On August 1, 2018 Immune Design (Nasdaq: IMDZ), an immunotherapy company focused on next-generation therapies in oncology, reported financial results and a corporate update for the second quarter ended June 30, 2018 (Press release, Immune Design, AUG 1, 2018, View Source [SID1234528291]).

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"We have had a solid year of progress so far at Immune Design, with important advancements with CMB305, and now with G100," said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer of Immune Design. "Based on recent interactions with the FDA, we plan to aggressively advance G100 in follicular lymphoma patients. Simultaneously, the CMB305 pivotal Phase 3 SYNOVATE trial is now open for enrollment in the U.S. to patients with synovial sarcoma. We believe these late-stage programs position us well to bring novel therapies to cancer patients with high unmet need."

Pipeline Highlights

G100: moving forward with an ORR-based study in patients with relapsed follicular lymphoma (FL)

G100 is a novel, synthetic TLR4 agonist for intratumoral therapy
Based on feedback from an End of Phase 1 FDA meeting:
FDA notes that relapsed FL patients who have failed three lines of systemic therapy represents an unmet medical need population; and
FDA agrees that a single-arm trial to evaluate objective response rate (ORR) and duration of response (DOR) is appropriate to assess the efficacy of G100 in combination with pembrolizumab with an adaptive design that allows for an interim analysis. Immune Design is working with the FDA on the details of the study and plans to initiate patient enrollment as soon as feasible after the protocol is finalized.
The company intends to use this open label approach to generate data for a potential biological license application and plans to provide an update on the final study design and associated timeline after the ongoing FDA discussions are complete.
CMB305: the SYNOVATE Phase 3 trial is open for enrollment; combination with atezolizumab Phase 2 ongoing
CMB305 is a novel prime-boost cancer vaccine targeting NY-ESO-1+ cancers in patients with soft tissue sarcoma.
Monotherapy:
SYNOVATE study, a randomized, global Phase 3 trial evaluating CMB305 monotherapy versus placebo in synovial sarcoma patients in a post 1st line therapy maintenance setting is open for enrollment.
Immune Design is working on opening additional clinical sites throughout the United States, followed by expansion into Canada, Europe and the Asia Pacific region.
Combination therapy: the Phase 2 study evaluating the combination of CMB305 with atezolizumab in relapsed refractory soft-tissue sarcoma patients continues follow-up to determine overall survival after achieving an estimated 72 events.
Research Programs
Immune Design will shift resources to focus on later-stage programs, specifically for the development of G100 in relapsed FL and beyond. Consequently, the company is pausing further development of its preclinical programs, CA21 and intratumoral ZVex-IL12.
This allocation of resources enables the company to run the planned G100 study at least to the interim analysis with existing capital.
Upcoming Data Presentation
Immune Design plans to present long-term follow-up data from its CMB305 monotherapy trial in soft tissue sarcoma patients at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress in October. The ESMO (Free ESMO Whitepaper) presentation will be in the forms of both a poster and poster discussion session.
Financial Results

Immune Design ended the second quarter of 2018 with $120.3 million in cash and cash equivalents, short-term investments, and other receivables compared to $144.2 million as of December 31, 2017. Net cash used in operations for the six months ended June 30, 2018 was $27.3 million.
Net loss and net loss per share for the second quarter of 2018 were $13.8 million and $0.29, respectively, compared to $13.8 million and $0.54, respectively, for the second quarter of 2017.
Revenue for the second quarter of 2018 was $0.8 million and was primarily attributable to $0.4 million in collaboration revenue associated with the Sanofi G103 HSV2 vaccine collaboration and $0.4 million in product sales to collaboration partners. Revenue for the second quarter of 2017 was $0.7 million and was primarily attributable to collaboration revenue associated with the Sanofi G103 collaboration.
Research and development expenses for the second quarter of 2018 were $11.0 million, compared to $10.9 million for the same period in 2017. The $0.1 million increase in research and development expenses was primarily attributable to an increase in personnel-related expenses and an increase in research and development headcount to support the company’s advancing research and clinical pipeline activities. This increase was offset by a slight decrease of $0.1 million in in-licensing royalties and fees and a $0.1 million decrease in research and development supplies and services.
General and administrative expenses for the second quarter of 2018 were $4.0 million, compared to $3.9 million for the same period in 2017. The $0.1 million increase in general and administrative expenses was primarily attributable to an increase in professional fees and services to help support our ongoing operations, which was offset by a decrease in personnel-related expenses in the form of stock-based compensation expense.
Year-to-Date

Net loss and net loss per share for the six months ended June 30, 2018 were $27.1 million and $0.56, respectively, compared to $26.5 million and $1.04, respectively, for the same period in 2017.
Revenue for the six months ended June 30, 2018 was $1.3 million and was primarily attributable to $0.8 million in collaboration revenue associated with the Sanofi G103 collaboration and $0.4 million in product sales to collaboration partners. Revenue for the same period in 2017 was $6.2 million and was primarily attributable to $5.9 million in collaboration revenue associated with the Sanofi G103 collaboration and $0.3 million in product sales to other third parties.
Research and development expenses for the six months ended June 30, 2018 were $21.3 million compared to $24.9 million for the same period in 2017. The $3.6 million decrease in research and development expenses was primarily attributable to a decrease of $4.8 million in costs related to the timing and nature of certain contract manufacturing activities connected to the Sanofi G103 collaboration. Offsetting this decrease was an increase of $1.1 million in personnel-related expenses, which was primarily due to an increase in compensation and benefits and an increase in research and development headcount.
General and administrative expenses did not materially differ over the comparative periods. For the six months ended June 30, 2018, general and administrative expenses were $8.0 million compared to $8.0 million for the same period in 2017. In February 2018, Immune Design recouped $0.8 million from the TVS settlement, which decrease in expense was offset by an increase of $0.6 million in professional fees and services and $0.2 million in compensation and benefits to support ongoing operations.
Cash Guidance

Based on current expectations, Immune Design expects to have cash to fund operations into the second half of 2020.

Conference Call Information

Immune Design will host a conference call and live audio webcast this afternoon at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time to discuss second quarter 2018 financial results and provide a corporate update.

The live call may be accessed by dialing 844-266-9538 for domestic callers and 216-562-0391 for international callers. A live webcast of the call will be available online from the investor relations section of the Immune Design website at View Source and will be archived there for 30 days. A telephone replay of the call will be available for five days by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference code 3376676.

An archived copy of the webcast will be available on Immune Design’s website beginning approximately two hours after the conference call. Immune Design will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.

On August 1, 2018 FibroGen, Inc. (NASDAQ: FGEN), a biopharmaceutical company, reported that it will report second quarter 2018 financial results on Tuesday, August 7, 2018, after market close, and will host a conference call to discuss financial results and provide a business update at 5:00 p.m. ET (2:00 p.m. PT) (Press release, FibroGen, AUG 1, 2018, View Source;p=irol-newsArticle&ID=2361527 [SID1234528292]).

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Conference Call and Audio Webcast
Interested parties may access a live audio webcast of the conference call via the investor section of the FibroGen website, www.fibrogen.com. It is recommended that listeners access the website 15 minutes prior to the start of the call to download and install any necessary audio software. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (888) 843-7419 (domestic) or (630) 652-3042 (international), and use passcode 47339190#.

Dial-In Information
Live (U.S./Canada): (888) 771-4371
Live (International): (847) 585-4405
Confirmation number: 47339190

On August 1, 2018 The Medicines Company (NASDAQ:MDCO) reported its financial results for the second quarter ended June 30, 2018 (Press release, Medicines Company, AUG 1, 2018, View Source;p=RssLanding&cat=news&id=2361238 [SID1234528394]).

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"During the second quarter of 2018, we continued to advance inclisiran’s development programs, including the accumulation of further promising safety data from 3,660 patients in Phase III trials," said Clive Meanwell, M.D., Ph.D., Chief Executive Officer of The Medicines Company. "We were also able to present consistent phase II subset efficacy data in various demographic and disease populations for LDL-C and other atherogenic lipoproteins. We look forward to further progress in 2018 and Phase III data read-outs in 2019."

Second quarter 2018 highlights included the following:

In April, the Company presented new data and analyses from multiple studies in the ORION development program for inclisiran at the National Lipid Association 2018 Scientific Sessions. The data demonstrated that inclisiran likely has a "one-size-fits-all" dosing regimen, without the necessity of dose adjustments, across a wide range of dyslipidemia patient populations, including those hard-to-treat patients with homozygous familial hypercholesterolemia (HoFH) and other sub-groups, such as patients with renal impairment and diabetes. The data showed that inclisiran lowered low-density lipoproteins cholesterol (LDL-C) by more than 50% for a wide range of dyslipidemia patient populations and sub-groups, and by up to 44% in HoFH patients.
In May, the Company presented the results of a pre-specified analysis of secondary endpoints from the ORION-1 Phase II trial at the 86thEuropean Atherosclerosis Society Congress. The results, which were published in Circulation, the journal of the American Heart Association, showed that, beyond its powerful effect on LDL-C, inclisiran also reduced atherogenic lipoproteins in a profound and sustained manner. Atherogenic lipoproteins – non-HDL-C, ApoB, VLDL-C and Lp(a) – have been associated with an increased risk of heart attacks and strokes, particularly in high-risk patients. The reductions, which were generally dose-dependent, were achieved most clearly with a 300 mg dose of inclisiran given on Day-1 and Day-90, and were sustained to the pre-specified time of assessment (180 days) and beyond (at least 210 days). This is the same starting dose of inclisiran being utilized in the Phase III trials (the Phase III dose of inclisiran is 300 mg given on Day-1 and Day-90, and then every six months thereafter).
In June, the Company presented new data from a pre-specified, subgroup analysis of dosing, efficacy and safety of inclisiran in patients with diabetes from the ORION-1 Phase II trial at the American Diabetes Association 78th Scientific Sessions. The data demonstrated that a subcutaneous injection of 300 mg of inclisiran given at Day-1 and Day-90 lowered LDL-C at Day-180 by more than 50% in patients with atherosclerotic cardiovascular disease (ASCVD) and those considered ASCVD-risk equivalents, regardless of whether those patients had diabetes. Importantly, the data showed that patients with and without diabetes experienced similar adverse event profiles, including no effects on control of blood glucose levels over six months.
In June, the Independent Data Monitoring Committee (IDMC) for the ongoing inclisiran Phase III clinical trials conducted its third, planned review of safety and efficacy data from the trials and recommended that they continue without modification. At the time of the review, substantially all patients in trials had received two doses of inclisiran or placebo, and more than 1,550 patient-years of safety data for inclisiran had been accumulated – with an additional 5 patient-years of safety data continuing to accumulate every day.
During the second quarter, the Company substantially completed the implementation of its previously-announced restructuring, as anticipated.
Commenting further, Dr. Meanwell said, "We continued to deliver against our 2018 objectives during the second quarter, demonstrating strong execution on all fronts. We remain sharply focused on tightening expense management and advancing the inclisiran development program efficiently."

Second-Quarter 2018 Financial Summary from Continuing Operations

On a GAAP basis, loss from continuing operations in the second quarter of 2018 was $54.5 million, or $0.74 per share, compared to a loss of $370.1 million, or $5.15 per share, in the second quarter of 2017. Included in loss from continuing operations for the second quarter of 2018 were restructuring charges of $6.1 million. On a non-GAAP basis, adjusted loss(1) from continuing operations in the second quarter of 2018 was $46.3 million, or $0.63(1) per share, compared to a loss of $52.0 million, or $0.72(1) per share, in the second quarter of 2017.

First Half 2018 Financial Summary from Continuing Operations

On a GAAP basis, loss from continuing operations in the first half of 2018 was $139.3 million, or $1.89 per share, compared to a loss of $441.1 million, or $6.17 per share, in the first half of 2017. Included in loss from continuing operations for the first half of 2018 was a non-cash, mark-to-market change in fair value of approximately $31.1 million associated with the Company’s common stock ownership in Melinta, guaranteed repayments and restructuring charges of $11.4 million. On a non-GAAP basis, adjusted loss(1) from continuing operations in the first half of 2018 was $102.6 million, or $1.40(1) per share, compared to a loss of $105.3 million, or $1.47(1) per share, in the first half of 2017.

First Half 2018 Financial Summary from Discontinued Operations

In the first quarter of 2018, the Company completed the sale of its infectious disease business, consisting of the products Vabomere, Orbactiv and Minocin IV, as well as line extensions of those products, for $270 million in upfront consideration and guaranteed payments, tiered royalty payments of between 5% to 25% on worldwide net sales of Vabomere, Orbactiv and Minocin IV, and the assumption by Melinta of all royalty, milestone and other payment obligations relating to those products.

(1) Adjusted net loss and adjusted loss per share from continuing operations are non-GAAP financial performance measures with no standardized definitions under U.S. GAAP. For further information and a detailed reconciliation, refer to the "Non-GAAP Financial Performance Measures" and "Reconciliations of GAAP to Adjusted Loss From Continuing Operations and Adjusted Loss per Share" sections of this press release.

Net income from discontinued operations in the first half of 2018 was $114.2 million, compared to a net loss of $58.9 million in 2017. Net income from discontinued operations in the first half of 2018 included a pre-tax gain of approximately $169.0 million from the sale of the Company’s infectious disease business to Melinta.

At June 30, 2018, the Company had $162.5 million in cash and cash equivalents, compared to $151.4 million at the end of 2017.

Second-Quarter 2018 Conference Call and Webcast Information

The Company will host a conference call and webcast today, August 1, 2018, at 8:30 a.m., Eastern Daylight Time, to discuss its second-quarter 2018 financial results and provide clinical and operational updates. The dial-in information to access the call is as follows:

U.S./Canada: (877) 359-9508
International: (224) 357-2393
Conference ID: 5847059
A taped replay of the conference call will be available from 11:30 a.m., Eastern Daylight Time, today until 11:30 p.m., Eastern Daylight Time, on August 8, 2018. The replay may be accessed as follows:

U.S./Canada: (855) 859-2056
International: (404) 537-3406
Conference ID: 5847059
The webcast can be accessed in the "Investors" section of The Medicines Company website. A replay of the webcast will also be available.

About Inclisiran

Inclisiran is an investigational GalNAc-conjugated RNA interference therapeutic, which inhibits the synthesis of PCSK9 protein in liver cells, thereby reducing liver cell LDL receptor turnover, and lowering plasma LDL-C.

The Medicines Company and Alnylam Pharmaceuticals, Inc. are collaborating in the advancement of inclisiran pursuant to their 2013 agreement. Under the terms of the agreement, Alnylam completed certain pre-clinical studies and the Phase I clinical study, with The Medicines Company leading and funding the development of inclisiran from Phase II forward, as well as potential commercialization.

On August 1, 2018 PepVax, Inc., an early-stage biotechnology company, reported the launch of its novel SMARTmid platform for drug delivery of nucleic acid and amino acid-based drugs and cell therapies in pre-clinical development (Press release, PepVax, AUG 1, 2018, View Source [SID1234630790]). With manufacturing and delivery of immunotherapies, cell therapies, and gene therapies getting increasingly complicated and expensive at scale-up, the SMARTmid platform offers a unique solution with our "Trojan Horse" approach to use the patient’s own cells to manufacture the required proteins, T-cells and nucleic acids in vivo for cancers, infectious and genetic diseases.

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Learn more about PepVax here – View Source

The Perfect Solution for Researchers and Early-Stage Biotechnology Companies

Our SMARTmid vector design is our fully synthetic method for producing plasmid vector particles for mammalian cell transduction and is a powerful template in which to build a drug delivery and immuno-adjuvant platform. DNA-based delivery can directly enhance expression levels and enable easy manufacturing of protein-, DNA- and RNA-based treatments in vivo. Moreover, SMARTmid can be used as an immuno-adjuvant to enhance already developed drugs to work more effectively in patients requiring a strong immune response, like checkpoint inhibitors and CAR-T treatments. SMARTmid can also be used as a diagnostic tool for certain cancers and infectious diseases.

Efficiency and Simplicity That Just Works
"Delivering drugs has always been a challenge for drug developers," said Mahesh Narayanan, CEO of PepVax. "Researchers and research companies looking to deliver their biologics intramuscularly or intravenously can use our SMARTmid platform to produce their drugs inside the patient or deliver it without worrying about degeneration or decreased potency."

Focused on Continued Innovation
PepVax is looking to license SMARTmid to established biopharmaceutical companies that are looking for efficient drug delivery in patients as well as developing novel cancer and infectious disease therapeutics. The Company is also looking to enter into research agreements with academia.

On August 1, 2018 Nektar Therapeutics (Nasdaq: NKTR) reported that it will announce its financial results for the second quarter on Wednesday, August 8, 2018, after the close of U.S.-based financial markets (Press release, Nektar Therapeutics, AUG 1, 2018, View Source [SID1234528277]). Howard Robin, president and chief executive officer, will host a conference call to review the results beginning at 5:00 p.m. Eastern Time (ET)/2:00 p.m. Pacific Time (PT).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through Monday, September 10, 2018.

To access the conference call, follow these instructions:

Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)
Passcode: 7099844 (Nektar Therapeutics is the host)