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spk02: Good day, and welcome to the PanBella Therapeutics first quarter 2023 earnings call. At this time, all participants have been placed on a listen-only mode, and the floor will be open 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.
spk04: Thank you, Operator. With me on the call are Jennifer Simpson, Chief Executive Officer, and Sue Horvath, 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 company's annual report on Form 10-K and supplemented by subsequently filed 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 Panvelna. Jennifer, please proceed.
spk01: 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. Sue will then follow with a review of the financial results, and then we will open it up for Q&A. Starting with our phase three program, 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 ibuprofen or SCP-101 in combination with gemcitabine and nab paclitaxel in patients with untreated metastatic pancreatic ductal adenocarcinoma. We continue global enrollment and are focused on the country and site initiations for the ASPIRE trial as we aim to have the full complement of sites on board by the middle of this year. Having 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 EMAs, Committee for Orphan Medicinal Products issued the Adoption of Commission Implementing Decision relating to the designation of IVAL-7 as an orphan medicinal product in combination with gemcitabine and nabpaclitaxel in patients with metastatic pancreatic ductal adenocarcinoma. Medicines that meet the EMA's orphan designation criteria may qualify for financial and regulatory incentives, including a 10-year period of marketing exclusivity in the EU after product approval, product assistance from the EMA at reduced fees during the product development phase, and access to centralized marketing authorization. Turning to familial ad nominus polyposis, or FAP. In April, we learned that we will regain the North American rights to develop and commercialize Lympovy, which is the combination of a Flornithine and Sulandec in patients with FAP as a result of the pending termination of the licensing agreement between Cancer Prevention Pharmaceuticals, or CPP, and 1-2 Therapeutics Assets Limited. PAMBELLA is now positioned to take the lead on designing the global trial protocol and presenting it to the Federal Drug Administration, or FDA, and the EMA for agreement on the registration pathway. By leveraging PAMBELLA's extensive experience with FAP 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 Sympovy in the treatment of FAP. This approach will help achieve global regulatory approval and a successful launch of Sympovy in the global market. We expect this new registration trial will focus on FAP patients who have intact lower gastrointestinal anatomy and will build upon the positive results from the FAP310 trial that were published in the New England Journal of Medicine by Burke et al. in 2020 and disease of the colon and rectum by Ballaguer et al. in 2022. That study showed 100% risk reduction in the need for surgery in patients with an intact lower gastrointestinal anatomy with Flimpovy versus a Flortithine or Sulandac alone. We believe the FAP310 trial data is compelling and the new registration trial could lead to the approval of Flimpovy. Since there are currently no approved drug therapies for the treatment of FAP, this therapeutic option has the potential to impact this urgent unmet global need for patients with FAP. We are confident that the new FAP registration trial will have the potential to provide a non-surgical treatment option to both physicians and their patients with FAP. Tambella is committed to working collaboratively with the FDA, EMA, and the FAP community to advance this program and to ultimately provide a new treatment option for FAP patients. We are excited to regain the worldwide rights to phlegm phobia for FAP patients and believe our internal expertise, experience with health authorities, relationship with FAP experts throughout the U.S. and Europe, and our commitment to FAP patients and their families in combination with the positive results from the prior FAP 310 trial This gives 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 we'll evaluate opportunities to maximize the value of this asset. Finally, we move to the phase three double-blind placebo-controlled trial of Sympovy to prevent recurrence of high-risk adenomas and second primary colorectal cancers in patients with stage 0 to 3 colon or rectal cancer. This trial, known as the PACES trial, is funded by the National Cancer Institute, or NCI, in collaboration with the Southwest Oncology Group, also known as SWOG, and we look forward to a futility analysis in the first half of 2023. Moving to phase two studies. First, there is an ongoing trial in relapsed refractory neuroblastoma utilizing a fluorethane sachet. This trial is funded through the Children's Oncology Group, or COG, and the NCI. We also enrolled our first patient in a phase two, double-blind, randomized study to evaluate CPP1XT, or a fluorethane tablet, for recent onset type 1 diabetes. We are excited to have the first patient enrolled in the phase two trial for CPP1XT, led by Indiana University School of Medicine and funded by the Juvenile Diabetes Research Foundation, or JDRF, the leading global organization advancing life-changing breakthroughs for type 1 diabetes. There are some 1.45 million Americans living with type 1 diabetes in the U.S., and there is approximately $16 billion in type 1 diabetes-associated healthcare expenditures and lost income annually. We are excited for the opportunity to test and validate our therapy in type 1 diabetes and the potential of this phase 2 trial to provide better treatment options for this patient population. Additionally, we recently announced that abstracts about CPP1X research, also known as CFMO or fornitine, have been accepted for poster presentations at the Immunology of Diabetes Society, or IDS, meeting, which will be held May 23rd through the 27th of 2023. And at the Endocrine Society meeting, which will be held June 15th through the 18th, 2023. In phase one development, we have three programs that we'll be starting. First, a fluorethane sachet will be evaluated in combination with Keytruda in the STIC11 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 Ivo7 in the platinum resistant ovarian cancer population. We recently presented a poster titled, Evaluating the Efficacy of Sperming Analog Isla-7 SBP101 in Combination with Chemotherapy in Ovarian Cancer at the American Association for Clinical Research, or AACR, meeting April 14th through the 19th of this year. The poster highlights the efficacy of SBP101 in combination with the standard of care chemotherapy agents used to treat platinum-resistant ovarian cancer. Treatment with gemcitabine, topotecan, and doxorubicin have been shown to significantly increase the in vitro toxicity of SBP101 in both cisplatin sensitive as well as cisplatin resistant ovarian cancer cell lines. Paclitaxel and dositaxel have been shown to not have any added benefit in vitro to SBP101 alone. Utilizing the VDID8 positive murine ovarian cancer model, The efficacy of SVP-101 in combination with either gemcitabine, topotecan, or doxorubicin was evaluated. Gemcitabine and topotecan alone had little effect on the overall survival of the mice, whereas either SVP-101 or doxorubicin treatment alone significantly increased median mouse survival time. The addition of SVP-101 improved the survival of mice treated with any of the three chemotherapeutic. The SDP-101 and doxorubicin combination mice have the greatest survival time, with a 265% increase in median survival compared to untreated animals. Additionally, combining DFMO or aphornidine with ibuprofen in vitro resulted in a cooperative anti-proliferative response. DFMO has been shown to be well-tolerated and can influence immune cells to promote a more immune-friendly tumor microenvironment. Future experiments will evaluate the effect of adding DFMO to IVOS-7 treatment, as well as the influence on immune cells within the tumor microenvironment. The poster concludes that the treatment of mice containing VDID-A-positive ovarian cancer with SBP101 in combination with doxorubicin significantly prolonged survival and decreased overall tumor burden. Future studies will be designed to evaluate the effects of SBP101 in combination with other polyamine metabolism modulators, as well as with immune modulators. The results suggest that SVP101 in combination with doxorubicin 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. The collaboration is intended to expand the development of Pamela's investigative agents, Ivalosfemin and Aflornithine, including activity and models of ovarian and other cancer types, further evaluations into mechanism of action, and potential combination of Ivalosfemin with Aflornithine and standard of care agents. Last, we are continuing to work with the key opinion leaders to finalize the neoadjuvant pancreatic cancer investigator-initiated protocol and obtain the necessary institutional approvals 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 STIC-11 phase 1 trial, Futility analysis from the SWOG colon cancer risk reduction trial. The opening of the neoadjuvant trial and the ovarian cancer trial. Agreement of the FDA and EMA on a registration protocol for FAP. 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 I programs in both first-line metastatic pancreatic cancer as well as early-onset type 1 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.
spk00: 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 CPP acquisition. Research and development expenses were $3.5 million 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 Aspire clinical trial. On January 13, 2023, we affected a reverse stock split at a ratio of 1 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 10Q have been retroactively adjusted to reflect the 1 for 40 reverse stock split. Net loss in the first quarter of 2023 was $5.1 million or $0.65 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 31, 2023. Total current assets were $7.8 million And current liabilities were $9.7 million as of the end of the quarter. On March 31, 2023, total non-current assets consisting primarily of cash deposits held by our contract research organization was $8.6 million. During the quarter, we completed a public offering for gross proceeds of approximately $15 million. As a result of the CPP 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 of approximately $295,000 was paid on the note with an original balance of $6.2 million. The principal balance now on this note is $5.2 million. Also, during the quarter, the company made a payment of $650,000 in principal and accrued interest of approximately $85,000 on a second note. This note has now been paid in full. Looking at the cap table, as of March 31, 2023, we had approximately 16.1 million common shares outstanding, and including shares reserved for options and warrants, we were at approximately 20.2 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 31st, 2023, totaled approximately 9.8 million. Cash used in operations for the quarter included approximately 2 million in prepayments necessary to secure the supply of standard of care chemotherapy agents for the ASPIRE trial, as well as payments made to obtain current balances with key vendors. As we've discussed, we anticipate that the ongoing cash used in operations will be between five and five and a half 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?
spk02: Thank you. At this time we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. And for participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. Thank you. Our first question is coming from Jonathan Ashoff with Roth MKM.
spk03: Please go ahead. Thank you very much. Hi, guys. Good afternoon. I was wondering, for Aspire, are any new countries to be included for that trial, or will you just open additional sites in currently enrolling countries or stick with the sites you have?
spk01: Yeah. Hi. Good afternoon, Jonathan. You know, 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 on board by roughly the middle of this year. So we're making great progress.
spk03: Okay, great. On FAP, can you tell us anything about securing partners for FAP?
spk01: Yes. You know, so... As we look at this, one of the things that we thought would put us in the best possible position is to secure the approval from both FDA and EMA on a global registration protocol. I think that gives us much more sure footing as we look to see how we can best maximize that asset 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 have a great deal of expertise as well as the relationships with the FAP community, both patients and KOLs. So we feel pretty confident that we'll be able to get this protocol together and through the regulatory bodies hopefully, you know, very soon.
spk03: Okay. That sounds like a good first step. Thank you. Thank you very much.
spk02: Absolutely. Thank you. Once again, if there are any remaining questions or comments, please press star 1 on your phone at this time. Okay. We have no further questions in queue at this time, so this will conclude today's conference. You may disconnect your lines at this time, and we thank you for your participation.
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