Ocular Therapeutix™ Announces Plans to Proceed with an NDA Submission for OTX-DP for Treatment of Post-Surgical Ocular Pain Indication; Reports First Quarter 2015 Financial Results
Company Provides Updates on Anticipated Clinical Milestones and Development Plans
Conference Call Today at
“We are pleased with the overall progress of our pipeline of sustained
release drug delivery products in clinical and preclinical development.
We continue to advance our clinical programs for the treatment of
post-surgical ocular inflammation and pain, allergic conjunctivitis,
inflammatory dry eye disease and glaucoma, with several anticipated
milestones in the near-term. Furthermore, last week we presented
preclinical data on our sustained release hydrogel depot for the
delivery of anti-vascular endothelial growth factors (anti-VEGF) for the
treatment of wet age-related macular degeneration at the recent annual
ARVO meeting in
Dr. Sawhney further commented, “We remain confident about our program for post-surgical ocular inflammation and pain, and our plans for the regulatory and clinical pathway for this product candidate. We intend to submit an NDA for a post-surgical ocular pain indication and conduct an additional Phase 3 clinical trial. Our goal is to subsequently submit an NDA supplement to expand the labeling for the inflammation indication, subject to favorable results from the additional trial and the initial approval of the NDA for the pain indication.”
Clinical Update for DEXTENZA for the Treatment of Post-Surgical Ocular Inflammation and Pain
Following a Pre-NDA Clinical meeting held with
- Submission of an NDA for DEXTENZA for a post-surgical ocular pain indication in the second half of 2015.
- Initiation of an additional Phase 3 clinical trial for DEXTENZA for post-operative ocular inflammation and pain with modifications to the trial design based on learnings from the previously completed second Phase 3 trial, including the exclusion of patients on high-dose nonsteroidal anti-inflammatory drugs (NSAIDs), randomizing patients in a 1:1 ratio into treatment and placebo groups and providing more protocol specificity regarding the administration of rescue medications.
- Submission of an NDA supplement for DEXTENZA to broaden the indication to include treatment of post-operative ocular inflammation, subject to favorable results from the additional Phase 3 clinical trial and the approval of the NDA for DEXTENZA for the pain indication.
Recent Highlights for Other Key Development Programs
Sustained release depots for treatment of retinal diseases
At the recent
The data presented on back-of-the-eye depots focused on demonstrating the viability of the platform for treating retinal diseases using bevacizumab and other anti-VEGF agents as model proteins. In preclinical studies, data showed in-situ formed bioresorbable anti-VEGF hydrogel depots maintain their structure and bioactivity within the company’s hydrogel. Data further showed tolerability and drug release of clinically meaningful concentration and duration.
Decreasing the frequency of intravitreal injections with a sustained release modality remains a major clinical challenge in treating chronic diseases such as age-related macular degeneration (AMD) and diabetic macular edema (DME).
A multi-pronged strategy is being pursued to seek to maximize the potential of this technology for back-of-the-eye diseases. The Company is pursuing ongoing collaborations with several different pharmaceutical companies using protein based anti-VEGF agents and internal development efforts using bevacizumab. Additionally, the delivery of small molecule drugs, such as tyrosine-kinase inhibitors, or TKIs, in the Company’s hydrogel depot are being evaluated. The Company believes this class of drugs is well suited to the Company’s hydrogel depot platform given its high potency, multiple targeting capability, and low water solubility. The Company plans to continue evaluating these multiple pathways as additional preclinical milestones are achieved.
OTX-TP product candidate for the treatment of glaucoma
The Company’s OTX-TP product candidate for the treatment of glaucoma
and ocular hypertension is now in a Phase 2b clinical trial at
multiple sites in
the United States, which is more than 80% enrolled and remains on track to report topline efficacy data in the fourth quarter of 2015.
DEXTENZA product candidate for the treatment of allergic conjunctivitis and inflammatory dry eye disease
- The DEXTENZA product candidate is being investigated for the treatment of allergic conjunctivitis, for which two Phase 3 trials are to be conducted beginning in the middle of 2015.
- DEXTENZA is also being investigated for the treatment of inflammatory dry eye disease and is currently nearing enrollment completion in an exploratory Phase 2 clinical trial, with topline efficacy data to be released in the fourth quarter of 2015.
First Quarter 2015 Financial Results
Ocular Therapeutixreported a net loss of approximately $7.6 million, or $(0.35)per share, for the quarter ended March 31, 2015, compared to a net loss of $7.0 million, or $(2.45)per share, for the quarter ended March 31, 2014. The first quarter 2015 results include $0.9 millionin non-cash charges for stock-based compensation compared to $2.9 millionin non-cash charges for stock-based compensation and licensing and consultant fees paid in common stock in the first quarter of 2014.
Total operating expenses for the quarter ended
March 31, 2015were $7.5 millionas compared to $6.9 millionfor the quarter ended March 31, 2014. Research and development (R&D) expenses for the quarter ended March 31, 2015were $4.7 million, compared to $4.9 millionfor the quarter ended March 31, 2014. In the quarter ended March 31, 2014, there was $1.7 millionin non-cash licensing fees paid in common stock relating to the Company’s intellectual property rights. This was partially offset by increases in personnel costs and clinical trials of DEXTENZA and OTX-TP product candidates.
Ocular Therapeutixgenerated $0.4 millionin revenue during the three months ended March 31, 2015from product sales of ReSure® Sealant and from collaborations with corporate partners.
March 31, 2015, cash and cash equivalents and marketable securities totaled $67.4 million. Cash used in operating activities was $6.9 millionfor the three months ended March 31, 2015.
$15.0 millionin outstanding debt as of March 31, 2015, with an interest only period through September 30, 2015.
May 3, 2015, there were approximately 21.4 million shares issued and outstanding.
Conference Call & Webcast Information
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The live webcast can be accessed by visiting the investor section of the
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number for the live call will be 34331440. An archive of the webcast
will be available until
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, initiation and conduct
of a third clinical trial of OTX-DP for post-surgical inflammation and
pain, the ongoing development of the Company’s sustained release hydrogel
depot technology, 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 clinical trial of
OTX-DP for the treatment of inflammatory dry eye disease, the
advancement of the Company's other 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 Annual Report on Form 10-K
for the year ended
OCULAR THERAPEUTIX, INC.
STATEMENTS OF OPERATIONS
Three Months ended
|Cost of product revenue||56||9|
|Research and development||4,719||4,958|
|Selling and marketing||870||310|
|General and administrative||1,894||1,575|
|Total operating expenses||7,539||6,852|
|Loss from operations||(7,113)||(6,825)|
|Other income (expense):|
|Other (expense) income, net||-||(141)|
|Total other expense, net||(465)||(183)|
|Net loss and comprehensive loss||(7,578)||(7,008)|
|Accretion of redeemable convertible preferred stock to redemption value||
|Net loss attributable to common stockholders||$||(7,578)||$||(7,014)|
|Net loss per share attributable to common stockholders per share, basic and diluted||
|Weighted average shares outstanding, basic and diluted||21,362,731||2,859,752|
OCULAR THERAPEUTIX, INC.
|Cash and cash equivalents||$||12,523||$||37,393|
|Prepaid expenses and other current assets||1,537||893|
|Total current assets||69,470||76,183|
|Property and equipment, net||1,799||1,782|
|Liabilities and Stockholders’ Equity|
|Notes payable, net of discount, current||2,860||1,354|
|Total current liabilities||7,227||5,874|
|Deferred rent, long-term||103||112|
|Notes payable, net of discount, long-term||12,094||13,511|
|Commitments and contingencies|
|Preferred stock, $0.0001 par value; 5,000,000 authorized at March 31, 2015 and December 31, 2014; no shares issued or outstanding at March 31, 2015 and December 31, 2014||—||—|
|Common stock, $0.0001 par value; 100,000,000 shares authorized at March 31, 2015 and December 31, 2014; 21,428,571 and 21,333,507 shares issued and outstanding at March 31, 2015 and December 31, 2014, respectively||2||2|
|Additional paid-in capital||149,077||148,122|
|Total stockholders’ equity||52,073||58,696|
|Total liabilities and stockholders’ equity||$||71,497||$||78,193|
Ocular Therapeutix, Inc.
Chief Financial Officer
Burns McClellan on behalf of Ocular Therapeutix
Kimberly Minarovich, 212-213-0006
Ocular Therapeutix, Inc.
Vice President of Sales and Marketing