On July 31, 2018 Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) reported financial results and provided a business update for the second quarter of 2018 (Press release, Progenics Pharmaceuticals, JUL 31, 2018, View Source [SID1234528438]).

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"We’re extremely proud of our recent accomplishments, most notably the FDA approval of AZEDRA, which is a critical breakthrough for patients suffering from pheochromocytoma or paraganglioma, and completes our transition to a commercial organization focused on oncology," commented Mark Baker, Chief Executive Officer of Progenics. "As we commence the commercial launch of AZEDRA, we continue to advance our portfolio of PSMA-targeted radiopharmaceuticals and artificial intelligence imaging analysis technologies. We expect top-line results from the Phase 3 trial evaluating 1404, our PSMA-targeted SPECT/CT imaging agent, and the Phase 2/3 trial for PyL, our PSMA-targeted PET/CT imaging agent, in the third and fourth quarter of this year, respectively."

Second Quarter and Recent Key Business Highlights

AZEDRA (iobenguane I 131) 555 MBq/mL injection for intravenous use, Ultra-orphan Radiotherapeutic

FDA Approval of AZEDRA for the Treatment of Unresectable, Locally Advanced or Metastatic Pheochromocytoma or Paraganglioma

In July 2018, Progenics announced the FDA approval of its New Drug Application (NDA) for AZEDRA. The FDA approval of AZEDRA marks the first and only approved therapy in the U.S. for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy.

Data from Pivotal Phase 2 AZEDRA Study Presented at ASCO (Free ASCO Whitepaper)
In June 2018, during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, Progenics presented updated overall survival and safety data from its pivotal Phase 2 study of AZEDRA. Data presented showed the median overall survival time as of December 4, 2017 was 44 months among patients who received two therapeutic doses, compared to 18 months among patients who received only one therapeutic dose. Long-term patient follow-up continues.

Progenics Announces Second Quarter 2018 Financial Results

PSMA-Targeted Prostate Cancer Pipeline

Data from Phase 3 Study of 1404 Expected in Third Quarter

In January 2018, Progenics announced the completion of enrollment of its Phase 3 study of 1404, a PSMA-targeted small molecule SPECT/CT imaging agent. The ProSPECT-AS study dosed 471 patients with newly-diagnosed or low-grade prostate cancer, whose biopsy indicates a histopathologic Gleason grade of ≤ 3+4 severity and/or are candidates for active surveillance. The Company expects to announce top-line data in the third quarter of 2018.

Enrollment Completed in Phase 2/3 Study of PyL, with Data Expected in Fourth Quarter

In June 2018, Progenics announced the completion of enrollment in its Phase 2/3 OSPREY study evaluating the diagnostic accuracy of its PSMA-targeted PET/CT imaging agent, PyL (18F-DCFPyL), in prostate cancer. The OSPREY study enrolled 266 patients with localized high risk prostate cancer and 117 patients with recurrent or metastatic prostate cancer in the U.S. and Canada for a total of 383 patients. The Company expects to announce top-line data in the fourth quarter of 2018.

Phase 1 Study of 1095

1095, a small molecule radiotherapeutic that selectively binds to PSMA, is in a Phase 1 open-label dose escalation study in patients with metastatic castration-resistant prostate cancer (mCRPC) who have demonstrated tumor avidity to 1095.

Initiation of Phase 1 Study for PSMA-TTC by Bayer Expected in 2018

Progenics expects its partner Bayer to initiate a Phase 1 study of PSMA-Targeted Thorium Conjugate (PSMA-TTC) in patients with mCRPC by year end 2018. Bayer was previously granted exclusive worldwide rights to develop and commercialize products using Progenics’ PSMA antibody technology in combination with Bayer’s alpha-emitting radionuclides.

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Data Validating Artificial Intelligence Imaging Analysis Presented at SNMMI

At the 2018 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in June 2018, Progenics presented data demonstrating the utility of its imaging analysis technology, which uses artificial intelligence and machine learning to quantify and automate the reading of PSMA targeted imaging. Data from the Company’s Phase 2 study of 1404 was used to develop a deep learning algorithm for the purpose of the automatic detection and quantification of 1404 uptake from SPECT/CT images as compared to a manual process.

Imaging Analysis Platform Highlighted in JAMA Oncology

In May 2018, Progenics announced the publication of results from a trial evaluating the use of its automated bone scan index (aBSI) in men with mCRPC in JAMA Oncology. aBSI automatically calculates the Bone Scan Index utilizing artificial intelligence to help quantify prostate cancer disease burden. The study demonstrated that aBSI was associated with overall survival and prostate cancer-specific survival (p<0.001), time to symptomatic progression (p<0.001), and time to opiate use for cancer pain (p<0.001).

Progenics Announces Second Quarter 2018 Financial Results

RELISTOR, Treatment for Opioid-Induced Constipation (partnered with Bausch Health Companies Inc.)

Second Quarter 2018 RELISTOR Net Sales of $23.5 Million

The second quarter 2018 net sales of RELISTOR, as reported to Progenics by its partner Bausch Health Companies, Inc. (formerly known as Valeant Pharmaceuticals, Inc.), translated to $3.5 million in royalty revenue for Progenics for the quarter. Total second quarter 2018 RELISTOR U.S. net sales increased 44% over the second quarter of 2017.

Second Quarter 2018 Financial Results

Second quarter revenue totaled $3.9 million, up from $2.8 million in the second quarter of 2017, reflecting RELISTOR royalty income of $3.5 million compared to $2.6 million in the corresponding period of 2017.

Second quarter research and development expenses decreased by $1.9 million compared to the corresponding prior year period, resulting primarily from lower clinical trial expenses for AZEDRA and 1404. Second quarter general and administrative expenses increased by $1.2 million compared to the corresponding prior year period, primarily attributable to higher costs associated with building commercial capabilities in preparation for the planned launch of AZEDRA. Progenics also recorded non-cash adjustments of $1.3 million in the second quarter 2018, related to changes in the fair value estimate of the contingent consideration liability. For the three months ended June 30, 2018, Progenics recognized interest expense of $1.2 million related to the RELISTOR royalty-backed loan.

Net loss for the second quarter was $15.2 million, or $0.20 per diluted share, compared to net loss of $16.6 million, or $0.24 per diluted share, in the corresponding 2017 period.

Progenics ended the second quarter with cash and cash equivalents of $87.5 million, a decrease of $3.1 million compared to cash and cash equivalents as of December 31, 2017. In order to continue to maintain a strong financial position, the Company raised $19.4 million in net proceeds from sales of its common stock under its "at-the-market" (ATM) facility in April through July 20, 2018, with $4.8 million received in July.

Financial Tables follow –

Progenics Announces Second Quarter 2018 Financial Results

PROGENICS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

Progenics Announces Second Quarter 2018 Financial Results

Approved Use:

AZEDRA (iobenguane I 131) is a prescription medicine used to treat adult and pediatric patients 12 years and older with cancers known as pheochromocytoma and paraganglioma that are positive for the norepinephrine transporter (as determined by an iobenguane scan), and who require systemic anticancer therapy.

Important Safety Information

AZEDRA can cause serious side effects. If you experience these side effects, your health care provider may need to adjust or stop your treatment. You should always follow your health care provider’s instructions. Serious side effects may include:

Radiation exposure: Treatment with AZEDRA will expose you to radiation which can contribute to your overall long-term radiation exposure. Overall radiation exposure is associated with an increased risk for cancer. Radiation risk is greater in children than in adults. You should stay well hydrated before, during, and after your treatment and urinate frequently. Your doctor will advise you on how to lessen exposure to people who may come into contact with you after AZEDRA treatment.

Bone marrow problems and other cancers: Treatment with AZEDRA may cause your blood cell counts to drop (myelosuppression). You may experience blood-related side effects such as low numbers of cells that are responsible for blood clotting (thrombocytopenia), low numbers of a type of white blood cells (neutropenia), and low red blood cells (anemia). Among the 88 patients who received a therapeutic dose of AZEDRA, 33% experienced Grade 4 thrombocytopenia, 16% experienced Grade 4 neutropenia, and 7% experienced Grade 4 anemia. Five percent of patients experienced febrile neutropenia (neutropenia with fever). People with low blood counts can develop serious infections. Your health care provider will routinely check your blood counts and tell you if they are too low. Tell your doctor if you experience any symptoms of low blood counts or infection, such as fever, chills, dizziness, shortness of breath, or increased bleeding or bruising. Your health care provider may need to adjust or stop your treatment accordingly. Other conditions that you may develop as a direct result of treatment with AZEDRA are blood and bone marrow cancers known as secondary myelodysplastic syndrome (MDS) and leukemia. MDS or acute leukemias were reported in 6.8% of the 88 patients who received a therapeutic dose of AZEDRA. The time to development of MDS or acute leukemia ranged from 12 months to 7 years. Two of the 88 patients developed other types of cancer.

Thyroid problems: Treatment with AZEDRA may increase your long-term risk of developing an underactive thyroid (hypothyroidism) or thyroid cancer. Hypothyroidism was reported in 3.4% of the 88 patients who received a therapeutic dose of AZEDRA. Take all thyroid-blocking agents as prescribed by your doctor to reduce the risk of these problems. You may need life-long monitoring for signs and symptoms of hypothyroidism.

Elevations in blood pressure: During or 24 hours following AZEDRA treatment, you may experience increases of blood pressure (hypertension) as a result of hormones released from your cancer. Eleven percent of the 88 patients who received a therapeutic dose of AZEDRA experienced a worsening of pre-existing hypertension. All changes in blood pressure occurred within the first 24 hours after treatment. No life-threatening hypertensive crises have been observed. Monitor blood pressure frequently during the first 24 hours after each therapeutic dose of AZEDRA. Tell your doctor if you experience any cardiac-related symptoms.

Kidney problems: Treatment with AZEDRA will expose your kidneys to radiation and may impair their ability to work as normal. In some cases, patients have experienced kidney failure after treatment with AZEDRA. Of the 88 patients who received a therapeutic dose of AZEDRA, 9% developed kidney failure or acute kidney injury, and 22% experienced a decrease in kidney function measured at 6 or 12 months. Your health care provider will monitor your kidneys after treatment using blood tests, particularly if you already have kidney impairment before treatment.

Progenics Announces Second Quarter 2018 Financial Results Page 6

Respiratory problems: Treatment with AZEDRA may cause noninfectious lung inflammation (pneumonitis). Tell your doctor if you experience shortness of breath, difficulty breathing, or cough.

Pregnancy warning: Before treatment with AZEDRA, tell your doctor if you are pregnant or plan to become pregnant. Exposure to radiation from treatment with AZEDRA can harm your unborn baby. Use an effective method of birth control during treatment with AZEDRA and for 7 months (for females) and 4 months (for males) after your final dose. Do not breastfeed during treatment with AZEDRA and for 80 days after your final dose.

Fertility problems: Treatment with AZEDRA may cause infertility due to radiation absorbed by your testes or ovaries over the treatment period that is within the range of exposure where temporary or permanent infertility may be expected.

The most common and most serious side effects of AZEDRA include decreased blood cell counts, nausea, vomiting and fatigue. These are not all the possible side effects of AZEDRA. For more information, ask your health care provider.

Drugs that reduce catecholamine uptake or that deplete catecholamine stores may interact with AZEDRA and may affect how well it works. These drugs were not permitted in the clinical trials. Tell your doctor before starting any medication, including over the counter medications, herbal or dietary supplements.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information for AZEDRA.

Distributed by: Progenics Pharmaceuticals, Inc., NY 10007

Reference:

AZEDRA prescribing information. New York, NY: Progenics Pharmaceuticals, Inc.; 07 2018.

About RELISTOR

Progenics has exclusively licensed development and commercialization rights for its first commercial product, RELISTOR, to Bausch Health Companies, Inc. RELISTOR Tablets (450 mg once daily) are approved in the United States for the treatment of opioid-induced constipation (OIC) in patients with chronic non-cancer pain. RELISTOR Subcutaneous Injection (12 mg and 8 mg) is a treatment for OIC approved in the United States and worldwide for patients with advanced illness and chronic non-cancer pain.

IMPORTANT SAFETY INFORMATION – RELISTOR (methylnaltrexone bromide) tablets, for oral use and RELISTOR (methylnaltrexone bromide) injection, for subcutaneous use

RELISTOR tablets and injection are contraindicated in patients with known or suspected gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.

Cases of gastrointestinal perforation have been reported in adult patients with opioid-induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie’s syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Take into account the overall risk-benefit profile when using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn’s disease). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom.

Progenics Announces Second Quarter 2018 Financial Results

If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their healthcare provider.

Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR. Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia and should be monitored for adequacy of analgesia and symptoms of opioid withdrawal.

Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.

The use of RELISTOR during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood brain barrier and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for serious adverse reactions, including opioid withdrawal, in breastfed infants, advise women that breastfeeding is not recommended during treatment with RELISTOR. In nursing mothers, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

A dosage reduction of RELISTOR tablets and RELISTOR injection is recommended in patients with moderate and severe renal impairment (creatinine clearance less than 60 mL/minute as estimated by Cockcroft-Gault). No dosage adjustment of RELISTOR tablets or RELISTOR injection is needed in patients with mild renal impairment.

A dosage reduction of RELISTOR tablets is recommended in patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment. No dosage adjustment of RELISTOR tablets is needed in patients with mild hepatic impairment (Child-Pugh Class A). No dosage adjustment of RELISTOR injection is needed for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, monitor for methylnaltrexone-related adverse reactions.

In the clinical studies, the most common adverse reactions were:

OIC in adult patients with chronic non-cancer pain

RELISTOR tablets (≥ 2% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (14%), diarrhea (5%), headache (4%), abdominal distention (4%), vomiting (3%), hyperhidrosis (3%), anxiety (2%), muscle spasms (2%), rhinorrhea (2%), and chills (2%).

RELISTOR injection (≥ 1% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (21%), nausea (9%), diarrhea (6%), hyperhidrosis (6%), hot flush (3%), tremor (1%), and chills (1%).

OIC in adult patients with advanced illness

RELISTOR injection (≥ 5% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (29%) flatulence (13%), nausea (12%), dizziness (7%), and diarrhea (6%).

Please see complete Prescribing Information for RELISTOR at www.bauschhealth.com. For more information about RELISTOR, please visit www.RELISTOR.com.

On July 31, 2018 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that Health Canada has accepted for review the Company’s New Drug Submission (NDS) for the medicinal product NERLYNX (neratinib) for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy (Press release, Puma Biotechnology, JUL 31, 2018, View Source [SID1234528422]). The NDS recently passed the mandatory validation period by Health Canada, the country’s federal regulator for drugs and health products, and has now entered the review period.

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"Health Canada’s acceptance of our NDS represents another important regulatory milestone in our commitment to increasing access to NERLYNX around the world to reduce disease recurrence following trastuzumab therapy in patients with early stage HER2-positive breast cancer," said Alan H. Auerbach, Chief Executive Officer and President of Puma. "We look forward to working with Health Canada during their review of our submission."

Neratinib, an oral irreversible pan-HER kinase inhibitor, was approved by the FDA in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and is marketed in the United States as NERLYNX. The drug also received a recommendation for marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) in June 2018 and is being reviewed by the European Commission, which has the authority to approve medicines for the European Union.

About HER2-Positive Breast Cancer

Approximately 20% to 25% of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

On July 31, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) reported its consolidated financial results for the second quarter of 2018, and revised its cash guidance (Press release, NewLink Genetics, JUL 31, 2018, View Source [SID1234528421]).
Update on Clinical Programs

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In early April, the Company announced a review of its clinical programs involving its lead immuno-oncology candidate, indoximod. This extensive review included an evaluation of available data from clinical trials sponsored by other companies, potential combination therapies with indoximod, and unmet medical need. Based on these key criteria, NewLink Genetics has focused its indoximod clinical programs on recurrent pediatric brain tumors, front-line treatment of diffuse intrinsic pontine glioma (DIPG), and front-line treatment of acute myeloid leukemia (AML). In addition, the company will continue to advance NLG802, the prodrug of indoximod with significantly higher pharmacokinetic exposure seen in preclinical research.

"Indoximod’s unique mechanism of action has shown promising activity against multiple cancers and in combination with checkpoint inhibitors, radiation, chemotherapy, and vaccines," said Dr. Charles J. Link, Jr., MD, Chairman and Chief Executive Officer. "We intend to focus on near-term opportunities where additional data can validate the importance of indoximod in areas of high unmet need."
Recent Key Presentations

Presented abstract 10973 entitled, Front-line therapy of DIPG using the IDO pathway inhibitor indoximod in combination with radiation and chemotherapy, during a plenary session at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting in April, reporting on six newly diagnosed DIPG patients all of whom had completed induction radio-immunotherapy. Treatment was well tolerated with symptomatic improvement in all 6 patients. Site-reported radiographic review indicated near resolution of tumor in one patient at the end of radiotherapy and observable improvement in 5 out of 6 patients overall. A seventh patient with progressive DIPG received reirradiation combined with indoximod, which was well tolerated with symptomatic improvement and objective tumor reduction per site-reported assessment on post-treatment MRI.

Presented abstract 3753 entitled, Indoximod modulates AhR-driven transcription of genes that control immune function, at the 2018 AACR (Free AACR Whitepaper) Annual Meeting in April. Reported data show indoximod reverses the effects of low tryptophan by increasing proliferation of effector T cells, directly reprograms T regulatory cells into helper T cells and also downregulates IDO expression in dendritic cells, further supporting indoximod’s differentiated mechanism of action.

Presented abstract 9512 entitled, Phase 2 trial of the IDO pathway inhibitor indoximod plus checkpoint inhibition for the treatment of patients with advanced melanoma, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting in June, demonstrating an Overall Response Rate (ORR) of 55.7% and a Complete Response (CR) of 18.6% which compares favorably to historical PD-1 monotherapy data.

Presented abstract 4015 entitled, Phase 2 trial of the IDO pathway inhibitor indoximod plus gemcitabine / nab-paclitaxel for the treatment of patients with metastatic pancreas cancer, at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting

Exhibit 99.1

in June, demonstrating a median Overall Survival (mOS) of 10.9 months and an Overall Response Rate (ORR) of 46.1%. The combination demonstrated potentially promising activity that correlated with a measurable immune response.

Presented a poster entitled, Radio-immunotherapy using the IDO pathway inhibitor indoximod for children with newly-diagnosed DIPG at the International Symposium of Pediatric Neuro-Oncology (ISPNO) 2018 Annual Meeting in July. The updated Phase 1 data showed that all (10/10) front-line treatment DIPG patients, including the 6 patients previously presented at 2018 AACR (Free AACR Whitepaper) Annual Meeting, demonstrated initial symptomatic improvement, and eight of ten had completed radiation, with the remaining 2 of 10 patients continuing radiotherapy. Currently, 9/10 patients remain on study, with the longest time on study of 8.5 months at the time of the report.

Anticipated Near-Term Milestones

2H 2018: Updated results from Phase 1b trial of indoximod plus standard-of-care chemotherapy for patients with newly diagnosed AML expected to be presented

2H 2018: Initial Phase 1 data from NLG802 expected to be presented

1H 2019: Updated results from Phase 1 trial of indoximod plus radio-chemotherapy for pediatric patients with recurrent malignant brain tumors including initial survival data expected to be presented

Organizational Changes
The company has completed an organizational realignment that will support these clinical development efforts within its current financial capacity, substantially cut future expenses, and extend its cash runway into the second half of 2021.
The organizational changes include a reduction in headcount of approximately 30%, and include the following changes to senior leadership, effective immediately:

Jack Henneman has been appointed Chief Administrative Officer for a transition period to end with his retirement from NewLink in November 2018

Carl Langren has been promoted to Chief Financial Officer

Lori Lawley has been promoted to Vice President, Finance and Controller

Brad Powers has been promoted to General Counsel

"We are grateful for the service and contributions made by Jack and all of those who have been a part of the NewLink team. This necessary transition is difficult for our company and our people, and we don’t take these changes lightly. That said, our company will focus its energies on clinical programs in the indications where patients are in the most need and with the best opportunity for clinical success," said Nicholas Vahanian, MD, President.
Revised Cash Guidance
As a result of these measures, the company anticipates its current cash runway to extend into the second half of 2021, excluding any additional financings, proceeds from strategic alliances, the potential receipt of the priority review voucher, or expenditures related to external opportunities. The Company expects to use approximately $10 million per quarter after completing the restructuring.
Financial Results for the Three-Month Period Ended June 30, 2018
Cash Position: NewLink Genetics ended the quarter on June 30, 2018, with cash and cash equivalents totaling $137.1 million compared to $158.7 million for the year ending December 31, 2017.
R&D Expenses: Research and development expenses for the second quarter of 2018 were $12.1 million, a decrease of $6.1 million from $18.2 million for the same period in 2017. The decrease was due primarily to a decrease of $5.6 million in contract research and manufacturing spend, a decrease of $1.1 million in personnel-related and stock

Exhibit 99.1

compensation expense, a $311,000 decrease in supplies, offset by an increase of $741,000 in clinical trial expense and an increase of $128,000 in legal and consulting expense.
G&A Expenses: General and administrative expenses for the second quarter of 2018 were $7.9 million, a decrease of $1.0 million from $8.9 million for the same period in 2017. The decrease was due to a decrease of $313,000 of legal and consulting expense, a decrease of $787,000 in personnel-related and stock compensation expense offset by an increase of $182,000 in supplies and other expense.
Net Loss: NewLink Genetics reported a net loss of $17.3 million or ($0.47) per diluted share for the second quarter of 2018 compared to a net loss of $16.7 million or ($0.57) per diluted share for the second quarter of 2017.
NewLink Genetics ended the quarter with 37,198,100 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 10 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 4478527. 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, suppressing immune response and allowing for immune escape by degrading tryptophan with the resultant production of kynurenine. We hypothesize that immune activation using indoximod based combination immunotherapy can allow responsiveness to chemotherapy and radiation in patients who may otherwise be refractory or have limited benefit. The immuno-stimulatory effects of indoximod impact four main cell types: CD8+ T cells, CD4+ T helper cells, T regulatory cells, and dendritic cells. Indoximod reverses the effects of low tryptophan by increasing the proliferation of CD8+ effector T cells, drives differentiation into CD4+ T helper cells rather than regulatory T cells, and downregulates IDO expression in dendritic cells. Indoximod is being evaluated in combination with treatment regimens including chemotherapy, radiation, checkpoint blockade and cancer vaccines across multiple indications including recurrent pediatric brain tumors, DIPG, and AML.

On July 31, 2018 Geron Corporation (Nasdaq: GERN) reported financial results for the three and six months ended June 30, 2018 (Press release, Geron, JUL 31, 2018, View Source [SID1234528419]).

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Second Quarter and Year to Date 2018 Results

For the second quarter of 2018, the Company reported a net loss of $6.9 million, or $0.04 per share, compared to $6.4 million, or $0.04 per share, for the comparable 2017 period. Net loss for the first six months of 2018 was $14.1 million, or $0.08 per share, compared to $13.6 million, or $0.09 per share, for the comparable 2017 period.

Revenues for the three and six months ended June 30, 2018 were $208,000 and $526,000, respectively, compared to $174,000 and $711,000 for the comparable 2017 periods. Revenues for the three and six months ended June 30, 2018 and 2017 included royalty and license fee revenues under various non-imetelstat license agreements. The Company adopted the new revenue recognition accounting standard as of January 1, 2018 using the modified retrospective transition method. Financial results for the three and six months ended June 30, 2018 are presented under the new accounting standard, but prior period amounts have not been adjusted and continue to be reported under accounting standards used historically. Therefore, there is a lack of comparability to the prior periods presented. As a result, the decrease in revenues for the six months ended June 30, 2018, compared to the same period in 2017, reflects not only a reduction in the number of active non-imetelstat license agreements and decreased product sales from licensees, but also a change in the method accounting. However, the Company does not expect the adoption of the new revenue recognition accounting standard to have a material impact to its financial statements on an ongoing basis.

Total operating expenses for the three and six months ended June 30, 2018 were $7.4 million and $15.2 million, respectively, compared to $6.9 million and $14.9 million for the comparable 2017 periods. Research and development expenses for the three and six months ended June 30, 2018 were $3.2 million and $5.6 million, respectively, compared to $2.5 million and $5.9 million for the comparable 2017 periods. The changes in research and development expenses for the three and six months ended June 30, 2018, compared to the same periods in 2017, primarily reflect the variation in costs for our proportionate share of clinical development expenses under the imetelstat collaboration with Janssen Biotech, Inc. (Janssen). General and administrative expenses for the three and six months ended June 30, 2018 were $4.2 million and $9.6 million, respectively, compared to $4.4 million and $9.1 million for the comparable 2017 periods. The overall increase in general and administrative expenses for the six months ended June 30, 2018, compared to the same period in 2017, primarily reflects the net result of higher legal and consulting costs, partially offset by lower stock-based compensation expense.

Interest and other income for the three and six months ended June 30, 2018 was $717,000 and $1.1 million, respectively, compared to $346,000 and $678,000 for the comparable 2017 periods. The increase in interest and other income for the three and six months ended June 30, 2018, compared to the same periods in 2017, primarily reflects higher yields on the company’s increased marketable securities portfolio.

The Company ended the second quarter of 2018 with $181.4 million in cash and marketable securities. Since December 2017, the Company has raised cumulative net cash proceeds of approximately $87 million from the sales of an aggregate of 23,892,415 shares of common stock under At Market Issuance Sales Agreements (Sales Agreements) after deducting sales commissions and offering expenses payable by Geron. The Company expects these net cash proceeds to provide additional capital structure flexibility under different scenarios. If Janssen elects to continue the collaboration, the funds can potentially support the future shared development of imetelstat and Geron’s business development efforts to diversify its business through in-licensing or acquisitions. If Janssen elects to discontinue the collaboration, and Geron chooses to continue development of imetelstat, the funds can support future development costs, including potentially the start of the Phase 3 portion of IMerge.
Company Events

"We still expect Janssen’s decision whether to continue imetelstat development by the end of the third quarter," said John A. Scarlett, M.D., Geron’s President and Chief Executive Officer. "During the second quarter, we strengthened our balance sheet and made progress on our plans to address either scenario resulting from Janssen’s decision. Therefore, we are confident in our ability to manage our business effectively going forward."

IMbark Status

IMbark is a Phase 2 trial in patients with Intermediate-2 or High Risk myelofibrosis (MF) who have relapsed after or are refractory to prior treatment with a JAK inhibitor. In March 2018, Janssen officially closed the trial to new patient enrollment. In the second quarter of 2018, Janssen initiated a protocol-specified primary analysis of IMbark, which includes an assessment of overall survival. The Company expects that following completion of the protocol-specified primary analysis, Janssen will notify Geron whether it elects to maintain the license rights and continue the development of imetelstat in any indication (the Continuation Decision). Geron expects Janssen to inform the Company of its decision by the end of the third quarter of 2018.

IMerge Status

IMerge is a two-part clinical trial evaluating imetelstat in transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS) who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent, or ESA. The primary efficacy endpoint is the rate of red blood cell transfusion independence lasting at least 8 weeks. Part 1 is a Phase 2, open-label, single-arm trial of imetelstat, and Part 2 is designed to be a Phase 3, randomized, controlled trial. Part 2 has not yet begun.

On June 17, 2018, updated data from the original Part 1 of IMerge was presented at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) held in Stockholm, Sweden. The oral presentation described data as of May 2018 from the first 32 patients enrolled in Part 1 of IMerge with a median follow-up of 95 weeks. These data showed that among the 32 red blood cell transfusion-dependent MDS patients enrolled in Part 1, a subset of 13 patients, who had not received prior treatment with either a hypomethylating agent or lenalidomide and were non-del(5q), exhibited an increased rate and durability of transfusion independence compared to the overall trial population.

The slide presentation from the EHA (Free EHA Whitepaper) conference is available on Geron’s website at www.geron.com/r-d/publications.

Based on preliminary data from Part 1 of IMerge, Janssen expanded new patient enrollment in Part 1 and enrolled approximately 25 additional patients who are naïve to lenalidomide and HMA treatment and are non-del(5q) to increase the experience and evaluate the benefit-risk profile of imetelstat in this refined target patient population. In November 2017, the first patient was dosed in the expanded Part 1 of IMerge and enrollment was completed in February 2018.

Conference Call and Webcast

Geron will host a conference call to discuss second quarter financial results and recent events at 4:30 p.m. ET on Tuesday, July 31, 2018.

Participants may access the conference call live via telephone by dialing domestically +1 (877) 303-9139 or internationally +1 (760) 536-5195. The passcode is 9464589. A live, listen-only webcast will also be available through on the Company’s website at www.geron.com/investors/events. If you are unable to listen to the live call, an archived webcast will be available on the Company’s website for 30 days.

On July 31, 2018 Protalix BioTherapeutics, Inc. (NYSE American:PLX, TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, reported that it will report second quarter 2018 financial results and provide a corporate update on Thursday, August 9, 2018 at 8:30 am ET (Press release, Protalix, JUL 31, 2018, View Source;p=RssLanding&cat=news&id=2360879 [SID1234528393]).

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To participate in the conference call, please dial the following numbers prior to the start of the call: United States: +1-844-358-6760; International: +1-478-219-0004. Conference ID number 9488046.

The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.