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Report for: Affimed N.V.
Heidelberg, Germany, March 30, 2016 – Affimed N.V. (Nasdaq: AFMD), a clinical stage
biopharmaceutical company focused on discovering and developing highly targeted cancer
immunotherapies, today reported financial results for the fourth quarter and year ended December
31, 2015.
“2015 was a formative year for Affimed,” said Dr. Adi Hoess, CEO of Affimed. “Through the
continuous support of our investors we were able to broaden the development of our NK- and Tcell-recruiting
immunotherapies. We have continued to successfully advance our clinical and
preclinical pipeline and, in particular, we have made significant headway with our lead candidate
AFM13 toward development as both mono- and combination therapy.”
Corporate Highlights
Affimed closed two major financings in 2015. In May, the Company completed a follow-on
offering on the Nasdaq Global Market, raising a total of approximately US $37.5 million
(€33.5 million) in net proceeds and in October, Affimed raised $21.8 million (€19.1 million)
from Aeris Capital, a long-term existing shareholder. Proceeds from these two transactions
are expected to fund operations, including clinical development and further discovery and
early development activities, until the first quarter of 2018.
Together with its collaboration partner, Stanford University, Affimed presented evidence of
the synergistic effect of the Company’s lead candidate, AFM13, a bispecific CD30/CD16A
NK-cell-engaging TandAb, in combination with checkpoint modulators including checkpoint
inhibitor anti PD-1, at the American Society of Clinical Oncology (ASCO) and American
Society of Hematology (ASH) annual meetings in May and December, respectively. Data
from four individual studies of in vivo PDX models with human CD30-positive Hodgkin
lymphoma (HL) tumors consistently showed that combination therapy of AFM13 with anti
PD-1, but not treatment with anti PD-1 alone, rapidly enriches the tumor microenvironment
with NK-cells, followed by subsequent tumor infiltration by T-cells as well as substantially
elevated levels of cytokines within the tumor, indicating AFM13’s unique ability to trigger
the body’s natural immune cascade.
The Company established operations in the United States and strengthened its US
presence with the addition of Caroline Stewart (Head of Investor Relations) and Dr. Oscar
Kashala (Vice President, Medical, US) in June, and of Andrew Curtis (Head of Corporate
Strategy and Business Development) in December.In June, Affimed formalized a Scientific Advisory Board comprising renowned scientists
and physicians from a broad range of areas relevant to Affimed’s approach including
immuno-oncology, NK-cells, lymphoma and leukemia.Affimed’s wholly owned subsidiary, AbCheck, and Pierre Fabre Pharmaceuticals entered
into a strategic research partnership in the field of human antibody discovery and
optimization in June, expanding their ongoing collaboration. Together with its partner
Distributed Bio, Inc., AbCheck developed a novel, highly potent technology enabling
accelerated humanization of rabbit antibodies.
Affimed was added to two performance indices in 2015, the Russell 2000 Index® in June
and the NASDAQ Biotechnology Index® in December, respectively.
In early 2016, Affimed strengthened its management team through the addition of Dr. Joerg
Windisch as Chief Operating Officer. With his broad expertise in regulatory affairs, quality
control and project management and his proven track record in the development and
manufacturing of marketed biologics, Dr. Windisch will support the Company’s expanding
clinical pipeline.
Affimed announced the addition of Dr. Bernhard Ehmer to its Supervisory Board in January
2016. Dr. Ehmer is a seasoned expert in the industry with extensive international general
management and clinical development experience in biopharmaceuticals.
In January 2016, Affimed entered into a collaboration with Merck to evaluate AFM13 in
combination with Merck’s KEYTRUDA® in relapsed/refractory HL.
Pipeline Updates
AFM13
In the second quarter of 2015, a Phase 2a clinical trial in relapsed/refractory HL was
initiated for the Company’s lead candidate, AFM13, a bispecific CD30/CD16A NK-cellengaging
TandAb. Patient enrollment is ongoing and interim data are expected in the
second quarter of 2016, with primary endpoint data anticipated to be reported by the end
of 2016.
An additional Phase 1b trial in relapsed/refractory HL patients with AFM13 in combination
with Merck’s anti PD-1 checkpoint inhibitor KEYTRUDA® (pembrolizumab), designed to
establish a dosing regimen for the combination therapy and assess its safety and efficacy
is on track to be initiated in the first half of 2016.
Affimed is supporting an investigator-sponsored translational Phase 1b/2a trial in CD30-
positive lymphoma with cutaneous manifestation in collaboration with Columbia University
for which Columbia submitted an IND to the FDA that has since become effective.
AFM11
For Affimed’s second candidate, AFM11, a bispecific CD19/CD3 T-cell-engaging TandAb,
patient enrollment continued into the amended Phase 1 study in non-Hodgkin lymphoma
(NHL). The Company’s amended study protocol allows for investigation of less frequent
dosing of AFM11, benefiting the overall development of AFM11. Based on the revised
protocol, Affimed expects to report first data by the end of 2016.
Affimed will investigate AFM11 in acute lymphocytic leukemia (ALL) in a separate Phase 1
clinical trial rather than sequentially, which is anticipated to help optimize
Preclinical programs
In May 2015, Affimed reported pre-clinical data on its collaborative CD33/CD3 program for
the treatment of acute myeloid leukemia (AML) with Amphivena/Janssen at the ASCO 2015
Annual Meeting. This program validates the robustness of Affimed’s TandAb platform, and
the data demonstrated corroborative evidence of direct correlation between binding affinity
and potency.
Affimed presented data at several scientific conferences in 2015 showing high specificity
and cytotoxic potency of its EGFRvIII/CD3-targeting T-cell TandAb AFM21 and its
EGFRvIII/CD16A-targeting NK-cell TandAb AFM22.
Affimed is also developing AFM24, an NK-cell-engaging TandAb targeting EGFR-wild
type, which is expressed by a variety of solid tumors, such as colorectal cancer (CRC),
non-small cell lung cancer (NSCLC) or squamous cell carcinomas of the head and neck
(SCCHN). Our data suggest that EGFR/CD16A TandAbs are suited to overcome the
intrinsic or acquired resistance to other EGFR-targeting treatments such as tyrosine
kinase inhibitors or monoclonal antibodies, which has been observed in a large number of
patients.
Financial Highlights
(Figures for the fourth quarter of 2015 and 2014 represent unaudited figures)
Cash and cash equivalents totaled €76.7 million as of December 31, 2015 compared to €39.7
million as of December 31, 2014. The increase was primarily attributable to the completion of
Affimed’s follow-on offering of its common shares on May 12, 2015, and the sale of additional
shares to Aeris Capital on October 9, 2015.
Net cash used in operating activities for the fourth quarter of 2015 was €4.0 million compared to
€5.4 million for the fourth quarter of 2014. Net cash used in operating activities was €18.5 million
for the twelve months ended December 31, 2015 compared to €10.5 million for the twelve months
ended December 31, 2014. The year-over-year increase was primarily related to higher cash
expenditure for research and development (R&D) in connection with our development and
collaboration programs and to higher general and administrative expenses.
Financial Highlights
(Figures for the fourth quarter of 2015 and 2014 represent unaudited figures)
Cash and cash equivalents totaled €76.7 million as of December 31, 2015 compared to €39.7
million as of December 31, 2014. The increase was primarily attributable to the completion of
Affimed’s follow-on offering of its common shares on May 12, 2015, and the sale of additional
shares to Aeris Capital on October 9, 2015.
Net cash used in operating activities for the fourth quarter of 2015 was €4.0 million compared to
€5.4 million for the fourth quarter of 2014. Net cash used in operating activities was €18.5 million
for the twelve months ended December 31, 2015 compared to €10.5 million for the twelve months
ended December 31, 2014. The year-over-year increase was primarily related to higher cash
expenditure for research and development (R&D) in connection with our development and
collaboration programs and to higher general and administrative expenses.
Revenue for the fourth quarter of 2015 was €1.7 million compared to €0.1 million for the fourth
quarter of 2014 due to revenue earned under the Amphivena collaboration in the 2015 period.
Revenue for the full year 2015 was €7.6 million compared to €3.4 million for the full year 2014.
Revenue in both periods was primarily derived from Affimed’s collaborations with Amphivena and
the LLS as well as from third party services rendered by AbCheck.
R&D expenses for the fourth quarter of 2015 were €7.0 million compared to €4.1 million for the
fourth quarter of 2014. For the full year 2015, R&D expenses were €22.0 million compared to €9.6
million for the full year 2014. The increase was primarily related to higher expenses for AFM13,
other preclinical programs and infrastructure.
G&A expenses for the fourth quarter of 2015 were €2.0 million compared to €1.7 million for the
fourth quarter of 2014. For the full year 2015, G&A expenses were €7.5 million compared to €2.3
million for the full year 2014. The increase was primarily related to a credit to the share-based
payment expense resulting from a re-measurement gain at consummation of the IPO in 2014.
Net loss for the fourth quarter of 2015 was €6.3 million, or €0.19 per common share, compared to
a net loss of €5.3 million, or €0.22 per common share, for the fourth quarter of 2014. Net loss for
the full year 2015 was €20.2 million, or €0.71 per common share, compared to a loss of €0.3
million, or €0.01 per common share, for the full year 2014. The increase in net loss for the full year
2015 is primarily related to non-operational and non-cash effects in 2014 upon the corporate
reorganization at the time of the IPO in September 2014 as well as to increased spending on
infrastructure and on research and development commensurate with the ramp-up of the clinical
trials for our lead product candidate AFM13 and for our preclinical programs in 2015. Additional
information regarding these results is included in the notes to the consolidated financial statements
as of December 31, 2015 and “Item 5. Operating and Financial Review and Prospects,” which will
be included in Affimed’s Annual Report on Form 20-F as filed with the SEC.
Source – Affimed Press Release
Broad street alerts has not been compensated for the mention of any publicly traded companies in this article nor do we own positions in any of the companies in this article.
Broad Street Alerts was previously compensated eighteen thousand five hundred dollars by star media llc for the mention of FNJN however, that contract has expired.
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