On May 7, 2021 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that senior management will present at the upcoming Bank of America Health Care Conference on Wednesday, May 12, 2021 at 1:15 p.m. EST / 10:15 a.m. PST (Press release, Coherus Biosciences, MAY 7, 2021, View Source [SID1234579456]).

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The audio portion of the Company presentation will be available on the investors page of the Coherus BioSciences website at View Source

On May 7, 2021 Celyad Oncology SA (Euronext & Nasdaq: CYAD) (the "Company"), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, reported an update on its financial results and recent business developments for the fiscal quarter ended March 31, 2021 (Press release, Celyad, MAY 7, 2021, View Source [SID1234579455]).

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"We have entered 2021 with ever-increasing enthusiasm around the progress of our programs," commented Filippo Petti, Chief Executive Officer of Celyad Oncology. "Our lead shRNA-based allogeneic candidate, CYAD-211, which is currently being evaluated in the Phase 1 IMMUNICY-1 trial for the treatment of multiple myeloma, has shown no safety concerns nor evidence of Graft-versus-Host Disease (GvHD) at dose level 1. We look forward to announcing additional proof-of-concept data from this trial by the end of second quarter of 2021. In addition, we have continued to enroll patients in the alloSHRINK expansion trial for CYAD-101 and will turn our attention to the KEYNOTE-B79 trial. Lastly, we are planning an R&D day for this summer that will provide an opportunity for our broader team to offer an in-depth overview of our clinical programs and strategy for advancing our next-generation shRNA platform and allogeneic pipeline."

Recent Highlights

Appointment of Dr. Charles Morris as Chief Medical Officer to lead and provide strategic direction for Celyad Oncology’s medical, regulatory, and clinical development activities.
Appointment of Marina Udier, Ph.D. to Board of Directors
Announced a committed equity purchase agreement for up to $40 million in American Depositary Shares (ADSs) with Lincoln Park Capital Fund, LLC ("LPC")
First Quarter 2021 Financial Review

As of March 31, 2021, the Company had cash and cash equivalents of €12.2 million ($14.3 million). Net cash burn during the first quarter of 2021 amounted to €5.1 million ($5.9 million), in line with expectations. In April 2021, the Company raised proceeds of €3.3 million ($4.0 million) from the sale of ADSs to LPC. The Company confirms its previous guidance that its existing cash and cash equivalents combined with the remaining access to the equity purchase agreement established with LPC should be sufficient, based on the current scope of activities, to fund operating expenses and capital expenditure requirements until mid-2022.

Update on Clinical Programs

CYAD-211 – Allogeneic shRNA-based, anti-BCMA CAR T for r/r MM

CYAD-211 is an investigational, shRNA-based allogeneic CAR T candidate engineered to co-express a BCMA-targeting chimeric antigen receptor and a single shRNA, which interferes with the expression of the CD3ζ component of the T-cell receptor (TCR) complex. The Company is currently conducting the first-in-human, open-label, dose-escalation Phase 1 IMMUNICY-1 trial to evaluate the safety and efficacy of a single infusion of CYAD-211 following preconditioning chemotherapy cyclophosphamide and fludarabine in patients with r/r MM. The trial seeks to determine the recommended dose of CYAD-211 for the treatment of patients with r/r MM for further development as well as to establish proof-of-concept that single shRNA-mediated knockdown can generate allogeneic CAR T cells in humans without inducing GvHD. In March, the Company announced that no safety concerns nor evidence of GvHD had been reported in the first three patients treated at dose level 1 (30×106 cells per infusion) of CYAD-211 in the IMMUNICY-1 trial. In first quarter 2021, the Company initiated enrollment in dose level 2 (100×106 cells per infusion). The Company expects to announce additional proof-of-concept data from the IMMUNICY-1 trial by the end of the second quarter of 2021.

CYAD-101 – Allogeneic TIM-based NKG2D CAR T for mCRC

The Company’s first-in-class, non-gene edited clinical candidate, CYAD-101, which co-expresses the NKG2D receptor and the novel inhibitory peptide TCR Inhibitory Molecule (TIM), is currently in the expansion segment of the alloSHRINK Phase 1 trial for the treatment of advanced mCRC. To the Company’s knowledge, CYAD-101 is the first investigational allogeneic CAR T candidate to generate evidence of clinical activity for the treatment of a solid tumor indication.

Phase 1 alloSHRINK trial is ongoing, in which the Company is evaluating CYAD-101 following FOLFIRI (combination of 5-fluorouracil, leucovorin and irinotecan) preconditioning chemotherapy in refractory mCRC patients, at the recommended dose of one billion cells per infusion. The Company expects to announce preliminary data from the expansion cohort of the trial in mid-2021.
Celyad Oncology will also conduct the Phase 1b KEYNOTE-B79 clinical trial, which will evaluate Celyad Oncology’s investigational non-gene edited allogeneic CAR T candidate, CYAD-101, following FOLFIRI chemotherapy, with MSD’s anti-PD­1 therapy, KEYTRUDA (pembrolizumab) in refractory metastatic colorectal cancer (mCRC) patients with microsatellite stable (MSS) / mismatch-repair proficient (pMMR) disease. The Phase 1b KEYNOTE-B79 trial is expected to be initiated during first half of 2021.
CYAD-02 – Autologous NKG2D receptor-based CAR T for relapsed/refractory acute myeloid leukemia (r/r AML) and myelodysplastic syndromes (MDS)

Enrollment is ongoing in dose level 3 of the Phase 1 CYCLE-1 trial for the next-generation, autologous NKG2D receptor-based CAR T candidate CYAD-02. The dose-escalation Phase 1 CYCLE-1 trial is evaluating the safety and clinical activity of CYAD-02 following preconditioning chemotherapy in patients with r/r AML and MDS. To date, treatment with CYAD-02 has been generally well-tolerated. Of seven patients evaluable for clinical activity, five patients demonstrated anti-leukemic activity (at least 50% bone marrow blasts decrease), including a very-high risk MDS patient treated at dose level 3 who achieved a marrow complete response.

Next-generation shRNA Multiplex Platform

In 2020, the Company began developing a proprietary shRNA platform utilizing a novel framework to optimize and expand the expression of multiple shRNAs with our All-in-One vector approach. The Company’s novel framework has the capability to knockdown or silence up to six genes simultaneously, while providing several key advantages beyond the Company’s first-generation approach. The Company believes its next-generation shRNA multiplex platform will form the backbone for future allogeneic CAR T candidates, including several programs which are in the discovery phase of development. Our next-generation shRNA platform does not incorporate any of the Horizon Discovery technology.

Upcoming Milestones

Additional proof-of-concept data from the initial dose cohorts of the Phase 1 IMMUNICY-1 trial of CYAD-211 for r/r MM are expected by the end of second quarter of 2021.
Preliminary data from the expansion segment of the alloSHRINK trial evaluating CYAD-101 following FOLFIRI preconditioning chemotherapy in refractory mCRC patients are expected in mid-2021.
Initiation of the Phase 1b KEYNOTE-B79 trial evaluating CYAD-101 with KEYTRUDA in mCRC patients with MSS/pMMR disease is anticipated in the first half of 2021.
Additional data from dose level 3 of Phase 1 CYCLE-1 trial of CYAD-02 for r/r AML and MDS are anticipated in the first half of 2021.
Financial Calendar

First Half 2021 Financial Results …………………… August 4, 2021
Third Quarter 2021 Financial Results ……………… November 10, 2021

On May 7, 2021 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, reported that it will report fiscal 2021 second quarter financial results after market close on Thursday, May 13, 2021 (Press release, Applied DNA Sciences, MAY 7, 2021, View Source [SID1234579454]). The Company’s management will discuss the results during a conference call and simultaneous webcast at 4:30 p.m. ET that same day. Presentation slides will also be posted to the ‘IR Calendar’ section of the Company’s corporate website and embedded into the live webcast.

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Conference Call and Webcast Information – Replay
A telephonic replay of the conference call will be available for one week beginning one hour after the end of the live conference call.

Webcast: View Source

Availability: Telephonic replay: until Thursday, May 20, 2021; webcast replay: 1 year

The webcast and accompanying PowerPoint presentation will also be archived on the ‘IR Calendar’ page listed under the Investor Relations drop-down menu on the Company’s website.

On May 7, 2021 Sierra Oncology, Inc. (SRRA), a late-stage biopharmaceutical company on a quest to deliver targeted therapies that treat rare forms of cancer, reported its financial and operating results for the first quarter ended March 31, 2021 (Press release, Sierra Oncology, MAY 7, 2021, View Source [SID1234579441]).

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"The first quarter of 2021 has been a hugely productive one for Sierra. We are excited to share that MOMENTUM enrollment has accelerated, and we now anticipate completing enrollment in June 2021. With this updated timing, we expect to report topline results in Q1 2022," said Stephen Dilly, MBBS, PhD, President and Chief Executive Officer of Sierra.

"With enrollment completion just around the corner, we remain highly focused on the ongoing execution of the trial, regulatory filing and commercialization preparation for a potential launch in H1 2023. We are confident positive results of MOMENTUM, combined with the SIMPLIFY data sets, will support our intended regulatory filings and the potential approval of momelotinib for the treatment of myelofibrosis."

Momelotinib is currently under investigation in the pivotal MOMENTUM clinical trial, a global, randomized, double-blind Phase 3 study for symptomatic and anemic myelofibrosis patients. Assuming MOMENTUM data are positive, Sierra plans to file for regulatory approval of momelotinib with the US Food & Drug Administration (FDA) in H2 2022. The FDA has granted Fast Track designation for momelotinib.

As the company approaches pivotal data from its late-stage development of momelotinib, it continues to explore opportunities to expand its pipeline. As a result, Sierra will adjust its development efforts and associated leaders into early- and late-stage clinical development. Effective upon the closure of MOMENTUM screening, which is anticipated to be mid-May, Mark Kowalski, MD, PhD will assume the title of Chief, Research and Early Development, focusing on earlier stage combinations for momelotinib as well as the ongoing evaluation of development opportunities for additional pipeline assets. Barbara Klencke, MD will assume the title of Chief Medical Officer and focus on the late-stage development of momelotinib as well as pre-commercialization medical affairs activities.

First Quarter 2021 Financial Results (all amounts reported in U.S. currency)
Research and development expenses were $14.0 million for the three months ended March 31, 2021 compared with $11.6 million for the three months ended March 31, 2020. The increase was primarily due to costs for momelotinib including a $1.8 million increase in clinical trial and development costs and $0.8 million increase in manufacturing costs. Also attributing to the increase was a $1.7 million increase in personnel-related and allocated overhead costs of which $1.1 million pertained to an increase in non-cash stock-based compensation. These increases were partially offset by a $1.5 million non-cash charge incurred during the three months ended March 31, 2020 to recognize the change in fair value of an obligation to issue securities to Gilead until the issuance of the securities in January 2020, and a $0.4 million decrease in costs for SRA737. Research and development expenses included non-cash stock-based compensation of $1.7 million and $0.5 million for the three months ended March 30, 2021 and 2020, respectively.

General and administrative expenses were $5.9 million for the three months ended March 31, 2021, compared to $4.5 million for the three months ended March 31, 2020. The increase was due to a $1.3 million increase in personnel-related and allocated overhead costs of which $0.9 million pertained to an increase in non-cash stock-based compensation. General and administrative expenses included non-cash stock-based compensation of $1.3 million and $0.4 million for the three months ended March 31, 2021 and 2020, respectively.

Total other income (expense), net was $29,000 of total other expense, net for the three months ended March 31, 2021, compared to $15.7 million of total other expense, net for the three months ended March 31, 2020. The difference was primarily attributable to a non-cash charge of $16.2 million incurred during the three months ended March 31, 2020 related to the change in fair value of warrant liabilities until the reclassification to equity in January 2020.

For the three months ended March 31, 2021, Sierra incurred a Generally Accepted Accounting Principles (GAAP) net loss of $19.9 million compared to a GAAP net loss of $31.9 million for the three months ended March 31, 2020. The GAAP net loss for the three months ended March 31, 2020 includes a non-cash charge of $16.2 million related to the change in fair value of warrant liabilities included in other income (expense), net and a $1.5 million non-cash charge pertaining to the obligation to issue securities to Gilead included in research and development expenses as mentioned above.

Non-GAAP adjusted net loss was $17.0 million for the three months ended March 31, 2021, compared with a non-GAAP adjusted net loss of $13.3 million for the three months ended March 31, 2020. Non-GAAP adjusted net loss for the three months ended March 31, 2021 excludes expense related to stock-based compensation. Non-GAAP adjusted net loss for the three months ended March 31, 2020 excludes expenses related to the change in fair value of warrant liabilities, the change in fair value of the securities issuance obligation, and stock-based compensation. See "Non-GAAP Financial Measures" and "Reconciliation of GAAP to Non-GAAP Financial Measures" below for a reconciliation of this GAAP measure to non-GAAP financial measure.

Cash and cash equivalents totaled $107.7 million as of March 31, 2021, compared to $104.1 million as of December 31, 2020.

As of March 31, 2021, there were 12,349,961 total shares of common stock outstanding and warrants to purchase 11,052,256 shares of common stock, with an exercise price equal to $13.20 per share. There were 4,667,173 shares issuable upon exercise of stock options and an additional warrant to purchase 1,839 shares.

On May 7, 2021 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of small molecule, MasterKey therapies, reported financial results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Black Diamond Therapeutics, MAY 7, 2021, View Source [SID1234579434]).

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"The first quarter of 2021 has been marked by meaningful progress across Black Diamond’s pipeline of MasterKey inhibitor therapies, each of which is designed by leveraging our proprietary MAP platform to address an unmet need for patients with a range of genetically defined cancers," said David M. Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "We look forward to presenting initial clinical data for our lead program, BDTX-189, at the ASCO (Free ASCO Whitepaper) Annual Meeting later this quarter, as well as to continuing to report on progress across the pipeline throughout the year."

Recent Developments

BDTX-189:

Black Diamond continued to enroll and dose patients in the MasterKey-01 study, a Phase 1/2 clinical trial of BDTX-189. More than 50 patients have been dosed with BDTX-189 to date. Eligibility included all solid tumors harboring any of the more than 50 pre-defined genomic alterations in EGFR and human epidermal growth factor receptor 2 (HER2). The Company is on track to complete the dose-escalation portion of the Phase 1 clinical trial in the first half of 2021.
Initial Phase 1 clinical PK, safety, and preliminary efficacy data will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting.
The Company is working toward selection of the recommended Phase 2 dose for BDTX-189 and plans to initiate the safety expansion cohort in the second quarter of 2021. The Phase 2 portion of the MasterKey-01 study is on track to begin in the second half of 2021.
In April 2021, the Company presented pre-clinical data on BDTX-189 at the AACR (Free AACR Whitepaper) Annual Meeting:
Black Diamond employed a novel physiologically based pharmacokinetic (PBPK) modeling strategy, accounting for compound-specific determinants of BDTX-189 metabolism and disposition, to prospectively predict the clinical PK profile and active dose range of BDTX-189.
Preclinical PBPK modeling indicated that BDTX-189 would be readily orally absorbed with a short elimination half-life (approximately two hours) while maintaining suppression of ErbB pathway biomarkers over the dosing interval, consistent with the irreversible mechanism of action and the desired PK/pharmacodynamic (PD) profile.
Active dose levels in humans were projected to be in the 400–800 mg QD range based on the exposure-tumor growth inhibition relationship in multiple mouse patient-derived xenograft (PDX) models harboring ErbB allosteric mutations.
BDTX-1535:

In April 2021, the Company presented pre-clinical data on BDTX-1535 at the AACR (Free AACR Whitepaper) Annual Meeting:
In cell-based assays, BDTX-1535 achieved potent and selective inhibition of all members of the family of oncogenic EGFR variants expressed in GBM.
BDTX-1535 demonstrated a favorable brain-penetrant PK profile in mouse, rat, and dog models.
Tumor growth inhibition in mouse models bearing intracranial GBM6 patient-derived tumors expressing allosteric EGFR mutants was achieved.
BDTX-1535 demonstrated potent and selective inhibition of rare Exon 18 mutations and the C797S mutation, supporting the potential for utility beyond GBM, such as in non-small cell lung cancer (NSCLC).
Black Diamond expects to file an Investigational New Drug (IND) application for BDTX-1535 in the first half of 2022.
Early-Stage Pipeline:

In March 2021, Black Diamond presented pre-clinical data for its B-Raf Proto-Oncogene (BRAF) and fibroblast growth factor receptor (FGFR) programs at European Society for Medical Oncology Targeted Anticancer Therapies Congress:
Black Diamond’s BRAF program candidates have been designed for potency against a spectrum of non-canonical Class II/III (non-V600), as well as to avoid induction of paradoxical activation. Tumor regression in mouse models has been observed.
Black Diamond’s FGFR program candidates are inhibitors with broad coverage of FGFR2 and FGFR3 oncogenes, while sparing inhibition of FGFR1 and retaining activity against gatekeeper mutations. Tumor regression in mouse models has been observed.
The Company anticipates IND filings for both programs in 2022.
Corporate:

In January 2021, Black Diamond appointed oncology clinical development veteran Kapil Dhingra, M.B.B.S., to its Board of Directors.
Financial Highlights

Black Diamond ended the first quarter of 2021 with $290.1 million in cash, cash equivalents, and investments compared to $357.2 million as of March 31, 2020. Net cash used in operations was $24.5 million for the first quarter of 2021 compared to $11.3 million for the first quarter of 2020.
Research and development (R&D) expenses were $22.8 million for the first quarter of 2021 compared to $7.4 million for the first quarter of 2020. The increase in R&D expenses was primarily related to an increase in headcount, and increased spend across preclinical and clinical development.
General and administrative (G&A) expenses were $7.9 million for the first quarter of 2021 compared to $5.5 million for the first quarter of 2020. The increase in G&A expenses was primarily due to an increase in personnel and other corporate-related costs.
Upcoming Events

Initial PK, safety, and preliminary efficacy data from the Phase 1 dose-escalation portion of the MasterKey-01 clinical trial of BDTX-189 in advanced solid tumors will be presented as poster presentations at the ASCO (Free ASCO Whitepaper) Annual Meeting. Presentation details are as follows:
Title: Safety and Preliminary Efficacy from the Phase 1 Portion of MasterKey-01: A First-in-Human Dose-Escalation Study to Determine the Recommended Phase 2 Dose (RP2D), Pharmacokinetics (PK), and Preliminary Antitumor Activity of BDTX-189, an Inhibitor of Allosteric ErbB mutations, in Patients with Advanced Solid Malignancies
Session Type: Poster Session
Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Date and Time: Friday, June 4, 9:00 AM ET
Abstract ID: 3086
Title: Clinical pharmacokinetics of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients with advanced solid malignancies in MasterKey-01 study
Session Type: Poster Session
Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Date and Time: Friday, June 4, 9:00 AM ET
Abstract ID: 3097
About BDTX-189

BDTX-189 is an orally available, irreversible, and ATP competitive small molecule inhibitor that is designed to block the function of a family of oncogenic epidermal growth factor receptor (EGFR) and ErbB-2 (epidermal growth factor receptor 2 [HER2]) proteins across a range of tumor types. BDTX-189 is designed as a MasterKey inhibitor targeting a family of previously undrugged and functionally similar oncogenic mutations in a tumor-agnostic manner. These mutations include extracellular domain allosteric mutations of HER2, as well as EGFR and HER2 kinase domain Exon 20 insertions, and additional activating oncogenic drivers of ErbB. The ErbB receptors are a group of receptor tyrosine kinases involved in key cellular functions, including cell growth and survival. BDTX-189 is also designed to spare normal, or wild-type, EGFR, which we believe has the potential to improve upon the toxicity profiles of current ErbB kinase inhibitors. Currently, there are no medicines approved by the U.S. Food and Drug Administration (FDA) to target all of these oncogenic mutations with a single therapy.

BDTX-189 is currently being evaluated in a Phase 1/2 clinical trial (MasterKey-01) in adult patients with advanced solid tumors expressing a range of alterations of ErbB receptors, including oncogenic MasterKey mutations, HER2-WT amplification, HER3 mutation, EGFR exon 19 deletion, and L858R mutation who have no standard therapy available or for whom standard therapy is considered unsuitable or intolerable. In July 2020, the FDA granted Fast Track designation to BDTX-189 for the treatment of adult patients with solid tumors harboring an allosteric HER2 mutation or an EGFR or HER2 Exon 20 insertion mutation who have progressed following prior treatment and who have no satisfactory treatment options.