BOSTON, March 08, 2019 (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 fourth quarter and full year ended December 31, 2018.
“Our vision at Rhythm is to transform the care of obesity by delivering the first approved therapeutic for people living with rare genetic disorders of obesity due to impairments of the melanocortin-4 receptor (MC4R) pathway and building an integrated community of patients, caregivers, health care providers, and payors to better address these conditions,” said Keith Gottesdiener, M.D., Chief Executive Officer of Rhythm. “In 2018, we made important progress toward making this vision a reality. In addition to advancing setmelanotide into three pivotal trials, we shared new clinical data demonstrating setmelanotide’s ability to have dramatic impacts on weight and hunger in people with different MC4R pathway deficiencies and launched our TEMPO registry to gather critical information on the daily burden of rare genetic disorders of obesity on those affected.”
Dr. Gottesdiener continued, “As we look to 2019, we are excited to enter our next stage of growth, with topline data from our pivotal Phase 3 trials in pro-opiomelanocortin (POMC) and leptin receptor (LEPR) deficiency obesity expected in the third quarter, and our first new drug applications expected to follow in late 2019 or early 2020. In parallel, we will continue to further evaluate setmelanotide through advancing our ongoing pivotal trial in Bardet-Biedl syndrome (BBS) and Alström syndrome, reading out updated data from our Phase 2 basket study in POMC and other MC4R pathway heterozygous deficiency obesities and POMC epigenetic disorders, and expanding our clinical development pipeline to include patients with additional genetic targets tied to the MC4R pathway.”
Fourth Quarter and Recent Business Highlights:
Pipeline:
Upcoming Milestones:
Fourth Quarter and Full Year 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 MC4R agonist, in Phase 3 studies in patients with POMC deficiency obesity, LEPR deficiency obesity, BBS, and Alström syndrome. Rhythm is dedicated to improving the understanding of severe obesity that results from specific genetic disorders. For healthcare professionals, visit www.UNcommonObesity.com for more information. For patients and caregivers, visit www.LEADforRareObesity.com for more information. 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 anticipated timing for enrollment and design of clinical trials, the timing for filing of a new drug application, the release of results of clinical trials, and its 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 design and outcome of clinical trials, the impact of competition, the ability to achieve or obtain necessary regulatory approvals, risks associated with data analysis and reporting, 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.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
Three months ended December 31, | Year ended December 31, | ||||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||||
Operating expenses: | |||||||||||||||||
Research and development | $ | 18,763 | $ | 6,653 | $ | 50,337 | $ | 22,894 | |||||||||
Selling, general, and administrative | 8,388 | 4,330 | 28,080 | 9,518 | |||||||||||||
Total operating expenses | 27,151 | 10,983 | 78,417 | 32,412 | |||||||||||||
Loss from operations | (27,151 | ) | (10,983 | ) | (78,417 | ) | (32,412 | ) | |||||||||
Other income (expense): | |||||||||||||||||
Revaluation of Series A Investor Instrument and Series A Investor Right/Obligation | — | — | — | (1,863 | ) | ||||||||||||
Interest income, net | 1,644 | 452 | 4,353 | 566 | |||||||||||||
Total other income (expense): | 1,644 | 452 | 4,353 | (1,297 | ) | ||||||||||||
Net loss and comprehensive loss | $ | (25,507 | ) | $ | (10,531 | ) | $ | (74,064 | ) | $ | (33,709 | ) | |||||
Net loss attributable to common stockholders | $ | (25,507 | ) | $ | (10,619 | ) | $ | (74,064 | ) | $ | (37,582 | ) | |||||
Net loss attributable to common stockholders per common share, basic and diluted | $ | (0.74 | ) | $ | (0.41 | ) | $ | (2.39 | ) | $ | (2.83 | ) | |||||
Weighted average common shares outstanding, basic and diluted | 34,400,916 | 26,174,843 | 31,004,047 | 13,267,960 | |||||||||||||
Rhythm Pharmaceuticals, Inc.
Consolidated Balance Sheets
(in thousands, except share and per share data)
December 31, | December 31, | |||||||
2018 | 2017 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 49,542 | $ | 34,236 | ||||
Short-term investments | 202,519 | 113,846 | ||||||
Prepaid expenses and other current assets | 6,628 | 2,589 | ||||||
Total current assets | 258,689 | 150,671 | ||||||
Property, plant and equipment, net | 1,120 | 840 | ||||||
Restricted cash | 401 | 225 | ||||||
Total assets | $ | 260,210 | $ | 151,736 | ||||
Liabilities, convertible preferred stock and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 7,640 | $ | 2,427 | ||||
Deferred rent | — | 83 | ||||||
Accrued expenses and other current liabilities | 5,942 | 4,210 | ||||||
Total current liabilities | 13,582 | 6,720 | ||||||
Long-term liabilities: | ||||||||
Deferred rent | 372 | 228 | ||||||
Total liabilities | 13,954 | 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 December 31, 2018 and December 31, 2017, respectively | — | — | ||||||
Stockholders’ equity: | ||||||||
Common stock, $0.001 par value: 120,000,000 shares authorized; 34,410,725 and 27,284,140 shares issued and outstanding December 31, 2018 and December 31, 2017, respectively | 34 | 27 | ||||||
Additional paid-in capital | 430,824 | 255,013 | ||||||
Accumulated deficit | (184,602 | ) | (110,252 | ) | ||||
Total stockholders’ equity | 246,256 | 144,788 | ||||||
Total liabilities, convertible preferred stock and stockholders’ equity | $ | 260,210 | $ | 151,736 |
Investor Contact:
Hannah Deresiewicz
Stern Investor Relations, Inc.
212-362-1200
hannah.deresiewicz@sternir.com
Media Contact:
Adam Daley
Berry & Company Public Relations
212-253-8881
adaley@berrypr.com