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| 8-K - Qualigen Therapeutics, Inc. | form8-k.htm |
Exhibit 99.1
Ritter Pharmaceuticals Reports Financial Results for the Three and Six Months Ended June 30, 2018 and Recent Progress
LOS ANGELES (August 14, 2018) – Ritter Pharmaceuticals, Inc. (Nasdaq: RTTR) (“Ritter Pharmaceuticals” or the “Company”), a developer of novel therapeutic products that modulate the gut microbiome to treat gastrointestinal diseases with an initial focus on the development of RP-G28, a drug candidate with the potential to be the first FDA-approved treatment for lactose intolerance, today reports financial results for the three and six months ended June 30, 2018.
Recent Corporate Highlights
| ● | Initiated first pivotal Phase 3 trial (“Liberatus”) of RP-G28 for the treatment of lactose intolerance |
| ● | Presented Phase 2b clinical trial data on RP-G28 at Digestive Diseases Week 2018 |
| ● | Andrew J. Ritter named chief executive officer |
| ● | John W. Beck appointed as chief financial officer |
“In the second quarter, we accomplished several key milestones including, most importantly, commencement of our first Phase 3 pivotal clinical trial for RP-G28 in the treatment of lactose intolerance,” said Andrew J. Ritter, chief executive officer of Ritter Pharmaceuticals. “With encouraging results from our Phase 2b trial for RP-G28, we retained many key protocol design components from our prior trials, and developed enhanced controls based on lessons learned from those trials and incorporated guidance and recommendations from our End-of-Phase 2 meeting with the FDA to enhance the design of our Phase 3 program. As a result, we are optimistic about the prospects for our Phase 3 clinical trial and the potential for RP-G28 to become the first FDA-approved treatment for lactose intolerance. Meanwhile, we continue to focus on the clinical and regulatory advancement of RP-G28 and its eventual commercialization, including our development of a more robust strategic commercialization plan and pricing and reimbursement analysis. In addition, we have begun to explore additional indications for RP-G28 in order to expand and enhance our product pipeline.”
Corporate Priorities for Second Half of 2018 include:
| ● | Continue to enroll Liberatus study participants and closely monitor the clinical sites in our Phase 3 clinical trial of RP-G28 | |
| ● | Conduct a panel discussion with leading GI experts Bill Sandborn, M.D. & Bill Chey, M.D. to cover emerging trends in Gastroenterology and the need for new LI treatments | |
| ● | Present additional Phase 2b microbiome data at the American College of Gastroenterology Conference 2018 | |
| ● | Explore additional indications for RP-G28 |
Financial Results
The Company’s net loss for the three and six months ended June 30, 2018 was $3.6 million and $5.6 million, or $0.71 per share and $1.12 per share, respectively, compared to $2.0 million and $3.6 million, or $1.41 per share and $2.84 per share, for the same periods in 2017, respectively. Net loss for the three and six months ended June 30, 2018, included non-cash, stock-based compensation expense of $178,000 and $391,000, respectively, compared to $249,000 and $543,000, for the same periods in 2017, respectively. As of June 30, 2018, the Company had cash and cash equivalents of approximately $16.3 million.
About Ritter Pharmaceuticals
Ritter Pharmaceuticals, Inc. (www.RitterPharma.com, @RitterPharma) develops novel therapeutic products that modulate the gut microbiome to treat gastrointestinal diseases. The Company’s lead product candidate, RP-G28, has the potential to become the first FDA-approved treatment for lactose intolerance, a condition that affects millions of people worldwide. RP-G28 is currently in Phase 3 clinical development. The Company is further exploring the therapeutic potential that gut microbiome changes may have on treating/preventing a variety of diseases including: gastrointestinal diseases, cancer, metabolic, and liver disease.
Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that express the current beliefs and expectations of Ritter Pharmaceuticals’ management, including statements regarding its Phase 3 pivotal clinical trial for RP-G28 in the treatment of lactose intolerance and other research and development initiatives of the Company. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. Factors that could affect our actual results are included in the Company’s most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings that we make with the Securities and Exchange Commission. These forward-looking statements are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise.
Contacts
John
Beck
310-203-1000
John@ritterpharma.com
RITTER PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
| For
the Three Months Ended June 30, | For
the Six Months Ended June 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Operating costs and expenses: | ||||||||||||||||
| Research and development | $ | 1,871,242 | $ | 774,476 | $ | 2,720,925 | $ | 1,206,630 | ||||||||
| Patent costs | 48,263 | 50,661 | 111,351 | 128,363 | ||||||||||||
| General and administrative | 1,686,903 | 1,144,220 | 2,812,794 | 2,315,545 | ||||||||||||
| Total operating costs and expenses | 3,606,408 | 1,969,357 | 5,645,070 | 3,650,538 | ||||||||||||
| Operating loss | (3,606,408 | ) | (1,969,357 | ) | (5,645,070 | ) | (3,650,538 | ) | ||||||||
| Other income: | ||||||||||||||||
| Interest income | 21,756 | 6,333 | 47,728 | 14,279 | ||||||||||||
| Total other income | 21,756 | 6,333 | 47,728 | 14,279 | ||||||||||||
| Net loss | $ | (3,584,652 | ) | $ | (1,963,024 | ) | $ | (5,597,342 | ) | $ | (3,636,259 | ) | ||||
| Net loss per common share – basic and diluted | $ | (0.71 | ) | $ | (1.41 | ) | $ | (1.12 | ) | $ | (2.84 | ) | ||||
| Weighted average common shares outstanding – basic and diluted | 5,064,805 | 1,395,330 | 5,005,116 | 1,278,625 | ||||||||||||
RITTER PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
| June 30, 2018 | December 31, 2017 | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 16,254,455 | $ | 22,631,971 | ||||
| Prepaid expenses | 538,537 | 167,400 | ||||||
| Total current assets | 16,792,992 | 22,799,371 | ||||||
| Other assets | 10,326 | 10,326 | ||||||
| Property and equipment, net | 23,087 | 23,873 | ||||||
| Total Assets | $ | 16,826,405 | $ | 22,833,570 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 1,361,268 | $ | 2,237,579 | ||||
| Accrued expenses | 534,222 | 454,252 | ||||||
| Other liabilities | 14,850 | 15,757 | ||||||
| Total current liabilities | 1,910,340 | 2,707,588 | ||||||
| Stockholders’ equity | ||||||||
| Preferred stock, $0.001 par value; 15,000,000 shares authorized, 7,560 and 9,140 shares issued and outstanding as of June 30, 2018 and December 31, 2017, respectively | 4,241,983 | 5,128,536 | ||||||
| Common stock, $0.001 par value; 225,000,000 shares authorized, 5,334,639 and 4,940,652 shares issued and outstanding as of as of June 30, 2018 and December 31, 2017, respectively | 5,335 | 4,941 | ||||||
| Additional paid-in capital | 69,597,523 | 68,323,939 | ||||||
| Accumulated deficit | (58,928,776 | ) | (53,331,434 | ) | ||||
| Total stockholders’ equity | 14,916,065 | 20,125,982 | ||||||
| Total Liabilities and Stockholders’ Equity | $ | 16,826,405 | $ | 22,833,570 | ||||