Loading...
Docoh

Dare Bioscience (DARE)

Daré Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of 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 expand treatment options, improve outcomes and facilitate convenience for women, primarily in the areas of contraception, vaginal health, sexual health, and fertility.

Company profile

Ticker
DARE
Exchange
CEO
Sabrina Martucci Johnson
Employees
Incorporated
Location
Fiscal year end
Former names
Cerulean Pharma Inc., Tempo Pharmaceuticals Inc
SEC CIK
Subsidiaries
Daré Bioscience Operations, Inc. • Daré Bioscience Australia Pty Ltd • Pear Tree Pharmaceuticals, Inc. • Daré MBI Inc. ...

DARE stock data

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

9 Aug 22
30 Sep 22
31 Dec 22
Quarter (USD) Jun 22 Mar 22 Dec 21 Sep 21
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD) Dec 21 Dec 20 Dec 19 Dec 18
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Cash burn rate (est.) Burn method: Change in cash Burn method: Operating income Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 32.07M 32.07M 32.07M 32.07M 32.07M 32.07M
Cash burn (monthly) 2.42M (no burn) (no burn) 2.52M 2.82M 2.45M
Cash used (since last report) 7.33M n/a n/a 7.65M 8.55M 7.43M
Cash remaining 24.74M n/a n/a 24.42M 23.52M 24.64M
Runway (months of cash) 10.2 n/a n/a 9.7 8.4 10.1

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
23 Jun 22 Kelley Susan L. Stock Option Common stock Grant Acquire A No No 1.31 38,000 49.78K 38,000
23 Jun 22 Blanchard Cheryl R Stock Option Common stock Grant Acquire A No No 1.31 38,000 49.78K 38,000
23 Jun 22 Grossman Jessica D. Stock Option Common stock Grant Acquire A No No 1.31 38,000 49.78K 38,000
23 Jun 22 Steele Robin Joan Stock Option Common stock Grant Acquire A No No 1.31 38,000 49.78K 38,000
23 Jun 22 Matz Gregory W Stock Option Common stock Grant Acquire A No No 1.31 38,000 49.78K 38,000
4.2% owned by funds/institutions
13F holders Current Prev Q Change
Total holders 40 37 +8.1%
Opened positions 13 9 +44.4%
Closed positions 10 8 +25.0%
Increased positions 12 14 -14.3%
Reduced positions 5 5
13F shares Current Prev Q Change
Total value 11.48M 15.33M -25.1%
Total shares 7.83M 8.06M -2.8%
Total puts 0 0
Total calls 0 0
Total put/call ratio
Largest owners Shares Value Change
Vanguard 3.45M $5.15M +13.0%
Polaris Venture Partners Iii 1.19M $1.59M 0.0%
Geode Capital Management 698.53K $1.04M +44.7%
BLK Blackrock 602.04K $897K +63.7%
Soviero Asset Management 300K $447K NEW
Millennium Management 256K $381K NEW
STT State Street 178.81K $266K +10.8%
NTRS Northern Trust 140.92K $210K +0.2%
Gsa Capital Partners 125.95K $188K -11.2%
Renaissance Technologies 100.34K $150K NEW
Largest transactions Shares Bought/sold Change
Marshall Wace 73.68K -1.31M -94.7%
Vanguard 3.45M +396.97K +13.0%
Soviero Asset Management 300K +300K NEW
Millennium Management 256K +256K NEW
GS Goldman Sachs 0 -246.61K EXIT
BLK Blackrock 602.04K +234.24K +63.7%
Geode Capital Management 698.53K +215.92K +44.7%
Two Sigma Investments 0 -155.13K EXIT
Founders Financial Securities 0 -103.5K EXIT
Renaissance Technologies 100.34K +100.34K NEW

Financial report summary

?
Competition
Agile TherapeuticsPerrigo
Risks
  • Risks Related to Our Financial Position and Capital Needs
  • We will need to raise additional capital to continue our operations and execute our business strategy.
  • We have a limited operating history, have incurred significant losses since our inception and expect to continue to incur losses for the foreseeable future, which, together with our limited financial resources and substantial capital requirements, make it difficult to assess our prospects.
  • If a commercial counterparty terminates its exclusive license agreement with us or fails to perform as expected, our need for additional capital may significantly increase.
  • Our ability to raise capital may be limited by laws and regulations.
  • We are heavily reliant on our ability to raise capital through capital market transactions. A low trading volume, price and market capitalization together with our lack of revenue, net losses, limited operating history and limited amount of unissued authorized common stock may make it difficult and expensive for us to raise additional capital.
  • Due in part to our limited financial resources, we may fail to select or capitalize on the most scientifically, clinically or commercially promising or profitable indications or therapeutic areas for our product candidates, we may be unable to pursue and complete the clinical trials we would like to pursue and complete, and we may be unable to commence or complete clinical trials and pursue regulatory approvals in accordance with our current timeline expectations.
  • Risks Related to Product Research & Development and Regulatory Approval
  • XACIATO is our first and only FDA-approved product. The FDA’s approval of XACIATO does not provide any assurance or predict that we will be successful in developing or achieving regulatory approval of any other product candidate. If we are unable to successfully conduct and complete development of and obtain regulatory approvals for our investigational products, which may never occur, our business may fail and you could lose all or part of your investment.
  • We depend heavily on the successful development of our lead product candidates, Ovaprene and Sildenafil Cream, 3.6%. Clinical development is a lengthy and expensive process with an inherently uncertain outcome. Failure to successfully develop and obtain regulatory approval to market and sell either of these product candidates would likely adversely affect our business.
  • Delays in the commencement or completion of clinical testing of our product candidates may occur due to any of a number of factors and could result in significantly increased costs and longer timelines and could impact our ability to ever become profitable.
  • Manufacturing and supply delays and disruptions may significantly delay our clinical studies and be expensive for us to resolve.
  • Ovaprene is a drug/device combination and the process for obtaining regulatory approval in the United States will require compliance with complex procedures because concordance between two centers of the FDA (CDRH and CDER) is necessary for approval of this combination product. A change in the FDA’s prior determination that CDER would lead the review of a marketing application for Ovaprene would adversely impact Ovaprene’s development timeline and significantly raise our costs to complete clinical development and obtain regulatory approval for Ovaprene.
  • The factors contributing to female sexual dysfunction disorders, including FSAD, are complex and there is limited clinical trial precedent from which to draw experience, making the design and execution of a clinical trial that demonstrates effectiveness of Sildenafil Cream, 3.6% in treating FSAD more inherently challenging and uncertain compared with investigational products for many other conditions.
  • Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data, and others, including regulatory authorities, may not agree with our interpretation of study data.
  • Our business depends on obtaining regulatory approval to market our product candidates in a timely manner, in particular, FDA approval. The regulatory approval processes of the FDA and comparable foreign authorities are expensive, lengthy, time-consuming, and inherently unpredictable. If we are not able to obtain regulatory approvals for our product candidates, our ability to generate product revenue will be materially impaired.
  • We expect to utilize the FDA’s Section 505(b)(2) pathway for most of our current product candidates and if that pathway is not available, the development of our product candidates will likely take significantly longer, cost significantly more and entail significantly greater complexity and risk than currently anticipated, and, in any case, may not be successful.
  • Our clinical-stage product candidates have only been tested in a small number of women over short periods of use and no data exists regarding a potential increase in fetal abnormalities in pregnant women.
  • Pre-clinical product candidates may not be valued by investors and may be difficult to fund.
  • Several of our product candidates are in pre-clinical stages of development and may never advance to clinical development.
  • The grants supporting the DARE-LARC1 program do not guarantee that its pre-clinical development will be successful or that we will be able to fund its clinical development in the future.
  • Our existing product development and commercialization collaborations are important to our business, and future collaborations may also be important to us. If we are unable to maintain any of these collaborations, if these collaborations are not successful, or if we are unable to establish additional strategic collaborations, our business and prospects may be materially harmed.
  • We rely on third-party suppliers and manufacturers for clinical and commercial supplies of XACIATO and our product candidates, including multiple single source suppliers and manufacturers, and we currently have no plans to build or acquire our own manufacturing capabilities. If these third parties do not perform as we expect, do not maintain their regulatory approvals or become subject to negative circumstances, it could delay, prevent or impair our product development or commercialization efforts, or those of our collaborators.
  • In some cases, we may be contractually required to obtain clinical or commercial product supplies from specific third parties or there may be a limited number of third-party suppliers of raw materials and other components of our product and product candidates, which may heighten our dependence on those third parties and the risk of manufacturing disruptions.
  • Our ability to develop and commercialize XACIATO and our product candidates depends upon maintaining rights granted to us under license agreements with third parties. The loss or impairment of our rights under any of these agreements could have a material adverse effect on our business prospects, operations and viability.
  • Risks Related to Commercialization of XACIATO and Our Product Candidates
  • The commercial success of XACIATO will depend on Organon’s efforts and capabilities, as well as a variety of factors, many of which currently are unknown or uncertain, and if commercialization of XACIATO is not successful, our business and prospects may suffer.
  • If we are unable to establish or maintain commercial collaborations on favorable terms, on a timely basis, or at all, we may need to establish a commercial infrastructure, which would be costly, could delay product launch, and may not be successful.
  • Our product candidates, if approved, and XACIATO will face intense competition and our business and operating results will suffer if we, or our commercial collaborators, fail to compete effectively.
  • The women's health market includes many generic products and growth in generics is expected to continue, which could make the successful introduction of our branded products difficult and expensive.
  • XACIATO and any future products may fail to achieve the degree of market acceptance by physicians, patients third-party payors or others in the medical community necessary for commercial success, which would negatively impact our business.
  • The commercial success of Ovaprene, if approved, will depend on market acceptance of a hormone-free, monthly intravaginal product, availability and effectiveness of alternative contraceptive products and women's preferences, as well as the success of Bayer’s marketing and sales efforts.
  • The commercial success of Sildenafil Cream, 3.6%, if approved, will depend on the availability of alternative products for female sexual dysfunction disorders, the age group for which our product is indicated and women's preferences, in addition to the market's acceptance of our topical cream.
  • The commercial success of DARE-HRT1, if approved, will depend on the availability of alternative products for managing the vasomotor and vaginal symptoms of menopause and women's preferences, in addition to the market's acceptance of our IVR.
  • The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses for prescription medical products. If we or any commercial collaborator is found or alleged to have improperly promoted any of our products for off-label uses, we may become subject to significant liability, including fines, penalties or injunctions, and reputational harm.
  • Unexpected safety, efficacy or quality concerns relating to XACIATO could develop, which could have significant negative consequences for us.
  • If we suffer negative publicity concerning the safety or efficacy of XACIATO or the product candidates we develop, our reputation could be harmed, product sales could be adversely affected or we may be forced to cease or curtail product development efforts.
  • We are and will remain subject to ongoing regulatory requirements even after obtaining regulatory approval for a product candidate.
  • Failure to successfully obtain coverage and reimbursement for XACIATO and any future products in the United States, or the availability of coverage only at limited levels, would diminish our ability, or that of a commercial collaborator, to generate net product revenue.
  • Even seemingly small copayments or other cost-sharing requirements could dramatically reduce the market potential for XACIATO and our product candidates.
  • As no FDA-approved treatments for FSAD currently exist, there is little precedent to help assess whether health insurance plans will cover Sildenafil Cream, 3.6% if approved.
  • The commercial success of products we develop, if approved, will be impacted by the prescribing information approved by the FDA and comparable regulatory authorities outside the United States.
  • Drug products and drug/device combination products are complex to manufacture, and manufacturing disruptions may occur that could cause significant delays and disruption in the supply of XACIATO and any future product.
  • If competitors obtain approval for generic versions of XACIATO or any future products, our business may suffer.
  • We will need to obtain FDA approval of any proposed prescription medical product name, and any failure or delay associated with such approval may adversely affect our business.
  • Even if we receive marketing approval from the FDA, we may fail to receive similar approvals outside the United States, which could substantially limit the value of our products.
  • Risks Related to Employee Matters and Managing Our Growth
  • We have a relatively small number of employees to manage and operate our business.
  • If we fail to attract and retain management and other key personnel, we may not successfully complete development of, obtain regulatory approval for or commercialize our product candidates, or otherwise implement our business plan.
  • We may not be successful in our efforts to identify and acquire or in-license additional product candidates or technologies, which may limit our growth potential.
  • Risks Related to Our Intellectual Property
  • Our failure to adequately protect or enforce our and our licensors’ intellectual property rights could materially harm our proprietary position in the marketplace or prevent or impede the commercialization of our current and potential future products.
  • The patents and the patent applications covering our IVR product candidates cover the method of delivery and the device and our market opportunity may be limited by the lack of patent protection for the active ingredients themselves and other formulations, delivery technology and systems that may be developed by competitors.
  • The patents and the patent applications covering the use and delivery of DARE-VVA1 and our market opportunity may be limited by the lack of patent protection for the active ingredient itself and other formulations, delivery technology and systems that may be developed by competitors.
  • We may become involved in patent litigation or other intellectual property proceedings relating to our future product approvals, which could result in liability for damages or delay or stop our development and commercialization efforts.
  • We also rely upon trade secrets to protect our technology, product and product candidates, and trade secrets can be difficult to maintain and enforce.
  • Confidentiality agreements with employees and others may not adequately prevent disclosure of our know-how, trade secrets and other proprietary information and may not adequately protect our intellectual property, which could limit our ability to compete.
  • Provisions in our agreements with governmental agencies and non-profit organizations may affect our intellectual property rights and the value of our development programs to our company.
  • The COVID-19 pandemic has negatively impacted our business and, in the future, may materially and adversely affect our business, financial condition and results and stock price, including by increasing the cost and timelines for our clinical development programs.
  • Product liability lawsuits against us could cause us to incur substantial liabilities.
  • Our current or future employees, clinical investigators, consultants and commercial collaborators may engage in misconduct or other improper activities, including non-compliance with regulatory standards.
  • The pharmaceutical and medical device industries are highly regulated and subject to various fraud and abuse laws, including, without limitation, the U.S. federal Anti-Kickback Statute, the U.S. federal False Claims Act and the U.S. Foreign Corrupt Practices Act.
  • Cyber-attacks, security breaches, loss of data and other disruptions to our information technology systems or those of our collaborators and third-party service providers could compromise sensitive information related to our business, delay or prevent us from accessing critical information or expose us to liability, any of which could adversely affect our business and our reputation.
  • Our business may be adversely affected by unfavorable or unanticipated macroeconomic conditions and geopolitical events.
  • We expect to continue to incur increased costs as a result of operating as a public company, and our management will have to devote substantial time to compliance initiatives and corporate governance practices.
  • We are a smaller reporting company and a non-accelerated filer and the reduced disclosure requirements available to us may make our common stock less attractive to investors.
  • The price of our common stock may rise and fall rapidly, substantial price fluctuations may occur regardless of developments in our business or our operating performance, and you could lose all or part of your investment as a result.
  • There is no assurance that we will continue satisfying the listing requirements of the Nasdaq Capital Market.
  • A significant portion of our total outstanding shares of common stock may be sold into the public market at any point, which could cause the market price of our common stock to drop significantly, even if our business is doing well.
  • The sale of our common stock in ATM offerings may cause substantial dilution to our existing stockholders, and such sales, or the anticipation of such sales, may cause the price of our common stock to decline.
  • The exercise of our outstanding options and warrants may result in significant dilution to our stockholders.
  • We may issue preferred stock with terms that could dilute the voting power or reduce the value of our common stock.
  • We do not anticipate paying any cash dividends on our common stock in the foreseeable future; capital appreciation, if any, will be your sole source of gain as a holder of our shares.
  • Provisions in our certificate of incorporation, our by-laws or Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our common stock.
  • Provisions in our by-laws could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • If we fail to attract or maintain securities analysts to publish research on our business or if they publish or convey negative evaluations of our business, the price of our stock could decline.
Management Discussion
  • Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
  • In this report, “we,” “us,” “our,” “Daré” or the “Company” refer collectively to Daré Bioscience, Inc. and its wholly owned subsidiaries, unless otherwise stated or the context otherwise requires. All information presented in this report is based on our fiscal year. Unless otherwise stated, references to particular years, quarters, months or periods refer to our fiscal years ending December 31 and the associated quarters, months and periods of those fiscal years.
  • Daré Bioscience® is a registered trademark of Daré Bioscience, Inc. and XACIATO™ is a trademark of Daré Bioscience, Inc. with registration pending. Ovaprene® is a registered trademark licensed to Daré Bioscience, Inc. All other trademarks, service marks or trade names appearing in this report are the property of their respective owners. Use or display by us of other parties’ trademarks, service marks or trade names is not intended to and does not imply a relationship with, or endorsements or sponsorship of, us by the trademark, service mark or trade name owners.

Content analysis

?
Positive
Negative
Uncertain
Constraining
Legalese
Litigous
Readability
H.S. junior Avg
New words: animal, biocompatibility, Certificate, chemical, Comprehensive, confidence, Delaware, EPS, exploratory, forfeited, guide, inclusion, predicate, repurchase, resolved, sheep, statistician, step, stockholder, sublicensee, superseded, unachieved, understand, unspent, vi
Removed: adaptive, Australian, certainty, comprised, Guidance, implemented, line, meaningful, published, true, underpowered, variability