Q1 2021 Onconova Therapeutics Inc Earnings Call
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Ladies and gentlemen, thank you for standing by.
Welcome to the Anika that therapeutics first quarter financial results and business update conference call.
At this time, all participants are in listen only mode.
Following managements 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 two day may 17th 2021 I.
At this time I would like to turn the call over to Avi Oler Senior Vice President of corporate development and General Counsel.
Thank you good afternoon, everyone and welcome to <unk> 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 dot onto Nova Dot Com on today's call Dr. Steve Fruchtman, 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 final.
Actual results following remarks reports will move to the Q&A portion of the call and will be joined by Dr. Steve Because then the 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 law.
<unk> and reform Act of 1095, which involve risks and uncertainties that can cause actual results could differ materially forward looking statements speak only as of the day. They are made as the underlying facts and circumstances may change, except as required by law I'm cutting other disclaims any obligation to update these forward looking statements to refer.
But future information events or circumstances for 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.
Thank you Avi.
Good afternoon, everyone and thank you for joining us today.
As the COVID-19 pandemic is being brought under greater control and some are tragically not in all geographies.
The scientific advances advances of colleagues from around the world.
We hope you and your loved ones remain safe and healthy.
Despite the hurdles COVID-19 placed on the clock.
Conduct of clinical research.
For noble 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 <unk>.
And went to three 300.
Or simply referred to as 123.
As a reminder, 123 is a proprietary first in class multi kinase inhibitor targeting CDK for CDK sick and arc five.
It works by simultaneously inhibiting book.
For sales cycle.
And cellular metabolism.
For Cdk's and oxide respectively.
Rich maybe over expressed.
Number of cancers.
In vitro data show that one Q3, maybe cytotoxic cancerous cells.
Meaning it kills cancer cells.
Rather than merely inhibiting their growth with.
Just how the currently available CDK inhibitors typically work.
We believe that with a mechanism of action targeting CDK for CDK.
All five and other kinases, such as net free.
Q3 represents an innovative approach for treating solid tumors and hematologic malignancies debt of refractory ore book.
From resistance to the current CDK for six inhibitors.
Yeah.
Additionally.
123 has shown superior CDK for inhibition.
<unk> improved on.
Okay.
Hey.
Okay.
It was widely prescribed second generation CDK for six inhibitor Powerball cycling in a multitude of preclinical studies.
We believe this presents an opportunity for continuous daily dosing of 123.
Which may lead to improved efficacy as payables cycle them and another second generation CDK for six inhibitor ribose cycling.
Prescribed in combination with an anti estrogen agent and then three weeks on one week off treatment schedule.
Due to issues of tolerability, including side effects related to neutropenia less.
Thus the need for a one week off scheme.
Based on the clinical data mentioned above.
Adjusting for 123 causes less marrow suppression.
<unk> cycled does.
We plan to evaluate a continuous dosing schedule.
123 in a phase one study in the U S.
We are continuing to advance this study and I'm delighted to have initiated sites and open this study for enrollment.
We expect to dose the first patient in this study sometime during the second quarter of this year as investigators evaluate patients for inclusion.
Progress is continuing with other ongoing phase one study with our partner <unk>.
Our next pharmaceuticals.
At this point in China, two dosing cohorts have been completed with 123, appearing to be well tolerated with no dose limiting toxicities observed to date.
I'm also pleased to announce debt.
Third cohort evaluating <unk> 120 milligram dose in this study.
Now open for enrollment.
Together, the handouts and U S studies aimed to provide complementary inflammation.
Well design.
Subsequent trials.
And that study is dosing patients on day, one through 'twenty one right.
A 28 day cycle.
While the U S phase one study.
Valuation continuous daily dosing as I mentioned already.
Our current plan is for the phase one trial in the U S to assay assess.
Safety, Tolerability and pharmacokinetic profile of <unk>.
123 administered as a single agent and increasing doses starting at 40 milligrams daily to consecutive 28 day cycles in patients with advanced cash.
This includes but is not limited to patients with hormone receptor positive had two negative metastatic breast cancer with resistance to the approved second generation CDK four and six inhibitors.
We anticipate a total of three phase one sites in the U S.
And believe the day to day generate in conjunction with the phase one data generated in China.
Well established a recommended.
Dose and treatment regimen for a future phase II basket trial.
That will enroll patients with several different types of cash so that over express <unk>.
I haven't seen kinase targeted by 123 in addition to CDK four and six.
Based on preclinical models.
The Spa, we have identified two potential target indications for this future basket study.
We plan to enroll approximately 36 hormone receptor positive her two negative metastatic breast cancer patients who are resistant to the approved second generation CDK for six inhibitors as well as patients diagnosed.
With advanced non Hodgkin's lymphoma.
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 it.
No target indications, we will evaluate.
We're very excited about one Q3's potential to improve outcomes for patients compared to the current approved she became for six inhibitors for the indication of hormone receptor positive her two negative metastatic breast cancer.
And in other indications as well and look forward to announcing for.
Other clinical progress from our two ongoing trials throughout this year.
We view hormone receptor positive <unk> negative metastatic breast cancer as well as additional potential indications as a large commercial opportunity.
For 123.
Total worldwide sales.
The three approved CDK for six inhibitors it free.
<unk> $6 billion in 2019.
Yeah.
I'd like to discuss some of the progress we've seen in <unk>.
Several investigator initiated studies.
Value waiting Regal circuit, our rash targeted product candidate, which has also been shown to have the important capacity to promote the thule infiltration.
Anti cancer immune cells in preclinical studies that we've presented.
At the American Association of cancer Research in 2019.
This is an important observation.
Which hopefully will improve patient outcomes when the immuno oncology drugs are prescribed.
For expanding the potential indications.
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.
Investigator initiated phase two study with Regal sorted mono therapy in advanced squamous cell carcinoma associated with recessive dystrophic epidermolysis below.
A terrible genetic skin blistering disease.
We are very encouraged by the start of this trial.
We hope rigorous service proved.
Proved 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 sort Salzburg in Austria.
And additional sites are anticipated to be open in both the UK and the U S.
Months.
In this open label investigator initiated study 12 patients who received either oral or intravenous rigo sooner at the Commission's discretion.
Physicians will have a choice of route of administration.
Because of the various clinical manifestations of this disease, which may dictate whether all for.
Intravenous administration of Ricoh Circuit is the preferred route.
These patients have terrible squint desk grew skin desk formation, which make intravenous at axis.
And administration difficult.
And others May have esophageal strictures, which make oral administration difficult.
Patients will receive either oral rigo asserted in full week cycles, including three weeks on one week off for up to 13 cycles.
Alternatively patients who will receive intravenous regards sort of.
As a 72 hour infusion on day, one two and three.
A two week cycles and day, one two and three of nine four week cycles thereafter.
Overall, we are very pleased with the clinical milestones achieved with both 123 and we go surround them during the past few months.
Very importantly is the progress of a phase one two trial in patients with advanced K Ras mutated non small cell lung cancer that is being conducted with Regal asserted.
Combination with a PD one inhibitor the volume add more commonly known as Opdivo provided kindly by Bristol Myers Squibb for this study.
This study has a per.
Retention to address a critical unmet medical need S. K Ras mutations.
Predominant predominant genetic driver.
Non small cell lung cancer and there is currently.
Lack of effective treatment options for Pep for patients who progress on first line therapy.
Checkpoint inhibitors, such as Abbvie, though are among the world's top selling pharmaceutical products.
Spite, some tumor micro environment.
Lacking the prerequisite of.
Immune cells surrounding interest.
And for trading the tumor and thus potentially limiting the efficacy.
Based on the preclinical findings presented.
ACR or American Association of cancer Research meeting in 2019 that I mentioned, a few moments ago rethink Regal certainly has the potential for not only target the K Ras mutations in these patients but also to enhance.
Hence the efficacy.
The checkpoint inhibition of the combination by promoting the infiltration of cancer fighting immune cells into the tumor.
And thereby.
Freezing.
Can show efficacy.
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 Regal assertive per the current protocol in combination with full dose Navona Matt.
Depending on dose limiting toxicity.
<unk> the lead investigator is considering.
To amend the protocol to further dose escalate all Regal asserted.
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.
To characterize its safety profile.
Secondary objectives include the preliminary evaluation of efficacy.
Buyer 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 K Ras mutations and the immune status other tumors.
Also being studied.
We plan to update you further as the study matures.
Looking ahead.
We believe the novel combination of Riga, assertive and checkpoint inhibitors is a potentially meaningful option to pursue in lung cancer.
And other disorders with K, Ras mutations managed with immuno oncology therapies.
Our hope that this program will offer patients who have progressed following first line therapy.
Net potential.
For patients second line approach.
Advanced malignant melanoma is one such indication we are interested in pursuing.
Another investigator initiated study in this indication.
Under review based on the ACI data mentioned earlier, demonstrating regal sort of effects on the immune system and its ability to promote tumor infiltration with lymphocytes.
This study would potentially evaluate reversal.
Combination with Pembina lizabeth willing to commonly known as Keytruda and.
Another checkpoint inhibitor that could benefit.
From the infiltration.
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.
While we are very interested in the outcomes of ongoing and potential potential investigator initiated studies.
We intend to preserve our primary focus and resources on our lead compound or in one Q3 300.
Finally.
With me guidance to our previously announced COVID-19 work we.
We are still awaiting word on our funding request for the National Institute of allergy and infectious diseases and the biomedical Advanced Research research and development authority for potential clinical trials with rigorous hurdle.
In the interim additional preclinical work is ongoing and it's being a weighted.
And now I'll turn the call over to Margaret for a discussion of our Q1 results.
Mark.
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.
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 or we can sort of combination program and the recently completed phase III inspire study in the 'twenty, one 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 <unk> <unk> per share on $219 2 million weighted average common shares outstanding. This compares with a net loss for the first quarter of 2020 was $5 1 million or <unk> <unk> 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 for the achievement of significant milestones, including pursuing corporate development opportunities.
This completes my financial review I'll now turn the call back to Steve.
Mark Thank you.
In summary.
We have several key near term milestones.
And value drivers ahead of us.
One <unk>.
Begin dosing patients in the second quarter of 2021.
In the U S phase one trial.
Oh, and one to three 300 and advanced cancers.
Including metastatic breast cancer patients, who are refractory to approved CDK for six inhibitors.
Two.
Enrollment in the next cohort.
As one trial of O N 123, 300 in China.
Three our pipeline of investigator sponsored studies with Regus is.
<unk> is advancing.
Including establishing a dose for <unk>.
For this study the combination of all of it goes through them and Opdivo in K Ras 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.
For and finally.
We continue to actively evaluate strategic licensing opportunities to enhance our product portfolio.
As with all of our decision.
Any decisions on this front will be driven by science and the potential for clinical benefit and 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 all.
Operator.
Ladies and gentlemen.
It'd be weighted to register for a question for todays question and answer session you.
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One moment please for the first question.
And you have a question from Doctor, Joe <unk> from H C Wainwright.
Hi, This is Nick on for Joe. Thanks for taking the question I actually have two questions.
You mentioned you recently started area to start that study in the patients with price.
The guest traffic at the tumor lysis Melissa.
And I'm just wondering if you had a little bit more into the end points, especially when the landscape for treating the underlying diseases.
Likely dramatically changing thing with gene therapy, specifically, the chronic wounds and these patients are still in flame, usually how does that how does something like this impact the assessment of our seafood, Wisconsin.
Well, thank you for that share, but you you've already answered your own question in a way for these it sounds like you know a lot about this very rare condition necessary rather tragic condition.
These patients have terrible blistering skin they day, new their skin to have a tremendous inflammatory component the skin gets infected.
There is nothing that is efficacious for these patients so the endpoint for basically beach observation of their skin.
Observation of the blistering that involves asking for.
Laboratory component debt.
Visited by that blistering and to see if we go sort of impact on the skin condition.
Many of the patients from Continentally also have developed as a result of the underlying after them a license below show squamous cell carcinoma.
If they have squamous cell carcinoma patients eligible for eligible for the trial or do then that's typically for a cancer trials. The squamous the size of the squamous cell carcinoma will be measured and to seize control is achieved for these patients given either IV or oral rigo standard.
And that choice is made based on clinical parameters that I discussed.
Okay. Thank you and my second question you touched on this a bit with the lung study having reached its highest Jonathan Lakota call can you point to what the communication strategy is from that investigator around this study.
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.
Cores.
At the highest dose.
Sufficient number of <unk> has not been observed.
Investigator will have the option with our approval by ACA, Nova to continue to dose escalate all V go share them until a sufficient number of D. L teaser observed in combination with full dose and the volume that we wanted to be confident that we have the.
Best dose of all legal assertive in combination with Novartis on that so.
<unk> phase two trial in this indication potentially can be conducted so that will be that decision be made after an interim analysis.
Looked at and if any additional <unk> seen its not the option to continue to dose escalate.
Okay. Thank you.
Youre welcome Sir.
Yeah.
Yeah.
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 for all of you for participating on today's update call.
As we've discussed.
Overhead 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.
Sure.
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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