Dar Bioscience Announces Positive Pharmacokinetic (PK) Results from the DARE-HRT1 Phase 1 / 2 Study that Support the Potential of DARE-HRT1 as an Effective Hormone Therapy for both Vasomotor and Vaginal Symptoms of Menop

Bioscience Announces Positive Pharmacokinetic (PK) Results from the DARE-HRT1 Phase 1 / 2 Study that Support the Potential of DARE-HRT1

as an Effective Hormone Therapy for both Vasomotor and Vaginal Symptoms of Menopause

Plans to Advance DARE-HRT1 into Single Phase 3 Efficacy Trial for Treatment of Vasomotor Symptoms (VMS) due to Menopause

has the potential to be the first FDA-approved monthly intravaginal ring delivering both estrogen and progestogen hormone therapy

DIEGO, January 9, 2023 (GLOBE NEWSWIRE) - Dar Bioscience, Inc. (NASDAQ: DARE), a leader in women's health innovation,

today announced topline PK results from its Phase 1 / 2 clinical trial of DARE-HRT1 that support the potential of DARE-HRT1 as an effective

hormone therapy (HT) based on the levels of hormones released. DARE-HRT1 is a novel, investigational intravaginal ring (IVR) designed

to deliver bio-identical 17 -estradiol and bio-identical progesterone continuously over a 28-day period as part of a HT regimen.

HT is used to treat the vasomotor symptoms (VMS) and genitourinary syndrome associated with menopause. DARE-HRT1 has the potential to

be the first FDA-approved product to offer vaginal delivery of combination bio-identical estradiol and bio-identical progesterone hormone

therapy in a convenient monthly format. Dar plans to advance DARE-HRT1 into a single Phase 3 clinical trial to support a new

drug application for DARE-HRT1 for the treatment of moderate to severe VMS due to menopause in women with intact uteri.

delivery of hormone therapy over a 12-week study via a 28-day intravaginal ring which requires no daily intervention supports DARE-HRT1's

potential to be a first-in-category option, offering ease-of-use and consistent dosing to women suffering from menopausal symptoms. There

are currently no FDA-approved products that continuously deliver hormone therapy with both estradiol and progesterone together over multiple

consecutive weeks," said Dr. Annie Thurman, Medical Director of Dar Bioscience. "We believe these Phase 1 / 2 topline

data support progressing directly into a single Phase 3 study following the Investigational New Drug (IND) submission to and clearance

reported topline efficacy data from the Phase 1 / 2 study demonstrated improvement in both VMS as well as vaginal symptoms of menopause.

The North American Menopause Society's (NAMS) guidance on hormone therapy states that dosing estrogen and progestogen in combination

may offer important benefits to women, and NAMS observed that non-oral routes of administration may offer advantages over orally administered

IVR technology used in DARE-HRT1 was developed by Dr. Robert Langer from the Massachusetts Institute of Technology and Dr. William Crowley

from Massachusetts General Hospital and Harvard Medical School. Unlike other IVR technologies, Dar 's IVR drug delivery

technology is designed to release more than one active ingredient via a solid ethylene vinyl acetate polymer matrix without the need

for a membrane or reservoir to contain the active drug or to control the release, allowing for sustained drug delivery.

from a prior randomized, open-label, three-arm, parallel group Phase 1 study that evaluated the PK of DARE-HRT1 in approximately 30 healthy,

post-menopausal women with intact uteri demonstrated that DARE-HRT1 successfully delivered both estradiol and progesterone over the 28-day

evaluation period. The estradiol PK data in that prior DARE-HRT1 Phase 1 study support the potential of DARE-HRT1 as an effective hormone

therapy for both VMS and vaginal symptoms associated with menopause.

Phase 1 / 2 Clinical Trial Study Design

randomized, open-label, two-arm, parallel group Phase 1/2 study was designed to evaluate DARE-HRT1's safety, PK, and preliminary

efficacy in improving the VMS as well as the vaginal symptoms of menopause in approximately 20 healthy, post-menopausal women (age range

51-65 years, mean 59 years) with intact uteri over approximately three consecutive months of use. The primary objective of the study

was to describe the safety, tolerability, and PK of two different dose combinations (estradiol 80 g/progesterone 4 mg IVR and

estradiol 160 g/progesterone 8 mg IVR) over 12 weeks of use. Secondary objectives of the study were to assess the usability, participant

tolerability, and preliminary effectiveness of DARE-HRT1 for both the VMS and vaginal symptoms of menopause.

study was conducted by Dar 's wholly owned subsidiary in Australia.

Results of the Phase 1 / 2 Clinical Trial

data from the study demonstrate that DARE-HRT1 successfully delivered estradiol and progesterone over the 12-week evaluation period.

The baseline-corrected steady state release of estradiol and progesterone from both the lower (IVR1) and higher (IVR2) dose versions

of DARE-HRT1 evaluated in the study demonstrated steady state release levels in month 3 of the 12-week study as shown in the table below:

levels of estradiol released from both the lower and higher dose formulation of DARE-HRT1 evaluated in the study achieved or exceeded

the levels that were targeted for hormone therapy. Target levels of estradiol for hormone treatment for either the VMS or vaginal symptoms

of menopause were established by reviewing PK levels published for FDA-approved products for both the treatment of VMS as well as the

genitourinary symptoms of menopause. Based on the estradiol PK data in the DARE-HRT1 Phase 1 / 2 study, the results support the potential

of DARE-HRT1 as an effective hormone therapy for both VMS and vaginal symptoms associated with menopause. The levels of progesterone

released from both versions of DARE-HRT1 evaluated in the study met the objectives of releasing progesterone. Progesterone is used in

hormone therapy to reduce the impact of estrogen on nontarget sites, such as the endometrium, to prevent estrogen-induced endometrial

levels of estradiol released from both the lower and higher dose formulation of DARE-HRT1 evaluated in the study achieved statistically

significant improvement in VMS as well as the genitourinary symptoms of menopause, and vaginal pH and maturation index.

symptoms, including hot flashes and night sweats, were reduced compared with baseline in both DARE-HRT1 dose groups (p<0.01). Participants

also showed significant improvement from baseline in all measures surveyed on The Menopausal Quality of Life Survey (MENQOL), which surveys

not only parameters of VMS, but also physical, psychosocial and sexual symptoms (p<0.01 on all domains). With DARE-HRT1 use, vaginal

pH significantly decreased compared to baseline (p<0.01) and cytologic tests of the vaginal epithelium (vaginal maturation index)

showed significant normalization (all p values <0.01 for increases in superficial cells, increases in intermediate cells and decreases

in parabasal cells from baseline) among all participants. Finally, the most common genitourinary symptom, vaginal dryness, which was

reported by 70% of participants at baseline, showed significant improvement in both DARE-HRT1 groups (p<0.01) and this subset also

experienced significant decreases in vaginal pain with DARE-HRT1 use (p<0.01).

study treatment was well tolerated with the types of most common adverse events consistent with other vaginal products. There were only

two early discontinuations due to an adverse event, and no serious adverse events were reported.

had a high level of acceptability in the study, with 100% of subjects reporting that the IVR was comfortable to wear, and there were

no reports of the IVR being expelled from the vagina during use. Additionally, over 95% of subjects stated they would be either somewhat

or very likely to use the IVR for a women's health condition or unrelated disease if needed.

plans to submit data from the Phase 1 / 2 clinical study of DARE-HRT1 for publication in a peer-reviewed publication.

505(b)(2) Regulatory Pathway

clinical development, Dar intends to leverage the existing safety and efficacy data on the active ingredients in DARE-HRT1, estradiol

and progesterone, to utilize the U.S. Food and Drug Administration's (FDA) 505(b)(2) pathway to obtain marketing approval of DARE-HRT1

intends to seek FDA approval of DARE-HRT1 for the treatment of moderate to severe VMS due to menopause in women with intact uteri. Based

on pre-IND communications with the FDA and the topline PK data from the DARE-HRT1 Phase 1 / 2 study, Dar believes FDA approval

of DARE-HRT1 for that indication is achievable via the 505(b)(2) pathway supported by a single, placebo-controlled, Phase 3 clinical

trial of DARE-HRT1 and a scientifically justified PK "bridge" (via a relative bioavailability trial) between DARE-HRT1 and

the selected listed estradiol and progesterone drugs. Ongoing activities to support progressing directly into a single Phase 3 study

to support registration include manufacturing and non-clinical studies to support the IND submission and the planned IND-opening Phase

is defined as the final menstrual period and is typically confirmed after a woman has missed her period for 12 consecutive months. Most

women experience menopause between ages 40 and 58.1 An estimated 45 million women in the U.S. are approaching or in menopause,

which results in a decrease in estrogen and other hormones.1,2 Hot flashes, vaginal dryness and loss of bone density are frequently

associated with menopause. Night sweats (hot flashes that occur during sleep) often cause sleep disturbance, and vaginal atrophy (the

drying and thinning of vaginal tissues) can cause a feeling of vaginal tightness during sex along with pain, burning, or soreness.1

Hence, management of menopausal symptoms can impact quality of life, productivity and health. The North American Menopause Society

(NAMS) believes that hormone therapy is the most effective treatment for VMS and the genitourinary syndrome of menopause and observes

that a non-oral route may offer advantages over oral routes of administration.2

Menopause 101: A primer for the perimenopausal. NAMS, accessed 6 January 2023.

symptoms-and-treatments/menopause-101-a-primer-for-the-perimenopausal.

NAMS Position Statement. The 2022 hormone therapy position statement of The North American Menopause Society. Menopause: The Journal

of The North American Menopause Society Vol. 29, No. 7, pp. 767-794 DOI: 10.1097/GME.0000000000002028. https://www.menopause.org/docs/default-

source/professional/nams-2022-hormone-therapy-position-statement.pdf

Bioscience is a biopharmaceutical company committed to advancing innovative products for women's health. The company's mission

is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women's health and

well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, fertility, and vaginal and sexual

first FDA-approved product, XACIATO (clindamycin phosphate) vaginal gel, 2% is a lincosamide antibacterial indicated for the treatment

of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. XACIATO

is a clear, colorless, viscous gel, to be administered once intravaginally as a single dose. Dar 's portfolio also includes

potential first-in-category candidates in clinical development: Ovaprene , a novel, hormone-free monthly intravaginal contraceptive

whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil

to treat female sexual arousal disorder utilizing the active ingredient in Viagra ; and DARE-HRT1, a combination bio-identical estradiol

and progesterone intravaginal ring for hormone therapy following menopause. To learn more about XACIATO, Dar 's full portfolio

of women's health product candidates, and Dar 's mission to deliver differentiated therapies for women, please visit

www.darebioscience.com.

may announce material information about its finances, product and product candidates, clinical trials and other matters using the Investors