Rhythm Pharmaceuticals Announces New Employment Inducement Grants

BOSTON, Jan. 05, 2023 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) pathway diseases, today announced that on January 3, 2023, the Compensation Committee of Rhythm’s board of directors granted inducement equity grants covering an aggregate of 18,975 shares of its common stock to three new employees, consisting of inducement stock options to purchase an aggregate of 12,650 shares of common stock and inducement restricted stock units, or RSUs, covering an aggregate of 6,325 shares of its common stock.

These inducement stock options, and inducement RSUs, are subject to the terms and conditions of the Rhythm Pharmaceuticals, Inc.2022 Employment Inducement Plan (“Inducement Plan”)

The Inducement Plan is only used to grant equity awards to individuals to induce them to work with Rhythm. This is pursuant to Nasdaq Listing Rule 563(c)(4). The Inducement Plan was adopted by Rhythm’s board of directors on February 9, 2022.

Stock options can be exercised at a price of $ 28.64 per share. Each option will become fully exercisable at 25% on the anniversary of the date that the option was granted. The remaining 75% of the options will become fully exercisable in 12 equal quarterly increments over the following three years. Employees must continue to work on each vesting date. The RSUs vest over four years, with 25% of the shares vesting on each anniversary of the applicable date of hire, subject to each such employee’s continued employment on each vesting date.

About Rhythm Pharmaceuticals
Rhythm is a biopharmaceutical company at the commercial stage. It is committed to improving the lives of patients with severe melanocortin-4-related (MC4R), hyperphagia, and other related disorders. Rhythm’s precision medicine, setmelanotide, is approved 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 monogenic or syndromic obesity due to pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency confirmed by genetic testing, or patients with a clinical diagnosis of Bardet-Biedl syndrome (BBS). The European Commission (EC) and Great Britain’s Medicines & Healthcare Products Regulatory Agency (MHRA) have authorized setmelanotide for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 6 years of age and above. Rhythm is also working on a wide-ranging clinical development program for setmelanotide. It is also leveraging the Rhythm Engine, the largest known database of obesity DNA samples, and the Rhythm Engine to better understand, diagnose, and provide care to people with severe obesity caused by certain genetic deficiencies. Rhythm’s headquarters is in Boston, MA.

Setmelanotide Indication
In the United States, setmelanotide is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to POMC, PCSK1 or LEPR deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1 or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS) or BBS.

In the European Union, setmelanotide is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS) or genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 6 years of age and above.

Limitations
In the United States and Europe, Setmelanotide should be prescribed and supervised by a physician with expertise in obesity with underlying genetic etiology.

Patients suffering from the following conditions are not recommended to receive setmelanotide. It is unlikely that the drug would be effective in treating them.

• Obesity caused by a POMC, PCSK1 and LEPR deficiency POMC, PCSK1 Oder LEPR Types of variants that are likely or benign

• Other types or obesity, not related to POMC/PCSK1 or LEPR deficiencies or BBS. This includes obesity associated with genetic syndromes or general (polygenic).

WARNINGS and PRECAUTIONS

Skin Monitoring: Setmelanotide may lead to generalized increased skin pigmentation and darkening of pre-existing naevi because of its pharmacologic effect. To monitor any skin pigmentary changes, including those that have been pre-existing or new to setmelanotide treatment, it is important to conduct annual skin examinations.

Monitor heart rate and bloodpressure Patients receiving setmelanotide must have their blood pressure and heart rate monitored during every visit. This is at least once every 6 months.

Prolonged penile erection: Clinical trials with setmelanotide have shown that spontaneous penile erections can occur. Patients experiencing a prolonged penile erection that lasts more than four hours should seek immediate medical attention to treat priapism.

Depression: In clinical trials, depression has been reported in patients treated with setmelanotide. Patients suffering from depression should be closely monitored during setmelanotide treatment. If patients have suicidal thoughts, or behavior, it is worth considering discontinuing setmelanotide.

The Pediatric Population Setmelanotide therapy should be monitored by the prescribing physician. The impact of weight loss on maturation and growth should be assessed in growing children. The prescribing physician should track growth (height, weight) using age- and sexually-appropriate growth curves.

Excipients: Each ml contains 10 mg of benzyl alcohol. Allergy reactions may occur when benzyl alcohol is consumed. The potential danger from the excipient of benzylalcool, which could accumulate over time and cause metabolic alkalosis, should be made known to pregnant women or nursing mothers. Patients suffering from hepatic and renal impairment should avoid this medicinal product. There is a potential risk that the excipient, benzylalcool, might accumulate over time and cause metabolism acidosis.

Sodium: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free.”

ADVERSE REACTIONS
Most common adverse reactions include hyperpigmentation (51%), inject site reaction (39%), nausea 33%, and headache (26%).

USE IN SPECIFIC PUPPULATIONS

Pregnancy
Setmelanotide use in pregnancy has not been proven to be safe. Animal studies have not shown any evidence of reproductive toxicities. Setmelanotide administration to pregnant rabbits led to decreased maternal food intake, which could have embryo-foetal consequences. Setmelanotide should be avoided during pregnancy and while trying to get pregnant. Weight loss may cause fetal harm. Setmelanotide should not be stopped if a patient has reached stable weight and is pregnant. There was no evidence of teratogenicity from the nonclinical data. If setmelanotide is being used and the patient continues to lose weight, the dosage should be decreased or discontinued. However, the doctor should monitor for any weight gain during pregnancy. Setmelanotide patients should be closely monitored by their treating physician during pregnancy.

Breast-feeding
It is unknown if setmelanotide is found in human milk. Nonclinical research has shown that setmelanotide was excreted from the milk of nursing rats. Plasma from nursing puppies did not contain any setmelanotide. There is no way to exclude the possibility of a risk for the infant/newborn. The mother must decide whether to discontinue or abstain from breastfeeding, taking into account both the benefits to her child and the mother’s health.

Fertility
We do not have any data from humans on the effects setmelanotide has on fertility. Animal studies didn’t show any harmful effects on fertility.

To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +1 (833) 789-6337. Please see Summary of Product Characteristics’ APPENDIX V For a complete list of European reporting systems, click here

For additional safety information, please refer to the complete Prescribing Information.

Forward-looking Statements
This press release contains forward looking statements as defined by the Private Securities Litigation Reform Act of 1996. Forward-looking statements are any statements in this press release which do not relate directly to historical facts should be considered. These statements include statements about setmelanotide’s potential safety, efficacy, regulatory and clinical progress, regulatory submissions, approvals or timing thereof and our business strategy. This includes statements regarding commercialization of IMCIVREE. 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, our ability to successfully commercialize setmelanotide, 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 three months ended September 30, 2022 and our other filings with the Securities and Exchange Commission. Except as required under law, we are not obliged to make any changes to forward-looking information in this release. We also cannot update them to reflect new information or circumstances.

Contact us at Corporate:
David Connolly
Head of Investor Relations and Corporate Communications
Rhythm Pharmaceuticals, Inc.
857-264-4280
[email protected]

Contact Investors
Hannah Deresiewicz
Stern Investor Relations, Inc.
212-362-1200
[email protected]

Contact Media
Adam Daley
Berry & Company Public Relations
212-253-8881
[email protected]