Q2 2021 PDS Biotechnology Corp Earnings Call
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Greetings and welcome to P. D S Biotechnologies second quarter 'twenty 'twenty, one financial results.
At this time all participants are in a listen only mode.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
As a reminder, this conference is being recorded.
I would now like to turn the conference over to your host Deanne Randolph Vice President of commercial development. Please go ahead.
Good morning, and welcome to PBF Biotechnologies second quarter 2021 earnings conference call and audio webcast.
Today, our doctor, Thank Betty I'm, Chief Executive Officer, Dr. <unk> <unk>.
Chief Medical Officer and Dr. Jeffs.
<unk> Chief Financial Officer.
Earlier this morning, Pdfs biotech issued a press release announcing financial results for the quarter ended June 32021.
Cause everyone to read the press release as well as PDF by our quarterly report on form 10-Q, which was filed with the SEC earlier this morning.
The company's press release is available on <unk> website at <unk> Dot Com and the quarterly report will be posted later call.
In addition, this conference call is being webcast through the company.
Website and will be archived there for future reference.
Before we begin I would like to caution listeners that comments made by management. During this conference call will include forward looking statements within the meaning of federal securities laws, including the Safe Harbor provisions of the private Securities Litigation Reform Act of 1995.
These forward looking statements involve material risks and uncertainties and the company's actual results may differ materially.
For a discussion of these risk factors, including among others statements related to Covid 19 impacts the pandemic may have on the company's business operations and internal operations and results of operation and the company's ability to respond to the related challenges, including those noted in this morning's press release, please refer to PDF biotechs.
Our SEC filings.
Investors potential investors and other listeners are urged to consider these factors carefully in evaluating the forward looking statements and are cautioned not to place undue reliance on such forward looking statements.
Please note that the contents of this conference call contains time sensitive information that is accurate only as of the data for Lifelock have August 12.2021.
Except as required by law the company undertakes no obligation to revise or update any statements to reflect events or circumstances that take place. After the date of this call.
Following today's prepared remarks, we will open the discussion for a question and answer session with that I would now like to turn the call over to Dr. Frank study of Baader Bank.
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Mr Better Adam your line is live.
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Let me start again that.
Thank you, Dan and thanks to everyone on the call today.
In the first half of 2021.
P. J S. Biotech took a very significant step forward in our quest to develop transformative treatments for cancer.
Over the past quarter, we obtained initial efficacy data in advanced refractory cancer patients, whose cancer has continued to progress after treatment.
And these advanced cancer patients the observation of tumor shrinkage and about 70% of patients.
The jets that P. D S O 100 one's ability to induce in vivo.
Large quantities of the Reits phenotype of HPV 16 specific killer T cells with strong, killing potency may provide a powerful anti tumor effect.
This observation based on agreements with extensive preclinical studies as well as our phase one clinical study of <unk> 101.
We will continue to evaluate and confirm the anticancer efficacy of burst immune in our three ongoing phase II trials of our lead candidate <unk> hundred one in HPV related cancers.
The demonstration of strong efficacy in preclinical and clinical studies of <unk> or <unk>.
Provides the scientific and clinical basis to aggressively pursue the next phase of growth for the company.
We are preparing to advance our next two oncology pipeline products into human clinical testing, which both Loren and I will discuss in more detail.
Our recently completed financing provides us with the capital backing necessary to accomplish our plan of expanding our pipeline into clinical testing.
These planned activities will enable us to continue to validate the <unk> platform as a highly promising approach to safe and effective cancer immunotherapy.
We anticipate that the current data will also facilitate our path towards commercialization of our products and our plans to continue to grow shareholder value.
The interim data for our National Cancer Institute led Phase II study of <unk> hundred one was reported on schedule as projected during the second quarter.
Let's begin by reviewing this interim data, which was presented by the National Cancer Institute at the American Society of clinical oncology annual meeting.
<unk> <unk> hundred one is being developed to treat cancers caused by HPV type 16, including anal cervical head and neck P&L vaginal involved with cancers.
In the United States, approximately 43000 patients are diagnosed with HPV related cancer annually.
The vast majority of advanced HPV cancers about 70% to 80% of these cases are caused by HPV 16.
For HPV cancer patients. The first line of therapy, it's usually radiation treatment with all followed by chemotherapy is necessary.
It is reported that after 30% or more of these patients will either fail treatment and progress to metastatic disease or have a recurrence of the cancer.
These refractory patients who failed treatment with chemotherapy and radiation, but who have not been treated with checkpoint inhibitors and are therefore checkpoint inhibitor naive constitute the first group of patients evaluated in the trial.
It should be noted that checkpoint inhibitors have been FDA approved to treat these patients with refractory HPV cancer.
About 12% to 24% of these patients depending on their report respond to checkpoint inhibitor therapy, meaning back 80% or more of these patients.
We will not respond to checkpoint inhibitor therapy.
This group of checkpoint inhibitor refractory patients constitutes the second group of patients being evaluated in the trial.
These particular patients have very few options available to them and the historical median survival of only three to four months.
P. S O. One O. One is specifically designed to treat HPV 16, which as I mentioned is the most difficult to treat type of HPV cancer.
Based on the patient population and their stage of illness.
With potentially weekly functional immune system.
Very short survival times, we have set an extremely high bar for Pds or 101.
We believe that this is important to clearly understand and to demonstrate the potential of the virtual platform to significantly advance the treatment of cancer.
In this trial <unk> hundred one is being evaluated in a triple combination, including two other clinical stage immunotherapies.
Ben trucks stuff Alpha a bifunctional checkpoint inhibitor TGF beta trap fusion protein and M 90, 241 on immune cytokines.
<unk> <unk> hundred one is designed to activate the immune system to produce in vivo large quantities of powerful <unk> positive killer T cells to target and kill tumors that are HPV 16 positive.
This novel combination is being studied in patients with all types of advanced HPV associated cancers, whose cancer has returned all spread after treatment.
At the time of interim data reporting it was found that after the initial six HPV 16 positive patients who had not been treated with checkpoint inhibitors, the checkpoint inhibitor naive patients.
Five out of six or eight 3% demonstrated an objective response with a tumor reduction of 30% or more.
We haven't yet reported objective response rate in this population with current standard of care checkpoint inhibitor treatments ranges from 12% to 24%.
Of the patients treated with a P. D. S O. One O one based triple combination, 100% were still alive at eight months.
Historical median survival.
Historical median survival or lifespan for this patient population is seven to 11 months.
Now off the 12, HPV 16 positive checkpoint inhibitor refractory patients who had also failed treatment with checkpoint inhibitors. In addition to chemotherapy and radiation treatment.
Tumor reduction was observed in seven out of 12 or 58% with an overall objective response rate of 42% already achieved at the time of reporting.
The objective response rate with the current standard of care ranges from 5% to 12%.
83% of patients treated with a PD L 101 based combination were still alive at a median of eight months.
In contrast, the historical median survival or lifespan for this patient population is only three to four months.
It is important to understand that <unk> hundred one is designed to train the body to generate killer T cells.
<unk>, specifically targets HPV 16.
This means that for the 20% or so whose cancers are caused by a different type of HPV.
The HPV 16 specific T cells generated by Pdf's <unk> hundred one may not recognize their cancers.
It was interesting to note in the <unk> presentation that seven patients were recruited whose cancer was HPV 16 negative.
Meaning that their cancer was caused by a different type of HPV HPV.
HPV 16.
The seven patients received the triple combination.
And it was reported that none of these patients experienced tumor reduction.
Compared to almost 70% of HPV 16 positive patients who experienced tumor reduction.
These results highlight the potential role of Pdf's <unk> hundred one and specifically recruiting.
Training and army large numbers of cancer attacking HPV 16 killer T cells in these very ill patients.
These killer T cells are critical to generating an effective anti cancer therapy.
As I mentioned at the beginning we have set a really high bar for <unk> hundred one our first proof of concept study.
This objective response rates are unprecedented in immuno oncology.
Strengthening the evidence of the <unk> platform's potential ability to induce high levels of tumor specific CD eight plus killer T cells, but may attack, the cancer and overcome a key limitation.
Cancer immunotherapy.
The data suggests that diverse immune based immunotherapies may have the potential that the standard.
Okay.
May have the potential to set the standard by which other oncology products and immuno oncology products will be compared.
Moving on now to the Pts biotech initiated a versatile zero-zero two trial.
The versatile 002 study is designed to evaluate <unk> hundred one in combination with Keytruda also known as <unk> in the treatment of advanced HPV 16 associated head and neck cancer.
The trial is currently being run at approximately 16 clinical sites in the United States.
With an eventual target of 26 sites.
Keytruda is FDA approved for the treatment of head and neck cancer, including HPV associated head and neck cancer.
It is reported that about 70% of cancers of the Ara phonics may be linked to HPV and about 90% of these are HPV 16 positive.
This highlights the need for effective therapies to address advanced HPV associated head and neck cancer.
Given the impressive interim results seen in the National Cancer Institute led study.
And the strong suggestions of effective HPV specific T cell induction.
Even in patients who had failed checkpoint inhibitor therapy, we have expanded the breadth of towels zero-zero. Two trial to also include checkpoint inhibitor refractory patients.
As previously reported.
The other arm is evaluating the combination as first line therapy for recurrent or metastatic head and neck cancer and checkpoint naive patients.
We believe there is a significant unmet medical need in advanced refractory head and neck cancer.
The combination of PD is a 101 and keytruda has the potential to significantly improve clinical outcomes for these patients who have limited treatment options.
We still anticipate that preliminary data will be available on schedule.
We have been projecting late in the fourth quarter of 2021 or during the first quarter of 2022.
Moving onto the third trial the immunotherapy trial.
The MD Anderson, let immunotherapy trial is a phase II study evaluating <unk> hundred one in combination with standard of care chemo radiotherapy or CRT.
For the treatment of locally advanced cervical cancer.
The study is investigating the safety and preliminary efficacy outcomes of this combination.
The single site study is actively recruiting and enrolling patients.
Based on the reported impact of Covid 19 on clinical operations at MD Anderson.
We believe that it is extremely unlikely for preliminary clinical data to become available during the fourth quarter of 2021.
Our most recent projections due to the uncertainty regarding recruitment rates at MD Anderson, where for the fourth quarter of 2021 through the first half of 2022.
We now believe preliminary results will most likely be available when UNICEF during the first half of 2022.
As we reviewed during our recent research and development day.
The interim data from these Pds or 101 studies provides early clinical proof of concept data that allows us to confidently advance our next two oncology pipeline products into human clinical trials.
P. S O one O two combined diverse mean platform technology.
With the proprietary T cell receptor gamma alternate reading frame protein.
A RFP also known as TARP.
Tumor antigen identified by the National Cancer Institute.
With tumor specific protein is strongly associated with acute myeloid leukemia, AML prostate and breast cancers.
Approximately half a million patients are projected to be diagnosed with AML prostate or breast cancer. This year in the United States alone.
Most of these cancers will be associated with top.
It is important to note that.
Is it.
It is important to note that talk is a clinically validated target.
That is performed and published by the National Cancer Institute in prostate cancer patients showed strong immunogenicity and significant slowing of the cancer growth rate.
MPT is a one or two preclinical studies conducted by Pds biotech we have demonstrated the ability of <unk> to significantly enhance the in vivo induction of powerful TARP specific CD eight killer T cells.
The majority of the formulation and preclinical work for periods of one or two has been completed and our goal is to initiate a phase one two clinical trial in the first half of 2022.
We announced last quarter.
Dr. Mark Frohlich, a world renowned experts in prostate cancer and immunotherapy has joined the Pds biotech scientific Advisory Board.
It is also important to note that Pds biotech already has the world's foremost experts in TARP immunotherapy, Dr. Laurent <unk>, our meeting our clinical programs.
Sirius or one off III combines diversity and platform technology with novel highly immunogenic agonist epitopes of Mach one.
Mark <unk> is highly expressed in multiple tumor types and has been shown to be associated with drug resistance and for disease prognosis.
Eds biotech is developing <unk>, a one or three for the treatment of breast colorectal lung and ovarian cancers.
In the United States alone approximately 690000 patients are diagnosed with these types of cancer annually.
Preclinical work for Pds are one of three is ongoing both at <unk> and at the National Cancer Institute.
We expect that the results of those studies will be available by the end of this year and will inform the phase one two clinical trial design.
As with Pdfs of one or two although with PD <unk> three is to initiate a clinical trial in 2022.
Last quarter, Pts biotech announced the addition of Dr. Oliver <unk>, a world renowned immunotherapy experts and the discoverer of the Mach one protein to the Pds biotech scientific Advisory Board.
IPD is biotech our primary focus continues to be oncology.
However.
Based on the previously described potential to develop a new class of T cell and new things vaccine using our <unk> platform.
Our partners are making progress with our infectious disease candidates as well.
P S O to O two.
Is being developed as a universal flu vaccine capable of providing protection against multiple strains of the flu virus.
P S O to O two combined diverse new platform with novel influenza proteins.
Preclinical work for <unk> O to O. Two was initiated a few months ago in collaboration with our partner Professor Gerald Woodward at the University of Kentucky School of Medicine.
The work has been progressing steadily in collaboration with researchers at the NIH Civics program. According to the projected schedule.
The initial results have been highly encouraging and.
And we still anticipate the preclinical work will be completed during the fourth quarter.
P. S O to O. Three was designed with the goal to potentially provide long term and broad protection against infection from Covid 19.
Pharma call Biotechnology has license diverse immune in Latin America to develop Pds, Oh, two or three in Brazil.
P S O to O three consists of two components.
Vers immune which is being produced by Tds biotech.
And the Sars Covid, two <unk> being developed.
Which is being developed and manufactured by Pharmacopeia.
In addition to manufacturing the antigen pharma cold leads all regulatory and clinical trial efforts in Brazil.
As of today Pharma court has not yet completed manufacturing of the antigen in order to submit the full chemistry manufacturing and controls or CMC portion of the investigational medicine product dossier, MPV two and visa.
This is required to complete NV, such a review of the program.
As a result this program has not progressed as expected by Pds biotech and we will be completing a full program review to determine next steps.
Moving on to financials.
This June we completed a $52 million public offering.
Seth Van Voorhees, Pds biotech CFO will provide further detail on the financing.
Pts biotech has built significant momentum over the past three months as evidenced in our recent addition to the Russell Microcap index as part of the 2021 annual reconstitution.
We plan to build on that momentum to execute efficiently to develop a new generation of cancer Immunotherapies and to continue to grow shareholder value.
Now I'd like to pass the call to Dr. Lauren Wood, Pds biotechnology as Chief Medical Officer.
Who will provide more comprehensive clinical updates on our immuno oncology programs Lauren.
Yeah.
Thank you Frank and thanks to all of you for joining us this morning.
Brian just detailed we have made incredible progress with our oncology pipeline since our first quarter call.
I'll begin with our ongoing oncology clinical trials.
Starting with our lead candidate Pds, a one O one which targets HPV 16 related cancers. There are three ongoing phase III clinical trials.
The most progressed is a study being performed at National Cancer Institute in advanced HPV associated cancers.
Interim data for this study was presented in June at the 2021, Astro meeting as Frank mentioned these Pds a one on one data represents the first proof of concept human clinical data in advanced cancer for Arbor's immune technology platform.
Again with an overview of the clinical trial design for this investigator initiated study.
<unk> <unk> hundred one in combination with interest is alpha also known as M..70, 824, a first in class bifunctional checkpoint inhibitor.
And $92.41.
An antibody conjugated cytokine designed to facilitate entry of the cytokine IL 12 into tumors.
Moving forward our further debt.
Alpha is dangerous.
The study is designed to evaluate the treatment combination in both checkpoint inhibitor naive.
And refractory patients with advanced HPV associated cancers that have progressed or return after treatment.
Most HPV associated cancers.
Associated with greater than 95% of all use cases are represented in this MTI dataset.
Academia LNG reports, we know that 70% to 80% of these cancers caused by HPV 16 infection as Frank noted the most oncogenic high risk HPV types.
These cancers, including AML cervical head and neck, vulvar and vaginal cancer.
The composition of tumor types inclusion in the trial to date is similar to that seen in the overall population with the majority of patients having had a neck or cervical cancer, followed by Angel vaginal and Barbara cancers.
In the trial objective response rate known as O R. R.
Goodbye radiographic tumor responses according to resist one one.
The study will ultimately evaluate the objective response rate in 56 patients.
Today, We will review an interim look at the data presented that includes a total of 25 patients approximately half the patients to be accrued to the study.
The study enrolled a challenging and difficult patient population to treat.
Of the 25 patients evaluated this dataset.
96% had failed chemotherapy and radiation treatment.
And 56% had also failed checkpoint inhibitor therapy.
Patients also often come to the National Cancer Institute.
Maryland, when they have exhausted all other standard of care treatment options and you can see that reflected in these demographic data.
Importantly of the 25 patients 18, where HPV 16 positive and seven where HPV 16 negative.
Ali 18, HPV 16 positive patient six which I pointed inhibitor naive and 12 with checkpoint inhibitor refractory.
Median study follow up representing was about eight months.
Let's begin with the six HPV 16 positive checkpoint inhibitor naive patient.
Again objective response is defined by resist one one as a reduction in tumor burden of at least 30% or more.
And these patients who had not previously received checkpoint inhibitors. The triple combination achieved an 83% objective response rate.
This is an outstanding result, thus far and exceeds expectation as this patient population is very difficult to treat because they are so heavily pretreated.
The objective response rates with standard of care checkpoint inhibitors reports date H.
HPV cancer patients, who have failed prior therapy is generally around 12% to 24% of.
Of the five objectives responses in this population one patient had already achieved a complete response.
Importantly, this triple combination also shows promising durability in these HPV 16 positive checkpoint inhibitor patients as 80% of these patients have an ongoing response at a median of eight months of follow up on all six patients are alive.
Patients came off the combination haltingly response.
For context. This patient population has a historical mean survival of seven to 11 months with standard of care checkpoint inhibitor therapy.
These preliminary interim results suggest that Pds are one on one injection of in vivo highly active tumor tacky HPV 16 killer CD eight T cells documented in the published preclinical animal studies May also result in effective tumor shrinkage in humans.
Yes.
Moving out to the 12, HPV 16 positive patients treated any checkpoint inhibitor refractory arm nishu.
And these are patients who have failed treatment with chemotherapy radiation therapy as well as checkpoint inhibitors. In this population the triple combination achieved tumor reduction and 58% of patients.
These 12 patients, including the initial eight patients reported in the abstract where pfizer age or 63% tumor reduction.
Of the four additional patients in this updated dataset.
Two patients already had ongoing tumor reduction at the time of reporting.
Not yet not to 30% or greater threshold criteria for objective response.
As might be expected with standard of care. The objective response rates reported in checkpoint refractory advanced HPV cancer patients are even lower than those naive to checkpoint inhibitors generally only 5% to 12%.
Encouragingly similar to the checkpoint inhibitor naive patients.
The Triple combination also showed potential promising durability in these HPV 16 positive checkpoint refractory patients.
58% of patients have ongoing tumor reduction.
And importantly, 80% of patients who had achieved an objective response had ongoing responses at a median of eight months.
That 10 of 12, 83% of these patients are alive at a median of eight months is also notable.
Again this checkpoint refractory patient population generally has historical median survival of less than half that only three to four months.
These preliminary results suggest Pds all went online induction in vivo.
Active tumor attacking HPV 16 killer CDA T cells, even in extensively treated unlikely immunologically limited patient presents strong potential for effective disease reduction.
And unprecedented durable responses.
As with any other combination regimen, a common question that arises if the relative contribution of individual components in the triple combination to the encouraging results so far.
Typically the top question posed to doctors trials following this presentation.
Do you believe all three therapies are contributing to the clinical benefit.
The data on HPV 16 negative patient health to elucidate the role of PD S N Y O y and the Triple combination.
Youll recall that this trial is being conducted in patients with advanced HPV related cancers.
I'll stick on the strain of H P D required to qualify for enrollment.
It's important to understand that P. D. S O. One O. One is actually a molecularly targeted immuno therapeutic.
Leverages the specificity of the immune system to just diligently and exclusively attack tumors expressing only the target tumor antigens, which in this case increased HPV 16 E six and seven.
Among the checkpoint inhibitor naive and refractory patients in the study 67% of HPV 16 positive patients experienced tumor reduction at a median of eight months.
In contrast in the seven HPV 16 negative patients.
Those with an HPV type other than HPV 16 that do not express the molecular target PDL one.
Zero.
Seven patients experienced tumor reduction.
These observations suggest that HPV 16 specific C H.
And even CD four T cell induction by Pdfs on one on one as predicted by the preclinical studies may promote tumor reduction.
Hans clinical benefit of the Triple combination.
Results from these seven HPV 16 negative patients also suggest a potential critical role of pdfs on one on one induced CDA T cell in promoting survival.
In the Triple combination treatment.
And these heavily treated advanced cancer patients remarkably the majority of patients are still alive at a median of eight months of follow up.
89% of the HPV 16 positive patients are alive.
57% of the HPV 16 negative patients are also alive.
These preliminary data are particularly encouraging as they document impressive survival responses, regardless of prior checkpoint inhibitor exposure.
Furthermore, these clinical responses, we're seeing equally in all types of HPV 16 positive cancel in patients with cervical head and neck anal vaginal hasbro's Bolivar cancers.
It is very important because what it suggests is that it.
It may not matter, where in the body of the tumor is so long as it express the tumor antigen that is combined with first you need and which first and you train the T cells of the immune system to specifically recognize.
It's also has strong implications for effective treatment.
As well as elimination of metastatic disease.
Turning now to the safety data associated with the trial.
A very important consideration for combination oncology treatment regimen is to avoid additional or excess toxicity associated with limited anti tumor activity.
Importantly, P D F. One O one does not appear to compile toxicity other triple combination therapy.
The adverse events documented to date with a triple combination.
Consistent with those previously observed with intra and N 90, 241 mono therapy treatment.
Specifically grade three treatment related adverse events occurred and approximately 40% of patients.
The most frequent treatment related adverse events also known as T. R E where anemia due to gross hematuria decreased lymphocyte and the presence of flu like symptoms.
I just would be expected with both P. D F. A y O y and empty and $92.41 being delivered subcutaneously injection site reactions were seen in 20% of patients.
For patients, who originally had grade three toxicity with the triple combination, including N 90, 241, dosed at $16 eight micrograms per kilogram Todd.
Tolerated combination when the dose of N 90, 241 was lowered.
By 50% to eight micrograms per kilogram without any further grade greater than or equal to <unk> grade three toxicity.
Again, as we seek to understand the contribution of each of the individual components to the safety as well as the efficacy profile of the Triple combination. It's important to note that no new or worsening toxicities were observed from the addition of PDL one on one to the.
A combination.
We look forward to the data from the continued evaluation of these patients as well as the addition of more patients to the dataset to answer a very important questions regarding safety as well as clinical outcomes.
Now onto the PDF sponsored versatile heroes Europe two study.
As Frank discussed during his remarks activation of sites and enrollment and versatile Jersey or two continues to progress and we currently have 16 sites open to enrollment.
The versatile here or there are two trial was also recently expanded to include checkpoint inhibitor refractory patients.
As a result of the impressive preliminary results observed in this population in the NCI led Triple combination study I just talked about.
As part of their revised Simon two stage design objective responses. After six months of treatment will be assessed in both the checkpoint naive and refractory patient arms.
There is a leading cohort of 12 patients to assess the safety of the combination.
The total number of patients patients is essentially unchanged at 95, when you revised your buy.
We estimate safety data on the initial 12 subjects to be available in the coming months and anticipate preliminary efficacy data late in Q4 of 2021 or Q1 of 2022.
The study lead principal investigator is Dr. Jared Weiss, who serves as a section chief of thoracic and head and neck oncology at the University of North Carolina School of Medicine, Leinberger comprehensive cancer care Center, we are thrilled to have Dr. Wife's involved in this important study.
As with the NCI trial, there is an enormous unmet medical need in advanced head and neck cancer patients, who have failed multiple therapies, including chemotherapy radiation and checkpoint inhibitor therapy. We believe the combination of PD L 101, and Keytruda has the potential to similar.
Not only significantly improve clinical outcomes for these patients who have limited treatment options.
Moving now to the M. D. Anderson last phase II clinical trial P. D. F. O 101 in combination with standard of care chemo radiotherapy for the treatment of locally advanced cervical cancer.
This study is also known as immunotherapy.
It will enroll approximately 35 patients and investigate the effect of the combination on safety and preliminary oncologic outcomes.
Importantly, this study is also exploring immune timing by P. S O. One O one by studying various biomarkers of immune response in both blood.
And tumor tissue.
We believe the P. D. S O one on one's demonstrated ability to activate the immune system and induce tumor targeting killer T cells may provide improved outcomes to patients with cervical cancer.
First readout of clinical data from this study is anticipated during the second half of 2021.
The study is being conducted by Doctor and Carl M. D Ph D Associate professor of radiation oncology at the MD Anderson Cancer Center.
Frank mentioned this is a single site study and it has been heavily impacted by the ongoing Covid pandemic. We will continue to work closely with the excellent team of MD Anderson to monitor ongoing recruitment.
As Frank noted work is also ongoing for infectious disease programs.
For our Universal flu program P. D. S O to O. Two preclinical work has been progressing steadily and I hope to have a more detailed update on those preclinical studies by the time of our next earnings call.
Four P D S O to O three the planned phase <unk> clinical study cannot be initiated until amitiza provide approval to our partner in Brazil on the core we will be conducting a full program review with final court to determine the appropriate path forward.
I would now like to turn the call over to our Chief Financial Officer, Seth Van Voorhees to review, our second quarter 2021 financials Sam.
Yes.
Thank you Lorne and good morning, everyone.
Let's now turn our discussion to review of our financial results.
For the three and six month periods ending June 30 of 2021.
Loss from operations was approximately $5, one an $8.2 million, respectively versus a loss of approximately $2 nine and $7 million respectively. During the same periods in 2020.
During the second quarter of 2021.
Our operating loss was positively impacted by approximately $4.5 million from the sale of our New Jersey tax benefit pursuant to the New Jersey technology business tax certificate transfer net operating loss program.
Our net loss for the three and six months period, ending June 32020, 'twenty, one excuse me June 30 of 2021.
Was approximately 0.6 and $3.6 million respectively.
Our negative three cents and 16 cents per basic and diluted share.
First is our net loss for the three and six months period, ending June 32020 of approximately $2.9 million and $7 million, respectively, or negative 19 cents and 54 cents per basic and diluted share.
For the three and six month period, ending June 30 of 2021 research and development expenses totally approximately $2.8 million and $4.2 million respectively as.
As compared to 1.4 and $3.4 million, respectively for the same period in 2020.
These results. These results reflect an increase of approximately 1.3 and zero point $8 million, respectively for the three and six months period, ending June 32021 versus the same period in 2024, reflecting higher levels of clinical related activity.
For the three and six months period, ending June 32021 general and administrative expenses were approximately two three and $4.0 million, respectively as compared to approximately 1.5 and $3.6 million respectively for the same periods in 2020.
These results reflect an increase of approximately 0.8 and zero point $4 million, respectively for the three and six months period, ending June 32021 versus the same period in 2020.
Reflecting higher levels of personnel cost.
Looking at cash flow, we started the second quarter of 2021 with approximately $25 million of cash.
We ended the second quarter of 2021 with $75 million.
Reflecting an increase of approximately $50 million.
This increase in cash assets was a consequence of cash added from the sale of the New Jersey Nols in May and the secondary offering completed in June.
Cash used in our operations during the second quarter of 2021.
An important highlight of the second quarter was the capital raised in our secondary offering.
In June we completed a public offering of approximately $6.1 million shares of common stock and raised gross proceeds of approximately $51.7 million before deducting underwriting discounts commissions and other expenses.
And if it's Gerald and company acted as the sole book running manager for this offering.
This oversubscribed offering enabled pdfs biotech to successfully achieved one of its strategic goals to increase its institutional ownership by attracting investments from new and existing institutional investors.
Many of the institutional investors that participated in this offering have strong track records, where their investments with other biotechnology companies.
BD apparel technology intends to use the proceeds from this offering to advanced its ongoing phase two HPV cancer focused pds or 101 clinical programs Advair.
Advance the development of its non HPV cancer focused Pds, a one O two and M. P. B S. O 103 programs based on TARP, and Marc one androgens, respectively, including the initiation of clinical phase one two programs.
And for the continued development of its first meeting technology platform.
The appreciation of our share price since the beginning of this year has coincided with a significant increase in the average daily trading volume of our shares which has increased which has greatly increased liquidity for existing and future investors.
In addition, our recent inclusion in the Russell Microcap Index may build on this momentum to further increase liquidity and to continue to grow shareholder value.
Thank you for your time today and I'd like to now turn the call back to Frank for final remarks.
Thank you Seth and Lauren.
I would also like to thank our extremely vulnerable team members here, our Pds biotech and all of our clinical partners for their continued excellent work.
Without the expertise of our teams and the successful collaborative efforts this quarter's milestones would not have been possible.
The second quarter has been extremely important for PDF biotech.
The previously unseen level of objective responses in advanced refractory cancer reported by the National Cancer Institute.
<unk> hundred one trial provides the first proof of concept data in advanced refractory cancer for our various immune technology platform.
Our capital raise of approximately $52 million further strengthens our balance sheet and provides pds biotech with the funding necessary to aggressively advance our immuno oncology pipeline.
The company is well positioned and we plan to build on the current momentum to move quickly to the next phase of growth by continuing to successfully execute our three ongoing phase III clinical trials for <unk> hundred one.
And to progress Pdfs of one or two and P. D. S. A one a three inch.
Into human testing.
We are also looking forward to continuing to build awareness of Pds biotech within the investment community.
That concludes our preferred remarks.
Operator, please begin our question and answer session.
Thank you at this time, we'll be conducting a question and answer session.
If you would like to ask a question. Please press star one on your telephone keypad.
Confirmation tone will indicate your line is in the question queue.
You May press Star two if you would like to remove your question from the queue.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Our first question today is from Louise Chen of Cantor Fitzgerald. Please proceed with your question.
Hi, congratulations on all the progress in the quarter and thanks for taking my questions. Here. So my first question is why or how does the data that you've seen so far for one O. One give you confidence in a positive outcome for your Keytruda combo trial.
Secondly for P. D. S O. One O three just curious where you think you would fit in the treatment paradigm if approved because some of the indications you're going after after a crowded like non small cell lung cancer and then third question is for P. D. S. O. One O. Two your TARP you stated in your presentation that you were looking.
Or potentially looking at AML. So just curious if he malignancies an area you're interested in pursuing and if so how do you plan to build a franchise around that thank you.
Thanks, a lot for your questions and I'll stop and Loren will probably jump in also as we go ahead. So for the first question regarded the peak the results from the P. D. F. O 101, NCI led trial and how and we believe the results impact the Keytruda trial.
So one key thing to note with the NCI trial is the fact that this was a basket trial and contains a number of different cancers, including head and neck cancer, which is specific to the keytruda trial.
And we saw uniformly and uniform.
You can see across the various types of cancers, including head and neck cancer.
And also very importantly, as Lauren described and the fact that we saw regression only in the HPV 16 positive patient population.
Suggests strongly that P. D. S O. One O. One is specifically activating HPV 16, CDA T cells as it is designed to do.
This is the specific population that we are also looking at with Keytruda. So the Keytruda study specific to HPV 16 positive head and neck cancer.
So there was the results we obtained from the NCI trial are highly encouraging based upon that.
But suppose it or implied activation of the CD eight T cells, which would be critical for the Keytruda trial now we have seen synergy between checkpoint inhibitors and diverse immune technology in preclinical studies. So as you know with the.
The checkpoint inhibitors Keytruda for example has been shown to be quite effective at blocking the tumors defenses and making the cancer of the tumor cells much more visible to the immune system.
And so we see strong synergy with these checkpoint inhibitors, where once those tumors are made more visible to the immune system versus mean by training recruiting and generating a large number of T. Cells. Can then go in and effectively killed <unk> camouflaged with tumor cells right. So that's the synergy that we are expecting.
With the Keytruda trial, and that's what gives us a lot about.
What we believe is highly promising based upon the results that we are seeing currently in the NCI led a trial.
And let me answer the first question.
Yes. Thank you.
Okay, and then I'll go to the top the top study next so with top as we.
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There the.
<unk> is expressed in a 100% of AML approximately 90% of prostate cancers and about 50% of breast cancers. Now. The initial study that has been performed by the NCI that that validated tariff off the target for these for these cancers, what's done in prostate cancer.
And as a risk mitigation strategy. They approach pdfs mistaken is actually just start with prostate cancer.
Right and with AML, we understand that it is heavily expressed in AML, but one of the things we want to do is to take our time and really understand that bladder cancer space before we rush into it.
Forming clinical trials and the blood cancer. So we initially starting with prostate and breast and we will evaluate the AML space more closely before we actually get into any clinical trial for AML specifically.
Okay.
And then with P. D S O one O three the Mach one cancers and so with that currently what we are doing currently is looking at combinations with PD one three at the NCI and these studies are currently being performed at the NCI just like they did with P. D. F O one O one.
And then one based upon that those resolved as Lauren mentioned.
Those results will inform our clinical design and specifically what indications in Macquarie and in what stages of those cancers, we will be addressing but we will take a very close look and also just as we've done with P. S. O. One O. One we do intend to be very strategic in addressing those kinds of looking at the potential.
For whatever combination we'd go into in that specific population of patients that we start to address. These trials then we may actually start without with a basket trial like we did with pdfs owe under one and to really understand exactly how it's impacting patients with the different types of cancers, and then make the final decision as to which ones would be.
Please provide the greatest opportunity for PDF biotech.
Thank you very much.
Yeah.
The next question is from Leland <unk> of Oppenheimer and company. Please proceed with your question.
Great. Thanks, and congratulations on the on the progress question maybe.
Maybe first for Lauren or Frank with respect to the versatile trial I know you reiterated the timelines for the initial data later this year or Q1.
On the 16, if you've got a 26 sites activated though just kind of curious to ask if there's any impact that you're seeing from Covid 19 with respect to getting some of the age where maybe you can say exactly get it over with enrollment in guidance geographic spots and I have a follow up thank you.
Lauren I'll hand that over to you.
Great Yes, thank you Leland.
Well, everyone experienced we did experience initial impacts from the Covid 19 pandemic.
Our experience since we have reactivated the trial as of last fall is that all of our institutions and partners that were working with have already put in place well established mitigation procedures to address Covid 19, and we've been able to progressively bring more and more sites on.
Board.
As the <unk>.
And then it continues to evolve.
Regionally and globally.
There is a potential that.
Sites, maybe impact and again in terms of a constraint on local resources. However, one of the issues that we've heard continuously from all of our science is that because versatile zero zero to target patients with advanced recurrent cancers that have high unmet medical need.
They are among the priority trials that.
Better supported to continue.
Enrolling.
Again, our enrollment has picked up and we do anticipate being able to report by the.
Fourth quarter, some initial data Merck.
<unk> safety are at currently and first quarter of 2022.
Okay. Thank you and then one question kind of a higher higher altitude question.
Can you just study.
The first being platform in the context of different antigens and particularly as you.
You know first the completion of the preclinical work on I know, one or two with TARP in Europe. So obviously looking at one other one I wanted to ask about what Youre seeing in terms of the you know the consistency with.
With respect to the C D. A killer T cell potency and durability that you are getting you know when you apply the knee surgery.
Concept, if there's anything more you can share in terms of the observations you've seen pre clinically.
Okay, So long and I can I can start with that sense.
So I mean, I think that that's an interesting question and one question that we often get is.
What's the impact and when you combine self antigens with with <unk>, especially in some of these other Kansas, where the antigens may may already be present, not due to a foreign agents.
Now. This is this is what we're evaluating with the top with Marc one and we've also done that with TRP too in melanoma.
And in each of these cases, what we have found out is that with versus mean by being able to effectively recruit T cells and prime them to specifically recognize those antigen.
But even though they are the do it yourself antigen. Thank each and every one of these cases, we have seen CDA T cell responses in the preclinical models very similar to what we saw with P. D. S O 101 right.
It is it is highly suggestive.
If we can actually activate the right immunological pathways and effectively presents the antigen into the right processing and presentation pathways that we may be able even with those cells tumor cells antigen based cancers to generate very similar immune responses to what we see with <unk> hundred one.
And actually the study that was done by the National Cancer Institute and led by Dr. Wood looking at path in prostate cancer patients is also very highly suggestive that if properly presented that we should be able to potentially generate similar levels of anti tumor responses.
Even with these other types of antigens.
Appears to be highly dependent on effective recruitment effective presentation and activation of the REIT immunological signaling pathways.
Okay.
Yeah. Thank you for taking the questions.
The next question is from Joe, but goodness of H C. Wainwright. Please proceed with your question.
Hey, everyone. Good morning, Thank you for taking the question.
Wanted to ask a question regarding your farmer core update for the Covid vaccine. Frank I was just curious you know.
From a logistical standpoint in.
In manufacturing the antigen.
Are there any technical issues that pharma core is experiencing any logistical issues or and does this cause any sort of.
Cook missing of contractual obligations.
Well. Good question I think these are some of the key questions that we are seeking to understand with the review that we are currently performing with pharma.
And so hopefully in the next couple.
A couple of weeks, we will have a much better understanding of exactly what's going on and exactly what the next steps could potentially be but these are the key things that we are seeking to much better understand with our.
Ongoing review review of the program currently.
Got it thank you very much.
Youre welcome.
Okay.
The next question is from Robert Leboyer of Noble capital. Please proceed with your question.
Good morning, and thanks for the comprehensive review of all the data could you just give the milestones that are upcoming for the three trials in <unk> hundred one.
Yes, so with <unk>.
Laura why don't you go ahead.
Sure. Good morning, Robert Thanks for the question. So the key milestones for the NCI led Triple combination study, we anticipate accrual to that study is projected to complete during the first quarter of 2022, we also anticipate that more mature data.
Regarding our greater complemented patients won't be available in the first half of 2022.
Regarding the Pds sponsored versatile 002 study looking at <unk> 101 in combination with Keytruda. We project that we will have some preliminary data at the end of the fourth quarter or early Q1 of 2022 that specifically also includes the evaluation.
The initial safety cohort assessing the safety of the combination.
The trial and then for the MD Anderson led trial with P. D. S. L 101 in combination with standard of care chemo radiation therapy, we expect some preliminary data by the first half of 2022.
Alright, great. Thank you very much.
The next question is from Jim Malloy of Alliance Global Partners. Please proceed with your question.
Hey, guys. Thanks for taking my question just had a quick question on the.
The 75 million cash where do you allocate that to your pipeline how do you see the allocation going between the multiple.
Charles you have ongoing.
And can you talk a little bit about you know does the infusion of cash.
Increase spend in any particular direction that perhaps you know before you'd been holding back on and can you tell us about the runway for.
Currently.
Right. So I think I think we should have a lot more information on that shortly so what we are doing currently is as I mentioned, we're looking to get PD, one or two in Oman with Korean into human clinical trials next year. We also have relationships with the National Cancer Institute and one of the other things that we.
Would potentially want to do as we discussed at the R&D day is hopefully to move the triple combination into a pivotal trial sometime late next year right to vote. So evaluating all those options now with the with the.
Moving into a pivotal trial involved discussions with our partners at the NCI and also with <unk> serono and those discussions.
Discussions will be initiated a spam Laura mentioned, we are looking to complete recruitment of that trial.
Potentially early in the first quarter of next year.
And what we want to do is to have enough data and the specific patient population before approaching the FDA to have discussions on what the regulatory pathway could potentially be.
So that is in that that is in the works in terms of what we do there and how we progressed that program. What we have assumed is that we are going to be financially responsible for at least one of the P. D. S. A one or two trials moving forward and what we are currently doing is in the process of designing that trial.
So we will have more information once we understand exactly what that trial design is going to look like and how much that trial is going to cost.
With P. D. S O one O three us both Loren and I mentioned the work that's being done currently of the National Cancer Institute is also going to inform specifically about trial design.
And the agreement we have with under the creator with the NCI is that they they would potentially fund that clinical trial. So as you can see there are a number of moving pieces that are currently in discussion. What we are confident about is the fact that we have the capital necessary to pursue these paths forward, but the deep.
The details will depend on exactly what we're doing with our partners and the specific design of those trials and so we anticipate based upon what.
Our projected forecast that we should potentially have.
Enough time with the capital we've raised to get to some meaningful interim data points for these trials that are currently going to be started before we have to go back to the markets, but we will have a lot more information on that once we have decided and then exactly what the trial design is and how we're moving forward with the with any potential pivotal to.
While coming up.
Yeah.
Great. Thank you and then a quick follow up you'd mentioned I think in the past for the phase three for the Triple combo.
You know signing on a potential marketing partner beyond antenna.
Mystery partner and any comments you can put around how those conversations may be going or any potential partnership conversations maybe go into the interest levels.
Post the ESCO data.
I think as I mentioned, all parties are very interested and based upon the very promising data that was generated.
We think there is a potential.
Powerful, especially with the checkpoint inhibitor refractory patients because that's that's the patient population who have very few very few options for treatment and the results were so encouraging in that population.
However, it's one thing to go to the FDA with extremely good results in 12 patients versus going to the SBA with really good results in 30 patients right. So I think I did.
I think what we all have decided to do is to give it some more time.
Let's wait to the fourth quarter or early first quarter. When we have at least the 30 patients recruited and then based upon what the data looks like then let's come up with the strategy and have initiated discussions with the FDA to determine what the best regulatory path would be and if there is some accelerated pathway we could.
We pursue but we would like to have some data in a few more patients before we initiate those discussions with FDA.
Okay.
Great. Thank you for taking the questions.
No problem.
As a reminder, if you would like to ask a question. Please press star one on your telephone keypad.
There are no additional questions at this time I'd like to turn the call back to Frank <unk> for closing remarks.
Thank you very much.
Yeah.
Thank you very much to all for your continued interest in P. D S biotech.
We believe that 'twenty 'twenty, one will continue.
To be an exciting year for the company.
We have multiple ongoing clinical trials with <unk> hundred one in various advanced HPV associated cancers.
We appreciate your ongoing support in this pursuit.
For more information about the company and our ongoing clinical trials. Please visit our website or Pds biotech dot com.
You very much again.
This concludes today's conference you may disconnect your lines at this time. Thank you for your participation.
Okay.
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