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.

On November 9, 2021 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported financial results for the third quarter and nine months ended September 30, 2021 and provided an update on recent developments (Press release, CorMedix, NOV 9, 2021, View Source [SID1234594991]).

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Recent Corporate and Regulatory Highlights:

As noted previously, there was a delay as a result of issues at the third-party manufacturer, or CMO, unrelated to the manufacture of DefenCath. Together with our CMO, we have been able to resume manufacturing activities and are continuing to complete the work that is required to address the deficiencies identified at the manufacturing facility.

CorMedix continues to work diligently toward the resubmission of the DefenCath NDA and plans to provide an update when we have clarity on the submission timeline.

CorMedix announced in October that its Board had appointed Matt David M.D., CorMedix’s EVP and Chief Financial Officer, as interim Chief Executive Officer. In addition, CorMedix expanded the responsibilities of Phoebe Mounts, Ph.D., Esq., EVP, General Counsel, and Head of Regulatory, Compliance, and Legal to include leadership of the Technical Operations group.

CorMedix presented three abstracts at industry conferences including the Association of Managed Care Pharmacy (AMCP) Nexus conference in October and the American Society of Nephrology (ASN) conference in November. The presentations highlighted retrospective analyses that were conducted to better understand the incidence of and mortality related to CRBSIs and economic costs related to these infections.

Cash and short-term investments, excluding restricted cash, at September 30, 2021 amounted to $72.0 million.
Dr. Matt David, CorMedix interim CEO, commented, "We are pleased that we have been able to resume manufacturing activities at our CMO and look forward to providing updates over the coming months. As the recent industry conference presentations have highlighted, catheter related bloodstream infections are common in patients receiving hemodialysis via central venous catheters and are associated with significant morbidity and mortality. We remain steadfast in our commitment to these patients as we seek to bring DefenCath to market upon its approval."

Third Quarter and Nine Month 2021 Financial Highlights

For the third quarter of 2021, CorMedix recorded a net loss of $8.6 million, or $0.22 per share, compared with a net loss of $6.6 million, or $0.22 per share, in the third quarter of 2020. The higher net loss recognized during the third quarter of 2021 compared with 2020 was due to the net increase in costs related to the manufacturing of DefenCath prior to its potential marketing approval.

Operating expenses in the third quarter of 2021 increased approximately 30% to $8.6 million, compared with $6.6 million in the third quarter of 2020. R&D expense increased approximately 62% to $4.7 million compared to $2.9 million in the third quarter of 2020, mainly due to net increase in costs related to the manufacturing of DefenCath prior to its potential marketing approval. SG&A expense increased approximately 4% to $3.8 million compared with $3.7 million in the third quarter of 2020. This increase was driven primarily by an increase in non-cash charges for stock-based compensation and an increase in personnel expenses, partially offset by decreases in costs related to market research studies in preparation for the potential marketing approval of DefenCath and in consulting fees.

For the nine months ended September 30, 2021, CorMedix recorded a net loss of $20.4 million, or $0.54 per share, compared with a net loss of $15.9 million, or $0.58 per share, in the first nine months of 2020. The increase in net loss in the first nine months of 2021 was driven primarily by a lower tax benefit from the New Jersey NOL program.

Operating expenses in the first nine months of 2021 were $21.7 million compared with $21.2 million during the comparable period in 2020, an increase of $0.5 million, or 2%. This increase was primarily due to higher SG&A expenses throughout the organization, partially offset by a net decrease in costs related to the manufacturing of DefenCath prior to its potential marketing approval.

Total cash on hand and short-term investments as of September 30, 2021 was $72.0 million, excluding restricted cash of $0.2 million. The Company believes that, based on the Company’s cash resources at September 30, 2021, it has sufficient resources to fund operations at least through 2022, after taking into consideration the costs for re-submission of the NDA and initial preparations for the commercial launch for DefenCath.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, November 9, 2021, at 4:30 PM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information is as follows:

On November 9, 2021 Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, reported third quarter 2021 financial results and provided an update on the cytisinicline clinical development program (Press release, OncoGenex Pharmaceuticals, NOV 9, 2021, View Source [SID1234594990]).

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Recent Highlights

Provided an update on the ORCA-2 Phase 3 clinical trial, including announcing that all subjects have completed the treatment portion of the study and are in follow-up, and that topline data is expected in the first half of 2022
Discussed ongoing planning activities for ORCA-3, the second Phase 3 clinical trial supporting cytisinicline regulatory submission in the United States, which Achieve anticipates could launch by early 2022
Announced FDA acceptance of IND application for the evaluation of cytisinicline in nicotine e-cigarette cessation
Issued two new patents from the United States Patent and Trademark Office covering the novel 3.0 mg TID cytisinicline dosing regimen
Presented cytisinicline data at the Society for Research on Nicotine & Tobacco Europe (SRNT-E) annual meeting
Announced expansion of cytisinicline clinical operations team
"It has been another successful quarter as we continue to focus on meeting our key development milestones, specifically, completing the Phase 3 ORCA-2 trial, and preparing for the initiation of two new cytisinicline trials," commented John Bencich, Chief Executive Office of Achieve. "We are looking forward to an exciting year ahead with the expected ORCA-2 Phase 3 data results, the start of our second Phase 3 study in cigarette smoking cessation and launch of the grant-funded ORCA-V1 trial in e-cigarette cessation."

Ongoing ORCA-2 Phase 3 Clinical Trial
Achieve provided an update on the cytisinicline development program in adult cigarette smokers in the United States. The ORCA-2 Phase 3 trial completed enrollment of 810 subjects. To date, all subjects have completed study treatment and are currently in follow-up. The last subject is expected to complete their final visit by the end of 2021, with topline data expected to be announced in the first half of 2022.

Planned ORCA-3 Phase 3 Clinical Trial
Achieve reviewed ORCA-3 planning activities and announced that it has completed selection of a Contract Research Organization (CRO), finalized cytisinicline packaging and drug supply, and is currently undergoing clinical trial site selection. The trial is expected to initiate enrollment of approximately 750 adult cigarette smokers by early 2022.

FDA Acceptance of IND for Study of Cytisinicline in e-Cigarette Cessation
Achieve announced that the U.S. Food and Drug Administration (FDA) has completed their review and accepted an Investigational New Drug (IND) application to investigate cytisinicline as a cessation treatment for nicotine e-cigarette users. The Phase 2 ORCA-V1 study will enroll approximately 150 adult nicotine e-cigarette users in the United States and is expected to initiate in the second quarter of 2022. Grant funding to support the trial has been awarded in two phases from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH). Completion of required milestones for the first phase of grant funding included the submission of the IND and clearance to proceed with the clinical trial by FDA.

Patents Issued for 3.0 mg TID Dosing Regimen
The U.S. Patent and Trademark Office issued U.S. Patent No. 11,083,715 and U.S. Patent No. 11,083,716 covering the novel 3.0 mg TID cytisinicline dosing regimen. Not including any patent term extensions to which Achieve may be entitled, the newly issued patents will expire in the third quarter of 2040. Upon approval of cytisinicline by the FDA, Achieve anticipates these patents would be included in the FDA’s Orange Book, which lists approved drugs and related patent and exclusivity information.

Cytisinicline Data Presented at SRNT-E Annual Meeting
Two cytisinicline data presentations were included in the SRNT-E annual meeting, held in September 2021. An analysis from the ORCA-1 trial found that subjects who previously failed to quit smoking with Chantix (varenicline) experienced a Week 4 abstinence rate of 51.3% upon treatment with cytisinicline using the three times daily (TID) regimen, compared with 15.8% with placebo (p= 0.009). An additional analysis, also from the ORCA-1 trial, found that smokers treated in the study with cytisinicline showed an earlier onset of sustained abstinence compared with placebo. Smokers who received the cytisinicline 3 mg TID had the shortest time to sustained smoking abstinence with a median of only 7 days of treatment compared to 18 days for placebo.

Expanded Clinical Operations Team
Achieve announced the expansion of its clinical operations team to include a Senior Director of Biometrics, Senior Manager of Clinical Trials, and Director of Clinical Operations, to support efforts with the ongoing and planned cytisinicline development program.

Financial Results
As of September 30, 2021, Achieve’s cash equivalents, and restricted cash was $33.4 million. Total operating expenses for the three and nine months ended September 30, 2021 were $6.7 million and $26.0 million, respectively. Total net loss for the three and nine months ended September 30, 2021 was $6.7 million and $26.0 million, respectively.

As of November 9, 2021, Achieve had 9,453,542 shares outstanding.

Conference Call Details
Achieve will host a conference call at 4:30pm Eastern time today, Tuesday, November 9, 2021. To access the webcast, log on to the investor relations page of the Achieve website at View Source Alternatively, access to the live conference call is available by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 7997636. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.