LOS ANGELES, CA--(Marketwired - Aug 7, 2017) - Ritter Pharmaceuticals, Inc. (
Recent Highlights
- Announced that the FDA has agreed to schedule an end-of-Phase 2 meeting with the Company that is expected to occur in the third quarter of 2017;
- Announced the issuance of three new patents, two in the U.S. and one in Australia, directed toward compositions containing and methods of using RP-G28;
- Entered into a common stock purchase agreement with Aspire Capital Fund to access up to $6.5 million through the sale of company stock;
- Reported additional analyses from the Company's Phase 2b/3 trial demonstrating significant reductions in lactose intolerance.
"Our activities at the Company have been very much focused on moving RP-G28 into Phase 3 clinical development," said Michael D. Step, Chief Executive Officer of Ritter Pharmaceuticals. "To that end, we have requested and have scheduled an End-of-Phase 2 meeting with the FDA to discuss the Phase 2b/3 clinical trial data and requirements for Phase 3 studies and NDA submission. We have also conducted further analysis of the results of our Phase 2b/3 clinical trial. Based on our analysis, we believe that the data supports RP-G28's potentially significant and durable real-world treatment effect for patients suffering from lactose intolerance. We look forward to our meeting with the FDA and moving RP-G28 toward regulatory approval."
Second Quarter 2017 Financial Results
For the second quarter of 2017, Ritter Pharmaceuticals reported a net loss attributable to common stockholders of approximately $2.0 million compared to a net loss of approximately $4.1 million for the second quarter of 2016. Basic and diluted net loss per share was $0.14 for the three months ended June 30, 2017 compared to basic and diluted net loss per share of $0.48 for the same period in 2016.
Research and development expenses for the second quarter of 2017 totaled approximately $774,000 compared to approximately $2.9 million for the second quarter of 2016. This decrease was due to the completion of the Phase 2b/3 clinical trial in the fourth quarter of 2016, with research and development expenses in the second quarter of 2017 mainly reflecting extension study fees and Phase 2b/3 analysis costs.
General and administrative expenses for the second quarter of 2017 were fairly consistent with the second quarter of 2016 at approximately $1.1 million and $1.2 million, respectively.
As of June 30, 2017, Ritter Pharmaceuticals had cash of approximately $5.4 million.
About Ritter Pharmaceuticals Ritter Pharmaceuticals, Inc. ( www.RitterPharma.com , @RitterPharma) develops novel therapeutic products that modulate the gut microbiome to treat gastrointestinal diseases. Its lead product, RP-G28, has the potential to become the first FDA-approved treatment for lactose intolerance, a condition that affects millions worldwide. The company is further exploring the functionality and discovering the therapeutic potential gut microbiome changes may have on treating/preventing a variety of conditions including: gastrointestinal diseases, immuno-oncology, metabolic, and liver disease.
Forward-Looking Statements This release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to our ability to bring RP-G28 to market. Management believes that these forward-looking statements are reasonable as and when made. However, such statements involve a number of known and unknown risks and uncertainties that could cause the Company's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the drug development process generally, including the outcomes of planned clinical trials and the regulatory review process. For a discussion of certain risks and uncertainties affecting Ritter Pharmaceuticals' forward-looking statements, please review the Company's reports filed with the Securities and Exchange Commission, including, but not limited to, its Annual Report on Form 10-K for the year ended December 31, 2016 and Quarterly Reports on Form 10-Q for the periods ended March 31, 2017 and June 30, 2017. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. These statements are based on management's current expectations and Ritter Pharmaceuticals does not undertake any responsibility to revise or update any forward-looking statements contained herein, except as expressly required by law.
| RITTER PHARMACEUTICALS, INC. | |||||||||||||||||
| CONDENSED STATEMENTS OF OPERATIONS | |||||||||||||||||
| (Unaudited) | |||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||
| 2017 | 2016 | 2017 | 2016 | ||||||||||||||
| Operating costs and expenses: | |||||||||||||||||
| Research and development | $ | 774,476 | $ | 2,880,574 | $ | 1,206,630 | $ | 4,763,422 | |||||||||
| Patent costs | 50,661 | 68,616 | 128,363 | 100,980 | |||||||||||||
| General and administrative | 1,144,220 | 1,206,943 | 2,315,545 | 2,441,961 | |||||||||||||
| Total operating costs and expenses | 1,969,357 | 4,156,133 | 3,650,538 | 7,306,363 | |||||||||||||
| Operating loss | (1,969,357 | ) | (4,156,133 | ) | (3,650,538 | ) | (7,306,363 | ) | |||||||||
| Other income: | |||||||||||||||||
| Interest income | 6,333 | 16,661 | 14,279 | 37,227 | |||||||||||||
| Other income | -- | -- | -- | 1,214 | |||||||||||||
| Total other income | 6,333 | 16,661 | 14,279 | 38,441 | |||||||||||||
| Net loss | $ | (1,963,024 | ) | $ | (4,139,472 | ) | $ | (3,636,259 | ) | $ | (7,267,922 | ) | |||||
| Net loss per common share ― basic and diluted | $ | (0.14 | ) | $ | (0.48 | ) | $ | (0.28 | ) | $ | (0.85 | ) | |||||
| Weighted-average common shares outstanding -- basic and diluted | 13,953,302 | 8,584,661 | 12,786,249 | 8,583,259 | |||||||||||||
| RITTER PHARMACEUTICALS, INC. | |||||||||
| CONDENSED BALANCE SHEETS | |||||||||
| June 30, 2017 | December 31, 2016 | ||||||||
| (unaudited) | |||||||||
| ASSETS | |||||||||
| Current assets | |||||||||
| Cash and cash equivalents | $ | 5,415,298 | $ | 7,046,282 | |||||
| Prepaid expenses | 346,403 | 156,752 | |||||||
| Total current assets | 5,761,701 | 7,203,034 | |||||||
| Other assets | 10,326 | 10,326 | |||||||
| Property and equipment, net | 20,921 | 23,542 | |||||||
| Total Assets | $ | 5,792,948 | $ | 7,236,902 | |||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||
| Current liabilities | |||||||||
| Accounts payable | $ | 2,091,932 | $ | 1,896,368 | |||||
| Accrued expenses | 675,521 | 1,222,735 | |||||||
| Other liabilities | 15,530 | 14,736 | |||||||
| Total current liabilities | 2,782,983 | 3,133,839 | |||||||
| Stockholders' equity | |||||||||
| Preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of June 30, 2017, and December 31, 2016 | -- | -- | |||||||
| Common stock, $0.001 par value; 25,000,000 shares authorized; 14,756,521 and 11,619,197 shares issued and outstanding as of June 30, 2017, and December 31, 2016, respectively | 14,757 | 11,619 | |||||||
| Additional paid-in capital | 52,099,043 | 49,559,020 | |||||||
| Accumulated deficit | (49,103,835 | ) | (45,467,576 | ) | |||||
| Total stockholders' equity | 3,009,965 | 4,103,063 | |||||||
| Total Liabilities and Stockholders' Equity | $ | 5,792,948 | $ | 7,236,902 | |||||
Contacts Ellen Mochizuki 310-203-1000 ellen@ritterpharma.com
