Mirati Therapeutics Provides Update on the Phase 3 SAPPHIRE Study Evaluating Sitravatinib in Combination with OPDIVO

On May 24, 2023 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a commercial-stage oncology company, reported that the SAPPHIRE study did not meet its primary endpoint of overall survival at the final analysis (Press release, Mirati, MAY 24, 2023, View Source [SID1234631998]). SAPPHIRE is a Phase 3 study evaluating sitravatinib in combination with nivolumab (OPDIVO)1 versus docetaxel in patients with second or third line advanced non-squamous non-small cell lung cancer (NSQ-NSCLC) who progressed on prior therapy with chemotherapy and immune checkpoint inhibitor therapy. The company plans to disclose the study data at a future date.

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Principal Investigators will be given the option to continue therapy for patients who are experiencing clinical benefit and would like to remain on treatment.

"Mirati extends gratitude to the patients who participated in this clinical trial, their loved ones, and the trial investigators, without whom important work like this would not have been possible," said Alan Sandler, M.D., Chief Medical Officer. "As we move forward, we are optimistic about our ability to positively impact the lives of patients living with cancer through the advancement of our broad and differentiated pipeline of targeted oncology programs."

Mersana Therapeutics to Present at Upcoming Investor Conferences

On May 24, 2023 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that members of management will present at the following upcoming investor conferences (Press release, Mersana Therapeutics, MAY 24, 2023, View Source [SID1234631996]):

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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

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TD Cowen 4th Annual Oncology Innovation Summit

Format: Fireside Chat
Date/Time: Wednesday, May 31, 2023, at 10:00 a.m. Eastern Time
Jefferies Healthcare Conference

Format: Presentation
Date/Time: Wednesday, June 7, 2023, at 9:00 a.m. Eastern Time
Live webcasts of these events will be available on the Investors & Media section of Mersana’s website at www.mersana.com. Archived replays will be available for approximately 90 days following the events.

Exscientia Business Update for First Quarter 2023

On May 24, 2023 Exscientia plc (Nasdaq: EXAI) reported recent advancements in the Company’s pipeline, collaborations and operations, as well as financial results for the first quarter 2023, are summarised below (Press release, Exscientia, MAY 24, 2023, View Source [SID1234631994]). Exscientia will host a conference call Wednesday, May 24 at 1:30 p.m. BST / 8:30 a.m. EDT.

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"With our sixth AI-designed compound reaching the clinical development stage plus two more in active IND/CTA-enabling studies, Exscientia’s pipeline of wholly owned and partnered drug candidates is progressing rapidly," said Professor Andrew Hopkins FRS FMedSci, founder and Chief Executive Officer of Exscientia. "Most recently, the first patient has been dosed in our IGNITE Phase 1/2 clinical trial. While many people are familiar with Exscientia’s industry leading drug design capabilities, we also continue to clinically validate our novel, AI-enabled biomarker strategy to ensure that the right patients can benefit from precision medicines in the future."

Recent Highlights
Internal pipeline
●In May 2023, the first patient was dosed in the Phase 1/2 IGNITE clinical trial of EXS21546 (‘546), Exscientia’s A2AR antagonist, for the treatment of relapsed/refractory renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC)
●In April 2023, Exscientia presented four posters at the AACR (Free AACR Whitepaper) Annual Meeting highlighting Exscientia’s ability to precision design molecules coupled with the development of multi-gene signatures. The clinical and preclinical data highlighted two programmes, ‘546 and EXS74539 (‘539)
●In March 2023, Exscientia announced two new wholly-owned precision designed molecules, ‘539, an LSD1 inhibitor, and EXS73565 (‘565), a MALT1 inhibitor
○‘539 and ‘565 continue to progress through IND/CTA-enabling studies and Exscientia expects to provide an update on clinical development plans in the second half of 2023
○Company remains on track to meet target of four candidates in clinical development by 2024 (not including Sumitomo Pharma programmes)

Partnered programmes
●In May 2023, Exscientia announced that DSP-2342, the third compound from the collaboration with Sumitomo Pharma, will enter Phase 1 clinical trials. It is the third molecule created utilising Exscientia’s AI-driven drug discovery platform under a design-as-a-service (DaaS) collaboration with Sumitomo Pharma. The collaboration is now complete and Exscientia retains no economics
●In February 2023, Exscientia announced the initiation of a first-in-human study of EXS4318 (‘4318), the first immunology & inflammation candidate designed by Exscientia and in-licensed by Bristol Myers Squibb
○The potentially first-in-class potent and selective PKC-theta inhibitor is currently in Phase 1 clinical trials in the United States

Collaboration with Charité
●In March 2023, Exscientia announced a collaboration with leading European medical centre Universitätsmedizin Berlin (Charité) to further validate Exscientia’s precision medicine platform to predict response in haematological cancers
●Charité will also establish a biobank of viably cryopreserved blood, bone marrow and lymph node tissues to support further technology development and preclinical research projects at both Exscientia and Charité

AI and automation highlighted at SLAS 2023
●In May 2023, Exscientia announced the presentation of an oral and poster presentation and the closing keynote for the Society for Laboratory Automation and Screening (SLAS) Europe Conference and Exhibition held in Brussels, Belgium taking place from May 22-May 25. The presentations highlight Exscientia’s leadership in AI-enabled drug discovery, including advancements in automation

Investor Call and Webcast Information
Exscientia will host a conference call on Wednesday, May 24 at 1:30 p.m. BST / 8:30 a.m. ET.
A webcast of the live call can be accessed by visiting the "Investors and Media" section of the Company’s website at investors.exscientia.ai. Alternatively, the live conference call can be accessed by dialling +1 (888) 330 3292 (U.S.), +44 203 433 3846 (U.K.), +1 (646) 960 0857 (International) and entering the conference ID: 8333895. A replay will be available for 90 days under "Events and Presentations" in the "Investors and Media" section of the Exscientia website.

First Quarter 2023 Financial Results
For the convenience of the reader, the Company has translated pound sterling amounts to U.S. dollars at the rate of £1.000 to $1.2369, which was the noon buying rate of the Federal Reserve Bank of New York on March 31, 2023.

Revenue: Revenue for the first quarter 2023 was $7.1 million, compared to $8.6 million for the three months ended March 31, 2022.

Research and development expenses: R&D expenses for the three months ended March 31, 2023 were $41.3 million, as compared to $28.9 million for the three months ended March 31, 2022. The increase in research and development expenses was in part due to the growth of our internal and co-owned portfolio, increased headcount and increased depreciation charges arising from continued investment into laboratory equipment.

General and administrative expenses: G&A expenses for the three months ended March 31, 2023, were $13.5 million, or 20.7% of total operating expenses. For the first quarter 2023, G&A expenses increased by $3.8 million compared to the first quarter 2022, primarily associated with an increase in personnel costs associated with growth in headcount.

Cash inflows: For the first quarter 2023, Exscientia received $0.5 million in cash inflows from its collaborations as compared to $6.3 million during the first quarter 2022.

Net operating cash flow and cash balance: For the three months ended March 31, 2023, net operating cash outflows were $53.7 million, in comparison to net operating cash outflows of $19.4 million for the three months ended March 31, 2022, reflecting increased research and development spend as well as working capital outflows. Cash, cash equivalents and short term bank deposits as of March 31, 2023 were $553.3 million, as compared to $625.6 million as of December 31, 2022 using the March 31, 2023 constant currency rate.
●Includes constant currency mark-to-market foreign exchange impact of -2% based on the strengthening of pounds sterling through March 31, 2023
●During the first quarter of 2023, Exscientia recognised net foreign exchange losses of $1.5 million
●The Company holds its deposits in both GBP and USD, intended to match expected operational cash needs in order to limit the impact of exchange rate fluctuations

BioLineRx Reports First Quarter 2023 Financial Results and Recent Corporate and Portfolio Updates

On May 24, 2023 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, reported its unaudited financial results for the first quarter ended March 31, 2023, and provided corporate and portfolio updates (Press release, BioLineRx, MAY 24, 2023, View Source [SID1234631992]).

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"This has been an exciting quarter for the Company as we prepare for the potential approval and U.S. commercial launch of motixafortide in September of this year," said Philip Serlin, Chief Executive Officer of BioLineRx. "Last month’s publication in Nature Medicine of our GENESIS Phase 3 clinical trial data suggest motixafortide’s potential to address critical challenges and evolving needs in the autologous stem cell transplant setting in appropriate multiple myeloma patients, and in preparation for an aggressive launch, our U.S. operation continues its commercialization-readiness activities. We recently completed hiring an experienced sales force, and have substantially advanced supply chain, market access and medical affairs activities. Additionally, the Company, along with our collaboration partners, continues to make clinical development progress evaluating motixafortide in pancreatic cancer (PDAC) and in SCM for gene therapies. We anticipate PDAC clinical data later this year, as well as the initiation of new clinical trials for both PDAC and SCM in gene therapy. We believe each of these areas can support long-term growth."

Corporate Updates

On track for September 9, 2023 PDUFA target action date
Hired targeted sales force with expertise in high opportunity transplant centers, in preparation for potential September launch
Portfolio Execution

Motixafortide (selective inhibitor of CXCR4 chemokine receptor)

Multiple Myeloma

Announced publication in Nature Medicine of GENESIS Phase 3 clinical trial data evaluating motixafortide and G-CSF in stem cell mobilization for autologous transplantation in multiple myeloma
Pancreatic Ductal Adenocarcinoma

Continued to advance preparation activities for a Phase 2b randomized clinical trial with 200 patients assessing motixafortide in combination with a PD-1 inhibitor and standard-of-care chemotherapy as a first-line metastatic PDAC (mPDAC) therapy with collaboration partner GenFleet. Anticipate clinical trial initiation in 2023
Continued collaboration progress with Columbia University investigator-initiated Phase 2 study assessing motixafortide in combination with the PD-1 inhibitor cemiplimab and standard-of-care chemotherapy as first-line treatment in patients with mPDAC. Anticipate initial patient data in 2023
Sickle Cell Disease & Gene Therapy

Announced clinical trial collaboration with Washington University School of Medicine in St. Louis to evaluate motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell mobilization for gene therapies in sickle cell disease. Anticipate clinical trial initiation in 2023
AGI-134 (synthetic alpha-Gal glycolipid)

Solid Tumor Immunotherapy

Evaluating next development pathways for AGI-134 program in consultation with scientific advisory board. Results from Phase 1/2a first-in-human, single-agent study announced in Q4 2022. Study met primary endpoint for safety and tolerability and demonstrated immune activity across multiple biomarkers
First Quarter 2023 Financial Results

Research and development expenses for the three months ended March 31, 2023 were $3.7 million, a decrease of $0.7 million, or 16.9%, compared to $4.4 million for the three months ended March 31, 2022. The decrease resulted primarily from lower expenses related to NDA supporting activities for motixafortide, as well as lower expenses associated with the completed AGI-134 clinical trial.
Sales and marketing expenses for the three months ended March 31, 2023 were $3.9 million, an increase of $3.2 million, or 508%, compared to $0.6 million for the three months ended March 31, 2022. The increase resulted primarily from the ramp-up of pre-commercialization activities related to motixafortide.
General and administrative expenses for the three months ended March 31, 2023 were $1.3 million, an increase of $0.3 million, or 28.9%, compared to $1.0 million for the three months ended March 31, 2022. The increase resulted primarily from an increase in payroll and related expenses due to a small increase in headcount and share-based compensation, as well as small increases in a number of G&A expenses.
As of March 31, 2023, the Company held cash, cash equivalents, and short-term bank deposits of $43.3 million and anticipates this will be sufficient to fund operations, as currently planned, into the first half of 2024.
Conference Call and Webcast Information

To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until May 26, 2023; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

BeiGene to Present at Upcoming Investor Conferences

On May 24, 2023 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, reported that the Company will participate in fireside chats at two upcoming investor conferences (Press release, BeiGene, MAY 24, 2023, View Source [SID1234631991]):

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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

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TD Cowen 4th Annual Oncology Innovation Summit on Wednesday, May 31st at 12:00 pm ET; and
Goldman Sachs 44th Annual Global Healthcare Conference on Monday, June 12th at 11:40 am ET

Live webcasts of these events can be accessed from the investors section of BeiGene’s website at View Source and archived replays will be available for 90 days following the events.