Q1 2020 Earnings Call
And answer session that the question during the session, we'll need to press star one on your telephone we ask that you. Please limit yourself to one question and one follow up question. Please be advised of today's conference is being recorded if you require any further assistance. Please press star zero I would now like to have the conference over to your speaker today, they're karma.
Operator: To ask a question during the session, you will need to press star 1 on your telephone. Please limit yourself to one question and one follow-up question. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero.
Operator: I would now like to hand the conference over to your speaker today, Tara Carmody, Executive Director, Investor Relations and Corporate Communication. Thank you. Please go ahead, ma'am. Good morning.
<unk> Executive director Investor Relations and corporate communications. Thank you. Please go ahead ma'am.
Good morning, welcome to my thought as first quarter 2020 conference call. We issued a press release earlier. This morning, reviewing our first quarter 2020 results in business update which will be covered on this call a replay of today's call.
Operator: Welcome to Mersana's first quarter 2020 conference call. We issued a press release earlier this morning reviewing our first quarter 2020 results and business updates, which will be covered on this call. A replay of today's call will be available on the investors and media section of our website.
The available on the Investor and media section of our website.
Operator: After our prepared remarks, we will open the call for Q and A. Before we begin, I'd like to mention that our call will contain forward-looking statements within the meaning of federal securities laws. These are not statements of historical fact and are based on management's beliefs and assumptions and on the information currently available. They are subject to risk and uncertainties that could cause the actual results and the implementation of the company's plans to vary materially, including the risk that our early encouraging preclinical results for XMT-1536 and XMT-1592 are not necessarily predictive of the results of our ongoing or future discovery programs or clinical studies, that the development and identification of our company's product candidates and new platforms will take longer and or cost more than planned, and that our clinical trials will not be completed on schedule if at all.
After our prepared remarks, we will open the call for Q and <unk>.
Well, we begin I'd like.
Mentioned that are callable contain forward looking statements within the meaning of federal securities laws. He they're not statements of historical facts in are based on managements beliefs and assumptions and on the information currently available.
They are subject to risks and uncertainties that could cause the actual results and the implementation of the company's plans to very material, including the risks that are early encouraging preclinical results for X.M.T. 15, 36, an X.M.T. 15, 92 are not necessarily predictive oh, the results of our ongoing or future discovery programs.
Clinical studies that the development and identification of our company's product candidate and new platforms will take longer and or cost more than plan and that our clinical trials will not be called was completed on schedule if at all.
These risks are discussed in the Companys FCC filings, including without limitation. The Companys annual report on form 10-K filed on February 2020, funny and subsequent filings.
Operator: These risks are discussed in the company's SEC filings, including, without limitation, the company's annual report on Form 10-K, filed on February 28, 2020, and subsequent filings. In addition, while we expect that the COVID-19 pandemic might adversely affect the company's preclinical and clinical development efforts, business operations, and financial results, the extent of the impact on the company's operations and the value of and market for the company's common stock will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantine, physical dis Except as required by law, the company assumes no obligation to update these forward-looking statements publicly, even if new information becomes available in the future. With that, I'll turn the call over to Anna Protopapas, Mersana's President and Chief Executive Officer.
In addition, while we expect that the Colvin 19 pandemic might adversely affect the company's preclinical and clinical development efforts business operations and financial results.
Extent of the impact on the company's operations and the value of and market for the company's common stock will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time.
That's just the ultimate duration of the Pandemics travel restrictions quarantine physical distancing and business closure requirements in the U.S. and in other countries and the effective goodness of actions taken goldberg globally to contain and treat disease.
Except as required by law the company assumes no obligation to update these forward looking statements publicly even if new information becomes available in the future.
With that I'll turn the call over to add a part of topic my thought as president and Chief Executive Officer.
Thank you Sarah.
Anna Protopapas: Thank you, Sarah. Good morning, everyone, and welcome to our financial and corporate update call for the first quarter of 2020. Joining me today with prepared remarks are Dirk Hoepner, our Chief Medical Officer; Tim Loehringer, our Chief Science and Technology Officer; and Brian DeSchuytner, our Senior VP of Finance and Product Strategy. Eva Jack, our Chief Business Officer, and Michael Koffman, our Senior Vice President of Manufacturing, are also available for your questions. Since the beginning of 2020, we've made great strides towards advancing our programs and executing against our key milestones. Although the COVID-19 pandemic has impacted us around the world in unprecedented ways, we quickly changed the way we do our work to ensure the safety of our employees and our patients while continuing to advance our key programs with a focus on delivering on our corporate goals and milestones.
Morning, everyone and welcome to or for young children or adults be cool for the first quarter two pills and twin peaks. Joining me today was prepared for me books are good Cooper, our Chief Medical Officer, Pip lower drew a cheap starting to pick molecule for sure and Brian. The show you see there will be purifying there could put extracting cheap.
You bet, Josh what Chief business Officer, and Michael Kauffman Senior Vice President of Mcgee factory are also available for your questions. Since the beginning of two thirds of the twin peaks, we made great strides towards advancing a programs and executing a good so two milestones.
Well go to coal becoming team put them because in part because the world is unprecedented ways. We quickly adopt it the way we do our work to ensure the seeks to blur employees. They know patrons, while continuing to advance a key programs with a focus on delivering on a corporate goals and milestones.
Anna Protopapas: I will provide a high-level overview of what we have achieved this quarter, and then Dirk, Tim, and Brian will provide more details. Before I begin, today is World Ovarian Cancer Day, and I'd like to take a moment to recognize the women living with ovarian cancer, their families, and the many patient advocacy groups around the world promoting awareness for this devastating disease.
I would like to hide up an overview of what we hope achieved this quarter and the good too, but Brian will provide more details.
Before I begin.
Today is won't do very intensity and I'd like to take a moment to recognize the women living with ovarian cancer deaths families and the baby patient advocacy groups around the world promoting nowhere just for this devastating disease.
Anna Protopapas: and Limited Treatment Options for These Women. Today, we at Mersana reiterate our support and commitment to developing life-changing ADC therapeutics for those affected by ovarian cancer. With that, I would like to turn to the exciting data we recently presented from the Phase I Dose Escalation Study of 1536 in heavily pretreated patients with ovarian cancer and lung adenocarcinoma. These data demonstrate that XMT1536 has a favorable safety and tolerability profile without the severe neutropenia, neuropathy, or ocular toxicity seen with other APCs. We saw confirmed responses in durable, stable disease in heavily pretreated patients who had exhausted all other options and showed an emerging biomarker response relationship.
It remains a significant unmet medical need and limited treatment options for these women.
Today, we were sauna right its weakest supported by developing blogs changing APC to reputed put those affected by ovarian cancer.
With Doug I would like to turn to be excited because we recently presented for the phase one dose escalation study assisting 36 in heavily pretreated patients with ovarian cancer and loved it didn't know carcinoma. These data demonstrate the X P 50 56 has it.
The wearable safety and Tolerability profile without the severe you true P., Neil you won't because he.
CCP see with other bdcs.
We still could form responses in chewable staple Pcs in heavily pretreated patients who have exhausted all out the auctions and show good emerging biomarker. We sports relationship. We also announced that we had reached the maximum tolerated dose of 43 milligrams could be two square and I don't know grid.
Anna Protopapas: We also announced that we had reached the maximum tolerated dose at 43 milligrams per meter squared and are no longer enrolling patients in the dose escalation portion of the study. Second, we remain on track to disclose early data from the ongoing expansion study of XMT 1536 and are very pleased to report that our abstract has been accepted for a poster session at the ASPR 2020 virtual annual meeting to be held between May 29th and May 31st. In advance of the virtual ASCO poster session, we plan to hold a conference call and webcast to discuss this data on May 27th at 8 a.m. Eastern Standard Time. We will be joined on the call by Dr. Debbie Richardson, Associate Professor of Gynecological Oncology at the Stevenson Cancer Center at the University of Oklahoma Health Care Center and the Sarah Cannon Research Institute.
All the patients to the doses can be should push the study.
Second we remain on track to disclose or do you think this will be ongoing expansion study well, except P. 50, 36, and I'm very pleased to support to the abstract has been accepted for poster session at the I've put themselves or the twin people are true I go between to be held between the baked would be dying to.
Thank you first.
So I took the virtual school poster session, we plan to hope to calling for its cold and wet comes to discuss this data or Btwenty seven eight yep Eastern standard time, we will be joining the call like Dr. Debbie Richardson. So she prefers to critical logical colucci at the Stevenson.
She said truancy the Bush supercritical by Health Care Center, and the say, we're kind of research Institute.
Anna Protopapas: As we have indicated in the past, this interim disclosure of the expansion cohorts will be heavily skewed towards ovarian cancer. DERC will provide more details on the scope of our disclosure, but we believe we have accumulated meaningful patient experience to continue to support favorable safety and tolerability, a promising activity profile, and to further establish a biomarker response relation. A third important milestone for us is initiating dosing of patients in the XMT-1592 phase one dose escalation study in the first half of this year. We believe we're on track to achieve this goal, an important first step in better understanding the potential clinical differentiation of XMT-1592. A fourth set of goals is associated with our early stage pipeline. We remain on track to reach our ADC development candidate milestones this year.
As we help indicated that lost this into a disclosure the expansion cohorts will be heavily skewed towards the buried cats.
George will provide more details on the scope of work disclosure, but we believe we help but you really get meaningful patient experience to continue to support favorable safety and Tolerability publishing activity profile into fourth were stuff, we should be more Cooley sports relationship.
A third important milestone for us.
Initiated dosing of patients to be except P. 50, 92 phase one dose escalation study the first half of this year. We believe we're on track to achieve this school and important for stepping back to understanding the potential clinical differentiation, though because it P 59 p. too.
Affords said the goals she said associated with it or do you see each pipeline we remain on track to reach our APC do belbin can be peak milestones. This year. We have initiated argued the it'd be building studies with vseven each for and I would track to disclose big deal discounted deep the second half will do you you know dish.
Anna Protopapas: We have initiated IND-enabling studies with B7H4 and are on track to disclose data on this candidate in the second half of the year. In addition, we're continuing to advance our immunosymptom platform and remain on track to select our first immunosymptom candidate in the second half of the year. Finally, we added $65 million in gross proceeds through our ATM with participation based on interest received from Alvaro Bain Capital, Consonance Capital, and our Chairman Dave Mott. This strengthens our balance sheet and will be used to support our operations as we continue to advance our pipeline of innovative ADC candidates. With that overview, I would like to pass it on to the team who can give you more details on the progress we have made across all aspects of our business. Now, let me turn the call over to Dirk first to discuss 1536.
And we're continuing to advance really viewed it seems that platform and remain on track to see like forced to muted the tragedy in the second topic here.
Finally, we added 65 million to gross proceeds through our ATM participation based on interest received football Borobio capital cost of capital in a chip, but it's more the strengths. It's a balance sheet and will be you used to support operations as we continued to advance.
So pipeline no, but people 80, sicad disease, we dug overview I would like to pass it onto the team who could give you more details on the pool first we have made across all aspects about business, Let me turn call over to Doug first to discuss 50 36.
Thanks Anna.
Dirk: Thanks, Anna, and good morning, everyone. As Anna mentioned, we were very pleased to present positive data from the phase 1 dose escalation study of XMT1536 in heavily pre-treated patients with ovarian cancer and NSCLC adenocarcinoma, two areas of significant unmet medical need. The cutoff date for this evaluation was February 3rd, and it included 59 patients. 37 were ovarian cancer patients, 11 had NSCLC, and the remainder were patients with more rare tumors potentially expressing NAPI-2B. I will now highlight the key findings of the study presented by our Chair of the Safety Review Committee, Dr. Deborah Ritchie. These data show that XMT1536 is well-tolerated without the severe toxicities of other ADC platforms, such as neutropenia, peripheral neuropathy, or ocular toxicity. The most common treatment-related adverse events were grade 1 and 2, nausea, fatigue, headache, and the most frequent grade 3 treatment-related AE was transient ASP elevation.
Good morning, everyone.
As I mentioned, we were very pleased to prevent positive data from phase one dose escalation study actually MTV sifting 36 heavily pretreated patients with ovarian cancer and if you don't see Dino crossing normal.
That's all significant unmet medical need.
The cut off stage well this evaluation was February Threerd and included 59 patients.
37 for ovarian cancer patients 11, head and if you will see and the remainder real patients were more re upped your most potentially expressing not Peter b.
No I like to keep finding off the study presented by our share off the sixth your with your comments he talked about the Bora Richardson.
These data show that ex Infusystem 36 is well tolerated regardless to reports to the team of other agency platform success.
For PGR peripheral neuropathy awful lot toxicities.
Most common treatment related adverse events were grade wanting to know Adriano she had they and the most frequent right threed treatment related eight was trends and I guess she elevation.
Dirk: There were no dose-limiting toxicities observed in the 43 mg per m2 cohort. As a reminder, these were patients with a median of five prior lines of therapy and, in most cases, had run out of other treatment options. Longitudinal studies have shown that as ovarian cancer patients progress, the potential for response decreases rapidly with lines of therapy, and that the expected response rate is close to zero for these patients. However, we saw further confirmed partial responses in ovarian cancer and our first confirmed partial response in an NSCLC adenocarcinoma patient. The fact that we saw confirmed partial responses and durable, stable disease in this patient population is very encouraging and supports further development of XNT1536 in the ongoing dose expansion study, in addition.
There were no dose limiting toxicities observed in the 43 milligrams per script middle cohort.
As a reminder, be for patients with immediate no five quarter lines of therapy and in most cases had ron older other treatment options.
Longer term to know studies have shown that answer regarding cancer patients progress the potential for response decreasing rapidly with lines of therapy and that you expected response rate, it's close to zero for these ovarian cancer patients.
We saw further confirmed partial responses in ovarian cancer.
And offer US confirmed partial response didn't NSCLC ideal CACI normal pace.
Tax every so often from partial responses and durable stable disease in this patient population that's very encouraging.
And supports for about development Opex Infusystem 36 in the ongoing goals expansion studies.
In addition.
The favorable biomarker response trend warm ups or.
Dirk: A favorable biomarker response trend was observed for the subset of evaluable patients treated at 30 mg per square meter and above who had higher NAP2B expression. 5 or 15 or 33% of patients achieved partial response, and 6 out of 15 or 40% of patients achieved stable disease, for a disease control rate of 11 out of 15 or 73 percent. In contrast, there were no responders in the low NAPI-to-VX crossing group.
Well the self said all your valuable patients treated a 30 milligram per square meter and the ball, who had higher lucky to be expression.
Five all 16 or 33 potential patients achieved partial responses and six oral 15, well, 40% off pacing XI stapler diseases.
For the disease control rate, all 11 over 60 or 73%.
In contrast, there were no response in the no nothing to be expressing rule.
Dirk: This is important because it indicates the potential for a patient selection strategy that can identify patients most likely to benefit from XMP 1536. Before I move on to the XMT 1536 dose expansion study, I'd like to remind you that the first two patients in the 52 milligram per square meter dose escalation cohort experienced dose reductions, which allows us now to declare the 43 milligram per square meter dose as the MTD for X The dose escalation portion of the study is now closed for new enrollment. As Anna mentioned, our XMT 1536 Expansion Abstract was accepted by ESSCO and will be presented on a conference call and in a poster session at the ESSCO 2020 virtual meeting being held on May 29th. [inaudible] The data will include safety, tolerability, and efficacy for patients treated with 36 milligrams per square meter.
This is important because it indicates the potential for patient selection strategy, which can identify patients most likely to benefit from excellent T 15 36.
Before I move onto your ex empty trips in 36 Stope extension study I'd like to read mine. That's the first two patients in that 52 milligram per square meter dose escalation poor experience built production, which allows us now to be clear supported three milligram per square meter.
Joe's asked the MTD core X M T 16 36.
The dose escalation portion will start to you know close for new enrollment.
As I mentioned or Exome T 15, 36 expansion that's right.
Accepted by escrow and would be presented on a conference call and in a poster session at the ASCO 20 trend virtual meeting being held May 29.
30 for us.
The data will improve safety tolerability and efficacy for patients treated with 36 milligram per square meter and 43 milligram per square meter as a reminder, your expansion study, which was initiated a 36 milligram per square meter August scruples no.
Dirk: As a reminder, the expansion study, which was initiated at 36 mg per m2 in August 2019, was later amended to enroll patients at 43 mg per m2 and continue to enroll patients at this dose level. With a cutoff date of May 1st, 2020, the presentation will include 20 resistible ovarian cancer patients and four resistible NSCLC patients; biomarker expression data will be available for the majority of evaluable patients. Digital patients are enrolled in the study but have not yet reached the recess evaluation time. Given the limited duration of follow-up today, we do not expect to have mature data on duration of response. We expect to provide more information on durability of response when we report more mature data.
And then what's later amended to enroll patients at 43 milligram per square meter and continue to enroll patients at this dose level.
For the cut off date of May for trend threaten the presentation willing to trend you racist invaluable ovarian cancer patients.
And for resist invaluable NSCLC patients.
Biomarker expression data will be available for the majority off your valuable patients.
There's no patients are enrolled in the study, but have not yet reached the resets evaluation standpoint.
Given the limited duration of follow up today, we do not expect to have short data on duration of response.
We expect to provide more information on durability of response from core more mature data.
Dirk: Remember that the ovarian cancer and lung adenocarcinoma patients being treated in the dose expansion study are still heavily pretreated and platinum resistant, but more homogeneous with one to three prior lines of therapy in ovarian cancer and some patients having four prior lines of therapy regardless of platinum status. In NSTLC adenocarcinoma, patients have failed chemotherapy, PD1, either alone or in combination, and those harboring an on Our goal is to enroll 40 to 45 patients in both ovarian cancer and NSCLC adenocarcinoma corona. As we have said in the past, we believe the expansion cohorts will provide proof of concept for XMT 1536 and will allow us to chart a path to approval, particularly in ovarian cancer where there is precedent for a single-arm registration trial. I will now turn the call over to Tim Loewenger to discuss our research and development work.
Remember that through ovarian cancer and lung adenocarcinoma patients being treated in the dose expansion study, that's still heavily pretreated and platinum resistant, but more homogeneous with 123 prior lines of therapy in ovarian cancer and some patients having four prior lines of therapy, regardless of.
Platinum status.
In NSCLC, our general cost your normal patient care favored chemotherapy PD, one either alone or in combination and those harboring oncogenic driver mutations and targeted therapy.
Our goal is Trimble 40 to 45 patients in both varying cancer and its young customer war.
As we have said in the path. We believe the extension cords would provide proof of concept for ex ante switched in 36 and will allow us to shop the path to approval, particularly early in ovarian cancer, where the is precedent.
For a single arm registration trial.
No true under called over two to lowering her to discuss our research and development work.
Thanks, Derek and good morning, everyone.
Tim Loewenger: Thanks, Dirk, and good morning, everyone. I will start with our first-in-class B7H4 ADC development count. We're excited about the 3DC target and believe it is well suited for the unique characteristics of our DOLA-LOC payload and platform. We have compelling preclinical efficacy and non-human primate tolerability data with both dolaflexin and dolacintin ADCs targeting B7H4. Initiation of IND-enabling studies is ongoing, and we recently initiated cell line development. We remain on track to disclose our development candidate and the supporting data in the second half of this year.
I will start with our first in class B seven age for 80 feet development counted it.
Were excited about the CDC target and believe it is well suited for the characteristics of our dollar law payload and plot core.
We have compelling preclinical efficacy and non human primate tolerability data with both dollar flexing endorsement that 80 feet targeting be fairly limited for.
Negotiation of I'd, enabling studies is ongoing and we recently initiated cell line development.
We remain on track to disclose our development candidate and the supporting data in the second half of this year.
We've also continued to make important progress in our immuno Synthon platform design and the selection of our first thing I can if you see clinical candidates.
Tim Loewenger: We've also continued to make important progress in our immunosymptom platform design and the selection of our first stengagonist ADC clinical candidate. As a reminder, the goal of the immunosymptom platform is to take ADCs beyond the traditional cytotoxic payloads to immunomodulatory payloads, and preclinical studies show that they can be safely and efficiently delivered to the tumor and stimulate an antitumor innate immune response. We have a robust set of efficacy and tolerability preclinical data across multiple targets and remain on track to finalize the immunosymptom platform design and select our first steng agonist ADC development candidate in the second half of 2020. We're excited about the potential of this platform and believe that activating the innate immune system to fight cancer in a targeted manner is a potential game-changer.
As a reminder, the goal of the immune system platform is to take ADCC beyond the traditional fight epoxy payloads, two immunomodulatory payloads and preclinical studies show the potential to be safely and efficiently deliver it to the tumor can stimulate an anti tumor innate immune response.
We have a robust set of efficacy and tolerability preclinical data across multiple targets and remain on track to finalize the immune system platform design and select close first thing agonist 80 feet development candidate in the second House 2020.
Were excited for the potential of this platform and believe that after they be innate immune system to fight cancer in a targeted manner is a potential game changer.
Before I turn the call over to Brian I would like to note that last quarter, we announced that we plan to presented preclinical data on 80 feet created with adults Anthony and immune systems and platforms at the American Association for cancer Research annual meeting.
Tim Loewenger: Before I turn the call over to Brian, I would like to note that last quarter, we announced that we plan to present preclinical data on ADCs created with adult symptom and immunosymptom platforms at the American Association for Cancer Research annual meeting. Since that time, AACR has changed the meeting to a virtual format, and we will now be presenting this data as part of a virtual poster session scheduled for June 22, 2020. These data will include preclinical data from our work on XMT5092, Adolescent ADC-Targeting MAPI 2B, and our novel immunosymptom Sting Agonist ADC platform. The abstracts outlining these data will be made available by AACR on May 15th. We look forward to being able to share this exciting work. And with that, I will turn the call over to Brian DeSchuytner for an overview of our financial results.
Since that time HCR has changed the meeting for virtual format and we will now be presenting this data as part of a virtual poster session scheduled for June 22nd 2020.
These data will include preclinical data from our work on X M. P. 50, 92, adults that 80 feet targeting not b to b.
Our novel immuno Synthon Sting agonist Hdc platform.
Abstract outlining these data will be made available by HCR on may 15th we.
We look forward to being able to shared this exciting work.
With that I will turn the call over to Brian The site work for an overview of our financial results.
Thank you Tim Good morning, everyone and thank you for joining us today today I'll review some of the key financial highlights from our first quarter 2020 results and I'll start with our cash position.
Brian C. DeSchuytner: Thank you, Tim. Good morning, everyone, and thank you for joining us today.
Brian C. DeSchuytner: Today, I'll review some of the key financial highlights from our first quarter 2020 results, and I'll start with our cash... We ended the first quarter of 2020 with approximately $78.4 million in cash, cash equivalents, and marketable securities, compared to approximately $100 million at the end of 2019. Net cash used in operating activities in the first quarter was $21.2 million, compared to $24.7 million in the same period in 2019. Net cash used in operating activities increased by approximately $9 million when compared to the fourth quarter of 2019, mainly due to the timing of compensation payments as well as a reduction in the account's payable balance. As a reminder, in 2018, we set up an at-the-market, or ATM, financing facility in the amount of $75 million.
We ended the first quarter 2020, with approximately $78.4 million and cash cash equivalents and marketable securities compared to approximately $100 million at the end of 2019.
Net cash used in operating activities in the first quarter was $21.2 million compared to $24.7 million in the same period in 2019.
Cash used in operating activities increased by approximately $9 million when compared to the fourth quarter of 2019, mainly due to the timing of compensation payments as well as your production I think accounts payable balance.
As a reminder, in 2018, we set up but at the market for ATM financing facility in the amount of $75 million on April seven we announced that we had raised gross proceeds of approximately $65 million through this facility. We participation based on interest received from of oral capital Advisors Bain capital light.
Brian C. DeSchuytner: On April 7th, we announced that we had raised gross proceeds of approximately $65 million through this facility with participation based on interest received from Avoro Capital Advisors, Bain Capital Life Sciences, Consonance Capital Investors, and David Mott, Mersana's Chairman of the Board. Through this transaction, we sold approximately 8.9 million shares of the company's common stock at a purchase price of $5.59 and approximately 2 million shares at a closing price of $7.74, in each case, the market price at the time of the sale. In addition, we have the option to draw additional funds of up to $15 million through the existing debt financing agreement with Silicon Valley Bank. Today, we are providing updated cash runway guidance following the ATM transaction. We expect that our current cash, cash equivalents, and marketable securities, including the proceeds from the ATM facility, will enable us to fund our operating plan into early 2022.
Sciences continents capital investors and David bought resigned as chairman of the board.
Through this transaction, we sold approximately 8.9 million shares of the company's common stock at a purchase price of $5.59 and approximately 2 million shares at closing price of $7.74 in each case.
Market price at the time of the fail.
In addition, we had the option to drive additional funds of up to $15 million to be existing debt financing agreement with Silicon Valley back.
Today, we're providing updated cash runway guidance following the ATM transaction, we expect that our current cash cash equivalents and marketable securities, including the proceeds from the ATM facility will enable us to fund our operating plan into early Twentytwenty too.
And now some of the key highlights from our first quarter 2020 financial results.
Brian C. DeSchuytner: And now some of the key highlights from our first quarter 2020 financial results. Collaboration revenue in the first quarter of 2020 was immaterial when compared to $41 million for the same period in 2019. This decrease in collaboration revenue was primarily a result of the recognition of $40 million in deferred revenue in the first quarter of 2019 associated with the discontinuation of the partnership with Takeda. Research and development expenses for the first quarter of 2020 were approximately $12.2 million, compared to $15.1 million for the same period in 2019. The variance was primarily due to an upfront payment for the technology license fee in 2019, and the timing of research efforts, the decrease in expenditures in support of partner programs, and a decrease in manufacturing costs for 1536 and 1522, all offset by an increase in S&P 1536 clinical expenses, as well as the advancement of the companion diagnostics development efforts for the NAT2B biobank.
Aberration, rather than in the first quarter 2020 was immaterial when compared to the $41 million for the same period in 2019. This decrease in collaboration revenue was primarily a result at the recognition of $40 million in deferred revenue in the first quarter 2019 associated with the discontinuation of the partnership with Takeda re.
Research and development expenses for the first quarter 2020 were approximately $12.2 million compared to $15.1 billion for the same period in 2019 variance was primarily due to an upfront payment for technology license fee and 29 team and the timing research efforts the decrease in expenditures in support of partner programs and it.
Decrease in manufacturing cost for 15, 36, and 15 22.
All offset by an increase in FMT 15, 36 clinical expenses as well as the advancement of the companion diagnostics development efforts for the enough to be biomarker.
General and administrative expenses for the first quarter of 2020 were approximately $4.9 million compared to $4.4 million in the same period in 2019.
Net loss for the first quarter 2020.
$16.9 million were 35 cents per share compared to a net income of $21.9 million were 72 cents per share from same period. In 2019. The difference was attributable over year over year was attributable to that $40 million in deferred revenue recognized in the first quarter of 2019.
Brian C. DeSchuytner: General and administrative expenses for the first quarter of 2020 were approximately $4.9 million, compared to $4.4 million in the same period in 2019. And a net loss for the first quarter of 2020 was $16.9 million, or $0.35 per share, compared to a net income of $21.9 million, or $0.72 per share, for the same period in 2019. The difference was attributable, year over year, to that $40 million in deferred revenue recognized in the first quarter of 2019. Weighted average common shares outstanding for the quarters ended the 31st of March 2020 and the 31st of March 2019 were approximately $48 million and $30 million, respectively. Common shares outstanding as of May 5th, 2020, were approximately 59 million. This count includes the shares issued in connection with the April ATM transaction, as well as the exercise of approximately 2.6 million pre-funded warrants by BVS, pursuant to the Common Stock Exchange Agreement signed in November 2019. I will now turn the call back to Anna.
Weighted average common shares outstanding for the quarters ended 30.
31st of March 2020.
30, Onest of March 29 team were approximately 48 million in 30 million respectively.
Common shares outstanding as of May 5th 2020 were approximately 59 million.
Discount includes the shares issued in connection to the April ATM transaction as well as the exercise of approximately 2.6 million pre funded warrants by Bbs pursuant to the common stock exchange agreement signed in November 2019.
I will now turn the call back to add.
Thank you Brian.
90, but didnt make has brought challenges for all of US I'm proud of them are standard team's commitment to science patients and the team's ability to continue to execute or don't goals in the mid.
Disruption.
I'd like to tick up over to discuss the impact of the pandemic and mitigation strategies, we have put in place to reduce risk and ensure Christmas contiguity, especially CAD.
First and in line with the guidance from the West Central disease control in prevention and to stick to Massachusetts, We have implemented work from home Bancshares for all North London.
Anna Protopapas: Thank you, Brian. The COVID-19 pandemic has brought challenges for all of us. I'm proud of the Mersana team's commitment to science and patients and the team's ability to continue to execute on our goals in the midst of such a disruption. I'd like to take a moment to discuss the impact of the pandemic and the mitigation strategies we have put in place to reduce risk and ensure business continuity as best we can. First, and in line with the guidance from the U.S. Center of Disease Control and Prevention and the state of Massachusetts, we have implemented work-from-home measures for all non-lab employees and have suspended all business travel. We have also implemented processes to ensure we continue to advance our ADC development candidates while working to ensure the safety of our team. While most of our lab employees also continue to work from home, we have prioritized lab activities and implemented staggered schedules in the interest of safety and efficiency.
And have suspended all business travel.
We have also implemented processes to ensure we continued to advance our APC development can be beach, while working to ensure the seek skills like team well most of our loved employees also continued to work from home, we prioritize lapa cubic piece and have implemented docket schedules in the interest of seat.
The efficiency, we will continue to monitor the situation and continue to follow federal state and local quite lunch and direct thanks.
From a clinical study perspective, the covert 19 put Debbie is a book to all sites in hospitals in the U.S. and other countries, but cancer patients will always meet treatment, we have taken steps with possible for remote monitoring and remote testing consistent with.
If FDA guidance and we've been focused on ensuring the patients were benefiting continue their treatment.
We have over 20 sites up and running with joke graphic diversity across the U.S. These sites no hope experience with Exome T. 15, 36 and are excited about its potential benefit to patients and are continuing to enroll patients at the trial dose screaming of new patients how slow down.
Anna Protopapas: We will continue to monitor the situation and continue to follow federal, state, and local guidelines and directions. From a clinical study perspective, the COVID-19 pandemic is a burden on all sites and hospitals in the U.S. and other countries, but cancer patients will always need. We have taken steps where possible for remote monitoring and remote testing consistent with FDA guidance and remain focused on ensuring the patients we're benefiting can continue their treatment. We have over 20 sites up and running with geographic diversity across the U.S. These sites now have experience with XMT 1536 and are excited about its potential benefit to patients and are continuing to enroll patients in the trial. The screening of new patients has slowed down to some extent.
To some extent.
Additionally, we had plans to bring new sites up and some of those activities are ongoing but certain site.
Initiation of you tried some temporary coat.
Lastly on the but are you factoring front, we have sufficient inventory exome T 15, 36, and excepting 15, 92 to support ongoing and planned clinical studies and sufficient inventory in advance intermediates don't posted the U.S. to support greater than two years with manufacturing.
Drug substance drug product overall, we feel good about where we all of this front.
Finally, before I turn the call open for questions I would like to provide an update on our expected milestones for the rest of the year.
Anna Protopapas: Additionally, we had plans to bring new sites up, and some of those activities are ongoing, but certain sites have put the initiation of new trials on temporary hold. Lastly, on the manufacturing front, we have sufficient inventory of XMT-1536 and XMT-1592 to support ongoing and planned clinical studies and sufficient inventory of advanced intermediates stockpiled in the U.S. to support greater than two years of manufacturing of the drug substance and drug product. Overall, we feel good about where we are on this front. Finally, before I turn the call over to questions, I would like to provide an update on our expected milestones for the rest of the year. I'll start with 1536.
I started with 15 36.
And should we remain on track to provide an interim look at the expansion study data or the conference call live webcast and you know virtual poster session adopted we believe me we had previously guided to being able to provide a more mature look at this data in the second half of the year. Our objective is to continue to execute.
What's the go you the cold.
Disruption impacts of ability to deliver that cold we will provide guidance is appropriate to reiterate non small cell lung cancer. What do you know capacity nobody enrollment continues to lag behind those area. This is likely to continue to be true in the context of the Colby team put Debbie.
Anna Protopapas: As I mentioned, we remain on track to provide an interim look at the expansion study data on a conference call and webcast and in a virtual poster session at ASCO in late May. We had previously guided to being able to provide a more mature look at this data in the second half of the year. Our objective is to continue to execute towards that goal. If the COVID-19 disruption impacts our ability to deliver on that goal, we will provide guidance as appropriate. To reiterate, non-small cell lung cancer, adenocarcinoma enrollment continues to lag behind ovarian cancer, and this is likely to continue to be true in the context of the COVID-19 pandemic. For XMT 1592, we remain on.
EXL T 15, 92, we remain on track and look forward to dosing.
Patients in the second quarter 2012.
As for a pipeline development candidates it as Tim said, we believe we're still on track to disclose a piece of it each for investing in DC development candidates into supporting data the second half of this year.
Overall, we are either good place from a business continue to stand point and I. Thank our employees for this and admired the continued dedication to drive as we all work together to get through these efforts to types.
We remain committed to achieving the milestones we laid out at the beginning of the give and reaching our overarching goal significantly improving outcomes for people living with cats.
Anna Protopapas: Thank you very much. As for our pipeline development candidates, and as Tim said, we believe we're still on track to disclose our B7H4 and Sting ADC development candidates and the supporting data in the second half of this year. Overall, we are in a good place from a business continuity standpoint, and I thank our employees for this and admire their continued dedication and drive as we all work together to get through these uncertain times. We remain committed to achieving the milestones we laid out at the beginning of the year and reaching our overarching goal of significantly improving outcomes for people living with cancer. With that, I will turn the call over to the operator for Q&A.
With that I will turn the called over to the operator for acuity.
As a reminder to ask a question you will need to press star one on your telephone to withdraw your question press the pound King we ask that you. Please limit yourself to one question on one follow up question. Please stand by what we compile the kunaev roster.
Our first question comes on the line of Jonathan Chang from SVB Leerink. Your line is now open.
Good morning, and congrats on the progress and thanks for taking the questions. My first question.
Based on other data that we've seen in the platinum resistant ovarian cancer space when could make the argument that an earlier like patient population activity should accrue would it be fair trap that expectation other dose expansion dataset concentric dose escalation datasets.
Operator: As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. We ask that you please limit yourself to one question and one follow-up question. Please stand by while we compile the Q&A roster. Our first question comes from the line of Jonathan Chang from SVB Larynx. Your line is now open.
Why or why not.
So thank you for the question John This is.
As we've said before the patients were treated in the expansion cohorts are still heavily pretreated patients platinum resistant patients with three potentially four nights of therapy and its you know the standard of care. There is single agent chemotherapy Pegylated books.
Anna Protopapas: Good morning and congratulations on the progress and thanks for taking the question. First question, based on other data we've seen in the platinum-resistant ovarian cancer space, one could make the argument that an earlier line patient population activity should improve. Would it be fair to have that expectation of your dose expansion data set compared to your dose escalation data set? Why or why not?
Uhhuh piece on top of Teekay and the response rate there is pretty well.
Stoppage the response shrieks similarly to chemotherapy, so really no but to the 12% response, we did the media, though PFS.
Anna Protopapas: So, thank you for the question, Jonathan. As we've said before, the patients we're treating in the expansion cohort are still heavily pre-treated patients, platinum-resistant patients, with three, potentially four nights of therapy. And as you know, the standard of care there is single-agent chemotherapy, peculated doxorubicin, and topotecan, and the response rate there is pretty well established. However, the response rate for single-agent chemotherapy is really no better than a 12% response rate in a median of PFS. As you recall from our dose escalation data, we've seen confirmed responses and prolonged stable disease in these very heavily pretreated patients, significantly later stage patients than what the expansion cohort population represents. So we've already achieved a significantly superior response rate in later stage patients. And I think that establishes a level of activity that supports moving forward into a registration, a faster market registration path. So, could it get better with the earlier? Of course, it could. But I don't necessarily think it has to, to have a meaningful drug that can really benefit patients and to have a path forward, a faster market registration strategy.
As you recall.
Sunday should be done we've seen couldn't sort of responses and prolong Steve it's very heavily pretreated patients significantly later stage patients.
The expansion cool population.
Sets so we've already.
She was significantly superior response rate later stage patients and.
He said the stuff wishes and level of activity.
That supports moving forward to a registration list as cost about kicked registrations Oh Paul.
So.
We didn't get said to with the idea of course, it could but I do think it has to have a meaningful drugs.
That's a business patients into how the possible.
Cost more chiquita station strategy.
Got it. Thank you and just second question you indicate that the majority of the valuable patients from the expansion will have biomarker data I'm curious has your thinking around the craft one of the nappy to be expression and potential addressable population changed.
With your experience in both the dose escalation and expansion.
I'm sorry.
Jonathan can you repeat the question.
Anna Protopapas: Thank you. And just a second question, you indicate that the majority of the valuable patients from the expansion will have biomarker data. I'm curious, has your thinking around the prevalence of NACP2B expression and potential addressable population changed with your experience in both the dose escalation and expansion?
Sure you indicated that the majority of these valuable patients from the expansion will have biomarker data I'm I'm curious, if you're thinking ground prevalence I'm happy to be expression and the potential addressable population has changed but they experience you guys have.
Had any dose escalation and expansion questions yes.
Anna Protopapas: I'm sorry, Brian, Jonathan, can you repeat the question?
So as we've said we do not we topic, we're going to stop topped off also we are encouraged with the biomark to response.
Anna Protopapas: Sure, you indicated that the majority of the valuable patients from the expansion will have biomarker data. I'm curious if your thinking around the prevalence of NAPI2B expression and the potential addressable population has changed with the experience you guys have had in the dose escalation and expansion portions.
I don't see I would like to do you get the totality of the date of school all the patients the expansion cohort. It really you stuck with stuff published the Cardona.
Anna Protopapas: So, as we've said, we do not, we haven't really established a cutoff, although we're encouraged by the biomarker response data we are seeing. What we'd like to do is get the totality of the data from all the patients in the expansion cohort and really use that to establish the cutoff. That being said, we continue to be encouraged that we are seeing a good correlation, and we continue to be encouraged that our understanding of the range of expression of ANABI-2B in ovarian cancer patients remains consistent from the clinical experiences we did in all the work leading up to entering the clinic, all the work we did with tissue samples, and we feel we understand the broad expression.
That being said we continued to be encouraged that we are seeing.
Good co relation to you to be in college that our understanding Oh.
Page over expression, the or not be to be.
Cancer patients remains consistent from the clinical experience as we did it also work leading up to entry into the clinic all the work we did winds tissue samples.
We feel we understand the growth expression.
Got it thank you.
Thank you. Our next question comes from a line of Doug.
Anna Protopapas: Got it. Thank you.
Shut the body from H.C. Wainwright. Your line is now open.
Operator: Thank you. Our next question comes from the line of Devjit Chattopadhyay from HC Wainwright. Your line is now open.
Hi, Good morning, everybody happy Friday, Congrats on all the progress.
Anna Protopapas: Hi, good morning everybody. Happy Friday. Congratulations on all the progress. This is O.
Okay.
Just a few questions from us so.
Of the majority of the 20 patients.
Anna Protopapas: B. Sousa, InfraDebJet. Just a few questions from us. Of the majority of the 20 patients that you will be presenting, would those be from the 36th MIG cohort? And I know you talked about it earlier during your... remarks, but what is the length of follow-up for these patients? And a follow-up question would be... I guess my second question would be, what kind of durability of disease control would convince you to head towards a single-arm registration path? Thank you.
If you will be presenting would that be from the 36 make cohort and I know you talked about it earlier doing euro.
Remarks, what did.
Let me follow these patients and.
A follow up question would be.
I guess my second question would be what kind of durability of disease control.
Since you had towards a symbol AHP registration path. Thank you.
So take two quick questions the Jeep secure bill.
Anna Protopapas: So, thank you for the question, Devjit. The durability really is, it really will depend on, as you can appreciate, we have patients that have been on study for just a few weeks, and we have patients that have been on study for six months or more. So, as we have said in the past, The data, the mature data, will be disclosed in the second half of the year. It's a little premature to really determine the duration of treatment, given that we have such a variation in the time of patients being on the trial. As for your question about the mixture of 36 and 43, I'd like to defer to my colleagues. Maybe Dirk has that answer.
It really will depend on it you can appreciate we talked patrons of her feed on study quick just a few weeks and when a patient study for six months or more so.
The Pos.
He said the mature data.
Well no second half of the yes, it's a little premature.
For me.
Two rate should.
And Mike.
Good.
How much variation time, all Oh peaches.
Well I know.
As for your question about.
Make sure.
Well, we like to defer to my colleagues, maybe door counts, but Uh huh.
Yeah. This is Dirk I welcome that question.
Anna Protopapas: ..
Dirk: Yeah, this is Dirk. I welcome that question. As you, as we said on the call, the 36 milligrams per square meter dose cohort was started in August last year. And from that perspective, we certainly have patients in that cohort. We moved, or started moving over to the 43 milligram in December. So we have patients in both the 36 and the 43 that are available for assessment at presentation. It's split somewhat in half, if you like, but of course, because the 36 milligram patients are on study longer, we're gonna have a little bit more duration on those patients compared to the 43.
As you.
As we said on the call. The 36 milligram per square meter dose cohort will started in August last year.
And from that perspective, we you have certainly patients and that cohort. We moved started moving over to 43 milligram in December.
So we have patience in both the 36 and reported three.
That I available for assessments at the presentation.
Splits.
Somewhat in half if you like.
It's a of course, because the 36 milligram patients on study lumber you're going to have lived with more.
A duration on those patients compared to before the three.
Thank you.
Dirk: Thank you.
Thank you. Our next question comes from the line of Boris Peaker from Cowen. Your line is now open.
Operator: Thank you. Our next question comes from the line of Boris Peaker from Cowen. Your line is now open.
Anna Protopapas: Good morning, and I'd like to add my congratulations on the progress. My first question is, I'm just curious, as you enroll more patients, and, obviously, in this dose expansion arm, at which point do you anticipate being in a position with adequate data in hand to discuss the regulatory path forward for ovarian cancer with the FDA?
Good morning, and I'd like to add my congratulations on to the progress.
First question is is just curious as you enroll more patience and obviously in a dose expansion arm, which point do you anticipate to be in a position with the kind of adequate Dan data in hand to discuss the regulatory path forward in ovarian cancer with the FDA.
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Anna Protopapas: A great question, Boris, and one we are discussing internally. We had originally said and planned that we would recruit 40 to 45 patients. We thought that was a reasonable patient experience to make well-informed decisions and have a really meaningful discussion with the FDA. Obviously, as the data evolves, we're continuing to look at that, but that was the plan, and we remain on that.
Oh, Great question before he said one we are discussing in towards the we had originally said and plans that we would recruit 40 to 45 patients we thought that was a reasonable.
Patient experience to bake well informed decisions and have the really meaningful discussion with the FDA, obviously as the de Novos, we're continuing to look at that.
But.
We remain on Oh, that's not at this point.
Anna Protopapas: Great. And just my follow-up question, just logistically, on the 1536 study, I'm curious, are these patients, or the majority of these patients, being treated in the hospital or in the outpatient setting? And how frequently do they need to show up at the facility, and how long do they stay for every treatment?
Great and just my follow up question just logistically on the 15 36 study.
At every treatment.
Dirk: Dirk, I think you might be able to give a better answer to that question.
Oh sure I think you might be able to bed to give it to that question.
Sure Yeah, no. It's an open outpatient setting so patients come in pool.
Dirk: Sure.
Dirk: Yeah, no, it's an outpatient setting. So patients come in for dose administration, and then what usually happens thereafter is some collection of blood samples for different things, for lab values, pharmacokinetic collection, et cetera. So that happens on the first day, they come back on the second and third day, but they don't stay in the hospital, and then we follow up on a weekly schedule with those patients.
For dose administration, and then what's usually happens thereafter, some collection off blood samples for different things.
Well, let values pharmacokinetic girls collection et cetera, so that happens on the first day they come back on the second and third but they don't stay in the hospital and then follow up on the on the on a weekly schedule those patients.
And just how long do they typically stay for each visit like with the infusion and all the assessment I'm just curious.
Dirk: And just how long do they typically stay for each visit, like with the infusion and all the assessments? I'm just curious.
Yeah. The first day, it's a little longer but could be up to eight hours.
Dirk: Yeah, the first day is a little longer. It could be up to eight hours. The follow-up days would be shorter.
Oh the follow up.
Dirk: Great, thank you for taking my question.
Dates are working or would be shorter.
Great. Thanks for taking my question.
You're welcome thanks.
Operator: You're welcome. Thanks.
Thank you. Our next question comes on line of Tom Shrader from BTI. James Your line is now open.
Operator: Thank you. Our next question comes from the line of Tom Schrader from BTIG. Your line is now open.
Good morning, congratulations thanks for taking the coal I apologize. If this is obvious to everyone else, but may twentyth is that 20 or those all new patients.
Operator: Good morning, congratulations. Thanks for taking the call.
Anna Protopapas: I apologize if this is obvious to everyone else, but May 20th, is that 20? Are those all new patients? I remember there had been some doses, or some of the doses, or some of the doses had been expanded the last time we saw data. So is this all new patients?
Remember there had been some doses or some of the doses at some of the doses had been expanded the last time, we saw a data. So is this all new patients.
Anna Protopapas: The 20 patients that we are evaluating in the study, the 20 ovarian patients are part of the expansion cohort, and they're all different patients than the ones we disclosed in the dose escalation.
On the 20 patients that are a valuable and studies it could feel very and patients apart.
Oh, the expansion cohort and they're all patients of the ones, we disclosed in the dose escalation.
Great. Thank you Linda if I could have good nerdy question for Tim.
Anna Protopapas: Great, thank you.
Tim Loewenger: And then, if I can,
Tim Loewenger: for Tim. On the immunosymptom program, so much of the sting work has been dictated by direct tumor injection. Do you expect to go after the same tumors that have been done before? Are there hints in the literature where sting might be exciting but you couldn't get to with non-systemic routes? Just your thoughts on whether you think there's low-hanging fruit in terms of tumor type for that kind of approach.
You know Synthon program. So much of this thing work has been dictated by direct tumor injection.
Do you expect to go after the same tumors would have been done before their hinson the literature worse things like the exciting, but you couldn't get too with non systemic roots. Just just your thoughts on whether you think there's low hanging fruit in terms of tumor type for that for that kind of approach.
Tim Loewenger: Sure, Tom, I love the nerdy questions. I think we're very pleased with the progress we're seeing in our immunosymptom sting agonist ADC platform, and we look forward to disclosing the first candidate in the second half of this year. I think what I can say is that we have data now across multiple targets, so it's not just a single target, and we think we have a very good understanding of what targets are appropriate and also which ones may not be. And so I think that's all I can really say today, but stay tuned for the second half. We'll disclose the data if that's helpful. Thank you.
Sure Tom I Love the nerdy questions [laughter] I think I think with for very pleased with the progress we're seeing in our immuno Synthon Sting agonist PDC platform.
We look forward can disclosing the first candidate in the second half of this year I think what I can say is that we have.
Data now across multiple targets.
So it's not just with single target and we think we have a very good understanding of what targets are appropriate and also which ones may not be and so.
I think that's all I can really say today, but stay tuned in the second half, we'll we'll disclose the data.
Oh, that's that's helpful. Thank you.
Operator: Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key.
Thank you as a reminder to ask a question you wanted to press star one on your telephone to withdraw your question pressed the banking we ask that you. Please limit yourself to one question and one follow up question.
Operator: We ask that you please limit yourself to one question and one follow-up question. Our next question comes from the line of Jessica Tsai from J.P. Morgan. Your line is now open. Hey guys, good morning. Thanks so much for taking my questions. Can you please set the stage for the ASCO Abstract and help us think about the difference in the amount of...
Our next question comes from a line of just like aside from JP Morgan. Your line is now open.
Hey, guys. Good morning, Thanks, so much for taking my question.
Can you. Please that the feature the ASCO abstract and help us think about the different the amount of information, we'll get an abstract relative to the full presentation. How many evaluable patients will be in the abstract and when we got safety there. Thank you.
Anna Protopapas: Great question, Jess. Thanks for asking it. As you can appreciate, the abstract was submitted in late January or early February, so I would guide you to look at it more as a placeholder rather than anything else. The data really to look at is our disclosure on May 27th, where we'll have the chance to really walk everyone through the full data set.
Oh, Great question, just thanks for asking it's if you can appreciate.
The.
Abstract submitted in late January early February So I would guide you to look at it more is a place holder rather than anything else.
The data really to look at these dollars disclosure on may 27th what will help the trends to really walk everyone through.
Anna Protopapas: Okay, great.
Through the fall.
Dataset.
Okay great.
Anna Protopapas: And maybe...
And maybe second question is you're building on an earlier one in the press release, you talk about the ASCO Dieter reporting on the relationship between response and biomarker expression. So when investors look at the response rate for the 20 ovarian patients and ASCO should we look at or are across the overall group or should we.
Anna Protopapas: My second question, sort of building on an earlier one, in the press release you talk about the ASCO data reporting on the relationship between response and biomarker expression. So when investors look at the response rate for the 20 ovarian patients at ASCO, should we look at ORR across the overall group, or should we be oriented to a subset of higher expressors?
The oriented to a subset of higher expressers.
We will twisted Bose.
Anna Protopapas: We will present both. And as we've said, we haven't yet definitively defined the cutoff, but we are, as we get more data, looking at that relationship. And as we did in the dose escalation, we'll be able to share both the total population, overall response rate, as well as the response rate relationship, the response biomarker relationship.
Good.
As we've said we are.
Good.
Good news living to find the cut off but we are as we get more data looking at that relationship and as we did in the dose escalation, we'll be able to share. Both the total population overall response rate as well as the response rate relationship to the response biomarker relationship.
Great. Thank you.
Anna Protopapas: Great, thank you.
Operator: Thank you. Our next question comes from the line of Mike Olds from Baird. Your line is now open.
Thank you. Our next question comes on the line of Mike Old from Baird. Your line is now open.
Hi, guys and thanks for taking the questions congratulations on all the progress as well.
Anna Protopapas: Hi guys, and thanks for taking the questions. Congratulations on all the progress as well. I just had a question about XMT-1536.
Just had a question on X M. T 15, 36, and you mentioned enrollment in non small cell lung is sort of lagging behind ovarian.
Anna Protopapas: You mentioned enrollment in non-small cell lung cancer is sort of lagging behind ovarian cancer. Can you just remind us, is that due to timing of enrollment, or there are other factors that might be driving that?
Can you just remind us that due to the timing of enrollment.
Were there other factors that might be driving that.
Look I think we've always said that enrollment in lung cancer was don't moving as fast as you know bamiyan.
Anna Protopapas: Look, I think we've always said that enrollment in lung cancer was not moving as fast as in ovarian cancer. We started off with a lot more ovarian cancer patients in the dose escalation phase, primarily because we focused on sites that were primarily ovarian cancer recruiting sites. Even with success, we get more success; as we saw more responses in ovary, it accelerated recruitment in ovary. We have been increasing our experience with lung cancer, but it's lagging behind. Other factors beyond just the relative body of data we have between ovarian and lung are that we are lung is more advanced, there are more competitive trials in lung, and we have a number of new sites that were planned to be up and running that were focused on lung today but have been partially delayed. We are still working towards bringing that recruitment up and believe we're on track to recruit the 40 patients we want in the expansion cohort this year, but we're continuing to monitor the situation, and if that changes, we will let you know.
We started off with a lot more ovarian cancer patients in the dose escalation, primarily because we focus on site that had a that would probably by really ovarian cancer recruiting site.
Also with success you get more successes so more responses in ovarian to accelerate that we could you know there yet we have seen increasing our experience with long.
Like we called.
Other slacked goes beyond just the board.
Looking forward looking so we talked between ovarian and lung.
That.
No we are logged into more there are more.
Have you did call I also long and we talk a good number sorry.
We're climb up the broadening.
Personal among today [laughter], partially delayed we're still working towards bringing that.
But often we're on track to recruit booked 40 patients. We won the expansion cohorts you, but we're continuing to mortgage was the situation.
And if that changes we will make no.
Anna Protopapas: Got it. That's helpful. And then maybe just another question on XMT-1592. You're still on track to start your Phase 1 study this quarter, so maybe if you could just talk about the study design there and maybe your dosing strategy as well. Thanks.
Got it that's helpful. And then maybe just another question on X M. T 15 to 92, so you're still on track to study the phase one study this quarter to maybe you could just talk about the study design, there and maybe your dosing strategy as well thanks.
Anna Protopapas: Yeah. We will be recruiting. Our objective in the dose escalation phase is to move through dose escalation as quickly as possible. We will be recruiting both lung and ovarian cancer patients because that's the way we can move through dose escalation as quickly as possible, and the first few doses are single patient dose cohorts. And as we initiate the trial and start dosing patients, we'll be able to share more information with you about that trial.
We will be recruiting Oh objective in the dose escalation is gold.
Dose escalation as quickly as possible, we will be recruiting both lung and ovarian cancer patients because that's the way we could move through dose escalation as quickly as possible.
The first you go schools are single patient dose cohorts and as we initiate the call. It starts dosing patients will be able to share more information with you about that trial.
Anna Protopapas: Got it. Thank you.
Got it thank you.
Thank you Sir our next question comes from the line of David Nierengarten from Wedbush Securities. Your line is now open.
Operator: Thank you. Our next question comes from the line of David Nierengarten from Wedbush Securities. Your line is now open.
Hi, I just have a quick question well will there be and understand it's difficult very any opportunity just see longitudinal biomarker data overtime in Austria, archival samples and comparing them to a fresh samples for hearing cancer before any potential.
David Matthew Nierengarten: I just have a quick question. Will there be, and I understand it's difficult, any opportunity to see longitudinal biomarker data over time, you know, if you have archival samples and, you know, comparing them to fresh samples for ovarian cancer or any of the patients?
Just a question on that so presentation. Thanks.
Anna Protopapas: More questions on that will be raised at the ASCO presentation.
Anna Protopapas: Any questions on that at the ASCO presentation? Thanks. Yeah.
Yeah.
It would not be part of the ASCO presentation.
Anna Protopapas: It will not be part of the ASCO presentation, and at this point, it's not part of the protocol to get paired biopsies from patients we're treating. That's something we might embark on in the future, but it's not part of the current protocols.
At this point, it's not part of the product called to get a paired biopsies from patients were treated that's something we might a block toward the future, but it's not part of the current project calls.
Anna Protopapas: Okay, I understand. Thank you.
Understood. Thank you.
Anna Protopapas: Thank you. At this time, I am showing no further questions. I would like to turn the call back over to Anna Protopapas, President and CEO, for closing remarks.
Thank you at this time I'm showing no further questions I would like to turn the call back over the Anna Proto Papa President and CEO for closing remarks.
I want to thank everyone for participating on the call. We're very excited to have the opportunity to share with you. The expansion cohort data you have a few weeks and look forward to talking to you are good at that time.
Anna Protopapas: I want to thank everyone for participating in the call. We're very excited to have the opportunity to share with you the expansion cohort data in a few weeks and look forward to talking to you again at that time.
Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
Ladies and gentlemen, this concludes today's conference call. Thanks for participating you may now disconnect.
Operator: BF-WATCH TV 2021
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