On May 12, 2021 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported its financial results for the first quarter 2021 and business highlights, including an update on its progress with fadraciclib and CYC140, Cyclacel’s novel CDK2/9 and PLK1 inhibitors, respectively (Press release, Cyclacel, MAY 12, 2021, View Source [SID1234579849]).

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"During the quarter, we have made significant progress in bringing our two oral targeted development candidates into mid-stage clinical development. Following recent FDA authorization of our IND for oral fadraciclib, we will finalize contract discussions with sites and open our multi-cohort Phase 1b/2 study in patients with solid tumors," said Spiro Rombotis, President and Chief Executive Officer. "We believe fadraciclib is establishing a strong position among compounds in clinical development that specifically address cancer resistance mechanisms, including suppression of MCL1, MYC and cyclin E. A recent publication identified potential utility of CDK9 inhibitors in KRAS mutant colorectal cancer, one of the tumor types in our study. Together with our oral CYC140 PLK1 inhibitor program, which has shown in preclinical models that KRAS mutant cancers are sensitive to CYC140 inhibition, we hope to provide valuable alternatives to patients with these difficult to treat malignancies. After strengthening our balance sheet in the quarter, we are executing a precision medicine strategy to achieve multiple milestones and data read outs over the next two years."

Key Corporate Highlights

CYC065-101 Phase 1b/2 oral fadraciclib in advanced solid tumors – announced that the U.S. Food & Drug Administration (FDA) has authorized Cyclacel’s Investigational New Drug (IND) application for oral fadraciclib to proceed. This Phase 1b/2 registration-directed trial includes multiple cohorts defined by histology thought to be sensitive to the drug’s mechanism of action and informed by the clinical activity of fadraciclib in MCL1, MYC and cyclin E amplified cancers. The cohorts include breast, colorectal (including KRAS mutant), endometrial/uterine, ovarian cancers and certain lymphomas. The study design also includes a basket cohort which will enroll patients with relevant biomarkers to the drug’s mechanism regardless of histology.

A recent publication by researchers led by Frank McCormick, PhD of University of California San Francisco and NCI’s Frederick National Lab for Cancer Research reported that overactive KRAS mutants are impeded by CDK9 inhibition1. These data expand on previous findings, which show that dual CDK2/9 inhibition is an optimal strategy to treat colorectal cancer2, that KRAS mutant pancreatic cancer is sensitive to CDK9 inhibition3, and that fadraciclib showed efficacy against KRAS mutant lung cancer in preclinical PDX models4. Collectively these publications suggest the potential for the therapeutic use of fadraciclib in KRAS-mutated cancers, including colorectal, lung and pancreatic.

CYC140 PLK1 inhibitor program – commenced IND-directed activities and manufacturing of clinical trial supplies for oral CYC140. Initial data in preclinical models show that KRAS mutant cancers are sensitive to oral CYC140 inhibition.

Phase 1b/2 Investigator Sponsored Trial (IST) of sapacitabine-olaparib combination in patients with BRCA mutant metastatic breast cancer – investigators reported that out of 9 patients enrolled, 5 have achieved partial response (PR), 3 stable disease (SD), and one patient has progressed.

Announced the closing of an underwritten public offering for net proceeds to the Company of approximately $13.5 million, after deducting placement agent fees and other offering expenses. Existing and new institutional investors participated in the offering. In addition, the Company received approximately $4.5 million in the quarter through warrant exercises.

Key Near-Term Business Objectives and Expected Timeline

1H 2021

First patient dosed with oral fadraciclib in Phase 1b/2 advanced solid tumor study
2H 2021

First patient dosed with oral fadraciclib in Phase 1b/2 leukemia study
First patient dosed with oral CYC140 in Phase 1/2 advanced solid tumor study
1H 2022

First patient dosed with oral CYC140 in Phase 1/2 leukemia study
Phase 1 data with oral fadraciclib in advanced solid tumor study
Update data from the Phase 1b/2 IST of sapacitabine-olaparib combination in patients with BRCA mutant metastatic breast cancer when reported by the investigators
Financial Highlights

As of March 31, 2021, cash and cash equivalents totaled $47.8 million, compared to $33.4 million as of December 31, 2020. The increase of $14.4 million was primarily due to $18.0 million of net cash provided by financing activities, offset by net cash used in operating activities of $3.6 million. There were no revenues for each of the three months ended March 31, 2021 and 2020.

Research and development expenses were $2.6 million for the three months ended March 31, 2021 as compared to $1.1 million for the same period in 2020. Research and development expenses relating to the CDK inhibitor program increased by approximately $0.8 million for the three months ended March 31, 2021 as clinical evaluation of fadraciclib is progressing.

General and administrative expenses for the three months ended March 31, 2021 were $1.7 million, compared to $1.3 million for the same period of the previous year due to an increase in legal and professional expenses and recruitment costs.

Total other income, net, for the three months ended March 31, 2021 was $0.1 million, compared to $0.9 million for the same period of the previous year. The decrease of $0.8 million for the three months ended March 31, 2021 is primarily related to income received under an Asset Purchase Agreement with Thermo Fisher Scientific Inc.

United Kingdom research & development tax credits were $0.7 million for the three months ended March 31, 2021, as compared to $0.3 million for the same period in 2020 as a direct consequence of increased qualifying research and development expenditure.

Net loss for the three months ended March 31, 2021 was $3.5 million, compared to $1.2 million for the same period in 2020.

The Company raised net proceeds of approximately $13.5 million from an equity financing in March 2021. The Company also received an additional $4.5 million of proceeds from warrant exercises.

The Company estimates that cash resources of $47.8 million as of March 31, 2021 will fund currently planned programs through early 2023.

On May 12, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported that the company’s Hong Kong subsidiary, Pangu BioPharma Limited (Pangu), together with the Hong Kong University of Science and Technology (HKUST), have achieved the milestones set forth for the first year of a $750,000 grant received from the Hong Kong Government’s Innovation and Technology Commission (ITC) (Press release, aTyr Pharma, MAY 12, 2021, View Source [SID1234579834]). The two-year project, which is in part funded by the ITC’s Partnership Research Program (PRP), is intended to develop a high-throughput platform for the development of bispecific antibodies with an initial focus on diseases in which Neuropilin-2 (NRP2) overexpression is strongly implicated, including cancer.

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Key milestones achieved for the first year of the project included building out a highly skilled research team to establish an innovative antibody discovery platform at HKUST. An integral part of this project was the development and implementation of a novel single-cell antibody discovery approach which has so far yielded numerous candidate high-affinity NRP2/co-receptor antibodies that are currently being screened in functional assays. The second year of the project aims to identify the most productive pairings, optimize mid-scale production/purification and prioritize lead candidate bispecific antibodies based on activity in therapeutically relevant cell-based assays.

"We are very pleased with the progress of Pangu and HKUST in the first year of this important project," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "We continue to learn more about NRP2 as a target for diseases, including immunology and cancer. Based on its role in regulating inflammatory responses and interaction with various co-receptors, we believe there are several potential options to therapeutically target NRP2 and that bispecific antibodies present a unique approach to create highly-specific agonists of this system which may be therapeutically relevant in certain disease states. We look forward to the outcome from the second year of the project."

Mingjie Zhang, Ph.D., Chair Professor of the Division of Life Science and Kerry Holdings Professor of Science at HKUST and project coordinator of the Pangu collaboration, commented, "We are excited to have implemented this new antibody discovery platform as part of the collaboration between Pangu and HKUST. We look forward to utilizing the additional capabilities related to bispecific antibody development that this platform supports to enable us to achieve our goals in the second year of the project."

About NRP2

Neuropilin-2 (NRP2) is a cell surface receptor that plays a key role in lymphatic development and in regulating inflammatory responses. In many forms of cancer, high NRP2 expression is associated with worse outcomes. NRP2 can interact with multiple ligands and co-receptors through distinct domains to influence their functional roles, making it a potential drug target with multiple distinct therapeutic applications. NRP2 interacts with type 3 semaphorins and plexins to impact inflammation and with forms of vascular endothelial growth factor (VEGF) and their receptors, to impact lymphangiogenesis. In addition, NRP2 modulates interactions between CCL21 and CCR7 potentially impacting homing of dendritic cells to lymphoid organs. aTyr is currently investigating NRP2 receptor biology, both internally and in collaboration with key academic thought leaders, as a novel target for new product candidates for a variety of diseases, including cancer and inflammation.

On May 12, 2021 Ryvu Therapeutics (WSE: RVU) reported its first quarter 2021 financial results and provided a corporate update (Press release, Ryvu Therapeutics, MAY 12, 2021, View Source [SID1234579833]).

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"Q1 2021 was an eventful quarter for Ryvu and developments around RVU120 played a key role in it" – commented Pawel Przewiezlikowski, Chief Executive Officer of Ryvu. "We have submitted a clinical trial application to conduct a Phase I/II study of RVU120 in patients with solid tumors, and shortly after that we received an approval to expand the ongoing Phase I of RVU120 in AML and high risk MDS from US sites to Poland. We have also secured a non-dilutive grant to finance the RVU120 solid tumor study. Despite the recent partial clinical hold imposed on RVU120 Phase Ib study, we have achieved meaningful research progress in our clinical and pre-clinical pipeline in these first months of 2021. Patient safety is Ryvu’s priority, and we are working diligently to answer the FDA questions and expect to resume study enrollment as soon as possible. At the same time we believe that RVU120 continues to be a promising treatment option for cancer patients and we hope to soon resume investigating the therapeutic potential which this compound holds" – adds Przewiezlikowski.

Recent Achievements

RVU120 Solid Tumor CTA submission
On January 04, Ryvu submitted a new Clinical Trial Application (CTA), seeking approval to commence a Phase I/II trial, investigating the safety and efficacy of RVU120 (SEL120), a first-in-class, selective oral CDK8/19 inhibitor, in patients with relapsed/refractory metastatic or advanced solid tumors. The CTA has been submitted to the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and to the study Central Ethics Committee. Following the approval of the CTA, expected in H1 2021, Ryvu Therapeutics will be able to activate the selected clinical sites in Poland and start enrolling patients.

RVU120 AML CTA approval
On January 07, Ryvu announced that its Clinical Trial Application (CTA) to commence the first-in-human (FIH), Phase I trial investigating RVU120, in patients with Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (HRMDS), who have failed the prior standard treatment, has been fully approved by the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, and the respective Central Ethics Committee. Following these approvals, Ryvu can expand the clinical trial ongoing in the United States to Poland, aiming to assess the safety and tolerability of RVU120 and to determine the recommended Phase II dose (RP2D) of the study drug, in participants with AML or HRMDS.

USD 5 million non-dilutive grant financing secured
On January 18, Ryvu announced that its project titled "Clinical development of an innovative drug candidate in solid tumors", which focuses on Phase I/II evaluation of RVU120 in patients with solid tumors, has been approved for financing by the National Center for Research and Development (NCBiR). This grant provides Ryvu with $5.0 million of non-dilutive financing. The total net value of the project amounts to $11.1 million and the anticipated project duration is until December 2023.

Distinction in Warsaw Stock Exchange Company of the Year competition
On March 16, Ryvu was awarded third place in the "Products and Services Innovation" category in the Warsaw Stock Exchange Company of the Year competition. The Stock Exchange Company of the Year competition is organized by "Puls Biznesu" – one of the largest business daily publications in Poland. It was the 22nd edition of the competition, the oldest and the most prestigious ranking in the Polish capital market. Every year the best publicly traded companies on the Warsaw stock exchange are awarded by a jury comprised of market analysts, investment advisers and managers, institutional investors, and securities house representatives.

Important milestones in 2021, before the report date

On April 10-15, Ryvu presented recent data from multiple oncology programs at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting 2021. Data presented included results from the RVU120, a CDK8/CDK19 inhibitor program, as well as data from small-molecule STING agonists and HPK1 inhibitor projects. Presented posters can be downloaded from Ryvu’s website: View Source
On April 08, Ryvu announced the U.S. Food and Drug Administration placed a partial clinical hold on the first-in-human Phase Ib, dose escalation clinical trial of RVU120 in patients with relapsed/refractory (R/R) AML and high-risk MDS, being conducted in the United States. Patients who are currently taking RVU120 may continue treatment in the study, but no new patients may be enrolled in the study until the partial clinical hold is lifted by the FDA.
The partial clinical hold was initiated following Ryvu’s recent report to the FDA of a Serious Adverse Event involving a patient death, classified as possibly related to RVU120. One of the two patients enrolled in Cohort 5, 110 mg dose level, of RVU120 experienced a fatal incidence of "Worsening Pancreatitis". The other patient in the same dose cohort, completed the 1st treatment cycle without any serious adverse events (SAE) reported by the investigational site and entered Cycle 2. There are currently two patients continuing to receive treatment with RVU120 in the study.
On April 26, Ryvu announced the appointment of Vatnak Vat-Ho to the role of Chief Business Officer. As CBO, Mr. Vat-Ho will be responsible for a wide scope of corporate and business development activities at Ryvu including strategic positioning, partnering discussions, alliance management as well as investor interactions.
In Q1 2021, Ryvu Therapeutics participated and presented at several investor conferences, including Solebury Trout 1×1 Management Access Event, HCW Bioconnect Conference, IPOPEMA & Sova Capital: EM Medical/Healthcare Day, BIO-Europe Spring 2021 and AACR (Free AACR Whitepaper) Virtual Annual Meeting 2021.

Ryvu First Quarter 2021, Financial Results

In the past quarter, Ryvu Therapeutics noted a 51% decrease in its revenues, down to PLN 6.6 million ($1.8 million). Revenues from subsidies have slightly increased from PLN 5.7 million ($1.5 million) in Q1 2020, up to PLN 6.1 million ($1.6 million) in Q1 2021, however, there were no significant partnering revenues in Q1 2021 compared to Q1 2020, when milestone from SEL24 / MEN1703 was recognized.

Operational costs related in majority to the research and development expenditures, increased by 20% to PLN 22.3 million ($5.9 million), as compared to PLN 18.6 million ($4.7 million) in first quarter last year. Operational loss has increased and amounted to PLN 15.7 million ($4.1 million), compared to PLN 5.0 million ($1.3 million) in Q1 2020.

On May 5, 2021, Ryvu Therapeutics held PLN 129.3 million ($32.6 million) in cash, cash equivalents, and short-term investments.

On May 12, 2021 Sosei Group Corporation ("the Company") (TSE: 4565) provides an update on operational activities and reported its consolidated results for the first quarter ended 31 March 2021 (Press release, Sosei, MAY 12, 2021, View Source [SID1234579832]). The full report can be accessed by clicking here.

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Shinichi Tamura, Chairman, President and CEO of Sosei Heptares, commented: "We continue to make good progress expanding our drug discovery business and remain well positioned to capitalize on a range of growth opportunities. We have initiated several exciting new technology collaborations designed to enhance our world-leading discovery platform and extend the reach of its application, including beyond GPCRs for the first time. We have made good progress with our partnered programs, which have delivered multiple milestones and generated important revenues since the start of the year. Meanwhile, our inhouse programs provide us with a rich source of future partnering opportunities that we are exploring. We have ambitious plans and expect 2021 to be a year of increased investment in strategic growth initiatives, both organic and inorganic, and believe we have the right strategy to deliver continued success and value creation for all stakeholders."

Operational Highlights for Q1 2021

New strategic technology collaboration with PharmEnable for AI-driven drug discovery – aim to identify new leads against a challenging "peptidergic" GPCR target
First strategic collaboration to explore SBDD approaches beyond GPCRs with Metrion Biosciences – collaboration targeting ion channels, a large, under-exploited target class where structural input to drug discovery has been limited. Drug discovery program to identify novel, highly specific leads for further development against a single ion channel associated with neurological diseases.
Worldwide rights to out-licensed muscarinic agonist programs regained from AbbVie/Allergan – independent review of programs has completed, with increased investment allocated to advance the HTL0016878 selective muscarinic M4 agonist through clinical studies and build value ahead of future partnering. HTL0016878 represents a unique opportunity to develop a novel therapeutic with a new mechanism of action for neurological disorders including schizophrenia. Negotiations for collaborations on this and other muscarinic programs are now in progress.
Two milestone payments totalling US$4 million received from Genentech during Q1 2021 – milestones achieved from the delivery of StaR proteins based on nominated targets under the 2019 multi-target agreement.
Spin-off company Orexia Therapeutics merged into Centessa Pharmaceuticals, a new asset-centric company – Orexia became one of ten private companies merged into Centessa, which launched in February 2021 and raised US$250 million. Sosei Heptares’ equity holding in Orexia was converted into a proportional shareholding in Centessa, which filed for an Initial Public Offering on Nasdaq in April 2021.
US$2.5 million milestone received from Formosa Pharmaceuticals – based on progression of APP13007, a divested asset, into Phase 3 trials as a new potential treatment for pain and inflammation following cataract surgery.
Financial Highlights for the Three-month Period ended 31 March 2021

Revenue totalled JPY 1,207 million (US$11.4 million*), an increase of JPY 45 million (US$0.7 million) vs. the prior corresponding period. The increase was due to (i) the achievement of two milestones totalling US$4.0 million in Q1 2021 relating to the delivery of StaR proteins provided to Genentech (in respect of which US$2.1 million has been recognised) vs. the achievement of one US$1.5 million milestone in Q1 2020, and (ii) larger releases of deferred revenue in Q1 2021 due to there being an additional contract in the current quarter in respect of which revenue had been deferred in the past (AbbVie).
Cash R&D expenses totalled JPY 1,102 million (US$10.4 million), an increase of JPY 545 million (US$5.3 million) vs. the prior corresponding period. The increase relates primarily to (i) spend on new innovative research collaborations, including Metrion, PharmEnable and Captor; (ii) an expansion in R&D headcount to support the growth of the business; (iii) a low level of spend in the comparative period, which included some non-recurring credits, including the successful resolution of disputed costs charged by one supplier; and (iv) a stronger GBP vs. JPY.
Cash G&A expenses totalled JPY 641 million (US$6.0 million), an increase of JPY 204 million (US$2.0 million) vs. the prior corresponding period. The increase is primarily due to an increase in personnel related expenses. In the prior corresponding period, personnel related expenses were lower as a result of a reduction in the UK share based payment related National Insurance liability, which was driven by share price movements in that particular quarter.
Cash earnings net loss** totalled JPY 683 million (US$6.4 million), vs. a cash profit of JPY 12 million (US$0.1 million) in the prior corresponding period. The main reason for the increase in the operating loss is that the increase in Cash R&D and G&A costs exceeded the increase in revenue.
Operating loss totalled JPY 1,238 million (US$11.7 million) (vs. an operating loss of JPY 445 million (US$4.1 million in the prior corresponding period). The main reason for the increase in the operating loss is that the increase in operating expenses exceeded the increase in revenue.
Net loss totalled JPY 1,153 million (US$10.9 million) vs. a net loss of JPY 746 million (US$6.9 million) in the prior corresponding period. The main reason for the net loss is the increase in operating loss (for the reasons stated above).
Cash and cash equivalents as at March 31, 2021 increased by JPY 388 million (US$3.7 million) from the beginning of the year and amounted to JPY 40,396 million (US$364.8 million).
*Convenience conversion to US$ at the following rates: 2021: 1US$ =106.092 JPY; 2020: 1US$ =108.907 JPY

On May 12, 2021 Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), a leading computational biology company aiming to revolutionize life-science product development across several market segments, reported that it will release its financial results for the first quarter of 2021 on Wednesday, May 26th, 2021 (Press release, Evogene, MAY 12, 2021, View Source [SID1234579831]). Mr. Ido Dor, Chief Executive Officer of Evogene’s subsidiary, Lavie Bio Ltd., will join the conference call to discuss Lavie Bio’s recent activity.

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On the day of the announcement, the Company’s management will host a conference call to discuss the results at 09:00 AM Eastern time, 16:00 Israel time. To access the conference call, please dial +1-888-281-1167 toll free from the United States, or +972-3-918-0609 internationally. Access to the call will also be available via live webcast through the Company’s website at www.evogene.com.

A replay of the conference call will be available approximately two hours following the completion of the call. To access the replay, please dial 1-888-326-9310 toll free from the United States, or +972-3-925-5901 internationally. The replay will be accessible through May 28th, and an archive of the webcast will be available on the webcast link for the following twelve months.