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- Announced updated clinical data from Phase 2 basket study of setmelanotide in MC4R pathway heterozygous (HET) obesity, demonstrating consistent weight and hunger responses in patients with high-impact loss-of-function (LOF) variants -
- Announced strategy for further development in HET obesity with patients stratified into cohorts based on LOF variant -
- Topline data from pivotal Phase 3 trials evaluating setmelanotide in pro-opiomelanocortin (POMC) and leptin receptor (LEPR) deficiency obesity expected in the third quarter of 2019, followed by New Drug Application (NDA) filings -
BOSTON, May 03, 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 first quarter ended March 31, 2019.
“In the first quarter, we announced preliminary data and an updated clinical strategy in patients with HET obesity, which represents key progress as we seek to expand our pipeline into additional MC4R pathway deficiency obesities that may be setmelanotide-responsive. In parallel, we detailed ongoing efforts to leverage the Rhythm Engine -- comprised of our Phase 2 basket study, TEMPO Registry and GO-ID genotyping study -- to accelerate patient identification and develop a better understanding of the burden in people living with rare genetic disorders of obesity,” said Keith Gottesdiener, M.D., Chief Executive Officer of Rhythm. “We are now preparing for topline data readouts from our two ongoing pivotal Phase 3 trials of setmelanotide in POMC and LEPR deficiency obesities and the potential filing of our first NDAs with the U.S. Food and Drug Administration (FDA). In parallel, we are broadening our community engagement to support the potential launch of setmelanotide. We expect 2019 to be a transformative year for Rhythm, as we progress closer to our vision of delivering the first approved therapeutic for people living with rare genetic disorders of obesity.”
First Quarter and Recent Business Highlights:
Pipeline:
Upcoming Milestones:
First Quarter 2019 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 business strategy, its anticipated timing for enrollment and design of clinical trials, the timing for filing of new drug applications, the timing of information regarding efforts to identify patients, the release of results of clinical trials, and its expectations regarding the sufficiency to fund its operations. Statements using word such as “expect”, “anticipate”, “believe”, “may”, “will”, “plan” 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.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
Three months ended March 31, | |||||||||
2019 | 2018 | ||||||||
Operating expenses: | |||||||||
Research and development | $ | 22,761 | $ | 12,286 | |||||
Selling, general, and administrative | 7,759 | 4,715 | |||||||
Total operating expenses | 30,520 | 17,001 | |||||||
Loss from operations | (30,520) | (17,001) | |||||||
Other income (expense): | |||||||||
Interest income, net | 1,546 | 542 | |||||||
Total other income (expense): | 1,546 | 542 | |||||||
Net loss and comprehensive loss | $ | (28,974) | $ | (16,459) | |||||
Net loss attributable to common stockholders | $ | (28,974) | $ | (16,459) | |||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.84) | $ | (0.60) | |||||
Weighted average common shares outstanding, basic and diluted | 34,417,189 | 27,284,140 |
Rhythm Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
(Unaudited)
March 31, |
December 31, | |||||||
2019
|
2018
|
|||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 42,020 | $ | 49,542 | ||||
Short-term investments | 179,503 | 202,519 | ||||||
Prepaid expenses and other current assets | 8,646 | 6,628 | ||||||
Total current assets | 230,169 | 258,689 | ||||||
Property and equipment, net | 2,757 | 1,120 | ||||||
Right-of-use asset | 3,174 | — | ||||||
Restricted cash | 402 | 401 | ||||||
Total assets | $ | 236,502 | $ | 260,210 | ||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 3,992 | $ | 7,640 | ||||
Accrued expenses and other current liabilities | 8,373 | 5,942 | ||||||
Lease liability | 202 | — | ||||||
Total current liabilities | 12,567 | 13,582 | ||||||
Long-term liabilities: | ||||||||
Lease liability | 3,446 | — | ||||||
Deferred rent | — | 372 | ||||||
Total liabilities | 16,013 | 13,954 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ equity: | ||||||||
Preferred Stock, $0.001 par value: 10,000,000 shares authorized; no shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively | — | — | ||||||
Common stock, $0.001 par value: 120,000,000 shares authorized; 34,430,641 and 34,410,725 shares issued and outstanding March 31, 2019 and December 31, 2018, respectively | 34 | 34 | ||||||
Additional paid-in capital | 434,031 | 430,824 | ||||||
Accumulated deficit | (213,576) | (184,602) | ||||||
Total stockholders’ equity | 220,489 | 246,256 | ||||||
Total liabilities and stockholders’ equity | $ | 236,502 | $ | 260,210 | ||||
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