On May 12, 2022 BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported an exclusive license with Bristol Myers Squibb to develop and commercialize BBP-398, a potentially best-in-class SHP2 inhibitor, in oncology (Press release, BridgeBio, MAY 12, 2022, View Source [SID1234614388]).

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Under the terms of the agreement, BridgeBio will receive an upfront payment of $90 million, up to $815 million in development, regulatory and sales milestone payments, and tiered royalties in the low- to mid-teens. BridgeBio will retain the option to acquire higher royalties in the United States in connection with funding a portion of development costs upon the initiation of registrational studies.

Based on the terms of the agreement, BridgeBio will continue to lead its ongoing Phase 1 monotherapy and combination therapy trials. Bristol Myers Squibb will lead and fund all other development and commercial activities.

"We are grateful to be expanding our collaboration with Bristol Myers Squibb, a leader in oncology, and we believe this agreement will allow us to reach even more patients with difficult-to-treat cancers. We believe our SHP2 inhibitor has the potential to be a best-in-class agent given the data we have seen, and we are eager to see our monotherapy and combination trials progress in collaboration with our partners at Bristol Myers Squibb," said Neil Kumar, Ph.D., founder and CEO of BridgeBio.

SHP2 is a protein-tyrosine phosphatase that links growth factor, cytokine and integrin signaling with the downstream RAS/MAPK pathway to regulate cellular proliferation and survival. Overactivity of SHP2 is a critical contributor to many forms of cancer, is a mechanism of resistance to several targeted therapies, and can suppress antitumor immunity.

"We have seen the potential role SHP2 inhibition could play in unlocking possible combination therapies to treat patients suffering from a range of cancers. We are hopeful this collaboration with BridgeBio will help us maximize the possibilities SHP2 inhibition with BBP-398 will hold for patients," said Rupert Vessey, M.A., B.M., B.Ch., FRCP, D.Phil., Executive Vice President, Research & Early Development, Bristol Myers Squibb.

In July 2021, BridgeBio initially announced a non-exclusive, co-funded clinical collaboration with Bristol Myers Squibb to evaluate the combination of BBP-398 with OPDIVO (nivolumab) in patients with advanced solid tumors with KRAS mutations. BridgeBio is currently advancing its Phase 1 clinical trial in patients with solid tumors driven by mutations in the MAPK signaling pathway, including RAS and receptor tyrosine kinase genes.

OPDIVO is a trademark of Bristol-Myers Squibb Company.

About BBP-398
BBP-398 is a SHP2 inhibitor that is being developed for difficult-to-treat cancers and was founded through a collaboration with The University of Texas MD Anderson Cancer Center’s Therapeutics Discovery division. BridgeBio has a strategic collaboration with LianBio for clinical development and commercialization of BBP-398 in combination with various agents in solid tumors such as non-small cell lung cancer, colorectal and pancreatic cancer, in mainland China and other major Asian markets and clinical collaborations; with Bristol Myers Squibb for combination with OPDIVO (nivolumab) in patients with advanced solid tumors with KRAS mutations; and with Amgen for combination with LUMAKRAS (sotorasib), Amgen’s KRASG12C inhibitor, in patients with advanced solid tumors with KRASG12C mutations.

On May 12, 2022 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, Decibel Therapeutics, MAY 12, 2022, View Source [SID1234614387]).

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"2022 is slated to be a year of important growth and execution for Decibel as we have multiple catalysts expected throughout the remainder of the year. We have built a strong foundation both operationally and scientifically and are looking forward to these significant milestones, which potentially can further validate Decibel’s inner ear expertise and commitment to further exploiting our proprietary gene therapy platform," said Laurence Reid, Ph.D., Chief Executive Officer of Decibel. "Notably, we plan to share data from an interim analysis of our Phase 1b trial of DB-020 for cisplatin-induced hearing loss in the second quarter of 2022, and we intend to initiate a Phase 1/2 clinical trial of DB-OTO later this year, subject to regulatory clearance."

Pipeline Highlights and Upcoming Milestones:

Gene Therapies for Congenital, Monogenic Hearing Loss

DB-OTO Program Remains On Track For 2022 Milestones: Decibel remains on track to submit an investigational new drug application (IND) to the U.S. Food and Drug Administration and/or a Clinical Trial Application (CTA) in Europe for DB-OTO in 2022. Decibel also anticipates the initiation of a Phase 1/2 clinical trial of DB-OTO for pediatric patients with congenital hearing loss due to an otoferlin deficiency in 2022, subject to regulatory clearance.
Presented New Preclinical Data from Four Gene Therapy Programs at the 45th Annual Association for Research in Otolaryngology Conference (ARO): In February 2022, Decibel presented preclinical data highlighting the identification of proprietary, cell-selective promoters for three of its gene therapy pipeline programs deployed from its platform, in addition to new DB-OTO data, which further characterized expression of otoferlin over time following DB-OTO administration in mice and non-human primates. These findings are consistent with the expression previously reported in mice that achieved stable functional recovery. Additionally, functional recovery and tolerability data associated with DB-OTO dosing over a 10-fold dose range in mice was observed. Decibel is developing DB-OTO in collaboration with Regeneron Pharmaceuticals and retains global commercial rights to DB-OTO.
On Track to Identify a Product Candidate for AAV.103 Program in 2022: Product candidate selection for the AAV.103 program to restore hearing to individuals with a gap junction beta-2 (GJB2) deficiency, the most common cause of autosomal recessive, non-syndromic, congenital hearing loss, is expected in 2022. Decibel is developing AAV.103 in collaboration with Regeneron Pharmaceuticals and retains global commercial rights to the AAV.103 program.
Otoprotection Therapeutic

Phase 1b Proof-of-Concept Trial of DB-020 for the Treatment of Cisplatin-Induced Hearing Loss Interim Results Anticipated in the Second Quarter of 2022: Results of the interim analysis from the ongoing Phase 1b clinical trial of DB-020 in patients with cisplatin-induced hearing loss, a serious and debilitating condition for which there are no approved therapies, are expected in the second quarter of 2022. Cisplatin, a commonly used chemotherapy agent, is known to cause hearing loss, tinnitus and speech recognition difficulty. DB-020 is comprised of a proprietary formulation of sodium thiosulfate that has been optimized for delivery to the ear. DB-020 is designed to protect hearing without interfering with cisplatin’s anti-cancer activity by locally disabling cisplatin in the cochlea.
First Quarter 2022 Financial Results:

Cash Position: As of March 31, 2022, cash, cash equivalents and available-for-sale securities were $139.4 million, compared to $162.3 million as of December 31, 2021.
Research and Development Expenses: Research and development expenses were $7.5 million for the first quarter of 2022, compared to $6.0 million for the same period in 2021. The increase in research and development expenses for the first quarter of 2022 was primarily due to higher development costs incurred to advance the DB-OTO and DB-020 programs, as well as higher personnel-related costs due to increased headcount, wages and stock-based compensation.
General and Administrative Expenses: General and administrative expenses were $6.6 million for the first quarter of 2022, compared to $4.9 million for the same period in 2021. The increase in general and administrative expenses for the first quarter of 2022 was primarily due to higher professional fees including external consulting, advisory and audit services, as well as higher personnel-related costs due to increased headcount, wages and stock-based compensation.
Financial Guidance:

Based on its current operating and development plans, Decibel believes that its existing cash, cash equivalents and available-for-sale securities will fund its pipeline programs and operating expenses into 2024.

On May 12, 2022 Theseus Pharmaceuticals, Inc. (NASDAQ: THRX) (Theseus or the Company), a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients through the discovery, development and commercialization of transformative targeted therapies, reported business highlights and reported financial results for the first quarter ended March 31, 2022 (Press release, Theseus Pharmaceuticals, MAY 12, 2022, View Source [SID1234614386]).

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"We are pleased by the progress achieved in the first quarter of 2022 as we continue to make strides in advancing our pipeline of novel pan-variant targeted therapies. Notably, we began the year by enrolling patients in our first clinical trial of THE-630 in advanced GIST, and more recently presented encouraging preclinical data on our EGFR program at AACR (Free AACR Whitepaper) that support our approach of pan-variant inhibition in a single molecule," said Tim Clackson, Ph.D., President and Chief Executive Officer of Theseus. "Over the next 12 months we have a robust set of milestones, including the nomination of a development candidate for our EGFR program and the expansion of our pipeline with a third TKI program. We look forward to seeing these developments over the remainder of 2022, and to sharing initial clinical data from THE-630 in the first half of 2023."

Recent Business Highlights and Upcoming Milestones:

Enrollment ongoing in Phase 1/2 clinical trial evaluating THE-630, targeting the receptor tyrosine kinase KIT, in patients with advanced GIST. In January 2022, the first patient was treated in a Phase 1/2 dose escalation and expansion clinical trial of THE-630 in patients with advanced GIST, a disease that remains largely KIT-dependent even after multiple lines of therapy. THE-630 is a single molecule pan-variant inhibitor of KIT, designed for patients whose cancer has developed resistance to earlier lines of therapy. The Company continues activating sites and enrolling patients in this study, with initial data from the Phase 1 portion of the clinical trial expected to be presented at a scientific conference in the first half of 2023.

Presented preclinical data supporting nomination of a development candidate for fourth-generation EGFR program, expected in the third quarter of 2022. At the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April, Theseus presented preclinical data demonstrating that pan-variant inhibition of all major single-, double-, and triple-EGFR mutants, including T790M and C797S, with selectivity over wild-type and central nervous system (CNS) penetration, can be achieved with a single molecule. Theseus expects to nominate a fourth-generation EGFR inhibitor designed to inhibit the full range of EGFR variants found in the tumors of patients with EGFR-mutant NSCLC that have developed C797S-mediated resistance to first- or later-line osimertinib treatment. Additional preclinical data on the development candidate are expected to be presented at a scientific conference in the fourth quarter of 2022 and Theseus expects to submit an IND for this program in 2023.

Additional TKI program expected to be disclosed by year-end 2022. Theseus continues advancing its preclinical discovery pipeline and expects to introduce a new kinase target program by the end of 2022.

Continued to strengthen leadership team. Theseus recently appointed Claire Coleman, Ph.D., as Vice President, Program Management. Dr. Coleman joined the Company from Allena Pharmaceuticals, where she served as Executive Director, Program Management, and earlier in scientific and program management roles of increasing responsibility at Momenta Pharmaceuticals. She will play an integral role in shepherding Theseus’ programs through preclinical and clinical-stage development.
First Quarter Financial Results:

Cash Position: As of March 31, 2022, Theseus had cash, cash equivalents and short-term and long-term investments of $237.0 million. Theseus expects its cash, cash equivalents, and investments to fund operations and capital expenditures into the second half of 2024 based on its current operating plan.

R&D Expenses: Research and development expenses were $6.5 million for the first quarter of 2022, as compared to $3.8 million for the same period in 2021. This increase was primarily due to $1.8 million of increased employee-related costs, and $0.8 million in increased expenses for clinical and preclinical studies.

G&A Expenses: General and administrative expenses were $4.0 million for the first quarter of 2022, as compared to $0.7 million for the same period in 2021. This increase was primarily due to $2.1 million of increased employee-related costs, as well as $1.1 million of increased general expenses, primarily driven by public company-related costs.

Net Loss: Net loss was $10.5 million for the first quarter of 2022, as compared to a net loss of $4.5 million for the same period in 2021.

On May 12, 2022 Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, reported financial results for the first quarter ended March 31, 2022 (Press release, Applied Therapeutics, MAY 12, 2022, View Source [SID1234614385]).

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"We made significant progress in the first quarter across all three of our Phase 3 programs," said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics. "We are pleased to have reached alignment with the FDA on Galactosemia, and are excited about the expected milestones in the year ahead."

Recent Highlights

Provided Regulatory Update on Galactosemia Program. In January 2022, the Company announced that the FDA would require clinical outcomes data for approval. Clinical outcomes are assessed in the pediatric clinical study every 6 months by a firewalled committee until the study reaches statistical significance. The Company met with the FDA in April 2022, and the FDA confirmed that the pediatric study as it is currently designed would support an NDA submission if statistical significance is reached. The 6-month clinical outcomes were assessed by the firewalled data monitoring committee, and it was determined that the safety/benefit profile supports continuing the study. The next committee evaluation will be following completion of the 12-month clinical outcomes assessments.

Presented Data on AT-007 Treatment in SORD Deficiency at the 2022 Annual Meeting of the Peripheral Nerve Society. In May 2022, the Company presented data highlighting the effect of AT-007 treatment on sorbitol levels. In a pilot study in patients with Sorbitol Dehydrogenase (SORD) Deficiency, sorbitol level correlated with disease severity, and AT-007 treatment substantially reduced sorbitol levels. In a Drosophila model of disease, elevated sorbitol resulted in neuronal damage and decline in mobility, and AT-007 treatment prevented the disease phenotype by inhibiting sorbitol production. Taken together, this data significantly advances the understanding of the disease and potential for treatment with AT-007.

Presented Data on Galactosemia Disease Progression at the 2022 43rd Annual Meeting of the Society for Inherited Metabolic Disorders. In April 2022, the Company presented data featuring baseline disease characteristics of 47 pediatric patients with Classic Galactosemia, illustrating the high burden of disease associated with Galactosemia, including neurological complications, due to high galactitol levels. In addition, data presented at the meeting illustrated that higher galactitol levels, but not higher Gal-1p levels, were associated with greater disease severity overall and on each of the four quadrants of central nervous system (CNS) function. Together, these data underscore the urgent need to bring a treatment to people living with Galactosemia.

Presented Data on Galactosemia Disease Progression at the 2022 Annual Clinical Genetics Meeting of the American College of Medical Genetics and Genomics. In March 2022, the Company presented data featuring the first therapeutic interventional clinical trial in pediatric patients with Classic Galactosemia, demonstrating that AT-007 significantly reduces toxic galactitol in ACTION-Galactosemia children.
Financial Results

Cash and cash equivalents and short-term investments totaled $55.7 million as of March 31, 2022, compared with $80.8 million at December 31, 2021.

Research and development expenses for the three months ended March 31, 2022 were $15.0 million, compared to $14.4 million for the three months ended March 31, 2021. The increase of $0.6 million was primarily due to an increase in clinical and pre-clinical expense of $5.1 million, primarily related to the progression of the SORD pivotal trial, progression of the AT-007 ACTION-Galactosemia long-term extension adult study, and progression of the AT-007 ACTION-Galactosemia Kids pediatric registrational study; an increase in personnel expenses of $0.8 million due to the increase in headcount in support of our clinical program pipeline; an increase in regulatory and other expenses of $0.2 million; an increase in stock-based compensation of $0.1 million due to new stock option and restricted stock grants; and offset by a decrease in drug manufacturing and formulation costs of $5.6 million primarily related to the completion and release of AT-001 and AT-007 drug product batches in the three months ended March 31, 2021.

General and administrative expenses were $8.1 million for the three months ended March 31, 2022, compared to $9.8 million for the three months ended March 31, 2021. The decrease of $1.7 million was due to a decrease in commercial expenses of $0.6 million related to a decrease in spend relating to commercial operations; a decrease in other expenses of $0.3 million relating to decreased costs of other office expenses; a decrease in stock-based compensation of $1.0 million relating to options being forfeited during the current period; a decrease in legal and professional fees of $0.2 million due to lower external legal fees; offset by an increase in personnel expenses of $0.2 million related to an increase in headcount; and an increase in insurance expenses of $0.1 million related to increased insurance costs.

Net loss for the first quarter of 2022 was $23.1 million, or $0.88 per basic and diluted common share, compared to a net loss of $24.2 million, or $1.00 per basic and diluted common share, for the first quarter 2021.

On May 12, 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 first quarter ended March 31, 2022 and provided corporate updates (Press release, Aravive, MAY 12, 2022, View Source [SID1234614384]).

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"During the first quarter we continued to advance the development of batiraxcept for the potential treatment of ovarian, kidney and pancreatic cancer, successfully raised additional capital and strengthened the management team," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "Our registrational Phase 3 trial of batiraxcept in ovarian cancer continues on pace to complete enrollment in 2022, with top line data anticipated in 2Q’23 and a potential BLA filing with the FDA in 4Q’23. Our ongoing Phase 2 trial of batiraxcept in clear cell renal cell carcinoma also continues to successfully enroll patients across three cohorts and the Phase 1b trial of batiraxcept in pancreatic cancer completed enrollment in 1Q’22. Updated results are anticipated throughout 2022. We remain encouraged by the continued signals of best-in-class potential of batiraxcept and look forward to providing continued clinical updates on each of our three active programs throughout 2022."

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 in 2H’22. Topline data from the trial is anticipated to be available in 2Q’23. CMC work related to the PROC program remains on track with the goal of filing a BLA in 4Q’23. 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 platinum resistant, high-grade serous ovarian cancer patients who have received 1-4 prior lines of therapy.

Batiraxcept in Clear Cell Renal Cell Carcinoma (ccRCC) and Serum-Based Biomarker: The Company dosed first patient in the Phase 2 study of batiraxcept in combination with cabozantinib in 2L+ ccRCC trial in January 2022. Enrollment across the three patient cohorts of the Phase 2 study continues on pace for planned completion and updated data releases during 2Q’22. The Company anticipates providing clinical updates on the Phase 2 study throughout 2022. In March 2022, the Company announced new biomarker data from the Phase 1b portion of the trial in patients with ccRCC. Aravive had previously reported an observable correlation of baseline levels of serum soluble AXL (sAXL)/GAS6 to clinical activity in its Phase 1b PROC trial. As such, one of the objectives of the ongoing Phase 1b/2 ccRCC trial is to evaluate the correlation of baseline sAXL/GAS6 with radiographic response in patients with ccRCC treated with batiraxcept plus cabozantinib. The Company continues to engage the US FDA about utilizing the biomarker as a basis for an accelerated development strategy. Updated biomarker data is anticipated in 2022.

As of April 30, 2022, 26 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 in previously treated (2L+) patients with ccRCC. There were no dose limiting toxicities observed at either dose and 14 of the 26 patients remain 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). 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 is on track to report additional updated results from the Phase 1b portion of the trial in the second quarter of 2022.

Batiraxcept in Pancreatic Adenocarcinoma: In January 2022, Aravive completed enrollment of the Phase 1b portion of its Phase 1b/2 trial of batiraxcept in combination with gemcitabine and nab-paclitaxel as a first-line treatment in patients with advanced or metastatic pancreatic adenocarcinoma who are eligible to receive gemcitabine and nab-paclitaxel combination therapy. As of May 3, 2022, 21 patients 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 to clinical activity was noted in this trial as well and the best ORR in the biomarker high population was 40%. Five patients experienced resolution of one or more target lesions; however, 2 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 quarter of 2022.
Strengthened Balance Sheet: In January 2022, Aravive raised approximately $10.0 million from the sale of a pre-funded warrant to purchase 4,545,455 shares of the company’s common stock to Eshelman Ventures, LLC at a price of $2.20 per share, which was the consolidated closing bid price of the company’s common stock on The Nasdaq Global Select Market on December 31, 2021. Additionally, Fred Eshelman, Pharm.D., was appointed the Executive Chairman of Aravive, having served as the Non-Executive Chairman of the board since April 2020. In March 2022, the Company raised an additional approximately $10.0 million from the sale of common stock and a pre-funded warrant for an aggregate of a combination of 4,850,241 shares of the company’s common stock and pre-funded warrants to a single healthcare-focused institutional investor and Eshelman Ventures, LLC and issued warrants to purchase an additional aggregate of 4,850,241 shares of common stock in a registered direct offering priced at-the-market under Nasdaq rules. Combined, the additional capital infusions strengthen the Company’s financial position and fund operations as currently planned into 1Q’23.
First Quarter 2022 Financial Results
Revenue for the three months ended March 31, 2022 was $1.1 million compared with $0.3 million for the same period in 2021. 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 a portion of initial signing and milestone payments received from 3D Medicines that is recognized at the time of the receipt and a portion of the payments that is deferred and recognized over the PROC trial period.

Total operating expenses for the three months ended March 31, 2022 were $16.1 million compared with $8.3 million for the same period in 2021. Total operating expenses for the three months ended March 31, 2022 included non-cash stock-based compensation expense of $0.6 million, compared to $0.5 million for the same period in 2021.

For the three months ended March 31, 2022, Aravive reported a net loss of $13.1 million, or $0.62 per share compared to a net loss of $8.0 million, or $0.44 per share for the same period in 2021.

Cash Position
As of March 31, 2022, cash and cash equivalents were $65.8 million, compared to $59.4 million as of December 31, 2021. In January 2022, Aravive announced an approximately $10.0 million investment by Eshelman Ventures and in March 2022, Aravive announced an additional approximately $10 million investment by a healthcare-focused institutional investor and Eshelman Ventures, LLC. The company anticipates that its current cash and cash equivalents will fund operating plans into 1Q’23.