On March 22, 2019 WuXi AppTec Co., Ltd. (stock code: 603259.SH / 02359.HK), a leading global pharmaceutical and medical device open-access capability and technology platform company with global operations, reported its audited annual results for the year ended December 31, 2018 today (Press release, WuXi AppTec, MAR 22, 2019, View Source [SID1234534573]).

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All financials disclosed in this press release are prepared based on International Financial Reporting Standards (or "IFRS").

Financial Highlights

Strong revenue growth of 23.8% year-over-year to RMB9,614 million. Applying a constant exchange rate, revenue grew 25.4% to RMB9,739 million. We continued to enhance capabilities and build capacity across all segments, while investing in the latest technologies to expand our service offering. We particularly benefited from a surging increase in business from China-based customers, and biotech customers globally.
Gross profit grew 16.6% year-over-year to RMB3,777 million. Gross profit margin was 39.3%.[1] Excluding the impact of foreign exchange loss, gross profit margin was 39.9%.
Net profit attributable to owners of the Company increased 84.2% year-over-year to RMB2,261 million, due to strong operations execution coupled with an extraordinary gain of RMB616 million from the fair value change of our investment portfolio.
Adjusted non-IFRS net profit attributable to owners of the Company grew 23.3% year-over-year to RMB1,742 million.
Diluted EPS and adjusted non-IFRS EPS increased by 70.0% and 13.9%, respectively.
Operational Highlights

We acquired 1,400+ new customers, and our active customers count reached 3,500+. – All of the top 20 global pharmaceutical companies are our customers. – We achieved 100% retention rate for our top 10 customers. – We continue to expand our biotech customer base rapidly as our integrated R&D platform enables them to efficiently and effectively discover and develop products.
For our success-based drug discovery services, in 2018 we filed 27 new-chemical-entity INDs for our customers with the NMPA (China National Medical Products Administration) and obtained 17 CTAs (clinical trial approval). As of December 31, 2018, we have cumulatively submitted 55 new-chemical-entity IND filings with NMPA for our customers and obtained 34 CTAs.
Our small molecule CDMO/CMO segment provided services to 650+ projects, including 40 in Phase III clinical trials and 16 that have been commercialized.
We became the first CMO services provider under China’s newly implemented MAH (Market Authorization Holder) policy and began commercial manufacturing services for two products, including: Ganovo, developed by Ascletis Pharma for treatment of Hepatitis C and Elunate, developed by Hutchison MediPharma for treatment of colorectal cancer.
In the highly-specialized field of cell and gene therapy, we provided CDMO services for 30 clinical stage cell and gene therapies projects; 25 in phase I and 5 in phase II/III.
Our fast growing clinical research services business helped one multinational company’s PD-1 antibody obtain market approval in China. We also helped a domestic company’s break-through drug obtain market approval for the treatment of colorectal cancer. In addition, we helped the BLA submission of the first CD20 biosimilar product in China.
In July 2018, we acquired an Austin, Texas based clinical research CRO WuXi Clinical Development, Inc. (carrying on business as ResearchPoint Global). This acquisition has allowed us to expand our global clinical trial service offering to both China based companies and US based companies for their global clinical development.
To support future growth, we are significantly expanding capacity including: chemistry laboratory expansion in our Tianjin site and new Qidong site; new cell and gene therapy GMP facilities in our Philadelphia site and Wuxi Jiangsu site; API GMP manufacturing facilities in our Changzhou site; a new medical device testing laboratory in Suzhou, and a new biology research laboratory in San Diego, California.
Management Comments

"2018 was an incredible year for the global healthcare industry and a fantastic one for our company," said Dr. Ge Li, Chairman and CEO. "The industry experienced significant progress as new innovative drugs address increasingly complex indications with remarkable results. And with the drug approval timeline greatly accelerated, the number of new drugs approved for market in the United States and in China has reached a record high. We were proud to see that 39 out of the 59 new drugs approved by the FDA came from our customers and we are committed to continually investing in our capabilities and capacity to consistently provide the highest level of service in this rapidly-changing environment."

"We are grateful to our investors who continue to believe in our vision. The capital they provide drives our growth reinforcing the confidence they have in our management team and our business model. In May and December of 2018, we successfully listed on the Shanghai Stock Exchange and the Main Board of the Hong Kong Stock Exchange, respectively."

"Our ‘Follow the Project / Follow the Molecule / Follow the Customer’ strategy continues to deliver stellar results. All along, we continued to successfully execute on our business plan achieving revenue of RMB9,614 million, representing growth of 23.8% year-over-year. Applying a constant exchange rate, our revenue grew 25.4% to RMB9,739 million. Revenue growth was broad-based across all business segments; especially our China-based laboratory services, CDMO/CMO services and clinical research and other CRO services. In addition to investments in our operations, i.e. new talent, new laboratories and facilities, our unique ecosystem that we are relentlessly building provided additional opportunities for us to effectively put our capital to use laying the foundation for future growth."

"WuXi AppTec is committed to enable innovation worldwide, catalyzing and benefiting from the continuous transformation of the healthcare ecosystem," Dr. Li continued. "Once the platform boasts enough scale and depth, the long tail effects will be truly dramatic. Looking forward, we are now entering an unprecedented golden age with the healthcare ecosystem emerging, where an ever-increasing number of participants are able to play a role at different stages of innovation. Through our integrated platform, more and more institutions, scientists, hospitals, and doctors will realize their dreams of innovation. In doing so, we will undoubtedly help bring vital medicine to patients faster."

Full-Year 2018 IFRS Results

2018 revenue increased 23.8% year-over-year to RMB9,614 million. Applying a constant exchange rate, revenue increased 25.4% year-over-year to RMB9,739 million. – Our China-based laboratory services revenue increased 24.1% year-over-year to RMB5,113 million. We fully leveraged our platform to attract more customers, especially "long-tail" customers, while expanding services to our existing customers. – We grew our CDMO/CMO services revenue 28.0% year-over-year to RMB2,699 million by diligently executing our "follow the molecule" strategy. As our customers’ projects move into late stage, we progress alongside of them by providing process validation services all the way through to commercial manufacturing services. – Our US-based laboratory services revenue increased 6.1% year-over-year to RMB1,204 million. Revenue growth was driven by our cell and gene therapies CDMO services and partially offset by a decline in medical device testing services. Cell and gene therapies CDMO services revenue grew 7.5% and 28.4% in the first half of 2018 and second half of 2018, respectively. – Our clinical research and other CRO services revenue increased 64.2% year-over-year to RMB585 million. Revenue growth was mainly driven by the substantial increase of the domestic drug clinical trial market as well as significant improvement of our services in terms of quality, scale and capabilities. – Across all segments, we benefitted from the rapid rise of pharmaceutical innovation in China experiencing 55.5% year-over-year revenue growth from China-based customers.
2018 gross profit increased 16.6% year-over-year to RMB3,777 million. Gross profit margin was 39.3%, slightly lower than 41.7% in 2017[2] primarily due to a decrease in gross profit of US-based laboratory services and RMB appreciation against USD in the first half of 2018. Applying a constant exchange rate, the gross profit margin would be 39.9%.
2018 IFRS net profit attributable to owners of the Company increased 84.2% year-over-year to RMB2,261 million. We experienced significant synergies across business segments by fully leveraging the strength of our "integrated end-to-end" R&D services platform. In addition, we experienced an extraordinary gain of RMB616 million from the fair value change of our investment portfolio.
Full-Year 2018 Non-IFRS Results

2018 non-IFRS net profit attributable to owners of the Company increased 75.5% year-over-year to RMB2,464 million. This excludes RMB46 million share-based payments, RMB22 million listing expenses for the offering of our A shares and H shares, RMB116 million foreign exchange-related losses and RMB19 million amortization of intangible assets acquired.
Full-Year 2018 Adjusted Non-IFRS Results

Excluding a further RMB750 million realized and unrealized gains from our venture investments and RMB28 million losses from our joint ventures, 2018 adjusted non-IFRS net profit attributable to owners of the Company increased 23.3% year-over-year to RMB1,742 million in 2018.
[1] If prepared under Accounting Standard for Business Enterprises of PRC, the gross profit grew 16.8% year over year to RMB 3,793 million. Gross profit margin was 39.5%.

[2] If prepared under Accounting Standard for Business Enterprises of PRC, 2018 gross profit increased 16.8% year-over-year to RMB 3,793 million. Gross profit margin was 39.5%, slightly lower than 41.8% in 2017.

On March 22, 2019 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, reported that the Company will report full year 2018 financial and operating results on the evening of Thursday, March 28, 2019 (Press release, Celyad, MAR 22, 2019, https://www.celyad.com/en/news/celyad-to-announce-full-year-2018-financial-results-and-host-conference-call [SID1234534556]).

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Following the press release, Celyad management will host a conference call on Friday, March 29 at 1p.m. CET / 8a.m. EDT to discuss full year 2018 results and provide an update on the Company’s recent progress and upcoming milestones.

Participants may access the conference call by dialing +44 (0) 2071 928000. The conference ID for the call is 8745558. Alternatively, participants may access the conference call by dialing the following local numbers: Belgium 024009874, France 0176700794, Netherlands 0207143545 and U.S. 16315107495.

To access the subsequent archived recording, visit the "Events & Webcasts" section of the Celyad website.

On March 22, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that Janssen Pharmaceutica NV (Janssen) has submitted a Type II variation application to the European Medicines Agency (EMA) (Press release, Genmab, MAR 22, 2019, View Source [SID1234534557]). The application seeks to broaden the existing marketing authorization for daratumumab (DARZALEX) to include use in combination with lenalidomide and dexamethasone (Rd) as treatment for newly diagnosed multiple myeloma patients who are not candidates for high dose chemotherapy and autologous stem cell transplant (ASCT) . The submission is based on data from the Phase III MAIA study of daratumumab in combination with Rd as treatment for patients with newly diagnosed multiple myeloma, who are not candidates for high dose chemotherapy and ASCT. Data from the study was presented at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which took place in San Diego, California in December 2018. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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"At Genmab we’re committed to improving the lives of patients by creating and developing innovative antibody products. With this potential label expansion, we are hopeful that DARZALEX will become available to an even wider group of multiple myeloma patients in the first line setting," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About the MAIA (MMY3008) study
The Phase III study (NCT02252172) is a randomized, open-label, multicenter study that includes 737 newly diagnosed patients with multiple myeloma who are not candidates for high dose chemotherapy and ASCT. Patients were randomized to receive either daratumumab in combination with lenalidomide (an immunomodulatory drug) and dexamethasone (a corticosteroid) or lenalidomide and dexamethasone alone. In the daratumumab treatment arm, patients received 16 milligrams per kilogram (mg/kg) weekly for first 8 weeks (Cycles 1 and 2), every other week for 16 weeks (Cycles 3 to 6) and then every 4 weeks (Cycle 7 and beyond) until progression of disease or unacceptable toxicity. Lenalidomide is administered at 25 mg orally on days 1 through 21 of each 28-day cycle, and dexamethasone was administered at 40 mg once a week for both treatment arms. Participants in both treatment arms will continue Rd until disease progression or unacceptable toxicity. The primary endpoint of the study is PFS.

About multiple myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the U.S., after leukemia and lymphoma.2 Approximately 26,000 new patients were expected to be diagnosed with multiple myeloma and approximately 13,650 people were expected to die from the disease in the U.S. in 2018.3 Globally, it was estimated that 160,000 people were diagnosed and 106,000 died from the disease in 2018.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5

About DARZALEX(daratumumab)
DARZALEX (daratumumab) injection for intravenous infusion is indicated in the United States in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.6 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for treatment of adults with relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).6,7,8,9,10

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and frontline multiple myeloma settings and in amyloidosis. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases, such as NKT-cell lymphoma, B and T-ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA, for multiple myeloma, as both a monotherapy and in combination with other therapies.

On March 21, 2019 In an article published today by SAGE Publishing, investigators from The Nagourney Cancer Institute and The Albert Einstein Israelite Hospital in São Paulo, Brazil, reported a new approach to identifying effective treatments for patients with advanced metastatic cancers (Press release, Nagourney Cancer Institute, MAR 21, 2019, View Source [SID1234534558]). A drug commonly used to treat kidney and liver cancer was discovered effective for breast cancer, which may open new drug therapies to patients regardless of tumor type. The full article can be found at View Source

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The study reports the use of 3-dimensional-human-tumor derived organoids that were isolated directly from a patient’s drug resistant breast cancer. The drug identified, sorafenib (Nexavar), is widely used for the treatment of kidney and liver cancers but has not been found active, used, nor approved for patients with breast cancer.

"The finding of sorafenib activity was unexpected," said Dr. Robert Nagourney, one of the authors of the paper and the director for the laboratory where the studies were conducted.

When the patient with disease that had spread throughout her body had a near complete remission with only two months of oral therapy, a remission that lasted for over a year, the researchers examined possible mechanism for the response and believe that it reflects an entirely new form of cancer cell death known as "ferroptosis." This iron-mediated process of cancer cell death is uniquely activated by sorafenib.

"Of the many targeted drugs that we tested on the cancer cells from a woman who had few options remaining, it was only sorafenib that had this effect, prompting our colleagues in São Paulo to begin therapy immediately," said Dr. Nagourney. "We are fortunate to have fantastic collaborators in Brazil who tested this therapy to such good effect."

The results could not have been more dramatic as the patient showed compete metabolic response by PET/CT only weeks later.

"We are witness to a new concept in cancer medicine where drugs can be identified and selected for individual patients in the laboratory regardless of the tumor type, that is, breast versus kidney versus lung. Drugs do not know what disease for which they were invented," he added.

The drug selection technique employed by Dr. Nagourney was developed by scientists in his laboratory in California. It uses fresh biopsies removed directly from patients to study each cancer patient’s biology to select from amongst dozens of drugs and combinations, those that will work the best. This is but one more example of what is known as repurposing drugs, allowing physicians to outsmart cancers by going around their defenses.

"It is the availability of the EVA/PCD testing platform that for this first time is making it possible to make rational drug choices for cancer patients based upon each individual’s unique features," Nagourney concluded.

On March 21, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, reported its financial and operational results for year ending December 31, 2018 (Press release, IMV, MAR 21, 2019, View Source [SID1234534539]).

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"IMV made significant advances in 2018," said Frederic Ors, Chief Executive Officer. "Foundational changes, including shifting the name of the corporation to IMV and listing on Nasdaq, are enabling us to access to a larger pool of investors and allow us to better communicate our value proposition globally. However, the evolution of our clinical program is an even more important accomplishment: we entered into a collaboration with Merck across five tumor types; opted, based on DECIDE clinical data, to pursue DPX-Survivac as a monotherapy in ovarian cancer; and published studies clearly demarcating the T cell-activating novel mechanism of action of our DPX platform. With these milestones achieved, we are looking forward to a strong 2019 in which we will continue to advance our pipeline, drive value for investors, and support unmet patient needs."

IMV will host a conference call and webcast tomorrow at 8 a.m. ET. The dial-in number for the conference call is (844) 461-9932 (U.S. and Canada) or (636) 812-6632 (international) using the conference ID: 9647179. A live audio webcast will be available through IMV’s website on the ‘Events and Presentations’ page at View Source The webcast will be recorded and available on the IMV website for 30 days following the call.

Recent Clinical Updates & Expected Milestones

Phase 1b/2 DPX-Survivac monotherapy and combination trial in ovarian cancer (DECIDE)

The first 13 patients with advanced recurrent ovarian cancer have been enrolled in the phase 2 portion of the study. Six patients were randomized on DPX-Survivac monotherapy and seven were randomized on the DPX-Survivac/epacadostat combination. The Corporation is planning to provide an update on the preliminary clinical data by the end of Q1 2019.

Enrollment of an additional 15 patients in a population with lower tumor burden is ongoing and the corporation is planning to provide another clinical update on this cohort in Q2 2019.

Phase 2 Study in Combination with KEYTRUDA in Relapsed/Refractory DLBCL (SPIREL)

Seven patients have been enrolled and treated across four different clinical sites in Canada. Additional patients are being screened and IMV expects to report updated clinical data in Q2 2019.

Phase 2 Basket Trial in Combination with KEYTRUDA in Multiple Solid Tumors

Screening and enrollment of patients is ongoing at multiple clinical sites across the U.S. and Canada for patients with bladder, liver (hepatocellular carcinoma), ovarian, or non-small cell lung (NSCLC) cancers as well as tumors shown to be positive for the microsatellite instability high (MSI-H) biomarker. The first patients have been dosed in the ovarian and lung cancer cohorts. IMV expects to report preliminary clinical results on several of the solid tumor indications before the end of 2019.

2018 Highlights

Clinical Programs – DECIDE1/2 Advanced Ovarian Cancer Trial

Updated Phase 1b data shared via an oral presentation at the 2018 ASCO (Free ASCO Whitepaper) Meeting and topline data from the first two Phase 1b dosing cohorts highlighted at the 2018 ESMO (Free ESMO Whitepaper)-IO Meeting
Based on these data, IMV opted to develop DPX-Survivac as a monotherapy in certain ovarian cancer patients defined by BTB (baseline tumor burden), an indication of tumour size
Additional analyses were conducted that correlated DPX-Survivac’s novel MOA – the level of T cell infiltration – with clinical response
Met with the U.S. Food and Drug Administration (FDA) and submitted an updated DECIDE trial protocol; in addition, IMV discussed with the FDA the need for accelerated approvals in advanced ovarian cancer and received guidance on clinical design considerations for different lines of therapy and platinum-sensitive and resistant patients
Additional Clinical Highlights

First clinical data obtained from the combination of DPX-Survivac and mCPA with Keytruda (SPIREL Trial), which came from an investigator-sponsored phase 2 trial in patients with persistent or recurrent/refractory DLBCL; data from the combination signaled significant anti-cancer activity in three of the first four evaluable patients as well as a tolerable safety profile
Announced a collaboration with Merck in a phase 2 basket trial evaluating the safety and efficacy of DPX-Survivac, low-dose cyclophosphamide, and Keytruda (pembrolizumab) in patients with select advanced or recurrent solid tumors across five different indications: bladder, liver (hepatocellular carcinoma), ovarian, or non-small cell lung (NSCLC) cancers as well as tumors with the microsatellite instability high (MSI-H) biomarker
R&D Milestones

Research published in the Journal of Biomedical Science demonstrated the association between IMV’s proprietary immune-targeted delivery technology and enhanced efficacy in slowing tumor progression
New data presented at the 2018 AACR (Free AACR Whitepaper) Meeting highlighted the novel MOA underscoring the Corporation’s T cell-activating DPX technology and the potential for heightened anti-cancer activity of combination therapies based on IMV’s proprietary delivery platform
Operational Highlights:

Completion of two public offerings: In February 2018 and in March 2019 for a total of approximately $43.9 million
Nasdaq listing and share consolidation: IMV’s common shares commenced trading on the Nasdaq Stock Market LLC on June 1, 2018
Corporate name change: Because the MOA of DPX-based candidates signals a new class of immunotherapies that is differentiated from vaccines, IMV leadership changed the corporation’s name from Immunovaccine to IMV to better reflect the true potential of its therapeutic candidates
Addition of Julia P. Gregory and Dr. Markus Warmuth to the Corporation’s Board of Directors: Ms. Gregory is a seasoned biotechnology executive, having served as Chief Executive Officer and of ContraFect Corporation and the immuno-oncology company Five Prime. Dr. Warmuth brings to the Board more than 20 years of drug discovery experience with a strong focus on targeted therapy and immuno-oncology programs
Expansion of management team: IMV named Joseph Sullivan as the Corporation’s first Senior Vice-President, Business Development. Mr. Sullivan brings with him over 25 years of global pharmaceutical experience with Merck & Co. Inc. to IMV
Opening of new facility in Dartmouth, Nova Scotia: Nearly tripling the functional workspace, the new premises feature upgraded facilities and equipment as well as increased laboratory size to support long-term growth
Cash position: As of December 31, 2018, cash and cash equivalents and short-term investments were $14.9 million (excluding the $29.5 million financing completed in March 2019) compared to $14.9 million as of December 31, 2017
Overview of Year-End 2018 Financial Results

The net loss and comprehensive loss of $21,935,000 ($0.50 per share) the year ended December 31, 2018 was $9,908,000 higher than the net loss and comprehensive loss for the year ended December 31, 2017.

Research and development expenses increased by $6,914,000 for the year ended December 31, 2018, compared to 2017. These increases are mainly due to higher enrollment in the phase 1b/2 Incyte trial in ovarian cancer; milestone payments for the phase 2 study in DLBCL; and expenses related to the initiation of the basket trial. The increase is also attributable to manufacturing activities to support the increased clinical activity, which included purchasing raw materials and contract manufacturing organization costs.

General and administrative expenses increased by $2,039,000 for the year ended December 31, 2018 compared to 2017. This increase is mainly due to the various expenses related to the Nasdaq listing (legal, audit and consulting fees as well as listing fees) that are non-recurring expenses, the filing of a shelf prospectus, the increase in insurance premiums following the Nasdaq listing, consulting and professional fees, regulatory fees, the increase of the rent, lease interest accretion, and utilities related to the new facility.

Business development and investor relations expenses increased by $781,000 for the year ended December 31, 2018 compared to 2017. These increases are mainly explained by the hiring of a Senior Vice President, Business Development in January 2018 and a Senior Director of Investor Relations and Communications in November 2018.

At December 31, 2018, the Corporation had cash and cash equivalents of $14,895,000 (excluding the $29.5 million financing completed in March 2019) and working capital of $12,247,000, compared with $14,909,000 and $13,627,000, respectively at December 31, 2017. For the year ended December 31, 2018, IMV’s cash burn rate, defined as net loss for the period adjusted for operations not involving cash (interest on lease obligation, depreciation, accretion of long-term debt, stock-based compensation and DSU compensation), was $18.4 million. IMV expects research and development expenditures to increase over time due to the continuing development of product candidates and other clinical, preclinical, and regulatory activities.

As of March 21, 2019, the number of issued and outstanding common shares was 50,594,260 and a total of 2,008,057 stock options, warrants, and deferred share units were outstanding.

The Corporation’s audited annual consolidated results of operations, financial condition and cash flows for the year ended December 31, 2018 and the related management’s discussion and analysis (MD&A) are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.