On November 8, 2022 Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, reported the prioritization of its clinical portfolio to focus on the development of its next generation SYK inhibitor, lanraplenib, and its CDK9 inhibitor, KB-0742 (Press release, Kronos Bio, NOV 8, 2022, View Source [SID1234623566]).

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The company is discontinuing the Phase 3 trial of its SYK inhibitor, entospletinib, for the treatment of newly diagnosed patients with NPM1-mutated acute myeloid leukemia (AML) and plans to close the trial to further enrollment. Patients already enrolled in the trial may complete their course of treatment. The trial is not being discontinued due to adverse events or lack of efficacy signals.

Kronos Bio decided to end the trial after its recent review of enrollment data. In this assessment, the company projected significant delays due to several factors, including the operational challenges the company faced in enrolling a genetically defined subset of patients in a front-line setting, the residual and ongoing impacts of the COVID-19 pandemic, and the inability to activate planned clinical trial sites in Russia and Ukraine.

Kronos Bio believes the most promising path forward for bringing a transformational therapy to patients for the treatment of AML is to focus the company’s SYK inhibitor program on lanraplenib, initially in the relapsed/refractory setting where the need is particularly acute. The company will also continue to prioritize its investigational CDK9 inhibitor, KB-0742, which is currently in a Phase 1/2 clinical trial in patients with solid tumors, with a planned update on the trial on track for the fourth quarter.

This prioritization is expected to extend cash runway from the fourth quarter of 2024 into the second quarter of 2025.

"Focusing on lanraplenib and KB-0742 will allow us to direct our resources to the highest value programs and deliver on our mission of bringing cancer drugs to the patients with the greatest need," said Norbert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. "This is the right decision at the right time, and it makes us a stronger company as a result. I want to express my gratitude to the clinicians and the patients who participated in our entospletinib trial, as well as our employees, for their contributions to advancing potential new therapies to treat AML."

The company will also continue to invest in its platform-based discovery and development programs, as it works toward an investigational new drug application for its next pipeline candidate.

Lanraplenib Phase 1b/2 Trial: A Next-Generation SYK Inhibitor with Potential to Address Significant Unmet Need Among Patients with R/R AML

Kronos Bio remains committed to its SYK inhibitor program and to patients with AML. The company is advancing the lanraplenib program based on the strong biological rationale for the targeting of SYK in patients with genetically defined subsets of AML. This includes NPM1 and FLT3 mutations, as well as MLL rearrangement.

Lanraplenib has a number of advantages over entospletinib, including once daily dosing and the ability to be taken fed or fasted. Additionally, lanraplenib may be co-administered with proton-pump inhibitors for patients who require these medications to manage their gastro-esophageal reflux or related conditions. Lanraplenib has demonstrated favorable pharmacokinetic (PK), pharmacodynamic (PD) and safety in more than 250 trial participants, including healthy volunteers and patients with autoimmune diseases. In preclinical studies, lanraplenib was shown to have anti-leukemic activity against NPM1-mutated and FLT3-mutated patient-derived AML cells and to synergize with gilteritinib.

Kronos Bio is actively enrolling patients in the dose escalation portion of a Phase 1b/2 trial. The trial is aimed at a group of patients with low response rates to gilteritinib, the only therapy currently approved for this patient population, and generally poor prognosis. Only an estimated 10% of patients with relapsed/refractory AML survive five years from the time of relapse.

"Outcomes are poor for patients with relapsed/refractory AML and there is significant need for better treatment options," said Jorge DiMartino, M.D., Ph.D., chief medical officer and executive vice president of Clinical Development of Kronos Bio. "Beyond this first indication, lanraplenib has the potential to be a cornerstone of future targeted treatment regimens in AML and today’s announcement positions us to focus our resources where the need is the greatest with the greatest possible urgency."

Lanraplenib has the potential for use in combination with a number of additional targeted agents in genetically defined subsets of AML. This includes both additional relapsed/refractory disease indications, as well as in patients with newly diagnosed AML.

The company anticipates sharing initial data from the lanraplenib/gilteritinib trial, along with the recommended Phase 2 dose (RP2D), in the fourth quarter of 2023 or first quarter of 2024.

Phase 1/2 KB-0742 Trial: Potential to Change Treatment Landscape Across Cancers

Kronos Bio remains on track to report PK, PD and safety data, as well as the recommended Phase 2 dose, from the Phase 1/2 trial of KB-0742 in the fourth quarter.

KB-0742 is a highly selective, orally bioavailable inhibitor of cyclin dependent kinase 9 (CDK9). CDK9 is a global regulator of transcription and key cofactor of many oncogenic transcription factors, including the MYC family of transcription factors. MYC is a long-recognized driver of cancer and sought-after drug target. MYC is amplified in approximately 30% of solid tumors, including those affecting the lungs, ovaries and breast.

"We remain enthusiastic about the potential of KB-0742 and will provide an update on the program during the fourth quarter," said Dr. Bischofberger. "We have seen strong preclinical evidence that demonstrates activity of KB-0742 across a number of tumor types. We look forward to sharing more about this compound before the end of the year."

After reaching RP2D, the company plans to enroll two cohorts of patients in the next stage of the trial: patients with MYC-amplified solid tumors and patients with transcriptionally addicted tumors.

Following the Q4 2022 update from ongoing KB-0742 trial, the company anticipates sharing initial KB-0742 efficacy data in the second half of 2023.

Conference Call

At 4:30 p.m. Eastern Time today, Kronos Bio will host a conference call to discuss this announcement. A live webcast will be available at View Source and will be archived on the website following the live event.

On November 9, 2022 Portage Biotech Inc., (NASDAQ: PRTG) ("Portage" or the "Company"), a clinical-stage immuno-oncology company developing therapies to improve patient lives and increase survival by avoiding and overcoming cancer treatment resistance, reported that it has entered into an agreement with Merck (known as MSD outside the US and Canada) (Press release, Portage Biotech, NOV 9, 2022, View Source [SID1234623544]). The collaboration will evaluate Portage’s lead invariant natural killer T cell (iNKT) agonist, PORT-2, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, for patients with front-line as well as PD-1 refractory non-small cell lung cancer (NSCLC).

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Under the terms of the agreement, Merck will be providing KEYTRUDA for Portage Biotech’s IMPORT-201 trial, a Phase 1/2 study of PORT-2 for patients with NSCLC and advanced melanoma (also known as KEYNOTE E69). The two companies will establish a Joint Development Committee to optimally evaluate the study’s combination arms.

PORT-2 is an iNKT agonist packaged in a liposome and is designed to activate both the innate and adaptive immune systems and inhibit negative signals in the tumor microenvironment. Preclinical data have shown that PORT-2 increases expression of PD-L1 on cancer cells. Additionally, PORT-2 demonstrated single agent activity in PD-1 resistant animal tumor models, and the combination of PORT-2 plus an anti-PD-1 antibody restored sensitivity to anti-PD-1 therapy in these models. As reported at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference, early clinical data suggests that PORT-2 is well tolerated and active as a monotherapy.

"We are pleased to collaborate with Merck, a long-established leader in cancer immunotherapy, to explore how our complementary mechanism with KEYTRUDA has the potential to further enhance long-term clinical benefit for people with cancer and also expand the eligible population to include those who do not currently receive anti-PD-1 therapy," said Dr. Ian Walters, Chief Executive Officer of Portage Biotech. "Checkpoint inhibitors have made a paradigm-shifting contribution to the cancer treatment landscape, but many patients still have a limited response or eventual recurrence. We see potential for our unique approach of using iNKT agonists to initiate an immune response in tumors that have become refractory to checkpoint therapy or to increase the number of front-line patients achieving more durable responses, and are excited to be collaborating with Merck to advance our clinical development for PORT-2."

Portage’s unique four arm Phase 2 trial, IMPORT-201, will seek to evaluate PORT-2 in multiple settings with unmet medical need:

Randomized cohort: Patients with first-line PD-L1 positive NSCLC (TPS PD-L1 >50%) will be randomized to receive KEYTRUDA alone or in combination with PORT-2. Those patients in the KEYTRUDA group will be offered the opportunity to cross over at progression to determine whether PORT-2 will resensitize them to checkpoint inhibition.
NSCLC proof of concept: Patients with PD-L1 negative (TPS <1%) NSCLC will undergo biopsy before and after one dose of PORT-2 to evaluate if PORT-2 increases PD-L1 expression, followed by treatment with PORT-2 in combination with KEYTRUDA.
Melanoma proof of concept: Patients with immunotherapy-refractory melanoma will be treated with PORT-2 monotherapy.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. LLC., Rahway, N.J., USA.

On November 8, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported the financial results and corporate updates for the first nine months 2022 (Press release, Evotec, NOV 8, 2022, View Source [SID1234623522]).

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HIGHLIGHTS
EVOTEC’S TOPLINE SUCCESS REFLECTS STRONG OVERALL DEMAND
Group revenues increased by 19% (13% excluding fx-effects) to € 510.8 m (9M 2021: € 431.0 m), despite significantly lower milestones, upfronts and license payments compared to a very strong comparable basis in 2021 (9M 2022: € 8.1 m vs. € 36.5 m in 9M 2021); base business at € 502.7 m continued to show very strong growth of 27% (9M 2021: € 394.5 m).
Strong progress in both segments: Total EVT Execute revenues (incl. intersegment revenues) up 23% to € 526.7 m (9M 2021: € 429.8 m); EVT Innovate revenues up 20% to € 121.9 m (9M 2021: € 101.9 m), against a very high comparable basis.
Other non-operating result of € (119.6) m (9M 2021: € 228.8 m), mainly driven by the non-cash fair value adjustments of the equity investment in publicly listed Exscientia plc.
Adjusted Group EBITDA totalled € 44.6 m (9M 2021: € 70.1 m); influenced by high expenses for capacity expansion to support the overall growth of Evotec, significantly inflated energy costs as well as lower contribution from milestones, upfronts and licenses, partially offset by positive fx-effects (€ 12.4 m); Just – Evotec Biologics is in its planned ramp up phase; Adjusted EBITDA excluding Just – Evotec Biologics at € 84.6 m (9M 2021: € 74.0 m).

SHARED R&D PLATFORMS FOR HIGHER PROBABILITIES OF SUCCESS (POS)
Multiple new and extended integrated drug discovery and development agreements all along the drug discovery & development value chain (e.g., integrated drug discovery agreement with Viotika, commercial manufacturing with Zogenix, ADME Tox agreements with UCB …)
Successful achievement of four performance-based milestones within existing partnerships; one IND submission, one preclinical development candidate nomination and one lead optimisation start
Significant progress within neuroscience collaboration with Bristol Myers Squibb ("BMS")
Expansion of E.MPD molecular patient database into autoimmune diseases through partnership with Hannover Medical School ("MHH") (after period-end)
Paradigm shift in biologics with Just – Evotec Biologics: Foundation laid for accelerated revenue growth through multiple new development and manufacturing agreements, e.g., with Alpine Immune Sciences; ground-breaking for second new biologics facility J.POD Toulouse, France, on 16 September
J.POD Redmond, Washington (US) joined the U.S. Department of Defense’s ("DOD") Advanced Development and Manufacturing network of facilities and wins a first contract worth up to $ 49.9 m; second award with the U.S. Department of Defense ("DOD") granted after period end.
Commercial launch of proprietary next-generation multi-omics data analysis platform PanHunter (after period-end).
Expansion of BRIDGE LAB150 to include Amgen as a strategic partner (after period-end)

CORPORATE
Expansion of clinical and commercial drug substance manufacturing capacities through acquisition of Central Glass Germany, operating as Evotec Drug Substance (Germany) GmbH ("Evotec DS").

BUSINESS OUTLOOK FOR FULL-YEAR 2022 UNCHANGED AND MID-TERM TARGETS 2025 CONFIRMED
Group revenues expected to be in a range of € 715 – 735 m or € 690 – 710 m at constant exchange rates (2021: € 618 m).
Adjusted Group EBITDA expected to be unchanged in the range of € 105 – 120 m, translating into € 85 – 100 m at constant exchange rates (2021: € 107 m).
Unpartnered research and development expenses expected to be in a range of € 70 – 80 m (2021: € 58 m).
Mid-term goals target revenue growth to > € 1,000 m, adjusted EBITDA of ≥ € 300 m and unpartnered research and development expenses of > € 100 m.

The forecast takes in account – as far as possible – the current increased global uncertainties related to e.g., the COVID-19 pandemic and the war in Ukraine, resulting in uncertainty around the global price and supply situation for energy, other raw materials and supplies as well as logistics relevant to the business. M&A related costs have not been part of the initial guidance and will therefore be excluded.

More detailed information and financial tables are available in our nine-month report published on the Evotec website under the following link: View Source

WEBCAST / CONFERENCE CALL
The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. The conference call will be held in English.

You will then receive a confirmation email with dedicated dial-in details such as telephone number, access code and PIN to access the call.

A simultaneous slide presentation for participants dialling in via phone is available at View Source

Webcast details

To join the audio webcast and to access the presentation slides you will find a link on our homepage shortly before the event.

The on-demand version of the webcast will be available on our website: View Source.

On November 8, 2022 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the third quarter ended September 30, 2022, and recent corporate highlights (Press release, Checkpoint Therapeutics, NOV 8, 2022, View Source [SID1234623521]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "In the third quarter of 2022, we successfully completed two pre-Biologics License Application ("BLA") meetings with the U.S. Food and Drug Administration ("FDA"). Importantly, we continue to achieve significant progress toward our planned submission of a BLA by January of next year, which will include both the metastatic and locally advanced cutaneous squamous cell carcinoma ("cSCC") indications. We believe cosibelimab, with its differentiated two-fold mechanism of action, has the potential to be the first anti-PD-L1 antibody approved for advanced cSCC, which is the second most frequently diagnosed skin cancer, and provide physicians worldwide with an important new treatment option in the fight against this common and possibly deadly cancer. Our planned BLA submission will represent a significant milestone both for us as a company and for patients seeking treatment for cSCC."

"The reverse stock split recently approved by shareholders and planned for December is a proactive measure that we are confident will improve long-term liquidity and better position us for success by providing the opportunity for our stock to trade in a price range more attractive to a broader array of institutional investors. This increased visibility with institutional investors is critical as we continue our transition from a development-stage company to a fully integrated commercial organization to support the potential launch of cosibelimab."

Recent Corporate Highlights:

·In July 2022, Checkpoint successfully completed two pre-BLA meetings with the FDA (chemistry, manufacturing and controls [CMC] and clinical/non-clinical). Based upon favorable interactions with the agency, the planned BLA submission will include both the metastatic and locally advanced cutaneous squamous cell carcinoma indications. Checkpoint also reached agreement with the FDA on all key aspects discussed with regard to the content of the upcoming BLA submission.
·In November 2022, holders of a majority of the voting power of the capital stock of Checkpoint approved a 1-for-10 reverse stock split of the company’s common stock. Checkpoint expects its common shares will begin trading on a split-adjusted basis on the Nasdaq Capital Market in December 2022. The Board of Directors determined the 1-for-10 ratio to be appropriate in order to improve the marketability and liquidity of Checkpoint’s common stock and to remain in compliance with all of Nasdaq’s continued listing requirements.

Financial Results:

·Cash Position: As of September 30, 2022, Checkpoint’s cash and cash equivalents totaled $20.5 million, compared to $30.9 million at June 30, 2022 and $54.7 million at December 31, 2021, a decrease of $10.4 million for the quarter and a decrease of $34.2 million for the first nine months of 2022.
·R&D Expenses: Research and development expenses for the third quarter of 2022 were $8.9 million, compared to $9.4 million for the third quarter of 2021, a decrease of $0.5 million. Research and development expenses for the third quarter of 2022 included $0.3 million of non-cash stock expenses, compared to $0.2 million for the third quarter of 2021.
·G&A Expenses: General and administrative expenses for the third quarter of 2022 were $1.8 million, compared to $1.9 million for the third quarter of 2021, a decrease of $0.1 million. General and administrative expenses for the third quarter of 2022 included $0.5 million of non-cash stock expenses, compared to $0.6 million for the third quarter of 2021.
·Net Loss: Net loss attributable to common stockholders for the third quarter of 2022 was $10.6 million, or $0.12 per share, compared to a net loss of $11.3 million, or $0.14 per share, in the third quarter of 2021. Net loss for the third quarters of 2022 and 2021 both included $0.8 million of non-cash stock expenses.

On November 8, 2022 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, reported that its product portfolio of FDA-approved brands delivered combined revenues of $11.4 million during the third quarter of 2022 – a 41% increase over the prior year period (Press release, Cumberland Pharmaceuticals, NOV 8, 2022, View Source [SID1234623520]). Cumberland also reported a 19% increase in net revenues for the first nine months of the year compared to the same period in 2021.

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The Company ended the third quarter with $91 million in total assets, $53 million in total liabilities, and $38 million of shareholders’ equity.
"Fueled by initial sales from our newest product Sancuso, we saw tremendous growth during the third quarter and the first nine months of 2022," said A.J. Kazimi, CEO of Cumberland Pharmaceuticals. "As we move through the final quarter of the year, we look forward to building on this success. As always, we remain sharply focused on our mission of improving patient care through the delivery of high-quality medicines."
QUARTER HIGHLIGHTS:
Sancuso Acquisition and Transition
Following its acquisition of Sancuso from Kyowa Kirin, Inc. in January, Cumberland largely completed the transition of the product, assuming responsibilities for its sales, distribution and promotion in the U.S. Sancuso is an FDA-approved prescription patch that prevents nausea and vomiting in patients undergoing certain types of chemotherapy.
Sancuso Promotion
Cumberland formed a new sales division, Cumberland Oncology, to support Sancuso and also entered into an agreement with Verity Pharmaceuticals International Limited for the national co-promotion of the brand.
Under the terms of the agreement, Verity will utilize its established oncology commercial organization to co-promote Sancuso throughout the U.S. Verity completed the training and launched its sales efforts in support of Sancuso during the third quarter of 2022.
RediTrex Agreement with Nordic Pharma
In July 2022, Cumberland entered into an amendment to its agreement with Nordic Pharma addressing the responsibilities and financial arrangements regarding Cumberland’s license to Nordic’s methotrexate line of products for the U.S., which are marketed under the brand name RediTrex.
Based on the amendment, Nordic has the opportunity to assume responsibility for commercializing the methotrexate products in the U.S. after March 31, 2023. Until then, Cumberland will continue to distribute

and support the RediTrex product line. Following the return of the license, Nordic will provide Cumberland with a royalty on their future sales of the product through April 2035.
New Headquarter Office Location
In October 2022, Cumberland relocated its headquarters to the Broadwest campus in the Vanderbilt/West End corridor of Nashville. The new, state-of-the-art headquarters keeps the company close to Vanderbilt University Medical Center, enabling their continued collaboration as Cumberland works to develop new medicines for the future.
The move also allows Cumberland to accommodate recent and future growth. Following the relocation, Cumberland expects to expand its organization to over 100 individuals, with a majority working from the Nashville headquarters.
Ifetroban Clinical Studies
Currently, Cumberland is sponsoring three Phase II clinical trials to evaluate its ifetroban product candidate, for patients with:
•Aspirin-Exacerbated Respiratory Disease ("AERD"), a severe form of asthma;
•Systemic Sclerosis, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs; and
•Cardiomyopathy associated with Duchenne Muscular Dystrophy, a genetic neuromuscular disease that results in deterioration of the skeletal, heart and lung muscles.
The company is also working on an application to the FDA for a fourth Phase II program, which will evaluate the use of ifetroban to treat patients with Progressive Fibrosing Interstitial Lung Diseases.
The company-sponsored AERD study has been closed to enrollment. Once quality checks on the study database are complete, analysis of the results will be conducted and top-line results will then be announced. Once the results of its other sponsored Phase II studies are available, Cumberland will decide on the best development path for the registration of ifetroban.
FINANCIAL RESULTS:
Net Revenue: For the three months ended September 30, 2022, net revenues from continuing operations were $11.4 million, a 41% increase over the prior year period.
Net revenue by product for the third quarter of 2022, included $4.0 million for Sancuso, $3.9 million for Kristalose, $1.9 million for Vibativ and $0.9 million for Caldolor.
Year-to-date 2022 net revenues were $33 million, a 19% increase compared to $28 million for the first nine months of 2021.
Year-to-date net revenues by product were $11.4 million for Kristalose, $10.8 million for Sancuso, $6.0 million for Vibativ and $3.1 million for Caldolor.
Operating Expenses: Total operating expenses for the third quarter were $11.7 million, compared to $9.6 million for the prior year period.
Year-to-date 2022 operating expenses were $36.3 million, compared to $31.0 million for 2021.
Earnings: Net loss for the third quarter of 2022 was $0.4 million, a significant improvement over the $1.1 million net loss during the prior year period.

Adjusted earnings: Adjusted earnings for the third quarter of 2022 were $1.4 million, or $0.10 per share, a significant improvement over the $0.3 million adjusted loss during the same period in 2021. The third quarter 2022 adjusted earnings calculation does not include the benefit of the $1.0 million of Vibativ cost of goods, which were received with the product acquisition. It also does not include the benefit of the $0.4 million of Sancuso cost of goods, which were received with that product’s acquisition.
Cash Flow: Year-to-date cash flow from operations was $5.6 million, a 28% increase over the $4.4 million during the prior year period.
Balance Sheet: At September 30, 2022, Cumberland had $91 million in total assets, including $20 million in cash and cash equivalents. Total liabilities were $53 million, including $18 million outstanding on the Company’s revolving line of credit. Total shareholders’ equity was $38 million.
EARNINGS REPORT CALL:
Cumberland will provide its financial results for the third quarter of 2022 via a conference call today at 4:30 p.m. Eastern Time.
To join the call, register at
https://register.vevent.com/register/BI21ae99e384c446cfb00fbab05f8bf1a3.
Registered participants can dial in from their phone using a dial-in and PIN number that will be provided. They can also choose a "Call Me" option to have the system automatically call them at the start of the conference call.
Available on Cumberland’s website for one year, a replay of the call can be accessed by visiting View Source