On November 7, 2019 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company"), a novel bioelectric medicine company bringing to market its proprietary CellFX System, reported recent corporate developments and financial results for the three- and nine-month periods ended September 30, 2019 (Press release, Pulse Biosciences, NOV 7, 2019, View Source [SID1234550709]).

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Recent Corporate Developments

The Company continues to work with the Food and Drug Administration ("FDA") on its 510(k) submission for the CellFX System in dermatology. On September 23, 2019 the Company submitted its formal response to the FDA’s April 30, 2019 Additional Information ("AI") Letter request. Upon review of the AI Letter responses, the FDA requested responses to two additional questions and the Company has provided the FDA with draft responses to these questions. Following this, the Company and the FDA mutually agreed to temporarily put the 510(k) submission review on hold to allow sufficient time for the FDA to properly review these remaining responses. The Company continues to work collaboratively with the FDA and believes the review process will be completed during the fourth quarter of 2019 and is continuing to prepare for a potential 510(k) clearance.

In a separate press release today, the Company announced the appointment of Sandra Gardiner as Executive Vice President and Chief Financial Officer effective November 18, 2019. Ms. Gardiner succeeds Brian Dow who has served as our CFO since November 2015.

The Company’s Nano-Pulse Stimulation (NPS) technology was featured prominently during the American Society for Dermatologic Surgery ("ASDS") annual meeting held October 24-27, in Chicago. The following presentations all took place on Thursday October 24:

Investigator Dr. Girish Munavalli presented the latest clinical investigational study data on Sebaceous Hyperplasia (SH) and Warts in two separate oral abstract presentations. The Sebaceous Hyperplasia presentation provided new longer-term data on our original SH clinical study showing durability of efficacy out to at least 12-months with continued high patient satisfaction. The presentation also provided insights into our second SH clinical study including data demonstrating the ability of the CellFX System to clear SH lesions with minimal residual skin effects in a dose dependent manner.

In a second presentation Dr. Munavalli presented data on our wart program, including clinical data and experience from our NPS Wart Feasibility Study followed by early data from our current Warts Pivotal Study. This Pivotal Study allows for multiple NPS treatments to clear the warts so the findings discussed represent an early look at the data.

Investigator Dr. Mark Nestor presented data on the first two patients enrolled in the feasibility acne study on severe back acne. Dr. Nestor reported reductions in acne lesion count of the NPS treated area when compared to control at 90-day follow-up in both patients with very good healing response.

Dr. Tom Rohrer gave an invited presentation in the Emerging Therapies Plenary Session and presented an overview of NPS technology and the various NPS clinical programs to the ASDS audience.

"Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Sebaceous Gland Hyperplasia" with lead author Girish Munavalli, MD, MHS, FACMS, has been published online by the Journal of Dermatologic Surgery. This peer reviewed paper outlines the results, findings and observations from the Company’s clinical study evaluating the safety and efficacy of NPS for the treatment of Sebaceous Hyperplasia and can be found online at: View Source

"Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Seborrheic Keratoses" with lead author George J. Hruza, MD, MBA, FAAD, has been accepted for publication in an upcoming edition of the Journal of Dermatologic Surgery and outlines the results, findings and observations from our clinical study evaluating the safety and efficacy of NPS for the treatment of Seborrheic Keratosis.

The Company has enrolled a total of 35 patients in its CellFX Warts Pivotal Study. The CellFX Warts Pivotal Study is a prospective, non-randomized, multicenter study evaluating the safety and effectiveness of the CellFX System in up to 60 patients with non-genital cutaneous warts. The Company expects to complete enrollment by the end of 2019.

Financial Highlights

Cash, cash equivalents, and investments totaled $34.5 million at September 30, 2019, compared to $59.6 million at December 31, 2018. Cash use totaled $8.1 million for the third quarter of 2019 compared to cash use of $10.2 million for the second quarter of 2019 and $6.8 million for the first quarter of 2019.

Operating expenses for the three-month period ended September 30, 2019 totaled $12.0 million, compared to $10.9 million for the three-month period ended September 30, 2018. Operating expenses for the three-month period ended September 30, 2019 included non-cash stock-based compensation of $2.7 million, compared to non-cash stock-based compensation of $3.4 million for the three-month period ended September 30, 2018.

Operating expenses for the nine-month period ended September 30, 2019 totaled $34.0 million, compared to $28.9 million for the nine-month period ended September 30, 2018. Operating expenses for the nine-month period ended September 30, 2019 included non-cash stock-based compensation of $7.7 million, compared to non-cash stock-based compensation of $10.0 million for the nine-month period ended September 30, 2018.

Net loss for the three-month period ended September 30, 2019 totaled $11.7 million compared to $10.8 million for the three-month period ended September 30, 2018. Net loss for the nine-month period ended September 30, 2019 totaled $33.2 million compared to $28.6 million for the nine-month period ended September 30, 2018.

Conference Call Details

Pulse Biosciences will host an investor call today at 1:30 p.m. PDT / 4:30 p.m. EDT. The telephone dial-in number for the call is (844) 494-0190 (U.S. toll-free) or (508) 637-5580 (international) using Conference ID 7381116. Listeners will also be able to access the call via webcast available on the Investors section of the Company’s website at www.PulseBiosciences.com.

On November 7, 2019 Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, reported its financial results and operational highlights for the third quarter and nine months ended September 30, 2019 (Press release, Novavax, NOV 7, 2019, View Source [SID1234550757]).

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"The recent initiation of our pivotal NanoFlu Phase 3 clinical trial in older adults represents an important milestone toward gaining approval for our novel vaccine candidate," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "Enrollment in the trial is complete and we are well positioned to deliver top-line clinical trial data in the first quarter of 2020. For ResVax, discussions with potential partners and other stakeholders are ongoing to determine the best path forward to protect vulnerable infants against RSV, for which there is currently no vaccine."

Third Quarter 2019 and Subsequent Operational Highlights

NanoFlu Program

·Novavax initiated a pivotal Phase 3 clinical trial for NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate, and completed enrollment of 2,652 healthy older adults across 19 U.S. clinical sites. The primary objective of the randomized, observer-blinded, active-controlled trial is to demonstrate non-inferior immunogenicity as measured by hemagglutination inhibition (HAI) titers of vaccine homologous influenza strains and safety compared against a licensed vaccine, Fluzone Quadrivalent.

·Top-line results from this Phase 3 clinical trial are expected in the first quarter of 2020 and would support a subsequent U.S. biologics license application (BLA) and licensure of NanoFlu using the U.S. Food and Drug Administration’s (FDA) accelerated approval pathway.

·On September 19, 2019, a Presidential Executive Order was issued that mandates the modernization of influenza vaccines for the benefit of U.S. national security and public health. This Executive Order reinforces the strategic value of the NanoFlu program in particular because, as a non-egg based vaccine formulated using recombinant nanoparticle technology and combined with a safe and potent adjuvant, NanoFlu has all the characteristics of the better influenza vaccine mandated by the Order. The full Executive Order is available here.

ResVax Program

·The FDA and the European Medicines Agency (EMA) have both recommended that Novavax conduct an additional Phase 3 clinical trial to confirm the efficacy of ResVax. Novavax is in continuing discussions with both global regulatory authorities and with potential partners to explore the opportunity to bring ResVax to market globally.

·Novavax presented additional efficacy and safety findings from the program at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual meeting in August and at the World Vaccine Congress – Europe last week. The presentations included new observations based on the recently completed analyses of the 1-year safety data, including a 56.9% (95% CI 34.5, 71.7%) reduction in the incidence of serious adverse events (SAEs) diagnosed as pneumonia, with confirmation by chest x-ray, that extended through the first year of life.

Ebola Program

·The Journal of Infectious Diseases published a peer-reviewed manuscript detailing the positive results from Novavax’ Phase 1 clinical trial in healthy adults of the Ebola virus glycoprotein vaccine candidate. Additional details of the manuscript are available here.

Corporate

·Novavax and Catalent Biologics closed the transaction under which Catalent purchased Novavax’ manufacturing equipment and related assets for approximately $18 million, assumed the property leases to two Novavax product development and manufacturing facilities and hired approximately 100 of Novavax’ manufacturing and quality employees. In addition, Catalent has begun to provide process development and manufacturing services for specified Novavax programs.

Financial Results for the Three and Nine Months Ended September 30, 2019

Share and per share data have been restated to reflect the reverse stock split that was completed in May 2019.

Novavax reported a net loss of $18.0 million, or $0.74 per share, for the third quarter of 2019, compared to a net loss of $44.6 million, or $2.33 per share, for the third quarter of 2018. For the nine months ended September 30, 2019, the net loss was $100.9 million, or $4.43 per share, compared to a net loss of $135.4 million, or $7.42 per share, for the same period in 2018. The 2019 net losses include a gain of $9.0 million recorded as a result of the Catalent transaction.

Novavax revenue in the third quarter of 2019 was $2.5 million, compared to $7.7 million in the same period in 2018. This 68% decrease was driven by the completion of enrollment of participants in the Prepare trial in the second quarter of 2018.

Research and development expenses decreased 55% to $18.6 million in the third quarter of 2019, compared to $41.3 million in the same period in 2018. This decrease was primarily due to decreased development activities of ResVax, lower employee-related costs and other cost savings due to the Catalent transaction.

General and administrative expenses slightly decreased to $7.9 million in the third quarter of 2019, compared to $8.3 million for the same period in 2018.

Interest income (expense), net for the third quarter of 2019 was ($3.1) million, compared to ($2.7) million for the same period of 2018.

As of September 30, 2019, Novavax had $75.9 million in cash, cash equivalents, marketable securities and restricted cash, compared to $103.9 million as of December 31, 2018. Net cash used in operating activities for the first nine months of 2019 was $112.9 million, compared to $139.6 million for same period in 2018.

Conference Call

Novavax will host its quarterly conference call today at 4:30 p.m. ET. The dial-in numbers for the conference call are (877) 212-6076 (Domestic) or (707) 287-9331 (International), passcode 5956098. A replay of the conference call will be available starting at 7:30 p.m. ET on November 7, 2019 until 7:30 p.m. ET on November 14, 2019. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 5956098.

A webcast of the conference call can also be accessed via a link on the home page of the Novavax website (novavax.com) or through the "Investor Info"/"Events" tab on the Novavax website. A replay of the webcast will be available on the Novavax website until February 7, 2020.

About Influenza

Influenza is a world-wide infectious disease that causes illness in humans with symptoms ranging from mild to life-threatening or even death. Serious illness occurs not only in susceptible populations such as infants, young children and older adults, but also in the general population largely because of infection by continuously evolving strains of influenza which can evade the existing protective antibodies in humans. An estimated one million deaths globally each year are attributed to influenza. Current estimates for seasonal influenza vaccine growth in the top seven markets (U.S., Japan, France, Germany, Italy, Spain and UK), show a potential increase from approximately $3.2 billion in 2015 to $5.3 billion by 2025.

About NanoFlu and Matrix-M

NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax’ patented saponin-based Matrix-M adjuvant, which has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes.

About Accelerated Approval

Accelerated approval may be granted for certain biological products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments. Such an approval will be based on adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. For seasonal influenza vaccines, the hemagglutination inhibition (HAI) antibody response may be an acceptable surrogate marker of activity that is reasonably likely to predict clinical benefit. To be considered for accelerated approval, a biologics license application for a new seasonal influenza vaccine should include results from one or more well-controlled studies designed to meet immunogenicity endpoints and a commitment to conduct confirmatory post-marketing studies of clinical effectiveness in preventing influenza.

About RSV in Infants

Globally, RSV (respiratory syncytial virus) is the leading viral cause of severe lower respiratory tract disease in infants and young children. It is the second leading cause of death in children under one year of age. Estimated annual hospitalizations of 1.4 million and an estimated 27,300 in-hospital deaths were due to RSV acute lower respiratory infection in children under six months of age. RSV results in a total global economic burden of $6.2 billion annually.

In the U.S., RSV is the leading cause of hospitalization of infants, with estimated annual hospitalizations of up to 76,000. While RSV can impact all infants, babies under six months of age are among those at highest risk, as approximately 77% of all first-year RSV infections occur before six months. In the U.S., the total economic burden is $2.7 billion annually.

About ResVax

ResVax is an RSV fusion (F) protein recombinant nanoparticle vaccine with aluminum phosphate as an adjuvant. It is being developed to protect infants from RSV disease via maternal immunization, which may offer the best method of protection from RSV disease in infants through the first months of life. ResVax is being evaluated in Prepare, a global Phase 3 clinical trial in 4,636 pregnant women, at least 3,000 of whom received the vaccine, and their infants. Prepare is supported by an $89.1 million grant from the Bill & Melinda Gates Foundation (BMGF).

On November 7, 2019 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported that Genentech, a member of the Roche Group, has exercised its final option for an exclusive target under the companies’ collaboration agreement to develop and commercialize novel NK cell engager-based immunotherapeutics generated from Affimed’s ROCK platform to treat multiple cancers (Press release, Affimed, NOV 7, 2019, View Source [SID1234550789]). The target selection triggers a milestone payment, in an undisclosed amount, to Affimed from Genentech.

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"The designation of the final target marks another milestone for the collaboration, which brings together Genentech’s deep understanding of cancer immunology with Affimed’s expertise in drug discovery and development of innate cell engagers," said Dr. Adi Hoess, Chief Executive Officer of Affimed. "We look forward to achieving further progress toward generating novel therapies that leverage the full potential of the innate immune system to help people living with cancer."

About the Strategic Collaboration Agreement with Genentech

Affimed’s strategic, multi-target collaboration with Genentech was announced in August 2018. Under this agreement, Affimed applies its fit-for-purpose Redirected Optimized Cell Killing (ROCK) platform and engineering expertise to discover and advance NK cell engager-based immunotherapeutics against certain targets selected by Genentech. Affimed and Genentech collaborate on the discovery, early research and late-stage research phases. Genentech is responsible for clinical development and commercialization worldwide. Affimed received $96 million in upfront and committed funding from Genentech in the fourth quarter of 2018 and may be eligible to receive up to an additional $5 billion in development, regulatory and commercial milestone payments, plus royalties on sales of any developed products.

On November 7, 2019 Proteostasis Therapeutics, Inc. (NASDAQ:PTI), a clinical stage biopharmaceutical company dedicated to the discovery and development of groundbreaking therapies to treat cystic fibrosis (CF) and other diseases caused by dysfunctional protein processing, reported financial results for the third quarter ended September 30, 2019 and provided a corporate update (Press release, Proteostasis Therapeutics, NOV 7, 2019, View Source [SID1234550844]).

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"With equally strong demand from both US and ex-US clinical centers, we were able to complete enrollment in a little over four months for our 28-day global Phase 2 study of our doublet and triplet cystic fibrosis transmembrane conductance regulator (CFTR) combinations, and we now expect to report top line results later this quarter," said Meenu Chhabra, President and Chief Executive Officer of Proteostasis Therapeutics. "CFTR modulator therapy is on the threshold of transforming CF from a life limiting disease into a chronic condition, increasing life span and quality of life. Yet standard of care CFTR modulator treatment still leaves behind many people with CF, as tolerability, efficacy, access and eligibility remain disparate across patient populations. PTI is committed to delivering additional CFTR modulator treatment options to address these significant unmet needs."

Recent Highlights and Upcoming Milestones

Earlier this week, PTI announced the completion of enrollment in the Company’s 28-day, Phase 2 study evaluating its proprietary doublet (PTI-808 and PTI-801) and triplet (PTI-808, PTI-801 and PTI-428) CFTR modulator combinations, at doses selected based on the totality of dose range finding data from approximately 250 CF subjects studied thus far. The study design targeted up to 30 F508del homozygous and up to 30 F508del heterozygous subjects. Study endpoints include safety, changes in sweat chloride concentration and changes in percent predicted FEV1 (ppFEV1). Due to rapid enrollment from centers in the United States, Canada, Western Europe, and New Zealand, data from the study are now expected in the fourth quarter of 2019 instead of the first quarter of 2020.

Data from the Company’s CF clinical development programs were recently highlighted at the North American Cystic Fibrosis Conference in presentations delivered by Patrick Flume, M.D., Professor of Medicine and Pediatrics, Medical University of South Carolina and Jennifer L. Taylor-Cousar, M.D., M.S.C.S., Associate Professor of Medicine and Pediatrics, and Co-Director and CF Therapeutics Development Network Director of the Adult CF Program at National Jewish Health.

Last month, PTI hosted a cystic fibrosis patient summit on the disparity in access to CFTR modulator treatments. The event featured members of the CF community, including thought leaders, people with CF and CF advocates, and panel discussions focused on current unmet needs in CF.

In July, PTI announced the appointment of Geoffrey S. Gilmartin, M.D., M.M.Sc., as the Company’s Chief Medical Officer (CMO), and Andrey E. Belous, M.D., Ph.D., as a Senior Medical Director. Dr. Gilmartin served previously as the medical lead for the Kalydeco label expansion program at Vertex Pharmaceuticals Inc. Dr. Belous joined the Company from Galapagos NV, where he most recently served as a Medical Director for the Company’s Phase 3 program in Idiopathic Pulmonary Fibrosis (IPF).

Third Quarter 2019 Financial Results

Proteostasis reported a net loss of approximately $12.8 million for the three months ended September 30, 2019, as compared to a net loss of $18.4 million for the same period in the prior year.

There was no revenue for the three months ended September 30, 2019, as compared to $1.1 million for the same period in the prior year. The decrease of $1.1 million is due to the termination of the Company’s collaboration agreement with Astellas.

Research and development expenses for the three months ended September 30, 2019 were $10.1 million, as compared to $15.6 million for the same period in the prior year. The decrease was primarily due to a decrease in clinical-related research activities.

General and administrative expenses for the third quarter of 2019 were $3.2 million, as compared to $4.2 million for the same period in the prior year. The decrease in general and administrative expenses in these periods was due primarily to lower professional fees and facility expenses.

Cash, cash equivalents and short-term investments totaled $77.8 million as of September 30, 2019, compared to $88.0 million as of June 30, 2019. We believe that our existing cash, cash equivalents and short-term investments are sufficient to fund our operations into 2021, allowing us to complete our Phase 2 study and fund activities supporting our pathway to product registrations.

On November 6, 2019 NewLink Genetics Corporation (NASDAQ:NLNK) reported financial results for the third quarter ended September 30, 2019 and provided an update on corporate activities (Press release, NewLink Genetics, NOV 6, 2019, View Source [SID1234550399]).

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"We are excited about the proposed merger with Lumos Pharma that we announced at the close of the third quarter and continue to advance the process required to close the transaction," commented Brad Powers, General Counsel and member of NewLink’s Office of the CEO. "We believe this merger positions the company to improve therapeutic options for patients with pediatric growth hormone deficiency and other rare and neglected diseases, and to bring greater value to our shareholders."

Eugene Kennedy, MD, Chief Medical Officer and member of NewLink’s Office of the CEO added, "We are also pleased by the FDA’s recent acceptance of the biologic licensing application for priority review of our partnered investigational Ebola vaccine, which we licensed to Merck in 2014. We are encouraged, as well, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending a conditional marketing authorization for V920 Ebola Zaire vaccine. We believe these actions demonstrate the urgency with which regulatory bodies are addressing this deadly disease in order to help the affected individuals and communities."

Proposed Merger and Related Milestones

On September 30, 2019, NewLink announced its intent to merge with Lumos Pharma, a private clinical-stage biopharmaceutical company targeting rare and neglected diseases. Under the terms of the merger agreement, Lumos and NewLink stockholders will each own approximately 50% of the combined company which will be renamed "Lumos Pharma" at the close of the transaction. Rick Hawkins, current CEO of Lumos Pharma, is expected to become CEO of the combined company. The proposed merger has been approved by the Boards of both companies and the major stockholders of Lumos Pharma and NewLink’s largest stockholder has entered into a support agreement with NewLink to vote in favor of various proposals relating to the Merger.

The combined company would focus initially on the development of Lumos Pharma’s lead product candidate, LUM-201 (ibutamoren), an oral growth hormone (GH) secretagogue targeting pediatric growth hormone deficiency (PGHD) and other rare endocrine disorders. If approved, LUM-201 has the potential to be the first orally administered growth hormone stimulating therapy for PGHD, a well-established and sizable market where daily recombinant human growth hormone injections represent current standard-of-care therapy.

The initiation of a Phase 2b trial for LUM-201 in a subset of PGHD patients meeting certain predictive enrichment markers (PEMs) is anticipated in mid-2020. The combined company is expected to have resources sufficient to support clinical development through the readout of this planned Phase 2b trial. Additional target indications are being evaluated for LUM-201 clinical development, including Turner Syndrome and children born Small for Gestational Age (SGA).

NewLink will file a proxy statement with the Securities and Exchange Commission (SEC) providing additional information about the proposed merger. The transaction is expected to close in the first quarter of 2020, subject to the satisfaction of customary closing conditions, including approval of certain proposals by the stockholders of NewLink.

Additional Updates

The combined company may receive additional, non-dilutive financing should the U.S. Food and Drug Administration (FDA) approve NewLink’s Ebola vaccine V920 partnered with Merck Sharp & Dohme Corp. (Merck). On September 17, 2019, Merck announced that the FDA has accepted its biologics license application (BLA) and granted priority review for the investigational Ebola vaccine V920 and the Prescription Drug User Fee Act (PDUFA), or target action date, is set for March 14, 2020. If the vaccine receives approval by the FDA, a priority review voucher will be issued, in which the Company owns a substantial interest and which the Company plans to monetize.

On October 18, 2019, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use(CHMP) adopted a positive opinion recommending a conditional marketing authorization for investigational V920 Ebola Zaire vaccine (rVSV∆G-ZEBOV-GP), as confirmed by our partner, Merck (NYSE:MRK). This Committee’s recommendation will now be reviewed by the European Commission (EC) for a centralized marketing authorization of the vaccine (brand name ERVEBO) across EU member countries.

Updated Phase 1b results for indoximod for the cohort of pediatric patients with newly diagnosed treatment-naïve diffuse intrinsic pontine glioma (DIPG) has been accepted for presentation at the upcoming ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2019, 11-14 December 2019, Geneva, Switzerland. NewLink expects to continue to evaluate its oncology portfolio to determine value creation opportunities.

Financial Results for the Three-Month Period Ended September 30, 2019

Restructuring: On September 30, 2019, NewLink Genetics announced it had adopted a restructuring plan to reduce its headcount by approximately 60% to align with future priorities and to conserve resources. In conjunction with the restructuring and the departures of our former CEO and President, the company recorded restructuring and severance charges of $4.5 million during the third quarter.

Cash Position: NewLink Genetics ended the quarter on September 30, 2019, with cash and cash equivalents totaling $98.5 million compared to $120.7 millionDecember 31, 2018.

R&D Expenses: Research and development expenses for the third quarter of 2019 were $7.0 million, a decrease of $546,000 from $7.6 million for the same period in 2018. The decrease was primarily due to reductions of $1.1 million in personnel-related and stock compensation expense, $255,000 in contract research and manufacturing spend, and $333,000 in legal and consulting and supplies expense, offset by increases of $1.1 million in restructuring costs and $87,000 in clinical trial and licensing expense.

G&A Expenses: General and administrative expenses in the third quarter of 2019 were $8.3 million, an increase of $691,000 from $7.6 million for the same period in 2018. The increase was due primarily to increases of $2.0 million in restructuring and severance expense, and $1.2 million in legal and consulting expense, offset by decreases of $1.7 million in stock compensation expense, $431,000 in personnel-related expense, and $353,000 in supplies.

Net Loss: NewLink Genetics reported a net loss of $14.5 million or ($0.39) per diluted share for the third quarter of 2019 compared to a net loss of $7.4 million or ($0.20) per diluted share for the third quarter of 2018.

NewLink Genetics ended Q3 2019 with 37,314,076 shares outstanding.

Conference Call and Webcast Details

The Company has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss its financial results and to give an update on clinical and business development activities.

Access to the live conference call is available five minutes prior to the start of the call by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international). 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 through the link View Source 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 3794399. The replay will be available for two weeks from the date of the call.