HOUSTON, Aug. 10, 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 financial results for the three- and six-month periods ended June 30, 2017.
Highlights of and subsequent to the second quarter of 2017 include:
- Total net revenue from a federal grant was $375,951, compared to $20,000 for the second quarter of 2016;
- Net loss totaled $2.2 million, or ($0.36) per basic and diluted share, compared to net loss of $1.5 million, or ($0.33) per basic and diluted share, for the second quarter of 2016;
- Entered into a term loan facility with Silicon Valley Bank 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. Armentum Partners acted as the Company’s financial advisor on the transaction;
- Completed a registered direct offering of 2,646,091 shares of common stock at an offering price per share of $6.875, as well as a concurrent private placement of warrants to purchase up to an equivalent number of shares of common stock with an exercise price of $7.50 per share, resulting in gross proceeds to the Company of approximately $18.2 million;
- Awarded a $1.9 million grant by the National Cancer Institute (NCI) of the National Institutes of Health (NIH) in support of PLx’s novel formulation of aspirin for chemoprevention of colorectal cancer;
- Appointed Rita O’Connor, a seasoned finance executive with an extensive background in finance, strategic partnering, merger and acquisitions and equity fundraising, as Chief Financial Officer, effective July 1, 2017;
- Strengthened management team adding industry veteran and commercial leader, Michael J. Dillon, as Vice President, Sales and Marketing; and,
- Completed its previously announced merger with Dipexium Pharmaceuticals, Inc., effective as of April 19, 2017.
"We continue to build a strong foundation for the future launch of Aspertec, our liquid-filled aspirin capsule. Aspertec 325mg is FDA-approved for over-the-counter (OTC) distribution, and we are presently preparing to file the 81 mg sNDA,” said Natasha Giordano, President and Chief Executive Officer of PLx Pharma. “We believe this highly differentiated product has the potential to benefit millions of patients at risk for cardiovascular disease and in need of fast-acting, safe, reliable and predictable antiplatelet activity.”
“We are pleased to have strengthened our management team and balance sheet, and look forward to making these differentiated aspirin products available to better meet the needs of patients at risk,” concluded Ms. Giordano.
Second Quarter 2017 Financial Results
Net revenue from a federal grant for the second quarter of 2017 was $375,951, compared to $20,000 for the second quarter of 2016.
Research and development expense increased to $626,296 for the second quarter of 2017, compared to $13,081 for the second quarter of 2016, reflecting the initiation of technology transfer, contract manufacturing activities, and product development activities for Aspertec.
General and administrative expense increased to $4.0 million for the second quarter of 2017 from $1.5 million for the second quarter of 2016, due to increased compensation and outside directors’ fees, public offering costs and higher professional fees, partially offset by lower stock compensation expense.
Net loss for the second quarter of 2017 was $2.2 million, or ($0.36) per basic and diluted share, compared to a net loss of $1.5 million, or ($0.33) per basic and diluted share, for the second quarter of 2016.
Six Months Ended June 30, 2017 and 2016 Financial Results
For the six months ended June 30, 2017, net revenue was $375,951, compared to $20,000 in 2016, this increase is due to a federal grant compared to the prior year.
Research and development expense increased to $754,635 for the six months ended June 30, 2017, compared to $53,041 for the first six months of 2016, reflecting the initiation of technology transfer, contract manufacturing activities, and product development activities for Aspertec.
General and administrative expense increased to $5.2 million for the six months ended June 30, 2017 from $2.3 million for the first six months of 2016, reflecting increased compensation and outside directors’ fees, public offering costs and professional fees, partially offset by lower stock compensation expense.
Net loss for the six months ended June 30, 2017 was $3.7 million, or ($0.69) per basic and diluted share, compared with a net loss of $2.4 million, or ($0.54) per basic and diluted share in the prior year period.
About Aspertec
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.
Forward-Looking Statements
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.
| PLx Pharma Inc. | ||||||||||||||||
| UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| REVENUES: | ||||||||||||||||
| Federal grant | $ | 375,951 | $ | - | $ | 375,951 | $ | - | ||||||||
| License revenue | - | 20,000 | - | 20,000 | ||||||||||||
| TOTAL REVENUES | 375,951 | 20,000 | 375,951 | 20,000 | ||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Research and development | 626,296 | 13,081 | 754,635 | 53,041 | ||||||||||||
| General and administrative | 4,024,658 | 1,450,747 | 5,241,729 | 2,302,316 | ||||||||||||
| TOTAL OPERATING EXPENSES | 4,650,954 | 1,463,828 | 5,996,364 | 2,355,357 | ||||||||||||
| OPERATING LOSS | (4,275,003 | ) | (1,443,828 | ) | (5,620,413 | ) | (2,335,357 | ) | ||||||||
| OTHER INCOME (EXPENSE) | ||||||||||||||||
| Interest income | 14,482 | 309 | 14,482 | 378 | ||||||||||||
| Interest expense | (642,006 | ) | (24,608 | ) | (723,563 | ) | (34,041 | ) | ||||||||
| Change in fair value of warrant liability | 1,746,420 | - | 1,746,420 | - | ||||||||||||
| TOTAL OTHER INCOME (EXPENSE) | 1,118,896 | (24,299 | ) | 1,037,339 | (33,663 | ) | ||||||||||
| LOSS BEFORE INCOME TAX BENEFIT | (3,156,107 | ) | (1,468,127 | ) | (4,583,074 | ) | (2,369,020 | ) | ||||||||
| Income tax benefit | 920,000 | - | 920,000 | - | ||||||||||||
| NET LOSS | $ | (2,236,107 | ) | $ | (1,468,127 | ) | $ | (3,663,074 | ) | $ | (2,369,020 | ) | ||||
| Loss per common share - basic and diluted | $ | (0.36 | ) | $ | (0.33 | ) | $ | (0.69 | ) | $ | (0.54 | ) | ||||
| Weighted average shares of common shares - basic and diluted | 6,157,970 | 4,383,433 | 5,275,603 | 4,383,433 | ||||||||||||
| PLx Pharma Inc. | |||||||
| UNAUDITED CONSOLIDATED BALANCE SHEETS | |||||||
| June 30, 2017 | December 31, 2016 | ||||||
| ASSETS | |||||||
| CURRENT ASSETS | |||||||
| Cash and cash equivalents | $ | 25,079,590 | $ | 59,335 | |||
| Accounts receivable, net | 381,028 | 5,077 | |||||
| Inventory, net | 394,740 | 116,726 | |||||
| Contract manufacturing deposit | 657,400 | - | |||||
| Prepaid expenses | 359,293 | 4,652 | |||||
| Security deposit | 4,064 | 4,064 | |||||
| TOTAL CURRENT ASSETS | 26,876,115 | 189,854 | |||||
| NON-CURRENT ASSETS | |||||||
| Property and equipment, net | 513,986 | 426,634 | |||||
| Security deposit - noncurrent | 56,630 | - | |||||
| Intangible assets, net | 2,300,000 | - | |||||
| Goodwill | 2,061,022 | - | |||||
| TOTAL ASSETS | $ | 31,807,753 | $ | 616,488 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | |||||||
| CURRENT LIABILITIES | |||||||
| Accounts payable and accrued liabilities | $ | 476,039 | $ | 862,995 | |||
| Accrued severance | 2,284,000 | - | |||||
| Accrued interest | - | 64,781 | |||||
| Accrued interest - related parties | - | 30,344 | |||||
| Convertible notes payable | - | 1,297,700 | |||||
| Convertible notes payable - related parties | - | 480,000 | |||||
| TOTAL CURRENT LIABILITIES | 2,760,039 | 2,735,820 | |||||
| NON-CURRENT LIABILITIES | |||||||
| Deferred revenue | 200,000 | 200,000 | |||||
| Warrant liability | 14,130,126 | - | |||||
| TOTAL LIABILITIES | 17,090,165 | 2,935,820 | |||||
| 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; 8,686,010 and 4,383,433 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively | 8,686 | 4,383 | |||||
| Additional paid-in capital | 70,357,493 | 49,661,802 | |||||
| Accumulated deficit | (55,648,591 | ) | (51,985,517 | ) | |||
| TOTAL STOCKHOLDERS' EQUITY (DEFICIT) | 14,717,588 | (2,319,332 | ) | ||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | $ | 31,807,753 | $ | 616,488 | |||