On October 7, 2021 The Board of Directors of Alligator Bioscience AB (publ) ("Alligator" or "the Company") reported that , subject to approval by the Extraordinary General Meeting on 8 November 2021, resolved to carry out a rights issue of shares with preferential rights for the Company’s existing shareholders of approximately SEK 257 million (the "Rights Issue") (Press release, Alligator Bioscience, OCT 7, 2021, View Source [SID1234590892]). The Company has received subscription commitments from a selection of the Company’s larger existing shareholders, including the AP4, Roxette Photo NV and Omentum S.A., amounting to approximately SEK 43 million, corresponding to approximately 17 percent of the Rights Issue. Furthermore, the Company has entered into agreements on guarantee commitments of approximately SEK 214 million, which secures the Rights Issue up to 100 percent. In addition, Öhman Fonder and all members of the Company’s board and management with shareholdings in the Company have expressed their intention to subscribe for their respective pro rata share in the Rights Issue. Alligator will use the proceeds from the Rights Issue to conduct phase II studies for mitazalimab, preparations for and initiation of phase II studies for ATOR-1017 and further development of other pipeline candidates. The Rights Issue is subject to approval by the Extraordinary General Meeting on 8 November 2021, and the notice of the Extraordinary General Meeting will be announced in a separate press release.
Summary

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One (1) existing share in the Company entitles to three (3) subscription rights. Two (2) subscription rights entitle to subscription of one (1) new share, i.e., a subscription ratio of 3:2.
The subscription price is SEK 2 per new share, which, assuming the Rights Issue is fully subscribed, results in the Company receiving issue proceeds of approximately SEK 257 million before deduction of transaction costs.
The record date for the Rights Issue is 10 November 2021 and the subscription period runs from and including 12 November 2021 up to and including 26 November 2021.
The last day of trading in the Alligator share including the right to participate in the Rights Issue is 8 November 2021.
The board’s resolution on the Rights Issue is subject to approval by the Extraordinary General Meeting on 8 November 2021. Major shareholders, who together represent approximately 17 percent of the shares and votes in the Company, have undertaken to vote for the Rights Issue at the Extraordinary General Meeting.
Major shareholders have expressed their support for the Rights Issue through subscription commitments amounting to approximately SEK 43 million, corresponding to approximately 17 percent of the Rights Issue. Furthermore, the Company has entered into agreements on guarantee commitments of approximately SEK 214 million, corresponding to approximately 83 percent of the Rights Issue, which secures the Rights Issue up to 100 percent. The guarantee commitments consist partly of a so-called top guarantee and partly of a bottom guarantee. In addition, Öhman Fonder and all members of the Company’s board and management have expressed their intention to subscribe for their respective pro rata share in the Rights Issue.
The Company intends to publish a prospectus regarding the Rights Issue on 9 November 2021.

Background and reason for the Rights Issue

Alligator is active in the phases of drug development that range from idea and early research to clinical phase II studies in patients. This includes, among other things, the development and optimization of new drug candidates, evaluation of preclinical efficacy and safety, and finally confirmatory clinical studies on cancer patients.

Alligator has shown strong Proof of Mechanism data in Phase I studies for mitazalimab, Alligator’s most advanced immuno-oncology candidate. In 2021, the Company’s focus has been on preparations for the inclusion of the first patient in the clinical phase II study OPTIMIZE-1. The first patient was successfully included in September 2021 and interim efficacy data are estimated for the end of the fourth quarter of 2022. In order to balance the risk in the Company’s development portfolio and to increase the likelihood of clinical success, Alligator is planning a second phase II study with mitazalimab, OPTIMIZE-2. In the study, mitazalimab is planned to be combined with current standard of care in renal cell carcinoma, bladder cancer or hepatocellular carcinoma. OPTIMIZE-2 is expected to start in the second half of 2022.

In June 2021, new promising data from the Phase I study with ATOR-1017 were presented, confirming the therapeutic potential and demonstrating clear signals of proof of mechanism in combination with a favorable safety profile. Previous interim data, presented in the fall of 2020, from the ongoing Phase I study in patients with advanced cancer showed a promising safety profile for ATOR-1017, with only a few drug-related side effects all being mild or moderate (grade 1 or 2). Preparations are ongoing to start clinical Phase II studies, which is expected to take place during the third quarter of 2022.

To ensure continued successful development in accordance with the Company’s business plan and strategy, Alligator has resolved to carry out the Rights Issue. The Rights Issue is estimated to provide Alligator with approximately SEK 257 million before transaction costs. The board assesses that the working capital requirement for the coming twelve-month period is met by available cash and the net proceeds from the Rights Issue.

The expected net proceeds from the Rights Issue will, in the following order of priority and with an approximate proportion indicated in parentheses, be used for:

Conduction of phase II studies with mitazalimab (65 percent)
Preparations for and initiation of phase II study for ATOR-1017 (15 percent)
Development of other pipeline candidates (20 percent)

Terms of the Rights Issue

Those who are registered as shareholders on the record date, 10 November 2021, have the preferential right to subscribe for new shares in the Rights Issue in relation to the number of shares held on the record date. One (1) existing share in the Company entitles to three (3) subscription rights. Two (2) subscription rights entitle to subscription of one (1) new share, i.e., a subscription ratio of 3:2. In addition, investors are offered the possibility to subscribe for shares without subscription rights.

If not all newly issued shares are subscribed for by exercise of subscription rights, allotment of the remaining shares shall be made within the highest amount of the Rights Issue: firstly, to those who have subscribed for shares by exercise of subscription rights (regardless of whether they were shareholders on the record date or not) and who have applied for subscription of shares without exercise of subscription rights and if allotment to these cannot be made in full, allotment shall be made pro rata in relation to the number of subscription rights that each and every one of those, who have applied for subscription of shares without exercise of subscription rights, have exercised for subscription of shares; secondly, to those who have applied for subscription of shares without exercise of subscription rights and if allotment to these cannot be made in full, allotment shall be made pro rata in relation to the number of shares the subscriber in total has applied for subscription of shares; and thirdly, to those who have provided underwriting commitments with regard to subscription of shares, in proportion to such underwriting commitments. To the extent that allotment in any section above cannot be done pro rata, allotment shall be determined by drawing of lots.

The subscription price is SEK 2 per new share. Provided that the Rights Issue is fully subscribed, the share capital will increase by a maximum of SEK 51,399,802.80 by a new issue of a maximum of 128,499,507 new shares. In the event of full subscription, the Rights Issue will provide Alligator with approximately SEK 257 million before deduction of issue costs. Shareholders who choose not to participate in the Rights Issue will, provided that the Rights Issue is fully subscribed, have their ownership diluted by approximately 60 percent, but are able to financially compensate for this dilution by selling their subscription rights.

Subscription of shares shall take place during the period from and including 12 November 2021 to and including 26 November 2021. The board has the right to extend the subscription and payment period. A possible extension of the subscription period shall be announced by press release no later than the last subscription day in the Rights Issue, i.e. 26 November 2021. Trading in subscription rights takes place on Nasdaq Stockholm during the period from and including 12 November 2021 to and including 23 November 2021 and trading in paid subscribed shares (Sw. Betalda tecknade aktier) during the period from and including 12 November 2021 until the Rights Issue has been registered with the Swedish Companies Registration Office (Sw. Bolagsverket).

Subscription commitments, guarantee commitments and declarations of intent

Alligator has received subscription commitments from a selection of the Company’s larger existing shareholders, including the AP4, Roxette Photo NV and Omentum S.A., amounting to approximately SEK 43 million, corresponding to approximately 17 percent of the Rights Issue. Furthermore, the Company has entered into agreements on guarantee commitments in the form of a so-called bottom guarantee of approximately SEK 188 million, corresponding to approximately 73 percent of the Rights Issue, and a so-called top guarantee of approximately SEK 26 million, corresponding to approximately 10 percent of the Rights Issue. In addition, Öhman Fonder and all members of the Company’s board and management with shareholdings in the Company, including Søren Bregenholt (CEO), Anders Ekblom (Chairman of the board), Marie Svensson (CFO), Peter Ellmark (CSO), Veronica Wallin (board member) and Hans-Peter Ostler (board member), have expressed their intentions to subscribe for their respective pro rata share in the Rights Issue. The bottom guarantee ensures, provided that subscription corresponds to at least the subscription commitments, that approximately 90 percent of the Rights Issue is subscribed and paid for. Through the top guarantee, provided that subscription corresponds to at least the subscription commitments and the bottom guarantee, that 100 percent of the Rights Issue is subscribed and paid for.

For the guarantee commitments, compensation is paid either in cash or in the form of newly issued shares in the Company. The subscription price for any shares issued to guarantors shall correspond to 90 percent of the volume-weighted average share price (VWAP) for the Company’s share on Nasdaq Stockholm during the subscription period in the Rights Issue (i.e. during the period 12 – 26 November 2021), however no lower than the subscription price in the Rights Issue. In order to enable new issues of shares as guarantee compensation to the guarantors who choose to receive guarantee compensation in newly issued shares, the board has proposed that the Extraordinary General Meeting on 8 November 2021, which is proposed to resolve on the approval of the Rights Issue, also resolves on authorization for the board to resolve on new issues of such shares to guarantors.[1]

Preliminary timeline for the Rights Issue

8 November 2021

Extraordinary General Meeting

8 November 2021

Last day of trading incl. preferential rights

9 November 2021

First day of trading excl. preferential rights

9 November 2021

Estimated publication of prospectus

10 November 2021

Record date

12 November – 23 November 2021

Trading in subscription rights

12 November – 26 November 2021

Subscription period

12 November 2021 – Until the Rights Issue is registered at the Swedish Companies Registration Office

Trading in paid subscription shares (Sw. "BTA")

1 December 2021

Estimated publication of outcome in the Rights Issue

Lock-up agreements

In connection with the Rights Issue, the Company has undertaken towards the Joint Global Coordinators, subject to customary exceptions, not to issue additional shares or other share-related instruments for a period of 180 days after the end of the subscription period in the event of an issue with preferential rights for existing shareholders, and 90 days after the end of the subscription period in the event of an issue without preferential rights for existing shareholders. In addition, the Company’s board members and senior executives who own shares in Alligator, subject to customary exceptions, have undertaken, towards the Joint Global Coordinators, not to transfer or otherwise sell their shares for a period of 180 days after the end of the subscription period.

Extraordinary General Meeting

The board’s resolution on the Rights Issue is subject to approval by the Extraordinary General Meeting on 8 November 2021. Notice of the Extraordinary General Meeting will be announced in a separate press release.

Prospectus

Full terms and conditions for the Rights Issue, as well as other information about the Company and information about subscription commitments, guarantee commitments and lock-up commitments will be presented in the prospectus that the Company is expected to publish around 9 November 2021 (the "Prospectus").

Advisers

DNB Markets, a part of DNB Bank ASA, Sweden Branch and Redeye AB act as Joint Global Coordinators in connection with the Rights Issue. Setterwalls Advokatbyrå AB acts as legal adviser to Alligator and Baker & McKenzie Advokatbyrå KB acts as legal adviser to the Joint Global Coordinators in connection with the Rights Issue. Aktieinvest FK AB acts as the issuing agent in the Rights Issue.

On October 7, 2021 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported two poster presentations with new preclinical data for CA-4948, a first-in-class small molecule IRAK4 inhibitor, at the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual Conference on Molecular Targets and Cancer Therapeutics (Press release, Curis, OCT 7, 2021, View Source [SID1234590924]).

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"In ongoing Phase 1 clinical trials, CA-4948 has already demonstrated anti-tumor activity in non-Hodgkin’s lymphoma, acute myeloid leukemia and myelodysplastic syndromes. New preclinical data presented at AACR (Free AACR Whitepaper)-NCI-EORTC today support the potential of CA-4948 in additional hematologic cancers," said James Dentzer, President and Chief Executive Officer of Curis.

"Notably, these new preclinical data indicate that CA-4948 is synergistic with small molecules targeting BCR signaling, including both idelalisib and ibrutinib, and suggest it may help overcome or reduce secondary resistance to these therapies in marginal zone lymphoma. In addition, these data demonstrate that CA-4948 can cross the blood brain barrier and improve survival, in a dose-dependent manner, providing additional preclinical support for the study of CA-4948 in patients with primary central nervous system (pCNS) lymphoma, one of the most aggressive forms of lymphoma and a clear area of unmet need for patients." Mr. Dentzer added.

Details of the presentations are as follows:

Title: Pharmacological inhibition of IRAK-4 with CA-4948 is beneficial in marginal zone lymphoma models with secondary resistance to PI3K and BTK inhibitors
Author: Francesca Guidetti, Institute of Oncology Research, Faculty of Biomedical Sciences, USI, Bellinzona, Switzerland
Poster Number: P073

Title: The IRAK4 inhibitor CA-4948 demonstrates antitumor activity in a preclinical model of CNS lymphoma
Author: Christina A. von Roemeling, Ph.D., Research Associate, UF Brain Tumor Immunotherapy Program, Department of Neurosurgery, McKnight Brain Institute, University of Florida
Poster Number: P243
Additional meeting information can be found on the AACR (Free AACR Whitepaper) website at:
View Source

The presentations will also be available under "Posters and Presentations" in the Pipeline: CA-4948 section of the Company’s website at www.curis.com

About CA-4948

CA-4948 is an IRAK4 kinase inhibitor and IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, which are frequently dysregulated in patients with AML and MDS. Third parties have recently discovered that the long form of IRAK4 (IRAK4-L) is oncogenic and preferentially expressed in over half of patients with AML and MDS. The overexpression of IRAK4-L is believed to be driven by a variety of factors, including specific spliceosome mutations such as SF3B1 and U2AF1.

On October 7, 2021 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that XMT-2056, its first Immunosynthen STING-agonist ADC candidate, targets a novel epitope of human epidermal growth factor receptor 2 (HER2) and presented new preclinical data during a plenary session at the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) (Triple Meeting) (Press release, Mersana Therapeutics, OCT 7, 2021, View Source [SID1234590939]).

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"Previously, across multiple targets and models, we demonstrated that our Immunosynthen ADCs can stimulate the innate immune system in a targeted manner in both tumor cells and tumor-resident myeloid cells – a "one-two punch" resulting in robust efficacy. New head-to-head preclinical data comparing XMT-2056 to TLR7/8-agonist ADC and systemically-administered STING agonist benchmarks further supports the potential advantages of XMT-2056 to offer greater efficacy and a wider therapeutic index," said Timothy B. Lowinger, PhD, Chief Science and Technology Officer of Mersana Therapeutics. "In addition, new data with XMT-2056 in combination with trastuzumab supports our rationale for selecting an antibody that recognizes a novel epitope of HER2, providing broad combination potential with approved and investigational HER2 therapies."

"STING is a fundamental mechanism yet approaches to date have been unsuccessful at stimulating the innate immune system in a targeted manner. Our Immunosynthen platform not only has the potential to address this limitation but also is designed to allow us to extend our ADC development efforts beyond cytotoxic payloads, which we believe represents a significant advancement in the ADC field," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "We are particularly excited about the potential of XMT-2056 to offer a novel approach to the treatment of HER2-expressing tumors both as a single agent and in combination."

Previously reported preclinical data suggest that XMT-2056 offers a highly differentiated approach, enabling tumor-targeted delivery of a STING agonist with improved efficacy and tolerability over a systemically-administered STING agonist benchmark. In vitro and in vivo studies demonstrate that STING-agonist ADCs activate the STING pathway in both tumor-resident immune cells and tumor cells, offering the potential for an increased therapeutic index and an advantage over other innate immune activating pathways.

The Company has evaluated Immunosynthen ADCs across a wide range of antibodies, targets, tumor models and mouse strains and observed broad efficacy and consistent results demonstrating target-dependent anti-tumor effects and has selected HER2 as the first target for clinical evaluation with XMT-2056. The Company developed a differentiated anti-HER2 antibody that binds a novel epitope distinct from that of trastuzumab and pertuzumab, providing the opportunity for combinations with these well-established anti-HER2 therapies.

New preclinical data presented today at the Triple Meeting include:

XMT-2056 demonstrated increased efficacy in both high and low HER2 SCID mouse models in comparison to benchmark agents such as a trastuzumab-TLR7/8 agonist ADC as well as a small molecule systemically-administered STING agonist.
XMT-2056 showed excellent in vivo efficacy as a single agent in a SKOV3 HER2 high model and this efficacy is further enhanced by combining XMT-2056 with a 3 mg/kg dose of trastuzumab.
XMT-2056 was generally well-tolerated in NHP studies with no clinical signs and no adverse findings in clinical pathology or histopathology after single and repeat IV doses of 9 mg/kg, at exposures far exceeding those necessary for efficacy in mouse models, indicating the potential for a wide therapeutic index.

On October 7, 2021 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported the presentation of preclinical data characterizing the mechanism of action of EPI-7386, ESSA’s lead product candidate for the treatment of prostate cancer (Press release, ESSA, OCT 7, 2021, View Source [SID1234590962]). The data include the results of nuclear magnetic resonance (NMR) studies which confirm the binding of the compound to the N-terminal domain (NTD) of the androgen receptor (AR), a region not currently targeted by other antiandrogen therapies. Data were presented in a virtual video poster format at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper), National Cancer Institute (NCI), and European Organisation for Research and Treatment of Cancer (EORTC) Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), taking place virtually from October 7-10, 2021.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The virtual poster presentation, titled, "Comprehensive preclinical characterization of the mechanism of action of EPI-7386, an androgen receptor N-terminal domain inhibitor," will be presented and available for viewing starting October 7, 2021 at 9:00 a.m. ET.

The preclinical data confirm EPI-7386’s target engagement with the NTD of the AR through multiple studies:

Three separate orthogonal NMR approaches confirm that EPI-7386 binds to the Tau5 region of the NTD
Cellular thermal shift assays (CETSA) confirm engagement of EPI-7386 with both full length AR (AR-FL) and AR-V567es, a splice variant lacking the ligand-binding domain (LBD)
Gene expression driven by the AR splice variant, AR-V567es, can be inhibited by EPI-7386 whereas enzalutamide and darolutamide, which bind to the LBD, cannot inhibit AR-V567es-driven gene expression
Chromatin immunoprecipitation sequencing (ChIP-Seq) data indicate that EPI-7386 inhibits androgen-induced changes at the AR cistrome and when combined with enzalutamide, can completely abrogate genome-wide androgen-induced AR binding
"We are excited by the data presented today, which support ESSA’s novel approach to prostate cancer by definitively demonstrating that EPI-7386 binds to the N-terminal domain of the androgen receptor—the primary driver of prostate cancer growth," said Dr. David R. Parkinson, M.D., President and Chief Executive Officer of ESSA Pharma Inc. "Through this unique mechanism of AR inhibition, EPI-7386 can inhibit AR-driven biology in both full length and splice variant-driven prostate cancer models. Additionally, the data demonstrate that the combination of EPI-7386 with enzalutamide results in complete inhibition of genome-wide androgen-induced AR binding, supporting the rationale for our upcoming Phase 1/2 combination trials of EPI-7386 with approved antiandrogens in patients with metastatic castration-resistant prostate cancer."

The poster is available on the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC Virtual International Conference website and on the "Events & Presentations" section of the Company’s website at www.essapharma.com.

On October 7, 2021 Amgen (NASDAQ: AMGN) and Neumora Therapeutics, Inc. (Neumora), a clinical-stage biopharmaceutical company pioneering precision medicines for brain diseases, reported a strategic collaboration to advance neuroscience discovery, development and commercialization (Press release, Amgen, OCT 7, 2021, View Source [SID1234590983]). The companies will collaborate on programs by applying Neumora’s proprietary precision neuroscience platform to insights generated by Amgen’s deCODE genetics and human data research capabilities. In addition, Neumora has received a $100 million equity investment from Amgen and acquired exclusive global rights to develop and commercialize Amgen programs targeting casein kinase 1 delta and glucocerebrosidase for neurodegenerative diseases.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Neumora leverages proprietary multimodal capabilities and technologies to integrate advanced computational data science with R&D to increase the probability of success of drug development in brain diseases. Neumora’s precision neuroscience platform focuses on the creation of Data Biopsy Signatures to deconvolve the complex systems that drive brain diseases and connect the signatures to clinically meaningful measures to inform the development of therapeutics for an enriched patient population, or Precision Phenotypes.

Amgen’s deCODE genetics subsidiary is a global leader in analyzing and understanding human health and disease and has been at the forefront of the analysis of human data to enhance drug discovery and development. By leveraging these platform technologies and the complementary capabilities of both companies, the collaboration aims to discover unique and unprecedented insights into brain diseases across neuropsychiatric and neurodegenerative diseases, including schizophrenia and amyotrophic lateral sclerosis (ALS), ultimately leading to effective therapeutics targeted at patients most likely to respond to treatment.

"Our collaboration with Neumora leverages both our unique capabilities from deCODE and Neumora’s focus and expertise in brain diseases to discover and develop potentially best-in-class precision therapies," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Although Amgen is not currently engaged in neuroscience research and early development internally, this approach addresses our commitment to remain engaged in neuroscience through external collaborations, and we are excited to work with Neumora to propel R&D for brain diseases into the future and advance promising new medicines."

"This partnership with Amgen underscores the vast potential of precision drug development for brain diseases; insights generated by deCODE will further enhance Neumora’s data-driven precision medicine approach," said Paul L. Berns, co-founder, chairman and chief executive officer at Neumora. "We are also excited to expand our pipeline with potential best-in-class programs targeting casein kinase 1 delta and glucocerebrosidase for neurodegenerative diseases. Neumora is poised to become a pioneer in precision drug development for brain diseases and we look forward to working with Amgen to advance promising new medicines for patients in need of better treatment options."

About deCODE Genetics
Based in Reykjavik, Iceland, deCODE is a global leader in analyzing and understanding the human genome. Using its unique expertise in human genetics combined with growing expertise in transcriptomics and population proteomics and vast amount of phenotypic data, deCODE has discovered risk factors for dozens of common diseases and provided key insights into their pathogenesis. The purpose of understanding the genetics of disease is to use that information to create new means of diagnosing, treating and preventing disease. deCODE is a wholly-owned subsidiary of Amgen.