GRAY Graybug Vision Inc.

3.16
-0.23  -7%
Previous Close 3.39
Open 3.29
52 Week Low 3.05
52 Week High 37.8799
Market Cap $67,259,576
Shares 21,284,676
Float 11,762,794
Enterprise Value $1,336,059
Volume 186,513
Av. Daily Volume 184,639
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Upcoming Catalysts

Drug Stage Catalyst Date
GB-102 (ALTISSIMO)
Wet age-related macular degeneration
Phase 2b
Phase 2b
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Drug Pipeline

Drug Stage Notes
GB-401
Glaucoma
Phase 1
Phase 1
Phase 1 trial to commence 1H 2022.
GB-102
Diabetic macular edema (DME)
Phase 2b
Phase 2b
Phase 2b trial to be initiated 2H 2021.
GB-102
Wet age-related macular degeneration (AMD)
Phase 3
Phase 3
Phase 3 trials to be initiated 2H 2021.

Latest News

  1. BALTIMORE, Sept. 30, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today announced that Fred Guerard, PharmD, Chief Executive Officer of Graybug Vision, will participate in the following events at the Ophthalmology Innovation Summit (OIS) Retina on Thursday, October 7, 2021, in San Antonio, Texas. The OIS Retina conference is being held in conjunction with the American Society of Retina Specialists (ASRS) 39th Annual Scientific Meeting. Dr. Guerard will be a speaker at the following events:

    • "Innovation Showcase" (company presentation)
      11:05 a.m. ET / 10:05 a.m. CT / 8:05 a.m…

    BALTIMORE, Sept. 30, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today announced that Fred Guerard, PharmD, Chief Executive Officer of Graybug Vision, will participate in the following events at the Ophthalmology Innovation Summit (OIS) Retina on Thursday, October 7, 2021, in San Antonio, Texas. The OIS Retina conference is being held in conjunction with the American Society of Retina Specialists (ASRS) 39th Annual Scientific Meeting. Dr. Guerard will be a speaker at the following events:

    • "Innovation Showcase" (company presentation)

      11:05 a.m. ET / 10:05 a.m. CT / 8:05 a.m. PT; and
    • "Finding and Funding Assets in Retina" (panel discussion)

      4:55 p.m. ET / 3:55 p.m. CT / 1:55 p.m. PT

    About Graybug

    Graybug is a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve. The company's proprietary ocular delivery technologies are designed to maintain effective drug levels in ocular tissue for six months and potentially longer, improving disease management, reducing healthcare burdens and ultimately delivering better clinical outcomes. Graybug's lead product candidate, GB-102, a formulation of the pan-vascular endothelial growth factor (VEGF) inhibitor, sunitinib malate targeting a six-month or longer dosing regimen, inhibits multiple neovascular pathways for the intravitreal treatment of retinal diseases, including wet age-related macular degeneration. Graybug's other product candidates developed using its proprietary technologies also include GB-401, an injectable sustained-release formulation of a beta-adrenergic blocker prodrug, for primary open-angle glaucoma, with a dosing regimen of once every six months or longer. Founded in 2011 on the basis of technology licensed from the Johns Hopkins University School of Medicine, Graybug has offices in Redwood City, California and in Baltimore, Maryland. For more information, please visit www.graybug.vision.

    Investor Contact

    IR@graybug.vision

    (650) 487-2409
    Media Contact

    media@graybug.vision

    (404) 384-0067



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    • 55% of GB-102 1mg patients in Extension Study experienced duration of 12+ months, while maintaining their visual acuity and central retinal thickness
    • 73% reduction of injection burden for patients participating in Extension Study
    • GB-102 1mg continued to indicate a favorable safety profile and was well-tolerated

    BALTIMORE, Sept. 28, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today provided full-data analysis from the 18-month Phase 2b ALTISSIMO trial of GB-102 for the treatment of wet age-related macular degeneration (wet AMD), Graybug's proprietary formulation of sunitinib malate…

    • 55% of GB-102 1mg patients in Extension Study experienced duration of 12+ months, while maintaining their visual acuity and central retinal thickness
    • 73% reduction of injection burden for patients participating in Extension Study
    • GB-102 1mg continued to indicate a favorable safety profile and was well-tolerated

    BALTIMORE, Sept. 28, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today provided full-data analysis from the 18-month Phase 2b ALTISSIMO trial of GB-102 for the treatment of wet age-related macular degeneration (wet AMD), Graybug's proprietary formulation of sunitinib malate injected twice-a-year intravitreally.

    The ALTISSIMO trial was a masked and controlled Phase 2b dose-ranging study of two doses of GB-102, 1mg and 2mg, with a single control arm of patients on 2mg aflibercept, conducted across 33 study sites in the United States. The primary endpoint was median time to first supportive therapy with a vascular endothelial growth factor (VEGF) inhibitor, and secondary endpoints were safety and pharmacodynamics, measured as mean change in best-corrected visual acuity (BCVA) and mean change in central subfield thickness (CST) of the retina. As previously reported, the development of GB-102 2mg was terminated in 2020 following an interim safety analysis, and ALTISSIMO was not powered to assess non-inferiority to aflibercept.

    ALTISSIMO comprised two phases, the first of which was a 12-month treatment phase, or Core Study, in which GB-102 patients were dosed at Day 1 and Month 6, while a control arm received aflibercept every other month. The second phase of ALTISSIMO was a six-month extended observation phase, or Extension Study, in which patients were monitored without additional treatment to determine the duration of effect measured from their last treatment during the Core Study. Participation in the Extension Study was voluntary, but only patients who completed all study visits, and did not require supportive therapy at their Month 12 visit during the Core Study, were eligible. 58% of the patients who completed the Core Study were eligible and agreed to enter the Extension Study, with 11 patients participating in the GB-102 1mg arm.

    By its design, patients could not achieve longer than a six-month duration during the Core Study. The Extension Study provided up to an additional six months for patients to demonstrate longer duration, which resulted in 55% of GB-102 1mg patients experiencing a treatment duration of 12 months or longer, while maintaining visual acuity and central retinal thickness. This is the longest duration ever achieved with an intravitreal injection in a randomized, masked, and controlled clinical trial in wet AMD. In addition, the injection burden was reduced by 73% on an annualized basis for those GB-102 1mg patients who participated in the six-month Extension Study.

    As in the Core Study, GB-102 1mg continued to be well-tolerated and maintained a favorable safety profile during the Extension Study. No drug-related adverse events or vision-threatening inflammation were reported.

    "The Extension Study gave us our first opportunity to see duration beyond six months in a masked and controlled trial, and we are very excited that the majority of patients volunteering for extended observation achieved a treatment duration of 12 months or longer," said Parisa Zamiri, MD, PhD, Chief Medical Officer of Graybug. "Furthermore, the significant reduction in injection burden continued throughout the Extension Study and showed that GB-102 1mg has the potential to significantly improve compliance compared to the current standard of care," Dr. Zamiri concluded.

    Graybug continues to optimize its technology platform and is developing additional formulations that have the potential to preserve the durability of GB-102 1mg microparticles while minimizing the risk of dispersion. These new and enhanced formulations, including injectable implants, may also simplify the drug reconstitution process and the injection technique, both of which are sources of variability in clinical outcomes. These innovations have already been incorporated into the development programs of both GB-102 and GB-401. Graybug anticipates that its GB-401 implant program for glaucoma will enter a Phase 1 trial in the second half of 2022. Given the 12-month or longer duration observed with GB-102 in the ALTISSIMO 18-month trial, Graybug decided to stop the further development of GB-103, which was designed to maintain therapeutic drug levels in the retinal tissue for 12 months with a single injection.

    "We are encouraged by the Extension Study data that indicate a class-leading durability of GB-102 1mg of 12 months, or longer," said Fred Guerard, PharmD, Chief Executive Officer, Graybug Vision. "These data further support the significant commercial opportunity that GB-102 1mg could represent. Our search for a partner to fund the further clinical development of GB-102 is ongoing."

    About Graybug

    Graybug is a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve. The company's proprietary ocular delivery technologies are designed to maintain effective drug levels in ocular tissue for six months and potentially longer, improving disease management, reducing healthcare burdens and ultimately delivering better clinical outcomes. Graybug's lead product candidate, GB-102, a formulation of the pan-vascular endothelial growth factor (VEGF) inhibitor, sunitinib malate targeting a six-month or longer dosing regimen, inhibits multiple neovascular pathways for the intravitreal treatment of retinal diseases, including wet age-related macular degeneration. Graybug's other product candidates developed using its proprietary technologies also include GB-401, an injectable sustained release formulation of a beta-adrenergic blocker prodrug, for primary open-angle glaucoma, with a dosing regimen of once every six months or longer. Founded in 2011 on the basis of technology licensed from the Johns Hopkins University School of Medicine, Graybug has offices in Redwood City, California, and in Baltimore, Maryland. For more information, please visit www.graybug.vision.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 including, but not limited to, statements regarding the company's clinical pipeline, its ability to timely identify a partner to fund further development of GB-102 for wet AMD on reasonable terms if at all, the timing or outcomes of its interactions with regulatory authorities, its ability to advance GB-102, GB-401, or any future product candidate through preclinical or clinical development, its ability to achieve its anticipated milestones within the timing outlined above or at all, its ability to conduct planned operations within the evolving constraints arising from the COVID-19 pandemic, and the timing, cost, and results of its clinical trials. Forward-looking statements are subject to risks and uncertainties that may cause the company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties described under the heading "Risk Factors" in the company's annual report on Form 10-K filed for the year ended December 31, 2020, in its subsequent quarterly reports on Form 10-Q, and in the other reports the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

    Investor Contact

    IR@graybug.vision

    (650) 487-2409

    Media Contact

    media@graybug.vision

    (404) 384-0067


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  2. BALTIMORE, Sept. 21, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today announced that Fred Guerard, PharmD, Chief Executive Officer of Graybug Vision, will present at the 2021 Cantor Virtual Global Healthcare Conference on Tuesday, September 28, 2021 at 11:20 a.m. ET / 8:20 a.m. PT. Dr. Guerard will provide a corporate update, including a full analysis of the 18-month data from the ALTISSIMO Phase 2b trial of GB-102 1mg.  

    A live webcast of the presentation will be available in the Investors and Media section of the company's website at https://investors.graybug.vision/news-events/events-presentations

    BALTIMORE, Sept. 21, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today announced that Fred Guerard, PharmD, Chief Executive Officer of Graybug Vision, will present at the 2021 Cantor Virtual Global Healthcare Conference on Tuesday, September 28, 2021 at 11:20 a.m. ET / 8:20 a.m. PT. Dr. Guerard will provide a corporate update, including a full analysis of the 18-month data from the ALTISSIMO Phase 2b trial of GB-102 1mg.  

    A live webcast of the presentation will be available in the Investors and Media section of the company's website at https://investors.graybug.vision/news-events/events-presentations, with a replay available shortly after the live event.  

    About Graybug

    Graybug is a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve. The company's proprietary ocular delivery technologies are designed to maintain effective drug levels in ocular tissue for six months and potentially longer, improving disease management, reducing healthcare burdens and ultimately delivering better clinical outcomes. Graybug's lead product candidate, GB-102, a formulation of the pan-vascular endothelial growth factor (VEGF) inhibitor, sunitinib malate targeting a six-month or longer dosing regimen, inhibits multiple neovascular pathways for the intravitreal treatment of retinal diseases, including wet age-related macular degeneration. Graybug's other product candidates developed using its proprietary technologies also include GB-401, an injectable sustained-release formulation of a beta-adrenergic blocker prodrug, for primary open-angle glaucoma, with a dosing regimen of once every six months or longer, and GB-103, a longer-acting version of GB-102, designed to maintain therapeutic drug levels in the retinal tissue for 12 months with a single injection. Founded in 2011 on the basis of technology licensed from the Johns Hopkins University School of Medicine, Graybug is headquartered in Baltimore, Maryland. For more information, please visit www.graybug.vision.

    Investor Contact

    IR@graybug.vision

    (650) 487-2409



    Media Contact

    media@graybug.vision

    (404) 384-0067





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    • Phase 2/3 ReMEDy2 Trial in AIS for Stroke Outcomes and Stroke Recurrence on Track for Initiation Summer 2021
    • Positive REDUX Phase 2 Interim Data Announced for CKD: IgA Nephropathy Data Indicate Statistically & Clinically Significant 33% Reduction in Albuminuria (UACR).
    • Board of Directors Strengthened with Election of Two Pharma Industry Veterans

     Conference Call and Webcast August 12 at 8:00 am Eastern Time / 7:00 am Central Time

    DiaMedica Therapeutics Inc. (NASDAQ:DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, today provided a business update and financial results for the quarter ended June 30, 2021. DiaMedica will host a conference call Thursday…

    • Phase 2/3 ReMEDy2 Trial in AIS for Stroke Outcomes and Stroke Recurrence on Track for Initiation Summer 2021
    • Positive REDUX Phase 2 Interim Data Announced for CKD: IgA Nephropathy Data Indicate Statistically & Clinically Significant 33% Reduction in Albuminuria (UACR).
    • Board of Directors Strengthened with Election of Two Pharma Industry Veterans

     Conference Call and Webcast August 12 at 8:00 am Eastern Time / 7:00 am Central Time

    DiaMedica Therapeutics Inc. (NASDAQ:DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, today provided a business update and financial results for the quarter ended June 30, 2021. DiaMedica will host a conference call Thursday, August 12, 2021, at 7:00AM Central Time/8:00AM Eastern Time to discuss its business update and second quarter financial results.

    Pivotal Phase 2/3 ReMEDy Trial on Track for Summer 2021 Initiation; Prevention of Stroke Recurrence is being Added as Independent Co-Primary Endpoint

    DiaMedica's Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for an adaptive Phase 2/3 clinical trial of DM199 was accepted by the FDA in mid-May 2021, and the Company expects to formally initiate the study by the end of this summer.

    The clinical trial design is a double blinded, placebo controlled, randomized study of approximately 350 participants, based on a 90% powering for statistical significance on the primary endpoint of modified Rankin Scale (mRS) at day 90 with 24-hour treatment window from onset of stroke symptoms. The prevention of stroke recurrence is being added as an independent co-primary endpoint for this study based on the statistically significant 13% absolute reduction in severe recurrent strokes observed in the ReMEDy Phase 2 study. Secondary endpoints will include mRS shift, NIHSS and Barthel Index scores, deaths, safety and tolerability measures, and biomarkers relating to KLK1.

    The trial population includes acute ischemic stroke (AIS) patients who are not eligible for and/or who do not receive tissue plasminogen activator (tPA) and do not have large vessel occlusions. This group represents up to 80% of all AIS patients, for whom there is no treatment option other than supportive care. DiaMedica believes that the proposed trial has the potential to serve as a pivotal registration study of DM199 in this patient population.

    DM199 for the Treatment of Chronic Kidney Disease (CKD)

    Interim data from the Phase 2 REDUX trial was announced in June 2021. The Company highlights that DM199 demonstrated clinically meaningful improvements in kidney function in IgA Nephropathy as measured by simultaneously stabilizing estimated glomerular filtration rate (eGFR) and decreasing urinary albumin-to-creatinine ratio (UACR). Interim data from 11 subjects with moderate to severe albuminuria (baseline UACR>500) showed an average decrease in UACR of -33% (P=0.002) with stable eGFR.

    Additionally, DM199 was well tolerated across all cohorts, with no DM199 related severe adverse events or discontinuations due to drug-related adverse events (AEs). The AEs observed were generally mild to moderate in severity, with the most common being local injection site irritation that resolved without medical intervention.

    DiaMedica is preparing to provide a more complete update on the interim study results to be presented at the American Society of Nephrology Annual Meeting in November 2021.

    As of July 31, 2021, DiaMedica had enrolled 75 subjects, including 20 African American subjects into Cohort I, 22 subjects with IgAN into Cohort II and completed enrollment with 33 subjects with Type 2 diabetes, hypertension and albuminuria into Cohort III. The Company has continued to experience slower than expected enrollment in the first two Cohorts of the REDUX study and believes this is due to continued concerns of potential study subjects related to visiting clinical study sites. DiaMedica is evaluating the effects of the recent surge in COVID-19 infections related to the Delta variant and will provide an update on the anticipated completion of Cohort I and Cohort II when the Company is able to reasonably estimate timing.

    Two Pharma Industry Veterans Added to DiaMedica Board of Directors

    In July 2021, the Company announced the election of two experienced executives to its Board of Directors. Joining the Board are:

    • Amy Burroughs, has held senior leadership and advisory roles with a broad range of public and private biopharmaceutical companies over the last 20 years. She is currently president and chief executive officer of Cleave Therapeutics, a clinical stage, venture backed oncology company. Previously, she served as executive in residence at 5AM Ventures, a leading venture capital firm focused on building next-generation life science companies, and a senior advisor to Crinetics (NASDAQ:CRNX). She began her biopharmaceutical career at Genentech, where she held key roles in commercial strategy and planning across the portfolio and led the neurology commercial team.
    • Charles Semba, M/D., has over 20 years of drug development experience in public and private biotechnology companies and is a recognized expert in endovascular therapy, thrombolysis, mechanical thrombectomy, and endovascular surgery. He is Chief Medical Officer (CMO) at Eluminex Biosciences and has served as CMO for SARcode Bioscience (acquired by Shire/Takeda), ForSight VISION5 (acquired by Allergan), and Graybug Vision (NASDAQ:GRAY). He has held senior leadership roles as Vice President Ophthalmic Medicine at Shire/Takeda and Ophthalmology Group Head at Genentech. Dr. Semba led the clinical development of ranibizumab (LUCENTIS®) and lifitegrast (XIIDRA®). He also led FDA approval for CathFlo Activase® (Alteplase) for ischemic stroke.

    Financial Results

    Research and development (R&D) expenses increased to $2.2 million for the three months ended June 30, 2021, up from $1.6 million for the three months ended June 30, 2020, an increase of $0.6 million. R&D expenses increased to $4.6 million for the six months ended June 30, 2021, compared to $2.9 million for the six months ended June 30, 2020, an increase of $1.7 million. The increase for the six-month comparison was primarily due to a number of factors including costs incurred for the pivotal ReMEDy2 clinical study, increased year-over-year costs related to manufacturing process development and the REDUX Phase 2 CKD study, as well as increased personnel costs associated with additional staff added to support R&D operations. These increases were partially offset by decreased costs incurred for the ReMEDy Phase 2 stroke study which completed in the prior year.

    General and administrative (G&A) expenses were $1.2 million for the three months ended June 30, 2021, up from $1.1 million for the three months ended June 30, 2020. G&A expenses increased to $2.4 million for the six months ended June 30, 2021, up $0.2 million from $2.2 million for the six months ended June 30, 2020. The increase for the six-month comparison was primarily due to increased professional services costs and increased personnel costs to support the Company's expanding clinical programs.

    Balance Sheet and Cash Flow

    The Company had cash, cash equivalents and marketable securities of $21.3 million, current liabilities of $1.4 million and working capital of $20.2 million as of June 30, 2021, compared to $27.5 million in cash, cash equivalents and marketable securities, $2.0 million in current liabilities and $25.9 million in working capital as of December 31, 2020. The decreases in combined cash, cash equivalents and marketable securities and in working capital are due primarily to increased clinical study costs associated with preparing for the ReMEDy2 Phase 2/3 stroke study, costs related to the REDUX Phase 2 CKD study and increased costs related manufacturing development.

    Net cash used in operating activities for the six months ended June 30, 2021 was $6.4 million compared to $3.8 million for the six months ended June 30, 2020. This increase relates primarily to the increase in the net loss, partially offset by non-cash share-based compensation and the effects of the changes in operating assets and liabilities.

    Conference Call and Webcast Information

    DiaMedica Management will host a conference call and webcast to discuss its business update and second quarter 2021 financial results on Thursday, August 12, 2021, at 7:00AM Central Time:

    Date:

    Thursday, August 12, 2021

    Time:

    7:00 AM CT / 8:00 AM ET

    Web access:

    https://event.on24.com/wcc/r/3192933/FBC5C2BE41E26E2C70F89B28EC5DB100

    Dial In:

    (844) 557-8483 (domestic)

    (825) 312-2381 (international)

    Conference ID:

    4148874

    Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on DiaMedica's website, under investor relations - events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until August 19, 2021, by dialing (800) 585-8367 (US Toll Free), (416) 621-4642 (International), and entering the replay passcode: 4148874.

    About DM199

    DM199 is a recombinant (synthetic) form of human tissue kallikrein-1 (KLK1). KLK1 is a serine protease (protein) that plays an important role in the regulation of diverse physiological processes including blood flow, inflammation, fibrosis, oxidative stress and neurogenesis via a molecular mechanism that increases production of nitric oxide and prostaglandin. KLK1 deficiency may play a role in multiple vascular and fibrotic diseases such as chronic kidney disease, retinopathy, stroke, vascular dementia, and resistant hypertension where current treatment options are limited or ineffective. DiaMedica is the first company to have developed a recombinant form of the KLK1 protein. The KLK1 protein, produced from porcine pancreas and human urine, has been used to treat patients in Japan, China and South Korea for decades. DM199 is currently being studied in patients with acute ischemic stroke and patients with chronic kidney disease.

    About DiaMedica Therapeutics Inc.

    DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company committed to improving the lives of people suffering serious diseases. DiaMedica's lead candidate DM199 is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality for the treatment of acute ischemic stroke (AIS) and chronic kidney disease (CKD). For more information visit our website at www.diamedica.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and forward-looking information that are based on the beliefs of management and reflect management's current expectations. When used in this press release, the words "estimate," "believe," "anticipate," "intend," "expect," "plan," "continue," "look forward," "will," "may" or "should," the negative of these words or such variations thereon or comparable terminology and the use of future dates are intended to identify forward-looking statements and information. The forward-looking statements and information in this press release include statements regarding the anticipated clinical benefits and success of DM199, the timing and requirements of its clinical programs, including its anticipated Phase 2/3 trial for DM199 in patients with AIS, which DiaMedica believes will commence in Summer 2021 and has the potential to serve as a pivotal registration study of DM199 in that patient population, and enrollment, clinical results and ability to achieve clinical milestones. Such statements and information reflect management's current view and DiaMedica undertakes no obligation to update or revise any of these statements or information. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Applicable risks and uncertainties include, among others, the possibility of unfavorable results from DiaMedica's ongoing or future clinical trials of DM199, including the fact that the interim REDUX study data previously released is preliminary and interim and final results may differ materially from the data previously released; the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; the possibility of unfavorable results from subsequent analysis of existing or future data from the REDUX study or future studies of DM199; DiaMedica's plans to develop, obtain regulatory approval for and commercialize its DM199 product candidate for the treatment of AIS and CKD and its expectations regarding the benefits of DM199; DiaMedica's ability to conduct successful clinical testing of DM199 and within its anticipated parameters, costs and timeframes; the perceived benefits of DM199 over existing treatment options; the potential direct or indirect impact of the COVID-19 pandemic on DiaMedica's business, including its clinical trials; DiaMedica's reliance on collaboration with third parties to conduct clinical trials; DiaMedica's ability to continue to obtain funding for its operations, including funding necessary to complete planned clinical trials and obtain regulatory approvals for DM199 for AIS and CKD, and the risks identified under the heading "Risk Factors" in DiaMedica's annual report on Form 10-K for the fiscal year ended December 31, 2020 and subsequent U.S. Securities and Exchange Commission filings by DiaMedica. The forward-looking information contained in this press release represents the expectations of DiaMedica as of the date of this press release and, accordingly, is subject to change after such date. Readers should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While DiaMedica may elect to, it does not undertake to update this information at any particular time except as required in accordance with applicable laws.

    DiaMedica Therapeutics Inc.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (In thousands, except share and per share amounts)

    (Unaudited)

     

     

    Three Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

    2021

     

    2020

     

    2021

     

    2020

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

    Research and development

    $

    2,156

     

     

    $

    1,600

     

     

    $

    4,562

     

     

    $

    2,949

     

    General and administrative

     

    1,209

     

     

     

    1,108

     

     

     

    2,422

     

     

     

    2,163

     

    Operating loss

     

    (3,365

    )

     

     

    (2,708

    )

     

     

    (6,984

    )

     

     

    (5,112

    )

     

     

     

     

     

     

     

     

     

     

     

     

    Other income:

     

     

     

     

     

     

     

     

     

     

     

    Governmental assistance - research incentives

     

    -

     

     

     

    (65

    )

     

     

    -

     

     

     

    (180

    )

    Other income, net

     

    (98

    )

     

     

    (178

    )

     

     

    (102

    )

     

     

    (51

    )

    Total other income

     

    (98

    )

     

     

    (243

    )

     

     

    (102

    )

     

     

    (231

    )

     

     

     

     

     

     

     

     

     

     

     

     

    Loss before income tax expense

     

    (3,267

    )

     

     

    (2,465

    )

     

     

    (6,882

    )

     

     

    (4,881

    )

     

     

     

     

     

     

     

     

     

     

     

     

    Income tax expense

     

    7

     

     

     

    9

     

     

     

    14

     

     

     

    18

     

     

     

     

     

     

     

     

     

     

     

     

     

    Net loss

     

    (3,274

    )

     

     

    (2,474

    )

     

     

    (6,896

    )

     

     

    (4,899

    )

     

     

     

     

     

     

     

     

     

     

     

     

    Other comprehensive income (loss)

     

     

     

     

     

     

     

     

     

     

     

    Unrealized gain (loss) on marketable securities

     

     

     

     

    (13

    )

     

     

    1

     

     

     

    27

     

     

     

     

     

     

     

     

     

     

     

     

     

    Net loss and comprehensive loss

    $

    (3,274

    )

     

    $

    (2,487

    )

     

    $

    (6,895

    )

     

    $

    (4,872

    )

     

     

     

     

     

     

     

     

     

     

     

     

    Basic and diluted net loss per share

    $

    (0.17

    )

     

    $

    (0.17

    )

     

    $

    (0.37

    )

     

    $

    (0.36

    )

    Weighted average shares outstanding – basic and diluted

     

    18,786,157

     

     

     

    14,139,074

     

     

     

    18,776,461

     

     

     

    13,623,400

     

    DiaMedica Therapeutics Inc.

    Condensed Consolidated Balance Sheets

    (In thousands, except share amounts)

     

     

     

    June 30, 2021

     

    December 31, 2020

     

     

    (unaudited)

     

     

     

    ASSETS

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    2,228

     

     

    $

    7,409

     

    Marketable securities

     

     

    19,067

     

     

     

    20,098

     

    Amounts receivable

     

     

    16

     

     

     

    340

     

    Prepaid expenses and other assets

     

     

    318

     

     

     

    74

     

    Total current assets

     

     

    21,629

     

     

     

    27,921

     

     

     

     

     

     

     

     

    Non-current assets:

     

     

     

     

     

     

    Operating lease right-of-use asset

     

     

    72

     

     

     

    100

     

    Property and equipment, net

     

     

    73

     

     

     

    74

     

    Total non-current assets

     

     

    145

     

     

     

    174

     

     

     

     

     

     

     

     

    Total assets

     

    $

    21,774

     

     

    $

    28,095

     

     

     

     

     

     

     

     

    LIABILITIES AND EQUITY

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

    Accounts payable

     

    $

    239

     

     

    $

    1,099

     

    Accrued liabilities

     

     

    1,132

     

     

     

    864

     

    Finance lease obligation

     

     

    5

     

     

     

    6

     

    Operating lease obligation

     

     

    64

     

     

     

    59

     

    Total current liabilities

     

     

    1,440

     

     

     

    2,028

     

     

     

     

     

     

     

     

    Non-current liabilities:

     

     

     

     

     

     

    Finance lease obligation, non-current

     

     

    5

     

     

     

    7

     

    Operating lease obligation, non-current

     

     

    11

     

     

     

    46

     

    Total non-current liabilities

     

     

    16

     

     

     

    53

     

     

     

     

     

     

     

     

    Shareholders' equity:

     

     

     

     

     

     

    Common shares, no par value; unlimited authorized; 18,786,157 and 18,746,157 shares issued and outstanding, as of June 30, 2021 and December 31, 2020, respectively

     

     

     

     

     

     

    Paid-in capital

     

     

    96,126

     

     

     

    94,925

     

    Accumulated other comprehensive loss

     

     

    (3

    )

     

     

    (2

    )

    Accumulated deficit

     

     

    (75,805

    )

     

     

    (68,909

    )

    Total shareholders' equity

     

     

    20,318

     

     

     

    26,014

     

    Total liabilities and shareholders' equity

     

    $

    21,774

     

     

    $

    28,095

     

    DiaMedica Therapeutics Inc.

    Condensed Consolidated Statements of Cash Flows

    (In thousands)

    (Unaudited)

     

     

     

    Six Months Ended June 30,

     

     

    2021

     

    2020

    Cash flows from operating activities:

     

     

     

     

    Net loss

     

    $

    (6,896

    )

     

    $

    (4,899

    )

    Adjustments to reconcile net loss to net cash used in operating activities:

     

     

     

     

    Share-based compensation

     

     

    957

     

     

     

    829

     

    Amortization of premium (discount) on marketable securities

     

     

    38

     

     

     

    (23

    )

    Non-cash lease expense

     

     

    28

     

     

     

    26

     

    Depreciation

     

     

    12

     

     

     

    11

     

    Changes in operating assets and liabilities:

     

     

     

     

    Amounts receivable

     

     

    324

     

     

     

    504

     

    Prepaid expenses and other assets

     

     

    (244

    )

     

     

    (146

    )

    Accounts payable

     

     

    (860

    )

     

     

    370

     

    Accrued liabilities

     

     

    239

     

     

     

    (494

    )

    Net cash used in operating activities

     

     

    (6,402

    )

     

     

    (3,822

    )

     

     

     

     

     

    Cash flows from investing activities:

     

     

     

     

    Purchase of marketable securities

     

     

    (25,244

    )

     

     

    (8,799

    )

    Maturities of marketable securities

     

     

    26,235

     

     

     

    6,000

     

    Purchases of property and equipment

     

     

    (13

    )

     

     

    (2

    )

    Proceeds from disposition of property and equipment

     

     

    2

     

     

     

     

    Net cash provided by (used in) investing activities

     

     

    980

     

     

     

    (2,801

    )

     

     

     

     

     

    Cash flows from financing activities:

     

     

     

     

    Proceeds from issuance of common shares, net of offering costs

     

     

     

     

     

    7,682

     

    Proceeds from the exercise of stock options

     

     

    244

     

     

     

    16

     

    Principal payments on finance lease obligations

     

     

    (3

    )

     

     

    (3

    )

    Net cash provided by financing activities

     

     

    241

     

     

     

    7,695

     

     

     

     

     

     

    Net increase (decrease) in cash and cash equivalents

     

     

    (5,181

    )

     

     

    1,072

     

    Cash and cash equivalents at beginning of period

     

     

    7,409

     

     

     

    3,883

     

    Cash and cash equivalents at end of period

     

    $

    2,228

     

     

    $

    4,955

     

     

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  3. REDWOOD CITY, Calif., Aug. 11, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today provided an update on recent corporate developments and reported financial results for the three and six months ended June 30, 2021.

    Recent Corporate Developments

    • Completed six-month extended observation period of ALTISSIMO Phase 2b trial in wet AMD— 28 of the 50 patients who completed their Month 12 visit were eligible and agreed to continue masked clinical monitoring until the point at which they required additional supportive therapy, up to a maximum of six months. 25 of those patients completed…

    REDWOOD CITY, Calif., Aug. 11, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today provided an update on recent corporate developments and reported financial results for the three and six months ended June 30, 2021.

    Recent Corporate Developments

    • Completed six-month extended observation period of ALTISSIMO Phase 2b trial in wet AMD— 28 of the 50 patients who completed their Month 12 visit were eligible and agreed to continue masked clinical monitoring until the point at which they required additional supportive therapy, up to a maximum of six months. 25 of those patients completed their first visit at Month 13.  In June 2021, the last patient exited the extension period, with 60% of GB-102 1 mg patients requiring no supportive therapy during the six-month extension period.
    • Seeking partner for funding of additional wet AMD clinical trials— Enhanced formulations of GB-102 are being developed to further reduce or eliminate microparticle dispersion, and pre-clinical development is progressing in parallel.
    • Pursuing expansion of pipeline with focus on early-stage novel therapeutics addressing unmet needs— In-licensing efforts targeted at capital-efficient development opportunities are expected to both leverage and expand current platform technologies.

    Anticipated Milestones

    • Provide topline data analysis of ALTISSIMO six-month extended observation period in September 2021.
    • Present 12-month ALTISSIMO Phase 2b clinical trial data at the American Academy of Ophthalmology (AAO) meeting, November 12-15, 2021.

    Financial Results for the Three Months Ended June 30, 2021

    Net loss for the quarter ended June 30, 2021 was $7.7 million, compared to $5.9 million for the same period in 2020.

    Research and development expense for the quarter ended June 30, 2021 was $4.2 million, compared to $4.6 million for the same period in 2020. The decrease was primarily due to a reduction in clinical trial expenses due to the completion of the treatment phase of the GB-102 Phase 2b clinical trial in December 2020, offset in part by an increase in compensation costs.

    General and administrative expense for the quarter ended June 30, 2021 was $3.6 million, compared to $1.4 million for the same period in 2020. The increase in 2021 was primarily due to a $0.8 million increase in stock-based compensation, a $0.6 million increase in the cost of directors and officers insurance as a result of becoming a public company, and an increase in headcount.

    Financial Results for the Six Months Ended June 30, 2021

    Net loss for the six months June 30, 2021 was $19.2 million, compared to $13.7 million for the same period in 2020.

    Research and development expense for the six months ended June 30, 2021 was $10.6 million, compared to $10.7 million for the same period in 2020. While there was little overall change in research and development expenses, clinical trial expenses decreased in 2021 due to the completion of the treatment phase of the GB-102 Phase 2b clinical trial in December 2020, which was largely offset by fees incurred upon the cancellation of clinical supply orders for the GB-102 Phase 3 clinical trial and an increase in compensation costs.

    General and administrative expense for the six months ended June 30, 2021 was $8.6 million, compared to $3.1 million for the same period in 2020. The increase in 2021 was primarily due to a $1.5 million increase in stock-based compensation, a $1.3 million increase in the cost of directors and officers insurance as a result of becoming a public company, a $1.3 million write-off of deposits on fixed assets purchase commitments, and an increase in headcount.

    As of June 30, 2021, the company's cash and cash equivalents, and short-term and long-term investments totaled $78.2 million. Management believes the company's current cash and investments are sufficient to support its currently planned operations into 2023.

    About Graybug

    Graybug is a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve. The company's proprietary ocular delivery technologies are designed to maintain effective drug levels in ocular tissue for six months and potentially longer, improving disease management, reducing healthcare burdens and ultimately delivering better clinical outcomes. Graybug's lead product candidate, GB-102, a formulation of the pan-vascular endothelial growth factor (VEGF) inhibitor, sunitinib malate targeting a six-month or longer dosing regimen, inhibits multiple neovascular pathways for the intravitreal treatment of retinal diseases, including wet age-related macular degeneration. Graybug's other product candidates developed using its proprietary technologies also include GB-401, an injectable sustained-release formulation of a beta-adrenergic blocker prodrug, for primary open-angle glaucoma, with a dosing regimen of once every six months or longer, and GB-103, a longer-acting version of GB-102, designed to maintain therapeutic drug levels in the retinal tissue for 12 months with a single injection. Founded in 2011 on the basis of technology licensed from the Johns Hopkins University School of Medicine, Graybug is headquartered in Redwood City, California. For more information, please visit www.graybug.vision.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 including, but not limited to, statements regarding the company's clinical pipeline, its ability to timely identify a partner to fund further development of GB-102 for wet AMD on reasonable terms if at all, its ability to successfully execute one or more other licensing arrangements, the timing or outcomes of its interactions with regulatory authorities, its ability to advance GB-102, GB-103, GB-401, or any future product candidate through preclinical or clinical development, its ability to achieve its anticipated milestones within the timing outlined above or at all, its ability to conduct planned operations within the evolving constraints arising from the COVID-19 pandemic, the company's operating results and use of cash, the company's operations as a public company, the company's management and board of directors, and the timing, cost, and results of its clinical trials. Forward-looking statements are subject to risks and uncertainties that may cause the company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties described under the heading "Risk Factors" in the company's annual report on Form 10-K filed for the year ended December 31, 2020, in its subsequent quarterly reports on Form 10-Q, and in the other reports the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

    Investor Contact

    Media Contact

    IR@graybug.vision media@graybug.vision 
    (650) 487-2409(404) 384-0067

    GRAYBUG VISION, INC.

    Condensed Statements of Operations

    (In thousands, except share and per share amounts)

      Three Months Ended June 30,  Six Months Ended June 30, 
      2021  2020  2021  2020 
    Operating expenses:                
    Research and development $4,166  $4,632  $10,614  $10,717 
    General and administrative  3,575   1,408   8,615   3,119 
    Total operating expenses  7,741   6,040   19,229   13,836 
    Loss from operations  (7,741)  (6,040)  (19,229)  (13,836)
    Interest income  33   9   72   117 
    Change in fair value of preferred stock tranche obligation     162      56 
    Net loss  (7,708)  (5,869)  (19,157)  (13,663)
    Cumulative dividends on convertible preferred stock     (3,494)     (4,793)
    Net loss attributable to common stockholders $(7,708) $(9,363) $(19,157) $(18,456)
    Net loss per common share—basic and diluted $(0.36) $(6.79) $(0.91) $(13.40)
    Weighted-average number of shares outstanding used in computing net loss per common share—basic and diluted  21,148,743   1,379,644   21,084,915   1,377,431 
                     

    GRAYBUG VISION, INC.

    Condensed Balance Sheets

    (In thousands)

      June 30,

    2021
      December 31,

    2020

    (audited)
     
    Assets        
    Current assets:        
    Cash and cash equivalents $7,864  $33,418 
    Short-term investments  65,722   61,615 
    Prepaid expenses and other current assets  2,465   4,207 
    Total current assets  76,051   99,240 
    Property and equipment, net  2,006   1,946 
    Prepaid expenses and other non-current assets  136   608 
    Long-term investments  4,628    
    Total assets $82,821  $101,794 
    Liabilities and Stockholders' Equity        
    Current liabilities:        
    Accounts payable $2,101  $2,513 
    Accrued research and development  396   1,356 
    Other current liabilities  1,644   3,128 
    Total current liabilities  4,141   6,997 
    Deferred rent, long term portion  13   11 
    Total liabilities  4,154   7,008 
    Commitments and contingencies        
    Stockholders' Equity:        
    Preferred stock      
    Common stock  2   2 
    Additional paid-in capital  231,183   228,155 
    Accumulated deficit  (152,524)  (133,367)
    Accumulated other comprehensive loss  6   (4)
    Total stockholders' equity  78,667   94,786 
    Total liabilities and stockholders' equity $82,821  $101,794 
             


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