On March 28, 2022 Aileron Therapeutics (Nasdaq: ALRN), a chemoprotection oncology company that aspires to make chemotherapy safer and thereby more effective to save more patients’ lives, reported business highlights and financial results for the fourth quarter and year ended December 31, 2021 (Press release, Aileron Therapeutics, MAR 28, 2022, View Source [SID1234611053]).

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"We’re incredibly proud of the progress we’ve made to date advancing our mission to develop a targeted drug that prevents chemotherapy-induced side effects in patients with p53-mutated cancer," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer of Aileron Therapeutics. "Given proof of concept of ALRN-6924’s ability to protect against chemotherapy-induced bone marrow toxicities and its potential to also protect against multiple other chemotherapy-induced toxicities, our vision is to redefine care for millions of cancer patients, regardless of the type of p53-mutated cancer they have or the type of chemotherapy they receive. We look forward to several anticipated catalysts in 2022 that could further propel us toward this vision."

Aileron is developing ALRN-6924 to protect healthy cells in patients with p53-mutated cancers to reduce or eliminate chemotherapy-induced side effects. Nearly 1 million patients each year are diagnosed with a p53-mutated cancer in the US alone, and Aileron is pioneering a precision medicine-based approach known as selective chemoprotection to exclusively treat patients with p53-mutated cancers who are receiving chemotherapy. ALRN-6924 is designed to selectively protect these patients’ healthy cells from chemotherapy without interfering with chemotherapy’s effects on cancer cells. The reduction or elimination of multiple chemotherapy-induced side effects is expected to enhance tolerability of chemotherapy, which is expected to result in fewer dose reductions and delays of chemotherapy, and thus expected to improve efficacy of chemotherapy.

2021 and Recent Highlights

NSCLC clinical trial start and blinded safety evaluation.
Initiated a Phase 1b randomized, double-blind, placebo-controlled clinical trial to evaluate ALRN-6924 to protect against chemotherapy-induced bone marrow toxicities in patients with p53-mutated NSCLC undergoing first-line carboplatin plus pemetrexed with or without immune checkpoint inhibitors.
Conducted a blinded safety evaluation of the first ten patients enrolled in the trial who completed the first cycle of treatment with ALRN-6924 and chemotherapy. The evaluation did not identify any safety concern, consistent with ALRN-6924’s previously demonstrated safety and tolerability profile.
The Phase 1b trial is anticipated to enroll 60 patients. Patients are randomized 1:1 to receive carboplatin/pemetrexed plus 0.3 mg/kg ALRN-6924 or placebo for at least four 21-day treatment cycles.
Upcoming breast cancer clinical trial. Announced plans to initiate a new clinical trial in 1H22 to evaluate ALRN-6924 against chemotherapy-induced bone marrow and other toxicities in patients with p53-mutated ER+/HER2- breast cancer treated with a doxorubicin + cyclophosphamide and docetaxel chemotherapy regimen, also known as ‘AC-D’. The Phase 1b trial is anticipated to enroll up to 30 patients in a parallel group design trial with a dose expansion cohort.

Small cell lung cancer (SCLC) clinical trial final data presentation. Presented final results from a completed Phase 1b trial in patients with p53-mutated SCLC receiving second-line topotecan. Following interim proof-of-concept data presented in October 2020 from this trial, the final results reinforced ALRN-6924’s ‘triple-play’ reduction in chemotherapy-induced neutropenia, thrombocytopenia and anemia.

Healthy volunteer study mechanism of action (MOA) data presentation. Presented initial data from company’s ongoing Phase 1 pharmacology study, which is evaluating ALRN-6924’s induction of p21-induced cell cycle arrest in healthy, normal bone marrow cells and other cell types in healthy volunteers receiving ALRN-6924. The presented data confirmed ALRN-6924’s novel p53 biomarker-driven MOA, as well as its pharmacodynamic effects, including time to onset, magnitude and duration.

Patent portfolio expansion. Aileron was issued seven new international patents and four U.S. patents, including a new patent for ALRN-6924 in China. The newly issued patents support Aileron’s robust intellectual property portfolio, which includes nearly 160 U.S. and foreign patents, with more than 40 additional applications in prosecution.
2022 Anticipated Milestones

Ongoing NSCLC Clinical Trial

2Q22: Announce results from an interim analysis of the first 20 patients enrolled in the NSCLC trial. The interim analysis will include an initial evaluation of the total number of completed treatment cycles free of hematological toxicity and free of chemotherapy or immunochemotherapy dose reductions, dose delays, use of growth factors and transfusions for the treatment arm compared to placebo. We expect these interim data will determine a refinement to the primary and secondary endpoints for the study.

4Q22: Announce topline results of full anticipated trial enrollment of 60 patients.
Planned Breast Cancer Clinical Trial

1H22: Initiate enrollment of patients with p53-mutated, ER+/HER2- breast cancer; provide more details on the planned neoadjuvant breast cancer trial design at time of trial initiation.
4Q22: Announce interim results from breast cancer trial.
Phase 1 Pharmacology Study in Healthy Volunteers

2H22: Report additional findings from healthy volunteer study.
CMC Activities

Advance validation studies for ALRN-6924 drug substance and drug product manufacturing processes to support a potential future NDA filing for ALRN-6924.
Fourth Quarter and Full Year 2021 Financial Results

Cash Position: As of December 31, 2021, cash, cash equivalents and investments were $45.9 million, compared to $13.8 million as of December 31, 2020. The company expects, based on its current operating plan, that its existing cash, cash equivalents and investments will fund operations into the fourth quarter of 2023.

Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2021 were $4.6 million, compared to $1.9 million for the fourth quarter of 2020. The increase in R&D expenses was primarily due to clinical activities related to our NSCLC trial and our healthy volunteer study and increased spend on CMC development for ALRN-6924 in 2021 as compared to 2020. R&D expenses for the full-year 2021 were $17.0 million, compared to $11.2 million for the prior year.

General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2021 were $2.3 million, compared to $2.3 million for the fourth quarter of 2020. G&A expenses for the full-year 2021 were $9.6 million, compared to $9.3 million for the prior year.

Net Loss: Net loss for the fourth quarter of 2021 was $6.8 million, compared to $4.9 million for the fourth quarter of 2020. Net loss for the full-year 2021 was $26.2 million, compared to a net loss of $21.2 million for the prior year. The basic and diluted net loss per share for the fourth quarter of 2021 was $0.08 compared to $0.12 for the fourth quarter of 2020. The basic and diluted net loss per share for the full-year 2021 was $0.29 compared to $0.61 for the full-year 2020.

On March 28, 2022 Labcorp (NYSE: LH), a leading global life sciences company, reported that it will release its financial results for the first quarter of 2022 before the market opens on Thursday, April 28, 2022 (Press release, LabCorp, MAR 28, 2022, View Source [SID1234611052]). The company will host a conference call and webcast beginning at 9 a.m. EDT that day to discuss the results. The earnings press release and accompanying financial information will be posted on the Labcorp Investor Relations website.

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Interested parties can access the conference call by dialing 1-877-825-4844 within the U.S. and Canada, or 1-631-813-4900 internationally, using the conference ID 2386657. In addition, a real-time webcast of the conference call will be available on the Labcorp Investor Relations website.

An audio replay of the conference call will be available from 1 p.m. EDT on April 28, 2022, until 11:30 p.m. EDT on May 12, 2022, by dialing 1-855-859-2056 within the U.S. and Canada, or 1-404-537-3406 internationally, using the conference ID 2386657. The webcast of the conference call will be archived and accessible through April 14, 2023, on the Labcorp Investor Relations website.

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.

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 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported financial results for the full year ended December 31, 2021 (Press release, Kinnate Biopharma, MAR 28, 2022, View Source [SID1234611049]).

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"The continuing advancement across our pipeline last year, including the first patient being dosed in our Phase 1 trial evaluating KIN-2787 in adult patients with BRAF-mutant advanced and metastatic tumors, positions the company to further deliver on several key upcoming milestones in 2022," said Nima Farzan, Chief Executive Officer of Kinnate Biopharma. "For KIN-2787, we are on target to report initial monotherapy data from the ongoing KN-8701 Phase 1 trial expected in the third quarter of 2022 and initial data from the combination of KIN-2787 with binimetinib in NRAS-mutant melanoma by year end 2022. Beyond KIN-2787, we were pleased to receive IND clearance for KIN-3248, a next-generation pan-FGFR inhibitor, from the FDA earlier this year and initiated the Phase 1 trial in the first quarter. Our goal of generating one IND filing per year from our Kinnate Discovery Engine remains an important focus for the company as we look to improve upon current targeted oncology outcomes."

Recent Business Highlights and Corporate Update:

KIN-2787, pan-RAF inhibitor

Announced that three abstracts highlighting data from KIN-2787 have been accepted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, to be held April 8-13, in New Orleans, Louisiana. KIN-2787 is an orally available small molecule pan-RAF inhibitor being developed for the treatment of patients with lung cancer, melanoma, and other solid tumors. The three abstracts include:
Occurrence of BRAF class II and III alterations is common across solid tumors and is associated with inferior clinical outcomes in NSCLC and melanoma (PAN# 4122);
Design and rationale of a first in human (FIH) Phase 1/1b study evaluating KIN-2787, a potent and highly selective pan-RAF inhibitor, in adult patients with BRAF- and NRAS-mutation positive solid tumors (PAN# CT248); and
Antitumor activity of KIN-2787, a next-generation pan-RAF inhibitor, in preclinical models of human RAF/RAS mutant melanoma (PAN# 2674).
Presented findings from a collaborative study with Tempus investigating the prevalence of Class II and Class III alterations among patients with BRAF-mutated solid tumors. These findings were presented as an e-Poster at the virtual European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Targeted Anticancer Therapies Congress (TAT). The meeting took place March 7-9, 2022.
Delivered an oral presentation of KIN-2787 preclinical data at the virtual IASLC 2022 Targeted Therapies of Lung Cancer meeting which took place February 22-26, 2022. In this study, KIN-2787 activity was assessed by suppression of downstream MAPK pathway signaling and subsequent cell growth inhibition across BRAF-altered and/or RAS-altered versus wild type panels of human non-small cell lung cancer (NSCLC) cell lines.
KIN-3248, FGFR Inhibitor

Announced the presentation of updates from preclinical studies evaluating its Fibroblast Growth Factor Receptor (FGFR) inhibitor candidate, KIN-3248, a next-generation pan-FGFR inhibitor being developed for intrahepatic cholangiocarcinoma (ICC) and urothelial carcinoma (UC) and other solid tumors. These findings were presented during a poster session at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium which took place January 20-22, 2022.
On January 18, 2022 announced that the U.S Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for KIN-3248. The Phase 1 trial initiated in the first quarter of 2022 and will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-cancer activity of KIN-3248 in FGFR inhibitor naïve and pretreated cancer patients with FGFR2 and/or FGFR3 gene alterations.
Full-Year 2021 Financial Results

Full year net loss for 2021 was $89.8 million, compared to $35.8 million in 2020.
Full year research and development expenses for 2021 were $67.2 million, compared to $29.2 million in 2020.
Full year general and administrative expenses for 2021 increased to $22.9 million, compared to $6.8 million in 2020.
As of December 31, 2021, the total of cash and cash equivalents and short-term investments was $324.9 million, exclusive of the joint venture’s cash.
Key Upcoming 2022 Milestone Targets
KIN-2787

Initial monotherapy data from the ongoing KN-8701 Phase 1 trial expected in the third quarter of 2022.
Initiation of the combination portion of KN-8701 to study KIN-2787 with binimetinib in NRAS-mutant melanoma expected in the first half of 2022 with initial data expected by year end 2022.
Initiation of a Phase 1 trial in Greater China by Kinnjiu expected in mid-2022.
KIN-3248

Initial data from ongoing KN-4802 Phase 1 trial expected in the second half of 2023.
Early Discovery Pipeline

Goal to generate one IND filing a year from the company’s Kinnate Discovery Engine.
Announcement of the company’s next pipeline target expected in the second half of 2022.