On November 9, 2021 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, reported updated results from ASPEN-01, an ongoing evorpacept phase 1b study, evaluating patients with solid tumor malignancies at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s ("SITC") 36th Anniversary Annual Meeting [abstract 498] (Press release, ALX Oncology, NOV 9, 2021, View Source [SID1234594998]).

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ALX Oncology reports updated results from both cohorts: the gastric/gastroesophageal junction cancer ("GC") patient cohort receiving evorpacept plus trastuzumab plus chemotherapy, and from the head and neck squamous cell carcinoma ("HNSCC") patient cohort receiving evorpacept plus pembrolizumab with and without chemotherapy. All data reflect response evaluable patients as of September 1, 2021. The SITC (Free SITC Whitepaper) 36th Anniversary Annual Meeting poster is available to download under "Publications" in the Science section of the ALX Oncology website at www.alxoncology.com.

In patients with >2L HER2 positive GC (n=18), evorpacept in combination with trastuzumab plus ramucirumab and paclitaxel demonstrated an initial objective response rate ("ORR") of 72.2% with a median duration of response ("mDOR") of 14.8 months, a 12-month overall survival ("OS") rate of 79%, and a median overall survival ("mOS") of 17.1 months. These results compare favorably with the clinical experience of both ramucirumab + paclitaxel and trastuzumab-deruxtecan in similar populations.

In patients with 1L HNSCC who have not received prior treatment for their advanced disease (n=13), evorpacept demonstrates an initial ORR of 38.5% with a 12-month OS rate of 87.5% and mOS not reached in combination with pembrolizumab + 5FU + platinum. These results compare favorably with benchmark survival data from standard pembrolizumab + chemotherapy in the 1L HNSCC setting where ORR is a less reliable predictor for clinical benefit compared to longer-term metrics such as 12-month OS rate and mOS (the gold standard of clinical benefit) in patients with aggressive disease.
In patients with ≥2L HNSCC who have not received a prior checkpoint inhibitor ("CPI") (n=10), long-term follow-up data shows that evorpacept + pembrolizumab demonstrates a 12-month OS rate of 80% with a mOS of 24.5 months, which compares favorably with standard pembrolizumab therapy in patients with 2L CPI naïve HNSCC.

Preliminary data suggest that evorpacept is well tolerated when combined with the multi-agent chemotherapy regimens studied with no maximum tolerated dose reached.
"These updated data provide growing support that evorpacept in combination with the standard regimens studied may translate into a meaningful survival benefit in patients with advanced HNSCC and GC who historically have poor outcomes," said Keun-Wook Lee, M.D., Ph.D., Professor of Seoul National University College of Medicine and Director of Clinical Trials Center, Seoul National University Bundang Hospital, Seoul, Korea.

"The consistency and predictive value of evorpacept’s emerging survival-based data in aggressive solid tumor diseases is highly encouraging," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "We are excited to investigate the impact of evorpacept on these longer-term measures of clinical benefit in our randomized phase 2 programs in patients with HNSCC (ASPEN-03 and ASPEN-04) and GC (ASPEN-06)."

Conference Call on November 9th at 8:00 a.m. EST
ALX Oncology will host a conference call on Tuesday, November 9, 2021 at 8:00 a.m. EST to further discuss the recent GC and HNSCC data from ASPEN-01, the Phase 1b study of evorpacept that was presented at the SITC (Free SITC Whitepaper) 36th Anniversary Annual Meeting. In addition to ALX Oncology’s executive management team, Dr. Kevin Harrington, Professor of Biological Cancer Therapies and Head of the Division of Radiotherapy and Imaging at the Institute of Cancer Research, London, UK will be featured on the call to discuss the latest evorpacept clinical data in HNSCC patients.

To access the conference call, please dial (844) 467-7655 (U.S./Canada) or (409) 983-9840 (international) at least 10 minutes prior to the start time and refer to conference ID 1291278. Presentation slides will be available to download under "News & Events" (see "Events") in the Investors section of the ALX Oncology website at www.alxoncology.com.

On November 9, 2021 Cardinal Health (NYSE: CAH) reported first quarter fiscal year 2022 revenues of $44.0 billion, an increase of 13% from the first quarter of last year (Press release, Cardinal Health, NOV 9, 2021, View Source [SID1234594997]). First quarter GAAP operating earnings were $415 million and GAAP diluted earnings per share (EPS) were $0.94. Prior year first quarter GAAP results included an operating loss of $624 million due to a $1.0 billion pretax accrual related to opioid litigation. Non-GAAP operating earnings decreased 15% to $527 million in the quarter, primarily due to a decline in Medical segment profit. Non-GAAP diluted earnings per share decreased 15% to $1.29.

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"Our first quarter results were in line with our expectations," said Mike Kaufmann, CEO of Cardinal Health. "We are reaffirming our full-year non-GAAP EPS guidance, despite our expectation that we will see greater inflationary pressures in the Medical segment for the remainder of the year, which we are taking action to mitigate. With an additional $3 billion share repurchase authorization and our commitment to our dividend, we are positioned to return capital to shareholders, while prioritizing investment in our growth businesses, technology and digital transformation, simplifying our operating model, and strengthening our core businesses," Kaufmann concluded.

First-quarter revenue for the Pharmaceutical segment increased 13% to $39.8 billion, driven primarily by branded pharmaceutical sales growth from large Pharmaceutical Distribution and Specialty customers.

Pharmaceutical segment profit increased 1% to $406 million in the first quarter. This reflects an improvement in volumes compared to the prior year, which was adversely impacted by COVID-19. This improvement was largely offset by investments in technology enhancements.

First-quarter revenue for the Medical segment increased 5% to $4.1 billion, driven primarily by PPE sales. This was partially offset by the divestiture of the Cordis business.

Medical segment profit decreased 46% to $123 million in the first quarter primarily due to elevated supply chain costs. To a lesser extent, this also reflects the divestiture of the Cordis business as well as net favorability in the prior year attributed to COVID-19.

Fiscal year 2022 outlook1
The company reaffirmed its fiscal year 2022 guidance range for non-GAAP diluted earnings per share attributable to Cardinal Health, Inc. of $5.60 to $5.90.

This guidance includes an update to Medical segment profit outlook to mid-single to low-double digit percentage decline, from low-double digit percentage growth. This update reflects net incremental elevated supply chain costs of approximately $100 million to $125 million. Additionally, the company updated expectations for its fiscal 2022 non-GAAP effective tax rate to 23% to 25%, from 23.5% to 25.5%, and its diluted weighted average shares outstanding to 280 million to 282 million, from 287 million to 292 million.

The company does not provide forward-looking guidance on a GAAP basis as certain financial information, the probable significance of which cannot be determined, is not available and cannot be reasonably estimated. See "Use of Non-GAAP Measures" following the attached schedules for additional explanation.

Long-term financial targets
The company announced long-term segment profit targets of low to mid-single digit growth in the Pharmaceutical segment and mid to high-single digit growth in the Medical segment. The company is also targeting to average a double-digit combined Non-GAAP EPS growth and dividend yield.

Recent highlights

Cardinal Health Board of Directors approved a 3-year authorization to repurchase up to an additional $3 billion of Cardinal Health common shares, which will expire on December 31, 2024.
Cardinal Health, along with pharmaceutical distribution peers, announced that enough states have agreed to participate in the previously announced proposed settlement agreement to proceed to the next phase, which is the subdivision sign-on period.
Cardinal Health announced a comprehensive talent strategy to increase representation of diverse employees at the manager level and above by 2030 and established a goal to reduce Scope 1 and Scope 2 greenhouse gas emissions 50% by 2030.
Cardinal Health announced that it has extended its agreements with CVS Health to distribute pharmaceuticals to retail pharmacies and distribution centers through June 30, 2027.
Cardinal Health announced an agreement with TerraPower that will help develop and produce Actinium-225, which will be utilized in drug trials involving targeted alpha therapy for diseases such as breast, prostate, colon and neuroendocrine cancers, melanoma and lymphoma.
Cardinal Health announced its efforts to commercialize and broaden access to over-the-counter rapid COVID-19 tests through partnerships with Abbott and Quidel Corporation.
Upcoming webcasted investor events

Credit Suisse 30th Annual Healthcare Conference at 10:30 a.m. EST, November 10, 2021
J.P. Morgan 40th Annual Healthcare Conference on January 10-13, 2022
Webcast
Cardinal Health will host a webcast today at 8:30 a.m. EST to discuss first quarter 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 November 8, 2022.

On November 9, 2021 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that management will present and participate virtually at the 12th Annual Jefferies London Healthcare Conference (Press release, Oncternal Therapeutics, NOV 9, 2021, View Source [SID1234594994]).

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Time and date: Virtual presentation available on-demand beginning on Thursday, November 18 at 8:00 a.m. GMT / 3:00 a.m. ET through Friday, November 19 at 5:00 p.m. GMT / 12:00 p.m. ET
Presenter: James Breitmeyer, M.D., Ph.D., President and CEO
Webcast Link: View Source
Links to the webcast and replay will be accessible on the Events & Presentations page of the Investors section on the Company’s website at investor.oncternal.com.

On November 9, 2021 Signify Health, Inc. (NYSE: SGFY), a leading healthcare platform that leverages advanced analytics, technology and nationwide healthcare networks to create and power value-based payment programs, reported the Company’s financial results for the third quarter of 2021 and nine months ended September 30, 2021 (Press release, Signify Health, NOV 9, 2021, View Source [SID1234594993]).

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"Year-to-date through the end of September, our broad network of highly qualified doctors and nurse practitioners performed over 1.4 million comprehensive in-home evaluations that aid care gap closures, address social determinants of health, and assess behavioral needs," said Kyle Armbrester, Chief Executive Officer of Signify Health. "Our team of clinicians, working together with our social and engagement coordinators, compassionately interacts with a growing number of individuals across the entire country to connect and drive engagement with the broader healthcare system to have more healthy, happy days at home. While doing this important work, we achieved strong financial performance in the third quarter and for the nine-months ended September 30, 2021, as increasing customer demand for our in-home evaluations drove strong Home & Community Services results in the third quarter and is expected to create strong momentum going into 2022."

Mr. Armbrester continued, "In our Episodes of Care Services segment, we continue to deliver strong savings to our customers and ensure superior care to individuals during their healthcare episodes. We are on track to deliver a 2021 program size exit run rate of approximately $6 billion in our episodes business, setting up strong BPCI-A program size for 2022. Additionally, we continue to expand our Networks of Distinction for the future growth of our non-BPCI-A episodes of care business."

Third Quarter 2021 Financial Results

Total revenue for the third quarter of 2021 increased 29% to $ 199.2 million, up from $154.7 million in the same period a year ago. Overall growth in the third quarter of 2021 was driven by strength in Home & Community Services (HCS).
HCS revenue grew to $169.1 million in the third quarter of 2021, an increase of 47% over the same period a year ago, due to in-home evaluation (IHE) volume of approximately 488 thousand in the quarter compared to approximately 362 thousand in the third quarter of 2020.
Third quarter 2021 revenue was $30.1 million for the Episodes of Care Services (ECS) segment compared to $40.0 million in the same period a year ago. The decline was primarily due to the adverse impact of COVID-19 on program size and the savings rate. Additionally, there was approximately $9.2 million of revenue recorded during the three months ended September 30, 2020 reflecting positive changes in estimates based on new information received ahead of the reconciliation due in the fourth quarter 2020. The new information included the impact of COVID-19 on program size and the subsequent options CMS offered to providers that had an overall beneficial impact on savings rates.
Third quarter 2021 total net income was $29.3 million, compared to a net loss of $13.3 million for the same period a year ago, due to the improvement in operating performance as well as the quarterly revaluation of customer Equity Appreciation Rights agreements, or EARs. The EARs are marked to market each quarter and this resulted in a credit of $27.3 million reflecting the current lower value of the stock.
Non-GAAP Adjusted EBITDA1 for the third quarter of 2021 increased 46% to $42.0 million, compared to $28.7 million for the third quarter of 2020, driven primarily by HCS growth, partially offset by higher operating expenses related to investments made to support our growth and technology. Non-GAAP Adjusted EBITDA margin1 for the third quarter of 2021 was 21.1%, a 250-basis point improvement from the third quarter of 2020.
Nine Months Ended September 30, 2021 Financial Results

Total revenue for the nine months ended September 30, 2021 increased 42% to $592.0 million, up from $417.1 million in the same period a year ago. Overall growth for the nine-month period ended September 30, 2021 was driven by momentum in HCS.
HCS revenue for the nine months ended September 30, 2021 was $496.9 million, a 65% increase from the nine-months ended 2020, due to an increase in IHE volume to approximately 1.447 million compared to approximately 963 thousand in the same period of 2020 and the lower relative volume of virtual IHEs in 2021 when compared to 2020. Virtual IHEs have a lower cost per evaluation than in-person IHEs.
ECS revenue for the nine months ended September 30, 2021 decreased 17% compared to the prior year period to $95.1 million, reflecting lower program size and savings rates due to the impact of COVID-19.
Net loss for the nine months ended September 30, 2021 was $22.5 million, compared to a net loss of $15.2 million in the comparable period a year ago.
Non-GAAP Adjusted EBITDA1 for the nine months ended September 30, 2021 increased 52% to $131.0 million, compared to $86.0 million for the same period in 2020, driven primarily by HCS growth. Non-GAAP Adjusted EBITDA margin1 for the nine months ended September 30, 2021 was 22.1%, a 150-basis point improvement from the same period a year ago.
2021 Outlook

Signify Health is raising its total revenue and adjusted EBITDA guidance ranges for 2021 as follows:

Total GAAP revenue in the range of $755 million to $770 million; and
Total adjusted EBITDA1 in the range of $160 million to $170 million.

We are providing estimates for key performance indicators for the full year 2021, as follows:

Reflecting continued strength in Home and Community Services, we now expect IHEs in the range of approximately 1.815 to 1.855 million
For Episodes of Care Services, we are maintaining our estimates of:
ECS segment weighted average program size of approximately $4.9 to $5.1 billion dollars; and
ECS segment weighted average savings rate of approximately 6.1% to 6.4%
1Adjusted EBITDA and Adjusted EBITDA margin are non-GAAP financial measures. Refer to the reconciliation in "Non-GAAP Financial Measures." We have not reconciled 2021 guidance for adjusted EBITDA to net income (loss), the most directly comparable GAAP measure, and have not provided forward-looking guidance for net income (loss) because of the uncertainty around certain items that may impact net income (loss), including, among others, stock-based compensation and the fair valuation of the EARs, that are not within our control or cannot be reasonably estimated.

Conference Call Information

Signify Health will host a conference call to discuss the Company’s third quarter 2021 results on November 10, 2021 at 8:30am ET. A live audio webcast of the conference call may be accessed through the investor relations section of Signify Health’s website at investors.signifyhealth.com/events/default.aspx and will be available for replay through January 10, 2022.

On November 9, 2021 Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, reported recent business progress and third-quarter financial results (Press release, Kronos Bio, NOV 9, 2021, View Source [SID1234594992]).

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"As we approach the end of the year, we look forward to reporting interim data from the ongoing Phase 1/2 study of our internally discovered CDK9 inhibitor, KB-0742, capping off a year of significant progress," said Norbert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. "In addition to continued execution across our clinical stage programs, I am also pleased with the progress we are making with our pipeline – particularly the addition of two new discovery programs, which underscore the capabilities of our product engine."

Pipeline Progress
Kronos Bio reported it has initiated two new discovery programs, each focused on a distinct target or node identified through the company’s research and mapping of the MYC and AR transcriptional regulatory networks (TRNs).

Target 1: MYC TRN. Dysregulation of the MYC TRN is a hallmark of cancer and occurs in a large percentage of cancers. The company’s existing development candidate, KB-0742, targets CDK9 and is being evaluated in a Phase 1/2 clinical study. KB-0742 is intended to target MYC dysregulation in the context of MYC genomic amplification, which occurs in 30% of all solid tumors. The new Target 1 program is aimed at modulating a protein-protein interaction in the MYC TRN with the objective of treating additional MYC-dysregulated cancers beyond those targeted by KB-0742.
Target 2: AR TRN. Dysregulation of the AR (androgen receptor) TRN is a primary driver of prostate cancer. Although therapies that directly inhibit the androgen receptor already exist, many patients with prostate cancer ultimately develop resistance to these therapies and patients with castration-resistant prostate cancer (CRPC) have a particularly poor prognosis. This new program aims to overcome resistance to current therapies by targeting an AR cofactor that selectively modulates the AR TRN in the context of CRPC.
The company anticipates identifying a lead candidate and submitting an Investigational New Drug (IND) application out of one of its discovery programs in 2023.
Additionally, Kronos Bio yesterday announced a multi-year collaboration with Tempus, a leader in artificial intelligence and precision medicine. The agreement will provide Kronos Bio with access to real-world patient genomic and transcriptomic data and data analytics tools, with the goal of accelerating the development of the company’s current and future clinical portfolio.

Third-Quarter Company Highlights

Kronos Bio presented preclinical data characterizing the pharmacokinetic (PK) and pharmacodynamic (PD) profile of KB-0742 in a poster at the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in October 2021. These data build on results first shared at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting earlier this year. The new data demonstrated a favorable preclinical PK profile and human PK projection that support the intermittent dosing schedule for patients in the Phase 1/2 study.
The U.S. Food and Drug Administration cleared the company’s IND for lanraplenib, a next-generation spleen tyrosine kinase (SYK) inhibitor. This allows Kronos Bio to proceed with its planned Phase 1b/2 clinical trial of the compound in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia (AML) in combination with gilteritinib.
Upcoming Milestones

The company plans to report interim safety, PK and PD data in Q4 2021 from the ongoing dose escalation phase of its Phase 1/2 clinical trial of KB-0742, which is being developed to treat MYC-amplified or over-expressing solid tumors.
Kronos Bio remains on track to dose the first patient in its planned Phase 3 clinical trial of entospletinib before the end of the year, with a data readout expected in the second half of 2023. This trial will assess measurable residual disease (MRD) negative complete response as the primary endpoint to support potential accelerated approval in patients newly diagnosed with NPM1-mutated AML and eligible for intensive induction chemotherapy.
The company expects to dose the first patient in the first of two planned Phase 1b/2 clinical trials of lanraplenib in the first quarter of 2022. This first trial will evaluate lanraplenib in patients with relapsed or refractory FLT3-mutated AML.
Kronos Bio plans to initiate a second Phase 1b/2 clinical trial of lanraplenib, in combination with venetoclax/azacitidine in patients newly diagnosed with NPM1-mutated and/or FLT3-mutated AML who are older than age 75 or not eligible for intensive induction chemotherapy in the first half of 2022.
Third Quarter Financial Highlights

Cash, Cash Equivalents and Investments: As of September 30, 2021, cash, cash equivalents and investments totaled $398.4 million.

R&D Expenses: Research and development expenses were $24.7 million for the third quarter of 2021, which includes non-cash stock-based compensation expense of $3.5 million.

G&A Expenses: General and administrative expenses were $9.0 million for the third quarter of 2021, which includes non-cash stock-based compensation expense of $3.6 million.

Net Loss: Net loss for the third quarter of 2021 was $33.6 million, or $0.61 per share, including non-cash stock-based compensation expense of $7.1 million.