I have had no big expectations from todays report,
hence imho sp will further stagnate.
Gamida Cell Reports Second Quarter and First Half 2023 Financial Results and Provides Company Update
Strong start for Omisirge® (omidubicel-onlv) launch with significant payer coverage and number of transplant centers onboarded exceeding expectations
Company continues to pursue strategic partnership to further support Omisirge launch (so in fact nothing new)
Cash runway extended into Q2 2024; balance sheet strengthened with $9 million reduction in debt
Company to host conference call today at 8:30 a.m. ET
BOSTON, August 14, 2023--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today provided a business update and reported financial results for the quarter ended June 30, 2023.
"Since the approval of Omisirge in April, Gamida Cell has made excellent progress on the launch," said Abbey Jenkins, President and Chief Executive Officer of Gamida Cell. "We have rapidly confirmed significant payer coverage and are seeing high interest from transplant centers, exceeding our plans. This is a testament to the unmet needs that Omisirge has the potential to address for patients, as well as the exceptional work of our experienced cell therapy team. We continue to progress our discussions in our efforts to secure a strategic deal to fully resource our Omisirge commercial efforts. We are optimistic that between our progress on the Omisirge launch and our discussions with potential partners, we can accelerate efforts to expand patient access to Omisirge."
The U.S. Food and Drug Administration (FDA) approved Omisirge in April 2023 for use in adult and pediatric patients 12 years and older with hematologic malignancies planned for umbilical cord blood transplantation. The Omisirge launch is ahead of expectations in terms of both transplant center onboarding and market access, with 12 transplant centers already onboarded, eight more in the onboarding process, and active engagement with virtually all of the top 70 transplant centers. The company has also confirmed coverage with payers that cover more than 85% of commercial lives, as well as confirmed coverage and reimbursement with Medicare from the Centers for Medicare and Medicaid Services (CMS). All documents are in place for coverage under the Department of Veterans Affairs, Department of Defense and Medicaid.
"We are very encouraged by the strong interest we have received from transplant centers to date, including centers that did not participate in our clinical studies," said Michele Korfin, Chief Operating and Chief Commercial Officer of Gamida Cell. "The enthusiasm for Omisirge is consistent with expectations from the market research we conducted both pre- and post-approval, supporting our assertion that Omisirge has the potential to capture approximately 20% peak market share. We anticipate this peak share will include patients who might have been otherwise transplanted with a different donor source, as well as patients who historically would not have been able to find an appropriate donor. We have onboarded more centers at this point in our launch than we initially anticipated and are ahead of our expectations in terms of payer coverage. We look forward to engaging with and onboarding additional transplant centers in the coming months to provide more access to Omisirge for patients."
Second Quarter Highlights and Recent Developments
The company is seeing strong demand from transplant centers and is ahead of its goal of onboarding 10-15 transplant centers in 2023. As of the morning of August 14, 2023, 12 transplant centers have been onboarded and eight additional transplant centers are in the onboarding process.
Patients are enrolled in the company’s Gamida Cell Assist program, which means that their transplanter has the intent to utilize Omisirge as the patient’s donor source.
The company has confirmed coverage with payers who cover more than 85% of commercial lives and is in ongoing discussions with additional commercial payers.
CMS coverage and reimbursement has been confirmed for patients covered by Medicare. All required documentation is in place for patients who are covered under Medicaid, Department of Defense and Veterans Affairs.
The company is ready to reliably deliver Omisirge within 30 days from the start of manufacturing.
Publication: The company announced the publication of a prospective sub-study of the Phase 3 clinical trial for Omisirge titled "Immune Reconstitution Profiling Suggests Antiviral Protection After Transplantation with Omidubicel: A Phase 3 Substudy." The publication is available online on the Transplantation and Cellular Therapy journal website.
Strategic review: The company continues to work with Moelis & Company LLC to engage and advance discussions with multiple parties as part of its efforts to explore alternatives to support a fully resourced launch.( Meaning no BP willing to jump into a JV YET)
Terry Coelho, MBA, appointed Chief Financial Officer: In May 2023, Gamida Cell announced the appointment of Terry Coelho as Chief Financial Officer. Ms. Coelho, a seasoned finance executive with more than 35 years of experience across all areas of finance and business development at emerging growth companies and established global companies, is positioned to support Gamida Cell’s transition into a commercial-phase company and its pursuit of a strategic partnership.
Jeremy Blank appointed to Board of Directors: In August 2023, the company’s Board of Directors appointed Jeremy Blank, Chief Investment Officer of Community Fund, to the Board, where he will serve on the Transactions Committee. "Having closely followed Gamida Cell for over a decade, it is a privilege to join the Board of Directors," said Mr. Blank. "I have high confidence in Gamida’s team and technology and our firm invested in both of Gamida’s most recent equity offerings. I look forward to supporting Gamida’s strategic process which is a great opportunity to create shareholder value." Mr. Blank will provide a valuable perspective to the Board as it aids the company in executing its corporate strategy. From 2005 to 2020, Mr. Blank also served as a partner at York Capital Management, a $15 billion global investment fund. Before that, he was a Vice President and credit analyst at Morgan Stanley. Mr. Blank currently serves as a Director on the boards of Insightec Ltd. and Advanced Emissions Solutions, Inc. (NASDAQ: ADES). Community Fund is a significant shareholder in Gamida Cell.
Strengthened balance sheet: The company ended the second quarter with $54.1 million in cash as a result of the net proceeds of $29.8 million from both the April equity offering and the at-the-market offering (ATM), thereby extending cash runway into the second quarter of 2024. Additionally, the company reduced its outstanding principal balance in the quarter by $9.0 million, from $94.0 million to $85.0 million.
Investor Day: Gamida Cell hosted an Investor Day on June 29, 2023. The event was attended by over 180 participants, both in-person and virtual, and included an update on the commercial launch of Omisirge as well as discussions with industry thought leaders. Steven Devine, M.D., Chief Medical Officer at the National Marrow Donor Program® (NMDP)/Be The Match®, discussed the unmet needs and barriers to care in stem cell transplant, and explained how Omisirge can help address some of these issues. Usama Gergis, M.D., MBA, Professor of Oncology & Director of Transplant and Cellular Therapy, Sidney Kimmel Cancer Center, Thomas Jefferson University, discussed the implications of a health outcomes economics research model developed in partnership with Gamida Cell that showed that a 20% peak market share of Omisirge may increase transplant access for eligible patients, particularly those from racially and ethnically diverse groups that are currently underserved.
Phase 1 study: Gamida Cell’s GDA-201, an intrinsic natural killer (NK) cell therapy candidate being investigated for the treatment of hematologic malignancies, is being evaluated in an ongoing Phase 1 study for treatment of non-Hodgkin lymphoma. The study is continuing to enroll patients at six sites in the U.S. Data are expected in the first quarter of 2024.
Data presented at International Society for Cell and Gene Therapy (ISCT) 2023 Annual Meeting: GDA-201 data presented at ISCT on June 2, 2023 demonstrated the robustness of cryopreserved GDA-201 and continued to support signs of strong lymphoid homing and decreased exhaustion of GDA-201 cells.
New data on nicotinamide (NAM) mechanism of action: Data published in Science Translational Medicine in the July 19 edition demonstrated that culturing NK cells with NAM, which the company uses to enhance and expand cells, and IL-15 increases metabolic fitness, energy charge and glucose flux within NK cells, providing a pathway for resistance to oxidative stress and increased potency compared to NK cells cultured with IL-15 but without NAM. Through preventing degradation of the protein FOXO1, the presence of NAM was found to increase levels of CD62L, an important lymph node homing marker. This expression cascade provides evidence for the strong lymph node homing, direct killing and antibody dependent cell-mediated cytotoxicity capabilities of NK cells cultured with NAM. The publication also includes outcome data from the Phase 1 dose escalation clinical trial for Gamida Cell’s NK cell therapy candidate GDA-201 in patients with non-Hodgkin lymphoma as well as translational data from biopsy specimens.
Second Quarter 2023 Financial Results
Research and development expenses were $8.7 million in the second quarter of 2023, compared to $10.6 million in the same quarter in 2022. The decrease of $1.9 million was primarily due to a $1.6 million reduction associated with the discontinuation of development of our engineered NK cell therapy pipeline, and $0.7 million in lower Omisirge Phase 3 spend, including a decrease in payments for manufacturing services, partially offset by a decrease of $0.4 million in IIA (Israeli Innovation Authority) income.
Commercial expenses were $3.9 million in the second quarter of 2023, compared to $3.2 million in the second quarter of 2022. The increase of $0.7 million was attributable to an increase in launch readiness activities.
General and administrative expenses were $6.3 million in the second quarter of 2023, compared to $4.3 million in the same period in 2022. The increase of $2.0 million was associated with higher professional services expenses, in part due to the April 2023 follow on offering and business development activities.
Financial expenses, net, were $12.9 million in the second quarter of 2023, compared to $0.5 million in the same period of 2022. The increase of $12.4 million was primarily due to non-cash expenses totaling approximately $10.4 million, including the fair value impact on our warrants liability of $4.9 million, the fair value impact on the 2022 convertible note of $4.3 million, and a decrease in capitalization of finance costs to fixed assets of $0.6 million. In addition, the increase was due to higher cash expenses of $2.0 million, including $1.7 million in issuance costs from our April 2023 underwritten public offering and an increase of $1.0 million in interest expenses associated with the 2022 convertible notes, partially offset by increased interest income of $0.5 million.
Net loss was $31.7 million in the second quarter of 2023, compared to a net loss of $18.6 million in the second quarter of 2022, driven primarily by the increase in financial expenses of $12.4 million.
Cash Position: As of June 30, 2023, Gamida Cell had total cash and cash equivalents of $54.1 million compared to $64.7 million as of December 31, 2022. The decrease of $10.4 million is due primarily to net cash used in operating activities of $44.3 million partially offset by $34.7 million in net cash proceeds from the issuance of shares and warrants from our underwritten public offering and the issuance of shares via the ATM facility. Subsequent to the quarter close and through August 9th, the company raised an additional $14.0 million in net proceeds via the ATM facility. The company expects its current cash and cash equivalents, including the funds raised subsequent to the close of the second quarter, to support its ongoing operating activities into the second quarter of 2024, based on Gamida Cell’s current operational plans and excluding commercialization activities beyond the initial launch of Omisirge, as well as any additional financing activities that may be undertaken.
Debt Position: As of June 30, 2023, the company had reduced its principal balance on the 2022 secured convertible note by $15.0 million, from $25.0 million as of December 31, 2022, to $10.0 million at the end of the second quarter. The company also holds a 2021 convertible senior note with an aggregate principal amount of $75.0 million.
Conference Call Information
Gamida Cell will host a conference call today, August 14, at 8:30 a.m. ET to discuss these financial results and company updates. To access the conference call by phone, please register here and be advised to do so at least 10 minutes prior to joining the call. A live conference call webcast can be accessed here and also in the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com. A webcast replay will be available approximately two hours after the event for approximately 30 days.
Gamida Cell Ltd: Promising Stock Performance and Potential for Significant Growth in the Next 12 Months
Gamida Cell Ltd, a biotechnology company specializing in cell therapies, has been attracting attention from investors due to its promising stock performance. On August 11, 2023, the stock price of GMDA stood at 1.21. However, analysts have projected a significant increase in the stock price in the next 12 months.
According to data from CNN Money, four analysts have provided their 12-month price forecasts for Gamida Cell Ltd. The median target price is 6.00, with a high estimate of 11.00 and a low estimate of 5.00. This indicates a potential increase of 397.93% from the current price. Such optimistic forecasts suggest that investors are confident in the company’s future prospects.
Furthermore, a consensus among the four polled investment analysts suggests a unanimous “buy” rating for Gamida Cell Ltd. This rating has remained unchanged since June, indicating a consistent positive sentiment towards the stock. Investors are likely attracted to the company’s innovative cell therapies and potential for growth in the biotechnology sector.
Gamida Cell Ltd reported earnings per share of -$0.20 for the current quarter. Investors should focus on the company’s long-term potential rather than short-term earnings.
Gamida Cell Ltd reported sales of $165.0K for the current quarter. Investors should consider the company’s pipeline of potential therapies and partnerships to gauge its future revenue generation capabilities.
Looking ahead, investors should pay attention to Gamida Cell Ltd’s upcoming reporting date on August 14. Positive news or updates regarding clinical trials, partnerships, or regulatory approvals could potentially drive the stock price higher.
In conclusion, Gamida Cell Ltd’s stock performance on August 11, 2023, showed potential for significant growth in the next 12 months. The consensus among investment analysts is to buy the stock. Investors should focus on the company’s long-term potential and upcoming reporting date for further insights.
Gamida Cell's Earnings: A Preview
by Benzinga Insights, Benzinga Staff Writer
August 11, 2023 11:01 AM | 1 min read
Gamida Cell is set to give its latest quarterly earnings report on Monday, 2023-08-14.
Here's what investors need to know before the announcement.
Analysts estimate that Gamida Cell will report an earnings per share (EPS) of $-0.18.
Gamida Cell bulls will hope to hear the company announce they've not only beaten that estimate, but also to provide positive guidance, or forecasted growth, for the next quarter.
New investors should note that it is sometimes not an earnings beat or miss that most affects the price of a stock, but the guidance (or forecast).
Note: IMHO The price is not acting as if there is any partnership anywhere in the near horizon.
The CC will not add anything of substance but wishful thinking hintss of ongoing negotiations
with various interested parties.
Hoping for the best - prepared for the worst.
I offered my opinion several time the past weeks,
namely, with no partnership announcement, the
share price will deteriorate.
With no partnership alongside upfront monies, an
offering is inevitable, a matter of sooner than later.
Message for midastouch017 WHAT IS GOING ON IN YOUR MIND WITH GMDA ? Hope we do not break under $1 before Aug 14 call. It is really testing my patients but I am still going to hold tight till after the call if they do not come accross with something very POSITIVE. Atleast tell us they are in positive talks with a number of possible partners or possible takeover canidates, This would not violate SEC rules. Right now they telling us nothing is a slap in the face to we their investors as the share price continues to tumble. Even GOD will not be able to help us if they announce a share offering at this point.
OOPS, Thank you for correcting me! Sorry!
Are you referring to Monday, Aug 14th, 8:30 AM discussing earnings? TIA
Finished replacing the 5000 shares I gifted. Looking very forward to the confrence call on the 14th. I hope they beat the expected -.194 the market expects. There has to be some positive news somewhere to get the share price moving again in the right direction. If they announce that they are going it alone on marketing their golden egg I expect the share price to dive in the wrong direction as it would probably create them selling more shares to get funding. As I said it on an earlier post I do not think that would be a bad idea until they get the product into the market place and some positve results get published.
YES, thank you brother for your insights and God bless you!!!
Most Welcome Rich,
BTW i have edited my previous
post, you might be interested to
Thank you gents for sharing and your insights! Best…
“Yeah, just looked into it a bit more and it looks to me like they’re raising enough to start launching and buy time to find a partner or a suitor.
If neither of those happen in the next qtr they’ll probably be back to the well again for a bigger chunk of shares.”
Almost four months since FDA approval. You guys are correct, given the big picture, we are looking down the barrel of another raise SOON for a significant amount of shares given the lack of a partnership. Life in the fast last for biotech!!
GMDA vs. BLRX
I’ve seen some comparisons between Gamida and Bioline RX on other message boards that imply that BLRX is superior and will become the standard of care in stem cell mobilization.
That being said, Gamida obviously has an approved product and is working on getting it launched. It would seem they have a 6-12 month lead on BLRX even if it gets approved as well.
I have not done much digging trying to compare and contrast but am wondering if the prospect of BLRX’s approval in the same space could hinder buyout or partnership efforts for Gamida?
Gamida Cell to Report Second Quarter 2023 Financial Results
Conference Call and Webcast Scheduled for Monday, August 14th at 8:30 am Eastern Time
BOSTON, August 01, 2023--(BUSINESS WIRE)--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 second quarter ended June 30, 2023 on Monday, August 14, 2023.
Following the release, management will host a conference call and live webcast at 8:30 am Eastern Time to discuss the financial results, provide corporate updates and answer questions.
To access the conference call by phone, please register here and be advised to do so at least 10 minutes prior to joining. A live webcast of the conference call can be accessed by computer in the "Investors & Media" section of the Gamida Cell website at www.gamida-cell.com. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.
Well done. IMHO EVGN is a wise
longterm investment choice!
Bought more GMDA today. Have to buy couple more thousand to get my share count back up to replace what I gifted. Someone tell them to hold any positive announcements till Wednesday at the close.(HEE HEE)!!!!!! Also bought small amount of EVGN
“One other company i am invested in, PLX with a similar pattern, namely a surge after a (much awaited) FDA approval, to be followed by a constant share decline.
A very strange phenomenon!”
Yes sir, another example highlighting a significant pullback on FDA approval. Possibly these type of biotech companies are being shorted on “good news” knowing that their will be a period (several quarters) of time before these companies are cash flow positive. Plenty of time to cover the short position. That’s my only guess at this point.
Anyone else have a theory?
Happy Weekend all!!
GOD BLESS YOU BROTHER!!!
A month ago, I got a monster, MONSTER inheritance and I don’t intend to waste a dime of it on this shit market so I closed my account. I hope GMDA goes bananas. I’ll be cheering for you guys the whole way.
WOW, bro, not a good move at all, buyout is anytime!!!!!!!!!!!
I think some outfit wants to buy this company real cheap and if so I hope management stuffs it in their ear and goes it alone for a while till GMDA shows some earnings and then watch the share price move back into the upward position.
It looks to me as there was 400,000+ more buy shares traded today than sell shares traded. In that case unless there were some very large sell trades we should not have had a losing day. Am I wrong. There were around 803,000 buys to 389,000 sells shown on investors Hub site. Again what am I missing were there some huge sell trades I can't see??
Agree and same back at you
One element outside of announcing a partnership or a buyout, I’m very much interested in hearing from GMDA executives about the first patient treated successfully with details on how the patient faired apropos the treatment itself and anything else of material considerations. This type of communication I believe would significantly elevate the PPS and give credibility/credence to GMDA’s FDA approved treatment. JMHO
I am not complaining. If they want to hold it in this range that is fine with me as long as they don't hold this level when positive news hit the wires. Next expectation if nothing else will be an earnings report mid August. This should show less of a loss and considered positive news unless the market people play it as they expected an even bigger improvement in the loss. WE SHALL SEE!!!! LET us BE positive
IMO, BO is on the horizon? Novartis is hungry!
With no news, this will be the price range.
News of substance will make the sp rise
If you have been tracking the trading price per share for the last 10 trading days you will see that the trading has been manipulated to trade tight between $1.49 up to $1.52-53 cents. This has to be done for a reason don't you think.
that was a very nice thing to do...so much better than material things or plain old cash...shows her how much Dad continues to care...and much love...