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.

On July 31, 2018 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported enrollment has opened for a physician-sponsored clinical trial of WP1066 for the treatment of glioblastoma and brain metastases in adults (Press release, Moleculin, JUL 31, 2018, View Source [SID1234528366]).

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"We have been eagerly awaiting the beginning of this physician sponsored clinical trial," commented Walter Klemp, Chairman and CEO of Moleculin. "The trial, which is now listed on clinicaltrials.gov and being conducted at MD Anderson Cancer Center, is now open for enrollment. This is our first investigator initiated trial of WP1066 and an important milestone. Given the unique potential of WP1066, we expect more trials to follow."

The goal of this clinical research study is to find the highest tolerable dose of WP1066 that can be given to patients with recurrent (has returned after treatment) cancerous brain tumors or melanoma that has spread to the brain. The safety of this drug will also be studied.

WP1066 is designed to target the STAT3 pathway in cancer cells, which makes these cells divide, increases new blood vessels to the tumor, causes the cancer cells to move throughout the body and brain, and avoids them being detected by the immune system. We believe that targeting this pathway may cause the immune system to kill the cancer cells.

On July 31, 2018 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the Company will present at the upcoming Canaccord Genuity Growth Conference. The presentation is scheduled for 8:30 a.m. ET on August 8, 2018 (Press release, ImmunoGen, JUL 31, 2018, View Source [SID1234528365]).

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A webcast of the presentation will be accessible live through the "Investors" section of the Company’s website, www.immunogen.com; a replay will be available in the same location for approximately two weeks.