Bio-Path Holdings, Inc. (NASDAQ: BPTH) This fall 2021 earnings name dated Mar. 11, 2022
Company Members:
Will O’Connor — Investor Relations
Peter Nielsen — President, Chief Govt Officer and Chief Monetary Officer
Anthony Worth — Senior Vice President of Finance, Accounting and Administration
Analysts:
Yi Chen — H.C. Wainwright — Analyst
Presentation:
Operator
Good morning, women and gents. Welcome to the Bio-Path Holdings Full-Yr 2021 Earnings Convention Name. [Operator Instructions] Following the formal remarks, we are going to open the decision up in your questions.
I might now like to show the decision over to Will O’Connor of Stern Investor Relations. Please proceed.
Will O’Connor — Investor Relations
Thanks, operator. Welcome to the Bio-Path Holdings convention name and webcast to evaluation the Firm’s full-year 2021 monetary outcomes and to offer an replace on current pipeline and company developments. Earlier, we issued a press launch, which outlines the matters that we plan to debate on at present’s name. The discharge is on the market at biopathholdings.com.
With me at present from Bio-Path are President and CEO, Peter Nielsen; and Senior Vice President of Finance, Accounting and Administration, Anthony Worth. Earlier than we start the decision, I’d wish to remind you that at present’s dialogue will include forward-looking statements that contain dangers and uncertainties. These dangers and uncertainties are outlined in at present’s press launch and within the Firm’s current filings with the Securities and Trade Fee, which we urge you to learn. Our precise outcomes could differ materially from what’s mentioned on at present’s name.
With that, I’ll now flip the decision over to Bio-Path’s CEO, Peter Nielsen.
Peter Nielsen — President, Chief Govt Officer and Chief Monetary Officer
Thanks, Will. Good morning, everybody, and thanks for becoming a member of us. 2021 was an essential 12 months for Bio-Path. And we’re nicely positioned as we enter 2022 to advance our mission of creating significant Medicare — medicines to help within the struggle towards most cancers. Earlier than we dive into our applications intimately, I’d like to spotlight the progress we’ve made shoring up our provide chain. We made appreciable developments all through 2021, bettering our medical scale manufacturing course of. Our provide chain capability has been doubled, offering a major improve in drug candidate manufacturing capability. As well as, now we have elevated scheduling flexibility for ordering new batches of drug product for our medical trials.
Let me flip now to a extra detailed description of those medical applications and the progress we’re making advancing them by the medical and regulatory pathway. I’ll start with our lead product candidate, prexigebersen, the place we proceed to make strong progress. We proceed to make important progress advancing Stage 2 of our Part 2 medical trial of prexigebersen for the remedy of acute myeloid leukemia or AML together with frontline remedy, decitabine and venetoclax.
As now we have beforehand reported, Part 2 medical growth of prexigebersen AML commenced with Stage 1 of the Part 2 medical trial, which was open label and handled de novo AML sufferers with a mix of prexigebersen and Low Dose Cytarabine or LDAC. The mixture of prexigebersen and LDAC was proven to be protected and extra efficacious to deal with this class of sufferers than with LDAC alone. As now we have highlighted earlier than, there was an evolving panorama for normal of care in AML. Regardless of these new therapies, there are nonetheless sufferers who’re refractory or resistant. And people are the sufferers we purpose to assist. As customary of care developed, we tailored our trial design to mirror these adjustments.
The amended Stage 2 of this Part 2 trial in AML is an open label Part 2 two-stage multicenter examine of prexigebersen together with decitabine and venetoclax in two cohorts of sufferers with beforehand untreated AML and relapsed/resistant AML. A 3rd cohort consists of treating relapsed/resistant AML sufferers who’re venetoclax-resistant or illiberal with the two-drug mixture of prexigebersen and decitabine. The complete trial design plans have roughly 54 evaluable sufferers for the cohort treating relapsed/refractory AML sufferers with the triple mixture remedy of prexigebersen, decitabine and venetoclax, and the cohort treating AML sufferers who’re venetoclax-resistant and illiberal with the two-drug mixture prexigebersen and decitabine with a evaluation of each cohorts carried out after 19 evaluable sufferers.
The complete trial design plans have roughly 98 evaluable sufferers for the cohort treating untreated AML sufferers with the triple mixture remedy of prexigebersen, decitabine and venetoclax with a preliminary evaluation for the cohort carried out after 19 evaluable sufferers and a proper interim evaluation after 38 evaluable sufferers. The upper variety of sufferers within the full trial design for the untreated AML affected person cohort is because of the larger baseline response of the frontline remedy with beforehand untreated AML sufferers. The first endpoint for this examine would be the variety of sufferers who obtain full remission, which incorporates full remission with incomplete hematologic restoration and full remission with partial hematology restoration. An interim evaluation shall be carried out on every cohort to evaluate the security and efficacy of the remedy.
In December, Dr. Maro Ohanian, Affiliate Professor of the Division of Leukemia on the College of Texas MD Anderson Most cancers Heart introduced security and preliminary efficacy information from the continuing Part 2 trial of prexigebersen earlier than an viewers of world-leading oncologists on the 63rd Annual American Society of Hematology or ASH Annual Assembly. The info introduced included six sufferers, 4 sufferers or 67% with de novo AML and two secondary AML sufferers or 33%, that had been handled with at the very least one cycle of prexigebersen plus decitabine mixture remedy.
All sufferers on this cohort with a medium age of 72 years outdated had been thought of high-risk as a consequence of having both hostile threat standing by European Leukemia Internet or ELN or handled secondary AML. Knowledge confirmed that hostile occasions or AEs had been usually in keeping with dose anticipated with decitabine and/or AML. Three of the six sufferers or 50% had a response, together with two de novo sufferers or 33%, who achieved a whole remission with incomplete blood rely restoration or CRi, and one secondary AML affected person or 17%, who achieved a partial remission. Sufferers with these circumstances usually have lower than a 20% CR/CRi response charge. Six sufferers had been handled with at the very least one cycle of prexigebersen plus decitabine plus venetoclax mixture remedy.
Of the six sufferers, two or 33% had de novo AML and 4 or 67% had been relapsed/refractory. All sufferers on this cohort had been hostile threat by ELN or relapsed/refractory. AEs had been usually in keeping with decitabine and venetoclax remedy and/or for AML. 4 sufferers or 67% achieved a CR/CRi or morphological leukemia free state and one affected person, 17% achieved a partial response. Of those 5 sufferers, three had been relapsed/refractory and two had been de novo. That is significant as CR charges for mixture remedy with decitabine and venetoclax for relapsed/refractory AML sufferers are 42% to 52% or 0% to 39% for relapsed/refractory secondary AML sufferers. These preliminary information are compelling and present that prexigebersen-based mixture remedy was not solely safely administered to high-risk and relapsed/refractory AML sufferers thought of unsuitable for normal chemotherapy, but in addition demonstrated encouraging efficacy indicators. That is significantly encouraging as relapsed/refractory sufferers are a difficult inhabitants through which present remedy every choices are suboptimal.
Subsequent, I’d like to show to our deliberate Part 1 medical trial of prexigebersen-A in sufferers with superior strong tumors, together with ovarian, uterine, pancreatic and hormone refractory breast most cancers. Prexigebersen-A, a fourth Bio-Path drug candidate is a modified product from prexigebersen sharing the identical drug substance with enhanced nanoparticle properties. Final 12 months, we had been delighted to announce that the FDA had reviewed and cleared our Investigational New Drug or IND software to provoke a Part 1-Part 1b medical trial of prexigebersen-A in sufferers with strong tumors, together with ovarian, endometrial, pancreatic and triple-negative breast most cancers. This trial shall be carried out at a number of main most cancers facilities and is deliberate initially to guage the security of prexigebersen in strong tumor sufferers. Sufferers recognized with recurrent ovarian or endometrial most cancers usually have poor outcomes, and it’s our hope that prexigebersen could present medical advantages for such sufferers. We stay up for bringing this thrilling program into the clinic within the second quarter of this 12 months.
Turning now to BP1002, our second therapeutic candidate, which targets Bcl-2. As you already know, Bcl-2 is liable for driving cell survival in as much as 60% of all cancers. Excessive expression of Bcl-2 has been correlated with poor prognosis for sufferers recognized with AML. Venetoclax has additionally proven exercise towards the anti-apoptotic protein, Bcl-2 and works by neutralizing the protein’s BH3 area. It’s an authorized remedy for continual lymphocytic leukemia or CLL sufferers and untreated AML sufferers. Nonetheless, except some sufferers handled with allogeneic hematopoietic cell transplantation, illness relapse invariably happens oftentimes as a consequence of BH3 area mutation over time.
BP1002 additionally targets the Bcl-2 protein. Nonetheless, BP1002 exercise relies on blocking the Bcl-2 messenger RNA and never the BH3 area. In consequence, we imagine that BP1002 may present an alternate for venetoclax sufferers who’ve relapsed, together with AML sufferers who beforehand obtained venetoclax therapies. We count on to provoke this medical trial within the second quarter at a number of main most cancers facilities in the USA, together with the Weill Medical School at Cornell College, the College of Texas MD Anderson Most cancers Heart and the Georgia Most cancers Heart.
A complete of six evaluable sufferers shall be handled with BP1002 monotherapy in a normal 3+3 design, with a beginning dose of 20 milligrams per sq. meter. The authorized remedy cycle is 2 doses per week over 4 weeks, leading to eight doses administered over 28 days. The Part 1b portion of the examine will start after completion of BP1002 monotherapy cohorts and can assess the security and efficacy of BP1002 together with decitabine in refractory/relapsed AML sufferers.
Lastly, let’s evaluation the progress we’ve made with our third drug candidate, BP1003, which targets the STAT3 protein. This program has proven promising preclinical information, and we’re very excited for the way forward for this program. We’re finding out BP1003 for the remedy of pancreatic most cancers in a patient-derived tumor mannequin. Earlier fashions have proven the drug to efficiently penetrate pancreatic tumors and improve the efficacy of normal frontline remedy. We stay up for presenting supportive preclinical information from this program on the 2022 American Affiliation for Most cancers Analysis Annual Assembly going down in New Orleans, Louisiana subsequent month.
Dr. Maria Gagliardi, a Analysis Scientist on our group will focus on preclinical research of BP1003 together with paclitaxel and fluorouracil as a possible remedy towards breast and ovarian most cancers. We’re significantly excited to launch our first in-human validation of this cutting-edge remedy in an particularly difficult most cancers indication that has restricted remedy choices. We’re aiming to file an IND software for this very promising product candidate later this 12 months.
With that, I’ll now flip this system over to Anthony Worth for a short evaluation of our full-year 2021 financials, together with steadiness sheet highlights. Anthony?
Anthony Worth — Senior Vice President of Finance, Accounting and Administration
Thanks, Peter. The Firm reported a internet lack of $10.4 million or $1.55 per share for the 12 months ended December 31, 2021 in comparison with a internet lack of $10.9 million or $2.83 per share for the 12 months ended December 31, 2020. Analysis and growth expense for the 12 months ended December 31, 2021, decreased to $5.9 million in comparison with $6.6 million for the 12 months ended December 31, 2020, primarily as a consequence of timing of actions associated to our medical trial for prexigebersen in AML, partially offset by a rise in manufacturing bills associated to drug product batch releases within the fourth quarter of 2021.
Normal and administrative expense for the 12 months ended December 31, 2021 elevated to $4.5 million in comparison with $4.3 million for the 12 months ended December 31, 2020, primarily as a consequence of elevated stock-based compensation expense. As of December 31, 2021, the Firm had money of $23.8 million in comparison with $13.8 million at December 31, 2020. Internet money utilized in working actions for the 12 months ended December 31, 2021 was $9.9 million in comparison with $11.0 million for the comparable interval in 2020. Internet money offered by financing actions for the 12 months ended December 31, 2021, was $20.0 million.
With that, I’ll now flip the decision again over to Peter.
Peter Nielsen — President, Chief Govt Officer and Chief Monetary Officer
Thanks, Anthony. At Bio-Path, we purpose to be revolutionary and environment friendly with sufferers on the forefront of every little thing we do. Our sturdy and rising pipeline continues to advance. And I’m happy with the bolus of medical information that we’ve generated in help of our DNAbilize platform. As we glance to the steadiness of the 12 months, we count on to construct on this with a variety of value-creating milestones, and I stay up for preserving you apprised of our progress.
With that, operator, we’re able to open the decision for questions.
Questions and Solutions:
Operator
Thanks. [Operator Instructions] We’ve got a query from Yi Chen with H.C. Wainwright. Your line is open.
Yi Chen — H.C. Wainwright — Analyst
Thanks for taking my questions. Might you replace us on the present enrollment standing for every of the three arms of the Part 2 trial of prexigebersen in AML?
Peter Nielsen — President, Chief Govt Officer and Chief Monetary Officer
Effectively, enrollment is over 30 [Phonetic] and — for the three mixed. And that was slowed considerably, I feel, as I’ve talked about earlier than, by limitations in drug provide. It’s one of many causes we labored on doubling our provide chain. We had some COVID plant incidents and whatnot. For this 12 months, we predict we’ll add one other 30 [Phonetic], plus 30 [Phonetic] to that. And I feel that we will begin hitting a few of these interim factors in direction of the tip of the fourth quarter — first quarter subsequent 12 months. So we’ll be capable of get some fairly important readouts. So the opposite ones are simply actually beginning up. The lymphoma one has been sluggish, however I feel now we have finished some issues to — recruited some extra assist sources to seek out some sufferers for us. There’s loads of — loads of trials happening in that space proper now. And as we’ve talked about earlier than, getting these first sufferers to get previous 20 milligrams per sq. meter is the milestone. So we proceed to work on that.
Yi Chen — H.C. Wainwright — Analyst
Received it. And which arm do you assume is prone to attain 19 evaluable sufferers first? Is it the third arm, which is the relapsed/refractory AML sufferers who’re venetoclax-resistant or illiberal?
Peter Nielsen — President, Chief Govt Officer and Chief Monetary Officer
It might be the 2 — it might be the 2, the prexigebersen, decitabine cohort. Second behind that might be the second cohort, which is treating refractory-resistant AML sufferers with the triple mixture. However they’re all selecting up now that as I deliver extra drug again up, we’re experiencing it [Phonetic] in all of them, however that might be my evaluation.
Yi Chen — H.C. Wainwright — Analyst
Okay. And the Part 1 trial of BP1002 in lymphoma and CLL, is it nonetheless on monitor to report information within the first half of this 12 months?
Peter Nielsen — President, Chief Govt Officer and Chief Monetary Officer
We’ll should see how these new sources. What we’d report on could be this 20 milligram per sq. meter. We have already got a affected person. We’re beginning to see — we had a few extra sufferers, one ended up not making it by screening. We’ve got one other one which we predict has made it by. So we’ll see if these extra affected person recruiting applications will help us. Once more, now we have to seek out sort of the specialised affected person scenario to drag them in at this stage.
Yi Chen — H.C. Wainwright — Analyst
And for BP1003, when do you count on to file an IND for medical research?
Peter Nielsen — President, Chief Govt Officer and Chief Monetary Officer
Effectively, we’ve simply reviewed that once more yesterday, and the aim is by the tip of the 12 months. The difficulty has been developed, the PK examine, I feel I’ve talked about that earlier than. We’ve got that now being examined and we should always have read-out on that. As soon as now we have that, then we’ll do our closing animal tox examine, which received’t take that lengthy, and we will get that information and be able to compile the IND within the third quarter. In order that’s the sport plan. And I feel now we have the fitting drug, manufactured drug, as a result of we engineer these items with our DNAbilize method. And you need to get the solubility and hydrophobicity appropriate on it, the balancing act, and get that finished. In order that’s the sport plan. We expect we will.
Yi Chen — H.C. Wainwright — Analyst
Okay.
Peter Nielsen — President, Chief Govt Officer and Chief Monetary Officer
We’re actually excited concerning the progress. Okay.
Yi Chen — H.C. Wainwright — Analyst
And lastly, the working bills of the fourth [Phonetic] quarter final 12 months, is an effective place to begin to undertaking numbers for this 12 months as you put together to start out two extra medical trials within the second quarter this 12 months?
Peter Nielsen — President, Chief Govt Officer and Chief Monetary Officer
Okay. You’re speaking about updating your fashions and projecting?
Yi Chen — H.C. Wainwright — Analyst
Yeah, working bills, quarterly working bills?
Peter Nielsen — President, Chief Govt Officer and Chief Monetary Officer
Yeah. I feel we’re going to function at the next stage. I feel 12 months from March by Feb ’23, we’re $14 million in money, okay. And that’s most likely a very good measure for you.
Yi Chen — H.C. Wainwright — Analyst
Okay. Thanks.
Peter Nielsen — President, Chief Govt Officer and Chief Monetary Officer
Sure, certain.
Operator
Thanks. And there aren’t any additional questions within the queue. I’d like to show the decision again to Peter Nielsen for closing remarks.
Peter Nielsen — President, Chief Govt Officer and Chief Monetary Officer
Thanks once more, everybody, for becoming a member of us and in your continued help of Bio-Path. Have an amazing day.
Operator
[Operator Closing Remarks]
