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Vaxart Announces Second Quarter 2019 Financial Results and Provides Corporate Update

On August 8, 2019 Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, reported financial results for the second quarter ended June 30, 2019 (Press release, Vaxart, AUG 8, 2019, View Source [SID1234538458]).

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"We have made significant progress this quarter, achieving a number of important milestones. We completed enrollment in our Phase 1b bivalent norovirus vaccine study and we expect to have topline results by October of this year," said Wouter Latour, M.D., chief executive officer of Vaxart. "Norovirus causes $60 billion in global healthcare related costs annually, and our oral tablet vaccine would be ideal to help protect vulnerable populations such as older adults and the very young. We remain committed to developing the norovirus vaccine, and we are now preparing to start a Phase 2 study with our bivalent norovirus vaccine in 2020, assuming we achieve positive results in the current Phase 1b trial."

"With regard to universal flu, the collaboration with Janssen is an important endorsement of our oral vaccine platform and could position us as a key player in the future of influenza vaccine development. In parallel, we continue our efforts to advance our own oral seasonal flu vaccine, which demonstrated the potential to provide better protection than currently marketed injectable vaccines, such as FluzoneTM, in a human challenge study. Given our focus on the bivalent norovirus and universal flu vaccine programs, we have deprioritized the monovalent norovirus vaccine challenge study and now plan to file our human papilloma virus (HPV) Investigational New Drug application (IND) in 2020," continued Dr. Latour.

Recent Corporate Highlights:

● Completed enrollment in the Phase 1b bivalent norovirus vaccine clinical trial. The vaccine consists of an oral norovirus GI.1 vaccine tablet and an oral norovirus GII.4 vaccine tablet administered concurrently. The trial is designed to evaluate safety and immunogenicity and Vaxart expects to report topline data in early Q4 2019.

● Entered into a research collaboration agreement with Janssen Vaccines & Prevention B.V. (Janssen) to evaluate Vaxart’s proprietary oral vaccine platform for the Janssen universal influenza vaccine program.

● Priced an underwritten public offering which closed in April. As of June 30, 2019, the aggregate gross proceeds were $10.0 million.

● Entered into an agreement with Lonza Houston to supply vaccine for the planned Phase 2 bivalent norovirus study in 2020.

● Presented preclinical data at the 29th European Congress of Clinical Microbiology and Infectious Diseases in Amsterdam which showed that Vaxart’s oral quadrivalent seasonal influenza vaccine conferred 100% protection against a lethal H5N1 pre-pandemic influenza challenge in ferrets, while in the Fluzone group only 62% of the animals survived.

● Published the comprehensive results from a preclinical trial of Vaxart’s chikungunya vaccine in the peer reviewed journal, Vaccine. The preclinical results demonstrated that Vaxart’s vaccine candidate induced significant neutralizing antibodies against chikungunya virus as well as protective efficacy against virus-induced pathologic changes.

● Presented preclinical results of Vaxart’s oral Respiratory Syncytial Virus (RSV) vaccine in a poster presentation at the American Society of Microbiology 2019, demonstrating the Vaxart vaccine induces respiratory mucosal memory and protection against RSV infection in cotton rats.

Following a review of the development strategy for norovirus, Vaxart has deprioritized the monovalent GI.1 challenge study. Consequently, the Company is preparing to initiate a Phase 2 safety and immunogenicity study with Vaxart’s bivalent norovirus vaccine in 2020, to be followed by a Phase 3 efficacy study, assuming FDA concurrence.

Financial Results for the Three Months Ended June 30, 2019

● Vaxart reported a net loss of $5.6 million for the second quarter of 2019 compared to $8.9 million for the second quarter of 2018. The principal reasons for the decrease were the absence of a $1.6 million one-off non-cash impairment charge recorded in the second quarter of 2018 and a reduction in research and development expenditure.

● Vaxart ended the quarter with cash and cash equivalents of $16.3 million compared to $8.4 million at March 31, 2019. The increase was primarily due to the $8.7 million net raised as a result of the underwritten offering in April 2019, partially offset by cash used in operations.

● Revenue for the quarter was $85,000 compared to $608,000 in the second quarter of 2018. The decrease was almost entirely due to the absence of revenue of $520,000 from the BARDA contract which ended in 2018.

● Research and development expenses were $3.7 million for the quarter compared to $5.0 million for the second quarter of 2018. The decrease was mainly due to the absence of clinical trials costs for teslexivir and costs incurred for the now-completed BARDA contract, partially offset by higher clinical trial and manufacturing costs incurred in the Company’s norovirus program.

● General and administrative expenses were $1.4 million for the quarter compared to $1.8 million for the second quarter of 2018. The decrease was mainly due to lower legal costs and a reduction in personnel costs.

Spectrum Pharmaceuticals Reports Second Quarter 2019 Financial Results and Pipeline Update

On August 8, 2019 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported financial results for the three-month period ended June 30, 2019 (Press release, Spectrum Pharmaceuticals, AUG 8, 2019, View Source [SID1234538457]).

"We’ve made significant progress on our pipeline in the last few months," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "Most notably, we completed enrollment in our first two poziotinib cohorts in the ZENITH20 study and expect to see results from cohort 1 in the fourth quarter. Based on strong science, we’ve expanded the poziotinib development program to include additional areas of high unmet medical need in lung cancer. We also had a productive meeting with the FDA and expect to submit the ROLONTIS BLA in the fourth quarter."

Pipeline Overview:

Poziotinib, an irreversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations:

The cornerstone poziotinb ZENITH20 trial currently consists of seven cohorts of patients with non-small cell lung cancer (NSCLC).
Cohorts Fully Enrolled
Cohort 1: Previously treated patients with EGFR exon 20 insertion mutation; topline results expected in the fourth quarter 2019
Cohort 2: Previously treated patients with HER2 exon 20 insertion mutation; topline results expected in mid-2020
Cohorts Currently Enrolling
Cohort 3: Treatment naïve patients with EGFR exon 20 insertion mutation
Cohort 4: Treatment naïve patients with HER2 exon 20 insertion mutation
Cohort 5: Previously treated or treatment naïve patients with EGFR or HER2 exon 20 insertion mutation
Cohort 6: Previously treated first-line osimertinib patients with acquired EGFR mutations
Cohort 7: Previously treated patients with atypical EGFR or HER2 mutation
Spectrum expects to initiate a basket study in H2 2019.
ROLONTIS (eflapegrastim), a novel long-acting GCSF:

Integrated data from both Phase 3 ROLONTIS clinical trials with 643 patients were presented in a poster session at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2019 annual meeting.
The analysis found that integrated efficacy and safety data from the two identically designed Phase 3 trials – ADVANCE and RECOVER – were consistent with results from the individual trials, demonstrating that ROLONTIS was non-inferior to pegfilgrastim in the reduction of duration of severe neutropenia (DSN) in all four cycles of treatment.
Spectrum met with the FDA and expects to submit the ROLONTIS BLA in the fourth quarter of 2019.
Business Development

In May 2019, Spectrum completed an asset purchase and license agreement with ImmunGene, Inc., a privately held biotechnology company.
The deal includes an exclusive license for the intellectual property related to the FIT antibody-interferon fusion technology drug delivery platform and two innovative early-stage drug candidates derived from the platform.
Originally developed by scientists at UCLA, the FIT platform fuses interferon with a monoclonal antibody providing a mechanism for targeting many different tumor antigens and has the potential for broad application in oncology.
Three-Month Period Ended June 30, 2019 (All numbers are from Continuing Operations and are approximate)

GAAP Results

Spectrum recorded a loss of $28.8 million, or a loss of $0.26 per basic and diluted share, in the three-month period ended June 30, 2019, compared to income of $14.9 million, or $0.15 income per basic share and $0.14 per diluted share, in the comparable period in 2018. Total research and development expenses were $17.0 million in the quarter, as compared to $16.6 million in the same period in 2018. Selling, general and administrative expenses were $17.2 million in the quarter, compared to $16.4 million in the same period in 2018.

The company ended the quarter with cash, cash equivalents, restricted cash, and marketable securities of $282 million.

Non-GAAP Results

Spectrum recorded a non-GAAP loss of $25.2 million, or a non-GAAP loss of $0.23 per basic and diluted share, in the three-month period ended June 30, 2019, compared to a non-GAAP loss of $28.8 million, or a non-GAAP loss of $0.28 per basic and diluted share, in the comparable period in 2018. Non-GAAP research and development expenses were $13.2 million, as compared to $15.4 million in the same period of 2018. Non-GAAP selling, general and administrative expenses were $13.7 million, as compared to $13.8 million in the same period in 2018.

Conference Call:

Thursday, August 8, 2019 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic: (877) 837-3910, Conference ID# 5378656
International: (973) 796-5077, Conference ID# 5378656

This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: View Source on August 8, 2019 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

Physicians’ Education Resource® Announces Scott Gottlieb as Keynote Speaker for the 37th Annual Chemotherapy Foundation Symposium Innovative Cancer Therapy for Tomorrow®

On August 8, 2019 Physicians’ Education Resource (PER), a worldwide leading resource for continuing medical education (CME), named public health expert and former commissioner of the Food and Drug Administration (FDA) Scott Gottlieb, M.D., as the keynote speaker for the 37th Annual Chemotherapy Foundation Symposium Innovative Cancer Therapy for Tomorrow (Press release, Physicians’ Education Resource, AUG 8, 2019, View Source [SID1234538456]). This year’s keynote presentation will take place on Thursday, Nov. 7 at 11:50 AM, the New York Marriott Marquis in New York City.

"We are excited to have Dr. Gottlieb as the keynote speaker for this year’s Chemotherapy Foundation Symposium (CFS) annual meeting," said Phil Talamo, president of PER. "Gottlieb is an expert in the field of health care access and public health advocacy, and his legacy at the FDA truly aligns with the meeting’s spirit of Innovative Cancer Therapy for Tomorrow as we pave the way for the future of cancer care."

Gottlieb is a physician and served as the 23rd commissioner of the FDA from 2017-2019. His work focuses on advancing public health through developing and implementing innovative approaches to improving medical outcomes, reshaping health care delivery and expanding consumer choice and safety. Under his leadership, the FDA advanced new frameworks for the modern, safe and effective oversight of gene therapies, cell-based regenerative medicines, targeted drugs and digital health devices.

"With improvements in detection and monitoring, plus the discovery of new therapeutic options, we are changing the way cancer is treated. Now, more than ever, we are creating new advancements for the care of all patients with this disease," said Dr. Gottlieb.

Gottlieb is widely published in leading medical journals and periodicals, including The Wall Street Journal, The New York Times and The Washington Post. Fortune recognized him as one of the World’s 50 Greatest Leaders in 2018 and 2019, and he was named one of Time’s Health Care 50, which celebrates those who have transformed health care, in 2018.

The 37th Annual CFS activity co-chairs — Adam M. Brufsky, M.D., Ph.D.; Benjamin P. Levy, M.D.; and William K. Oh, M.D. — will be joined by 100 world-renowned experts who will provide attendees with expert insights into the latest developments in cancer therapeutics, offering an unparalleled opportunity to learn how innovative approaches fit into existing treatment paradigms to optimize care and outcomes for their patients with cancer.

Bicycle Therapeutics Reports Second Quarter 2019 Financial Results and Provides Clinical Update

On August 8, 2019 -Bicycle Therapeutics plc, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycles) product platform, reported financial results for the second quarter ended June 30, 2019 and provided a clinical update (Press release, Bicycle Therapeutics, AUG 8, 2019, View Source [SID1234538455]).

"The second quarter of this year was marked by the completion of our initial public offering, placing us in a solid financial position to advance our novel pipeline of Bicycle drug candidates through the clinic," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "We are pleased with the progress that our pipeline has made over the last quarter, including BT1718, which continues to progress in Phase I dose escalation. We believe that Bicycles, because of their low molecular weight and high affinity and selectivity, could provide meaningful efficacy to patients suffering from cancer and could avoid the toxicities associated with other classes of highly potent anti-cancer drugs, and we look forward to providing updates on our progress."

Second Quarter 2019 and Recent Highlights

Provided Update on the Phase I/IIa Trial Evaluating Lead Asset BT1718 in Patients with Advanced Solid Tumors. Today, Bicycle announced that in the 25 mg/m2 once weekly cohort, no dose limiting toxicities were observed, and the decision was made to continue with dose escalation.
Announced Changes to the Board of Directors. In July 2019, Bicycle announced changes to the composition of its Board of Directors, including the appointment of pharmaceutical industry veteran Richard N. Kender and life sciences financing professional Janice Bourque, as well as an orderly transition for four board members to depart over the next twelve months, which will result in a reduction of the Company’s board size while enhancing its scientific and U.S. public company board expertise.
Announced Positive Topline Results from Oxurion’s Phase I Trial Using Novel Bicycle-based Plasma Kallikrein Inhibitor for the Treatment of Diabetic Macular Edema. In July 2019, Bicycle announced the successful completion of Oxurion’s Phase I clinical trial evaluating the safety and tolerability of a single intravitreal injection of THR-149, a novel Bicycle-based plasma kallikrein (PKal) inhibitor, in patients with diabetic macular edema (DME). No dose-limiting toxicities or drug-related adverse events were reported. A rapid onset of action was observed from Day 1, with an increasing average improvement in patients’ best corrected visual acuity (BCVA) of up to 7.5 letters at Day 14. This activity was maintained with an average improvement in BCVA of 6.5 letters at Day 90 following the single injection.
Completed Initial Public Offering. In May 2019, Bicycle completed its initial public offering (IPO) of 4,637,666 American Depositary Shares (ADSs), which included a partial exercise of the underwriters’ option to purchase additional ADSs, at $14.00 per ADS, for gross proceeds of $64.9 million, before deducting underwriting discounts, commissions and offering expenses.
Entered Collaboration with Dementia Discovery Fund. In May 2019, Bicycle announced its collaboration with the Dementia Discovery Fund (DDF), which allows the organization to use Bicycle technology for the development of novel therapeutics for neurodegenerative diseases. Under the terms of the agreement, Bicycle will identify Bicycles that bind to genetically-validated dementia targets. If promising lead compounds are identified, Bicycle will own the resulting IP and, with DDF, have the option to jointly establish a new company to develop those compounds.
Strengthened Clinical Team to Advance Expanding Pipeline. In May 2019, Bicycle announced two senior appointments to help expand the Company’s clinical pipeline. Lisa Mahnke, M.D., Ph.D., joined as Senior Vice President and Head of Clinical and Terrence West, MBA, joined as Vice President and Head of Program Management. Dr. Mahnke was recently VP, Head of Clinical Development at Syros Pharmaceuticals and previously served at EMD Serono. Mr. West was previously Executive Director, Project Management, at EMD Serono.
Financial Results

Cash and cash equivalents were $108.5 million as of June 30, 2019, compared with $63.4 million as of December 31, 2018. In the second quarter of 2019, Bicycle completed its IPO for gross proceeds of $64.9 million, before deducting underwriting discounts, commissions and offering expenses.
Collaboration revenues were $1.5 million for the three months ended June 30, 2019 compared to $1.7 million for the three months ended June 30, 2018. The change in revenue includes $1.1 million of revenue recognized from new collaboration activities in Q2 2019, offset by a decrease in Sanofi revenue.
Research and development expenses totaled $6.5 million for the three months ended June 30, 2019, compared to $4.9 million for the three months ended June 30, 2018. The increase of $1.6 million is primarily due to a $2.5 million increase in direct program related spending and personnel related expenses, offset by an increase in research and development tax credit reimbursement of $0.9 million.
General and administrative expenses were $3.0 million for the three months ended June 30, 2019, compared to $1.7 million for the three months ended June 30, 2018. The increase was largely due to increased personnel costs associated with the growth of the Company and professional fees related to operations as a public company.
Net loss was $10.2 million, or $(1.40) basic and diluted net loss per share, for the three months ended June 30, 2019, compared to net loss of $5.0 million, or $(11.85) basic diluted net income per share, for the three months ended June 30, 2018.

Exicure Reports Second Quarter 2019 Financial Results and Recent Developments

On August 8, 2019 Exicure, Inc. (Nasdaq: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported financial results for the second quarter ended June 30, 2019 and provided an update on corporate progress (Press release, Exicure, AUG 8, 2019, View Source [SID1234538454]).

"The first half of 2019 continued to bring advancements across our pipeline," said Dr. David Giljohann, Exicure’s chief executive officer. "We are extremely pleased with the strong progress in both our neurology and oncology franchises, while we simultaneously strengthened our board leadership and balance sheet. Our non-human primate data confirmed our enthusiasm for neurological applications of our SNA platform. Our recent $63.3 million public offering, which closed on August 2, 2019 provides the financial resources to advance these opportunities," he added.

Second Quarter Corporate Progress and Recent Developments

Announced important preclinical data supporting development of SNA technology in the central nervous system (CNS)
Presented results from a biodistribution study of SNAs in the CNS of non-human primates.
SNAs were observed in all 46 regions of the brain examined.
Preclinical research underway in indications including Huntington’s disease, spinocerebellar ataxia type 3 (SCA3), SCA2, SCA1, Friedreich’s ataxia and Batten disease.
Expect to nominate first candidate for neurological conditions late in 2019.
Expanded Board with experienced biotechnology leaders
Jeffrey L. Cleland, Bosan Hau, Bali Muralidhar and Timothy Walbert.
AST-008 Phase 1b/2 clinical trial continues to progress—AST-008 is an SNA consisting of toll-like receptor 9 agonists designed for immuno-oncology applications.
Company expects to complete Phase 1b enrollment of this trial by late 2019.
Enhanced Financial Resources
Closed oversubscribed underwritten public offering of 31,625,000 shares of common stock at $2.00 per share for gross proceeds of $63.3 million with net proceeds of approximately of $58.8 million after deducting underwriters’ discounts and commissions and estimated offering expenses.
Insider participation of approximately $2.6 million from David Walt, Jay Ventakensan and Chad Mirkin.
Up-listed from the OTC to the Nasdaq Capital Market.
Second Quarter 2019 Financial Results and Financial Guidance

Cash Position: As of June 30, 2019, Exicure had cash and cash equivalents of $17.2 million compared to $26.3 million as of December 31, 2018.

Research and Development (R&D) Expenses: Research and development expenses were $3.4 million for the quarter ended June 30, 2019, compared to $3.8 million for the quarter ended June 30, 2018. The decrease in research and development expenses of $0.4 million was primarily due to lower clinical development programs expense of $0.6 million, partially offset by higher platform and discovery-related expenses of $0.1 million.

General and Administrative (G&A) Expenses: General and administrative expenses were $2.0 million for the quarter ended June 30, 2019, compared to $2.0 million for the quarter ended June 30, 2018. Higher costs for compensation, travel, stock-based compensation and lease expenses were offset by lower legal fees.

Net Loss: Net loss was $5.2 million for the quarter ended June 30, 2019, compared to net loss of $6.8 million for the quarter ended June 30, 2018. The $1.6 million reduction in net loss was due to the addition of $0.4 million of revenue associated with the Dermelix transaction, the $0.4 million reduction in R&D expenses described above and the $0.8 million reduction in loss in Other income attributable to the (non-cash) fair value adjustment of our common stock warrant liability.

Cash Runway Guidance: Exicure believes that, based on its current operating plans and estimates of expenses, as of the date of this press release, its existing cash and cash equivalents will be sufficient to meet its anticipated cash requirements in excess of twelve months.