GlobeNewswire Inc | May 13, 2021 08:00AM EDT

May 13, 2021

SAN DIEGO, May 13, 2021 (GLOBE NEWSWIRE) -- DarBioscience, Inc. (NASDAQ: DARE), a leader in womens health innovation, today reported financial results for the quarter ended March 31, 2021 and provided a company update.

The strong momentum of 2020 continued during the first quarter of 2021 for Dar. Having completed the DARE-BVFREE Phase 3 study in late 2020, we are preparing to file a New Drug Application with the FDA for DARE-BV1 for the treatment of bacterial vaginosis during the second quarter. This will be Dars first NDA submission and represents a meaningful milestone for our company, said Sabrina Martucci Johnson, President and CEO of Dar Bioscience. In March of 2021, we initiated the Phase 2b RESPOND study of Sildenafil Cream, 3.6% for the treatment of female sexual arousal disorder, and our clinical sites are actively recruiting. FSAD represents a significant unmet need, with an estimated 10 million women in the U.S. experiencing distress from symptoms of low or no sexual arousal and actively seeking treatment. Dars strategy is to identify and advance candidates that address persistent unmet needs in womens health, and Sildenafil Cream, 3.6% falls squarely within our mission.

2021 Key Portfolio Objectives

-- DARE-BV1: NDA submission and strategic commercialization agreement. -- Sildenafil Cream, 3.6%: Phase 2b clinical study topline data. -- Ovaprene: Investigational Device Exemption (IDE) submission. -- DARE-HRT1: Phase 1 clinical study topline data. -- DARE-VVA1: Initiation of Phase 1 clinical study.

Portfolio Accomplishments and Management Expectations for 2021-2022

-- DARE-BV1: Dar innovation: Novel, investigational thermosetting bioadhesive hydrogel formulated with clindamycin phosphate 2% as a first-line, single-administration treatment for bacterial vaginosis.4Q 2020: Successful completion of the DARE-BVFREE Phase 3 clinical study.2Q 2021: Submit NDA to the U.S. Food and Drug Administration (FDA).2021 PDUFA goal date: Fast track and Qualified Infectious Disease Product (QIDP) designations allow for a priority review request at the time of NDA submission, which, if granted, could lead to FDA approval in the current year.2021: Execute and announce commercialization strategy for DARE-BV1 in the U.S. to support a robust market introduction in 2022, if approved.

-- Sildenafil Cream, 3.6%: Dar innovation: Proprietary, investigational cream formulation of sildenafil, the active ingredient in Viagra, for topical administration to treat female sexual arousal disorder (FSAD).1Q 2021: Commenced Phase 2b RESPOND clinical study.Year-end 2021: Topline data readout of RESPOND clinical study targeted for 4Q.No FDA-approved products exist today to treat FSAD.FSAD is a physiological condition characterized by the inability to attain or maintain sufficient genital arousal during sexual activity and, of the various types of female sexual dysfunction disorders, is most analogous to erectile dysfunction in men.

-- DARE-HRT1:Dar innovation: Unique, investigational 28-day intravaginal ring (IVR) containing bio-identical estradiol and bio-identical progesterone for the treatment of vasomotor symptoms and genitourinary syndrome associated with menopause.2Q 2021: Topline data readout of Phase 1 clinical study targeted for 2Q. -- Ovaprene:Dar innovation: Novel, investigational hormone-free monthly intravaginal contraceptive whoseU.S.commercial rights are under a license agreement with Bayer.4Q 2021: Submit IDE to the FDA for a pivotal contraceptive clinical study in the U.S.1Q 2022: Commence pivotal Phase 3 clinical study.Year-end 2022: 6-month safety and efficacy data readout targeted for 4Q 2022. -- DARE-VVA1:Dar innovation: Proprietary, investigational formulation of tamoxifen for vaginal administration to treat vulvar and vaginal atrophy (VVA) in women with or at risk for hormone-receptor positive breast cancer.2H 2021: Initiate Phase 1 clinical study to be conducted in Australia.

Financial Highlights for Quarter ended March 31, 2021

-- Cash and cash equivalents: $7.7 million at March 31, 2021, compared to $4.7 million at December 31, 2020. -- Net cash from financing activities during 1Q 2021 was approximately $11.4 million and included net proceeds from sales of common stock under the companys at-the-market offering program and equity line and warrant exercises. -- General and administrative expenses were approximately $1.94 million in 1Q 2021, as compared with $1.86 million in 1Q 2020, with the increase reflecting higher personnel costs and stock-based compensation expense. -- Research and development expenses were approximately $5.7 million in 1Q 2021, as compared to approximately $2.4 million in 1Q 2020. The $3.3 million increase was due primarily to increases in expenses related to clinical trial and other development and regulatory affairs activities for Sildenafil Cream, 3.6%, DARE-BV1, Ovaprene and DARE-HRT1. -- Comprehensive loss for 1Q 2021 was approximately $7.3 million, as compared to approximately $4.3 million for 1Q 2020.

Recent Financial Developments

-- Between April 1, 2021 and May 10, 2021, Dar received additional cash of approximately $2.6 million (net of fees) from sales of common stock under the companys at-the-market offering program and equity line. -- As of May 10, 2021, approximately 49.4 million shares of Dar common stock were outstanding.

Conference Call

Dar will host a conference call and live webcast today at4:30 p.m. Eastern Timeto review the company's financial results for the quarter ended March 31, 2021 and to provide a company update.

To access the conference call via phone, dial (844) 831-3031 (U.S.) or (443) 637-1284 (international). The conference ID number for the call is 7857813. The live webcast can be accessed under Presentations, Events & Webcasts" in the Investors section of the company's website at http://ir.darebioscience.com. Please log in approximately 5-10 minutes prior to the call to register and to download and install any necessary software. To access the replay, please call (855) 859-2056 (U.S.) or (404) 537-3406 (international). The conference ID number for the replay is 7857813. The call and webcast replay will be available untilMay 27, 2021.

About Dar Bioscience

Dar Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for womens health. The companys mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that expand treatment options, improve outcomes and facilitate convenience for women, primarily in the areas of contraception, vaginal health, sexual health, and fertility.

Dars product portfolio includes potential first-in-category candidates in clinical development: Ovaprene, a novel, investigational hormone-free monthly intravaginal contraceptive whoseU.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; DARE-BV1, a unique hydrogel formulation of clindamycin phosphate 2% to treat bacterial vaginosis via a single application; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone therapy following menopause. To learn more about Dars full portfolio of womens health product candidates, and mission to deliver differentiated therapies for women, please visitwww.darebioscience.com.

Dar may announce material information about its finances, product candidates, clinical trials and other matters using the Investors section of its website ( http://ir.darebioscience.com),SECfilings, press releases, public conference calls and webcasts. Dar will use these channels to distribute material information about the company, and may also use social media to communicate important information about the company, its finances, product candidates, clinical trials and other matters. The information Dar posts on its investor relations website or through social media channels may be deemed to be material information. Dar encourages investors, the media, and others interested in the company to review the information Dar posts in the Investors section of its website and to follow these Twitter accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted on the investor relations page of Dars website mentioned above.

Forward-Looking Statements

Dar cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as believe, may, will, estimate, continue, anticipate, design, intend, expect, could, plan, potential, predict, seek, should, would, contemplate, project, target, tend to, or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to the market opportunity and commercial potential for Dars product candidates and managements expectations for Dars product candidates in 2021 and 2022, including anticipated timing for the conduct of clinical trials, topline and other clinical trial data readouts, NDA and IDE submissions, potential FDA review and approval, and a potential commercial partnership for and commercial launch of DARE-BV1. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Dars actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risk and uncertainties related to: Dars ability to raise additional capital when and as needed to advance its product candidates and continue as a going concern; the effects of the COVID-19 pandemic on Dars operations, financial results and condition, and ability to achieve current plans and objectives, including the potential impact of the pandemic on Dars ability to timely enroll, conduct and report results of its clinical trials and on the ability of third parties on which Dar relies to assist in the conduct of its business, including its clinical trials, to fulfill their contractual obligations to Dar; Dars ability to develop, obtain regulatory approval for, and commercialize its product candidates; the failure or delay in starting, conducting and completing clinical trials or obtaining FDA or foreign regulatory approval for Dars product candidates in a timely manner; Dars ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of its product candidates;the risk that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; the risk that developments by competitors make Dars product candidates less competitive or obsolete; failure of Dars product candidates, if approved, to gain market acceptance or obtain adequate coverage from third-party payers; Dars ability to retain its licensed rights to develop and commercialize a product candidate; Dars ability to satisfy the monetary obligations and other requirements in connection with its exclusive, in-license agreements covering the critical patents and related intellectual property related to its product candidates; the risks that the license agreement with Bayer may not become effective and, if it becomes effective, that future payments to Dar under the agreement may be significantly less than the anticipated or potential amounts; Dars failure to timely establish or leverage third-party partnerships or collaborations to commercialize its product candidates, if approved; Dars dependence on third parties to conduct clinical trials and manufacture clinical trial material; Dars ability to adequately protect or enforce its, or its licensors, intellectual property rights; the lack of patent protection for the active ingredients in certain of Dars product candidates which could expose its products to competition from other formulations using the same active ingredients; cyber attacks, security breaches or similar events that compromise Dars technology systems or those of third parties on which it relies and/or significantly disrupt Dars business; and disputes or other developments concerning Dars intellectual property rights. Dars forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Dars risks and uncertainties, you are encouraged to review its documents filed with theSECincluding Dars recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Dar undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Contact:

Investors on behalf of Dar Bioscience, Inc.:Tom MastersonAllele Capital Partnerstmasterson@allelecapital.com646.573.3216

Source: Dar Bioscience, Inc.

Dar Bioscience, Inc. and SubsidiariesCondensed Consolidated Statements of Operations and Comprehensive Loss(Unaudited) Three months ended March 31, 2021 2020 Operating expenses General and administrative $ 1,940,328 $ 1,861,765 Research and development 5,728,206 2,379,804 License fees 25,000 12,500 Total operating expenses 7,693,534 4,254,069 Loss from operations (7,693,534 ) (4,254,069 )Other income 3 1,821 Gain on extinguishment of note payable 369,887 - Net loss $ (7,323,644 ) $ (4,252,248 )Foreign currency translation adjustments (6,841 ) (22,944 )Comprehensive loss $ (7,330,485 ) $ (4,275,192 )Loss per common share - basic and diluted $ (0.16 ) $ (0.18 )Weighted average number of common shares outstanding:Basic and diluted 44,502,582 23,799,396 Dar Bioscience, Inc. and SubsidiariesCondensed Consolidated Balance Sheet Data March 31, 2021 December 31, 2020 (unaudited) Cash and cash equivalents $ 7,660,151 $ 4,669,467 Working capital (deficit) $ 3,490,641 $ (676,689 )Total assets $ 10,518,453 $ 7,550,712 Total stockholders' equity (deficit) $ 3,258,233 $ (1,151,733 )