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]).

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"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.

On August 11, 2022 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, reported it will release its unaudited financial results for the quarter ended June 30, 2022 on Tuesday, August 16, 2022, before the US markets open (Press release, BioLineRx, AUG 11, 2022, View Source [SID1234618144]).

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The Company will host a conference call on Tuesday, August 16, 2022 at 10:00 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

To dial into the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until August 18, 2022; please dial +1-888-295-2634 from the U.S. or +972-3-925-5904 internationally.

On August 11, 2022 Cardinal Health (NYSE: CAH) today reported fourth quarter fiscal year 2022 revenues of $47.1 billion, an increase of 11% from the fourth quarter of last year (Press release, Cardinal Health, AUG 11, 2022, View Source [SID1234618143]). GAAP operating earnings were $36 million, primarily due to a non-cash, pre-tax goodwill impairment charge of $303 million in the Medical segment. GAAP diluted earnings per share (EPS) were $0.50, primarily due to this impairment, net of tax effects. Non-GAAP operating earnings increased 41% to $450 million, primarily due to the increase in Pharmaceutical segment profit, and non-GAAP diluted EPS increased 36% to $1.05 in the quarter .

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Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. (PRNewsfoto/Cardinal Health)

Fiscal year 2022 revenues were $181.4 billion, a 12% increase from fiscal year 2021. GAAP operating loss was $596 million due to non-cash, pre-tax goodwill impairment charges of $2.1 billion in the Medical segment. GAAP diluted loss per share was $3.35, primarily due to these impairments, net of tax effects. Non-GAAP operating earnings decreased 12% to $2.0 billion, primarily due to net inflationary impacts and global supply chain constraints in the Medical segment. Non-GAAP diluted EPS decreased 9% to $5.06 due to the decline in Medical segment profit, partially offset by an increase in Pharmaceutical segment profit, net of tax effects.

"In fiscal year 2022, Medical segment performance was significantly impacted by inflation and supply chain constraints," said Mike Kaufmann, CEO of Cardinal Health. "In addition, the Pharmaceutical segment grew 5% and we generated strong cash flow, returning $1.6 billion to our shareholders through share repurchases and dividends."

Jason Hollar, CFO of Cardinal Health, said, "Looking forward, we have confidence in our Medical Improvement Plan and our long-term targets for growth. We remain committed to the essential role our company plays in healthcare and to delivering value for our customers, employees, and investors."

Fourth-quarter revenue for the Medical segment decreased 11% to $3.8 billion, due to the divestiture of the Cordis business and lower products and distribution volumes.

Medical segment loss of $16 million in the fourth quarter was primarily due to net inflationary impacts and global supply chain constraints in products and distribution. Additionally, the favorable comparison to the prior year PPE inventory reserve was offset by a lower contribution from PPE and the divestiture of the Cordis business.

Long-term financial targets

The company reiterated its long-term targets of low to mid-single digit segment profit growth in the Pharmaceutical segment, mid to high-single digit segment profit growth in the Medical segment, and to average a double-digit combined Non-GAAP EPS growth and dividend yield. Additionally, the company is targeting Medical segment profit of at least $650 million by fiscal year 2025, based on its Medical Improvement Plan.

Leadership changes

The company separately announced that its Board of Directors has elected Jason Hollar, the company’s current Chief Financial Officer, to serve as its next Chief Executive Officer, effective September 1, 2022. Mr. Hollar will succeed Mike Kaufmann, the company’s CEO since January 2018. Mr. Hollar will also join the company’s Board of Directors. Additionally, Patricia English, the company’s current Chief Accounting Officer, will serve as interim CFO, while the company conducts an external search for a permanent CFO.

Recent highlights

Cardinal Health announced that it has acquired the Bendcare group purchasing organization entity, strengthening Specialty Solutions’ Cornerstone RheumatologyTM GPO as a leading rheumatology-focused GPO. The company also made a minority investment in the Bendcare management services organization.
Cardinal Health announced the addition of a new 208,144 square foot distribution center in the Columbus, Ohio, area as part of a multi-year warehouse modernization and growth plan. The new distribution center will support the company’s at-Home Solutions business, a market-leading medical supplies provider and specialized business focused on providing comfortable care in the home for people with chronic and serious health conditions.
Cardinal Health announced the acquisition of ScalaMed, a smart platform that transfers prescriptions directly to patients via a secure mobile app. The acquisition transfers ScalaMed’s technology and assets to Outcomes, a Cardinal Health company.
Cardinal Health hosted its 30th annual Retail Business Conference with more than 4,000 customers in attendance, representing 3,000 unique independent community pharmacies, highlighting the company’s innovations and demonstrating its commitment to customers.
Cardinal Health, along with pharmaceutical distribution peers, reached an agreement with the State of Oklahoma to resolve opioid-related claims. If that and the previously announced agreement with the State of Washington are finalized, 48 of 49 eligible states will be subject to the previously disclosed broad settlement agreement. Additionally, the distributors reached an agreement to settle the opioid-related claims of the majority of West Virginia subdivisions.
Cardinal Health Board of Directors approved a quarterly dividend of $0.4957 per share out of the company’s capital surplus. The dividend will be payable on October 15, 2022 to shareholders of record at the close of business on October 3, 2022.
Upcoming webcasted investor events

Morgan Stanley 20th Annual Global Healthcare Conference at 10:00am EST, September 13, 2022
Webcast

Cardinal Health will host a webcast today at 8:30 a.m. Eastern to discuss fourth quarter and full year results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required.

Presentation slides and a webcast replay will be available until August 10, 2023.

On August 11, 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 June 30, 2022 and provided a business update (Press release, Phio Pharmaceuticals, AUG 11, 2022, View Source [SID1234618142]).

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"We are pleased to have initiated our first-in-human clinical trial of PH-762, while maintaining our spending in the first half of the year. This clinical trial evaluates the safety, tolerability, pharmacokinetics and checkpoint anti-tumor activity of PH-762 in a neoadjuvant setting in subjects with advanced melanoma. This 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. "We look forward to achieving a number of milestones during the second half of 2022, including the planned initiation of our first clinical trial in ACT with PH-762 in partnership with AgonOx, Inc. This trial will evaluate the safety, tolerability and efficacy of DP TILs treated with PH-762 in subjects with advanced metastatic melanoma. We also continue to generate promising new data for our preclinical programs, both in collaboration with our partners and on our own. We expect to present these new data during several presentations at major conferences in the second half of this year."

Quarter in Review and Recent Corporate Updates

Initiated dosing of subjects and enrollment ongoing in a 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 preclinical data at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting which show silencing BRD4 with PH-894, a self-delivering RNAi INTASYL compound, can be used to improve the characteristics of CAR-T cell products during the activation and expansion phases of the cell manufacturing process.
Presented a trial-in-progress poster describing the study outline of a Phase 1b clinical trial of PH-762, a self-delivering RNAi targeting PD-1, for the treatment of advanced melanoma at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. As there is currently no neoadjuvant standard of care for resectable advanced melanoma patients, neoadjuvant treatment with PH-762 provides an alternative therapeutic option to treat these patients.
Upcoming Pipeline Milestones

Plans to initiate a clinical trial evaluating the use of PH-762 and DP TILs in ACT during the fourth quarter of 2022 in partnership with AgonOx, Inc.
Expects to finalize IND-enabling studies for PH-894 in the second half of 2022.
Expects to report top-line data from the first group of subjects 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 June 30, 2022, the Company had cash of $18.0 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 fourth quarter of 2023.

Research and Development Expenses

Research and development expenses decreased 16% to approximately $1.3 million for the quarter ended June 30, 2022, compared with approximately $1.6 million for the quarter ended June 30, 2021. The decrease in research and development expenses was primarily due to the completion of the preclinical studies with PH-762 required for the Company’s clinical trial as a direct therapeutic and the manufacturing costs of PH-894 in the prior year period offset by an increase in personnel-related expenses as a result of a higher headcount.

General and Administrative Expenses

General and administrative expenses increased 8% to approximately $1.2 million for the quarter ended June 30, 2022, compared with approximately $1.1 million for the quarter ended June 30, 2021. The increase in general and administrative expenses was primarily due to a total net increase in payroll and executive search-related expenses as a result of the departure of the Company’s CEO.

Net Loss

Net loss decreased 6% to approximately $2.5 million, or $0.19 per share, for the quarter ended June 30, 2022, compared with $2.7 million, or $0.20 per share, for the quarter ended June 30, 2021. The decrease in net loss was primarily attributable to the decrease in research and development, which was partially offset by an increase in general and administrative expenses as described above.

For the six months ended June 30, 2022, the Company saw a decrease of 15% in net loss to approximately $5.2 million, or $0.38 per share, compared with approximately $6.1 million, or $0.50 per share, for the six months ended June 30, 2021. The decrease in net loss was primarily attributable to a decrease in research and development expenses driven by the completion of the preclinical studies with PH-762 required for the Company’s clinical trial as a direct therapeutic and the manufacturing costs for PH-762 and PH-894 offset by an increase in personnel-related expenses as a result of a higher headcount and increased third-party professional service fees as the Company prepared for and began its clinical trial with PH-762.

About PH-762

PH-762 activates immune cells to better recognize and kill cancer cells. It does so by reducing the expression of PD-1, a clinically validated target for immunotherapy. PD-1 is expressed by T cells and prevents them from killing cancer cells. When PH-762 reduces PD-1 expression, the "brakes" on the immune system are released and activates the T cells to kill the cancer cells. PH-762 is being developed as a standalone drug therapy with local intratumoral administration to a tumor. In addition, it is also being developed as a critical component of cellular immunotherapy, more specifically to improve tumor cell killing capability of adoptively transferred tumor infiltrating lymphocyte (TIL) therapy.

About PH-894

PH-894 silences the epigenetic protein BRD4, which is an intracellular regulator of gene expression that impacts cell differentiation, and hence, cell function. Like other epigenetic targets, BRD4 is a protein that has been shown to be difficult to target with current drug modalities. Since BRD4 is an intracellular protein, antibody therapies cannot be used and small molecule inhibitors tested to date typically lack the required specificity. PH-894 is being developed as a standalone drug therapy with local intratumoral administration to a tumor. In addition, it is also being developed as a critical component of cellular immunotherapy.

On August 11, 2022 LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, reported financial results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, LianBio, AUG 11, 2022, View Source [SID1234618141]).

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"In the second quarter, LianBio achieved meaningful milestones that we believe serve as a testament to our strength in navigating the complex regulatory environments in Greater China and Asia," said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. "We continue to grow our organization, bringing on key new team members across clinical, medical affairs, quality and commercial functions. Despite clinical site and agency disruptions due to COVID-19 lockdowns in Shanghai and other cities in China, LianBio continued to execute our key clinical development and regulatory priorities, completing enrollment in the Phase 3 EXPLORER-CN trial of mavacamten and submitting marketing applications for both mavacamten and infigratinib in Asia Pacific territories. We believe the enthusiasm for mavacamten’s potential as a treatment for obstructive hypertrophic cardiomyopathy (oHCM) among both the clinical community and the world’s largest oHCM population is high, and we expect to report topline results from EXPLORER-CN in mid-2023. As we work to complete the EXPLORER-CN study over the coming months to support registration in China, we turn our focus to potential launch and preparations for LianBio’s next phase of evolution as a commercial-stage company. We remain on track to initiate three additional registration-enabling clinical programs in China this year, solidifying our position as a key partner in cross-border drug development. I am continually proud of our global team’s efforts to bring innovative medicines to patients in Asia."

Recent Business Highlights and Clinical Development Updates

Mavacamten progress continues in Asia with enrollment completed in China Phase 3 trial and New Drug Application submitted in Singapore

In May 2022, LianBio submitted an NDA to the Singapore Health Sciences Authority for mavacamten for the treatment of adults with symptomatic New York Heart Association Class II-III obstructive hypertrophic cardiomyopathy (oHCM). The submission was based on the U.S. Food and Drug Administration (FDA) approval of mavacamten.
In August 2022, enrollment was completed in the Phase 3 EXPLORER-CN clinical trial of mavacamten in Chinese patients with oHCM.
Infigratinib New Drug Application in 2nd line cholangiocarcinoma submitted in Hong Kong

In July 2022, LianBio submitted an NDA to the Department of Health, the Hong Kong Special Administrative Region, China, for infigratinib for the treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement. The submission was based on the FDA approval of infigratinib.
Development partner ReViral Ltd. acquired by Pfizer Inc.

In June 2022, Pfizer completed its acquisition of LianBio’s development partner ReViral and its respiratory syncytial virus therapeutic candidates, including sisunatovir. LianBio holds development and commercial rights to sisunatovir in mainland China, Hong Kong, Macau and Singapore.
LYR-210 clinical development program refined

LianBio plans to conduct a Phase 3 China standalone trial to support regulatory approval in China, leveraging the results of development partner Lyra’s ongoing Phase 3 trial, which is expected to complete enrollment in mid-2023.
Development partner Tarsus advances TP-03 into clinical trial in second indication

In August 2022, LianBio’s development partner Tarsus initiated a Phase 2a clinical trial of TP-03 in patients with meibomian gland disease (MGD).
Development partner Landos Biopharma reports data from NX-13 program

In August 2022, Landos announced topline results from a Phase 1b clinical trial of NX-13 demonstrating NX-13 was well tolerated. Based on these data, Landos plans to initiate a Phase 2 clinical trial to evaluate the safety, efficacy and optimal dosing of NX-13 in ulcerative colitis patients.
Business is well-positioned to achieve anticipated milestones

Current cash runway is projected to extend into the second half of 2024.
Key Milestones Anticipated in 2022 and 2023

Mavacamten

LianBio expects to report topline data from the Phase 3 EXPLORER-CN trial of mavacamten in Chinese patients with symptomatic oHCM in mid-2023.
TP-03

LianBio expects to initiate a Phase 3 study in Chinese patients with Demodex blepharitis in the second half of 2022. LianBio expects this study will support registration of TP-03 in China.
NBTXR3

LianBio expects to begin dosing patients in Nanobiotix’s global Phase 3 NANORAY-312 clinical trial of NBTXR3 for the treatment of locally advanced head and neck squamous cell carcinoma in elderly patients ineligible for cisplatin in the second half of 2022. LianBio expects this study will support registration of NBTXR3 in China and other LianBio-licensed territories in Asia.
Infigratinib

Enrollment is ongoing in LianBio’s Phase 2a clinical trial of infigratinib in locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification and other advanced solid tumors with FGFR genomic alterations.
LianBio expects to begin dosing Chinese patients in Helsinn’s ongoing global pivotal Phase 3 PROOF-301 clinical trial of infigratinib in first-line cholangiocarcinoma (CCA) patients with FGFR2 gene fusions/translocations in the second half of 2022.
BBP-398

LianBio expects to initiate a Phase 1 monotherapy clinical trial of BBP-398 in advanced solid tumors in the fourth quarter of 2022.
LianBio also expects to initiate a Phase 1 clinical trial of BBP-398 in combination with an EGFR-inhibitor in non-small cell lung cancer in the first half of 2023.
Second Quarter 2022 Financial Results

Research & Development Expenses
Research and development expenses were $28.6 million for the second quarter of 2022 compared to $93.0 million for the second quarter of 2021, and $40.9 million for the six month period ended June 30, 2022 compared to $146.4 million for the six month period ended June 30, 2021. The decrease was primarily attributable to increased milestone payments in 2021, and was offset by higher development activities to support clinical trials and personnel-related expenses in 2022.

General & Administrative Expenses
General and administrative expenses were $14.6 million for the second quarter of 2022 compared to $6.5 million for the second quarter of 2021, and $30.6 million for the six month period ended June 30, 2022 compared to $13.6 million for the six month period ended June 30, 2021. The increase was primarily attributable to increases in payroll and personnel-related expenses (including share-based compensation expense) for increased employee headcount and higher expense for legal, consulting and accounting services.

Net Loss
Net loss was $42.4 million for the second quarter of 2022 compared to net loss of $100.4 million for the second quarter of 2021, and $70.1 million for the six month period ended June 30, 2022 compared to $162.0 million for the six month period ended June 30, 2021.

Cash Balance
Cash, cash equivalents, marketable securities and restricted cash at June 30, 2022 totaled $349.4 million compared to $403.2 million as of December 31, 2021. LianBio projects its current cash, cash equivalents, marketable securities, and restricted cash will be sufficient to fund its current operating plan into the second half of 2024.