GBA Presents: House of Gummy-!

Being very close to the border
stonedinvestor said:
OMG I own this fucking stock!!!

What! I forgot.

Checkpoint Therapeutics was hit with a complete response letter for cosibelimab, citing manufacturing deficiencies. That CRL came in December, a month before January’s action date, and though Checkpoint aims for a mid-2024 resubmission it is running low on cash.
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So we're still friends? No bottom here? $CKPT
 
Just a tragic tragic basketball game. I am wrecked. The loss has sapped me of all optimism about everything. I am in a funk. This will be tough to recover from. Agonizing. I'm doubting everything now. My trip- did I overstep- we should just save the money. But then I would never travel. It came from a good place but I'm a mess-- don't take any of my advice until we win this series.

I was searching for something else and came upon this post from Radio Savant- Sometimes you can find good ideas this way. This stk actually topped out $12.60 so it was a big return call. It's come back a bit> maybe worth a look-

->ARCO This is the only name I have on watch along with CCCS & Viking.

Arcos Dorados Holdings Inc. (ARCO)
NYSE - Nasdaq Real Time Price.
7.92+0.01(+0.13%)
As of 12:04PM EDT. Market open.

#16915 Apr 28, 2023 Report
Reply Share

Now-> $10.75

ARCO Arcos Dorados Holdings Inc.

$10.75-0.04(-0.32%)10:02 AM 05/01/24
NYSE |$USD |Realtime

Company Profile
ARCO

Arcos Dorados Holdings Inc. operates as a franchisee of McDonald’s restaurants. It has the exclusive right to own, operate, and grant franchises of McDonald’s restaurants in 20 countries and territories in Latin America and the Caribbean, including Argentina, Aruba, Brazil, Chile, Colombia, Costa Rica, Curacao, Ecuador, French Guiana, Guadeloupe, Martinique, Mexico, Panama, Peru, Puerto Rico, Trinidad and Tobago, Uruguay, the U.S. Virgin Islands of St. Croix and St. Thomas, and Venezuela. The company was founded in 2007 and is based in Montevideo, Uruguay.
 
GreatCamel said:
Being very close to the border



So we're still friends? No bottom here? $CKPT
More...





Of course friends.. it's like the friend who comes over and says did you forget the dead relative in the closet!

This CKPT the thesis was so clear-- their drug was rejected for manufacturing reasons not the drug itself-- so common sense you buy the plunge and they re submit and then everyone is happy...

Life does not always walk a straight path!

It's been too long. and the cash position is to low-- these guys burn through $45+mil a year R&D....

My suspicion YES YOU WILL DOUBLE YOUR MONEY. I would think. YES they will drop a secondary as soon as they can.

It's just become complex)

Checkpoint Therapeutics Reports Full-Year 2023 Financial Results and Recent Corporate Highlights
March 22, 2024 8:30am
WALTHAM, Mass., March 22, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the full-year ended December 31, 2023, and recent corporate highlights.

James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, “We continue to work closely with our third-party contract manufacturing organization to expeditiously resolve the deficiencies noted in the complete response letter (“CRL”) we received last December, and are targeting a Biologics License Application (“BLA”) resubmission for cosibelimab by mid-year to potentially obtain marketing approval before the end of 2024. Simultaneously, we continue to execute on a select number of key long lead time commercial launch preparation activities to shorten our launch timeline in anticipation of a potential approval. We remain highly confident in the clinical data and safety package in support of cosibelimab. We look forward to providing additional updates in the second quarter.”

2023 and Recent Corporate Highlights:

  • Checkpoint submitted a BLA to the FDA seeking approval of cosibelimab in January 2023 and the FDA accepted the BLA for filing in March 2023. In December 2023, the FDA issued a CRL for the cosibelimab BLA. The CRL only cited findings that arose during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization as approvability issues to address in a resubmission. The CRL did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab. Checkpoint intends to address the feedback in a BLA resubmission to potentially enable marketing approval in 2024.
  • In December 2023, Checkpoint announced that the U.S. Patent and Trademark Office (“USPTO”) issued a new patent (U.S. Patent No. 11,834,505) covering a method of treating various cancers, including cutaneous squamous cell carcinoma (“cSCC”), through the administration of cosibelimab. Checkpoint secured U.S. patent protection for cosibelimab through at least May 2038.
  • In October 2023, Checkpoint announced the publication of results from the multicenter, multiregional, pivotal trial evaluating cosibelimab in patients with metastatic cSCC in theJournal for ImmunoTherapy of Cancer (JITC), the peer-reviewed, online journal of the Society of Immunotherapy of Cancer. The paper, entitled, “Efficacy and Safety of Cosibelimab, an Anti–PD-L1 Antibody, in Metastatic Cutaneous Squamous Cell Carcinoma”, describes safety and efficacy results from 78 patients with metastatic cSCC enrolled at clinical sites in eight countries.
  • In July 2023, Checkpoint announced new, longer-term data for cosibelimab from its pivotal studies in locally advanced and metastatic cSCC. These results demonstrate a deepening of response over time, resulting in higher complete response rates than previously reported (55% objective response rate; 26% complete response rate in locally advanced cSCC and 50% objective response rate; 13% complete response rate in metastatic cSCC). Furthermore, responses continue to remain durable over time.
  • In June 2023, Checkpoint announced that new pharmacokinetic (“PK”) modeling data on cosibelimab supporting the extension to an every-three-week dosing regimen were presented at the Population Approach Group Europe 2023 Annual Meeting. Results support comparability of the cosibelimab 800 mg every-two-week and 1200 mg every-three-week dosing regimens.
  • Throughout 2023 and in January 2024, Checkpoint completed multiple registered direct offerings priced At-the-Market under Nasdaq rules and concurrent private placements of two series of warrants to purchase Checkpoint common stock, for total gross proceeds of approximately $47.6 million. Additionally, in October 2023, Checkpoint announced entry into a definitive agreement for the immediate exercise of warrants for $11.1 million in gross proceeds.
  • In March 2024, Checkpoint announced the appointment of accomplished life sciences executive, Amit Sharma, M.D., FACP, FASN, FNKF, currently Vice President of Clinical Development and Therapeutic Head for Nephrology and Hematology at Alexion, AstraZeneca Rare Disease, as a non-executive director to Checkpoint’s Board of Directors.
Financial Results:

  • Cash Position: As of December 31, 2023, Checkpoint’s cash and cash equivalents totaled $4.9 million, compared to $12.1 million at December 31, 2022, a decrease of $7.2 million. This cash position is not reflective of the registered direct offering that closed in January 2024 for total gross proceeds of approximately $14.0 million.
$18-$19 mil

 
Keep an eye here- I like this Co alot- / been close to buying a few times- completely out of favor sector etc. Earn are good. Nobody cares. These high bond yields ruin the small cap trades---
ONDS Ondas Holdings Inc. .90c

$0.900. 06(+7.59%)10:01 AM 05/01/24
NASDAQ |$USD |Delayed
 
I know this is up alot and normally that would keep us away.

But the stk has been in the dumps an it's break came at $20 level.

so a nice retrace of today's move this week and this can be bought. $15 <-----

TGTX TG Therapeutics, Inc.

$16.34 +2.68(+19.58%)10:29 AM 05/01/24
NASDAQ |$USD |Realtime
 
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