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 Ankyra Therapeutics, a company developing cancer therapies based on tumor localized immune potentiating agents, reported that the Board of Directors has appointed Howard L. Kaufman, MD as Chief Executive Officer effective March 22, 2022 (Press release, Ankyra Therapeutics, MAR 28, 2022, View Source [SID1234611065]). He will be the first CEO for the company and previously served as the Chief Medical Officer at Ankyra. Co-founder Tillman Gerngross, PhD will remain as Chairman of the Board at Ankyra Therapeutics.

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Dr. Kaufman has had numerous leadership roles in healthcare and biotechnology in his 20-year professional career. Among his many accomplishments include approvals of Amgen’s Talimogene laherparepvec, the first oncolytic virus approved by the FDA for the treatment of cancer, and EMD Serono’s avelumab, an anti-PD-L1 monoclonal antibody, the first drug approved by the FDA for the treatment of Merkel cell carcinoma. Prior to joining Ankyra as Chief Medical Officer, Dr. Kaufman served as Chief Medical Officer at Replimune, Inc. and Head of Research & Development at Immuneering Corp. Prior to joining industry he had an exemplary academic career and was the Associate Director of the Herbert Irving Cancer Center at Columbia University in New York City, Associate Dean and Cancer Center Director at Rush University in Chicago and was a tenured Professor at Rutgers University in New Jersey. He has also served as President of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) and has published over 500 peer-reviewed manuscripts and book chapters. He currently holds clinical appointments at the Massachusetts General Hospital and Massachusetts Eye & Ear Infirmary in Boston and has an academic appointment at Harvard Medical School. Dr. Kaufman has been driven by his passion to find new treatments for patients with cancer and has enjoyed mentoring early career physicians and scientists to focus on cancer immunotherapy.

"I am honored to be leading Ankyra at this exciting time in their development," Dr. Kaufman said. He went on to add that, "The anchored immunotherapy platform being developed at Ankyra provides a novel, yet simple, solution for delivering therapeutically effective doses of immunotherapy agents to cancers while avoiding systemic toxicity. Ankyra has assembled one of the most experienced and productive teams in the business and is well positioned to benefit from the many academic collaborations already established." Kaufman also went on to say that, "We will place a high priority on getting our lead drug into the clinic while also broadening the Ankyra pipeline in order to extend the impact of anchored immunotherapy to as many cancer patients as possible."

"Dr. Kaufman is a well-respected expert in immunotherapy, and in his CMO role at Ankyra, he has positioned the company for rapid translation of our lead compound into the clinic. Since joining Ankyra, he has also established several key academic and pharmaceutical partnerships that have accelerated our development efforts," stated Dr. Tillman Gerngross, Co-founder, and Chairman of the Board of Directors at Ankyra Therapeutics.

On March 28, 2022 Vyant Bio, Inc. ("Vyant Bio", "Company") (Nasdaq: VYNT), is an innovative biotechnology company reinventing drug discovery for complex neurodevelopmental and neurodegenerative disorders (Press release, Vyant Bio, MAR 28, 2022, View Source [SID1234611128]). The Company’s central nervous system ("CNS") drug discovery platform combines human-derived organoid models of brain disease, scaled biology, and machine learning . Today, Vyant Bio reported that an investor conference call and webcast will be hosted on Wednesday, March 30, 2022.

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Jay Roberts, Chief Executive Officer, Andy LaFrence, Chief Financial Officer and Robert T. Fremeau, PhD, Chief Scientific Officer of Vyant Bio will discuss the Year-End 2021 results. Management will provide additional corporate updates as well as answer questions. Please also visit the Investors section of the Vyant Bio web site for details on how to participate.

Event: Investor Conference Call and Webcast for the Fourth Quarter and Year-End 2021
Date: Wednesday, March 30, 2022
Time: 8:30am ET
Dial In: Toll Free: 1.877.545.0523 Conference ID: 449263
Webcast: View Source

The live event will be recorded and available for replay. The conference call and webcast details are also included inside the Investors section of the Vyant Bio corporate website at www.vyantbio.com.

On March 28, 2022 Ginkgo Bioworks Holdings, Inc. (NYSE: DNA, "Ginkgo"), the leading horizontal platform for cell programming, reported its results for the fourth quarter and year ended December 31, 2021 (Press release, Ginkgo Bioworks, MAR 28, 2022, View Source [SID1234611239]). The update, including a webcast slide presentation with additional details on the fourth quarter and supplemental financial information, will be available at investors.ginkgobioworks.com.

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"The current market environment provides both challenges and opportunities, but I’ve never been more excited about Ginkgo’s future. We met or exceeded each of our publicly disclosed metrics in 2021, some significantly, and we believe we are in the strongest position that we’ve ever been in as a company," said Jason Kelly, co-founder and CEO of Ginkgo. "I couldn’t be prouder of our team and the way they have shown up to build our platform and deliver cell programs for our partners over the past year. Some of the greatest challenges of our generation – including climate change and food security – are fundamentally biological. Ginkgo is unique in our relative scale and our focus on the development of broad-based horizontal technologies to make biology easier to engineer – and on humankind’s ability to do so responsibly."

Recent Business Highlights & Strategic Positioning
Added 10 new Cell Programs to the Foundry platform in Q4 2021, for a total of 31 new programs in the full year, representing 72% growth over 2020.
Significantly exceeded outlook for both Foundry and Biosecurity revenue with full year revenue reaching $314 million, representing growth of 309% over 2020.
Continued to drive "Knight’s Law" Foundry scaling as we were able to increase our deployment of new technologies, including multiplexed strain tests.
Biosecurity offering, Concentric by Ginkgo, grew rapidly in Q4, reaching $201 million in revenue for the full year, and is seeing signs of longer-term opportunities.
Expanded offering with a lab network that has empowered communities with COVID-19 monitoring programs across the United States.
Since inception, Concentric has tested more than 7,200,000 samples, and now serves over 280,000 individuals per week.
Well-positioned to play a role in response to longer-term needs, including endemic COVID-19, broader pandemic preparedness, and biodefense.
Announced two tuck-in acquisitions year-to-date in 2022:
Project Beacon: a Boston-based social benefit organization focused on increasing the capacity, availability, accessibility and affordability of COVID-19 testing.
FGen: a Swiss company specializing in ultra-high-throughput strain development and optimization.
Fourth Quarter 2021 Financial Highlights
Fourth quarter 2021 Total revenue of $148 million, up from $32 million in the comparable prior year period, an increase of 363%.
Fourth quarter 2021 Foundry revenue of $34 million, up from $16 million in the comparable prior year period, an increase of 108%.
Fourth quarter 2021 Biosecurity revenue of $114 million with gross profit margin of 42%.
Fourth quarter 2021 Loss from operations of $(1.7) billion, inclusive of "catch-up" GAAP stock-based compensation expense of $1.7 billion, compared to Loss from operations of $(56) million in the comparable prior year period.
Fourth quarter 2021 Adjusted EBITDA of $1 million, improved from $(51) million in the comparable prior year period.
Cash and cash equivalents balance as of the end of the fourth quarter of over $1.5 billion puts Ginkgo in a strong financial position to pursue its strategic objectives.
Full Year 2021 Financial Highlights
Full year 2021 Total revenue of $314 million, up from $77 million in the prior year, an increase of 309%.
Full year 2021 Foundry revenue of $113 million, up from $59 million in the prior year, an increase of 91%.
Full year 2021 Biosecurity revenue of $201 million compares to our full year 2021 outlook of $110 million.
Full year 2021 Loss from operations of $(1.8) billion, inclusive of "catch-up" stock-based compensation expense of $1.7 billion, compared to $(137) million in the prior year.
Full year 2021 Adjusted EBITDA of $(106) million, improved from $(121) million in the prior year.
2022 Guidance
Ginkgo expects to add 60 new Cell Programs to the Foundry platform in 2022.
Ginkgo expects Total revenue of $325 to $340 million in 2022.
Ginkgo expects Foundry revenue of $165 to $180 million in 2022.
While Biosecurity remains an uncertain business, Ginkgo is committed to investing in the space and expects Biosecurity revenue in 2022 of at least $160 million.
Stock Based Compensation
In the fourth quarter, Ginkgo recognized $1.7 billion of stock-based compensation expense. Prior to becoming a public company in September 2021, Ginkgo granted restricted stock units ("RSUs") with both a service-based vesting condition and a performance-based vesting condition, defined as a change in control or an initial public offering (both as defined in the underlying award agreement). Ginkgo historically did not recognize any stock-based compensation expense associated with these awards due to the performance-based vesting condition.
As previously disclosed, on November 17, 2021 the board of directors modified the vesting terms of RSUs, such that Ginkgo’s business combination with Soaring Eagle Acquisition Corp. was deemed to have met the performance condition for vesting. This was accounted for as a modification and resulted in a catch-up adjustment of approximately $1.5 billion of incremental stock-based compensation expense in the fourth quarter of 2021 (calculated based on the number of RSUs impacted, which had been granted since 2015, at the share price of $13.59 on November 17, 2021). Stock-based compensation expense also increased by $173.5 million related to RSU earnout shares ("Earnout RSUs") which were also subject to the same performance condition as the underlying RSUs.
As of December 31, 2021, there was $2.2 billion of unrecognized stock-based compensation expense related to the above catch-up adjustment for those RSUs and Earnout RSUs that had not yet fully met the service-based vesting condition as of December 31, 2021. This amount will be recognized over a weighted-average period of 1.6 years.
Conference Call Details
Ginkgo will host a videoconference today, Monday, March 28, 2022, beginning at 4:30 p.m. ET. The presentation will include an overview of the fourth quarter and full year financial performance, recent business updates, a discussion on Ginkgo’s outlook, as well as a moderated question and answer session.

To ask a question ahead of the presentation, please submit your questions to @Ginkgo on Twitter (hashtag #GinkgoResults) or by sending an e-mail to [email protected].

A webcast link is available on Ginkgo’s Investor Relations website and a replay will be made available following the presentation.

Ginkgo Investor Website: View Source

Webinar ID: 961 0791 2467
If you experience technical difficulties with any of these dial-ins or if you need international dial-in numbers, please visit our web site at View Source for updated dial-in information.

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.