On May 12, 2021 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported financial results for the first quarter ended March 31, 2021 (Press release, TapImmune, MAY 12, 2021, View Source [SID1234579880]).

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"We had a productive first quarter supported by our recently completed financing, strengthening our overall cash position and enabling continued growth and expansion of our Multi-TAA pipeline," said Peter L. Hoang, President & CEO of Marker Therapeutics. "In addition, we continue to make strong progress on both the clinical and manufacturing fronts. In March, we dosed the first patient in the safety lead-in portion of our Phase 2 trial in post-transplant acute myeloid leukemia, or AML, and continue to activate clinical sites. In parallel, we continue to optimize the MT-401 cell therapy manufacturing process, which we believe could result in an increase in the number of T cells available for patient administration—among other benefits—as we prepare to operationalize our new in-house cGMP facility in the first half of the year."

PROGRAM UPDATES

In March 2021, Marker dosed the first patient in the safety lead-in portion of its Phase 2 trial in AML, which is expected to enroll a total of six patients: three of which will be treated with MT-401 manufactured with a legacy reagent, and the remaining three to be treated with study drug manufactured with a new reagent from an alternate supplier.
The clinical operations team has made considerable progress in opening sites to enroll patients for the safety lead-in portion of the AML trial. The Company has also received commitments from additional clinical sites to participate in the Phase 2 AML trial following the safety lead-in phase and anticipates activating a total of approximately 20 sites.
Marker continues to streamline and simplify the MT-401 manufacturing process, which could potentially result in a product with a superior T cell phenotype and improved antigen specificity as compared to the original process. The new process improvements have been updated in the CMC section of the IND and will be used for all patients in the Marker AML Phase 2 clinical trial.
Marker presented early results of robotic automation of T cell generation for the treatment of AML at the American Society of Gene & Cell Therapy 24th Annual Meeting on May 11, 2021. The results will also be presented at the upcoming International Society for Cell & Gene Therapy 2021 Annual Meeting, taking place virtually May 26-28, 2021.
BUSINESS UPDATES

In March, Marker closed an underwritten public offering of 32,282,857 shares of its common stock at a public offering price of $1.75 per share. The gross proceeds to Marker from the offering, before deducting the underwriting discounts and commissions and other offering expenses, were approximately $56.5 million.
The Company is preparing to open its new cGMP manufacturing facility in Houston, TX, which will be used to manufacture study drug for Marker’s Phase 2 AML trial (MT-401) and for future hematological and solid tumor trials, in addition to the potential commercialization of any approved products. Marker initiated the technology transfer from Baylor College of Medicine to the cGMP facility in Q1 2021 and expects the facility to be fully operational in the first half of 2021.
ANTICIPATED PROGRAM MILESTONES

AML Trial Milestones

Complete safety lead-in (6 patients) in Q2 2021
Initiate main portion of Phase 2 trial in Q3 2021
Complete enrollment of 20 patients in main portion of Phase 2 trial in Q4 2021
Topline readout of Group 2 (active disease) in Q1 2022
Manufacturing Milestones

Receive regulatory approval for Marker cGMP in Q2 2021
Manufacture MT-401 at Marker cGMP for Phase 2 AML trial in Q3 2021
FIRST QUARTER 2021 FINANCIAL RESULTS

Cash Position and Guidance: At March 31, 2021, Marker had cash and cash equivalents of $64.5 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses and capital expenditure requirements into Q1 2023.
R&D Expenses: Research and development expenses were $5.6 million for the quarter ended March 31, 2021 compared to $3.8 million for the quarter ended March 31, 2020. The increase was primarily attributable to increases in headcount-related expenses and infrastructure expenses due to growth of research and development operations.
G&A Expenses: General and administrative expenses were $3.1 million for the quarter ended March 31, 2021 compared to $2.8 million for the quarter ended March 31, 2020.
Net Loss: Marker reported a net loss of $8.8 million for the quarter ended March 31, 2021, compared to a net loss of $6.5 million for the quarter ended March 31, 2020.
Conference Call and Webcast
The Company will host a webcast and conference call to discuss its first quarter 2021 financial results and provide a corporate update today at 5:00 p.m. EDT. The webcast will be accessible in the Investors section of the Company’s website at markertherapeutics.com. Individuals can participate in the conference call by dialing 877-407-8913 (domestic) or 201-689-8201 (international) and referring to the "Marker Therapeutics First Quarter 2021 Earnings Call."

On May 12, 2021 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) reported certain differences between its financial forecast on November 5, 2020, for the fiscal year ended March 31, 2021 (April 1, 2020, to March 31, 2021) and the actual results announced today (Press release, Sysmex, MAY 12, 2021, View Source [SID1234579879]). Furthermore, at a meeting of the Managing Board on May 12, 2021, Sysmex resolved to award dividends from surplus as described below, with a record date of March 31, 2021. We intend to propose this payment of dividends from surplus at the General Meeting of Shareholders scheduled for June 25, 2021.

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1. Change from Financial Forecasts
(1) Consolidated Financial Results for Fiscal Year from April 1, 2020, to March 31, 2021

(2) Reason
Consolidated net sales fell below our previous forecast mainly due the impact of the COVID-19 pandemic, which has been more prolonged than expected and led to lower-than-expected sales in the Americas and the Asia Pacific region. On the profit front, lower sales and a deteriorating cost of sales ratio caused gross profit to fall, but selling, general and administrative expenses declined because of restrictions on activities amid the COVID-19 pandemic. As a result, operating profit, profit before tax, and profit attributable to owners of the parent exceeded our previous forecast2.

Dividend from Surplus
(1) Dividend

(2) Reason
In terms of returns to shareholders, we intend to provide a stable dividend on a continuous basis and aim for a consolidated payout ratio of 30% under our basic policy of sharing the successes of our operations in line with business performance.

In accordance with this policy, we have set the ordinary year-end dividend for the fiscal year ended March 31, 2021, at ¥36 per share. Accordingly, annual total dividends will be ¥72 and the consolidated payout ratio will be 45.4%.

On May 12, 2021 Labcorp (NYSE: LH) ("Labcorp") reported that it has priced its offering of $1,000,000,000 in senior notes. The offering consists of two tranches: $500,000,000 aggregate principal amount of 1.550% Senior Notes due 2026 (the "2026 Notes") and $500,000,000 aggregate principal amount of 2.700% Senior Notes due 2031 (the "2031 Notes" and, together with the 2026 Notes, the "Notes") (Press release, LabCorp, MAY 12, 2021, View Source [SID1234579854]). The Notes will bear interest from May 26, 2021, payable semi-annually on June 1 and December 1, commencing on December 1, 2021. The closing of the offering is expected to occur on May 26, 2021, subject to the satisfaction of customary closing conditions. The Notes will be senior unsecured obligations and will rank equally with Labcorp’s existing and future senior unsecured debt.

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Labcorp expects to use the net proceeds of the Notes offering to redeem, prior to maturity, its outstanding 3.20% Senior Notes due Feb. 1, 2022 and 3.75% Senior Notes due Aug. 23, 2022.

The joint book-running managers for the offering are BofA Securities, KeyBanc Capital Markets, and Wells Fargo Securities. The offering will be made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-234633) filed with the Securities and Exchange Commission (the "SEC") on Nov. 12, 2019. A copy of the prospectus and related prospectus supplement may be obtained without charge from the SEC. Alternatively, a copy of the prospectus and related prospectus supplement may be obtained from BofA Securities by calling toll-free 1-800-294-1322, from KeyBanc Capital Markets by calling toll-free 1-866-227-6479, or from Wells Fargo Securities by calling toll-free 1-800-645-3751.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the Notes or any other securities, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The offering of these securities may be made only by means of the prospectus supplement and the accompanying prospectus.

On May 12, 2021 GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases, reported its cash position as of March 31, 2021 and revenues for the first three months of 2021 (Press release, Genfit, MAY 12, 2021, https://ir.genfit.com/news-releases/news-release-details/genfit-reports-first-quarter-2021-financial-information [SID1234579851]).

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Cash position

As of March 31, 2021, the Company’s cash and cash equivalents amounted to €108.9 million compared with €252.0 million as of March 31, 2020 and €171.0 million as of December 31, 2020.

The decrease in cash and cash equivalents between December 31, 2020 and March 31, 2021 takes into account the Company’s partial buyback of its convertible bonds (OCEANEs) in January 2021 for an amount of €47.5 million as well as the expenses related to the convertible bond renegotiation (financial advisors, legal counsel fees, costs related to holding the shareholder and bondholder meetings, etc) which totaled €2.9 million tax included, and for which a significant portion was already paid at March 31, 2021.

Revenues
Revenues for the first three months of 2021 amounted to €1 thousand compared to €102 thousand for the same period in 2020. Revenues for the first three months of 2020 mainly consisted of revenues from services provided to Terns Pharmaceuticals pursuant to the collaboration and license agreement in relation to their clinical trials.

Reminder

On September 30, 2020, GENFIT announced its plan to reduce its cash burn by 50% by 2022 compared to the cash burn before the publication of the RESOLVE-IT Phase 3 data readout.

The Company reiterates its goal to reduce the cash burn rate from €110 million annually before our Phase 3 data, to approximately €45 million annually, beginning in 2022. 2021 will be a transition year with a cash burn of approximately €75 million (excluding the partial OCEANEs buyback transaction for €47.48 million in cash1) mainly due to the residual expenses related to the termination of the RESOLVE-IT clinical trial, and to costs associated with the workforce reduction plan.

On May 12, 2021 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported its financial results for the first quarter 2021 and business highlights, including an update on its progress with fadraciclib and CYC140, Cyclacel’s novel CDK2/9 and PLK1 inhibitors, respectively (Press release, Cyclacel, MAY 12, 2021, View Source [SID1234579849]).

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"During the quarter, we have made significant progress in bringing our two oral targeted development candidates into mid-stage clinical development. Following recent FDA authorization of our IND for oral fadraciclib, we will finalize contract discussions with sites and open our multi-cohort Phase 1b/2 study in patients with solid tumors," said Spiro Rombotis, President and Chief Executive Officer. "We believe fadraciclib is establishing a strong position among compounds in clinical development that specifically address cancer resistance mechanisms, including suppression of MCL1, MYC and cyclin E. A recent publication identified potential utility of CDK9 inhibitors in KRAS mutant colorectal cancer, one of the tumor types in our study. Together with our oral CYC140 PLK1 inhibitor program, which has shown in preclinical models that KRAS mutant cancers are sensitive to CYC140 inhibition, we hope to provide valuable alternatives to patients with these difficult to treat malignancies. After strengthening our balance sheet in the quarter, we are executing a precision medicine strategy to achieve multiple milestones and data read outs over the next two years."

Key Corporate Highlights

CYC065-101 Phase 1b/2 oral fadraciclib in advanced solid tumors – announced that the U.S. Food & Drug Administration (FDA) has authorized Cyclacel’s Investigational New Drug (IND) application for oral fadraciclib to proceed. This Phase 1b/2 registration-directed trial includes multiple cohorts defined by histology thought to be sensitive to the drug’s mechanism of action and informed by the clinical activity of fadraciclib in MCL1, MYC and cyclin E amplified cancers. The cohorts include breast, colorectal (including KRAS mutant), endometrial/uterine, ovarian cancers and certain lymphomas. The study design also includes a basket cohort which will enroll patients with relevant biomarkers to the drug’s mechanism regardless of histology.

A recent publication by researchers led by Frank McCormick, PhD of University of California San Francisco and NCI’s Frederick National Lab for Cancer Research reported that overactive KRAS mutants are impeded by CDK9 inhibition1. These data expand on previous findings, which show that dual CDK2/9 inhibition is an optimal strategy to treat colorectal cancer2, that KRAS mutant pancreatic cancer is sensitive to CDK9 inhibition3, and that fadraciclib showed efficacy against KRAS mutant lung cancer in preclinical PDX models4. Collectively these publications suggest the potential for the therapeutic use of fadraciclib in KRAS-mutated cancers, including colorectal, lung and pancreatic.

CYC140 PLK1 inhibitor program – commenced IND-directed activities and manufacturing of clinical trial supplies for oral CYC140. Initial data in preclinical models show that KRAS mutant cancers are sensitive to oral CYC140 inhibition.

Phase 1b/2 Investigator Sponsored Trial (IST) of sapacitabine-olaparib combination in patients with BRCA mutant metastatic breast cancer – investigators reported that out of 9 patients enrolled, 5 have achieved partial response (PR), 3 stable disease (SD), and one patient has progressed.

Announced the closing of an underwritten public offering for net proceeds to the Company of approximately $13.5 million, after deducting placement agent fees and other offering expenses. Existing and new institutional investors participated in the offering. In addition, the Company received approximately $4.5 million in the quarter through warrant exercises.

Key Near-Term Business Objectives and Expected Timeline

1H 2021

First patient dosed with oral fadraciclib in Phase 1b/2 advanced solid tumor study
2H 2021

First patient dosed with oral fadraciclib in Phase 1b/2 leukemia study
First patient dosed with oral CYC140 in Phase 1/2 advanced solid tumor study
1H 2022

First patient dosed with oral CYC140 in Phase 1/2 leukemia study
Phase 1 data with oral fadraciclib in advanced solid tumor study
Update data from the Phase 1b/2 IST of sapacitabine-olaparib combination in patients with BRCA mutant metastatic breast cancer when reported by the investigators
Financial Highlights

As of March 31, 2021, cash and cash equivalents totaled $47.8 million, compared to $33.4 million as of December 31, 2020. The increase of $14.4 million was primarily due to $18.0 million of net cash provided by financing activities, offset by net cash used in operating activities of $3.6 million. There were no revenues for each of the three months ended March 31, 2021 and 2020.

Research and development expenses were $2.6 million for the three months ended March 31, 2021 as compared to $1.1 million for the same period in 2020. Research and development expenses relating to the CDK inhibitor program increased by approximately $0.8 million for the three months ended March 31, 2021 as clinical evaluation of fadraciclib is progressing.

General and administrative expenses for the three months ended March 31, 2021 were $1.7 million, compared to $1.3 million for the same period of the previous year due to an increase in legal and professional expenses and recruitment costs.

Total other income, net, for the three months ended March 31, 2021 was $0.1 million, compared to $0.9 million for the same period of the previous year. The decrease of $0.8 million for the three months ended March 31, 2021 is primarily related to income received under an Asset Purchase Agreement with Thermo Fisher Scientific Inc.

United Kingdom research & development tax credits were $0.7 million for the three months ended March 31, 2021, as compared to $0.3 million for the same period in 2020 as a direct consequence of increased qualifying research and development expenditure.

Net loss for the three months ended March 31, 2021 was $3.5 million, compared to $1.2 million for the same period in 2020.

The Company raised net proceeds of approximately $13.5 million from an equity financing in March 2021. The Company also received an additional $4.5 million of proceeds from warrant exercises.

The Company estimates that cash resources of $47.8 million as of March 31, 2021 will fund currently planned programs through early 2023.