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spk00: Ladies and gentlemen, this is the operator. Today's conference is scheduled to begin momentarily. Until that time, your lines will be placed on hold. Thank you for your patience. Thank you. Ladies and gentlemen, thank you for standing by Welcome to the Onconova Therapeutics 2020 Financial Results and Business Update Conference Call. At this time, all participants are in a 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 1 on your touch-tone phone. If anyone has difficulty hearing the conference, please press star 0 for operator assistance. As a reminder, this call is being recorded today, March 11, 2021. At this time, I would like to turn the call over to Avi Oller, Senior Vice President of Corporate Development and General Counsel. Sorry, the floor is yours.
spk13: Thank you, operator. Good afternoon, everyone, and welcome to Akanova's 2020 Financial Results and Business Update conference call. Earlier this afternoon, we issued a press release reporting our 2020 financial results and business progress. If you have not seen this press release, It is available in the investors and media section of our website at www.oconova.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 our 2020 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 Casenza, our lead scientists. 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. Please see the forward-looking statements disclaimer in the press release issued this afternoon and the risk factors in the company's current and future filings with the SEC. With that, it is now my pleasure to turn the call over to Steve.
spk06: Thank you, Avi. Good afternoon, everyone, and thank you for joining us. We continue to hope you, your colleagues, and your loved ones are safe and healthy. We are living in amazing times, witnessing the power of nature and the dramatic influence key scientific discoveries can have to help humankind. A truly extraordinary year. Before I discuss the progress to enter the clinic, we are making in advancing our multi-kinase inhibitor, ON123-300, which I will refer to as ON123. I want to thank our stockholders for your tremendous support of Ankenover over the years. I also want to ask our stockholders of record as of January 12th that have not yet voted to vote today in Ankenova's stockholders meeting. The board of directors firmly believes that the stockholder proposals to change our capital structure by a reverse stock split are in the best interest of stockholders. Turning out the vote is imperative for the company to execute its strategic plan from a strengthened position. We believe the approval of these proposals will, one, ensure that we maintain our NASDAQ listing. Two, a higher stock price will increase the company's appeal and permit institutional and fundamental biotech investors to invest in Ankenova. And three, support in-licensing programs under evaluation. We believe approval of the proposals is needed to continue to progress new and existing programs and create long-term value for stockholders. We urge all stockholders who have not yet voted to please vote today. At the March 4th special meeting, which was adjourned to April 1st, more than 70% of the shares which had voted, voted in favor of two proposals. One, for a reverse stock split, and two, for a decrease in the number of our authorized shares. However, we did not meet the required threshold for approval of more than 50% of the outstanding shares for the two proposals. In addition to the support of our stockholders who voted, all three independent proxy advisory firms, ISS, Glass Lewis, and Egan Jones, have recommended stockholders vote for the proposals. Their support is based on their view that a yes vote is in the best interest of stockholders. The stockholder meeting process is also costly to the company and to you. If any stockholders of record have not voted, we urge you to please do so today to avoid the need for additional meetings. If you voted against the proposals, please reconsider your vote. Reach out to speak with any member of management or our proxy solicitor, McKenzie Partners, if you have any questions regarding the proposals. or email us at letter I, letter R, at Ankenover.us. We announced that we will make a $50,000 donation to the American Cancer Society if we can achieve 70% or more voting participation by stockholders of record on January 12th. regardless of how these stockholders vote. As our focus is on studying cancer indications with our novel compounds, we believe that supporting the important work of the American Cancer Society to thank our shareholders for voting is worthwhile and fitting. Again, we thank you for your consideration and please vote your shares today. Let me now turn to a review of our business and clinical progress, starting with our lead product, ON123. The fourth quarter of 2020 and recent weeks have been very active and productive as we continue preparations to advance ON123 into the clinic in the United States. We submitted an investigational new drug application to the FDA for a phase one study in advanced cancers, including hormone receptor positive HER2 negative metastatic breast cancer patients refractory or resistant to health authority approved CDK4-6 inhibitors. In December of 2020, we received clearance from the FDA to begin the phase one study and have since received institutional review board or IRB approval at our first site. We expect that the first patient will be enrolled in the study sometime during the second quarter of this year. Two additional sites are in the study setup process. With three phase one sites, we expect we will be able to expedite the timeline to the important milestone of establishing the recommended phase two dose. We anticipate three phase one sites in the U.S. in conjunction with the phase one trial being conducted with ON123 in China, will establish the recommended phase two optimal dose to study specific cancer indications that overexpress the tyrosine kinase targeted by ON123. In addition, 2CDK, 4, and 6. These phase 1 studies will assess the safety, tolerability, and pharmacokinetics of ON123 administered orally at increasing doses starting at 40 milligrams daily continuously for 28 days in the U.S. study or three out of four weeks in the study in China. These two different administration schemes mimic the different administration schemes used for the three FDA-approved CDK4 and 6 inhibitors. And we believe we'll support finding the optimal recommended phase 2 dose of ON123. The phase one study of ON123 in China has enrolled three patients, each with metastatic breast cancer, and enrollment in the second dose cohort of 80 milligrams has begun. We are pleased to report that ON123 appears to be well tolerated thus far, as no dose-limiting toxicities have been seen to date. We are most interested in studying patients with refractory hormone receptor positive HER2 negative breast cancer since this indication is the one for which the established commercial 4-6 inhibitors are approved. We believe evidence of efficacy in metastatic breast cancer along with an acceptable safety profile could be our most rapid path for an approval and for the possibility to ultimately enter the first line setting in this indication. Perhaps as a single agent which would minimize issues with tolerance when the estrogen pathway is interfered with, as is required for the commercially approved CDK4 and 6 inhibitors when prescribed. Due to the broader kinase inhibitory spectrum of ON123, it has the potential for efficacy in additional tumor indications as well. We will share with you our developmental plans following the completion of the Phase I studies and our interactions with the FDA. To remind you, ON123 is a proprietary first-in-class multi-kinase inhibitor, which distinguishes itself by targeting CDK4-6 and additional tyrosine kinase pathways involved in the proliferation of cancer cells and the metastatic potential of cancers as well. We believe with this mechanism of action targeting CDK4-6 and additional kinases such as FLT3 and others, OIN123 represents an innovative approach to treating solid tumors and hematological malignancies that are refractory or have become resistant to CDK4-6 inhibitors, as well as tumor indications where this class of drugs to date do not have regulatory approval. Based on preclinical models, ON123 may have utility for broader breast cancer indications, such as triple negative breast cancer, as well as additional tumor types. We're very excited about the potential to improve patient cancer care with ON123. Our other pipeline compounds Rigocertib targets pathways involved in neoplasia that causes it to be cytotoxic to multiple tumor types in vitro. The first description of its unique mechanism of action was described in the prestigious journal Cell in 2016, suggesting Rigocertib interfered with the mutated RAS pathway. Subsequent published studies demonstrated that Rigocertib may function as a microtubulin inhibitor as well as influencing the JNK pathway and thereby suppression of RAS signaling.
spk05: We are supporting ongoing
spk06: Investigator-sponsored studies with the oral formulation of regocertib and are preparing to support several new studies exploring the use of oral regocertib for cancers driven by mutations of the RAS gene. Currently, a Phase I study in patients with advanced KRAS mutated non-small cell lung cancer is being conducted with regocertum in combination with the PD-1 inhibitor nivolumab, a drug provided for this study by Bristol Myers Scribd. The study is open and continuing to enroll. The study objectives are to identify the recommended phase two dose of this novel doublet and to characterize its safety profile. The KRAS mutation is a predominant genetic driver of non-small cell lung cancer. Given their utility in multiple cancer settings, checkpoint inhibitors are among the world's top selling pharmaceutical products and they continue to gain FDA approvals for new indications. In our view, this makes our novel combination approach with migroserta a potentially meaningful option to pursuing lung cancer and other disorders with KRAS mutations managed with immuno-oncology therapies. We hope These studies will offer patients who have progressed on first-line therapy with a potential efficacious second-line treatment. Results from the Phase I non-small-cell lung cancer study are expected in 2021. In addition, an investigator-initiated Phase Ib-II study with oral regocertum monotherapy in advanced RAS-mutated squamous cell carcinoma is now open. And another study based on data presented at the American Association of Cancer Research meeting in 2019 is under review in metastatic malignant melanoma, potentially in combination with chytruda. A preclinical study is also evaluating oral regocertib in clear cell renal cancer. Other than the cost of supplying oral regocertib to the investigators, Ankenova does not expect to incur significant expenses for these investigator-initiated studies. We are still awaiting word on our funding requests to the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority, also known as BARDA, for the possible funding of clinical trials with RegoCertib in patients with COVID-19 disease. In the interim, Additional preclinical work is ongoing. And now I'll turn the call over to Mark for a discussion of our 2020 financial results.
spk11: Mark? Thanks, Steve, and good afternoon, everyone. I'll start with a review of our 2020 expenses, and then I'll discuss our cash position and cash runway. Okay. Research and development expenses for 2020 were $16.9 million, and this compares with $15.5 million for 2019. The increase was primarily related to higher regulatory consulting expenses and manufacturing costs related to the clinical supply of ON123, partially offset by lower expenses for the oral-rig assertive combination program and the Phase III INSPIRE study in the 2020 period. General and administrative expenses for 2020 were $8.3 million, consistent with 2019. Lower personnel and stock compensation expenses in 2020 due to personnel reductions in the 2019 period were offset by higher pre-commercialization, insurance, and corporate legal and stockholder meeting expenses in the 2020 period. Net loss for 2020 was $25.2 million, or $0.14 per share, on 174 million weighted average shares outstanding. And this compares with a loss of $21.5 million, or $1.49 per share, for 2019 on 14.4 million weighted shares outstanding. Cash and cash equivalents as of December 31, 2020, were $19 million, compared with $22.7 million as of December 31, 2019. After the end of the year, we raised net proceeds of $35.2 million from two equity offerings with institutional investors. Since September 30, 2020, approximately 3.7 million warrants have been exercised, resulting in proceeds of $0.7 million. As a result, our cash and cash equivalents on February 28, 2021, were approximately $49.5 million. We believe that this CAS position will be sufficient to fund our ongoing 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.
spk06: Thank you, Mark. We are very excited about our development plans for ON123 and all legal certain and believe we have a very strong financial position. We urge our stockholders who have not voted to please vote today in anticipation of the special meeting. We'd now like to open the call for questions. Operator?
spk00: Thank you, Steve. 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. If your question has been answered and you wish to withdraw your request, you may do so by pressing the pound key. If you are using a speakerphone, please pick up your handset before entering your request. One moment, please, for the first question. Our question comes from the line of Joe Pangenis. Sir, please go ahead. Your line is open.
spk15: Great. Good afternoon. This is Matt Keller on for Joe Pangenis. Thanks for taking a couple of our questions. First, can you remind us of your cell line resistance studies using ON123 and the benefits that you saw?
spk06: Sure. And thank you for that. Steve, Dr. Cozenza, who's on the phone, did most of those studies. Steve, would you like to take the question?
spk14: Sure. Thank you for that question. This is Steve Cosenza. I believe you are referring to the resistant cell lines that are resistant to pablocycline. And these cell lines were resistant due to a deficiency in the RB pathway, either by being null, meaning they're not expressing RB, or they are mutated in that pathway. And therefore, these pathways are not required for cell division. The main target of the approved CDK4-6 inhibitors, such as pabliciclib and ribociclib, and to some extent abibiciclib, require a functional RV pathway for these compounds to be active in these tumor cells. Our compounds, since it's a multi-kinase inhibitor, were found to, these cells were found to be similarly sensitive to these, to ON123, 1, 2, 3, 300, as are the proficient cells.
spk15: Great. Thank you. That's much appreciated. Second question for you guys. I know you kind of mentioned this in the presentation, but can you provide any more detail on when you might think that we could see some of the long data with the GeoInstitute this year?
spk06: So, again, thank you for that question. You're asking about the combination lung cancer trial, KRAS-mutated lung cancer trial in advanced KRAS-mutated patients. So the dose of regocertib has already reached the highest level of regocertib that we've given in the current scheme in combination with full-dose nivolumab. we will determine based on whether or not those limiting toxicities are observed. If we've already established the recommended phase two dose of the doublet, if we have not seen additional dose limiting toxicities, we may elect to continue to dose escalate regocertib. In either scenario, we anticipate having the recommended phase two dose of the doublet before the end of the year.
spk15: Great. Fantastic. Also very helpful. One more question before I let you guys go, also related to timelines. When do you think you can see some data from the squamous cell carcinoma data that's associated with RDEB patients?
spk06: Again, thank you for your question. That's a more difficult question to answer. So these are very rare squamous cell cancers because they are driven by genomic abnormalities of RAS. So these patients are few and far between. It is an international study in both Europe and the US, but it's very hard and rare indications to determine when we will have the clinical data. So I'm going to basically answer, I do not know. It's going to be dependent on how often, how frequent these patients can be identified. But we are working with centers that have great expertise in this very rare RAS-driven squamous cell carcinoma of the skin.
spk15: Yep, totally makes sense. Thank you again for providing that input, and thanks again for taking my question. Congratulations.
spk00: I'm showing no further questions in the queue at this time. I'd like to turn the call back to Mr. Steve Frackman for any closing remarks.
spk06: Well, thank you all for participating on today's update call. To reiterate, we have several near-term milestones and value drivers ahead of us. The first, We plan to commence patient enrollment in the second quarter of 2021 for a U.S. Phase I trial with ON123 and advanced cancers, including metastatic breast cancer patients refractory to approved CDK4-6 inhibitors. We expect to have the recommended Phase II dose for ON123 by the first half of 2022. Two, the pipeline of investigative-sponsored studies with oral regocertib is advancing, and further progress is anticipated in 2021, including establishing a dose for further study of the combination of oral regocertum and nivolumab in KRAS-mutated non-small cell lung cancer and other solid tumor RAS-driven cancers by the end of the year. Three, we are actively evaluating strategic opportunities to enhance our product portfolio driven by science and the potential for clinical benefit for patience, hopefully before the end of the year. Four, and again, as an important reminder, please take action today and vote for the proposals in the special meeting of stockholders. We greatly appreciate your continued interest in the programs of Ankenova. Should you have any additional questions, please feel free to contact us. Thank you. Again, stay safe and have a nice evening.
spk00: Ladies and gentlemen, thank you for your participation in today's conference call. This concludes today's event. You may now disconnect.
spk18: Thank you. Thank you. Thank you. Thank you. you Bye. Thank you.
spk19: Bye. you
spk00: Ladies and gentlemen, thank you for standing by. Welcome to the Onconova Therapeutics 2020 Financial Results and Business Update conference call. At this time, all participants are in a 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 one on your touch-tone phone. If anyone has difficulty hearing the conference, please press star zero for operator assistance. As a reminder, this call is being recorded today March 11th, 2021. At this time, I would like to turn the call over to Avi Oller, Senior Vice President of Corporate Development and General Counsel. Sorry, the floor is yours.
spk13: Thank you, operator. Good afternoon, everyone, and welcome to Akanova's 2020 Financial Results and Business Update Conference Call. Earlier this afternoon, we issued a press release reporting our 2020 financial results and business progress. If you have not seen this press release, It is available in the investors and media section of our website at www.oconova.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 our 2020 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 Casenza, our lead scientists. 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 involved 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. Please see the forward-looking statements disclaimer in the press release issued this afternoon and the risk factors in the company's current and future filings with the SEC. With that, it is now my pleasure to turn the call over to Steve.
spk06: Thank you, Avi. Good afternoon, everyone, and thank you for joining us. We continue to hope you, your colleagues, and your loved ones are safe and healthy. We are living in amazing times, witnessing the power of nature and the dramatic influence key scientific discoveries can have to help humankind. A truly extraordinary year. Before I discuss the progress to enter the clinic, we are making in advancing our multi-kinase inhibitor, ON123-300, which I will refer to as ON123. I want to thank our stockholders for your tremendous support of Onconover over the years. I also want to ask our stockholders of record as of January 12th that have not yet voted to vote today in Ankenova's stockholders meeting. The board of directors firmly believes that the stockholder proposals to change our capital structure by a reverse stock split are in the best interest of stockholders. Turning out the vote is imperative for the company to execute its strategic plan from a strengthened position. We believe the approval of these proposals will, one, ensure that we maintain our NASDAQ listing. Two, a higher stock price will increase the company's appeal and permit institutional and fundamental biotech investors to invest in Ancanova. And three, support in-licensing programs under evaluation. We believe approval of the proposals is needed to continue to progress new and existing programs and create long-term value for stockholders. We urge all stockholders who have not yet voted to please vote today. At the March 4th special meeting, which was adjourned to April 1st, more than 70% of the shares which had voted, voted in favor of two proposals. One, for a reverse stock split, and two, for a decrease in the number of our authorized shares. However, we did not meet the required threshold for approval of more than 50% of the outstanding shares for the two proposals. In addition to the support of our stockholders who voted, all three independent proxy advisory firms, ISS, Glass Lewis, and Egan Jones, have recommended stockholders vote for the proposals. Their support is based on their view that a yes vote is in the best interest of stockholders. The stockholder meeting process is also costly to the company and to you. If any stockholders of record have not voted, we urge you to please do so today to avoid the need for additional meetings. If you voted against the proposals, please reconsider your vote. Reach out to speak with any member of management or our proxy solicitor, McKenzie Partners, if you have any questions regarding the proposals. or email us at letter I, letter R, at Ankenover.us. We announced that we will make a $50,000 donation to the American Cancer Society if we can achieve 70% or more voting participation by stockholders of record on January 12th. regardless of how these stockholders vote. As our focus is on studying cancer indications with our novel compounds, we believe that supporting the important work of the American Cancer Society to thank our shareholders for voting is worthwhile and fitting. Again, we thank you for your consideration And please vote your shares today. Let me now turn to a review of our business and clinical progress, starting with our lead product, OAN123. The fourth quarter of 2020 and recent weeks have been very active and productive as we continue preparations to advance ON123 into the clinic in the United States. We submitted an investigational new drug application to the FDA for a phase one study in advanced cancers, including hormone receptor positive, HER2 negative, metastatic breast cancer patients, refractory or resistance, through Health Authority-approved CDK4-6 inhibitors. In December of 2020, we received clearance from the FDA to begin the Phase I study and have since received Institutional Review Board, or IRB, approval at our first site. We expect that the first patient will be enrolled in the study sometime during the second quarter of this year. Two additional sites are in the study setup process. With three phase one sites, we expect we will be able to expedite the timeline to the important milestone of establishing the recommended phase two dose. We anticipate three Phase I sites in the U.S. in conjunction with the Phase I trial being conducted with ON123 in China will establish the recommended Phase II optimal dose to study specific cancer indications that overexpress the tyrosine kinase targeted by ON123 in addition to CDK4 and 6. These phase one studies will assess the safety, tolerability, and pharmacokinetics of ON123 administered orally at increasing doses starting at 40 milligrams daily continuously for 28 days in the US study, or three out of four weeks in the study in China. These two different administration schemes mimic the different administration schemes used for the three FDA-approved CDK4 and 6 inhibitors. And we believe we'll support finding the optimal recommended phase two dose of ON123. The phase one study of ON123 in China has enrolled three patients, each with metastatic breast cancer. And enrollment in the second dose cohort of 80 milligrams has begun. We are pleased to report that ON123 appears to be well tolerated thus far as no dose limiting toxicities have been seen to date. We are most interested in studying patients with refractory hormone receptor positive HER2 negative breast cancer since this indication is the one for which the established commercial 4-6 inhibitors are approved. We believe evidence of efficacy in metastatic breast cancer, along with an acceptable safety profile, could be our most rapid path for an approval and for the possibility to ultimately enter the first line setting in this indication. perhaps as a single agent, which would minimize issues with tolerance when the estrogen pathway is interfered with, as is required for the commercially approved CDK4 and 6 inhibitors when prescribed. Due to the broader kinase inhibitory spectrum of ON123, it has the potential for efficacy in additional tumor indications as well. We will share with you our developmental plans following the completion of the Phase I studies and our interactions with the FDA. To remind you, ON123 is a proprietary first-in-class multi-kinase inhibitor which distinguishes itself by targeting CDK4-6 and additional tyrosine kinase pathways involved in the proliferation of cancer cells and the metastatic potential of cancers as well. We believe with this mechanism of action targeting CDK4-6 and additional kinases such as FLT3 and others, OIN-123 represents an innovative approach to treating solid tumors and hematological malignancies that are refractory or have become resistant to CDK4-6 inhibitors, as well as tumor indications where this class of drugs to date do not have regulatory approvals. Based on preclinical models, ON123 may have utility for broader breast cancer indications, such as triple negative breast cancer, as well as additional tumor types. We're very excited about the potential to improve patient cancer care with ON123. Our other pipeline compound, RegoCerti, targets pathways involved in neoplasia that causes it to be cytotoxic to multiple tumor types in vitro. The first description of its unique mechanism of action was described in the prestigious journal Cell in 2016. suggesting regocertib interfered with the mutated RAS pathway. Subsequent published studies demonstrated that regocertib may function as a microtubulin inhibitor as well as influencing the junk or JNK pathway and thereby suppression of RAS signaling. We are supporting ongoing investigator-sponsored studies with the oral formulation of regocertib and are preparing to support several new studies exploring the use of oral regocertib for cancers driven by mutations of the RAS gene. Currently, a Phase I study in patients with advanced KRAS mutated non-small cell lung cancer is being conducted with regocertum in combination with the PD-1 inhibitor nivolumab, a drug provided for this study by Bristol Myers Scribd. The study is open and continuing to enroll. The study objectives are to identify the recommended Phase II dose of this novel doublet and to characterize its safety profile. The KRAS mutation is a predominant genetic driver of non-small cell lung cancer. Given their utility in multiple cancer settings, checkpoint inhibitors are among the world's top-selling pharmaceutical products, and they continue to gain FDA approvals for new indications. In our view, this makes our novel combination approach with migroserta a potentially meaningful option to pursuing lung cancer and other disorders with KRAS mutations managed with immuno-oncology therapies. We hope These studies will offer patients who have progressed on first-line therapy with a potential efficacious second-line treatment. Results from the Phase I non-small-cell lung cancer study are expected in 2021. In addition, an investigator-initiated Phase Ib-II study with oral regocertive monotherapy in advanced RAS-mutated squamous cell carcinoma is now open. And another study based on data presented at the American Association of Cancer Research meeting in 2019 is under review in metastatic malignant melanoma, potentially in combination with chytruda. A preclinical study is also evaluating oral regocertib in clear cell renal cancer. Other than the cost of supplying oral regocertib to the investigators, Ankenova does not expect to incur significant expenses for these investigator-initiated studies. We are still awaiting word on our funding requests to the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority, also known as BARDA, for the possible funding of clinical trials with RegoCertib in patients with COVID-19 disease. In the interim, Additional preclinical work is ongoing. And now I'll turn the call over to Mark for a discussion of our 2020 financial results. Mark?
spk11: Thanks, Steve, and good afternoon, everyone. I'll start with a review of our 2020 expenses, and then I'll discuss our cash position and cash runway. Okay. Research and development expenses for 2020 were $16.9 million, and this compares with $15.5 million for 2019. The increase was primarily related to higher regulatory consulting expenses and manufacturing costs related to the clinical supply of ON123, partially offset by lower expenses for the oral-rig assertive combination program and the Phase III INSPIRE study in the 2020 period. General and administrative expenses for 2020 were $8.3 million, consistent with 2019. Lower personnel and stock compensation expenses in 2020 due to personnel reductions in the 2019 period were offset by higher pre-commercialization, insurance, and corporate legal and stockholder meeting expenses in the 2020 period. Net loss for 2020 was $25.2 million, or 14 cents per share, on 174 million weighted average shares outstanding. And this compares with a loss of $21.5 million, or $1.49 per share, for 2019 on 14.4 million weighted shares outstanding. Cash and cash equivalents as of December 31, 2020, were $19 million, compared with $22.7 million as of December 31, 2019. After the end of the year, we raised net proceeds of $35.2 million from two equity offerings with institutional investors. Since September 30, 2020, approximately 3.7 million warrants have been exercised, resulting in proceeds of $0.7 million. As a result, our cash and cash equivalents on February 28, 2021, were approximately $49.5 million. We believe that this cash position will be sufficient to fund our ongoing 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. Thank you, Mark.
spk06: We are very excited about our development plans for ON123 and All Legal Certainty and believe we have a very strong financial position. We urge our stockholders who have not voted to please vote today in anticipation of the special meeting. We'd now like to open the call for questions. Operator?
spk00: Thank you, Steve. 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. If your question has been answered and you wish to withdraw your request, you may do so by pressing the pound key. If you are using a speakerphone, please pick up your handset before entering your request. One moment, please, for the first question. Our question comes from the line of Joe Pangenis. Sir, please go ahead. Your line is open.
spk15: Great. Good afternoon. This is Matt Keller on for Joe Pangenis. Thanks for taking a couple of our questions. First, can you remind us of your cell line resistance studies using ON123 and the benefits that you saw?
spk06: Sure. And thank you for that. Steve, Dr. Cozenza, who's on the phone, did most of those studies. Steve, would you like to take the question?
spk14: Sure. Thank you for that question. This is Steve Cosenza. I believe you are referring to the resistant cell lines that are resistant to pablocycline, and these cell lines were resistant due to a deficiency in the RB pathway, either by being null, meaning they're not expressing RB, or they are mutated in that pathway. these pathways are not required for cell division. The main target of the approved CDK4-6 inhibitors, such as pabliciclib and ribociclib, and to some extent abibiciclib, require a functional RV pathway for these compounds to be active in these tumor cells. Our compounds, since it's a multi-kinase inhibitor, were found to, these cells were found to be similarly sensitive to these, to ON123, 1, 2, 3, 300, as are the proficient cells.
spk15: Great. Thank you. That's much appreciated. Second question for you guys. I know you kind of mentioned this in the presentation, but can you provide any more detail on when you might think that we could see some of the long data with against the TIB this year?
spk06: So, again, thank you for that question. You're asking about the combination lung cancer trial, KRAS-mutated lung cancer trial in advanced KRAS-mutated patients. So the dose of regocertib has already reached the highest level of regocertib that we've given in the current scheme in combination with full-dose nivolumab. we will determine based on whether or not dose-limiting toxicities are observed, if we've already established the recommended phase 2 dose of the doublet, if we have not seen additional dose-limiting toxicities, we may elect to continue to dose-escalate regocertib. In either scenario, we anticipate having the recommended phase two dose of the doublet before the end of the year.
spk15: Great, fantastic, also very helpful. One more question before I let you guys go, also related to timelines. When do you think you can see some data from the squamous cell carcinoma data that's associated with RDEB patients?
spk06: Again, thank you for your question. That's a more difficult question to answer. So these are very rare squamous cell cancers because they are driven by genomic abnormalities of RAS. So these patients are few and far between. It is an international study in both Europe and the US, but it's very hard and rare indications to determine when we will have the clinical data. So I'm going to basically answer, I do not know. It's going to be dependent on how often, how frequent these patients can be identified. But we are working with centers that have great expertise in this very rare RAS-driven squamous cell carcinoma of the skin.
spk15: Yep, totally makes sense. Thank you again for providing that input, and thanks again for taking my question. Congratulations.
spk00: I'm showing no further questions in the queue at this time. I'd like to turn the call back to Mr. Steve Frackman for any closing remarks.
spk06: Well, thank you all for participating on today's update call. To reiterate, we have several near-term milestones and value drivers ahead of us. The first, We plan to commence patient enrollment in the second quarter of 2021 for a U.S. Phase I trial with ON123 and advanced cancers, including metastatic breast cancer patients refractory to approved CDK4-6 inhibitors. We expect to have the recommended Phase II dose for ON123 by the first half of 2022. Two, the pipeline of investigative-sponsored studies with oral regocertib is advancing, and further progress is anticipated in 2021, including establishing a dose for further study of the combination of oral regocertum and nivolumab in KRAS-mutated non-small cell lung cancer and other solid tumor RAS-driven cancers by the end of the year. Three, we are actively evaluating strategic opportunities to enhance our product portfolio driven by science and the potential for clinical benefit for patience, hopefully before the end of the year. Four, and again, as an important reminder, please take action today and vote for the proposals in the special meeting of stockholders. We greatly appreciate your continued interest in the programs of Ankenova. Should you have any additional questions, please feel free to contact us. Thank you. Again, stay safe and have a nice evening.
spk00: Ladies and gentlemen, thank you for your participation in today's conference call. This concludes today's event. You may now disconnect.
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