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3/12/2024 1:38:01 PM - Fluoguide: Delivering on promises - Redeye - Redeye is encouraged by Fluoguide delivering on its promises by entering a collaboration in head and neck RAS with market leader Intuitive Surgical. We understand that the collaboration is non-exclusive and does not imply any immediate financial benefits for Fluoguide. However, we judge it validates FG001’s potential and could pave the way for a more intensive collaboration down the road, as well as possible additional partnerships with other actors.
3/12/2024 12:19:35 PM - Fluoguide: First partnership agreement is validating - SEB - Fluoguide signed its first partnership, a non-exclusive collaboration with Intuitive Surgical to develop FG001 for tumour imaging and surgical margin assessment in head and neck cancer, using Intuitive's equipment. We believe it has multiple other ongoing discussions, but this agreement is an initial partial validation of Fluoguide's approach and does not give anything away (albeit at the cost of no upfront) while securing free access to Intuitive's equipment. Positive.
3/12/2024 11:23:44 AM - Fluoguide ingår samarbete med Intuitive Surgical inom robotassisterad kirurgi - Danska forskningsbolaget Fluoguide ingår ett samarbete med amerikanska Intuitive Surgical, vilket är ett företag inom robotassisterad kirurgi. Det framgår av ett pressmeddelande.
2/29/2024 6:28:15 AM - Fluoguide: New ambitious targets for 2024 issued - SEB - Fluoguide reported slightly higher costs in Q4 than we expected, but the clinical programme remains on track for now, and Fluoguide has sufficient cash to fund operations through 2024. Management has issued guidance for operational and strategic KPIs, including to partner FG001. We expect 2024 to be an exciting year for Fluoguide. We reiterate our SEK 173-188 per share equity valuation range.
2/28/2024 11:48:28 AM - Fluoguide Q4 2023: Bright prospects - Redeye - Redeye comments on Fluoguide’s Q4 2023 report, with the company having recently communicated a strategy update. We believe the company’s new strategy is value-accretive overall, though it likely delays a potential market approval for FG001 by c6-12 months. We do some housekeeping in our model and leave our estimates and valuation largely unchanged.
2/28/2024 7:27:45 AM - Fluoguide ökar förlusten - Forskningsbolaget Fluoguide redovisar som planerat ingen omsättning under helåret 2023. Rörelseförlusten ökade.
2/23/2024 3:13:19 PM - Fluoguide tilldelar warrants till finanschefen - Forskningsbolaget Fluoguide tilldelar 45 000 warrants till finanschefen Ole Larsen.
1/12/2024 6:27:42 AM - Fluoguide: Value-accretive strategy shift - Redeye - Redeye updates its estimates following Fluoguide presenting its strategic update. We judge the company’s updated strategy as interesting from both a clinical and business development perspective. While it will likely maximise FG001’s commercial potential, it will also delay clinical development, arguably diverging from Fluoguide’s previous aim to reach the market as fast as possible. Overall, we endorse the company’s updated strategy and view it as value-accretive.
1/9/2024 6:28:50 AM - Fluoguide makes the jump to light speed - SEB - At SEB’s Nordic Seminar, we learned Fluoguide has decided to accelerate development of FG001 for photothermal therapy (PTT), as we hoped. Inevitably, this will result in a delay in pivotal study start, as we expected, but as we argued in our 13 Nov comment, it is a 'no-brainer'. Although details still need to be ironed out with the FDA and EMA, the decision strongly reinforces our confidence that mgmt takes sound, data-driven decisions that favour long-term value creation.
1/8/2024 12:35:17 PM - Fluoguide: Prioritises HGG, PTT, and HNC in FG001’s clinical development - Redeye - Redeye provides an initial comment on Fluoguide communicating a strategic update for FG001’s clinical development. We endorse the company prioritising high-grade glioma and head and neck cancer as indications, likely offering the best risk/reward overall. Further, we understand that Fluoguide intends to explore combining fluorescence-guided surgery and photothermal therapy in future HGG trials, increasing the product candidate’s potential value but also delaying pivotal trials by around one year versus our previous estimate. We will await the company’s presentation of its strategic update on Wednesday this week before adjusting our estimates and valuation to account for the company’s updated clinical development plans.
11/30/2023 7:09:10 AM - Fluoguide: Next step - FDA feedback on brain cancer ph3 - SEB - Fluoguide has progressed well clinically. Up next are regulatory talks about its glioblastoma ph3. We would like to get a closer look at the ph2b data, but at this point (admittedly on limited info) we identify no red flags. Photothermal therapy (PTT) will be accelerated, we believe, but the next step is a regulatory meeting on brain cancer. Cash is sufficient at least to mid-2024 and stretchable to 2025. We reiterate our equity valuation range of SEK 173-188 per share.
11/29/2023 11:17:10 AM - Fluoguide Q3 2023: Spoilt for choice - Redeye - Redeye comments on Fluoguide’s Q3 2023 report, with the company reporting two solid phase II readouts since our last update. We expect Fluoguide to present its later-stage clinical development plan for FG001 in coming months and do some housekeeping in our model.
11/14/2023 7:40:33 AM - Fluoguide: Phase IIb HGG data paves FG001’s way to phase III - Redeye - Redeye judges Fluoguide’s phase IIb trial with FG001 in high-grade glioma meeting its primary endpoint aligned with our expectations. Notably, FG001 seemed superior to white light, enabling the removal of additional cancer tissue in all treated patients. Reported results for the trial’s 5-ALA group were similar. So far, so good. We nudge up our valuation and will consider further changes once the company communicates how it plans to proceed with FG001’s clinical development.
11/13/2023 9:01:58 AM - Fluoguide: Ph2b aggressive glioma trial met primary endpoint - SEB - Fluoguide announced top-line ph2b data for FG001: it enabled detection and removal of residual cancer tissue after initial tumour resection in 12/12 patients, and hence was positive. That said, the comparator, 5-ALA, did the same, and 6 patients in each arm had residual cancer too close to eloquent brain areas, and judged inoperable, opening for debate whether the ph3 trial should already assess FG001 in photothermal therapy, which would be a hugely positive development.
11/6/2023 10:10:20 AM - Fluoguide: Phase IIa head and neck cancer top-line data align with our expectations - Redeye - Redeye notes Fluoguide announcing phase IIa top-line data with FG001 in head and neck cancer. Based on previous interim data, we judge that the announced data align with our expectations, showing that FG001 lit up cancer at 4-36 mg doses in all 16 patients with relevant tumour-to-background ratios and no serious adverse events. We nudge up our valuation.
8/31/2023 5:38:11 AM - Fluoguide: First decisive data likely positive, in November - SEB - As usual, there were no material surprises in Fluoguide’s Q2 report, and the company has cash to get through H1/24 at least. A major readout in aggressive glioma is due in November and we expect it to be positive, showing that lead drug FG001 offers superior tumour resection versus the standard of care. We think management has excelled at delivering on its timelines and delivering good data. We reiterate our fair equity value range of SEK 173-188 per share.
8/30/2023 11:47:14 AM - Fluoguide Q2 2023: Closing in on high-impact catalysts - Redeye - Redeye comments on Fluoguide’s Q2 2023 report as top-line data from the company’s phase IIb trial in high-grade glioma are just around the corner in Q4 2023e. We judge that positive phase IIb HGG and phase IIa HNSCC data are critical to FG001’s clinical development, associated funding, and attracting potential partners.
8/30/2023 7:08:15 AM - Fluoguide Q2: impressive progress on pipeline; decent cash runway - SEB - Fluoguide reported a Q2 EBIT loss of DKK 8.66m and a DKK 8.06m cash position, which excludes the DKK 15m raised in July and the additional DKK 25m in warrants that can be exercised in Nov-23. During the quarter, Fluoguide completed recruitment to its aggressive glioma trial and further positive data in its head and neck cancer ph2 trial were announced. On the back of this impressive progress, we expect to reiterate our equity valuation range (mid-point SEK 180 p.s.).
8/29/2023 6:40:45 AM - FluoGuide: A November-ish date with randomised data in aggressive glioma - SEB - FluoGuide announced enrolment completion for its ph2b randomised trial of FG001 vs. 5-ALA in aggressive glioma, and expects to report topline in 2-3 months (i.e., probably during November 2023). The trial has a high probability of demonstrating superior removal cancer tissue, in our view, and is yet another impressive example of management's ability to rapidly set up trials and recruit patients.
7/6/2023 5:33:04 AM - Fluoguide: cSEK15m directed share issue increases financial flexibility - Redeye - Redeye is encouraged by Fluoguide carrying out a smaller directed share issue of cSEK15m in gross proceeds. The issue price of SEK72.33 per share amounts to a c12-13% discount to the previous day’s closing price, representing a fairly small discount relative to other recent share issues in the Life Science sector. Additionally, warrants issued in connection with the directed share issue could bring in an additional cSEK11m-25m in Q4 2023e. We positively view the company shoring up its cash position to increase financial flexibility and broaden its institutional investor base. Given the minor size of the announced capital raise, our valuation and estimates remain essentially unchanged.
6/20/2023 7:06:09 AM - FluoGuide: Yet another successful ph2a result, this time in head & neck cancer - SEB - FluoGuide announced successful interim results in head and neck cancer, with 100% (12/12) of patients' tumours illuminated by FG001 - a small de-risking event, in our view. Together with results from glioma and lung cancer, the data offers further validation that FG001 has broad utility in fluorescence-guided surgery (FGS). Dose-finding is still underway, and full topline is expected in H2/23, with proof-of-concept efficacy data in FGS for glioblastoma also due during H2/23.
6/9/2023 1:50:41 PM - Fluoguide: Positive top line in ph2a lung cancer trial - SEB - Once again, Fluoguide has managed to turn out a positive top line result in a clinical trial, this time in lung cancer, in which 73% of patients' cancers were illuminated by FG001, with continued a clean safety/tolerability profile and similar pharmacokinetics to that seen in glioma. In our view, this is a promising start to the lung cancer programme and a de-risking event, albeit perhaps not to the same extent as for the earlier glioma and interim head and neck data.
6/8/2023 7:16:08 AM - Fluoguide: First of three phase II top-line readouts for 2023e in the books - Redeye - Redeye comments on Fluoguide posting solid phase IIa NSCLC data, providing the first out of three phase II top-line readouts that the company expects to communicate in 2023e. We judge that NSCLC provides an attractive indication for continued FG001 clinical development. However, depending on coming phase II readouts, it might not represent the lowest-hanging fruit for FG001 in the near term. We nudge up our valuation.
6/1/2023 6:39:33 AM - Fluoguide: Lots of triggers yet to come in 2023 - SEB - Fluoguide reported Q1 results and provided an update on its clinical programme that will see head and neck cancer increasingly prioritised over lung cancer in the development timeline. We expect positive readouts from several major trials over the remainder of 2023 that investors should keep a close eye on, as they are major de-risking events in our view.
6/1/2023 5:14:04 AM - Fluoguide Q1 2023: A watched pot never boils - Redeye - Redeye comments on Fluoguide’s Q1 2023 report as we close in on multiple high-impact catalysts in 2023e. Fluoguide recently updated the market on the timing of readouts and patient recruitment of its ongoing phase II trials. While the new timeline guidance slightly diverged from our previous estimates, we judge that the equity story remains unchanged.
5/30/2023 11:10:22 AM - Fluoguide står inför flera milstolpar med studieresultat i närtid - vd - Danska forskningsbolaget Fluoguide vd Morten Albrechtsen presenterade bolaget vid Sedermeradagen i Stockholm på tisdagen.
5/25/2023 5:30:00 AM - Fluoguide: Phase II readouts drawing closer - Redeye - Redeye comments on Fluoguide providing an update on its clinical trial progress. Updated timeline guidance mostly aligns with our expectations, except for a delay of phase IIa HNSCC top-line data to H2 2023e versus our previous estimate of mid-2023e. Considering promising interim data and the HNSCC delay relating to a trial expansion, our view of Fluoguide’s investment case remains essentially unchanged.
3/1/2023 6:46:32 AM - Fluoguide Q4 2022: Slightly shifted timelines but equity story remains unchanged - Redeye - Redeye comments on Fluoguide’s Q4 2022 report as we enter a catalyst-rich 2023e for the company. Fluoguide recently announced a slight delay in phase IIb HGG top-line data, though we judge that the company’s equity story remains unchanged following the news.
2/23/2023 6:39:59 AM - FluoGuide: Key H1/23 readouts; head and neck modelled - SEB - Major surprises from the Q4 report seem unlikely to us. We cut our opex estimates in line with the recent cost trajectory and to reflect management’s view that FluoGuide has a cash runway through Q1/24 sufficient to cover its ongoing clinical trials. FluoGuide has several major trial readouts in 2023 that we deem to have a high probability of success and major de-risking potential. We also add head and neck cancer to our valuation of FG001.
1/10/2023 7:31:48 AM - Fluoguide: Positive head-and-neck cancer data bode well for 2023 performance - SEB - At SEB's Nordic Seminar, we spoke with CEO Morten Albrechtsen, who noted the exciting news from this morning that lead drug FG001 has now demonstrated an ability to delineate tumours in patients across three different cancer types, with head and neck the latest. We expect phase 2 data in H1/23 from FluoGuide across all three cancers, and it is highly likely to be positive, which seems well timed vis-a-vis a likely easing of the equities bear market.
1/10/2023 7:07:46 AM - Positive head-and-neck cancer data bode well for 2023 performance - SEB - At SEB's Nordic Seminar, we spoke with CEO Morten Albrechtsen, who noted the exciting news from this morning that lead drug FG001 has now demonstrated an ability to delineate tumours in patients across three different cancer types, with head and neck the latest. We expect phase 2 data in H1/23 from FluoGuide across all three cancers, and it is highly likely to be positive, which seems well timed vis-a-vis a likely easing of the equities bear market.
11/24/2022 11:11:27 AM - Fluoguide: Critical catalysts for FG001 in 2023e - Redeye - Redeye comments on Fluoguide’s Q3 2022 report at a time when the company is approaching multiple critical catalysts in the coming 12 months. We judge that the company is making solid clinical progress and make some technical adjustments to our model.
11/7/2022 1:01:06 PM - Fluoguide: NSCLC interim data aligns with our expectations - Redeye - Redeye comments on Fluoguide posting interim data from its phase IIa trial with FG001 in NSCLC (FG001-CT002). FG001-CT002 interim data from the first eight patients aligned with our expectations, showing good tolerability and cancer tissue lighting up in most patients. We leave our estimates unchanged but view the communicated data as an incremental positive.
8/26/2022 5:50:27 AM - Fluoguide: Growing opportunity, with triggers around the corner - SEB - As usual, earnings themselves held few surprises. The operating loss was lower than expected, mainly due to trial timelines having shifted back a half year or so after the extension of the phase 1 glioblastoma trial. With DKK 39.1m in cash, Fluoguide has sufficient funding to reach data readouts in its various phase 2 trials. The next major event is the phase 2a topline from lung cancer, in Q4/22, with both the advanced glioma and head and neck cancer trial readout in H1/23.
8/25/2022 1:20:56 PM - Fluoguide Q2: A broadening pipeline - Redeye - Redeye comments on Fluoguide’s Q2 2022 report, and we judge that the company is laser-focused on delivering catalysts that will bring FG001 into the limelight in the coming six to 12 months. Further, the company provided a general update on FG001’s clinical development timeline and announced head and neck cancer as a new indication. We fine-tune our estimates.
8/25/2022 10:57:17 AM - Fluoguide Q2: Clinical program progressing, albeit delayed by good results - SEB - We already knew that the clinical program for FG001 would take a little longer, due to its unexpectedly strong clinical profile as an imaging agent, but we now have clarity on what it means for the timeline, with potential approval pushed back until 2025, though the commercial opportunity remains essentially unchanged.
8/25/2022 5:28:24 AM - Fluoguide: Successful phase 1/2a data in aggressive glioma - SEB - Fluoguide announced that its phase 1/2a trial in aggressive glioma was successful, with 100% of patient biopsies illuminated at the high dose of FG001, and only 3/40 patients showing side-effects, all of which were mild, according to the company. As a result, the phase 2b trial will be expanded to 24 patients with aggressive glioma, instead of 12 previously. Fluoguide will run a trial of FG001 in head and neck cancer, an adjacent opportunity not in our model. Positive.
6/1/2022 5:56:39 AM - FluoGuide 2022: Catalyst Cornucopia - SEB - As we expected, the Q1 report itself bore no surprises but served to highlight FluoGuide’s progress in de-risking and diversifying its R&D programme. The Q1 result was better than we expected, owing mainly to a more rapid closure of activities from the ph1/2 clinical trial, as well as grant income. The key near-term milestones are the high-grade glioma efficacy readout and phase 2a lung cancer trial, both by YE 2022, through which FluoGuide is financed.
5/31/2022 12:32:24 PM - Fluoguide Q1 2022: Our comment - Redeye - Redeye briefly comments on Fluoguide’s Q1 2022 report. We believe the company has executed some important milestones during the first five months of 2022, raising capital and presenting solid FG001 safety and efficacy data from part 1 of its phase I/II trial in high-grade glioma. We see top-line data from the second part (phase IIb) of Fluoguide’s phase I/II trial in high-grade glioma and its phase II trial in lung cancer as the main remaining catalysts for the stock in 2022.
5/18/2022 8:19:51 AM - Fluoguide: FG001 shines again - Redeye - Redeye comments on Fluoguide presenting clinical trial data from its phase I/II trial in aggressive brain cancer. We judge the presented data further strengthen evidence around FG001’s efficacy in this indication and bode well for the coming top-line data readout later this year. We increase our estimated LoA for FG001 in aggressive brain cancer and raise our Base Case.
4/4/2022 9:01:49 AM - Fluoguide: Part 1 of phase I/II high-grade glioma trial successfully completed - Redeye - Redeye is encouraged by Fluoguide communicating excellent safety and promising early signs of efficacy from the completed first part of its phase I/II high-grade glioma trial. Overall, 40 patients received FG001 treatment, and the company has determined optimal timing and dose for part 2 of the trial. Histology data confirmed FG001 lighting up aggressive brain cancer tissue. We judge that the presented results confirm the promising part 1 results that the company announced last year, but we would like to see more granular histology data in the future.
4/4/2022 5:31:53 AM - FluoGuide: The verdict on part 1 of the ph1/2 study is in: FG001 works - SEB - FluoGuide announced that the tissues surgically removed using FG001 during the dose-escalation phase of its phase 1/2 trial were, as anticipated, cancerous, confirming that FG001 has positive predictive value. The second part of the trial will give us a clearer view of how big that predictive value is, and the data should be ready by mid-year. Positive but largely expected, so we expect a modestly positive reaction.
3/31/2022 8:54:18 AM - Fluoguide: Imminent ph2 readout seems underappreciated - SEB - With phase 2 topline data expected to read out in the next few months, it will be worth watching FluoGuide carefully because our impression is that market expectations are not as high as our own. We anticipate getting a sense of the predictive value of FG001 in glioma surgery, which we believe will be strong, given what has already been announced.
3/30/2022 2:00:12 PM - Fluoguide Q4 2021: Calm Before the Storm - Redeye - Redeye comments on Fluoguide’s Q4 report, following a relatively calm couple of months on the news front. However, the company faces multiple potential catalysts during 2022, including high-grade glioma and NSCLC phase II readouts. The share has taken some beating recently, and we believe a lower share price and multiple upcoming catalysts could provide an attractive entry point.
3/30/2022 7:05:02 AM - Fluoguide Q4: Case intact - SEB - Q4 EBIT was DKK -9.6m vs. SEB at DKK -11.9m. Cash amounted to DKK 47m as of the year-end, however, this is complemented by a SEK 25m in a directed issue carried out in March 2022. With the cash position FluoGuide comments that it can finance the two phase II results (brain and lung) with FG001 and provide flexibility in timing of next funding. Nothing in the report that changes our view on the case.
3/11/2022 12:39:34 PM - Fluoguide: Directed share issue completed - Redeye - Redeye briefly comments on Fluoguide’s directed share issue of some SEK 25m in gross proceeds, announced yesterday evening. As emphasized in our previous notes, we expected Fluoguide to address financing this year, and the announced capital raise is thus in line with our expectations. The share issue results in minimal dilution of existing shareholders, and we marginally adjust our valuation as a result.
1/13/2022 2:49:32 PM - FluoGuide looks to maximise potential pricing power - SEB - At SEB's Nordic Seminar, FluoGuide CEO Morten Albrechtsen clearly laid out the equity story and discussed the path to approval and reimbursement. We were particularly interested in his thoughts about the need for flexibility in the clinical programme to be able to demonstrate clinical efficacy, superiority, and methods of use, in order to maximise reimbursement. We were also encouraged that FluoGuide's clinical program continues to be on track.
1/13/2022 6:47:38 AM - FluoGuide looks to maximise potential pricing power - SEB - At SEB's Nordic Seminar, FluoGuide CEO Morten Albrechtsen clearly laid out the equity story and discussed the path to approval and reimbursement. We were particularly interested in his thoughts about the need for flexibility in the clinical programme to be able to demonstrate clinical efficacy, superiority, and methods of use, in order to maximise reimbursement. We were also encouraged that FluoGuide's clinical program continues to be on track.
12/22/2021 11:17:29 AM - Fluoguide lämnar in CTA-ansökan för fas 2-tester med FG001 - Forskningsbolaget Fluoguide har lämnat in en CTA-ansökan (Clinical Trial Application) till danska läkemedelsverket om att få inleda fas 2-tester med FG001 i lungcancer. Det framgår av ett pressmeddelande.
11/16/2021 7:52:12 AM - Fluoguide: Flawless execution so far, but real trial to come - SEB - FluoGuide continues to do a good job of managing the progress of its clinical program, in our view, with no delays to date except a small one that occurred because FG001 worked better in the clinical trial than expected. As the program gathers complexity, we think it will be harder to maintain this flawless track record, but this is an encouraging start. Meanwhile, new products and trials create upside potential to our valuation range.
11/15/2021 2:03:02 PM - Fluoguide Q3 2021: Eventful times - Redeye - Redeye comments on Fluoguide’s Q3 2021 report, following an eventful period for the company. From now on, we view clinical trial data as the primary catalyst that can induce a share price re-rating.
11/15/2021 9:24:17 AM - Fluoguide Q3: Progressing according to plan - SEB - FluoGuide reported Q3 EBIT of DKK -8.9m (vs. SEB at DKK -11.9m) and EPS of DKK -0.71 (vs. SEB at DKK -0.82). Pipeline and regulatory timelines appears to be intact. Cash position stands at DKK 46m. Nothing in the report that changes our view on the case.
11/15/2021 7:47:48 AM - Fluoguide ökar förlusten i tredje kvartalet. - Forskningsbolaget Fluoguide ökar förlusten i tredje kvartalet jämfört med samma period föregående år. Som väntat redovisas ingen omsättning.
11/10/2021 12:51:48 PM - Fluoguide: Phase II trial in lung cancer to start in early 2022 - Redeye - Redeye comments on Fluoguide announcing lung cancer as the next indication for FG001. Today’s announcement is in line with our estimations and, as such, does not come as a surprise. Nevertheless, we are encouraged by Fluoguide delivering on its planned clinical pipeline broadening, crucial to our investment thesis.
11/10/2021 12:50:23 PM - Fluoguide: Expanding clinical development programme for FG001 - SEB - FluoGuide announced that it has determined to develop FG001 for non-metastatic lung cancer, the second indication after high-grade glioma, and that it will initiate a phase 2 trial around the start of 2022, with enrollment of up to 24 patients planned and top-line results expected by YE-2022. Lung cancer is a far larger indication than glioma and it is good to see management continuing to make rapid progress with its pipeline. Small positive.
11/10/2021 9:32:07 AM - Fluoguide: Case report bodes well for FG001 in meningioma - Redeye - Redeye comments on publication of a case report from Fluoguide’s ongoing phase I/II trial. The case report shows that FG001 appeared helpful in surgical guidance in a meningioma patient who was wrongly diagnosed with high-grade glioma pre-surgery. Fluoguide had already announced inclusion of two non-high-grade glioma patients earlier, and we judge the report requires cautious interpretation given it only features a single patient. Still, the data strengthen our conviction in FG001’s applicability outside of high-grade glioma. We include meningioma in our sales model and raise our Base Case.
11/10/2021 8:04:33 AM - Fluoguide väljer lungcancer som nästa indikation för FG001 - ska inleda fas II-studie i början av 2022 - Forskningsbolaget Fluoguide väljer lungcancer som den andra kliniska indikationen för FG001 och en fas II-studie kommer att påbörjas under början av 2022. Det framgår av ett pressmeddelande.
11/1/2021 10:48:31 AM - Fluoguide initierar preklinisk utveckling med FG002 - Forskningsbolaget Fluoguide har initierat den prekliniska utvecklingen av FG002 inom flourescensstyrd kirurgi för cancer. Det framgår av ett pressmeddelande.
10/12/2021 9:02:52 AM - Redeye inleder bevakning på Fluoguide med basscenario 98 kronor - Redeye inleder bevakning på forskningsbolaget Fluoguide och sätter ett basscenario om 98 kronor per aktie. Det framgår av en uppdragsanalys.
10/12/2021 8:06:44 AM - Fluoguide: Lighting Up Cancer Surgery - Redeye - Redeye initiates coverage of Fluoguide, a Denmark-based medtech company developing optical probes for fluorescence-guided cancer surgery. The company is about to conclude a phase I/II trial in high-grade glioma and has set its sight on market approval for lead candidate FG001 in 2025. Through label expansion into other, more prevalent cancers, we believe lead candidate FG001 has blockbuster potential.
10/11/2021 5:49:11 AM - Fluoguide: Trial part 1 complete with apparently good safety profile for FG001 - SEB - Management announced Friday afternoon that lead product FG001 was found safe and to have lit up brain tumours in 25 of 27 pts in part 1 of its phase 1/2 trial. With an optimal dose now selected, the next step will be to optimise dose timing, so management expects part 2 (the efficacy part) of the trial to begin in Q1/22, as previously guided. We have yet to see safety data, but, overall, it appears to be about as good a result as one could hope for. Small positive.
10/8/2021 2:07:23 PM - Fluoguide rapporterar positiva resultat för FG001 i säkerhets- och toleransstudie - Forskningsbolaget Fluoguide rapporterar ett läkemedelskandidaten FG001 visat sig vara säker och tolereras väl i en doseskalering i den pågående kliniska fas I/II-studien. Säkerhetsdata från 27 patienter med aggressiv hjärncancer har granskats och FG001 har visat sig ha en mycket tillfredsställande profil för säkerhet och tolerans hos alla 27 patienter. I den slutförda sjunde kohorten detekterades ljus hos alla tre patienterna, skriver bolaget i ett pressmeddelande.
9/14/2021 6:13:47 AM - Fluoguide fortsätter till sjunde dosnivån med FG001 - Forskningsbolaget Fluoguide fortsätter till sjunde dosnivån (36 mg) med Fg001 i den pågående kliniska fas I/II-studien efter fortsatt förbättring av tumörbelysning med ökande doser. Det framgår av ett pressmeddelande.
8/26/2021 8:02:10 AM - Fluoguide får grönt ljus för fas 2-tester med FG001 i Sverige - Forskningsbolaget Fluoguide får inleda fas 2-tester med FG001 mot höggradig glioma i Sverige efter myndighetstillstånd. Det framgår av ett pressmeddelande.
8/26/2021 7:15:18 AM - Fluoguide: Continued progress - SEB - FluoGuide has been demonstrating good progress with its clinical and preclinical programs, and FG001 appears to be exceeding expectations, with higher optimal dosing than the company projected. Although in principle, this is positive because it means a better product, it also means more testing of doses, and hence delays to the start of part 2 of the trial. We have adjusted our model accordingly.
8/26/2021 5:55:58 AM - SEB justerar sitt NPV-värde för Fluoguide - SEB justerar nu sitt NPV-värde för forskningsbolaget Fluoguide. Banken har satt ett värde om 104-138 kronor, en justering från tidigare 108-140. Det framgår av en färsk analys.
8/25/2021 6:37:38 AM - Fluoguide minskar rörelseförlusten under andra kvartalet - Forskningsbolaget Fluoguide redovisar som planerat ingen omsättning under andra kvartalet. Rörelseförlusten minskade.
8/23/2021 7:15:05 AM - Fluoguide rapporterar lovande preklinisk data för FG001 som fototermisk behandling - Forskningsbolaget Fluoguide rapporterar att lovande preklinisk data för läkemedelskandidaten FG001 som fototermisk behandling av cancer har publicerats. Det framgår av ett pressmeddelande.
8/17/2021 10:45:34 AM - FluoGuide fortsätter till sjätte dosnivån med FG001 i fas I/II-studien - Forskningsbolaget Fluoguide har fått grönt ljus för att att fortskrida med nästa dosnivå av FG001 under den pågående kliniska fas 1/2-studien med patienter med höggradig glioma, aggressiv hjärncancer. Det framgår av ett pressmeddelande.
6/30/2021 8:19:32 AM - Fluoguide ingår avtal med Linköpings universitetssjukhus för fas 2-studie - Forskningsbolaget Fluoguide har nått en överenskommelse med enheten för neurokirurgi på Linköpings universitetssjukhus för fas 2 av den pågående kliniska studien med FG001 för patienter med höggradigt gliom. Det skriver bolaget i ett pressmeddelande.
6/17/2021 10:09:25 AM - Fluoguide: FG002 study shows FluoGuide is more than a one-product company - SEB - FluoGuide announced publication of preclinical studies of its new candidate, FG002, which is in development for fluorescence-guided surgery in colorectal cancer. The study shows that FG002 is highly potent and performs well in terms of several important metrics, as well as demonstrating that FlouGuide is more than just a one-product company. We view this as a positive, albeit early, further step forward.
6/17/2021 6:34:48 AM - Fluoguides prekliniska data har publicerats i vetenskaplig tidskrift - Uppmuntrande preklinisk data rörande forskningsbolaget Fluoguides projekt FG002 har publicerats i en vetenskaplig tidskrift. FG002 belyser upp den invasiva tillväxten av cancer och har därmed potential att förbättra canceroperationer.
5/27/2021 6:07:06 AM - Fluoguide: Progressing as planned - SEB - Following the Q1 numbers, we have only made minor adjustments to our estimates but leave our long-term assumptions unchanged. Our fair valuation range (SEK 108-140 per share) is unchanged. With plenty of milestone events lined up in 2021, and the recent clinical data boding well for the first phase clinical study results (expected in Q3/21), our view on Fluoguide remains intact.
5/26/2021 8:51:51 AM - Fluoguide Q1: No news is good news - SEB - FluoGuide reported Q1 EBIT of DKK -4.2m (vs. SEB at DKK -10.3m) and EPS of DKK -0.32 (vs. SEB at DKK -0.77). The key milestones for 2021 remains (1) results from the first phase clinical study (safety and selection of optimal dose) by Q3/21, (2) efficacy results from the second phase by Q4/21 as well as (3) initiation of a new prevalent indication for FG001. Nothing in the report that changes our view on the case.
5/26/2021 6:42:02 AM - Fluoguide redovisar som planerat ingen omsättning - Forskningsbolaget Fluoguide redovisar som planerat ingen omsättning under första kvartalet och små förändringar av sitt resultat.
5/20/2021 6:06:44 AM - Fluoguide: Countdown to phase 2 lift-off - SEB - With lead asset FG001 now being tested in evening dosing, we are approaching the end of the phase 1 portion of the trial and an important de-risking event in our valuation framework. Until now, there have been no safety signals to our knowledge, boding well for the final phase 1 topline. Following the directed share issue, we take our valuation range to SEK 108-140 (114-150).
5/18/2021 6:21:58 AM - Fluoguide får grönt ljus för nästa dosnivå med FG001 - Forskningsbolaget Fluoguide har fått grönt ljus för att att fortskrida med nästa dosnivå av FG001 under den pågående kliniska fas 1/2-studien med höggradig glioma. Det framgår av ett pressmeddelande.
5/12/2021 8:04:45 AM - Fluoguide får ge kvällsdoser av FG001 före operation - Forskningsbolaget Fluoguide har fått myndighetstillåtelse i Danmark om att få ge kvällsdoser av FG001 under pågående fas 1/2-tester med patienter som lider av höggradigt gliom. Det framgår av ett pressmeddelande.
5/12/2021 6:14:37 AM - Fluoguide: Fluo to raise SEK 75m in directed share issue - SEB - Management announced it is raising SEK 75m, or c. 6.6% of the market cap, to fund a phase 2 trial for lead product FG001 in new indications; to prepare for a possible phase 3 trial in 2022; for preclinical trials on FG002, which is likely to be directed at colorectal cancer; and for general corporate purposes.<br>
5/12/2021 5:59:56 AM - Fluoguide genomför riktad nyemission om 75 miljoner kronor till teckningskurs 95 kronor - Forskningsbolaget Fluoguide har nu genomfört den riktade nyemissionen om 75 miljoner kronor, som aviserades igår kväll, till en teckningskurs om 95 kronor. Det motsvarar en rabatt om nära 12 procent jämfört med gårdagens stängningskurs, framgår det av ett pressmeddelande.
5/12/2021 3:46:26 AM - Fluoguide planerar riktad nyemission på 75 miljoner kronor - Forskningsbolaget Fluoguide avser att göra en riktad nyemission på cirka 75 miljoner kronor, enligt ett pressmeddelande.
4/8/2021 12:49:40 PM - Fluoguide får grön ljus att fortsätta till femte dosnivån med FG001 - Forskningsbolaget Fluoguide får grönt ljus att fortsätta till den femte dosnivån i sin pågående kliniska fas 1/2-studie med FG001 för behandling av patienter med höggradigt gliom. Det framgår av ett pressmeddelande.
3/10/2021 8:04:56 AM - SEB höjer motiverat värde för Fluoguide till 114-150 kronor (83-110) - SEB höjer det motiverade värdet för forskningsbolaget Fluoguide till 114-150 kronor från 83-110 kronor. Det med anledning av att bolaget förvärvat de exklusiva rättigheterna till ett patent om att få använda FG001 vid fototermisk behandling.
3/10/2021 7:00:33 AM - Fluoguide: FG001 burns cancer and fuels high pricing - SEB - FluoGuide announced that it has acquired exclusive rights to a patent to use FG001 for photothermal therapy, an extension of photodynamic therapy that kills cancer cells with heat. The press release referenced strong preclinical data, and the application is important to justify our drug cost assumptions. The patent extends FluoGuide's IP to 2039 from 2034, materially extending peak sales and cash flows.
3/9/2021 1:08:33 PM - Fluoguide säkrar rättigheter för fototermisk behandling med FG001 - Forskningsbolaget Fluoguide har förvärvat de globala exklusiva rättigheterna att använda FG001 vid fototermisk behandling ihop med ljus. Det framgår av ett pressmeddelande.
2/25/2021 5:54:48 PM - Fluoguide: Change of listing venue - SEB - Based on changed listing venue, from 24 February onward, FluoGuide shares are traded on Nasdaq First North Growth Market Sweden (previously Spotlight Stock Market, Danish branch). As a result, the share price of FluoGuide is converted to SEK from previously DKK. Accordingly, our valuation range is updated to SEK 83-110 (from previously DKK 61-81) per share.
2/17/2021 1:56:51 PM - Fluoguide får grönt ljus att fortsätta till fjärde dosnivån med FG001 - Forskningsbolaget Fluoguide får grönt ljus att fortsätta till den fjärde dosnivån i sin pågående kliniska fas 1/2-studie med FG001 för behandling av patienter med höggradigt gliom. Det framgår av ett pressmeddelande.
2/15/2021 6:00:59 AM - Fluoguide har idag sista handelsdag på Spotlight före flytt till First North - Forskningsbolaget Fluoguide har idag den 15 februari sista handelsdag på Spotlight Stock Market före flytt till Nasdaq First North Growth Market där aktien kommer börja handlas den 24 februari.
2/8/2021 7:50:26 AM - Fluoguide flyttas till observationslistan inför börsflytt - Forskningsbolaget Fluoguide flyttas till observationslistan för att senare avnoteras från Spotlight. Sista handelsdag på Spotlight blir den 15 februari och bolaget kommer därefter att noteras på First North med första handelsdag den 24 februari, enligt ett pressmeddelande.
2/8/2021 5:58:54 AM - Fluoguide flyttar till First North - Forskningsbolaget Fluoguide har fått tummen upp på en ansökan om att lista aktien på Nasdaq First North.
2/3/2021 9:08:07 AM - Fluoguide vill flytta till First North och söker nya patent - Forskningsbolaget Fluoguide planerar att byta hemvist för bolagets aktie. Bolaget har ansökt om att notera aktien på Nasdaqs tillväxtlista First North och preliminär första handelsdag är satt till den 24 februari, enligt ett pressmeddelande.
1/27/2021 9:18:32 AM - 2020 var så bra som det hade kunnat bli för Fluoguide, motiverat aktievärde 61-81 kronor - SEB - Året 2020 var så bra som det hade kunnat bli för Fluoguide, skriver SEB i en uppdragsanalys med ett reviderat motiverat värdeintervall för aktien mellan 61 till 81 kronor (59-79).
1/27/2021 8:55:35 AM - Fluoguide: All’s well that ends well - SEB - 2020 was about as good a year as could have been hoped for FluoGuide, with a flawless start to its clinical development program for lead candidate FG001, including significant, if relatively modest, de-risking of the case. 2020 is set to be another major year for FluoGuide.
1/26/2021 9:15:52 AM - Fluoguide: Q4: FG001 development on track - SEB - FluoGuide reported Q4 earnings of DKK -8,5m, -20% vs. SEB at DKK -7.1m, for EPS of DKK -0.62 vs. SEB at DKK -0.53. Importantly, the clinical timeline is unchanged, with phase 1 readout in mid-2021, and phase 2 readout in H2-2021. Despite the faster than expected cash burn, given a DKK 4.7m tax credit and second stage of EU funding not in the current cash position, management estimates funding to be sufficient until March 2022, if the phase 3 trial does not go ahead sooner.
1/26/2021 7:54:53 AM - Fluoguide rapporterar en ökad rörelseförlust - Forskningsbolaget Fluoguide redovisar som väntat ingen omsättning i det fjärde kvartalet. Rörelseförlusten blev högre jämfört med samma period året innan.
1/13/2021 12:05:12 PM - Fluoguide: Green light to proceed to third dose level - SEB - Fluoguide announce green light to proceed to the third dose level in the ongoing ph I/II trial in patients with high grade glioma. The results from the second dose level are in line with data from the first dose level in respect to safety and tolerability and lights was detected in 100% of patients. The data provide further validation of FG001 mode-of-action but we will await the complete dataset from the dose-escalation phase of the trial before further de-risking the case.
1/13/2021 11:17:53 AM - Fluoguide får grönt ljus att fortsätta till tredje dosnivån med FG001 - Forskningsbolaget Fluoguide får grönt ljus att fortsätta till den tredje dosnivån med FG001 i sin pågående fas 1/2-studie inom höggradigt gliom (högmaligna). Det framgår av ett pressmeddelande.
1/8/2021 8:58:35 AM - Fluoguide: FIH data further elucidate equity story - SEB - Initial data validates FluoGuide’s near-infrared fluorescence approach<br>Although there is a long way to go, and significant uncertainty remains around safety/tolerability, utility in fluorescence-guided surgery, and ability to reduce cancer recurrence, it is difficult to overstate the significance of obtaining human data. The fact that any fluorescence was detectable at all at this dose (and with only two of three patients fluorescing, it seems likely that the signal was weak) speaks to the high signal-to-background ratio, an important initial validation of FluoGuide’s near-infrared fluorescence approach. We also note that, importantly, the blood-brain barrier in these two patients was not an impediment to penetrating CNS tissue for FG001, although we caution that it is well established that disruption of the BBB can occur in glioblastoma. At this point, we may have to await the complete dataset from the dose-escalation phase of the trial to further de-risk the case.
12/17/2020 2:55:33 PM - Fluoguide senaste besked ett uppmuntrande första besked - SEB - Forskningsbolaget Fluoguides senaste besked att de tillåts påbörja en andra dosökningfas i studie med FG0001 ses som ett uppmuntrande första besked av SEB. Det framgår av en uppdragsanalys.
12/17/2020 11:57:18 AM - Fluoguide får påbörja den andra dosökningfasen i fas I/II studien med FG001 - Forskningsbolaget Fluoguide har fått tillåtelse att påbörja den andra dosökningsnivån i den pågående fas I/II-studien med läkemedelskandidaten FG001 i patienter med höggradigt gliom. Det framgår av ett pressmeddelande.
12/1/2020 9:22:40 AM - SEB sätter motiverat värde 42-57 danska kronor på Fluoguide, FG001 har blockbusterpotential - Forskningsbolaget Fluoguide får ett motiverat värde på 42-57 danska kronor i en uppdragsanalys av SEB. Aktien handlas till drygt 61 danska kronor på tisdagen, vilket motsvarar en uppgång på nästan 12 procent.
12/1/2020 6:49:12 AM - Fluoguide får patentskydd för FG001 i Australien - Forskningsbolaget Fluoguide har säkrat patentskydd för FG001 i Australien som gäller fram till september 2035. Det framgår av ett pressmeddelande.
11/20/2020 7:19:15 AM - Fluoguide minskade rörelseförlusten i tredje kvartalet - Forskningsbolaget Fluoguide redovisar som väntat ingen omsättning under tredje kvartalet medan rörelseförlusten minskade.
11/9/2020 2:06:05 PM - Fluoguides första patient har inkluderats i dosökningfasen i fas I/II studien med FG 001 - Forskningsbolaget Fluoguide meddelar att den första patienten idag har inkluderats i dosökningsfasen i den kliniska prövningen av bolagets fas I/II studie med läkemedelskandidaten FG001 i patienter med med höggradigt gliom. Det framgår av ett pressmeddelande.
10/26/2020 8:15:43 AM - Fluoguide beviljas post doc-bidrag om 1,2 miljoner danska kronor för att expandera pipeline - Forskningsbolaget Fluoguide uppger att de erhållit ett bidrag om 1,2 miljoner danska kronor från Innovation Fund Danmark som ska finansiera en 3 årig post doc-position för Karina Juhl för att utveckla och expandera bolagets pipeline. Det framgår av ett pressmeddelande.
9/21/2020 7:51:32 AM - Fluoguide utser Henrik Moltke som ny finanschef - Forskningsbolaget Fluoguide uppger idag i ett pressmeddelande att Henrik Moltke utses som ny finanschef hos bolaget.
9/4/2020 5:15:29 AM - Fluoguide får tummen upp för viktig studie av danska myndigheter - Forskningsbolaget Fluoguide har fått tummen upp av de danska myndigheterna att få genomföra sin kliniska prövning i fas I/II.
8/14/2020 6:28:55 AM - Fluoguide rapporterar som förväntat inga intäkter i andra kvartalet - Forskningsbolaget Fluoguide redovisar som förväntat inga intäkter i andra kvartalet 2020. Bolaget rapporterar en ökad förlust jämfört med motsvarande kvartal i fjol.
8/13/2020 9:33:59 AM - Fluoguide i avtal med amerikanskt bolag - Forskningsbolaget Fluoguide har ingått ett avtal med det amerikanska bolaget LI-COR Biosciences om att utveckla och leverera produkter som ska användas inom onkologisk kirurgi.
1/30/2020 7:09:03 AM - Fluoguide genomför riktad emission – tar in 11,6 miljoner danska kronor – snabbar på processen - Fluoguide genomför riktad emission – tar in 11,6 miljoner danska kronor – snabbar på processen
4/8/2019 3:08:14 PM - SvD Börsplus neutrala till noteringen av Fluoguide - SvD Börsplus neutrala till noteringen av Fluoguide
3/29/2019 12:40:00 PM - Fluoguide genomför nyintroduktion på Spotlight - Fluoguide genomför nyintroduktion på Spotlight
3/11/2019 9:09:11 AM - Fluoguide väljer Sedermera FK som rådgivare inför planerad nyintroduktion på Spotlight - Fluoguide väljer Sedermera FK som rådgivare inför planerad nyintroduktion på Spotlight