On August 4, 2022 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported its financial results for the second quarter ended June 30, 2022 and raised net sales guidance for INGREZZA in 2022 (Press release, Neurocrine Biosciences, AUG 4, 2022, View Source [SID1234617525]).

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!

"Following INGREZZA’s strong performance in the first half of this year, we raised full year net sales guidance. Growth continues to be driven by improving diagnosis and treatment rates for patients with tardive dyskinesia," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "Although disappointed that our essential tremor data was not what we hoped to see, we look forward to the continued advancement of our pipeline with the recent FDA approval to initiate a Phase 2 proof-of-concept study for the treatment of schizophrenia with our selective M4 agonist."

Second Quarter INGREZZA Net Product Sales and Commercial Highlights:

Net product sales were $350 million with total prescriptions (TRx) of approximately 64,200
Net product sales and TRx grew 32% and 31%, respectively, vs. second quarter of 2021
Sequential growth driven by record new patients and continued strength in existing patients’ refill rates
Financial Highlights:

Second quarter 2022 GAAP net loss and loss per share of $17 million and $0.18, respectively, compared with second quarter 2021 GAAP net income and diluted earnings per share of $42 million and $0.43, respectively, primarily driven by $70 million loss on extinguishment of debt in the second quarter of 2022.
Second quarter 2022 non-GAAP net income and diluted earnings per share of $82 million and $0.84, respectively, compared with $70 million and $0.72, respectively, for second quarter 2021.
Differences in second quarter 2022 GAAP and non-GAAP operating expenses compared with second quarter 2021 driven by:
Increased R&D expense in support of an expanded and advancing clinical portfolio, including $30 million milestone expense incurred for our Sosei Heptares muscarinic collaboration
Increased SG&A expense primarily due to ongoing commercial initiatives, including the INGREZZA direct-to-consumer advertising campaign which launched in May 2021 and deployment of the expanded salesforce in March 2022
Total debt outstanding decreased by $211 million to $170 million following our repurchase of approximately 55% of total debt outstanding in the second quarter of 2022. The total aggregate repurchase price of $279 million was paid in cash and resulted in the recognition of a $70 million loss on extinguishment in the second quarter of 2022.
At June 30, 2022, the Company had cash, cash equivalents and marketable securities of approximately $1.1 billion.
A reconciliation of GAAP to non-GAAP financial results can be found in Table 3 and Table 4 at the end of this earnings release.

Recent Events:

In June 2022, the Mitsubishi Tanabe Pharma Corporation (MTPC) launched DYSVAL (valbenazine) in Japan for the treatment of tardive dyskinesia. In connection with MTPC’s first commercial sale of DYSVAL in Japan, we received a milestone payment of $20.0 million, which was recognized as revenue in the second quarter of 2022.
In the second quarter of 2022, the FDA accepted our submission of an investigational new drug application (IND) for NBI-1117568 for the treatment of schizophrenia, for which we anticipate initiating a Phase 2 study during the second half of 2022. Based upon this progress, a milestone of $30.0 million was expensed as R&D in the second quarter of 2022, which we expect to pay to Sosei Heptares in the third quarter of 2022.
In August, the Phase 2a study of NBI-827104 in essential tremor did not meet specified endpoints. Based on the totality of data from the Phase 2a study, at this time, we do not plan to proceed further with the clinical development of NBI-827104 in essential tremor.

INGREZZA sales guidance for fiscal 2022 is based on recent trends and the anticipated benefit from our recently completed salesforce expansion. If new COVID-19 related disruptions emerge, the Company’s ability to meet these expectations could be negatively impacted.

GAAP R&D guidance includes (i) amounts for milestones that are probable of achievement or have been achieved and (ii) amounts for in-process research and development once significant collaboration and licensing arrangements have been completed. GAAP R&D guidance includes approximately $40 million of milestone expenses in connection with collaborations.

Non-GAAP guidance adjusted to exclude estimated non-cash stock-based compensation expense of $60 million in R&D and $110 million in SG&A.

Based upon available Federal net operating losses and tax credits, the Company expects to begin making cash payments for Federal income tax beginning in the fourth quarter of 2022.

Conference Call and Webcast Today at 4:30 PM Eastern Time
Neurocrine Biosciences will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). Participants can access the live conference call by dialing 800-895-3361 (US) or 785-424-1062 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On August 4, 2022 Cerus Corporation (Nasdaq: CERS) reported financial results for the second quarter ended June 30, 2022 (Press release, Cerus, AUG 4, 2022, View Source [SID1234617524]).

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!

Recent developments and highlights include:

Second quarter 2022 total revenue of $47.6 million, reflecting a 26% increase over the prior year period. Total revenue was composed of (in thousands, except %):

As of the date of this release, the Company is reiterating its 2022 annual product revenue guidance range of $160 million to $165 million, representing a 22% to 26% increase over full-year 2021 reported product revenue.
Second quarter 2022 net loss attributable to Cerus Corporation of $8.4 million, or $0.05 per basic and diluted share, reflecting an improvement of $7.0 million over the prior year period of $15.4 million, or $0.09 per basic and diluted share, as a result of strong product revenue growth and expense management.
Non-GAAP Adjusted EBITDA for the second quarter of 2022 was negative $2.4 million, compared to negative $8.2 million during the prior year period. For additional information, please see definitions and the reconciliation of this non-GAAP measure to net loss attributable to Cerus Corporation accompanying this release.
Cerus achieved cumulative sales for the INTERCEPT Blood System for platelets and plasma that have surpassed 12 million treatable doses globally since the products were first commercially launched.
The Company announced the appointment of Hua Shan, MD, PhD, Professor of Pathology and Medical Director, Transfusion Medicine Service at Stanford Medical Center to its Board of Directors.
Cash, cash equivalents, and short-term investments were $107.0 million at June 30, 2022.
"Our second quarter 2022 results continued our multi-year trend of strong top-line growth, once again led by sales of INTERCEPT Platelets in the United States," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "Despite the significant macroeconomic issues challenging various aspects of the global economy, our business has remained resilient as we support blood centers around the world in providing pathogen reduced blood components to patients."

"We are confident that the growth opportunities we have visibility into will be enough to offset the expected persistence of foreign exchange headwinds and therefore we are pleased today to reiterate our product revenue guidance of $160-165 million for the full year, driven by strong underlying demand for our products," Greenman continued. "Additionally, in light of our continued financial discipline, we believe the Company is well positioned and securely capitalized as we continue to make progress towards our goal of achieving cashflow breakeven."

Revenue

Product revenue during the second quarter of 2022 was $41.0 million, compared to $31.5 million during the prior year period. The year-over-year growth in product revenue during the quarter of 30% comes despite average EUR:USD rates coming down by more than 10% year-to-date. The reported revenue growth was led by continued strong demand for our platelet products in North America.

Second quarter 2022 government contract revenue was $6.6 million, compared to $6.3 million during the prior year period. Reported government contract revenue is comprised of funding associated with research and development (R&D) activities related to the INTERCEPT Blood System for Red Blood Cells and sponsored efforts related to the development of next-generation pathogen reduction technology for whole blood.

Product Gross Profit & Margin

Product gross profit for the second quarter of 2022 was $21.3 million, increasing by $5.1 million over the prior year period. Product gross margin for the second quarter of 2022 was 51.9% compared to 51.3% for the second quarter of 2021, and is roughly flat compared to the first quarter of 2022.

Operating Expenses

Total operating expenses for the second quarter of 2022 were $34.7 million compared to $36.8 million for the same period of the prior year. With a core focus on disciplined financial management to improve the overall financial profile of the business, the Company continued to demonstrate operating leverage in support of its goal of achieving cashflow breakeven in the near-term.

Selling, general and administrative (SG&A) expenses for the second quarter of 2022 totaled $19.5 million, compared to $19.8 million for the second quarter of 2021, demonstrating continued leverage of the Company’s expense structure as product sales continue to ramp.

R&D expenses for the second quarter of 2022 were $15.2 million, compared to $17.1 million for the second quarter of 2021. In the second quarter, the Company’s R&D expenses declined $1.9 million on a year-over-year basis related to the timing of new product development activities.

Net Loss Attributable to Cerus Corporation

Net loss attributable to Cerus Corporation for the second quarter of 2022 was $8.4 million, or $0.05 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $15.4 million, or $0.09 per basic and diluted share, for the second quarter of 2021.

Non-GAAP Adjusted EBITDA

Non-GAAP Adjusted EBITDA for the second quarter of 2022 was negative $2.4 million, compared to non-GAAP Adjusted EBITDA of negative $8.2 million, for the second quarter of 2021. For additional information, please see definitions and the reconciliation of this non-GAAP measure to net loss attributable to Cerus Corporation accompanying this release.

Balance Sheet & Cash Use

At June 30, 2022, the Company had cash, cash equivalents and short-term investments of $107.0 million, compared to $108.6 million at March 31, 2022.

As of June 30, 2022, the Company carried $55.0 million of notes due and a balance on its revolving line of credit of $14.9 million. The Company continues to have access to $5 million under its revolving line of credit.

For the second quarter, net cash used in operating activities totaled $0.3 million as compared to $8.7 million during the prior year period. For the first six months of 2022, net cash used in operating activities totaled $21.8 million as compared to $26.1 million during the prior year period. In both instances, increased product sales and their gross profit contribution, coupled with strong working capital management drove the improvements versus the prior year period.

Reiterating 2022 Product Revenue Guidance

The Company expects full-year 2022 product revenue will be in the range of $160-165 million, representing strong growth of approximately 22%-26% compared to full-year 2021 product revenue of $130.9 million.

Quarterly Conference Call

The Company will host a conference call at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at View Source

A replay will be available on Cerus’ website approximately three hours after the call through August 19, 2022.

On August 4, 2022 The Bayer Group reported that achieved substantial growth in the second quarter of 2022 (Press release, Bayer, AUG 4, 2022, View Source [SID1234617523]). "We delivered strong operational performance. In terms of sales, we posted significant gains at Crop Science and strong growth at Consumer Health, as well as a slight increase at Pharmaceuticals, too. And with EBITDA before special items, we even achieved growth of 30 percent," said Werner Baumann, Chairman of the Board of Management, on Thursday while presenting the company’s half-year financial report. "In view of our good business performance and higher growth expectations, we have raised our full-year guidance," he explained.

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!

Bayer does not currently see any material financial impact in 2022 from any potential gas supply bottlenecks as a result of the war in Ukraine, Baumann said. The company has taken steps to ensure that the direct impact of any potential gas shortages on its own production capabilities this year is contained to the greatest degree possible, he explained. "From a technical perspective, we are well prepared to significantly reduce our reliance on natural gas by switching to alternative and renewable sources of energy. We have also launched programs to save energy and have built up our stocks of products where possible." A higher degree of uncertainty stems from the company’s indirect exposure via its global supplier network, Baumann said. "That’s why we are expanding our network of suppliers and building up additional inventory of key raw materials and packaging materials."

In the second quarter of 2022, Group sales increased by 9.6 percent to 12.819 billion euros on a currency- and portfolio-adjusted basis (Fx & portfolio adj.). EBITDA before special items advanced by 30.0 percent to 3.349 billion euros. Positive currency effects benefited sales by 915 million euros (Q2 2021: minus 524 million euros) and EBITDA before special items by 300 million euros (Q2 2021: minus 153 million euros). EBIT came in at 169 million euros (Q2 2021: minus 2.281 billion euros) after net special charges of 2.111 billion euros (Q2 2021: 3.901 billion euros) that mainly comprised 1.322 billion euros in impairment losses on intangible assets at the Crop Science Division. These impairment losses were recognized as part of impairment testing that was performed due to a strong rise in capital market interest rates. Other special charges related to ongoing litigations and restructuring measures.

Bayer has taken an additional provision of 694 million euros in the second quarter mainly due to ongoing settlement negotiations with the State of Oregon. The settlement, when finalized, would resolve a pending environmental impairment case, involving legacy Monsanto PCB products, and result in the dismissal of the case. Given the unique challenges, trial procedures, and substantive law for this case in this Oregon venue, the company decided to pursue settlement, even though Monsanto voluntarily ceased production of PCBs in 1977 and never disposed of the chemical in this state. Bayer remains committed to defend future cases through the litigation process. Recently, a Delaware State Court dismissed all of the state’s claims in a similar PCB-related case alleging environmental impairments.

Monsanto has broad indemnity agreements with its former customers and the company will pursue its rights to recover costs associated with the PCB-related litigation. The company recently filed a complaint in the Circuit Court of St. Louis County for the State of Missouri to enforce its rights.

In the second quarter, net income amounted to minus 298 million euros (Q2 2021: minus 2.335 billion euros), while core earnings per share from continuing operations rose by 19.9 percent to 1.93 euros.

Free cash flow was level with the prior-year period, at 1.140 billion euros. Net financial debt as of June 30, 2022, came in at 36.575 billion euros, up 5.9 percent from March 31, 2022.

Significantly improved market environment at Crop Science

In the agricultural business (Crop Science), Bayer increased sales by 17.2 percent (Fx & portfolio adj.) to 6.461 billion euros, driven by a substantial improvement in the market environment. The division recorded double-digit percentage growth in Latin America and Europe/Middle East/Africa, and also registered an expansion of business in North America and Asia/Pacific. Herbicides posted the strongest growth, at 51.3 percent (Fx & portfolio adj.), with sales rising particularly in Latin and North America, as well as in Europe/Middle East/Africa as a result of prices for glyphosate-based products remaining high. Sales at Corn Seed & Traits advanced by 9.5 percent (Fx & portfolio adj.), mainly due to price increases in North America, Europe/Middle East/Africa and Latin America. In addition, volumes expanded in all regions except North America. Sales at Fungicides rose by 4.3 percent (Fx & portfolio adj.), with growth in all regions except North America, where volumes declined as a result of unfavorable weather conditions. Soybean Seed & Traits saw sales decline by 16.1 percent (Fx & portfolio adj.), largely due to the significant reduction in sales from overproduction in North America and the unit’s withdrawal from the Argentinian market.

EBITDA before special items at Crop Science climbed by 71.8 percent to 1.749 billion euros. The growth in earnings was mainly driven by the substantial improvement in business performance, as well as contributions from ongoing efficiency programs. There was also a positive currency effect of 215 million euros (Q2 2021: minus 111 million euros). By contrast, earnings were diminished by an increase in costs, particularly in the cost of goods sold, which was mainly due to high inflation. The EBITDA margin before special items rose by 6.8 percentage points to 27.1 percent.

Successful product launches at Pharmaceuticals

Sales of prescription medicines (Pharmaceuticals) increased by 2.1 percent (Fx & portfolio adj.) to 4.818 billion euros. The division’s new products, especially Nubeqa and Kerendia, continued their successful market launch, with sales of the cancer drug Nubeqa doubling compared with the prior-year quarter. However, overall sales growth was held back by additional tender procedures in China, particularly for the cancer drug Nexavar and the oral anticoagulant Xarelto, which saw their global sales fall by 29.5 percent (Fx & portfolio adj.) and 6.4 percent (Fx & portfolio adj.), respectively. Xarelto sales were also impacted by the expiration of the product’s patent in Brazil. By contrast, sales of the ophthalmology drug Eylea rose by 11.7 percent (Fx & portfolio adj.), with business up in all regions. The company was able to capture market share, particularly in Europe, thanks in part to Eylea prefilled syringes. The division also registered significant growth for Adalat, its heart disease treatment, and Aspirin Cardio, its product for secondary prevention of heart attacks. Sales of these two products were up 11.2 percent (Fx & portfolio adj.) and 18.9 percent (Fx & portfolio adj.), respectively, due to higher volumes in China. Sales of the cancer drug Stivarga increased at an even stronger rate of 27.6 percent (Fx & portfolio adj.), mainly driven by expanded volumes in China and the United States.

EBITDA before special items at Pharmaceuticals advanced by 4.9 percent to 1.478 billion euros. Higher raw material costs and increased marketing investments in new products were largely offset by the growth in sales. The division also generated income from the sale of non-core businesses. There were positive currency effects of 41 million euros (Q2 2021: minus 26 million euros). The EBITDA margin before special items amounted to 30.7 percent.

Consumer Health grows business in all regions

Bayer’s sales of self-care products (Consumer Health) advanced by 6.8 percent (Fx & portfolio adj.) to 1.496 billion euros, with broad-based growth in all regions and nearly all categories. Sales in the Allergy & Cold category rose by 16.9 percent (Fx & portfolio adj.), largely due to continuously high cold incidence rates in Europe and North America. In June, the division also started selling Astepro, a product that it switched from Rx to OTC status. As the first and only steroid-free antihistamine nasal spray available over the counter on the U.S. market, Astepro is a differentiated, fast-working solution. Sales rose by a double-digit percentage (Fx & portfolio adj.) in the Digestive Health category as well, and the Dermatology and Pain & Cardio categories also recorded significant growth. After posting substantial gains since 2020, sales in the Nutritionals category declined by 3.7 percent (Fx & portfolio adj.) but remained at a high level overall.

EBITDA before special items at Consumer Health climbed by 18.7 percent to 330 million euros. The growth in earnings was on the back of a strong rise in sales, as well as the division’s continuous cost and price management efforts in an environment of accelerating inflation. There were also positive currency effects of 49 million euros (Q2 2021: minus 20 million euros). The EBITDA margin before special items rose by 0.5 percentage points to 22.1 percent.

Outlook for 2022 raised

Following the positive development of business in the first half of 2022, Bayer remains optimistic for the remainder of the year. It has therefore raised its guidance for the Crop Science and Consumer Health divisions, and thus also for the Group as a whole.

On a currency-adjusted basis (i.e. based on the average monthly exchange rates from 2021), Bayer now expects to generate sales of 47 billion to 48 billion euros in 2022 (previously: approximately 46 billion euros). This now corresponds to an increase of about 8 percent (previously: around 5 percent) on a currency- and portfolio-adjusted basis. The company is now targeting an EBITDA margin before special items of around 26 to 27 percent (previously: around 26 percent) on a currency-adjusted basis. Based on the aforementioned sales figure, this would now correspond to EBITDA before special items of around 12.5 billion euros (previously: around 12.0 billion euros) on a currency-adjusted basis. Core earnings per share are now expected to come in at approximately 7.30 euros (previously: approximately 7.00 euros) on a currency-adjusted basis. Free cash flow is now forecast to amount to around 2.5 billion euros (previously: around 2 billion to 2.5 billion euros) on a currency-adjusted basis. In addition, the company continues to expect year-end net financial debt of approximately 33 billion to 34 billion euros on a currency-adjusted basis. As in the overall guidance, this figure does not take into account the contractually agreed divestment of the Environmental Science Professional business.

Bayer has also prepared its guidance based on the closing exchange rates as of June 30, 2022, and the differences to the currency-adjusted targets above are as follows: the company now expects to generate sales of 50 billion to 51 billion euros (previously: approximately 47 billion euros). Based on the aforementioned sales figure, Bayer is now targeting EBITDA before special items of around 13.0 billion euros (previously: around 12.0 billion euros). Core earnings per share are now expected to come in at approximately 7.70 euros (previously: approximately 7.10 euros). In addition, the company now expects year-end net financial debt of approximately 34 billion to 35 billion euros (previously: approximately 33 billion to 34 billion euros).

Sustainability: access to innovative seeds and farming solutions

Bayer also continued to make good progress in terms of sustainability. The company is supporting the Zero Hunger Pledge, which will involve helping smallholder farmers access innovative seeds, sustainable agricultural practices and farming solutions, and thus providing them with new income-generating opportunities.

Bayer has also made important progress in a major ESG rating: MSCI ESG Research recently updated their ESG Controversies Report and lifted the red flag related to "environmental concerns over GMO crops" as well as their related allegation of a breach of the UN Global Compact Principles. This marks another important milestone in improving Bayer’s ESG rating profile.

On August 4, 2022 Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision oncology products for patients with genomically defined cancers, reported financial results for the quarter ended June 30, 2022, and highlighted recent progress (Press release, Elevation Oncology, AUG 4, 2022, https://elevationoncology.com/elevation-oncology-reports-second-quarter-2022-financial-results-and-highlights-recent-company-progress/?utm_source=rss&utm_medium=rss&utm_campaign=elevation-oncology-reports-second-quarter-2022-financial-results-and-highlights-recent-company-progress [SID1234617522]).

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!

"Presenting the first-ever Phase 2 CRESTONE data for seribantumab at ASCO (Free ASCO Whitepaper) 2022, including two complete responses and two partial responses in patients whose tumors harbor NRG1 fusions, was a significant milestone for Elevation. We also completed the enrollment of the first 20 patients into Cohort 1 of CRESTONE, another milestone, and now look forward to reporting additional interim data from the ongoing study in the first half of next year," said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "Additionally, we are excited to announce the licensing of EO-3021, a differentiated antibody-drug conjugate targeting Claudin18.2 which is highly expressed especially in several types of cancers including gastrointestinal tumors. Our expanded pipeline now includes two clinical candidates for patients with solid tumors and speaks to the successful execution of our business development strategy to build an industry leading precision oncology company."

Recent Progress and Highlights

Seribatumab

Initial Phase 2 CRESTONE data presented in oral presentation at ASCO (Free ASCO Whitepaper) 2022. As of the April 18, 2022 cut-off date, findings presented at ASCO (Free ASCO Whitepaper) 2022 represent positive clinical proof-of-concept data supporting the potential of seribantumab to induce deep and durable benefit for patients with tumors harboring NRG1 fusions.
From 12 evaluable patients (per RECIST v1.1) in Cohort 1 with a median of one line of prior systemic therapy, the investigator-assessed objective response rate (INV-ORR) was 33% across all tumor types, including two complete responses (CRs; 17%) and two partial responses (PRs; 17%) In patients with non-small cell lung cancer (n=11), the INV-ORR was 36%.
Durations of response range from 1.4 – 11.5 months.
Seribantumab demonstrated a favorable and tolerable safety profile across the 35 patients with eight different tumor types evaluable for safety from Cohorts 1, 2, and 3 along with those from the safety run-in portion of the study. The majority (80%) of adverse events (AEs) were mild or moderate (Grade 1 or 2) in severity, with two Grade 3 treatment-related adverse events (TRAEs) and no Grade 4 or 5 TRAEs. No patients discontinued seribantumab due to AEs.
Seribantumab received Fast Track designation. In May 2022, Elevation Oncology announced the U.S. Food and Drug Administration’s (FDA) decision to grant Fast Track designation to seribantumab for the tumor-agnostic treatment of advanced solid tumors harboring NRG1 gene fusions. A drug candidate that receives Fast Track designation is afforded greater access to the FDA for the purpose of expediting the drug’s development, review and potential approval, and allows for eligibility for Accelerated Approval and Priority Review if relevant criteria are met.
First 20 patients enrolled into Cohort 1 of the Phase 2 CRESTONE study. Elevation Oncology achieved its enrollment milestone for the CRESTONE study in mid-2022. Patients in Cohort 1 have advanced solid tumors harboring NRG1 fusions as determined by local testing, have had no prior pan-ERBB, HER2 or HER3 targeted therapy, and are treated with seribantumab 3g QW. The Company is on track to report additional interim data from Cohort 1 including results in the first half of 2023.
EO-3021

Expanded pipeline through licensing of EO-3021. In July 2022, Elevation Oncology announced an exclusive licensing agreement with CSPC Megalith Biopharmaceutical Co., Ltd, a subsidiary of CSPC Pharmaceutical Group Limited, to develop and commercialize EO-3021 (SYSA1801), a differentiated, clinical-stage anti-Claudin18.2 antibody-drug conjugate (ADC), in all global territories outside of Greater China. The agreement includes an upfront payment of $27 million to CSPC. CSPC will also be eligible to receive up to $148 million in potential development and regulatory milestones and up to $1.0 billion in potential commercial milestones, plus royalties on net sales. Elevation Oncology expects to initiate a Phase 1 clinical trial in the US to evaluate EO-3021 in solid tumors in 2023.
Claudin18.2 is a clinically validated oncology target expressed in several solid tumor types.
EO-3021 (SYSA1801) is an ADC that binds to Claudin18.2 and delivers a cytotoxic payload to eliminate tumor cells. ADCs are a proven therapeutic modality in the clinical setting, and the FDA has approved multiple ADCs in recent years to treat various cancers.
Corporate

Secured $50 million loan facility. In July 2022, Elevation Oncology secured a $50 million loan facility from K2 HealthVentures, a leading healthcare-focused investment firm. An initial tranche of $30 million was made available immediately, with a second tranche consisting of up to $20 million to be available in the future, subject to both parties’ mutual agreement. The initial proceeds from the facility were used primarily to fund an upfront payment of $27 million for the licensing of EO-3021 (SYSA1801) from CSPC Pharmaceutical Group.
Expected Upcoming Milestones and Operational Objectives

Additional interim seribantumab data from the Phase 2 CRESTONE study are expected in the first half of 2023
Phase 1 clinical trial in the US to evaluate EO-3021 expected to initiate in 2023
Topline data for seribantumab from the Phase 2 CRESTONE study results are expected in 2024
Ongoing target evaluation and continued execution of the Company’s strategy for future pipeline expansion
Second Quarter 2022 Financial Results

As of June 30, 2022, the Company had cash, cash equivalents and marketable securities totaling $122.5 million, compared to $132.1 million as of March 31, 2022.

Research and development expenses for the second quarter 2022 were $16.3 million, compared to $3.9 million for the second quarter 2021. The increase in R&D expense was primarily related to an increase in manufacturing, personnel costs and other expenses associated with the Phase 2 CRESTONE study.

General and administrative expenses for the second quarter 2022 were $3.8 million, compared to $1.1 million for the second quarter 2021. The increase in G&A expense was primarily related to personnel costs, professional services and other administrative costs.

Net loss for the second quarter 2022 was $19.9 million, compared to $5.1 million for the second quarter 2021.

Financial Outlook

Elevation Oncology expects its cash, cash equivalents and marketable securities as of June 30, 2022, and following the licensing of EO-3021 and the initial tranche of the loan facility, to fund current operations, including the continued development of seribantumab and EO-3021, into 2024.

On August 4, 2022 Sanofi and Innovent Biologics (HKEX: 1801.HK, "Innovent") reported a collaboration to bring innovative medicines to patients in China with difficult-to-treat cancers. Innovent is a leading biopharmaceutical company with strong clinical development capabilities and a broad commercial footprint in China (Press release, Sanofi, AUG 4, 2022, View Source [SID1234617521]). Both companies are committed to accelerating the development and commercialization of two Sanofi key clinical stage oncology assets: Phase III SAR408701 (tusamitamab ravtansine; anti-CEACAM5 antibody-drug conjugate) and Phase II SAR444245 (non-alpha IL-2), combining with sintilimab, the leading checkpoint inhibitor in China.

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!

In addition to the collaboration and license agreement, Sanofi will invest €300 million in Innovent through subscription of new common shares.

John Reed, M.D., Ph.D.
Global Head of Research and Development at Sanofi

"This strategic collaboration with Innovent will not only accelerate the development, market access and future commercialization of two of our key oncology medicines in selected combinations with sintilimab, but also bolster our overall presence in oncology in China. We look forward to a successful partnership with Innovent, one of the most innovative companies in China, and to leveraging their development capabilities and market leadership in the country."

Michael Yu, Ph.D.
Founder, Chairman and CEO of Innovent

"This strategic collaboration with Sanofi, a leading global pharmaceutical company, opens the pathway to great synergy for accelerating the pace of innovation. This pioneering partnership will leverage the synergy between Sanofi and Innovent’s pipeline and R&D resources with the mutual aim to address major unmet medical needs for cancer patients. We hope this agreement will be a great start of the two parties’ long-term partnership, and we look forward to bringing more innovative therapies to patients."

Clinical development and commercialization of tusamitamab ravtansine

SAR408701 (tusamitamab ravtansine) is a potential first-in-class antibody-drug conjugate (ADC) targeting CEACAM5 (carcinoembryonic antigen-related cell adhesion molecule 5), a cell-surface glycoprotein that is highly expressed in non-small cell lung cancer (NSCLC), gastric cancer and other cancers. SAR408701 is currently in a Phase 3 study for 2L NSCLC globally including China, and global Phase 2 studies in additional indications including 1L NSCLC, gastric cancers and other solid tumors.

According to the agreement, Innovent will be responsible for developing and exclusively commercializing tusamitamab in multiple oncology-based indications in China. Sanofi will be entitled to receive up to €80 million development milestone payment and royalties on the net sales of the product in China upon approval.

Clinical development and commercialization of SAR444245

SAR444245 is a potential first-in-class reprogrammed, site-directed, single PEGylated, recombinant human IL-2 (rIL-2) variant with extended half-life that specifically binds to the low-affinity IL-2 receptor but lacks binding affinity for the αlpha chain of the high-affinity IL-2 receptor. SAR444245(IL-2) is currently under global Phase 2 studies for skin cancers, gastrointestinal cancer, NSCLC / mesothelioma, head and neck tumors, and lymphoma.

Innovent and Sanofi will jointly explore the development of SAR444245 in China in various cancer types, where Innovent will lead the clinical development. Sanofi remains the sole Marketing Authorization holder for both assets and will be fully responsible for SAR245 commercialization. Innovent will be entitled to receive up to €60 million development milestone payments and royalties on the net sales of the product in China upon approval.

Sanofi’s initial strategic equity investment in Innovent for €300 million

In addition to the strategic multi-product collaboration and license agreement, Sanofi, subject to conditions precedent including regulatory approval and customary closing conditions, will invest in new common shares issued by Innovent for €300 million, at a price of HK $42.42 per share, representing a 20% premium to the Innovent 30-trading-day average share price as of August 3, 2022, one day prior to the signing of the agreements.

Subject to mutual agreement of both parties in the future, Sanofi will have the right to acquire additional Innovent new common shares for €300 million, at a subscription price that represents 20% premium to Innovent 30-trading-day average share price as the date of the separate agreement that may be entered into by both parties.

About SAR408701

SAR408701 (tusamitamab ravtansine) is a potential first-in-class antibody-drug conjugate (ADC) targeting CEACAM5 (carcinoembryonic antigen-related cell adhesion molecule 5), a cell-surface glycoprotein that is highly expressed in non-small cell lung cancer (NSCLC), gastric cancer and other cancers. Tusamitamab ravtansine is currently in a Phase 3 study for second-line NSCLC globally including China, and global Phase 2 studies in additional indications including first-line NSCLC, gastric cancers and other solid tumors.

About SAR444245
SAR444245 is a potential first-in-class recombinant human IL-2 (rIL-2) variant that includes a site-directed single PEG moiety/chain that prevents it from binding to the α chain of the IL-2 receptor while retaining near-native affinity for the beta/gamma subunits.

SAR444245 is currently being investigated in global Phase 2 studies for the treatment of skin cancers, gastrointestinal cancer, NSCLC / mesothelioma, head and neck tumors, and lymphoma.

About Sintilimab (TYVYT)
Sintilimab, marketed as TYVYT (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody jointly developed by Innovent and Eli Lilly and Company. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. In China, sintilimab has been approved for six indications including relapsed or refractory classic Hodgkin’s lymphoma, first-line treatment of non-squamous NSCLC, first-line treatment of squamous NSCLC, first-line treatment of hepatocellular carcinoma, first-line treatment of esophageal squamous cell carcinoma, and first-line treatment of gastric or gastroesophageal junction adenocarcinoma, of which the first four indications have been included in the National Reimbursement Drug List (NRDL).

Note:
SAR408701 and SAR444245 are not approved products in China