Evotec and Bristol Myers Squibb extend and expand strategic partnership in protein degradation

On May 9, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that the Company has extended and expanded its partnership with Bristol Myers Squibb (NYSE:BMY) in targeted protein degradation, originally signed in 2018 (Press release, Evotec, MAY 9, 2022, View Source [SID1234614065]). The initial collaboration has proven to be highly productive in generating a promising pipeline of molecular glue degraders. Based on this success, Bristol Myers Squibb and Evotec extend and expand this partnership for an additional 8 years with the goal to further broaden and deepen the strategic alliance.

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Molecular glue degraders are small, drug-like compounds that induce interactions between an E3 ubiquitin ligase and a molecular target. This induced interaction results in ubiquitination and subsequent degradation of the recruited protein leading to long-lasting therapeutic effects. Bristol Myers Squibb is a leader in this field based in particular on its unique library of cereblon E3 ligase modulators (CELMoD). Under the terms of the agreement, both parties will leverage all of Evotec’s proprietary EVOpanOmics and EVOpanHunter platforms as well as AI/ML-based drug discovery and development platforms.

Evotec receives an upfront payment of $ 200 m and expects to obtain further performance-based, near-term and programme-based milestone payments, resulting in a deal potential of $ 5 bn with additional tiered royalties on product sales.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, said: "Bristol Myers Squibb is the pioneer and industry-leader in the field of molecular glue degraders. Molecular glues are one of the most exciting new modalities as they can be developed into highly selective and potent degraders of high-value therapeutic targets, even reaching molecular targets which have been deemed undruggable by conventional means. We are extremely excited about the opportunity to significantly extend and expand our strategic partnership with Bristol Myers Squibb into 2030 and possibly beyond."

PureTech Announces Share Buyback Programme Update

On MAY 9, 2022 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, reported that, in connection with the $50 million share buyback programme announced on 5 May 2022, it is now commencing purchases of the Company’s ordinary shares of one pence each ("Ordinary Shares") (the "Programme") (Press release, PureTech Health, MAY 9, 2022, View Source [SID1234613864]). The Programme will be carried out in tranches and is in line with the Company’s previously announced capital allocation strategy to balance investment in the continued growth of its business with potential returns of capital to shareholders.1

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PureTech plans to execute the buyback in two tranches. In respect of the first tranche, PureTech announces that it has entered into an irrevocable non-discretionary instruction with Jefferies International Limited ("Jefferies") in relation to the purchase by Jefferies, acting as principal during the period commencing on 9 May 2022 and ending on the earlier of exhaustion of funds associated with the first tranche or 8 May 2023 (subject to any regulatory objections or concerns), of Ordinary Shares for an aggregate consideration (excluding expenses) of no greater than $25 million and the simultaneous on-sale of such Ordinary Shares by Jefferies to PureTech. Jefferies will make its trading decisions in relation to the Ordinary Shares independently of, and uninfluenced by, the Company. Purchases may continue during any close period to which the Company is subject. It is anticipated that the second tranche, subject to a separate instruction, will commence promptly on completion of the first tranche, subject to renewal of the requisite authority at the 2022 AGM.

The maximum number of Ordinary Shares that can be purchased under the first tranche of the Programme is 28,589,874 Ordinary Shares (being the maximum number of shares the Company is authorised to purchase pursuant to the authority granted by shareholders at the Company’s annual general meeting held on May 27, 2021).

The purpose of the Programme is to return capital to shareholders in line with the Company’s capital allocation strategy and to enable the Company to meet obligations arising from employee share option programmes, or other allocations of shares to employees of the Company or to members of the administrative, management or supervisory bodies of the Company, or an associate of the Company. Any shares repurchased for this purpose will be held in treasury.

Any purchase of Ordinary Shares under the first tranche of the Programme will be carried out on the London Stock Exchange and any other UK recognised investment exchange which may be agreed, in accordance with pre-set parameters and in accordance with, and subject to limits, including those limits related to daily volume and price, prescribed by the Company’s general authority to repurchase Ordinary Shares granted by its shareholders at its most recent annual general meeting on May 27, 2021, Chapter 12 of the Financial Conduct Authority’s UK Listing Rules, Article 5(1) of Regulation (EU) No. 596/2014 (as incorporated into UK domestic law by the European Union (Withdrawal) Act 2018) and Commission Delegated Regulation (EU) 2016/1052 (as incorporated into UK domestic law by the European Union (Withdrawal) Act 2018).

PureTech will announce any market repurchases of Ordinary Shares no later than 7.30 a.m. BST on the business day following the calendar day on which the repurchase occurred.

ORIC Pharmaceuticals Reports First Quarter 2022 Financial Results and Operational Update

On May 9, 2022 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported financial results and operational updates for the quarter ended March 31, 2022 (Press release, ORIC Pharmaceuticals, MAY 9, 2022, View Source [SID1234613920]).

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"We continue to make steady progress in advancing our pipeline of novel oncology candidates," said Jacob M. Chacko, MD, chief executive officer, "We expect to report initial data from our three ongoing studies in the first half of 2023, which includes our Phase 1b single agent trials for ORIC-533, our orally bioavailable CD73 inhibitor, ORIC-114, our brain penetrant EGFR/HER2 inhibitor, and ORIC-944, our embryonic ectoderm development (EED) inhibitor."

First Quarter 2022 and Other Recent Highlights

Preclinical Data Presented at AACR (Free AACR Whitepaper): In April 2022, ORIC disclosed new preclinical data in three poster presentations and one oral presentation at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

ORIC-533: Oral Small Molecule CD73 Inhibitor
ORIC-533 is a highly potent, orally bioavailable small molecule inhibitor of CD73 that has demonstrated more potent adenosine inhibition in preclinical studies compared to an antibody approach and other small molecule inhibitors of the adenosine pathway. In preclinical studies, ORIC-533 overcame immune suppression and triggered significant lysis and cell death of multiple myeloma cells in an assay comprised of autologous bone marrow microenvironment. A Phase 1b trial with ORIC-533 as a single agent in multiple myeloma is enrolling patients, and the company expects to report initial Phase 1b data from this trial in the first half of 2023.

ORIC-114: EGFR/HER2 Inhibitor
ORIC-114 is a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations. In preclinical studies, ORIC-114 achieved tumor regressions in an EGFR exon 20 NSCLC model with superior efficacy relative to CLN-081 and demonstrated greater anti-tumor activity compared to mobocertinib (TAK-788) in an intracranial NSCLC model. A Phase 1b trial with ORIC-114 as a single agent is enrolling patients with advanced solid tumors with EGFR or HER2 exon 20 alterations or HER2 amplification and allows for patients with CNS metastases that are either treated or untreated but asymptomatic. The company expects to report initial Phase 1b data from this trial in the first half of 2023.

ORIC-944: PRC2 Inhibitor
ORIC-944 is a potent and selective allosteric inhibitor of polycomb repressive complex 2 (PRC2) that targets its regulatory embryonic ectoderm development (EED) subunit and has demonstrated single agent efficacy in multiple enzalutamide-resistant prostate cancer models in preclinical studies. A Phase 1b trial with ORIC-944 as a single agent is enrolling patients with metastatic prostate cancer, and the company expects to report initial Phase 1b data from this trial in the first half of 2023.

PLK4 Inhibitor Program
In March, the company announced a small molecule therapeutic program intended to address a mechanism of innate resistance found in a subset of breast cancers, specifically a synthetic lethal interaction of polo-like kinase 4 (PLK4) inhibition in tumors bearing a TRIM37 DNA amplification. ORIC discovered novel, potent, orally bioavailable small molecule inhibitors of PLK4 that are highly selective and achieved strong anti-tumor activity of TRIM37 high xenograft tumors, with corresponding pharmacodynamic effects and no body weight loss. The PLK4 inhibitor program is currently in lead optimization.

Anticipated Program Milestones

ORIC anticipates the following upcoming milestones:

ORIC-533: Initial Phase 1b data in 1H 2023
ORIC-114: Initial Phase 1b data in 1H 2023
ORIC-944: Initial Phase 1b data in 1H 2023
First Quarter 2022 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $256.2 million as of March 31, 2022, which the company expects will fund its current operating plan into the second half of 2024.
R&D Expenses: Research and development (R&D) expenses were $16.8 million for the three months ended March 31, 2022, compared to $11.7 million for the same period in 2021, an increase of $5.1 million. The increase was primarily driven by an increase in external expenses related to the advancement of ORIC-533, ORIC-114, ORIC-944 and our other product candidates of $4.6 million, offset by a decrease in ORIC-101 costs of $0.7 million due to the discontinuation of the program in the first quarter of 2022. Higher internal expenses related to higher personnel costs, including additional non-cash stock-based compensation of $0.5 million, also contributed to the increase in research and development expenses.
G&A Expenses: General and administrative (G&A) expenses were $6.4 million for the three months ended March 31, 2022, compared to $4.9 million for the same period in 2021, an increase of $1.6 million. The increase was primarily due to higher personnel costs, including additional non-cash stock-based compensation of $0.7 million.

Labcorp Acquires Diagnostic Clinical Laboratory Services From AtlantiCare

On May 9, 2022 Labcorp (NYSE: LH), a leading global life sciences company, and AtlantiCare, the largest health care organization in southern New Jersey, reported that they have closed a transaction to expand their long-term strategic relationship (Press release, LabCorp, MAY 9, 2022, View Source [SID1234613936]). Labcorp will acquire select assets from AtlantiCare’s clinical outreach business, which serves the AtlantiCare Physician Group and Affiliated Physicians and their patients across southern New Jersey. The transaction is the latest in a series of new and expanded collaborations between Labcorp and health systems across the country, demonstrating the value that Labcorp brings to improve laboratory services and help enhance patient care.

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"Labcorp is keenly focused on delivering value to our health system partners, physicians, and the broader community," said Bill Haas, senior vice president of Labcorp’s Northeast Division. "Our multi-year, comprehensive relationship with AtlantiCare is a prime example of that focus. Through this enhanced outreach relationship, Labcorp is furthering its commitment to AtlantiCare’s patients and providers to improve health and improve lives in the region, including through increased diagnostic testing access."

AtlantiCare’s patients will be able to access Labcorp’s expansive test menu and services through the company’s extensive network of patient service centers including Labcorp at Walgreens. Many of AtlantiCare’s physician office phlebotomy sites and outpatient collection services will now be operated by Labcorp.

"As a health system, we are committed to evolving the care and services we provide," said Lori Herndon, MBA, BSN, RN, president and CEO of AtlantiCare. "Our past collaboration with Labcorp has helped us provide comprehensive testing services to meet the growing needs of our community. Most recently, this has included Labcorp’s ability to provide critical testing, collections, lab equipment and supplies throughout the pandemic. This collaboration will enhance the breadth and quality of laboratory services patients and healthcare providers have come to expect from both of our organizations."

Celsion Corporation to Hold First Quarter 2022 Financial Results and Business Update Conference Call on Monday, May 16, 2022

On May 9, 2022 Celsion Corporation (NASDAQ: CLSN), a clinical-stage development company focused on DNA-based immunotherapy and next-generation vaccines, reported that the Company will host a conference call at 11:00 a.m. ET on Monday, May 16, 2022 to discuss financial results for the first quarter ended March 31, 2022 and provide an update on product development programs with GEN-1, a DNA-based immunotherapy, currently in Phase II development for the localized treatment of advanced ovarian cancer and PLACCINE, a proprietary synthetic, non-viral vaccine delivery technology currently in preclinical studies (Press release, Celsion, MAY 9, 2022, View Source [SID1234613952]). Celsion has two platform technologies for the development of novel nucleic acid-based immunotherapies and next generation infectious vaccines.

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To participate in the call, interested parties may dial 1-888-394-8218 (Toll-Free/North America) or +1-323-794-2588 (International/Toll) and ask for the Celsion Corporation First Quarter 2022 Earnings Call (Conference Code: 7615593) to register ten minutes before the call is scheduled to begin. The call will also be broadcast live on the internet at www.celsion.com. The call will be archived for replay on Monday, May 16, 2022, and will remain available until May 30, 2022. The replay can be accessed at +1-719-457-0820 or 1-888-203-1112 using Conference ID: 7615593. An audio replay of the call will also be available on the Company’s website, www.celsion.com, for 90 days after 2:00 p.m. ET Monday, May 16, 2022.