Home > Boards > US Listed > Biotechs > Gamida Cell Ltd. (GMDA)

Gamida: Catalysts Ahead, Looks Interesting

Public Reply | Private Reply | Keep | Last ReadPost New MsgReplies (1) | Next 10 | Previous | Next
midastouch017 Member Profile
 
Followed By 126
Posts 25,638
Boards Moderated 9
Alias Born 02/07/04
160x600 placeholder
Report of Foreign Issuer Pursuant to Rule 13a-16 or 15d-16 (6-k) Edgar (US Regulatory) - 6/25/2021 4:17:04 PM
Gamida Cell Announces Publication in Blood, the Journal of the American Society of Hematology, of the First Pivotal Trial to ... Business Wire - 6/23/2021 7:00:00 AM
Gamida Cell to Present Corporate Highlights at Multiple Investor Conferences in June Business Wire - 6/9/2021 8:00:00 AM
Report of Foreign Issuer Pursuant to Rule 13a-16 or 15d-16 (6-k) Edgar (US Regulatory) - 6/7/2021 7:12:28 AM
Gamida Cell Announces Appointment of Senior Vice President, Global Operations & Manufacturing & Provides Commercial Manufactu... Business Wire - 6/7/2021 7:00:00 AM
Report of Foreign Issuer Pursuant to Rule 13a-16 or 15d-16 (6-k) Edgar (US Regulatory) - 5/21/2021 4:16:42 PM
Gamida Cell to Present at the RBC Capital Markets Global Healthcare Conference Business Wire - 5/12/2021 8:00:00 AM
Report of Foreign Issuer Pursuant to Rule 13a-16 or 15d-16 (6-k) Edgar (US Regulatory) - 5/11/2021 8:29:16 AM
Gamida Cell EPS beats by $0.06 Seeking Alpha - 5/11/2021 7:03:49 AM
Gamida Cell Reports First Quarter 2021 Financial Results and Provides Company Update Business Wire - 5/11/2021 7:00:00 AM
Gamida Cell Announces the Date of Its First Quarter 2021 Financial Results and Webcast Business Wire - 5/4/2021 8:00:00 AM
Gamida Cell to Present at the 20th Annual Needham Virtual Healthcare Conference Business Wire - 4/7/2021 8:00:00 AM
Gamida Cell Presents Efficacy & Safety Results of Phase 3 Study of Omidubicel in Patients with Hematologic Malignancies at th... Business Wire - 3/15/2021 10:24:00 AM
Amended Statement of Beneficial Ownership (sc 13d/a) Edgar (US Regulatory) - 3/11/2021 4:36:22 PM
Prospectus Filed Pursuant to Rule 424(b)(7) (424b7) Edgar (US Regulatory) - 3/11/2021 4:02:23 PM
Amended Annual and Transition Report (foreign Private Issuer) (20-f/a) Edgar (US Regulatory) - 3/11/2021 3:34:31 PM
Notice of Effectiveness (effect) Edgar (US Regulatory) - 3/11/2021 6:04:18 AM
Report of Foreign Issuer Pursuant to Rule 13a-16 or 15d-16 (6-k) Edgar (US Regulatory) - 3/9/2021 4:09:39 PM
Gamida clibs 5.6% despite a Q4 miss, provides 2021 guidance Seeking Alpha - 3/9/2021 11:22:41 AM
Gamida Cell EPS misses by $0.35; outlook Seeking Alpha - 3/9/2021 7:05:01 AM
Gamida Cell Reports Full Year 2020 Financial Results and Provides Company Update Business Wire - 3/9/2021 7:00:00 AM
Gamida Cell to Present at Upcoming Investor Conferences Business Wire - 3/3/2021 7:00:00 AM
Gamida Cell Announces the Date of Its Full Year 2020 Financial Results and Webcast Business Wire - 3/2/2021 7:00:00 AM
Securities Registration (foreign Private Issuer) (f-3) Edgar (US Regulatory) - 3/1/2021 4:40:43 PM
Gamida Cell Announces Results from Phase 3 Study of Omidubicel to be Presented at the 47th Annual Meeting of the European Soc... Business Wire - 3/1/2021 7:00:00 AM
midastouch017   Sunday, 03/07/21 09:32:03 AM
Re: None
Post # of 310 
Gamida: Catalysts Ahead, Looks Interesting

Mar. 07, 2021 9:07 AM ETGamida Cell Ltd. (GMDA)

https://seekingalpha.com/article/4412025-is-gamida-cell-stock-gmda-a-dip-buy-on-upcoming-catalysts

Summary

GMDA addressed its cash issues, but its approval got a little delayed.
That was because the FDA raised manufacturing concerns.
The company seems confident in its ability to address those.
Looking for more investing ideas like this one? Get them exclusively at The Total Pharma Tracker. Learn More »
Gamida Cell (GMDA) is an Israeli company developing an enhanced version of commonly used cord blood HSCT. I covered it in March 2019, when I said that while the low cash position and somewhat obscure nature of the therapy fails to convince us, this is interesting enough to bear watching.

Since I wrote that, Gamida has fallen, and kept on falling; until now. I wrote that on March 12, 2019, when the stock was trading near $12. Right after that, for the entire two years since now, the stock stayed below $12 - indeed, it went down to near penny stock level a few times. However, recently, the stock has seen some movement. It went up to over $11 recently, then fell back to current levels of $8. So we need to see - what changed?

The core value proposition of GMDA is that hematopoietic stem cell transfer or HSCT is curative for a number of cancers, but it has certain limitations. These are basically four - lack of rapid availability due to type mismatch, inefficient engraftment, delayed onset of immune activation leading to infections, and host rejection leading to graft versus host disease or GvHD. GMDA’s nicotinamide-based technology resolves all of these limitations some of the time. Its pipeline looks like this:


Source

The company recently published data from the phase 3 AML trial of lead candidate Omidubicel. The trial compared the time to neutrophil engraftment as the primary endpoint between nicotinamide enhanced ex vivo expanded umbilical cord blood grafts, i.e. Omidubicel, versus standard cord blood, in AML patients. The trial met its primary endpoint successfully and with statistically significant p-value.



Source

In terms of safety, there were fewer viral infections in the drug arm, showing the benefit of Omidubicel. Although Omidubicel did not differentiate itself statistically significantly from standard UBC for GvHD, either grade 2-4 or grade 3-4 at 100 days, there was a noticeable trend in favour of Omidubicel in terms of reduced incidence of GvHD.

The study showed, in summary:

Myeloablative transplantation with omidubicel results in

Faster hematopoietic recovery

Fewer early infections

Fewer days in the hospital

No excessive toxicity associated with omidubicel compared to standard umbilical cord blood transplantation

Durable engraftment >10yrs (earlier studies)

Omidubicel should be considered a new standard of care for patients eligible for umbilical cord blood transplantation

The trial successfully met the primary endpoint, and all three of its secondary endpoints. The prespecified secondary endpoints of the study were the proportion of patients who achieved platelet engraftment by day 42, the proportion of patients with Grade 2 or Grade 3 bacterial or invasive fungal infections in the first 100 days following transplant, and the number of days alive and out of the hospital following transplant.

The company had originally planned to bring the treatment to market this year. However, the FDA recommended that the company generate additional manufacturing- related data prior to requesting a pre-BLA meeting. The company now plans to file the NDA by the second half of 2021, and launch the drug by mid-2022 under a Breakthrough Therapy Designation.

Financials

GMDA has a market cap of $491mn and a cash reserve of $73mn. The company raised $65mn through an offering in December, and another $75mn from Highbridge Capital last month. So they are adequately funded, although they could certainly use more funds.

Bottom Line

HCST is a major market and the only curative approach in a number of cancers. GMDA’s treatment could, in theory and as demonstrated in trials, remove a number of its limitations. Of the four limitations I listed at the beginning, Omidubicel was able to address the first three adequately, and saw trends of betterment of GvHD problems in patients. They are trading a little lower than their recent highs because of diluting their shares, but the dilution was necessary. They are also trading low because of the slight delay in filing and approval. However, manufacturing concerns are quite common for these sorts of therapies, and the company seems confident in its ability to address them. As such, while this is NOT an official buy recommendation, this may be a buying opportunity for those investors with a greater tolerance for risk.



Public Reply | Private Reply | Keep | Last ReadPost New MsgReplies (1) | Next 10 | Previous | Next
Follow Board Follow Board Keyboard Shortcuts Report TOS Violation
X
Current Price
Change
Volume
Detailed Quote - Discussion Board
Intraday Chart
+/- to Watchlist
Consent Preferences