Merck Announces Expiration of Hart-Scott-Rodino Act Waiting Period and Extension of Tender Offer to Acquire Acceleron Pharma Inc.

On November 17, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended ("HSR"), in connection with Merck’s pending acquisition of Acceleron Pharma Inc. (Nasdaq: XLRN) expired at 11:59 p.m., Eastern Time, on Nov. 16, 2021 (Press release, Merck & Co, NOV 17, 2021, View Source [SID1234595735]).

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As previously announced on Oct. 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. The expiration of the HSR waiting period satisfies one of the conditions necessary for the consummation of the tender offer. Consummation of the tender offer remains subject to other conditions described in the tender offer statement on Schedule TO filed with the U.S. Securities and Exchange Commission (the "SEC") on Oct. 12, 2021, including the tender of shares representing at least a majority of the total number of Acceleron’s outstanding shares.

Astros Merger Sub, Inc. is extending the tender offer, which was previously scheduled to expire at 5:00 p.m., Eastern Time, on Nov. 18, 2021, until 5:00 p.m., Eastern time, on Nov. 19, 2021 in order to accommodate tendering of Acceleron shares traded on Nov. 17, 2021. The tender offer may be extended further in accordance with the merger agreement and the applicable rules and regulations of the SEC. All other terms and conditions of the tender offer will remain unchanged during the extended period. The acquisition is expected to close in the fourth quarter of 2021.

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 Nov. 16, 2021, the last business day prior to the announcement of the extension of the tender offer, approximately 11,980,722 shares of Acceleron had been validly tendered and received, and not validly withdrawn, pursuant to the tender offer, representing approximately 19.6% of Acceleron’s outstanding shares.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.

Evogene Reports Third Quarter 2021 Financial Results

On November 17, 2021 Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), a leading computational biology company targeting to revolutionize life-science product discovery and development across multiple market segments, reported its financial results for the first nine months and the third quarter of 2021, ended September 30, 2021 (Press release, Evogene, NOV 17, 2021, View Source [SID1234595733]).

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Mr. Ofer Haviv, Evogene’s President and Chief Executive Officer, stated, "I am very pleased with the overall progress and achievement of milestones we see across the board in our subsidiaries and in Evogene itself. Our subsidiaries are progressing according to plan, and we expect to hit additional milestones in the coming months. With this rapid progress, we see significant inherent value developing within each of our subsidiaries.

"As stated previously, we believe that each subsidiary, valued independently, would result in a far greater combined market value for Evogene. In this regard, we wish to unlock the value of our subsidiaries and, as disclosed, are currently examining the possibility of turning one or more of our subsidiaries into public companies. This would allow investors access to the specific subsidiary of interest and the opportunity for the markets to assign it an independent value. We are currently undertaking the required preparations in our subsidiaries to support this process and are reviewing our options regarding investment banks to achieve this target.

"Of course, the decision, if when and how to spin out a subsidiary will depend on many considerations, including market conditions, the subsidiaries financial needs, pipeline maturity, valuation, applicable regulations and other relevant aspects." Mr. Haviv concluded.

Recent Achievements:

Biomica

Immuno-Oncology program – Biomica recently signed an agreement with Rambam Health Care Campus for a clinical trial for its microbiome-based Immuno-Oncology Drug. Biomica expects to initiate its first-in-human, proof-of-concept clinical trials with Rambam later this year and is currently waiting for the approval of the Israeli Ministry of Health in order to begin.

Canonic

MetaYield program – During October 2021, Canonic initiated commercial sales of G200 and G150, part of the G-nnovation series, following positive feedback from a pre-launch campaign, in which these products were marketed in Israel to a limited number of licensed patients.

Canonic’s G200 and G150 are cannabis inflorescence products marketed under the T20/C4 and T15/C3 categories, respectively[1]. This commercial launch, which was originally scheduled for 2022, was moved forward following the aforementioned positive feedback in Israel.

AgPlenus

Appointment of a new CEO – Dr. Brian Ember has been appointed as Chief Executive Officer of AgPlenus. Dr. Ember brings extensive experience in the ag-chemicals industry, holding various senior leadership roles, including Head of Global Portfolio Management and Head of Marketing and Business Development, Americas for Biotalys, an agricultural technology company focused on reinventing food protection with protein-based biocontrol solutions; Senior Director, Business Development for AgriMetis, an innovative crop protection company; and various management roles at BASF and Syngenta.

Lavie Bio

result inoculant (previously LAV.211) – Lavie Bio announced initial commercial launch of its first microbiome-based product for yield improvement – result. This inoculant is being introduced for spring wheat following positive four-year field trials. The first phase of marketing, and initial market penetration, in the upcoming 2022 spring wheat season will be limited to target regions in North Dakota, which is estimated as an overall 6-million-acre spring-wheat market[2]. This initial phase of marketing will be accomplished under a distribution agreement with United Agronomy, as recently announced[3]. Initial sales are expected to be recorded in 2022.

Change in management – Mr. Ido Dor, Lavie Bio’s Chief Executive Officer, has announced that he is stepping down from his position. Evogene thanks Mr. Dor, who has been an integral part of the Evogene group over the past 10 years and significantly contributed to the activities and success over the years. Mr. Dor will continue to serve as a consultant of Lavie Bio. Lavie Bio is currently seeking a replacement for this position and during that period Mr. Ofer Haviv, Evogene’s President and Chief Executive Officer, will serve as an active chairman of Lavie Bio.

Evogene

CRISPR-IL consortium – The Israeli Innovation Authority (IIA) informed Evogene of its decision to fund a second 18-month period of the CRISPR-IL consortium established last year. The consortium’s mission is to develop and validate an end-to-end artificial intelligence (AI) system – "Go-Genome" – for genome-editing in multi-species for applications in pharma, agriculture, and aquaculture.

Beyond activities within the consortium’s scope, companies participating in the consortium may use "Go-Genome" for their own product development activities. In this respect, Evogene is currently conducting various proof-of-concept experiments in plant tissue, examining the feasibility of increasing the production of ingredients such as natural colors and anti-aging agents for food or cosmetic purposes.

Appointment of a new board member – Mr. Dan Falk has been appointed to Evogene’s Board of Directors, commencing November 17, 2021. Mr. Falk has extensive experience of more than 20 years in serving as a financial expert on public and private company boards, most recently on the boards of Nice Ltd., Ormat Technologies Inc. and Innoviz Technologies Ltd.. Additionally, in the past Mr. Falk held various executive positions in Orbotech Ltd. and Sapiens International Corporation.

Consolidated Financial Results Summary

Cash position: Evogene maintains a strong financial position for its activities with $61.6 million in consolidated cash, cash related accounts, bank deposits and marketable securities as of September 30, 2021, of which $9.3 million of Evogene’s consolidated cash is appropriated to its subsidiary, Lavie Bio.

During the first nine months of 2021, the consolidated net cash usage was approximately $17.3 million, or $13.6 million, if excluding Lavie Bio. This is in comparison to the first nine months of 2020, during which the consolidated cash usage was $13.4 million, or $9.3 million, if excluding Lavie Bio. These sums in 2021 exclude $29.6 million net raised through Evogene’s at-the-market, or ATM, offerings (including $2.6 million raised under its current ATM, announced in March 2021) and excludes an additional $1.0 million in proceeds from grants received and exercises of options.

During the third quarter, the consolidated cash usage, was $6.0 million, or $4.6 million, excluding Lavie Bio. This is in comparison to the third quarter of 2020, during which the consolidated cash usage was $4.6 million, or $3.0 million, if excluding Lavie Bio.

The cash burn rate during the first nine months of 2021 and in the third quarter, was higher than during the same period in 2020, for the following reasons:

During the second and third quarter of 2020, the burn rate was relatively low due to certain measures the company initiated to mitigate the impact of the COVID-19 pandemic on the Company.
During the first nine months of 2021 Evogene’s subsidiaries significantly expanded product development activities, including:
– Biomica’s ongoing preparations for the initiation of its first-in-human proof-of-concept study in the immuno-oncology program, later this year.
– Lavie Bio’s activities supporting the commercial launch of its inoculant product branded as result in 2022.
– Canonic’s pre-launch campaign, initiated in September 2021, prior to product commercialization, which took place in Israel during the fourth quarter of 2021.
Management continues to estimate that the cash usage for the full year of 2021 will be within the anticipated range of $20-$22 million. These guidelines exclude the cash usage of Evogene’s subsidiary Lavie Bio.

Research and Development ("R&D") expenses: R&D expenses for the third quarter of 2021, which are reported net of grants received, were $5.8 million, in comparison to $4.0 million in the third quarter of 2020. The increase in R&D expenses was mainly attributed to the product development activities of the Company and its subsidiaries, as mentioned above.

Business Development ("BD") expenses: BD expenses were $0.8 million for the third quarter of 2021, in comparison to $0.6 million in the third quarter of 2020. The increase was attributed mainly to Canonic’s and Lavie Bio’s preparations for commercialization.

General and Administrative ("G&A") expenses: G&A expenses for the third quarter of 2021 were $2.0 million, in comparison to $1.2 million in the third quarter of 2020. The increase was mainly attributed to the increase of the costs of directors’ and officers’ insurance policies and a relative increase in salary expenses following a temporary reduction in such expenses in the corresponding quarter in 2020, due to steps taken to mitigate the financial impact of the COVID-19 pandemic on the Company

Operating loss: Operating loss for the third quarter of 2021 was $8.6 million in comparison to $5.6 million in the third quarter of 2020.

Net loss: The net loss for the third quarter of 2021 was $8.3 million in comparison to a net loss of $5.4 million during third quarter of 2020. The increase in loss is attributed to the increase in product development activities, an increase in commercialization and marketing expenses and an increase in directors’ and officers’ insurance cost.

Replay Information: A replay of the conference call will be available approximately two hours following the completion of the call.

To access the replay, please dial 1-888-326-9310 toll free from the United States, or +972-3-925-5901 internationally. The replay will be accessible through November 19, 2021, and an archive of the webcast will be available on the Company’s website.

EORTC TOLERANCE trial in elderly patients with advanced soft tissue sarcoma receives support from Rising Tide Foundation

On November 17, 2021 EORTC reported that Rising Tide Foundation for Clinical Cancer Research awards a grant 1976 Soft Tissue Bone Sarcoma Group (STBSG) & Quality of Life Group (QLG) TOLERANCE academic clinical trial, a study on health-related quality of life of elderly patients with advanced soft tissue sarcoma (Press release, EORTC, NOV 17, 2021, View Source [SID1234595732]).

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The challenge of treating the fast-growing population of elderly patients with cancer urgently requires adequate treatment, for which guidelines and evidence-based data are lacking.

To date, there is no consensus on the best treatment for elderly patients with inoperable or metastatic soft tissue sarcoma (STS). The numerous side effects associated with the standard doxorubicin-based treatments make the treatment of elderly patients very challenging.

TOLERANCE is an academic clinical trial comparing different treatments for elderly patients with inoperable or metastatic STS, taking into account patients’ priorities in terms of quality of life and the impact of treatment on their ability to conduct daily activities, ultimately aiming to identify the best care for the elderly population.

Rising Tide Foundation awarded €500K to the EORTC 1976-STBSG-QLG study, marking the second collaboration between the two organisations. "Partnering with like-minded organisations is key to addressing unmet patient-centred needs in clinical cancer research, especially in rare cancers and underrepresented populations. The Rising Tide Foundation for Clinical Cancer Research is an invaluable ally. Their substantial support in the EORTC TOLERANCE trial will contribute to an important international randomised clinical trial that will set a new standard of care for the elderly", commented Dr Denis Lacombe, EORTC CEO.

"Rising Tide Foundation for Clinical Cancer Research was founded to help patients improve their quality of life and win the fight against cancer. Our partnership with EORTC will work to propel the research to the next level and bring ground-breaking treatment options to the bedside of patients", explains Wendelin Zellmayer, Director of the RTFCCR.

The study

EORTC 1976-STBSG-QLG TOLERANCE is a 3-arm randomised, open label, phase 3 trial coordinated by the EORTC HQ in Brussels. A total number of 185 patients aged from 65 years-old and diagnosed with advanced or metastatic STS will be enrolled over a period of 3.5 years. The trial will open in 34 reference cancer centres in 9 countries (CY, DK, DE, IT, JO, NL, ES, UK).

The primary objective of the study is to assess whether a higher health-related quality of life (HRQoL), in terms of impact of the disease and its treatment on physical and role functioning, is achieved with metronomic schedules of doxorubicin or cyclophosphamide plus prednisolone versus the standard doxorubicin treatment (3 treatment arms).

Secondary objectives include assessment of whether there is an improvement in quality of life, in terms of impact of the disease and its treatment on social, emotional and cognitive functioning as well as self-reported symptoms, among patients treated in each of the three arms. Furthermore, the study will assess whether there is a difference in the progression free survival, overall survival and tumor response while at the same time monitoring the toxicity profile and tolerability of the three treatment arms.

HRQoL assessment will be performed every 3 weeks during the first 12 weeks and every 12 weeks thereafter until month 12 after start of treatment. Disease evaluation will be performed every 12 weeks until progression.

Patient follow-up duration until primary objective, after LPI (last patient in), is estimated at 25 months to provide the targeted number of events for the study analysis. The overall duration of this study is 7 years and is coordinated by Professor Winette van der Graaf (Netherlands Cancer Institute Amsterdam).

EORTC recognizes patient involvement as a vital component of its clinical research activities, members of the EORTC Group of Patient Experts and Patient Panel were invited to review the patient information sheet and informed consent. Five sarcoma cancer survivors and caregivers have helped us to strike the balance between completeness of the information, document length and relevance of the research objectives for the patients.

"Patient engagement is a key principle of the Rising Tide Foundation for Clinical Cancer Research" explains Shawn Stephenson, Chairman of the Foundation. The TOLERANCE study is a leading example of patient involvement in clinical trial design. "We are excited to partner with EORTC on this multicenter phase 3 study, with the potential to provide better treatment options and improved quality of life for elderly patients."

On the study’s importance, Professor Winette van der Graaf commented: "With a general rise in age, we diagnose more soft issues sarcomas in elderly people than before, but we lack data to support an optimal treatment schedule in case of advanced or metastatic disease in this age group. We are delighted that we will run a study with a novel trial design with widely available drugs, which will increase our knowledge both in term of efficacy and quality of life in this patient population."

Lilly to Participate in Fourth Annual Evercore ISI HealthCONx Conference

On November 17, 2021 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the fourth annual Evercore ISI HealthCONx Conference on Tuesday, Nov. 30, 2021. Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific and medical officer, and president of Lilly Research Laboratories, will participate in a fireside chat at 12:10 p.m., Eastern time (Press release, Eli Lilly, NOV 17, 2021, https://investor.lilly.com/news-releases/news-release-details/lilly-participate-fourth-annual-evercore-isi-healthconx [SID1234595731]).

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

BioVaxys Co-Founder and Chief Medical Officer David Berd, MD, to Present at World Vaccine & Immunotherapy Congress West Coast 2021

On November 17, 2021 BioVaxys Technology Corp. (CSE: BIOV, FRA:5LB,OTCQB:BVAXF) ("BioVaxys" or "Company"), a clinical-stage immunotherapy company, reported that Company Co-Founder and Chief Medical Officer David Berd, MD, will present at the World Vaccine & Immunotherapy Congress West Coast 2021 taking place November 30-December 2, 2021 in San Diego (Press release, BioVaxys Technology, NOV 17, 2021, https://biovaxys.com/2021/11/17/biovaxys-co-founder-and-chief-medical-officer-david-berd-md-to-present-at-world-vaccine-immunotherapy-congress-west-coast-2021/ [SID1234595730]).

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Dr. Berd will discuss the role of immunotherapeutic vaccines in cancer, the potential of haptenized autologous tumor cell vaccines for treating a range of cancer types, and BioVaxys’ advancement of haptenized viral antigens as a platform for addressing SARS-CoV-2, SARS-CoV-1, and other sarbecoviruses.

Details of the presentation are as follows:

Title: Haptenized Vaccines for Viral Diseases & Cancer

When: December 1, 2021 @ 17:10
Where: Lowes Coronado Hotel, San Diego, CA

"BioVaxys is honored to be invited to speak at the World Vaccine & Immunotherapy Congress alongside a prestigious group of vaccine and immunology experts. We look forward to sharing how we are leveraging our haptenized protein platform to create autologous cancer immunotherapies synergistic with checkpoint inhibitors, as well as protein-based vaccines for infectious disease," said Dr. Berd.

A medical oncologist, Dr. Berd has a life-long record of clinical research in medical oncology and cancer immunotherapy. For more than 20 years, he was a professor of medicine at Thomas Jefferson University, where he conducted clinical research on melanoma vaccines. Over the course of his career, Dr. Berd has published more than 85 original papers in numerous medical journals in addition to myriad editorials, reviews, and abstracts. He has 10 issued cancer vaccines patents.