On March 12, 2019 Vect-Horus and RadioMedix reported the signing of a Letter of Intent (LOI) to establish an agreement for the co-development of a Vect-Horus theranostic agent for the diagnostic and radiotherapy of Glioblastoma Multiforme (GBM) of the brain (Press release, RadioMedix, MAR 12, 2019, View Source [SID1234534235]).

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This partnership will marry the expertise of Vect-Horus in targeting tumors with its technology VECTrans and the know-how of RadioMedix in developing and conducting pre-clinical evaluation and clinical trials with radiopharmaceuticals.

GBM is the most common and most aggressive malignant type of primary brain tumors and is a serious and life-threatening condition. The theranostic agent targets the Low-Density Lipoprotein Receptor (LDLR), which is highly expressed on many cancer cells, including glioblastoma. Positron Emission Tomography (PET) imaging and biodistribution studies in human glioblastoma xenograft and orthotopic models have shown a significant accumulation of the agent within the tumor.

"We are pleased that our technology, VECTrans in combination with expertise of RadioMedix will serve to advance an innovative and promising approach for glioblastoma treatment." said Alexandre Tokay, CEO of Vect-Horus "This co-development project is fully aligned with our strategy to expand the use of our technology in cancer indications with high unmet medical needs."
"We look forward to very compelling outcomes from our co-development project, as we seek to create new technologies for the benefit of cancer patients, by giving doctors and hospitals more imaging and treatment options." Said D.r Jamal Temsamani, Director of Drug Development of Vect-Horus.

"Development of a highly sensitive and effective theranostic approach for GBM has always been among our top priorities. Our initial evaluation of VECTrans technology appears to be extremely promising." said D.r Ebrahim Delpassand, CEO of RadioMedix. "Our plan is to utilize VECTrans technology to initially develop an accurate molecular diagnostic PET/CT probe to precisely map the tumor involvement in the brain. This will significantly improvethe precision of the surgical resection of the tumor. The treatment will then be followed by targeted alpha-emitter or beta-emitter radionuclide therapy using the same technology to eradicate any residual malignant cells at the molecular level" added Dr. Delpassand.

"RadioMedix has strong interests and all expertise needed to develop the VECTrans–based radio-theranostic agents for GBM", said Izabela Tworowska, Ph.D., CSO of RadioMedix. "Targeting LDLR can improve the blood-brain barrier (BBB) permeability of the drug and selectively deliver the isotope payload to GBM cancer cells."

On March 12, 2019 Eli Lilly and Company (NYSE: LLY) reported that its Phase 3 RELAY study of CYRAMZA (ramucirumab) met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement in the time patients lived without their cancer growing or spreading after starting treatment (Press release, Eli Lilly, MAR 12, 2019, View Source [SID1234534255]). The Phase 3 global, randomized, double-blind trial is evaluating CYRAMZA in combination with erlotinib, compared to placebo in combination with erlotinib, as a first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have activating EGFR mutations.

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The safety profile observed in the RELAY study was consistent with what has been previously observed for CYRAMZA in Phase 3 clinical trials and the established safety profile of erlotinib. The most common (>5% incidence) Grade ≥3 adverse events occurring at a higher rate (≥5% difference) on the CYRAMZA-plus-erlotinib arm compared to the placebo-plus-erlotinib arm were hypertension, dermatitis acneiform (an acne-like rash), and diarrhea. Detailed efficacy and safety results will be submitted for presentation at a medical meeting in 2019.

"Despite recent treatment advances in metastatic EGFR-mutated non-small cell lung cancer, prognosis remains poor and there is an ongoing need for additional first-line treatment options to help patients with this deadly disease," said Maura Dickler, M.D., vice president of late phase development, Lilly Oncology.

There is no cure for people with metastatic lung cancer. The disease is associated with low survival rates and disease progression following acquired resistance remains a challenge. Most patients receive several lines of treatment and the therapeutic regimen prescribed for first-line treatment can impact a person’s options for later lines of treatment. Tyrosine kinase inhibitors (TKIs) are the current standard treatment option for EGFR-mutated NSCLC. Erlotinib, the TKI included in the RELAY trial regimen, is a globally recognized standard of care for this type of lung cancer.

"We are excited about these results, which show CYRAMZA plus erlotinib significantly delayed disease progression in this patient population. The RELAY trial is another example of Lilly’s deep commitment to providing new treatment options to patients with lung cancer," said Dr. Dickler. "We would like to thank the patients, investigators and clinical trial sites that are participating in the RELAY study, and we look forward to working with regulatory authorities globally on our submissions."

Lilly intends to initiate global regulatory submissions in mid-2019.

RELAY is the second positive Phase 3 study of CYRAMZA in metastatic NSCLC. In the positive Phase 3 REVEL study, CYRAMZA plus docetaxel was compared to placebo plus docetaxel in people with metastatic NSCLC whose cancer had progressed on or after prior platinum-based chemotherapy for locally advanced or metastatic disease. The primary endpoint of overall survival was met, as well as key secondary endpoints of PFS and response rate. The REVEL results supported CYRAMZA’s current indication in second-line NSCLC.

Results of previously completed Phase 3 studies of CYRAMZA have also supported approvals in second-line gastric and colorectal cancer. Based on the REACH-2 results, Lilly has made regulatory submissions in the U.S., EU and Japan for the use of CYRAMZA in second-line treatment of patients with hepatocellular carcinoma.

About the RELAY Trial
RELAY is a global randomized, double-blind, placebo-controlled Phase 3 study of CYRAMZA in combination with erlotinib, compared to placebo in combination with erlotinib, as a first-line treatment in previously untreated patients with metastatic NSCLC whose tumors have EGFR (epidermal growth factor receptor) exon 19 deletions or exon 21 (L858R) substitution mutations. Initiated in 2015, the study randomized 449 patients across North America, Europe and Asia. The primary endpoint of the RELAY trial is progression-free survival; key secondary endpoints include safety, response rate, overall survival, and patient-reported outcomes.

About Lung Cancer and EGFR Mutations
Lung cancer is the leading cause of cancer death in the U.S. and most other countries, killing nearly 1.7 million people worldwide each year.1 In the U.S., lung cancer is responsible for approximately 25 percent of all cancer deaths, more than those from breast, colon and prostate cancers combined.2 Non-small cell lung cancer (NSCLC) is much more common than other types of lung cancer and accounts for about 80 to 85 percent of all lung cancer cases.3 Stage IV NSCLC is a very difficult-to-treat cancer and the prognosis is poor for metastatic NSCLC.4

EGFR is a protein that helps cells grow and divide. When the EGFR gene is mutated it can cause the protein to be overactive, resulting in the formation of cancer cells. EGFR mutations may occur in 10 to 35 percent of NSCLC tumors globally.5 Activating EGFR mutations are found in about 10 to 20 percent of Caucasian patients with lung adenocarcinomas and in up to 40 to 60 percent of Asian patients.6,7,8 Regardless of ethnicity, these mutations are commonly found in females, non-smokers and those with adenocarcinoma histology.9,10 The most common EGFR mutations are activating exon 19 deletion and exon 21 (L858R) substitution mutations, which are present in over 90 percent of EGFR-mutated tumors.7,8

About CYRAMZA (ramucirumab)
In the U.S., CYRAMZA (ramucirumab) is approved for use as a single agent or in combination with paclitaxel as a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy. It is also approved in combination with docetaxel as a treatment for people with metastatic non-small cell lung cancer (NSCLC) whose cancer has progressed on or after platinum-based chemotherapy. Additionally, it is approved with FOLFIRI as a treatment for people with metastatic colorectal cancer (mCRC) whose cancer has progressed on or after therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

CYRAMZA is being investigated in a broad global development program that has enrolled more than 14,000 patients across more than 100 trials worldwide. These include several studies investigating CYRAMZA in combination with other anti-cancer therapies for the treatment of multiple tumor types.

Ramucirumab is an antiangiogenic therapy. It is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that specifically binds and blocks activation of VEGF Receptor 2 by blocking the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D. Ramucirumab inhibited angiogenesis in an in vivo animal model.

About Angiogenesis and VEGF Protein
Angiogenesis is the process of making new blood vessels. In a person with cancer, angiogenesis creates new blood vessels that give a tumor its own blood supply, allowing it to grow and spread.

Some tumors create proteins called VEGF. These proteins attach to the VEGF receptors of blood vessel cells causing new blood vessels to form around the tumors, enabling growth. Blocking the VEGF protein from linking to the blood vessels helps to inhibit tumor growth by slowing angiogenesis and the blood supply that feeds tumors. Of the three known VEGF receptors, VEGF Receptor 2 is linked most closely to VEGF-induced tumor angiogenesis.

INDICATIONS
Gastric Cancer
CYRAMZA, as a single agent or in combination with paclitaxel, is indicated for the treatment of patients with advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

Non-Small Cell Lung Cancer
CYRAMZA, in combination with docetaxel, is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA.

Colorectal Cancer
CYRAMZA, in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

On March 12, 2019 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, reported financial results for the year and three months ended December 31, 2018 and reported on corporate developments (Press release, Aptose Biosciences, MAR 12, 2019, View Source [SID1234534277]).

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The net loss for the quarter ended December 31, 2018 was $6.3 million ($0.17 per share) compared with $3.3 million ($0.12 per share) in the quarter ended December 31, 2017. Total cash and cash equivalents and investments as of December 31, 2018 were $15.7 million. Based on current operations, cash on hand and available sources of capital provides the Company with sufficient resources to fund research and development and operations into 1H 2020.

As previously disclosed, effective December 31, 2018, Aptose became a domestic issuer under the rules of the U.S. Securities and Exchange Commission. As a result, the December 31, 2018 annual financial statements are prepared in accordance with US GAAP, with such change being applied retrospectively. Accordingly, Aptose will report the year ended December 31, 2018 on Form 10-K, and subsequent quarters on Form 10-Q, and will file a new preliminary Base Shelf Prospectus on Form S-3 to replace the existing shelf previously filed on Form F-10.

"2018 was a year of significant progress for Aptose," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "One of the key events of the year was the return of APTO-253 to the clinic in patients with relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS). We completed the 28-day treatment cycle for the first patient in the trial – and not only was the drug well tolerated, but there was clear evidence of MYC inhibition and P21 induction even at the lowest dose level of 20 mg/m2. APTO-253 is the only known clinical-stage molecule that can directly inhibit expression of the MYC oncogene, which is a common driver in many malignancies, including AML and MDS. We are screening now for a second patient, who will receive a higher dose of 40 mg/m2, and assuming that goes well, we will dose escalate from there. During 2018 we also completed all of the pre-IND studies needed to advance our oral, first-in-class pan-FLT3/pan-BTK inhibitor CG-806 into the clinic and I am pleased to report we recently filed our IND for CG-806. We are eager to begin treating patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and other B cell malignancies driven by overexpression of wild type or C481S mutated BTK and who failed or are intolerant to standard therapies, as well as for patients with relapsed/refractory acute myeloid leukemia."

Key Corporate Highlights

Re-initiation of Dosing in Phase 1b Clinical Study of APTO-253 – Aptose announced in November 2018 that dosing had begun in the APTO-253 clinical trial in patients with relapsed or refractory hematologic malignancies. APTO-253 is the only known clinical-stage molecule that can directly inhibit expression of the MYC oncogene, shown to reprogram survival signaling pathways and contribute to drug resistance in many malignancies, including acute AML. APTO-253 is being administered once weekly, over a 28-day cycle, and the study is expected to enroll up to 20 patients with relapsed or refractory AML and high-risk MDS patients. The study is designed to then transition to single-agent expansion cohorts in AML and MDS, followed by combination studies.

CG-806 IND Filed – In February 2019, Aptose submitted an Investigational New Drug (IND) application for CG-806 to the U.S. Food and Drug Administration (FDA) requesting approval to initiate its Phase 1 clinical trial program. CG-806 is an oral, first-in-class small molecule inhibitor of all known forms of FLT3 and BTK kinases being developed for the treatment of patients with select hematologic malignancies, including CLL/SLL and non-Hodgkin’s lymphomas, as well as for patients with relapsed/refractory AML and MDS. In preclinical studies, Aptose and collaborators demonstrated that CG-806 potently inhibits all known forms of FLT3 and BTK and suppresses key oncogenic processes essential for cancer cell survival but with a precision that spares targets and pathways associated with toxicity.

New CG-806 Data at ASH (Free ASH Whitepaper) – New preclinical data on CG-806 were presented in two separate poster presentations at ASH (Free ASH Whitepaper) in December 2018. Researchers from The University of Texas MD Anderson Cancer Center explored the mechanism by which CG-806 overcomes the emergence of resistance common to other FLT3 inhibitors (FLT3i). The authors concluded that CG-806 may overcome FLT3i-resistance in AML through the simultaneous inhibition of FLT3, BTK and autophagy signaling, and that CG-806 represents an agent that may prevent or overcome FLT3 inhibitor resistance in AML patients. Oregon Health & Science University (OHSU) researchers presented data demonstrating that CG-806 exhibited broad ex vivo potency on bone marrow cells from patients with diverse hematologic malignancies, and bioinformatic analyses revealed an unexpected ex vivo potency of CG-806 on bone marrow cells from AML patients with IDH1 mutations or with FLT3-ITD mutations. The OHSU group also demonstrated superior potency of CG-806 relative to the covalent BTKi ibrutinib (the current standard of care) on bone marrow cells from patients with CLL or other B-cell cancers. In addition, CG-806 demonstrated a favorable safety profile in all GLP toxicology and safety studies.
A summary of the results of operations for the years ended December 31, 2018 and 2017 is presented below:

Year ended December 31,
(in thousands) 2018 2017

Revenues $ — $ —
Research and development expenses 18,733 6,274
General and administrative expenses 10,374 5,552
Total other income 239 183
Net loss (28,868 ) (11,643 )
Other comprehensive loss — 18
Total comprehensive loss (28,868 ) (11,661 )
Basic and diluted loss per common share $ (0.86 ) $ (0.52 )

The net loss for the year ended December 31, 2018 was $28.9 million, an increase of $17.2 million compared with $11.7 million for the prior year. The increase is primarily a result of $5.0 million in license fees paid to CrystalGenomics Inc. (CG) for development and commercial rights of CG-806, higher research and development expenses related to our CG-806 and APTO- 253 programs, higher professional fees related to regulatory filings in support of financing activities, and from $4.3 million in non-cash expenses related to stock-based compensation. Excluding the $5.0 million one-time upfront license fees payments, the net loss for the year ended December 31, 2018 would have been $23.9 million ($0.71 per share).

Research and Development

The research and development expenses for the years ended December 31, 2018 and 2017 are as follows:

Year ended December 31,
(in thousands) 2018 2017

License fees – CG-806 $ 5,000 $ —
Program costs – CG-806 6,119 2,245
Program costs – APTO-253 4,490 2,328
Personnel expenses 2,063 1,451
Stock-based compensation 1,026 214
Depreciation of equipment 35 36
18,733 6,274

Research and development expenses for the year ended December 31, 2018 were $18.7 million, an increase of $12.4 million compared with $6.3 million for the prior year. The increase is primarily as a result of the following events:

License fees paid in the year ended December 31, 2018 to CG of $2.0 million for development and commercial rights of CG-806 in all territories outside of Korea and China, and a further $3.0 million paid for development and commercial rights of CG-806 in China. CG is eligible for development, regulatory and commercial-based milestones as well as royalties on future product sales.
An increase in research and development activities related to our CG-806 development program. In the year ended December 31, 2018, we completed two dose range finding studies and the manufacturing of a batch of the drug substance to be used in toxicity studies, we initiated the manufacturing of a GMP batch of the drug substance for future clinical trials, we completed the manufacturing of GMP batch of drug substance and completed several toxicity studies in rodents and dogs to prepare to bring CG-806 to the clinic. In the comparative periods, activities related to our CG-806 program included mostly formulation and PK studies.
An increase in expenditures on the APTO-253 program. In the year ended December 31, 2018, we completed production of a GMP batch of drug product, we completed necessary studies required for the FDA, we initiated the manufacturing of an additional clinical batch of APTO-253, we increased clinical activities in preparation to return APTO-253 to the clinic, we manufactured additional API, and initiated three clinical sites and began dosing our first patient. In the comparative periods, we were conducting root cause analysis to determine the cause of a manufacturing issue that had resulted in the program being on clinical hold.
An increase in personnel expense mostly related to additional clinical research staff hired to prepare for returning APTO-253 to the clinic and to preparing CG-806 for clinical studies.
An increase in stock-based compensation related mostly to approximately 462 thousand stock options granted to clinical operations and research employees in the three months ended March 31, 2018, of which 100,000 with a grant date fair value of $2.03 per share vested immediately. In addition, stock-based compensation is higher because of 50,000 restricted share units issued in July 2018 with a three-month vesting term and a grant date fair value of $3.35 per share.
General and Administrative

The general and administrative expenses for the years ended December 31, 2018 and 2017 are as follows:

Year ended December 31,
(in thousands) 2018 2017

General and administrative, excluding non-cash items $ 6,471 $ 4,900
Shares issued pursuant to Aspire 2018 Purchase Agreement 600 —
Stock-based compensation 3,250 602
Depreciation of equipment 53 50
10,374 5,552

General and administrative expenses for the year ended December 31, 2018 were $10.4 million, an increase of $4.8 million compared with $5.6 million for the prior year. The increase is primarily as a result of the following:

General and administrative expenses, excluding non-cash items, increased primarily as a result of higher professional fees related to regulatory filings in support of financing activities, higher investor relations costs, higher patent fees associated with our expanded IP portfolio, and higher office administrative costs associated with additional employees to support increased operations of the Company.
In June 2018, we issued 170,261 shares to Aspire Capital as a commitment fee for entering into the 2018 Purchase Agreement, as further described above under "Liquidity and Capital Resources, Common Shares Purchase Agreements." We recorded $600 thousand in general and administrative expenses related to the issuance of these shares.
Stock-based compensation increased in the year ended December 31, 2018, compared with the year ended December 31, 2017, mostly related to approximately 1.6 million stock options granted to directors, executive officers and general and administrative employees in the three-month period ended March 31, 2018, of which 750,000 with a grant date fair value of $2.03 vested immediately, and also as a result of large forfeitures in the three months ended March 31, 2017. In addition, stock-based compensation is also higher in the current period related to 100,000 restricted share units issued to executive officers in July 2018 with a three-month vesting term and a grant date fair value of $3.35.

On March 12, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes, reported that the Company will participate in the 31st Annual ROTH Conference to be held March 17-19, 2019 at the Ritz Carlton Laguna Niguel in Orange County, CA (Press release, Onconova, MAR 12, 2019, View Source [SID1234534298]).

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Steven M. Fruchtman, MD, President & CEO, and Mark Guerin, CFO, will attend the conference and be available to meet with investors. Dr. Fruchtman will also participate on a panel to discuss myeloid diseases on Monday, March 18th, from 3:00-4:00p.

On March 12, 2019 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer and other indications, reported its cash position for the fiscal year ended December 31, 2018 and provided an update on the Company’s recent and future developments (Press release, Pieris Pharmaceuticals, MAR 12, 2019, View Source [SID1234534237]).

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”2018 was an important year for the development of our two core franchises: respiratory diseases and immuno-oncology. On the respiratory front, we announced that PRS-060, an inhaled IL-4 receptor alpha antagonist for moderate-to-severe asthma that we are developing with AstraZeneca and our first respiratory program to enter the clinic, was safe and well-tolerated in healthy volunteers in a single ascending dose phase 1 study. We also initiated a multiple ascending dose phase 1 study of PRS-060 in mild asthmatics, in addition to launching discovery efforts for two proprietary respiratory programs and two additional respiratory programs as part of the AstraZeneca collaboration. On the immuno-oncology front, we continue to enroll and dose patients in the phase 1 dose-escalation study of PRS-343, a 4-1BB/HER2 bispecific for HER2-positive solid tumors, and the phase 1 combination study of PRS-343 with atezolizumab. We also advanced PRS-344, a PD-L1/4-1BB bispecific drug candidate we are developing with Servier, into IND-enabling studies and plan to file an IND application for that program later this year,” said Stephen S. Yoder, President and CEO of Pieris. ”We believe that the tireless effort of our team and partners across our clinical and preclinical pipeline last year has created an opportunity for many catalysts this year.”

PRS-060: Pieris continues to enroll subjects with mild asthma and elevated levels of fractional exhaled nitric oxide (FeNO) in a multiple ascending dose phase 1 study of PRS-060, an inhaled IL-4 receptor alpha antagonist for moderate-to-severe asthma. This study is evaluating the safety, tolerability and FeNO-reducing potential of PRS-060 versus placebo. The data from the PRS-060 phase 1 studies will be presented at upcoming medical meetings, including detailed data from the PRS-060 phase 1 single-ascending dose study, for which the Company reported topline data last year. PRS-060 is the lead candidate in Pieris’ respiratory collaboration with AstraZeneca. Pieris is sponsoring the phase 1 studies and AstraZeneca is funding the costs. Assuming successful completion of the ongoing phase 1 study, AstraZeneca would sponsor and fund the phase 2a study, after which Pieris will have options to co-develop and, subsequently, to co-commercialize the drug candidate.
Respiratory Pipeline: Pieris initiated an additional discovery-stage program in its alliance with AstraZeneca in the fourth quarter, bringing the total number of active programs to three; AstraZeneca may initiate up to two additional programs within the alliance. The Company also continues to advance the two proprietary discovery-stage respiratory programs initiated last year and intends to initiate additional proprietary respiratory programs in 2019.
PRS-343: Pieris continues to enroll and treat patients in a phase 1 dose-escalation study of PRS-343, a 4-1BB/HER2 bispecific for HER2-positive solid tumors, and intends to report comprehensive data from the study later this year. The Company also continues to enroll the dose-escalation phase 1 study of PRS-343 in combination with atezolizumab and intends to report data from this trial later this year.
PRS-344: Pieris has exercised its opt-in right to co-develop and retain U.S. rights for PRS-344, a PD-L1/4-1BB antibody-Anticalin bispecific molecule, and achieved two preclinical milestones as part of the development of the drug candidate, receiving milestone payments totaling €2.0 million from Servier. In collaboration with Servier, Pieris plans to file an IND application for the candidate this year. PRS-344 is one of five bispecific programs that Pieris is developing as part of its immuno-oncology alliance with Servier and is the first program within the alliance scheduled to enter clinical development.
Seattle Genetics Collaboration: Pieris has generated and characterized the first tumor-targeting bispecific for further evaluation and development by Seattle Genetics as part of the companies’ three-program immuno-oncology collaboration.
PRS-080: Pieris has completed dosing all patients in the phase 2a multiple ascending dose study of PRS-080, a half-life-optimized hepcidin antagonist for anemia. This study is intended to evaluate the safety, tolerability, and pharmacological activity of 5 once-weekly doses of PRS-080 as well as the effect of repeated dosing on hemoglobin levels in this patient population. Pieris intends to present the full data set from this study in the first half of 2019. In addition, following delivery of a final study report, ASKA will decide whether to exercise its option to develop and commercialize PRS-080 in Japan and other Asian territories.
Cash Position: Cash, cash equivalents and investments totaled $128.1 million as of December 31, 2018, compared to a cash, cash equivalents and investments balance of $82.6 million as of December 31, 2017. The increase was driven primarily by the $47.2 million in net proceeds from the Company’s February 2018 equity financing, the $30.0 million in upfront payments received as part of the Seattle Genetics immuno-oncology collaboration, and the $12.5 million milestone payment from AstraZeneca that was triggered during the fourth quarter of 2017 and received during the first quarter of 2018.
Additional Financials: Our 2018 full-year audited financials will be released with our Annual Report on Form 10-K, expected to be filed by Monday, March 18, 2019.
Conference Call:

Pieris management will host a conference call beginning at 8:00 AM Eastern Daylight Time on Tuesday, March 12, 2019, to provide a corporate update. Individuals can join the call by dialing +1-877-407-8920 (US & Canada) or +1-412-902-1010 (International). An archived replay of the call will be available by dialing +1-877-660-6853 (US & Canada) or +1-201-612-7415 (International) and providing the Conference ID #: 13661472.