$nwbo @alphavestcap nwbio.com/northwest-biothera… xitter.cf/andrewcaravello/status… "The alpha-type-1 polarized dendritic cell (αDC1) vaccine is a highly specialized form of cellular immunotherapy. Normal dendritic cells act as the "generals" of the immune system, collecting information about threats and training T cells to attack them. The αDC1 platform, developed through the research pipeline led by Dr. Pawel Kalinski, is engineered to overcome a specific problem: tumors often hide from the immune system or actively shut down standard dendritic cells." "US Manufacturing Capacity. The technology transfer process for development of DCVax-L manufacturing capacity in a US company was completed, and the basic engineering runs and validation were undertaken and recently completed. For production of the Kalinski aDC1 products, the Company’s negotiations for lease arrangements for a suitable GMP facility continued. In light of the challenges encountered in reaching suitable lease arrangements for production of the Kalinski products, the Company anticipates making arrangements for a parallel process of technology transfer to the US company to which the technology transfer for production of DCVax-L products has been completed."-(6/30/26-10Q) sec.gov/ix?doc=/Archives/edg… sec.gov/ix?doc=/Archives/edg… sec.gov/ix?doc=/Archives/edg… nwbio.com/northwest-biothera…

$nwbo @alphavestcap xitter.cf/andrewcaravello/status… xitter.cf/METhompson72/status/21… federalregister.gov/document… xitter.cf/biggercapital/status/2… hhs.gov/press-room/fda-cms-a… xitter.cf/RareDiseases/status/21… xitter.cf/gr197667/status/211555… xitter.cf/alphavestcap/status/21… investorshub.advfn.com/board… xitter.cf/alphavestcap/status/21… xitter.cf/alphavestcap/status/21… xitter.cf/alphavestcap/status/21… investorshub.advfn.com/board… xitter.cf/alphavestcap/status/21… xitter.cf/SouthernDrive21/status… nwbio.com/northwest-biothera… nwbio.com/northwest-biothera… pgsd Wednesday, October 28, 2026 2:14:34 AM 'Difficult to ignore' The totality of the evidence is more consistent with a company preparing for a positive regulatory outcome than with a company expecting an imminent rejection. A few points stand out. 1. The timing is becoming increasingly significant If the DCVax-L MAA was submitted in December 2023, then by December 2026 the application will indeed have been under review for approximately three years. While novel biological products can experience lengthy reviews, it would be unusual for a company to continue investing in manufacturing infrastructure, regulatory staffing, logistics tracking systems and commercial readiness if it had already received a strong indication that rejection was inevitable. That does not mean approval is guaranteed, but management's actions matter. 2. The NHSBT collaboration is difficult to ignore The October 2026 announcement stated that NWBO and NHS Blood and Transplant had entered into a collaboration to support production of DCVax-L and that it was the culmination of months of joint efforts. NHSBT is not the sort of organisation that would casually devote resources to operational planning around a therapy if there were no realistic pathway towards future use. Could NHSBT collaborate before final approval? Absolutely. Would they usually do so if they believed rejection was imminent? That seems less likely, although we cannot know the internal discussions. 3. The technical team expansion is particularly interesting The latest announcement specifically states that NWBO is prioritising: scale-up of production capacity, restarting manufacturing in the US, creating backup capacity for UK production, preparing for clinical trials beyond brain cancer, enhancing QA and regulatory expertise, expanding IT systems for handling, distribution and tracking personalised vaccine products. The IT hire was explicitly described as helping prepare systems for scaling the handling, distribution and tracking of personalised cancer vaccine products. That sounds more like operational readiness than cost-cutting survival. The company also emphasised that the staffing changes resulted in a net increase in US headcount while keeping costs roughly flat. 4. Would MHRA give a "heads up"? MHRA generally cannot provide a formal decision before issuing a formal decision. However, in complex regulatory processes there can be: ongoing dialogue, review questions, requests for clarification, manufacturing inspections, discussions regarding labelling, discussions regarding post-approval commitments. Therefore, it is certainly plausible that a company develops a fairly good sense of where a review is heading before receiving the official decision. I think the key distinction is: A regulator may not say "you are approved". But the pattern of interactions may make management substantially more confident. That happens in many regulatory settings. 5. The strongest argument The strongest point is not any single press release. It is the combination of: Continued MHRA review without a rejection announcement. NHSBT collaboration. SPIMACO MOU announced earlier in 2026. Expansion of manufacturing and QA capabilities. Investment in product tracking and operational infrastructure. Continued discussion of expansion beyond glioblastoma. Taken together, these are actions one would more naturally associate with preparation for future commercial activity than with winding down an unsuccessful programme. NWBO is a capital-constrained company. A small biotech generally does not spend scarce resources on QA, regulatory, IT infrastructure, manufacturing scale-up and external collaborations unless management believes there is a realistic prospect those investments will be needed. Bottom line The NHSBT collaboration and the newly announced technical-team expansion are not proof that MHRA approval is imminent, but they are difficult to reconcile with a scenario in which NWBO already believes a rejection is coming. The behaviour of the company appears more consistent with management expecting continued progress toward commercialisation than with preparing for failure. On balance, the recent actions look more like preparation for success than preparation for rejection. Microsoft co-pilot AI [email protected]@alphavestcap·7h$nwbo @alphavestcapflipper44 Wednesday, October 28, 2026 10:57:35 AM . So, assume, as has been indirectly pointed out in 10Qs and PRs, that NHSBT CMT and TAS started working with NWBO on leukapheresis and lysate processing first/second quarter. Why not just announce before ViewsLast edited12:08 PM · Oct 28, 2026·371

$nwbo @alphavestcap AstraZeneca held talks with Bristol Myers Squibb on $400 billion megadeal, source says By Sabrina Valle and Michael ErmanAugust 2, 20263:36 PM EDTUpdated August 3, 2026📷Test tubes are seen in front of a displayed Bristol Myers Squibb logo in this illustration taken, May 21, 2021. REUTERS/Dado Ruvic/Illustration/File Photo Purchase Licensing Rights, opens new tabSummary Companies Astra declines to comment, Bristol Myers not available for comment Both companies have large cancer drug businesses Any deal would be first big pharma merger since 2020 Aug 2 (Reuters) - AstraZeneca Plc (AZN.L), opens new tab and Bristol Myers Squibb (BMY.N), opens new tab held preliminary discussions about a possible combination that would ​create one of the world's biggest pharmaceutical companies with a combined value of nearly $400 billion, according to a person familiar ‌with the situation.The Financial Times first reported the news. Reuters could not determine whether the talks are ongoing.Jumpstart your morning with the latest legal news delivered straight to your inbox from The Daily Docket newsletter. Sign up here.A potential deal would carry regulatory risk because of concerns about how it might be assessed by U.S. antitrust authorities under President Donald Trump's administration, the person said on condition of anonymity. Trump has been focusing on ​domestic investments in the sector and expanding U.S. manufacturing.Advertisement · Scroll to continue📷While AstraZeneca last year unveiled plans for a direct U.S. listing, aiming to capitalize ​on stronger valuations in the U.S. market, such a deal would mean a UK-based company would effectively be buying a ⁠major U.S. pharmaceutical champion.AstraZeneca declined to comment, while Bristol Myers did not immediately respond to a Reuters request for comment. STRONG GROWTH IN CANCER ​DRUGS AstraZeneca's share price has more than quadrupled during Pascal Soriot's 14-year tenure as CEO, soaring above the wider FTSE 100 index and main British rival GSK (GSK.L), opens new tab.Second-quarter results ​last week showed strong demand for cancer and rare-disease drugs continues to drive AstraZeneca's growth. Cancer treatments accounted for about $25 billion in 2025 sales, nearly half of the total, followed by cardiovascular, renal and metabolism treatments worth about $12 billion.Advertisement · Scroll to continue📷Oncology drugs accounted for more than 40% of Bristol Myers' overall sales in the first six months of 2026, and the two companies' ​cancer immunotherapies directly compete."I would expect a Trump FTC to scrutinize the merger, and if there are significant overlaps in certain drugs and late-stage pipeline overlaps, ​it would require meaningful divestitures," said Andre Barlow, an antitrust lawyer with DBM Law Group, referring to the U.S. Federal Trade Commission.Bristol Myers has been doing smaller deals ‌to gain ⁠new drugs as it faces declining sales of older medicines, some of which will soon face generic competition.In 2019, Bristol Myers bought Celgene for about $80 billion, acquiring its flagship blood cancer drug Revlimid, which became Bristol's top-selling product. Revlimid has already lost patent protection and its current top sellers — cancer immunotherapy Opdivo and blood thinner Eliquis — could lose patent protection by 2028.The video player is currently playing an ad.00:0000:00📷00:05Market Talk: Why is the Fed waiting to hike?Barlow noted that in the deal for Celgene, the Trump FTC required ​Celgene to sell psoriasis treatment Otezla, opens new tab, a ​major divestiture at $13.4 billion."There is bipartisan ⁠support to scrutinize pharma deals, so I would imagine that even the Trump FTC would ask the broader questions relating to bundling of products and a lack of future innovation, in addition to scrutinizing all direct ​overlaps," he said.Bristol Myers raised its full-year revenue and profit forecast last week as strong sales of Eliquis and ​newer medicines pushed second-quarter ⁠results well past analysts' estimates.Its promising newer drugs and pipeline assets include an experimental blood thinner milvexian, anemia treatment Reblozyl and heart drug Camzyos.Consideration of the potential deal comes about a dozen years after AstraZeneca fended off a takeover attempt by larger U.S. rival Pfizer (PFE.N), opens new tab.Advertisement · Scroll to continue📷Large pharmaceutical deals have been rare in recent years, ⁠in part ​due to concerns about antitrust and U.S. pressure to keep drug prices low. Besides the ​Bristol Myers and Celgene deal, AbbVie (ABBV.N), opens new tab bought Allergan in 2020 and Takeda and Shire combined in 2019.Reporting by Sabrina Valle and Michael ​Erman in New York and Devika Nair in Bengaluru; Additional reporting by Chris Sanders in Washington; Editing by Caroline Humer, Bill Berkrot and Paul SimaoOur Standards: The Thomson Reuters Trust Principles., opens new tabSuggested Topics: 📷Sabrina ValleThomson ReutersNY-based correspondent reporting on some of the largest deals in Healthcare and Industrials. Previously based in Houston, covering global operations of U.S. oil majors. Sabrina has a two-decade career in Business reporting, with a strong background in source-based enterprise and investigations. She previously worked at Bloomberg, Washington Post and has been based in Rio and D.C. covering large corporations, including finance, corruption and geopolitics.

$nwbo @alphavestcap xitter.cf/gr197667/status/211555…

xitter.cf/sharpie510/status/2115… $nwbo @alphavestcap

$nwbo @alphavestcap Before the MAA could be issued, the MHRA wanted the FDA to approve dc vax L 's BLA. The MHRA's signal to the FDA that the MAA would be approved was (nwbio.com/northwest-biothera…).Stephen Moore then (xitter.cf/HollensbeAmanda/status…) signals to the MHRA that the FDA approval will be "right to try". GMP approval in the U.S. is signaled to the MHRA by (nwbio.com/northwest-biothera…) and especially with Shannon joining $nwbo. $nwbo had signaled long ago that the GMP certification process had started a year ago.(10Q-6/30/26-sec.gov/Archives/edgar/data/… ) xitter.cf/HollensbeAmanda/status… xitter.cf/alphavestcap/status/21… xitter.cf/DCVaxDefender/status/2… nwbio.com/northwest-biothera… nwbio.com/northwest-biothera…

$nwbo @alphavestcap investorshub.advfn.com/board… xitter.cf/alphavestcap/status/21… xitter.cf/alphavestcap/status/21… xitter.cf/alphavestcap/status/21… investorshub.advfn.com/board… xitter.cf/alphavestcap/status/21… xitter.cf/SouthernDrive21/status… nwbio.com/northwest-biothera… nwbio.com/northwest-biothera… pgsd Wednesday, October 28, 2026 2:14:34 AM 'Difficult to ignore' The totality of the evidence is more consistent with a company preparing for a positive regulatory outcome than with a company expecting an imminent rejection. A few points stand out. 1. The timing is becoming increasingly significant If the DCVax-L MAA was submitted in December 2023, then by December 2026 the application will indeed have been under review for approximately three years. While novel biological products can experience lengthy reviews, it would be unusual for a company to continue investing in manufacturing infrastructure, regulatory staffing, logistics tracking systems and commercial readiness if it had already received a strong indication that rejection was inevitable. That does not mean approval is guaranteed, but management's actions matter. 2. The NHSBT collaboration is difficult to ignore The October 2026 announcement stated that NWBO and NHS Blood and Transplant had entered into a collaboration to support production of DCVax-L and that it was the culmination of months of joint efforts. NHSBT is not the sort of organisation that would casually devote resources to operational planning around a therapy if there were no realistic pathway towards future use. Could NHSBT collaborate before final approval? Absolutely. Would they usually do so if they believed rejection was imminent? That seems less likely, although we cannot know the internal discussions. 3. The technical team expansion is particularly interesting The latest announcement specifically states that NWBO is prioritising: scale-up of production capacity, restarting manufacturing in the US, creating backup capacity for UK production, preparing for clinical trials beyond brain cancer, enhancing QA and regulatory expertise, expanding IT systems for handling, distribution and tracking personalised vaccine products. The IT hire was explicitly described as helping prepare systems for scaling the handling, distribution and tracking of personalised cancer vaccine products. That sounds more like operational readiness than cost-cutting survival. The company also emphasised that the staffing changes resulted in a net increase in US headcount while keeping costs roughly flat. 4. Would MHRA give a "heads up"? MHRA generally cannot provide a formal decision before issuing a formal decision. However, in complex regulatory processes there can be: ongoing dialogue, review questions, requests for clarification, manufacturing inspections, discussions regarding labelling, discussions regarding post-approval commitments. Therefore, it is certainly plausible that a company develops a fairly good sense of where a review is heading before receiving the official decision. I think the key distinction is: A regulator may not say "you are approved". But the pattern of interactions may make management substantially more confident. That happens in many regulatory settings. 5. The strongest argument The strongest point is not any single press release. It is the combination of: Continued MHRA review without a rejection announcement. NHSBT collaboration. SPIMACO MOU announced earlier in 2026. Expansion of manufacturing and QA capabilities. Investment in product tracking and operational infrastructure. Continued discussion of expansion beyond glioblastoma. Taken together, these are actions one would more naturally associate with preparation for future commercial activity than with winding down an unsuccessful programme. NWBO is a capital-constrained company. A small biotech generally does not spend scarce resources on QA, regulatory, IT infrastructure, manufacturing scale-up and external collaborations unless management believes there is a realistic prospect those investments will be needed. Bottom line The NHSBT collaboration and the newly announced technical-team expansion are not proof that MHRA approval is imminent, but they are difficult to reconcile with a scenario in which NWBO already believes a rejection is coming. The behaviour of the company appears more consistent with management expecting continued progress toward commercialisation than with preparing for failure. On balance, the recent actions look more like preparation for success than preparation for rejection. Microsoft co-pilot AI Analysis

$nwbo @alphavestcap flipper44 Wednesday, October 28, 2026 10:57:35 AM . So, assume, as has been indirectly pointed out in 10Qs and PRs, that NHSBT CMT and TAS started working with NWBO on leukapheresis and lysate processing first/second quarter. Why not just announce before pre-hearing? 1. Timing after 2025 CHM hearing did not allow this. 2. Perhaps less obvious and more important, that CMC solution worked through (example: completed tech transfer, dry runs, validation, etc) by the parties still certainly needed a green light for final agreement, and the CHM pre-hearing, which stated to the parties (around Sept 1) far more than the minutes publicly provided, something like, “hey, yeah, these are indeed the remaining CMC hurdles,” upon which NHSBT TAS CMT Leeds Oxford and NWBO said something like, “great, let’s execute/sign this and announce it publicly”, then, as CHM also likely said we want to see backup efforts restarting in USA for back up expansion capacity, NWBO publicly announced restarting capacity in USA to back up UK future expansion. IMO.

$nwbo @alphavestcap xitter.cf/alphavestcap/status/21… investorshub.advfn.com/board… xitter.cf/alphavestcap/status/21… xitter.cf/SouthernDrive21/status… nwbio.com/northwest-biothera… nwbio.com/northwest-biothera… "She and Kalinski even appear together on a 2025 scientific abstract involving dendritic-cell immunotherapy."