On May 17, 2021 Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare and orphan diseases, reported that members of its senior management team will participate in three upcoming virtual investor conferences (Press release, Cerecor, MAY 17, 2021, View Source [SID1234580115]).

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2021 RBC Capital Markets Global Healthcare Virtual Conference
Date: Tuesday, May 18, 2021
Time: 8:35 AM ET

Oppenheimer Rare & Orphan Disease Summit
Date: Friday, May 21, 2021
1×1 meetings only

Jefferies Virtual Healthcare Conference
Date: Wednesday, June 2, 2021
Time: 1:00 PM ET

A live webcast of the presentation at the 2021 RBC Capital Markets Global Healthcare Virtual Conference and the Jefferies Virtual Healthcare Conference can be accessed under the "News/Events" page in the Investors section of the Company’s website at www.cerecor.com.

On May 17, 2021 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, reported financial results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Vaccinex, MAY 17, 2021, View Source [SID1234580155]).

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"During the first quarter and subsequent period, we achieved notable progress across our proprietary clinical programs in cancer and neurology as well as our technology partnerships," stated Maurice Zauderer, Ph.D., president and chief executive officer. "We were very pleased to announce the commencement of our Phase 2 clinical trial of pepinemab in combination with KEYTRUDA for front-line, recurrent or metastatic head and neck cancer, a solid tumor indication in which SEMA4D is highly expressed. This represents an expansion of our development pipeline and, together with the recently published results of our non-small cell lung cancer trial, we believe that pepinemab can be a valuable new addition to cancer immunotherapy.

"Continued analysis of the full data set from our Phase 2 SIGNAL trial in Huntington’s disease indicates that pepinemab can provide a cognitive benefit in this and potentially other neuroinflammatory and neurodegenerative indications with significant unmet medical needs. To that end, we remain on track to initiate a Phase 1/2a trial of pepinemab in Alzheimer’s disease by the end of the second quarter while we continue to engage in discussions with potential partners regarding a planned Phase 3 trial in Huntington’s disease.

"Finally, during the quarter we announced that we entered into a licensing agreement with Surface Oncology following on delivery and qualification of a fully human anti-CCR8 antibody. This is meaningful as we continue to leverage our proprietary ActivMab platform as a potential source of non-dilutive funding that can help advance our other programs."

Pepinemab Clinical Updates:

Head and Neck Cancer. Subsequent to the end of the first quarter, Vaccinex announced it initiated a Phase 2 clinical trial evaluating pepinemab in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for advanced, recurrent or metastatic head and neck cancer. Multiple prior studies suggest that inhibition of SEMA4D increases immune infiltration and alters the balance of cytotoxic and immunosuppressive cells in the tumor microenvironment. As SEMA4D is highly expressed in head and neck cancer, we believe there is a strong rationale for development in this indication.
The study is expected to enroll up to 65 subjects and key endpoints are expected to include objective response, duration of response, progression free survival and overall survival.

Alzheimer’s Disease. By the end of the second quarter, Vaccinex intends to initiate a Phase 1/2a clinical trial of pepinemab in Alzheimer’s disease, funded in part by a $750,000 development grant from the Alzheimer’s Association under the 2020 Part the Cloud Program, as well as a $3 million award from the Alzheimer’s Drug Discovery Foundation.
The awards are based in part on earlier findings that treatment with pepinemab prevented the characteristic loss of glucose transport in the brain during underlying Huntington’s disease progression as detected by conventional FDG-PET imaging. Uptake of glucose, the main source of energy in the brain, is also known to decline with underlying disease progression in Alzheimer’s disease, and multiple studies in Alzheimer’s disease have shown that decline in glucose transport correlates with cognitive decline. The randomized, placebo-controlled, multi-center study is anticipated to enroll 40 subjects for 12 months treatment duration.

Huntington’s disease. Based on analysis of the full data set from the Phase 2, double-blind, placebo-controlled SIGNAL trial of pepinemab in patients with early manifest Huntington’s disease (HD), Vaccinex determined that pepinemab appeared to confer cognitive benefit to patients as determined from results of the Huntington’s Disease Cognitive Assessment Battery (HD-CAB). As a result, Vaccinex believes that a phase 3 trial is warranted and is currently engaged in discussions of such a study with several potential pharmaceutical partners.
Other Trials. Pepinemab is also being evaluated in multiple investigator-sponsored trials (ISTs) being conducted by the Winship Cancer Institute of Emory University to evaluate pepinemab in combination with checkpoint inhibitors in short term "Window of Opportunity" studies in colorectal, pancreatic, and head and neck cancer and melanoma.
Other First Quarter and Recent Accomplishments:

Announced the publication of results from the CLASSICAL-Lung phase 1b/2 clinical trial in non-small cell lung cancer in the peer-reviewed journal Clinical Cancer Research. The publication presents data showing that pepinemab is clinically active when combined with BAVENCIO, a checkpoint inhibitor, and that the combination was well-tolerated with no major new safety signals identified. It was of particular interest that the combination appeared to extend treatment benefit to immunotherapy naïve patients whose tumors were PD- L1 negative or low, a patient population that has, in general, been less responsive to immunotherapy. Combination treatment also appeared to halt or reverse tumor progression (partial response or stable disease) in select patients with primary or acquired resistance to anti-PD-1/L1 therapy.
Entered into multi-project deals with two leading pharmaceutical companies focused on leveraging Vaccinex’s ActivMAb antibody discovery and novel viral display platform for drug discovery against difficult but important multi-pass membrane receptors such as GPCR and ion channels.
Announced that Surface Oncology will be exercising its option to license an anti-CCR8 antibody discovered using Vaccinex’s ActivMAb platform. The terms of agreement with Surface Oncology providedthat Surface Oncology pay technology access and licensing fees to Vaccinex in addition to providing research funding, and that Vaccinex will qualify for development milestone payments and royalties.
Raised $32 million in net proceeds through its existing open sale market agreement, or ATM, facility.
Upcoming Anticipated Milestone Dates:

Q2 2021 – Initiation of Alzheimer’s disease Phase 1/2a trial
Mid-2022 – Initial data from open label head and neck cancer trial
Late 2022/Early 2023 – Data from randomized Alzheimer’s trial
Financial Results for the Three Months Ended March 31, 2021:

Revenue. Revenue for the three months ended March 31, 2021 was $850,000. The Company’s revenues were generated from the licensing arrangement with Surface Oncology.

Research and Development Expenses. Research and development expenses for the three months ended March 31, 2021 were $5.5 million as compared to $5.4 million for the comparable period in 2020.

General and Administrative Expenses. General and administrative expenses for the three months ended March 31, 2021 were $1.6 million as compared to $1.8 million for the comparable period in 2020.

Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on March 31, 2021 were $29.4 million, as compared to $10.6 million as of December 31, 2020. The increase in cash was a result of $32 million in net proceeds raised by the Company through its ATM facility.

On May 17, 2021 Soteria Biotherapeutics, Inc. ("Soteria"), a privately-held, immuno-oncology company focused on developing a next generation of switchable bispecific T-cell engagers to treat patients with solid tumor cancers, reported a $42 million Series A financing led by Roche Venture Fund and 5AM Ventures with participation from other leading investors, including M Ventures, Novartis Venture Fund and Alexandria Venture Investments (Press release, Soteria Biotherapeutics, MAY 17, 2021, View Source [SID1234580173]).

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Soteria’s T-LITETM T-cell engagers are selectively switched on through oral administration of a small-molecule activator to modulate potent T-cell activity by controlling the timing, duration, and level of bispecific complex formation. This switchable activity enables precise on/off control over the timing and magnitude of T-cell redirection and cytotoxic activity. Unlike conventional T-cell engagers which lack a control switch and therefore are associated with significant side effects, Soteria’s T-LITE therapies are being designed to allow physicians to modulate T-cell activity to maximize efficacy while minimizing side effects.

"Soteria’s technology has the potential to revolutionize the T-cell engager field with its proprietary approach designed to control and target potent biologic immune activators to attack tumors," said Nisha Marathe, investment director at Roche Venture Fund. "Specifically, we believe the T-LITE technology is highly differentiated, where the potent activity of a T-cell engager can be selectively switched on by small-molecule activators to direct tumor cytotoxicity and reduce cytokine release syndrome, ultimately resulting in a therapy with potentially greater safety and efficacy."

"These funds will support the advancement of our technology and allow us to build a pipeline of T-LITE development candidates with potential in well validated cancer targets," said Kristine Ball, chief executive officer of Soteria. "We appreciate the confidence and vision this syndicate of premier investors has shown in our opportunity to disrupt the T-cell engager field and our potential to create differentiated, potent therapies against solid tumors."

Company Founders and Leadership
Soteria’s team of founders, management and board members brings together accomplished leaders from academia and the biopharma industry with successful track records discovering and developing therapeutics at companies such as Abgenix, Ascendis Pharma, AstraZeneca/Medimmune, Exelixis, Genentech/Roche, KAI (acquired by Amgen), Labrys (acquired by TEVA), Merck Research Laboratories, Novartis, Relypsa (acquired by Vifor) and Sunesis:

Kristine Ball, Chief Executive Officer and Member of the Board
Zachary Hill, PhD, Co-Founder and SVP, Chief Scientific Officer, and Member of the Board
Mohammad Tabrizi, PhD, VP Preclinical Development
Alex Martinko, PhD, Co-Founder and Senior Director of Protein Science
Jim Wells, PhD, Academic Co-founder, Chair of Scientific Advisory Board, and Professor of Pharmaceutical Chemistry at UC San Francisco
Steven P. James, Board Chair and Chief Executive Officer of Pionyr Immunotherapeutics
David Allison, PhD, Member of the Board and Partner at 5AM Ventures
Keno Gutierrez, PhD, Member of the Board and Vice President at M Ventures
Nisha Marathe, PhD, Member of the Board and Investment Director at Roche Venture Fund
David Morris, MD, Member of the Board and Operating Partner at Novartis Venture Fund
Momo Wu, PhD, Member of the Board and Portfolio Investment Manager at Emerson Collective

On May 17, 2021 Nuvo Pharmaceuticals Inc. (TSX: MRV) (OTCQX: MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), a Canadian-focused healthcare company with global reach and a diversified portfolio of commercial products, reported its financial and operational results for the three months ended March 31, 2021 (Press release, Nuvo Pharmaceuticals, MAY 17, 2021, View Source [SID1234580427]). For further details on the results, please refer to Miravo’s Management, Discussion and Analysis (MD&A) and Condensed Consolidated Interim Financial Statements for the three months ended March 31, 2021, which are available on the Company’s website (www.miravohealthcare.com). All figures are in Canadian dollars, unless otherwise noted.

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Key Developments
Three months ended March 31, 2021 include the following:

Adjusted total revenue(1) was $14.5 million, a decrease of 23% compared to $18.9 million for the three months ended March 31, 2020.
Adjusted EBITDA(1) was $4.4 million, a decrease of 45% compared to $8.0 million for the three months ended March 31, 2020.
Revenue related to Blexten and Cambia was $5.6 million, a decrease of 7% compared to revenue of $6.0 million for the three months ended March 31, 2020. Total Canadian prescriptions of Blexten and Cambia increased by 22% and 9% compared to the three months ended March 31, 2020.
The Company repaid $3.6 million (US$2.9 million) of the Amortization Loan to Deerfield Management Company, L.P. (Deerfield).
As at March 31, 2021, cash and cash equivalents were $23.8 million.
(1) Non-International Financial Reporting Standards (IFRS) financial measure defined by the Company below.

Business Update

As a result of the COVID-19 pandemic, the Company has made changes to operations to promote a healthy and safe environment for its employees, while the business continues to supply global partners, wholesalers, pharmacies, and ultimately patients, with its healthcare products. The possibility of future supply disruptions resulted in forward buying linked to the COVID-19 pandemic, which increased revenue in the three months ended March 31, 2020. It is anticipated that the COVID-19 pandemic may continue to impact the timing of revenue in future quarters and the Company will monitor market dynamics accordingly.
In April 2021, the Company filed and obtained a receipt for a final base shelf prospectus with the securities regulatory authorities in each of the provinces of Canada (the Prospectus). The Company has filed the Prospectus to maintain financial flexibility and to have the ability to offer the securities on an accelerated basis pursuant to the filing of prospectus supplements. The Prospectus is valid for a 25-month period, during which time the Company may offer and issue, from time-to-time, common shares, preferred shares, debt securities, warrants and subscription receipts, or any combination thereof, having an aggregate offering value of up to $40 million.
In February 2021, Nuvo Pharmaceuticals (Ireland) DAC trading as Miravo Healthcare (Miravo Ireland) entered into an exclusive license and supply agreement (the License Agreement) with The Mentholatum Company for the right to commercialize the Resultz formula and technology in the United States under the Mentholatum brand. Miravo Ireland will earn revenue from The Mentholatum Company pursuant to the License Agreement. It is anticipated that The Mentholatum Company will launch Resultz during the summer of 2021. Resultz is currently manufactured by the Company’s contract manufacturing partner in Europe.
In January 2021, the Company launched NeoVisc ONE 4 mL and NeoVisc + 2 mL in Canada. Both NeoVisc+ and NeoVisc ONE were issued a Medical Device License by Health Canada in September 2020 for the treatment of pain and improvement of joint functionality in patients affected by degenerative (age-related changes) or mechanical arthropathy (related to overuse) of the knee.
In January 2021, the Company’s exclusive partner for Pennsaid 2% in Switzerland, Gebro Pharma AG (Gebro Pharma), launched the product into the Swiss market, generating net sales and related royalty revenue for Miravo.
"Our key promoted brands, Blexten and Cambia, continued their solid performance and demonstrated year-over-year gains in prescription growth. New prescriptions of Blexten (a measure of new patients to the product) grew by 17% compared to Q1 2020. Wholesaler and pharmacy buying patterns reverted to more traditional levels, as we did not see a repeat of the forward buying that occurred in Q1 2020 in response to the uncertainty around the COVID-19 pandemic. Our recently launched Suvexx and NeoVisc brands are performing according to plan and are already achieving meaningful market share. Feedback from healthcare providers and patients in relation to both products has been encouraging. In a recent market research study conducted for our marketing team, 95% of physicians surveyed, expect to increase the number of Suvexx prescriptions for their migraine patients," said Jesse Ledger, Miravo’s President & CEO. "We remain optimistic that with the accelerated roll out of COVID-19 vaccination programs across Canada and around the world, patients will gain improved access to healthcare providers during the remainder of the year and we anticipate this will result in demand for products across all our business segments."

First Quarter 2021 Financial Results
Adjusted total revenue was $14.5 million for the three months ended March 31, 2021 compared to $18.9 million for the three months ended March 31, 2020. For the three months ended March 31, 2021, the decrease in the Licensing and Royalty Business segment was primarily due to a $2.2 million decrease of the royalty earned on U.S. net sales of Vimovo due to a competitor launching a generic version of Vimovo in March 2020. During the three months ended March 31, 2021, the Company received a royalty of 10% based on U.S. net sales of Vimovo. In subsequent quarters, this royalty is anticipated to decrease to 5% of U.S. net sales of Vimovo due to a royalty step-down provision in Miravo Ireland’s license agreement with Horizon Therapeutics plc that is anticipated to be triggered as a result of continued generic competitor market share gains. Adjusted total revenue attributable to the Commercial Business segment declined during the three months ended March 31, 2021, as an increase in sales related to certain promoted products was more than offset by a decline in revenue from the segment’s mature products. During the comparative quarter, the possibility of future supply disruptions resulted in forward buying linked to the COVID-19 pandemic, which increased revenue in the Company’s Commercial Business segment in the three months ended March 31, 2020. The Production and Service Business segment revenue decreased as a result of a decline in the Company’s Resultz product sales.

Adjusted EBITDA was $4.4 million for the three months ended March 31, 2021 compared to $8.0 million for the three months ended March 31, 2020. The decrease in the current quarter was primarily attributable to a decrease in gross profit and an increase in sales and marketing expenses, slightly offset by a decrease in general and administrative expenses.

Non-IFRS Financial Measures
The Company discloses non-IFRS measures (such as adjusted total revenue, adjusted EBITDA, adjusted EBITDA per share and cash value of loans) that do not have standardized meanings prescribed by IFRS. The Company believes that shareholders, investment analysts and other readers find such measures helpful in understanding the Company’s financial performance and in interpreting the effect of the Aralez Transaction and the Deerfield Financing on the Company. Non-IFRS financial measures do not have any standardized meaning prescribed by IFRS and may not have been calculated in the same way as similarly named financial measures presented by other companies.

Adjusted Total Revenue
The Company defines adjusted total revenue as total revenue, plus amounts billed to customers for existing contract assets, less revenue recognized upon recognition of a contract asset. Management believes adjusted total revenue is a useful supplemental measure to determine the Company’s ability to generate cash from its customer contracts used to fund its operations.

The following is a summary of how adjusted total revenue is calculated:

Adjusted EBITDA
EBITDA refers to net income (loss) determined in accordance with IFRS, before depreciation and amortization, net interest expense (income) and income tax expense (recovery). The Company defines adjusted EBITDA as EBITDA, plus amounts billed to customers for existing contract assets, inventory step-up expenses, stock-based compensation expense, Other Expenses (Income), less revenue recognized upon recognition of a contract asset and other income. Management believes adjusted EBITDA is a useful supplemental measure to determine the Company’s ability to generate cash available for working capital, capital expenditures, debt repayments, interest expense and income taxes.

The following is a summary of how EBITDA and adjusted EBITDA are calculated:

1) The Company’s derivative liabilities are measured at fair value through profit or loss at each reporting date. As a result of the increase in the share price in the current quarter and an increase in the volatility of the Company’s shares, amongst other inputs, the value of the Company’s derivative liabilities increased and the Company recognized a net non-cash $18.4 million loss on the change in fair value of derivative liabilities for the three months ended March 31, 2021.

Virtual Annual Meeting of Shareholders
Miravo’s 2021 Annual Meeting of Shareholders (Meeting) will be held as an online meeting only. The Meeting will take place on Monday, May 17, 2021 (today) at 9:00 a.m. Registered shareholders can attend the Meeting online, vote shares electronically if they have not voted by proxy in advance of the Meeting in accordance with the proxy instructions, and submit questions during the Meeting. You will need to have your 16-digit Control Number (the Control Number) to participate in the Meeting. If you are a shareholder and do not have a Control Number or if you are not a Miravo shareholder, you can attend the Meeting as a guest, but you will not be able to vote at the Meeting.

The link to participate in the Meeting is: www.virtualshareholdermeeting.com/mrv2021. If you encounter any difficulties accessing the virtual meeting during the check-in or meeting time, please call the technical support number that will be posted on the Virtual Shareholder Meeting log in page.

On May 17, 2021 PerkinElmer, Inc. (NYSE: PKI) ("PerkinElmer") and Immunodiagnostic Systems Holdings PLC (LSE: IHS) ("IDS") reported that they have reached an agreement on the terms of a recommended all cash offer whereby PerkinElmer will acquire IDS for approximately $155 million (£110 Million) (Press release, PerkinElmer, MAY 17, 2021, View Source [SID1234580073]). The transaction has a total enterprise value of approximately $124 million (£88 Million) and is expected to close early in the third quarter of 2021, subject to approvals from the shareholders of IDS, sanction by the High Court of Justice in England and Wales and other customary closing conditions for a public takeover in the United Kingdom.

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Through this acquisition, PerkinElmer will be able to grow its overall Diagnostics business and specifically its immunodiagnostics segment. Moreover, the deal will enable PerkinElmer to combine its channel expertise and testing capabilities with IDS’s best-in-class chemiluminescence products in endocrinology, autoimmunity and infectious diseases to better serve customers around the world.

IDS’s portfolio and expertise will seamlessly integrate within EUROIMMUN, a PerkinElmer company since 2017. EUROIMMUN is a global leader in autoimmune testing and an emerging force in infectious disease, allergy and molecular genetic testing.

Wolfgang Schlumberger, CEO of EUROIMMUN, remarked, "This proposed transaction is highly valuable for both parties as the respective product lines are to a large extent complementary. The cooperation of our global distribution channels, the expansion of the immunoassay portfolio in closely related indication fields and IDS’s fully automated random access chemiluminescence platform strengthens our presence in immunodiagnostics. Our customers will benefit from a broader range of assays and laboratory diagnostic workflows. We are excited about these new opportunities and we look forward to welcoming Immunodiagnostic Systems into the PerkinElmer family following the completion of the transaction."

Headquartered in Boldon, the United Kingdom, IDS is a leading in-vitro diagnostic solution provider to the clinical laboratory market. IDS develops, manufactures, and markets innovative immunoassays and automated immunoanalyzer technologies to provide improved diagnostic outcomes for patients. IDS’s immunoassay portfolio is a combination of an endocrinology specialty testing menu and assay panels in complementary fields. IDS has approximately 300 global employees.

PerkinElmer’s comprehensive global diagnostics portfolio includes solutions focused on: reproductive health; autoimmune, infectious disease and allergy testing; gene analyses; and genomics offerings for oncology and other molecular tests through its wide range of instruments, reagents, assay platforms and software offerings.

In terms of financial impact, PerkinElmer expects the acquisition to be modestly accretive to non-GAAP earnings in year-one following the close, and PerkinElmer forecasts IDS’s business to be attractively positioned in markets that are projected to grow at a compound annual growth rate of high-single digits over the next few years.