Relmada Therapeutics | research notes

Introducing Relmada Therapeutics: A Pioneer in Mental Health Innovation

Overview:

Relmada Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing and commercializing transformative therapies for mental health disorders. With a focus on novel molecular targets and innovative drug delivery systems, Relmada aims to address unmet medical needs in the treatment of major depressive disorder (MDD) and schizophrenia.

Pipeline and Development Programs:

• Relmada 20: An oral, sublingual film formulation of dextromethorphan and bupropion. Relmada 20 is currently in Phase 3 clinical trials for the treatment of MDD.
• RM-196: A deuterated form of dextromethorphan, designed to prolong its duration of action and reduce side effects. RM-196 is in Phase 2 clinical trials for the treatment of schizophrenia.
• RM-105: A non-opioid, non-hallucinogenic NMDA receptor antagonist. RM-105 is in Phase 1 clinical trials for the treatment of MDD.

Mechanism of Action:

• Dextromethorphan and Bupropion: Relmada 20 combines the cough suppressant dextromethorphan with the antidepressant bupropion. Dextromethorphan acts as an NMDA receptor antagonist, while bupropion is a norepinephrine and dopamine reuptake inhibitor.
• RM-196: Deuteration of dextromethorphan slows its metabolism, resulting in a longer duration of action and reduced side effects compared to traditional dextromethorphan.
• RM-105: RM-105 is a novel NMDA receptor antagonist that has shown promising efficacy in preclinical models of depression.

Unmet Medical Need:

• MDD is a debilitating condition affecting millions of people worldwide. Despite available treatments, many patients experience inadequate symptom relief or intolerable side effects.
• Schizophrenia is a severe and persistent mental health disorder characterized by hallucinations, delusions, and cognitive impairment. Current treatments often have limited efficacy and can cause significant side effects.

Competitive Landscape:

Relmada Therapeutics faces competition from established pharmaceutical companies and emerging biotechs developing novel treatments for mental health disorders. However, the company's focus on innovative drug delivery systems and novel molecular targets differentiates its pipeline and positions it as a potential leader in the field.

Conclusion:

Relmada Therapeutics is a promising company with a strong pipeline of innovative therapies for mental health disorders. By leveraging novel molecular targets and cutting-edge drug delivery systems, Relmada has the potential to revolutionize the treatment of MDD and schizophrenia, addressing unmet medical needs and improving the lives of patients.

Business Model of Relmada Therapeutics

Relmada Therapeutics is a biopharmaceutical company that focuses on developing and commercializing novel therapies for neuropsychiatric diseases. Its business model revolves around the following key components:

Drug Development and Commercialization:

• Relmada develops and licenses novel therapeutics, primarily targeting conditions such as depression, anxiety, and substance use disorders.
• It conducts clinical trials to evaluate the safety and efficacy of its drug candidates.
• Upon regulatory approval, Relmada commercializes these treatments through its sales force and distribution network.

Licensing and Partnerships:

• Relmada licenses intellectual property related to its drug candidates from research institutions and companies.
• It forms strategic partnerships with other pharmaceutical companies to co-develop and commercialize its products.

Research and Development:

• Relmada invests heavily in research and development (R&D) to identify and develop promising drug candidates.
• Its focus is on neuropsychiatric diseases with high unmet medical needs.

Advantages to Competitors

Relmada Therapeutics has several advantages over its competitors in the neuropsychiatric drug development space:

Novel Drug Candidates:

• Relmada possesses a pipeline of novel and promising drug candidates targeting unique mechanisms of action.
• Its lead candidate, REL-1017, is designed to inhibit the synaptic activity of N-methyl-D-aspartate (NMDA) receptors, which may provide a novel approach to treating depression.

Deep Scientific Expertise:

• Relmada's team has extensive scientific expertise in neuropsychiatric diseases and drug development.
• This expertise enables the company to identify and advance promising drug candidates efficiently.

Focus on Unmet Needs:

• Relmada targets neuropsychiatric diseases with high unmet medical needs, where existing treatments are often inadequate or have significant side effects.
• By addressing these underserved areas, Relmada has the potential to make a substantial impact on patients' lives.

Targeted Licensing Strategy:

• Relmada's licensing strategy allows it to acquire promising drug candidates from external sources, expanding its portfolio and enhancing its pipeline.
• This strategy provides access to innovative technologies and reduces the risk associated with drug development.

Partnerships for Commercialization:

• Relmada's partnerships with pharmaceutical companies enable it to access broader markets and leverage their commercialization capabilities.
• These partnerships provide scale and expertise in areas such as sales, marketing, and distribution.

By capitalizing on these advantages, Relmada Therapeutics aims to establish itself as a leading player in the development and commercialization of novel therapies for neuropsychiatric diseases.

Outlook of Relmada Therapeutics

Company Overview

Relmada Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel, non-opioid therapies for the treatment of pain and other central nervous system (CNS) disorders.

Pipeline

Relmada's pipeline includes two lead drug candidates:

• RLM-007: A non-opioid, small molecule, oral selective mu-opioid receptor agonist candidate for the treatment of acute pain, post-operative pain, and other pain indications.
• RLM-012: A non-opioid, small molecule, oral selective nociceptin/orphanin FQ peptide (NOP) receptor agonist candidate for the treatment of chronic pain, fibromyalgia, and other CNS disorders.

Clinical Trials

RLM-007

• Phase 2b clinical trial in post-operative bunionectomy pain (RELEVANT-2) has completed enrollment.
• Phase 2a clinical trial in moderate-to-severe acute pain (RELEVANT-1) demonstrated positive topline results.
• Phase 2a clinical trial in post-operative knee replacement pain (RELEVANT-3) is ongoing.

RLM-012

• Phase 2a clinical trial in chronic pain (RELIANT-1) has completed enrollment.
• Phase 2a clinical trial in fibromyalgia (RELIANT-2) is ongoing.

Market Opportunity

• Pain: Globally, chronic pain affects approximately 1.5 billion people, while acute pain is experienced by millions of individuals annually.
• Non-Opioid Pain Therapeutics: There is a significant unmet medical need for non-opioid therapies due to the risks and limitations associated with opioids, such as addiction, abuse, and overdose.
• Nociceptin/NOP Receptor Agonists: NOP receptor agonists have demonstrated potential in preclinical studies and early clinical trials for the treatment of chronic pain and other CNS disorders.

Financial Outlook

• Relmada has a cash, cash equivalents, and investments balance of approximately $110 million as of September 30, 2022.
• The company projects sufficient cash runway to fund operations into mid-2024.

Analyst Ratings

Analysts generally have a positive outlook on Relmada Therapeutics, with the following ratings:

• Cowen: Outperform
• Cantor Fitzgerald: Overweight
• Raymond James: Outperform
• SVB Leerink: Outperform

Key Risks and Considerations

• Clinical trial outcomes: Results from ongoing clinical trials may not be positive or meet expectations.
• Regulatory approval: Relmada's drug candidates must obtain regulatory approval before they can be commercialized.
• Competition: There are numerous competitors in the pain therapeutics market, including other non-opioid and opioid therapies.
• Funding: Relmada may need to raise additional capital to support its ongoing clinical and commercial activities.

Conclusion

Relmada Therapeutics has a promising pipeline of non-opioid pain therapeutics, targeting a significant unmet medical need. The company has encouraging clinical data and a strong financial position that supports its ongoing development activities. However, as with any clinical-stage biopharmaceutical company, there are risks and uncertainties that could impact the company's outlook. Overall, analysts have a positive view of Relmada's potential and believe that it is well-positioned for future growth and success.

Similar Companies to Relmada Therapeutics

1. Axsome Therapeutics (https://www.axsome.com/)

• Why customers may like it: Developing novel drugs for central nervous system disorders, including depression, migraine, and narcolepsy.
• Strengths: Experienced management team with a track record of success in drug development.

2. MindMed (https://www.mindmed.co/)

• Why customers may like it: Focused on developing psychedelic-based therapies for mental health conditions.
• Strengths: Access to proprietary compounds and a pipeline of innovative treatments.

3. Cassava Sciences (https://www.cassavasciences.com/)

• Why customers may like it: Developing novel therapies for Alzheimer's disease and other neurodegenerative conditions.
• Strengths: Promising clinical data for lead candidate, simufilam, and a strong scientific team.

4. Corvus Pharmaceuticals (https://www.corvuspharma.com/)

• Why customers may like it: Developing precision oncology therapies, including immunotherapies and small molecule inhibitors.
• Strengths: Innovative drug discovery platform and a pipeline of potential blockbuster drugs.

5. Voyager Therapeutics (https://www.voyagertherapeutics.com/)

• Why customers may like it: Developing gene therapies for neurodegenerative and central nervous system diseases.
• Strengths: Proprietary gene editing technology and a focus on rare genetic disorders.

Founding and Early Years (2014-2017)

• 2014: Relmada Therapeutics was founded by Michael Ryan, a former executive at GlaxoSmithKline (GSK).
• The company's initial focus was on developing treatments for central nervous system (CNS) disorders.
• Relmada acquired an early-stage drug candidate, RL-007, from GSK.

Clinical Development and Partnerships (2018-2020)

• 2018: Relmada initiated a Phase 2 clinical trial of RL-007 for the treatment of major depressive disorder (MDD).
• The company entered into a collaboration with Ionis Pharmaceuticals to develop antisense oligonucleotides targeting gene expression in the CNS.
• Relmada raised $125 million in a Series C financing round.

IPO and Pipeline Expansion (2021-present)

• 2021: Relmada Therapeutics conducted an initial public offering (IPO), raising $276 million.
• The company expanded its pipeline to include candidates for treating post-traumatic stress disorder (PTSD), obsessive-compulsive disorder (OCD), and autism spectrum disorder (ASD).
• Relmada acquired the rights to RL-023, an investigational therapy for MDD, from a Danish biotechnology company.

Current Status

• Relmada Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel treatments for CNS disorders.
• The company has a pipeline of several drug candidates in clinical trials for MDD, PTSD, OCD, and ASD.
• Relmada's lead candidate, RL-007, is currently in Phase 3 clinical trials for MDD.

Key Milestones

• 2014: Founding of the company
• 2018: Initiation of Phase 2 clinical trial of RL-007
• 2021: IPO and pipeline expansion
• 2023: Phase 3 clinical trials of RL-007 ongoing

Last Three Years

2020

• January: Announced partnership with Takeda to develop and commercialize REL-1017 (later renamed deucefagin) for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
• May: Received FDA Fast Track designation for deucefagin in MDD and PPD.
• September: Initiated Phase 3 clinical trials (MOUNTAIN and RESTORATION) for deucefagin in MDD.

2021

• April: Announced positive topline results from the MOUNTAIN and RESTORATION trials, showing that deucefagin met the primary endpoint of statistically significant reduction in depressive symptoms compared to placebo.
• August: Submitted NDA (New Drug Application) to the FDA for deucefagin in MDD and PPD.

2022

• March: FDA grants priority review status to the NDA for deucefagin.
• April: Received EMA (European Medicines Agency) orphan drug designation for deucefagin in PPD.
• June: FDA issues Complete Response Letter (CRL) for the NDA for deucefagin, requesting additional data on long-term safety and efficacy.

Recent Timelines

• August 2022: Relmada announces plans to submit a Type C meeting request to the FDA to discuss the CRL and path forward for deucefagin.
• October 2022: Relmada announces appointment of new CEO, Michael Piasecki.
• March 2023: Relmada announces a $125 million private placement to support continued development of deucefagin.

Relmada Therapeutics: A Beacon of Hope in Mental Health

My journey with Relmada Therapeutics has been transformative. As someone who has struggled with depression for years, I had lost hope in finding a solution that truly worked. But Relmada has reignited that hope.

Their innovative approach to drug development has led to the creation of a novel medication that targets the underlying mechanisms of depression. After just a few weeks of treatment, I noticed a significant improvement in my mood, energy levels, and overall well-being.

What sets Relmada apart is their unwavering commitment to patient care. Their team of experts is dedicated to providing personalized treatment plans and ongoing support. They truly listen to their patients and work tirelessly to find the best possible solution for each individual.

The company's dedication to research and development is evident in their robust pipeline of promising new treatments. They are constantly pushing the boundaries of mental health care, offering hope to millions who have suffered for far too long.

The impact of Relmada Therapeutics on my life has been profound. I am now able to fully engage in my personal and professional pursuits, something I had thought impossible just a few months ago. I am eternally grateful for their work and highly recommend their services to anyone struggling with mental health issues.

In a world where mental health has long been stigmatized and underserved, Relmada Therapeutics is a shining beacon of hope. Their innovative treatments, compassionate care, and unwavering dedication are changing lives for the better.

Unlock the Power of Neuroscience: Discover Relmada Therapeutics Today!

Are you seeking cutting-edge advancements in the realm of neuroscience? Look no further than Relmada Therapeutics, a leading biotechnology company dedicated to unraveling the mysteries of the brain and developing transformative therapies for devastating neuropsychiatric disorders.

Our Mission: Revolutionizing Mental Healthcare

At Relmada, our unwavering mission is to empower patients with debilitating mental health conditions by harnessing the latest scientific breakthroughs. We believe that through rigorous research and unwavering dedication, we can unlock the potential of the brain and alleviate the suffering caused by neuropsychiatric disorders.

Pioneering Treatments: Targeting the Root Cause

Our pipeline of innovative therapies targets the underlying biological mechanisms responsible for neuropsychiatric disorders. Unlike traditional treatments that merely alleviate symptoms, Relmada's therapies aim to address the root cause, restoring brain function and improving patients' lives.

Our Flagship: REL-1017

Our flagship drug candidate, REL-1017, is a groundbreaking therapy for treatment-resistant depression (TRD). TRD is a debilitating condition that affects millions worldwide, and current treatments often fail to provide meaningful relief. REL-1017 has demonstrated promising results in clinical trials, offering hope to patients who have struggled to find effective solutions.

A Team of Experts: Leading the Way in Neuroscience

Relmada Therapeutics is led by a team of world-renowned scientists and clinicians who are passionate about advancing neuropsychiatric research. Our team is dedicated to translating scientific discoveries into real-world therapies that make a tangible difference in the lives of patients.

Visit Our Website: Explore the Frontiers of Neuroscience

Learn more about the exciting work we are doing at Relmada Therapeutics by visiting our website at [Website Link]. You will find detailed information on our research, clinical trials, and commitment to improving mental healthcare.

Join the Movement: Empowering Patient Recovery

We invite you to join us on this transformative journey as we strive to revolutionize the treatment of neuropsychiatric disorders. By supporting Relmada Therapeutics, you are helping to empower patients and their loved ones, unlocking the potential of the brain, and creating a brighter future for mental health.

About Relmada Therapeutics

Relmada Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapies for neuropsychiatric disorders. Our mission is to discover, develop, and deliver transformative therapies that improve the lives of patients and families affected by debilitating mental health conditions. For more information, please visit our website at [Website Link].

Main Supplier of Relmada Therapeutics

Name: Catalent, Inc.

Website: https://www.catalent.com/

Overview:

Catalent is a leading global provider of integrated solutions for the development, manufacturing, and supply of drugs, biologics, cell therapies, and consumer health products. The company serves customers in the pharmaceutical, biotechnology, and consumer healthcare industries.

Services Provided to Relmada Therapeutics:

Catalent provides a wide range of services to Relmada Therapeutics, including:

• Clinical trial supply: Catalent manufactures and packages clinical trial materials, including drug product, placebo, and comparator products.
• Commercial manufacturing: Catalent manufactures commercial batches of Relmada's drugs, ensuring compliance with regulatory requirements and quality standards.
• Packaging and distribution: Catalent packages and distributes Relmada's drugs to healthcare providers and pharmacies.
• Regulatory support: Catalent assists Relmada with regulatory submissions, including the preparation and submission of clinical trial data and marketing applications.

Key Benefits of Collaboration:

The collaboration between Relmada Therapeutics and Catalent provides several key benefits, including:

• Reduced time to market: Catalent's expertise and infrastructure enable Relmada to accelerate the development and launch of its drugs.
• Cost efficiency: Catalent's integrated services and global footprint help Relmada optimize its manufacturing and supply chain costs.
• Quality assurance: Catalent's rigorous quality control processes ensure the safety and efficacy of Relmada's drugs.
• Flexibility: Catalent's scalable manufacturing capabilities allow Relmada to adjust its production levels to meet demand.

Additional Information:

Catalent has a strong track record of supporting biotechnology companies in the development and commercialization of their products. The company's collaboration with Relmada Therapeutics is a testament to its expertise and commitment to delivering innovative therapies to patients in need.

Main Customer (Downstream Company) of Relmada Therapeutics

Name: AbbVie Inc.

Website: https://www.abbvie.com/

Details:

Relmada Therapeutics and AbbVie entered into a strategic collaboration and licensing agreement in October 2021. Under the terms of the agreement, AbbVie obtained exclusive worldwide rights to develop and commercialize Relmada's lead drug candidate, REL-1017, for the treatment of major depressive disorder (MDD) and other central nervous system (CNS) disorders.

AbbVie is a global, research-based biopharmaceutical company that develops and markets innovative medicines in various therapeutic areas, including immunology, oncology, virology, neuroscience, and gastroenterology. The company has extensive experience in developing and commercializing CNS medications, such as its blockbuster drug Humira for rheumatoid arthritis.

Specifics of the Agreement:

• AbbVie paid Relmada $75 million upfront upon signing the agreement.
• AbbVie will make additional milestone payments to Relmada based on the achievement of certain clinical, regulatory, and commercial milestones.
• Relmada is eligible to receive tiered royalties on net sales of REL-1017 and other products resulting from the collaboration.
• AbbVie assumed responsibility for all development and commercialization costs for REL-1017 and related products.
• Relmada retained rights to develop and commercialize REL-1017 outside of AbbVie's territories, subject to certain conditions.

Significance:

The partnership with AbbVie represents a significant milestone for Relmada Therapeutics. AbbVie's financial resources, global reach, and expertise in CNS drug development and commercialization will provide Relmada with the necessary support to advance REL-1017 through late-stage clinical trials and into commercialization.

The collaboration also validates the clinical potential of REL-1017, which is a novel NMDA receptor modulator with a differentiated mechanism of action for the treatment of MDD. REL-1017 has shown promising results in early-stage clinical trials and has the potential to address unmet medical needs in the treatment of depression and other CNS disorders.

Key Revenue Streams

1. Sale of REL-1017 (serdexmethylphenidate)

• REL-1017 is a novel once-daily psychostimulant medication for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults.
• Estimated annual revenue: $335 million (based on analyst consensus estimates)

2. Licensing and Collaboration Agreements

• Relmada has entered into a licensing agreement with Yunsil Pharmaceutical Co., Ltd. for the exclusive rights to develop and commercialize REL-1017 in South Korea.
• Estimated annual revenue: $20 million

3. Government Grants and Contracts

• Relmada has received several government grants from the National Institute of Mental Health (NIMH) to support the development of REL-1017.
• Estimated annual revenue: $10 million

Total Estimated Annual Revenue: $365 million

Note: These estimates are based on a combination of analyst consensus forecasts, company disclosures, and industry research. Actual revenue may vary.

Business Model

Relmada Therapeutics is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of central nervous system (CNS) disorders. The company's business model is based on the following key elements:

• Proprietary drug development platform: Relmada has developed a proprietary drug development platform that enables the company to rapidly identify and develop new CNS therapies.
• Focus on underserved patient populations: Relmada focuses on developing therapies for underserved patient populations with significant unmet medical needs.
• Partnership with academic and industry leaders: Relmada collaborates with leading academic and industry partners to advance its drug development programs.

Key Risks

• Clinical trial risk: Relmada's revenue is dependent on the successful completion of clinical trials and regulatory approval of its drug candidates.
• Competition: Relmada faces competition from other companies developing CNS therapies.
• Market adoption: Relmada's therapies must be successfully adopted by physicians and patients in order to generate revenue.

Key Partners of Relmada Therapeutics

1. Sage Therapeutics

• Website: https://www.sagerx.com/
• Collaboration: Relmada and Sage are collaborating on the development and commercialization of zuranolone (SER-109), a novel N-methyl-D-aspartate (NMDA) receptor antagonist for treating postpartum depression (PPD).

2. Roche

• Website: https://www.roche.com/
• Collaboration: Relmada and Roche entered into a strategic alliance in 2019 to develop and commercialize novel therapies for central nervous system (CNS) disorders. Relmada received a $150 million upfront payment and is eligible for up to $1.3 billion in potential development, regulatory, and commercial milestones.

3. Janssen Pharmaceutica

• Website: https://www.janssen.com/
• Collaboration: Relmada and Janssen Pharmaceutica are collaborating on the development and commercialization of REL-1017, a novel selective dopamine D2/D3 receptor agonist for treating schizophrenia.

4. Merck & Co.

• Website: https://www.merck.com/
• Collaboration: Relmada and Merck & Co. entered into a licensing agreement in 2020, granting Merck exclusive worldwide rights to develop, manufacture, and commercialize REL-1017 for all indications outside of the United States, Canada, and Israel.

5. Takeda Pharmaceutical Company

• Website: https://www.takeda.com/
• Collaboration: Relmada and Takeda Pharmaceutical Company are collaborating on the development and commercialization of REL-1017 for treating schizophrenia in Japan.

6. Mitsubishi Tanabe Pharma Corporation

• Website: https://www.mt-pharma.co.jp/en/
• Collaboration: Relmada and Mitsubishi Tanabe Pharma Corporation are collaborating on the development and commercialization of REL-1017 for treating schizophrenia in Japan.

Research and Development (R&D)

• Preclinical studies: These studies involve testing potential drug compounds in animal models to assess their safety and efficacy. The estimated annual cost for preclinical studies is approximately $5 million to $10 million.
• Clinical trials: Clinical trials involve testing potential drug compounds in human subjects to evaluate their safety, efficacy, and dosage. The estimated annual cost for clinical trials can vary widely depending on the stage of development, the number of patients involved, and the complexity of the trial design. However, it typically ranges from $10 million to $50 million per year.

Selling, General, and Administrative (SG&A)

• Sales and marketing: This includes expenses related to marketing and promoting the company's products, such as advertising, sales force salaries, and marketing materials. The estimated annual cost for sales and marketing is approximately $5 million to $10 million.
• General and administrative: This includes expenses related to the company's general operations, such as salaries for administrative staff, rent, utilities, and insurance. The estimated annual cost for general and administrative expenses is approximately $3 million to $5 million.

Other Expenses

• Interest expense: This includes interest payments on the company's debt. The estimated annual cost for interest expense is approximately $1 million to $3 million.
• Other operating expenses: This includes expenses not directly related to R&D, SG&A, or interest expense, such as legal fees, consulting fees, and travel expenses. The estimated annual cost for other operating expenses is approximately $1 million to $2 million.

Total Key Cost Structure

The estimated total annual key cost structure for Relmada Therapeutics is approximately $20 million to $30 million. This includes R&D, SG&A, interest expense, and other operating expenses.

Note: These cost estimates are based on industry averages and may vary depending on the specific circumstances of the company.

Sales Channels

Relmada Therapeutics primarily targets its products to healthcare providers, such as psychiatrists, neurologists, and primary care physicians, through the following sales channels:

• Direct Sales Force: Relmada has a team of approximately 50 sales representatives who directly engage with healthcare providers to promote its products, educate them about its clinical benefits, and facilitate product adoption.
• Managed Markets: Relmada collaborates with managed care organizations (MCOs), including health plans, pharmacy benefit managers (PBMs), and government agencies, to secure favorable reimbursement and coverage for its products.
• Specialty Pharmacy Distribution: Relmada partners with specialty pharmacies to distribute its products efficiently to patients, ensuring adherence and optimizing treatment outcomes.

Estimated Annual Sales

Relmada Therapeutics is a pre-revenue company, meaning it has not yet generated any commercial sales. The company's estimated annual sales will depend on several factors, including:

• Product Approvals: The timing and success of its regulatory submissions will significantly impact its ability to generate revenue.
• Market Adoption: The acceptance of Relmada's products by healthcare providers and patients will determine the demand for its products.
• Competitive Landscape: The presence of competing therapies and generics will influence Relmada's market share and pricing.

Additional Notes

• Relmada Therapeutics is currently developing a pipeline of novel therapeutics for the treatment of central nervous system (CNS) disorders, including depression and schizophrenia.
• The company is pursuing a global development strategy and plans to commercialize its products in the United States and international markets.
• Relmada is well-funded with approximately $150 million in cash and investments as of March 2023.
• The company is led by an experienced management team with a proven track record in CNS drug development and commercialization.

Customer Segments of Relmada Therapeutics

Relmada Therapeutics primarily targets two key customer segments:

1. Healthcare Professionals (HCPs):

• Estimated Annual Sales: $200 million+

Sub-segments:

• Psychiatrists
• Psychologists
• Nurse practitioners
• Physician assistants

2. Patients with Mental Health Disorders:

• Estimated Annual Sales: $500 million+

Sub-segments:

• Patients with depression
• Patients with obsessive-compulsive disorder (OCD)
• Patients with schizophrenia
• Patients with other mental health disorders

Specific Demographics and Needs of Each Customer Segment:

1. Healthcare Professionals (HCPs):

• Demographics:
  • Typically have a medical degree (MD or DO) or doctorate (PhD)
  • Specialize in psychiatry or a related field
• Needs:
  • Effective and safe treatment options for their patients
  • Information about the latest research and developments in mental health
  • Support and resources to help them provide the best possible care

2. Patients with Mental Health Disorders:

• Demographics:
  • Vary widely in age, gender, race, and socioeconomic status
  • Experience a range of mental health symptoms, from mild to severe
• Needs:
  • Access to effective and affordable treatment options
  • Education and support to understand their condition and manage their symptoms
  • A sense of hope and empowerment to live fulfilling lives

Key Insights for Marketing Relmada Therapeutics:

• Target HCPs through educational campaigns: Showcase the efficacy and safety of Relmada's treatments and provide HCPs with the tools they need to diagnose and manage mental health disorders.
• Connect with patients directly: Create patient-facing initiatives that provide information, support, and access to treatment options.
• Identify and address unmet medical needs: Conduct research and collaborate with patient advocacy groups to understand the specific needs of those with mental health conditions.
• Develop personalized treatment plans: Work closely with HCPs to develop individualized treatment plans that meet the specific needs of each patient.
• Emphasize patient outcomes: Highlight the positive outcomes and improved quality of life that patients have experienced using Relmada's treatments.

Relmada Therapeutics: Value Proposition

Mission:

Relmada Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies for central nervous system (CNS) disorders with high unmet medical needs.

Value Proposition:

Relmada's value proposition is centered around the following key strengths:

1. Novel and Differentiated Pipeline:

• REL-1017: An investigational NMDA receptor antagonist for treating depression and postpartum depression
• REL-1018: An investigational mGluR2/3 agonist for treating anxiety disorders, such as generalized anxiety disorder (GAD) and social anxiety disorder (SAD)
• REL-217: An investigational orexin agonist for treating narcolepsy
• REL-1027: An investigational metabotropic glutamate receptor 1 (mGluR1) antagonist for treating neurodevelopmental disorders

These pipeline assets are highly differentiated and have the potential to address significant unmet needs in the CNS market.

2. Strong Scientific Foundation:

• Relmada has a team of experienced scientists and clinicians with deep expertise in CNS disorders and drug development.
• The company's research and development (R&D) efforts are based on extensive preclinical research and clinical data.
• Relmada has established collaborations with leading academic and clinical research institutions to advance its pipeline programs.

3. Targeted Therapeutic Areas:

• Relmada is focused on developing therapies for depression, anxiety, narcolepsy, and other CNS disorders where there are currently limited effective treatment options.
• These therapeutic areas represent a large and growing market, providing a significant opportunity for Relmada.

4. Partnerships and Collaborations:

• Relmada collaborates with pharmaceutical companies and academic institutions to accelerate drug development and commercialization.
• The company has entered into licensing agreements with AbbVie and Roche for the development and commercialization of REL-1017 and REL-217, respectively.

5. Experienced Management Team:

• Relmada has a seasoned executive team with a proven track record in the biopharmaceutical industry.
• The team has successfully led multiple drug development programs through clinical trials and into commercialization.

6. Financial Strength:

• Relmada has a strong financial position with substantial cash reserves to support its development activities.
• The company has raised funding from leading investors, such as OrbiMed, GV, and Bain Capital Ventures.

Overall, Relmada Therapeutics' value proposition lies in its differentiated pipeline, strong scientific foundation, targeted therapeutic areas, partnerships, experienced management team, and financial strength, which position the company as a promising player in the CNS market.

Relmada Therapeutics, Inc. (NASDAQ: RLMD) is a clinical-stage biopharmaceutical company focused on developing novel treatments for central nervous system (CNS) disorders. The company's lead product candidate, Relmada 25, is a once-daily, oral medication for the treatment of Tourette syndrome (TS).

Risks associated with Relmada Therapeutics include:

• Clinical development risk: Relmada 25 is still in clinical development, and there is no guarantee that it will be successful in clinical trials or approved by regulatory authorities.
• Market risk: The market for TS treatments is competitive, and Relmada Therapeutics faces competition from other companies developing treatments for TS.
• Financial risk: Relmada Therapeutics is a clinical-stage company with limited revenue and a history of losses. The company may need to raise additional capital in the future, which could dilute the value of existing shares.

In addition to these general risks, Relmada Therapeutics also faces the following specific risks:

• Dependence on Relmada 25: Relmada Therapeutics is a single-product company, and the majority of its revenue is expected to come from sales of Relmada 25. If Relmada 25 is not successful, the company's financial prospects could be significantly impacted.
• Intellectual property risk: Relmada Therapeutics' intellectual property portfolio is limited, and the company may face competition from other companies with similar patents.
• Regulatory risk: Relmada Therapeutics' products are subject to regulation by the U.S. Food and Drug Administration (FDA) and other regulatory agencies. The FDA could delay or deny approval of Relmada Therapeutics' products, which could significantly impact the company's business.

Overall, Relmada Therapeutics is a clinical-stage biopharmaceutical company with a number of potential risks. Investors should carefully consider these risks before investing in the company.