Dare Bioscience Investor Presentation Deck
NIH
DARE-FRT1 and DARE-PTB1*
Bio-identical progesterone 14-day IVR for prevention of preterm birth and luteal phase support as part of an IVF treatment plan.
There are currently no FDA approved products marketed in the U.S. that do not require daily dosing of progesterone.
Prevention of Preterm Birth (PTB)
After steadily declining from 2007 to 2014², the US premature birth rate rose for the fourth straight
year in 2018 with -10% of babies born preterm (<37 weeks).3
NIH Grant Funding for PTB Program
Potential for up to $2.3 million in NIH grant funding to support DARE-PTB1 development
•Notice of award for initial $300,000 in grant funding announced Aug 2020. Eunice Kennedy Shriver
National Institute of Child Health & Human Development of the National Institutes of Health Award
Number R44 HD101169.
Assisted Reproductive Technologies (ART)/IVF
As women wait longer to have children, infertility risk increases
•~12-15% of couples cannot conceive after 1-year of unprotected sex.4
•~20% of US women have their first child after age 35; -1/3 of couples in which the woman is older
than 35 years have fertility problems.5
*505(b)(2) candidate¹
1.Anticipated regulatory pathway. Daré has not had any communications with the FDA regarding the specific marketing approval requirements for DARE-FRT1 or DARE-PTB1
2.2019 March of Dimes Report Card, https://www.marchofdimes.org/mission/reportcard.aspx
3.CDC's National Center for Health Statistics, National Vital Statistics Reports, Births: Final Data for 2018, Nov 27, 2019, https://www.cdc.gov/nchs/data/nvsr/nvsr68/nvsr68_13-508.pdf
4.https://www.nichd.nih.gov/health/topics/infertility/conditioninfo/common accessed January 8, 2021
5.https://www.cdc.gov/reproductive health/infertility/index.htm accessed January 8, 2021
6. Harris Williams & Co. Fertility market overview. May 2015.
Current products for delivery of
progesterone for prevention of preterm
birth, as well as luteal phase support in
ART, are limited to daily vaginal or
intramuscular injectable dosage forms,
which have limitations in patient comfort,
convenience, and outcomes.
The IVR is designed to deliver bio-
identical progesterone continuously over
a 14-day period and is being developed as
a more convenient treatment option for
the prevention of preterm birth (DARE-
PTB1) and broader luteal phase support
as part of an in vitro fertilization regimen
(DARE-FRT1).
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