HOUSTON, Nov. 09, 2017 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (NASDAQ:PLXP) (“PLx” or the “Company”), a late-stage specialty pharmaceutical company focused on commercializing two patent-protected products, Aspertec™ 325 mg and Aspertec™ 81 mg (referred to together as “Aspertec”™), announced today its financial and certain operational results for the three- and nine-month periods ended September 30, 2017.
Highlights of and subsequent to the third quarter of 2017 include:
- Net loss totaled $3.8 million, or ($0.44) per basic and diluted share, compared to net loss of $1.1 million, or ($0.25) per basic and diluted share, for the third quarter of 2016;
- Expect to file a supplemental NDA for our 81 mg dosage with the U.S. Food and Drug Administration (FDA) by the mid first half of 2018. Once the sNDA is approved, the Company plans to launch the 81mg dose together with the already approved 325 mg strength by the end of 2018;
- Retained Dr. Efthymios N. Deliargyris, an internationally-recognized expert in the field of thrombosis, as Chief Medical Advisor to oversee critical scientific and medical affairs activities that are expected to advance the market readiness of Aspertec;
- Appointed Tom Long as Vice President, Manufacturing & Technical Operations, and Steven Valentino as Vice President, Trade Sales; and,
- Entered into a term loan facility with Silicon Valley Bank in August under which the Company initially borrowed $7.5 million, and will have the right to borrow an additional $7.5 million on or before December 31, 2018, under certain terms.
“We continue to make significant progress preparing for the future launch of Aspertec, which when launched is expected to be the only over-the-counter (OTC) aspirin product approved by the FDA as a New Drug Application. We believe Aspertec has the potential to set a new standard of care for Secondary Prevention of Coronary Artery Disease and to become the best-in-class alternative for physicians treating patients at risk of having a cardiovascular or cerebrovascular event,” said Natasha Giordano, President and Chief Executive Officer of PLx Pharma.
“Aspertec and its novel delivery system, which is protected by 44 issued patents, has been clinically proven to have more predictable and reliable antiplatelet efficacy than enteric-coated aspirin, as well as improved GI safety over regular aspirin, in an acute setting. We intend to implement a unique and comprehensive launch campaign targeting both the OTC and prescription markets.”
“We have now put in place a strong management team, Board of Directors, and Scientific Advisory Board. We are excited about making these differentiated aspirin products available to patients at risk at the end of 2018,” concluded Giordano.
Third Quarter 2017 Financial Results
The Company recognized revenue of $62,000 in the third quarter of 2017 from a federal grant received earlier in the year. The Company had no revenue in the third quarter of 2016.
Research and development expenses were approximately $1.0 million for the third quarter of 2017 reflecting, the initiation of technology transfer, contract manufacturing activities, and other product development activities for Aspertec. The Company incurred less than $13,000 of research and development expenses in 2016.
General and administrative expense increased to $3.0 million in the third quarter of 2017 from $1.0 million in the third quarter of 2016, due to increased compensation of $1.4 million, including non-cash stock-based compensation expense, and other professional and administrative fees associated with being a public company of approximately $0.6 million.
Other income/expense increased to $118,000 of income, as compared to $29,000 of expense in 2016. This increase related to the non-cash change in fair value of a warrant liability of $252,000 tempered by $168,000 of interest expense and debt discount amortization related to the Company’s new term loan with Silicon Valley Bank.
Net loss for the third quarter of 2017 was $3.8 million, or ($0.44) per basic and diluted share, compared to a net loss of $1.1 million, or ($0.25) per basic and diluted share, for the third quarter of 2016.
Nine Months Ended September 30, 2017 and 2016 Financial Results
For the nine months ended September 30, 2017, the Company recognized revenue of $438,000, compared to $20,000 in 2016. This increase resulted from the new federal grant received in 2017.
Research and development expenses were $1.7 million in the nine months ended September 30, 2017, reflecting the initiation of technology transfer, contract manufacturing activities, and other product development activities for Aspertec. The Company incurred less than $66,000 of research and development expenses in the same period of 2016.
General and administrative expense increased to $8.3 million for the nine months ended September 30, 2017 from $3.3 million for the first nine months of 2016, reflecting increased compensation of $2.2 million, including non-cash stock-based compensation and a one-time bonus, expenses attributable to the warrant liability associated with the June 2017 equity offering of $1.3 million, and professional and administrative fees associated with being a public company of approximately $1.4 million.
Other income/expense increased to $1.2 million of income as compared to $62,000 of expense in 2016. The increase related to income from the non-cash change in the fair value of a warrant liability of $2.0 million partially offset by $0.9 million of interest expense. Interest expense in 2017 includes $0.7 million of non-cash interest expense upon recognition upon conversion of convertible notes and $0.2 million of interest expense and debt discount amortization related to the Company’s new term loan with Silicon Valley Bank.
Net loss for the nine months ended September 30, 2017 was $7.5 million, or ($1.16) per basic and diluted share, compared with a net loss of $3.5 million, or ($0.79) per basic and diluted share in the prior year period.
As previously announced, PLx management will host its 2017 third quarter conference call as follows:
|Date||Friday, November 10, 2017|
|Time||8:30 a.m. EST|
|Toll free (U.S.)||(866) 394-2901|
|Webcast (live and replay)||www.plxpharma.com under the ‘Investor Relations’ section.|
A replay of the conference call will be available for two weeks after the call's completion by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (International). The conference ID for the replay is 3388277. The archived webcast will be available for 30 days via the aforementioned URL.
Aspertec 325 mg is an FDA-approved aspirin product being developed to provide high-risk cardiovascular and stroke patients with more reliable and predictable antiplatelet efficacy as compared to enteric-coated aspirin, while also reducing the adverse gastric events common in an acute setting. PLx is focused on completing manufacturing scale-up and label finalization for Aspertec 325 mg aspirin dosage form and preparing an sNDA for Aspertec 81 mg maintenance dose form.
About PLx Pharma Inc.
PLx Pharma Inc. is a late-stage specialty pharmaceutical company focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide safe and effective aspirin products. The PLxGuard delivery system works by targeting delivery of active pharmaceutical ingredients (API) to various portions of the gastrointestinal (GI) tract. PLx believes this has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce acute GI side effects—including erosions, ulcers and bleeding—associated with aspirin and ibuprofen, and potentially other drugs.
To learn more about PLx Pharma Inc. and its pipeline, please visit www.plxpharma.com.
Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the prospects for commercializing or selling any products or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to PLx may identify forward-looking statements. PLx cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by PLx to secure and maintain relationships with collaborators; risks relating to clinical trials; risks relating to the commercialization, if any, of PLx’s proposed product candidates (such as marketing, regulatory, product liability, supply, competition, and other risks); dependence on the efforts of third parties; dependence on intellectual property and risks that PLx may lack the financial resources and access to capital to fund proposed operations. Further information on the factors and risks that could affect PLx’s business, financial conditions and results of operations are contained in PLx’s filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Other risks and uncertainties are more fully described in PLx’s prospectus supplement filed with the SEC on June 12, 2017, and in other filings that PLx will make going forward. The forward-looking statements represent PLx’s estimate as of the date hereof only, and PLx specifically disclaims any duty or obligation to update forward-looking statements.
Lisa M. Wilson, In-Site Communications, Inc.
FINANCIAL TABLES FOLLOW
|PLx Pharma Inc.|
|UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||958,255||12,496||1,712,890||65,537|
|General and administrative||3,021,290||1,041,142||8,263,019||3,343,458|
|TOTAL OPERATING EXPENSES||3,979,545||1,053,638||9,975,909||3,408,995|
|OTHER INCOME (EXPENSE)|
|Change in fair value of warrant liability||252,458||-||1,998,878||-|
|TOTAL OTHER INCOME (EXPENSE)||117,786||(28,803||)||1,155,125||(62,466||)|
|LOSS BEFORE INCOME TAX BENEFIT||(3,799,500||)||(1,082,441||)||(8,382,574||)||(3,451,461||)|
|Income tax benefit||-||-||920,000||-|
|Net loss per common share - basic and diluted||$||(0.44||)||$||(0.25||)||$||(1.16||)||$||(0.79||)|
|Weighted average shares of common shares - basic and diluted||8,704,985||4,383,433||6,447,053||4,383,433|
|PLx Pharma Inc.|
|UNAUDITED CONSOLIDATED BALANCE SHEETS|
|September 30, 2017||December 31, 2016|
|Cash and cash equivalents||$||30,438,464||$||59,335|
|Accounts Receivable, net||56,713||5,077|
|Contract manufacturing deposit||247,050||-|
|TOTAL CURRENT ASSETS||31,455,531||189,854|
|Property and equipment, net||902,368||426,634|
|Intangible assets, net||2,296,429||-|
|LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)|
|Accounts payable and accrued liabilities||$||1,045,406||$||862,995|
|Accrued interest - related parties||-||30,344|
|Convertible notes payable||-||1,297,700|
|Convertible notes payable - related parties||-||480,000|
|TOTAL CURRENT LIABILITIES||3,505,969||2,735,820|
|Accrued interest - net of current portion||35,759||-|
|Term loan, net of discount and fees||6,868,143||-|
|STOCKHOLDERS' EQUITY (DEFICIT)|
|Preferred stock; $0.001 par value; 10,000,000 shares authorized; none issued and outstanding||-||-|
|Common stock; $0.001 par value; 100,000,000 shares authorized; 8,719,535 and 4,282,433 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively||||8,720||4,383|
|Additional paid-in capital||71,655,397||49,661,802|
|TOTAL STOCKHOLDERS' EQUITY (DEFICIT)||12,216,026||(2,319,332||)|
|TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)||$||36,771,980||$||616,488|
Source:PLX Pharma Inc.