Affimed N.V. (Nasdaq: AFMD) engineers targeted immunotherapies, seeking to cure patients by harnessing the power of innate and adaptive immunity (NK and T cells). It is developing single and combination therapies to treat cancers and other life-threatening diseases.
On November 7th, the company announced results for the quarter ended September 30, 2017, and provided an update on its present pipeline. AFMD continues to make great strides in validating its NK cell engager programs, in particular through encouraging data from studies of its lead candidate AFM13, which is progressing through clinical development as a mono-and combination therapy.
Leveraging its unique NK cell-based platform for high-affinity CD16A-targeting, the company is advancing its tetravalent bispecific antibodies with the potential to tailor immune-engaging therapy to different indications and settings.
Near-to medium-term catalyst includes: AFMD is scheduled to present clinical and preclinical data on its immune cell engagers AFM13 and AFM26 at the 59th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 9-12, 2017 in Atlanta, Georgia.
AFMD continues to be an industry leader in NK-cell engagement, and its lead product candidate AFM13 is one of the most advanced NK-cell engager in clinical development. The company is particularly interested in unlocking the full potential of NK-cells immunoncology through suitable combination approaches.
On the one hand the company is aiming to generate a conservative immune response through combinations of synergistic mechanisms for instance by combining its products with checkpoint inhibitors or cytokine. On the other hand, it can increase the number and activity of NK-cells available for an immune response via adoptive transfer. To this end, it formed several collaborations with industry and academia.
The company also has a well-differentiated seasonal based approach which includes its own clinical candidate AFM11, and it will provide an all its clinical programs as well as its preclinical programs to date.
The upcoming presentations results/developments are likely to be the near-term catalysts for the stock. The stock currently has an average rating of “BUY” and a consensus price target of $6.50. Considering present valuation, AFMD is at a favorable risk-reward position.
About the company: Affimed N.V. (Nasdaq: AFMD), a clinical-stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies.
NK cell engager programs:
- In Affimed’s Phase 1b combination study of its lead product candidate, the CD30/CD16Atargeting NK cell engager AFM13, with Merck’s Keytruda (pembrolizumab) in Hodgkin lymphoma (HL) the dose expansion cohort is open and recruiting. The Company intends to present detailed dose escalation data including response data of the three remaining patients in cohort three at the upcoming ASH 2017 Annual Meeting in December.
- Affimed is supporting a translational Phase 1b/2a study of AFM13 in patients with relapsed or refractory CD30-positive lymphoma with cutaneous manifestation led by Columbia University.
- The Company has developed multiple tetravalent, bispecific antibody formats in addition to its TandAbs. These molecules confer distinct biophysical properties aimed at tailoring PK profiles.
- Affimed is currently evaluating its novel format-based AFM24 molecules, which have significantly longer half-lives, in comparison to the Company’s TandAbs, which have already shown evidence of a beneficial safety profile.
T cell engager programs
- Affimed is conducting two clinical Phase 1 dose-escalation trials with AFM11, a CD3/CD19- targeting tetravalent bispecific T cell engager in patients with relapsed and refractory (r/r) acute lymphocytic leukemia (ALL) and with r/r non-Hodgkin lymphoma (NHL), respectively. Both studies are ongoing and recruiting.
- Recruitment is ongoing into a first-in-human Phase 1 dose escalation trial of AMV564 conducted by Amphivena Therapeutics, Inc. in patients with r/r acute myeloid leukemia (AML). AMV564 is a CD33/CD3-specific antibody based on Affimed’s technology platform. Affimed owns ~18.5% of Amphivena (fully diluted).
Third Quarter Financial Results
Cash and cash equivalents and financial assets totaled €41.8 million as of September 30, 2017, compared to €44.9 million as of December 31, 2016.
Revenue for the third quarter of 2017 was €0.5 million compared to €0.9 million for the third quarter of 2016. Revenue in the 2017 period was derived from AbCheck services while revenue in the 2016 period related predominantly to Affimed’s collaboration with Amphivena.
Net loss for the third quarter of 2017 was €8.1 million, or €0.18 per common share, compared to a net loss of €10.3 million, or €0.31 per common share, for the third quarter of 2016. The decrease of operating expenses was partially offset by lower revenue and higher finance costs.
Key risk factors and potential stock drivers:
The favorable outcome of the upcoming catalysts (as mentioned above) is expected to provide a boost to the stock to retain its momentum. Any adversities related with the same could upset the stock performance significantly.
AFMD presently has net level losses. Therefore, any crunch in its liquidity and financial flexibility will further impact its business & financial profile.
The company’s near-term stock movement is also dependent on its upcoming quarterly result, any significant adversities/lower than expected guidance could adversely affect the investor sentiments.
Biotech space in itself is a high-risk sector due to uncertainties associated with the novel drug development. Therefore, favorable outcome of the upcoming catalyst is necessary for the stock to retain its momentum. Any adversities related to the same could impinge the stock performance significantly.
- On Monday, November 27th, 2017, AFMD was at $2.00 (down by -4.76%) on volume of 115K shares exchanging hands. Market capitalization is $91.46 million. The current RSI is 47.09
- In the past 52 weeks, shares of AFMD have traded as low as $1.65 and as high as $2.95
- At $2.00, shares of AFMD are trading below its 50-day moving average (MA) at $2.11 and below its 200-day moving average (MA) at $2.20.
- The present support and resistance levels for the stock are at $2.00 & $2.20 respectively.
Welcome to Traders News Source
Our track record speaks for itself…
Traders News Source recent profiles and track record, 487% in verifiable potential gains for our members on 3 small cap alerts alone! These are just three examples from over two dozen winners this year.
January 31st, 2017 (NASDAQ: HIMX) opened at $5.10/share and hit a high of $9.68/share March 24th, 2017 for gains of 89% within 60 days- http://finance.yahoo.com/news/himax-technologies-review-4q-2016-130000319.html
May 23rd, 2016- (NYSE: XXII) opened at $.87/share hit a high of $3.03/share so far our member potential gains- 248% – http://mailchi.mp/tradersnewssource/updates-5-of-our-profiles-for-212-400-and-whats-coming-next?e=[UNIQID]
October 31st, 2017 (NASDAQ: PYDS) Although we have been covering this security for over a year, our recent coverage October 31st, 2017 opened at $1.45/share hit $4.10 within three days for gains of over 150%- http://mailchi.mp/tradersnewssource/update-pyds-back-in-the-value-zone-with-news-out?e=[UNIQID]
So, if you’ve been on the fence, perhaps it’s time to start doing some research and verify our numbers for yourself. We are constantly raising the bar and separate ourselves from the rest of the small-cap newsletters as the best in business.
We know with a large following comes a large responsibility as we have everyone from institutional investors to the beginner following our profiled securities in our newsletter. This is something we take very seriously always seeking small cap growth companies that have both near and long-term potential for our members.
Big Opportunities Trading Small Cap Stocks
***Get our small cap profiles, special situation and watch alerts in real time. We are now offering our VIP – SMS/text alert service for free, simply text the word “Traders” to the phone number “25827” from your cell phone***
Traders News Source is a wholly owned subsidiary of Traders News Source LLC, herein referred to as TNS LLC.
Traders News Source has not been compensated for this report by anyone and the opinions if any are that of the author Vikas Agrawal, CFA. Author’s Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I, wrote this article myself, and it expresses my own opinions. I have no business relationship with any company whose stock is mentioned in the article.
This web site, published by TNS LLC, and is an investment newsletter that is built on the premise of assisting individual investors in learning about investing. Our goal as publishers of financial information is to provide research and analysis of investments to our subscribers. TNS LLC does not give buy or sell recommendations. We do purchase distribution rights from analyst, financial writers and bloggers for a fee that may be licensed to issue price targets and recommendations. Furthermore, we encourage you to speak to a licensed professional prior to making an investment in any type of publicly traded security.
We do sell advertising to other companies including brokerage firms, web sites, publicly traded issuers, investor relations firms, and investment publications, among others. TNS LLC makes no warranty as to the policies of these organizations, and in no way endorses their offers, services, or the content of their advertisements.
When an advertiser is a publicly traded company or a third party acting on behalf of a public company, we fully disclose all compensation in the email advertisement. Such disclosure is included in a disclosure statement in each of the advertisements sent via email.
Our reports/releases are a commercial advertisement and are for general information purposes ONLY. We are engaged in the business of marketing and advertising companies for monetary compensation. Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. The disclaimer is to be read and fully understood before using our services, joining our site or our email/blog list as well as any social networking platforms we may use.
PLEASE NOTE WELL: TNS LLC and its employees are not a Registered Investment Advisor, Broker Dealer or a member of any association for other research providers in any jurisdiction whatsoever.
Release of Liability: Through use of this website viewing or using you agree to hold TNS LLC, its operator’s owners and employees harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damage (monetary or otherwise), or injury (monetary or otherwise) that you may incur. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data. TNS LLC encourages readers and investors to supplement the information in these reports with independent research and other professional advice. All information on featured companies is provided by the companies profiled, or is available from public sources and TNS LLC makes no representations, warranties or guarantees as to the accuracy or completeness of the disclosure by the profiled companies. None of the materials or advertisements herein constitute offers or solicitations to purchase or sell securities of the companies profiled herein and any decision to invest in any such company or other financial decisions should not be made based upon the information provide herein. Instead TNS LLC strongly urges you conduct a complete and independent investigation of the respective companies and consideration of all pertinent risks. Readers are advised to review SEC periodic reports: Forms 10-Q, 10K, Form 8-K, insider reports, Forms 3, 4, 5 Schedule 13D.
TNS LLC is compliant with the Can Spam Act of 2003. TNS LLC does not offer such advice or analysis, and TNS LLC further urges you to consult your own independent tax, business, financial and investment advisors. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor’s investment may be lost or impaired due to the speculative nature of the companies profiled.
The Private Securities Litigation Reform Act of 1995 provides investors a ‘safe harbor’ in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical fact may be “forward looking statements”. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as “projects”, “foresee”, “expects”, “will”, “anticipates”, “estimates”, “believes”, “understands”, or that by statements indicating certain actions & quote; “may”, “could”, or “might” occur.
Understand there is no guarantee past performance will be indicative of future results. In preparing this publication, TNS LLC has relied upon information supplied by its customers, publicly available information and press releases which it believes to be reliable; however, such reliability cannot be guaranteed. Investors should not rely on the information contained in this website. Rather, investors should use the information contained in this website as a starting point for doing additional independent research on the featured companies. The advertisements in this website are believed to be reliable, however, TNS LLC and its owners, affiliates, subsidiaries, officers, directors, representatives and agents disclaim any liability as to the completeness or accuracy of the information contained in any advertisement and for any omissions of materials facts from such advertisement. TNS LLC is not responsible for any claims made by the companies advertised herein, nor is TNS LLC responsible for any other promotional firm, its program or its structure.