Q3 2024 Arcturus Therapeutics Holdings Inc Earnings Call

In This Article:

Participants

Neda Safarzadeh; Vice President - Head of Investor Relations, Public Relations and Marketing; Arcturus Therapeutics Holdings Inc

Joseph Payne; President, Chief Executive Officer, Director; Arcturus Therapeutics Holdings Inc

Andrew Sassine; Chief Financial Officer, Director; Arcturus Therapeutics Holdings Inc

Padmanabh Chivukula; Chief Operating Officer, Chief Scientific Officer; Arcturus Therapeutics Holdings Inc

Lili Nsongo; Analyst; Leerink Partners

Unidentified Participant

Whitney Ijem; Analyst; Canaccord Genuity

Evan Wang; Analyst; Guggenheim Securities

Myles Minter; Analyst; William Blair

Quan Nguyen; Analyst; Wells Fargo

Samantha Schafer; Analyst; Cantor Fitzgerald

Thomas Hoffmann; Analyst; HC Wainwright

Yale Jen; Analyst; Laidlaw & Company

Yigal Nochomovitz; Analyst; Citigroup

Presentation

Operator

(Operator Instructions)
Good day, everyone and welcome to today's Arcturus Therapeutics third-quarter 2024 earnings conference call. (Operator Instructions) Please note this call may be recorded, and I will be standing by if you should need any assistance.
It is now my pleasure to turn the conference over to Neda Safarzadeh, Vice President, Head of Investor Relations, Public Relations and Marketing. Please go ahead.

Neda Safarzadeh

Thank you, operator. Good afternoon and welcome to Arcturus Therapeutics quarterly financial update and pipeline progress call. Today's call will be led by Joe Payne, our President and CEO; and Andy Sassine, our CFO; Dr Pad Chivukula, our CSO and COO will join them for the Q&A station.
Before we begin, I would like to remind everyone that the statements made during this call regarding matters that are not historical facts or forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, performance and achievements to differ materially from those expressed or implied by the statement.
Please see the forward-looking statement disclaimer on the company's press release issued earlier today, as well as the risk factors section in our most recent form 10-K and in subsequent filings with the SEC. In addition, any forward-looking statements presents our views only as of the date, such as statements are made. Arcturus specifically disclaims any obligation to update such statements.
And with that, I will now turn the call over to Joe.

Joseph Payne

Thank you, Neda. It's good to be with you again everybody. We look forward to providing our updates today on our quarterly investor call. I will begin my remarks with an update on progress with our vaccine franchise led by KOSTAIVE, our self-amplifying mRNA COVID-19 vaccine. We're thrilled about our recent commercial launch of KOSTAIVE in Japan.
Last month, members of our senior management team including myself had the wonderful opportunity to travel to Japan to be vaccinated with KOSTAIVE in Tokyo. In addition to our team from Arcturus, we shared this experience with senior management from Meiji CSL and ARCALIS. As you can imagine, it was an experience our team will never forget.
In connection with the first sale of our COVID-19 vaccine, Arcturus received a $25 million commercial milestone. On the regulatory front, CSL secures partner in Japan, Meiji Seika Pharma announced earlier this year that they submitted a partial change application for an amendment to the manufacturing and marketing approval of KOSTAIVE to include domestic manufacturing sites in Japan, including ARCALIS. And ARCALIS is Arcturus's manufacturing joint venture in Japan.
When approved, this will allow for Meiji Seika Pharma to begin selling domestically produced KOSTAIVE this season. The European Medicine Agency continues to review the KOSTAIVE marketing authorization application, I've been impressed with how our team has worked diligently with the agency as they reviewed the first potential self-amplifying mRNA product in Europe. The process is near completion with the CHMP opinion expected next month.
As we look forward to achieving marketing approval in the US, we plan to file BLA for KOSTAIVE in the first half of next year which will be supported by positive results from multiple Phase 3 studies. We continue to collect meaningful clinical data for our proprietary next generation STARR mRNA platform.
The company announced today another set of positive Phase 3 results where an ARCT-2303, this is the [monovalent XBB] variant derivative of KOSTAIVE, met all four primary study objectives and key secondary objectives.
The study supports co administration of KOSTAIVE with licensed influenza vaccines. ARCT-2303 demonstrated superior immune response versus ARCT-154 as measured by neutralizing antibodies against Omicron XBB.1.5.6 in terms of geometric mean tighter or GMT ratio and a zero-conversion rate or SCR difference. Co administration of ARCT-2303 and cell based quadrivalent influenza vaccine showed non inferior immune response versus standalone QIV administration. Co administration of ARCT-2303 and QIV also showed non-inferior immune response versus standalone ARCT-2303 administration.
And lastly, co administration of ARCT-2303 and adjuvanted QIV in older adults showed similar responses versus standalone administration of ARCT-2303 and adjuvanted QIV. In September, the company along with our partners, CSL, Seqirus and Meiji announced new 12-month post vaccination data for KOSTAIVE at options 12 for the control of influenza conference.
The results of a head-to-head Phase 3 study demonstrated that KOSTAIVE maintained superior immunogenicity compared to the conventional mRNA vaccine COMIRNATY for up to one year against Wuhan-Hu-1 and Omicron BA.4/5 and certain other variants handed one sixth the dose of the comparator. These results were published in the lancet infectious disease.
Additional Phase 3 data presented at the options conference showed that bivalent KOSTAIVE also known as ARCT-2301 induced superior immunogenicity over conventional bivalent mRNA vaccine COMIRNATY that persisted against key variants up to six months post vaccination.
Now, shifting our attention to our mRNA Therapeutics franchise. Let's begin with an update on ARCT-032 ARCT-032 is an inhaled messenger RNA therapeutic for cystic fibrosis. And it's formulated with Arcturus's lunar delivery technology that differentiates us from our competitors. In September, we received clearance of an investigational new drug application to the US Food and drug administration. The FDA clearance of the IND application enables Arcturus to initiate a Phase 2 multiple ascending dose study to evaluate the safety tolerability and efficacy of ARCT-032 in people with cystic fibrosis.
Our team is actively engaged in onboarding a substantial number of clinical sites to help us in this effort. We are fortunate to be able to be working closely with the CF Foundation in this process. The Phase 2 study is presently screening individuals with CF who do not qualify for or benefit from CFTR modulator medicines due to dysfunctional or absent CFTR protein and or drug intolerance.
This study will allow us to evaluate FEB lung function improvement in individuals with CF. And I'm very pleased to report that the company is on track to share interim Phase 2 proof of concept data for our CF program. In the first half of 2025.
I'll now move on to our ARCT-810 program. This is our Messenger RNA therapeutic candidate for ornithine transcarbamylase or OTC deficiency. Earlier this year, Arcturus announced the expansion of the Phase 2 clinical program of ARCT-810 into the United States. This open label multiple dose study evaluating pharmacodynamics and safety is currently enrolling adults and adolescents requiring clinical management for OTC deficiency.
Our placebo-controlled Phase 2 European study has completed the dosing phase. So these concurrent Phase 2 studies in Europe and the US will allow us to evaluate meaningful biomarker changes in individuals with OTC deficiency. And I'm happy to report that the company is on track to share interim Phase 2 proof of concept data in the first half of 2025.
With that, I'll now pass the call to Andy.

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