On February 7, 2024 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, reported that James Caruso, president and chief executive officer of Cellectar, will present an overview of the company at the upcoming Oppenheimer 34th Annual Healthcare Life Sciences Conference being held virtually (Press release, Cellectar Biosciences, FEB 7, 2024, View Source [SID1234639907]). Details of the presentation are as follows:

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Date: Wednesday, February 14, 2024
Time: 2:00 – 2:30 pm Eastern Time
Webcast: Click HERE

A replay of the presentation will be available on Events section of the company’s investor relations website.

On February 7, 2024 Bristol Myers Squibb (NYSE: BMY) reported two regulatory acceptances for applications for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC) (Press release, Bristol-Myers Squibb, FEB 7, 2024, View Source [SID1234639906]). The U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics Application (sBLA) and assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 8, 2024. In late January, the European Medicines Agency (EMA) validated the type II variation application which confirms the submission is complete and begins the start of the EMA’s centralized review process.

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"Between 30% to 55% of non-small cell lung cancer patients who undergo surgery will experience disease recurrence. We are working to expand options that improve outcomes for patients with resectable disease, as part of our comprehensive approach to the treatment of multiple types of cancer, including and especially in earlier stages," said Abderrahim Oukessou, M.D., vice president, thoracic cancers global program lead, Bristol Myers Squibb. "With CheckMate -77T, we have evaluated the potential for neoadjuvant immunotherapy to induce pathological complete response and the role of perioperative Opdivo treatment in reducing the likelihood that the cancer will return and help make extended survival possible for patients. The acceptance of these applicationsunderscores our impactful progress in addressing unmet needs across several non-small cell lung cancer treatment settings and brings us one step closer to offering a new perioperative Opdivo-based regimen to patients who may benefit."

The submissions were based on results from the Phase 3 CheckMate -77T trial, which represents the company’s second positive Phase 3 randomized trial with an immunotherapy-based combination for the treatment of resectable NSCLC, showing statistically significant and clinically meaningful improvements in event-free survival (EFS), the study’s primary endpoint. The study also showed benefits in key secondary endpoints including pathologic complete response (pCR) and major pathologic response (MPR). Additionally, the perioperative regimen had a safety profile consistent with previously reported studies in NSCLC and no new safety signals were identified. The EFS, pCR and MPR results from CheckMate -77T were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023. The study remains ongoing to assess another secondary endpoint of overall survival (OS).

Opdivo and Opdivo-based combinations have shown efficacy benefits in the neoadjuvant, adjuvant or perioperative settings across four cancers to date, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.

About CheckMate -77T
CheckMate -77T is a Phase 3 randomized, double-blind, placebo-controlled, multi-center trial evaluating neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo versus neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo in 452 patients with resectable stage IIA to IIIB non-small cell lung cancer (NSCLC). The primary endpoint of the trial is event-free survival (EFS). Secondary endpoints include overall survival (OS), pathologic complete response (pCR) and major pathologic response (MPR).

About Lung Cancer
Lung cancer is the leading cause of cancer deaths globally. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer, representing up to 84% of diagnoses. Non-metastatic cases account for the majority of NSCLC diagnoses (approximately 60%, with up to half of these being resectable), and the proportion is expected to grow over time with enhanced screening programs. While many non-metastatic NSCLC patients are cured by surgery, 30% to 55% develop recurrence and die of their disease despite resection, contributing to a need for treatment options administered before surgery (neoadjuvant) and/or after surgery (adjuvant) to improve long-term outcomes.

On February 7, 2024 Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that management will participate in a fireside chat at the Oppenheimer 34th Annual Healthcare Life Sciences Conference on February 14, 2024, at 10 a.m. ET (Press release, Bicycle Therapeutics, FEB 7, 2024, View Source [SID1234639905]).

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A live webcast of the fireside chat will be accessible from the Investor section of the company’s website, www.bicycletherapeutics.com. A replay of the webcast will be archived and available following the event.

On February 7, 2024 Ascendis Pharma A/S (Nasdaq: ASND) reported financial results for the fourth quarter and full year ended December 31, 2023 and provided a business update (Press release, Ascendis Pharma, FEB 7, 2024, View Source [SID1234639904]).

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"In 2023, we streamlined Ascendis, including our structure, processes, and operating expense allocation, and at the same time we believe we remain on track to achieve Vision 3×3," said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. "SKYTROFA is the leading growth hormone product in value in the U.S., the launch of YORVIPATH in our Europe Direct and International Markets segments is underway beginning with Germany and Austria, and our clinical program for TransCon CNP is advancing. Ascendis is a leaner, more efficient organization in 2024, well-positioned to fulfill the strategic goals outlined in our Vision 2030, including achieving blockbuster status for each of our three independent Endocrinology Rare Disease products and expanding our engine for future innovation."

Select 2023 Highlights & Anticipated 2024 Milestones

TransCon hGH:
(lonapegsomatropin, approved as SKYTROFA in the U.S. and EU)
Fourth quarter SKYTROFA revenue totaled €64 million, a 37% sequential increase. Full year 2023 SKYTROFA revenue totaled €179 million compared to €36 million the year prior.
Q4-2022 Q1-2023 Q2-2023 Q3-2023 Q4-2023
SKYTROFA revenue (millions) €17 €32 €36 €47 €64

Full year 2024 SKYTROFA revenue expected to be €320 million to €340 million (based on average 2023 exchange rates).
Plan to submit a supplemental Biologics License Application to FDA for adult growth hormone deficiency (GHD), in the second quarter of 2024.
Topline results from Phase 2 trial in Turner syndrome expected in the fourth quarter of 2024.
TransCon PTH:
(palopegteriparatide, approved as YORVIPATH in the EU)
Launch of TransCon PTH underway with full commercial availability in Germany and Austria.
In the U.S., Prescription Drug User Fee Act (PDUFA) date of May 14, 2024; if approved, U.S. commercial launch planned in the third quarter of 2024.
TransCon CNP:
(navepegritide)
First patient enrolled in Phase 2 reACHin Trial in infants with achondroplasia (age 0-2 years). Estimated total enrollment of 72 patients.
Topline data from pivotal ApproaCH Trial expected in the fourth quarter of 2024, and plan to submit a New Drug Application to FDA for children with achondroplasia (age 2-11 years) in the same quarter.
Topline data from Week 26 of the COACH Trial (TransCon hGH/TransCon CNP combination) expected in children with achondroplasia (age 2-11 years) in the fourth quarter of 2024.
During the fourth quarter of 2024, plan to submit an Investigational New Drug application or similar in adults with achondroplasia.
TransCon IL-2 β/γ:
(onvapegleukin alfa)
During the fourth quarter of 2024, plan to provide a clinical update from the Phase 2 portion of indication-specific, dose expansion cohorts in the IL Believe trial.
TransCon TLR7/8 Agonist:
During the fourth quarter of 2024, plan to provide a clinical update from the Phase 2 portion of indication-specific, dose expansion cohorts in the transcendIT-101 trial.
Ophthalmology
In January 2024, announced the formation and launch of Eyconis, Inc., a separate company created to develop, manufacture, and commercialize TransCon ophthalmology assets globally.
Financial Update and Outlook Based on Current Plans
Ended 2023 with cash, cash equivalents, and marketable securities totaling €399 million.
Full year 2024 SKYTROFA revenue expected to be €320 million to €340 million (based on average 2023 exchange rates).
Expect total operating expenses (SG&A and R&D) of approximately €600 million for 2024.
Expect to be operating cash flow breakeven on a quarterly basis by the end of 2024.
Fourth Quarter and Full Year 2023 Financial Results
Total revenue for the fourth quarter of 2023 was €137.7 million compared to €22.9 million during the same period for 2022. The increase was primarily attributable to the $70.0 million upfront payment from Teijin, reported in license revenue and higher SKYTROFA revenue of €64.2 million compared to €17.1 million in the same period last year. Total revenue for 2023 was €266.7 million compared to €51.2 million in 2022. The increase was primarily attributable to higher SKYTROFA revenue of €178.7 million in 2023 compared to €35.7 million last year and the $70.0 million upfront payment from Teijin, reported in license revenue.

Research and development (R&D) costs for the fourth quarter were €90.9 million compared to €108.6 million during the same period in 2022. The decrease was tied to lower external development costs for TransCon hGH and Oncology programs. R&D costs for 2023 were €413.5 million compared to €379.6 million in 2022. The higher R&D costs in 2023 reflect an increase in TransCon CNP, Oncology and Ophthalmology program development activities and an increase in employee related costs attributable to organizational growth, partially offset by lower TransCon hGH program development costs.

Selling, general, and administrative (SG&A) expenses for the fourth quarter were €64.0 million compared to €56.6 million during the same period in 2022. This increase was primarily due to higher employee related expenses attributable to organizational growth. SG&A expenses for 2023 were €264.4 million compared to €221.2 million in 2022. Higher SG&A expenses were primarily due to organizational growth including commercial personnel to support existing SKYTROFA sales in the U.S. and Germany, and in preparation for future product launches.

Total operating expenses for the fourth quarter were €154.9 million compared to €165.2 million during the same period in 2022. Total operating expenses for 2023 were €677.9 million compared to €600.9 million in 2022.

Net finance expenses were €41.6 million in the fourth quarter compared to €46.7 million in the same period in 2022. Net finance expenses were €0.2 million in 2023 compared to a net finance income of €1.7 million in 2022.

For the fourth quarter of 2023, Ascendis Pharma reported a net loss of €86.9 million, or €1.54 per share (basic and diluted) compared to a net loss of €207.4 million, or €3.71 per share (basic and diluted) for the same period in 2022. For the full year 2023, Ascendis Pharma reported a net loss of €481.4 million, or €8.55 per share (basic and diluted) compared to a net loss of €583.2 million, or €10.40 per share (basic and diluted) in 2022.

As of December 31, 2023, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling €399.4 million compared to €742.9 million as of December 31, 2022. As of December 31, 2023, Ascendis Pharma had 57,707,439 ordinary shares outstanding, including 1,093,054 ordinary shares represented by ADSs held by the company.

Conference Call and Webcast Information
Ascendis Pharma will also host a conference call and webcast today at 4:30 p.m. Eastern Time (ET) to discuss 2023 financial results.

Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at View Source A replay of the webcast will be available on this section of the Ascendis Pharma website shortly after conclusion of the event for 30 days.

On February 7, 2024 Ascendis Pharma A/S (Nasdaq: ASND) reported that company executives will participate in the Oppenheimer 34th Annual Healthcare Life Sciences Conference (Press release, Ascendis Pharma, FEB 7, 2024, View Source [SID1234639903]).

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Details:

Event Oppenheimer 34th Annual Healthcare Life Sciences Conference
Location Virtual
Date Tuesday, February 13, 2024
Time 4:00 p.m. Eastern Time / 1:00 p.m. Pacific Time

A live webcast of the event will be available via the Investors & News section of the Ascendis Pharma website at investors.ascendispharma.com. A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.