Other Events

On September 7, 2021 Provectus Biopharmaceuticals, Inc. (the "Company") reported to disclose the composition of its fully diluted shares of common stock, par value $.001 per share ("Common Stock"), outstanding as of the date hereof in comparison to its fully diluted shares of Common Stock outstanding in 2017 (Press release, 8-K, Provectus Biopharmaceuticals, SEP 7, 2021, View Source [SID1234587292]). The number of authorized shares of preferred stock and Common Stock of the Company are 25,000,000 and 1,000,000,000, respectively.

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2017 Fully Diluted Shares of Common Stock Outstanding

The Company reported on its Form 10-K for the calendar year ending December 31, 2016, filed with the U.S. Securities and Exchange Commission (the "SEC") on March 31, 2017, that certain equity securities were outstanding:

●364,773,297 shares of Common Stock, as of March 10, 2017,
●48,938,841 privately-held warrants to purchase Common Stock with exercise prices ranging from $0.85 to $3.00 ("Private Warrants"). These warrants were issued by the Company in conjunction with historical private placements and to Company consultants and advisors,
●28,482,344 publicly-traded warrants to purchase Common Stock with an exercise price of $0.85 ("Listed Warrants"). These warrants were issued by the Company in conjunction with a public offering that closed on June 24, 2015, and a registered exchange offer that expired on March 28, 2016,
●8,600 shares of the Company’s Series B Convertible Preferred Stock, par value $.001 per share ("Series B Preferred Stock"), and 112,570,356 warrants to purchase Common Stock with an exercise price of $0.0533 ("Ratchet Warrants"), both issued by the Company in conjunction with a public offering of equity securities that closed on August 30, 2016, and
●3,500,000 options to purchase Common Stock with strike prices ranging from $0.67 to $1.50 ("Stock Options"), issued by the Company-to-Company employees.

The warrants, options, and preferred stock described above were approved by the then-board of directors of the Company. The Company’s fully diluted shares of Common Stock outstanding in 2017 was 563,911,848 on an as converted basis.

2021 Fully Diluted Shares of Common Stock Outstanding

All Private Warrants attributed to historical private placements expired by October 31, 2020. All Listed Warrants expired on June 23, 2020.

The Company reported on its Form 10-K for the calendar year ending December 31, 2020, filed with the SEC on March 2, 2021, that certain equity securities were outstanding:

● 403,557,037 shares of Common Stock, as of February 28, 2021,
● 487,500 privately-held warrants with exercise prices ranging from $0.29 to $2.00,
● 100 shares of Series B Preferred Stock and 86,776,664 Ratchet Warrants, and
● 4,800,000 Stock Options with strike prices ranging from $0.12 to $1.04, issued to Company employees and consultants.

On June 20, 2021, all outstanding convertible promissory notes, totaling $30,560,080 of principal and accrued interest, issued as part of the Company’s 2017 and 2020 Financings and described in the Company’s Form 10-Q for the period ending March 31, 2017, filed on May 10, 2017 with the SEC, and in the Company’s Form 8-K, filed with the SEC on January 7, 2020, respectively, automatically converted into 12,373,247 shares of Series D Convertible Preferred Stock, par value $.001 per share (the "Series D Preferred Stock"), and 9,440,594 shares of Series D-1 Convertible Preferred Stock, par value $.001 per share (the "Series D-1 Preferred Stock"), which collectively are convertible into a total of 106,779,187 shares of Common Stock. For a description of the Series D Preferred Stock and Series D-1 Preferred Stock, see the Company’s Form 10-Q for the period ending June 30, 2021, filed with the SEC on August 12, 2021.

All remaining Series B Preferred Stock was converted into Common Stock on August 25, 2021. All Ratchet Warrants were exercised or expired by August 30, 2021; 13,352,966 were exercised between January 1 and August 30, 2021, and 68,723,698 expired on August 30, 2021.

The Company’s fully diluted shares of Common Stock outstanding as of September 7, 2021 is 528,667,356 on an as converted basis, which consists of 416,575,669 shares of Common Stock outstanding, 512,500 shares of Common Stock issuable upon exercise of warrants, 4,800,000 shares of Common Stock issuable upon exercise of options, and 106,779,187 shares of Common Stock issuable upon conversion of the Series D Preferred Stock and Series D-1 Preferred Stock.

Innate Pharma Announces Conference Call and Webcast for First Half 2021 Business Update

On September 7, 2021 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company"), reported that the Company will hold a conference call on Wednesday, September 15, 2021, at 2 p.m. CEST / 8 a.m. EDT, to give an update on business progress during the first half of 2021 (Press release, Innate Pharma, SEP 7, 2021, View Source [SID1234587291]).

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Participating in the call will be Innate’s Chief Executive Officer Mondher Mahjoubi, MD, Chief Medical Officer Joyson Karakunnel, MD, MSc, FACP, and Chief Financial Officer Frédéric Lombard, MBA.

Details for the Virtual Event

The live webcast will be available at the following link:

View Source

Participants may also join via telephone to ask questions by registering in advance of the event at View Source Upon registration, participants will be provided with dial-in numbers, a direct event passcode and a unique registrant ID that they may use 10 minutes prior to the event start to access the call. Call reminders will also be sent to registered participants via e-mail the day prior to the event.

This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com. A replay of the webcast will be available on the Company website for 90 days following the event.

Roche to present data from industry leading portfolio at ESMO 2021 showing significant progress in early stage and uncommon cancers

On September 7, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that new oncology data will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, which will be held 16-21 September, 2021 (Press release, Hoffmann-La Roche, SEP 7, 2021, View Source [SID1234587290]). With one of the broadest oncology pipelines and portfolios in the industry, Roche presentations include late-breaking abstracts featuring data in early-stage breast cancer and early-stage lung cancer, and a presentation on cancer of unknown primary (CUP), which has been selected for inclusion in the ESMO (Free ESMO Whitepaper) Press Programme.

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"Our data at ESMO (Free ESMO Whitepaper) 2021 show how we continue to pursue potentially transformative advances in breast and lung cancer, particularly in earlier stage settings where the chance for cure is highest," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Furthermore our efforts in personalised healthcare, exemplified by our insights in CUP, will help address the needs of many patients who are diagnosed at a late stage."

Breast Cancer Highlights
First phase II data will be presented from an interim analysis of giredestrant, a next-generation oral selective oestrogen receptor degrader (SERD), in neoadjuvant, ER-positive, HER2-negative early breast cancer. Over 70% of breast cancer cases are hormone receptor (HR)-positive, and there is a need for more effective and tolerable treatments, since up to 30% of patients develop resistance to standard of care treatments and in the adjuvant setting half of patients stop treatment due to the toll of side effects. Our efforts in this area represent a step towards making the treatment of patients with HR-positive breast cancer more effective and less debilitating in order to reduce the burden of treatment. This study further showcases Roche’s commitment to identifying meaningful treatment options for patients with breast cancer through a comprehensive development programme that includes early and late-stage HR-positive, HER2 positive and triple-negative forms of the disease.

Lung Cancer Highlights
New results from the phase III IMpower010 study, to be presented during Presidential Symposium Three, highlight patterns of relapse and subsequent therapy following treatment with Tecentriq (atezolizumab) versus standard of care in early lung cancer, and help to define how Tecentriq fits into the adjuvant treatment pathway. These findings are particularly important as real-world data, which will also be presented at ESMO (Free ESMO Whitepaper), will provide detail on the proportion of people with early NSCLC in the United States who do not receive adjuvant treatment despite guidelines recommending that they do so. These real world data also highlight survival outcomes in this setting and reinforce the need for more effective adjuvant therapy in NSCLC, as half of all people with early-stage lung cancer today still experience disease recurrence following surgery.

The phase III IMpower010 study showed adjuvant Tecentriq improved disease-free survival in PD-L1-positive early-stage lung cancer, compared with best supportive care – a first in cancer immunotherapy. Based on the outcomes from this study, the United States Food and Drug Administration recently granted Priority Review under the Real-Time Oncology Review pilot programme to Tecentriq as an adjuvant treatment for certain people with early NSCLC, and is expected to make a decision later this year.

Innovation in Personalised Healthcare
Latest results from a preliminary descriptive molecular analysis based on the CUPISCO study, which will be featured in the ESMO (Free ESMO Whitepaper) Press Programme, shed further light on the genomic profiles of patients with poor-prognosis CUP. These results highlight the importance of comprehensive genomic profiling for patients with CUP and identify therapeutically relevant genomic alterations in a significant proportion of patients, which may help to inform a more personalised treatment plan. In CUP, doctors cannot identify the location of the original (primary) tumour and can only find metastases. This causes practical problems since traditional treatment approaches rely on the site of origin being known, and as such, most patients are treated with nonspecific chemotherapy. Unfortunately, prognosis remains poor and the median survival following diagnosis is just six to 12 months, reinforcing the need for improved diagnosis and treatment.

Real world data from the United States examining the use of Foundation Medicine’s comprehensive genomic testing prior to first-line therapy in patients with metastatic colorectal cancer (mCRC) will also be presented and underpin Roche’s efforts to drive more widespread and earlier testing for patients with cancer.

Ahead of ESMO (Free ESMO Whitepaper), Roche will also be hosting a virtual Personalised Healthcare in Oncology Symposium for healthcare professionals on Thursday 9 September, 13:00 – 14:30 CEST. In this symposium, different healthcare system experts from across the world will discuss how new and emerging solutions in personalised healthcare can help to improve patient outcomes, and ultimately their quality of life.

LinkedIn Live event – COVID-19 and Cancer: Reshaping Patient Care in the Context of the Pandemic Today and Tomorrow
Roche will also be hosting a live roundtable discussion on Wednesday 15 September 2021, 16:00 CEST that will focus on the global efforts to overcome the impact of the COVID-19 pandemic on cancer outcomes. The discussion, featuring experts from medical societies, academia and patient groups, will focus on what lessons have been learned so far, and how stakeholders can forge new paths and partnerships to find and deliver solutions for patients and society. Join this event on Roche’s LinkedIn page here.

Roche Oncology Newsroom
Roche’s ESMO (Free ESMO Whitepaper) Oncology Newsroom will be available from Tuesday 7 September for journalists to access exclusive materials sharing insights into Roche’s latest data, vision and strategy to pursue and advance scientific progress in order to improve the lives of people living with cancer. To access the newsroom, please register here.

Keep up to date with ESMO (Free ESMO Whitepaper) news and updates by using the hashtag #ESMO21 and follow Roche on Twitter via @Roche and LinkedIn.

Overview of key presentations featuring Roche medicines

Medicine Abstract title Abstract or presentation number
Breast cancer
Giredestrant Neoadjuvant giredestrant (GDC-9545) + palbociclib (palbo) vs anastrozole (A) + palbo in post-menopausal women with oestrogen receptor-positive, HER2-negative, untreated early breast cancer (ER+/HER2– eBC): Interim analysis of the randomised, open-label, phase 2 coopERA BC study LBA14
Kadcyla Trastuzumab emtansine (T-DM1) in Asian patients with previously treated HER2-positive locally advanced (LA) or metastatic breast cancer (MBC): data from the phase 3 EMILIA study 284P
Kadcyla Trial in progress – ASTEFANIA: A phase 3 study of trastuzumab emtansine (T-DM1) plus atezolizumab or placebo as adjuvant therapy in patients with residual invasive breast cancer after neoadjuvant HER2-targeted therapy and chemotherapy 202TiP
Kadcyla Trial in progress – KATE3: A phase 3 study of trastuzumab emtansine (T-DM1) in combination with atezolizumab or placebo in patients with previously treated HER2-positive and PD-L1–positive locally advanced or metastatic breast cancer 329TiP
Real world data Real-world Outcomes of Hormone Receptor-Positive (HR+) HER2-Negative (HER2-) metastatic Breast Cancer (mBC) with High Tumor Mutational Burden (hTMB) Treated with Immune Checkpoint Inhibitors (ICI) 237P
Lung cancer
Tecentriq IMpower010: Patterns of relapse and subsequent therapy from a Phase III study of atezolizumab (atezo) vs best supportive care (BSC) after adjuvant chemotherapy (chemo) in stage IB-IIIA non-small cell lung cancer (NSCLC) LBA9
Tiragolumab Trial in progress – SKYSCRAPER-03: Phase III, Open-Label Randomised Study of Atezolizumab + Tiragolumab vs Durvalumab in Patients with Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed After Platinum-based Concurrent Chemoradiation (cCRT) 1190TiP
Atezolizumab Atezolizumab (atezo) vs platinum-based chemo in blood-based tumour mutational burden-positive (bTMB+) patients (pts) with first line (1L) advanced/metastatic (m)NSCLC: results of the Blood First Assay Screening Trial (BFAST) Phase 3 Cohort C 1281O
Real world data Real-world Adjuvant Treatment Patterns and Survival Outcomes among early NSCLC US Patients 1158P
Real world data Adoption and early clinical outcomes of atezolizumab (atezo) + carboplatin and etoposide (CE) in patients with extensive-stage small cell lung cancer (ES-SCLC) in the real-world (RW) setting 1650P
Bladder cancer
Atezolizumab Cisplatin (cis)-related immunomodulation and efficacy with atezolizumab (atezo) + cis- vs carboplatin (carbo)-based chemotherapy (chemo) in metastatic urothelial cancer (mUC) 658MO
Gastric cancer
Atezolizumab Phase Ib/II open-label, randomised evaluation of second-line atezolizumab (atezo) + linagliptin (lina) vs ramucirumab (ram) + paclitaxel (pac) in MORPHEUS-Gastric Cancer 1382P
Head and neck cancer
Tiragolumab Trial in progress – SKYSCRAPER-09: A Phase II, Randomised, Double-blinded Study of Atezolizumab (Atezo) + Tiragolumab (Tira) and Atezo + Placebo as First-line (1L) Therapy for Recurrent/Metastatic (R/M) PD-L1+ Squamous Cell Carcinoma of the Head and Neck (SCCHN) 927TiP
Hepatocellular carcinoma
Atezolizumab IMbrave150: exploratory efficacy and safety results in patients with hepatocellular carcinoma without macrovascular invasion (MVI) or extrahepatic spread (EHS) treated with atezolizumab (atezo) + bevacizumab (bev) or sorafenib (sor) 932P
Tumour agnostic treatment and personalised healthcare
Comprehensive genomic profiling Baseline mutational profiles of patients (pts) with carcinoma-of-unknown-primary-origin (CUP) enrolled onto CUPISCO 1804P
Comprehensive genomic profiling Fusion and rearrangement (RE) detection using DNA and RNA-based comprehensive genomic profiling (CGP) of sarcomas 1532P
Comprehensive genomic profiling Circulating tumor DNA (ctDNA) from patients (pts) with advanced colorectal cancer (CRC) is enriched for EGFR extracellular domain (ECD) mutations 457P
Tumour agnostic Blood tumor mutational burden (bTMB) and efficacy of immune checkpoint inhibitors (ICIs) in advanced solid tumors: SCRUM-Japan MONSTAR-SCREEN 80P
Real world data Comprehensive genomic profiling (CGP) and PD-L1 IHC in patients (pts) with advanced non-small cell lung cancer (aNSCLC): Testing and Treatment Patterns in the real-world (RW) setting 1301P
Real world data Utilisation and predictors of genomic testing prior to first-line (1L) therapy in patients (pts) with metastatic colorectal cancer (mCRC) 477P

About Roche in Oncology
Roche has been working to transform cancer care for more than 50 years, bringing the first specifically designed anti-cancer chemotherapy drug, fluorouracil, to patients in 1962. Roche’s commitment to developing innovative medicines and diagnostics for cancers remains steadfast. The Roche Group’s portfolio of innovative cancer medicines includes: Alecensa(alectinib); Avastin(bevacizumab); Cotellic(cobimetinib); Erivedge(vismodegib); Gavreto(pralsetinib); Gazyva/Gazyvaro(obinutuzumab); Herceptin(trastuzumab); Kadcyla(trastuzumab emtansine); MabThera/Rituxan(rituximab); Perjeta(pertuzumab); Polivy(polatuzumab vedotin); Tarceva(erlotinib); Rozlytrek(entrectinib); Tecentriq(atezolizumab); Venclexta/Venclyxto(venetoclax) in collaboration with AbbVie; Xeloda(capecitabine); Zelboraf(vemurafenib). Furthermore, the Roche Group has a robust investigational oncology pipeline focusing on new therapeutic targets and novel combination strategies. For more information on Roche’s approach to cancer, visit www.roche.com.

ROB GIETL JOINS PASCAL BIOSCIENCES AS NEW CHIEF EXECUTIVE OFFICER

On September 7, 2021 Pascal Biosciences Inc. ("Pascal") (TSXV:PAS) (OTC:PSCBF) (FSE: 6PB-FF), reported the appointment of Rob Gietl as Chief Executive Officer and President, and he will also have a position on the Board of Directors (Press release, Pascal Biosciences, SEP 7, 2021, View Source [SID1234587289]). Mr. Gietl has extensive experience leading several public companies in Canada, with an excellent record of effectively executing business plans, creating successful partnerships, and leveraging financial resources. As CEO of MYM Neutraceuticals, he oversaw the financing of $123M in the public markets.

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Mr. Gietl takes over from Dr. Patrick Gray who now becomes Chairman of the Board of Directors. "Rob is a great addition to Pascal, and we look forward to his direction of the company", said Dr. Gray. "His past operational experience will greatly help guide Pascal, and his financial expertise will create significant value for our shareholders." In industries as diverse as green technology, early-stage mining development, and cannabis neutraceuticals, he has been instrumental in numerous corporate start-up successes in Canada, the U.S, Mexico, and Australia.

Mr. Gietl commented, "Pascal is a dynamic company on the verge of attaining fantastic milestones in the biotechnology industry, and I’m excited to provide the direction to reach these goals." Pascal has several promising therapeutic programs, and Mr. Gietl will be tasked with prioritizing their direction and funding though corporate partnerships, non-dilutive funding, and public/private funding. "Pascal already has a corporate partnership with SoRSE Technology for their PAS-393 program, and an NIH grant for their leukemia program. We will grow Pascal in a manner most valuable to shareholders, and we expect to be a premier force in the biotechnology industry."

Pascal’s leadership team is dedicated to treating difficult diseases such as cancer. As Dr. Gray makes clear, "Rob’s exceptional background in operations and raising capital perfectly complements Pascal’s super research and development capabilities." Accordingly, the team enthusiastically welcomes Mr. Gietl to the company.

INVECTYS INC. TO PARTICIPATE IN THE 2021 H.C. WAINWRIGHT 23rd ANNUAL GLOBAL INVESTMENT CONFERENCE SEPTEMBER 13-15, 2021

On September 7, 2021 Invectys Inc. a clinical-stage immunotherapy company headquartered in Houston and dedicated to the development of a new generation of products for cancer patients, reported that Praveen Tyle, Ph.D., Invectys Inc. President and CEO will participate in the H.C, Wainwright 23rd Annual Global Investment Conference to be held virtually September 13-15, 2021 (Press release, Invectys, SEP 7, 2021, https://www.invectys.com/non-classe/invectys-inc-to-participate-in-the-2021-h-c-wainwright-23rd-annual-global-investment-conference-september-13-15-2021/ [SID1234587288]).

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Dr. Tyle will present on the topic titled "Novel Approaches to Tumor Eradication". Invectys, Inc focuses on a multi-modality approach to targeting HLA-G on tumor cells and also an approach with universal tumor antigen telomerase. The presentation is virtual and will be available on demand for the duration of the conference.

If you would like to set up a meeting, feel free to contact us at [email protected].