Q2 2023 Panbela Therapeutics Inc Earnings Call
[music].
Greetings and welcome to the <unk> Therapeutics second quarter 2023 earnings call. At this time, all participants are in a listen only mode.
<unk> 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 note. This conference is being recorded I will now turn the conference over to your host James Carbonara Investor Relations at Pembina, James You may begin.
Thank you operator with me on the call are Jennifer Simpson, Chief Executive Officer, and Sue Hornbeck, Chief Financial Officer.
Before I turn the call over to Dr. Simpson. Please note that statements made on this call that are not historical facts may be forward looking statements significant risks and uncertainties that could cause actual results to differ from those expressed or implied in the forward looking statements are detailed in the Companys annual report on Form 10-K, and supplemented by subsequently filed report quarterly.
Courts on Form 10-Q, as well as in other reports that the company has filed with the SEC any forward looking statements made on this call are made only as of today's date and the company does not undertake any obligation to update or supplement any such statements to reflect subsequent developments now.
Now I would like to turn the call over to Jennifer Simpson CEO penned Bella Jennifer. Please proceed.
Thank you James and thank you everyone for joining.
I will begin the call with a review of our clinical development program recent accomplishments and upcoming milestones.
<expletive> will then follow with a review of the financial results and then we will open it up for Q&A.
Starting with our phase III program I'd like to begin with our aspire global clinical trial in the first line treatment of metastatic pancreatic cancer.
Aspire is a global randomized double blind placebo controlled clinical trial to evaluate <unk> salmon or S. E. T 101 in combination with Gemcitabine and Nab paclitaxel in patients with untreated metastatic pancreatic ductal adenocarcinoma.
Last month, we opened enrollment in the U K and Germany.
We now have all planned countries and the aspire trial open and actively enrolling.
Also in July the independent data safety monitoring board or D. F N b for the aspire trial completed its pre specified review of safety data for <unk> treated patients in the trial.
The D. F&B has recommended that the study continue without modification.
Having all countries open and enrolling and D. S. M. D approval to proceed is highly encouraging as we continue to advance the trial.
Interim data is expected as soon as early 2024.
Yeah.
Turning to familial adenomatous polyposis or F. A pea in April we regained the north American rights to develop and commercialize clinically which is the combination of our Florida and showing that in patients with F. E P.
This opportunity surfaced as a result of the termination of a licensing agreement between our subsidiary cancer Prevention Pharmaceuticals, or C. P. P and once you therapeutics often limited.
Pam Bela has now taken the lead on designing the global trial protocol and presenting it to the federal drug administration, or FDA and the European Medicines agency or EMA for agreement on the registration pathway.
Pamela is committed to working collaboratively with the FDA EMA and the S. E T community to advance this program and to ultimately provide a new treatment option for patients.
Once agreement is achieved on a global registration program from the FDA and EMA, we plan to advance this program, while maintaining our current cash burn and will evaluate opportunities to maximize the value of this asset.
Moving to the pace trial, our phase three double blind placebo controlled trial of <unk> and Toby to prevent recurrence of high risk Adenomas and second primary colorectal cancers in patients with stage zero to three colorectal cancer.
The pace trial is funded by the NCI in collaboration with the southwest Oncology group also known as <unk>.
The trial is designed to evaluate the combination of quality into Iraq, and reducing a three year event rate of adenoma and second primary colorectal cancers in patients previously treated for stages zero to three colon or rectal cancer.
In June the trial passed a single planned futility analysis, and we will continue.
Moving to phase II study.
In July we announced we would receive a total of up to $9 5 million and non dilutive funding for a divestiture of assets within the authority in pediatric Neuroblastoma program to U S roadmap.
We look forward to helping U S well matched with the ongoing FDA review of a new drug application.
<unk> received an initial upfront payment of $400000.
And is entitled to future payments upon U S. Well successful completion of milestones related to a foreign Athena clinical development regulatory approval and commercial cell.
This agreement further expands our portfolio of partner funded programs and has the potential to generate considerable development milestone payments.
We welcome the U S well matched to our portfolio partners, who continue the development of our product candidates.
Continuing with phase two studies, we are excited to have had the first patient enrolled in the phase two trial for CPP Onex led by Indiana University School of Medicine, and funded by the juvenile diabetes Research Foundation for J D O F. The leading global organization advancing life changing breakthroughs for <unk>.
One diabetes.
This trial with a fast based on the preclinical and phase one data.
Two posters were presented highlighting the results for C. P. P. One act also known as D. F M O or Florida thing in recent onset type one diabetes at the Endocrine Society meeting in June of this year and the immunology of diabetes Society meeting in May of this year.
The work reflects the company's ongoing collaboration with Indiana University School of Medicine.
The research is part of a multi site clinical trial led by Indiana University School of Medicine, and supported by funding from J D O S.
These preclinical study examined the role of ornithine, Decarboxylate or O D. C on beta cells stress that occurs in type one diabetes.
Results show that stress human islet cells treated with CPP, onex and alterations and several pathway such as antibody antigen presentation and reactive oxygen species.
Together with data from recent onset type one diabetes patients treated with CPP onex and the multi site randomized placebo controlled phase one trial.
These results suggest that inhibition of OTC by CPP Onex may preserved beta cell function in response to stress.
Furthermore, these results expand on the previously presented work identifying potential mechanism for CPP onex and its potential role in the clinical management of recent onset type one diabetes.
We are excited to support the recently initiated IU and J D. O S funded phase two trial and recent onset type one diabetes and the goal of developing effective novel therapies for patients with unmet medical needs.
Results from these studies suggest that CPP onex is a safe oral treatment option that may improve beta cell function and survival in recent onset type one diabetes.
In phase one development, we have three programs that we will be starting.
First in May we entered into a clinical trial agreement with Moffitt cancer Center for Phase one two program and the stick 11 mutant non small cell lung cancer patients.
The initial goal of the phase one trial will be to ascertain the maximum tolerated dose before entity, while evaluating efficacy and then moving into a phase III efficacy trial.
We anticipate data from the phase one trial by the end of this year with a look to start the phase two trial at the end of the year or early 2024.
Our second phase one program, which is scheduled to begin this year will focus on the evaluation of other spending in the platinum resistant ovarian cancer population.
In April we presented a poster titled evaluating the efficacy affirming analog Ivo Salmon F. C. P 101.
In combination with chemotherapy in ovarian cancer at the American Association for clinical research or a ACR meeting.
The poster highlight the efficacy of SB 101 in combination with the standard of care chemotherapy agents used to treat platinum resistant ovarian cancer.
Future studies will be designed to evaluate the effects of SB 101 in combination with other colony metabolism modulators as well as with immune modulators.
The results suggest that S. P. P 101.
In common with Doctor Remington may.
It may have a role in the clinical management of ovarian cancer in particular.
Platinum resistant population, where few options exist.
These studies are the basis for moving into a clinical trial program in ovarian cancer with the goal of developing effective novel therapeutic in combination with standard of care for patients with unmet medical needs.
The work reflects the company's ongoing collaboration with Johns Hopkins University School of Medicine.
To that end also in April we announced a new research agreement with the Johns Hopkins University School of Medicine.
The collaboration is intended to expand the development of Penn valid investigative agent, either stem and Interflora Mcgee, including activity in models of ovarian and other cancer types.
Further evaluation into mechanism of action and potential combination of all those tenants with a foreign athene and standard of care agents.
Furthering the preclinical research we announced in June that we entered into a sponsored research agreement with the University of Texas, MD Anderson cancer Center for the valuation of Poly mean metabolic inhibitor therapy in combination with car T cell therapies in preclinical models.
The initial goal of these studies will be to ascertain if a florida thing and or Ivo Spellman treatment will augment car T mediated cytotoxicity against CD 19 positive large b cell lymphoma cell lines.
Recently, a metabolite panel, primarily consisting of poly means was identified as predictive of poor response to anti CD 19 car T cell therapy in relapsed refractory large b cell lymphoma.
Additionally, the polyamine uptake transport system is up regulated in large b cell lymphoma and multiple myeloma.
Together. This suggests the potential for poly mean targeted therapy in combination with car T therapies.
Paul any modulation of immune system is an important focus for pan Bella with our first clinical proof of concept of polyamine targeted therapy in combination with a checkpoint inhibitor for patients with stick 11 mutant non small cell lung cancer. We are excited for this research collaborations now evaluate the potential benefit of poly means.
In immune modulation for hematologic malignancies.
Well, we are continuing to work with the key opinion leaders to finalize the neo adjuvant pancreatic cancer investigator initiated protocol and obtain the necessary institutional approval to open this trial in the second half of this year.
To recap our planned milestones as we continue to execute our development program. We anticipate the opening up of Neo adjuvant trial, and the ovarian cancer trial by year end.
Phase one non small cell lung cancer data in the second half of this year, which will inform the phase two portion of the non small cell lung cancer trial, which we hope to have opened by year end or early 'twenty 'twenty four.
F. A pea on track to submit and receive feedback from FDA and EMA in the second half of this year to obtain global harmonization for registration protocol.
Data on our polymer metabolic inhibitors in combination with car T therapy, and preclinical lymphoma and multiple myeloma models.
And finally, the interim analysis of the aspire trial in early 2024.
In summary, we have made tremendous progress in Q2 and year to date.
We are excited to build stockholder value as we move forward.
For the remainder of this year.
I will now turn it over to Sue.
Yeah.
Okay.
Thank you Jennifer.
General and administrative expenses for 1.6 million in the second quarter of 2023 compared to 1.3 million in the second quarter of 2000 and tried to this increase is primarily related to increased professional services and annual meeting costs.
Research and development expenses were $4 2 million in the second quarter of 2023 compared to 20 million in the second quarter of 'twenty to 'twenty two.
The decrease was due primarily to a 17 7 million dollar write off of in process research and development or IP R&D in the second quarter of 2022 related to the C. P. P acquisition.
Excluding this one time write off of IP R&D R&D costs increased by 1.9 million due to the expected increase in spending on the aspire clinical trial.
On June 1st 'twenty to 'twenty, three we affected a reverse stock split at a ratio of one for 30 shares of the company's common stock.
All share and per share amounts of our common stock presented here and in our report 10-Q had been retroactively adjusted to reflect the reverse split.
Net loss in the second quarter of 2023 was 5.8 million or $7.95 per diluted share compared to a net loss of 22 1 million or $1843.68 per diluted share in the second quarter of 2022.
Total cash was approximately $7 2 million as of June 30th 2023.
Total current assets were $10 8 million and current liabilities were $10 6 million as of the end of the quarter.
On June 30th 2023, total non current assets, consisting primarily of cash deposits held by our contract research organization was $8 7 million.
During the quarter, we also completed a public offering for gross proceeds of approximately $8.5 million.
Yeah.
As a result of the C. P. P acquisition in Q2 of 'twenty to 'twenty two.
We added debt and accrued interest to our balance sheet.
During the quarter ended June 30th 'twenty, 'twenty, three no debt or interest payments were made.
The principal balance remaining on the node is 5.2 million and there is 100000 of accrued and unpaid interest on the balance sheet.
Looking to the cap table as of June 30th 2023 we had approximately $2 6 million common shares outstanding.
And including shares reserved for options and warrants we were at a total of approximately seven 5 million shares.
The shares reserved number includes all outstanding equity awards, including stock options, which were held primarily by insiders and all warrants to purchase common stock.
Due to the exercise of pre funded warrants and the alternative cashes exchange of warrants subsequent to June 30th.
And shares outstanding today total approximately 3 million shares.
Our cash used in operations for the six months ended June 30 of 'twenty trade three totaled approximately $15 5 million.
The quarterly burn rate for Q2 was approximately $5 7 million.
Cash used in operations for the six months ended June included approximately 3.1 million in prepayments necessary to secure the supply of standard of care chemotherapy agents for the aspire trial.
As well as payments made to increase the deposits held by our cero for future clinical trial costs.
We anticipate that the ongoing cash used in operations will be approximately $5 5 million per quarter. However, additional cash may be required to secure standard of care chemotherapy and fund new deposits held by our zero.
And therefore, we are projecting that the current cash on hand will take us through the end of Q3 2023.
We will continue to focus our cash on those items in our plans, which will drive value for our stockholders such as the aspire clinical trial.
Operator can you. Please open the phone lines now for Q&A and poll for questions.
Certainly at this time, we'll be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May Press Star two if you would like to remove your question from the queue.
For participants using speaker equipment that may be necessary to pick up your handset before pressing the star keys.
One moment, please while we poll for questions.
And your first question today is coming from Jonathan Aschoff from Roth at Mack M Cat.
Jonathan Your line is live.
Thank you good afternoon, Jennifer and Sue I was curious I don't know if you've covered this just been juggling three calls single handedly did you.
Where do you think you'll do with Slim Toby you know with respect to maybe handing it handing it to somebody else or not worth doing it internally maybe cover that I'm not sure.
Well certainly I think.
First of all Hello, Jonathan how are you and I.
We certainly understand juggling calls.
You know how it will be you know for us as we have maintained we will advance the program without changing our cash burn so probably the first and most important step since we have the expertise in house is to work with the F. D. A N E M E to have agreement on a go.
Global registration protocol and again, if you remember simple he had been a in a phase III registration program prior where it showed and an a priori analysis or a post hoc analysis, that's actually correct. It was a post hoc analysis.
It showed a.
Benefit to the patients and the lower G. I base. So we are taking this information back to the FDA and EMA to get the agreement on a global protocol and we feel at that point it will be in a really good place to secure them you know our partner or.
No path forward in.
In terms of funding that will impact our cash burn, but we're very excited to be moving this program forward and as I said, we do have the expertise in house. So I think this is this is something we're pretty excited about.
Okay and did you did you give something in your prepared remarks about the timing.
Two items. My next question is the timing for for public dissemination of both the stick 11 data in the J D. R. F funded trial.
I guess that was caught on your hands, Yeah, certainly certainly so does take 11 Ah trial, we started.
The Cta is signed and so we are working with moffitt in terms of enrollment for the phase one portion which will occur first we at this point, we are still anticipating data in the phase one portion by year end.
Which obviously would inform the phase two portion starting either year end or early 2024.
So that will be something we would certainly work with them in terms of a wage you highlight the data I'm, assuming we move into that phase two portion.
For JD are up.
Phase two trial.
The Indiana University, and J D or a funded a phase two trial has just started but I do think it's going to be some time before we have data from that that phase two trial.
Okay, and I believe I heard Sue correctly, you said cash through three quarter you go through this quarter or you know comfortably into the fourth.
True. This is the end of this quarter.
Okay. Thank you very much Jennifer and Susan Thank you.
Certainly thank you.
Thank you and once again its star one if you wish to ask your question. The next question is coming from Joe purchase from H C. Wainwright, Joe Your line is live.
Hi, This is Josh on for Joe. Thank you for the update well I was just wondering in terms of the aspire trial. So now that you have all the sites open what could we expect in terms of enrollment when that may be completed and potentially the number of patients that are expected.
Certainly a high Josh how are you Oh, yeah for good. Thank you. So we anticipate a total enrollment of approximately 600 patients.
And we are we believe that the enrollment will take in total roughly 36 months.
So we are the enrolment I will say it's been.
Quite robust so we've been very pleased.
This puts us on track for the interim analysis as early as the early portion of 2024.
And so I think that that's really the first and most important milestone really promoted from an efficacy standpoint.
And obviously, we were very pleased to pass the first D. F N b, a pre specified analysis as well.
Perfect. Thank you so much.
No. Thank you very much.
Thank you and there were no other questions in the Q&A queue at this time.
That does conclude today's call ladies and gentlemen, thank you for your participation you may disconnect your lines at this time.