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Bio Path Holdings Inc (NASDAQ: BPTH) This autumn 2022 earnings name dated Mar. 31, 2023
Company Individuals:
Will O’Connor — Investor Relations
Peter Nielsen — Chief Government Officer and Chief Monetary Officer
Anthony Value — Senior Vice President of Finance, Accounting and Administration
Analysts:
Laura Engel — Stonegate — Analyst
Jonathan Aschoff — Roth Capital Companions — Analyst
Presentation:
Operator
Good morning, women and gents. Welcome to the Bio-Path Holdings Full-Yr 2022 Earnings Convention Name. [Operator Instructions] Following the formal remarks, we are going to open the decision in your questions.
At the moment, I’d like to show the ground over to Will O’Connor of Stern Investor Relations. Sir, please proceed.
Will O’Connor — Investor Relations
Thanks, operator. Welcome to the Bio-Path Holdings convention name and webcast to evaluate the corporate’s full 12 months 2022 monetary outcomes and to supply an replace on current pipeline and company developments. Earlier, we issued a press launch which outlines the matters that we plan to debate on right now’s name. The discharge is out there at biopathholdings.com. With me right now from Bio-Path are President and CEO, Peter Nielsen; and Senior Vice President of Finance, Accounting, and Administration, Anthony Value.
Earlier than we start, I’d prefer to remind you that right now’s dialogue will comprise forward-looking statements that contain dangers and uncertainties. These dangers and uncertainties are outlined in right now’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 might differ materially from what’s mentioned on right now’s name.
With that, I’ll now flip the decision over to Bio-Path’s CEO, Peter Nielsen.
Peter Nielsen — Chief Government Officer and Chief Monetary Officer
Thanks, Will. Good morning, everybody, and thanks for becoming a member of us. 2022 was a 12 months wherein we made nice progress executing on our mission to bringing new medicines to the battle in opposition to most cancers. For the illness as evasive and proof against therapies as most cancers, we have to carry daring new approaches to struggle this lethal illness. At Bio-Path, we’re bringing true innovation to the struggle in opposition to most cancers with our DNAbilize platform throughout quite a few hard-to-treat cancers. We’re pleased with the progress we’ve made and impressed by the hope we are able to carry to sufferers with restricted or no therapy choices. In December, we had been delighted to report the initiation of an necessary Part 1b medical trial in BP1001-A in sufferers with strong tumors, together with ovarian, endometrial, pancreatic, and triple adverse breast most cancers, a few of the most difficult cancers to deal with with right now’s therapeutic toolkit.
BP1001-A is a modified product from prexigebersen sharing the identical drug substance with enhanced nanoparticle properties. This trial is being performed at a number of main most cancers facilities, and can initially consider the security of strong tumor sufferers. Sufferers identified with recurrent ovarian and endometrial most cancers typically have poor outcomes and it’s our hope that we might present medical advantages for such sufferers. We look ahead to cohort completion and knowledge readout from this research round midyear.
Subsequent, let’s flip to the progress we’ve made with our lead product candidate, prexigebersen. We proceed to make important progress advancing Stage 2 of our Part 2 medical trials of prexigebersen for the therapy of acute myeloid leukemia or AML together with frontline remedy decitabine and venetoclax. The amended Stage 2 of this Part 2 trial in AML is an open label two-stage multicenter research 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 relapse resistant AML sufferers who’re venetoclax-resistant or illiberal with the two-drug mixtures of prexigebersen and decitabine. The first endpoint for this research 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 therapy. Within the coming weeks, we are going to assess the preliminary security and efficacy of this mixture remedy with the potential to qualify for expanded program standing.
Turning now to our BP1002 program, which targets Bcl-2. If you understand, 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 identified with AML. Venetoclax has proven exercise in opposition to anti-apoptotic protein Bcl-2 and works by neutralizing the proteins’ BH3 domains. It’s an permitted therapy for persistent lymphocytic leukemia or CLL sufferers and untreated AML sufferers. Nonetheless, aside from some sufferers handled with allogenetic hematopoietic cell transplantation illness relapse invariably happens, oftentimes as a result of BH3 area mutation over time.
BP1002 additionally targets the Bcl-2 protein. Nonetheless, BP1002 exercise is predicated on blocking the Bcl-2 messenger RNA and never the BH3 area. Because of this, we consider that BP1002 might present an alternate for venetoclax sufferers who’ve relapsed, together with AML sufferers who beforehand acquired venetoclax therapies. 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 permitted therapy cycle is 2 doses per week over 4 weeks, leading to eight doses administered over 28 days. The Part 1b portion of the research will start after completion of BP1002 monotherapy cohorts and can assess the security and efficacy of BP1002 together with decitabine in refractory relapse AML sufferers. We count on cohort completion and preliminary knowledge readout from this research round midyear.
Lastly, let’s evaluate the progress we’ve made with BP1003, which targets the STAT3 protein. STAT3 is a transcription issue that regulates numerous tumorigenic processes, akin to tumor proliferation, metastasis, and drug resistance. Its overexpression and aberrant activation characterize mini-cancers, together with breast, lung, ovarian, liver, and colon most cancers. Activation of the STAT3 pathway in breast and ovarian most cancers cells promotes tumor initiation, migration, and Taxol resistance. STAT3 additionally promotes 5-FU resistance in colorectal most cancers cells. Its function in quite a few malignancies made STAT3 a possible most cancers therapeutic agent.
BP1003 is a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide that effectively reduces STAT3 expression and enhances the sensitivity of breast and ovarian most cancers cells to Taxol and 5-FU. These outcomes are in step with earlier work wherein BP1003 plus gemcitabine displayed enhanced antitumor exercise in pancreatic, ductal adenocarcinoma. Collectively, these outcomes strongly recommend that BP1003 mixture remedy is a novel technique for sufferers with superior strong tumors. We’re notably excited to launch our first-in-human validation of this innovative remedy in an particularly difficult most cancers indication that has restricted therapy choices. We look ahead to submitting an IND utility for this very promising product candidate later this 12 months.
With that, I’ll now flip this system over to Anthony Value for a quick evaluate of our financials together with steadiness sheet highlights. Anthony?
Anthony Value — Senior Vice President of Finance, Accounting and Administration
Thanks, Peter.
The Firm reported a web lack of $13.9 million or $1.91 per share for the 12 months ended December thirty first, 2022 in comparison with a web lack of $10.4 million or $1.55 per share for the 12 months ended December thirty first, 2021.
Analysis and growth expense for the 12 months ended December thirty first, 2022 elevated to $9.2 million in comparison with $5.9 million for the 12 months ended December thirty first, 2021, primarily as a result of manufacturing bills associated to drug product releases in 2022, elevated enrollment in our Part 2 medical trial for prexigebersen and AML and start-up prices associated to our Part 1 medical trial for BP1002 in refractory relapsed AML sufferers. Common and administrative expense for the 12 months ended December thirty first, 2022 elevated to $4.7 million in comparison with $4.5 million for the 12 months ended December thirty first, 2021, primarily as a result of elevated authorized charges.
As of December thirty first, 2022, the Firm had money of $10.4 million in comparison with $23.8 million at December thirty first, 2021. Internet money utilized in working actions for the 12 months ended December thirty first, 2022 was $15.1 million in comparison with $9.9 million for the comparable interval in 2021. Internet money offered by financing actions for the 12 months ended December thirty first, 2022 was $1.7 million.
With that, I’ll now flip the decision again over to Peter.
Peter Nielsen — Chief Government Officer and Chief Monetary Officer
Thanks Anthony. As I hope we’ve conveyed, we’ve an thrilling 12 months forward with a number of probably worth creating medical milestones throughout our portfolio, together with cohort completion of information readout from our Part 1/1b medical trial of BP1001-A in strong tumors round midyear; cohort completion and knowledge readout from our Part 1/1b medical trial of BP1002 in relapsed/refractory AML round midyear; an preliminary interim security and efficacy evaluation from our Part 2 medical trial of prexigebersen AML starting within the coming quarter.
At Bio-Path, we by no means lose sight of our purpose to carry new medicines to the struggle in opposition to most cancers. It’s a singular mission that drives us to push the boundaries in our work on daily basis with ardour and goal.
With that, operator, we’re able to open the decision for questions.
Questions and Solutions:
Operator
Girls and gents, presently, we’ll start the question-and-answer session. [Operator Instructions]
Our first query right now comes from Laura Engel from Stonegate. Please go forward along with your query.
Laura Engel — Stonegate — Analyst
Good morning, Peter. How are you?
Peter Nielsen — Chief Government Officer and Chief Monetary Officer
I’m doing properly, Laura. Thanks.
Laura Engel — Stonegate — Analyst
Good, good. Effectively, a lot of excellent news, busy, busy as all the time. Combating the great struggle. I really like that the way you completed your feedback. However might you simply remark given not too long ago reported year-end money balances, clearly, the reason for the change within the R&D year-over-year, which you’ve talked about the manufacturing type of particulars how that works a bit of bit otherwise, however simply type of what you see excessive stage, in fact, for the upcoming 12 months comparatively talking as we type of mannequin with every little thing, with all of the completely different packages occurring and attempt to type of get some perception on that?
Peter Nielsen — Chief Government Officer and Chief Monetary Officer
Yeah. Just a little background shade. Recall within the earlier two years with COVID, the manufacturing setting was powerful for us and doubtless for everyone. And each our vegetation had COVID shutdowns and it was tough for them to reestablish manufacturing. And we labored with them. And one of many key issues we did was, we concluded that we would have liked to exit and double our provide chain in each the oligo producer and the drug product producer. The restrictions on drug provide over these two years actually slowed and restricted our enrollment as a result of clearly we’re not taking individuals in if we’ve a threat of chopping them off.
So, we had been very profitable in doubling our provide chain and so we’ve spent a whole lot of final 12 months, type of, in fact, this 12 months within the first quarter wrapping issues up, however final 12 months, constructing our provide of medicine. Recall that our drug product, keep in mind, it’s not permitted. So, subsequently, the ultimate drug product doesn’t have an financial worth and it has to have be expensed as — and we do that when we launch the product. We had an amazing — we had a fourfold enhance in our provide of drug vials, which is necessary as a result of that’s what’s allowed us to type of launch the gates and get the enrollment going. However in fact, the opposite aspect of that coin is that that tremendously will increase your R&D expense as a result of that’s the place it goes.
So, a part of that that you simply see on a year-over-year within the R&D expense is a fourfold enhance within the drug provides and that was a number of million {dollars} of that enhance. I believe that we’d count on the — I don’t have a particular forecast, however I do know that the overall growth expense needs to be in in all probability about possibly the $4 million vary going ahead, however that’s not a studied quantity. I’ve ready a money price range, but it surely goes out and lapse over into the primary quarter of 2024. However it shouldn’t be that as excessive because it was just because we received’t have that arduous push on constructing drug stock.
Laura Engel — Stonegate — Analyst
Nice. Effectively, that was my guess, however I wished to simply go over that with you. And I recognize you giving us the perception. Completely satisfied Friday, and I’ll get again within the queue.
Peter Nielsen — Chief Government Officer and Chief Monetary Officer
Okay. Thanks. Have a terrific one.
Laura Engel — Stonegate — Analyst
You too.
Operator
[Operator Instructions] Our subsequent query comes from Jonathan Aschoff from ROTH MKM. Please go forward along with your query.
Jonathan Aschoff — Roth Capital Companions — Analyst
Thanks. Good morning Peter. I used to be questioning, did you simply say that your R&D will solely be $1 million 1 / 4? Was that $4 million for the 12 months?
Peter Nielsen — Chief Government Officer and Chief Monetary Officer
I believe that as an alternative of $9 million, I might count on it to in all probability be within the $5 million or $6 million vary, however I don’t have a studied quantity. What I believe I attempted to say was it could be down a few million from what we noticed within the final 12 months. So, as a result of I received’t have that enormous stock build-up.
Jonathan Aschoff — Roth Capital Companions — Analyst
Okay. All proper. That undoubtedly makes much more sense. I used to be questioning the venetoclax resistant or illiberal arm for 1001, when may we see knowledge there in addition to 102 in CLL?
Peter Nielsen — Chief Government Officer and Chief Monetary Officer
Okay. The third cohort of the Part 2 trial, is that what you’re asking for?
Jonathan Aschoff — Roth Capital Companions — Analyst
Yeah.
Peter Nielsen — Chief Government Officer and Chief Monetary Officer
Yeah. That one — that one’s, we’ve had lots enrolled, however these are very tough sufferers. That may not be center 12 months, that might be displaying up in all probability within the third or fourth sufferers — quarter. We’ve had fairly a number of come by way of, however these are fairly tough sufferers and it’s tougher to search out them, fairly frankly. However we’ve had lots are available in. So, I believe you’re wanting within the second half of the 12 months for that one. That’s the furthest or the slowest of the three cohorts.
Jonathan Aschoff — Roth Capital Companions — Analyst
Okay. How concerning the CLL trial with 1002?
Peter Nielsen — Chief Government Officer and Chief Monetary Officer
The CLL trial we’ve — we solely want yet one more affected person. We’ve got that affected person to finish out that rollout for that first cohort. And we’ve added two extra, together with [Technical Issues], fairly good establishment, which I perceive they’ve regarded on the protocol and assume that they’ll do some good with it. So, I believe that one — once more, I believe we’ve received to go a number of extra months on that as a result of these institutes received’t be ultimate step and run until June. So, ideally within the third quarter, we’ll have that third stage after which can report out on that first cohort.
Once more, the tough half was — with that trial was there’s an actual — it’s a low dose beginning. It’s a monotherapy, so we don’t have a chemo element to it. And there’s a CAR-T trial occurring that’s enticing to individuals who wish to strive.
Jonathan Aschoff — Roth Capital Companions — Analyst
Okay. And lastly, you mentioned you’d file that IND for 1003 this 12 months, proper?
Peter Nielsen — Chief Government Officer and Chief Monetary Officer
That’s our purpose. We lastly — let me simply once more give the background shade on that. What has slowed us down? We’ve performed every little thing for that. We simply have that ultimate second species tox research to do. And to do this, we’ve to have our PK research accessible. Once more particular for that, with the ability to show that in reality you’ve got drug substance within the animal. We’ve got a profitable PK research that has — technique, I’m sorry, that has labored in our different two medication, has not labored on this third drug and we’ve gone by way of some evaluation.
The molecule has a considerably decrease melting level than the opposite two and we expect that it might not be sturdy sufficient for the chemical additions and steps that go to whenever you get a plasma from an animal that may’t stand up to it. And so it interrupts the binding, which provides off the sign that detects it. So, we’ve needed to give you one other approach for the detection, and we’ve one now. And in reality, this previous two weeks, we’ve been interviewing some giant CROs which have an appropriate technique they usually don’t have a lot of a backlog, which is nice on their mass spec aspect of the enterprise that you must use with this system. And so we expect we are able to get that spherical up and occurring with the precise animal research, solely take two months to check and report. So, we expect we are able to make that IND by the top of the 12 months. However that’s been the difficulty. We’ve been all set. It’s simply we’ve needed to give you a unique know-how to have the ability to detect the presence of the substance within the blood serum.
Jonathan Aschoff — Roth Capital Companions — Analyst
Thanks very a lot, Peter.
Peter Nielsen — Chief Government Officer and Chief Monetary Officer
You’re welcome.
Operator
And women and gents, with that, we’ve reached the top of right now’s question-and-answer session. I’d like to show the ground again over to Peter for any closing remarks.
Peter Nielsen — Chief Government Officer and Chief Monetary Officer
Thanks once more everybody for becoming a member of us and in your continued help of Bio-Path. Have a terrific day. Thanks.
Operator
[Operator Closing Remarks]
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