On March 29, 2022 Lyell Immunopharma, Inc., (Nasdaq: LYEL), a T-cell reprogramming company dedicated to the mastery of T cells to cure patients with solid tumors, reported fourth quarter and full year 2021 financial results and provided business highlights (Press release, Lyell Immunopharma, MAR 29, 2022, View Source [SID1234611113]).

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"With the recent FDA clearance of two INDs that incorporate our novel genetic and epigenetic reprogramming technologies, we are now a clinical stage-company advancing a pipeline of novel cell therapies for patients with solid tumors," said Liz Homans, CEO of Lyell Immunopharma. "During the past year, we’ve further strengthened our team with key executive and Board appointments and have grown the organization to focus on executing as a fully integrated clinical stage company. The coming year will be an exciting one for us as we initiate multiple clinical trials across our product pipeline. We are eager to clinically assess the impact of our innovative technologies designed to enable reprogrammed T cells to outlast and eradicate solid tumors in patients."

"We are embarking on what I believe to be among the most informative clinical trials in the field of oncology this year, as they will specifically evaluate the questions of exhaustion and durable stemness as key barriers to successful cell therapies for solid tumor cancers," stated Rick Klausner, MD, Chair of Lyell’s Board of Directors.

Full Year 2021, Recent Highlights, and Upcoming Milestones

LYL797, a chimeric antigen receptor (CAR) T-cell therapy targeting ROR1+ solid tumors that incorporates Gen-R and Epi-R reprogramming technologies

Announced FDA clearance of the IND for LYL797, a CAR T-cell therapy for patients with solid tumors expressing receptor tyrosine kinase-like orphan receptor 1 (ROR1).
The two Lyell technologies incorporated are designed to address major barriers to successful Adoptive Cell Therapy (ACT): Gen-R, a genetic reprogramming technology that endows T cells with the ability to resist exhaustion, and Epi-R, an epigenetic reprogramming technology that creates populations of T cells with the properties of durable stemness. T cells with properties of durable stemness are able to proliferate, persist and self-renew, as well as generate differentiated effector cell progenies to provide durable anti-tumor functionality.
Initiated screening for the Phase 1 open label dose escalation and expansion trial with relapsed/refractory triple-negative breast cancer or non-small cell lung cancer who have failed at least two lines of therapy, initial data expected in 2023.
LYL132, a TCR therapy targeting NY-ESO-1 solid tumors that incorporates Epi-R, being developed in collaboration with GSK for solid tumors

Announced FDA clearance of the IND for LYL132, a T-cell receptor (TCR) therapy for patients with solid tumors expressing New York esophageal squamous cell carcinoma 1 (NY-ESO-1).
LYL132 incorporates Epi-R and is under investigation as a potential next-generation enhancement to letetresgene autoleucel (lete-cel), a GSK TCR therapy targeting NY-ESO-1 currently in pivotal clinical development.
LYL845, a TIL therapy designed to target multiple solid tumor indications that incorporates Epi-R

On track to submit an IND in the second half of 2022 for LYL845, a tumor infiltrating lymphocyte (TIL) therapy.
Initially targeting melanoma, with plans to expand into other solid tumor indications, potentially including non‑small cell lung cancer (NSCLC), colon, head and neck, cervical, breast and pancreatic.
LYL331, a TCR therapy targeting NY-ESO-1 solid tumors that incorporates Gen-R, being developed in collaboration with GSK for solid tumors

GSK has communicated to Lyell that due to updated manufacturing timing, the IND for LYL331 is likely to be submitted in late 2022 / early 2023.
LYL331 is a TCR therapy for patients with solid tumors expressing NY-ESO-1.
LYL331 incorporates Gen-R and, along with LYL132, is under investigation as a potential next-generation enhancement to lete-cel.
Corporate and Operational

Lyell had the following corporate and operational highlights during 2021:

Announced cGMP qualification of LyFE, Lyell’s manufacturing facility designed to produce cell products at scale for upcoming clinical trials across its CAR, TIL and TCR products.
Completed an initial public offering with net proceeds of $391.8 million from the sale of 25 million shares of common stock.
Expanded executive management team with appointments of scientific and business leaders: Gary Lee, PhD appointed as Chief Scientific Officer and Charlie Newton appointed as Chief Financial Officer.
Expanded Board of Directors with appointments of industry and medical leaders: Otis Brawley, M.D., Elizabeth Nabel, M.D. and Lynn Seely, M.D.
Fourth Quarter and Full 2021 Financial Results

GAAP and Non-GAAP Operating Results

Lyell reported a net loss of $83.7 million and $250.2 million for the fourth quarter and year ended December 31, 2021, respectively, compared to $38.9 million and $204.5 million for the same periods in 2020. Non-GAAP net loss, which excludes non-cash stock-based compensation, non-cash expenses related to the change in the estimated fair value of success payment liabilities and non-cash impairment adjustment of other investments, was $41.7 million and $147.9 million for the fourth quarter and year ended December 31, 2021, respectively, compared to $24.3 million and $165.9 million for the same periods in 2020.
Research and development (R&D) expenses were $19.3 million and $138.7 million for the fourth quarter and year ended December 31, 2021, respectively, compared to $35.1 million and $182.2 million for the same periods in 2020. The quarterly decrease in R&D expense on a GAAP basis was primarily due to a decrease in success payment expense, which offset an increase in personnel and infrastructure costs to support the expansion of our R&D and manufacturing capabilities. The annual decrease in R&D expense on a GAAP basis was primarily due to a decrease in collaboration and business development activity. Non-GAAP R&D expenses, which exclude non-cash stock-based compensation and non-cash expenses related to the change in the estimated fair value of success payment liabilities, for the fourth quarter and year ended December 31, 2021 were $32.2 million and $119.7 million, respectively, compared to $27.6 million and $161.9 million for the same periods in 2020.
General and administrative (G&A) expenses were $31.9 million and $89.1 million for the fourth quarter and year ended December 31, 2021, respectively, compared to $14.9 million and $46.9 million for the same periods in 2020. The increase in G&A expense on a GAAP basis was primarily due to an increase in personnel-related expenses, including stock-based compensation expense. Non-GAAP G&A expenses, which exclude non-cash stock-based compensation, for the fourth quarter and year ended December 31, 2021 were $13.4 million and $42.2 million, respectively, compared to $7.8 million and $28.6 million for the same periods in 2020.
Total other (loss) income, net was $(36.2) million and $(35.4) million for the fourth quarter and year ended December 31, 2021, respectively, compared to $0.7 million and $7.5 million for the same periods in 2020. The decrease in total other (loss) income, net was due primarily to the full impairment of our investment in PACT Pharma, Inc. Series C-1 convertible preferred stock valued at $36.4 million for the year ended December 31, 2021.
A discussion of these non-GAAP financial measures, including reconciliations of the most comparable GAAP measures to non-GAAP financial measures, is presented below under "Non-GAAP Financial Measures."

Cash, cash equivalents and marketable securities

Cash, cash equivalents and marketable securities as of December 31, 2021 were $898.3 million, compared to $692.6 million as of December 31, 2020, an increase of $205.7 million that supports the advancing of our multi-modality cell therapy pipeline. Lyell successfully completed its initial public offering in June 2021 with net proceeds of $391.8 million. Based on the current operating plan, Lyell believes that its cash, cash equivalents and marketable securities balances will be sufficient to meet working capital and capital expenditure needs into 2025.

On March 29, 2022 Sumitomo Dainippon Pharma Oncology, Inc., a clinical-stage pharmaceutical company focused on research and development for novel cancer therapeutics, reported that the first patient has been dosed in the Phase 1/2 study of DSP-5336, an inhibitor of menin binding to mixed-lineage leukemia (MLL) protein, in patients with relapsed or refractory acute myeloid leukemia (AML) or acute lymphocytic leukemia (ALL) (Press release, Sumitomo Dainippon Pharma, MAR 29, 2022, View Source [SID1234611150]).

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"Patients with refractory or relapsed AML or ALL have an unfavorable prognosis and respond poorly to available treatments.1 Dosing the first patient in our Phase 1/2 study is an important milestone as we evaluate DSP-5336 and its safety and potential benefits for this patient population," said Patricia S. Andrews, Chief Executive Officer, Global Head of Oncology, Sumitomo Dainippon Pharma Oncology, Inc (SDP Oncology). "It is our hope that the data generated by this study furthers our goal of advancing meaningful treatments for patients with blood cancer."

The Phase 1/2 open-label study consists of two parts, dose escalation and dose expansion. The primary objectives of the Phase 1 dose escalation portion of the study are to assess the safety and tolerability of DSP-5336 in relapsed or refractory AML or ALL and to determine the recommended Phase 2 dose (RP2D). Secondary objectives include assessment of preliminary clinical activity of DSP-5336 in adult patients with relapsed or refractory AML or ALL.

Following the completion of the Phase 1 dose escalation portion of the study, the study will move into the Phase 2 dose expansion. The primary objective of the Phase 2 dose expansion portion of the study is to further evaluate the safety and clinical activity of DSP-5336 in adult patients with relapsed or refractory AML who have MLL rearrangement or nucleophosmin 1 (NPM1) mutation.

Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT04988555).

About DSP-5336

DSP-5336 is a small molecule inhibitor against the binding of menin and mixed-lineage leukemia (MLL) protein. Menin is a scaffold nuclear protein that plays various key roles in biological pathways, including cell growth regulation, cell cycle control, genomic stability, bone development, and hematopoiesis.2, 3 Binding of menin to MLL fusion and wildtype proteins leads to the upregulation of HOXA family and MEIS1 genes that function to stall myeloid cellular differentiation and induce leukemogenic transformation.2,4,5 Preclinical evidence shows that the disruption of fusion and wild-type menin-MLL interactions inhibits leukemic cell proliferation and restores terminal differentiation of MLL-rearranged and nucleophosmin 1 (NPM1)–mutated leukemic cells.1,6 (NCT04988555).

On March 29, 2022 Vyant Bio, Inc. ("Vyant Bio", "Company") (Nasdaq: VYNT), an innovative biotechnology company reinventing drug discovery for complex neurodevelopmental and neurodegenerative disorders and OrganoTherapeutics, a developer of proprietary patient-specific organoids that recapitulate Parkinson’s Disease (PD) pathology, reported they have entered into a collaboration agreement to work toward accelerating the discovery of drugs for the treatment of Parkinson’s Disease (Press release, Vyant Bio, MAR 29, 2022, View Source [SID1234611213]).

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The collaboration brings together the respective teams’ expertise in drug discovery using human-derived cells, high-throughput biology and chemistry, and machine learning-based therapeutic design to identify potential PD drugs. Together, they will focus on the identification of drug candidates that rescue the PD phenotype through the development of disease-linked, clinically- translatable assays and biomarkers through multiple molecular, biochemical, and cellular methods. This approach will integrate and leverage OrganoTherapeutic’s complex, patient-derived, 3D-organoid disease models derived from induced pluripotent stem cells (iPSCs), and Vyant Bio’s iPSC expertise and its AnalytiXTM machine learning technology.

OrganoTherapeutics has developed Parkinson’s Disease-specific midbrain organoids from multiple PD patients, providing the ability to more fully understand drug response based on genetic differences. Robert Fremeau, PhD, Vyant Bio’s Chief Scientific Officer, states "This collaboration with OrganoTherapeutics is another example of Vyant Bio’s commitment to accelerate the discovery and development of transformative therapies for patients living with severe CNS diseases. We are pleased to announce this collaboration with OrganoTherapeutics as they bring deep knowledge and innovative approaches to Parkinson’s Disease-based drug discovery. Together, we will expand our human-first platform in neurodevelopmental disorders such as Rett Syndrome and CDKL5 deficiency disorder into Parkinson’s Disease and ultimately other neurodegenerative disorders."

Jens Schwamborn, PhD, OrganoTherapeutics Co-Founder and CEO, confirms the anticipated benefits of the collaboration, "The specific genetic and environmental causes in most Parkinson’s patients are unknown. By focusing initially on disease-linked genetic mutations, we plan to identify common causes and potential therapeutic approaches that can be expanded into the much larger patient population. We look forward to integrating our approaches with Vyant Bio."

"We know that therapies for diseases that affect the CNS are difficult to discover: it requires meaningful innovation and exceptional scientific expertise to tackle," said Jay Roberts, CEO of Vyant Bio. "This collaboration is another in a series of strategic moves to focus our efforts while accelerating our position in drug discovery through the use of technologies that allow insight into human biology early in the discovery of CNS drugs."

On March 29, 2022 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing IgM antibodies, reported its financial results for the fourth quarter and full year ended December 31, 2021 and provided an update on recent developments (Press release, IGM Biosciences, MAR 29, 2022, View Source [SID1234611089]).

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"IGM continues to make progress in creating a new class of antibody medicines, which strengthens our commitment to use our expertise to develop and improve upon the inherent qualities of IgM antibodies," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "Notably, our exclusive collaboration agreement with Sanofi, announced today, will accelerate the development of our IgM antibody platform across multiple areas of high unmet need beyond our current pipeline efforts. This partnership is a significant step towards exploring and validating our platform in multiple therapeutic areas, and we look forward to working with Sanofi’s impressive team. Simultaneously, our pipeline continues to progress with considerable speed. Namely, the initiation of two Phase 2 studies for our T cell bispecific antibody IGM-2323 and the continued progress in our DR5 agonist IGM-8444 Phase 1 combination treatment regimens. We look forward to sharing information on these efforts later this year."

Global R&D Collaboration with Sanofi

An exclusive worldwide collaboration agreement with Sanofi for multiple oncology, autoimmune and inflammation targets was announced.
IGM and Sanofi will leverage IGM’s proprietary IgM antibody technology platform to discover IgM antibody agonists against three oncology targets and three autoimmune/inflammation targets.
IGM will receive a $150 million upfront payment and potentially over $6 billion in aggregate development, regulatory and commercial milestones. A 50:50 profit share in certain major market countries and tiered royalties in the rest of world is planned for oncology targets, and IGM will receive tiered royalties for autoimmune/inflammation targets. Sanofi has also expressed an interest in purchasing up to $100 million of IGM non-voting common stock in a public financing.
Closing of the collaboration is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S., and other customary closing conditions.
Pipeline Updates

IGM-2323 (CD20 x CD3)

Phase 2 studies initiated. IGM announced the initiation of two Phase 2 studies to assess the safety and efficacy of two doses of IGM-2323, 100 mg and 300 mg, in patients with diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (FL). If supportive, the data from this Phase 2 multicenter, open-label study could potentially be used as the basis for accelerated review and approval of IGM-2323.
Presented Phase 1 clinical results: In December 2021, IGM presented clinical results from its Phase 1 trial evaluating IGM-2323 at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. The data was featured in an oral presentation titled "A Phase 1 Dose Escalation Study of IGM-2323, a Novel Anti-CD20 x Anti-CD3 IgM T Cell Engager (TCE) in Patients with Advanced B-Cell Malignancies".
IGM-8444 (DR5)

Clinical development of IGM-8444 advances. IGM continues to advance the clinical development of IGM-8444, the Company’s IgM DR5 agonist, in an open-label, multicenter, Phase I study of IGM-8444 as a single agent and in combination in subjects with relapsed and/or refractory solid and hematologic cancers. IGM expects to report initial monotherapy and combination data in solid tumors from the dose escalation portion of this Phase 1 trial in 2022.
Third FOLFIRI dose cohort successfully completed. IGM announced that it has cleared the third of four planned FOLFIRI combination dose escalation cohorts (3.0 mg/kg Q2W) with no dose limiting toxicities (DLTs) and no clinically significant liver toxicity observed to date. IGM is currently enrolling patients in the final planned FOLFIRI combination dose escalation cohort (10.0 mg/kg Q2W).
First birinapant dose cohort successfully completed. IGM also announced that it has cleared the first of four planned birinapant combination dose escalation cohorts with no DLTs and no clinically significant liver toxicity observed to date. IGM is currently enrolling patients in the second planned birinapant combination dose escalation cohort.
IGM-7354 (IL-15 x PD-L1)

IND filing expected in 2022. IGM expects to file an Investigational New Drug Application (IND) for IGM-7354, the Company’s IL-15 x PD-L1 bispecific IgM antibody, in solid tumors in 2022.
IGM-2644 (CD38 x CD3)

IND filing expected in 2022. IGM expects to file an IND for IGM-2644, the Company’s CD38 x CD3 bispecific IgM antibody, in multiple myeloma in 2022.
Corporate Updates

Announced grant agreement with the Bill & Melinda Gates Foundation. The agreement aims to leverage IGM’s engineered IgM and IgA antibodies for the potential prevention of malaria, a significant driver of morbidity and mortality in low- and middle-income countries.

Carrie Brodmerkel, Ph.D., appointed Chief Scientific Officer of IGM Autoimmunity and Inflammation. Dr. Brodmerkel brings extensive experience across a broad range of disciplines to this role. Most recently, she served as Vice President and Global Head of Exploratory Biology and Scientific Strategy at Janssen R&D, a division of Johnson & Johnson, where she was responsible for scientific and strategic leadership of the biotherapeutics portfolio, functional planning and execution, computational sciences, and exploratory biology across therapeutic areas including immunology, hematology, and oncology.
Fourth Quarter and Full Year 2021 Financial Results

Cash and Investments: Cash and investments as of December 31, 2021 were $229.5 million, compared to $366.3 million as of December 31, 2020.
Research and Development (R&D) Expenses: For the fourth quarter and year ended 2021, R&D expenses were $39.2 million and $127.0 million, respectively, compared to $19.6 million and $65.0 million for the fourth quarter and year ended 2020, respectively.
General and Administrative (G&A) Expenses: For the fourth quarter and year ended 2021, G&A expenses were $11.5 million and $38.3 million, respectively, compared to $5.1 million and $18.3 million for the fourth quarter and year ended 2020, respectively.
Net Loss: For the fourth quarter of 2021, net loss was $50.6 million, or a loss of $1.50 per share, compared to a net loss of $24.6 million, or a loss of $0.79 per share, for the fourth quarter of 2020. For the year ended 2021, net loss was $165.2 million, or a loss of $4.93 per share, compared to a net loss of $81.4 million, or a loss of $2.65 per share, for the year ended 2020.
2022 Financial Guidance:
IGM expects full year GAAP operating expenses of $250 million to $260 million including estimated non-cash stock-based compensation expense of approximately $50 million. Concurrent with the Company’s first quarter 2022 financial results expected in May, IGM anticipates providing full year collaboration and license revenue guidance as well as ending 2022 cash and investments guidance.

Conference Call and Webcast
IGM will host a conference call and webcast to discuss the Sanofi R&D collaboration announcement today, March 29, at 8:00 a.m. ET. The conference call may be accessed by dialing (866) 649-1996 (domestic) or (409) 217-8769 (international) and referring to conference ID 4983742. A live webcast of the presentation will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

On March 29, 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 its financial results for the fourth quarter and full year ended December 31, 2021 and provided a corporate update (Press release, CohBar, MAR 29, 2022, View Source [SID1234611114]).

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"2021 was a year of significant growth for CohBar, highlighted by positive topline data from our first human study and the demonstration of clinical proof-of-concept for our platform, the nomination of our second clinical candidate, and the addition of high-quality talent to our leadership and Board," stated Dr. Joseph Sarret, Chief Executive Officer. "As we begin 2022, we are well-positioned to advance our mission and execute on our goals. Today, we announced that we have aligned our resources to focus on three main areas – the development of our IPF program, CB5138-3, the discovery of additional novel peptide families through our novel Mito+ platform, and securing a partner for further development of CB4211. I’m optimistic about this focused strategy and excited for what our team can achieve in 2022 and beyond."

Recent Corporate Updates

●Focused Pipeline to Advance Key Programs: CohBar has aligned its resources to focus on three main areas: (1) the development of its novel peptide analog, CB5138-3, for the treatment of idiopathic pulmonary fibrosis (IPF). In addition to the ongoing IND-enabling studies, the company is focused on optimizing drug delivery to increase the likelihood of success in the clinic for this hard-to-treat patient population. The IND for this program is now expected to be submitted in the second half of 2023; (2) the discovery and development of additional novel peptide families using the company’s novel Mito+ platform; and (3) the pursuit of a partnership for further development of CB4211.

●Appointed Nick Vlahakis, MBBS, as Acting Chief Medical Officer: Today, CohBar announced the appointment of Nick Vlahakis, MBBS, as acting Chief Medical Officer. Dr. Vlahakis is an experienced pulmonary and critical care clinician with clinical development expertise encompassing both early and late stage trials across a wide range of therapeutic areas, including IPF. Before joining CohBar, he was VP and Head of Clinical Development at Global Blood Therapeutics Inc. (GBT) where he advanced voxelotor (Oxbryta) to approval in sickle cell disease. Prior to GBT, he served as the VP and Head of the Respiratory Disease Area at Unity Biotechnology, developing clinical strategy for pre-clinical assets across a broad range of respiratory diseases. Dr. Vlahakis began his industry career at Genentech, serving as clinical lead for products in early and late clinical development. Prior to Genentech, Dr. Vlahakis was on faculty at Mayo Clinic and had an NIH-funded lab studying the biology of fibrosis, acute lung injury and angiogenesis. Dr. Vlahakis received his MBBS medical degree at the University of Adelaide in Australia and completed his Internal Medicine residency and Pulmonary Fellowship at Mayo Clinic. He is also a published scientist with more than 60 peer-reviewed articles.

Fourth Quarter 2021 Highlights

●Announced Changes to its Board of Directors and R&D Leadership. In December 2021, the company announced that its founders Drs. Nir Barzilai, Pinchas Cohen, and John Amatruda transitioned from the Board of Directors to a reconstituted Scientific Advisory Board. In addition, Ken Cundy, Ph.D., resigned as Chief Scientific Officer, effective March 31, 2022, and the company appointed Kent Grindstaff, Ph.D. as Senior Vice President of Research, effective January 4, 2022.

●Completed Equity Financing: In November 2021, the company completed an underwritten public offering of common stock and warrants, with aggregate gross proceeds of approximately $15 million. The company intends to use the proceeds from this offering to fund research and development and other general corporate purposes.

●Presented Late-Breaking Poster on CB4211 at The Liver Meeting 2021: In November 2021, the company presented data from its Phase 1a/1b clinical study of CB4211 during The American Association for the Study of Liver Diseases (AASLD) Annual Meeting (The Liver Meeting 2021).

Fourth Quarter 2021 Financial Highlights

●Cash and Investments: The company had cash and investments of $26.2 million as of December 31, 2021, compared to $21.0 million as of December 31, 2020. The cash burn for the quarter ended December 31, 2021 was approximately $3.0 million.

●R&D Expenses: Research and development expenses were $0.8 million for the three months ended December 31, 2021, compared to $2.7 million in the prior year quarter. The decrease in research and development expenses was primarily due to lower clinical trial and preclinical costs due to the timing of those costs.

●G&A Expenses: General and administrative expenses were $2.0 million for the three months ended December 31, 2021, compared to $1.7 million in the prior year quarter. The increase in general and administrative expenses was primarily due to higher stock-based compensation costs.

●Net Loss: For the three months ended December 31, 2021, net loss, which included $0.6 million of non-cash expenses, was $2.8 million, or $0.04 per basic and diluted share. For the three months ended December 31, 2020, net loss, which included $0.6 million of non-cash expenses, was $4.7 million, or $0.08 per basic and diluted share.

Fourth Quarter and Full-Year 2021 Investor 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.