- We are circling back on Gamida Cell. The stock has had a roller coaster ride since we last highlighted it in October.
- The company has recently addressed its funding needs.
- We update our investment thesis on this small cell therapy concern to account for recent news below.
- I do much more than just articles at The Busted IPO Forum: Members get access to model portfolios, regular updates, a chat room, and more. Learn More »
In England, the struggle between church and kings would take centuries to resolve. Interestingly, in the end, neither institution came out on top. Today, each is as powerless as the other. As people power emerged, we invented politicians. We're not bright.― Jodi Taylor, A Symphony of Echoes
It is time to revisit Gamida Cell (NASDAQ:GMDA). The stock shot straight up after we first profiled it in late October. However, the shares have come back down to earth due to recent weakness in the sector and after its did a couple of capital raises. We update our investment thesis on Gamida below to account for all the major news of the past few months.
Gamida Cell Ltd. (GMDA) is based in Israel and is a clinical stage or 'Tier 4' cell therapy concern. The company is focused on developing treatments for blood cancers and serious blood disorders. The stock currently sells for just north of $8.00 a share and sports an approximate market capitalization of $500 million.
The company develops candidates for its pipeline using its proprietary platform that allows it to expand multiple cell types — including stem cells and natural killer or NK cells — while maintaining their original phenotype and potency. The company has two assets in the clinic undergoing evaluation for three indications.
The most advanced candidate the company is developing is omidubicel which is a combination of NAM-expanded hematopoietic stem cells and differentiated immune cells that is being evaluated in patients in need of hematopoietic stem cell transplantation or HCST. The company disclosed encouraging Phase 3 trial results in May of last year and then disclosed more encouraging results from that trial in October as well as in February. Omidubicel has both Orphan Drug and Breakthrough Therapy designations for this indiciation.
Gamida is currently in the application process (see next section) for this indication. As noted in our last article on Gamida, Piper Jaffray has estimated omidubicel will see peak sales north of $450 million, 6-7 years after launch. Omidubicel is also in much earlier stage development to treat Severe Aplastic Anemia.
The other current drug candidate in Gamida's pipeline is GDA-201. This NAM-based immunotherapy is currently being evaluated in Phase 1 study for the treatment of relapsed or refractory non-Hodgkin’s lymphoma (NHL) and multiple myeloma [MM]
A few notable developments have happened around Gamida since we posted our first profile of it four months ago. In mid-December the company announced that its rolling application for omidubicel won't happened by yearend 2020 as the company had hoped, based on FDA feedback. That application will now be filed in the second half of this year, this pushes back potential commercialization into 2022. A few days later, the company executed a secondary offering at $8.00 per share to raise approximately $65 million. This was followed by another capital raise two months later, this time involving exchangeable senior notes that raised an additional $75 million.
Analyst Commentary & Balance Sheet
The company has seen quite a bit of analyst action since our article of October 27th. On December 16th, RBC Capital reiterated its $12 price target and Buy rating on Gamida. Then following the trial news of February 9th, five analyst firms including Needham and Oppenheimer reissued Buy ratings. Price targets proffered within those ratings ranged between $17.00 to $27.00 a share. Three of those analyst ratings contained significant upward price target revisions.
Here is the commentary from Piper Sandler's analyst who boosted his price target from $13 to $25 on GMDA.
The analyst is citing the company's Phase 3 omidubicel data presented at the TCT Annual Meeting that showed "significantly lowered rate of serious infection" and reduced hospital stay. The analyst adds that along with less stringent HLA matching requirements, omidubicel can dramatically expand access and improve outcomes for HSCT patients, further stating that he is increasing his modeled value on omidubicel to $793 million from $550 million."
Gamida ended the third quarter with just over $70 million in cash and marketable securities on its balance sheet after posting a net loss of just under $15 million. With its two capital raises since then and assuming a similar quarterly burn rate, Gamida should have proforma cash on its balance at the end of FY2020 of between $185 million to $190 million, which means it is well funded to its gets to the commercialization phase and launch of omidubicel
While up substantially since our last piece on the company, the shares of Gamida are off more than a third from recent highs. While having the BLA submission for omdubicel being moved back approximately six months was a disappointment, the company has addressed its funding concerns.
The shares also enjoyed strong analyst support and look undervalued just for the long term potential of omidubicel in HCST. I used this week's weakness in the biotech sector and the recent sell-off in the stock, to add some exposure to my holdings in GMDA. I did via a simple covered call strategy utilizing the September $7.50 call strikes. Options are both liquid and lucrative at that call strike. In addition, there are no major catalysts (outside a partnership deal or buyout) on the horizon until the BLA for omidubicel happens sometime in the second half of this year.
I do not follow politicians on Twitter; if they want to lie to me, it will cost them a stamp.”― Carmine Savastano
Bret Jensen is the Founder of and authors articles for the Biotech Forum, Busted IPO Forum, and Insiders Forum
Author's note: I present and update my best small-cap Busted IPO stock ideas only to subscribers of my exclusive marketplace, The Busted IPO Forum. Our model portfolio has substantially beaten the return of the Russell 2000 since its launch in the summer of 2017. To join the Busted IPO Forum community, just click on the logo below.
This article was written by
The Busted IPO Forum is an investing group led by Bret Jensen, Chief Investment Strategist of Simplified Asset Management. Along with his team of analysts, Bret focuses on stocks that have been public for 18 months to 6 years, and that are significantly under their offering price.
The Busted IPO Forum: A model stock portfolio of attractive busted IPOs, trade alerts, deep dive analysis, a weekly option play idea and live chat.
Analyst’s Disclosure: I am/we are long GMDA. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.