On November 18, 2021 Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences, Inc. (NYSE: RCUS) reported that Gilead has exercised its options to three programs in Arcus’s clinical-stage portfolio, including both anti-TIGIT molecules, domvanalimab and AB308, as well as etrumadenant and quemliclustat (Press release, Gilead Sciences, NOV 18, 2021, View Source [SID1234595797]). The companies also added a research collaboration as described below. Today’s transaction is subject to applicable antitrust clearance under the Hart-Scott Rodino Antitrust Improvements Act and other customary closing conditions. The parties expect the transaction to close by year-end.

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Domvanalimab is an Fc-silent anti-TIGIT antibody in Phase 2 and Phase 3 studies in non-small cell lung cancer (NSCLC) and AB308 is an Fc-enabled anti-TIGIT antibody under Phase 1 evaluation. Etrumadenant is a dual adenosine A2a/A2b receptor antagonist in Phase 1 and Phase 2 studies in NSCLC, colon cancer and prostate cancer. Quemliclustat is a small molecule CD73 inhibitor in a Phase 1 study in metastatic pancreatic ductal adenocarcinoma (PDAC).

Gilead has been encouraged by early clinical data generated for each of the three programs. By opting in early to all three programs now, Gilead and Arcus are able to accelerate the clinical development and advancement of these clinical-stage molecules and facilitate the exploration of treatment combinations across the portfolios. For example, Gilead will be able to pursue potential chemotherapy-free regimens with Trodelvy (sacituzumab govitecan-hziy) in combination with therapies optioned from the Arcus portfolio. Gilead will also have the flexibility to add Gilead portfolio candidates to existing Arcus studies.

"Gilead is pursuing some of the most promising mechanisms of action in oncology today, with the aim of achieving better treatment outcomes for more patients," said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. "The addition of three mid- to late-stage clinical programs into our oncology pipeline significantly expands the number of transformational medicines we can potentially deliver to people with cancer, while also enabling our pursuit of novel combinations."

"Through the expanded partnership, we will be able to leverage the combined portfolios of the two companies to enable rational exploration of unique and innovative combination therapies within a single integrated program," said Terry Rosen, Ph.D., Chief Executive Officer of Arcus. "The early exercise of Gilead’s options will now ensure that Arcus is well positioned to accelerate and expand clinical development activities so that it may deliver benefit to patients with some of the most difficult to treat cancers, including pancreatic, lung, colon and prostate."

Terms of the Exercised Options and Amendment to the Agreement

Under the terms of the parties’ Option, License and Collaboration Agreement (the "2020 Agreement"), for the three options that Gilead is exercising today, Arcus will receive option payments totaling $725 million. The parties will co-develop and share the global costs related to these programs. If the optioned molecules achieve regulatory approval, Gilead and Arcus will co-commercialize and equally share profits in the U.S. Gilead will hold exclusive rights outside the U.S., subject to any rights of Arcus’s existing collaboration partners, and Gilead will pay to Arcus tiered royalties.

With Gilead’s early option exercises for all three programs, Gilead and Arcus amended the 2020 Agreement, including as follows:

Arcus may be required to operationalize at least 50% of the clinical studies, with costs to be shared by Gilead and Arcus.
The royalties payable by Gilead to Arcus on sales for these three programs outside of the U.S. were slightly reduced. The reduced royalties range from the mid-teens to the low twenties.
Arcus will lead the discovery and early development of drug candidates against two novel research targets jointly selected by the parties.
Upon closing of the transaction for all three programs, the $100 million option continuation payment due in 2022 will not be made by Gilead.
Summary of anti-TIGIT Program

ARC-7 is a Phase 2 study evaluating patients randomly allocated to domvanalimab plus zimberelimab vs. zimberelimab alone vs. domvanalimab plus zimberelimab plus etrumadenant as first-line treatment for PD-L1 ≥ 50%, metastatic NSCLC. The study is actively enrolling with a target total enrollment of 150 patients who are being randomly allocated 1:1:1 to each group and treated until disease progression or loss of clinical benefit. Gilead and Arcus have jointly decided that results, including data on progression-free survival, will be presented at a medical conference in 2022.
ARC-10 is an ongoing registrational Phase 3 study intended to support the potential approvals of both zimberelimab monotherapy and domvanalimab plus zimberelimab in first-line, locally advanced or metastatic PD-L1≥50% NSCLC.
PACIFIC-8 is a registrational Phase 3 study with a planned initiation by the end of 2021 in collaboration with AstraZeneca. PACIFIC-8 will evaluate domvanalimab plus durvalumab, an anti-PD-L1 antibody, with curative intent in unresectable Stage 3 NSCLC, where durvalumab is standard of care.
ARC-12 is a Phase 1 study evaluating AB308 plus zimberelimab in advanced malignancies with five expansion cohorts currently open for enrollment.
Summary of ATP-Adenosine Axis (CD73 and A2a/A2b Receptor) Programs

ARC-4 is a randomized Phase 1 study evaluating etrumadenant plus zimberelimab and chemotherapy vs. zimberelimab plus chemotherapy in EGFRmut tyrosine kinase inhibitor (TKI)-relapsed and refractory NSCLC. Initial data are expected to be presented in 1H22.
ARC-6 is a Phase 1b/2 platform study in metastatic castration-resistant prostate cancer with a randomized cohort evaluating docetaxel versus docetaxel plus etrumadenant and zimberelimab. Initial results are expected in 2022.
ARC-7 is an open-label randomized Phase 2 study as noted above.
ARC-8 is an ongoing Phase 1 study evaluating quemliclustat plus zimberelimab and gemcitabine/nab-paclitaxel in first-line pancreatic cancer, with a randomized cohort comparing against quemliclustat plus gemcitabine/nab-paclitaxel. Gilead and Arcus have jointly decided that results, including data on progression-free survival, will be presented at a medical conference in 2022.
ARC-9 is a randomized Phase 1b/2, open-label, multi-center platform study to evaluate the efficacy of etrumadenant in combination with zimberelimab and FOLFOX with or without bevacizumab in second- and third-line metastatic colorectal cancer.
Additional clinical studies are expected to be initiated in 2022.
Zimberelimab, domvanalimab, AB308, etrumadenant and quemliclustat are investigational agents and have not been proven safe and efficacious. Durvalumab, docetaxel, gemcitabine/nab-paclitaxel, FOLFOX and bevacizumab are owned by companies other than Arcus and Gilead.

About the Gilead Collaboration

In May 2020, Gilead and Arcus entered into a 10-year collaboration that provided Gilead immediate rights to zimberelimab and the right to opt into all other Arcus programs arising during the collaboration term. In November 2021, Gilead and Arcus amended the collaboration in connection with Gilead’s option exercise for three of Arcus’s then-clinical stage programs. For all other programs that are in clinical development or new programs that enter clinical development thereafter, the opt-in payments are $150 million per program. Gilead’s option, on a program-by-program basis, expires after a specified period of time following the achievement of a development milestone for such program and Arcus’s delivery to Gilead of the requisite qualifying data package. Concurrent with the May 2020 collaboration agreement, Gilead and Arcus entered into a stock purchase agreement under which Gilead made a $200 million equity investment in Arcus. That stock purchase agreement was amended and restated in February 2021 in connection with Gilead’s increased equity stake in Arcus from 13% to 19.7%, with an additional $220 million investment.

Upon closing of Gilead’s exercise of its option to a program, the two companies will co-develop and share global development costs for the joint development program, subject to certain opt-out rights of Arcus in some cases and expense caps on its spending and related subsequent adjustments. For each optioned program, provided that Arcus has not exercised its opt-out rights, if any, Arcus has an option to co-promote in the United States with equal profit share. Gilead has the right to exclusively commercialize any optioned programs outside of the U.S., subject to the rights of Arcus’s existing collaboration partners to any territories, and, for clinical stage programs that Gilead has opted into, Gilead will pay Arcus tiered royalties as a percentage of revenues ranging from the mid or high teens to the low twenties.

On November 18, 2021 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new approaches for the treatment for cancer and fibrosis, reported it has completed its review of all primary, secondary and exploratory endpoints in its successful Phase 1 clinical trial of AMP945 (Press release, Amplia Therapeutics, NOV 18, 2021, View Source;[email protected] [SID1234595796]). The results confirm that, in the trial, AMP945 was safe and well tolerated at all doses tested, exhibited excellent pharmacokinetic properties and was able to engage with its intended target, Focal Adhesion Kinase (FAK). Further details about the trial and its results are provided below.

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About the Phase 1 Trial

The clinical trial, designated as AMP945-101 and entitled "A Phase I, randomised, double blind, placebo-controlled study of the safety, tolerability and pharmacokinetics of single and repeat doses of AMP945 administered orally to healthy adult volunteers", was conducted at Nucleus Network in Melbourne. The study was conducted under a protocol approved by the Alfred Hospital Human Research Ethics Committee (HREC) in September 2020.

The Primary Endpoints for the trial were focused on the safety and tolerability of orally administered AMP945 which were assessed by evaluating the nature, incidence and severity of adverse events, withdrawals, physical examinations, vital signs, ECGs and safety laboratory test results including assessment of biochemical and haematological markers. Secondary endpoints assessed the pharmacokinetics of AMP945. An exploratory endpoint assessed the ability of AMP945 to target FAK in skin punch biopsies.

Overall, the trial recruited 56 healthy volunteers who were dosed with either single or multiple doses of AMP945 or placebo. Single and multiple doses of AMP945 up to 125mg and 100mg respectively, were given. Multiple doses were taken once daily for seven days. To study the effect of food on absorption of AMP945, one cohort of participants was given AMP945 both before and after food. Participants in the trial ranged in age from 18-65.

Safety and Tolerability
AMP945 was well tolerated at all doses given and there were no withdrawals or serious adverse events recorded in the trial. Adverse events were generally mild or moderate and were distributed evenly across participants assigned to AMP945 or placebo. Mild headache was the most frequently observed adverse event and the majority of safety findings were considered as either not related or unlikely to be related to AMP945. Events that were considered ‘possibly’ related to AMP945 included one incidence of diarrhoea, two incidences of headache, one taste disorder and one hot flush. There were no clinically significant changes in vital signs, clinical or laboratory parameters associated with AMP945. No adverse safety signals or dose-related trends were detected in any of the parameters measured.

Pharmacokinetics
AMP945 was delivered via capsules, taken with a glass of water. Following oral dosing, the plasma half-life of AMP945 was approximately 20 hours indicating that AMP945 was both orally bioavailable and could be administered once daily. Plasma levels of AMP945 exceeded the concentrations required to inhibit the intended target (FAK) with maximum plasma levels (Cmax) being achieved after approximately 2-4 hours post dose. Exposure parameters, including Cmax and area under the curve (AUC), all increased in a dose-dependent manner. There was no evidence of any food effect on the absorption of AMP945. Studies are ongoing to measure the inhibitory activity of AMP945 on FAK in skin punch biopsies and to assess the plasma metabolite profiles of AMP945.

Pharmacodynamics
As part of the trial, skin biopsies were collected from participating healthy volunteers to evaluate the ability of AMP945 to inhibit FAK in human tissues. Analysis of these samples required Amplia to develop a sensitive assay that allowed the measurement of the active form of FAK (phospho-FAK or pFAK) in skin samples before and after AMP945 was administered. Samples collected from 24 volunteers have now been analysed and demonstrate that oral administration of AMP945 results in a decrease in active pFAK and the extent of the inhibition of FAK activity correlates with drug levels of AMP945.

In addition to demonstrating the dose-dependent reduction in pFAK in healthy volunteers, these results verify the utility of the assay used to measure pFAK in human tissue samples, confirming the availability of a test method which can be used to guide dose selection in the Company’s planned Phase 2 clinical trials of AMP945.

Amplia’s CEO and Managing Director, Dr John Lambert, commented that "Putting all the elements of this trial together, we are now able to declare it as a resounding success. Not only have we found that AMP945 has excellent pharmaceutical properties and appears to be suitable for once-daily oral dosing, we also know that it has a suitable safety profile for further development and, moreover, hits the intended target. Taking all this information together reinforces our confidence that we are on a solid foundation for Phase 2 trials of AMP945 in patients with pancreatic cancer and pulmonary fibrosis"

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics

On November 18, 2021 Nuvo Pharmaceuticals Inc. (TSX:MRV; OTCQX:MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), a Canadian focused healthcare company with global reach and a diversified portfolio of commercial products, reported it will host an investor presentation webcast on Thursday, December 2, 2021 at 2:00 p.m. ET (11:00 a.m. PT) (Press release, Nuvo Pharmaceuticals, NOV 18, 2021, View Source [SID1234595794]).

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During the webcast, Jesse Ledger, President & Chief Executive Officer and Mary-Jane Burkett, Vice President & Chief Financial Officer of Miravo will provide a PowerPoint presentation that will cover key areas of Miravo’s business. During the presentation, investors will have an opportunity to ask questions through an interactive Q&A portal.

To access the webcast or to ask questions during the live event, please pre-register at the following link: View Source;tp_key=8127b0e5a0.

An archived version of the webcast and presentation will be available on the Presentations & Webcasts page of the Company’s website, View Source following the event.

On November 18, 2021 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported its financial results for the quarter ended September 30, 2021 and provides a corporate update (Press release, BioLineRx, NOV 18, 2021, View Source [SID1234595792]).

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Significant events and achievements during the third quarter 2021 and subsequent period:

Announced statistically significant positive results from a pharmacoeconomic cost effectiveness study supporting Motixafortide’s use as the new standard-of-care and primary mobilization agent (in combination with G-CSF) in stem cell mobilization (SCM). The study demonstrated substantial clinical benefits and cost savings in favor of Motixafortide from a significantly higher number of mobilized cells, reduced numbers of apheresis sessions and reduced doses of G-CSF;
Announced acceptance of an oral presentation, as well as three poster presentations, at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, which is taking place December 11-14. The presentations, which include an oral presentation describing the highly significant and clinically meaningful results from the Company’s GENESIS Phase 3 clinical trial in stem cell mobilization (SCM), reflect the versatility of Motixafortide as the backbone of promising new treatments for both hematological and solid tumor cancers;
Finalized preparations for a pre-NDA meeting with FDA, which is set for mid-December;
Proceeded with activities in support of a New Drug Application (NDA) submission in stem cell mobilization planned for the first half of 2022;
Ended the third quarter on a solid financial footing, with cash and cash equivalents of $62.2 million.
"The key highlight since our last quarterly update was the statistically significant positive results from a pharmacoeconomic study of Motixafortide in stem cell mobilization for multiple myeloma patients," stated Philip Serlin, Chief Executive Officer of BioLineRx. "The study demonstrated that use of Motixafortide on top of G-CSF resulted in a net cost savings of $17,000 per patient, not including the cost of Motixafortide, driven by fewer doses of G-CSF and a reduction in the number of apheresis sessions and related costs, versus G-CSF alone. These cost savings should leave substantial room in the future to optimize our pricing strategy for Motixafortide at product launch and thereafter, if approved.

"These results, together with the overwhelmingly positive results from our GENESIS Phase 3 study, which showed that almost 90% of patients collected an optimal number of cells for transplantation following a single administration of Motixafortide and in only one apheresis session, strongly support our view that Motixafortide, in combination with G-CSF, can become the new standard of care in SCM as an upfront, or primary, therapy for all multiple myeloma patients. If approved, this represents a significant advancement in SCM to the benefit of patients and payers alike and, to that end, we plan to submit an NDA to the FDA in the first half of next year.

"Our significant progress in SCM, together with the encouraging results we have seen in trials to date in metastatic pancreatic cancer, reflect the versatility of Motixafortide in both hematological and solid tumor cancers, which we have an opportunity to highlight at this year’s ASH (Free ASH Whitepaper) meeting next month. Our notable presence at such an important medical conference reflects the excellent progress that we have made to date across these core programs and underscores the momentum that we have entering 2022.

"With over $62 million in cash, we believe we are well financed to achieve our upcoming important and potentially value creating milestones," Mr. Serlin concluded.

Upcoming Expected Milestones:

Complete pre-NDA meeting with the FDA for SCM, scheduled for mid-December 2021;
Complete recruitment of part 2 of ongoing Phase 1/2a trial of AGI-134 in solid tumors by end of 2021;
Announce initial results for Part 2 of Phase 1/2a trial of AGI-134 in solid tumors in first half of 2022;
Submit NDA for Motixafortide in SCM in first half of 2022.
Financial Results for the Quarter Ended September 30, 2021

Research and development expenses for the three months ended September 30, 2021 were $4.9 million, an increase of $1.4 million, or 41.3%, compared to $3.5 million for the three months ended September 30, 2020. The increase resulted primarily from an increase in expenses associated with the AGI-134 study and a timing difference related to a tax credit received in respect of AGI-134, as well as an increase in payroll and related-expenses due to a company-wide salary reduction related to the COVID-19 pandemic in the comparable 2020 period. Research and development expenses for the nine months ended September 30, 2021 were $14.3 million, an increase of $0.8 million, or 5.9%, compared to $13.5 million for the nine months ended September 30, 2020. The increase resulted primarily from an increase in expenses associated with the AGI-134 study, as well as an increase in payroll and related-expenses due to a company-wide salary reduction related to the COVID-19 pandemic in the comparable 2020 period, offset by lower expenses associated with the completed Motixafortide GENESIS and COMBAT clinical trials.

Sales and marketing expenses for the three months ended September 30, 2021 were $0.2 million, a decrease of $0.1 million, or 20.1%, compared to $0.3 million for the three months ended September 30, 2020. The decrease resulted primarily from lower consultancy services related to Motixafortide. Sales and marketing expenses for the nine months ended September 30, 2021 were $0.7 million, similar to the comparable period in 2020.

General and administrative expenses for the three months ended September 30, 2021 were $1.1 million, an increase of $0.2 million, or 22.3%, compared to $0.9 million for the three months ended September 30, 2020. The increase resulted primarily from an increase in directors’ and officers’ insurance. General and administrative expenses for the nine months ended September 30, 2021 were $3.1 million, an increase of $0.3 million, or 9.3%, compared to $2.8 million for the nine months ended September 30, 2020. The reason for the increase is similar to the aforementioned increase in the three-month period.

The Company’s operating loss for the three months ended September 30, 2021 amounted to $6.2 million, compared to an operating loss of $4.6 million for the quarter ended September 30, 2020. The Company’s operating loss for the nine months ended September 30, 2021 was $18.2 million, compared to $17.1 million for the comparable period in 2020.

Non-operating income (expenses) for the three and nine months ended September 30, 2021 primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet and issuance expenses of the ATM. Non-operating income (expenses) for the three and nine months ended September 30, 2020 primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet, offset by warrant offering expenses and issuance expenses of the ATM.

Net financial expenses for the three months ended September 30, 2021 amounted to $0.2 million compared to net financial expenses of $0.3 million for the three months ended September 30, 2020. Net financial expenses for the nine months ended September 30, 2021 amounted to $0.5 million compared to net financial expenses of $0.9 million for the nine months ended September 30, 2020. Net financial expenses for all periods primarily relate to interest paid on loans, offset by investment income earned on bank deposits.

The Company’s net loss for the three months ended September 30, 2021 amounted to $5.7 million, compared with a net loss of $4.6 million for the comparable period in 2020. The Company’s net loss for the nine months ended September 30, 2021 amounted to $22.8 million, compared with a net loss of $18.0 million for the comparable period in 2020.

The Company held $62.2 million in cash, cash equivalents and short-term bank deposits as of September 30, 2021.

Net cash used in operating activities was $18.1 million for the nine months ended September 30, 2021, compared with net cash used in operating activities of $17.8 million for the nine months ended September 30, 2020. The $0.3 million increase in net cash used in operating activities in 2021 was primarily the result of an increase in research and development expenses.

Net cash used in investing activities was $42.2 million for the nine months ended September 30, 2021, compared to net cash provided by investing activities of $8.1 million for the nine months ended September 30, 2020. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits.

Net cash provided by financing activities was $57.6 million for the nine months ended September 30, 2021, compared to net cash provided by financing activities of $10.9 million for the nine months ended September 30, 2020. The cash flows in 2021 primarily reflect the underwritten public offering of our ADSs in January 2021, warrant exercises, and net proceeds from the ATM facility, offset by repayments of the loan from Kreos Capital. The cash flows in 2020 primarily reflect two registered direct offerings to institutional investors, net proceeds from the ATM facility, offset by repayments of the loan from Kreos Capital.

Conference Call and Webcast Information

BioLineRx will hold a conference call today, Thursday, November 18, 2021, at 10:00 a.m. EST. To access the conference call, please dial +1-866-744-5399 from the US or +972-3-918-0644 internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx’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.

A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until November 21, 2021; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

On November 18, 2021 Exact Therapeutics AS ("EXACT-Tx", or "the Company" Euronext Growth: EXTX), a clinical-stage precision health company evaluating Acoustic Cluster Therapy (ACT) across multiple therapeutic areas, reported a number of strategic, operational and scientific developments (Press release, Exact Therapeutics, NOV 18, 2021, View Source [SID1234595791]).

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As reported in May 2021, EXACT-Tx plans to file a protocol amendment regarding its ACTIVATE phase 1 clinical trial with the UK MHRA. Following approval, the Company plans to recommence enrolment in the trial at the Royal Marsden Hospital London / Institute of Cancer Research with the recruitment of patients in the part 1 cohort planned to be completed by mid 2022. The study aims to evaluate the combination of PS101 ACT with standard of care chemotherapy for treatment of liver metastases in patients with metastatic colorectal cancer A number of valuable and encouraging insights have been gained from this first cohort of treated patients particularly with respect to the application of ultrasound.

The Company also announces that it aims to start its first clinical trial in the USA to evaluate ACT in pancreatic cancer patients. In the USA there are approximately 60,000 newly diagnosed cases of pancreatic cancer and approx. 50,000 deaths per year. The Company expects to submit IND filing to the FDA by mid 2022 which, if approved, will be followed by the start of the clinical trial towards the end of 2022. Today, the 18th of November, is Pancreatic Cancer Awareness Day, and EXACT-Tx is committed to play its role in fighting this aggressive disease.

EXACT-Tx is pleased to announce that Co-Founder Dr Andrew ("Andy") Healey has returned to the Company as Chief Scientific Officer. Andy brings over 20 years experience in the life sciences industry, primarily working with contrast agents and optical molecular imaging, physics, instrumentation, characterisation and clinical imaging systems & trials. The Company’s management team has been significantly strengthened this year with the appointments of Dr Hilary McElwaine-Johnn as Chief Medical Officer and Dominic Moreland as Chief Financial Officer and subsequently Interim Chief Executive Officer.

Strong preclinical data on ACT were recently published in The Journal of Controlled Release 1 which demonstrated that ACT safely and temporarily increased the permeability of the Blood Brain Barrier ("BBB") in animal models as well as increased the penetration and accumulation of co-administered compounds including nanoparticles with no treatment related tissue damage observed. The BBB remains a formidable challenge to the delivery of drugs into the brain. The published preclinical data demonstrates that ACT could be a potential strategy to overcome this obstacle and promote efficient and specific crossing through BBB of therapeutically relevant agents, addressing a huge unmet medical need and further demonstrating the power of the ACT platform. "We have demonstrated that ACT has the ability to open the BBB in a pre-clinical model to deliver large molecules and nano particles with no observable damage to the brain. This approach is an exciting and evolving field that has the promise to deliver drug and to treat the central nervous system." says Professor Catharina de Lange Davies, Dept. of Physics, Norwegian University of Science and Technology (NTNU), and co-author of the paper.

Dr Masha Strømme, Executive Chair of the Board, stated: "We have significantly strengthened our team over the last few months and are well positioned to maximise the value of our innovative Acoustic Cluster Therapy (ACT) platform for ultrasound enhanced drug targeting which has the potential to significantly amplify the clinical utility of a wide range of therapeutic agents across most drug classes and improve upon standard of care. I am very pleased to welcome Andy whose technical expertise and industry know-how coupled with his longstanding commitment to EXACT-Tx is a very strong addition to the leadership team. I look forward to working with him again as we further investigate this exciting approach to ultrasound mediated therapeutic targeting."