TruckingAngler
2 years ago
So much for the supposed BS "vote". GRAY did whatever they wanted...
"Graybug Announces Name and Trading Symbol Change. GlobeNewswireMarch 20, 2023
REDWOOD CITY, Calif., March 20, 2023 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (Nasdaq: GRAY) (Graybug) today announced that it has changed its name to CalciMedica, Inc. (the Company), which will become effective at 4:02 pm ET. In connection with the name change, the Company has changed its trading symbol to "CALC." The Company's common stock will commence trading on March 21, 2023 on the Nasdaq Global Market under the trading symbol "CALC." The name and trading symbol change were undertaken in connection with the previously announced merger between Graybug and CalciMedica, Inc. (CalciMedica).
About Graybug:
Graybug is a clinical-stage biopharmaceutical company focused on developing transformative medicines for ocular diseases. Founded in 2011 based on technology licensed from the Johns Hopkins University School of Medicine, Graybug has offices in Redwood City, CA, and Baltimore, MD. For more information, please visit www.graybug.vision.
About CalciMedica:
CalciMedica is a clinical-stage biopharmaceutical company focused on developing therapies for life-threatening inflammatory diseases with high unmet need. CalciMedica's proprietary technology targets the inhibition of calcium release-activated calcium (CRAC) channels designed to modulate the immune response and protect against tissue cell injury, with the potential to provide therapeutic benefits in life-threatening inflammatory diseases for which there are currently no approved therapies. CalciMedica's lead product candidate Auxora, a proprietary, intravenous-formulated CRAC channel inhibitor, has demonstrated positive and consistent clinical results in four completed efficacy clinical trials. Auxora is in development for acute pancreatitis and asparaginase-associated pancreatitis. CalciMedica was founded by scientists from Torrey Pines Therapeutics and the Harvard CBR Institute for Biomedical Research, and is headquartered in La Jolla, CA. For more information, please visit www.calcimedica.com."
TruckingAngler
2 years ago
11/21/202/: Graybug merger confirmed!
“Graybug and CalciMedica Enter into Definitive Merger Agreement
Mentioned: GRAY
Graybug and CalciMedica Enter into Definitive Merger Agreement
-- Merger to create Nasdaq-listed, clinical-stage biopharmaceutical company focused on advancing CalciMedica's pipeline of first-in-class product candidates for life-threatening inflammatory diseases
-- Combined company is expected to be funded with cash and cash equivalents of approximately $35 million at closing, with an expected runway into the second half of 2024
-- Phase 2b results in acute pancreatitis for lead product candidate Auxora expected in second half of 2023
-- Companies will host joint webcast on November 22, 2022, at 8:00 a.m. Eastern Time
REDWOOD CITY, Calif. and LA JOLLA, Calif., Nov. 21, 2022 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (Nasdaq: GRAY) (Graybug) and CalciMedica Inc. (CalciMedica) today announced that they have entered into a definitive merger agreement to combine the companies in an all-stock transaction. The combined company will focus on further developing CalciMedica's lead product candidate Auxora(TM), a proprietary, intravenous-formulated, small molecule calcium-release activated calcium (CRAC) channel inhibitor, to treat life-threatening inflammatory diseases, such as acute pancreatitis (AP), asparaginase-associated pancreatitis (AAP), acute kidney injury (AKI), and acute hypoxemic respiratory failure (AHRF), for which there are no currently approved therapies. Auxora, which modulates the immune response and protects against tissue cell injury, has been studied in four completed efficacy clinical trials, demonstrating positive and consistent clinical results, as well as a favorable safety profile. Subject to each company's stockholder approval, the combined company is expected to trade on the Nasdaq Global Market.
With approximately $35 million in cash and cash equivalents anticipated from the combined company, including a private placement financing expected to occur immediately prior to the merger closing, the combined company is expected to have a cash runway into the second half of 2024, funding the advancement of Auxora in AP and AAP through clinical milestones in 2023. The proposed merger is expected to close in the first quarter of 2023.
"After completing a comprehensive strategic review, we determined that the proposed merger with CalciMedica would provide the best return for Graybug stockholders moving forward," said Frederic Guerard, Pharm.D., Chief Executive Officer of Graybug. "The decision by our management and board of directors to select CalciMedica to be our merger partner will allow our stockholders to participate in a company with a strong clinical-stage pipeline poised to revolutionize treatment for large, underserved patient populations suffering from life-threatening inflammatory diseases worldwide."
The combined company plans to advance the development of Auxora through multiple clinical trials and anticipates the following milestones in 2023:
-- Results from an ongoing Phase 2b clinical trial (CARPO) in AP patients with systemic inflammatory response syndrome (SIRS) in second half of 2023 -- CARPO is a randomized, double-blind, placebo-controlled, dose-ranging trial intended to establish efficacy in AP. It is expected to enroll 216 patients. AP can be a life-threatening condition where the pancreas becomes inflamed, sometimes leading to pancreatic cell death or necrosis, systemic inflammation, and organ failure. There are an estimated 275,000 hospitalizations for AP annually in the United States, of which approximately 40% present with SIRS, which can compromise the function of other tissues or organs, including the lungs, and is responsible for much of the mortality seen in AP. Details of the CARPO trial are available on clinicaltrials.gov (NCT04681066). -- Results from an ongoing investigator-sponsored Phase 1/2 clinical trial (CRSPA) in pediatric patients who develop AAP as a result of treatment with asparaginase for their underlying acute lymphoblastic leukemia (ALL) in first half of 2023 -- CRSPA is a Phase 1/2 trial being conducted in pediatric patients with AAP, which is acute pancreatitis resulting from the administration of asparaginase. Treatment with asparaginase triggers the development of AAP in 7-10% of patients with ALL, with more than half of those patients developing pancreatic necrosis. CalciMedica believes that the CRSPA trial has defined an optimal pediatric dose and plans to meet with the U.S. Food and Drug Administration in the first half of 2023 to determine the path forward for a potential accelerated approval of Auxora. Details of the CRSPA trial are available on clinicaltrials.gov (NCT04195347).
"I'm extremely pleased to announce this proposed merger with Graybug, which comes at a pivotal time for our company," said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. "This transaction will provide us with the financial strength to advance the development of our lead candidate, Auxora, in life-threatening inflammatory illnesses. We have multiple value-driving milestones expected over the next 12 months, including data from our Phase 2b CARPO clinical trial in patients with AP and a potential path to accelerated approval for Auxora in AAP. At CalciMedica, we are focused on delivering novel therapies that target CRAC channel inhibition to underserved patients with life-threatening inflammatory diseases for which no approved therapies exist. This transaction serves as a significant next step in the advancement of our important mission."
About the Proposed Transaction, Management and Organization
Graybug equity holders are expected to collectively own approximately 29% of the combined company, and pre-merger CalciMedica equity holders are expected to collectively own approximately 71% of the combined company, in each case, on a fully diluted basis using the treasury stock method. The percentage of the combined company that Graybug's equity holders will own as of the close of the transaction is subject to certain adjustments as described in the merger agreement, including an adjustment based on the amount of Graybug's net cash at closing.
Following the merger, the combined company will be headquartered in La Jolla, California and Rachel Leheny, Ph.D., will serve as Chief Executive Officer of the combined company. The merger agreement provides that the board of directors of the combined company will be composed of seven members, five selected by CalciMedica and two selected by Graybug.
The merger agreement has been unanimously approved by the boards of directors of both companies and is subject to the approvals by the stockholders of each company and other customary closing conditions.
Piper Sandler is serving as financial advisor and Fenwick & West LLP is serving as legal counsel to Graybug. Oppenheimer & Co. Inc. is serving as financial advisor and Cooley LLP is serving as legal counsel to CalciMedica.
Investor Conference Call Information
The companies will host a conference call and webcast presentation to discuss the proposed transaction as well as CalciMedica's technology and pipeline on Tuesday, November 22, 2022, at 8:00 a.m. ET. The live webcast and associated presentation can be accessed on the Investors and Media section of Graybug's website at https://investors.graybug.vision/news-events/events-presentations and CalciMedica's website at https://calcimedica.com/events, along with an archived replay following the live event. “
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stock1ace1
2 years ago
*** Pending Strategic Review/News ***
On June 28, 2022 we announced that we would conduct a comprehensive review of strategic alternatives focused on maximizing shareholder value. As part of our review, we are exploring the potential for an acquisition, company sale, merger, divestiture of assets, private placement of equity securities, or other strategic transactions. On August 11, 2022, we announced that all clinical development of GB-102, GB-401, and GB-501 had been put on hold to conserve capital pending the outcome of our strategic review.
StockLogistics
2 years ago
There won’t be news related to a scientific breakthrough, which if they continued their research could have occurred this winter, now investors have to hope for a merger or sale of company as best scenarios, they have enough money for 4th quarter 2023, but they don’t want to file a share registration because it would halve the SP and could be delisted, major losses reported in filing, maybe they find a buyer:
“Further clinical development is on hold pending outcome of strategic review — As part of Graybug’s previously announced cost-containment measures, all clinical development of GB-102, GB-401, and GB-501 has been put on hold to conserve capital pending outcome of its strategic review.”
“On June 28, 2022 we announced that we would conduct a comprehensive review of strategic alternatives focused on maximizing shareholder value. As part of our review, we are exploring the potential for an acquisition, company sale, merger, divestiture of assets, private placement of equity securities, or other strategic transactions. On August 11, 2022, we announced that all clinical development of GB-102, GB-401, and GB-501 had been put on hold to conserve capital pending the outcome of our strategic review.
“We expect to continue to incur net losses for the foreseeable future, and, subject to our strategic review, if we continue to operate our business as we have historically, we expect our research and development expenses, general and administrative expenses, and capital expenditures to continue to increase. In particular, we expect our expenses to increase if we continue our development of, and seek regulatory approvals for, our product candidates, and begin to commercialize any approved products, as well as hire additional personnel, develop commercial infrastructure, pay fees to outside consultants, lawyers and accountants, and incur increased costs associated with being a public company, such as expenses related to services associated with maintaining compliance with Nasdaq listing rules and SEC reporting requirements, insurance and investor relations. If we continue to operate our business as we have historically our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending upon the timing of our clinical trials and our expenditures on other research and development activities. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our accounts payable and accrued research and development and other current liabilities.
Recent Developments
Minimum Bid Price
On June 16, 2022, we received a written notification (the “Notice Letter”) from Nasdaq indicating that we were not in compliance with Nasdaq Listing Rule 5450(a)(1), as the closing bid price for our common stock was below the $1.00 per share requirement for the 30 prior consecutive business days which is the minimum closing price required to maintain continued listing on the Nasdaq Stock Market under Nasdaq Listing Rule 5450(a)(1) (the “Minimum Bid Requirement”). The Notice Letter stated that we had 180 calendar days, or until December 13, 2022, to regain compliance with the Minimum Bid Requirement.
On July 21, 2022, we received a written notification from Nasdaq indicating that we had regained compliance with Nasdaq Listing Rule 5550(a)(2) because the closing bid price of our common stock during the preceding ten consecutive business days, July 7, 2022 to July 20, 2022, had been at $1.00 per share or greater. Our continued compliance with the Minimum Bid Requirement is dependent on our share price and there can be no assurance that we will continue to satisfy Nasdaq’s minimum financial and other requirements in future periods.”
TruckingAngler
3 years ago
6/28 - GRAY $53m investment + retaining Piper Sandler is all UP from here..
“Graybug Announces Review Of Strategic Alternatives.
Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of ocular diseases, today announced that its Board of Directors will conduct a comprehensive review of strategic alternatives focused on maximizing shareholder value.
As part of this process, the Company will explore the potential for an acquisition, company sale, merger, divestiture of assets, private placement of equity securities, or other strategic transactions. As of March 31, 2022, the company's cash, cash equivalents, and short-term investments totaled $55.3 million. Graybug has retained Piper Sandler Companies to act as its financial advisor to assist with this review process.
'The goal of this strategic evaluation process is to ensure that we are exploring a range of possible options to maximize value for our shareholders while leveraging our diversified pipeline and experienced team. Pending the outcome of this review, cost-containment measures are being put in place to maximize our cash resources available,' said Frederic Guerard, PharmD, Chief Executive Officer of Graybug.”
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StockLogistics
3 years ago
“"We are very excited to move GB-102 into a Phase 2 clinical trial in wet AMD in the fourth quarter of 2022, while expanding our pipeline to address additional vision-threatening retinal and corneal diseases with high unmet patient needs. We plan to use our current cash to advance GB-102, GB-401 and GB-501 to clinical readouts in 2023," said Fred Guerard, PharmD, Chief Executive Officer of Graybug.
GB-102 for wet AMD: Graybug plans to proceed with a Phase 2 clinical trial of an optimized formulation of GB-102 in wet AMD patients following successful demonstration of improved performance in an extensive battery of novel in vitro stress tests. This decision, supported by a significantly more favorable competitive landscape following recent readouts of other long-acting vascular endothelial growth factor (VEGF) inhibitors, is anticipated to result in a six-month data readout available in the third quarter of 2023. "We are confident that our optimized formulation, together with modified patient inclusion criteria, will demonstrate efficacy similar to the current standard of care while also maintaining the unprecedented duration of up to 12 months observed in the ALTISSIMO trial," said Parisa Zamiri, MD, PhD, Chief Medical Officer of Graybug.
GB-401 for POAG: In glaucoma, poor patient compliance with eye drops frequently results in suboptimal control of intraocular pressure (IOP), and degeneration of the optic nerve, leading to irreversible vision loss. GB-401 is a potentially first-in-class implant formulation containing a novel prodrug of timolol injected intravitreally with a proprietary applicator, targeting twice-yearly treatment. Initiation of a Phase 1 trial with GB-401 is planned for the first quarter of 2023, with safety and efficacy data expected to be available in the second quarter of 2023.
GB-501 for MPS1 Corneal Clouding: Graybug recently acquired RainBIO, a start-up company based in North Carolina, that developed a first-in-class gene therapy for mucopolysaccharidosis type 1 (MPS1), an inherited lysosomal storage disorder with very high prevalence of corneal clouding despite existing systemic therapies (enzyme replacement or hematopoietic stem cell transplant). GB-501 received Orphan Drug Designation from the FDA and is eligible for a Priority Review Voucher upon approval. Preclinical studies in a dog model of MPS1 demonstrated complete and sustained clearing of the cornea in all dogs, regardless of disease severity, in less than a month following a single intrastromal injection. Two-year animal data support the potential for GB-501 to cure corneal clouding and restore vision in MPS1 patients. All patients required for the Phase 1/2a trial have been identified, IND submission is expected in the second quarter of 2023, and the data readout is expected in the fourth quarter of 2023.
GB-601 for Inherited Retinal Diseases: Inherited retinal disorders such as retinitis pigmentosa, Leber's congenital amaurosis, and Stargardt's disease are the consequence of over 280 genetic mutations. To date, only one drug has been approved to address a single mutation (RPE65), which accounts for a very small fraction of IRDs, leaving the vast majority of patients without therapeutic options. Graybug recently acquired a portfolio of novel cGMP analogs, supported by a well-characterized mode of action and preclinical data in established RP disease models, from Mireca Medicines GmbH, a German preclinical start-up company. Graybug is developing these cGMP analogs as first-in-class, mutation-agnostic long-acting therapeutics to treat a majority of patients with these diseases.
GB-701 for Geographic Atrophy: Geographic atrophy (GA) represents a significant unmet medical need with over five million patients worldwide suffering from this late-stage, age-related macular degeneration for which there is currently no FDA approved treatment. Recent clinical trials have indicated that targeting the complement pathway is suitable for slowing disease progression, but these investigational therapies require up to 12 injections per year. Graybug and Insilico Medicine, a clinical-stage, end-to-end artificial intelligence (AI)-drug discovery company, recently formed a strategic partnership to leverage Insilico's AI-driven small molecule discovery platform with Graybug's unique ocular drug delivery technologies enabling Graybug to develop a sustained-release, locally administered ocular formulation of a potent factor B inhibitor as a potential treatment for this vision-threatening disease.”
TruckingAngler
3 years ago
GRAY 4/27/2022: Graybug to Present Preclinical Data for GB-401 in Primary Open-Angle Glaucoma at the 2022 ARVO Annual Meeting May 1-4, 2022.
" Graybug Vision, Inc. (Nasdaq: GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of ocular diseases, today announced a poster presentation of preclinical data for GB-401 in primary open-angle glaucoma (POAG) at the upcoming Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, to be held at the Colorado Convention Center in Denver from May 1-4, 2022.
Information is listed below and available on the ARVO website.
In Vitro and In Vivo Characterizations of GB-401, a Sustained-Release Intravitreal Implant Containing a Beta-Adrenergic Antagonist Prodrug for POAG
Presenter: Yun Yu, PhD, Associate Director R&D, Graybug Vision
Poster Session: Drug Delivery
Date and Time: Wednesday May 4, 2022; 12:30 – 2:30 PM MT (2:30 – 4:30 PM ET). Location: Poster Hall - F0151 "
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