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spk05: Ladies and gentlemen, thank you for standing by. Welcome to the Anakova Therapeutics first quarter financial results and business update conference call. At this time, all participants are in listen-only mode. Following management's prepared remarks, we will hold a question and answer session. To ask a question at that time, please press star followed by the number one on your touchtone phone. If anyone has difficulty hearing the conference, Please press star zero for the operator assistance. As a reminder, this call is being recorded today, May 17th, 2021. At this time, I would like to turn the call over to Avi Oler, Senior Vice President of Corporate Development and General Counsel.
spk02: Thank you. Good afternoon, everyone, and welcome to Akanova's first quarter 2021 financial results and business update conference call. Earlier this afternoon, we issued a press release reporting our quarterly financial results and business progress. If you have not yet seen this press release, it is available in the Investors and Media section of our website at www.oncanova.com. On today's call, Dr. Steve Fruchman, our President and CEO, will discuss the company's recent highlights and anticipated clinical and business milestones, and then Mark Guerin, our Chief Financial Officer, will review first quarter financial results. Following Mark's report, we'll move to the Q&A portion of the call, and we'll be joined by Dr. Steve Cosenza, our lead scientist. Before we begin, I'd like to remind everyone that statements made during this conference call by management will include forward-looking statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties that can cause actual results to differ materially. Forward-looking statements speak only as of the date they are made, as the underlying facts and circumstances may change. Except as required by law, Ancanova disclaims any obligation to update these forward-looking statements to reflect future information, events, or circumstances. For more information on forward-looking statements, please review the disclaimer in today's press release and the risk factors in the company's SEC filings. With that, it is my pleasure to now turn the call over to Steve.
spk03: Thank you, Avi. Good afternoon, everyone, and thank you for joining us today. As the COVID-19 pandemic is being brought under greater control in some, but tragically not in all geographies, through the scientific advances of colleagues from around the world, we hope you and your loved ones remain safe and healthy. Despite the hurdles COVID placed on the conduct of clinical research, Ankenova remains committed to executing on our goals and advancing our pipeline candidates through the clinic. Let me begin with a review of our business progress, starting with our lead product, ON123300, or simply referred to as 1, 2, 3. As a reminder, 1, 2, 3 is a proprietary first-in-class multi-kinase inhibitor targeting CDK4, CDK6, and ARK5. It works by simultaneously inhibiting both the cell cycle and cellular metabolism through CDKs and ARK5, respectively, which may be overexpressed in a number of cancers. In vitro data show that 1, 2, 3 may be phytotoxic to cancer cells, meaning it kills cancer cells, rather than merely inhibiting their growth. which is how the currently available CDK inhibitors typically work. We believe that with a mechanism of action targeting CDK4, CDK6, ALK5, and other kinases, such as FLT3, 1, 2, 3 represents an innovative approach for treating solid tumors and hematologic malignancies that are refractory or have become resistant to the current CDK4-6 inhibitors. Additionally, 123 has shown superior CDK4 inhibition and improved oncology toxicity compared widely prescribed second-generation CDK4-6 inhibitor, palbocycline, in a multitude of preclinical studies. We believe this presents an opportunity for continuous daily dosing of 1, 2, 3, which may lead to improved efficacy as palbocycline and another second generation CDK4-6 inhibitor, ribocycline, are prescribed in combination with an anti-estrogen agent in a three weeks on, one week off treatment schedule due to issues of tolerability, including side effects related to neutropenia, thus the need for a one week off scheme. Based on the clinical data mentioned above, suggesting that 1, 2, 3 causes less marrow suppression than pavocyclob does, we plan to evaluate a continuous dosing schedule of 1, 2, 3 in our phase one study in the U.S. We are continuing to advance this study and are delighted to have initiated sites and opened the study for enrollment. We expect to dose the first patient in the study sometime during the second quarter of this year as investigators evaluate patients for inclusion. Progress is continuing with the other ongoing phase one study with our partner in China, Hanx, pharmaceuticals. At this point in China, two dosing cohorts have been completed with one, two, three appearing to be well tolerated with no dose limiting toxicities observed to date. I'm also pleased to announce that the third cohort evaluating a 120 milligram dose in this study is is now open for enrollment. Together, the HANF and U.S. studies aim to provide complementary information that will design the subsequent trials. The HANF study is dosing patients on phase one through 21 of a 28-day cycle, while the U.S. phase one study will evaluate continuous daily dosing as I mentioned already. Our current plan is for the phase one trial in the U.S. to assess the safety, tolerability, and pharmacokinetic profile of 1, 2, 3 administered as a single agent at increasing doses starting at 40 milligrams daily for consecutive 28-day cycles in patients with advanced cancer. This includes but is not limited to patients with hormone receptor positive HER2 negative metastatic breast cancer with resistance to the approved second generation CDK4 and 6 inhibitors. We anticipate a total of three phase one sites in the US and believe the data they generate in conjunction with the phase one data generated in China will establish the recommended dose and treatment regimen for a future phase two basket trial that will enroll patients with several different types of cancer that overexpress the tyrosine kinases targeted by 1, 2, 3, in addition to CDK4 and 6. Based on preclinical models, thus far we have identified two potential target indications for this future basket study. We plan to enroll approximately 36 hormone receptor positive HER2 negative metastatic breast cancer patients who are resistant to the approved second generation CDK4-6 inhibitors, as well as patients diagnosed with advanced non-Hodgkin's lymphoma with a special interest in mantle cell lymphoma. We will continue to be data-driven as we finalize the design of this future trial, integrating the results of preclinical and clinical studies to dictate the additional target indications we will evaluate. We're very excited about 123's potential to improve outcomes for patients compared to the current approved CDK4-6 inhibitors for the indication of hormone receptor positive HER2 negative metastatic breast cancer and in other indications as well. I look forward to announcing further clinical progress from our two ongoing trials throughout this year. We view hormone receptor positive HER2 negative metastatic breast cancer as well as additional potential indications as a large commercial opportunity for 123. Total worldwide sales of the three approved CDK4-6 inhibitors exceeded $6 billion in 2019. I'd like to discuss some of the progress we've seen in several investigator-initiated studies evaluating Rigocertib, our RAS-targeted product candidate, which has also been shown to have the important capacity to promote the tumor infiltration of anti-cancer immune cells in preclinical studies that was presented at the American Association of Cancer Research in 2019. This is an important observation which hopefully will improve patient outcomes when immuno-oncology drugs are prescribed or expand the potential indications of immuno-oncology drugs to tumors lacking the ability to recruit these valuable anti-tumor immune cells. We recently announced that the first patient was dosed in an investigator-initiated Phase II study with rego-certed monotherapy in advanced squamous cell carcinoma associated with recessive dystrophic epidermolysis bullosa, a terrible genetic skin-blistering disease. We are very encouraged by the start of this trial. We hope RegoCert will prove beneficial to this patient population who suffer with a tremendous unmet medical need. The first site for this trial was established at the University Hospital Salzburg in Austria. And additional sites are anticipated to be open in both the UK and the U.S. in the coming months. In this open-label investigator-initiated study, 12 patients will receive either oral or intravenous regoceratop at the clinician's discretion. Physicians will have a choice of route of administration because of the various clinical manifestations of this disease, which may dictate whether oral or intravenous administration of ricocertib is the preferred route. These patients have terrible skin desquamation, which makes intravenous access and administration difficult. And others may have esophageal strictures, which make oral administration difficult. patients will receive either oral regocertib in four-week cycles, including three weeks on, one week off, for up to 13 cycles. Alternatively, patients will receive intravenous regocertib as a 72-hour infusion on days one, two, and three of eight two-week cycles and days one, two, and three of nine four-week cycles Overall, we are very pleased with the clinical milestones achieved with both 1-2-3 and regocertum during the past few months. Very importantly is the progress of a Phase I-II trial in patients with advanced KRAS-mutated non-small cell lung cancer that is being conducted with regocertib in combination with the PD-1 inhibitor nivolumab, more commonly known as Abdevo, provided kindly by Bristol Myers Squibb for this study. This study has the potential to address a critical unmet medical need, as KRAS mutations are the predominant genetic driver of non-small cell lung cancer, and there is currently a lack of effective treatment options for patients who progress on first-line therapy. Checkpoint inhibitors such as Abivo are among the world's top-selling pharmaceutical products, despite some tumor microenvironments lacking the prerequisite of immune cells surrounding or infiltrating the tumor and thus potentially limiting their efficacy. Based on the preclinical findings presented at the AACR or American Association of Cancer Research meeting in 2019, that I mentioned a few moments ago, we think regocertum has the potential to not only target the KRAS mutations in these patients, but also to enhance the efficacy of the checkpoint inhibition of the combination by promoting the infiltration of cancer-fighting immune cells into the tumor and thereby increasing the potential efficacy of the immuno-oncology agents prescribed. We are very encouraged by the progress of this study. I am pleased to say the study has reached the highest dose of regocertum per the current protocol in combination with full-dose nivolumab. Depending on dose-limiting toxicities seen, the lead investigator is considering whether to amend the protocol to further dose-escalate oral regocertin. We expect further updates on this study in the second quarter of 2021. The study objectives are to identify the recommended phase two dose of this novel doublet and to characterize its safety profile. Secondary objectives include the preliminary evaluation of efficacy via assessments of the overall response rate, progression-free survival, and overall survival. preliminary clinical efficacy and scientific correlates such as the genotype of the various possible KRAS mutations and the immune status of the tumors are also being studied. We plan to update you further as the study matures. Looking ahead, We believe the novel combination of regocertib and checkpoint inhibitors is a potentially meaningful option to pursue in lung cancer and other disorders with KRAS mutations managed with immuno-oncology therapies. It is our hope that this program will offer patients who have progressed following first-line therapy with a potential efficacious second-line approach. Advanced malignant melanoma is one such indication we are interested in pursuing. Another investigator-initiated study in this indication is under review based on the AACI data mentioned earlier demonstrating regocertib's effects on the immune system and its ability to promote tumor infiltration with lymphocytes. This study would potentially evaluate regocertib in combination with pembrolizumab, one commonly known as Keytruda, another checkpoint inhibitor that could benefit from the infiltration of anti-cancer immune cells into the tumor. We look forward to updating you further when this study opens later this year. Now one point I want to emphasize is that while we are very interested in the outcomes of ongoing and potential investigator-initiated studies, we intend to preserve our primary focus and resources on our lead compound, ON123300. Finally, with regards to our previously announced COVID-19 work, we are still awaiting word on our funding request to the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority for potential clinical trials with RegoCertib. In the interim, additional preclinical work is ongoing and is being awaited. And now, I'll turn the call over to Mark Gurin for a discussion of our Q1 results. Mark?
spk01: Thanks, Steve, and good afternoon, everyone. I'll begin with a quick review of our first quarter expenses, and then I'll discuss our cash position and cash runway. Okay. Research and development expenses for the first quarter of 2021 were $1.9 million, which compares with $3.4 million for the first quarter of 2020. The decrease was primarily related to lower expenses for the Orvig Assertive Combination Program and the recently completed Phase III INSPIRE study in the 2021 period. General and administrative expenses for the first quarter of 2021 were $2.2 million, which compares with $1.8 million for the first quarter of 2020. The increase was primarily related to higher special stockholder meeting expenses and insurance costs in the 2021 period. We reported a net loss for the first quarter of 2021 of 4.7 million, or two cents per share, on 219.2 million weighted average common shares outstanding. This compares with the net loss for the first quarter of 2020 of 5.1 million, or three cents per share, on 160.3 million weighted average common shares outstanding. During the first quarter, the company strengthened its balance sheet with net proceeds of $35.2 million from two equity offerings. Our cash and cash equivalents as of March 31, 2021, were $48 million versus $19 million as of December 31, 2020. We believe that this cash position will be sufficient to fund our ongoing clinical trials and business operations for more than 18 months and through the achievement of significant milestones, including pursuing corporate development opportunities. This completes my financial review. I'll now turn the call back to Steve.
spk03: Mark, thank you. In summary, we have several key near-term milestones and value drivers ahead of us. One, begin dosing patients in the second quarter of 2021 in the U.S. Phase I trial of ON123300 and advanced cancers, including metastatic breast cancer patients who are refractory to approved CDK4-6 inhibitors. Two, enrollment in the next cohort of the phase one trial of ON123300 in China. Three, our pipeline of investigative sponsored studies with regocertib is advancing, including establishing a dose for further study of the combination of oral regocertib and Abdevo in KRAS-mutated non-small cell lung cancer and other RAS-driven solid tumors, possibly by the end of the year, depending on the need for a potential protocol amendment mentioned earlier. Four, and finally, we continue to actively evaluate strategic licensing opportunities to enhance our product portfolio. As with all of our decisions, any decisions on this front will be driven by science and the potential for clinical benefit in an indication with an unmet medical need. So with that review of our clinical progress and our financial results, we'd like to open the call for questions. And thank you. Operator?
spk05: Ladies and gentlemen, if you wish to register for a question for today's question and answer session, you will need to press star then the number one on your telephone. Your question has been answered and you wish to withdraw your questions. may do so by pressing the pound key. If you're using the speakerphone, please pick up your handset before entering your request. One moment, please, for the first question. And you have a question from Dr. Jo Panginas from HC Wainwright.
spk04: Hi, this is Sarah Nick on for Jo. Thanks for taking the question. I actually have two questions. You mentioned you recently started a rego-certified study in the patients with recessive dystrophic epidermolysis bullosa. I was wondering if you could go a little bit more into the endpoints, especially when the landscape for treating the underlying disease is likely dramatically changing soon with gene therapy, but specifically the chronic wounds in these patients are so inflamed usually. How does something like this impact the assessment of STC responses?
spk03: Well, thank you for that, Sarah. You've already answered your own question in a way. It sounds like you know a lot about this very rare condition, this very rather tragic condition. These patients have terrible blistering of their skin. They denude their skin. They have a tremendous inflammatory component. Their skin gets infected. There's nothing that is efficacious for these patients. So the endpoint will basically be observation of their skin and observation of the blistering that involves their skin, the inflammatory component that is elicited by that blistering, and to see if rigor assertive can impact on the skin condition. Many of the patients concomitantly also have developed, as a result of their underlying epidermolysis bullosa, squamous cell carcinoma. So if they have squamous cell carcinoma and the patients eligible for the trial all do, then it's typically for a cancer trial, the sites of the squamous cell carcinoma will be measured and to see if control is achieved for these patients given either IV or oral regocertum, and that choice is made based on clinical parameters that I discussed.
spk04: Okay, thank you. And my second question, you touched on this a bit. With the lung study having reached its highest dose in the protocol, can you go a bit more into what the communication strategy is from the investigator around the study?
spk03: Yes, so we are in frequent communication with the investigator. We anticipate soon. to do an interim analysis looking at efficacy in the patients treated so far. Because at the highest dose, a sufficient number of DLTs has not been observed, the investigator will have the option with our approval by Ancanova to continue to dose escalate oral regocertum until a sufficient number of DLTs are observed, because in combination with full-dose nivolumab, we want to be confident that we have the best dose of oral regoacertib in combination with nivolumab, so a phase two trial in this indication potentially can be conducted. So that decision will be made after an interim analysis is looked at, and if any additional DLTs are seen. If not, the option to continue to dose escalate. Okay, thank you. You're welcome, Sarah.
spk05: And I'm showing no further questions in the queue. At this time, I'd like to turn the call back to the speakers for any closing remarks. So thank you again.
spk03: to all of you for participating on today's update call. As we've discussed, Ankenova has several near-term milestones and value drivers right ahead of us. We look forward to executing on our business plan and keeping you apprised of our progress. We appreciate your continued interest in our programs and for your support. Thanks again. And have a nice evening. Take care.
spk05: Ladies and gentlemen, thank you for your participation on today's conference call. This concludes today's event. You may now disconnect.
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