Temozolomide

Quarterly net revenues of $139 million, up 13% year-over-year, with 3,845 active patients on therapy as of March 31, 2024 Phase 3 METIS trial in brain metastases from non-small cell lung cancer met primary endpoint and will be presented as late-breaking abstract at ASCO 2024 LUNAR PMA application for TTFields in NSCLC Day 100 FDA meeting complete ROOT, Switzerland--(BUSINESS WIRE)--NovoCure Ltd. (NASDAQ: NVCR) today reported financial results for the quarter ended March 31, 2024. Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields). “The first quarter was a period of strong execution,” said William Doyle, Novocure’s Executive Chairman. “In Q1, GBM active patients grew 11%, we announced the METIS Phase 3 clinical trial met its primary endpoint, and we met with the U.S. Food and Drug Administration (FDA) in a Day-100 meeting for the LUNAR PMA application. We have multiple milestones ahead of us in 2024, and I remain grateful for our teams’ dedication and hard work.” Financial updates for the first quarter ended March 31, 2024: Total net revenues for the quarter were $138.5 million, an increase of 13% compared to the same period in 2023. This increase was primarily driven by our successful launch in France and improved U.S. approval rates. The United States, Germany and Japan contributed $90.5 million, $15.7 million and $7.8 million, respectively, with other active markets contributing $19.5 million. Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $4.9 million. Gross margin for the quarter was 76%. Research, development, and clinical studies expenses for the quarter were $51.6 million, a decrease of 14% from the same period in 2023. This primarily reflects decreased personnel expenses and reduced direct clinical trial expenses driven by the timing of activities within the clinical trial portfolio. Sales and marketing expenses for the quarter were $55.2 million, an increase of 8% compared to the same period in 2023. This primarily reflects sales force expansion and increased marketing activities in anticipation of our potential launch in non-small cell lung cancer. General and administrative expenses for the quarter were $39.5 million, a decrease of 6% compared to the same period in 2023. This primarily reflects lower personnel expenses. Net loss for the quarter was $38.8 million with loss per share of $0.36. Adjusted EBITDA* for the quarter was $(4.6) million. Cash, cash equivalents and short-term investments were $870 million as of March 31, 2024. In May, we entered into a new five-year senior secured credit facility agreement with affiliates of Pharmakon Advisors for up to $400 million, drawn across up to four tranches of $100 million. This non-dilutive, multi-tranche, delayed-draw, debt facility strengthens our cash position and further solidifies our balance sheet while providing valuable flexibility as we invest in our future. Operational updates for the first quarter ended March 31, 2024: 1,643 prescriptions were received in the quarter, an increase of 10% compared to the same period in 2023. Prescriptions from the United States, Germany and Japan contributed 990, 206 and 91 prescriptions, respectively, with the remaining 356 prescriptions received in other active markets. As of March 31, 2024, there were 3,845 active patients on therapy. Active patients from the United States, Germany and Japan contributed 2,137, 540 and 379 active patients, respectively, with the remaining 789 active patients contributed by other active markets. Quarterly updates and achievements: In April, we met with the FDA in a Day-100 meeting for the PMA application for Optune Lua in non-small cell lung cancer (NSCLC). The meeting was productive with no indication that the PMA will be referred to an advisory panel. We continue to anticipate the PMA decision in the second half of 2024. In March 2024, we announced the METIS Phase 3 clinical trial met its primary endpoint, demonstrating a statistically significant extension in time to intracranial progression for patients with brain metastases from NSCLC. The METIS trial data will be presented as a late-breaking abstract at the upcoming American Society of Clinical Oncology (ASCO) scientific congress in June. In March, the FDA approved the Investigational New Drug (IND) application for the randomized, Phase 3 KEYNOTE D58 trial. KEYNOTE D58 will explore the use of TTFields therapy together with temozolomide and the immunotherapy pembrolizumab for the treatment of newly diagnosed glioblastoma. In March, an exploratory subgroup analysis of the randomized, Phase 3 INNOVATE-3 trial was selected as a Best Oral Presentation at the European Society of Gynaecological Oncology 2024 Congress. The exploratory analysis found that pegylated liposomal doxorubicin (PLD) -naïve patients randomized to receive TTFields therapy and paclitaxel exhibited median overall survival of 16.0 months compared to 11.7 months in PLD-naïve patients treated with paclitaxel alone. Anticipated 2024 clinical milestones: Top-line data from Phase 3 PANOVA-3 clinical trial in locally advanced pancreatic cancer (Q4 2024) Conference call details Novocure will host a conference call and webcast to discuss first quarter 2024 financial results at 8:00 a.m. EDT today, Thursday, May 2, 2024. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link. The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, , and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. About Novocure Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma, malignant pleural mesothelioma and pleural mesothelioma. Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer. Headquartered in Root, Switzerland and with a growing global footprint, Novocure has regional operating centers in Portsmouth, New Hampshire and Tokyo, as well as a research center in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and Twitter. *Non-GAAP Financial Measurements We measure our performance based upon a non-U.S. GAAP measurement of earnings before interest, taxes, depreciation, amortization and shared-based compensation ("Adjusted EBITDA"). We believe Adjusted EBITDA is useful to investors in evaluating our operating performance because it helps investors compare the results of our operations from period to period by removing the impact of earnings attributable to our capital structure, tax rate and material non-cash items, specifically share-based compensation. Forward-Looking Statements In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical trial progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 22, 2024, and subsequent filings with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion. Consolidated Statements of Operations USD in thousands (except share and per share data) Three months ended March 31, Year ended December 31, 2024 2023 2023 Unaudited Audited Net revenues $ 138,503 $ 122,182 $ 509,338 Cost of revenues 33,689 29,614 128,280 Gross profit 104,814 92,568 381,058 Operating costs and expenses: Research, development and clinical studies 51,598 59,704 223,062 Sales and marketing 55,206 51,169 226,809 General and administrative 39,530 41,944 164,057 Total operating costs and expenses 146,334 152,817 613,928 Operating income (loss) (41,520 ) (60,249 ) (232,870 ) Financial income (expenses), net 9,878 9,169 41,130 Income (loss) before income taxes (31,642 ) (51,080 ) (191,740 ) Income taxes 7,118 1,981 15,303 Net income (loss) $ (38,760 ) $ (53,061 ) $ (207,043 ) Basic and diluted net income (loss) per ordinary share $ (0.36 ) $ (0.50 ) $ (1.95 ) Weighted average number of ordinary shares used in computing basic and diluted net income (loss) per share 107,266,198 105,667,072 106,391,178 Consolidated Balance Sheets USD in thousands (except share data) March 31, 2024 December 31, 2023 Unaudited Audited ASSETS CURRENT ASSETS: Cash and cash equivalents $ 453,763 $ 240,821 Short-term investments 416,384 669,795 Restricted cash 3,600 1,743 Trade receivables, net 65,091 61,221 Receivables and prepaid expenses 21,479 22,677 Inventories 42,391 38,152 Total current assets 1,002,708 1,034,409 LONG-TERM ASSETS: Property and equipment, net 58,917 51,479 Field equipment, net 11,911 11,384 Right-of-use assets 32,994 34,835 Other long-term assets 14,899 14,022 Total long-term assets 118,721 111,720 TOTAL ASSETS $ 1,121,429 $ 1,146,129 Consolidated Balance Sheets USD in thousands (except share data) March 31, 2024 December 31, 2023 Unaudited Audited LIABILITIES AND SHAREHOLDERS' EQUITY CURRENT LIABILITIES: Trade payables $ 84,316 $ 94,391 Other payables, lease liabilities and accrued expenses 75,914 84,724 Total current liabilities 160,230 179,115 LONG-TERM LIABILITIES: Long-term debt, net 569,652 568,822 Long-term leases 25,608 27,420 Employee benefit liabilities 6,566 8,258 Other long-term liabilities 18 18 Total long-term liabilities 601,844 604,518 TOTAL LIABILITIES 762,074 783,633 COMMITMENTS AND CONTINGENCIES SHAREHOLDERS' EQUITY: Share capital - Ordinary shares no par value, unlimited shares authorized; issued and outstanding: 107,603,774 shares and 107,075,754 shares at March 31, 2024 (unaudited) and December 31, 2023, respectively — — Additional paid-in capital 1,387,765 1,353,468 Accumulated other comprehensive income (loss) (4,147 ) (5,469 ) Retained earnings (accumulated deficit) (1,024,263 ) (985,503 ) TOTAL SHAREHOLDERS' EQUITY 359,355 362,496 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 1,121,429 $ 1,146,129 Non-U.S. GAAP financial measures reconciliation USD in thousands Three months ended March 31, 2024 2023 % Change Net income (loss) $ (38,760 ) $ (53,061 ) (27 )% Add: Income tax 7,118 1,981 259 % Add: Financial expenses (income), net (9,878 ) (9,169 ) 8 % Add: Depreciation and amortization 2,815 2,722 3 % EBITDA $ (38,705 ) $ (57,527 ) (33 )% Add: Share-based compensation 34,084 39,084 (13 )% Adjusted EBITDA $ (4,621 ) $ (18,443 ) (75 )%

SAN DIEGO, April 30, 2024 /PRNewswire/ -- Denovo Biopharma LLC (Denovo), a pioneer in applying precision medicine to the development of innovative therapies, today announced that the California Institute for Regenerative Medicine (CIRM) has awarded a $11.8M grant for further development of DB107, Denovo's DGM7™ biomarker–guided late–stage gene therapy, for high–grade glioma (HGG) including glioblastoma (GBM), a malignant brain cancer. CIRM has awarded the grant to Dr. Noriyuki Kasahara, MD, PhD, at the University of California San Francisco (UCSF) and a group of investigators at California universities to conduct a Phase 1/2 clinical trial studying DB107 in patients with newly–diagnosed HGG. Continue Reading The trial, titled "A Phase I/IIa Study to Evaluate the Efficacy of DB107–RRV, Administered to Subjects at Time of Resection and Intravenously Thereafter, in Combination with DB107–FC and Radiation Therapy or DB107–FC, Temozolomide (TMZ) and Radiation Therapy in Patients with Newly–Diagnosed High–Grade Glioma," plans to enroll up to 70 patients. The trial aims to demonstrate improvements in progression–free survival. We are thrilled to continue the clinical development of our biomarker-guided DB107 gene therapy in HGG including GBM. Post this DB107 consists of two components: DB107–RRV (vocimagene amiretrorepvec) as a prodrug activator gene therapy and DB107–FC (extended-release 5–fluorocytosine [5–FC]) as an oral prodrug. DB107–RRV, a retroviral replicating vector (RRV) administered intratumorally and intravenously, converts the orally administered 5–FC into the potent chemotherapy agent 5–fluorouracil (5–FU) locally at the tumor sites. This enables intratumoral concentrations 30–50 times of those achievable by 5–FU systemic administration, killing tumor cells while minimizing the systemic exposure and off–target toxicities of 5–FU. Using its proprietary biomarker discovery platform including whole genome sequencing (WGS) and artificial intelligence (AI), Denovo discovered the novel germline genetic biomarker, Denovo Genomic Marker 7 (DGM7), which is located in the SHROOM3 gene intron. Retrospective analysis of an earlier randomized clinical trial in patients with recurrent HGG suggested improved overall survival in DGM7–positive patients treated with DB107. "We are excited to conduct this novel trial which will be investigating several new approaches for the first time in patients with newly–diagnosed high–grade glioma. In addition to DB107–RRV being administered both intratumorally and intravenously to provide more exposure, this study will also use the RRV in conjunction with radiation therapy and chemotherapy with temozolomide. In addition to the direct therapeutic effect of gene therapy, glioma cells will be sensitized to these standard therapies by 5–FU generated directly within the patient's tumor from DB107–FC. We are also excited to test the DGM7 biomarker to see if we can identify patients who may benefit the most from this unique gene therapy approach," said Dr. Kasahara. DGM7 status will be determined at the time of enrollment to prospectively assess the effect of the biomarker on clinical outcomes. The study will be conducted at UCSF (Dr. Noriyuki Kasahara, MD, PhD, and Dr. Nicholas Butowski, MD), University of Southern California (USC) (Dr. Thomas Chen, MD, PhD), and University of California San Diego (UCSD) (Dr. David Piccioni, MD, PhD), and will be managed by Anova Enterprises, Inc. "We are thrilled to continue the clinical development of our biomarker–guided DB107 gene therapy in patients with HGG including GBM, a major unmet medical need with less than 5% of GBM patients surviving 5 years," said Dr. Matthew A. Spear, MD, Denovo's Chief Medical Officer and Chief Development Officer. "Alongside our recent announcement of positive results in a Phase 2b clinical trial of our DGM4 biomarker–guided DB104 drug (liafensine) in treatment–resistant depression, the CIRM grant provides continued validation of Denovo's approach to discovering new genetic biomarkers and developing biomarker–guided therapies." About HGG and GBM The most common type of high–grade glioma (HGG) is glioblastoma (GBM), which is also the most common type of adult primary brain cancer, with 18,000 newly–diagnosed patients in the US and 13,000 deaths annually. Standard treatments for patients with newly–diagnosed GBM can include surgery followed by radiation and chemotherapy, but treatment options are limited. The 5–year survival rate of patients with GBM is less than 5%. About DB107 and the DGM7™ Biomarker DB107 is an investigational combination product consisting of the DB107–RRV (vocimagene amiretrorepvec) gene therapy and DB107–FC (extended–release 5–fluorocytosine) oral prodrug. DB107–RRV, an innovative proprietary retroviral replicating vector (RRV), is combined with DB107–FC to selectively infect and kill cancer cells while stimulating a robust and durable anti–cancer immune response against a tumor with minimal toxicity. DB107 has been tested clinically in solid tumors including recurrent high–grade glioma (rHGG) and colorectal cancer, most recently in a randomized 403–patient Phase 2/3 trial in rHGG including glioblastoma (GBM). Using its proprietary biomarker discovery platform, Denovo discovered the novel genetic biomarker, DGM7, which has been shown to be associated with treatment response to DB107 in patients with rHGG including GBM. DB107 has received Fast Track Designation and Breakthrough Therapy Designation from the FDA, as well as Orphan Drug Designations from the FDA and EMA. About Denovo Biopharma Denovo Biopharma LLC (Denovo) is a clinical–stage biopharmaceutical company that uses a novel biomarker discovery platform including whole genome sequencing (WGS) and artificial intelligence (AI) to find new genetic biomarkers predictive of drug efficacy, and then uses these biomarkers to execute efficient clinical trials in targeted patient populations to increase the probability of success. Denovo has eight late–stage drugs in its pipeline addressing major unmet medical needs in oncology and central nervous system diseases; most of the pipeline are first–in–class drugs with global rights. Denovo recently announced a major breakthrough in treatment–resistant depression (TRD) with its DGM4™ biomarker–guided DB104 drug (liafensine, a potential first–in–class triple reuptake inhibitor for TRD). The global Phase 2b clinical trial of DB104 in DGM4–positive patients with TRD demonstrated strikingly positive results, with highly significant improvements in symptoms of depression seen in DGM4–positive patients. Visit for additional information. Contact Michael F. Haller, Chief Business Officer Denovo Biopharma LLC [email protected] SOURCE Denovo Biopharma LLC