GBA PRESENTS- the public games

stonedinvestor · Aug 29, 2024

stonedinvestor said:
Ollie's Bargain Outlet raises FY24 adjusted EPS view $3.22-$3.30 » 07:36 OLLI

Seems like a mixed report that has the stk falling into support...

Worth watching for a buy.

OLLI Ollie's Bargain Outlet Holdings, Inc.

$94.09-0.94(-0.99%)4:00 PM 08/28/24
NASDAQ |$USD |Pre-Market:$86.00-8.09(-8.60%)8:02 AM
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Tempted to add this here- bounced off support/

OLLI Ollie's Bargain Outlet Holdings, Inc.

$88.92 -5.17(-5.49%)1:17 PM 08/29/24
NASDAQ |$USD |Realtime

stonedinvestor · Aug 29, 2024

I saw a rabid raccoon once and it's not a site you forget. Of course they have all kind of germs and my wife screams at me not to get as close as I do but Hamilton and I are about to cross the human/animal matrix when they trust you and take food from your hand.

God you should see the idiot analyst on CNBC right now talking about NVDA... These guys are going to get crushed, every one of them.

stonedinvestor · Aug 29, 2024

BOOT Boot Barn Holdings, Inc.
Still motoring along.
$139.52 +3.21(+2.35%)1:19 PM 08/29/24
NYSE |$USD |Realtime

vanzandt · Aug 29, 2024

stonedinvestor said:
I saw a rabid raccoon once and it's not a site you forget. Of course they have all kind of germs and my wife screams at me not to get as close as I do but Hamilton and I are about to cross the human/animal matrix when they trust you and take food from your hand.

God you should see the idiot analyst on CNBC right now talking about NVDA... These guys are going to get crushed, every one of them.
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I think tech is gonna start down, so it looks like we agree. Long live the Lizard King.

stonedinvestor · Aug 29, 2024

Watch->BNTX BioNTech SE
Does not trade with Vol here makes TA difficult. Probably duel listed>>>
$89.08 0.88(+1.00%)1:20 PM 08/29/24

GreatCamel · Aug 29, 2024

vanzandt said:
Camel, the dust has settled and I think we're running out of steam.
Get out of tech.

Compx 17747 SPX 5630
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Van - you're amazing. Thank you

market too green today and NVDA in red hmmm

vanzandt · Aug 29, 2024

vanzandt said:
LONDON and NEW YORK, Aug. 12, 2024 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical-stage genetic medicine company, today announced financial and operational results for the second quarter ended June 30, 2024, and provided a corporate update. The Company also announced that it has agreed to sell 12.5 million ordinary shares at a price of $4.00 per share. MeiraGTx anticipates aggregate gross proceeds from the offering will be $50 million.

The financing was led by Sanofi, which made a $30 million equity investment in the Company through the offering. Other participants included Perceptive Advisors and leading institutional healthcare funds. The offering is expected to close on or about August 13, 2024, subject to customary closing conditions.

“We are very pleased to receive additional investment from Sanofi and other investors,” said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. “The additional funds will allow us to accelerate development of our riboswitch in vivo delivery platform to the clinic with our completely novel and differentiated approach to treating obesity and metabolic disease.”

Dr. Forbes continued, “Our lead clinical programs are all progressing well with several important milestones coming before the end of this year. We continue to enroll our pivotal Phase 2 AQUAx2 clinical trial for Grade 2/3 radiation-induced xerostomia that could support a potential BLA filing in 2026. We also anticipate results from our blinded, placebo controlled bridging study of AAV-GAD for Parkinson’s disease which will allow discussions with global regulatory agencies on the Phase 3 clinical program.”

Dr. Forbes continued, “We anticipate data from the Phase 3 LUMEOS trial of bota-vec for XLRP in collaboration with Johnson & Johnson Innovative Medicine (formally known as Janssen) this year. We are eligible to receive up to $285 million upon the first commercial sales of bota-vec in the U.S. and EU and manufacturing tech transfer. Additionally, our riboswitch in vivo delivery platform continues to show encouraging data in obesity and metabolic disease as well as CAR-T and other areas, and we look forward to sharing updates later this year.”

Dr. Forbes concluded, “Finally, we are very excited to have been awarded an Innovation Passport Designation for AAV8-RK-AIPL1 for the treatment of LCA4, granting us entry into the U.K.’s Innovative Licensing and Access Pathway (ILAP). We are working closely with the ILAP Steering Group to advance AAV8-RK-AIPL1 as quickly as possible towards potential approval and ultimately deliver it to babies who were previously deemed untreatable and destined to be blind for life. The results from the 11 infants and toddlers treated to date are truly remarkable, with every one of the children treated who were all blind at birth now having visual acuity.”

Recent Development Highlights and Anticipated Milestones

AAV2-hAQP1 for the Treatment of Xerostomia:

Data from the Company’s Phase 1 AQUAx clinical trial were presented in an oral session at the AAOM 2024 annual meeting in April, demonstrating that treatment with AAV2-hAQP1 resulted in significant improvements across three different patient-reported outcomes and in saliva production, with no treatment-related serious adverse events or dose-limiting toxicities reported.
The Company continues to enroll and dose participants at multiple sites in the U.S., Canada and the U.K. in the Phase 2 AQUAx2 (NCT05926765) randomized, double-blind, placebo-controlled study.

The Company recently gained alignment with the FDA on requirements for the ongoing Phase 2 AQUAx2 clinical trial for Grade 2/3 radiation-induced xerostomia to be considered a pivotal trial in support of a potential BLA filing.

AAV-GAD for the Treatment of Parkinson’s Disease:

The Company completed dosing patients in the Phase 1 trial of AAV-GAD under a new IND with material manufactured in its GMP facility in London, U.K. using MeiraGTx’s proprietary production process in Q1 2024.

The Company anticipates results from the study in the fourth quarter of 2024. The AAV-GAD trial is a three-arm randomized clinical bridging study with subjects randomized to sham control or one of two doses of AAV-GAD to evaluate the safety and tolerability of AAV-GAD when delivered to the subthalamic nucleus (STN) of patients with Parkinson’s disease (NCT05603312).

The Company intends to initiate discussions with global regulatory agencies in the fourth quarter 2024 around the Phase 3 clinical program.

Bota-vec for the Treatment of XLRP:

Data from the Phase 1/2 study of bota-vec in XLRP was published in the American Journal of Ophthalmology. The study showed that treatment with bota-vec led to improvements in functional vision, as well as retinal and visual functions, compared to untreated controls. The article “Phase 1/2 AAV5-hRKp.RPGR (Botaretigene Sparoparvovec) Gene Therapy: Safety and Efficacy in RPGR-Associated X-Linked Retinitis Pigmentosa” is available online.

MeiraGTx anticipates receiving an additional $15 million in milestone payments later in 2024 and will receive up to a further $285 million upon first commercial sales of bota-vec in the U.S. and EU and for manufacturing technology transfer.

MeiraGTx also entered into a commercial supply agreement with Johnson & Johnson Innovative Medicine for bota-vec manufacturing, which the Company anticipates will generate additional revenue during the product launch.

AAV-AIPL1 Specials License in the U.K.:

MeiraGTx was awarded an Innovation Passport Designation by the U.K. Innovative Licensing and Access Pathway Steering Group for AAV8-RK-AIPL1.
Designation provides entry into the U.K.’s Innovative Licensing and Access Pathway (ILAP) designed to accelerate time to market and patient access to innovative medicines.
Other benefits of ILAP include access to a range of development tools, such as the potential for accelerated Marketing Authorization Application (MAA) assessment, rolling review, and a continuous benefit-risk assessment, or potential Marketing Authorization under Exceptional Circumstances.

Meaningful responses have been observed in 11 out of 11 LCA4 children treated to date with AAV-AIPL1. All children were treated between 1 and 3 years old, all were blind on treatment, and all gained visual acuity 4 or more weeks following treatment.

The Company’s AAV-AIPL1 for the treatment of inherited retinal dystrophy due to defects in the AIPL1 gene has been granted orphan drug designation by the FDA and orphan designation by the European Commission.

Riboswitch Gene Regulation Technology: Upcoming R&D Day

Later this year, the Company intends to present data from its riboswitch gene regulation technology platform for in vivo delivery at an R&D Day highlighting encouraging data in metabolic disease models as well as CAR-T for both oncology and autoimmune diseases:

Obesity and metabolic disease: The company has successfully delivered multiple combinations of gut peptides in vivo including GLP-1, GIP, PYY, Glucagon, and Oxyntomodulin as well as novel myokine and adipokine peptides that drive muscle metabolism and fat storage, via the riboswitch platform. This proprietary in vivo delivery technology allows daily dosing with a small molecule to drive the production of natural short lived peptides within the body in physiologically relevant combinations and timing. This provides a platform for addressing not just weight loss via reduced appetite, but also muscle strength, fat metabolism, cardiovascular health and neurodegenerative disorders in metabolic disease, with daily oral small molecules.
CAR-T for both oncology and autoimmune disease: Precise control of levels and timing of the CAR with our riboswitch platform has demonstrated a significant impact on CAR-T efficacy, with a 3-4 fold improvement in in vivo potency of T-cells with regulated CAR compared to the currently approved CAR-T with unregulated constitutively active CAR. In addition, MeiraGTx’s regulated CAR-T displays a normal naïve T-cell profile, lacking exhaustion markers and retaining proliferation and killing ability in contrast to CAR-T with unregulated constitutive CAR expression.

As of June 30, 2024, MeiraGTx had cash and cash equivalents of approximately $100.0 million as well as approximately $1.6 million in receivables due from Johnson & Johnson Innovative Medicine. The Company believes that with such funds, as well as anticipated near-term milestones from Johnson & Johnson Innovative Medicine under the asset purchase agreement, together with the proceeds from the offering and tax incentive receivable, it will have sufficient capital to fund operating expenses and capital expenditure requirements into the second quarter of 2026. This estimate does not include the $285.0 million in milestones the Company is eligible to receive under the asset purchase agreement upon first commercial sale of bota-vec in the United States and in at least one of the United Kingdom, France, Germany, Spain and Italy, and for completion of the transfer of certain manufacturing technology.

Financial Results

Cash, cash equivalents and restricted cash were $101.0 million as of June 30, 2024, compared to $130.6 million as of December 31, 2023.

Service revenue was $0.3 million for the three months ended June 30, 2024 due to progress of process performance qualification services under the asset purchase agreement with Johnson & Johnson Innovative Medicine.

There was no license revenue for the three months ended June 30, 2024, compared to $3.5 million for the three months ended June 30, 2023. The decrease is due to the termination of the collaboration agreement concurrent with the execution of the asset purchase agreement with Johnson & Johnson Innovative Medicine.

General and administrative expenses were $11.3 million for the three months ended June 30, 2024, compared to $12.4 million for the three months ended June 30, 2023. The decrease of $1.1 million was primarily due to a decrease in share-based compensation, payroll and payroll-related costs, insurance costs and rent and facilities costs. These decreases were partially offset by an increase in consulting fees and other office related costs.

Research and development expenses for the three months ended June 30, 2024 were $34.9 million, compared to $19.9 million for the three months ended June 30, 2023. The increase of $15.0 million was primarily due to a decrease in reimbursements from Johnson & Johnson Innovative Medicine as the reimbursement for the three months ended June 30, 2023 was in connection with research funding provided under the collaboration agreement, which was terminated on December 20, 2023, whereas the reimbursement for the three months ended June 30, 2024 was in connection with transition services we provided to Johnson & Johnson Innovative Medicine. Additionally, expenses related to our preclinical programs increased primarily related to development of our gene regulation technology. These increases were partially offset by decreases in manufacturing costs primarily due to an increase in the number of batches of clinical trial material produced during the three months ended June 30, 2024 compared to the three months ended June 30, 2023, which costs were charged to the clinical programs, a decrease in other research and development costs, as well as a decrease in clinical trial expenses primarily related to bota-vec as Johnson & Johnson Innovative Medicine is now primarily funding the expenses related to this program as a result of the asset purchase agreement. The decrease in expenses related to bota-vec were partially offset by an increase in expenses related to our other clinical programs, primarily AAV-hAQP1.

Foreign currency loss was $0.3 million for the three months ended June 30, 2024, compared to a gain of $1.9 million for the three months ended June 30, 2023. The change of $2.2 million was primarily due to the restructuring and payment of certain intercompany receivables and payables. Foreign currency gains and losses subsequent to the restructuring are recorded as a part of accumulated other comprehensive income.

Interest income was $0.8 million for the three months ended June 30, 2024, compared to $0.7 million for the three months ended June 30, 2023. The increase of $0.1 million was due to higher interest rates and cash balances during 2024.

Interest expense was $3.3 million for each of the three months ended June 30, 2024 and June 30, 2023.

Net loss attributable to ordinary shareholders for the quarter ended June 30, 2024, was $48.6 million, or $0.76 basic and diluted net loss per ordinary share, compared to a net loss attributable to ordinary shareholders of $29.6 million, or $0.53 basic and diluted net loss per ordinary share for the quarter ended June 30, 2023.

About MeiraGTx
MeiraGTx (Nasdaq: MGTX) is a vertically integrated, clinical-stage genetic medicine company with a broad pipeline of late-stage clinical programs supported by end-to-end manufacturing capabilities. MeiraGTx has an internally developed manufacturing platform process, internal plasmid production for GMP, two GMP viral vector production facilities as well as an in-house Quality Control hub for stability and release, all fit for IND through commercial supply. MeiraGTx has core capabilities in viral vector design and optimization and a potentially transformative riboswitch gene regulation platform technology that allows for the precise, dose-responsive control of gene expression by oral small molecules. MeiraGTx is focusing the riboswitch platform on delivery of metabolic peptides including GLP-1, GIP, Glucagon and PYY using oral small molecules, as well as cell therapy for oncology and autoimmune diseases. Although initially focusing on the eye, central nervous system, and salivary gland, MeiraGTx has developed the technology to apply genetic medicine to more common diseases, increasing efficacy, addressing novel targets, and expanding access in some of the largest disease areas where the unmet need remains great.
_____________________________________________

Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx.

"Dr. Forbes"
MGTX---> $4
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This thing sure does seem to have a lot of support at $4
MGTX--> $4.25

TrailerParkTed · Aug 29, 2024

played my lotto tickets, $473 QQQ puts. .50ish, out $2s.

TrailerParkTed · Aug 29, 2024

TrailerParkTed said:
played my lotto tickets, $473 QQQ puts. .50ish, out $2s.
More...

Why the Nasdaq tank? Any guesses?

stonedinvestor · Aug 29, 2024

It's all a game Ted to some. I warned you all many times. I took you from the depths of hell to heaven and then out avoiding the carnage that many stocks have yet to recover from then I got you back in just in time to enjoy this run and out again beore more harm.. I am constantly fighting for your well being. I have your back.

As of 1966 humans still could not dance.