On March 13, 2018 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE American: IMUC) reported financial results for the fourth quarter and full year ended December 31, 2017 (Press release, ImmunoCellular Therapeutics, MAR 13, 2018, View Source [SID1234524734]).

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Anthony J. Gringeri, PhD, President and Chief Executive Officer commented: "We ended 2017 in a strong financial condition with approximately $6.6 million in cash and $4.6 million in both working capital and stockholders’ equity. During the fourth quarter of 2017 we received approximately $5.6 million of net proceeds from exercises of warrants issued in our July 2017 underwritten public offering, and we implemented payment programs with our key vendors, both of which contributed to a strengthening of our balance sheet. In the second half of 2017, we also reduced our expenses, and are operating in what we believe is a capital-efficient manner, which should meaningfully extend our cash runway. We believe that with our current financial plan, we may successfully be able to regain compliance with the NYSE American listing standards regarding stockholders’ equity."

Dr. Gringeri continued: "In the fourth quarter of 2017, we achieved a key milestone in our Stem-to-T-Cell research program by successfully packaging T cell receptor DNA into a viral vector and transferring that DNA into human hematopoietic stem cells. We are currently working to achieve our next milestone in this program, optimizing transfection conditions for the hematopoietic stem cells, which would then enable preclinical testing. Additionally, we are completing the wind-down of ICT-107 activities while continuing to seek partnership opportunities for our clinical-stage anticancer assets. In addition, as previously announced, we recently retained Ladenburg Thalmann & Co. Inc. as our strategic financial advisor to assist in the review of our business and assets and the exploration of strategic opportunities for enhancing stockholder value, including the potential sale or merger of the Company. It is important to remember that we cannot guarantee that this process will culminate in a transaction. Nevertheless, it is a top priority for our management and board, and we are optimistic that this next phase can identify further opportunities for creating value for ImmunoCellular stockholders."

Fourth Quarter and Full Year 2017 Financial Results

For the year ended December 31, 2017, the Company incurred a net loss of $14.3 million compared to $22.1 million in 2016. The net loss available to common stockholders for the year ended December 31, 2017, was $17.7 million, or $1.23 per basic and diluted common share, compared to $22.1 million, or $7.89 per basic and diluted common share, in 2016. The 2017 net loss available to common stockholders includes the net loss of $14.3 million, plus $2.3 million of deemed dividends and $1.0 million of original issue discount associated with the convertible preferred stock issued as part of the July 2017 financing. There were no similar charges during 2016.

The decrease in net loss between years is due to reductions in both research and development expenses and general and administrative expenses. Research and development expenses in 2017 decreased to $17.1 million from $19.1 million in the prior year. The decrease reflects the suspension of the phase 3 trial of ICT-107 in June 2017. In 2017, general and administrative expenses were $4.0 million compared to $5.0 million in 2016. Simultaneous with the suspension of the ICT -107 trial, the Company reduced the number of administrative personnel, downsized its office space and reduced other expenses. These reductions were partially offset by higher professional fees. Additionally, during 2017, the Company recognized a gain of $7.7 million related to the de-recognition of the liability resulting from advances, plus accrued interest, from the California Institute of Regenerative Medicine. In 2016, the Company recognized a gain of $3.8 million related to the revaluation of its warrant derivatives. During 2017, the Company early adopted ASU 2017-11, which allowed the Company to reclassify its warrant derivatives as equity. Accordingly, there were no gains or losses associated with warrant revaluation during 2017.

Net loss for the quarter ended December 31, 2017, was $431,000, or $0.01 per basic and diluted common share, compared to $6.3 million, or $1.36 per basic and diluted common share, for the quarter ended December 31, 2016. The decrease in the net loss is attributable to reduction in research and development associated with the suspension of the phase 3 trial of ICT-107 as well as certain discounts that the Company negotiated with key vendors.

In July 2017, ImmunoCellular completed an underwritten public offering that provided $4.0 million in net proceeds from the sale of convertible preferred stock, with the potential to secure an additional $9 million in funding over the 12 months following the closing of the financing from the exercise of warrants to purchase preferred stock issued in the financing transaction. As part of the financing, the Company issued three warrant tranches of $3 million each with maturities in October 2017, January 2018 and July 2018. Through December 31, 2017, the Company received $7.8 million in net proceeds from the exercise of warrants. The Company is using the financing proceeds to move forward with a restructuring plan focused on winding down ICT-107 activities and advancing early-stage research programs while continuing to seek partnership opportunities for development-stage assets. As of December 31, 2017, the Company had $6.6 million in cash, $4.6 million of working capital and stockholders’ equity and 41,913,256 shares of common stock outstanding.

Conference Call and Webcast Today

ImmunoCellular plans to hold a conference call and webcast today, March 13, 2018, at 5:00 pm ET to review 2017 financial results and provide a business update. The call will be hosted by Anthony J. Gringeri, PhD, President and Chief Executive Officer.

LIVE CALL:

(877) 853-5636 (toll-free); international dial-in: (631) 291-4544; conference code 4075529.

WEBCAST:

Interested parties who wish to listen to the webcast should visit the Investor Relations section of ImmunoCellular’s website at www.imuc.com, under the Events and Presentations tab. A replay of the webcast will be available one hour after the conclusion of the event.

The conference call will contain forward-looking statements. The information provided on the teleconference is accurate only at the time of the conference call, and ImmunoCellular will take no responsibility for providing updated information except as required by law.

On March 13, 2018 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, reported that on March 20, 2018, the Company will release its financial results for the quarter and year ended December 31, 2017 (Press release, , 13 13, 2018, View Source [SID1234524778]). The Company’s management team will host a conference call to discuss the Company’s financial results and recent corporate developments on Tuesday, March 20, 2018 at 8:30 a.m. ET.

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The call can be accessed by dialing one of the numbers listed below five minutes prior to the start of the call and providing the confirmation code 3160515.

United States: +1 786-789-4776

Germany: +49 (0)69 2222 13420

Netherlands: +31 (0) 20 721 9251

Denmark: +45 35 15 80 49

France: +33 (0)1 76 77 22 74

Switzerland: +41 (0)22 567 5729

United Kingdom:+44 (0)330 336 9105

An audio webcast of the conference call can be accessed in the "Events" section on the "Investors & Media" page of the Affimed website at www.affimed.com/events.php. A replay of the webcast will be available on Affimed’s website shortly after the conclusion of the call and will be archived on the Affimed website for 30 days following the call.

On March 13, 2018 Athersys, Inc. (NASDAQ:ATHX) reported its fourth quarter 2017 and annual 2017 financial results and highlights (Press release, Athersys, MAR 13, 2018, View Source [SID1234524724]).

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"As we announced today in a separate press release, we have entered a letter of intent to expand our collaboration with Healios, and we are actively working with them with to complete the broader collaboration expansion by April 30, 2018, as we disclosed earlier today. In doing so, this would result in committed capital in the amount of $56.1 million, of which $31.1 million is already committed, in the form of the initial equity investment and license fee payments. Importantly, the broadened collaboration would lead to increased development of MultiStem treatment in Asia and provide us with capital to support our pivotal registration study for ischemic stroke, MASTERS-2, in the United States and Europe, as well as other important activities," commented Dr. Gil Van Bokkelen, CEO of Athersys.

Fourth Quarter 2017 and Recent Highlights:

Announced today plans to significantly expand our existing HEALIOS K.K. ("Healios") collaboration, including a $21.1 million equity investment and $10 million in guaranteed license fees, and, if the expansion is consummated, would also further provide an additional $25 million in committed payments over time. As part of the expansion, Healios would receive a license to MultiStem products for acute respiratory distress syndrome ("ARDS") and trauma in Japan, and Healios’ organ bud technology and certain ophthalmological indications globally. Also, Healios would receive an exclusive option to license MultiStem products for ischemic stroke, ARDS and trauma in China, and Athersys would be entitled to license fees, milestone payments and escalating royalties for the licensed indications;
Advanced our preparations for the MASTERS-2 Phase 3 registration study for ischemic stroke, to enable initiation of this important study;
Entered into a new equity facility in February 2018 as follow-on to current facility, with right to sell up to $100 million of common stock to Aspire Capital, LLC over three-year period, providing access to capital as needed to support our operations;
Recorded revenues of $1.2 million and a net loss of $13.1 million for the quarter ended December 31, 2017, noting that included in the net loss for the quarter was a $4.7 million non-recurring charge ($3.2 million of which was non-cash) related to a settlement and license agreement to resolve a long-standing intellectual property dispute; and
Ended 2017 with $29.3 million in cash and cash equivalents.

Other 2017 Highlights:

Received multiple special designations from regulators for our stroke program this year, including Regenerative Medicine Advanced Therapy designation and Fast Track designation from U.S. Food and Drug Administration, as well as a Final Scientific Advice positive opinion from European Medicines Device Agency;
Expanded manufacturing and process development collaborative relationships, including Nikon CeLL innovation Co., Ltd., and progressed key manufacturing campaigns and process development projects; and
Recorded revenues of $3.7 million and a net loss of $32.2 million, or $0.29 net loss per share, for the year ended December 31, 2017, again, factoring in the 2017 charge of $4.7 million for the intellectual property settlement and license.

"Over the course of 2017 and into 2018, we have undertaken and completed multiple initiatives that are intended to advance MultiStem therapy into registrational studies and ultimately to commercialization," stated Dr. Van Bokkelen. "We plan to launch our MASTERS-2 study in the second quarter, and continue to advance our manufacturing platform and capabilities. Importantly, through these activities and our collaboration expansion with Healios, we have further strengthened our financial position, while retaining North American and European rights for MultiStem therapy in ischemic stroke and other indications, while we continue to evaluate additional collaborative opportunities."

Fourth Quarter 2017 Financial Results

Total revenues for the fourth quarter of 2017 were $1.2 million compared to $1.0 million in the same period in the prior year, reflecting a combination of contract revenues and grant revenues.

Research and development expenses increased to $12.1 million in the 2017 fourth quarter from $7.1 million in the same period in the prior year. In 2017, approximately $4.7 million of license fees were expensed (of which $3.2 million was non-cash) related to a settlement and license agreement to resolve a long-standing intellectual property dispute. After factoring in this one-time charge, the remaining difference of $0.3 million from year-to-year was primarily due to increased clinical and preclinical development costs, which vary based on trials underway, clinical manufacturing and process development activities.

General and administrative expenses remained relatively consistent at $2.1 million and $2.0 million in the 2017 and 2016 fourth quarters, respectively.

Net loss was $13.1 million in the fourth quarter of 2017, compared to net loss of $7.1 million for the same period of 2016. The increase in net loss was primarily due to the variances outlined above (e.g., settlement and license fees) and a $1.1 million gain in the fourth quarter of 2016 related to the fair value of our warrant liabilities (non-cash), with no corresponding warrant activity in the 2017 fourth quarter, since all of our warrants were either exercised or expired early in 2017.

Full Year 2017 Financial Results

Revenues decreased to $3.7 million for the year ended December 31, 2017 from $17.3 million in 2016, related to a $15.0 million payment received and recognized as revenue for the Healios collaboration entered into in January 2016, partially offset by 2017 increases in other contract revenues, including a $1.0 million milestone payment from our collaboration with RTI Surgical, Inc. and manufacturing and service proceeds from Healios.

Research and development expenses increased to $27.8 million for the year ended December 31, 2017 from $24.8 million for the year ended December 31, 2016. After factoring in the non-recurring charge of $4.7 million for license fees referred to above, the decrease in research and development expenses year-over-year of $1.7 million related primarily to reduced spending on research supplies of $0.9 million and sponsored research of $0.5 million.

General and administrative expenses increased to $8.5 million in 2017 from $7.8 million in 2016. The $0.7 million increase was due primarily to increases in personnel costs and legal and professional services.

Net loss was $32.2 million in 2017, compared to $15.3 million in 2016. The difference of $16.9 million reflects the variances above, particularly the $15.0 million Healios revenue in 2016 and the $4.7 million one-time license fee expense in 2017, as well as an increase in 2017 of $1.3 million in the gain in the fair value of warrant liabilities, a decrease in 2017 of $0.7 million in the gain from insurance proceeds, and overall variances in operational activities.

Cash used in operating activities was $24.0 million and $10.9 million for full year 2017 and full year 2016, respectively, which takes into account the $15.0 million initial license fee revenue from Healios in 2016 and the other variances noted above.

As of December 31, 2017, we had $29.3 million in cash and cash equivalents, compared to $14.8 million at December 31, 2016.

Conference Call

Gil Van Bokkelen, Chairman and Chief Executive Officer, William (BJ) Lehmann, President and Chief Operating Officer, and Laura Campbell, Senior Vice President of Finance will host a conference call today to review the results as follows:
Date Tuesday, March 13, 2018
Time 4:30 p.m. (Eastern Time)
Telephone access: U.S. and Canada 800-273-1254
Telephone access: International 973-638-3440
Access code 8898346
Live webcast www.athersys.com, under the Investors section

A replay will be available for on-demand listening shortly after the completion of the call until 11:59 PM Eastern Time on March 27, 2018 at the aforementioned URL, or by dialing (800) 585-8367 or (855) 859-2056 in the U.S. and Canada, or from abroad (404) 537-3406, and entering access code 8898346. The archived webcast will be available for one year at the aforementioned URL.

Kura Oncology has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Kura Oncology, 2018, MAR 12, 2018, View Source [SID1234524708]).

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On March 12, 2018 Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of genes, reported financial results for the fourth quarter and year ended December 31, 2017 and provided an update on recent accomplishments and planned upcoming events (Press release, Syros Pharmaceuticals, MAR 12, 2018, View Source [SID1234524683]).

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"2017 was an important year for Syros, marked by clinical and preclinical data for SY-1425 and SY-1365 that lay a clear path forward for the further development of both programs," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "Additionally, our pioneering gene control platform continued to deliver, enabling us to expand our early-stage pipeline in cancer and monogenic diseases and enter into a collaboration with Incyte designed to allow us to benefit patients with diseases beyond our current areas of focus. We built on our strong foundation, adding to the leadership team and fortifying our cash position to fund our planned operations into 2020 and drive SY-1425 and SY-1365 to key value inflection points. As we enter 2018, we believe we are well-positioned to execute on our near-term and long-term goals to achieve our vision of becoming a fully integrated biopharmaceutical company with medicines that provide a profound and durable benefit for patients."

Upcoming Milestones

Syros plans to report clinical data in the fourth quarter of 2018 from a cohort in its ongoing Phase 2 trial evaluating SY-1425 in combination with azacitidine in RARA and IRF8 biomarker-positive newly diagnosed acute myeloid leukemia (AML) patients who are not suitable candidates for standard chemotherapy.
Syros plans to report clinical data in the fourth quarter of 2018 from a pilot cohort in its ongoing Phase 2 trial evaluating SY-1425 in combination with daratumumab in RARA and IRF8 biomarker-positive relapsed or refractory AML and higher-risk myelodysplastic syndrome (MDS) patients.
Syros plans to open expansion cohorts in mid-2018 in its ongoing Phase 1 trial of SY-1365 evaluating it as a single agent and in combination with carboplatin in multiple ovarian cancer patient populations. Based on emerging preclinical data showing anti-tumor activity of SY-1365 in hormone receptor-positive (HR-positive) breast cancer models, the Company announced today that it also plans to add an expansion cohort evaluating SY-1365 in combination with fulvestrant in HR-positive metastatic breast cancer patients who progress after treatment with a CDK4/6 inhibitor plus an aromatase inhibitor.
Syros plans to report clinical data in the fourth quarter of 2018 from the dose escalation portion of its ongoing Phase 1 trial of SY-1365 in advanced solid tumor patients.
Syros plans to select a new development candidate from its preclinical pipeline by the end of 2018.
Recent Platform and Pipeline Highlights

In January 2018, Syros announced that the U.S. Patent and Trademark Office issued two patents covering methods for stratifying patients with AML and MDS for treatment with SY-1425.
In January 2018, Syros announced a clinical supply agreement with Janssen Research and Development. Under the terms of the agreement, Janssen is supplying daratumumab for the combination dosing cohort in biomarker-positive relapsed or refractory AML and higher-risk MDS patients in Syros’ ongoing Phase 2 trial of SY-1425.
In December 2017, Syros presented initial clinical data from its ongoing Phase 2 trial of SY-1425 in biomarker-positive patients with AML and MDS at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, showing biological and clinical activity as a single agent and supporting ongoing development of SY-1425 in combination with other therapies:
Clinical activity was observed in 43% of evaluable relapsed or refractory AML and higher-risk MDS patients, including improvement in blood counts and reductions in bone marrow blasts.
Myeloid differentiation was observed, including the induction of CD38 in 85% of evaluable patients.
SY-1425 generally well-tolerated with chronic, daily dosing with the majority of adverse events being low grade.
In December 2017, Syros presented new preclinical data on SY-1365 at ASH (Free ASH Whitepaper). The data showed anti-tumor activity in leukemia and lymphoma cell lines and in vivo models of AML. Additionally, the data pointed to a potential biomarker of response to SY-1365 and demonstrated synergistic activity with venetoclax, a BCL2 inhibitor, in preclinical AML models.
In December 2017, Syros presented new preclinical data on SY-1365 at the San Antonio Breast Cancer Symposium (SABCS). The data demonstrated anti-tumor activity across a broad panel of breast cancer cell lines and pointed to potential biomarkers of response. Syros also presented on its analysis of regulatory regions of the genome in cancer stem cell-enriched triple negative breast cancer (TNBC) cell lines, which revealed key genes that may be involved in driving disease relapse and metastasis in TNBC and suggest potential new targets for future drug discovery and development.
Recent Corporate Highlights

Syros reported the appointment of Joseph J. Ferra as Chief Financial Officer.
In January 2018, Syros announced the closing of an underwritten public offering of 4,816,753 shares of common stock at a public offering price of $9.55 per share, including the exercise in full by the underwriters of their option to purchase additional shares of common stock. Syros received aggregate gross proceeds of approximately $46 million, before deducting underwriting discounts and commissions and estimated offering expenses. In connection with the offering, Incyte Corporation, exercised its right to purchase shares of Syros common stock directly from the company at the public offering price, in a concurrent private placement, resulting in proceeds of approximately $1.4 million.
In January 2018, Syros announced a global target discovery and validation collaboration with Incyte focused on myeloproliferative neoplasms (MPNs). Under the terms of the agreement, Syros will use its proprietary platform to identify novel therapeutic targets with a focus in MPNs. Incyte has options to obtain exclusive worldwide rights to intellectual property resulting from the collaboration for up to seven validated targets and, upon exercise of its options, will have exclusive worldwide rights to develop and commercialize any therapies under the collaboration that modulate those validated targets. Incyte paid Syros $10 million in upfront cash and purchased a total of $10 million in Syros common stock at a price of $12.61 per share. In addition, Syros could receive up to $54 million from Incyte in target validation and option exercise fees and up to $115 million in potential development, regulatory and commercial milestone payments per target for up to seven validated targets, plus low single-digit royalties on sales of products that result from the collaboration.
In November 2017, Syros announced the appointment of Jeremy P. Springhorn, Ph.D., as Chief Business Officer.
Fourth Quarter 2017 Financial Results

Cash, cash equivalents and marketable securities as of December 31, 2017 were $72.0 million, compared with $83.6 million on December 31, 2016. Cash, cash equivalents and short-term investments as of December 31, 2017 do not include the aggregate gross proceeds of approximately $46 million from Syros’ underwritten public offering of common stock, which closed in February 2018, the $1.4 million in proceeds from the private placement of stock with Incyte concurrent with the public offering, or the $10 million upfront payment and purchase of $10 million in Syros common stock received in January 2018 in connection with entry into the collaboration with Incyte.

For the fourth quarter of 2017, Syros reported a net loss of $15.3 million, or $0.58 per share, compared to a net loss of $11.0 million, or $0.47 per share, for the same period in 2016. Stock-based compensation included in the net loss was $1.3 million for the fourth quarter of 2017, compared to $0.7 million for the same period in 2016.

Research and development (R&D) expenses were $11.8 million for the fourth quarter of 2017, as compared to $8.4 million for the same period in 2016. Stock-based compensation included in R&D expenses was $0.5 million for the fourth quarter of 2017, compared to $0.2 million for the same period in 2016.
General and administrative (G&A) expenses were $3.7 million for the fourth quarter of 2017, as compared to $2.9 million for the same period in 2016. Stock-based compensation included in G&A expenses was $0.8 million for the fourth quarter of 2017, compared to $0.5 million for the same period in 2016.
Full Year 2017 Financial Results

For the full year ended December 31, 2017, net loss was $54.0 million, or $2.13 per share, as compared to a net loss of $47.7 million, or $4.05 per share, for the same period in 2016. Stock based compensation included in the net loss was $4.4 million for the year ended December 31, 2017, compared to $4.2 million for the same period in 2016.

R&D expenses were $41.9 million for the year ended December 31, 2017, as compared to $37.8 million for the same period in 2016. The increase was due to an increase in expenses from third parties that conduct research and development and preclinical activities on our behalf, including an increase in clinical development costs for SY-1425 and SY-1365, offset by a decrease in preclinical development work for SY-1365 as toxicology studies were completed and the Phase 1 clinical trial was initiated. Stock-based compensation included in R&D expenses was $1.7 million for the year ended December 31, 2017, compared to $3.0 million for the same period in 2016.
G&A expenses were $13.9 million for the year ended December 31, 2017, as compared to $10.5 million for the same period in 2016. The increase was largely due to an increase in employee-related costs, including salary, benefits and stock-based compensation, as well as increased consulting, licensing, and professional fees to support the overall growth of the Company. Stock-based compensation included in G&A expenses was $2.7 million for the year ended December 31, 2017, compared to $1.2 million for the same period in 2016.
Financial Guidance

Based on its current plans, Syros believes that its cash, cash equivalents and short-term investments as of December 31, 2017, together with cash received in connection with entry into the collaboration with Incyte and the underwritten public offering and concurrent private placement of common stock that closed in February 2018, will be sufficient to enable it to fund its planned operating expense and capital expenditure requirements into 2020.