Onconova Therapeutics Inc. Q1 2023 Earnings Call
Speaker 1: Ladies and gentlemen, thank you for standing by. Welcome to the OncoNova Therapeutics First Quarter 2023 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.
Speaker 1: To ask a question at this 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, May 15, 2023. At this time, I would like to turn the call over to Bruce Mackel of Lifestyle Advisors. Please go ahead, Bruce.
Speaker 1: Thank you, operator, and welcome everyone to Anka Nova's first quarter 2023 financial results and business update conference call.
Speaker 1: Earlier this afternoon, Ankenova 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 Ankenova.com.
Speaker 1: Following my introduction, we will hear from Ankenova's president and CEO , Dr. Steve Fruckman, interim chief medical officer, Dr. Michael Saunders, and chief operating officer and chief financial officer, Mark Garen. Ankenova's VP of regulatory affairs and quality assurance, Fred Froulo.
Speaker 2: will also be available during the Q&A session following the prepared remarks.
Speaker 2: Before we begin, I would like to remind everyone that statements made during this conference call will include forward-looking statements under the safe harbor credence of the Private Security's litigation reform act of 1995.
Speaker 2: which involve risks and uncertainties that can cause actual results to differ materially.
Speaker 2: 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, Ankenova disclaims any obligation to update these forward-looking statements to reflect future information, events, or circumstances.
Speaker 2: 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.
Speaker 2: With that, I will now turn the call over to Ankenova's President and CEO , Dr. Steve Fruckman.
Speaker 3: Thanks Bruce.
Speaker 3: Thanks Bruce and thanks to all for listening.
Speaker 3: Before we provide our update
Speaker 3: Chief Medical Officer, Dr. Mark Gelder. Mark made many valuable contributions to Ankenova and had a very distinguished career as a biomedical innovator and oncologist dedicated to advancing the care of patients with female reproductive cancers. We continue to work tirelessly.
Speaker 3: Medical Officer, Dr. Mark Gelder. Mark made many valuable contributions to Ankenova and had a very distinguished career as a biomedical innovator and oncologist dedicated to advancing the care of patients with female reproductive cancers. We continue to work tirelessly to honor his memory.
Speaker 3: through the advancement of our clinical programs and endometriol and other cancers. And we are immensely grateful for the time we got to spend together. In addition to a colleague, we lost a friend and a very good man. Although big shoes to fill.
Speaker 3: Dr. Michael Saunders, our interim chief medical officer, is an amazing clinical scientist with a remarkable track record of success.
Speaker 3: and developing some of our most innovative therapeutics.
Speaker 3: For patients with advanced cancer.
Speaker 3: I want to thank Michael.
Speaker 3: for his efforts.
Speaker 3: during these very difficult past few weeks.
Speaker 3: For our update today, we will focus primarily on two topics.
Speaker 3: The first will be the progress of our ongoing phase one, last two-A trial of Nerazocyclib combined with Lettrezo in low grade endometrioid endometrial cancer.
Speaker 3: which as announced this week had the first patient dose.
Speaker 3: announced this week had the first patient ghost on the study.
Speaker 3: The second point will be our plan regulatory interactions around MIGO SERV's Phase II program in odd-deb or recessive dystrophic epidermalysis polosa associated squamous cell claustronoma.
Speaker 3: Which would be subject of it.
Speaker 3: FDA type B meeting request.
Speaker 3: These developments are like...
Speaker 3: But was a very productive quarter to Ankenova. For those interested in details on our progress.
Speaker 3: In our additional clinical and pre-clinical programs, I encourage you to see our recent press releases detailing key meetings.
Speaker 3: where our science is presented, including our earnings released issued earlier today.
Speaker 3: With that, I'll introduce our interim chief medical officer, Dr. Michael Saunders.
Speaker 3: As I stated, but it is worth repeating.
Speaker 3: Michael is a deeply experienced drug developed.
Speaker 3: With extensive knowledge of our programs, thanks to his work as a...
Speaker 3: Thanks for your time.
Speaker 3: to Anka Nova for over the past two plus years.
Speaker 3: Prior to this, his most recent role was as Executive Director of Drug Safety and Pharmacovigilance for Array Biofather and Pfizer.
Speaker 3: Michael, please go ahead with the update.
Speaker 3: Michael, please go ahead with the update. Thank you for that very kind introduction, Steve.
Speaker 4: I'll begin my portion of today's call by reporting that Narasa Cyclib has continued just to display an acceptable safety profile in the Phase I monotherapy trial evaluating a continuous daily dosing schedule in participants with solid tumors.
Speaker 4: Patients are on the 240 milligram cohort, and as we dose escalate, we are starting to see the effects of CDK46 inhibition on bone marrow function. Telling us, we are engaging our targets, but without seeing any clinically meaningful cases.
of Neutropenia or diarrhea, which are those limiting toxicities associated with the FDA approved CDK-4-6 inhibitors among additional toxicities seen with agents targeting a variety of CDK pathways.
These findings suggest Nareza Cyclib may overcome the safety and tolerability shortcomings of these agents and indicate the Phase I program as accomplished is subjective of providing the information needed to confidently advance our program to the next stage of development.
which we already initiated in the trial of Neurazocyclid in combination with Lethrazole in the Endometrial Cancer. Thus, during the next stage, we will evaluate the safety and efficacy of Neurazocyclid-based combinations in specific indications.
For those familiar with our plans, the first indication we're targeting is recurrent low grade intometroid, intometrial cancer or LGEEC. Last week, the first patient was dozed and it phased one slash two A trial. Ok next take two or three screens in a quick, simple mode.
in this indication, which is on track for a preliminary data weed out in the fourth quarter of this year. Recurrent LG EEC was chosen as NARA, NARA's cyclops first target indication because it marries a clear need or improved therapies.
with what we believe is a high probability of technical and regulatory success.
based on compendial listings, patients with recurrent LG EEC are currently treated off label with a lechrosol combined with one of the CDK46 inhibitors, palbocyclid, ribocyclid, or a bena cyclic.
which are approved only for the treatment of hormone receptor positive, per-two negative breast cancer. While these compendial listings are based on the results of both single arm trials and a randomized study that demonstrated improved clinical benefit based on the improvement in progression-free survival with the combination of lectrisol and palbocyclid versus lectrisol alone.
It's clear that the off-label combinations currently employed are marked by short-termings related to safety, fallibility, and treatment resistance.
We believe NARAZO cyclists have a high probability of technical and regulatory success in LG EEC.
Because light, power cycle, drive the cycle and the bend the cycle, it inhibits C to K4 and C to K6 with high potency. However, in addition, we also potentally target a novel protein above one.
The overexpression above one has been correlated with poor outcomes in certain cancers, including breast and endometrial cancer. This data was presented at the recent AACR meeting and Orlando. Therefore, the NRAZA cyclib
Lethrezole combination targets endometrial cancers for the mechanism of action for which clinical proof of concept has been demonstrated.
It is worth repeating that in addition to targeting CDK4 and 6, Nerasocyclib and Hibis kinases not targeted by the aforementioned commercially available agents. These include a variety of important kinases, such as the previously mentioned above wine,
which also, which was shown in a presentation at a SOAR last month to be associated with poor survival and a key subtype of endometrial cancer.
NRAZocyclin's ability to target these additional kinases such as CFF-1R and ARC-5 together with clinical safety findings to date. I referenced earlier, fuel, our belief that a NRAZocyclin, blood-resolved combination, can provide LGEC patients.
with a much improved treatment option. Beyond LGEC, we continue to evaluate opportunities for combination studies of Narev's cyclop and additional indications and presented data at AACR last month that provide evidence of its potential.
to combine synergistically with a variety of therapeutic agents and additional indications. We expect to begin at least one additional combination study of Nerasa cyclops by the end of the year, and we'll provide additional details once a clinical protocol is finalized.
Next, I'd like to speak about reg assertives, investigator-sponsored phase two program, in advance, Scream-as-Cell, carcinoma, complicating, recessive, dystrophic, epidermalysis, blosa, or RDEB associated SCC, as it is often referred to.
The most recent data from this program show that both initial and valuable patients achieving complete clinical responses of all cancerous skin lesions.
The responses are durable. We're seeing with either intravenous or oral regicertive administration and regicertive has been well tolerated with no additional toxicities in this subset of cancer patients with an unusual defect of their of having genomic mutations of collagen seven.
This data was presented last week at the International Society of Investigational Dermatology Meeting with enormous interest from the international experts in the disease.
Excitingly, new additional patients were identified at the meeting to be consolidated onto or considered onto study entry.
These patients are also rare and we are very pleased to have identified additional patients whom we hope regal surgery will be as helpful to as with the patients already treated to date.
Well, these data are only from two patients. It's important to realize that our Deb associated SEC is an ultra rare disease with extraordinarily high unmet need. The cumulative risk of death is tragically 70%.
by the age of 45. Once recurrent metastatic squamous cell cancer occurs following surgery, it is almost always invariably fatal with no effective treatment options.
Because of this high and urgent unmet need, we believe that most prudent next step for the program is to discuss our early findings with regulators to determine the optimal most expeditious path for the board's and NDA filing and potential approval. In this regard,
We have requested a type B meeting with FDA based on regulatory timelines associated with the type B meeting we expect to provide an update on ligusertips regulatory pathway in our DAB associated FCC in the third quarter.
After we have completed the type B meeting and received written feedback.
Notably, regular-surviv results in RDEB associated FCC may have positive read-through into more prevalent indications as a key driver of the disease is PLK1.
A kinase that is over expressed in other cancers and is potentally inhibited by Rig assertive. To further explore this possibility, we recently began collaborating with Pangaea BioMed.
to use their proprietary tumor intelligence probe platform to identify biomarkers that should predict patient response to reg assertive. This platform makes predictions by evaluating in vitro preclinical and clinical datasets to build
genetic social networks that reveal tumor vulnerabilities to specialize, and specified therapies.
These analyses are focused both on regal surge ability to inhibit PLK1, as well as the other pathways targeted by its multifaceted mechanism of action.
There was also these collaborative analyses made in form and artificial intelligence driven precision medicine approach toward selectively identifying additional indications and biomarkers for regicertive potential efficacy evaluation. The last studies I'll speak about today are two investigator sponsored trials.
in this study, which is being conducted in collaboration with investigators at Vanderbilt University Medical Center.
who are sponsoring the trial and and Mert who is supplying to Trudeau.
And lastly, I would provide a brief update on the phase one slash 2A trial of regicertive combined with briswimire squibs optivo and K-RAS mutated non-small cell lung cancer patients who have failed prior therapy with PD-1 checkpoint inhibition.
This trial continues to approve patients at the dose featured in our most recent data update on the trial, namely, 560 milligrams twice daily for three weeks on and one week off, which was presented at ESMO last year and showed an encouraging signal of efficacy.
with a studied doublet across multiple K-RAS mutations. Based upon these results, as well as an acceptable safety data from the trial to date, the protocol has been amended so that we can assess.
further increasing the dose of rig assertive in the trial, which will lead to an enhanced efficacy signal as well as continued acceptable safety.
We plan to present data on patients receiving the increased dose of rig assertive alongside a broader update from the trial.
Taking into account the time needed to enroll patients on the higher dose, we now expect to report updated data from the trial in the second half of this year.
With that, I'll conclude my remarks and my portion of the call and hand it off to Mark. Thank you.
With that, I'll conclude my remarks and my portion of the call and hand it off to Mark. Thank you, Mike.
On Canova closed the first quarter of 2023 with cash and cash equivalents of $34.2 million compared to $38.8 million as of December 31, 2022. Based on our current projections, we believe that our cash position will be sufficient to find our ongoing clinical trials and business operations.
Test key clinical and regulatory milestones and into the first quarter of 2024. Research and development expenses for the first quarter of 2023 were 4.1 million compared to 2 million for the first quarter of 2022. Thank you.
General and administrative expenses for the first quarter of 23 were 2.1 million and this compares with 2.2 million for the first quarter of 2022. Net loss for the first quarter of 2023 was 5.8 million or 28 cents per share.
on 20.9 million weighted shares outstanding. This compares with the net loss for the first quarter of 2022 of 4.1 million or 20 cents per share on 20.9 million weighted shares outstanding.
The increase in net loss for the first quarter of 2023 compared to 2022 was primarily result of Narazasite Globe clinical development and manufacturing expenses in the 2023 period. With my financial review complete, I'll now hand a call back to Steve for his concluding remarks.
for the first quarter of 2023 compared to 2022 was primarily result of Neurazosite Globe clinical development and manufacturing expenses in the 2023 period. With my financial review complete, I'll now hand a call back to the?th Wednesday and III, II B. with the card of time before sworn in for his especialmente results in previous
Thanks, Mob.
I conclude by reminding listeners that you've seen remarkable efficacy data.
When regor certain in odd dead squamous cell costs a normal.
and very encouraging data across various care-ass mutations.
and K-RAS mutated non-swells lung cancer.
Our progress has us on track.
to achieve several important clinical and regulatory milestones this year.
They fucking??...
One, the first readout to establish the Covenation Dones.
The Marfayze 1-2-A trial of Neurazocycline with Lettrezole in Endometrial Cancer. 2-A trial of Neurazocycline with Lettrezole in Endometrial Cancer.
an important regulatory update on legal certits on their associatedakisinolyn Ulham, Grande Missotebol us an healthy lymphoma febinary physician has a 18 sculpture herbidosale when there is still a? of smelling
and three updated efficacy and safety data to include additional patients.
from the phase one slash two-eight trial of regal serenade plus a vivo in not small cell long caras mutated cancer.
We are on track for these milestones due to the hard work about our employees.
We are on track for these milestones due to the hard work about employees, partners, and investigating.
And mostly
Due to the bravery and dedication
and bravery and dedication of our clinical trial expert participants.
I thank each of these individuals for their important contributions.
With that, we will begin today's Q&A session.
And operator, I will turn it over to you and thank you. Ladies and gentlemen, if you wish to register a question for today's question and answer session, you will need to press the star then the number one on your telephone keypad. If your question has been answered and you wish to withdraw your request, you may do so by pressing the pound.
Your first question comes from the line of Joe Pant Guinness of HC Wainwright. Please go ahead.
Hey everybody, good afternoon. Thank you for taking my questions. But first, let me offer my condolences for the big shock of Mark's loss. It was great for the team. It was great, man. So it's very sorry to hear that. So first, I wanted to ask about Norez's profile here. So...
As you're looking to push the dose in the phase one and dosing within the LG EEC study, I was just curious, will or when or will you expect to eventually see the hematologic adverse events or or and or will you expect
still some lessened impacts on the adverse event profile due to how the drug hits the kindom treat.
Well, thank you, Joel. I'll take that question. And the answer is, you don't really know until you continue to dose escalate.
But we're already starting to see something...
minor decreases in total white counts.
and ANC of the patients. So that's why we believe we're getting close.
And for that reason, Joe, translating the monotherapy trial with nirazacyclic, we've already opened a doublet trial. Usually, as you know, you wait for the recommended phase two dose before you do combination studies, to expedite our timelines because...
As you follow the white guy, you could start to see a decrease. We recognize that we're probably getting close and thus was able to open the endometrial cancer trial in combination at one dose back from where we were when we started that study at NYU. Well.
Ration now makes perfect sense as what we get
Loser, the single aging recommended phase two, therefore will expert that are understanding which is the most important question because these drugs are always given in combination with anti-SIS agents, and we're already doing that in the NYU phase one and the meteorotrial.
Got it, got it, thanks for that. And switching over to RIGO CERTIM for our Dev Associated SEC. Obviously, the big thing we're looking for, as you mentioned, is the feedback from your type B meeting. And we discussed this previously, but if you wanted to highlight again some of the wishlist coming from that. But the main part of my...
with or will you be working with organizations like DEBRA, you know, that really have the pulse of the, our DEB population or the DEB population.
Yeah, Joe. So it's amazing to meet you how rapidly you become an expert in whatever science and clinical information that the company's you cover. So, Deborah is the main international non-national nonprofit. There's some language slipping, please.
involved in this disease. Leadership of Deborah typically has children. We suffer from our death. And at the meeting that we just presented in Osaka in Japan, Deborah was very well present there. Many of the investigators, including ourselves, by the way. I don't even know this, our trial.
coming out of Philadelphia is supported by Deborah. So the experts in the world who all present us in a circle are very impressed.
with a disease that's invariably lethal. Once a recurrence squamous cell occurs, not just the fact that it's lethal.
No therapeutic maneuvers work. And the responses we've seen with Rodrigo Serta, in my humble and clinical opinion, are totally remarkable.
You could have these masses of fungating cancer to disappear.
So based on the responses we're seeing, as Michael said, we're going to interact with the agencies, show them our data, because what we really need is guidance from the agency in an ultra rare disease with a tremendous unmet medical need, how many patients would they like for us to have to get approval?
The other thing that came out of Osaka, we've already identified additional patients throughout the world because the caregiver for these patients are all present in Osaka. That's another very important development for us to be able to put additional patients on and hopefully preliminary results with either IV or we are sort of...
of Leningrad. Please go ahead.
Good afternoon team. Thank you for taking my question and congrats on the quarter and in addition my finalist is on Mark's Law says that it was a pleasure to work with him. A few questions from us. First one is on the Narza Green Gosation. I give a five liter acronym program and on the Thay Community
Could you comment on the CDK46 activity in the endometrial cancer? As we know, I think it's not approved, but it is used in the patient. So if you could maybe provide some color on the percentage of patients who treated with CDK4, and also are the...
Patients excluded if they have CDK46 treatment previously. So I cannot comment. I think you question is how many patients in the US treated off label with the FDA approved CDK46 inhibits? I do not know the number. I know.
giving in combination with the mental estrogen and there have been clinical trials and that's why they're used off label, suggesting that progression free survival.
of the combination of ACDK46 inhibitors, specifically palblos cycloplastletrizole, prolonged www.pBS-courtes.com www.pBS-courtes.com
A two and a half to three times what it was with lectures all alone. But the clinical data, the interrandomized trials, supports our approach. The fact is it does not have FDA approval in this indication. And we believe, because these two of them are driven.
by CDK 4 and 6 are driven by estrogen as is breast cancer that our logic is good to pursue the endometrial cancer space and we are excited by our first patient. We anticipate the recommended phase 2 dosing of the combination should be done.
before the end of this year. That's helpful Steve and our patients are excluded each a patient received a K46 previously. Are they excluded in the trial?
The answers I do not believe they are because we believe are differentiated who based on they could have been given, let's say one of the SCDK4-6 inhibits and they stopped it for instance to the safety concerns, be that neuterpini or diarrhea and because we target
We differentiate also because we target resistant pathways in these diseases. Patients who have failed the FDA approved CDK46 inhibitor will be permitted on the trial. Again, the goal is to get the dose. It's really not an efficacy trial. It's really to get the optimal dose of the combination, not necessary to study efficacy.
and a phase one study with no control. Thank you. Your next question comes from the line of Robert LeBouillet of Noble Capital Markets. Please go ahead.
Thank you. And first, I'd like to offer my sympathies on Dr. Gendler's loss to the company and the family. My question has to do with the solid tumor trial and whether the timeframe for announcing results has been established.
And what you're expecting going forward. Rob, when you say this on a two-metre, are you speaking both of the RASA cycle and we go asserted?
I could take both of them to which compound you're asking.
AB2 at TTime
So we anticipate.
the recommended phase two dose in endometrial cancer, as I mentioned before the end of the year. Once we have that dose, then our plan will be to initiate a randomized pivotal phase three trial in the same indication studying the rhizocycline plus letrozole versus letrozole.
by a complete response and partial responses, seen in highly refractory KRS, and J.Dance Moscal lung cancer. And as we've discussed previously, not just the interesting response rate that we're seeing, but the fact that we are mutant.
agnostic, we have responses in at least three different k-rats mutations which
There is no other drug that is FDA approved that does that as you know the approved drugs only target G12c approximately 20 25 percent of all patients may have a mutation of G12c so the 70
80% of the other patients have other mutations that we hope to target. We anticipate that study also coming to completion in 2024, I'm sorry, in 2023 by the end of the year. But as Michael mentioned, the cause of safety appears to be very accepted.
with the combination of regal, assertive and the volumap, we may make a decision to continue to dose, escalate the regal, assertive. In fact, to doses that we have not given to patients previously, I can't predict the safety profile, but we really want to make sure we have optimized the efficacy.
all of that, we may make a decision to continue to dose, escalate the regal syrup. In fact, to doses that we have not given to patients previously, I can't predict the safety profile, but we really want to make sure we have optimized the efficacy
For this combination, we believe by increasing real sort of if the safety permits us to do that, we will be confident that we will have the most effective systems of the combination.
Okay, great, thank you very much. I'm showing no further questions at this queue. Operating, if I can interrupt you, I realize, and I thank Joe for not stopping me. I didn't answer both of Joe's questions, and I like to take an opportunity to do so. Joe was also asked about commercialization regarding squamous cell RDEB, and I didn't answer that question. I'd like the opportunity to do so, Joe. Go ahead.
would be to get regostrate of approved in this ultra rare disease just to get regal the invalid of the value of regostrate of...
is extremely valuable to Anka Nova. After the previous studies done we believe in them, stated many times we believe we're on the right path by studying squamous cell, complicating our doubt, the quality of the science that brought us here, but in addition to this very rare disease.
There are more common way missiles of humanity. Also due to damaged skin, it's just that the spontaneous squamous cells not complicating why they're dead, but the damaged skin is from thunder, for instance. Patients who have too much sun exposure may also develop squamous cell cross-synoma.
All this gramous cell costanomas exist as well. Scramous cell, for instance, stuff the lung, which is probably due to other environmental toxins that we inhale, damage the lungs, the cervical gramous cell as well. So there's a variety of scramous cells that we did a more common, that we can attempt to address. And the question that we're working on with both Pangaea and others.
lung, skin, cervix, etc., and neck as well, which I neglected to say, what is the overall percentage of PLK-driven squamous health? Because that is a group we'd be very interested in studying, and a group such as that would be a very large commercial success, we believe.
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. The
Well, thank you all for participating in today's call.
We are pleased to be approaching very important milestones across our pipeline and look forward to providing additional updates as they are achieved.
Thanks again for participating and have a great evening.
Thanks again for participating and have a great evening. Goodbye.
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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