On May 9, 2024 Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) reported financial results for its fiscal 2024 second quarter ended March 31, 2024 (Press release, Arrowhead Pharmaceuticals, MAY 9, 2024, View Source [SID1234643041]). The Company is hosting a conference call today, May 9, 2024, at 4:30 p.m. ET to discuss the results.
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Christopher Anzalone, Ph.D., President and CEO at Arrowhead, said: "Arrowhead has achieved significant progress across our broad pipeline of investigational RNAi-based medicines that leverage the proprietary TRiMTM platform and we continued to strengthen our focus on and investment in our late-stage cardiometabolic programs. As we approach completion of the PALISADE Phase 3 study of plozasiran and initiate additional Phase 3 trials of both plozasiran and zodasiran, we will continue to efficiently execute our clinical studies. Simultaneously, we plan to begin the regulatory submission process, refine our commercial strategy, and build the commercial infrastructure to support it."
Webcast and Conference Call and Details
Investors may access a live audio webcast on the Company’s website at View Source A replay of the webcast will be available approximately two hours after the conclusion of the call.
For analysts that wish to participate in the conference call, please register at https://register.vevent.com/register/BIf9305354ec6b44e3b3e946792a393a5e. Once registered, you will receive the dial-in number and a personalized PIN code that will be required to access the call.
Selected Recent Events
Received a $50 million milestone payment from Royalty Pharma plc, which was paid in the third quarter of fiscal 2024, following the completion of enrollment of the Phase 3 OCEAN(a) – Outcomes Trial of olpasiran, being conducted by Amgen. Olpasiran, a small interfering RNA originally developed by Arrowhead using its proprietary Targeted RNAi Molecule (TRiMTM) platform, is designed to lower levels of lipoprotein(a), a genetically determined risk factor for cardiovascular disease.
Presented final data from the Phase 2 SHASTA-2 study of investigational plozasiran in patients with severe hypertriglyceridemia in a late-breaking oral presentation at the American College of Cardiology 73rd Annual Scientific Session & Expo and simultaneously published in the journal JAMA Cardiology. Key results included the following:
Treatment with plozasiran led to dose-dependent placebo-adjusted reductions in triglycerides (primary endpoint) of -49% (P < 0.001), -53% (P < 0.001), and -57% (P < 0.001), driven by placebo-adjusted reductions in APOC3 of -68% (P < 0.001), -72% (P < 0.001), and -77% (P < 0.001) at week 24, after receiving two doses of 10 mg, 25 mg, and 50 mg plozasiran, respectively. Mean maximum, non-placebo adjusted reductions from baseline in triglycerides and APOC3 were up to 86% and 90% and typically occurred around week 16 or week 20.
Among patients treated with plozasiran, 90.6% achieved a triglyceride level less than 500 mg/dL, the level associated with increased risk of acute pancreatitis, at week 24. In addition, 48.4% of patients achieved normal triglyceride levels of less than 150 mg/dL at week 24.
Subjects treated with plozasiran also showed improvements in multiple atherogenic lipid and lipoprotein levels, including remnant cholesterol, HDL-cholesterol, and non-HDL cholesterol.
Plozasiran demonstrated a favorable safety profile in the SHASTA-2 study. The adverse event and serious adverse event profile were similar across treatment groups. Observed adverse events generally reflected the comorbidities and underlying conditions of the study population.
Initiated an Expanded Access Program (EAP) to make investigational plozasiran available outside of a clinical trial for patients with familial chylomicronemia syndrome (FCS) who meet certain program eligibility criteria.
The plozasiran EAP is for individuals living with FCS. As with any investigational medicine that has not been approved by regulatory authorities, investigational plozasiran may or may not be effective in treating your diagnosis or condition, and there may be risks associated with its use. If you are a patient or caregiver wishing to know more about this plozasiran EAP for FCS, please discuss this EAP and all treatment options with your treating physician. If you are a treating physician and are seeking information about the plozasiran EAP or would like to request access for a patient, please contact [email protected].
Launched the 2024 Summer Series of R&D webinars to highlight specific therapeutic areas in Arrowhead’s pipeline. Each event will feature presentations by Arrowhead team members and external key opinion leaders, who will discuss the respective disease areas and treatment landscapes. 2024 Summer Series Schedule:
May 23, 2024 – Muscular
June 25, 2024 – Cardiometabolic
July 16, 2024 – Pulmonary
August 15, 2024 – Obesity/Metabolic
September 25, 2024 – Central Nervous System
Dosed the first subjects in a Phase 1/2a clinical trial (NCT06209177) of ARO-CFB, designed to reduce hepatic expression of complement factor B, and is being developed as a potential treatment for diseases associated with activation of the complement pathway.
Dosed the first subjects in a Phase 1/2a clinical trial (NCT06138743) of ARO-DM1, designed to reduce expression of the dystrophia myotonica protein kinase gene in the muscle, and is being developed as a potential treatment for type 1 myotonic dystrophy, the most common adult-onset muscular dystrophy.
Strengthened the balance sheet through an underwritten registered offering of common stock for gross proceeds of approximately $450 million, before deducting underwriting discounts, commissions, and other offering expenses payable by the company.
Selected Fiscal 2024 Second Quarter Financial Results
ARROWHEAD PHARMACEUTICALS, INC.
CONSOLIDATED CONDENSED FINANCIAL INFORMATION
(in thousands, except per share amounts)
OPERATING SUMMARY
Three Months Ended
March 31,
2024
2023
(unaudited)
Revenue
$
–
$
146,267
Operating Expenses:
Research and development
101,122
74,881
General and administrative expenses
25,069
23,221
Total operating expenses
126,191
98,102
Operating (loss) income
(126,191
)
48,165
Total other expense
(805
)
(489
)
(Loss) income before income tax expense and noncontrolling interest
(126,996
)
47,676
Income tax expense
–
Net (loss) income including noncontrolling interest
(126,996
)
47,676
Net (loss) income attributable to noncontrolling interest, net of tax
(1,696
)
(999
)
Net (loss) income attributable to Arrowhead Pharmaceuticals, Inc.
$
(125,300
)
$
48,675
Net (loss) income per share attributable to Arrowhead Pharmaceuticals, Inc. – Diluted
$
(1.02
)
$
0.45
Weighted-average shares used in calculating – Diluted
123,285
108,143
FINANCIAL POSITION SUMMARY
March 31, 2024
September 30, 2023
(unaudited)
Cash, cash equivalents and restricted cash
$
127,704
$
110,891
Investments
395,410
292,735
Total cash resources (cash and investments)
523,114
403,626
Other assets
432,036
361,926
Total Assets
$
955,150
$
765,552
Current deferred revenue
$
–
$
866
Other liabilities
459,745
477,524
Total Liabilities
$
459,745
$
478,390
Total Arrowhead Pharmaceuticals, Inc. Stockholders’ Equity
$
483,794
$
271,343
Noncontrolling Interest
11,611
15,819
Total Noncontrolling Interest and Stockholders’ Equity
$
495,405
$
287,162
Total Liabilities, Noncontrolling Interest and Stockholders’ Equity
$
955,150
$
765,552
Shares Outstanding
124,133
107,312