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Wells Fargo Says
Affimed is an immune-oncology researcher in the biopharma world, looking into new therapies for cancer patients. The company’s ‘redirected optimized cell killing’ (ROCK) platform is used to develop innate cell engagers capable of reactivating the patient’s own immune cells to combat tumors. The company has 6 separate programs in its development pipeline, most in the preclinical stage of research. The company’s focus is on the treatment of hematological and solid tumors.
Of Affimed’s drug candidates, AFM13 is the first to have reached the clinical trial stage. The candidate has trials ongoing for the treatment of peripheral T cell lymphoma and CD30-postive T cell lymphoma, as well as transformed mycosis fungoides. Other lines of research are in earlier phases of development. AMF13 is a CD16A-based innate cell engager, and has shown promise of some therapeutic efficacy as well as a favorable safety profile.
In March, Affimed announced that it will be continuing REDIRECT, a Phase 2 study of AFM13 as a treatment for CD30-postivie T cell lymphoma. So far, the study has shown some anti-tumor response in both Cohort A and Cohort B of the patient base. Affimed’s recent program update also showed significant progress with AFM24, the company’s second most advanced program, now in a Phase 1 trial of its efficacy against solid tumors.
In his report on Affimed for Well Fargo, analyst Nick Abbott gives the stock an Overweight (i.e. Buy) rating and a $18 price target that indicates a potential for 62% upside in the year ahead.
Backing his stance, Abbott writes, “Our Overweight rating on AFMD reflects our view on AFMD’s approach to immuno-oncology (IO) with focus on the ROCK platform of innate cell engaging bispecific antibody development as a monotherapy, in combination with checkpoint inhibitors and in combination with cell therapy. Positive interim analysis of the registration-directed REDIRECT trial of AFM13 provides validation of the ROCK platform, in our view.”
Wall Street’s analysts are unanimous here, giving the stock 5 positive reviews in recent weeks for a Strong Buy consensus rating. The shares are priced at $10.42 and their $14 average target implies ~25% one-year upside.
https://www.tipranks.com/news/article/wells-fargo-says-these-2-stocks-could-spike-over-60-from-current-levels
* * $AFMD Video Chart 04-09-2021 * *
Link to Video - click here to watch the technical chart video
Here's Why Shares of Affimed Skyrocketed Today
https://www.fool.com/investing/2021/04/09/heres-why-shares-of-affimed-skyrocketed-today/?source=iedfolrf0000001
AACR: Germany's small NK cell player Affimed makes a big splash with early lymphoma data
https://endpts.com/aacr-germanys-small-nk-cell-player-affimed-makes-a-big-splash-with-early-lymphoma-data/
Heavy volume; investors are forward looking!
Affimed shares rise 9% on positive data from NK cells + AFM13 in solid tumors
The company will host a conference call/webcast on April 14 at 4:05 p.m. E.T.
Affimed Initiated at Outperform by Credit Suisse
Price Target Announced at $15.00/Share by Credit Suisse
Excellent news! > Investors are forward looking!
Affimed Sees Positive Initial Data in Lymphoma Treatment Trial
8:08 am ET April 9, 2021 (Dow Jones) Print
By Robb M. Stewart
Affimed NV said it has seen positive initial clinical data from a trial of an approach developed to treat patients with a form of lymphoma.
All four patients in the Phase 1 trial experienced significant disease reduction, with two complete responses and two partial responses, with an objective response rate of 100%, the immuno-oncology company said Friday. There were no observed events of cytokine release syndrome, neurotoxicity syndrome or graft-versus-host disease, it added,
News of the early data sparked a rally in Affimed's shares, pushing them up 28% in premarket trading after closing at $7.89 Thursday, up 36% so far this year.
The trial is looking at cord-blood-derived natural killer cells precomplexed with innate cell engager AFM13 in patients with recurrent or refractory CD30-positive lymphomas. It is an investigator-sponsored study at the University of Texas MD Anderson Cancer Center
"These initial results indicate AFM13 may have the potential to help NK cells target and destroy cancer cells," said Andreas Harstrick, chief medical officer of Affimed. "We plan to continue to develop and customize approaches that leverage the unique and differentiating features of our ICE molecules in combination with adoptive NK cell transfer to provide options for treating a variety of hematologic and solid tumors."
The company said its study is continuing enrollment of the second dose cohort.
Write to Robb M. Stewart at robb.stewart@wsj.com
(END) Dow Jones Newswires
Book value $0.63 huge triple digit negative profit margins and cash flow. Only phase 1 just the beginning. Will have to hemorrhage money till completion. imho
Profitability
Profit Margin -175.03%
Operating Margin (ttm) -157.41%
Management Effectiveness
Return on Assets (ttm) -22.94%
Return on Equity (ttm) -114.04%
Income Statement
Revenue (ttm) 26.78M
Revenue Per Share (ttm) 0.34
EBITDA -41.33M
Net Income Avi to Common (ttm) -46.87M
Diluted EPS (ttm) -0.60
Balance Sheet
Total Cash Per Share (mrq) 1.31
Total Debt (mrq) 2.83M
Book Value Per Share (mrq) 0.63
Cash Flow Statement
Operating Cash Flow (ttm) -39.85M
Levered Free Cash Flow (ttm) -3.29M
$AFMD is screaming for the top after the company announced positive data from a clinical study of AFM13 in lymphoma. https://cnafinance.com/affimed-afmd-stock-rockets-on-data/
Wells Fargo Biotech Cell and Gene Therapy Companion o Newsletter. This week's themes include: continued fund-raising for cell and gene therapy; regulatory actions including first BCMA CAR-T product approval, a first CAR-T filing for adult acute lymphoblastic leukemia, IND approval for pre-loaded NK cells, Orphan Drug designation in TTR-amyloidosis; optimization of cell therapy including point-of-care, reversal of exhaustion; further exoneration of AVV as a driver of cancer, but caution over long-term toxicity from AAV9-SMN in mice with spinal muscular atrophy; funding of an academic CRISPR trial in sickle cell disease and pre-clinical data for a gene therapy addressing hemophilia A & B.
Highlights of the week include: 1) Applied Genetic Technologies Corporation (AGTC) partner, Bionic Sight disclosing positive data for BS01 in retinitis pigmentosa. 2) Emergence of potential point-of-care cell therapy competitor, Avalon GloboCare - relevant for Precigen (PEGN) and Ziopharm (ZIOP). 3) Gracell Biotechnologies (GRCL) agreement with Lonza to manufacture dual CD19/BCMA FasCAR-T, GC-012F.4) Announcement by uniQure (QURE) that independent investigation finds it highly unlikely that the case of hepatocellular carcinoma was caused by AAV. 5) Publication with senior author Guangping Gao that natural AAV sequences in tumors and adjacent tissue are not different from each other - relevant for QURE and Sangamo Therapeutics (SGMO). 6) IND approval for Affimed's (AFMD) first IND for pre-loaded NK cell therapy. 7) Autolus Therapeutic's (AUTL) obe-cel received PRIME designation for relapsed/refractory acute lymphoblastic leukemia (ALL). (8) Filing of an sBLA by Gilead for TECARTUS in adult ALL highlights obe-cel's superior safety profile. 9) FDA approved bluebird bio (BLUE) and BMY's BCMA CAR-T, ABECMA in a more restricted patient population than studied - relevant for AUTL, Cellectis (CLLS), Celyad Oncology (CYAD), Fate Therapeutics (FATE), GRCL. 9) Intellia Therapeutics (NTLA) received Orphan Drug designation in Europe for NTLA-2001 in TTR-amyloidosis. 10) CIRM will fund a CRISPR gene therapy trial in sickle cell disease at 3 University of California institutions - relevant for Beam Therapeutics (BEAM), BLUE, CRISPR Therapeutics (CRSP) & SGMO. 11) UCLA publishes pre-clinical data supporting clinical development of CD4 CAR-T for HIV; NIH publishes less encouraging data [this is science]. 12) Clinical vignette from Chinese glioblastoma patient treated with a B7H3 CAR-T published - relevant for FATE. 13) Columbia University publish pre-clinical data suggesting gain of toxic function data in mice receiving AAV9 SMN treatment for spinal muscular atrophy - relevant for Ionis Pharmaceuticals (IONS) if there is read through to NVS's ZOLGENSMA. 14) Pre-clinical gene therapy with a platelet restricted factor Xa is effective in hemophilia A & B - relevant to QURE/SGMO. 15) CAR-T exhaustion can be reversed in pre-clinical models with a single dose of dasatinib - relevant for all companies developing CAR-T using a high affinity/avidity scFv.
Notable Corporate Events
AGTC partner Bionic Sight reported initial data from a phase 1/2 study of BS01 in advanced stage retinitis pigmentosa (RP). The data demonstrated that all four patients, who were complete or near-completely blind, can now see light and motion. Additionally, 2/4 patients can now detect the direction of motion. Bionic expects to report additional data later in 2021. Recall, AGTC has the option to pick up the program when the phase 1/2 data are available.
Avalon GloboCare Corp and strategic partner Arbele, are collaborating with the University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center to advance the clinical development of point of care RNA-based autologous cell therapies using FLASH CAR technology. Avalon’s first FLASH CAR product candidate, AVA-011 targets CD19 and CD22 is on track to initiate a clinical study in B-cell leukemia and non-Hodgkin’s lymphoma – relevant for PEGN and ZIOP who use on-site point of care CAR-T manufacture leveraging Sleeping Beauty. PEGN and ZIOP use conventional DNA-CARs which integrate into the T cell genome while Avalon is using an RNA CAR which may be episomal and shorter lived.
GRCL signed an agreement with Lonza to manufacture FasTCAR products to support IND filing of dual BCMA/CD19 FasTCAR, GC-012F. Separately, GRCL announced enrollment of the first acute lymphoblastic leukemia patient into the registration-directed trial of GC007g in China. GC007g is an HLA-matched donor-derived allogeneic CD19 CAR-T product.
QURE announced the results of an independent investigation into the case of hepatocellular carcinoma (HCC) diagnosed in a patient in the HOPE-B trial. QURE noted that the independent investigation found it highly unlikely the HCC was caused by the company's AAV gene therapy etranacogene dezaparvovec (etra-dez).
Notable Regulatory/Clinical News
AFMD and partner NKMax America announced FDA IND clearance for a co-sponsored phase 1/2a dose escalation and expansion study evaluating AFMD’s EGFR/CD16A innate cell engager AFM24 in combination with NKMax America’s autologous NK-cell product SNK-01, currently in phase 1 testing, in patients with advanced/metastatic EGFR-expressing solid tumors.
AUTL announced receipt of PRIME designation for Obe-cel (AUTO1) in relapsed/refractory B-acute lymphoblastic leukemia (B-ALL) as well as recent listing of the MCARTY trial (NCT04795882) evaluating a modular CAR-T targeting BCMA alone or BCMA with CD19.
AUTL – Filing of an sBLA by GILD for TECARTUS highlights the superior safety profile of obe-cel (AUTO-1). With 1/4 and nearly 1/2 of TECARTUS-treated adult acute lymphoblastic leukemia patients suffering grade 3 or higher cytokine release syndrome (CRS) and neurotoxicity / immune cell associated neurotoxicity syndrome (ICANS) respectively at the 1M cell dose of ZUMA-3. By contrast, in 20 patients treated with obe-cel, AUTL reported no grade 3 or higher CRS and ICANS was limited to 4/20 patients, of which 3 cases were grade 1 and resolved within 24 hours.
AUTL – Chinese academics listed a phase 1 trial of a TRBC1 CAR-T in TRBC1+ve relapsed/refractory T cell leukemia. AUTL is conducting the LIbrA T1 trial of AUTO4 in TRBC1+ve T cell leukemia with interim data expected 2H21; AUTL expects to initiate clinical development of AUTO5 in TRBC2 T cell leukemia 2H21.
AUTL/CLLS/CYAD/ FATE & GRCL - we see the approved label for bluebird bio/ Bristol Myers Squibb's BCMA CAR-T, ABECMA for relapsed/refractory multiple myeloma setting a low bar for competitors. While ABECMA was studied in 4th line plus myeloma FDA gave the product a 5th line plus label. ABECMA’s blackbox warning includes hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) which occurred in 4% of patients overall increasing to 8% at the 450MM dose; approved CD19 CAR-T do not have an HLH/MAS blackbox warnings. In more recent BCMA trials, we note use of the IL-1 receptor antagonist, ANKINRA, potentially for HLH/MAS with 19% use in JNJ/Legend Biotech's cilta-cel CARTITUDE-I trial.
NTLA announced receipt of orphan drug designation from European Commission (EC) for Regeneron-partnered in vivo editing program NTLA-2001 for TTR amyloidosis (ATTR). The decision follows the initiation of the phase 1 study of NTLA-2001 in hereditary ATTR with polyneuropathy (hATTR-PN).
BEAM/BLUE/CRSP/EDIT - California Institute of Regenerative Medicine will support a phase 1 trial of CRISPR engineered SCD gene therapy to be conducted at The University of California, San Francisco (UCSF), UC Berkeley (UCB) and UC Los Angeles (UCLA).The 4-year study will include six adults and three adolescents with severe sickle cell disease. It is planned to begin this summer in Oakland and Los Angeles.
Notable Peer Reviewed Publications
FATE/CLLS – With both companies expected to announce programs outside of oncology we note UCLA scientists publish data for a 2nd generation anti-HIV1 CAR-T. UCLA’s use of engineered hematopoietic stem cells could be replaced by FATE’s induced pluripotent stem cells in our view. UCLA modified hematopoietic stem cells with a truncated CD4 CAR to target HIV envelope, that unlike the first gen CAR prevented HIV transmission as well as prevented IL-16 binding and potential non-specific CAR signaling while maintaining similar cytotoxicity against Env+ve cells. The use of 41BB as a costimulatory domain of the CAR, versus CD28 was essential for successful differentiation and improved anti-viral function. Suppression of viremia in untreated mice by the 2nd gen CAR was enhanced by combination treatment with ART which increased CAR-T persistence. The authors believe the 2nd gen CAR-T should be pursued as a clinical candidate. Separately we note an NIH manuscript describing the development of CAR-T against SIV. The studies failed to protect or gain control of viral spread. The authors identified optimal targets noting that while minimally expanded T cells were the most potent, generating large numbers was a challenge, one we note would not be an issue for an iPSC/allogeneic CAR-T. In addition, the authors observed that virus infected cells expressed Env protein for a relatively small fraction of the rapid viral lifecycle, and only towards the end when virus may be about to be released, an observation we interpret as requiring CAR-T persistence or the ability to re-dose.
AFMD should keep investors engaged over the next 15 months.
https://mattbiotech.substack.com/p/8-afmd-should-keep-investors-engaged?token=eyJ1c2VyX2lkIjoyMzUwODI2MywicG9zdF9pZCI6MzMzMTY4MjUsIl8iOiJONGVucyIsImlhdCI6MTYxNzYyMjA1OCwiZXhwIjoxNjE3NjI1NjU4LCJpc3MiOiJwdWItMjQ3MDA3Iiwic3ViIjoicG9zdC1yZWFjdGlvbiJ9.Wn2srFGmTJsw4Rvh-vNoCUNi_7YX9uNopW8OF6oOyGk&utm_source=substack&utm_medium=email&utm_content=share
Affimed (NASDAQ:AFMD) versus Spotlight Innovation (OTCMKTS:STLT) Critical Review
https://zolmax.com/investing/affimed-nasdaqafmd-versus-spotlight-innovation-otcmktsstlt-critical-review/5503524.html
Your in good company:
AFFIMED INSTITUTIONAL BUYING AND SELLING
https://www.marketbeat.com/stocks/NASDAQ/AFMD/institutional-ownership/
Point72 Asset Management, L.P. reports stake of 5.0%
One for the short crowd to take control. This is too many shorts for all Affimed has going:
Affimed (NASDAQ:AFMD) was the recipient of a significant increase in short interest in January. As of January 15th, there was short interest totalling 7,040,000 shares, an increase of 14.3% from the December 31st total of 6,160,000 shares. Based on an average daily volume of 1,660,000 shares, the days-to-cover ratio is currently 4.2 days.
Affimed stock opened at $5.74 on Friday. The stock has a market cap of $506.99 million, a PE ratio of -9.73 and a beta of 2.81. Affimed has a one year low of $1.42 and a one year high of $7.48. The stock has a fifty day moving average of $6.31 and a 200 day moving average of $4.60.
https://www.tickerreport.com/banking-finance/7035131/affimed-nasdaqafmd-short-interest-update.html
AFMD - Affimed Announces Pricing of $100,000,000 Public Offering of Common Shares
AFMD Affimed N.V. NKMax America to study AFM24, SNK01 combination
Affimed N.V. and NKMax America announced that they entered into a clinical collaboration agreement to investigate the combination of AFM24, a CD16A/EGFR-targeted ICE, with the autologous NK cell product SNK01. Pursuant to the collaboration, the companies plan to explore the combination in a first-in-human proof-of-concept trial in patients with EGFR-expressing tumors. The agreement follows a previous collaboration between the two companies in the preclinical setting to better understand the combined activity of their respective platforms. The results of the preclinical collaboration have shown substantive synergy between Affimed's ICE molecules and NKMax America's autolo gous and cryopreserved allogeneic natural killer cell products. Under the agreement, the companies will contribute their respective product candidates and resources towards submitting an Investigational New Drug application to the U.S. FDA and a subsequent clinical trial. The clinical trial will combine NKMax America's SNK01 with AFM24 in the autologous setting with the option to expand the clinical trial to the allogeneic setting. The cost of the clinical study will be shared by Affimed and NKMax America. The agreement also provides for the opportunity to pursue further clinical study combinations with additional product candidates from both parties.
Affimed and NKMax America to Study the Combination of AFM24, an EGFR-Targeted Innate Cell Engager, with SNK01 Natural Killer Cell Therapy
https://www.globenewswire.com/news-release/2020/10/20/2110884/0/en/Affimed-and-NKMax-America-to-Study-the-Combination-of-AFM24-an-EGFR-Targeted-Innate-Cell-Engager-with-SNK01-Natural-Killer-Cell-Therapy.html
Honestly i don't know. There is a good group on Twitter that follows AFMD. I'm not following it as close at the moment. All that volume and nothing, disappointing...
Did anything positive or bullish come out of the meeting tomorrow or is it just a run-of-the-mill meeting in other words will there be any updates on data or partnerships
Same. Got out last week and sure glad of it!
Any position I I traded this from 381 to 391 and then I got back in at 379 at the close
And still have core
I don't know what is going on here. I'm just watching from the sidelines...
Biotechs...
Not lookin too good
starting to hold well at these levels!
$AFMD$
Still holding all my shares! AFMD looking strong.
Another nice bounce looking for NHOD
Ever since those big black trays after hours at around $3.63 went off we’ve been going down, About 700000shares went off now below the closing price
I saw that and I was thinking that might’ve taken a little wind out of our sale what do you think but I understand where you’re coming from but it could work both ways
Blueprint deal just on CNBC reminds me of the AFMD deal with Genetech...
https://www.biospace.com/article/genentech-blueprint-ink-1-billion-deal-to-bring-new-treatment-for-ret-altered-cancers/
It’ll be interesting to see where this takes us down almost 25% in a week
All the dark pool prints? They were documented on this thread...
I made it on the high side but it looks like they’re buying the dips but not enough.... it makes one concerned this was a dollar higher a week ago percentagewise it’s huge
If it has so much going on or why would anybody be selling at four dollars
What do you mean by unusual?
If this thing has so much going for it why the selling
I hope you’re right I’m with you buddy
nah something is in the works. No Relaxing for me!
I added $4.30
I also added at 4.40 the other day
Relax you’re gonna sound like every other biotech penny stock guy talking about a take over his company that 99% of the time never happens
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