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The next six months will be pivotal for Faron with the final data on dose level and frequency for BEX now expected around the turn of the year. This should enable a decision on pivotal clinical trial design and an end of phase 2 meeting with the FDA. The completion of the data package could also enable more conclusive partnering discussions for BEX. However, the cost of continuing development is high for Faron alone, particularly given current cash levels, making it a higher risk investment.
Faron Pharmaceuticals Oy
1H22: clinical progression for an exciting oncology asset The interims offer investors a glimpse of what Faron’s very promising oncology asset could deliver. Whilst there is clearly a funding requirement (to complete clinical trials), we cannot help but get excited by what Faron is currently seeing in its Phase I/II trials (MATINS). The latest data reveals a 100%, 12-month survival outcome for some patients that respond to bexmarilimab (and a promising diagnostic to predict which patients will respond) after these patients (eg in refractory melanoma) have exhausted all other treatment options. Non-responders (and by implication, those untreated) only achieve a 6% survival rate. Miles.Dixon@peelhunt.com
Interim results to June reported an increasing net loss as clinical trials on bexmarilimab accelerate. Survival and safety data continues to be encouraging, albeit we continue to await information on dose, frequency and design of the next step. The end of Phase I/II meeting with the FDA is now expected late 2022/early 2023. However, funding continues to be a concern.
Faron is expected to report interim results on the 25th August. We expect these to report rising losses as the bexmarilimab trials expand, however, despite the recent EUR5m fundraising cash continues to be a concern. We expect a focus on data to enable the end of Phase I/II meeting with the FDA and a further fundraising, both required to enable the company to draw down the next tranche of debt. Data to date continues encouraging but funding remains precarious. We update our forecasts to include the June private placement reducing our target price to 316p (previously 348p).
Impressive top line, one-year survival data in solid tumours This morning Faron announced top-line 12-month survival data for bexmarilimab across ten different, but all advanced, solid tumour types (from patient groups in its Phase I/II MATINS trial). We have been saying for some time that we believe Faron’s bexmarilimab asset is something investors should really look at, and these data this morning support that view. Patients groups with advanced solid tumours (having exhausted other treatment options and with very bleak prognoses) showed that 65% of those that responded to bexmarilimab treatment were alive after 12 months (vs only 11% that did not). Miles.Dixon@peelhunt.com
We update our estimates and target price following the FY results and the halting of the HIBISCUS trial. Faron results reiterated the progress made on bexmarilmab over the past year, this is now the primary value within Faron. Key data is due in Q3. We reduce our target price to 348p (previously 408p).
FY21s and a promising oncology asset you should look at Investors looking for exciting pipeline opportunities should look no further. FARN’s bexmarilimab alone is worth spending the time: this differentiated biologic on the oncology landscape is giving some early clinical data that should make large Pharma take notice. At 31 Dec 2021, cash was €6.9m (supplemented by a post-period debt funding facility of up to €30m), with loss for FY21 of €21.2m (vs PHe €20m). Cash is required but with some important clinical milestones upcoming and impressive Ph I/II data so far (response rates of 30-40% in last line cancer patients), investors should get up to speed ahead of clinical data outputs. Miles.Dixon@peelhunt.com
FY results to December show a Net Loss of EUR21.2m and YE cash of EUR6.9m as clinical trial activity increased in the year. Data readouts from both bexmarilimab and traumakine are expected over the next six months. We continue to see significant value in bexmarilimab, the data on dose and frequency due in H2 should clarify the next steps for development.
Faron FY results are due on the 25th March. We expect the company to report a rising Net Loss as clinical trial activity has ramped up over the past year; both bexmarilimab and traumakine, are due to reach important data readouts over the next six months. We expect a confirmation on timing at the results. The immediate funding requirement has been pushed to after this data is due through new debt financing from IPF Partners. We continue to see significant value in bexmarilimab, the data on dose and frequency due in H2 should clarify the next steps for development.
Faron has obtained up to EUR30m debt funding from IPF Partners, removing its immediate requirement for cash. However, beyond the first EUR10m the later debt is subject to conditions and, as with all biotech debt, the deal is relatively expensive. It also does not remove the potential for dilution for equity investors in the next 12 months. However, given data on bexmarilimab continues to look promising, we retain our BUY recommendation and 408p target price.
Faron’s R&D presentation gave clarity on next steps with bexmarilimab. We await key data on dose and frequency due in Q2/3, which should provide the information required for a meeting with the FDA. The incremental data is building to support the use of bexmarilmab in a wide range of patients, and the potential for use to extend utilization of checkpoint inhibitors provides a substantial market. Consequently, although timelines have been extended, and the funding requirement likely higher, the route to approval is clearer. We review our target price (reducing to 408p, previously 489p) to take into account the longer timelines, but retain our BUY.
An alternative to the immuno-oncology alphabet soup For investors looking for high growth in Healthcare, we are particularly enthused by Faron’s unique approach to modulating the immune system to help tackle cancer and COVID-19-like diseases. At a time when many of the ‘gene therapy’ ideas in oncology are merely ‘me too’ approaches, we think Faron offers an elegant alternative. Capital is required for commercialisation but clinical data (Phase I/II) so far is very promising – saving lives when all other treatments have failed – and Faron is starting to engage regulators to gain approval and broaden the patient groups that can benefit from these treatments. Miles.Dixon@peelhunt.com 60-page note
Biomarker data from the MATINS trial demonstrates both the profile of patients which may benefit from treatment with bexmarilimab, and also the ignition of an immune response in these patients. This is an important finding, and supports the mechanism of action of bexmarilmab. However, we still expect the FDA to require further data on dose and frequency to allow the commencement of pivotal trials. The company is funded until Q3 2023, with these key data points due before this date.
Faron is now funded until Q3 2022, sufficient to reach the next key data points; dose and frequency data for bexmarilimab and interim results of the Traumakine HIBISCUS trial. We update our estimates following interim results and the EUR10.5m fundraising, adjusting our target price to 489p to account for the dilution (prev 515p).
Faron has announced the presentation of the updated MATINS data at ESMO today. The data confirms the safety profile, and adds breast cancer to the indications in which bexmarilimab is shown to be effective, taking the number of tumour types in which a strong disease control rate is seen to five. Overall survival at six months was estimated at 83% for responding patients compared to 29% for non-responders. The data will also be discussed in a webinar for investors on September 21st.
Faron interim results were broadly in line with expectations. New data on bexmarilimab is expected to be presented at ESMO (mid-September) with the trial expected to expand to Part III in H2. Traumakine is also now progressing with the Phase II/III HIBISCUS trial now dosing in the US, with first data likely in Q1 2022. The next six months should bring significant news across both programmes, and likely a fundraising, as current cash, though sufficient for the current trials, is not enough for continued development of bexmarilimab. We retain our 515p price target and BUY recommendation.
Interim results to June are expected on 26th August, we expect further data on bexmarilimab, and improved visibility on next steps, in addition to an update on the progress of ethical approval for the Traumakine HIBISCUS trial in the US. We expect the company to have ended the period with Net Cash of EUR12m.
Faron hosted a KOL presentation with Maija Hollmén, adjunct professor of tumour immunology, University of Turku, Finland, discussing the background to Clever-1, the target for bexmarilmab and the potential for use in multiple indications. No new data was presented, we have to wait for later in Q3, but a timetable was provided showing the likely next steps. The drug has significant promise and the science behind the product is strong, but to move to pivotal trials requires confirmation of size and frequency of dosing, which remains a work in progress. We retain our BUY recommendation and 515p target price.
Faron (FARN.L): Data from Phase 1/2 MATINS trial – from yesterday | Arix Bioscience (ARIX.L): Antibiotic portfolio company narrowly misses endpoint in Phase 3 trial – from yesterday
Faron Pharmaceuticals Oy Arix Bioscience Plc
Faron Pharma (FARN.L): IND approval for Clevegen®
Faron Pharmaceuticals Oy ImmuPharma plc
Faron Pharma (FARN.L): Phase 2 interim results
Faron Pharmaceuticals Flash : Placing and subscription to raise up to £15m
Faron Pharmaceuticals Flash : Commercial progress continues as we await Phase III readout
Faron Pharmaceuticals Flash : European patent grant for Clevegen
Faron Pharmaceuticals : INTEREST-ing data due Q2; Reviewing target price
Faron Pharmaceuticals Flash : Traumakine receives FDA Fast Track
Faron Pharmaceuticals Flash : IND for Traumakine approved, progresses towards BLA
Faron Pharmaceuticals Flash : Recruitment complete; but data will be closer to mid-year
Faron Pharmaceuticals : Recruitment complete; but data will be closer to mid-year (11-Dec-2017)
Faron has raised £10m at 800p, putting it in a strong position to prepare for launch of Traumakine, assuming a positive result from its Phase III INTEREST trial. We continue to expect readout from this trial around the turn of the year. We update our target price to 717p (previously 723p) and maintain our BUY recommendation.
Traumakine has received Promising Innovative Medicine (PIM) designation from the MHRA. This potentially allows both faster access to the UK market and early pricing negotiation with NICE. Continuing encouraging progress which, in association with the recent positive progress with the FDA, highlights that pharmaceutical regulators are also aware of the need for a treatment for ARDS. We maintain our BUY recommendation.
We update our forecasts and target price following the interim results and the FDA confirmation that European data is sufficient for a BLA submission. This brings forward our estimate of a US launch to 2019 (previously late 2020). Faron is entering a critical 12 months, with Phase III data due at the turn of the year from both Europe and Japan, regulatory submissions, and the first clinical data from Clevegen. We reiterate our BUY recommendation and increase our target price to 723p (previously 663p).
Interim results to June were in line with our expectations. The key event for Faron remains the initial readout from the 300 patient INTEREST Phase III trial in ARDS where the company has confirmed completion of recruitment in Q4. Following the positive outcome of discussions with the FDA announced earlier this week, which should result in a faster and cheaper route to market in the region, the shares look increasingly attractive. We retain our BUY recommendation.
Faron has announced that the FDA will allow it to proceed directly to a Biologics License Application (BLA) submission for Traumakine, assuming a positive result from the ongoing INTEREST Phase III trial. We expect a more detailed update from Faron on its US strategy at the interim results on 6 th September. However, this proposal from the FDA will likely result in a faster and cheaper route to market in the US than currently forecast. We retain our BUY recommendation.
The interim results due on 6th September are unlikely to add anything significant to the investment thesis, with investors focused on the outcome of the Traumakine Phase III which we expect around the turn of the year. We expect an increased loss, due to the increased clinical activity, though the company remaining well-funded for current activities. We retain our BUY recommendation.
Faron has received a report from the fifth meeting of the IDMC which has recommended that the trial continues with no changes. No negative or positive read through on the likely outcome of the trial can be made from the statement. Faron anticipates that the recruitment target of 300 patients will be reached in the 4th quarter. We maintain our BUY recommendation.
Faron has received the expected report from the IDMC on 4th May which has recommended that the Traumakine Phase III trial continues with no changes. No negative or positive read through on the likely outcome of the trial can be made from the statement. The next review of the data is expected to be after recruitment of 240 patients, likely in Q3 2017. Given the recent performance of the shares we expect a fall back in price today, though retain our expectation of long-term performance.
Faron has announced that it has formally signed an agreement with the University of Birmingham Medical School to initiate a liver cancer program testing Clevegen in clinical trials. The announcement also confirms that the clinical trial application (CTA) is expected to be made to the MHRA in late 2017 or early 2018. Faron is entering a transformational period, with the Traumakine Phase III INTEREST trial expected to report in H2 2017 with the advanced advice due from the IDMC in May offering the potential for an earlier outcome. We maintain our BUY recommendation and 663p target price.
Faron is entering a transformational period, with the data from the Traumakine Phase III trial due in H2 and on track for EU launch in 2018. A review of our pricing assumptions results in a rise in our peak sales estimate for Traumakine to $1 billion, making Faron a very attractive investment. We maintain our BUY recommendation, update our forecasts and increase our TP to 663p (previously 404p).
Faron has reported FY results to December 2016 in line with expectations. The company is entering a transformational period, with the data from the Traumakine Phase III INTEREST trial expected over the next 6-9 months. Following the recent fundraising the company is in a strong position to maintain development momentum across both of its platforms. We maintain our BUY recommendation and expect to update our forecasts and target price post this morning’s results presentation.
Faron has enrolled the first patient into its Phase II RAAA trial, the follow up indication for Traumakine. We continue to expect the company to announce results from the Phase III ARDS trial for Traumakine in H2-2017. We reiterate our BUY recommendation and rolling forward our NPV increase our target price to 404p (previously 361p).
A comprehensive trading update indicates that Faron remains on track with the Traumakine Phase III trial in ARDS, and as expected has commenced a further Phase II trial with the drug in patients with ruptured acute abdominal aorta. In addition, ongoing progress with Clevegen indicates the program will reach the clinic in 2018. We reiterate our BUY recommendation and rolling forward our rNPV increase our target price to 404p (previously 361p).
Yesterday Panmure Gordon hosted an investor lunch with Professor Geoff Bellingan, the principle investigator of Faron’s Phase III trial for Traumakine. The discussions confirmed our confidence in both the need for a drug for treatment of ARDS and the strong competitive position of Traumakine. In addition, it highlighted the wider opportunity beyond this initial application. We reiterate our BUY recommendation and 361p price target.
Faron’s patent to protect a novel formulation of Interferon-beta for intravenous use has been accepted by the Finnish patent office. Once granted this patent is expected to extend IP protection on Traumakine until 2036-37. With a large orphan product in Phase III, due to report data in mid-2017, we see Faron as a very interesting late stage development opportunity for investors. We reiterate our BUY and 361p price target.
The first patient has been dosed in the Japanese Phase III for Traumakine. The 120 patient trial is expected to report in 2017/18 and will provide significant support to the result of the European 300 patient Phase III currently ongoing. The IDMC has recently confirmed continuation of the European trial with no modifications. We see Faron as a very interesting late stage development opportunity for investors and reiterate our BUY and 361p price target.
Faron has announced the admission of 3.2m additional shares to the LSE following the raising of £8m (£7.3m net) in a placing and subscription offer at the mid-market price. With the Traumakine Phase III clinical trial well underway we believe Faron is a very interesting late stage development opportunity for investors. We maintain our BUY recommendation and revise our target price to 361p to account for the dilution from the transaction.
We have updated our estimates following the H1 2016 results. The primary change is spreading the clinical expenditure for the Traumakine Phase III more evenly across the trial period to mid-2017. The results meeting highlighted significant positive progress for the lead drug, with the Japanese pivotal trial due to commence recruitment in H2 2016, and plans for a trial in a second indication (RAAA) underway. The Clevegen program also continues to expand. We maintain our BUY recommendation and 383p price target.
Interim results show the Traumakine Phase III trial continues to progress to plan with the trial expecting to report mid-2017. ODD has initially been refused in the US, management are appealing, though slightly disappointing and potentially slowing the route to the US market by 6 months, we do not see this as a significant set-back. Financially H1 2016 was better than expected with higher income and lower costs than forecast resulting in an improved cash position. We retain our BUY recommendation and 383p Target Price.
Faron is expected to report its interim results to June on 5th September. We expect the results to show a step up in R&D as the company has commenced its Phase III trial for Traumakine in ARDS; we expect management to confirm recruitment is on track for initial data in mid-2017. We maintain our estimates and BUY recommendation ahead of the results.
Faron has appointed Abzena to manufacture Clevegen, the second product in the Faron portfolio. Progress towards clinical trials is encouraging, although Clevegen remains upside to our valuation. A $2.6bn collaboration between Celgene and Jounce Therapeutics announced last week, on a similar technology, suggests the product could have significant value and that an early stage deal is possible. We retain our BUY recommendation and 383p price target.
Yesterday Faron management hosted an R&D day. The presentations highlighted the extremely strong fundamental science background to Faron and also the support that it gains from its Key Opinion Leaders. Our valuation remains based on the lead product Traumakine, for which Principle Investigator Professor Bellingan’s enthusiasm was palpable. The Clevegen opportunity was also clarified and with platform now described in discrete indications we believe the potential for an early partnership is more obvious. We retain our BUY recommendation and 383p price target.
Faron has licensed rights to its lead product Traumakine to Pharmbio for development and commercialisation in Korea. Traumakine is an orphan drug in Phase III for treatment of ARDS which could be approved in Europe by the end of 2017. We believe Tramakine has the potential for peak sales of over USD 600m. The large market opportunity, short time to market and low risk development make this an attractive investment, in our view. We reiterate our BUY recommendation and a 383p target price.
Faron's lead product Traumakine, is an orphan drug in Phase III for treatment of ARDS which could be approved in Europe by the end of 2017. The Phase I/II trial showed a dramatic reduction in mortality, and we estimate peak sales for Traumakine at over USD 600m. The large market opportunity, short time to market and low risk development make this an attractive investment, in our view. We initiate coverage with a BUY recommendation and a 383p target price.
