NUVOCEPT - Addressing a major unmet contraceptive need    

• Marketed oral contraceptives do not work well for overweight and obese women due to an increased risk of pregnancy and serious side effects. With obesity rates and unintended pregnancies at epidemic levels, reliable oral contraception for overweight women is a major unmet medical need.

• Unlike any other oral contraceptive, Nuvocept is formulated to address these efficacy and safety concerns:
  — Up to 3 times lower pregnancy rates vs. leading brands
  — 2 - 3-fold reduced risk of serious side effects vs. modern pills

• The FDA-endorsed clinical program with an unprecedented focus on overweight and obese women                 — A favorable pre-IND meeting has finalized a pathway to the unique Nuvocept label

• A low-risk Phase III asset: <$20M in total R&D costs; 3.5 years to the US market

• Peak annual US-only sales will likely exceed $700M.

    Another patented contraceptive brand - DUACEPT

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• Patented, clinically beneficial mix of two popular pills –an improved version of the best-selling EU brand

• Strong product for normal-weight women that may be developed in parallel with Nuvocept for ~ $5M 

• Nuvocept and Duacept target different populations and are not competing against each other

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PREMRING - A better option for uterine fibroids and endometriosis

• Optimal use of the most promising drug: ultra-low doses of a specific, well-studied Selective Progesterone Receptor Modulator (SPRM) are delivered by a novel route, directly to affected tissues:
  — Greater Efficacy: High local drug concentrations result in strong and fast therapeutic action at a small fraction of oral dose – superior to other therapies.
  — Limited Side Effects: Unlike other hormonal therapies (e.g., Lupron Depot®), Premring will NOT be associated with severe menopausal symptoms, such as hot flashes and bone loss.
  — Safe Long-Term Therapy: Improved safety permits long-term treatment (not an option for other hormonal medications), greatly reducing the need for gynecological hospitalizations and radical surgeries.

• Premring may alter the way the targeted conditions are treated and generate >$1B/year (US-only)

ENHANTA - New way to treat painful and heavy menstrual periods

• Enhanta is a novel, proprietary oral drug combination of an NSAID and a low-dose antifibrinolytic (tranexamic acid) that combines two popular medications in the safest and most efficacious way. 

• Two valuable formulations: (1) prescription-strength (Rx) - for women clinically diagnosed with dysmenorrhea and/or menorrhagia; (2) over-the-counter (OTC)  - for women perceiving their menstrual periods as painful and heavy (no diagnosis).

• < $17M in projected R&D costs; < 4 years to the US market. Very high probability of successful development.

• A likely first-line therapy for a highly prevalent, undertreated disorder. Peak US sales may exceed $500M/year. 

Our Innovation & Intellectual Property ( 10 Granted US Patents)

• A multiphasic oral contraceptive with progressively increasing hormone doses and a constant progestin-to-estrogen ratio has never been considered. A gradual increase in dose greatly improves efficacy and menstrual cycle control, while a constant ratio reduces unwanted hormonal side effects

• Nuvocept and Duacept are protected by six US patents: Patent 9,675,622; Patent 9,925,199; Patent 10,111,887; Patent 10,463,678, Patent 10,537,582, and Patent 11,103,515 (all patents expire in 2031, extendable to 2033).
  — Nuvocept and Duacept are also protected by a European (EPO) Patent: EP 2790688 B1.

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• Targeted, controlled delivery of SPRM was never applied to the treatment of uterine fibroids and endometriosis. Premring is a novel, proprietary vaginal ring with no similar predecessors:
  — Protected by US patent 10,251,836 and US Patent 11,116,718 (expire in 2031, extendable to at least 2034),
  — Two pending US patents; two issued German patents; 6-8 continuation patents planned (US, ex-US)

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• An NSAID was never combined with a low-dose tranexamic acid for the management of painful and heavy menstrual periods.  Enhanta is a novel drug formulation designed to treat a highly prevalent disorder,                    — Protected by US Patent 10,251,836 and US Patent 10,709,679 (expire in 2031, extendable to at least 2034).            — Another US patent is pending; an issued German patent; 2-3 continuation patents planned (US, ex-US)

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• All patents are developed by Arkady Rubin, PhD, a co-inventor of Ortho Tri-Cyclen Lo® - the best-selling oral contraceptive in the US over the past decade.

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An opportunity overview: 

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To learn more, please open an abridged presentation:          

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Contact Us 

We’re always happy to hear from you.

Do contact us to learn more 

Arkady Rubin, Ph.D.

arubin@arstatinc.com

(347)385-0878