Q4 2020 Bellicum Pharmaceuticals Inc Earnings Call
Greetings and welcome to the belly come Pharmaceuticals fourth quarter, 2020 financial results and corporate update conference call.
At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad. Please.
Please note. This conference is being recorded I will now turn the conference over to our host Robert all of Westway ICR. Thank you you may begin.
Thank you good afternoon, everyone and thank you for joining the call with me today on the call is Rick Fair, <unk>, President and Chief Executive Officer.
Earlier this afternoon <unk> released financial results for the fourth quarter and full year ended December 31 and 2020.
If you have not received this release or if you would like to be added to the distribution list you can do so on the Investor Relations page of the company's website.
As a reminder, today's conference call will include forward looking statements made under the private Securities Litigation Reform Act of 1995, including statements regarding our research and development plans clinical trials plans regarding regulatory filings review and approval of our product candidates.
Realization expectations and our financial outlook. These forward looking statements involve a number of risks and uncertainties and reflect our opinions only as of the date on this call.
We undertake no obligation to revise or publicly release the results of any revision to these forward looking statements in light of new information or future events. Actual results may differ from those indicated by these forward looking statements due to numerous factors, including those discussed in the risk factors section of our form 10-K.
For the year ended December 31, and 2020 and 10-Q for the quarter ended September 32020 filed with the S. E C.
And available on their website.
Now I will turn the call over to Rick Fair, <unk>, President and CEO.
Thanks, Robert Good afternoon, everyone and thanks for joining us.
On our call today I'll provide an overview of our recent progress and update on our go car platform and programs and a financial summary of the fourth quarter and full year 2020.
Our clinical progress and the fourth quarter was highlighted by the enrollment and a for instance, and our first patients and our phase one two trial evaluating <unk> six and three in patients with her two positive solid tumors, including breast endometrial and ovarian and gastric and colorectal cancers.
<unk> six and three is our first dual switch go car T product candidate to enter clinical development.
In addition to our clinical progress and the fourth quarter, we refined our focus on our next generation car T cell therapies, which allowed us to take steps to reduce our cost structure.
In October we implemented a restructuring plan that included a reduction of our headcount pause of RBC and May go car NK preclinical program.
Continuation of discovery research and sale of our research facility.
We also strengthened our balance sheet by raising capital via an underwritten offering of common stock and warrants and repaying our outstanding debt.
Some of these changes were difficult we expect they will result in significant cost savings going forward and enabling us to focus our research sources on a go cart clinical programs.
Before I go into the specifics of our programs. Let me provide a brief reminder of our go car platform, which is differentiated and two ways.
First we've engineered go car and an effort to deliver more potent and durable efficacy.
We intend to accomplish this primarily through our co activation domain Mighty 88 C D 40 or M C.
We believe M C signaling can boost effector cell proliferation and survival and.
And functional persistence by resisting exhaustion and the suppressive tumor microenvironment and stimulate the cancer patients' own immune system to eliminate cancer.
Second we've engineered go car for higher performance offering the potential for superior control via our molecular switch technology.
Other car therapies behave unpredictably due to their autonomous activity. The go kart anti tumor effects can be controlled by the scheduled administration of or maybe you said.
No car activity can be dialed up or down by adjusting the interval between gonna be just and doses, we're suspending room and you said administration.
Our dual switch product candidates are designed for further improved controllability by incorporating our cash besides safety switch, which can rapidly eliminate ourselves when triggered to manage acute toxicities if they occur.
We believe our next generation go car platform can address many of the shortcomings of current cell therapies are preclinical investigations and demonstrated some of these potential benefits and we've observed supported biomarker evidence of these effects from the clinic.
We believe the go car platform may be particularly well suited for use in solid tumors or the effects of M. C. Signaling may help overcome the challenges of the hospital tumor microenvironment T cell exhaustion and heterogeneous antigen expression that have confounded previous car T efforts.
This is the rationale for our two solid two tumor go car keep candidates <unk> 601 and bps 603.
Let me now provide and update for each of these programs.
Our first and most advanced <unk> car T product candidate <unk> 601 targets prostate stem cell antigen or P. S. C. A T.
Clinical data, we've presented to date from dose escalation and and ongoing phase one and two trial in pancreatic cancer have shown encouraging safety biologic activity and biomarker data that support the hypothesized benefit since they go car platform.
We're particularly encouraged by the findings of tumor infiltration go car T mediated immuno modulation.
Persistence of cells for up to nine months and changes and gene expression and the tumor microenvironment consistent with a productive car T cell immune response.
We've opened enrollment and the trials of patients with previously treated metastatic castration resistant prostate cancer and plan to focus on these patients moving forward and in an effort to translate these encouraging biomarker findings and the clinical benefit.
And January we announced that the FDA had lifted the clinical hold on patient enrollment and dosing for <unk> 601, resulting from the death of the pancreatic cancer patient and the study.
Through December and January our team worked diligently with the agency to answer their questions and resolve the clinical hold issues.
We have resumed patient enrollment without any required modification to the clinical protocol.
We remain excited about the potential for <unk> six on one and prostate cancer, both as a product candidate and is proof of concept for Argo car platform. We plan to present phase one data update on bps six I'm one of them made you say and these patients in the first quarter of 2022.
Now, let me update you on <unk> six and three.
This program is <unk> first dual switch product candidate, which has been designed to target solid tumors that express or two.
As I mentioned, we enrolled our first patient in this trial in December and enrollment at the first dose level is ongoing.
We chose her two as a target for <unk> six and three because it's a thoroughly validated target entrance and for cancer therapy, and because academic her two car T trials have demonstrated clinical activity and reasonable safety.
We believe that our dual switch technology and <unk> six and three may be uniquely suited to improve upon these earlier efforts by driving greater efficacy through M C signaling and providing an extra layer of safety via our switch platform.
The trial is a true traditional three plus three dose escalation and followed by phase II expansions and multiple her two positive cancers.
Dose escalation has begun at Tenda and the fifth cells per kilogram and patients will be sequentially enrolled through dose escalation.
Patients received standard XI Fu conditioning, followed by a <unk> 603.
The first patient and each dose cohort will be followed without subsequent treatment, while the remaining patients and each cohort will receive weekly room, and you said to either dose limiting toxicity or disease progression.
We expect to provide initial phase one data from this trial and the second half of 2021.
We're excited to have this trial underway and we'll keep you posted on our progress.
One final thing I'd like to mention is publication of a compelling case report and the use of our cash besides safety switch.
By way of context, we have excellent clinical validation of cast aside and.
<unk> 2018, we presented data on 24 patients who received or maybe you said to trigger cast beside to mitigate steroid refractory gvhd caused by genetically modified allogeneic T cells.
And these patients best overall Gvhd response rate was 70% with a median time to response of one day.
Despite these great data one remaining question about the technology has been well it we're quickly enough to address serious adverse events like cytokine release syndrome, and neurotoxicity observed in patients receiving car T therapy.
In February we announced the first reported use of the cats, Besides safety switch and this exact clinical situation.
The report published in the digital edition of blood.
It was the case from an investigator sponsored trial at the University of North Carolina about <unk> car T cells, expressing CD 19, and our safety switch.
This patient received or maybe you said to trigger cast beside to treat grade for immune effector cell associated neurotoxicity syndrome, or I cans, which was refractory to standard treatments.
According to the investigator the safety switch reduced the number of circulating modified T cells by nearly 60% within four hours and by more than 90% within 24 hours.
Within 12 hours of it made you sit administration I cans and improved two grade one and was fully resolved after four days.
While only a single case report this is highly encouraging since cast beside is incorporated into a number of car T and car NK collaborations and our own VPN six and three we look forward to potentially adding to this day to set over time.
That concludes the recap of our programs. Let me now provide a brief review of our financial results.
R&D expenses were $8 7 million and $39 $1 million for the fourth quarter and year ended December 31, 2020 and respectively.
Compared to $13 3 million and $64 5 million during the comparable periods in 2019.
The reduction and expenses in the fourth quarter of 2020 just from my.
Primarily due to reduced riva sell activities and manufacturing facility sale and the corporate restructuring implemented during the fourth quarter of 2020, offset by an increase and expenses related to the go car programs.
General and administrative expenses were $3 4 million and $15 $5 million for the fourth quarter and full year 2020, compared to $5 7 million and $30 million for the comparable periods in 2019.
The lower expenses and the fourth quarter of 2000, and 'twenty relative to prior year were primarily due to the reduction and reversal related commercialization activities and the effects of the corporate restructuring that reduced employee related expenses.
Pelican reported a loss from operations of $13 million and $51 $7 million for the fourth quarter and full year 2020.
Impaired to a loss from operations of $13 9 million and $87 $4 million from the comparable periods in 2019.
Pelican and reported net income of $18 $8 million and a net loss of $7 $7 million for the fourth quarter and full year 2020, compared to a net loss of $29 million and $112 $5 million for the comparable periods in 2019.
These results include a noncash gain of $31 9 million and $46 $1 million for the fourth quarter and full year 2020 related to the change in fair value of the warrant and private placement option liability.
Turning to the balance sheet as of December 31st 2020, cash cash equivalents and restricted cash totaled $37 million compared to $93.8 million as of December 31, 2019.
And November 'twenty, and 'twenty delicate and completed an underwritten offering of approximately 1 million shares of common stock pre funded warrants to purchase approximately $3 1 million shares of common stock and accompanying warrants to purchase approximately $4 $1 million million shares of common stock.
Gross proceeds to Pelican, where approximately $25 million before deducting underwriting discounts commissions and other offering expenses payable by the outcome and excluding any proceeds that maybe received upon exercise of the warrants.
And October Belloc from repeat and fall all outstanding indebtedness and terminated all commitments and obligations under its loan agreement with Oxford finance for a payment of $27 $4 million.
Based on current operating plans, we expect that current cash resources will be sufficient to meet operating requirements into the second quarter of 2022.
Reviewing our accomplishments in 2020 and looking ahead into 2020, one and I'm pleased by the advancement of our <unk> pipeline, including the resumption of our clinical trial for <unk> 601, and patients with prostate cancer, and I and D clearance and initiation of our clinical trial for <unk> 603, and her two positive solid tumors.
We're planning to present initial clinical data from <unk> six or three later this year and additional clinical results from <unk> 601, and the first quarter of 2022.
I remain excited about our future the potential of the go kart pipeline and look forward to updating you on our future progress.
I will now open the call to questions operator.
Thank you ladies and gentlemen at this time, we will be conducting a question and answer session.
If you would like to ask a question. Please press star one on your telephone keypad.
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You May press star and the Starkey followed by the number two if you would like to remove your question from the queue from participants using speaker equipment and may be necessary to pick up your handset before pressing the star keys, one moment, please while we poll for questions.
Our first question comes from why don't you see Li with Ladenburg and please state your question.
Alright, Thanks for taking my question and just a very quick one so could you provide any further color on what kind of data should we expect a when you reported a three to 460, sorry, and the second how could you share and Oh, one and the first quarter next year. Thank you.
Sure. Thanks for the question on Big D VX 603.
And would expect our the first dose level presented and perhaps a patient or two from the second dose level I'll remind you that the design of that trial requires sequential enrollment enrollment through dose escalation and so it does take a bit of time for us to a crew that study so I'd expect safety data from that.
And safety data from the first dose cohort and potentially some patients from the second cohort is.
As it relates to the PBX 601, a readout and obviously, we're at a higher dose level. There already we're treating patients with 5 million cells per kilogram, which is a reasonable cell dose. So certainly and dose escalation. We still are evaluating safety, but wed also expect a pull from analysis of efficacy and biomarker and clinics.
To demonstrate what we're seeing are looking for a signal and metastatic ER CRP C.
I'd expect two to three cohorts of patients there, but of course that'll be dependent upon enrollment.
Got it thank.
Thank you very much.
Thanks Wendy.
Yeah.
And thank you just from either through the audience to queue up for a question you can press star one on your phone and thank you.
And Hey, this is Robert Who'll I've had a couple of questions come in to me over email from people on the webcast. So let me just far away with the with those.
Sure Rick.
Can you provide any additional color on the patient that died that resulted in the clinical hold and what helped the F. D. A become comfortable so that they would let you restart the trial without any kind of change to the protocol.
Sure.
Patients, who are who passed and the study was an elderly second line pancreatic cancer patients who received.
<unk> 601, followed by a two weekly doses of Bermuda you said.
The patient developed a great for cytokine release syndrome, and was undergoing treatment with standard treatments. However.
However in parallel with the patient was diagnosed with aspiration pneumonia and sepsis syndrome, which was deemed unrelated to our treatments of course.
While these complications were on going his family withdrew medical care and requested comfort care only and and the patient died and subsequently that later that day.
Cause of death are determined by both the investigator and telecom was aspiration pneumonia sepsis syndrome and that was supported by a review of the safety Review Committee.
That said based on the temporal relationship of deaths just a couple of days after the second dose and remediate said the FDA puts a trial on hold and ask for some additional data about the patient case and about the safety that had been observed and the trial to date once they reviewed the information we provided they remove the clinical hold without any required.
Vacations to the clinical protocol, so well they don't clarify how they interpreted the data that we submitted I think it's reasonable to assume that their analysis was the same as ours that this was an unfortunate case of a very sick elderly pancreatic cancer patient who are who died of complications.
Okay. Thank you and then one other one question that's come in and is about the case report of the use of the cash. Besides technology you mentioned, it's in a number of collaborations. So can you just tell us about those and what kind of economics. It represents for you and does a report like this help bolster your B D.
Or to you know get that out there and into more people's hands and into their programs.
Sure. Thanks for the question Robert we remain very excited about the safety switch. We think it is a useful addition to really any and cell therapy and the.
The performance observed as I as I reported in and both the previous.
Experience as reported at Ash a couple of years back in this case report suggests it's really a best in class solution for acute toxicities of cell therapies.
We are open to partnering this technology I would say to date most of the collaborations that we have our academic collaborations with investigators who are pursuing and.
New cell therapy, construct or and or new targets that may have a particular safety liability and what the additional comfort of having the safety switch embedded.
But of course, some of those and then translate into a more meaningful collaborations for US for example, we previously announced.
Our agreement with MD Anderson for the aircraft's beside kids and containing CD 19 car NK candidate.
Which we share and the economics they receive for the project from their licensee at Takeda.
That project continues to advance and we remain open to pursuing deals of this nature opportunistically when they make financial sense and when they don't compete with our pipeline.
Okay terrific. Thank you.
And thank you and there appears to be no more questions from our audience I will now turn the call back to Mr. Fair for closing remarks. Thank you.
Thanks, everyone for participating today, if you have additional questions feel free to contact us anytime and closing I'd like to thank our great team of evolutions, our collaborators and our investigators for their efforts and these extraordinary times and as always and most importantly, and I'd like to thank the patients and the families who participate on our clinical trials. They inspire our effort each and every day. Thanks.
And have a great evening.
Thank you. This concludes today's call all parties may disconnect have a great evening.