On May 9, 2018 MannKind Corporation(NASDAQ:MNKD) reported financial results for the first quarter ended March 31, 2018 (Press release, Mannkind, MAY 9, 2018, View Source [SID1234526376]).

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"We started 2018 with solid growth of 184% in quarterly Afrezza sales year-over-year, which reflects our progression as a fully-integrated commercial enterprise and our focused promotional efforts," said Michael Castagna, Chief Executive Officer of MannKind Corporation. "We look forward to new scientific data releases at the American Diabetes Association scientific meeting in June to help clinicians better understand the unique benefits of this innovative product."

For the first quarter of 2018, Afrezza net revenue was $3.4 million compared to $1.2 million for the first quarter of 2017, an increase of $2.2 million or 184%. On January 1, 2018, the Company adopted ASC 606, the new revenue recognition standard, under which it recognizes revenue as it sells product to wholesale distributors. Previously, it recognized sales on the basis of a model that estimated the sale of Afrezza to patients. As of January 1 2018, it reduced $3.4 million in previously deferred revenue (that reflected inventory in sales channels) to zero and also made a corresponding decrease to accumulated deficit. A comparison of the condensed consolidated financial statements with and without the adoption of ASC 606 can be found in the Notes to Condensed Consolidated Financial Statements in the form 10-Q for the quarter ended March 31, 2018. Total revenue for the first quarter of 2018 was $3.4 million compared to $3.0 million for the first quarter of 2017, an increase of $0.4 million or 15%. This increase was primarily due to the increased net revenue from Afrezza, partially offset by the sale of bulk insulin of $1.7 million in the first quarter of 2017.

Cost of goods sold for the first quarter of 2018 was $4.0 million compared to $2.5 million for the first quarter of 2017, an increase $1.5 million or 57%. This increase was primarily the result of higher Afrezza sales compared to the same period in the prior year together with inventory write-offs of $0.6 million in the quarter ended March 31, 2018. There were no inventory write-offs in the same period of the prior year.

Research and development (R&D) expenses for the first quarter of 2018 were $2.6 million compared to $3.1 million for the first quarter of 2017, a decrease of $0.5 million or 16%. This decrease reflected a $1.1 million reallocation of salary and salary-related expenses from R&D in 2017 to selling, general and administrative expenses (SG&A) in 2018) associated with personnel who were engaged in R&D activities in 2017 and transitioned to providing medical affairs and pharmacovigilance support to Afrezza commercial activities in 2018. The decrease in R&D expenses in the first quart of 2018 was offset by increased outside contract research organization spending on clinical trials of $0.5 million.

SG&A expenses were $20.6 million for the first quarter of 2018 compared to $15.4 million for the first quarter of 2017. The $5.2 million or 34% increase was primarily due to $5.7 million in headcount-related expenses from additional field force and G&A support functions (inclusive of the $1.1 million reallocation from R&D). In addition, there was a charge of $0.8 million in the first quarter 2018 for costs related to transitioning corporate support functions from Danbury, CT to Westlake Village, CA to create a more efficient back-office operation. Partially offsetting these increases were a $0.5 million decrease in spending on outside sales efforts that were transitioned in-house, $0.6 million lower consulting costs, and $0.2 million due to lower facility costs.

The net loss for the first quarter of 2018 was $30.4 million, or $0.25 per share compared to a $16.3 million net loss in the first quarter of 2017 or $0.17 per share. In addition to the variances described above which impacted the net loss in 2017, there was a favorable change due to a non-cash gain recognized in the first quarter of 2017 for the decrease in the fair value of warrant liability of $6.6 million which did not have a corresponding first quarter 2018 amount as the warrants were exchanged for shares and cancelled in October 2017.

Cash, cash equivalents and restricted cash at March 31, 2018 decreased to $27.2 million compared to $48.4 million at December 31, 2017, primarily due to net cash used in operating activities of $21.7 million in the first quarter 2018 offset by $0.5 million of net proceeds from the at-the-market equity offering facility. Subsequent to the quarter end in early April, the Company raised $26.3 million of net proceeds from a registered direct offering of 14 million shares of common stock and warrants at a purchase price of $2.00 per share and accompanying warrant exercisable at $2.38 per share.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. To participate in the live call by telephone, please dial (800) 289-0438 toll-free or (323)794-2423 toll/international and use the conference passcode: 3321662. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at www.mannkindcorp.com.

A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 toll free or (412) 317-6671 toll/international and use the replay passcode: 3321662. A replay will also be available on MannKind’s website for 14 days.

On May 9, 2018 SELLAS Life Sciences Group Inc. (Nasdaq:SLS) ("SELLAS"), a clinical-stage biopharmaceutical company focused on novel cancer immunotherapies for a broad range of cancer indications, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its novel drug candidate, galinpepimut-S (GPS), for the treatment of multiple myeloma (MM) (Press release, Sellas Life Sciences, MAY 9, 2018, View Source [SID1234526392]). GPS is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms Tumor 1 (WT1) protein, which is present in an array of tumor types.

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"We are delighted to receive this orphan drug designation as it underscores the great need for innovative, effective treatments for this rare cancer, and recognizes the potential benefits that GPS may provide for patients with MM," said Angelos Stergiou, MD, ScD h.c., President & Chief Executive Officer of SELLAS. "Receiving orphan drug designation for the treatment of MM is a significant regulatory milestone in the development of GPS. We have reported median progression-free survival (PFS) of 23.6 months in the high-risk MM disease setting, compared to historically inferior outcomes in such a patient cohort of around 12 months, and GPS stimulated time-dependent and robust CD4+ T cell or CD8+ T cell immune responses as well as multifunctional cross-epitope T cell reactivity."

GPS has also received orphan drug designation for the treatment of acute myeloid leukemia (AML) and malignant plural mesothelioma (MPM). SELLAS has Phase 3 clinical trials planned for GPS in both AML and MPM and is developing GPS as a potential treatment for a broad range of other cancer indications, including multiple myeloma.

The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. Orphan drug designation may provide certain benefits, including a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.

On May 9, 2018 Novavax, Inc., (Nasdaq: NVAX) reported its financial results for the first quarter ended March 31, 2018 (Press release, Novavax, MAY 9, 2018, View Source [SID1234526488]).

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First Quarter and Subsequent Achievements:

RSV F Vaccine

In May 2018, Novavax reached enrollment of approximately 4,600 pregnant women in its Prepare Phase 3 clinical trial of its RSV F Vaccine for infants via maternal immunization. This milestone enables Novavax to initiate a prespecified interim efficacy analysis after approximately six months of follow-up of the last infant born to the approximately 4,600 women enrolled (including 3,000 actively vaccinated women). Completion of this analysis is expected in the first quarter of 2019. Since 2015, the Prepare trial is supported by an $89 million grant from the Bill & Melinda Gates Foundation (BMGF).

In April 2018, Novavax presented at the World Vaccine Congress on the status of its Phase 3 clinical trial of its RSV F Vaccine.

NanoFlu

In April 2018, Novavax presented clinical data at the World Vaccine Congress from the Phase 1/2 clinical trial in older adults comparing trivalent formulations of NanoFlu to the market-leading licensed egg-based, high-dose influenza vaccine for older adults.

In February 2018, Novavax reported positive top-line results from its Phase 1/2 clinical trial of its trivalent NanoFlu.

Corporate

In April 2018, Novavax completed an underwritten public offering of approximately 34.8 million shares of its common stock, including 4.5 million shares pursuant to the underwriters’ option to purchase additional shares. The shares resulted in net proceeds of $54 million.

Effective on March 14, 2018, John J. Trizzino, former Senior Vice President, Commercial Operations since 2014, was promoted to Senior Vice President, Chief Business Officer and Chief Financial Officer.

Anticipated Events:

Initiation of the Phase 2 clinical trial of quadrivalent formulations of NanoFlu scheduled to begin in the third quarter of 2018.

·Top-line data from the Phase 2 NanoFlu trial and End of Phase 2 meeting with the FDA expected in the first quarter of 2019.

Results of the Prepare Phase 3 interim efficacy analysis for our RSV F Vaccine expected in the first quarter of 2019.

Summary

"We had an extremely productive first quarter, including making important advances in our two lead clinical vaccine programs. We are pleased to have reached the enrollment target for our Prepare Phase 3 RSV F Vaccine trial, which clears the path for following these most recent participants and their babies, and subsequently announcing top-line results of our planned interim efficacy analysis in the first quarter of 2019," said Stanley C. Erck, President and CEO of Novavax, Inc. "We also continue to make significant progress on NanoFlu and plan to initiate a Phase 2 clinical trial in the third quarter of 2018."

Financial Results for the First Quarter Ended March 31, 2018

Novavax reported a net loss of $46.4 million, or $0.14 per share, for the first quarter of 2018, compared to a net loss of $43.9 million, or $0.16 per share, for the first quarter of 2017.

Novavax revenue in the first quarter of 2018 was $9.7 million, compared to $5.7 million in the same period in 2017. This 70% increase was driven by higher revenue recorded under the BMGF grant corresponding to the increased enrollment in the Prepare trial.

Research and development expenses increased 18% to $44.5 million in the first quarter of 2018, compared to $37.7 million for the same period in 2017. The increase was primarily due to increased development activities of the RSV F Vaccine for infants via maternal immunization.

Interest income (expense), net for the first quarter of 2018 was ($2.9) million, compared to ($3.0) million for the same period of 2017.

As of March 31, 2018, Novavax had $164.2 million in cash, cash equivalents, marketable securities and restricted cash, compared to $186.4 million as of December 31, 2017. Net cash used in operating activities for the first quarter of 2018 was $66.1 million, compared to $44.5 million for same period in 2017. The increase in cash usage was primarily due to approximately $16 million of one-time payments, as well as the adoption of a new accounting standard that requires restricted cash to be included in the beginning and ending balances on the statements of cash flows, thus increasing Novavax’ cash usage in the first quarter of 2018 and 2017 by approximately $9 million and $6 million, respectively. We expect our cash used in operating activities to significantly decrease for the subsequent quarters of 2018 as compared to the first quarter of 2018.

Conference Call

Novavax management will host its quarterly conference call today at 4:30 p.m. ET. The dial-in number for the conference call is (877) 212-6076 (Domestic) or (707) 287-9331 (International), passcode 3687883. A replay of the conference call will be available starting at 7:30 p.m. ET on May 9, 2018 until 7:30 p.m. ET on May 16, 2018. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 3687883.

A webcast of the conference call can also be accessed via a link on the home page of the Novavax website at www.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 August 9, 2018.

About RSV

RSV is the most common cause of lower respiratory tract infections and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide, with estimated annual infection and mortality rates of 64 million and 160,000, respectively.1 In the U.S., RSV is the leading cause of hospitalization of infants.2 Despite the induction of post-infection immunity, repeat infection and lifelong susceptibility to RSV is common.3 Currently, there is no approved RSV vaccine available.

About RSV F Vaccine for Infants via Maternal Immunization

Novavax is developing a vaccine that targets the fusion protein, or F protein, of the RSV virus. The F protein has highly conserved amino acid sequences, called antigenic sites, which are the target of neutralizing antibodies and are believed to be ideal vaccine targets. Novavax’ genetically engineered novel F protein antigen exposes a range of these antigenic sites, and can evoke immune responses to them in human vaccine recipients. In a previous Phase 2 clinical trial of the RSV F Vaccine, which assessed the transplacental transfer of maternal antibodies induced by the vaccine, immunized women demonstrated meaningful fold rises in anti-F IgG, palivizumab-competing antibodies and microneutralization titers. In addition, infants’ antibody levels at delivery averaged 90-100% of the mothers’ levels, indicating efficient transplacental transfer of antibodies from mother to infant.

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 each year are attributed to influenza.4 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 2025.5

1 View Source

2 Leader S. Pediatr Infect Dis J. 2002 Jul;21(7):629-32

3 PLOS. "How immunity to respiratory syncytial virus develops in childhood, deteriorates in adults." ScienceDaily. 21 April 2016. View Source

4 Resolution of the World Health Assembly (2003) WHA56.19.28

5 Influenza Vaccines Forecasts. Datamonitor (2013)

About NanoFlu

NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine candidate 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.

On May 9, 2018 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported financial results for the first quarter ended March 31, 2018 (Press release, Compugen, MAY 9, 2018, View Source [SID1234526305]).

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"Key developments in the first quarter of 2018 support Compugen’s position as a leader in predictive discovery of new drug targets, and as an emerging clinical-stage immuno-oncology therapeutics company," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "In late March, we filed an IND application for COM701, our leading first-in-class immuno-oncology therapeutic program targeting PVRIG. The FDA informed us that the IND application review can be completed once we provide additional information regarding COM701’s assay method at a lower recommended starting dose. We have already initiated activities to provide the information to the Agency, and do not anticipate that this will impact our timelines and overall clinical plans."

"Preclinical data suggest that our PVRIG inhibitor may trigger an anti-tumor immune response alone and in combination with TIGIT and/or PD-1 inhibitors in many cancers. As COM701 is the first clinical antibody candidate targeting PVRIG to be available for testing dual and triple combinations with TIGIT and PD-1 inhibitors, we believe it places Compugen in a unique position and gives us a competitive edge in the immuno-oncology space."

"In the first quarter of the year, we also entered into a license agreement with MedImmune, the global biologics research and development arm of AstraZeneca. With this agreement we monetized one of our pipeline assets, in applications where we do not have existing development plans, to provide capital to support our ongoing development programs."

"In light of Bayer’s announcement that they plan to begin first-in-human trials for their ILDR2 antibody, we expect that two first-in-class immuno-oncology programs based on our discoveries will be in the clinic in 2018. Advancing a program from computer prediction to IND filing is a tremendous achievement, and we are excited about the potential for these programs to provide meaningful benefit to cancer patients in need," concluded Dr. Cohen-Dayag.

Recent highlights:
·
Submitted IND application for COM701, a novel first-in-class therapeutic antibody targeting PVRIG.
·
Bayer presented preclinical data on BAY 1905254, its therapeutic antibody targeting ILDR2, at the annual meeting of the American Association of Cancer Research held in April 2018 and announced its plans to advance the program to clinical trial in 2018.
·
Entered into a license agreement with MedImmune, the global biologics research and development arm of AstraZeneca, to enable the development of bi-specific and multi-specific immuno-oncology antibody products based on one of Compugen’s pipeline programs.

Financial Results

Revenues for the first quarter of 2018 were $10 million, compared with $0 in the comparable period of 2017. The revenues for the quarter reflect the upfront payment of $10 million from the license agreement with MedImmune.

R&D expenses for the first quarter ended March 31, 2018, were $7.1 million, compared with $6.7 million for the comparable period in 2017. The increase in R&D expenses continues to reflect preclinical development activities, including those supporting the IND filing for COM701, as well as expenses associated with clinical-related activities in preparation for the Phase 1 trial expected to begin later in 2018.

Net income for the first quarter of 2018 was $0.1 million, or $0 per diluted share, compared with a net loss of $8.7 million, or $0.17 per diluted share, in the comparable period of 2017.

As of March 31, 2018, cash, cash related accounts, short-term and long-term bank deposits totaled $20.5 million, not including the $10 million payment from MedImmune received after the quarter end, compared with $30.4 million at December 31, 2017. The Company has no debt.

Conference Call and Webcast Information

Compugen will hold a conference call to discuss its first quarter 2018 results today, May 9, 2018, at 10:00 a.m. ET. To access the live conference call by telephone, please dial 1-888-407-2553 from the U.S., or +972-3-918-0610 internationally. The conference call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website (www.cgen.com).

On May 9, 2018 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that it will host a live conference call and audio webcast on Wednesday, May 16, 2018 at 8:30 a.m. ET to report financial results for the first quarter ended March 31, 2018 and to provide a business overview (Press release, Bio-Path Holdings, MAY 9, 2018, View Source [SID1234526361]).

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To access the live conference call, please call (844) 815-4963 (domestic) or (210) 229-8838 (international) at least five minutes prior to the start time and refer to conference ID 1096178. A live audio webcast of the call will also be available on the Presentations section of the Company’s website, www.biopathholdings.com. An archived webcast will be available on the Bio-Path website approximately two hours after the event.