On August 9, 2022 AbCellera (Nasdaq: ABCL), a technology company with a centralized operating system for next-generation antibody discovery, reported financial results for the second quarter of 2022 (Press release, AbCellera, AUG 9, 2022, View Source [SID1234617962]). All financial information in this press release is reported in U.S. dollars, unless otherwise indicated.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We have further strengthened our balance sheet as we execute on our strategy, extending our competitive advantage in antibody discovery and creating value through partnerships," said Carl Hansen, Ph.D., CEO and President of AbCellera. "We continue to invest in technology development, including advancements in our CD3 bispecific platform for creating optimal T-cell-engager therapies for cancer, which we believe will create significant value for patients, our partners, and our shareholders."

Q2 2022 Business Summary

Earned $46 million in total revenue.
Incurred net loss of $7 million, compared to a net loss of $2 million in Q2 2021.
Added six programs under contract with two new partners, resulting in a cumulative total of 164 programs under contract with 38 different partners.
Started discovery on four programs, bringing the cumulative number of program starts to 88.
Continuing to report six molecules cumulatively advanced to the clinic.
Key Business Metrics

AbCellera added six discovery programs in Q2 to reach a cumulative total of 164 discovery programs as of June 30, 2022 (up from 138 on June 30, 2021), that are either completed, in progress, or under contract with 38 different partners (up from 33 on June 30, 2021). AbCellera started discovery on an additional four programs in Q2 to reach a cumulative total of 88 program starts (up from 60 on June 30, 2021). AbCellera’s partners have advanced a cumulative total of six molecules into the clinic.

Discussion of Q2 2022 Financial Results

Revenue – Total revenue was $45.9 million, compared to $27.6 million in Q2 2021. Royalties associated with bebtelovimab were $33.2 million. The partnership business produced research fees of $12.5 million, compared to $5.2 million in Q2 2021. Licensing revenue was $0.1 million.
Research & Development (R&D) Expenses – R&D expenses were $26.7 million, compared to $15.0 million in Q2 2021, reflecting continuing investments in the capacity and capabilities of AbCellera’s discovery and development platform.
Sales & Marketing (S&M) Expenses – S&M expenses were $3.1 million, compared to $1.3 million in Q2 2021.
General & Administrative (G&A) Expenses – G&A expenses were $14.4 million, compared to $11.2 million in Q2 2021, with the increase driven by investments to support the growth of the company.
Net Loss – Net loss was $6.8 million, or ($0.02) per share on both a basic and diluted basis compared to a net loss of $2.3 million, or ($0.01) per share on a basic and diluted basis in Q2 2021.
Liquidity – $1,022 million of cash, cash equivalents, and marketable securities.
Conference Call and Webcast

AbCellera will host a conference call and live webcast to discuss these results today at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time).

The live webcast of the earnings conference call can be accessed on the Events and Presentations section of AbCellera’s Investor Relations website. A replay of the webcast will be available through the same link following the conference call.

On August 2, 2022 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported financial results for the quarter ended June 30, 2022 and provided a corporate update (Press release, Syros Pharmaceuticals, AUG 9, 2022, View Source [SID1234617961]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are entering the second half of the year in a position of strength with multiple data readouts expected over the next 18 months and, following the anticipated closing of our previously announced merger with TYME Technologies and concurrent PIPE financing, we expect to have a robust balance sheet," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "The gross proceeds of approximately $190 million from these transactions, together with the amendment to our existing loan facility, are expected to extend our cash runway into 2025, at least one year beyond expected pivotal data from our ongoing SELECT-MDS-1 trial."

Dr. Simonian continued, "Today, we reported promising preliminary data from our ongoing dose confirmation trial of SY-2101, our novel oral form of arsenic trioxide. Based on the pharmacokinetic data available to date, SY-2101 achieved exposures comparable to IV arsenic trioxide and demonstrated high oral bioavailability. The totality of data with our oral arsenic trioxide continues to support a favorable safety and tolerability profile, giving us further confidence that SY-2101 has the potential to replace the standard-of-care for acute promyelocytic leukemia patients. Based on recent feedback received from the EMA, Syros plans to conduct a singular registration trial for SY-2101 that could support approval in both the United States and the European Union."

UPCOMING MILESTONES

Tamibarotene: Oral RARα agonist

Higher-Risk Myelodysplastic Syndrome (HR-MDS)

On track to report pivotal data from the SELECT-MDS-1 trial in newly diagnosed RARA-positive patients with HR-MDS in the fourth quarter of 2023 or the first quarter of 2024, with a potential new drug application (NDA) filing expected in 2024.
Acute Myelodysplastic Syndrome (AML)

On track to report safety and clinical activity data from the safety lead-in portion of the ongoing SELECT-AML-1 Phase 2 trial in RARA-positive patients with newly diagnosed unfit AML in the second half of 2022.
Expect to initiate the randomized portion of the SELECT-AML-1 Phase 2 trial in an additional eighty patients evaluating the triplet regimen of tamibarotene, venetoclax and azacitidine compared to venetoclax and azacitidine with data expected in 2023 or 2024.
SY-2101: Oral arsenic trioxide (ATO)

Expect to initiate the Phase 3 trial of SY-2101 for the treatment of acute promyelocytic leukemia (APL) in the second half of 2023.
SY-5609: Oral selective CDK7 inhibitor

On track to report safety and clinical activity data from the safety lead-in portion of the ongoing Phase 1 trial evaluating SY-5609 in combination with chemotherapy in relapsed/refractory metastatic pancreatic cancer in the second half of 2022.
RECENT PIPELINE HIGHLIGHTS

Today, Syros announced promising preliminary data from newly diagnosed APL patients enrolled to date in the dose confirmation trial of SY-2101. This is the first cross-over data directly comparing the pharmacokinetics (PK) of SY-2101 to the approved IV dose ATO. SY-2101 administered at 15 mg achieved comparable PK (AUC and Cmax) exposures to IV ATO administered at 0.15 mg/kg. Additionally, SY-2101 showed high oral bioavailability of approximately 80% and continues to support a favorable tolerability profile.
In July, Syros received European Medicines Agency (EMA)/ Committee for Medicinal Products for Human Use (CHMP) scientific advice on the SY-2101 Phase 3 trial design in front line APL. The feedback informs Syros’ plan for a singular registration trial for SY-2101 that could support approval in both the United States (US) and the European Union (EU).
In July, the EMA issued a positive opinion on the Company’s application for orphan drug designation for tamibarotene for the treatment of MDS. The EMA’s orphan designation is available to companies developing treatments for life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 persons in the EU. Medicines that meet the EMA’s orphan designation criteria qualify for financial and regulatory incentives, including a 10-year period of marketing exclusivity in the EU after product approval, protocol assistance from the EMA at reduced fees during the product development phase and access to centralized marketing authorization.
In June, Syros announced that based on results from over 175 MDS patients, the company now estimates that approximately 50% of patients with MDS are RARA-positive, as compared to the previously estimated 30%.
Roche is now actively enrolling patients in the arm of its ongoing Phase 1/1b INTRINISIC trial evaluating SY-5609 in combination with atezolizumab, its PD-L1 inhibitor, in BRAF-mutant colorectal cancer patients. Under the terms of Syros’ agreement with Roche, Roche is the sponsor of the trial and Syros is supplying SY-5609.
In July, Syros advanced its oral, potent, and selective CDK12 inhibitor, SY-12882, to development candidate. Preclinical data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting demonstrated that selective CDK12 inhibition resulted in strong anti-tumor activity as a single agent as well as in combination with a DNA damaging agent and in combination with a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor in models of breast, lung, and ovarian cancer.
CORPORATE

In July, Syros announced that it plans to raise approximately $190 million through a merger with TYME Technologies and an oversubscribed private investment in public equity (PIPE) financing. The $130M PIPE was led by a life sciences-focused investment fund, with participation from new and existing investors, including Syros co-founder and founding investor Flagship Pioneering, as well as Avidity Partners, Deep Track Capital, Bain Capital Life Sciences, Invus, Samsara BioCapital, Adage Capital Partners LP, Ally Bridge Group and Cowen Healthcare Investments. The transactions are expected to close concurrently with each other in the second half of 2022, subject to approval by the stockholders of Syros and TYME and the satisfaction of other customary closing conditions.
Concurrently, Syros amended its senior secured loan facility with Oxford Finance LLC (Oxford) to, subject to certain conditions, extend the interest-only payment period to March 1, 2024 (and, upon the achievement of certain milestones, September 1, 2024), and extend the maturity date to February 1, 2026 (and, upon the achievement of certain milestones, August 1, 2026).
Also in July, Syros announced that it is seeking partnerships for all its wholly owned discovery programs. The Company will continue to execute on its existing collaborations with Incyte Corporation (Incyte) and Global Blood Therapeutics (GBT), for which its research efforts are fully funded, as provided in each agreement.
Second Quarter 2022 Financial Results

Revenues were $6.3 million for the second quarter of 2022, consisting of $5.7 million in revenue recognized under Syros’ collaboration with GBT and $0.6 million recognized under its collaboration with Incyte. Syros recognized $5.2 million in revenue in the second quarter of 2021, consisting of $3.3 million in revenue recognized under its collaboration with GBT and $1.9 million recognized under its collaboration with Incyte.
Research and development expenses were $33.1 million for the second quarter of 2022, as compared to $25.8 million for the second quarter of 2021. This increase was primarily due to the increase in costs associated with the continued advancement of our clinical and preclinical programs and employee-related expenses.
General and administrative (G&A) expenses were $6.9 million for the second quarter of 2022, as compared to $5.5 million for the second quarter of 2021. This increase was primarily due to an increase in employee-related expenses.
For the second quarter of 2022, Syros reported a net loss of $34.5 million, or $0.54 per share, compared to a net loss of $22.5 million, or $0.36 per share, for the same period in 2021.
Cash and Financial Guidance

Cash, cash equivalents and marketable securities as of June 30, 2022 were $86.3 million, as compared with $143.4 million on December 31, 2021. Based on Syros’s current operating plan and without giving effect to the merger with TYME, the PIPE financing and the loan amendment with Oxford, the completion of which cannot be assured, Syros anticipates that its cash, cash equivalents and marketable securities of $86.3 million as of June 30, 2022 will allow it to meet its liquidity requirements into the second quarter of 2023.

If Syros completes the merger with TYME and the PIPE financing and gives effect to certain provisions of the loan amendment with Oxford related to such closings (which is expected to occur in the second half of 2022), Syros anticipates having approximately $240 million in cash and other capital resources (after transaction expenses), which it believes will be sufficient to fund its planned operating expenses and capital expenditure requirements into 2025.

Conference Call and Webcast

Syros will host a conference call today at 8:30 a.m. ET to discuss these second quarter 2022 financial results and provide a corporate update.

To access the live conference call, please dial (833) 636-1323 (domestic) or (412) 902-4279 (international) and refer to the "Syros Pharmaceuticals Conference Call." A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

On August 9, 2022 Cellworks Group, Inc., a world leader in Personalized Medicine in the key therapeutic areas of Oncology and Immunology, reported results from the myCare-203A study, which demonstrate that the Cellworks Biosimulation Platform and Singula Therapy Response Index (TRI) was strongly predictive of Overall Survival (OS) for non-small cell lung cancer (NSCLC) patients and can provide personalized therapy decision guidance (Press release, Cellworks, AUG 9, 2022, View Source [SID1234617960]). In the study, Singula Therapy Response Index (TRI) provided patient-specific scores that demonstrated predictive value of OS beyond NCCN-guideline genomic biomarkers, physician-prescribed treatments and standard clinical factors such as the patient’s age and sex.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The results from the myCare-203A clinical study were featured in a poster presentation at the IASLC 2022 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer and held in Vienna, Austria from August 6-9, 2022.

"The current population-based cancer therapy guidelines do not consider the full biological complexity of an individual patient’s disease and therefore may limit the patient’s duration of therapy response and overall effectiveness of the treatment," said Dr. Mark Klein, Staff Physician, Hematology/Oncology Section, Minneapolis VA; Associate Professor, Division of Hematology, Oncology and Transplantation, University of Minnesota; and Co-Principal Investigator of the myCare-203A clinical study. "In contrast to population-based therapy guidelines, the Cellworks Biosimulation Platform produces personalized therapy predictions for each NSCLC patient based on a patient-specific multi-omic disease model. The myCare-203A study found that the personalized approach of Cellworks Singula TRI produces a more precise therapeutic decision guide for patients with NSCLC."

"There are multiple approved drugs for treating NSCLC, which makes selecting the most efficacious treatment for each patient more complicated," said Dr. Apar Kishor Ganti, Staff Physician, VA Nebraska Western Iowa Health Care System; Professor in the Department of Internal Medicine, Division of Oncology/Hematology, at the University of Nebraska Medical Center; and Co-Principal Investigator of the myCare-203A clinical study. "The myCare-203A study shows us that the Cellworks Biosimulation Platform and Singula TRI can streamline the treatment decision-making process and improve NSCLC patient outcomes through personalized therapy response predictions."

The Cellworks Biosimulation Platform simulates how a patient’s personalized genomic disease model will respond to therapies prior to treatment. The platform is powered by Cellworks groundbreaking Computational Omics Biology Model (CBM), a network of 7,000+ human genes, 30,000+ molecular species and 100+ signaling pathways. As part of the biosimulation process, personalized disease models are created for each patient using their cytogenetic and molecular data as input to the Cellworks CBM. The Cellworks platform analyzes the impact of specific therapies on the patient’s personalized disease model and generates a Singula biosimulation report with Therapy Response Index (TRI) scores from 0 to 100 that predict low to high therapeutic benefit.

myCare-203A Clinical Study

Background
In this study, the Cellworks Biosimulation Platform and Computational Omics Biology Model (CBM) was used to prospectively generate Singula Therapy Response Index (TRI) scores for a retrospective cohort of 453 NSCLC patients aged 39-87 (22 female, 431 male) from Veterans Affairs facilities, who were treated with physician-prescribed therapies.

Methods
Cellworks Singula TRI scores were generated for physician-prescribed therapies and 109 alternate therapies for each patient, enabling selection of optimal therapies with estimates of improvements in median OS compared to standard care. Multivariate Cox Proportional Hazards regression models were used to test the hypothesis that Cellworks Singula TRI provides predictive value of OS above and beyond physician-prescribed treatment, NCCN-guideline genomic biomarkers, patient age and patient sex.

Results and Conclusions
Multivariate analyses demonstrated that Cellworks Singula TRI is a significant predictor of OS and provided predictive value of OS above and beyond physician-prescribed treatment, NCCN-guideline genomic biomarkers, patient age and patient sex. These results show that physicians can use Cellworks Singula TRI scores to more precisely guide therapeutic decisions for individual patients with NSCLC.

On August 9, 2022 BostonGene reported the online publication of the manuscript, "Precise reconstruction of the tumor microenvironment using bulk RNA-seq and a unique machine learning algorithm trained on artificial transcriptomes" in Cancer Cell, a premier peer-reviewed scientific journal that publishes high impact results in cancer research and oncology (Press release, BostonGene, AUG 9, 2022, View Source [SID1234617959]). The study demonstrated the ability of the BostonGene-developed unique and robust machine learning (ML) algorithm named Kassandra to digitally reconstruct the tissue tumor microenvironment (TME) and blood cellular composition, identifying over 50 unique cell populations in total from RNA-seq derived from both archival and fresh tissues. These results indicate that cellular deconvolution can be utilized in future clinical applications to predict blood and tissue microenvironment composition, a critical factor in cancer pathogenesis, clinical outcome, and therapeutic resistance.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Kassandra was trained on a broad collection of > 9,400 tissue and blood-sorted cell RNA profiles incorporated into millions of artificial transcriptomes for this research study. To increase the stability and robustness of BostonGene’s decision-tree ML deconvolution algorithm, bioinformatic correction for technical and biological variability, aberrant cancer cell expression inclusion, and accurate quantification and normalization of transcript expression were applied. Results of the study showed that Kassandra recognizes 51 unique subpopulations and accurately deconvolves less well-characterized stromal and immune elements of prospectively collected lung and kidney cancer tumors. Kassandra-based TME reconstruction found the presence of PD1-positive CD8+ T cells strongly correlates with immunotherapy response and PD-L1 protein levels detected by immunohistochemistry, the established immunotherapy response biomarker, indicating that in the future RNA-seq-based cellular deconvolution could support oncology clinical decision-making.

"Our findings demonstrate the importance of cellular deconvolution based on RNA-seq to accurately understand the composition and activity of the tumor and the microenvironment to improve treatment outcomes," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "We look forward to further developing the Kassandra algorithm and showing its clinical applicability in precision oncology.

On August 9, 2022 Fore Biotherapeutics, a precision oncology company developing treatments for patients with genetically defined cancers whose current treatment options are limited, reported that data from the ongoing Phase 1/2a study of lead asset, FORE8394, will be presented in the Developmental Therapeutics poster session at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (ESMO) (Free ESMO Whitepaper) taking place in Paris, France, September 9-13, 2022 (Press release, Fore Biotherapeutics, AUG 9, 2022, View Source [SID1234617958]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Phase 1/2a open-label study is assessing FORE8394, a next-generation BRAF inhibitor, in patients with advanced solid and CNS tumors with activating BRAF alterations. The poster presentation will report interim analysis in adults (≥18 years) with V600+ advanced solid & central nervous system tumors, including patients who have not previously received BRAF targeted treatment. FORE8394 is a novel, differentiated BRAF inhibitor that uniquely targets Class 1 (V600) and Class 2 alterations, including fusions, and does not induce paradoxical activation of the RAF/MEK/ERK pathway, a limitation of the current standard of care.

Details for the presentation are as follows:

Title: Efficacy of BRAF Inhibitor FORE8394 in BRAF V600+ Patients
Abstract #: 2098
Presentation #: 466P
Presenter: Eric J. Sherman, Memorial Sloan Kettering Cancer Center
Date: Monday, September 12, 2022
Time: 12:00 -13:00 CEST

About FORE8394
FORE8394 is an investigational, novel, small-molecule, next-generation, orally available selective inhibitor of mutated BRAF. It was designed to target a wide range of BRAF mutations while sparing wild type forms of RAF. Preclinical studies and clinical trials have shown that its unique mechanism of action effectively inhibits not only the constitutively active BRAFV600 monomers targeted by first-generation RAF inhibitors, but also disrupts constitutively active dimeric BRAF class II mutants, fusions, splice variants and others. Unlike first-generation RAF inhibitors, FORE8394 does not induce paradoxical activation of the RAF/MEK/ERK pathway. As a "paradox breaker," FORE8394 could therefore treat acquired resistance to current RAF inhibitors, and, more generally, yield improved safety and more durable efficacy than first-generation RAF inhibitors