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
July 2017, Ocular Therapeutixreceived a Complete Response Letter (CRL) from the U.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.
The CRL from the
FDAreferred to deficiencies in manufacturing processes and analytical testing related to manufacture of drug product for commercial production identified in an outstanding Form FDA-483. The Form FDA-483 was received following an FDApre-NDA approval re-inspection of the Ocular Therapeutixmanufacturing facility that was completed in May 2017. Ocular Therapeutixplans to produce additional commercial batches of DEXTENZA and submit data from these batches to the FDAwith the resubmission of its NDA.
OTX-TP (travoprost insert) for the treatment of glaucoma and ocular hypertension
Ocular Therapeutixcontinues 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, and 4pm, 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.
- 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
Ocular Therapeutixis 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
Ocular Therapeutixis 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 Therapeutixpresented 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.
- At the ARVO Annual Meeting in
In partnership with
Regeneron Pharmaceuticals, Ocular Therapeutixalso 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
June 30, 2017, cash, cash equivalents and marketable securities totaled $66.0 million. Cash used in operating activities was $11.3 millionin the second quarter of 2017, compared to $9.8 millionfor 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 Therapeutixreported a net loss of approximately $(18.7) million, or $(0.64)per share, for the quarter ended June 30, 2017, compared to a net loss of $(11.4) million, or $(0.46)per share, for the quarter ended June 30, 2016. The second quarter 2017 results include $2.1 millionin non-cash charges for stock-based compensation and depreciation compared to $1.7 millionin such non-cash charges in the second quarter of 2016.
Total costs and operating expenses for the quarter ended
June 30, 2017were $18.8 million, as compared to $11.5 millionfor the quarter ended June 30, 2016. Research and development expenses for the quarter ended June 30, 2017were $8.1 million, compared to $7.0 millionfor the quarter ended June 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 Therapeutixgenerated $0.4 millionin revenue during the three-month period ended June 30, 2017from product sales of ReSure® Sealant.
June 30, 2017, there were approximately 29.1 million shares issued and outstanding.
Conference Call & Webcast Information
Members of the
The live webcast can be accessed by visiting the Investors section of
the Company’s website at investors.ocutx.com. Please connect at least 15
minutes prior to the live webcast to ensure adequate time for any
software download that may be needed to access the webcast.
Alternatively, please call 844-464-3934 (U.S.) or 765-507-2620
(International) to listen to the live conference call. The conference ID
number for the live call will be 59980638. An archive of the webcast
will be available until
About Ocular Therapeutix, Inc.
Forward Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company including the development and regulatory status of the Company’s product candidates, such as the Company’s expectations and plans regarding product development efforts and regulatory submissions for and the timing and conduct of clinical trials of DEXTENZA for the treatment of post-surgical ocular inflammation and pain, including with respect to the manufacturing deficiencies identified by the
Ocular Therapeutix, Inc.
Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Costs and operating expenses:|
|Cost of product revenue||104||105||219||204|
|Research and development||8,117||6,978||14,846||14,051|
|Selling and marketing||6,832||1,492||12,859||2,881|
|General and administrative||3,724||2,973||7,000||5,379|
|Total costs and operating expenses||18,777||11,548||34,924||22,515|
|Loss from operations||(18,339||)||(11,107||)||(34,011||)||(21,616||)|
|Other income (expense):|
|Total other expense, net||(355||)||(338||)||(706||)||(669||)|
|Net loss per share, basic and diluted||$||(0.64||)||$||(0.46||)||$||(1.22||)||$||(0.90||)|
|Weighted average common shares outstanding, basic and diluted||29,026,259||24,770,059||28,352,348||24,761,498|
|Other comprehensive income (loss):|
|Unrealized gain on marketable securities||9||10||5||78|
|Total other comprehensive income||9||10||5||78|
|Total comprehensive loss||$||(18,685||)||$||(11,435||)||$||(34,712||)||$||(22,207||)|
(In thousands, except share and per share data)
|June 30,||December 31,|
|Cash and cash equivalents||$||63,049||$||32,936|
|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|
|Liabilities and Stockholders’ Equity|
|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|
|Commitments and contingencies (Note 11)|
|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, $0.0001 par value; 100,000,000 shares authorized at June 30, 2017 and December 31, 2016; 29,055,460 and 25,024,100 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively||3||3|
|Additional paid-in capital||256,618||225,889|
|Accumulated other comprehensive loss||—||(5||)|
|Total stockholders’ equity||48,025||52,008|
|Total liabilities and stockholders’ equity||$||79,675||$||74,939|
Steve Klass, 212-213-0006
Interim Chief Financial Officer
Vice President of Marketing & Commercial Operations