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-- Completed Pivotal Enrollment in Two Ongoing Phase 3 Clinical Trials Evaluating Setmelanotide in Pro-opiomelanocortin (POMC) and Leptin Receptor (LEPR) Deficiency Obesity --
-- Announced New Topline Clinical Data from Ongoing Phase 2 Basket Studies Evaluating Setmelanotide in Rare Genetic Disorders of Obesity, Including Updated Data in Bardet-Biedl Syndrome (BBS) and Proof-of-Concept Data in Alström Syndrome --
-- Granted PRIority MEdicines (PRIME) Designation by the European Medicines Agency (EMA) for Setmelanotide --
-- Successfully Completed $174 Million Public Offering --
BOSTON, Aug. 08, 2018 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (NASDAQ:RYTM), a biopharmaceutical company focused on the development and commercialization of therapeutics for the treatment of rare genetic disorders of obesity, today reported financial results and provided a business update for the second quarter ended June 30, 2018.
“Rhythm is entering a transformative period of development, as we continue to execute on our mission of providing new therapies for people living with rare genetic disorders of obesity,” said Keith Gottesdiener, M.D., Chief Executive Officer of Rhythm. “In recent months, we announced major clinical and regulatory advancements across our setmelanotide development program, including the completion of pivotal enrollment in our two ongoing Phase 3 trials in POMC and LEPR deficiency obesity, positive topline results from our ongoing Phase 2 basket studies in several additional rare genetic disorders of obesity, and receipt of PRIME designation from the EMA. Together, these accomplishments support our belief in setmelanotide as a new therapeutic option that has the potential to effectively address the excess hunger and weight associated with rare genetic disorders of obesity, and provide us with a clear and efficient path for further development. Following our successful follow-on offering, we are well capitalized, and believe we have sufficient resources to advance our ongoing clinical and market development efforts into the second half of 2020.”
Second Quarter and Recent Business Highlights:
Pipeline:
Corporate:
Upcoming Milestones:
Second Quarter 2018 Financial Results:
Year to Date 2018 Financial Results:
About Rhythm Pharmaceuticals
Rhythm is a biopharmaceutical company focused on the development and commercialization of therapies for the treatment of rare genetic disorders of obesity. Rhythm is currently evaluating the efficacy and safety of setmelanotide, the Company’s first-in-class melanocortin-4 receptor (MC4R) agonist, in Phase 3 studies in patients with pro-opiomelanocortin (POMC) deficiency obesity (which includes deficiencies in both the POMC and PCSK1 genes) and leptin receptor (LEPR) deficiency obesity. Rhythm also supports The Genetic Obesity Project (www.GeneticObesity.com), which is dedicated to improving the understanding of severe obesity that results from specific genetic disorders. The company is based in Boston, MA.
Forward-Looking Statements
This press release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties, including statements regarding Rhythm’s expectations regarding its anticipated timing for filing of an NDA, its anticipated timing of initiation and enrollment for clinical trials and announcement of data, and expectations regarding the sufficiency of cash. Statements using word such as “expect”, “anticipate”, “believe”, “may”, “will” and similar terms are also forward looking statements. Such statements are subject to numerous risks and uncertainties, including but not limited to, our ability to enroll patients in clinical trials, the outcome of clinical trials, the impact of competition, the ability to achieve or obtain necessary regulatory approvals, the impact of changes in the financial markets and global economic conditions, risks associated with data analysis and reporting, our use of cash and expenses, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and quarterly reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise.
Rhythm Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
(Unaudited)
Three months ended June 30, | Six months ended June 30, | |||||||||||||||
2018
|
2017
|
2018
|
2017
|
|||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 8,584 | $ | 5,397 | $ | 20,870 | $ | 10,270 | ||||||||
Selling, general, and administrative | 6,437 | 1,357 | 11,152 | 2,873 | ||||||||||||
Total operating expenses | 15,021 | 6,754 | 32,022 | 13,143 | ||||||||||||
Loss from operations | (15,021 | ) | (6,754 | ) | (32,022 | ) | (13,143 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Revaluation of Series A Investor Instrument and Series A Investor Right/Obligation | — | (82 | ) | — | (82 | ) | ||||||||||
Interest income, net | 609 | 34 | 1,151 | 63 | ||||||||||||
Total other income (expense): | 609 | (48 | ) | 1,151 | (19 | ) | ||||||||||
Net loss and comprehensive loss | $ | (14,412 | ) | $ | (6,802 | ) | $ | (30,871 | ) | $ | (13,162 | ) | ||||
Net loss attributable to common stockholders | $ | (14,412 | ) | $ | (8,008 | ) | $ | (30,871 | ) | $ | (15,534 | ) | ||||
Net loss attributable to common stockholders per common share, basic and diluted | $ | (0.52 | ) | $ | (0.79 | ) | $ | (1.12 | ) | $ | (1.52 | ) | ||||
Weighted average common shares outstanding, basic and diluted | 27,960,664 | 10,196,292 | 27,624,271 | 10,196,292 |
Rhythm Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
(Unaudited) | ||||||||
June 30, | December 31, | |||||||
2018
|
2017
|
|||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 210,484 | $ | 34,236 | ||||
Short-term investments | 77,070 | 113,846 | ||||||
Prepaid expenses and other current assets | 3,217 | 2,589 | ||||||
Total current assets | 290,771 | 150,671 | ||||||
Property, plant and equipment, net | 728 | 840 | ||||||
Restricted cash | 250 | 225 | ||||||
Total assets | $ | 291,749 | $ | 151,736 | ||||
Liabilities, convertible preferred stock and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 3,312 | $ | 2,427 | ||||
Deferred rent | 86 | 83 | ||||||
Accrued expenses and other current liabilities | 3,849 | 4,210 | ||||||
Total current liabilities | 7,247 | 6,720 | ||||||
Long-term liabilities: | ||||||||
Deferred rent | 185 | 228 | ||||||
Total liabilities | 7,432 | 6,948 | ||||||
Commitments and contingencies | ||||||||
Preferred stock: | ||||||||
Convertible Preferred Stock, $0.001 par value: 10,000,000 shares authorized; no shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively | — | — | ||||||
Stockholders’ equity: | ||||||||
Common stock, $0.001 par value: 120,000,000 shares authorized; 34,173,137 and 27,284,140 shares issued and outstanding June 30, 2018 and December 31, 2017, respectively | 34 | 27 | ||||||
Additional paid-in capital | 425,406 | 255,013 | ||||||
Accumulated deficit | (141,123 | ) | (110,252 | ) | ||||
Total stockholders’ equity | 284,317 | 144,788 | ||||||
Total liabilities, convertible preferred stock and stockholders’ equity | $ | 291,749 | $ | 151,736 |
Investor Contact:
Hannah Deresiewicz
Stern Investor Relations, Inc.
212-362-1200
hannahd@sternir.com
Media Contact:
Adam Daley
Berry & Company Public Relations
212-253-8881
adaley@berrypr.com