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Gamida Cell Ltd (PK)

Gamida Cell Ltd (PK) (GMDAQ)

0.017
0.00
(0.00%)
Closed May 31 4:00PM

Empower your portfolio: Real-time discussions and actionable trading ideas.

Key stats and details

Current Price
0.017
Bid
0.017
Ask
0.0195
Volume
-
0.00 Day's Range 0.00
0.008 52 Week Range 0.025
Market Cap
Previous Close
0.017
Open
-
Last Trade
Last Trade Time
Financial Volume
-
VWAP
-
Average Volume (3m)
1,639,940
Shares Outstanding
131,932,000
Dividend Yield
-
PE Ratio
-0.06
Earnings Per Share (EPS)
-0.48
Revenue
1.78M
Net Profit
-63M

About Gamida Cell Ltd (PK)

Sector
Biological Pds,ex Diagnstics
Industry
Biological Pds,ex Diagnstics
Headquarters
Jerusalem, Jerusalem, Isr
Founded
1970
Gamida Cell Ltd (PK) is listed in the Biological Pds,ex Diagnstics sector of the OTCMarkets with ticker GMDAQ. The last closing price for Gamida Cell (PK) was $0.02. Over the last year, Gamida Cell (PK) shares have traded in a share price range of $ 0.008 to $ 0.025.

Gamida Cell (PK) currently has 131,932,000 shares outstanding. The market capitalization of Gamida Cell (PK) is $3.96 million. Gamida Cell (PK) has a price to earnings ratio (PE ratio) of -0.06.

GMDAQ Latest News

PeriodChangeChange %OpenHighLowAvg. Daily VolVWAP
10.0016.250.0160.018250.0163327540.017CS
40.0045360.01250.01950.0123847680.01517036CS
12-0.004-19.04761904760.0210.0250.00816399400.01625476CS
26-0.004-19.04761904760.0210.0250.00816399400.01625476CS
52-0.004-19.04761904760.0210.0250.00816399400.01625476CS
156-0.004-19.04761904760.0210.0250.00816399400.01625476CS
260-0.004-19.04761904760.0210.0250.00816399400.01625476CS

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GMDAQ Discussion

View Posts
Renee Renee 1 week ago
GMDAQ: BK PLAN effective. All shares cancelled.

https://otce.finra.org/otce/dailyList?viewType=Deletions

https://otce.finra.org/otce/dailyList?viewType=Deletions
👍️0
Renee Renee 2 months ago
GMDA changed to GMDAQ, bankruptcy. Delisted from the Nasdaq to the OTC. PPS closed at .031 on 22 million volume.

https://otce.finra.org/otce/dailyList?viewType=Additions
👍️0
Strukture Strukture 2 months ago
LOL 🤡
yer a fkn liar .. extended a year is not the same as paid off..

I did say they were extended to 2 years bc there were no default in payments as per my query to him regarding them .. You really are a narcissistic clown..
👍️0
TrendTrade2016 TrendTrade2016 2 months ago
YEAH YA DID...YOU SPOKE TO HIM ON THE PHONE...SHORT TERM MEMORY LOSS...HAVE YOU BEEN TESTED FOR DEMENTIA
👍️0
Strukture Strukture 2 months ago
I never once said anything of the sort that notes paid off you sound like Poilievre stop being a douche.. I said they were extended a year as per a conversation directly w the ceo and no dilution had occurred since I exited my trade nor has there been any to date,,

You can also stop with the CAPS lock like a raging hormonal woman on the rag .. and grow up and mature your narcissistic self before trying to cast stones like a Hypocritical clown..

I entered that trade at 0004 back in January, --

95% of what you trade acts the same way you are in it till your not the market is to be traded I dont invest I swing weekly set-ups mostly .. Maybe one day you'll realize most of your posts are narcissistic and hypocritical and just down right being an ass hole to others,,, But I doubt it your in your 60s you cant help being like DT .. kinda sad
👍️0
TrendTrade2016 TrendTrade2016 2 months ago
I WARNED YOU ...BUT PUMPERS NEVER WANT TO TALK THE TRUTH...MAKING UP LIES ABOUT THE NOTE BEING PAID OFF...SHAME ON YOU....HOW DO YOU LIVE WITH YOURSELF LYING AND PUMPING
👍️0
Strukture Strukture 2 months ago
Don’t pretend to write a narrative about me. When yours is wrought with self-righteousness and narcissism.

👍️0
TrendTrade2016 TrendTrade2016 2 months ago
YOU ALWAYS PUMP AND DUMP AND MAKE EVERYONE WRONG FOR BEING RIGHT
👍️0
Strukture Strukture 2 months ago
I was out with my balance of shares when the longer-term trend turned Bearish but still avgd 150% on all my original shares. It happens

Have a great day bud
👍️0
TrendTrade2016 TrendTrade2016 2 months ago
DAY TRADE SON....LIKE ALL NASY UNDER A DOLLA PLAYS
👍️0
TrendTrade2016 TrendTrade2016 2 months ago
CGAC...SORRY BOUT YOUR BIG BITCOIN PLAY, BUT YOU WERE WARNED MANY TIMES
👍️0
Strukture Strukture 2 months ago
I call BS it tanked a day later! So many small caps are just as bad as a lot of the OTC except they throw offerings and reverse splits and dilution they have more ammunition to fuck traders.
Just sayin.
👍️0
TrendTrade2016 TrendTrade2016 2 months ago
IT WAS GOOD BACK THEN...LOL
👍️0
Strukture Strukture 2 months ago
LOL 🤡
👍️0
steez steez 2 months ago
Looking good got in
👍️0
motleytool motleytool 2 months ago
Capable of way more than 100% from here.
👍️0
motleytool motleytool 2 months ago
Boom!
👍️0
motleytool motleytool 2 months ago
Read the financials. The officers were buying shares right before this announcement. Musk would pull these same stunts to fry the shorts and it always worked.
👍️0
motleytool motleytool 2 months ago
Fasten your seatbelt!
👍️0
motleytool motleytool 2 months ago
There will be a significant spike here. Shorts hammered this after the 150 mil shelf was registered on 12-6-23. They cant take profit unless they cover. They have a shit ton to lose and were banking on the shelf for shares to cover with. Once the company go's private they lose the capital they bet on a short position that cant be covered.
👍️0
ErnieBilco ErnieBilco 2 months ago
Another Israeli run scam by mis-management and Highbridge - When are the exchanges gonna stop allowing these shit shows on the big boards?
👍️0
pacman181 pacman181 2 months ago
Soulless, unreal whay has happened to commons
👍️0
midastouch017 midastouch017 2 months ago
Q4 2023 Gamida Cell Ltd Earnings Call

Participants
Mike Kuczkowski; Corporate Communications; Gamida Cell Ltd

Abigail Jenkins; President, Chief Executive Officer, Director; Gamida Cell Ltd

Terry Coelho; Chief Financial Officer; Gamida Cell Ltd

Presentation
Operator

Ladies and gentlemen, thank you for standing by. Welcome to Gamida Cell's conference call for a business update and fourth quarter and full year 2023 financial results. My name is Daryl, and I'll be your operator for today's call. Please be advised that this call is being recorded at Gamida Cell's request. Now I would like to introduce you to our conference host, Mike Kuczkowski of Gamida Cell Corporate Communications. Mike, please go ahead.

Mike Kuczkowski

Thank you, Daryl, and good morning, everyone. Welcome to today's call, during which we will provide an update on the company and review our financial results for the fourth quarter and full year 2023. Earlier this morning, we issued two press releases. One announcing the commencement of a restructuring process supported by Highbridge Capital Management, and the other summarizing our financial results and providing a business update. Both press releases are available at our website, www.gamida-cell.com. Please note, we will not be hosting a question-and-answer session on today's call. Here with me on our call today are Abbey Jenkins, Gamida Cell's President and Chief Executive Officer; and Terry Coelho, our Chief Financial Officer.
Before we begin, I want to remind everyone that during this call, we may make forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any statement describing Gamida Cells goals, expectations, financial, or other projections, intentions, or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements, including those with respect to the curative, therapeutic, and commercial potential of Omisirge, omidubicel-onlv, Gamida Cell's cell therapy candidate, GDA-201, the continued commercialization of and patient access to Omisirge, the financial runway of Gamida Cell, Gamida Cell's ability to complete a transaction supported by Highbridge pursuant to the restructuring support agreement, Gamida Cell's ability to secure the Israeli court's approval of the transaction, Gamida Cell's expectations regarding the delisting from NASDAQ and the timing of the completion of the restructuring proceedings, and the state of Gamida Cell's workforce are subject to a number of risks, uncertainties, and assumptions.
These risks, uncertainties, and assumptions include those relating to clinical, scientific, regulatory, and technical developments and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics, and that's through the pursuit of the transactions contemplated under the RSA, the risk that no transaction may result.
In light of these risks and uncertainties and other risks and uncertainties that are described in the risk factors section and other sections of Gamida Cell's annual report on Form 10-K to be filed with the Securities and Exchange Commission on March 27, 2024 and other filings that Gamida Cell makes with the SEC from time to time, which are available at www.sec.gov. The events and circumstances discussed in such forward-looking statements may not occur and Gamida Cell's actual results could differ materially and adversely from those anticipated or implied, thereby. Although Gamida Cell's forward-looking statements reflect the good-faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell. As a result, you're cautioned not to rely on these forward looking statements.
Now, I will turn the call over to Gamida Cell's President and CEO, Abbey Jenkins.

Abigail Jenkins

Thank you, Mike, and everyone joining us today. In this past year, Gamida Cell has achieved important milestones, most notably our long-standing goal of bringing Omisirge to the FDA approval process as the only stem cell therapy approved on the basis of a global randomized Phase 3 clinical trial. As you will hear on today's call, patients continue to receive Omisirge as we onboard more transplant centers. We are gratified that Omisirge is available as a potentially life-saving option for patients with hematologic malignancies in need of a stem cell transplant. For these patients, Omisirge may represent their last, or best, cure, and we are proud to be able to continue to serve our patients.
We have also had to overcome many challenges in this process, including achieving long-term financial stability for the company. Today, I'm providing a corporate update and outlining the progress we've made to stabilize Gamida Cell's financial foundation. As you know, in Q2 2023, we initiated a strategic restructuring and engaged in an extensive process to pursue strategic alternatives to support the commercialization of Omisirge. Our initial strategic alternatives review process, included outreach to numerous potential strategic partners, including large and midsized pharmaceutical companies and we engaged in substantial discussions with many of those parties. Despite this effort, we did not identify a partnership that would adequately address our strategic needs by the end of the year.
In January, we redoubled our efforts and announced that we were focused on reaching a transaction that would provide the long term financial runway necessary for Gamida Cell to commercialize Omisirge, specifically pursuing a merger acquisition or asset sale. Through that process, we engaged with a number of parties, some as reengagement and others new. However, these efforts did not yield any actionable alternatives.
Earlier today, we announced that we have entered into a restructuring support agreement with Highbridge Capital Management, our principal lender. Under the terms of the agreement and upon completion of our restructuring process, Highbridge will convert $75 million of its existing unsecured convertible senior note into all of the equity in the company. The Company will receive $30 million of new capital from Highbridge on the effective date of the restructuring. Highbridge is also expected to invest significant additional capital following the company's emergence. Gamida Cellwill become a private company, wholly owned by Highbridge and the company's outstanding ordinary shares will be canceled. Current ordinary shareholders of Gamida Cell are expected to receive a contingent value right with a potential aggregate maximum value of $27.5 million, subject to the achievement of certain revenue and regulatory milestone within specified timeframe.
This restructuring transaction will enable Gamida Cell to remain a going concern and will support our ongoing efforts to make Omisirge available to more transplant centers and their patients. Gamida Cell's Board of Directors has determined that this transaction is the best path forward at this time to maintain patient access to Omisirge.
As a next step, Gamida Cell will begin a voluntary Israeli restructuring proceeding. We expect the transaction will close in the second quarter of 2024, following approval by the Israeli court. Once it closes, Gamida Cell will become a privately held company, fully owned by Highbridge, and will be de-listed from the NASDAQ. In parallel, we will be implementing a headcount reduction of approximately 25% of our team, to rightsize operations to align with the current business conditions and our focus on Omisirge commercialization. Also, Gamida Cell is finalizing the wind down of its Jerusalem office and consolidating all Israeli operations into our state-of-the-art manufacturing facility in Kiryat Gat.
Two key executives will be moving on from the company, Chief Commercial and Operating Officer, Michele Korfin, will depart the company on April 1; and General Counsel and Chief Compliance Officer, Josh Patterson, will depart the company on April 26. I would like to thank Michele and Josh for their years of dedication and service to Gamida Cell and their commitment to our patients. Their leadership and guidance have been instrumental in achieving the approval and commercialization of Omisirge, and we wish them well in their next endeavors.
In a similar way, I want to thank everyone on the team with whom we've had to make the difficult decision to part ways. These are extremely talented individuals who have been the driving force behind our ability to deliver unmanned modified cell therapy to patients. Even during challenging times in the biotech market, especially over this past year, I have witnessed this team's resilience. Faced with a delay of our date for Omisirge, the team rallied to deliver what was needed to secure approval in April. When it was eventually approved two weeks early, the team rallied again to ensure Omisirge was immediately available to transplant centers and patients.
In the face of the Israel-Hamas war, this team again showed courage and commitment, maintaining our operations without interruptions. Time and time again, this team has put patients first, and I could not be prouder of what we have accomplished. For those moving on, I have no doubt they will continue to bring positive change for patients in their future endeavors, and we will do whatever we can to support their transitions to new positions in the industry. Any company would be lucky to have these talented individuals as part of their team.
Shifting gears for a few minutes into commercial and medical updates. I would like to walk through where we ended the year against our 2023 goal. We onboarded a total of 17 transplant centers, exceeding the top end of the goal of 10 to 15 for the year. Omisirge has confirmed coverage with US payers covering more than 90% of commercial lives, exceeding our full-year goal of 70%. This includes covered -- confirmed coverage with all of the top 20 US commercial payers. Omisirge also has confirmed Medicare coverage and reimbursement. We reported revenue from the delivery of six units of Omisirge in 2023, including four units in the fourth quarter, meeting our goal of delivering a total of four to six units of Omisirge for the year. As of today, three units of Omisirge have been delivered this year, and we have a total of 24 transplant centers onboarded where patients can access Omisirge.
In addition, today, we announced the results from 13 patients in our Phase 1 dose escalation clinical trial of GDA-201. There were no dose-limiting toxicities and no GDA-201 related grade three or four adverse events. Efficacy evaluation showed three patients with complete response, two with partial response, and two with stable disease. You can see the details of these results in our press release. These data offer positive signals about the potential anti-tumor activity for GDA-201. Gamida Cell does not plan to conduct further development of GDA-201 at this time.
Going forward, our executive team, including myself; Terry Coelho, who has agreed to continue as Chief Financial Officer through June 2024; Ronit Simantov, our Chief Medical and Scientific Officer; and Penny Bushell, our Chief Human Resources Officer, will continue to manage the business, focused on supporting the continued uptake of Omisirge with transplant centers and patients.
I will now turn the call over to Terry to provide a financial update and additional details about our restructuring process. Terry, over to you.

Terry Coelho

Thank you, Abbey, and good morning, everyone. I will begin by sharing more information about the restructuring process supported by Highbridge Capital Management that we announced earlier today. Through this process, Highbridge will convert all $75 million of existing unsecured convertible senior notes into equity, which will represent 100% of the outstanding equity in the newly reorganized company. This transaction will reduce Gamida Cell's outstanding debt by $75 million and annual interest expense by $4.4 million. The company will receive a secured debt facility of $50 million, of which approximately $5 million will be the remaining principal amount due on Gamida Cell's existing secured convertible senior notes.
Now turning to results. 2023 represented our first year as revenue generating company. As Abbey mentioned, we reported revenue from the delivery of six units of Omisirge in 2023, including four units in the fourth quarter, meeting our goal for the year. As we shift from a clinical stage company to a commercial stage company, certain reclassifications of spend were incorporated into our financial reporting beginning in the third quarter of 2023. I will point out the key changes as we walk through the financial results.
In the fourth quarter ended December 31, 2023, we are reporting net revenue of $1.1 million, resulting from the delivery of the four units of Omisirge. Full year 2023 net revenue was $1.8 million, resulting from the delivery of six units of Omisirge. Full year 2023 cost of sales, including cost of direct manufacturing and quality in addition to royalty expenses and that shows your costs where applicable was $1.5 million for full year 2023, resulting in 18.5% gross margin for the year. Overtime, we expect the cost of sales and therefore the gross margin improved measurably as production volumes scale to capacity.
Beginning July 1, 2023, the reporting of operating expenses has been modified to reflect the company's transition to commercial stage, with all operating expenses being reported as either research and development expenses, excess capacity, or selling, general, and administrative or SG&A expenses. For 2022, and the first two quarters of 2023, previously reported commercial and general and administrative costs were combined into SG&A expenses. Additionally, certain expenses previously recorded in research and development are now being reported in SG&A beginning in the third quarter of 2023, with no reclassification of prior periods.
Research and development expenses were $24.3 million for the 12 months ended December 31, 2023, compared to $42.7 million in 2022. The decrease of $18.4 million was due primarily to the aforementioned reporting transition, along with reduced omidubicel clinical spend relating to the winding down of the Phase 3 clinical trial and reduced NK platform clinical and research and development spend. Excess capacity costs were $4.1 million in 2023, reflecting costs associated with labor, manufacturing, overheads, and manufacturing depreciation above our standard cost of goods, which are based on staffed capacity levels.
SG&A expenses were $44.6 million in 2023, an increase of $12.3 million compared to 2022. The aforementioned financial reporting transition, which resulted in the inclusion of medical affairs, expenses, and certain indirect supply chain and quality assurance expenses in SG&A reporting, contributed approximately $6.9 million to the increase in 2023 as compared to 2022. Selling and marketing expenses increased by $4.3 million compared to the prior year due to commercial launch activities. General and administrative expenses increased by approximately $1.1 million in 2023 as compared to 2022.
Financial income or expenses net were $10 million of income in 2023 compared to $4.4 million of expense in 2022. The $14.4 million change in financial income was primarily due to $17.5 million of non-cash income related to the valuation of warrants liability, partially offset by $1.9 million of higher interest expenses, $600,000 of non-cash loss related to the valuation of the company's secured convertible senior notes issued in December 2022, and $0.5 million of lower interest income.
Our net loss was $63 million in 2023 compared to a net loss of $79.4 million in 2022, with the lower net loss being driven primarily by the increase in financial income of $14.4 million, together with approximately $2 million of lower operating expenses. In the fourth quarter of 2023, our net loss was $8.8 million compared to a net loss of $22.8 million in the fourth quarter of 2022, primarily driven by the increase in financial income of $10 million, together with approximately $4 million of lower operating expenses.
As of December 31, 2023, Gamida Cell had total cash and cash equivalents of $46.6 million compared to $64.7 million as of December 31, 2022, to the decrease of $18.1 million is due primarily to $61.8 million in net cash proceeds from financing activities, which was comprised of $21.1 million in net proceeds from the issuance of ordinary shares and warrants from the company's underwritten public offering in April 2023 and $43.1 million in net proceeds from the issuance of ordinary shares via the at the market or ATM facility, offset by $2.2 million in principal payments of the company's 2022 convertible senior note and $79.1 million of net cash used in operating activities.
As of March 15, 2024, for our preliminary estimated unrestricted cash and cash equivalents balance was $28.5 million. Although it is difficult to predict future liquidity requirements, we believe that our current total existing funds will not be sufficient to support our ongoing operating activities, including the restructuring process through the end of the second quarter of 2024.
Finally, with regard to our debt position, as of December 31, 2023, the company had reduced its principal balance on the 2022 secured convertible note by $18.4 million from $25 million as of December 31, 2022, $6.6 million at the end of the fourth quarter of 2023. The company also holds a 2021 convertible senior note with an aggregate principal amount of $75 million.
With that, I will turn the call back over to Abbey for some concluding remarks. Abbey?

Abigail Jenkins

Thank you, Terry. Today, we discussed several important business updates, most notably, the decision to enter into a restructuring support agreement with Highbridge Capital. The transaction allows Gamida Cell to continue as a going concern and to focus on commercializing Omisirge as we develop and deepen our relationships with transplant center partners to increase access to Omisirge. Going forward, we will be a leaner, more focused organization and with a more stable financial foundation. Gamida Cell will be positioned to continue delivering this potentially life-saving cell therapy for patients with hematologic malignancies, including those from diverse backgrounds.
I want to once again thank our employees and express our gratitude to our transplant center partners and vendors for their support through this time of uncertainty as we continue to advance the commercialization of Omisirge. We continue to believe in the future of Gamida Cell and are grateful that Omisirge is available for the patients that need it most.
Thank you, everyone, for joining us on the call today. Operator, back to you.

Operator

Thank you. That does conclude today's teleconference. We appreciate your participation. You may disconnect at this time. Enjoy the rest of your day.
👍️0
midastouch017 midastouch017 2 months ago
The company will be removed from the listing,
shareholders will probably receive a few pennies
per share at best.
👍️0
Itstime15 Itstime15 2 months ago
What is the meaning of the company going private? What happens to shareholders?
👍️0
midastouch017 midastouch017 2 months ago
You answered your question.
👍️ 1
DeafTrader2 DeafTrader2 2 months ago
Gamida Cell will become a private company, wholly owned by Highbridge, and the company’s outstanding ordinary shares are expected to be canceled.
👍️0
midastouch017 midastouch017 2 months ago
Only if you have throw-away monies.
👍️0
DeafTrader2 DeafTrader2 2 months ago
Shall we buy this where ppl are fearful ?
👍️0
midastouch017 midastouch017 2 months ago
Announcing the death of my dream.
👍️0
murocman murocman 2 months ago
This is a text book case of what horrible, incompetent management can do to an otherwise good product/idea.

What an awful turn of events 🤬
👍️0
midastouch017 midastouch017 2 months ago
Gamida Cell to Report Fourth Quarter and Full-Year 2023 Financial Results

https://finance.yahoo.com/news/gamida-cell-report-fourth-quarter-120000352.html

BOSTON, March 22, 2024 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that the company will release its financial results for the fourth quarter and full year ended December 31, 2023 and provide an update on the company on Wednesday, March 27, 2024.

Following the release, management will host a conference call and live webcast at 8:30 AM Eastern Time to discuss the financial results and provide a business update.

Conference Call Dial-In & Webcast Information:

Date/Time:

Wednesday, March 27, 2024 at 8:30 AM Eastern Time

Domestic:

1-877-425-9470

International:

1-201-389-0878

Conference ID:

13744446

Call me™:

Click here.

Webcast:

Click here.





A replay of the webcast will be available on the Company’s website. approximately two hours after the event, for approximately 30 days.

About Gamida Cell

Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include Omisirge® (omidubicel-onlv), an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, X, Facebook or Instagram.

Omisirge® is a registered mark of Gamida Cell Inc. © 2024 Gamida Cell Inc. All Rights Reserved.


Investor Contacts:
Chuck Padala
LifeSci Advisors
chuck@lifesciadvisors.com
1-646-627-8390

Media Contact:
Dan Boyle
Orangefiery
media@orangefiery.com
1-818-209-1692
👍️0
Monksdream Monksdream 2 months ago
Not every company is destined to be the next Microsoft
👍️0
vintagesake vintagesake 2 months ago
BK or BO...that's the question to be answered...
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Monksdream Monksdream 2 months ago
GMDA 10Q due 3/22
👍️0
TrendTrade2016 TrendTrade2016 2 months ago
GMDA...HERE WE GO
👎️ 1
TrendTrade2016 TrendTrade2016 2 months ago
GMDA...MINI MONSTER READY TO BLOW OUT THE 40C TRIGGER
👍️0
TrendTrade2016 TrendTrade2016 2 months ago
GMDA...HERE WE GO...40C TRIGGER UP A HEAD
👍️0
TrendTrade2016 TrendTrade2016 2 months ago
GMDA..HERE WE GO
👍️0
TrendTrade2016 TrendTrade2016 2 months ago
GMDA...VOLUME AND JIGGY
👍️0
midastouch017 midastouch017 3 months ago
***Correction***

Completely disappointed!
👍️0
midastouch017 midastouch017 3 months ago
The market is clearly unimpressed!
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midastouch017 midastouch017 3 months ago
Gamida Cell Data Presented at the 2024 Tandem Meetings of ASTCT® and CIBMTR®

https://finance.yahoo.com/news/gamida-cell-data-presented-2024-130000249.html

Expanded access program (EAP) data for omidubicel are consistent with Phase 3 trial results on rates of hematopoietic recovery and infections following stem cell transplant with Omisirge® (omidubicel-onlv)

Preliminary data presented on GDA-201, Gamida Cell’s natural killer (NK) cell therapy candidate in ongoing Phase 1 study for non-Hodgkin lymphoma, show promising early evidence of anti-tumor activity

BOSTON, Feb. 23, 2024 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today presented data highlighting its expanded access program (EAP) for FDA-approved allogeneic stem cell therapy Omisirge® (omidubicel-onlv) and Phase 1 data for its allogeneic cryopreserved natural killer (NK) cell therapy candidate GDA-201 at the 2024 Tandem Meetings, Transplantation & Cellular Therapy (TCT) Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR). The hybrid meetings take place February 21-24 virtually and in person in San Antonio, Texas.

“The data presented at Tandem provide further evidence of the potential of Gamida Cell’s nicotinamide (NAM) technology to develop potentially curative therapies by expanding and enhancing cells,” said Ronit Simantov, MD, Chief Medical and Scientific Officer of Gamida Cell. “The EAP study provided the opportunity to treat patients after completion of enrollment of the Phase 3 trial and prior to the approval of Omisirge. It allowed for institutional variability in conditioning regimens and supportive care, more closely reflecting the real-world environment. Data were consistent with previous studies, showing that patients transplanted with omidubicel had rapid hematopoietic recovery and a low rate of serious infections post-transplant.”

“The Phase 1 data on our natural killer (NK) cell candidate GDA-201 further support the anti-tumor activity of our NAM-enhanced cellular therapy, and today marked the first presentation of study results using our cryopreserved, readily available formulation,” Simantov added.

Reporting on omidubicel’s EAP data, principal investigator Mitchell E. Horwitz, MD, Stem Cell Transplant Specialist and Professor of Medicine at Duke Cancer Institute, said, “I am highly encouraged by the results in the omidubicel expanded access program. The potential for rapid hematopoietic recovery post-transplant observed with omidubicel could make a meaningful impact on patient health. I am pleased to see that the EAP results are consistent with data from the Phase 3 study.”

Additional details on the presentations are as follows:

Title: Omidubicel-onlv for Allogeneic Transplantation (allo-HCT) in Patients with Hematologic Malignancies: Results of a Multicenter Open-Label Expanded Access Program (EAP)
Abstract Number: 313
Lead Author: Mitchell E. Horwitz, MD, Stem Cell Transplant Specialist and Professor of Medicine at Duke Cancer Institute
Time: February 22, 6:45-7:45 p.m. CT

Presentation highlights: In this expanded access program (EAP) evaluating outcomes in 29 patients with hematologic malignancies following allogeneic hematopoietic stem cell transplant with omidubicel, outcomes were overall consistent with those from omidubicel’s Phase 3 study. Eligible patients =12 years of age received myeloablative conditioning, prophylactic medications and supportive care per individual institutional standards. Median time to neutrophil and platelet engraftment were 12 and 34 days, respectively. Results were also similar to the Phase 3 study for infection (first grade 2-3 bacterial / invasive fungal infections at 100 days posttransplant: 18%), graft-versus-host-disease (grades 3-4: 19%), disease-free survival (79%) and overall survival (87%). Demographics of transplanted patients were 55% White, 21% Asian, 17% Black, and 7% other, consistent with the Phase 3 trial, in which >40% of the study participants were racially or ethnically diverse. Omidubicel was approved under the brand name Omisirge® (omidubicel-onlv) by the U.S. FDA in April 2023 for allogeneic stem cell transplant.

Title: A Phase I/II Study of GDA-201, Cryopreserved Nicotinamide-Enhanced Allogeneic Natural Killer Cells, in Patients with Relapsed/Refractory B-cell Lymphoma
Abstract Number: 255
Lead Author: Brian C. Shaffer, Associate Professor of Medicine and Head of the Adult Mismatched Donor Sub-Program at Memorial Sloan Kettering Cancer Center in New York
Date and Time: February 22, 6:45-7:45 p.m. CT

Presentation highlights: In this ongoing multicenter Phase 1 study of allogeneic cryopreserved NK cell therapy candidate GDA-201 in patients with relapsed/refractory B-cell CD20 positive non-Hodgkin lymphoma, preliminary data for the first 12 patients were presented. Patients were heavily pretreated with a median of six prior lines of therapy including CAR-T cell therapy and hematopoietic stem cell transplant. Patients were treated with doses up to 2x108 cells/kg GDA-201 in combination with rituximab. There were no infusion reactions, dose-limiting toxicities or related serious adverse events. Seven patients exhibited a decrease in tumor burden. Efficacy evaluation using Lugano criteria showed three patients with complete response, two with partial response and two with stable disease. Cytokine release syndrome was reported in two patients (grade 1 and grade 2, respectively). There were no cases of immune effector cell associated neurotoxicity syndrome or graft versus host disease reported. Treatment and evaluation of patients in the fourth cohort of the study at the highest dose level of 2x108 cells/kg is ongoing. Full results are expected in Q1 2024.

Posters are available at: https://www.gamida-cell.com/our-rd/
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midastouch017 midastouch017 3 months ago
Gamida Cell Ltd (NASDAQ:GMDA), a biotech player known for pioneering advancements in cell therapy, recently made headlines by announcing its pursuit of strategic alternatives including a possible outright sale. This announcement has sparked a flurry of speculation and interest among investors as the company explores options ranging from asset sales to mergers or other significant strategic transactions. Let us delve into the intricacies of Gamida Cell's current position, evaluating its investment potential against the backdrop of its pioneering technology, market dynamics, and the inherent risks and rewards of biotech investment.

https://smallcapsdaily.com/is-gamida-cell-up-for-grabs-inside-the-biotech-giants-surprising-move-towards-a-potential-sale/

What Does Gamida Cell Do?
Gamida Cell Ltd. is at the forefront of developing innovative cell therapies aimed at treating blood cancers and serious blood diseases. The company's flagship product, omidubicel, has demonstrated promise by successfully completing a Phase III clinical trial for patients suffering from hematologic malignancies. Additionally, omidubicel is making strides in Phase II clinical trials targeting severe aplastic anemia. Beyond omidubicel, Gamida Cell is advancing its portfolio with GDA-201, a pioneering NK cell-based cancer immunotherapy currently undergoing Phase I/II clinical studies. This therapy represents a hopeful advancement for individuals battling relapsed or refractory non-Hodgkin lymphoma and multiple myeloma, showcasing Gamida Cell's dedication to leveraging cell therapy technologies in the fight against cancer.

Successful Commercial Launch & Market Penetration of Omisirge
The successful commercial launch and widespread market adoption of Omisirge represent a pivotal driver for Gamida Cell getting acquired in the near future. Omisirge, a pioneering FDA-approved nicotinamide-modified cell therapy, has marked a significant milestone by transitioning Gamida Cell into a commercial-stage company. The therapy's unique positioning as the first and only approved product of its kind based on a global, randomized Phase III trial has been underscored by the rapid onboarding of 17 transplant centers, surpassing the year's target. This achievement, coupled with confirmed coverage for over 90% of commercial lives in the U.S., including all top 20 commercial payers, showcases the product's strong market acceptance and potential for revenue generation. The company's strategic focus on expanding patient access through a lean launch model, prioritizing resources towards the commercialization of Omisirge, and navigating the complexities of delivering a life-saving therapy amidst the challenges posed by the geopolitical situation in Israel further highlights the company's resilience and commitment to meeting unmet medical needs. As Gamida Cell continues to navigate the initial phases of Omisirge's launch, the therapy's ability to address critical gaps in stem cell transplantation could significantly impact the company's financial performance and stock valuation.

Strategic Partnerships & Financial Stability
The pursuit of strategic partnerships and the achievement of financial stability are critical for Gamida Cell's continued growth and commercial success. Despite the promising launch of Omisirge, Gamida Cell acknowledges the necessity of securing additional funding and establishing strategic partnerships to support the full-scale commercialization of its flagship product. The company's proactive business development activities, facilitated by Moelis & Company, have garnered considerable interest, leading to oral and written proposals from potential partners. However, finding a partnership that fully meets Gamida Cell's strategic needs remains a challenge. The approval of an increase in authorized share capital at the recent Annual General Meeting of Shareholders provides Gamida Cell with enhanced flexibility to finance operations and pursue potential transactions. This strategic maneuvering is crucial for extending the company's cash runway and ensuring that it has the necessary capital to execute its two-pronged strategy of launching Omisirge in the U.S. and seeking a strategic partner for fully resourced commercialization. The ability to secure a suitable partnership and maintain financial health will be instrumental in sustaining the company's momentum and supporting its ambitious goals.

Expansion of the Product Pipeline and R&D Success
Gamida Cell's ongoing research and development (R&D) efforts, particularly around GDA-201, an investigational NK cell-based cancer immunotherapy, represent a significant growth opportunity for potential acquirers. The preliminary data from the Phase I study of GDA-201 in patients with CD20-positive non-Hodgkin lymphoma have shown encouraging results, with no dose-limiting toxicities and marked shrinkage of target lesions observed in a subset of patients. These results, particularly the complete responses seen in some patients, underscore the potential of GDA-201 as a novel therapeutic option for relapsed or refractory lymphoma. The advancement of GDA-201 through clinical development, coupled with the continued exploration of the NAM technology platform, highlights Gamida Cell's commitment to innovation and its potential to diversify and strengthen its product portfolio. The successful development and eventual commercialization of additional therapies like GDA-201 could significantly enhance Gamida Cell's market position, attract investment, and drive long-term growth. As the company progresses with its R&D initiatives, the expansion of its product pipeline will be a critical driver of its future success, potentially catalyzing stock performance as milestones are achieved and new therapies are brought to market.

Final Thoughts

As we can see above, Gamida Cell’s stock has lost a lot of value over the past 6 months which is why the company is trading at a forward EV/ Sales multiple of 5.95x making it a viable acquisition target. It is important to note that amidst this strategic evaluation, the focus remains on the commercialization of Omisirge which is the only one of its kind, offering a novel donor source for allogeneic stem cell transplant, marking a significant milestone in the treatment of various diseases. This could also make it a good target for large pharma. Despite having its fair share of risks, we believe that Gamida Cell could prove to be an interesting high-risk-high-return play for M&A investors.
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glenn1919 glenn1919 3 months ago
GMDA........................................https://stockcharts.com/h-sc/ui?s=GMDA&p=W&b=5&g=0&id=p86431144783
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glenn1919 glenn1919 4 months ago
GMDA...........................https://stockcharts.com/h-sc/ui?s=GMDA&p=W&b=5&g=0&id=p86431144783
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midastouch017 midastouch017 4 months ago
0.3773+0.0287 (+8.2329%)
As of 09:53AM EST. Market open.
Another spin?
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midastouch017 midastouch017 4 months ago
Today is #WorldCancerDay & the last year of the Union for International Cancer Control ( @beach #CloseTheCareGap campaign. Gamida Cell recognizes the importance of helping to increase equitable access to cancer care.

Learn more: https://worldcancerday.org/about-us
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midastouch017 midastouch017 4 months ago
.... and yet another day of sweet nothing
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midastouch017 midastouch017 4 months ago
Playing Games or Signs of Essence?
0.4230 +0.03 (+6.87%)
Pre-Market: 05:03AM EST
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