On May 12, 2022 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, reported that the company management team, along with guest key opinion leaders (KOLs), will provide an update for the investment community on Thursday, June 2nd at 4:30 PM (Press release, Aptose Biosciences, MAY 12, 2022, View Source [SID1234614316]). The event will include an up-to-date review of clinical data available for Aptose’s two investigational products under development for hematologic malignancies: HM43239, an oral, myeloid kinome inhibitor in an international Phase 1/2 trial in patients with relapsed or refractory acute myeloid leukemia (AML); and luxeptinib, an oral, dual lymphoid and myeloid kinome inhibitor in a Phase 1 a/b trial in patients with relapsed or refractory B-cell malignancies, and in a separate Phase 1 a/b trial in patients with relapsed or refractory AML or high risk myelodysplastic syndrome (MDS).

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The slides will be available on Aptose’s website here and a recording of the presentation will be archived shortly after the conclusion of the event.

Separately, preclinical data for HM43239 also will be presented in a poster at the EHA (Free EHA Whitepaper)2022 Hybrid Congress, to be held in Vienna, Austria June 9 – 17, 2022 and virtually. The accepted abstract is being published today, Thursday, May 12th at 16:00 CEST / 10:00 AM ET.

On May 12, 2022 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of chronic viral infections, cancer, and other serious diseases, reported financial results for the first quarter ended March 31, 2022 and provided a business update (Press release, Silverback Therapeutics, MAY 12, 2022, View Source [SID1234614333]).

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"In the first quarter of 2022, we have made significant progress in advancing the preclinical development of SBT8230, a first-in-class antibody-drug conjugate that we believe has the potential to drive functional cure in patients with chronic hepatitis B (cHBV) by eliciting a liver-localized anti-viral response," said Laura Shawver, Ph.D., chief executive officer of Silverback. "We believe that activating the immune response is an important component of a functional cure and may be combined with treatments that target the HBV life cycle to improve durability. Our team is on track to complete a regulatory submission in the fourth quarter of 2022, enabling the planned initiation of the single ascending dose healthy volunteer cohort of the Phase 1 study in the first quarter of 2023. We plan to report data from this cohort in the second half of 2023."

SBT8230 (ASGR1-TLR8 ImmunoTAC conjugate for chronic HBV)

Initiated Phase 1-enabling toxicology study for SBT8230 in the first quarter of 2022 and on track to complete Phase 1 regulatory submission in the fourth quarter of 2022. Silverback expects to open enrollment for the single ascending dose healthy volunteer cohort of the Phase 1 study in the first quarter of 2023 and anticipates reporting data from this portion of the study in the second half of 2023. SBT8230 is comprised of an ASGR1 monoclonal antibody conjugated to a TLR8 linker-payload. ASGR1 is highly expressed in liver and is restricted in its expression to this organ. SBT8230 is designed to elicit a liver-localized anti-viral immune response and has the potential to improve the therapeutic window observed with untargeted, orally administered TLR8 agonists in cHBV, which have shown promise preclinically, but have been limited by toxicities in the clinic associated with immune activation in the gastrointestinal tract.
ImmunoTAC Discovery Programs

Silverback continues to advance discovery programs, with an update anticipated in the fourth quarter of 2022. Discovery efforts are focused on evaluating and developing new antigen binding domains specific for targets of interest (including antibodies), next-generation linker technologies, and both agonist and antagonist small molecule payloads, that may be combined to create novel tissue-targeted antibody conjugates.
First Quarter Financial Results

For the first quarter ended March 31, 2022, Silverback reported a net loss of $24.6 million, compared to a net loss of $18.9 million for the comparable period in 2021.

Research and development expenses for the first quarter ended March 31, 2022 were $16.9 million, compared to $12.2 million for the same period in 2021. The increase in the Company’s research and development expenses in 2022 were primarily attributable to an increase in direct costs related to preclinical research efforts, including the Company’s SBT8230 program, and increases in personnel-related expenses as operations grew in support of program advances.

General and administrative expenses for the first quarter ended March 31, 2022 were $7.8 million, compared to $6.6 million for the same period in 2021. The increase in general and administrative expenses in 2022 were primarily attributable to an increase in personnel-related expenses, including increases in salaries, bonuses, and stock-based compensation. The increase in general and administrative expenses in 2022 was also due to an increase in legal fees, professional fees, and other various general and administrative expenses as we now operate as a public company.

As of March 31, 2022, Silverback reported cash, cash equivalents, and investments of $298.1 million, compared to $319.1 million at December 31, 2021, which is expected to fund operating expenses and capital expenditure requirements into the second half of 2026. As of March 31, 2022, Silverback had 35,145,281 shares of common stock outstanding.

On May 12, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported its financial results for the quarter ended March 31, 2022 and provided a business update (Press release, Sellas Life Sciences, MAY 12, 2022, View Source [SID1234614350]).

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"SELLAS achieved several key milestones in the first four months of 2022, including expanding our development pipeline and strengthening our balance sheet," said Angelos Stergiou, M.D., Sc.D. h.c., President and Chief Executive Officer of SELLAS. "We entered into an exclusive license agreement with GenFleet Therapeutics (Shanghai), Inc. ("GenFleet") granting us exclusive rights for the development and commercialization of GFH009, a highly selective and potentially first and best in class small molecule cyclin-dependent kinase 9 ("CDK9") inhibitor, across all therapeutic and diagnostic uses worldwide outside of Greater China. We believe that GFH009 is a complementary strategic fit to our overall clinical development plans and provides us with an opportunity to further advance into the market for acute myeloid leukemia ("AML") therapeutics. GFH009 affords us the potential to treat active AML disease while our lead clinical candidate, galinpepimut-S (GPS), is potentially used in the maintenance setting in AML. The in-license of GFH009 also provides us an opportunity to address a very important pediatric market of soft tissue sarcomas as well as other cancers."

Dr. Stergiou added, "During the first quarter, we continued to advance the Phase 3 REGAL trial for our lead asset, GPS and, in April, we also launched an expanded access program for GPS in response to multiple requests from physicians with which we hope to potentially improve clinical outcomes for patients and their families. Subsequent to the quarter, we fortified SELLAS’ balance sheet with the closing of a public offering with gross proceeds of $25 million. The funds position us to advance our clinical programs for both GPS and GFH009. We are pleased by the progress we made over the first quarter of 2022 and remain steadfast in our mission to develop innovative treatments and improve the standard of care available to patients. With GPS and GFH009, we now have two significant clinical assets in our pipeline, with several opportunities to develop and potentially commercialize, cancer drugs that can prolong the lives of patients battling cancer."

Pipeline Updates:

Galinpepimut-S (GPS)
Expanded Access Program: In April 2022, the Company launched a pre-approval access/expanded access program ("EAP") with SELLAS’ lead asset, GPS, for treating patients suffering from AML. For more information on the GPS EAP, please visit the PIPELINE page at www.sellaslifesciences.com.

Phase 3 REGAL Study: SELLAS continued to progress enrollment of patients and activation of additional sites in the United States, Europe, and Asia in the first quarter of 2022. The Company believes that enrollment for the REGAL study will be completed in late 2022 or early in the first quarter of 2023 and the planned interim analysis will occur by the end of the first half of 2023, provided that its statistical assumptions and assumptions regarding the impact of COVID-19 on the operations of clinical sites as well as the duration of the pandemic remain unchanged.

Phase 1/2 GPS Study in Combination with Merck’s KEYTRUDA: In February 2022, the Company completed enrollment in the Phase 1/2 clinical trial of GPS in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in second or third line Wilms Tumor-1 (WT1+) relapsed or refractory metastatic ovarian cancer. Data from 15 patients is currently being reviewed by SELLAS and Merck, with top-line results expected by mid-2022 and a final data analysis for all evaluable patients expected by the end of 2022.

Phase I GPS Study in China: In March 2022, an IND application to initiate the first clinical trial in China for GPS was approved by China’s National Medical Products Administration ("NMPA"), which triggered a milestone payment of $1 million received by the Company in May 2022. The IND, for a small Phase 1 clinical trial investigating safety, was submitted by SELLAS’ partner in China, 3D Medicines Inc. ("3D Medicines"), with 3D Medicines expecting to initiate the trial by mid-2022. 3D Medicines’ current clinical development plan provides for initiation of a Phase 2 clinical trial following receipt of satisfactory safety data from the Phase 1 clinical trial; the initiation of the Phase 2 clinical trial will also trigger a milestone payment to SELLAS.

New Patent Allowance: In February 2022, the U.S. Patent and Trademark Office issued a Notice of Allowance for a patent application covering certain WT1-targeting peptides, in combination with other molecules such as other peptides and immunomodulating compounds, useful for treatment of WT1-expressing cancers. The patent application covers WT1-targeting peptides linked to other molecules and is expected to be granted later this year. The patent will have a term extending to at least 2026. This patent complements the Company’s existing composition of matter patents covering GPS peptides which expire in 2033 not including any potential extensions.
GFH009
In-License: On March 31, 2022 the Company announced it had entered into an exclusive license agreement with GenFleet Therapeutics (Shanghai), Inc. ("GenFleet"), that grants rights to SELLAS for the development and commercialization of GFH009, a highly selective small molecule CDK9 inhibitor, across all therapeutic and diagnostic uses worldwide outside of Greater China (mainland China, Hong Kong, Macau and Taiwan). CDK9 activity has shown a negative correlation with overall survival in a number of cancer types, including hematologic cancers, such as AML and lymphomas, as well as solid cancers, such as osteosarcoma, pediatric soft tissue sarcomas, and melanoma, and endometrial, lung, prostate, breast and ovarian cancer.

Ongoing Phase 1 Clinical Trial: In April 2022, SELLAS announced that initial data from the first four dose levels of the ongoing Phase 1 dose-escalating clinical trial of GFH009 show a significant anti-leukemic effect at the 9mg and 15mg dose levels given twice a week in AML patients resistant to standard-of-care treatments, with two patients refractory to, or relapsed after, venetoclax treatment experiencing greater or equal to a 50 percent decrease in bone marrow blasts following GFH009 monotherapy. There have been no dose-limiting toxicities, including no grade 3/4 neutropenia (an abnormally low count of a type of white blood cells), in the first four dose levels (2.5mg, 4.5mg, 9mg and 15 mg) with the twice-weekly GFH009 dosing. The first AML patient has been enrolled in the fifth dose level (22.5mg twice a week) cohort. The last planned dose level in this clinical trial is 30mg.
Corporate Highlights:

Underwritten Public Offering: On April 5, 2022, the Company consummated an underwritten public offering providing gross proceeds to the Company of $25.0 million, before deducting underwriting discounts and commissions and offering expenses.

Bolstered Leadership Team: In March 2022, SELLAS appointed Robert Francomano as Chief Commercial Officer. In January 2022, the Company promoted John Burns to Senior Vice President, Finance, and Chief Accounting Officer.
Settlement of Legacy Galena Litigations: In February 2022, SELLAS received the final court approval of the settlement of securities litigation relating to the Company’s predecessor, Galena. This marked the end to all litigation related to activities of Galena.
Financial Results for the First Quarter 2022:

Licensing revenue: Licensing revenue for the first quarter of 2022 was $1.0 million, as compared to $5.7 million for the same period in 2021. Licensing revenue in the first quarter of 2022 was related to China’s NMPA approval of an IND application by 3D Medicines and licensing revenue during the first quarter of 2021 was related to the initial transaction price of the license agreement with 3D Medicines, which was recognized over a period of time.

R&D Expenses: Research and development expenses for the first quarter of 2022 were $4.6 million, as compared to $4.3 million for the same period in 2021. The increase was primarily due to an increase in clinical trial expenses for the ongoing Phase 3 clinical trial of GPS in AML and personnel related expenses due to increased headcount, partially offset by a decrease in manufacturing expenses due to the timing of the manufacture of registration batches of GPS in the prior year.

Acquired In-Process Research and Development: Acquired in-process research and development for the first quarter 2022 was $10.0 million, related to the in-licensing of GFH009. There was no acquired in-process research and development during the first quarter of 2021.

G&A Expenses: General and administrative expenses for the first quarter of 2022 were $3.0 million, as compared to $3.6 million for the same period in 2022. The decrease was primarily due to a decrease in amortization expense associated with the capitalized contract acquisition costs of the 3D Medicines license agreement and a decrease in professional service fees, partially offset by an increase in personnel related expenses due to increased headcount.

Net Loss: Net loss was $16.7 million for the first quarter of 2022, or a basic and diluted loss per share of $1.05, as compared to a net loss of $2.4 million for the same period in 2021, or a basic and diluted loss per share of $0.16.

Cash Position: As of March 31, 2022, cash and cash equivalents totaled approximately $14.3 million. Subsequent to March 31, 2022, the Company consummated an underwritten public offering providing gross proceeds to the Company of $25.0 million, before deducting underwriting discounts and commissions and offering expenses, and received a $1.0 million milestone payment from 3D Medicines.

On May 12, 2022 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company developing the next generation of therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported its financial results for the quarter ended March 31, 2022 and provided a business update (Press release, Phio Pharmaceuticals, MAY 12, 2022, View Source [SID1234614369]).

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"We are pleased enrollment is open for our first-in-human clinical trial for PH-762 at the Gustave Roussy Institute, one of the largest cancer centers in Europe. This study will evaluate the safety, tolerability, pharmacokinetics and checkpoint anti-tumor activity of PH-762 in a neoadjuvant setting in subjects with advanced melanoma. The clinical study will feature a dose escalation of PH-762 with top-line data from the first group of patients expected in the first quarter of 2023," said Dr. Geert Cauwenbergh, Principal Executive Officer of Phio. "In addition, the new preclinical data we recently presented at the AACR (Free AACR Whitepaper) Annual Meeting shows the potential of PH-894 to be used in treating patients who do not respond to anti-PD-1 therapy, or patients who progress after initially responding to treatment with checkpoint inhibitors. The reaction of the investment community when this data was presented, reinforces the relevance of a compound like PH-894, an INTASYL compound specifically targeting BRD4, in patients who may not respond or relapse after PD-1 therapy. We expect to finalize IND-enabling studies for PH-894 in the second half of 2022," concluded Dr. Cauwenbergh.

Quarter in Review and Recent Corporate Updates

Enrollment open for the Company’s Phase 1b clinical study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of PH-762 in a neoadjuvant setting in subjects with advanced melanoma.
Presented new in vivo data at the AACR (Free AACR Whitepaper) Annual Meeting 2022 that provide a strong rationale for the clinical use of PH-894, a BRD4-targeting, self-delivering RNAi, as a monotherapy, as well as in combination with systemic PD-1 therapy.
Continue to develop PH-3861, a dual-targeting INTASYL towards PD-1 and BRD4. Last year this program reported data that show PH-3861 elicited complete cure of tumors in an in vivo hepatoma model and outperformed the efficacy of the small molecule and antibody control treatments toward the same targets. In addition, local INTASYL therapy was shown to induce a systemic anti-tumor response with clearance of untreated distal tumors.
Upcoming Pipeline Milestones

Expect to finalize IND-enabling studies for PH-894 in the second half of 2022.
On track to report top-line data from the first group of patients with advanced melanoma in the clinical trial for PH-762 in the first quarter of 2023.
Additional data publications on the Company’s pipeline programs.
Financial Results

Cash Position

At March 31, 2022, the Company had cash of $20.5 million as compared with $24.1 million at December 31, 2021. The Company expects its current cash will be sufficient to fund currently planned operations to the second quarter of 2023.

Research and Development Expenses

Research and development expenses were approximately $1.6 million for the quarter ended March 31, 2022, compared with approximately $2.4 million for the quarter ended March 31, 2021. The decrease was primarily due to the preclinical studies and manufacturing costs to support the Company’s clinical trial with PH-762, which were completed in the prior year period, offset by increases in CRO costs in preparation for the start of the Company’s clinical trial with PH-762 and personnel-related expenses due to an increase in headcount as compared to the prior year period.

General and Administrative Expenses

General and administrative expenses were approximately $1.1 million for the quarter ended March 31, 2022, compared with approximately $1.2 million for the quarter ended March 31, 2021. The decrease was primarily due to decreases in legal and patent fees offset by an increase in stock-based compensation expense.

Net Loss

Net loss was $2.6 million, or $0.19 per share, for the quarter ended March 31, 2022, compared with $3.4 million, or $0.32 per share, for the quarter ended March 31, 2021. The decrease in net loss was primarily attributable to the decrease in research and development expenses as described above.

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.