On May 4, 2023 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenomic mRNA medicines, reported financial results for the first quarter ended March 31, 2023, and highlighted recent Company progress (Press release, Omega Therapeutics, MAY 4, 2023, View Source [SID1234631041]).

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"During the first quarter we made progress across our clinical and preclinical programs in line with our broader strategic vision," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "We continue to enroll patients in the monotherapy arm of our Phase 1/2 MYCHELANGELO I study and remain on track to announce preliminary data this year. Additionally, we executed a key clinical supply agreement with Roche to evaluate the potential of our lead epigenomic controller, OTX-2002, in combination with atezolizumab, a leading anti-PD-L1 therapy, to explore the broader clinical potential of our new class of therapeutics. We expect that 2023 will be a pivotal year for Omega and we remain focused on advancing our novel approach to developing programmable epigenomic mRNA medicines in the service of patients."

Recent Corporate Highlights

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Announced a Clinical Supply Agreement with Roche: In March 2023, the Company announced a clinical supply agreement with Roche to evaluate OTX-2002 in combination with atezolizumab, an anti-PD-L1 therapy, for the treatment of c-Myc (MYC)-driven hepatocellular carcinoma (HCC) as part of Omega’s Phase 1/2 MYCHELANGELO I clinical trial. Under the terms of this agreement, Roche will supply atezolizumab and Omega will evaluate the combination as part of the overall conduct of the trial.
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Continued Enrollment into the MYCHELANGELO I Clinical Trial Evaluating OTX-2002: The Phase 1/2 study is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of OTX-2002, the Company’s

lead Omega Epigenomic Controller (OEC) designed to downregulate MYC expression pre-transcriptionally, as a monotherapy (Part 1) and in combination with standard of care therapies (Part 2) in patients with relapsed or refractory HCC and other solid tumor types known for the association with the MYC oncogene. Trial enrollment continues to progress as planned at clinical sites across the U.S. and Asia. Preliminary data from the Phase 1 monotherapy dose escalation portion of the study, including initial safety, tolerability, pharmacologic and translational data, is expected in 2023.
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Abstract Accepted for Poster Presentation at the Upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting: New preclinical data further validating Omega’s OEC platform will be shared in a poster presentation titled "Effect of MYC-targeting programmable epigenetic mRNA therapeutics on TME and immunotherapy responses" during the Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary session on June 5, 2023, from 8:00 a.m. to 11:00 a.m. CDT.
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Advanced Preclinical Evaluation of OTX-2101 for NSCLC and Other OEC Development Candidates: Investigational New Drug (IND)-enabling studies for OTX-2101, the Company’s development candidate for the treatment of MYC-driven non-small cell lung cancer (NSCLC), continue to progress. Additional preclinical work is ongoing for other OEC development programs, including a CXCL 1-8-targeting OEC with potential in multiple indications including neutrophilic asthma, acute respiratory distress syndrome (including COVID-related), oncology, and dermatological and rheumatological indications, representing a potential franchise opportunity.

First Quarter 2023 Financial Results

As of March 31, 2023, the Company had cash, cash equivalents and marketable securities totaling $136.8 million, which includes the previously disclosed approximately $39.7 million in net proceeds received from a registered direct offering of common stock in February 2023. The Company anticipates that this balance will be sufficient to fund its operations into the second half of 2024.

Research and development (R&D) expenses for the first quarter of 2023 were $20.0 million, compared to $14.2 million for the first quarter of 2022. The $5.8 million increase in R&D expenses was primarily due to increases in personnel-related expenses, clinical development costs, and external manufacturing costs and study costs to support the advancement of our programs.

General and administrative expenses (G&A) for the first quarter of 2023 were $6.0 million, compared with $5.4 million for the first quarter of 2022. The $0.6 million increase in G&A expenses was primarily due to higher personnel-related expenses to support business growth.

Net loss for the first quarter of 2023 was $25.3 million, compared with $20.2 million for the first quarter of 2022. The increase in net loss was primarily due to increases in R&D expenses to support the Company’s programs and growth.

On May 4, 2023 NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a clinical-stage biotechnology company focused on discovering and developing transformative therapeutics for patients, reported financial results for the quarterly period ended March 31, 2023 and provided business highlights (Press release, NGM Biopharmaceuticals, MAY 4, 2023, View Source [SID1234631040]).

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"We are pleased with the results of the ALPINE 4 trial supporting the therapeutic potential of aldafermin in patients with advanced NASH. We continue to make progress on our corporate strategy with the initiation of Phase 2 expansion cohorts in our proof-of-concept trial of NGM707 and the extension of our expected cash runway. With these activities, we are optimizing our resource allocation strategy towards advancing our solid tumor oncology portfolio in the clinic, while our discovery engine continues to generate new product candidates," said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM Bio. "I would like to extend my sincere gratitude and thanks to NGM Bio’s departing staff impacted by our recent restructuring for their significant contributions and unwavering commitment to discovering and developing novel, life-changing medicines for people whose health and lives are disrupted by disease."

Key First Quarter and Recent Highlights

Corporate Updates

•Announced the appointment of Dan Kaplan, Ph.D. to Chief Scientific Officer. Dr Kaplan has been a member of NGM Bio’s Research and Development organization for fourteen years, most recently as Vice President, Immuno-oncology. Jin-Long Chen, Ph.D., who founded NGM Bio and served as Chief Scientific Officer and as a member of NGM Bio’s Board of Directors, resigned from NGM Bio effective April 4, 2023.
•Announced a restructuring resulting in a reduction of NGM Bio’s workforce by 75 people, or approximately 33% of the pre-restructuring headcount. NGM Bio expects to incur approximately $5.0 million in charges in connection with the restructuring, the majority to be incurred in the second quarter. The execution of the restructuring, including cash payments, will be substantially complete by the end of the second quarter.
Solid Tumor Oncology
•Initiated the first two Phase 2b cohorts in the Phase 1/2 trial evaluating NGM707 in combination with pembrolizumab.
•Continued enrollment in the Phase 1/1b trial evaluating NGM438, a LAIR1 antagonist antibody product candidate, as a monotherapy and in combination with pembrolizumab for the treatment of patients with advanced or metastatic solid tumors.

•Continued enrollment in the Phase 1/1b trial evaluating NGM831, an ILT3 antagonist antibody product candidate, as a monotherapy and in combination with pembrolizumab for the treatment of patients with advanced or metastatic solid tumors.
Phase 2b ALPINE 4 Trial Topline Results
•Today NGM Bio is reporting topline data from the Phase 2b ALPINE 4 trial of aldafermin in 160 patients with compensated cirrhosis due to NASH (liver fibrosis stage 4, or, F4). The 48-week trial assessed the efficacy, safety and tolerability of 1 mg and 3 mg doses of aldafermin compared to placebo1.
•The study met its primary endpoint with a statistically significant reduction in ELF score from baseline to week 48 in patients treated with 3 mg of aldafermin versus patients receiving placebo. Patients receiving 3 mg of aldafermin had a 0.5 point greater reduction in ELF at week 48 compared to patients receiving placebo (p-value = 0.0003). The ELF score is a reproducible, quantitative non-invasive liver prognostic test that evaluates liver fibrosis and correlates to liver-related outcomes.
•On the secondary endpoint of fibrosis improvement of ≥1 stage (for which the trial was not statistically powered) 21% (p-value=0.39) and 23% (p-value=0.36) of patients in the 1 mg and 3 mg cohorts, respectively, achieved fibrosis improvement versus 15% in the placebo cohort.
•Aldafermin was generally well tolerated with no treatment-related serious adverse events and a safety and tolerability profile generally consistent with prior trials of aldafermin, including higher levels of gastrointestinal events in patients treated with aldafermin as compared to patients treated with placebo.

"On behalf of the entire NGM Bio team, I’d like to thank the ALPINE 4 investigators and clinical trial staff, our employees who contributed to this effort and, most importantly, the patients who participated in the study," said Hsiao D. Lieu, M.D., Chief Medical Officer at NGM Bio. "We are encouraged that we continue to see evidence of the potential therapeutic activity of aldafermin, including on the ELF biomarker that has been correlated to patient outcomes, and we look forward to having conversations with potential partners to determine further development of the program."

First Quarter 2023 Financial Results

•NGM Bio reported a net loss of $47.6 million for the quarter ended March 31, 2023, compared to a net loss of $32.5 million for the same period in 2022.
•Related party revenue from our collaboration with Merck Sharp & Dohme LLC, or Merck, was $2.2 million for the quarter ended March 31, 2023, compared to $20.9 million for the same period in 2022. Our related party revenue from Merck decreased substantially after March 2022 and is expected to continue to decrease in 2023.
•R&D expenses were $40.9 million for the quarter ended March 31, 2023, compared to $42.8 million for the same period in 2022.
•General and administrative expenses were $11.6 million for the quarter ended March 31, 2023, compared to $10.7 million for the same period in 2022.

•Cash, cash equivalents and short-term marketable securities were $231.0 million as of March 31, 2023, compared to $271.5 million as of December 31, 2022. NGM Bio expects its cash, cash equivalents and marketable securities will be sufficient to fund its planned operations into the second quarter of 2025. NGM Bio has based this estimate on plans and assumptions that may prove to be insufficient or inaccurate (for example, with respect to anticipated costs, timing or success of certain activities), and the company could utilize its available financial resources sooner than it currently expects.

On May 4, 2023 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases reported a business update and announced first quarter 2023 financial results (Press release, NextCure, MAY 4, 2023, View Source [SID1234631039]).

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"Data updates on all three of our clinical programs are expected this year," said Michael Richman, NextCure’s president and chief executive officer. "While advancing our pipeline, we have strived to remain capital efficient, and expect that we have financial runway of more than two years and the ability to achieve our meaningful near-term clinical milestones."

Q1 2023 Business Highlights and Near-Term Milestones

NC410 (LAIR-2 fusion)

● Continued enrollment in the Phase 1b/2 clinical trial evaluating NC410 in combination with pembrolizumab in patients with immune checkpoint refractory or naïve solid tumors.
● Phase 1b update is expected in the fourth quarter of 2023.

NC762 (B7-H4 mAb)

● Continued enrollment in the Phase 1b dose expansion study in patients with solid tumors and high expression of B7-H4.
● Phase 1b update is expected in the fourth quarter of 2023.

NC525 (LAIR-1 mAb)

● Dosed first patient in a Phase 1 monotherapy dose escalation and safety study evaluating NC525 in AML patients in February 2023.
● Initial Phase 1a data are expected in the fourth quarter of 2023.

Financial Guidance

● NextCure expects its existing cash, cash equivalents and marketable securities will enable it to fund operating expenses and capital expenditures into mid-2025.

Financial Results for Quarter Ended March 31, 2023

● Cash, cash equivalents, and marketable securities as of March 31, 2023, were $145.5 million as compared to $159.9 million as of December 31, 2022. The decrease of $14.4 million was primarily related to cash used to fund operations, and cash used to purchase fixed assets.
● Research and development expenses were $11.6 million for the quarter ended March 31, 2023, as compared to $15.0 million for the quarter ended March 31, 2022. The decrease of $3.4 million was primarily related to lower research and clinical costs.
● General and administrative expenses were $5.4 million for the quarter ended March 31, 2023, as compared to $5.7 million for the quarter ended March 31, 2022. The decrease of $0.3 million was primarily related to lower stock compensation costs and lower professional services costs.
● Net loss was $16.1 million for the quarter ended March 31, 2023, as compared with a net loss of $20.6 million for the quarter ended March 31, 2022. The change in net loss from the previous year was primarily due to lower research and development expenses.

On May 4, 2023 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) ("Merrimack" or the "Company") reported its first quarter 2023 financial results for the period ended March 31, 2023 (Press release, Merrimack, MAY 4, 2023, View Source [SID1234631038]).

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"During the first quarter of 2023 our operating expenses remained consistent with prior quarters and were reduced both by proceeds we received from the receipt of an option fee paid in connection with the entry into an asset purchase option agreement on a preclinical asset and increased interest income" said Gary Crocker, Chairman of Merrimack’s Board of Directors. "We continue to be focused on maintaining cash balances that will allow us to be in a position to receive potential milestone payments from Ipsen and Elevation under the programs that we previously sold to them."

First Quarter 2023 Financial Results

Merrimack reported a net loss of $271 thousand for the first quarter ended March 31, 2023, or $0.02 per basic and diluted share on a fully diluted basis, compared to a net loss of $132 thousand, or $0.01 per basic and diluted share on a fully diluted basis, for the same period in 2022.

Merrimack reported a gain on the sale of assets for the first quarter ended March 31, 2023, of $139 thousand, attributable to an asset purchase option agreement on a preclinical program, compared to $445 thousand related to an asset sale in the same period in 2022.

Interest income in the first quarter ended March 31, 2023, was $176 thousand compared to no interest income for the same period in 2022.

General and administrative expenses for the first quarter ended March 31, 2023, were $586 thousand, compared to $577 thousand for the same period in 2022.

As of March 31, 2023, Merrimack had cash and cash equivalents of $19.4 million, compared to $19.4 million as of December 31, 2022.

As of March 31, 2023, Merrimack had 14.3 million shares of common stock outstanding.

Updates on Programs Underlying Potential Milestone Payments

Ipsen

Metastatic Pancreatic Ductal Adenocarcinoma

In November 2022, Ipsen announced the Phase III NAPOLI 3 trial of Onivyde (irinotecan liposome injection) plus 5-fluorouracil/leucovorin and oxaliplatin (the "NALIRIFOX regimen") met its primary endpoint demonstrating clinically meaningful and statistically significant improvement in overall survival compared to nab-paclitaxel plus gemcitabine in 770 previously untreated patients with mPDAC and key secondary efficacy outcome of progression-free survival (PFS) also showed significant improvement over the comparator arm. Ipsen also announced that the safety profile of Onivyde in the NAPOLI 3 trial was consistent with those observed in the previous phase I/II mPDAC study.

In January 2023, Ipsen presented clinical trial results at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium.

In February 2023 Ipsen provided guidance to investors that it intends to file a supplemental New Drug Application with the U.S. Food and Drug Administration during the first half of 2023 following the Fast Track Designation granted in 2020 for the use of Onivyde in combination with oxaliplatin plus 5-fluorouracil/leucovorin for the treatment of patients with previously untreated mPDAC.

Small Cell Lung Cancer

In August 2022, Ipsen announced that the Phase III RESILIENT trial did not meet its primary endpoint of overall survival compared to topotecan. The trial is evaluating Onivyde versus topotecan in patients with small cell lung cancer, who have progressed on or after platinum-based first-line therapy treatment. In the announcement, Ipsen indicated that detailed results from the RESILIENT trial would be presented at an upcoming medical conference. The analysis concluded that the primary endpoint overall survival was not met in patients treated with Onivyde versus topotecan. However, a doubling of the secondary endpoint of objective response rate in favor of Onivyde was observed. In the August 2022 announcement, Ipsen reported that the clinical study results would be communicated with the regulatory agency. Ipsen indicated that while the results from the analysis of the RESILIENT trial have not demonstrated an overall survival benefit with Onivyde in patients in second-line small cell lung cancer, Ipsen intends to analyze the data further before decisions regarding next steps are made.

To date, there have been no further announcements by Ipsen regarding these matters and it remains unclear as to whether Ipsen will continue to seek approval for the use of Onivyde in the small cell lung cancer application. If Ipsen elects not to proceed with seeking regulatory approval, or if regulatory approval is not obtained, Merrimack would not be entitled to the $150 million milestone payment tied to FDA approval of Onivyde for treatment of small cell lung cancer.

Elevation Oncology

In January 2023, Elevation announced it is pausing further investment in the clinical development of seribantumab and intends to pursue further development only in collaboration with a partner. On March 14, 2021 Elevation Oncology announced that it would be presenting two posters on NRG1 fusions, including updated data from the Phase 2 CRESTONE study evaluating seribantumab in patients with solid tumors harboring NRG1 fusions at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, being held April 14-19, 2023. If Elevation elects not to proceed with seeking regulatory approval, or if regulatory approval is not obtained, Merrimack would not be entitled to the $54.5 million in additional potential development, regulatory approval and commercial-based milestone payments.

On May 4, 2023 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical‑stage T-cell reprogramming company advancing a diverse pipeline of cell therapies for patients with solid tumors reported financial results and business highlights for the first quarter ended March 31, 2023 (Press release, Lyell Immunopharma, MAY 4, 2023, View Source [SID1234631037]).

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"We remain focused on accumulating data in the two Phase 1 clinical trials of our wholly owned CAR T cell and TIL product candidates," said Lynn Seely, M.D., Lyell’s President and CEO. "With more than a dozen sites now open and actively screening and enrolling patients across these two trials, I am pleased with the progress we are making. We are paving the way for two initial clinical data readouts in 2024 that we expect will provide important insights on the potential of our T cell reprogramming technologies to benefit patients with solid tumors. Our strong financial position with cash runway into 2026 positions us to focus on execution, while also advancing new technologies being deployed in our pipeline of novel product candidates."

First Quarter Updates and Recent Business Highlights

Lyell is advancing four wholly-owned product candidates: two product candidates, LYL797 and LYL845, are in Phase 1 clinical development and two additional product candidates, LYL119 and a TIL product candidate incorporating novel genetic and epigenetic reprogramming technologies, are in preclinical development.

LYL797 – A ROR1 CAR T-cell product candidate genetically reprogrammed using c-Jun and epigenetically reprogrammed using Lyell’s proprietary Epi-RTM manufacturing protocol, designed for differentiated potency and durability

Enrollment in the Phase 1 clinical trial of LYL797 is ongoing at nine sites in the US. The study is enrolling patients with relapsed or refractory triple-negative breast cancer or non-small cell lung cancer. Initial clinical data from the Phase 1 trial of LYL797 are expected in the first half of 2024.
LYL845 – A novel epigenetically reprogrammed TIL product candidate designed for differentiated potency and durability

Enrollment in the Phase 1 clinical trial for LYL845 is ongoing at five sites in the US. The study is enrolling patients with relapsed and/or refractory metastatic or locally advanced melanoma, non-small cell lung cancer and colorectal cancer. Initial clinical data from the Phase 1 trial of LYL845 are expected in 2024.
LYL119 – An innovative ROR1 CAR T-cell product designed for enhanced cytotoxicity

An IND for LYL119 is expected to be submitted in the first half of 2024.
An abstract highlighting preclinical development of LYL119 has been selected for presentation at the American Society for Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 26th Annual Meeting taking place in Los Angeles, CA May 16-20, 2023.
First Quarter Financial Results

Lyell reported a net loss of $67.0 million for the first quarter ended March 31, 2023, compared to a net loss of $68.1 million for the same period in 2022. 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 certain non-cash investment gains and charges, was $44.8 million for the first quarter ended March 31, 2023, compared to $50.0 million for the same period in 2022.

Revenue

Revenue was $0.1 million for the first quarter ended March 31, 2023 compared to $0.6 million for the same period in 2022. No research and development pursuant to our collaboration and license agreement with GlaxoSmithKline (GSK Agreement) was performed in the first quarter of 2023 due to the termination of the GSK Agreement in December 2022, which drove the $0.5 million decrease in revenue.
GAAP and Non-GAAP Operating Expenses

Research and development (R&D) expenses were $44.6 million for the first quarter ended March 31, 2023, compared to $35.8 million for the same period in 2022. The increase in first quarter 2023 R&D expenses was primarily driven by non-cash expenses related to the change in the estimated fair value of success payment liabilities and an increase in personnel-related expenses, primarily related to an increase in headcount to expand our R&D and manufacturing capabilities. 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 first quarter ended March 31, 2023, were $40.6 million compared to $35.9 million for the same period in 2022. The increase in first quarter 2023 non-GAAP R&D expenses was driven by increased personnel-related expenses, primarily related to an increase in headcount to expand our clinical development and manufacturing capabilities in support of our ongoing clinical trials.
General and administrative (G&A) expenses were $19.3 million for the first quarter ended March 31, 2023, compared to $34.4 million for the same period in 2022. The decrease in first quarter 2023 G&A expenses was primarily driven by changes in non-cash stock-based compensation. Non‑GAAP G&A expenses, which exclude non-cash stock-based compensation, for the first quarter ended March 31, 2023, were $10.0 million, compared to $16.2 million for the same period in 2022. The decrease in first quarter 2023 non-GAAP G&A expenses was driven by a decrease in legal expenses.
A discussion of 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 March 31, 2023 were $668.0 million, compared to $710.3 million as of December 31, 2022. Lyell believes that its cash, cash equivalents and marketable securities balances will be sufficient to meet working capital and capital expenditure needs into 2026.