scientific approach and general development
progress, the availability or commercial potential of the Company’s
product candidates, the sufficiency of cash resources and need for
additional financing or other actions and other factors discussed in the
“Risk Factors” section contained in the Company’s quarterly and annual
reports on file with the
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Ocular Therapeutix, Inc.
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Three Months Ended |
Nine Months Ended |
||||||||||||||||||||||||||||
| 2015 | 2014 | 2015 | 2014 | ||||||||||||||||||||||||||
| Revenue: | |||||||||||||||||||||||||||||
| Product revenue | $ | 388 | $ | 143 | $ | 960 | $ | 267 | |||||||||||||||||||||
| Collaboration revenue | 41 | — | 354 | — | |||||||||||||||||||||||||
| Total revenue: | 429 | 143 | 1,314 | 267 | |||||||||||||||||||||||||
| Operating expenses: | |||||||||||||||||||||||||||||
| Cost of product revenue | 91 | 32 | 227 | 61 | |||||||||||||||||||||||||
| Research and development | 8,263 | 4,482 | 19,725 | 13,732 | |||||||||||||||||||||||||
| Selling and marketing | 798 | 479 | 2,709 | 1,324 | |||||||||||||||||||||||||
| General and administrative | 2,451 | 1,926 | 6,575 | 4,697 | |||||||||||||||||||||||||
| Total operating expenses | 11,603 | 6,919 | 29,236 | 19,814 | |||||||||||||||||||||||||
| Loss from operations | (11,174 |
) |
|
(6,776 |
) |
|
(27,922 |
) |
|
(19,547 |
) |
|
|||||||||||||||||
| Other income (expense): | |||||||||||||||||||||||||||||
| Interest income | 53 | 5 | 121 | 7 | |||||||||||||||||||||||||
| Interest expense | (406 |
) |
|
(412 |
) |
|
(1,316 |
) |
|
(712 |
) |
|
|||||||||||||||||
| Other income (expense), net | 3 | (111 |
) |
|
6 | (442 |
) |
|
|||||||||||||||||||||
| Total other expense, net | (350 |
) |
|
(518 |
) |
|
(1,189 |
) |
|
(1,147 |
) |
|
|||||||||||||||||
| Net loss | (11,524 |
) |
|
(7,294 |
) |
|
(29,111 |
) |
|
(20,694 |
) |
|
|||||||||||||||||
| Accretion of redeemable convertible preferred stock to redemption value | — | — | — | (11 | ) | ||||||||||||||||||||||||
| Net loss attributable to common stockholders | $ | (11,524 |
) |
|
$ | (7,294 |
) |
|
$ | (29,111 |
) |
|
$ | (20,705 |
) |
|
|||||||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.47 |
) |
|
$ | (0.48 |
) |
|
$ | (1.28 |
) |
|
$ | (2.93 |
) |
|
|||||||||||||
| Weighted average common shares outstanding, basic and diluted | 24,713,597 | 15,165,612 | 22,757,646 | 7,068,399 | |||||||||||||||||||||||||
| Comprehensive loss: | |||||||||||||||||||||||||||||
| Net loss | $ | (11,524 | ) | $ | (7,294 | ) | $ | (29,111 | ) | $ | (20,694 | ) | |||||||||||||||||
| Other comprehensive loss: | |||||||||||||||||||||||||||||
| Unrealized loss on marketable securities | (8 | ) | — | (16 | ) | — | |||||||||||||||||||||||
| Total other comprehensive loss | (8 | ) | — | (16 | ) | — | |||||||||||||||||||||||
| Total comprehensive loss | $ | (11,532 |
) |
|
$ | (7,294 |
) |
|
$ | (29,127 |
) |
|
$ | (20,694 |
) |
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OCULAR THERAPEUTIX, INC. |
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September 30, |
December 31, |
||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 41,198 | $ | 37,393 | |||||||
| Marketable securities | 72,445 | 37,435 | |||||||||
| Accounts receivable | 189 | 329 | |||||||||
| Inventory | 147 | 133 | |||||||||
| Prepaid expenses and other current assets | 1,919 | 893 | |||||||||
| Total current assets | 115,898 | 76,183 | |||||||||
| Property and equipment, net | 3,193 | 1,782 | |||||||||
| Restricted cash | 228 | 228 | |||||||||
| Total assets | $ | 119,319 | $ | 78,193 | |||||||
| Liabilities and Stockholders’ Equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 1,624 | $ | 1,316 | |||||||
| Accrued expenses | 3,591 | 3,016 | |||||||||
| Deferred revenue | 83 | 188 | |||||||||
| Notes payable, net of discount, current | 5,883 | 1,354 | |||||||||
| Total current liabilities | 11,181 | 5,874 | |||||||||
| Deferred rent, long-term | 81 | 112 | |||||||||
| Notes payable, net of discount, long-term | 9,249 | 13,511 | |||||||||
| Total liabilities | 20,511 | 19,497 | |||||||||
| Commitments and contingencies | |||||||||||
| Stockholders’ equity: | |||||||||||
| Preferred stock, $0.0001 par value; 5,000,000 authorized at September 30, 2015 and December 31, 2014; no shares issued or outstanding at September 30, 2015 and December 31, 2014 | — | — | |||||||||
| Common stock, $0.0001 par value; 100,000,000 shares authorized at September 30, 2015 and December 31, 2014; 24,730,061 and 21,333,507 shares issued and outstanding at September 30, 2015 and December 31, 2014, respectively | 2 | 2 | |||||||||
| Additional paid-in capital | 217,361 | 148,122 | |||||||||
| Accumulated deficit | (118,539 | ) | (89,428 | ) | |||||||
| Accumulated other comprehensive loss | (16 | ) | — | ||||||||
| Total stockholders’ equity | 98,808 | 58,696 | |||||||||
| Total liabilities and stockholders’ equity | $ | 119,319 | $ | 78,193 | |||||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20151110006936/en/
Source:
Ocular Therapeutix, Inc.
Investors
Brad Smith
Chief
Financial Officer
bsmith@ocutx.com
or
Burns
McClellan on behalf of Ocular Therapeutix
Kimberly Minarovich,
212-213-0006
kminarovich@burnsmc.com
or
Media
Ocular
Therapeutix, Inc.
Scott Corning
Vice President of Sales and
Marketing
scorning@ocutx.com
