World News: 13:00 GMT Wednesday 15th May 2019. [Outlook Therapeutics, Inc. via Globe Newswire via SPi World News]
CRANBURY, N.J., May 15, 2019 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK) (the “Company”) today reported business highlights and financial results for its second fiscal quarter ended March 31, 2019.
“We are pleased with the progress being made in both of our Phase 3 clinical trials for ONS-5010 thus far in 2019, which includes the FDA’s acceptance of our IND for ONS-5010 and the initiation of our second Phase 3 trial. The two studies remain on track with our plan to submit ONS-5010 for regulatory approval in multiple markets in 2020,” said Lawrence A. Kenyon, President, Chief Executive Officer and Chief Financial Officer. “The financing we secured in the equity offering announced in April has provided us with the capital needed to complete enrollment in our two Phase 3 clinical trials. This was an important step in our strategy and to maintain the positive momentum behind our clinical development program for ONS-5010.”
ONS-5010-002, the second of the two adequate and well controlled Phase 3 clinical trials evaluating ONS-5010 against ranibizumab (Lucentis®) for wet AMD has been initiated in the United States, Australia and New Zealand and is expected to begin dosing patients in June 2019. In April, the U.S. Food and Drug Administration (FDA) accepted and activated the Company’s investigational new drug (IND) application for ONS-5010. Patients enrolled in the ONS-5010-002 study will be treated for 11 months. The primary outcome of the study is a statistically significant improvement in mean visual acuity of five letters or more for ONS-5010 over ranibizumab.
If the ONS-5010 clinical program is successful, it will support the Company’s plan to submit for regulatory approval in multiple markets in 2020. If approved, ONS-5010 has potential to mitigate risks associated with off-label use of Avastin or other drugs. Off label use of Avastin is currently estimated to account for approximately 50% of all wet AMD prescriptions in the United States.
As the Company has shifted its focus to ONS-5010 over the past year, the requirements asked of the senior leadership team have changed. This has resulted in several new hires and changes at the senior level of the Company. Most recently, the Company appointed Jennifer M. Kissner, Ph.D. as the Senior Vice President of Clinical Development. Dr. Kissner has extensive experience in therapeutic product development from the benchtop through clinical development and regulatory filing, including small molecules, biologics, gene therapy and devices, across multiple therapeutic areas, specifically working in the retina space for 12 years. The Company expects her clinical development expertise, specializing in wet AMD and other retina diseases, to play an important role in the advancement of the ONS-5010 program.
“We continue to attract exceptionally talented people from the wet AMD and retinal disease industry to Outlook Therapeutics. The industry knowledge and experience of those like Dr. Kissner will allow us to efficiently execute on our strategy to advance our streamlined ONS-5010 program through clinical development and, pending the outcome of our trials and regulatory approval, properly implement an effective commercialization strategy,” continued Mr. Kenyon.
For the fiscal quarter ended March 31, 2019, the Company reported an adjusted net loss attributable to common stockholders of $6.7 million, or $0.58 per basic and diluted share, as compared to an adjusted net loss of $6.9 million, or $2.15 per basic and diluted share, in the second quarter of fiscal 2018. Adjusted net loss attributable to common stockholders in the second quarter of fiscal 2019 includes $0.3 million of non-cash stock-based compensation, $0.8 million of depreciation and amortization, $0.4 million of non-cash interest expense, $0.2 million of loss on extinguishment of debt, a $1.3 million increase in the fair value of warrant liability, $0.6 million of loss on disposal of property and equipment, $0.1 million for recognition of the beneficial conversion feature of the Company’s Series A-1 convertible preferred stock, $0.2 million stock dividend for the Company’s Series A-1 convertible preferred stock, and $0.8 million for a deemed dividend upon the modification of outstanding warrants. For the fiscal 2018 second quarter, adjusted net loss attributable to common stockholders included $0.7 million of depreciation and amortization, $0.4 million of non-cash interest expense, $0.4 million for recognition of the beneficial conversion feature for convertible preferred stock, and a $0.6 million stock dividend for the Company’s Series A convertible preferred stock, which was partially offset by $0.2 million of income from a decrease in the fair value of warrant liability and $0.3 million of income from non-cash stock-based compensation.
At March 31, 2019, the Company had cash of $0.2 million, compared to $1.7 million at September 30, 2018. In April, the Company completed a public offering of common stock and warrants for net proceeds of approximately $26.2 million, after payment of fees, expenses and underwriting discounts and commissions. The Company will use the net proceeds from the offering to fund the Phase 3 clinical trials of ONS-5010 for wet AMD, DME and BRVO; and the remainder for general corporate purposes, funding its working capital needs, and scheduled repayments of $5.0 million outstanding principal and accrued interest on its 5% senior secured notes as required by the terms of a November 2018 amendment.
For additional details on the Company’s financial performance during the quarter, please see the Company’s filings with the .
Globe Newswire: 13:00 GMT Wednesday 15th May 2019
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