On November 11, 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that management will participate in the 2021 Jefferies London Healthcare Conference (Press release, Spectrum Pharmaceuticals, NOV 11, 2021, View Source [SID1234595264]). A virtual fireside chat will be available to conference attendees, on-demand beginning on Thursday, November 18, 2021, at 3 a.m. ET / 8 a.m. GMT .

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The webcast of the fireside chat will also be available from the Investor Relations section of the company’s website at View Source at the same time.

On November 11, 2021 IMV Inc. ("IMV" or "the Company") (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing immune-educating cancer therapies, based on its novel DPX platform, that target solid and blood cancers while preserving patients’ quality of life, reported its financial and operational results and provided an update for the third quarter ended September 30, 2021 (Press release, IMV, NOV 11, 2021, View Source [SID1234595281]).

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"IMV is undergoing a pivotal transformation. We are realigning IMV’s strategy to focus on its core competencies in immuno-oncology. We intend to move maveropepimut-S (MVP-S) forward on the path to registrational trials and to leverage our versatile DPX platform to further develop a comprehensive portfolio of cancer immunotherapies, both in-house and with partners. As we explore the potential of our DPX delivery platform and the development of new DPX-based candidates, we are actively evaluating potential licensing opportunities for our programs outside of immuno-oncology," said Andrew Hall, interim Chief Executive Officer of IMV.

"Our recent clinical results and translational data are promising and demonstrate the potential of our lead compound in both solid and blood tumors. MVP-S continues to be well-tolerated across indications. We have seen sustained response in patients who had already gone through many lines of previous treatments." Mr. Hall continued. "Additionally, our second immunotherapy candidate, DPX-SurMAGE, has shown encouraging results in preclinical studies and demonstrates the platform’s potential to deliver across multiple therapeutic targets. Together, we believe that these results clearly support the expansion of our clinical oncology pipeline across a wider range of tumor antigens and indications both through in-house efforts and an acceleration of business development initiatives."

CLINICAL UPDATE

Maveropepimut-S (MVP-S)

Phase 2 DeCidE1 Study in Advanced, Recurrent Ovarian Cancer

Oliver Dorigo, M.D., Ph.D., Director and Associate Professor, Division Gynecologic Oncology, Department of Obstetrics and Gynecology at the Stanford University, CA, is presenting a poster describing translational data from the clinical study in patients with advanced, recurrent ovarian cancer at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.

Translational analyses showed that:
MVP-S treatment increased survivin-specific T and B cell tumor infiltration, further validating the MVP-S mechanism of action.
Immunogenic/inflamed tumors are more susceptible to treatment with MVP-S.
Potential mechanisms of primary resistance to treatment were identified.
IMV recently completed the DeCidE1 clinical trial evaluating MVP-S in association with low dose intermittent cyclophosphamide (CPA) in patients with advanced recurrent ovarian cancer. As announced in early August, the overall survival rate was 44.9% with a median overall survival of 19.9 months in a heavily pre-treated population at the two-year cut-off.

These results support further clinical evaluation. IMV expects to initiate a Phase 2B clinical trial in 2022.

Phase 2B VITALIZE Study in Relapsed/Refractory DLBCL ("r/r DLBCL").

MVP-S is currently being evaluated in a randomized Phase 2B clinical trial in combination with KEYTRUDA (pembrolizumab) and +/- intermittent low dose CPA in patients with r/r DLBCL. Recruitment has started now that multiple sites have been activated in North America.

IMV has designed the protocol to further validate the strong objective response rate observed in PD-L1 positive patients in the SPiReL Phase 2 trial.
DPX-SurMAGE in Bladder Cancer

Yves Fradet, M.D., Professor, Department of Surgery at the Faculty of Medicine, Université Laval in Quebec City presented preclinical data at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), showing that the DPX delivery platform can be leveraged to develop novel multi-targeted T-cell activating immunotherapies.

More specifically, these studies showed that it was possible to simultaneously elicit immune responses against two cancer antigens (survivin and MAGE-A9 proteins) in bladder cancer model.

The addition of intermittent low dose cyclophosphamide (CPA) did not significantly change the immune response. DPX-SurMAGE was well-tolerated in the preclinical models.

Based on these results, IMV is currently optimizing the design of a Phase 1 trial in non-muscle invasive bladder cancer patients which is expected to begin by year-end.

Foundational Research

A second poster presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) described that antigenic peptides, when packaged within the DPX platform, elicit specific T cell-based immune responses in a more robust and persistent manner than conventional water-based formulations.

CORPORATE UPDATE

Appointment of Joy Bessenger as SVP, Investor Relations and Corporate Strategy

Joy Bessenger was recently appointed as Senior Vice President of Investor Relations and Corporate Strategy of IMV. She brings over 17 years of experience in finance, corporate strategy and financial communications in the biotechnology and life sciences industries, with a particular focus on oncology, cell therapy and genomics. She has been actively involved in capital markets transactions and strategic planning for companies across a range of development stages. The first part of Joy’s career was spent on Wall Street in research and banking. Joy is based in New York.
Appointment of Heather Hirsch Ph.D. Vice President, Translational Research

Heather Hirsch was recently appointed as Vice President Translational Research of IMV. She brings more than 10 years of expertise in translational sciences having worked at Merck (MRK: NYSE), Jounce Therapeutics (JNCE: Nasdaq) and most recently at CRISPR Therapeutics (CRSP: Nasdaq). She has a strong background in immune-oncology, tumor microenvironment, and integrative translational analyses design to inform indication selection, mechanism of action and responder identification. Heather holds a PhD in cell and molecular biology from Michigan State University and completed post-doctoral fellowship at Harvard Medical School. Heather is based at IMV’s recently opened offices in Cambridge, Massachusetts.
Medicago Collaboration

IMV entered into a collaboration with Medicago, a biopharmaceutical company that develops virus-like particle (VLPs) against infectious diseases. The collaboration will evaluate Medicago’s VLPs encapsulated in IMV’s DPX technology. This agreement reflects IMV’s strategic shift in focus to seek licensing opportunities for its DPX platform in indications outside of immuno-oncology.
Overview of Third Quarter 2021 Financial Results

All dollar amounts noted herein are denominated in United States dollars (unless otherwise noted herein).

On September 30, 2021, the Company had cash and cash equivalents of $36.5 million and working capital of $37.3 million, compared with $36.3 million and $35.6 million, respectively at December 31, 2020. This increase primarily reflects net proceeds from the $25 million public offering completed on July 20, 2021, offset by cash used in operations year to date. Based on its current plan, IMV expects its current cash position will be sufficient to fund operations until Q3 2022.

Research and development expenses were $5.6 million for the three months ended September 30, 2021, compared with $4.9 million for the three months ended September 30, 2020. This increase of $0.7 million was mainly due to start-up costs for the Phase 2B VITALIZE study, an increase in manufacturing and development costs for MVP-S and an increase in headcount. These increases were partly offset by a decrease in development costs for DPX-COVID-19 following a shift in strategic focus.

General and administrative expenses were $5.3 million for the three months ended September 30, 2021, compared with $2.8 million for the three months ended September 30, 2020. This increase of $2.5 million was mainly attributable to an increase in salaries and non-cash stock-based compensation associated with planned hiring and executive leadership changes, foreign currency loss and, to a lesser extent, an increase in legal, professional, and recruitment fees.

Government assistance totaled $0.5 million for the three months ended September 30, 2021, compared with $1.3 million in Q3 2020. This decrease is mainly driven by a decrease in funding related to DPX-COVID-19 development costs.

The net loss and comprehensive loss of $10.4 million ($0.13 per share) for the three months ended September 30, 2021, was $5 million higher than the net loss and comprehensive loss of $5.4 million ($0.08 per share) for the three months ended September 30, 2020.

For the nine-month period ended September 30, 2021, the net loss and comprehensive loss of $24.9 million ($0.35 per share) was $7.5 million higher than the net loss and comprehensive loss of $17.4 million ($0.30 per share) for the nine-month period ended September 30, 2020.

As of November 10, 2021, the number of issued and outstanding common shares was 82,142,629 and a total of 16,289,495 stock options, warrants and deferred share units were outstanding.

The Corporation’s audited annual consolidated results of operations, financial condition and cash flows for the year ended December 31, 2020, and the related management’s discussion and analysis (MD&A) are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar as well as the Company’s website at www.imv-inc.com

SELECTED UPCOMING MILESTONES

Maveropepimut-S (MVP-S):

H2 2021: Submission of Phase 2 clinical study protocol in ovarian cancer for FDA review
H2 2021: Clinical update for the basket trial (Bladder & MSI-high tumor cancers)
H1 2022: Clinical update for the investigator-initiated breast cancer trial
Mid-2022: Clinical update for the open-label Phase 2 DLBCL trial
DPX-SurMAGE:

H2 2021: Initiation of a Phase 1 clinical study in bladder cancer at year-end
Conference Call and Webcast Information

Management will host a conference call and webcast today November 11, 2021, at 8:00 a.m. ET. Financial analysts are invited to join the conference call by dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (international) using the conference ID# 7079735

Other interested parties will be able to access the live audio webcast at this link: View Source The webcast will be recorded and will then be available on the IMV website for 30 days following the call.

On November 11, 2021 Kyowa Hakko Kirin reported that The National Institute for Health and Care Excellence (NICE) has published positive guidance, in the form of a Final Appraisal Determination (FAD), confirming that POTELIGEO (mogamulizumab) is recommended as a treatment option for adults in England and Wales with the ultra-rare blood cancers mycosis fungoides (MF) and Sézary syndrome (SS), two forms of cutaneous T-cell lymphoma (CTCL) (Press release, Kyowa Hakko Kirin, NOV 11, 2021, View Source [SID1234595297]). The treatment is approved for use after two prior systemic treatments for adults living with MF and after one prior systemic therapy for adults living with SS.1

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The FAD comes following a successful appeal lodged by Kyowa Kirin, Lymphoma Action, Leukaemia Care, and the UK Cutaneous Lymphoma Group (UKCLG) in response to a previous appraisal by NICE, published on 4 March 2021, that concluded POTELIGEO would not be made available on the NHS in England and Wales.2

All parties involved in lodging the appeal welcome the new, positive decision by NICE as it represents a distinctive step forward in addressing the high unmet clinical needs of those living with MF and SS. This decision also marks another milestone in the availability of POTELIGEO across the United Kingdom, following the acceptance of POTELIGEO by the Scottish Medicines Consortium (SMC) for adults living with MF and SS in Scotland on 7 June 20213.

Richard Johnson, Northern Cluster General Manager, responsible for the UK at Kyowa Kirin, said: "This is a momentous day for those living with MF and SS in the UK. By issuing positive guidance for POTELIGEO, NICE has helped ensure that those with MF and SS who have few systemic treatment options available to them are now able to access an innovative therapy. This decision is also testament to the dedication, commitment and long-term efforts of the broader CTCL community in advocating for a wider range of treatment options in the UK for those living with conditions like MF and SS."

Ropinder Gill, Chief Executive at Lymphoma Action, commented: "We’re really grateful and delighted with this decision. Mogamulizumab can have a life changing impact for those people affected by cutaneous T-cell lymphoma, a form of the rare condition skin lymphoma. They have limited treatment options – this is a great outcome for them. We were privileged to be part of the process alongside others, and to represent the patient voice with our patient advocate Stan."

Prof Julia Scarisbrick, consultant dermatologist and head of the Cutaneous Lymphoma Service within the Rare Diseases Centre at University Hospital Birmingham, added: "Adults living with CTCL have significant unmet clinical need and a lack of treatment options available to them. There has been a real need to address this for a long time and particularly so for those at the advanced stages of the disease, who have a poorer prognosis and impaired health related quality of life.4 With NICE’s decision, adults with MF and SS across the whole UK now have an effective, well tolerated therapy shown to improve quality of life available to them that can provide a welcome alternative to those who need it."

About POTELIGEO (mogamulizumab)

Mogamulizumab is a first-in-class humanised monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4), a protein consistently expressed on cancerous cells seen in both MF and SS;5,6,7 once mogamulizumab binds to CCR4, it increases attraction of immune cells from the immune system to destroy the cancerous cells.8

Mogamulizumab has been shown to offer benefits to many patients with MF and SS.9 The MAVORIC trial compared the efficacy of mogamulizumab with vorinostat in previously treated people with relapsed or refractory mycosis fungoides or Sézary syndrome, two types of Cutaneous T-cell lymphoma (CTCL).9 Patients taking mogamulizumab experienced control over their disease for more than twice as long as those taking the comparator treatment, vorinostat*1 (7.7 months vs 3.1 months of median progression free survival), the primary endpoint of the trial.9 Levels of adverse events were similar between the two treatment groups.9 The MAVORIC trial is the largest in CTCL; it enrolled a total of 372 patients across 61 sites in 11 countries (of which 16 sites were in Europe, including three in England).9

About Mycosis Fungoides (MF) and Sézary Syndrome (SS)

MF and SS are two forms of CTCL,10 which is a serious and potentially life-threatening form of cancer.11 Additionally, there is a significant impact on quality of life for those caring for an individual living with CTCL.12 CTCL is treatable but not curable and there has been a clear unmet need for new treatment options.

MF and SS are characterised by localisation of cancerous white blood cells called T lymphocytes (T cells), to the skin.13,14 These cancerous T cells consistently express a protein called CC-chemokine receptor 4 (CCR4), which enables them to move from the blood to the skin.5,6,7 When these cancerous T cells move to the skin, they can create a localised inflammatory immune skin response, commonly resulting in visible skin symptoms of red patches or plaques 5,15,16,17,18 which can resemble psoriasis or eczema.13

MF and SS can affect the skin, blood, lymph nodes (part of the body’s immune system which is spread throughout the body) and internal organs.19 All four areas of the body are used to assess disease stage20,21 and clinically significant involvement of the blood, particularly in more advanced disease, is linked with increased morbidity and an overall reduction in patient survival.20,22,23

CTCL can take, on average, between 2 and 7 years for individuals to receive a confirmed diagnosis.24 It is critical for doctors to consider CTCL as an early differential diagnosis as the patient’s prognosis can be affected if the disease progresses to later stages.25 Whilst most individuals that present with early stage disease do not progress to a more severe stage,26 patients with advanced disease have significantly poorer outcomes with only around half of patients (52%) surviving for just 5 years.20

CTCL is an ultra-rare disease that affects 0.7 per 100,000 patients across the UK.4 The annual incidence of MF in Europe is estimated to be between 1 in 110,000 to 1 in 350,000.27 The annual incidence of SS is 1 in 10,000,000.28 Together they represent approximately 65% of all cases of CTCL.19

On November 11, 2021 Vyant Bio, Inc. ("Vyant Bio", "Company") (Nasdaq: VYNT), an emerging global drug discovery company, reported that is rapidly identifying small and large molecule therapeutics to treat central nervous system (CNS) and oncology-related diseases (Press release, Vyant Bio, NOV 11, 2021, View Source [SID1234595434]). With leading-edge capabilities in data science, biological and chemical sciences, engineering, and regulatory affairs, Vyant Bio capitalizes on in silico, human cell-derived in vitro disease models, and in vivo discovery technologies to identify novel biological targets and valuable therapeutics for patients. Today, Vyant Bio reports its Third Quarter 2021 strategic and business updates in a conference call scheduled for 4.30pm ET.

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"We are pleased with the progress our R&D team is making to further our CNS rare disease and oncology related HER2+ drug discovery programs," stated Jay Roberts, CEO of Vyant Bio. The timing of Dr. Robert Fremeau’s arrival as our Chief Scientific Officer coincides well with our acceleration to later-stage drug discovery. Dr. Fremeau’s extensive experience with scientific research and drug discovery will be invaluable to us as we complete feasibility programs with leading biopharma companies, and develop our preclinical and translational strategy for driving a portfolio of therapeutic candidates from early discovery to human proof-of-concept".

"Vyant Bio is committed to transforming the way drugs are discovered by quickly adapting to exciting new technologies and combining our internal capabilities in ways that leverage the strength of our scientific and data science teams along with innovative technologies," stated Robert Fremeau, CSO of Vyant Bio. "Our internal teams of scientists, data scientists, and engineers, coupled with the capabilities of select strategic partners that are now integrated into our platform, allow us all to work together to design and develop superior therapeutics and position us to build a robust pipeline of novel therapeutics targeting degenerative and developmental neurological disorders and cancers with high unmet needs."

The Company expects to file its quarterly report for the Third Quarter 2021 on Form 10-Q tomorrow with the Securities and Exchange Commission. Please refer to Vyant Bio’s Form 10-Q for more detailed information with respect to our financial results for the three and nine months ended September 30, 2021.

THIRD QUARTER 2021 FINANCIAL RESULTS1

As StemoniX, Inc. was deemed to have acquired Cancer Genetics, Inc. for accounting purposes and the Merger closed on March 30, 2021, the Company’s Third Quarter 2021 financial results include the post-merger results of the combined companies, now known as Vyant Bio. The analysis below excludes the Third Quarter 2020 results as they are based solely on StemoniX’s historical stand-alone operations and therefore do not reflect the post-merger enterprise.

Cash and cash equivalents totaled $23.2 million as of September 30, 2021.

Total revenues were $1.5 million for the three months ended September 30, 2021. Cost of goods sold – service aggregated to $1.1 million for the three months ended September 30, 2021 resulting in a cost of goods sold of 80% of service revenues. Cost of goods sold – product aggregated to $159 thousand for the three months ended September 30, 2021 resulting in a cost of goods sold gross margin deficit of $196 thousand. Our product manufacturing capabilities currently have excess capacity to support future growth. Research and development expenses were $1.2 million for the three months ended September 30, 2021. Selling, general and administrative expenses were $3.3 million for the three months ended September 30, 2021.

While the Company executes its drug development strategy for long-term growth, the Company currently generates revenue from its vivoPharm and StemoniX subsidiaries. On a pro forma basis, assuming the Merger occurred on January 1, 2020, revenues for the three and nine-month ended September 30, 2021 were $1.5 million and $5.3 million, respectively, as compared with $1.9 million and $5.0 million for the respective prior-year periods. On a pro forma basis, revenues (decreased) increased by (21)% and 5% in the current-year three and nine-month periods as compared with the same prior-year periods.

1Pro forma information gives effect to the Merger between Cancer Genetics, Inc. and StemoniX, Inc. as if the Merger had occurred as of January 1, 2020. The pro forma information is presented solely for informational purposes and is not necessarily indicative of the combined results of operations or financial position that might have been achieved for the periods or dates indicated, nor is it necessarily indicative of the future results of the Company.

Vyant Bio’s Conference Call and Webcast and Information

Vyant Bio’s management will host a conference call on Thursday, November 11, 2021 at 4:30 pm ET to discuss the Third Quarter 2021 results and provide strategic business updates as well as answer questions. Event information is below:

The live event will be recorded and available for replay. The conference call and webcast details are also included inside the Investors section of the Vyant Bio corporate website at www.vyantbio.com.

On November 11, 2021 Oasmia Pharmaceutical reported that it will publish its Q3 2021 report on November 18, 2021, at 08.00 am CET (Press release, Oasmia, NOV 11, 2021, View Source [SID1234595248]).

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The company will hold a conference call and an online presentation on the same day at 10.00 am CET. The call will be hosted by CEO Francois Martelet and CFO Fredrik Järrsten. The presentation will be in English.
The conference call will be broadcast live on the web via the link:
View Source