Bio Path Holdings Inc (NASDAQ: BPTH) This fall 2022 earnings name dated Mar. 31, 2023
Company Individuals:
Will O’Connor — Investor Relations
Peter Nielsen — Chief Govt Officer and Chief Monetary Officer
Anthony Worth — 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-12 months 2022 Earnings Convention Name. [Operator Instructions] Following the formal remarks, we’ll open the decision in your questions.
Right now, 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 offer an replace on latest 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 on the market 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 Worth.
Earlier than we start, I’d wish 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 latest filings with the Securities and Change Fee, which we urge you to learn. Our precise outcomes could 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 Govt Officer and Chief Monetary Officer
Thanks, Will. Good morning, everybody, and thanks for becoming a member of us. 2022 was a 12 months during which 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 deliver daring new approaches to battle this lethal illness. At Bio-Path, we’re bringing true innovation to the battle in opposition to most cancers with our DNAbilize platform throughout a variety of hard-to-treat cancers. We’re happy with the progress we’ve made and impressed by the hope we are able to deliver to sufferers with restricted or no therapy choices. In December, we had been delighted to report the initiation of an necessary Section 1b scientific trial in BP1001-A in sufferers with strong tumors, together with ovarian, endometrial, pancreatic, and triple adverse breast most cancers, among 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 protection of strong tumor sufferers. Sufferers identified with recurrent ovarian and endometrial most cancers typically have poor outcomes and it’s our hope that we could present scientific advantages for such sufferers. We sit up for cohort completion and knowledge readout from this research round midyear.
Subsequent, let’s flip to the progress we have now made with our lead product candidate, prexigebersen. We proceed to make vital progress advancing Stage 2 of our Section 2 scientific 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 Section 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 can be carried out on every cohort to evaluate the protection and efficacy of the therapy. Within the coming weeks, we’ll assess the preliminary security and efficacy of this mix remedy with the potential to qualify for expanded program standing.
Turning now to our BP1002 program, which targets Bcl-2. If you recognize, Bcl-2 is answerable 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 authorised therapy for continual 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 on account 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. Consequently, we imagine that BP1002 may present another for venetoclax sufferers who’ve relapsed, together with AML sufferers who beforehand obtained venetoclax therapies. A complete of six evaluable sufferers can be handled with BP1002 monotherapy in an ordinary 3+3 design with a beginning dose of 20 milligrams per sq. meter. The authorised therapy cycle is 2 doses per week over 4 weeks, leading to eight doses administered over 28 days. The Section 1b portion of the research will start after completion of BP1002 monotherapy cohorts and can assess the protection and efficacy of BP1002 together with decitabine in refractory relapse AML sufferers. We anticipate 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 varied tumorigenic processes, corresponding 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 according to earlier work during which 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 leading edge remedy in an particularly difficult most cancers indication that has restricted therapy choices. We sit up for 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 Worth for a quick evaluate of our financials together with stability sheet highlights. Anthony?
Anthony Worth — Senior Vice President of Finance, Accounting and Administration
Thanks, Peter.
The Firm reported a internet lack of $13.9 million or $1.91 per share for the 12 months ended December thirty first, 2022 in comparison with a internet 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 on account of manufacturing bills associated to drug product releases in 2022, elevated enrollment in our Section 2 scientific trial for prexigebersen and AML and start-up prices associated to our Section 1 scientific trial for BP1002 in refractory relapsed AML sufferers. Normal 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 on account 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. Web 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. Web money supplied 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 Govt Officer and Chief Monetary Officer
Thanks Anthony. As I hope we have now conveyed, we have now an thrilling 12 months forward with a number of doubtlessly worth creating scientific milestones throughout our portfolio, together with cohort completion of information readout from our Section 1/1b scientific trial of BP1001-A in strong tumors round midyear; cohort completion and knowledge readout from our Section 1/1b scientific trial of BP1002 in relapsed/refractory AML round midyear; an preliminary interim security and efficacy evaluation from our Section 2 scientific trial of prexigebersen AML starting within the coming quarter.
At Bio-Path, we by no means lose sight of our purpose to deliver new medicines to the battle in opposition to most cancers. It’s a singular mission that drives us to push the boundaries in our work day by day with ardour and function.
With that, operator, we’re able to open the decision for questions.
Questions and Solutions:
Operator
Women and gents, at the moment, 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 Govt Officer and Chief Monetary Officer
I’m doing properly, Laura. Thanks.
Laura Engel — Stonegate — Analyst
Good, good. Effectively, a number of excellent news, busy, busy as at all times. Combating the great battle. I really like that the way you completed your feedback. However may you simply remark given just lately 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 sort of particulars how that works a bit of bit in another way, however simply sort of what you see excessive stage, in fact, for the upcoming 12 months comparatively talking as we sort of mannequin with every thing, with all of the totally different packages occurring and attempt to sort of get some perception on that?
Peter Nielsen — Chief Govt Officer and Chief Monetary Officer
Yeah. A bit of background colour. Recall within the earlier two years with COVID, the manufacturing surroundings was robust for us and possibly for everyone. And each our vegetation had COVID shutdowns and it was troublesome 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 constraints on drug provide over these two years actually slowed and restricted our enrollment as a result of clearly we’re not taking folks in if we have now a threat of slicing them off.
So, we had been very profitable in doubling our provide chain and so we’ve spent numerous final 12 months, sort 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 authorised. So, subsequently, the ultimate drug product doesn’t have an financial worth and it has to have be expensed as — and we do that after we launch the product. We had an amazing — we had a fourfold improve in our provide of drug vials, which is necessary as a result of that’s what’s allowed us to sort of launch the gates and get the enrollment going. However in fact, the opposite facet 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 improve within the drug provides and that was a number of million {dollars} of that improve. I feel that we might anticipate the — I don’t have a selected forecast, however I do know that the full growth expense needs to be in most likely about possibly the $4 million vary going ahead, however that’s not a studied quantity. I’ve ready a money price range, nevertheless it 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 onerous push on constructing drug stock.
Laura Engel — Stonegate — Analyst
Nice. Effectively, that was my guess, however I needed to only go over that with you. And I recognize you giving us the perception. Completely happy Friday, and I’ll get again within the queue.
Peter Nielsen — Chief Govt Officer and Chief Monetary Officer
Okay. Thanks. Have an incredible 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 Govt Officer and Chief Monetary Officer
I feel that as an alternative of $9 million, I’d anticipate it to most likely be within the $5 million or $6 million vary, however I don’t have a studied quantity. What I feel I attempted to say was it might be down a few million from what we noticed within the final 12 months. So, as a result of I received’t have that giant stock build-up.
Jonathan Aschoff — Roth Capital Companions — Analyst
Okay. All proper. That positively makes much more sense. I used to be questioning the venetoclax resistant or illiberal arm for 1001, when would possibly we see knowledge there in addition to 102 in CLL?
Peter Nielsen — Chief Govt Officer and Chief Monetary Officer
Okay. The third cohort of the Section 2 trial, is that what you’re asking for?
Jonathan Aschoff — Roth Capital Companions — Analyst
Yeah.
Peter Nielsen — Chief Govt Officer and Chief Monetary Officer
Yeah. That one — that one’s, we’ve had rather a lot enrolled, however these are very troublesome sufferers. That will not be center 12 months, that might be displaying up most likely within the third or fourth sufferers — quarter. We’ve had fairly a couple of come by, however these are fairly tough sufferers and it’s tougher to search out them, fairly frankly. However we’ve had rather a lot are available in. So, I feel you’re trying 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 Govt Officer and Chief Monetary Officer
The CLL trial we have now — we solely want yet another affected person. We have now 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 seemed on the protocol and suppose that they will do some good with it. So, I feel that one — once more, I feel we’ve obtained to go a number of extra months on that as a result of these institutes received’t be closing 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 troublesome 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 part to it. And there’s a CAR-T trial occurring that’s enticing to individuals who wish to attempt.
Jonathan Aschoff — Roth Capital Companions — Analyst
Okay. And lastly, you mentioned you’ll file that IND for 1003 this 12 months, proper?
Peter Nielsen — Chief Govt Officer and Chief Monetary Officer
That’s our purpose. We lastly — let me simply once more give the background colour on that. What has slowed us down? We’ve executed every thing for that. We simply have that closing second species tox research to do. And to do this, we have now to have our PK research out there. Once more particular for that, with the ability to reveal that in actual fact you have got drug substance within the animal. We have now 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 some evaluation.
The molecule has a considerably decrease melting level than the opposite two and we predict that it will not be sturdy sufficient for the chemical additions and steps that go to whenever you get a plasma from an animal that may’t face 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 have now one now. And actually, this previous two weeks, we’ve been interviewing some massive CROs which have a suitable technique and so they don’t have a lot of a backlog, which is nice on their mass spec facet of the enterprise that you should use with this system. And so we predict 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 predict 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 expertise 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 Govt 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 Govt Officer and Chief Monetary Officer
Thanks once more everybody for becoming a member of us and in your continued assist of Bio-Path. Have an incredible day. Thanks.
Operator
[Operator Closing Remarks]