On February 18, 2021 Nordic Nanovector ASA (OSE: NANOV) reported its results for the fourth quarter and full year 2020 (Press release, Nordic Nanovector, FEB 18, 2021, View Source [SID1234575218]). A live webcast presentation by Nordic Nanovector’s management team will take place today at 08.30 CET. A link to the webcast and the presentation is available from the company’s homepage (www.nordicnanovector.com).

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Lars Nieba, interim Chief Executive Officer of Nordic Nanovector, commented: "The company has made significant efforts during 2020 to improve both the execution of PARADIGME and the chances of a viable regulatory filling outcome. The progress made, despite the challenging global environment, has been encouraging and we are pleased to see the enrolment rate into PARADIGME improving. We remain convinced of the commercial potential of Betalutin based on the competitive efficacy data that was seen at the time of the Interim Analysis and in earlier studies, which could allow it to address an important unmet need in advanced FL. We continue to work hard to ensure that we complete PARADIGME in a timely fashion such that we can report preliminary three-month top-line data in H2’2021."

Q4’2021 Highlights

Operational improvements and protocol changes implemented during 2020 have resulted in a significant recent acceleration in PARADIGME recruitment rate
Recruitment rate increased from approx. two patients to approx. five patients per month despite COVID
After the expected lessening of COVID restrictions plus the ongoing operational improvements, this rate could further increase to at least seven patients on average per month by late spring
73 patients enrolled as of 17 February 2021 (59 enrolled as of 18 November 2020)
14 patients were enrolled from November 2020 to 17 February 2021 (3 patients from Aug-Nov 2020)
Operational improvements that have significantly boosted PARADIGME recruitment include:
Much improved management of the study CRO
Appointment of a specialist firm focused on further improving the rate of recruitment
A broadening of the inclusion criteria based on safety data from the Interim Analysis is estimated to increase the size of the pool of eligible patients by 30-50%
Following interactions with FDA and an internal review, the company believes that it has clarity on the clinical data set (safety and efficacy) needed to support a filing at the designated dosing regimen of "40/15" and that this can be achieved with a reduction of the initially targeted population from 130 to 120 patients
On this basis, 47 more patients are required to complete PARADIGME for regulatory submission of Betalutin
Increased confidence in target of reporting preliminary three-month top-line data in H2’2021
Pipeline update: Final patients enrolled into second safety cohort of Archer-1 Phase 1 trial of Betalutin plus rituximab in 2L R/R FL and into LYMRIT 37-05 Phase 1 trial of Betalutin in patients with DLBCL
Preliminary data readouts expected in H1’2021
Both trials paused pending analysis of data and evaluation of plans for further development
Results of preclinical studies demonstrating Betalutin reverses tumour resistance to rituximab in NHL disease models published in Journal of Nuclear Medicine
Financial Highlights Q4 and FY’2020

(Figures in brackets = same period 2019 unless otherwise stated)

Revenues for the fourth quarter amounted to NOK 0.0 million (NOK 0.0 million). Revenues for the full year 2020 were NOK 0.0 million (NOK 0.0 million).
Total operating expenses for the fourth quarter were NOK 106.8 million (NOK 139.3 million). Total operating expenses for the full year 2020 amounted to NOK 434.2 million (NOK 440.4 million).
Research and development (preclinical, clinical, medical affairs, regulatory and CMC activities) expenses accounted for 84 of total operating expenses in 2020 (80 %).
Comprehensive loss for the fourth quarter amounted to NOK 112.1 million (loss of NOK 137.5 million). Comprehensive loss for the full year 2020 was NOK 417.6 million (NOK 433.2 million).
Cash and cash equivalents amounted to NOK 294.0 million at the end of December 2020 (NOK 470.8 million).
Outlook

Nordic Nanovector will continue to focus its resources on completing PARADIGME and continues to target the preliminary readout of three-month top line data from PARADIGME in H2’2021.

The company believes that, if positive, these trial data could represent a significant value inflection point for the company and its shareholders, confirming Betalutin as a highly promising new targeted radioimmunotherapy that can address the unmet needs of R/R FL patients.

The company has streamlined its organisation and taken further steps to conserve cash. Following the successful private placement in September 2020, Nordic Nanovector has a cash runway that extends into Q3’2021.

Despite the challenging times, the many positive actions the company has taken during 2020 have improved the prospects of delivering preliminary readout of three-month top line data from PARADIGME in H2’2021 although the future impact of COVID-19 remains uncertain and may still impact the trial timelines. However, the recent improvements in recruitment pace for PARADIGME, while the COVID-19 pandemic has been severe, are encouraging.

The company also expects the readout of three-month top line data from the second cohort of the Archer-1 trial and the LYMRIT 37-05 trial in DLBCL in H1’2021. As stated, the company will assess these data and evaluate its plans for further development in these important NHL indications.

Presentation and Live Webcast

A live webcast presentation by Nordic Nanovector’s management team will take place today at 08.30 CET. The webcast can be accessed from www.nordicnanovector.com in the section: Investors & Media and a recording will also be available on this page after the event.

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2020 from 7:00am CET the same day

On February 18, 2021 Oncopeptides AB reported that Year-end Report 2020 (Press release, Oncopeptides, FEB 18, 2021, View Source [SID1234575217]).

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Financial overview October 1 – December 31, 2020

Net sales amounted to SEK 0.0 M (0.0)
Loss for the period was SEK 513.0 M (loss: 244.9)
Loss per share, before and after dilution, was SEK 7.59 (loss: 4.42)
On December 31 cash and cash equivalents amounted to SEK 840.3 M (926.2)
Significant events during the period October 1 – December 31, 2020

First patient enrolled in the phase 3 LIGHTHOUSE combination study in multiple myeloma
Phase 2 ANCHOR data presented at ASH (Free ASH Whitepaper)
Oncopeptides announced the intention to apply for conditional marketing authorization of melflufen in the EU
The FDA accepted IND application to initiate clinical studies with OPD5, the company’s second candidate drug
A capital markets day was arranged with more than 250 participants online
Full data set from phase 2 HORIZON study published in the Journal of Clinical Oncology
Oncopeptides entered into a €40 M loan agreement with the European Investment Bank (EIB)
Extraordinary General Meeting held in December resolved to implement a long-term incentive program for US employees
Financial overview of the group

Conference call for investors, analysts and the media

Year-end Report 2020 and an operational update will be presented by CEO Marty J Duvall and members of Oncopeptides Leadership team, Thursday February 18, 2021 at 14:00 (CET).

The conference call will also be streamed via a link on the website: www.oncopeptides.com.

On February 17, 2021 Processa Pharmaceuticals, Inc. (NASDAQ: PCSA), ("Processa" or the "Company"), a clinical-stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have unmet medical needs, reported that it has executed a securities purchase agreement to raise gross proceeds of $10.2 million resulting from the sale of 1,321,132 shares through a private investment in public equity (PIPE) financing at a price of $7.75 per share (Press release, Processa Pharmaceuticals, FEB 17, 2021, View Source [SID1234578942]). The financing attracted both institutional and accredited investors. The closing of the private placement is subject to the satisfaction of customary closing conditions, expected to occur on or about February 23, 2021.

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"We believe these additional resources position us to further advance our pipeline of drug candidates for those patients who need better treatment options in cancer and gastroparesis as well as patients who have no real FDA approved treatment for Necrobiosis Lipoidica (NL)," said Dr. David Young, CEO and chairman of Processa. "We look forward to seeing the results from our interim analyses in the phase 1B PCS6422 study and the Phase 2B PCS499 study in the 2H 2021."

Tribal Capital Markets, LLC acted as sole placement agent for the offering. Allele Capital Partners, LLC through Tribal Capital Markets, LLC was responsible for sourcing and executing the offering.

The securities are being sold in a private placement and have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. The Company has agreed to file a resale registration statement with the U.S. Securities and Exchange Commission, for purposes of registering the resale of the ordinary shares issued or issuable in connection with the offering.

On February 17, 2021 Ferring Pharmaceuticals, Rebiotix Inc., a Ferring Company, and MyBiotics Pharma Ltd. reported a multi-year strategic collaboration to develop live microbiota-based biotherapeutics to address bacterial vaginosis, a common vaginal infection among women of reproductive age linked to increased risk of miscarriage and complications for pregnancy and fertility (Press release, MyBiotics, FEB 17, 2021, View Source [SID1234577655]). 1,2,3 The collaboration is an important step forward in harnessing the power of the human microbiome in this area of women’s health.

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Currently bacterial vaginosis is treated with antibiotics, which can disrupt the vaginal microbiome, and it’s common for bacterial vaginosis to return following treatment.4 The aim of a microbiota-based treatment would be to reduce the need for antibiotic use and provide a long-term treatment solution.

The multi-year agreement combines MyBiotics’ unique culturing, delivery and colonisation technologies aimed at restoring microbiome equilibrium with Rebiotix’s expertise in developing clinical-stage live microbiota-based biotherapeutic products and Ferring’s therapeutic development and commercial expertise. The new agreement builds on the existing collaboration between Ferring and MyBiotics, initiated in 2017, which has already successfully piloted technologies intended to stabilise selected bacterial species critical to the health of the female reproductive tract using MyBiotics’ MyCrobe technology.

"We are proud to be undertaking this collaboration, as it is a critical step forward in meeting patient needs through the potential of the microbiome," said Ken Blount, Chief Scientific Officer, Rebiotix and Vice President of Microbiome Research, Ferring Pharmaceuticals. "This collaboration with MyBiotics not only harnesses our collective expertise in developing live microbiota-based biotherapeutic technologies, but also reaffirms Ferring’s deep commitment to building families worldwide through innovations in reproductive medicine and maternal health."

The collaboration announced today also stands to add several firsts to Ferring’s microbiome product pipeline, including the company’s first non-donor derived formulation, and a live microbiota-based product specific to reproductive medicine.

"Today’s agreement is an important evolution of our long-standing relationship with Ferring in the field of microbiota-based therapies for the benefit of women’s health, including reproduction and pregnancy," said MyBiotics’ CEO, David Daboush. "We look forward to combining our innovative MyCrobe live bacteria culturing, delivery and colonisation technology with the world-leading development experience of Rebiotix for the benefit of women. The collaboration with Rebiotix builds on our successful collaboration with Ferring, and we are excited to build on that strong relationship targeted to bringing novel treatments to patients through our tailor-made microbiome technology platform."

MyBiotics has developed breakthrough and robust culturing, fermentation and delivery technologies for generating a highly stable and diverse bacterial community that can be efficiently delivered to different sites across the human body for restoring microbiome equilibrium. These technologies are effective for single microbes, complex microbial consortia and whole microbiome products, and are integrated with a computational AI platform, which enables the design of unique microbial consortia and whole microbiome profiles. The technologies are highly potent and suitable for patients with microbiome-related medical conditions.

The potential of live microbiota-based biotherapeutic products is an expanding frontier. The most clinically advanced formulations, derived from the human gut microbiome, are currently being developed to address Clostridioides difficile (C.diff) infection and have opened the door to harnessing the power of the microbiome to address other unmet medical needs. As the future of microbiome-based therapeutics expands, the potential extends beyond the gut to reproductive medicine. The ability to generate standardised, stabilised, approved formulations, created to serve patient needs in reproductive medicine and maternal health, connects to the core vision of both companies.

On February 17, 2021 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body’s own T cells to generate a specific, potent and durable immune response, reported the closing of its previously announced upsized initial public offering of 7,441,650 shares of its common stock at a price to the public of $17.00 per share, which includes the exercise in full by the underwriters of their option to purchase 970,650 additional shares (Press release, NexImmune, FEB 17, 2021, View Source [SID1234576168]). Including the option exercise, the gross proceeds to NexImmune from the offering, before deducting the underwriting discounts and commissions and estimated offering expenses, were approximately $126.5 million.

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Barclays Capital Inc., Cantor Fitzgerald & Co., Raymond James & Associates, Inc. and Allen & Company LLC acted as the joint book-running managers for the offering.

Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on February 11, 2021. The offering was made only by means of a prospectus. Copies of the final prospectus related to the offering may be obtained from: Barclays Capital Inc., Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: (888) 603-5847, or email: [email protected]; Cantor Fitzgerald & Co., Attention: Capital Markets Department, 499 Park Avenue, New York, NY 10022, or email: [email protected]; Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, FL 33716, telephone: (800) 248-8863, or email: [email protected]; or Allen & Company LLC., Attention: Prospectus Department, 711 Fifth Avenue, New York, NY 10022, telephone: (212) 339-2220, or email: [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.