On April 12, 2021 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its collaborators presented positive preclinical data for the combination of TUSC2 immunogene therapy (REQORSA) in combination with chemotherapy and immunotherapies for the treatment of non-small cell lung cancer (NSCLC) (Press release, Genprex, APR 12, 2021, View Source [SID1234577913]). Collaborators also presented positive preclinical data for the use of REQORSA in combination with targeted therapies for the treatment of NSCLC. These data were presented in two presentations at the 2021 American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting. The TUSC2 gene is a tumor suppressor gene and is the active agent in REQORSA.

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"We are pleased to have these positive data that provide further support for the therapeutic potential of REQORSA in combination with immunotherapies and targeted therapies in NSCLC presented before an audience of the world’s leading cancer researchers. These data are particularly encouraging as we look to initiate our upcoming combination Acclaim-1 and Acclaim-2 clinical trials of REQORSA in NSCLC," said Rodney Varner, President and Chief Executive Officer of Genprex. "We know that many patients inevitably develop resistance to immune checkpoint blockade therapy or EGFR-TKI therapy. These data show that REQORSA in combination with immunotherapies and targeted therapies may provide enhanced efficacy in NSCLC that has become resistant to these regimens, offering hope to a large patient population who currently has limited treatment options."

Featured Genprex-supported posters presented at AACR (Free AACR Whitepaper) 21 include:

Oral Presentation:
Session: MS.IM02.02 – Overcoming Resistance in the Tumor Microenvironment: Novel Immunomodulatory Agents

Title: "TUSC2 immunogene therapy enhances efficacy of chemo-immune combination therapy and induces robust antitumor immunity in KRAS-LKB1 mutant NSCLC in humanized mice"

Poster Number/Channel: #76/Channel 03

Presentation Date/Time: April 10, 2021 from 2:50-3:00 p.m. ET

Presenters: Ismail M. Meraz, Mourad Majidi, RuPing Shao, Feng Meng, Min Jin Ha, Elizabeth Shpall, Jack A. Roth. University of Texas MD Anderson Cancer Center, Houston, TX

Poster Presentation:
Session: PO.ET03.01 – Drug Resistance in Molecular Targeted Therapies

Title: "Overcoming resistance to osimertinib by TUSC2 gene therapy in EGFR mutant NSCLC"

Poster Number: #1105

Presentation Date/Time: April 10, 2021 from 8:30 a.m. – 11:59 p.m. ET

Presenters: Ismail M. Meraz, Mourad Majidi, RuPing Shao, Lihui Gao, Meng Feng, Huiqin Chen, Min Jin Ha, Jack A Roth

The first presentation, entitled "TUSC2 immunogene therapy enhances efficacy of chemo-immune combination therapy and induces robust antitumor immunity in KRAS-LKB1 mutant NSCLC in humanized mice," showed that the triple combination of chemotherapy, immunotherapy (immune checkpoint blockade) and REQORSA demonstrated strong antitumor efficacy and induced robust antitumor immunity in KRAS-LKB1 (KL)-mutant NSCLC in clinically relevant humanized mice models.

In this study, researchers evaluated the antitumor immune response of a chemo-immunotherapy combination with REQORSA on highly metastatic KL-mutant human lung cancer in humanized mice. Humanized mice were first treated with REQORSA, immunotherapy nivolumab (Opdivo), or the combination. The results showed synergistic antitumor activity with the combination. Next, humanized mice were treated with REQORSA, immunotherapy pembrolizumab (Keytruda), or the combination. When REQORSA was added to the chemotherapy and immune checkpoint blockade combination, metastases regression was significantly greater than either REQORSA, REQORSA and pembrolizumab, or chemotherapy and pembrolizumab treatments.

"KRAS is a frequent genomic driver in lung adenocarcinoma,", said Michael Redman, Executive Vice President and Chief Operating Officer of Genprex. "LKB1 (also known as STK11) is a distinct subgroup of KRAS-mutants and is the most prevalent genomic driver of resistance to PD-1 blockade in KRAS-mutant lung cancer."

The second poster, entitled "Overcoming resistance to osimertinib by TUSC2 gene therapy in EGFR-mutant NSCLC," showed that REQORSA in combination with targeted therapy osimertinib (Tagrisso) demonstrated synergistic antitumor efficacy in EGFR mutant osimertinib resistant NSCLC tumors in H1975-OsiR isogenic tumors. Researchers also found that the upregulation of PDK1 was associated with osimertinib resistance.

In this study, researchers developed an osimertinib resistant H1975-OsiR isogenic cell line through continuous exposure to osimertinib. Xenograft tumors from both H1975-parental and H1975-OsiR cells were developed in NSG mice and were treated with osimertinib. Synergistic antitumor activity of REQORSA and osimertinib was found in H1975-OsiR tumors. The combinations showed a robust antitumor effect compared with single agent treatment groups. Reverse phase protein array (RPPA) data showed that PDK1 was significantly upregulated in the REQORSA and osimertinib group when compared with either control, osimertinib alone or REQORSA alone treated H1975-OsiR tumors, indicating that PDK1 may be associated with osimertinib resistance. No PDK1 inhibitor effect was found in the REQORSA treated group, implicating the specific role of PDK1 in osimertinib resistance.

On April 12, 2021 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported the presentation of two posters on the company’s clinical and preclinical oncology programs at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, taking place April 10-15, 2021 (Press release, Alpine Immune Sciences, APR 12, 2021, View Source [SID1234577912]).

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CT213: NEON-1: A First-in-Human Phase I Open-Label Study of ALPN-202, a Conditional CD28 Costimulator and Dual Checkpoint Inhibitor, in Advanced Malignancies

Dr. Mark Voskoboynik from Nucleus Network and The Alfred Hospital in Melbourne, Australia, presented a Trials in Progress poster describing the ongoing first-in-human, phase 1 clinical trial involving monotherapy with ALPN-202, the company’s lead oncology program.
The trial, NEON-1, includes separate parts for dose escalation and expansion cohorts, and is enrolling patients with advanced solid tumors or lymphoma. Dose escalation continues to progress, with no dose-limiting toxicities to date.
P1740: Engineered Variant Domain Fusion Proteins Provide Checkpoint Inhibition and Tumor Antigen Dependent CD28 Costimulation Resulting in Potent Anti-Tumor Immunity

Alpine researchers demonstrated the use of directed evolution to engineer novel variant immunoglobulin domain (vIgD) Fc fusion proteins that enable tumor antigen-dependent CD28 costimulation.
The fusion proteins targeted the PD-L1 or HHLA2 tumor antigens, and demonstrated potent efficacy in antigen-positive tumor models in vitro and in vivo.
"Together, these presentations summarize the potential for an exciting, emerging CD28 costimulation portfolio," said Stanford Peng, MD, PhD, Alpine’s President and Head of Research and Development. "We look forward to the opportunity to present initial clinical data from NEON-1 at an upcoming scientific meeting and are optimistic about the potential to advance one or more of our preclinical programs toward the clinic in the near future."

Full abstracts are available on the AACR (Free AACR Whitepaper) Virtual Annual Meeting website and posters for both presentations are available on the Scientific Publications page of Alpine’s website.

About Alpine’s Directed Evolution Platform

Alpine’s directed evolution platform engineers native immune proteins, primarily of the immunoglobulin or tumor necrosis factor (receptor) superfamilies, into novel functional domains: variant immunoglobulin domains (vIgDs) and/or variant TNF domains (vTDs), respectively. These domains have acquired unique functional properties designed to benefit patients with cancer or inflammatory diseases.

About ALPN-202

ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor with the potential to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. NEON-1 (NCT04186637), a Phase 1 study of ALPN-202 in patients with advanced malignancies, is currently enrolling. Alpine is also targeting the initiation of NEON-2, a Phase 1 combination study of ALPN-202 and a PD-1 inhibitor, later this year.

On April 12, 2021 NuCana plc (NASDAQ: NCNA) reported the presentation of five posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 being held virtually April 9 to 14, 2021 (Press release, Nucana BioPharmaceuticals, APR 12, 2021, View Source [SID1234577911]). Data from all three of NuCana’s ProTides in clinical development were presented. Summaries of the posters are described below.

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NUC-3373

NuCana presented two posters on NUC-3373, its ProTide transformation of the active anti-cancer metabolite of 5-fluorouracil (5-FU), a very widely used anti-cancer drug. NUC-3373 has been designed to overcome the main challenges associated with 5-FU and capecitabine, including cancer-resistance mechanisms, the generation of toxic metabolites and unfavorable pharmacokinetic profile.

Poster Title: NUC-3373, a targeted inhibitor of thymidylate synthase, in patients with advanced colorectal cancer

This poster describes further encouraging interim data from 38 patients with metastatic colorectal cancer. In this difficult-to-treat group, who had received a median of four prior lines of therapy, NUC-3373, with or without leucovorin, demonstrated a 62% disease control rate (defined as stable disease lasting more than 8 weeks) in the efficacy-evaluable population. Three patients experienced reductions in their target lesions of 40%, 28% and 15% and several patients achieved a longer progression-free survival on NUC-3373 than they had on their prior therapy. NUC-3373 also continues to demonstrate a favorable safety profile with no FBAL or FUTP-associated Grade 3 or 4 toxicities, such as hand-foot syndrome, GI or hematological adverse events.

Poster Title: NUC-3373-induced DAMPs release in CRC cells promotes natural killer cell activation

The second NUC-3373 poster showed that NUC-3373-treated colon cancer cells are able to activate a natural killer (NK) cell response. NUC-3373 was shown to induce the release of damage associated molecular patterns (DAMPs) which may restore NK cell-mediated immune responses by reducing inhibitory signals. Thus, NUC-3373 has the potential to evoke immunogenic cell death and may enhance the clinical utility of immunotherapy agents.

NUC-7738

NuCana presented two posters on NUC-7738, a ProTide transformation of a novel nucleoside analog, 3’-deoxyadenosine or 3’-dA. NUC-7738, which has several potential anti-cancer mechanisms of action, is being evaluated in a Phase I study in patients with advanced solid tumors who have exhausted all standard therapies.

Poster Title: NUC-7738, a novel ProTide transformation of 3’-deoxyadenosine, in patients with advanced solid tumors

The first poster describes additional interim data from the ongoing Phase I study. These data demonstrate NUC-7738’s encouraging anti-cancer activity and favorable tolerability profile. Three case studies were described detailing patients who achieved tumor reductions and prolonged stable disease on NUC-7738.

Poster Title: From bench to bedside: Using ProTide chemistry to transform 3’-deoxyadenosine into the novel anti-cancer agent NUC-7738

The second poster describes how NUC-7738 was designed to overcome the key cancer resistance mechanisms which have prevented the clinical development of 3’-dA. NUC-7738 was shown to efficiently generate high and prolonged intracellular levels of the active anti-cancer metabolite, 3’-dATP, and to cause cell death by activation of apoptotic pathways, as well as through inhibition of NFkB nuclear translocation.

Acelarin

Poster Title: NUC-1031 causes incorporation of fluorinated deoxycytidine into DNA, inducing persistent damage in biliary tract cancer cells

NuCana presented a poster that further demonstrated Acelarin’s activity in biliary tract cancer cells. Specifically, the poster described how Acelarin (NUC-1031) is converted to the active anti-cancer metabolite (dFdCTP) and demonstrated that it is incorporated into DNA, inducing persistent double-strand breaks. This leads to cell cycle arrest and DNA damage resulting in apoptosis in biliary tract cancer cells.

Abstracts and full session details can be found at www.aacr.org

On April 12, 2021 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of resistance in cancer, reported four preclinical poster presentations at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) virtual annual meeting (Press release, ORIC Pharmaceuticals, APR 12, 2021, View Source [SID1234577910]).

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ORIC-101: Glucocorticoid Receptor (GR) Antagonist
ORIC-101 is a potent and selective GR antagonist, with two distinct mechanisms of action being evaluated in two Phase 1b trials in combination with: (1) Abraxane (nab-paclitaxel) in advanced or metastatic solid tumors and (2) Xtandi (enzalutamide) in metastatic prostate cancer.

Key findings of the presentation:

GR upregulation and activation, an established resistance mechanism for antiandrogens, may drive resistance when antiandrogens are combined with AKT inhibitors.
ORIC-101 was able to overcome this resistance and restore antitumor activity in preclinical prostate cancer cell lines.
Poster Presentation:

GR antagonist ORIC-101 overcomes GR-mediated resistance to the combination of AR and AKT inhibition in preclinical prostate cancer cell lines (Abstract 1420)
ORIC-533: CD73 Inhibitor
ORIC-533 is a highly potent, orally bioavailable CD73 inhibitor and has demonstrated greater potency in preclinical studies compared to an antibody approach and other small molecule CD73 inhibitors.

Key findings of the presentation:

Nanomolar concentrations of ORIC-533 efficiently rescued cytotoxic T-cell function in the presence of high AMP concentrations, reflective of levels observed in tumors.
Inhibitors of adenosine receptors A2A or A2A/B were only able to rescue CD8+ T-cell function in the context of low micromolar AMP, thus may be ineffective in tumors with moderate or high AMP and adenosine levels.
ORIC-533 has potential best-in-class properties in reversing immunosuppression in tumors.
Poster Presentation:

Blocking adenosine production with ORIC-533, a CD73 inhibitor with best-in-class properties, reverses immunosuppression in high-AMP environments (Abstract LB-163)
ORIC-944: PRC2 Inhibitor
ORIC-944 is a potent and selective allosteric inhibitor of polycomb repressive complex 2 (PRC2) and targets its regulatory embryonic ectoderm development (EED) subunit.

Key findings of the presentation:

ORIC-944 has potential best-in-class drug properties compared to first generation PRC2 inhibitors, including a clean CYP profile.
ORIC-944 demonstrated superior activity compared to an EZH2 inhibitor in an in vivo DLBCL model.
ORIC-944 demonstrated strong tumor growth inhibition as a single agent with once daily dosing in both enzalutamide-responsive and enzalutamide-resistant in vivo prostate cancer models.
Poster Presentation:

ORIC-944, a potent and selective allosteric PRC2 inhibitor, demonstrates robust in vivo activity in prostate cancer models (Abstract 1131).
ORIC-114: EGFR/HER2 Inhibitor
ORIC-114 is a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations.

Key findings of the presentation:

ORIC-114 is highly selective for the EGFR family of receptors with superior kinome selectivity compared to other exon 20 inhibitors.
ORIC-114 demonstrated low nanomolar potency across exon 20 insertion variants in biochemical and cell-based assays.
Significant tumor regression was observed in multiple EGFR exon 20 patient-derived xenograft models using once daily oral administration of ORIC-114.
ORIC-114 displayed superior brain exposure relative to other compounds targeting exon 20 insertion mutations, and greater activity compared to other EGFR inhibitors in an intracranial NSCLC EGFR mutant xenograft model.
Poster Presentation:

ORIC-114, a brain penetrant, orally bioavailable, irreversible inhibitor selectively targets EGFR and HER2 exon20 insertion mutants and regresses intracranial NSCLC xenograft tumors (Abstract 1466).

On April 12, 2021 Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, reported its consolidated results for the fiscal year ended December 31, 2020 (Press release, Biofrontera, APR 12, 2021, View Source [SID1234577909]). At the same time, the Company provided an overview of current operational and clinical developments.

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Key financial figures FY2020

Revenue decreased by 3% to EUR 30.3 million compared to EUR 31.3 million in 2019;
Loss from operations amounted to EUR 7.6 million compared to a loss of EUR 23.4 million in 2019;
Net loss before tax was EUR 12.7 million compared to a loss of EUR 4.8 million in 2019;
Cash and cash equivalents amounted to EUR 16.5 million as of December 31, 2020, compared to EUR 11.1 million as of December 31, 2019.
Operational and clinical developments in 2020 and year-to-date

Reorganization of the US business and restructuring of Biofrontera’s global sales organization;
Exclusive license and supply agreement with Maruho Co., Ltd. for the development and commercialization of Ameluz for all indications in East Asia and Oceania incl. an immediate one-time payment of EUR 6 million;
Approval from the European Commission for the label extension of Ameluz for the treatment of actinic keratosis (AK) on the entire body;
Completion of the pharmacokinetics study and submission of the application for amendment of the product information to the U.S. Food and Drug Administration (FDA) to allow the simultaneous use of three tubes of Ameluz per treatment
Submission of the approval application to the FDA for a larger red-light source, the BF-RhodoLED XL, for photodynamic therapy (PDT) in combination with Ameluz.
"Overall, we managed to steer Biofrontera well through a very challenging year – despite the decline in sales in our largest sales market, the USA. Early implemented cost-saving measures as well as cash inflows from the down payment received for the license agreement with Maruho Co., Ltd. and from the fully placed convertible bond in August successfully offset the negative impact caused by the decline in product sales. In this context, the strong fourth quarter also saw us reach operational breakeven at Group level for the first time," explained Prof. Dr. Lübbert, CEO of Biofrontera. "Encouragingly, sales in Germany continued to grow even in the pandemic year, driven by the EU approval extension for daylight PDT granted in 2018. We also recorded future-oriented strategic successes on the regulatory and clinical side. The EU approval extension for Ameluz received in March, which now allows PDT treatment of mild and moderate actinic keratoses not only on the head but also on the entire body on label provided a further unique selling point for Ameluz. The completion of the pharmacokinetics study, which tested the safety of PDT with the simultaneous application of up to three tubes of Ameluz. represented another major milestone for us. The study report was submitted to the FDA in February 2021 with the aim of removing a restriction in the product information on the use of only one tube per treatment. This is a prerequisite for the treatment of larger body areas with several tubes of Ameluz as well as for the alignment of reimbursement modalities compared to the competitor product in the USA and thus an increase in the competitiveness of Ameluz in this important market. Furthermore, to complement this progress with an optimized light source, Biofrontera has developed a new lamp model, the BF-RhodoLED XL, which can be used to illuminate larger skin areas."

in EUR thousands 2020 2019 Q4 2020 Q4 2019
Total revenue 30,346 31,265 9,516 12,206
Research and development costs (4,789 ) (4,636 ) (1,386 ) (1,421 )
General and administrative costs (9,150 ) (16,275 ) (2,268 ) (4,167 )
Sales costs (20,482 ) (28,856 ) (4,142 ) (8,221 )
Profit (loss) from operations (7,611 ) (23,377 ) 753 (2,284 )
Other (expenses) and income (2,418 ) 21,184 (788 ) 356
Net loss before tax (12,697 ) (4,777 ) (1,062 ) (2,253 )
Outlook and guidance 2021
The Biofrontera Group provides the following guidance for the full year 2021, which reflects the Group’s assessment regarding the timing and speed of recovery from the pandemic. We expect that due to the vaccination programs, the pandemic will slowly subside in our key sales markets, resulting in a growth momentum in the second half of 2021. However, our sales and thus business activities largely depend on the further infection trend and the associated easing of containment measures.

Respecting these circumstances, the Group expects revenue from product sales of EUR 25 to 32 million in fiscal year 2021.

EBITDA and EBIT will be introduced as key performance indicators in our reporting starting in 2021. Both have become established internationally as target metrics and will replace the previously reported key performance indicator result from operating activities.
Based on the above assumptions, the Biofrontera Group expects EBITDA (loss) to be between EUR (11) million and EUR (14) million and EBIT (loss) between EUR (13) million and EUR (16) million in 2021.

From today’s perspective, the Biofrontera Group has sufficient liquidity available for the coming 12 months, taking into account the earnings expectations for 2021, cash on hand in the amount of EUR 16.5 million as of December 31, 2020 as well as the capital increase carried out in February 2021.

Commercialization of Ameluz in the USA

Revenues generated from sales in the U.S.A. were EUR 16.6 million, compared to EUR 23.3 million in 2019, representing a decrease of 29% year-on-year. Revenues include EUR 0.3 million from product sales of Xepi (previous year: EUR 0.6 million).

As reported above, Biofrontera was directly affected by the global coronavirus crisis from mid-March 2020. From that point on, rising infection rates and the official recommendation of the American Academy of Dermatology to provide patients with remote diagnosis and treatment whenever possible led to significantly declining patient numbers and extensive, albeit temporary, practice closures. In the wake of this, our U.S. sales in particular declined sharply. As a result, the wholly owned US-subsidiary Biofrontera Inc. initiated extensive cost-saving measures, including headcount reductions. After sales of our products initially fell to almost zero in April 2020, we observed a slow recovery of our U.S. business again in the summer and later the first signs of stabilization in line with the usual seasonality. In many parts of the U.S., doctors’ offices reopened during the second half of the year, at least in part, and patients showed increasing willingness to undergo treatment for actinic keratosis. The fourth quarter of 2020 again experienced a seasonally strong increase in sales, but overall sales in this quarter also remained below the level of the previous year, in part due to the so-called second wave of coronavirus infections.

Commercialization of Ameluz in Europe
Revenue from product sales in Germany increased by approximately 11% to EUR 5.1 million in fiscal 2020 compared to EUR 4.6 million in 2019, despite Corona-related restrictions. In the rest of Europe, the pandemic led to a decline in sales, with product sales of EUR 2.1 million compared to EUR 2.6 million in the prior-year period.

In Germany our sales team successfully leveraged an approval extension granted in March 2020 to include the treatment of actinic keratoses on the body and extremities, as well as recent study results, to promote the benefits of Ameluz to dermatologists even during the crisis. The advantages of daylight-PDT, which could be performed in good weather without immediate contact with doctors, became particularly evident during the summer months. Spain experienced a very positive sales development at the beginning of the year prior to the outbreak of the pandemic, after which business declined sharply due to the strict lockdown regulations there. In the United Kingdom, sales remained at a low level for almost the entire year due to the pandemic.

Regional expansion of the commercialization of Ameluz
On March 13, 2020, the Company announced that it had signed a non-binding term sheet for an exclusive license and supply agreement with medac GmbH Sp. z o.o., Warsaw, the Polish subsidiary of medac Gesellschaft für klinische Spezialpräparate mbH, for the commercialization of Ameluz and BF-RhodoLED in Poland. A final agreement is expected to be signed in 2021.

On April 20, 2020, Biofrontera concluded an exclusive license and supply agreement with Maruho Co., Ltd. (Maruho) for the development and commercialization of Ameluz for all indications in East Asia and Oceania. As part of the licensing agreement, Biofrontera received a one-time payment of EUR 6.0 million from Maruho. In addition, Biofrontera will receive future payments pending on the achievement of certain regulatory and sales milestones as well as royalties on sales.

On December 7, 2020, the Company announced that its wholly owned subsidiary Biofrontera Pharma GmbH and Galenica AB, Malmö, Sweden (Galenica AB), signed an exclusive license and supply agreement for the commercialization of both Ameluz and BF-RhodoLED in in Schweden, Norwegen, Dänemark, Finnland und Island. According to the agreement, Galenica AB receives exclusive distribution rights for these regions and a right of first refusal for commercialization in the Baltic States. After the amicable termination of the agreement between Biofrontera and the former distribution partner for these regions, Galenica AB is now working towards the reintroduction of the products in Scandinavia by mid-2021.

Regulatory and clinical progress

Based on a positive assessment by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on February 3, 2020, the European Commission granted the formal label extension for Ameluz on March 10, 2020, which now also covers the treatment of mild and moderate actinic keratoses (AK) on the extremities and trunk/neck with photodynamic therapy (PDT).

In addition, the results of the follow-up phase of the clinical comparative study on daylight PDT with Ameluz and Metvix were included in the product information (SmPC). Ameluz showed significantly lower recurrence rates after 12 months at 19.5% compared to competitor Metvix at 31.2%.

In October 2020, the clinical phase of the pharmacokinetics study (PK study) in the USA was concluded. The PK study tested the safety of PDT for the treatment of actinic keratoses on larger or multiple areas with the simultaneous use of up to three tubes of Ameluz. The study report was submitted to the FDA in February 2021 with the objective of removing a restriction in the prescribing information for the use of only one tube per treatment.

In addition, the development of the new BF-RhodoLED XL lamp, which enables the use of Ameluz across larger skin areas, was completed. The application for approval was submitted to the FDA in March 2021.

Patient recruitment for the Phase III trial for the treatment of basal cell carcinoma (BCC) with Ameluz in the USA continued in 2020 despite the pandemic.

Conference call
Conference calls for shareholders and interested investors will be held on Tuesday, April 13, 2021, at the following times: