Pre-IPO women's health pharmaceutical company: Arstat overview

1. Arkady Rubin, PhD
Chief Scientific Officer and Acting CEO
May 23, 2023
1
Introducing Phase III-Ready NUVOCEPTTM
The first and only contraceptive endorsed by the FDA for exclusive
testing and labeling in overweight and obese women
Developed by a co-inventor of the best-selling US contraceptive pill
ARSTAT Pharmaceuticals
Pre-IPO Investment and Partnership Opportunity

2. For the First Time, Addressing a High Public Health Priority
2
* The rates are for reproductive-age US women. Body Mass Index (BMI) categories: - Obese - BMI ≥ 30 kg/m2; Overweight - BMI 25 - 29.9 kg/m2.
The overruling of Roe disproportionally impacts women with high BMI
20 million of overweight and obese US women search for reliable birth control
— with common choices (hormonal pills, patches, and rings) performing poorly in this population
Safe and Effective Hormonal Contraception for Women with High BMI
It is exceptional, if not historic, timing to offer the most popular contraceptive
method – the pill – as a trusted option for a growing majority of US women.
Obese women have up to 4.3 times greater
chance of an unintended pregnancy**
Obese women have up to 3.7 times
greater odds of terminating a pregnancy**
≈ 40% of US women are obese** ≈ 25% are overweight*
** Doskoch P. Obesity linked to elevated risk of unintended pregnancy, abortion, STDs. Perspectives on Sexual and Reproductive Health. 2010;42:276.

3. Team (Management/Advisors)
3
120+ years of working with leading women’s health brands
Andrea S. Lukes, MD, FACOG
Lead Clinical Advisor
Dr. Lukes has conducted >80 of women’s
health trials, authored multiple publications.
Barbara Levy, MD, FACOG. FACS
Medical Affairs Advisor
Women's health advocate, a previous
ACOG’s Vice President for health policy.
Agis Kydonieus, PhD
Drug Delivery Advisor
A founder of the Controlled Release Society,
the author of 10 books on drug delivery
Kate McKinley, MBA
Strategic Leadership Advisor
A former CEO of a successful oncology
company, member of several BoDs.
Russell Barrans, MBA
Commercial Strategy Advisor
A commercial expert who has introduced
widely known contraceptive brands.
Wendy J. Weiser
Chief Operating Officer
A founder of one of the largest medical
association management firms with a
COO experience in a women's health company
Management
Clinical and Commercial Advisors
Jason Spitz, MBA
VP, Marketing & Corporate Communications
Executive who was responsible for commercial
operations, marketing and corporate communications
in a public women's health company
Arkady Rubin, PhD
Founder, Chief Scientific Officer, Acting CEO
An industry veteran (J&J, Pfizer) who designed pivotal studies of top contraceptive brands
and majorly contributed to their approval. A co-inventor* of Ortho Tri-Cyclen Lo®, one of the best
US pills ($500M in 2015). Its 9% prescription share is translated into $1.8B/year in today’s market.
*Patents: EP1140109, AU765153, CA2356747, and many others

4. NUVOCEPTTM - A Truly Powerful Asset
4
The first and only contraceptive endorsed by the FDA for the
exclusive clinical testing and labeling in women with high BMI
It will likely dominate a multi-billion-
dollar segment of the US market
Projected Sales >$2B/year
1
2
Validated by the FDA acceptance
of safety and efficacy projections
Low-Risk
Successful meeting with the FDA;
an abbreviated program is finalized
Phase III-Ready
< $20M in total costs and <3.5
years to the FDA approval
Rapid, Low-Cost R&D
4
5
NUVOCEPTTM
6 Strong IP Portfolio
Six US patents and an EU patent
covering major European markets
Unprecedented Label
3
New indication and unique claims for
a lasting competitive advantage

5. Problem:
Marketed Contraceptives are Not Intended for Obese Women
5
Most Phase III trials excluded women with high BMI, and many
approved contraceptives are marketed to an unstudied population
Excluding from
pivotal trials
Due to poor drug absorption, obese women receive 70-80% of the
nominal dose1,2,3,4,5 with unsatisfactory pregnancy prevention
Delivering
suboptimal doses
Modern contraceptives cannot be recommended to obese women
due to a troubling incidence of serious cardiovascular events6,7,8
Increasing
cardiovascular risks
Selected Sources: 1Edelman (2009), 2Edelman (2014), 3Westhoff (2010), 4Evra (2001), 5Robinson (2013), 6ARSTAT Inc. (Data on file), 7Abdollahi (2003),
8FDA (2011), 9Yamazaki (2015), 10NDA 204061 (2013), 11Annovera (2018), 12Twirla (2020), 13Nextstellis (2021)
NONE of the combined hormonal contraceptives approved in the past 12
years are suitable for obese women due to poor efficacy and safety,
labeled contraindications, and limitations of use 9,10,11,12,13

6. Problem:
Contraceptive Failures are Particularly Troubling
1Holt (2002), 2Holt (2005), 3CDER, 3NDA 204061 (2013), 4Brunner LR (2005), 5Brunner (2006),6Dinger
(2011), 7Burkman (2009), 8Weisberg (2012), 9Yamazaki (2015), 10FDA (2019), 11Moskosky (2016)
• Holt1: Risk of pregnancy increases by 60% for overweight and obese women
• Holt2: Risk of pregnancy increases by 58% and 72% for overweight and obese women.
Among consistent users (no missing pills), the risk is doubled
• Quartette®3: Risk of pregnancy increases by 31% and 86% for overweight and obese women.
• Brunner4: Risk of pregnancy increases by 80% for obese women
• Brunner5: 2.5 & 2.8 times more pregnancies for overweight and obese women
• Dinger6: Significant increase in contraceptive failures with higher BMI
• Burkman7: 1.8 times higher pregnancy rates for overweight and obese women
• Weisberg8: Risk of pregnancy increases by 55% for obese women
• Yamazaki9: 8.8 times more pregnancies for obese women (marketed patch)
• Twirla®10: 1.6 & 2.5 times more pregnancies for overweight and obese women
6
The overruling of Roe v. Wade makes the need for
effective birth control more urgent than ever

7. Problem:
Recognized by the FDA as a Large Unmet Medical Need
7
Seminal FDA Paper: Meta-analysis of the impact of obesity on
contraceptive efficacy
Further confirmed at the FDA Advisory Committee Meeting (October 30, 2019)
— NDA 204017, AG200-15 transdermal system (Twirla®)
 Based on data from multiple Phase III studies of approved contraceptives
 Pregnancy rates increase by 65% for obese vs. non-obese women

8. Our Solution: FDA-Endorsed NUVOCEPTTM
8
“Women will LOVE it”
(Andrea S. Lukes,
MD, MHSc FACOG)
Dr. Lukes conducted >80 trials of
women’s health products.
Hormonal
components tested
by millions of women
Up to 3 times lower
pregnancy rates vs.
leading brands
2 – 3-fold reduced risk
of serious side effects
vs. modern pills
The FDA has recognized the importance of
NUVOCEPT and allowed its move to Phase III
 NUVOCEPT efficacy and safety projections accepted
— no need for Phase I or Phase II data*
— the FDA has approved the immediate dosing of 1,500+ women
 After the pre-IND meeting, a new FDA guidance was Issued
— the impact of obesity on contraceptive efficacy is emphasized
*At least seven other approved oral contraceptives also started clinical testing in Phase III
 NUVOCEPT’s unique label is conceptually endorsed
Highly
Effective
Very
Safe
Gold Standard in
Oral Contraception
Novel oral contraceptive uniquely formulated for women with high BMI

9. Issued and new US patents and regulatory
exclusivity are expected to protect NUVOCEPT
until at least 2037, possibly much longer
9
US Patents: 9,675,622; 9,925,199; 10,111,887; 10,463,678;
10,537,582; 11,103,515 3 more US patents planned
European (EU) Patent: EP 2790688 B1.
NUVOCEPTTM: Additional Details
Intellectual Property
A Wealth of Clinical Data Supports Target Product Profile
High user satisfaction
and treatment compliance
Efficacy comparable to
normal-weight pill users
Cardiovascular risks similar
to the best safety standard
 The specifics of the program, including a Phase III study design, are confirmed by the FDA
 Straightforward, inexpensive manufacturing of clinical supplies
 Detailed study cost and time estimates are received from a leading women’s health CRO
 A database of top-quality contraceptive research sites is being assembled
Poised To Start Phase III

10. 10
NUVOCEPTTM Unique Label: a Pillar of Commercial Success
Appealing efficacy and safety features supported
by a unique database of women with high BMI
1 The most attractive (if not the only) option for
women with high BMI due to a dedicated label
The safest solution when overweight women desire
the pill for non-contraceptive reasons (>30% of users)
2
3
Take a risk with
inferior or untested
contraceptives
OR
prescribe NUVOCEPT
Expected Labeling Benefits for Lasting Competitive Advantage
Unique indication: “Prevention of pregnancy for overweight and obese women”
Unlike all recently approved brands, no contraindications or limitations of use
Reduced risks of pregnancy and VTE (Phase III data and historical comparisons*)
*To be confirmed after the NDA filing

11. NUVOCEPTTM: Expected to Dominate >30% of the US Market
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According to top experts, US gross sales may exceed $2B/year
 Very large commercial opportunity for ≈ 20 million overweight or obese US women
seeking contraception, including ≈6 million current pill users
 At a branded wholesale (WAC) price, the gross value of the US combined hormonal
contraceptive market would be approximately $20B ($200M for each % of total Rx)
 With the only label dedicated to obese women (at least 30% of contraceptive pill users),
NUVOCEPT is expected to dominate a potential $6B market segment
 With overweight women (≈30% of users) excluded, this assessment is very conservative
Favorable Market Access & Coverage
 Will likely be accepted as the 1st line oral contraceptive for women with high BMI
 A recent US Government Guidance (2022) mandates to cover all FDA-approved
contraceptives, irrespective of the availability of generics or similar brands. It is a highly
beneficial development that further enhances Nuvocept commercial potential.

12. Other ARSTAT Assets: Highlights
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SPRM = Selective Progesterone Receptor Modulator;
** NSAID = Nonsteroidal anti-inflammatory drug
PREMRINGTM ENHANTATM
DUACEPTTM
• First-in-category vaginal ring for
uterine fibroids & endometriosis
(14 million US women)
• Greater efficacy: Targeted delivery
of an SPRM for strong therapeutic
action at a fraction of the oral dose
• Better safety: Unlike other hormonal
therapies, no severe menopausal
symptoms (hot flashes, bone loss)
• Efficacy testing starts with Phase IIb
• Two granted US patents
• Potential US blockbuster
• First-in-category non-hormonal
therapy for painful, heavy menstrual
periods (>25 million US women).
• Novel drug combination: an
NSAID** and an antifibrinolytic
combined in the safest and most
effective way
• Phase IIb-ready; could be a Phase III
asset (FDA confirmation needed)
• $17M & 4 years to the US market
• Three granted US patents
• Likely first-line for a highly prevalent
disorder; no meaningful competition
• An improved version of the world-
leading oral contraceptive for 2
million normal-weight US pill users
• Phase III-ready: it may be developed
in parallel with NUVOCEPT for ≈$5M
and submitted under the same NDA;
< 3.5 years to the US market
• In some countries, it may be
approved with no new clinical data
• A US patent and an EU patent
Developing One of the Best Pipelines in Women’s Health

13. Business Strategy: Roadmap and Exit Opportunities
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The IPO ($45M)
R&D Completed
Products Sold
Near-Term Exit:
(4-5x ROI)
Exit
(25-30x ROI)
$5M Series A
Immediately
̴ 6-12 months
3 – 3.5 years
̴ 3 years

14. Going Public via an IPO: Strategic Considerations
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* www.mtspartners.com/wp-content/uploads/sites/2/2016/08/Early-Stage-IPOs-2012-2018-August-2018.pdf
4
5 A notable precedent
— a women’s health pharma company (Myovant Sciences) had the largest
biotech IPO of 2016 five months after its launch with a few employees**
— with a pipeline less advanced and arguably comparable to ARSTAT’s
— recently (10/2022), sold to Sumitovant Biopharma at a total value of $2.9B
1 Investment bankers consider ARSTAT a potentially great public company
— rapid, low-risk, low-cost R&D, huge markets, clear and achievable strategic goals
2 Impeccable market timing
— the overruling of Roe v. Wade makes NUVOCEPT a precious opportunity for IPO investors
3
An early exit option to investors of the current funding round
More advanced pipeline vs. two-thirds of biopharma IPOs*
— high IPO valuations for companies with a lead asset in Phase III*
** https://medcitynews.com/2016/10/myovant-sciences-rallies-218-million-biotech-ipo/

15. The Ask and Pre-IPO Action Plan
15
ARSTAT is raising $5M to continue R&D and support a $45-million IPO
(11-12 months after completing this round)
Major Tasks
 Finalize executive team and assemble a well-connected board of directors
 Conduct two more pre-IND meetings with the FDA (PREMRING and ENHANTA)
 Open two INDs (NUVOCEPT/DUACEPT and ENHANTA) and be ready for two pivotal studies
 Support IPO-related activities (legal, accounting, regulatory filings, marketing)
 Series A preferred shares  $20M pre-money valuation
G&A and R&D Expenses
$2,200.000
Corporate Development
$450,000
Direct IPO Costs*
$1,350,000
Contigency Reserve
$1,000,000
44%
9%
27%
20%
$5,000,000
Use of Funds
A key component of our
risk mitigation strategy
* Excludes Underwriters' fees and expenses paid at closing

16. A Fast-Track IPO and Other Options
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If market conditions are not favorable for a comprehensive public offering (slide 14),
investment bankers recommend a fast-track IPO with an initial focus on NUVOCEPT:
 The IPO size will be reduced to $20-25M (additional funding will be secured later)
 Pre-IPO R&D activities will be limited to the opening of the NUVOCEPT IND
 ARSTAT’s immediate (pre-IPO) funding needs will be reduced to $2 -$2.5M
 The time to the IPO will be shortened to 6-7 months
While the IPO is strongly preferred, ARSTAT may consider a direct listing or a
reverse merger with a public company. To be discussed with investors and partners
Contact: Arkady Rubin, PhD
Chief Scientific Officer and Acting CEO
+1 347-385-0878 arubin@arstatinc.com www.arstatinfo.com