On November 21, 2023 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, reported that it will webcast its presentations at two investor conferences in November and December (Press release, Sana Biotechnology, NOV 21, 2023, View Source [SID1234637906]). The presentations will feature a business overview and update.

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!

Sana will present at the 6th Annual Evercore ISI HealthCONx Conference at 1:20 p.m. ET on Wednesday, November 29, 2023.
Sana will present at the JMP Securities Hematology and Oncology Summit at 2:00 p.m. ET on Wednesday, December 6, 2023.

The webcasts will be accessible on the Investor Relations page of Sana’s website at View Source A replay of each presentation will be available at the same location for 30 days following the corresponding conference.

On November 21, 2023 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, reported financial results for the third quarter and nine months ended September 30, 2023 (Press release, Purple Biotech, NOV 21, 2023, View Source [SID1234637905]).

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!

"We are pleased to report that we expect to complete patient enrollment in our Phase 2 randomized CM24 pancreatic cancer study soon, ahead of our previous plan and that might result in earlier than anticipated analysis of interim and top line overall survival (OS) data during 2024. The interim data look will occur in 2024 when sufficient progression free survival (PFS) and OS events are registered and enable a meaningful data interpretation for a larger number of patients. Recently reported biomarker data demonstrates CM24’s mechanism of action for this important indication in dire need of a more effective drug that prolongs survival," stated Purple Biotech CEO, Gil Efron.

"Our Phase 1/2 dose escalation study of NT219 in head and neck cancer demonstrated initial activity at the dose level of 50 mg/kg. We continue dose optimization at a higher dose level and expect to report additional data during the first half of 2024 in parallel to preparing to enter a Phase 2 study."

"With a cash runway that extends more than two years, through the second half of 2025, Purple Biotech is very well positioned to execute on multiple value-driving milestones. Moreover, we expect 2024 to be a year with major clinical data catalysts."

Q3 2023 and Recent Corporate Highlights:

● CM24 Pancreatic Cancer Program Advances

o Phase 2 enrollment ahead of schedule

o Interim results for PFS and OS expected in H1 2024 with topline results expected in H2 2024

o Biomarker data supporting MOA presented at AACR (Free AACR Whitepaper)

Patient enrollment in the Phase 2 study of CM24 was accelerated and the Company’s plan to enroll approximately 60 patients is expected to be completed soon, ahead of schedule. Since OS and PFS are event-based endpoints, a meaningful estimate of the endpoint can be achieved once sufficient events occur in the study arms. We expected this to happen in 2024 when enough PFS and OS events are registered and enable meaningful data interpretation for a larger number of patients. The acceleration allows the Company to reduce the total cost of the trial and to report, possibly earlier than expected, an interim OS analysis, the study’s primary endpoint, together with the analysis of PFS during 1H 2024. The randomized Phase 2 study (NCT04731467), in clinical collaboration with Bristol Myers Squibb (BMS), is evaluating CM24 in combination with BMS’s nivolumab plus chemotherapy in PDAC patients as a second line treatment as compared to chemotherapy alone.

New biomarker data for CM24 were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference: Pancreatic Cancer in a scientific poster titled "Phase 1 Study of CM24 in Combination with Nivolumab in Patients with Advanced Pancreatic Cancer – Survival, Exploratory Biomarkers and Effect on Neutrophil Extracellular Traps (NETs)". The study showed a high expression of CEACAM1, CM24’s target, on neutrophils and Neutrophil Extracellular Traps (NETs), and that there are enhanced levels of serum NETs in PDAC patients. This study demonstrated for the first time that CM24 treatment significantly reduced the level of NET marker in patients’ serum, suggesting CM24’s novel mechanism of action (MOA) in treating pancreatic cancer.

● NT219 Positive Phase 1/2 Interim Results in Head & Neck Cancer

o Anti-tumor activity with confirmed partial responses in highest, to date, dose cohort

o Phase 2 study is being designed

o Fortified IP protection with new patent

Initial anti-tumor activity was demonstrated at the 50mg/kg dose level of NT219 at 50mg/kg in combination with cetuximab in the Phase 1 dose escalation study. A dose-dependent increase in drug exposure of NT219 was reported and target engagement was observed in tumor samples, with 2 of the 4 evaluable recurrent and metastatic squamous cell carcinoma of the head and neck patients dosed at 50mg/kg demonstrated confirmed partial response.

A new patent was granted in China for NT219’s pharmaceutical composition. The new patent protects the method which prevents the conversion of NT219 from its active form to a less active form and supports maintenance of the active form during manufacturing, storage, and handling until administered to the patient.

Financial Results for the three Months Ended September 30, 2023

Research and Development Expenses were $4.6 million, an increase of $1.1 million, or 31.43%, compared to $3.5 million in the same period of 2022. The increase was mainly due to clinical trials expenses in our CM24 study.

Selling, General and Administrative Expenses were $1.2 million, a decrease of $0.4 million, or 25%, compared to $1.6 million in the same period of 2022. The decrease was mainly due to a decrease in share based payment expenses.

Operating Loss was $5.7 million, an increase of $0.7 million, or 14%, compared to $5.0 million in the same period of 2022. The increase was mainly due to the increase in research and development expenses.

On a non-IFRS basis (as reconciled below), adjusted operating loss was $5.3 million, an increase of $0.9 million, compared to $4.4 million in the same period of 2022.

Net Loss for the three months ended September 30, 2023 was $5 million, or $0.23 per basic and diluted ADS, compared to a net loss of $4.8 million, or $0.27 per basic and diluted ADS, in the three months ended September 30, 2022. Adjusted net loss for the three months ended September 30, 2023 was $4.6 million, an increase from $4.1 million in the three months ended September 30, 2022.

Financial Results for the Nine Months Ended September 30, 2023

Research and Development Expenses were $11.8 million, an increase of $0.3 million, or 2.6%, compared to $11.5 million in the same period of 2022. The increase was mainly due to clinical trials expenses in our CM24 study offset by lower CMC costs in 2023.

Selling, General and Administrative Expenses were $4.2 million, a decrease of $0.3 million, or 6.67%, compared to $4.5 million in the same period of 2022. The decrease was mainly due to a decrease in share base payment and insurance costs.

Operating Loss was $16 million, compared to $16 million in the same period of 2022.

On a non-IFRS basis (as reconciled below), adjusted operating loss was $14.3 million, a decrease of $0.1 million, compared to $14.4 million in the same period of 2022.

Net Loss for the nine months ended September 30, 2023 was $15.1 million, or $0.72 loss per basic and diluted ADS, compared to a net loss of $15.7 million, or $0.87 loss per basic and diluted ADS, in the same period of 2022. The decrease in net loss was mainly due to an increase of $0.6 million in finance income. Adjusted net loss for the nine months ended September 30, 2023 was $13.4 million, a decrease from $14.1 million in the nine months ended September 30, 2022.

As of September 30, 2023, the Company had $15.9 million in cash, cash equivalents and short-term deposits. In October 2023 the Company raised an additional gross amount of $5 million which extended the cash runway to the second half of 2025.

During the nine months ended September 30, 2023, the Company sold, under the Open Market Sale Agreementsm with Jefferies LLC, approximately 1,040 thousand ADSs, at a weighted average price of $1.499 per ADS. Net proceeds to the Company, were approximately $1.5 million, net of direct issuance expenses.

On November 21, 2023 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Caraway Therapeutics, Inc. reported that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Caraway Therapeutics for a total potential consideration of up to $610 million, including an undisclosed upfront payment as well as contingent milestone payments (Press release, Merck & Co, NOV 21, 2023, View Source [SID1234637904]). The upfront payment will be expensed by Merck in the fourth quarter of 2023 and included in non-GAAP results.

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!

"Caraway’s multidisciplinary approach has yielded important progress in evaluating novel mechanisms of modulation of lysosomal function with potential for the treatment of progressive neurodegenerative diseases," said George Addona, senior vice president, discovery, preclinical development and translational medicine, Merck Research Laboratories. "We look forward to applying our expertise to build upon this work with the goal of developing much needed disease-modifying therapies for these conditions."

Caraway is a preclinical biopharmaceutical company pursuing innovative approaches for the treatment of genetically defined neurodegenerative and rare diseases. The company has built a pipeline of novel, small-molecule therapeutics for the treatment of genetically defined neurodegenerative and rare diseases.

"This important milestone is a testament to the hard work and dedication of the Caraway team and our mission to develop therapeutics with the potential to alter the progression of devasting neurodegenerative diseases and help patients," said Martin D. Williams, chief executive officer, Caraway Therapeutics. "This acquisition leverages Merck’s industry-leading research and development capabilities to help further advance our discovery and preclinical programs. We thank and appreciate our investors, including SV Health Investors and its Dementia Discovery Fund, AbbVie Ventures, Amgen Ventures, Eisai Innovation and MRL Ventures Fund for their support."

Under the terms of the agreement, Merck, through a subsidiary, will acquire all outstanding shares of Caraway with earnout milestones associated with the development of certain pipeline candidates. The Board of Directors of Caraway Therapeutics has approved the transaction. Merck, through its MRL Ventures Fund, has been a shareholder of Caraway Therapeutics since 2018.

On November 21, 2023 Inventiva (Euronext Paris and Nasdaq: IVA) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of patients with non-alcoholic steatohepatitis ("NASH") and other diseases with significant unmet medical needs, reported financial information for the nine months ended September 30, 2023 (Press release, Inventiva Pharma, NOV 21, 2023, View Source [SID1234637902]).

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!

Key Financial Results

As of September 30, 2023, the Company’s cash and cash equivalents amounted to €43.8 million, short-term deposits to 0.03 million2, and long-term deposit to €5.0 million3, compared to €86.7 million, €1.0 million and €0.7 million as of December 31, 2022, respectively.

The decrease in cash and cash equivalents and short-term and long-term deposits between September 30, 2023 and December 31, 2022 is mainly due to increased cash used in operating activities and reflects the 2023 planned and continued acceleration of clinical development activities mostly driven by costs associated with the NATiV3 Phase III clinical trial of lanifibranor in NASH, and, to a lesser extent, with the LEGEND Phase IIa combination trial with lanifibranor and empagliflozin in patients with NASH and type 2 diabetes ("T2D"). This decrease is partially offset by the financing announced August 31, 20235.

Following the financing of €35.7 million (gross amount) consisting of a reserved capital increase and the issuance of royalty certificates announced by the company on August 31,20235, recorded by a decision of the Chairman and recorded by a decision of the Chairman and Chief Executive Officer on September 5, 2023 ("August Capital Increase"), and the receipt of the $10 million upfront payment from Hepalys Pharma, Inc. in October 2023, the Company believes, taking into account its current cost structure and forecast expenditure commitments, that its cash, cash equivalents and deposits should be sufficient to fund its operations until the beginning of the second quarter of 2024.

In addition, the Company expects to meet the financial conditions for the disbursement of the second tranche of €25 million of the loan granted by the European Investment Bank ("EIB") by the end of 2023 if it receives the anticipated $3 million milestone payment from Sino Biopharm, through its subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ("CTTQ"), upon the enrollment of the first patient in China in the ongoing pivotal Phase III clinical trial, NATiV3 (which is expected by the end of 2023). Considering its current cost structure and forecast expenditure commitments, the Company estimates that, including the anticipated CTTQ milestone payment and disbursement of the second tranche of €25 million of the EIB loan, the Company’s cash, cash equivalents and deposits would allow the Company to fund its operations until the beginning of the third quarter of 20244.

Net cash used in operating activities amounted to (€69.0) million in the first nine months of 2023, compared to (€40.1) million for the same period in 2022. R&D expenses for the first nine months of 2023 were up 86 % compared to the same period in 2022. This increase is in line with the clinical development activities planned in 2023.

Net cash used in investing activities for the first nine months of 2023 amounted to (€3.5) million, compared to (€0.4) million for the same period of 2022. The change is mostly due to the change in deposits between both periods.

Net cash provided by financing activities for the first nine months of 2023 amounted to €30.2 million, compared to net cash provided by financing activities of €13.1 million for the same period of 2022. The increase is mainly due to the 35.7 million (gross proceeds) of the August Capital Increase. The net cash generated in financing activities in 2022 was mainly driven by the equity raised through the Company’s at-the-market program for approximately €9.4 million (gross proceeds) in June 2022, and three loan agreements with a syndicate French banks for a total amount of €5.3 million entered into in the first half of 2022. In the first nine months of 2023, the net cash used from financing activities was mainly due to loan reimbursement and medical imaging equipment debt rents.

Over the first nine months of 2023, the Company recorded a negative exchange rate effect on cash and cash equivalents of (€0.7) million, compared to a positive effect of €2.1 million for the same period of 2022, due to the evolution of EUR/USD exchange rate.

Revenues

The Company’s revenues for the first nine months of 2023 amounted to €1.9 million, stable from the first six months of 2023, compared to €0.1 million for the same period in 2022. The increase over the 2022 period is mainly due to the receipt of the first regulatory milestone payment of $2.0 million from CTTQ in July 2023. The milestone payment was triggered in May 2023 after CTTQ received the Investigational New Drug ("IND") approval from the Chinese National Medical Products Administration ("NMPA") to initiate the clinical development in mainland China of lanifibranor in NASH.

On September 20, 2023, the Company announced that it entered into an exclusive licensing agreement with Hepalys Pharma, Inc., a company formed by Catalys Pacific, to develop and commercialize Inventiva’s proprietary drug candidate, lanifibranor, for the treatment of NASH and potentially other metabolic diseases in Japan and South Korea. Inventiva has exercised the option to acquire 30% of the shares Hepalys Pharma for the price of 300 yen. Pursuant to the terms of this licensing agreement, Inventiva received a $10 million upfront payment from Hepalys Pharma Inc. in October 2023, and will be eligible to receive up to $231 million in milestone payments if certain clinical, regulatory and commercial conditions are met. Subject to regulatory approval, Inventiva will additionally have the right to receive tiered royalties from mid double digits to low twenties based on net sales of lanifibranor in Japan and South Korea, if approved. Under IFRS 15, the above upfront milestone is expected to be recorded in Q4 2023, after the know-how and IP transfer in progress are fully completed.

On November 21, 2023 Exelixis, Inc. (Nasdaq: EXEL) reported that company management will participate in a fireside chat at the Piper Sandler 35th Annual Healthcare Conference on Tuesday, November 28 at 11:00 am ET / 8:00 am PT (Press release, Exelixis, NOV 21, 2023, View Source [SID1234637901]).

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!

To access the webcast link, log onto www.exelixis.com and proceed to the Event Calendar page under the Investors & News heading. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcasts. A replay will also be available at the same location for at least 30 days.