On December 6, 2021 Odyssey Acquisition S.A. ("Odyssey"), a Euronext Amsterdam-listed special-purpose acquisition company, and BenevolentAI, a leading clinical-stage AI drug discovery company, reported that they have entered into a definitive agreement for a business combination (the "Combination") (Press release, BenevolentAI, DEC 6, 2021, https://finance.yahoo.com/news/odyssey-announces-agreement-combine-benevolentai-060000260.html [SID1234596481]). The terms of the Combination value BenevolentAI at a pre-money valuation of €1.1 billion and a post-money valuation of up to €1.5 billion. Net transaction proceeds are expected to be up to €390m[1] including €135m of fully-committed PIPE and €300m of gross cash held in escrow by Odyssey. The funds will be used to accelerate BenevolentAI’s development, scale-up its clinical pipeline, continue investment in its technology platform, consolidate its leadership position in AI-enabled drug discovery and deliver multiple value inflection points in the near future.

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Joanna Shields, Chief Executive Officer, BenevolentAI, said: "We have built BenevolentAI into a category defining business by pioneering a revolutionary approach to drug discovery and development. Our AI platform empowers scientists to leverage biomedical and experimental data at scale to understand the underlying causes of disease and develop more effective medicines, faster. Every drug in our pipeline of 20+ programmes has been generated by the Benevolent Platform which has a proven track record of scientifically validated discoveries, both in-house and in partnership with leading pharmaceutical companies. The combination with Odyssey will allow us to scale our vision and ambition of uniting purposeful technology and cutting-edge science to discover life-changing medicines."

Dr François Nader, Chairman of BenevolentAI, said: "BenevolentAI stands out at the forefront of the emerging sector of AI-driven drug discovery, with its innovative R&D platform and focus on mechanism-based drug discovery. Through its impressive track record, BenevolentAI has demonstrated the value of its platform in facilitating new discoveries for challenging diseases that have defied conventional research efforts. BenevolentAI is a company with significant growth potential, and the combination with Odyssey will further accelerate the company’s ambitious plans to scale its platform and broaden its pipeline. Investments from existing shareholder Temasek, our strategic partner AstraZeneca and new shareholders Ally Bridge and Invus are a clear vote of confidence in BenevolentAI and its growth prospects."

Michael Zaoui, Chairman of Odyssey, said: "We established Odyssey with the objective of supporting and bringing to the European capital markets promising European growth companies in the healthcare and/or technology sectors. BenevolentAI is positioned at the convergence of these two sectors, is a proven leader in the emerging area of AI-driven drug discovery, and is led by a very experienced management team. We are convinced BenevolentAI offers superior growth prospects in a sector which itself is at an inflection point. We see our combination with BenevolentAI as a compelling investment opportunity and are convinced that this transaction will create value for all our shareholders."

Dr Olivier Brandicourt, healthcare expert to Odyssey, said: "BenevolentAI, leveraging its Knowledge Graph technology, is very well positioned to unlock a new phase of growth in the pharmaceutical R&D industry. BenevolentAI has already produced substantial evidence of the potency and efficiency of its platform, notably through the quality of its existing pipeline of candidates and its strong and expanding collaboration with AstraZeneca. We are confident in the ability of BenevolentAI to sustainably generate a pipeline of first- and best-in-class programmes and to become a key player in the global drug discovery sector."

TRANSACTION HIGHLIGHTS

The combination of Odyssey, a €300m Euronext Amsterdam-listed special-purpose acquisition company focused on European healthcare and TMT growth companies, and BenevolentAI, a leading clinical-stage AI drug discovery company, represents the largest European SPAC merger announced to date and one of the largest Euronext Amsterdam biotech listings ever.

Founded in 2013, BenevolentAI has built a proprietary AI-based drug discovery platform that, combined with the scientific expertise of approximately 300 world-class scientists and technologists and full wet-lab capabilities, enables the delivery of novel drug candidates with a higher probability of clinical success than those developed using traditional methods. BenevolentAI has a consistently proven track-record of scientifically validated discoveries.

AI-driven drug discovery is at an inflection point and represents a significant growth opportunity.

AI-led drug discovery is becoming a powerful tool to accelerate biomedical innovations and discoveries, with the potential to achieve materially higher clinical success rates and drive efficiencies across the drug discovery process through the use of data-driven insights and analysis.

The sector is now at an inflection point and is increasingly becoming a strategic focus area for pharma companies, attracting significant capital and investment.

BenevolentAI is a leader in AI-enabled drug discovery with a highly promising pipeline.

BenevolentAI is a recognised industry leader in AI-enabled drug discovery; its existing pipeline alone could potentially address a patient base of over 260 million people with a current market opportunity above $30 billion.

Through the combined capabilities of its leading Knowledge Graph, AI-enabled BenevolentAI Platform and wet-lab facilities, BenevolentAI is well-positioned to not only identify new drug targets for complex and intractable diseases, with higher success rates than traditional drug discovery methods, but also to develop these targets at pace while generating experimental data at scale to fuel continuous innovation.

BenevolentAI has a proven scientific and commercial track-record.

All of BenevolentAI’s 20+ in-house drug programmes are platform-generated, discovered and developed using the company’s AI and machine learning tools. This includes a novel target for treating ulcerative colitis and an atopic dermatitis programme in the clinic. BenevolentAI’s multi-target commercial collaboration with AstraZeneca delivered the first novel AI-generated target for chronic kidney disease into AstraZeneca’s portfolio, and this collaboration is now being expanded. BenevolentAI also successfully identified Eli Lilly’s baricitinib as a treatment for COVID-19, which is now FDA emergency-use approved.

BenevolentAI has a highly versatile and diversified business model.

BenevolentAI is highly versatile and diversified, combining work across multiple therapeutic areas with the ability to develop pre-clinical and early-stage clinical assets in-house, to out-license or to collaborate with partners on new drug discovery and development.

BenevolentAI has an experienced management team supported by industry-leading Board members and scientific advisors.

BenevolentAI is led by an experienced management team with an outstanding track record in healthcare and technology, supported by industry-leading Board members and scientific advisors.

Highly attractive value proposition with significant and tangible upside.

Odyssey believes the investment opportunity represents an attractive value proposition with significant upside, as evidenced by the extensive pipeline of drug candidates and the potential of the BenevolentAI Platform.

TRANSACTION OVERVIEW

Odyssey has agreed to combine with BenevolentAI at a pre-money valuation of €1.1 billion and a post-money valuation of up to €1.5 billion, prior to any redemptions. The combination will be effected by way of a share exchange. BenevolentAI shareholders will receive Class A ordinary shares (the "Ordinary Shares") of Odyssey in exchange for their shares of BenevolentAI. Their BenevolentAI options and RSUs will convert into options and RSUs of Odyssey. As a result of the share exchange, BenevolentAI will become a wholly-owned subsidiary of Odyssey, which, following the closing of the transaction, will change its name to BenevolentAI. BenevolentAI is expected to benefit from a strong cash position, including €135m fully-committed PIPE, €300m of gross cash held in escrow by Odyssey (prior to any redemptions) and an estimated €56m of cash on BenevolentAI’s balance sheet as at 30 November 2021. Assuming that no Odyssey shareholders elect to redeem their Ordinary Shares in connection with the transaction, current BenevolentAI shareholders are expected to own 67.4% of the combined company (including vesting RSUs and options), Odyssey shareholders (including the Sponsor) 23.5%, and PIPE investors 9.1% of the post-transaction pro-forma equity, respectively. None of the current shareholders of BenevolentAI will sell stock as part of the transaction, and BenevolentAI’s core shareholders and current members of the board of directors of BenevolentAI, representing collectively approximately 86% of the current capital of BenevolentAI, will be subject to a lock-up of 180 days, subject to limited market standard exceptions.

The Board of Directors of Odyssey and the Board of Directors of BenevolentAI have each unanimously approved the proposed transaction. The closing of the transaction is subject to the satisfaction or waiver of customary closing conditions, including the approval by a general meeting of Odyssey’s shareholders and a minimum cash balance at closing (see "Conditions to Closing" below), and is expected to close in Q1 2022. Following the closing of the transaction, the combined company will be listed on Euronext Amsterdam and will trade under the ticker symbol "BAI". The combined company will be led by the current CEO of BenevolentAI, Joanna Shields, alongside BenevolentAI’s industry-leading management and research team. Olivier Brandicourt, healthcare expert to Odyssey, will join the combined company’s Board of Directors alongside Jean Raby, Odyssey’s current co-CEO. Dr Francois Nader, current Chairman of the Board of Directors of BenevolentAI, will assume the role of Chairman of the Board of Directors of the combined company. The combined company will be headquartered in London.

INVESTOR PRESENTATION

Odyssey and BenevolentAI will host an investor conference call today at 14:00 CET via webcast to discuss the proposed transaction. The webcast is accessible as an audio only livestream via BenevolentAI’s website (www.benevolent.com/investors), alternatively investors can join via phone to listen to the webcast and participate in a Q&A with management.

Further information about the transaction is available on BenevolentAI’s website (www.benevolent.com) and on the Odyssey website (www.odyssey-acquisition.com).

ADVISORS

Goldman Sachs International is serving as exclusive financial advisor to BenevolentAI in connection with the business combination. Goldman Sachs International is also acting as placement agent on the PIPE. Latham & Watkins (London) LLP, NautaDutilh Avocats Luxembourg S.a r.l. and NautaDutilh N.V. are serving as legal advisors to BenevolentAI.

J.P. Morgan AG and Zaoui & Co are serving as financial advisors to Odyssey. J.P. Morgan AG is also acting as placement agent on the PIPE. Skadden, Arps, Slate, Meagher & Flom (UK) LLP, ELVINGER HOSS PRUSSEN, société anonyme and Stibbe N.V. are serving as legal advisors to Odyssey.

Odyssey was supported in its due diligence by Oliver Wyman (commercial advisors), Accuracy (accounting advisors), Arsène-Taxand (tax advisors) and former DeepMind Health Research Lead Trevor Back (AI expert).

Linklaters LLP is serving as legal advisor to the placement agents on the PIPE.

[1]Prior to any redemptions, excluding €56m of cash on BenevolentAI’s balance sheet estimated as at 30 November 2021 and including transaction expenses.

On December 6, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC), a clinical-stage biotechnology company, reported that the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), and the Alliance for Clinical Trials in Oncology, have completed enrollment of 267 patients in the Phase 2 portion of the adaptive Phase 2/3 trial evaluating whether uproleselan improves overall survival in newly diagnosed patients 60 years or older with acute myeloid leukemia (AML) (Press release, GlycoMimetics, DEC 6, 2021, View Source [SID1234596480]). The randomized, controlled trial is evaluating the addition of uproleselan, GlycoMimetics’ investigational, first-in-class, targeted antagonist of E-selectin, to a standard cytarabine/daunorubicin regimen (7&3) in older adults with previously untreated AML who are suitable for intensive chemotherapy. Completion of enrollment now sets the stage for a planned evaluation of the Phase 2 portion of the trial to determine whether the prespecified threshold for continuing to Phase 3 has been met based on event-free survival (EFS). Geoffrey Uy, M.D., Professor of Medicine, Washington University School of Medicine in St. Louis, is the trial’s Principal Investigator. GlycoMimetics and NCI are collaborating on the development of uproleselan under a Cooperative Research and Development Agreement.

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This press release features multimedia. View the full release here: View Source

"I would like to thank the Alliance for completing the enrollment of the Phase 2 portion despite all of the logistical challenges associated with the pandemic. If the EFS analysis meets the preplanned metric, the data will be transferred confidentially to GlycoMimetics to support regulatory filings for uproleselan in AML, and enrollment will continue in the Phase 3 portion of the trial," said Harout Semerjian, GlycoMimetics Chief Executive Officer. "Together, the GlycoMimetics- and NCI-sponsored programs will constitute a large dataset of 650 patients with AML. We would anticipate filing with regulatory agencies for approval for treatment of patients in both the frontline and relapsed/refractory AML settings should both trials achieve positive readouts."

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted antagonist of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy designation from the U.S. Food and Drug Administration and the Chinese Health authority for the treatment of adult patients with AML who have relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance.

On December 6, 2021 IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer therapies based on its T-win technology platform, reported that it has entered into a third clinical trial collaboration and supply agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada), through a subsidiary (Press release, IO Biotech, DEC 6, 2021, View Source [SID1234596479]). The purpose of the collaboration is to evaluate IO Biotech’s lead candidate, IO102-IO103, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in previously untreated patients with three different tumor types— metastatic non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), and metastatic urothelial bladder cancer (UBC). IO102-IO103 is an investigational novel immunotherapeutic agent designed to target the mechanisms mediated by key immunosuppressive proteins such as Indoleamine 2,3-dehydrogenase (IDO) and PD-L1.

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"We are pleased to be collaborating once again with Merck to study the potential of our IDO and PD-L1 derived immune-modulating therapy in combination with pembrolizumab as part of our broad, late-stage development program," said Mai-Britt Zocca, PhD, CEO and founder of IO Biotech. "We believe IO102-IO103 has the potential to show utility for multiple cancer indications, and we look forward to expanding our dataset in these additional settings."

The planned Phase 2 trial will evaluate the safety and efficacy of the combination of IO102-IO103 with pembrolizumab in patients with previously untreated metastatic NSCLC, SCCHN, or UBC. Additional correlative endpoints will also be explored to elucidate the mechanism of action. Under the terms of the agreement, IO Biotech will sponsor the Phase 2 trial and Merck will supply pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

About IO102-IO103/IOB-022

Based on the results from a Phase 1/2 clinical trial, IO102-IO103, in combination with pembrolizumab, was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for treatment of unresectable/metastatic melanoma. IO Biotech plans to initiate a Phase 3 combination trial of IO102-IO103 and KEYTRUDA (pembrolizumab), as first-line treatment in metastatic melanoma patients which is designed to be potentially registrational for IO102-IO103.

On December 6, 2021 Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, reported the presentation of interim clinical data from the company’s ongoing Phase 1/2 study of BDC-1001, the company’s lead immune-stimulating antibody conjugate (ISAC) in a poster session at the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) Congress 2021, being held virtually from Dec. 6-11, 2021 (Press release, Bolt Biotherapeutics, DEC 6, 2021, View Source [SID1234596478]). The lead author for the poster is Manish Sharma, M.D., START Midwest, with contributions from Ecaterina Dumbrava, M.D., MD Anderson Cancer Center, and other colleagues from the U.S. and South Korea.

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The company reported data from 57 subjects participating in an ongoing Phase 1/2 study of BDC-1001, across 16 different types of HER2-expressing solid tumors. BDC-1001 demonstrated a favorable safety and tolerability profile at all evaluated doses and schedules, showing early signs of clinical activity with corresponding biomarker changes in the tumor microenvironment of post-treatment tumor biopsies. BDC-1001 is an immune-stimulating antibody conjugate (ISAC) comprising a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to an innovative TLR7/8 agonist.

"The favorable safety profile and early indications of clinical disease control in the BDC-1001 study are encouraging," said Dr. Sharma, Associate Director of Clinical Research at START Midwest. "There is a clear need for well tolerated, durable treatments in the fight against cancer and I’m excited to see if BDC-1001 can deliver on that potential as we explore higher drug exposure levels."

The poster presentation at ESMO (Free ESMO Whitepaper) I-O reported new safety, pharmacokinetic/pharmacodynamic, and efficacy results for the ongoing Phase 1 dose-escalation portion of the BDC-1001 monotherapy trial. Fifty-seven subjects have been treated at increasing dose levels up to 20 mg/kg every three weeks and 12 mg/kg every two weeks, and data from these subjects demonstrate that:

BDC-1001 continues to have a favorable safety and tolerability profile with mild (grade 1/grade 2) infusion related reactions in some patients and no dose-limiting toxicities at dose levels up to 20 mg/kg every three weeks and 12 mg/kg every two weeks. There was no indication of cytokine release syndrome (CRS), and a maximum tolerated dose (MTD) has not been reached.

Early signs of clinical activity are noted in 13 of 40 tumor evaluable subjects with one durable partial response maintained through 52 weeks and multiple subjects achieving stable disease for >12 weeks.

The pharmacokinetic (PK) data demonstrate increasing peak drug levels with increasing dose, and linearity of PK above the 5 mg/kg dose level. Clinical PK modeling predicts that target exposure levels can be achieved with weekly dosing.

Plasma and tissue biomarker results show increase in multiple biomarkers indicative of myeloid cell and TLR 7/8 activation that is consistent with BDC-1001’s mechanism of action. Increasing drug exposure correlates with increases in plasma cytokines and corresponding biomarker changes in the tumor microenvironment of multiple post-treatment tumor biopsies, with intriguing signs of clinical disease control.

These encouraging data point to the need for increased drug exposure to optimize clinical benefit. The favorable safety profile of BDC-1001 allows for continued enrollment in the dose escalation portion of the study, and the Company’s refined PK model based on data from more than 50 patients predicts that weekly administration will provide BDC-1001 exposures at or above the target exposure threshold. The data also support initiation of the combination therapy study with nivolumab (PD-1 inhibitor).

"Bolt Biotherapeutics is committed to agile clinical development based on data. In this Phase 1/2 study of BDC-1001, we have gained tremendous insight into the ability of this novel candidate to mobilize the patient’s immune system in targeting the tumor and its microenvironment. The increases in myeloid cell infiltration and repolarization of macrophages we’ve seen in multiple post-treatment biopsies are provocative and consistent with our proposed mechanism of action," said Edith Perez, M.D., Chief Medical Officer of Bolt Biotherapeutics. "We look forward to exploring weekly dosing as we get closer to determining the recommended Phase 2 dose for BDC-1001 as monotherapy, and to initiating combination therapy with a checkpoint inhibitor."

Presentation Details

Title: Preliminary results from a phase 1/2 study of BDC-1001, a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), in patients (pts) with advanced HER2-expressing solid tumors

Lead author: Manish R. Sharma, M.D.

Presentation Number: 164P

Timing: On-demand access beginning Dec. 6 at 12:00 p.m. CET.

The poster presentation will be available on the ESMO (Free ESMO Whitepaper) I-O conference website and on Bolt’s website.

Conference Call and Webcast Details

Bolt Biotherapeutics management will host a conference call for the investment community, in conjunction with the now virtual ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2021, to discuss emerging clinical data and insights from the ongoing Phase 1/2 study today, Monday, December 6, 2021, at 8:00 a.m. ET/5 a.m. PT.

The conference call can be accessed by dialing +1 (833) 665-0609 within the U.S. or Canada or by dialing +1 (929) 517-0400 from international locations. The passcode for the call is 2633068. A live webcast, including slides, will be available on the Events & Presentations page of Bolt Biotherapeutic’s website at www.boltbio.com. An archived replay can be accessed for 30 days following the webcast.

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform

ISACs are a new category of immunotherapy that combines the precision of antibody targeting with the strength of the innate and adaptive immune systems. Boltbody ISACs comprise three primary components: a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant to activate the patient’s innate immune system. By initially targeting a single marker on the surface of a patient’s tumor cells, an ISAC can create a new immune response by activating and recruiting myeloid cells. The activated myeloid cells start a feed-forward loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This reprograms the tumor microenvironment and invokes an adaptive immune response that targets the tumor, with the goal of durable responses for patients with cancer.

On December 6, 2021 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), a clinical-stage biotechnology company developing eganelisib, a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic that selectively inhibits phosphoinositide-3-kinase gamma (PI3K-gamma), reported that it will host an investor event on updated data from the ongoing MARIO-3 clinical study during the San Antonio Breast Cancer Symposium (SABCS 2021) on Friday, December 10th at 9:30 am ET (Press release, Infinity Pharmaceuticals, DEC 6, 2021, View Source [SID1234596477]).

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The webinar will feature a presentation from Key Opinion Leader (KOL) Hatem Soliman, MD, MARIO-3 Investigator and Medical Director, Clinical Trials Office at the Moffitt Cancer Center.

Dr Soliman will discuss the evolving treatment landscape in TNBC and the significant unmet medical need that remains for patients with frontline, metastatic TNBC.
Importantly, Dr Soliman will review the MARIO-3 study design and summarize patient demographics and baseline characteristics as well as the updated safety and efficacy data from the MARIO-3 study.
Infinity’s Chief Medical Officer, Dr. Robert Ilaria, will review of eganelisib’s mechanism of action and translational data from the MARIO-3 study.

A Q&A session will follow the formal presentations. To register for the webinar please click here.

Hatem Soliman, MD is one of the leading breast cancer physicians in the country and an investigator on the MARIO-3 study. Dr. Soliman serves as the Medical Director of the Clinical Trials Office at the Moffitt Cancer Center, with extensive experience as a clinical investigator conducting both translational research in breast cancer immunotherapy and leading numerous clinical trials as principal investigator since joining the faculty at Moffitt in 2008. He also serves as the Course Director for the fellowship clinical research rotation, medical director of the phase 1 program, chair of Moffitt’s clinical research leadership council, chair of clinical research feasibility committee, and principal investigator for Moffitt’s CPDM CCSG application, which was recently rated as outstanding and awarded funding for an additional five years.

Dr. Soliman received his BS in Genetics from the University of Georgia Athens in 1996 and then went on to receive his medical degree from the Medical College of Georgia in 2002. His residency and fellowship training in oncology/hematology was completed through the University of South Florida/Moffitt Cancer Center program in 2008. During fellowship, he authored investigator initiated early phase trials with mentorship from Dr. Daniel Sullivan, former ACD and EVP of Moffitt, in collaboration with the NCI CTEP RAID program investigators Drs. Jaime Zwiebel and Howard Streicher. Upon graduation, Dr. Soliman was offered an assistant member position at Moffitt as a clinical investigator to continue early drug development and translational research activities.