On July 26, 2024, Aileron Therapeutics, Inc., a Delaware corporation (the "Company"), reported to have entered into an Equity Distribution Agreement (the "Agreement") with Citizens JMP Securities, LLC, as agent and/or principal (the "Agent"), pursuant to which the Company may offer and sell shares of its common stock, $0.001 par value per share, from time to time up to amounts to be determined through or to the Agent (the "Offering") (Filing, 8-K, Aileron Therapeutics, JUL 26, 2024, View Source [SID1234645102]). The Company filed a prospectus supplement with the Securities and Exchange Commission (the "SEC") to register shares of common stock having an aggregate offering price of up to $50,000,000 (the "Shares") in connection with the Offering (the "Prospectus Supplement") under the Company’s existing shelf Registration Statement on Form S-3 (File No. 333-265470) filed with the SEC on June 8, 2022, which became effective on June 16, 2022 (as it may be amended or supplemented, the "Registration Statement").

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Upon delivery of a placement notice to the Agent and subject to the terms and conditions of the Agreement, the Agent may sell the Shares in sales deemed to be "at the market offerings" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, including sales made directly on or through the Nasdaq Capital Market.

The Company or the Agent may suspend or terminate the offering of Shares upon notice to the other party, subject to certain conditions. The Agent is not required to sell any specific amount of Shares, but will act as sales agent using commercially reasonable efforts consistent with its normal sales and trading practices and applicable state and federal law, rules and regulations and the rules of The Nasdaq Stock Market LLC.

The Company has agreed to pay the Agent commissions for its services of acting as agent of 3.0% of the gross proceeds from the sale of the Shares pursuant to the Agreement. The Company has also agreed to provide the Agent with customary indemnification and contribution rights with respect to certain liabilities.

A copy of the Agreement is attached as Exhibit 1.1 hereto and is incorporated herein by reference. The foregoing description of the material terms of the Agreement is qualified in its entirety by reference to such exhibit.

Wilmer Cutler Pickering Hale and Dorr LLP, counsel to the Company, has issued a legal opinion relating to the Shares. A copy of such legal opinion, including the consent included therein, is attached as Exhibit 5.1 hereto.

The Shares will be sold pursuant to the Registration Statement, and offerings of the Shares will be made only by means of the Prospectus Supplement. This Current Report on Form 8-K shall not constitute an offer to sell or solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of such state or jurisdiction.

On July 26, 2024 Aptose biosciences presented its corporate presentation (Presentation, Aptose Biosciences, JUL 26, 2024, View Source [SID1234645103]).

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On July 26, 2024 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of PADCEV (enfortumab vedotin, an antibody-drug conjugate [ADC]) in combination with KEYTRUDA (pembrolizumab, a PD-1 inhibitor) for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer, who are eligible for platinum-containing chemotherapy (Press release, Astellas, JUL 26, 2024, View Source [SID1234645104]).

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Ahsan Arozullah, MD, MPH, Senior Vice President and Head of Oncology Development, Astellas
"Treatment options available to patients with unresectable or metastatic urothelial cancer are currently limited mainly to platinum-containing chemotherapy. The data underpinning the CHMP’s approval recommendation show that this combination could change how clinicians manage first-line treatment of this disease. We are delighted that the CHMP recognized the potential for enfortumab vedotin in combination with pembrolizumab as first-line treatment for patients with unresectable or metastatic urothelial cancer."

The positive CHMP opinion is based on data from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) which showed enfortumab vedotin in combination with pembrolizumab significantly extends overall survival (OS) and progression-free survival (PFS) compared to platinum-containing chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). Treatment with the combination resulted in a median OS of 31.5 months (95% CI: 25.4-NR) compared to 16.1 months (95% CI: 13.9-18.3) with chemotherapy, representing a 53% reduction in risk of death (Hazard Ratio [HR]=0.47; 95% Confidence Interval [CI]: 0.38-0.58; P<0.00001). The median PFS of 12.5 months (95% CI: 10.4-16.6) with the combination compared to 6.3 months (95% CI: 6.2-6.5) with chemotherapy represents a 55% reduction in the risk of cancer progression or death (HR=0.45; 95% CI: (0.38-0.54); P<0.00001). During the EV-302 trial, approximately 30% of patients completed treatment with chemotherapy and then went on to receive maintenance therapy with avelumab, a PD-L1 inhibitor, which is reflective of current real world clinical practice.1 Results were presented at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and published in the New England Journal of Medicine.

Europe has the highest rate of new bladder cancer cases in the world.3 Every year, more than 165,000 people are diagnosed with the disease in the European Union (EU), and it claims the lives of over 50,000 people.3

Not only does bladder cancer affect a person’s physical functioning throughout the disease journey, patients and caregivers also report significant impacts on quality of life and mental well-being which are often exacerbated by late detection and challenging pathways to diagnosis.4

The positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines in all 27 EU member states as well as Iceland, Liechtenstein and Norway.5

In December 2023, the U.S. Food and Drug Administration (FDA) approved enfortumab vedotin in combination with pembrolizumab for the treatment of adult patients with la/mUC.6 In April 2022, the EC approved enfortumab vedotin as a monotherapy for the treatment of adult patients with la/mUC who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.7

Astellas has already reflected the impact from this result in its financial forecast for the current fiscal year ending March 31, 2025.

For more information, please see the press release "European Medicines Agency Validates Type II Variation Application for PADCEV (enfortumab vedotin) with KEYTRUDA (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer" issued on January 29, 2024.

About EV-302
EV-302 is an ongoing, open-label, randomized, controlled Phase 3 trial, evaluating enfortumab vedotin in combination with pembrolizumab versus platinum-containing chemotherapy in patients with previously untreated la/mUC. The trial enrolled 886 patients with previously untreated la/mUC who were eligible for cisplatin- or carboplatin-containing chemotherapy regardless of PD-L1 status. Patients were randomized to receive either enfortumab vedotin in combination with pembrolizumab or platinum-containing chemotherapy. The dual primary endpoints of this trial are OS and PFS per RECIST v1.1 by blinded independent central review (BICR). Select secondary endpoints include ORR per RECIST v1.1 by BICR, DOR per RECIST v1.1 by BICR, and safety.1

The most common (≥3%) Grade 3 or higher adverse events related to treatment with enfortumab vedotin and pembrolizumab were maculo-papular rash, hyperglycemia, neutropenia, peripheral sensory neuropathy, diarrhea, and anemia. The safety results in EV-302 are consistent with those previously reported with this combination in EV-103 in cisplatin-ineligible patients with la/mUC. No new safety issues were identified.1

The EV-302 trial is part of an extensive clinical program evaluating this combination in multiple stages of urothelial cancer and other solid tumors. Findings from EV-302 were presented at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and were published in the New England Journal of Medicine.

For more information on the EV-302 trial (NCT04223856) go to View Source

About Bladder and Urothelial Cancer
Urothelial cancer, or bladder cancer, begins in the urothelial cells, which line the urethra, bladder, ureters, renal pelvis, and some other organs.8 Urothelial cancer accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter, and urethra.9,10 If cancer is not able to be treated with surgery, it is called unresectable.11 If cancer has spread to surrounding organs or muscles, it is called locally advanced disease.12 If cancer has spread to other parts of the body, it is called metastatic disease.13 Approximately 12% of cases are unresectable locally advanced or metastatic urothelial cancer at diagnosis.14

Bladder cancer is diagnosed in approximately 614,000 people and causes 220,000 deaths worldwide each year.15 In Europe, bladder cancer is the fifth most common cancer;16 more than 165,000 people are diagnosed with the disease in the EU each year.3 Continuous treatment and surveillance makes bladder cancer one of the most expensive cancer types over the lifetime of a patient and, in fact, have been shown to be the costliest cancer when compared to other malignancies.17

About PADCEV (enfortumab vedotin)
PADCEV (enfortumab vedotin) is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.7,18 Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4-expressing cells, followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).7

PADCEV is currently indicated in the EU as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor.7

Ongoing Investigational Trials
EV-302 (NCT04223856) is an open-label, randomized, controlled Phase 3 trial, evaluating enfortumab vedotin in combination with pembrolizumab versus platinum-containing chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC) who were eligible for cisplatin- or carboplatin-containing chemotherapy regardless of PD-L1 status.

EV-103 (NCT03288545) is an ongoing, multi-cohort, open-label, multicenter Phase 1b/2 trial investigating enfortumab vedotin alone or in combination with pembrolizumab and/or chemotherapy in first- or second-line settings in patients with la/mUC and in patients with muscle-invasive bladder cancer (MIBC).

EV-104 (NCT05014139) is a Phase 1 trial exploring enfortumab vedotin in patients with non-muscle invasive bladder cancer (NMIBC). The trial will be conducted in two-parts, assessing dose escalation and dose expansion with enfortumab vedotin when administered intravesically as a monotherapy.

Enfortumab vedotin in combination with pembrolizumab is being investigated in an extensive program in multiple stages of urothelial cancer, including two Phase 3 clinical trials in MIBC in EV-304 (NCT04700124, also known as KEYNOTE-B15) and EV-303 (NCT03924895, also known as KEYNOTE-905). The use of enfortumab vedotin in combination with pembrolizumab in second-line urothelial cancer and MIBC has not been proven safe or effective.

EV-202 (NCT04225117) is an ongoing, multi-cohort, open-label, multicenter Phase 2 trial investigating enfortumab vedotin alone in patients with previously treated advanced solid tumors. This trial also has a cohort that is investigating enfortumab vedotin in combination with pembrolizumab in patients with previously untreated recurrent / metastatic head and neck squamous cell carcinoma.

EV-203 (NCT04995419) is a Phase 2, multicenter, single-arm bridging trial in China designed to evaluate the efficacy, safety, and pharmacokinetic performance of enfortumab vedotin as treatment for patients in China. A total of 40 patients were enrolled in the trial.

Important Safety Information
For Important Safety Information for enfortumab vedotin please see the full Summary of Product Characteristics at: View Source

On July 26, 2024 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that on July 26, 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of zolbetuximab in the European Union (Press release, Astellas, JUL 26, 2024, View Source [SID1234645105]). Zolbetuximab, a first-in-class claudin (CLDN) 18.2-targeted monoclonal antibody, is recommended in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive.1 If approved, zolbetuximab would become the first and only CLDN18.2-targeted therapy available for patients in the European Union.

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In Europe, gastric cancer is the sixth most common cause of cancer-related mortality, responsible for more than 95,000 deaths in 2022.2,3 The disease is often diagnosed in the advanced or metastatic stage due to overlapping early-stage symptoms with other more common stomach conditions.4 The average five-year survival rate for patients in Europe is 26% across all stages of the disease, driving the need for new therapeutic options that can slow progression and extend lives.5

Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Senior Vice President and Head of Immuno-Oncology Development, Astellas
"More than 135,000 new cases of gastric cancer were diagnosed in Europe in 2022, requiring new treatment options that can improve patient outcomes and address the considerable unmet needs associated with this life-limiting cancer. Zolbetuximab has the potential to become the first approved CLDN18.2 targeted treatment for patients with HER2 negative advanced gastric or GEJ cancers in the European Union, underscoring Astellas’ ongoing dedication to delivering therapeutic advancements that drive value for patients."

The positive CHMP opinion is based on the results from the Phase 3 SPOTLIGHT and GLOW clinical trials which explored the efficacy and safety of first-line zolbetuximab treatment in adult patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive, published in The Lancet and Nature Medicine respectively.6,7 CLDN18.2 positivity is defined as ≥75% of tumor cells demonstrating moderate-to-strong membranous CLDN18 immunohistochemical staining, assessed and confirmed using an in-vitro companion diagnostic test or medical device.6,7 Astellas collaborated with Roche on the VENTANA CLDN18 (43-14A) RxDx Assay that, upon approval, is intended to be used by a pathologist or laboratory to identify patients eligible for targeted treatment with zolbetuximab.8 This immunohistochemistry based companion diagnostic test is currently under review by the notified body.

The positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines in all 27 European Union (EU) member states as well as Iceland, Liechtenstein, and Norway.9

Astellas has already reflected the impact from this result in its financial forecast for the current fiscal year ending March 31, 2025.

In addition to the EMA, Astellas has submitted applications to other regulatory agencies around the world with reviews of zolbetuximab ongoing. Zolbetuximab was approved in Japan by the Ministry of Health, Labour and Welfare (MHLW) in March 2024, the first and only CLDN18.2-targeted treatment approved by any regulatory agency in the world.10 For more information, please see the press release "Astellas’ VYLOY (zolbetuximab) Approved in Japan for Treatment of Gastric Cancer" issued on March 26, 2024.

CURRENT LEGAL STATUS: Zolbetuximab has not been approved in the EU for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive.

About Zolbetuximab
Zolbetuximab is a claudin 18.2-directed cytolytic antibody being investigated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive. Eligible patients should have CLDN 18.2 positive tumor status defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining. In both the SPOTLIGHT and GLOW Phase 3 clinical trials, approximately 38% of patients screened had tumors that were CLDN18.2 positive.6,7

As an investigational first-in-class monoclonal antibody (mAb), zolbetuximab targets and binds to CLDN18.2, a transmembrane protein expressed on cancer cells. In pre-clinical studies, zolbetuximab reduced the number of CLDN18.2-positive cells via antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity, leading to tumor growth inhibition.11

About Locally Advanced Unresectable Metastatic Gastric and Gastroesophageal Junction Cancer
Across Europe, over 135,000 new cases of gastric cancer, also known as stomach cancer, were diagnosed in 2022.3 Gastric cancer is the sixth most common cause of cancer-related mortality in Europe, responsible for 95,431 deaths in 2022.2,3 Gastroesophageal junction (GEJ) adenocarcinomas start in the first two inches (5 cm) where the esophagus joins the stomach.12

Because early-stage cancer symptoms frequently overlap with more common stomach-related conditions, gastric cancers are often diagnosed in the advanced or metastatic stage, or once they have spread from the tumor’s origin to other body tissues or organs.4

Early signs and symptoms can include indigestion or heartburn, pain or discomfort in the abdomen, nausea and vomiting, bloating of the stomach after meals, loss of appetite.4,13 Signs of more advanced gastric cancer can include unexplained weight loss, weakness and fatigue, sensation of food getting stuck in the throat while eating, vomiting blood or having blood in the stool.4,13,14 Risk factors associated with gastric and GEJ cancer can include older age, male gender, family history, H. pylori infection, smoking, and gastroesophageal reflux disease (GERD).15,16

INVESTIGATIONAL STUDIES

About SPOTLIGHT Phase 3 Clinical Trial
SPOTLIGHT is a Phase 3, global, multi-center, double-blind, randomized study, assessing the efficacy and safety of zolbetuximab plus mFOLFOX6 (a combination chemotherapy regimen that includes oxaliplatin, leucovorin, and fluorouracil) compared to placebo plus mFOLFOX6 as a first-line treatment in patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive. The study enrolled 565 patients at 215 study locations in the U.S., Canada, United Kingdom, Australia, Europe, South America, and Asia. The primary endpoint is progression-free survival (PFS) of participants treated with the combination of zolbetuximab plus mFOLFOX6 compared to those treated with placebo plus mFOLFOX6. Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), safety and tolerability, and quality-of-life parameters.6

Data from the SPOTLIGHT clinical trial were presented during the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium in an oral presentation on January 19, 2023, and were subsequently published in The Lancet on April 14, 2023.6

For more information, please visit clinicaltrials.gov under Identifier NCT03504397.

About GLOW Phase 3 Clinical Trial
GLOW is a Phase 3, global, multi-center, double-blind, randomized study, assessing the efficacy and safety of zolbetuximab plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX as a first-line treatment in patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive. The study enrolled 507 patients at 166 study locations in the U.S., Canada, United Kingdom, Europe, South America, and Asia, including Japan. The primary endpoint is PFS in participants treated with the combination of zolbetuximab plus CAPOX compared to those treated with placebo plus CAPOX. Secondary endpoints include OS, ORR, DOR, safety and tolerability, and quality-of-life parameters.7

Data from the GLOW study were initially presented at the March 2023 ASCO (Free ASCO Whitepaper) Plenary Series with an updated oral presentation at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting on June 3, 2023, and were subsequently published in Nature Medicine on July 31, 2023.7

For more information, please visit clinicaltrials.gov under Identifier NCT03653507.

Investigational Pipeline in CLDN18.2
An expanded Phase 2 trial of zolbetuximab in metastatic pancreatic adenocarcinoma is in progress and recruiting patients. The trial is a randomized, multi-center, open-label study, evaluating the safety and efficacy of investigational zolbetuximab in combination with gemcitabine plus nab-paclitaxel as a first-line treatment in patients with metastatic pancreatic adenocarcinoma with CLDN18.2 positive tumors (defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18 staining based on a validated immunohistochemistry assay). For more information, please visit clinicaltrials.gov under Identifier NCT03816163.

In addition to zolbetuximab, ASP2138 is under development in our Primary Focus Immuno-Oncology area and is currently recruiting patients. ASP2138 is a bispecific monoclonal antibody that binds to CD3 and CLDN18.2, and it is currently in a Phase 1/1b study in participants with metastatic or locally advanced unresectable gastric or GEJ adenocarcinoma or metastatic pancreatic adenocarcinoma whose tumors have CLDN18.2 expression. The safety and efficacy of the agent under investigation have not been established for the uses being considered. For more information, please visit clinicaltrials.gov under Identifier NCT05365581.

There is no guarantee that the agent(s) will receive regulatory approval and become commercially available for the uses being investigated.

On July 25, 2024 Novocure (NASDAQ: NVCR) reported financial results for the quarter ended June 30, 2024 (Press release, NovoCure, JUL 25, 2024, View Source [SID1234645100]). 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).

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"The second quarter was a period of consistent execution at Novocure," said Asaf Danziger, Novocure’s Chief Executive Officer. "We began the year with three key objectives – grow our commercial business in glioblastoma, launch our next indication in non-small cell lung cancer, and deliver on the promise of our clinical and product development pipelines. I am pleased to share we have made significant progress on all fronts this quarter."

Financial updates for the second quarter ended June 30, 2024:

Total net revenues for the quarter were $150.4 million, an increase of 19% compared to the same period in 2023. This increase is primarily driven by our successful launch in France and improved U.S. approval rates.
The United States, Germany, France and Japan contributed $95.7 million, $15.1 million, $14.3 million and $7.7 million, respectively, with other active markets contributing $11.8 million.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $5.8 million.
Improved approval rates in the U.S. resulted in $5.0 million of increased net revenue from prior period claims during the quarter. In addition, we received $2.6 million in net revenues from a private payer in the United Kingdom where payments are not routine. We do not expect these two benefits, totaling $7.6 million, to recur.
Gross margin for the quarter was 77%.
Research, development and clinical studies expenses for the quarter were $55.0 million, a decrease of 1% from the same period in 2023.
Sales and marketing expenses for the quarter were $56.6 million, a decrease of 3% compared to the same period in 2023. This primarily reflects lower personnel expenses associated with support functions.
General and administrative expenses for the quarter were $37.7 million, a decrease of 8% compared to the same period in 2023. This primarily reflects lower personnel expenses.
Net loss for the quarter was $33.4 million with loss per share of $0.31.
Adjusted EBITDA* for the quarter was $1.1 million.
Cash, cash equivalents and short-term investments were $951.2 million as of June 30, 2024.
Operational updates for the second quarter ended June 30, 2024:

1,634 prescriptions were received in the quarter, an increase of 5% compared to the same period in 2023. Prescriptions from the United States, Germany, France and Japan contributed 957, 206, 176 and 108 prescriptions, respectively, with the remaining 187 prescriptions received in other active markets.
As of June 30, 2024, there were 3,963 active patients on therapy, an increase of 11% compared to the same period in 2023. Active patients from the United States, Germany, France and Japan contributed 2,175, 538, 369 and 403 active patients, respectively, with the remaining 478 active patients contributed by other active markets.
Quarterly updates and achievements:

In June, we presented positive results from the phase 3 METIS trial, evaluating the use of TTFields therapy and supportive care for the treatment of patients with brain metastases from non-small cell lung cancer (NSCLC) following stereotactic radiosurgery at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. The METIS trial met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression for adult patients treated with TTFields therapy and supportive care compared to patients treated with supportive care alone.
In June, we presented top-line results from the prospective, non-interventional TIGER study at the 2024 ASCO (Free ASCO Whitepaper) annual meeting. TIGER investigated the use of TTFields therapy in routine clinical use in the treatment of newly diagnosed GBM in Germany. The outcomes observed in the TIGER study are consistent with the survival and safety results from our phase 3 EF-14 clinical trial. TTFields therapy use was not associated with an increase in systemic toxicity and was well tolerated.
Anticipated 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 second quarter 2024 financial results at 8:00 a.m. EDT today, Thursday, July 25, 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, www.novocure.com/investor-relations, 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.