On March 28, 2022 Acacia Pharma Group PLC reported that proposed Transaction with Eagle Pharmaceuticals PLC (Press release, Acacia Pharma, MAR 28, 2022, View Source [SID1234611029])

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Key highlights

Acacia Pharma Group PLC ("Acacia") met its formulary goals for both Barhemsys and Byfavo in FY2021 and continues to be encouraged that feedback for both products is indicative of significant future commercial potential.
However, Acacia’s standalone financial condition has been negatively impacted by physical access limitations caused by the global COVID-19 pandemic, and a significant latency of demand due to postponement of surgical procedures. Accordingly, Acacia expects it would require a minimum of approximately US$115m of additional cash to fund operations to break-even (based on projections assuming break-even by early FY2025).
As a result, the Acacia Board appointed Greenhill to undertake a comprehensive review of strategic alternatives available to maximise value for Acacia Shareholders. The review included consideration of options to raise additional capital, but found that the terms on which such capital was likely to be available would have led to significant dilution and potential destruction of value for Acacia Shareholders.
Following this comprehensive exploration and assessment of all strategic alternatives, the board of directors of Acacia and the board of directors of Eagle Pharmaceuticals, Inc. ("Eagle") hereby announce that they have reached agreement on the terms of a transfer of the entire issued and to be issued share capital of Acacia to Eagle by way of a scheme of arrangement under Part 26 of the Companies Act 2006 (the "Proposed Transaction").
Under the terms of the Proposed Transaction, each Scheme Shareholder will receive as consideration (the "Consideration"):
for each Scheme Share, €0.68 in cash and 0.0049 New Eagle Shares

The Proposed Transaction values Acacia’s existing issued and to be issued share capital at approximately €94.7 million on a fully diluted basis.
The cash portion of the Consideration represents approximately 75 per cent. of the total Consideration, and the New Eagle Shares that Acacia Shareholders would receive represent approximately 25 per cent. of the total Consideration, which represents approximately 3.8 per cent. of the enlarged Eagle share capital in issue immediately following completion of the Scheme. The total Consideration equates to €0.90 for each Scheme Share.
The Consideration provides Acacia Shareholders with both up-front cash and, through the New Eagle Shares to be acquired by Acacia Shareholders, equity participation in the value creation potential for the enlarged business through de-risked funding requirements, enlarged group synergies, and being part of a well-funded entity with shares trading on a liquid exchange.
Having considered all of the available alternatives as part of its strategic review, the Acacia Board believes that the Proposed Transaction represents the best option for Acacia Shareholders to maximise the value of their shares, and therefore unanimously recommends the Proposed Transaction.
Furthermore, the Acacia Board considers that there is a significant risk that if the Scheme is not approved by the necessary number of Acacia Shareholders, this could lead to a very material reduction in the value attributable to Acacia Shares and/or an insolvency procedure relating to the Acacia Group, which could in turn result in negligible (if any) value being attributable to Acacia Shares.
In making its recommendation, the board of Acacia has considered the financial position of Acacia given the significant operational challenges as a result of the limited physical access to institutions resulting from the global COVID-19 pandemic, as well as the significant latency of demand due to the postponement of non-essential surgical procedures, as a result of which the Acacia Group has experienced a significant reduction in its available liquidity as the net revenue in 2021 and so far in 2022 continues to lag behind expectations.
Recommendation, irrevocable undertakings and shareholder support for the Proposed Transaction

The Acacia Directors consider the Proposed Transaction to be the best available option for Acacia Shareholders. In making this assessment, the Acacia Directors have received financial advice from Greenhill who, in providing its financial advice, has taken into account the commercial assessments of the Acacia Directors. Accordingly, the Acacia Directors intend unanimously to recommend that Acacia Shareholders vote in favour of the Scheme at the Court Meeting and the Resolutions to be proposed at the General Meeting, as the Acacia Directors have irrevocably undertaken to do in respect of the 217,543 Acacia Shares which they hold and which they control (or can procure the control of) the voting rights, representing approximately 0.22 per cent. of the issued share capital of Acacia on 25 March 2022, being the last business day before this announcement.
In addition to the irrevocable undertakings referred to above, Eagle has also received irrevocable undertakings from the three largest shareholders of Acacia to vote in favour of the Scheme at the Court Meeting and the Resolutions to be proposed at the General Meeting in respect of the 49,012,875 Acacia Shares which they hold and which they control (or can procure the control of) the voting rights, representing approximately 48.56 per cent. of the issued share capital of Acacia on 25 March 2022, being the last business day before this announcement.
Therefore, Eagle has received irrevocable undertakings representing, in aggregate, 49,230,418 Acacia Shares representing approximately 48.78 per cent. of the issued share capital of Acacia.
Further details of these irrevocable undertakings, including the circumstances in which they cease to be binding, are set out in Appendix 3 to this announcement.
Information on Eagle

Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients’ lives. Eagle’s commercialised products include vasopressin injection, PEMFEXY, RYANODEX, BENDEKA, BELRAPZO, TREAKISYM (Japan), and its oncology and CNS/metabolic critical care pipeline includes product candidates with the potential to address underserved therapeutic areas across multiple disease states. Additional information is available on Eagle’s website at www.eagleus.com.
Eagle is listed with shares of its common stock publicly traded on Nasdaq under the trading symbol "EGRX" and has a market capitalisation of approximately US$615 million as at 25 March 2022, being the last business day before this announcement.
Comments on the Proposed Transaction

Commenting on the Proposed Transaction, Scott Byrd, Chairman of Acacia, said:
"I am proud of the progress that Acacia has achieved in bringing Barhemsys through clinical trials to the market and in the progress it has subsequently made in launching both this product and Byfavo in the US. Both products are designed to address clear and important hospital needs and to date have received positive feedback from customers and strong formulary acceptance, positioning them well for future success. However, the global COVID-19 pandemic has resulted in significant and sustained challenges that have significantly disrupted hospital operations, limited access, and dramatically increased the time and investment required for product launches.

The Acacia Board believes this Proposed Transaction represents an opportunity for Acacia shareholders to realise value for their investment in cash and, through Eagle, retain an interest in the future value that may be generated from Barhemsys and Byfavo being part of a larger portfolio of hospital products, in the hands of a well-capitalised company. We are therefore unanimously recommending this Proposed Transaction to our shareholders."

Commenting on the Proposed Transaction, Scott Tarriff, President and Chief Executive Officer of Eagle, said:
"We are delighted to announce that we have agreed to terms for the proposed acquisition of Acacia. This will be a very important acquisition for us, both financially and strategically. In recent years, the pharmaceutical industry has witnessed slower uptake of new products and longer ramp periods. In the face of further challenges brought about by the COVID-19 pandemic, many smaller underfunded companies experienced significant hurdles launching products. We therefore believe that Eagle is well suited to drive uptake of these two new products, building from Acacia’s established foundation since its launch, through our experienced and specialised hospital-based sales organisation with minimal additional infrastructure."

Timetable

The Proposed Transaction will be implemented by means of a Court-sanctioned scheme of arrangement between Acacia and the Scheme Shareholders under Part 26 of the Companies Act.
he Scheme Document, containing further information about the Proposed Transaction and notices of the Court Meeting and General Meeting, together with the Forms of Proxy, will be sent to Acacia Shareholders and (for information only) participants in the Acacia Share Schemes as soon as reasonably practicable. An expected timetable of principal events will be included in the Scheme Document.
The Scheme is expected to become effective between the middle of May 2022 and 30 June 2022, subject to the satisfaction (or, where applicable, waiver) of the terms set out in Appendix 1 to this announcement.
This summary should be read in conjunction with, and is subject to, the full text of the following announcement (including its Appendices). The Proposed Transaction will be subject to the terms set out in Appendix 1 and to the full terms and conditions to be set out in the Scheme Document. Appendix 2 contains the sources and bases of certain information contained in this summary and the following announcement. Appendix 3 contains details of the irrevocable undertakings received by Eagle. Appendix 4 contains the definitions of certain terms used in this summary and the following announcement.

On March 28, 2022 Ayala Pharmaceuticals, Inc. (Ayala or the Company) (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers reported full-year 2021 financial results and provided a corporate update (Press release, Ayala Pharmaceuticals, MAR 28, 2022, View Source [SID1234611050]).

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"2022 is off to a very promising start for Ayala, following a number of important accomplishments across our pipeline of innovative gamma-secretase inhibitors in 2021," said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. "We are pleased with the progress of our AL102 program in desmoid tumors, having recently completed enrollment in Part A of the open label RINGSIDE study. We are encouraged by initial positive feedback received from investigators so far. We plan to announce initial interim data from Part A around mid-year 2022 and intend to move into Part B, the randomized portion of the study, immediately thereafter. We look forward to announcing additional data readouts and updates on our other clinical programs throughout 2022 including further data on AL101 in adenoid cystic carcinoma."

2021 and Recent Business and Clinical Highlights

Completed enrollment of Part A of the Phase 2/3 RINGSIDE study of AL102 in desmoid tumors: 36 patients have been enrolled in Part A of the RINGSIDE study, which is evaluating the safety and tolerability of AL102, as well as tumor volume by MRI at 16 weeks. Ayala expects to report an initial interim data read-out around mid-2022, with Part B of the study commencing immediately thereafter.
Initiated "Window of Opportunity" study of AL101 in adenoid cystic carcinoma (ACC): The study is focused on determining the effects of AL101 for the treatment of ACC and other cancers. The goals of the study are to better understand the mechanism of AL101, determine the best treatment regime and generate data for the future development strategy. The study is being conducted in collaboration with M.D. Anderson Cancer Center and the Adenoid Cystic Carcinoma Research Foundation.
Presented positive preliminary clinical data from the ongoing ACCURACY trial in ACC: Updated interim data from the 6mg cohort of the Phase 2 ACCURACY study of AL101 in recurrent/metastatic adenoid cystic carcinoma (R/M ACC) were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 demonstrating partial responses in three subjects (9%) and stable disease in 20 subjects (61%). At ESMO (Free ESMO Whitepaper), the Company also presented preclinical proof of concept data on AL101 in combination with approved cancer therapies in patient-derived ACC tumor models
Initiated Phase 1 trial of AL102 in combination with Novartis’ B-cell maturation antigen (BCMA) targeting agent WVT078 in relapsed/refractory multiple myeloma (MM): inhibition of gamma-secretase with AL102 prevents the cleavage and shedding of BCMA, which is ubiquitously expressed on MM cells. Preclinical data have demonstrated that treatment with AL102 increases the expression of membrane-bound BCMA on the surface of MM cells and could enhance the activity of WVT078. Ongoing patient enrollment continues as planned.
AL101 in Notch-activated triple negative breast cancer: The Company has elected to discontinue the Phase 2 TENACITY study as part of its efforts to focus its resources on the more advanced programs and studies including the RINGSIDE study in desmoid tumors and the ACCURACY study for ACC.
Upcoming Milestones

Initial interim data from the pivotal Phase 2/3 RINGSIDE trial in desmoid tumors (Mid-2022): Ayala expects to report an initial interim data read-out from Part A of the Phase 2/3 RINGSIDE trial of AL102 in desmoid tumors around mid-2022. Part B of the study will be a double-blind placebo-controlled study and will start immediately after dose selection from Part A.
Additional data from the Phase 2 ACCURACY trial of AL101 in ACC: The ongoing ACCURACY trial is an open-label, single-arm Phase 2 clinical trial evaluating AL101 as monotherapy for the treatment of R/M ACC patients with Notch-activated mutations. The first cohort of the trial included 45 subjects dosed at 4 mg of AL101 IV once weekly. Final data from the 4 mg cohort and additional data from the 6 mg cohort,which includes 42 subjects are expected to be reported in the second half of 2022.
Initiate Phase 2 Clinical Trial Evaluating AL102 in T-cell Acute Lymphoblastic Leukemia (T-ALL): Ayala plans to begin a Phase 2 clinical trial evaluating AL101 in R/R T-ALL in the second half of 2022.
Full Year 2021 Financial Results

Cash Position: Cash and cash equivalents were $37.3 million as of December 31, 2021, as compared to $42.4 million as of December 31, 2020.

Collaboration Revenue: Collaboration revenue was $3.5 million for the full year of 2021, as compared to $3.7 million for the full year of 2020.

R&D Expenses: Research and development expenses were $29.9 million for the full year 2021, compared to $22.4 million in 2020. The increase was primarily driven by additional costs in connection with the initiation and advancement of the Phase 2/3 RINGSIDE pivotal study for desmoid tumors.

G&A Expenses: General and administrative expenses were $9.3 million as of December 31, 2021, compared to $7.4 million as of December 31, 2020. The increase was primarily due to higher expenses in connection with our operations as a public company, including director and officer insurance, increased headcount, and stock-based compensation.

Net Loss: Net loss was $40.3 million for the full year 2021, resulting in basic and diluted net loss per share of ($2.80). This compares with a net loss was $30.1 million for the full year of 2020, equivalent to basic and diluted net loss per share of ($3.06).

For further details on the Company’s financial results, refer to our Annual Report on Form 10-K, for the year ended December 31, 2021 filed with the U.S. Securities and Exchange Commission (SEC) on March 28, 2022.

On March 28, 2022 ATCC, the world’s premier biological materials management and standards organization, reported that it has been awarded a two-year task order, with a ceiling value of $5.6 million, by the National Cancer Institute (NCI) (Press release, American Type Culture Collection (ATCC), MAR 28, 2022, View Source [SID1234611066]). This task order is part of the Company’s existing Indefinite Delivery/Indefinite Quantity (IDIQ) contract with NCI to support the Division of Cancer Epidemiology and Genetics (DCEG) Molecular Epidemiology Assay Support (MEAS) program.

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According to the DCEG website, its mission is to "discover the causes of cancer and inform the means for prevention by conducting transdisciplinary epidemiological and genetic research." DCEG investigators rely on contract services to provide technical support for specimen collection, receipt and processing, and assistance identifying laboratories to perform state-of-the-art testing using high-quality biological specimens collected from clinical and field sites. The MEAS program provides support services for clinical studies on the genetic and other cellular events that influence the onset of different types of cancer.

"At ATCC, we are committed to supporting members of the clinical research community by providing them with the highest quality biomaterials for cancer research," said Raymond H. Cypess, D.V.M., Ph.D., chairman and CEO of ATCC. "We know how important this is when they are designing studies to discover cancer’s genetic and environmental determinants and innovative approaches to cancer prevention. Scientific research is critical for unlocking incredible breakthroughs in global health."

Under the contract, ATCC may coordinate receipt of specimens from clinical and field sites, process fresh samples within 24 hours, and perform a broad range of state-of-the-art molecular assays to characterize the models as required. ATCC may also provide support services for the procurement, storage, and shipment of specimens to and from international and domestic specimen sites and prepare specimens for transport to testing laboratories by aliquoting, labeling, and batching, as needed.

"Through our expertise in providing standard reagents, functional testing, and biorepository operations and management, ATCC continues to support cancer research through DCEG’s clinical studies," said Joseph Leonelli, Ph.D., Senior Vice President of ATCC Federal Solutions. "We look forward to our continued relationship with NCI through the MEAS program."

On March 28, 2022 argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported the closing of its previously announced global offering of an aggregate of 2,333,334 ordinary shares (including ordinary shares represented by American Depositary Shares ("ADSs")) (Press release, argenx, MAR 28, 2022, View Source [SID1234611129]). The gross proceeds from the global offering were approximately $700 million (approximately €637 million).

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J.P. Morgan, Morgan Stanley, Cowen and SVB Leerink acted as joint bookrunning managers for the offering. Wells Fargo Securities, Kempen & Co, H.C. Wainwright & Co., Raymond James and Wedbush PacGrow acted as co-managers for the offering.

The securities were offered in the United States pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement relating to the securities was filed with the SEC on March 22, 2022 and a final prospectus supplement relating to the securities was filed with the SEC on March 25, 2022 and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the U.S. offering may be obtained for free from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; from Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attn: Prospectus Department, by email at [email protected], or by telephone at (866) 718-1649; from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926; or from SVB Securities LLC, Attn: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at 1-800-808-7525, ext. 6105, or by email at [email protected].

In addition, argenx announces the listing of and the commencement of dealings in its 2,333,334 new ordinary shares on the regulated market of Euronext Brussels.

This press release is for information purposes only and does not constitute, and should not be construed as, an offer to sell or the solicitation of an offer to buy or subscribe to any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale is not permitted or to any person or entity to whom it is unlawful to make such offer, solicitation or sale. Reference is also made to the restrictions set out in "Important information" below. This press release is not for publication or distribution, directly or indirectly, in or into any state or jurisdiction into which doing so would be unlawful or where a prior registration or approval is required for such purpose.

On March 28, 2022 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 and business highlights for the fourth quarter and full year ended December 31, 2021 (Press release, Cyclacel, MAR 28, 2022, View Source [SID1234611051]).

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"2021 was a year of solid execution, as the clinical and corporate objectives achieved by the Cyclacel team have positioned us to reach important milestones in 2022. These include initial data from the dose escalation stage of the ongoing Phase 1/2 study of fadraciclib, our CDK2/9 inhibitor, in advanced solid tumors", said Spiro Rombotis, President and Chief Executive Officer. "Enrollment has gone well with three new patients treated at dose level 4 at our two U.S. sites and two internationally recognized, cancer centers in Asia and Western Europe who recently joined the study. In 2022 we plan to report new clinical and preclinical evidence supporting the unique properties and therapeutic potential of fadraciclib. We believe that fadraciclib is emerging as the only transcriptional CDK inhibitor in development to have demonstrated single-agent activity and tolerable daily dosing by mouth in patients with solid tumors. If confirmed with additional data, fadraciclib may emerge as an important alternative for the treatment of advanced solid tumors in patients failing available therapies.

In addition, we expect imminent dosing of the first patient with oral CYC140, our novel, PLK1 inhibitor, in a Phase 1/2 study in advanced solid tumors. We are also enrolling patients with hematological malignancies in the dose escalation stage of a Phase 1/2 study of oral fadraciclib. We look forward to providing updates and further clinical and preclinical data from our ongoing programs as they become available."

Key Highlights

·12 patients with advanced solid tumors treated in four dose levels of 065-101 study of oral fadraciclib. Dose level 4 is 100mg given twice a day for 5 days for 3 weeks in a 4-week cycle. The proof-of-concept stage of this Phase 1/2 registration-directed study includes 7 histologically defined cohorts thought to be sensitive to the drug’s mechanism: breast, colorectal (including KRAS mutant), endometrial/ uterine, hepatobiliary, ovarian cancers and lymphomas. The study also includes a basket cohort which will enroll patients regardless of histology with biomarkers relevant to the drug’s mechanism, including MCL1, MYC and/or cyclin E amplified.

·Seoul National University Hospital, Seoul, South Korea and Vall d’Hebron University Hospital, Barcelona, Spain were added to the 065-101 oral fadraciclib study selected for their expertise with tumor types of interest.

·Two patients dosed in the 065-102 study of oral fadraciclib in patients with leukemia or myelodysplastic syndromes.

·Opened 140-101, a registration-directed, Phase 1/2 study of CYC140 in solid tumors, now recruiting. This Phase 1/2 registration-directed trial uses a streamlined design and will determine in dose escalation the recommended Phase 2 dose (RP2D) for single-agent oral CYC140. Once RP2D has been established, the trial will immediately enter into proof-of-concept, cohort stage, using a Simon 2-stage design. In this stage CYC140 will be administered to patients in up to seven mechanistically relevant cohorts plus a basket cohort which will enroll patients with biomarkers relevant to the drug’s mechanism.

·Preclinical studies are in progress to inform clinical development of fadraciclib and support selection of histologies for 140-101.

More information on our clinical trials can be found here.

Key Business Objectives for 2022

1H 2022

·Dose first patient with oral CYC140 in the 140-101 advanced solid tumor study
·Initial data from Phase 1 dose escalation of the 065-101 solid tumor study of oral fadraciclib

2H 2022

·Enter Phase 2 proof of concept stage in the 065-101 solid tumor study of oral fadraciclib in 8 cohorts (7 by histology and a basket cohort)
·Initial data from Phase 1 dose-escalation of the 065-102 leukemia study of oral fadraciclib

Financial Highlights

As of December 31, 2021, cash and cash equivalents totaled $36.6 million, compared to $33.4 million as of December 31, 2020. The increase of $3.2 million was primarily due to $21.7 million cash provided by financing activities, offset by $18.5 million net cash used in operating activities. The Company estimates that available cash resources will fund currently planned programs through mid-2023.

Research and development (R&D) expenses were $4.6 million and $15.5 million for the three months and year ended December 31, 2021, as compared to $1.4 million and $4.8 million for the same periods in 2020. R&D expenses relating to fadraciclib were $3.4 million and $11.1 million for the three months and year ended December 31, 2021, as compared to $1.1 million and $3.7 million for the same periods in 2020 due to clinical trial expenses for the evaluation of fadraciclib in Phase 1/2 studies and clinical supply manufacturing. Additionally, R&D expenses related to CYC140 were $1.1 million and $3.6 million for the three months and year ended December 31, 2021, as compared to $0.2 million and $0.6 million for the same periods in 2020 as preclinical evaluation and clinical trial supply manufacturing of CYC140 progressed.

General and administrative (G&A) expenses for the three months and year ended December 31, 2021, were $1.9 million and $7.5 million, compared to $1.8 million and $5.9 million for the same periods of the previous year due to increased legal and professional and personnel costs and a lease assignment. G&A expenses included non-cash stock compensation costs of $0.1 million and $0.8 million for the three months and full year ended December 31, 2021, compared to $0.1 million and $0.3 million for the same periods in 2020. United Kingdom research & development tax credits were $1.2 million and $3.8 million for the three months and year ended December 31, 2021, as compared to $0.4 million and $1.2 million for the same period in 2020 due to the increase in eligible R&D expenditure.

Net loss for the three months and year ended December 31, 2021, was $5.3 million and $18.9 million, compared to $2.8 million and $8.4 million for the same periods in 2020.

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.