On October 29, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that it has withdrawn its Premerger Notification and Report Form under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the "HSR Act"), in connection with Merck’s pending acquisition of Acceleron Pharma Inc. (Nasdaq: XLRN) (Press release, Merck & Co, OCT 29, 2021, View Source [SID1234592187]). As previously announced on October 12, 2021, Merck commenced, through a subsidiary, Astros Merger Sub, Inc., a cash tender offer to purchase all outstanding shares of common stock of Acceleron, for $180 in cash, without interest and less any required tax withholding.

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Merck has elected to withdraw its Premerger Notification and Report Form, which was initially filed on October 14, 2021, to provide the Federal Trade Commission (the "FTC") with additional time for review, and expects to refile such form on or about November 1, 2021. Following the refiling, the waiting period applicable to the pending acquisition will expire at 11:59 p.m., Eastern time, on or about November 16, 2021. The acquisition is expected to close in the fourth quarter of 2021.

Consummation of the tender offer remains subject to, among other conditions, the expiration or termination of the applicable waiting period under the HSR Act. As a result, Astros Merger Sub, Inc. is extending the tender offer, which was previously scheduled to expire at 5:00 p.m., Eastern Time, on November 10, 2021, until 5:00 p.m., Eastern time, on November 18, 2021. The tender offer may be extended further in accordance with the merger agreement and the applicable rules and regulations of the U.S. Securities and Exchange Commission (the "SEC"). All other terms and conditions of the tender offer will remain unchanged during the extended period.

The Depositary for the tender offer is Computershare Trust Company, N.A., c/o Voluntary Corporate Actions, P.O. Box 43011, Providence, RI 02940-3011. The Depositary has advised Merck that, as of 5:00 p.m., Eastern time, on October 28, 2021, the last business day prior to the announcement of the extension of the tender offer, approximately 8,395,093 shares of Acceleron had been validly tendered and received, and not validly withdrawn, pursuant to the tender offer, representing approximately 13.7% of Acceleron’s outstanding shares. Stockholders who have already tendered their shares do not need to retender such shares or take any other action as a result of the extension of the tender offer.

The Information Agent for the tender offer is Innisfree M&A Incorporated, 501 Madison Avenue, 20th floor, New York, NY 10022. The tender offer materials may be obtained at no charge by directing a request by mail to Innisfree M&A Incorporated or by calling toll free at (877) 800-5195, and may also be obtained at no charge at the website maintained by the SEC at www.sec.gov.

On October 29, 2021 Leidos Holdings, Inc. (NYSE:LDOS) reported that its Board of Directors has declared a quarterly cash dividend of $0.36 per outstanding share of common stock of Leidos Holdings, Inc (Press release, Leidos, OCT 29, 2021, View Source [SID1234592185]). The cash dividend is payable on December 30, 2021 to stockholders of record as of the close of business on December 15, 2021.

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On October 29, 2021 Kureha Corporation reported that it has upgraded its earnings forecast for the first six months of the fiscal year ending March 31, 2022 (FY2021) in light of recent performance trends (Press release, Kureha Corporation, OCT 29, 2021, View Source [SID1234592184]). Changes from the previous earnings forecast, which was announced on May 12, 2021, are as follows.

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1. Earnings forecast for the first six months of FY2021 (April 1-September 30, 2021)

2. Factors affecting the forecast revision For the first six months of FY2021, revenue is expected to exceed our previous forecast due primarily to steady volume growth of ‘NEW Krewrap’ in the Specialty Plastics segment and poly-vinylidene fluoride resins (for lithium-ion battery binder applications) in the Advanced Materials segment, as well as an advanced delivery of agrochemicals in the Specialty Chemicals segment. We also expect higher operating profit driven by increased high-margin product volumes and a decrease in sales and general administrative expenses, which will be spent in the second half of the year. Subsequently, profit before taxes and profit for the period attributable to the owners of Kureha Corporation are also projected to rise above previous expectations.

Kureha is currently reviewing its FY2021 full-year forecast and will provide an update when the company reports FY2021 half-year results (scheduled for November 9, 2021).

Cautionary note:
Above forecasts are forward-looking in nature and based on assumptions and information acquired by Kureha as of the date of this announcement. Actual results may differ due to unforeseeable risks and factors.

On October 29, 2021 Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an oncology-focused drug development company, reported an update on the ongoing development of its product candidates for the quarter ending 30 September 2021 (Press release, Kazia Therapeutics, OCT 29, 2021, View Source [SID1234592183]).

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Key Points

GBM AGILE study continues to make good progress, with activation of Canada expected in 4Q CY2021, and activation of Europe and China expected in CY2022.

EVT801 phase I study remains on track to commence recruitment by end of CY2021. Regulatory approval has been received from the French competent authority.

Final data from paxalisib phase II study in glioblastoma expected during 4Q CY2021.

Kazia CEO, Dr James Garner, commented, "We have continued to make good progress on all fronts during the third quarter. The last few months have been characterized by a focus on operational matters. As we move towards the end of CY2021, we expect to report a number of important data read-outs, and to commence recruitment to the phase I study of EVT801. Delivery of these milestones will neatly conclude a tremendously productive year for the company."

Good Progress in GBM AGILE Pivotal Study

Kazia previously provided an update on progress with the GBM AGILE pivotal study (NCT03970447) in June 2021. Since then, the study has continued to progress well, with almost thirty hospitals in the United States now recruiting to the paxalisib arm. The study is expected to open to the paxalisib arm in Canada during 4Q CY2021, and in Europe and China next year. The respective regulatory submissions in Europe and China have been submitted and are undergoing review by regulatory agencies.

Kazia has brought forward manufacture of an additional batch of paxalisib investigational product, and this is expected to become available for use in the study in 1Q CY2022.

EVT801 Phase I Study on Track to Commence in 4Q CY2021

On 2 September 2021, Kazia announced that the phase I study of EVT801 had received regulatory approval from L’Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), the French regulatory agency. The study has since also received approval from the Committee for the Protection of Persons (CPP), which serves as a centralised ethics committee for both of the participating sites. Commencement of recruitment to the study is expected by the end of CY2021.

A team of Evotec scientists who led the early development of EVT801 have been working to compile their research into a scientific paper, which is expected to be submitted for publication in a peer-reviewed academic journal during 4Q CY2021.

Multiple Data Read-Outs from Paxalisib Program

The phase II study of paxalisib (NCT03522298) is moving towards completion, and Kazia expects to share top-line final data during 4Q CY2021, as previously indicated. In addition, the company expects to receive initial data from several ongoing investigator-initiated studies and will provide this to investors as soon as it is available.

Completion of Human ADME Study

Kazia indicated in its Appendix 4C for the June quarter that it had initiated a human ADME (absorption, distribution, metabolism, elimination) study to satisfy certain standard regulatory requirements for approval of a new pharmaceutical product (NCT05012670). This study has completed the in-life phase, and all results appear to lie within expected parameters. The company expects to conclude analysis of the study early in CY2022 and to share results with FDA shortly thereafter.

Impact of COVID-19

The company has no revisions to its prior guidance concerning COVID-19. At present, there is limited operational impact, but Kazia continues to monitor the situation closely.

Financial Update

As noted in the accompanying Appendix 4C, the company’s cash position as at 30 September 2021 was AU$ 19.6 million, versus AU$ 27.6 million at 30 June 2021. The company calculates our cash position will finance operations on a forward-looking basis through to 4Q CY2022.

On October 29, 2021 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported financial results for the quarter ended September 30, 2021 (Press release, ImmunoGen, OCT 29, 2021, View Source [SID1234592182]).

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"We look forward to announcing top-line data from our pivotal SORAYA trial this quarter, including data on the primary endpoint of overall response rate and key secondary endpoint of duration of response. With positive data, we will move quickly to complete the BLA, with the goal of submitting the filing in the first quarter of 2022," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "In addition to SORAYA, we continue to advance a broad program to establish mirvetuximab as the standard of care for patients with FRα-positive ovarian cancer. Our confirmatory MIRASOL trial is enrolling at over 160 sites in 18 countries in North America, Europe, Asia, and Australia, and we have initiated the PICCOLO trial, which could support label expansion in recurrent platinum-sensitive ovarian cancer. Beyond mirvetuximab monotherapy, the first patients have been enrolled in the large investigator-sponsored studies evaluating mirvetuximab combined with carboplatin in both the neoadjuvant and recurrent platinum-sensitive settings to support our objective of making mirvetuximab the combination agent of choice in ovarian cancer, and we look forward to sharing our label-enabling combination strategy early next year."

Enyedy continued, "In addition, our IMGN632, IMGC936, and IMGN151 programs are advancing as planned. We anticipate presenting data on IMGN632 in AML at ASH (Free ASH Whitepaper) in December, have escalated dosing in multiple solid tumors with our ADAM-9 targeting ADC, IMGC936, and expect to file the IND for IMGN151, our next-generation FRα-targeting ADC, by year-end. As we close out 2021, we remain focused on execution and look forward to transforming ImmunoGen into a fully integrated oncology company with the potential for commercial launch next year."

RECENT PROGRESS

Further enrolled patients in the confirmatory MIRASOL study for mirvetuximab.
Initiated PICCOLO, a single-arm study of mirvetuximab monotherapy in high folate receptor alpha (FRα) recurrent platinum-sensitive ovarian cancer.
Enrolled the first patients in the investigator-sponsored trials of mirvetuximab plus carboplatin in a single-arm study in the neoadjuvant setting and a randomized study in patients with recurrent platinum-sensitive ovarian cancer.
Advanced accrual in the pivotal 801 Phase 2 study, now known as CADENZA, of IMGN632 in frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Continued patient enrollment in the 802 Phase 1b/2 study of IMGN632 in combination with Vidaza (azacitidine) and Venclexta (venetoclax) in R/R acute myeloid leukemia (AML) patients and as a monotherapy in minimal residual disease positive (MRD+) AML.
Escalated dosing in the Phase 1 study of IMGC936 in multiple solid tumor types.
Progressed activities to support an investigational new drug (IND) application for IMGN151.
Appointed Helen M. Thackray, MD, to the Board of Directors.
ANTICIPATED UPCOMING EVENTS

Release top-line data from the pivotal SORAYA study this quarter, with the goal of submitting the biologics license application (BLA) in the first quarter of 2022 to support potential accelerated approval in 2022.
Present initial AML combination data for IMGN632 at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.
Submit the IND application for IMGN151 by the end of 2021.
Complete dose-escalation in the Phase 1 study evaluating IMGC936, with initial data anticipated in 2022.
Generate top-line data for the confirmatory MIRASOL study in the third quarter of 2022.
FINANCIAL RESULTS

Revenues for the quarter ended September 30, 2021 were $9.2 million, compared with $18.2 million for the quarter ended September 30, 2020. This decrease was driven by a reduction in non-cash royalty revenue due to the completion of the first tranche of payments under the 2015 transaction covering the sale of Kadcyla royalties. Revenues for the quarter ended September 30, 2021 also included recognition of an anticipated $2.5 million partner development milestone fee.

Operating expenses for the third quarter of 2021 were $43.4 million, compared with $34.9 million for the same quarter in 2020. Research and development expenses rose to $33.1 million for the third quarter of 2021, compared with $24.7 million for the third quarter of 2020, driven by increases in clinical trial expenses, personnel and temporary staffing costs, and third-party service fees in support of commercial readiness. General and administrative expenses were essentially flat at $10.3 million and $10.2 million for the third quarters of 2021 and 2020, respectively.

Net loss for the third quarter of 2021 was $37.3 million, or $0.18 per basic and diluted share, compared to a net loss of $22.4 million, or $0.13 per basic and diluted share, for the third quarter of 2020. Weighted average shares outstanding increased to 204.8 million for the 2021 period from 174.5 million in the prior year.

ImmunoGen had $245.8 million in cash and cash equivalents as of September 30, 2021, compared with $293.9 million as of December 31, 2020, and had $2.1 million of convertible debt outstanding as of December 31, 2020. There was no convertible debt outstanding as of September 30, 2021. Cash used in operations was $123.5 million for the first nine months of 2021, compared with cash used in operations of $87.2 million for the same period in 2020. Capital expenditures were $(1.1) million for the first nine months of 2021, compared with net proceeds from the sale of equipment of $0.6 million for the first nine months of 2020.

During the quarter ended September 30, 2021, the Company sold 2.2 million shares of its common stock through its At-the-Market (ATM) facility, generating gross proceeds to the Company of approximately $13 million. In August 2021, the Company entered into a Securities Purchase Agreement pursuant to which the Company agreed to sell to an investor a warrant to purchase up to an aggregate of 5,434,782 shares of the Company’s common stock for a nominal value, generating additional gross proceeds of approximately $30 million.

FINANCIAL GUIDANCE

ImmunoGen has updated its financial guidance for 2021 and now expects:

revenues between $65 million and $75 million;
operating expenses between $190 million and $200 million; and
cash and cash equivalents at December 31, 2021 to be between $190 million and $200 million.
ImmunoGen expects that its current cash will fund operations into the fourth quarter of 2022.

CONFERENCE CALL INFORMATION

ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, dial (877) 621-5803; the conference ID is 1587202. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.