Ladies and gentlemen, thank you for standing by. Welcome to the Onconova Therapeutics Second Quarter 2022 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. As a reminder, this call is being recorded today, August 11, 2022. At this time, I'd like to turn the call over to Bruce Mackle of LifeSci Advisors, please go ahead.

Thank you, operator, and welcome everyone to Onconova’s second quarter 2022 financial results and business update conference call. Earlier this afternoon Onconova issued a press release reporting its financial results and business progress. If you have not yet seen this press release it is available in the Investors and Media section of the company's website at www.onconova.com. Following my introduction Onconova’s President and CEO, Dr. Steve Fruchtman will provide an overview of the company's recent highlights and future outlook, followed by Chief Medical Officer, Dr. Mark Gelder, who will discuss progress across Onconova’s pipeline. And lastly, Chief Operating Officer and Chief Financial Officer, Mark Guerin will report the company's second quarter financial results. These prepared remarks will then be followed by a question-and-answer session. Before turning the call over to Onconova’s management team, I'd like to remind everyone that statements made during this conference call 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 Onconova 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 turn the call over to Steve.

Thank you, Bruce, and good afternoon to all our listeners today. This past quarter was an important period of execution for Onconova as we saw progress across our development pipeline. As we advance through the second half of the year, we remained focused internally on the advancement of our lead narazaciclib development program, which as a reminder, consists of two phase 1 alchemer solid tumor studies, designed primarily to evaluate the safety and tolerability of our orally available multi targeted kinase inhibitor. The two administration schemes being tested in these trials mirror those of currently approved CDK 4/6 inhibitors and we'll identify the best recommended phase 2 dose and schedule of administration of narazaciclib going forward. We have completed four dosing cohorts in both phase 1 studies, and the safety data continues to look very favorable to date, nurturing our robust preclinical data set. Key components of this preclinical data set were featured in an abstract recently published at the American Society of Clinical Oncology Annual Meeting. These data, which Dr. Mark Gelder will discuss in greater detail showing narazaciclib potently inhibits CDK 4/6 and other kinases implicated in tumor growth, cancer cell survival and metastasis, as well as the immunomodulatory activities. We believe this inhibitory profile may confer narazaciclib safety and efficacy advantages over currently available agents highlighting is best in class potential. As you are aware, the CDK inhibitors are multibillion dollar franchises to address the need for patients with hormone receptor positive and two negative metastatic breast cancer. Looking forward for narazaciclib, we expect the continued advancement of its phase 1 trials to allow for the second selection of a recommended phase 2 dose, which we anticipate having before the end of this year. We continue to hone in on the indications and treatment regimens. We will…

Thank you, Steve. And welcome again to everyone who has joined us this afternoon. As usual, I'll begin my portion of the earnings call by reviewing the status of our lead narazaciclib program, and its two complimentary phase 1 dose escalation study. These include a US trial, evaluating a continuous daily dosing schedule, and the trial in China, evaluating three weeks on one week off dosing schedule. Both studies are enrolling patients with advanced solid tumors. I am pleased to report this since our last earnings call, the US study has advanced from the fourth to the fifth dose escalation cohort, which is evaluating a 200-milligram oral dose of narazaciclib administered each day. We have not observed any dose limiting toxicities, or clinically meaningful cases of neutropenia in the trial to date and continue to see anticipated on target effects of the study drug. We've remained highly encouraged by these data as a dose limiting factor and therefore tolerability issue of both ribociclib and palbociclib. The most widely prescribed CDK4/6 inhibitors is the bone marrow toxicity or myelosuppression associated with these edges. This necessitates an interrupted dosing schedule with drugs given three out of every four weeks, so that the bone marrow can recover. If data from our US phase 1 study continues to mature favorbly, we would likely seek to move forward with a continuous daily dosing regimen for narazaciclib. This would clearly differentiate our therapeutic candidate and could potentially contribute to an improved efficacy profile as the one week off require for both palbociclib and ribociclib may permit tumor cell proliferation and therefore tumor growth. To better inform our development we recently enacted a protocol of men in the US trial that will allow us to assess narazaciclib biological activity in all cohorts moving forward. We will do…

Thank you, Mark. It's my pleasure to be speaking on the call today. I'm happy to report that Onconova maintain its strong financial position over the last quarter with cash and cash equivalents of $46.5 million as of June 30, 2022. This compares to $55.1 million as of December 31, 2021. Based on our current projections, we believe our current cash position will be sufficient to fund our ongoing clinical trials and business operations, including the pursuit of corporate development opportunities for more than 18 months. This runway is expected to enable the completion of key value trading milestones across our pipeline. Our research and development expenses for the second quarter of 2022 were $2 million, compared to $1.9 million for the second quarter of 2021. General and Administrative expenses for the second quarter of 2022 were $2.1 million, compared with $2.9 million for the second quarter of 2021. We reported a net loss for the second quarter of 2022 of $4 million or $0.19 per share on $20.9 million weighted average shares outstanding. This compares with the net loss for the second quarter of 2021 of $4.2 million or $0.27 per share on $15.8 million weighted average shares outstanding. With my financial view complete, I will now hand the call off to Steve to summarize our anticipated milestone before transitioning to question-and-answer.

Thank you, Mark. Before running through our upcoming milestones, I'd like to congratulate both Mark and our Head of Corporate Development, Dr. Adar Makovski-Silverstein on their recent and very well-deserved promotions. They each have transition into their expanded roles seamlessly. And I look forward to our continued working together. Turning now to anticipated milestones, we expect to identifying the Rigosertib optimal phase 2 dose the second half of the year. This will inform the design of subsequent studies, including a phase 2 basket trial in multiple indications and doubles. With regards to Rigosertib, we plan to announce additional data in the phase 1/2 KRAS mutated my small cell lung cancer trial via an abstract submitted to the upcoming ESMO meeting in September. Alongside our interactive narazaciclib Rigosertib programs, we continue to evaluate visits develop opportunities that could potentially expand our pipeline. Our guiding principles in this area have not changed. As we are making assessments based on scientific merit, and the size of the unmet need each potential candidate seeks to address. Many companies we interact with are having problems in the current financial climate, to have adequate resources to develop their own new molecular entities. Based on the financial assessment Mark shared with you, we are confident we have the required financial resources to continue our important work to develop efficacious and safe drugs for patients in need. With that I’d like to conclude the formal portion of today's call, by thanking all those who played a role in the progress we have discussed today. This includes Onconova’s employees, collaborators, investigators, and most important of all the brave clinical trial patients. I'll now open the call for questions. Operator?

One moment please for our first question. And we'll take our first question from the line of Charles Zhu was Guggenheim Securities. Please go ahead. Your line is now open.

Hey, good afternoon, everyone. And thanks for taking my questions have given us sounds like you're on track to identify a potential recommended phase 2 dose for narazaciclib as early as the end of this year, and also looks like you're enrolling dose cohort five for both of the phase 1 study should we interpret that as potentially dose cohorts six to seven as being likely maximum tolerated doses. Thanks.

Mark, would you like to answer that, thank you.

So thank you, Steve. And , as I said so far to date through cohort four, we have not seen any dose limiting toxicity through DLT. We are beginning to see some anticipated expected on target activities. We have incorporated the DiviTum assay into the into the phase 1 study so that we have a good PD-1 mark. With all of that said, I have no idea at what point we might reach our quote unquote dose limiting toxicity or MTD, maximal tolerated dose. What I do know is that of we will continue to dose escalate until we do reach the maximum tolerated dose or a dose at which, based on the PD-1 marker, we have clear evidence of maximal biological effect whether that's this dose cohort, i.e., the fifth, whether that's the sixth or the seventh, I have no way of predicting, but based on the quote unquote, on target activity, we are beginning to see. I think that we probably are getting reasonably close. But what exactly that will be what those said exactly will be and exactly when we'll get there, I can't say I am very hopeful it's before the end of the year, because we have some other studies that we would like to start moving forward.

Yes. Great, thanks for taking that…

Thank you, Mark.

Our next question from the line of Chun Lung with Ladenburg Thalmann. Please go ahead, your line is now open.

Hello, thank you for taking my question. And this is Lung Chun on for Ahu Demir. My question is just Mark talk about a future of phase 2 basket trial. If possible, could you please give us more color on the communist plan on or other stock clip and you plan to combine with other drugs and other education besides breast cancer or any specific marker to use? Thanks

Mark?

So, all I can say for certain at this point is that we are putting together a panel a slate of stuff studies that we are very interested in moving forward with the some of them are single agent narazaciclib, others are narazaciclib in combination with other anti-cancer therapies. What I can say is that in the breast cancer space, if you look at the three approved CDK 4/6 inhibitors most all of their approvals are in combination with an anti- estrogen whether that's an aromatase inhibitors such as Letrozole or Palbociclib, etcetera. As we've said, we are clearly going to move forward in the CDK 4/6 refractory hormone receptor positive HER2 negative metastatic breast cancer space, that will likely be in combination with an anti-estrogen. The exact final decisions on the design of that trial have not yet been made. But we're 99.9% of the way there. We have a trial designed in mantle cell lymphoma, as we've talked about, again, that has not been absolutely finalized. So I don't want to say much more about that. And, we're looking at some other trials. So until we get absolutely final, cemented in written in stone trial designs with various combinations. I hate to say anything about it publicly. But that's really all I can say. Steve, you may or may not say anything more.

Well, thank you, Mark. I think you're comprehensive are clearly that these drugs are approved in metastatic breast cancer. As Mark mentioned, eventually, all patients who will come refractory based on a mechanism of action presented at ASCO we believe we have and we have shown you evidence as well cancer cell breast cancer that we are active in situations with palbociclib is not to clearly refractory breast cancer population is a major interest. We also have data in mantle cell suggestive data in myeloma pre clinically. So we have a number of indications we can study. As Mark mentioned some of the combinations with an anti-estrogens clearly, some of the indications additional may include checkpoint inhibitors, BTK inhibitors and thinking about mantle cell. So we have a number of possible studies, we believe that as a psychic, to bring benefit to patients, I need to show that in the phase 2 bucket trials and plan to initiate as soon as we know the recommended phase 2 does.

That's great. Thank you so much.

Thank you.

We'll take our next question from the line of Robert LeBoyer with Nobel Capital Markets, please go ahead. Your line is now open.

Good afternoon. I just want a little clarification on something that that you touched on a little earlier. And with the mesocycle of trial, I understand that you're the cohorts thus far are looking very good with no dose limiting toxicity, and you're enrolling more cohorts? Is there any timeframe? You kind of touched on the idea of year end? But in terms of the next cohorts do you have any expectation of you have more guidance on when phase 2 would start?

So I'll take that to give Mark Gelder. And we can't predict when phase 2 will start until we know the recommended phase 2 dose reason, we're suggesting we may know the recommended phase 2 just before the end of the year, even though we're not seeing as above highlighted the US study. And he does seven toxicities, we are beginning to see engagement of our targets. As you know the CDK 4/6 inhibitors targets the push rapidly proliferating cell population in our body and that's the bone marrow. We are seeing some decrease in the white gap and the patients treated in the current cohort with narazaciclib that anything that approaches a serious adverse event. Since we are engaging the target in the marrow, we know we have an active drug the whitecaps have gotten to know up. And as we continue to dose escalate, we may see more of that. But it is hard to predict exactly when the white couch or some other toxicity will be observed severe enough to call that we have reached the dose limiting toxicity need to pull back. But pharmacodynamic marker and as Mark describe in depth also help us to determine the optimal phase 2 dose. So it is hard to forget, we did try to give some guidance where we suspect perhaps by the end of this year, we will be able to know the recommended phase 2 dose. And once we do that, we will rapidly move on to what we really want to do, which is open the bucket trials for the various indications that we described.

Okay, great. Thank you very much.

Thank you, Robert.

There are showing no further questions in the queue. At this time, I'd like to turn the conference back to the speakers for any closing remarks.

Thank you, operator, and thanks again to all for listening and for your insightful questions. We have enjoyed updating you on our recent progress. We continue to look forward to making even more progress. And we wish everyone a very lovely evening and thank you again.

Ladies and gentlemen, thank you for your participation on today's conference call. This concludes today's event. You may now disconnect.