On May 10, 2023 Aravive, Inc. (Nasdaq: ARAV, "the Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported first quarter 2023 financial results and provided corporate updates (Press release, Aravive, MAY 10, 2023, View Source [SID1234631342]).

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"During the first quarter, we continued to make progress in the development of batiraxcept in ovarian, kidney and pancreatic cancer as well as strengthened our management team," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "We remain on track to deliver topline results from our platinum-resistant ovarian cancer (PROC) Phase 3 trial in mid-2023 and, if successful, plan to submit a Biologics License Application (BLA) by the end of 2023. We are also looking forward to presenting updated data from our clear cell renal cell carcinoma (ccRCC) trial at ASCO (Free ASCO Whitepaper) in June. Finally, we were excited to welcome Carolina Petrini as our Chief Commercial Officer and are already leveraging her expertise ahead of the PROC Phase 3 data readout."

Recent Corporate Highlights

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The Phase 3 AXLerate-OC Trial in PROC Completed Enrollment; On Track for Topline Data Mid-2023
The registration-directed Phase 3 trial of batiraxcept plus paclitaxel for PROC completed enrollment in January 2023. The trial planned to enroll 350 patients with platinum resistant, high-grade serous ovarian cancer who have received 1-4 prior lines of therapy. CMC work remains on track and the Company expects to report topline data from the trial by mid-2023. If successful, the Company plans to submit a BLA by year-end 2023. The global, randomized, double-blind, placebo-controlled Phase 3 trial is evaluating efficacy and tolerability of 15 mg/kg batiraxcept in combination with paclitaxel versus placebo in combination with paclitaxel.

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Advancing Commercial Readiness with Appointment of Carolina Petrini as Chief Commercial Officer

On April 11, 2023, the Company announced the appointment of Carolina Petrini as Chief Commercial Officer. Ms. Petrini brings over two decades of experience in developing pre-commercial, launch readiness and commercial strategies, building and leading high-performing commercial teams.
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Presented Promising ccRCC Data at the 2023 ASCO (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium; Updated Data to be Presented at ASCO (Free ASCO Whitepaper) 2023
The Company presented a poster at the 2023 ASCO (Free ASCO Whitepaper) GU Cancers Symposium in February 2023 featuring updated results from its ongoing Phase 1b/2 trial of batiraxcept in ccRCC. To date, batiraxcept demonstrates a favorable safety profile in previously treated ccRCC patients. Efficacy results suggest that batiraxcept has a greater impact on patients previously treated with IO and VEGF-TKI.

The open-label Phase 2 portion of the clinical trial initiated January 31, 2022 and is expected to enroll 55 patients across three parts. Part A is expected to enroll approximately 25 patients and investigate 15 mg/kg batiraxcept in combination with cabozantinib in 2L+ ccRCC patients. Part B is expected to enroll approximately 20 patients and evaluate 15 mg/kg batiraxcept in combination with nivolumab and cabozantinib as a potential front-line treatment for ccRCC. Part C is expected to evaluate 15 mg/kg batiraxcept monotherapy in approximately 10 patients with ccRCC who are not eligible for curative intent therapies.

The Company will present updated data from the P1b portion and preliminary data from the P2 portion of the ccRCC trial in a poster presentation at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting.

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Batiraxcept Granted FDA Orphan Drug Designation in Pancreatic Cancer

In February 2023, the Company announced that the FDA granted batiraxcept Orphan Drug Designation (ODD) for the treatment of pancreatic cancer. Based on the favorable safety and tolerability data reported to date, the Company intends to dose an additional 6-18 patients at higher doses (20 mg/kg and potentially 25 mg/kg) to assess whether a higher dose will increase the proportion of patients whose batiraxcept blood levels will be above the model-informed minimal efficacious concentration and increase the clinical activity of batiraxcept in combination with gemcitabine plus nab-paclitaxel. Preliminary data from the 20 mg/kg cohort is expected in the second half of 2023.

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Preclinical Batiraxcept Data in Bile Duct Cancer Published in the Peer-reviewed Journal Cancers

In March 2023, preclinical results from a study of batiraxcept in bile duct cancer were published in the peer-reviewed journal Cancers. In the study, data showed that tumor tissues from bile duct cancer patients had significantly higher AXL expression compared to normal liver tissues, which correlated with metastasis and poor survival rates, suggesting that AXL is a potential therapeutic target in biliary cancer. In in vitro and in vivo models of bile duct cancer, batiraxcept demonstrated a significant anti-tumor effect, reducing tumor growth, invasion and metastatic burden, highlighting its potential for clinical development in high AXL-expressing bile duct cancers. The article entitled, "Targeting AXL Using the AVB-500 Soluble Receptor and through Genetic Knockdown Inhibits Bile Duct Cancer Growth and Metastasis" the article can be found at the Company website.

First Quarter 2023 Financial Results

Revenue for the three months ended March 31, 2023 was $1.5 million, compared with $1.1 million for the same period in 2022. Revenues were derived solely from our collaboration and license agreement with 3D Medicines, executed in November 2020, to develop and commercialize batiraxcept in oncology indications in China. Revenues represent 1) a portion of initial signing and milestone recorded from 3D Medicines that is recognized at the time it is probable the milestone will be met and 2) a portion of the milestone that is deferred and recognized over the PROC trial period.

Total operating expenses for the three months ended March 31, 2023 were $19.4 million, compared with $16.1 million for the same period in 2022. Research and development expenses for the three months ended March 31, 2023 were $15.9 million, compared with $13.0 million for the same period in 2022. Non-cash stock-based compensation for the three months ended March 31, 2023 was $0.7 million, compared with $0.6 million for the same period in 2022.

For the three months ended March 31, 2023 the Company recognized an expense for the increase in the fair value of the warrant liability in the amount of $33.2 million, compared to a gain of $1.2 million for the same period a year ago.

For the three months ended March 31, 2023, Aravive reported a net loss of $50.0 million, or $0.66 per share, compared to a net loss of $13.1 million, or $0.62 per share, for the same period in 2022. The majority of the net loss for the three months ended March 31, 2023 is attributable to the change in fair value of the warrant liability of $33.2 million. Operating loss for the three months ended March 31, 2023 was $17.9 million, compared to the operating loss from operations of $15.0 million for the same period in 2022.

Cash Position

As of March 31, 2023, cash and cash equivalents were $35.9 million, compared to $53.7 million as of December 31, 2022. The Company anticipates that its current cash and cash equivalents will fund operating plans into the fourth quarter of 2023.