On March 28, 2018 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company") a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, reported its financial results and business highlights for the fourth quarter and full year ended December 31, 2017 (Press release, Cyclacel, MAR 28, 2018, View Source [SID1234525036]).The Company’s net loss applicable to common shareholders for the three months and year ended December 31, 2017 was $2.1 million and $14.9 million, respectively. As of December 31, 2017, cash and cash equivalents totaled $23.9 million.

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"We are greatly encouraged by our clinical progress in 2017, particularly in our transcriptional regulation program with CYC065, our lead CDK inhibitor candidate," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "We have achieved clinical proof of mechanism with CYC065 by demonstrating durable reduction of Mcl-1 expression in Phase 1 patients for at least 24 hours after a single dose. We believe these unprecedented findings provide a strong rationale for evaluating CYC065 in combination with venetoclax in patients with chronic lymphocytic leukemia, or CLL, and neuroblastoma, a predominantly pediatric cancer with poor prognosis. In collaboration with an academic center and a pharmaceutical company we have developed a protocol for a Phase 1b/2 investigator-sponsored trial to evaluate combination treatment of an approved PARP inhibitor and sapacitabine in patients with BRCA mutant breast cancer. We have also completed analysis of the results from the SEAMLESS Phase 3 study of sapacitabine and plan to discuss the data with regulatory authorities. Finally, we improved our cash resources raising $14.9 million, net of expenses, which will fund currently planned programs through the first quarter of 2020. We look forward to reporting our progress during the remainder of 2018, including clinical data from our studies as they arise, such as the previously announced, oral presentation of Phase 1 data with CYC065 at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting."

Fourth Quarter and Full-Year Highlights

Drug Development

Transcriptional Regulation Program: CYC065 CDK Inhibitor

In part 1 of an ongoing, first-in-human, single agent, ascending dose, Phase 1 study, prolonged reduction of Mcl-1 was observed in 11 out of 13 evaluable patients treated at the recommended Phase 2 dose, or RP2D, following a single dose of CYC065, which was generally well tolerated. Preliminary anticancer activity was observed in 5 patients, of which 4 were treated at the RP2D and 3 were reported by investigators to have molecular features of their cancers associated with CYC065’s mechanism of action, including amplification of Mcl-1, MYC or cyclin E. The trial is being conducted at the Dana Farber Cancer Institute in Boston. Part 2 of the Phase 1 translational study will evaluate additional dosing schedules in patients with advanced solid tumors, in particular those with amplification of Mcl-1, MYC or cyclin E, including subsets of high grade serous ovarian and uterine cancers. Several biomarkers relevant to CYC065’s mechanism of action will be assessed.

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The protocol for the Phase 1b study of a combination regimen of CYC065 and venetoclax in patients with relapsed or refractory CLL has been submitted to the US Food and Drug Administration or FDA. The study will evaluate safety, pharmacokinetics and pharmacodynamics of the combination, including biomarkers related to the mechanism of action of CYC065.

Discussions with principal investigators and/or cooperative groups progressed with the objective of evaluating CYC065 in both pediatric and adult patients with solid tumors. The Company is discussing with an investigator cooperative group a potential evaluation of CYC065 in patients with neuroblastoma, a mostly pediatric, life-threatening malignancy, frequently associated with MYCN amplification.

In another study, to be conducted as an investigator sponsored trial, CYC065 will be evaluated in adult and pediatric patients with leukemias, including acute myeloid leukemia, or AML, acute lymphocytic leukemia, or ALL, and in particular those with mixed lineage leukemia rearrangements, or MLL-r.

Preclinical data on the molecular rationale and therapeutic potential of CYC065 included an article published in the Journal of National Cancer Institute, reporting prominent antitumor activity against lung cancer cells through anaphase catastrophe, a novel, cancer specific, mechanism. CYC065 was found to be effective against lung cancer cell lines, including those with KRAS mutations. Additional preclinical data presented at the 2017 AACR (Free AACR Whitepaper) Annual Meeting, demonstrated therapeutic potential of CYC065 as a targeted anticancer agent. CYC065 substantially inhibited growth, triggered apoptosis, and induced anaphase catastrophe in murine and human lung cancer cells with known high metastatic potential. This was in marked contrast to effects in immortalized pulmonary epithelial murine and human cells. CYC065 markedly inhibited migration and invasion of lung cancer cells and affected distinctive pathways involved in DNA damage response, apoptosis, cell cycle regulation and cell migration.

DNA Damage Response (DDR) Program

In collaboration with an academic center and a pharmaceutical company we have developed a protocol for a Phase 1b/2 investigator-sponsored trial to evaluate safety and efficacy of a combination regimen of an approved PARP inhibitor and sapacitabine in patients with BRCA mutant breast cancer.

Enrollment has been completed in an extension of part 1 of the Phase 1 study evaluating a combination regimen of sapacitabine and seliciclib, Cyclacel’s first generation CDK inhibitor, in an enriched population of approximately 20 patients with BRCA positive advanced breast cancer. An ongoing part 3 of this study is testing a revised dosing schedule in additional patients, including BRCA positive, patients with breast, ovarian and pancreatic cancers.

SEAMLESS Phase 3 Study

Data from the SEAMLESS Phase 3 study of sapacitabine in elderly patients with AML were the subject of an oral presentation in December 2017 at the 59th ASH (Free ASH Whitepaper) Annual Meeting. The presentation included additional data from prespecified and exploratory analysis of subgroups that may benefit from treatment with the sapacitabine-decitabine alternating regimen. The Company believes that the subgroup results have defined a patient population for whom the sapacitabine regimen may represent an improvement over low intensity treatment by decitabine alone.

The Company has completed further statistical and exploratory analyses of the results from the SEAMLESS study and is preparing briefing documents for submission to regulatory authorities with the objective of determining a potential regulatory pathway for sapacitabine in AML.

PLK1 Inhibitor; CYC140

At the 2017 AACR (Free AACR Whitepaper) Annual Meeting, the Company presented preclinical data outlining the potential therapeutic utility of CYC140, a novel, polo-like kinase (PLK) 1 inhibitor, alone and in synergistic drug combinations, for the treatment of esophageal cancer and acute leukemia.

Investigator-Sponsored Trials (ISTs): Seliciclib in Rheumatoid Arthritis (RA)

The Independent Data Monitoring Committee, or IDMC, for the "TRAFIC" trial sponsored by the UK Medical Research Council, (ISRCTN 36667085) determined that part 1 of the study was successfully completed per protocol. The IDMC recommended continuation of the trial into part 2 to assess potential efficacy of seliciclib as an addition to existing anti-TNF therapy based on a composite outcome of response in patients with moderate to severe RA.

Corporate Developments

The Company raised net proceeds of approximately $13.7 million from an underwritten offering of common stock.

Cyclacel received notice from the European Patent Office of the grant of a European patent including claims to novel pharmaceutical formulations of sapacitabine.

2018 Key Upcoming Business Objectives

·Report updated CYC065 Phase 1 data in patients with advanced cancers

·Initiate CYC065 Phase 1b in relapsed/refractory CLL in combination with venetoclax

·Start enrollment in the Phase 1b/2 IST of a combination regimen of an approved PARP inhibitor and sapacitabine in patients with BRCA mutant breast cancer

·Start enrollment in the Phase 1b/2 IST of CYC065 in pediatric patients with neuroblastoma

·Update mature data from the part 1 extension of the sapacitabine and seliciclib combination in patients with BRCA positive advanced breast and complete part 3 enrollment of the sapacitabine and seliciclib combination in patients with BRCA positive, breast, ovarian and pancreatic cancers

·Submit CYC140, PLK1 inhibitor, IND application

·Conduct regulatory authority meetings regarding the SEAMLESS study of sapacitabine in AML

Financial Highlights

As of December 31, 2017, cash and cash equivalents totaled $23.9 million, compared to $16.5 million as of December 31, 2016. The increase of $7.4 million was primarily due to net proceeds of $13.7 million from a direct registered offering, $1.0 million from the sale of common stock through the ATM sales agreement with FBR Capital Markets & Co., $0.2 million warrant exercises and offset by $7.5 million of net cash used in operating activities.

There were no revenues for the three months and year ended December 31, 2017 compared to $0.3 million and $0.8 million for the same period of the previous year. The revenue is related to previously awarded, UK government grants being recognized over the period to progress IND-directed preclinical development of CYC140, a novel, PLK-1 inhibitor, which was completed in November 2016.

Research and development expenses were $0.7 million and $4.2 million for the three months and year ended December 31, 2017 as compared to $1.9 million and $9.5 million for the same periods in 2016. The decrease was primarily due to reduced study and clinical supply costs associated with completion of the SEAMLESS study and 2016 expenditure related the development of CYC140.

General and administrative expenses for the three months and year ended December 31, 2017 were $1.5 million and $5.3 million, compared to $1.5 million and $5.5 million for the same period of the previous year.

Other income (expense), net for the three months and year ended December 31, 2017 were $0.1 million and $1.0 million, compared to ($0.1) million and $0.4 million for the same period of the previous year. The increase is primarily related to income received under an Asset Purchase Agreement with Life Technologies Corporation, or LTC, (formerly Invitrogen Corporation and subsequently acquired by ThermoFisher Scientific), resulting from certain assets and intellectual property sold by the Company to LTC in December 2005.

United Kingdom research & tax credits were $0.2 million and $1.0 million for the three months and year ended December 31, 2017 as compared to $0.4 million and $2.0 million for the same periods in 2016.

Net loss for the three months and year ended December 31, 2017 were $1.9 million and $7.5 million compared to $2.8 million and $11.8 million for the same periods in 2016.

Conference call information:

US/Canada call: (877) 493-9121 / international call: (973) 582-2750

US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406

Code for live and archived conference call is 4857905

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

On March 28, 2018 bluebird bio, Inc. (Nasdaq: BLUE) and Celgene Corporation (Nasdaq: CELG) reported that the companies have entered into an agreement to co-develop and co-promote bb2121, an investigational anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cell therapy for the potential treatment of patients with relapsed/refractory multiple myeloma in the United States (Press release, bluebird bio, MAR 28, 2018, http://investor.bluebirdbio.com/news-releases/news-release-details/bluebird-bio-and-celgene-corporation-enter-agreement-co-develop [SID1234525035]).

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This press release features multimedia. View the full release here: View Source

"Entering into this co-development and co-promotion partnership with Celgene is a significant step forward in building a fully integrated oncology franchise for bluebird and together, we are committed to rapidly advancing development of bb2121 for patients," said Joanne Smith-Farrell, Ph.D., oncology franchise leader and senior vice president, corporate development and strategy, bluebird bio. "The collaboration builds upon our extensive research and development capabilities in oncology and is a testament to the strong partnership that exists between our two companies."

The companies originally entered into a broad, global strategic research collaboration in 2013 to discover, develop and commercialize novel therapies in oncology, which included bb2121.

"We are extremely pleased to advance our collaboration with bluebird on bb2121 and we believe this therapy has the potential to significantly impact the treatment approach and outcomes for patients with multiple myeloma," said Nadim Ahmed, President, Hematology and Oncology for Celgene.

About the bluebird bio-Celgene Collaboration

bluebird bio and Celgene are collaborating to develop CAR T cell therapies targeting BCMA. The collaboration’s lead oncology program, bb2121, is currently being studied for the treatment of relapsed and refractory multiple myeloma. For bb2121, bluebird and Celgene have joint responsibility for development, manufacturing and commercialization in the United States. Celgene will assume sole responsibility for drug product manufacturing and commercialization outside the United States.

bluebird bio and Celgene are also working together on a second clinical-stage anti-BCMA CAR T program, bb21217.

On March 28, 2018 Argos Therapeutics Inc. (NASDAQ:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis precision immunotherapy technology platform, reported that it will report fourth quarter and year-end 2017 financial results and operational highlights prior to the market open on Monday, April 2, 2018 (Press release, Argos Therapeutics, MAR 28, 2018, View Source [SID1234525034]).

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On March 28, 2018 Altimmune, Inc. (Nasdaq:ALT), a clinical-stage immunotherapeutics company, reported financial results for the year ended December 31, 2017 (Press release, Altimmune, MAR 28, 2018, View Source [SID1234525033]).

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Corporate Highlights

Enrolled first two cohorts of government funded Phase 1 trial of NasoShield, an intranasal vaccine against anthrax infection
Positive data in two Phase 2 clinical programs:
Announced positive proof-of-concept Phase 2 flu vaccine trial results with our NasoVAX vaccine
Announced positive pre-clinical data from the Company’s SparVax-L trial comparing SparVax-L and BioThrax against anthrax infection
Extended its IP protection of NasoShield in the U.S. with a Notice of Allowance from the U.S. Patent Office
Elected Mitchel Sayare, Ph.D., as Chairman of its Board of Directors
Raised approximately $30 million in financing, including through a Series B preferred offering, cash acquired in connection with the reverse merger with PharmAthene and a pre-merger private placement with existing investors, providing cash into the first quarter of 2019
"We have had a very data-rich few weeks with results being reported from our NasoVAX, HepTcell, and SparVax-L programs and moving forward on enrollment in our Phase 1 trial of NasoShield," said William J. Enright, Chief Executive Officer of Altimmune. "We are very excited by the positive results from our NasoVAX trial and look forward to continuing to advance that program. NasoVAX is a very different type of flu vaccine that has tremendous potential as an effective, easy-to-use vaccine that potentially provides better protection than current vaccines. We are also excited by the results on our SparVax-L trial and look forward to moving that program forward once we secure additional government funding. We continue to evaluate our HepTcell results will update investors on our next steps as we better understand those results."

Mr. Enright continued, "Operationally, we are pleased with our progress. In 2017 we closed the reverse merger with PharmAthene, allowing us to leverage our resources and create a focused immunotherapeutics company. We strengthened our scientific team with the promotion of Dr. Sybil Tasker to Chief Medical Officer in early 2017. Additionally, in January 2018, Mitchel Sayare, Ph.D. was elected as Chairman of our Board of Directors bringing in-depth biotechnology experience as the former CEO of Immunogen. We anticipate continuing to build on our momentum in 2018 as we move forward with our NasoVAX, SparVax-L and NasoShield programs."

Financial Results for the Year Ended December 31, 2017

Revenue for the year ended December 31, 2017 was $10.7 million compared to $3.2 million for 2016. The increase was due to $5.7 million increase in revenue from our contract with BARDA and $1.8 million revenue from the NIAID contract we assumed from our merger with PharmAthene in May 2017.

Research and development expenses were $18.4 million for the year ended December 31, 2017 compared to $7.2 million for 2016. The increase in research and development expenses was primarily the result of increases relating to NasoShield, NasoVAX, HepTcell, and SparVax-L clinical and preclinical trial costs, partially offset by $0.5 million reduced spending on the Oncosyn program. Research and development expenses for the year ended December 31, 2016 did not include PharmAthene or costs incurred under the NIAID contract.

General and administrative expenses were $8.5 million for the year ended December 31, 2017, compared to $7.1 million for 2016. The increase was the combined result of increased professional fees related to the merger with PharmAthene and costs incurred by us as a public company, including insurance costs and stock compensation expense, offset by $2.4 million of costs related to our initial public offering incurred in 2016 that did not recur in 2017.

We determined that our goodwill was impaired and a non-cash goodwill impairment charge of $35.9 million was recorded during the year ended December 31, 2017 which was classified as a component of operating expenses. The non-cash charge resulted from our goodwill assessment based on our market capitalization plus an implied control premium relative to the carrying value of our net assets. The non-cash charge has no effect on our current cash balance or operating cash flows.

We recorded an income tax benefit of $5.6 million during the year ended December 31, 2017, which reflected estimated tax refunds we expect to receive from carrying back our 2017 net operating losses to offset the 2016 federal and state income taxes paid by PharmAthene.

Net loss attributable to common stockholders for the year ended December 31, 2017 was $51.4 million compared with $11.5 million for 2016. Excluding the non-cash goodwill impairment charges, net loss attributable to common stockholders for the year ended December 31, 2017 was $15.4 million compared to $11.5 million for 2016.

Net loss per share attributable to common stockholders for the year ended December 31, 2017 was ($4.01) compared with ($1.66) for 2016. Excluding the non-cash goodwill impairment charges, net loss per share attributable to common stockholders for the year ended December 31, 2017 was ($1.21), compared to ($1.66) for 2016.

At December 31, 2017, the Company had cash, cash equivalents, and restricted cash of approximately $12.3 million, of which $3.5 million was restricted under the terms of the Series B preferred offering.

Non-GAAP Measures

To supplement the Company’s unaudited financial statements presented in accordance with generally accepted accounting principles ("GAAP"), this press release includes a discussion of adjusted net loss attributable to common stockholders and adjusted net loss per share attributable to common stockholders, in each case adjusted for the loss due to a goodwill impairment charge. The Company believes that these non-GAAP measures, when taken into consideration with the corresponding GAAP financial measures, provide investors with meaningful comparisons of current results to prior period results by excluding items that the Company does not believe reflect its fundamental business performance. See the attached schedule for a reconciliation of net loss to adjusted net loss and loss per share to adjusted loss per share for the twelve months ended December 31, 2017 and 2016.

On March 28, 2018 Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) reported financial and operating results for the fourth quarter and year ended December 31, 2017 (Press release, AEterna Zentaris, MAR 28, 2018, View Source [SID1234525032]).

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All Amounts are in U.S. Dollars
Recent Key Developments

U.S. Food and Drug Administration (FDA) granted marketing approval for Macrilen

Marketing Authorization Application (MAA) for the use of Macrilen (macimorelin) for the evaluation of AGHD was accepted by the European Medicines Agency (EMA) for regulatory review

Macrilen(macimorelin) License and Assignment Agreement to Strongbridge Biopharma completed

Financial condition and capital structure improved
◦
As of December 31, 2017, we had $7.8 million of unrestricted cash and cash equivalents at year-end and no third-party debt;
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Upfront payment of $24 million received from Strongbridge in January 2018
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Approximately 16,440,760 Common Shares outstanding as of March 27, 2018

Appointment of James Clavijo as Chief Financial Officer
Commenting on recent key developments, Michael V. Ward, President and Chief Executive Officer for Aeterna Zentaris, stated,"We made a positive transformation in the fourth quarter 2017 when we pursued out-licensing to maximize shareholder value and now are focused on the flawless execution of the contractual obligations with Strongbridge. We have been working with the exceptional leadership team at Strongbridge to transition Macrilen and are on target to support their efforts to successfully launch Macrilen as early as possible."
Mr. Ward continued his commentary with an update on the development of Macrilen."We are now in a better position to maximize additional value of Macrilen by licensing in territories outside of the United States and Canada. We have continued adjustment of the operating plan in Germany and the United States to reduce non-essential expenses.

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We further enhanced our operations with the appointment of James Clavijo as Chief Financial Officer on March 5, 2018. James is highly-skilled at building effective financial systems, organization restructuring, and developing solutions leading to financial and operational improvements."

Financial Highlights
Revenues $0.9 million
Research and Development ("R&D") Costs $10.7 million
General and Administrative ("G&A") Expenses $8.2 million
Selling Expenses $5.1 million
Net Finance Costs Income $2.8 million
Income Tax Recovery $3.5 million
Net Loss $16.8 million
Working Capital $3.6 million

Fourth Quarter and Full-Year Highlights
Revenues
Sales commission and other were $0.1 million and $0.5 million for the three and twelve months ended December 31, 2017 and $0.1 million and $0.4 million for the same periods in 2016, and thus increased in 2017 as compared to 2016. In 2017, those revenues mainly resulted from our sales team exceeding pre-established unit sales baseline thresholds under our co-promotion agreement to sell Saizen. We also generated sales commission in connection with our promotion of APIFINY. In the corresponding periods in 2016, sales commission and other revenues were mainly related to EstroGel.
License fees were $0.1 million and $0.5 million for the three and twelve months ended December 31, 2017, as compared to $0.2 million and $0.5 million for the same periods in 2016.
The Company currently has deferred revenues at December 31, 2017 of $541,000 relating to non-refundable upfront payments it previously received for licensing and technology transfer arrangements that it entered into with respect to the development of Zoptrex in various territories. Due to events that occurred in 2018, the Company does not anticipate development of Zoptrex under the licensing agreements, therefore the Company’s remaining carrying amount of deferred revenues will be recognized in the first quarter of 2018 as income.
Operating Expenses
R&D costs were $0.5 million and $10.7 million for the three and twelve months ended December 31, 2017, compared to $4.6 million and $16.5 million for the same periods in 2016. R&D costs decreased for the three-month and twelve-month periods ended December 31, 2017 as compared to the same period in 2016. The decrease in R&D costs is mainly attributable to lower comparative third-party costs, as described below, partially offset by the recording, in the third quarter of 2017, of a provision in connection with the 2017 German Restructuring.
Additionally, the decrease in our R&D costs for the twelve months ended December 31, 2017, as compared to the same period in 2016, is attributable to lower employee compensation and benefits costs, lower facilities rent and maintenance

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costs as well as lower other costs. A substantial portion of this decrease is due to the realization of cost savings in connection with our ongoing efforts to streamline our R&D activities and to increase our commercial operations and flexibility by reducing our R&D staff, which was started in 2014 (the "Resource Optimization Program"). The R&D costs for the year ended December 31, 2017 were lower than anticipated mainly because we were able to negotiate reductions to a change order received from our principal R&D third-party service provider.
Third-party costs attributable to Zoptrex decreased during the three and twelve months ended December 31, 2017, as compared to the same period in 2016, mainly since we closed out the study and related activities in the second quarter following the negative Zoptrex top-line results on May 1, 2017. The negative costs for the three-month period ended December 31, 2017 are mainly explained by lower close out costs as compared to the accrual made in the second quarter.
Third-party costs attributable to Macrilen (macimorelin) decreased during the three and twelve months ended December 31, 2017, as compared to the same period in 2016. This is mainly since we completed the Phase 3 clinical trial at the end of 2016. The costs incurred in 2017 related to the detailed analysis of the top-line results as well as the preparation of the NDA filing which was submitted on June 30, 2017. The costs reversal in the fourth quarter of 2017 are explained mainly by the reductions to close out costs.
Excluding the impact of foreign exchange rate fluctuations, we expect that we will incur overall R&D costs of between $1.0 million and $2.0 million for the year ended December 31, 2018.
G&A expenses were $2.8 million and $8.2 million for both the three and twelve-month periods ended December 31, 2017, as compared to $1.8 million and $7.1 million for the same periods in 2016. The increase in our G&A costs for the three and twelve months ended December 31, 2017, as compared to the same period in 2016, is mainly due to outside legal costs. The G&A expenses are in line with expectations.
Excluding the impact of foreign exchange rate fluctuations and the recording of transaction costs related to potential financing activities (not currently known or estimable), we expect that G&A expenses will range between $9.0 million and $11.0 million in 2018.
Selling expenses were $0.5 million and $5.1 million for the three and twelve months ended December 31, 2017, as compared to $1.5 million and $6.7 million for the same periods in 2016. Selling expenses for the three and twelve months ended December 31, 2017 and 2016 represent mainly the costs of our sales force related to the co-promotion activities as well as our sales management team. The decrease in selling expenses is explained by the elimination of sales representatives. In the fourth quarter, we eliminated all sales representatives as part of the restructuring efforts. Based on currently available information, we expect selling expenses to range between $0.2 million and $0.5 million in 2018.
Other Income (Costs)
Net finance income (costs) was $(0.4) million and $2.8 million for the three and twelve months ended December 31, 2017, as compared to $(0.6) million and $4.5 million, for the same periods in 2016. The decrease in finance income is mainly attributable to the change in fair value of warrant liability. Such change in fair value results from the periodic "mark-to-market" revaluation, via the application of pricing models, of outstanding share purchase warrants. The closing price of our common shares, which, on the NASDAQ, fluctuated from $0.84 to $3.65 during the twelve-month period ended December 31, 2017, compared to $2.67 to $4.94 during the same period in 2016, also had a direct impact on the change in fair value of warrant liability.

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Net Loss
Net loss for the three and twelve months ended December 31, 2017 was $0.5 million and $16.8 million (or $0.03 and $1.12 per share), as compared to a net loss of $8.2 million and $25.0 million (or $0.71 and $2.41 per share) for the same periods in 2016. The decrease in net loss for the three-month period ended December 31, 2017 is a result of the reduction in third party R&D costs. The reduction is attributed to closing out the Zoptrex study and successful completion in the U.S. of the Macrilen (macimorelin) filing.
Liquidity
Our operations and capital expenditures have been financed through certain transactions impacting our cash flows from operating activities, public equity offerings and issuances under various ATM programs.
At December 31, 2017, we had $7.8 million of cash and cash equivalents. We expect existing cash balances and operating cash flows (including the upfront cash payment of $24 million from Strongbridge discussed below) will provide us with adequate funds to support our current operating plan for at least the next twelve months.

Conference Call
The Company will host a conference call to discuss these results on Wednesday, March 28, 2017, at 8:30 a.m., Eastern Time. Participants may access the conference call by telephone using the following dial-in numbers:

Toll-Free: 877-407-8029, Confirmation #13677806

Toll: 201-689-8029, Confirmation #13677806
A replay of the conference call will also be available on the Company’s website for a period of 30 days.
For reference, the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the fourth quarter and full year 2017, as well as the Company’s audited consolidated financial statements as at December 31, 2017, 2016 and 2015, can be found at www.aezsinc.com in the"Investors" section.