On August 7, 2018 Synlogic(Nasdaq:SYBX) reported that Aoife Brennan, M.B., B.Ch., Synlogic’s interim president and chief executive officer, and chief medical officer, will present a corporate update at the 2018 Wedbush PacGrow Healthcare Conference at 3:05pm ET on Tuesday, August 14, 2018, in New York City (Press release, Synlogic, AUG 7, 2018, View Source [SID1234528792]).

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A live webcast of the presentation can be accessed under "Event Calendar" in the Investors & Media section of the Company’s website. An archived webcast recording will be available on the Synlogic website for approximately 30 days after the event.

On August 7, 2018 Sesen Bio, Inc. (Nasdaq: SESN), a late-stage clinical company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of cancer, reported key leadership transitions as part of its evolution into a commercial-stage oncology company (Press release, Eleven Biotherapeutics, AUG 7, 2018, View Source [SID1234528926]). Thomas Cannell, DVM has been appointed chief executive officer and a member of the board of directors, bringing with him a wealth of leadership experience in building and overseeing strategic operations and global pharmaceutical commercialization for life science companies. Stephen Hurly left his employment with Sesen Bio effective August 7, 2018.

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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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"Over the last two years, Sesen Bio has undergone a unique evolution as a company. Following the acquisition of Viventia and the resulting transition from an ophthalmology organization to an oncology company, we have been wholly focused on developing Vicinium for high-grade non-muscle invasive bladder cancer," said Wendy Dixon, Ph.D., chair of Sesen Bio’s board of directors. "We are grateful to Steve for his many significant contributions in advancing Sesen Bio to where it is today, and we wish him all the best in his future endeavors. As we transition further as a company, Tom will be an exceptional strategic leader bringing deep experience in drug development and commercialization to drive Vicinium, our pipeline and the company through this important next chapter."
Thomas Cannell most recently served as chief operating officer and president of global commercial products at Orexigen Therapeutics, Inc., where he led the successful commercialization and profitability of Contrave. Prior to Orexigen, Dr. Cannell spent 27 years with Merck & Co., Inc., where he held senior leadership positions in global commercialization, consumer marketing, and sales operations and management for both development-stage programs and approved marketed products. While with Merck, he served as president of Merck Canada and head of marketing and strategy for Merck Sharp & Dohme Corp., Japan, a subsidiary of Merck & Co., where he was responsible for setting up a long-standing strategic process and plan, managed a multi-billion-dollar product portfolio and oversaw thousands of employees. In addition, he designed and successfully piloted an innovative, customer-centric commercial model for Merck’s U.S. business. Dr. Cannell received his DVM degree from Washington State University.
"My enthusiasm for joining Sesen Bio is based on the novel mechanism of Vicinium, its potential as a monotherapy and combination agent, particularly with checkpoint inhibitors, and

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the range of therapeutic opportunities with our novel fusion proteins," stated Dr. Cannell. "Over the next several months, we will be focused on several strategic objectives across our pipeline. These include: completing the Phase 3 registration trial for Vicinium with 12-month data expected by mid-2019; engaging with regulatory authorities to prepare for our first BLA submission; initiating the appropriate pre-commercial activities to support a potential future product approval and launch; and exploring new therapeutic opportunities in additional indications. I am excited to join the company at this pivotal time and believe strongly in our ability to execute these strategic priorities to make a meaningful difference in the lives of patients."
Sesen Bio also announced today that Abbie Celniker, Ph.D. and Paul Chaney have stepped down from the company’s board of directors, effective August 7, 2018. Dr. Celniker, who served on the board of directors since the company’s founding by Third Rock Ventures in 2011, is focusing on her partner role at Third Rock Ventures and early-stage portfolio-building efforts. Mr. Chaney joined the company’s board in 2014 as a leader in developing innovative ophthalmic therapeutics and is leaving to continue his efforts in that area of drug development.
"I am very proud of the progress and many milestones that the Sesen Bio team has achieved, and it has been a pleasure to serve on the board with this outstanding group of industry leaders," said Dr. Celniker. "The company is uniquely positioned with a Phase 3 trial that is well underway, established clinical data, a lead product candidate with a pipeline of opportunities and a strong balance sheet to fund its growing organization. I look forward to watching Sesen Bio’s continued success as a supportive investor with Third Rock Ventures."
In connection with the appointment of Dr. Cannell, Sesen Bio entered into an employment agreement with Dr. Cannell that, among other things, provides for the grant of a non-statutory stock option outside of the company’s 2014 Stock Incentive Plan as an inducement material to Dr. Cannell’s entering into employment with Sesen Bio in accordance with Nasdaq Stock Market Listing Rule 5635(c)(4). The stock option to purchase 1,350,000 shares of the company’s common stock is being granted effective as of August 7, 2018. The stock option grant was approved by the independent compensation committee of the board of directors in accordance with Nasdaq Stock Market Listing Rule 5635(c)(4). The stock option will have an exercise price per share equal to the closing price per share of Sesen Bio’s common stock on The Nasdaq Global Market on August 7, 2018. The stock option will have a ten-year term and will vest over a four-year period, with 25 percent of the shares underlying the stock option award vesting on the first anniversary of the date of grant and an additional 6.25 percent of the shares underlying the stock option vesting at the end of each successive three-month period following the one-year anniversary of the date of grant of the stock option, subject to Dr. Cannell’s continued service with the company through the applicable vesting dates.

On August 7, 2018 GT Biopharma Inc. (OTCQB: GTBP; Euronext Paris: GTBP) an immuno-oncology biotechnology company focused on innovative treatments based on the company’s proprietary platforms, reported that on August 2, 2018 it completed a private placement of convertible debentures for gross proceeds of $5,140,000 (Press release, GT Biopharma , AUG 7, 2018, View Source [SID1234539526]).

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”It is a testament to the potential of our immuno-oncology platforms and the promise for patients that our well informed and successful financing partners continue to support GT Biopharma as we move this company to the next level. Meeting our capital requirements is just one of many critical steps to advancing our drug development programs,” said Dr. Raymond W. Urbanski, Chairman and Chief Executive Officer of GT Biopharma.

The interest rate on the convertible debentures is 10%. The convertible debentures are convertible into the Company’s common stock, par value $0.001 per share, at an initial exercise price of $2 per share, subject to adjustment. The convertible debentures mature after one year.

On August 7, 2018 Myovant Sciences (NYSE: MYOV), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of women’s health and endocrine diseases, reported corporate updates and reported financial results for the first fiscal quarter ended June 30, 2018 (Press release, Myovant Sciences, AUG 7, 2018, View Source [SID1234528486]).

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"We are off to an excellent start to the year, highlighted by the completion of patient screening for our Phase 3 LIBERTY 1 trial evaluating relugolix in women with heavy menstrual bleeding associated with uterine fibroids, and screening in the replicate LIBERTY 2 trial expected to be completed this quarter," said Lynn Seely, M.D., President and Chief Executive Officer of Myovant Sciences. "We are at an exciting stage in the evolution of the Company, with top-line safety and efficacy data expected for relugolix in 2019 in three distinct indications, each with large markets and wholly owned North American and European rights."

Recent Business Highlights and Upcoming Milestones

On July 10, 2018, Myovant announced completion of patient screening for its LIBERTY 1 trial, the first of two Phase 3 replicate trials evaluating relugolix in women with heavy menstrual bleeding associated with uterine fibroids. Top-line safety and efficacy data from this trial are expected in the second quarter of 2019.
Screening for the LIBERTY 2 trial is anticipated to be completed this quarter.
Completion of enrollment and top-line safety and efficacy data from the two Phase 3 SPIRIT trials of relugolix in women with endometriosis-associated pain are expected in 2019.
Enrollment is expected to be completed in 2018 for the Phase 3 HERO trial of relugolix in men with advanced prostate cancer, and top-line safety and efficacy data are expected in 2019.
Myovant raised aggregate net proceeds of approximately $150.0 million during fiscal 2018 from the issuance and sale of 3,333,334 common shares in an underwritten public offering in July 2018, 1,110,015 common shares in a private placement to the Company’s controlling shareholder, Roivant Sciences, Ltd. in April 2018, and 2,767,129 common shares in an "at-the-market" equity offering program in April 2018.
On May 30, 2018, Myovant entered into a Commercial Manufacturing and Supply Agreement with Takeda Pharmaceutical Company Ltd. pursuant to which Takeda will manufacture and supply Myovant with relugolix drug substance to support the commercial launch of relugolix, if marketing authorization is granted. Takeda has also agreed to assist with the transfer of technology and manufacturing know-how to a second contract manufacturing organization of Myovant.
In May 2018, following the completion of a Phase 1 study, Myovant initiated a Phase 2a clinical trial in healthy female volunteers to characterize the dose-response curve in the controlled ovarian stimulation setting prior to studying MVT-602 in infertile woman seeking pregnancy.
On April 20, 2018, Myovant announced a partnership with PERIOD, Inc., a youth-led non-profit organization focused on menstrual equity, to elevate the conversation around period health, including an Ask Me About Periods campaign on college campuses around the country.
First Fiscal Quarter 2018 Financial Summary

Research and development (R&D) expenses for the quarter ended June 30, 2018, were $51.3 million compared to $17.7 million for the comparable period in 2017. The increase for the quarter primarily reflects the progress of Myovant’s ongoing Phase 3 clinical trials of relugolix, which were initiated in 2017, and additional personnel-related expenses.

General and administrative (G&A) expenses for the quarter ended June 30, 2018, were $8.7 million compared to $4.2 million for the comparable period in 2017. The increase for the quarter primarily reflects increases in personnel-related expenses, professional service fees, and other administrative expenses to support Myovant’s headcount growth and expanding operations.

Interest expense for the quarter ended June 30, 2018, was $1.6 million compared to no interest expense in the comparable prior year period. Interest expense for the quarter consisted of interest expense related to financing agreements with NovaQuest Pharma Opportunities Fund IV L.P. and Hercules Capital, Inc., as well as the associated non-cash amortization of debt discount and issuance costs.

Net loss for the quarter ended June 30, 2018, was $62.1 million, compared to $23.3 million for the comparable period in 2017. On a per common share basis, net loss was $0.98 and $0.39 for the quarters ended June 30, 2018, and 2017, respectively. The increases in the net loss and net loss per common share for the quarter were driven primarily by the increase in costs associated with Myovant’s ongoing Phase 3 clinical trials, which were initiated in 2017, as well as increased personnel-related expenses.

Capital resources: Cash and committed funding totaled $235.6 million at June 30, 2018, consisting of $143.6 million in cash and $92.0 million in remaining financing commitments available from NovaQuest under the NovaQuest Securities Purchase Agreement and the NovaQuest Equity Purchase Agreement. In the second quarter of fiscal year 2018, Myovant further strengthened its balance sheet, raising net proceeds of approximately $70.2 million from the issuance and sale of 3,333,334 common shares in an underwritten public offering. An additional $40.6 million of capacity remains available under the "at-the-market" equity offering program that Myovant initiated in April 2018.

About Relugolix

Relugolix is an oral, once-daily, small molecule that acts as a gonadotropin-releasing hormone, or GnRH, receptor antagonist that has been evaluated in approximately 1,600 study participants in Phase 1, Phase 2 and Phase 3 clinical trials. In these trials, relugolix has been shown to be generally well tolerated and to suppress estrogen and progesterone levels in women and testosterone levels in men. Common side effects observed were consistent with suppression of these hormones. In the ongoing Phase 3 LIBERTY clinical trials in women with heavy menstrual bleeding associated with uterine fibroids and the ongoing Phase 3 SPIRIT clinical trials in women with endometriosis-associated pain, relugolix is undergoing evaluation alone as monotherapy and in combination with estradiol and norethindrone acetate, a progestin. Myovant is studying whether the combination decreases estradiol levels to the range required to treat signs and symptoms of endometriosis and uterine fibroids while minimizing the side effects such as bone mineral density loss and hot flashes, associated with low estrogen levels. The ongoing Phase 3 HERO study is evaluating relugolix alone in men with advanced prostate cancer.

On August 7, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ:INO), a late-stage biotechnology company focused on the development and commercialization of DNA immunotherapies targeted against cancers and infectious diseases,reported financial results for the second quarter ended June 30, 2018, along with a general business update (Press release, Inovio, AUG 7, 2018, View Source [SID1234528502]). Inovio’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss Inovio’s financial results and provide a general business update.

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Inovio Highlights

VGX-3100 – HPV-related Precancers
REVEAL 1 Phase 3 trial enrollment on track. Opened a total of 70 sites across 16 countries and are actively recruiting for REVEAL 1, Inovio’s Phase 3 clinical trial for treating cervical dysplasia (CIN) caused by the human papillomavirus (HPV); the company anticipates opening approximately 90 sites globally by the end of August 2018. Also commenced during the quarter a Phase 2 clinical trial in its third indication to evaluate the efficacy of VGX-3100 in approximately 24 patients, adult men and women, with HPV-related anal dysplasia. This expansion increases the overall commercial value potential of our lead product, VGX-3100.
INO-5401 – Cancer
Dosed first patient in June as part of its Phase 1/2 immuno-oncology trial in patients with newly diagnosed glioblastoma (GBM); open-label, multi-center trial evaluating INO-5401 and INO-9012 in combination with cemiplimab in 50 newly diagnosed GBM patients with primary endpoint of safety and tolerability; the study will also evaluate immunological impact, progression-free survival and overall survival (see www.clinicaltrials.gov, identifier NCT03491683).
INO-5150 – Cancer
Presented prostate cancer data at ASCO (Free ASCO Whitepaper) 2018 where analyses showed clinically meaningful PSA stabilization post-administration of INO-5150 in patients with no documented disease progression during the study; of the 61 evaluable patients, 77% (47/61) demonstrated T cell immunogenicity; additional immunology data past week 27 is expected to be presented at a major oncology conference in the third quarter of 2018.
PENNVAX-GP – HIV
Presented data in May from a Phase 1 clinical trial in which Inovio’s HIV vaccine maintained durable and robust immune responses at month 12, a full 6 months after the last dose; 96% (26 of 27) of participants receiving PENNVAX-GP and IL-12 via IM delivery demonstrated a CD4+ T cell response, while the same percentage (96%, 27 of 28) of participants receiving the vaccine formulation via ID delivery also displayed anti-HIV CD4+ T cell responses; this data was presented at the 2018 HVTN Full Group Meeting in May.
INO-4700 (GLS-5300) – MERS
Reported positive Phase 1 results of Inovio’s collaborative vaccine study with INO-4700 (GLS-5300) against the MERS virus (Middle East Respiratory Syndrome); results showed that the vaccine was well-tolerated and approximately 95% of treated patients achieved overall high levels of antibody responses and approximately 90% of subjects also generated robust T cell responses. The new data was presented in June at the WHO-IVI Joint Symposium for MERS-CoV Vaccine Development.
Established partnership with CEPI
Signed a partnership agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) under which CEPI will directly fund up to $56 million to support Inovio’s pre-clinical and clinical advancement through Phase 2 of INO-4500, its Lassa fever vaccine, and INO-4700, its MERS vaccine, over a five-year period. Additional revenue is possible with vaccine stockpile post-Phase 2 testing.
Recognized revenue from ApolloBio Partnership
Received an upfront payment of $23 million (approximately $19.4 million after payment of required taxes) in March 2018 from ApolloBio, which gained the rights to develop, manufacture and commercialize VGX-3100 to treat precancers caused by HPV, within Greater China. This amount was recognized in Inovio’s reported revenue for the second quarter of 2018.
Cash Position
As of June 30, 2018, cash and cash equivalents and short-term investments were $95.6 million compared to $112.8 million as of March 31, 2018.
Dr. J. Joseph Kim, Inovio’s President & CEO said, "The second quarter included important strategic accomplishments for Inovio, while also providing shareholders with much to look forward to over the next 12 months. From presenting expanded data from our HIV developmental vaccine, PENNVAX-GP, to dosing our first patient with INO-5401 in our GBM trial, Inovio continues to showcase the versatility of our technology in both immunotherapy and infectious diseases. We continue to work diligently with our newly established partners ApolloBio, CEPI and the Parker Institute, while maintaining focus on opening sites and enrolling patients globally for our lead asset, VGX-3100, for treating patients with cervical dysplasia as well as capturing the overall commercial value potential of VGX-3100 through the expansion of our immunotherapeutic solution capabilities in HPV-related vulvar and anal precancers."

Second Quarter 2018 Financial Results

Total revenue was $24.4 million for the three months ended June 30, 2018, compared to $20.4 million for the same period in 2017. Total operating expenses were $29.7 million compared to $30.0 million for the same period in 2017.

As a result of the adoption of Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers, beginning on January 1, 2018, all contributions received from current grant agreements have been recorded as a contra-expense as opposed to revenue on the consolidated statement of operations. For the three months ended June 30, 2018, $1.9 million was recorded as contra-research and development expense, which amount would have been classified as grant revenue in the prior year. Had this change in presentation not occurred, total revenue would have been $26.3 million for the three months ended June 30, 2018, compared to $20.4 million for the same period in 2017. Total operating expenses would have been $31.6 million compared to $30.0 million for the same period in 2017.

Inovio’s net loss for the quarter ended June 30, 2018 was $6.6 million, or $0.07 per basic and $0.08 per diluted share, compared to $9.5 million, or $0.13 per basic and diluted share, for the quarter ended June 30, 2017.

Revenue

The increase in comparable revenue and grant agreement recognition for the second quarter of 2018 compared to 2017 was primarily due to the recognition of the gross up-front payment from ApolloBio of $23.0 million during the period (approximately $19.4 million after payment of required taxes). This increase was partially offset by $12.8 million in lower revenues recognized under Inovio’s collaborative research and development agreement with MedImmune, as previously deferred revenue totaling $13.8 million in the aggregate was recognized in June 2017 upon MedImmune’s selection of the first cancer research collaboration product candidate. Inovio also had a decrease in grant funding recognized from its DARPA Ebola grant of $2.2 million and a decrease in revenue of $2.1 million under its prior collaboration with Roche, as all remaining deferred revenue was recognized upon termination of that collaboration agreement in 2017, among other variances.

Operating Expenses

Research and development (R&D) expenses for the three months ended June 30, 2018 were $22.5 million compared to $23.9 million for the same period in 2017. The decrease in R&D expenses was primarily due to the $1.9 million contra-research and development expense recorded from grant agreements as discussed above, as well as a decrease of $2.1 million in expenses related to the DARPA Ebola grant. These decreases were slightly offset by an increase in employee headcount to support clinical trials and partnerships and an increase in expenses related to Inovio’s VGX-3100 clinical trials and its collaboration with MedImmune, among other variances.

General and administrative (G&A) expenses were $7.2 million for the three months ended June 30, 2018 versus $6.2 million for the same period in 2017.

Capital Resources

As of June 30, 2018, cash and cash equivalents and short-term investments were $95.6 million compared to $112.8 million as of March 31, 2018. As of June 30, 2018, the Company had 91.5 million common shares outstanding and 102.8 million common shares outstanding on a fully diluted basis, after giving effect to outstanding options, warrants, restricted stock units and convertible preferred stock.

Inovio’s balance sheet and statement of operations are provided below. Form 10-Q for the quarter ended June 30, 2018 providing the complete 2018 second quarter financial report can be found at: View Source

Conference Call / Webcast Information

Inovio’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss Inovio’s financial results and provide a general business update.

The live webcast and a replay may be accessed by visiting the Company’s website at View Source Telephone replay will be available approximately two hours after the call at 877-481-4010 (domestic) or 919-882-2331 (international) using replay ID 33743.