PBLA - Earnings call transcript Q2 2024 | Panbela Therapeutics, Inc.

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Operator

[Audio Gap] earnings call. [Operator Instructions] It is now my pleasure to turn the floor over to your host, James Carbonara of Investor Relations. Sir, the floor is yours.

James Carbonara

Thank you, operator.

Joining me on today's call are Jennifer Simpson, Chief Executive Officer; and Sue Horvath, Chief Financial Officer.

note historical made forward-looking facts please that this statements. begin, not are may we that on statements call Before be considered materially detailed in Risks results company's filings implied could that SEC. the such from the differ by are and or those statements cause forward-looking with expressed uncertainties to actual on call revise only does obligation update or as undertake forward-looking not today's date, Any any this statements of of these statements. any made company speak and the to circumstances. or events future reflect to

over to With company's will that, the call please I Simpson. Jennifer ahead. Simpson, the Dr. turn CEO, go

Jennifer Simpson

open us. you, will our . Beginning Q&A. thank Thank recent Then results trial. and you Phase up James, our program, with we review development today's all achievements ASPIRE discussing the for by call will global joining upcoming clinical milestones. financial Sue I for call and III our start our clinical before

SBP-XXX that third or with were with ivospemin, safety without June in untreated evaluating the Data recommended modification, or study marking review. pancreatic continuation positive DSMB, and patients excited ductal metastatic is in adenocarcinoma. We Safety Monitoring the nab-paclitaxel announce for Board, consecutive combination Aspire independent to gemcitabine

patients At November reached XXX XXX database that XX, that had we compared to XXXX. time, safety patients shared the on

approximately XXXX. proceeding quarter in patients ASPIRE first January, of As sites you may to recall, initially the enrollment faster surpassed be by of anticipated. and enrolling, XXX the for we enrollment expectation full XX%, actively than completed open all With reiterate our

due events initially for half announced With trial occurred. middle interim regimen, than ASPIRE to analysis the occur the median before encouraging in be the a Consequently, XXXX April, gemcitabine and which for conducted. ductal benefit interim analysis relatively less of the expected can modest suggesting now total the approval metastatic survival interim potential death respect of XX% to that to in of XXXX death data, [indiscernible] X.X-month the treating FDA's or expected interim nab-paclitaxel. to This the compared development of ASPIRE early follows ivospemin is trial's had we prolonged event the improvement in requires the primarily patients pancreatic survival, projected the or analysis required adenocarcinoma. of demonstrated In overall

remains metastatic care XX still survival milestone, months, need of pancreatic underscoring critical SBP-XXX, regulatory approved median this of believe benefits regimen nab-paclitaxel outperform therapies. of cancer effective to ASPIRE and for treatment. incremental promise. prognosis this indications that or grim With holds with the suggesting the recently with the combined Despite under gemcitabine context, trial we ivospemin, early potential standard In the more

metastatic an ivospemin Given regulatory anticipate approval. eagerly the landscape the commitment in it to current landscape that facing treatment the FDA for pancreatic signal favorably which QX results in expect we position interim this may study formidable XXXX, remains steadfast turning for could in disease. of awaits its company cancer, the this a transformative The in we and efficacy potential patients point

a continue consensus its adnomanous plan with Our program progress polyposis EMA optimize and value. FAP global reaching community. we FAP the plan, exploring commitment remains we the FDA, work on to strategies to advancing the as strong closely familial to program, Upon while to a registration or this

and III are a study second [indiscernible] Regarding prevention for enrollment investigating high-risk of concluded. colorectal Phase trial, has the the PACES adenoma pleased we cancers, primary

previously data the [indiscernible] to through treated X the event readout has half by conducted reduce the stages This NCI in of successfully the by study study by the futility Oncology for Group, second supported colorectal XXXX. the analysis, of passing adenomas cancers X-year the cancer. second X potential rate With or land in expect we primary Southwest SWOG, and patients

obtained neuroblastoma program. in studies. from place sale the additional $XXX,XXX the monetization April, of sales the eflornithine additional received II assets Phase from U.S. In later to of saw milestones pediatric in focus an Shifting years. we We

December, approval first [indiscernible] secured representing reaches polymene-targeted worth US positioned approval further receive to NDA in reiterating for that FDA payments. It's As [indiscernible] is of FDA key the approval WorldMeds US WorldMeds milestones, for its validate cancer financial only as but Panbela This we benefits in role therapy provides other progress therapy also polymenes potential our serves the not continue cancer to to programs. a indication. in of to

X:X our open in participating conducted diabetes supported actively also X of by which the under enrolling of a and to have We are School and Medicine recruiting multicenter with a interim is a II ratio, Phase analysis double-blind, metastatic with patients. randomization castration-resistant year. patients agreement take trial expected study now trial and centers into prostate The of clinical is type entered eflornithine All X study place cancer, JDRF. for leadership Indiana Phase an placebo-controlled University II eflornithine next

Medicine year. Furthermore, this we in which University cancer, to Phase the planning a we ivospemin of in aim trial to during in half latter are of the assess process platinum-resistant ovarian of collaboration with Hopkins II Johns School initiate

April to we launch as with Cancer additional a our and In of American Association Research as assess modulators presented The ivospemin polymemetabolism immune ovarian cancer in basis part investigations latter up clinical year. trials this in showcasing Upcoming efficacy Annual modulator the gear we polymimetabolism cancer. ovarian in data are to AACR robust program a offer modulators. designed fact, conjunction encouraging Meeting, in or preclinical a for at ivospemin's the poster for

we development, I have Phase X programs. In

the of Our trial initiate this our in Last, neoadjuvant year. is look Phase and with pancreatic half second for we and I/II stick looking We in initiating screening non-small Center clinical a patients. collaboration patient open the to this enrolling II cell front, investigator-initiated the cancer to and XX year Moffit Phase forward first XXXX. are lung mutant on Cancer trial

we program research efforts. Cancer commitment preclinical addition to of bispecific and to preclinical are an initiative are antibodies stage this investigate and T Center This benefits is also preclinical therapy potential Anderson clinical programs, goal progress approaches inhibitor treatment to collaborating in using our clinical The In polymene our the innovative monoclonal cell models. development of metabolic demonstrates our exploring cancer complements treatment. on we combining CAR primary with ongoing making work project. with to MD our Currently,

gastric trial in results we were premalignant in eflornithine Latin excited Additionally, at conference. Phase and patients our incidence Week presented Disease of IIa that Cancer oral University Vanderbilt National collaborators the Institute. by efficacy high a at The Digestive the of with Medical of clinical the Center titled highlighted presentation the the conditions areas placebo-controlled, in announce of safety randomized recent findings June, America, funded Evaluation to

findings study of pathway targeting patients infection-associated reduced term treatment. cancer, long cancer. in for particularly prevention DNA eflornithine, and the the that our tolerated of and treatment The developing gastric safe, in component underscore both well potential key high pain risk for demonstrated damage after a completing These with pathway approach with polymine of patients

We through area. are collaboration progress forward look and our made with the this to further thrilled in this research advancing

patient projected for of interim ovarian cell quarter XXXX, completion the trial, our include: the the milestones III IIb the cancer as obtaining Phase trial, final SAP; the neoadjuvant first in second half cancer trial data, Phase In clinical a lung FDA for of feedback survival analysis trial enrollment. of first trial, the metastatic and and in Phase global publishing in I the II ASPIRE registration opening our overall we enrolling as anticipate Phase in XXXX our XXXX trial well summary, non-small opening the pancreatic pancreatic EMA

have Panbela. year-to-date look creation XXXX. strives and quarter second progress and to forward We significant continued in marked clinical for development value The

our I over Sue now Sue? discuss to call will the turn to financial results.

Susan Horvath

QX million lower a due of increased . Net Thank in compared prior fees expenses enrollment loss $X in administrative was in million million in QX million up or of $XXX.XX expenses development quarter, $X.XX net due loss $X.X XXXX. per was were the legal share of per $X.X compensation primarily year diluted in and of General million noncash million QX XXXX, you, for XXXX. the Jennifer. to XXXX. XXXX trial. to from compared to and and were diluted mainly of expenses share QX or $X.X Research in quarter $X.X the decrease $X.X ASPIRE The approximately approximately in lower to

was amendment agreed agreement give payments with to US X the approximately the On second the of April WorldMeds, future to payment potential with in future XX, signed nonrefundable associated $X.X million for exchange milestones. company XXXX, company a up an company is the Per payments the reflected million. if milestones remaining at other achieved quarter. of $X.X signing total amendment for This and income the non-dilutive are by approximately the in received is the potential payment amended terms,

end. Total $X.X million. and million approximately by $X.X cash was $XX,XXX. consisting deposits were at as assets June primarily $XX.X Noncurrent XXXX, Total of of were XX, were quarter current [indiscernible] assets found current liabilities million cash

capitalization. our Regarding

reserved shares As After we of reserved June XX, outstanding. shares fully million share shares. XX.XX X.XX our was approximately for million issued approximately common had including options count and warrants, XXXX, and

The national by the included listing term were the the payable amount the organization X Pursuant The in remains to the contract OTCQB balance. $XX.X ended for Cash totaled ASPIRE expenses on and obtained increase common CPP, for million. WorldMeds PBLA. the for used loan net for a company our operations symbol the with July US payment to research loan by loan loss of stock X the from proceeds Panbela's for on a LLC. XXXX, in agreement owed company's used accounts $X.X owned in fees Cash pursuing used offset XXXX, a in lender of company its the its quotation securities subsidiary, original entered an agreement, exchange. million. company the of new the XX, stock eligible the operations our common into loan XX, June primarily trial. under approximately is principal company months On wholly and a months,

Operator, take we questions. are now ready to

Operator

is Your H.C. Instructions] from Pantginis Joe from question [Operator coming first Wainwright.

Joshua Korsen

on for Joe. is Josh This

So were clinical in was question ideally if like about status pediatric with had anything of to give us the that? the relation U.S. wondering current there neuroblastoma that WorldMeds I like updates program. status a I about any the you could or program development just

Jennifer Simpson

in has done believe, the that was have Group setting, there in approval So I that been Enrollments, setting. the trial first-line trial maintenance through they run Oncology the now. is in Children's a FDA

letting course. it's now So just run the its trial

have anything of that WorldMeds would probably more to they are year. and but in last So commercializing terms actively indication they have was in of directed do that, US approved approval, be December that to an that than

Operator

Q&A That [Operator concludes Everyone, today's our session. this event. completes Instructions]

for participation. wonderful may disconnect have Thank at You time, you this a and your day.

Panbela Therapeutics (PBLA) 13 Aug 242024 Q2 Earnings call transcript