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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Rhythm Pharmaceuticals Inc | NASDAQ:RYTM | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-1.17 | -2.99% | 38.00 | 37.95 | 38.05 | 39.45 | 37.62 | 39.45 | 210,226 | 17:47:50 |
“We have made tremendous progress in the second quarter towards our goal of transforming the care of patients with rare genetic diseases of obesity globally,” said David Meeker, M.D., Chair, President and Chief Executive Officer of Rhythm. “We are pleased with our first full quarter of IMCIVREE® (setmelanotide) commercial availability in the United States with positive engagements with patients, prescribers and payors. We recently secured European Commission marketing authorization for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 6 years of age and above, enabling us to expand patient access to IMCIVREE. From a market access standpoint, we are encouraged that regulatory authorities, such as National Institute for Health and Care Excellence (NICE) in the United Kingdom, recognize these obesities as rare genetic diseases for which there are no available treatment options.”
Dr. Meeker continued, “In parallel, we are executing on our clinical development and regulatory strategy to bring setmelanotide to substantially more patients suffering from rare genetic diseases of obesity. We look forward to completing supplementary regulatory submissions in the second half of this year to both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), seeking marketing authorization for setmelanotide for Bardet-Biedl and Alström syndromes, and we are excited to continue advancing our broad clinical development program in additional patient populations. With agreement from both the FDA and EMA, we are poised to initiate five clinical trials of setmelanotide: the pivotal Phase 3 EMANATE trial with five sub-studies in heterozygous POMC, PCSK1 or LEPR deficiency obesities and SRC1 and SH2B1 deficiency obesities, the Phase 2 DAYBREAK trial in 31 additional genes each with strong or very strong ties to the MC4R pathway, as well as a Phase 3 pediatrics trial for children younger than 6 and two registrational trials for our weekly formulation of setmelanotide. Taken together, we believe these efforts may enable us to help many more people with rare genetic diseases of obesity with a potential treatment for their insatiable hunger or hyperphagia and early-onset, severe obesity.”
Second Quarter and Recent Business Highlights:
Pipeline and Business Developments:
POMC and LEPR Deficiency Obesities:
Bardet-Biedl Syndrome and Alström Syndrome:
Additional Clinical Development Updates:
Today, Rhythm announced it has reached agreement with the FDA and EMA on five new Phase 2 and Phase 3 clinical trials, all of which the Company expects to initiate in the second half of 2021:
Corporate
Key Upcoming Milestones:
Rhythm expects to achieve the following milestones in 2021:
Regulatory Milestones:
Additional Clinical Milestones:
Second Quarter 2021 Financial Results:
Year to Date 2021 Financial Results:
Financial Guidance: Based on its current operating plans, Rhythm expects that its existing cash, cash equivalents and short-term investments as of June 30, 2021, will be sufficient to fund its operating expenses and capital expenditure requirements into at least the second half of 2023.
Conference Call Information
Rhythm Pharmaceuticals will host a live conference call and webcast at 8:00 a.m. ET today to discuss this update, as well as review its second quarter 2021 financial results and recent business activities. The conference call may be accessed by dialing (844) 498-0570 (domestic) or (409) 983-9726 (international), and referring to conference ID 6776764. A webcast of the call will be available under "Events and Presentations" in the Investor Relations section of the Rhythm Pharmaceuticals website at http://ir.rhythmtx.com/. The archived webcast will be available on Rhythm Pharmaceuticals’ website approximately two hours after the conference call and will be available for 30 days following the call.
About Rhythm PharmaceuticalsRhythm is a commercial-stage biopharmaceutical company committed to transforming the treatment paradigm for people living with rare genetic diseases of obesity. The Company’s precision medicine, IMCIVREE (setmelanotide), was approved in November 2020 by the U.S. Food and Drug Administration (FDA) for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to POMC, PCSK1 or LEPR deficiency confirmed by genetic testing and by the European Commission (EC) in July 2021 for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 6 years of age and above. IMCIVREE is the first-ever FDA-approved and EC-authorized therapy for these rare genetic diseases of obesity. Rhythm is advancing a broad clinical development program for setmelanotide in other rare genetic diseases of obesity. The Company is leveraging the Rhythm Engine and the largest known obesity DNA database - now with approximately 37,500 sequencing samples - to improve the understanding, diagnosis and care of people living with severe obesity due to certain genetic deficiencies. The company is based in Boston, MA.
IMCIVREE® (setmelanotide) IndicationIn the United States, IMCIVREE is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. The condition must be confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).
In the EU, IMCIVREE is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 6 years of age and above. IMCIVREE should be prescribed and supervised by a physician with expertise in obesity with underlying genetic etiology.
Limitations of UseIMCIVREE is not indicated for the treatment of patients with the following conditions as IMCIVREE would not be expected to be effective:
Important Safety Information
WARNINGS AND PRECAUTIONS
Disturbance in Sexual Arousal: Sexual adverse reactions may occur in patients treated with IMCIVREE. Spontaneous penile erections in males and sexual adverse reactions in females occurred in clinical studies with IMCIVREE. Instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.
Depression and Suicidal Ideation: Some drugs that target the central nervous system, such as IMCIVREE, may cause depression or suicidal ideation. Monitor patients for new onset or worsening of depression. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors.
Skin Pigmentation and Darkening of Pre-Existing Nevi: IMCIVREE may cause generalized increased skin pigmentation and darkening of pre-existing nevi due to its pharmacologic effect. This effect is reversible upon discontinuation of the drug. Perform a full body skin examination prior to initiation and periodically during treatment with IMCIVREE to monitor pre-existing and new skin pigmentary lesions.
Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative in Neonates and Low Birth Weight Infants: IMCIVREE is not approved for use in neonates or infants.
ADVERSE REACTIONS
USE IN SPECIFIC POPULATIONSDiscontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.
Treatment with IMCIVREE is not recommended for use while breastfeeding.
To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +1 (833) 789-6337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See Full Prescribing Information for IMCIVREE.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential, safety, efficacy, and regulatory and clinical progress of setmelanotide, including the anticipated timing for initiation of clinical trials and release of clinical trial data and our expectations surrounding potential regulatory submissions, approvals and timing thereof, our business strategy and plans, including regarding commercialization of setmelanotide, our participation in upcoming events and presentations, and the sufficiency of our cash, cash equivalents and short-term investments to fund our operations. 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, the impact of our management transition, 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, our liquidity and expenses, the impact of the COVID-19 pandemic on our business and operations, including our preclinical studies, clinical trials and commercialization prospects, and general economic conditions, and the other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 and our other filings 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.
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)(in thousands, except share and per share data)(Unaudited)
Three months ended June 30, | Six months ended June 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Product revenue, net | $ | 274 | $ | — | $ | 309 | $ | — | ||||||||
Costs and expenses: | ||||||||||||||||
Cost of sales | 137 | — | 141 | — | ||||||||||||
Research and development | 25,104 | 22,997 | 45,015 | 45,501 | ||||||||||||
Selling, general, and administrative | 15,465 | 8,921 | 29,983 | 21,717 | ||||||||||||
Total costs and expenses | 40,706 | 31,918 | 75,139 | 67,218 | ||||||||||||
Loss from operations | (40,432 | ) | (31,918 | ) | (74,830 | ) | (67,218 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Other income | — | — | 100,000 | — | ||||||||||||
Interest income, net | 21 | 801 | 175 | 1,937 | ||||||||||||
Total other income, net | 21 | 801 | 100,175 | 1,937 | ||||||||||||
Income (loss) before taxes | (40,411 | ) | (31,117 | ) | 25,345 | (65,281 | ) | |||||||||
Provision for income taxes | (5,022 | ) | — | 16,984 | — | |||||||||||
Net income (loss) | $ | (35,389 | ) | $ | (31,117 | ) | $ | 8,361 | $ | (65,281 | ) | |||||
Net income (loss) per share | ||||||||||||||||
Basic | $ | (0.70 | ) | $ | (0.71 | ) | $ | 0.17 | $ | (1.48 | ) | |||||
Diluted | $ | (0.70 | ) | $ | (0.71 | ) | $ | 0.17 | $ | (1.48 | ) | |||||
Weighted-average common shares outstanding | ||||||||||||||||
Basic | 50,209,484 | 44,098,860 | 48,931,127 | 44,074,352 | ||||||||||||
Diluted | 50,209,484 | 44,098,860 | 49,644,704 | 44,074,352 | ||||||||||||
Other comprehensive income (loss): | ||||||||||||||||
Net income (loss) | $ | (35,389 | ) | $ | (31,117 | ) | $ | 8,361 | $ | (65,281 | ) | |||||
Unrealized (loss) gain on marketable securities | 79 | 567 | (28 | ) | 630 | |||||||||||
Comprehensive income (loss) | $ | (35,310 | ) | $ | (30,550 | ) | $ | 8,333 | $ | (64,651 | ) |
Rhythm Pharmaceuticals, Inc.Condensed Consolidated Balance Sheets(in thousands, except share and per share data)(Unaudited)
June 30, | December 31, | ||||||||||||||
2021 | 2020 | ||||||||||||||
Assets | |||||||||||||||
Current assets: | |||||||||||||||
Cash and cash equivalents | $ | 69,339 | $ | 100,854 | |||||||||||
Short-term investments | 298,815 | 71,938 | |||||||||||||
Prepaid expenses and other current assets | 10,300 | 8,876 | |||||||||||||
Total current assets | 378,454 | 181,668 | |||||||||||||
Property and equipment, net | 3,051 | 3,195 | |||||||||||||
Right-of-use asset | 1,671 | 1,807 | |||||||||||||
Intangible assets, net | 4,886 | — | |||||||||||||
Restricted cash | 328 | 403 | |||||||||||||
Total assets | $ | 388,390 | $ | 187,073 | |||||||||||
Liabilities and stockholders’ equity | |||||||||||||||
Current liabilities: | |||||||||||||||
Accounts payable | $ | 5,009 | $ | 4,900 | |||||||||||
Accrued expenses and other current liabilities | 11,880 | 12,559 | |||||||||||||
Lease liability | 570 | 535 | |||||||||||||
Total current liabilities | 17,459 | 17,994 | |||||||||||||
Long-term liabilities: | |||||||||||||||
Deferred tax liability | 16,984 | — | |||||||||||||
Lease liability | 2,258 | 2,551 | |||||||||||||
Total liabilities | 36,701 | 20,545 | |||||||||||||
Commitments and contingencies (Note 5) | |||||||||||||||
Stockholders’ equity: | |||||||||||||||
Preferred Stock, $0.001 par value: 10,000,000 shares authorized; no shares issued and outstanding at June 30, 2021 and December 31, 2020 | — | — | |||||||||||||
Common stock, $0.001 par value: 120,000,000 shares authorized; 50,226,739 and 44,235,903 shares issued and outstanding June 30, 2021 and December 31, 2020, respectively | 50 | 44 | |||||||||||||
Additional paid-in capital | 802,584 | 625,762 | |||||||||||||
Accumulated other comprehensive income | 21 | 49 | |||||||||||||
Accumulated deficit | (450,966 | ) | (459,327 | ) | |||||||||||
Total stockholders’ equity | 351,689 | 166,528 | |||||||||||||
Total liabilities and stockholders’ equity | $ | 388,390 | $ | 187,073 |
Corporate Contact:David ConnollyHead of Investor Relations and Corporate CommunicationsRhythm Pharmaceuticals, Inc.857-264-4280dconnolly@rhythmtx.com
Investor Contact:Hannah DeresiewiczStern Investor Relations, Inc.212-362-1200hannah.deresiewicz@sternir.com
Media Contact:Adam DaleyBerry & Company Public Relations212-253-8881adaley@berrypr.com
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