On March 1, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) today reported consolidated financial results for the fourth quarter and year ended 2017, as well as progress in its clinical development programs (Press release, NewLink Genetics, MAR 1, 2018, View Source [SID1234524320]). The Company also outlined key 2018 business priorities related to the clinical programs for indoximod, its IDO pathway inhibitor drug candidate.

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"NewLink Genetics has produced encouraging data supporting indoximod in several indications and looks forward to presenting additional data in 2018, further validating IDO pathway inhibition as a key target in immuno-oncology," said Charles J. Link, Jr, MD, Chairman and Chief Executive Officer. "In addition, Indigo301, our pivotal trial for patients with metastatic melanoma, and Indigo201, our randomized Phase 2 trial in collaboration with AstraZeneca for patients with metastatic pancreatic cancer, are our core clinical priorities for 2018."
Anticipated 2018 Highlights
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Initiate randomization portion of Indigo301, a pivotal Phase 3 trial for patients with advanced melanoma, in Q2-Q3 2018
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Full Phase 2 results of indoximod plus checkpoint inhibitors in metastatic melanoma in 1H:2018
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Initiate Indigo201, a randomized Phase 2 trial for patients with metastatic pancreatic cancer, in 1H:2018
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Full Phase 2 results from the single-arm trial of indoximod plus gemcitabine nab-paclitaxel in metastatic pancreatic cancer in 1H:2018
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Two abstract presentations at AACR (Free AACR Whitepaper) Annual Meeting 2018 include data from a Phase 1 study of indoximod for pediatric patients with malignant brain tumors and data providing additional characterization of the differentiated mechanism of action of indoximod
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Continued evaluation of indoximod in additional oncology indications
2017 Highlights
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Presented updated Phase 2 data of indoximod plus pembrolizumab in advanced melanoma at the Third Annual International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) with encouraging overall and complete response rates and progression-free survival
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Commenced dose determination portion of Indigo301
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Entered into a collaboration with AstraZeneca on Indigo201
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Presented Phase 2 data from a randomized, double-blind study of indoximod plus cancer vaccine for patients with metastatic castration-resistant prostate cancer at ASCO (Free ASCO Whitepaper) Annual Meeting, indicating statistically significant improvement in median progression-free survival compared to monotherapy

Exhibit 99.1

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Presented Phase 1b data of indoximod plus chemotherapy in newly diagnosed AML suggesting the potential for indoximod in treatment regimens beyond PD-1
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Successfully raised $74.3 million, net of offering costs, and ended 2017 with $158.7 million cash and equivalents
Update on Current Clinical Timeline and Financial Guidance
NewLink Genetics reported an update of its clinical timeline and now expects to initiate Indigo301 randomization in Q2 to Q3 2018 and complete enrollment in 2019. The Company expects to end this year with approximately $75 million in cash. The shift in the timeline arises from an increased number of trial sites planned for Indigo301 and additional work related to manufacturing.
Financial Results
Cash Position: NewLink Genetics ended the year on December 31, 2017, with cash and cash equivalents totaling $158.7 million compared to $131.5 million for the year ending December 31, 2016. The Company’s cash position is sufficient to fund operations in the near and medium term.
R&D Expenses: Research and development expenses were $17.5 million and $69.9 million in the fourth quarter and year ended December 31, 2017 compared to $19.5 million and $93.3 million during the comparable periods in 2016. The decrease year-over-year was due primarily to higher restructuring charges of $11.1 million incurred in 2016, including a non-cash charge of $4.0 million related to impaired assets, as compared to $600,000 of charges incurred in 2017. Remainder of the decrease was due to decreases of $6.2 million in clinical trial costs, $4.4 million in supplies, equipment and licensing, $3.6 million in personnel-related expense, and $200,000 in manufacturing expense. Decreases were offset by increases of $1.0 million in stock compensation expense and $600,000 in legal and consulting.
G&A Expenses: General and administrative expenses in the fourth quarter and year ended December 31, 2017 were $6.7 million and $31.7 million compared to $7.2 million and $33.2 million during the comparable periods in 2016. The decrease was primarily due to a $2.3 million reduction in personnel-related spend and $1.2 million reduction in legal and consulting, offset by increases of $700,000 in stock compensation expense, $700,000 in supplies and equipment, and $600,000 in restructuring charges incurred in 2017.
Net Loss: NewLink Genetics reported a net loss of $13.7 million or $0.37 per diluted share for the fourth quarter of 2017 and a net loss of $72.0 million or $2.30 per diluted share for the year ended December 31, 2017, compared to a net loss of $13.5 million or $0.46 per diluted share for the fourth quarter of 2016 and a net loss of $85.2 million or $2.94 per diluted share for the year ended December 31, 2016.
NewLink Genetics ended 2017 with 37,109,556 shares outstanding.
Conference Call and Webcast Details
The Company has scheduled a conference call and webcast for 4:30 p.m. ET today to discuss the results and to give an update on clinical and business development activities. NewLink Genetics’ senior management team will host the call, which will be open to all listeners. There will also be a question and answer session following the prepared remarks.
Access to the live conference call is available by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international) five minutes prior to the start of the call. The conference call will be webcast live and a link to the webcast can be accessed through the NewLink Genetics website at www.NewLinkGenetics.com in the "Investors & Media" section under "Events and Presentations" or by clicking here. To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 9466627. The replay will be available for two weeks from the date of the call.

About Indoximod
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including anti-PD-1/PD-L1 agents, cancer vaccines, and chemotherapy across multiple indications such as melanoma, pancreatic cancer and other malignancies.

On March 1, 2018 PDL BioPharma, Inc. (PDL or the Company) (NASDAQ: PDLI) reported that the Company will release its fourth quarter, year-end 2017 financial results for the period ended December 31, 2017, on Thursday March 8, 2018, after market close. PDL’s management will host a conference call and webcast that day at 4:30 p.m (Press release, PDL BioPharma, MAR 1, 2018, View Source [SID1234524315]). Eastern Time to discuss the financial results. A slide presentation relating to the call will be available via the webcast link on the PDL website.

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Conference Call Details
To access the live conference call via phone, please dial (800) 668-4132 from the United States and Canada or (224) 357-2196 internationally. The conference ID is 9384627. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 9384627.

To access the live and subsequently archived webcast of the conference call, go to the Company’s website at View Source and go to "Events & Presentations." Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

On March 1, 2018 Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, reported financial results and provided an update on financial, clinical, and regulatory filing activities for the quarter and full year ended December 31, 2017 (Press release, Paratek Pharmaceuticals, MAR 1, 2018, View Source [SID1234524314]).

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"We had a strong finish to the year as we initiated our Phase 2 program in urinary tract infections and, importantly, we recently announced the completion of the rolling NDA submissions for omadacycline," said Michael Bigham, Chairman and Chief Executive Officer, Paratek. "We continue to expand our commercial readiness activities for omadacycline as we await the FDA’s acceptance of our NDAs".

Recent Highlights

Completed submission of New Drug Applications (NDAs) with the U.S. Food and Drug Administration (FDA) on February 2, 2018 for the once-daily oral and intravenous formulations of omadacycline for the treatment of community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI)

Advanced commercial readiness activities, including initiation of manufacturing validation and commercial product supply and expansion of the medical affairs and payer account management teams in readiness for payer formulary discussions

Initiated the first of two Phase 2 studies of omadacycline in urinary tract infections (UTI)

Announced FDA acceptance of Allergan’s NDA for Seysara

Raised $50.0 million through a registered underwritten public offering of common stock

Upcoming Milestones

FDA acceptance of omadacycline NDAs anticipated in April 2018

Formulary discussions with payers to begin post FDA acceptance of NDA filing

Presentation of clinical and microbiological data at the upcoming European Congress of Clinical Microbiology and Infectious Disease, including nine posters and one oral presentation of the OASIS-2 study of oral-only omadacycline in ABSSSI

European pre-submission meetings planned for the second quarter of 2018

Fourth Quarter and Full Year 2017 Financial Results

For the fourth quarter of 2017, Paratek reported a net loss of $21.9 million, or ($0.78) per share, compared to a net loss of $26.5 million, or ($1.16) per share, for the same period in 2016. For the year ended December 31, 2017, Paratek reported a net loss of $89.1 million, or ($3.32) per share, compared to a net loss of $111.6 million, or ($5.51) per share, for the same period in 2016.

Revenue earned during the year ended December 31, 2017 primarily consists of a $7.5 million upfront payment

received as part of a collaboration agreement with Zai Lab and a $5.0 million milestone payment earned from Allergan on FDA acceptance of the Seysara NDA.

Research and development expenses were $14.2 million and $60.1 million for the quarter and year ended December 31, 2017, respectively, compared to $19.7 million and $83.5 million for the same periods in 2016. The decrease was driven primarily by lower clinical study costs associated with the completion of the Phase 3 program for omadacycline. This decrease is partially offset by higher employee compensation costs, NDA preparation and related user fees, and an increase in medical affairs activity.

General and administrative expenses were $11.7 million and $37.0 million for the quarter and year ended December 31, 2017, respectively, compared to $6.5 million and $26.4 million for the same periods in 2016. The increase was driven primarily by higher employee compensation costs as the Company continues to expand its commercial team, costs associated with pre-commercial activities, and business development efforts.

As of December 31, 2017, Paratek had cash, cash equivalents, and marketable securities of $151.7 million. Based on current assumptions, including full commercial buildout and launch of omadacycline, Paratek’s existing capital resources as well as the $50 million in proceeds from its January 2018 public offering of common stock, future contingent regulatory and commercial milestone payments from collaborations with Allergan and Zai Lab, anticipated extension of the interest-only period for the Hercules Term Loan, and estimated omadacycline product sales will enable Paratek to fund operating expenses and capital expenditure requirements into late 2019.

Conference Call and Webcast

Paratek’s earnings conference call for the quarter ended December 31, 2017 will be broadcast at 8:30 a.m. EDT on March 1, 2018. The live webcast can be accessed under "Events and Presentations" in the Investor Relations section of Paratek’s website at www.paratekpharma.com.

Domestic investors wishing to participate in the call should dial: 877-407-0792 and international investors should dial: 201-689-8263. The conference ID is 13675875. Investors can also access the call at View Source

Replays of the call will be available through March 15, 2018. Domestic investors can access the replay by dialing 844-512-2921 and international investors can access the replay by dialing 412-317-6671. The PIN code to access the replay is 13675875.

Website Information

Paratek routinely posts important information for investors on the Investor Relations section of its website at www.paratekpharma.com. Paratek intends to use this website as a means of disclosing material, non-public information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investor Relations section of Paratek’s website, in addition to following its press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Paratek’s website is not incorporated by reference into, and is not a part of, this document.

On March 1, 2018 OPKO Health, Inc. (NASDAQ: OPK) reports business highlights and financial results for the three months ended December 31, 2017 (Press release, Opko Health, MAR 1, 2018, View Source [SID1234524313]).

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Business Highlights

RAYALDEE total prescriptions reported by IMS increased 47% in Q4 2017 compared with Q3 2017: Total prescriptions were more than 3,900 during the three months ended December 31, 2017. As of January 1, 2018, more than 79% of patients have access to RAYALDEE under their insurance plans.

4Kscore utilization increased 15% in Q4 2017 compared with Q4 2016: OPKO has undertaken a number of initiatives to drive utilization of the 4Kscore test, the Company’s blood test that gives a man with elevated prostate specific androgen (PSA) levels a personalized prediction of his chance of having or developing an aggressive form of prostate cancer. OPKO launched regional television ads in the Northeast for the 4Kscore test on November 21, 2017 and expanded the television ads to Florida in February 2018.

Premarket Approval (PMA) application for Claros point-of-care (POC) PSA test submitted to FDA: On November 6, 2017, OPKO submitted a PMA for a PSA test utilizing the Claros 1 immunoassay analyzer, a novel diagnostic instrument that can provide rapid, quantitative blood test results in 10 minutes in the physician’s office with only a finger stick drop of whole blood. A second product on the same platform for testosterone is advancing toward a 510(k) submission to the FDA later this year.

Global and Japan Phase 3 and registration studies for hGH-CTP in pediatric growth hormone deficient children are making good progress in enrolling patients: The global pediatric study is a pivotal, non-inferiority design comparing a single weekly administration of hGH-CTP with daily injections of a currently marketed growth hormone product. This study is expected to complete enrollment this year. The global and Japanese pediatric studies utilize the pen device and formulation that will be launched commercially upon approval. The pediatric segment represents more than 80% of the commercial market for treatment of hGH deficiency.

Initiated a Phase 2b clinical trial for OPK88004, an orally administered selective androgen receptor modulator (SARM): In November 2017, OPKO initiated a Phase 2b dose-ranging study for the treatment of men with benign prostatic hypertrophy (BPH), or enlarged prostate. OPK88004 is expected to improve the symptoms of BPH by reducing prostate size and, on the basis of data from a previous trial in 350 men, increase muscle mass and bone strength and decrease fat mass. BPH affects approximately 50 million men in the U.S.

Initiation of four Phase 2 clinical trials anticipated in 2018:

• RAYALDEE line extension in dialysis patients with secondary hyperparathyroidism (SHPT): Together with its partners Vifor Fresenius and Japan Tobacco, OPKO is developing RAYALDEE for Stage 5 chronic kidney disease (CKD) patients with SHPT undergoing dialysis and anticipates initiating a global Phase 2 trial in dialysis centers in the second quarter of this year.
• OPK88003, a once-weekly oxyntomodulin dual GLP1-Glucagon agonist for type 2 diabetes and obesity: OPKO expects to initiate a Phase 2b dose-escalation study with OPK88003 in the second quarter of this year. In a 420-patient Phase 2 trial in patients with type 2 diabetes, OPK88003 reduced HbA1c levels similar to exenatide extended-release (Ex ER). The drug also showed statistically significantly greater weight loss and lowering of total cholesterol and triglycerides compared to once-weekly Ex ER, with a good safety profile.
• OPK88002, an NK-1 antagonist to treat pruritus (itching) in Stage 5 CKD patients undergoing dialysis: An Investigational New Drug application was submitted to the FDA and plans are being finalized to begin a single-dose Phase 2a trial of OPK88002 in dialysis patients to treat severe itching. Approximately 50% of renal dialysis patients experience difficult to control pruritus.
• OPK88001 for the treatment of Dravet Syndrome: Three clinical research centers in the United States are expected to participate in this first in human clinical study of the AntagoNAT for treatment of Dravet Syndrome.
Financial Highlights

Net loss of $213.9 during the three months ended December 31, 2017 included $147.7 million of non-recurring or non-cash items consisting of:

o
o
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$73.3 million of revenue adjustments
$13.2 million of intangible impairment related to VARUBI
$61.2 million Income tax provision
Consolidated revenues for the three months ended December 31, 2017 were $193.7 million compared to $275.5 million for the comparable period of 2016. During the three months ended December 31, 2017, revenue from services were negatively impacted by non-recurring reimbursement adjustments from commercial and federal payor programs of $73.3 million and by reduced sample volume of $9.3 million.Revenue from products included $9.1 million of revenue from RAYALDEE, including $6.2 million related to revenue previously deferred through September 30, 2017.
During the three months ended December 31, 2017, operating expenses included investment in the commercial activities supporting the launch of RAYALDEE of $7.9 million, as well as continued investment in the Company’s pharmaceutical pipeline, with R&D expense increasing to $34.2 million. In addition, fourth quarter 2017 operating expenses included a $13.2 million impairment related to our VARUBI intangible assets as a result of our licensee’s discontinuation of the IV formulation.
During the three months ended December 31, 2017, a $61.2 million income tax provision was recorded, principally as a result of the Tax Cuts and Jobs Act ($31.8 million) as well as recording a valuation allowance against our U.S. based deferred tax assets. The comparable period of 2016 includes an income tax benefit of $31.5 million.
Cash, cash equivalents and marketable securities were $91.5 million as of December 31, 2017.
OPKO strengthened its balance sheet with a $55 million private placement of convertible notes issued on February 27, 2018.

CONFERENCE CALL & WEBCAST INFORMATION

OPKO’s senior management will provide a business update and discuss results in greater detail in a conference call and live audio webcast at 4:30 p.m. Eastern time today. The conference call dial-in and webcast information is as follows:

DOMESTIC DIAL-IN:
866-634-2258
INTERNATIONAL DIAL-IN:
330-863-3454
PASSCODE:
1973978
WEBCAST:
View Source
For those unable to participate in the live conference call or webcast, a replay will be available beginning March 1, 2018 approximately two hours after the close of the conference call. To access the replay, dial 855-859-2056 or 404-537-3406. The replay passcode is 1973978. The replay can be accessed for a period of time on OPKO’s website at View Source.

On March 1, 2018 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 release its year end 2017 financial results on March 8, 2018 before the market opens (Press release, Onconova, MAR 1, 2018, View Source [SID1234524312]).

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The Company will host a conference call to discuss these results and provide an update on all rigosertib programs, including promising interim analysis for the INSPIRE trial, on March 8, 2018 at 9:00 a.m. Eastern Time.

Interested parties may access the call by dialing toll-free (855) 428-5741 from the US, or (210) 229-8823 internationally and using conference ID 2947108.

The call will also be webcast live. Please click here to access the webcast.

A replay will be available at that link until June 29, 2018.