Bayer and actress Melissa Joan Hart are partnering to raise awareness about Lynkuet^® (elinzanetant) 60mg capsules, a hormone-free prescription treatment for the reduction of moderate to severe hot flashes due to menopause,¹ and encourage women to talk with their healthcare provider about treatment options.

Key Points:

• Melissa Joan Hart partners with Bayer to help raise awareness about moderate to severe hot flashes due to menopause and to encourage women to discuss treatment options with their healthcare providers.
• Lynkuet^® (elinzanetant) 60mg capsules is an FDA-approved, hormone-free prescription treatment for the reduction of moderate to severe hot flashes due to menopause.¹

Bayer today announced a partnership with actress and menopause advocate Melissa Joan Hart to increase awareness about Lynkuet^® (elinzanetant) 60mg capsules, Bayer’s FDA-approved, hormone-free prescription treatment for moderate to severe hot flashes due to menopause.¹ Through the partnership, Hart will share her personal experience with moderate to severe hot flashes due to menopause to help women recognize their symptoms and to encourage more proactive treatment conversations with their healthcare providers.

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Hot flashes are among the most common symptoms of menopause.² Hot flashes can impact women differently³ and some, when severe can be disruptive.⁴ As a hormone-free treatment option, Lynkuet reduces moderate to severe hot flashes due to menopause.¹ In clinical trials measuring efficacy at weeks 4 and 12, women experiencing moderate to severe hot flashes who took Lynkuet had fewer and less severe hot flashes, day and night. Some women experienced fewer hot flashes in as early as one week although individual results may vary.⁵ Please see below for Important Safety Information for Lynkuet.

“I thought my days of waking up in the middle of the night were behind me after raising my kids. Then menopause came along. I knew hot flashes could happen, but I didn't expect them to affect me the way they did. I found myself sometimes waking up at night, this time not because of my kids, but because of severe hot flashes,” said Melissa Joan Hart. “I know I’m not the only woman who has experienced moderate to severe hot flashes due to menopause. I hope sharing my experience encourages women to talk openly with their healthcare providers about their symptoms and treatment options, like Lynkuet.”

As the one year anniversary of the FDA approval of Lynkuet approaches, Hart joins Bayer’s “Life Doesn’t Stop for a Hot Flash” campaign. Though Hart is not a Lynkuet patient, she is helping to raise awareness about Lynkuet and encourage women to learn more about their treatment options through multiple initiatives including a Reddit Ask Me Anything campaign.

“Since the FDA approval of Lynkuet in October 2025, Bayer has been working with healthcare providers, menopause advocates, and experts and Lynkuet patients to help open up conversations about moderate to severe hot flashes due to menopause and ensure women are aware treatment options are available," said Amy Hessels, Vice President, Women’s Healthcare Marketing at Bayer. "Partnering with Melissa Joan Hart will further our efforts to help break down barriers and fuel important conversations about hot flashes.”

To learn more about the campaign and to access the Lynkuet discussion guide for tips on discussing moderate to severe hot flashes due to menopause with your healthcare provider, visit lynkuet.com.

Product Indication and Important Safety Information

INDICATION

What is LYNKUET^® (elinzanetant)?
LYNKUET is a prescription medicine used to reduce moderate to severe hot flashes (also known as vasomotor symptoms) due to menopause. LYNKUET is not a hormone. Hot flashes are feelings of warmth in the face, neck, and chest, or sudden intense feelings of heat and sweating.

IMPORTANT SAFETY INFORMATION

Do not take LYNKUET if you:

• are pregnant

Before you use LYNKUET, tell your healthcare provider about all of your medical conditions, including if you:

• have liver problems
• have a history of seizures or have a condition that may increase your risk of having a seizure
• are pregnant or planning to become pregnant. LYNKUET may harm your unborn baby. Women who can become pregnant should talk to their healthcare provider to exclude pregnancy before starting treatment with LYNKUET and use effective birth control during and for 2 weeks after stopping treatment.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LYNKUET may affect the way other medicines work, and other medicines may affect how LYNKUET works.

What should I avoid while taking LYNKUET?

• Avoid eating grapefruit or drinking grapefruit juice during treatment with LYNKUET.
• LYNKUET may cause you to feel drowsy, if you experience this avoid driving and other hazardous activities until these effects go away.

LYNKUET can cause serious side effects, including:

• Central nervous system (CNS) effects and daytime impairment. LYNKUET can cause difficulty staying awake (somnolence) and other nervous system effects including fatigue, having a spinning feeling (vertigo), dizziness, and feeling faint (presyncope). If you experience these effects, you should not drive or do hazardous activities until these effects go away.
• Increased liver blood test values. LYNKUET may cause increased liver enzymes. Your healthcare provider will do a blood test to check your liver before you start and 3 months after taking LYNKUET. Stop taking LYNKUET and tell your healthcare provider right away if you have the following signs or symptoms that suggest liver problems:
  • feeling more tired than you do usually
  • decreased appetite
  • nausea
  • vomiting
  • itching
  • yellowing of the eyes or skin (jaundice)
  • pale feces
  • dark urine
  • pain in the stomach (abdomen)
• Risk of pregnancy loss. Taking LYNKUET while pregnant may cause loss of pregnancy or stillbirth. If you think you are pregnant, stop taking LYNKUET and tell your healthcare provider right away.
• Risk of seizure. Seek medical attention right away if you have loss of consciousness or seizure.

Common side effects of LYNKUET include:

• headache
• fatigue
• dizziness
• feeling drowsy or sleepy
• stomach (abdominal) pain
• rash
• diarrhea
• muscle spasms

Tell your healthcare provider if you have any side effects that do not go away. These are not all the possible side effects of LYNKUET.

LYNKUET is available by prescription only.

You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088. For Bayer products, you can report these directly to Bayer by clicking here

For important information about LYNKUET, please see the Full Prescribing Information

About Lynkuet^® (elinzanetant)
Lynkuet^® (elinzanetant) 60mg capsules is an FDA-approved, hormone-free prescription treatment for moderate to severe hot flashes due to menopause. Lynkuet is the first and only dual neurokinin (NK) targeted therapy, neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist approved for the treatment of moderate to severe hot flashes due to menopause. If a patient cannot afford their prescription, Bayer may be able to help. Eligible patients may receive their Bayer prescription medicine at no cost through the Bayer U.S. Patient Assistance Foundation. For more information, please visit www.patientassistance.bayer.us or call to speak with a member of Bayer’s team at 1-866-2BUSPAF (228-7723).

About the OASIS-1, 2 and 3 trials
The FDA approval of Lynkuet^® (elinzanetant) 60mg capsules is supported by data from three Phase III clinical trials that evaluated the safety and efficacy of Lynkuet for the treatment of moderate to severe hot flashes due to menopause. The efficacy of Lynkuet for the treatment of moderate to severe hot flashes due to menopause was demonstrated in the first 12 weeks of two randomized, double-blind, placebo-controlled, multicenter clinical trials, OASIS-1 and OASIS-2, in 796 menopausal women. The co-primary efficacy endpoints in both trials were the mean change in frequency and severity of moderate to severe hot flashes from baseline to weeks 4 and 12, including day and night hot flashes. The safety of Lynkuet was evaluated in three randomized, double-blind, placebo-controlled, multicenter clinical trials (OASIS-1, OASIS-2 and OASIS-3) in 1,420 women. In OASIS-3, 627 women received Lynkuet or placebo for up to 52 weeks to evaluate long-term safety.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros.

Find more information at www.pharma.bayer.com
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Disclosures
Melissa Joan Hart is a paid Bayer spokesperson and has been compensated for her time. She is not taking Lynkuet.

References
¹ LYNKUET^® (elinzanetant) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; August 2026.
² Thurston RC, Joffe H. Vasomotor symptoms and menopause: findings from the Study of Women's Health across the Nation. Obstet Gynecol Clin North Am. 2011;38(3):489-501.
³ Shepherd JA, Shiozawa A, Schild AL, et. al. Retrospective text and qualitative analyses of patient experience and management of vasomotor symptoms due to menopause: voices from the PatientsLikeMe community. Menopause. 2024;31(9):789-795.
⁴ US Food and Drug Administration. Estrogen and estrogen/progestin drug products to treat vasomotor symptoms and vulvar and vaginal atrophy. FDA. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/estrogen-and-estrogenprogestin-drug-products-treat-vasomotor-symptoms-and-vulvar-and-vaginal-atrophy. Accessed October 23, 2025.
⁵ Pinkerton JV, Simon JA, Joffe H, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS 1 and 2 randomized clinical trials. JAMA. 2024;332(16):1343-1354. doi:10.1001/jama.2024.14618

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