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 Vyant Bio, Inc., (Nasdaq: VYNT), a leading biotech company discovering new therapeutics for neurological diseases and hard-to-treat cancers, and Cyclica, Inc., the partner of choice for data driven drug discovery, reported a non-exclusive strategic collaboration combining Vyant Bio’s patient-derived complex organoid biology alongside Cyclica’s proteome-wide, Artificial Intelligence ("AI") enabled discovery platform to identify new treatments for CDKL5 Deficiency Disorder ("CDD"), a severe neurodevelopmental epilepsy disorder with no effective treatments or cure (Press release, Cyclica, AUG 19, 2021, View Source [SID1234586760]).

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Vyant Bio’s human-first approach to novel drug discovery incorporates patient biology into the earliest steps of the process with highly functional, disease-based neural organoids, while Cyclica’s proprietary machine learning platforms marry knowledge and structure-based approaches to find novel targets, uncover new uses for existing drugs, and design new molecules with therapeutic potential. Combined, the technologies aim to identify, validate, and progress new targets as well as new and existing compounds for streamlined and de-risked CDD-based drug discovery.

Vyant Bio has deep experience in using human-based disease biology to ensure that early findings are directly related to the patients destined to receive treatments. They have incorporated CDD-based neural organoids into their platforms and are using initial findings to build a robust drug discovery pipeline.

"Last quarter we had launched commercial stage, novel disease models for CDD," stated Jay Roberts, CEO of Vyant Bio. "With this strategic collaboration we have the advantage of leveraging Cyclica’s demonstrated ability to identify unique relationships between compounds, proteins, cellular pathways, and diseases, as well as their AI-based drug discovery. These complementary technologies, combined with our additional pre-clinical expertise, will accelerate the identification of potential medicines and therapies to help children with this devastating disease. We continue to be focused on rapidly identifying small and large molecule therapeutics to treat central nervous system and oncology-related diseases. "

Naheed Kurji, Co-Founder, CEO, and President of Cyclica, shares his enthusiasm for the partnership adding "Cyclica is building the biotech pipeline of the future, and partnerships with leading organizations like Vyant Bio are key to streamline the discovery of better medicines. Given the unique synergy of Vyant Bio’s in vitro screening approach to human disease and Cyclica’s multi-targeted and multi-objective drug discovery platform, we aim to bring novel therapeutics to patients suffering from CDD."

On August 19, 2021 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported the pricing of an underwritten public offering of 35,294,117 shares of common stock or common stock equivalents (which includes pre-funded warrants to purchase shares of common stock in lieu of shares of common stock) and investor warrants to purchase up to an aggregate of 35,294,117 shares of common stock (Press release, Sonnet BioTherapeutics, AUG 19, 2021, View Source [SID1234586778]). Each share of common stock (or pre-funded warrant in lieu thereof) is being sold together with one investor warrant to purchase one share of common stock at a combined offering price of $0.85, for total gross proceeds of approximately $30.0 million, before underwriting discounts and commissions and offering expenses payable by Sonnet. The investor warrants have an exercise price of $0.85 per share. The offering is expected to close on or about August 24, 2021, subject to the satisfaction or waiver of customary closing conditions.

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BTIG is acting as the sole book-running manager in connection with the offering and Chardan is acting as lead manager.

The Company has also granted the underwriters a 30-day option to purchase up to 5,294,117 additional shares of its common stock and/or investor warrants to purchase up to 5,294,117 additional shares of its common stock, in any combination thereof, at the public offering price, less underwriting discounts and commissions, to cover over-allotments, if any.

Sonnet anticipates using the net proceeds from the offering for research and development, including clinical trials, working capital and general corporate purposes.

The securities will be offered pursuant to a registration statement on Form S-1, as amended (File No. 333-258092), which was declared effective by the Securities and Exchange Commission (the "SEC") on August 19, 2020. The offering is being made solely by means of a prospectus. A preliminary prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus and, when available, copies of the final prospectus relating to this offering can be obtained at the SEC’s website at www.sec.gov or from BTIG, LLC, Attention: Equity Capital Markets, 65 East 55th Street, New York, NY 10022, by calling (212) 593-7555 or by e-mail at [email protected].

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

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 Biocept (Nasdaq: BIOC), a leading provider of molecular diagnostic assays and services, reported that new data show the company’s cerebrospinal fluid assay, CNSide, detected tumor cells and identified actionable mutations in lung cancer patients with leptomeningeal carcinomatosis, allowing for targeted treatment decisions that may improve outcomes and extend life expectancy (Press release, Biocept, AUG 19, 2021, View Source [SID1234586761]). The study will be presented as a poster at the Third Annual Conference on Brain Metastases hosted by the Society for Neuro-Oncology (SNO), being held virtually Aug. 19-20, 2021.

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More than 198,000 patients are diagnosed with non-small cell lung cancer (NSCLC) each year. An estimated 3-9% of those patients will develop leptomeningeal carcinomatosis (LMC), a complication in which the cancer spreads to the membranes surrounding the brain and spinal cord. LMC is typically diagnosed through clinical evaluation, imaging and cytology, which have limited sensitivity. When left untreated, the average patient life expectancy is just four to six weeks.

The retrospective study, conducted at the University of Utah Huntsman Cancer Institute, used Biocept’s CNSide assay to detect and analyze tumor cells in the cerebrospinal fluid of 15 unique patients. Of the samples analyzed, CNSide detected tumor cells in 100% of samples with LMC, while cytology detected tumor cells in just 40% of the samples. CNSide also identified actionable biomarkers in tumor cells, which allowed oncologists to make targeted treatment decisions that reduced debilitating symptoms and extended patient lives by more than three years in some cases. The study results suggest that CNSide is more sensitive than cytology, and survival of patients with LMC can be prolonged if an actionable target is identified and treated.

"LMC is a devastating diagnosis for patients and, quite often, hospice is the only recommended course of action," said Wallace Akerley, M.D., University of Utah Huntsman Cancer Institute, and lead study investigator. "However, we now have targeted therapies that can improve and dramatically extend the lives of patients with LMC who have a treatable mutation. This study shows that using CNSide to interrogate the cerebrospinal fluid for actionable mutations provides the information needed to determine the appropriate treatment for patients with LMC. With the right therapy, we have the ability to restore quality of life and extend life expectancy for many patients."

"Identifying actionable mutations is critical for treating patients with LMC," said Michael C. Dugan, M.D., Biocept’s Chief Medical Officer and Medical Director. "CNSide has demonstrated the ability to reliably detect and analyze tumor cells in the cerebrospinal fluid that may not be found in blood or tissue samples. The specific molecular targets identified in these tumor cells can help guide a physician’s choice of newer, more effective therapies and inform the response to therapy in a way that can really help these patients see an improvement of symptoms and live significantly longer lives."

The study, titled "Beyond Cytology – A Single Institution Experience Using CNSide for Diagnosing and Monitoring Treatment Response in Non-Small Cell Lung Cancer Patients with Leptomeningeal Carcinomatosis (LMC)," can be accessed here.