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Aandeel Affimed NV OTC:AFMD.Q, NL0015001ZQ0

  • 5,160 19 apr 2024 21:57
  • +0,090 (+1,78%) Dagrange 5,000 - 5,210
  • 63.710 Gem. (3M) 418,8K

Forum Affimed geopend

5.633 Posts
Pagina: «« 1 ... 12 13 14 15 16 ... 282 »» | Laatste | Omlaag ↓
  5. Wil Helmus 25 oktober 2019 08:13
    Affimed: Updates To Thesis, Meaningful Catalysts In 2020

    Summary
    Shares have risen by over 50% since my initial recommendation and have lost over half their value since my latest update.

    I provide a brief recap of the bullish thesis, management presentations, and recent developments.

    Playing devil's advocate, the cause of current weakness could be the lack of meaningful near-term catalysts and slow progress in the clinic.

    Proof of concept has been established for AFM13, and there is a clear pathway to market with important data sets due next year. AFM24 is targeting a very large opportunity.

    Affimed remains a Buy, albeit more appropriate for investors with patience and long-term time frame.

    seekingalpha.com/article/4298880-affi...
  6. Wil Helmus 25 oktober 2019 08:18
    Maar even de hele tekst:

    Shares of German biotech firm Affimed (NASDAQ:AFMD) have risen by over 50% since my February 2018 article suggested that promising early-stage data would trump slow progress in the clinic. On the other hand, shares have lost over half their value since my August update piece.

    A number of new developments made me want to revisit this one, including submission of IND application for AFM24 (bispecific EGFR/CD16A innate cell engager for solid tumors) and FDA clearance for the IND for the AFM13/cord blood-derived allogeneic NK cell combination trial. My initial thought is that despite lack of participation in the recent bounce for the biotech sector, shares are offering investors an ideal entry point ahead of 2020 milestones.

    When looking at charts, clarity often comes from taking a look at distinct time frames in order to determine important technical levels to get a feel for what's going on. In the above chart (daily advanced), we can see the stock lose ground as updated data sets for its lead program failed to excite Wall Street. Shares experienced a temporary bounce after news of progress with the pipeline in September, but then just as quickly fell back to the multi-bottom established in the mid-2s. Weak price action even as the sector rebounds is not encouraging, as there's certainly a lack of interest from the buyers.

    Overview
    In my 2018 update piece, I touched on the following keys to the bullish thesis:

    Initial promising data for NK cell engager AFM13 provided us the element of derisking we look for, with efficacy observed in two studies as both a monotherapy in CD30-positive lymphoma and in combination with anti-PD-1 treatment Keytruda in patients with relapsed/refractory Hodgkin's Lymphoma. In the combination setting (with all the usual caveats for a low number of patients), 8 of 9 subjects (89%) treated at the highest dose showed an objective response rate (ORR), including 44% with complete metabolic responses and 44% with partial metabolic responses. To put this into context, historical ORR for Keytruda is in the range of 59-63% (a very favorable contrast). Likewise, the complete response rate of 44% also compares very favorably to figures obtained from prior anti-PD1 studies (9-22%). Additionally, these subjects had already undergone autologous stem cell transplant (or were not eligible) and had progressed after treatment with Seattle Genetics' (NASDAQ:SGEN) Adcetris. As a monotherapy in relapsed/refractory CD30-positive cutaneous lymphoma, in the first cohort (1.5mg/kg in 3 patients), ORR was 66% with one complete response, one partial response and one patient with stable disease.
    Several green flags were pointed out, including the hiring of Dr. Wolfgang Fischer as COO late last year (prior Head of Program and Project Management of Novartis' (NVS) Sandoz Pharmaceuticals) and the retained 18.5% ownership of Amphivena (developing CD-33 targeting T cell engager AMV564 in phase 1 studies for r/r AML and MDS).
    Lastly, I stated that the firm's tetravalent bispecific antibody formats offered significant differentiation from the competition, that claims of increased potency should be taken seriously, and that there was a strong rationale for developing follow-up candidates AFM24 and AFM26 as seen in preclinical data.
    The August pact inked with Roche (OTCQX:RHHBY) member Genentech added another layer of derisking and credibility to this story, as the large pharmaceutical company sought out the smaller firm to apply its ROCK platform to discover and develop innate immune cell engager-based immunotherapies (includes Affimed-generated product candidates, in addition to several undisclosed hematologic and solid tumor targets). Financial terms were impressive considering the small size of Affimed, receiving $96 million in upfront (and near-term) funding plus being set to receive up to $5 billion in milestone payments (includes regulatory, commercial and royalty). Digging deeper into the related SEC filing, only about $250 million of that $5 billion is linked to development activities and $1.1 billion is tied to regulatory approvals.

    Figure 2: Pipeline (Source: corporate presentation)

    I would be remiss if I forgot to mention my thoughts on the company's R&D presentation last year, published for ROTY members at the time. Despite being a bit dated, I believe they are still relevant and worth highlighting:

    CEO Adi Hoess did a great job of explaining the implications of positive data for AFM13 and how it bodes well for other programs generated with the same technology. "Our intention is to give back to patients the innate ability to combat cancer" was a very lofty statement with broad implications that stuck out to me.
    For lead program AFM13, Hoess pointed out that as checkpoint inhibitors, Adcetris and other therapies move up the line to earlier indications (i.e. in Hodgkin's Lymphoma, CTCL, etc.), opportunities are being created for AFM13 to fill in the void. This provided a stark contrast to the bear thesis that the market is satisfied with enough options or that opportunities targeted are too small.
    ASH data was compelling, clearly demonstrating benefit in PD-1 combination (Hoess painted the picture of being in a room of 100 patients and telling 20 of them they get to live 18 months or telling 44 they get to live 18 months). In response to analyst questions, Adi Hoess stated partnership discussions are ongoing but the company intends to retain AFM13 rights (i.e. co-development).
    As for efforts involving infused cord NK cells, it was noted that in 2 clinical studies in conjunction with high dose chemotherapy, NK cells lasted for up to 4 weeks, safety was great ("no side effects whatsoever") and relapse for these high risk multiple myeloma and DBCLC patients "was far superior than relapses for high dose chemo alone". In the DBCLC study, of 6 patients treated, none had relapsed, and little in the way of side effects had been observed. The idea in the first half of 2019 was to evaluate AFM13 in combination with anti-PD-1/PD-L1 antibody agent and adoptive NK cell transfer.
    As for partnering or the potential to do another transformational deal involving the ROCK platform, Hoess stated that the company's unique understanding of innate and adaptive immunity activation could lead to more selective deals and that they are having multiple dialogues with potential partners.
    In terms of the cash position and cash burn, Hoess stated that pro forma cash was $140 million providing for an operational runway into 2021.
    From there, I also provided a summary and my thoughts on management's presentation at JP Morgan Healthcare Conference to start off 2019. Again, these are worth revisiting as it's always important to make mental notes as to whether management is executing on stated objectives and prior timelines that they projected.

    The company had 4 ongoing clinical trials and for the first time ever was taking a phase 1 asset into phase 2 trial with registrational intent. There were plans for 3 new studies in the very near term. The company´s overall goal is to give back to patients their innate ability to fight cancer. A differentiating point is that the company is the only one that has clinically validated innate cell engagers.
  7. Wil Helmus 25 oktober 2019 08:18
    Figure 4: Market opportunities for AFM13 are modest but meaningful for a company of this size (Source: corporate presentation)

    Pro forma cash position was $139 million which could take the company into 2021 (not expecting dilution this year).
    ROCK platform represents a new approach to countering tumor immune evasion. Two distinct mechanisms are accessed, direct tumor cell killing (cytotoxicity) and phagocytosis (impact on killing and antigen presentation leading to overall immune response). The company uses tetravalent bispecific molecules (2 binding sites to innate immune cell and 2 binding sites to cancer cells), achieving high activity through high affinity and high specificity (very unique approach). ROCK platform allows for many different structures, molecules can be tailored to specific indications.
    While innate immunity can also be unlocked with monoclonal antibodies, the company believes there is no strong innate immune cell activation for most monoclonal antibodies. Generated clinical data also backs this up.
    As for the Genentech partnership, Hoess emphasizes how the pharma giant has vast expertise in immuno-therapy and antibody engineering, but still approached the smaller company for its expertise in innate cell engagers (key validation of platform and its potential for developing medicines with better response). In addition to $96 million upfront (already received), milestones of about $5 billion plus royalties await. The partnership allowed the company to maintain control of lead molecules (didn't sacrifice economics here).
    As for AFM13 in T cell lymphoma, in 9 patients, 4 showed response, so response rate of 45%. 4 out of other 5 patients have stable disease. Importantly, responses are deepening (patients treated with 2-8 week cycles and have observed stable disease being converted into partial responses).
    As for AFM13 in combination with Keytruda in Hodgkin's Lymphoma, in 24 patients at highest dose 88% ORR and 42% to 46% CR rate (doubling versus Keytruda). Again, deepening of response observed and 6-month PFS is 77%. Thus, AFM13 is active in monotherapy and in combination with checkpoint inhibitor, activating innate immune system is resulting in more CRs.
    As for getting AFM13 to market, a registrational study is planned for PTCL (as monotherapy) with potential for accelerated approval. The company is currently evaluating Hodgkin's Lymphoma combination PD-1 with AFM13 and pending discussion with FDA will disclose the plan for moving forward.
    The approach of combining AFM13 with cord blood derived NK cells makes sense on several levels as the number of NK cells matter (contributes to having response or deeper response). Several academic institutions have pursued this approach by providing NK cells, and MD Anderson preclinical data shows in vivo improvement in efficacy. This has implications for any CD30+ lymphoma and thus another study pursuing this approach in humans is planned.
    As for AFM24 in EGFR, the program looks derisked to a degree considering that the target is highly validated via current therapies (however, they are limited by toxicities, acquired resistance and limited antitumor immune response). Affimed hopes to develop a safer therapy which activates innate immune cells and thus is more potent/has greater efficacy (this is already observed in in vivo data).

    Figure 5: Aggregate market opportunity for AFM24 is quite large and thus initial data for this program will be a meaningful catalyst (Source: corporate presentation)

    Recent Update and Other Information
    In mid-October, the company provided a much needed update on the progress of its pipeline, as it was and is obvious that investors and Wall Street are getting fed up with apparently slow movement in the clinic. For AFM24, IND has been filed to initiate first-in-human phase 1/2a trial with the objective of finding the maximum tolerated dose and recommended phase 2 dose (as well as the usual endpoints of safety, PK, PD, signs of early efficacy, etc.). Patients enrolled will have advanced cancers known to express the epidermal growth factor receptor, EGFR. The company also announced that the FDA gave the green light to IND application for a phase 1 study evaluating AFM13 with pre-mixed cord blood-derived allogeneic NK cells to treat patients with relapsed/refractory CD30-positive lymphoid malignancies. In addition, the registration-directed study of AFM13 as monotherapy in relapsed/refractory peripheral T cell lymphoma (pTCL), continues on track to initiate this year.

    For the second quarter of 2019, the company reported cash and equivalents of €87.7 million as compared to net loss of €10.3 million (guiding for operational runway into 2021). Research and development expenses rose to €11.5 million, while G&A came in at €2.3 million.

    As for upcoming catalysts, interim efficacy looking at pivotal studies of AFM13 (mid to late 2020) appears to be the main catalyst to look forward to in the medium term. As noted prior, the company has the capacity to do additional deals in a similar fashion to the Genentech pact (could come at any time).

    Final Thoughts
    To conclude, the company continues to offer investors an intriguing value proposition as their unique platform technology with proof of concept established for lead program is valued at only $90 million or so when cash is backed out. Affimed's ROCK platform was also validated by its big pharma partnership, as Genentech sought Affimed out for its expertise in innate cell engagers. The key issue here holding the stock back is slow progress in the clinic, but I'd note that at least development plans in place for AFM13 and AFM24 are both logical and relatively efficient. Hopefully, management can operate in a more timely manner here than in the past, with the key upcoming test being whether interim efficacy looks at AFM13 are accomplished in the aforementioned time frame.

    For readers who are interested in the story and have done their due diligence, Affimed is a Buy, and I suggest patiently accumulating dips over the next couple quarters. However, this one seems more appropriate for investors with long term, multi-year time frame.

    Risks include slow progress in the clinic, setbacks including delays in timelines presented of management (would lead to even more crisis of confidence in leadership), disappointing data readouts and dilution at some point in 2020 considering current cash position and burn rate. Management really needs to execute in the clinic, as recently pushed back timelines, however slight, have punished the share price. In the first half of 2020, they'd do well to continue highlighting the immense potential of AFM24 and guide for when we can expect initial results.

    For our purposes in ROTY, I plan to revisit in Q1 2020 or so for potential inclusion in JF's Scorecard (active ideas that could be chosen for our model account due to presenting compelling catalyst or revaluation opportunities).
  9. Wil Helmus 25 oktober 2019 12:08
    Ik heb de tijd. Ze hebben met AFM13 en AFM24 een paar blockbusters in huis. Het ziet er naar uit dat de wetenschap erachter werkt. Dan zal het zich vanzelf uitbetalen in de vorm van (veel) hogere koersen. En met de Genentech deal, is er voorlopig genoeg geld in huis. Uit het SA stuk maak ik verder op dat ze in onderhandeling zijn met meerdere partijen:

    As for partnering or the potential to do another transformational deal involving the ROCK platform, Hoess stated that the company's unique understanding of innate and adaptive immunity activation could lead to more selective deals and that they are having multiple dialogues with potential partners.

    Ik blijf mooi zitten!
  11. forum rang 6 Hulskof 28 oktober 2019 10:37
    Ik las deze reactie op SA: CD16/CD30 clinical profile is not attractive, just wasting time and money.
    Only program which may have eventually value is NK targeting, but ... it may become obsolete by NK based CARs.

    Zit hier wat in? Ik ben inhoudelijk onvoldoende onderlegd om een goede mening te kunnen vormen...
  12. Wil Helmus 28 oktober 2019 11:34
    quote:

    Hulskof schreef op 28 oktober 2019 10:37:

    Ik las deze reactie op SA: CD16/CD30 clinical profile is not attractive, just wasting time and money.
    Only program which may have eventually value is NK targeting, but ... it may become obsolete by NK based CARs.

    Zit hier wat in? Ik ben inhoudelijk onvoldoende onderlegd om een goede mening te kunnen vormen...
    Ik ben inhoudelijk ook niet zo sterk, maar het feit dat AFM13 de effectiviteit van Keytruda, een kaskraker van Merck met een jaarlijkse omzet van 10 miljard dollar, verdubbelt bij Hodgkin-lymfoom lijkt mij zeer waardevol. Verder ga ik ervan uit dat Genentech geen tientallen miljoenen investeert in AFM26 als het er niet goed uit zou zien
  14. Wil Helmus 30 oktober 2019 17:55
    Interessante gedachte gepikt van het SA forum:
    I find it interesting that there’s been no mention of future plans for AFM13 in combination with Keytruda??? Early clinical studies have been very promising. Perhaps there’s a reason for the silence? I’m speculating, but would not be surprised if a partnership with Merck is brewing behind the curtain?
  15. forum rang 6 Tom3 31 oktober 2019 21:35
    quote:

    Wil Helmus schreef op 30 oktober 2019 17:55:

    Interessante gedachte gepikt van het SA forum:
    I find it interesting that there’s been no mention of future plans for AFM13 in combination with Keytruda??? Early clinical studies have been very promising. Perhaps there’s a reason for the silence? I’m speculating, but would not be surprised if a partnership with Merck is brewing behind the curtain?

    Was dat uit een Merck SA artikel? Het fonds was vandaag in NY anders wel (verdacht?) in trek. Wellicht hebben de yanks de daad bij het woord gevoegd.

    Zelf ben ik ook wel van overtuigd dat Dr Hoess druk aan het onderhandelen is. De deal met Roche is in alle stilte tot stand gekomen, hij kan het dus als de beste. Ik sluit niet uit dat Roche weer met hem om tafel zit. Vandaag hebben ze (Roche dus) een deal met Dicerna op RNAi gebied bekend gemaakt ( nadat ze eerst dit hele vakgebied hadden overgedaan aan de huidige leider op dat gebied: Arrowhead). Hoe dom kun je zijn. Nu moeten ze genoegen nemen met de #3. Affimed stelt hen echt in staat Keytruda/ Merck op den duur te overtreffen, Roche met haar Tecentriq kan wel wel weer een winnaar gebruiken.
  18. forum rang 6 Tom3 6 november 2019 18:02
    quote:

    Wil Helmus schreef op 6 november 2019 16:09:

    Fate Therapeutics maakt even een flinke duik. Ik zie een koersdoelverlaging van Wells Fargo voorbij komen. Is dat de reden voor deze ferme daling of is er meer aan de hand?
    Wells Fargo was nota bene 1 van de emissiebanken die in september j.l. het aandeel vrolijk verkocht hebben voor $ 17,50 per stuk. Je kunt nu $ 4 goedkoper, stelletje boeven. Ik heb bijgekocht. Naar mijn idee is er weinig aan de hand, het wachten is nu op de proof of concept. In verhouding tot Affimed is het aandeel nog steeds aardig veel duurder.
  19. Wil Helmus 6 november 2019 19:27
    Meer kans op vertragingen en complicaties volgens Wells Fargo:

    Wells Fargo downgrades Fate Therapeutics, cuts target to $16 from $24 Wells Fargo analyst Jim Birchenough downgraded Fate Therapeutics to Market Perform from Outperform with a price target of $16, down from $24. Following the company's Q3 update, the analyst believes it development path makes assessment of efficacy more difficult and could extend and complicate timelines to approval. The decision to prioritize combination therapy trials for FT500, FT516 and FT596 before fully assessing monotherapy activity "may take away clearer nearer catalysts and make interpretation of relative benefit more difficult," Birchenough tells investors in a research note. In the near term, he does not expect Fate's monotherapy efforts to yield meaningful efficacy.

    Read more at: 
    thefly.com/landingPageNews.php?id=298...
5.633 Posts
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