Panbela Therapeutics Inc. Q1 2023 Earnings Call
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At this time, all participants have been placed on a listen only mode and the floor will be opened for questions and comments after the presentation.
It is now my pleasure to turn the floor over to your host Mr. James Carbonara, Sir the floor is yours.
Thank you operator.
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.
<unk> 10-K, and supplemented by subsequently filed quarterly.
Quarterly reports 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 I would like to turn the call over to Jennifer Simpson CEO of 10 dollar 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.
We 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 programs I'd like to begin with our aspire global clinical trial in first line treatment of metastatic pancreatic cancer.
Aspire is a global randomized double blind placebo controlled clinical trial to evaluate I was spending or SPP 101 in combination with Gemcitabine and Nab paclitaxel in patients with untreated metastatic pancreatic ductal adenocarcinoma.
We continue Goldman enrollment and are focused on the country and site initiations for the aspire trial as we aim to have the full complement of sites onboard by the middle of this year.
And in all three regions Asia Pacific Europe , and North America enrolling with the recent release that South Korea enrolled its first patient is highly encouraging as we continue to advance the trial with the interim analysis expected in early 2024.
Additionally in January the European Medicines agency or EMA.
Committee for orphan medicinal products issued the adoption of commission implementing decision relating to the designation of idle spending as an orphan medicinal product in combination with Gemcitabine and Nab paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma.
Medicines that meet the EMEA.
Orphan designation criteria may qualify for financial and regulatory incentives, including a 10 year period of marketing exclusivity in the EU after product approval.
Assistance from the EMA at reduced fees during the product development phase.
Access to centralized marketing authorization.
Turning to familial adenomatous polyposis or F. A pea in April we learned that we will regain the north American rights to develop and commercialize them Tobey, which is the combination of a Florida and sulindac inpatients with FEP as a result of the pending termination of a licensing agreement between cancer Prevention Pharmaceuticals.
Or CPP and once you therapeutics assets limited.
Penn Bella is now positioned to take a lead on designing the global trial protocol and presenting it to the federal drug administration or F. D E and the MAA for agreement on the registration pathway.
By leveraging <unk> extensive experience with N P and in designing global registration trials. The team can develop a high quality trial protocol that meets the standards of regulatory agencies and is designed to efficiently and effectively demonstrate the potential safety and efficacy of some kobe and the treatment about.
P.
This approach will help achieve global regulatory approval and successful launch it's been Tobey and the global market.
We expect a new registration trial will focus on patients who haven't tapped lower gastrointestinal anatomy and will build upon the positive results from the FAA P. 310 trial that were published in the New England Journal of Medicine by Burke at all in 2020 and disease of the colon and rectal them with all of you.
Not at all in 2022.
That study showed 100% risk reduction in the need for surgery in patients with an intact lower gastrointestinal anatomy with Clint Tobey versus afford athene or still in DAC alone.
We believe that I think petri ton trial data is compelling and the new registration trial could lead to the approval of a simple way.
Since there are currently no approved drug therapies for the treatment at a P. This therapeutic option has the potential to impact this urgent unmet global need for patients with S. P.
We are confident that the new <unk> registration trial will have the potential to provide a nonsurgical treatment option to both physicians and their patients with a P.
Kimbell is committed to working collaboratively with the F. D. A E M E and the F. A P community to advance this program and to ultimately provide a new treatment option for a P. P patients.
We are excited to regain the worldwide rights Tucson, Toby for S E T patients.
We believe our internal expertise.
Curious with health authorities relationship with FEP experts throughout the U S and Europe , and our commitment to patients and their families in combination with the positive results from the prior F. N P 310 trial.
This gives us a solid foundation for designing and executing a successful registration trial that has the potential to impact patients with FEP globally.
We plan to advance this program, while maintaining our current cash burn and will evaluate opportunities to maximize the value of this asset.
Finally, we move to the phase three double blind placebo controlled trial of some tobey.
Rent recurrence of high risk Adenomas and second primary colorectal cancers in patients with stage zero to three colon and rectal cancer.
This trial known as the pace trial.
It's funded by the National Cancer Institute or NCI in collaboration with the Southwestern College group also known as Swab and we look forward to a futility analysis in the first half of 2023.
Moving to phase two study.
First there is an ongoing trial in relapsed refractory neuroblastoma, utilizing a quality and sashays there.
This trial is funded through the children's oncology group or Cogs and the MTI.
We also enrolled our first patient in our phase two double blind randomized study to evaluate CPP onex T or a Florida team tablet for recent onset type one diabetes.
We are excited to have the first patient enrolled in the phase two trial for CPP Onex T led by Indiana University School of Medicine, and funded by the juvenile diabetes Research Foundation, or J D or as the leading global organization advancing life changing breakthroughs for type one diabetes.
There are some 1.45 million Americans living with type one diabetes in the U S and there is approximately $16 billion in type one diabetes associated health care expenditures and lost income annually.
We are excited for the opportunity to test and validate our therapy in type one diabetes and the potential of this phase two trial to provide better treatment option for this patient population.
Additionally, we recently announced that abstracts about C. P. P. One act research also known as T. S M O or for the team had been accepted for poster presentation at the immunology of diabetes Society or <unk> meeting, which will be held may 23 through the 27th of 2023.
In phase one development, we have three programs that will be starting first of Floridians sashays will be evaluated in combination with keytruda and the stick 11 mutation population of non small cell lung cancer.
Our second phase one program, which is scheduled to begin this year will focus on the evaluation of I was I mean in the platinum resistant ovarian cancer population.
We recently presented a poster titled evaluating the efficacy of firming analogue I looked them in SPP 101 in combination with chemotherapy in ovarian cancer at the American Association for clinical research or a ACR meeting April 14th through the 19th of this year.
The poster highlight the efficacy of best between one one in combination with the standard of care chemotherapy agents used to treat platinum resistant ovarian cancer.
Excuse me with jumped siding towboat, he can and doxorubicin had been shown to significantly increase the in vitro toxicity of SPP 101 in both two this platinum sensitive as well as just platinum resistant ovarian cancer cell lines.
Paclitaxel and Docetaxel had been shown to not have any added benefit in vitro the SPP 101 alone.
Utilizing the beat it a positive murine ovarian cancer model the efficacy of S. P. P 101 in combination with either Gemcitabine Tobin chicken or doxorubicin was evaluated.
Jim So I didn't even interpret taken alone had little effect on the overall survival of mice.
Whereas either S. P P 101, or doxorubicin treatment alone.
Typically increased median mouth survival time.
The addition of SPP 101 improve the survival of mice treated with any of the three current.
Of the three chemotherapeutic.
The S. P. P. One one and doxorubicin combination might have the greatest survival time with a 265% increase in median survival compared to untreated animals.
Additionally, combining different though or authority with I've been in in vitro resulted in a cooperative anti proliferative response.
Even though has been shown to be well tolerated and can influence immune cell to promote a more immune friendly tumor microenvironment.
Future experiments will evaluate the effect of adding do you promote to either spend and treatment as well as the influence on immune cells within the tumor microenvironment.
The poster concludes that the treatment of mice containing beat it a positive ovarian cancer with S. P. P. One one in combination with doxorubicin significantly prolonged survival and decreased overall tumor burden.
Future studies will be designed to evaluate the effects of SPP 101 in combination with other mid calling me metabolism modulators as well as with immune modulators.
The results suggest that SPP wanted and comedy with Doctor visit and May have a role in the clinical management of ovarian cancer in particular, the platinum resistant population where few options exist.
These studies are the basis for moving into a clinical trial program in ovarian cancer with a goal of developing effective novel Therapeutics 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 in April we announced a new research agreement with the Johns Hopkins University School of Medicine.
Collaboration is intended to expand the development of Pandora's investigative agent I was filming in our Florida team, including activity in models of ovarian and other cancer types.
Further valuations into mechanism of action and potential combination of I've looked at it with a four nadine and standard of care agents.
Lastly, we are continuing to work with the key opinion leaders to finalize the new adjuvant pancreatic cancer investigator initiated protocol and obtain the necessary institutional approval to open this trial in the first half of this year.
To recap the milestones as we continue to execute our development programs, we anticipate the opening of the non small cell lung cancer stick 11 phase one trial.
Utility analysis from the swap colon cancer risk reduction trial the.
The opening of the new adjuvant trial, and the ovarian cancer trial.
Agreement of the FDA and EMA on our registration protocols for F E P.
Phase one non small cell lung cancer data in the second half of this year, which will inform the phase two portion of a non small cell lung cancer trial, which we hope to have open by year end.
Final data from the phase one programs in both first line metastatic pancreatic cancer as well as early onset type one diabetes.
And finally, the interim analysis of the aspire trial in early 2024.
In summary, we have made tremendous progress in Q1 and year to date, we are excited to build stockholder value as we move ahead in 2023 and onward by executing against our milestones I will stop here and turn it over to Sue to review the financials.
Thank you Jennifer.
General and administrative expenses were $1 4 million in the first quarter of 2023 compared to 1.8 million in the first quarter of 2022. The first quarter of 2022 spend was higher due to the C. P. P acquisition.
Research and development expenses were $3 5 billion in the first quarter of 2023 compared to $2 2 million in the first quarter of 2022.
The increase is due primarily to the expected ramp up of spending on the inspire clinical trial.
January 13th 2023, we affected a reverse stock split at a ratio of one for 40 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 one for 40 reverse stock split.
Net loss in the first quarter of 2023 was $5 1 million or 65 cents per diluted share compared to a net loss of $3 7 million or $10.91 per diluted share in the first quarter of 2022.
Total cash was approximately $5 2 million as of March 31st 2023.
Total current assets were $7 8 million and current liabilities were $9 7 million as of the end of the quarter.
On March 31st 2023, total non current assets, consisting primarily of cash deposits held by a contract research organization was $8 6 million.
During the quarter, we completed a public offering for gross proceeds of approximately $15 million.
Yeah.
As a result of the C. P. P acquisition, we added debt and accrued interest to our balance sheet.
During the quarter ended March 31, 2023, a portion of the debt and accrued interest was paid.
A scheduled payment of 1 million plus accrued interest at approximately 295000 with pay down the note with an original balance of $6 2 million the.
The principal balance now on this note is $5 2 million.
Also during the quarter the company made a payment of 650000 in principal and accrued interest of approximately 85000 on a second note. This note has now been paid in full.
Looking at the cap table as of March 31st 2023, we had approximately $16 1 million common shares outstanding and including shares reserved for options and warrants we were at approximately 22 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.
Our cash used in operations for the quarter ended March 31, 2023 totaled approximately nine 8 million cash used in operations for the quarter included approximately 2 million in prepayments necessary to secure the supply of standard of care chemotherapy therapy aging.
For the aspire trial.
As well as payments made to obtain current balances with key vendors.
As we have discussed we anticipate that the ongoing cash used in operations will be between five and five and a half a million per quarter and therefore are projecting that the current cash.
On hand will take us into very early Q3 of 2023.
We will continue to focus our cash on those items in our plan, which will drive value for our stockholders such as the aspire trial.
Operator can you. Please open the phone lines for Q&A and poll for questions.
Thank you.
At this time, we will be conducting a question and answer session.
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One moment, please where we pull for questions.
Thank you.
Our first question is coming from Jonathan myself with Ralph M M.
Thank you very much hi, guys. Good afternoon, and I was wondering for aspire or any new countries to be included on for that trial or will you.
Just open additional sites and currently enrolling countries or stick with the sites you have.
Yeah, Hi, good afternoon Jonathan.
For the aspire trial all countries have been approved we have two European countries that we are working to get the first site active all with the intent of having that full complement of sites onboard by roughly the middle of this year.
So we were making great progress.
Okay, great on on SAP can.
Can you tell us anything about securing partners for that.
Yeah I you know so as we looked at this one of the things that we thought would be put us in the best possible position is to secure the approval from both FDA and EMA on our global registration a protocol and I think that gives us a much more sure footing as we look.
To see how.
How we can best maximize that asset you know through collaborations partnerships et cetera. So that will be the first step is to seek that advice and as I mentioned in my comments you know, we we have a great deal of expertise as well as the relationships with the ethic P community both patients and Kols.
We feel pretty confident that we'll be able to get this protocol together and through the regulatory bodies hopefully very soon.
Okay that sounds like a good first step. Thank you. Thank you very much.
Oh absolutely.
Thank you once again, if there are any remaining questions or comments. Please press star one on your phone at this time.
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So this will conclude today's conference.
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