Q4 2023 WidePoint Corp Earnings Call

Operator: Greetings, and welcome to Panbella Therapeutics' fourth quarter 2023 earnings call. Next 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, please call 1-866-333-8888.

Greetings welcome to Pandora Therapeutics fourth quarter 2023 earnings 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 note this conference.

Operator: Thank you. Thank you, conference; please press star zero. Please note this conference is, We will now turn the conference over to your host, James Carboni, and the NASA Relations Team. NASA Jet Propulsion Laboratory, California Institute of Technology, California Institute of Technology. Thank you, Operator.

Is being recorded I will now turn the conference over to your host James Carbonara.

James Carbonara: Investor Relations James you may begin.

James Carbonara: Thank you operator with me on the call are Jennifer Simpson, Chief Executive Officer, and Sue Horvath Chief Financial Officer.

James Carboni: With me on the call are Jennifer Simpson, Chief Executive Officer, and Sue Horvath, Chief Financial Officer. Before I turn the call over to Jennifer, 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 company's annual report on Form 10-K and supplemented by subsequently filed reports on Form 10-Q, as well as in other reports that the company has filed with the SEC.

James Carbonara: Before I turn the.

James Carbonara: Please note that statements made on this call that are not historical facts may be forward looking statements.

James Carbonara: Risks and uncertainties that could cause actual results to differ from those expressed or implied in the forward looking statements are detailed in the company's annual report on Form 10-K, and supplemented by subsequent reports on Form 10-Q as well as in other reports that the company has filed with the SEC.

James Carboni: 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 statement to reflect subsequent developments. Now I would like to turn the call over to Jennifer Simpson, CEO of Panvela. Jennifer, please proceed. Thank you, James, and thank you, everyone, for joining us.

James Carbonara: Any forward looking statements made on this call are made only as of today's date and the.

James Carbonara: The company does not undertake any obligation to update or supplement any such statements.

James Carbonara: Flex subsequent developments.

James Carbonara: Now I would like to turn the call over to Jennifer Simpson E O Pen Bella Jennifer. Please proceed.

Jennifer Simpson: Thank you James and thank you everyone for joining.

Jennifer Simpson: 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. So let's start with our phase three initiative, specifically the ASPIRE Global Clinical Trial. ASPIRE is a global, randomized, double-blind, placebo-controlled study designed to assess ibospemin, or SBP101, in conjunction with gemcitabine and nabpaclitaxel for patients with untreated metastatic pancreatic ductal adenocarcinoma. During Q4, the Independent Data Safety Monitoring Board, or DSMB, completed its second pre-specified review of safety data for treated patients, which included the first 214 patients in the trial. The DSMB has recommended that the study continue without modification.

Jennifer Simpson: We'll begin the call with a review of our clinical development program recent accomplishments and upcoming milestones.

Jennifer Simpson: It will then follow with a review of the financial results and then we will open it up for Q&A.

Jennifer Simpson: So let's start with our phase III initiatives, specifically, the aspire global clinical trial.

Jennifer Simpson: <unk> is a global randomized double blind placebo controlled study designed to assess ivo stemming or S. P. P 101.

Jennifer Simpson: In conjunction with Gemcitabine and Nab paclitaxel for patients with untreated metastatic pancreatic ductal adenocarcinoma.

Jennifer Simpson: During Q4, the independent data safety monitoring board or D. S. M D.

Jennifer Simpson: We did a second pre specified review of safety data for <unk> treated patients, which included the first 214 patients in the trial.

Jennifer Simpson: But the F&B has recommended that the study continue without modification.

Jennifer Simpson: Then, in January, we surpassed 50% enrollment for the ASPIRE trial, moving faster than originally projected. As we have reached the full complement of sites open and enrolling, we have seen a steady pace of enrollment, expecting full enrollment to be completed by the first quarter of 2025. We are looking forward to the interim data analysis based on overall survival. We originally projected this to occur in mid-2024. However, we have not seen enough deaths at this time.

Jennifer Simpson: Then in January we surpassed 50% enrollment for the inspire trial moving faster than originally projected.

Jennifer Simpson: And we have reached the full complement of sites open and enrolling we had seen a steady cadence of enrollment.

Jennifer Simpson: Speaking for enrollment to be completed by the first quarter of 2025.

Jennifer Simpson: We are looking forward to the interim data analysis based on overall survival.

Jennifer Simpson: We originally projected this to occur in mid 2024.

Jennifer Simpson: However, we have not seen enough deaths at this time with patients living longer we are evaluating the data and working to update the expected timing for the interim analysis.

Jennifer Simpson: With patients living longer, we are evaluating the data and working to update the expected timing for the interim analysis. There has also been positive movement in the metastatic pancreatic cancer treatment landscape. Based on the NAPLI-3 trial, Onabide was approved in February for use within the Neller-Fox regimen for first-line metastatic pancreatic cancer.

Jennifer Simpson: There also has been positive movement in the metastatic pancreatic cancer treatment landscape.

Jennifer Simpson: Based on the Napoli three trial antibody was approved in February for use within the Nellix much regimen for first line metastatic pancreatic cancer.

Jennifer Simpson: This approval was based on a 1.9-month median overall survival benefit, 11.1 months in the treatment arm versus 9.2 months for the control arm, which was jumped side to being an abraxane. This approval is significant to PAMBELLO for a number of reasons.

Jennifer Simpson: This approval was based on a 1.9 months median overall survival benefit.

Jennifer Simpson: 11, one months and the treatment arm versus 9.2 months for the control arm, which was jumped side to being an abraxas.

Jennifer Simpson: This approval is significant and Belo for a number of reasons. It is the first approval in first line metastatic pancreatic cancer in approximately 11 years.

Jennifer Simpson: It is the first approval in first-line metastatic pancreatic cancer in approximately 11 years. The 1.9 month survival benefit is similar to the approval of Gemcitabine and Abraxane versus Gemcitabine in the MPACT trial. Additionally, for the ASPIRE trial, it helps to validate the assumed median survival of the control arm, which has not changed greatly since its original approval 11 years ago with a median survival of 8.5 months in the MPAC trial. With enrollment in the ASPIRE trial moving faster than anticipated, we look forward to the overall survival interim analysis and the completion of the trial in the hope that our product may be a potential option for patients in the future. Turning to familial adenomatous polyposis, or FAP, PAMBELLA remains committed to collaborating with the FDA, EMA, and the FAP community to move this program forward, with the goal of bringing a novel treatment option for FAP patients. Once we obtain consensus on a global registration plan among the FDA and EMA, we plan to advance this initiative while upholding our established cost model. Concurrently, we intend to explore ways to maximize the value of this asset.

Jennifer Simpson: The 1.9 months survival benefit is similar to the approval of Gemcitabine and <unk> versus Gemcitabine in the impact trial.

Jennifer Simpson: Additionally for the aspire trial it helps to validate the assumed median survival of the control arm, which has not changed greatly since its original approval 11 years ago with a median survival of eight five months and the impact trial.

Jennifer Simpson: With enrollment of the aspire trial moving faster than anticipated, we look forward to the overall survival interim analysis and the completion of the trial in the hope that our product maybe a potential option for patients in the future.

Jennifer Simpson: Turning to familial adenomatous polyposis or F. A P $10 remains committed to collaborating with the F. D. A E M E and the F. A P community to move this program forward with the goal of bringing a novel treatment option for F. N P patient.

Jennifer Simpson: Once we obtain consensus on a global registration plan I'm on the F. T E N E. M E. We plan to advance this initiative, while oak holding our established cost model.

Jennifer Simpson: Currently we intend to explore ways to maximize the value of this asset.

Jennifer Simpson: Moving on to the PACE trial, our Phase 3 double-blind placebo-controlled study of some POVI aims to prevent the recurrence of high-risk adenomas and second primary colorectal cancers in patients diagnosed with Stage 0-3 colorectal cancer. As a reminder, the PACEYS trial receives funding from the National Cancer Institute, or NCI, and is being run by the Southwest Oncology Group The study successfully cleared a planned futility analysis, and enrollment is complete.

Jennifer Simpson: Moving on to defeat the pace trial, our phase three double blind placebo controlled study of some tobey.

Jennifer Simpson: Aim to prevent the recurrence of high risk Adenomas and second primary colorectal cancers in patients diagnosed with stage zero to three colorectal cancer.

Jennifer Simpson: As a reminder, the pace trial received funding from the National Cancer Institute or NCI and its being run by the southwest Oncology group also known as toward the <unk>.

Jennifer Simpson: <unk> successfully cleared a planned futility analysis and enrollment is complete.

Jennifer Simpson: We expect data by the second half of 2026. Shifting gears to Phase 2 studies, in July, we announced an agreement with U.S. World Meds to divest assets from the Affluorinazine Pediatric Neuroblastoma Program for non-dilutive payments of up to $9.5 million. Pambela has already received an initial upfront payment of $400,000 and stands to receive further payments as U.S. World Meds achieves key milestones related to Aflorentine's clinical advancement, regulatory approval, and commercial sales. To that end, in December, U.S. World Meds received FDA approval of its new drug application, or NDA, for afluorinathine, marking the first FDA approval of an NDA for any polyamine As mentioned, Pambela benefits financially from this continued advancement of the program.

Jennifer Simpson: We expect data by the second half of 'twenty 'twenty six.

Jennifer Simpson: Shifting gears to phase two study in July we announced an agreement with U S roadmap to divest assets from the authority in pediatric Neuroblastoma program for non dilutive payments of up to $9 5 million.

Jennifer Simpson: And Bell has already received an initial upfront payment of $400000 and stands to receive further payments as the U S. Roadmaps achieved key milestones related to our Florida seems clinical advancement regulatory approval and commercial sales.

Jennifer Simpson: To that end in December U S. Roadmaps received FDA approval for its new drug application or NDA for warranty, marking the first FDA approval of an NDA for any poly mean targeted therapy and a cancer indication.

Jennifer Simpson: As mentioned Pandora benefits financially from this continued advancement of the program.

Jennifer Simpson: Additionally, this approval validates the role polyamines can play in cancer therapy as we look forward to data from our ongoing programs that we are discussing today in metastatic pancreatic cancer, colorectal cancer, non-small cell lung cancer, and prostate cancer, as well as the advancement of preclinical programs in ovarian cancer and multiple myeloma, as well as continuing with Phase 2 trials. In September, we entered into a clinical trial agreement for a phase two trial in castration-resistant metastatic prostate cancer, or CRPC. Leveraging preclinical models that demonstrate a potential role for polyamines in androgen-resistant prostate cancers, this clinical trial will determine if the addition of flornithine to the treatment regimen will demonstrate further efficacy in these difficult-to-treat patients.

Jennifer Simpson: Additionally, this approval validates the role poly means can play in cancer therapy, as we look forward to data from our ongoing programs that we are discussing today in metastatic pancreatic cancer colorectal cancer, non small cell lung cancer and prostate cancer as well as the advancement of preclinical programs in ovarian cancer.

Jennifer Simpson: In multiple myeloma.

Jennifer Simpson: Continuing with phase two trials in.

Jennifer Simpson: In September we entered into a clinical trial agreement for a phase two trial in castration resistant metastatic prostate cancer or C. R. P C.

Jennifer Simpson: Leveraging preclinical models that demonstrate a potential real propelling means in androgen resistant prostate cancers. This clinical trial will determine if the addition of authority to the treatment regimen will demonstrate further efficacy in these difficult to treat patients.

Jennifer Simpson: The study is actively enrolling. Staying with Phase 2 investigations, the Phase 2 trial for CPP1x or aflorinidine is led by Indiana University School of Medicine and is financially supported by the Juvenile Diabetes Research Foundation or JVRF. Results show that DFMO or fornitine treatment may preserve beta cell function reflected by C-peptide levels in patients with type 1 diabetes through the modulation of urinary polymines, in particular put

Jennifer Simpson: The study is actively enrolling.

Staying with phase two investigation the phase two trial for CPP onex or a foreign Athene is led by Indiana University School of Medicine, and financially supported by the juvenile diabetes Research Foundation or Judy Ross.

Jennifer Simpson: Results show that T. S M O or for anything treatment may preserved beta cell function reflected by C peptide levels in patients with type one diabetes through the modulation of urinary poly needs in particular future thing.

Jennifer Simpson: There is a pressing need for the development of safe and effective treatments addressing the underlying cause of early-stage disease, and we are thrilled to champion this initiative with JDRF and the Indiana University School of Medicine. This trial continues to enroll patients. As a reminder, the study referred to as the TADPOL study is a multicenter, double-blind, placebo-controlled, two-to-one random assigned phase two trial for individuals with recent onset type 1 diabetes.

Jennifer Simpson: There is a pressing need for the development of safe and effective treatments addressing the underlying cause of early stage disease and we are thrilled to champion. This initiative with J D. A raft and the Indiana, Indiana University School of Medicine.

Jennifer Simpson: This trial continues to enroll patients as a reminder, this study referred to as the Tadpole study is a multi center double blind placebo controlled two to one random assigned phase two trial for individuals with recent onset type one diabetes.

Jennifer Simpson: The study is enrolling approximately 70 patients, and an interim analysis is anticipated next year. In Phase 1 development, we have three programs that we plan to initiate. We are currently engaged in a clinical trial collaboration with Moffitt Cancer Center for a Phase I-II program designed specifically for patients with STIK11 mutant non-small cell lung cancer. In the phase one trial's initial stages, our objective is to determine the maximum tolerated dose of aflirazine in conjunction with pembrolizumab while simultaneously evaluating its efficacy.

Jennifer Simpson: The study is enrolling approximately 70 patients and an interim analysis is anticipated next year.

Jennifer Simpson: In phase one development, we have three programs that we plan to initiate.

We are currently engaged in a clinical trial collaboration with Moffitt cancer Center for a phase <unk> program designed specifically for patients with stick 11 mutant non small cell lung cancer.

Jennifer Simpson: In the phase one trials initial stages, our objective is to determine the maximum tolerated dose before athene in conjunction with pepper lose a mab will simultaneously evaluating its efficacy.

Jennifer Simpson: Following this phase, our intention is to advance into a Phase 2 trial to further assess effectiveness. The study is open to screening patients, and we anticipate enrolling our first patient in the first half of this year, with plans to initiate the Phase II trial in the latter half of the year. Our second phase one program, scheduled to begin in the first half of this year, will focus on evaluating ibuprofen in the platinum-resistant ovarian cancer population. This endeavor underscores the ongoing collaboration between the company and Johns Hopkins University School of Medicine. Third, we are also engaged in an ongoing collaborative research initiative with the University of Texas MD Anderson Cancer Center focusing on evaluating polyamine metabolic inhibitor therapies along with CAR T-cell therapies and bispecific monoclonal antibodies in preclinical models.

Jennifer Simpson: Following this phase our intention is to advance into a phase two trial to further assess effectiveness.

Jennifer Simpson: The study is open and screening patients and we anticipate enrolling your first patient in the first half of this year with plans to initiate the phase two trial in the latter half of beer.

Jennifer Simpson: Our second phase one program scheduled to begin in the first half of this year.

Jennifer Simpson: Well focus on evaluating either birman in the platinum resistant ovarian cancer population.

Jennifer Simpson: This endeavor underscores the ongoing collaboration between the company and Johns Hopkins University School of Medicine.

Jennifer Simpson: Third we are also engaged in an ongoing collaborative research initiative with the University of Texas, MD Anderson cancer Center, focusing on evaluating poly mean metabolic inhibitor therapy, along car T cell therapies and by specific monoclonal antibodies in preclinical models.

Jennifer Simpson: Recently, we announced the acceptance of an abstract detailing research on SBP 101, or ibosemin, and CPP1X, a fluorinathine, in multiple myeloma cell lines for online publication at the American Society of Hematology meeting, or ASH meeting, and it was included in the November supplemental issue of the journal Blood. PAMBELLA's new programs place a focus on the modulation of Our initial clinical proof of concept involves polymine-targeted therapy combined with a checkpoint inhibitor for patients with STIK11 mutant non-muscle lung cancer. We are excited about expanding this research collaboration to explore the potential benefits of polyamines in immune modulation for hematologic malignancies.

Jennifer Simpson: Recently, we announced the acceptance of an abstract detailing research on S. E T 101, or other spending and CPP Onex, a Florida thing in multiple myeloma cell lines for online publication at the American Society of Hematology meeting or Ash meeting and it was included in the November supplemental issue of the journal blood.

Jennifer Simpson: Pembina was new programs place focus on the modulation of the immune system by poly means our initial clinical proof of concept involves cleaning targeted therapy combined with a checkpoint inhibitor for patients with stick 11 mutant non small cell lung cancer.

Jennifer Simpson: We are excited about expanding this research collaboration to explore the potential benefits of poly means in immune modulation for hematologic malignancies.

Jennifer Simpson: Finally, we are currently engaged in collaborative efforts with key opinion leaders to start the new adjuvant pancreatic investigator initiative. We are in the advanced stages of securing the necessary institutional approvals to initiate the trial in the first half of this year. Turning briefly to our intellectual property or IP efforts, we strengthen our portfolio by announcing the issuance of new patents in China, Australia, and Europe. These patents cover claims on a novel process for the production of SBP-101, a product developed in collaboration with Fingen International Limited.

Jennifer Simpson: Finally, we are currently engaged in collaborative efforts with key opinion leaders to start the neo adjuvant pancreatic investigator initiative. We are in the advanced stages of securing the necessary institutional approval to initiate the trial in the first half of this year.

Jennifer Simpson: Turning briefly to our intellectual property or IP effort, we strengthened our portfolio by announcing the issuance of new patents in China, Australia and Europe.

Jennifer Simpson: Patent cover claims of a novel process for the production of S. E. T 101, a product developed in collaboration with Celgene International Ltd.

Jennifer Simpson: In closing, our unwavering commitment is to advance our development program for the benefit of patients worldwide. To summarize our projected milestones, we expect in the first half of 2024 to open the neoadjuvant pancreatic cancer trial, enroll our first patient in the non-small cell lung cancer phase one trial, open the Phase 1 ovarian trial, announce gastric cancer prevention phase 2 results, publication of the final Phase 1.1b metastatic pancreatic trial data, and the overall survival interim analysis of the Phase 3 ASPIRE trial, which we However, with not enough events or deaths at present, we are working to evaluate the data so that we may update the projected timing. And in the second half of 2024, we anticipate to obtain feedback from the FDA and EMA for global registration of FAP and to open the non-spousal phase two trial, non-spousal lung cancer phase two trial. In summary, the fourth quarter and year to date have marked significant strides for PAMBELLA. We are enthusiastic about the ongoing creation of value for our shareholders as we progress in 2024. I will now turn it over to Sue. Thank you, Jennifer.

Jennifer Simpson: In closing our unyielding commitment is to advance our development program for the benefit of patients worldwide.

Jennifer Simpson: To summarize our projected milestones we expect in the first half of 'twenty 'twenty four to open the neo adjuvant pancreatic cancer trial enroll our first patient in the non small cell lung cancer phase one trial to.

Jennifer Simpson: Open the phase one ovarian trial.

Jennifer Simpson: Announced gastric cancer prevention phase two results.

Jennifer Simpson: Publication of the final phase <unk> metastatic pancreatic trial data.

Jennifer Simpson: And the overall survival interim analysis of the phase III aspire trial, which we originally projected for the middle of 'twenty 'twenty four.

Jennifer Simpson: However, with not enough events or deaths. The present, we are working to evaluate the data that we may update the projected timing.

And then the second half of 'twenty 'twenty four we anticipate to obtain feedback from the FDA and EMA for global registration.

Jennifer Simpson: In S E T.

Jennifer Simpson: And to open the non muscle phase two trial not supposed to lung cancer phase two trial in summary, the fourth quarter and year to date have marked significant strides for Pam Butler, we are enthusiastic about the ongoing creation of value for our shareholders as we progress in 2024.

Jennifer Simpson: I will now turn it over to Sue.

Sue Horvath: Thank you Jennifer.

Sue Horvath: No and administrative expenses were 0.9 billion in the fourth quarter of 2023 compared to one 7 million in the fourth quarter of 2020 Chi.

Sue Horvath: General and administrative expenses were $0.9 million in the fourth quarter of 2023, compared to $1.7 million in the fourth quarter of 2022. This decreases the result of lower professional fees in 2023 versus 2022. Research and development expenses were $6.1 million in the fourth quarter of 2023, compared to $3.5 million in the fourth quarter of 2022. The increase is primarily due to increased activity in the ASPIRE trial. All share and per share amounts of our common stock presented here and in our report 10-K have been retroactively adjusted to reflect the reverse stock splits completed in January of 2024 as well as those that occurred in 2023. The net loss in the fourth quarter of 2023 was $6.5 million or $65.90 per diluted share compared to a net loss of $4.7 million or $344.61 per diluted share in the fourth quarter of 2022.

Sue Horvath: This decrease is the result of lower professional fees in 2023 versus 2022.

Sue Horvath: Research and development expenses were $6 1 million in the fourth quarter of 2023 compared to $3 5 million in the fourth quarter of 2022.

Sue Horvath: The increase is primarily due to the increased activity in the aspire trial.

Sue Horvath: All share and per share amounts of our common stock from China here and in our report 10-K have been retroactively adjusted to reflect the reverse stock split completed in January of 2024, as well as those that occurred in 2023.

Sue Horvath: Net loss in the fourth quarter of 2023, with $6 5 million or $65 at 90 cents per diluted share compared to a net loss of 4.7 million or $344.61 per diluted share in the fourth quarter of 2022.

Sue Horvath: Total cash was approximately $2 6 million as of December 31, 2023, which does not include proceeds from the $9 million public offering we closed in January.

Sue Horvath: Total cash was approximately $2.6 million as of December 31, 2023, which does not include proceeds from the $9 million public offering we closed in January. Total current assets were $3.1 million, and current liabilities were $12.3 million as of the end of the quarter on December 31, 2023. Total non-current assets, consisting primarily of cash deposits held by our contract research organization, were $8.7 million, as a result of the CPP acquisition. In Q2 of 2022, we added debt and accrued interest to our balance sheet. However, during the quarter ended December 31st, 2023, no debt or interest payments were due or paid.

Sue Horvath: Total current assets were $3 1 million and current liabilities were $12 3 million as of the end of the quarter.

Sue Horvath: December 31st 2023.

Sue Horvath: Total non current assets, consisting primarily of cash deposits held by our contract research organization were $8 7 million.

Sue Horvath: As a result of the C. P. P acquisition in Q2 of 2022 we added debt and accrued interest to our balance sheet.

Sue Horvath: During the quarter ended December 31st 2023, no debt, our interest payments, where d'you or page.

Sue Horvath: The principal balance remaining on the notes is $5.2 million, and there was approximately $238,000 of accrued interest, accrued in unpaid interest as of that date. The current portion of $1 million plus the accrued interest was paid, per the terms of the note earlier this month. Looking to the cap table. First, a reminder, all shares have been retroactively restated for the reverse split that occurred on January 18. As of December 31st, 2023, we had approximately 480,000 common shares out, and including shares reserved for options and warrants, we were at a total of approximately 826,000 shares. The number of shares reserved includes all outstanding equity awards, including stock options, which were held primarily by insiders, and all warrants to purchase common stock.

Sue Horvath: The principal balance remaining on the notes is $5 2 million and there was approximately 238000 of accrued interest.

Sue Horvath: The accrued and unpaid interest as of that date.

Sue Horvath: The current portion of 1 million plus the accrued interest was paid per the terms of the note earlier this month.

Sue Horvath: Looking to the cap table first a reminder, all shares had been retroactively restated for the reverse split that occurred on January 18th.

Sue Horvath: As of December 31, 2023, we had approximately 480000 common shares outstanding and.

Sue Horvath: Including shares reserved for options and warrants we were at a total of approximately 826000 shares.

Sue Horvath: 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.

Sue Horvath: Our cash used in operations for the year ended December 31st, 2023 totaled approximately $25.2 million. This cash used in operations for the year ended December 31st, 2023 included approximately 3.7 million in payments necessary to secure a supply of standard of care chemotherapy agents for the ASPIRE trial as well as 2 million in the total payments made to increase those deposits held by our CRO for future clinical trial costs. On December 2nd, 2023 and December 21st, 2023, the company induced certain warrant holders to exercise their warrants for cash; gross proceeds received from this exercise totaled approximately $1.9 million and $2 million, respectively. In January of this year, we closed a $9 million public offering consisting of 4,375,000 shares of its common stock or pre-funded warrants in lieu thereof, and two classes of warrants to purchase up to an aggregate of 8,7 Those warrants will have an exercise price of $2.06 per share, are exercisable upon issuance, and will expire five years following the date of issuance.

Sue Horvath: Our cash used in operations for the year ended December 31st 20 tracery totaled approximately $25 2 million.

Sue Horvath: Cash used in operations for the year ended December 31, 2023 included approximately $3 7 million in payments necessary to secure a supply of standard of care chemotherapy agents for the aspire trial.

Sue Horvath: As well as $2 million.

Sue Horvath: In the total payments made to increase those deposits held by our Cerro for future clinical trial costs.

Sue Horvath: Yeah.

Sue Horvath: On December 2nd 'twenty, 'twenty, three and December 21st 2023, the company induced certain certain warrant holders to exercise their warrants for cash.

Sue Horvath: Gross proceeds received from this exercise totalled approximately 1.9 billion and 2 million respectively.

Sue Horvath: Yeah.

Sue Horvath: In January of this year, we closed a 9 million dollar public offering.

Sue Horvath: Feet of four 4.375 million shares of its common stock or pre funded warrants in lieu thereof, and two classes of warrants to purchase up to an aggregate of 8.750 million shares of common stock.

At a purchase price of $2.06 per share plus the associated warrants.

Sue Horvath: Those warrants will have an exercise price of $2.06 per share are exercisable upon issuance and will expire five years following the date of issuance.

Sue Horvath: The net proceeds on this offering were approximately $8.2 million. Pembella's common stock is listed on the NASDAQ Stock Market Exchange under the symbol PBLA, but it is currently trading on the OTC pink sheets under that same technology. The company is currently pursuing a new listing of its common stock on a national securities exchange. Operator, can you please open the phone lines now for Q&A and poll for questions?

Sue Horvath: The net proceeds of this offering was approximately $8 2 million.

Sue Horvath: And that was common stock is listed on the NASDAQ stock market exchange under the symbol P. D. L. A but it is currently trading on the OTC pink sheets under that same kicker.

Sue Horvath: The company is currently pursuing in new listing of its common stock on a national Securities Exchange.

Speaker Change: Operator can you. Please open the phone lines now for Q&A and poll for questions.

Speaker Change: 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.

Operator: We'll be conducting, and Anand. If you would like to ask a question, please press star 1 on your telephone. An information tone will indicate that you may press star 2 if you would like to remove the speaker.

Speaker Change: Information tone will indicate your line is in the question queue.

Speaker Change: You May press star two if he would like to remove your question from the queue.

Speaker Change: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Operator: Thank you. Hello Jennifer and Susan, good afternoon.

Speaker Change: Ken That's a star one if you wish to ask a question at this time I'm. Please hold while we poll for questions.

Caller (Jonathan): I have a few questions. What's the FAP trial going to cost you? Hi Jonathan.

Speaker Change: On the first question today is coming from Jonathan Aschoff from Roth M Cat Jonathan Your line is live.

Jonathan Aschoff: Thank you Oh, Jennifer and Susan.

Jonathan Aschoff: Good afternoon, I have a few questions what's.

Jennifer Simpson: Good afternoon. I'm sorry, which trial? I apologize; I didn't hear that one. The Phase III SAP trial that you need to get regulatory guidance and clearance on. Oh, gotcha, gotcha. So for the FAP trial, that is a program that once we have agreement on the global registration path, we'll most likely be seeking a partner for that program. So for us, we are trying to remain cost neutral on that one while moving that asset forward. Okay, that's definitely clear. You know, can I ask you, you know, if a Florida thing gets approved, could you elaborate on the financial, the actual direct financial benefit to Pandela for that?

Jonathan Aschoff: What's the snap trial garner costs do you think.

Jonathan Aschoff: Yes.

Speaker Change: Let's say hi, Jonathan good afternoon, I'm, sorry, which trial.

Jonathan Aschoff: Part of this here that one three.

Jonathan Aschoff: Phase III trial that you need to get regulatory guidance and clearance on Oh Gotcha Gotcha. So for the pretty upbeat T trial and that is the program that once we have agreements on the global registration path.

Jonathan Aschoff: Most likely we'll be seeking a partner for that program.

So for US we're trying to remain cost neutral on that one while moving the asset forward.

Okay, that's clear.

Speaker Change: Clear Yeah can I ask you Oh.

Speaker Change: If a Florida seen approved so could you elaborate on the financial the actual direct financial benefit depends elder for them.

Jennifer Simpson: Yes, so with the approvals, obviously, the first approval was for the Neuroblastoma program that we divested to U.S. World Med. And so with that program, there was a $400,000 upfront payment, and then there's a total of another $9.1 million in non-dilutive milestones, mostly tied to commercial sales, both in the U.S. and Europe, as well as an ongoing trial in the Children's So just as a quick reminder, the first approval was in the maintenance setting.

Speaker Change: Yeah, so with the approval to the obviously the first approval was in the Neuroblastoma program that we divested two U S World men.

Speaker Change: And so with that program there was a $400000 upfront payment and then there's a total of another $9 1 million in non dilutive milestones.

Speaker Change: Mostly tied to the.

Speaker Change: Commercial sales are both U S and Europe as well as there's an ongoing Ah trial in the children's oncology group in the first line setting of neuroblastoma. So it just as a quick reminder, the first approval was in the maintenance setting.

Jennifer Simpson: And so as that current trial moves forward, which went to U.S. World Med as part of our agreement, there are regulatory milestones around that trial as well. So we are anticipating that, you know, probably between the end of the second half of this year and the first half of next year, we will start to see some of those milestone payments come in, probably to the tune of, you know, half a million to a million to start, and then they ramp up as sales continue. Okay, that is very helpful. Thank you. Given the R&D level fluctuations, can you help us out with how R&D will look in 2024? in terms of financials.

Speaker Change: And so as that current trial moves forward, which went to U S World, Matt as part of our agreement I'm.

Speaker Change: There are regulatory milestones.

Speaker Change: Milestones around that trial as well.

Speaker Change: So we are anticipating that.

Speaker Change: Probably between the end of second half of this year and first half of next year, we will start to see some of those milestone payments come in probably to the tune of you know half millions to a million to start and then they ramp up as our sales continue.

Speaker Change: Okay. That's very helpful. Thank.

Speaker Change: Thank you.

Speaker Change: Orange juice.

Speaker Change: Level fluctuations can you help us out with how the R&D looks over 'twenty 'twenty four.

Speaker Change: Yes.

Speaker Change: And ear of a program of financials now because that'll be a few question [laughter].

Sue Horvath: I was going to say that it would be a two-question answer. Yes. Are we going to stay in the sixes or go higher?

Speaker Change: Yeah Yeah.

Speaker Change: Or would you say you're in the six isn't go higher.

Sue Horvath: Yeah, right now we're projecting that between six and quarter for the total burden for the company, so that would include the modest spending we do on GNA and then the balances R&D, and almost all of that really is the ASPIRE trial. The other thing that affected us last year was the need to secure standard of care chemotherapy agents for the trial. That wasn't expected.

Speaker Change: Yeah, right now, we're projecting that between six and six and a half per quarter for the the total burden.

Speaker Change: For the company so that would include the modest.

Speaker Change: Modest spending than we do out of G&A and then the balance is R&D and almost all of that really is the aspire trial.

Speaker Change: The other thing that.

Speaker Change: Affected us last year was the need to secure.

Speaker Change: Third of care.

Speaker Change: Chemotherapy agents for the trial that wasn't expected that will also continue we just have to determine at what level that will impact the numbers.

Sue Horvath: That will also continue; we just have to determine at what level that will impact the numbers. Yeah, I think, Jonathan, if I could add just one more thing, too. I think it's really important, you know, the ASPIRE trial. As Sue mentioned, the primary driver of our cash needs is the ASPIRE trial.

Speaker Change: Yeah, I think Jonathan if I might add just one more thing too I think it's really important.

Speaker Change: The aspire trial as Sue mentioned the primary driver of our cash needs is the aspire trial you know it is a 600.

Jennifer Simpson: You know, it is a 600-patient, you know, approximately 600-patient trial, randomized, double-blind, placebo-controlled. The other programs that we went through, it's quite an extensive pipeline. We are very fortunate to have funding for almost all those programs from other sources. So I think that's an important distinction. You know, a lot of times when you have a company with so many programs, the cash needs are split across those programs, and we really have a main driver and are fortunate to have all these other programs in conjunction with funding from other sources.

Speaker Change: Approximately 600 patient trial randomized double blind placebo control the other programs that we went through it's quite extensive.

Speaker Change: Extensive pipeline.

Speaker Change: We are very fortunate to have funding for almost all of those programs from from other sources. So I think that's a unimportant distinction you know a lot of times when you have a company with so many programs.

Speaker Change: The cash needs are split across those programs and we really have a main driver and are fortunate to.

Speaker Change: We have all these other programs in conjunction with our funding.

Speaker Change: Funding from other sources.

Jennifer Simpson: Okay, that was helpful. And lastly, can you tell us about the exchange that you might go to given the delisting? You know, it doesn't have to be the pink sheets; isn't there a far more favorable option? Do you want to take that, or do you want to take it?

Speaker Change: Okay.

Helpful. And lastly, you know can you tell us about.

Speaker Change: The extremes that you might have.

Speaker Change: Go to given the delisting yeah. It doesn't have to be the pinksheets isn't there with four or more favorable option perhaps.

Speaker Change: Did you want me to take that or do you want to take it yeah. I mean I can tell you that yes, certainly I mean, the pink sheets or a temporary place for us to be likely.

Sue Horvath: Yeah, I can take it, yes. Certainly, I mean the pink sheets are a temporary place, and likely, even the OTC QB will be, you know, not necessarily a long-term solution either. We need to be on a national exchange. You know, so there's, we're looking at all of the others that we might be able to up-list too. That might include the CBOE, the American, that was NYFC, are a couple of the options that we're looking at. Well, what seems to maybe provide the most, you know, the potential for the most liquidity, do you think? Do you think the CBOE is the best of between that and Amex? In our research, what we found is that the volume on the CBOE tends to be very close to what's seen on NASDAQ, so if that's the primary driver for our decision, that might be the right place to go.

Speaker Change: Likely even the OTC QB will be not necessarily a long term solution either we need to be on the national exchange. Yeah. So there's we're looking at all of the others.

Speaker Change: That that we might be able to uplift to that might include the CBOE.

Speaker Change: American on that was.

Speaker Change: The NYSE.

Speaker Change: A couple of the options that we're looking at.

Speaker Change: What seems to maybe provide the most you know the.

Speaker Change: The potential for the most liquidity you think you'd think the CBOE as the best of between that dynamics.

In our research what we found is that the volume on the CBOE tends to be very close to what you're seeing on NASDAQ. So.

Speaker Change: Yep.

Speaker Change: If that's the primary driver for our decision that might be the right place to go.

Sue Horvath: Okay, thank you very much. Thank you so much, Jonathan. Show. Thank you. Hi, this is Josh on behalf of Joe.

Speaker Change: Okay.

Speaker Change: Thank you very much.

Speaker Change: Thank you so much Jonathan.

Speaker Change: Thank you and the next question is coming from Joe <unk> from H C. Wainwright, Joe Your line of lives.

Speaker Change: Thank you Hi, this is Josh on for Joe.

Caller (Josh): I just had two quick questions. So for the first one, I believe last quarter it was maybe said that we would potentially see some data in 2024 for the phase one stick 11 trial. Now, just wondering, now that the first patients are being enrolled in the first half of 2024, do we still expect that? Or would that potentially be pushed back?

Josh: I just have two quick questions. So for the first one I believe last quarter. It was made you said that we would potentially see some data in 2024 for the phase ones took 11 trial I was just wondering now with the first patients being enrolled in the first half of 'twenty 'twenty four do we still expect out of it.

Josh: Would that potentially be pushed back and then just quickly I think I've missed it about the phase one study in platinum resistant ovarian cancer I was just wondering if you could reiterate one that is set to begin.

Jennifer Simpson: And then just quickly, I think I missed it about the phase one study in platinum-resistant ovarian cancer. I was just wondering if you could reiterate when that is set to begin. Yeah, absolutely. And thanks so much, Josh.

Speaker Change: Yeah, absolutely and thanks, so much Josh so.

Jennifer Simpson: So for the SICK-11 mutant phase one, since the trial is open and screening patients now, we would most likely have data towards the end of this year. And that would then feed into the start of the phase two portion. As of right now, that is our current projection. We're going to have to see how enrollment goes. You know, as a reminder, the SICK-11 mutant population of non-small cell lung cancer, depending on which source you look at, ranges between 10 and 30% of lung cancers.

Speaker Change: So for the thick 11 mutant phase one since the trial is open and screening for patients now we would most likely have data towards the end of this year and that would then feed into the start of the phase two portion.

Speaker Change: As of right now that is our current projection we're gonna have to see how the enrollment goes you know as a reminder, the stick 11 mutant population of non small cell lung cancer, depending on which source you look at ranges between 10 and 30% of of our lung cancers.

Jennifer Simpson: But I will say, you know, Moffitt's been actively screening. And so as enrollment starts, we will keep everyone updated on the progress. But our hope right now is to have data from that by the end of the year. For ovarian cancer, we have been working very closely with Johns Hopkins University School of Medicine and looking to finalize that protocol and have that phase one program open by the first half of this year. And it's interesting because we're looking at a number of trial designs, and it could end up being phase two instead of phase one, depending on which path we take. But we have a very engaged team. So we look forward to finalizing that and updating everyone accordingly. Thank you for answering my questions and thank you for the update. Yeah, thank you so much, and that also concludes today's show.

Speaker Change: But I will say you know market, but actively screening and so is it as enrollment starts.

Speaker Change: We will keep everyone updated on the progress.

Speaker Change: But our hope right now is that I'm from that is that by the end of the year.

For the ovarian cancer.

Speaker Change: We have been working very closely with Johns Hopkins University School of Medicine, I am and looking to finalize that protocol and have that phase one program open by the first half of this year and it it's interesting because we're looking at a number of trial designs and it could end up being a phase two instead of a phase.

Speaker Change: One, depending on which which path we take but we have a very engaged team. So we look forward to finalizing that and and updating everyone. Accordingly.

Speaker Change: Perfect. Thank you for answering my questions and thank you for the update.

Speaker Change: Yep. Thank you so much.

Speaker Change: Thank you. This does conclude the Q&A session and also concludes today's conference you may disconnect. Your lines at this time and thank you for your participation.