On August 19, 2021 ArcticZymes Technologies (OSE: AZT) reported sales of NOK 21.4 million (33.4) and an EBITDA of NOK 6.0 million (22.5) for the second quarter of 2021 (Press release, Biotec Pharmacon, AUG 19, 2021, View Source [SID1234586746]).

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Highlights from Q2 2021

ArcticZymes Technologies (AZT) had Q2 sales of NOK 21.4 million – a reduction of 36% (Q2 2020: NOK 33.4 million)
Coronavirus-related sales are estimated at NOK 4.5 million in Q2 2021 (NOK 11.0 million in Q2 2020)
Gross profit reduced to NOK 21.6 million as a result of lower sales (Q2 2020: NOK 33.0 million)
AZT generated a positive EBITDA of NOK 6.0 million (Q2 2020: NOK 22.5 million)
Cash-flow for Q2 was positive NOK 13.6 million (Q2 2020: NOK 20.4 million) giving a cash balance of NOK 177.0 million (Q2 2020: NOK 56.1 million)
Launched SAN HQ 2.0 at the end of the quarter
Increased ownership in ArcticZymes AS from 96% to 100% by contribution in kind
CEO Jethro Holter comments:

"Second quarter sales performed as expected following a strong Q1 2021. Quarterly volatility is more prominent due to a changing environment relating to the Coronavirus pandemic and associated short-term demands in the supply chain in all market segments ArcticZymes serves.

A new milestone was reached for two consecutive quarters, achieving >100 MNOK in sales revenues for the last 12-months on a quarterly rolling basis. We are delighted to achieve this and now focus our efforts on our next milestone, which is to achieve 120 MNOK in annual sales revenues during 2021."

On August 19, 2021 Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, reported its financial results for the six months ended June 30, 2021 (Press release, Biofrontera, AUG 19, 2021, View Source [SID1234586745]).

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The Biofrontera Group generated revenues of EUR 13,094 thousand in the first half of 2021, a decrease of 19% compared to EUR 16,117 thousand in the first half of 2020. The decrease was due to a one-time payment of EUR 6,000 thousand received by the Company in April 2020 from Maruho Co., Ltd. as part of a licensing agreement. All revenues in 2021 were derived from product sales, an increase of 35% compared to EUR 9,676 thousand in product revenues in the first half of 2020.

"Sales development in the first half of the year shows that we are gradually recovering from the pandemic. Since mid-March, sales have benefited from the easing of pandemic restrictions compared to the previous year. As a result, we were pleased to achieve product sales at pre-crisis levels in recent months," summarized Prof. Dr. Lübbert, CEO of Biofrontera. "Product sales from all markets in Q2 2021 showed an increase in sales of around 126% compared to Q2 2020 and about 10% compared to Q2 2019, prior to the pandemic. In our largest market, the U.S., product revenues from sales of Ameluz and the red-light lamp BF-RhodoLED increased by approximately 130% and about 7% in Q2 2021 compared to Q2 2020 and Q2 2019, respectively. The continued encouraging trend allows us to remain positive going into the second half of the year. From today’s perspective, we therefore confirm the guidance for the full year 2021, which may, however, change in connection with the planned IPO of Biofrontera Inc."

In the U.S., the Company generated revenues from product sales of EUR 8,657 thousand in the first half of 2021, compared to EUR 6,347 thousand in the same period of the previous year, an increase of 36%. This includes EUR 53 thousand (previous year: EUR 157 thousand) from revenues with the product Xepi. While revenues in the USA in January and February 2021 were significantly below those of the previous year due to the pandemic, Biofrontera Group has recorded a considerable year-on-year revenue recovery starting as early as mid-March 2021.

Sales in Germany increased by 15% to EUR 2,718 thousand compared to EUR 2,364 thousand in the prior-year period. In other European countries, sales improved by 78% to EUR 1,719 thousand compared to EUR 965 thousand in the first six months 2020. In this context, the Company recorded a large increase in sales particularly in the second quarter of this year, partly because June sales included the first batch of Ameluz for reintroduction by Galenica AB in the Scandinavian market. Sales from other regions, which included revenues from licensing fees as well as development projects with Maruho (Japan) in the previous year, were not generated in the reporting period (prior-year period: EUR 6,441 thousand).

Cash and cash equivalents of the Biofrontera Group amounted to EUR 32,632 thousand as of June 30, 2021, compared to 16,546 TEUR as of December 31, 2020.

Outlook
Performance in the first six months of 2021 was in line with the Management Board’s expectations. The Management Board therefore maintains its guidance for fiscal year 2021 published on April 12, 2021 in its entirety. Accordingly, the Management Board expects annual revenues between EUR 25 and 32 million as well as EBITDA loss between EUR 11 and 14 million and EBIT loss between EUR 13 and 16 million. However, changes to the Group’ s structure in connection with the planned IPO of Biofrontera Inc. (ad hoc announcement of July 6, 2021) may affect the full-year 2021 guidance of the Biofrontera Group.

The detailed annual forecast is available in the Company’s Annual Report 2020, which is published on the website of Biofrontera AG at View Source

Conference call
Conference calls for shareholders and interested investors will be held on Friday, August 20,
2021, at the following times:

Please dial in 10 minutes ahead of time to ensure a timely start of the conference call.

Biofrontera AG’s half-year report is available for download on the Company’s homepage at View Source

On August 19, 2021 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, reported that it has entered into a third clinical trial collaboration and supply agreement with Merck (known as "MSD" outside the United States and Canada) (Press release, Adagene, AUG 19, 2021, View Source [SID1234586744]). The agreement includes an open-label, dose escalation and expansion clinical study of ADG106 in combination with Merck’s anti-PD-1 KEYTRUDA (pembrolizumab) in advanced or metastatic solid and/or hematological malignancies (ADG106-P2001/KEYNOTE-D12). This clinical study builds on the promising monotherapy and combination therapy data from a Phase I trial of ADG106. Engineered using Adagene’s proprietary NEObody platform technology, ADG106 is a fully human, ligand-blocking, agonistic anti-CD137 immunoglobulin G4 (IgG4) monoclonal antibody (mAb).

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"We are excited to continue our partnership with Merck in a third clinical collaboration that now combines our anti-CD137 agonist, ADG106, with KEYTRUDA," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "While PD-1 drugs have advanced the cancer treatment paradigm, there are still a substantial number of patients with advanced metastatic solid and hematological malignancies who either relapse or are unresponsive, highlighting the need for new approaches. ADG106 targets a unique and highly conserved epitope with a novel mechanism of action and broad species cross reactivity, which enables testing in immunocompetent hosts. In multiple syngeneic models, we have shown a strong additive effect between ADG106 and anti-PD-1/PD-L1 agents."

"We look forward to working closely with Merck and combining ADG106 with KEYTRUDA", said Steven Fischkoff, M.D., interim Chief Medical Officer of Adagene. "Together with our novel mechanism of action, extensive preclinical and strong clinical data generated to date, we believe ADG106 is an ideal candidate to combine with an anti-PD-1 antibody to potentially create a new therapeutic option for cancer patients with unmet medical needs."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About ADG106

ADG106, is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb being developed for the treatment of advanced solid tumors and non-Hodgkin’s lymphoma. CD137 stimulates the immune system to attack cancer cells and is a key driver for long-lasting T cell proliferation and survival. In preclinical studies, we observed that ADG106 had robust antitumor activity and was well tolerated as a single agent and in combination with the existing standard-of-care and other immuno-oncology therapies. ADG106 activates CD137 in a native ligand-like fashion, blocks reverse CD137 ligand signaling, and induces potent cross-linking by Fc receptors. Because of this novel mechanism of action, ADG106 was observed to favorably balance CD137 agonism over CD137-induced liver toxicity, which we believe has potential to address the limitations of other existing anti-CD137 therapies.

ADG106 Phase I trials have been successfully completed with enrollment of nearly 100 patients with advanced solid tumors and non-Hodgkin’s lymphoma in the United States and China. Based on the promising Phase I data, ADG106 is being evaluated in a Phase Ib/II combination study in advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma.

On August 19, 2021 Oasmia reported that Interim report for the period January 1, 2021 – June 30, 2021 (Press release, Oasmia, AUG 19, 2021, View Source [SID1234586742])

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SIGNIFICANT EVENTS DURING THE SECOND QUARTER
In April, Oasmia appointed Dr Reinhard Koenig as Chief Scientific Officer.
In April, Oasmia presented Cantrixil final Phase I data at the 2021 AACR (Free AACR Whitepaper) Annual Meeting.
In April, a Phase 1b trial of Oasmia’s Docetaxel Micellar in advanced prostate cancer was granted ethical committee approval by Swissmedic.
In May, Andrea Buscaglia was appointed as a new Board member by the Annual General Meeting.
In June, following the ethical approval in April, the first Patient was enrolled in the Swiss Group for Clinical Cancer Research (SAKK) Investigator-Initiated Phase 1b trial of Docetaxel Micellar in advanced prostate cancer.
In June, in addition to commercialization rights previously transferred for the rest of Europe, Oasmia also transferred the Nordic commercialization rights for Apealea to Inceptua Group.
In June, Cantrixil positive Phase I trial data were published in the open access oncology journal Cancers.
SECOND QUARTER: APRIL 1, 2021 – JUNE 30, 2021
Consolidated net sales amounted to TSEK 4,596 (254)
Operating profit/loss was TSEK -56,165 (-78,296)
Net profit/loss after tax amounted to TSEK -57,677 (-80,090)
Earnings per share was SEK –0.12 (-0.18)
THE PERIOD: JANUARY 1, 2021 – JUNE 30, 2021
Consolidated net sales amounted to TSEK 4,633 (201,474)
Operating profit/loss was TSEK –97,007 (50,311)
Net profit/loss after tax amounted to TSEK –98,889 (44,615)
Earnings per share was SEK –0.22 (0.10)
CEO REVIEW
Oasmia continued to make progress during the second quarter. In particular, we made strides in progressing our development candidates, announcing a number of important milestones in key programs. All our development candidates target hard-to-treat or late-stage cancers where patients usually have limited treatment options and very poor prognoses.

Final data from a Phase I trial of Cantrixil, the ovarian cancer program we in-licensed from Kazia Therapeutics earlier in the year, was presented in an oral presentation at the prestigious American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April. We also announced publication of this data in the peer-reviewed journal Cancers and it generated substantial interest among oncologists. What is highly interesting from a scientific perspective is the fact that Cantrixil may induce death in ovarian cancer stem cells and sensitize cancer cells to standard chemotherapy, prolonging survival in advanced ovarian cancer patients. There is a lot of work going on to prepare for the initiation of the Phase II trial in the second half of next year. Activities include establishing a clinical advisory board and initiating interactions with the FDA/EMA and of course securing drug supply and validating our Phase 2 trial design.

Also in Q2, the first patient was dosed in an open label, multicenter, single stage Phase 1b clinical trial of Docetaxel micellar in advanced prostate cancer. Docetaxel micellar is a solvent-free formulation of docetaxel, developed to avoid the need for the solubility enhancers in solvent-based docetaxel and mandatory high-dose steroid premedication, while still providing an effective treatment option. The trial is being conducted at major hospitals in Switzerland by the non-profit organization Swiss Group for Clinical Cancer Research (SAKK) which has been conducting clinical trials in oncology since 1965. Prostate cancer is a significant and increasingly prevalent health problem worldwide and is the leading cause of male cancer deaths so there remains a critical need for new therapeutics.

We made great progress in the second quarter on simplifying and focusing our activities. We entered into an agreement to transfer the rights for the commercialization of Apealea (paclitaxel micellar) in the Nordics and Baltics to Inceptua Group. Inceptua already has exclusive rights for the commercialization of Apealea in the rest of Europe, following an agreement signed with Oasmia’s global strategic partner, Elevar Therapeutics, Inc. in 2020. Apealea is our most advanced product and is approved by the European regulatory authorities for use in combination with carboplatin for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. Inceptua is in the process of transferring all licenses and marketing approvals for Apealea in major European markets including Germany and the UK which will delay the full commercialization process across Europe and receipt of royalties. Elevar and Oasmia are confident Inceptua has the network, expertise and commitment to maximize the commercial value of Apealea in Europe. In the US, Elevar is reporting progress in the preparation of the PK study and the Phase 3 clinical trial for Apealea.

Our main objective is to build our oncology pipeline through mergers, acquisitions, or in-licensing. I’m pleased to report we’re evaluating a number of opportunities and we look forward to updating you on any progress.

In addition to building a strong clinical product pipeline in cancer, we are committed to enhancing our proprietary drug delivery technology platform, XR-17, which has already been applied in the creation of Apealea and Docetaxel micellar and has potential in many therapeutic areas. We provided an update on R&D progress during the quarter. XR-18 is in an evaluation process as an enhancement to the XR-17 platform, while XR-19 may feature additional functionalities, specifically encapsulation of multiple APIs to enable combination therapy.

I am a firm believer that a quality team is critical to success. I’m pleased to report that we continued to build the capabilities of the Board and Management in Q2. Dr. Reinhard Koenig has accepted a position as Chief Scientific Officer as of April, bringing expertise in successful product development and commercialization in a number of fields, including oncology. Andrea Buscaglia was elected as new member of the Board of Directors at the Annual General Meeting on 27 May 2021. He brings over 30 years of financial experience in the biopharmaceutical, MedTech, investment banking and accounting sectors.

Working responsibly and ethically is central to the way we do business here at Oasmia and will become more important as we grow. Based on external expertise, we conducted an in-depth internal materiality assessment during Q2 on ESG (environment, social and governance) considerations relevant to us and over the course of the next few months we will decide which kind of key performance indicators and targets in this area we will continue working on and report progress implementing these by year end. Another key aspect of our ethical activities is the fact that we have appointed an external Data Protection Officer (DPO) to fully comply with GDPR regulations.

To increase our visibility and expand our sphere of influence with key stakeholders ever further, and also gain expertise, Oasmia has recently joined the European Federation of Pharmaceutical Industries and Associations (EFPIA). EFPIA is dedicated to working with members to ensure faster and more equitable access to medicines across Europe and create the policy environment in which the European industry can be a world leader in medical innovation.

After a lot of necessary changes since I joined last March I am confident that Oasmia is now well positioned with the vision of becoming one of the leading cancer biopharma company with an innovative oncology pipeline focused on late-stage, hard-to-treat cancers.

I’d like to close by thanking all of my colleagues and board members for their continued dedication and great work and to you, our shareholders, for your support.

On August 19, 2021 Calliditas Therapeutics reported that During the 2nd quarter we significantly ramped up our pre commercial activities in the US following the strengthening of the team announced in Q1 (Press release, Calliditas Therapeutics, AUG 19, 2021, View Source [SID1234586741]). We have added significant internal resources as well as entered into some key partnerships, in order to ensure that we are well positioned to initiate commercialization in Q4, subject to a positive outcome of the FDA approval process.

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During Q2 we also explored avenues to non-dilutive financing by way of a competitive process in order to provide the company with access to additional capital in advance of, as well as post a potential regulatory approval. In parallel we also ran a successful competitive process focused on securing a strong European commercial partner for Nefecon. The result of these processes which was announced in Q3 resulted in over $100m of non- dilutive capital potentially being available to the company, divided between approximately $50m available pre-approval with the remainder becoming available post FDA and EMA approvals and subsequent US commercialization. These processes, together with the accelerated book building procedure raising approximately gross $37m (SEK 324 million) which we completed in Q3, have significantly enhanced our financial strength after the close of Q2."

Renée Aguiar-Lucander, CEO

Summary of Q2 2021
April 1 – June 30, 2021

No net sales were recognized for the three months ended June 30, 2021 and 2020, respectively.
Operating loss amounted to SEK 159.4 million and SEK 66.6 million for the three months ended June 30, 2021 and 2020, respectively.
Loss before income tax amounted to SEK 165.2 million and SEK 61.3 million for the three months ended June 30, 2021 and 2020, respectively.
Loss per share before and after dilution amounted to SEK 3.20 and SEK 1.50 for the three months ended June 30, 2021 and 2020, respectively.
Cash amounted to SEK 709.3 million and SEK 1,459.6 million as of June 30, 2021 and 2020, respectively.
Significant events during Q2 2021, in summary
In April 2021, Calliditas was granted accelerated assessment procedure by the European Medicine Agency’s (EMA) Committee for Human Medicinal Products (CHMP) for Nefecon, reducing the maximum timeframe for review of the application for marketing authorization. If approved, Nefecon could be available to patients in Europe in first half of 2022.
In April 2021, Calliditas announced that the FDA accepted the submission and granted Priority Review for the NDA for Nefecon. The FDA have set a Prescription Drug User Fee Act (PDUFA) goal date of September 15, 2021. Subject to approval, this would enable commercialization of Nefecon in the US in Q4, 2021.
In May 2021, Calliditas announced that the company submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Nefecon.
Significant events after the end of reporting period, in summary
In July 2021, Calliditas signed a loan facility of up to the EUR equivalent of $75 million with Kreos Capital.
In July 2021, Calliditas and STADA Arzneimittel AG entered into a license agreement to register and commercialize Nefecon in the European Economic Area (EEA) member states, Switzerland and the UK valued at a total of 97.5 million EUR ($115m) in initial upfront and potential milestone payments, plus royalties.
In August 2021, Calliditas received FDA fast track designation for setanaxib in PBC.
In August 2021, Calliditas completed an accelerated book building procedure and resolved on a directed share issue in the amount of 2.4 million shares, raising proceeds of SEK 324.0 million before transaction costs.
Investor presentation August 19, 14:30 CET
Audio cast with teleconference, Q2 2021, August 19, 2021, 14:30 (Europe/Stockholm)

Financial calendar
Interim Report for the period January 1 – September 30, 2021 November 18, 2021

Year-end Report for the period January 1 – December 31, 2021 February 24, 2022