On September 30, 2021 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that interim Phase I results from its Phase I/II trial of BT5528, a second-generation Bicycle Toxin Conjugate (BTC) targeting EphA2, has been selected for a plenary oral presentation at the upcoming 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), being held October 7-10, 2021 (Press release, Bicycle Therapeutics, SEP 30, 2021, View Source [SID1234590566]). The Company will host a conference call to discuss the results and provide an update on preliminary findings from the BT8009 program on Thursday, October 7, 2021 at 3:00 p.m. ET.

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AACR-NCI-EORTC Plenary Oral Presentation Details:
Title: A first in class phase I/II Study of the Novel Bicyclic Peptide and MMAE Conjugate, BT5528, in patients with Advanced Malignancies Associated with EphA2 Expression
Presenter: Meredith McKean, M.D., Sarah Cannon Research Institute at Tennessee Oncology
Session Title: Tumor-targeted Conjugates: A Growing Family
Date/Time: Thursday, October 7 at 12:50 p.m. ET

Conference Call Details
Bicycle Therapeutics will host a conference call and webcast on Thursday, October 7 at 3:00 p.m. ET to review the data being presented and provide an update on preliminary findings from the BT8009 program. To access the call, please dial (800) 377-9118 (domestic) or (409) 937-8920 (international) and provide the Conference ID 2287246. A live webcast of the presentation will be available on the Investors & Media section of the Bicycle website, bicycletherapeutics.com.

On September 30, 2021 Sunovion Pharmaceuticals Inc. (Sunovion),its parent company Sumitomo Dainippon Pharma Co., Ltd. (Sumitomo Dainippon Pharma) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) reported that the companies have entered into a worldwide license agreement for the joint development and commercialization of four compounds: ulotaront (SEP-363856), non-racemic ratio of amisulpride enantiomers (SEP-4199), SEP-378614 and SEP-380135 (Press release, Sunovion, SEP 30, 2021, View Source [SID1234590587]).

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Leveraging their complementary therapeutic area expertise and capabilities, the companies expect to fully explore the medical potential of the compounds in the collaboration, and accelerate development timelines, to bring forward important treatments for people living with neuropsychiatric health conditions worldwide. Otsuka’s subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc., will jointly lead, together with Sunovion, the effort to advance the research and development program worldwide, as well as plan for future commercial activities.

"Sunovion, with our parent company Sumitomo Dainippon Pharma, is proud to collaborate with Otsuka in a shared mission to contribute towards improved lives and better health globally," said Antony Loebel, M.D., President and Chief Executive Officer of Sunovion. "Otsuka’s recognition of the significant value of these assets reflects the innovative discovery and development efforts at Sunovion over the past decade, as well as our neuropsychiatry commercialization expertise and capabilities. We look forward to working with Otsuka colleagues as we advance novel compounds to treat patients with serious neuropsychiatric conditions."

"We are pleased to have signed this agreement with Otsuka, which has wide global reach and significant neuropsychiatry expertise. We will work together to more rapidly and reliably develop and commercialize valuable pharmaceuticals for patients around the world with the expectation that these new medications will grow," said Hiroshi Nomura, President and Chief Executive Officer of Sumitomo Dainippon Pharma. "Sumitomo Dainippon Pharma aims to achieve sustained growth through global collaboration in anticipation of future changes in the business environment. This collaboration is a major step forward in this initiative."

"Otsuka has been committed to providing new antipsychotics that contribute to patients worldwide in the field of neuropsychiatry by leveraging internal capabilities and external collaborations, starting with the launch of antipsychotics in the U.S. in 2002," said Makoto Inoue, President and Representative Director of Otsuka. "We are advancing in new areas such as the development of drugs to treat agitation associated with dementia of the Alzheimer’s type and the deployment of the world’s first digital medicine. Through this agreement, we are confident the companies will be able to deliver even more value to patients through the experience and networks that we have cultivated over many years worldwide."

This collaboration recognizes that there is a great need for novel treatments in the area of neuropsychiatric medicine development. The companies are focused on working together on solutions to address these areas of unmet medical need by advancing four promising compounds―ulotaront (SEP-363856), SEP-4199, SEP-378614 and SEP-380135―that address serious neuropsychiatric disorders. The goal of the co-development programs is to contribute to changing the course of serious medical conditions and provide new treatment options to patients and healthcare providers globally.

Upon the completion of the agreement, in addition to an upfront payment of USD 270 million, Sunovion is eligible for development milestone payments of up to USD 620 million for the four compounds and relevant sales milestone payments. Sunovion and Otsuka will share profits from the four compounds, as well as all expenses for clinical studies, applications for approval, and commercialization in each country. Additional details regarding terms of the agreement are not being disclosed.

About Sunovion Compounds

The four clinical-stage assets―ulotaront (SEP-363856), non-racemic ratio of amisulpride enantiomers (SEP-4199), SEP-378614 and SEP-380135―included within the collaboration span early- to late-stage development. The compounds represent a scientifically unique approach to treating symptoms that are not adequately addressed by current therapeutic options and/or for which existing treatments have an unsatisfactory safety and tolerability profile.

Ulotaront (SEP-363856), in Phase 3, is a trace amine-associated receptor 1 (TAAR1) agonist with 5-HT1A agonist activity that is under investigation for the treatment of schizophrenia with additional indications under consideration. Ulotaront was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia. Ulotaront is the first TAAR1 agonist to enter into Phase 3 clinical studies in adults and adolescents (13 to 17 years) with schizophrenia.

Non-racemic amisulpride (SEP-4199) is in Phase 3 clinical development for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression). Sunovion discovered that the pharmacology of amisulpride is enantiomer-specific and increasing the ratio of R-amisulpride to S-amisulpride increases the potency for serotonin 5-HT7 receptors relative to dopamine D2 receptors. SEP-4199 was designed with an 85:15 ratio of R-amisulpride to S-amisulpride to increase levels of serotonin 5-HT7 activity intended to enhance antidepressant efficacy and produce reduced levels of D2 receptor occupancy appropriate for the treatment of bipolar depression. In September 2021 Sunovion initiated a global clinical Phase 3 study, which is a randomized, double-blind, placebo-controlled, parallel-group, fixed-dosed study for the treatment of bipolar I depression in the U.S. Japan will join this global clinical Phase 3 study.

SEP-378614 and SEP-380135 are in Phase 1 development and can be viewed on the Sunovion pipeline here.

Sunovion discovered ulotaront, SEP-378614, and SEP-380135 in collaboration with PsychoGenics based in part on a mechanism-independent approach using the in vivo phenotypic SmartCube platform and associated artificial intelligence algorithms.

Sunovion has a robust portfolio of clinical and pre-clinical compounds, not included in this agreement, which the company continues to advance for some of the most prevalent, challenging, and underserved neuropsychiatric conditions.

About Neuropsychiatric Disorders

Neuropsychiatric disorders are among the most complex and difficult to treat. Disorders of the brain are often associated with significant and disabling effects on patients, impacting their loved ones and society more broadly. Nearly one in six people worldwide live with a neurological disorder,1 29 million people worldwide are living with bipolar disorder,2 and 20 million people worldwide are living with schizophrenia.3

On September 30, 2021 BridGene Biosciences, Inc., a biotechnology company using a unique chemoproteomic technology to discover and develop small molecules for high value, traditionally undruggable targets, reported the titles of the abstracts accepted by the American Association for Cancer Research (AACR) (Free AACR Whitepaper) for poster presentations during the 2021 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) (Press release, Bridgene Biosciences, SEP 30, 2021, View Source [SID1234590603]). BridGene submitted five abstracts detailing the company’s proprietary small molecule discovery platform, IMTAC (Isobaric Mass Tagged Affinity Characterization), BridGene’s latest discovery of therapeutic candidates, and the identification of new targets for approved small molecule drugs. The conference will take place virtually October 7–10, 2021.

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The titles of the abstracts are currently available on the AACR (Free AACR Whitepaper) web site, with full abstracts, including the dates and times of presentations, scheduled for publication at 9:00 a.m. ET on October 7, 2021. The titles of the presentations are as follows:

Abstract Title: A chemoproteomic platform for identifying small-molecule modulators of protein-protein interactions, discovering new cancer targets, and revealing previously unknown targets for well-known drugs
Authors:
Cindy Huang, Ph.D., Senior Research Scientist, BridGene Biosciences
Vivian Zhang, Ph.D., Research Scientist, BridGene Biosciences
Ning Deng, Ph.D., Senior Research Scientist, BridGene Biosciences
Irene Yuan, Executive Vice President, BridGene Biosciences
Linda Pullan, Ph.D., Head of Business Development, BridGene Biosciences
C. Glenn Begley, Ph.D., Head of Biology, BridGene Biosciences
Ping Cao, Ph.D., CEO, BridGene Biosciences

Abstract Title: Identification of previously unknown targets for approved small-molecule drugs using chemoproteomic platform IMTAC
Authors:
Vivian Zhang, Ph.D., Research Scientist, BridGene Biosciences
Cindy Huang, Ph.D., Senior Research Scientist, BridGene Biosciences
Chao Zhang, Ph.D., Associate Professor of Chemistry, University of Southern California
Ping Cao, Ph.D., CEO, BridGene Biosciences

Abstract Title: Discovery of novel small-molecule inhibitors for an epigenetic modulator WDR5
Authors:
Cindy Huang, Ph.D., Senior Research Scientist, BridGene Biosciences
Shirley Guo, Ph.D., Principal Scientist, BridGene Biosciences
Ping Cao, Ph.D., CEO, BridGene Biosciences

Abstract Title: Discovery and development of novel covalent inhibitors of the YAP-TEAD transcription activity
Authors:
Shirley Guo, Ph.D., Principal Scientist, BridGene Biosciences
Cindy Huang, Ph.D., Senior Research Scientist, BridGene Biosciences
C. Glenn Begley, Ph.D., Head of Biology, BridGene Biosciences
Michael J. Bishop, Ph.D., Head of Chemistry, BridGene Biosciences
Ping Cao, Ph.D., CEO, BridGene Biosciences

Abstract Title: Discovery of a covalent inhibitor for an oncogenic mutant RhoAY42C
Authors:
Shirley Guo, Ph.D., Principal Scientist, BridGene Biosciences
Ping Cao, Ph.D., CEO, BridGene Biosciences

"We are excited to have all five of our abstracts accepted for poster presentations during this year’s AACR (Free AACR Whitepaper)-NCI-EORTC, which is among the most prominent scientific gatherings addressing drug discovery and molecular targets," stated Ping Cao, Ph.D., Co-Founder and CEO of BridGene Biosciences. "Our posters will illustrate how the work at BridGene has the potential to address multiple therapeutic areas and bring game-changing capabilities to drug discovery and development. Overall, the posters describe our IMTAC platform technology and its capabilities, the discovery of novel small molecule inhibitors for undruggable targets, and the identification of previously unknown targets for approved small molecule drugs. We look forward to having this opportunity to showcase the potential of BridGene’s technology."

Information about the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC conference may be accessed here.

About AACR (Free AACR Whitepaper)
The American Association for Cancer Research (AACR) (Free AACR Whitepaper) is the first and largest cancer research organization dedicated to accelerating the conquest of cancer. Through its programs and services, the AACR (Free AACR Whitepaper) fosters research in cancer and related biomedical science; accelerates the dissemination of new research findings among scientists and others dedicated to the conquest of cancer; promotes science education and training; and advances the understanding of cancer etiology, prevention, diagnosis, and treatment throughout the world.

On September 30, 2021, Exicure, Inc. ("Exicure") and Exicure Operating Company, Exicure’s wholly owned subsidiary (collectively with Exicure, the "Company") reported that entered into an amendment ("Amendment No. 3") to the Company’s Credit and Security Agreement, dated as of September 25, 2020, as amended on October 21, 2020 and July 30, 2021, with MidCap Financial Trust, as agent, and the lenders party thereto from time to time (as amended by Amendment No. 3, the "Credit Agreement") (Filing, 8-K, Exicure, SEP 30, 2021, View Source [SID1234590895]).

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Amendment No. 3 extends the availability of the second advance of $7.5 million under the Credit Agreement from September 30, 2021 to December 31, 2021, subject to the Company’s satisfaction of certain applicable funding conditions as described in Amendment No. 3, including i.) Exicure’s issuance of equity interests, subject to certain limitations, resulting in receipt by Exicure of unrestricted net cash proceeds of at least $20.0 million, and ii.) the contribution by Exicure, and receipt by Exicure Operating Company, of such cash proceeds to the capital of Exicure Operating Company.

On September 30, 2021 Acacia Pharma Group plc ("Acacia Pharma", the "Group" or the "Company") (EURONEXT: ACPH), a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures or cancer chemotherapy, reported its results for the six month period ended 30 June 2021 and provides an update on the commercial progress of Barhemsys and Byfavo in the United States (Press release, Acacia Pharma, SEP 30, 2021, View Source [SID1234590521]).

A presentation of interim results by Acacia Pharma’s senior management team will be webcast (listen only) live later today 30 September at 14.00 CEST (08.00 EST) and participants can register by clicking here or from www.acaciapharma.com. A replay will be available after the event at the same link.

International conference call dial-in details are noted below with callers able to participate in a Q&A.

The results report will be available at www.acaciapharma.com in the Investors section from 07.00 CEST today and the presentation will be made available before the start of the call.

As previously announced, Acacia will also hold a KOL webinar later today at 18.00 CEST/12.00 EDT to discuss the hospital user experience with Barhemsys and Byfavo. Advanced registration is required, and details can be found on our website under the Media/Events section.

Commenting on the results, Mike Bolinder, Chief Executive Officer, said: "We continue to make significant progress towards becoming a leading US hospital pharmaceutical company. During the first half, our team has done an exceptional job executing on our corporate objectives, despite the challenging operating environment posed by the global pandemic. The commercial launches of both Barhemsys and Byfavo are making excellent progress in terms of formulary access, the most important measure of success in this early phase of their commercialization. Given this strong performance, we remain on track to meet our annual formulary goals for both products.

"One key early indicator of the sales potential of both products is the overwhelmingly positive feedback we have received from customers about their initial experiences. They have been very impressed at how rapidly both drugs have been able to improve their care for patients.

"We continue to experience high levels of engagement and support from Key Opinion Leaders and many of the largest academic institutions across the country. We have already begun the pediatric study for Byfavo at study sites in some of the most well-known and respected pediatric centers in the U.S.

"With Barhemsys, we are planning to initiate our Phase 4 PROMPT study, which is designed to gather real-world evidence on the benefits of using the drug. We believe this study can help quantify and document the difference Barhemsys makes in the real-world setting which will provide further important data to support our marketing efforts. We are also very pleased to report that the Marketing Authorization Application (MAA) for Barhemsys has been submitted, validated and is now under formal review in major European markets and we are working diligently to progress international licensing agreements ahead of the product’s anticipated European approval in 2022.

"Lastly, we have continued to make strong progress at the corporate level. We raised €27m (c$33m) in February, made an early repayment of the outstanding Hercules loan facility thereby lowering our borrowing costs and continue to tightly manage our cash burn. Additionally, we were very excited to have appointed Deb Hussain as our new Chief Commercial Officer who brings tremendous knowledge and experience to the organization."

Operating Highlights for First Half 2021

Barhemsys and Byfavo launches continue to track well despite the challenging operating environment caused by the global pandemic
Barhemsys (amisulpride injection)
Sales team began customer engagement in October 2020
To date, 260 accounts on formulary with >80% win rate
Well on track to meet our formulary goal (300 accounts) by year end despite continued COVID-19 related access restrictions
Partnering with key institutions to begin the Barhemsys PROMPT study to gather real-world evidence
MAA submitted, validated and now under formal review in major European markets
Byfavo (remimazolam injection)
Launched in the U.S. at the end of January 2021
To date, 95 accounts on formulary with >90% win rate
On track to meet our formulary goal (150 accounts) by year end
Byfavo pediatric study initiated
Commercial traction for both products continues to be strong
Positive feedback from customers on initial experience with Byfavo and Barhemsys
Engagement with KOLs and key institutions remains high
Phase 4 studies being initiated to expand usage
Significant addressable markets for both products
Appointment of new Chief Commercial Officer
Deb Hussain joined as Chief Commercial Officer in May 2021 after having spent over 20 years at Eli Lilly and Company, where she led some of the largest and most successful brands in the industry and had profit and loss responsibility for over $2 billion of revenue.
Financial Highlights

Results are presented in US$, reflecting the currency of the majority of expected costs and revenues

Equity financing of €27m (c$33m) completed in February 2021. Early repayment of Hercules loan completed in May 2021
Cash and cash equivalents were $47.1m at 30 June 2021 (30 June 2020: $24.6m, 31 December 2020: $46.7m)
Net revenue for the first half of 2021 was $0.4m (1H 2020: $0.0m)
Operating loss for the period was $24.9m (1H 2020: $12.8m) as the Group has invested in the launch and commercialization of Barhemsys and Byfavo
G&A costs increased $4.1m in 1H 2021 to $8.5m (1H 2020: $4.4m) mainly as a result of the amortization of the Byfavo license ($4.1m)
R&D activities have been focused on meeting FDA post-marketing commitments for both Barhemsys and Byfavo. R&D costs in the first half of 2021 increased to $2.1m (1H 2020: $0.6m) as the development activities in relation to our post-marketing commitments were initiated
Basic loss per share for the first half of 2021 was $0.31 (H1 2020: $0.24) reflecting greater commercial spend and incorporating an increase of 24.8 million shares following the equity raises in August 2020 and February 2021 (1H 2021: 88.7 million average shares outstanding; 1H 2020: 63.9 million average shares outstsanding).
Summary and Outlook for 2021

Acacia Pharma is on track to meet its formulary goals for both Barhemsys and Byfavo for the full year 2021 and the Company has been very encouraged by the positive user feedback received for both products.

The markets being addressed initially are large and the Company is confident that these products will successfully address the current unmet needs in PONV and procedural sedation. A series of Phase 4 studies is now being initiated to provide further impetus and data to expand into additional market segments for both Barhemsys and Byfavo over the longer term.

Furthermore, with the highly experienced team put in place and the strong early foundation being built for Barhemsys and Byfavo through formulary access, we believe Acacia Pharma is well positioned to deliver significant commercial success in the future.

Conference call dial-in details

To join the conference call by telephone, please dial-in 5-10 minutes prior to the start using the password Acacia Pharma and any of the phone numbers provided below.

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