• 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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  1. 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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  2. REDWOOD CITY, Calif., Aug. 04, 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 a panel discussion titled "Goldeneye" at the Wedbush PacGrow Healthcare Conference on Wednesday, August 11, 2021 at 9:45 a.m. ET / 6:45 a.m. PT.

    A live webcast of the panel will be available in the Investors and Media section of the company's website at https://investors.graybug.vision/news-events/events-presentations. Following the live webcast, a replay will be available at the same location for…

    REDWOOD CITY, Calif., Aug. 04, 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 a panel discussion titled "Goldeneye" at the Wedbush PacGrow Healthcare Conference on Wednesday, August 11, 2021 at 9:45 a.m. ET / 6:45 a.m. PT.

    A live webcast of the panel will be available in the Investors and Media section of the company's website at https://investors.graybug.vision/news-events/events-presentations. Following the live webcast, a replay will be available at the same location for 14 days.  

    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.

    Investor Contact

    IR@graybug.vision

    (650) 487-2409

    Media Contact

    media@graybug.vision

    (404) 384-0067



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  3. Amy Burroughs and Dr. Charles Semba Bring Extensive and Complementary Experience in Building Specialty Therapeutics Companies

    DiaMedica Therapeutics Inc. (NASDAQ:DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, announced today the election of two industry veterans to the Company's Board of Directors. Amy Burroughs, President and CEO of Cleave Therapeutics, brings over 20 years of experience in business and commercial development, strategy and leadership in the pharmaceutical industry. Dr. Charles Semba, Chief Medical Officer of Eluminex Biosciences, has over 20 years of drug-development experience in high growth public and private therapeutics companies…

    Amy Burroughs and Dr. Charles Semba Bring Extensive and Complementary Experience in Building Specialty Therapeutics Companies

    DiaMedica Therapeutics Inc. (NASDAQ:DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, announced today the election of two industry veterans to the Company's Board of Directors. Amy Burroughs, President and CEO of Cleave Therapeutics, brings over 20 years of experience in business and commercial development, strategy and leadership in the pharmaceutical industry. Dr. Charles Semba, Chief Medical Officer of Eluminex Biosciences, has over 20 years of drug-development experience in high growth public and private therapeutics companies and serves on the faculty of Vascular/Interventional Radiology at Stanford University.

    "Amy and Charles have the perfect mix of experience to bring to our board at this stage of the company," said Rick Pauls, President and Chief Executive Officer of DiaMedica. "Their strategic, clinical and commercial insights will add significant value as we advance the development of DM199 to pivotal trials and expand our management team."

    Amy Burroughs

    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). Ms. Burroughs' career also includes consulting with Egon Zehnder in leadership development, talent and corporate governance for life sciences companies. 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. Ms. Burroughs holds a BA degree in computer science and economics from Dartmouth and an MBA from Harvard University.

    Charles Semba, MD

    Dr. Charles Semba 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®), the first global blockbuster anti-VEGF agent to reverse blindness in wet age-related macular degeneration and lifitegrast (XIIDRA®), the first novel agent for the treatment of both signs and symptoms of dry eye disease; XIIDRA was acquired by Novartis for over $5 billion (USD). He also led FDA approval for CathFlo Activase® (Alteplase). Dr. Semba holds an MD from University of Minnesota and is an Adjunct Professor of Vascular/Interventional Radiology at Stanford University.

    About DiaMedica Therapeutics

    DiaMedica Therapeutics is a clinical stage biopharmaceutical company committed to improving the lives of people suffering serious diseases. Our 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). Based on promising early clinical results, we are advancing DM199 in our REMEDY Phase 2/3 trial in the treatment of AIS and completing enrollment in our REDUX Phase 2 trial for the treatment of certain rare and significant unmet causes of CKD. For more information visit our website at www.diamedica.com.

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  4. REDWOOD CITY, Calif., May 12, 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 quarter ended March 31, 2021.

    Recent Corporate Developments

    • Full-data analysis from 12-month treatment phase of ALTISSIMO Phase 2b trial in wet AMD— GB-102 1mg has shown competitive durability and anatomical control versus aflibercept; trend in mean BCVA of GB-102 1mg compared to aflibercept driven primarily by a subgroup of patients.
    • Six-month observational trial extension of ALTISSIMO still underway— 14…

    REDWOOD CITY, Calif., May 12, 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 quarter ended March 31, 2021.

    Recent Corporate Developments

    • Full-data analysis from 12-month treatment phase of ALTISSIMO Phase 2b trial in wet AMD— GB-102 1mg has shown competitive durability and anatomical control versus aflibercept; trend in mean BCVA of GB-102 1mg compared to aflibercept driven primarily by a subgroup of patients.
    • Six-month observational trial extension of ALTISSIMO still underway— 14 of 28 patients enrolled have completed at least five months of the extension period without requiring additional supportive therapy, with six of those having completed all six months. 
    • Seeking partner for funding of additional wet AMD clinical trials— Enhanced formulations of GB-102 being developed and preclinical work progressing in parallel.

    • Clinical focus shifting to advancement of GB-401 implant for glaucoma— Disclosed development of implant technology for GB-401 with potential application to GB-102.

    Anticipated Milestones

    • Complete six-month observational trial extension of ALTISSIMO by June 2021, with topline data expected in 3Q 2021.
    • Expected to present full results of ALTISSIMO trial at a medical conference in 4Q 2021.
    • Submit Investigational New Drug (IND) application for GB-401, an injectable formulation of a beta-adrenergic blocker prodrug, for primary open-angle glaucoma, with a dosing regimen of once every six months or longer, in the first half of 2022.
    • Commence a Phase 1 trial for GB-401 implant in glaucoma in the first half of 2022.

    First Quarter 2021 Financial Results

    Net loss for the quarter ended March 31, 2021 was $11.4 million compared to $7.8 million for the same period in 2020.

    Research and development expense for the quarter ended March 31, 2021 was $6.4 million compared to $6.1 million for the same period in 2020. The increase was primarily due to fees incurred upon the cancellation of clinical supply orders for the GB-102 Phase 3 trial and increased compensation costs, offset in part by a reduction in clinical trial expenses due to the completion of the treatment phase of the ALTISSIMO trial in December 2020.

    General and administrative expense for the quarter ended March 31, 2021 was $5.0 million compared to $1.7 million for the same period in 2020. The increase in 2021 was primarily due to the write-off of deposits on fixed assets purchase commitments, an increase in stock-based compensation and an increase in headcount, and the increased cost of additional directors and officers insurance as a result of becoming a public company.

    As of March 31, 2021, the company's cash, cash equivalents, and short-term investments totaled $85.7 million, compared to $95.0 million as of December 31, 2020. The decrease was primarily due to the loss from operations of $11.5 million. The company's current cash and investments are sufficient to support its currently planned operations into the first half of 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 identify a partner to advance the development of GB-102 for wet AMD, 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 timely secure a partner to fund further development of GB-102 on reasonable terms if at all, 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, and 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

    GRAYBUG VISION, INC.

    Condensed Statements of Operations

    (In thousands, except share and per share amounts; unaudited)

      Three Months Ended March 31, 
      2021   2020  
    Operating expenses:        
    Research and development $6,448   $6,085  
    General and administrative  5,040    1,711  
    Total operating expenses  11,488    7,796  
    Loss from operations  (11,488)   (7,796) 
    Interest income  39    108  
    Change in fair value of preferred stock tranche obligation      (106) 
    Net loss  (11,449)   (7,794) 
    Cumulative dividends on convertible preferred stock      (1,299) 
    Net loss attributable to common stockholders $(11,449)  $(9,093) 
    Net loss per common share—basic and diluted $(0.54)  $(6.61) 
    Weighted-average number of shares outstanding used in computing net loss per common share—basic and diluted  21,020,378    1,375,177  



    GRAYBUG VISION, INC.


    Condensed Balance Sheets

    (In thousands)

     March 31,   December 31, 
     2021   2020  
      (unaudited)   (audited) 
    Assets       
    Current assets:       
    Cash and cash equivalents$10,589   $33,418  
    Short-term investments 75,099    61,615  
    Prepaid expenses and other current assets 3,133    4,207  
    Total current assets 88,821    99,240  
    Property and equipment, net 2,002    1,946  
    Prepaid expenses and other non-current assets 29    608  
    Total assets$90,852   $101,794  
    Liabilities, Convertible Preferred Stock and Stockholders' Equity       
    Current liabilities:       
    Accounts payable$1,956   $2,513  
    Accrued research and development 2,097    1,356  
    Other current liabilities 2,225    3,128  
    Total current liabilities 6,278    6,997  
    Deferred rent, long term portion 12    11  
    Total liabilities 6,290    7,008  
    Commitments and contingencies       
    Convertible preferred stock       
    Stockholders' Equity:       
    Preferred stock       
    Common stock 2    2  
    Additional paid-in capital 229,376    228,155  
    Accumulated deficit (144,816)   (133,367) 
    Accumulated other comprehensive loss     (4) 
    Total stockholders' equity 84,562    94,786  
    Total liabilities, convertible preferred stock and stockholders' equity$90,852   $101,794  

     



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    • GB-102 1mg has shown competitive durability and anatomical control versus aflibercept
    • Trend in mean BCVA of GB-102 1mg compared to aflibercept driven primarily by a subgroup of patients
    • Developing enhanced formulations and seeking partner funding for additional clinical trials of GB-102
    • Focus on advancing GB-401 implant for glaucoma
    • Current cash sufficient to support planned operations into 2023

    Management to host webcast/conference call today at 8 a.m. ET

    REDWOOD CITY, Calif., May 12, 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 12-month…

    • GB-102 1mg has shown competitive durability and anatomical control versus aflibercept
    • Trend in mean BCVA of GB-102 1mg compared to aflibercept driven primarily by a subgroup of patients
    • Developing enhanced formulations and seeking partner funding for additional clinical trials of GB-102
    • Focus on advancing GB-401 implant for glaucoma
    • Current cash sufficient to support planned operations into 2023

    Management to host webcast/conference call today at 8 a.m. ET

    REDWOOD CITY, Calif., May 12, 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 12-month treatment phase of its 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 is a masked and controlled Phase 2b dose-ranging study of two doses of GB-102 with a single control arm of patients on aflibercept, conducted across 33 study sites in the United States. The primary endpoint is median time to first supportive therapy with a vascular endothelial growth factor (VEGF) inhibitor, and secondary endpoints are safety and pharmacodynamics, measured as mean change of best-corrected visual acuity (BCVA) and mean change of central subfield thickness (CST) of the retina.

    The ALTISSIMO full-data analysis focused on the GB-102 1mg arm as compared to aflibercept and the pre-enrollment period, excluding results from the GB-102 2mg arm. As previously reported, the development of GB-102 2mg was terminated in 2020 following an interim safety analysis. The trial was not powered to assess non-inferiority to aflibercept.

    Overall, GB-102 1mg was safe and well-tolerated. No drug-related serious adverse events or vision-threatening inflammation were reported. The majority of drug-related adverse events were mild to moderate. Particle migration to the anterior chamber in patients treated with GB-102 1mg was reduced by 79% as compared to GB-102 1mg patients in the ADAGIO Phase 1/2a trial (4/51 injections vs. 3/8), and no surgical interventions were required.

    As previously reported, patients in the GB-102 1mg trial arm (n=21) had a median time to first supportive therapy of five months, and 48% of patients did not require supportive therapy for at least six months. An additional analysis showed the injection frequency was reduced by 58% compared to patients' treatment prior to enrollment in the trial.

    "Given the constantly changing landscape of long-acting drug delivery, GB-102 has the potential to significantly reduce the treatment burden for patients compared to the current standard of care," said Parisa Zamiri, MD, PhD, Chief Medical Officer of Graybug. "The ALTISSIMO results support further exploration of enhanced formulations of GB-102 for the treatment of wet AMD."

    Although ALTISSIMO was not powered to show statistical significance, control of CST in patients treated with twice-a-year GB-102 1mg compared with baseline was similar to bi-monthly aflibercept, while BCVA trended lower in GB-102 1mg patients as compared with aflibercept. This trend in visual acuity was primarily driven by six patients: two patients whose disease was not well-controlled despite frequent anti-VEGF treatment prior to enrollment, two patients who experienced adverse events unrelated to GB-102, and two patients who experienced adverse events related to dispersion of GB-102 microparticles.

    Over the past 18 months, Graybug continued to optimize its technology platform and initiated the development of additional formulations, which have the potential to preserve the durability of GB-102 microparticles while minimizing the risk of dispersion. These new and enhanced formulations, including injectable implants, also have the potential to simplify the drug reconstitution process as well as minimize the injection technique variability. They 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 first half of 2022.

    "We are encouraged by the ALTISSIMO full-data analysis that indicates favorable safety, extended durability, and pharmacodynamics of GB-102, and are in the process of designing an additional trial in wet AMD with enhanced formulations of GB-102 while looking for a partner to fund its further clinical development," said Fred Guerard, PharmD, Chief Executive Officer, Graybug Vision. "We will pause development of GB-103 and GB-102 for diabetic macular edema while we devote our current cash to advancing GB-401 through Phase 1 clinical development. Our opportunistic in-licensing efforts will continue targeting technologies addressing high unmet medical needs in ophthalmology."

    Graybug expects to report the results from the on-going six-month extension period of ALTISSIMO in the fourth quarter of 2021.

    Conference Call and Webcast

    Graybug's management will host a webcast and conference call at 8 a.m. ET / 5 a.m. PT today, May 12, 2021, to discuss the ALTISSIMO clinical results. The live call may be accessed by dialing (844) 955-2748 (domestic) and (929) 517-0407 (international) and entering the conference ID# 5461708 or via webcast from the IR Events & Presentations page of the Investors and Media section of Graybug's website at https://investors.graybug.vision/news-events/events-presentations. Following the live event, a replay will be available at the same location.

    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 identify a partner to advance the development of GB-102 for wet AMD, 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 timely secure a partner to fund further development of GB-102 on reasonable terms if at all, 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 for the year ended December 31, 2020, and 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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  5. REDWOOD CITY, Calif., May 05, 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 it will host a conference call and webcast to discuss the full-data analysis of the 12-month treatment phase of its Phase 2b ALTISSIMO trial on Wednesday, May 12, 2021 at 8 a.m. Eastern time (5 a.m. Pacific time).

    The event will be available live by dialing (844) 955-2748 (domestic) and (929) 517-0407 (international) and entering the conference ID# 5461708 or via webcast from the IR Events & Presentations page of the Investors and Media section of Graybug's website at https://investors.graybug.vision/news-events/events-presentations

    REDWOOD CITY, Calif., May 05, 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 it will host a conference call and webcast to discuss the full-data analysis of the 12-month treatment phase of its Phase 2b ALTISSIMO trial on Wednesday, May 12, 2021 at 8 a.m. Eastern time (5 a.m. Pacific time).

    The event will be available live by dialing (844) 955-2748 (domestic) and (929) 517-0407 (international) and entering the conference ID# 5461708 or via webcast from the IR Events & Presentations page of the Investors and Media section of Graybug's website at https://investors.graybug.vision/news-events/events-presentations. Following the live event, a replay will be available at the same location.

    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 microparticle depot 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 is also using its proprietary technologies to develop GB-401, an injectable depot 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 results of the Phase 2b ALTISSIMO trial, the company's clinical pipeline, interactions with regulatory authorities, its ability to advance GB-102, GB-103, GB-401, or any future product candidate through 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 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 most recent annual and quarterly reports, and 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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    • Median time to first supportive therapy was 5 months for GB-102 1mg
    • 48% of patients in the GB-102 1 mg arm were rescue-free for at least 6 months
    • Control of retinal thickness was consistent across all trial arms
    • Mean best-corrected visual acuity with GB-102 1mg trended lower than aflibercept arm
    • No drug-related serious adverse events
    • Clinical monitoring is ongoing to observe durability beyond 6 months

    REDWOOD CITY, Calif., March 09, 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 preliminary topline data from the 12-month treatment phase of its Phase 2b ALTISSIMO trial…

    • Median time to first supportive therapy was 5 months for GB-102 1mg

    • 48% of patients in the GB-102 1 mg arm were rescue-free for at least 6 months
    • Control of retinal thickness was consistent across all trial arms
    • Mean best-corrected visual acuity with GB-102 1mg trended lower than aflibercept arm
    • No drug-related serious adverse events
    • Clinical monitoring is ongoing to observe durability beyond 6 months

    REDWOOD CITY, Calif., March 09, 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 preliminary topline data from the 12-month treatment phase of its Phase 2b ALTISSIMO trial of GB-102 for the treatment of wet age-related macular degeneration (wet AMD), Graybug's proprietary microparticle depot formulation of sunitinib malate injected intravitreally.

    The ALTISSIMO trial is a masked and controlled Phase 2b dose-ranging study of two doses of GB-102 with a single control arm of patients on aflibercept, conducted across 33 study sites in the United States. The primary endpoint is median time to first supportive therapy with a vascular endothelial growth factor (VEGF) inhibitor, and secondary endpoints are pharmacodynamics measures of mean change of best-corrected visual acuity (BCVA) from baseline and mean change of central subfield thickness (CST) of the retina from baseline.

    The trial was originally designed to evaluate two separate doses of GB-102, 1mg and 2mg, injected every 6 months as compared with aflibercept injected every 2 months. Based on the results of an interim safety analysis, the 2mg dose was discontinued after the initial dose, and all patients in that arm were switched to 1mg for their second dose.

    Analysis of the ALTISSIMO 1mg arm shows the primary endpoint of median time to first supportive therapy was 5 months. Furthermore, 48% of patients did not require supportive therapy for at least 6 months, and 62% of patients for at least 4 months or more, at least once during the trial. Overall, the 1mg dose performed better than the 2mg dose.

    Overall, GB-102 1mg was well-tolerated. There were no drug-related serious adverse events, and the majority of drug-related adverse events were mild to moderate. Medication was detected in the anterior chamber in less than 10% of GB-102 1mg injections, and no adverse event required surgical intervention. There was no vision-threatening inflammation observed, and there was no increase in intraocular pressure reported.

    CST and BCVA were measured as secondary endpoints. CST in the GB-102 1mg arm was consistent with the study control arm. The mean change from baseline for BCVA for all 20 completers was approximately 9 letters lower across all time points, on average, than that observed in the study control arm.

    At the end of the treatment phase, patients were surveyed as to their satisfaction with their treatment compared to their treatment prior to entering the trial. Over 80% of responding patients who had been treated with GB-102 reported that they were equally or more satisfied with their treatment, similar to the satisfaction expressed by patients treated with aflibercept.

    ALTISSIMO is continuing through a six-month extension in which 28 of the 50 patients who completed their Month 12 visit were eligible and agreed to continue masked clinical monitoring. Patients will continue with monthly visits until the point at which they require additional supportive therapy, up to a maximum of 6 months. As of today, 22 patients have successfully completed 2 months or more of this six-month extension period without the need for further treatment.

    Graybug will determine next steps after completing the full analysis of the ALTISSIMO results, which is anticipated to occur in the second quarter.

    "We are very grateful to all patients, investigators and staff who participated in the ALTISSIMO trial, and look forward to the read-out of the extension trial data," said Parisa Zamiri, MD, PhD, Chief Medical Officer of Graybug.

    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 microparticle depot 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 is also using its proprietary technologies to develop GB-401, an injectable depot 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, interactions with regulatory authorities, its ability to advance GB-102, GB-103, GB-401, or any future product candidate through 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 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 for the year ended December 31, 2020, and 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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  6. REDWOOD CITY, Calif., March 04, 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 full year ended December 31, 2020.

    "We are very pleased with Graybug's achievements in 2020. Amidst a challenging pandemic, we completed our initial public offering and advanced our lead product candidate GB-102 in retinal disease through the treatment phase of its Phase 2b ALTISSIMO trial in wet age-related macular degeneration (wet AMD). I am excited to share that we are now on track to report topline…

    REDWOOD CITY, Calif., March 04, 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 full year ended December 31, 2020.

    "We are very pleased with Graybug's achievements in 2020. Amidst a challenging pandemic, we completed our initial public offering and advanced our lead product candidate GB-102 in retinal disease through the treatment phase of its Phase 2b ALTISSIMO trial in wet age-related macular degeneration (wet AMD). I am excited to share that we are now on track to report topline data from our ALTISSIMO trial by the end of this month," said Frederic Guerard, PharmD, Chief Executive Officer of Graybug.

    Recent Corporate Developments

    • Completion of 12-month treatment phase of ALTISSIMO trial in wet AMD — 50 patients out of the 56 initially enrolled completed the 12-month treatment phase of the three-arm, randomized, and masked trial of GB-102 in December 2020. Six patients did not complete the study for reasons unrelated to their treatments. Topline data for this 12-month treatment phase are expected to be announced in March 2021.
    • Initiation of 6-month observational trial extension of ALTISSIMO — 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 require additional supportive therapy, up to a maximum of six months. As of today, 22 patients have successfully completed two months or more of this six-month extension period without the need for further treatment.
    • Named Bettina Maunz as Chief People Officer — Ms. Maunz is building and leading the human resources function as a member of Graybug's executive team and serves as Head of Communications.

    Anticipated Milestones in 2021

    • Communicate topline data for the 12-month treatment phase of ALTISSIMO in March 2021, with full results to be presented at a medical conference expected in 3Q 2021.
    • Complete 6-month observational trial extension of ALTISSIMO by June 2021, with topline data expected in 3Q 2021.
    • Initiate two pivotal Phase 3 trials for GB-102 in patients with wet AMD in the second half of 2021.
    • Initiate Phase 2b trial for GB-102 in patients with diabetic macular edema (DME) in the second half of 2021.
    • Submit Investigational New Drug (IND) application for GB-401, an injectable depot formulation of a beta-adrenergic blocker prodrug, for primary open-angle glaucoma, with a dosing regimen of once every six months or longer, in the second half of 2021.
    • Commence a Phase 1 trial for GB-401 in the second half of 2021.

    Full Year 2020 Financial Results

    Net loss for 2020 was $27.5 million compared to $37.0 million for 2019. Net loss for 2020 included a non-cash gain of $2.2 million resulting from the modification and expiration of the liability related to the preferred stock tranche obligation that was permanently eliminated in connection with the company's initial public offering, or IPO, in September 2020. Excluding this gain, the 2020 net loss would have been $29.7 million.

    Research and development expense for 2020 was $21.0 million compared to $30.6 million for 2019. The decrease in 2020 was primarily due to the fact that the company did not engage in any primary manufacturing activities in 2020 compared with 2019, during which the company manufactured the clinical supplies for the ALTISSIMO clinical trial that commenced later in the third quarter of 2019.

    General and administrative expense for 2020 was $8.9 million compared to $6.9 million for 2019. The increase in 2020 was primarily due to additional professional services, related in part to preparing for and becoming a public company, and the related increased cost of additional D&O insurance.

    As of December 31, 2020, the company's cash, cash equivalents, and short-term investments totaled $95.0 million, compared to $36.0 million as of December 31, 2019. The increase was due to the receipt of $92.1 million in net proceeds from the company's IPO. The company's current cash and investments are sufficient to support its planned operations into the first quarter of 2022.

    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 microparticle depot 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 is also using its proprietary technologies to develop GB-401, an injectable depot 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 advance GB-102, GB-103, GB-401, or any future product candidate through 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 cash positions, the company's operations as a public company, the company's management and board of directors, and the timing 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 quarterly report on Form 10-Q for the three months ended September 30, 2020, its annual report on Form 10-K to be filed for the year ended December 31, 2020, and 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



    GRAYBUG VISION, INC.


    Condensed Statements of Operations

    (In thousands, except share and per share amounts)

    (2020 unaudited)

      Year Ended December 31, 
      2020  2019 
    Operating expenses:        
    Research and development $20,962  $30,580 
    General and administrative  8,870   6,922 
    Total operating expenses  29,832   37,502 
    Loss from operations  (29,832)  (37,502)
    Interest income  143   393 
    Change in fair value of preferred stock tranche obligation  2,158   72 
    Net loss  (27,531)  (37,037)
    Cumulative dividends on convertible preferred stock  (7,189)  (7,055)
    Net loss attributable to common stockholders $(34,720) $(44,092)
    Net loss per common share—basic and diluted $(5.25) $(33.41)
    Weighted-average number of shares outstanding used in computing net loss per common share—basic and diluted  6,618,445   1,319,912 





    GRAYBUG VISION, INC.


    Condensed Balance Sheets

    (In thousands)

    (2020 unaudited)

      December 31, 
      2020  2019 
    Assets        
    Current assets:        
    Cash and cash equivalents $33,418  $15,870 
    Short-term investments  61,615   20,086 
    Prepaid expenses and other current assets  4,207   315 
    Total current assets  99,240   36,271 
    Property and equipment, net  1,946   1,975 
    Prepaid expenses and other non-current assets  608   2,414 
    Total assets $101,794  $40,660 
    Liabilities, Convertible Preferred Stock and Stockholders' Equity (Deficit)        
    Current liabilities:        
    Accounts payable $2,513  $4,636 
    Accrued research and development  1,356   2,333 
    Other current liabilities  3,128   3,124 
    Preferred stock tranche obligation     2,158 
    Total current liabilities  6,997   12,251 
    Deferred rent, long term portion  11    
    Total liabilities  7,008   12,251 
    Commitments and contingencies        
    Convertible preferred stock     131,363 
    Stockholders' Equity (Deficit):        
    Preferred stock      
    Common stock  2    
    Additional paid-in capital  228,155   2,879 
    Accumulated deficit  (133,367)  (105,836)
    Accumulated other comprehensive (loss) income  (4)  3 
    Total stockholders' equity (deficit)  94,786   (102,954)
    Total liabilities, convertible preferred stock and stockholders' equity (deficit) $101,794  $40,660 



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  7. REDWOOD CITY, Calif., Feb. 17, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines to treat chronic vision-threatening diseases of the retina and optic nerve, today announced that Fred Guerard, PharmD, Chief Executive Officer of Graybug Vision, will participate in a fireside chat at the SVB Leerink 10th Annual Global Healthcare Conference on Wednesday, February 24, 2021 at 3:40 p.m. ET / 12:40 p.m. PT.

    A live webcast of the fireside chat will be available on the IR Events & Presentations page of the Investors and Media section of Graybug's website at https://investors.graybug.vision/news-events/events-presentations. Following the live webcast…

    REDWOOD CITY, Calif., Feb. 17, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines to treat chronic vision-threatening diseases of the retina and optic nerve, today announced that Fred Guerard, PharmD, Chief Executive Officer of Graybug Vision, will participate in a fireside chat at the SVB Leerink 10th Annual Global Healthcare Conference on Wednesday, February 24, 2021 at 3:40 p.m. ET / 12:40 p.m. PT.

    A live webcast of the fireside chat will be available on the IR Events & Presentations page of the Investors and Media section of Graybug's website at https://investors.graybug.vision/news-events/events-presentations. Following the live webcast, a replay will be available at the same location for 14 days.

    About Graybug Vision

    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 microparticle depot 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 is also using its proprietary technologies to develop GB-401, an injectable depot 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.

    Investor Contact

    IR@graybug.vision

    (650) 487-2409



    Media Contact

    media@graybug.vision

    (404) 384-0067





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  8. REDWOOD CITY, Calif., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines to treat chronic vision-threatening diseases of the retina and optic nerve, today announced the appointment of Bettina Maunz as Chief People Officer. In addition to building and leading the human resources function for Graybug Vision, Ms. Maunz will serve as Head of Communications and be a member of the company's executive team.

    "We are delighted for Bettina to join Graybug as Chief People Officer. Her leadership, culture and communications experience will be important assets to our team," said Frederic Guerard, PharmD, Chief Executive Officer of Graybug Vision…

    REDWOOD CITY, Calif., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines to treat chronic vision-threatening diseases of the retina and optic nerve, today announced the appointment of Bettina Maunz as Chief People Officer. In addition to building and leading the human resources function for Graybug Vision, Ms. Maunz will serve as Head of Communications and be a member of the company's executive team.

    "We are delighted for Bettina to join Graybug as Chief People Officer. Her leadership, culture and communications experience will be important assets to our team," said Frederic Guerard, PharmD, Chief Executive Officer of Graybug Vision. "Her passion for building high-performing teams and driving employee engagement will be a strong contributor to our future success."

    "I am excited to be joining Graybug as its first Chief People Officer," stated Bettina Maunz. "I believe the company is at an inflection point and I look forward to partnering with the executive team in shaping Graybug's culture as well as attracting and retaining the right talent to fully leverage Graybug's potential."

    Bettina has served as a consultant to Graybug since August 2019 and played an integral role in the planning and successful execution of the company's IPO in September 2020. Prior to Graybug, Bettina held the position of VP, Group Head of Enterprise Communications at Novartis, where she led the development and implementation of the enterprise communications strategy with a focus on driving company-wide culture change in partnership with the executive team and human resources department. Prior to that, Bettina served as VP, Global Head of Communications at Alcon and was President of the Alcon Foundation. During her tenure, she established the Global Communications function, played a key role in the company's culture and business transformation, as well as defined and executed Alcon's corporate social responsibility strategy partnering with leading non-profit organizations to enhance access to quality eye care in developing markets as well as local communities. Bettina also served in leadership positions at CIBA Vision, Novartis Pharma and Serono International earlier in her career.

    About Graybug Vision

    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 microparticle depot 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 is also using its proprietary technologies to develop GB-401, an injectable depot 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.

    Investor Contact

    IR@graybug.vision

    (650) 487-2409



    Media Contact

    media@graybug.vision

    (404) 384-0067





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  9. REDWOOD CITY, Calif., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines to treat chronic vision-threatening diseases of the retina and optic nerve, today announced the last patient visit in its GB-102 Phase 2b ALTISSIMO core trial (the 12-month treatment phase) in wet age-related macular degeneration (wet AMD). ALTISSIMO 12-month topline data are expected to be announced in the second quarter of 2021, with full results to be presented at a medical conference later in the year.

    Of the 56 patients enrolled in ALTISSIMO, 50 patients completed the 12-month treatment phase, while the remaining six patients withdrew for reasons unrelated…

    REDWOOD CITY, Calif., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines to treat chronic vision-threatening diseases of the retina and optic nerve, today announced the last patient visit in its GB-102 Phase 2b ALTISSIMO core trial (the 12-month treatment phase) in wet age-related macular degeneration (wet AMD). ALTISSIMO 12-month topline data are expected to be announced in the second quarter of 2021, with full results to be presented at a medical conference later in the year.

    Of the 56 patients enrolled in ALTISSIMO, 50 patients completed the 12-month treatment phase, while the remaining six patients withdrew for reasons unrelated to their treatment. Furthermore, 58 percent of patients who completed their Month 12 visit were eligible and agreed to continue clinical monitoring in a six-month extension of the trial. The goal of this six-month extension period is to observe further durability of GB-102 in wet AMD patients.

    "We are pleased with the completion of treatment in ALTISSIMO which is expected to provide important data regarding the duration of treatment, safety and tolerability of GB-102 in wet AMD," said Parisa Zamiri, MD, PhD, Chief Medical Officer of Graybug Vision. "Wet AMD is a leading cause of vision loss among the elderly with outcomes adversely affected by the high treatment burden of approved medications which need to be injected up to 12 times per year. The findings of this trial, designed to measure the durability of a twice-per-year dosing, may potentially demonstrate the need for fewer treatments per year, and we look forward to sharing the topline results in the second quarter of 2021."

    Graybug's lead product candidate, GB-102, is a proprietary microparticle depot formulation of the pan-vascular endothelial growth factor (pan-VEGF) inhibitor, sunitinib malate, designed to be administered intravitreally twice per year. GB-102 seeks to reduce the need for frequent intravitreal injections by expanding treatment duration to six months, and potentially longer, thus reducing the burden of current anti-VEGF treatments which require up to 12 injections per year.

    About GB-102 Phase 2b Clinical Trial in Wet AMD (ALTISSIMO)

    ALTISSIMO comprises a 12-month, multicenter, prospective, masked, randomized trial comparing GB-102 administered every six months to aflibercept administered every two months in patients with anti-VEGF-responsive wet AMD, followed by an additional six-month observational period. The objective of the ALTISSIMO Phase 2b core trial is to assess the safety, tolerability, and pharmacodynamic profile of GB-102. The findings will inform the design of Graybug's pivotal Phase 3 clinical trial program in wet AMD expected to initiate in the second half of 2021.

    About Wet AMD

    Wet AMD is one of the most common retinal diseases, leading to vision decline caused by excess VEGF. VEGF is a protein produced by cells that stimulates the formation of abnormal new blood vessels behind the retina, called choroidal neovascularization. The leakage of fluid and protein from the vessels causes retinal degeneration and leads to severe and rapid loss of vision. Early intervention is essential to treat wet AMD. The prevalence of wet AMD in the United States is estimated at 1.5 million people and approximately 25 million people are affected by wet AMD worldwide.

    About Graybug Vision

    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 microparticle depot 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 is also using its proprietary technologies to develop GB-401, an injectable depot 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 advance GB-102, GB-103, GB-401, or any future product candidate through clinical development, its ability to achieve its anticipated milestones, including the completion of the ALTISSIMO trial, 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 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 quarterly report on Form 10-Q for the three months ended September 30, 2020, and 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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    • Proceeds to fund development of novel and best-in-class therapeutics for eye diseases
    • Charles Semba, MD, joins the company to serve as Chief Medical Officer

    SHANGHAI, Nov. 27, 2020 /PRNewswire/ -- Eluminex Biosciences Limited (Eluminex), an ophthalmic biotechnology company committed to the discovery and development of first-in-class and/or best-in-class therapies, today announced the completion of a $50 million (USD) Series A Financing co-led by Lilly Asia Ventures, GL Ventures (venture capital arm of Hillhouse Capital), and Quan Capital. The Eluminex headquarters and research and development center are located in Suzhou Industrial Park; the business center is based in Shanghai, and future plans include establishing a global clinical and registration…

    • Proceeds to fund development of novel and best-in-class therapeutics for eye diseases
    • Charles Semba, MD, joins the company to serve as Chief Medical Officer

    SHANGHAI, Nov. 27, 2020 /PRNewswire/ -- Eluminex Biosciences Limited (Eluminex), an ophthalmic biotechnology company committed to the discovery and development of first-in-class and/or best-in-class therapies, today announced the completion of a $50 million (USD) Series A Financing co-led by Lilly Asia Ventures, GL Ventures (venture capital arm of Hillhouse Capital), and Quan Capital. The Eluminex headquarters and research and development center are located in Suzhou Industrial Park; the business center is based in Shanghai, and future plans include establishing a global clinical and registration center in the San Francisco Bay Area.

    "We greatly appreciate the profound level of support and trust from three global investors," said Jinzhong Zhang, PhD, Co-Founder, Chairman, and Chief Executive Officer. "With these proceeds, our goal is to build an innovative pipeline addressing critical unmet medical needs in vision-threatening diseases for patients worldwide. Additionally, we are pleased to have three world-renowned professors of ophthalmology as members of our Scientific Advisory Board: Quan Dong Nguyen, MD, MSc (Stanford University), Zuguo Liu, MD, PhD (Xiamen University), and Xiaodong Sun, MD, PhD (Shanghai Jiao Tong University). We are grateful for their significant contributions in helping us develop our pipeline programs."

    The company also announced that Charles Semba, MD, has joined Eluminex as Chief Medical Officer (CMO). Dr. Semba is an internationally recognized leader in ophthalmic drug development. He has served as CMO in three prior ophthalmic companies: 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®), the first global blockbuster anti-VEGF agent to reverse blindness in wet age-related macular degeneration and lifitegrast (XIIDRA®), the first novel agent for the treatment of both signs and symptoms of dry eye disease; XIIDRA® was acquired by Novartis for over $5 billion (USD).

    Regarding the success of this financing, all parties have expressed their confidence and expectations for the new company. "Closing Series A financing is indeed a major milestone. The leadership at Eluminex should be congratulated for this impressive achievement amidst current global events," commented Dr. Nguyen, Professor of Ophthalmology at the Byers Eye Institute, Stanford University. "Such financial success and security demonstrate the trusts that the company has earned from the investment community in Eluminex's research and development therapeutic plans to preserve and enhance vision for patients with devastating ocular diseases worldwide."

    "Driven by an aging population and overuse of eyes in various ages, the ophthalmic market is seeing huge unmet needs for new products. The team's solid track record and rich experience in ophthalmic drug development enables the company to develop innovative therapies not only for China but also for the global market. We are thrilled and honored to join hands with this seasoned team and partner with the reputable investors from the very beginning," said Stephen Lin, Partner at Lilly Asia Ventures.

    "The founding team of Eluminex Biosciences has rich experience in drug development and innovation with great potential in the future. Hillhouse will help Eluminex continue to innovate, research and develop leading ophthalmic disease treatment drugs, meeting the needs of a large number of patients, and continue to create social well-being," said Michael Yi, Partner and Co-Chief Investment Officer of Hillhouse Capital Group.

    "Quan Capital is committed to foster innovation and bring new solutions to patients with great unmet needs. We are pleased to co-lead the Series A round of Eluminex and are truly impressed by the stellar management team," said Marietta Wu, Managing Director of Quan Capital. "We believe this team of seasoned industry veterans both globally and in China will build a leader in ophthalmology with accelerated development of novel therapeutics. Quan looks forward to working closely with the team and contributing our local resources and global networks."

    About Eluminex Biosciences

    Eluminex was established in February 2020 with the commitment to leading the development of novel therapeutics for the benefit of patients with vision-threatening eye diseases worldwide. Co-Founders, Dr. Jinzhong Zhang and Dr. Zhenze John Hu, have assembled a top tier management team with significant ophthalmic drug development experience, aiming to build a robust and sustainable innovative ophthalmic pipeline to tackle the unmet clinical needs. For detailed information contact Zhenze John Hu at john.hu@eluminexbio.com

    About Lilly Ventures Asia

    Lilly Asia Ventures (LAV) is a leading biomedical venture capital firm founded in 2008, with offices in Shanghai, Hong Kong, and Menlo Park. LAV's vision is to become the trusted partner for exceptional entrepreneurs seeking smart capital and to build great companies developing breakthrough products that can treat diseases and improve human health. For more information, visit www.lillyasiaventures.com.   

    About GL Ventures

    GL Ventures focuses on early-stage innovative companies in healthcare, software services, consumer Internet, emerging consumer brands and services. The GL Ventures team is passionate about partnering with visionary entrepreneurs to create industry leaders that stand the test of time. GL Ventures is the early stage affiliate of Hillhouse Capital, and we have been investing with innovators across the world since 2005. We were one of the earliest investors into some of the largest global companies today, including BeiGene, Zoom, Meituan, JD, Woowa Brothers and many more.

    About Quan Capital

    Quan Capital (Quan) is a life sciences venture capital firm with strong China expertise and global capabilities. Quan discovers, incubates, and grows next-generation life science companies in early and growth stage, worldwide. Their portfolio companies pioneer differentiated therapies and enabling technologies to address major human diseases with high unmet medical needs. With offices in Shanghai, Palo Alto and Boston, Quan's investment professionals combine their strong expertise in both science and business with their diverse experiences in global drug development and healthcare investments, and leverage their broad network worldwide to help maximize the company's value across geographies and development stages. For more information, visit www.quancapital.com.

    Cision View original content:http://www.prnewswire.com/news-releases/eluminex-biosciences-an-ophthalmology-focused-biotechnology-company-announces-closing-of-50-million-series-a-financing-301181102.html

    SOURCE Eluminex Biosciences

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  10. REDWOOD CITY, Calif., Nov. 16, 2020 (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 a fireside chat in advance of the virtual Piper Sandler Healthcare Conference, being held December 1-3, 2020.

    A recording of the fireside chat will be accessible beginning November 23, 2020 by visiting IR Events & Presentations in the Investors and Media section of the company's website at https://investors.graybug.vision/news-events/events-presentations. The recording will be available on the Graybug…

    REDWOOD CITY, Calif., Nov. 16, 2020 (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 a fireside chat in advance of the virtual Piper Sandler Healthcare Conference, being held December 1-3, 2020.

    A recording of the fireside chat will be accessible beginning November 23, 2020 by visiting IR Events & Presentations in the Investors and Media section of the company's website at https://investors.graybug.vision/news-events/events-presentations. The recording will be available on the Graybug website for 14 days following the conference.

    About Graybug Vision

    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 microparticle depot 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 is also using its proprietary technologies to develop GB-401, an injectable depot 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.

    Investor Contact

    IR@graybug.vision

    (650) 487-2409



    Media Contact

    media@graybug.vision

    (404) 384-0067





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