On March 15, 2022 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported financial results for the quarter and full-year ended December 31, 2021, and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, MAR 15, 2022, View Source [SID1234610130]).

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"2021 was a pivotal year for Syros, marked by the initiations of three clinical trials and one expansion cohort across our targeted hematology and CDK inhibitor portfolios, promising data from our SY-5609 program, as well as the appointments of two key leadership team members," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "We believe we are well-positioned to build on this momentum in 2022. We expect three data readouts this year, including pharmacokinetic and safety data from our dose confirmation trial of SY-2101 in APL as well as clinical activity data from the safety lead-in portions of the SELECT-AML-1 Phase 2 trial and the expansion cohort of SY-5609 in pancreatic cancer. These results have the potential to deliver important insights into each of our investigational medicines as we continue to advance towards becoming a fully integrated biopharmaceutical company with the aim to make a profound difference for patients."

UPCOMING MILESTONES

Targeted Hematology

Tamibarotene: Oral RARα agonist

Report clinical activity data from safety lead-in portion of ongoing SELECT-AML-1 Phase 2 trial in newly diagnosed unfit RARA-positive patients with acute myeloid leukemia (AML) in the second half of 2022.
Report data from ongoing SELECT-MDS-1 Phase 3 trial in newly diagnosed RARA-positive patients with higher-risk myelodysplastic syndrome (HR-MDS) in the fourth quarter of 2023 or first quarter of 2024, with a potential new drug application (NDA) filing expected in 2024.
SY-2101: Oral arsenic trioxide (ATO)

Report pharmacokinetic (PK) and safety data from ongoing dose confirmation trial in newly diagnosed acute promyelocytic leukemia (APL) patients in mid-2022.
Initiate Phase 3 trial in first quarter of 2023 with data expected in 2025.
CDK Inhibition

SY-5609: Oral Selective CDK7 Inhibitor

Report clinical activity data from safety lead-in portion of ongoing expansion cohort evaluating SY-5609 in combination with chemotherapy in relapsed/refractory metastatic pancreatic cancer patients in the second half of 2022.
Roche plans for the arm of its ongoing Phase 1/1b INTRINSIC trial investigating SY-5609 in combination with atezolizumab in BRAF-mutant colorectal cancer (CRC) to be open for enrollment in the first half of this year. Under the terms of our agreement with Roche, Roche is the sponsor of the trial and Syros is supplying SY-5609.
Initiate Phase 1 trial evaluating SY-5609 in relapsed/refractory hematologic malignancies in the second half of 2022, with initial data expected mid-2023.
Gene Control Discovery Engine

Plan to present new preclinical data on the CDK12 inhibitor program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, taking place from April 8-13.
Nominate next development candidate, a CDK12 inhibitor, in the second half of 2022.
RECENT PIPELINE HIGHLIGHTS

In February, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to tamibarotene for the treatment of HR-MDS. The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 200,000 people in the United States. Orphan drug designation may provide certain benefits, including a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.
CORPORATE

In March, Syros entered into a Master Collaboration Agreement with QIAGEN to develop and commercialize an assay as a companion diagnostic for Syros’ proprietary RARA biomarker for use with tamibarotene in newly diagnosed HR-MDS patients. QIAGEN will also be responsible for obtaining and maintaining regulatory approvals for the commercial diagnostic test.
FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS

Revenues were $7.8 million for the fourth quarter of 2021, consisting of $6.5 million in revenue recognized under Syros’ collaboration with Global Blood Therapeutics, Inc. (GBT) and $1.3 million recognized under its collaboration with Incyte Corporation (Incyte). Revenues were $23.5 million for the year ended December 31, 2021, consisting of $19.4 million and $4.1 million from Syros’ collaborations with GBT and Incyte, respectively. Syros recognized $5.7 million in revenue in the fourth quarter of 2020, consisting of $3.6 million in revenue recognized under its collaboration with GBT and $2.1 million recognized under its collaboration with Incyte, and $15.1 million for the year ended December 31, 2020, consisting of $11.7 million and $3.4 million from its collaborations with GBT and Incyte, respectively.
Research and development expenses were $26.8 million for the fourth quarter of 2021 and $99.9 million for the year ended December 31, 2021, as compared to $29.0 million for the fourth quarter of 2020 and $76.1 million for the year ended December 31, 2020. The decrease for the fourth quarter of 2021 compared to the same period in 2020 was primarily due to the purchase of SY-2101 in the fourth quarter of 2020. The increase for the year ended December 31, 2021 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 $6.4 million for the fourth quarter of 2021 and $23.0 million for the year ended December 31, 2021, as compared to $5.9 million for the fourth quarter of 2020 and $21.3 million for the year ended December 31, 2020.
For the fourth quarter of 2021, Syros reported a net loss of $23.8 million, or $0.38 per share, compared to a net loss of $30.1 million, or $0.62 per share, for the same period in 2020. For the full year ended December 31, 2021, Syros reported a net loss of $86.6 million, or $1.38 per share, compared to a net loss of $84.0 million, or $1.82 per share, for the same period in 2020.
Cash and Financial Guidance

Cash, cash equivalents and marketable securities as of December 31, 2021 were $143.4 million, as compared with $174.0 million on December 31, 2020. This change reflects cash used to fund Syros’ operations during the full year ended December 31, 2021, partially offset by gross proceeds of $75.6 million that Syros received from its January 2021 public offering.

Based on its current plans, Syros believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its planned operating expenses and capital expenditure requirements into the first quarter of 2023.

Conference Call and Webcast

Syros will host a conference call today at 8:30 a.m. ET to discuss these fourth quarter and full year 2021 financial results and provide a corporate update.

To access the live conference call, please dial (866) 595-4538 (domestic) or (636) 812-6496 (international) and refer to conference ID 9682507. 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 March 15, 2022 Epizyme (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering transformative therapies for cancer patients against novel epigenetic targets, reported a clinical update as well as the appointment of Jerald Korn as Chief Operating Officer, reporting to President and Chief Executive Officer, Grant Bogle (Press release, Epizyme, MAR 15, 2022, View Source [SID1234610129]).

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"We are excited to welcome Jerald to Epizyme at a pivotal time for the organization," said Mr. Bogle. "Jerald’s breadth of experience leading a wide range of functions and working in biotech companies at our stage of development will be a welcomed addition to our senior executive team as we look to drive growth for TAZVERIK (tazemetostat) as a monotherapy, as well as advance the tazemetostat clinical development program across both hematologic and solid tumor malignancies."

"I am thrilled to be joining Epizyme at such an important time for the company," said Mr. Korn. "I have a passion for working in the oncology space and am excited by the opportunity to help execute on the continued launch of TAZVERIK and to fulfill Epizyme’s vision of developing transformative epigenetic medicines. I look forward to working alongside this incredible team as we focus on the strategic priorities where we believe we can make a meaningful impact for people living with cancer."

With more than 15 years in the biotech industry, Mr. Korn most recently served as the Chief Operating Officer and General Counsel at Kaleido Biosciences, where he oversaw legal, human resources, program management, quality, regulatory and other operations, as well as supporting the company with corporate strategy, including two financings, a pipeline prioritization and transition to a new laboratory and manufacturing facility. Prior to Kaleido, Mr. Korn held several leadership positions at TESARO, as well as senior positions at Cubist Pharmaceuticals, Millennium Pharmaceuticals (part of Takeda) and AMAG Pharmaceuticals. Mr. Korn began his career as an associate at the law firm Ropes & Gray and holds a bachelor’s degree with honors in economics from Harvard University and a J.D. with honors from Boston University School of Law.

SYMPHONY-1 Clinical Update

Epizyme also reported today that the first patient has been dosed in the Phase 3 portion of the SYMPHONY-1 (EZH-302) study, a confirmatory study assessing tazemetostat in combination with rituximab + lenalidomide (R2) compared with R2 plus placebo in patients with relapsed or refractory follicular lymphoma (R/R FL) previously treated with at least one systemic therapy, including those who are rituximab-refractory and/or have experienced progression of disease within two years.

"Dosing the first patient in the Phase 3 portion of the SYMPHONY-1 study is an important milestone for Epizyme and our clinical development of tazemetostat in R/R FL," said Dr. Shefali Agarwal, Executive Vice President and Chief Medical and Development Officer at Epizyme. "As we enroll patients in the Phase 3 randomized portion of the study, we plan to continue to report longer term follow-up data from the Phase 1b safety run-in portion of the study as well as data from other combination studies of tazemetostat in both hematological and solid tumor malignancies that we are conducting."

Epizyme previously announced the completion of the 30-day waiting period for its protocol amendment submitted to the U.S. Food and Drug Administration in December 2021 with 800 mg twice-daily as the recommended Phase 3 dose. The Company is now engaged in global start-up activities, including sites in greater China with its collaboration partner HUTCHMED. The latest results of the Phase 1b safety run-in portion of the study were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021 and can be accessed here.

About TAZVERIK (tazemetostat)

TAZVERIK is a methyltransferase inhibitor indicated for the treatment of:

Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications is contingent upon verification and description of clinical benefit in confirmatory studies.

The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

On March 15, 2022 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported it will host a virtual Investor Day on Tuesday, March 22, 2022, from 11:00 a.m. to 12:30 p.m. Eastern Time (Press release, Aura Biosciences, MAR 15, 2022, View Source [SID1234610128]). Aura Bioscience’s executive management team will be joined by two distinguished ocular oncology thought leaders:

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Carol Shields, MD, Chief of the Ocular Oncology Service at Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University (Philadelphia, PA)
Hans Grossniklaus, MD, MBA, Senior Professor of Ophthalmology and Founding Director of the Ocular Oncology and Pathology Service at Emory University (Atlanta, GA)
The program will include an overview of choroidal melanoma (CM), AU-011’s novel mechanism of action, and a summary of the clinical data on AU-011 in CM to date, followed by a moderated Q&A with Drs. Shields and Grossniklaus. The Company plans to select the route of administration and treatment regimen for AU-011 in CM and initiate the pivotal program in the second half of 2022.

To access the virtual event, please dial (877) 958-0846 (U.S. and Canada) or (778) 360-2654 (international) at least 10 minutes prior to the start time and refer to conference ID 7158466. A live video webcast will be available in the Investor section of the Company’s website at View Source A webcast replay will also be available on the corporate website at the conclusion of the call.

On March 15, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, reported financial results for the year and quarter ended December 31, 2021 (Press release, Gamida Cell, MAR 15, 2022, View Source [SID1234610127]). Net loss for 2021 was $89.8 million, compared to a net loss of $61.6 million in 2020. As of December 31, 2021, Gamida Cell had total cash and cash equivalents of $95.9 million.

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During the past quarter and into 2022, Gamida Cell:

Continued to advance omidubicel, a potentially life-saving cell therapy treatment for patients with blood cancers in need of stem cell transplant. In the first quarter of 2022, Gamida Cell initiated a rolling Biologics License Application (BLA) submission for omidubicel following the receipt of positive Type B meeting correspondence from the U.S. Food and Drug Administration (FDA).
Progressed activities to address the FDA’s clinical hold on the Investigational New Drug (IND) application for GDA-201, which was imposed based on FDA questions about donor eligibility procedures and assay qualification prior to the initiation of the study in patients with follicular and diffuse large B-cell lymphomas.
Advanced the company’s NAM-enabled natural killer (NK) cell pipeline, including targets GDA-301, GDA-501 and GDA-601, which focus on solid-tumor and hematological cancers. These targets utilize CAR, membrane bound- and CRISPR-mediated technologies to increase targeting, potency and persistence against hematologic malignancies and solid tumors.
"Throughout 2021, Gamida Cell made meaningful progress advancing our broad immunotherapy pipeline of potentially curative cell therapies for patients with solid tumor and blood cancers and other serious blood diseases, resulting in the recent initiation of our rolling BLA submission for omidubicel, which we expect to complete in the second quarter of this year. Additionally, we are continuing to work diligently to respond to the FDA regarding our IND for GDA-201, and expect to initiate our Phase 1/2 study in patients with follicular and diffuse large B-cell lymphomas once the clinical hold has been removed," said Julian Adams, Ph.D., chief executive officer of Gamida Cell. "Looking ahead in 2022, we are continuing to progress our genetically modified NK cell immunotherapy programs leveraging CAR- and CRISPR-mediated technologies focused on addressing unmet needs for patients with hematologic malignancies and solid tumors and we will select a product candidate for IND-enabling studies by the end of the year."

Fourth Quarter and Recent Developments

Omidubicel: Advanced Cell Therapy

BLA submission: Following the receipt of positive Type B meeting correspondence from the FDA confirming that analytical comparability has been established between Gamida Cell’s wholly-owned commercial manufacturing facility and the product that was manufactured for the Phase 3 study, Gamida Cell initiated a rolling BLA submission for omidubicel in the first quarter of 2022. As part of the rolling BLA, Gamida Cell submitted the nonclinical and clinical modules of the omidubicel BLA and is on-track to complete submission of all remaining modules of the BLA by the first half of 2022. In parallel with the BLA submission, the company is assessing alternatives for the commercialization of omidubicel, including potential U.S. or global partnerships.
New data presented at ASH (Free ASH Whitepaper): At the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2021, Gamida Cell presented clinical updates and a health economic analysis on hospital resource utilization.
Data collected from a subset of patients in the omidubicel Phase 3 trial showed that, in addition to more rapid short-term hematopoietic recovery, omidubicel-treated patients had more rapid recovery of a wide variety of immune cells including CD4+ T cells, B cells, monocytes, NK cells, and dendritic cells than the control arm. The robust recovery of a broad range of the immune system correlated with and supported clinical data showing fewer severe bacterial, fungal, and viral infections in patients treated with omidubicel.
Resource utilization data during the first 100 days after transplant showed that omidubicel-treated patients had significantly shorter durations of hospitalization, intensive care unit time, consultant visits, procedures, and transfusions than the control arm. These data provide further evidence of the clinical benefit associated with the more rapid hematopoietic recovery in patients treated with omidubicel and the corresponding reduction in healthcare resource utilization.
An analysis of outcomes of patients with hematologic malignancies treated with omidubicel over a 10-year period showed long-term sustained bone marrow function and immune recovery, with a 10-year overall survival of 48%. These data provide further support for the long-term clinical benefit of omidubicel with long-lasting hematopoietic recovery.
GDA-201: NAM-Enabled NK Cell Therapy

IND for Phase 1/2 Study: Gamida Cell is working diligently to address the clinical hold on the IND for a Phase 1/2 study of GDA-201. Gamida Cell expects to initiate a company-sponsored Phase 1/2 clinical study in patients with follicular and diffuse large B-cell lymphomas in 2022.
New data presented at ASH (Free ASH Whitepaper): Gamida Cell presented 2-year survival and correlation data with cytokine IL7 at the ASH (Free ASH Whitepaper) Annual Meeting and Exposition in December 2021. This analysis provided longer follow-up in the investigator-led study of GDA-201 in patients with non-Hodgkin lymphoma and demonstrated an overall survival rate of 78% at two years with a median duration of response of 16 months.
NAM-Enabled NK Cell Pipeline Expansion

Advanced NAM-enabled genetically modified NK pipeline: Gamida Cell continues to progress its NAM-enabled genetically modified NK pipeline, which utilizes CAR, membrane bound- and CRISPR-mediated technologies to increase targeting, potency and persistence against hematologic malignancies and solid tumors. The company plans to execute preclinical proof of concept studies for these genetically modified NK therapeutic targets and to select a product candidate for IND enabling studies by the end of 2022. These therapeutic targets include:
GDA-301: Knockout of CISH (cytokine inducible SH2 containing protein) in NK cells using CRISPR/Cas9 in combination with a membrane-bound IL-15/IL-15Ra;
GDA-501: anti HER2 CAR-engineered NK cells to target solid tumors expressing HER2, based on a single-chain variable fragment of the widely used humanized monoclonal antibody trastuzumab; and
GDA-601: CRISPR Knockout of CD38 on NK cells combined with anti CD38 CAR. CD38 is an established immunotherapeutic target in multiple myeloma, but its expression on NK cells and its further induction during ex vivo NK cell expansion represents a barrier to the development of an anti CD38 CAR-NK cell therapy. Gamida Cell is advancing this program with a collaboration with the Dana-Farber Cancer Institute to study the in vitro cytotoxicity of GDA-601 in fresh samples from multiple myeloma patients.
GDA-401: A development candidate with the target still undisclosed.
Full Year 2021 Financial Results

Research and development expenses were $50.2 million in 2021, compared to $38.9 million in 2020. The increase was primarily due to a $5.4 million increase in omidubicel commercial manufacturing readiness activities and advancing the NK programs, as well as an increase of $5.9 million in broadening the company scientific capabilities and talent.
Commercial expenses in 2021 were $20.0 million, compared to $8.9 million in 2020. The increase was attributable mainly to a $6.5 million increase in commercial readiness expenses and a $4.6 million increase in headcount within the commercial organization. Going forward, the company anticipates reducing its near-term commercial readiness expenses, as it is assessing alternatives for the commercialization of omidubicel, including potential U.S. or global partnerships.
General and administrative expenses were $17.0 million in 2021, compared to $13.2 million in 2020. The increase was mainly due to a $2.6 million increase in professional services expenses and a $1.2 million increase in headcount and related expenses.
Finance expenses, net, were $2.6 million for 2021, compared to $0.6 million for 2020. The increase was primarily due to a $4.4 million interest expenses from convertible notes, offset by a $2.1 million capitalization and other non-cash expenses, and a $0.3 million increase in interest income from cash management.
Net loss for 2021 was $89.8 million, compared to a net loss of $61.6 million in 2020.
2022 Financial Guidance

Gamida Cell expects cash used for ongoing operating activities in 2022 to range from $60 million to $70 million.

Gamida Cell expects that its current cash and cash equivalents will support the company’s ongoing operating activities into mid 2023. This cash runaway guidance is based on the company’s current operational plans and excludes any additional funding and any business development activities that may be undertaken.

Expected Milestones in 2022

Omidubicel

Completion of full BLA submission to the FDA in the first half of 2022
GDA-201

Initiation of a company-sponsored Phase 1/2 clinical study in follicular and diffuse large B-cell lymphomas
NK cell pipeline expansion

Establish preclinical proof of concept studies of the NAM-enabled, genetically modified NK therapeutic targets
Select pipeline candidate for IND-enabling studies
Conference Call Information

Gamida Cell will host a conference call today, March 15, 2022, at 8:00 a.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 1696742. A recording of the webcast will be available approximately two hours after the event, for approximately 30 days.

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the U.S. FDA and has also received Orphan Drug Designation in the U.S. and EU. Gamida Cell has completed an international, multi-center, randomized Phase 3 study (NCT0273029) evaluating the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing allogeneic bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant. That study achieved its primary endpoint, demonstrating a highly statistically significant reduction in time to neutrophil engraftment, a key milestone in a patient’s recovery from a stem cell transplant. The Phase 3 study also achieved its secondary endpoints of reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. Gamida Cell initiated a rolling BLA submission for omidubicel in the first quarter of 2022 with full BLA submission on track for first half of 2022. For more information about omidubicel, please visit View Source

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About GDA-201

Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical trial results. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, GDA-201 improves antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. Gamida Cell expects to initiate a company-sponsored Phase 1/2 clinical study of GDA-201 in patients with follicular and diffuse large B-cell lymphomas in 2022. For more information about GDA-201, please visit View Source

GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

On March 15, 2022 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company leveraging the power of the mitochondria and the peptides encoded in its genome to develop potential breakthrough therapeutics targeting chronic and age-related diseases, reported that the company will release its 2021 fourth quarter and full year financial results after the market closes on Tuesday, March 29, 2022 (Press release, CohBar, MAR 15, 2022, View Source [SID1234610126]). Management will host a conference call and webcast at 5:00 p.m. ET (2:00 p.m. PT) on the same day to provide an update on the company’s business.

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Details for the Conference Call:

Webcast
– A simultaneous webcast of the call will be accessible via the Investors section of the CohBar website at www.cohbar.com.
For individuals participating in the Investor Call or webcast, please call or login to the conference audio approximately 10 minutes prior to its start.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on March 29, 2022, through 11:59 p.m. Eastern Time on April 19, 2022. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 13726040. The audio recording will also be available at www.cohbar.com during the same period.