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MULN 10k must be even worse? Talks of RS?
L2 looks like someone knows something DWAC
What triggered the end day DWAC bump?
GLTA
Ding, ding, ding. Nice MARA $7s...
GLTA
MARA loooking gooooddd !!!
Yes Bitcoin blew through $18,100.
MARA easy 7s…
GLTA
MARA May see 7s with BTC touching 18k after hours…
GLTA
Great thing about MARA is todays continued BTC rise... Today likely bargain pps will be at least +$1 tomorrow... IMO ? !!
GLTA
Yeah $4.50 is likely after the 1:10 split...
SNGX assures news & progress 2023 so maybe that $4.50 post split will see $20....
GLTA
I remember TLSS 2022 when my avg .0149s were in the GREEN...
Nice news on another acquisition... Can it happen again? Short term? !!!
GLTA
1/09/2023 Watching Soligenix: Zacks Small-Cap Research Sets $4.50 Price Valuation 10:21 am ET January 9, 2023 (Benzinga)...
GLTA
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MULN mid-day dip. Let’s hope for another end of day rip.
GLTA
MULN over .42 after hours!
100%. MULN still going UP after-hours.
GLTA
I just checked my MULN avg $2.34... How'd that happen?!!
GLTA
SNGX must own by today 1/03/2023 to get Divi/Preffered D shares.
Buy em UP...
“Princeton, NJ – December 23, 2022 – Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its Board of Directors declared a dividend of one one-thousandth of a share of newly designated Series D Preferred Stock, par value $0.001 per share, for each outstanding share of the Company’s common stock held of record as of 5:00 p.m. Eastern Standard Time on January 3, 2023. The shares of Series D Preferred Stock will be distributed to such recipients at 5:00 p.m. Eastern Standard Time on January 4, 2023. The outstanding shares of Series D Preferred Stock will vote together with the outstanding shares of the Company’s common stock, as a single class, exclusively with respect to a reverse stock split, as well as any proposal to adjourn any meeting of stockholders called for the purpose of voting on the reverse stock split, and will not be entitled to vote on any other matter, except to the extent required under the Delaware General Corporation Law. Subject to certain limitations, each outstanding share of Series D Preferred Stock will have 1,000,000 votes per share (or 1,000 votes per one one-thousandth of a share of Series D Preferred Stock)."
GLTA
DWAC on the way UP. Subpoena is DEAD.
12/28 Trump subpoena WITHDRAWN.
GLTA
Yeah yeah… SNGX volume so low today says no panic selling.
I still have ENTI fake shares from years ago same & since never authorized I can’t even have broker make them disappear
I saw no reverse ratio confirmed- only a vote for reverse split. My thoughts are this “distribution” of preferred could cause pps over $1 as outstanding still so low 43m can move FAST. Then no r/s needed. GLTA and Merry Christmas!
SNGX distribution of Preferred to Common stock holders as of 1/03/2023 !
“Princeton, NJ – December 23, 2022 – Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its Board of Directors declared a dividend of one one-thousandth of a share of newly designated Series D Preferred Stock, par value $0.001 per share, for each outstanding share of the Company’s common stock held of record as of 5:00 p.m. Eastern Standard Time on January 3, 2023. The shares of Series D Preferred Stock will be distributed to such recipients at 5:00 p.m. Eastern Standard Time on January 4, 2023. The outstanding shares of Series D Preferred Stock will vote together with the outstanding shares of the Company’s common stock, as a single class, exclusively with respect to a reverse stock split, as well as any proposal to adjourn any meeting of stockholders called for the purpose of voting on the reverse stock split, and will not be entitled to vote on any other matter, except to the extent required under the Delaware General Corporation Law. Subject to certain limitations, each outstanding share of Series D Preferred Stock will have 1,000,000 votes per share (or 1,000 votes per one one-thousandth of a share of Series D Preferred Stock).
“The current market conditions have been extremely difficult for many companies both large and small, and Soligenix is no exception,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “After receiving the Nasdaq deficiency letter stating that the Company no longer met the required $1.00 minimum bid price, we were hopeful that our important 2022 milestones such as the submission of the HyBryte™ new drug application (NDA), had the potential to put the Company back in compliance with Nasdaq requirements. Unfortunately, while achieving these major milestones, our stock price did not respond as we had hoped in these difficult global market conditions. Therefore, we are now faced with having to consider a reverse stock split in order to maintain our Nasdaq listing, which is very important for the Company’s future success as we move toward potential NDA approval and U.S. launch, and continue partnership discussions. It should also make our stock more attractive to larger institutional investors.”
All shares of Series D Preferred Stock that are not present in person or by proxy at the meeting of stockholders held to vote on the reverse stock split as of immediately prior to the opening of the polls at such meeting will automatically be redeemed by the Company. Any outstanding shares of Series D Preferred Stock that have not been so redeemed will be redeemed if such redemption is ordered by the Company’s Board of Directors or automatically upon the approval by the Company’s stockholders of an amendment to the Company’s certificate of incorporation effecting the reverse stock split at such meeting.
The Series D Preferred Stock will be uncertificated, and no shares of Series D Preferred Stock will be transferable by any holder thereof except in connection with a transfer by such holder of any shares of the Company’s common stock held by such holder. In that case, a number of one one-thousandths of a share of Series D Preferred Stock equal to the number of shares of the Company’s common stock to be transferred by such holder would be transferred to the transferee of such shares of common stock.
Further details regarding the Series D Preferred Stock will be contained in a report on Form 8-K to be filed by the Company with the Securities and Exchange Commission.”
GLTA
Today is a great day for DWAC...
GLTA
MULN my biggest Turd of 2022...
GLTA
SNGX p/r 12/19/2022: Soligenix Initiates Phase 2 Clinical Trial of SGX302 (synthetic hypericin) for the Treatment of Mild-to-Moderate Psoriasis. 7:30 am ET December 19, 2022
Study HPN-PSR-01 opens patient enrollment
Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that patient enrollment has been opened for its Phase 2a study (protocol number HPN-PSR-01) evaluating SGX302 (synthetic hypericin) in the treatment of mild-to-moderate psoriasis. Psoriasis is an ongoing unmet medical need, with as many as 7.5 million people in the U.S. and 60-125 million people worldwide affected by this incurable disease.
- "We are excited to expand synthetic hypericin's development into different cutaneous T-cell diseases such as psoriasis, as a component of our long-term strategy to enhance the value of this unique compound," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Given our promising published results with hypericin to date, including a small Phase 1/2 proof of concept clinical trial in mild-to-moderate psoriasis, and the Phase 3 FLASH study in cutaneous T-cell lymphoma, where we filed a New Drug Application (NDA) this month, we are hopeful synthetic hypericin will have a role to play in helping patients suffering from this difficult to treat and chronic disease."
- The Phase 2a clinical trial (protocol number HPN-PSR-01) will target enrollment of up to 42 patients ages 18 years or older with mild to moderate, stable psoriasis covering 2 to 30% of their body. In both Parts A and B, all patients will apply the study drug twice per week and will activate the drug with visible light 24 ± 6 hours later using the supplied visible light devices and according to the manufacturer's instructions. Patients will undergo treatments for a total of 18 weeks and, on completion, will be followed for a 4-week follow-up period in which patients will not receive other psoriasis treatments. In Part A, 5-10 patients will be assigned open-label SGX302 (0.25% hypericin) at the time of enrollment. Once the tolerability and response to SGX302 has been established, Part B of the protocol will commence. In Part B, patients will be randomized to double-blind treatment groups at a ratio 1:1 of active drug to placebo ointment.
- Active dermatologic assessment of treated lesions for adverse events will be performed immediately before and during light treatments. Patients will be assessed for overall disease status through 4 weeks of follow-up. Efficacy endpoints will include the extent of lesion clearance and patient reported quality of life indices. Routine safety laboratories also will be collected.
About Synthetic Hypericin:
- Visible light-activated synthetic hypericin is a novel, first-in-class, photodynamic therapy (PDT) that is expected to avoid much of the long-term risks associated with other PDT treatments. Synthetic hypericin is a potent photosensitizer that is topically applied to skin lesions and taken up by cutaneous T-cells. With subsequent activation by safe, visible light, T-cell apoptosis is induced, addressing the root cause of psoriasis lesions. Other PDTs have shown efficacy in psoriasis with a similar apoptotic mechanism, albeit using ultraviolet (UV) light associated with more severe potential long-term safety concerns. The use of visible light in the red-yellow spectrum has the advantage of deeper penetration into the skin (much more than UV light) potentially treating deeper skin disease and thicker plaques and lesions, similar to what was observed in the positive Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study in CTCL. Synthetic hypericin or HyBryte™ (the tradename used in CTCL) was demonstrated in this study to be equally effective in treating both plaque (42% treatment response rate after 12 weeks treatment, p<0.0001 relative to placebo treatment) and patch (37%, p=0.0009) lesions in this orphan disease caused by malignant T-cells. In a published Phase 1/2 proof of concept clinical study using synthetic hypericin, efficacy was demonstrated in patients with CTCL (58.3% response, p=0.04) as well as psoriasis (80% response, p<0.02).
- This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with both the frequently used DNA-damaging drugs and other phototherapies that are dependent on UV A or B exposure. The use of synthetic hypericin coupled with safe, visible light also avoids the risk of serious infections and cancer associated with the systemic immunosuppressive treatments used in psoriasis.
- The Phase 3 FLASH trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly in 6-week cycles. In the first double-blind treatment cycle, 116 patients received HyBryte™ treatment and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte™ achieved at least a 50% reduction in their lesions (using the standard Composite Assessment of Index Lesions Severity [CAILS] score) compared to only 4% of patients in the placebo group after just 6 weeks of treatment (p=0.04). Further treatment with HyBryte™ increased the number of treatment successes to 40% and 49% after 12 and 18 weeks, respectively (p<0.0001 for both). Additional analyses also indicated that HyBryte™ is equally effective in treating both plaque (42% treatment response rate after 12 weeks treatment, p<0.0001 relative to placebo treatment in Cycle 1) and patch (37%, p=0.0009) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions. This is also relevant to psoriasis where the lesions can be thicker than the patches observed in CTCL.
- In a subset of patients evaluated during their third treatment cycle, it was demonstrated that HyBryte™ is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte™ continued to be well tolerated despite extended and increased use of the product to treat multiple lesions.
About Psoriasis :
Psoriasis is a chronic, non-communicable, itchy and often painful inflammatory skin condition for which there is no cure. Psoriasis has a significantly detrimental impact on patients' quality of life, and is associated with cardiovascular, arthritic, and metabolic diseases, as well as psychological conditions such as anxiety, depression and suicide. Many factors contribute to development of psoriasis including both genetic and environmental factors (e.g., skin trauma, infections, and medications). The lesions develop because of rapidly proliferating skin cells, driven by autoimmune T-cell mediated inflammation. Of the various types of psoriasis, plaque psoriasis is the most common and is characterized by dry, red raised plaques that are covered by silvery-white scales occurring most commonly on the elbows, knees, scalp, and lower back. Approximately 80% of patients have mild-to-moderate disease. Mild psoriasis is generally characterized by the involvement of less than 3% of the body surface area (BSA), while moderate psoriasis will typically involve 3-10% BSA and severe psoriasis greater than 10% BSA. Between 20% and 30% of individuals with psoriasis will go on to develop chronic, inflammatory arthritis (psoriatic arthritis) that can lead to joint deformations and disability. Studies have also associated psoriasis, and particularly severe psoriasis, with an increased relative risk of lymphoma, particularly CTCL. Although psoriasis can occur at any age, most patients present with the condition before age 35.
- Treatment of psoriasis is based on its severity at the time of presentation with the goal of controlling symptoms. It varies from topical options including PDT to reduce pain and itching, and potentially reduce the inflammation driving plaque formation, to systemic treatments for more severe disease. Most common systemic treatments and even current topical photo/photodynamic therapy such as UV A and B, carry a risk of increased skin cancer.
- Psoriasis is the most common immune-mediated inflammatory skin disease. According to the World Health Organization (WHO) Global Report on Psoriasis 2016, the prevalence of psoriasis is between 1.5% and 5% in most developed countries, with some suggestions of incidence increasing with time. It is estimated, based upon review of historic published studies and reports and an interpolation of data that psoriasis affects 3% of the U.S. population or more than 7.5 million people. Current estimates have as many as 60-125 million people worldwide living with the condition. The global psoriasis treatment market was valued at approximately $15 billion in 2020 and is projected to reach as much as $40 billion by 2027."
GLTA
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Wow MULN debt% is great then! After Q1 sales $200m should be very cash possitive !
GLTA
Tomorrow 12/16 is Quadruple Witch Friday so should make MARA current short interest very interesting…
“The four types of derivatives expiring on quadruple witching are:
- Stock index futures contracts
- Single-stock options
- Options on stock-index futures
- Stock index options”
GLTA
Tomorrow 12/16 is Quadruple Witch Friday so should make SNGX current short interest very interesting…
“The four types of derivatives expiring on quadruple witching are:
- Stock index futures contracts
- Single-stock options
- Options on stock-index futures
- Stock index options”
GLTA
Tomorrow 12/16 is Quadruple Witch Friday so should make MULN current short interest very interesting…
“The four types of derivatives expiring on quadruple witching are:
- Stock index futures contracts
- Single-stock options
- Options on stock-index futures
- Stock index options”
GLTA
SNGX p/r 12/15/2022: "Soligenix Announces Submission of New Drug Application to the FDA for HyBryte™ in the Treatment of Cutaneous T-cell Lymphoma
7:30 am ET December 15, 2022 (PR Newswire) Print
Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it submitted a new drug application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for HyBryte™ (synthetic hypericin) in the treatment of early stage cutaneous T-cell lymphoma (CTCL), a rare cancer and area of unmet medical need affecting over 25,000 patients in the U.S. The Company estimates the potential worldwide market for HyBryte™ to be in excess of $250 million for the treatment of CTCL.
https://mma.prnewswire.com/media/1514137/HyBryte_High_Resolution_Logo.jpg
"The submission of our NDA is a significant milestone forSoligenix, positioning us well to fulfill our promise to offer an innovative first-in-class therapy to the CTCL community of patients, families and healthcare professionals," statedChristopher J. Schaber, PhD, President and Chief Executive Officer ofSoligenix. "CTCL is an incredibly difficult to treat orphan disease and remains an area of unmet medical need with a very limited number of safe and effective treatment options. The clinical results we've generated throughout the development program support the potential for HyBryte™ to serve as an important front-line treatment in the management of this chronic cancer. We look forward to working with the FDA through the review process. As the NDA has been granted both FDA orphan drug and fast track designations, we anticipate potential approval in the second half of 2023 as we continue advancing our preparations for U.S. launch, which is currently targeted for first quarter 2024."
About HyBryte™
HyBryte™ (research name SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte™ is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by visible light approximately 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective. HyBryte™ has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency (EMA).
The recently published Phase 3 FLASH trialenrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle, 116 patients received HyBryte™ treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte™ achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). HyBryte™ treatment in the first cycle was safe and well tolerated.
In the second open-label treatment cycle (Cycle 2), all patients received HyBryte™ treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of HyBryte™ treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of HyBryte™ treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p<0.0001 vs the placebo treatment rate in Cycle 1). Comparison of the 12-week and 6-week treatment groups also revealed a statistically significant improvement (p<0.0001) between the two groups, indicating that continued treatment results in better outcomes. HyBryte™ continued to be safe and well tolerated. Additional analyses also indicated that HyBryte™ is equally effective in treating both plaque (response 42%, p<0.0001 relative to placebo treatment in Cycle 1) and patch (response 37%, p=0.0009 relative to placebo treatment in Cycle 1) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions in particular.
The third (optional) treatment cycle (Cycle 3) was focused on safety and all patients could elect to receive HyBryte™ treatment of all their lesions. Of note, 66% of patients elected to continue with this optional compassionate use / safety cycle of the study. Of the subset of patients that received HyBryte™ throughout all 3 cycles of treatment, 49% of them demonstrated a positive treatment response (p<0.0001 vs patients receiving placebo in Cycle 1). Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that HyBryte™ is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte™ continued to be well tolerated despite extended and increased use of the product to treat multiple lesions.
Overall safety of HyBryte™ is a critical attribute of this treatment and was monitored throughout the three treatment cycles (Cycles 1, 2 and 3) and the 6-month follow-up period. HyBryte's™ mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant and sometimes fatal, side effects. Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging. Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available. Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product. HyBryte™ potentially represents the safest available efficacious treatment for CTCL. With very limited systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues.
The Phase 3 CTCL clinical study was partially funded by the National Cancer Institute via a Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc.
About Cutaneous T-Cell Lymphoma (CTCL)
CTCLis a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These malignant cells migrate to the skin where they form various lesions, typically beginning as patches and may progress to raised plaques and tumors. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL. Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.
CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 700,000 individuals living with the disease. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 25,000 individuals in the U.S., with approximately 3,000 new cases seen annually."
GLTA
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Should see MULN through it 3-3:30…
GLTA
DWAC about to run…
GLTA
MARA looks like time to go all in... IMO ?
GLTA
MULN may be my 1st ride to ZERO.
Sure looks like it today…
GLTA
Overall value will 3x so seems GREAT?
Why is GRAY tanking on this merger news?
GRAY merger announce so you did well!
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. “
GLTA
That article is heinously irrelevant.
DWAC strong future ahead..,
GLTA
DWAC filing clearly stated “whether or not Trump runs for any political position”. Read filing you’ll agree this announcement is only positive for DWAC. Short term, long term, whatever…
GLTA
Why the DWAC dip today?
I like oyster & beer.
I like trump