Ocular Therapeutix™ Reports Fourth Quarter and Full Year 2014 Financial Results
Both primary efficacy measures successfully achieved in the first of two Phase 3 clinical trials of OTX-DP for the treatment of post-surgical ocular inflammation and pain
NDA submission for OTX-DP for the treatment of post-surgical ocular inflammation and pain expected in 2Q 2015
Initiation of Phase 3 clinical trials of OTX-DP for the treatment of allergic conjunctivitis expected in the middle of 2015
Phase 2b clinical data on OTX-TP for glaucoma and ocular hypertension anticipated in 4Q 2015
Conference Call Today at
“2014 was an exceptional year for
Clinical Milestones and Corporate Developments
Ocular Therapeutixreported positive topline Phase 3a clinical trial data of its Sustained Release Dexamethasone (OTX-DP) for the treatment of ocular inflammation and pain following cataract surgery in 247 patients, achieving statistically significant improvement both in pain and in the reduction of inflammatory cells. Statistically significant differences were shown in both primary efficacy measures between treatment and control groups, the absence of inflammatory cells at day 14 and the absence of pain at day 8. 33.7% of OTX-DP treated patients showed an absence of inflammatory cells in the anterior chamber of the eye on day 14 compared to 14.6% of those receiving placebo (p=0.0015). In addition, 76.1% of patients receiving OTX-DP reported absence of pain in the study eye at day 8 compared to 36.1% of those patients in the placebo group (p<0.0001).
January 2015, the Company initiated patient enrollment in a Phase 2 exploratory clinical trial of OTX-DP for the treatment of inflammatory dry eye disease, expanding the clinical program for its hydrogel technology into a new indication.
November 2014, the Company announced results from a Phase 2 clinical trial for OTX-DP for the treatment of allergic conjunctivitis, achieving a statistically significant therapeutic effect for ocular itching and conjunctival redness at multiple time points with a single dose.
November 2014, the Company initiated patient enrollment in a Phase 2b clinical trial of its Sustained Release Travoprost (OTX-TP) for the treatment of glaucoma and ocular hypertension. The prospective, multicenter, randomized, double-masked, parallel-arm, active controlled study is designed to evaluate 80 patients at 10 clinical sites in the U.S. for the safety and efficacy of OTX-TP as compared to timolol eye drops. Fifty patients have been enrolled thus far, and the Company is on track to complete the trial in the fourth quarter of 2015.
October 2014, the Company signed an early stage feasibility agreement with a fourth biopharmaceutical company to evaluate an oncology drug for ophthalmic indications.
In July and
August 2014, the Company raised net proceeds of approximately $66.4 millionin its IPO of 5,000,000 shares of its common stock and the full exercise of the underwriters' option on an additional 750,000 shares. On July 25, 2014, the Company’s shares began trading on the NASDAQ Global Marketunder the symbol "OCUL".
January 2014, the Company received approval from the U.S. Food and Drug Administration( FDA) to commercialize the ReSure® Sealant in the United States, with an indication for prevention of postoperative fluid egress from incisions with a demonstrated wound leak following cataract surgery. The ReSure® Sealant is the first and only sealant that is FDA-approved for ophthalmic use.
Anticipated Clinical and Regulatory Milestones
- Completion of the Phase 3b clinical trial of OTX-DP for the treatment of ocular inflammation and pain following cataract surgery, with topline results expected by the end March. This is the second of two Phase 3 clinical trials of OTX-DP for this indication.
- Submission of a New Drug Application (NDA) for OTX-DP for the treatment of post-surgical ocular inflammation and pain anticipated in the second quarter of 2015.
- Advancement of feasibility work on the sustained delivery of anti-VEGF drugs in a hydrogel depot for the treatment of back-of-the-eye diseases, including wet age-related macular degeneration, expected in the first half of 2015.
- Completion of enrollment in the Phase 2b clinical trial evaluating OTX-TP for the treatment of glaucoma and ocular hypertension, with data expected in the fourth quarter of 2015.
- Initiation of Phase 3 clinical trials of OTX-DP for the treatment of allergic conjunctivitis expected in the middle of 2015.
- Completion of a Phase 2 exploratory clinical trial of OTX-DP for the treatment of inflammatory dry eye disease, with data expected in the fourth quarter of 2015.
Fourth Quarter and Year Ended
Total operating expenses for the quarter ended
The Company generated
Conference Call & Webcast Information
Members of the
The live webcast and a replay may be accessed by visiting Ocular’s website at investors.ocutx.com. Please connect to the Company's website 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 is 98833560. Please dial in approximately 10 minutes prior to the call. Following the webcast, an archived version of the call will be available for three months.
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 timing and
conduct of the Company’s Phase 3 clinical trials of OTX-DP for the
treatment of post-surgical ocular inflammation and pain, the potential
submission of an NDA for OTX-DP for this indication, the timing and
conduct of the Company's Phase 2b clinical trial of OTX-TP for the
treatment of glaucoma and ocular hypertension, the Company’s Phase 3
clinical trials of OTX-DP for allergic conjunctivitis and the Company’s
Phase 2 exploratory clinical trial of OTX-DP for the treatment of
inflammatory dry eye disease, pre-commercial activities, the advancement
of the Company's earlier stage pipeline, including the timing and
conduct of feasibility studies for the Company’s hydrogel depot
delivering anti-VEGF drugs, future sales of ReSure Sealant 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 Ocular Therapeutix’
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 initiation and conduct of clinical
trials, availability of data from clinical trials and expectations for
regulatory 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, the timing and costs involved
in commercializing ReSure® Sealant and other factors
discussed in the “Risk Factors” section contained in the Company’s most
recent Quarterly Report on Form 10-Q on file with the
|Ocular Therapeutix, Inc.|
|Statement of Operations and Comprehensive Loss|
|(In thousands, except share and per share data)|
|Three Months ended||Year ended|
|December 31,||December 31,|
|Cost of product revenue||30||-||91||-|
|Research and development||5,148||2,842||18,880||10,517|
|Selling and marketing||658||197||1,982||625|
|General and administrative||2,216||380||6,913||1,761|
|Total operating expenses||8,052||3,419||27,866||12,903|
|Loss from operations||(7,547)||(3,419)||(27,094)||(12,903)|
|Other income (expense):|
|Other (expense) income, net||-||3||(442)||14|
|Total other expense, net||(407)||(86)||(1,554)||(414)|
|Net loss and comprehensive loss||(7,954)||(3,505)||(28,648)||(13,317)|
|Accretion of redeemable convertible preferred stock to redemption value||
|Net loss attributable to common stockholders||$||(7,954)||$||(3,510)||$||(28,659)||$||(13,344)|
|Net loss per share attributable to common stockholders per share, basic and diluted||
|Weighted average shares outstanding, basic and diluted||21,289,378||2,659,726||10,652,865||2,609,020|
|OCULAR THERAPEUTIX, INC.|
|(In thousands, except share and per share data)|
|Cash and cash equivalents||$||37,393||$||17,505|
|Accounts receivable from related party||
|Prepaid expenses and other current assets||893||240|
|Total current assets||76,183||18,014|
|Property and equipment, net||1,782||904|
|Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)|
|Notes payable, net of discount, current||1,354||1,806|
|Total current liabilities||5,874||3,342|
|Preferred stock warrants||
Deferred rent, long-term
Notes payable, net of discount, long-term
|Commitments and contingencies|
Redeemable convertible preferred stock (Series A, B, C, D and D-1), $0.001 par value; no shares and 33,979,025 shares authorized at December 31, 2014 and 2013, respectively; no shares and 32,842,187 shares issued and outstanding at December 31, 2014 and 2013, respectively
|Stockholders’ equity (deficit):|
|Preferred stock, $0.0001 par value; 5,000,000 and no shares authorized at December 31, 2014 and 2013, respectively; no shares issued or outstanding at December 31, 2014 and 2013||
|Common stock, $0.0001 par value; 100,000,000 and 45,000,000 shares authorized at December 31, 2014 and 2013, respectively; 21,333,507 and 2,676,648 shares issued and outstanding at December 31, 2014 and 2013, respectively||2||
Additional paid-in capital
|Total stockholders’ equity (deficit)||58,696||(59,472||)|
|Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)||$||78,193||$||19,146|
Ocular Therapeutix, Inc.
Chief Financial Officer
Burns McClellan on behalf of Ocular Therapeutix
Kimberly Minarovich, 212-213-0006
Vice President of Sales and Marketing