On May 9, 2024 PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, reported financial results for the first quarter ended March 31, 2024, and provided a corporate update (Press release, PMV Pharma, MAY 9, 2024, View Source [SID1234643013]).

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"Dosing the first patient in the registrational, tumor-agnostic Phase 2 portion of the PYNNACLE trial is an important milestone for PMV. Our team has worked diligently to initiate this global trial and I would like to thank them for their efforts," said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. "Rezatapopt offers the potential to provide a new treatment option for patients with a TP53 Y220C mutation and KRAS wild-type advanced solid tumors."

Corporate Highlights:

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First patient dosed in Phase 2 portion of the PYNNACLE trial. The multi-center, single-arm, registrational, tumor-agnostic Phase 2 trial will assess rezatapopt as monotherapy at a dose of 2000 mg once-daily in patients with TP53 Y220C and KRAS wild-type advanced solid tumors. The primary endpoint of the trial is overall response rate per blinded independent central review. The trial is designed to enroll 114 patients across five cohorts at approximately 60 sites across the U.S., Europe, and Asia-Pacific.
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Phase 1 data of rezatapopt in advanced ovarian cancer was featured in a late-breaking oral presentation at the 2024 SGO Annual Meeting on Women’s Cancer. Of the 15 heavily pre-treated patients with advanced ovarian cancer harboring a TP53 Y220C mutation, seven patients achieved a confirmed partial response with a seven-month median duration of response and a favorable safety profile.

First Quarter 2024 Financial Results

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PMV Pharma ended the first quarter with $213.1 million in cash, cash equivalents, and marketable securities, compared to $228.6 million as of December 31, 2023. Net cash used in operations was $16.2 million for the three months ended March 31, 2024, compared to $15.0 million for the three months ended March 31, 2023.
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Net loss for the quarter ended March 31, 2024, was $15.3 million compared to $19.1 million for the quarter ended March 31, 2023.
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Research and development (R&D) expenses were $13.2 million for the quarter ended March 31, 2024, compared to $15.1 million for the quarter ended March 31, 2023. The decrease in R&D expenses was primarily related to decreased contractual research organization costs, offset by increased personnel related costs and stock-based compensation.
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General and administrative (G&A) expenses were $5.0 million for the quarter ended March 31, 2024, compared to $6.4 million for the quarter ended March 31, 2023. The decrease in G&A expenses was primarily due to reduced spend for facility and operational expenses.

About Rezatapopt

Rezatapopt (PC14586) is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein, restoring the wild-type tumor-suppressor function. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation.

About the PYNNACLE Clinical Trial

The ongoing Phase 1/2 PYNNACLE clinical trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation. The primary objective of the Phase 1 portion of the trial was to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of rezatapopt when administered orally to patients. Safety, tolerability, pharmacokinetics and effects on biomarkers were also assessed. The Phase 2 portion is a registrational, single arm, expansion basket clinical trial comprising five cohorts (ovarian, lung, breast, and endometrial cancers, and other solid tumors) with the primary objective of evaluating the efficacy of rezatapopt at the RP2D in patients with TP53 Y220C and KRAS wild-type advanced solid tumors. For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750).

On May 9, 2024 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported a business update and announced first quarter 2024 financial results (Press release, Oncternal Therapeutics, MAY 9, 2024, View Source [SID1234643012]).

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"We are encouraged by the fast pace of execution for our clinical programs, and we are looking forward to important clinical data readouts in the coming months. Our Phase 1/2 study of ONCT-534 in patients with R/R mCRPC has advanced swiftly through the initial dose escalation cohorts and we are optimistic, based on preclinical data, that the 300 mg dose may be within the active dose range for antitumor activity. We believe that the novel mechanism of action of ONCT-534, which includes interaction with both the N-terminal and ligand-binding domains of the AR has the potential to address important unmet needs of prostate cancer patients who have progressed after treatment with approved AR pathway inhibitors," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "Our ROR1 CAR T Phase 1/2 study is now open and enrolling patients after implementing protocol amendments. We continue to be encouraged by the initial response signals we observed, and we look forward to reporting additional clinical data in patients with relapsed or refractory aggressive B cell lymphoma, including those who have relapsed after CD19 CAR T treatment."

Recent Highlights

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In April 2024, we announced that the first patient had been dosed in the fourth cohort of our Phase 1/2 study of ONCT-534 for the treatment of patients with advanced prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors (ARPI). Patients in the fourth dosing cohort will receive 300 mg of ONCT-534 taken orally each day. The fourth cohort is now fully enrolled with three subjects treated.
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Our dose escalation/dose expansion Phase 1/2 Study ONCT-808-101, evaluating our ROR1-targeting autologous CAR T cell therapy, ONCT-808, for the treatment of patients with relapsed or refractory aggressive B-cell lymphoma, is open and enrolling patients. Protocol changes that include modified eligibility criteria, increased monitoring for early infection, and evaluating lower doses have now been implemented.

Expected Upcoming Milestones

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ONCT-534, our dual-action androgen receptor inhibitor
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Initial clinical data update in the second quarter of 2024
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Additional clinical data readouts in the fourth quarter of 2024
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ONCT-808, our autologous ROR1-targeted CAR T cell therapy
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Clinical data update in mid-2024
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Additional clinical data readouts in the fourth quarter of 2024
First Quarter 2024 Financial Results

Our grant revenue was $0.6 million for the first quarter ended March 31, 2024. Our total operating expenses for the first quarter ended March 31, 2024 were $9.3 million, including $1.4 million in non-cash stock-based compensation expense. Research and development expenses for the quarter totaled $6.0 million, and general and administrative expenses for the quarter totaled $3.3 million. Net loss for the first quarter was $8.4 million, or a net loss of $2.83 per share, basic and diluted. As of March 31, 2024, we had approximately 3.0 million shares of common stock outstanding, $27.0 million in cash, cash equivalents and short-term investments and no debt. These funds are expected to be sufficient to fund our operations into the first quarter of 2025.

On May 9, 2024 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pipeline progress, reiterated key anticipated milestones, and reported first quarter 2024 financial results (Press release, Nuvalent, MAY 9, 2024, View Source [SID1234643011]).

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"Guided by our OnTarget 2026 operating plan, 2024 is a year of focused execution on our path towards a potential first approval in 2026 from our pipeline of novel kinase inhibitors," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "We expect to share clinical updates from our parallel lead programs for ROS1-positive and ALK-positive NSCLC at a medical meeting in the second half of the year and are on-track to dose the first patient in our HER2 program this year. This is an important time for Nuvalent, and we are excited to carry this momentum forward in hopes of bringing our therapies to patients as efficiently as possible."

Recent Pipeline Progress and Anticipated Milestones

ROS1 Program

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Nuvalent presented new preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrating that zidesamtinib, its novel ROS1-selective inhibitor, was effective at suppressing on-target ROS1 resistance mutations in preclinical mutagenesis screens.
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The company expects to share updated data from the ARROS-1 Phase 1/2 trial at a medical meeting in the second half of 2024. Enrollment is ongoing in the global Phase 2 portion of the study.
ALK Program

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Enrollment is ongoing in the global Phase 2 portion of the ALKOVE-1 trial of NVL-655 for patients with advanced ALK-positive NSCLC and other solid tumors. The Phase 2 cohorts are designed with registrational intent for TKI pre-treated patients with ALK-positive NSCLC and to enable preliminary evaluation in patients with ALK-positive NSCLC who are TKI naïve.
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The company expects to share updated data from the ALKOVE-1 trial at a medical meeting in the second half of 2024. Additionally, Nuvalent plans to outline its broader front-line development strategy for its ALK program in 2024.
HER2 Program

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Nuvalent presented new preclinical data at AACR (Free AACR Whitepaper) supporting the broad activity against HER2 oncogenic alterations, selectivity over wild-type EGFR, and differentiated brain-penetrant profile of its novel HER2-selective inhibitor, NVL-330.
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The company expects to initiate the Phase 1 trial for its HER2 program in 2024.

Upcoming Events

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TD Cowen 5th Annual Oncology Innovation Summit:Management will be participating in a virtual fireside chat on May 29, 2024 at 9:30 am ET. A live webcast will be available in the Investors section of Nuvalent’s website at www.nuvalent.com, and will be archived for 30 days following the conference.

First Quarter 2024 Financial Results

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Cash Position: Cash, cash equivalents and marketable securities were $691.8 million as of March 31, 2024. Nuvalent believes these existing cash, cash equivalents and marketable securities to be sufficient to fund its current operating plan into 2027.
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R&D Expenses: Research and development (R&D) expenses were $38.6 million for the first quarter of 2024.
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G&A Expenses: General and administrative (G&A) expenses were $14.0 million for the first quarter of 2024.
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Net Loss: Net loss was $44.5 million for the first quarter of 2024.

About OnTarget 2026

OnTarget 2026 delineates Nuvalent’s 3-year operating plan towards bringing new, potential best-in-class medicines to patients with cancer. As part of this plan announced in January 2024, Nuvalent outlined the following anticipated milestones throughout 2024, leading to the company’s first potential pivotal data in 2025 and first potential approved product in 2026:

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2024: Execute on Global Registrational Strategies
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Progress the Phase 2 portion of its ARROS-1 trial of zidesamtinib in patients with advanced ROS1-positive NSCLC with registrational intent;
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Initiate the Phase 2 portion of its ALKOVE-1 trial of NVL-655 in patients with advanced ALK-positive NSCLC with registrational intent;
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Launch the front-line development strategy for its ALK program;
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Present interim data from its ongoing ARROS-1 and ALKOVE-1 clinical trials at medical meetings; and,
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Initiate the Phase 1 trial for its HER2 program.
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2025: First Pivotal Data
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2026: First Approved Product

On May 9, 2024 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies, reported financial results for the first quarter ended March 31, 2024 (Press release, Nkarta, MAY 9, 2024, View Source [SID1234643010]).

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"Cell therapy has the potential to transform the way people living with autoimmune diseases are treated," said Paul J. Hastings, President and CEO of Nkarta. "We believe that an off-the-shelf, targeted NK-cell product like NKX019 could address the infrastructure and safety concerns that have created barriers to patient access across our industry. We are excited to dose patients with NKX019 in lupus nephritis, and we look forward to giving an update in the coming months, including our plans for evaluating other autoimmune diseases."

NKX019 in autoimmune disease

NKX019 is an allogeneic, off-the-shelf cell therapy candidate comprising NK cells derived from healthy donors and engineered to target the B-cell antigen CD19 for patients with B-cell mediated diseases.
The Phase 1 multi-center, dose-escalation clinical trial will assess the safety and clinical activity of NKX019 in patients with refractory lupus nephritis (LN). Per the protocol, patients receive a three-dose cycle of NKX019 following single-agent lymphodepletion (LD) comprising only cyclophosphamide (cy), an agent with an established safety profile in systemic lupus erythematosus (SLE) and LN.
The Investigational New Drug (IND) Application for LN cleared in 4Q 2023.
Translational data support the potential for NKX019 to drive immunologic reset, including efficient killing of B cells from patients with autoimmune disease and recovery of predominantly naïve B cells following treatment with NKX019 for B-cell malignancies.
Nkarta expects to provide an update on first patient dosing for NKX019 in LN in the first half of 2024. The announcement is also expected to feature plans for the evaluation of NKX019 in additional autoimmune diseases.
NKX019 in non-Hodgkin lymphoma (NHL)

Nkarta reported in January 2024 that 4 of 4 patients with relapsed/refractory (r/r) NHL that relapsed after achieving complete response (CR) following treatment with NKX019 were again able to achieve CR after re-treatment with NKX019. These outcomes suggest that relapse, when it occurs, may be attributable to mechanisms of NKX019 exposure and not resistance to NKX019.
In the Phase 1 study of NKX019 in r/r NHL, patients receive NKX019 doses on Days 0, 3 and 7 following LD with fludarabine (flu) and cy. This compressed dosing regimen is designed to intensify exposure of NKX019 by dosing closer to LD. In addition, patients with ongoing cytopenias have the potential to receive NKX019 following LD with cy alone.
Nkarta expects to announce preliminary data from the NKX019 compressed dosing cohort in mid-2024.
Other Corporate Highlights

In March 2024, Nkarta completed an underwritten offering of common stock and pre-funded warrants with gross proceeds of $240.1 million. New and existing investors participated in the offering.
First Quarter 2024 and Recent Financial Highlights

Nkarta had cash, cash equivalents, restricted cash, and investments in marketable securities of $450.0 million as of March 31, 2024.
Research and development (R&D) expenses were $25.2 million for the first quarter of 2024. Non-cash stock-based compensation expense included in R&D expense was $2.2 million for the first quarter of 2024.
General and administrative (G&A) expenses were $7.5 million for the first quarter of 2024. Non-cash stock-based compensation expense included in G&A expense was $2.2 million for the first quarter of 2024.
Net loss was $29.5 million, or $0.58 per basic and diluted share, for the first quarter of 2024. This net loss includes non-cash charges of $5.6 million that consisted primarily of share-based compensation and depreciation expenses.
Financial Guidance

Nkarta expects its current cash and cash equivalents will be sufficient to fund its current operating plan into late 2027.
About NKX019
NKX019 is an allogeneic, cryopreserved, off-the-shelf 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 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 B cells as well as those implicated in autoimmune disease and B cell-derived malignancies.

On May 9, 2024 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the first quarter ended March 31, 2024 (Press release, Nektar Therapeutics, MAY 9, 2024, View Source [SID1234643009]).

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Cash and investments in marketable securities at March 31, 2024 were $326.0 million as compared to $329.4 million at December 31, 2023. Nektar’s cash and marketable securities are expected to support strategic development activities and operations into the third quarter of 2026.

"In the first quarter, we made significant progress with our highly promising immunology and inflammation pipeline," said Howard W. Robin, President and CEO of Nektar. "REZPEG is advancing in the clinic in our Phase 2b study in patients with atopic dermatitis and in our Phase 2b study in patients with alopecia areata. Enrollment for both studies is on-track, and we expect to report topline data from these trials in the first half of 2025. Building out our Treg pipeline, our novel bivalent antibody targeting the TNFR2 receptor is progressing through IND-enabling studies to support entering the clinic next year."

Summary of Financial Results

Revenue in the first quarter of 2024 was $21.6 million as compared to the same $21.6 million in the first quarter of 2023.

Total operating costs and expenses in the first quarter of 2024 were $57.1 million as compared to $156.3 million in the first quarter of 2023. Operating costs and expenses for the first quarter of 2023 included a one-time $76.5 million non-cash goodwill impairment charge. Operating costs and expenses for the first quarter of 2024 further decreased as compared to 2023 due to decreases in restructuring, impairment and costs of terminated program, as well as decreases in R&D and G&A expense.

R&D expense in the first quarter of 2024 was $27.4 million as compared to $30.5 million for the first quarter of 2023. R&D expense for the first quarter of 2024 decreased primarily due to a decrease in employee costs and related facilities costs, partially offset by an increase in expense for the development of rezpegaldesleukin and NKTR-0165, our TNFR2 agonist antibody.

G&A expense was $20.1 million in the first quarter of 2024 as compared to $21.1 million in the first quarter of 2023.

Restructuring, impairment and other costs of the terminated program were $1.0 million in the first quarter of 2024 as compared to $21.2 million in the first quarter of 2023. Restructuring, impairment and other costs of terminated program decreased primarily due to $13.2 million in non-cash lease and equipment impairment charges and $5.5 million in severance expense recognized in the first quarter of 2023.

Net loss for the first quarter of 2024 was $36.8 million or $0.19 basic and diluted loss per share as compared to a net loss of $137.0 million or $0.73 basic and diluted loss per share in the first quarter of 2023.

First Quarter 2024 and Recent Business Highlights

● In March 2024, Nektar initiated a Phase 2b study of rezpegaldesleukin in patients with severe-to-very severe alopecia areata. The Company expects topline data from this study in the first half of 2025.

● Enrollment is ongoing in the Phase 2b study of rezpegaldesleukin in patients with moderate-to-severe atopic dermatitis. The Company expects topline data from this study in the first half of 2025.

● In March 2024, we entered into a securities purchase agreement with TCG Crossover Fund, an institutional accredited investor, to sell securities in a private placement financing for gross proceeds to the Company of approximately $30 million, before deducting expenses.

Conference Call to Discuss First Quarter 2024 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time, May 9, 2024.

This press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through June 9, 2024.

To access the conference call, follow these instructions:

Dial: (800) 715-9871 (U.S & Canada)

Conference ID: 4855448