LOS ANGELES, CA--(Marketwired - Aug 8, 2016) - Ritter Pharmaceuticals, Inc. (
Quarter Highlights
- RP-G28 received method of use patent which covers methods for treating symptoms associated with lactose intolerance and for overall improvement in gastrointestinal health expiring in 2030
- Enrollment of Phase 2b/3 clinical trial continues to progress very well, keeping the company within its stated timeframe of top-line data in early 2017
"We are pleased with the execution of our Phase 2b/3 trial of RP-G28 in patients suffering from lactose intolerance. Enrollment in this 372 patient study has progressed well, demonstrating strong operational effort by our team and CRO. Interest by patients to enroll in the trial continues to show a clear need for a safe, effective, and durable treatment for lactose intolerance," said Michael D. Step, Chief Executive Officer of Ritter Pharmaceuticals. "While our trial is ongoing, we continue our efforts to position the company for long-term value. As previously announced, we were awarded a method of use patent during the quarter. In total, we are now protected with 9 patents, providing protection for RP-G28 through 2030. Additionally we continue to evaluate RP-G28 for additional medical uses and evaluate preclinical and clinical programs which could offer insight to RP-G28 use in adapting the microbiome. Lastly, we continue to operate the company in a financially sound fashion with the ability to fund the company through our clinical trial results."
Andrew Ritter, President of Ritter Pharmaceuticals, added, "While there is still work to be done, we are confident in our ability to complete this trial and report data by early 2017. This trial consists of a 30-day course of treatment, followed by a 30-day post-treatment evaluation, and therefore can be run in a relatively short period of time. We are excited to be moving toward data in this study and look forward to providing results once available."
Second Quarter 2016 Financial Results
For the second quarter of 2016, Ritter Pharmaceuticals reported a net loss attributable to common stockholders of approximately $4.1 million compared to a net loss of approximately $2.3 million for the second quarter of 2015. Basic and diluted net loss per share was $0.48 for the three months ended June 30, 2016 compared to basic and diluted net loss per share of $4.18 for the same period in 2015.
Research and development expenses totaled approximately $2.9 million for the quarter ended June 30, 2016 versus approximately $48,000 for comparable period of 2015. This increase was primarily attributable to the execution of our Phase2b/3 clinical trial.
General and administrative expenses for the second quarter of 2016 were approximately $1.2 million, compared to approximately $2.0 million for the second quarter of 2015. This decrease was primarily due to non-recurring expenses related to our IPO in Q2 2015, stock-based compensation expense associated with the IPO, offset partially by higher employment expense associated with the clinical trial efforts.
Total operating expenses for the second quarter of 2016 were approximately $4.2 million, compared to approximately $2.1 for the previous year period.
As of June 30, 2016, Ritter Pharmaceuticals had cash and cash equivalents of approximately $10.8 million.
About Ritter Pharmaceuticals
Ritter Pharmaceuticals, Inc. develops novel therapeutic products that modulate the human gut microbiome to treat gastrointestinal diseases. The Company is advancing human gut health research by exploring the metabolic capacity of gut microbiota, and translating the functionality of these microbiome modulators into safe and effective applications. Their lead drug candidate, RP-G28, has the potential to become the first FDA-approved drug for lactose intolerance, a condition that affects more than one billion people worldwide.
Forward-Looking Statements
This release may contain forward-looking statements, which express the current beliefs and expectations of Ritter Pharmaceuticals' management. 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. Any statements contained herein that do not describe historical facts are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. 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, whether as a result of new information, future events or otherwise.
| RITTER PHARMACEUTICALS, INC. | ||||||||||||||||||
| CONDENSED STATEMENTS OF OPERATIONS | ||||||||||||||||||
| (Unaudited) | ||||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||||
| Operating costs and expenses: | ||||||||||||||||||
| Research and development | $ | 2,880,574 | $ | 47,977 | $ | 4,763,422 | $ | 79,555 | ||||||||||
| Patent costs | 68,616 | 50,148 | 100,980 | 112,423 | ||||||||||||||
| General and administrative | 1,206,943 | 2,001,706 | 2,441,961 | 3,304,152 | ||||||||||||||
| Total operating costs and expenses | 4,156,133 | 2,099,831 | 7,306,363 | 3,496,130 | ||||||||||||||
| Operating loss | (4,156,133 | ) | (2,099,831 | ) | (7,306,363 | ) | (3,496,130 | ) | ||||||||||
| Other income: | ||||||||||||||||||
| Interest income | 16,661 | 2,101 | 37,227 | 4,305 | ||||||||||||||
| Other income | -- | -- | 1,214 | 7,091 | ||||||||||||||
| Total other income | 16,661 | 2,101 | 38,441 | 11,396 | ||||||||||||||
| Net loss | $ | (4,139,472 | ) | $ | (2,097,730 | ) | $ | (7,267,922 | ) | $ | (3,484,734 | ) | ||||||
| Cumulative preferred stock dividends | -- | (178,286 | ) | -- | (327,569 | ) | ||||||||||||
| Accretion of discount on Series C preferred stock | -- | (31,465 | ) | -- | (63,283 | ) | ||||||||||||
| Net loss applicable to common shareholders | $ | (4,139,472 | ) | $ | (2,307,481 | ) | $ | (7,267,922 | ) | $ | (3,875,586 | ) | ||||||
| Net loss per common share -- basic and diluted | $ | (0.48 | ) | $ | (4.18 | ) | $ | (0.85 | ) | $ | (7.62 | ) | ||||||
| Weighted-average common shares outstanding -- basic and diluted | 8,584,661 | 551,912 | 8,583,259 | 508,645 | ||||||||||||||
| RITTER PHARMACEUTICALS, INC. | ||||||||||
| CONDENSED BALANCE SHEETS | ||||||||||
| June 30, 2016 | December 31, 2015 | |||||||||
| (unaudited) | ||||||||||
| ASSETS | ||||||||||
| Current assets | ||||||||||
| Cash and cash equivalents | $ | 10,771,639 | $ | 15,819,566 | ||||||
| Prepaid expenses | 65,905 | 189,136 | ||||||||
| Total current assets | 10,837,544 | 16,008,702 | ||||||||
| Other assets | 10,326 | 10,326 | ||||||||
| Property and equipment, net | 26,172 | 20,688 | ||||||||
| Total Assets | $ | 10,874,042 | $ | 16,039,716 | ||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||
| Current liabilities | ||||||||||
| Accounts payable | $ | 1,802,655 | $ | 739,357 | ||||||
| Accrued expenses | 932,028 | 614,141 | ||||||||
| Other liabilities | 12,842 | 1,223 | ||||||||
| Total current liabilities | 2,747,525 | 1,354,721 | ||||||||
| Stockholders' equity | ||||||||||
| Preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of June 30, 2016 and December 31, 2015 | -- | -- | ||||||||
| Common stock, $0.001 par value; 25,000,000 shares authorized; 8,584,661 and 8,582,004 shares issued and outstanding as of June 30, 2016 and December 31, 2015, respectively | 8,585 | 8,582 | ||||||||
| Additional paid-in capital | 42,468,796 | 41,759,355 | ||||||||
| Accumulated deficit | (34,350,864 | ) | (27,082,942 | ) | ||||||
| Total stockholders' equity | 8,126,517 | 14,684,995 | ||||||||
| Total Liabilities and Stockholders' Equity | $ | 10,874,042 | $ | 16,039,716 | ||||||
Contacts Investor Contact: David Burke dburke@theruthgroup.com (646) 536-7009 Media Contact: Chris Hippolyte chippolyte@theruthgroup.com 646.536.7023
