On August 4, 2022 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported its financial results for the second quarter ended June 30, 2022, and provided a business update (Press release, Nuvation Bio, AUG 4, 2022, View Source [SID1234617613]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are committed to advancing innovative therapies as quickly and safely as possible for people with cancers that do not currently have adequate treatment options. As previously announced, this commitment has led us to re-prioritize our pipeline and focus on our BET inhibitor, NUV-868, which is progressing in an ongoing Phase 1 study, and our novel small molecule DDC platform," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "With $703.8 million in cash, cash equivalents and marketable securities as of June 30, 2022, and our experienced team — including our new Chief Medical Officer, David Liu, M.D., Ph.D., and our new Chief Regulatory Officer, Kerry Wentworth — we are well positioned to advance our programs for the benefit of patients and our stakeholders."

Recent Business Updates

NUV-868, BD2-Selective BETi: Advanced solid tumors

Dosing underway in the Phase 1 monotherapy study of NUV-868. The recently initiated Phase 1 study in advanced solid tumors, including ovarian, pancreatic, metastatic castration-resistant prostate and triple negative breast cancers, is designed to determine the safety and dose of NUV-868 to be used as a monotherapy and in combination with olaparib or enzalutamide for the Phase 2 and Phase 2b portions of the study.
Corporate Updates

Strengthened executive management team. The Company appointed David Liu, M.D., Ph.D., as Chief Medical Officer in July 2022, and Kerry Wentworth as Chief Regulatory Officer in May 2022. Both leaders are also part of the Executive Committee.
Second Quarter 2022 Financial Results

As of June 30, 2022, Nuvation Bio had cash, cash equivalents and marketable securities of $703.8 million.

For the three months ended June 30, 2022, research and development expenses were $28.9 million, compared to $14.0 million for the three months ended June 30, 2021. The increase was primarily due to a $12.3 million increase in third-party costs related to research services and manufacturing to advance our current preclinical programs and Phase 1/2 clinical trial, as well as a $2.5 million increase in personnel-related costs driven by an increase in headcount and stock-based compensation.

For the three months ended June 30, 2022, general and administrative expenses were $8.9 million, compared to $6.4 million for the three months ended June 30, 2021. The increase was primarily due to a $1.9 million increase in personnel-related costs driven by an increase in headcount and stock-based compensation, a $0.4 million increase in other miscellaneous expenses, a $0.1 million increase in legal fees, a $0.1 million increase in taxes, a $0.1 million increase in occupancy expenses, and a $0.1 million increase in insurance, offset by a $0.2 million decrease in professional fees.

For the three months ended June 30, 2022, Nuvation Bio reported a net loss of $34.9 million, or $0.16 per share. This compares to a net loss of $19.3 million, or $0.09 per share, for the comparable period in 2021.

On August 1, 2022, Nuvation Bio announced a restructuring, including a 35% workforce reduction, to reduce operating costs and align its organization with its re-prioritized development programs.

On August 4, 2022 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that financial results for the second quarter ended June 30, 2022 (Press release, Puma Biotechnology, AUG 4, 2022, View Source [SID1234617612]). Unless otherwise stated, all comparisons are for the second quarter of 2022 compared to the second quarter of 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Product revenue, net consists entirely of sales revenue from NERLYNX, Puma’s first commercial product. Product revenue, net in the second quarter of 2022 was $51.3 million, compared to $48.9 million in the second quarter of 2021. Product revenue, net in the first six months of 2022 was $92.0 million, compared to $94.7 million in the first six months of 2021.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $9.4 million, or $0.21 per basic and diluted share, for the second quarter of 2022, compared to a net loss of $5.1 million, or $0.13 per share, for the second quarter of 2021. Net income for the first six months of 2022 was $6.0 million, or $0.14 per basic and diluted share, compared to net income of $11.3 million, or $0.28 per basic and diluted share, for the first six months of 2021.

Non-GAAP adjusted net income was $12.6 million, or $0.28 per basic and diluted share, for the second quarter of 2022, compared to non-GAAP adjusted net income of $13.1 million, or $0.32 per basic and diluted share, for the second quarter of 2021. Non-GAAP adjusted net income for the first six months of 2022 was $12.4 million, or $0.28 per basic and diluted share, compared to non-GAAP adjusted net income of $35.4 million, or $0.88 per basic share and $0.87 per diluted share, for the first six months of 2021. Non-GAAP adjusted net income excludes stock-based compensation expense. For a reconciliation of GAAP net income (loss) to non-GAAP adjusted net income and GAAP net income (loss) per share to non-GAAP adjusted net income per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the second quarter of 2022 was $13.9 million, compared to net cash used in operating activities of $0.1 million in the second quarter of 2021. Net cash used in operating activities for the first six months of 2022 was $40.8 million, compared to net cash provided by operating activities of $15.6 million in the first six months of 2021. At June 30, 2022, Puma had cash, cash equivalents and marketable securities of $60.8 million, compared to cash, cash equivalents and marketable securities of $82.1 million at December 31, 2021.

"We are very pleased to report positive net income and earnings per share for the second quarter of 2022," said Alan H. Auerbach, Chairman, Chief Executive Officer, and President of Puma. "This is being driven by the worldwide commercial revenues and royalties from NERLYNX, coupled with our ongoing efforts to reduce operating expenses. Our commercial execution strategy is designed to support increased patient access to NERLYNX, and we are pleased to continue to move forward with our goal of improving the lives of patients battling cancer.

"As per our earlier guidance, in June we reported top line data from the randomized cohort of the Phase II SUMMIT trial of neratinib in hormone receptor positive breast cancer that has a HER2 mutation, as well as final results from the biliary tract cohort of the Phase II SUMMIT ‘basket’ trial at the 2022 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), enabling us to move forward in our goal of demonstrating the effect of NERLYNX across various types of cancer."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) reporting Phase II data from the cohort of patients in the SUMMIT basket trial of neratinib in non-small cell lung cancer patients with EGFR exon 18 mutations (H2 2022); (ii) conducting a meeting with the FDA to discuss the registration pathway of neratinib in HER2-mutated HR-positive breast cancer (H2 2022); (iii) conducting a meeting with the FDA to discuss the registration pathway for neratinib in non-small cell lung cancer patients with EGFR exon 18 mutations who have previously been treated with an EGFR tyrosine kinase inhibitor (2022); (iv) reporting Phase II TBCRC-022 trial data from Cohort 4B and 4C of the combination of Kadcyla plus neratinib in patients with HER2-positive breast cancer with brain metastases who have previously been treated with Kadcyla (H2 2022); and (v) reporting Phase II data from the SUMMIT trial of neratinib in cervical cancer patients with HER2 mutations (H2 2022)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, license revenue from Puma’s sub-licensees and royalty revenue. For the second quarter of 2022, total revenue was $59.5 million, of which $51.3 million was net product revenue and $8.2 million was royalty revenue. This compares to total revenue of $53.4 million in the second quarter of 2021, of which $48.9 million was net product revenue, $0.2 million was license revenue received from Puma’s sub-licensees, and $4.3 million was royalty revenue. For the first six months of 2022, total revenue was $105.3 million, of which $92.0 million was net product revenue and $13.3 million was royalty revenue. This compares to total revenue for the first six months of 2021 of $151.6 million, of which $94.7 million was net product revenue, $50.3 million was license revenue received from Puma’s sub-licensees, which included a $50 million upfront payment for providing development, manufacturing, and commercial rights to NERLYNX in Greater China to Pierre Fabre, and $6.6 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $47.4 million for the second quarter of 2022, compared to $70.0 million for the second quarter of 2021. Operating costs and expenses in the first six months of 2022 were $94.0 million, compared to $148.1 million in the first six months of 2021.

Cost of Sales

Cost of sales was $14.9 million for the second quarter of 2022, compared to $12.0 million for the second quarter of 2021. Cost of sales was $25.8 million for the first six months of 2022, compared to $41.5 million for the first six months of 2021, of which $20.0 million was for a termination fee paid to a former sub-licensee for the return of commercial rights to NERLYNX in Greater China.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $20.6 million for the second quarter of 2022, compared to $39.4 million for the second quarter of 2021. SG&A expenses for the first six months of 2022 were $41.0 million, compared to $67.7 million for the first six months of 2021. The $26.7 million year-over-year decrease for the first six months resulted primarily from a decrease in payroll and related costs of approximately $7.2 million, consisting of approximately $5.2 million from lower headcount and a $2.0 million payroll tax credit under the CARES Act; a $4.0 million decrease in consultants fees related to marketing and commercialization support; and a decrease in stock-based compensation expense of approximately $16.0 million, primarily due to the $13.6 million incremental expense resulting from the modification to the term of Mr. Auerbach’s warrant in 2021, and approximately $2.4 million due to lower headcount.

Research and Development Expenses

Research and development (R&D) expenses were $11.9 million for the second quarter of 2022, compared to $18.6 million for the second quarter of 2021. R&D expenses for the first six months of 2022 were $27.2 million, compared to $38.9 million for the first six months of 2021. The $11.7 million year-over-year decrease for the first six months resulted primarily from a decrease in clinical trial expense of $2.8 million; a decrease in internal R&D expense of $5.3 million, which reflects a $3.6 million decrease from reduced headcount and clinical trial activity and a decrease of $1.8 million for a payroll tax credit under the CARES Act; a decrease in consultant and contractors’ expense of $1.8 million, primarily due to the close of the CONTROL study and a reduction in the number of patients being treated in the SUMMIT study; and a decrease in stock-based compensation expense of $1.7 million, primarily due to the impact of headcount reductions in 2021.

Total Other Income (Expenses)

Total other expenses were $2.6 million for the second quarter of 2022, compared to total other income of $11.5 million for the second quarter of 2021. Total other expenses were $5.2 million for the first six months of 2022, compared to total other income of $7.9 million for the first six months of 2021. The $13.1 million year-over-year increase in other expenses for the first six months of 2022 resulted primarily from the recognition of $14.9 million in legal verdict contra-expense in the first six months of 2021, which represented an adjustment to the amount originally recorded for the Eshelman v. Puma Biotechnology, Inc., et al. judgment due to a subsequent ruling on the matter, partially offset by an estimate of service fees incurred related to the class action administrator and pre-judgment interest as a result of the Hsu v. Puma Biotechnology, Inc., et al. claims process.

Conference Call

Puma Biotechnology will host a conference call to report its second quarter 2022 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, August 4, 2022. The call may be accessed by dialing (877) 709-8150 (domestic) or (201) 689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.

On August 4, 2022 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported financial results for the second quarter ended June 30, 2022 (Press release, Repare Therapeutics, AUG 4, 2022, View Source [SID1234617611]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The worldwide license and collaboration agreement we signed with Roche this quarter represents a major step in the broad global development and commercialization of camonsertib, and validates our strategy to build value into our pipeline by developing innovative drugs that target specific synthetic-lethal genomic alterations as we recently demonstrated at AACR (Free AACR Whitepaper)," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "We have made substantial progress in our Phase 1 clinical trial evaluating RP-6306 as a monotherapy and in combination with camonsertib and two chemotherapy agents for the treatment of molecularly selected advanced solid tumors. We have also advanced our polymerase theta inhibitor, RP-2119, to IND-enabling studies. We look forward to providing an initial clinical data readout from the Phase 1 RP-6306 trial in the first half of 2023."

Second Quarter 2022 Review and Operational Updates:

Announced closing of its worldwide license and collaboration agreement with Roche for the development and commercialization of camonsertib (also known as RP-3500), a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase) for the treatment of tumors with specific synthetic-lethal genomic alterations.
In connection with the closing of the collaboration agreement, Repare received an upfront payment of $125 million from Roche in July 2022.
Under the collaboration, Roche will assume the development of camonsertib with the potential to expand development into additional tumor indications and multiple combination studies.
In addition to the $125 million upfront payment, Repare is eligible to receive up to $1.172 billion in potential clinical, regulatory, commercial and sales milestones, including up to $55 million in potential near-term payments, and royalties on global net sales ranging from high-single-digits to high-teens. The collaboration also provides Repare with the ability to opt-in to a 50/50 U.S. co-development and profit share arrangement, including participation in U.S. co-promotion if U.S. regulatory approval is received. If Repare chooses to exercise its co-development and profit share option, it will continue to be eligible to receive certain clinical, regulatory, commercial and sales milestone payments, in addition to full ex-U.S. royalties.
Advanced RP-6306, a first-in-class, oral PKMYT1 inhibitor as a monotherapy and in combinations
Phase 1 clinical trials are currently evaluating RP-6306 as a monotherapy (MYTHIC) as well as in combination with gemcitabine (MAGNETIC) for the treatment of molecularly selected advanced solid tumors. In January 2022, the Company initiated an additional Phase 1 clinical trial of RP-6306 in combination with FOLFIRI (MINOTAUR), also for the treatment of molecularly selected advanced solid tumors.
In May 2022, Repare initiated patient recruitment in a new arm of the Phase 1 MYTHIC clinical trial, which is designed to evaluate the safety and tolerability of RP-6306 in combination with camonsertib in patients with advanced solid tumors.
Initial Phase 1 clinical data readout for RP-6306 is now expected in the first half of 2023 for monotherapy (previously expected in the second half 2022) and potentially for combination therapies, due to disruptions in global trial site activation and enrollment resulting from the ongoing COVID-19 pandemic, as well as an expanded requirement for dose escalations that are ongoing.
Initiated IND-enabling studies for Repare’s Polθ inhibitor (now designated RP-2119), and plan to initiate clinical trials in the summer of 2023.
Repare also expects to initiate IND-enabling studies in the first half of 2023 for an additional small molecule against an undisclosed target.
Second Quarter 2022 Financial Results:

Cash and cash equivalents and marketable securities: Cash and cash equivalents and marketable securities as of June 30, 2022 were $282.1 million, which excludes the $125 million now received from Roche and extends cash runway into 2026.
Revenue: Repare recognized revenue of $0.7 million and $1.1 million for the three and six-month periods ended June 30, 2022, respectively, in connection with the Bristol Myers Squibb agreement and research activities performed.
Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $31.5 million and $57.9 million for the three- and six-month periods ended June 30, 2022, respectively, as compared to $20.2 million and $36.7 million for the three- and six-month periods ended June 30, 2021. The increase in R&D expenses for the three- and six-month periods were primarily due to an increase in direct external costs, primarily for development activities as a result of increased efforts towards advancing the development of the RP-3500 and RP-6306 programs; personnel-related costs, primarily related to increased headcount in support of discovery and development activities; and other research and development costs.
General and administrative (G&A) expenses: G&A expenses were $7.9 million and $16.7 million for the three- and six-month periods ended June 30, 2022, respectively, as compared to $6.7 million and $12.0 million for the three- and six-month periods ended June 30, 2021. The increase in G&A expenses for the three- and six-month periods were primarily due to increases in personnel related costs including share-based compensation; professional costs; and other general and administrative costs.
Net loss: Net loss was $38.1 million, or $0.91 per share, and $72.9 million, or $1.74 per share, in the three- and six-month periods ended June 30, 2022, respectively, and $26.3 million, or $0.71 per share and $47.7 million, or $1.29 per share, in the three-month and six-month periods ended June 30, 2021, respectively.
About Repare Therapeutics’ SNIPRx Platform

Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.

On August 4, 2022 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported second quarter 2022 financial results and recent portfolio updates (Press release, SQZ Biotech, AUG 4, 2022, View Source [SID1234617609]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited by meaningful progress in our clinical trials and also the receipt of FDA Fast Track Designation for our APC clinical candidate across HPV16+ tumors," said Armon Sharei, Ph.D., CEO and Founder at SQZ Biotechnologies. "We also highlighted the progress in developing our Point-of-Care manufacturing system which supports our long-term vision to enable broad accessibility of cell therapies. Finally, I am delighted by the addition of our newest senior team member, Dr. Marshelle Smith Warren as our Chief Medical Officer, and the elevation of Micah Zajic to Chief Financial Officer."

Second Quarter 2022 and Recent Portfolio Updates

SQZ Antigen Presenting Cell ("APC") Platform in Oncology

Granted FDA Fast Track Designation for SQZ-PBMC-HPV, our APC clinical candidate, for HPV16+ advanced or metastatic tumors
Continued enrollment of high dose monotherapy and combination with checkpoint inhibitors in the Phase 1/2 (SQZ-PBMC-HPV) trial
SQZ Enhanced Antigen Presenting Cell ("eAPC") Platform in Oncology

Presented SQZ eAPC preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting demonstrating that delivery of multiple mRNAs encoding for disease-specific antigens and immune stimulators had a synergistic effect that substantially increased killer T cell activity in humanized mouse models
Initiated enrollment and opened additional sites for the monotherapy stage of the COMMANDER-001 Phase 1/2 (SQZ-eAPC-HPV) trial
SQZ Activating Antigen Carriers ("AAC") Platform in Oncology

Published trial in progress poster at the AACR (Free AACR Whitepaper) annual meeting highlighting the SQZ AAC platforms potential to drive robust CD8 T cell activation and tumor killing
Continued enrollment and opened additional sites for the monotherapy stage of the ENVOY-001 Phase 1/2 (SQZ-AAC-HPV-101) trial
SQZ Tolerizing Antigen Carriers ("TAC") Platform in Immune Tolerance

Published comprehensive preclinical research in Frontiers in Immunology
Progressed studies supporting anticipated TAC IND submission for celiac disease in the first half of 2023; company’s POC manufacturing system intended to produce clinical batches
SQZ Point-of-Care Manufacturing

Presented non-clinical POC manufacturing performance data at the American Society for Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) annual meeting demonstrating reduced manufacturing time and comparable or improved product specifications relative to current cleanroom-based processes
Recent Corporate Highlights

Appointed two experienced executives to leadership roles: Marshelle Smith Warren, M.D. joined as Chief Medical Officer, and Micah Zajic was elevated to Chief Financial Officer
Second Quarter 2022 Financial Highlights

Revenue for the quarter ended June 30, 2022, was $3.2 million compared to $4.5 million for the same period in 2021
Research and development expenses for the quarter ended June 30, 2022, were $18.8 million compared to $17.7 million for the same period in 2021; the increase was primarily due to higher personnel-related costs including stock-based compensation expense, to support continued progress with the company’s pipeline
General and administrative expenses for the quarter ended June 30, 2022, were $7.0 million compared to $5.9 million for the same period in 2021; the increase was primarily due to higher personnel and other corporate-related costs, including stock-based compensation expense and other costs
Net loss for the quarter ended June 30, 2022, was $22.2 million, compared to $19.1 million for the same period in 2021
As of June 30, 2022, the Company had cash and cash equivalents of $105.6 million and anticipates this will be sufficient to fund operating expenses and capital expenditure requirements into the fourth quarter of 2023

On August 4, 2022 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [("Merrimack" or the "Company")] reported its second quarter 2022 financial results for the period ended June 30, 2022 (Press release, Merrimack, AUG 4, 2022, View Source [SID1234617608]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased to report continued reductions in operating expenses as we remain focused on conserving cash to ensure that we have sufficient financial resources to capture future potential milestone payments from Ipsen Pharmacology and Elevation Oncology" said Gary Crocker, Chairman of Merrimack’s Board of Directors. "We will continue to monitor developments in Ipsen’s Onivyde (irinotecan liposomal injection) program and Elevation’s seribantumab program."

Second Quarter 2022 Financial Results

Merrimack reported a net loss of $478 thousand for the second quarter ended June 30, 2022, or $0.04 per basic and diluted share on a fully diluted basis, compared to a net loss of $759 thousand, or $0.06 per basic and diluted share on a fully diluted basis, for the same period in 2021.

General and administrative expenses for the second quarter ended June 30, 2022, were $486 thousand, compared to $778 thousand for the same period in 2021.

As of June 30, 2022, Merrimack had cash and cash equivalents of $13.4 million, compared to $14.2 million as of December 31, 2021.

As of June 30, 2022, Merrimack had 13.4 million shares of common stock outstanding.

Updates on Programs Underlying Potential Milestone Payments

Ipsen

– On August 3, 2022, Ipsen announced results from its Phase III RESILIENT trial evaluating Onivyde in second-line monotherapy for small cell lung cancer. The announcement indicated that "the primary endpoint OS was not met in patients treated with Onivyde versus topotecan. However, a doubling of the secondary endpoint of objective response rate (ORR) in favor of Onivyde was observed. The safety and tolerability of Onivyde was consistent with its already-known safety profile, and no new safety concerns emerged. The clinical study results will be communicated with the regulatory agency." Ipsen indicated in its update that it will analyze the data further before making decisions about next steps.

– On July 28, 2022, Ipsen provided a public update on its sales performance for the first half of 2022 and indicated that top line data from its continuing Phase 3 study of ONIVYDE in first line pancreatic ductal adenocarcinoma were anticipated to be available during the second half of 2022.

Elevation Oncology

– On May 26, 2022, Elevation Oncology released to the public initial proof-of-concept data from its phase 2 CRESTONE Study evaluating the HER3 monoclonal antibody seribantumab in patients with tumors harboring NRG1 fusions at ASCO (Free ASCO Whitepaper) 2022. The most recent corporate presentation from Elevation indicates that top line data from this trial are expected in 2024.