On May 5, 2022 Tyra Biosciences, Inc. (Nasdaq: TYRA), a precision oncology company focused on developing purpose-built therapies to overcome tumor resistance and improve outcomes for patients with cancer, reported financial results for the quarter ended March 31, 2022 and highlighted recent corporate progress (Press release, Tyra Biosciences, MAY 5, 2022, View Source [SID1234613724]).

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"2022 is off to a great start at TYRA and we continue to focus our efforts on preparing for a successful transition to a clinical-stage company. We look forward to filing INDs for both TYRA-300 and TYRA-200 this year, while continuing to advance our platform and pipeline," said Todd Harris, CEO of TYRA.

First Quarter 2022 and Recent Corporate Highlights

INDs for TYRA-300 and TYRA-200 on Track. TYRA continued to advance TYRA-300, an FGFR3 inhibitor with an initial focus on patients with metastatic urothelial carcinoma of the bladder and urinary tract, and TYRA-200, an FGFR2 inhibitor with an initial focus on patients with intrahepatic cholangiocarcinoma. TYRA remains on track to submit an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) for TYRA-300 in mid-2022 and for TYRA-200 in the second half of 2022.

Pipeline Progression. TYRA continued to progress its pipeline including programs targeting achondroplasia and other FGFR3-related skeletal dysplasias, REarranged during Transfection kinase (RET) and FGFR4-related cancers.
First Quarter 2022 Financial Results

First quarter 2022 net loss was $14.8 million compared to $4.2 million for the same period in 2021.
First quarter 2022 research and development expense was $9.6 million compared to $3.5 million for the same period in 2021.
First quarter 2022 general and administrative expense was $5.2 million compared to $0.7 million for the same period in 2021.
As of March 31, 2022, TYRA had cash and cash equivalents of $292.5 million.

On May 5, 2022 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, Celldex Therapeutics, MAY 5, 2022, View Source [SID1234613751]).

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"This quarter, we continued to focus on advancing our clinical programs and are on track to report data from our chronic spontaneous urticaria Phase 1b study early this summer," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "After successfully completing important readiness activities, including the development of a CDX-0159 subcutaneous formulation, we remain excited to initiate our Phase 2 chronic urticaria programs during the second quarter. We are well-positioned to further build on this positive momentum as we anticipate executing on several other significant key milestones across our pipeline in the year ahead."

Recent Program Highlights

CDX-0159 (also referred to as barzolvolimab) – KIT Inhibitor Program

Barzolvolimab is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells.

Celldex is currently completing enrollment in the Phase 1b multi-center, randomized, double-blind, placebo-controlled study of barzolvolimab in chronic spontaneous urticaria. This study is designed to assess the safety and treatment effects of multiple ascending doses of barzolvolimab in up to 40 patients with chronic spontaneous urticaria who remain symptomatic despite treatment with antihistamines. Data from this study (0.5, 1.5 and 3 mg/kg cohorts) have been submitted for a late breaking presentation at EAACI 2022.

Celldex remains on track to initiate Phase 2 studies in chronic spontaneous urticaria and chronic inducible urticaria (cold urticaria and symptomatic dermographism) in the second quarter of 2022. As previously reported, in the fourth quarter of 2021 and first quarter of this year, Celldex successfully advanced important activities to support the initiation of these studies, including the development of a barzolvolimab subcutaneous formulation and the completion of the in-life dosing portion of a six month chronic toxicology study.

In February 2022, Celldex announced that the development of barzolvolimab will be expanded into eosinophilic esophagitis, the most common type of eosinophilic gastrointestinal disease. Several studies have suggested that mast cells may be an important driver in the disease, demonstrating that the number and activation state of mast cells are greatly increased in eosinophilic esophagitis biopsies and that mast cell signatures correlate with markers of inflammation, fibrosis, pain and disease severity. Given the lack of effective therapies for eosinophilic esophagitis and barzolvolimab’s potential as a mast cell depleting agent, Celldex believes this is an important indication for future study and plans to initiate a Phase 2 trial in the fourth quarter of 2022.

Celldex continues to enroll patients in the Phase 1b multi-center, randomized, double-blind, placebo-controlled study of barzolvolimab in patients with prurigo nodularis, a chronic skin disease characterized by the development of hard, intensely itchy (pruritic) nodules on the skin. Enrollment also remains ongoing in the barzolvolimab Phase 1b open label study in inducible urticaria in a third cohort (single dose, 3 mg/kg) in cholinergic urticaria and a fourth cohort at a lower dose (single dose, 1.5 mg/kg) in cold urticaria.
CDX-1140 – CD40 Agonist Program

CDX-1140 is a potent CD40 human agonist antibody developed by Celldex that the Company believes has the potential to successfully balance systemic doses for good tissue and tumor penetration with an acceptable safety profile.

In the Phase 1 study of CDX-1140 in patients with recurrent, locally advanced or metastatic solid tumors and B cell lymphomas, the monotherapy cohort, the combination cohort with CDX-301 and the safety run-in combination cohort with gemcitabine/nab-paclitaxel have been completed. In late March 2022, Celldex closed enrollment to expansion cohorts in combination with KEYTRUDA (pembrolizumab) in patients with squamous cell head and neck cancer and non-small cell lung cancer who have progressed on checkpoint therapy. Patients in these cohorts continue to be dosed and followed for safety and potential treatment effect.
CDX-527 – Bispecific Antibody Program

CDX-527 is the first candidate developed by Celldex from its bispecific platform which utilizes the Company’s proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway.

In the Phase 1 dose-escalation study of CDX-527 in patients with advanced or metastatic solid tumors that have progressed during or after standard of care therapy, enrollment to the dose escalation portion of the study has been completed and an expansion cohort in ovarian cancer is currently enrolling patients.

First Quarter 2022 Financial Highlights and 2022 Guidance

Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2022 were $380.5 million compared to $408.3 million as of December 31, 2021. The decrease was primarily driven by first quarter cash used in operating activities of $24.5 million. At March 31, 2022, Celldex had 46.8 million shares outstanding.

Revenues: Total revenue was $0.2 million in the first quarter of 2022 compared to $0.7 million for the comparable period in 2021. The decrease in revenue was primarily due to a decrease in services performed under our manufacturing and research and development agreements with Rockefeller University and Gilead Sciences.

R&D Expenses: Research and development (R&D) expenses were $17.1 million in the first quarter of 2022 compared to $12.7 million for the comparable period in 2021. The increase in R&D expense was primarily due to an increase in clinical trial and personnel expenses.

G&A Expenses: General and administrative (G&A) expenses were $6.9 million in the first quarter of 2022 compared to $4.1 million for the comparable period in 2021. The increase in G&A expense was primarily due to higher personnel, legal and commercial planning expenses.

Changes in Fair Value Remeasurement of Contingent Consideration: The gain on fair value remeasurement of contingent consideration was $0.5 million for the first quarter of 2022, primarily due to changes in discount rates.

Net Loss: Net loss was $23.1 million, or ($0.49) per share, for the first quarter of 2022, compared to a net loss of $16.5 million, or ($0.42) per share, for the comparable period in 2021.

Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at March 31, 2022 are sufficient to meet estimated working capital requirements and fund planned operations through 2025.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ USA.

On May 5, 2022 NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, reported financial results for the quarterly period ended March 31, 2022 (Press release, NGM Biopharmaceuticals, MAY 5, 2022, View Source [SID1234613844]).

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"We are pleased with the progress that we have made to date in 2022, in particular with our oncology portfolio, including the advancement of our second myeloid checkpoint inhibitor program, NGM831, into the clinic," said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM Bio. "We plan to deliver several program updates in the second half of the year with multiple milestones expected, including topline Phase 2 data from the CATALINA trial for NGM621, a monoclonal antibody product candidate engineered to potently inhibit complement C3 for patients with geographic atrophy, as well as initial interim monotherapy data from the NGM707 Phase 1 trial and updated data from the Phase 1a/1b trial of NGM120, an antagonist antibody product candidate that binds GFRAL and is designed to inhibit GDF15 signaling, both of which we are developing for the treatment of cancer."

Key First Quarter and Recent Highlights

Oncology

Initiated the Phase 1/1b clinical trial of NGM831 as a monotherapy and in combination with KEYTRUDA for the treatment of patients with advanced solid tumors.
Delivered an oral presentation at the 2022 AACR (Free AACR Whitepaper) annual meeting to showcase in vitro and in vivo research demonstrating potential advantages of dual ILT2/ILT4 inhibition with NGM707 and late-breaking poster presentations to highlight preclinical research supporting development of NGM831 and NGM438.
Retinal Disease

The U.S. Food and Drug Administration granted Fast Track designation to NGM621 for the treatment of patients with geographic atrophy, or GA, secondary to age-related macular degeneration.
Liver and Metabolic Diseases

Completed enrollment in ALPINE 4, the Phase 2b trial of aldafermin, an engineered FGF19 analog product candidate, in patients with compensated NASH cirrhosis (F4 NASH), in January 2022. A topline data readout for ALPINE 4 is expected in the first half of 2023.
Corporate Highlights

Hosted the first two sessions of a four-part virtual R&D overview event titled the "Explorer Series" showcasing NGM Bio’s discovery engine and NGM Bio’s myeloid reprogramming programs, NGM831 and NGM438, both targeting tumor stromal checkpoints.
First Quarter 2022 Financial Results

NGM reported a net loss of $32.5 million for the quarter ended March 31, 2022, compared to a net loss of $27.5 million for the same period in 2021.
Related party revenue from our collaboration with Merck was $20.9 million for the quarter ended March 31, 2022, compared to $21.6 million for the same period in 2021.
R&D expenses were $42.8 million for the quarter ended March 31, 2022, compared to $40.7 million for the same period in 2021. R&D expenses increased $2.1 million in the quarter as compared to the same period in 2021, primarily due to our ongoing clinical trials of NGM621, NGM707, NGM831 and NGM120, our preclinical study of NGM438, and personnel-related expenses partially offset by decreased expenses for our manufacturing activities and our clinical trials of aldafermin.
General and administrative expenses were $10.7 million for the quarter ended March 31, 2022, compared to $8.7 million for the same period in 2021. The $2.0 million increase in general and administrative expenses in the quarter as compared to the same period in 2021 was primarily attributable to compensation-related expenses driven by higher headcount and an increase in expenses associated with being a public company.
Cash, cash equivalents and short-term marketable securities were $329.8 million as of March 31, 2022, compared to $366.3 million as of December 31, 2021.

On May 5, 2022 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing potentially curative therapies leveraging CRISPR-based technologies, reported operational highlights and financial results for the first quarter ended March 31, 2022 (Press release, Intellia Therapeutics, MAY 5, 2022, View Source [SID1234613618]).

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"Intellia is successfully executing on its 2022 strategic priorities as we advance our proprietary CRISPR-based drug discovery and development platform. We recently shared updated interim data from our landmark study of NTLA-2001, which demonstrated that treatment with NTLA-2001 in people with ATTR amyloidosis with polyneuropathy was generally well-tolerated and delivered rapid, consistent, dose-dependent reductions in serum TTR. In addition to achieving a mean reduction of 93% at the 1.0 mg/kg dose, we were particularly pleased that reductions in serum TTR levels persisted, further bolstering our confidence in NTLA-2001 as a potentially durable, one-time treatment for ATTR amyloidosis. In June, we plan to share additional durability data from the dose-escalation portion of the polyneuropathy arm and data supporting our fixed dose selection for Part 2," said Intellia President and Chief Executive Officer John Leonard, M.D. "Alongside the progress of our lead program, we continued to advance our second in vivo candidate, NTLA-2002, which benefits from the modularity of our platform. We look forward to another important clinical milestone in the second half of this year when we expect to present initial data from the NTLA-2002 first-in-human study. Finally, Intellia remains well-funded to drive forward our robust portfolio and to support continued investment in platform innovation as we build upon our leadership position in genome editing."

First Quarter 2022 and Recent Operational Highlights

In Vivo Program Updates

Transthyretin (ATTR) Amyloidosis

NTLA-2001: NTLA-2001 is the first investigational CRISPR-based therapy to be systemically delivered to edit genes inside the human body and has the potential to be the first single-dose treatment for ATTR amyloidosis. Delivered with the Company’s in vivo lipid nanoparticle (LNP) technology, NTLA-2001 offers the possibility of halting and reversing the disease by driving a deep, potentially lifelong reduction in transthyretin (TTR) protein after a single dose. NTLA-2001 is subject to a co-development/co-promotion agreement between Intellia, the lead party for this program, and Regeneron Pharmaceuticals, Inc.

In February, Intellia presented updated interim clinical data from 15 patients with hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN) treated across four single-ascending dose cohorts of the ongoing Phase 1 study. Treatment with NTLA-2001 led to dose-dependent reductions in serum TTR and achieved maximal reductions by day 28, with mean reductions of 86% (n=3) and 93% (n=6) in the 0.7 mg/kg and 1.0 mg/kg dose group, respectively. The maximum TTR reduction was 98% at 1.0 mg/kg. Mean serum TTR reductions were durable through the observation period, with patient follow-up ranging from two to 12 months following a single dose. NTLA-2001 was generally well-tolerated at all dose levels. The most frequent adverse events included headache, infusion-related reactions, back pain, rash and nausea.
Based on these data, Intellia is evaluating a fixed dose of 80 mg in Part 2 of the Phase 1 study, which is expected to deliver a similar exposure to the 1.0 mg/kg dose. The Company announced today that the first patient has been dosed in Part 2, a single-dose expansion cohort, in the polyneuropathy arm.
The Company plans to present additional interim data from Part 1, the single-ascending dose portion, of the polyneuropathy arm at the European Association for the Study of the Liver (EASL) International Liver Congress 2022, to be held June 22-26.
Intellia also continues to dose patients in the cardiomyopathy arm of its expanded Phase 1 study, which is currently evaluating NTLA-2001 in dose-escalation cohorts of patients with ATTR amyloidosis with cardiomyopathy (ATTR-CM). The Company’s goal is to present the first interim data from the cardiomyopathy arm in the second half of 2022. Enrollment across both ATTRv-PN and ATTR-CM patient populations is expected to complete in 2022.
Hereditary Angioedema (HAE)

NTLA-2002: NTLA-2002 leverages Intellia’s proprietary in vivo LNP delivery technology to knock out the KLKB1 gene in the liver with the potential to permanently reduce total plasma kallikrein protein and activity, a key mediator of HAE. This investigational approach aims to prevent attacks for people living with HAE by providing continuous reduction of plasma kallikrein activity following a single dose and to eliminate the significant treatment burden associated with currently available HAE therapies.

Intellia is progressing the single-ascending dose portion of its Phase 1/2 study evaluating the safety, tolerability and activity of NTLA-2002 in adults with Type I or Type II HAE. The Company has completed dosing in the first dose-escalation cohort (25 mg fixed dose) and has begun enrolling patients in the second dose-escalation cohort (75 mg fixed dose).
The Company anticipates presenting interim data in the second half of 2022 from the first-in-human study, with initial results expected to characterize the emerging safety and activity profile of NTLA-2002, and potentially demonstrate preliminary proof-of-concept.
Alpha-1 Antitrypsin Deficiency (AATD)

NTLA-3001 for associated lung disease: NTLA-3001 is a wholly owned, first-in-class CRISPR-mediated in vivo targeted gene insertion development candidate for the treatment of AATD-associated lung disease. It is designed with the aim to precisely insert a healthy copy of the SERPINA1 gene, which encodes the alpha-1 antitrypsin (A1AT) protein, with the potential to restore permanent expression of functional A1AT protein to therapeutic levels after a single dose. This approach seeks to improve patient outcomes, including eliminating the need for weekly IV infusions of A1AT augmentation therapy or lung transplant in severe cases.

Intellia is conducting Investigational New Drug (IND)-enabling activities for NTLA-3001, with plans to file an IND or IND-equivalent in 2023.
NTLA-2003 for associated liver disease: NTLA-2003 is a wholly owned in vivo knockout development candidate for the treatment of AATD-associated liver disease. It is designed to inactivate the SERPINA1 gene responsible for the production of abnormal A1AT protein in the liver. This approach aims to halt the progression of liver disease and eliminate the need for liver transplant in severe cases.

Intellia is initiating IND-enabling activities for NTLA-2003.
Ex Vivo Program Updates

Acute Myeloid Leukemia (AML)

NTLA-5001: NTLA-5001 is an investigational autologous T cell receptor (TCR)-T cell therapy engineered to target the Wilms’ Tumor 1 (WT1) antigen for the treatment of all genetic subtypes of AML.

In March, Intellia announced the first patient was dosed in its Phase 1/2a study evaluating NTLA-5001 for the treatment of AML. The Company continues to enroll patients in the ongoing study.
In March, Intellia announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to NTLA-5001 for the treatment of AML.
CD30+ Lymphomas

NTLA-6001: NTLA-6001 is a wholly owned, allogeneic CAR-T development candidate targeting CD30 for the treatment of CD30-expressing hematologic cancers, including relapsed or refractory classical Hodgkin lymphoma (cHL). NTLA-6001 is the first candidate developed using Intellia’s proprietary allogeneic cell engineering platform, which leverages a novel combination of sequential gene edits to protect T cells from immune rejection by both host T and natural killer (NK) cells.

Intellia is initiating IND-enabling activities for NTLA-6001.
At the 2022 Keystone Symposia’s Precision Genome Engineering Conference, Intellia presented preclinical data leading to the development of NTLA-6001. The data demonstrated that Intellia’s proprietary allogeneic solution created T cells that not only avoided immune recognition by host CD4 and CD8 T cells, but also were protected from NK cell-mediated killing in in vitro and in vivo mouse models. Furthermore, allogeneic T cells engineered sequentially with LNPs retained high viability, cell expansion, memory phenotype, cytotoxic and cytokine secretion characteristics.
Research and Corporate Updates

Modular Platform and Pipeline Expansion: Intellia is expanding its industry-leading genome editing platform and scientific leadership through editing, delivery and cell engineering innovations that may enable broader in vivo and ex vivo applications.

Intellia plans to advance at least one additional new in vivo development candidate by the end of 2022.
The Company plans to highlight additional advances to its proprietary technology capabilities, including both genome editing and delivery tools, at upcoming scientific conferences in 2022.
Collaboration Updates

In February, Intellia announced a collaboration agreement with ONK Therapeutics Ltd. for the development of allogeneic CRISPR-edited NK cell therapies for the treatment of cancer.
In January, Intellia announced a licensing and collaboration agreement with Kyverna Therapeutics, Inc. for the development of KYV-201, an allogeneic CD19 CAR-T cell investigational candidate for the treatment of select autoimmune diseases.
Corporate Updates

In May, Intellia announced the appointment of Muna Bhanji, R.Ph., to its Board of Directors. Ms. Bhanji brings more than 30 years of strategic and operational experience in the biopharmaceutical industry to Intellia’s board, including a proven track record of driving growth across a broad portfolio of medicines and vaccines.
In February, Intellia completed the acquisition of Rewrite Therapeutics, Inc. (Rewrite), a private biotechnology company focused on advancing novel DNA writing technologies. Rewrite’s DNA writing technology may enable a range of editing strategies, including targeted corrections, insertions, deletions and the full range of single-nucleotide changes.
In February, Intellia announced a lease agreement to develop a 140,000-square-foot manufacturing facility in Waltham, Massachusetts, to support the manufacturing of key components for its CRISPR-based investigational therapies. The new manufacturing facility will be Good Manufacturing Practice compliant and support the preclinical through commercial supply for key components of Intellia’s CRISPR-based therapies.
Upcoming Events

The Company will participate in the following events during the second quarter of 2022:

RBC Capital Markets Global Healthcare Conference, May 17, New York
Jefferies Healthcare Conference, June 9, New York
EASL International Liver Congress 2022, June 22-26, London
Upcoming Milestones

The Company has set forth the following for pipeline progression:

In Vivo

NTLA-2001 for ATTR amyloidosis:

Report additional interim data from ATTRv-PN arm of Phase 1 study in June 2022
Present interim data from ATTR-CM arm of Phase 1 study in 2H 2022
Complete enrollment of Phase 1 study for both ATTRv-PN and ATTR-CM subjects in 2022
NTLA-2002 for HAE: Present interim data from Phase 1/2 study in 2H 2022
NTLA-3001 for AATD: File an IND or IND-equivalent in 2023
Advance at least one additional new in vivo development candidate by the end of 2022
Ex Vivo

NTLA-5001 for AML: Continue to enroll patients in Phase 1/2a study in 2022
Modular Platform

Advance additional novel platform capabilities in 2022
First Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $994.7 million as of March 31, 2022, compared to $1.1 billion as of December 31, 2021. The decrease was driven by cash used to fund operations of approximately $95.7 million as well as the acquisition of Rewrite for $45.0 million. The decrease was offset in part by $38.9 million in net equity proceeds raised from the Company’s "At the Market" (ATM) agreement and $8.4 million in proceeds from employee-based stock plans.
Collaboration Revenue: Collaboration revenue increased by approximately $4.8 million to $11.3 million during the first quarter of 2022, compared to $6.4 million during the first quarter of 2021. The increase was primarily driven by our joint venture with AvenCell.
R&D Expenses: Research and development expenses increased by $93.8 million to $133.1 million during the first quarter of 2022, compared to $39.3 million during the first quarter of 2021. This increase was primarily driven by $56.0 million of expense related to the acquisition of Rewrite, which includes a $45.0 million upfront payment and $10.5 million related to a potential stock-based earnout payment. The remaining $37.8 million was driven by the advancement of our lead programs, research personnel growth to support these programs, and expansion of the development organization.
G&A Expenses: General and administrative expenses increased by $8.8 million to $22.4 million during the first quarter of 2022, compared to $13.6 million during the first quarter of 2021. This increase was primarily related to employee related expenses, including stock-based compensation of $5.3 million.
Net Loss: The Company’s net loss was $146.9 million for the first quarter of 2022, compared to $46.2 million during the first quarter of 2021.
Conference Call to Discuss First Quarter 2022 Results

The Company will discuss these results on a conference call today, Thursday, May 5, at 8 a.m. ET.

To join the call:

U.S. callers should dial 1-833-316-0545 and international callers should dial 1-412-317-5726, approximately five minutes before the call. All participants should ask to be connected to the Intellia Therapeutics conference call.

Please visit this link for a simultaneous live webcast of the call.
A replay of the call will be available through the Events and Presentations page of the Investors & Media section on Intellia’s website at intelliatx.com, beginning on May 5, at 12 p.m. ET.

On May 5, 2022 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its financial results for the first quarter ended March 31, 2022 and provided business updates (Press release, Curis, MAY 5, 2022, View Source [SID1234613647]).

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"During the first quarter of 2022, we continued to advance the clinical trials of emavusertib, previously referred to as CA-4948, our first-in-class, small molecule IRAK4 inhibitor in nine distinct patient populations across AML, MDS and B cell cancers. In January, we provided additional preliminary data showing early anti-cancer activity of emavusertib in AML/MDS patients with spliceosome or FLT3 mutation. In addition, we presented initial data from the dose escalation study of CI-8993, a monoclonal antibody targeting VISTA, in patients with relapsed/refractory solid tumors. We also would highlight that we have cleared the 0.3mg/kg dose level, which we believe is an important initial safety hurdle," said James Dentzer, President and Chief Executive Officer of Curis.

"Shortly after the close of the first quarter, our two TakeAim studies were put on partial clinical hold by the U.S. Food and Drug Administration ("FDA") as the agency is seeking additional data relating to emavusertib, including data related to rhabdomyolysis and our determination of the Recommended Phase 2 Dose. We are working collaboratively with the FDA and hope to resolve the partial hold on our studies quickly," continued Mr. Dentzer. "As we gain clarity on the timing of this resolution, we will provide updated guidance on our plan to discuss the potential for a rapid registrational path for emavusertib with the FDA."

First Quarter 2022 and Recent Operational Highlights

Precision oncology, emavusertib (IRAK4 Inhibitor; Aurigene collaboration):

In January, the company hosted a conference call detailing updated data from the TakeAim Leukemia study.
The TakeAim Leukemia study is a Phase 1/2 dose escalation, dose expansion study examining emavusertib use as both monotherapy and in combination with azacitidine or venetoclax in patients with relapsed or refractory ("R/R") acute myeloid leukemia ("AML") or R/R high risk myelodysplastic syndrome ("MDS").
In patients with spliceosome-mutated R/R AML, key findings included:
CR/CRh rate of 40% (2 out of 5 patients)
Both patients who achieved CR/CRh have been on study > 6 months and achieved negative MRD (minimal residual disease) status
Consistent tumor burden reduction observed, 3 out of 5 patients with elevated blast counts achieving ≥ 50% reduction in blast counts
In patients with spliceosome-mutated R/R MDS, key findings included:
Objective response rate of 57% (4 out of 7 patients)
One of the patients who achieved a marrow CR ("mCR") proceeded to stem cell transplant after 1 cycle
Consistent tumor burden reduction observed, with 4 out of 6 patients with elevated baseline blast counts achieving ≥ 50% reduction in blast counts
In patients with a FLT3 mutated R/R AML, key findings included:
CR rate of 33% (1 out of 3 patients; this patient’s AML also had a spliceosome mutation)
2 out of 3 patients showed eradication of FLT3 mutation following treatment, indicating potential for disease modification with emavusertib
Consistent tumor burden reduction observed; with 2 out of 3 patients with elevated blast counts achieving ≥ 50% reduction in blast counts
Curis collaborators at the Washington University School of Medicine in St. Louis, published research suggesting the potential use of emavusertib in solid tumors, such as pancreatic cancer, a setting with very limited therapeutic options.
The manuscript titled "IRAK4 signaling drives resistance to checkpoint immunotherapy in pancreatic ductal adenocarcinoma" concluded that tumor IRAK4 drives T-cell exhaustion in pancreatic nonclinical ductal adenocarcinoma models and is a promising therapeutic target when combined with checkpoint immunotherapy.
The manuscript is available online at View Source(22)00201-3/pdf.
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext collaboration):

Also discussed during the January update call were data from the Phase 1 study of CI-8993, Curis’s first-in-class monoclonal anti-VISTA antibody, in patients with R/R solid tumors.
Dose escalation has proceeded to the 0.6mg/kg dose level, past the 0.15mg/kg dose level where toxicities were seen previously, namely cytokine release syndrome, or CRS. Dose escalation will continue until the Recommended Phase 2 Dose ("RP2D") has been determined
Pharmacodynamic data suggest CI-8993 has multiple anticancer mechanisms that may position it for combination with existing checkpoint inhibitors, in addition to monotherapy
Presentations at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

Curis Presentations

TakeAim Lymphoma
Abstract Number: 7575
Abstract Title: Open-label, dose-escalation, and expansion trial of CA-4948 in combination with ibrutinib in patients with relapsed or refractory hematologic malignancies.
Session Type/Title: Poster Session/ Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Session Date and Time: Saturday, June 4, 2022, 8:00 AM-11:00 AM CDT
TakeAim Leukemia
Abstract Number: 7016
Abstract Title: Phase 1/2a study of the IRAK4 inhibitor CA-4948 as monotherapy or in combination with azacitidine or venetoclax in patients with relapsed/refractory (R/R) acute myeloid leukemia or myelodysplastic syndrome.
Session Type/Title: Poster Discussion Session/ Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Session Date and Time: Saturday, June 4, 2022, 1:15 PM-2:45 PM; 8:00 AM-11:00 AM CDT
Collaborator Presentations

Gastric and Esophageal Cancer
Abstract Number: TPS4168
Abstract Title: Phase I trial of CA-4948, an IRAK4 inhibitor, in combination with FOLFOX/PD-1 inhibitor +/- trastuzumab for untreated unresectable gastric and esophageal cancer
Session Type/Title: Poster Session/Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date and Time: Saturday, June 4, 2022, 8:00 AM-11:00 AM CDT
Melanoma Brain Metastases
Abstract Number: 2011
Abstract Title: CA-4948 for the treatment of melanoma brain metastasis.
Session Type/Title: Poster Discussion Session/ Central Nervous System Tumors
Session Date and Time: Sunday, June 5, 2022, 11:30 AM-1:00 PM; 8:00 AM-11:00 AM CDT
Upcoming Planned Milestones for 2022

Report data from the TakeAim Lymphoma study
In the first half of 2022, we plan to present new data for approximately 12 patients who have received treatment with the combination of emavusertib and ibrutinib at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") and European Hematology Association (EHA) (Free EHA Whitepaper) ("EHA") meetings in June 2022
Report data from the TakeAim Leukemia study
In the first half of 2022, we plan to present the monotherapy data released on our January update call in a peer-reviewed setting at the ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) conferences
In the second half of 2022, we plan to present an update with additional monotherapy data
In the second half of 2022, we plan to present initial data for the study of emavusertib in combination with azacitadine or venetoclax
Report data from the CI-8993 (VISTA checkpoint inhibitor) study
In the second half of 2022, we plan to present an update with additional monotherapy data
First Quarter 2022 Financial Results

For the first quarter of 2022, Curis reported a net loss of $16.1 million or $0.18 per share on both a basic and diluted basis, as compared to a net loss of $9.9 million, or $0.11 per share on both a basic and diluted basis for the same period in 2021.

Revenues for the first quarter of 2022 and 2021 were $2.1 million and $2.2 million, respectively. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.

Operating expenses for the first quarter of 2022 were $17.2 million, as compared to $11.0 million for the same period in 2021, and comprised the following:

Cost of Royalty Revenues. Cost of royalty revenues, represents amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.1 million for the first quarter of 2022 and 2021.

Research and Development Expenses. Research and development expenses were $11.4 million for the first quarter of 2022 as compared to $6.8 million for the same period in 2021. The increase in direct research and development expenses for the quarter is primarily attributable to increased manufacturing costs for our programs and increased consulting services. Additionally, personnel related costs increased by $2.4 million and stock compensation increased $0.4 million, primarily as a result of additional headcount.

General and Administrative Expenses. General and administrative expenses were $5.7 million for the first quarter of 2022, as compared to $4.1 million for the same period in 2021. The increase in general and administrative expense was driven primarily by higher costs for personnel, stock-based compensation, and insurance costs.

Other Expense, Net. For the third quarter of 2022 and 2021, net other expense was $1.0 million and $1.1 million, respectively. Net other expense primarily consisted of imputed interest expense related to future royalty payments.

As of March 31, 2022, Curis’s cash, cash equivalents and investments totaled $120.7 million, and there were approximately 91.6 million shares of common stock outstanding. Curis expects that its existing cash, cash equivalents and investments should enable it to maintain its planned operations into 2024.

Conference Call Information

Curis management will host a conference call today, May 5, 2022, at 4:30 p.m. ET, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.