Full Year 2020 Onconova Therapeutics Inc Earnings Call
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Ladies and gentlemen, this is the operator todays conference is scheduled to begin momentarily until that time your lines will be placed on hold thank you for your patience.
[music].
Yeah.
Okay.
Ladies and gentlemen, thank you for standing by well go on city on Carnival 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 cash.
Just on fun, if anyone has difficulty hearing the country. These fresh 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 Abbvie older Senior Vice President of corporate development and General Counsel.
For each thank you operator.
Good afternoon, everyone and welcome to <unk> 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 on the investors and media section of our website at Www Dot Hakan, Nova Dot com on today's call Dr. Steve Fruchtman, President and CEO will discuss the company's recent highlights and anticipated clinical and business milestones and then Mark Guerin, our chief financial.
As for Officer will review, our 2020 financial results. Following March report will move to the Q&A portion of the call and will be joined by Doctor, Steve cause them to lead scientist before we begin I'd like to remind everyone that statements made during this conference call by management will include forward looking statements under.
The safe Harbor provision of the desk 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 day. They are made.
As the underlying facts and circumstances may change, except as required by law on kind of a disclaims any obligation to update these forward looking statements to reflect future information Spencer 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.
Thank you Avi.
Good afternoon, everyone and thank you for joining us.
We continue to hope you.
Colleagues and your loved ones are safe.
And healthy.
We are living an amazing times.
Witnessing the power of nature.
And the dramatic influence key scientific discoveries.
Half.
To help human kind.
They truly are.
Extraordinary year.
Right.
The progress to enter the clinic.
We.
And advancing our multi kinase inhibitor.
And one to three 300.
Which I will refer to as Oh, and one to three.
I want to thank our stockholders for your tremendous support.
Well aren't you know over the years.
I also want to ask our stockholders of record.
As of January 12.
Have not yet voted to vote today and aren't getting overs stockholders' meeting.
The board of directors firmly believes that the stockholder proposals to change our capital structure by a reverse stock split.
In the best interest of stockholders.
Turning out to vote.
Jared.
For the company to execute its tejas plan from a strengthened position.
We believe the approval.
All of these proposals.
Well what.
And sure we may.
Maintaining our NASDAQ listing.
Two.
A higher stock price will increase.
Company's appeal.
And permit institutional.
And from the mental.
Oh Tech investors.
To invest in on can know.
And three.
<unk> court in licensing programs.
Evaluation.
We believe approval of the proposals.
Need to continue to progress new.
On existing programs and create long term value for stockholders.
We urge all stockholders, who have not yet voted please vote today.
At the March for a special meeting.
Which was a journey.
April 1st more than 70 per cent of the shares which had voted for.
Voted in favor of two proposals.
One.
For a reverse stock split and two for.
On a decrease in the number of our authorized shares.
However.
We did not meet the required threshold.
For approval of more than 50 per cent of the.
On the shares.
For the two proposals.
In addition to the support of our stockholders who voted.
All three independent proxy advisory firms.
I S S.
Glass Lewis and Egan Jones.
Recommends its stockholders vote for.
For the proposals.
Their support.
Just on their view.
Then a yes vote is in the best interest of stockholders.
The stockholder meeting process is also costly.
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 Mackenzie partners. If you have any questions regarding the proposal.
Email us at ladder.
Is that on our I'm going over got U S.
We announced that we will make a $50000 donation to the American cancer Society.
We can achieve 70% or more boating participation by stockholders of record on January 12th regardless of how the stockholder vote.
As our focus is on study cancer indications with our novel compounds, we believe that supporting the important work from the American cancer Society two.
Thank our shareholders for voting.
It's 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 over in 123.
The fourth quarter of 'twenty 'twenty.
And recent weeks have been very active and productive as we continued preparations to advance Oh and went to three into the clinic.
In the United States.
We submitted an investigational new drug application to the F. G H for.
A phase one study in advanced cancers, including hormone receptor positive her two negative metastatic breast cancer patients refractory or resistant to.
So health authority approved.
Dk for six inhibitors.
In December of 'twenty 'twenty, we received clearance from the FDA to begin a phase one study and have since received institutional.
Review Board for IRB approval at our first site.
We expect that the first patient will be enrolled in this study some time during the second quarter of this year.
Two additional sites are in the study set up process.
With three phase one site, we expect we will be able to expedite that timeline to the important milestone of establishing a recommended phase two dose.
We anticipate three.
Phase one site in the U S in conjunction with the Phase one trial being conducted with all in 123 in China.
Establish the recommended phase two optimal dose.
Study.
Different cancer indications that over express the tie.
Tyrosine kinase targeted by O N 123.
In addition to CDK four and six.
These phase one studies were assessed for safety.
Tolerability.
Pharmacokinetics of O N 123 administered orally.
Increasing doses starting at 40 milligrams daily.
Tenuously 28 day in the U S study.
Sure.
Three out of four weeks in this study in China.
These two different administrations schemes mimic different administrations schemes use for the three FDA approved CDK four and six inhibitors.
And we believe.
Port finding the optimal recommended phase two dose of O N 123.
The phase one study of <unk>.
Oh, and 123 in China and has enrolled three patients each.
Each with metastatic breast cancer.
And enrolled in the second dose cohort of 80 milligrams has begun.
We are pleased to report that Oh, and 123 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 her two negative breast cancer.
Since this indication is the one for which the established commercial for six inhibitors are approved.
We believe evidence of efficacy in the <unk>.
Metastatic breast cancer.
With an acceptable safety profile could be on most rapid path for.
For an approval.
And for the possibility to ultimately enter the first line setting in this indication.
For hats as a single agent.
Which would minimize issues with tolerance when the estrogen pathway is interfered with.
As is required for the commercially approved CDK four and six inhibitors when prescribed.
Due to the broader Chinese inhibitory spectrum of O N. One two or three 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 one studies and our interactions with the FDA.
To remind you Oh and 123 is a proprietary first in class multi kinase inhibitor, which distinguishes itself by targeting CDK for six and additional tyrosine kinase pathways involved.
And the proliferation of cancer cells.
On the metastatic potential of cancers as well.
We believe with this mechanism of action targeting CDK for six and additional kinases, such as Lyft split three and others.
Oh in 123 represents an innovative approach.
Treating solid tumors and hematological malignancies that are refractory or have become resistant to CDK for six inhibitors as well as tumor indications.
This class of drugs to date do not have regulatory approval.
Based on preclinical models.
Oh, and 123 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.
Oh and 123.
Our other pipeline compound <unk>.
Target pathways involved in neoplasia co.
Causes it to be cytotoxic to most of all tumor types in vitro.
The first description.
Average unique mechanism of action, where as described in the prestigious journal cell.
2016 for.
Adjusting regal sort of interfered with the mutated Ras pathway.
Subsequent published studies demonstrated that rigor assertive may function as they may.
Turbulent inhibitor.
As well as influencing the junk with J M K pathway.
And thereby suppression of the rate of Ras signaling.
We are supporting ongoing investigator.
Sponsored studies.
The oral formulation of rig assertive.
And on preparing to support several new studies exploring the use of oral rigo surrogate for cash is driven by mutations of the Ras genes.
Currently.
Phase one study in patients with.
With advanced K, Ras mutated non small cell lung cancer is being conducted with Regal surgery.
In combination with the PD, one inhibitor, Nevada map.
A drug provided for this study by Bristol Myers Squibb.
The study is open and continuing to enroll.
The study objectives.
Identify the recommended phase two dose of this novel doublet.
To characterize its safety profile.
The K Ras mutation.
As 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.
For new indications.
In our view.
This makes our novel combination approach with V go sure.
Potentially meaningful option to pursue in lung cancer and other disorders.
K Ras mutations manage 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 one non small cell lung cancer study.
<unk> and 2021.
In addition, an investigator initiated phase one day slash two study.
With oral rigo showed a mono therapy and advance rash.
<unk> squamous cell carcinoma is now open.
On another study based on data presented at the American Association of Cancer Research meeting in 2019.
It's under review in metastatic malignant melanoma for.
10 shillings in combination with Keytruda.
A preclinical study is also evaluating oral rigo sort of income.
Clear cell renal cancer.
Other than the cost of supply oil Regal circuit to the investigators on.
No that does not expect to incur significant expense.
For these investigator initiated studies.
We are still awaiting word on on.
Funding request 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.
Clinical trials with V go sort of 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 'twenty 'twenty financial results.
Mark.
Yes.
Thanks, Steve and good afternoon, everyone.
I'll start with a review of our 2020 expenses and then I'll discuss our cash position on cash runway.
Research and development expenses for 2020 were $16 9 million and.
And this compares with $15 $5 million for 2019.
The increase was primarily related to higher regulatory consulting expenses and manufacturing costs related to clinical supply of our on 123.
Partially offset by lower expenses for the oral <unk> 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 and the 2019 period we're on.
Offset by higher pre commercialization insurance and corporate legal and stockholder meeting expenses and the 2020 period.
Net loss for 2020 was $25 2 million or <unk> 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.
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 32020.
Proximately $3 7 million warrants have been exercised resulting in proceeds zero point $7 million.
As a result, our cash on cash equivalent 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.
We are very excited about our development plans for <unk> 123.
And all legal surgeon.
And believe we have a very strong financial position.
We urge our stock holders, 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.
Thank you, Steve Ladies and gentlemen, if you wish to register for a question for todays question and answer session. You will need to press Star then the number one on your telephone. If your question has been answered and your interest in the drag any question you may do so by pressing the pound.
If youre using a speakerphone please pick up your handset before entering any price when mcneese for quite a first question.
Our question comes from the line of Joe cleansing.
Sir. Please go ahead your line is open.
Great. Good afternoon. This is Matt Taylor on for Joe Thanks for taking a couple of questions.
First can you remind us of your cell lines resistant studies using <unk> three and the benefits that you saw.
Sure and thank you for that.
Steve coated <unk> who's on the phone did most of those studies, Steve would you like to take the question.
Sure. Thank you for a question on this.
This is Steve Cosenza.
I believe you're referring to the.
Resistant cell lines that are resistant to Pablo to Clinton and the cell lines resistant due to a deficiency in the RB pathway either by no means there on that.
Expressing rb.
Or are they are mutated in that pathway and therefore these graduate from that required.
For cell division the main target of the approved.
CDK <unk> inhibitors.
On tableau cyclic and rather sit glib on.
And to some extent Abbott on the cichlid require functional RB pathway for these compounds to be active in.
And in these tumor cells are compound since as a multi kinase inhibitor were found to these sales we were found to be.
Similarly sensitive to these two Oh on 123 went from three 300 S. RB for.
Sufficient sales.
Great. Thank you. So much appreciate it second question for you guys I know you've kind of mentioned that on the presentation, but can you provide any more detail on when you might think that we could see from the lung data.
For the gear Institute this.
This year.
So again, thank you for that question so.
You're asking about the combination lung cancer trial, K, Ras mutated lung cancer trial and advance our K Ras mutated patients.
So the.
Those are re go to surgery.
As already reached the highest level of rigor assertive that we've given in the current scheme in combination with full dose no role in that.
We will determine based on whether or not dose limiting toxicities are observed if we've already established the recommended phase two dose of the doublet.
If we have not.
In addition, no dose limiting toxicities, we may elect to continue to dose escalate.
Oh sure.
In either scenario, we anticipate having the recommended phase two dose of the dump that before the end of the year.
Great Fantastic also very helpful. On one more question before I, let you guys go offer related to timeline on when do you think you can see some data from the squamous cell carcinoma data on that's associated with our D E B patient.
Again, thank you for your question that's the more difficult question to answer. So these are very rare squamous cell cancers, because they are driven by genomic abnormalities a rash.
So these patients are few and far between and it is an international study in both Europe and the U S. But it's very hard and rare indications could determine when we will have the clinical data.
So I'm going to basically answer I do not know its 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.
Yeah totally makes sense. Thank you again for providing that input and thanks again for taking my question congratulations.
And so I'm showing no further questions in the queue at this time I'd like to turn the call back to Mr. Steve Fruchtman for any closing remarks.
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 patient enrollment in the second quarter of 2021.
For our U S phase one trial with O N 123, and advanced cancers.
Including metastatic breast cancer patients refractory to approved CDK for six inhibitors.
We expect to have the recommended phase two dose for 1123 by the first half of 'twenty 'twenty two.
Two.
The pipeline of investigators sponsored studies with oral rigo asserted is advancing.
And further progress as anticipated in 2021.
Crude establishing a dose for further study of the combination of oral rigo and the vote on that and K Ras mutated non small cell lung cancer and other solid tumor Ras driven cancers, but he end of the year.
Three.
We are actively evaluating strategic opportunities to enhance our product portfolio.
Given by science and the potential for clinical benefit for patients.
Hopefully before the end of the year.
For.
And again.
An important reminder.
Please take action today and vote for the proposals and the special meeting of stockholders.
We greatly appreciate your continued interest in the programs aren't going over.
Should you have any additional questions. Please feel free to contact us.
Thank you again stay safe and have a nice evening.
Yeah.
Ladies and gentlemen, thank you for your participation on today's conference call. This concludes today's event you may now disconnect.
Okay.
[laughter].
Yes.
Yeah.
Yeah.
Okay.
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Okay.
Okay.
[music].
Moving on.
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Okay.
Okay.
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Ladies and gentlemen, thank you for standing by well go on city uncle on Novartis Therapeutics 2020 financial results and business update conference call. At this time, all participants are in a listen only mode.
Moving managements prepared remarks, we will hold a question and answer session to ask a question at that time. Please press star followed by one on you touched on fun. If anyone has difficulty hearing the country. Please press star zero for operator assistance as a reminder, this call is being recorded today March 11th signing for anyone.
At this time I would like to turn the call over to Avi Oler Senior Vice President of corporate development and General counsel sorry for each thank you operator.
Afternoon, everyone and welcome to <unk> 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 on the investors and media section of our website at Ww.
W Docker Nova desktop.
On today's call Dr. Steve Brookman, 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 March report well move to the Q&A portion of the call and will be joined by Dr. Steve <unk>, our lead scientist before we begin I'd like to remind everyone that statements made during this conference call by management will include forward looking statements under the Safe Harbor provision of the best Private Securities Litigation Reform Act.
With 1995, which involve risks and uncertainties that could cause actual results to differ materially forward looking statements speak only as of the day there.
The underlying facts and circumstances may change, except as required by law.
Disclaims any obligation to update these forward looking statements to reflect future information expense 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.
It is now my pleasure to turn the call over to Steve.
Thank you Avi.
Afternoon, everyone.
Thank you for joining us.
We continue to hope you your colleagues and your loved ones.
Safe and healthy.
We are living an amazing times.
Missing the power of nature.
And the dramatic influence key scientific discoveries.
To help you mankind.
Truly extraordinary year.
Right.
The progress to enter the clinic.
And.
And advancing our multi kinase inhibitor oh.
Oh, and one to three 300, which I will refer to as Oh and 123.
I want to thank our stockholders for your tremendous support.
Well aren't you know over the years.
I also want to ask for our stockholders of record as.
As of January 12.
That have not yet voted to vote today and on.
I didn't know this stockholders' meeting.
The board of directors for.
<unk> believes that the stock.
Colder proposals to change our capital structure by a reverse stock split.
And the best.
Interest of stockholders.
Turning out the vote is imperative for the.
The company to execute its just tease you plan from a strengthened position.
We believe the approval.
These proposals well what.
Sure.
We maintain our NASDAQ listing.
Two.
Higher stock price.
It increased the company's appeal.
Permit institutional and fundamental biotech investors to invest in on can know.
And three.
In licensing programs under evaluation.
We believe approval of the proposals.
We 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.
Please vote today.
At the March for a special meeting.
Which was a journey through April 1st.
More than 70 per cent of the shares which had voted voted in favor of two proposals one.
For a reverse stock split and two.
So on a decrease in the number of our authorized shares.
However.
We did not meet the required threshold.
For approval of more than 50 per cent.
The outstanding shares.
For the two proposals.
In addition to the support of our stockholders who voted on.
All three independent proxy advisory firms.
I I S S glass.
Cash Lewis and Egan Jones.
Recommends its stockholders vote for the proposals.
Their support.
Based on their view.
That a yes vote is in the best interest of stockholders.
The stockholder meeting process, there's also cost to the company and to you.
If any stockholders of record have now voted.
We urge you to please do so today.
The need for additional meetings.
If you voted for.
Against the proposals.
Please reconsider your vote.
Reach out to speak with any member of management or our proxy solicitor.
Kenzie partners, if you have any questions regarding the proposal.
Or email us at ladder.
There are add on.
<unk> got U S.
We announced that we will make a $50000 donation to the American cancer Society.
We can achieve 70% or more voting participation by stockholders of record on January 12th regardless of how the stockholder vote.
As our focus is on study cancer indications with our novel compounds, we believe.
Supporting the important work of the American Cancer Society.
Thank our shareholders for voting.
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.
With our lead product <unk>.
In 123.
For fourth quarter of 2020 and.
In recent weeks have been very active and productive as we continued preparations to advance Oh and 123 into the clinic.
In the United States.
We submitted an investigational new drug application to the SGA for.
A phase one study in advanced cancers, including hormone receptor positive her two negative metastatic breast cancer patients refractory or resistant to health authority approved CDK for six.
<unk> in.
In December of 'twenty 'twenty, we received clearance from the FDA to begin the phase one study and have since received institutional.
Review Board for IRB approval at our first site.
We expect that the first patient will be enrolled in this study some time during the second quarter of this year.
Two additional sites are in the study setup process.
With three phase where on sites.
We will be able to expedite that timeline to the important milestones.
Establishing a recommended phase two dose.
We anticipate three.
Phase one site in the U S in conjunction with the Phase one trial being conducted with all in 123 in China will establish the recommended phase III optimal dose.
Studying.
Different cancer indications.
Over express the tyrosine kinase targeted boy, Oh, and 123 in addition to CDK four and six.
These phase one studies will assess the safety.
Tolerability and pharmacokinetics of O N 123 administered orally at increasing doses.
Siding at 40 milligrams daily.
Tenuously for 28 day in the U S study.
For three out of four weeks in this study in China.
These two different administrations schemes mimic different administrations schemes used for three FDA approved CDK four and six inhibitors.
And we believe will support finding the optimal recommended phase II dose of <unk> 123.
The phase one study of.
Oh and 123 in China.
Wrote three patients each with metastatic breast cancer.
And enrollment in the second dose cohort of <unk>.
80 milligrams has begun.
We are pleased to report that Oh, and 123 appears to be well tolerated thus far.
As no dose limiting toxicities have been seen to date.
Okay.
We are most interested in.
Studying patients with refractory hormone receptor positive <unk> negative breast cancer.
Since this indication.
Is the one for which the established commercial for six inhibitors are approved.
We believe evidence of.
Africa is.
For metastatic breast cancer.
Along with an acceptable safety profile could be on.
Most rapid path for an approval for.
The possibility to ultimately enter the first line setting in this indication for.
Perhaps as a single agent.
Which would minimize issues with tolerance when the estrogen pathway is free.
Good work.
As is required for the commercially approved CDK four and six inhibitors when prescribed.
Due to the broader Chinese inhibitory spectrum of Oh, and one to three it has the potential for efficacy and <unk>.
Additional tumor indications as well.
We will share with you our developmental plans following the completion.
The phase one studies and our interactions with the FDA.
To remind you all in 123 is a proprietary first in class multi kinase inhibitor.
Which distinguishes itself by targeting CDK for six and additional tyrosine kinase pathways.
Cloud and the proliferation of cancer cells, and the metastatic potential of cancers as well.
We believe with this mechanism of action targeting CDK for six and additional kinase such as Lyft, let three and others.
Oh, and 123 represents an innovative approach to <unk>.
Treating solid tumors and Hematological malignancies data refractory for have become resistant to CDK for six inhibitors as well as tumor indications, where this class of drugs to date do not have regulatory approval.
<unk>.
Based on pre clinical models.
And 123 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 over and want to trade.
On the pipeline compound <unk>.
Target pathways involved in neoplasia.
Causes it to be cytotoxic to most of both tumor types in vitro.
The first description.
Average unique mechanism of action, where as described in the prestigious journal cell.
2016.
Suggesting regal assertive interfered with the mutated Ras pathway.
Subsequent published studies demonstrated that Rieger Acervative may function as a microtubule inhibitor.
As well as influencing the junk with J K pathway.
Thereby suppression.
On the right of Ras signaling.
We are supporting ongoing.
Investigator.
<unk> studies with the oral formulation of rig assertive.
And are preparing to support several new studies exploring the use of oral rigo surrogate for.
Cash is driven by mutations of the Ras genes.
Currently.
Phase one study in patients.
With advanced K, Ras mutated non small cell lung cancer is being conducted with Regal surgery.
In combination with the PD, one inhibitor Navona map.
A drug provided for this study by Bristol Myers Squibb.
The study is open and continuing to enroll.
The study objectives.
Identify the recommended phase two dose of this novel doublet.
To characterize its safety profile.
The K Ras mutation is a predominant genetic driver of non small cell lung cancer.
Given their utility in multiple cancer settings share.
Point 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 V go sure.
Potentially meaningful option to pursue in lung cancer and other disorders with K Ras 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 one non small cell lung cancer study are expected in 2021.
In addition.
And the investigator initiated phase one day slash two study.
With oral rigo third of mono therapy and advance Ras.
Tainted squamous cell carcinoma is now open.
On another study based on data presented at the American Association of Cancer Research meeting in 2019.
It's under review in metastatic malignant melanoma for.
10 shillings in combination with Keytruda.
A preclinical study is also evaluating oral rigo service income.
Clear cell renal cancer.
Other than the cost of supply oil vigorous Serbia to the investigators on.
No. It does not expect to incur significant expenses for these investigator initiated studies.
We are still awaiting word on our funding requests.
The National Institute of allergy and infectious diseases.
And the biomedical advanced research and development Authority also known as BARDA for.
For the possible funding.
Clinical trials with V go sort of in patients with COVID-19 disease in.
In the interim.
Preclinical work is ongoing.
And now I will.
Turn the call over to Mark for a discussion of our 'twenty 'twenty financial results.
Mark.
Yes.
Thanks, Steve and good afternoon, everyone.
I will start with a review of our 2020 expenses and then I'll discuss our cash position on cash runway.
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 clinical supply of all on 123.
Partially offset by lower expenses for the oral <unk> 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 and the 2019 period we're on.
Offset by higher pre commercialization insurance and corporate legal and stockholder meeting expenses and the 2020 period.
Net loss for 2020 was $25 $2 million or <unk> 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.
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.
$35 2 million from two equity offerings with institutional investors.
Since September 32020.
Proximately $3 7 million warrants have been exercised resulting in proceeds zero point $7 million.
As a result, our cash on cash equivalent 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.
We are very excited about our development plans for <unk> and 123.
And all legal asserting and believe we have a very strong financial position.
We urge our stock holders, 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.
Thank you, Steve Ladies and gentlemen, if you wish to register for a question for todays 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 for the dry area.
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Seeing a speakerphone please pick up your handset before entering any question one moment quite a first question.
Our question comes from the line of Joe cleansing.
Sir. Please go ahead your line is open.
Great. Good afternoon. This is Matt color on for Joel Thanks for taking a couple of our question.
First can you remind us of you saw on resistant studies using <unk> three and the benefits that you saw.
Sure and thank you for that.
Steve could it downstream.
He was on the flow. This most of those studies, Steve would you like to take the question.
Sure. Thank you for that question Steve.
Steve Cosenza.
I believe you're referring to the.
Resistant cell lines that are resistant to Paolo cyclic and these cell lines resistant due to a deficiency in the RB pathway either by no means theyre not.
Expressing rb.
Or are they are mutated in that pathway and therefore these graduate from that required for.
For cell division the main target of the approved.
CDK <unk> inhibitors.
Tableau cyclic and wireless the glib on.
And to some extent Abbott on the cichlid require a function of RB pathway for these compounds to be active in.
And these tumor cells are.
Compound since as a multi kinase inhibitor or found to the sales that were found to be similarly sensitive to these two oh on 123 123 300.
RB for.
Proficient sales.
Great. Thank you. So much appreciate it second question for you guys I know you've kind of mentioned this in the presentation, but can you provide any more detail on when you might think that we could see from the lung data.
Again this year.
So again, thank you for that question so.
You're asking about the combination lung cancer trial, K, Ras mutated lung cancer trial and advance our K Ras mutated patients.
So the <unk>.
Those are re go to surgery.
We already reached the highest level of rigor assertive that we've given in the current scheme in combination with full dose <unk> role in that.
We will determine based on whether or not dose limiting toxicities are observed.
We've already established the recommended phase two dose of the doublet.
We have not.
In addition, no dose limiting toxicities, we may elect to continue to dose escalate we go through it in.
In either scenario, we anticipate having the recommended phase II dose of the dove that before the end of the year.
Great Fantastic also very helpful. One more question before I. Let you guys go also related to timeline on when do you think you can see from data from the squamous cell carcinoma data that's the <unk>.
<unk> added with our D E B patient.
Again. Thank you for your question that's a difficult question to answer. So these are very rare squamous cell cancers.
They are driven by genomic abnormalities of rash.
So these patients are few and far between.
It is an international study in both Europe, and the U S. But it is very hard and rare indications could determine when we will have the clinical data.
So I'm going to basically answer I do not know its 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.
Yeah totally makes sense. Thank you again for providing that input and thanks again for taking my question congratulations.
And so I am showing no further questions in the queue at this time I'd like to turn the call back to Mr. Steve Fruchtman for any closing remarks.
Well. Thank you all for participating on today's update call.
To reiterate we have several near term milestones.
<unk> drivers ahead of us.
The first week.
We plan to commence patient patient enrollment in the second quarter of 2021 for.
For a U S phase one trial with all in 123 and advanced cancers.
Including metastatic breast cancer patients refractory to approved CDK four six inhibitors.
We expect to have the recommended phase II dose for all in one to three by the first half of 'twenty 'twenty two.
Two.
The pipeline of investigators sponsored studies with oral rigo asserted is advancing.
And further progress as anticipated in 2021.
Including establishing a dose for further study of the combination of oral rigo and of all the math and K Ras 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.
By Science.
And the potential for clinical benefit for patients.
Hopefully before the end of the year.
For.
And again as an important reminder, please.
Please take action today and both for the proposals and the special meeting of stockholders.
We greatly appreciate your continued interest in the programs aren't going over.
Should you have any additional questions. Please feel free to contact us.
Thank you again stay safe and have a nice evening.
Ladies and gentlemen, thank you for your participation on today's conference call. This concludes today's event you may now disconnect.