On March 16, 2023 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported its pipeline and business progress and fourth quarter and full year 2022 financial results (Press release, Nuvalent, MAR 16, 2023, View Source [SID1234628909]).

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"2022 was a remarkable year of progress for Nuvalent. The first half of the year marked our transition to a clinical-stage company with the initiation of dosing in clinical trials for both of our parallel-lead programs, ROS1-selective inhibitor, NVL-520, and ALK-selective inhibitor, NVL-655. The team continued to execute through the second half of the year with our first clinical data presentation demonstrating preliminary clinical proof-of-concept data for NVL-520, as well as the nomination of our third novel development candidate, NVL-330, for HER2 exon 20-positive cancers," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "Going into 2023, we remain committed to following the data and opportunities to carry this positive progress forward. Enrollment continues in the Phase 1 portions of our ARROS-1 and ALKOVE-1 clinical trials, and we continue to progress NVL-330 towards IND as well as pursue further expansion of our discovery pipeline."

Dr. Porter continued, "To have discovered and advanced a pipeline of novel candidates to this point in just a few years from company creation is a testament to our team’s expertise, ability to execute, and commitment to bringing new therapies to patients as quickly as possible. In recognition of their embodiment of these qualities and outstanding contributions to date, we are pleased to promote Dr. Henry Pelish to Senior Vice President, Drug Discovery, and Dr. John Soglia to Senior Vice President, Translational Development. I’m incredibly excited about the future of Nuvalent and believe that with a promising portfolio, dedicated and expert team, and a solid cash position, we are well-positioned to continue advancing towards our goal of delivering precisely targeted therapies for patients with cancer."

Key Achievements

To date, Nuvalent has achieved a number of milestones across its pipeline of novel kinase inhibitors and its research efforts, including:

NVL-520:

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Presented preliminary Phase 1 data supportive of the potential best-in-class profile of NVL-520 as a brain-penetrant, ROS1-selective inhibitor from the ongoing Phase 1/2 ARROS-1 study for patients with advanced ROS1-positive NSCLC and other solid tumors;
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Presented preclinical data supporting the potential for broad clinical utility of NVL-520 across an expanded set of ROS1 fusion partners, resistance mutations, and tumor types beyond NSCLC; and,
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Published the organization’s first manuscript in Cancer Discovery describing the design and characterization of NVL-520 and detailing Nuvalent’s approach to rationally targeting ROS1.

NVL-655:

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Initiated clinical development with parallel-lead candidate, NVL-655, a brain penetrant, ALK-selective inhibitor, in the Phase 1 portion of its ongoing ALKOVE-1 Phase 1/2 study for patients with advanced ALK-positive NSCLC and other solid tumors; and,
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Presented preclinical data in multiple patient derived models that continued to support the potential best-in-class preclinical profile of NVL-655.

Earlier-stage Pipeline:

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Declared a third development candidate, NVL-330, a novel HER2-selective inhibitor for patients with HER2 exon 20 insertion-positive cancers; and,
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Continued to advance pipeline expansion efforts with multiple discovery-stage research programs.

In addition, Nuvalent raised $264.5 million in an upsized public offering and strengthened its leadership with key internal promotions and appointments to its Board of Directors.

Recent Leadership Promotions

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Henry Pelish, Ph.D., Promoted to Senior Vice President, Drug Development: Dr. Pelish contributed to the creation of Nuvalent and joined the company as Biology lead in 2018, bringing over 15 years of experience in cancer biology, chemical biology and organic synthesis. At Nuvalent, Dr. Pelish leads discovery efforts and oversaw the discovery and early-stage development of NVL-520, NVL-655 and NVL-330. Prior to joining Nuvalent, Dr. Pelish was a group leader in the laboratory of Professor Matthew Shair at Harvard University. In that role, he led a team that discovered a new target, mechanism of action and therapeutic opportunity for treatment of acute myeloid leukemia, culminating in a licensing deal and research agreement between Harvard and Merck in 2016. Dr. Pelish earned his Ph.D. in chemistry from Harvard University.
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John Soglia, Ph.D., Promoted to Senior Vice President, Translational Development: Dr. Soglia joined Nuvalent in January 2020 and has since led the strategy and execution of translational development activities of the company’s lead programs, including ADME, nonclinical safety and clinical pharmacology. Prior to Nuvalent, Dr. Soglia was at Decibel Therapeutics where, in addition to leading the DMPK, clinical pharmacology and regulated bioanalytical functions, he was the early Product Development Scientific Lead on the DB-020 program. Previously, he served as head of DMPK at Infinity Pharmaceuticals and was also the eganelisib (IPI-549) product development team leader, successfully leading the cross-functional team to IND submission and into early clinical development. Prior to Infinity Pharmaceuticals, he held various positions of increasing responsibility at GlaxoSmithKline and Pfizer. Dr. Soglia earned his Ph.D. in chemistry from Northeastern University.

Fourth Quarter and Full Year 2022 Financial Results

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Cash Position: Cash, cash equivalents and marketable securities were $472.2 million as of December 31, 2022. Nuvalent believes the existing cash, cash equivalents and marketable securities are expected to be sufficient to fund its current operating plan into the second half of 2025.
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R&D Expenses: Research and development (R&D) expenses were $22.9 million for the fourth quarter of 2022 and $63.7 million for the year ended December 31, 2022, compared to $13.2 million for the fourth quarter of 2021 and $35.6 million for the year ended December 31, 2021.
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G&A Expenses: General and administrative (G&A) expenses were $6.4 million for the fourth quarter of 2022 and $22.4 million for the year ended December 31, 2022, compared to $4.2 million for the fourth quarter of 2021 and $10.3 million for the year ended December 31, 2021.

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Net Loss: Net loss was $26.1 million for the fourth quarter of 2022 and $81.9 million for the year ended December 31, 2022, compared to $17.3 million for the fourth quarter of 2021 and $46.3 million for the year ended December 31, 2021.

On March 16, 2023 NovAccess Global Inc. ("NovAccess," the "company" or "we") reported that it has entered into non-qualified stock option agreements and granted vested ten-year options to purchase shares of the company’s common stock for $0.175 a share, the closing price on the grant date (Filing, 8-K, NovAccess Global, MAR 16, 2023, View Source [SID1234628908]). We issued options to purchase a total of 3,542,857 shares as follows: (a) 857,143 to each of our independent directors, Jason M. Anderson and John A. Cassarini; (b) 428,571 to Neil J. Laird, our chief executive officer, and 571,429 to Dr. Christopher Wheeler, president of our StemVax Therapeutics subsidiary; (c) 57,143 to each of our scientific advisory board members; and (d) the remaining 542,857 to staff members and other officers.

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Item 3.02 Unregistered Sales of Equity Securities.

The disclosure included under Item 1.01 above is incorporated by reference to this Item 3.02. The issuances of the stock options to our independent directors, officers, scientific advisory board members, and staff were exempt from registration under Section 4(a)(2) of the Securities Act of 1933.

On March 16, 2023 Northwest Biotherapeutics presenting its Immunization With Autologous Dendritic Cells is Associated With Extended Survival in Glioblastoma Patients presentation (Presentation, Northwest Biotherapeutics, MAR 16, 2023, View Source [SID1234628907]).

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On March 16, 2023 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported financial results for the fourth quarter and year ended December 31, 2022 (Press release, Nkarta, MAR 16, 2023, View Source [SID1234628906]).

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"Clinical data from our co-lead pipeline candidates have highlighted the promise of our allogeneic NK cell therapy technology to lead the next wave of cell therapy," said Paul J. Hastings, President and CEO of Nkarta. "We believe that the future of cell therapy is improved accessibility, and NK cells may be uniquely equipped to overcome access barriers owing to their intrinsic tumor killing ability and relative ease of administration. We have shown early proof of concept that engineered NK cells derived from healthy donors have the potential to induce deep and meaningful responses in patients without the safety challenges inherent to T-cell based approaches. Nkarta continues to make excellent progress and we look forward to announcing clinical updates for our two programs in 2023."

2022 Pipeline Updates
NKX101

NKX101 is an allogeneic, off-the-shelf cell therapy candidate that uses NK cells derived from healthy donors and engineered to target NKG2D ligands on cancer cells.
In April 2022, Nkarta reported preliminary data from its Phase 1 clinical trial evaluating NKX101 as a multi-dose, multi-cycle monotherapy in patients with r/r acute myeloid leukemia (AML) and higher-risk myelodysplastic syndrome (MDS).
NKX101 demonstrated encouraging single-agent anti-tumor activity. Three of five patients with heavily pre-treated AML treated at the higher dose levels in a three-dose regimen achieved a complete response (60% CR) with hematologic recovery, with two of the three responses MRD (measurable residual disease) negative.
NKX101 was well tolerated. No dose-limiting toxicities were observed. No cytokine release syndrome (CRS), graft-versus-host disease (GvHD), or immune effector cell-associated neurotoxicity syndrome (ICANS) was observed. The most common higher-grade adverse events were myelosuppression and infection, which are common in this patient population following lymphodepletion.
As previously announced, Nkarta plans to present additional results from its ongoing clinical trial of NKX101 in the first half of 2023. The update is expected to include outcomes for the entire cohort of patients with r/r AML treated at 1.5 billion cells/dose x 3 dose regimen.
NKX019

NKX019 is an allogeneic, off-the-shelf cell therapy candidate that uses NK cells engineered to target the B-cell antigen CD19.
In December 2022, Nkarta reported updated preliminary data from its Phase 1 clinical trial evaluating NKX019 as a multi-dose, multi-cycle monotherapy in patients with relapsed/refractory B cell malignancies. Patients were required to be CAR T naïve to avoid confounding either the safety or efficacy of NKX019.
In this update, NKX019 continued to demonstrate encouraging single-agent anti-tumor activity. Seven of ten patients treated at the higher dose levels in a three-dose regimen had a complete response (70% CR), including two of four patients (50% CR) with aggressive large B-cell lymphoma. Five of seven CRs were achieved after a single cycle of treatment. Multiple cycles of treatment enabled deepening of response and consolidation of CR. Durable CRs exceeding beyond 6 months were observed in multiple patients.
No dose limiting toxicity, neurotoxicity / ICANS, GvHD, or Grade 3+ CRS was observed in the study.
In November 2022, Nkarta opened enrollment in the dose expansion portion of its Phase 1 clinical trial of NKX019. The trial is enrolling patients with aggressive LBCL into three cohorts: NKX019 in patients who have not previously received autologous CD19 CAR T therapy, NKX019 in patients who previously received autologous CD19 CAR T therapy, and NKX019 as combination therapy with rituximab to evaluate for enhanced anti-tumor activity via ADCC, a tumor killing mechanism driven by antibodies. The combination arm includes patients who previously received and patients who did not previously receive autologous CD19 CAR T therapy.
As previously announced, Nkarta plans to present updated results from its ongoing clinical trial of NKX019 in 2023. The update is expected to include safety and activity data from patients in the dose escalation cohorts who may have received one or more additional cycles of CAR NK cell therapy, including consolidation therapy, durability of response in patients who were in response as of the November 2022 data cut-off, and safety and activity data from patients treated in the recently opened LBCL dose expansion cohorts.
2022 Platform Updates

In November 2022, Nkarta presented preclinical data from its engineered NK cell platform in two posters at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). The posters included data on improved anti-tumor activity demonstrated by the combination of NKX019 and a CD20-directed monoclonal antibody (mAb) and an optimized manufacturing process that could allow the production of several thousand doses of CAR NK cells from a single manufacturing run.
In April 2022, Nkarta presented preclinical data from its engineered NK cell platform in four posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting. The posters included data on the use of multiplex CRISPR/Cas9 genome editing to enhance the ability of NK cells to target tumors expressing the CD70 antigen (jointly presented with CRISPR Therapeutics); analytical and translational methods to better understand patterns of response to CAR NK cells; analysis of surface antigen expression in preclinical models of multiple myeloma; and immune masking strategies for extending the persistence of allogeneic cell therapies.
2022 Corporate Updates

In August 2022, Nkarta signed amended lease agreements for its future cell therapy manufacturing facility and company headquarters and for its existing facilities. The amendments provide for approximately $15 million of additional tenant improvement allowances for the future facility, increase the rent for the future facility, and increase the rent and term of the lease for some of Nkarta’s existing facilities. These allowances are in addition to the tenant improvement allowances of $25.2 million included in the original lease agreement for the future facility, totaling $40.2 million. Nkarta’s facilities are located in South San Francisco, California.
In April 2022, Nkarta received approximately $215.3 million in net proceeds from a public offering of its common stock.
Fourth Quarter and Full Year 2022 Financial Highlights

Cash and Cash Equivalents: As of December 31, 2022, Nkarta had cash, cash equivalents, restricted cash and short-term investments of $354.9 million.
R&D Expenses: Research and development (R&D) expenses were $90.9 million for the full year 2022 and $26.8 million for the fourth quarter of 2022. Non-cash stock-based compensation expense included in R&D expense was $7.3 million for the full year 2022 and $1.9 million for the fourth quarter of 2022.
G&A Expenses: General and administrative (G&A) expenses were $28.1 million for the full year 2022 and $8.1 million for the fourth quarter of 2022. Non-cash stock-based compensation expense included in G&A expense was $9.5 million for the full year 2022 and $2.5 million for the fourth quarter of 2022.
Net Loss. Net loss was $113.8 million, or $2.61 per basic and diluted share, for the full year 2022. This net loss includes non-cash charges of $23.1 million that consisted primarily of share-based compensation of $16.9 million. Net loss was $32.6 million, or $0.67 per basic and diluted share, for the fourth quarter of 2022.
Financial Guidance

Nkarta expects its current cash and cash equivalents will be sufficient to fund its current operating plan into 2025.
About NKX101
NKX101 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy donors. It is engineered with a chimeric antigen receptor (CAR) targeting NKG2D ligands on tumor cells. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely expressed on cancer cells. NKX101 is also engineered with membrane-bound form of interleukin-15 (IL15) for greater persistence and activity without exogenous cytokine support. To learn more about the NKX101 clinical trial in adults with AML or MDS, please visit ClinicalTrials.gov.

About NKX019
NKX019 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed CAR for enhanced tumor cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal and malignant B cells, and it is a validated target for B cell cancer therapies. To learn more about the NKX019 clinical trial in adults with advanced B cell malignancies, please visit ClinicalTrials.gov.

On March 16, 2023 Monte Rosa Therapeutics, Inc. (NASDAQ: GLUE), a clinical stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported financial results for the fourth quarter and full year ended December 31, 2022, and provided corporate updates (Press release, Monte Rosa Therapeutics, MAR 16, 2023, View Source [SID1234628905]).

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"Last year was transformational for Monte Rosa, as we initiated a Phase 1/2 clinical trial with MRT-2359 for the treatment of MYC-driven solid tumors, and advanced our VAV1 program into lead optimization. We have now shown repeatedly that our QuEEN platform has the ability to generate selective molecular glue degraders for therapeutically relevant protein targets, and our pipeline of unique and differentiated MGDs serves as strong validation of QuEEN," said Markus Warmuth, M.D., CEO of Monte Rosa. "We look forward to presenting the first clinical data for MRT-2359 later this year, as well as nominating multiple development candidates from our pipeline programs. Backed by a strong cash runway, we are well positioned to continue showcasing the unique capabilities of our drug discovery engine and developing new treatment options for patients with serious diseases of high unmet medical need."

Monte Rosa’s current programs are focused on delivering therapies to targets generally considered undruggable or inadequately drugged in well-characterized biological pathways across clinical indications in oncology, inflammation, immunology, and other diseases with high unmet needs. The Company’s lead program, MRT-2359, is in Phase 1/2 clinical trials. Additional programs focused on the degradation of CDK2 for oncology, VAV1 for autoimmunity and NEK7 for inflammation are at the lead optimization stage, with multiple development candidates expected to be announced in 2023. Further discovery programs are focused on sickle cell disease-related proteins, as well as multiple currently undisclosed targets.

Business Highlights and Recent Developments

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Initiated patient dosing in October of its Phase 1/2 clinical trial evaluating MRT-2359 for the treatment of MYC-driven solid tumors, including lung cancer. MRT-2359 is a potent, selective, and orally bioavailable GSPT1-directed MGD, designed to disrupt protein synthesis in MYC-driven tumors and lead to anti-tumor activity. The Phase 1/2 open-label, multicenter study will primarily assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and preliminary clinical activity of MRT-2359 in patients with previously treated selected solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), high-grade neuroendocrine cancer of any primary site, diffuse large B-cell lymphoma (DLBCL) and solid tumors with L-MYC or N-MYC amplification. In the Phase 1 portion of the study, patients are receiving escalating doses of MRT-2359 to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). Once the RP2D is determined, the anti-tumor activity of MRT-2359 will be assessed as part of the
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Phase 2 portion of the study, which includes molecular biomarkers for patient stratification and selection.

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U.S. Food and Drug Administration (FDA) granted Fast Track designation to MRT-2359 in January for the treatment of patients with previously treated, metastatic NSCLC with L-MYC or N-MYC expression. Fast Track designation is designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fulfill an unmet medical need. Clinical programs with Fast Track designation may be eligible for more frequent interactions with the FDA throughout the regulatory review process and may be eligible for Accelerated Approval and Priority Review if relevant criteria are met.

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Advanced immunology-focused VAV1 degrader program into Lead Optimization. VAV1 is a pivotal signal transduction protein in the adaptive immune system. When activated, VAV1 relays a signal cascade that results in immune cell activation and the secretion of several pro-inflammatory cytokines. Prior to Monte Rosa’s research, VAV1 had been considered undruggable. Through analysis and screening by QuEEN, the Company developed highly potent and selective degraders that have been observed to induce rapid and deep VAV1 degradation, elicit expected on-target downstream functional effects and compelling in vivo activity. VAV1 has rapidly advanced into Lead Optimization and is one of three programs that may advance to IND-enabling studies in 2023.

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Strengthened executive leadership team with the promotion of Jennifer Champoux to Chief People & Operations Officer and the appointment of Magnus Walter, Ph.D., to Senior Vice President, Chemical Sciences and Process Development

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Presented at recent scientific and medical conferences including:
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5th Annual Targeted Protein Degradation Summit in Boston, October 25-28, 2022
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34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, October 26-28, 2022
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Molecular Glue Drug Development Summit in Boston, January 25, 2023
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4th Swiss Industrial Chemistry Symposium in Basel, January 27, 2023

2023 Objectives and Upcoming Milestones

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Disclosure of initial clinical data including PK, PD, safety and available initial efficacy data from the Phase 1 arm of the ongoing Phase 1/2 clinical trial evaluating MRT-2359 is expected in the second half of 2023
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Nomination of multiple development candidates from Lead Optimization programs in immunology, inflammation and/or oncology and initiation of IND-enabling studies in 2023
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Disclosure of multiple new discovery programs
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Expand molecular glue degrader platform beyond CRBN

Upcoming Data Presentations

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Additional preclinical data from the MRT-2359 program will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 14-19, 2023, in Orlando, FL; presentation details, as follows:
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Oral Presentation

Title: New Drugs on the Horizon – Discovery of MRT-2359, an orally bioavailable GSPT1 molecular glue degrader, for MYC-driven cancers
Session: New Drugs on the Horizon: Part 3

Presenter: Owen Wallace, Ph.D., Chief Scientific Officer of Monte Rosa
Date and Time: Monday, April 17; 10:15 – 11:45 a.m. ET

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Oral Presentation
Title: Development of MRT-2359, an orally bioavailable GSPT1 molecular glue degrader, for the treatment of lung cancers with MYC-induced translational addiction
Session: Mini Symposium
Abstract: 3449

Presenter: Gerald Gavory, Ph.D., Senior Director of Drug Discovery and Translational Research at Monte Rosa
Date and Time: Monday, April 17; 2:30 – 4:30 p.m. ET

FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS

Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2022 were $24.9 million compared to $18.1 million for the fourth quarter of 2021, and $85.1 million for the year ended December 31, 2022, compared to $57.2 million for the year ended December 31, 2021. The increase in R&D expense was primarily due to the expansion of research and development activities, including the advancement of MRT-2359 into the clinic, pipeline advancement of the VAV1, NEK7 and CDK2 programs, increased headcount and facilities in the United States and Switzerland, and corresponding increases in laboratory-related expenses. R&D expense included non-cash lease expense and non-cash stock compensation expense of $1.6 million and $1.8 million, respectively, for the quarter ended December 31, 2022, and $4.8 million and $6.1 million for the year ended December 31, 2022, respectively. Non-cash stock compensation expense was $1.0 million and $2.6 million for the same periods in 2021

General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2022 were $7.6 million compared to $5.3 million for the fourth quarter of 2021, and $27.3 million for the year ended December 31, 2022, compared to $15.7 million for the year ended December 31, 2021. The increase in G&A expenses were a result of increased headcount and expenses in support of the company’s growth and operations as a public company. G&A expenses included non-cash stock-based compensation of $1.6 million for the fourth quarter of 2022 and $5.6 million for the year ended December 31, 2022, compared to $1.0 million and $2.6 million, respectively, for the same periods in 2021.

Net Loss: Net loss for the fourth quarter of 2022 was $30.8 million compared to $23.4 million for the fourth quarter of 2021, and $108.5 million for the year ended December 31, 2022, compared to $74.0 million for the year ended December 31, 2021.

Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash, and marketable securities as of December 31, 2022, were $268.1 million, compared to $351.4 million as of December 31, 2021. The company expects its cash, cash equivalents, restricted cash and marketable securities will be sufficient to fund planned operations and capital expenditures into 2025.