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CHMP Issues Positive Opinion for Subcutaneous RYBREVANT®(amivantamab) Co-Formulated with ENHANZE® for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer

On February 3, 2025 Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) reported that Janssen-Cilag International NV, a Johnson & Johnson company, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending an extension of marketing authorisation for a subcutaneous (SC) formulation of RYBREVANT (amivantamab) in combination with LAZCLUZE (lazertinib) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy (Press release, Halozyme, FEB 3, 2025, View Source [SID1234650008]).

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"We are pleased that the subcutaneous formulation of amivantamab, which was developed with our ENHANZE drug delivery technology, was recommended for approval in Europe," said Dr. Helen Torley, president and chief executive officer of Halozyme. "The data that support the recommendation could represent a very compelling proposition for patients with the approximate five-minute administration time and five-fold reduction in infusion related reactions."

The CHMP positive opinion is supported by positive results from the Phase 3 PALOMA-3 study (NCT05388669). For more information on the study and its findings, please view Johnson & Johnson’s press release issued today.

Subcutaneous amivantamab is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.

1 Leighl NB et al. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor–Mutated Non–Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. ASCO (Free ASCO Whitepaper) Journal of Clinical Oncology. 2024;42(3):3593-3605.

2 Leighl NB, et al. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. J Clin Oncol. 2024 Oct 20;42(30):3593-3605.

3 ClinicalTrials.gov. A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (PALOMA-3). View Source Accessed January 2025.

Imfinzi recommended for approval in the EU by CHMP as first and only immunotherapy for limited-stage small cell lung cancer

On February 3, 2025 AstraZeneca reported that Imfinzi (durvalumab) has been recommended for approval in the European Union (EU) as monotherapy for the treatment of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT) (Press release, AstraZeneca, FEB 3, 2025, View Source [SID1234650007]).

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on the results from the ADRIATIC Phase III trial, which were published in The New England Journal of Medicine.

Results showed Imfinzi reduced the risk of death by 27% versus placebo (based on an overall survival [OS] hazard ratio [HR] of 0.73; 95% confidence interval [CI] 0.57-0.93; p=0.0104). Estimated median OS was 55.9 months for Imfinzi versus 33.4 months for placebo. An estimated 57% of patients treated with Imfinzi were alive at three years compared to 48% for placebo.

Imfinzi also reduced the risk of disease progression or death by 24% (based on a progression-free survival [PFS] HR of 0.76; 95% CI 0.61-0.95; p=0.0161) versus placebo. Median PFS was 16.6 months for Imfinzi versus 9.2 months for placebo. An estimated 46% of patients treated with Imfinzi had not experienced disease progression at two years compared to 34% for placebo.

SCLC is a highly aggressive form of lung cancer.1 LS-SCLC typically recurs and progresses rapidly, despite initial response to standard-of-care chemotherapy and radiotherapy.2-3 The prognosis for LS-SCLC is particularly poor, as only 15-30% of patients will be alive five years after diagnosis.4

Suresh Senan, PhD, Professor of Clinical Experimental Radiotherapy at the Amsterdam University Medical Centers, The Netherlands, and principal investigator in the trial, said: "ADRIATIC was the first Phase III trial in decades to demonstrate a survival benefit in limited-stage small cell lung cancer, reducing the risk of death by 27 per cent in patients treated with durvalumab versus placebo. Today’s positive recommendation from the CHMP means that our patients in Europe are one step closer to gaining access to this practice-changing treatment regimen."

Susan Galbraith, Executive Vice President, Oncology Haematology, R&D, AstraZeneca, said: "With 57 per cent of patients still alive at three years in the ADRIATIC trial, Imfinzi has the potential to transform treatment for people with limited-stage small cell lung cancer. If approved, these patients will have access to immunotherapy for the first time, redefining expectations of survival outcomes in this setting."

The safety profile for Imfinzi was generally manageable and consistent with the known profile of this medicine. No new safety signals were observed.

Imfinzi is approved in the US and several other countries in this setting based on the ADRIATIC results. Regulatory applications are currently under review in Japan and several other countries in this indication.

Notes

Small cell lung cancer
Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.5-6 Lung cancer is broadly split into non-small cell lung cancer (NSCLC) and SCLC, with about 15% of cases classified as SCLC.7

LS-SCLC (Stage I-III) is classified as SCLC that is generally only in one lung or one side of the chest.8 LS-SCLC accounts for approximately 30% of SCLC diagnoses, with an estimated 8,000 people treated for LS-SCLC across the five major European countries each year.9-10 The prognosis for patients with LS-SCLC remains poor despite curative-intent treatment with standard-of-care concurrent CRT (cCRT).9

ADRIATIC
The ADRIATIC trial is a randomised, double-blind, placebo-controlled, multi-centre global Phase III trial evaluating Imfinzi monotherapy and Imfinzi plus Imjudo (tremelimumab) versus placebo in the treatment of 730 patients with LS-SCLC who had not progressed following cCRT. In the experimental arms, patients were randomised to receive a 1500mg fixed dose of Imfinzi with or without Imjudo 75mg every four weeks for up to four doses/cycles each, followed by Imfinzi every four weeks for up to 24 months.

The dual primary endpoints were PFS and OS for Imfinzi monotherapy versus placebo. Key secondary endpoints included OS and PFS for Imfinzi plus Imjudo versus placebo, safety and quality of life measures. The trial included 164 centres in 19 countries across North and South America, Europe and Asia.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

In addition to its indication in LS-SCLC, Imfinzi is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after CRT. Additionally, Imfinzi is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC; in combination with chemotherapy (etoposide and either carboplatin or cisplatin) for the treatment of extensive-stage SCLC; and in combination with a short course of Imjudo and chemotherapy for the treatment of metastatic NSCLC.

Imfinzi is also approved in combination with chemotherapy (gemcitabine plus cisplatin) in locally advanced or metastatic biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU.

Imfinzi is also approved in combination with chemotherapy (carboplatin and paclitaxel) followed by Imfinzi monotherapy in primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) in the US. In the EU, Imfinzi plus chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient (pMMR) advanced or recurrent endometrial cancer, and Imfinzi plus chemotherapy followed by Imfinzi alone is approved for patients with dMMR disease. In Japan, Imfinzi plus chemotherapy followed by Imfinzi monotherapy has also been approved as 1st-line treatment in primary advanced or recurrent endometrial cancer, and Imfinzi plus chemotherapy followed by Imfinzi and Lynparza has been approved for patients with pMMR disease.

Since the first approval in May 2017, more than 374,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, breast cancer, several gastrointestinal and gynaecologic cancers, and other solid tumours.

Bavarian Nordic Reports Preliminary 2024 Financial Results in Line with Upgraded Guidance and Guides for 2025

On February 3, 2025 Bavarian Nordic A/S (OMX: BAVA) reported preliminary, unaudited financial results for 2024 and provided its financial guidance for 2025 (Press release, Bavarian Nordic, FEB 3, 2025, View Source [SID1234650006]).

The preliminary revenue in 2024 was DKK 5,716 million and was comprised of the following:

Revenue from Public Preparedness was DKK 3,206 million, reaching the midpoint of the guided interval of DKK 3,000 – 3,400 million. This is more than 1,000 million above the projected base business and reflects another spike year of sales, as the Company addressed the second public health emergency for mpox.
Revenue from Travel Health increased by 22% to DKK 2,287 million, compared to a guidance of DKK 2,200 million. The strong performance was in particular driven by Rabipur/RabAvert and Encepur.
Other revenue totaled DKK 223 million.
The preliminary operating result (EBITDA) was a profit of DKK 1,603 million, corresponding to an EBITDA-margin of 28%, in line with the guided interval of DKK 1,450 – 1,700 million and a margin of 27-29%.

"We delivered strong results in 2024 after an extraordinary performance in our Travel Health business, demonstrating a 22% growth year-over-year, combined with additional mpox vaccine orders, as we made significant strides in strengthening the public health response in Africa and other regions during the current outbreak. Thus, we exceeded our base projections for the Public Preparedness business, which will continue into 2025," said Paul Chaplin, President and CEO of Bavarian Nordic. "Our portfolio continues to grow, and we are truly excited to launch our chikungunya vaccine for travelers over 12 years in both Europe and the US later this year, while also continuing to expand our partnerships to improve access to critical vaccines for vulnerable populations around the globe. Looking into 2025, we have other important milestones in sight, including the completion of the tech transfer of the rabies and TBE vaccines, as well as the payment of the final considerations for our recent acquisitions, which will further strengthen our financial position and flexibility going forward."

The consolidated, audited financial results for 2024 will become available on March 5, 2025, in connection with the publication of the Company’s Annual Report for 2024.

DKK million

FY 2024 guidance
original, 21-Feb-2024

FY 2024 guidance

latest, 26-Sep-2024

FY 2024 actuals
preliminary, unaudited

Revenue

5,000 – 5,300

5,400 – 5,800

5,716

EBITDA

1,100 – 1,350

1,450 – 1,700

1,603

2025 financial guidance
For 2025, Bavarian Nordic expects revenue of DKK 5,700 – 6,700 million and an EBITDA-margin of 26-30%.

DKK million

FY 2025 guidance

Revenue

5,700 – 6,700

EBITDA-margin

26% – 30%

The expected revenue is comprised of DKK 3,000 – 4,000 million from Public Preparedness vaccines, of which DKK 2,500 million have already been secured by contracts. Furthermore, approximately DKK 2,500 million from Travel Health vaccines, and approximately DKK 200 million from contract work are expected.

Travel Health revenue includes DKK 50 – 100 million from the sale of chikungunya vaccines, which is expected to be launched in the US and key European markets later in 2025, pending regulatory approval.

As communicated in early 2024, Bavarian Nordic expects an average annual growth of 10-12% in Travel Health during 2023-2027, and a Public Preparedness base business of DKK 1,500 – 2,000 million annually. With 22% growth in 2024 and the additional growth expected in 2025 for Travel Health combined with the current order book for Public Preparedness, the Company is currently ahead of these ambitions.

The normal seasonality of the Travel Health business and the timing of revenue recognition of orders from Public Preparedness will cause variability in revenue and EBITDA throughout the year, with the first quarter of 2025 being light.

Research and development costs of approximately DKK 900 million are expected, which include cost for life-cycle management of the growing commercial portfolio, including additional studies of the chikungunya vaccine as agreed with the regulatory authorities as well as the advancement of early-stage pipeline assets.

CAPEX is expected at approximately DKK 250 million whereas inventory levels are anticipated to be relatively unchanged.

The outlook is based on the following assumptions on currency exchange rates of DKK 7.00 per 1 USD and DKK 7.45 per 1 EUR.

OmniAb to Participate in Two Investor Conferences in March

On February 3, 2025 OmniAb, Inc. (NASDAQ: OABI) reported that management will be participating in two investor conferences during the month of March (Press release, OmniAb, FEB 3, 2025, View Source [SID1234650004]).

TD Cowen 45th Annual Health Care Conference, March 3-5 at the Boston Marriott Copley Place. Management will be presenting a corporate overview on Tuesday, March 4that 2:30 p.m. Eastern time and will be holding one-on-one meetings with investors.
2025 Leerink Partners Global Healthcare Conference, March 9-12 at the W Hotel South Beach in Miami.Management will hold one-on-one meetings with investors on Wednesday, March 12th.

Twist Bioscience Reports Fiscal First Quarter 2025 Financial Results

On February 3, 2025 Twist Bioscience Corporation (NASDAQ: TWST), a core mid-cap growth and value equity company in the life sciences segment of the health care sector, reported financial results and business highlights for the first quarter of fiscal 2025 ended December 31, 2024 (Press release, Twist Bioscience, FEB 3, 2025, View Source [SID1234650003]).

"We ended the first quarter of fiscal 2025 with our eighth consecutive quarter of revenue growth and continued improvement in gross margin. We’re starting the fiscal year strong, demonstrating our unwavering commitment to progressing toward adjusted EBITDA breakeven," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience.

Dr. Leproust continued, "As we move through 2025, we are pursuing multiple growth vectors that we believe will help us to achieve adjusted EBITDA breakeven and then build on our foundation to drive sustainable growth in the years to come. Importantly, we expect to exit the fourth quarter of fiscal 2025 with gross margin over 50%."

See "Non-GAAP Information" below for a discussion of the measure adjusted EBITDA.

FISCAL 2025 FIRST QUARTER FINANCIAL RESULTS

•Revenue: Total revenues for the first quarter of fiscal 2025 grew to $88.7 million compared to $71.5 million for the same period of fiscal 2024.
◦SynBio revenue grew 28% to $34.4 million for the first quarter of fiscal 2025 compared to $26.9 million for the same period of fiscal 2024.
◦NGS revenue grew 23% to $48.6 million for the first quarter of fiscal 2025 compared to $39.4 million for the same period of fiscal 2024.
◦Biopharma revenue was $5.7 million for the first quarter of fiscal 2025 compared to $5.2 million in the same period of fiscal 2024.
•Cost of Revenues: Cost of revenues for the first quarter of fiscal 2025 was $45.9 million compared to $42.5 million for the same period of fiscal 2024.
•Gross Margin: Gross margin for the first quarter of fiscal 2025 increased to 48.3% compared to 40.5% for the same period of fiscal 2024.

•Research and Development Expenses: Research and development expenses for the first quarter of fiscal 2025 were $21.3 million compared to $23.1 million for the same period of fiscal 2024.
•Selling, General and Administrative Expenses: Selling, general and administrative expenses for the first quarter of fiscal 2025 were $56.2 million compared to $52.8 million for the same period of fiscal 2024.
•Net Loss: Net loss attributable to common stockholders for the first quarter of fiscal 2025 was $31.6 million, or $0.53 per share, compared to $43.0 million, or $0.75 per share, for the same period of fiscal 2024.
•Adjusted EBITDA: Adjusted EBITDA for the first quarter of fiscal 2025 was $(16.3) million compared to $(27.8) million for the same period of fiscal 2024. See the table included in this release for a reconciliation between our adjusted EBITDA and net loss attributable to common stockholders, the most directly comparable GAAP financial measure.
•Cash Position: As of December 31, 2024, the company had $270.8 million in cash, cash equivalents and short-term investments.

Recent Highlights:

•Shipped products to approximately 2,376 customers in the first quarter of fiscal 2025, versus approximately 2,140 customers in the first quarter of fiscal 2024.
•Shipped approximately 205,000 genes during the first quarter of fiscal 2025, compared with approximately 171,000 genes during the first quarter of fiscal 2024.

Updated Fiscal 2025 Financial Guidance

The following statements are based on Twist’s current expectations for fiscal 2025, including the second quarter of fiscal 2025. The following statements are forward-looking, and actual results could differ materially depending on market conditions and the factors set forth under "Forward-Looking Statements" below.

For the full fiscal year 2025, Twist expects:

•Total revenue to be in the range of $372 million to $379 million compared to the previous guidance of $367 million to $377 million, indicating growth of 19 to 21 percent year over year, including:
◦SynBio revenue of $144 million to $147 million, compared to previous guidance of $142 million to $146 million, growth of 17 to 18 percent
◦NGS revenue of $205 million to $209 million, compared to previous guidance of $204 million to $209 million, growth of 21 to 24 percent

◦Biopharma revenue of $23 million, compared to previous guidance of $21 million to $22 million, growth of 13 percent
•Gross margin is projected to be approximately 49% for fiscal 2025 with quarterly sequential improvements, compared to previous guidance of 48% and 4QFY25 gross margin is projected to be over 50%
•Adjusted EBITDA of approximately $(55) million to $(60) million for fiscal 2025 compared to previous guidance of $(60) million to $(65) million

For the second quarter, Twist expects:

•Total revenue of approximately $91 million to $93 million, growth of 21 to 24 percent year over year
•SynBio revenue of approximately $35.5 million to $36 million, growth of approximately 19 to 21 percent year over year
•NGS revenue of approximately $50 million to $51 million, growth of 23 to 25 percent year over year
•Biopharma revenue of approximately $5.5 million to $6.0 million
•Adjusted EBITDA of approximately $(16) million with sequential improvements throughout 2025

Non-GAAP Information

This release includes EBITDA and adjusted EBITDA, which are non-GAAP financial measures, for the periods presented. EBITDA is defined as net loss adjusted to exclude interest income, interest expense, income tax expense and depreciation and amortization. Adjusted EBITDA is defined as net loss adjusted to exclude interest income, interest expense, income tax expense, depreciation and amortization, other income/expense, net and stock-based compensation expense detailed in the reconciliation table below that we believe are not indicative of our ongoing results. These non-GAAP measures are not in accordance with, or an alternative for, measures prepared in accordance with generally accepted accounting principles (GAAP) and may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Management believes that these non-GAAP financial measures, when considered together with our financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare our results from period to period and to our forward-looking guidance, and to identify operating trends in our business. However, non-GAAP information is not superior to financial measures calculated in accordance with GAAP, is presented for supplemental informational purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with GAAP. A reconciliation table of the most comparable GAAP financial measure to the non-GAAP financial measures is included at the end of this press release.

A reconciliation of adjusted EBITDA for fiscal 2025 and the second quarter of fiscal 2025 to a corresponding GAAP financial guidance measure is not available on a forward-looking basis because the Company does not provide guidance on GAAP net loss and is not able to present the various reconciling cash and non-cash items between GAAP net loss and adjusted EBITDA without unreasonable effort. In particular, stock-based compensation expense is impacted by the Company’s future hiring and retention needs, as well as the future fair market value of its common stock, all of which is difficult to predict and is subject to change. The actual amount of these expenses during fiscal 2025 and the second quarter of fiscal 2025 will have a significant impact on Twist’s future GAAP financial results.

Conference Call Information

The company plans to hold a conference call and live audio webcast for analysts and investors at 8:00 a.m. Eastern Time today to discuss its financial results and provide an update on the company’s business. The conference call will be webcast live through the Investor Relations section under the "Company" tab at www.twistbioscience.com. Those parties interested in participating via telephone must register on the Company’s Investor Relations website. Upon registration, all telephone participants will receive the dial-in number along with a unique PIN number that can be used to access the call. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. The webcast replay will be available for two weeks.