Agenus (AGEN) is a project in the making since the firm has decided to play an integral part in immuno-oncology, doing everything possible towards building checkpoint modulator antibodies, in addition to its protective and therapeutic vaccines.
Missing analysts’ expectation by one cent, which leads to stocks’ punishment has become an accepted routine, satisfying daily traders and other investors. The substance, however, which interests us, is in what the firm has accomplished in 2015 and continues to do now towards becoming a leader in immunotherapy.
According to comments made by Garo H. Armen, Ph.D., Chairman and CEO of Agenus, the firm has made a series of important strategic acquisitions in order to speed discovery and development, as well as to improve the quality of its programs.
Agenus strategic alliances with Incyte (INCY) and Merck (MRK) validated its efforts towards its discovery capabilities and multidisciplinary approach. They point to the fact that the future of cancer therapy will be based on the ability of identifying subpopulations of patients that are likely to best respond to specific immuno-oncology (I/O) agents or combinations. The successful outcome of immunotherapy treatments requires tailored combinations of I/O modalities, including antibodies, vaccines and adjuvants, and cell therapies. That’s what Agenus has done and is being doing; to assembling the critical parts of what could bring the decisive success of immunotherapy.
In 2015, Agenus strengthened our cash position through partnerships, a stock offering and a non-dilutive royalty financing, all affording the company a financial runway through the first half of 2017.2015
HIGHLIGHTS AND CURRENT UPDATES
January: Leveraged in-house resources through a global license, development and commercialization agreement with Incyte (INCY).
The Incyte alliance agreement focused on the development of four CPM antibodies targeting GITR, OX40, LAG-3 and TIM-3. This initial goal was expanded in November 2015 to include three additional undisclosed targets.
The BEEF: Agenus and Incyte share costs and profits equally for the GITR and OX40 programs, as well as two of the undisclosed programs.
Agenus received a $60 million upfront payment, which included a $35 million equity investment.
Agenus is also eligible to receive up to $350 million in development, regulatory and commercial milestones across the initial four lead programs.
April / November: Acquisition of Celexion, LLC, SECANT® yeast display platformand the agreement with IONTAS® for exclusive license to a proprietary phage display library aimed at Optimizing Agenus discovery of antibodies.
May: Raising approximately $75 million through a public offering of common stock.
July: Acquiring Diatheva s.r.l., an Italian biotech company for the rights to its antibodies targeting Carcinoembryonic Antigen Cell Adhesion Molecule 1 (CEACAM1), a glycoprotein expressed on T-cell and NK-cell lymphocytes
September: Agenus raised net proceeds of approximately $78 million in a non-dilutive royalty transaction pursuant to a Note Purchase Agreement with an investor group led by Oberl and Capital Management, LLC.
The Investor Group received the rights to worldwide royalties on future sales of GlaxoSmithKline’s (GSK) shingles (HZ/su) and malaria (RTS,S) prophylactic vaccine products that contain Agenus’ QS-21 adjuvant to repay principal and interest. At its option, Agenus has the right to buy back the loan at any time under pre-specified terms. Agenus also has the right to receive an additional $15 million in cash from the investors after approval of HZ/su by the FDA, provided such approval occurs by June 30, 2018. This financing also allows Agenus to retain any upside from vaccine royalties remaining after the loan terms are satisfied.
Agenus secured its own antibody manufacturing capability through the acquisition of Xoma’s (XOMA) antibody manufacturing pilot plant and access to Selexis’ cell line development technologies.
Agenus expanded its cancer vaccine program by acquiring privately-held PhosImmune Inc.,
PhosImmune has a portfolio of cancer neoantigens based on aberrant phosphorylation of proteins. The acquisition provides Agenus the ability to potentially accelerate the development of novel off-the-shelf and personalized cancer vaccines and is synergistic with Agenus’ AutoSynVax™ (ASV) vaccine program for targeting patient-specific tumor neoantigens.
Advanced first two checkpoint modulator antibodies toward the clinic by submitting Investigational New Drug (IND) applications to the FDA for AGEN1884 (a CPM antibody that binds to CTLA-4) and INCAGN01876 (a CPM antibody that targets GITR and is partnered with Incyte).
The FDA cleared both IND applications in January 2016.
Upcoming 2016 Program Milestones and Events:
Initiation of Phase 1 clinical trials for anti-CTLA-4 antibody candidate (AGEN1884; wholly owned by Agenus), and for anti-GITR antibody candidate (INCAGN01876, partnered with Incyte) in the first half of 2016.
Initiation of Phase 1 clinical trials for one or more additional CPM antibody candidates in the second half of 2016.
Initiation of a well-controlled randomized Prophage™ clinical vaccine trial in newly diagnosed glioblastoma in the second half of 2016.
Initiation of Phase 1 clinical trial with the firm’s first ASV vaccine product candidate in the second half of 2016.
Agenus’ ASV program targets cancer neoantigens with an autologous synthetic vaccine approach.
GlaxoSmithKline (GSK) will file for regulatory approval of its shingles vaccinecandidate containing Agenus’ proprietary QS-21 Stimulon® adjuvant in the second half of 2016.
Initiation of combination trials with Agenus vaccines and CPM antibody candidates in the second half of 2016.
The above was Agenus accomplishments, acquisitions and alliances without any further analysis or interpretations. Regarding the Q4 and whole year 2015 financial results: We do not know about analysts’ estimates and we do not care about the firm’s missing these estimations by one cent. We surely understand, however, that the above achievements cost much more than the firm used to spend prior to its acquisitions of other firms and of important technologies. During 2015 Agenus filed two IND’s for the new immunotherapy drugs and got the acceptance of the FDA in one month. This is a step forward towards realizing its goal to become a reliable developer of immune checkpoint protein inhibitors drugs.
Good news is that after spending towards achieving all the above-mentioned tasks, Agenus was capable of having cash, cash equivalents and short-term investments of $171.7 million as of December 31, 2015.
We do not not intend to get lost in financial details that mean nothing compared to the future success of this firm in reaching its goals. The agreement with Incyte is expected to boost the firm’s finances and capabilities to reach its targets. The possible approval of the shingle’s drug could also be a game changer in Agenus future.
We believe Agenus is walking the right road towards a smiling future.