On August 11, 2022 Aravive, Inc. (Nasdaq: ARAV, "the Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported financial results for the second quarter ended June 30, 2022 and provided corporate updates (Press release, Aravive, AUG 11, 2022, View Source [SID1234618145]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continued to achieve great progress for Aravive in the second quarter of 2022. All of our batiraxcept clinical trials for the treatment of ovarian, kidney and pancreatic cancers continued to advance at a strong pace," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "We remain on track with our lead Phase 3 registrational study in ovarian cancer to complete enrollment around year-end 2022, which would enable us to read out topline data mid-2023 and potentially file a BLA with the FDA by year-end 2023."

"We continue to successfully enroll patients in our Phase 2 trial of batiraxcept in clear cell renal cancer and will have updates throughout the remainder of this year. Our Phase 1b trial in pancreatic cancer has completed enrollment and updated results are anticipated later this year. We remain confident in the execution of our clinical trials and encouraged by the continued signals of the potential therapeutic success of batiraxcept."

"Finally, we hired two industry seasoned veterans to round out our senior management team. Rudy Howard and Dr. Robert Geller will not only add tremendous support as we continue our trials, but also as we potentially move towards and beyond regulatory approval of a commercially viable portfolio."

Recent Corporate Highlights

Batiraxcept in Platinum Resistant Ovarian Cancer (PROC): The registration-directed Phase 3 program of batiraxcept in combination with paclitaxel in PROC remains on track to complete enrollment around year-end 2022. The Company expects to report topline data from the trial by mid-2023. CMC work remains on track with the goal of filing a BLA by year-end 2023. The global, randomized, double-blind, placebo-controlled Phase 3 trial is evaluating efficacy and tolerability of batiraxcept at a dose of 15 mg/kg in combination with paclitaxel versus placebo in combination with paclitaxel. The trial aims to enroll 350 patients with platinum resistant, high-grade serous ovarian cancer who have received 1-4 prior lines of therapy.
Batiraxcept in Clear Cell Renal Cell Carcinoma (ccRCC) and Serum-Based Biomarker: As of April 30, 2022 and as presented during the KOL symposium, 26 previously treated (2L+) patients with ccRCC were treated with batiraxcept in the Phase 1b portion of the trial at doses of 15 mg/kg (n=16) and 20 mg/kg (n=10), plus cabozantinib 60 mg daily. There were no dose limiting toxicities observed at either dose and 14 of the 26 patients remained on study. The best overall response rate (ORR, confirmed + unconfirmed) in the ITT population was 46% and 50% in patients dosed with 15 mg/kg (the recommended Phase 2 dose). One of the objectives of the ongoing Phase 1b/2 ccRCC trial is to evaluate the correlation of baseline serum soluble AXL (sAXL)/GAS6 (biomarker) with radiographic response in patients with ccRCC treated with batiraxcept plus cabozantinib. The best ORR in the biomarker high population was 60%, and 67% in the biomarker high population dosed at 15 mg/kg. The 7-month progression-free survival (PFS) rate was 71% in the ITT population, 83% in the biomarker high population, and 91% in the 15 mg/kg biomarker high group. Eight patients experienced resolution of one or more target lesions. The Company has discussed a registrational path with the US FDA that includes use of the sAXL/Gas6 ratio as a basis for an accelerated approval. The Company is on track to report updated results from the Phase 1b and Phase 2 portions of the trial in the second half of 2022.
Batiraxcept in Pancreatic Adenocarcinoma: As of May 3, 2022 and as discussed at the KOL symposium, 21 patients with advanced or metastatic pancreatic adenocarcinoma have been treated with 15 mg/kg batiraxcept in combination with gemcitabine and nab-paclitaxel as a first-line treatment. Batiraxcept has been generally well-tolerated with no unexpected safety signals. The best ORR (confirmed + unconfirmed) was 29%. As noted with the other programs, an observable correlation of baseline levels of serum soluble AXL (sAXL)/GAS6 (biomarker) to clinical activity was noted in this trial and the best ORR in the biomarker high population was 40%. Five patients experienced resolution of one or more target lesions; however, two of these patients have since progressed. The Company is on track to report additional updated data from the Phase 1b portion of the trial in the second half of 2022.
Second Quarter 2022 Financial Results
Revenues for the three months ended June 30, 2022 were $1.6 million, compared to $1.1 million for the three months ended March 31, 2022. Revenues were derived solely from the Company’s collaboration and license agreement with 3D Medicines, executed in November 2020 to develop and commercialize batiraxcept in oncology indications in Greater China. Revenues represent 1) a portion of initial signing and milestone payments received from 3D Medicines that is recognized at the time of the receipt and 2) a portion of the payments that is deferred and recognized over the PROC trial period. The increase in revenues is attributable to increased expenditures related to the PROC trial which drives the recognition of deferred payments over the PROC trial period.

Total operating expenses for the three months ended June 30, 2022 were $21.0 million, compared to $16.1 million for the three months ended March 31, 2022. Research and development expense for the three months ended June 30, 2022 was $17.3 million, compared to $13.0 million for the three months ended March 31, 2022. The increase in research and development expense is attributable to the continued progression of the Company’s PROC and ccRCC clinical trials, as well as increases in related CMC costs. General and administrative expense for the three months ended June 30, 2022 was $3.7 million, compared to $3.1 million for the three months ended March 31, 2022. The increase in general and administrative expense is attributable to increased stock-based compensation, increased consulting fees, and severance expense.

Aravive reported a net loss of $18.5 million, or $0.61 per share, for the three months ended June 30, 2022, compared to a net loss of $13.1 million, or $0.62 per share, for the three months ended March 31, 2022.

Cash Position
As of June 30, 2022, cash and cash equivalents were $46.8 million, compared to $65.8 million as of March 31, 2022 and $59.4 million as of December 31, 2021. The Company anticipates that its current cash and cash equivalents will fund its operating plans into the first quarter of 2023.