On March 9, 2017 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY), a leader in the field of therapeutic antibodies, reported results for the financial year 2016, as well as a financial and operational outlook on 2017 (Press release, MorphoSys, MAR 8, 2017, View Source [SID1234518045]).

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"2016 was a rewarding year for us. The first therapeutic antibody from our platform was filed for market approval by our pharma partner Janssen, which is a major milestone in our company’s history. We expect the decision on regulatory filing of guselkumab in the second half of 2017," said Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "In parallel, we made significant progress with our own drug candidates in 2016. Across our pipeline we see many programs which have the potential to transform the treatment of the diseases they address and thus to create value and benefit for all our stakeholders, including our partners, investors and patients."

"With a record-high of 114 programs in R&D, MorphoSys’s portfolio is one of the broadest in the biopharmaceutical industry. This pipeline is supported by financial resources of close to EUR 360 million at year-end 2016. We strengthened our financial position by a successful capital increase with gross proceeds of EUR 115.4 million in November 2016. Our financial strength enables us to invest strongly in the development of our own drug candidates to grow the Company’s value, without losing sight of our prudent and efficient use of resources," commented Jens Holstein, Chief Financial Officer of MorphoSys AG.

Financial Review for the Fiscal Year 2016 (IFRS)

In 2016 MorphoSys continued to focus on the research and development of drug candidates both for partners and on its own account. Group revenues came in at EUR 49.7 million, fully in line with expectations (2015: EUR 106.2 million). Adjusted for a 2015 one-off income of approximately EUR 59 million, 2016 revenues rose by 5% compared to the previous year.

In the Proprietary Development segment, MorphoSys focuses on the research and clinical development of its own drug candidates in the fields of cancer and inflammation. In 2016, this segment recorded revenues of EUR 0.6 million, an almost flat revenue development compared to 2015, as previous year’s numbers (2015: EUR 59.9 million) included a one-off effect of approximately EUR 59 million from the termination of the MOR202 co-development and co-promotion agreement with Celgene.

In the Partnered Discovery segment, MorphoSys applies its proprietary technology to discover new antibodies for pharmaceutical companies, benefitting from the partners’ development advancements through success-based milestone payments and royalties. In 2016, revenues were up 6% to EUR 49.1 million (2015: EUR 46.3 million). The increase was mainly driven by milestone payments from partners. Segment revenues in 2016 comprised EUR 43.6 million in funded research and license fees (2015: EUR 42.3 million) and EUR 5.6 million in success-based payments (2015: EUR 4.0 million).

Total operating expenses came in at EUR 109.8 million, exceeding last year’s numbers by 17% (2015: EUR 93.7 million). While general and administrative expenses were reduced by 7% to EUR 14.1 million (2015: EUR 15.1 million), research and development expenses were increased by 22% to EUR 95.7 million (2015: EUR 78.7 million). Intensified clinical trials with MorphoSys’s proprietary drug candidates, in particular the start of three phase 2 studies with the lead compound MOR208 in selected blood cancer indications, were the main area of focus. Proprietary R&D expenses, including technology development, rose by 39% to EUR 78.5 million (2015: EUR 56.6 million), fully meeting the Company’s guidance.

Earnings before interest and taxes (EBIT) stood at EUR -59.9 million (2015: EUR 17.2 million). Adjusted for the one-off effect in 2015, the operating loss for 2016 rose by approximately 43%, mainly based on the planned expansion of R&D activities. The Proprietary Development segment reported an EBIT of EUR -77.6 million (2015: EUR 10.7 million). EBIT in the Partnered Discovery segment was up by 52% to EUR 31.0 million (2015: EUR 20.4 million), mainly based on the increase in success-based milestone payments from partners and lower costs incurred in the segment.

In 2016, the consolidated net result amounted to EUR -60.4 million (2015: EUR 14.9 million). The diluted net result per share for 2016 was EUR -2.27 (2015: EUR 0.57).

At year-end 2016, the Company had a cash position of EUR 359.5 million compared to EUR 298.4 million on December 31, 2015. On the balance sheet, this cash position is reported under the items: cash and cash equivalents; available-for-sale financial assets; bonds, available-for-sale; financial assets classified as loans & receivables; and financial assets classified as loans & receivables, net of current portion.

The number of shares issued totaled 29,159,770 at year-end 2016 (year-end 2015: 26,537,682). The increase in the number of shares resulted from the capital increase on November 15, 2016 with gross proceeds of EUR 115.4 million, in which 2,622,088 shares were issued.

Financial Guidance and operational outlook for 2017

For the financial year 2017, MorphoSys expects to generate Group revenues in the range of EUR 46 to 51 million. R&D expenses for proprietary drug development are anticipated in a corridor of EUR 85 to 95 million. The Company expects earnings before interest and taxes (EBIT) of EUR -75 to -85 million. This guidance does not include any additional revenue from potential future collaborations and/or licensing partnerships nor effects from potential in-licensing or co-development deals for new development candidates.

"We continue to invest in our growing portfolio of highly promising proprietary drug candidates which are nearing the decisive stages of clinical development. In 2017 we will start a phase 3 study with our lead candidate MOR208 in the blood cancer indication diffuse large B cell lymphoma (DLBCL), where we see a high unmet medical need. This will be the first pivotal trial with one of our own antibodies. This marks another important step on our way to becoming a fully-integrated biopharmaceutical company, that will be increasingly based on product-based revenue streams," commented Dr. Simon Moroney.

In the Proprietary Development segment, MorphoSys expects the following events in 2017:

MOR208: Completion of the phase 2 safety run-in of the B-MIND study and initiation of the pivotal phase 3 part of the study, in which MOR208 will be tested in combination with bendamustine in comparison to rituximab and bendamustine in DLBCL.
MOR208: Presentation of first preliminary data of the phase 2 trial of MOR208 in combination with lenalidomide in DLBCL (L-MIND study).
MOR208: Initiation of another study arm of the ongoing phase 2 COSMOS trial with MOR208 in CLL in order to test MOR208 with a further combination drug. Currently, the Company is investigating the combination of MOR208 and idelalisib in this study.
MOR202: Completion of the phase 1/2a dose-escalation trial in multiple myeloma, including the results of MOR202 in the highest dose of 16 mg/kg alone and in combinations with pomalidomide and with lenalidomide.
MOR209/ES414: Continuation of the phase 1 trial of MOR209/ES414 with adapted dose regimen in prostate cancer (mCRPC) as part of the collaboration with Aptevo.
MOR106: Completion of the phase 1 trial of MOR106, co-developed with Galapagos, in atopic dermatitis.
MOR107: Completion of a phase 1 study in healthy volunteers.
MOR103/GSK3196165: For this HuCAL antibody, which has been fully out-licensed to GSK, MorphoSys expects data from a phase 2b study in rheumatoid arthritis and from a phase 2a study in hand osteoarthritis, both conducted by GSK.
In its Partnered Discovery segment, MorphoSys expects the following events in 2017:

Guselkumab: the first partner-developed therapeutic antibody based on MorphoSys’s HuCAL technology could receive market approval in 2017. MorphoSys expects that the US regulatory authority FDA should make a decision in the second half of 2017 on Janssen’s application for the approval of guselkumab to treat adults with moderate to severe psoriasis. In addition, a regulatory filing for guselkumab in Europe has been submitted.
Anetumab ravtansine, a HuCAL antibody drug conjugate developed by Bayer, is expected to report results in 2017 from a pivotal phase 2 trial in the cancer indication mesothelioma. Favourable results could support a regulatory filing of the compound.
Novartis collaboration: As previously communicated and as reflected in the Company’s 2017 guidance, MorphoSys expects the collaboration with Novartis to end at the end of November 2017 in accordance with the contract. The Company does not believe that Novartis will exercise its option to extend the contract.
In total, results may be disclosed from up to 31 different clinical studies in various phases conducted by partners with antibodies based on MorphoSys technology.
MorphoSys plans to establish additional collaborations with pharmaceutical and biotechnology companies based on the Ylanthia technology, similar to its partnership with LEO Pharma established in 2016.

MorphoSys Group Key Figures (IFRS, end of financial year: December 31)

in EUR million 2016 2015 Change Q4/2016 Q4/2015 Change
Revenues 49.7 106.2* -53% 13.0 12.3 +6%
Operating expenses 109.8 93.7 +17% 40.7 30.1 +35%
R&D expenses 95.7 78.7 +22% 36.9 25.6 +44%
Proprietary R&D expenses 78.5 56.6 +39% 32.3 16.7 +93%
G&A expenses 14.1 15.1 -7% 3.8 4.5 -16%
EBIT -59.9 17.2* >-100% -27.6 -17.5 +58%
Net result -60.4 14.9 >-100% -28.7 -13.3 >100%
Net result per share (diluted) (in EUR) -2.27 0.57 >-100% -1.04 -0.58 +79%
Cash position (end of period) 359.5 298.4 +20% 359.5 298.4 +20%
Equity ratio (end of period) (in %) 90% 91% -1 PP** 90% 91% -1 PP**
No of R&D programs (end of period) 114 103 +11 114 103 +11
No of clinical programs (end of period) 29 25 +4 29 25 +4
No of proprietary clinical programs (end of period) 5 4 +1 5 4 +1
* Adjusted by a positive one-off effect of approximately EUR 59 million in revenue and EBIT of 2015, total Group revenues reached approximately EUR 47 million and the total Group EBIT approximately EUR -42 million in 2015.
** Percentage point

MorphoSys will hold its conference call and webcast today to present the annual financial results 2016 and the outlook 2017.

On March 8, 2017 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell-based therapies, reported that the U.S. FDA authorized the initiation of the THINK trial in the U.S (Filing, 6-K, Celyad, MAR 8, 2017, View Source [SID1234518038]). THINK evaluates NKR-2 CAR-T cells in seven indications, five solid cancers and two hematological malignancies.

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"The FDA approval for the THINK trial is an important milestone allowing us to initiate the THINK clinical trial in the USA. We are now looking forward to enrolling the first patients in both solid and hematological arms of the study in the U.S.", said Christian Homsy, CEO of Celyad.

"I would like to thank the team as well as our partners for the incredible work achieved so far to make the THINK trial progress at such a good pace. In the coming months, all our efforts will be dedicated to the recruitment and follow-up of new patients for each dose-level cohort, but also to the opening of new clinical sites across EU and the U.S.", remarked Jean-Pierre Latere, Chief Operating Officer at Celyad.

On March 8, 2016 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported financial results for the three-month period and year ended December 31, 2016 (Press release, Spectrum Pharmaceuticals, MAR 8, 2017, View Source [SID1234518035]).

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"We made significant advancements in our pipeline throughout 2016 and I believe we are well positioned for transformational growth," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "ROLONTIS is our highest priority drug and we are pleased that we remain on track for a BLA filing next year. Poziotinib, which is being developed for breast cancer has recently emerged as a potential treatment for a high unmet medical need in lung cancer. Data presented in December suggests that poziotinib has potential in lung cancer patients with certain genetic mutations that have poor prognosis and limited treatment options. An investigator sponsored trial of poziotinib in such patients with EGFR Exon 20 insertion mutations at MD Anderson Cancer Center could yield key results before year end. We have also obtained a new SPA for our late-stage bladder cancer drug Qapzola that significantly reduces the number of patients required for an NDA filing. Spectrum is in a unique position of having multiple opportunities to create value while benefiting patients."

Pipeline Update:

ROLONTIS (eflapegrastim), a novel long-acting GCSF: A pivotal Phase 3 study was initiated under a SPA from the FDA in 2016 to evaluate ROLONTIS in the management of chemotherapy-induced neutropenia in patients with breast cancer. The Company is actively enrolling breast cancer patients in the current trial, expects to initiate an additional smaller Phase 3 trial, and continues to expect to file a BLA next year.
Poziotinib, a potential best-in-class, novel, pan-HER inhibitor: In collaboration with The University of Texas MD Anderson Cancer Center, an investigator sponsored trial is being initiated in non-small cell lung cancer patients with EGFR Exon 20 insertion mutations. The study is expected to yield results before year end. Spectrum is also conducting a Phase 2 breast cancer trial in the U.S., based on promising Phase 1 efficacy data in breast cancer patients who had failed multiple other HER2-directed therapies. Further, multiple Phase 2 studies are being conducted in South Korea by Hanmi Pharmaceuticals and National OncoVenture to study additional cancer indications.
Qapzola, a potent tumor-activated drug being investigated for non-muscle invasive bladder cancer: The Company received a new SPA from the FDA on a proposed Phase 3 study design. The Phase 3 study has been specifically designed to build on learnings from the previous studies, as well as recommendations from the FDA. Compared to the previous study, this study will use twice the dosage of Qapzola (8 mg), will evaluate approximately 70% fewer patients (n = 425), and will evaluate time-to-recurrence as the primary endpoint compared to recurrence at 2 years.
Three-Month Period Ended December 31, 2016 (All numbers are approximate)

GAAP Results

Total product sales were $32.2 million in the fourth quarter of 2016. Product sales in the fourth quarter included: FUSILEV (levoleucovorin) net sales of $4.3 million, FOLOTYN (pralatrexate injection) net sales of $10.7 million, ZEVALIN (ibritumomab tiuxetan) net sales of $2.5 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $2.3 million, BELEODAQ (belinostat for injection) net sales of $3.0 million, and EVOMELA (melphalan) for injection net sales of $9.4 million.

Spectrum recorded net loss of $17.4 million, or $0.22 per basic and diluted share in the three-month period ended December 31, 2016, compared to net loss of $4.2 million, or $0.06 per basic and diluted share in the comparable period in 2015. Total research and development expenses were $15.9 million in the quarter, as compared to $15.4 million in the same period in 2015. Selling, general and administrative expenses were $18.3 million in the quarter, compared to $21.2 million in the same period in 2015.

During the quarter the Company purchased $10.0 million face value of its convertible debentures for $9.0 million. The Company ended the quarter with cash and cash equivalents of $158 million.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $8.1 million, or $0.10 per basic and diluted share in the three-month period ended December 31, 2016, compared to non-GAAP net loss of $4.6 million, or $0.07 per basic and diluted share in the comparable period in 2015. Non-GAAP research and development expenses were $15.4 million, as compared to $14.8 million in the same period of 2015. Non-GAAP selling, general and administrative expenses were $15.6 million, as compared to $18.1 million in the same period in 2015.

Twelve-Month Period Ended December 31, 2016 (All numbers are approximate)

GAAP Results

Total product sales were $128.6 million for the twelve months ended December 31, 2016. Total product sales decreased 6% from $136.9 million in the same period of 2015.

Product sales in 2016 included: FUSILEV (levoleucovorin) net sales of $34.8 million, FOLOTYN (pralatrexate injection) net sales of $46.2 million, ZEVALIN (ibritumomab tiuxetan) net sales of $10.7 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $7.2 million, BELEODAQ (belinostat) for injection net sales of $13.4 million, and EVOMELA (melphalan) for injection net sales of $16.2 million.

Spectrum recorded net loss of $68.5 million, or $0.94 per basic and diluted share in the twelve-month period ended December 31, 2016, compared to net loss of $50.8 million, or $0.78 per basic and diluted share in the comparable period in 2015. Total research and development expenses were $58.9 million for the year, as compared to $50.8 million in the same period in 2015. Selling, general and administrative expenses were $87.3 million for the year, compared to $86.5 million in the same period in 2015.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $16.8 million, or $0.23 per basic and diluted share in the twelve-month period ended December 31, 2016, compared to non-GAAP net loss of $17.6 million, or $0.27 per basic and diluted share in the comparable period in 2015. Non-GAAP research and development expenses were $54.1 million, as compared to $45.7 million in the same period of 2015. Non-GAAP selling, general and administrative expenses were $64.1 million, as compared to $77.9 million in the same period in 2015.

On March 8, 2017 OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics, reported financial results for the fourth quarter and full year ended December 31, 2016 (Press release, OncoMed, MAR 8, 2017, View Source [SID1234518033]). As of December 31, 2016, cash and short-term investments totaled $184.6 million.

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"With eight OncoMed-discovered therapeutic candidates in the clinic, 14 ongoing clinical trials and active discovery efforts continuing, we are committed to discovering and developing novel drugs that will improve the lives of patients with cancer. 2017 is an important year for OncoMed. We expect to deliver data from a total of three randomized Phase 2 trials for demcizumab and tarextumab in the first half of the year," said Paul J. Hastings, Chairman and Chief Executive Officer of OncoMed. "We are also making important progress for our immuno-oncology candidates and expect to dose patients with anti-TIGIT and file an IND for GITRL-Fc trimer in the first half of the year. Simultaneously, we continue development of multiple other therapeutic candidates."

Recent Accomplishments

Filed an Investigational New Drug (IND) application for anti-TIGIT (OMP-313M32) immuno-oncology antibody in December 2017 and received clearance to proceed from the U.S. Food and Drug Administration (FDA).

Began enrollment of patients in two Phase 1b clinical trials of anti-DLL4/VEGF bispecific antibody (OMP-305B83), now known as navicixizumab, plus standard-of-care chemotherapy for the treatment of second-line colorectal and platinum-resistant ovarian cancers.

Enrolled the first patient in a Phase 1b clinical trial of brontictuzumab (anti-Notch1, OMP-52M51) combined with trifluridine and tipiracil tablets (Lonsurf) in third-line colorectal cancer. The trial will include enrollment of biomarker-positive patients whose tumors express the activated form of Notch1.
Financial Guidance and Potential Partner Opt-Ins
As stated in January 2017, OncoMed expects operating cash burn to be less than $100 million for the full year 2017. The company’s current cash is estimated to be sufficient to fund operations through the third quarter of 2018, without taking into account future potential milestone payments from partners.

In 2017, up to five clinical-stage programs, demcizumab (anti-DLL4, OMP-21M18) and anti-RSPO3 (OMP-131R10) with Celgene, tarextumab (anti-Notch2/3, OMP-59R5) with GlaxoSmithKline (GSK) and vantictumab (anti-Fzd, OMP-18R5) and ipafricept (FZD8-Fc, OMP-54F28) with Bayer, may be eligible for potential partner opt-ins worth more than $170 million in total.

Key Potential Upcoming Milestones and Events by Program

Demcizumab (anti-DLL4, OMP-21M18)

Report top-line data, including median progression-free survival (mPFS), interim median overall survival (mOS) and response rate, in the first half of 2017 from the Phase 2 YOSEMITE clinical trial of demcizumab in combination with gemcitabine plus Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin bound) in patients with first-line metastatic pancreatic cancer.

Submit the demcizumab Phase 2 data package in the first half of 2017 to Celgene for opt-in consideration.
— The Phase 2 YOSEMITE clinical trial data are expected to form the basis of the demcizumab data package. The data package will also include available data from the Phase 2 DENALI clinical trial of demcizumab plus carboplatin and pemetrexed in first-line non-small cell lung cancer (NSCLC), as well as interim safety and efficacy data from the ongoing Phase 1b clinical trial of demcizumab plus pembrolizumab (anti-PD1, Keytruda).
— OncoMed would be entitled to a $70 million opt-in payment if Celgene exercises its option to co-develop and co-commercialize demcizumab. Following option exercise, OncoMed would be responsible for one-third of global development costs, while Celgene would be responsible for the remaining two-thirds, and OncoMed and Celgene would co-commercialize demcizumab in the U.S., sharing profits 50/50, while Celgene would lead development and commercialization outside the U.S. In addition, OncoMed would be eligible for potential future milestones of up to $651 million and ex-U.S. double-digit royalties.

Complete enrollment in the Phase 1b demcizumab plus pembrolizumab clinical trial.
Tarextumab (anti-Notch 2/3, OMP-59R5)

Report top-line data, including mPFS, mOS, response rate and exploratory biomarkers, in the first half of 2017 from the Phase 2 PINNACLE clinical trial of tarextumab in combination with cisplatin/carboplatin and etoposide for the treatment of first-line small cell lung cancer (SCLC).

Submit the tarextumab data package in the first half of 2017 to GSK for opt-in consideration.
— If GSK exercises its option to obtain an exclusive license to tarextumab, OncoMed would be entitled to receive a $25 million opt-in payment, and would be eligible for potential future milestones of up to $294.5 million and worldwide royalties in the low double digits to high teens. Following exercise of its option, GSK would lead and fully fund further development and commercialization of tarextumab.
Vantictumab (anti-Fzd, OMP-18R5)

Submit vantictumab data package to Bayer in the first half of 2017 for opt-in consideration. Bayer has until June 2017 to exercise its option on vantictumab.
— If Bayer exercises its option to obtain an exclusive license to vantictumab, OncoMed would be entitled to receive a $25 million opt-in payment. Upon option exercise, Bayer would lead and fully fund further development and commercialization of vantictumab, and OncoMed would be eligible for potential future milestone payments of up to $332.5 million and worldwide royalties in the low double digits to high teens.
Ipafricept (Fzd8-Fc, OMP-54F28)

Submit ipafricept data package to Bayer in the first half of 2017 for opt-in consideration. Bayer has until June 2017 to exercise its option on ipafricept.
— If Bayer exercises its option to obtain an exclusive license to ipafricept, OncoMed would be entitled to receive a $15 million opt-in payment for ipafricept. Upon option exercise, Bayer would lead and fully fund further development and commercialization of ipafricept, and OncoMed would be eligible for potential future milestone payments of up to $332.5 million and worldwide royalties in the mid-single digits to low double digits.
Anti-RSPO3 (OMP-131R10)

Continue enrollment in the anti-RSPO3 Phase 1a/1b clinical trial. Upon the achievement of certain enrollment objectives, OncoMed plans to submit a data package to Celgene for opt-in consideration.
— If Celgene exercises its option on anti-RSPO3, OncoMed would be entitled to receive a payment of approximately $37.8 million, and the two companies would co-develop and co-commercialize anti-RSPO3 in the U.S., sharing profits 50/50, while Celgene would lead development and commercialization outside the U.S. Following option exercise, OncoMed would also be eligible for potential future milestones of up to $402.5 million and ex-U.S. royalties in the mid-single digits to mid-teens and would be responsible for one-third of global development costs, while Celgene would be responsible for the remaining two-thirds.
Immuno-Oncology Pipeline

Initiate dosing of patients in the Phase 1 clinical trial of anti-TIGIT (OMP-313M32) in the first half of 2017.

File an IND for OncoMed’s wholly owned GITRL-Fc trimer (OMP-336B11) program in the first half of 2017.
Fourth Quarter and Full Year 2016 Financial Results

Cash and short-term investments totaled $184.6 million as of December 31, 2016, compared to $157.3 million as of December 31, 2015 and $207.6 million as of September 30, 2016. Full-year cash expenses for 2016 were $115 million, consistent with the company’s 2016 guidance.

Revenues for the full year 2016 totaled $25.2 million, compared to $25.9 million in 2015. For the fourth quarter of 2016, revenue was $6.2 million, compared to $6.8 million for the fourth quarter of 2015. The decrease in revenue for the full year and fourth quarter were primarily attributable to a $2.5 million milestone for clinical candidate designation of anti-TIGIT recognized in 2015 and the achievement of a $70 million safety milestone for demcizumab received in the fourth quarter of 2015, which was recorded as deferred revenue and has been amortized over the performance period under our collaboration with Celgene.

Research and development (R&D) expenses for the full year 2016 were $109.7 million compared to $92.9 million in 2015. Increased expenditures in 2016 were primarily attributable to external manufacturing, clinical and toxicology study costs associated with the advancement of OncoMed’s clinical-stage product candidates and preclinical pipeline.

R&D expenses were $24.2 million for the fourth quarter of 2016 compared with $26.7 million for the same period in 2015. Lower R&D expenditures during the fourth quarter 2016 were attributable to timing of production of materials used in the various clinical studies and a decrease in personnel-related costs.

General and administrative (G&A) expenses for the full year 2016 and 2015 were $18.8 million and $18.6 million, respectively. The increase in 2016 was associated with higher employee-related costs, including an increase in stock-based compensation expenses. The increased expenses were offset by a decrease in legal fees related to patent filings.

For the fourth quarter of 2016, G&A expenses were $4.4 million, compared to $5.0 million for the same period in 2015. Lower G&A expenses during the fourth quarter 2016 were attributable to lower personnel costs and decreased legal costs related to patent filings.

Net loss for the year ended December 31, 2016 was $103.1 million ($3.14 per share), compared to $85.4 million ($2.84 per share) for the year ended December 31. 2015. The change in year-over-year net loss was primarily due to increases in operational expenses and lower milestone revenue.

Net loss for the fourth quarter of 2016 was $22.3 million ($0.60 per share), compared to $24.8 million ($0.82 per share) for the same period of 2015. The change in net loss was primarily attributable to a decrease in R&D expenses.

On March 8, 2017 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the "company"), an oncology-focused, clinical stage biotechnology company, reported it has entered into a licensing agreement with the Wisconsin Alumni Research Foundation (WARF) for intellectual property rights covering the method of use (MOU) for the company’s lead PDC compound, CLR 131, in multiple myeloma (Press release, Cellectar Biosciences, MAR 8, 2017, View Source [SID1234518032]).

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"We are extremely pleased to further strengthen our relationship with Cellectar," said Carrie Thome, WARF director of investments. "WARF’s ability to use the many assets that exist in our portfolio to help advance an important new technology towards ultimate commercialization is a wonderful example of the power of the unique WARF model that combines world class technology transfer and investment management capabilities."

WARF has been, and continues to be, an investor in Cellectar and has been a joint owner, with Cellectar, of the MOU patent filing for CLR 131 for the treatment of multiple myeloma. While the company has always maintained the rights to develop and commercialize CLR 131 for multiple myeloma, the execution of this licensing agreement provides the company with exclusive rights to the development and commercialization of the compound in multiple myeloma. As a result of this agreement, the company has now consolidated its control of the multiple myeloma indication, while continuing to maintain complete control for all other therapeutic uses of CLR 131.

"WARF is one of Cellectar’s largest shareholders and remains a formidable partner. We believe this expansion of our relationship further solidifies our mutual commitment," said Jim Caruso, president and CEO of Cellectar. "Acquiring the remaining rights to the use of CLR 131 in multiple myeloma now provides us with complete control over the product’s development and commercialization in all therapeutic areas."

About CLR 131
CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated as a single-dose treatment in a Phase I clinical trial in patients with relapsed or refractory multiple myeloma. In the first quarter of 2017, the company plans to initiate a Phase II clinical study to advance its multiple myeloma program, assess efficacy in a range of B-cell malignancies, and explore the clinical benefits of a second dose. Based upon preclinical and interim Phase I study data, treatment with CLR 131 provides a novel approach to treating hematological diseases and may provide patients with therapeutic benefits, including overall survival, an improvement in progression-free survival (PFS), surrogate efficacy marker response rate, and overall quality of life. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131, directly to tumor cells. The FDA has granted Cellectar an orphan drug designation for CLR 131 in the treatment of multiple myeloma.

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The company deliberately designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in more than 80 different xenograft models of cancer.

About Multiple Myeloma
Multiple myeloma is the second most common blood or hematologic cancer. It affects a specific type of blood cells known as plasma cells. Plasma cells are white blood cells that produce antibodies to help fight infections. While treatable for a time, multiple myeloma is incurable and almost all patients will relapse or the cancer will become resistant/refractory to current therapies.

The National Institute of Health’s SEER database reports the annual prevalence and incidence in the United States to be approximately 90,000 and 30,000, respectively.